WO2021038444A1 - Pneumatic pressure massage device - Google Patents

Pneumatic pressure massage device Download PDF

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Publication number
WO2021038444A1
WO2021038444A1 PCT/IB2020/057941 IB2020057941W WO2021038444A1 WO 2021038444 A1 WO2021038444 A1 WO 2021038444A1 IB 2020057941 W IB2020057941 W IB 2020057941W WO 2021038444 A1 WO2021038444 A1 WO 2021038444A1
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WO
WIPO (PCT)
Prior art keywords
pneumatic pressure
massage therapy
pad
manifold
tissue site
Prior art date
Application number
PCT/IB2020/057941
Other languages
French (fr)
Inventor
Luke Perkins
Jonathan G. REHBEIN
Original Assignee
Kci Licensing, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Kci Licensing, Inc. filed Critical Kci Licensing, Inc.
Publication of WO2021038444A1 publication Critical patent/WO2021038444A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H9/00Pneumatic or hydraulic massage
    • A61H9/005Pneumatic massage
    • A61H9/0057Suction
    • A61F13/05
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H9/00Pneumatic or hydraulic massage
    • A61H9/005Pneumatic massage
    • A61H9/0071Pneumatic massage by localized pressure, e.g. air streams or jets
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/01Constructive details
    • A61H2201/0111Constructive details watertight
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/01Constructive details
    • A61H2201/0119Support for the device
    • A61H2201/013Suction cups
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/16Physical interface with patient
    • A61H2201/1683Surface of interface
    • A61H2201/1688Surface of interface disposable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/16Physical interface with patient
    • A61H2201/1683Surface of interface
    • A61H2201/169Physical characteristics of the surface, e.g. material, relief, texture or indicia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50Control means thereof
    • A61H2201/5005Control means thereof for controlling frequency distribution, modulation or interference of a driving signal
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50Control means thereof
    • A61H2201/5007Control means thereof computer controlled
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50Control means thereof
    • A61H2201/5058Sensors or detectors
    • A61H2201/5071Pressure sensors

Definitions

  • the invention set forth in the appended claims relates generally to massage devices and systems and more particularly, but without limitation, to pneumatic massage devices that may induce massage through direct application of pneumatic pressure to a tissue site.
  • embodiments may relate to massage devices using pneumatic pressure, which for example may be capable of providing massage therapy at various settings via one or more massage therapy pads attached to the skin.
  • the pneumatic pressure may be directly applied to the skin or tissue site via the massage therapy pads, in order to provide the massage effect.
  • the one or more massage therapy pads may each comprise a porous manifold within a top cap.
  • the porous manifold for each pad may comprise porous foam, porous fabric, and/or a plurality of cells.
  • the cap may be configured to seal the manifold (e.g. with respect to pneumatic air pressure) except for an exposed surface (e.g. which would typically be directed towards the tissue site).
  • a gel layer configured to adhere and/or seal the pad to the skin, may span the exposed surface.
  • the gel layer may be configured, for example with a plurality of apertures, to allow fluid communication of pneumatic pressure between the manifold (e.g. the interior of the cap) and the tissue site.
  • a pneumatic pressure source may be fluidly coupled to and/or may provide pneumatic pressure to the one or more massage therapy pads (e.g. into the cap and/or in fluid communication with the manifold).
  • a controller may apply or control the pneumatic pressure, which may be positive pressure, negative pressure, and/or both, at multiple intensity levels, multiple therapy patterns, and/or at multiple pads.
  • cell manifold embodiments may be configured to allow for independent pneumatic pressurization of each cell (e.g. with each cell sealed from the other cells).
  • the pneumatic pressure may directly massage the tissue site/skin.
  • the massage pad may massage the tissue site by direct contact of the pneumatic pressure on the tissue site, for example through the apertures in the gel layer.
  • some massage therapy pads may comprise a manifold; a cap enclosing the manifold on all but an exposed surface of the manifold; and a port configured for communication of pneumatic pressure into the cap.
  • the cap may be substantially gas impermeable.
  • Some embodiments may further comprise an edge seal configured to seal a perimeter of the exposed surface and/or to removably attach the cap to the tissue site.
  • the edge seal may comprise a gel seal located around the perimeter.
  • Other embodiments may further comprise a tissue contact portion spanning the exposed surface and configured to provide fluid communication of pneumatic pressure from the manifold to the tissue site.
  • the cap may be coupled to the tissue contact portion and/or the manifold.
  • the tissue contact portion in some embodiments may comprise a plurality of apertures configured to allow fluid communication between the manifold and the tissue site. In some embodiments, the tissue contact portion may comprise the exposed surface of the manifold. In other embodiments, the tissue contact portion may comprise an end cap having a plurality of apertures configured to allow fluid communication between the manifold and the tissue site. In some embodiments, the end cap may comprise or consist essentially of a gel layer.
  • the tissue contact portion may comprise a gel layer having a plurality of apertures; the gel layer may be configured to removably attach the massage therapy pad to the tissue site and/or to seal the massage therapy pad to the tissue site; and the plurality of apertures may be configured to allow fluid communication between the manifold and the tissue site.
  • Some tissue contact portion embodiments may further comprise a separate end cap formed of gas impermeable material and located between the separate gel layer and the manifold, with the end cap comprising a plurality of apertures and the apertures in the gel layer aligning with the apertures in the end cap.
  • the tissue contact portion may comprise a hydrophobic layer that is gas permeable and liquid impermeable.
  • the tissue contact portion may comprise a disposable absorption layer.
  • the manifold of some embodiments may comprise a porous material.
  • the manifold may comprise a porous (e.g. open cell) foam and/or a porous fabric material.
  • the manifold may be configured to support the cap to prevent collapse upon application of negative pneumatic pressure.
  • the cap may be configured to be self-supporting, so as to not collapse upon application of negative pneumatic pressure.
  • a massage therapy pad comprising a manifold comprising a plurality of cells formed by cell walls; a cap enclosing the manifold on all but an exposed surface of the manifold; a tissue contact portion spanning the exposed surface and configured to provide fluid communication of pneumatic pressure from the manifold to the tissue site (e.g. through apertures); and a port configured for communication of pneumatic pressure into the cap.
  • the cell walls may form sealed cells, with no fluid communication between the plurality of cells through the cell walls.
  • each of the plurality of cells may be configured to be independently pressurized.
  • Some embodiments may further comprise a pneumatic connection interface configured to supply pneumatic pressure independently to each of the plurality of cells.
  • Some embodiments may further comprise a multi-lumen conduit having a plurality of lumens for independent application of pneumatic pressure to each of the plurality of cells (e.g. through the pneumatic connection interface).
  • each of the plurality of cells may comprise two or more of the cell walls, along with manifold material (e.g. porous material) between the cell walls.
  • manifold material e.g. porous material
  • each of the plurality of cells may comprise two or more of the cell walls, along with open space between the cell walls.
  • Massage device embodiments are also disclosed, and exemplary embodiments may comprise a pneumatic pressure source; and a massage therapy pad fluidly coupled to the pneumatic pressure source.
  • the massage therapy pad for such massage device embodiments may be any disclosed herein.
  • the massage therapy pad may comprises a manifold; a cap enclosing the manifold on all but an exposed surface of the manifold; and a port configured for communication of pneumatic pressure into the massage therapy pad.
  • the massage therapy pad may further comprise a tissue contact portion spanning the exposed surface; the tissue contact portion may comprise a gel layer having a plurality of apertures; the gel layer may be configured to removably attach the massage therapy pad to the tissue site and/or to seal the massage therapy pad to the tissue site; and the plurality of apertures may be configured to allow fluid communication between the manifold and the tissue site.
  • the massage therapy pad may further comprises a tissue contact portion spanning the exposed surface and configured to provide fluid communication of pneumatic pressure from the manifold to the tissue site; and the tissue contact portion may comprise a hydrophobic layer that is gas permeable and liquid impermeable.
  • the manifold may comprise a plurality of cells formed by cell walls; the cell walls may form sealed cells, with no fluid communication between the plurality of cells through the cell walls; each of the plurality of cells may be configured to be independently pressurized; and/or the massage therapy pad may further comprise a tissue contact portion spanning the exposed surface and configured to provide fluid communication of pneumatic pressure from the manifold to the tissue site.
  • the pneumatic pressure source may be configured to provide positive pressure. In some embodiments, the pneumatic pressure source may be configured to provide negative pressure. In some embodiments, the pneumatic pressure source may be configured to provide both positive and negative pressure. Some device embodiments may further comprise a controller configured to control delivery of pneumatic pressure from the pneumatic pressure source to the massage therapy pad. For example, the controller may cycle between negative pressure and positive pressure in some embodiments. In some embodiments, the controller may vary pneumatic pressure based on one or more patterns. For example, the one or more patterns may each vary pneumatic pressure with frequency between 30 seconds and 1 minute, and/or the amount of negative pressure provided by the pneumatic pressure source may be approximately 125 mmHg negative pressure or less.
  • System embodiments may be configured to apply pneumatic pressure to a plurality of tissue sites on a user, with exemplary embodiments comprising a pneumatic pressure source; and a plurality of massage therapy pads each fluidly coupled to the pneumatic pressure source.
  • Each of the massage therapy pads may be any embodiments disclosed herein.
  • each of the plurality of massage therapy pads may comprise a manifold; and a cap enclosing the manifold on all but an exposed surface of the manifold.
  • each of the plurality of massage therapy pads may further comprise a tissue contact portion spanning the exposed surface; the tissue contact portion may comprises a gel layer having a plurality of apertures; the gel layer may be configured to removably attach and/or seal to the tissue site; and the plurality of apertures may be configured to allow fluid communication between the manifold and the tissue site.
  • each of the plurality of massage therapy pads may further comprise a tissue contact portion spanning the exposed surface and configured to provide fluid communication of pneumatic pressure from the manifold to the tissue site; and the tissue contact portion may comprise a hydrophobic layer that is gas permeable and liquid impermeable.
  • the manifold for each of the plurality of massage therapy pads may comprise a plurality of cells formed by cell walls; the cell walls may form sealed cells, with no fluid communication between the plurality of cells through the cell walls; and each of the plurality of cells may be configured to be independently pressurized.
  • each of the plurality of massage therapy pads may receive pneumatic pressure from the pneumatic pressure source independently of the other massage therapy pads.
  • the pneumatic pressure source of some embodiments may be configured to provide negative pressure to the plurality of massage therapy pads, positive pressure to the plurality of massage therapy pads, and/or both positive and negative pressure to the plurality of massage therapy pads.
  • Some system embodiments may further comprise a controller configured to control delivery of pneumatic pressure from the pneumatic pressure source to the plurality of massage therapy pads.
  • the controller may cycle between negative pressure and positive pressure.
  • the controller may vary pneumatic pressure to each of the plurality of massage therapy pads based on one or more patterns.
  • Methods of massaging a tissue site are also described herein, and exemplary embodiments may comprise: placing the massage therapy pad on a tissue site with intact skin; and applying pneumatic pressure to the tissue site via the massage therapy pad. Applying pneumatic pressure may massage the tissue site, for example due to direct application of pneumatic pressure to the tissue site.
  • placing the massage therapy pad may comprise removably attaching the massage therapy pad to the tissue site.
  • the massage therapy pad may comprise a gel layer, and removably attaching the massage therapy pad may comprise pressing the gel layer into contact with the tissue site.
  • applying pneumatic pressure may comprise applying negative pressure of no more than 125 mmHg negative pressure to the tissue site.
  • applying pneumatic pressure may comprise applying positive pressure to the tissue site.
  • applying pneumatic pressure may comprise cyclically applying negative and positive pressure to the tissue site.
  • applying pneumatic pressure may further comprise varying the pneumatic pressure based on one or more patterns.
  • each of the one or more patterns may vary pneumatic pressure to the massage therapy pad with a frequency between 30 seconds and 1 minute.
  • Some method embodiments may further comprise removing the massage therapy pad from the tissue site; and refreshing an adhesive characteristic of the gel layer.
  • refreshing the adhesive characteristic of the gel layer may comprise cleaning the gel layer.
  • Some embodiments may further comprise reattaching the massage therapy pad to the user, and reapplying pneumatic pressure via the massage therapy pad.
  • the massage therapy pad may comprise a tissue contact portion that is gas permeable and liquid impermeable, so that liquid is not drawn into the massage therapy pad from the tissue site upon application of pneumatic pressure.
  • Some method embodiments may use a plurality of massage therapy pads, for example applying pneumatic pressure simultaneously at a plurality of tissue sites via the plurality of massage therapy pads.
  • pneumatic pressure may be applied independently to each of the plurality of massage therapy pads.
  • two or more of the plurality of massage therapy pads may simultaneously massage the user with different patterns of direct application of pneumatic pressure.
  • Some method embodiments may further comprise simultaneously releasing pneumatic pressure for all of the plurality of massage therapy pads.
  • FIG. 1 is a functional block diagram of an example embodiment of a massage therapy system that can provide pneumatic pressure massage in accordance with this specification;
  • FIG. 2 is another functional block diagram illustrating an embodiment of a massage therapy system with a plurality of massage therapy pads, configured to deliver pneumatic pressure massage to a plurality of tissue sites;
  • Figure 3 is a top plan view of an exemplary massage therapy pad on an exemplary tissue site
  • Figure 4 is a cross-sectional view of the massage therapy pad of Figure 3;
  • FIG. 5 is a bottom plan view of the massage therapy pad of Figure 3.
  • Figure 6 is a cross-sectional view of another exemplary massage therapy pad
  • Figure 7 is a cross-sectional view of yet another exemplary massage therapy pad
  • Figure 8 is a cross-sectional view of still another exemplary massage therapy pad
  • Figure 9 is a cross-sectional view of yet another exemplary massage therapy pad
  • Figure 10 is a schematic bottom plan view of still another exemplary massage therapy pad
  • Figure 11 is an isometric view of an exemplary pneumatic connection interface with multi-lumen tube which may be used with the massage therapy pad embodiment of Figure 10;
  • Figure 12 is an isometric view of an exemplary pneumatic-pressure source embodiment with integral controller
  • Figure 13 is an isometric view of yet another exemplary pneumatic -pressure source embodiment with integral controller
  • Figures 14 - 20 are each schematic charts illustrating exemplary pneumatic pressure patterns for massage
  • Figure 21 is a schematic view of an exemplary massage therapy device.
  • Figure 22 is a schematic view of an exemplary massage therapy system.
  • FIG. 1 is a simplified functional block diagram of an example embodiment of a massage therapy system 100 that can provide pneumatic pressure massage therapy in accordance with this specification.
  • the massage therapy system 100 may include a source or supply of pneumatic pressure, such as a pneumatic-pressure source 105, and a massage therapy pad 110, for example.
  • the massage therapy system 100 may also include a regulator or controller, such as a controller 115.
  • the controller 115 may optionally be integral to (e.g. housed within and/or attached to) the pneumatic-pressure source 105.
  • the massage therapy system 100 may include sensors to measure operating parameters and provide feedback signals to the controller 115 indicative ofthe operating parameters.
  • the therapy system 100 may include a first sensor 120 and a second sensor 125 coupled to the controller 115.
  • the pneumatic-pressure source 105 may be fluidly coupled to (e.g. in fluid communication with) the massage therapy pad 110.
  • the controller 115 may be electrically coupled to the pneumatic -pressure source 105.
  • the pneumatic-pressure source 105 may provide pneumatic pressure to the massage therapy pad 110 for massage.
  • Some components of the massage therapy system 100 may be housed within or used in conjunction with other components, such as sensors, processing units, alarm indicators, memory, databases, software, display devices, or user interfaces that further facilitate therapy.
  • the pneumatic -pressure source 105 may be combined with the controller 115 and/or other components into a therapy unit.
  • components of the massage therapy system 100 may be coupled directly or indirectly. Coupling may include fluid, mechanical, thermal, electrical, or chemical coupling (such as a chemical bond), or some combination of coupling in some contexts.
  • the pneumatic- pressure source 105 may be electrically coupled to the controller 115.
  • the pneumatic-pressure source 105 may be fluidly coupled to one or more distribution components, such as the massage therapy pad 110, which provide a fluid path to a tissue site .
  • components may also be coupled by virtue of physical proximity, being integral to a single structure, or being formed from the same piece of material.
  • the controller 115 and pneumatic-pressure source 105 may be joined together in some embodiments.
  • a distribution component is preferably detachable, and may be disposable, reusable, or recyclable.
  • the massage therapy pad 110 may be illustrative of a distribution component.
  • a fluid conductor for example fluidly coupling the pneumatic-pressure source 105 to the massage therapy pad 110, is another illustrative example of a distribution component.
  • a tube is an elongated, cylindrical structure with some flexibility, but the geometry and rigidity may vary.
  • some fluid conductors may be molded into or otherwise integrally combined with other components.
  • Distribution components may also include or comprise interfaces or fluid ports to facilitate coupling and de-coupling other components, including sensors and data communication devices.
  • a pneumatic-pressure supply such as the pneumatic-pressure source 105, may be one or more reservoirs of air at a positive and/or negative pressure, or may be a manual or electrically- powered device, such as a vacuum pump, a suction pump, a wall suction port available at many healthcare facilities, or a micro-pump, for example.
  • the pneumatic-pressure source 105 may be a negative-pressure source.
  • the pneumatic -pressure source 105 may be a positive pressure source.
  • the pneumatic-pressure source 105 may be configured to provide both positive and negative pressure.
  • “Positive pressure” generally refers to a pressure greater than a local ambient pressure, such as the ambient pressure in a local environment external to a sealed therapeutic environment. “Negative pressure” generally refers to a pressure less than a local ambient pressure, such as the ambient pressure in a local environment external to a sealed therapeutic environment. In many cases, the local ambient pressure may also be the atmospheric pressure at which a tissue site is located. Alternatively, the pressure may be less than a hydrostatic pressure associated with tissue at the tissue site. Unless otherwise indicated, values of pressure stated herein are gauge pressures. References to increases in negative pressure typically refer to a decrease in absolute pressure, while decreases in negative pressure typically refer to an increase in absolute pressure.
  • the pressure is generally a low vacuum, also commonly referred to as a rough vacuum, between -5 mm Hg (-667 Pa) and -500 mm Hg (-66.7 kPa).
  • Common therapeutic ranges may be between -50 mm Hg (-9.9 kPa) and -300 mm Hg (-39.9 kPa).
  • a controller such as the controller 115, may be a microprocessor or computer programmed to operate one or more components of the massage therapy system 100, such as the pneumatic -pressure source 105.
  • the controller 115 may be a microcontroller, which generally comprises an integrated circuit containing a processor core and a memory programmed to directly or indirectly control one or more operating parameters of the massage therapy system 100. Operating parameters may include the power applied to the pneumatic -pressure source 105, the pressure generated by the pneumatic-pressure source 105, and/or the pressure distributed to the massage therapy pad 110, for example.
  • the controller 115 is also preferably configured to receive one or more input signals, such as a feedback signal, and programmed to modify one or more operating parameters based on the input signals.
  • Sensors such as the first sensor 120 and the second sensor 125, are generally known in the art as any apparatus operable to detect or measure a physical phenomenon or property, and generally provide a signal indicative of the phenomenon or property that is detected or measured.
  • the first sensor 120 and the second sensor 125 may be configured to measure one or more operating parameters of the massage therapy system 100.
  • the first sensor 120 may be a transducer configured to measure pressure in a pneumatic pathway and convert the measurement to a signal indicative of the pressure measured.
  • the first sensor 120 may be a piezo-resistive strain gauge.
  • the second sensor 125 may optionally measure operating parameters of the pneumatic-pressure source 105, such as the voltage or current, in some embodiments.
  • the signals from the first sensor 120 and the second sensor 125 are suitable as an input signal to the controller 115, but some signal conditioning may be appropriate in some embodiments.
  • the signal may need to be fdtered or amplified before it can be processed by the controller 115.
  • the signal is an electrical signal, but may be represented in other forms, such as an optical signal.
  • the fluid mechanics of using a pneumatic-pressure source to alter pressure in another component or location, such as within a sealed therapeutic environment, can be mathematically complex.
  • the basic principles of fluid mechanics applicable to pneumatic -pressure therapy are generally well-known to those skilled in the art, and the process of altering pressure may be described illustratively herein as “delivering,” “distributing,” or “generating” pneumatic pressure, for example.
  • FIG. 2 is a simplified functional block diagram of another example embodiment of a massage therapy system 100 that can provide pneumatic -pressure massage therapy in accordance with this specification. While Figure 2 may share many similarities to Figure 1, it further illustrates that some exemplary systems may comprise a plurality of massage therapy pads 110.
  • a single pneumatic-pressure source 105 may deliver pneumatic pressure to the plurality of massage therapy pads 110.
  • the controller 115 may direct the pneumatic-pressure source 105 to deliver pneumatic pressure to each of the plurality of massage therapy pads 110.
  • the pneumatic -pressure source 105 can simultaneously deliver different levels and/or patterns of pneumatic pressure to each of the plurality of massage therapy pads 110 and/or can independently direct pneumatic pressure to each of the massage therapy pads 110.
  • FIG 3 is a top plan view of an exemplary massage therapy pad 110 of Figure 1 in place on a tissue site 305 and configured to apply pneumatic pressure to an intact (e.g. non-wound) tissue site, illustrating additional details that may be associated with some embodiments.
  • the massage therapy pad 110 may include a port 310.
  • the port 310 may be configured to allow for fluid communication of pneumatic pressure (e.g. from a pneumatic- pressure source fluidly coupled to the massage therapy pad 110 via the port) into the massage therapy pad 110.
  • FIG 4 is a cross-section view of the massage therapy pad 110 of Figure 3, illustrating additional details that may be associated with some embodiments.
  • the massage therapy pad 110 may comprise a manifold 405; a cap 410 enclosing the manifold 405 on all but an exposed surface 415 of the manifold 405 (e.g. the tissue-site-facing surface of the manifold); and a port 310 configured for communication of pneumatic pressure into the cap 410 and/or into fluid communication with the manifold 405 (e.g. allowing fluid communication between the pneumatic- pressure source and the massage therapy pad).
  • the massage therapy pad 110 may further comprise a tissue contact portion, which may be an end cap 420 in some embodiments, spanning the exposed surface 415 and/or configured to allow fluid communication of pneumatic pressure from the manifold 405 to the tissue site 305.
  • the tissue contact portion may comprise a plurality of apertures 425 (e.g. through-holes) configured to allow fluid communication between the manifold 405 and the tissue site 305.
  • the apertures 425 may be configured (e.g. sized and/or spaced) to not substantially draw skin from the tissue site into an interior volume of the cap 410 and/or into the apertures 425.
  • the cap 410 may be coupled to the manifold 405 and/or tissue contact portion (e.g. the end cap 420).
  • the cap 410 may be welded to the tissue contact portion (e.g. the end cap 420).
  • the coupling between the cap 410 and the tissue contact portion may be sufficiently rigid as to substantially preclude movement (e.g. vibration) of the tissue contact portion with respect to the cap 410.
  • the tissue contact portion itself may be sufficiently rigid so as to not substantially vibrate across its surface.
  • the port 310 may be located on the cap 410 (e.g. on an upper portion, away from the tissue contact portion).
  • the tissue contact portion comprises or consists essentially of the end cap 420.
  • the end cap 420 may span the exposed surface 415 (e.g. sealingly attaching to the lower edge of the cap 410, such that the manifold 405 may be completely enclosed between the cap 410 and the end cap 420, and the end cap 420 may be located on the bottom and/or the tissue-site-facing side of the massage therapy pad 110), and comprises the plurality of apertures 425.
  • the end cap 420 may comprise or consist essentially of a gas impermeable (e.g. non-porous) material (e.g.
  • the end cap 420 and/or tissue contact portion may comprise or consist essentially of a gel layer having the plurality of apertures 425.
  • the gel layer may be configured to removably attach the massage therapy pad to the tissue site and/or to seal the tissue contact portion to the tissue site.
  • Some embodiments of the gel layer may also be configured for reuse (e.g. allowing the massage therapy pad to be attached, removed, and then reattached, for example multiple times).
  • the gel layer may be configured so that its adhesive characteristic may be refreshed by cleaning (e.g. with water and/or soap) between uses.
  • cleaning the gel layer may restore the adhesive characteristic of the gel layer to substantially its initial value. In other embodiments, cleaning the gel layer may at least restore the adhesive characteristic to a sufficient value to allow the massage therapy pad 110 to be re-adhered to the user (e.g. for multiple uses).
  • the massage therapy pad 110 may be low-profile (e.g. 1/16 - 1/8 inch thick).
  • Some embodiments of the massage therapy pad may further comprise a release liner or reusable cover, which may be configured to protect the gel layer from contamination when the massage therapy pad 110 is not in use and to be removed to expose the gel layer for use. The release liner or reusable cover may be configured to protect the adhesive characteristic of the gel layer during storage (e.g. to not substantially impair the adhesive characteristic upon removal) and/or to be easily removable to expose the gel layer for use.
  • the massage therapy pad 110 does not comprise a vibrating element.
  • none of the elements of the massage therapy pad 110 may be configured to substantially vibrate with respect to each other or to substantially vibrate themselves.
  • the tissue contact portion e.g. end cap 420
  • the tissue contact portion also may not vibrate substantially across its surface (e.g. it may be sufficiently rigid so as to resist vibration).
  • applied pneumatic pressure may not substantially vibrate or otherwise induce movement of the tissue contact portion.
  • the applied pneumatic pressure may flow through the manifold 405 and the tissue contact portion (e.g. via the apertures 425) outward to the tissue site 305 to directly massage the tissue site 305 by pneumatic pressure directly acting on the tissue site (e.g. without any intervening element/component between the supplied pneumatic pressure and the tissue site).
  • the air pressure may contact the tissue site, for example with suction effect, in some embodiments.
  • the tissue site 305 itself, or portions thereof, may actually vibrate due to the direct application of pneumatic pressure from the massage therapy pad 110.
  • the pneumatic pressure may press the tissue site 305 and/or cause an inward deflection of the tissue site (e.g.
  • vibrations upon application of positive pressure to the tissue site), and may draw or pull the tissue site and/or cause outward deflection (e.g. upon application of negative pressure to the tissue site), and such movement may result in vibration of the tissue site 305 (e.g. based on the pattern of pressure variance).
  • variations in the negative and/or positive pneumatic pressure may induce vibrations, deformation, and/or movement at the tissue site 305.
  • vibrations may only be present and/or induced at the tissue site 305, and not within the massage therapy pad 110 itself.
  • the manifold 405 may provide a means for distributing pneumatic (e.g. air) pressure throughout the massage therapy pad 110 (e .g . within the cap 410) and/or from the port 310 to the tissue contact portion (e.g. the end cap 420).
  • the manifold 405 may be adapted to receive pneumatic pressure from a pneumatic -pressure source (e.g. through the port 310) and distribute the pneumatic pressure through multiple apertures, pores, flow channels, and/or pathways across the massage therapy pad 110, which may have the effect of drawing a vacuum (e.g. applying negative pneumatic pressure) across the tissue site 305 and/or applying positive pneumatic air pressure across the tissue site 305.
  • the manifold 405 may comprise or consist essentially of a material that does not significantly restrict distribution of pneumatic pressure from the port 310 to the tissue site 305 and/or throughout an inner cavity/space within the cap 410.
  • the massage therapy pad 110 e.g. with manifold 405 within the cap 410) may be configured so that there is negligible pressure drop from port 310 to tissue contact portion.
  • the manifold 405 may comprise a porous material.
  • the manifold 405 may comprise a porous (e.g. open cell and/or reticulated) foam in some embodiments, while other embodiments of the manifold 405 may comprise a porous fabric.
  • the pathways of the manifold 405 may be interconnected to improve distribution of pneumatic pressure.
  • the manifold 405 may comprise or consist essentially of a porous material having interconnected fluid pathways (e.g. with good permeability of fluids while under pressure).
  • a porous material having interconnected fluid pathways (e.g. with good permeability of fluids while under pressure).
  • open-cell foam, porous tissue collections, and other porous material such as gauze or felted mat generally include pores, edges, and/or walls adapted to form interconnected fluid channels.
  • suitable materials may include a 3D textile (Baltex, Muller, Heathcoates), non-woven (Libeltex, Freudenberg), a 3D polymeric structure (molded polymers, embossed and formed fdms, and fusion bonded fdms - such as Supracore), and mesh, for example .
  • Liquids, gels, and other foams may also include or be cured to include apertures and fluid pathways.
  • the manifold 405 may additionally or alternatively comprise projections that form interconnected fluid pathways.
  • the manifold 405 may be molded to provide surface projections that define interconnected fluid pathways. Any or all of the surfaces of the manifold 405 may have an uneven, coarse, or jagged profile.
  • the manifold 405 may comprise or consist essentially of reticulated foam having pore sizes and free volume that may vary according to needs of the massage therapy.
  • reticulated foam having a free volume of at least 90% may be suitable for many therapy applications, and foam having an average pore size in a range of 400-600 microns may be particularly suitable for some types of massage therapy.
  • the tensile strength of the manifold 405 may also vary according to needs of the massage therapy.
  • the 25% compression load deflection of the manifold 405 may be at least 0.35 pounds per square inch, in some embodiments, and the 65% compression load deflection may be at least 0.43 pounds per square inch.
  • the tensile strength of the manifold 405 may be at least 10 pounds per square inch.
  • the manifold 405 may, in some embodiments, have a tear strength of at least 2.5 pounds per inch.
  • the manifold 405 may be foam comprised of polyols such as polyester or polyether, isocyanate such as toluene diisocyanate, and polymerization modifiers such as amines and tin compounds.
  • the manifold 405 may be a reticulated polyurethane foam such as used in GRANUFOAMTM dressing or V.A.C. VERAFLOTM dressing, both available from KCI of San Antonio, Texas.
  • the manifold 405 may generally have a first planar surface and a second planar surface opposite the first planar surface.
  • the thickness of the manifold 405 between the first planar surface and the second planar surface may also vary according to needs of the massage therapy. For example, the thickness of the manifold 405 may be decreased to relieve stress on other layers and to reduce tension on peripheral tissue.
  • the thickness of the manifold 405 can also affect the conformability of the manifold 405 and/or massage therapy pad 110. In some embodiments, a thickness in a range of about 5 millimeters to 10 millimeters may be suitable. In some embodiments, a thickness in a range of about 1/16 to 1/8 inch may be suitable.
  • the manifold 405 may be configured to support the cap to prevent collapse under applied negative pneumatic pressure (e.g. maintaining open pathways for distribution of the pneumatic pressure) and/or to maintain an open treatment space within the cap 410.
  • the cap 410 may comprise or consist essentially of a material that can provide a seal adequate to maintain the pneumatic pressure at the tissue site for a given pneumatic-pressure source.
  • the cap 410 may provide adequate seal and/or be sufficiently gas impermeable to substantially prevent pneumatic (e.g. air) pressure within the cap 410 from escaping through the cap material, which may provide an effective fluid seal between two components or two environments (such as between a pneumatic pressurized environment within the massage therapy pad 110 and a local external environment).
  • the cap 410 may comprise or consist of, for example, an elastomeric film or membrane that can provide a seal adequate to maintain pneumatic (e.g. air) pressure at a tissue site for a given pneumatic-pressure source.
  • the cap 410 may have a high moisture-vapor transmission rate (MVTR) in some applications.
  • MVTR moisture-vapor transmission rate
  • the MVTR may be at least 250 grams per square meter per twenty-four hours in some embodiments, measured using an upright cup technique according to ASTM E96/E96M Upright Cup Method at 38°C and 10% relative humidity (RH).
  • RH relative humidity
  • an MVTR up to 5,000 grams per square meter per twenty-four hours may provide effective breathability and mechanical properties.
  • the cap 410 may be a polymer drape material, such as a polyurethane film, that is permeable to water vapor but substantially impermeable to liquid and/or air.
  • a polymer drape material such as a polyurethane film
  • Such drapes typically have a thickness in the range of 25-50 microns.
  • the permeability generally should be low enough that a desired pneumatic pressure may be maintained.
  • the cap 410 may comprise one or more of the following materials: polyurethane (PU), such as hydrophilic polyurethane; cellulosics; hydrophilic polyamides; polyvinyl alcohol; polyvinyl pyrrolidone; hydrophilic acrylics; silicones, such as hydrophilic silicone elastomers; natural rubbers; polyisoprene; styrene butadiene rubber; chloroprene rubber; polybutadiene; nitrile rubber; butyl rubber; ethylene propylene rubber; ethylene propylene diene monomer; chlorosulfonated polyethylene; polysulfide rubber; ethylene vinyl acetate (EVA); co-polyester; and polyether block polymide copolymers.
  • PU polyurethane
  • PU polyurethane
  • hydrophilic polyurethane such as hydrophilic polyurethane
  • cellulosics such as cellulosics; hydrophilic polyamides; polyviny
  • the cap 410 may comprise INSPIRE 2301 having an MVTR (upright cup technique) of 2600 g/m2/24 hours and a thickness of about 30 microns.
  • the cap 410 may be configured to be self-supporting (e.g. to not collapse under applied negative pneumatic pressure based on its own structure, without having to rely on support from the manifold to prevent substantial collapse).
  • the cap 410 may be rigid or semi rigid.
  • the cap 410 may comprise or consist essentially of a rigid or semi-rigid silicone material.
  • the cap 410 may further comprise one or more support structures (such as ribs, which might be molded-in in some embodiments), which may increase rigidity and/or allow the cap 410 to be self-supporting (e .g . so that the cap 410 will not collapse under applied negative pneumatic pressure).
  • the gel layer may comprise or consist essentially of a soft, pliable material, such as a tacky gel, suitable for providing a fluid and/or pneumatic seal with a tissue site 305, and may have a substantially flat surface.
  • the gel layer may be sufficiently tacky to hold the massage therapy pad 110 in position during usage, while also allowing the massage therapy pad 110 to be removed or re-positioned without trauma to the tissue site 305.
  • the gel layer may comprise, without limitation, a silicone gel, a soft silicone, hydrocolloid, hydrogel, polyurethane gel, polyolefin gel, hydrogenated styrenic copolymer gel, a foamed gel, a soft closed cell foam such as polyurethanes and polyolefins coated with an adhesive, polyurethane, polyolefin, hydrogenated styrenic copolymers, and/or a thermoplastic elastomer (TPE) gel.
  • the gel layer may include an adhesive surface on an underside and/or a patterned coating of acrylic.
  • the gel layer may comprise a low-tack adhesive layer instead of silicone.
  • the gel layer may have a thickness between about 200 microns (pm) and about 1000 microns (pm).
  • the gel layer may be about 1/32 inch thick.
  • the gel layer may be sufficiently thick to allow effective adhesion and/or sealing to an uneven tissue site.
  • the gel layer may have a low durometer.
  • the gel layer may have a hardness between about 5 Shore OO and about 80 Shore OO.
  • the gel layer may be comprised of hydrophobic or hydrophilic materials, in some embodiments. In some embodiments, the gel layer may be a hydrophobic-coated material.
  • the gel layer may be formed by coating a spaced material, such as, for example, woven, nonwoven, molded, or extruded mesh with a hydrophobic material.
  • the hydrophobic material for the coating may be a soft silicone, for example.
  • the gel layer and/or end cap 420 may include apertures 425.
  • the apertures 425 may be formed by cutting or by application of local RF or ultrasonic energy, for example, or by other suitable techniques for forming an opening.
  • the apertures 425 may have a uniform distribution pattern, or may be randomly distributed on the gel layer.
  • the apertures 425 in the gel layer (and/or other end cap 420) may have many shapes, including circles, squares, stars, ovals, polygons, slits, complex curves, rectilinear shapes, triangles, for example, or may have some combination of such shapes.
  • Each of the apertures 425 may have uniform or similar geometric properties.
  • each of the apertures 425 may be circular apertures, having substantially the same diameter.
  • the diameter of each of the apertures 425 may be between about 1 millimeter and about 50 millimeters. In other embodiments, the diameter of each of the apertures 425 may be between about 1 millimeter and about 20 millimeters.
  • geometric properties of the apertures 425 may vary.
  • the diameter of the apertures 425 may vary depending on the position of the apertures 425 in the gel layer and/or end cap 420.
  • the apertures 425 may be spaced substantially equidistant over the gel layer.
  • the plurality of apertures 425 may be substantially coextensive with the gel layer and/or end cap 420. Alternatively, the spacing of the apertures 425 may be irregular.
  • Figure 5 is a bottom plan view of the massage therapy pad 110 of Figure 3, illustrating additional details that may be associated with some embodiments.
  • Figure 5 illustrates an exemplary embodiment of the tissue contact portion (e.g. the end cap 420) with apertures 425.
  • the end cap 420 surface illustrated in Figure 5 may be configured to contact the tissue site.
  • the outer (e.g. lower) gel layer surface would be exposed to contact the tissue site when in use.
  • FIG. 6 is a cross-section view of an alternative massage therapy pad 110 embodiment, illustrating additional details that may be associated with some embodiments.
  • the tissue contact portion further comprises a separate end cap 420 (e.g. a separate support plate of gas impermeable material with a first set of apertures) and a separate gel layer 605 (e.g. with a second set of apertures), with the separate end cap 420 (e.g. support plate) located between the gel layer 605 and the manifold 405.
  • the gel layer 605 may form the outer lower surface (e.g. tissue-site-facing surface) of the massage therapy pad 110.
  • the gel layer 605 may be positioned as the exterior surface of the tissue contact portion (e.g.
  • the gel layer 605 may be similar to that described above (for example, comprising or consisting essentially of silicone gel and/or TPE gel in some embodiments).
  • the apertures 425 in the tissue contact portion may penetrate both the end cap 420 (e.g. support plate) and the gel layer 605.
  • the end cap 420 may comprises a first plurality of apertures (e.g. through-holes passing through the end cap/support plate), the gel layer 605 may comprise a second plurality of apertures (e.g.
  • each of the first plurality of apertures may align with one of the second plurality of apertures, so that together the first plurality of apertures in the end cap 420 and the second plurality of apertures in the gel layer 605 may form the plurality of apertures 425 in the tissue contact portion (e.g. passing through the entirety of the tissue contact portion, to allow fluid communication between the manifold 405 and the tissue site external to the massage therapy pad 110).
  • FIG. 7 is a cross-section view of an alternative massage therapy pad 110 embodiment, illustrating additional details that may be associated with some embodiments.
  • the massage therapy pad 110 of Figure 7 is similar to that shown in Figure 4, but further includes a layer, such as a hydrophobic layer 705, configured to substantially prevent entry of liquid into the manifold of the massage therapy pad 110.
  • the massage therapy pad 110 and/or the tissue contact portion of Figure 7 may be configured to not substantially draw fluid from the tissue site.
  • the tissue contact portion may comprises the hydrophobic layer 705.
  • the hydrophobic layer 705 may be located adjacent to the manifold 405 and/or between the manifold 405 and the end cap 420 (e.g.
  • the hydrophobic layer 705 may be gas permeable (e.g. allowing transmission of pneumatic pressure from the manifold 405 to the tissue site) and substantially impermeable to liquid (e.g. preventing entry of liquid into the manifold).
  • the hydrophobic layer 705 may comprise a hydrophobic membrane or filter.
  • the hydrophobic layer 705 may substantially span the exposed surface 415 of the manifold 405, while in other embodiments the hydrophobic layer may at least span the apertures 425.
  • the tissue contact portion may comprise an absorption layer (e.g.
  • Various massage therapy pad 110 embodiments may include such a hydrophobic layer 705 and/or absorption layer embodiment.
  • the contact angle of the hydrophobic layer 705 may be in a range of at least 90 degrees to about 120 degrees, or in a range of at least 120 degrees to 150 degrees.
  • Water contact angles can be measured using any standard apparatus. Although manual goniometers can be used to visually approximate contact angles, contact angle measuring instruments can often include an integrated system involving a level stage, liquid dropper such as a syringe, camera, and software designed to calculate contact angles more accurately and precisely, among other things.
  • Non-limiting examples of such integrated systems may include the FTA125, FTA200, FTA2000, and FTA4000 systems, all commercially available from First Ten Angstroms, Inc., of Portsmouth, VA, and the DTA25, DTA30, and DTA100 systems, all commercially available from Kruss GmbH of Hamburg, Germany.
  • water contact angles herein are measured using deionized and distilled water on a level sample surface for a sessile drop added from a height of no more than 5 cm in air at 20-25°C and 20-50% relative humidity. Contact angles reported herein represent averages of 5- 9 measured values, discarding both the highest and lowest measured values.
  • the hydrophobicity of the hydrophobic layer 705 may be further enhanced with a hydrophobic coating of other materials in some embodiments.
  • the hydrophobic layer 705 may comprise or consist essentially of a hydrophobic polymer, such as a polyethylene film.
  • a hydrophobic polymer such as a polyethylene film.
  • the simple and inert structure of polyethylene can provide a surface that interacts little, if any, with biological tissues and fluids, providing a surface that may encourage the free flow of fluids and low adherence, which can be particularly advantageous for many applications.
  • suitable polymeric films may include polyurethanes, acrylics, polyolefin (such as cyclic olefin copolymers), polyacetates, polyamides, polyesters, copolyesters, PEBAX block copolymers, thermoplastic elastomers, thermoplastic vulcanizates, polyethers, polyvinyl alcohols, polypropylene, polymethylpentene, polycarbonate, styreneics, silicones, fluoropolymers, and acetates.
  • a thickness between 20 microns and 100 microns may be suitable for many applications. Films may be clear, colored, or printed.
  • More polar films suitable for laminating to a polyethylene film include polyamide, co-polyesters, ionomers, and acrylics.
  • tie layers may be used, such as ethylene vinyl acetate, or modified polyurethanes.
  • An ethyl methyl acrylate (EMA) film may also have suitable hydrophobic and welding properties for some configurations.
  • FIG 8 is a cross-section view of an alternative massage therapy pad 110 embodiment, illustrating additional details that may be associated with some embodiments.
  • the embodiment of Figure 8 may be similar to the massage therapy pad 110 shown in Figure 4, but in some embodiments may not include an end cap.
  • the massage therapy pad 110 embodiment may further comprise an edge seal 805 configured to seal a perimeter of the exposed surface 415 and/orto removably attach the cap 410 to the tissue site.
  • the edge seal 805 in some embodiments may comprise a gel layer or ring located around the perimeter of the cap 410 (e.g. along the edge surface of the cap).
  • the edge seal 805 may comprise or consist essentially of materials similar to those described for the gel layer.
  • the tissue contact portion may comprise the exposed surface 415 of the manifold 405 and/or the edge seal 805.
  • the exposed surface 415 may be substantially even with the edge seal 805 (e.g. such that the exposed surface 415 may contact the tissue site when the massage therapy pad 110 is applied in place for use), while in other embodiments the edge seal 805 may extend outward past the exposed surface 415 (e.g. such that the exposed surface 415 may not contact the tissue site when the massage therapy pad 110 is applied in place for use).
  • FIG. 9 is a cross-section view of an alternative massage therapy pad 110 embodiment, illustrating additional details that may be associated with some embodiments.
  • the exemplary embodiment shown in Figure 9 may be similar to that shown in Figure 8, but in some embodiments may not include an edge seal.
  • the tissue contact portion may comprise or consist essentially of the exposed surface 415 of the manifold 405 in some embodiments.
  • negative pressure applied to the massage therapy pad 110 may form sufficient suction to create a seal between the cap 410 and the tissue site.
  • the exposed surface 415 of the manifold 405 may directly contact the tissue site and be in fluid communication with the tissue site (e.g. with the exposed surface 415 forming the tissue contact portion in some embodiments).
  • the massage therapy pad 110 may be held in contact with the tissue site manually, for example by a practitioner and/or the user, at least until pneumatic pressure suction is applied via the port 310.
  • FIG 10 is a schematic bottom plan view of an alternative massage therapy pad 110 embodiment, illustrating additional details that may be associated with some embodiments.
  • the manifold may comprise a plurality of cells 1005 (e.g. with each cell 1005 comprising cell walls 1010 configured to separate and seal the cells from each other).
  • One or more cell walls 1010 may form each of the sealed cells 1005, with no fluid communication between cells 1005 through the cell walls 1010. So in some embodiments, each of the cells 1005 may be sealed from the other cells (e.g. no fluid communication between cells).
  • each of the plurality of cells 1005 may comprise one or more ofthe apertures 425 (e.g. configured to allow fluid communication between the interior of the cells 1005 and the tissue site).
  • the cells 1005 may be substantially sealed except for these apertures 425.
  • the cells 1005 may form a honeycomb-like structure.
  • the cell walls 1010 may form a plurality of identical cells 1005, which may each be hexagonal in cross-section shape in some embodiments.
  • the plurality of cells 1005 may be formed by a lattice (e.g. grid) of cell walls 1010.
  • a lattice e.g. grid
  • only a single layer of cells 1005 may be formed in the cap, with the dividing cell walls 1010 extending between the inner surface of the cap and the exposed surface or end cap (e.g. tissue contact portion).
  • each cell 1005 may be bounded by the cap, the cell walls 1010, and the tissue contact portion.
  • each cell 1005 may be sealed except for the one or more apertures 425 in the tissue contact portion.
  • the cell walls 1010 may be rigid or semi-rigid. In other embodiments (for example, in which the cap is self-supporting), the cell walls 1010 may be flexible and/or non-supporting.
  • the support features for the cap e.g. configured to support the cap to prevent draw-down or collapse under any applied negative pressure
  • each cell 1005 may comprise open space between the cell walls 1010.
  • the cell structure formed by the walls may be empty (e.g. filled with air) with no other manifold material filling the cells 1005 between the cell wall 1010 structure.
  • each cell 1005 may comprise porous manifold material (e.g. porous foam or fabric, not shown) within the cell walls 1010 (e.g. substantially filling the cells).
  • each cell 1005 may be configured to be independently pressurized (e.g. configured so that pneumatic pressure may be applied independently to each cell).
  • Figure 11 is a schematic isometric view of an exemplary means for independently supplying pneumatic pressure to each of the plurality of cells of the massage therapy pad 110 of Figure 10, illustrating additional details that may be associated with some embodiments.
  • the means for independently supplying pneumatic pressure may comprise a pneumatic connection interface 1105, configured to supply pneumatic pressure independently to each cell.
  • the pneumatic connection interface 1105 may comprise a plurality of conduits 1110, with each conduit 1110 configured to independently provide fluid communication between one of the cells and the external environment (e.g. the pneumatic-pressure source outside the cap, via the port).
  • the pneumatic connection interface 1105 e.g. with branching independent conduits 1110) could be molded as part of the inner surface of the cap.
  • the means for independently supplying pneumatic pressure may also comprise a multi-lumen conduit 1115 having a plurality of lumens 1120 for independent application of pneumatic pressure to each of the cells.
  • each of the plurality of lumens 1120 may be in fluid communication with one of the cells via one of the conduits 1110 of the pneumatic connection interface 1105.
  • FIG 12 is a schematic isometric view of an exemplary pneumatic-pressure source 105 of Figure 1 for use with one or more of the massage therapy pads (e.g. supplying pneumatic pressure to the one or more massage therapy pads), illustrating additional details that may be associated with some embodiments.
  • the pneumatic-pressure source 105 may comprise or consist essentially of a pneumatic pump (e.g. an electric pump or a manual pump configured to provide pneumatic pressure, which might be positive or negative).
  • the pneumatic- pressure source 105 may be configured to provide negative pneumatic pressure.
  • the pneumatic-pressure source 105 may be configured to provide positive pneumatic pressure.
  • the pneumatic-pressure source 105 may be configured to provide both positive and negative pneumatic pressure.
  • the pneumatic-pressure source 105 may comprise a plurality of pressure outlets 1205, so that each of the plurality of massage therapy pads may independently receive pneumatic pressure from one of the pressure outlets 1205 of the pneumatic-pressure source 105 (e.g. each pressure outlet 1205 may be independently pressurized).
  • Figure 12 illustrates an embodiment with four pressure outlets 1205, allowing a single pneumatic-pressure source 105 to independently and/or simultaneously operate up to four massage therapy pads.
  • the pneumatic-pressure source 105 may be configured to simultaneously operate and provide pressure to all of the pressure outlets 1205 (e.g. all of the massage therapy pads coupled to the source).
  • the pneumatic-pressure source 105 may be configured to be able to provide maximum pressure (e.g. for the pressure pattem(s) applied to the pressure outlets) to all pressure outlets simultaneously.
  • the pneumatic-pressure source 105 may cycle and/or alternate pressure between two or more of the pressure outlets 1205 (e.g. not all pressure outlets 1205 may receive maximum pressure or any pressure at the same time).
  • the massage pressure patterns for two or more pressure outlets 1205 may be offset, so that the two or more pressure outlets 1205 do not all receive maximum pressure simultaneously (e.g. the maximum pressure may be applied to one pressure outlet while the minimum pressure may be applied to another pressure outlet, which may allow for a smaller overall pneumatic-pressure source 105 to provide the required pressure for all pressure outlets 1205).
  • the amount of negative pressure (e.g. the maximum negative pressure) provided to each pressure outlet 1205 by the pneumatic-pressure source 105 may be 125 mmHg negative pressure or less, 100 mmHg negative pressure or less, 80 mmHg negative pressure or less, 60 mmHg negative pressure or less, or 50 mmHg negative pressure or less.
  • absolute pneumatic pressure e.g. the absolute value of the pneumatic pressure
  • Some embodiments may further comprise a controller 115 configured to control delivery of pneumatic pressure from the pneumatic-pressure source 105 (e.g. from the pressure outlets 1205) to the one or more massage therapy pads.
  • the controller 115 may have one or more inputs 1210 (e.g. buttons) configured to allow selection of the intensity level (e.g. maximum intensity or absolute pneumatic pressure) for the pneumatic pressure and/or one or more inputs 1215 (e.g. buttons) configured to allow selection of the pattern of variation for the pneumatic pressure.
  • the controller 115 may comprise three buttons for intensity selection (e.g. high, medium, and low), and five buttons for patterns selection (e.g.
  • buttons may also cycle through to an off configuration for the pneumatic -pressure source (or there may be a separate input (e.g. button) to control power).
  • Some embodiments may also comprise one or more indicators (such as LED lights), for example configured to indicate the level, pattern, and/or power setting currently selected.
  • the embodiment of Figure 12 may also comprise a pressure release button 1220, configured to simultaneously release the pneumatic pressure from all pressure outlets 1205.
  • the controller 115 may be integral to the pneumatic -pressure source 105 (for example, with both located within a common housing).
  • Figure 13 is a schematic isometric view of an alternative exemplary pneumatic- pressure source 105, illustrating additional details that may be associated with some embodiments.
  • the pneumatic -pressure source 105 of Figure 13 is similar to that of Figure 12, but may consolidate some button functions.
  • a single button may allow selection of the intensity level and/or power (e.g. by allowing a user to cycle through various intensity levels available), and/or a single button may allow selection of the massage pattern and/or power (e.g. by allowing a user to cycle through various patterns available).
  • the controller 115 may only have two buttons.
  • the pneumatic pressure may be controlled to deliver a plurality of intermittent durations of pneumatic pressure to the tissue site (e.g. via the pressure outlets) to massage the tissue site.
  • the controller 115 may be configured to vary pneumatic pressure based on one or more pattern (e.g. intensity and/or wave profile). In some embodiments, the controller 115 may cycle between negative pressure and positive pressure. In some embodiments, the pattern may vary pneumatic pressure with a frequency period between 30 seconds and 1 minute. For embodiments with manifolds having a plurality of cells (such as shown in Figure 10), each cell may independently receive the same pneumatic pressure or the pneumatic pressure for each cell may be independently controlled (e.g. a pattern of rotation from one cell to another - for example clockwise).
  • Figure 14 is a schematic chart view of an exemplary pattern of pneumatic pressure variation for pneumatic massage therapy, illustrating additional details that may be associated with some embodiments.
  • the pattern shown in Figure 14 comprises a square wave with respect to absolute pneumatic pressure, having a wavelength ⁇ between peaks. Since the pattern is shown with respect to absolute pneumatic pressure, the actual pneumatic pressure peaks could all be positive, could all be negative, or could include both positive and negative pressure.
  • the exemplary patterns shown may be modified without changing the underlying principle.
  • the wave pattern in Figure 14 could have its minimum absolute pneumatic pressure set at zero in some embodiments.
  • Figure 15 is a schematic chart view of another exemplary pattern of pneumatic pressure variation for pneumatic massage therapy, illustrating additional details that may be associated with some embodiments.
  • the pattern shown in Figure 15 comprises a triangular wave with respect to absolute pneumatic pressure, which rises steadily to the peak (e.g. maximum value) and then drops quickly to its minimum value (e.g. valley) and has a wavelength between peaks.
  • the minimum pneumatic pressure value is zero. Since the pattern is shown with respect to absolute pneumatic pressure, the actual pneumatic pressure peaks could all be positive, could all be negative, or could include both positive and negative pressure.
  • Figure 16 is a schematic chart view of another exemplary pattern of pneumatic pressure variation for pneumatic massage therapy, illustrating additional details that may be associated with some embodiments.
  • the pattern shown in Figure 16 comprises a sinusoidal wave with respect to absolute pneumatic pressure, having a wavelength between peaks. Since the pattern is shown with respect to absolute pneumatic pressure, the actual pneumatic pressure peaks could all be positive, could all be negative, or could include both positive and negative pressure.
  • Figure 17 is a schematic chart view of another exemplary pattern of pneumatic pressure variation for pneumatic massage therapy, illustrating additional details that may be associated with some embodiments.
  • the pattern shown in Figure 17 comprises a wave with respect to absolute pneumatic pressure, having a wavelength between peaks.
  • the wave pattern may curve upward quickly, and then fall steadily. Since the pattern is shown with respect to absolute pneumatic pressure, the actual pneumatic pressure peaks could all be positive, could all be negative, or could include both positive and negative pressure.
  • Figure 18 is a schematic chart view of another exemplary pattern of pneumatic pressure variation for pneumatic massage therapy, illustrating additional details that may be associated with some embodiments.
  • the pattern shown in Figure 18 comprises two square wave patterns repeated cyclically over time with respect to absolute pneumatic pressure.
  • the first wave pattern having a wavelength 3d between peaks, may span a time period Tl
  • the second wave pattern having a wavelength 12 between peaks, may follow the first wave pattern in time and span time period T2, before the first wave pattern repeats. Since the patterns are shown with respect to absolute pneumatic pressure, the actual pneumatic pressure peaks could all be positive, could all be negative, or could include both positive and negative pressure.
  • Figure 19 is a schematic chart view of another exemplary pattern of pneumatic pressure variation for pneumatic massage therapy, illustrating additional details that may be associated with some embodiments.
  • the pattern shown in Figure 19 comprises a series of building waves (e.g. triangular waves, each building steadily to the peak, before quickly dropping to the minimum value, with each succeeding wave in the series having a larger peak).
  • the wave pattern may repeat every time period T3.
  • each time speriod T3 may comprise three waves, with the first wave being the smallest and the last wave being the largest. Since the patterns are shown with respect to absolute pneumatic pressure, the actual pneumatic pressure peaks could all be positive, could all be negative, or could include both positive and negative pressure.
  • Figure 20 is a schematic chart view of another exemplary pattern of pneumatic pressure variation for pneumatic massage therapy, illustrating additional details that may be associated with some embodiments.
  • the pattern shown in Figure 20 comprises a square wave pattern repeated cyclically over time with respect to pneumatic pressure.
  • the waves vary between positive and negative pneumatic pressure.
  • the wave pattern may vary from about 125 mmHg (or less) positive pressure to about -125 mmHg (or less) negative pressure (or alternatively from about 40 mmHg positive pressure to about -40 mmHg negative pressure).
  • the exemplary pneumatic pressure patterns illustrated in Figures 14-20 are merely illustrative, illustrating several possible features of some pattern embodiments.
  • FIG. 21 is a schematic view of an exemplary massage therapy device 2105 applied to an exemplary tissue site 305.
  • the massage therapy device 2105 of Figure 21 comprises a pneumatic pressure-source 105 fluidly coupled to a massage therapy pad 110, and configured to provide pneumatic pressure to the manifold of the massage therapy pad 110.
  • the pneumatic -pressure source 105 for Figure 21 may comprise any of those described herein.
  • the massage therapy pad 110 for Figure 21 may comprise any of those described herein.
  • the massage therapy pad 110 shown in Figure 21 is applied with its tissue contact portion contacting and in fluid communication with the tissue site.
  • pneumatic pressure from the pneumatic -pressure source 105 may be fluidly communicated to the manifold within the massage therapy pad 110, and then may be fluidly communicated from the manifold, through the tissue contact portion (e.g. apertures), to the tissue site.
  • the pneumatic pressure directly contacts the tissue site.
  • the massage therapy device 2105 may be wearable (e.g. by ambulatory user).
  • the pneumatic-pressure source 105 may be sufficiently small and lightweight to allow for convenient, comfortable wearing. This may be particularly true if the massage therapy pad 110 comprises a gel layer or other adhesive or retaining means for attachment to the tissue site.
  • FIG 22 is a schematic view of an exemplary pneumatic massage therapy system 100 applied to a plurality of distinct exemplary tissue sites on a user.
  • the system of Figure 22 comprises a single pneumatic pressure-source 105 fluidly coupled to a plurality of massage therapy pads 110, and configured to provide pneumatic pressure simultaneously and/or independently to each of the plurality of massage therapy pads 110.
  • the pneumatic-pressure source 105 for Figure 22 may comprise any of those described herein.
  • Each of the massage therapy pads 110 for Figure 22 may comprise any of those described herein.
  • the massage therapy pads 110 are applied with tissue contact portion contacting and in fluid communication with the corresponding tissue site.
  • the controller 125 may be integral to the pneumatic-pressure source 105 in this exemplary embodiment. In the embodiment of Figure 22, only a single pneumatic -pressure source 105 provides pressure to all of the massage therapy pads 110.
  • the pneumatic pressure massage device and system embodiments may be used to provide massage therapy to a user/patient.
  • the device and system embodiments may provide pneumatic pressure massage therapy by directly applying pneumatic pressure to one or more tissue sites (e.g. with the tissue sites experiencing pneumatic pressure via contact with a vacuum and/or pressurized air).
  • Some methods embodiments formassaging a tissue site using pneumatic pressure may comprise: placing the massage therapy pad on a tissue site (e.g. with intact skin); and applying pneumatic pressure to the tissue site via the massage therapy pad. Applying pneumatic pressure may massage the tissue site, for example due to direct application of pneumatic pressure to the tissue site (e.g. with positive and/or negative pneumatic pressure directly applied to and/or contacting the skin).
  • placing the massage therapy pad may comprise removably attaching the massage therapy pad to the tissue site.
  • the massage therapy pad may comprise a gel layer, and removably attaching the massage therapy pad may comprise pressing the gel layer into contact with the tissue site.
  • applying pneumatic pressure may comprise applying negative pressure, for example of no more than 125 mmHg negative pressure, to the tissue site.
  • applying pneumatic pressure may comprise applying positive pressure to the tissue site.
  • applying pneumatic pressure may comprise cyclically applying negative and positive pressure to the tissue site.
  • applying pneumatic pressure may further comprise varying the pneumatic pressure based on one or more patterns (e.g. using one or more of the patterns described above, or alternative patterns varying the pneumatic pressure, to induce massage).
  • each of the one or more patterns may vary pneumatic pressure to the massage therapy pad with a frequency period between 30 seconds and 1 minute.
  • Some method embodiments may further comprise removing the massage therapy pad from the tissue site; and refreshing an adhesive characteristic of the gel layer.
  • refreshing the adhesive characteristic of the gel layer may comprise cleaning the gel layer.
  • Some embodiments may further comprise reattaching the massage therapy pad to the user, and reapplying pneumatic pressure via the massage therapy pad.
  • the massage therapy pad may comprise a tissue contact portion that is gas permeable and liquid impermeable, so that liquid is not drawn into the massage therapy pad from the tissue site upon application of pneumatic pressure.
  • the configuration of the massage therapy pad may ensure that substantially no elements of the massage therapy pad vibrate substantially.
  • the tissue contact portion may not substantially vibrate in response to the pneumatic pressure patterns.
  • Some method embodiments may use a plurality of massage therapy pads, for example applying pneumatic pressure simultaneously at a plurality of tissue sites via the plurality of massage therapy pads.
  • pneumatic pressure may be applied independently to each of the plurality of massage therapy pads (e.g. using a single pneumatic-pressure source).
  • two or more of the plurality of massage therapy pads may simultaneously massage the user with different patterns of direct application of pneumatic pressure.
  • Some method embodiments may further comprise simultaneously releasing pneumatic pressure for all of the plurality of massage therapy pads.
  • massage may be automated (e.g. non-manual), and the automated massage process may eliminate or reduce the need for trained professional supervision.
  • pneumatic pressure By using direct application of pneumatic pressure to the tissue site(s) for the massage, safety concerns associated with electrical-type massagers, such as TENS units, may be eliminated.
  • the pneumatic massage device may be used near the user’s heart and/or neck and/or may be used by users/patients with heart problems.
  • pneumatic massage may help to open fluid pathways within the tissue site, in addition to massage effects due to physical movement and/or deformation of the tissue site by the pneumatic pressure.
  • Embodiments with a gel layer may allow for hands-free usage, which may be more convenient, may be more relaxing, and/or may allow for self-application (e.g. use without the need for an additional practitioner other than the patient, with the massage therapy pads capable of being self-placed on the body).
  • the gel layer may also allow for the adhesive characteristic to be refreshed, allowing the massage therapy pad to be re-used repeatedly.
  • Embodiments in which the manifold comprises a plurality of sealed, independent cells may also assist in maintaining pneumatic pressure massage, even over an uneven surface, since a lack of seal for one cell may not render the other cells inoperable.

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Abstract

Disclosed embodiments relate to pneumatic pressure massage devices that use pneumatic pressure application to one or more tissue sites to deliver a massage. In some embodiments, the massage device may comprise one or more massage therapy pads fluidly coupled to a pneumatic-pressure source. Each massage therapy pad may comprise a manifold within an outer cap, with the cap enclosing the manifold except for an exposed surface configured to be directed toward the tissue site. To provide a massage, pneumatic pressure may be directed from the pneumatic-pressure source, through the manifold, and to the tissue site, for example with pneumatic pressure directly acting upon the tissue site. Some massage therapy pad embodiments may further comprise a gel layer for removable attachment and sealing of the massage therapy pad to the tissue site.

Description

PNEUMATIC PRESSURE MASSAGE DEVICE
CROSS-REFERENCE TO REUATED APPUICATIONS
[0001] This application claims the benefit of priority to U.S. Provisional Application No. 62/892,842, filed on August 28, 2019, which is incorporated herein by reference in its entirety.
TECHNICAU FIEUD
[0002] The invention set forth in the appended claims relates generally to massage devices and systems and more particularly, but without limitation, to pneumatic massage devices that may induce massage through direct application of pneumatic pressure to a tissue site.
BACKGROUND
[0003] The therapeutic and/or relaxation benefits of massage have been well established over time. Many massage therapy approaches take place in a clinical setting, for example at a massage therapist’s office. In addition to traditional, hands-on massage therapy, in which a masseuse manually massages the body, non-manual massage techniques might be employed. A potential benefit of non- manual massage therapies may be the lack of need for the presence of a trained professional. This may help to open up massage options for non-clinical settings. For example, a transcutaneous electrical nerve stimulation (“TENS”) device may provide a non-manual massage approach by employing electrical stimulation to induce massage. Unfortunately, such TENS devices may have health and/or safety concerns, especially for placement near the heart or neck and/or for patients with a history of heart problems. Accordingly, improvements to non-manual massage therapy devices, systems, components, and processes may benefit providers and/or patients/users.
BRIEF SUMMARY
[0004] New and useful systems, apparatuses, and methods for massage are set forth in the appended claims. Illustrative embodiments are also provided to enable a person skilled in the art to make and use the claimed subject matter.
[0005] For example, embodiments may relate to massage devices using pneumatic pressure, which for example may be capable of providing massage therapy at various settings via one or more massage therapy pads attached to the skin. The pneumatic pressure may be directly applied to the skin or tissue site via the massage therapy pads, in order to provide the massage effect. For example, the one or more massage therapy pads may each comprise a porous manifold within a top cap. In some embodiments, the porous manifold for each pad may comprise porous foam, porous fabric, and/or a plurality of cells. The cap may be configured to seal the manifold (e.g. with respect to pneumatic air pressure) except for an exposed surface (e.g. which would typically be directed towards the tissue site). In some embodiments, a gel layer, configured to adhere and/or seal the pad to the skin, may span the exposed surface. The gel layer may be configured, for example with a plurality of apertures, to allow fluid communication of pneumatic pressure between the manifold (e.g. the interior of the cap) and the tissue site.
[0006] A pneumatic pressure source may be fluidly coupled to and/or may provide pneumatic pressure to the one or more massage therapy pads (e.g. into the cap and/or in fluid communication with the manifold). In some embodiments, a controller may apply or control the pneumatic pressure, which may be positive pressure, negative pressure, and/or both, at multiple intensity levels, multiple therapy patterns, and/or at multiple pads. For example, cell manifold embodiments may be configured to allow for independent pneumatic pressurization of each cell (e.g. with each cell sealed from the other cells). When pneumatic pressure is applied through the system, the pneumatic pressure may directly massage the tissue site/skin. For example, there may be substantially no vibration of the portion of the massage therapy pad contacting the skin. Rather than employing vibrating elements, the massage pad may massage the tissue site by direct contact of the pneumatic pressure on the tissue site, for example through the apertures in the gel layer.
[0007] More generally, some massage therapy pads may comprise a manifold; a cap enclosing the manifold on all but an exposed surface of the manifold; and a port configured for communication of pneumatic pressure into the cap. In some embodiments, the cap may be substantially gas impermeable. Some embodiments may further comprise an edge seal configured to seal a perimeter of the exposed surface and/or to removably attach the cap to the tissue site. For example, the edge seal may comprise a gel seal located around the perimeter. Other embodiments may further comprise a tissue contact portion spanning the exposed surface and configured to provide fluid communication of pneumatic pressure from the manifold to the tissue site. In some embodiments, the cap may be coupled to the tissue contact portion and/or the manifold. The tissue contact portion in some embodiments may comprise a plurality of apertures configured to allow fluid communication between the manifold and the tissue site. In some embodiments, the tissue contact portion may comprise the exposed surface of the manifold. In other embodiments, the tissue contact portion may comprise an end cap having a plurality of apertures configured to allow fluid communication between the manifold and the tissue site. In some embodiments, the end cap may comprise or consist essentially of a gel layer.
[0008] In some embodiments, the tissue contact portion may comprise a gel layer having a plurality of apertures; the gel layer may be configured to removably attach the massage therapy pad to the tissue site and/or to seal the massage therapy pad to the tissue site; and the plurality of apertures may be configured to allow fluid communication between the manifold and the tissue site. Some tissue contact portion embodiments may further comprise a separate end cap formed of gas impermeable material and located between the separate gel layer and the manifold, with the end cap comprising a plurality of apertures and the apertures in the gel layer aligning with the apertures in the end cap. In some embodiments, the tissue contact portion may comprise a hydrophobic layer that is gas permeable and liquid impermeable. In some embodiments, the tissue contact portion may comprise a disposable absorption layer.
[0009] The manifold of some embodiments may comprise a porous material. For example, the manifold may comprise a porous (e.g. open cell) foam and/or a porous fabric material. In some embodiments, the manifold may be configured to support the cap to prevent collapse upon application of negative pneumatic pressure. In other embodiments, the cap may be configured to be self-supporting, so as to not collapse upon application of negative pneumatic pressure.
[0010] Other example embodiments may relate to a massage therapy pad comprising a manifold comprising a plurality of cells formed by cell walls; a cap enclosing the manifold on all but an exposed surface of the manifold; a tissue contact portion spanning the exposed surface and configured to provide fluid communication of pneumatic pressure from the manifold to the tissue site (e.g. through apertures); and a port configured for communication of pneumatic pressure into the cap. The cell walls may form sealed cells, with no fluid communication between the plurality of cells through the cell walls. For example, each of the plurality of cells may be configured to be independently pressurized. Some embodiments may further comprise a pneumatic connection interface configured to supply pneumatic pressure independently to each of the plurality of cells. Some embodiments may further comprise a multi-lumen conduit having a plurality of lumens for independent application of pneumatic pressure to each of the plurality of cells (e.g. through the pneumatic connection interface). In some embodiments, each of the plurality of cells may comprise two or more of the cell walls, along with manifold material (e.g. porous material) between the cell walls. In other embodiments, each of the plurality of cells may comprise two or more of the cell walls, along with open space between the cell walls.
[0011] Massage device embodiments are also disclosed, and exemplary embodiments may comprise a pneumatic pressure source; and a massage therapy pad fluidly coupled to the pneumatic pressure source. The massage therapy pad for such massage device embodiments may be any disclosed herein. For example, the massage therapy pad may comprises a manifold; a cap enclosing the manifold on all but an exposed surface of the manifold; and a port configured for communication of pneumatic pressure into the massage therapy pad. In some exemplary embodiments, the massage therapy pad may further comprise a tissue contact portion spanning the exposed surface; the tissue contact portion may comprise a gel layer having a plurality of apertures; the gel layer may be configured to removably attach the massage therapy pad to the tissue site and/or to seal the massage therapy pad to the tissue site; and the plurality of apertures may be configured to allow fluid communication between the manifold and the tissue site. In other exemplary embodiments, the massage therapy pad may further comprises a tissue contact portion spanning the exposed surface and configured to provide fluid communication of pneumatic pressure from the manifold to the tissue site; and the tissue contact portion may comprise a hydrophobic layer that is gas permeable and liquid impermeable. In still other exemplary embodiments, the manifold may comprise a plurality of cells formed by cell walls; the cell walls may form sealed cells, with no fluid communication between the plurality of cells through the cell walls; each of the plurality of cells may be configured to be independently pressurized; and/or the massage therapy pad may further comprise a tissue contact portion spanning the exposed surface and configured to provide fluid communication of pneumatic pressure from the manifold to the tissue site.
[0012] In some embodiments, the pneumatic pressure source may be configured to provide positive pressure. In some embodiments, the pneumatic pressure source may be configured to provide negative pressure. In some embodiments, the pneumatic pressure source may be configured to provide both positive and negative pressure. Some device embodiments may further comprise a controller configured to control delivery of pneumatic pressure from the pneumatic pressure source to the massage therapy pad. For example, the controller may cycle between negative pressure and positive pressure in some embodiments. In some embodiments, the controller may vary pneumatic pressure based on one or more patterns. For example, the one or more patterns may each vary pneumatic pressure with frequency between 30 seconds and 1 minute, and/or the amount of negative pressure provided by the pneumatic pressure source may be approximately 125 mmHg negative pressure or less.
[0013] System embodiments may be configured to apply pneumatic pressure to a plurality of tissue sites on a user, with exemplary embodiments comprising a pneumatic pressure source; and a plurality of massage therapy pads each fluidly coupled to the pneumatic pressure source. Each of the massage therapy pads may be any embodiments disclosed herein. For example, each of the plurality of massage therapy pads may comprise a manifold; and a cap enclosing the manifold on all but an exposed surface of the manifold. In some exemplary embodiments, each of the plurality of massage therapy pads may further comprise a tissue contact portion spanning the exposed surface; the tissue contact portion may comprises a gel layer having a plurality of apertures; the gel layer may be configured to removably attach and/or seal to the tissue site; and the plurality of apertures may be configured to allow fluid communication between the manifold and the tissue site. In other exemplary embodiments, each of the plurality of massage therapy pads may further comprise a tissue contact portion spanning the exposed surface and configured to provide fluid communication of pneumatic pressure from the manifold to the tissue site; and the tissue contact portion may comprise a hydrophobic layer that is gas permeable and liquid impermeable. In still other embodiments, the manifold for each of the plurality of massage therapy pads may comprise a plurality of cells formed by cell walls; the cell walls may form sealed cells, with no fluid communication between the plurality of cells through the cell walls; and each of the plurality of cells may be configured to be independently pressurized.
[0014] In some system embodiments, each of the plurality of massage therapy pads may receive pneumatic pressure from the pneumatic pressure source independently of the other massage therapy pads. The pneumatic pressure source of some embodiments may be configured to provide negative pressure to the plurality of massage therapy pads, positive pressure to the plurality of massage therapy pads, and/or both positive and negative pressure to the plurality of massage therapy pads. Some system embodiments may further comprise a controller configured to control delivery of pneumatic pressure from the pneumatic pressure source to the plurality of massage therapy pads. In some embodiments, for each of the plurality of massage therapy pads, the controller may cycle between negative pressure and positive pressure. In some embodiments, the controller may vary pneumatic pressure to each of the plurality of massage therapy pads based on one or more patterns.
[0015] Methods of massaging a tissue site are also described herein, and exemplary embodiments may comprise: placing the massage therapy pad on a tissue site with intact skin; and applying pneumatic pressure to the tissue site via the massage therapy pad. Applying pneumatic pressure may massage the tissue site, for example due to direct application of pneumatic pressure to the tissue site. In some embodiments, placing the massage therapy pad may comprise removably attaching the massage therapy pad to the tissue site. For example, the massage therapy pad may comprise a gel layer, and removably attaching the massage therapy pad may comprise pressing the gel layer into contact with the tissue site. In some embodiments, applying pneumatic pressure may comprise applying negative pressure of no more than 125 mmHg negative pressure to the tissue site. In some embodiments, applying pneumatic pressure may comprise applying positive pressure to the tissue site. In some embodiments, applying pneumatic pressure may comprise cyclically applying negative and positive pressure to the tissue site.
[0016] In some embodiments, applying pneumatic pressure may further comprise varying the pneumatic pressure based on one or more patterns. For example, each of the one or more patterns may vary pneumatic pressure to the massage therapy pad with a frequency between 30 seconds and 1 minute. Some method embodiments may further comprise removing the massage therapy pad from the tissue site; and refreshing an adhesive characteristic of the gel layer. For example, refreshing the adhesive characteristic of the gel layer may comprise cleaning the gel layer. Some embodiments may further comprise reattaching the massage therapy pad to the user, and reapplying pneumatic pressure via the massage therapy pad. In some embodiments, the massage therapy pad may comprise a tissue contact portion that is gas permeable and liquid impermeable, so that liquid is not drawn into the massage therapy pad from the tissue site upon application of pneumatic pressure.
[0017] Some method embodiments may use a plurality of massage therapy pads, for example applying pneumatic pressure simultaneously at a plurality of tissue sites via the plurality of massage therapy pads. In some embodiments, pneumatic pressure may be applied independently to each of the plurality of massage therapy pads. In some embodiments, two or more of the plurality of massage therapy pads may simultaneously massage the user with different patterns of direct application of pneumatic pressure. Some method embodiments may further comprise simultaneously releasing pneumatic pressure for all of the plurality of massage therapy pads.
[0018] Objectives, advantages, and a preferred mode of making and using the claimed subject matter may be understood best by reference to the accompanying drawings in conjunction with the following detailed description of illustrative embodiments. BRIEF DESCRIPTION OF THE DRAWINGS
[0019] Figure 1 is a functional block diagram of an example embodiment of a massage therapy system that can provide pneumatic pressure massage in accordance with this specification;
[0020] Figure 2 is another functional block diagram illustrating an embodiment of a massage therapy system with a plurality of massage therapy pads, configured to deliver pneumatic pressure massage to a plurality of tissue sites;
[0021] Figure 3 is a top plan view of an exemplary massage therapy pad on an exemplary tissue site;
[0022] Figure 4 is a cross-sectional view of the massage therapy pad of Figure 3;
[0023] Figure 5 is a bottom plan view of the massage therapy pad of Figure 3;
[0024] Figure 6 is a cross-sectional view of another exemplary massage therapy pad;
[0025] Figure 7 is a cross-sectional view of yet another exemplary massage therapy pad;
[0026] Figure 8 is a cross-sectional view of still another exemplary massage therapy pad;
[0027] Figure 9 is a cross-sectional view of yet another exemplary massage therapy pad;
[0028] Figure 10 is a schematic bottom plan view of still another exemplary massage therapy pad;
[0029] Figure 11 is an isometric view of an exemplary pneumatic connection interface with multi-lumen tube which may be used with the massage therapy pad embodiment of Figure 10;
[0030] Figure 12 is an isometric view of an exemplary pneumatic-pressure source embodiment with integral controller;
[0031] Figure 13 is an isometric view of yet another exemplary pneumatic -pressure source embodiment with integral controller;
[0032] Figures 14 - 20 are each schematic charts illustrating exemplary pneumatic pressure patterns for massage;
[0033] Figure 21 is a schematic view of an exemplary massage therapy device; and
[0034] Figure 22 is a schematic view of an exemplary massage therapy system.
DESCRIPTION OF EXAMPLE EMBODIMENTS
[0035] The following description of example embodiments provides information that enables a person skilled in the art to make and use the subject matter set forth in the appended claims, but it may omit certain details already well-known in the art. The following detailed description is, therefore, to be taken as illustrative and not limiting.
[0036] Figure 1 is a simplified functional block diagram of an example embodiment of a massage therapy system 100 that can provide pneumatic pressure massage therapy in accordance with this specification. The massage therapy system 100 may include a source or supply of pneumatic pressure, such as a pneumatic-pressure source 105, and a massage therapy pad 110, for example. The massage therapy system 100 may also include a regulator or controller, such as a controller 115. In some embodiments, the controller 115 may optionally be integral to (e.g. housed within and/or attached to) the pneumatic-pressure source 105. Additionally, the massage therapy system 100 may include sensors to measure operating parameters and provide feedback signals to the controller 115 indicative ofthe operating parameters. As illustrated in Figure 1, for example, the therapy system 100 may include a first sensor 120 and a second sensor 125 coupled to the controller 115.
[0037] In Figure 1, the pneumatic-pressure source 105 may be fluidly coupled to (e.g. in fluid communication with) the massage therapy pad 110. In some embodiments, the controller 115 may be electrically coupled to the pneumatic -pressure source 105. For example, as directed by the controller 115, the pneumatic-pressure source 105 may provide pneumatic pressure to the massage therapy pad 110 for massage.
[0038] Some components of the massage therapy system 100 may be housed within or used in conjunction with other components, such as sensors, processing units, alarm indicators, memory, databases, software, display devices, or user interfaces that further facilitate therapy. For example, in some embodiments, the pneumatic -pressure source 105 may be combined with the controller 115 and/or other components into a therapy unit.
[0039] In general, components of the massage therapy system 100 may be coupled directly or indirectly. Coupling may include fluid, mechanical, thermal, electrical, or chemical coupling (such as a chemical bond), or some combination of coupling in some contexts. For example, the pneumatic- pressure source 105 may be electrically coupled to the controller 115. The pneumatic-pressure source 105 may be fluidly coupled to one or more distribution components, such as the massage therapy pad 110, which provide a fluid path to a tissue site . In some embodiments, components may also be coupled by virtue of physical proximity, being integral to a single structure, or being formed from the same piece of material. For example, the controller 115 and pneumatic-pressure source 105 may be joined together in some embodiments.
[0040] A distribution component is preferably detachable, and may be disposable, reusable, or recyclable. The massage therapy pad 110 may be illustrative of a distribution component. A fluid conductor, for example fluidly coupling the pneumatic-pressure source 105 to the massage therapy pad 110, is another illustrative example of a distribution component. A "fluid conductor," in this context, broadly includes a tube, pipe, hose, conduit, or other structure with one or more lumina or open pathways adapted to convey a fluid between two ends. Typically, a tube is an elongated, cylindrical structure with some flexibility, but the geometry and rigidity may vary. Moreover, some fluid conductors may be molded into or otherwise integrally combined with other components. Distribution components may also include or comprise interfaces or fluid ports to facilitate coupling and de-coupling other components, including sensors and data communication devices.
[0041] A pneumatic-pressure supply, such as the pneumatic-pressure source 105, may be one or more reservoirs of air at a positive and/or negative pressure, or may be a manual or electrically- powered device, such as a vacuum pump, a suction pump, a wall suction port available at many healthcare facilities, or a micro-pump, for example. In some embodiments, the pneumatic-pressure source 105 may be a negative-pressure source. In other embodiments, the pneumatic -pressure source 105 may be a positive pressure source. In other embodiments, the pneumatic-pressure source 105 may be configured to provide both positive and negative pressure. “Positive pressure” generally refers to a pressure greater than a local ambient pressure, such as the ambient pressure in a local environment external to a sealed therapeutic environment. “Negative pressure” generally refers to a pressure less than a local ambient pressure, such as the ambient pressure in a local environment external to a sealed therapeutic environment. In many cases, the local ambient pressure may also be the atmospheric pressure at which a tissue site is located. Alternatively, the pressure may be less than a hydrostatic pressure associated with tissue at the tissue site. Unless otherwise indicated, values of pressure stated herein are gauge pressures. References to increases in negative pressure typically refer to a decrease in absolute pressure, while decreases in negative pressure typically refer to an increase in absolute pressure. While the amount and nature of negative pressure applied to a tissue site may vary according to therapeutic requirements, the pressure is generally a low vacuum, also commonly referred to as a rough vacuum, between -5 mm Hg (-667 Pa) and -500 mm Hg (-66.7 kPa). Common therapeutic ranges may be between -50 mm Hg (-9.9 kPa) and -300 mm Hg (-39.9 kPa).
[0042] A controller, such as the controller 115, may be a microprocessor or computer programmed to operate one or more components of the massage therapy system 100, such as the pneumatic -pressure source 105. In some embodiments, for example, the controller 115 may be a microcontroller, which generally comprises an integrated circuit containing a processor core and a memory programmed to directly or indirectly control one or more operating parameters of the massage therapy system 100. Operating parameters may include the power applied to the pneumatic -pressure source 105, the pressure generated by the pneumatic-pressure source 105, and/or the pressure distributed to the massage therapy pad 110, for example. The controller 115 is also preferably configured to receive one or more input signals, such as a feedback signal, and programmed to modify one or more operating parameters based on the input signals.
[0043] Sensors, such as the first sensor 120 and the second sensor 125, are generally known in the art as any apparatus operable to detect or measure a physical phenomenon or property, and generally provide a signal indicative of the phenomenon or property that is detected or measured. For example, the first sensor 120 and the second sensor 125 may be configured to measure one or more operating parameters of the massage therapy system 100. In some embodiments, the first sensor 120 may be a transducer configured to measure pressure in a pneumatic pathway and convert the measurement to a signal indicative of the pressure measured. In some embodiments, for example, the first sensor 120 may be a piezo-resistive strain gauge. The second sensor 125 may optionally measure operating parameters of the pneumatic-pressure source 105, such as the voltage or current, in some embodiments. Preferably, the signals from the first sensor 120 and the second sensor 125 are suitable as an input signal to the controller 115, but some signal conditioning may be appropriate in some embodiments. For example, the signal may need to be fdtered or amplified before it can be processed by the controller 115. Typically, the signal is an electrical signal, but may be represented in other forms, such as an optical signal.
[0044] The fluid mechanics of using a pneumatic-pressure source to alter pressure in another component or location, such as within a sealed therapeutic environment, can be mathematically complex. However, the basic principles of fluid mechanics applicable to pneumatic -pressure therapy are generally well-known to those skilled in the art, and the process of altering pressure may be described illustratively herein as “delivering,” “distributing,” or “generating” pneumatic pressure, for example.
[0045] Figure 2 is a simplified functional block diagram of another example embodiment of a massage therapy system 100 that can provide pneumatic -pressure massage therapy in accordance with this specification. While Figure 2 may share many similarities to Figure 1, it further illustrates that some exemplary systems may comprise a plurality of massage therapy pads 110. As shown in Figure 2, a single pneumatic-pressure source 105 may deliver pneumatic pressure to the plurality of massage therapy pads 110. For example the controller 115 may direct the pneumatic-pressure source 105 to deliver pneumatic pressure to each of the plurality of massage therapy pads 110. In some embodiments, the pneumatic -pressure source 105 can simultaneously deliver different levels and/or patterns of pneumatic pressure to each of the plurality of massage therapy pads 110 and/or can independently direct pneumatic pressure to each of the massage therapy pads 110.
[0046] Figure 3 is a top plan view of an exemplary massage therapy pad 110 of Figure 1 in place on a tissue site 305 and configured to apply pneumatic pressure to an intact (e.g. non-wound) tissue site, illustrating additional details that may be associated with some embodiments. As shown in Figure 3, the massage therapy pad 110 may include a port 310. In some embodiments, the port 310 may be configured to allow for fluid communication of pneumatic pressure (e.g. from a pneumatic- pressure source fluidly coupled to the massage therapy pad 110 via the port) into the massage therapy pad 110.
[0047] Figure 4 is a cross-section view of the massage therapy pad 110 of Figure 3, illustrating additional details that may be associated with some embodiments. In the embodiment of Figure 4, the massage therapy pad 110 may comprise a manifold 405; a cap 410 enclosing the manifold 405 on all but an exposed surface 415 of the manifold 405 (e.g. the tissue-site-facing surface of the manifold); and a port 310 configured for communication of pneumatic pressure into the cap 410 and/or into fluid communication with the manifold 405 (e.g. allowing fluid communication between the pneumatic- pressure source and the massage therapy pad). In the embodiment of Figure 4, the massage therapy pad 110 may further comprise a tissue contact portion, which may be an end cap 420 in some embodiments, spanning the exposed surface 415 and/or configured to allow fluid communication of pneumatic pressure from the manifold 405 to the tissue site 305. For example, the tissue contact portion may comprise a plurality of apertures 425 (e.g. through-holes) configured to allow fluid communication between the manifold 405 and the tissue site 305. In some embodiments, the apertures 425 may be configured (e.g. sized and/or spaced) to not substantially draw skin from the tissue site into an interior volume of the cap 410 and/or into the apertures 425. In some embodiments, the cap 410 may be coupled to the manifold 405 and/or tissue contact portion (e.g. the end cap 420). For example, the cap 410 may be welded to the tissue contact portion (e.g. the end cap 420). In some embodiments, the coupling between the cap 410 and the tissue contact portion may be sufficiently rigid as to substantially preclude movement (e.g. vibration) of the tissue contact portion with respect to the cap 410. In some embodiments, the tissue contact portion itself may be sufficiently rigid so as to not substantially vibrate across its surface. In some embodiments, the port 310 may be located on the cap 410 (e.g. on an upper portion, away from the tissue contact portion).
[0048] In the embodiment of Figure 4, the tissue contact portion comprises or consists essentially of the end cap 420. For example, in Figure 4, the end cap 420 may span the exposed surface 415 (e.g. sealingly attaching to the lower edge of the cap 410, such that the manifold 405 may be completely enclosed between the cap 410 and the end cap 420, and the end cap 420 may be located on the bottom and/or the tissue-site-facing side of the massage therapy pad 110), and comprises the plurality of apertures 425. In some embodiments, the end cap 420 may comprise or consist essentially of a gas impermeable (e.g. non-porous) material (e.g. with the apertures 425 therethrough to allow fluid communication between the manifold 405 and the tissue site). In some embodiments, the end cap 420 and/or tissue contact portion may comprise or consist essentially of a gel layer having the plurality of apertures 425. In some embodiments, the gel layer may be configured to removably attach the massage therapy pad to the tissue site and/or to seal the tissue contact portion to the tissue site. Some embodiments of the gel layer may also be configured for reuse (e.g. allowing the massage therapy pad to be attached, removed, and then reattached, for example multiple times). For example, the gel layer may be configured so that its adhesive characteristic may be refreshed by cleaning (e.g. with water and/or soap) between uses. In some embodiments, cleaning the gel layer may restore the adhesive characteristic of the gel layer to substantially its initial value. In other embodiments, cleaning the gel layer may at least restore the adhesive characteristic to a sufficient value to allow the massage therapy pad 110 to be re-adhered to the user (e.g. for multiple uses). In some embodiments, the massage therapy pad 110 may be low-profile (e.g. 1/16 - 1/8 inch thick). Some embodiments of the massage therapy pad may further comprise a release liner or reusable cover, which may be configured to protect the gel layer from contamination when the massage therapy pad 110 is not in use and to be removed to expose the gel layer for use. The release liner or reusable cover may be configured to protect the adhesive characteristic of the gel layer during storage (e.g. to not substantially impair the adhesive characteristic upon removal) and/or to be easily removable to expose the gel layer for use.
[0049] In some embodiments, for example as shown in Figure 4, the massage therapy pad 110 does not comprise a vibrating element. In some embodiments, none of the elements of the massage therapy pad 110 may be configured to substantially vibrate with respect to each other or to substantially vibrate themselves. For example, the tissue contact portion (e.g. end cap 420) may not substantially vibrate with respect to the cap 410, the manifold 405, and/orthe tissue site 305 when pneumatic pressure is applied to the massage therapy pad 110. The tissue contact portion (e.g. the end cap 420) also may not vibrate substantially across its surface (e.g. it may be sufficiently rigid so as to resist vibration). In some embodiments, applied pneumatic pressure (and patterns of variance) may not substantially vibrate or otherwise induce movement of the tissue contact portion. Rather, the applied pneumatic pressure may flow through the manifold 405 and the tissue contact portion (e.g. via the apertures 425) outward to the tissue site 305 to directly massage the tissue site 305 by pneumatic pressure directly acting on the tissue site (e.g. without any intervening element/component between the supplied pneumatic pressure and the tissue site). The air pressure may contact the tissue site, for example with suction effect, in some embodiments. In some instances, the tissue site 305 itself, or portions thereof, may actually vibrate due to the direct application of pneumatic pressure from the massage therapy pad 110. For example, in some instances the pneumatic pressure may press the tissue site 305 and/or cause an inward deflection of the tissue site (e.g. upon application of positive pressure to the tissue site), and may draw or pull the tissue site and/or cause outward deflection (e.g. upon application of negative pressure to the tissue site), and such movement may result in vibration of the tissue site 305 (e.g. based on the pattern of pressure variance). In some instances, variations in the negative and/or positive pneumatic pressure may induce vibrations, deformation, and/or movement at the tissue site 305. In some system embodiments and/or in some instances, vibrations may only be present and/or induced at the tissue site 305, and not within the massage therapy pad 110 itself.
[0050] The manifold 405 may provide a means for distributing pneumatic (e.g. air) pressure throughout the massage therapy pad 110 (e .g . within the cap 410) and/or from the port 310 to the tissue contact portion (e.g. the end cap 420). For example, the manifold 405 may be adapted to receive pneumatic pressure from a pneumatic -pressure source (e.g. through the port 310) and distribute the pneumatic pressure through multiple apertures, pores, flow channels, and/or pathways across the massage therapy pad 110, which may have the effect of drawing a vacuum (e.g. applying negative pneumatic pressure) across the tissue site 305 and/or applying positive pneumatic air pressure across the tissue site 305. In some embodiments, the manifold 405 may comprise or consist essentially of a material that does not significantly restrict distribution of pneumatic pressure from the port 310 to the tissue site 305 and/or throughout an inner cavity/space within the cap 410. In some embodiments, the massage therapy pad 110 (e.g. with manifold 405 within the cap 410) may be configured so that there is negligible pressure drop from port 310 to tissue contact portion. In some embodiments, the manifold 405 may comprise a porous material. For example, the manifold 405 may comprise a porous (e.g. open cell and/or reticulated) foam in some embodiments, while other embodiments of the manifold 405 may comprise a porous fabric. [0051] In some illustrative embodiments, the pathways of the manifold 405 may be interconnected to improve distribution of pneumatic pressure. In some illustrative embodiments, the manifold 405 may comprise or consist essentially of a porous material having interconnected fluid pathways (e.g. with good permeability of fluids while under pressure). For example, open-cell foam, porous tissue collections, and other porous material such as gauze or felted mat generally include pores, edges, and/or walls adapted to form interconnected fluid channels. Other suitable materials may include a 3D textile (Baltex, Muller, Heathcoates), non-woven (Libeltex, Freudenberg), a 3D polymeric structure (molded polymers, embossed and formed fdms, and fusion bonded fdms - such as Supracore), and mesh, for example . Liquids, gels, and other foams may also include or be cured to include apertures and fluid pathways. In some embodiments, the manifold 405 may additionally or alternatively comprise projections that form interconnected fluid pathways. For example, the manifold 405 may be molded to provide surface projections that define interconnected fluid pathways. Any or all of the surfaces of the manifold 405 may have an uneven, coarse, or jagged profile.
[0052] In some embodiments, the manifold 405 may comprise or consist essentially of reticulated foam having pore sizes and free volume that may vary according to needs of the massage therapy. For example, reticulated foam having a free volume of at least 90% may be suitable for many therapy applications, and foam having an average pore size in a range of 400-600 microns may be particularly suitable for some types of massage therapy. The tensile strength of the manifold 405 may also vary according to needs of the massage therapy. The 25% compression load deflection of the manifold 405 may be at least 0.35 pounds per square inch, in some embodiments, and the 65% compression load deflection may be at least 0.43 pounds per square inch. In some embodiments, the tensile strength of the manifold 405 may be at least 10 pounds per square inch. The manifold 405 may, in some embodiments, have a tear strength of at least 2.5 pounds per inch. In some embodiments, the manifold 405 may be foam comprised of polyols such as polyester or polyether, isocyanate such as toluene diisocyanate, and polymerization modifiers such as amines and tin compounds. In one non limiting example, the manifold 405 may be a reticulated polyurethane foam such as used in GRANUFOAM™ dressing or V.A.C. VERAFLO™ dressing, both available from KCI of San Antonio, Texas.
[0053] The manifold 405 may generally have a first planar surface and a second planar surface opposite the first planar surface. The thickness of the manifold 405 between the first planar surface and the second planar surface may also vary according to needs of the massage therapy. For example, the thickness of the manifold 405 may be decreased to relieve stress on other layers and to reduce tension on peripheral tissue. The thickness of the manifold 405 can also affect the conformability of the manifold 405 and/or massage therapy pad 110. In some embodiments, a thickness in a range of about 5 millimeters to 10 millimeters may be suitable. In some embodiments, a thickness in a range of about 1/16 to 1/8 inch may be suitable. In some embodiments, the manifold 405 may be configured to support the cap to prevent collapse under applied negative pneumatic pressure (e.g. maintaining open pathways for distribution of the pneumatic pressure) and/or to maintain an open treatment space within the cap 410.
[0054] The cap 410 may comprise or consist essentially of a material that can provide a seal adequate to maintain the pneumatic pressure at the tissue site for a given pneumatic-pressure source. For example, the cap 410 may provide adequate seal and/or be sufficiently gas impermeable to substantially prevent pneumatic (e.g. air) pressure within the cap 410 from escaping through the cap material, which may provide an effective fluid seal between two components or two environments (such as between a pneumatic pressurized environment within the massage therapy pad 110 and a local external environment). In some embodiments, the cap 410 may comprise or consist of, for example, an elastomeric film or membrane that can provide a seal adequate to maintain pneumatic (e.g. air) pressure at a tissue site for a given pneumatic-pressure source. The cap 410 may have a high moisture-vapor transmission rate (MVTR) in some applications. For example, the MVTR may be at least 250 grams per square meter per twenty-four hours in some embodiments, measured using an upright cup technique according to ASTM E96/E96M Upright Cup Method at 38°C and 10% relative humidity (RH). In some embodiments, an MVTR up to 5,000 grams per square meter per twenty-four hours may provide effective breathability and mechanical properties.
[0055] In some example embodiments, the cap 410 may be a polymer drape material, such as a polyurethane film, that is permeable to water vapor but substantially impermeable to liquid and/or air. Such drapes typically have a thickness in the range of 25-50 microns. For permeable materials, the permeability generally should be low enough that a desired pneumatic pressure may be maintained. For example, the cap 410 may comprise one or more of the following materials: polyurethane (PU), such as hydrophilic polyurethane; cellulosics; hydrophilic polyamides; polyvinyl alcohol; polyvinyl pyrrolidone; hydrophilic acrylics; silicones, such as hydrophilic silicone elastomers; natural rubbers; polyisoprene; styrene butadiene rubber; chloroprene rubber; polybutadiene; nitrile rubber; butyl rubber; ethylene propylene rubber; ethylene propylene diene monomer; chlorosulfonated polyethylene; polysulfide rubber; ethylene vinyl acetate (EVA); co-polyester; and polyether block polymide copolymers. Such materials are commercially available as, for example, Tegaderm® drape, commercially available from 3M Company, Minneapolis Minnesota; polyurethane (PU) drape, commercially available from Avery Dennison Corporation, Pasadena, California; polyether block polyamide copolymer (PEBAX), for example, from Arkema S.A., Colombes, France; and Inspire 2301 and Inpsire 2327 polyurethane fdms, commercially available from Coveris Advanced Coatings, Wrexham, United Kingdom. In some embodiments, the cap 410 may comprise INSPIRE 2301 having an MVTR (upright cup technique) of 2600 g/m2/24 hours and a thickness of about 30 microns. In some embodiments, the cap 410 may be configured to be self-supporting (e.g. to not collapse under applied negative pneumatic pressure based on its own structure, without having to rely on support from the manifold to prevent substantial collapse). In some embodiments, the cap 410 may be rigid or semi rigid. For example, the cap 410 may comprise or consist essentially of a rigid or semi-rigid silicone material. In some embodiments, the cap 410 may further comprise one or more support structures (such as ribs, which might be molded-in in some embodiments), which may increase rigidity and/or allow the cap 410 to be self-supporting (e .g . so that the cap 410 will not collapse under applied negative pneumatic pressure).
[0056] In some embodiments, the gel layer may comprise or consist essentially of a soft, pliable material, such as a tacky gel, suitable for providing a fluid and/or pneumatic seal with a tissue site 305, and may have a substantially flat surface. In some embodiments, the gel layer may be sufficiently tacky to hold the massage therapy pad 110 in position during usage, while also allowing the massage therapy pad 110 to be removed or re-positioned without trauma to the tissue site 305. For example, the gel layer may comprise, without limitation, a silicone gel, a soft silicone, hydrocolloid, hydrogel, polyurethane gel, polyolefin gel, hydrogenated styrenic copolymer gel, a foamed gel, a soft closed cell foam such as polyurethanes and polyolefins coated with an adhesive, polyurethane, polyolefin, hydrogenated styrenic copolymers, and/or a thermoplastic elastomer (TPE) gel. In some embodiments, the gel layer may include an adhesive surface on an underside and/or a patterned coating of acrylic. In other embodiments, the gel layer may comprise a low-tack adhesive layer instead of silicone. In some embodiments, the gel layer may have a thickness between about 200 microns (pm) and about 1000 microns (pm). For example, the gel layer may be about 1/32 inch thick. In some embodiments, the gel layer may be sufficiently thick to allow effective adhesion and/or sealing to an uneven tissue site. In some embodiments, the gel layer may have a low durometer. For example, the gel layer may have a hardness between about 5 Shore OO and about 80 Shore OO. Further, the gel layer may be comprised of hydrophobic or hydrophilic materials, in some embodiments. In some embodiments, the gel layer may be a hydrophobic-coated material. For example, the gel layer may be formed by coating a spaced material, such as, for example, woven, nonwoven, molded, or extruded mesh with a hydrophobic material. The hydrophobic material for the coating may be a soft silicone, for example.
[0057] As discussed above, the gel layer and/or end cap 420 may include apertures 425. The apertures 425 may be formed by cutting or by application of local RF or ultrasonic energy, for example, or by other suitable techniques for forming an opening. The apertures 425 may have a uniform distribution pattern, or may be randomly distributed on the gel layer. The apertures 425 in the gel layer (and/or other end cap 420) may have many shapes, including circles, squares, stars, ovals, polygons, slits, complex curves, rectilinear shapes, triangles, for example, or may have some combination of such shapes. Each of the apertures 425 may have uniform or similar geometric properties. For example, in some embodiments, each of the apertures 425 may be circular apertures, having substantially the same diameter. In some embodiments, the diameter of each of the apertures 425 may be between about 1 millimeter and about 50 millimeters. In other embodiments, the diameter of each of the apertures 425 may be between about 1 millimeter and about 20 millimeters. In other embodiments, geometric properties of the apertures 425 may vary. For example, the diameter of the apertures 425 may vary depending on the position of the apertures 425 in the gel layer and/or end cap 420. In some embodiments, the apertures 425 may be spaced substantially equidistant over the gel layer. In some embodiments, the plurality of apertures 425 may be substantially coextensive with the gel layer and/or end cap 420. Alternatively, the spacing of the apertures 425 may be irregular.
[0058] Figure 5 is a bottom plan view of the massage therapy pad 110 of Figure 3, illustrating additional details that may be associated with some embodiments. Figure 5 illustrates an exemplary embodiment of the tissue contact portion (e.g. the end cap 420) with apertures 425. The end cap 420 surface illustrated in Figure 5 may be configured to contact the tissue site. In embodiments in which the end cap 420 comprises or consists essentially of the gel layer, the outer (e.g. lower) gel layer surface would be exposed to contact the tissue site when in use.
[0059] Figure 6 is a cross-section view of an alternative massage therapy pad 110 embodiment, illustrating additional details that may be associated with some embodiments. In the embodiment of Figure 6, the tissue contact portion further comprises a separate end cap 420 (e.g. a separate support plate of gas impermeable material with a first set of apertures) and a separate gel layer 605 (e.g. with a second set of apertures), with the separate end cap 420 (e.g. support plate) located between the gel layer 605 and the manifold 405. The gel layer 605 may form the outer lower surface (e.g. tissue-site-facing surface) of the massage therapy pad 110. In some embodiments, the gel layer 605 may be positioned as the exterior surface of the tissue contact portion (e.g. so that the gel layer is configured to contact the tissue site when the massage therapy pad is applied to the tissue site for use). In some embodiments, the gel layer 605 may be similar to that described above (for example, comprising or consisting essentially of silicone gel and/or TPE gel in some embodiments). In some embodiments, the apertures 425 in the tissue contact portion may penetrate both the end cap 420 (e.g. support plate) and the gel layer 605. For example, the end cap 420 may comprises a first plurality of apertures (e.g. through-holes passing through the end cap/support plate), the gel layer 605 may comprise a second plurality of apertures (e.g. through-holes passing through the gel layer), and at least some of the second plurality of apertures in the gel layer 605 may correspond (e.g. align) with at least some of the first plurality of apertures in the end cap 420 (e.g. support plate). In some embodiments, each of the first plurality of apertures may align with one of the second plurality of apertures, so that together the first plurality of apertures in the end cap 420 and the second plurality of apertures in the gel layer 605 may form the plurality of apertures 425 in the tissue contact portion (e.g. passing through the entirety of the tissue contact portion, to allow fluid communication between the manifold 405 and the tissue site external to the massage therapy pad 110).
[0060] Figure 7 is a cross-section view of an alternative massage therapy pad 110 embodiment, illustrating additional details that may be associated with some embodiments. The massage therapy pad 110 of Figure 7 is similar to that shown in Figure 4, but further includes a layer, such as a hydrophobic layer 705, configured to substantially prevent entry of liquid into the manifold of the massage therapy pad 110. The massage therapy pad 110 and/or the tissue contact portion of Figure 7 may be configured to not substantially draw fluid from the tissue site. In some embodiments, the tissue contact portion may comprises the hydrophobic layer 705. In some embodiments, the hydrophobic layer 705 may be located adjacent to the manifold 405 and/or between the manifold 405 and the end cap 420 (e.g. which may consist essentially of or comprise a gel layer in some embodiments). In some embodiments, the hydrophobic layer 705 may be gas permeable (e.g. allowing transmission of pneumatic pressure from the manifold 405 to the tissue site) and substantially impermeable to liquid (e.g. preventing entry of liquid into the manifold). For example, the hydrophobic layer 705 may comprise a hydrophobic membrane or filter. In some embodiments, the hydrophobic layer 705 may substantially span the exposed surface 415 of the manifold 405, while in other embodiments the hydrophobic layer may at least span the apertures 425. Alternatively or additionally, the tissue contact portion may comprise an absorption layer (e.g. which may be removable/replaceable and/or disposable), which may be configured to absorb liquid in order to block entry of such liquid into the manifold 405. For example, an absorption layer (not shown) may be located between the manifold 405 and the end cap 420. Various massage therapy pad 110 embodiments may include such a hydrophobic layer 705 and/or absorption layer embodiment.
[0061] In some embodiments, the contact angle of the hydrophobic layer 705 may be in a range of at least 90 degrees to about 120 degrees, or in a range of at least 120 degrees to 150 degrees. Water contact angles can be measured using any standard apparatus. Although manual goniometers can be used to visually approximate contact angles, contact angle measuring instruments can often include an integrated system involving a level stage, liquid dropper such as a syringe, camera, and software designed to calculate contact angles more accurately and precisely, among other things. Non-limiting examples of such integrated systems may include the FTA125, FTA200, FTA2000, and FTA4000 systems, all commercially available from First Ten Angstroms, Inc., of Portsmouth, VA, and the DTA25, DTA30, and DTA100 systems, all commercially available from Kruss GmbH of Hamburg, Germany. Unless otherwise specified, water contact angles herein are measured using deionized and distilled water on a level sample surface for a sessile drop added from a height of no more than 5 cm in air at 20-25°C and 20-50% relative humidity. Contact angles reported herein represent averages of 5- 9 measured values, discarding both the highest and lowest measured values. The hydrophobicity of the hydrophobic layer 705 may be further enhanced with a hydrophobic coating of other materials in some embodiments.
[0062] In some embodiments, for example, the hydrophobic layer 705 may comprise or consist essentially of a hydrophobic polymer, such as a polyethylene film. The simple and inert structure of polyethylene can provide a surface that interacts little, if any, with biological tissues and fluids, providing a surface that may encourage the free flow of fluids and low adherence, which can be particularly advantageous for many applications. Other suitable polymeric films may include polyurethanes, acrylics, polyolefin (such as cyclic olefin copolymers), polyacetates, polyamides, polyesters, copolyesters, PEBAX block copolymers, thermoplastic elastomers, thermoplastic vulcanizates, polyethers, polyvinyl alcohols, polypropylene, polymethylpentene, polycarbonate, styreneics, silicones, fluoropolymers, and acetates. A thickness between 20 microns and 100 microns may be suitable for many applications. Films may be clear, colored, or printed. More polar films suitable for laminating to a polyethylene film include polyamide, co-polyesters, ionomers, and acrylics. To aid in the bond between a polyethylene and polar film, tie layers may be used, such as ethylene vinyl acetate, or modified polyurethanes. An ethyl methyl acrylate (EMA) film may also have suitable hydrophobic and welding properties for some configurations.
[0063] Figure 8 is a cross-section view of an alternative massage therapy pad 110 embodiment, illustrating additional details that may be associated with some embodiments. The embodiment of Figure 8 may be similar to the massage therapy pad 110 shown in Figure 4, but in some embodiments may not include an end cap. In Figure 8, the massage therapy pad 110 embodiment may further comprise an edge seal 805 configured to seal a perimeter of the exposed surface 415 and/orto removably attach the cap 410 to the tissue site. For example, the edge seal 805 in some embodiments may comprise a gel layer or ring located around the perimeter of the cap 410 (e.g. along the edge surface of the cap). In some embodiments, the edge seal 805 may comprise or consist essentially of materials similar to those described for the gel layer. In some embodiments, the tissue contact portion may comprise the exposed surface 415 of the manifold 405 and/or the edge seal 805. In some embodiments, the exposed surface 415 may be substantially even with the edge seal 805 (e.g. such that the exposed surface 415 may contact the tissue site when the massage therapy pad 110 is applied in place for use), while in other embodiments the edge seal 805 may extend outward past the exposed surface 415 (e.g. such that the exposed surface 415 may not contact the tissue site when the massage therapy pad 110 is applied in place for use).
[0064] Figure 9 is a cross-section view of an alternative massage therapy pad 110 embodiment, illustrating additional details that may be associated with some embodiments. The exemplary embodiment shown in Figure 9 may be similar to that shown in Figure 8, but in some embodiments may not include an edge seal. The tissue contact portion may comprise or consist essentially of the exposed surface 415 of the manifold 405 in some embodiments. For example, negative pressure applied to the massage therapy pad 110 may form sufficient suction to create a seal between the cap 410 and the tissue site. The exposed surface 415 of the manifold 405 may directly contact the tissue site and be in fluid communication with the tissue site (e.g. with the exposed surface 415 forming the tissue contact portion in some embodiments). In some embodiments, the massage therapy pad 110 may be held in contact with the tissue site manually, for example by a practitioner and/or the user, at least until pneumatic pressure suction is applied via the port 310.
[0065] Figure 10 is a schematic bottom plan view of an alternative massage therapy pad 110 embodiment, illustrating additional details that may be associated with some embodiments. In the embodiment of Figure 10, the manifold may comprise a plurality of cells 1005 (e.g. with each cell 1005 comprising cell walls 1010 configured to separate and seal the cells from each other). One or more cell walls 1010 may form each of the sealed cells 1005, with no fluid communication between cells 1005 through the cell walls 1010. So in some embodiments, each of the cells 1005 may be sealed from the other cells (e.g. no fluid communication between cells). In some embodiments, each of the plurality of cells 1005 may comprise one or more ofthe apertures 425 (e.g. configured to allow fluid communication between the interior of the cells 1005 and the tissue site). The cells 1005 may be substantially sealed except for these apertures 425. In some embodiments, the cells 1005 may form a honeycomb-like structure. For example, the cell walls 1010 may form a plurality of identical cells 1005, which may each be hexagonal in cross-section shape in some embodiments. In some embodiments, the plurality of cells 1005 may be formed by a lattice (e.g. grid) of cell walls 1010. For example, only a single layer of cells 1005 may be formed in the cap, with the dividing cell walls 1010 extending between the inner surface of the cap and the exposed surface or end cap (e.g. tissue contact portion). For example, each cell 1005 may be bounded by the cap, the cell walls 1010, and the tissue contact portion. In some embodiments, each cell 1005 may be sealed except for the one or more apertures 425 in the tissue contact portion.
[0066] In some embodiments (for example, in which the manifold formed by the cell walls 1010 supports the cap), the cell walls 1010 may be rigid or semi-rigid. In other embodiments (for example, in which the cap is self-supporting), the cell walls 1010 may be flexible and/or non-supporting. In some embodiments, the support features for the cap (e.g. configured to support the cap to prevent draw-down or collapse under any applied negative pressure) may comprise the cell walls 1010. In some embodiments, each cell 1005 may comprise open space between the cell walls 1010. For example, the cell structure formed by the walls may be empty (e.g. filled with air) with no other manifold material filling the cells 1005 between the cell wall 1010 structure. In other embodiments, each cell 1005 may comprise porous manifold material (e.g. porous foam or fabric, not shown) within the cell walls 1010 (e.g. substantially filling the cells). In some embodiments, each cell 1005 may be configured to be independently pressurized (e.g. configured so that pneumatic pressure may be applied independently to each cell).
[0067] Figure 11 is a schematic isometric view of an exemplary means for independently supplying pneumatic pressure to each of the plurality of cells of the massage therapy pad 110 of Figure 10, illustrating additional details that may be associated with some embodiments. In Figure 11, the means for independently supplying pneumatic pressure may comprise a pneumatic connection interface 1105, configured to supply pneumatic pressure independently to each cell. For example, the pneumatic connection interface 1105 may comprise a plurality of conduits 1110, with each conduit 1110 configured to independently provide fluid communication between one of the cells and the external environment (e.g. the pneumatic-pressure source outside the cap, via the port). In some embodiments, the pneumatic connection interface 1105 (e.g. with branching independent conduits 1110) could be molded as part of the inner surface of the cap. In some embodiments, the means for independently supplying pneumatic pressure may also comprise a multi-lumen conduit 1115 having a plurality of lumens 1120 for independent application of pneumatic pressure to each of the cells. For example, each of the plurality of lumens 1120 may be in fluid communication with one of the cells via one of the conduits 1110 of the pneumatic connection interface 1105.
[0068] Figure 12 is a schematic isometric view of an exemplary pneumatic-pressure source 105 of Figure 1 for use with one or more of the massage therapy pads (e.g. supplying pneumatic pressure to the one or more massage therapy pads), illustrating additional details that may be associated with some embodiments. In some embodiments, the pneumatic-pressure source 105 may comprise or consist essentially of a pneumatic pump (e.g. an electric pump or a manual pump configured to provide pneumatic pressure, which might be positive or negative). In some embodiments, the pneumatic- pressure source 105 may be configured to provide negative pneumatic pressure. In some embodiments, the pneumatic-pressure source 105 may be configured to provide positive pneumatic pressure. In some embodiments, the pneumatic-pressure source 105 may be configured to provide both positive and negative pneumatic pressure.
[0069] In some embodiments, the pneumatic-pressure source 105 may comprise a plurality of pressure outlets 1205, so that each of the plurality of massage therapy pads may independently receive pneumatic pressure from one of the pressure outlets 1205 of the pneumatic-pressure source 105 (e.g. each pressure outlet 1205 may be independently pressurized). For example, Figure 12 illustrates an embodiment with four pressure outlets 1205, allowing a single pneumatic-pressure source 105 to independently and/or simultaneously operate up to four massage therapy pads. In some embodiments, the pneumatic-pressure source 105 may be configured to simultaneously operate and provide pressure to all of the pressure outlets 1205 (e.g. all of the massage therapy pads coupled to the source). For example, the pneumatic-pressure source 105 may be configured to be able to provide maximum pressure (e.g. for the pressure pattem(s) applied to the pressure outlets) to all pressure outlets simultaneously. In other embodiments, the pneumatic-pressure source 105 may cycle and/or alternate pressure between two or more of the pressure outlets 1205 (e.g. not all pressure outlets 1205 may receive maximum pressure or any pressure at the same time). In some embodiments, the massage pressure patterns for two or more pressure outlets 1205 may be offset, so that the two or more pressure outlets 1205 do not all receive maximum pressure simultaneously (e.g. the maximum pressure may be applied to one pressure outlet while the minimum pressure may be applied to another pressure outlet, which may allow for a smaller overall pneumatic-pressure source 105 to provide the required pressure for all pressure outlets 1205). In some embodiments, the amount of negative pressure (e.g. the maximum negative pressure) provided to each pressure outlet 1205 by the pneumatic-pressure source 105 may be 125 mmHg negative pressure or less, 100 mmHg negative pressure or less, 80 mmHg negative pressure or less, 60 mmHg negative pressure or less, or 50 mmHg negative pressure or less. In some embodiments, absolute pneumatic pressure (e.g. the absolute value of the pneumatic pressure) may range between 40 - 125 mmHg, 40 - 100 mmHg, 40 - 80 mmHg, 40 - 60 mmHg, 40 - 50 mmHg, 50 - 80 mmHg, or 50 - 60 mmHg. [0070] Some embodiments may further comprise a controller 115 configured to control delivery of pneumatic pressure from the pneumatic-pressure source 105 (e.g. from the pressure outlets 1205) to the one or more massage therapy pads. In some embodiments, the controller 115 may have one or more inputs 1210 (e.g. buttons) configured to allow selection of the intensity level (e.g. maximum intensity or absolute pneumatic pressure) for the pneumatic pressure and/or one or more inputs 1215 (e.g. buttons) configured to allow selection of the pattern of variation for the pneumatic pressure. For example, in Figure 12, the controller 115 may comprise three buttons for intensity selection (e.g. high, medium, and low), and five buttons for patterns selection (e.g. allowing the user to select one of five patterns for the pneumatic pressure application for massage). In some embodiments, one of the buttons may also cycle through to an off configuration for the pneumatic -pressure source (or there may be a separate input (e.g. button) to control power). Some embodiments may also comprise one or more indicators (such as LED lights), for example configured to indicate the level, pattern, and/or power setting currently selected. The embodiment of Figure 12 may also comprise a pressure release button 1220, configured to simultaneously release the pneumatic pressure from all pressure outlets 1205. In some embodiments, the controller 115 may be integral to the pneumatic -pressure source 105 (for example, with both located within a common housing).
[0071] Figure 13 is a schematic isometric view of an alternative exemplary pneumatic- pressure source 105, illustrating additional details that may be associated with some embodiments. The pneumatic -pressure source 105 of Figure 13 is similar to that of Figure 12, but may consolidate some button functions. For example, a single button may allow selection of the intensity level and/or power (e.g. by allowing a user to cycle through various intensity levels available), and/or a single button may allow selection of the massage pattern and/or power (e.g. by allowing a user to cycle through various patterns available). In some embodiments, the controller 115 may only have two buttons.
[0072] In some embodiments, the pneumatic pressure may be controlled to deliver a plurality of intermittent durations of pneumatic pressure to the tissue site (e.g. via the pressure outlets) to massage the tissue site. In some embodiments, the controller 115 may be configured to vary pneumatic pressure based on one or more pattern (e.g. intensity and/or wave profile). In some embodiments, the controller 115 may cycle between negative pressure and positive pressure. In some embodiments, the pattern may vary pneumatic pressure with a frequency period between 30 seconds and 1 minute. For embodiments with manifolds having a plurality of cells (such as shown in Figure 10), each cell may independently receive the same pneumatic pressure or the pneumatic pressure for each cell may be independently controlled (e.g. a pattern of rotation from one cell to another - for example clockwise).
[0073] Figure 14 is a schematic chart view of an exemplary pattern of pneumatic pressure variation for pneumatic massage therapy, illustrating additional details that may be associated with some embodiments. The pattern shown in Figure 14 comprises a square wave with respect to absolute pneumatic pressure, having a wavelength } between peaks. Since the pattern is shown with respect to absolute pneumatic pressure, the actual pneumatic pressure peaks could all be positive, could all be negative, or could include both positive and negative pressure. In various embodiments, the exemplary patterns shown may be modified without changing the underlying principle. For example, the wave pattern in Figure 14 could have its minimum absolute pneumatic pressure set at zero in some embodiments.
[0074] Figure 15 is a schematic chart view of another exemplary pattern of pneumatic pressure variation for pneumatic massage therapy, illustrating additional details that may be associated with some embodiments. The pattern shown in Figure 15 comprises a triangular wave with respect to absolute pneumatic pressure, which rises steadily to the peak (e.g. maximum value) and then drops quickly to its minimum value (e.g. valley) and has a wavelength between peaks. In Figure 15, the minimum pneumatic pressure value is zero. Since the pattern is shown with respect to absolute pneumatic pressure, the actual pneumatic pressure peaks could all be positive, could all be negative, or could include both positive and negative pressure.
[0075] Figure 16 is a schematic chart view of another exemplary pattern of pneumatic pressure variation for pneumatic massage therapy, illustrating additional details that may be associated with some embodiments. The pattern shown in Figure 16 comprises a sinusoidal wave with respect to absolute pneumatic pressure, having a wavelength between peaks. Since the pattern is shown with respect to absolute pneumatic pressure, the actual pneumatic pressure peaks could all be positive, could all be negative, or could include both positive and negative pressure.
[0076] Figure 17 is a schematic chart view of another exemplary pattern of pneumatic pressure variation for pneumatic massage therapy, illustrating additional details that may be associated with some embodiments. The pattern shown in Figure 17 comprises a wave with respect to absolute pneumatic pressure, having a wavelength between peaks. The wave pattern may curve upward quickly, and then fall steadily. Since the pattern is shown with respect to absolute pneumatic pressure, the actual pneumatic pressure peaks could all be positive, could all be negative, or could include both positive and negative pressure.
[0077] Figure 18 is a schematic chart view of another exemplary pattern of pneumatic pressure variation for pneumatic massage therapy, illustrating additional details that may be associated with some embodiments. The pattern shown in Figure 18 comprises two square wave patterns repeated cyclically over time with respect to absolute pneumatic pressure. For example, the first wave pattern, having a wavelength 3d between peaks, may span a time period Tl, the second wave pattern, having a wavelength 12 between peaks, may follow the first wave pattern in time and span time period T2, before the first wave pattern repeats. Since the patterns are shown with respect to absolute pneumatic pressure, the actual pneumatic pressure peaks could all be positive, could all be negative, or could include both positive and negative pressure.
[0078] Figure 19 is a schematic chart view of another exemplary pattern of pneumatic pressure variation for pneumatic massage therapy, illustrating additional details that may be associated with some embodiments. The pattern shown in Figure 19 comprises a series of building waves (e.g. triangular waves, each building steadily to the peak, before quickly dropping to the minimum value, with each succeeding wave in the series having a larger peak). The wave pattern may repeat every time period T3. For example, in Figure 19 each time speriod T3 may comprise three waves, with the first wave being the smallest and the last wave being the largest. Since the patterns are shown with respect to absolute pneumatic pressure, the actual pneumatic pressure peaks could all be positive, could all be negative, or could include both positive and negative pressure.
[0079] Figure 20 is a schematic chart view of another exemplary pattern of pneumatic pressure variation for pneumatic massage therapy, illustrating additional details that may be associated with some embodiments. The pattern shown in Figure 20 comprises a square wave pattern repeated cyclically over time with respect to pneumatic pressure. In Figure 20, the waves vary between positive and negative pneumatic pressure. For example, the wave pattern may vary from about 125 mmHg (or less) positive pressure to about -125 mmHg (or less) negative pressure (or alternatively from about 40 mmHg positive pressure to about -40 mmHg negative pressure). The exemplary pneumatic pressure patterns illustrated in Figures 14-20 are merely illustrative, illustrating several possible features of some pattern embodiments.
[0080] Figure 21 is a schematic view of an exemplary massage therapy device 2105 applied to an exemplary tissue site 305. The massage therapy device 2105 of Figure 21 comprises a pneumatic pressure-source 105 fluidly coupled to a massage therapy pad 110, and configured to provide pneumatic pressure to the manifold of the massage therapy pad 110. The pneumatic -pressure source 105 for Figure 21 may comprise any of those described herein. The massage therapy pad 110 for Figure 21 may comprise any of those described herein. The massage therapy pad 110 shown in Figure 21 is applied with its tissue contact portion contacting and in fluid communication with the tissue site. In Figure 21, pneumatic pressure from the pneumatic -pressure source 105 may be fluidly communicated to the manifold within the massage therapy pad 110, and then may be fluidly communicated from the manifold, through the tissue contact portion (e.g. apertures), to the tissue site. The pneumatic pressure directly contacts the tissue site. In some embodiments, the massage therapy device 2105 may be wearable (e.g. by ambulatory user). For example, the pneumatic-pressure source 105 may be sufficiently small and lightweight to allow for convenient, comfortable wearing. This may be particularly true if the massage therapy pad 110 comprises a gel layer or other adhesive or retaining means for attachment to the tissue site.
[0081] Figure 22 is a schematic view of an exemplary pneumatic massage therapy system 100 applied to a plurality of distinct exemplary tissue sites on a user. The system of Figure 22 comprises a single pneumatic pressure-source 105 fluidly coupled to a plurality of massage therapy pads 110, and configured to provide pneumatic pressure simultaneously and/or independently to each of the plurality of massage therapy pads 110. The pneumatic-pressure source 105 for Figure 22 may comprise any of those described herein. Each of the massage therapy pads 110 for Figure 22 may comprise any of those described herein. The massage therapy pads 110 are applied with tissue contact portion contacting and in fluid communication with the corresponding tissue site. As shown in Figure 22, the controller 125 may be integral to the pneumatic-pressure source 105 in this exemplary embodiment. In the embodiment of Figure 22, only a single pneumatic -pressure source 105 provides pressure to all of the massage therapy pads 110.
[0082] The pneumatic pressure massage device and system embodiments may be used to provide massage therapy to a user/patient. For example, the device and system embodiments may provide pneumatic pressure massage therapy by directly applying pneumatic pressure to one or more tissue sites (e.g. with the tissue sites experiencing pneumatic pressure via contact with a vacuum and/or pressurized air). Some methods embodiments formassaging a tissue site using pneumatic pressure may comprise: placing the massage therapy pad on a tissue site (e.g. with intact skin); and applying pneumatic pressure to the tissue site via the massage therapy pad. Applying pneumatic pressure may massage the tissue site, for example due to direct application of pneumatic pressure to the tissue site (e.g. with positive and/or negative pneumatic pressure directly applied to and/or contacting the skin). In some embodiments, placing the massage therapy pad may comprise removably attaching the massage therapy pad to the tissue site. For example, the massage therapy pad may comprise a gel layer, and removably attaching the massage therapy pad may comprise pressing the gel layer into contact with the tissue site. In some embodiments, applying pneumatic pressure may comprise applying negative pressure, for example of no more than 125 mmHg negative pressure, to the tissue site. In some embodiments, applying pneumatic pressure may comprise applying positive pressure to the tissue site. In some embodiments, applying pneumatic pressure may comprise cyclically applying negative and positive pressure to the tissue site.
[0083] In some embodiments, applying pneumatic pressure may further comprise varying the pneumatic pressure based on one or more patterns (e.g. using one or more of the patterns described above, or alternative patterns varying the pneumatic pressure, to induce massage). For example, each of the one or more patterns may vary pneumatic pressure to the massage therapy pad with a frequency period between 30 seconds and 1 minute. Some method embodiments may further comprise removing the massage therapy pad from the tissue site; and refreshing an adhesive characteristic of the gel layer. For example, refreshing the adhesive characteristic of the gel layer may comprise cleaning the gel layer. Some embodiments may further comprise reattaching the massage therapy pad to the user, and reapplying pneumatic pressure via the massage therapy pad. In some embodiments, the massage therapy pad may comprise a tissue contact portion that is gas permeable and liquid impermeable, so that liquid is not drawn into the massage therapy pad from the tissue site upon application of pneumatic pressure. In some embodiments, the configuration of the massage therapy pad may ensure that substantially no elements of the massage therapy pad vibrate substantially. For example, the tissue contact portion may not substantially vibrate in response to the pneumatic pressure patterns.
[0084] Some method embodiments may use a plurality of massage therapy pads, for example applying pneumatic pressure simultaneously at a plurality of tissue sites via the plurality of massage therapy pads. In some embodiments, pneumatic pressure may be applied independently to each of the plurality of massage therapy pads (e.g. using a single pneumatic-pressure source). In some embodiments, two or more of the plurality of massage therapy pads may simultaneously massage the user with different patterns of direct application of pneumatic pressure. Some method embodiments may further comprise simultaneously releasing pneumatic pressure for all of the plurality of massage therapy pads.
[0085] The systems, apparatuses, and methods described herein may provide significant advantages. For example, massage may be automated (e.g. non-manual), and the automated massage process may eliminate or reduce the need for trained professional supervision. By using direct application of pneumatic pressure to the tissue site(s) for the massage, safety concerns associated with electrical-type massagers, such as TENS units, may be eliminated. For example, the pneumatic massage device may be used near the user’s heart and/or neck and/or may be used by users/patients with heart problems. Additionally, pneumatic massage may help to open fluid pathways within the tissue site, in addition to massage effects due to physical movement and/or deformation of the tissue site by the pneumatic pressure. Embodiments with a gel layer (or other such adhesive tissue contact portion) may allow for hands-free usage, which may be more convenient, may be more relaxing, and/or may allow for self-application (e.g. use without the need for an additional practitioner other than the patient, with the massage therapy pads capable of being self-placed on the body). The gel layer may also allow for the adhesive characteristic to be refreshed, allowing the massage therapy pad to be re-used repeatedly. Embodiments in which the manifold comprises a plurality of sealed, independent cells may also assist in maintaining pneumatic pressure massage, even over an uneven surface, since a lack of seal for one cell may not render the other cells inoperable. Some embodiments, for example with low-profde massage therapy pads and/or a smaller, portable pneumatic -pressure source and/or controller, may also allow for massage on an ambulatory user/patient.
[0086] While shown in a few illustrative embodiments, a person having ordinary skill in the art will recognize that the systems, apparatuses, and methods described herein are susceptible to various changes and modifications that fall within the scope of the appended claims. Moreover, descriptions of various alternatives using terms such as “or” do not require mutual exclusivity unless clearly required by the context, and the indefinite articles "a" or "an" do not limit the subject to a single instance unless clearly required by the context. Components may be also be combined or eliminated in various configurations for purposes of sale, manufacture, assembly, or use. For example, in some configurations the dressing 110, the container 115, or both may be eliminated or separated from other components for manufacture or sale. In other example configurations, the controller 130 may also be manufactured, configured, assembled, or sold independently of other components.
[0087] The appended claims set forth novel and inventive aspects of the subject matter described above, but the claims may also encompass additional subject matter not specifically recited in detail. For example, certain features, elements, or aspects may be omitted from the claims if not necessary to distinguish the novel and inventive features from what is already known to a person having ordinary skill in the art. Features, elements, and aspects described in the context of some embodiments may also be omitted, combined, or replaced by alternative features serving the same, equivalent, or similar purpose without departing from the scope of the invention defined by the appended claims.

Claims

CLAIMS What is claimed is:
1. A massage therapy pad for applying pneumatic pressure to a tissue site, comprising: a manifold; a cap enclosing the manifold on all but an exposed surface of the manifold; and a port configured for communication of pneumatic pressure into the cap.
2. The pad of claim 1, wherein the cap is gas impermeable.
3. The pad of any of claims 1-2, further comprising an edge seal configured to seal a perimeter of the exposed surface and to removably attach the cap to the tissue site.
4. The pad of claim 3, wherein the edge seal comprises a gel seal located around the perimeter.
5. The pad of claim 1, further comprising a tissue contact portion spanning the exposed surface and configured to provide fluid communication of pneumatic pressure from the manifold to the tissue site.
6. The pad of claim 5, wherein the cap is coupled to the tissue contact portion.
7. The pad of claim 5, wherein the tissue contact portion comprises a plurality of apertures configured to allow fluid communication between the manifold and the tissue site.
8. The pad of claim 5, wherein the tissue contact portion comprises the exposed surface of the manifold.
9. The pad of claim 5, wherein the tissue contact portion comprises an end cap having a plurality of apertures configured to allow fluid communication between the manifold and the tissue site.
10. The pad of claim 9, wherein the end cap comprises a gel layer.
11. The pad of claim 5, wherein: the tissue contact portion comprises a gel layer having a plurality of apertures; the gel layer is configured to removably attach the massage therapy pad to the tissue site and to seal the massage therapy pad to the tissue site; and the plurality of apertures are configured to allow fluid communication between the manifold and the tissue site.
12. The pad of claim 11, wherein: the tissue contact portion further comprises an end cap formed of gas impermeable material and located between the gel layer and the manifold; the end cap comprises a plurality of apertures; and the apertures in the gel layer align with the apertures in the end cap.
13. The pad of any of claims 5-12, wherein the tissue contact portion comprises a hydrophobic layer that is gas permeable and liquid impermeable.
14. The pad of any of claims 5-13, wherein the tissue contact portion comprises a disposable absorption layer.
15. The pad of any of claims 1-14, wherein the manifold comprises a porous material.
16. The pad of any of claims 1-15, wherein the manifold is configured to support the cap to prevent collapse upon application of negative pneumatic pressure.
17. The pad of any of claims 1-16, wherein the cap is configured to be self-supporting, so as to not collapse upon application of negative pneumatic pressure.
18. The pad of any of claims 1-14, wherein the manifold comprises a plurality of cells formed by cell walls, with no fluid communication between the plurality of cells through the cell walls.
19. A massage therapy pad for applying pneumatic pressure to a tissue site, comprising: a manifold comprising a plurality of cells formed by cell walls; a cap enclosing the manifold on all but an exposed surface of the manifold; a tissue contact portion spanning the exposed surface and configured to provide fluid communication of pneumatic pressure from the manifold to the tissue site; and a port configured for communication of pneumatic pressure into the cap; wherein: the cell walls form sealed cells, with no fluid communication between the plurality of cells through the cell walls; and each of the plurality of cells is configured to be independently pressurized.
20. The pad of claim 19, further comprising a pneumatic connection interface configured to supply pneumatic pressure independently to each of the plurality of cells.
21. The pad of any of claims 19-20, further comprising a multi -lumen conduit having a plurality of lumens for independent application of pneumatic pressure to each of the plurality of cells.
22. The pad of any of claims 19-21, wherein each of the plurality of cells comprises two or more of the cell walls and manifold material between the cell walls.
23. The pad of any of claims 19-21, wherein each of the plurality of cells comprises two or more of the cell walls and open space between the cell walls.
24. A massage device configured to apply pneumatic pressure to a tissue site, comprising: a pneumatic pressure source; and a massage therapy pad fluidly coupled to the pneumatic pressure source; wherein the massage therapy pad comprises: a manifold; a cap enclosing the manifold on all but an exposed surface of the manifold; and a port configured for communication of pneumatic pressure into the massage therapy pad.
25. The device of claim 24, wherein: the massage therapy pad further comprises a tissue contact portion spanning the exposed surface; the tissue contact portion comprises a gel layer having a plurality of apertures; the gel layer is configured to removably attach the massage therapy pad to the tissue site and to seal the massage therapy pad to the tissue site; and the plurality of apertures are configured to allow fluid communication between the manifold and the tissue site.
26. The device of claim 24, wherein: the massage therapy pad further comprises a tissue contact portion spanning the exposed surface and configured to provide fluid communication of pneumatic pressure from the manifold to the tissue site; and the tissue contact portion comprises a hydrophobic layer that is gas permeable and liquid impermeable.
27. The device of claim 24, wherein: the manifold comprising a plurality of cells formed by cell walls; the cell walls form sealed cells, with no fluid communication between the plurality of cells through the cell walls; each of the plurality of cells is configured to be independently pressurized; and the massage therapy pad further comprises a tissue contact portion spanning the exposed surface and configured to provide fluid communication of pneumatic pressure from the manifold to the tissue site.
28. The device of any of claims 24-27, wherein the pneumatic pressure source is configured to provide positive pressure.
29. The device of any of claims 24-27, wherein the pneumatic pressure source is configured to provide negative pressure.
30. The device of any of claims 24-27, wherein the pneumatic pressure source is configured to provide both positive and negative pressure.
31. The device of claim 30, further comprising a controller configured to control delivery of pneumatic pressure from the pneumatic pressure source to the massage therapy pad; wherein the controller cycles between negative pressure and positive pressure.
32. The device of any of claims 24-31, further comprising a controller configured to control delivery of pneumatic pressure from the pneumatic pressure source to the massage therapy pad by varying pneumatic pressure based on one or more patterns.
33. The device of claim 32, wherein the one or more patterns each varies pneumatic pressure with frequency between 30 seconds and 1 minute, and the amount of negative pressure provided by the pneumatic pressure source is approximately 125 mmHg negative pressure or less.
34. A system configured to apply pneumatic pressure to a plurality of tissue sites on a user, comprising: a pneumatic pressure source; and a plurality of massage therapy pads each fluidly coupled to the pneumatic pressure source; wherein each of the plurality of massage therapy pads comprises: a manifold; and a cap enclosing the manifold on all but an exposed surface of the manifold.
35. The system of claim 34, wherein: each of the plurality of massage therapy pads further comprises a tissue contact portion spanning the exposed surface; the tissue contact portion comprises a gel layer having a plurality of apertures; the gel layer is configured to removably attach and seal to the tissue site; and the plurality of apertures are configured to allow fluid communication between the manifold and the tissue site.
36. The system of claim 34, wherein: each of the plurality of massage therapy pads further comprises a tissue contact portion spanning the exposed surface and configured to provide fluid communication of pneumatic pressure from the manifold to the tissue site; and the tissue contact portion comprises a hydrophobic layer that is gas permeable and liquid impermeable.
37. The system of claim 34, wherein: the manifold for each of the plurality of massage therapy pads comprises a plurality of cells formed by cell walls; the cell walls form sealed cells, with no fluid communication between the plurality of cells through the cell walls; and each of the plurality of cells is configured to be independently pressurized.
38. The system of any of claims 34-37 wherein each of the plurality of massage therapy pads receives pneumatic pressure from the pneumatic pressure source independently of the other massage therapy pads.
39. The system of any of claims 34-38, wherein the pneumatic pressure source is configured to provide negative pressure to the plurality of massage therapy pads.
40. The system of any of claims 34-38, wherein the pneumatic pressure source is configured to provide positive pressure to the plurality of massage therapy pads.
41. The system of any of claims 34-38, wherein the pneumatic pressure source is configured to provide both positive and negative pressure to the plurality of massage therapy pads.
42. The system of claim 41, further comprising a controller configured to control delivery of pneumatic pressure from the pneumatic pressure source to the plurality of massage therapy pads, wherein for each of the plurality of massage therapy pads, the controller cycles between negative pressure and positive pressure.
43. The system of any of claims 34-42, further comprising a controller configured to control delivery of pneumatic pressure from the pneumatic pressure source to the plurality of massage therapy pads by varying pneumatic pressure to each of the plurality of massage therapy pads based on one or more patterns.
44. A method of massaging a tissue site using a massage therapy pad, comprising: placing the massage therapy pad on a tissue site with intact skin; and applying pneumatic pressure to the tissue site via the massage therapy pad; wherein applying pneumatic pressure massages the tissue site.
45. The method of claim 44, wherein: placing the massage therapy pad comprises removably attaching the massage therapy pad to the tissue site; the massage therapy pad comprises a gel layer; and removably attaching the massage therapy pad comprises pressing the gel layer into contact with the tissue site.
46. The method of any of claims 44-45, wherein applying pneumatic pressure comprises applying negative pressure of no more than 125 mmHg negative pressure to the tissue site.
47. The method of any of claim 44-46, wherein applying pneumatic pressure further comprises applying positive pressure to the tissue site.
48. The method of any of claims 47, wherein applying pneumatic pressure further comprises cyclically applying negative and positive pressure to the tissue site.
49. The method of any of claims 44-48, wherein applying pneumatic pressure further comprises varying the pneumatic pressure based on one or more patterns.
50. The method of claim 49, wherein each of the one or more patterns varies pneumatic pressure to the massage therapy pad with a frequency between 30 seconds and 1 minute.
51. The method of any of claims 45-50, further comprising: removing the massage therapy pad from the tissue site; and refreshing an adhesive characteristic of the gel layer.
52. The method of claim 51, wherein refreshing the adhesive characteristic of the gel layer comprises cleaning the gel layer.
53. The method of any of claims 51-52, further comprising reattaching the massage therapy pad to the user, and reapplying pneumatic pressure via the massage therapy pad.
54. The method of any of claims 44-53, wherein the massage therapy pad comprises a tissue contact portion that is gas permeable and liquid impermeable, so that liquid is not drawn into the massage therapy pad from the tissue site upon application of pneumatic pressure.
55. The method of any of claims 44-54, wherein the method uses a plurality of massage therapy pads and applies pneumatic pressure simultaneously at a plurality of tissue sites via the plurality of massage therapy pads.
56. The method of claim 55, wherein pneumatic pressure is applied independently to each of the plurality of massage therapy pads.
57. The method of any of claims 55-56, wherein two or more of the plurality of massage therapy pads simultaneously massage the user with different patterns of direct application of pneumatic pressure.
58. The method of any of claims 55-57, further comprising simultaneously releasing pneumatic pressure for all of the plurality of massage therapy pads.
59. The systems, apparatuses, and methods substantially as described herein.
PCT/IB2020/057941 2019-08-28 2020-08-25 Pneumatic pressure massage device WO2021038444A1 (en)

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