CN107260241B

CN107260241B - Wound negative pressure involution device

Info

Publication number: CN107260241B
Application number: CN201610715802.XA
Authority: CN
Inventors: 张传忠
Original assignee: Zhejiang Haichuang Medical Device Co ltd
Current assignee: Zhejiang Haichuang Medical Device Co ltd
Priority date: 2016-04-07
Filing date: 2016-08-18
Publication date: 2020-06-23
Anticipated expiration: 2036-08-18
Also published as: CN107260241A

Abstract

This patent relates to a surgical medical device for apposing skin wounds and draining exudates using negative pressure suction. The wound protection device comprises an open container which can form a closed cavity through the closed combination of an annular opening edge and surface tissues around a wound, and when negative pressure is formed in the open container under the action of external factors, the surface tissues on two side edges of the wound can be mutually opposite and can be kept through the deformation of the open container. The device solves the problem that the existing wound closing device can not provide automatically-adjusted and dynamically-adapted skin tissue apposition pressure in the wound healing process, and can remove possibly more blood or tissue exudation in the initial stage of wound healing in time.

Description

Wound negative pressure involution device

Technical Field

The patent relates to a surgical medical instrument for apposing skin wounds and helping to drain exudates in the wounds by using negative pressure suction.

Background

Conventional wound closure means are surgical sutures, and convenient and quick suturing devices replacing surgical sutures include various wound clips and staples such as US4535772, and wound zippers and similar devices having convenient, quick and minimally invasive features are being increasingly used, such as US3516409 and US2013/0066365a 1. Some wound closure devices also incorporate closure pressure regulating structures such as US2004/0267309, CN104023648A and CN 104755033A.

Except for the factors of physique and local tissue injury which influence the healing speed of skin wounds and the scar formation degree when using the zipper type wound closing device, the size of the skin edge involution pressure and the retention of foreign matters in the wounds are the most important matters. The wound foreign body includes residual blood and excess exudate. Compared with the traditional suture dressing mode, the zipper type wound closing device has the defect of absorption of local exudation due to the inconvenience of placing a large-volume adsorption dressing in the closing device. Because traumatic inflammation with different wound degrees has a process from generation to regression and the requirement on the pressure is a dynamic change process, the existing suture mode and the wound closing device can not provide the involution pressure for automatically adjusting the dynamic adaptation. When inflammation is obvious, the local blood supply is affected by overlarge pressure applied to the local part, and when the inflammation is subsided, the pressure is reduced, so that involution gaps are easy to generate.

Disclosure of Invention

The invention discloses a wound closing device which utilizes a negative pressure suction closing device covered on a wound to simultaneously solve the two problems of the discharge of wound exudates and the dynamic adjustment of closing pressure.

The specific technical scheme is as follows: a wound closing device comprises an elastic open container which can form a closed cavity through the closed combination of an annular opening edge and surface tissues around a wound, and is characterized in that when the open container forms negative pressure under the action of external factors, the surface tissues on the edges of two sides of the wound can be mutually opposite and kept in an involutive state through the deformation of the open container. The negative pressure at the wound site itself may also facilitate the timely drainage of exudate from the wound site. The wound includes surgical incision and wound. The surface tissue around the wound includes the surface tissue of the skin, mucosa or organs in the body, and the term "skin" or "skin tissue" is also used to refer to the surface tissue around the wound, unless otherwise specified. The external factors include the suction of air in the container and the pressing of the container to cause the container to elastically deform. Said closed cavity is also called suction cavity. The suction chamber may be kept at a negative pressure for a long time by using a highly elastic material and increasing the volume of the suction chamber in some form, for example, by providing a large cavity such as a mushroom head at the top of the open container. An outward one-way valve may also be provided on the suction chamber side wall for manually venting possible leakage air before the negative pressure is reduced to a detrimental extent.

In view of facilitating partial dressing of a wound, the wound closure device may be specifically configured to: the skin-care device comprises a first connecting belt capable of being firmly and airtightly combined with first wound margin skin, a second connecting belt capable of being firmly and airtightly combined with second wound margin skin and a supporting belt for connecting the first connecting belt and the second connecting belt, wherein the 3 parts are airtightly connected and jointly enclose an elongated cavity with one open surface, namely a suction cavity. The two ends of the first connecting belt and the second connecting belt are connected, and the free edges of the first connecting belt and the second connecting belt form an annular opening edge of an open cavity wall. A suction port for communicating a suction device such as a negative pressure bottle is provided on the wall of the suction chamber. When the suction cavity is in a negative pressure state, the middle parts of the free edges of the first connecting belt and the second connecting belt can be close to each other under the action of atmospheric pressure, so that the skin of the first wound edge and the skin of the second wound edge tend to be tightly combined with each other. Wounds here include surgical incisions and traumatic wounds. And is generally more suitable for wounds in which deep tissue has been sutured or which are inherently shallow without deep sutures. The first and second wound margins are referred to herein as the margins on either side of the wound. Here, the lateral direction refers to a direction parallel to the skin surface and perpendicular to the wound direction, and the longitudinal direction refers to the same direction as the wound direction. The wound may be a straight line or a curved line. As used herein, "soft" is medically customary, and the hardness of "hard" is generally referred to the lips of a person, and the hardness of "hard" is generally referred to the forehead or nails of a person.

The wound closing device can adopt medical silicon rubber or soft medical plastics, the free edges of the first connecting belt and the second connecting belt are provided with soft strip-shaped sucker structures parallel to the edges, and the supporting belt can adopt an arch structure which can keep the shape and protrudes into the cavity in a negative pressure state. A thin hinge-like structure is provided at the traveling position of the connecting belt and the supporting belt.

The wound closing device can be formed by a soft sealing structure and a hard supporting structure, the soft sealing structure forms the complete wall of the suction cavity device, the supporting structure totally covers the outer surfaces of the supporting belt and the parts of the supporting belt except the sucking discs at the two connecting belts and is tightly connected with the sealing structure, and a hinge structure is arranged at the moving part of the connecting belts and the supporting belt of the supporting structure. The overall coverage is based on the support structure not necessarily being a continuous curved surface, there may be uncovered bare gaps.

In order to enable the wound closure device to accommodate curved wounds in various spatial directions and deformed wounds at a mobile joint, the support structure may be provided as a series of transverse, narrow strip-like structures which are themselves only partially connected or not connected at all.

The transverse cross-section of the wound closure device can be arranged in an 'M' shape by taking the connecting belt into consideration to keep larger wound skin closing force and prevent the wound skin edge from being excessively everted.

In order to reduce the tension of the skin at the wound margin and avoid the wound from being subjected to accidental acting force exceeding the maximum bearing range of the negative pressure acting force, so that the absorption action is lost to cause the rupture of the wound which is not completely healed, a fastening tension-reducing device which can keep the skin at the two sides of the wound in a tension-free state can be arranged on the outer sides of the first connecting belt and the second connecting belt.

The fastening tension-reducing device can adopt an O-shaped plastic hard fixing device, wherein the plastic hard fixing device can adopt a plaster bandage, a resin bandage or a low-temperature thermoplastic plate. The above materials are commonly used for shaping and fixing in orthopedics and orthopedics department. The attachment of the fastening and tensioning device to the skin may be made using the same adhesive materials, such as hydrogels, as are currently used for wound closure devices.

The O-shaped plastic hard fixing device can be used alone in combination with a skin adhesive material to achieve the effects of skin tension reduction and skin edge accurate involution, and can be used for closing short and shallow wounds with small damage and less exudation.

Alternatively, the fastening and tensioning device may be configured to add a first adhesive tape and a second adhesive tape to the outside of the first and second attachment tapes, respectively, which are securely adhered to the skin, and to provide an adjustable length pulling device, such as a lace, a buckle, or a screw, between the first and second adhesive tapes across the suction chamber.

In order to observe the placement position of the wound closure device and observe the wound closure apposition after the negative pressure suction is started, a transparent observation belt can be arranged in the middle of the supporting belt.

To reduce the wound exudate from soaking the wound margins, a porous material, such as a polymeric open-cell foam or sponge, may be disposed within the aspiration chamber.

In order to form a moist and antibacterial healing interface on the wound, medical honey liquid or other medical liquid beneficial to wound healing can be filled in the porous material.

Some porous materials also become relatively transparent after being sufficiently wetted with a transparent liquid.

In order to maintain the necessary concentration and freshness of medical fluid such as honey in the case where the initial wound is oozed out, a suction port may be provided at one end of a suction chamber, and an injection port which can communicate with a medical fluid injection device such as an automatic microinjection device may be provided at the other end of the suction chamber.

The invention is further described with reference to the following figures and specific embodiments.

Drawings

Fig. 1 is a perspective view of a negative pressure wound closure device in its prototype, the device being turned upside down.

Fig. 2 is a perspective view of a negative pressure wound closure device in phantom, covering a wound.

Fig. 3 is a schematic perspective view of a flat, elongated, uniform material negative pressure wound closure device.

Fig. 4 is a longitudinal cut-away perspective view of the negative pressure wound closure device of fig. 3.

Fig. 5 is a schematic cross-sectional perspective view of the negative pressure wound closure device of fig. 3.

Fig. 6 is a schematic cross-sectional view of the negative pressure wound closure device of fig. 3.

Fig. 7 is a schematic perspective view of a negative pressure wound closure device with a narrow band support structure and an "O" shaped malleable rigid fixture.

Fig. 8 is a longitudinal cut-away perspective view of the negative pressure wound closure device of fig. 7.

Fig. 9 and 8 are partially enlarged.

Fig. 10 is a schematic cross-sectional perspective view of the negative pressure wound closure device of fig. 7.

Fig. 11 is a partial enlargement of the cross section of the "M" shape in fig. 10.

Fig. 12 is a schematic perspective view of the negative pressure wound closure device of fig. 7 applied to a curved wound.

Fig. 13 is a schematic perspective view of a negative pressure wound closure device with an adhesive tape fastening and tensioning device.

Fig. 14 is a longitudinal cut-away perspective view of the negative pressure wound closure device of fig. 13.

Fig. 15 is a partial enlargement of fig. 14.

Fig. 16 is a schematic cross-sectional perspective view of the negative pressure wound closure device of fig. 13.

Fig. 17 is a schematic cross-sectional view of the negative pressure wound closure device of fig. 13 with the tension relief device secured.

Fig. 18 is a partial enlargement of fig. 17.

Fig. 19A-19f schematic diagrams of the clinical use procedure of the negative pressure wound closure device.

Detailed description of the invention

Example 1

A negative pressure wound closure device prototype, see figures 1-2.

The wound closing device is an open container 01 which is made of silicon rubber or elastic plastic materials, an annular sucker 0111 is arranged at the position of an annular opening edge 011, and the annular opening edge 011 of the open container 01 can be combined with the surrounding surface tissues of the wound in a closed mode to form a closed cavity. When the open container is extruded by external force to generate elastic deformation, the pressure is removed, negative pressure is formed in the closed cavity, and the deformation of the open container under the action of the negative pressure can enable surface tissues at the edges of two sides of the wound to be mutually opposite and keep an involutive state.

Example 2

Flat, elongated, uniform material negative pressure wound closure device, see figures 3-6.

To facilitate dressing and to ensure intraluminal negative pressure, the wound closure device may be provided in a flat elongated shape and connected to a negative pressure suction source, such as a negative pressure bottle or central negative pressure conduit.

The specific scheme is as follows: the suction chamber 110 is enclosed by 3 parts of the first connecting belt 111, the second connecting belt 112 and the support belt 113 which are connected in a sealing way, and one end of the suction chamber 110 is provided with a suction port 114 communicated with the suction port. The suction port 114 may communicate with a suction device (not shown). The wound closing device adopts medical silicon rubber or soft medical plastic with certain supporting force, and a soft strip sucker structure 115 parallel to the edge is arranged on the annular edge formed by respectively connecting the two ends of the first connecting belt and the second connecting belt. A thin hinge-like structure 116 is provided at the transition of the first and second connecting

bands

111, 112 and the support band 113.

When the suction cavity is in a negative pressure state, the free edge of the first connecting belt 111 and the free edge of the second connecting belt 112 can be close to each other under the action of atmospheric pressure, so that the skins of the first wound edge and the second wound edge tend to be closely opposite to each other and keep an involution state.

Example 3

Negative pressure wound closure device with narrow band support structure and "O" shaped shapeable rigid fixation means, see fig. 7-12.

An improvement is made on the basis of the embodiment 2.

The device is composed of a sealing structure 21 and a supporting structure 22. The support structure 22 covers the support tape 213, the first connection tape 211, and the second connection tape 212 except for the suction cups 215 and is tightly coupled with the sealing structure.

The sealing structure 21 is a thin shell-like open container with approximately the same thickness except at the suction cup 215, and is tightly connected with the supporting structure 22 covering the outer layer, and can be made of silicon rubber or elastic soft plastic.

The support structure is provided as a series of transverse, narrow strip-like structures 221 that are either partially attached themselves (as in fig. 7-11) or not attached at all (as in fig. 12). Hinge structures 225 are provided at the support structures at the locations where the

connection bands

211, 212 and the support band 213 travel, respectively. The support structure may be made of a rigid flexible plastic.

The wound closure device includes a sealing structure 21 and a support structure 22 arranged in an "M" shape in transverse cross-section and with the recessed portion arranged to be transparent, including a sealing structure transparent strip 218 and a support structure transparent strip 228.

The suction port 214 is provided at one end of the suction chamber, and an injection port 217 for communicating with a medical liquid injection device such as an automatic micro-injection device (not shown) is provided at the other end of the suction chamber.

An O-shaped fastening tension-reducing device 23 which can keep the skin on both sides of the wound in a tension-free state is arranged on the outer side and two ends of the first connecting belt and the second connecting belt. The tension reducing device can be made of plastic hard materials, and can be a plaster bandage, a resin bandage or a low-temperature thermoplastic plate, preferably a low-temperature thermoplastic plate. The fastening and tensioning device 23 may be attached to the skin using the same adhesive material, such as hydrogel, as is currently used for wound non-invasive closure devices.

The steps of use and the principle of action of the device can be seen in fig. 19A-19E. Wherein 19A shows a wound before suturing, 19B shows a wound completing deep and subcutaneous layer suturing, 19C shows a wound to which an O-shaped shapeable hard fixing device is attached, 19D shows a wound on which a negative pressure wound closing device main body is placed, 19E shows that a negative pressure has been established by the negative pressure wound closing device, wound edges are perfectly aligned and slightly everted, and 19F shows that honey 24 has been injected into the suction cavity.

Example 4

A negative pressure wound closure device with an adhesive tape and a fastening tension relief device.

Some changes were made on the basis of example 3. The O-shaped fastening tension-reducing devices 23 which are arranged at the outer sides and two ends of the first connecting belt and the second connecting belt and can keep the skin at two sides of the wound in a tension-free state are replaced by the adhesive belts and the strong traction devices.

The technical scheme is as follows: a first adhesive tape 331 and a second adhesive tape 332 are added to the outer sides of the first connecting tape 311 and the second connecting tape 312, and a rack 333 and a catch 334 whose length can be adjusted are provided between the two adhesive tapes across the suction chamber. The rack 333 and the locker 334 are fixedly coupled with the first adhesive tape 331 and the second adhesive tape 332, respectively. Corresponding indentations are provided in the seal 31 and support 32 at locations corresponding to the positions spanned by the racks.

The first adhesive strip and the second adhesive strip may be adhered to the skin using the same adhesive material as currently used wound non-invasive closure devices.

The technical scheme and the specific embodiment of the invention represent the following technical progress and beneficial effects relative to the prior wound closing device:

solves the problem that the existing wound closing device can not provide the skin tissue involution pressure in the wound healing process with automatic adjustment and dynamic adaptation.

Possibly more blood or tissue exudation in the early wound healing period can be removed in time.

Under the condition that the wound skin has larger tension, the wound skin can be ensured to be accurately and uniformly jointed, the local blood supply is sufficient, and the reliability of jointing and fixing can be ensured.

Can adapt to the involution of a bending wound and a moving wound positioned at a movable joint part.

Medical liquid such as honey can be applied to the local part of the wound, so that the healing speed of the wound is accelerated, and the scar formation is reduced.

The wound healing condition can be observed conveniently without opening the dressing.

In the case of unintentional infection, it can be achieved that the dressing need not be replaced throughout the healing process of the wound.

Claims

1. A wound closing device comprises an elastic open container which can form a closed cavity by the airtight combination of an annular opening edge and surface tissues around a wound, and is characterized in that the open container comprises a first connecting belt which can be firmly and airtightly combined with first wound margin skin, a second connecting belt which can be firmly and airtightly combined with second wound margin skin, and a supporting belt which is connected between the first connecting belt and the second connecting belt, wherein the 3 parts are airtightly connected and jointly enclose a long and narrow cavity with one open surface, namely an attraction cavity; the open container is arranged to be composed of a soft sealing structure and a hard supporting structure, the soft sealing structure forms the complete wall of the open container, the supporting structure covers the outer surface of the open container except the sucker and is tightly connected with the sealing structure, and a hinge structure is arranged at the moving position of the connecting belt and the supporting belt of the supporting structure; when the open container forms negative pressure under the action of external factors, surface tissues on the two side edges of the wound can be mutually opposite and kept in an involution state through the deformation of the open container; the wound comprises a surgical incision and a wound; the first wound edge and the second wound edge refer to skin edges on two sides of the wound; the surface tissue around the wound comprises the surface of skin, mucosa or organs in vivo; the external factors include the suction of air into the closed cavity and the elastic deformation of the open container by squeezing.

2. The wound closure device of claim 1, wherein the support structure is a series of transverse straps which may or may not be partially connected to themselves.

3. The wound closure device of claim 1, wherein the open container is configured in an "M" shape in transverse cross-section.

4. A wound closure device as claimed in claim 1, in which a fastening and tension reducing means is provided on the outer side of the first and second straps to maintain the skin on either side of the wound in a tension-free condition.

5. The wound closure device of claim 4, wherein the fastening and tensioning means comprises an O-shaped malleable rigid fixation device on the outside of the first and second straps and at each end thereof capable of adhering to the tissue of the periwound surface.

6. The wound closure device of claim 4, wherein the fastening and tensioning means comprises first and second adhesive strips disposed on the outside of the first and second connector strips for adhering to the tissue of the periwound surface, and adjustable length pulling means is disposed across the open container between the first and second adhesive strips.

7. A wound closure device as claimed in claim 1, in which the wall of the aspiration chamber is provided at one end with an aspiration port communicating with the aspiration means and at the other end with an injection port capable of communicating with a medical fluid injection means.

8. The wound closure device of claim 1, wherein a transparent viewing strip is provided intermediate the support strips.