WO2008101243A2 - Laser surgical device and methods of use - Google Patents

Laser surgical device and methods of use Download PDF

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Publication number
WO2008101243A2
WO2008101243A2 PCT/US2008/054258 US2008054258W WO2008101243A2 WO 2008101243 A2 WO2008101243 A2 WO 2008101243A2 US 2008054258 W US2008054258 W US 2008054258W WO 2008101243 A2 WO2008101243 A2 WO 2008101243A2
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WIPO (PCT)
Prior art keywords
laser
tissue
laser energy
excision
surgery system
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PCT/US2008/054258
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French (fr)
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WO2008101243A3 (en
Inventor
Joseph Giovannoli
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Joseph Giovannoli
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Publication of WO2008101243A2 publication Critical patent/WO2008101243A2/en
Publication of WO2008101243A3 publication Critical patent/WO2008101243A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/203Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser applying laser energy to the outside of the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00005Cooling or heating of the probe or tissue immediately surrounding the probe
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00452Skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B2018/2015Miscellaneous features
    • A61B2018/202Laser enclosed in a hand-piece
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B2018/2205Characteristics of fibres
    • A61B2018/2211Plurality of fibres

Abstract

The present invention is directed to techniques in the field of surgical systems, devices, and methods of use for skin reduction, tightening, or excision, and more particularly, to methods, systems, and devices for removing skin in tissue reduction laser surgery for the removal of skin wrinkles, laxities, or the like with minimal scarring after healing. The systems, devices, and methods of the present invention are adapted to control laser light energy to irradiate tissue such that the laser reduces, such as through vaporization, tissue in laser surgery. The present systems are adapted to use at least one laser device in conjunction with conventional and novel excision array shaping means, fiber optic light guides, distribution cylinders, stepping motors, computer programs, surgical techniques or the like therefor.

Description

LASER SURGICAL DEVICE AND METHODS OF USE
FIELD OF THE INVENTION
The present invention is directed to techniques in the field of surgical systems, devices, and methods of use for skin or other tissue reduction, tightening, or excision, and more particularly, to methods, systems, and devices for removing skin or other tissue in tissue reduction laser surgery for the removal of skin wrinkles, laxities, or the like with minimal scarring after healing. The systems, devices, and methods of the present invention are adapted to control laser light energy to irradiate tissue such that the laser reduces, such as through vaporization, tissue in laser surgery. The present systems and methods are adapted to use at least one laser device in conjunction with conventional and novel excision array shaping means, fiber optic light guides, distribution cylinders, stepping motors, computer programs, surgical techniques or the like therefor.
Additionally, while the techniques described herein are so described primarily for operation on skin, they may be extended to other types of tissue in a straightforward manner.
BACKGROUND OF THE INVENTION
A number of methods have been used to tighten skin for the purpose of restoring a more youthful appearance. Several methods well known in the art are dermabrasion, laser resurfacing and chemical peels. In using these facial resurfacing processes, the epidermis is denuded to a certain depth by direct physical, chemical or thermal injury applied to the skin. The cutaneous injury induces a healing response, resulting in the deposition of a new skin matrix with improved appearance. Skin rejuvenation occurs by a proliferation of fibroblast activity, the action of inflammatory mediators, and a deposition of new collagen and other dermal matrix proteins. The object of these methods is to create a smoother and more attractive epidermal layer.
Using a different principal, Di Matteo (U.S. Pat. No. 3,911,909) discloses a device that applies pressure to the interior surface of the mouth and the adjacent exterior surface of the face for the purpose of mechanically flattening facial wrinkles. In a method described by Hofmann (U.S. Pat. No. 3,949,741), pressure-sensitive adhesive film is applied to the skin, left for a few hours, and stripped off, removing with it a layer of dead epidermal cells. A number of patents describe various means by which collagen in the skin is caused to contract by heating with lasers or electromagnetic radiation. These processes create collagen scarring below the skin surface, which tightens the skin at the treated site. U.S. Patent No. 6,241,753 describes a method by using electromagnetic radiation and U.S. Patent No. 5,370,642 describes a method using laser energy.
A noninvasive surgical method for tightening the skin is described in McAllister (U.S. Pat. No. 5,713,375) wherein a skin scratching tool with a plurality of generally parallel cutting blades is applied to the skin. The resulting parallel "scratches" in the skin heal and thereby cause the skin to tighten. Another method involves subcutaneous implanting of gold threads. The threads are implanted in sub-dermal space at the level of the derma inner edge and are aligned along and/or across wrinkles and skin folds. This method is said to induce collagen formation.
Within the category of surgery, it is generally known that plastic surgeons perform face-lifts and other types of rhytidectomies to tighten skin on the face, arms and other parts of the body. In a face- lift procedure, the surgeon begins an incision in the area of the temple hair, just above and in front of the ear, and then continues around the lobe, circling the ear before returning to the point of origin in the scalp. The skin is raised outward before the surgeon repositions and tightens the underlying muscle and connective tissue. Some fat may be removed, as well as excess skin. For men, the incision is aligned to accommodate the natural beard lines. In all cases, the incision is placed where it will fall in a natural crease of the skin for camouflage. One drawback resulting from placing an incision remote from the specific area of laxity is that the surgery stretches more skin than is necessary to reduce skin laxity or to reduce wrinkles. Such stretching reduces skin thickness and limits the number of times such procedures can be repeated. In addition, large scale pulling of the skin toward the hairlines can, in some cases, give the face an artificial look considered by many to be characteristic of apparent or repeated face-lifts. In addition, such procedures do not always resolve wrinkling in the mouth and chin areas. Moreover, such procedures do not lend themselves to resolving problems in other small areas of the body such as wrinkling at the junction of the thumb and forefinger . In conventional skin treatment surgical practice, surgeons typically use a scalpel to remove skin abnormalities such as lesions or tumors. This is different from diagnostic skin sampling wherein biopsy punches are used to reduce reliance on the personal skill of the medical doctor. Such diagnostic punches are disclosed by Gibbs (US Patent No. 3,990,451) and Yeh et al . (US Patent No. 5,183,053). To avoid the unpleasant "dog ears" that may result from a circular or oval -shaped incision, for example, surgeons usually make a navicular- shaped incision (boat-shaped) , around the lesion or tumor. However, these skin treatment techniques may not result in a satisfying aesthetic appearance if applied to the practice of cosmetic surgery since a single incision to reduce skin area for removing wrinkles or laxities may result in noticeable scarring after healing. Therefore, there exists a need for an improved means for performing surgical skin reduction, such as in rhytidectomies operations, which addresses the inherent limitations resulting from the need to avoid creating obvious scars and the resulting unfortunate stretching of more skin than would otherwise be involved in skin, laxity and wrinkle reduction.
Thus, it is an object of the present invention to provide a system, method and device whereby skin reduction is achieved with minimal or barely visible scarring and by treating skin proximate the wrinkle, laxity or reduction area to be treated.
SUMMARY OF THE INVENTION
The present invention uses a series of laser applications to remove tissue in a prescribed pattern to thereby cause a gradual tightening over the area of tissue to be reduced. The present invention is preferably adapted to be used in conjunction with the devices and methods disclosed in PCT Patent Application No. PCT/US2007/073459, PCT Patent Publication No. WO 2005/072181 A2 , United States Patent Publication No. US/2007/0068537 Al, United States Patent Publication No. US/2005/0283141 Al, and United States Patent Publication No. US/2007/0073327 Al, which are incorporated by reference herein in their entirety. The present invention is adapted to be used alone or in combination with other conventional and novel surgical methods and devices as well. The advantages of this invention are best understood after reading the detailed description. Nonetheless, some of the advantages are aforementioned above.
Other aspects, features, advantages, etc. will become apparent to one skilled in the art when the description of the invention herein is taken in conjunction with the accompanying drawings . BRIEF DESCRIPTION OF THE DRAWINGS
For the purposes of illustrating the various aspects of the invention, wherein like numerals indicate like elements, there are shown in the drawings simplified forms that may be employed, it being understood, however, that the invention is not limited by or to the precise arrangements and instrumentalities shown, but rather only by the claims. The drawings may not be to scale, and the aspects of the drawings may not be to scale relative to each other. Figs. Ia and Ib schematically illustrate an embodiment according to the present invention in which a plurality of incisions are made for excising a patch of skin, before and after closure of the incisions respectively.
Fig. Ic illustrates that the plurality of navicular incisions in Figs. Ia and Ib are arranged according to the "area rule" to collectively form a generally diamond- shaped or navicular shaped patch of skin to be treated.
Fig. 2 illustrates another embodiment according to the present invention in which a plurality of navicular incisions are arranged according to the "area rule" to collectively form a navicular patch of skin to be treated.
Fig. 3 illustrates a further embodiment according to the present invention in which a plurality of differently shaped incisions are arranged according to the "area rule" to collectively form an elliptical patch of skin to be treated.
Fig. 4 is a perspective view of a laser surgery system in accordance with at least one aspect of the present invention.
Fig. 5 is a perspective view of a laser device in accordance with at least one aspect of the present invention. Fig. 6 is an overhead view of an excision array shaping means in accordance with at least one embodiment of the present invention . Fig. 7 is an overhead view of an excision array pattern produced by a computer pattern generator in accordance with at least one embodiment of the present invention.
Fig. 8 illustrates an embodiment in which the skin is treated using a laser.
DETAILED DESCRIPTION OF THE PRESENT INVENTION
In the following description, for purposes of explanation, specific numbers, materials and configurations are set forth in order to provide a thorough understanding of the invention. It will be apparent, however, to one having ordinary skill in the art that the invention may be practiced without these specific details. In some instances, well-known features may be omitted or simplified so as not to obscure the present invention. Furthermore, reference in the specification to "one embodiment" or "an embodiment" means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the invention. The appearances of the phrase "in one embodiment" in various places in the specification are not necessarily all referring to the same embodiment .
Fig. Ia is a plan view representation of a circular section 11 of skin with parallel prereduction orientation lines 12 and an array of excised navicular incisions 13 of skin prior to closure. The array of incisions 13 of skin collectively form a patch 14 that is to be tightened or treated. Fig. Ib is a plan view representation of the circular section 11 shown in Fig. Ia after closure of the incisions 13 of skin. The closures of incisions 13 are shown as short lines 13' in Fig. Ib, which are usually unnoticeable when the incisions 13 are very small.
Preferably, according to the teaching of the present invention, the array of incisions 13 are arranged according to an "area rule" wherein the total area of incision segments taken in a direction perpendicular to an axis 15 of the patch 14 changes gradually along the axis 15. It is understood that such gradual changes include incremental increases, stasis (if any) and incremental decreases. Preferably, no discontinuity exists in the change.
The "area rule" is now explained in more detail with reference to Fig. Ic, which is a plan view of the array of incisions shown in Figs. Ia and Ib with an associated relative area graphical representation that represents a total area of incision segments along an axis "X" of the skin patch 14. The total areas and corresponding incision segments at three positions Pl, P2 and P3 along the axis "X" are exemplarily shown. Specifically, total area Al at position Pl is a sum of areas of incision segments 16a and 16b which are taken at the position Pl in a direction perpendicular to the axis "X" . All the segments are considered to have the same width, which is a predetermined length of the axis "X" . Similarly, total area A2 is a sum of areas of incision segments 17a, 17b and 17c taken at the position P2 , and total area A3 is the area of the incision segment 18 taken at the position P3. According to the "area rule", the total area of the incision segments taken in a direction perpendicular to the axis "X" changes gradually along the axis "X", as illustrated in the area graphical representation in Fig. Ic. In other words, the collective incision area change along the axis "X" of the incision array maintains a gradual and continuous increase, stasis (if any) and decrease in collective incision area perpendicular to the axis "X", preferably without discontinuities in incremental area change. Since all the segments have the same width, the "area rule" may also be interpreted as that the sum of the heights of all the segments corresponding to a point on the axis "X" changes gradually along the axis "X" .
Observing this "area rule" when designing surgical incision arrays will provide a continuous and balanced tightening of skin on closing the array incisions, equivalent to having performed one large area rule incision such as in a single elliptical or navicular incision performed by a scalpel or a biopsy punch, but without one large noticeable scar. The closed incisions 13 collectively pull the skin on either side of the axis "X" of the reduced patch in a gradual and uniform manner as if in a single large navicular incision. The scar pattern in Fig. Ib demonstrates this concept.
Preferably, the axis "X" of the skin patch 14 that is to be reduced is oriented parallel to the lines of least skin tension of the skin patch 14, such as lines perpendicular to the long axis of an arm.
The skin patch 14 to be treated or reduced, which is collectively formed by the plurality of incisions 13 arranged following the "area rule", may be of a navicular shape (Fig. 2) , an elliptical shape (Fig. 3) , a circular shape, a rectangular or elongated shape (such in a scalp reduction) or other proper shapes. The incisions 13 are preferably of navicular shape to avoid "dog ears" , and can be either identical (Fig. 2) or different (Fig. 3) . Fig. 2 illustrates an embodiment in which a navicular skin patch 14 is collectively formed by a plurality of identical navicular incisions 13. The incisions 13 are arranged according to the "area rule" as explained above, and the total area of incision segments gradually increases and decreases along the axis "X" which extends through the two ends of the navicular skin patch 14, as illustrated in the area graphical representation. For example, a total area Al at position Pl represents the sum of areas of the incision segments 16a, 16b and 16c taken at the position Pl in a direction perpendicular to the axis "X" .
Fig. 3 illustrates an embodiment in which an elliptical- shape skin patch 14 is collectively formed by a plurality of different navicular-like shaped incisions 13. Although the incisions 13 are different, the total area of incision segments still follow the "area rule" as shown in the area graphical representation in Fig. 3. This can be done by properly selecting the dimensions, shapes and locations of the incisions 13. Preferably, computer software can be written to assist in determining the size, shape and placement of the incisions 13 for a given skin patch 14 to be reduced. It is noted that exemplary total areas Al and A2 at two positions Pl, P2 and their associated incision segments 16a, 16b, 16c and 17 are illustrated in Fig. 3. To make scar patterns less noticeable, the axes of the incisions 13 which extend across the two ends of the navicular shapes may be arranged more or less randomly unparallel to the axis "X" of the skin patch 14. In choosing the degree of variation from the axis "X", the area rule is preferably followed since the incisions 13 will be closed by moving skin on the lateral sides of the array substantially perpendicular to and toward the axis "X" . For arrays that require curved axes, e.g., extremely long arrays relative to their width, the axis "X" can curve to conform to skin reduction requirements and lines of least skin tension. An example of a curved array that would not be considered long is an overall circular array with incision axes that form a curve to conform to wrinkle areas around the mouth or eyes .
In accordance with the aforementioned, systems, methods, and devices are disclosed herein for reducing, tightening, or excising tissue in laser surgery. Preferably, the method of the present invention is carried out with at least a laser surgery system. While the following description shows different embodiments that may be employed in a laser surgery system, those skilled in the art will recognize that many types of laser devices and methods may be used with the embodiments described herein.
Now referring to FIG. 4, a laser surgery system 20 includes a laser device 22, a columnator 24, and an excision array means, such as, but not limited to, an excision array mask 26 or the like. In accordance with at least one embodiment, laser energy is directed to a columnator 24, which delivers parallel beams of laser energy to an excision array means, such as mask 26, situated either before or after the columnator and between the laser device 22, which is the source of the laser energy, and the tissue to be excised 28. As the mask 26 blocks a portion of the columnated laser energy, the unblocked laser energy passes through holes 25 of a predetermined pattern 29 of mask 26 and ablates tissue portions 28 of tissue surface 27 in the predetermined pattern 29 of the mask 26.
In at least one embodiment, a combination of the columnator 24 producing the columnated laser energy and an excision array means, such as mask 26, is arranged within a hand held device or hand piece (see reference 34 of Fig. 5) .
Now referring to Fig. 5, the hand held device or hand piece 34 is arranged to be positioned against the tissue 39 being treated, e.g., with a cooled sapphire wafer. In some embodiments, the hand held device or hand piece 34 is arranged to be positioned away from the tissue 39 being treated by suitable standoff wire, plastic, or other arrangements which attach firmly to the hand held device 34 and contact the tissue 39 away from the area being ablated. In the event a direct skin contact device is not used, the purpose of such standoff arrangements is to ensure that the orientation of the laser energy emanating from the hand held device or hand piece 34 does not move relative to the tissue 39 being ablated during the procedure. Misregistration during the ablation process would alter the predetermined excision pattern 37 being sought.
As illustrated in Fig. 5, a laser device includes a laser energy source 31, a distribution device, such as, but not limited to, distribution cylinder 32, a fiber optic guide 35, and an excision array shaping means 70. The laser energy source generates laser energy through a distribution device, such as distribution cylinder 32. In at least one embodiment, the distribution device is adapted to rotate, and a stepping motor can rotate the distribution cylinder 32 in direction 33. In various embodiments, the laser light can be distributed by one or more fibers that move so that their energy is sequentially delivered to one or more openings over an area to be treated, or a full set of fibers, one for each opening, can be used, so that no movement of the fiber delivering the laser energy is needed. Or, a combination of the foregoing can be used.
Fiber optic light guide 35 includes an optical fiber, at least one fiber optic element 36, or bundled optical fiber elements and is adapted to guide the laser energy to the excision array shaping means 70. The number, diameters and cross-sectional shapes of fibers bundled in the various possible embodiments may vary. At the end of the light guide 35 the fiber optic elements 36 are separated into a plurality of, e.g., navicularly shaped fiber optic bundles, which together form an excision array shaping means (see reference 60 in Fig . 6) .
Now referring to Figs. 1-6, those skilled in the art will recognize that any type of excision array shaping means may be used, such as an excision array mask 26 or 60, a columnator 24, a distribution device, such as a distribution cylinder 32, optic fiber bundles 61, a computer pattern generator, or the like.
As illustrated in Fig. 6, the excision array shaping means includes bundles 61 of fiber optic elements 36. In at least one embodiment shown in Figs. 5-6, each of the 1 mm x 2 mm navicular shaped fiber optic bundles is made up of, e.g., circular fiber optic elements 36 of approximately 100 microns diameter. This arrangement distributes columnated laser energy to the skin in a predetermined excision pattern 37. The tip of each optical fiber is polished to form an end face that is perpendicular to its longitudinal axis so that a beam of laser energy passing through it is emitted axially from each fiber end face. In the event laser energy is provided to all optical fibers contemporaneously, the energy from adjacent fibers merges into a single shaped beam, e.g., in a substantially simultaneous process. The glass fibers are held together by a suitable bonding material, such as, but not limited to, a 353 ND Epoxy, or the like. Alternatively, a lower power laser can be used if the individual optical fiber bundles or parts thereof are independently exposed to laser energy, e.g., in a sequential process. Additionally, combinations of the foregoing may be used.
Again referring to Fig. 5, the excision array shaping means 70 guides the laser energy, such as, but not limited to, laser pulses 38, or the like, to a designated area of tissue surface 39. The excision array shaping means 70 is adapted to guide laser energy, such as laser pulses 38, to a tissue surface 39 over a designated area to reduce and/or excise at least one of a plurality of tissue portions 71 in a predetermined pattern, such as, but not limited to, excision array 37, or the like.
In at least one embodiment, applying laser energy in one or a few bursts over the entire excision array mask 26 requires a powerful laser and might cause collateral tissue to be damaged from the thermal buildup. Now referring to Fig. 7, a laser of relatively low power is employed with the use of an excision array means, such as a computer pattern generator, for the prevention of collateral tissue damage. Those skilled in the art will recognize that any type of computer pattern generator may be used in tandem with the present method and laser surgery system 20 or laser device 30, such as, but not limited to, the device for producing a pattern of spots by scanning a laser as shown in United States Patent No. 7,090,670, or any other conventional and novel devices. A method of laser surgery for reducing tissue is employed with the use of the computer pattern generator and a laser device which generates laser energy, delivers the laser energy in parallel beams to an excision array shaping means with a columnator, and distributes the laser energy over the tissue being ablated during the procedure of a predetermined shape in a designated area of a tissue surface where the laser energy is distributed throughout the designated area in a manner aforementioned with respect to Figs. la-3. This method of employing a computer pattern generator allows rapid delivery of intense laser energy with controlled ablation positioning over a large treatment area. Individual pulsed ablation spots can be programmed such that the ablated spots can be spaced precisely to leave zones 42 between exposures 41. The zones 42 act as thermal dissipation volumes, thereby allowing the use of lower power, higher energy density lasers. Alternating the exposed treatment spots 41 on successive passes of the laser energy would provide thermal dissipation volumes or zones 42 and ensure complete excision with minimized thermal damage to collateral tissue. In addition to controlling heating and using a low power laser, this method allows easy selection of a variety of excision array pattern shapes, sizes, and densities, such as, but not limited to, programmed excision array pattern 40 or the like, without the use of physical masks. The laser focal spot can have, e.g., a square shape to avoid leaving interstitial tissue.
Generally, the use of a relatively small spot repeatedly within a specific navicular shape shown in Fig. 7 can be employed by first exposing the array of pixels shown as exemplary in Fig. 7, and then exposing the portions between the pixels in one or more passes of the relatively small cross sectional laser.
It is desirable to sense the temperature of collateral tissue to ensure that collateral tissue coagulation does not occur. Those skilled in the art will recognize that any type of cooling method may be used in tandem with the disclosed systems, devices, and methods. When regulating temperature, cooling methods, such as, but not limited to, employing cryogenics, may be used in configurations that can exceed tissue coagulation temperature.
As aforementioned, the skin reduction may be realized by laser treatment. Preferably, as illustrated in Figure 8, a mask 50 is provided to cover the patch of skin to be reduced by a laser 51. The mask 50, which is made of a material capable of preventing the laser 51 from passing through, has a plurality of holes 13' that allow the laser beam 51 to pass through. Each hole 13' exposes a region of skin to the laser 51 to be reduced by the laser 51. The laser 51 vaporizes the regions of skin exposed by the holes 13' on the mask 50. The duration of laser exposure should be sufficient to vaporize the dermal layer, but insufficient to vaporize sub-dermal tissue. More generally, the laser is preferably sufficient to remove whatever depth of tissue is desirable based upon the particular procedure being performed. Preferably, the holes 13' are dimensioned and arranged to follow the "area rule", i.e., a total area of all removed or treated skin segments taken in a direction perpendicular to an axis "X" of the patch with a predetermined width along the axis "X" varying gradually along said axis "X" . In a preferred embodiment, the holes 13' are navicular in shape.
Preferably, laser 51 may comprise one or more wide area beams each covering one or more of the holes 13'. Because of the protection of the mark 50, only the regions defined by the holes 13' are treated by the laser beams. Some or all of the wide area beams may stay statically above the relevant hole or holes 13', or may move around so that one wide area beam may treat different regions one after another . As an alternative, the laser 51 may comprise a single narrow beam that moves from one region to another in a predetermined pattern that is equivalent to the pattern of regions of skin exposed by the laser mask 50 described above. The beam can be turned off when it is moving, and turned on when it is moved to a desired position for treating a targeted region. Thus, the single beam may treat all the skin regions. In addition, the mask 50 may be omitted if the narrow beam has a cross-sectional shape that matches each region. In another embodiment, instead of treating navicular or elliptical regions of skin, the laser 51 may perform narrow line incisions, which may be measured in millimeters and smaller. In particular, the laser 51 may make multiple, substantially parallel narrow line excisions of same or different lengths, which collectively form the patch of skin to be treated. Compared to treating the patch with a single large incision, multiple small excisions reduce the appearance of scarring even without following the "area rule" . In addition, with narrow line excisions, the "dog ear" effect experienced with wider excisions would not be significant.
Preferably, the beginning and end areas of the line excision array may follow the gradual transition "area rule", while the substantially parallel and continuous portion of the excision array between the beginning and end areas would experience no combined excision area transition. Preferably, the narrow line excisions are spaced apart sufficiently.
When applied to excising tissue, it is necessary to control the depth as well as the pattern of laser cutting. Although Fitzpatrick scale of skin types can be used for a given laser to estimate penetration levels for different shades of skin color, an alternative would be to use the equivalent of an ultrasound scanner designed to measure skin thickness and subsurface structures. It is likely that cut depth testing with a scanning ultrasound device, such as those used to analyze decubitus ulcers, would be useful in determining the settings for excising tissue with a motion controlled narrow beam laser as well as testing the cut depth after each exposure of wide area lasers that can be used multiple times to excise tissue on all or part of a mask described above.
For purposes of the disclosure, the term excise is intended to cover removal of the tissue, whether by cutting or ablation.
Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims .

Claims

1. A laser surgery system for reducing tissue, comprising: an excision array shaping means,- a columnator; and a laser device adapted to operably generate laser energy, wherein the excision array shaping means and/or the laser device is adapted to guide laser energy to a tissue surface over a designated area to excise at least one of a plurality of tissue portions in a predetermined pattern, and wherein excised regions are closed after excising to facilitate tissue reduction.
2. The laser surgery system of claim 1, wherein the excision array shaping means and/or the laser device is adapted to operably control the laser energy to excise the at least one of a plurality of tissue portions.
3. The laser surgery system of claim 1, wherein the controlled laser energy is adapted to excise the at least one of a plurality of tissue portions in a predetermined pattern.
4. The laser surgery system of claim 1, wherein the tissue portions are substantially navicular in shape.
5. The laser surgery system of claim 1, wherein the excision array shaping means is adapted to operably distribute the tissue portions throughout the designated area in a manner to cause a substantially gradual increase and then decrease in total tissue removed along a cross section as said designated area is traversed along a line perpendicular to said cross section.
6. The method of claim 1, wherein at least two of the tissue portions are of similar shape and/or size to each other.
7. The laser surgery system of claim 1, wherein the controlled laser energy is adapted to excise the at least one of a plurality of tissue portions to a predetermined depth.
8. The laser surgery system of claim 1, wherein the excision array shaping means is adapted to distribute the laser energy to excise the at least one of a plurality of tissue portions in a predetermined pattern.
9. The laser surgery system of claim 1, wherein the at least one of a plurality of tissue portions is skin.
10. The laser surgery system of claim 1, wherein the excision array shaping means comprises at least one of: an excision array mask, a columnator, a distribution cylinder, optic fiber bundles, and a computer pattern generator.
11. The laser surgery system of claim 1, wherein the excision array shaping means comprises an excision array mask adapted to work in tandem with the columnator.
12. The laser surgery system of claim 1, wherein the excision array shaping means and the columnator are adapted to be arranged within a hand held device.
13. The laser surgery system of claim 12, further comprising a direct tissue contact device to ensure that the orientation of the laser energy emanating from the hand held or hand piece does not move relative to the tissue being ablated during the surgery.
14. The laser surgery system of claim 13, wherein the direct skin contact device is a cooled sapphire wafer.
15. The laser surgery system of claim 12, further comprising a standoff arrangement to ensure that the orientation of the laser energy emanating from the hand held device does not move relative to the tissue being ablated during the surgery when the hand held device is not in direct contact with the tissue.
16. The laser surgery system of claim 10, wherein the computer pattern generator is adapted to operably control ablation positioning over a predetermined treatment area.
17. The laser surgery system of claim 16, wherein the computer pattern generator is adapted to operably distribute laser energy over a plurality of tissue portions to leave at least one area of untreated tissue portions.
18. The laser surgery system of claim 17, wherein the at least one untreated tissue portion is of sufficient size to facilitate sufficient thermal dissipation to avoid overheating a surrounding area of tissue.
19. The laser surgery system of claim 17, wherein the computer pattern generator is adapted to alternate application of the laser energy between the at least one of a plurality of tissue portions on successive passes of the laser energy to provide at least one thermal dissipation volume and/or to ensure complete excision of tissue with reduced risk of thermal damage to collateral tissue.
20. The laser surgery system of claim 10, wherein the computer pattern generator is adapted to comprise programmed excision array patterns, shapes, sizes, and/or densities.
21. The laser surgery system of claim 20, wherein the computer pattern generator is adapted to operably distribute the laser energy without an excision array mask.
22. A method of laser surgery for reducing tissue, comprising: generating a laser energy with a laser device, delivering the laser energy in substantially parallel beams to an excision array shaping means with a columnator; and distributing the laser energy over at least a plurality of tissue portions of a predetermined shape in a designated area of a tissue surface with the use of the excision array shaping means, wherein the laser energy is distributed throughout the designated area in a manner to cause a substantially gradual increase and then decrease in total tissue removed along a cross section as the designated area is traversed along a line perpendicular to said cross section.
23. The method of claim 22, wherein the excision array shaping means is at least one of: an excision array mask, a columnator, a distribution cylinder, optic fiber bundles, and a computer pattern generator.
24. The method of claim 22, further comprising distributing the laser energy in a predetermined pattern throughout said area.
25. The method of claim 22, further comprising sensing the temperature of collateral tissue to ensure that collateral tissue coagulation does not occur.
26. The method of claim 22, further comprising employing cryogenics configurations for cooling the tissue, wherein the configurations exceed tissue coagulation temperature.
27. The method of claim 22, further comprising removing said plural tissue portions substantially simultaneously.
28. The method of claim 22, further comprising removing said plural tissue portions substantially sequentially.
29. A laser device comprising: a laser energy source adapted to operably generate laser energy; a distribution device adapted to operably distribute the generated laser energy to a fiber optic guide,- wherein the fiber optic guide comprises at least one fiber optic element and is configured to guide the laser energy to an excision array shaping means,- wherein the excision array shaping means guides laser energy to a tissue surface over a designated area to excise at least one of a plurality of tissue portions in a predetermined pattern.
30. The laser device of claim 29, wherein the fiber optic guide comprises a bundle of a plurality of fiber optic elements .
31. The laser device of claim 30, wherein the bundle of the plurality of fiber optic elements comprises at least one of: different diameters, different cross-sectional shapes, and navicularly shaped bundles .
32. The laser device of claim 30, wherein the excision array shaping means comprises at least one navicularly shaped bundle of the plurality of fiber optic elements at an end of the fiber optic guide.
33. The laser device of claim 29, wherein the distribution device is adapted to rotate about a longitudinal axis.
34. The laser device of claim 33, wherein a motor device moves the distribution device.
35. The laser device of claim 33, wherein the laser energy is pulsed and applied to at least one fiber and wherein the motor device moves to cause the laser energy to be applied to at least one other fiber.
36. The laser device of claim 29, wherein the distribution device comprises fiber optic bundles adapted to distribute the laser energy to at least an aligned array fiber bundle of the excision array shaping means, wherein all of the laser energy is applied to one fiber bundle at a time.
37. The laser device of claim 29, wherein the distribution device comprises a distribution cylinder.
38. The laser device of claim 29, wherein a focal spot of the laser energy is shaped to avoid interstitial tissue.
39. The laser device of claim 29, wherein the laser energy comprises at least one of: low power, low energy, high power, high energy, single burst, multi-burst, C02 , low pulse duration, high pulse duration, high frequency, and low frequency.
40. A method of delivering laser energy to excise tissue comprising delivering the laser energy in a matrix of first pixels to substantially fill each of a plurality of similarly shaped regions, and for each region, repeating delivery of said laser energy to excise tissue between said first pixels in at least one of said similarly shaped regions.
41. The method of claim 40 wherein said delivery of laser energy is repeated for plural ones of said similarly shaped regions .
42. The method of claim 40 wherein the laser energy is delivered via pulsing.
43. The method of claim 42 wherein said laser energy is delivered by using plural fibers.
44. The method of claim 43 wherein said laser energy is delivered using a movable fiber, movement of which is controlled via a computer, said computer being programmed with a prescribed pattern.
PCT/US2008/054258 2007-02-16 2008-02-19 Laser surgical device and methods of use WO2008101243A2 (en)

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Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060004347A1 (en) * 2000-12-28 2006-01-05 Palomar Medical Technologies, Inc. Methods and products for producing lattices of EMR-treated islets in tissues, and uses therefor

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060004347A1 (en) * 2000-12-28 2006-01-05 Palomar Medical Technologies, Inc. Methods and products for producing lattices of EMR-treated islets in tissues, and uses therefor

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