KR102448313B1 - Pixel Array Medical Systems, Devices and Methods - Google Patents

Abstract

Systems, tools, methods, and compositions for removing epidermal portions within a donor site in a patient and harvesting skin plugs within the donor site are described. The injectable filler is formed by mincing a skin plug. The injectable filler is configured for injection into a receptacle of a patient.

Description

Pixel Array Medical Systems, Devices and Methods

This application claims the benefit of US Patent Application No. 62/331,076, filed on May 3, 2016.

This application claims the benefit of US Patent Application No. 62/456,775, filed on February 9, 2017.

This application claims the benefit of US Patent Application No. 62/481,391, filed April 4, 2017.

This application is a continuation-in-part of U.S. Patent Application Serial No. 15/431,247, filed on February 13, 2017.

This application is a continuation-in-part of U.S. Patent Application Serial No. 15/431,230, filed on February 13, 2017.

This application is a continuation-in-part of U.S. Patent Application Serial No. 15/017,007, filed on February 5, 2016.

This application is a continuation-in-part of U.S. Patent Application Serial No. 15/016,954, filed on February 5, 2016.

This application is a continuation-in-part of U.S. Patent Application Serial No. 14/840,274, filed on August 31, 2015.

This application is a continuation-in-part of U.S. Patent Application Serial No. 14/840,307, filed on August 31, 2015.

This application is a continuation-in-part of U.S. Patent Application Serial No. 14/840,290, filed on August 31, 2015.

This application is a continuation-in-part of U.S. Patent Application Serial No. 14/840,267, filed on August 31, 2015.

This application is a continuation-in-part of U.S. Patent Application Serial No. 14/840,284, filed on August 31, 2015.

This application is a continuation-in-part of U.S. Patent Application Serial No. 14/840,274, filed on August 31, 2015.

This application is a continuation-in-part of US Patent Application Serial No. 14/505,183, filed on October 2, 2014.

This application is a continuation-in-part of U.S. Patent Application Serial No. 14/505,090, filed October 2, 2014.

This application is a continuation-in-part of U.S. Patent Application Serial No. 14/099,380, filed December 6, 2013.

This application is a continuation-in-part of U.S. Patent Application Serial No. 14/556,648, filed December 1, 2014, which is part of U.S. Patent Application Serial No. 12/972,013, filed December 17, 2010 (now U.S. Patent No. 8,900,181). to be.

Embodiments herein relate to medical systems, devices or devices, and methods, and more particularly, to medical devices and methods applied to the surgical management of burns, skin scars, and hair transplants.

The aging process can best manifest itself as a development of dependent skin relaxation. This whole-life process can become prominent as early as the 20s, and then gradually worsen thereafter. Histological studies have shown that dependent stretching or age-related laxity of the skin is partly due to progressive dermal atrophy associated with a decrease in skin tensile strength. In combination with the downward force of gravity, age-related dermal atrophy will result in a two-dimensional expansion of the skin membrane. The clinical symptom of this medical-histologic process is excessive skin laxity. The areas most affected are the head and neck, upper arms, thighs, chest, lower abdomen, and knee areas. The most prominent of all areas are the head and neck. In these areas, the noticeable "turkey gobbler" relaxation of the neck and "jowl" of the lower face are due to the aesthetic dependence of the skin in these areas.

A plastic surgery procedure has been developed to excise excess flaccid skin. These procedures typically require the use of long incisions hidden around anatomical boundaries, such as mastectomy for facelift ears, scalp, and breast elevations (mammoplasty). However, some areas of flaccid excision are an insufficient compromise between the aesthetic enhancement of more firm skin and the visibility of the surgery. For this reason, skin relaxation of the upper arm, patella, thigh and hip is usually not resected due to the visibility of the surgical scar.

The frequency and negative social impact of this aesthetic transformation has prompted the development of the "face lift" surgical procedure. Other related plastic surgeries in other areas include Abdominoplasty (abdomen), Mastopexy (breast) and Brachioplasty (upper arm). The inherent side effects of these surgical procedures are postoperative pain, scarring, and risk of surgical complications.

Although esthetic improvement by these procedures may be acceptable for significant surgical incisions that are required, there is always and always potential for extensive and permanent scarring with these procedures. For this reason, plastic surgery procedures are designed to hide extensive scarring around the anatomical boundaries, such as the hairline (facial lift), the inframammary line (mammoplasty), and the inguinal fold (abdominoplasty). However, many of these incisions are hidden away and hidden in the skin relaxation area, so their effectiveness may be limited. Other areas of skin relaxation, such as the suprapatellar (superior) knee, are not fixable with plastic surgery incisions due to poor trade-off to more visible surgical scars.

More recently, electromagnetic medical devices (ie, Thermage) that create a reverse thermal gradient have been tried with variable success rates to tighten skin without surgery. At this time, these electromagnetic devices are arranged to give the patient an appropriate degree of skin relaxation. Because of the limitations of electromagnetic devices and the potential side effects of surgery, minimally invasive techniques are required to avoid surgical-related scarring and clinical fluctuations in electromagnetic heating of the skin. For many patients with age-related skin laxity (sagging of the neck and face, arms, armpits, thighs, knees, buttocks, abdomen, bra line, chest), excessive partial incision of the skin is a significant segment of typical plastic surgery. can be increased

Even more important than cosmetic alteration of the skin membrane is the surgical management of burns and other trauma-related skin imperfections. Significant burns are classified by the total body surface area burned and the thickness of the thermal fracture. Generally, first-degree and second-degree burns are managed in a non-surgical manner by application of topical creams and dressings for burns. More severe third-degree burns involve full-thickness thermal destruction of the skin. Surgical management of this serious injury includes debridement of the burn crust and application of a partial-thickness skin graft.

Any full-thickness skin defect most frequently formed from burns, trauma, or incisions of skin masses can be closed with flap transfers or skin grafts using current commercial instruments. Both surgical methods require harvesting from the donor site. The use of skin flaps (flaplets) is further limited by the need for pedicle blood supply and, in most cases, to directly suture the donor site.

Due to immune constraints, the partial-thickness skin graft procedure requires the collection of autologous skin grafts from the same patient. Typically a donor on a burn patient is selected from a non-burned area and a lamellar piece of skin is collected from that area. After this procedure, a partial-thickness skin defect develops at the donor site. This donor defect resembles a deeper second-degree burn. Often, healing by re-epithelialization of the donor site is painful and can last for several days. Additionally, there are visual donor site variations that are permanently thinner and more discolored compared to the surrounding skin. For patients with burns over a significant surface area, extensive collection of skin grafts from non-burned areas may be limited.

For this reason, there is a need for procedures and instruments for aesthetic surgical skin tightening in the rapidly expanding cosmetic market. There is therefore a need for a system, apparatus or apparatus and procedure that eliminates such donor site modifications while providing a means for repeatedly collecting skin grafts from the same donor site.

INCLUDING BY REFERENCE

Each patent, patent application, and/or publication mentioned in this specification is hereby incorporated by reference to the same extent as when each such patent, patent application and/or publication was specifically and individually intended to be incorporated by reference. Included.

1 is a PAD kit disposed in a target area according to one embodiment.
Fig. 2 is a cross-sectional view of a scalpel punch or device including a scalpit array in accordance with one embodiment;
Fig. 3 is a partial cross-sectional view of a scalpel punch or device including an array of scalpels in accordance with one embodiment;
4 is an adhesive film having a backing (adhesive substrate) included in a PAD kit according to an embodiment.
5 shows an adhesive film (adhesive substrate) when used with a PAD kit frame and blade assembly according to one embodiment.
6 illustrates the removal of skin pixels in one embodiment.
7 is a side view of blade incision and removal of a skin pixel dissected with a PAD kit, according to one embodiment.
8 is an isometric view of blade/pixel interaction during a procedure using a PAD kit according to one embodiment.
FIG. 9 is another view during the procedure using the PAD kit (blade removed for clarity) showing both the skin pixels or plugs that have been dissected and captured and collected and the skin pixels or plugs that have not been dissected before being dissected.
10A is a side view of a portion of a pixel array showing a fixed scalpel on a plate in accordance with one embodiment;
10B is a side view of a portion of a pixel array showing a scalpel fixed on a plate in another embodiment;
10C is a plan view of a scalpel fit according to one embodiment;
10D is an enlarged view of a portion of a scalpel, according to one embodiment.
11A is an illustration of a rolling pixel drum according to an embodiment.
11B is an illustration of a rolling pixel drum assembled on a handle according to an embodiment.
11C is a drum slice for use with a scalpel, according to one embodiment.
12A is a drum pit disposed over a scalpel, according to one embodiment.
12B is an optional view of a drum pit positioned over a scalpel, according to one embodiment.
13A illustrates the application of a drum puncture across a scalpel, in one embodiment, where an adhesive film is applied to the drum of the puncture before rolling across the plate in accordance with the embodiment.
13B is a side view of a portion of a drum pit showing the blade position relative to the scalpel, according to one embodiment.
13C is a side view of a portion of a drum pit showing another blade position relative to the scalpel, according to one embodiment.
13D is a side view of a drum slice with different blade positions relative to the scalpel, according to one embodiment.
13E is a side view of a drum dermis with an incision blade clip showing incision of a skin pixel by the blade clip, according to one embodiment.
13F is a bottom view of a scalpel pit and drum pit, according to one embodiment.
13G is a front view of a scalpel pit and a drum pit, according to one embodiment.
13H is a rear view of a scalpel pit and drum pit, according to one embodiment.
14A is an assembled view of a ligament with a pixel onlay sleeve (POS), in one embodiment.
14B is an exploded view of a pterygoid with a pixel on ray sleeve (POS) in one embodiment.
14C is a portion of a ligament with a pixel onlay sleeve (POS), in one embodiment.
FIG. 15A is a slip-on pad slid over a Paget drum ganglion, in accordance with one embodiment.
15B is an assembly view of a slip-on pad installed on a Paget drum crust, in accordance with one embodiment.
FIG. 16A shows a slip-on PAD installed on a Paget drum crust and used with a perforated template or guide plate in one embodiment.
16B is skin pixel collection using a Paget drum skinned and installed slip-on pad, according to one embodiment.
17A is an illustration of a pixel drum dermis applied to a target area of a skin surface, in accordance with one embodiment.
17B is an optional view of a portion of a pixel drum dermis applied to a target area of a skin surface, in accordance with one embodiment.
18 is a side perspective view of a PAD assembly according to one embodiment;
19A is a top perspective view of a scalpelfit device for use with a PAD assembly in accordance with one embodiment;
19B is a bottom perspective view of a scalpelfit device for use with a PAD assembly, in accordance with one embodiment.
20 is a side view of a punch percussion device including a vacuum component in one embodiment;
21A is a top view of a vibrating plane scalpel array and blade arrangement, according to one embodiment.
21B is a bottom view of the vibrating plane scalpel array and blade arrangement in one embodiment.
21C is an enlarged view of the planar array when the array of scalpels, blades, adhesive film and adhesive beaker are assembled together in accordance with one embodiment.
21D is an enlarged view of a planar array with feeder elements in one embodiment.
22 is a dermal matrix cut cylindrically similar to the size of a skin pixel graft collected according to an embodiment.
23 is a drum array drug delivery device according to an embodiment.
24A is a side view of a needle array drug delivery device in one embodiment.
24B is a top view of a needle array drug delivery device in one embodiment.
24C is a bottom view of a needle array drug delivery device in one embodiment.
25 is a human skin structure.
26 is a menstrual cycle of hair growth.
27 depicts collection of donor pores in one embodiment.
Fig. 28 shows the preparation of the receptacle in one embodiment.
29 is a disposition of a hair plug collected in a receptacle in one embodiment.
30 is a disposition of a perforated plate in the occipital scalp donor site, according to one embodiment.
FIG. 31 is the depth of scalp pit penetration through the skin when the scalp pit is configured to penetrate the subcutaneous fat layer and entrap pores, according to one embodiment.
32 illustrates hair plug collection using a perforated plate at the occipital donor site, according to one embodiment.
33 illustrates the creation of a visible hairline in one embodiment.
34 illustrates the preparation of a receptacle using a patterned perforated plate and a spring-loaded pixelating device to create identical skin defects in the receptacle according to one embodiment.
35 illustrates implantation of a collected plug by inserting the collected plug into a corresponding skin defect created in a receptacle according to an embodiment.
Fig. 36 shows the clinical purpose of using the pixel dermabrasion and procedure in one embodiment.
37 is an image of skin marked at the edge and midpoint of an area to be incised according to an embodiment.
38 is an image of a skin ablation area after surgery in one embodiment.
39 is an image after 11 days of procedure showing treated resections with margins measured per primam in one embodiment.
40 is an image after 29 days of procedure showing the maturation of treated ablation per primam and successive ablation areas per primam with measured margins according to one embodiment.
FIG. 41 is an image after 29 days of procedure showing maturation of treated ablation areas per primam and successive ablation areas per primam with measured lateral dimensions according to one embodiment.
FIG. 42 is a 90-day post-procedural image showing the maturation of treated ablation areas per primam and successive ablation areas per primam with measured lateral dimensions according to one embodiment.
43 is a scalpel illustrating applied rotational and/or impact forces in accordance with one embodiment.
44 shows a geared scalpel and an array including a geared scalpel in accordance with one embodiment.
45 is a bottom perspective view of an ablation device including a scalpel assembly having a geared scalpel array, in accordance with one embodiment.
Figure 46 is a bottom perspective view of a scalpelfit assembly having a geared scalpel array (housing not shown) in one embodiment;
47 is a detailed view of a geared scalpel pit array in one embodiment.
48 is an array including scalpels in a friction drive configuration in one embodiment.
49 is a helical scalpel (external) and an array including the helical scalpel (external) in one embodiment.
50 is a side perspective view of a dissecting device comprising a scalpel assembly comprising a helical scalpel array (left) and a scalpelfit assembly having a helical scalpel array (right) (housing) in accordance with one embodiment;
FIG. 51 is a side view of an ablation device comprising a scalpel fit assembly having a helical scalpel array assembly (housing is shown transparent for clarity of detail), in one embodiment;
FIG. 52 is a bottom perspective view of an ablation device comprising a scalpelfit assembly having a spiral scalpel array assembly (housing shown transparently for clarity of detail), in one embodiment;
53 is a top perspective view of an ablation device comprising a scalpelfit assembly having a helical scalpit array assembly (housing shown transparent for clarity of detail), in one embodiment;
54 is a press plate of a spiral scalp fit array according to an embodiment.
Figure 55 shows a spiral scalpel array with a press plate in one embodiment.
56 shows an array including an inner helical scalpel and an inner helical scalpel, in one embodiment.
57 shows a spiral scalpel array with drive plates in one embodiment.
58 shows a slotted scalpel and an array including a slotted scalpel, in one embodiment.
59 illustrates a portion of an array of slotted scalpels (eg, four scalpels) with drive rods, according to one embodiment.
60 illustrates an exemplary slotted scalpel array (eg, 25 scalpels) with drive rods in one embodiment.
61 shows a vibrating pin drive assembly with a scalpel, according to one embodiment.
62 illustrates variable scalpel exposure control using a scalpel guiding plate, according to one embodiment.
63 shows a scalpel assembly including an array of scalpels (eg, spirals) configured to be manually driven by an operator in accordance with one embodiment.
Figure 64 shows the force applied to the scalpel by being applied to the ski.
65 illustrates constant axial force compression using a scalpel, according to one embodiment.
FIG. 66 illustrates kinetic impact force using constant uniaxial force compression plus scalpel fit, in one embodiment.
67 depicts impacting the skin and moving the scalpel fit at a penetrating rate in accordance with an embodiment.
68 shows a multi-needle tip according to an embodiment.
69 shows an unthreaded square (scalpit) (left) and a square scalpel with a plurality of threads (right), according to one embodiment.
70 is a plurality of side, front (or rear) and side perspective views of a round scalpel having a beveled tip in accordance with one embodiment;
71 illustrates a rounded scalpel with serrated edges in accordance with one embodiment.
72 is a side view of an ablation device including a scalpel assembly with a scalpel array and extruded pins (housing shown transparently for clarity of detail), according to one embodiment.
73 is a top cut-away perspective view of an ablation device including a scalpel fit assembly with a scalpel array and extruded pins (housing shown transparently for clarity of detail), in accordance with one embodiment.
74 is a side and top perspective view of a scalpel assembly including an array of scalpels and extruded pins, in one embodiment;
75 is a side view of an ablation apparatus including a scalpel assembly having a scalpel array assembly coupled to a source of vibration, in accordance with one embodiment.
76 illustrates a scalpel array driven by an electromechanical source or a scalpel array generator, according to one embodiment.
77 is a diagram of an ablation apparatus including a vacuum system in one embodiment.
78 is a vacuum manifold applied to a target skin surface to evacuate/collect an ablated skin/hair plug, according to one embodiment.
79 is a vacuum manifold having an integral wire mesh applied to a target skin surface to evacuate/collect an ablated skin/hair plug, according to one embodiment.
80 is a vacuum manifold having an integral wire mesh constructed in vacuum subcutaneous fat in accordance with an embodiment.
81 illustrates a collapsible docking station and embedded skin pixels formed from, but not limited to, an elastomeric material in one embodiment.
82 is a top view of a docking station (eg, elastomer) in stretched (left) and unstretched (right) configurations, in accordance with one embodiment.
83 illustrates the removal of flaccid skin without scarring according to an embodiment.
84 shows tightening the skin without apparent scarring according to an embodiment.
85 depicts a three-dimensional contour of a skin sheath in one embodiment.
86 illustrates variable partial ablation density in a treatment area in one embodiment.
87 shows partial resection of fat in one embodiment.
88 shows cobblestoning of the skin surface.
89 shows topographic mapping for deeper levels of partial fat ablation in one embodiment.
90 depicts a plurality of treatment outlines in one embodiment.
91 illustrates a curve treatment pattern in one embodiment.
92 shows a digital image of a patient with a rendered digital wire mesh program, in one embodiment.
93 shows directed closure of a partially ablated area in one embodiment.
94 shows directional partial ablation of skin according to one embodiment.
95 illustrates shortening of an incision through a continuous partial procedure in accordance with an embodiment.
96 is an illustration of “poison ear” skin relaxation in breast reduction and abdominoplasty.
97 is an sPAD comprising a single skive scalpel with depth control, according to one embodiment.
98 is an sPAD comprising a standard single scalpel in accordance with one embodiment.
99 is an sPAD comprising a pencil-style gear reduction carrier in accordance with one embodiment.
100 is an sPAD comprising a 3x3 array in accordance with one embodiment.
101 is an sPAD comprising a cordless surgical drill for a large array in accordance with an embodiment.
102 is an sPAD comprising a drilled 5x5 centerless array in accordance with an embodiment.
103 is an sPAD comprising a vacuum assisted pneumatic ablation sPAD in accordance with one embodiment.
104 is a VAPR sPAD coupled to a carrier drill via a DAC, according to one embodiment.
105 is a VAPR sPAD in the ready state (left) and extended treatment state (right), in one embodiment.
106 is a SAVR sPAD in a ready state (left) and a contracted state (right) according to an embodiment.
107A is a vacuum aspirator configured to be coupled or attached in series with a vacuum manifold and scalpel array in accordance with one embodiment.
107B is a cross-sectional isometric view of a vacuum aspirator configured to be coupled or attached in series with a vacuum manifold and scalpel array, in accordance with one embodiment.
107C is a solid side view of a vacuum aspirator configured to be coupled or attached in series with a vacuum manifold and scalpel array, in accordance with one embodiment.
108A is a cross-sectional side view of a scalpel pit array for use with a vacuum aspirator in accordance with one embodiment;
108B is an isometric cross-sectional view of an array of scalpels used with a vacuum aspirator in accordance with one embodiment;
108C is a solid side view of an array of scalpels used with a vacuum aspirator in accordance with an embodiment.
109A is a cross-sectional side view of a vacuum manifold configured to be coupled or coupled to a vacuum aspirator in accordance with one embodiment.
109B is a cross-sectional isometric view of a vacuum manifold configured to be coupled to or attached to a vacuum adsorber in accordance with one embodiment.
109C is a solid side view of a vacuum manifold configured to be coupled or attached to a vacuum aspirator in accordance with an embodiment.
110 is a solid side view of an apparatus having a vacuum component configured for manual control through an opening, in accordance with one embodiment.
111A is an isometric view of a hand piece comprising or configured to contain a vacuum under one embodiment;
111B is an isometric cutaway view of a hand piece configured to contain or incorporate a vacuum in accordance with one embodiment.
112 is a cross-sectional side view of a single scalpel device applied to a target tissue area under one embodiment;
113 is an isometric cross-sectional view of a single scalpel device applied to a target tissue region under one embodiment;
114A is a cross-sectional side view of a multiple scalpel device applied to a target tissue region, under one embodiment.
114B is an isometric cross-sectional view of a multi-scalpit device applied to a target tissue region, according to one embodiment.
115 is an exemplary slotted scalpel in accordance with one embodiment.
116 is an exemplary slotted blunt micro tip cannula in accordance with one embodiment.
117 is an exemplary ink stencil marking system in accordance with one embodiment.
118 is an adhesive translucent perforated plastic membrane according to one embodiment.
1193A is a side view of an ASPPMP in use as a depth guide for a single scalpel fit device in accordance with an embodiment;
119B is a top isometric view of an ASPPMP used as a depth guide with a single scalpel device in accordance with an embodiment;
120 is a partial excision of skin and partial transdermal/subcutaneous fat excision in one embodiment.
121 is a side view of submandibular and partial transdermal/subcutaneous fat ablation as target areas for partial ablation of skin, in one embodiment.
122 is a downward (upward view) view of the partial ablation area submandibular as a target area for partial ablation of the skin and subcutaneous fat layer ablation, in one embodiment.
123 is a horizontally aligned treatment area of the submandibular and lateral neck for severe skin relaxation, in one embodiment.
124 is a wider partial liposuction of the submandibular region for severe lipodystrophy, in one embodiment.
125 is an exemplary face vector and neck vector indicating closing, in one embodiment.
126 shows the Langer line of the closure.
127 is a marked target area for partial ablation of neck and submandibular microfatectomy, in one embodiment.
128 is an exemplary stencil, in one embodiment.
129 is an indicated closure vector of the submandibular and anterior neck, in one embodiment.
130 is a modification of Z-plasty and W-plasty scars.
131 is an illustration of a partial wound area removal technique of scar ablation, in one embodiment.
132 is an illustration of partial scar resection for a broad hypotrophic scar, in one embodiment.
133 is an illustration including shortening of the lower incision as applied to breast reduction and/or breast repositioning, in one embodiment.
134 is an illustration of a flap closure.
135 is an illustration including a partial skin graft harvest to be applied to a donor site according to one embodiment.
136 is an illustration including angiogenesis of a partial skin graft in a receptacle, in one embodiment.
137 is an exemplary docking station including a docking tray and an adjustable slide, in one embodiment.
138 shows, for example, a face with target tissue including furrows and wrinkles.
139 is a partially dissected area (skin plug in situ), in one embodiment.
140 is a detailed view of partial skin excision scar harvesting, in one embodiment.
141 is an illustration with a skin plug harvested using a membrane attached directly to the drum dermis, in one embodiment.
142 illustrates removal of an epidermal component by ablating a skin plug created by a dermatome with an outrigger blade of the dermatome, in one embodiment.
143 depicts individually harvested skin plugs on a membrane, wherein the membrane is applied to a dermatome (eg, drum) in one embodiment.
144 is a non-compressible mogelizer configured to mechanically grind a skin plug into a viscous liquid, in one embodiment.
145 shows injection of LADMIX filler in a target tissue region, in one embodiment.
146 is an illustration of a scalpel device including a multifunction chamber, in one embodiment.
147 is an exemplary vacuum flow path through the scalpel device, in one embodiment.
148 is an exemplary scalpel device following collection of pixels within a collection chamber, in one embodiment.
149 is an inverted hand piece with a pixel in the collection chamber, in one embodiment.
Figure 150 is an inverted hand piece with replacement end caps and fitting plugs installed, in one embodiment.
151 is a hand piece having a fine blade attached and positioned within a collection chamber with a pixel solution, in one embodiment.
152 is a LADMIX filler inhaled into a syringe, in one embodiment.
153 shows a syringe and attached needle prepared for injecting LADMIX filler into a target tissue region, in one embodiment.
154 is a skin blister formed within an entire partial area, in one embodiment.
155 is a partial region after removal of blister tissue covering the entire partial region, in one embodiment.
156 illustrates the formation of a plurality of skin blisters, in one embodiment.
157 illustrates a plurality of subregions after removal of blister tissue overlying the subregions, in one embodiment.
158 shows, in one embodiment, harvesting skin plugs within a blister area using a single scalpel system or multiple scalpel arrays.
159 is a collection container or canister comprising a harvested skin plug, in one embodiment.
160 is a mincer container or canister comprising a harvested skin plug, in one embodiment.
161 is a manual mincer comprising a blade arrangement configured to be manipulated up/down/left/right and/or rotationally, in one embodiment.
162 is an electric mincer comprising a blade or cutting device configured to be rotated by power, in one embodiment.
163 is an example of displaying a system template, in one embodiment.
164 illustrates creation of a receiving pocket for an injectable pocket, in one embodiment.
165 is a receiving pocket with an implanted filler, in one embodiment;
166 shows female urinary incontinence treatment using injection of LADMIX, in one embodiment.

Systems, tools, methods and compositions are disclosed for removing a portion of the epidermis within a donor site of a patient and harvesting a skin plug within the donor site. The injectable filler is formed by mincing a skin plug. The injectable filler is configured for injection into a receptacle of a patient.

Systems, tools, and methods are described wherein a scalpel device includes a housing configured to contain a scalpel assembly. The scalpel assembly includes an array of scalpels and one or more guide plates. The array of scalpels includes a set of scalpels, and in an embodiment the set of scalpels includes a plurality of scalpels. The guide plate maintains the configuration of the scalpel set. The scalpel set is configured to deploy from the housing and retract into the housing, and when deployed, to create an ablated skin pixel in the target area. The excised skin pixels are collected.

The embodiments described herein satisfy the expanding aesthetic market for instruments and procedures for cosmetic surgical skin treatment. Additionally, according to embodiments, it is allowed to repeatedly collect skin grafts from the same donor while eliminating donor site modifications. Embodiments described herein are configured to incise excessively flaccid skin without visual scarring so that all areas of excessive flaccid skin can be ablated by pixel array nodes and in a pre-limited area due to the visibility of the surgical incisions. A procedure may be performed. The technical effect implemented through the embodiments described in this specification is that the skin becomes smooth and firm without visual scars or long scars along anatomical boundaries.

Embodiments detailed herein, including skin graft devices and methods, are configured to provide the ability to repeatedly collect sub-layer skin grafts without visual scarring of the donor site. During the procedure, a pixel array nodule (PAD) is used to collect skin grafts from selected donors. During the collection procedure, a pixelated skin graft is deposited on a flexible, semi-porous, adhesive membrane. The collected skin graft/membrane complex is then applied directly to the awarding skin defect area. The partially incised donor site is sutured upon application of an adhesive sheeting or bandage (eg Flexan® sheeting, etc.) that functions as a large butterfly bandage for a period of time (eg, a week, etc.). Endothelial defects formed by PAD can facilitate the primary healing process in which the normal epidermal-dermal structure is realigned in an anatomical manner to minimize scar formation. Also after surgery, the adhesive membrane is peeled off together with the stratum corneum of the graft, after which the membrane can be removed without rupture of the graft at the recipient site. It is worth explaining the many effects realized by the pixel skin graft procedure. Because the skin graft is pixelated, a gap is provided for drainage between the skin plug components and improves the percentage "take" compared to a sheet skin graft. During the first week after surgery, the skin graft will "engraft" into the donor site by an angiogenic process in which new blood vessels from the skin defect grow into the new skin graft. A semi-porous membrane will conduct the exudate into the dressing interior.

The flexible membrane was designed to have elastic recoil properties that facilitate the apposition of the component skin plug within the graft/membrane composite and promote primary adjacent healing of the skin graft plug, resulting in a uniform sheeting of the pixelated appearance of the skin graft. form can be transformed. Furthermore, the membrane aligns the microstructural component skin plugs, whereby the epidermis aligns with the epidermis and the dermis aligns with the dermis, facilitating a primary healing process that reduces scarring.

There are a number of major clinical applications for the dermis described in detail herein, including partial skin plugs for skin treatment, partial hair transplants for alopecia, and partial skin collections for skin grafts. The partial skin plug of an embodiment includes collecting the skin plug using an adhesive membrane, but the partially incised skin plug may be excised without collection. Examples of incisions, excisions and sutures are most illustrative of clinical applications for skin treatment. Embodiments described herein are configured to provide a larger array of scalpels with a greater number of scalpels and to aid in dissection and excision, embodiments comprising skin surface dissection means.

A pixel array medical system, apparatus or device and method are described for skin grafting and skin ablation procedures and hair transplantation procedures. In the following description, numerous specific details are set forth to provide a thorough understanding of and enable description of the embodiments herein. However, it will be apparent to one skilled in the art that these embodiments may be practiced without one or more of the specific details above or with other components, systems, etc. In other instances, well-known structures or operations have not been shown or described in detail in order to avoid obscuring aspects of the disclosed embodiments.

As may be used herein, the following terms have the following general meanings. However, this term is not limited to the meaning given herein, as the meaning of any term may include other meanings that may be understood or applied by one of ordinary skill in the art. "First degree burns" as used herein include superficial lacerations in which there is no rupture of the epidermis from the dermis. First degree burns are visualized as erythema (redness) of the skin.

"Second degree burns" as used herein include relatively deeper burns in which there is a rupture of the epidermis from the dermis and also the variable thickness of the dermis is altered. Most second-degree burns are associated with blister formation. Deep second-degree burns can usually degenerate into full-thickness third-degree burns by oxidation or infection.

"Third degree burns" as used herein include burns associated with full-thickness thermal destruction of the skin, including the epidermis and dermis. Third-degree burns may be associated with recessive destruction of deeper underlying tissues (subcutaneous and muscle layers).

As used herein, “ablation” includes removal of tissue by destruction of the tissue, eg, laceration of a skin injury with a laser.

"Autograft" as used herein includes grafts taken from the same patient.

A “backed adherent membrane” as used herein includes an elastic adhesive membrane that captures a transversely transected skin plug. In one embodiment a backing adhesive film is backed on the outer surface to maintain alignment of the skin plug during collection. After collection of the skin plug, the backing is removed from the adhesive film with the collected skin plug. A membrane according to an embodiment is porous to allow drainage when placed in the donor site. The membrane of one embodiment may also have elastic rebound properties, so that when the backing is removed, the sides of the skin plug may be brought into close proximity to each other to promote healing at the donor site as a platelet graft.

"Burn scar shrinkage" as used herein includes the treatment of scar tissue that occurs during the wound healing process. This process is more likely to occur with untreated third-degree burns.

"Burn scar contracture" as used herein includes bands of scar tissue that limit the range of motion of a joint or bands of scar tissue that distort the patient's appearance, eg, burn scar contractures of the face.

As used herein, “dermis” includes an instrument that “ablates the skin” or collects a partial-layer skin graft. Examples of drum fibrils include Padgett and Reese fibrils. The motorized fibrillation is the Zimmer fibrillation and is an electric version of the Padgett fibrillation.

"Dermis" as used herein is the major structural support and includes the deep skin layer comprising predominantly non-cellular collagen fibers. Fibroblasts are cells in the dermis that form collagen protein fibers.

As used herein, a “donor site” includes an anatomical region from which a skin graft is collected.

"Epidermal" as used herein includes the outer layer that includes living epidermal cells and non-living stratum corneum and serves as a biological barrier.

As used herein, “excise” includes surgical removal of tissue.

“Ablative skin defects” as used herein include partial or more generally full-thickness defects resulting from surgical removal (excision/resection) of skin (lesions).

“FTSG” as used herein includes full-thickness skin grafts in which the entire layer of skin is collected. With the exception of instruments as described herein, the donor site is closed as a surgical incision. For this reason, FTSGs are limited in the surface area that can be collected.

"Granulation Tissue" as used herein includes highly vascular tissue that grows in response to the absence of skin in a full-thickness skin defect. Granulation tissue is an ideal basis for skin graft donors.

"Healing by primary intention" as used herein includes a wound healing process in which normal anatomy is reconstructed with minimal scar tissue formation. Morphologically, scarring is less likely to be visible.

“Healing by secondary intention” as used herein includes a less organized wound healing process in which healing occurs in which normal anatomy is less aligned and scar collagen formation is increased. Morphologically, the scar is likely to be visible.

"Allograft" as used herein includes a graft taken from another human and applied to a patient's donor site as a temporary biological dressing. Most allografts are collected as cadaver skin. Temporary “engraftment” of the allograft can be partially with immunosuppression, but eventually the allograft is replaced with an autograft if the patient survives.

"Incision" as used herein includes surgical incision without removal of tissue.

"Mesh sub-layer skin graft" as used herein includes sub-layer skin grafts in which the surface area is expanded by repeatedly dissecting collected skin grafts using an instrument referred to as a "mesh". Mesh sub-layer skin grafts have a higher percentage of 'engraftment' than sheet grafts because they allow drainage through the graft and are better able to conform to the irregular contours of the donor site. However, this results in grafts having a mesh-like appearance that is offensive to the donor site.

"PAD" as used herein includes a Pixel Array node, a type of instrument for fractional skin resection.

A “PAD kit” as used herein is a disposable procedure comprising a perforated guide plate, a scalpel stamper, a guide plate frame, a backing adhesive film and an incision blade. Includes kit.

A “perforated guide plate” as used herein includes a perforated plate comprising an entire graft collection area in which the holes in the guide plate are aligned with the scalpel of a handheld stamper or slip-on PAD. The plate will also serve as a guard against unintentional laceration of adjacent skin. The holes in the guide plate may be of different geometries, including but not limited to round, oval, square, rectangular, and/or triangular.

"Pixelized full-thickness skin graft" as used herein includes full-thickness skin grafts collected by an instrument as described herein without reduced visually significant scarring at the donor site. The graft will also have an improved appearance at the donor site similar to sheet FTSG, but will be more compliant with the donor site and have a higher percentage of 'engraftment' due to the draining gap between the skin plugs. Another significant advantage of pixelated FTGS compared to sheet FTSG is that it may allow for larger surface area grafts that would otherwise have required STSGs. This advantage is due to the ability to collect from multiple donors with reduced prickly scarring.

“Pixelized graft collection” includes collection of skin grafts from a donor site by an instrument as detailed herein.

“Pixelized sub-layer skin graft” as used herein includes sub-layer skin grafts collected using an SRG instrument. The skin grafts share the benefits of mesh skin grafts with and without unsightly donors.

"Donor site" as used herein includes the area of a skin defect to which a skin graft is to be applied.

As used herein, “ablation” includes incision.

"Scalpel" as used herein includes a single-edged knife that cuts through skin and soft tissue.

"Scalpit" as used herein includes the term referring to a scalpel of a small geometric shape (or round, oval, rectangular, square, etc.) that cuts through a plug of skin.

As used herein, “scalpit array” includes an arrangement or array of a plurality of scalpels secured to a substrate (eg, a base plate, stamper, handle-type stamper, tip disposable tip, etc.).

A “scalpit stamper” as used herein includes a handle-type scalp fit array instrument component of a PAD kit that cuts a skin plug through a perforated guide plate.

As used herein, “scarring” includes histological deposition of tissue-disrupted collagen after wounding, and morphological changes that are visually noticeable from histological deposition of tissue-disrupted collagen after wounding.

"Sheet full-thickness skin graft" as used herein includes application of FTSG as a continuous sheet to the donor site. The appearance of FTSG is superior to that of STSG, and for this reason it is mainly used for skin grafting in visually prominent areas such as the face.

"Sheet sub-layer skin graft" as used herein includes sub-layer skin grafts that are continuous sheets and are associated with conventional donor site modifications.

"Skin defect" as used herein includes the absence of a full layer of skin that may include the subcutaneous fat layer and deeper structures such as muscles. Skin defects can result from a variety of causes, namely, surgical resection of burns, trauma, cancer, and birth defects.

As used herein, "Skin Pixel" includes a portion of the dermis or the entire layer of the dermis that is incised by a scalpel and a portion of the skin including the epidermis, and a skin pixel is a cuff of subcutaneous fat or comprising the same. It may include skin adnexa, such as pores, and may also include skin plugs.

A “skin plug” as used herein is a circular (or other geometric shape) of the epidermis and a partial or full layer of the dermis incised by the scalpel and incised by the incision blade and captured by the backing adhesive membrane. Contains skin fragments.

As used herein, "STSG" includes a Partial Thickness Skin Graft in which a portion of the epidermis and dermis is collected by transplantation.

As used herein, “subcutaneous fat layer” includes the layer that lies just below the skin and is mainly composed of fat cells referred to as lipocytes. This layer serves as the main protective layer for the surroundings.

As used herein, a “transection blade” includes a horizontally aligned single-sided blade that is fitted into the frame of a perforated plate or adhered to the outrigger arm of a drum slice, as described in detail herein. The incision blade cuts the base of the incised skin plug.

"Wound healing" as used herein includes unconditional biological processes arising from any type of wound, whether one or more recessive, motor, or surgical.

"xenograft" as used herein includes a graft taken from another species and applied to a patient's donor site as a temporary biological dressing.

A plurality of embodiments of a pixel array medical system, apparatus or apparatus and method are described in detail herein. The systems, instruments or devices and methods described herein are minimally invasive surgical procedures for treating flaccid skin and skin grafts without visual scarring via devices used in a variety of surgical procedures, such as cosmetic surgery procedures and further hair transplants. including methods. In some embodiments, the device is a disposable device. Embodiments herein perform multiple small pixelated ablations of skin as minimally invasive as selectively minimally invasive to large plastic surgical ablation of the skin, preventing surgical-related scarring of the skin and clinical fluctuations in electromagnetic heating of the skin. Embodiments herein may also be used in hair transplantation and areas of the body that may be limited to cosmetic surgery due to the visibility of surgical scars. Additionally, the method can be performed on a skin defect area of a patient with reduced scarring of the patient's donor site by collecting an incised section of skin from the tissue of the donor area.

For many patients with age-related skin laxity (including, but not limited to, neck and face, arms, armpits, thighs, knees, buttocks, abdomen, bra line, chest sagging, etc.), the minimally invasive pixel array medical use herein The device and method perform a pixelated incision/ablation of excess skin to replace the unavoidable scarring with cosmetic surgery. In general, but not limited to, the procedures described herein are performed under local anesthesia with minimal perioperative discomfort. When compared to the long-term healing state after plastic surgery, only a short recovery cycle is required, preferably by applying a support garment to be worn in the dressing and treatment area for a predetermined period (eg, 5 days, 7 days, etc.). There will be minimal or no pain associated with the procedure.

Relatively small (eg, in the range of about 0.5 mm to 4.0 mm) skin defects formed by the instruments described herein will be closed by application of an adhesive Flexan® sheet. When functioning as a large butterfly bandage, the Flexan® sheet can be pulled in a direction ("vector") that maximizes cosmetic contouring of the treatment area. To further aid in cosmetic contouring, an elastic compression garment is applied over the dressing. After the initial healing phase is complete, a plurality of small linear scars in the treatment area will have reduced visibility as compared to larger cosmetic incisions on the treatment area. Because of the delayed wound healing response, additional skin treatments may occur over several months. Still other possible applications of the embodiments described herein include hair transplantation as well as treatment of hair loss, snoring/sleep apnea, orthopedic/physiotherapy, vaginal treatment, female urinary incontinence, and gastrointestinal sphincter treatment.

Significant burns are classified by the total body surface area burned and the depth of thermal breakdown and the methods used to manage these burns are highly dependent on the classification. Typically, first- and second-degree burns are managed non-surgically using topical creams and burn dressings. Deeper third-degree burns are associated with full-thickness thermal destruction of the skin resulting in full-thickness skin defects. In general, surgical management of these serious injuries involves debridement of the burn crust and application of a partial-thickness skin graft.

Full-thickness skin defects most frequently formed from burns, trauma, or excision of skin malignancies can be sutured by skin flap transfer or skin graft using conventional commercial instruments. Both surgical methods require collection from the donor site. The use of skin flaps is further limited because the use of flaps must include the supply of stem blood and, in most cases, the donor site must be sutured directly.

Due to immunological constraints, the partial-thickness skin graft procedure requires the collection of autologous skin grafts from the same patient. Typically, a burn patient's donor site is selected from an unburned area and a sublayer sheet of skin is collected from that area. After this procedure, partial-thickness skin defects are inevitably formed at the donor site. This donor defect itself resembles a deep second-degree burn. Healing by re-epithelialization of this area is often painful and can last for several days. Additionally, it typically results in a visual donor site deformity that is permanently thinner and more discolored than the surrounding skin. For patients with burns over significant surface areas, extensive collection of skin grafts may also be limited by the availability of non-burned areas.

All of the conventional surgical modalities for closure of skin defects (flap transfer and skin grafting) involve significant scarring of the skin defect donor site as well as the donor site from which the graft is collected. In contrast to conventional procedures, embodiments described herein eliminate this donor site variation and provide a method for re-collecting skin grafts from any existing donor site, such as a sheet or pixelated hyperglottic region, for pixel skin grafting. Also referred to as the Pixel Skin Grafting Procedure, or Pixel Array Procedure. This ability to re-collect skin grafts from existing donor sites will reduce the surface area requirements for donor skin in severely burn patients with non-burned donor skin of limited surface area and provide additional skin graft capability.

The pixel skin graft procedure of one embodiment is used as a full-thickness skin graft. Many clinical applications, such as facial skin transplantation, hand surgery, and repair of congenital anomalies, are most preferably performed using full-thickness skin transplantation. The texture, pigmentation and overall morphology of full-thickness skin grafts more closely resembles the skin adjacent to the defect than with partial-thickness skin grafts. For this reason, full-thickness skin grafts have a better appearance than partial-thickness skin grafts in areas of visual conspicuousness. A major drawback to full-thickness skin grafts under conventional procedures is the extensive linear scar formed by surgical closure of full-thickness donor site defects, which limits the size and usefulness of full-thickness skin grafts.

In comparison, the full-thickness skin graft of the pixel skin graft procedure described herein is less limited by size and usefulness as the linear donor scar is removed. Thus, many skin defects that are typically covered by a partial-thickness skin graft will be treated using a pixelated full-thickness skin graft.

The pixel skin graft procedure provides the ability to collect sub- and full-thickness skin grafts with minimal visual scarring of the donor site. During the procedure, a pixel array adenoid (PAD) device is used to collect skin grafts from selected donors. During the collection procedure, a pixelated skin graft is deposited onto an adhesive film. The adhesive film of the embodiment includes a flexible semi-porous adhesive film, but the embodiment is not limited thereto. The collected skin graft/membrane complex is then applied directly to the awarding skin defect area. The partially resected donor site is closed by application of an adhesive Flexan® sheet that functions as a large butterfly bandage for one week. Relatively small (eg 15 mm) intradermal circular skin defects can be sutured to facilitate the primary healing process in which the normal epidermal-dermal structure is realigned in an anatomical manner to minimize scar formation. Also, approximately one week after surgery, the adhesive membrane is shed (peeled) along with the stratum corneum of the graft, after which the membrane can be removed without rupture of the graft at the recipient site. Thus, healing of the donor site occurs rapidly with minimal discomfort and scar formation.

Because the skin graft in the awarding defect area using the pixel skin graft procedure is pixelated, it provides a gap for drainage between the skin pixel components, thus improving the percentage "engraftment" when compared to sheet skin grafting. During (approximately) the first week after surgery, the skin graft will "engraft" into the donor site by an angiogenic process in which new blood vessels from the recipient site of the skin defect grow into the new skin graft. The semi-porous membrane will conduct the exudate (fluid) into the dressing interior. In addition, the flexible membrane was designed to have elastic recoil properties that promote the adjuvant growth of the component skin pixels within the graft/membrane complex and promote primary adjacent healing of the skin graft pixels, resulting in a uniform sheeting of the pixelated appearance of the skin graft. form can be transformed. Additionally, the membrane aligns the microstructural component skin pixels, whereby the epidermis aligns with the epidermis and the dermis aligns with the dermis, facilitating a primary healing process that reduces scarring. In addition, pixelated skin grafts more readily adapt to irregular donor sites.

Embodiments described herein also include a pixel skin ablation procedure referred to herein as a pixel procedure. For many patients with age-related skin laxity (neck and face, arms, armpits, thighs, knees, buttocks, abdomen, bra line, chest sagging, etc.), partial resection of excess skin can remove significant areas of cosmetic surgery and unavoidable scarring. can be replaced with Generally, the pixel procedure will be performed indoors under local anesthesia. The post-procedure recovery cycle includes wearing a support garment across the treatment area for a predetermined number of (eg, 5, 7, etc.) specified days (eg, 5, 7, etc.). Relatively little or no pain associated with the procedure is expected. By application of the adhesive Flexan® sheet, small (eg 15 mm) circular skin defects will be sutured. When functioning as a large butterfly bandage, the Flexan® sheet is pulled in a direction (“vector”) that maximizes cosmetic contouring of the treatment area. A compression garment is then applied over the dressing to further aid in cosmetic contouring.

After completion of the initial healing phase, a plurality of small linear scars within the treatment area will not be visually apparent. Also, thereafter, the delayed wound healing response will result in additional skin treatment for several months. Therefore, the pixel procedure is a minimally invasive alternative to extensive scarring of cosmetic surgery.

The pixel array medical device of one embodiment includes a PAD kit. 1 illustrates a PAD kit positioned in a target area according to one embodiment. The PAD kit comprises a planar perforated guide plate (guide plate), a scalpel punch or device comprising a scalpel array (Figure 1-3), a backing adhesive membrane or adherent substrate (Figure 4), and a skin pixel dissection blade (Figure 4). 5), but is not limited thereto. The scalp fit punch of an embodiment is a handheld device, but is not limited thereto. A guide plate is optional in an optional embodiment as described herein.

2 is a cross-sectional view of a PAD kit scalpel including an array of scalpels according to an embodiment. A scalpel array includes one or more scalpels. 3 is a partial cross-sectional view of a PAD kit scalpel punch including a scalpit array according to an embodiment; Although the partial cross-sectional view shows that the total length of the scalpels of the scalpel array is determined by the thickness of the perforated guide plate and the depth of incision into the skin, embodiments are not limited thereto.

4 shows a backing adhesive membrane (adhesive substrate) included in a PAD kit according to an embodiment. The underside of the adhesive film is applied to the incised skin in the target area.

5 illustrates an adhesive film (adhesive substrate) in use with a PAD kit frame and blade assembly according to an embodiment. The top side of the adhesive film can be oriented with the adhesive side down inside the frame and pressed over a perforated plate to capture the extruded skin pixels, referred to herein as plugs or skin plugs.

1 , a perforated guide plate is applied to a skin ablation/donor site during a procedure using a PAD kit. The scalp fit punch may be applied through the at least one set of perforations in the perforated guide plate to dissect the skin pixels. When the scalp fit array of punches contains fewer than the total number of perforations in the guide plate, the scalp fit punch is applied multiple times to the plurality of sets of perforations. After one or more successive applications with a scalpel punch, the excised skin pixels or plugs are captured onto the adherent matrix. An adhesive film is then applied in such a way that the adhesive film captures the protruding skin pixels or plugs. By way of example, the top surface of the attachment substrate of an embodiment may be oriented face down inside a frame (when a frame is used) and then compressed over the perforated plate to capture the extruded skin pixels or plugs. As the membrane is pulled upward, the skin pixels captured by the dissection blade are dissected at their base.

6 illustrates the removal of a skin pixel according to an embodiment. The adherent substrate is pulled upwards and posteriorly (to be spaced apart), which serves to lift or pull the incised skin pixel or plug. As the adherent matrix is pulled, an incision blade is used to incise the base of the dissected skin pixel. 7 is a side view of blade incision and removal of an excised skin pixel by a PAD kit according to an embodiment. Pixel collection is completed using an incision at the base of the skin pixel or plug. 8 is an isometric view of blade/pixel interaction during a procedure using a PAD kit according to an embodiment. 9 is during a procedure using a PAD kit (blade removed for clarity) showing both the incised and captured collected skin pixels or plugs and the non-dissected skin pixels or plugs prior to incision, according to one embodiment. Another drawing. At the donor site, the pixelated skin ablation area is sutured by application of a Flexan® sheet.

In addition, guide plates and scalpel devices are used to form skin defects at the donor site. The skin defect is configured to receive collected or captured skin pixels at the donor site. The guide plate used in the donor site may be the same as the guide plate used in the donor site, and may have a different pattern or arrangement of perforations.

During dissection, skin pixels or plugs deposited on the adherent matrix may be transferred from the awarding skin defect area to the skin defect area (donor site) where they can be applied as a pixelated skin graft. The adherent matrix has elastic recoil properties that allow alignment of skin pixels or plugs within the skin graft. The excised skin pixels may be applied directly from the adherent matrix to the skin defect of the donor site. Application of the dissected skin pixel at the donor site includes aligning the dissected skin pixel with the skin defect and inserting the dissected skin pixel into the corresponding skin defect at the donor site.

The pixel array medical device of one embodiment includes a pixel array cortex (PAD). A PAD comprises a planar array of relatively small circular scalpels fixed on a substrate (eg, an investment plate), and the scalpels combined with the substrate are referred to herein as scalpit arrays, pixel arrays or scalpels. 10A is a side view of a portion of a pixel array showing a scalpel secured on an investment plate in accordance with an embodiment. 10B is a side view of a portion of a pixel array showing a scalpel secured on an investment plate in accordance with an alternative embodiment. 10C is a plan view of a scalpel pit according to an embodiment. 10D is a close-up view of a portion of a scalpel in accordance with an embodiment. The scalpel is applied directly to the skin surface. The one or more scalpels of the scalpel array include one or more pointed surfaces, a needle, and a needle comprising a plurality of points.

Embodiments of pixel array medical devices and methods include the use of a collection pattern in place of a guide plate. The collection pattern includes, but is not limited to, an indicator or marker on the skin surface on at least one of the donor site and the donor site. A marker includes any compound that can be applied directly to the skin to mark an area of the skin. A collection pattern is positioned at the donor site, and the scalpel array of the device is aligned with or according to the collection pattern at the donor site. Skin pixels are incised at the donor site with a scalpel fit array as described herein. The donor site is prepared by placing a collection pattern on the donor site. The collection pattern used in the donor site may be the same as the collection pattern used in the donor site, or a different pattern or arrangement of markers may be different. A skin defect is formed and an excised skin pixel is applied to the donor site, as described herein. Optionally, the guide plate of the embodiment is used to apply the collection pattern, but the embodiment is not limited thereto.

To utilize existing surgical instruments, the array of one embodiment is used with, but not limited to, a drum ganglion, such as, but not limited to, Padget ganglia or Reese ganglia. does not The Paget Drum Fizzle referenced herein was developed in the 1930's by Dr. It was developed by Dr Earl Padget and is widely used for skin grafts by plastic surgeons around the world. A Reese deformation of the Paget dermis was then developed to better correct the thickness of the collected skin grafts. The drum puncture in one embodiment is disposable (per procedure), but is not limited thereto.

In general, FIG. 11A shows an example of a rolling pixel drum 100 according to an embodiment. 11B shows one embodiment of a rolling pixel drum 100 assembled on a handle according to an embodiment. More specifically, Fig. 11C shows a drum pit for use with a scalpel in accordance with an embodiment.

In general, for all pixel devices described herein, the geometry of the pixel drum 100 may have various shapes, for example, without limitation, round, semicircular, oval, square, flat sheet, or rectangular. In some embodiments, the pixel drum 100 is supported by an axle/handle assembly 102 and rotates about a drum rotating component 104 powered by, for example, an electric motor. In some embodiments, the pixel drum 100 can be placed on a stand (not shown) when not in use, and the stand can also serve as a battery charger for a motorized rotating component of the drum or a motorized component of a syringe plunger. can function. In some embodiments, a vacuum (not shown) may be applied to the skin surface of the pixel drum 100 , and an outrigger (not shown) may be positioned for tracking and stability of the pixel drum 100 . .

In some embodiments, the pixel drum 100 includes an array of scalpels 106 on the surface of the drum 100 , including a plurality of (eg, 05 to 15 mm) circular, compact, referred to herein as skin plugs. An incision may be formed. In some embodiments, the perimeter geometry of the scalpel may be designed to reduce pin cushioning (“trap door”) while forming a skin plug. Further, the perimeter of each skin plug may also be extended by, for example, but not limited to, semi-circular, oval, or square skin plugs instead of circular skin plugs. In some embodiments, the length of the scalpel 106 may vary depending on the thickness of the skin region selected for the purpose of skin grafting, ie, partial or full.

When the drum 100 is applied to the skin surface, a blade 108 positioned inside the drum 100 cuts the base of each skin plug formed by an array of scalpels, and the inner blade 108 connected to the central drum axle/handle assembly 102 and/or connected to an outrigger bonded to the central axle assembly 102 . In some alternative embodiments, the inner blade 108 is not connected to the drum axle assembly 102 where the base of the incision in the skin is incised. In some embodiments, the inner blade 108 of the pixel drum 100 may vibrate manually or may be powered by an electric motor. Depending on the density of the circular scalpel on the drum, a variable percentage of skin (eg, 20%, 30%, 40%, etc.) can be dissected within the area of excessive skin relaxation.

In some embodiments, an added pixel drum collector 112 is disposed inside the drum 100 to collect dissected/pixelated skin plugs/plugs (pixel grafts) from the tissue of the pixel donor and the pixel drum ( A skin graft operation is performed by aligning it onto the adhesive film 110 lined on the inside of 100). A narrow space is formed between the array of scalpels 106 and the adhesive film 110 to the inner blade 108 .

In an embodiment, the blades 108 are arranged on the outside of the scalpel array 106 and the drum 100 through which the dissected circular skin plug is dissected. In another embodiment, the outer blade 108 is connected to the drum axle assembly 102 when the base of the incision in the skin is incised. In an alternative embodiment, the outer blade 108 is not connected to the drum axle assembly 102 when the base of the incision in the skin is incised. An adhesive film 110 that extracts and aligns the incised skin pieces is then arranged over the patient's skin defect area. Blades 108 (inside or outside) may be, but are not limited to, perforated layers of blades aligned to scalpel array 106 .

When the membrane with the aligned and dissected pieces of skin is extracted from the drum and applied as a skin graft, the conformable adhesive membrane 110 of the embodiment is semi-porous to allow drainage at the awarding skin defect. The adhesive semi-porous drum membrane 110 is also used to route the dissected/pixelated skin plug onto the skin defect area of the recipient, ie, the adhesive membrane with the pixelated graft is extracted from the drum 100. It may then have elastic rebound properties, such that the edges of each skin plug are stitched together as a more uniform sheet. Optionally, the adhesive semi-porous drum membrane 110 can be extended to cover a large surface area of the skin defect area of the recipient. In some embodiments, a sheet of adhesive backer 111 may be applied between the adhesive film 110 and the drum collector 112 . The drum array of scalpels 106 , blades 108 , and adhesive film 110 may be assembled as a sleeve onto an existing drum 100 , as will be described in detail herein.

The inner drum collector 112 of the pixel drum 110 of the embodiment is disposable and replaceable. Restriction and/or control of the use of disposable components may be implemented by means including, but not limited to, electronic, EPROM, mechanical, durable. Electronically and/or mechanically recording and/or limiting the number of drum revolutions for the disposable drum and also the usage time for the disposable drum may be electronically or mechanically recorded, controlled and/or limited.

During the collection portion of the procedure with drum dermis, the PAD scalpel array is applied directly to the skin surface. To circumferentially dissect a skin pixel, the drum dermis is placed over the scalpel pit array, applying a load to the skin surface below it. Under sustained load, the excised skin pixels are extruded through the holes of the scalpel pit array and captured on the adhesive film on the drum nodule. Incision of the dermis An outrigger blade (placed over the scalpelpit array) incises the base of the extruded skin pixels. The membrane and pixelated skin complex are then removed from the dermal drum and applied directly to the awarding skin defect as a skin graft.

Referring to FIG. 11C , an embodiment includes a drum pit for use with a scalpel, as described herein. More specifically, FIG. 12A shows a drum pit disposed over a scalpel under one embodiment. 12B is an optional view of a drum crust disposed over a scalpel in accordance with an embodiment. The incising outrigger blades of the drum skin are placed on top of the scalpel pit array, where extruded skin plugs will be incised at their base.

FIG. 13A is an isometric view of application of a drum lice (eg, a Paget fission) over a scalpel, in which, according to one embodiment, the adhesive film is applied to the drum of the fission prior to being rolled over an investment plate. 13B is a side view of a portion of a drum segment showing the blade position relative to the scalpel, under one embodiment. 13C is a side view of a portion of a drum pit showing a blade position different from a scalpel in accordance with one embodiment. 13D is a side view of a drum slice with another blade position relative to the scalpel, according to one embodiment. 13E is a side view of a drum dermis with an incision blade clip, showing incision of a skin pixel by the blade clip, according to one embodiment. 13F is a bottom view of a drum pit including a scalpel, according to an embodiment. 13G is a front view of a drum pit including a scalpel, according to an embodiment. 13H is a rear view of a drum pit including a scalpel in accordance with one embodiment. Depending on the clinical application, a disposable adhesive film of drum dermis will be used for deposition/removal of ablated flaccid skin or collection/alignment of pixelated skin grafts.

Embodiments described herein also include Pixel Onlay Sleeves (POS) for use with ligaments, eg, Paget Fissures and Liz Fisions.

14A shows an assembled view of a skin graft including a pixel onlay sleeve (POS) according to an embodiment. The POS comprises an adhesive backer, an adhesive, and a crust and blade comprising an array of scalpels. The adhesive backer, adhesive, and scalpel array are integral to, but are not limited to, the device.

14B is an exploded view of a pterygoid with a pixel onlay sleeve (POS) according to an embodiment. 14C illustrates a portion of a ligament with a pixel onlay sleeve (POS), according to one embodiment.

POS, referred to herein as "sleeve", provides a disposable drum skin graft onlay for partial excision of excessively flaccid skin and partial skin grafting of skin defects. The onlay sleeve is used in conjunction with one of a paget and a pizzel as a disposable component. The POS of the embodiment is a three-sided slip-on disposable sleeve that slides over the drum sheath. The apparatus includes an array of scalpel pit drums having an adhesive membrane and an inner cutting blade. The cutting blade according to an embodiment includes a cross-sectional cutting surface that sweeps across the inner surface of the scalpel drum array.

In an optional blade embodiment, a fenestrated cutting layer covers the inner surface of the scalpel pit array. Each perforation with a cutting surface is aligned with a respective individual scalpel. Instead of a sweeping action to incise the base of the skin plug, the perforated incision layer vibrates over the scalpel pit drum array. A narrow space is formed between the adhesive film and the scalpel pit array for blade movement. For collection of multiples during a skin graft procedure, an insertion slot for an additional adhesive membrane is provided. The protective layer over the adhesive film is peeled in place using an extended extraction tab pulled from an extraction slot on the opposite side of the sleeve assembly. In another pixel device embodiment, the adhesive film is semi-porous for release in the awarding skin defect area. To change the pixelated skin graft into a more continuous sheet, and also to provide closer alignment of skin plugs within the skin graft, the membrane may have elastic recoil properties.

Embodiments described herein include a slip-on PAD that is configured as a disposable device comprising a pagett or liz fission. 15A shows a slip-on PAD sliding onto a Paget drum crust according to one embodiment. 15B shows an assembled view of a slip-on PAD installed on a Paget drum crust in accordance with one embodiment.

The slip-on PAD of the embodiment is (optionally) used in combination with a perforated guide plate. 16A depicts a slip-on PAD installed over a Paget drum crust and used with a perforated template or guide plate according to an embodiment. A perforated guide plate may be placed over the target skin area and secured in place by an adhesive on the lower surface of an apron to maintain orientation. A Paget dermis containing a slip-on PAD is rolled over a perforated guide plate on the skin.

16B depicts skin pixel collection using a Paget drum dermabrasion and an installed slip-on PAD according to an embodiment. For skin pixel collection, the slip-on PAD is removed, adhesive tape is applied over the drum of the Paget dermis, and a clip-on blade is installed on the outrigger arm of the dermis, followed by incision at the base of the skin pixel. used In addition, the slip-on PAD of the embodiment is optionally used with standard surgical instruments, such as a ribbon retractor to protect the adjacent skin of the donor site.

An embodiment of the pixel instrument described herein includes a Pixel Drum segment (PD2), which is a disposable instrument or device. The PD2 comprises a cylindrical or rolling/rotating drum coupled to a handle, the cylinder comprising an array of scalpel-pit drums. The inner blades are interlocked to the drum axle/handle assembly and/or to the outriggers glued to the center axle. Using the PAD and POS described herein, multiple mini-pixelated ablations of the skin are performed directly within the skin relaxation area, thereby improving skin treatment with minimal visual scarring.

17A shows an example of a pixel drum dermis applied to a target area of a skin surface in accordance with one embodiment.

17B illustrates a portion of a pixel drum dermis applied to a target area of a skin surface in accordance with one embodiment.

The PD2 device applies a full rolling/rotating drum to the skin surface where a plurality of small (eg 15 mm) circular incisions are formed in the target area according to a “scalpit drum array”. The base of each skin plug is then cut using an inner blade that interlocks with the central drum axle/handle assembly and/or interlocks with the outriggers attached to the central axle. Depending on the density of circular scalpels on the drum, a variable percentage of skin can be ablated. Although a portion of the superficial area of the skin (eg, 20%, 30%, 40%, etc.) according to PD2 may be ablated without visual scarring in the excessive skin relaxation area, embodiments are not limited thereto.

Another embodiment of the pixel mechanism presented herein is the Pixel Drum Harvester (PDH). Similar to the pixel drum dermis, an added inner drum collects the pixelated resection of the skin and aligns the resection onto an adhesive membrane, which is then placed over the patient's awarding skin defect area. The conformal adhesive membrane is semi-porous to allow release at the awarding skin defect when the membrane with the aligned and dissected skin pieces is extracted from the drum and applied as a skin graft. Depending on the elastic recoil properties of the membrane, the pixelated skin pieces are brought closer together so that the pixelated skin graft is partially converted from the donor to a sheet graft.

The pixel array medical systems, devices or devices and methods described herein may enable or cause cellular and/or extracellular responses essential to the implemented clinical outcome. In the case of pixelated dermis, a physical reduction in the surface area of the skin occurs due to pixelated ablation of the skin, ie the formation of a skin plug. Additionally, a delayed wound healing response results in subsequent skin treatment. Each pixelated ablation initiates a wound healing sequence in multiple steps as detailed herein.

The first step in this sequence is the inflammatory phase, where degranulation of mast cells releases histamine to the "wound". Histamine secretion can cause dilatation of the capillary system and increase vessel permeability into the extracellular space. This initial wound healing reaction occurs on the first day and will appear as erythema on the surface of the skin.

The second stage (fibroproliferation) is initiated within 3 to 4 days after "wound formation". During this phase, fibroblast migration and mitotic proliferation are present. Wound fibrosis involves the deposition of neocollagen and myofibroblast contraction of the wound.

Histologically, neocollagen deposition can be microscopically confirmed as shrinkage and thickening of the dermis. Although this is a static process, the tensile strength of the wound is significantly increased. Another characteristic feature of fibroproliferation is the dynamic physical process that results in multidimensional contraction of the wound. This feature of fibrosis is due to active cell contraction of myofibroblasts. Morphologically, the myoblast contraction of the wound will be visualized as a two-dimensional treatment of the skin surface. Collectively, the effect of fibroproliferation is dermal contraction with deposition of a static support scaffold of neocollagen with the treated framework. Clinical effects are shown as delayed treatment of skin with smooth skin texture for several months. In general, the clinical goal is a younger looking skin film in the treatment area.

The third and final stage of the delayed wound healing response is the maturation stage. During this phase, strengthening and remodeling of the treatment area is provided due to increased cross-linking of the collagen myofibril matrix (in the dermal). This final stage begins within 6 to 12 months after "wound formation" and may extend for at least 1 to 2 years. Miniature pixelated resections of the skin should preserve the normal dermal structure during this delayed wound healing process, without the formation of obvious scars typically caused by larger surgical resections of the skin. Finally, associated stimulation and rejuvenation of the epidermis by secretion of epidermal growth hormone occurs. A delayed wound healing response can be induced with scar collagen deposition in tissues (eg, muscle or fat) with minimal pre-existing collagen matrix.

In addition to treating skin for cosmetic purposes, the pixel array medical systems, devices or devices and methods described herein may have additional medical related applications. In some embodiments, the pixel array device is capable of ablating a degenerative portion of any soft tissue structure without resorting to standard surgical resection. More specifically, reduction of actinic damaged areas of skin through pixel array devices should reduce the incidence of skin cancer. For the treatment of sleep apnea and snoring, pixelated mucosal reduction (soft palate, tongue muscle, and temporal wall) via pixel array devices will reduce the significant morbidity associated with more standardized surgical procedures. . In the case of labor injury of the vaginal fornix, pixelated skin and vaginal mucosal ablation via the pixel array device will reconstruct the normal pre-partum morphology and function without the aid of A&P ablation. Associated female stress incontinence can also be corrected in a similar manner.

The pixel array fission (PAD) of an embodiment, also referred to herein as a scalpel device assembly, comprises a system or kit comprising a control device, referred to as a punch impact handpiece, and a scalpel device, referred to as a tip device. A scalpel device removably coupled to the control device includes an array of scalpels disposed within the scalpel device. The removable scalpel device of an embodiment is disposable and is configured for use during a single procedure, although the embodiment is not so limited.

A PAD includes a device that includes a housing configured to contain a scalpel device. The scalpel device includes a substrate and an array of scalpels, wherein the array of scalpels includes a plurality of scalpels arranged on the substrate. The substrate and the plurality of scalpels are configured to deploy from and retract into the housing, and the plurality of scalpels are configured to, upon deployment, form a plurality of ablated skin pixels in the target area. The proximal end of the control device is configured to be hand-held. The housing is configured to be removably coupled to a receiver that is a component of the control device. The control device includes a distal end comprising a receptacle and a proximal end comprising an actuator mechanism. The control device is disposable but optionally the control device is configured to be at least one of cleaning, disinfecting and sterilizing.

The scalpel array is configured to deploy in response to actuation of the actuator mechanism. The scalpel device of an embodiment is configured such that the scalpel array is deployed from the scalpel device and retracted into the scalpel device in response to actuation of an actuator mechanism. An alternative embodiment of the scalpel device is configured such that the calfit array deploys from the scalpel device in response to actuation of the actuator mechanism and retracts into the scalpel device in response to release of the actuator mechanism.

18 shows a side perspective view of a PAD assembly according to an embodiment. The PAD assembly of this embodiment includes a scalpel device comprising an array of scalpels and a control device configured to be hand-held comprising an actuator or trigger. Although the control device is reusable, an alternative embodiment includes a disposable control device. The scalpel array of an embodiment is configured to form or form an array of incisions (eg, 15 mm, 2 mm, 3 mm, etc.) as detailed herein. Embodiments of the scalpel device include, but are not limited to, a spring-loaded array of scalpels configured to incise skin as described in detail herein.

19A shows a top perspective view of a scalpelfit device for use with a PAD assembly according to an embodiment. 19B shows a bottom perspective view of a scalpelfit device for use with a PAD assembly according to an embodiment. The scalpel device includes a housing coupled to the plunger or configured to receive a substrate comprising the same. The housing is configured such that a proximal end of the plunger protrudes through an upper surface of the housing. The housing is removably coupled to the control device and the length of the plunger is configured to protrude spaced apart through the upper surface for contacting the actuator and control device when the scalpel device is coupled to the control device.

The substrate of the scalpel device is configured to hold a plurality of scalpels forming an array of scalpels. The scalpel array includes a predetermined number of scalpels as suitable for the procedure in which the scalpel device assembly is used. The scalpelfit device includes one or more spring mechanisms configured to provide a downward, or impact, or punching force in response to actuation of the scalpit array device, the force being applied to an incision (on a pixelated skin plug) by the scalpelpit array. helps in the formation of Optionally, the spring mechanism may be configured to provide an upward or retractive force to assist in retraction of the scalpel array. One or more scalpit devices and control devices of an embodiment include an encryption system (eg, EPROM, etc.). The encryption system is configured to prevent, but is not limited to, fraudulent use and piracy of the scalpel device and/or control device.

During the procedure, the scalpel device assembly is applied to the target area once or, optionally, successively within a designated target treatment area of skin relaxation. The pixelated skin ablation areas within the treatment area are then sutured upon application of a Flexan sheet as detailed herein, and directional suturing of these pixelated resections is performed in an orientation that provides maximum aesthetic correction of the treatment area.

An alternative embodiment of the PAD device includes a vibrating component or system for removing ablated skin pixels. 20 shows a side view of a punch percussion device including a vibrating component according to an embodiment; The PAD of this example includes, but is not limited to, a vacuum system or component within the control device for aspiration ablation of dissected skin pixels. The vibrating component is removably coupled to the PAD device and its use is optional. The vibrating component is coupled and configured to form a low-pressure zone within or adjacent to one or more of the housing, the scalpel device, the scalpel array, and the control device. The low-pressure zone is configured to ablate the dissected skin pixels.

[0134] Another alternative embodiment of the PAD device includes a radio frequency (RF) component or system for forming skin pixels. The RF component is coupled and configured thereto for providing energy in or adjacent to one or more of the housing, the scalpel device, the scalpel array, and the control device. The RF component is removably coupled to the PAD device and its use is optional. The energy provided by the RF component includes one or more of thermal energy, vibrational energy, rotational energy, and acoustic energy.

Another alternative embodiment of the PAD device includes a vibrating component or system and an RF component or system. The PAD of this embodiment includes a vacuum system or component within the handpiece to aspirate the dissected skin pixels. The vibrating component is coupled and configured to form a low-pressure zone within or adjacent to one or more of the housing, the scalpel device, the scalpel array, and the control device. The low-pressure zone is configured to ablate the dissected skin pixels. Additionally, the PAD device includes an RF component coupled to and configured to provide energy within or adjacent to one or more of the housing, the scalpel device, the scalpel array, and the control device. The RF component is removably coupled to the PAD device and its use is optional. The energy provided by the RF component includes one or more of thermal energy, vibrational energy, rotational energy, and acoustic energy.

As one specific example, the PAD of an embodiment includes an electrosurgical generator configured to more effectively dissect a donor skin or skin plug with minimal heat-conducting damage to adjacent skin. For this reason, RF formers are operated using relatively high power levels, for example with relatively short duty cycles. The RF former is configured to provide one or more of a motorized impactor component, a cycling impactor, a motorized impactor, and an ultrasonic transducer configured to provide an additional compressive force for ablation.

The PAD with RF of this example includes a vibrating component as described herein. The PAD with RF of this example also includes a vibrating component as described herein. The vibrating component of this embodiment is configured to apply a vacuum that pulls the skin towards the scalpel (eg, into the lumen of the scalpel, etc.) to stabilize and facilitate RF-mediated dissection of the skin in the partial ablation area, but is not limited thereto. doesn't happen One or more of the RF former and the vacuum device are coupled under the control of a processor running the software application. Additionally, the PAD of this embodiment may be used with, but not limited to, guide plates as detailed herein. In addition to partial incisions at the donor site, partial skin grafting involves the collection and deposition of skin plugs for delivery to the donor site (eg, onto an adhesive membrane, etc.) Depending on the portion of the skin excision, RF on an array of scalpels Use of the incision edge involves the incision of a donor skin plug. The base of the dissected scalpel is then dissected and collected as described herein.

The timing of the vacuum assist component is processor controlled to provide a predetermined sequence according to the RF duty cycle. Depending on the software control, various changes are possible to provide an optimal sequence of RF ablation in combination with vacuum assistance. Without limitation, this includes an initial vacuum period prior to the RF duty cycle. After the RF duty cycle, a period in the sequence of embodiments includes suction extraction of the incised skin plug.

Other potential control sequences of the PAD include, without limitation, the simultaneous duty cycle of RF and vacuum assist. Optionally, the sequence of embodiments includes the use of a former at different RF frequencies or changes in RF power and/or pulsing or cycling of RF duty cycles within the sequence.

Another optional control sequence includes a designated RF cycle occurring at the depth of the partial incision. Depending on the insulating shaft, the lower the power, the longer the RF duty cycle duration, and the active dissection tip can cause heat-conduction injury to the deep skin/subcutaneous tissue interface. Deep thermal injury can lead to a delayed wound healing sequence that heals the skin secondarily without burning the skin surface.

Depending on the software control, various changes are possible to provide an optimal sequence of vacuum-assisted combined RF ablation and electromechanical ablation. Examples include, but are not limited to, combinations of electromechanical ablation with vacuum assisted, electromechanical ablation and RF ablation with vacuum assisted, RF ablation with vacuum assisted, and RF assisted with vacuum. Examples of combined software controlled duty cycles are: precut vacuum skin stabilization period, RF incision duty cycle according to vacuum skin stabilization period, RF incision duty cycle according to vacuum skin stabilization and motorized machine incision period, motorized machine according to vacuum skin stabilization period incision, post-incision RF duty cycle for thermally conductive heating of deeper skin and/or subcutaneous tissue layers to elicit a wound healing response to skin treatment, and post-incision vacuum excision period for skin treatment.

Another embodiment of the pixel array medical device described herein is a device that is used for skin treatment as an alternative to the drum/cylinder described herein and includes an electrically powered or manually deployed (non-motorized) vibrating planar scalpel array and blades. includes 21A is a top view of a vibrating plane scalpel array and blade arrangement according to an embodiment; 21B is a bottom view of a vibrating plane scalpel array and blade arrangement according to an embodiment. The blade 108 may be a perforated layer of blades aligned with the scalpel pit array 106 . The instrument handle 102 is separated from the blade handle 103 and the adhesive film 110 can be peeled off the adhesive backer 111 . 21C is a close-up view of a planar array when the array of scalpels 106, blades 108, adhesive film 110, and adhesive backer 111 are assembled together according to an embodiment. As assembled, the planar array of scalpels may be metered to provide uniform collection or uniform ablation. In some embodiments, the planar array of scalpels comprises an adhesive collection membrane 110 and an adhesive backer 111 ) for a feeder component (feeder component, 115) may be further included. 21D is a close-up view of a planar array of scalpels with a feeder component 115 in accordance with an embodiment.

In another skin graft embodiment, the pixel graft is disposed on an irradiated cadaveric dermal matrix (not shown). When cultured on a dermal matrix, a full-thickness skin graft is formed for a patient immunologically identical to the pixel donor. In an embodiment, the cadaveric dermal matrix is also cylindrically incised to a size similar to the size of the collected skin pixelated grafts to provide histological alignment of the pixelated grafts into the cadaveric dermal framework. 22 depicts a cadaveric dermal matrix with a cylindrical incision similar in size to that of a skin pixel graft collected in accordance with an embodiment. In some embodiments, the percentage of collection of the donor site may be determined by introduction of normal dermal histology in the skin defect area of the recipient, ie, facilitating a normal (smooth) surface topology of the skin graft. That is, the normal (smooth) surface topology of the skin is promoted. With respect to the adhesive membrane or dermal matrix embodiments, the pixel drum collector includes the ability to collect large surface areas for implantation with significant reduction or elimination of visual scarring of the patient's donor site.

In addition to the pixel array medical devices described herein, embodiments include a drug delivery device. In most cases, parenteral delivery of drugs is realized from injection by syringe and needle. To rule out the negative features of needle and syringe systems, topical absorption of drugs percutaneously via an occlusive patch has been developed. However, both of these drug delivery systems have significant drawbacks. Human aversion to needle injection has not diminished in use over nearly two centuries. Variable systemic absorption of subcutaneous or intramuscular drug injections can reduce drug effectiveness and increase the incidence of undesirable patient reactions.

Depending on the oily or aqueous carrier fluid of the drug, topically applied occlusive patches with variable absorption across the epidermal barrier can be challenging. Neither syringe/needle injection nor local anesthesia is ideal for patients requiring local anesthesia over large surface areas of the skin. Syringe/needle "field" injections are often painful and can administer an excess of local anesthetic which can cause systemic toxicity. Local anesthesia is difficult to provide the required level of anesthesia for skin related procedures.

23 is a drum array drug delivery device 200 according to an embodiment. The drug delivery device 200 successfully addresses the limitations and disadvantages of other drug delivery systems. The apparatus includes a drum/cylinder 202 supported by an axle/handle assembly 204 and rotating about a drum rotating component 206 . The handle assembly 204 of an embodiment further includes a reservoir 208 of the drug to be delivered and a syringe plunger 210 . The surface of the drum 202 is covered by an array of needles 212 of uniform length, providing a uniform intradermal (or subcutaneous) injection depth into the skin of the patient, whereby a more controlled amount of drug is administered. It is injected into the patient's skin. In operation, the syringe plunger 210 presses the drug from the reservoir 208 , whereby the drug is injected through the connecting tube 216 into the sealed injection chamber 214 in the drum 202 . The drug is delivered to the patient's skin at a uniform depth as the array of needles 212 is pushed into the patient's skin until the surface of the drum 202 is finally in contact with the skin. Non-anesthetized skip areas are avoided and a more uniform pattern of skin anesthesia is formed. Also, the rolling drum application of the drug delivery device 200 administers the local anesthetic more quickly with less patient discomfort.

24A is a side view of a needle array drug delivery device 300 according to one embodiment. 24B is a top isometric view of a needle array drug delivery device 300 according to one embodiment. 24C is a bottom isometric view of a needle array drug delivery device 300 according to one embodiment. The drug delivery device 300 includes a planar array of microneedles 312 of uniform length disposed on a manifold 310 that can be used for drug delivery. In this exemplary embodiment, a syringe 302 containing a medicament for injection may be fitted with a disposable adapter 306 having a handle, wherein the syringe 302 and the disposable adapter 306 are fixedly coupled to each other. A seal 308 may be used to ensure that When the syringe plunger 304 is pushed, the drug contained within the syringe 302 is delivered from the syringe 302 to the disposable adapter 306 . As the array of needles 312 is pushed into the patient's skin until the manifold 310 makes contact with the skin, the drug is further pushed through the planar array of microneedles 312 into the patient's skin at a uniform depth. is transmitted

The use of the drug delivery device 200 may have as many clinical applications as the number of drugs requiring transdermal injection or absorption. By way of non-limiting example, some of the possible applications are injections of local anesthetics, injections of neuromodulators such as Botulinum toxin (Botox), injections of insulin and injections of replacement estrogens and corticosteroids. .

In some embodiments, the syringe plunger 210 of the drug delivery device 200 may be powered by an electric motor as a non-limiting example. In some embodiments, a fluid pump (not shown) attached to the IV bag and tube may be connected to the injection chamber 214 and/or the reservoir 208 for continuous injection. In some embodiments, the volume of the syringe plunger 210 within the drug delivery device 200 may be calibrated and programmed.

Another application of pixel skin graft collection using a PAD (Pixel Array Dermal) device as described herein is alopecia. Alopecia is a common cosmetic ailment, which occurs most frequently among middle-aged men, but is also found in baby boomer women. The most common form of alopecia is baldness (Male Pattern Baldness, MPB) occurring in the fronto-parietal region of the scalp. Male pattern baldness is a sex-linked attribute transmitted by the X chromosome from the mother. For males, only one gene needs to display this phenotype. Because the gene is recessive, female pattern baldness requires the transfer of both X-linked genes from both mother and father. The degree of phenotypic penetration can vary from patient to patient, and is most frequently indicated by the amount and age of onset of frontal/partial/occipital hair loss. Patient variability The phenotypic expression of MPB due to variable phenotypic transformation of this sex-associated attribute. With the phenotypic development of MPB, the need for hair transplantation is significant. Other non-genetically related etiologies are seen in a more limited subset of the population. These non-genetic etiologies include trauma, fungal infection, lupus erythematosus, radiation therapy and chemotherapy.

Various treatment options have been proposed to the public. This includes FDA-approved topical drugs such as Minoxidil and Finasteride, which have had limited success because these substances require the transformation of resting hair follicles to a growth stage. Other remedies include partial wigs and hair weaving. Standard of this practice is in surgical hair transplantation, which involves the transfer of hair plugs, strips and flaps from the hairy scalp to the hairless scalp. In most cases, conventional hair transplantation involves the transfer of a plurality of single hair micrographs from the hairy scalp to the hairless scalp of the same patient. Optionally, the donor plug is initially collected into a hair strip and then micrographed for secondary delivery to the recipient scalp. Regardless, this multi-step procedure takes several hours of surgery for the average patient, which is tedious and expensive.

The conventional hair transplant market is complicated by the long hair transplant procedure performed in multiple steps. A typical hair transplant procedure involves the delivery of a hair plug from the donor site in the occipital scalp to the donor site of the fronto-parietal scalp, which is beginning to peel off. For most procedures, each hair plug is delivered individually to the recipient scalp. Hundreds of plugs can be implanted during a procedure that needs to be performed for hours. Post-procedural "engraftment" or viability of implanted hair plugs is variable due to factors limiting neovascularization at the donor site. Bleeding and mechanical rupture due to movement are major factors in reducing "engraftment" and neovascularization of hair transplantation.

Embodiments described herein include surgical instruments configured to deliver a plurality of scalp grafts when aligned and secured at a donor site on the scalp. The procedure described herein reduces the time and tedium required by conventional apparatus. 25 shows the tissue of human skin. The skin comprises two horizontal lamellar layers called the epidermis and the dermis, which function as a biological barrier to the external environment. The epidermis is the epidermal layer and contains a viable layer of epidermal cells that “form” and migrate upward into a non-viable layer called the stratum corneum. The stratum corneum is a lipid-keratin complex that serves as the primary biological barrier, and this layer is continuously exfoliated and reconstituted in a process called exfoliation. The dermis is the underlying layer that is the main structural support of the skin, is predominantly extracellular and consists of collagen fibers.

In addition to the horizontally stratified epidermis and dermis, the skin contains vertically aligned elements or cellular appendages, including sebaceous gland units, which include hair follicles and sebaceous glands. sebaceous glands and hair follicles, respectively. The sebaceous gland is the outermost and discharges sebum (oil) into the axis of the pores. The base of the pore is called the bulb, and the base of the bulb has a deep regeneration area called the dermal papilla. The pores are typically aligned at an angle to the skin surface. In a given area of the scalp, the pores are aligned parallel to each other. Although sebaceous gland units are common throughout the entire skin, the density and activity of these units within the area of the scalp is a major determinant of the overall appearance of the hair.

In addition to the sebaceous gland units, sweat glands also run vertically through the skin. It is a water-based leak that aids in thermoregulation. Apocrine sweat glands in the armpits and groin are the more nasally irritating sweats that produce body odor. For the rest of the body, the secretory glands secrete less irritating sweat to help regulate body temperature. The pores progress through different physiological cycles of hair growth.

26 shows the physiological cycle of hair growth. The presence of testosterone in a genetically-prone man will cause hair loss to varying degrees in the fronto-parietal scalp. Substantially, hair follicles are not activated by entering the telogen phase without returning to the anagen phase. Male pattern baldness occurs when hair does not return from telogen to anagen.

According to an embodiment of the PAD, population collection of hairy plugs using population transplantation from hairy plugs to hairless scalps will significantly reduce the conventional surgical procedure of hair transplantation. In general, the devices, systems and/or methods of the embodiments are used to collect and align many plugs with small hairs in a single surgical step or procedure, the same instrument being used to perform multiple pixelated incisions of the hair-free scalp by Used to prepare donors. A plurality of hair-plug implants are delivered to the prepared recipient area and transplanted into the population. Thus, through the use of streamlined procedures, hundreds of hairy plugs can be transferred from donor to donor. Thus, hair transplantation using the embodiments described herein provides a solution that is easy, simple and significantly time-saving compared to the tedious, multi-step conventional process.

The hair transplantation using the pixyl node of the embodiment helps to improve the conventional standard follicular unit extraction (FUT) hair transplantation method. In general, the pores collected under the procedure of the Examples are taken from the occipital scalp of the donor. Accordingly, the donor hair is partially shaved, and the perforated plate of the embodiment is positioned and oriented on the scalp to provide maximum collection. 27 depicts collection of donor hair follicles according to an embodiment. The scalpels in the scalpel array are configured to penetrate under the subcutaneous fat to trap pores. Once the hair plug is incised, they are collected into an adhesive film by incising the base of the hair plug with an incision blade as detailed herein. The original alignment of the hair plugs with respect to each other at the donor site is maintained by applying an adhesive film prior to incision at the base. Thereafter, the aligned stroma of the hair plug on the adhesive membrane will be implanted in the donor site on the recipient's fronto-parietal scalp.

28 illustrates the preparation of a donor site according to an embodiment. The donor site is prepared by excision of the hairless skin plug in a topographically identical pattern to the collected occipital scalp donor site. According to an embodiment, the donor site is prepared for mass transplantation of the hair plug using the same instrument used in the donor site, and accordingly, a scalp defect is formed in the donor site. The scalp defect formed at the donor site has the same geometry as the collected plug on the adhesive film.

The adhesive film with the collected hair plug is applied according to the same pattern of the scalp defect at the donor site. Per row, each hairy plug is inserted into a mirror image awarding defect. 29 depicts a disposition of a hair plug collected at a donor site according to one embodiment. The plug-to-plug alignment is maintained so that the hair transplanted from the hair plug grows naturally as if it had grown at the donor site. This will result in a more even alignment between the original scalp and the transplanted hair.

More specifically, the donor hair is partially shaved to prepare for placement or placement of the perforated plate on the scalp. A perforated plate is arranged on the occipital scalp donor to provide maximum collection. 30 depicts the placement of a perforated plate on an occipital scalp donor according to an embodiment. Collective collection of hair plugs is implemented using a spring-loaded pixelating device comprising an impact punch hand piece with a scalpel-fit disposable tip. Embodiments are configured for collection of individual hair plugs using an off-the-shelf FUE extraction device or biopsy punch, wherein the holes in the perforated plate are sized to allow for existing techniques.

Scalpits comprising a Scalpit Array disposable tip are configured to penetrate under the subcutaneous fat to trap pores.

31 illustrates the depth of scalp pit penetration through the skin when the scalp pit is configured to penetrate into the subcutaneous fat layer to entrap pores in accordance with an embodiment. Once the hair plug is incised, they are collected, but not limited to, into an adhesive film by incising the base of the hair plug with an incision blade. 32 illustrates hair plug collection using a perforated plate at a laryngeal donor site according to an embodiment. The original alignment of the hair plugs with respect to each other is maintained by applying the adhesive film of the embodiment. An adhesive film is applied prior to excising the base of the ablated pixel and the embodiment is not limited thereto. The aligned stroma of the hair plug on the adhesive membrane is then implanted into the donor site on the fronto-parietal scalp.

Additional single hair plugs may be collected, for example, through a perforated plate used to form a visible hairline. 33 illustrates the formation of a visible hairline according to an embodiment. A visible hairline is determined and formed using a manual FUT technique. Population transplantation of visible hairline and parietal can be performed as separate steps or simultaneously. When the visible hairline and population transplantation are performed simultaneously, a donor site is formed starting from the visible hairline.

Implantation of the collected hair plug is prepared by excision of the hairless skin plug in a topographically identical pattern to the collected occipital scalp donor site. 34 illustrates the preparation of a donor site using a spring-loaded pixelated device and a patterned perforated plate to form identical skin defects in the donor site according to an embodiment. The donor site of the embodiment is prepared for population implantation of hair plugs using the same perforated plate and spring-loaded pixelated device used in the donor site. A scalp defect is formed in the awarding tract. These scalp defects have the same geometry as the collected plugs on the adhesive film.

The adhesive film with the collected hair plug is applied according to the same pattern of the scalp defect at the donor site. Per row, each hairy plug is inserted into its mirror image awarding defect. 35 illustrates implantation of a collected plug by inserting the collected plug into a corresponding skin defect formed at a donor site according to one embodiment. The plug-to-plug alignment is maintained so that hair growing from the implanted hair plug grows naturally as if it had grown at the donor site. This will result in a more even alignment between the original scalp and the transplanted hair.

Clinical goals vary from patient to patient, but a high percentage of hair plugs will "engraft" as a result of improved neovascularization. 36 depicts clinical objectives using a pixel cleavage instrument and procedure according to an embodiment.

According to the combination of better "engraftment", shorter procedure time, and more natural looking results, the pixel ablation apparatus and procedure of the embodiment overcome the shortcomings in conventional hair transplantation methods.

Embodiments of pixelated skin excision for skin relaxation and pixelated skin grafting for skin defects are described in detail herein. These embodiments remove areas of skin pixels in areas of flaccid skin in need of skin treatment. The skin defects formed by this procedure (eg, in the range of approximately 15-3 mm diameter) are small enough to be treated primarily without visual scarring, and wound closure of multiple skin defects is required to form the desired contouring effect. performed directionally. Live animal experiments of the pixel ablation procedure have yielded excellent results.

The pixel procedure of the embodiment is performed in an office environment under local anesthesia, but is not limited thereto. The physician uses the instrument of the embodiment to rapidly ablate an array of skin pixels (eg, circular, oval, square, etc.). Relatively little pain is caused during this procedure. The intradermal skin defect formed during the procedure is closed by application of an adhesive Flexan (3M) sheet, but the embodiment is not limited thereto. When functioning as a large butterfly bandage, the Flexan sheet is pulled in a direction that maximizes cosmetic contouring of the treatment area. A compression garment is then applied over the dressing to further aid in cosmetic contouring. During recovery, the patient wears a support garment over the treatment area for a period of time (eg, 5 days, etc.). After the initial healing phase is completed, multiple small linear scars within the treatment area are not significantly visible.

Additional skin treatment will thereafter develop over several months from the delayed skin healing response. Thus, the pixel procedure is a minimally invasive alternative for skin treatment in areas where extensive scarring of conventional plastic surgery is avoided.

The pixel procedure elicits cellular and extracellular responses that are embodied clinical outcomes. The physical reduction of the skin surface area results from partial ablation of the skin, which physically removes a portion of the skin directly in the relaxation area. Additionally, subsequent treatment of the skin is realized from a delayed wound healing response. Each pixelated ablation initiates a wound healing sequence. The healing response disclosed in the Examples comprises three steps as described in detail hereinabove.

The first step in this sequence is the inflammatory phase, where degranulation of mast cells releases histamine to the "wound". Histamine secretion can cause dilatation of the capillary system and increase vascular permeability into the extracellular space. This initial wound healing reaction occurs on the first day and will appear as erythema on the surface of the skin.

During “wound formation”, a second healing phase, fibroproliferation, is initiated. During fibrosis there is migration of fibroblasts and mitotic proliferation.

Fibroplasty has two main features: neocollagen deposition and myoblast contraction of the wound. Histologically, neocollagen deposition can be microscopically confirmed as shrinkage and thickening of the dermis. Although this is a static process, the tensile strength of the wound is significantly increased. Myoblast contraction is a dynamic physical process that results in a two-dimensional treatment of the skin surface. This process is due to the deposition of contractile proteins in the extracellular matrix and active cell contraction of myoblasts. Collectively, the effect of fibroproliferation is dermal contraction with deposition of a static support scaffold of neocollagen with the treated framework. Clinical effects are shown as delayed treatment of skin with smooth skin texture for several months. The clinical goal is a younger looking skin film in the treatment area.

The third and final stage of the delayed wound healing response is the maturation stage. During this phase, strengthening and remodeling of the treatment area is provided due to increased cross-linking of the collagen myofibril matrix (in the dermal). This final stage begins within 6 to 12 months after "wound formation" and may extend for at least 1 to 2 years. Miniature pixelated resections of the skin should preserve the normal dermal structure during this maturation, without the formation of visually apparent scars typically caused by larger surgical resections of the skin. Finally, associated stimulation and rejuvenation of the epidermis by secretion of epidermal growth hormone occurs.

37-42 show images formed from pixel procedures performed on a live animal according to an embodiment. The examples described herein are used in this proof-of-concept study in an animal model confirming that the pixel procedure results in cosmetic skin treatment without visual scarring. The study was used in a live pig model anesthetized for this procedure. 37 is an image of skin marked at the midpoint and edge of an ablated area according to an embodiment. The area edge of the resection is demarcated with a tattoo for post-surgical evaluation, although embodiments are not limited thereto. The procedure is performed using a perforated plate (eg, a 10x10 pixel array) to designate an area for partial ablation. Subdivision was performed using a biopsy punch (eg, 15 mm diameter). 38 is an image of a post-surgery skin ablation area according to an embodiment. After the pixel section, the pixelated ablation defect is closed (in the horizontal direction) using a Flexan membrane.

On day 11 post-procedure, all incisions are treated primarily in the area designated by the tattoo and photographic and dimension measurements are performed. 39 depicts an image at day 11 post procedure showing a primary treated resection with measured edges according to an embodiment. Photographic and dimensional measurements are performed 29 days after the procedure. 40 depicts an image at day 29 post procedure showing the primary treated ablation and maturation of the primary sustained ablation area with measured edges according to the Example. 41 depicts an image at day 29 post procedure showing the primary treated resection and maturation of the primary sustained ablation area with lateral dimensions measured in accordance with the Example.

The photography and dimension measurements were repeated for 90 days post-surgery and the test area skin was perfectly smooth to the touch. 42 depicts images at 90 days post-surgery showing the primary treated resection and maturation of the primary sustained resection area with lateral dimensions measured in accordance with the Examples.

The partial ablation described herein is performed within the skin or through the entire thickness of the dermis. The ability to cut skin with scalpels (eg round, square, oval, etc.) is enhanced with the addition of additional force. Additional forces include, for example, forces applied to a scalpel or scalpel pit array as detailed herein with respect to subcutaneous ablation where the force includes one or more of a rotational force, a kinetic impact force, and a vibrational force.

The scalpel device of an embodiment generally includes a scalpel assembly and a housing. The scalpel assembly includes a scalpel array comprising a plurality of scalpels and force or device components. The scalpel assembly includes one or more alignment plates configured to accurately hold and position the scalpel in accordance with the configuration of the scalpel array and to transmit a force (eg, z-axis) from an operator to the tissue to be ablated. The scalpel assembly includes, but is not limited to, a spacer configured to hold an alignment plate coaxial and spaced a distance from the scalpel array.

The shell is configured to hold the spacers and alignment plates, and includes attachment points to the housing and drive shaft. Alignment plates and/or spacers are attached or connected (eg, snapped, welded (eg, ultrasonic, laser, etc.), heat-staking, etc.) in position on the shell to provide a rigid assembly and to provide a rigid assembly and tamping of the scalpel array. Avoid furring or reuse. The shell also protects the drive mechanism or gear ring and scalpel from contamination during use and, if necessary, can be lubricated to reduce torque requirements and increase gear life.

As an example of applying a force using embodiments herein, the ability to cut skin with a circular scalpel is improved by adding a rotating torque. The downward axial force used to incise the skin is significantly reduced when applied with rotational force. This improved ability is combined with the surgeon's ability to dissect the skin with a standard scalpel, using a combination of motion across the skin (kinetic energy) while simultaneously applying compression (axial force) to the surgeon more effectively incising the skin surface. similar.

Simultaneous application of vertical motion forces to penetrate the skin significantly reduces the amount of surface compression required. For example, the technique of throwing darts for injection was previously used by health care providers to penetrate the skin. The "impactor" action imparted to the skin by the circular scalpel fit of the embodiment enhances this modality cutting capability by simultaneously using an axial compressive force and an axial kinetic force. When used in conjunction with kinetic forces, the axial compressive force used to incise the skin surface is greatly reduced.

Conventional biopsy punches are generally intended for single use applications in tissue removal achieved by pushing the punch directly into tissue along a central axis. Similarly, partial ablation of an embodiment uses a scalpel comprising a circular configuration. While the scalpels of one embodiment may be used in a standalone configuration, other embodiments include, but are not limited to, arrays of scalpels in which the scalpels are bundled together into arrays of various sizes configured to remove skin sections. The force used to pierce the skin using a partially ablated scalpit is a function of the number of scalpels in the array, so the force used to pierce the skin increases as the array size increases.

The ability to cut skin with a circular scalpel is significantly improved by reducing the force required to pierce the skin with the addition of rotational motion about a central axis and/or an impact force along the central axis. 43 is a scalpel illustrating applied rotational and/or impact forces in accordance with an embodiment. This enhanced rotational configuration has an effect similar to that of a surgeon cutting the skin with a standard scalpel using a combination of motions (kinetic energy) to cut through the skin while the surgeon applies compression (axial force) effectively across the skin surface. give. The impact force is similar to using a staple gun or rapidly moving a hypodermic needle before impacting the skin.

A consideration for the scalpel rotation configuration is the amount of torque used to drive multiple scalpels at a desired speed, as the physical size and force of the system used to drive the scalpel array increases as the torque required increases. Because. Rows or columns or segments of the array may be driven individually or sequentially during application of the array to reduce the cutting force required for the scalpel array. Approaches for rotating a scalpel include, but are not limited to, geared, helical, slotted, internally helical, pin driven and frictional (elastomeric).

Scalpit arrays configured for partial ablation using combined rotation and axial incision use one or more rotational device configurations. For example, but not limited to, a scalpel array of devices is configured to rotate using one or more of geared, external helical, internal helical, slotted, and pin driven rotating or vibrating mechanisms. Each rotation mechanism used in the various embodiments is described in detail herein.

44 shows a geared scalpel and an array including a geared scalpel in accordance with one embodiment. 45 is a bottom perspective view of an ablation apparatus including a scalpel assembly having a geared scalpel array, in accordance with one embodiment. The apparatus includes a housing (shown transparently for clarity of detail) configured to contain a geared scalpel array for application of rotational torque for scalpel rotation. 46 is a bottom perspective view of a scalpelfit assembly with a geared scalpel array (housing not shown) in one embodiment. 47 is a detailed view of a geared scalpel pit array in one embodiment.

A geared scalpel array includes a plurality of scalpels suitable for the ablation procedure in which the array is used, and a gear is coupled to or coupled to each scalpel. For example, a gear may fit over or around the scalpel, although embodiments are not limited thereto. Geared scalpels are constructed in units or arrays, so that each scalpel rotates in unison with an adjacent scalpel. For example, once fitted, geared scalpels are installed together on an alignment plate, with each scalpel rotating in engagement with four adjacent scalpels to maintain correct alignment. The geared scalpel array is driven by, but is not limited to, at least one rotating outer shaft carrying a gear at its distal end. The axis of rotation(s) is configured to provide or transmit an axial force, which compresses the scalpel of the array into the skin during incision. Optionally, an axial force may be applied to the plate supporting the scalpel.

In another embodiment, a friction drive device is used to drive or rotate the scalpels of the array. 48 shows an array comprising scalpels in a friction drive configuration in one embodiment. The friction drive configuration includes an elastomeric ring around each scalpel, similar to the gear arrangement of the geared embodiment, and upon compression the frictional force between the rings of adjacent scalpels results in rotation of the scalpel similar to a geared array.

The ablation device includes helical scalpel arrays including, but not limited to, external and internal helical scalpel arrays. 49 shows an array including a helical scalpel (external) and a helical scalpel (external) in one embodiment. 50 depicts a side perspective view of an ablation device comprising a scalpel assembly comprising a helical scalpel array (left) and a scalpelfit assembly having a helical scalpel array (right) (housing shown) in accordance with an embodiment; . 51 is a side view of an ablation device comprising a scalpel fit assembly having a helical scalpel array assembly (housing is shown transparent for clarity of detail), in one embodiment. FIG. 52 is a bottom perspective view of an ablation device including a scalpelfit assembly having a helical scalpit array assembly (housing shown transparent for clarity of detail), in one embodiment; 53 is a top perspective view of an ablation device comprising a scalpelfit assembly having a spiral scalpel array assembly (transparent housing shown for clarity of detail), in one embodiment;

The helical scalpel configuration includes a sleeve configured to fit over an end region of the scalpel, and an outer region of the sleeve includes one or more helical threads. Once each scalpel is fitted with a sleeve, the sleeved scalpel is made up of units or arrays where each scalpel rotates with the adjacent scalpel.

Optionally, a helical thread is formed as a component of each scalpel.

The helical scalpel array is configured to be driven by a pressing plate that oscillates up and down along an area of a central axis of the scalpelpit array. 54 is a press plate of a helical scalpel fit array according to an embodiment. The pressure plate includes a plurality of alignment holes corresponding to a plurality of scalpels in the array. Each alignment hole includes a notch configured to engage a helical (external) thread on the scalpel fit sleeve. When the pressure plate is driven, each scalpel in the array rotates. Figure 55 shows a spiral scalpel array with a press plate in one embodiment.

The ablation device further comprises an internal spiral scalpel array. The apparatus includes a housing configured to contain a helical scalpel array assembly for application of a rotational torque for scalpel rotation. 56 shows an array including an inner helical scalpel and an inner helical scalpel, in one embodiment. The inner helical scalpel includes a twisted square rod (eg, solid, hollow, etc.) or insert fitted into the open end portion of the scalpel. Optionally, the scalpel is configured to include a helical region. Twisted inserts are held in place by bonding (eg crimping, bonding, brazing, welding, gluing, etc.) a portion of the scalpel around the insert. Optionally, the insert is held in place with an adhesive bond. Internal spiral scalpels are constructed in units or arrays so that each scalpel rotates with an adjacent scalpel. The helical scalpel array is configured to be driven by a driving plate that moves or oscillates up and down along the helical region of each scalpel of the scalpel pit array. The drive plate includes a plurality of square alignment holes corresponding to a plurality of scalpels in the array. As the drive plate moves up and down, each scalpel in the array rotates. 57 illustrates a spiral scalpel array with a drive plate in one embodiment.

58 depicts, in one embodiment, a slotted scalpel and an array including a slotted scalpel. The slotted scalpel structure includes a sleeve configured to fit over an end region of the scalpel, the sleeve including one or more helical slots.

Optionally, each scalpel includes helical slot(s) without the use of a sleeve. Sleeve-like scalpels are constructed in units or arrays so that the top areas of the slots of each scalpel are aligned adjacent to each other. An external drive rod is aligned and mounted horizontally along the top of the slot. When the drive rod is driven downward, the result is that the scalpel array rotates. 59 illustrates a portion of an array of slotted scalpels (eg, four scalpels) with drive rods, according to one embodiment. 60 shows an exemplary slotted scalpel array (eg, 25 scalpels) with drive rods in one embodiment.

61 illustrates an oscillating pin drive assembly with a scalpel, according to one embodiment. The assembly includes a lower plate and an intermediate plate coupled to or connected to the scalpit(s) and configured to retain the scalpit(s). A top plate or drive plate is located in an area above the scalpel and the mid plate and includes a drive slot or slot. A pin is coupled or connected to an upper portion of the scalpel, and an upper region of the pin extends beyond the upper portion of the scalpel. The slot is configured to receive the pin and hold it loose. The slot is positioned relative to the pin so that rotation or vibration of the top plate causes the scalpel to rotate or vibrate through tracking of the pin in the slot.

One or more components of the scalpel device include adjustments configured to control the amount (eg, depth) of scalpel exposure during deployment of the scalpel array in the target area. For example, the adjustment of one embodiment is configured to collectively control the placement length of scalpels in the scalpel array. The adjustment of another embodiment is configured to collectively control the placement length of a portion or set of scalpels of the scalpel array. In another embodiment, the adjustment is configured to individually control the deployment length of each individual scalpel of the set of scalpels or arrays of scalpels. Scalpit Depth Control includes a number of mechanisms configured for adjustable adjustment of scalppit depth.

The depth control of an embodiment includes an adjustable collar or sleeve on each scalpel. A collar configured to move (eg, slide, etc.) along the length of the scalpel is configured to prevent penetration of the scalpel into the target tissue beyond a depth controlled by the position of the collar. The position of the collar is adjusted by the user of the scalpel device prior to use in a procedure comprising one or more of manual adjustment, automatic adjustment, electronic adjustment, pneumatic adjustment, and adjustment under software control.

The depth control of an alternative embodiment includes an adjustable plate configured to move along the length of the scalpel of the scalpel array. The plate is configured to prevent penetration of the scalpels of the array of scalpels into the target tissue beyond a depth controlled by the position of the plate. In this way, the scalpel array is deployed into the target tissue to a depth equal to the length of the scalpel that projects beyond the plate. The position of the plate is adjusted by the user of the scalpel device prior to use in a procedure comprising one or more of manual adjustment, automatic adjustment, electronic adjustment, pneumatic adjustment, and adjustment under software control.

As an example of a depth control adjustment using a plate, variable length scalpel exposure is controlled through adjustment of the scalpel guide plate of the scalpel assembly, but is not limited thereto. 62 illustrates variable scalpel exposure control using a scalpel pit guide plate, according to one embodiment. Alternate embodiments control scalp exposure from within the scalpel array hand piece and/or under one or more software, hardware and mechanical controls.

Embodiments include mechanical scalpel arrays in which axial and rotational forces are manually applied by compressive forces from a device operator. 63 shows a scalpel assembly including an array of scalpels (eg, spirals) configured to be manually driven by an operator in accordance with an embodiment.

Embodiments include, are coupled to or connected to a rotational source configured to provide optimal rotation (eg, RPM) and rotational torque for ablating the skin in combination with an axial force. Optimal rotation of the scalpel is constructed according to the best balance between increased friction loss versus increased cutting efficiency and rotation speed. Optimal rotation for each scalpel array configuration will depend on one or more array size (number of scalpels), scalpel cutting surface geometry, scalpel and alignment plate material selection, gear material and lubrication use, and skin to name a few. based on the mechanical properties of

With respect to the forces to be considered in the construction of the scalpels and scalpels arrays described herein, FIG. 64 illustrates the forces exerted on the scalpels by being applied to the skin. Parameters considered when determining the applicable force in one embodiment include:

Average Scalpit Radius: r

Scalpit rotation speed: ω

Scalpit Axial Force: Fn (scalpit applied perpendicular to the skin)

Skin friction coefficient: μ

Friction: Ff

Scalpit Torque: τ

Motor Power: Php.

In initial application, the torque used to rotate the scalpel is a function of the axial force (normally applied to the skin surface) and the coefficient of friction between the scalpel and the skin. This frictional force initially acts on the cutting surface of the scalpel. For the initial application of Scalfit to the skin:

Ff = μ*Fn

τ = Ffr

Php = τ*ω/63025

The initial force at which the scalpel pit penetrates the skin is a function of the scalpfit sharpness, the axial force, the tensile strength of the skin, and the coefficient of friction between the skin and the scalpel. After the scalpel pit penetrates the skin, the frictional force increases as there is additional frictional force acting on the scalpel's sidewalls.

An ablation device of an embodiment includes a dynamic impingement dissection device and a method for non-rotational piercing of skin. Approaches for direct compression of the scalpel pit into the skin include axial force compression, single axial force compression + power impact force, and high-speed movement of the scalpel pit to impact and penetrate the skin. 65 illustrates constant axial force compression using a scalpel, according to one embodiment. Steady axial force compression puts the scalpel in direct contact with the skin. Once in place, a continuous and constant axial force is applied to the scalpel until it penetrates the skin and progresses through the dermis to the subcutaneous fat layer.

FIG. 66 illustrates dynamic impact force using constant uniaxial force compression plus a scalpel, in one embodiment. A steady single axial force compression + dynamic impact force puts the scalpel in direct contact with the skin. An axial force is applied to maintain contact. The distal end of the scalpel collides with another object, imparting additional kinetic energy along its central axis. This force causes the scalpel to penetrate the skin and progress through the dermis to the subcutaneous fat layer.

67 illustrates impacting the skin and moving the scalpel at a penetrating rate, according to an embodiment. The scalpel is located at a short distance from the target area of the skin. Kinetic force is applied to the scalpel to achieve the desired speed to penetrate the skin. The kinetic force causes the scalpel to penetrate the skin and progress through the dermis to the subcutaneous fat layer.

The scalpel of one embodiment comprises a plurality of cutting surfaces or blade shapes suitable for cutting methods of procedures involving the scalpel. Scalpit blade shapes include, but are not limited to, for example, straight edges (eg cylindrical), beveled multi-needle tips (serrated, etc.), and sinusoidal. As an example, FIG. 68 shows a multi-needle tip in one embodiment.

Scalpits include, for example, one or more types of square scalpels. Square scalpels include, but are not limited to, square scalpels without a plurality of sharp points and square scalpels with a plurality of sharp points or threads. 69 shows an unthreaded square scalpel (left) and a square scalpel with a plurality of threads (right), according to one embodiment.

The partial ablation apparatus of one embodiment comprises the use of a square scalpel assembled on an array of scalpels having a plurality of sharp points to facilitate skin plugs via direct non-rotational dynamic impact. The square shape of the collected skin plugs gives the assembled skin plugs a one-to-one and point-to-point approximation to the adhesive film. The closer the approximation of the skin plug, the more uniform the shape of the skin graft in the implantation area. In addition, the skin plugs of each component collected have an additional surface area (eg 20-25%).

The scalpel also includes one or more types of oval or round scalpels. Round scalpels include, but are not limited to, round scalpels with beveled tips, round scalpels with multiple sharp points or threads, and round scalpels with multiple sharp points or threads. 70 illustrates a plurality of side, front (or rear) and side perspective views of a rounded scalpel having a beveled tip according to one embodiment. 71 illustrates a rounded scalpel with serrated edges according to one embodiment.

The ablation device of one embodiment is configured to include extruded pins corresponding to scalpels. 72 shows a side view of an ablation device including a scalpel assembly with a scalpel array and extruded pins (housing shown transparently for details), according to one embodiment. 73 is a top cutaway perspective view of an ablation device including a scalpel assembly with a scalpel array and extruded pins (housing shown transparently for clarity of detail), according to one embodiment. 74 shows a side and top perspective view of a scalpel assembly including an array of scalpels and extruded pins, in one embodiment;

The extruded pin of one embodiment is configured to, for example, remove a retained skin plug. Another embodiment of the extruded pin is configured to inject into the defect portion in the implantation region. Another embodiment of the extruded pin is configured to inject a skin plug into a pixel canister of a docking station for partial skin implantation.

Embodiments of the present invention include the use of a vibrating component or system to facilitate skin plugs with rotational torque/axial force and use vibrations to facilitate skin plugs into direct impingement without rotation. 75 is a side view of an ablation apparatus including a scalpel assembly having a scalpel array assembly coupled to a source of vibration, in accordance with one embodiment.

An embodiment of the present invention includes an electromechanical scalpel array generator.

76 illustrates a scalpel array driven by an electromechanical source or a scalpel array generator according to one embodiment. Although the function of the generator is powered but not electronically controlled, embodiments are not so limited. The platform of an embodiment includes control software.

Embodiments include or are coupled to a supplemental energy or force configured to reduce an axial force used to ablate skin (or other tissue surface, such as a mucous membrane) by a scalpel in a scalpel pit array. Supplementary energies and forces include, but are not limited to, one or more of rotational torque, rotational kinetic energy (RPM), vibration, ultrasonic and electromagnetic energy (eg, RF, etc.).

Embodiments herein include a scalpel array generator comprising and/or coupled to an electromagnetic radiation source. Electromagnetic radiation sources include, for example, one or more of radio frequency (RF) sources, laser sources, and ultrasonic sources. Electromagnetic radiation is provided to aid in dissection of the scalpel.

Embodiments include a scalpel mechanism comprised of a “sewing machine” scalpel or array of scalpels in which the scalpel is repeatedly retracted and deployed by one or more of manual, electromechanical, and electronic controls. The embodiment includes a moving scalpel or array of scalpels to ablate regions row by row. For example, ablation may take the form of a stamping approach in which a scalpel or array of scalpels is moved. Alternatively, the array may be rolled over the surface to be treated and Scalfit Array ablation may proceed to achieve the desired ablation density at a given distance.

The partial ablation apparatus described herein is configured for partial ablation and implantation in which the collection of partially ablated skin plugs is performed under vacuum, depositing the plugs within the lumen of each scalpel shaft. The skin plug is then inserted into the separate docking station described herein by an array of proximal pins that protrude the skin plug from within the shaft of the scalpel.

77 is a diagram of an ablation apparatus including a vacuum system in one embodiment. The vacuum system includes a vacuum tube configured to draw air from the housing to create a vacuum within the housing and a vacuum port on the device housing. The vacuum of one embodiment is configured to provide for vacuum stenting/fixing of the skin for scalpel incision to provide improved depth control and incision efficiency.

Another embodiment vacuum is configured for vacuum evacuation or collection of skin plugs and/or hair plugs through one or more scalpel lumens and array manifold housings. 78 illustrates a vacuum manifold applied to a target skin surface to evacuate/collect an ablated skin/hair plug, according to one embodiment. A vacuum manifold configured to be applied directly to the skin surface is connected or coupled to a vacuum source. 79 illustrates a vacuum manifold having an integral wire mesh applied to a target skin surface to drain/collect an ablated skin/hair plug, according to one embodiment.

An external vacuum manifold is also used in conjunction with a suction assisted fat removal machine to subcutaneously drain superficial subcutaneous fat through a partially resected skin defect in a partially created area for cellulite treatment. 80 depicts a vacuum manifold having an integral wire mesh constructed under vacuum in accordance with an embodiment.

The external vacuum manifold may be configured to contain and be arranged with an integrated docking station (described herein) for harvesting the skin plug for implantation. The docking station may be one or more of static, expandable and/or collapsible.

The partial ablation apparatus described herein includes a separate docking station configured as a platform for assembling a partially collected skin plug into a more uniform skin sheet for skin grafting. The docking station includes a perforated grid matrix comprising perforations of the same pattern and density as the scalpels on the scalpel array.

A retention canister positioned adjacent to each puncture is configured to maintain and maintain alignment of the collected skin plug. In one embodiment, the epidermal surface is upward at the perforation level. In another embodiment, the docking station can be partially collapsed to more closely approximate the docked skin plug before being captured on the adhesive film. The entrapped fragment skin graft on the adhesive membrane is shed with an embedded or non-embedded incision blade. In another embodiment, the adhesive membrane itself has elastic recoil properties that bring or position the entrapped skin plug into the closed position. Regardless of the embodiment, the contracted skin graft/adhesive membrane composite is applied directly to the graft area defect.

Embodiments include a collapsible docking station or tray configured to receive and maintain orientation of the oriented skin and/or hair plug once the retracted skin and/or hair plug is removed or ejected from the scalpel via an extruded pin. 81 shows a collapsible docking station and an inserted skin pixel in one embodiment. The docking station is formed of an elastomeric material, but without limitation. The docking station is configured to extend from the first shape to a second shape aligning the pixel receptacle with the scalpel array on the hand piece. 82 is a top view of a docking station (eg, elastomer) in stretched (left) and unstretched (right) configurations, in accordance with one embodiment;

Pixels are ejected from the scalpel array until they fill up with the docking station, which relaxes into a pre-expanded shape that has the effect of bringing the pixels closer together. A flexible semipermeable membrane with adhesive on one side is unfolded and placed on a docking station (adhesive side down). Once the pixel is attached to the membrane, it is lifted from the docking station. The film then returns to its normal unstretched state, which has the effect of pulling the pixels closer together. A membrane is then placed over the graft area defect.

The ablation device described herein includes delivery of a therapeutic agent through an ablated defect created with the ablation device. As such, the ablation zone is configured for use as a topical application injection zone for delivery or application of therapeutic agents for the reduction of fat cells (lipolysis) during or after ablation.

Embodiments of the present invention are configured for hair transplantation comprising vacuum collection of a hair plug into a scalpel at an implantation area and mass injection (without a separate collection reservoir) of the collected hair plug into a partially resected defect of the implantation area. do. In this embodiment, the donor scalpfit array disposed on the occipital scalp includes scalpels having a relatively larger diameter than the constituent scalpfits of the scalpelfit array disposed to create a defect in the implantation area. After collecting the hair plugs at the donor site, the defects created at the implantation site are closed using the collected hair plugs delivered to the scalpelfit array.

Due to the elastic contraction of the incised dermis, the elastically contracted diameter of the hair plug collected from the occipital scalp is similar to the elastically contracted diameter of the partially resected defect of the implantation area in the varicella-occipital scalp. In one embodiment, the hair plugs collected in the donor scalpit array are extruded directly in the same pattern as the partial defect created by the implantation area scalpit array with the proximal pins in the lumen of the scalpelfit. The scalpels (including the donor hair plugs) of the array of scalpels placed in the donor region are aligned in the same pattern (eg, with the naked eye) as the partially removed defect regions in the scalp region of the recipient. Upon alignment, a proximal pin in the shaft of each scalpel is advanced under the shaft of the scalpel to extrude the hair plug into a partially resected defect of the implantation area, thereby simultaneously implanting a plurality of hair plugs into the implantation area. Mass implantation of hair plugs in a partially resected graft area (eg, bald scalp) will likely maintain hair shaft alignment with other mass implanted hair plugs in the transplanted scalp area. Directed occlusion of the donor region region is performed with, but is not limited to, the most clinically effective vectors.

The partial ablation apparatus described herein is configured for tattoo removal. Later, many patients want to have their pigmented tattoo removed for a variety of reasons. In general, removal of a tattoo involves removal of the pigment embedded within the dermis. Conventional tattoo removal approaches have been described as direct surgical excision from thermal removal of pigment. Thermal removal by laser often results in discoloration or scarring of the surface. Surgical resection of a tattoo requires a linear scar that is essential for the surgical procedure. For many patients, the trade-off between tattoo removal and surgical sequelae is unimportant.

Using partial excision to remove a tattoo can partially remove a significant portion of the skin pigment while minimizing visible scarring. Partial ablation is done beyond the borders of the tattoo to blend the ablation into the non-tattoo-free skin. Most obviously, it does not reveal the pattern of the tattoo, even if all residual pigment is not removed or cannot be removed. In one embodiment, an initial partial ablation is performed with a Scalpit array, and any subsequent partial ablation is performed by a single Scalpit ablation for residual skin pigmentation. As with other applications described herein, directed occlusion is performed in the most clinically effective vectors.

The partial ablation apparatus described herein is configured for the treatment of cellulite. These aesthetic modifications have not been an effective treatment for decades because the pathological mechanisms of action have many causes. Cellulite is a combination of skin sagging and superficial fat growth and accents due to aging or weight loss. Unsightly cobblestone-shaped skin is common on the hips and lateral thighs. Effective treatment must address each cause of the malformation.

The partial ablation device described herein is configured for partial ablation of skin to tighten the affected skin and simultaneously reduce significant fat locations contributing to cobblestone surface morphology. Through a partially ablated defect created for skin tightening, a topically applied vacuum is used to percutaneously aspirate a location of superficial fat. In one embodiment, a clear manifold suction cannula is applied directly to the partially ablated skin surface. The appropriate vacuum pressure used in a suction-assisted lipectomy (SAL) device is determined by visually measuring the appropriate amount of fat under the skin to be aspirated. The appropriate duration of manifold application is also a monitored factor in the procedure. When combined with partial skin tightening, only a relatively small amount of fat is aspirated and excised to create a smoother surface morphology. As with other applications described herein, the partial ablation area is closed with a directed closure.

The partial ablation device herein is configured for correction of abdominal streaks and scars. Visually, a scar is a malformation that clearly represents a scar on adjacent normal skin. Identification of scars is made by changes in texture, pigment and contour. In order to make the scar inconspicuous, the above three components for scar correction must be addressed to greatly reduce the visual impact. Severe scarring across the joint may limit the range of motion. In most cases, scar correction is performed surgically, and the scar is excised in an oval shape and carefully closed the resected margin of the scar-free skin. However, surgical correction reintroduces the existing scar and replaces it with an existing surgical scar that is contoured or partially contoured by Z or W plastic surgery.

Scars are diagnostically bifurcated into hypertrophic and nontrophic types. Hypertrophic scars typically have raised contours and irregular tissue and are more deeply pigmented. Conversely, non-trophic scars have a recessed contour below the level of adjacent normal non-neural skin. They are also paler in color (discolored) and softer in texture than normal adjacent skin. Histologically, hypertrophic scars are enriched with non-systemic skin scar collagen with hypersensitive melanocytes. Non-trophic scars lack dermal collagen, resulting in little or no melanocyte activity.

The partial ablation device described herein is configured for partial scar correction that avoids additional surgical scar re-creation and instead does not significantly reveal visual anomalies. Partial resection of scars instead of linear surgically induced scars allows pigment, tissue and contour components to be reduced. Partial correction is performed along the linear dimensions of the scar and extends beyond the boundaries of the scar into normal skin. Partial correction of scarring is directed partial resection of the scar tissue by micro-interlacing of normal, unwounded skin with residual scarring. In essence, micro W plastic surgery is performed on the full extent of the scar. As with other applications, the partial ablation area is closed with directed closure. Examples of partial corrective uses include correcting the abdominal lumen after nutritional deficiencies. Micro-interlacing of the dermis with the indented wound and adjacent normal skin greatly reduces the anomaly indentation, linearity and pigmentation.

The partial ablation device described herein is configured for vaginal restoration for a relaxed and prolapsed postpartum period. Vaginal delivery of a preterm fetus involves, in part, a tremendous stretch of the vaginal opening and vaginal canal. During childbirth, elongation of the longitudinal side of the labia occurs with transverse expansion of the labia, vaginal opening and vaginal ulcers. In many patients, birth trauma results in permanent stretching of the vaginal canal both longitudinally and transversely. Vaginal restoration for prolapse is typically performed by an anterior-posterior resection of the vaginal mucosa with a prosthetic mesh inserted. In patients with severe prolapse, this procedure is necessary because additional support of the anterior and posterior vaginal walls is required. However, many patients who experience vaginal relaxation after delivery may be candidates for less invasive treatments.

The partial ablation device described herein is configured to partially ablate the vaginal mucosa to narrow the dilated vaginal canal at the labia and entrance. The pattern for partial resection can also be performed longitudinally when the vaginal canal is elongated. Directed occlusion of the partial region can be aided by a vacuum tampon acting as a stent to shape the partially resected vaginal canal into its pre-partum configuration.

The partial ablation device described herein is configured for the treatment of snoring and sleep apnea. While snoring has little to no health impact, the annoying noise it makes to your sleeping partner can be serious. In most cases, snoring is due to dysphonic vibrations of the oral and pharyngeal soft tissue structures in the oral cavity, pharynx, and nasal passages during breathing. More specifically, the soft palate, nasal turbinate, lateral pharyngeal wall, and vibration of the tongue are key anatomical structures that induce snoring. Many surgical procedures and medical devices have had limited success in improving the condition. Surgical resection of the soft palate is often accompanied by a long recovery period and pain due to bacterial contamination of the incision area.

The partial ablation device described herein is configured for partial ablation of the oropharyngeal mucosa to reduce age-related mucosal overlap (and relaxation) of oral and pharyngeal soft tissue structures, and is pain-free due to long-term bacterial contamination of the fragment resection area. Reducing the size and looseness of these structures reduces vibrations due to the passage of air. An intraoral dental retainer (fixed to the teeth and wrapped around the posterior part of the soft palate) perforated (to dispense local anesthetic over the partial resection field) is used to provide an anterior-posterior directional closure of the soft palate. A more serious condition called sleep apnea has serious health implications due to hypoxia caused by upper airway obstruction during sleep.

Although CPAP has become the standard of care for sleep apnea treatment, selective partial resection of the base of the tongue and lateral pharyngeal wall can significantly reduce sleep-related upper airway obstruction.

The fractional ablation device described herein is configured for fractional skin culture/extension and is referred to herein as a "culture span". The ability to grow skin organically is a major achievement for patients with large skin defects such as burns and trauma and for major congenital skin anomalies such as port wine stains and large 'basing trunks'. Although conventionally limited to providing long-term viability of the collected skin, some reports have shown that wound healing has occurred in skin cultured specimens of organ types. It has been reported that improved culture results will occur with better substrates, more effective filtration of cultured broths and metabolic by-products. The use of gene expression proteins for stimulating growth hormone and wound healing is also promising. However, to date, there have been no reports that the skin is growing organically.

According to an embodiment, partial harvesting of autologous donor skin for skin transplantation provides an opportunity for culturing organoids of skin that did not previously exist. As provided by the embodiments described herein, the deposition of the partially collected skin graft on the collapsible docking station causes the skin plugs to be placed in contact with each other. Induction of the primary wound healing process can convert partial skin grafts into solid sheets by known or soon-to-be developed organotypic culture methodologies. In addition, the use of mechanical skin swelling can also greatly increase the surface area of organically preserved/grown skin. The in vitro matrix device iteration method comprises a partially collected skin plug and a separate matrix (e.g., curved, flat, etc.) inflator that is controllable to provide a gradual and continuous expansion of full thickness organically cultured skin. including, without limitation, an inflatable docking station. In addition, the use of organoid skin extensions can provide sustained and synergistic wound healing stimulation for organoid growth. A gradual and continuous expansion is less likely to separate the epidermis of the dermis from the basement membrane (lamellar membrane). In addition, organoid skin extension helps avoid the surgical risks and pain associated with skin extension in vivo.

The partial ablation device described herein enables a method for organ-type expansion of the skin. The method comprises autologous sampling of skin from a donor site of a patient. For example, the use of a rectangular scalpel-fit array provides side-to-side and tip-to-tip connections of partially collected skin plugs. The method includes transferring the partial skin plug to a collapsible docking station that maintains orientation and provides juxtaposition of the skin plug. The docked skin plug is entrapped in a porous adhesive membrane that maintains orientation and parallelism. The anti-elastic rebound properties of the adhesion membrane provide additional contact and parallelism of the skin plug. The method transfers the adherent membrane/partial graft complex into a culture medium comprising a substrate and a culture medium and includes a medium that maintains viability and promotes wound healing and growth of the organ. After the skin margin has healed, the entire substrate is placed in a culture bath with a mechanically expanded substrate. Organ type expansion begins in a gradual and continuous manner. The expanded full-thickness skin is autologous to the patient's treatment area defect.

Organ-type skin enlargement may be performed on non-partial skin grafts or, more generally, on other tissue structures such as organ-type extensions. The use of mechanical stimuli to elicit wound healing responses to organ-type cultures can also be an effective intervention.

The embodiments described herein are used as components and/or as components of one or more devices and methods detailed in this specification and related applications incorporated herein by reference. In addition, embodiments described herein may be used in devices and methods related to partial ablation of skin and fat.

Embodiments include novel minimally invasive surgical methods that have a wide range of advantages over conventional cosmetic surgery procedures. Partial resection of the skin is applied as a novel stand-alone procedure in an anatomical area that goes beyond the limits of conventional plastic surgery due to an insufficient compromise between the visibility of incision scars and the amount obtained. Partial resection of the skin is also applied as an adjunct to conventional cosmetic surgery procedures such as liposuction and is used to significantly reduce the length of the incision required for certain applications. The shortening of the incision is applied in both the aesthetic and reconstructive realms of plastic surgery. Without limitation, both the procedure and device development of partial resection are described in detail herein.

Embodiments described herein are configured to remove a plurality of small portions of skin without scarring instead of conventional linear ablation of the skin. Removal of several small portions of the skin involves removing the flaccid excess skin without apparent scarring. For example, FIG. 83 depicts the removal of flaccid excess skin without apparent scarring in one embodiment. Removal of the plurality of small sections 8302 of the skin includes tightening the skin without an apparent threat, eg, FIG. 84 illustrates tightening the skin without an apparent threat according to one embodiment. Removal of the plurality of small sections 8402 of the skin further includes partial skin tightening where the clinical endpoint results in a three-dimensional contouring of the skin integument.

85 depicts a three-dimensional contour of a skin sheath in one embodiment.

The clinical effectiveness of any surgical procedure requires an understanding of the underlying processes leading to the clinical endpoint. Several mechanisms of action are described here for partial skin tightening and contouring. The identified principle mechanism of action is the transformation of a two-dimensional partial skin into a three-dimensional aesthetic contour (see Fig. 3). The clinical endpoint for that principle is a secondary mechanism that acts in concert with each other. Contributing mechanisms are described herein according to, but not limited to, ability to achieve clinical endpoints.

The density of partial ablation within the contoured subregion is a major determinant of 2D skin tightening that contributes to 3D contour formation. Density is generally, but is not limited to, the percentage of partially ablated skin within a partial area. 86 illustrates variable partial ablation density 8602 in treatment area 8604 in one embodiment. The density of partial ablation can be varied to tighten and contour more skin with a smoother transition to non-partially ablated areas. Thus, for example, transition to a non-partially ablated region includes, but is not limited to, a decrease in fractional density.

A further embodiment includes partial ablation of fat associated with partial skin ablation. 87 illustrates partial resection of fat in one embodiment. Directly under the skin are layers of skin and subcutaneous fat, in which fats of various sizes (based on depth and/or amount) can be excised in anatomical continuity with ablated skin plugs. The amount of partially excised variable amount of fat and thus skin tightening and contouring is controlled by controlling one or more depths. Thus, the density of partial ablation (“partial density”) to provide a more carefully selected skin tightening and contouring while allowing for a smoother transition to non-partially ablated parts is determined by determining one or more of partial density, ablation depth and ablated fact. can be controlled and changed. Thus, for example, transition to a non-partially ablated area includes, but is not limited to, a decrease in fractional density, ablation depth, and amount of ablated fact.

An additional modality for partial fat resection is percutaneous vacuum resection (PVR) of fat through partial skin defects. Numerous clinical applications for partial fat resection are envisaged in the examples herein. The most important aesthetic application of partial liposuction is the reduction of cellulite. The successive application of partial skin and fat excision directly addresses the underlying pathology of this aesthetic transformation. Significant areas of fat and sloughing of the skin leading to the formation of pebbles of the skin morphology and visible surface are resolved with the application of minimally invasive ablation capabilities. 88 depicts cobblestoned 8802 of the skin surface.

In addition, another common application includes partial liposuction and the ability to alter three-dimensional contour abnormalities using a combined continuous approach of drawing internal contours in partial liposuction. Preoperative topographic contour mapping of subregions helps to provide more predictable clinical outcomes. In essence, topographic mapping of two-dimensional partial skin ablation is combined with various markings for fat ablation. 89 depicts a topographic mapping (dotted line) 8902 for deeper levels of branch fat ablation according to an embodiment. The mapping also includes feathering or transitional regions as non-ablation regions with reduced partial density. Depending on the patient's preoperative topographical indications, a variable amount of fat is subsequently excised with partial skin resection.

Corrective areas containing convex contours will undergo a smaller bifurcation. Concave (or depressed) areas are corrected using partial skin excision. The end result within the mapped subregion is the overall smoothing of the three-dimensional contour with a two-dimensional tightening of the skin.

Combining partial excision is most obviously reducing the length required for conventional plastic surgical incisions and eliminating the surgeon's incision skin grafts ("Dog Ears"). Standard resection of skin lesions does not require additional scarring of the elliptical incision, but greatly reduces the linear dimension required for closure of the incised lesion (see FIG. 94).

An additional mechanism of action associated with partial skin resection is the overall contour pattern size of the partial resection area. The total amount of partially ablated skin depends on the size of the partially ablated area. The larger the area, the tighter the skin is with a certain density of partial ablation.

90 depicts a plurality of treatment schemes according to an embodiment.

The mechanism of action of the pattern contour involves the selective curvilinear patterning of each specific anatomical region for each specific patient. The digital wire mesh program performs topographical analysis using the digitally captured image of the patient associated with the rendered (and re-rendered with enhanced contour) digital wire mesh program to specify the selected anatomical area and the size and curved contours of the patient. . Patterns of standard cosmetic plastic surgery resections for specific anatomical areas also aid in the formatting of partial resection patterns. 91 illustrates a curve treatment pattern 9102 in one embodiment. 92 shows a digital image of a patient with a rendered digital wire mesh 9202 program, in one embodiment.

The directed closure of the partial ablation area of an embodiment provides the ability to selectively tighten the skin to achieve aesthetic contour enhancement. In most applications closure occurs at the Langer line, but can also be performed in other orientations to achieve maximum aesthetic contours, such as closures based on dormant tension lines. 93 shows directed closure 9302 of a partially ablated area in one embodiment. Directed closure may also follow the known vectors of closure used in conventional cosmetic surgical procedures (e.g., facial paralysis for the face/partial region component of facial paralysis upwards (corresponding to horizontal closure of partial nodes). ), and the neck component below the cervical mandibular angle is more obliquely posterior (corresponding to a more vertically defined closure of the partial region). Multiple vectors of directed closure can also be used in more complex topographical areas, such as the face and neck.

An embodiment includes directional partial ablation of the skin, which improves the effectiveness of the procedure. The articulation is performed by pre-stretching the skin perpendicular to the desired direction of maximal skin ablation. 94 shows directional partial ablation of skin according to one embodiment.

Embodiments include aesthetic contours due to mechanical traction (or vectors) generated from adjacent subregions adjacent to the desired contour. This effect on subregions is based on plastic surgery at a certain distance from the target outline. In addition, a variable topographical transformation of ablation density in situ and along the pattern outline is realized, providing selective contouring and smooth transition to non-contoured regions.

Additionally, variably topographical transformation of scalp-size ablation within the patterned contour (and to different scalp-fitting sizes within the array) provides selective two-dimensional skin tightening and three-dimensional contouring.

The embodiments described herein result in a selective wound healing process with accelerated primary treatment during the immediate post-operative period and delayed secondary contraction of the skin during the collagen proliferation phase. Acceleration of the correct bonding of the skin margins is inherent in multiple (partial) ablation of small skin sections. That is, the skin margins are more closely aligned than the larger linear excisions commonly seen in standard plastic surgery incisions. Subsequent evoking wound contraction is also inherent in the partially resected region where stretching of the pattern of partial resection provides a directional wound healing response along the longitudinal dimension of the partially resected pattern.

The clinical method of partial skin resection includes the directional occlusion method. Depending on the anatomical area, directed closure of the resected skin defect within the partial resection area is oriented towards achieving Langer's line, resting skin line and/or maximal aesthetic contouring. The direction in which the closure is most easily achieved can also be used as a guide for the most effective orienting closure vector. Many applications use the Langer line to provide maximum aesthetics. Following Dr. Langer's original work, the partially resected defect extends in the direction of the Langer line. Directed closure is performed at right angles to the Rae Langer line in the anatomical domain. The skin margin of each partial resection defect is the closest approximation.

In a continuous partial resection placed adjacent or consecutive to a plastic surgery incision, the most important function provided by this embodiment includes the ability to shorten the incision. The need for oval resection of skin tumors is reduced both with the application of this technique and with the length of the incision. Therefore, the need to resection the lateral extension of the tumor resection is eliminated with partial resection in the same aspect. 95 illustrates shortening of an incision through a continuous partial procedure in accordance with an embodiment.

As the partial region according to the embodiment heals without visible scarring, the end result is a significant reduction in the length of the incision scar. Another application in this category is the shortening of conventional plastic surgery incisions used in mammoplasty, mammoplasty and abdominoplasty. The lateral extent of such an incision can be shortened without creating "poison ear" skin relaxation that occurs with an equal length incision. 96 is an exemplary depiction of “poison ear” skin relaxation in breast reduction and abdominoplasty. For example, it is no longer necessary to extend the incision beyond the barrier for breast reduction or abdominoplasty. Partial correction of postoperative "poison ear" skin relaxation can be performed without extending the existing incision.

Embodiments include a combined procedure that provides aesthetic enhancement in both the partial ablation collection area and the donor site. The most obvious application of the method is partial harvesting of cervical beards for hair transplantation from the scalp in the frontal and parietal regions. The double advantage is the process of creating an aesthetic contour on the front neck and restoring the hair with the scalp.

Examples include separate partial procedures in anatomical areas not currently covered by plastic surgery due to insufficient trade-offs between the visibility of surgical incisions and the amount of aesthetic enhancement. A few examples exist in this category, such as bra skin relaxation on the humerus knee, forearm, elbow, back, and medial and lateral thigh and inner folds.

Embodiments include an adjunct partial procedure that evolves into a conventional plastic surgical incision in a non-continuous manner. This category includes suction-assisted liposuction, which involves the suction and removal of subcutaneous fat from areas of lipodystrophy, such as the lateral waist and thighs. However, many patients have pre-existing skin laxity that is exacerbated by suction liposuction. Tightening the skin integument in this area with partial excision has several advantages for these patients. Many patients with skin laxity and lipodystrophy are candidates for liposuction. For patients with no pre-existing skin laxity but with more significant lipodystrophy, greater contour reduction can be achieved without mimic skin laxity. This procedure can be performed either as a small partial resection or as a single combined procedure for a step-by-step procedure.

Directed closure of the partial region is performed without sutures and is achieved by applying an adhesive stent membrane as detailed herein. The partial region is closed with an adhesive film using a plurality of methods. An exemplary method includes securing the membrane outside the perimeter of the partial region. A tensile force is then applied to the opposite ends of the adhesive film. A body of adhesive film is applied to the sub-region row by row with respect to the remaining skin in the region. The application direction follows the selected closing direction vector. This application direction is sometimes similar to, but not limited to, Langer lines, any application direction that provides maximum aesthetic contour can be selected.

Another method involves the use of the elastic properties of an adhesive stent dressing to selectively close the partial region. Using this method, the tip of the elastic stent dressing is stretched or preloaded and the stent dressing is applied to a partial area. When the end of the membrane is released, the elastic recoil of the stent dressing closes the partial defect in a direction perpendicular to the elastic recoil.

Embodiments detailed herein include a skin pixel array skin referred to as sPAD. The sPAD comprises an associative multiple scalpel array comprising a plurality of individual circular scalpels. As described herein, the scalpel assembly and the scalpel are connected or linked to an electromechanical power source through a series of gears or other drive components between each scalpel and the drive shaft. In addition, a vacuum is generated within the housing and configured for stent stabilization during incision. The same vacuum capability may be applied as a pneumatic assist device that applies an additional axial (Z-axis) force during the cutting duty cycle. Another vacuum application is the puncture of an incised skin plug in the field of partial incision.

The sPAD comprises a plurality of components as detailed herein.

97 is an sPAD comprising a single skive scalpel with depth control, according to one embodiment. 98 is an sPAD comprising a standard single scalpel in accordance with one embodiment. 99 is an sPAD including a pencil style gear reduction carrier according to one embodiment. 100 is an sPAD comprising a 3x3 centerless array according to one embodiment.

Equipment comprising a surgical drill is provided for use with the sPAD. 101 is an sPAD comprising a cordless surgical drill carrier in one embodiment. 102 is an sPAD comprising a drill-mounted 5x5 centerless array in accordance with one embodiment.

An embodiment includes a vacuum assisted pneumatic ablation (VAPR) array sPAD, referred to herein as a VAPR sPAD. 103 is an sPAD comprising a vacuum assisted pneumatic ablation device according to one embodiment. The VAPR sPAD includes a vacuum pressure configured to induce the scalpel in the sPAD into the treatment area. The VAPR sPAD is coupled or coupled to the drill via drill array coupling (DAC). 104 is a VAPR sPAD coupled to a drill via a DAC, according to one embodiment. The DAC secures the housing of the VAPR sPAD to the drill, while the hex tube allows the VAPR sPAD drive shaft to move up and down during processing. A vacuum (not shown) provided externally to the VAPR sPAD is connected or coupled through the vacuum port.

105 depicts VAPR sPAD in the ready state (left) and extended treatment state (right), in one embodiment. With vacuum and drill actuation, a single treatment cycle involves placing the VAPR sPAD against the treatment area to create a seal portion between the housing and treatment area. Once the seal is formed, the vacuum pulls the piston together with the rotating gear into the treatment area. After the desired depth of cut is achieved, the sPAD is removed from the treatment area. This breaks the seal and the spring inside the sPAD puts the seal back in ready state. This cycle can now be repeated in other treatment areas.

Embodiments include a spring assisted vacuum ablation (SAVR) sPAD that operates in a manner similar to a VAPR sPAD. 106 shows SAVR sPADs in a ready state (left) and a contracted state (right) according to an embodiment. The SAVR sPAD is connected or coupled to the drill via a DAC. The vacuum port is attached to a separate vacuum supply. The drive shaft slides back and forth within a tube attached to the drill.

The spring and vacuum positions in the SAVR sPAD are generally opposite to the spring and vacuum positions in the VAPR sPAD. The spring and vacuum ports are both located on the proximal side of the piston, but without limitation. The vacuum helps draw the skin pixels through the scalpel and thus away from the treatment area. The spring provides an axial force for the rotating scalpel to enter the treatment area and ablate the skin. The scalpel extends out of the housing in array readiness.

A treatment cycle begins with placing the scalpel in the desired treatment location. The vacuum is turned on and the drill is applied downward, which retracts the piston and scalpel into the housing (retracted). The drill rotates and the scalpel rotates. The spring force coupled with the scalpel rotation performs the ablation. The vacuum draws the pixels created by the ablation into the housing and then out of the housing. Once the desired depth of cut is achieved, the SAVR sPAD is lifted off the treatment area and the cycle can be repeated.

Embodiments include, but are not limited to, instruments and procedures for aesthetic surgical skin tightening, including equipment or devices, and procedures that allow for repeated harvesting of skin implants from the same donor while eliminating donor site modifications. . Embodiments herein include apparatus configured for fragment ablation and countermeasures methods or procedures, including single-scalpit and multi-scalpit array platforms using vacuum manifolds. Further disclosures of corresponding devices configured for partial ablation and corresponding methods or procedures are found in related applications, each of which is incorporated herein by reference in its entirety. With respect to using a vacuum in the partial ablation region, the vacuum manifold is configured to apply a vacuum within a blood vessel within a scalpel (or within a multiple scalpel array). Optionally, the vacuum manifold is configured to apply a vacuum out of the oral cavity as a component of the scalpel assembly or as a separate manifold device applied directly to the skin of the partial region.

Application of the vacuum capacity of the scalpel assembly includes suction and discharge of a partially ablated skin plug (eg, FIGS. 108 , 112 and 113 ). Application of the vacuum capacity of the scalpel assembly also includes vacuum stabilization of the skin surface during partial ablation (eg, FIGS. 109 and 114 ). Additional applications of the vacuum capacity of the scalpel assembly include fractional vacuum assisted liposuction of the subcutaneous and subcutaneous fat layers (eg, FIG. 114 ).

107A is a cross-sectional side view of a vacuum aspirator configured to be coupled or attached in series with a vacuum manifold and scalpel array in accordance with one embodiment. 107B is an isometric side cross-sectional view of a vacuum aspirator configured to be coupled or attached in series with a vacuum manifold and scalpel array, according to one embodiment. 107C is a solid side view of a vacuum aspirator configured to be coupled or attached in series with a vacuum manifold and scalpel array, according to one embodiment.

108A is a cross-sectional side view of a scalpel pit array for use with a vacuum aspirator in accordance with one embodiment. 108B is an isometric side cross-sectional view of a scalpel pit array for use with a vacuum aspirator. 108C is a solid side view of a scalpel pit array for use with a vacuum aspirator in accordance with one embodiment.

109A is a cross-sectional side view of a vacuum manifold configured to be coupled or coupled to a vacuum aspirator in accordance with one embodiment. 109B is an isometric side cross-sectional view of a vacuum manifold configured to be coupled or attached to a vacuum adsorber in accordance with one embodiment. 109C is a solid side view of a vacuum manifold configured to be coupled or attached to a vacuum aspirator in accordance with an embodiment. The vacuum aspirator is connected or connected in series with the vacuum manifold, and consists of a specific adaptive aspirator for partial resection and a device such as a conventional surgical aspirator or aspirator specifically used for suction-assisted lipoectomy (SAL). In one embodiment, the intraluminal vacuum scalpel or scalpel array has a rotating component that enhances both, but not limited to, skin plug and liposuction curettage capabilities.

The vacuum delivery of the device of one embodiment is controlled with an aperture component configured for manipulation by a device operator. 110 is a solid side view of an apparatus having a vacuum component configured for manual control through an opening, according to one embodiment. Optionally, the vacuum component is electronically controlled. For example, cycling on/off of the vacuum source is at least partially computer controlled (eg, computer controlled duty cycle, etc.). An electronic controller may also be used to cycle through changes in the rotation (RPM) component of the scalpel assembly. Scalpit length may be controlled by one or more of manual and computer.

The vacuum manifold of one embodiment includes receiving a “slip on” overlay at the distal end region of the hand piece (eg, FIG. 109 ). The vacuum manifold also extends distally over the scalpel to serve as a depth guide. A variety of depth guide dependent vacuum manifolds control the dermal depth for different clinical applications and various anatomical areas. In one embodiment, the plastic manifold is created as a single disposable procedure with a separate vacuum port integrated into the manifold. In an alternative embodiment, the vacuum capability is converted via a separate side aperture of the scalpel or an "in-line" or "in-series" configuration of the hand piece where the vacuum is applied internally. 111A is an isometric view of a hand piece configured to contain or incorporate a vacuum in one embodiment. 111B is an isometric cutaway view of a hand piece configured to contain or incorporate a vacuum in one embodiment.

112 is a cross-sectional side view of a single scalpel device applied to a target tissue region, according to one embodiment. 113 is an isometric cross-sectional view of a single scalpel device applied to a target tissue region, in one embodiment. 114A is a cross-sectional side view of a multiple scalpel device applied to a target tissue region, in one embodiment. 114B is an isometric cross-sectional view of a multi-scalpit device applied to a target tissue region, in one embodiment. Scalpit devices of various embodiments include one or more scalpels. The type of scalpel in one embodiment includes one or more of a slotted scalpel and a slotted blunt micro tip cannula. 115 is an exemplary slotted scalpel in accordance with an embodiment. 116 is an exemplary slotted blunt micro tip cannula in accordance with an embodiment.

The subcutaneous fat and the ability to partially aspirate subcutaneous fat in the embodiments of the present specification have various applications depending on the target anatomical area. These applications include, without limitation, flattening of convex three-dimensional contours and inner contours of anatomical regions to restore aesthetic properties such as submandibular and cervical mandibular angles. For this application, a side slotted apertured scalpel and a blunt tip side slotted apertured partial cannula are described herein (eg, FIGS. 114 and 115 ). The blunt tip cannula is configured for use in an anatomical area where the major vascular or nerve structures are directly below the partial fat ablation area. Regardless of the scalpel/cannula type, the combination of the system's rotational function and vacuum capability provides a means to more effectively aspirate the curette of the transdermal/subcutaneous fat layer.

Embodiments include, but are not limited to, partial marking systems configured as guides to ensure adequate partial ablation density.

Guides include, for example, Adherent Semi-TransparentPolforated Plastic Membrane Guides (ASPMPs) configured for use as guides for stencils and/or partial resections. A stencil marking system includes a stencil (eg, ink, etc.) comprising a circular or dotted grid pattern that is temporarily applied prior to surgery to a target location. 117 is an exemplary ink stencil marking system in accordance with one embodiment. The circles or dots include at least one of a positive and negative stencil of a grid pattern, and the ink material is configured to be biocompatible and not smear or degrade during patient preparation or during the performance of a procedure.

The ASPPMP marking system includes an adhesive translucent penetrating plastic film. 118 illustrates an adhesive translucent perforated plastic membrane according to one embodiment. The perforated plastic membrane is also configured to serve as a depth guide to ensure that a predetermined depth of partial ablation is not exceeded. 119A shows a side view of an ASPPMP used as a depth guide for a single scalpel device according to an embodiment. 119B is an isometric plan view of an ASPPMP in use as a depth guide with a single scalpel device in accordance with an embodiment;

Clinical applications of single-scalpit and multi-scalpit array platforms include, but are not limited to, aesthetic contouring, which is most effectively created by a combination of skin tightening and inner contouring in one embodiment. The ability to partially excise skin and fat during the procedure is a significant feature compared to previous electromagnetic devices and cosmetic surgery. This is because partial resection involves the direct removal of the skin (the area of skin relaxation) without any visible scarring. The enhanced ability of the embodiment to partially ablate the skin is combined with oral subcutaneous/subcutaneous liposuction to restore a more youthful and esthetic contour. 120 depicts partial ablation of skin and partial transdermal/subcutaneous fat ablation in one embodiment. An example of unrestricted partial excision of the skin and partial percutaneous/subcutaneous fat excision is the treatment of the submandibular (under the chin). 121 is a side view of the submandibular region as a target area for partial transdermal/subcutaneous fat ablation and partial ablation of the skin, in one embodiment. 122 is a bottom (upward view) view of a partial ablation area submandibular as a target area for partial ablation of skin and partial transdermal/subcutaneous fat ablation, in one embodiment. Skin whitening and protrusion of the parathyroid fat pad are major components of this aesthetic transformation. Each patient will have a variable amount of each soft-tissue component requiring selective correction, configured for each patient or customized. More specifically, the convex appearance of the submandibular region is mainly caused by lipodystrophy of the chin fat pad and the loss of cervical mandibular angle is mainly caused by the looseness of the skin.

As patients typically exhibit varying amounts of skin edema and lipodystrophy, the examples use the patient's planning and markings for specific procedures. The combined capabilities of the assembly of embodiments correlate well with the need to modify certain aesthetically modified soft tissue components.

For patients with more severe skin laxity, a larger horizontally aligned treatment area in the submandibular and lateral neck is marked for partial skin excision. 123 illustrates horizontally aligned treatment areas of the submandibular and lateral neck for severe skin relaxation, in one embodiment.

If the patient develops more severe lipodystrophy, partial lipodissection (via partially excised skin scars) within the treatment area is indicated. The depth of partial fat ablation may optionally be altered to address the topographical features of the convex contour deformation. 124 shows a wider partial fat ablation under the chin for severe lipodystrophy, according to one embodiment.

Clinical applications of the single scalpel and multiple scalpel array platforms include direct closure specifications. A key principle used in plastic surgery procedures to promote primary healing (primary healing) that reduces scarring is the correct closing of the incision. However, the direction of the finish is also important in aesthetic contouring. Appropriate vectors of skin tightening take into account the anatomical structure to improve aesthetics. For more complex aesthetic contours such as the face and neck, several marker tightening vectors are used during the procedure.

125 illustrates an exemplary face vector and neck vector directed closure, in accordance with one embodiment. In addition to skin tightening vectors, various types of occlusion limit the tension at closure. The closed line includes that described by Karl Langer, and FIG. 126 shows Langer's closed line. Closure of the skin plug indicated by the Langer line promotes primary healing as it reduces the tension of the occlusion. When the vector of skin tightening and the Langer line match, the resulting aesthetic contouring and primary healing work in concert to provide optimal clinical outcomes.

Embodiments herein include step-by-step procedural algorithms configured to provide a more uniform reduction in procedures that produce predictable clinical outcomes. Many procedural steps (and series of steps) are unique developments of a partial resection procedure. Without limitation, a procedural algorithm is included for submandibular partial resection.

According to one embodiment of the treatment procedure, the patient is initially displayed in a sitting position prior to surgery. For patients with relatively more skin relaxation, the marked area for partial resection is large, extending to the lateral neck. For patients with relatively little or no skin relaxation, the marked partial resection area is limited to the area where the lipodystrophy of the submandibular fat pad causes convex contour deformation. For patients with skin laxity and lipodystrophy, both areas are individually represented as components of a single combined treatment outline. 127 illustrates target areas marked for partial ablation of neck and submandibular liposuction in accordance with an embodiment.

To avoid a decrease in subregional density, a block of local anesthesia is administered to the submandibular/neck border region. A dashed/circle stencil is then applied to ensure adequacy of partial ablation density, as detailed herein. 128 shows an example of displaying a stencil in one embodiment. These procedural steps can be reversed if the stencil is performed prior to injection of the local anesthetic. The swelling of the stenciled skin can be compensated for by a larger marked treatment area. Partial skin ablation is performed within the boundaries of the entire border area.

Partial fat ablation is limited to areas of marked lipodystrophy (eg, FIG. 127) and is performed in partial skin ablation or subsequent procedural steps. Clarify the boundaries of partial resection by performing transitions or freehand feathering beyond the demarcated contours.

Direct closure of partial scars is performed with an absorbent adhesive elastic bandage stretched (preloaded) with a vector of desired closure/skin tightening.

A bandage (eg Flexzan, etc.) can be preloaded by first applying one end of the bandage at the side mooring point above the partial area. Once fixed, a load is applied to the opposite end of the bandage. The load is maintained during application. The selective loading technique is to first apply opposing loads on each lateral extension of the elastic bandage. That is, the bandage is first stretched along the longitudinal axis of the material before being applied. When the load is maintained, the elastic bandage is fully applied to the partial area. Release of the load generates an elastic recoil that closes the scar in the partial region along the specified vector. In the submandibular region where there is skin relaxation of the anterior neck, a bidirectional closure with two vectors is implemented, but the embodiment is not limited thereto.

129 shows the indicated closure vectors of the submandibular and anterior neck in one embodiment. The vector for the anterior neck (submandibular) is more transverse and is used to emphasize the cervical-mandibular angle. In the submandibular case (as indicated by the Langer line) the closure vector is perpendicular. Finish the procedure by applying a sterile dressing. Compression garments are also applied to provide compression and vector support in the postoperative stage.

Examples include partial scar correction. Reduction of the visual impact caused by conventional scar deformation has been a major focus of plastic surgery since the beginning of this surgical specialty. Different surgical techniques are used depending on the type of scar deformation. A commonly used technique is oval excision of scars with overlapping occlusions. Other techniques such as Z-plasty and W-plasty are attempted to reduce the linearity of the scar. 130 depicts Z-plasty and W-plasty scar correction. However, these prior techniques allow for sagging scar deformation. Partial scar correction is constructed so that the scar does not stretch and the visible effect of the scar is reduced.

For linear scar deformation, embodiments include a technique of partial wound area delineation in which interdigitating partial excision is performed along each margin of the scar. To maximize wound area removal, directed closure of the partial area is performed perpendicular to the linear scar. 131 shows an example of a partial wound area removal technique of scar ablation according to one embodiment.

Additional de-delineation is performed with freehand partial resection beyond the scar margin. Examples include partial resection techniques for extensive hypotrophic scarring resulting from depilatory biopsy resection of skin lesions. Partial scar removal is performed within the margin of the scar to reduce the width of scar deformation. Directed closure is performed as detailed herein. 132 shows an example of partial scar resection for a wide hypotrophic scar in one embodiment. Another alternative embodiment combines, but is not limited to, partial scar correction techniques in which the combined alteration is performed in a single procedure or a sequence of scheduled procedures.

A further embodiment includes the application of partial resection to shorten the incision required to excise the lesion. This new feature can also be applied to shorten the longer plastic surgery incisions used to excise excess skin. An oval extension of the incision (to prevent "poison ear" skin overlap) is no longer necessary when the side of each incision is partially resected using the devices and methods described herein.

Partial procedures may be performed concurrently or as planned follow-up changes to the primary resection procedure. The partial ablation of the embodiment may also be used for an existing dog-ear overlap after ablation. An example is breast reduction and shortening of an intramammary incision required for breast repositioning. 133 illustrates an example including shortening of an internal breast incision as applied to breast reduction and/or breast repositioning, according to one embodiment. The incision no longer extends beyond the inner mammary nodule, making it less conspicuous.

Embodiments described herein include partial skin grafts. This includes full-thickness skin defects that have been the primary focus of plastic surgeons. Large scars that cannot be closed with direct occlusion require a more complex approach. Two existing approaches developed with plastic surgery are flap closure and skin grafting. 134 shows an example of flap closure. Local or remote flap occlusion requires an intrinsic or acupoint supply harvested with the flap at the donor site. Flap closure of skin scars is complicated by additional scar formation at the donor site.

Skin grafting (separate thickness or full thickness) is another method used to close large full thickness skin scars. Using the skin graft approach requires a donor for skin grafts and is associated with severe scarring and morbidity.

After several decades of use of these two plastic surgical approaches, a new third approach is described in the Examples herein. Partial skin grafting avoids the side effects associated with lamellar skin grafting. This is because fractional skin grafts have a unique ability to avoid the donor site deformities associated with thin skin grafts. Partial skin grafts also provide the added capability of harvesting skin grafts from the same donor. 135 depicts an example comprising a partial skin graft harvest to be applied to a donor site according to an embodiment.

Partial skin transplantation is particularly important for patients with large superficial burns, where the availability of donor sites is severely limited. The ability to harvest continuously at the same donor site is also important for patients with skin defects in the lower extremities due to impaired blood circulation. Patients such as those with venous congestion, ischemic diabetic ulcers are particularly at risk of loss of limbs if they do not immediately gain skin coverage of vascular damaged ulcers. Most of these patients must undergo a series of skin grafts before gaining skin coverage. The morbidity associated with these long-term skin transplantation procedures involving multiple organ donation areas can be particularly problematic for patients with other serious systemic conditions. In the partial skin grafts described herein, the absence of a single visible donor anomaly combined with the ability to continuously harvest skin grafts from the same donor provides the only viable treatment option for these patients. When compared to a donor site of discrete thickness skin grafts, direct occlusion of the partial donor site provides a faster healing with significantly reduced donor morbidity and scarring.

Because the partial skin graft of one embodiment is full thickness, the durability of skin coverage is improved compared to a divided thickness skin graft. Application of partial skin grafts for wound healing in these damaged receptacles can be performed without forming partial skin segments (pixels) on a more uniform sheet. In this clinical setting, "lateral angiogenesis" occurs between individual partial skin segments and the receiving bed. 136 illustrates an example including angiogenesis of the partial skin graft in the receptacle, in one embodiment. The receptacle functions as a biological docking station for organizing partial skin segments in a lateral orientation with the receiving bed.

For other intact and visible skin scars, embodiments include the option of first forming the partially harvested skin segments into a more uniform graft than in a mechanical docking station. 137 illustrates an exemplary docking station including a docking tray and an adjustable slide in accordance with an embodiment. In this clinical setting, “upward angiogenesis” occurs in the deep aspect of the dermis in the receiving bed (eg, FIG. 136 ). In each clinical setting, compression stent dressings provide additional support and fixation to promote angiogenesis or promote skin grafting.

Since the advent of bovine collagen injectable fillers, the use of non-biological injectables has played a dominant role in the filler market. Examples described herein include novel collagen injectable filler compositions, the production and use of which include novel esthetic surgical excision of partial skin excision as detailed herein and in related applications. The novel filler of an embodiment of the present invention is referred to as, but is not limited to, a living autologous dermal matrix (LADMIX) injectable filler or “LADMIX”. LADMIX is a partially ablated skin plug (also referred to herein as a "pixel", "skin pixel" or "skin plug") is a biological composition that is a unique adjunct to partial ablation of the skin used as a donor tissue to make a living autologous dermal dermal injectable filler. Collagen injections are included. Although the dermal matrix does not "live" on its own, the presence of biofibroblasts in the injected filler results in continued production of collagen as a biochemical dermal filler. Because the filler material is present in the patient's own skin, resorption of the filler is minimized and the contour correction lasts longer than conventional artificial fillers. In addition, immune system or foreign body rejection is minimized or avoided.

138 depicts a face with target tissue including, for example, furrows and wrinkles. LADMIX injections offer significant advantages in these commonly occurring aesthetic modifications. In embodiments herein, skin closures of partial resection that would otherwise be discarded are harvested from the skin surface. 139 illustrates a partially incised area (skin plug in situ) according to one embodiment. Parallel procedures of partial skin tightening and LADMIX filler injection are performed simultaneously, but are not limited thereto.

The skin plug is taken from the area partially incised by application of an adherent matrix, eg, a double-adhesive puncture tape, and/or is described in detail herein and in related applications. 140 is a detailed view of a partial skin excision scar harvest according to an embodiment. The external orientation of the epidermis is maintained during the harvesting process as detailed herein. Skin plugs can be harvested with a membrane attached directly to the dermal node, or the plug can be harvested to the membrane separately and then applied to the dermal node. 141 shows an example with a skin plug harvested using a membrane attached directly to the drum dermis.

As detailed herein, FIG. 142 illustrates the removal of an epidermal component by converting a skin plug created by the dermis to an outrigger blade of the dermis, according to one embodiment. 143 depicts individually harvested skin plugs on a membrane, wherein the membrane is applied to a dermal node (eg, a drum) in one embodiment.

Harvested skin plugs are collected for mogelization with a LADMIX formulation or composition. The device used for mogelization is configured to mechanically plug the skin into a viscous liquid that minimizes fibroblast cell destruction. 144 illustrates an uncompressed mogelizer configured to mechanically scrape a skin plug with a viscous liquid in accordance with one embodiment.

The LADMIX formulation is mounted in a syringe with a large injectable needle. Prior to injection, a local anesthetic (eg 1% xylokine with epinephrine) is injected into the sulcus of the wrinkle/belly deformity. Local anesthetic injection provides anesthesia and lifting of the furrow to facilitate LADMIX filler injection. LADMIX filler injection is performed with a needle tip-down syringe and a large diameter needle. The needle tip is inserted into, but is not limited to, the longitudinal axis of the groove. 145 illustrates implantation of LADMIX filler in a target tissue region according to one embodiment. Advancement of the needle along the malformed furrow will automatically disengage the filler pocket while LADMIX filler is being injected. The injected autologous filler is manually massaged into a smooth surface contour. Steristrips are then applied to the implanted furrow stent and the corrected surface contour is maintained.

An exemplary embodiment of a scalpel device includes a multi-scalpit array comprising a multifunction chamber and is configured for simultaneous ablation and collection of multiple pixels. A collection chamber, also referred to herein as a "chamber", is configured to preserve the viability and volume of the self-injectable filler, and is also configured to provide one or more functions, for example, to act as a collection chamber, and also to ablated pixels to name a few. a collection chamber or outlet for, a mincing chamber for mincing the collected skin plug, a mixing chamber for mixing the minced tissue with a hyaluronic acid or saline solution, and/or a transfer container for transferring the minced pixel solution to a hypodermic injection line or to perform one or more functions including functioning as a loading station.

When configured or used for the collection chamber function, the multifunction chamber passively collects the harvested skin plug by pushing the plug into the chamber. At the end of this phase of the duty cycle, the multifunction port is configured for short duration vacuum extraction of the skin plug in the lumen of the scalpel. Otherwise, the chamber will remain at ambient atmospheric pressure, squeezing the viability of the skin plug. An “O-ring” is included in the distal region (eg, investing plate) of the central drive shaft to avoid retrograde gear particle contamination. A separate detachable (vacuum assisted) epidermal extraction chamber may be used first during the initial partial ablation procedure, although embodiments are not limited thereto.

The multifunction chamber contains a rotating mincing blade coupled or attached to a central drive shaft when configured or used for mincing chamber function. In the harvesting phase of the duty cycle, the central scalpel drive shaft and the mower blade are retracted proximally to avoid constantly clipping the harvested skin plugs. During the refinement phase of the duty cycle, the central drive shaft and the sewing machine blade are advanced in the distal direction for a predetermined period of time.

The multifunction chamber, when configured or used for a mixing chamber function, receives a carrier fluid through a syringe through the multifunction chamber port. The carrier fluid may include, for example, one or more of physiological saline such as dermal growth factor, hyaluronic acid, a hydrogel, and a bioactive factor.

When configured or used for syringe loading chamber function, the multifunction chamber is configured to draw or extract the minced composition into the syringe through the multifunction port for subsequent injection into a target or receptacle.

In particular, FIG. 146 shows an example of a scalpel device comprising a multifunction chamber under one embodiment. The multi-scalpit array of the scalpit device of this exemplary embodiment includes, but is not limited to, a centerless 3x3 multi-scalpit array configured for ablation and collection of 8 pixels simultaneously. The device is a hand piece coupled to or comprising a central drive shaft or pinion that is connected to a drive system (eg, a gear, etc.) and drives the rotation of eight scalpels (no scalpels at the center position of the 3x3 array). includes A vacuum is applied through a vacuum port of the drive chamber housing (eg, a gear box, etc.) to minimize and/or eliminate movement of the pixel array, although embodiments are not limited thereto. The collection chamber or chamber may be, for example, a collection container for ablated pixels, a mixing chamber for micro-mixing the pixels with a hyaluronic acid or saline solution, and/or a transfer container for transferring the minced pixel solution to a hypodermic line. configured to perform one or more functions, including acting. The size (eg, diameter, etc.) of the collection chamber is selected based on, for example, the amount or number of pixels to be collected in the collection chamber.

The housing includes or is coupled to an end cap at the distal end of the scalpel device, wherein the end cap in one embodiment is removable, but is not limited thereto. The length of the end cap may vary depending on the desired depth of ablation. Optionally, the end cap is attached via an internal spring configured to extend the end cap over the scalpel when not in use. When the end cap is installed, the vacuum tube is connected to the vacuum port on the drive system housing. This ensures effective removal of all gear swarf and, in combination with the mesh buffer plate, ensures that the ablated pixels are free of unnecessary material. The scalpel device and/or vacuum is configured to draw, but is not limited to, the ablated pixel through the scalpel (eg, the lumen and proximal end region) into the collection chamber. 147 depicts an exemplary vacuum flow path through a scalpelpit device, according to an embodiment.

148 depicts an exemplary scalpel device following collection of pixels within a collection chamber, according to one embodiment. After a portion of the harvesting process and/or collection in the chamber of sufficient skin plugs or pixels has been completed, the hand piece with the attached scalpel array is inverted to allow the pixels to be collected at the proximal end of the collection chamber. The end caps are removed and the vacuum fittings and captive screws are replaced with two plugs.

149 shows an inverted hand piece with a pixel in the collection chamber according to one embodiment. The collection chamber is configured to contain or contain saline and/or other desired solutions or compositions to be added to the pixel. A replacement end cap with a Luer or similar fitting plug is attached and the hand piece is returned with the chamber to its original orientation. 150 illustrates an inverted hand piece with a replacement end cap and fitting plug installed in accordance with one embodiment.

The hand piece is then removed from the chamber equipped with the mincing blade and then reattached to the collection chamber. 151 depicts a hand piece having a fine blade attached and positioned within a collection chamber with a pixel solution, according to one embodiment. Form the LADMIX filler by fine-tuning the pixel solution to the desired consistency using a fine blade. The mincer is removed and the syringe is attached to the end cap. The LADMIX filler is drawn into the syringe from the collection chamber and the LADMIX filler is ready to be injected into the target tissue area using a needle attached to the syringe. 152 shows a LADMIX filler inhaled into a syringe according to an embodiment. 153 shows a syringe and an attached needle prepared for injecting LADMIX filler into a target tissue area according to an embodiment.

In an embodiment for use in the preparation of LADMIX, the step of harvesting the tissue comprises removal of the epidermis to avoid the development of epidermal cysts at the receiving injection site. Removal of the epidermis and harvesting of the skin plug is accomplished using methods including, but not limited to, one or more of exfoliation of the epidermis, exfoliation of the epidermis, vacuum assisted two pass techniques, and two pass techniques including implantation. Each of these methods is described in detail below.

Epidermal exfoliation from the dermis involves blistering of the skin within an entire partial area or at individual partial locations. 154 illustrates a skin blister formed within an entire partial area according to an embodiment. 155 illustrates a partial region after removal of blistered tissue covering the entire partial region, according to an embodiment. 156 illustrates the formation of multiple skin blisters under one embodiment. 157 illustrates a plurality of subregions after removal of blistered tissue overlying the subregions, according to one embodiment. The blistering of the embodiment is performed using thermally assisted vacuum assisted mechanical vibration shearing. Blistering in another embodiment is performed using vacuum assisted mechanical vibration shearing without heat. Another embodiment for skin blister formation involves superficial injection of a local anesthetic or normal saline at the epidermal/dermal junction using a short multi-needle injection manifold. Additional alternatives include, but are not limited to, vacuum assisted and/or mechanical shearing and/or heat.

After blistering of the skin, skin plug anesthesia is applied in a single pass of either a single Scalpit system or multiple Scalpit plate arrays as detailed herein. 158 depicts harvesting skin plugs within a blistered area using a single scalpel system or multiple scalpel arrays according to one embodiment.

An alternative embodiment of the epidermal removal and skin plug harvesting comprises epidermal dermabrasion from the dermis. The entire partial partial donor area is ground to skin with a standard skin abrasive system, although the examples are not so limited. Optionally, removal of the epidermis is performed by epidermal treatment of each individual partial region using a small rotating burr driven by a single scalpel-fit console as described herein.

Another embodiment of removing the epidermis and harvesting the skin plug involves the use of a vacuum assisted two pass method or process. A first partial resection is performed superficially to remove the epidermis and a small portion of the papillary dermis (inclusion of the papillary dermis with harvested skin plugs is important when a higher density of fibroblasts is present in that portion of the skin layer). A second partial harvest pass is performed full thickness through the dermis. The elastic recoil of the skin scar margin of the first partial pass provides additional clearance of the partial scar skin edge for the second harvest pass. As in other methods described herein, the dissected skin plug is evacuated and collected, for example, into an inline scalpel volume collection vessel.

Embodiments of the vacuum assisted two pass method include additional methods of providing epidermal margin clearance. This additional margin removal method is used in the second partial harvesting process where the scalpel/array is first inserted into the partial scar without rotation. Once fully inserted into the partial scar of the first pass, rotation of the console begins for the second harvest pass.

Another embodiment for removing the epidermis and harvesting the skin plug involves the use of a vacuum assisted two pass method with superficial injection of a local anesthetic or normal saline. The method minimizes unwanted excision of the papillary dermis during the first pass.

Regardless of the method used to remove the epidermis and harvest the skin plugs, the harvested skin plugs are harvested into a collection vessel as described here. 159 depicts a collection container or canister comprising harvested skin plugs under one embodiment. When harvest is complete, the skin plug is removed from the collection container and placed in a mincer container. 160 shows a mincer container or canister containing harvested skin plugs under one embodiment. The mincer container is configured for, but is not limited to, slicing or cutting a dermal plug into small pieces configured for injection.

Mincing of the examples is performed with minimal trauma to preserve viable fibroblasts. For this purpose, mincers contain one or more of manual, rotating, vibrating and reciprocating ultra-sharp blades without compression mogelization. 161 illustrates a manual mincer comprising a blade arrangement configured to be manipulated up/down/left/right and/or rotationally, according to one embodiment. 162 depicts an electric mincer including a blade or cutting device configured to be rotated with electric power according to one embodiment. Rotation is imparted to the blade arrangement by, but not limited to, one or more electric motors, air motors and hand or mechanically actuated devices.

The mincer container of an embodiment is also configured for use as a mixing chamber in which a carrier fluid/gel is added to skin tissue. The carrier fluid of an embodiment comprises one or more of hyaluronic acid, a hydrogel, and normal saline, to name but a few. To reduce surface loss and trauma to the injectable, the mincing container of one embodiment is configured as a loading chamber including a plunger and a port for loading the bioautologous composition directly into an infusion syringe. Prior to injection into the receptacle, the syringe may also be placed on a centrifuge to separate the liquefied fat from the dermal composition. Reduced friction syringes (eg, glass, plastic, etc.) are used to further reduce trauma to the autologous composition during injection.

The LADMIX harvest of one embodiment is configured to enable the use of ablated skin in cosmetic surgery procedures such as facelifts, abdominoplasty, mammoplasty, and/or breast reduction. The combined procedure of one embodiment includes, but is not limited to, placing (and attaching) the ablated skin to the padjet dermis using a membrane tape applied during the same cosmetic surgery procedure.

The skin is oriented down with the epidermis in contact with the dermal tape, but is not limited thereto. The epidermis is removed by setting the dermis in a superficial setting. The subcutaneous tissue may be manually removed in a second pass with instrument degreasing or deep setting dermabrasion. The isolated skin layer of the ablated skin is minced as described.

Infusion of LADMIX is performed in the Examples at the same procedure or time as, but not limited to, partial skin excision. Combining these two procedures into a single procedure provides unique features for aesthetic enhancement. The combined procedure also provides a unique ability for the treatment of depressed scar deformation in which a bio skin composition is harvested in the area of partial scar correction. This procedure can also be applied to certain physiological disease states that can be identified, one of which is the treatment of stress incontinence in women.

A procedure or method using LADMIX is adapted for application to a variety of clinical methods or applications, including, but not limited to, one or more of aesthetic, reconstructive scarring, and physiological disease conditions. Typically, the procedure involves taking or obtaining detailed preoperative pictures of the patient or subject. The patient is shown preoperatively or in a standing position. For example, a 4:1 rule is used to determine the overall size of a partial ablation area, although embodiments are not limited thereto. The portion marked with a smaller shape in this area can also be used as a donor site for harvesting skin plugs.

Preoperative sedation and prophylactic antibiotics are provided to the patient and/or procedure as appropriate (eg, intravenously, buccal, etc.), and the patient is transferred to the operating room to administer an anesthetic appropriate for the surgical procedure. The surgical area is prepared and draped in a sterile manner. Local field or tumescent anesthesia is injected into the surgical area. A solution of xylocaine diluted with epinephrine (e.g., 0.5% xylokine with 1 in 200,000 parts of epinephrine for area block for tumescent anesthesia, or 0.25% xylocaine with 1 of 400,000 parts of epinephrine for an area block Silocaine) is used to provide anesthesia (and vasoconstriction to reduce bleeding).

A marking system template or stencil is then applied to the surgical area. The marking system template of an embodiment includes a perforated and notched plate configured to use the edge of the plate to distinguish appropriate partial density ablation at the donor site. 163 is an example of displaying a system template according to an embodiment. The peripheral notch is configured for orientation during template application, and the perforation marks the density of the partial ablation, with which the surgeon is free to "fill" the mid-section ablation. Also, the marking template is configured to, for example, mark the working area with ink, or use partial marking ablation directly through a larger hole in the template.

Partial ablation of one embodiment includes a staggered technique of partial ablation to reduce the delineation of rows and columns of partial ablation areas. Within the donor region of the region, the two-pass technique described above is used for skin harvesting. The partial area is then finished with Flexzan or other elastic absorbent material with a directed closure vector that provides maximum aesthetic contouring. A sterile dressing is then applied to the skin/fatectomy/dermis donor site.

The harvested skin plugs are then processed and injected into previously marked receptacles during the same procedure to preserve the viability of autologous blood fillers. After injecting the local anesthetic, the large-diameter needle of the syringe is first advanced along the length of the marked malformation to create a pocket for receiving the injection. 164 illustrates the creation of a receiving pocket for an injectable pocket in one embodiment. The large bore needle is slowly retracted while the automatic filler is injected along the entire length of the created pocket. 165 shows a receiving pocket with an implanted filler in one embodiment.

More specifically, exemplary procedural protocols involving LADMIX injections are described in detail. During the patient's pre-surgery waiting, the donor and receiver are marked. In this example the donor site comprises the opaque lower right quadrant (RLQ) of the abdomen. The receptacle becomes the dorsal and appendectomy scar of the left hand at RLQ.

A subcutaneous electric field block (eg, 0.5% xylocaine with 1 in 200,000 parts epinephrine) is administered to the donor site of the abdominal RLQ when the patient is in the operating room. Other agents injected superficially at the bordering epidermal junction (without the epidermis) are also administered throughout the bordering region. Receive a standard subcutaneous area block using the same local anesthetic on both the back of the left hand and the recessed resection scar. The donor and receiver are prepared and draped in a sterile state.

The first pass of partial ablation at the donor site is performed with a depth stop/vacuum manifold (e.g., 1 mm depth stop/vacuum manifold) using a scalpel (e.g., 2 mm inner diameter) without an inline filter in the vacuum line. . The initial pass is performed to remove the epidermis, possibly with little papillary dermis.

A second dermal harvest pass at the donor site is an inline filter with a depth stop/vacuum manifold (e.g., 4-6 mm deep stop/vacuum manifold) using a scalpel fit (e.g., 1.5 mm inner diameter). is carried out The filter should be inserted as close to the manifold as possible. The scalpel/manifold is regularly washed with saline to collect and hydrate all harvested skin plugs.

The harvested skin plug is removed from the filter and placed in a mincer to which a small amount of saline is added. Autologous tissue is made by mincing the dermal plug with saline, but is not limited thereto. The composition is loaded (by aspiration) into a filler injection syringe using a short blunt tip 17-gauge needle. The composition is then injected into the receptacle using a 22 gauge cannula.

A sample of the composition is first applied to a microslide for biostaining to determine the viability of the harvested fibroblasts. For example, using a technique developed by Dr. Stephen Yoelin, the first receptor is injected into the dorsal side of the left hand. To create a pocket, the cannula is first advanced without injection. The composition is then injected when the cannula is withdrawn in a retrograde fashion within the pocket.

The second receptacle of the recessed resection scar is injected after the first receptacle is injected when an appropriate amount of the injection is available. After 3 months, the injected appendectomy scars are excised for histological evaluation to determine the long-term biostructure and viability of the injected composition.

For example, directed closure of RLQ donors as determined by the Langer line is accomplished with the application of Flexzan using a single mooring technique. Both receiving injections are manually manipulated to smooth the contours. A stereo strip (1/2 inch) is applied longitudinally to the receptacle with the stent. A standard 4x4 dressing and ABD pad are applied over the donor's Flexzan.

Clinical applications of the LADMIX fillers described herein include, but are not limited to, aesthetic applications, reconstitution applications, and physiological applications. Aesthetic applications include, but are not limited to, furrows, wrinkles, relief, and general aesthetic contours. The furrows contain aesthetic modifications due to attachment to the facial muscles and are emphasized during the activation of the anatomical area. Glabellar sulcus is the most frequently referenced aesthetic sulcus malformation. The LADMIX composition is used to treat the furrow, for example by injecting a lower LADMIX between the skin and muscle.

Wrinkles are mostly caused by linear atrophy of the skin collagen matrix. Epidermal endothelial injection of LADMIX is effective for long-term improvement of aesthetic modifications.

A prominent part of the wrinkles, especially the nasolabial fold, is due to the gradual skin relaxation of this structure. A younger transition between these two structures is possible by injecting LADMIX into the upper lip and alar groove along the edge of the nasal lip fold.

As for general aesthetic contouring, for women, the prominent scarlet speckled upper arm can be socially interpreted as aesthetically enhanced. LADMIX injections provide long-term highlighting of the anatomy along the scarlet skin junction of the upper extremities. There is also the potential for long-lasting lip enhancement.

Reconstructive applications of LADMIX include, but are not limited to, applications involving scarring and soft tissue contour deformation. In addition, this application requires an understanding of the anatomical base of the anomaly.

For example, a recessed scar anomaly results in scarring in a deep tissue layer. In most cases, release of the underlying scar attachment is required during the same procedure, including subcutaneous injection of the LADMIX composition.

Many recessed soft tissue contour anomalies are due to traumatic lipolysis of the subcutaneous fat layer. After the release of the recessed malformation, the injection should be between the skin and the subcutaneous tissue below.

Physiological applications of LADMIX include, but are not limited to, female urinary incontinence, gastroesophageal reflux, and vocal cord negative control. When applied to treat urinary incontinence in women, injection of bioautologous collagen fillers retains the physiological support of the syringe longer than non-viable xenogeneic injections. 166 illustrates female urinary incontinence treatment using LADMIX infusion, according to one embodiment.

Patients with gastroesophageal reflux disease are resistant to pharmacological management that reduces gastric acidity. Injections of various curing agents are attempted with mixed results. Injection of LADMIX into the peripheral esophageal sphincter reduces reflux of gastric contents. The combination of pharmacological management of gastric acidity and endoscopic LADMIX injection (as a physical obstacle) can synergistically reduce symptoms and gastroesophageal reflux.

The LADMIX described here is used in clinical applications for vocal chord voice modulation. Incomplete or incomplete arrangement of the vocal cords can lead to various voice disorders. Submucosal injection of LADMIX into the vocal cords provides positive negative modulation in selected patients.

An embodiment includes a method comprising:

confirming whether to donate to the patient; removing a portion of the epidermis in the donor site; harvesting a plurality of skin plugs within the donor site; mincing the skin plug to form an injectable filler; And, injecting the injectable filler into the receiving part of the patient. The acceptor is different from the donor.

An embodiment comprises a step comprising:

confirming whether to donate to the patient;

removing a portion of the epidermis in the donor stomach; harvesting a plurality of skin plugs within the donor; mincing the skin plug to form an injectable filler; and injecting the subcutaneous injection into the receiving part of the patient. The receiving part is different from the donor part.

The injectable filler includes a living autologous dermal matrix (LADMIX) injectable filler.

Injectable fillers contain living fibroblasts.

Removing the epidermal portion includes removing the epidermal portion in the region of the donor site.

Removing the epidermal portion includes removing the epidermal portion in a plurality of regions of the donor site.

Removing the portion of the epidermis includes exfoliating the epidermis from the dermis in at least one region of the donor site.

Exfoliation involves blistering of the skin.

Exfoliation involves blistering of the skin at the donor site.

Delamination includes vibration shearing.

The vibration shearing includes at least one of vacuum and heat.

Exfoliation includes surface implantation.

The superficial injection includes at least one of saline and anesthetic.

Removing the portion of the epidermis includes exfoliating the epidermis from the dermis in at least one region of the donor site.

Harvesting the plurality of skin plugs includes partially excising at least one skin plug from at least one region of the donor site.

Harvesting the plurality of skin plugs includes partially excising at least one skin plug from each of the plurality of regions of the donor site.

Harvesting the plurality of skin plugs includes at least one partial excision at the donor site.

The at least one partial ablation application includes staggered partial ablation applications at the donor site.

The at least one partial ablation application at the donor site comprises a first partial ablation application and a second partial ablation application.

The first partial ablation involves removal of the epidermis.

The second partial ablation application comprises partial ablation through the dermis.

The second ablation comprises a partial thickness partial ablation through the dermis.

The second partial resection comprises a full thickness partial resection through the dermis.

The partial scar skin edge of the second partial ablation application includes an additional gap to the partial scar skin edge of the first partial ablation application.

The method includes inserting at least one scalpel into at least one donor region and rotating the at least one scalpel when fully inserted.

The partial ablation includes positioning a housing comprising a scalpel assembly in a target area, wherein the scalpel assembly includes an array of scalpels and at least one guide plate, the array of scalpels including a plurality of scalpels and the at least one guide plate maintains the configuration of the plurality of scalpels.

At least one scalpel of the array of scalpels includes a cylindrical scalpel comprising a cutting surface at a distal end of the scalpel.

Partial ablation includes disposing the scalpel array from the housing into tissue in the target area, and upon deployment creating a plurality of incised skin plugs in the target area, wherein deployment utilizes forces of a drive system of the scalpel assembly to operate on the scalpel array binding to.

The partial ablation includes applying a rotational force to the scalpel array, wherein the rotational force is configured to rotate the at least one set of the plurality of scalpels.

The plurality of scalpels are configured to passively extrude the skin plug through the plurality of lumens of the plurality of scalpels.

The method includes delivering a vacuum to the target area through the housing, the vacuum comprising a pressure relatively lower than ambient air pressure, and using the vacuum to capture the plurality of incised skin plugs. includes steps.

Partial dissection involves retracting the scalpel array from the target area into the housing.

The method includes capturing a plurality of incised skin plugs using an adherent matrix.

The method includes severing the ablated skin plug using a cutting member.

Partial ablation comprises applying a scalpel pit array to a target skin region, the scalpel pit array comprising a plurality of scalpels positioned on an investing plate, wherein the investing plate is a perforated plate. .

Partial ablation involves a skin plug that incises circumferentially in a target skin area by applying a load through a scalpel array onto an underlying skin surface comprising the target skin area.

Applying the load includes applying the load to the ligament.

Fistula include flat sclerites.

Fibrils include drum pits.

Partial ablation includes capturing a plurality of ablated skin plugs on an adherent matrix, wherein the ablated skin plugs are extruded through a scalpelfit array.

The method includes linking an adherent substrate to a ganglion.

Partial ablation involves excising the base of a dissected skin plug extruded through a scalpelfit array.

Cutting includes cutting with a cutting member.

The cutting member is coupled to the drum segment.

The method includes collecting a plurality of skin plugs harvested from the donor site.

The method includes collecting a plurality of skin plugs in a collection chamber coupled to the scalpel array.

the collection chamber is configured for at least one of receiving the skin plug, collecting the skin plug, mincing the skin plug, and mixing the skin plug with the carrier, the loading chamber receiving at least one composition comprising the skin plug for loading into the needle and infusion cannula of

The collection chamber includes a pressurization chamber.

The collection chamber includes a non-pressurized chamber.

The collection chamber is configured for mincing, wherein the mincing includes mincing a skin plug within the collection chamber.

The harvesting step includes partial ablation applying a rotational force to the scalpel pit array, and the mincing step includes mincing the skin plug in the collection chamber with at least one blade configured to rotate by the rotational force.

The step of forming the injectable filler includes mixing the minced skin plug with a carrier, and the collection chamber consists of a mixing chamber for mixing.

Infusion comprises injecting using at least one of a needle and an infusion cannula, wherein the collection chamber consists of a loading chamber for at least one of the needle and infusion cannula.

The collecting step includes emptying the plurality of skin plugs from the donor site.

The mincing includes mincing the skin plug with one or more blades.

The minshing includes at least one of manual mincing and power mincing.

Minshing includes rotary mincing.

Minshing includes round-trip mincing.

Minshing includes vibratory mincing.

Minshing excludes compression mincing.

Mincing involves compressive mogelization.

Formation of the injectable filler includes mixing the minced skin plug with a carrier.

The carrier contains a fluid.

The carrier comprises a gel.

The carrier contains hyaluronic acid.

The carrier comprises a hydrogel.

The carrier contains saline.

The carrier includes a bioactive agent.

The bioactive agent includes dermal growth factor.

The method comprises centrifugation of the injectable filler.

Injection includes injecting from a syringe.

Injection is performed simultaneously with removal.

Injection is performed during the same procedure as removal.

The donor site consists of an area within a larger surgical field.

Checking the donor site includes applying the template to the surgical unit in the donor site.

The template is configured to indicate the surgical section.

The template includes at least one of a perforation and a peripheral notch.

The perforation is configured to indicate at least one density for the plurality of skin plugs.

The peripheral notch is configured to direct subsequent application of the template.

Marking includes marking the surgical area with at least one of an ink and a dye through the perforations.

Marking includes direct partial marking ablation through perforation.

The method includes, after harvesting, applying at least one bandage at the donor site.

One or more bandages apply force to close the target area.

At least one bandage applies a directional force that controls the direction of closure of the target area.

Injection involves creating a pocket in the donor site for injectable filler.

The method includes pocketing an injectable filler.

Injection involves advancing a needle and injecting an injectable filler.

Injection includes creating a pocket by advancing at least one of the needle and the infusion cannula into an area adjacent the receptacle.

Injection involves withdrawing the needle from the pocket while injecting the injectable filler.

The receptacle includes an aesthetic transformation.

The receiving portion includes at least one of a furrow, a pleat, and a fold.

The receptacle contains the scarlet skin junction of the upper labia.

The receptacle includes at least one of a scar and an indented scar.

The receptacle includes at least one of contour deformation, soft tissue contour deformation, and post-traumatic depression contour deformation.

The receptacle includes at least one region adjacent to at least one of the urethra and the bladder.

The receptacle includes at least one region adjacent the esophageal sphincter.

The receptacle includes at least one region near the vocal cords.

Embodiments include methods comprising removing a portion of an epidermis in a donor site of a patient. The method includes harvesting a plurality of skin plugs within the donor site. The method includes mincing a skin plug to form an injectable filler. The method includes configuring an injectable filler for injection into a receptacle of a patient. The acceptor is different from the donor.

Embodiments include removing a portion of the epidermis within a donor site of a patient; harvesting a plurality of skin plugs within the donor; mincing the skin plug to form an injectable filler; and the receptacle configuring the injectable filler for injection into a receptacle different from the receptacle.

An embodiment includes a method comprising the step of excising skin from a donor site in a patient. The method includes removing a portion of the epidermis from the ablated skin. The method includes removing the subcutaneous tissue to isolate the dermal layer of the ablated skin. The method includes forming an injectable filler by mincing a skin layer. The method includes injecting an injectable filler into a receptacle of a patient. The acceptor is different from the donor.

Embodiments include excising skin from a donor site in a patient; removing a portion of the epidermis from the excised skin; separating the dermal layer of the excised skin by removing the subcutaneous tissue; mincing the dermal layer to form an injectable filler; and injecting the subcutaneous injection into a receiving unit of the patient, wherein the receiving unit is different from the donor unit.

Embodiments include compositions comprising a plurality of skin plugs harvested from tissue of a patient at a donor site. The skin plug is minced. The composition comprises a carrier comprising at least one of a fluid and a gel. The carrier is mixed with the minced skin plug to form an injectable filler. The injectable filler is configured for injection into a patient.

Embodiments include a plurality of skin plugs harvested from tissue of a patient at a donor site, wherein the skin plugs are minced. a carrier comprising at least one of a fluid and a gel, wherein the carrier is mixed with the microporous stopper to form an injectable filler, the injectable filler being configured for injection into a patient.

Injectable fillers include living autologous dermal matrix (LADMIX) injectable fillers.

Injectable fillers contain living fibroblasts.

A plurality of skin plugs are harvested from a plurality of donors.

A plurality of skin plugs are harvested directly from the patient.

A plurality of skin plugs are harvested from tissue following tissue removed from the patient.

The plurality of skin plugs excludes the epidermis.

The epidermis is removed from at least one region of the donor site.

The epidermis is removed by exfoliating the epidermis from the dermis in at least one area.

Exfoliation consists of blistering of the skin.

Delamination includes vibratory shearing.

The vibration shearing includes at least one of vacuum and heat.

Exfoliation includes surface implantation.

The superficial injection includes at least one of saline and anesthetic.

The skin is removed by the epidermis.

The plurality of skin plugs is harvested by partially excising at least one skin plug from at least one region of the donor site.

The plurality of skin plugs are harvested by partially excising at least one skin plug from each of the plurality of regions of the donor site.

The plurality of skin plugs are harvested through at least one partial ablation application at the donor site.

The at least one partial ablation application includes staggered partial ablation applications at the donor site.

The at least one partial ablation application includes a first partial ablation application and a second partial ablation application.

The first partial ablation application includes epidermal removal.

The second partial ablation application comprises partial ablation through the dermis.

The second partial ablation comprises a partial partial thickness partial ablation through the dermis.

The second partial resection comprises a full thickness partial resection through the dermis.

The partial scar skin edge of the second partial ablation application includes an additional gap to the partial scar skin edge of the first partial ablation application.

At least one scalpel is inserted into the at least one donor region and is rotated when fully inserted.

A housing including a scalpel assembly is positioned at a donor site, wherein the scalpel assembly includes an array of scalpels and at least one guide plate, the array of scalpels including a plurality of scalpels, the at least one guide plate comprising: Maintain the configuration of multiple scalpels.

At least one scalpel of the array of scalpels includes a cylindrical scalpel comprising a cutting surface at a distal end of the scalpel.

An array of scalpels is placed from the housing into the tissue of the donor site, and a plurality of skin plugs are created at the donor site.

At least one set of a plurality of scalpels is rotated.

The plurality of skin plugs are passively extruded through the plurality of lumens of the plurality of scalpels.

The plurality of skin plugs are captured by a vacuum at the donor site, the vacuum comprising a pressure relatively lower than atmospheric pressure.

The scalpel array is retracted into the housing at the donor site.

A plurality of skin plugs are captured using an adhesion matrix.

The incised skin plug is incised using a cutting member.

An array of scalpels is applied to a donor site, wherein the array of scalpels includes a plurality of scalpels positioned on an investing plate.

A plurality of skin plugs are circumferentially incised at the donor site through a load applied by the scalpel array at the underlying skin surface comprising the donor site.

The load is applied to the dermis.

The ganglion includes at least one of a flat ganglion and a drum ganglion.

A plurality of skin plugs are extruded through the scalpel fit array, and the plurality of skin plugs are captured on an adherent matrix.

The adherent matrix is bound to the cortex.

The bases of the plurality of skin plugs extruded through the scalpel fit array are incised.

The bases of the plurality of skin plugs extruded through the scalpel pit array are cut with a cutting member coupled to the drum dermis.

A plurality of skin plugs are collected in a collection chamber coupled to the scalpel array.

The collection chamber includes the steps of receiving the plurality of skin plugs, collecting the plurality of skin plugs, mincing the plurality of skin plugs, mixing the plurality of skin plugs with a carrier, a needle and an injection catheter. and loading a composition comprising a plurality of skin plugs into at least one of the nuclei.

The collection chamber includes at least one of a pressurized chamber and a non-pressurized chamber.

A plurality of skin plugs are minced in a collection chamber.

A plurality of skin plugs are minced with a rotating blade.

The carrier is mixed with the minced skin plug in a collection chamber.

At least one of the needle and infusion cannula is used for infusion, and the collection chamber is configured as a loading chamber for one or more of the needle and infusion cannula.

The plurality of skin plugs are minced with at least one blade.

The minshing includes at least one of manual mincing and power mincing.

The mincing includes at least one of rotary mincing, reciprocating mincing, vibration mincing, and compression mogelization.

Minshing excludes compression mincing.

The carrier comprises at least one of a fluid and a gel.

The carrier includes at least one of hyaluronic acid, a hydrogel, and saline.

The carrier includes a bioactive agent.

The bioactive agent includes dermal growth factor.

The injectable filler is centrifuged.

The injectable filler is injected from a syringe.

Injectable fillers are injected during the same procedure as harvesting multiple skin plugs.

The donor site includes an area within the larger surgical area.

The template is applied to a donor site, wherein a plurality of skin plugs are harvested at the donor site.

Donations are indicated using templates.

The template includes at least one of a perforation and a peripheral notch.

The perforation exhibits at least one density for the plurality of skin plugs.

The peripheral notches are oriented towards subsequent application of the template.

The donor site is indicated through perforation using at least one of an ink and a dye.

Donor sites are marked using direct partial marking resection through perforation.

At least one bandage is applied to the donor site after harvesting the plurality of skin plugs.

Closure is applied by at least one bandage.

A directional force is applied by the at least one bandage to control the direction of closure.

The injectable filler is configured to be injected into a receptacle of a patient, wherein the receptacle is different from the donor site.

A pocket is created in the receptacle for receiving the injectable filler.

The pocket is generated when at least one of the needle and the infusion cannula is advanced into an area adjacent the receptacle.

The injectable filler is injected into the pocket using at least one of a needle and an infusion cannula.

The receptacle is at least one region adjacent to at least one of aesthetic anomaly, furrow, wrinkle, fold, scarlet skin connection region of upper lip, scar, inverted scar, contour deformity, soft tissue contour deformity, post-traumatic inverted contour deformity, urethra and bladder, esophagus at least one region adjacent the sphincter, and at least one region adjacent the vocal cords.

Embodiments include a system including a hand piece configured to be removably coupled to a proximal end of a housing. The hand piece includes a drive system. The system includes a scalpel assembly configured to be removably coupled to a distal end of the housing and a drive system. The scalpel assembly includes an array of scalpels including a plurality of scalpels configured to rotate using force transmitted from the drive system. The scalpel array is configured to harvest a plurality of skin plugs from a donor site via partial resection. The system includes a collection chamber coupled to the housing and configured to collect a plurality of skin plugs generated by the scalpel assembly.

The collection chamber is further configured to accommodate the formation of an injectable filler by mincing the skin plug and mixing the skin plug with a carrier. The injectable filler is configured for injection into a patient.

Embodiments consist of a system comprising:

a hand piece configured to be removably coupled to a proximal end of the housing, the hand piece including a drive system; a scalpel assembly configured to removably connect to the distal end of the drive system and housing, the scalpel assembly comprising a scalpel array comprising a plurality of scalpels configured to rotate using a force transmitted from the drive system; the scalpel array is configured to harvest the plurality of skin plugs from the donor site via partial resection; and a collection chamber coupled to the housing and configured to collect a plurality of skin plugs produced by the scalpel assembly, wherein the collection chamber comprises an injectable filler by mincing the skin plug and mixing the skin plug with a carrier. and wherein the injectable filler is configured for injection into a patient.

Injectable fillers include living autologous dermal matrix (LADMIX) injectable fillers.

Injectable fillers contain living fibroblasts.

The carrier comprises at least one of a fluid and a gel.

The carrier includes at least one of hyaluronic acid, a hydrogel, and saline.

The carrier includes a bioactive agent.

The bioactive agent includes dermal growth factor.

The housing includes a vacuum port configured to be coupled to a vacuum source, the vacuum including a pressure relatively lower than atmospheric pressure, and the housing configured to use the vacuum to capture the plurality of skin plugs.

A plurality of skin plugs are collected in a collection chamber.

The collection chamber includes at least one of a pressurized chamber and a non-pressurized chamber.

The system comprises an end cap configured to removably couple to a distal end of the housing, the end cap comprising a fitting configured to couple to at least one of a medical instrument and a plug, the end cap being adapted to collection of a plurality of skin plugs. Then replace the scalp fit assembly.

Fittings include luer taper fittings.

The system includes a mincing blade configured to be removably coupled to the drive system for rotation using a force transmitted from the drive system, the mincing blade replacing the scalpel assembly after collection of the plurality of skin plugs.

A plurality of skin plugs are minced in a collection chamber.

The mincing blade includes one or more blades.

The minshing blade includes a plurality of blades.

The mincing includes at least one of rotary mincing, reciprocating mincing, vibration mincing, and compression mogelization.

Minshing excludes compression mincing.

The collection chamber is configured to load a composition comprising a skin plug into at least one of a syringe and an injection cannula connected to the fitting.

At least one of a syringe and an infusion cannula is used for infusion.

The injectable filler is injected during the same procedure as the harvesting of multiple skin plugs.

The injectable filler is configured to be injected into a receptacle of a patient, wherein the receptacle is different from the donor site.

A pocket is created in the receptacle for receiving the injectable filler.

The pocket is generated when at least one of the needle and the infusion cannula is advanced into an area adjacent the receptacle.

The injectable filler is injected into the pocket using at least one of a needle and an infusion cannula.

The receptacle may include at least one region adjacent to at least one of an aesthetic deformity, a furrow, a wrinkle, a fold, a scarlet skin connection region of the upper lip, a scar, an inverted scar, a contour deformity, a soft tissue contour deformity, a post-traumatic inverted contour deformity, the urethra and the bladder. , at least one region adjacent the esophageal sphincter, and at least one region adjacent the vocal cords.

An array of scalpels is placed from the housing into the tissue of the donor site, and a plurality of skin plugs are created at the donor site.

The plurality of skin plugs are passively extruded through the plurality of lumens of the plurality of scalpels.

A plurality of skin plugs are harvested from a plurality of donors.

The plurality of skin plugs excludes the epidermis.

The epidermis is removed from at least one region of the donor site.

The epidermis is removed by exfoliating the epidermis from the dermis in at least one area.

Exfoliation consists of blistering of the skin.

Delamination includes vibratory shearing.

The vibration shearing includes at least one of vacuum and heat.

Exfoliation includes surface implantation.

The superficial injection includes at least one of saline and anesthetic.

The skin removes the epidermis.

The plurality of skin plugs is harvested by partially excising at least one skin plug from at least one region of the donor site.

The plurality of skin plugs are harvested by partially excising at least one skin plug from each of the plurality of regions of the donor site.

The plurality of skin plugs are harvested through at least one partial ablation application at the donor site.

The at least one partial ablation application includes staggered partial ablation applications at the donor site.

The at least one partial ablation application includes a first partial ablation application and a second partial ablation application.

The first partial ablation application includes epidermal removal.

The second partial resection comprises partial resection through the dermis.

The second partial ablation comprises a partial partial thickness ablation through the dermis.

The second partial resection comprises a full thickness partial resection through the dermis.

The partial scar skin edge of the second partial ablation application includes an additional gap to the partial scar skin edge of the first partial ablation application.

At least one scalpel is inserted into the donor site and, when fully inserted, rotates.

The donor site consists of an area within a larger surgical field.

The system includes a template configured for application to a donor site.

Donations are indicated using templates.

The template includes at least one of a perforation and a peripheral notch.

The perforation exhibits at least one density for the plurality of skin plugs.

The peripheral notches are oriented towards subsequent application of the template.

The donor site is indicated through perforation using at least one of an ink and a dye.

Donor sites are marked using direct partial marking resection through perforation.

The system includes at least one bandage configured to be applied at the donor site after harvesting the plurality of skin plugs.

The one or more bandages are configured to apply an occlusive force.

The at least one bandage is configured to apply a directional force that controls a direction of closure.

The drive system includes a gear drive system.

The drive system includes a friction drive system configured to generate a friction force through at least one set of compressive elements of the plurality of scalpels, the friction force configured to rotate at least one set of the plurality of scalpels.

The drive system includes a helical drive system.

The drive system includes a slotted drive system including a drive rod configured to engage a slotted component of the scalpel array, the drive rod configured to move up and down relative to the scalpel shaped array.

The drive system includes a vibration drive system configured to vibrate at least one scalpel of the array of scalpels.

The scalpel assembly is configured to transmit an axial force to a target area.

The axial force includes at least one of a continuous axial force and an impact force.

At least one scalpel of the array of scalpels includes a cylindrical scalpel comprising a cutting surface at a distal end of the scalpel.

The cutting surface includes a sharp edge.

The cutting surface includes a serrated edge.

The cutting surface includes at least one radius of curvature.

The system includes a vibration system coupled to the scalpel array.

The system comprises an electromagnetic system coupled to the scalpel array and configured to couple the electromagnetic energy to the scalpel array, the electromagnetic energy comprising at least one of radio frequency (RF) energy, laser energy and ultrasonic energy. .

Throughout the description, unless the context clearly requires otherwise, the words "comprises", "comprising", etc. are to be construed in an inclusive sense as opposed to an exclusive or exclusive meaning, i.e., "including non-limitingly". interpreted as meaning Words using the singular or plural form also include the plural or singular form. Additionally, “herein,” “hereinafter,” “above,” “below,” and similar words, as used herein, refer to the entirety of this specification and any specific It does not refer to parts. When the word "or" is used with reference to a list of two or more items, the word includes all of the following interpretations: any of the items in the list, all items in the list, and any combination of items in the list.

The description of the above examples is not intended to limit the systems and methods to the precise form disclosed. For example, although specific embodiments of medical devices and methods have been described herein for illustrative purposes, it will be apparent to those skilled in the art that various equivalent modifications are possible within the scope of the systems and methods. The teachings of medical devices and methods provided herein may be applied to the systems and methods described above, as well as to other systems and methods.

Elements and acts of the various embodiments described above may be combined to provide further embodiments. These and other modifications may be made to the medical devices and methods with reference to the detailed description above.

Generally, in the following claims, the terminology used is not to be construed as limiting the medical devices and methods and corresponding systems and methods to the specific embodiments disclosed in the specification and claims, but is intended to include all systems operating under the claims. should not be interpreted Accordingly, the medical device and method and the corresponding system and method are not limited by this specification, and the scope is solely determined by the claims.

Although certain aspects of medical devices and methods and corresponding systems and methods are presented below in the form of specific claims, the inventors contemplate various aspects of medical devices and methods and corresponding systems and methods in any number of claim forms. . Accordingly, the inventors of the present invention reserve the right to add additional claims after filing an application to pursue such additional claims for other aspects of medical devices and methods and corresponding systems and methods.

Claims (248)

In the system,
housing;
a hand piece configured to be removably coupled to a proximal end of the housing and comprising a drive system;
a scalpel assembly configured to be removably coupled to a distal end of the housing and a drive system, the scalpel assembly comprising a scalpel array comprising a plurality of scalpels configured to rotate using a force transmitted from the drive system; wherein the scalpel array is configured to harvest a plurality of skin plugs from a donor site via partial resection;
a collection chamber configured to collect a plurality of skin plugs generated by the scalpel assembly in an interior region of the housing, and further configured to receive mincing and mixing of the skin plug and carrier;
an end cap removably coupled to the distal end of the housing and configured to replace the scalpel assembly after collection of the plurality of skin plugs; and
and a mincing blade removably coupled to the drive system and configured to replace the scalpel assembly after collection of the plurality of skin plugs. The system of claim 1 , wherein the collection chamber is configured to contain the formation of an injectable filler comprised of a living autologous dermal matrix (LADMIX) injectable filler comprising a carrier. 3. The system of claim 2, wherein said injectable filler comprises living fibroblasts. The system of claim 1 , wherein the carrier comprises a fluid, gel, hyaluronic acid, hydrogel, saline, bioactive agent or dermal growth factor. The housing of claim 1 , wherein the housing comprises a vacuum port configured to be coupled to a vacuum source, the vacuum comprises a pressure relatively lower than atmospheric pressure, and wherein the housing is configured to capture the plurality of skin plugs using a vacuum. A system characterized by being. . The system of claim 1 , wherein the plurality of skin plugs are collected in a collection chamber. The system of claim 1 , wherein the end cap includes a fitting configured to couple to a medical device or plug. 8. The system of claim 7, wherein the mincing blade is configured to rotate in response to a force transmitted from the drive system. 9. The system of claim 8, wherein the plurality of skin plugs are minced in the collection chamber. 9. The system of claim 8, wherein mincing comprises rotary mincing, reciprocating mincing, vibratory mincing or compression mogelization. 8. The system of claim 7, wherein the collection chamber is configured to load the composition comprising the skin plug into a syringe or infusion cannula coupled to the fitting. 12. The system of claim 11, wherein a pocket is created in the receptacle for receiving the injectable filler, the pocket being created when the needle is advanced into an area adjacent the receptacle. 12. The method of claim 11, which consists of an aesthetic alteration, a furrow, a wrinkle, a fold, a scarlet skin junction of the upper extremity, a scar, an indented scar, a cosmetic alteration, an area adjacent to the urinary tract or bladder, an area adjacent to the esophageal sphincter, or an area adjacent to the vocal cords. A system comprising a receptacle. The system of claim 1 , wherein the scalpel array is deployed from the housing to the tissue of the donor site, and wherein a plurality of skin plugs are generated at the donor site. The system of claim 1 , wherein the plurality of skin plugs are passively extruded through the plurality of lumens of the plurality of scalpels. The system of claim 1 , wherein the plurality of skin plugs exclude an epidermis. 17. The system of claim 16, wherein the epidermis is removed by exfoliating the epidermis from the dermis. 17. The system of claim 16, wherein the epidermis is removed by the dermis. The system of claim 1 , wherein the plurality of skin plugs are harvested via partial ablation application at the donor site. 20. The system of claim 19, wherein said partial ablation application comprises partial ablation through the dermis. 21. The system of claim 20, wherein partial ablation comprises partial thickness partial ablation through the dermis. 21. The system of claim 20, wherein partial ablation comprises full thickness partial ablation through said dermis. 21. The system of claim 20, wherein the plurality of scalpels are inserted into the donor site and rotated when fully inserted. 2. The system of claim 1, wherein the drive system comprises a gear drive system. 5. The system of claim 1, wherein the drive system comprises a friction drive system configured to generate a friction force through the compressive element of the plurality of scalpels, the friction force configured to rotate the plurality of sets of scalpels. 2. The system of claim 1, wherein the drive system comprises a helical drive system. 2. The system of claim 1, wherein the drive system comprises a slotted drive system comprising a drive rod configured to engage a slotted component of an array of scalpels, wherein the drive rod is configured to move up and down relative to the array of scalpels. A system characterized by being. The system of claim 1 , wherein the scalpel assembly is configured to transmit an axial force to a target area. 5. The system of claim 1, wherein each scalpel of the array of scalpels includes a cylindrical scalpel comprising a cutting surface at a distal end of the scalpel. 30. The system of claim 29, wherein the cutting surface comprises a sharp edge or a serrated edge. 2. The system of claim 1, comprising an electromagnetic system coupled to the scalpel array and configured to couple electromagnetic energy to the scalpel array. delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete delete

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