Pixel array medical devices and methods.

(54) Title: DEVICES AND MEDICAL METHODS OF DISTRIBUTION OF PIXELS.

(54) Title: PIXEL ARRAY MEDICAL DEVICES AND METHODS.

(57) Summary

Systems, instruments or devices, and methods or procedures in which a scalpet arrangement is applied to a target site with the use of a pattern are described. The scalpet arrangement comprises scalpets placed on a device. The skin pixels are inserted into incisions at the target site via the application of a load through the scalpet arrangement. A receptor site is prepared by placing the pattern on the receptor site and applying the scalpet arrangement to generate defective skin. The incised skin pixels are applied to the defective skin at the recipient site.

(57) Abstract

Systems, instruments or devices, and methods or procedures are described in which a scalpet array is applied to a target site with the use of a pattern. The scalpet array comprises scalpets positioned on a device. Skin pixels are incised at the target site via application of a load through the scalpet array. A recipient site is prepared by positioning the pattern at the recipient site and applying the scalpet array to generate skin defects. The incised skin pixels are applied at the skin defects of the recipient site.

PIXEL DISTRIBUTION MEDICAL DEVICES AND METHODS

Field of the Invention

The modalities herein refer to medical systems, instruments or devices, and methods and, more particularly, to medical instrumentation and methods applied to the surgical management of burns, skin defects, and hair transplantation.

Background of the Invention

The aging process is most visibly described by the development of dependent skin sagging. This lifelong process can become evident from the third decade of life and will progressively worsen over the following decades. Histological research has shown that age-related stretching or sagging of the skin is due in part to progressive age-related atrophy associated with reduced skin tensile strength. When combined with the downward force of gravity, age-related dermal atrophy will result in two-dimensional expansion of the skin envelope. The clinical manifestation of this physical-histological process is the redundant sagging of the skin. The most affected areas with the head and neck, upper arms, thighs, breasts, lower abdomen, and knee regions. The

Ref. 265625 Most visible of all areas are the head and neck. In this region, the promising turkey neck sagging of the neck and lower face gills are due to a dependency

<td>non aesthetic of</td><td>the skin on</td><td>these</td><td colspan="2">areas. Frequency and</td>

<td>Social impact</td><td>negative of</td><td>this</td><td>deformity no</td><td>aesthetics has</td>

<td>prompted on</td><td>developing</td><td>of the</td><td>process</td><td>surgical</td>

<td>Stretching</td><td colspan="2">Facial. Others</td><td>procedures</td><td>surgical</td>

Related plastics in different regions are Abdominoplasty (Abdomen), Mastopexy (Breasts), and Brachioplasty (upper part of the Arms).

The inherent adverse features of these surgical procedures are post-operative pain, scarring, and the risk of surgical complications. However, the cosmetic improvement of these procedures is an acceptable compensation for the required significant surgical incisions, extensive permanent scarring is always a titular part of these procedures. For this reason, plastic surgeons design these procedures to hide the extensive scars around anatomical edges such as the capillary line (Facelift), the inframammary folds (Mastopexy), and the inguinal fold (Abdominoplasty). However, many of these incisions are hidden distant from the sagging region of the skin, therefore limiting their effectiveness. Other regions of sagging skin such as the Suprapatellar (frontal-superior) knee are not modifiable for plastic surgical excisions due to poor compensation with a more visible surgical scar. More recently, electromagnetic medical devices that create an inverse thermal gradient (i.e., Thermage) have tried with varying success to tighten the skin without surgery. At this time, these electromagnetic devices are best used in patients with a moderate amount of sagging skin. Due to the limitations of electromagnetic devices and the potential side effects of surgery, minimally invasive technology is necessary to avoid surgically related scars and the clinical variability of electromagnetic skin heating.

Even more significant than the cosmetic modification of the skin envelope is the surgical management of burns and other trauma-related skin defects. Significant burns are classified by the total body surface burned and by the depth of thermal destruction. First-degree and second-degree burns are generally managed in a non-surgical way with the application of topical creams and burn dressings. Deeper third degree burns involve thermal destruction of the full thickness of the skin. Surgical management of these serious injuries involves debridement of the scab from the burn and the application of split thickness grafts. Due to immunological restrictions, permanent split-thickness skin grafts currently require the collection of autologous skin grafts from the same burned patient. Typically, the donor site in the burned patient is selected from an unburned area and a partially thick sheet of skin is collected from that area. What is involved in this procedure is the creation of a partial thickness skin defect at the donor site. Healing by re-epithelialization of the donor site is usually painless and can take several days. In addition, a visible deformity is created at the donor site that is permanently thinner and more depigmented than the surrounding skin. For patients with burns over a significant surface area, extensive collection of skin grafts from unburned areas may also be limited. Thus, there is a need for systems, instruments, or devices, and procedures that eliminate deformity from this donor site and provide the means to repeatedly harvest skin grafts from the same donor site.

INCORPORATION BY REFERENCE

Each patent, patent application, and / or publication referred to in this specification is hereby incorporated by reference in its entirety to the same degree as if each individual patent, patent application, and / or publication is specifically and individually indicated to be incorporated by reference.

Brief Description of the Figures

Figure 1 shows the PAD Kit placed at a target site, under one modality.

Figure 2 is a cross section of a scalpet punch (small circular scalpel) or device including a scalpet arrangement, in one embodiment.

Figure 3 is a partial cross section of a scalpet punch or device including a scalpet arrangement, under one embodiment.

Figure 4 shows the membrane with an adhesive backing (adherent substrate) included in a PAD Kit, under one modality.

Figure 5 shows the adhesive membrane (bonding substrate) when used with the Kit PAD frame and blade assembly, in one embodiment.

Figure 6 shows the removal of the skin pixels, under one modality.

Figure 7 is a side view of the transection of the blade and the removal of pixels from the skin with incisions with the PAD Kit, under one modality.

Figure 8 is an isometric view of the blade / pixel interaction during a procedure using the PAD Kit, under one embodiment.

Figure 9 is another view during a procedure using the PAD Kit (blade removed for clarity) showing both the collected skin pixels or transected and captured connectors and the non-transected skin pixels or connectors prior to transection, under one embodiment. .

Figure 10A is a side view of a pixel distribution portion showing the scalpels secured on an inversion plate, under one embodiment.

Figure 10B is a side view of a pixel distribution portion showing the scalpels secured on an inversion plate, under an alternative embodiment.

Figure 10C is a top view of the scalpet plate, in one embodiment.

Figure 10D is a close-up view of a portion of the scalpet plate, under one embodiment.

Figure 11A shows an example of the rotating pixel drum, under one embodiment.

Figure 11B shows an example of a rotating pixel drum assembled in a handle, under one embodiment.

Figure 11C depicts a Drum Dermatome for use with the scalpet plate, in one embodiment.

Figure 12A shows the drum Dermatome placed on the scalpet plate, under one modality.

Figure 12B is an alternative view of the Drum Dermatome placed on the scalpet plate, under one embodiment.

Figure 13A is an isometric view of the application of the Drum Dermatome (eg, Dermatomo Padgett) on the scalpet plate, where the adhesive membrane is applied to the Dermatome drum before being wound onto the inversion plate, in one embodiment.

Figure 13B is a side view of a portion of the Drum Dermatome showing a position of the blade relative to the scalpet plate, in one embodiment.

Figure 13C is a side view of the drum Dermatome portion showing a different blade position relative to the scalpet plate, under one embodiment.

Figure 13D is a side view of the Drum Dermatome with another position of the blade relative to the scalpet plate, in one embodiment.

Figure 13E is a side view of the Drum Dermatome with the transection blade clip showing the transection of the skin pixels by the blade clip, under one embodiment.

Figure 13F is a bottom view of the Drum Dermatome together with the scalpet plate, in one embodiment.

Figure 13G is a drum Dermatome front view together with the scalpet plate, in one embodiment.

Figure 13H is a rear view of the Drum Dermatome together with the scalpet plate, in one embodiment.

Figure 14A shows an assembled view of the

Dermatome with the Pixel Graft Cover (POS), under one modality.

Figure 14B is an enlarged view of the Dermatome with the Pixel Graft Cover (POS), under one modality.

Figure 14C shows a portion of the Dermatome with the Pixel Graft Cover (POS), under one modality.

Figure 15A shows the sliding PAD that slides on a Padgett Drum Dermatome, under one modality.

Figure 15B shows an assembled view of the sliding PAD installed on the Padgett Drum Dermatome, under one modality.

Figure 16A shows the sliding PAD installed on a Padgett Drum Dermatome and used with a perforated template or guide plate, under one modality.

<td>The</td><td colspan="3">Figure 16B shows the collection of</td><td>pixel</td><td>of</td>

<td>skin with a</td><td>Dermatome</td><td>Padgett Drum and</td><td>the</td><td>Pad</td><td>of</td>

<td>glide</td><td>installed,</td><td>under one modality.</td><td></td><td></td><td></td>

<td>The</td><td>Figure 17A</td><td>shows an example of a</td><td colspan="2">Dermatome</td><td>of</td>

Pixel drum that is being applied to a target site on the skin surface, under one modality.

Figure 17B shows an alternative view of a portion of the Pixel Drum Dermatome being applied to a target site on the skin surface, under one modality.

<td></td><td>The</td><td>Figure</td><td>18A shows a</td><td>view</td><td>top</td><td>a</td>

<td>arrangement</td><td>of</td><td>scalpet</td><td>oscillatory plane</td><td>and the</td><td>device</td><td>of</td>

<td>knife</td><td colspan="3">, under a modality.</td><td></td><td></td><td></td>

<td></td><td>The</td><td>Figure</td><td>18B shows a</td><td>view</td><td>lower than</td><td>a</td>

<td>arrangement</td><td>of</td><td>scalpet</td><td>oscillatory plane</td><td>and the</td><td>device</td><td>of</td>

blade, under one modality.

Figure 18C is an approximation view of the flat array, when the array of scalpels, blades, adherent membrane, and adhesive backing are assembled together, in one embodiment.

Figure 18D is an approximation view of the flat arrangement of scalpels with a feeder component, under one embodiment.

Figure 19 shows a cylindrically transected cadaveric dermal matrix similar in size to the collected skin pixel grafts, under one modality.

Figure 20 is a drum set drug delivery device, in one embodiment.

FIG. 21A is a side view of a needle fixation drug delivery device, in one embodiment.

Figure 21B is a top isometric view of a needle fix drug delivery device, under one embodiment.

Figure 21C is a bottom isometric view of a needle fix drug delivery device, under one embodiment.

Figure 22 shows the collection of donor follicles, under one modality.

Figure 23 shows the preparation of the receptor site, under one modality.

Figure 24 shows the placement of the harvested hair connectors at the receptor site, under one modality.

Detailed description of the invention

Pixel delivery systems, instruments or devices, and medical methods are described for hair removal, skin grafting procedures, and hair transplantation procedures. In the following description, numerous specific details are introduced to provide a thorough understanding of, and enable the description for, the embodiments herein. A person skilled in the relevant art, however, will recognize that these modalities can be practiced without one or more of the specific details, or with other components, systems, etc. In other instances, well-known structures or operations are not shown, or described in detail, to avoid obscuring aspects of the described modalities.

The following terms are intended to have the following general meaning as may be used herein. The terms however are not limited to the meanings stated herein as the meanings of any term may include other meanings as understood or applied by one skilled in the art.

First degree burn as used herein, includes a superficial thermal injury where there is no alteration of the epidermis of the dermis. A first degree burn is visualized as erythema (redness) of the skin.

Second degree burn, as used herein, includes a relatively deep burn where there is an alteration of the epidermis of the dermis and where the varying thickness of the dermis is also denatured. Most second degree burns are associated with blistering. Deep second-degree burns can develop into full-thickness third-degree burns, usually from oxidation or infection.

Third degree burn, as used herein, includes a burn associated with thermal destruction of the full thickness of the skin including the epidermis and dermis. A third degree burn may also be associated with thermal destruction of the underlying, deeper tissues (subcutaneous and muscle layers).

Ablation, as used herein, includes removal of tissue by destruction of tissue, eg, thermal ablation of a skin lesion by a laser.

Autograft, as used herein, includes a graft taken from the same patient.

Adherent Backing Membrane, as used herein, includes the elastic adherent membrane that captures transected skin trimmings. One-way Backing Adherent Membrane is placed as a backing on the outer surface to retain the alignment of skin cuts during collection. After the collection of skin trimmings, the backing is removed from the adherent membrane with collected skin trimmings. The membrane of one embodiment is porous to allow drainage when placed at the receptor site. The membrane of one embodiment also possesses an elastic rewinding property such that when the backing is removed, it brings the skin trim sides closer to each other to promote healing at the receptor site such as a sheet graft.

Burn scar contraction, as used herein, includes stretching the scar tissue that occurs during the wound healing process. This process is more likely to occur with an untreated third degree burn.

Burn scar contracture, as used herein, includes a band of scar tissue that either limits the range of motion of a joint or band of scar tissue that distorts the patient's appearance, i.e., a scar contracture Of the face.

Dermatome, as used herein, includes an instrument that cuts the skin or collects a split-thickness skin graft sheet. Examples of drum dermatomes include the Padgett and Reese dermatomes. The electrically activated dermatomes are the Zimmer Dermatome and an electrical version of the Padgett Dermatome.

Dermis, as used herein, includes the deep layer of the skin that is the primary support and primarily comprises non-cellular collagen fibers. Fibroblasts are cells in the dermis that make collagen protein fibers.

Donor Site, as used herein, includes the anatomical site from which a skin graft is collected.

Epidermis, as used herein, includes the outer layer of the skin comprising viable epidermal cells and the non-viable stratum corneum that acts as a biological barrier.

Extirpar, as used herein, includes surgical removal of tissue.

Excision Skin Defect, as used herein, includes a partial thickness or, more typically full thickness defect resulting from surgical removal (excision / resection) of the skin (injury).

FTSG, as used herein, includes a Full Thickness Skin Graft where the full thickness of the skin is collected. With the exception of an instrument as described herein, the donor site is closed as a surgical incision. For this reason, FTSG is limited in the surface area that can be collected.

Fibrous Tissue, as used herein, includes highly vascularized tissue that grows in response to the absence of skin in a full-thickness skin defect. Fibrous Tissue is the ideal base for the skin graft receptor site.

First-attempt healing, as used herein, includes the wound healing process in which normal structures are realigned with minimal scar tissue formation. Morphologically, the scar is less likely to be visible.

Second-attempt healing, as used herein, includes an organized wound healing process where healing occurs with less alignment of anatomical structures and with increased deposition of the scarred collagen. Morphologically, the scar is more likely to be visible.

Homograft, as used herein, includes a graft taken from a different human and applied as a temporary biological dressing at the recipient site in a patient. Most homografts are collected as corpse skin. A temporary take of a homograft can be partially obtained with immunosuppression, but homografts are eventually replaced by autografts if the patient survives.

Making an incision, as used herein, includes making a surgical incision without tissue removal.

Meshed Split Thickness Skin Graft, as used herein, includes a split thickness skin graft that expands in its surface area by repeated incisions in the skin graft collected with an instrument called a crosslinker. A split thickness reticulated skin graft has a higher intake percentage than a sheet graft because it allows drainage through the graft and better conforms to the contour irregularities of the recipient site. However, it does result in an unsightly cross-linked appearance of the graft at the recipient site.

PAD, as used herein, includes a

Pixel Distribution Dermatome, the class of instruments for fractional skin resection.

PAD Kit, as used herein, includes the disposable single-use procedure kit comprising the perforated guide plate, scalpet stamper, guide plate frame, adhesive backing membrane, and transect knife.

Perforated Guide Plate, as used herein, includes a perforated plate that comprises the entire graft harvesting area where the holes in the guide plate align with the scalpets of the manipulated stamper or sliding PAD. The plate will also function as a protector to prevent inadvertent laceration of the adjacent skin. Guide Plate perforations can be of different geometries such as, but not limited to, round, oval, square, rectangular, and / or triangular.

Pixelated Full Thickness Skin Graft, as used herein, includes a Full Thickness Skin Graft that has been collected with an instrument as described herein, with no apparent scarring visibly reduced at the donor site. The graft will also have an improved appearance at the foil FTSG-like receptor site, but will better shape the receptor site and will have a higher 'tap' percentage due to drain gaps between connectors. Another significant advantage of the FTSG compared to a foil FTSG is the ability to graft larger surface areas that would otherwise require an STSG. This advantage is due to the ability to collect from multiple donor sites with reduced visible scarring.

Pixelated Graft Collection, as used herein, includes the skin graft collected from the donor site by an instrument as described in detail herein.

Pixelated Split Thickness Skin Graft, as used herein, includes a partial thickness skin graft that has been collected with an SRG instrument. The skin graft shares the benefits of an unsightly meshed skin graft without donor and recipient sites.

Receiver Site, as used herein,

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<td>inj erto</td><td>fur</td><td></td><td></td><td></td><td></td>

<td></td><td>Remove,</td><td>how I know</td><td>uses</td><td>in</td><td>this includes</td>

<td colspan="2">cleavage.</td><td></td><td></td><td></td><td></td>

<td></td><td>Scalpel</td><td>how I know</td><td>uses</td><td>in</td><td>this includes</td>

the single-edged blade that makes incisions in skin and soft tissue.

Scalpet as used herein includes the term that describes the small circular scalpel (or other geometric shape) that makes incisions in a skin cutout.

Scalpet arrangement, as used herein, includes the arrangement or arrangement of multiple scalpets secured to either a motherboard or a tampered stamper.

Scalpet Stamper, as used herein, includes a manipulated scalpet fixation instrument component of the PAD Kit that makes incisions in the skin cutouts through the perforated guide plate.

Scarring, as used herein, includes the histological deposition of disorganized collagen after healing, and the morphological deformity that is visually evident.

Full Thickness Skin Graft, as used herein, includes reference to the application of FTSG at the receptor site as a full sheet. The appearance of an FTSG is superior to the appearance of an STSG and for this reason it is primarily used to graft skin into visually obvious areas such as the face.

Lamina Split Thickness Skin Graft, as used herein, includes a partial thickness skin graft that is a continuous sheet and is associated with deformity of the typical donor site.

Skin defect, as used herein, includes the absence of the full thickness of the skin which may also include the subcutaneous fatty layer and deeper structures such as muscles. Skin defects can occur from a variety of causes, i.e. burns, trauma, surgical removal of malignancies, and correction of congenital deformities.

Skin Pixel, as used herein, includes the Skin Trim.

Skin Trimming as used herein, includes a circular (or other geometric shape) skin insert comprising the epidermis and a partial or full thickness of the dermis that is cut with the scalpet, transected by the blade, and captured by the membrane with adherent backing.

STSG, as used herein, includes the Partial Thickness Skin Graft where the epidermis and a portion of the dermis are collected with the graft.

Subcutaneous Fat Layer, as used herein, includes the layer just below the skin and is primarily comprised of fat cells referred to as lipocytes. This layer works as the main insulating layer of the environment.

Transection Knife, as used herein, includes a horizontally aligned single edge knife that can be either grooved into the frame of the perforated plate or coupled to the stabilizer arm of the Drum Dermatome as described in detail herein . The transection blade transects the base of incised skin inserts.

Healing, as used herein, includes the mandatory biological process that occurs from any type of wound, be it thermal, kinetic, or surgical.

Xenograft, as used herein, includes a graft taken from a different species and applied as a temporary biological bandage to a recipient site in a patient.

Multiple modalities of medical pixel distribution systems, instruments or devices, methods of use are described in detail herein. The systems, instruments or devices, and methods described herein comprise minimally invasive surgical methods for skin grafting and for skin resection that stretches loose skin without visible scarring via a device used in various surgical procedures such as plastic surgical procedures, and additionally for hair transplantation. In some embodiments, the device is a disposable, single-use instrument. The modalities herein avoid surgically related healing and the clinical variability of electromagnetic skin heating and perform multiple small pixelated skin resections as a minimally invasive alternative to large plastic surgical skin resections. The modalities herein can also be used in hair transplantation, and in areas of the body that may be outside the limits of plastic surgery due to the visibility of the surgical scar. Furthermore, the method can carry out the skin grafting operation by collecting transected skin incisions from a donor tissue site onto a recipient skin defect site with reduced scarring from the patient donor site.

For many patients who have sagging age-related skin (for non-limiting examples, neck and face, arms, armpits, thighs, knees, buttocks, abdomen, bra line, sagging breasts, etc.), the medical devices of Minimally invasive pixel distribution and methods herein perform pixelated transection / resection of excess skin, replacing plastic surgery with its involved scarring. Generally, the procedures described herein are performed in an office under local anesthesia with minimal, but not limited, perioperative discomfort. Compared to a prolonged healing phase of plastic surgery, only a short recovery period is required, preferably applying a bandage and wearing a support garment over the treatment area for a predetermined period of time (for example, 5 days , 7 days, etc.). There will be minimal, if any, pain associated with the procedure.

Relatively small skin defects (eg, in a range of about 0.5mm to 4.0mm) generated by the instrumentation described herein are closed with the application of a Flexan® adhesive sheet. Working as a large butterfly bandage, the Flexan® sheet can be pulled in one direction (vector) that maximizes the aesthetic contour of the treatment area. A compressive elastic garment is applied on the bandage to also help the aesthetic contour. After the initial healing phase is complete, the multiplicity of small linear scars within the treatment area will have reduced visibility compared to larger plastic surgical incisions in the same area. Additional skin tightening is likely to occur for several months due to the delayed healing response. Other potential applications of the modalities described herein include hair transplantation, as well as treatment of Alopecia, Snoring / Sleep Apnea, Orthopedic Physiatry, Vaginal Stretching, Female Urinary Incontinence, and stretching of the gastrointestinal sphincters.

Significant burns are classified by the total body surface burned and by the depth of thermal destruction, and the methods used to manage these burns are highly dependent on classification. First-degree and second-degree burns are usually managed in a non-surgical way with the application of topical creams and burn bandages. Deeper third-degree burns involve thermal destruction of the full thickness of the skin, creating a full thickness skin defect. Surgical management of these serious injuries usually involves debridement of the burned scab and the application of split thickness grafts.

A full-thickness skin defect, most often created from burns, trauma, or resection of a skin malignancy, can be closed with either skin flap transfers or skin grafts using conventional commercial instrumentation. Both surgical methods require collection from a donor site. The use of a skin flap is further limited by the need to include a pedicle blood supply and in most cases by the need to directly close the donor site.

The split thickness skin graft procedure, due to immunological restrictions, requires collecting autologous skin grafts from the same patient. Typically, the donor site in the burned patient is selected from an unburned area and a sheet of partial thickness skin is collected from that area. Something relevant in this procedure about the burned patient is selected in an unburned area and a sheet of partial thickness skin is collected from that area. Relevant in this procedure is the creation of a partial thickness skin defect at the donor site. This donor site defect by itself is similar to a deep second degree burn. Reepithelial healing of this site is often painful and can last for several days. Furthermore, a visible deformity of the donor site is typically created, which is permanently thinner and more depigmented than the surrounding skin. For patients who have burns over a significant surface area, the extensive collection of skin grafts will also be limited by the availability of unburned areas.

Both conventional surgical methods of closing skin defects (flap transfer and skin graft) are not only associated with significant scarring of the skin defect receptor site but also with the donor site from which the graft is collected. In contrast, for conventional procedures, the modalities described herein comprise Pixelated Skin Graft Procedures, also referred to as pixel distribution procedures, which remove deformity from this donor site and provide a method of re-harvesting skin grafts from any pre-existing donor site including any foil or pixelated donor site. This ability to re-harvest skin grafts from pre-existing donor sites will reduce the skin surface area requirement of the donor site and provide the ability to graft additional skin in severely burned patients with limited surface area of ​​donor skin without burns.

The One-Mode Pixelated Skin Graft Procedure is used as a full-thickness skin graft. Many clinical applications such as facial skin grafting, hand surgery, and congenital deformity repair are best performed with full-thickness skin grafts. The texture, pigmentation, and overall morphology of a full-thickness skin graft more closely resembles the skin adjacent to a defect than a split-thickness skin graft. For this reason,

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<img file="MX2016004331A_D0002.tif" />

erto

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skin

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areas is superior in appearance than those visibly apparent

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inconvenience full thickness main skin grafts under procedures

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extensive linear scarring created from surgical closure of the full-thickness donor site defect; This scarring limits the size and usefulness of the full-thickness skin graft.

In comparison, the full thickness skin graft from the Pixelated Skin Graft Procedure described herein is less limited by the size and utility of the linear donor site scar is removed. In this way, many skin defects routinely covered with split-thickness skin grafts will rather be treated using pixelated full-thickness skin grafts.

The Pixelated Skin Graft Procedure provides the ability to collect split-thickness, full-thickness skin grafts with minimal visible scarring from the donor site. During the procedure, a device, Pixel Distribution Dermatome (PAD), is used to collect skin grafts from a selected donor site. During the harvesting process, the pixelated skin graft is deposited on an adherent membrane. The adherent membrane of one embodiment includes a flexible, semi-porous adherent membrane, but the embodiment is not thus limited. The collected skin graft / membrane composition is then applied directly to the defective recipient skin site. The fractionally excised donor site is closed with the application of an adherent Flexan® laminate that works for a week as a large butterfly bandage. Relatively small intradermal circular skin defects (eg 1.5 mm) are closed to promote a primary healing process in which the normal epidermal-dermal architecture is realigned in an anatomical way to minimize scarring. It also occurs approximately one week after the operation that the adherent membrane is peeled off (removed) with the stratum corneum of the graft; the membrane can then be removed without disturbing the graft from the recipient bed. In this way, healing of the donor site occurs rapidly with minimal discomfort and scarring.

Because grafting skin at the recipient's defective site using the Pixelated Skin Grafting Procedure pixelates, it provides empty spaces for drainage between the skin's pixel components, which improves the percentage of grafts, compared to grafts made of reed skin. During the first postoperative (approximate) week, the skin graft will take at the recipient site through the neovascularization process in which new vessels grow from the receptor bed of the defective skin growth new skin grafts. The semi-porous membrane will conduct the transudate (fluid) in the dressing. Furthermore, the flexible membrane is designed with an elastic rewind property that promotes the apposition of the component skin pixels within the graft / membrane compound and promotes the primary adjacent healing of the skin graft pixels, converting the pixelated appearance of the skin graft in a uniform sheet morphology. Additionally, the membrane is aligned with the epidermis and the dermis is aligned with the dermis, promoting a primary healing process that reduces scarring. Furthermore, pixelated skin grafts more easily form an irregular receptor site.

The modalities described herein also include a Pixelated Skin Removal Procedure, also referred to herein as the Pixel Procedure.

For many patients who have sagging, age-related skin (neck and face, arms, armpits, thighs, knees, buttocks, abdomen, breast line, sagging breasts, etc.), the fractional removal of excess skin may replace a significant segment of plastic surgery with its dominant scarring. Generally, the Pixel Procedure will be performed in an office under local anesthesia. The post-procedure recovery period includes wearing a support garment over the treatment area for a predetermined number of (eg, five, seven, etc.) days (eg, five days, seven days, etc.). Relatively little or no pain associated with the procedure is anticipated. Small circular skin defects will be closed with the application of a Flexan® adhesive film. Functioning as a large butterfly bandage, the Flexan® sheet is pushed and pulled in a direction (vector) that maximizes the aesthetic contour of the treatment area. Then a compressive elastic garment is applied on the bandage to also help in the aesthetic contour. After completion of the initial healing phase, the multiplicity of small linear scars within the treatment area will not be visibly apparent. Also, additional skin tightening will subsequently occur for several months due to the delayed wound healing response. Consequently, the Pixel Procedure is a minimally invasive alternative for the extensive scarring of Plastic Surgery.

Pixel distribution medical devices of one embodiment include a PAD Kit. Figure 1 shows the PAD Kit placed at a target site, under one modality. The PAD Kit comprises a flat perforated guide plate (guide plate), a scalpet punch or device that includes a scalpet arrangement (Figures 1-3), an adhesive backed membrane or adherent substrate (Figure 4), and a cutting blade. skin pixel transection (Figure 5), but is not thus limited. The modality scalpet punch is a portable device but is not limited to this. The guide plate is optional in an alternative embodiment, as described in detail herein.

Figure 2 is a cross section of a PAD Kit scalpet punch including a scalpet arrangement, under one embodiment. The scalpet arrangement includes one or more scalpet. Figure 3 is a partial cross section of a Kit PAD scalpet punch including a scalpet arrangement, under one embodiment. The partial cross section showing the total length of the scalpets of the scalpet arrangement is determined by the thickness of the perforated guide plate and the depth of the incisions within the skin, but the modality is not limited to this.

Figure 4 shows the membrane with an adhesive backing (adherent substrate) included in a PAD Kit, under one modality. The underside of the adhesive membrane is applied to the skin with incisions at the target site.

Figure 5 shows the adhesive membrane (bonding substrate) when used with the Kit PAD frame and blade assembly, in one embodiment. The top surface of the adhesive membrane faces the adhesive side down into the frame and is then pressed onto the perforated plate to capture the pixels of the extruded skin, also referred to herein as skin pieces or inserts.

Referring to Figure 1, the perforated guide plate is applied to the skin donor / removal site during a procedure using the PAD Kit. The scalpet punch is applied through at least one set of perforations in the perforated guide plate to make incisions in the pixels of the skin. The scalpet punch is applied numerous times to a number of groups of perforations when the punch scalpet arrangement includes fewer scalpets than the total number of guide plate perforations. After one or more serial applications with the scalpet punch, the pixels or incised skin inserts are captured on the adherent substrate. The adherent substrate is then applied in such a way that the adhesive captures the extruded pixels or leather inserts. As an example, the top surface of the adhesive substrate of one embodiment is oriented with the adhesive side down into the frame (when using the frame) and then pressed onto the perforated plate to capture the pixels or extrudate pieces. As the membrane is pulled upward, the captured skin pixels are transected at their base by the transection blade.

Figure 6 shows the removal of the skin pixels, under one modality. The adherent substrate is pulled up and back (away) from the target site, and this action raises or pulls the pixels or incised skin inserts. Since the adherent substrate is being pulled upward, the transection blade is used to transect the bases of the incised skin pixels. Figure 7 is a side view of the transection of the blade and the removal of pixels from the skin with incisions with the PAD Kit, under one modality. The collection of the pixels is completed with the transection of the base of the pixels or leather inserts. Figure 8 is an isometric view of the blade / pixel interaction during a procedure using the PAD Kit, under one embodiment. Figure 9 is another view during a procedure using the PAD Kit (blade removed for clarity) showing both collected and captured pixels or skin inserts and the non-transected pixels or skin inserts prior to transection, under one embodiment. At the donor site, pixelated skin removal sites are closed with the application of a Flexan® laminate.

The guide plate and scalpet device are also used to generate skin defects at the receptor site. Skin defects are configured to be received at the collected skin pixels or captured at the donor site. The guide plate used at the recipient site may be the same guide plate used at the donor site, or it may be different with a different pattern or pattern of perforations.

Pixels or skin inserts deposited on the adherent substrate during transection can then be transferred to the site with defective skin (receptor site) where they are applied as a pixelated skin graft at the recipient site with defective skin. The adherent substrate has an elastic rewinding property that allows the closest alignment of the pixels or skin inserts within the skin graft. The incised skin pixels can be applied from the adherent substrate directly to the defective skin at the receptor site. Application of the incised skin pixels at the recipient site includes aligning the incised skin pixels with the defective skin, and insertion of the corresponding defective skin incised skin pixels at the recipient site.

The medical pixel distribution devices of one modality include a

Pixels (PAD). The PAD comprises the flat distribution of relatively small circular scalpets that are secured on a substrate (eg, inversion plate), and the scalpets in combination with the substrate are referred to herein as a scalpet arrangement, pixel distribution, or scalpet plate. Figure 10A is a side view of a pixel distribution portion showing the scalpets secured on an inversion plate, under one embodiment. Figure 10B is a side view of a pixel distribution portion showing the scalpets secured on an inversion plate, under an alternative embodiment. Figure 10C is a top view of the scalpet plate, in one embodiment.

Figure 10D is a close-up view of a portion of the scalpet plate, under one embodiment. The scalpet plate is applied directly to the surface of the skin. One or more scalpets in the scalpet arrangement include one or more pointed surfaces, a needle, and a needle including multiple points.

Pixel distribution medical device modalities and methods include the use of a collection pattern instead of the guide plate. The collection pattern comprises indicators or markers on a skin surface in at least one of the donor site and the recipient site, but is not limited to this. Markers include any compound that can be applied directly to the skin to mark an area of ​​the skin. The collection pattern is placed at a donor site, and the device scalpet arrangement is aligned with or according to the collection pattern at the donor site. The pixels of the skin are incised at the donor site with the scalpet arrangement as described herein. The recipient site is prepared by placing the collection pattern at the recipient site. The collection pattern used at the recipient site may be the same collection pattern used at the donor site, or it may be different with a different pattern or marker configuration. Defective skin is generated, and incised skin pixels are applied at the receptor site as described herein. Alternatively, the guide plate of one embodiment is used in applying the harvesting pattern, but the embodiment is not limited thereto.

To take advantage of established surgical instrumentation, a modal arrangement is used in conjunction with, or as a modification of, but is not limited to, a Drum Dermatome, eg, a Dermatome Padget or a Dermatome Reese. The Padget Drum Dermatome referenced herein was originally developed by Dr. Earl Padget in the early 1930s, and continues to be widely used for skin grafting by plastic surgeons around the world. The Reese modification of the Padget dermatome was subsequently developed to better calibrate the thickness of the collected skin graft. The Drum Dermatome of one modality is disposable for single use (per procedure), but is not limited to this.

Generally, Figure 11A shows an example of a rotating pixel drum 100, under one embodiment. Figure 11B shows an example of a rotating pixel drum 100 assembled in a lug, under one embodiment. More specifically, Figure 11C depicts a Drum Dermatome for use with the scalpet plate, in one embodiment.

Generally, as with all the pixel devices described herein, the geometry of the pixel drum 100 can have a variety of shapes without limitation, for example, circular, semi-circular, elliptical, square, flat, or rectangular. In some embodiments, the pixel drum 100 is supported by a shaft / handle assembly 102 and rotates around a rotational drum component 104 activated by, for example, an electric motor. In some embodiments, pixel drum 100 can be placed on a bracket (not shown) when not in use, where the bracket can also function as a battery recharger for the rotationally activated component of the drum or the activated component of the plunger of the drum. syringe. In some embodiments, a vacuum (not shown) can be applied to the skin surface of pixel drum 100 and stabilizers (not shown) can be deployed for tracking and stability of the pixel drum

100 .

In some embodiments, pixel drum 100 incorporates an array of scalpets 106 on the surface of drum 100 to create multiple small circular incisions (eg, 0.5-1.5 mm) referred to herein as skin inserts. In some embodiments, the edge geometries of the scalpets can be designed to reduce bolt damping (hatch) while creating the leather inserts. The perimeter of each leather insert can also be lengthened by the scalpets for, for a non-limiting example, a semi-circular, elliptical, or square-shaped leather insert of a circular leather insert. In some embodiments, the length of the scalpets 106 can vary depending on the area of ​​skin selected by the surgeon for skin grafting purposes, i.e., partial thickness or full thickness.

When drum 100 is applied to the skin surface, a knife 108 placed internally in drum 100 transects the base of each skin insert created by the scalpet arrangement, where the internal knife 108 connects to the shaft assembly / center drum handle 102 and / or connected to stabilizers attached to center shaft assembly 102. In some alternative embodiments, the inner blade 108 is not connected to the drum shaft assembly 102 where the base of the skin incisions are transected. In some embodiments, the inner blade 108 of the pixel drum 100 can oscillate either manually or driven by an electric motor. Depending on the density of the circular scalpets in the drum, a varying percentage of skin (for example, 20%, 30%, 40%, etc.) can be transected into an area of ​​excess flaccid skin.

In some embodiments, an additional pixel drum picker 112 is placed within the perform drum skin graft 100 operation by collecting and aligning the transected / pixelated (graft) skin incisions / inserts from the tissue of a pixel donor on an adherent membrane 110 lined inside the pixel drum 100. A narrower gap is created between the array of scalpets 106 and the adherent membrane 110 for the inner blade 108.

In one embodiment, blade 108 is positioned external to drum 100 and scalpet arrangement 106 where the base of the circular incised skin pieces are transected. In another embodiment, the outer blade 108 is connected to the drum shaft assembly 102 when the base of the skin incisions is transected. In an alternative embodiment, the outer blade 108 is not connected to the drum shaft assembly 102 when the base of the skin incisions is transected. The adherent membrane 110 that removes and aligns the subsequently transected skin segments is placed over a site with defective skin from a patient. Blade 108 (either internal or external) may be a fenestrated layer of the blade aligned with scalpet arrangement 106, but is not limited thereto.

The conformable adherent membrane 110 of one embodiment may be semi-porous to allow drainage into a defective recipient skin when the membrane with the aligned transected skin segments is removed from the drum and applied as a skin graft. The adherent semi-porous drum membrane 110 may also have an elastic rewinding property to bring the transected / pixelated skin graft inserts together at the site with defective skin from the recipient, i.e. the margins of each skin insert may be brought together as one more uniform sheet after adherent membrane with pixelated grafts drum 100 is removed. Alternatively, the adherent semi-porous drum membrane 110 may be expandable to cover a large surface area of ​​the site with defective skin of the receptor. In some embodiments, an adhesive backed sheet 111 can be applied between the adherent membrane 110 and the drum collector 112. The scalpet arrangement of drum 106, blade 108, and adherent membrane 110 can be assembled together as a sleeve on a pre-existing drum 100, as described in detail herein.

The internal drum collector 112 of the pixel drum 110 of one embodiment is disposable and replaceable. Limiting and / or controlling the use of disposable components can be accomplished by means including, but not limited to, electronic, EPROM, mechanical, durability. Electronic and / or mechanical records and / or limits on the number of drum rotations for the disposable drum, as well as the usage time of the disposable drum can be recorded, controlled and / or limited either electronically or mechanically.

During the harvest portion of the Drum Dermatome procedure, the PAD arrangement of the scalpet is applied directly to the surface of the skin. To make circumferential incisions in the pixels of the skin, the Drum Dermatome is placed on a scalpet arrangement to apply a load on the surface of the underlying skin. With continuous loading, the incised skin pixels are extruded through the holes in the scalpet array and captured in an adherent membrane on the Drum Dermatome. The Dermatome Cut Stabilizer Blade (placed on a scalpet arrangement) transects the base of the extruded skin pixels. The membrane and pixelated skin composition are then removed from the dermatome drum, to be applied directly to the recipient defective skin as a skin graft.

Referring to Figure 11C, one embodiment includes a Drum Dermatome for use with the scalpet plate, as described herein. More particularly, Figure 12A shows the Drum Dermatome placed on the scalpet plate, under one embodiment. Figure 12B is an alternative view of the Drum Dermatome placed on the scalpet plate, under one embodiment. The Drum Dermatome Cut Stabilizer Blade is placed on top of the scalpet arrangement where the extruded leather inserts will be transected at its base.

Figure 13A is an isometric view of the application of the Drum Dermatome (eg, Dermatomo Padgett) on the scalpet plate, where the adhesive membrane is applied to the Dermatome drum before being wound onto the inversion plate, in one embodiment. Figure 13B is a side view of a portion of the Drum Dermatome showing a blade positioned relative to the scalpet plate, under one embodiment. Figure 13C is a side view of the drum Dermatome portion showing a different position of the blade relative to the scalpet plate, under one embodiment. Figure 13D is a side view of the Drum Dermatome with another position of the blade relative to the scalpet plate, in one embodiment. Figure 13E is a side view of the Drum Dermatome with the transection blade clip showing the transection of the skin pixels by the blade clip, under one embodiment. Figure 13F is a bottom view of the Drum Dermatome together with the scalpet plate, in one embodiment. Figure 13G is a front view of the Drum Dermatome together with the scalpet plate, in one embodiment. Figure 13H is a rear view of the Drum Dermatome together with the scalpet plate, in one embodiment.

Depending on the clinical application, the Drum Dermatome Disposable Adherent Membrane can be used to deposit / remove excised loose skin or collect / align a pixelated skin graft.

The modalities described herein also include a Pixel Graft Sleeve (POS) for use with Dermatomes, eg, Padgett Dermatomes and Reese Dermatomes.

Figure 14A shows an assembled view of the Dermatome with the Pixel Graft Cover (POS), under one modality. The POS comprises the built-in dermatome and blade with an adhesive backing, adhesive, and a scalpet arrangement. The adhesive backing, the adhesive and the arrangement of the

<td>scalpet</td><td>is it so</td><td>integrated</td><td>in</td><td>the device but not</td><td>they are like this</td>

<td colspan="2">limited.</td><td></td><td></td><td></td><td></td>

<td></td><td>The</td><td>Figure 14B</td><td>is</td><td>an enlarged view of</td><td>Dermatome</td>

<td>with the</td><td>Sheath</td><td>Graft</td><td>of</td><td>Pixel (POS), under a</td><td>modality.</td>

Figure 14C shows a portion of the Dermatome with the Pixel Graft Cover (POS), under one modality.

The POS, also referred to herein as the sheath, provides an overlay disposable drum dermatome for fractional removal of redundant loose skin and fractional skin grafting of defective skin. The overlay sleeve is used in conjunction with any Padgett and Reese dermatomes as a single-use disposable component. A modal's POS is a three-sided sliding disposable sleeve that slides over a drum Dermatome. The device comprises an adherent membrane and a scalpet drum arrangement with an internal transection blade. The transection blade of one embodiment includes a single-sided cutting surface that is swept across the inner surface of the scalpet drum arrangement.

In an alternative blade modality, a fenestrated cutting layer covers the inner surface of the scalpet arrangement. Each fenestration with its cutting surface is aligned with each individual scalpet. Instead of the sweeping motion to transect the base of the skin inserts, the fenestrated cutting layer oscillates over the scalpet drum arrangement. A narrow gap is created between the adherent membrane and the scalpet arrangement for blade excursion. For multiple harvests during a skin graft procedure, an insertion slot is provided for additional adherent membranes. The protective layer over the adherent membrane is peeled in place with an elongated pull tab that is pulled from a pull groove on the opposite side of the sleeve assembly. As with other modalities of the pixel device, the adherent membrane is semi-porous for drainage at the receptor site with defective skin. To transform the pixelated skin graft into a more continuous sheet, the membrane may also have an elastic rewind property to provide closer alignment of the skin inserts within the skin graft.

The modalities described herein include a sliding PAD that is configured as a single-use disposable device with any Padgett or Reese dermatome. Figure 15A shows the sliding PAD that slides on a Padgett Drum Dermatome, under a

<td>modality. The</td><td colspan="4">Figure 15B shows an assembled view of the PAD</td>

<td colspan="2">Sliding</td><td>installed on</td><td>the Dermatome of</td><td>Drum</td>

<td>Padgett, bass</td><td>a</td><td>modality.</td><td></td><td></td>

<td>The</td><td>Pad</td><td>sliding</td><td>a modality</td><td>it's used</td>

(optionally) in combination with a perforated guide plate. Figure 16A shows the sliding PAD installed on a Padgett Drum Dermatome and used with a perforated template or guide plate, under one modality. The perforated guide plate is placed over the target skin site and is held in place with adhesive on the underside of the platform to maintain orientation. The Padgett dermatome with the sliding PAD is wound on the perforated guide plate on the skin.

Figure 16B shows the collection of skin pixels with a Padgett Drum Dermatome and sliding PAD installed, under one modality. For collecting skin pixels, the slip PAD is removed, tape is applied to the drum of the Dermatomo Padgett, and the clamped blade is installed on the Dermatomo stabilizer arm, which is then used to transect the base of the the pixels of the skin. The one-way sliding PAD is also (optionally) used with standard surgical instrumentation such as a slat retractor to protect the adjacent skin from the donor site.

The modalities of the pixel instruments described herein include a Pixel Drum Dermatome (PD2) which is a disposable instrument or disposable device. The PD2 comprises a rotary / rotary cylinder or drum attached to a handle, and the cylinder includes a Scalpel Drum Arrangement. An internal blade interfaces with the drum axle / handle assembly and / or interfaces with stabilizers attached to the center axle. As with the PAD and POS described herein, multiple small pixelated skin resections are performed directly in the flaccid skin region, thereby improving skin tightening with minimal visible scarring.

Figure 17A shows an example of a

Pixel drum that is being applied to a target site on the skin surface, under one modality. Figure 17B shows an alternative view of a portion of the Pixel Drum Dermatome being applied to a target site on the skin surface, under one modality.

The PD2 device applies a complete rotary / rotary drum to the skin surface where multiple small incisions are created (for example, from

1.5 mm) circular at the target site with a Scalpet Drum Array. The base of each skin insert is then transected with an internal blade that interfaces with the center drum shaft / gripper assembly and / or interfaces with stabilizers attached to the center shaft. Depending on the density of the circular scalpets in the drum, a variable percentage of skin can be removed. PD2 allows portions (eg, 20%, 30%, 40%, etc.) of the skin's surface area to be removed without visible scarring in an area of ​​excessive flaccid skin, but the modality is not limited to this.

Another alternative embodiment of the pixel instruments presented herein is the Pixel Drum Collector (PDH). Similar to the Pixel Drum Dermatome, an added internal drum collects and lines up pixelated skin resections on an adherent membrane that is then placed over a recipient site with the patient's faulty skin. The conformable adherent membrane is semi-porous to allow drainage into the recipient defective skin when the membrane in the excised skin segments is removed from the drum and applied as a skin graft. An elastic membrane rewinding property allows a closer approximation of the pixelated skin segments, partially converting the pixelated skin graft to a foil graft at the receptor site.

The medical pixel distribution systems, instruments or devices, and the methods described herein evoke or enable cellular and / or extracellular responses that are mandatory for the clinical results to be obtained. For pixel dermatomes, a physical reduction of the skin surface area occurs due to pixelated removal of the skin, i.e. the creation of the skin inserts. In addition, a subsequent stretching of the skin results due to the delayed wound healing response. Each pixelated excision initiates a mandatory multistage wound healing sequence, as described in detail herein.

The first phase of this sequence is the inflammatory phase in which degranulation of mast cells releases histamine into the wound. The released histamine can evoke the dilation of the capillary bed and increase the permeability of the vessels in the extracellular space. This initial wound healing response occurs within the first day and will be evident as erythema on the skin surface.

The second phase (of Fibroplasia) begins within three to four days of the laceration. During this phase, there is the migration and mitotic multiplication of fibroblasts. Fibroplasia of the wound includes the deposition of neo-collagen and myofibroblastic contraction of the wound.

Histologically, the deposition of neocollagen can be identified microscopically as compaction and thickening of the dermis. Despite the fact that this is a static process, the resistance to wound tension increases significantly. The other characteristic of Fibroplasia is a dynamic physical process that results in a multidimensional contraction of the wound. This characteristic component of Fibroplasia is due to the active cellular contraction of myofibroblasts.

I read morphologically myoblastic contraction of the wound will visualize as a two-dimensional stretching of the skin surface.

In general, the effect of Fibroplasia is dermal contraction together with the deposition of a static support scaffold of the neo-collagen with a tensioned structure. The clinical effect is seen as delayed skin tightening without smoothing the skin texture for several months. The clinical endpoint is generally a younger looking skin envelope from the treatment area.

A third and final phase of the delayed wound healing response is maturation. During this phase there is a tensioning and remodeling of the treatment area due to an increased entanglement of the matrix of collagen fibrils (from the dermis). This final stage begins within six to twelve months after the laceration and can last for at least one to two years. Small pixelated skin excisions should preserve normal dermal architecture during this delayed wound healing process without creating an obvious scar that typically occurs with a larger surgical removal of the skin. Finally, there is a related stimulation and rejuvenation of the epidermis from the release of epidermal growth hormone. The delayed wound healing response can be evoked, with deposition of scar collagen, within tissues (such as muscle or fat) with a minimal pre-existing collagen matrix.

Aside from skin tightening for aesthetic purposes, medical pixel delivery systems, instruments or devices, and the methods described herein may have additional medically related applications. In some embodiments, pixel delivery devices can transect a variable portion of soft tissue structures without resorting to standard surgical removal. More specifically, reducing an actinic damaged area of ​​the skin via pixel delivery devices should reduce the incidence of skin cancer. For the treatment of sleep apnea and snoring, a pixelated mucosal reduction (soft palate, tongue base, and lateral pharyngeal walls) via pixel distribution devices would reduce the significant morbidity associated with more standard surgical procedures. For vaginal vault delivery injuries, pixelated vaginal and skin resection would reestablish normal prepartum function and geometry without resorting to A&amp;P excision. Related female stress incontinence could also be corrected in a similar way.

Another embodiment of medical pixel distribution devices described herein includes a device comprising an array of oscillating flat scalpets and the blade either electrically activated or manually deployed (without power) and used for skin tightening as an alternative to the drum. / cylinder described herein, under one embodiment. Figure 18B shows a bottom view of an oscillating plane scalpet arrangement and the blade device, under one embodiment. The blade 108 may be a fenestrated layer of the blade aligned to the scalpet arrangement 106. The handle of the instrument 102 is separated from the handle of the blade 103 and the adherent membrane 110 may be separated from the adhesive backing 111. Figure 18C is a rough view of the flat array when the scalpet array 106, the blades 108, the adherent membrane 110 and the adhesive backing 111 are assembled together, in one embodiment. As an assembly, the flat scalpet arrangement can be measured to provide uniform harvesting or uniform resection. In some embodiments, the flat scalpet arrangement further includes a feeder component 115 for the adherent collection membrane 110 and adhesive backing 111. Figure 18D is a maximized view of the flat scalpet arrangement with a feeder component 115, under one embodiment.

In another embodiment of the skin graft, the pixel graft is placed in a cadaver irradiated dermal matrix (not shown). When grown in the dermal matrix, a full-thickness skin graft is created for the patient that is immunologically identical to the pixel donor. In modalities, the cadaveric dermal matrix can also be cylindrically transected similar in size to skin pixel grafts to provide histological alignment of the pixelated graft in the dermal structure of the cadaver. Figure 19 shows a cylindrically transected cadaveric dermal matrix similar in size to the collected skin pixel grafts, under one modality. In some modalities, the collection percentage of the donor site can be determined in part by induction of normal dermal histology at the site with defective recipient skin, i.e., a normal (more uniform) surface topology of the skin graft is facilitated . With either the adherent membrane or dermal matrix modality, the pixel drum collector includes the ability to collect a large surface area for the graft with the visible scarring of the patient's donor site significantly reduced or removed.

In addition to the medical pixel delivery devices described herein, the embodiments include drug delivery devices. For the most part, parenteral drug delivery is still accomplished by injection with a syringe and needle. To avoid the negative characteristics of the needle and syringe system, topical absorption of the drug was developed transcutaneously through an occlusive patch. However, both drug delivery systems have significant drawbacks. Human aversion to needle injection has not been subdued for nearly two centuries of its use. Variable systemic absorption of any subcutaneous or intramuscular injection of drug reduces the efficacy of the drug and may increase the incidence of adverse patient responses. Depending on the fluid lipid or aqueous carrier of the drug, the topically applied occlusive patch is riddled with variable absorption across the epidermal barrier. For patients requiring local anesthesia over a large surface area of ​​the skin, neither syringe / needle injections nor local anesthetics are ideal. Injections in the syringe / needle field are often painful and can instill excessive amounts of local anesthetic that can cause systemic toxicity.

Local anesthetics rarely provide the level of anesthesia required for skin related procedures.

Figure 20 is a 20 0 drum set drug delivery device, in one embodiment. The drug delivery device 200 successfully addresses the limitations and drawbacks of other drug delivery systems. The device comprises a drum / cylinder 202 supported by a shaft / handle assembly 204 and rotates around a drum rotation component 206. Lug assembly 204 of one embodiment further includes a reservoir 208 of drugs to be delivered and a syringe plunger 210. The surface of drum 202 is covered by a needle array 212 of uniform length, which provides a uniform intradermal injection depth (or subdermal) with a more controlled volume of the drug injected into the patient's skin. During operation, the plunger of syringe 210 drives the drug out of reservoir 208 to be injected into a sealed injection chamber 214 into drum 202 via a connecting tube 216. The drug is eventually delivered into the patient's skin at a depth uniform when needle array 212 is pushed into the patient's skin until the surface of drum 202 collides with the skin. The skipped non-anesthetized area is avoided and a more uniform pattern of skin anesthesia is created. Application of the rotating drum of the drug delivery device 200 also instills local anesthesia faster with less discomfort to the patient.

FIG. 21A is a side view of a needle fixation drug delivery device 300, in one embodiment. Figure 21B is a top isometric view of a needle fixation drug delivery device 300, in one embodiment. FIG. 21C is a bottom isometric view of a needle array drug delivery device 300, in one embodiment. The drug delivery device 300 comprises the flat distribution of fine needles 312 of uniform length placed in a dispenser 310 can be used for drug delivery. In this exemplary embodiment, syringe 302 containing the drug for injection can be connected to a disposable adapter 306 with lugs, and a seal 308 can be used to ensure that syringe 3 02 and disposable adapter 306 fit securely. each. When the plunger of syringe 304 is pushed, the drug contained in syringe 302 is delivered from syringe 302 to disposable adapter 306. The drug is further delivered to the patient's skin through the flat array of fine needles at a uniform depth when needle array 312 is pushed into the patient's skin until distributor 310 collides with the skin.

The use of the drug delivery device 200 may have as many clinical applications as the number of pharmacological agents requiring transcutaneous injection or absorption. For the non-limiting examples, a few of the potential applications are injection of local anesthetics, injection of neuromodulators such as botulinum toxin (Botox), injection of insulin, and injection of estrogens and replacement corticosteroids.

In some embodiments, the plunger of syringe 210 of drug delivery device 200 can be energized by, for a non-limiting example, an electric motor. In some embodiments, a fluid pump (not shown) coupled to an IV bag and tubing can connect to the IV injection chamber and the tubing can connect to the injection chamber 214 and / or reservoir 208 for continuous injection. In some embodiments, the volume of the syringe plunger 210 in the drug delivery device 200 is calibrated and programmable.

Pixelated Skin Graft for Skin Defects and Pixelated Skin Resection for Flabby Skin are described in detail herein, for example, with reference to Figures 1-10D. Pixel skin grafting with the PAD (Pixel Distribution Dermatome) device of one modality is used in the treatment of Alopecia. Alopecia, or male pattern baldness, is a sex-linked trait that is transferred by the mother's X chromosome. For men, only one gene is needed to express this phenotype. Because the gene is recessive, female pattern baldness requires the transfer of both X-linked genes from both the father and mother.

Phenotypic penetration can vary from patient to patient and is most frequently expressed in the age of onset and the amount of frontal / partial / occipital alopecia. Other non-genetic related etiologies are seen in a more limited segment of the population. These non-genetic etiologies include trauma, fungal infections, lupus erythematosus, radiation, and chemotherapy.

A wide variety of baldness treatment options have been proposed, including FDA-approved topical medications such as Minoxidil and Finasteride that had limited success as these agents require the conversion of inactive hair follicles to a growth or anagen phase. Other remedies include toupees and hair weaves. The standard of practice remains in surgical hair transplantation, which involves the transfer of hair strands, strands, and strands from the scalp that wears to the scalp that does not have hair. For the most part, conventional hair transplantation involves the transfer of multiple individual hair micrographs from the scalp that carries the hair to the scalp that does not carry hair from the same patient. Alternatively, the donor locks are initially collected as strips of hair and then secondarily sectioned into micrographs for transfer to the recipient scalp. Regardless, this multi-stage procedure is both tedious and expensive, involving several hours of surgery for the average patient.

Mass collection of hair-bearing locks in the mass transplant of hair-bearing locks into a hairless scalp will largely truncate conventional surgical procedures of hair transplantation. Generally, the devices, systems and / or methods of one modality are used to collect and align a large multiplicity of small tufts that carry hair in a single step or surgical process, and the same instrumentation is used to prepare the recipient site by performing a multiple pixelated resection of scalp that does not have hair. The multiple multi-tuft graft is transferred and transplanted en masse to the prepared recipient site. Consequently, through the use of a two-step procedure, hundreds of strands of hair can be transferred from a donor site to a recipient site. Hair transplantation using the modalities described herein therefore provides a solution that is an easy, simple, individual surgical procedure with a significant time reduction over the conventional tedious and multi-stage process.

More particularly, under one modality procedure the hair follicles to be collected are taken from the donor's occipital scalp. In doing so, the hair from the partially shaved donor site, and the perforated plate of one modality are located on the scalp and oriented to provide maximum collection. Figure 22 shows the collection of donor follicles, under one modality. The scalpets in the scalpet arrangement are configured to penetrate down the subcutaneous fat after capture of the hair follicle. Once the strands of hair are incised, they are collected onto the adhesive membrane by transecting the base of the strand of hair with the transecting blade, as described in detail herein. The original alignment of the hair strands with respect to each other at the donor site is maintained by applying the adherent membrane before transecting the base. The aligned matrix of the hair strands on the adherent membrane will then be grafted en masse to a receptor site on the recipient's frontal-parietal scalp.

Figure 23 shows the preparation of the receptor site, under one modality. The recipient site is prepared by resection of hairless skin inserts in a topographically identical pattern as the collected occipital scalp donor site. The recipient site is prepared by mass transplanting the strands of hair using the same instrumentation that was used at the donor site under one modality, and in doing so, defects of the scalp are created at the recipient site. Scalp defects created at the receptor site have the same geometry as the strands collected on the adherent membrane.

The adherent membrane loaded with the collected strands of hair is applied over the same pattern of scalp defects at the receptor site. Row by row, each tuft with hair is inserted in its defect of the mirror image receptor. Figure 24 shows the placement of the collected strands of hair at the receptor site, under one modality. The strand-by-strand alignment is maintained so that the hair grows from the transplanted strands of hair positioned as is naturally done at the donor site. The most even alignment between the native scalp and the transplanted hair will also occur.

The modalities described herein include a method comprising placing a guide plate at a donor site. The method involves aligning a device scalpet arrangement with the guide plate at the donor site. The scalpet arrangement comprises at least one scalpet. The method involves incising skin pixels at the donor site with the scalpet arrangement. The method involves preparing a receptor site by placing the guide plate at the receptor site, and generating with the scalpet arrangement defective skin. The method involves applying the incised skin pixels to the recipient site.

The modalities described herein include a method comprising: placing a guide plate at a donor site; aligning a device scalpet array with the guide plate at the donor site, where the scalpet array comprises at least one scalpet; incise the pixels of the skin at the donor site with the scalpet arrangement; prepare a receptor site by placing the guide plate at the receptor site, and generate with the scalpet arrangement defective skin; and apply the incised skin pixels at the receiving site.

The guide plate comprises perforations arranged in a configuration.

The at least one scalpet comprises a plurality of sc alpets arranged in the configuration.

The scalpet arrangement is arranged according to the configuration.

The alignment comprises the alignment of the scalpet arrangement with at least one group of perforations.

A single scalpet is aligned to make incisions through at least one set of perforations.

The at least one scalpet comprises a single scalpet, and the alignment comprises repeatedly applying the scalpet arrangement to the donor site in accordance with an order of at least one group of perforations.

The incision involves applying the scalpet arrangement to the donor site directly through at least one set of perforations.

The incision generates skin pixels with incisions in the configuration.

The incised skin pixels comprise at least one hair follicle.

Preparation of the receptor site involves aligning the scalpet arrangement with the guide plate.

Generating flawed skin involves applying the scalpet arrangement to the receptor site directly through at least one set of perforations.

Generation involves generating the defective skin with the same geometry as that of the skin pixels with incisions from a donor site.

The incision involves making circumferential incisions in the pixels of the skin at the donor site by applying a load of the scalpet arrangement on the underlying surface of the skin at the donor site.

The method involves transecting skin pixel bases with extruded incisions through the perforations as a result of the incision.

The transection comprises transection with a cutting member.

The method comprises configuring the guide plate with a plate frame, and coupling the cutting member to the plate frame.

The method comprises capturing the skin pixels with incisions on an adherent substrate.

The method comprises aligning incised skin pixels on the adherent substrate, where the incised skin pixels include hair follicles.

The incised skin pixels are extruded through the perforations.

The method involves pulling the adherent substrate away from the donor site and transecting the bases of the incised skin pixels during entrainment.

The adherent substrate comprises a flexible substrate.

The adherent substrate comprises a porous membrane.

The method comprises configuring the guide plate with a plate frame, and coupling the adherent substrate to at least one of the guide plate and the plate frame.

The method comprises attaching the adherent substrate to at least one of the guide plate and the plate frame after making the incisions.

Application of the incised skin pixels comprises applying the incised skin pixels of the adherent substrate directly to the defective skin at the receptor site.

Application of incised skin pixels involves aligning incised skin pixels with defective skin at the donor site.

The alignment comprises the alignment of the mass of the skin pixels with incisions according to the configuration.

Incised skin pixels include hair follicles.

Application of the incised skin pixels at the recipient site comprises inserting the corresponding defective skin incised skin pixels at the recipient site.

The method involves applying a first dressing to the donor site after making the skin pixel incisions, where the first dressing closes the donor site and controls the direction in which the defective skin at the donor site closes.

The method comprises applying a second bandage to the receptor site after application of the skin pixels with incisions at the receptor site, where the second bandage generates a force at the receptor site.

The second bandage comprises an adherent membrane.

The second bandage is configured to capture incised skin pixels at the donor site.

The second bandage is configured to stabilize the skin pixels with incisions inserted into the recipient site.

The second bandage is configured to promote neovascularization of the skin pixels with incisions inserted at the recipient site.

The second bandage is configured to promote alignment of the skin pixels with incisions inserted into the recipient site.

The method comprises providing the device with the scalpet arrangement as a separate component of the guide plate.

Placement of the guide plate involves applying the guide plate directly to a surface of the skin at the donor site.

<td></td><td>A</td><td>shape</td><td>of</td><td>every</td><td>scalpet</td><td>of the</td><td>arrangement</td><td>scalpet</td><td>is</td>

<td>elliptical.</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td></td><td>A</td><td>shape</td><td>of</td><td>every</td><td>scalpet</td><td>of the</td><td>arrangement</td><td>scalpet</td><td>is</td>

<td>circular.</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td></td><td>A</td><td>shape</td><td>of</td><td>every</td><td>scalpet</td><td>of the</td><td>arrangement</td><td>scalpet</td><td>is</td>

semicircular.

One shape of each scalpet in the scalpet arrangement is one of square, rectangular, and flat.

<td></td><td>Every scalpet</td><td>of</td><td>moon plurality</td><td>of</td><td>scalpets</td><td>It includes</td>

<td>a</td><td>. beveled surface</td><td> •</td><td></td><td></td><td></td><td></td>

<td></td><td>Every scalpet</td><td>of</td><td>moon plurality</td><td>of</td><td>scalpets</td><td>It includes</td>

<td>to the</td><td>minus one surface</td><td colspan="2">pointy.</td><td></td><td></td><td></td>

<td></td><td>Every scalpet</td><td>of</td><td>moon plurality</td><td>of</td><td>scalpets</td><td>It includes</td>

<td>to the</td><td>minus a needle.</td><td></td><td></td><td></td><td></td><td></td>

<td></td><td colspan="2">The at least one</td><td>Needle understands</td><td>to the</td><td colspan="2">minus a needle</td>

including multiple points.

At least one scalpet in the scalpet arrangement comprises a through hole.

The scalpet array is removably attached to the device.

The scalpet arrangement is disposable.

At least one diametrical dimension of each scalpet in the scalpet array is approximately in the range of 0.5 millimeters to 4.0 millimeters.

Incised skin pixels include hair follicles.

The modalities described herein include a method comprising placing a collection pattern at a donor site. The method involves aligning a device scalpet arrangement with the collection pattern at the donor site. The scalpet arrangement comprises at least one scalpet. The method involves making incisions of the skin pixels at the donor site with the scalpet arrangement. The method involves preparing a receptor site by placing the collection pattern at the receptor site, and generating with the scalpet arrangement defective skin. The method involves applying the incised skin pixels to the recipient site.

The modalities described herein include a method comprising: placing a collection pattern at a donor site; aligning a device scalpet array with the collection pattern at the donor site, where the scalpet array comprises at least one scalpet; incise the pixels of the skin at the donor site with the scalpet arrangement; preparing a receptor site by placing the collection pattern on the receptor site, and generating with the scalpet arrangement defective skin; and apply the incised skin pixels at the receiving site.

The collection pattern comprises indicators on a skin surface in at least one of the donor site and the recipient site.

The at least one scalpet comprises a plurality of scalpets arranged according to the collection pattern.

The scalpet arrangement is arranged according to the collection pattern.

The alignment comprises the alignment of the scalpet arrangement with at least one group of indicators.

The at least one scalpet comprises a single scalpet, and the alignment comprises repeatedly applying the scalpet arrangement to the donor site in accordance with an order of at least one group of indicators.

The incision involves applying the scalpet arrangement to the donor site directly according to at least one group of indicators.

The modalities described herein include a method comprising placing a guide plate at a donor site. The guide plate comprises perforations arranged in a configuration. The method involves aligning a scalpet arrangement of a device with the guide plate at the donor site. The scalpet arrangement comprises a plurality of scalpets arranged in the configuration, and the alignment comprises aligning the scalpet arrangement with at least one set of perforations. The method involves making incisions of the skin pixels at the donor site with the scalpet arrangement. The method involves preparing a receptor site by placing the guide plate at the receptor site, aligning the scalpet arrangement with the guide plate, and generating with the scalpet arrangement defective skin with the same geometry as the incised skin pixels. The method involves applying the incised skin pixels to the recipient site.

The modalities described herein include a method comprising: placing a guide plate at a donor site, wherein the guide plate comprises perforations arranged in a configuration; aligning a device scalpet array with the guide plate at the donor site, where the scalpet array comprises a plurality of scalpets arranged in the configuration, and the alignment comprises aligning the scalpet array with at least one set of perforations ; incise the pixels of the skin at the donor site with the scalpet arrangement; Prepare a receptor site by placing the guide plate at the receptor site, aligning the scalpet arrangement with the guide plate, and generating with the scalpet arrangement defective skin with the same geometry as the incised skin pixels; and apply the incised skin pixels at the receiving site.

The modalities described herein include a method comprising placing a guide plate at a donor site. The guide plate comprises perforations arranged in a configuration. The method involves aligning a scalpet arrangement of a device with the guide plate at the donor site. The scalpet arrangement comprises a plurality of scalpets arranged in the configuration, and the alignment comprises aligning the scalpet arrangement with at least one set of perforations. The method involves making incisions of the skin pixels at the donor site with the scalpet arrangement. The method comprises preparing a b-receptor site and generating with the scalpet fix defective skin in the configuration. The method involves applying the incised skin pixels to the recipient site.

The modalities described herein include a method comprising: placing a guide plate at a donor site, wherein the guide plate comprises perforations arranged in a configuration; aligning a device scalpet array with the guide plate at the donor site, where the scalpet array comprises a plurality of scalpets arranged in the configuration, and the alignment comprises aligning the scalpet array with at least one set of perforations ; incise the pixels of the skin at the donor site with the scalpet arrangement; prepare a b-receptor site generating faulty skin in the configuration with the scalpet fix; and apply the incised skin pixels at the receiving site.

The modalities described herein include a method comprising placing a guide plate at a donor site. The guide plate comprises perforations arranged in a configuration. The method involves aligning a scalpet arrangement of a device with the guide plate at the donor site. The scalpet arrangement comprises a plurality of scalpets arranged in the configuration, and the alignment comprises aligning the scalpet arrangement with at least one set of perforations. The method involves making incisions of the skin pixels at the donor site with the scalpet arrangement. The method involves capturing the incised skin pixels and keeping the incised pixels in the configuration.

The modalities described herein include a method comprising: placing a guide plate at a donor site, wherein the guide plate comprises perforations arranged in a configuration; aligning a device scalpet array with the guide plate at the donor site, where the scalpet array comprises a plurality of scalpets arranged in the configuration, and the alignment comprises aligning the scalpet array with at least one set of perforations ; incise the pixels of the skin at the donor site with the scalpet arrangement; and capture incised skin pixels and keep incised pixels in settings.

The modalities described herein include a method comprising aligning a scalpet array of a device at a donor site. The scalpet arrangement comprises a plurality of scalpets arranged in one configuration. The method involves making incisions of the skin pixels at the donor site with the scalpet arrangement. The method comprises capturing the incised skin pixels and removing the incised skin pixels from the donor site; and transfer the captured incision pixels away from the donor site while keeping the incised pixels in the configuration.

The modalities described herein include a method comprising: aligning a scalpet array of a device at a donor site, wherein the scalpet array comprises a plurality of scalpets arranged in one configuration; incise the pixels of the skin at the donor site with the scalpet arrangement; and capturing the incised skin pixels and removing the incised skin pixels from the donor site; and transfer the captured incision pixels away from the donor site while keeping the incised pixels in the configuration.

The modalities described herein include a method comprising aligning a scalpet array of a device at a donor site. The scalpet array comprises at least one scalpet arranged in a configuration. The method involves making incisions of the skin pixels at the donor site with the scalpet arrangement. The method involves capturing the incised skin pixels and transferring them to a receiving site while maintaining the configuration. The method involves generating defective skin at the receptor site with the scalpet arrangement. The method involves applying the incised skin pixels to the recipient site.

The modalities described herein include a method comprising: aligning a scalpet array of a device at a donor site, wherein the scalpet array comprises at least one scalpet arranged in a configuration; incise the pixels of the skin at the donor site with the scalpet arrangement; capture incised skin pixels and transfer them to a receiving site while maintaining settings; generate defective skin at the receptor site with the scalpet fix; and apply the incised skin pixels at the receiving site.

The at least one scalpet comprises a plurality of scalpets arranged in the configuration.

The at least one scalpet comprises a single scalpet, and the alignment comprises repeatedly applying the scalpet arrangement to the donor site in accordance with an order.

The incision generates skin pixels with incisions in the configuration.

The incised skin pixels comprise at least one hair follicle.

Generation comprises generating the defective skin with the same configuration as that of the skin pixels with incisions from the donor site.

The incision involves making circumferential incisions in the pixels of the skin at the donor site by applying a load of the scalpet arrangement on the underlying surface of the skin at the donor site.

The method comprises transecting skin pixel bases with extruded incisions during the incision operation.

The transection comprises transection with a cutting member.

Capture involves capturing the skin pixels incised onto a sticky substrate.

The method comprises aligning incised skin pixels on the adherent substrate, where the incised skin pixels include hair follicles.

The method involves pulling the adherent substrate away from the donor site and transecting the bases of the incised skin pixels during entrainment.

The adherent substrate comprises a flexible substrate.

The adherent substrate comprises a semi-porous membrane.

Application of the incised skin pixels comprises applying the incised skin pixels of the adherent substrate directly to the defective skin at the receptor site.

Application of incised skin pixels involves aligning incised skin pixels with defective skin at the donor site.

The alignment comprises the alignment of the mass of the skin pixels with incisions according to the configuration.

Incised skin pixels include hair follicles.

Application of the incised skin pixels at the recipient site comprises inserting the corresponding defective skin incised skin pixels at the recipient site.

The method involves applying a first dressing to the donor site after making the skin pixel incisions, where the first dressing closes the donor site and controls the direction in which the defective skin at the donor site closes.

The method comprises applying a second bandage to the receptor site after application of the skin pixels with incisions at the receptor site, where the second bandage generates a force at the receptor site.

The second bandage comprises an adherent membrane.

The second bandage is configured to capture incised skin pixels at the donor site.

The second bandage is configured to stabilize the skin pixels with incisions inserted into the recipient site.

The second bandage is configured to promote neovascularization of the skin pixels with incisions inserted at the recipient site.

The second bandage is configured to promote alignment of the skin pixels with incisions inserted into

<td rowspan="2">the place</td><td colspan="4">receiver.</td><td rowspan="2">scalpet</td><td rowspan="2">of the</td><td rowspan="2">arrangement</td><td rowspan="2">scalpet</td><td rowspan="2">is</td>

<td>A</td><td>shape</td><td>of</td><td>every</td>

<td>elliptical.</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td></td><td>A</td><td>shape</td><td>of</td><td>every</td><td>scalpet</td><td>of the</td><td>arrangement</td><td>scalpet</td><td>is</td>

<td>circular.</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td></td><td>A</td><td>shape</td><td>of</td><td>every</td><td>scalpet</td><td>of the</td><td>arrangement</td><td>scalpet</td><td>is</td>

semicircular.

One shape of each scalpet in the scalpet arrangement is one of square, rectangular, and flat.

Each moon scalpet plurality of scalpets includes a beveled surface.

Each moon scalpet plurality of scalpets includes at least one pointed surface. Each moon scalpet plurality of scalpets includes at least one needle.

The at least one needle comprises at least one needle including multiple stitches. At least one scalpet in the scalpet arrangement comprises a through hole.

The scalpet array is removably attached to the device.

The scalpet arrangement is disposable.

At least one diametrical dimension of each scalpet in the scalpet array is approximately in the range of 0.5 millimeters to 4.0 millimeters.

Incised skin pixels include hair follicles.

The modalities described herein include a system comprising a collection pattern placed at a donor site and a recipient site. The system includes a device that comprises a scalpet arrangement that includes at least one scalpet. The at least one scalpet is configured to align with the collection pattern. The at least one scalpet is configured to make skin pixel incisions at the donor site and generate defective skin at the recipient site. The system includes an adherent substrate configured to capture incised skin pixels at the donor site and maintain relative placement of incised skin pixels during transfer to the recipient site and application of incised skin pixels at the site receiver.

The modalities described herein include a system comprising: a collection pattern placed at a donor site and a recipient site; a device comprising a scalpet array including at least one scalpet, wherein the at least one scalpet is configured to align with the harvest pattern, wherein the at least one scalpet is configured to make skin pixel incisions in the donor site and generate defective skin at the recipient site; and an adherent substrate configured to capture the incised skin pixels at the donor site and maintain the relative placement of the incised skin pixels during transfer to the recipient site and the application of the incised skin pixels at the recipient site.

The collection pattern is on a skin surface in at least one of the donor site and the recipient site.

The collection pattern comprises an indicator on a skin surface at least one of the donor site and the recipient site.

The scalpet array is removably attached to the device.

The scalpet arrangement is disposable.

<td></td><td>A</td><td>shape</td><td>of</td><td>every</td><td>scalpet</td><td>of the</td><td>arrangement</td><td>scalpet is</td>

<td>elliptical.</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td></td><td>A</td><td>shape</td><td>of</td><td>every</td><td>scalpet</td><td>of the</td><td>arrangement</td><td>scalpet is</td>

<td>circular.</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

One way to each scalpet in the scalpet arrangement is semicircular.

One shape of each scalpet in the scalpet arrangement is one of square, rectangular, and flat.

Each scalpet of the at least one scalpet includes a beveled surface.

Each moon scalpet plurality of scalpets includes at least one pointed surface.

Each moon scalpet plurality of scalpets includes at least one needle.

The at least one needle comprises at least one needle including multiple stitches.

The scalpet arrangement generates the incised skin pixels using at least one of a piercing force, impact force, rotational force, and vibration.

At least one scalpet in the scalpet arrangement comprises a through hole.

At least one diametrical dimension of each scalpet in the scalpet array is approximately in the range of 0.5 millimeters to 4.0 millimeters.

The adherent substrate comprises a flexible substrate.

The adherent substrate comprises a porous membrane.

The at least one scalpet on the device is arranged to correspond to the collection pattern.

The at least one scalpet on the device is configured to align with the collection pattern.

The scalpet arrangement is applied to the donor site directly according to the collection pattern, and incised in the skin pixels.

The adherent substrate is configured to hold the incised skin pixels according to the harvesting pattern during transfer and application of the incised skin pixels at the receiving site.

The scalpet arrangement is applied to the recipient site directly according to the collection pattern and the defective skin is generated.

Defective skin is generated according to the collection pattern.

The system comprises a guide plate comprising perforations arranged in a configuration corresponding to the collection pattern.

The guide plate is placed directly on a skin surface at one of the donor site and the recipient site.

The guide plate is configured to extrude the incised skin pixels.

The skin pixels are extruded through the perforations in response to the applied load.

The skin pixels are extruded through the skin surface with incisions in response to the applied load.

Incised skin pixels from the donor site and defective skin from the recipient site are arranged in the configuration.

The incised skin pixels of the donor site comprise a first configuration and the defective skin of the recipient site comprises a second configuration, wherein the first configuration and the second configuration are different.

The at least one scalpet in the device is configured to align with at least one group of guide plate moon holes.

The scalpet arrangement is applied to the donor site directly through at least one set of perforations and is incised at the skin pixels.

The adherent substrate is configured to keep the incised skin pixels in the configuration during transfer and application of the incised skin pixels at the receptor site.

The scalpet arrangement is applied to the receptor site directly through at least one group of perforations and the defective skin is generated.

Defective skin is generated according to the configuration.

The guide plate is at least one of adherent, rigid, semi-rigid, conform, do not conform, and do not deform.

The guide plate includes at least one metallic, plastic, polymeric, and membranous material.

The guide plate is configured to transmit a load to a skin surface of at least one of the donor site and the recipient site.

The scalpet arrangement is configured to transfer a load to the underlying skin surface that includes the donor site, where circumferential incisions are made in the skin pixels by applying the load.

The system comprises a cutting member.

The incised skin pixels are extruded, where the extruded skin pixels are transected by the cutting member.

The adherent substrate is pulled away from the donor site, and the bases of the incised skin pixels are transected by the cutting member.

The cutting member is applied to a frame of the plate.

The plate frame attaches to a guide plate.

The adherent substrate attaches to at least one of the guide plate and the plate frame.

The incised skin pixels are applied directly from the adherent substrate to the defective skin at the receptor site.

The incised skin pixels align with the defective skin at the receptor site. Each pixel of skin in the incision is inserted into a corresponding skin defect at the recipient site.

The system comprises applying a first bandage to the donor site after making the skin pixel incisions, where the first bandage closes the donor site and controls the direction in which the defective skin at the donor site closes.

The system comprises applying a second bandage to the receptor site after application of the skin pixels with incisions at the receptor site, where the second bandage generates a force at the receptor site.

Incised skin pixels include hair follicles.

The defective skin is configured to evoke neovascularization in the skin pixels with incisions inserted at the receptor site.

The defective skin is configured to evoke a wound healing response in the skin pixels with incisions inserted at the receptor site.

The modalities described herein include a system comprising a collection pattern including indicators arranged in a configuration. The collection pattern is configured to be placed at a target site and a recipient site. The system includes a device that comprises a scalpet arrangement that includes a plurality of scalpets arranged in the configuration. The plurality of scalpets is configured to align with at least one group of indicators. The plurality of scalpets is configured to make skin pixel incisions at the target site and generate defective skin at the recipient site. The system includes a tacky substrate configured to capture incised skin pixels at the target site and maintain configuration during application of incised skin pixels at the recipient site.

The modalities described herein include a system comprising: a collection pattern including indicators arranged in a configuration, wherein the collection pattern is configured to be placed at a target site and a recipient site; a device comprising a scalpet arrangement including a plurality of scalpets arranged in the configuration, wherein the plurality of scalpets is configured to align with at least one group of indicators, where the plurality of scalpets are configured to make pixel incisions skin at the target site and generate defective skin at the recipient site; and an adherent substrate configured to capture the incised skin pixels at the target site and maintain the configuration during application of the incised skin pixels at the recipient site.

The modalities described herein include a system comprising a collection pattern including indicators arranged in a configuration. The collection pattern is configured to be placed at a target site and a recipient site. The system includes a device that comprises a scalpet arrangement that includes a plurality of scalpets arranged in the configuration. The plurality of scalpets is configured to align with at least one group of indicators. The plurality of scalpets is configured to make skin pixel incisions at the target site and generate defective skin at the recipient site.

The modalities described herein include a system comprising: a collection pattern including indicators arranged in a configuration, wherein the collection pattern is configured to be placed at a target site and a recipient site; and a device comprising a scalpet arrangement including a plurality of scalpets arranged in the configuration, wherein the plurality of scalpets is configured to align with at least one group of indicators, where the plurality of scalpets are configured to make incisions of pixels of skin at the target site and generating faulty skin at the recipient site.

The embodiments described herein include a system comprising a guide plate including perforations arranged in a configuration. The guide plate is configured to be placed at a target site and a receptor site. The system includes a device that comprises a scalpet arrangement that includes a plurality of scalpets arranged in the configuration. The plurality of scalpets are configured to align with at least one group of perforations. The plurality of scalpets is configured to make skin pixel incisions at the target site and generate defective skin at the recipient site. The system includes a tacky substrate configured to capture incised skin pixels at the target site and maintain configuration during application of incised skin pixels at the recipient site.

The embodiments described herein include a system comprising: a guide plate including perforations arranged in a configuration, wherein the guide plate is configured to be placed at a target site and a receptor site; a device comprising a scalpet arrangement including a plurality of scalpets arranged in the configuration, wherein the plurality of scalpets is configured to align with at least one group of perforations, where the plurality of scalpets are configured to make pixel incisions skin at the target site and generate defective skin at the recipient site; and an adherent substrate configured to capture the incised skin pixels at the target site and maintain the configuration during application of the incised skin pixels at the recipient site.

The embodiments described herein include a system comprising a guide plate including perforations arranged in a configuration. The guide plate is configured to be placed at a target site and a receptor site. The system includes a device that comprises a scalpet arrangement that includes a plurality of scalpets arranged in the configuration. The plurality of scalpets are configured to align with at least one group of perforations. The plurality of scalpets is configured to make skin pixel incisions at the target site and generate defective skin at the recipient site.

The embodiments described herein include a system comprising: a guide plate including perforations arranged in a configuration, wherein the guide plate is configured to be placed at a target site and a receptor site; and a device comprising a scalpet arrangement including a plurality of scalpets arranged in the configuration, wherein the plurality of scalpets are configured to align with at least one group of perforations, wherein the plurality of scalpets are configured to make incisions of pixels of skin at the target site and generating faulty skin at the recipient site.

The modalities described herein include a method that comprises applying a scalpet fix to a target skin site. The scalpet arrangement comprises a plurality of scalpets placed on an inversion plate. The inversion plate is a perforated plate. The method comprises making circumferential incisions in the skin pixels at the target skin site by applying a load of the scalpet arrangement on the underlying skin surface that includes the target skin site. The method comprises capturing a plurality of skin pixels incised on an adherent substrate. The incised skin pixels are extruded through the scalpet arrangement. The method involves transecting skin pixel bases with extruded incisions through the scalpet arrangement.

The modalities described herein include a method comprising: applying a scalpet arrangement to a target skin site, wherein the scalpet arrangement comprises a plurality of scalpets placed on an inversion plate, wherein the inversion plate is a perforated plate; making circumferential incisions in the pixels of the skin at the target skin site by applying a load of the scalpet arrangement on the underlying skin surface that includes the target skin site; capturing a plurality of incised skin pixels on an adherent substrate, where the incised skin pixels are extruded through the scalpet arrangement; and transect skin pixel bases with extruded incisions through the scalpet arrangement.

The application of the load of a modality includes applying the load with a Dermatome.

The one-method method involves configuring at least one dimension of the scalpet array to be consistent with at least one dimension of the Dermatome.

One modality method comprises providing the scalpet arrangement as a separate component of the Dermatome.

The one-method approach involves applying the scalpet fix directly to the target skin site.

The modality method involves removably attaching the scalpet arrangement to the Dermatome.

The method of one embodiment comprises coupling the adherent substrate to the Dermatome.

The method of one modality comprises attaching the adherent substrate to the Dermatome before applying the load.

The method of one embodiment comprises coupling the adherent substrate to the Dermatome after the application of the load.

The method of one modality comprises attaching the scalpet arrangement to the Dermatome before applying the load. The method of one embodiment comprises replacing the scalpet arrangement with the adherent substrate after application of the load.

The transection of a modality comprises transection with a cutting member that is a component of the Dermatome.

The method of one embodiment comprises configuring each scalpet of the plurality of scalpets with a beveled surface.

The application of the load of a modality includes applying the load with a drum Dermatome.

The method of one embodiment comprises configuring at least one dimension of the scalpet arrangement to be consistent with at least one dimension of a drum Dermatome drum.

<td></td><td>The</td><td>method</td><td>of a</td><td>modality</td><td>understands</td><td>couple</td><td>the</td>

<td>substratum</td><td colspan="2">adherent</td><td colspan="2">to the drum before</td><td colspan="2">the application of</td><td>the</td>

<td>load.</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td></td><td>The</td><td>method</td><td>of a</td><td>modality</td><td>understands</td><td>couple</td><td>the</td>

<td>substratum</td><td colspan="2">adherent</td><td colspan="4">to the drum after applying</td><td>the</td>

<td>load.</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td></td><td>The</td><td>method</td><td>of a</td><td>modality</td><td>understands</td><td>provide</td><td>the</td>

<td>arrangement</td><td>of the</td><td>scalpet</td><td>as a</td><td>component</td><td colspan="3">separated from the Dermatome</td>

drum.

<td></td><td>The</td><td>method</td><td>of a modality</td><td>understands</td><td>place the</td>

<td>arrangement</td><td>of the</td><td>scalpet</td><td>directly in</td><td>the place</td><td>of the skin</td>

<td>objective</td><td colspan="2">before the</td><td colspan="2">application of the load.</td><td></td>

<td></td><td>The</td><td>method</td><td>of a modality</td><td>understands</td><td>dock the</td>

drum adherent substrate before load application.

The method of one embodiment comprises removably attaching the scalpet arrangement to the Drum Dermatome prior to application of the load, and applying the Drum Dermatome with the scalpet arrangement to the target skin site.

The method of one embodiment comprises replacing the scalpet arrangement with the adherent substrate after application of the load.

The method of one embodiment comprises applying a template plate directly to a surface of the skin.

The template plate of one embodiment is a perforated plate comprising a first perforation pattern.

The plurality of scalpets of one embodiment comprises a second pattern.

The second pattern in a modality matches the first pattern.

The modal scalpet array is configured to

<td>be applied</td><td>on</td><td>the</td><td>license plate</td><td>template</td><td>in a</td><td>shape</td><td>than</td>

<td>It results in</td><td>do</td><td>with</td><td>the</td><td>perforations</td><td>in the</td><td>license plate</td><td>of</td>

<td>template.</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td>The</td><td>method</td><td>of</td><td>a</td><td colspan="2">modality comprises</td><td>to form</td><td>the</td>

The transection of a modality comprises the arrangement of the scalpet as an integrated component of the Drum Dermatome.

transection with a cutting member. The method of one embodiment comprises coupling the cutting member to the drum Dermatome.

The modalities described herein include a system comprising a scalpet arrangement comprising a plurality of scalpets secured on an inversion plate. The scalpet arrangement is configured for application to a skin surface. The system includes a load member. The load member is configured to apply a load via the scalpet fix to the surface of the skin underlying the scalpet fix. The system includes an adherent substrate configured to capture extruded skin inserts in the incisions through the scalpet arrangement as a result of applying the load. The system includes a cutting member. The cutting member transects the bases of the extruded skin inserts in the inserts through the scalpet arrangement.

The modalities described herein include a system comprising: a scalpet arrangement comprising a plurality of scalpets secured on an inversion plate, wherein the scalpet arrangement is configured for application to a skin surface; a loading member, wherein the loading member is configured to apply via the scalpet arrangement a load on the surface of the underlying skin of the scalpet arrangement; an adherent substrate configured to capture extruded skin inserts in the incisions through the scalpet arrangement as a result of applying the load; and a cutting member, wherein the cutting member transects the bases of the extruded skin inserts in the incisions through the scalpet arrangement.

The charging member of an embodiment comprises a Dermatome.

At least one dimension of the scalpet arrangement of a modality fits at least one dimension of the Dermatome.

The adherent membrane of one embodiment is coupled to the loading member.

The loading member of one embodiment comprises a Dermatome, wherein the adherent substrate is carried in a component of the Dermatome.

The cutting member of one embodiment is coupled to the loading member.

The loading member of one embodiment comprises a Dermatome, wherein the cutting member is a component of the Dermatome.

Each moon scalpet plurality of scalpets of one embodiment comprises a beveled surface.

The charging member of one embodiment comprises a drum Dermatome.

At least one dimension of the scalpet arrangement of a modality fits at least one dimension of a drum of the

Drum dermatome.

The scalpet arrangement of a modality is separate from the Drum Dermatome.

<td></td><td>The</td><td>member</td><td>of</td><td>cut</td><td>of</td><td>a</td><td>modality</td><td>I know</td><td>couple</td><td>to the</td>

<td>Dermatome</td><td>of</td><td>drum.</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td></td><td>The</td><td>member</td><td>of</td><td>cut</td><td>of</td><td>a</td><td>modality</td><td>is</td><td>internal</td><td>to the</td>

<td>drum.</td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td><td></td>

<td></td><td>The</td><td>member</td><td>of</td><td>cut</td><td>of</td><td>a</td><td>modality</td><td>is</td><td>external</td><td>to the</td>

drum.

The adherent substrate of one embodiment is coupled to the drum.

The drum of a modality is an arrangement drum that comprises the arrangement of the scalpet.

The drum of the arrangement of a modality can be separated.

The drum of the arrangement of a modality is disposable.

The adherent substrate of one embodiment is attached to the interior of the array drum.

The modalities described herein include a system comprising a scalpet arrangement comprising a plurality of scalpets secured to an inversion plate. The scalpet arrangement is configured for application to a skin surface. The system includes an adherent substrate configured to capture skin pixels with incisions extruded through the scalpet array as a result of applying a load to the underlying skin surface of the scalpet array. The scalpet arrangement is independent of the adherent substrate.

The modalities described herein include a system comprising: a scalpet arrangement comprising a plurality of scalpets secured to an inversion plate, wherein the scalpet arrangement is configured for application to a skin surface; and an adherent substrate configured to capture skin pixels with incisions extruded through the scalpet array as a result of applying a load to the underlying skin surface of the scalpet array, where the scalpet array is independent of the substrate adherent.

The adherent substrate of a modality is attached to a Dermatome, where the Dermatome is configured to apply the load via the scalpet arrangement.

The Dermatome of one modality includes a cutting member, where the cutting member transects the bases of the extruded skin inserts in the incisions through the scalpet arrangement.

The Dermatome of a modality is a drum Dermatome comprising a drum. The adherent substrate of one embodiment is carried in the drum.

At least one dimension of the scalpet arrangement of a modality is proportional to at least one dimension of the drum.

The drum of a modality is an arrangement drum that comprises the arrangement of the scalpet.

The drum of the arrangement of a modality can be separated.

The drum of the arrangement of a modality is disposable.

The adherent substrate of one embodiment is attached to the interior of the array drum.

The modalities described herein include a system comprising a scalpet arrangement comprising a plurality of scalpets fixed on a sleeve. The sheath is configured to be removably attached to and carried in a component of a Dermatome. The system includes an adherent substrate configured to be placed on the adjacent component of the sheath, where the adherent substrate is configured to capture skin pixels with extruded incisions through the scalpet arrangement as a result of applying a load to the arrangement of the scalpet.

The modalities described herein include a system comprising: a scalpet arrangement comprising a plurality of scalpets affixed to a sheath, wherein the sheath is configured to be removably coupled to and carried in a component of a Dermatome; and an adherent substrate configured to be placed on the adjacent component of the sheath, where the adherent substrate is configured to capture skin pixels with incisions extruded through the scalpet arrangement as a result of applying a load to the scalpet arrangement. .

The adhesive substrate of one embodiment is configured to be configured on the component between the sleeve and the component.

The Dermatome of a modality is a drum Dermatome, and the component is a drum.

The adherent substrate of a modality is placed between an outer surface of the drum and the sleeve, where the drum Dermatome is configured to apply the load via the scalpet arrangement.

The Dermatome of one modality includes a cutting member, where the cutting member transects the extruded skin inserts at the incisions through the scalpet arrangement.

The cutting member of an embodiment is internal to the drum.

The cutting member of an embodiment is external to the drum.

The Drum Dermatome of a modality is a Dermatome Padgett.

The drum of a modality is an arrangement drum that comprises the arrangement of the scalpet.

The drum of the arrangement of a modality can be separated.

The drum of the arrangement of a modality is disposable.

The adherent substrate of one embodiment is attached to the interior of the array drum.

The cover of a modality is disposable.

The modalities described herein include a system comprising a scalpet arrangement comprising a plurality of scalpets fixed on a sleeve. The sheath is configured to be removably attached to and carried in a component of a Dermatome. The system includes an adherent substrate, where the adherent substrate is configured to be removably coupled to and carried over the component, where the adherent substrate is configured to capture skin pixels generated by application of the scalpet arrangement to a surface of the skin.

The modalities described herein include a system comprising: a scalpet arrangement comprising a plurality of scalpets affixed to a sheath, wherein the sheath is configured to be removably coupled to and carried in a component of a Dermatome; and an adherent substrate, wherein the adherent substrate is configured to be removably coupled to and carried on the component, where the adherent substrate is configured to capture skin pixels generated by application of the scalpet arrangement to a skin surface.

The Dermatome of a modality is a drum Dermatome, and the component is a drum.

The Drum Dermatome of a modality is configured to apply via load the scalpet arrangement a load on the surface of the underlying skin of the scalpet arrangement.

The one mode adherent substrate is used in place of the scalpet arrangement and is configured to capture skin inserts in the incisions resulting from the application of the load.

The adherent substrate of one embodiment is placed on an outer surface of the drum.

The drum Dermatome of one embodiment includes a cutting member, wherein the cutting member transects the skin inserts into the incisions.

The cutting member of an embodiment is internal to the drum.

The cutting member of an embodiment is external to the drum.

The Drum Dermatome of a modality is a Dermatome Padgett.

The drum of a modality is an arrangement drum that comprises the arrangement of the scalpet.

The drum of the arrangement of a modality can be separated.

The drum of the arrangement of a modality is disposable.

The adherent substrate of one embodiment is attached to the interior of the array drum.

The one-mode system comprises a template plate configured for application to a skin surface.

The template plate of one embodiment is a perforated plate comprising a first perforation pattern.

The plurality of scalpets of one embodiment comprises a second pattern on the sheath.

The second pattern in a modality matches the first pattern.

The sleeve of one embodiment is configured to be applied to the template plate in a manner that results in matching the plurality of scalpets to the perforations in the template plate.

The cover of a modality is disposable.

Unless the context clearly requires otherwise, throughout the description, the words comprise, comprising, and the like will be constructed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is, in a sense of including, but not limited to. Words that use a singular or plural number also include the plural or singular number respectively. Additionally, the words herein below, top down and words with similar meanings, when used in this application, refer to this application as a whole and not to any particular portion of this application. When the word o is used with reference to a list of two or more articles, that word covers all of the following interpretations of the word; any of the items on the list, all the items on the list, and any combination of the items on the list.

The foregoing description of the modalities is not intended to be exhaustive or limited to systems and methods for the precise forms described. Although specific modalities, and examples of medical devices and methods are described herein for illustrative purposes, several equivalent modifications are possible within the scope of the systems and methods, as will be recognized by those skilled in the art. The medical device and method teachings provided herein can be applied to other systems and methods, not just the systems and methods described above.

The elements and actions of the various modalities described above can be combined to provide more modalities. These and other changes can be made to medical devices and methods in light of the detailed description above.

In general, in the following claims, the terms used should not be construed to limit medical devices and methods and systems and methods.

100 corresponding to the specific modalities described in the specification and claims, but should be constructed to include all systems operating under the claims. Accordingly, the medical devices and the corresponding methods and systems and methods are not limited by the description, but rather the scope will be fully determined by the claims.

Although certain aspects of medical medical devices and corresponding methods and systems and methods are set forth below in certain forms of claim, the inventors contemplate the various aspects of medical devices and methods and corresponding systems and methods in any number of claim forms. Accordingly, the inventors reserve the right to add any additional claims after filing the application to make such forms of

<td>claims</td><td colspan="2">additional</td><td>for</td><td>other aspects</td><td>of</td><td>the</td>

<td>devices and</td><td>methods</td><td colspan="2">medical</td><td>and systems and</td><td colspan="2">methods</td>

<td>corresponding.</td><td></td><td></td><td></td><td></td><td></td><td></td>

<td>It does</td><td>record</td><td>than,</td><td>with</td><td>relation to this</td><td>date,</td><td>the</td>

The best method known by the applicant for practicing said invention is the one that is clear from the present description of the invention.

101