Systems and methods for clinical soiling control on skin graft systems - Patents.com

Abstract

A system and method for controlling clinical soiling is provided. The system includes a device cover formed from a flexible polymer sheet defining an interior volume for a skin grafting device and including at least a first opening configured to receive a portion of the skin grafting device. The system further includes a band including a gasket secured to an outer periphery of the first opening of the device cover, the gasket configured to secure the device cover to the skin grafting device around the first opening and to inhibit infiltration of fluids into the interior volume of the device cover during a skin grafting process using the skin grafting device.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Patent Application No. 16 / 741,535, filed January 13, 2020, the disclosure of which is incorporated herein by reference for all purposes.

[0002] The subject matter disclosed herein relates generally to skin grafting systems, and more particularly to systems that may include devices for harvesting and implanting skin micro-columns. [Background technology]

[0003] An autograft can refer to tissue that is transplanted from one part of an individual's body (e.g., a "donor site") to another part (e.g., a "recipient site"). Autografts can be used, for example, to replace missing skin and other tissues and / or promote healing resulting from trauma, wounds, burns, surgery, and birth defects. The availability of tissue for autografting may be limited by characteristics of the candidate donor site, including the number and / or total area of ​​tissue grafts, the healing behavior of the donor site, the similarity of the donor and recipient sites, aesthetic considerations, etc.

[0004] Skin grafts can be performed surgically. For example, a conventional autograft procedure can include excising or surgically removing burn damaged tissue, selecting a donor site, which can be an area where healthy skin is removed to be used as a cover for the cleaned burn area, and harvesting the graft to remove from the donor site (e.g., using an instrument similar to an electric shaver). Such an instrument (e.g., a dermatome) can be configured to gently shave a thin piece of tissue (e.g., a split-thickness graft about 10 / 1000 inches thick) from the undamaged donor site skin to be used as a skin graft. The skin graft can then be placed on the cleaned wound and allowed to heal. The donor skin tissue can be removed to a depth such that the donor site can heal itself in a process similar to that of healing a second-degree burn.

[0005] Traditionally, sheet grafts and mesh grafts are two types of autografts that are often used for permanent wound coverage. Sheet grafts can refer to skin tissue pieces that are removed from undamaged donor sites on the body in a process that can be called harvesting. The size of the donor skin piece used can be approximately the same size as the damaged area. The sheet graft can be applied over the excised wound and stapled or otherwise fixed in place. The donor skin tissue used for sheet grafts cannot stretch much, and the sheet graft can often be a sheet graft that is slightly larger than the damaged area to be covered, since slight shrinkage of the graft tissue may occur after harvesting.

[0006] Sheet grafts can improve the appearance of repaired tissue sites. For example, sheet grafts may be used on large areas of the face, neck, and hands (if they are injured), allowing these more visible parts of the body to appear less scarred after healing. Sheet grafts can be used to cover entire burned or damaged areas of skin. Small areas of the sheet graft may be lost after placement, as accumulation of fluid (e.g., hematoma) may occur under the sheet graft after placement.

[0007] Mesh skin grafts can be used to cover larger areas of open wounds that may be difficult to cover using sheet grafts. Meshing the skin graft can facilitate the expansion of skin tissue from the donor site to cover a larger area. It can also facilitate the drainage of blood and fluids from under the skin grafts when they are placed on the wound, which can help prevent graft loss. The expansion ratio of the mesh graft (e.g., the ratio of the area of ​​the unstretched graft to the area of ​​the stretched graft) can typically be about 1:1 to about 1:4. For example, donor skin can be meshed at a ratio of about 1:1 or about 1:2, but a larger expansion ratio can result in a more fragile graft, which may result in scarring of the mesh graft as it heals, and / or longer healing times.

[0008] Traditional graft mesh methods can involve passing donor skin tissue through a machine that slits the tissue, which can facilitate expansion in a pattern similar to that of a fish net or chain link fence. Healing can occur as the spaces between the mesh of the stretched graft (which may be called interstices or gaps) are filled with new epithelial skin growth. However, mesh grafts may be less durable than sheet grafts, and large meshes can cause permanent scarring after the graft has healed.

[0009] As an alternative to autografts, skin tissue obtained from a recently deceased person (which may be referred to as homograft, allograft, or cadaver skin) can be used as a temporary cover for the cleansed wound area. Unmeshed cadaver skin can be placed over the excised wound and stapled in place. After surgery, the cadaver skin may be covered with a dressing. The wound coverage using the cadaver allograft can then be removed prior to permanent autografting.

[0010] Xenograft or heterograft may refer to skin harvested from one of a variety of animals, such as pigs. Xenograft skin tissue may also be used for temporary coverage of excised wounds prior to placement of a more permanent autograft, and may be used due to the limited availability and / or high cost of human skin tissue. In some cases, philosophical, economic or cultural opposition to the use of human cadaver skin may also be factors that lead to the use of xenografts. Wound coverage with xenografts or allografts is generally a temporary procedure that may be used until harvesting and placement of an autograft is possible.

[0011] Harvesting of graft tissue from a donor site can generally cause undesirable large-scale tissue damage at the donor site. On the other hand, small areas of skin wounds adjacent to healthy tissue can be well tolerated and heal quickly. Such healing of small wounds can occur in techniques such as "fractional photothermolysis" or "fractional resurfacing," in which patterns of damage having small dimensions can be created in skin tissue. These exemplary techniques are described, for example, in U.S. Pat. No. 6,997,923. Small-scale damage patterns can heal quickly by regrowth of healthy tissue and can further provide desirable effects such as skin tightening without visible scars.

[0012] The mechanism of tissue grafting provides an opportunity for the grafting tool to be exposed to clinical "soil" from the patient (e.g., blood, tissue, hair, etc.). In split-thickness and full-thickness skin grafting procedures (both of which harvest tissue extending below the epidermis), localized damage to capillaries and / or blood vessels often leads to bleeding. The extent of bleeding can be influenced by patient factors such as, for example, anticoagulants.

[0013] Therefore, it would be advantageous to have additional systems and methods for protecting reusable clinical tools from clinical soiling without sacrificing the functionality of the skin sampling process. Summary of the Invention

[0014] According to some embodiments of the present disclosure, a skin grafting system is provided. The skin grafting system comprises a handheld device including a device housing with a drive system secured therein. The skin grafting system further comprises a cartridge having a plurality of hollow microneedles, the plurality of hollow microneedles being surrounded by a peripheral housing and configured to be manipulated by the handheld device to extend and retract during a skin grafting process. The skin grafting system further comprises an absorbent material disposed within the peripheral housing and surrounding the plurality of hollow microneedles, and a device cover formed from a flexible polymer sheet defining an interior volume of the handheld device. The device cover includes at least a first opening configured to accommodate the cartridge. The skin grafting system further comprises a strap. The strap includes a gasket secured to an outer periphery of the first opening of the device cover and configured to secure the device cover to at least one of the handheld device or the cartridge around the first opening to inhibit ingress of fluid into the interior volume of the device cover. Furthermore, the absorbent material is configured to inhibit ingress of fluid into the interior of the handheld device through the cartridge.

[0015] According to some embodiments of the present disclosure, a skin grafting system is provided. The system includes a handheld device having a device housing with a drive system secured therein. The system further includes a cartridge having a plurality of hollow microneedles, the plurality of hollow microneedles being surrounded by a peripheral housing and configured to be manipulated by the drive system to extend and retract during a skin grafting process. The system further includes a device cover, the device cover being formed from a flexible polymer sheet defining an interior volume of the handheld device and including at least a first opening configured to accommodate the cartridge. The system further includes a band, the band including a gasket, the gasket being secured to an outer periphery of the first opening of the device cover and configured to secure the device cover to at least one of the handheld device or the cartridge around the first opening to inhibit ingress of fluid into the interior volume of the device cover.

[0016] According to some embodiments of the present disclosure, a system for controlling clinical soiling is provided, the system comprising a device cover formed from a flexible polymer sheet defining an interior volume for a skin grafting device and including at least a first opening configured to receive a portion of the skin grafting device, the system further comprising a strap including a gasket secured to an outer periphery of the first opening of the device cover and configured to secure the device cover to the skin grafting device around the first opening to inhibit ingress of fluids into the interior volume of the device cover during a skin grafting process performed using the skin grafting device.

[0017] The following description and the annexed drawings set forth in detail certain exemplary embodiments of the present disclosure. These embodiments are indicative, however, of but a few of the various ways in which the principles of the present disclosure can be employed. Other embodiments and features will become apparent from the following detailed description of the present disclosure in conjunction with the drawings.

[0018] The following description is provided with reference to the accompanying drawings, in which like reference numerals indicate like elements and in which: [Brief description of the drawings]

[0019] [Figure 1] FIG. 1 illustrates a top perspective view of a skin grafting system including a cartridge according to some embodiments of the present disclosure. [Figure 2A] FIG. 2 is a front perspective view of the system of FIG. 1. [Figure 2B] 2B is a top view of a user interface that may be included in the system of FIG. 2A according to some embodiments of the present disclosure. [Figure 3A] 2B is a cutaway view of the handheld device of FIG. 2A according to some embodiments of the present disclosure. [Figure 3B] 2B is a cutaway view of a housing corresponding to the handheld device of FIG. 2A according to some embodiments of the present disclosure. [Figure 4A] FIG. 2B is a rear perspective view of an internal drive assembly and associated elements corresponding to the handheld device of FIG. 2A according to some embodiments of the present disclosure. [Figure 4B] FIG. 4B is a right perspective view of a left frame assembly corresponding to the inner assembly of FIG. 4A according to some embodiments of the present disclosure. [Figure 4C] FIG. 4B is a right perspective view of a right frame assembly corresponding to the inner assembly of FIG. 4A according to some embodiments of the present disclosure. [Figure 4D] FIG. 4B is a rear perspective view of a horizontal component assembly corresponding to the inner assembly of FIG. 4A according to some embodiments of the present disclosure. [Figure 4E] FIG. 4B is a rear perspective view of a vertical component assembly corresponding to the inner assembly of FIG. 4A according to some embodiments of the present disclosure. [Figure 5A] FIG. 13 is a perspective view of a cartridge assembly including a removable cover according to some embodiments of the present disclosure. [Figure 5B] FIG. 5B is a perspective view of a cartridge corresponding to the cartridge of FIG. 5A according to some embodiments of the present disclosure. [Figure 6A] 1 is an example of a microneedle and pin assembly capable of harvesting tissue according to some embodiments of the present disclosure. [Figure 6B] FIG. 1 is a perspective view of a microneedle and pin assembly capable of harvesting tissue according to some embodiments of the present disclosure. [Figure 6C] FIG. 1 is a plan view of a microneedle array according to some embodiments of the present disclosure. [Figure 7] 1 is a procedural flow chart illustrating a method for harvesting and implanting tissue according to some embodiments of the present disclosure. [Figure 8A] FIG. 1 is a perspective view of a clinical soil control system according to some embodiments of the present disclosure. [Figure 8B] FIG. 8B is a side view of the clinical soil control system of FIG. 8A according to some embodiments of the present disclosure. [Figure 9A] FIG. 1 is a perspective view of an apparatus cover corresponding to a clinical soiling control system according to some embodiments of the present disclosure. [Figure 9B] FIG. 9B is a top view of the device cover of FIG. 9A according to some embodiments of the present disclosure. [Figure 10] FIG. 1 is an exploded view of a gasket assembly corresponding to a clinical soiling control system according to some embodiments of the present disclosure. [Figure 11A] FIG. 13 is a front view of a lower portion of a gasket case corresponding to a gasket enclosure according to some embodiments of the present disclosure. [Figure 11B] FIG. 11B is a rear view of the gasket case lower portion of FIG. 11A according to some embodiments of the present disclosure. [Figure 11C] FIG. 11B is a side view of the lower part of the gasket case of FIG. 11A according to some embodiments of the present disclosure. [Figure 12A] FIG. 2 is a front view of a gasket according to some embodiments of the present disclosure. [Figure 12B] FIG. 12B is a side view of the gasket of FIG. 12A according to some embodiments of the present disclosure. [Figure 13A]FIG. 13 is a rear view of a gasket case top corresponding to a gasket enclosure according to some embodiments of the present disclosure. [Figure 13B] FIG. 13B is a side view of the top of the gasket case of FIG. 13A according to some embodiments of the present disclosure. [Figure 14A] FIG. 13 is a front perspective view of a gasket according to another embodiment of the present disclosure. [Figure 14B] FIG. 14B is a rear perspective view of the gasket of FIG. 14A according to some embodiments of the present disclosure. [Figure 14C] FIG. 14B is a front view of the gasket of FIG. 14A according to some embodiments of the present disclosure. [Figure 14D] FIG. 14B is a rear view of the gasket of FIG. 14A according to some embodiments of the present disclosure. [Figure 14E] FIG. 14B is a side view of the gasket of FIG. 14A according to some embodiments of the present disclosure. [Figure 15A] 1A-1D are top views of absorbent materials compatible with clinical soil control systems, according to some embodiments of the present disclosure. [Figure 15B] FIG. 15B is a top view of the absorbent material of FIG. 15A disposed within a tissue stabilizer, according to some embodiments of the present disclosure. [Figure 15C] FIG. 15B is a perspective view of the absorbent material of FIG. 15A disposed around a microneedle array according to some embodiments of the present disclosure. [Figure 16A] FIG. 1 is a side view of a clinical soil control system according to some embodiments of the present disclosure. [Figure 16B] FIG. 16B is a side view of the applied clinical soil control system of FIG. 16A according to some embodiments of the present disclosure. [Figure 16C] FIG. 16B is a front perspective view of the applied clinical soil control system of FIG. 16A according to some embodiments of the present disclosure. [Figure 16D] FIG. 16B is a side perspective view of the applied clinical soil control system of FIG. 16A according to some embodiments of the present disclosure. [Figure 16E]FIG. 16B is a perspective view illustrating a user engaging with the applied clinical soil control system of FIG. 16A according to some embodiments of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] The following discussion is presented to enable those skilled in the art to make and use the disclosed systems and methods. Various modifications to the illustrated embodiments will be readily apparent to those skilled in the art, and the high level principles of the present disclosure may be applied to other embodiments and applications without departing from the disclosed embodiments. Thus, the disclosed embodiments are not intended to be limited to the embodiments shown, but are to be accorded the widest scope consistent with the principles and features disclosed herein.

[0021] The detailed description should be read with reference to the drawings. The drawings depict selected embodiments and are not intended to limit the scope of the embodiments of the present disclosure. Those skilled in the art will recognize that the examples provided herein have many useful alternatives and are within the scope of the embodiments of the present disclosure. It should also be understood that the expressions and terms used herein are for the purpose of description and should not be considered as limiting. In this specification, "including," "comprising," or "having" and variations thereof mean to include the items listed thereafter and their equivalents as well as additional items.

[0022] Unless otherwise specified or limited, the terms "attached," "connected," "supported," and "coupled," and variations thereof, are used broadly and include direct and indirect attachments, connections, supports, and couplings. Furthermore, "connected" and "coupled" are not limited to physical or mechanical connections or couplings. As used herein, unless otherwise specified, "connected" means that one element / feature is directly or indirectly connected to another element / feature, but not necessarily electrically or mechanically connected. Similarly, unless otherwise specified, "coupled" means that one element / feature is directly or indirectly connected to another element / feature, but not necessarily electrically or mechanically coupled.

[0023] Embodiments of the present disclosure may be described herein in terms of functional and / or logical block components and various processing steps. Of course, such block components may be realized by any number of hardware, software, and / or firmware components configured to perform a particular function. For example, an embodiment may use various integrated circuit components, such as digital signal processing elements, logic elements, diodes, etc., which may perform various functions under the control of one or more processors or other controllers. Other embodiments may use program code, or code in combination with other circuit components.

[0024] As mentioned above, the present disclosure relates generally to a skin grafting system, and more particularly to a system including an apparatus for harvesting and implanting skin micro-columns. In some circumstances, the process of harvesting a skin micro-column may include piercing donor site tissue. Harvesting a micro-column often causes localized bleeding, although this is usually minimal. The amount of blood from the donor site may depend on various factors, such as, for example, the number of tissue punctures / piercings, the number of harvesting processes performed on a single tissue area, the number of harvesting processes performed with a single cartridge (as described below), the patient's blood pressure, platelet count, medication, donor site treatment, and / or co-morbidities. In some circumstances, it may be advantageous to prevent blood from contacting and / or entering parts of the skin grafting system. In particular, it may be advantageous to prevent blood from entering reusable elements of the skin grafting system.

[0025] As an example, medical facilities often have standard cleaning, disinfection and / or sterilization procedures that must be performed when instruments are reusable between patients. Specifically, to minimize the risk of infection spread, all blood and bodily material should be treated as potentially infectious. With complex instruments, ingress of blood into the instrument housing can result in, among other things, delays in the procedure, lengthy sterilization processes and / or instrument replacement (and associated costs). Accordingly, the present disclosure includes a system for preventing blood ingress into a handheld device (e.g., a reusable handheld device) that corresponds to a skin grafting system. A system for preventing blood / fluid ingress into a skin grafting system is further described in U.S. Patent Application Serial No. 16 / 592,312, entitled "System and Method for Fluid Ingress Control for a Skin Grafting System," filed October 3, 2019, the disclosure of which is incorporated herein by reference in its entirety.

[0026] In some embodiments, a system for preventing blood or fluid ingress into a skin graft system can include a cincture. As used herein, the term cincture is defined as an element that partially or fully encases (e.g., forms a seal that joins or separates components). Additionally, as used herein, the term seal is defined as the junction between elements, which creates a barrier that helps prevent fluid ingress.

[0027] 1, a skin grafting system 3000 according to some embodiments of the present disclosure is shown. In some configurations, the skin grafting system 3000 can be configured to harvest and implant donor tissue. As shown, the skin grafting system 3000 can include a handheld device 1000 (which may be reusable) and a cartridge assembly 2000. As described in more detail below, the cartridge assembly 2000 can include a cartridge 2002 and a cartridge cover 2004. In some configurations, the cartridge 2002 can include a microneedle and pin array 2006. In particular, the cartridge 2002 can include a simplified microneedle array 2006 (i.e., does not include pins).

[0028] As shown in FIGS. 1-2B, the handheld device 1000 can include an engagement slot 1002 configured to receive a cartridge assembly 2000. A loading door 1004 can move between an "open" position (see, e.g., FIG. 1) and a "closed" position (see, e.g., FIGS. 2A-2B). In some configurations, the loading door 1004 can be hinged and further configured to open and close over a loading opening 1006. The handheld device 1000 can include a door sensor, which can determine the position of the loading door 1004. The loading opening 1006 can be sized to allow the cartridge assembly 2000 to slide in and out of the engagement slot 1002 as desired by a user. Advantageously, the cartridge assembly 2000 can be single use and / or disposable (e.g., including multiple uses for a single patient), while the handheld device 1000 can be designed to be multi-use. 2A, the handheld device 1000 may further include a trigger 1014. The trigger 1014 may be configured to initiate the harvesting and / or planting process in response to a selection and / or trigger input by a user via the user interface 1008. In some configurations, the handheld device 1000 may include an indicator light 1016. The indicator light 1016 may be positioned such that the user can easily view the indicator light 1016 during harvesting and / or planting.

[0029] In some configurations, the handheld device 1000 may include a user interface 1008. As shown, the user interface 1008 may include a standby input 1018, an indicator light 1020, and / or an implantation input 1022. In some configurations, the indicator light 1020 may operate the same as or similar to the indicator light 1016 (described above). The standby input 1018, the indicator lights 1016, 1020, and the implantation input 1022 may provide visual feedback to the user corresponding to the current operation of the skin grafting system 3000 as the skin grafting system 3000 is used in accordance with the skin grafting process described below.

[0030] 3A-3B, cutaway views of a handheld device 1000 in accordance with configurations of the present disclosure are shown. The handheld device 1000 is shown to include various internal controllers. In some configurations, the handheld device 1000 may include a power module 1028, a solenoid controller 1030, and / or a main controller 1032. The power module 1028 may be in electrical communication with a power input 1038. In some configurations, the drive system 1034 may include a solenoid in communication with the solenoid controller 1030.

[0031] 3A-3B, in some configurations, the handheld device 1000 can include a housing 1036. The housing 1036 can include a left enclosure half and a right enclosure half. In some configurations, the left enclosure half, the right enclosure half, the loading door 1004, and the enclosure mounting cover can each be injection molded separately. The left enclosure half and the right enclosure half can be constructed of a hard plastic substrate, and in some configurations, can be constructed of softer elastomeric overmolded sections. Similarly, the loading door 1004 and the enclosure mounting cover can be constructed of a hard plastic substrate. In some configurations, the interior of the housing 1036 can interface with an internal subassembly. As an example, ribs can be secured to the interior of the housing 1036 and can be configured to support various printed circuit boards (PCBs). The ribs can separate the PCBs (e.g., power module 1028, solenoid controller 1030, and main controller 1032) from the internal moving components. Additionally, in some configurations, the housing 1036 can support the internal subassembly 1034 via pins and vibration damping boots. This can dampen the movement of the internal subassembly 1034 (e.g., from a user, from the internal moving components) and can protect the internal subassembly 1034 from damage due to external shocks (e.g., from dropping the handheld device 1000).

[0032] 4A-4E, various internal assemblies corresponding to the handheld device 1000 are shown according to several configurations. FIG. 4A shows an internal subassembly 1034 that may include a left frame assembly 1040a, a right frame assembly 1040b, a horizontal component assembly 1044, and / or a vertical component assembly 1046. Each of the left and right frame assemblies 1040a, 1040b may include a corresponding flipper assembly (e.g., left flipper assembly 1048a, right flipper assembly 1048b). In some configurations, the horizontal component assembly 1044 may include a horizontal motor 1050. Additionally, the vertical component assembly 1046 may include a solenoid 1052.

[0033] 4A-4E, and in particular, 4B and 4C, further exemplary details of the left and right frame assemblies 1040a, 1040b according to some configurations are shown. In some configurations, the left frame assembly 1040a and the right frame assembly 1040b can be identical or substantially similar (e.g., symmetrical). As shown, the left frame assembly 1040a can include a left flipper assembly 1048a secured to a first side of the left frame. The left frame assembly 1040a can also include flag sensors 1060a, 1060b secured to a second side of the left frame. The flag sensors 1060a, 1060b can communicate with a position sensing linear slide 1054 and a position sensing flag 1062. In some configurations, the left frame assembly 1040a can include position sensing springs 1056a, 1056b, which can contact a tissue interface 1058a. The tissue interface 1058a can be located on a third side of the left frame. In some configurations, the left frame assembly 1040a can be attached to a portion of the vertical component assembly 1046 via screws and alignment pins, or other attachment system.

[0034] In some configurations, the right frame assembly 1040b may include flag sensors 1060c, 1060d secured to a first side of the right frame. The flag sensors 1060c, 1060d may communicate with the position sensing linear slide 1054 and the position sensing flag 1062. Additionally, as shown, the right frame assembly 1040b may include a right flipper assembly 1048b secured to a second side of the right frame. In some configurations, the right frame assembly 1040b may include position sensing springs 1056c, 1056d, which may contact the tissue interface 1058b. The tissue interface 1058b may be located on a third side of the right frame. In some configurations, the right frame assembly 1040b may be attached to a portion of the vertical component assembly 1046 via a screw and an alignment pin.

[0035] The flipper assembly 1048a, 1048b can include a flipper mounting block 1066 and a flipper motor 1068. In some configurations, the flipper mounting block 1066 can be constructed from a dielectric material. The flipper motor 1068 can be connected to (and control) the flipper driver pulleys 1070a, 1070b. A bearing (e.g., thrust bearing) 1072 can support an axial load applied by a needle top plate (e.g., needle top plate 1112, as described below) on the flipper 1074. The flipper 1074 can rotate in response to motor actuation, and the flipper driver pulleys 1070a, 1070b can prevent any downward movement of the flipper 1074 during operation of the handheld device 1000. In some configurations, the flipper 1074 can include two connected components, such as two brass components brazed together. The primary function of the flipper 1074 may be to hold the needle top plate 1112 of FIG. 4E in place when loading the needle retraction spring, and the flipper 1074 can move out of the way of the needle top plate 1112 during the remainder of normal operation. In some configurations, the flipper mounting block 1066 can act as a guide (e.g., to maintain proper alignment) for the solenoid plunger bar 1106 of FIG. 4E.

[0036] 4A-4E, and in particular FIG. 4D, further exemplary details of the horizontal component assembly 1044 according to some configurations are shown. The horizontal component assembly can include sensors, actuators, and / or guides for positioning the horizontal carriage assembly 1082, and thus hammers 1098a, 1098b (described below) used to move the microneedles into the tissue. In some configurations, the horizontal flag sensor 1064 can be used to position the horizontal component assembly 1082. As shown, the horizontal component assembly 1044 can include a horizontal carriage assembly 1082 that can be configured to mount a horizontal motor 1050. In some configurations, the horizontal chassis 1084 can support the horizontal carriage assembly 1082. Additionally, the right frame assembly 1040b and the left frame assembly 1040a can be secured to opposing sides of the horizontal chassis 1084, for example, using rivets. According to some configurations, the ground connection 1080 can be attached to the horizontal chassis 1084.

[0037] In some configurations, the horizontal component assembly 1044 may further include a retractable sliding door 1090. When a cartridge 2002 is not inserted into the engagement slot 1002, the sliding door 1090 may extend across the loading opening 1006. Thus, a user may be prevented from placing anything in the handheld device 1000 in the absence of the cartridge 2002. The sliding door 1090 may be secured to a sliding door mounting portion 1086, which may be secured to the horizontal chassis 1084. Additionally, a sliding door spring 1088 may be secured to the sliding door mounting portion 1086 and biased to maintain the sliding door 1090 in a "closed" position (i.e., extending across the loading opening 1006) when a cartridge is not loaded.

[0038] As shown, the horizontal carriage assembly 1082 may include, in some configurations, hammers 1098a, 1098b, corresponding hammer return springs 1092a, 1092b, and corresponding hammer guides 1094a, 1094b. In general, the horizontal carriage assembly 1082 may be configured to position and guide the hammers 1098a, 1098b to move the microneedles into the tissue. In some configurations, the hammer guides 1094a, 1094b may be made of bronze, which may help maintain a bearing surface through multiple harvesting and implanting cycles. Additionally, in some configurations, the hammers 1098a, 1098b may be hardened 17-4 stainless steel, which may provide excellent wear characteristics while remaining corrosion resistant. Alternatively, the hammers 1098a, 1098b may be another bearing material. The horizontal carriage assembly 1082 may further include a horizontal lead screw drive nut 1096. In addition, the horizontal leadscrew assembly 1096 can be a Teflon coated leadscrew and an acetal drive nut designed to reduce friction. Alternatively, the horizontal leadscrew drive assembly 1096 can include other types of materials. The horizontal leadscrew drive assembly 1096 can provide the appropriate pitch to position resolution and linear force. Additionally, the horizontal carriage assembly 1082 can use motor stall to sense whether a cartridge is loaded or if there is a device jam.

[0039] 4A-4E, and in particular FIG. 4E, further exemplary details of the vertical component assembly 1046 according to some configurations are shown. As shown, the vertical component assembly 1046 may include a solenoid 1052 and a corresponding solenoid plunger bar 1106. Additionally, the vertical component assembly 1046 may include a vertical motor 1100 and associated unlocking cams 1102a, 1102b and vertical lead screws 1104a, 1104b. In some configurations, the vertical position of the vertical carriage subassembly 1108 may be controlled by moving it up and down on the vertical lead screws 1104a, 1104b (e.g., using the vertical motor 1100). As described below, the vertical positioning may move each of the microneedles corresponding to the cartridge 2002. In general, the vertical component assembly 1046 may be configured to interface with and operate the cartridge 2002 and its associated components during tissue harvesting and / or implantation. In some configurations, the vertical motor 1100 can be sized to fit within the vertical component assembly 1046 while providing the torque and speed required to manipulate the microneedle position.

[0040] In some configurations, the solenoid 1052 can deliver an actuation force to the hammers 1098a, 1098b during collection. As one non-limiting example, the solenoid 1052 can be actuated by a half wave of AC current. The force delivered by the solenoid 1052 can increase sharply toward the end of its stroke. In some configurations, the mass of the solenoid plunger bar 1106 and the solenoid plunger can be selected based on the energy required to move the microneedle into the tissue. In some configurations, a stop (e.g., a brass stop) can be incorporated into the solenoid 1052, which can allow for controlled extension of the solenoid plunger bar 1106 and absorption of remaining kinetic energy at the end of the stroke.

[0041] In some configurations, the vertical component assembly 1046 can include a vertical carriage assembly 1108. As shown, the vertical carriage assembly 1108 can include a needle retraction slide 1110 with a top plate 1112. In some configurations, opposing ends of the vertical carriage assembly 1108 can include needle retraction slide latches 1116a, 1116b with corresponding latch plates 1122a, 1122b. The latch plates 1122a, 1122b can define a maximum position of the needle retraction slide 1110. In addition, a needle retraction spring 1120 can be incorporated into the vertical carriage assembly 1108, thereby achieving efficient retraction of the microneedle on the pin. The needle retraction slide latches 1116a, 1116b can be used to lock the needle retraction slide 1110 downward in preparation for collection. The vertical carriage assembly 1108 can also move both the needle and the pin (e.g., the pin in the microneedle) simultaneously.

[0042] In some configurations, the vertical carriage assembly 1108 can include a cartridge latch 1114 that can be configured to secure the cartridge 2002 when the cartridge 2002 is inserted into the loading opening 1006. Additionally, in some configurations, a vertical flag 1118 can be secured to the exterior of the vertical carriage assembly 1108. As shown, the needle retraction slide 1110 can further include guide posts 1124a, 1124b that can be configured to guide the needle retraction slide 1110 during vertical movement. In some configurations, the needle retraction slide 1110 can include a lockdown latch 1126 that can contact the guide posts 1124a, 1124b and is configured to engage and disengage the microneedle during operation of the handheld device 1000. The needle retraction slide 1110 can be a spring-loaded subassembly that serves at least two purposes. First, the slide 1110 can lock the needle module down (after it has been moved into the tissue). Second, the slide 1110 can retract the needle. In some configurations, the needle retraction slide 1110 can only retract the needle and cannot move the needle forward. Additionally, in some configurations, the lockdown latch 1126 may be configured to operate only after the skin grafting system 3000 has gone through initialization. Further details regarding the operation of the skin grafting system 3000 are provided below.

[0043] 5A-5B, a cartridge 2002 and cartridge assembly 2000 according to several configurations are shown. As shown, the cartridge assembly 2000 can include a cartridge 2002 and a cartridge cover 2004 that can be removably secured to a microneedle chamber 2018. The microneedle chamber 2018 can enclose a plurality of microneedles 2006. In some configurations, the microneedles 2006 can be arranged as an array within the microneedle chamber 2018. As shown in FIG. 5A, the combination of the cartridge cover 2004 and the microneedle chamber 2018 can form an enclosure for the microneedles 2006. The cartridge cover 2004 can include release levers 2016a, 2016b that can be simultaneously pressed by a user to remove the cartridge cover 2004 from the cartridge 2002. In some embodiments, the cartridge cover 2004 can lock onto the cartridge arm 2020 when the microneedles are in a particular position. The cartridge arm 2020 can prevent movement of the microneedles when the cartridge cover 2004 is secured to the cartridge 2002.

[0044] In some configurations, the cartridge 2002 can include a tissue stabilizer 2014 that forms a peripheral housing 2017 and can be configured to stabilize the tissue during harvesting. That is, the tissue stabilizer 2014 forms a peripheral housing 2017 that is wider than the microneedle chamber 2018, thereby allowing for greater force distribution during use of the skin grafting system 3000 on the tissue. As shown, the tissue stabilizer 2014 can further include outwardly extending loading tabs 2012a, 2012b. In some configurations, the loading tabs 2012a, 2012b can slide into contact with the engagement slots 1002 during loading of the cartridge assembly 2000 into the loading opening 1006.

[0045] 6A-6C, a microneedle 2050 and a microneedle array 2006 are shown in accordance with configurations of the present disclosure. The microneedle 2050 can facilitate the harvesting of tissue from a donor site. In some configurations, the microneedle 2050 can include a hollow tube 2054, which can include a plurality of tips 2056 at its distal end. In some non-limiting examples, needle systems such as those described in U.S. Pat. Nos. 9,060,803, 9,827,006, 9,895,162, and U.S. Patent Application Nos. 2015 / 0216545, 2016 / 0015416, 2018 / 0036029, and 2018 / 0140316, and / or combinations or components thereof, can be used.

[0046] In some configurations of the present disclosure, the hollow tube 2054 can include two tips 2056 that are angled sufficiently to penetrate and cut through biological tissue to remove small micro-implants therefrom. Such a hollow tube 2054 can be provided with two tips 2056 and a "narrow heel" portion disposed between the two tips 2056. In some embodiments, the narrow heel portion can be sharpened such that a corresponding cutting edge is created in the hollow tube 2054.

[0047] 6A, the hollow tube 2054 may be slidably mounted to the substrate 2058 such that the hollow tube 2054 can pass through a hole in the substrate 2058. The position of the hollow tube 2054 relative to the substrate 2058 can be controlled by translating the hollow tube 2054 relative to the substrate 2058, for example, substantially along a longitudinal axis of the hollow tube 2054. In this manner, the distance that the distal end of the hollow tube 2054 protrudes past the underside of the substrate 2058 can be controllably varied.

[0048] The microneedle 2050 can further include a pin 2052 disposed in a central lumen or opening of the hollow tube 2054. The diameter of the pin 2052 can be substantially the same as or slightly smaller than the inner diameter of the hollow tube 2054, thereby allowing the hollow tube 2054 to translate along an axis corresponding to the pin 2052 with the pin 2052 filling or occluding most or all of the internal lumen of the hollow tube 2054. The pin 2052 can be formed of a low friction material or coated with a low friction material, such as, for example, Teflon, to facilitate movement of the hollow tube 2054 relative to the pin 2052 and / or inhibit accumulation or adhesion of biological material to the pin 2052. The distal end of the pin 2052 can be substantially flat, configured to facilitate displacement of the tissue micro-implant within the hollow tube 2054 as the hollow tube 2054 is translated relative to the pin 2052.

[0049] The hollow tube 2054 may be translated relative to the pin 2052, for example, substantially along the longitudinal axis of the hollow tube 2054. In this manner, the position of the distal end of the hollow tube 2054 relative to the position of the distal end of the pin 2052 can be controllably varied. For example, the positions of the distal ends of both the hollow tube 2054 and the pin 2052 relative to the position of the underside of the substrate 2058 can be controllably and independently selected and varied.

[0050] 6B illustrates one configuration of the present disclosure in which the pins 2052 may be positioned such that their distal ends are substantially aligned with respect to the hollow tube 2054. In another configuration, the pins 2052 may extend slightly beyond the distal end of the hollow tube 2054, thereby protecting sharp portions of the hollow tube 2054 from unwanted contact with objects and / or the user. The pins 2052 and / or portions of the hollow tube 2054 may optionally be coated or surface treated to reduce friction between them and / or between any components or biological tissue.

[0051] As described herein, a plurality of microneedles (e.g., microneedle 2050) can form a microneedle array 2006. FIG. 6C shows a top view of an exemplary microneedle array 2006 according to configurations of the present disclosure. In some configurations, the microneedle array 2006 can be generally circular. The microneedle array 2006 can be formed by assembling multiple rows of needles (horizontal rows or vertical rows). The design can be modular, and the configuration can be any shape or size with rows of various sizes as modules. In some configurations, all of the microneedles can be actuated (e.g., inserted into tissue) simultaneously. In other configurations, groups or sections can be actuated in sequence. For example, the microneedle array 2006 can be divided into quadrants and each quadrant can be actuated in sequence. Sequential can refer to actuating each row in a linear order (e.g., row 1, row 2, row 3) or non-linearly (e.g., row 1, row 10, row 3). Alternatively, each row of microneedles may be actuated separately and in sequence. Additionally, each single microneedle may be actuated separately and in sequence. In some configurations, one row may be actuated at a time, e.g., 20 rows may be actuated individually in sequence, while in other configurations, two, three, four or more rows may be actuated at a time. An advantage of actuating segments of the microneedle array 2006 in sequence is that inserting a segment requires less force on the donor site than inserting the entire microneedle array 2006. In some configurations, the microneedle array 2006 may be actuated using a solenoid (e.g., solenoid 1052). Multiple actuations using solenoids allow for sequencing of insertion by row.

[0052] 7, several non-limiting examples of steps of a process 4000 for harvesting and implanting tissue according to configurations of the present disclosure are shown. In some configurations, the process 4000 can be performed using the skin grafting system 3000, as described above. As shown, the process 4000 includes powering a handheld device (process block 4002). In some configurations, the handheld device can be the same as or similar to the handheld device 1000. The process 4000 is further shown to include loading a cartridge into the handheld device (process block 4004). In some configurations, the cartridge can be the same as or similar to the cartridge 2002 or cartridge assembly 2000. Additionally, the process 4000 is shown to include activating a harvesting mode (process block 4006). This activation can be initiated via the user interface 1008 according to some configurations as described below. Alternatively, activation can be initiated via contact with a donor site. Process 4000 is shown to include applying a skin graft system (e.g., skin graft system 3000) to a donor site (process block 4008). The donor site can correspond to a healthy area of ​​tissue of the patient. Process 4000 is then shown to include initiating a harvesting process (process block 4010). In some configurations, this initiation can occur via trigger 1014, discussed above. Process 4000 is then shown to further include removing the skin graft system from the donor site (process block 4012). Process 4000 is then shown to include activating an implantation mode (process block 4014). In some configurations, this initiation can occur via user interface 1008, as described below. Process 4000 is further shown to include positioning the skin graft system over a recipient site (process block 4016). In some configurations, the recipient site can correspond to a damaged area of ​​tissue of the patient.Next, the process 4000 is shown to include initiating the implantation process (process block 4018). In some configurations, this initiation may occur via activation of the trigger 1014 described above. As shown, the process 4000 may end after the implantation process (process block 4018) or may return to process block 4006 to reinitiate the harvest mode. In some configurations, a single cartridge (e.g., cartridge 2002) may be used multiple times on the same patient. Advantageously, if the recipient site is relatively large, multiple harvests and implants may be performed using a single cartridge. Thus, the process 4000 may continue from process block 4006 to process block 4018 until the user is ready to discard the cartridge.

[0053] In accordance with the configurations of the present disclosure, the harvesting and implantation processes can be performed using the skin grafting system 3000. Thus, a non-limiting description of the internal functions of the handheld device 1000 and cartridge 2002 is disclosed herein.

[0054] <User Interface> Referring to FIG. 2B, as one non-limiting example, an example of using the user interface 1008 to control the above process is provided. When the handheld device is powered, the standby input 1018 may flash green when the handheld device 1000 is first turned on (e.g., for about 8 seconds on initial start-up). This may inform the user that the handheld device 1000 is performing a start-up self-test or other operation. As another non-limiting example, the standby input 1018 may generate a steady green illumination when the handheld device 1000 is on and ready for further use. In some configurations, pressing the standby input 1018 for a predetermined amount of time (e.g., 3 seconds, 5 seconds, etc.) may cause the handheld device 1000 to enter a standby mode. Continuing with the non-limiting example, the standby input 1018 may stop generating light when the handheld device 1000 is in standby mode. Other light colors, patterns and timing may be incorporated according to various configurations and preferences.

[0055] As another non-limiting example, the indicator light 1020 can generate a steady white light when the handheld device 1000 is in harvest mode but sufficient pressure on the donor site has not been achieved during the skin grafting process as described below. Additionally, the indicator light 1020 can generate a steady green light when the handheld device 1000 is in harvest mode and sufficient pressure on the donor site has been achieved (and the trigger 1014 is disengaged). The indicator light 1020 can generate a flashing green light when the handheld device 1000 is in the harvest process. When the pressure falls below a threshold during the harvest process, the indicator light 1020 can generate a flashing white light. Additionally, the indicator light 1020 can generate a flashing white light when the handheld device 1000 is in a fault state.

[0056] In another non-limiting example, the planting input 1022 can generate a steady white light when the harvesting process is complete. In some configurations, a subsequent press of the planting input 1022 can cause the handheld device 1000 to enter a planting mode. The planting input 1022 can generate a steady green light when the handheld device 1000 is in a planting mode. Similar to the indicator light 1020, the planting input 1022 can generate a flashing white light when the handheld device 1000 is in a fault state. In some configurations, the planting input 1022 can generate a flashing white light during the harvesting process, which may indicate that an extraction recovery is required. A subsequent press of the planting input 1022 can initiate an extraction recovery process. Once the extraction recovery process is complete, the planting input 1022 can generate a steady white light. A detailed description of the extraction recovery process is provided below.

[0057] In some configurations, when the handheld device 1000 is in collection mode and sufficient pressure on the donor site is achieved (and the trigger 1014 is disengaged), an indicator light 1016, similar to the indicator light 1020, can generate a solid green light. Additionally, in some configurations, the indicator light 1020 can generate a flashing green light during the collection process.

[0058] <Skin graft system operating position> In some configurations, multiple operating positions may be defined for the skin grafting system 3000. In particular, the skin grafting system 3000 may operate using additional operating positions that are not explicitly defined.

[0059] Some configurations of the present disclosure include a horizontal carriage home position in which the horizontal carriage assembly 1082 can be positioned to block the horizontal flag sensor 1064. This position can be a "safe" position that keeps the carriage away from other moving parts.

[0060] Some configurations of the present disclosure include a vertical carriage home position, which corresponds to a calibrated position where the vertical carriage assembly 1108 may be aligned with a corresponding component for loading or harvesting. This position may be below the vertical flag sensor occlusion point. From the user's perspective, the vertical carriage assembly 1108 may appear to be closest to the engagement slot 1002 of the handheld device 1000.

[0061] Some configurations of the present disclosure include a vertical carriage unlock / plant position that corresponds to a calibrated position in which the needle retract slide 1110 is unlocked by the vertical carriage assembly 1108 by pushing the needle retract slide latches 1116a, 1116b above the respective unlocking cams 1102a, 1102b. This may be the highest position that the vertical carriage assembly 1108 travels to. From the user's perspective, the vertical carriage assembly 1108 may appear to be up inside the handheld device 1000.

[0062] Some configurations of the present disclosure include a "flipper in" position and a "flipper out" position. Each flipper 1074 can have two defined positions that are detected by the handheld device 1000 via a flag sensor that can provide positive feedback that each position has been reached. The "flipper in" or retracted position can correspond to when the flipper 1074 is safely away from the moving parts. The "flipper out" or extended position can correspond to when the flipper 1074 is blocking the top plate 1112. The "flipper out" position may be used for initialization when the needle retraction slide 1110 (and thus the cartridge 2002) is locked.

[0063] Some configurations of the present disclosure include a vertical carriage lock position, which corresponds to a calibrated position in which the vertical carriage assembly 1108 can be moved (with the flipper 1074 extended outward) to compress the needle retraction spring 1120 and lock the needle retraction slide latch 1116. This "lock" locks the cartridge 2002 within the handheld device 1000 while allowing the needle to be retracted at a later time.

[0064] Some configurations of the present disclosure include a vertical carriage lock relaxed position, which may be a position offset from the calibrated locked position, in which a properly locked needle retraction slide top plate 1112 will no longer exert pressure on the flippers 1074, and therefore the flippers 1074 may be safe to retract. Conversely, if the needle retraction slide top plate 1112 is not properly locked, this position may be designed to maintain sufficient pressure on the flippers 1074 to prevent them from retracting. This position may allow the handheld device 1000 to reliably detect proper locking of the needle retraction slide 1110.

[0065] Some configurations of the present disclosure include a vertical carriage extraction position, which may be a position offset from the calibrated unlocked position, in which the needle retraction slide 1110 is not unlocked and the extended needle may be behind the tissue stabilizer 2014. This position is where the vertical carriage assembly 1108 can extract the needle (including the tissue graft) from the tissue after harvesting and prior to implantation. Advantageously, this position may prevent the tissue graft from being exposed since the needle remains extended.

[0066] Some configurations of the present disclosure include a harvest recovery mode that can occur during the harvest process. The harvest recovery mode can include attempting to continue to deploy the needle module into the tissue. Additionally, the harvest recovery mode can be automatic and fully controlled by on-board software (i.e., no user interaction is required). In some embodiments, the harvest recovery mode can include reversing the motion of the horizontal carriage assembly 1082 for a predetermined distance or time interval. The horizontal carriage assembly 1082 can then advance forward and again attempt to deploy the needle module into the tissue.

[0067] Some configurations of the present disclosure can include an extraction recovery mode, which can occur after the needles are deployed (and when the handheld device 1000 is returning the horizontal carriage to its home position). In some configurations, the horizontal carriage assembly 1082 can get stuck due to increased friction from the needle modules. If this occurs, the handheld device 1000 can flash the implant light (on the implant input 1022) white to indicate that extraction recovery is required. The user can then ease the downward force on the tissue and press the implant input 1022 to allow the handheld device 1000 to continue extracting the needles from the tissue.

[0068] <Skin graft assembly vertical movement> In some configurations, the various components corresponding to the handheld device 1000 and the cartridge 2002 may have predefined behaviors based on the current mode of the handheld device 1000 (e.g., initialization, harvesting mode, planting mode, etc.).

[0069] In some configurations, the vertical component assembly 1046 can have a predefined "loading" configuration that corresponds to loading the cartridge 2002 into the handheld device 1000. During loading, for example, the solenoid plunger bar 1106, the flippers 1074, and the needle retraction slide 1110 can be retracted (retracting the needle). The vertical carriage assembly 1108 can be set to a home position (as described above).

[0070] In some configurations, the vertical component assembly 1046 can have a predefined "initialization" configuration. During initialization, for example, each flipper 1074 can be extended (flipper out) and the needle retraction slide 1110 can be locked with the needle retraction spring 1120 loaded (needle remains retracted). The vertical carriage assembly 1108 can be set to a locked position (see above). With each flipper 1074 extended, the vertical carriage assembly 1108 can move up to a locked position. The extended flippers 1074 can hold the needle retraction slide 1110 in place. Once the vertical carriage assembly 1108 reaches the locked position, the needle retraction slide latch 1116 can lock the top plate 1112 in place with the needle retraction spring 1120 loaded. In some configurations, this prevents the needle from moving from its retracted state.

[0071] In some configurations, the vertical component assembly 1046 can have a predefined "initialization" configuration, which may correspond to the skin grafting system 3000 being ready for harvesting. During the initial configuration, for example, each flipper 1074 can be retracted (flipper-in) and the needle retraction slide 1110 can be locked with the needle retraction spring 1120 loaded. In some configurations, this prevents the needle from moving from its retracted state. In some configurations, the vertical carriage assembly 1108 can be moved back to a home position.

[0072] In some configurations, the vertical component assembly 1046 can have a predefined "harvest" position that corresponds to an applied user force. During harvest position, for example, the needle retract slide 1110 can remain locked with the needle retract spring 1120 loaded and the needle retracted. In some configurations, the vertical carriage assembly 1108 can remain in the harvest position. When the user places the skin grafting system 3000 at the donor site and applies a downward force, the user detects that the tissue stabilizer 2014 moves a small amount in a direction opposite to the applied force, which causes the indicator lights 1016 and 1020 to illuminate, indicating to the user that proper alignment exists for harvesting. In some configurations, the indicator light 1016 can illuminate green to provide the user with a visual confirmation of the force.

[0073] In some configurations, the vertical component assembly 1046 can have a predefined "harvesting" configuration that corresponds to needle deployment. During this harvesting configuration, for example, the solenoid plunger bar 1106 can advance and the needle retraction slide 1110 can remain locked with the needle retraction spring 1120 loaded. In particular, needles (e.g., from the microneedle array 2006) can be deployed into tissue. In some configurations, the vertical carriage assembly 1108 can remain in a home position and user force can still be applied via the handheld device 1000. When the user pulls the trigger 1014, the skin grafting assembly 3000 can begin a harvesting sequence. Thus, the skin grafting assembly 3000 can advance each microneedle array row into tissue by striking the hammers 1098a, 1098b with the solenoid plunger bar 1106.

[0074] In some configurations, the vertical component assembly 1046 can have a predefined "extraction" configuration. During the extraction configuration, for example, the solenoid plunger bar 1106 can be retracted and the needle retraction slide 1110 can remain locked loaded against the needle retraction spring 1120. The needles (e.g., from the microneedle array 2006) can remain deployed in the tissue at the start of extraction. The vertical carriage assembly 1108 can move to an extraction position (described above). In some configurations, after harvesting is complete, the skin grafting system 3000 can extract the needles by lifting all of the needles in the microneedle array 2006 at once. The needles can be lifted to the extraction position and the user force can be removed. In some configurations, the needles can remain advanced against the pins (e.g., pins 2052) and the tissue stabilizer 2014 can remain stationary as the needles retract.

[0075] In some configurations, the vertical component assembly 1046 can have a predefined "implant" configuration. During the implant configuration, for example, the needle retraction slide 1110 can be in a retracted position with the needle also in a retracted state. In some configurations, the vertical carriage assembly 1108 can move from the extraction position. When a user initiates an implant sequence, the skin grafting system 3000 can move the vertical carriage assembly 1108 from the extraction position, which can release the loaded needle retraction spring 1120 and needle retraction slide 1110. This movement can thus retract the needle against the pins (e.g., pins 2052), thus exposing the graft and positioning the components for the implant sequence.

[0076] In some configurations, the vertical component assembly 1046 can have a "planted" configuration that corresponds to an advanced needle position. During this planted configuration, for example, the solenoid plunger bar 1106 can advance and the needle retraction slide 1110 can advance (as can the needles). In some configurations, the solenoid plunger bar 1106 can advance and first hit the top plate 1112 and then the needle modules (e.g., in the microneedle array 2006). This can push the top plate 1112 forward of the needle carrier, thus preventing damage to the carrier. Advancement of the needles, followed by rapid retraction of those needles (due to the unlocked top plate 1112), can disperse the graft at the recipient site.

[0077] <Power-on self-test> In some configurations, the handheld device 1000 may perform a self-test upon start-up (e.g., when the handheld device 1000 is first powered on). In some configurations, the self-test may occur when the handheld device 1000 is plugged in to receive power and the standby input 1018 is pressed and released. In some configurations, the standby input 1018 may flash green for the duration of the self-test. The horizontal carriage assembly 1082 may then move forward a very small distance such that the horizontal flag sensor 1064 is cleared. The horizontal carriage assembly 1082 may then return to the home position.

[0078] During the self-test, the vertical carriage assembly 1108 may move upwards a very small distance so that the vertical flag 1118 clears the sensor. The vertical carriage assembly 1108 may then return to the home position. In some configurations, the vertical carriage assembly 1108 may move upwards to an unlocked position where it may move the needle retract slide latch 1116 before returning to the home position. This may, for example, release the needle retract slide 1110 when it is locked (e.g., the cartridge 2002 is locked inside).

[0079] In some configurations, the horizontal carriage assembly 1082 can be moved to a predetermined position (e.g., about two-thirds of the way through its full extent) to verify that a cartridge (e.g., cartridge 2002) is not present, after which the horizontal carriage assembly 1082 can return to the home position.

[0080] During the self-test, the flipper 1074 may extend and then retract back. Additionally, in some configurations, some or all of the lights on the handheld device 1000 may flash (e.g., indicator lights 1016, 1020, plant input 1022, etc.). Once the self-test is complete, the standby input 1018 may, for example, be lit solid green, thereby indicating that the self-test was successful.

[0081] <Cartridge loading and initialization> In some configurations, the skin grafting system 3000 can have a predefined cartridge loading and initialization process. A user can open the loading door 1004 and then slide the cartridge assembly 2000 (i.e., including the cartridge cover 2004) into the engagement slot 1002. The cartridge latch 1114 can lock onto the cartridge 2002. The user can then remove the cartridge cover 2004 and close the loading door 1004, which can activate an internal loading door switch.

[0082] The initialization process can further include moving the horizontal carriage assembly 1082 from the home position, which allows the horizontal carriage assembly 1082 to detect the presence of a cartridge by stalling on the first cartridge segment. The horizontal carriage assembly 1082 can then return to the home position. In addition, the vertical carriage assembly 1108 can move a small amount so that the vertical flag 1118 clears the sensor, after which the vertical carriage assembly 1108 can return to the home position.

[0083] In some configurations, the flipper 1074 can extend outwardly above the top plate 1112. The vertical carriage assembly 1108 can move to a locked position. In moving to the locked position, the flipper 1074 can hold the top plate 1112 in place while the needle retraction slide latch 1116 moves outward, and can eventually lock over the top plate 1112. Thus, the needle retraction spring 1120 can be held in compression. While this is happening, for example, the lock-down latch 1126 can spring out below the needle segment (e.g., in the microneedle array 2006) in preparation for locking the needle segment downward during a harvest sequence. In some configurations, the vertical carriage assembly can then move downward a small amount, and thus to a lock-relaxed position (described above). Additionally, the flipper 1074 can retract back inward.

[0084] The initialization process may further include returning the vertical carriage assembly 1108 to the harvesting position. The horizontal carriage assembly 1082 may engage the first needle segment (in the microneedle array 2006) by contacting the first needle segment, stalling, and then backing off a small, predetermined distance. The handheld device 1000 may then calculate the position of each needle segment. Once the initialization process is complete, the indicator light 1020 may illuminate white, indicating that the handheld device 1000 is ready for the harvesting sequence.

[0085] <Method of collection and extraction> In some configurations, a user can harvest and extract a tissue column using a harvesting process. A user can place the handheld device 1000 at the donor site with the tissue stabilizer 2014 pressed against the skin. The user can use one or both hands to apply force to the skin via the handheld device 1000. The interface component of the tissue stabilizer can move upward to compress the position sensing spring 1056 until the position sensing flag 1062 occupies the flag sensor. In some configurations, the indicator lights 1016, 1020 can illuminate green to indicate that the trigger 1014 is active.

[0086] Once the trigger 1014 is activated, the user can pull the trigger 1014 (while maintaining force on the skin) and the handheld device 1000 can begin the collection sequence. In some configurations, the indicator lights 1016, 1020 can flash green during collection and extraction periods. The position sense flag 1062 can be monitored during collection (while the solenoid is activated) to ensure sufficient force is maintained. The solenoid 1052 can rapidly advance the solenoid plunger bar 1106, which can advance the two hammers 1098a, 1098b and insert the first needle module into the tissue. Once inserted, the needle module moves past the needle module lockdown latch. The solenoid 1052 and hammers 1098a, 1098b can then be retracted and the needle segments can remain locked down in the tissue.

[0087] In some configurations, the horizontal carriage assembly 1082 can advance to the calculated position of the next needle segment. Alternatively, the position of the next needle segment can be recalculated or otherwise reverified throughout the harvesting process. The solenoid 1052 can rapidly advance the solenoid plunger bar 1106, which can advance the two hammers 1098a, 1098b to insert the next needle module into the tissue. Once inserted, the needle module can move past the lockdown latch 1126. The lockdown latch 1126 can bounce back, and the solenoid 1052 and hammers 1098a, 1098b can retract. This insertion process can be repeated until all needle segments are inserted into the tissue.

[0088] According to some configurations, after insertion of all segments is complete, the horizontal carriage assembly 1082 can return to the home position. The vertical carriage assembly 1108 can move upward to the extraction position to extract the needle from the tissue and safely position the needle inside the tissue stabilizer 2014. The indicator lights 1016, 1020 can stop flashing green and turn off. Additionally, the implant input 1022 can illuminate white, indicating that the handheld device 1000 is ready to proceed with the implantation process. Once the harvesting process is complete, the user can remove the force on the tissue and lift the handheld device 1000 away.

[0089] <How to plant> In some configurations, the user can implant the tissue column after the harvest process. Once the user removes the handheld device 1000 from the donor site (with the tissue column harvested), the needle can be safely placed inside the cartridge 2002 (e.g., in the tissue stabilizer 2014). With the recipient site ready for the tissue column, the user can activate the implant mode by pressing the implant input 1022. In some configurations, the implant input 1022 can change from a white illumination to a green illumination.

[0090] In some configurations, the user can position the cartridge 2002 directly over the recipient site. The user can then pull the trigger 1014, which can move the vertical carriage assembly 1108 out of the extraction position, thereby releasing the needle retraction slide 1110 and retracting the needle behind the pin (e.g., pin 2052). The handheld device 1000 can rapidly advance the solenoid plunger bar 1106, which in response pushes both the needle retraction slide 1110 and the needle module. The needle retraction slide 1110 can remain pushed forward of the needle module to prevent damage to the needle module. The solenoid plunger bar 1106 can then retract, which can retract the needle retraction slide 1110 (pulling the needle module back with the needle retraction slide 1110). The process of rapidly advancing the solenoid plunger bar 1106 can be repeated several times to ensure that as much of the graft as possible is placed within the recipient site. In some configurations, the solenoid 1052 can be actuated six times. After the implantation process is complete, the vertical carriage assembly 1108 can return to the home position with the needle retraction slide 1110 unlocked.

[0091] <Cartridge removal> In some configurations, once the user has completed the harvesting and planting process, the user can open the loading door 1004, press the cartridge latch 1114, and slide the cartridge 2002 outward. In some configurations, if the user wishes to complete another harvest with the same cartridge 2002, the user can open and close the loading door 1004 (i.e., without removing the cartridge 2002). This can initiate another initialization process via the handheld device 1000. Alternatively, the user can initiate another initialization process via an input (not shown) on the user interface 1008.

[0092] <Fluid ingress protection> As mentioned above, the cartridge 2002 can be used for multiple collection and implantation processes (for one patient) before being removed from the handheld device 1000 and subsequently discarded. In some cases, repeated tissue punctures through the microneedle array 2006 can cause localized bleeding. Additionally, repeated deployment and retraction of the needle modules can cause blood dispersion. Since the cartridge 2002 can be disposable, for example, blood dispersion on the outside of the microneedle chamber 2018 may not be of great concern. However, the handheld device 1000 may be reusable. Therefore, it may be advantageous to prevent blood from entering the housing 1036. For example, if blood does enter the housing 1036, extensive cleaning and disinfection procedures would be required.

[0093] The present disclosure includes systems and methods for preventing blood ingress. In particular, the present disclosure provides a clinical soiling control system that can prevent fluid ingress into the handheld device 1000 (e.g., via the housing 1036) and / or general fluid exposure to the reusable handheld device 1000 (e.g., outside the housing 1036). In some embodiments, the clinical soiling control system can protect the interface that occurs between the engagement slot 1002 and the cartridge 2002 (see, e.g., FIG. 1). Additionally, the clinical soiling control system of the present disclosure can be designed to protect the interface that occurs between the loading door 1004 and the cartridge 2002 (see, e.g., FIG. 1). In some configurations, the clinical soiling control system can include an absorbent material to further prevent fluid ingress onto and / or into the housing 1036.

[0094] 8A-8B, a clinical soil control system is shown according to some embodiments of the present disclosure. Typically, the clinical soil control system can include a strap (e.g., gasket assembly 6000), a device cover 5000, and an absorbent material 8000 (see, e.g., FIG. 15A). In some configurations, the clinical soil control system can include one of the strap (e.g., gasket assembly 6000), the device cover 5000, and the absorbent material 8000, or various combinations thereof.

[0095] As shown in Figures 8A-9B, the clinical soil control system can include a device cover 5000. The device cover 5000 can cover a portion of the handheld device 1000 or can cover the entire handheld device 1000. In some configurations, the device cover 5000 can include one or more openings that can facilitate access to the handheld device 1000 and the cartridge 2002 during the skin grafting process. As shown in Figure 8A, by way of example, the cartridge 2002 can extend into the device cover 5000 through the cartridge opening 5002. In this way, the cartridge 2002 can contact the patient (e.g., donor site) while preventing clinical soil from contacting the handheld device 1000. As mentioned above, the cartridge 2002 can be disposable (i.e., discarded after use with one patient), while the handheld device 1000 can be reusable (i.e., used for multiple patients).

[0096] In some embodiments, the device cover 5000 can be substantially transparent. As an example, the device cover 5000 can include a polyethylene film that may have a thickness in the range of 0.01 mm to 0.5 mm, or in the range of 0.06 mm to 0.09 mm, which can allow a user to see through the device cover 5000. As another example, the device cover 5000 can include a thermoplastic polyurethane that may have a thickness in the range of about 0.7 mm, or in the range of 0.1 mm to 2.0 mm, or in the range of 0.6 mm to 0.8 mm, which can also allow a user to see through the device cover 5000. Broadly speaking, the thickness range of the polyethylene film and / or the thermoplastic polyurethane can be any value that provides a flexible membrane of material.

[0097] In some embodiments, the device cover 5000 can be a flexible polymer sheet. The flexible polymer sheet can be continuous in some embodiments. The device cover 5000 can also be a variety of other colors, such as white, black, blue, etc. In particular, the color of the device cover 5000 can be selected to visually highlight the location of any fluid that may have come into contact with the device cover 5000. For example, the device cover 5000 can be substantially transparent or translucent and white, blue, yellow, or other color that is significantly different from dark red blood to highlight the location of blood that may have come into contact with the device cover 5000.

[0098] The device cover 5000 can include an access opening 5004, such as the access opening 5004 shown in FIGS. 8A-9B. The access opening 5004 can be sized to allow a user to hold the handheld device 1000 and interact with corresponding elements (e.g., user interface 1008, trigger 1014, loading door 1004, etc.) during the skin grafting process. Additionally, in some configurations, the access opening 5004 can be sized to accommodate the handheld device 1000 within the interior volume 5006 of the device cover 5000. Additionally, the interior volume 5006 can be sized to allow a user to interact with elements of the handheld device 1000 during the skin grafting process. As an example, the interior volume 5006 can provide for the opening and closing of the loading door 1004, which can initiate the initialization process described above. As another example, the interior volume 5006 can provide for user interaction with the user interface device 1000.

[0099] As shown in Figure 8A, the cartridge opening 5002 is contactable with a band, such as a gasket assembly 6000. Generally, the gasket assembly 6000 is securable to the outer periphery of the cartridge opening 5002 and is contactable with an outer portion of the cartridge 2002. The gasket assembly 6000 is described in more detail below with respect to Figures 10-13B.

[0100] With particular reference to Figures 9A-9B, a device cover 5000 according to some embodiments of the present disclosure is shown. As shown, the access opening 5004 can include a means for restricting the size of the access opening 5004. As an example, Figures 9A-9B are shown including an elastic band 5008 as the means for restricting the size of the access opening 5004. The elastic band 5008 can be stretched to provide for insertion of the handheld device 1000 into the interior volume 5006. Conversely, the elastic band 5008 can be contracted to reduce the size of the access opening 5004 such that the user can still grasp the handheld device 1000 through the access opening 5004, but the smaller opening prevents clinical dirt from entering the interior volume 5006 during the skin grafting process. The elastic band 5008 can be sewn or attached by adhesive around the periphery of the access opening 5004. In other embodiments, the restricting means can include a drawstring attached to a portion of the access opening 5004. The drawstring can be tightened and loosened as desired by the user to reduce the access opening 5004 to prevent the ingress of clinical soil.

[0101] 10 through 13C, a strap (e.g., gasket assembly 6000) according to an embodiment of the present disclosure is shown. The gasket assembly can prevent clinical soil from contacting the handheld device through the cartridge opening 5002. In some embodiments, the gasket assembly 6000 can include a gasket case lower portion 6002, a gasket 6004, and a gasket case upper portion 6006 (see, e.g., FIG. 10). As shown, the gasket 6004 can be disposed between the gasket case lower portion 6002 and the gasket case upper portion 6006. In some embodiments, the gasket 6004 can be secured to the gasket case lower portion 6002, for example, with an adhesive. Similarly, the gasket case lower portion 6002 and the gasket case upper portion 6006 can be joined to one another via adhesive and / or inter-engaging portions.

[0102] 11A-11C, a gasket case lower portion 6002 according to an embodiment of the present disclosure is shown in more detail. As shown, FIG. 11A provides a front view, FIG. 11B provides a back view, and FIG. 11C provides a side view of the gasket case lower portion 6002. In some embodiments, the gasket case lower portion 6002 can include a distal side 6008 (e.g., disposed away from the skin graft system 3000) and a proximal side 6030 (e.g., disposed towards the skin graft system 3000).

[0103] 11A, the gasket case lower portion 6002 may include an outer edge 6012 and an inner engagement edge 6010. The engagement edge 6010 may contact the exterior of the tissue stabilizer 2014 of the cartridge 2002. In some embodiments, the engagement edge 6010 may be secured firmly against the tissue stabilizer 2014. The gasket case lower portion 6002 may further include a retainer surface 6014 that may support the gasket 6004 as part of the gasket assembly 6000. In some embodiments, the gasket 6004 may be secured to the retainer surface 6014 by an adhesive, which may prevent the gasket 6004 from being repositioned during the skin grafting process. When the gasket 6004 is positioned on the retainer surface 6014, the gasket 6004 may contact the exterior of the tissue stabilizer 2014. In some embodiments, the cartridge 2002 may be inserted into an opening 6022 in the gasket case lower portion 6002.

[0104] 11A, the gasket case lower portion 6002 may include a ridge 6016 and a recess 6018 disposed between the outer edge 6012 and the retainer edge 6056. In some embodiments, the ridge 6016 and the recess 6018 can be disposed such that the gasket case upper portion 6006 can be press-fit and held in the gasket case lower portion 6002. As mentioned above, an adhesive can be disposed between the gasket case upper portion 6006 and the gasket case lower portion 6002 to further maintain the structure of the gasket assembly 6000.

[0105] 11B and 11C, a proximal side 6030 of the gasket case lower portion 6002 and a side view of the gasket case lower portion 6002 are shown, respectively. The side view of FIG. 11C is taken along the cut line (C) shown in FIG. 11B. L). The proximal side 6030 can include an exterior surface 6032 that can be positioned relative to the cartridge 2002. As shown, the proximal side 6030 can include notches 6034a, 6034b, which can be recessed relative to the exterior surface 6032. In some embodiments, the notches 6034a, 6034b can be sized to provide an extended position for the cartridge arm 2020 (see, e.g., FIGS. 1 and 5B).

[0106] 12A-12B, a gasket 6004 is shown in accordance with an embodiment of the present disclosure. In particular, FIG. 12A is a front view of the gasket 6004, and FIG. 12B is a side view of the gasket 6004. The gasket 6004 can be sized to fit onto a retainer surface 6014 of the gasket case lower portion 6002, and an adhesive may be used to prevent movement of the gasket 6004 on the retainer surface 6014. As shown in FIG. 12A, the gasket 6004 can include an engagement edge 6040 and an outer edge 6042. The engagement edge 6040 can contact the cartridge 2002.

[0107] In some embodiments, the gasket 6004 can be formed from silicone or a different hydrophobic material that can act as a barrier. The cartridge 2002 can be inserted into the gasket opening 6024, which can press the gasket 6004 against the outside of the cartridge 2002 (e.g., the tissue stabilizer 2014). Thus, the gasket 6004 can form a seal with the cartridge 2002 that can prevent clinical dirt from entering the handheld device 1000 during the skin grafting process.

[0108] 13A-13B, a gasket case top 6006 is shown in accordance with an embodiment of the present disclosure. In particular, FIG. 13A is a back view of the gasket case top 6006 and FIG. 13B is a side view of the gasket case top 6006. In some embodiments, the gasket case top 6006 can include a distal side 6066 (e.g., positioned away from the skin graft system 3000) and a proximal side 6064 (e.g., positioned towards the skin graft system 3000).

[0109] 13A, the gasket case top 6006 may include an outer edge 6052 and an inner engagement edge 6054. In some embodiments, the outer edge 6052 may be aligned with the outer edge 6012 (corresponding to the gasket case bottom 6002) and the inner engagement edge 6054 may be aligned with the inner engagement edge 6010 (corresponding to the gasket case bottom 6002) for the gasket assembly 6000. The engagement edge 6054 may contact the outside of the tissue stabilizer 2014 of the cartridge 2002. In some embodiments, the engagement edge 6054 may be secured firmly against the tissue stabilizer 2014. The gasket case top 6006 may further include a retainer surface 6058 that may support the gasket 6004 as part of the gasket assembly 6000. In some embodiments, the gasket 6004 can be secured to the retainer surface 6058 (similar to the retainer surface 6014 of the gasket case lower portion 6002) with an adhesive, which can prevent the gasket 6004 from being repositioned during the skin grafting process. When the gasket 6004 is positioned on the retainer surface 6058, the gasket 6004 can contact the exterior of the tissue stabilizer 2014. In some embodiments, the cartridge 2002 can be inserted into the opening 6050 in the gasket case upper portion 6006.

[0110] As shown in FIG. 13A , the gasket case top 6006 may include a ridge 6062 and a recess 6060 disposed between the outer edge 6052 and the retainer edge 6056. In some embodiments, the ridge 6062 and the recess 6060 may be disposed such that the gasket case top 6006 may be press-fit and retained in the gasket case bottom 6002. In some embodiments, for example, the ridge 6062 of the gasket case top 6006 may be complementary (e.g., aligned, similarly sized, etc.) to the recess 6018 of the gasket case bottom 6002. Similarly, the recess 6060 of the gasket case top 6006 may be complementary (e.g., aligned, similarly sized, etc.) to the ridge 6016 of the gasket case bottom 6002. As discussed above, an adhesive may be disposed between the gasket case top 6006 and the gasket case bottom 6002 to further maintain the structure of the gasket assembly 6000. In some embodiments, the gasket case upper portion 6006 can include an engagement surface 6068 protruding from the proximal side 6064. The engagement surface 6068 can be configured to insert into the gasket case lower portion 6002, which can help maintain the overall structure of the gasket assembly 6000.

[0111] In some embodiments, the gasket case top 6006 and / or the gasket case bottom 6002 can be secured to the periphery of the cartridge opening 5002 (i.e., corresponding to the device cover 5000). Additionally, a portion of the device cover 5000 adjacent the cartridge opening 5002 can be pressed between the gasket case top 6006 and the gasket case bottom 6002 such that the gasket assembly 6000 is secured to the periphery. In some embodiments, the gasket case top 6006 can be secured to an outer portion of the device cover 5000 using an adhesive. Similarly, the gasket case bottom 6002 can be secured to the inside of the device cover 5000 using an adhesive. As described above, an adhesive can further be used to bond the gasket case top 6006 to the gasket case bottom 6002. Thus, the gasket 6004 can be positioned and held between the gasket case bottom 6002 and the gasket case top 6006 such that contact between the gasket 6004 and the cartridge 2002 is maintained during the skin grafting process. Thus, the gasket assembly 6000 and device cover 5000 can inhibit ingress of fluids (e.g., clinical soils) into the interior volume 5006 of the device cover during the skin grafting process, thereby preserving the user's ability to reuse the handheld device 1000 without performing a potentially lengthy sterilization process of the internal components.

[0112] 14A-14E, another strap (e.g., gasket assembly 7000) is shown according to an embodiment of the present disclosure. The gasket assembly can prevent clinical soil from contacting the handheld device through the cartridge opening 5002. According to some embodiments, the gasket assembly 7000 can be substantially unitary (e.g., manufactured as a unitary component). Alternatively, the gasket assembly 7000 can include a removably secured portion. In some embodiments, the gasket assembly 7000 can be formed as part of the cartridge 2002 (i.e., manufactured as a unitary component). Additionally, in some embodiments, the device cover 5000 can be secured directly to the cartridge 2002 (e.g., via adhesive, welding, etc.), thus forming a unitary component.

[0113] FIG. 14A is a front perspective view of a gasket assembly 7000 according to some embodiments. Conversely, FIG. 14B is a rear perspective view of the gasket assembly 7000 of FIG. 14A. In some embodiments, the gasket assembly 7000 can include a distal side 7002 (e.g., disposed away from the skin grafting system 3000) and a proximal side 7004 (e.g., disposed towards the skin grafting system 3000). FIG. 14C is a front view of the gasket assembly 7000 showing the distal side 7002 in more detail and illustrating the front surface 7014. Similarly, FIG. 14D is a rear view of the gasket assembly 7000 showing the proximal side 7004 in more detail and illustrating the rear surface 7024. FIG. 14E shows a side view of the gasket assembly 7000.

[0114] As shown, the gasket assembly 7000 may include an outer edge 7022 and an inner engaging edge that may accommodate the gasket 7006. The cartridge 2002 may be inserted into the opening 7016, which may cause the gasket 7006 to press against the outside of the cartridge 2002 (e.g., the tissue stabilizer 2014). Thus, the gasket 7006 may form a seal with the cartridge 2002 that may prevent clinical contaminants from entering the handheld device 1000 during the skin grafting process. In some embodiments, the gasket 7006 may be formed from silicone or a different flexible and / or hydrophobic material.

[0115] The gasket assembly 7000 is shown to include a protrusion 7012, which may include an inner edge 7010 and an outer edge 7020. The protrusion 7012 may help secure the cartridge 2002 when inserted into the opening 7016. The protrusion 7012 may contact the cartridge 2002 via the inner edge 7010 and a proximal edge in some embodiments. With particular reference to FIGS. 14B, 14D, and 14E, the proximal side 7004 is shown to include notches 7008a, 7008b, which may be recessed relative to the protrusion 7012. As shown, the notches 7008a, 7008b may be sized to provide an extended position for the cartridge arm 2020 (see, e.g., FIGS. 1 and 5B).

[0116] In some embodiments, the front surface 7014 can be positioned on the outside of the device cover 5000. The gasket assembly 7000 can be secured to the outer periphery of the cartridge opening 5002 (i.e., corresponding to the device cover 5000). In some embodiments, the gasket assembly 7000 can be secured to the outer portion of the device cover 5000 using an adhesive. For example, the rear surface 7024 of the gasket assembly 7000 (see, e.g., FIG. 14D) can be glued to the outer portion of the device cover. In other embodiments, the gasket assembly 7000 can be secured to the device cover 5000 using alternative methods.

[0117] As discussed above, the strap (e.g., gasket assembly 7000) and device cover 5000 can inhibit ingress of fluids (e.g., clinical soils) into the interior volume 5006 of the device cover during the skin grafting process, thereby preserving the user's ability to reuse the handheld device 1000 without undergoing a potentially lengthy sterilization process of the internal components.

[0118] 15A-15C, an absorbent material 8000 is shown according to an embodiment of the present disclosure. Specifically, FIG. 15A is a top view of the absorbent material 8000 corresponding to a clinical soil control system, FIG. 15B is a top view of the absorbent material 8000 disposed within a tissue stabilizer 2014, and FIG. 15C is a perspective view of the absorbent material 8000 disposed around a microneedle array 2006. Notably, in some embodiments, a repellent material (e.g., a hydrophobic material) can be used in place of the absorbent material 8000. The repellent material can act as a barrier around the microneedle array 2006, thus diverting clinical soil from the interior of the handheld device 1000.

[0119] In some embodiments, the absorbent material 8000 can inhibit infiltration of fluids (e.g., clinical soils) into the interior of the handheld device 1000 via the cartridge 2002. The absorbent material 8000 can include polyacrylate fibers that can absorb and retain fluids (e.g., fluids from a skin grafting process). Additionally, in some embodiments, the absorbent material 8000 can include hydrophilic fibers that can wick and retain fluids. As an example, the absorbent material 8000 can have substantially similar properties to Qwick™, an absorbent wound dressing commercially available from Medline Industries, Inc.

[0120] In some embodiments, the absorbent material 8000 may include multiple layers. The first layer may be, for example, a hydrophilic layer such as 100% TENCEL™, or a hydrophilic equivalent. The second layer may be, for example, a superabsorbent polymer. As used herein, a superabsorbent polymer (SAP) is a material that can absorb and retain extremely large amounts of liquid relative to its mass. The third layer may be, for example, polypropylene fibers. In some embodiments, additional or fewer layers may be included in the absorbent material 8000.

[0121] 15A-15C, the absorbent material 8000 may be cut to complement the size and shape of the tissue stabilizer 2014 and the microneedle chamber 2018. In some embodiments, the absorbent material 8000 may include an inner edge 8002 and an outer edge 8006. The inner edge 8002 may be positioned to substantially align with an opening of the tissue stabilizer 2014 (e.g., an edge of the microneedle chamber 2018). The outer edge 8006 may be disposed on an inner wall of the tissue stabilizer 2014. In some embodiments, the absorbent material 8000 may be secured to the inner surface of the tissue stabilizer 2014 using an adhesive. The adhesive may prevent migration of the absorbent material 8000 during the skin grafting process. For example, the absorbent material 8000 can be secured within the tissue stabilizer 2014 to prevent the absorbent material 8000 from impeding the movement of the microneedles 2050 during harvesting and / or implantation. In some embodiments, the adhesive can be in the form of a liquid or a film. Additionally, the absorbent material 8000 can be secured to the inner surface of the tissue stabilizer 2014 via various welding methods, such as RF welding. Other, e.g., mechanical, methods of securing the absorbent material 8000 to the tissue stabilizer 2014 can be used.

[0122] The absorbent material 8000 may include various cutouts 8004 to provide the features of the tissue stabilizer 2014. In particular, the cutouts 8004 may be positioned to provide clearance for the cartridge arm 2020 (as shown and described with respect to FIGS. 1 and 5B). In particular, the inner edge 8002 of the absorbent material 8000 may be flush with the edge of the microneedle chamber 2018, allowing fluid from the microneedle 2050 to be absorbed and maintained by the absorbent material 8000. Thus, the absorbent material 8000 may inhibit infiltration of fluids (e.g., clinical soiling) into the interior of the handheld device 1000 during the skin grafting process.

[0123] As mentioned above, in some embodiments of the present disclosure, the clinical soil control system can include a device cover 5000, a strap (e.g., gasket assemblies 6000, 7000), and an absorbent material 8000. In some configurations, the clinical soil control system can include one of the device cover 5000, the strap (gasket assemblies 6000, 7000), and the absorbent material 8000, or various combinations thereof.

[0124] 16A-16E show a clinical soil control system without a gasket assembly. The clinical soil control system includes a band (e.g., device cover 9000). The device cover 9000 includes a cartridge opening 9002 and an access opening 9003, and can cover a portion or the entirety of the handheld device 1000. The access opening 9003 can be sized to accommodate the handheld device 1000 within the interior volume 9006 of the device cover 9000 and further allow a user to hold and interact with the corresponding element of the handheld device 1000. As an example, the interior volume 9006 can provide for opening and closing a loading door 1004 that can initiate the initialization process described above. The device cover 9000 can include an elastic band and any other similar features as described with respect to the device cover 5000.

[0125] In some embodiments, the cartridge opening 9002 is sized and shaped to accommodate the cartridge 2002. In particular, the cartridge opening 9002 can accommodate the peripheral housing 2017 formed by the tissue stabilizer 2014. The cartridge opening 9002 can include a protrusion 9004 that forms the cartridge opening 9002. The protrusion 9004 can extend in a direction away from the interior volume 9006 of the device cover 9000 to a length that is less than, the same as, or greater than the length that the peripheral housing 2017 extends in a direction away from the body of the cartridge 2002. The protrusion 9004 has an inner surface 9010 that extends around an inner periphery of the protrusion 9004. In some embodiments, the protrusion 9004 can be made from the same or similar material as the body of the device cover 9000.

[0126] The cartridge opening 9002 can be sized and / or shaped to complement the size and shape of the peripheral housing 2017. For example, if the peripheral housing 2017 is a rectangular prism as shown in FIGS. 16A-16E, the inner surface 9010 and the cartridge opening 9002 can be shaped to contact the outer surface of substantially the same rectangular prism. The peripheral housing 2017, cartridge opening 9002, and inner surface 9010 of the protrusion 9004 can also be formed as other complementary shape combinations, such as a cone, a cube, a triangular prism, etc. When the cartridge 2002 is inserted into the cartridge opening 9002, the inner surface 9010 can contact the peripheral housing 2017 to form a seal that prevents ingress of fluids through the tissue stabilizer 2014 into the housing 1036. In some embodiments, the dimensions of the cartridge opening 9002 and / or the inner surface 9010 are smaller in size compared to the dimensions of the peripheral housing 2017. In this case, the device cover 9000 can be stretched over the cartridge 2002 to create a hermetic seal that prevents fluid ingress. Thus, the device cover 9000 is a strap over the cartridge opening 9002, even in the absence of a gasket assembly.

[0127] In some embodiments, the protrusion 9004 can include an elastic loop 9014 to securely but removably attach the protrusion 9004 to the cartridge 2002 (see, e.g., FIG. 16D). The elastic loop 9014 can be integrated into or separately attached to the exterior of the protrusion 9004 anywhere along the length of the protrusion 9004 that contacts the cartridge 2002. In some embodiments, the inner surface 9010 can include an elastomeric strip that forms a seal between the protrusion 9004 and the cartridge 2002. Additionally, in some embodiments, the inner surface 9010 can include an adhesive. Absorbent material 8000 (described above) can be disposed on the inner surface 9010, within the tissue stabilizer 2014, or in both locations. Various combinations of the above features can be used to modify or improve the seal created between the device cover 9000 and the cartridge 2002.

[0128] The clinical soiling control system can prevent fluid ingress into the handheld device 1000 (e.g., via the housing 1036) and / or general fluid exposure to the reusable handheld device 1000 (e.g., outside the housing 1036), thereby preserving the user's ability to reuse the handheld device 1000 without undergoing a potentially lengthy sterilization process of the internal components.

[0129] While the present disclosure may be susceptible to various modifications and alternative forms, specific configurations have been shown by way of example in the drawings and are described in detail herein. It should be understood, however, that the disclosure is not intended to be limited to the particular forms disclosed. Rather, the disclosure is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure as defined by the following appended claims.

[0130] Examples are used herein to disclose the present disclosure, including the best mode, and the description also enables those skilled in the art to practice the disclosure, including making and using any devices or systems and performing any incorporated techniques. The patentable scope of the disclosure is defined by the claims, and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if the elements are no different from those recited in the claims, or if they include equivalent elements not significantly different from those recited in the claims.

[0131] Finally, it is apparent that any of the processes or steps described herein may be combined, eliminated, or reordered, and therefore, this specification should be construed as illustrative only and not limiting of the scope of the present disclosure.

Claims

1. a handheld device comprising a device housing having a drive system secured therein; a cartridge including a plurality of hollow microneedles, the plurality of hollow microneedles being surrounded by a surrounding housing and configured to be manipulated by the drive system to extend and retract during a skin grafting process; an absorbent material disposed within the peripheral housing and surrounding the plurality of hollow microneedles; a device cover formed from a flexible polymer sheet defining an interior volume for the handheld device, the device cover including at least a first opening configured to receive the cartridge; A belt portion, the band includes a gasket; the gasket is secured to an outer periphery of the first opening of the device cover and configured to secure the device cover to at least one of the handheld device or the cartridge around the first opening to inhibit ingress of fluid into the interior volume of the device cover; The absorbent material is configured to inhibit infiltration of fluids through the cartridge and into the interior of the handheld device.

2. The skin graft system of claim 1 , wherein the absorbent material is secured to an inner surface of the peripheral housing using an adhesive.

3. The skin graft system of claim 1 , wherein the absorbent material is disposed within the peripheral housing such that an inner edge of the absorbent material is substantially aligned with an opening in the peripheral housing.

4. The skin grafting system of claim 1 , wherein the absorbent material comprises polyacrylate fibers configured to absorb and retain fluids resulting from the skin grafting process.

5. The skin grafting system of claim 1 , wherein the absorbent material comprises hydrophilic fibers configured to wick and retain fluids resulting from the skin grafting process.

6. The skin graft system of claim 1 , wherein the absorbent material comprises multiple layers including a first layer comprising a hydrophilic material and a second layer comprising a superabsorbent polymer.

7. The skin graft system of claim 6 , wherein the plurality of layers further comprises a third layer comprising polypropylene fibers.

8. The skin graft system of claim 1 , wherein the flexible polymer sheet is constructed from a thermoplastic polyurethane having a thickness within the range of 0.1 mm to 2.0 mm.

9. a handheld device comprising a device housing having a drive system secured therein; a cartridge including a plurality of hollow microneedles, the plurality of hollow microneedles being surrounded by a surrounding housing and configured to be manipulated by the drive system to extend and retract during a skin grafting process; a device cover formed from a flexible polymer sheet defining an interior volume for the handheld device, the device cover including at least a first opening configured to receive the cartridge; A belt portion, the band includes a gasket; A skin graft system, wherein the gasket is secured to an outer periphery of the first opening of the device cover and configured to secure the device cover to at least one of the handheld device or the cartridge around the first opening to inhibit ingress of fluid into the interior volume of the device cover.

10. the device cover further includes a second opening; The skin grafting system of claim 9 , wherein the second opening is configured to accommodate the handheld device within the interior volume and allow access to the handheld device during the skin grafting process.

11. The skin graft system of claim 10 , wherein the second opening includes a means for limiting the size of the second opening.

12. The skin graft system of claim 9 , further comprising an absorbent material adhered to an interior of the peripheral housing and configured to inhibit ingress of fluids into the interior of the handheld device.

13. The skin graft system of claim 12 , wherein the absorbent material comprises hydrophilic fibers configured to wick fluid away from the plurality of hollow microneedles.

14. The skin graft system of claim 12 , wherein the absorbent material surrounds the plurality of hollow microneedles.

15. The skin graft system of claim 12 , wherein the absorbent material comprises multiple layers including a first layer comprising a hydrophilic material and a second layer comprising an absorbent polymer.

16. a device cover formed from a flexible polymeric sheet defining an interior volume for a skin graft device, the device cover including at least a first opening configured to receive a portion of the skin graft device; A belt portion, the band includes a gasket; A clinical soiling control system, wherein the gasket is secured to an outer periphery of the first opening of the device cover and configured to secure the device cover to the skin grafting device around the first opening to inhibit ingress of fluids into the interior volume of the device cover during a skin grafting process performed using the skin grafting device.

17. 17. The clinical soil control system of claim 16, wherein said flexible polymer sheet is constructed from thermoplastic polyurethane.

18. 17. The clinical soil control system of claim 16, wherein said flexible polymer sheet is translucent and white, blue or yellow in color.

19. the device cover further includes a second opening; 17. The clinical soil control system of claim 16, wherein the second opening is configured to accommodate the skin grafting device in the interior volume and has a size to allow access to the skin grafting device during the skin grafting process.

20. 20. The clinical soil control system of claim 19, wherein the second opening includes an elastic band that limits a size of the second opening.

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