System and method for clinical soil control for skin grafting system

Abstract

To provide systems and methods for controlling clinical soil.SOLUTION: A system includes a device cover 5000 formed of a flexible polymer sheet defining an interior volume for a skin grafting device, and includes at least a first opening configured to receive a portion of the skin grafting device. The system further includes a cincture 6000 having a gasket configured to be affixed to a perimeter of the first opening of the device cover and to secure the device cover about the first opening to the skin grafting device to inhibit fluid ingress into the interior volume 5006 of the device cover during a skin grafting process performed using the skin grafting device.SELECTED DRAWING: Figure 8A

Description

Technical Field

[0001] <Cross - Reference to Related Applications> This application claims the benefit of U.S. Patent Application No. 16 / 741,535, filed on January 13, 2020, the disclosure of which is hereby incorporated by reference in its entirety for all purposes.

[0002] The subject matter disclosed herein generally relates to a skin grafting system, and more particularly to a system that may include an apparatus for harvesting and implanting skin microcolumns.

Background Art

[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 damaged skin and other tissues and / or to promote healing resulting from trauma, wounds, burns, surgery, and birth defects. The availability of tissue for autografting can be limited by the characteristics of candidate donor sites, including the number and / or total area of tissue grafts, the healing behavior of the donor site, the similarity between the donor site and the recipient site, aesthetic considerations, and the like.

[0004] Skin grafting can be performed surgically. For example, a conventional autograft procedure may involve excising or surgically removing burned tissue, selecting a donor site that can be an area from which healthy skin used as a cover for the cleaned burn area will be removed, and harvesting the graft by removing it from the donor site (e.g., using an instrument similar to an electric shaver). Such an instrument (e.g., a dermatome) may be configured to gently shave thin tissue slices (e.g., split-thickness grafts about 10 / 1000 inches thick) from the skin of the uninjured donor site for use as skin grafts. 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 the healing process of a second-degree burn.

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

[0006] The sheet graft can improve the appearance of the repaired tissue site. For example, the sheet graft may be used in large areas of the face, neck, and hands (if they are damaged), so that these more visible parts of the body can have less noticeable scars after healing. The sheet graft can be used to cover the entire area of the skin that has been burned or damaged. Since fluid (e.g., hematoma) accumulation may occur under the sheet graft after placement, a small area of the sheet graft may be lost after placement.

[0007] When it is difficult to cover with a sheet graft, a mesh skin graft can be used to cover a wider area of an open wound. Meshing of the skin graft can facilitate expanding the skin tissue from the donor site to cover a larger area. Also, when they are placed over the wound, it can facilitate the drainage of blood and body fluids from under the skin graft, which can help prevent graft loss. The expansion ratio of the mesh graft (e.g., the ratio of the area of the un-stretched graft to the area of the stretched graft) can typically be from about 1:1 to about 1:4. For example, the donor skin can be meshed at a ratio of about 1:1 or about 1:2, but a larger expansion ratio may make the graft more fragile, and scarring of the mesh graft may occur as it heals and / or the healing time may be longer.

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

[0009] ​As an alternative to autografts, skin tissue obtained from a recently deceased individual (e.g., a homograft, allograft, or cadaver skin) can be used as a temporary cover for the cleaned wound area. Non-meshed 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 cadaver allografts can then be removed prior to permanent autografting.

[0010] A xenograft or heterograft can refer to skin taken from one of various animals, such as a pig. Xenograft skin tissue can 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, religious, economic, or cultural objections to the use of human cadaver skin may also be a factor leading to the use of xenografts. Wound coverage using xenografts or allografts is generally a temporary procedure that can be used until autograft harvesting and placement are possible.

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

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

[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 harvesting process. SUMMARY OF THE INVENTION

[0014] According to some embodiments of the present disclosure, a skin grafting system is provided. The skin grafting system includes a handheld device including a device housing that secures a drive system therein. The skin grafting 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 operated by the handheld device to extend and retract during the skin grafting process. Further, the skin grafting system includes 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 that defines an internal volume of the handheld device. The device cover includes at least a first opening configured to receive the cartridge. The skin grafting system further includes a band. The band includes a gasket, the gasket being fixed to the outer periphery of the first opening of the device cover and fixing the device cover to at least one of the handheld device or the cartridge around the first opening so as to suppress the intrusion of fluid into the internal volume of the device cover. Further, the absorbent material is configured to suppress the intrusion of fluid from the cartridge into the interior of the handheld device.

[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 that secures a drive system 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 operated by a drive system to extend and retract during a skin grafting process. Additionally, the system includes a device cover formed from a flexible polymer sheet that defines an internal volume of the handheld device and includes at least a first opening configured to receive the cartridge. The system further includes a band that includes a gasket, the gasket being fixed to an outer periphery of the first opening of the device cover and configured to fix 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 internal volume of the device cover.

[0016] According to some embodiments of the present disclosure, a system for controlling clinical soiling is provided. The system includes a device cover formed from a flexible polymer sheet that defines an internal volume for a skin grafting device and includes at least a first opening configured to receive a portion of the skin grafting device. The system further includes a band that includes a gasket, the gasket being fixed to an outer periphery of the first opening of the device cover and configured to fix the device cover to the skin grafting device around the first opening to inhibit ingress of fluid into the internal volume of the device cover during a skin grafting process performed using the skin grafting device.

[0017] The following description and the accompanying drawings detail specific exemplary embodiments of the present disclosure. However, these embodiments are only illustrative of some of the various ways in which the principles of the present disclosure can be used. Other embodiments and features will become apparent by considering 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, and like reference numerals indicate like elements.

Brief Description of the Drawings

[0019]

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[0020] The following discussion is presented to enable one skilled in the art to make and use the systems and methods of the present disclosure. Various modifications to the illustrated embodiments will be readily apparent to those skilled in the art, and the high-level principles herein can be applied to other embodiments and applications without departing from the embodiments of the present disclosure. Accordingly, the embodiments of the present disclosure are not intended to be limited to the embodiments shown, but rather should 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. Also, it should be understood that the expressions and terms used herein are for the purpose of description and should not be regarded as limiting. As used herein, "including", "comprising" or "having" and variations thereof mean including the items listed thereafter and equivalents thereof as well as additional items.

[0022] Unless specifically stated or limited otherwise, the terms "mounted", "connected", "supported" and "coupled" and variations thereof are widely used and include direct and indirect mounting, connection, support and coupling. Further, "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 and is not necessarily electrically or mechanically connected. Similarly, unless otherwise specified, " coupled" means that one element / feature is directly or indirectly coupled to another element / feature and is not necessarily electrically or mechanically coupled.

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

[0024] As described above, the present disclosure generally relates to a skin grafting system, and more particularly to a system comprising an apparatus for harvesting and implanting skin microcolumns. In some situations, the process of harvesting skin microcolumns can involve penetrating donor site tissue. The harvesting of microcolumns usually causes minimal but often local bleeding. The amount of blood from the donor site can depend on various factors such as, for example, the number of tissue punctures / perforations, 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 treatment, donor site treatment, and / or co-existing diseases. In some situations, it may be advantageous to prevent the contact and / or infiltration of blood into a part of the skin grafting system. In particular, it may be advantageous to prevent the infiltration of blood into reusable elements of the skin grafting system.

[0025] As an example, in a healthcare facility, there are often standard cleaning, disinfection, and / or sterilization procedures that must be performed when an instrument is reusable between patients. Specifically, to minimize the risk of infection spread, all blood and body substances should be treated as potentially infectious. When using complex instruments, blood ingress into the instrument housing can result in, among other things, procedure delays, long 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) corresponding 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 No. 16 / 592,312, entitled "System and Method for Fluid Ingress Control for a Skin Grafting System," filed on October 3, 2019, the disclosure of which is hereby incorporated by reference in its entirety.

[0026] In some embodiments, a system for preventing blood or fluid ingress into a skin grafting system can comprise a cincture. As used herein, the term cincture is defined as an element that partially or entirely encloses (e.g., thereby joining components together or forming a seal that separates components). Further, as used herein, the term seal is defined as a junction between elements, and the junction creates a barrier that helps prevent fluid ingress.

[0027] Next, referring to FIG. 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 will be 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., without pins).

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

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

[0030] Next, referring to FIGS. 3A through 3B, a cutaway view of the handheld device 1000 according to the configuration of the present disclosure is shown. The handheld device 1000 is shown to include various internal controllers. In some configurations, the handheld device 1000 can include a power module 1028, a solenoid controller 1030, and / or a main controller 1032. The power module 1028 can communicate electrically with a power input 1038. In some configurations, the drive system 1034 may include a solenoid that communicates with the solenoid controller 1030.

[0031] Further referring to FIGS. 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 attachment cover can each be injection molded separately. The left enclosure half and the right enclosure half can be formed of a rigid plastic substrate and, in some configurations, can be formed of a softer elastomeric overmold section. Similarly, the loading door 1004 and the enclosure attachment cover can be formed of a rigid 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 configured to support various printed circuit boards (PCBs). The ribs can space the PCBs (e.g., the power module 1028, the solenoid controller 1030, and the main controller 1032) from 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 operating shock of the internal subassembly 1034 (e.g., from the user, from internal moving components) and protect the internal subassembly 1034 from damage due to external shock (e.g., from a drop of the handheld device 1000).

[0032] Next, referring to FIGS. 4A through 4E, various internal assemblies corresponding to the handheld device 1000 are shown for several configurations. FIG. 4A shows an internal sub-assembly 1034 that can 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 can include a corresponding flipper assembly (e.g., a left flipper assembly 1048a, a right flipper assembly 1048b). In some configurations, the horizontal component assembly 1044 can include a horizontal motor 1050. Further, the vertical component assembly 1046 may include a solenoid 1052.

[0033] Further, referring to FIGS. 4A through 4E, particularly FIGS. 4B and 4C, further exemplary details of the left and right frame assemblies 1040a, 1040b are shown for several configurations. In some configurations, the left frame assembly 1040a and the right frame assembly 1040b can be the same or substantially similar (e.g., symmetric). As shown, the left frame assembly 1040a can include a left flipper assembly 1048a fixed to a first side of the left frame. Also, the left frame assembly 1040a can include flag sensors 1060a, 1060b fixed 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 includes position sensing springs 1056a, 1056b that can contact a tissue interface 1058a. The tissue interface 1058a can be disposed 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 systems.

[0034] In some configurations, the right frame assembly 1040b may include flag sensors 1060c, 1060d fixed to the first side of the right frame. The flag sensors 1060c, 1060d can communicate with the position sensing linear slide 1054 and the position sensing flag 1062. Further, as shown, the right frame assembly 1040b can include a right flipper assembly 1048b fixed to the second side of the right frame. In some configurations, the right frame assembly 1040b includes position sensing springs 1056c, 1056d, which can contact the tissue interface 1058b. The tissue interface 1058b can be disposed on the third side of the right frame. In some configurations, the right frame assembly 1040b can be attached to a part of the vertical component assembly 1046 via screws and alignment pins.

[0035] The flipper assemblies 1048a, 1048b can include a flipper mounting block 1066 and a flipper motor 1068. In some configurations, the flipper mounting block 1066 may be constructed of a dielectric material. The flipper motor 1068 can be connected to (and control) the flipper driver pulleys 1070a, 1070b. A bearing (e.g., a thrust bearing) 1072 can support the axial load applied by a needle top plate (e.g., the needle top plate 1112 as described below) on the flipper 1074. The flipper 1074 can rotate in response to motor activation, 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 to each other. The main function of the flipper 1074 may be to hold the needle top plate 1112 of FIG. 4E in a fixed position when loading the needle retraction spring. And the flipper 1074 can move out of the path of the needle top plate 1112 during the rest of normal operation. In some configurations, the flipper mounting block 1066 can function as a guide for the solenoid plunger bar 1106 of FIG. 4E (e.g., to maintain proper alignment).

[0036] Further, referring to FIGS. 4A through 4E, and particularly FIG. 4D, further exemplary details of the horizontal component assembly 1044 are shown in several configurations. The horizontal component assembly can include sensors, actuators, and / or guides for positioning the horizontal carriage assembly 1082, and thereby can include hammers 1098a, 1098b (described below) used to move the microneedles into the tissue. In some configurations, a 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 configured to attach a horizontal motor 1050. In some configurations, a horizontal chassis 1084 can support the horizontal carriage assembly 1082. Additionally, the right frame assembly 1040b and the left frame assembly 1040a may be fixed to opposite sides of the horizontal chassis 1084, for example, using rivets. According to some configurations, a ground connection 1080 may be attached to the horizontal chassis 1084.

[0037] In some configurations, the horizontal component assembly 1044 can further include a retractable sliding door 1090. When the cartridge 2002 is not inserted into the engagement slot 1002, the sliding door 1090 can extend across the loading opening 1006. Thus, it is possible to prevent a user from placing something inside the handheld device 1000 when the cartridge 2002 is not present. The sliding door 1090 may be fixed to a sliding door attachment 1086, and the sliding door attachment 1086 may be fixed to the horizontal chassis 1084. Further, a sliding door spring 1088 can be fixed to the sliding door attachment 1086 and biased so that the sliding door 1090 is maintained in the "closed" position (i.e., extends across the loading opening 1006) when the cartridge is not loaded.

[0038] As shown, the horizontal carriage assembly 1082 can, in some configurations, include hammers 1098a, 1098b, corresponding hammer return springs 1092a, 1092b, and corresponding hammer guides 1094a, 1094b. Typically, 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 can be made of bronze, which can help maintain the bearing surface through a number of sampling and implantation cycles. Additionally, in some configurations, the hammers 1098a, 1098b can be made of hardened 17-4 stainless steel, which can provide excellent wear characteristics while maintaining corrosion resistance. Alternatively, the hammers 1098a, 1098b can be made of another bearing material. The horizontal carriage assembly 1082 can further include a horizontal lead screw drive nut 1096. Additionally, the horizontal lead screw assembly 1096 can be a Teflon-coated lead screw and an acetal drive nut designed to reduce friction. Alternatively, the horizontal lead screw drive assembly 1096 may include other types of materials. The horizontal lead screw drive assembly 1096 can provide an appropriate pitch for position resolution and linear force. Additionally, the horizontal carriage assembly 1082 can use motor stall to detect whether the cartridge is loaded or if there is a device jam.

[0039] Furthermore, referring to FIGS. 4A through 4E, and particularly FIG. 4E, further exemplary details of the vertical component assembly 1046 are shown in some configurations. 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 can include a vertical motor 1100, as well as associated release cams 1102a, 1102b and vertical lead screws 1104a, 1104b. In some configurations, the vertical position of the vertical carriage subassembly 1108 can be controlled by moving it up and down on the vertical lead screws 1104a, 1104b (e.g., using the vertical motor 1100). As will be described later, the vertical positioning can be used to move each of the micro needles corresponding to the cartridge 2002. Typically, the vertical component assembly 1046 can be configured to interface with and operate the cartridge 2002 and its associated components during tissue collection 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 necessary to operate the micro needle positions.

[0040] In some configurations, the solenoid 1052 can deliver an actuating force to the hammers 1098a, 1098b during collection. As one non-limiting example, the solenoid 1052 may be actuated by a half-wave of an AC current. The force delivered by the solenoid 1052 can increase rapidly towards 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 micro needle into the tissue. In some configurations, a stop (e.g., a brass stop) can be incorporated into the solenoid 1052, which can enable control of the extension of the solenoid plunger bar 1106 and absorption of the 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 an upper plate 1112. In some configurations, the 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 the maximum position of the needle retraction slide 1110. Additionally, a needle retraction spring 1120 is incorporated within the vertical carriage assembly 1108, whereby efficient retraction of the micro needle can be achieved on the pin. The needle retraction slide latches 1116a, 1116b can be used to lock the needle retraction slide 1110 downward in preparation for sampling. Also, the vertical carriage assembly 1108 can move both the needle and the pin (e.g., the pin within the micro needle) simultaneously.

[0042] In some configurations, the vertical carriage assembly 1108 can include a cartridge latch 1114, which can be configured to secure the cartridge 2002 when the cartridge 2002 is inserted into the loading opening 1006. Further, in some configurations, a vertical flag 1118 can be secured outside of the vertical carriage assembly 1108. As shown, the needle retraction slide 1110 can further include guide posts 1124a, 1124b, which 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, which can contact the guide posts 1124a, 1124b and is configured to engage and disengage with respect to the micro needle 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 downward (after being 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. Further, in some configurations, the lockdown latch 1126 can be configured to operate only after the skin grafting system 3000 has been initialized. Further details regarding the operation of the skin grafting system 3000 are described below.

[0043] Next, referring to FIGS. 5A through 5B, cartridges 2002 and cartridge assemblies 2000 according to several configurations are shown. As shown, cartridge assembly 2000 can include a cartridge 2002 and a cartridge cover 2004 that can be removably secured to a micro needle chamber 2018. The micro needle chamber 2018 can surround a plurality of micro needles 2006. In some configurations, the micro needles 2006 can be arranged as an array within the micro needle chamber 2018. As shown in FIG. 5A, the combination of the cartridge cover 2004 and the micro needle chamber 2018 can form an enclosure for the micro needles 2006. The cartridge cover 2004 can include release levers 2016a, 2016b, which may be simultaneously pressed by a user to remove the cartridge cover 2004 from the cartridge 2002. In some embodiments, the cartridge cover 2004 can latch onto a cartridge arm 2020 when the plurality of micro needles are in a specific position. The cartridge arm 2020 can prevent movement of the plurality of micro needles when the cartridge cover 2004 is secured to the cartridge 2002.

[0044] In some configurations, the cartridge 2002 can include a tissue stabilizer 2014, which can form a peripheral housing 2017 and be configured to stabilize tissue during collection. That is, the tissue stabilizer 2014 forms a peripheral housing 2017 that is wider than the micro needle chamber 2018, thereby allowing for a greater force distribution during use on the tissue of the skin grafting system 3000. 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 engagement slots 1002 during loading of the cartridge assembly 2000 into the loading opening 1006.

[0045] Next, referring to FIGS. 6A through 6C, a microneedle 2050 and a microneedle array 2006 according to the configuration of the present disclosure are shown. The microneedle 2050 can facilitate the collection of tissue from a donor site. In some configurations, the microneedle 2050 can include a hollow tube 2054, and the hollow tube 2054 can include a plurality of tip portions 2056 at its distal end. In some non-limiting examples, needle systems such as those described in U.S. Patent No. 9,060,803, U.S. Patent No. 9,827,006, U.S. Patent No. 9,895,162, and U.S. Patent Application No. 2015 / 0216545, U.S. Patent Application No. 2016 / 0015416, U.S. Patent Application No. 2018 / 0036029, U.S. Patent Application No. 2018 / 0140316, and / or combinations or components thereof can be used.

[0046] In some configurations of the present disclosure, the hollow tube 2054 can be provided with two tip portions 2056, and the tip portions 2056 are angled enough to penetrate and cut through biological tissue and remove small micrografts therefrom. Such a hollow tube 2054 can be provided with two tip portions 2056 and a "narrow heel" portion disposed between the two tip portions 2056. In some embodiments, the narrow heel portion can be sharpened so that a cutting edge corresponding to the hollow tube 2054 is created.

[0047] In some configurations, as shown in FIG. 6A, the hollow tube 2054 may be slidably attached to the substrate 2058 such that the hollow tube 2054 can pass through a hole provided 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 the longitudinal axis of the hollow tube 2054. In this way, the distance that the distal end of the hollow tube 2054 protrudes past the lower surface of the substrate 2058 can be controllably varied.

[0048] The microneedle 2050 can further include a pin 2052 provided in the 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, such that the hollow tube 2054 can be translated parallel along the axis corresponding to the pin 2052 with the pin 2052 filling or occluding most or all of the inner 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 to inhibit accumulation or attachment of biological material to the pin 2052. The distal end of the pin 2052 can be substantially flat, such that it is configured to facilitate shifting of tissue micro-grafts within the hollow tube 2054 when the hollow tube 2054 is translated parallel to the pin 2052.

[0049] The hollow tube 2054 can be translated parallel to the pin 2052, for example, substantially along the longitudinal axis of the hollow tube 2054. In this way, 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 changed. For example, the positions of the distal ends of both the hollow tube 2054 and the pin 2052 relative to the position of the lower surface of the substrate 2058 can be controllably and independently selected and changed.

[0050] FIG. 6B shows one configuration of the present disclosure, in which pin 2052 may be arranged with respect to hollow tube 2054 such that their distal ends are substantially aligned. In another configuration, pin 2052 may extend slightly beyond the distal end of hollow tube 2054, thereby protecting the sharp portion of hollow tube 2054 from unwanted contact with an object and / or the user. Optionally, a coating or surface treatment may be applied to a portion of pin 2052 and / or hollow tube 2054 to reduce friction between them and / or between any of the components or living 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 the configuration of the present disclosure. In some configurations, the microneedle array 2006 may be substantially circular. The microneedle array 2006 can be formed by aggregating multiple rows (horizontal rows or vertical rows) of needles. This design can be modular, and this configuration can take any shape or size using rows of various sizes as modules. In some configurations, all microneedles can be actuated (e.g., inserted into tissue) simultaneously. In other configurations, groups or sections can be actuated sequentially. For example, the microneedle array 2006 can be divided into quadrants, and each quadrant can be actuated sequentially. The expression "sequentially" 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 can be actuated separately and sequentially. Further, each single microneedle can be actuated separately and sequentially. In some configurations, one row can be actuated at a time, e.g., 20 rows can be actuated individually in sequence, while in other configurations, two, three, four, or more rows can be actuated at a time. The advantage of actuating the segments of the microneedle array 2006 sequentially is that inserting the segments may require less force on the donor site than inserting the entire microneedle array 2006. In some configurations, the microneedle array 2006 may be driven using a solenoid (e.g., solenoid 1052). By using multiple actuations of the solenoid, the insertions can be ordered row by row.

[0052] Next, referring to FIG. 7, some non-limiting examples of steps of a process 4000 for harvesting and implanting tissue according to the configuration 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 the 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 the cartridge assembly 2000. Further, the process 4000 is shown to include activating the harvesting mode (process block 4006). This activation can be initiated via the user interface 1008 according to some configurations as described below. Alternatively, the activation can be initiated via contact with the donor site. The process 4000 is shown to include applying a skin grafting system (e.g., the skin grafting system 3000) to the donor site (process block 4008). The donor site can correspond to a healthy area of the patient's tissue. Next, the process 4000 is shown to include starting the harvesting process (process block 4010). In some configurations, this start can occur via the trigger 1014 described above. The process 4000 is further shown to include removing the skin grafting system from the donor site (process block 4012). Next, the process 4000 is shown to include activating the implanting mode (process block 4014). In some configurations, this activation can occur via the user interface 1008 as will be described below. The process 4000 is further shown to include placing the skin grafting system above the recipient site (process block 4016). In some configurations, the recipient site can correspond to a damaged area of the patient's tissue.Next, process 4000 is shown to include initiating a planting process (process block 4018). In some configurations, this initiation can occur via the activation of trigger 1014 described above. As shown, process 4000 can end after the planting process (process block 4018), or can return to process block 4006 to restart the collection mode. In some configurations, a single cartridge (e.g., cartridge 2002) can be used multiple times on the same patient. Advantageously, when the recipient site is relatively large, multiple collections and plantings may be performed using a single cartridge. Thus, process 4000 can continue from process block 4006 to process block 4018 until the user is ready to discard the cartridge.

[0053] According to the configurations of the present disclosure, the collection process and the planting process can be performed using skin grafting system 3000. Accordingly, a non-limiting description of the internal functions of 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 power is supplied to the handheld device, the standby input 1018 may blink green when the handheld device 1000 is first powered on (e.g., for about 8 seconds at the first startup). This can inform the user that the handheld device 1000 is performing a startup self-test or other operations. 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 subsequent use. In some configurations, pressing the standby input 1018 for a predetermined time (e.g., 3 seconds, 5 seconds, etc.) can cause the handheld device 1000 to enter the standby mode. Continuing with the non-limiting example, the standby input 1018 can stop generating light when the handheld device 1000 is in the standby mode. Other bright colors, patterns, and timings 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 the acquisition mode but sufficient pressure on the donor site is not achieved during the skin graft process as described below. Further, the indicator light 1020 can generate a steady green light when the handheld device 1000 is in the acquisition mode and sufficient pressure on the donor site has been achieved (and the trigger 1014 has been disengaged). The indicator light 1020 can generate a blinking green light when the handheld device 1000 is in the acquisition process. When the pressure drops below the threshold during the acquisition process, the indicator light 1020 can generate a blinking white light. Further, the indicator light 1020 can generate a blinking 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 collection process is completed. In some configurations, pressing the planting input 1022 thereafter can cause the handheld device 1000 to enter the planting mode. The planting input 1022 can generate a steady green light when the handheld device 1000 is in the planting mode. Similar to the indicator light 1020, the planting input 1022 can generate a blinking white light when the handheld device 1000 is in a fault state. In some configurations, the planting input 1022 can generate a blinking white light during the collection process, which may indicate that extraction recovery is required. Pressing the planting input 1022 thereafter can start the extraction recovery process. When the extraction recovery process is completed, 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 the collection mode and sufficient pressure on the donor site has been achieved (and the trigger 1014 has been disengaged), an indicator light 1016 similar to the indicator light 1020 can generate a continuous green light. Additionally, in some configurations, the indicator light 1020 can generate a blinking green light during the collection process.

[0058] <Operating Positions of the Skin Transplantation System> In some configurations, a plurality of operating positions corresponding to the skin transplantation system 3000 can be defined. In particular, the skin transplantation 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 movable 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 can be aligned with corresponding components for loading or picking. This position can be below the vertical flag sensor occlusion point. As viewed by the user, 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 corresponding to a calibrated position, at which the needle retraction slides 1116a, 1116b are pushed above their respective unlock cams 1102a, 1102b, thereby unlocking the needle retraction slide 1110 by the vertical carriage assembly 1108. This can be the highest position at which the vertical carriage assembly 1108 moves. As viewed by the user, the vertical carriage assembly 1108 may appear to be above and 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 the respective position has been reached. The "flipper in" position, i.e., the retracted position, can correspond to the case where the flipper 1074 is safely away from the movable part. The "flipper out" position, i.e., the extended position, can correspond to the case where the flipper 1074 is obstructing the upper 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, at which the vertical carriage assembly 1108 can move (with the flipper 1074 extended) to compress the needle retraction spring 1120 and lock the needle retraction slide latch 1116. This "lock" is to lock the cartridge 2002 inside the handheld device 1000 and enable the needle to be retracted later.

[0064] Some configurations of the present disclosure include a vertical carriage lock relaxation position, which can be an offset position from the calibrated lock position, at which the properly locked upper plate 1112 of the needle retraction slide no longer applies pressure to the flipper 1074, and thus the flipper 1074 can be in a safe state to retract. Conversely, if the upper plate 1112 of the needle retraction slide is not properly locked, this position can be designed to continuously apply sufficient pressure to the flipper 1074 to prevent them from retracting. This position can enable 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 can be an offset position from the calibrated unlock position, at which the needle retraction slide 1110 is not unlocked and the extended needle can be behind the tissue stabilizer 2014. This position is where the vertical carriage assembly 1108 can extract the needle from the tissue (including the tissue graft) after collection and before implantation. Advantageously, since the needle remains extended, the tissue graft can be prevented from being exposed at this position.

[0066] Some configurations of the present disclosure include a collection recovery mode that can occur during the collection process. The collection recovery mode can include attempting to continue deploying the needle module into the tissue. Additionally, the collection recovery mode may be fully controlled automatically and by onboard software (i.e., no user interaction is required). In some embodiments, the collection recovery mode can include reversing the movement of the horizontal carriage assembly 1082 by a predetermined distance or time interval. Subsequently, the horizontal carriage assembly 1082 can move forward and attempt to deploy the needle module into the tissue again.

[0067] Some configurations of the present disclosure can include an extraction recovery mode that can occur after the needle has been deployed (and when the handheld device 1000 is attempting to return the horizontal carriage to its home position). In some configurations, the horizontal carriage assembly 1082 may become immobile due to increased friction from the needle module. If this occurs, the handheld device 1000 can blink the implantation light (on the implantation input 1022) white to indicate that extraction recovery is needed. Then the user can reduce the downward force on the tissue and press the implantation input 1022 to allow the handheld device 1000 to continue extracting the needle from the tissue.

[0068] <Vertical operation of skin graft assembly> In some configurations, the various components corresponding to the handheld device 1000 and the cartridge 2002 can have predetermined operations based on the current mode of the handheld device 1000 (e.g., initialization, collection mode, implantation mode, etc.).

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

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

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

[0072] In some configurations, the vertical component assembly 1046 can have a predefined "collection" configuration that corresponds to an applied user force. During the collection configuration, for example, the needle retraction slide 1110 can remain locked while a load is applied to the needle retraction spring 1120 and the needle is retracted. In some configurations, the vertical carriage assembly 1108 can remain in the collection position. When the user positions the skin grafting system 3000 at the donor site and applies a downward force, the user can detect that the tissue stabilizer 2014 moves slightly in a direction opposite to the applied force, thereby causing the indicator lights 1016 and 1020 to illuminate, indicating to the user that proper alignment for collection exists. 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 "collection" configuration that corresponds to needle deployment. During this collection configuration, for example, the solenoid plunger bar 1106 can advance, and the needle retraction slide 1110 can remain locked while a load is applied to the needle retraction spring 1120. In particular, the needles (e.g., from the micro needle array 2006) can be deployed into the tissue. In some configurations, the vertical carriage assembly 1108 can remain in the home position, and the user's force can still be applied via the handheld device 1000. When the user pulls the trigger 1014, the skin grafting assembly 3000 can initiate a collection sequence. Thus, the skin grafting assembly 3000 can advance each micro needle array row into the 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 "withdrawal" configuration. During the withdrawal configuration, for example, the solenoid plunger bar 1106 can be retracted, and the needle retraction slide 1110 can remain locked while loaded by the needle retraction spring 1120. The needles (e.g., from the micro needle array 2006) can remain deployed within the tissue at the start of withdrawal. The vertical carriage assembly 1108 can move to the withdrawal position (described above). In some configurations, after the collection is complete, the skin grafting system 3000 can withdraw the needles by lifting all the needles within the micro needle array 2006 at once. The needles can be lifted to the withdrawal position and the user's force can be removed. In some configurations, the needles can remain advanced relative to the pins (e.g., pin 2052), and the tissue stabilizer 2014 can remain stationary when the needles are retracted.

[0075] In some configurations, the vertical component assembly 1046 can have a predefined "impl antation" configuration. During the implantation configuration, for example, the needle retraction slide 1110 can be in the retracted position, at which time the needles are likewise in the retracted state. In some configurations, the vertical carriage assembly 1108 can move from the withdrawal position. When the user initiates the implantation sequence, the skin grafting system 3000 can move the vertical carriage assembly 1108 from the withdrawal position, thereby releasing the loaded needle retraction spring 1120 and the needle retraction slide 1110. Thus, this movement can retract the needles relative to the pins (e.g., pin 2052), and thus expose the graft and position the components for the implantation sequence.

[0076] In some configurations, the vertical component assembly 1046 can have a "planted" arrangement corresponding to the forward needle position. During this planted arrangement, for example, the solenoid plunger bar 1106 can advance, and the needle retraction slide 1110 can advance (similarly, the needle can advance). In some configurations, the solenoid plunger bar 1106 can advance and first hit the upper plate 1112, and then hit the needle module (e.g., within the micro needle array 2006). Thereby, the upper plate 1112 can be pushed forward of the needle carrier, and thus damage to the carrier can be prevented. The advancement of the needles, followed by the rapid retraction of these needles (by the unlocked upper plate 1112), can disperse the grafts to the recipient site.

[0077] <Power-on Self-Test> In some configurations, the handheld device 1000 can perform a self-test upon startup (e.g., when the handheld device 1000 is first powered on). In some configurations, the self-test can occur when the handheld device 100 is plugged in to receive power and the standby input 1018 is pressed and released. In some configurations, the standby input 1018 can blink green during the self-test. Next, the horizontal carriage assembly 1082 can move forward a very short distance such that the horizontal flag sensor 1064 is cleared. Thereafter, the horizontal carriage assembly 1082 can return to the home position.

[0078] During the self-test, the vertical carriage assembly 1108 can move upward a very small distance such that the vertical flag 1118 clears the sensor. Thereafter, the vertical carriage assembly 1108 can return to the home position. In some configurations, the vertical carriage assembly 1108 can move upward to an unlocked position where the needle retract slide latch 1116 can be moved before returning to the home position. This allows, for example, the needle retract slide 1110 to be released when the needle retract slide 1110 is locked (e.g., when the cartridge 2002 is locked inside).

[0079] In some configurations, the horizontal carriage assembly 1082 can move to a predetermined position (e.g., about two-thirds of the way along its full range) to confirm the absence of a cartridge (e.g., cartridge 2002). Thereafter, the horizontal carriage assembly 1082 can return to the home position.

[0080] During the self-test, the flipper 1074 can extend and then retract back. Further, in some configurations, some or all of the lights on the handheld device 1000 can blink (e.g., indicator lights 1016, 1020, planting input 1022, etc.). When the self-test is complete, the standby input 1018 can, for example, light up continuously green to indicate 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. The 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 to the cartridge 2002. Thereafter, the user can remove the cartridge cover 2004 and close the loading door 1004, thereby activating the internal loading door switch.

[0082] The initialization process can further include moving the horizontal carriage assembly 1082 from the home position, whereby the horizontal carriage assembly 1082 can detect the presence of the cartridge by stalling on the first cartridge segment. Thereafter, the horizontal carriage assembly 1082 can return to the home position. Additionally, the vertical carriage assembly 1108 can move a small amount such that the vertical flag 1118 clears the sensor, and then the vertical carriage assembly 1108 can return to the home position.

[0083] In some configurations, the flipper 1074 can extend outwardly above the upper plate 1112. The vertical carriage assembly 1108 can be moved to a locked position. When moving to the locked position, the flipper 1074 can hold the upper plate 1112 in place while the needle retraction slide latch 1116 moves outwardly, and ultimately can lock over the upper plate 1112. Accordingly, the needle retraction spring 1120 can be held in a compressed state. While this is occurring, for example, the lockdown latch 1126 can spring out below the needle segment (e.g., within the micro needle array 2006) to lock the needle segment downward during the collection sequence. In some configurations, the vertical carriage assembly can then move slightly downward, and thus can move to the unlock position (described above). Further, the flipper 1074 can retract and return inwardly.

[0084] The initialization process can further include returning the vertical carriage assembly 1108 to the collection position. The horizontal carriage assembly 1082 can contact the first needle segment and stall, and then can engage the first needle segment (within the micro needle array 2006) by moving backward a small predetermined distance. Next, the handheld device 1000 can calculate the position of each needle segment. When the initialization process is complete, the indicator light 1020 can turn white to indicate that the handheld device 1000 is ready for the collection sequence.

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

[0086] When the trigger 1014 becomes active, the user can pull the trigger 1014 (while maintaining the force applied to the skin), and the handheld device 1000 can start the collection sequence. In some configurations, indicator lights 1016, 1020 can blink green during the collection and extraction period. To ensure that sufficient force is maintained, the position sensing flag 1062 can be monitored during collection (while the solenoid is actuated). The solenoid 1052 can rapidly advance the solenoid plunger bar 1106, thereby advancing the two hammers 1098a, 1098b and inserting the first needle module into the tissue. The needle module, when inserted, moves through the needle module lock-down latch. Thereafter, the solenoid 1052 and the hammers 1098a, 1098b can retract, and the needle segment can remain locked down within 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 may be recalculated or otherwise re-verified through the sampling process. The solenoid 1052 can rapidly advance the solenoid plunger bar 1106, thereby advancing the two hammers 1098a, 1098b and inserting the next needle module into the tissue. The needle module, once inserted, can move through the lockdown latch 1126. The lockdown latch 1126 can spring 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 the 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, 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. Further, the implantation input 1022 can light up white, indicating that the handheld device 1000 is ready to proceed with the implantation process. When the sampling process is complete, the user can remove the force applied to the tissue and lift the handheld device 1000 away.

[0089] <Method of implantation> In some configurations, the user can implant the tissue column after the harvesting process. When 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., inside the tissue stabilizer 2014). With the recipient site prepared for the tissue column, the user can activate the implantation mode by pressing the implantation input 1022. In some configurations, the implantation input 1022 can change from white illumination to green illumination.

[0090] In some configurations, the user can place the cartridge 2002 directly above the recipient site. Then, the user can pull the trigger 1014, and the vertical carriage assembly 1108 can move from the extraction position, thereby releasing the needle retraction slide 1110 and retracting the needle behind a pin (e.g., pin 2052). The handheld device 1000 can rapidly advance the solenoid plunger bar 1106, in response to which both the needle retraction slide 1110 and the needle module are pushed. The needle retraction slide 1110 can be kept pushed in front of the needle module to prevent damage to the needle module. Subsequently, the solenoid plunger bar 1106 can retract, thereby retracting the needle retraction slide 1110 (pulling the needle module backward with the needle retraction slide 1110). The process of rapidly advancing the solenoid plunger bar 1106 can be repeated several times, thereby ensuring that as many grafts as possible are placed within the recipient site. In some configurations, the solenoid 1052 can be actuated 6 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 completes the collection and implantation 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 wants to complete another collection with the same cartridge 2002, the user can open and close the loading door 1004 (i.e., the cartridge 2002 is not removed). Thereby, another initialization process can be started via the handheld device 1000. Alternatively, the user can start another initialization process via an input (not shown) on the user interface 1008.

[0092] <Fluid ingress protection> As described 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 then discarded. In some cases, local bleeding may occur due to repeated tissue punctures through the microneedle array 2006. Additionally, blood dispersion may occur by repeatedly deploying and retracting the needle module. Since the cartridge 2002 can be disposable, for example, blood dispersion onto the outside of the microneedle chamber 2018 may not be as critical. 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 enters the housing 1036, extensive cleaning and disinfection processes may be required.

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

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

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

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

[0097] In some embodiments, the device cover 5000 can be a flexible polymer sheet. The flexible polymer sheet may be continuous in some embodiments. The device cover 5000 may also be of various other colors, such as white, black, blue, etc. In particular, the color of the device cover 5000 can be selected to visually highlight the position 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 of a white, blue, yellow, or other color that is significantly different from dark red blood so as to highlight the position 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 size of the access opening 5004 can be such that a user can hold the handheld device 1000 and interact with corresponding elements (such as the user interface 1008, trigger 1014, loading door 1004, etc.) during the skin grafting process. Further, in some configurations, the size of the access opening 5004 can be such that the handheld device 1000 can be accommodated within the internal volume 5006 of the device cover 5000. Further, the size of the internal volume 5006 can be such that a user can interact with the elements of the handheld device 1000 during the skin grafting process. As an example, the internal volume 5006 can provide for the opening and closing of the loading door 1004 that can initiate the above-described initialization process. As another example, the internal volume 5006 can provide for user interaction with the user interface device 1000.

[0099] As shown in FIG. 8A, the cartridge opening 5002 is capable of contacting a band portion (e.g., gasket assembly 6000). Usually, the gasket assembly 6000 can be fixed to the outer periphery of the cartridge opening 5002 and can contact the outer portion of the cartridge 2002. The gasket assembly 6000 will be described in more detail below with respect to FIGS. 10 to 13B.

[0100] Referring particularly to FIGS. 9A to 9B, an apparatus cover 5000 according to some embodiments of the present disclosure is shown. As shown, the access opening 5004 can include means for restricting the size of the access opening 5004. As an example, FIGS. 9A to 9B are shown to include an elastic band 5008 as means for restricting the size of the access opening 5004. The elastic band 5008 can be stretched to provide insertion into the internal volume 5006 of the handheld device 1000. Conversely, the elastic band 5008 can contract to reduce the size of the access opening 5004 so that the user can still grip the handheld device 1000 through the access opening 5004, but the smaller opening prevents clinical contaminants from entering the internal volume 5006 during the skin grafting process. The elastic band 5008 can be sewn or attached by an adhesive along the outer 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 and prevent the ingress of clinical contaminants.

[0101] Referring mainly to FIGS. 10 through 13C, a gasket assembly (e.g., gasket assembly 6000) according to an embodiment of the present disclosure is shown. The gasket assembly can prevent clinically contaminated substances from contacting the handheld device through the cartridge opening 5002. In some embodiments, the gasket assembly 6000 may 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 may be disposed between the gasket case lower portion 6002 and the gasket case upper portion 6006. In some embodiments, the gasket 6004 can be fixed 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 may be joined to each other via an adhesive and / or an internal engagement portion.

[0102] Referring particularly to FIGS. 11A through 11C, the 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 of the gasket case lower portion 6002, FIG. 11B provides a rear view, and FIG. 11C provides a side view. 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 toward the skin graft system 3000).

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

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

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

[0106] Next, referring to FIGS. 12A through 12B, a gasket 6004 according to an embodiment of the present disclosure is shown. 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 the 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 may 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 function as a barrier. The cartridge 2002 can be inserted into the gasket opening 6024, thereby pressing the gasket 6004 against the outside of the cartridge 2002 (e.g., the tissue stabilizer 2014). Accordingly, the gasket 6004 can form a seal with the cartridge 2002 that can prevent clinical contaminants from entering the handheld device 1000 during the skin grafting process.

[0108] Next, referring to FIGS. 13A through 13B, a gasket case upper portion 6006 according to an embodiment of the present disclosure is shown. In particular, FIG. 13A is a rear view of the gasket case upper portion 6006, and FIG. 13B is a side view of the gasket case upper portion 6006. In some embodiments, the gasket case upper portion 6006 can include a distal side 6066 (e.g., disposed away from the skin grafting system 3000) and a proximal side 6064 (e.g., disposed toward the skin grafting system 3000).

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

[0110] As shown in FIG. 13A, the upper gasket case 6006 may include a raised portion 6062 and a recessed portion 6060 disposed between an outer edge 6052 and a retainer edge 6056. In some embodiments, the raised portion 6062 and the recessed portion 6060 can be arranged such that the upper gasket case 6006 can be press-fitted and held in the lower gasket case 6002. In some embodiments, for example, the raised portion 6062 of the upper gasket case 6006 may be complementary (e.g., aligned, of similar dimensions, etc.) to the recessed portion 6018 of the lower gasket case 6002. Similarly, the recessed portion 6060 of the upper gasket case 6006 may be complementary (e.g., aligned, of similar size, etc.) to the raised portion 6016 of the lower gasket case 6002. As described above, an adhesive can be disposed between the upper gasket case 6006 and the lower gasket case 6002 to further maintain the structure of the gasket assembly 6000. In some embodiments, the upper gasket case 6006 may include an engagement surface 6068 that protrudes from a proximal side 6064. The engagement surface 6068 can be configured to be inserted into the lower gasket case 6002, thereby helping to maintain the overall structure of the gasket assembly 6000.

[0111] In some embodiments, the gasket case upper portion 6006 and / or the gasket case lower portion 6002 can be fixed to the outer periphery of the cartridge opening 5002 (i.e., corresponding to the device cover 5000). Further, a portion of the device cover 5000 adjacent to the cartridge opening 5002 can be pressed between the gasket case upper portion 6006 and the gasket case lower portion 6002 so that the gasket assembly 6000 is fixed to the outer periphery. In some embodiments, the gasket case upper portion 6006 may be fixed to the outer portion of the device cover 5000 using an adhesive. Similarly, the gasket case lower portion 6002 may be fixed to the inside of the device cover 5000 using an adhesive. As described above, an adhesive can be further used to couple the gasket case upper portion 6006 to the gasket case lower portion 6002. Thus, the gasket 6004 can be positioned and held between the gasket case lower portion 6002 and the gasket case upper portion 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 the device cover 5000 can suppress the ingress of fluid (e.g., clinical contamination) into the internal volume 5006 of the device cover during the skin grafting process. Thereby, the user's ability to reuse the handheld device 1000 without performing a potentially long internal component sterilization process can be maintained.

[0112] Referring mainly to FIGS. 14A through 14E, another band (e.g., gasket assembly 7000) according to an embodiment of the present disclosure is shown. The gasket assembly can prevent clinical contaminants from contacting the handheld device through the cartridge opening 5002. According to some embodiments, the gasket assembly 7000 may be substantially integral (e.g., manufactured as a single component). Alternatively, the gasket assembly 7000 can include removably fixed portions. In some embodiments, the gasket assembly 7000 may be formed as part of the cartridge 2002 (i.e., manufactured as a single component). Further, in some embodiments, the device cover 5000 may be directly fixed to the cartridge 2002 (e.g., via an adhesive, welding, etc.), thus forming a single component in this way.

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

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

[0115] Gasket assembly 7000 is shown as including a protrusion 7012 that can include an inner edge 7010 and an outer edge 7020. Protrusion 7012 can help secure cartridge 2002 when inserted into opening 7016. Protrusion 7012 can contact cartridge 2002 via inner edge 7010 and a proximal edge in some embodiments. Referring particularly to FIGS. 14B, 14D, and 14E, proximal side 7004 is shown as including notches 7008a, 7008b that can recess with respect to protrusion 7012. As shown, notches 7008a, 7008b can be sized to provide an extended position for cartridge arms 2020 (e.g., see FIGS. 1 and 5B).

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

[0117] As described above, the band portion (e.g., gasket assembly 7000) and the device cover 5000 can suppress the intrusion of fluid (e.g., clinical soiling) into the internal volume 5006 of the device cover during the skin grafting process. Thereby, the user's ability to reuse the handheld device 1000 without performing a sterilization process on the internal components, which can be time-consuming, can be maintained.

[0118] Next, referring to FIGS. 15A through 15C, an absorbent material 8000 according to an embodiment of the present disclosure is shown. Specifically, FIG. 15A is a top view of the absorbent material 8000 corresponding to the clinical soiling control system, FIG. 15B is a top view of the absorbent material 8000 disposed within the tissue stabilizer 2014, and FIG. 15C is a perspective view of the absorbent material 8000 disposed around the microneedle array 2006. In particular, in some embodiments, a repellent material (e.g., a hydrophobic material) can be used instead of the absorbent material 8000. The repellent can function as a barrier around the microneedle array 2006 and thus deflect clinical soiling away from the interior of the handheld device 1000.

[0119] In some embodiments, the absorbent material 8000 can suppress the intrusion of fluid (e.g., clinical soiling) 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 fluid (e.g., fluid from the skin grafting process). Further, in some embodiments, the absorbent material 8000 can include hydrophilic fibers that can absorb and retain fluid. As an example, the absorbent material 8000 may have substantially the same properties as Qwick™, an absorbent wound dressing commercially available from Medline Industries, Inc.

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

[0121] As shown in FIGS. 15A through 15C, the absorbent material 8000 may be cut to complement the size and shape of the tissue stabilizer 2014 and the micro needle chamber 2018. In some embodiments, the absorbent material 8000 can include an inner edge 8002 and an outer edge 8006. The inner edge 8002 can be positioned to be substantially aligned with an opening of the tissue stabilizer 2014 (e.g., an edge of the micro needle chamber 2018). The outer edge 8006 can be disposed on the inner wall of the tissue stabilizer 2014. In some embodiments, the absorbent material 8000 can be fixed to the inner surface of the tissue stabilizer 2014 using an adhesive. The adhesive can prevent movement of the absorbent material 8000 during the skin grafting process. For example, by fixing the absorbent material 8000 within the tissue stabilizer 2014, movement of the micro needles 2050 can be prevented from being hindered by the absorbent material 8000 during harvesting and / or implantation. In some embodiments, the adhesive can be in the form of a liquid or a film. Further, the absorbent material 8000 can be fixed to the inner surface of the tissue stabilizer 2014 via various welding methods such as RF welding. Other mechanical methods, for example, for fixing the absorbent material 8000 to the tissue stabilizer 2014 may be used.

[0122] The absorbent material 8000 can include various cutouts 8004 to provide the features of the tissue stabilizer 2014. In particular, the cutouts 8004 may be arranged to provide clearance for the cartridge arm 2020 (as illustrated and described with respect to FIGS. 1 and 5B). In particular, the inner edge 8002 of the absorbent material 8000 may be coplanar with the edge of the micro needle chamber 2018, whereby fluid coming from the micro needles 2050 can be absorbed and maintained by the absorbent material 8000. Thus, the absorbent material 8000 can suppress the intrusion of fluid (e.g., clinical soiling) into the interior of the handheld device 1000 during the skin grafting process.

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

[0124] FIGS. 16A through 16E show a clinical soiling control system without a gasket assembly. The clinical soiling 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 part or all of the handheld device 1000. The access opening 9003 is sized to receive the handheld device 1000 within the interior volume 9006 of the device cover 9000 and further to allow the user to hold and interact with the corresponding elements of the handheld device 1000. As an example, the interior volume 9006 can provide for the opening and closing of the loading door 1004 that can initiate the initialization process described above. The device cover 9000 may 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 receive the cartridge 2002. In particular, the cartridge opening 9002 can receive the peripheral housing 2017 formed by the tissue stabilizer 2014. The cartridge opening 9002 may include a protrusion 9004 that forms the cartridge opening 9002. The protrusion 9004 can extend in a direction away from the internal volume 9006 of the device cover 9000 to the same or a length shorter than or longer than the length in which the peripheral housing 2017 extends away from the main body of the cartridge 2002. The protrusion 9004 has an inner surface 9010 that extends around the inner circumference of the protrusion 9004. In some embodiments, the protrusion 9004 may be made of the same or a similar material as the main 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, when the peripheral housing 2017 is in the shape of a quadrangular prism as shown in FIGS. 16A to 16E, the inner surface 9010 and the cartridge opening 9002 can be shaped to contact the outer surface of substantially the same quadrangular prism. The inner surface 9010 of the peripheral housing 2017, the cartridge opening 9002, and the protrusion 9004 can also be formed in other combinations of complementary shapes, 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 the ingress of fluid into the housing 1036 via the tissue stabilizer 2014. 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 above the cartridge 2002 to create a sealed seal that prevents the ingress of fluid. Thus, the device cover 9000 is a band through 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 (see, e.g., FIG. 16D) for firmly but removably attaching the protrusion 9004 to the cartridge 2002. The elastic loop 9014 can be integrally formed on or separately attached to the outside of the protrusion 9004 at any location 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. The absorbent material 8000 (described above) can be disposed on the inner surface 9010, within the tissue stabilizer 2014, or both. 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 stain control system can prevent the ingress of fluid 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). This can maintain the user's ability to reuse the handheld device 1000 without performing a potentially time-consuming sterilization process on the internal components.

[0129] Although 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 present disclosure is not intended to be limited to the particular forms disclosed. Rather, the present disclosure covers all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the following appended claims.

[0130] In this specification, examples have been used to disclose the present disclosure, including the best mode, and this specification also enables the implementation of the present disclosure by those skilled in the art, which includes the making and using of any apparatus or system and the execution of any incorporated technology. The patentable scope of the present disclosure is defined by the claims and may include other examples that occur to those skilled in the art. Such other examples are considered to be within the scope of the claims if the components are not different from those described in the claims or if they include equivalent components that are not significantly different from those described in the claims.

[0131] Finally, it is obvious that any of the processes or steps described in this specification can be combined, excluded, or the order can be changed. Therefore, this specification should be construed as illustrative only and not as limiting 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 handheld device 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 microneedles.

14. The skin graft system of claim 12 , wherein the absorbent material surrounds the plurality of 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 polymer sheet defining an interior volume for a skin grafting device, the device cover including at least a first opening configured to receive a portion of the skin grafting 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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