Tissue removal devices and methods

Abstract

Devices, methods, and kits can be designed and used for tissue removal. In some examples, a tissue removal device includes a handle assembly, a rechargeable battery, a motor system with a reciprocating motor shaft electrically coupled to the rechargeable battery, and a head assembly releasably coupled to the handle assembly. The head assembly can include a blade. The blade can be configured for linear movement that is transverse to a longitudinal axis of the handle assembly and responsive to a movement of the reciprocating motor shaft.

Description

[0001] Tissue Removal Devices and Methods

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefit of U.S. Provisional Application Serial No. 63 / 539,495 filed September 20, 2023. The disclosure of the prior application is considered part of (and is incorporated by reference in) the disclosure of this application.

[0004] TECHNICAL FIELD

[0005] This document relates to devices, methods, and kits for performing de- epithelialization and / or skin harvesting. For example, this disclosure relates to devices, methods, and kits that include an oscillating blade and stabilizer for performing surgical tissue de-epithelialization or skin harvesting with consistent, predictable, repeatable, and productive results.

[0006] BACKGROUND INFORMATION

[0007] De-epithelialization and tissue harvesting are surgical procedures by which the epidermis (top layer) is removed from the rest of the skin. Techniques for de-epithelization involve manually superficially scoring the skin with a scalpel and removing strips of epidermis between the scored outline with a sharp scissors or a scalpel. De-epithelialization can be used to address various conditions, including skin cancer treatment, scar revision, tattoo removal, and reduction mammoplasty. Tissue harvesting is performed for various reasons including the treatment of large skin injuries such as burns. Techniques for de- epithelization include the use of a dermatome to remove large sections of epidermis. By removing the epithelial layer, the procedure promotes healing, enhances the aesthetic appearance of the skin, and allows for the successful integration of a skin graft in the case of harvesting.

[0008] SUMMARY

[0009] This disclosure describes devices, methods, and kits for the procedures of de- epithelialization and tissue harvesting. De-epithelialization focuses on the targeted removal of the epidermis to facilitate the regeneration of new skin from the underlying dermis. This technique finds application in diverse surgical procedures, such as reduction mammoplasty, scar revision surgery, flap reconstruction, and injury repair.

[0010] The existing technology for de-epithelialization and tissue harvesting exhibits notable disadvantages. The procedures are costly, due to their labor-intensive nature and the need for skilled assistants (e.g., another surgeon) alongside the surgeon removing the tissue. Moreover, the process is time-consuming, demanding precision and concentration while manipulating forceps and scalpels. The labor-intensive and time-consuming nature of the current procedures can lead to imprecise removal of tissue (e.g., inconsistent depth of removal) resulting in detrimental consequences for a subject (e.g., a patient). Incomplete or shallow removal may give rise to complications such as the formation of epidermal cysts. If the removal is too deep, surgical repair of the dermis can be needed to maintain an intact dermal layer which preserves structures (e.g., blood supply) and promotes healing. Furthermore, the inconsistent removal of tissue can impede proper healing at the donor site (e.g., in the case of skin grafts), diminish the functionality of the healed skin, yield unpredictable aesthetic outcomes, and jeopardize the survival of skin grafts. These shortcomings underscore the pressing need for improved technology in de-epithelialization and tissue harvesting devices and procedures. The improved tissue removal devices disclosed herein aim to address significant problems in the field of precise tissue removal that remain unmet by current technology.

[0011] Embodiments of the improved devices, methods, and kits described in this disclosure can provide one or more of the following advantages. First, embodiments described herein disclose an improved tissue removal device that can be operated absent the need of an assistant. This reduction in personnel can lower the overall expenses associated with the surgical procedure and increase efficiency by decreasing coordination with additional personnel. Further, performing the procedure with less personnel allows the surgeon to have direct control over process. This can result in improved precision and accuracy in the removal of tissue. The surgeon can maintain control over the angle, pressure, and speed of the device, facilitating an improved outcome.

[0012] Second, embodiments of the improved tissue removal device include a motor that facilitates the cutting of tissue. The battery powered motor system and is configured to convert rotational motion to linear-reciprocating motion (e.g., a rotary motor or an oscillating motor). The rotational motion generated by the motor is converted into linear-reciprocating motion through a linkage system or a crankshaft mechanism. For example, the rotary motor drives the cutting blade in a back-and-forth motion to achieve tissue removal. The motor decreases manual cutting which decreases personal and gives the surgeon more control of tissue removal.

[0013] The advantage of using this type of motor in a tissue removal device is that it provides the linear motion for improved accuracy in tissue removal. The motor's ability to convert rotational motion to linear-reciprocating motion allows for rapid and steady movement of the cutting element, improving efficient cutting and reducing the risk of inconsistent tissue removal.

[0014] Third, embodiments of the improved tissue removal device include a window assembly at the blade surface and disposable guards that provide tissue stabilization and direct views of the blade / tissue interface while allowing for epidermal tissue collection. The window assembly allows the user (e.g., a surgeon) to view the removal of the tissue and make real-time adjustments for precise removal of the intended tissue. By having a direct view of the surgical site, the surgeon can assess the depth, angle, and extent of tissue removal, improving accuracy and minimizing the risk of incomplete, inconsistent, or excessive removal.

[0015] Fourth, embodiments of the tissue removal device include a design to increase visibility and control as the device is pulled across the tissue of a subject toward the surgeon. A surgeon pulling the tissue removal device in a direction that is toward his / her body offers enhanced sensory feedback as the surgeon’s hand is moving closer to his / her body. This proximity provides improved proprioception and tactile sensation, allowing the surgeon to sense the amount of pressure being applied and make real-time adjustments. Pushing a tissue removal device away from a user’s body (as is done in previous manual procedures) creates a larger distance between the surgeon’s hand and his / her body. This can diminish the sensitivity to subtle changes in pressure and potentially compromise the ability to maintain a more consistent force as compared to pulling the device toward their body. Additionally, pushing a tissue removal device away from a user’s body may require the use of an assistant to stabilize the tissue, and can cause the cutting device to jump or skip across the skin surface leading to an inconsistent cutting depth. Further, a surgeon pulling the tissue removal device toward their body during the surgical tissue removal process provides a line of sight that is aligned with the tissue removal device and tissue being removed, providing direct visual feedback. This alignment facilitates improved visualization of the tissue interface with the blade and allows for precise adjustments in pressure. Pushing the device away creates a misalignment between the surgeon’s line of sight and the area of tissue being manipulated, potentially decreasing accurate visual assessment and the ability to apply more consistent pressure.

[0016] Fourth, embodiments of the tissue removal device include kits that comprise multiple disposable heads of varying sizes and widths. The availability of interchangeable disposable heads allows a surgeon to select the most suitable size for the specific tissue removal needs during a surgical procedure. Different anatomical regions or varying patient anatomies can necessitate different head sizes for optimal results. The ability to remove and replace head assemblies’ mid-surgery provides flexibility and adaptability, enabling the surgeon to customize the procedure according to individual patient characteristics. Further, sterile disposable heads provide a high level of hygiene and infection control. By using a new disposable head for a procedure or patient, the risk of cross-contamination or the transmission of infectious agents between patients is significantly reduced. This sterile approach aligns with best practices for maintaining a sterile surgical environment and minimizing the potential for postoperative complications. Additionally, the use of interchangeable disposable heads in a surgical setting enhances safety by decreases the exposure of the blade during head assembly changes. This reduces the risk of accidental cuts or injuries to the surgical team since the blade remains safely concealed within the disposable head, decreasing the potential for mishandling or accidental contact.

[0017] Fifth, embodiments of the tissue removal device include kits that comprise a stabilizer. The use of a stabilizer in tandem with a tissue removal device can be beneficial in addressing the unpredictability of tissue stability during harvesting or de-epithelization procedures. Soft tissues can be inherently mobile and subject to movement during surgical procedures, making it challenging to maintain a consistent contact and control with the tissue removal device. By employing a stabilizer, such as an external support or fixation device, the surgeon can immobilize or secure the surrounding soft tissue. This enhanced stability minimizes unintended movement, allowing for more precise and controlled tissue removal. The implementation of a stabilizer decreases personal, resulting in improved visual acuity and reduced obstruction caused by additional hands in the surgical field. With a stabilizer in place, the surgeon has better visibility of the operative site, leading to enhanced precision, control, and accuracy during tissue removal, while minimizing potential distractions or interference caused by additional personnel.

[0018] In one aspect, a tissue removal device includes a handle assembly, comprising a rechargeable battery, a motor system comprising a reciprocating motor shaft electrically coupled to the rechargeable battery, and a head assembly releasably coupled to the handle assembly, the head assembly comprising a blade, where the blade is configured for linear movement that is transverse to a longitudinal axis of the handle assembly and responsive to a movement of the reciprocating motor shaft.

[0019] In some embodiments, the blade is configured to remove tissue at a predetermined depth respective to a dermal layer of the tissue. In some embodiments, the head assembly comprises a motion plate configured to couple to the handle assembly and the reciprocating motor shaft, where the motion plate and the reciprocating motor shaft are configured to convert a rotational motion of the reciprocating motor shaft to linear-reciprocating motion of the motion plate. In some embodiments, the tissue removal device can include a window assembly that is configured to be removably couplable to the head assembly and the handle assembly. In some embodiments, the window assembly is configured to couple to the motion plate and the blade. In some embodiments, the head assembly and the window assembly are disposable.

[0020] In another aspect, a tissue removal device, includes a handle assembly, comprising a rechargeable battery, and a motor system comprising a reciprocating motor shaft electrically coupled to the rechargeable battery; a window assembly including a motion plate coupled to the reciprocating motor shaft, and a window blade support coupled to the motion plate, where the motion plate and the reciprocal motor shaft are configured to convert a rotational motion of the reciprocating motor shaft to linear-reciprocating motion of the motion plate, and a head assembly, releasably coupled to the window assembly, the head assembly comprising a blade coupled to the window blade support and configured for linear movement responsive to the linear-reciprocating motion of the motion plate, where the blade is configured to remove tissue at a predetermined depth respective to a dermal layer of the tissue. In some embodiments, the tissue removal device can include a stabilization device. In some embodiments, the stabilization device is a surface guard removably coupled to the head assembly. In some embodiments, the surface guard is transparent and coupled to the head assembly such that the surface guard distributes force to the tissue being removed. In some embodiments, the stabilization device is a counter roller interface plate removably coupled to the head assembly. In some embodiments, the counter roller interface plate comprises rollers configured to rotate counter to a cutting direction. In some embodiments, the stabilization device includes a stabilization window where the tissue removal device is positioned. In some embodiments, the stabilization device is not coupled to the tissue removal device. In some embodiments, the stabilization device comprises a gasket tissue interface that is configured to apply suction to the tissue. In some embodiments, the window blade support includes a first side and a second side with a void therebetween. In some embodiments, the void provides a view of the tissue that is to be removed by the blade. In some embodiments, the tissue removal device includes a sharp portion of the blade is positioned in a same direction as a motion of the handle assembly. In some embodiments, a blade guard coupled to the head assembly. In some embodiments, the blade is positioned at a predetermined angle to remove the tissue at the predetermined depth.

[0021] In another aspect, this document discloses a method of removing tissue from a subject, the method includes selecting an area of tissue of the subject, configuring a tissue removal device to remove tissue from the selected area of the subject at a predetermined depth, positioning the tissue removal device on the tissue in the selected area, and pulling the tissue removal device in a direction that is toward a user. In some embodiments, the tissue removal is performed during a de-epithelization procedure. In some embodiments, the tissue removal is performed during a tissue harvesting procedure. In some embodiments, the tissue removed is an epidermal layer of the tissue. In some embodiments, method further includes detaching a first head assembly from a handle assembly of the tissue removal device; and attaching a second head assembly to the handle assembly of the tissue removal device. In some embodiments, the method further comprises removing additional tissue using the second head assembly. In another aspect, this document discloses a kit for a tissue removal device. In some embodiments, the kit includes one or more head assemblies, one or more window assemblies; and one or more stabilization devices.

[0022] In some embodiments, the one or more head assemblies include a head assembly with a scalpel attachment, a head assembly with an open blade attachment, a head assembly with a blade for a de-epithelization procedure, or a head assembly for a tissue harvesting procedure. In some embodiments, the one or more head assemblies are disposable. In some embodiments, a handle assembly with a rechargeable battery and motor. In some embodiments, the handle assembly is couplable to the one or more head assemblies. In some embodiments, the handle assembly is couplable to the one or more window assemblies. In some embodiments, the one or more window assemblies are couplable to the one or more head assemblies. In some embodiments, the one or more stabilization devices include a tissue stabilization device, a counter roller interface plate, or a surface guard.

[0023] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure pertains. Although methods and materials similar or equivalent to those described herein can be used to practice the methods, kits and devices, suitable methods and materials are described below. All publications, patent applications, patents, and other references mentioned herein are incorporated by reference in their entirety. In case of conflict, the present specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and not intended to be limiting.

[0024] The details of one or more examples of the methods, kits and devices are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the methods, kits and devices will be apparent from the description and drawings, and from the claims.

[0025] DESCRIPTION OF THE DRAWINGS

[0026] FIG. 1A depicts an example tissue removal device with a head assembly, a handle assembly, and a window assembly.

[0027] FIG. IB depicts an exploded view of the tissue removal device of FIG. 1A. FIG. 1C depicts an exploded view of another design variation of the tissue removal device of FIG. 1A.

[0028] FIG. 2A depicts a side perspective view of an example tissue removal device with a surface guard.

[0029] FIG. 2B depicts a top-down view of the example tissue removal device of FIG. 2A.

[0030] FIG. 3 depicts a perspective view of an example tissue removal device with a counter roller interface plate.

[0031] FIG. 4 is a bottom-up view of an example tissue removal device with a blade guard.

[0032] FIG. 5 is another example tissue removal device with an open blade attachment.

[0033] FIG. 6 is another example tissue removal device with a scalpel attachment.

[0034] FIG. 7 is an example stabilization device for use with a tissue removal device.

[0035] FIG. 8 is an example tissue removal device paired with the stabilization device of FIG. 7.

[0036] FIG. 9 is an example kit that includes a handle assembly, interchangeable head assemblies, a stabilization device, and a window assembly.

[0037] FIG. 10 is an example method for tissue removal according to the disclosure.

[0038] DETAILED DESCRIPTION

[0039] FIGS. 1A and IB show an example tissue removal device 100. The tissue removal device 100 is designed to increase visibility and control as a clinician operator pulls the device 100 across the tissue of a subject toward the clinician operator to perform surgical tissue de-epithelialization or skin harvesting with consistent, predictable, repeatable, and productive results.

[0040] FIG. 1 A illustrates the tissue removal device 100 in its assembled configuration. FIG. IB illustrates the tissue removal device 100 in an exploded view for enhanced visualization and understanding of the components of the tissue removal device 100.

[0041] The tissue removal device 100 broadly includes a head assembly 102, a handle assembly 104, and a window assembly 130 (the open area within the broken line oval).

[0042] In some embodiments, the handle assembly 104 can include a battery, a power switch, and a motor. In some embodiments, the battery can be one or more disposable batteries that power the tissue removal device 100. In other embodiments, the battery can be rechargeable. For example, the handle assembly 104 includes a rechargeable battery that can power a motor enclosed within the handle assembly 104. The motor system can include or drive a reciprocating motor shaft (that moves back and forth linearly), which powers the motion of the blade in the head assembly 102. In such embodiments, the handle assembly 104 is configured to provide versatility and compatibility with interchangeable head assemblies (e.g., head assembly 102) of varying sizes, widths, and types of blades. The motor drive system is configured to facilitate a seamless conversion of rotational motion to linear- reciprocating motion, enabling the blade to move back and forth rapidly (see arrow 235 of FIG. 2B).

[0043] In some embodiments, the handle assembly 104 is configured to be separably couplable with various types of head assemblies 102. In this way, a user (e.g., a clinician such as a surgeon) can customize the tissue removal device 100 to suit a goal of the surgical procedure. For example, a surgeon can couple the handle assembly 104 to a first head assembly 102 for a de-epithelizing procedure for a subject (e.g., a mammal). In case the surgeon also needs to harvest tissue from the subject (e.g., for a skin graft), the surgeon can remove the first head assembly 102 and couple a different head assembly to the handle assembly 104. Different head assemblies are described in more detail in connection with FIGS. 5, 6, and 9.

[0044] The handle assembly 104 includes a drive system linkage that converts rotational motion of the motor to linear-reciprocating motion such that a blade is driven to move side- to-side (see arrow 235 of FIG. 2B). For example, the blade can move side-to-side such that the motion is transverse to the longitudinal axis of the handle (e.g., see the handle movement 220 of FIGS. 2A and 2B). This mechanism moves the blade in a controlled manner, providing more consistent contact with the tissue (e.g., skin). The steady and predictable reciprocating motion decreases unpredictable movement that is associated with manual procedures.

[0045] The head assembly 102 includes the blade 116. In some embodiments, the head assembly 102 includes a window assembly 130. The window assembly 130 provides structure to the blade 116 / tissue interface. The window assembly 130 is configured in a wishbone shape such that a center portion defines a void (e.g., an open area that serves as a window) such that a surgeon has an unobstructed view of the tissue to be removed. The window assembly 130 allows a surgeon to view the tissue and make real-time adjustments to facilitate accurate removal of the intended tissue. By having a direct view of the surgical site, the surgeon can assess the depth, angle, and extent of tissue removal, ensuring accuracy and minimizing the risk of incomplete, inconsistent, or excessive removal.

[0046] FIG. IB depicts an exploded view of the example tissue removal device 100 of FIG. 1A. The head assembly 102 is couplable to a window assembly 130 comprising a window cover top 108, a window cover bottom 110, and a window blade support 114. The window blade support 114 is configured to connect to a motion plate 112 using one or more fasteners 106', such as pins, screws, clips, or latches.

[0047] The motor in the handle assembly 104 is coupled to and spins a hub 105 about the central axis of the motor. The hub 105 includes a radially offset drive pin 107 affixed thereto and projecting therefrom. The radially offset drive pin 107 travels around a circle as the hub 105 spins. In some embodiments, the radius of the circle that the offset drive pin 107 travels around is within a range of about 3 mm to about 8 mm. In some embodiments, the offset drive pin 107 travels around a circle with a radius of about 5 mm. The radius of the circle that the offset drive pin 107 travels around is equal to the radial offset distance of the offset drive pin 107 from the central axis of the motor.

[0048] The radially offset drive pin 107 extends into and slidably engages within a slot 113 that is defined by the motion plate 112 located in the head assembly 102. The extended length of the slot 113 runs perpendicularly in comparison to the edge of the blade 116 of the head assembly 102. Accordingly, as the radially offset drive pin 107 is driven by the motor to travel around in a circle, the radially offset drive pin 107 will freely slide along the length of the slot 113 while driving / forcing the motion plate 112 to linearly reciprocate, back-and- forth, along the direction of the edge of the blade 116.

[0049] The motion plate 112 is coupled to a plate 111 of the window blade support 114 using the fasteners 106'. The window blade support 114 and motion plate 112 are slidably sandwiched between the window cover top 108 and the window cover bottom 110 and aligned together with the fasteners 106.

[0050] The configuration described above converts the pure rotational movement of the motor in the handle assembly 104 into the reciprocating motion of the blade 116. In the embodiments shown in FIG. 1A and IB, the window blade support 114 has a wishbone shape with a first side 109 and a second side 109' to provide stability to the blade 116. The area between the first side 109 and the second side 109' is unobstructed (e.g., defining a void) which allows visibility to the blade 116 and tissue interface. Along with stability, the wishbone-shaped window blade support 114, enhances accuracy of the tissue removal device 100 by facilitating improved control. For example, the window blade support 114 provides stability to the head assembly 102, limiting unintended vibrations, allowing for smooth and accurate cutting actions while minimizing the risk of damage or discomfort to the patient. The visibility provided by the wishbone shape and the stability of the window blade support 114 improves accuracy as the surgeon can make small modifications (e.g., modifications to the pressure and / or angle) and the tissue removal device 100 will cut predictably.

[0051] The blade 116 can be made from any suitable material. Non-limiting examples of materials include carbon steel, stainless steel, high carbon stainless steel, ceramic coated stainless steel, and polytetrafluoroethylene (PTFE) coated blades. In some embodiments, the blade 116 is a PTFE coated blade. The blade 116 is secured to the window blade support 114 with fasteners 106" and blade backer 118. The blade backer 118 secures the blade 116 to a flat position while avoiding interference with the cutting motion of the blade 116.

[0052] FIG. 1C shows an alternative head assembly 102'. The head assembly 102' includes a shaft 140 that extends laterally across the opening defined by the window assembly 130. In addition, the shaft 140 extends through a roller 142 such that the roller 142 is within the opening defined by the window assembly 130. This roller 142 can be applied to the skin during the tissue removal procedure. The roller 142 will be rolled across the skin surface as the clinician operator pulls the device 100 across the tissue of a subject toward the clinician operator to perform surgical tissue de-epithelialization or skin harvesting. The roller 142 will stretch the skin of the subject and thereby enhance the efficacy of the tissue removal procedure. The roller 142 will also facilitate removal of the de-epithelialized skin up and away from the cutting blade 116.

[0053] FIGS. 2A and 2B depict perspective views of an example tissue removal device 200 with an example stabilization device (e.g., a surface guard 226). FIG. 2A depicts a side perspective view the tissue removal device 200 with a surface guard 226. The tissue removal device 200 includes a handle assembly 204 and a head assembly 202 that include features as described in connection with a handle assembly 104 and a head assembly 102 of FIGS. 1A- 1B. FIG. 2A depicts an example of a blade angle 222 and handle angle 224 relative to the tissue 228 (e.g., the skin of a subject). The blade angle 222 is the angle of the blade as it removes tissue 228. In some embodiments, the blade angle 222 is about 5° to about 25°, about 10° to about 25°, about 15° to about 25°, or about 20° to about 25°. In some embodiments, the blade angle 222 is about 15°. The handle angle 224 is the angle of the handle assembly 204 relative to the tissue 228. In some embodiments, the handle angle 224 is about 15° to about 45°, about 20° to about 45°, about 25° to about 45°, about 30° to about 45°, about 35° to about 45°, or about 40° to about 45°. In some embodiments, the handle angle 224 is about 30°.

[0054] The blade angle 222 and handle angle 224 improve ergonomics of the surgeon when the tissue removal device 200 is pulled toward the surgeon when used (see handle movement 220). The example tissue removal device 200 also includes a surface guard 226. The surface guard 226 is an example of a tissue stabilization device that can be paired with a tissue removal device (e.g., any tissue removal device described herein). The surface guard 226 can be made from a transparent plastic to improve visibility when the tissue removal device 200 is in use.

[0055] Tissue stabilization devices such as the surface guard 226 can provide support when removing tissue 228 (e.g., epidermis) from soft tissues. Soft tissue presents a challenge for de-epithelization and tissue harvesting procedures because soft tissue can be unsupported. Unsupported tissue is more flexible and mobile which can present a challenge to isolating the epidermis and maneuver a tissue removal device. These challenges can lead to inconsistency in the thickness of the tissue removed. A tissue stabilization device such as the surface guard 226 can improve soft tissue removal from a subject by providing even pressure distribution which can keep the tissue 228 taunt and distribute force across the tissue 228 as the tissue removal device 200 is pulled toward the surgeon (i.e., see handle movement 220).

[0056] Tissue stabilization devices can be of any shape. For example, a square, a rectangle, a circle, a triangle, a non-symmetrical shape, or a nonuniform shape. In some embodiments, the surface guard 226 is a rectangle in shape and precedes the blade 216. In some embodiments, the surface guard 226 follows the blade 216. In some embodiments, the surface guard 226 surrounds the blade such that it follows and precedes the blade 216. In some embodiments, the surface guard 226 has spring suspension features to allow for continuous contact with the tissue 228 as a surface angle of the tissue 228 changes. For example, the surface angle of the tissue 228 can change based, in part, on how firm or soft the tissue 228 is and / or the anatomical location of the tissue 228 (e.g., an elbow).

[0057] The surface guard 226 can be attached and detached from the tissue removal device 200. In some embodiments, the surface guard 226 is selectively coupled to the tissue removal device 200 based on the procedure of tissue removal being performed.

[0058] FIG. 2B depicts a top-down view of the example tissue removal device 200 of FIG. 2A. The example tissue removal device 200 in FIG. 2B is positioned on tissue 228 (e.g., skin of a subject) which is visible through the window assembly 230 and the surface guard 226. The head assembly 202 includes the blade 216 that is fixed in position at the blade angle 222 of FIG. 2A. The blade 216, when actuated, moves in a linear motion 235 (e.g., side-to-side) that is transverse to a longitudinal axis 233 of the handle assembly 204. For example, when the tissue removal device 200 is powered, the blade 216 moves from side to side (see arrow 235) and tissue 228 can be removed and / or collected via the tissue exit 234 (indicated by the broken line). The handle assembly 204 includes a power switch 232 and a charging port 231. The charging port 231 can be used to charge the battery within the handle assembly 204. A user can power the tissue removal device 200 using the power switch 232. In some embodiments, the handle assembly 204 can include other switches to increase or decrease the speed of the blade 216. In some embodiments, the power switch 232 can include functionality to increase or decrease the speed of the blade 216.

[0059] In an example operation, a user positions the tissue removal device 200 on an area of the tissue 228. The user actuates the power switch 232 to power a motor in the handle assembly 204 and actuate the blade 216 to move in a back-and-forth motion as indicated by the arrow 235. The blade 216 is fixed at a predetermined blade angle (e.g., blade angle 222 of FIG. 2A) such that tissue can be removed at a more uniform thickness. To begin removal, the user pulls the tissue removal device 200 toward the user’s body as indicated by the handle movement 220. As the tissue 228 is removed, it passes through the tissue exit 234 and can be collected. The user can view the tissue 228 through the window assembly 230 and the surface guard 226. The surface guard 226 distributes even pressure on the tissue 228 which can keep soft tissue taunt and distribute force across the tissue 228 as the tissue removal device 200 is pulled toward the user (i.e., see handle movement 220).

[0060] FIG. 3 depicts a perspective view of an example tissue removal device 301 with a counter roller interface plate 340. The counter roller interface plate 340 is another example of a stabilization device. The example tissue removal device 301 includes a handle assembly 304, a window assembly 330, and a head assembly 302 that includes features as described in connection with a handle assembly 104, 204, window assembly 130, 230, and head assembly 102, 202 of FIGS. 1 A-1B and 2A-2B respectively. The tissue removal device 301 can include a power switch 332 that operates as described in connection with power switch 232 of FIG. 2B.

[0061] The counter roller interface plate 340 is an example of a stabilization device which can be used for de-epithelization or tissue harvesting. The counter roller interface plate 340 can be made from a transparent plastic to improve visibility when the tissue removal device 301 is in use. The counter roller interface plate 340 can provide support when removing epidermis from soft tissues. The counter roller interface plate 340 can facilitate the removal of a continuous piece of tissue for skin grafting procedures. In some embodiments, the counter roller interface plate 340 can include rollers or bearings that allow it to roll or glide smoothly along the skin surface. For example, the rollers or bearings roll counter to the to the cutting direction. In some embodiments, the rollers or bearings are configured to rotate clockwise. In some embodiments, the rollers or bearings are configured to rotate counterclockwise to provide tension on the tissue. The rollers or bearings can minimize friction between the tissue removal device 301 and the tissue. In some embodiments, the bearings or rollers are driven by a motor.

[0062] The counter roller interface plate 340 is configured to work in tandem with the blade (e.g., blade 116 and 216 of FIGS. 1A-1B and 2A-2B) of the tissue removal device 301. For example, the tissue removal device 301 is pulled toward a user’s body as indicated by handle movement 320, the counter roller interface plate 340 rolls along the tissue, applying even pressure and contact between the blade and the tissue to be removed. The tissue that is removed can pass through the tissue exit 334 to be collected (e.g., for use as a skin graft). In the context of skin grafting, the counter roller interface plate 340 enables uniform cutting of the donor skin, resulting in a high-quality graft that can minimize pain and improve healing. FIG. 4 is a bottom-up view of an example tissue removal device 400 with a blade guard 442. The tissue removal device 400 can include features as described in connection with FIGS. 1 A-1B, 2A-2B, and 3. The tissue removal device 400 includes a blade 416 and a blade guard 442. The blade guard 442 can be used in conjunction with the tissue removal device 400 as a protective component positioned underneath the blade 416. It serves as a safety measure to prevent accidental contact between the blade 416 and the patient's skin or underlying tissues during de-epithelization or a tissue harvesting procedure.

[0063] The blade guard 442 can be made from a durable material, such as plastic or metal, which is designed to withstand the forces exerted during the cutting process. The blade guard 442 can be shaped to match the contour of the blade 416 and can be securely attached to the tissue removal device 400. The blade guard 442 is configured to create a physical barrier between the blade 416 and the patient's tissue and / or the tissue of a user or assistant. It effectively shields the surrounding tissue from the blade 416, reducing the risk of unintentional cuts or injury.

[0064] Additionally, the blade guard 442 can incorporate features such as springs to deploy or retract the blade guard 442. In some embodiments, the tissue removal device 400 can have a mechanical switch that when actuated by a user, will deploy or retract the blade guard 442. For example, the blade guard 442 can cover the blade 416 until the procedure begins. Then, a user can retract the blade guard 442 to expose the blade 416. In some embodiments, the blade guard 442 includes notches or guides to help guide the tissue removal device 400 smoothly along the tissue. In some embodiments, the notches or guides on the blade guard 442 can include measurement markings or indicators to assist surgeons in accurately setting the depth and thickness of the tissue removal. These features facilitate improved consistency and control in cutting, improved safety, precision, and uniformity during tissue removal procedures.

[0065] FIG. 5 is another example of a tissue removal device 503 with an open blade attachment 544. The example tissue removal device 503 includes a handle assembly 504 and a head assembly 502 that includes features as described in connection with a handle assembly 104, 204, 304, and a head assembly 102, 202, 302 of FIGS. 1A-1B, 2A-2B, and 3. The tissue removal device 503 can include a power switch 532 that operates as described in connection with power switch 232, 332 of FIG. 2B and 3. The open blade attachment 544 can include a blade 516 as described in connection with blade 116, 216, 316 of FIGS. 1A-1B, 2A-2B, and 3.

[0066] The open blade attachment 544 is an example of an interchangeable head assembly that can couple to the handle assembly 504. Interchangeable head assemblies allow a surgeon to select a suitable size for the specific tissue removal need during a surgical procedure. For example, the open blade attachment 544 can be used as a vibratory scalpel to remove excess tissue or precision margins after a de-epithelization or tissue harvesting procedure.

[0067] FIG. 6 is another example of a tissue removal device 605 with a scalpel blade attachment 646. The example tissue removal device 605 includes a handle assembly 604 and a head assembly 602 that include features as described in connection with a handle assembly 104, 204, 304, 504 and a head assembly 102, 202, 302, 502 of FIGS. 1A-1B, 2A-2B, 3, and 5. The tissue removal device 605 can include a power switch 632 that operates as described in connection with power switch 232, 332, 532 as described in connection with FIG. 2B, 3 and 5. The scalpel blade attachment 646 can include a blade 617 as described in connection with blade 116, 216, 316, 516 of FIGS. 1A-1B, 2A-2B, 3, and 6.

[0068] The scalpel blade attachment 646 is an example of an interchangeable head assembly that can couple to the handle assembly 604. Interchangeable head assemblies allow a surgeon to select the most suitable size or shape of blade for the specific tissue removal need during a surgical procedure. For example, the scalpel blade attachment 646 can be used as a vibratory scalpel to remove excess tissue or execute precision cuts before or after a de-epithelization or tissue harvesting procedure.

[0069] FIG. 7 is an example of a stabilization device 750 for use with a tissue removal device (e g., the tissue removal devices 100, 200, 301, 503, 605 described in connection with FIGS. 1 A-1B, 2A-2B, 3, 5, and 6). The stabilization device 750 includes a gasket tissue interface 754, a stabilization window 756, a handle 752, and a suction port 758. The gasket tissue interface 754 can be a flexible component used to create a vacuum seal between the stabilization device 750 and the tissue of a subject. The gasket tissue interface 754 is configured to generate suction or negative pressure, facilitating it to adhere to tissue and create a secure and airtight seal. When the gasket tissue interface 754 forms a seal with the tissue, the tissue within the stabilization window 756 is taunt. The stabilization window 756 is an area that is framed by the gasket tissue interface 754 and where a tissue removal device can be operated to remove tissue.

[0070] The suction port 758 can be coupled to a suction source during operation. For example, the suction port 758 can be coupled to a centralized suction system in an operating room. A user can grasp the handle 752 with a first hand and a tissue removal device with a second hand to remove tissue. A stabilization device (e.g., the stabilization device 750) can decrease the need for additional personal as it can be used in tandem with a tissue removal device.

[0071] FIG. 8 is an example of system 860 including a tissue removal device 800 paired with the stabilization device 850 (i.e., tissue stabilization device 750 of FIG. 7). The system 860 includes a tissue removal device 800 that includes features as described in connection with the tissue removal devices 100, 200, 301, 503, and 605 of FIGS. 1A-1B, 2A-2B, 3, 5, and 6. The system 860 depicts the tissue removal device 800 in position on tissue 828 and in operation with the stabilization device 850. The gasket tissue interface (e.g., the gasket tissue interface 754 of FIG. 7) is interfaced with the tissue 828 and the tissue removal device 800 is positioned in the stabilization window (e.g., the stabilization window 756 of FIG. 7).

[0072] In an example operation, a user can apply a suction to the suction port 858. When the position of the tissue 828 to be removed has been selected, the user can grasp the handle 852 with a first hand and the handle assembly 804 with a second hand. Viewing the tissue 828 through the window assembly 830 and the stabilization window of the stabilization device 850, the user can power on the tissue removal device 800 and move the tissue removal device 800 with the stabilization device 850 at approximately the same time. The user directs the movement of the tissue removal device 800 and the stabilization device 850 toward the body of the user (see handle movement 820).

[0073] FIG. 9 is an example kit 980 that includes a handle assembly 904, interchangeable head assemblies 944 and 917, a stabilization device 950, a surface guard 926, a counter roller interface plate 940, and a window assembly 930. The example kit 980 can include a handle assembly 904 that includes the features described in connection with handle assembly 104, 204, 304, 504, 604, and 804 of FIGS. 1A-1B, 2A-2B, 3, 5, 6, and 8. The handle assembly 904 is compatible various interchangeable head assemblies 944 and 917 (e.g., head assemblies 102, 202, 302, 502, and 602 of FIGS. 1A-1B, 2A-2B, 3, 5, and 6). The handle assembly 904 is also compatible with a window assembly 930 that includes the features described in connection with window assemblies 130, 230, 330, 530, 630, and 830 of FIGS. 1A-1B, 2A-2B, 3, 5, 6, and 8. The a stabilization device 950, the surface guard 926, and the counter roller interface plate 940 can include the features as described in connection with the stabilization device 750 of FIG. 7 and 850 of FIG. 8, the surface guard 226 of FIGS. 2A-2B, and the counter roller interface plate 340 of FIG. 3. In some example embodiments, a kit 980 can include the components (e.g., various interchangeable head assemblies 944 and 917, the stabilization device 950, the surface guard 926, the counter roller interface plate 940, and the window assembly 930) absent the handle assembly 904.

[0074] In some embodiments, the kit 980 includes a handle assembly 904 that is configured to be separably couplable to disposable attachments. For example, one or more of the interchangeable head assemblies 944 and 917, the stabilization device 950, the surface guard 926, the counter roller interface plate 940, and the window assembly 930 can be configured to be a disposable component (e.g., used for a limited quantity of procedures). Disposable components can provide benefits to the user and to the patient.

[0075] For example, a kit 980 can be cost-effective by having a reusable motorized handle assembly 904. The initial investment is made when the handle assembly 904 is obtained, reducing the need for frequent repurchases of the handle assembly 904. Using disposable components (e.g., head assemblies 944 and 917, the stabilization device 950, the surface guard 926, the counter roller interface plate 940, and / or the window assembly 930) with the reusable motorized handle assembly 904 decreases the need for sharpening, replacing, the components, reducing maintenance costs over time.

[0076] Disposable components (e.g., interchangeable head assemblies 944 and 917, the stabilization device 950, the surface guard 926, the counter roller interface plate 940, and / or the window assembly 930) provide an improved levels of safety compared to reusable components. The risk of cross-contamination and infection transmission is significantly reduced as a patient receives a new, sterile components for their procedure. This helps maintain strict infection control protocols and minimizes the potential for complications.

[0077] Disposable components (e.g., interchangeable head assemblies 944 and 917, the stabilization device 950, the surface guard 926, the counter roller interface plate 940, and / or the window assembly 930) offer reliable sharpness, providing improved performance during tissue de-epithelization and / or tissue harvesting procedures.

[0078] With disposable components (e.g., interchangeable head assemblies 944 and 917, the stabilization device 950, the surface guard 926, the counter roller interface plate 940, and / or the window assembly 930), there is no need for time-consuming and potentially error-prone processes like cleaning, sterilizing, or sharpening the blades after a use. This saves valuable time during procedures and streamlines the workflow for healthcare professionals.

[0079] Disposable components (e.g., interchangeable head assemblies 944 and 917, the stabilization device 950, the surface guard 926, the counter roller interface plate 940, and / or the window assembly 930) decrease the risk of residual contaminants or inadequate sterilization that may be associated with reusable components. By using a new set of disposable components for a patient, the risk of cross-contamination and the transmission of infectious agents is reduced as compared to reusing such components. This can help ensure a high quality of hygiene and infection control.

[0080] Utilizing disposable components (e.g., interchangeable head assemblies 944 and 917, the stabilization device 950, the surface guard 926, the counter roller interface plate 940, and / or the window assembly 930) can enhance patient confidence and satisfaction, as the patient can be assured of receiving fresh, sterile components specifically for their procedure. This commitment to patient safety and hygiene can help build trust and contribute to a positive patient experience.

[0081] Single use components (e.g., interchangeable head assemblies 944 and 917, the stabilization device 950, the surface guard 926, the counter roller interface plate 940, and / or the window assembly 930) can be manufactured using many different manufacturing techniques. In some examples, disposable components can be generated with additive manufacturing. The benefits of additive manufacturing include the customization of the design and modeling. A user can create a digital design of the component according to specifications specific to their intended use. This can be done using computer-aided design (CAD) software. The design includes the specifications, such as dimensions, shapes, and features of the components. The material selected for disposable components contributes to their functionality, safety, and compatibility with de-epithelialization and / or tissue harvesting procedures. In some embodiments, materials used in additive manufacturing for medical applications include biocompatible polymers such as polyamide (nylon) or medical-grade resins.

[0082] FIG. 10 is a flowchart of an example method 1000 of tissue removal according to aspects of the disclosure. The method 1000 is an example method for removing tissue from a subject with a tissue removal device (e.g., any of the tissue removal devices described in connection with FIGS. 1A-1B, 2A-2B, 3, 4, 5, 6, 7, 8, or 9). The method 1000 includes (at step 1002) selecting an area of tissue of the subject. For example, a user (e.g., a surgeon) selects an area of the subject (e.g., a patient) for tissue removal. In some cases, the area chosen is based on the procedure (e.g., de-epithelization or tissue harvesting).

[0083] The method 1000 can further include (at step 1004) configuring a tissue removal device to remove tissue from the selected area of the subject at a predetermined depth. For example, the user predetermines a depth of tissue to be removed and sets the blade angle of the tissue removal device to remove tissue at the predetermined depth.

[0084] The method 1000 can further include (at step 1006) positioning the tissue removal device on the tissue in the selected area. For example, the user positions the tissue removal device on the area of tissue to be removed. In some cases, the user visually confirms placement by viewing the tissue through a window assembly on the tissue removal device.

[0085] The method 1000 can further include (at step 1008) pulling the tissue removal device in a direction that is toward a user. For example, the user can power on the tissue removal device and pull the device across the selected tissue of the subject. In some cases, the tissue, once removed from the tissue removal device, is collected.

[0086] Testing of Embodiments

[0087] Tests were performed using the tissue removal devices described herein. The testing sessions were very successful overall, with the prototype devices performing very well on both pig skin and human cadaver specimens.

[0088] The testing included using increased power capabilities, which resulted in significant functional improvements — allowing the surgeon-users to cut with a one hand pulling motion toward the surgeon while providing slight countertraction.

[0089] The time needed to perform breast tissue de-epithelialization using the prototype devices allowed the surgeon-users to remove the human cadaver tissue breast 80% faster than using the scalpel method (45 seconds vs. 3 minutes 43 seconds). The consistency of the cut was more uniform with the new prototype devices as compared to using the scalpel only.

[0090] Other Embodiments It is to be understood that while the methods, kits and devices have been described in conjunction with the detailed description thereof, the foregoing description is intended to illustrate and not limit the scope of the methods, kits and devices, which are defined by the scope of the appended claims. Other aspects, advantages, and modifications may be within the scope of the following claims.

Claims

WHAT IS CLAIMED IS:

1. A tissue removal device, comprising: a handle assembly, comprising: a rechargeable battery; a motor that is electrically coupled to the rechargeable battery, the motor comprising a motor drive shaft extending along an axis of the motor; and a hub attached to the motor drive shaft and comprising a drive pin that is radially offset from the axis of the motor by a distance such that rotations of the motor drive shaft cause the drive pin to travel around a circle having a radius equal to the distance and with a center on the axis of the motor; and a head assembly that is releasably coupleable to the handle assembly and the drive pin, the head assembly comprising a blade, wherein the head assembly includes mechanisms configured to convert the travel of the drive pin around the circle into linear reciprocating movements of the blade.

2. The tissue removal device of claim 1, wherein the blade is configured to remove tissue at a predetermined depth respective to a dermal layer of the tissue.

3. The tissue removal device of claim 1 or 2, wherein the mechanisms of the head assembly comprises a motion plate defining a slot configured to receive the drive pin.

4. The tissue removal device of claim 3, further comprising a window assembly that is configured to be removably couplable to the head assembly and the handle assembly.

5. The tissue removal device of claim 4, wherein the window assembly is configured to couple to the motion plate and the blade.

6. The tissue removal device of claim 4, further comprising a roller disposed within an opening defined by the window assembly and extending transverse to the longitudinal axis.

7. The tissue removal device of claim 1, further comprising a stabilization device.

8. The tissue removal device of claim 7, wherein the stabilization device is a surface guard removably coupled to the head assembly.

9. The tissue removal device of claim 8, wherein the surface guard is transparent and coupled to the head assembly such that the surface guard distributes force to the tissue being removed.

10. The tissue removal device of claim 7, wherein the stabilization device is a counter roller interface plate removably coupled to the head assembly.

11. The tissue removal device of claim 10, wherein the counter roller interface plate comprises rollers configured to rotate counter to a cutting direction.

12. The tissue removal device of claim 7, wherein the stabilization device includes a stabilization window where the tissue removal device is positioned.

13. The tissue removal device of claim 12, wherein the stabilization device is not coupled to the tissue removal device.

14. The tissue removal device of claim 13, wherein the stabilization device comprises a gasket tissue interface that is configured to apply suction to the tissue.

15. The tissue removal device of claim 1, wherein the window blade support includes a first side and a second side with a void therebetween.

16. The tissue removal device of claim 15, wherein the void provides a view of the tissue that is to be removed by the blade.

17. The tissue removal device of any one of claims 7 through 16, wherein a sharp portion of the blade is positioned in a same direction as a motion of the handle assembly.

18. The tissue removal device of any one of claims 7 through 16, further comprising a blade guard coupled to the head assembly.

19. The tissue removal device of any one of claims 7 through 16, wherein the blade positioned at a predetermined angle to remove the tissue at the predetermined depth.

20. A method of removing tissue from a subject, the method comprising: selecting an area of tissue of the subject; configuring a tissue removal device to remove tissue from the selected area of the subject at a predetermined depth; positioning the tissue removal device on the selected area; and pulling, by a user of the tissue removal device, the tissue removal device in a direction that is toward the user.

21. The method of claim 20, wherein the tissue removal is performed during a de- epithelization procedure.

22. The method of claim 20, wherein the tissue removal is performed during a tissue harvesting procedure.

23. The method of claim 20, wherein the tissue removed is an epidermal layer of the tissue.

24. The method of any one of claims 20 through 23, the method further comprising: detaching a first head assembly from a handle assembly of the tissue removal device; and attaching a second head assembly to the handle assembly of the tissue removal device.

25. The method of claim 24, further comprising removing additional tissue using the second head assembly.

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