Skin biopsy device

Abstract

An example skin biopsy device is provided. The skin biopsy device includes a plate including a top surface and an opposing bottom surface. The plate includes an opening formed therein. The skin biopsy device includes a cutting arm movably mounted relative to the plate. The cutting arm includes a blade. The opening formed in the plate is configured and dimensioned to at least partially receive therethrough a lesion. The cutting arm is configured to move along the top surface of the plate such that the blade moves over the opening of the plate to cut the lesion to obtain a biopsy sample.

Description

SKIN BIOPSY DEVICECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of a co-pending, commonly assigned U.S. Provisional Patent Application No. 63 / 611,401, which was filed on December 18, 2023. The entire content of the foregoing provisional application is incorporated herein by reference.BACKGROUND

[0002] Shave skin biopsies are one of the most widely used procedures performed by dermatologists to obtain a tissue sample for histologic examination, especially for potentially cancerous growths. A traditional shave skin biopsy procedure involves an injection of local anesthetic to the area to numb and raise the site where the procedure is to be performed. Once numb and sufficiently raised, a sufficient sample of the lesion is typically shaved off with a surgical blade (e.g., a razor blade, or the like).

[0003] Such shave skin biopsies are traditionally performed by trained dermatologists with a surgical blade with a molded plastic grip (e.g., a DERMABLADE® by AccuThrive, or the like). Even with the grips, such specialized surgical blades can be difficult to handle during the procedure, which generally requires a side-to-side motion for shaving of the tissue. Dermatologists rely on their experience and training to ensure the biopsy is performed correctly. Primary care physicians are typically not trained in the performance of shave skin biopsies and refer patients to dermatologists for the procedure. Shallow biopsies can result in an inconclusive diagnosis, while deep biopsies can result in adverse scarring. Even with training and experience, inadequate biopsies can occur. Standardizing the process of shave biopsy can improve the quality of the specimen for analysis.SUMMARY

[0004] Embodiments of the present disclosure provide an exemplary shave skin biopsy device that provides a convenient structure for obtaining a tissue biopsy with minimal training. The exemplary device allows primary care physicians, physician extenders or technicians, and some dermatologists, to perform the biopsy procedure without extensive training. In particular, the device refines or enhances the shave biopsy process, reducing the skill and training required, while improving the quality and reliability of samples, e.g., consistently providing areliable sample. The skin biopsy device includes a frame that allows the physician or technician to conveniently position the device at the site in which the biopsy is to be taken, and includes a cutting arm with a blade that provides a smooth cutting motion across the site to obtain the biopsy sample. The cutting arm can pivot freely, and since the blade is attached to the cutting arm at an angle, the blade creates a slicing motion across the biopsy site. The device is convenient to grip and provides a stable platform for obtaining reliable and consistent biopsy samples.

[0005] In accordance with embodiments of the present disclosure, an exemplary skin biopsy device is provided. The skin biopsy device includes a plate including a top surface and an opposing bottom surface. The plate includes an opening formed therein. The skin biopsy device includes a cutting arm movably mounted relative to the plate. The cutting arm includes a blade. The opening formed in the plate is configured and dimensioned to at least partially receive therethrough a lesion. As used herein, the term “lesion” refers to skin or an element thereof that requires biopsy and histopathologic evaluation. The term “lesion” may be used interchangeably with the term “mole” herein, and is intended to include both benign and / or malignant growths. In particular, although the device is discussed as being used for obtaining a biopsy sample from a mole, it should be understood that the device can be used for obtaining a biopsy sample from any lesion. The cutting arm is configured to move along the top surface of the plate such that the blade moves over the opening of the plate to cut the lesion to obtain a biopsy sample.

[0006] In some embodiments, the plate can define a substantially flat structure along the top surface and the bottom surface. In some embodiments, the skin biopsy device can include a frame including first, second and third sections joined at respective corners. The frame can define a substantially triangular’ configuration with an empty interior between the first, second and third sections. In some embodiments, the first and third sections of the frame can include grooves formed therein along inward facing surfaces. The grooves are configured to slidably receive edges of the plate for coupling of the plate to the frame.

[0007] One comer of the frame can include a hole for passage of a fastener therethrough. The cutting arm can include a linkage with a corresponding hole for coupling the cutting arm to the frame. The holes of the frame and linkage therefore form a pivot axis for the cuttingarm. The cutting arm includes a body with the blade. The cutting arm includes a linkage extending at an angle from the body. In some embodiments, the angle can be between about 25-60°, inclusive. The angle of the linkage results in movement of the blade across the opening of the plate in a non-linear (e.g., rotary), slicing manner.

[0008] The cutting arm can include a body with side blocks and a ramped section inbetween the side blocks. The ramped section is configured to receive the biopsy sample during and after cutting of the lesion with the blade. In some embodiments, a rear edge of the ramped section can include a cutout for pushing of the cutting arm with a finger of a practitioner. In some embodiments, the cutting arm can include a handle extending from one of the side blocks. The handle provides a grip for pushing or sliding the cutting arm across the plate.

[0009] In accordance with embodiments of the present disclosure, an exemplary skin biopsy device is provided. The skin biopsy device includes a frame, and a plate coupled to the frame. The plate includes a top surface, an opposing bottom surface, and an opening formed in the plate. The skin biopsy device includes a cutting arm pivotally mounted to the frame. The cutting arm includes a blade. The opening formed in the plate is configured and dimensioned to at least partially receive therethrough a lesion. The cutting arm is configured to pivot relative to the frame and move along the top surface of the plate such that the blade moves over the opening of the plate to cut the lesion to obtain a biopsy sample.

[0010] The frame can include first, second and third sections joined at respective corners, the first and third sections can include grooves formed therein along inward faces to slidably receive edges of the plate for coupling the plate to the frame. The cutting arm can include a body with the blade. The cutting arm can include a linkage extending at an angle from the body. In some embodiments, the angle can be between about 25-60°, inclusive. The cutting arm can include a body with side blocks and a ramped section in-between the side blocks. The ramped section can be configured to receive the biopsy sample during and after cutting of the lesion with the blade.

[0011] In accordance with embodiments of the present disclosure, an exemplary method of obtaining a biopsy sample is provided. The method includes positioning a lesion through an opening in a plate of a skin biopsy device. The plate includes a top surface and an opposing bottom surface. The method includes moving a cutting arm of the skin biopsy device alongthe top surface of the plate such that a blade of the cutting arm moves over the opening of the plate to cut the lesion to obtain the biopsy sample.

[0012] In accordance with embodiments of the present disclosure, an exemplary skin biopsy device is provided. The device includes a plate including a top surface and an opposing bottom surface. The plate includes an opening formed therein. The device includes a cutting arm movably mounted relative to the plate, the cutting arm including a blade. The opening formed in the plate is configured and dimensioned to at least partially receive therethrough a lesion. The cutting arm is configured to move along the top surface of the plate such that the blade moves over the opening of the plate to cut the lesion.

[0013] In some embodiments, the plate can define a substantially flat structure along the top surface and the bottom surface. In some embodiments, the device can include a frame including a top surface and a recessed area formed in the top surface. The top surface of the plate can be within the recessed area and extends along a plane vertically offset relative to the top surface of the frame. In some embodiments, a wall of the recessed area can intersect and truncates a portion of the opening formed in the plate.

[0014] In some embodiments, the device can include a safety latching mechanism extending from the frame into the recessed area and includes an extension complementary to a groove formed in the cutting arm. Engagement of the extension with the groove of the cutting arm retains the cutting arm in a first position to avoid movement of the cutting arm and cutting of the lesion.

[0015] The cutting arm can include a body with the blade, and further includes a linkage extending at an angle from the body. In some embodiments, the angle can be between about 25-60°, inclusive. The angle of the linkage results in movement of the blade across the opening of the plate in a non-linear, slicing manner. In particular, the angle of the linkage results in movement of the blade across the opening in a non-perpendicular and non-parallel direction relative to a rotational direction of the cutting aim.

[0016] The cutting aim can include a body with a ramped section disposed above the blade and configured to receive the biopsy sample during and after cutting of the lesion with the blade. The device can include a channel formed in the top surface of the frame. The channelincludes an extension protruding within the channel, and the cutting arm includes a post extending from a bottom surface of the cutting arm and configured to at least partially engage with the channel of the frame. During cutting of the lesion, the cutting arm moves from a first position into a second position and the post of the cutting arm engages with the extension to prevent reversed movement of the cutting arm to the first position, thereby maintaining the cutting arm in the second position.

[0017] In accordance with embodiments of the present disclosure, an exemplary skin biopsy device is provided. The device includes a frame including a top surface and an opposing bottom surface. The device includes a recessed area formed in the frame and defining a plate. An opening is formed in the plate. The device includes a cutting arm pivotally mounted to the frame. The cutting arm includes a blade. The opening formed in the plate is configured and dimensioned to at least partially receive therethrough a lesion. The cutting arm is configured to pivot relative to the frame and move along the top surface of the plate such that the blade moves over the opening of the plate to cut the lesion.

[0018] In some embodiments, a top surface of the plate can be within the recessed area and extends along a plane vertically offset relative to the top surface of the frame. In some embodiments, a safety latching mechanism can extend from the frame into the recessed area and includes an extension complementary to a groove formed in the cutting arm. Engagement of the extension with the groove of the cutting arm retains the cutting arm in a first position to avoid cutting of the lesion. The cutting arm can include a body with a blade, and the cutting arm can include a linkage extending at an angle from the body. The angle of the linkage results in movement of the blade across the opening in a non-perpendicular and non-parallel direction relative to a rotational direction of the cutting arm.

[0019] In accordance with embodiments of the present disclosure, an exemplary method of obtaining a biopsy sample is provided. The method includes positioning a lesion through an opening in a plate of a skin biopsy device. The plate includes a top surface and an opposing bottom surface. The method includes moving a cutting arm of the skin biopsy device along the top surface of the plate such that a blade of the cutting arm moves over the opening of the plate to cut the lesion.

[0020] Any combination and / or permutation of embodiments is envisioned. Other objects and features will become apparent from the following detailed description considered in conjunction with the accompanying drawings. It is to be understood, however, that the drawings arc designed as an illustration only and not as a definition of the limits of the present disclosure.BRIEF DESCRIPTION OF THE DRAWINGS

[0021] To assist those of skill in the art in making and using the skin biopsy device, reference is made to the accompanying figures, wherein:

[0022] FIG. 1 is a top perspective view of an exemplary skin biopsy device in accordance with embodiments of the present disclosure.

[0023] FIG. 2 a top perspective view of an exemplary skin biopsy device of FIG. 1 with a cutting arm in a first position.

[0024] FIG. 3 is a top perspective view of an exemplary skin biopsy device of FIG. 1 with a cutting arm in a second position.

[0025] FIG. 4 is a bottom perspective view of an exemplary skin biopsy device of FIG. 1.

[0026] FIG. 5 is a top view of an exemplary skin biopsy device of FIG. 1 with a cutting arm in a first position.

[0027] FIG. 6 is a top view of an exemplary skin biopsy device of FIG. 1 with a cutting arm in a second position.

[0028] FIG. 7 is a side view of an exemplary skin biopsy device of FIG. 1.

[0029] FIG. 8 is a cross-sectional side view of an exemplary skin biopsy device of FIG. 1.

[0030] FIG. 9 is an exploded view of an exemplary skin biopsy device of FIG. 1.

[0031] FIG. 10 is a top perspective view of a frame of an exemplary biopsy device ofFIG. 1.

[0032] FIG. 11 is a top perspective view of a frame of an exemplary biopsy device of FIG. 1.

[0033] FIG. 12 is a top view of a frame of an exemplary biopsy device of FIG. 1.

[0034] FIG. 13 is a bottom view of a frame of an exemplary biopsy device of FIG. 1.

[0035] FIG. 14 is a side view of a frame of an exemplary biopsy device of FIG. 1.

[0036] FIG. 15 is a perspective view of a plate of an exemplary biopsy device of FIG. 1.

[0037] FIG. 16 is a top view of a plate of an exemplary biopsy device of FIG. 1.

[0038] FIG. 17 is a top perspective view of a cutting arm of an exemplary biopsy device of FIG. 1.

[0039] FIG. 18 is a top perspective view of a cutting arm of an exemplary biopsy device of FIG. 1.

[0040] FIG. 19 is a top perspective view of a cutting arm of an exemplary biopsy device of FIG. 1.

[0041] FIG. 20 is a bottom perspective view of a cutting arm of an exemplary biopsy device of FIG. 1.

[0042] FIG. 21 is a side view of a cutting arm of an exemplary biopsy device of FIG. 1.

[0043] FIG. 22 is a top view of a cutting arm of an exemplary biopsy device of FIG. 1.

[0044] FIG. 23 is a bottom view of a cutting arm of an exemplary biopsy device of FIG. 1.

[0045] FIG. 24 is a top perspective view of an exemplary skin biopsy device in accordance with embodiments of the present disclosure, including a cutting arm in a first position.

[0046] FIG. 25 is a top perspective view of an exemplary skin biopsy device of FIG. 24 including a cutting arm in a first position.

[0047] FIG. 26 is a top view of an exemplary skin biopsy device of FIG. 24 including a cutting arm in a first position.

[0048] FIG. 27 is a bottom view of an exemplary skin biopsy device of FIG. 24 including a cutting arm in a first position.

[0049] FIG. 28 is a top perspective view of an exemplary skin biopsy device of FIG. 24 including a cutting arm in a second position.

[0050] FIG. 29 is a top perspective view of an exemplary skin biopsy device of FIG. 24 including a cutting arm in a second position.

[0051] FIG. 30 is a top view of an exemplary skin biopsy device of FIG. 24 including a cutting arm in a second position.

[0052] FIG. 31 is a bottom view of an exemplary skin biopsy device of FIG. 24 including a cutting arm in a second position.

[0053] FIG. 32 is an exploded view of an exemplary skin biopsy device of FIG. 24.

[0054] FIG. 33 is a top perspective view of a frame of an exemplary skin biopsy device of FIG. 24.

[0055] FIG. 34 is a side view of a frame of an exemplary skin biopsy device of FIG. 24.

[0056] FIG. 35 is a top view of a frame of an exemplary skin biopsy device of FIG. 24.

[0057] FIG. 36 is a bottom perspective view of a frame of an exemplary skin biopsy device of FIG. 24.

[0058] FIG. 37 is a bottom view of a frame of an exemplary skin biopsy device of FIG. 24.

[0059] FIG. 38 is a top perspective view of a cutting arm of an exemplary skin biopsy device of FIG. 24.

[0060] FIG. 39 is a bottom perspective view of a cutting arm of an exemplary skin biopsy device of FIG. 24.

[0061] FIG. 40 is a top perspective view of a cutting arm of an exemplary skin biopsy device of FIG. 24.

[0062] FIG. 41 is a front view of a cutting arm of an exemplary skin biopsy device of FIG. 24.

[0063] FIG. 42 is a top view of a cutting arm of an exemplary skin biopsy device of FIG. 24.

[0064] FIG. 43 is a bottom view of a cutting arm of an exemplary skin biopsy device of FIG. 24.DETAILED DESCRIPTION

[0065] An exemplary skin biopsy device is provided that allows a practitioner to accurately and consistently take a biopsy sample with minimal training. The device includes a frame with a plate for positioning over the biopsy site. The device includes a surgical blade attached or co-molded to a cutting arm which pivots or moves freely and is attached to the plate and / or frame. The plate includes a hole for receiving the skin to be sampled. For example, the mole can first be raised above the skin into a “bleb” by injecting the mole with lidocaine, and the device is placed on the patient’ s body with the raised bleb at least partially extending up through the hole in the plate.

[0066] In some embodiments, the skin around the mole can be stretched by the other hand of the practitioner before placement of the device over the mole. Once positioned on the patient, the plate of the device can maintain the surrounding skin taut. The practitioner then rotates the cutting ami, pushing the blade through or under the mole. The blade is attached to the cutting arm in an offset manner from the radius of the cutting arm. This creates a slicing motion (e.g., curving or angled motion) over the hole in the plate (and against the mole), rather than a linear motion, which mimics the manual slicing motion that dermatologists use traditionally. The slicing motion assists with smoothly cutting the mole or tissue without necessitating a back-and-forth cutting or slicing motion. The ease of use of the device reduces the training required for the practitioner (e.g., hours rather than months or years), while providing reliable and consistent samples.

[0067] As noted previously, traditional technology for shave skin biopsies generally involves a blade with a plastic molded grip. However, such blade does not assist or guide the practitioner in obtaining a successful sample in a reliable and consistent manner. The exemplary skin biopsy device assists the practitioner to ensure the cut is taken at the intended depth, while eliminating the possibility of slipping. The depth of the cut can be set by the pressure that is put on the skin with the device and the pivot point of the cutting arm only allows for motion in one single path. The cutting motion and, thereby, the entire biopsy procedure, is significantly simplified. The hole in the plate, the use of a pivoting cutting arm (or sliding cutting arm), and the offset angle of the arm to improve slicing individually and in combination assist with improving the biopsy process. The device constrains the motion ofthe blade and simplifies the slicing motion across the biopsy site. The device also allows the practitioner to line up a cut before performing a procedure, rather than performing the biopsy with no motion constraints and while judging how deep to cut. As such, greater stability, ease of control, and accuracy is given to the practitioner when using the device, hi some embodiments, the direction of motion of the blade can be varied depending on whether the practitioner is right-handed or left-handed.

[0068] The simplicity of use of the device reduces the amount of training required to perform the biopsy. Rather than relying exclusively on specialized dermatologists to perform the biopsy, non-physicians (such as nurses and physician assistants) can perform the shave biopsy. Fabrication of the device is minimal and can provide significant savings gained from employing less trained practitioners for performing the procedure. In some embodiments, the device could be disposable. In some embodiments, the device (or at least portions of the device) could be sterilized and reusable. The device can be used at pediatrician, urgent care, and general practitioner offices instead of referring patients to dermatologists, which would allow such offices to bring the procedure in-house for the convenience of the patient. As such, the device provides several advantages over traditional biopsy procedures.

[0069] FIGS. 1-9 are perspective, top, side, cross-sectional and exploded views of an exemplary skin biopsy device 100 (hereinafter “device 100”). The device 100 includes a frame 102, a platform or plate 104 detachably secured to the frame 102, and a cutting aim 106 movable relative to the frame 102 and plate 104 in a slicing motion. In some embodiments, the cutting arm 106 can pivot relative to the frame 102 and plate 104 to create the slicing motion. In some embodiments, the cutting arm 106 can move at an angle relative to the frame 102 and plate 104 without pivoting to create the slicing motion. The device 100 includes a surgical blade 108 that can be secured to the bottom of the cutting arm 106 or can be co-molded into the cutting arm 106. One or more components of the device 100 can be replaceable to allow for sterilization of the remaining components of the device 100 and reuse. In some embodiments, a fastening assembly (e.g., a bolt 110, a washer 112, and a nut 114) can be used to secure the cutting arm 106 to the frame 102.

[0070] As discussed in greater detail below, the plate 104 includes an opening 116 that is configured and dimensioned to at least partially receive the patient tissue or skin therethroughfor obtaining a biopsy sample. In particular, the skin of the patient can be stretched before placement of the device 100 onto the skin, with the plate 104 acting as a means to maintain the skin at least partially taut underneath the device 100. The mole or other tissue to be sampled extends at least partially through the opening 116 in the plate 104. In the first or furthermost starting position of the cutting arm 106 (see, e.g., FIGS. 2 and 5), the cutting arm 106 and the blade 118 are positioned entirely on one side of the opening 116. In some embodiments, in the first position, the blade 118 can be spaced from the opening 116 by a predetermined minimum distance (e.g., about 1-2 mm, or the like) to avoid accidental / premature cutting of the biopsy site. In some embodiments, a safety mechanism (e.g., a latching or locking mechanism) can secure the cutting arm 106 in the first position, and can be disengaged when the practitioner is ready to use the device 100.

[0071] In some embodiments, minimal friction between the cutting arm 106 and the plate 104 can maintain the cutting arm 106 in the first position until the practitioner is ready to use the device 100. When the practitioner is ready to obtain the biopsy sample, the cutting arm 106 can be moved or pivoted across the opening 116 in the direction 118 (see, e.g., FIGS. 3 and 6). As discussed herein, the structure of the cutting arm 106 ensures that the blade 108 passes across the opening 116 in a slicing motion (e.g., in a diagonal or curved motion) rather than a linear / perpendicular path to assist with cutting of the tissue with the blade 108. Such slicing motion generated by the cutting arm 106 mimics the type of motion used by practitioners in traditional biopsy methods. However, rather than a potentially variable motion (e.g., due to the practitioner having full control of the blade motion in traditional procedures), the cutting arm 106 and frame 102 ensure that the biopsy procedure and slicing motion is consistent and reliable each time, resulting in a higher instance of proper biopsy samples.

[0072] FIGS. 10-14 are perspective, top, bottom and side views of the frame 102. The frame 102 can be fabricated from a plastic or metal material. The frame 102 includes a body that defines a substantially triangular shape with a first linear section 120, a second linear section 122, and a third linear section 124 connected to each other at respective comers 126, 128, 130. In some embodiments, the length of each section 120, 122, 124 can be about, e.g., 1.5-4 inches inclusive, 1.5-3.5 inches inclusive, 1.5-3 inches inclusive, 1.5-2.5 inches inclusive, 1.5-2 inches inclusive, 2-4 inches inclusive, 2.5-4 inches inclusive, 3-4 inchesinclusive, 3.5-4 inches inclusive, 2-3.5 inches inclusive, 2.5-3 inches inclusive, 1.5 inches, 2 inches, 2.5 inches, 3 inches, 3.5 inches, 4 inches, or the like. In some embodiments, the sections 120, 124 can be about 3.5 inches and the section 122 can be about 3.5 inches. The first and third sections 120, 124 include an inner groove 132, 134 formed therein and extending the length of the sections 120, 124. The height of the grooves 132, 134 is dimensioned to receive a respective edge of the plate 104 in a sliding manner, with minimal up-and-down movement of the plate 104 within the grooves 132, 134.

[0073] The overall height or thickness of the sections 120, 124 is dimensioned greater than the height or thickness of the section 122. In particular, as illustrated in FIG. 11, the bottom surface of the sections 120, 122, 124 can be aligned along the same plane. In contrast, as illustrated in FIG. 10, the top surface of the sections 120, 124 is offset along a different plane compared to the top surface 136 of the section 122. The top surface 136 of the section 122 can be substantially aligned with the bottom surface of the grooves 132, 134, such that the plate 104 can be guided into the grooves 132, 134 along the top surface 136. Due to the substantially trapezoidal configuration of the plate 104, sliding of the plate 104 along the grooves 132, 134 towards the corner 130 fixates the plate 104 within the frame 102 as the distance between the sections 120, 124 narrows.

[0074] In some embodiments, the plate 104 can be co-molded with the frame 102. In some embodiments, the plate 104 can be fabricated as a single structure with the frame 102. The plate 104 is coupled to the frame 102 as close to the bottom surface of the frame 102 as possible to ensure that the plate 104 is positioned against the skin of the patient without interference from the edges of the frame 102 (e.g., without the frame 102 elevating the plate 104 over the skin surface).

[0075] The distal end of the sections 120, 124 (e.g., near the corner 130) includes upward ramps 138, 140 along the top surface that lead to a flat mounting platform 142 for coupling of the cutting aim 106 to the frame 102. The platform 142 is elevated or offset from the top surfaces of the sections 120, 124, and extends along a plane parallel to the top surfaces of the sections 120, 124. The bottom surface of the mounting platform 142 includes a step 144, 146 at the distal ends of the sections 120, 124, which results in the platform 142 having a thinner structure than the sections 120, 124. The mounting platform 142 includes a hole 148 forpassage of the bolt 110 therethrough. For a device 100 including a cutting arm 106 that pivots to create the slicing motion, the central axis of the hole 148 acts as the rotary or pivot axis for the cutting arm 106.

[0076] With reference to FIGS. 15-16, perspective and top views of the plate 104 arc provided. The plate 106 includes a flat or planar body 150 that defines a substantially trapezoidal configuration. The body 150 includes edges 152, 154, 156 joined at pointed comers (with edge 154 connecting edges 152, 156 at the proximal end), and a distal or top edge 158 that connects edges 152, 156 at pointed corners. The tapered edges 152, 156 allow for the plate 106 to be slid into the grooves 132, 134 of the frame 102 with the edge 158 leading into the frame 102. The plate 106 slides along the grooves 132, 134 until the edge 158 substantially aligns or is positioned under the platform 142 to provide a sliding surface between sections 120, 122, 124 of the frame 102.

[0077] The plate 104 can be fabricated from a plastic or metal material with a thickness as thin as possible while maintaining rigidity for support against the skin of the patient. In some embodiments, the plate 104 can be fabricated from a metal and is co-molded into the plastic frame 102. The thin structure of the plate 104 allows the mole, tissue, or skin of the patient to pass through the opening 116 sufficiently high above the plate 104 surface to obtain the biopsy sample. Rigidity of the plate 104 material maintains the plate 104 firmly on the skin of the patient and creates a uniform surface along which cutting can be performed with the cutting arm 104. Rigidity of the plate 104 also allows the practitioner to put pressure on the plate 104 during the procedure. In some embodiments, the thickness of the plate 106 can be about, e.g., 0.005-0.1 inches inclusive, 0.005-0.05 inches inclusive, 0.005-0.01 inches inclusive, 0.01-0.1 inches inclusive, 0.05-0.1 inches inclusive, 0.005 inches, 0.01 inches, 0.05 inches, 0.1 inches, or the like.

[0078] With reference to FIGS. 17-23, perspective, side, top and bottom views of the cutting arm 106 are provided. The cutting arm 106 includes a body 160 with a top surface 162, an opposing bottom surface 164, a front surface 166, and an opposing rear surface 168. The body 160 can define a substantially rectangular configuration. In some embodiments, the body 160 can be fabricated from a metal or plastic. The body 160 includes two side blocks 170, 172 on opposing sides of the body 160 that define the full height as measured between the top andbottom surfaces 162, 164. The side blocks 170, 172 are separated by a ramped section 174 that is lowest at the front surface 166 and gradually tapers upward towards the rear surface 168. The ramped section 174 defines the smallest thickness or height at the front surface 166 (e.g., at or near the bottom surface 164), and defines the largest thickness or height at the rear surface 168 (e.g., at or near the top surface 162). The ramped section 174 can serve as a catch area for the biopsy sample, such that during and after cutting, the biopsy sample travels at least partially along the ramped section 174 and remains in the ramped section 174 for removal by the practitioner.

[0079] In some embodiments, the top edge of the ramped section 174 (e.g., the connecting edge of the top and real' surfaces 162, 168) can include a rounded cutout 176 configured to partially receive the thumb of the practitioner to assist with moving the cutting arm 106 across the plate 104. The cutout 176 can provide a surface upon which the practitioner can push to pivot or move the cutting arm 106. In some embodiments, the practitioner can push against the rear surface 168. In some embodiments, the cutting arm 106 can include handle 178 extending from the side block 170. In some embodiments, the handle 178 can define a substantially cylindrical configuration and can extend at a rearward angle relative to the top surface 162. The handle 178 can be gripped or pinched by the practitioner to assist with pushing or moving the cutting arm 106 across the plate 104.

[0080] The bottom surface 164 of the cutting arm 106 includes a recessed area 180 configured to receive the blade 108 (see, e.g., FIGS. 1-9). The recessed area 180 is formed in the middle of the body 160 and extends up to the front surface 162 such that surrounding side areas 182, 184 of the bottom surface 164 remain at a larger thickness (as measured from the top surface 162) than the recessed area 180. In particular, as illustrated in FIG. 21, the recessed area 180 extends at a plane offset and above the plane defined by the bottom surface 164. The depth of the recessed area 180 is selected such that when the blade 108 is coupled with the cutting arm 106, the bottom surface of the blade 108 remains elevated above the plane defined by the bottom surface 164 of the cutting arm 106. In some embodiments, the offset distance of the bottom of the blade 108 from the bottom surface 164 of the cutting arm 106 can be about, e.g., 0.005-0.1 inches inclusive, 0.005-0.05 inches inclusive, 0.005-0.01 inches inclusive, 0.01- 0.1 inches inclusive, 0.05-0.1 inches inclusive, 0.005 inches, 0.01 inches, 0.05 inches, 0.1inches, or the like. Such offset positioning of the blade 108 ensures that when the bottom surface 164 moves along the plate 104, the blade 108 does not shave or cut the top of the plate 104. In some embodiments, the blade 108 can be positioned directly against the plate 104 and moves along the top surface of the plate 104 (e.g., without a gap between the blade 108 and the plate 104).

[0081] In some embodiments, the recessed area 180 can include one or more grooves 186 configured to receive epoxy for securing the blade 108 to the cutting arm 106. In some embodiments, the bottom surface 164 can include a relief cutout 188 extending from the recessed area 180 towards the rear surface 168. The relief cutout 188 can be sized and positioned such that when the cutting arm 106 passes over the opening 116 of the plate 104 and cuts the biopsy site, the continued passage of the cutting arm 106 over the biopsy site avoids contact between the bottom surface 164 of the cutting arm 106 and the biopsy site. In particular, the relief cutout 188 passes over the biopsy site and creates an offset between the cutting arm 106 and the biopsy site. Such separation avoids contact with the recently formed wound at the biopsy site.

[0082] The cutting arm 106 includes a linkage 190 extending from the body 160 (e.g., from the side block 172). The bottom surface of the linkage 190 can be substantially aligned with the bottom surface 164, while the top surface of the linkage 190 is offset from the top surface 162 of the body 160. The thinner profile of the linkage 190 allows for clearance during assembly with the frame 102. The linkage 190 extends from the body 160 at an angle 192 of about, e.g., 25-60° inclusive, 25-55° inclusive, 25-50° inclusive, 25-45° inclusive, 25-40° inclusive, 25-35° inclusive, 25-30° inclusive, 30-60° inclusive, 35-60° inclusive, 40-60° inclusive, 45-60° inclusive, 50-60° inclusive, 55-60° inclusive, 30-55° inclusive, 35-50° inclusive, 35-40° inclusive, 25°, 30°, 35°, 40°, 45°, 50°, 55°, 60°, or the like (see, e.g., FIGS. 22-23).

[0083] The angle 192 between the linkage 190 and body 160 creates an offset of the blade 108 such that when the cutting arm 106 rotates relative to the opening 116 of the plate 104, the edge of the blade 108 moves at an angle in a slicing motion across the opening 116 (see, e.g., FIGS. 5-6). In particular, the edge of the blade 108 moves across and downward across the opening 116, and therefore does not travel in a linear direction across the opening 116. Suchmotion improves the slicing or cutting action of the blade 108 along the biopsy site (e.g., a smoother cut), and substantially mimics the slicing or cutting motion used in traditional biopsy procedures. The blade 108 is therefore angled as it passes over the opening 116. The distal or furthermost area of the linkage 190 includes a hole 194 for coupling of the cutting arm 106 to the frame 102.

[0084] During assembly, the blade 108 and the cutting arm 106 are coupled together (or co-molded). The plate 104 is inserted into the grooves 132, 134 of the frame 102 such that the edge 154 of the plate 104 aligns with or sits on top of the section 122 of the frame 102. The hole 194 of the linkage 190 of the cutting arm 106 is then aligned with the hole 148 of the frame 102, and the bolt 110, washer 112, and nut 114 assembly is used to couple the cutting arm 106 to the frame 102. In some embodiments, the fastener assembly can be covered by a separate housing (not shown). During use, the cutting arm 106 pivots and moves across the top surface of the plate 104, with the blade 108 create a slicing motion across the opening 116 in the plate 104. In some embodiments, rather than a pivot arm, the device 100 can include tracks or an alternative structure that allows the cutting arm 106 to slide in a non-radial manner across the opening 116 of the plate 104. The device 100 therefore provides a convenient structure for obtaining a biopsy sample with consistent and reliable results.

[0085] FIGS. 24-32 are perspective, top, bottom and exploded views of an exemplary skin biopsy device 200 (hereinafter “device 200”). The device 200 can be substantially similar in structure and / or function to the device 100, except for the distinctions noted herein. The device 200 provides a semi-automatic operation for taking a skin biopsy of a patient. The device 200 is configured to keep the skin of the patient taut enough to perform a cut of the lesion, guiding the blade movement and ensuring a complete biopsy is performed. The cutting arm of the device 200 pivots or rotates relative to the frame during the cutting operation, selectively guiding the angle and swinging arm motion for the blade to perform a sliding motion. In order to ensure that the blade completes the lesion cut, the frame includes a wall either intersecting an edge of the opening receiving the lesion or positioned immediately adjacent to the edge of the opening. During the cutting motion, the blade crushes or pushes the sample against the wall, completing the cut. The cutting arm can move the blade translationally while maintaining the blade at an angle, e.g., controlling the movement of the blade at an angle relative to thedirection of motion, ensuring the slicing motion is achieved. The direction of motion can be rotating or sliding.

[0086] The device 200 can be used to cut a small circular (or non-circular) sample from the skin of a patient. It should be understood that the device 200 can be used for human patients, as well as non-human patients. The device 200 can be a single use device, or can be used multiple times prior to disposal. In some embodiments, a medical professional can first raise a portion of the skin (e.g., a bleb) by injecting the site with lidocaine. In some embodiments, the device 200 can be used without a raised bleb, local geometry permitting. Although discussed herein as being used to obtain shave biopsies, it should be understood that the device 200 can be used to take larger samples, make deeper excisions, or perform other types of operations.

[0087] During use, the device 200 can be placed on the skin such that the opening is substantially centered on the lesion. The device 200 can be held against the skin by applying downward force around the edge of the frame. In some embodiments, the frame can include indentations, markings or grooves on the top and / or sides of the frame to guide finger placement for the holding hand of the user. The device 200 can be operated with one hand, with two, or with two operators. The bottom of the frame pressed downward on the skin, and the bleb pokes through the opening and above the top of the base plate of the frame. Pushing down on the plate holds the skin taut and brings the bleb above the base plate for cutting. The skin should generally be held taut to ensure a clean cut of the lesion.

[0088] In some embodiments, the opening in the frame can be a circle, or a regular or irregular polygon, or other arbitrary shape. In some embodiments, the opening can be a circle with a segment cut off by an intersecting wall configured to assist with and ensure a clean and full cut is performed. In some embodiments, the opening can be a custom size and / or shape for a particular' patient or procedure. In some embodiments, the opening can be adjustable in size and / or shape. In some embodiments, the opening can be of a dynamic shape (e.g., changing during the procedure) to ensure the skin is maintained taut. For example, in some embodiments, the opening can define a blended aperture / iris configuration, with segments of the outer circle capable of being selectively moved inward or outward to change the opening shape and / or size.

[0089] Once the device 200 has been properly positioned, the cutting arm can be moved (e.g., slid, rotated, or both) by the user across the bleb to cut the sample. The cutting arm can be pushed or pulled with an open finger / thumb, or pinched and moved. The cutting arm can include a notch groove / cut on the top of the cutting arm for pushing / pulling, and a pair of indentations at the far / distal end of the cutting arm for pinching, pushing, and / or pulling. The configuration of the device 200 allows for it to be used by right-handed and left-handing users.

[0090] The cutting arm pivots about a pivot point. Because the cutting arm rotates and the blade is at an angle to a ray or line from the point of rotation, the effective motion of the blade on the sample is an approach at an angle. The angled approach is a mechanical reproduction of the sawing motion used by medical professionals when hand-cutting, and therefore recreates an efficient slicing motion for cutting of the sample. The sample, once separated, rests on a cutout area, e.g., a catchment area, of the cutting arm, ready to be analyzed. On the underside of the cutting arm, a relief area, e.g., a cutout area or groove) can be left to ensure that the cutting arm does not touch the open wound after the incision by the blade has been made.

[0091] The blade can be, e.g., a straight, double-bevel, metal razor blade, or the like. In some embodiments, the blade can be, e.g., ceramic, plastic, glass, or the like. In some embodiments, the blade can be, e.g., single-bevel, curved, or the like. The blade can be attached to the bottom of the cutting arm with, e.g., chemical adhesive, mechanical force, combinations thereof, or the like, hr some embodiments, the cutting arm and the frame can be fabricated from, e.g., plastic, metal, other materials, combinations thereof, or the like.

[0092] In some embodiments, the cutting arm and frame can snap together for the pivoting engagement. In some embodiments, alternative fasteners can be used to rotatably secure the cutting arm to the frame. In some embodiments, the frame and the base plate (e.g., opening plate) can be formed as a single structure / piece. In some embodiments, the frame and the base plate can be formed as separate structures / pieces. The device 200 can include a flexible lever to retain the cutting arm in the pre-cut position (i.e., the first position) for shipping and procedure setup (e.g., before beginning the cut).

[0093] The device 200 can include a flexible lever which latches onto a notch in the cutting arm at the end of the cutting motion to maintain the cutting arm in the “final” position, allowing the medical professional to remove the biopsy sample without movement of the cutting arm.In some embodiments, after most of the cut has been completed, the blade intersects with the wall of the frame to complete the cutting motion, e.g., chopping or cutting the last fraction of the sample against the wall, hi some embodiments, the device 200 can complete the cutting motion with the wall engagement at the end of the cutting cycle.

[0094] With reference to FIGS. 24-32, the device 200 generally includes a frame 202 including a platform or plate 204 with an opening 206 configured to at least partially receive a lesion therethrough. The device 200 includes a cutting arm 208 hingedly or pivotally coupled to the frame 202 such that the blade 210 associated with the cutting arm 208 can be translated or slid over the opening 206 to cut the lesion for obtaining the skin biopsy. As discussed in greater detail below, the device 200 can include a safety engagement feature in the form of a groove 212 formed in the cutting arm 208 and a complementary flexible extension 214 (e.g., a flexible lever) formed in the frame 202.

[0095] As illustrated in FIGS. 24-25, the extension 214 engages with the groove 212 to maintain the cutting arm 208 in a first position, e.g., in preparation for cutting but safely stowed until the device 200 is ready to be used. In particular, the extension 214 and groove 212 engagement avoids undesired movement of the cutting arm 208 along the plate 204 until the device 200 is ready to be used. When the device 200 is ready to be used and is in the desired position relative to the patient, sliding of the cutting arm 208 in a cutting direction 216 (see FIG. 26) flexes the extension 214 outward and away from the groove 212 to permit unobstructed rotation and sliding of the cutting arm 208 along the plate 204. The engagement feature therefore provides a safety mechanism for the device 200. The cutting arm 208 is therefore able to perform a complete rotation from the first position into a second position (see FIGS. 28-30) in which the full rotational range of the cutting arm 208 has been reached and the edge of the blade 210 is at the furthest point of the opening 206, thereby ensuring a complete cut of the lesion.

[0096] FIGS. 33-37 are perspective, side, top and bottom views of the frame 202 for the device 200. The frame 202 generally defines a substantially circular or curved side perimeter edge 218, although it should be understood that any configuration for the perimeter edge 218 could be used. The frame 202 includes a top surface 220 configured to be positioned away from the skin of the patient, and an opposing bottom surface 222 configured to be positionedagainst the skin of the patient. The surfaces 220, 222 can extend along planes substantially parallel to each other. In some embodiments, the top edge of the perimeter edge 218 can be chamfered or rounded to assist with gripping of the frame 202 during use, e.g., to provide a more ergonomic feel to the user.

[0097] The base plate 204 defines the bottom surface of a recessed area 224 formed in the top surface 220 of the frame 202. In some embodiments, the recessed area 224 can be downwardly formed in the top surface 220 by about, e.g., half of the thickness of the frame 202 as measured between the top and bottom surfaces 220, 222, or the like. The recessed area 224 generally defines the area along which the cutting arm 208 and blade 210 can travel. In particular, the recessed area 224 includes multiple side walls 226, 228, 230, 232, 234, at least some of which define the limits for travel of the cutting arm 208 and blade 210 between the first and second positions during the cutting process. For example, the cutting arm 208 can be in the first position when the cutting arm 208 is positioned against the wall 226, and can be in the second position when the blade 210 is positioned against the wall 232. The walls 226-234 can extend substantially perpendicularly from the plate 204.

[0098] In some embodiments, the wall 232 can intersect the opening 206 formed in the plate 204, thereby truncating a section of the opening 206. In some embodiments, the wall 232 can be positioned adjacent to the opening 206 with the opening 206 forming a complete circle. In operation, the edge of the blade 210 can abut the wall 232 to complete the final cutting motion and ensuring that the biopsy sample is fully cut from the lesion. In some embodiments, an upper portion of the wall 232 can include a section 236 angled or chamfered outwardly away from the recessed area 224. In some embodiments, the angled section 236 can assist with guiding the biopsy sample onto the top surface 220 of the frame 202 for removal by the medical professional. In some embodiments, the angled section 236 can assist with guiding the biopsy sample onto the ramped section 302 of the cutting arm 208 (see below) after the procedure has been completed. In some embodiments, the angled section 236 can provide easier access or space for the medical professional to access the biopsy sample on the ramped section 302 of the cutting arm 208 after the procedure has been completed.

[0099] The wall 228 can define a substantially semi-circular configuration, indicative of the rotation performed by the cutting arm 208 during the slicing motion. Adjacent to the wall228, the frame 202 includes an aperture 238 formed therein. The aperture 238 extends from the top surface 220 to the bottom surface 222 and, as discussed below, is configured and dimensioned to movably receive therein a complementary structure of the cutting arm 208. hi particular, once engaged with the aperture 238, the cutting arm 208 can rotate about a pivot point formed by the longitudinal axis of the aperture 238. In some embodiments, the inner surface of the aperture 238 can be threaded or can include grooves configured to prevent disengagement of the cutting arm 208 after initial engagement with the aperture 238.

[0100] Adjacent to the wall 234 and / or forming part of the wall 234, the frame 202 can include a safety latching mechanism (e.g., a flexible lever) extending from the wall 226. The safety latching mechanism can include a narrow post or flange 240 extending from the wall 226, and an extension 214 protruding perpendicularly from the endpoint of the flange 240 towards the recessed area 224. In some embodiments, the flange 240 can be substantially linear and the extension 214 can define a semi-circular or triangular configuration with an endpoint 242. The frame 202 includes cutouts 244, 246 formed around the flange 240 and extension 214 defining a substantially complementary and spaced opening around the safety latching mechanism.

[0101] The cutouts 244, 246 extend entirely through the body of the frame 202 such that the latching mechanism is permitted to flex within the cutouts 244, 246. In particular, the thin configuration of the flange 240 allows the flange 240 to be flexed or bent away from the recessed area 224 to engage and disengage form a complementary groove 212 formed in the cutting arm 208 (see, e.g., FIGS. 24-26). This engagement allows the cutting arm 208 to be maintained in the first position without undesired movement, until intentional disengagement of the extension 214 from the groove 212 allows the cutting arm 208 to pivot towards the second position over the opening 206.

[0102] Between the wall 228 and the aperture 238, the frame 202 can include another safety latching mechanism (e.g., a flexible lever) for maintaining the cutting arm 208 in the second position after the cutting motion has been completed and the blade is positioned against the wall 232. The safety latching mechanism can include a linear or curved channel 248 formed in the top surface 220 of the frame 202. In some embodiments, the channel 248 can extend entirely through the body of the frame 202. In some embodiments, the channel 248 canextend partially through the body of the frame 202, i.e., not through the bottom surface 222. The channel 248 can define a semi-circular configuration, substantially complementary to the semi-circular configuration of the wall 228 and generally following the rotational path of the cutting arm 208.

[0103] On the inner wall nearest the aperture 238, the channel 248 includes a hook or extension 250 protruding into the channel 248. The extension 250 includes a curved or tapered first side towards the direction of the first position of the cutting arm 208, and a perpendicularly extending side, thereby defining a pointed configuration of the extension 250. As discussed below, the cutting arm 208 includes a complementary post 296 (see, FIG. 43) extending from a bottom surface 278 of a linkage 264 of the cutting arm 208. During engagement of the cutting arm 208 with the frame 202, the post 296 of the cutting arm 208 fits at least partially into the channel 248 and moves within the channel 248 during operation of the cutting arm 208.

[0104] As the cutting arm 208 moves from the first position, the post 296 slides within the channel 248 and along the ramped / tapered side of the extension 250. As the cutting arm 208 is pushed towards the second position, the post 296 slides over the uppermost point of the extension 250 and snaps back down towards the inner wall of the channel 248. The perpendicular side of the extension 250 initially prevents the post 296 from reversing and retracting its movement towards the first position of the cutting arm 208 until additional reversing force is applied, thereby maintaining the cutting arm 208 in the second position with the blade 210 against the wall 232 until reversed movement of the cutting arm 208 is desired. In some embodiments, the post 296 of the cutting arm 208 can be disengaged from the channel 248 such that the cutting arm 208 can be positioned into the first position and the device 200 can be reused for a subsequent procedure. For example, the upon application of force on the cutting arm 208 in the reverse direction towards the first position, the post 296 can disengage and pass over the extension 250 to allow for reverse movement of the cutting arm 208 (e.g., similar to the extension 214 operation described herein). In some embodiments, the latch mechanism formed by the extension 250 and the post 296 can be excluded to allow for continuous reuse of the device 200.

[0105] FIGS. 38-43 are perspective, front, top and bottom views of the cutting arm 208 of the device 200. The cutting arm 208 includes a body with a top surface 252, an opposingbottom surface 254, a front surface 256, an opposing rear surface 258, and opposing side surfaces 260, 262. The body of the cutting arm 208 can define a substantially rectangular configuration, with one side surface 262 merging into and forming a linkage 264 extending at an angle 266 (see FIG. 42) relative to the front surface 256. hi some embodiments, the angle 266 of the linkage 264 can be about, e.g., 25-60°, or the like. This angle 266 allows for the cutting arm 208 (and blade 210) to travel in a non-perpendicular and non-parallel angle to the direction 216 of rotation as the blade 210 passes over the opening 206 in the plate 204, ensuring a slicing motion is generated for cutting the lesion.

[0106] The configuration of the surfaces 254-262 can be substantially complementary to the configuration of the walls 226-234 of the recessed area 224 in the frame 202 to ensure smooth translation and travel of the cutting arm 208 within the recessed area 224. For example, the rear surface 258 of the cutting arm 208 can define a substantially concave or inwardly curved configuration complementary to the outwardly curving or convex configuration of the wall 226. The side surface 260 can define an outwardly curving configuration complementary to the concave configuration of the wall 234. The front surface 256 can define a substantially linear or flat configuration complementary to the flat or linear configuration of the wall 232. The underside edge 280 of the cutting arm 208 can define a first section 298 with a flat or lineal’ configuration complementary to the wall 230, and a second section 300 with a concave configuration complementary to the convex or outwardly curving configuration of the wall 228 (see FIG. 39). The second section 300 can therefore travel along the 228 in a smooth manner to guide and maintain stability of the cutting arm 208 motion.

[0107] The distal end 268 of the linkage 264 includes radially formed openings or slots 270, 272, 274, 276 extending through the linkage 264 body and out of the bottom surface 278 of the linkage 264. The overall thickness or height of the linkage 264 is dimensioned less than the thickness or height of the body of the cutting arm 208, resulting in the bottom surface 278 being vertically offset from the bottom surface 254. The dimensional difference also forms an underside edge 280 connecting the side surface 262 with the rear surface 258 under the linkage 264 (see FIG. 39). However, it should be understood that alternative dimensional relationships of the linkage 264 and the body of the cutting arm 208 can be used while still achieving the described operation of the device 200.

[0108] The innermost edges of each of the slots 270-276 extend downward through the linkage 264 and out of the bottom surface 278, i.e., beyond the bottom surface 278, to form respective latch arms 282, 284, 286, 288 (e.g., snap arms). Each latch arm 282-288 includes an elongated flange 290 extending from the innermost edge of the slots 270-276, and an outwardly protruding ledge 292. The ledge 292 can protrude perpendicularly from the endpoint of the flange 290, thereby defining a substantially L-shaped configuration. The elongated configuration of the flange 290 allows each of the latch arms 282-288 to flex inward toward each other upon application of a force thereon. Thus, the latch arms 282-288 can be aligned with and pushed into the aperture 238 of the frame 202. During this action, the latch arms 282-288 flex inward to pass through the aperture 238 and spring outward after passage through the aperture 238 to engage around the edge of the aperture 238 at the bottom surface 222 of the frame 202. This maintains the cutting arm 208 engaged and coupled with the frame 202, while permitting rotation of the cutting arm 208 about the longitudinal axis of the aperture 238. It should be understood that alternative engagement mechanisms known in the industry can be used between the cutting arm 208 and the frame 202 to allow for pivoting of the cutting arm 208 relative to the frame 202.

[0109] In the bottom surface 278, the linkage 264 includes an opening 294 formed between the latch aims 282-288 and the underside edge 280. Out of the opening 294 extends a post 296, e.g., a rectangular post, or the like. The distance of the post 296 extending beyond the bottom surface 278 is dimensioned less than the distance of the latch arms 282-288 extending beyond the bottom surface 278. As discussed above, during engagement of the cutting arm 208 with the frame 202, the post 296 enters at least partially into the channel 248 formed in the top surface 220 of the frame 202. As the cutting arm 208 rotates about its pivot point, the post 296 travels within the channel 248.

[0110] In particular, as the cutting arm 208 is rotated from the first position to the second position to complete the slicing motion of the blade 210, the post 296 snaps over the extension 250 of the channel 248 and prevents the cutting arm 208 from reversing its direction of travel (until the post 296 is disengaged from the extension 250). In particular, the flat or linear edge of the post 296 abuts the flat or linear edge of the extension 250 to prevent travel of the post 296 within the channel 248. The protruding extension 250 therefore functions to at leasttemporarily engage with the post 296 to prevent reverse movement of the cutting aim 208 towards the first position. The blade 210 can simultaneously abut the wall 232 of the recessed area 224 in the frame 202, temporarily locking the cutting arm 208 in the second position. This functions as a safety lever mechanism to maintain the cutting arm 208 in the second position after the biopsy sample has been taken. Force applied on the cutting arm 208 in the reverse direction towards the first position allows the post 296 to move around and disengage relative to the extension 250, permitting rotation of the cutting arm 208 towards the first position.

[0111] As discussed previously, the side surface 260 of the cutting arm 208 includes a groove 212 complementary to the flexible extension 214 in the latch arm of the frame 202. As the cutting arm 208 is positioned in the first position before initiating the cutting motion, the extension 214 can snap into the groove 212 to maintain the position of the cutting arm 208. The substantially complementary configuration of the groove 212 and extension 214 (e.g., triangular configuration, or any complementary configuration) allows for smooth “snapping” to engage the components and safety maintains the position of the cutting arm 208 until use of the device 200 is desired. Pushing and sliding the cutting arm 208 along direction 216 to perform the cutting motion disengages the extension 214 from the groove 212 and allows for continuously smooth rotation of the cutting arm 208.

[0112] The front surface 256 of the cutting arm 208 includes a ramped section 302 defining a rounded cutout extending from the front surface 256 to the top surface 252. The ramped section 302 is configured to receive the biopsy sample after the cutting procedure has been completed. The ramped section 302 can form a thin front edge 304 between the ramped section 302 and the blade 210. In particular, the bottom surface 254 includes a recessed area 306 configured and dimensioned complementary to the blade 210 such that the blade 210 can be secured within the recessed area 306 with, e.g., adhesive, fasteners, or the like.

[0113] The recessed area 306 ensures that when the blade 210 is engaged with the cutting arm 208, the blade 210 does not extend below the plane defined by the bottom surface 254 of the cutting arm 208. hi some embodiments, the bottom surface of the blade 210 can be aligned with the plane defined by the bottom surface 254 of the cutting arm 208. hi some embodiments, the bottom surface of the blade 210 can be vertically offset into the recessed area 306 relative to the plane defined by the bottom surface 254 of the cutting arm 208 to avoidcontact of the blade 210 edge with the plate 204 surface in the recessed area 224 of the frame 202.

[0114] The distal end of the recessed area 306 can include a curved recessed section 308 (c.g., a relief area) formed in the bottom surface 254 of the cutting arm 208. The curvature of the recessed section 308 is complementary to the curved pathway of the cutting arm 208 during rotation about its pivot point, and the location of the recessed section 308 is aligned with passage over the opening 206 in the plate 204. Thus, in embodiments where the cutting arm 208 can continue passage over the opening 206 after cutting of the lesion, the recessed section 308 avoids contact of the bottom surface 254 of the cutting arm 208 with the recently cut lesion. This can be beneficial if, for example, the frame 202 does not include a recessed area 224 and instead the cutting arm 208 travels along the top surface 220 of the frame 202 to perform the cutting motion (or, for example, if the wall 232 along the recessed area 224 allowed for a longer sweep of the cutting arm 208 across the frame 202, the blade 210 had a narrower configuration, or the like). In such instances, the blade 210 would pass fully over the sample due to the longer sweep allowed / required of the cutting arm 208.

[0115] In some embodiments, the cutting arm 208 can include various cutouts or grooves 310, 312 formed in the edges of the body to assist with ergonomically grasping and using the cutting arm 208 to perform the cutting motion. For example, at the front edge of the cutting arm 208 at the intersection of the top surface 252 and the front surface 256, the cutting arm 208 can include a groove 310. Similarly, the rear edge of the cutting arm 208 at the intersection of the top surface 252 and the rear surface 258 can include a groove 312. Fingers of the user can partially fit within these grooves 310, 312 to improve the overall grip on the cutting arm 208. The device 200 therefore provides a convenient structure for obtaining a biopsy sample with consistent and reliable results.

[0116] While exemplary embodiments have been described herein, it is expressly noted that these embodiments should not be construed as limiting, but rather that additions and modifications to what is expressly described herein also are included within the scope of the invention. Moreover, it is to be understood that the features of the various embodiments described herein are not mutually exclusive and can exist in various combinations andpermutations, even if such combinations or peimutations are not made express herein, without departing from the spirit and scope of the invention.

Claims

CLAIMS:

1. A skin biopsy device, comprising: a plate including a top surface and an opposing bottom surface, the plate including an opening formed therein; and a cutting arm movably mounted relative to the plate, the cutting arm including a blade; wherein the opening formed in the plate is configured and dimensioned to at least partially receive therethrough a lesion; and wherein the cutting arm is configured to move along the top surface of the plate such that the blade moves over the opening of the plate to cut the lesion.

2. The skin biopsy device of claim 1, wherein the plate defines a substantially flat structure along the top surface and the bottom surface.

3. The skin biopsy device of claim 1, comprising a frame including a top surface and a recessed area formed in the top surface.

4. The skin biopsy device of claim 3, wherein the top surface of the plate is within the recessed area and extends along a plane vertically offset relative to the top surface of the frame.

5. The skin biopsy device of claim 3, wherein a wall of the recessed area intersects and truncates a portion of the opening formed in the plate.

6. The skin biopsy device of claim 3, comprising a safety latching mechanism extending from the frame into the recessed area and including an extension complementary to a groove formed in the cutting arm.

7. The skin biopsy device of claim 6, wherein engagement of the extension with the groove of the cutting arm retains the cutting arm in a first position to avoid movement of the cutting arm and cutting of the lesion.

8. The skin biopsy device of claim 1, wherein the cutting aim includes a body with the blade, and the cutting arm further includes a linkage extending at an angle from thebody.

9. The skin biopsy device of claim 8, wherein the angle is between about 25-60°, inclusive.

10. The skin biopsy device of claim 8, wherein the angle of the linkage results in movement of the blade across the opening of the plate in a non-linear, slicing manner.

11. The skin biopsy device of claim 8, wherein the angle of the linkage results in movement of the blade across the opening in a non-perpendicular and non-parallel direction relative to a rotational direction of the cutting arm.

12. The skin biopsy device of claim 1, wherein the cutting arm includes a body with a ramped section disposed above the blade and configured to receive the biopsy sample during and after cutting of the lesion with the blade.

13. The skin biopsy device of claim 3, comprising a channel formed in the top surface of the frame, the channel including an extension protruding within the channel, and the cutting aim includes a post extending from a bottom surface of the cutting arm and configured to at least partially engage with the channel of the frame.

14. The skin biopsy device of claim 13, wherein during cutting of the lesion, the cutting arm moves from a first position into a second position and the post of the cutting arm engages with the extension to prevent reversed movement of the cutting arm to the first position, thereby maintaining the cutting arm in the second position.

15. A skin biopsy device, comprising: a frame including a top surface and an opposing bottom surface; a recessed area formed in the frame and defining a plate, wherein an opening is formed in the plate; and a cutting arm pivotally mounted to the frame, the cutting arm including a blade; wherein the opening formed in the plate is configured and dimensioned to at least partially receive therethrough a lesion; and wherein the cutting arm is configured to pivot relative to the frame and movealong the top surface of the plate such that the blade moves over the opening of the plate to cut the lesion.

16. The skin biopsy device of claim 15, wherein a top surface of the plate is within the recessed area and extends along a plane vertically offset relative to the top surface of the frame.

17. The skin biopsy device of claim 15, comprising a safety latching mechanism extending from the frame into the recessed area and including an extension complementary to a groove formed in the cutting arm.

18. The skin biopsy device of claim 17, wherein engagement of the extension with the groove of the cutting arm retains the cutting arm in a first position to avoid cutting of the lesion.

19. The skin biopsy device of claim 15, wherein the cutting arm includes a body with a blade, and the cutting arm further includes a linkage extending at an angle from the body, wherein the angle of the linkage results in movement of the blade across the opening in a non-perpendicular and non-parallel direction relative to a rotational direction of the cutting arm.

20. A method of obtaining a biopsy sample, comprising: positioning a lesion through an opening in a plate of a skin biopsy device, wherein the plate includes a top surface and an opposing bottom surface; and moving a cutting arm of the skin biopsy device along the top surface of the plate such that a blade of the cutting arm moves over the opening of the plate to cut the lesion.

Images