WO2018119480A1 - Devices and methods for performing skin biopsies - Google Patents

Abstract

Disclosed are systems and methods for performing shave biopsies with a device that automatically perform the biopsy. For instance, disclosed is a spring loaded shave biopsy device that protects the blade from unintended contact with the healthcare provider and captures the specimen so there is no need to handle the specimen or the cutting blade to dispose of it. The blade remains in the device after the biopsy. In some examples, the entire device or portions of the device are put into a fixative and sent to the pathology laboratory.

Description

DEVICES AND METHODS FOR PERFORMING SKIN BIOPSIES

FIELD OF THE DISCLOSURE

[0001] The present invention is directed to systems and methods for performing biopsies.

BACKGROUND OF THE DISCLOSURE

[0002] The following description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.

[0003] Significant numbers of patients present to primary care practices with skin disease and skin-related complaints. As described in one study, 36.5% of patients who presented to their primary care physician had at least one skin problem and in 58.7% of these cases, the skin problem was the chief complaint. Large numbers of general practice patients are referred to dermatologists, often for a biopsy of a lesion, either to confirm a suspected diagnosis, or to establish a diagnosis of lesions of unknown origin.

[0004] Dermatologists often recommend skin or shave biopsies if they recognize a suspicious growth or lesion on a patient's skin. To perform these biopsies, generally a dermatologist uses a free razor blade to remove the skin malady. Because the procedure is done with a free blade, it can only be performed by a dermatologist and not another clinician - which makes the procedure quite expensive, and potentially inconsistent.

[0005] The most common skin biopsy is a shave biopsy. A superficial shave biopsy is used for lesions that are predominantly epidermal or extend above the surface of the skin. A superficial shave involves removing a thin disk of tissue, typically using a bent double- edged razor blade to obtain the extended lesion as well as the underlying epidermis and upper dermis. The superficial shave is used for suspected superficial basal or squamous cell carcinomas, warts, papillomas, skin tags, as well as keratoses. The superficial shave biopsy may not be appropriate for certain suspicious pigmented lesions though many clinicians utilize a superficial shave biopsy even when suspecting suspicious pigmented lesions such as Melanoma. [0006] For deeper lesions and also for pigmented lesions, a saucerization shave biopsy is used. A saucerization biopsy also uses a curved blade, but the cut extends deeper, into the dermis or subcutaneous fat, yielding a thicker disk of tissue than a superficial shave. For both the superficial and saucerization biopsies, any remaining pigmented or irregular tissue may be obtained using a punch biopsy if necessary.

[0007] Today, there are about 6.8 million biopsies per year, of which dermatologists perform 5.1 million while 1.7 million are performed by the first tier of general practitioners.

[0008] The appearance of atypical lesions on the skin represent an opportunity for primary care doctors to directly perform some of these biopsies, potentially during the same initial office visit, to expedite the diagnostic process, reduce the potential of non-compliance with the dermatologist referral and to enhance their revenue per patient visit. However, certain technical elements of carrying out a skin biopsy may be less familiar to general practice physicians or physician extenders such as nurse practitioners and physician assistants.

[0009] Therefore, there is an unmet need for novel technologies to help automate and simplify the process would incentivize general practitioners to perform in-office biopsies and reduce referrals to later stages of the diagnostic process.

SUMMARY OF THE DISCLOSURE

[0010] Accordingly, disclosed are systems and methods for performing shave biopsies with a device that automatically performs the biopsy. For instance, disclosed is a spring loaded shave biopsy device that protects the blade from unintended contact with the healthcare provider and captures the specimen so there is no need to handle the specimen or the cutting blade to dispose of it. In some examples, the blade remains in the device after the biopsy. Additionally, after the caregiver performs the biopsy, the entire device or portions of it may be immersed into a fixative and sent to the pathology laboratory so that the biopsied tissue does not need to be handled or transferred by the health care provider out of the biopsy cube.

[0011] Accordingly, disclosed is a device for obtaining shave biopsies of skin lesions.

In some examples, the device includes three major components: a sample carriage, a sample cube and a firing tool. The sample carriage may be inserted into the sample cube, and the sample cube may be attached to the firing tool.

[0012] The top of the sample cube may be transparent, allowing a user to view and center a skin lesion into a hole on the sample carriage. In some examples, the user presses the sample cube down so the sample carriage presses down on the skin, allowing the skin lesion to bulge above a hole in the sample carriage. The holes on the sample carriage have various diameters and thicknesses. By choosing a certain hole and adjusting the pressure or suction applied onto skin, the user can control the area and depth of the skin biopsy.

[0013] In other examples, the device can include a rubber bulb that is connected to the sample cube, and the user may press the rubber bulb to create vacuum in the cube, sucking the skin lesion up above the hole. Following these steps, the user may then fire the spring-loaded razor blade in the firing device. This causes the razor blade to sweep across the hole and shave off the bulged skin lesion, which is retained in the sample cube and carriage.

[0014] Afterward, either the sample cube/carriage or the whole device may be immersed into a fixative solution and sent to pathologists for diagnosis. During the whole process, the user has no need to handle the razor blade or specimen directly.

[0015] The disclosed device, system, and method would make the biopsy (a) safer for provider and employees as there is no exposed blade and (b) reproducible and easy as the device should lead to earlier stage of diagnosis and thereby improving outcomes and reducing cost of care treating ailments, such as, for example, skin cancers.

[0016] The disclosed device, system, and method would allow safe and easy biopsy, since when the sled holding the blade is pushed across the skin lesion, the blade/sled gets held on the other side of the cube which covers the blade (safety) and traps the specimen (e.g., skin) in the cube (no need for health provider to handle specimen). The blade/sled assemblage can be held in place by, e.g., a small plastic hammer shaped projection within the landing zone of the cube, so that it is pushed up by the force of the sled and then snaps down when sled passes by the "hammer". The pathology technician in the pathology lab will remove the specimen by opening the top, side(s) or bottom of the cube and this ability will be built into the cube, making it a single use cube. SELECTED EMBODIMENTS

[0017] Although the above description and the attached claims disclose a number of embodiments of the present invention, other alternative aspects of the invention are disclosed in the following further embodiments.

Embodiment 1. A skin biopsy system, the system including: a sample cube including a bottom portion and a top portion; a sample carriage configured to connected to an area between the bottom and the top portion of the sample cube, the sample carriage including at least two different sized orifices; and a firing tool connected to the sample cube, the firing tool including a bottom portion and a top portion, wherein the firing tool further includes: a mount on a bottom portion of the firing tool that is configured to be connected to the top portion of the sample cube thereby placing the firing tool directly on the top portion of the sample carriage; a blade connected to the mount, wherein the blade is configured to project outwardly from the mount when depressed and retract inside the firing tool when compressed; a tensioner connected to the mount and the blade; a guide that the mount slides on, the guide including at least one of: a guide, a slot, and any other mechanical guide; and a firing button that is connected to the blade and the tensioner.

Embodiment 2. The skin biopsy system of embodiment 1, wherein the tensioner is a spring.

Embodiment 3. The skin biopsy system of claim 1, wherein the top portion of the sample cube is transparent.

Embodiment 4. The skin biopsy system of embodiment 1, wherein the at least two different sized orifices are circular.

Embodiment 5. The skin biopsy system of embodiment 1, wherein firing tool further includes a handle connected to the mount.

Embodiment 6. The skin biopsy system of embodiment 5, wherein the handle may be retracted to compress the tensioner inside of the firing tool, which moves the blade and the mount longitudinally along the guide and then lock into place with the tensioner compressed to build up pressure, which is depressed by activating the firing button. Embodiment 7. The skin biopsy system of embodiment 1 further including a vacuum source connected to the sample cube so that a patient's skin raises above the orifice on the sample carriage when the vacuum source is activated.

Embodiment 8. The skin biopsy system of embodiment 1, wherein the sample cube includes at least one transparent side.

Embodiment 9. The skin biopsy system of embodiment 1, wherein the blade is positioned to slide on the top portion of the sample carriage when fired.

Embodiment 10. The skin biopsy system of embodiment 1, wherein the sample cube has a slot that slidably receives the sample carriage to connect the sample carriage to the sample cube.

Embodiment 11. A method of performing a shave biopsy on a patient's skin, the method including: positioning a sample carriage on the skin, the sample carriage including at least one orifice; connecting the sample carriage to a sample cube, the sample cube including a bottom portion, a top portion, and a slot between the bottom portion and the top portion of the sample cube, wherein the sample carriage is configured to slidly fit into the slot; connecting the sample cube to a firing tool, wherein the firing tool includes: (a) a mount on a bottom portion of the firing tool that is configured to be connected to the top portion of the sample cube thereby placing the firing tool directly on the top portion of the sample carriage, (b) a blade connected to the mount, wherein the blade is configured to project outwardly from the mount when depressed and retract inside the firing tool when compressed, (c) a tensioner connected to the mount and the blade, (d) a guide that the mount slides on, the guide including at least one of: a guide, a slot, and any other mechanical guide, and (d) a firing button that is connected to the blade and the tensioner; applying force to the sample cube so that a portion of the patient's skin raises above the at least one orifice on the sample carriage; and depressing the firing button to cause the blade to cut off the portion of the patient's skin that is raised above the sample carriage.

Embodiment 12. A method of performing a shave biopsy on a patient's skin, the method including: positioning a sample carriage on the skin, the sample carriage including an orifice; connecting the sample carriage to a sample cube, the sample cube including a bottom portion, a top portion, and a slot between the bottom portion and the top portion of the sample cube, wherein the sample carriage is configured to slidly fit into the slot; connecting the sample cube to a firing tool, wherein the firing tool includes: (a) a mount on a bottom portion of the firing tool that is configured to be connected to the top portion of the sample cube thereby placing the firing tool directly on the top portion of the sample carriage, (b) a blade connected to the mount, wherein the blade is configured to project outwardly from the mount when depressed and retract inside the firing tool when compressed, (c) a tensioner connected to the mount and the blade, (d) a guide that the mount slides on, the guide including at least one of: a guide, a slot, and any other mechanical guide, and (d) a firing button that is connected to the blade and the tensioner; applying a vacuum source to the sample cube so that a portion of the patient's skin raises above the orifice on the sample carriage; and depressing the firing button to cause the blade to cut off the portion of the patient's skin that is raised above the sample carriage.

Embodiment 13. The method of embodiment 12 wherein the vacuum source is a plunger.

Embodiment 14. The method of embodiment 12 wherein the vacuum source is a ball based system.

Embodiment 15. The method of embodiment 12 wherein the portion of the patient's skin is placed in fixative solution after being cut off.

Embodiment 16. The method of embodiment 12 wherein at least one of the sample carriage, the sample cube, and the firing tool are placed into fixative solution after the portion of the patient's skin is cut off.

Embodiment 17. The method of embodiment 12 wherein the orifice is one of at least two orifices and further including manipulating or positioning the sample carriage to position the orifice in a cutting path of the blade.

Embodiment 18. The method of embodiment 17 wherein manipulating includes sliding.

Embodiment 19. The method of embodiment 17 wherein manipulating includes rotating.

Embodiment 20. A skin biopsy system, the system including: a sample cube with a base plate that contains an orifice; a firing tool connected to the sample cube, the firing tool including: a mount; a blade connected to the mount; and a firing mechanism. Embodiment 21. The skin biopsy system of embodiment 20, wherein the sample cube includes a drawer that slides below the base plate and is configured to close open firing of the firing tool.

Embodiment 22. The skin biopsy system of embodiment 21, wherein the drawer forms a water tight seal with a wall of the sample cube when closed.

Embodiment 23. The skin biopsy system of embodiment 21, wherein the drawer includes a hemostatic agent on a top side of the drawer.

Embodiment 24. The skin biopsy system of embodiment 20, wherein sample cube includes a pore.

Embodiment 25. The skin biopsy system of embodiment 20, wherein the sample cube includes a pressure activated light.

Embodiment 26. The skin biopsy system of embodiment 20, wherein the sample cube is disposable and the firing tool is reusable.

Embodiment 27. The skin biopsy system of embodiment 20, further including a safety mechanism that prevents the firing mechanism from firing.

Embodiment 28. The skin biopsy system of embodiment 27, wherein the safety mechanism includes a radiation emitter and detector.

Embodiment 29. The skin biopsy system of embodiment 28, wherein the radiation emitter and the detector are positioned to have a beam pass just over the orifice.

Embodiment 30. The skin biopsy system of embodiment 28, wherein the radiation emitter emits a laser light.

Embodiment 31. The skin biopsy system of embodiment 28, wherein the radiation emitter is positioned to emit the laser light in a direction that will reflect off of a reflective surface.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The accompanying drawings, which are incorporated in and constitute a part of this specification, exemplify the embodiments of the present invention and, together with the description, serve to explain and illustrate principles of the invention. The drawings are intended to illustrate major features of the exemplary embodiments in a diagrammatic manner. The drawings are not intended to depict every feature of actual embodiments nor relative dimensions of the depicted elements, and are not drawn to scale.

[0019] FIG. 1 depicts a perspective view of an example of a skin biopsy system that is constructed in accordance with the principles of the present disclosure;

[0020] FIG. 2 depicts an exploded view of an example of a firing mechanism for a skin biopsy system that is constructed in accordance with the principles of the present disclosure;

[0021] FIG. 3 depicts a perspective view of an example of a skin biopsy system that is constructed in accordance with the principles of the present disclosure;

[0022] FIG. 4 depicts a perspective view of an example of a skin biopsy system that is constructed in accordance with the principles of the present disclosure;

[0023] FIG. 5 depicts a perspective view of an example of a block for a skin biopsy system that is constructed in accordance with the principles of the present disclosure;

[0024] FIG. 6 depicts a side view of an example of a block for a skin biopsy system that is constructed in accordance with the principles of the present disclosure;

[0025] FIG. 7 A depicts a perspective view of an example of a cartridge for a skin biopsy system that is constructed in accordance with the principles of the present disclosure;

[0026] FIG. 7B depicts a side view of an example of a cartridge for a skin biopsy system; that is constructed in accordance with the principles of the principles of the present disclosure;

[0027] FIG. 8 depicts a flow chart of an example method for performing biopsies that is constructed in accordance with the principles of the present disclosure; and

[0028] FIG. 9 depicts a perspective view of an example of a shave biopsy system that is constructed in accordance with the principles of the present disclosure. [0029] FIG. 10 depicts a perspective view of an example of a shave biopsy system with a deformable blade that is constructed in accordance with the principles of the present disclosure.

[0030] FIG. 11 depicts a side view of an example of a shave biopsy system with a deformable blade that is constructed in accordance with the principles of the present disclosure.

[0031] FIG. 12 depicts a side view of an example of a shave biopsy system with a blade on a joint that is constructed in accordance with the principles of the present disclosure.

[0032] FIG. 13 depicts a perspective view of an example of a shave biopsy system with a rotatable blade that is constructed in accordance with the principles of the present disclosure.

[0033] FIG. 14 depicts a perspective view of an example of a shave biopsy system with an extendable blade that is constructed in accordance with the principles of the present disclosure;

[0034] FIG. 15 depicts a side view of an example of a shave biopsy system with a blade that can be pushed along a track that is constructed in accordance with the principles of the present disclosure;

[0035] FIG. 16 depicts a perspective view of an example of a shave biopsy system with a detachable base plate that is constructed in accordance with the principles of the present disclosure; and

[0036] FIG. 17 depicts a side view of an example of a shave biopsy system with an eccentric axis blade that is constructed in accordance with the principles of the present disclosure.

[0037] In the drawings, the same reference numbers and any acronyms identify elements or acts with the same or similar structure or functionality for ease of understanding and convenience. To easily identify the discussion of any particular element or act, the most significant digit or digits in a reference number refer to the Figure number in which that element is first introduced. DETAILED DESCRIPTION OF THE DISCLOSURE

[0038] Unless defined otherwise, technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Szycher's Dictionary of Medical Devices CRC Press, 1995, may provide useful guidance to many of the terms and phrases used herein. One skilled in the art will recognize many methods and materials similar or equivalent to those described herein, which could be used in the practice of the present invention. Indeed, the present invention is in no way limited to the methods and materials specifically described.

[0039] In some embodiments, properties such as dimensions, shapes, relative positions, and so forth, used to describe and claim certain embodiments of the invention are to be understood as being modified by the term "about."

[0040] Various examples of the invention will now be described. The following description provides specific details for a thorough understanding and enabling description of these examples. One skilled in the relevant art will understand, however, that the invention may be practiced without many of these details. Likewise, one skilled in the relevant art will also understand that the invention can include many other obvious features not described in detail herein. Additionally, some well-known structures or functions may not be shown or described in detail below, so as to avoid unnecessarily obscuring the relevant description.

[0041] The terminology used below is to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of certain specific examples of the invention. Indeed, certain terms may even be emphasized below; however, any terminology intended to be interpreted in any restricted manner will be overtly and specifically defined as such in this Detailed Description section.

[0042] While this specification contains many specific implementation details, these should not be construed as limitations on the scope of any inventions or of what may be claimed, but rather as descriptions of features specific to particular implementations of particular inventions. Certain features that are described in this specification in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, various features that are described in the context of a single implementation can also be implemented in multiple implementations separately or in any suitable subcombination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a subcombination or variation of a subcombination.

[0043] Similarly while operations may be depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. In certain circumstances, multitasking and parallel processing may be advantageous. Moreover, the separation of various system components in the implementations described above should not be understood as requiring such separation in all implementations, and it should be understood that the described program components and systems can generally be integrated together in a single software product or packaged into multiple software products.

Overview

[0044] Disclosed are systems and methods for performing shave biopsies with a device that automatically performs the biopsy. For instance, disclosed is a spring loaded shave biopsy device that protects the blade from unintended contact with the healthcare provider and captures the specimen so there is no need to handle the specimen or the cutting blade to dispose of it. In some examples, the device includes three major components: (1) a sample carriage, (2) a sample cube and (3) a firing tool. The sample carriage may be inserted into the sample cube, and the sample cube may be attached to the firing tool.

[0045] The sample carriage may be any suitable device with different shaped orifices that allow the user to press the sample carriage against the skin so the skin bulges over the top of the sample carriage. The sample carriage may be of a suitable thickness to allow the skin to bulge over in combination with suitable orifice sizes. In other examples, different shaped sample carriages may be utilized.

[0046] The top of the sample cube may be transparent, allowing a user to see and center a skin lesion into a hole on the sample carriage. In some examples, the user presses the sample cube down so the sample carriage presses down on the skin, allowing the skin lesion to bulge above the selected hole in the sample carriage. In other examples, the device can include a rubber bulb that is connected to the sample cube, and the user may press the rubber bulb to create vacuum in the cube, sucking the skin lesion up above the hole. [0047] The firing device may include a spring-loaded blade that is retained by a safety and firing button. The firing device may connect to the cube in a manner that so when the firing device is depressed and the blade is launched, it is configured to slide into the cube and placed on top of the sample carriage so that there is virtually (or actually) no room between the blade edge and the sample carriage. Accordingly, a user may fire the spring- loaded razor blade in the firing device. This causes the razor blade to sweep across the hole and shaves off the bulged skin lesion as a biopsy, which is retained in the sample cube and carriage.

[0048] Either the sample cube/carriage or the whole device is disposed into a fixative solution and sent to pathologists for diagnosis. The holes on the carriage have various diameters and thicknesses. By choosing a certain hole and adjusting the pressure or suction applied onto skin, the user can control the area and depth of the skin biopsy. During the whole process, the user has no need to handle the razor blade or specimen directly. In some examples, the user can adjust how close the blade is to the sample orifice, to additionally control the depth of biopsy. In some examples, the carriage could be turned upside down, or contain an adjustment mechanism that could line the carriage up with the sample cube at different depths.

[0049] In some examples, the cube/carriage can be pushed through the skin lesion with manual force, for example with a tab. Additionally, for saucerization (bent blades) the blades can be twisted with a dial attached on top of the cube.

[0050] FIG. 1 illustrates an example of a biopsy system 100 according to the present disclosure. The system includes a sample cube 110, a carriage 120, and a firing tool 140, wherein the sample cube 110 is configured to receive the sample carriage 120. The sample carriage 120 may be configured to slide back and forth or otherwise manipulated so that different orifices 170 of sample carriage 120 can be put into position over a skin malady. For instance, in some examples, the sample carriage 120 may be configured to slide in a slot on the sample cube 110, or the sample carriage 120 may press fit or lock into different positions for each different sized or shaped orifice 170.

[0051] The sample cube 110 may be configured to any suitable configuration to hold the sample carriage 120 and the firing tool 140. The sample cube 110 may include a plastic, metal block, or any other material that contains a transparent top portion or other means for the user to see through to the orifice 170 so that it may be centered over a skin malady. The sample cube 110, in some examples, may hold the sample carriage 120 at the bottom of the sample cube 110 so that the sample carriage 120 may easily contact the skin. In some examples, the sample carriage 120 may include a circular configuration and may rotate below the sample cube 110.

[0052] Additionally, the sample carriage 120 may include any suitable configuration that has correctly sized orifices 170 to allow skin to bulge through the orifice 170 so that it rises above the sample carriage 120 far enough that a razor can shave off the skin above it. The sample carriage may be made of a very thin plastic, metal, or other suitable materials to minimize the amount of force required for the user to press on or apply to the skin. As discussed, the sample carriage 120 may be configured to (a) slide in a slot of the sample cube 110, (b) rotate around a pivot, and/or (c) snap or press fit into other locked configurations and could be any variety of shapes.

[0053] The sample cube 110 may also be configured to connect to the firing tool 140.

The firing tool 140 may include a mount 115, a blade 190, springs 180, wherein the blade 190 may be configured to attach to the mount 115 with springs 180 or other tensioners. The firing tool 140 may also include a guide 125 that the blade 190 and the mount 115 to slide along in some examples. The guide 125 may include a rail, slot, or other mechanical guide 125 for the blade 190 and/or mount 115 to slide along inside the firing tool 140. The firing tool 140 also may include a handle 160 that is configured to slidly fit into (or attach to) the guide 125 for retracting the mount 115 and cocking the firing tool 140 so that a hook or other apparatus may retain the mount 115 and blade 190 in a cocked position with the spring 180 or other tensioner compressed or extended in preparation for filing.

[0054] In some examples, the firing tool may be attached at various depths with respect to the sample cube 110 to allow for additional adjustments in the depth of the shave. In other examples, the sample cube will contain an adjustable guide 125 that can raise or lower the blade 190 so that it is closer or further away from the orifice 170 to further adjust the depth the shave.

[0055] The spring 180 may be attached to a front of the firing tool 140 and the handle

160. When the user retracts the handle 160, the spring 180 may either compress or extend, while the blade moves away from the sample cube 110. Then, the firing tool may lock the blade 190 and mount 115 in an extended position into a safety 130 and/or firing button 150 is depressed to release the mount 115 and blade 190 so that the spring or other tensioner can accelerate the blade 190 towards the sample cube 110 and over the top (or in front) of a chosen orifice 170 on the sample carriage in order to cut a skin sample that is being held in place by the orifice 170.

[0056] In other examples, air pistons may be used in place of a spring 180, and a compressor may provide air pressure to build up in a chamber into it is released by the firing button 150, for example, and the blade 190 is pushed forward along a piston 125. In other examples, an electromagnet may become energized by the firing button 150, which would attract a metal or magnetic portion of the mount 115 to another metal or magnetic portion on the firing tool 140 or the sample cube 110. In some examples, springs are not used and the user may press or slide the blade with the handle 160 manually.

[0057] FIG. 2 illustrates an example of a firing tool 140 that is constructed in accordance with the principles of the present disclosure. The firing tool 140 includes springs 180, mount 1 15, and handle 160. In this example, the handle 160 may be retracted to compress the springs 180 inside of the firing tool 140, which moves the blade 190 and mount 115 longitudinally along the guide 125 and then locked into place with the spring 180 compressed.

[0058] FIG. 3 illustrates another example of the biopsy system that is constructed in accordance with the principles of the present disclosure. The biopsy system includes a handle and linear sample carriage 120. The sample carriage 120 includes several different orifices 170 that may include increasing diameters from left to right. In another embodiment of the present disclosure, the orifices 170 may be same size, deceasing in diameters from right to left, or different size throughout. In other examples, the orifices 170 may be rectangle, triangle, half circle, or other suitable shapes.

[0059] FIG. 4 illustrates an example of the biopsy system 100 that is constructed in accordance with the principles of the present disclosure. The biopsy system 100 includes a sample carriage 120 inserted inside the sample cube 110. As shown, the firing tool 140 may be configured to be angled up away from the skin for ease of use (to allow users to get their fingers around the firing tool and the skin that the sample cube 110 presses against). The angle may include, e.g., less than or equal to 30 degrees or greater than 30 degrees. There may also be a "cocking" mechanism to load one or more springs (not shown) within the firing tool 140 (as shown in, e.g., FIG. 1) and a safety button 150 that prevents accidental firing. When fired (or when safety button is pressed), the firing tool 140 propels the "sled and razor assemblage" within in the cube (as shown in, e.g., FIGS. 1-2), the sample cube 110 may pop out (or dissemble from the firing tool 140) and a new sample cube can be put in allowing for multiple skin lesion biopsies with one firing tool. The firing tool 140 may be size of average hand (or customized as needed) and the firing button 140 may be configured to be released by pressing of the health providers thumb (or another finger).

[0060] FIGS. 5 and 6 illustrate perspective views of sample cube 110 that includes a slot 600 for receiving a sample carriage 120.

[0061] In FIG. 6, a side view of the sample cube 100 is illustrated that is constructed in accordance with the principles of the present disclosure. The sample cube 100 shows the slot 600 and rails 610 for the slot 600. The slot 600 may take many other suitable forms, or may simply be a snap fit apparatus that the sample carriage 120 into in different positions. In some examples, the slot 600 or other portions of sample cube 100 may contain stops or other indications when the sample carriage 120 is properly aligned inside the sample cube 110. In many examples, the top of the sample cube 110 is transparent, or may have a magnifying glass feature so the user can properly position an orifice over a skin malady.

[0062] FIG. 7 A illustrates an example of a sample carriage 120 that is constructed in accordance with the principles of the present disclosure. The sample carriage 120 includes a top view of the sample carriage 120 as disclosed herein. In this example, the sample carriage 120 includes several different orifices 170 of different sizes. Different sizes and different amounts of pressure applied to the sample carriage 120 on the skin will allow for different sized biopsies to be taken. FIG. 7B illustrates an example end view of the carriage 120 that includes the orifices 170, where the orifices 170 have an angle to their rims. In some examples, the angle may be an angle inclined as shown or in the opposite direction. For instance, the orifice 170 may be wider at the skin contact side than the razor side. In other examples, the orifice 170 may be wider at the blade 190 side which may help retain the skin after the blade 190 cuts it off.

[0063] FIG. 8 illustrates an example of a method for performing a biopsy that is constructed in accordance with the principles of the present disclosure. The method first includes first retracting the rod 160 to cock the cutting tool (Step 800). As indicated, this may be performed manually, with different examples of springs, tensioners, hydraulics, or electromagnets. This may also be done automatically with a pre-programmed (or predetermined) setting. Then, the user may manipulate (e.g. slide, rotate, press fit, lock into place) the carriage 120 to select the appropriate sized orifice for the biopsy (Step 810).

[0064] Then, the user may position tool on skin over the biopsy target (Step 820). In some examples, the user may look through the transparent top of the sample cube 110 while lining up an orifice 170 on the sample carriage 120 with the user's skin malady.

[0065] Then, once in place, the user may press down on the sample cube 110 or activate the vacuum to raise the user's skin (Step 830). In some examples, this may include a pneumatic system that also has a method of creating a vacuum for either cocking the firing tool or raising the skin. In some examples, the cube 110 may include a transparent side portion as well so the user can determine the amount of force necessary or when sufficient vacuum has been created to sufficiently raise the user's skin. In some examples, a vacuum may be created with a ball system or a plunger that is retracted inside a piston that is in gaseous communication with the inside of the chamber. In those examples, the sample cube 110 may contain a bottom that forms a seal over the skin using rubber or some other material. In some examples, a light guide or other optics will be used to show the user how far the skin has risen above the sample carriage 120 for firing.

[0066] Then, in some examples, once in proper position, the user may (optionally) press a safety release and then press the fire button to take the biopsy (Step 840). Then, the blade 190 and mount 115 will rapidly slide forward into the sample cube so that the blade slides over or very near the sample carriage 120 and cuts off the skin malady. In some examples, only a very thin slice or shave of the skin malady is needed to test for the laboratory. In examples where a vacuum is used, the connection between the sample cube 110 and both the sample carriage 120 and firing tool 140 will be airtight, so that a vacuum will be maintained when firing the firing tool.

[0067] Then, once cut the malady 180 or portion of malady that is shaved off may remain on top of the blade 190. In other examples, the blade may be retracted and the shaved off sample may be retained in the sample carriage 120 and or the sample cube 110. It should be noted that the sample cube 110 may be any suitable shape including cube, box, rectangular, spherical or other suitable shapes. In some examples, the bottom of samples cube 110 may contain a form fitting feature that fits the curves of the user's body.

[0068] FIG. 9 illustrates an additional embodiment of a shave biopsy system that is constructed in accordance with the principles of the present disclosure. The shave biopsy system includes a cube 110 that includes a once size orifice 170 that is embedded in a base plate 905, and does not include a sample carriage 120. In this example, the sample cube 110 itself contains an orifice 170 that is sized for a particular use or a particular lesion. This will allow the sample cube 110 to contain a label for the size of the lesion, and reduces the moving parts and opportunity for operator error. For instance, the different cubes 110 with different orifice 170 sizes may be sized for particular biopsy sites such as the arm, leg back, etc. In some examples, the system may have a ready and "locked out" safety to prevent accidental firing.

[0069] In some examples, the cube 110 may include a proximity sensor that locks out the firing mechanism through an electromechanical lock (or in some examples does not allow an electromechanical firing system to fire. For instance, the cube 110 and/or carriage 120 may contain a proximity sensor that determines whether skin is positioned through the orifice 170. For instance, a laser beam or other radiation source may emit radiation from one side of the orifice 170 or base 905, and be reflected by a mirror or detector on the other side.

[0070] If the detector does not detect the reflection or the direct beam or radiation, then the lock out mechanism may be disabled. In some examples, this may cause a light or other indicator to indicate the device is armed and ready to fire. In some examples, the safety mechanism is connected to the firing tool (at least the light emitting and detection portion) and perhaps only a mirror or other reflective surface is included in the disposable cube 110 portion.

[0071] In some examples, the light and reflective will have a beam of light that is just above or just below the orifice 170. In some examples, the detector may analyze the signature of the broken light beam to determine whether it is only a skin bubble, or a finger or too much skin is through, which would not disable the firing mechanism.

[0072] In some examples, the system may be a resposable system. For instance, the cube 110 may be a single disposable use while the firing tool 140 may be reusable, or may be a combination of reusable (the firing mechanism) and disposable parts (the blade 190) as well. Accordingly, in some examples, if the cube 110 has a single orifice 170, the firing tool could be utilized to cut off the lesion, and drawer 910 may close within the cube 110 that slides above the orifice 170 between the patient's skin and over the top of a base plate 905.

[0073] The drawer 910 top side that would contact the patient's skin through the orifice 170 after firing, may include a hemostatic agent in some examples, that could help coagulate the lesion after the biopsy. In some examples, other portions of the blade 190 or the mount 115 may include a hemostatic agent, depending on the position of the parts after firing (e.g. the amount of travel distance after the blade 190 has passed the orifice 170).

[0074] In some examples, the entire cube 110 may be disposed in a fixative solution of 10% formalin and sent to a pathologist for diagnosis. For instance, in the embodiment where the cube 110 itself has an orifice 170 and a drawer 910 closes above the orifice 170, the drawer 910 could seal after firing and solution could enter the cube 110 from pores 915 in the cube 110.

[0075] In some examples, the cube 110 may form a watertight seal once the drawer

910 has closed after firing. This way, a fixative could be added from a top portion of the cube 110, and then the cube itself could be shipped for analysis. For instance, pores 915 or other openings or slots on the top or near the top of the cube 110 may provide an opening to dispense the fixative solution.

[0076] In some examples, the cube 110 may also have a removable side, so that the biopsied skin may be removed easily after arriving at the lab or after the specimen is fixed. In other examples, the same opening 915 used to pour the fixative may be large enough to remove the specimen of the patient's skin with a tweezers or other tool. In some examples, the cube may have finger grips, or a rubber or other suitable coating for handling. In some examples, the blade 190 and other firing components will be at the bottom of the firing tool 140. This will allow the firing tool 140 to be flush with the skin.

[0077] In other examples the firing tool 140 may be very short or angled to allow the user to take biopsies from hard to reach areas, such as near joints, etc. For instance, the firing tool 140 may be integrated with the cube 110, so that the spring or other firing mechanism is inside the tube and pulls the blade across the cube 110. Adjustable Depth Biopsy

[0078] In some examples, a biopsy system 100 may be provided that can allow for adjustable depth shave biopsies. For instance, in order to perform Moh's technique, the surgeon may be required to perform multiple depth biopsies. Particularly, after each time the surgeon shaves off a layer, the newly shaved layer is checked for cancer cells to determine whether additional layers need to be removed.

[0079] Accordingly, a system that allowed for adjustable depth shaves would be advantageous and allow a caregiver to take progressively deeper, controlled shaves. Currently, surgeons pinch razor blades between their thumb and finger to curve the blade so that deeper biopsies may be taken. However, this is unpredictable and not as reliably reproducible or accurate.

[0080] Therefore, a need exists for a system then can take progressively deeper shaves with more precision and repeatability. In some examples, this will allow the surgeon to take shaves that are thinner than currently possible by manipulating a razor with their bare hands. Accordingly, the following systems and methods are developed as exemplary adjustable depth shave biopsy systems.

[0081] FIG. 10 illustrates an example of a sample cube 110 with an adjustable depth razor 190. In this case, the system has a flexible blade 190 that includes a blade attachment 1010 on both sides of the blade 190. The attachment 1010 includes a squeezing mechanism 1000 that pushes the attachments 1010 together so that the blade 190 bends downward. This allows the blade 190 to take deeper and deeper shaves as the squeezing mechanism 1000 pushes the blade 190 to bend further inward.

[0082] FIG. 10 also illustrates a detector 1020 that determines the distance from the bottom of the cube 110 or cutting surface to the patient's skin. For instance, a proximity sensor using infrared or laser beams may be utilized to judge the current distance. This information could be displayed on a display, or could be used to adjust the depth based on depth settings. Any suitable proximity sensors could be including sensors that emit electromagnetic fields, electromagnet radiation like infrared, ultrasonic, and others that have suitable precision and accuracy based on the tolerances of shave biopsies. [0083] FIG. 11 illustrates a side view of the system depicted in FIG. 10 that includes an actuator 1100 for pushing the mechanism 1000 closer together. In some examples, the actuator 1100 and/or mechanism 1000 will be a mechanical feature that pushes against a spring or some other retaining member. For instance, the actuator 1100 may be a lever that a user can push or pull that will squeeze the blade 190 by applying pressure to the mechanism 1000 and attachment 1010.

[0084] In some examples, the actuator 1100 may be locked in at certain spots to keep the blade 190 squeezed at the same level. The actuator 1100 and/or mechanism 1000 and attachment 1010 may be either mechanical or electromechanical. For instance, an actuator 1100 and/or mechanism 1000 may be an electromechanical mechanism that pushes or squeezes the blade 190 on one or both sides so that it bows down further. This will allow the mechanism to automatically adjust to certain depth of shaves. The strength of spring may be reversed (or customized) for body parts, e.g., back skin would need a stronger spring and ace a weaker spring.

[0085] In some examples, the spring may include different strengths for different areas of the body. For instance, for back skin a weaker spring may be used as deeper cuts would likely be necessary. In other examples, a stronger spring may be used for scalp or face biopsies where the cuts will likely be shallower.

[0086] In some examples, the system may change the depth during a shave. For instance, information fed back from the detector 1020 that includes the current depth of the cut based on the current distance to the skin (and calculating the depth of the blade 190 underneath the skin). This feedback mechanism may automatically adjust the depth of the shave, in any of the electromechanical depth actuators that are disclosed herein.

[0087] In some examples, the system may also track the forward distance travelled and follow a depth program that moves the blade deeper in the middle of the distance. For instance, the system 100 could be set to take a shave of 2 inches, and start increasing the depth at ¾ of an inch, and then start decreasing the depth at 1 inch, or other suitable depths.

[0088] FIG. 12 illustrates an example of a blade on a hinge embodiment that allows the blade to rotate in a half circle or other suitable trajectory. In this example, the blade 190 connects to an arm attached to a joint 1200 that either pushes the blade 190 or allows the blade to rotate so that the user can advance the blade 190 through a shave procedure, for example with a handle. This may be an electromechanical joint 1200 or could be a mechanical joint that relies on the operator to push the blade 190 through the skin to perform the shave biopsy.

[0089] In some examples, the blade 190 may be flat, or may be curved as other examples described herein. For instance, the blade could change its curvature during the trajectory to get a precise shave based on the skin malady for a specific patient. In some examples, if the blade is curved it may be directly or near directly attached to the joint 1200. Otherwise, an arm or pair of arms may connect to the blade 190 to the joint 1200. In some examples, the arm itself may include a blade edge.

[0090] FIG. 13 illustrates an additionally embodiment of a shave biopsy system 100 that utilizes a circular shave system that rotates around a center post to progressively shave deeper as needed. Here, a physician may set the block 110 on the patient's skin and insert staff 1300 at the center of the lesion or other skin malady. The blade 190 may then be swiveled around the staff 1300 by using the handle 1320 to shave malady. Then, a center portion that was not cut at the position of the staff 1300 could be removed using a scissors or free blade 190.

[0091] In this example, the blade 190 edge may be curved and angled downward as attached to a handle 1320. In some examples, this will allow larger circumference of shave by pushing the blade 190 further down so more of the blade 190 contacts the skin. In some examples, the handle 1320 will be free. In others, the handle 1320 may move along an adjustable track 1310. The adjustable track 1310 may allow the depth of the shave to be adjusted. This way, the user could pre-adjust the desired depth, and then move the handle 1320 around the track 1310 after positioned on the skin malady.

[0092] FIG. 14 illustrates another example of a skin biopsy system 100 that utilizes an adjustable depth blade 190. In this example, the blade 190 does not bend, but is a straight blade that may be adjusted lower depending on the depth of the shave. In other examples, the blade 190 may be both adjustable by extending it down and bending it or blade 190 may be a curved blade 190. In this example, there is a plate 1410 that slides on the surface of the skin so that the proper depth of shave is assured, much like a cheese slicer. [0093] In some examples, the blade 190 will be attached to an adjustment mechanism

1400, by an arm 1420. The arm 1420 may be attached on the ends of the blade 190, and in some cases the arm may also have a blade edge.

[0094] The adjustment mechanism 1400 may be any suitable mechanism that can lower the arms 1420 and blade 190. For instance, the adjustment mechanism 1400 may be a mechanical dial mechanism that uses gears or other mechanical means to lower down the arms 1420. In other cases, the adjustment mechanism 1400 may be electromechanical and may receive feedback from a depth detector 1020.

[0095] In some examples, the blade 190 will be a very thin and short blade 190 that will allow for easy changes in depth. For instance, the blade from edge to back may only be a few mm. Additionally, the adjustment mechanism 1400 may also be able to tilt the blade 190 to change direction more easily, especially in the electromechanical configuration.

[0096] FIG. 15 illustrates another example of a shave biopsy system 100 that includes a track 1500 for sliding the blade 190 while the sample cube 110 is stationary. In this case, the track 1500 may be an adjustable track, that allows a straight or curved blade 190 to travel along with a handle 1510 or tab that can be advanced along the track 1500.

[0097] The handle 1510 may be attached to the arm 1520 that is attached to the blade

190. This will allow the blade 190 to be pushed by the handle 1510. In some examples, and as illustrated in FIG. 15, the track 1500 may include a dip or depression, so the shave will be deeper in the middle. This embodiment is advantageous, because the cube 110 may be firmly held against the patient's skin while the handle 1510 is advanced.

[0098] In other examples, the blade 190 may be extended by extending arm 1520 from handle 1510 or other adjustment mechanism as disclosed herein. That way, the track 1500 may be stationary, and a deeper shave can be achieved through extending the blade 190 rather than moving the track 1500. In other cases, the blade will be fixed and the track can move up and down or even change shape depending on the type of shave needed.

[0099] As many embodiments of the shave biopsy system 100 have been described independently above, it is notable that many features of each embodiment may be combined and mixed. For instance, the deformable blade 190 can be added to many of the other embodiments. Other features that may be added include the depth sensor 1020 and others. [00100] FIG. 16 illustrates another example that may be utilized with many of the embodiments above. In this example, the system may include different base plates 1600, wherein each base plate 1600 may include different sized or shaped orifices 1630. In some examples, the base plate 1600 could include an adhesive so it can be stuck onto a patient's body with the lesion or other malady first centered in the orifice 1630.

[00101] Accordingly, then the same cube 110, can be connected to the base plate 1600 at the connections 1610 on the base plate 1600 and on the sample cube 110. Then, the blade 190, in the various configurations described herein, could be actuated to cut the patient's skin and the malady through the orifice 170 and orifice 1630. Accordingly, this allows the base plate 1600 to be first centered to increase the accuracy of the placement of the cube and orifice over the malady. Then, the various configurations and embodiments of the blade 190 and various actuators could be applied to this embodiment.

[00102] In other examples, the base plates may include numbers or letters to allow for selection of the correct size. For instance, if the operator would like a wider or deeper cut for a second or subsequent shave, the operator could select them in sequence.

[00103] FIG. 17 illustrates another example system that uses a flexible blade 190 that rotates around a support 1705. In some examples the flexible blade 190 is positioned off- axis, so it eccentrically rotates around the support 1705. The blade 190 may be connected to the support 1705 with to blade adjusters 1710. The blade adjusters 1710 may both move to adjust the depth and shape of the cut of the blade.

[00104] The blade adjusters 1710 may be mechanical, electromechanical or use other technology to move and size the blade. For instance, the blade adjusters 1710 may include a screw and thread arrangement that allows an operator to change the sizing by turning the blade adjuster 1710. In other examples, blade adjusters 1710 may electromechanically change or move along the support 1705, to change shape. In this example, the blade adjusters 1710 may be able to move during operation or to take successively deeper shaves during a Moh's procedure.

[00105] The blade 190 may be positioned so that when rotating a portion of it protrudes below the orifice 170. In some examples, the support 1705 may also be able to be moved or rotated mechanically be the operator or automatically, this could allow the operator to make and change the cut depth while the blade 190 is spinning around the support 1705. [00106] In some examples, the blade 190 may spin around the support 1705 at different speeds. For instance, a slower speed could be utilized for a focused shaved (partial or 360). The system may also include a fast speed spinning that would actually take very thin layers successively during a single cut instead of taking one single cut. This could have many advantages. First, this would allow the operator to observe during the cut how many layers are being removed and how many deeper shaves need to be taken in real time. This could allow the operator to more efficiently and accurately shave the exact amount of tissue.

[00107] Additionally, the thin shaves could be applied to a Per chip to diagnose malignancy quickly, without having to use microscopic analysis. For instance, the shaving may be so fine that they form or break apart into a powder. This would allow for application to a Per chip, which could quickly determine whether additionally shavings need to be taken. Accordingly, at some point, the shavings would be determined no longer to contain malignancy, and the procedure could be stopped.

CONCLUSIONS

[00108] The various methods and techniques described above provide a number of ways to carry out the invention. Of course, it is to be understood that not necessarily all objectives or advantages described can be achieved in accordance with any particular embodiment described herein. Thus, for example, those skilled in the art will recognize that the methods can be performed in a manner that achieves or optimizes one advantage or group of advantages as taught herein without necessarily achieving other objectives or advantages as taught or suggested herein. A variety of alternatives are mentioned herein. It is to be understood that some embodiments specifically include one, another, or several features, while others specifically exclude one, another, or several features, while still others mitigate a particular feature by inclusion of one, another, or several advantageous features.

[00109] Furthermore, the skilled artisan will recognize the applicability of various features from different embodiments. Similarly, the various elements, features and steps discussed above, as well as other known equivalents for each such element, feature or step, can be employed in various combinations by one of ordinary skill in this art to perform methods in accordance with the principles described herein. Among the various elements, features, and steps some will be specifically included and others specifically excluded in diverse embodiments. [00110] Although the application has been disclosed in the context of certain embodiments and examples, it will be understood by those skilled in the art that the embodiments of the application extend beyond the specifically disclosed embodiments to other alternative embodiments and/or uses and modifications and equivalents thereof.

[00111] In some embodiments, the terms "a" and "an" and "the" and similar references used in the context of describing a particular embodiment of the application (especially in the context of certain of the following claims) can be construed to cover both the singular and the plural. The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein. All methods described herein can be performed in any suitable order unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and all examples, or exemplary language (for example, "such as") provided with respect to certain embodiments herein is intended merely to better illuminate the application and does not pose a limitation on the scope of the application otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the application.

[00112] Certain embodiments of this application are described herein. Variations on those embodiments will become apparent to those of ordinary skill in the art upon reading the foregoing description. It is contemplated that skilled artisans can employ such variations as appropriate, and the application can be practiced otherwise than specifically described herein. Accordingly, many embodiments of this application include all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described elements in all possible variations thereof is encompassed by the application unless otherwise indicated herein or otherwise clearly contradicted by context.

[00113] Particular implementations of the subject matter have been described. Other implementations are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve desirable results. In addition, the processes depicted in the accompanying figures do not necessarily require the particular order shown, or sequential order, to achieve desirable results. [00114] All patents, patent applications, publications of patent applications, and other material, such as articles, books, specifications, publications, documents, things, and/or the like, referenced herein are hereby incorporated herein by this reference in their entirety for all purposes, excepting any prosecution file history associated with same, any of same that is inconsistent with or in conflict with the present document, or any of same that may have a limiting affect as to the broadest scope of the claims now or later associated with the present document. By way of example, should there be any inconsistency or conflict between the description, definition, and/or the use of a term associated with any of the incorporated material and that associated with the present document, the description, definition, and/or the use of the term in the present document shall prevail.

[00115] In closing, it is to be understood that the embodiments of the application disclosed herein are illustrative of the principles of the embodiments of the application. Other modifications that can be employed can be within the scope of the application. Thus, by way of example, but not of limitation, alternative configurations of the embodiments of the application can be utilized in accordance with the teachings herein. Accordingly, embodiments of the present application are not limited to that precisely as shown and described.

Claims

1. A skin biopsy system, the system comprising: a sample cube comprising a bottom portion and a top portion; a sample carriage configured to connected to an area between the bottom and the top portion of the sample cube, the sample carriage comprising at least two different sized orifices; and a firing tool connected to the sample cube, the firing tool comprising a bottom portion and a top portion, wherein the firing tool further comprises: a mount on a bottom portion of the firing tool that is configured to be connected to the top portion of the sample cube thereby placing the firing tool directly on the top portion of the sample carriage; a blade connected to the mount, wherein the blade is configured to project outwardly from the mount when depressed and retract inside the firing tool when compressed; a tensioner connected to the mount and the blade; a guide that the mount slides on, the guide comprising at least one of: a guide, a slot, and any other mechanical guide; and a firing button that is connected to the blade and the tensioner.

2. The skin biopsy system of claim 1, wherein the tensioner is a spring.

3. The skin biopsy system of claim 1, wherein the top portion of the sample cube is transparent.

4. The skin biopsy system of claim 1, wherein the at least two different sized orifices are circular.

5. The skin biopsy system of claim 1, wherein firing tool further comprises a handle connected to the mount.

6. The skin biopsy system of claim 5, wherein the handle may be retracted to compress the tensioner inside of the firing tool, which moves the blade and the mount longitudinally along the guide and then lock into place with the tensioner compressed to build up pressure, which is depressed by activating the firing button.

7. The skin biopsy system of claim 1 further comprising a vacuum source connected to the sample cube so that a patient's skin raises above the orifice on the sample carriage when the vacuum source is activated.

8. The skin biopsy system of claim 1, wherein the sample cube comprises at least one transparent side.

9. The skin biopsy system of claim 1, wherein the blade is positioned to slide on the top portion of the sample carriage when fired.

10. The skin biopsy system of claim 1, wherein the sample cube has a slot that slidably receives the sample carriage to connect the sample carriage to the sample cube.

11. A method of performing a shave biopsy on a patient's skin, the method comprising: positioning a sample carriage on the skin, the sample carriage comprising at least one orifice; connecting the sample carriage to a sample cube, the sample cube comprising a bottom portion, a top portion, and a slot between the bottom portion and the top portion of the sample cube, wherein the sample carriage is configured to slidly fit into the slot; connecting the sample cube to a firing tool, wherein the firing tool comprises: (a) a mount on a bottom portion of the firing tool that is configured to be connected to the top portion of the sample cube thereby placing the firing tool directly on the top portion of the sample carriage, (b) a blade connected to the mount, wherein the blade is configured to project outwardly from the mount when depressed and retract inside the firing tool when compressed, (c) a tensioner connected to the mount and the blade, (d) a guide that the mount slides on, the guide comprising at least one of: a guide, a slot, and any other mechanical guide, and (d) a firing button that is connected to the blade and the tensioner; applying force to the sample cube so that a portion of the patient's skin raises above the at least one orifice on the sample carriage; and depressing the firing button to cause the blade to cut off the portion of the patient's skin that is raised above the sample carriage.

12. A method of performing a shave biopsy on a patient's skin, the method comprising: positioning a sample carriage on the skin, the sample carriage comprising an orifice; connecting the sample carriage to a sample cube, the sample cube comprising a bottom portion, a top portion, and a slot between the bottom portion and the top portion of the sample cube, wherein the sample carriage is configured to slidly fit into the slot; connecting the sample cube to a firing tool, wherein the firing tool comprises: (a) a mount on a bottom portion of the firing tool that is configured to be connected to the top portion of the sample cube thereby placing the firing tool directly on the top portion of the sample carriage, (b) a blade connected to the mount, wherein the blade is configured to project outwardly from the mount when depressed and retract inside the firing tool when compressed, (c) a tensioner connected to the mount and the blade, (d) a guide that the mount slides on, the guide comprising at least one of: a guide, a slot, and any other mechanical guide, and (d) a firing button that is connected to the blade and the tensioner; applying a vacuum source to the sample cube so that a portion of the patient's skin raises above the orifice on the sample carriage; and depressing the firing button to cause the blade to cut off the portion of the patient's skin that is raised above the sample carriage.

13. The method of claim 12 wherein the vacuum source is a plunger.

14. The method of claim 12 wherein the vacuum source is a ball based system.

15. The method of claim 12 wherein the portion of the patient's skin is placed in fixative solution after being cut off.

16. The method of claim 12 wherein at least one of the sample carriage, the sample cube, and the firing tool are placed into fixative solution after the portion of the patient's skin is cut off.

17. The method of claim 12 wherein the orifice is one of at least two orifices and further comprising manipulating or positioning the sample carriage to position the orifice in a cutting path of the blade.

18. The method of claim 17 wherein manipulating comprises sliding.

19. The method of claim 17 wherein manipulating comprises rotating.

20. A skin biopsy system, the system comprising: a sample cube with a base plate that contains an orifice; a firing tool connected to the sample cube, the firing tool comprising: a mount; a blade connected to the mount; and a firing mechanism.

21. The skin biopsy system of claim 20, wherein the sample cube comprises a drawer that slides below the base plate and is configured to close open firing of the firing tool.

22. The skin biopsy system of claim 21, wherein the drawer forms a water tight seal with a wall of the sample cube when closed.

23. The skin biopsy system of claim 21, wherein the drawer comprises a hemostatic agent on a top side of the drawer.

24. The skin biopsy system of claim 20, wherein sample cube comprises a pore.

25. The skin biopsy system of claim 20, wherein the sample cube comprises a pressure activated light.

26. The skin biopsy system of claim 20, wherein the sample cube is disposable and the firing tool is reusable.

27. The skin biopsy system of claim 20, further comprising a safety mechanism that prevents the firing mechanism from firing.

28. The skin biopsy system of claim 27, wherein the safety mechanism comprises a radiation emitter and detector.

29. The skin biopsy system of claim 28, wherein the radiation emitter and the detector are positioned to have a beam pass just over the orifice.

30. The skin biopsy system of claim 28, wherein the radiation emitter emits a laser light.

31. The skin biopsy system of claim28, wherein the radiation emitter is positioned to emit the laser light in a direction that will reflect off of a reflective surface.

32. A skin biopsy system, the system comprising: a sample cube; and a deformable blade configured to be connected to the sample cube, wherein the deformable blade is connected to a pushing mechanism configured to apply force to the deformable blade.

33. The skin biopsy system of claim 32, wherein the pushing mechanism is configured to deform the deformable blade at 1 mm increments.

34. The skin biopsy system of claim 32 further comprising a depth detector that provides electromechanical feedback.

35. The skin biopsy system of claim 32, wherein the pushing mechanism is electromechanical.

36. The skin biopsy system of claim 32, wherein the pushing mechanism includes a mechanical lever system.

37. The skin biopsy system of 34, wherein the pushing mechanism adjusts the deformable blade based on electromechanical feedback from the depth detector.

38. The skin biopsy system of claim 32, wherein the sample cube comprises an orifice, and the blade is position to deform and extend down through the orifice.

39. The skin biopsy system of claim 32, the sample cube comprises a pair of arms that are connected at their respective joints on the sample cube to allow the deformable blade to rotate in a cutting trajectory.

40. A skin biopsy system, the system comprising: a sample cube with an orifice; a blade connected to a staff, and wherein the blade is rotatable around the staff; and a handle connected to the blade.

41. The skin biopsy system of claim 40, wherein the orifice comprises a track around its diameter, and the handle is configured to travel in the track to guide the blade rotation.

42. The skin biopsy system of claim 41, wherein the track includes an adjustment mechanism to allow the handle to travel higher or lower around the track.

43. A skin biopsy system, the system comprising: a sample cube with a top portion and a bottom portion; a sliding plate connected to the bottom portion inside the sample cube; and a blade connected to a pair of arms and positioned below the sliding plate, and wherein the arms are connected to an adjustment mechanism configured to raise and lower the blade.

44. The skin biopsy system of claim 43, wherein the adjustment mechanism is at least one of: a mechanical dial based mechanism, an electromechanical, and a pushing mechanism.

45. A skin biopsy system, the system comprising: a sample cube; a blade support connected to the sample cube and configured to be placed inside the sample tube with at least one orifice; and a flexible blade connected to the blade support and configured to protrude below the at least one orifice when the flexible blade is rotated by the blade support; and at least one blade adjuster positioned near at least one connection point of the flexible blade to the blade support.

46. The skin biopsy system of claim 45, wherein the blade support is positioned at an angle to the horizontal.

47. The skin biopsy system of claim 54, further comprising a motor connected to the blade support that is configured to spin the blade support and thereby the flexible blade.

48. A method of performing a shave biopsy on a skin of a patient, the method comprising: positioning a base plate on the skin of a patient, wherein the base plate has an orifice of a first diameter; connecting a sample cube to the base plate; connecting a fire tool comprising a blade actuator and a blade to the base plate and the sample cube, wherein the blade is connected to the blade actuator; and initiating the blade actuator to move the blade inside the firing tool to cut off the portion of the patient's skin that is raised above the orifice.

49. The method of claim 57, further comprising: attaching a second base plate with a second diameter larger than the first diameter on the patient's skin, the sample cube is connected to the second base plate; and

Initiating the blade actuator is a second time to perform a deeper cut on the skin of the patient.