Punch biopsy tool

Abstract

The present invention relates to a combination punch biopsy tool comprising both cutting means cutting a biopsy or sample from a cutaneous or mucosal surface, and a gripping part for catching and safe-handling of the biopsy or sample. In particular, the present invention relates to a punch biopsy tool for providing a skin or mucous membrane or tissue sample (15) comprising a cutting edge (1) and gripping means (2, 2a, 2b) for gripping a biopsy sample, wherein the cutting edge (1) is positioned at a first end of the punch biopsy tool, while the gripping means (2, 2a, 2b) are positioned at a second end of the punch biopsy tool, both the cutting edge (1) and the gripping means (2, 2a, 2b) are secured to a central body.

Description

Punch biopsy toolThe present invention relates to a combination punch biopsy tool comprising both cutting means cutting a biopsy or sample from a cutaneous or mucosal surface, and a gripping part for catching and safe-handling of the biopsy or sample.In particular, the present invention relates to a punch biopsy tool comprising both a cutting edge and gripping means for gripping a biopsy or sample which offers optimization of both parts. Also, the gripping means may comprise a secondary cutting edge replacing a separate scissor or knife for cutting the sample loose, i.e. a biopsy tool according to the invention may comprise a two-in-one tool or a three-in-one tool.Background of the inventionToday a normal way of obtaining a skin punch biopsy is to apply a series of tools, a punching device comprising a punching part provided with a cutting edge normally creating a cylindrical biopsy in an angle perpendicular to the skin surface, a gripping device such as a pair of tweezers gripping the biopsy after having removed the punching device, and a cutting tool which is used to free the biopsy at the bottom while holding the biopsy with the gripping device, which cutting tool may be a pair of scissors.All tools used to prepare a biopsy are either discarded after use or are cleaned and autoclaved. When using two or three tools made primarily of stainless steel, both procedures are very expensive and environmental unfriendly, especially in the scenarios were all the tools are discarded. Another issue with the current punch biopsy procedures is that the punch diameters may vary from 2-12 mm and there are no gripping devices that match those different diameters. A standard tweezer is used for all sample sizes, which makes the sampling of the tissue challenged in several situations depending on the tissue viscosity. In some cases, the sample may break because of a bad fit between the size of the gripping device and the tissue and in other cases the sample may become damaged because it is being squeezed in the gripping, which damages the tissue and thus gives a more unprecise diagnostic.It is known to combine a skin cutter with a gripping device. US 52009755 A discloses a skin cutter instrument for excising ellipsoid-shaped samples of skin from a patient. The skin cutter comprises a central hollow tube, a spring and rod combination within the tube. Also, it comprises gripping means combined with the skin cutting means comprising an assembly with multiple pivotable joints, and two skin cutting blades. The assembly carries out a scissoring motion when the rod is pressed down, causing the blades to come together and thereby remove the skin sample. The blades can have either concave cutting surfaces or straight cutting surfaces that are deformed into an arc shape. Either blade cutting surface configuration allows for excision of the desired ellipsoid-shaped tissue sample from the patient. As the skin cutting blades cut through the skin in an angle at least partly parallel to the skin surface, it is not possible to cut deep without removing too much surface skin and there by delay healing of the wound and risk forming large scars.US 4.122.855 Al discloses a cutting tool for forming sockets in the skin of the scalp of a person. The cutting tool includes a handle (12) having a detachable hollow tubular head (22) open at both ends. The head has a knife edge (26) at one end thereof and is formed with at least one bleed hole (32) extending through a side wall of the head. According to an embodiment, the cutting tool may comprise a pair of opposed spring arms (40, 40') extending longitudinally of the handle and along opposite sides thereof and terminate at free ends defined by an inwardly turned pointed prongs (42). The prongs are pressed against each other and prevents a plug cut from the skin from falling out the head as the tool is lifted away from the skin. This cutting tool is not suitable for taking biopsies in general as the cutting tool cannot be used to remove a porous or fragile biopsy as the prongs would just slide through the matter.US 2009 / 0018467 Al discloses a punch biopsy apparatus for removing all or a portion of a suspect dermal growth. The punch biopsy apparatus comprises a hollow cylinder body (112, 212); a coring blade (122, 222) at the base of the hollow cylinder body adapted to cut vertically into the skin and at least one scooping blade (120, 220) pivotally secured by an axle and a pair of pivot seats within the cylinder body, the scooping blade is adapted to cut laterally through the skin, each scooping blade is semicircular. The scooping blades may help retain the biopsy sample (238) (see

[0052] ) while the sample is being removed, but retaining the sample by the narrow scooping blades will only be possible if the sample is constituted of solid tissue. The punch biopsy apparatus of this document does not comprise actual gripping means which are able to grab and hold a porous biopsy sample during removal.Hence, an improved biopsy tool would be advantageous, in particular a single biopsy tool comprising both a cutting means adapted to cut a specific biopsy size, and a gripping means adapted to catch and hold the cut biopsy.Summary of the inventionThus, an object of the present invention relates to providing a cheaper, more sustainable and more efficient punch biopsy tool for providing a sample from an outer layer of a human or animal body i.e. a sample from skin or mucous membrane. The tool makes it possible to remove a sample of a desired size from a tumour, even if the tumour comprises a porous structure from which it is difficult to remove a structured sample.Thus, one aspect of the invention relates to a punch biopsy tool for providing a skin or mucous membrane or tissue sample (15) comprising primary cutting means in form of or at least comprising a cutting edge (1) and gripping means (2, 2a, 2b) for gripping a sample (15), wherein the cutting edge(s) (1) is not part of the gripping means (2, 2a, 2b) and the cutting edge(s) (1) and the gripping means (2) are positioned at separate and independent positions and extending from a central part in a different direction.Thus, one aspect of the invention relates to a punch biopsy tool for providing a skin or mucous membrane or tissue sample (15) comprising cutting means at least comprising a cutting edge (1) and gripping means (2, 2a, 2b) for gripping a biopsy sample, wherein the cutting edge (1) is positioned at a first end of the punch biopsy tool, while the gripping means (2, 2a, 2b) are positioned at a second end of the punch biopsy tool, both the cutting edge (1)and the gripping means (2, 2a, 2b) are secured to a central body. I.e., the cutting edge(s) (1) is not part of the gripping means (2, 2a, 2b) making it possible both having a single instrument while also adapting both the cutting edge and the gripping means to a desired purpose.According to any embodiment of the invention, the cutting edge (1) is positioned at a first end of the punch biopsy tool, while the gripping means (2, 2a, 2b) are positioned at a second end of the punch biopsy tool, both the cutting edge (1) and the gripping means (2, 2a, 2b) are secured to a central body. The central body may comprise a handle (3) for cutting means comprising the cutting edge (1). In this context "central body" simply means that the central body is positioned between the cutting means and the gripping means.According to any embodiment of the invention, the cutting edge (1) positioned at the first end of the punch biopsy tool and gripping means positioned at the second end of the punch biopsy tool may be positioned at opposite ends i.e. may be positioned opposite relative to each other.According to any embodiment of the invention, the gripping means (2, 2a, 2b) may comprise two, three or more flexible or flexibly mounted arms (2a, 2b) which arms (2a, 2b) are configured to move toward each other during use until contact between the two or more arms is reached, and each arm comprises an inner surface (17) and an outer surface (16).According to any embodiment of the invention, an outer end of an outer portion (12) of each arm (2a, 2b) may comprise a protruding edge (7) which protruding edge (7) is configured to contact an opposite or converging arm when the arms (2a, 2b) are moved towards each other during use thereby providing a support for the sample (15) during gripping and / or removal. At least one protruding edge(s) (7) may comprise a cutting edge or cutting means.According to any embodiment of the invention comprising two, three or more flexible or flexibly mounted arms (2a, 2b), the inner surface (17) of the outer portion (12) of each arm or at least of one arm (2a, 2b) may be positioned at an angle a relative to the insertion direction used to make an insertion gap (15a), if the insertion direction is 0 degrees then the angle a is larger or equal to 0 degrees and smaller than 45 degrees (0° < a < 45°), normally 5° < a < 30°. The angle a is described relative to the "insertion direction", however, this direction may also be described as a longitudinally extending central axis or reference line of the gripping means as illustrated in fig. 4, 5A and 7C with a dotted line.According to any embodiment of the invention comprising two flexible or flexibly mounted arms (2a, 2b), the width of a present protruding edge (7) is smaller than the maximum crosssection e.g. the diameter, of the cutting edge (1).According to any embodiment of the invention comprising two flexible or flexibly mounted arms (2a, 2b), the protruding edges (7) are straight and the minimum length of the protruding edge (7) is at least 10%, or at least 20%, or at least 30% or at least 40%, or at least 50% or at least 60% or at least 65% or is around 70% of the maximum cross-sectional dimension of the sample (15), and / or is smaller than 100% of the maximum cross-sectional dimension of the sample (15), and / or is smaller than 90% of the maximum cross-sectional dimension of the sample (15), and / or is smaller than 80% of the maximum cross-sectionaldimension of the sample (15), and / or is smaller than 75% of the maximum cross-sectional dimension of the sample (15).According to any embodiment of the invention comprising two, three or more flexible or flexibly mounted arms (2a, 2b), the outer end portion (12) of one or of each arm (2a, 2b) comprises a recess or depression (8) at the inner surface (17) wherein the recess or depression (8) has walls connected either by a continuous curved junction (rounded corners) or by a discontinuous junction forming distinct edges (sharp angled corners).According to any embodiment of the invention comprising two, three or more flexible or flexibly mounted arms (2a, 2b), the outer end portion (12) of one or of each arm (2a, 2b) comprises a recess or opening along the inner surface (17) which recess or opening is provided as a distance (dO) between the longitudinally extending arms increases from the outermost protruding edge (7) creating a space between the opposing or converging arms.According to any embodiment of the invention comprising flexible or flexibly mounted arms (2a, 2b) as gripping means, the biopsy tool may comprise two opposing arms (2a, 2b) and the two opposing arms (2a, 2b) of the gripping means (2) may mirror each other and comprise an inclining outer surface (16) and an inclining inner surface (17) wherein the surfaces (16, 17) are inclined relative to the longitudinal direction defining an insertion direction, wherein the "insertion direction" corresponds to a longitudinally extending central axis of the gripping means.According to any embodiment of the invention, an outer end portion (12) of the gripping means (2, 2a, 2b) and a protruding edge (7) of the gripping means are adapted in size and / or perimeter to an insertion gap (15a) formed by the cutting edge (1) of the same biopsy tool and surrounding the sample (15), such that the outer end portion (12) of the gripping means fit around the sample (15) when inserted into the insertion gap (15a).According to any embodiment of the invention, the punch biopsy tool may comprise a punch part (4) comprising the cutting edge (1) and the punch part (4) comprises a longitudinally extending tube-like body having a round, ellipsoid or polyangular profile forming a round, ellipsoid or polyangular cutting edge (1) positioned at an outer end of the punch part (4). Normally, the punch part (4) is made of metal such as steel.According to any embodiment of the invention, the biopsy tool may comprise a safety cap (6) which may be positioned in at least two positions, a first retracted position relative to the cutting edge (1) where the safety cap (6) does not cover the cutting edge (1), and a second forward position relative to the cutting edge (1) where the safety cap (6) covers the cutting edge (1) and prevent contact with the cutting edge (1).According to any embodiment of the invention, the biopsy tool comprises a handle part (3) configured to be held by a user when moving the biopsy tool in an insertion direction cutting a profile and the length of a sample (15).According to any embodiment of the invention, the biopsy tool may comprise a plunger (10) comprising a front surface (11) facing forward in an insertion direction, which plunger (10) is configured to be in at least two positions, a first position where the plunger (10) is at a retracted position relative to the cutting edge (1) allowing for cutting with the cutting edge(1), and a second position where the plunger (10) is at a forward position where the front surface (11) of the plunger extends to or beyond cutting edge (1).According to any embodiment of the invention, the punch biopsy tool may comprise both a safety cap (6) and a plunger (10) which safety cap (6) and plunger (10) may be mechanically connected and move together with same velocity and in same direction.According to any embodiment of the invention, the biopsy tool may be either disposable or partly disposable or reusable.According to any embodiment of the invention, a handle part (3) for the cutting means, the gripping means (2) and an extending part configured to hold or mount a punch part (4) are manufactured in one piece by moulding such as injection moulding, or compression moulding, or blow moulding, or by thermoforming, or rotational moulding or by 3D-printing, CNC Machining or Extrusion and the punch part (4) comprising the cutting edge (1) is during manufacturing fixed to the extending part.According to any embodiment of the invention, the cutting edge (1) and the gripping means(2) may be connected by a locking mechanism and / or a region of weakness (18) configured to enable separation of said cutting edge (1) and gripping means before, during, or after use. If the cutting edge (1) and the gripping means (2) are connected by a region of weakness (18), the region of weakness (18) may be configured to be ruptured either manually, including by hand, or automatically upon removal of the tool from a blister pack or other type of packaging and / or the region of weakness (18) may be positioned such that it must be broken before the cutting edge (1) of the cutting means can be accessed or operated.According to any embodiment of the invention, the cutting edge (1) and the gripping means (2) may be connected by a connecting part comprising a region of weakness (18), the connecting part may be shaped to position the cutting edge (1) relative to the gripping means (2) in such a manner that, prior to breaking the region of weakness (18), the gripping means (2) obstructs or covers the cutting edge (1). For example, the connecting part may be U- shaped, in which case the cutting edge (1) extends in the same direction as the gripping means (2) from the connecting part of the punch biopsy tool.According to any embodiment of the invention, the region of weakness (18) may be formed by, or may comprise, a reduced wall thickness , a reduced material thickness, and / or a predefined notch, groove, perforation, bridge, hinge, and / or other frangible link or structural modification configured to facilitate intentional or controlled breakage.According to any embodiment of the invention, the region of weakness (18) may be configured to be broken or ruptured by the application of mechanical stress, such as bending, twisting, pulling, or a combination thereof, thereby allowing controlled separation of the cutting edge (1) from the gripping means (2).According to any embodiment of the invention, the region of weakness (18) or releasable locking means between the cutting edge (1) and the gripping means (2) may be configured to permit mechanical separation of the cutting edge (1) from the gripping means (2), such as by a snap-fit, corresponding threads, bayonet lock, hinge release, frangible bridge, or other mechanical connection adapted to allow intentional or controlled detachment.According to any embodiment of the invention, the cutting edge (1) connected to the handle part (3) for the cutting edge (1) and the gripping means are formed as a single unitary structure prior to separation, e.g. by moulding or printingBrief description of the figuresFigure 1 shows an embodiment of a punch biopsy tool according to the invention.Figures 2A and 2B shows one end of an embodiment of a punch biopsy tool according to the invention comprising a safety cap in respectively a retracted state and a forward state.Figure 3 shows the outer end portion and part of gripping means according to the invention in a view showing a recess of holding a biopsy.Figure 4 shows the outer end portion and part of gripping means according to the invention in a side-view showing the angular of the arms of the gripping means.Figures 5A-5C illustrates angular positions of two opposing arms functioning as gripping means of an embodiment of a biopsy tool.Figures 6A-6B illustrates an embodiment of a biopsy tool comprising a plunger.Figures 7A-7C show a first embodiment of the protruding edges of the outer end portion.Figures 8A-8B show a second embodiment of the protruding edges of the outer end portion.Figures 9A-9B show a third embodiment of the protruding edges of the outer end portion.Figure 10 shows an embodiment of a biopsy tool according to the invention comprising a region of weakness positioned between the gripping means and the handle for the cutting means.Figure 11 shows an embodiment of a biopsy tool according to the invention comprising a region of weakness positioned between the handle for the cutting means and the cutting edge.Figures 12A and 12B shows an embodiment of a biopsy tool according to the invention comprising a U-shaped connecting part connecting the gripping means and the cutting edge.Detailed description of the inventionDefinitionsPrior to discussing the present invention in further details, the following terms and conventions will first be defined :In general - when this expression is used when mentioning a feature relating to the present invention, it must be understood that the feature may be used with all embodiments of the invention, even if the mentioning is made in the detailed part of the document."Outer end" "outer portion" - when using the word outer in "outer end" and "outer portion" then "outer" refers to the part or position furthest away from a central body.Opposing arms - means that two arms are placed opposite each other and may move towards each other along a straight line e.g. from a non-biased or relaxed position to a biased position.Converging arms - means that three or more arms are placed facing each other and may move towards each other e.g. towards a central point, e.g. from a non-biased or relaxed position to a biased position.The present invention will now be described in more detail in the following.In general, a biopsy tool according to the present invention is a punch biopsy tool used to cut and sample a biopsy from cutaneous and / or mucosal surfaces.In general, a biopsy tool according to the invention comprises primary cutting means comprising a cutting edge 1 used to cut an insertion gap 15a in the cutaneous or mucosal surface in a direction of insertion. Normally, the cutting edge 1 comprises a continuous or closed cutting edge 1 e.g. having a round profile, defining a cross-sectional profile or perimeter of a sample 15 having a longitudinal shape such as a cylindrical body. Beside the size and profile shape of the cutting edge 1, the final shape of the sample may depend on the structure of the cutaneous or mucosal surface from where the sample 15 is provided, if the structure from which the sample is taken is a firm cutaneous surface the shape may be approximately cylindrical even after the sample 15 is removed from the remaining tissue, however, if the structure of the cutaneous or mucosal surface, on the other hand, is porous or less cohesive, the sample 15 may not have a well-defined shape and may fall apart and e.g. be difficult to extract.In general, the cutting edge 1 may be part of a punch part 4 made of a single piece of material such as stainless steel or similar material being hard enough to constitute the cutting edge 1, e.g. the punch part 4 may have a continuous or closed cutting edge 1 and a length lpbeing longer than the minimum length I of a desired cutting depth.The punch biopsy tool also comprises gripping means 2, 2a, 2b for catching and holding the sample 15, and optionally the punch biopsy tool comprises means for cutting the sample 15 at the lower end of the sample 15. Means for cutting and thereby releasing a sample 15 may comprise one or more secondary cutting edges 7.In general, the gripping means 2, 2a, 2b comprise an outer end configured to be inserted into the insertion gap 15a cut by the primary cutting means, and an inner end configured to be attached to or constitute a handle or a central part of the punch biopsy tool.In general, the gripping means 2, 2a, 2b may have at least two states, an open state, e.g. a non-biased state and / or a slightly biased state, which is applied when the gripping means 2, 2a, 2b are inserted into an insertion gap 15a, and a closed state, e.g. a biased state or fully biased state, which is applied when the gripping means 2, 2a, 2b are grabbing the sample 15 and then removed from the insertion gap 15a carrying or at least supporting the sample 15.According to an embodiment, the closed state may be obtained as two or more flexible or flexibly mounted arms are forced together as with a pair or tweezers or forceps until the arms meet. Preferably, the arms comprise protruding edges at the lower or outer end, which may protrude or extend in a direction towards a common centre, and above the lower edge i.e.closer to the central body, the distance between the opposing arms may be increased. The lower protruding edges may comprise one, two or more cutting edge(s), also referred to as secondary cutting means, configured to cut the lower end of the sample free from the remaining tissue, if the structure constituting the sample is not porous enough to be loosened just by forcing the lower edges together and then pull. Alternatively, the sample may be held by the gripping means while cut free from the remaining tissue by a separate tool such as a scissor or a scalpel.In general, the outer end portion of the gripping means may comprise or provide a recess or an open space in the closed state. A biopsy or sample may be contained in this recess or open space in the closed state, and the recess / open space may be adapted in size and shape to the extracted sample. Such a recess or open space protects the biopsy or sample from being disintegrated during removal or extraction of the sample. This is an important feature for tissue samples where porosity of the tissue makes it very difficult to extract an intact sample and intact samples are occasionally significant for a pathologist to reach a correct diagnosis.The outer end portion of the gripping means 2, 2a, 2b may comprise one or more supporting parts which upon removing the outer end portion of the gripping means from an insertion gap extends over at least 50%, or at least 60%, or at least 70% of the width of the lower end of the sample to be removed. "Width" is understood to be the size of the lower end of the sample in at least one dimension, if the lower end of the sample is circular the "width" corresponds to the diameter of the lower end of the sample. The width of the sample is determined by the cutting edge. When the supporting parts constitute at least 50% of the width of the sample, the supporting parts facilitates removal of relatively porous tissue samples.The recess / open space may be constituted of longitudinally extending parts e.g. constituted by opposing arms of a tweezers or forceps, in combination with a supporting part e.g. constituted by protruding edges at the outer end of the opposing arms. To create a space the opposing arms are positioned with increasing distance dl (see fig. 7C) to each other at least for the maximum length of a sample. Alternatively, the recess / open space may be constituted of an actual space e.g. shaped like a spoon, having walls on two or three sides combined with a supporting part as illustrated in figs. 3 and 5.In general, if the punch biopsy tool comprises gripping means in form of opposing or converging arms, the arms in a relaxed, non-biased position are positioned in a distance dl to each other at the outer end creating an opening between the arms. In general, the distance dl between the opposing or converging arms in a relaxed state may be adapted in size and shape to the primary cutting edge or punch part constituting a part of the punch biopsy tool. One or each of the outer ends of the outer end portion of each arm may comprise a secondary cutting edge. Alternatively, the outer end of the outer end portion of each arm may comprise protruding surfaces or edges fitting to each other and forming an approximately closed surface when forced toward each other, i.e. in a biased state. The protruding edge or cutting edge prevents the opposing or converging arms from squeezing the sample, above the protruding or cutting edge a space is created for containing the sample. However, the protruding or cutting edge should only protrude max. 2 mm, or max. 1 mm in order not tocreate discomfort to the patient or to damage the tissue around the sample, when the gripping means are pushed into the insertion gap cut around the sample.A punch biopsy tool according to the invention is configured to provide a sample 15 by primary cutting means creating a cut directed approximately perpendicular to the cutaneous or mucosal surface. A cut being approximately perpendicular to the cutaneous or mucosal surface makes it possible to prepare a relatively deep sample, preferably being around 3-10 mm deep, while minimizing the upper / outer surface of the wound which after cutting is accessible to microorganisms and therefore infections.The cutting edge 1 may constitute a flat profile i.e. a profile being approximately either parallel to the cutaneous or mucosal surface upon cutting or inclined relative to the surface upon cutting. Alternatively, the cutting edge 1 may be curved, e.g. the cutting edge 1 may comprise one or more concave and / or convex sections e.g. providing a wavelike profile.When using the primary cutting means for cutting, the cutting edge 1 can either be rotated while being pushed against the cutaneous or mucosal surface during cutting, or the cutting edge 1 can be forced or punched into the surface in a direction perpendicular to the surface without turning the cutting edge 1. If the cutting edge 1 is rotated as well as pushed against the cutaneous or mucosal surface during cutting, the cutting edge 1 has a round profile to reduce damage to the surrounding tissue.One advantage of a punch biopsy tool according to the invention is that the biopsy tool according to the invention may replace two or three traditional tools for preparing a biopsy sample.According to an embodiment, a punch biopsy tool may replace two tools such as a primary cutting means in form of a traditional punch biopsy tool, and a gripping means similar e.g. to a set of tweezers. Such an embodiment may comprise gripping means comprising two or more opposing or converging arms 2a, 2b extending in a longitudinal direction approximately parallel to each other where each arm 2a, 2b has an outer end portion 12 to be inserted into an insertion gap during use, and an inner end 13 fixed to a handle part of the biopsy tool. When the gripping means are used to grab the cutaneous or mucosal sample and pull the sample out of the insertion gap, a scalpel or a scissor may be used to release the sample from the tissue by cutting the lower end of the sample. If the cutaneous or mucosal sample 15 is porous or disjointed it may not be necessary to cut the lower end of the sample 15 as the sample 15 may be released simply by squeezing and pulling.According to an embodiment, the punch biopsy tool may replace three tools such as a primary cutting means, a gripping means such as a set of tweezers and a scalpel, or scissors used to cut the cutaneous or mucosal sample free at the lower end of the sample. Such an embodiment may comprise gripping means comprising two or more opposing arms 2a, 2b extending in a longitudinal direction approximately parallel to each other where each arm 2a, 2b has an outer end portion 12 to be inserted into an insertion gap during use, and an inner end 13 fixed to a handle part of the biopsy tool. Also, the one, two or more opposing or converging arms 2a, 2b may comprise a secondary cutting edge 7 at the outer end portion 12 of the gripping means and when the outer end portion 12 is inserted into the insertion gapdefining the circumference of the sample, the at least one cutting edge 7 may be moved in a direction approximately perpendicular to the direction of insertion of the cutting edge 1.According to any embodiment of the present invention, the primary cutting means and the gripping means are constituted of different parts and are positioned at different positions of a single biopsy tool. I.e., the primary cutting means and the gripping means may be used independently of each other in a sequential process. Optionally, the primary cutting means and the gripping means may extend into different directions such as opposite directions from a common central part or common body part of the biopsy tool. The common central part or body part may constitute a handle 3 to be used when handling the primary cutting means of the biopsy tool.In general, the two or more opposing or converging arms 2a, 2b may be either flexibly mounted to the common central part or common body part of the biopsy tool, or they may be rigidly mounted but be constituted of a flexible material, in order to move either one or more of the outer end portions 12 of the opposing or converging arms 2a, 2b in a direction towards each other which direction may also be described as horizontal or perpendicular to the direction of insertion.An advantage of positioning the parts constituting respectively the primary cutting means and the gripping means separately, is that it is possible to optimize the functionality of each of the means while also adapting them to each other in size and shape. When the two means are adapted to each other, the primary cutting means may cut in a direction, a prescribed size and a depth which is optimal for preparing a specific cutaneous or mucosal sample while the gripping means may be optimized and adapted to slide into the insertion gap prepared by the specific primary cutting means of the same biopsy tool and grab the sample without crushing or otherwise destroying the sample.In general, a punch biopsy tool according to the invention may be constructed as a reusable tool which may be used multiple times and is adapted to be subjected to a sterilization process e.g. at high temperature, by steam, by gas or another known sterilization process.A reusable embodiment of a biopsy tool according to the invention may be prepared from a more expensive and durable material such as metal e.g. stainless steel, and the cutting edge 1 may constitute a build-in part of the structure.Alternatively, a biopsy tool according to the invention may in general be constructed as a disposable tool or partly disposable tool, where a "disposable tool" is disposed of in its entirety after use, and a "partly disposable tool" comprises at least one part which may be used multiple times and may be adapted to be removed and to be sterilized.A disposable or partly disposable embodiment of a biopsy tool according to the invention may be prepared from one, two or more parts, and one part may be prepared by moulding or printing of a polymeric material such as PP, ABS, PA, PET or similar. This part of polymeric material may be combined with a piece of a hard material such as a metal e.g. stainless steel, which is suitable for creating a sharp cutting edge constituting the primary cutting means comprising the cutting edge 1.In general, the primary cutting means comprising the cutting edge 1 may comprise a pipe- or tube-like body, e.g. made of metal such as stainless steel, extending in a longitudinal direction and having a constant profile in a cross-sectional direction. The cutting edge 1 is positioned at a first end or an outer end of the tube-like body whereas the opposite end of the tube-like body is fixed to a handle part 3 of the punch biopsy tool. The cutting edge 1 has the same profile as the constant cross-sectional profile of the tube-like body. The constant cross- sectional profile is traditionally round but may have any shape such as polygonal, or oval, as the shape of the cross-sectional profile may be adapted to a specific purpose.In general, the cutting means may be adapted to create an insertion gap 15a having a length - or depth - of maximum 20 mm, or maximum 15 mm, or maximum 10 mm, and of minimum 2 mm, or minimum 3 mm, or minimum 5 mm. Maximum and minimum length / depth of the cut providing the insertion gap 15a normally correspond to the area of the cross-sectional profile of the cutting edge 1 as the area and the length / depth together define a sample 15 of a desired volume.In general, a punch biopsy tool according to the invention may be produced in a series of sizes and / or cross-sectional profiles combining corresponding length / depth of the cutting with area of the cross-sectional profile making it possible for a healthcare professional such as a doctor or nurse or veterinarian to choose a punch biopsy tool suitable for a given task.In general, a series of punch biopsy tools may have different sizes of primary cutting means 1 where the cutting edge of each tool has a cross-section or diameter of between 1 - 14 mm, and a depth - or length of tube-like body to be inserted - of between 3 and 10 mm. A series therefore may comprise a number of punch biopsy tools each comprising a primary cutting means 1 of a fixed size, when an operator wants to take a biopsy or sample of a given size, the operator chooses a punch biopsy tool having a primary cutting means 1 of the desired size. According to a preferred embodiment, the primary cutting means 1 and the gripping means 2 of each punch biopsy tool belonging to a series are adapted to each other and the gripping means 2 may comprise two or more opposing or converging arms extending in a direction parallel to each other or at sections inclined relative to each other in such a way that the outer end portions of the gripping means 2 are easily inserted into the insertion gap 15a provided by the cutting edge 1 of the same biopsy tool, while a portion of the outer end portion 12 of the gripping means also grab gently around the cutaneous or mucosal sample 15.When the gripping means comprise two or more opposing or converging arms each comprising an outer end portion 12 to be inserted into the insertion gap 15a, then the outer end portion 12 of one or more opposing or converging arms may comprise a cutting edge 7. Such a cutting edge 7 may point or cut in a horizontal direction which horizontal direction is essentially perpendicular to the direction of insertion. Each cutting edge 7 may comprise a straight or triangular or rounded cutting edge 7 depending on whether one, two, three or more opposing or converging arms 2a, 2b comprise(s) a cutting edge 7, and whether this or these one, two, three or more cutting edge(s) 7 meet one or more cutting edge(s) 7 at the outer end portion 12 when the opposing arms are squeezed together.According to a preferred embodiment, the two or more opposing or converging gripping means are each adapted in size and in shape to fit into the insertion gab 15a made by the corresponding primary cutting means of the same punch biopsy tool. If the insertion gap 15a is round, and the gripping means comprise two opposing arms 2a, 2b, then the shape in the width-dimension of the cutting edge 7 of one or each arm of the gripping means may be straight and the width of the cutting edge 7 may be 40-90%, or 50-80%, or 60-80%, or around 70% of the diameter of the cutting edge 1 corresponding to the diameter of the insertion gap. The outer surface of the outer end portion 12 of each arm of the gripping means may be rounded in cross-sectional direction to fit into the circular form of the insertion gap when in use, the cross-sectional direction being perpendicular to the insertion direction in a use-situation.In general, the outer end portion 12 of one or more of two or more opposing or converging arms of the gripping means, may comprise a spoon-like recess 8 which prevents squeezing of the sample 15. It also has a 'spoon' effect in the case of porose tissue where the tissue otherwise easily falls apart, when gripping and pulling it.The "outer end portion" 12 of each arm of the gripping means 2 may constitute 10-30 % of the free length of an opposing or converging arm 2a, 2b measured from the outer end e.g. defined by the protruding and / or cutting edge 7. The length of the outer end portion 12 may be adapted to the length or depth of the insertion gap 15a surrounding the sample 15, e.g. around 10 mm, of one or of each arm 2a, 2b.In general, a punch biopsy tool according to the invention may comprise a plunger 10 comprising a front surface 11, which plunger 10 is adapted to pass from a retracted position inside the punch part 4 to a forward position. At the retracted position, the front surface 11 of the plunger 10 defines a closed end or partly closed end of the primary cutting means and in the forwards position the front surface 11 of the plunger 10 is at level with the cutting edge 1 or has passed beyond the cutting edge 1. During use of the biopsy tool, the plunger 10 may push a cut sample 15 out of a tube-like body which - completely or partly - constitutes the primary cutting means. The plunger 10 may after use provide a protection against accidentally getting into contact with the sharp cutting edge 1, especially if the front surface 11 of the plunger extends beyond the cutting edge 1 in the forward position.Figure 1 shows an embodiment of a biopsy tool according to the invention. The shown embodiment is a disposable tool which may be moulded or printed of a polymer material. This embodiment a comprises a cutting edge 1 being part of a punch part 4, the punch part 4 is attached to a handle part 3 making it possible to manually forcing the cutting edge 1 into the cutaneous or mucosal to obtain a sample. According to this embodiment, the handle part 3 constitutes a central body of the tool and the handle part 3 may also comprises printed information about the tool such as size of the cutting edge 1 e.g. 05mm which makes it easier for the user to identify the size after the tool is taken out of the sterile packing. Normally, the punch part 4 is a hollow tube-like part where the cutting edge 1 constitutes the front surface or front profile of the punch part 4. When the punch part 4 is moved forward in direction of the cutting edge 1, the cutting edge 1 will cut a round or otherwise profiled insertion gap 15a defining a sample 15 having a free upper end and a lower end which is still attached to the body from where the sample 15 is to be removed. The shown embodiment belongs to a seriesof tool and as printed on the handle 3 of the embodiment, the specific embodiment of the tool has a punch part 4 comprising primary cutting means 1 having a diameter of 5 mm.The shown embodiment comprises a safety cap 6. The safety cap 6 and the part of the primary cutting means to which the punch part 4 is attached comprise corresponding locking means 9a, 9b in form of an opening and contact surface of the safety cap 6 and a protruding part 9b of the handle / punch part 3, 4. The safety cap 6 comprises a push surface 6a which makes it possible for a user to push the safety cap 6 to a forward and optionally locked position where the safety cap 6 covers the cutting edge 1.The shown embodiment also comprises gripping means 2 constituted of two longitudinally extending arms 2a and 2b having an inner end 13 being mounted to the handle part 3 and an opposite outer end portion 12 where the two arms 2a, 2b in a relaxed state is positioned at a distance to each other. The flexibility of the two arms 2a, 2b or a flexible mounting of at the inner end 13 allows the two outer ends of the arms 2a, 2b to meet when pushed together. One or each of the two arms 2a, 2b may both comprises a cutting edge 7 at the outer end making it possible to cut a sample free at the lower end before pulling the sample up and out of the surrounding tissue.Each of the arms 2a, 2b may comprise a handle part 5 providing a rough or non-slippery surface where the user may obtain a good and controllable grip even with wet hands or hands covered by latex or rubber gloves.In general, and as shown in fig. 1, the distance dO between the inner surfaces 17 of the arms 2a, 2b as well as the distance between the outer surfaces 16 of the arms 2a, 2b may increase from the protruding and / or cutting edge 7, dO,posl, to a central point of the handle part 5, d0,pos2. The increasing distance dO from positionl to position2 of the inner surfaces prevents a sample 15 from being squeezed and the increasing distance of the outer surfaces provides the operator with an ergonomic grip of the gripping means when handling the punch biopsy tool.Also, the inner surface 17 of the outer portion 12 of the arms may be positioned at an angle a relative to the insertion direction used to make an insertion gap (15a). Relative to the insertion direction, i.e. the insertion direction defining 0 degrees, the angle a may be larger or equal to 0 degrees and normally smaller than 45 degrees (0° < a < 45°), e.g. 5° < a < 30°.An angle a above 0 degrees, e.g. above 5 degrees, provides an increasing distance dO and therefore prevent squeezing of a sample 15 during holding and removal of the sample 15.Figures 2A and 2B shows one end of an embodiment of a punch biopsy tool, a punching or cutting end, comprising a safety cap in respectively a retracted state and a forward state.Fig. 2A illustrates the retracted state of the safety cap 6. In general, a safety cap 6 may be locked in the retracted state by locking means 9 which locking means 9 may comprise corresponding surfaces 9a, 9b which prevent movement of the safety cap 6 in one direction. According to the shown embodiment, the safety cap 6 comprises a tube-shaped member with a longitudinal side opening 14, the locking means 9 comprises in the shown embodiment a surface 9a of the side-opening 14 of the safety cap and oa protruding surface 9b protruding from a surface of the primary cutting means. An inclined surface of the protruding partcomprising the surface 9b (facing left in figs. 2A and 2B) allows for a part of the tube-shaped safety cap 6 to slide over the protruding part comprising the surface 9b when subjected to force applied to the push surface 6a in the direction indicated with the arrow below the embodiment of fig. 2A. The surface 9a of the safety cap 6 facing opposite the direction of the arrow and defining an end of a side-opening 14 in the safety cap 6 provide the locking means 9 of the safety cap 6. In the forward position of the safety cap 6 shown in fig. 2B, the surface 9a of the opening of the safety cap 6 faces the surface 9b of the protruding part of the primary cutting means. As the surface 9b of the protruding part is steep, the safety cap 6 cannot pass back to the retracted position and the safety cap 6 is locked in the forward position. The shown locking means for the safety cap are very simple and there may be other ways for a skilled person to construct such locking means with corresponding surfaces.Figure 3 shows an enlargement of an outer end portion 12 of gripping means comprising two opposing arms 2a, 2b according to the invention in a view showing a recess 8 for receiving a sample during use. This view of the gripping means 2a, 2b illustrates how a recess 8 may be provided in each arm 2a, 2b of the gripping means 2. An inclining outer surface (i.e. the lower surface closest to the protruding edge 7 as illustrated in fig. 3) of each arm 2a, 2b makes it possible to insert the gripping means into the insertion gap made by the punch part 4 of the primary cutting means positioned at a different position. In general, the shape and size of the gripping means 2 are adapted to the punching part 4 in such a way that the outer end portion 12 of the gripping means fits into the cut defined by the size of the cutting edge 1.Figure 4 shows a side-view of an embodiment according to the invention of gripping means 2 comprising two opposing arms 2a, 2b each provided with an outer end portion 12. The view shows how the outer portions 12 of each of the opposing arms 2a, 2b in a relaxed position are positioned in a distance dO to each other at the outer end. In general, the distance dO between two opposing arms in a relaxed state may be adapted to primary cutting edge 1 or punch part 4 which is also constituting a part of a punch biopsy tool according to the invention. In the shown embodiment, the outer end of each arm 2a, 2b comprises a protruding edge and / or a cutting edge 7. Also, the outer portion 12 of the arms 2a, 2b are positioned at an angle a relative to the insertion direction or the longitudinal direction of the device which longitudinal direction is illustrated by a dotted line. The angle a relative to the insertion direction, or the angle 2 x a defining the angle between the inner surfaces 17 of the outer portions 12 of the arms 2a, 2b, may support pushing tissue aside which surrounds a cut-out sample 15 when the gripping means 2 are inserted into a circular or otherwise shaped insertion gap 15a made by a punch part 4. Pushing the surrounding tissue aside facilitates releasing of the sample 15 when forcing the arms 2a, 2b together and e.g. cutting the sample 15 free either with a cutting edge 7 of the gripping means 2 or with a separate cutting tool at the lowest position of the sample 15. This is done without squeezing the volume of the sample 15, or at least with less squeezing of the volume of the sample 15 than done with traditional gripping means, and this reduces the risk of damaging the tissue sample 15.Figures 5A-5D illustrate a side-view of a cutaneous or mucosal sample 15 which in a cross- sectional or horizontal direction is defined by an insertion gap 15a. The insertion gap 15a is prepared or formed by cutting in the insertion direction with the primary cutting means which are positioned and dimensioned relative to the gripping means 2. The insertion direction maybe perpendicular to the cutaneous or mucosal surface, or the insertion direction may be angled relative to the cutaneous or mucosal surface, the choice of insertion direction is based on the knowledge of the person taking the sample.Fig. 5A illustrates what happens when inserting the gripping means 2a, 2b into the insertion gap 15a. When the gripping means 2a, 2b are fully inserted the sample may be released by forcing the opposing arms 2a, 2b of the gripping means together thereby gripping the sample 15.In general, when there are only two opposing arms 2a, 2b, the arms preferably mirror each other.In general, when there are only two opposing arms 2a, 2b, each arms 2a, 2b has an inner surface 17 facing the oppositely positioned arm, and each arms 2a, 2b has an outer surface 16 facing away from the oppositely positioned arm. According to a preferred embodiment, the inner surface 17 of the outer end portion 12 of each arm 2a, 2b is inclined relative to the insertion direction at an angle a where 5° < a < 15°, or 8° < a < 11°. According to a preferred embodiment, the outer surface 16 of the outer end portion of each arm 2a, 2b is inclined relative to the insertion direction at an angle of at least the same size as the angle a, preferably the inclination angle of the outer surface 16 increases at the outer portion 12, normally close to the outer end, from a to at least 45°, or at least 60°, or at least 80°, and may preferably meet the inner surface 17 at or near a protruding edge 7.Fig. 5A illustrates how the inclination of the outer surface 16 may be changed in steps, and at a first step - furthest away from the outer end of the arm and closest to the centre part of the tool - the outer surface 16 is parallel to the inner surface 17 and has an angle a relative to the insertion direction in a relaxed state. In a next step the outer surface 16 is inclined relative to the inner surface 17 in a larger angle p relative to the insertion direction in a relaxed state. In a third step, the outer surface 16 is rounded towards or otherwise approaching the inner surface 17 defining the outer end of the arm 2a, 2b.In general, angle a < angle < the angle of the outer surface closest to the outer end is further increased and may approach 90°. In the embodiment shown in fig. 5A, the angle a is 10°, the angle p is 35°, and the angle of the last step is 65°.When one or each arm 2a, 2b comprises a straight or slightly curved protruding and / or cutting edge 7, it has shown to be advantageous to provide one or each arm 2a, 2b with an inclined outer surface 16 in the longitudinal direction or the insertion direction which provides a slightly increasing outer diameter or other cross-sectional profile near the upper or outer end of the sample as the gripping means 2 are inserted into the insertion gap 15a.According to the embodiment shown in fig. 5A the gripping means 2 comprising the two opposing arms 2a, 2b are in a relaxed state and have been inserted into the outer or upper part of the insertion gap 15a. The cutaneous or mucosal surface surrounding the insertion gap 15a is pushed away from the insertion gap 15a forming a bulge which is in contact with the outer surface 16 of the arms 2a, 2b.When having reached as low as desired into the insertion gap 15a to obtain a desired volume of the sample 15, the gripping means 2a, 2b are pushed or pressed together and the straightprotruding and / or cutting edges 7 of the gripping means then either squeeze or cut to grip or release the sample 15 at the lower end whereafter the sample 15 is removed while the joined gripping means 2a, 2b support the lower end of the sample 15. The recesses 8 in both the opposing arms 2a, 2b protect the sample 15 during removal which is particularly advantageous if the sample comprises soft or loose tissue to avoid the sample 15 from being squeezed or otherwise damaged during the removal process.Figures 5B and 5C illustrate respectively a side view and an end view, of dimensions of the outer end portion 12 of an embodiment of the gripping means 2 comprising two opposing arms relative to a sample 15. The figs also illustrate how the gripping means 2 are positioned during gripping of the sample 15.Fig. 5B shows a side view of a sample 15 and how the gripping means 2 comprising two arms 2a, 2b having outer portions 12 are dimensioned relative to the sample 15. Normally, a sample 15 has a diameter or cross-section dimension d between 1 - 10 mm, and a length or depth I of between 3 - 10 mm.The outer end portions 12 of the arms 2a, 2b correspond in cross-sectional size and shape to the insertion gap 15a made by the cutting edge 1 of the punch part of the biopsy tool according to the invention.In a cross-sectional view, the shape of the arms 2a, 2b are adapted to the shape of the insertion gap 15a made by the cutting edge 1. In the shown example of fig. 5B and 5C, the sample 15 has a circular cross section, the insertion gap 15a is therefore round and in order for the arms 2a, 2b to fit into the insertion gap 15, the outer surface 16 of each arm in a cross-sectional section is shaped as part of a circular arch as seen in fig. 5C. In the longitudinal direction, the profile of the outer surface 16 of each arm is straight and in three sections which sections are joined in continuous curved junction or in sharp discontinuous junctions as seen in fig. 5B.In general, the outer surface 16 of each arm 2a, 2b may be curved in a cross-sectional or horizontal direction and corresponding to the shape and angle as the insertion gap 15a. The cross-sectional or horizontal direction is perpendicular to the insertion direction.Also, if the sample 15 has a round cross-section, the width of a straight protruding and / or cutting edge 7 of an arm 2a, 2b may constitute less than 100% of the maximum cross- sectional width such as less than 100% of the diameter of the sample 15. Preferably less than 90%, or less than 80% of the maximum cross-sectional width of the sample, and / or the width of the cutting edge 7 of each arm may constitute at least 40% of the maximum diameter, or at least 50% of the maximum of the diameter of the sample 15.Example 1The desired sample should have a diameter of 3 mm.The punch biopsy tool used for providing the sample comprises a punch part 4 comprising cutting edge 1 constituted of a round / cylindric metal unit having a diameter of 3 mm and a free length of 8 mm.The gripping means 2 comprises two opposing arms 2a, 2b each comprising a straight secondary cutting edge 7. The length / width of each cutting edge 7 constitutes 70% of 3 mm i.e. 2.1 mm.In a cross-sectional view, the outer surface 16 of the outer portion 12 of each arm 2a, 2b is curved as a circular arch reaching from one end of the straight protruding edge 7 to the other end of the protruding edge 7.In a longitudinal view i.e. in a view parallel to the insertion direction, the outer surface 16 of the outer portion of each arm 2a, 2b, is step-wise approaching the angle of the inner surface 17. In a first section the angle a is 9°, in the second section the angle p is 35°, and in the third section the angle y is 65°, in the last section closest to the cutting edge 7, the angle is 80°. In a relaxed state, the distance 6 between the arms 2a, 2b is 2 mm larger than the diameter of the sample 15, i.e. 5 mm.Example 2The desired skin sample should have a diameter of 8 mm.The skin punch biopsy tool used for providing the sample comprises a punch part 4 comprising cutting edge 1 constituted of a round / cylindric metal unit having a diameter of 8 mm and a free length of 8 mm.The gripping means 2 comprises two opposing arms 2a, 2b each comprising a straight secondary cutting edge 7. The length / width of each cutting edge 7 constitutes 70% of 8 mm i.e. 5.6 mm.In a cross-sectional view, the outer surface 16 of the outer portion 12 of each arm 2a, 2b is curved as a circular arch reaching from one end of the straight protruding edge 7 to the other end of the protruding edge 7.In a longitudinal view i.e. in a view parallel to the insertion direction, the outer surface 16 of the outer portion of each arm 2a, 2b, is step-wise approaching the angle of the inner surface 17. In a first section the angle a is 9°, in the second section the angle is 35°, and in the third section the angle y is 65°, in the last section closest to the cutting edge 7, the angle is 80°. In a relaxed state, the distance 6 between the arms 2a, 2b is 2.2 mm larger than the diameter of the sample 15, i.e. 10.2 mm."Free length" means that the cutting edge 1 may be inserted into a depth of the skin defined by the free length.Figure 6A and 6B show an embodiment of a primary cutting means of a biopsy tool according to the invention comprising both a safety cap 6 and a plunger 10 comprising a front surface 11.Fig. 6A shows the safety cap 6 and the plunger 10 in a retracted position whereas fig. 6B shows the safety cap 6 and the plunger in a forward position. According to this embodiment, the safety cap 6 and the plunger 10 are moved from the retracted to the forward position simultaneously as they are mechanically connected, however, this is not a requirement for the invention as such, i.e. the safety cap 6 and the plunger 10 may move independently of each other.If the safety cap 6 and the plunger 10 are not mechanically connected, then the plunger 10 comprises activation means which may be activated and push the plunger to the forward position, if the sample is stuck inside the punch part 4 after the sample 15 has been released from the cutaneous or mucosal surface.The outer end portion 12 of a punch biopsy tool according to the invention may be adapted in shape and size to a specific purpose. Figures 7, 8 and 9 illustrate three different shapes of outer end portions 12. When any of these embodiments are in use, the protruding edges 7 are forced through or into the insertion gap 15a created by the primary cutting edge 1 to the lowest end of the sample 15.Figures 7A, 7B and 7C show an embodiment with two opposing arms where each arm 2a, 2b has an outer end portion 12 comprising an outer protruding edge 7. The outer protruding edge 7 of each arm 2a, 2b is straight and angled at angle 6 relative to an axis A defining the extension of the arms 2a, 2b. The angle 6 between the axis A and the lower surface of the protruding edge 7 is around 30 degrees in the shown embodiment, normally the angle 6 is between 20-50 degrees. The angle 6 illustrates the angle in which the arms 2a, 2b are held when gripping and removing the sample 15. Having an angle 6 below 90 degrees such as around 45 degrees makes the tool easier to control and more ergonomic to the operator.Figures 8A and 8B show an embodiment with two opposing arms where each arm 2a, 2b has an outer end portion 12 comprising an outer protruding edge 7. The lowest or outer most surface 7a of the protruding edge 7 of this embodiment is rounded, the upper surface 7b may be either straight or rounded.Figures 9A and 9B show an embodiment with two opposing arms where each arm 2a, 2b has an outer end portion 12 comprising an outer protruding edge 7. According to this embodiment the outer end portion 12 is angled relative to the handle part 5 of each arm 2a, 2b, and the protruding edge 7 of each arm is straight. The angle p between the axis A of the arms comprising the handle part 5, and the axis B of the outer end portion 12 is around 120 degrees in the shown embodiment, normally the angle is between 110-140 degrees. The angle p illustrates the angle which the arms 2a, 2b are held when grabbing and removing the sample 15.For all three embodiments, the protruding edges 7 of the two arms 2a, 2b provides a space or gap above the protruding edges 7, where "above" is understood to be between the protruding edges 7 and the handle parts 5, which space prevents the sample 15 from being squeezed during removal.A punch biopsy tool according to the invention may comprise an integrated region of material weakness or mechanical weakness or a releasable locking means configured to allow separation of the tools into two or more parts before, during, or after use.In one embodiment, the punch biopsy tool comprises a cutting edge and a gripping means that are integrally formed and connected by the region of weakness. The region of weakness is designed such that it can be ruptured manually, for example by hand, or automatically, for example when the device is removed from a blister pack or other type of packaging or if pressed against an object.By providing such an integrated mechanical or material weakness, the cutting element and the gripping means may be separated and used individually. Consequently, there is no need for a protective safety cap, as the cutting element can be used and subsequently discarded prior to the use of the gripping means for handling or retrieving the tissue sample.In another embodiment, the region of weakness is strategically located such that it must be broken before the cutting edge can be accessed or used. In this configuration, the gripping means obstructs or overlaps the cutting edge and must therefore be detached or broken off in order to expose the cutting edge for operation. The region of weakness is designed such that it can be ruptured manually, for example by hand, or automatically, for example when the device is removed from a blister pack or other type of packaging or if pressed against an object.Fig. 10 illustrates a first embodiment of a punch biopsy tool with an integrated region of weakness 18. According to this embodiment the region of weakness 18 is positioned between the handle part 3 for the cutting means and the gripping means 2. The region of weakness 18 comprises a mechanical weakness shown as a position of a connecting part between the inner end 13 of the arms and the handle part 3 having a reduced cross-section.Fig. 11 illustrates a second embodiment of a punch biopsy tool with an integrated region of weakness 18. According to this embodiment, the region of weakness 18 is positioned between the handle part for the cutting means and the cutting means 4,1. Also, according to this embodiment the region of weakness 18 comprises a mechanical weakness shown as a position of a connecting part between the handle part 3 and the cutting means 4,1 having a reduced cross-section.Fig. 12A and 12B show respectively a top view and a side view of a third embodiment of a punch biopsy tool with an integrated region of weakness 18, the embodiment is U-shaped where the cutting means extends as one leg of the U and the gripping means as the second leg of the U. According to this embodiment, the region of weakness 18 is positioned between the handle part 3 for the cutting means and the gripping means 2. According to this embodiment, the region of weakness comprises a connecting part of an easily breakable material. The breakable material is shaped with a 90 degrees angle which allows the user to grab respectively the cutting means and the gripping means 2 and twist them in opposite directions.Alternatively, the gripping means 2 and cutting means comprising the cutting edge 1 may be separated before, during or after use of the cutting means by a locking mechanism which may be rotated or twisted or clicked to separate the cutting means from the gripping means. The locking mechanism has two states, a locked state where the cutting means comprising the cutting edge and the gripping means are locked to each other and an unlocked state where the cutting means comprising the cutting edge and the gripping means are disconnected and separated from each other.Separation of the cutting edge 1 from the gripping means 2 enables the cutting edge 1 to be used and discarded prior to using the gripping means, thereby eliminating the risk of cuts during use of the gripping means 2 and thereby also eliminating the need for a protective safety cap 6.

Claims

Claims1. A punch biopsy tool for providing a skin or mucous membrane or tissue sample (15) comprising a cutting edge (1) and gripping means (2, 2a, 2b) for gripping a biopsy sample, characterized in that the cutting edge (1) is positioned at a first end of the punch biopsy tool, while the gripping means (2, 2a, 2b) are positioned at a second end of the punch biopsy tool, both the cutting edge (1) and the gripping means (2, 2a, 2b) are secured to a central body.

2. A punch biopsy tool according to claim 1, wherein the cutting edge (1) positioned at the first end of the punch biopsy tool, and gripping means positioned at the second end of the punch biopsy tool are positioned at opposite ends i.e are positioned opposite relative to each other.

3. A punch biopsy tool according to claim 1 or 2, wherein the gripping means (2, 2a, 2b) comprises two, three or more flexible or flexibly mounted arms (2a, 2b) which arms (2a, 2b) are configured to move toward each other until contact between the two or more arms is reached, each arm comprises an inner surface (17) and an outer surface (16).

4. A punch biopsy tool according to claim 3, wherein an outer end of an outer portion (12) of each arm (2a, 2b) comprises a protruding edge (7) and the protruding edge (7) is configured to contact an opposite or converging arm when the arms (2a, 2b) are forced towards each other thereby providing a support for the sample (15) during gripping and / or removal.

5. A punch biopsy tool according to claim 4, wherein at least one protruding edge(s) (7) comprises a cutting edge or cutting means.

6. A punch biopsy tool according to claim 3, 4, or 5, wherein the inner surface (17) of the outer portion (12) of each arm or at least one arm (2a, 2b) is positioned at an angle a relative to the insertion direction used to make an insertion gap (15a), if the insertion direction is 0 degrees then the angle a is larger or equal to 0 degrees and smaller than 45 degrees (0° < a < 45°), normally 5° < a < 30°.

7. A punch biopsy tool according to claim 4 or 5, wherein the width of the protruding edge (7) is smaller than the maximum cross-section e.g. the diameter, of the cutting edge (1).

8. A punch biopsy tool according to claim 4, 5, 6 or 7, wherein the protruding edges (7) are straight and the minimum length of the protruding edge (7) is at least 10%, or at least 20%, or at least 30% or at least 40%, or at least 50% or at least 60% or at least 65% or is around90% of the maximum cross-sectional dimension of the sample (15), and / or is smaller than80% of the maximum cross-sectional dimension of the sample (15), and / or is smaller than75% of the maximum cross-sectional dimension of the sample (15).

9. A punch biopsy tool according to any of the claims 3-8, wherein the outer end portion (12) of one or of each arm (2a, 2b) comprises a recess or depression (8) at the inner surface (17) wherein the recess or depression (8) has walls connected either by a continuous curved junction (rounded corners) or by a discontinuous junction forming distinct edges (sharp angled corners).

10. A punch biopsy tool according to any of the claims 3-8, wherein the outer end portion (12) of one or of each arm (2a, 2b) comprises a recess or opening along the inner surface (17) which recess or opening is provided as a distance (dO) between the longitudinally extending arms increases from the outermost protruding edge (7) creating a space between the opposing or converging arms.

11. A punch biopsy tool according to any of the claims 3-10, wherein the biopsy tool comprises two opposing arms (2a, 2b) and the two opposing arms (2a, 2b) of the gripping means (2) mirror each other and comprise an inclining outer surface (16) and an inclining inner surface (17) wherein the surfaces (16, 17) are inclined relative to the longitudinal direction defining an insertion direction.

12. A punch biopsy tool according to any previous claim, wherein an outer end portion (12) of the gripping means (2, 2a, 2b) and the protruding edge (7) of the gripping means are adapted in size and / or perimeter to an insertion gap (15a) formed by the cutting edge (1) of the same biopsy tool, and surrounding the sample (15) such that outer end portion (12) of the gripping means fit around the sample (15) when inserted into the insertion gap (15a).

13. A punch biopsy tool according to any previous claim, wherein the punch biopsy tool comprises a punch part (4) comprising the cutting edge (1) and the punch part (4) comprises a longitudinally extending tube-like body having a round, ellipsoid or polyangular profile forming a round, ellipsoid or polyangular cutting edge (1) positioned at an outer end of the punch part (4).

14. A punch biopsy tool according to any previous claim, wherein the biopsy tool comprises a safety cap (6) which may be positioned in at least two positions, a first position where the safety cap (6) is at a retracted position relative to the cutting edge (1) where the safety cap (6) does not cover the cutting edge (1), and a second position where the safety cap (6) is at aforward position relative to the cutting edge (1) covering the cutting edge (1) and preventing contact with the cutting edge (1).

15. A punch biopsy tool according to any previous claim, wherein the biopsy tool comprises a handle part (3) configured to be held by a user when moving the biopsy tool in an insertion direction cutting a profile and the length of a sample (15).

16. A punch biopsy tool according to any previous claim, wherein the biopsy tool comprises a plunger (10) comprising a front surface (11) facing forward in an insertion direction, which plunger (10) is configured to be in at least two positions, a first position where the plunger (10) is at a retracted position relative to the cutting edge (1) allowing for cutting with the cutting edge (1), and a second position where the plunger (10) is at a forward position where the front surface (11) of the plunger extends to or beyond cutting edge (1).

17. A punch biopsy tool according to any previous claim, wherein the biopsy tool comprises both a safety cap (6) and a plunger (10) which safety cap (6) and plunger (10) may be mechanically connected and move together with same velocity and in same direction.

18. A punch biopsy tool according to any previous claim, wherein the biopsy tool is either disposable or partly disposable or reusable.

19. A punch biopsy tool according to any previous claim, wherein a handle part (3) for the cutting means, the gripping means (2) and an extending part configured to hold or mount a punch part (4) are manufactured in one piece by moulding such as injection moulding, or compression moulding, or blow moulding, or by thermoforming, or rotational moulding or by 3D-printing, CNC Machining or Extrusion and the punch part (4) comprising the cutting edge (1) is during manufacturing fixed to the extending part.

20. A punch biopsy tool according to any previous claim, wherein the cutting edge (1) and the gripping means (2) are connected by a locking mechanism and / or a region of weakness (18) configured to enable separation of said cutting edge (1) and gripping means before, during, or after use.

21. A punch biopsy tool according to claim 20, wherein when the cutting edge (1) and the gripping means (2) are connected by a region of weakness (18), the region of weakness (18) is configured to be ruptured manually, including by hand, or automatically upon removal of the tool from a blister pack or other type of packaging.

22. A punch biopsy tool according to any of claims 20 and 21, wherein when the cutting edge(1) and the gripping means (2) are connected by a region of weakness (18), the region of weakness (18) is positioned such that it must be broken before the cutting edge (1) of the cutting means can be accessed or operated.

23. A punch biopsy tool according to any one of claims 20-22, wherein the cutting edge (1) and the gripping means (2) are connected by a connecting part comprising a region of weakness (18), the connecting part being shaped to position the cutting edge (1) in such a manner relative to the gripping means (2) that, prior to breaking the region of weakness (18), the gripping means (2) obstructs or covers the cutting edge (1).(for example, wherein the cutting edge (1) extends in the same direction as the gripping means (2) from a central part of the punch biopsy tool.)24. A punch biopsy tool according to any one of claims 20-23, wherein the region of weakness (18) is formed by, or comprises, a reduced wall thickness , a reduced material thickness, and / or a predefined notch, groove, perforation, bridge, hinge, and / or other frangible link or structural modification configured to facilitate intentional or controlled breakage.

25. A punch biopsy tool according to any one of claims 20 to 24, wherein the region of weakness (18) is configured to be broken or ruptured by the application of mechanical stress, such as bending, twisting, pulling, or a combination thereof, thereby allowing controlled separation of the cutting edge (1) from the gripping means (2).

26. A punch biopsy tool according to any one of claims 20 to 25, wherein the region of weakness (18) or a locking means between the cutting edge (1) and the gripping means (2) is configured to permit mechanical separation of the cutting edge (1) from the gripping means(2), such as by a snap-fit, bayonet lock, hinge release, frangible bridge, or other mechanical connection adapted to allow intentional or controlled detachment.

27. A punch biopsy tool according to any of claims 20-26, wherein the cutting edge (1) connected to the handle part (3) for the cutting edge (1) and the gripping means are formed as a single unitary structure prior to separation.

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