Cutting device for shaving skin samples and for excising skin lesions or abnormalities

Abstract

A cutting device for shaving skin samples and for excising skin lesions or abnormalities is provided, the cutting device including: an elongated cutting blade having spaced-apart first and second longitudinal edges, the first longitudinal edge being sharpened along at least a portion thereof; and, a body including a first grip, a second grip, and a flexible blade support affixed between the first and second grips. The cutting blade is supported by the body to extend along the blade support with at least a majority of the first longitudinal edge being proud of the blade support in a direction towards, or beyond, the leading edge of the body. The first grip includes an elongated first grip body disposed transversely to the blade support. The first grip further includes a first engageable grip portion protruding from the first grip body. Advantageously, the subject invention provides a cutting device with an improved grip surface.

Description

CUTTING DEVICE FOR SHAVING SKIN SAMPLES AND FOR EXCISING SKIN LESIONS OR ABNORMALITIESField of the Invention

[0001] The subject invention relates to medical cutting devices, particularly for use in shaving skin samples or excising skin lesions or other abnormalities.Background of the Invention

[0002] Medical cutting devices are known in the prior art for shaving skin samples and for excising skin lesions or other abnormalities. A well-known cutting device is sold under the brand DERMABLADE by AccuTec, Inc. of Verona, Virginia. This cutting device includes an elongated cutting blade supported by a body which includes spaced-apart grips connected by a blade support. For use, the device is engaged by a hand (right or left) of a medical practitioner, with the grips being urged inwardly causing the blade to flex into a U-shape. The low point of the flexed blade (the nadir) is pressed against a target site to shave a skin sample or to excise a skin lesion or abnormality. Although well received, current cutting devices may suffer drawbacks with instability during cutting and lack of ease of use.Summary of the Invention

[0003] In a first aspect of the subject invention, a cutting device for shaving skin samples and for excising skin lesions or abnormalities is provided, the cutting device including: an elongated cutting blade having spaced-apart first and second longitudinal edges, the first longitudinal edge being sharpened along at least a portion thereof; and, a body including a first grip, a second grip, and a flexible blade support affixed between the first and second grips. The first grip extends between first and second grip ends, and the second grip extends between third and fourth grip ends, with the blade support being located relative to the first grip closer to the first grip end than the second grip end and relative to the second grip closer to the third grip end than the fourth grip end. The first grip end and the third grip end collectively define a leading edge of the body. The cutting blade is supported by the body to extend along the blade support with at least a majority of the first longitudinal edge being proud of the blade support in a direction towards, or beyond, the leading edge of the body. The first grip includes an elongated first grip body disposed transversely to the blade support, with the first grip body extending along a first longitudinal axis. The first grip further includes a first engageable grip portion protruding from the first grip body transversely to the first longitudinal axis and away from the cutting blade, wherein, the first engageable grip portion defines a first free edge which extends between first and second ends, the first end being coincident with the first grip end, the second end being coincident with thesecond grip end. A first point on the first free edge is located at, or adjacent to, the first end and which is the farthermost point of the first free edge from the longitudinal axis.

[0004] In a second aspectof the subject invention, a cutting device for shaving skin samples and for excising skin lesions or abnormalities is provided, the cutting device including: an elongated cutting blade having spaced-apart first and second longitudinal edges, the first longitudinal edge being sharpened along at least a portion thereof; and, a body including a first grip, a second grip, and a flexible blade support affixed between the first and second grips, wherein the first grip extends between first and second grip ends, the second grip extends between third and fourth grip ends, the blade support being located relative to the first grip closer to the first grip end than the second grip end, the blade support being located relative to the second grip closer to the third grip end than the fourth grip end, the first grip end and the third grip end collectively defining a leading edge of the body, wherein the cutting blade is supported by the body to extend along the blade support with at least a majority of the first longitudinal edge being proud of the blade support in a direction towards the leading edge of the body, the cutting blade is spaced from the leading edge of the body with no portion of the cutting blade extending beyond the leading edge of the body, the first longitudinal edge being offset a distance in the range of .090” - .250” from the leading edge of the body.

[0005] In a third aspect of the subject invention, a cutting device for shaving skin samples and for excising skin lesions or abnormalities is provided, the cutting device including: an elongated cutting blade having spaced-apart first and second longitudinal edges, the first longitudinal edge being sharpened along at least a portion thereof; and, a body including a first grip, a second grip, and a flexible blade support affixed between the first and second grips, wherein the first grip extends between first and second grip ends, the second grip extends between third and fourth grip ends, the blade support being located relative to the first grip closer to the first grip end than the second grip end, the blade support being located relative to the second grip closer to the third grip end than the fourth grip end, the first grip end and the third grip end collectively defining a leading edge of the body, wherein the cutting blade is supported by the body to extend along the blade support with at least a majority of the first longitudinal edge being proud of the blade support in a direction towards, or beyond, the leading edge of the body. The blade support is elongated and includes a first axially extending portion formed of a first material of a first durometer and a second axially extending portion formed of a second material of a second durometer, the second durometer being less than the first durometer.

[0006] In a fourth aspect of the subject invention, a cutting device for shaving skin samples and for excising skin lesions or abnormalities is provided, the cutting device including: an elongated cutting blade having spaced-apart first and second longitudinal edges, the first longitudinal edge being sharpened along at least a portion thereof; a body including a first grip, a second grip, and a flexible blade support affixed between the first and second grips, wherein the first grip extends between first and second grip ends, the second grip extends between third and fourth grip ends, the blade support being located relative to the first grip closer to the first grip end than the second grip end, the blade support being located relative to the second grip closer to the third grip end than the fourth grip end, the first grip end and the third grip end collectively defining a leading edge of the body, wherein the cutting blade is supported by the body to extend along the blade support with at least a majority of the first longitudinal edge being proud of the blade support in a direction towards, or beyond, the leading edge of the body; and a guard detachably attached to the body to limit access to the first longitudinal edge.

[0007] In a fifth aspect of the subject invention, a cutting device for shaving skin samples and for excising skin lesions or abnormalities is provided, the cutting device including: an elongated cutting blade having spaced-apart first and second longitudinal edges, the first longitudinal edge being sharpened along at least a portion thereof; and, a body including a first grip, a second grip, and a flexible blade support affixed between the first and second grips, wherein the first grip extends between first and second grip ends, the second grip extends between third and fourth grip ends, the blade support being located relative to the first grip closer to the first grip end than the second grip end, the blade support being located relative to the second grip closer to the third grip end than the fourth grip end, the first grip end and the third grip end collectively defining a leading edge of the body, wherein the cutting blade is supported by the body to extend along the blade support with at least a majority of the first longitudinal edge being proud of the blade support in a direction towards, or beyond, the leading edge of the body. First and second sets of spaced-apart reference marks are located along the first longitudinal edge, each of the reference marks being a line extending generally perpendicularly away from the first longitudinal edge, the first and second sets including a same quantity of the reference marks arranged in the same pattern, the first and second sets being symmetrically disposed about a center point of the first longitudinal edge.

[0008] As will be appreciated by those skilled in the art, even though the foregoing are described as different aspects of the subject invention, these aspects are combinable without restriction. For example, any two or more of the aspects may be combined in the same embodiment of acutting device. The aspects are described individually for ease; the presentation on an individual basis does not limit the aspects to be used alone.Brief Description of the Drawings

[0009] Figures 1-30 show different features useable with a cutting device in accordance with the subject invention.Detailed Description

[0010] A cutting device 10 is shown and described herein which is a medical cutting device particularly well-suited for shaving skin samples and for excising skin lesions or other abnormalities. Such procedures are commonly performed in doctor’s offices or as out-patient treatment with the use of a local numbing agent. A sample is typically harvested to check for cancer or other maladies or conditions.

[0011] With reference to Figure 1 , the cutting device 10 generally includes an elongated cutting blade 12 and a body 14. The body 14 includes a first grip 16, a second grip 18, and a flexible blade support 20 affixed between the first and second grips 16, 18. Preferably, the blade support 20 is located to be closer to a leading edge of the cutting device 10. In particular, the first grip 16 is elongated and extends between first and second grip ends 22, 24. Likewise, the second grip 18 is elongated and extends between third and fourth grip ends 26, 28. The blade support 20 is preferably located relative to the first grip 16 closer to the first grip end 22 than the second grip end 24, and located relative to the second grip 18 closer to the third grip end 26 than the fourth grip end 28. The first grip end 22 and the third grip end 26 collectively define a leading edge 30 of the body 14.

[0012] The cutting blade 12 is elongated with spaced-apart first and second longitudinal edges 32, 34. The first longitudinal edge 32 is sharpened along at least a portion thereof. Any singleedge blade may be utilized having a cutting edge sufficiently sharp to excise skin, including shallow cuts. As will be appreciated by those skilled in the art, a double-edged blade may be utilized, although it will be recognized that the second cutting edge may be of little to no utility. The cutting blade 12 is preferably provided in an initial flat state but should be flexible in causing to be bent into a general U-shape for use with inward force applied to the first and second grips 16, 18. The cutting blade 12 preferably is sufficiently flexible to elastically deform when flexing, having resiliency to return to a generally flat state when the inward force is removed from the first and second grips 16, 18. Cutting blades used in prior cutting devices may be used as the cutting blade 12 in connection with the subject invention.

[0013] The cutting blade 12 is supported by the body 14 to extend along the blade support 20 with at least a majority of the first longitudinal edge 32 being proud of the blade support 20 in a direction towards, or beyond, the leading edge 30 of the body 14. The cutting blade 12 may be secured to the body 14 in any known manner. Preferably, the body 14 is formed of thermoplastic material and the cutting blade 12 is metallic. Portions of the body 14, particularly about the blade support 20, may be molded about portions (e.g., ends) of the cutting blade 12, using for example insert molding techniques. In this manner, portions of the cutting blade 12 would be overmolded by portions of the body 14. In addition, or alternatively, the body 14 may be provided with mounting features, such as posts, onto which the cutting blade 12 may be mounted. Interference fits and / or deformation may be used to fix the cutting blade 12 to the body 14. For example, the cutting blade 12 may be provided with mounting holes formed to mount onto mounting posts on the body 14. Interference fits may be utilized, orthe posts may be deformed, to retain the cutting blade 12 on the mounting posts once mounted.

[0014] It is preferred that clearance be provided between the cutting blade 12 and the blade support 20. This allows for deformation of the blade support 20 during use without interference in flexing the cutting blade 12. As shown in Figure 2, the blade support 20 may be arched away from the cutting blade 12 to provide a clearance.

[0015] For use, the cutting device 10 is engaged by one hand of a user (medical practitioner) with the thumb of the hand pressing against the first grip 16, and one or more fingers of the same hand pressing against the second grip 18. Inward force is applied to the cutting device 10 by urging the first and second grips 16, 18 together, particularly in an inward and upward direction, resulting in the cutting blade 12 flexing. The cutting blade 12 should flex in a direction away from the blade support 20 so that the nadir of the cutting blade 12 is the most spaced portion of the cutting blade 12 from the blade support 20. The blade support 20 will additionally deflect with the cutting blade 12. The blade support 20 preferably deflects to generally the same shape as the flexed cutting blade 12. In this manner, the blade support 20 prevents the cutting blade 12 from folding or creasing, rather than bowing, under application of force. The curved nadir of the cutting blade 12 is pressed against the patient’s skin to shave a sample or to excise a lesion or other abnormality. The cutting device 10 is manually deflected and caused to cut the skin of the patient. To avoid cross-contamination of samples and between patients, the cutting device 10 may be single use, with disposal after use.

[0016] It is noted that the first and second grips 16, 18 are similarly formed. For illustrative purposes, the structure of the first grip 16 is described. The second grip 18 is formed in the same manner.

[0017] The first grip 16 includes an elongated first grip body 36 disposed transversely to the blade support 20. The first grip body 36 extends along a first longitudinal axis LA which is transverse to the blade support 20. The first grip 16 further includes a first engageable grip portion 38 protruding from the first grip body 36 transversely to the first longitudinal axis LA and away from the cutting blade 12. The first engageable grip portion 38 defines a first free edge 40 which extends between first and second ends 42, 44. The first end 42 is coincident with the first grip end 22, and the second end 44 is coincident with the second grip end 24. A first point 46 on the first free edge 40 is located at, or adjacent to, the first end 42 and which is the farthermost point of the first free edge 40 from the longitudinal axis LA. The first point 46 defines a first distance D1 from the first longitudinal axis LA which is greater than any other distance defined between the first free edge 40 and the first longitudinal axis LA. With location of the farthermost point of the first free edge 40 at, or adjacent to, the first end 42, the first free edge 40 defines a raised portion for receiving a finger of a user. The raised portion provides stability in restricting movement past the leading edge 30 and also acts to partially re-direct any laterally applied force in a direction parallel to the cutting blade 12. In addition, the raised portion prevents the device from rotating backwards while cutting and ensures a more even cut over the length of the cut area. Better force application may be achieved particularly when encountering more difficult skin cut areas.

[0018] The first free edge 40 is preferably arcuate between the first and second ends 42, 44. Chamfers or rounded corners may be provided at the first and second ends 42, 44 to avoid sharp corners. For example, a chamfer or rounded corner may be provided between the first end 42 and the first point 46. The first free edge 40 preferably has a concave depression 48 adjacent to the first point 46, for receiving a finger of a user. A second point 50 may be provided on the first free edge 40 located at, or adjacent to, the second end 44 and which is located a second distance D2 from the first longitudinal axis LA, which is less than the first distance D1 , but greater than a third distance D3 of a third point 52 located intermediate (and spaced from) the first and second points 46, 50. With this arrangement, the interior of the first free edge 40 is curved inwardly between the first and second ends 42, 44. A chamfer or rounded corner may be provided between the second end 44 and the second point 50.

[0019] With the first and second grips 16, 18 being similarly formed, as shown in Figure 1 , the distance between the first point 46 of the first grip and the first point 46 of the second grip 18defines the device width DW (the greatest width of the cutting device 10) which is preferably in the range of 2.25” - 2.50”.

[0020] As shown in Figures 5A-5C, and as will be appreciated by those skilled in the art, the first free edge 40 may be formed with various configurations, including having; a second concave depression 54 separated from the depression 48 by a raised ridge 56 (Figure 5A), a plurality of spaced-apart teeth 58 (Figure 5B), and a plurality of scallops 60 (Figure 5C). In addition, as shown in Figure 1 , the first free edge 40 may be provided with friction-enhancing features, such as raised ribs, raised buttons, hollows, knurling, and the like. In addition, the first free edge 40 may be coated (e.g., with an elastomeric material) or otherwise treated to enhance grip therewith. As shown in Figure 29, the first engageable grip portion 38 of the first gri p16 may be wholly formed from an elastomer, such as a silicone. Preferably, the elastomer has a durometer of 80-95 Shore A. In addition, the first grip body 36 may be formed from a thermoplastic provide structure to the cutting device 10 with the elastomer providing an enhanced grip surface. The second grip 18 may be formed in similar fashion (with part 38 being formed of the elastomer and part 36 being formed of thermoplastic). The blade support 20 may be formed unitarily of thermoplastic with the grip bodies 36 of both the first and second grips 16, 18.

[0021] Figures 24-28 show an embodiment of the cutting device 10 where the first free edge 40 is provided with a plurality of raised ribs 100. As shown in the Figures, each of the raised ribs 100 is elongated and wraps about the first engageable grip portion 38. The raised ribs 100 may each have an arcuate cross section, so as to be rounded in profile throughout. The first point 46 may be defined on a first raised rib 100A, particularly at a location on the first raised rib 100A which is the farthermost point of the first raised rib 100A from the first longitudinal axis LA (the first point 46 being the first distance D1 from the first longitudinal axis LA). An outer edge 102 of the first raised rib 100A may be coincident with the first end 42. In addition, a second raised rib 100B may have an outer edge 104 which coincides with the second end 44. The second point 50 may be defined on the second raised rib 100B, particularly at a location on the second raised rib 100B which is the farthermost point of the second raised rib OBfrom the first longitudinal axis LA (the second point 50 being the second distance D2 from the first longitudinal axis LA). With the first distance D1 being greater than the second distance D2, as discussed above, the first point 46 is located further from the first longitudinal axis LA than the second point 50 thereby providing a raised portion for a user’s finger or thumb, having the advantages discussed above.

[0022] As shown in Figures 26 and 30, the first free edge 40 may have a profile with two or more profile portions defined by more than one radius. By way of non-limiting example, the first freeedge 40 may have a profile with a first profile portion 106 which extends from the first raised rib 100A towards the second raised rib 100B. The first profile portion 106 may be defined about a first radius R1 . In addition, the first free edge 40 may have a profile with a second profile portion 108 which extends from the second raised rib 100B towards the first raised rib 100A. The second profile portion 108 may be defined about a second radius R2. The first profile portion 106 coincides with the second profile portion 108 at a meeting point 110 along the first free edge 40 spaced from both the first and second ends 42, 44, with the second radius R2 being larger than the first radius R1 . The first radius R1 may be 0.8” with the second radius R2 being 3.5” (the ratio of the second radius R2 to the first radius R1 being 4.375:1 ). The second radius R2 may be more than four times greater than the first radius R1 , more preferably, being four to six times greater. This arrangement provides the raised portion with a smooth arcuate transition to the remainder of the first free edge 40. Preferably, the meeting point 110 coincides with the location of the third point 52 along the first free edge 40, the third point 52 being located the third distance D3 from the first longitudinal axis LA (the portion of the first free edge 40 coinciding with the meeting point 110 being located closer to the first longitudinal axis LA than both the first and second points 46, 50). Further, preferably, the meeting point 110 is equally spaced from both the first and second ends 42, 44.

[0023] The raised ribs 100 may be evenly spaced between the first and second raised ribs 100A, 100B. With the first free edge 40 having a profile including the first profile portion 106 and the second profile portion 108, the raised ribs 100 may be evenly distributed between the two profile portions with half of the raised ribs 100 being disposed along the first profile portion 106 and the other half of the raised ribs 100 being disposed along the second profile portion 108, as shown in Figure 26. In addition, as shown in Figure 24, each of the raised ribs 100 may be disposed generally perpendicularly to the first longitudinal axis LA.

[0024] In addition, each of the raised ribs 100 may be provided with a width W, as measured in a directed parallel to the first longitudinal axis LA. Moreover, adjacent pairs of the raised ribs 100 may be each separated by a spacing S. Each of the spacings S may be also provided with the width W, as measured in a direction parallel to the first longitudinal axis LA. With this arrangement, the raised ribs 100 are evenly spaced along the first free edge 40 with equal separating spacings S. With an even distribution of similar dimensioned ribs 100 and spacings S, a user may be provided with a comfortable grip arrangement which enhances a user’s ability to maintain constant contact with the device throughout use.

[0025] To provide mechanical advantage to a user, the first engageable grip portion 38 may be angled downwardly. In addition, the body 14 may include a first flange 62 extendingalongthefirst grip body 36 to which is connected the blade support 20. The first grip body 36 may be disposed to extend upwardly (in a direction from the cutting blade 12 to the blade support 20) and outwardly (in a direction away from the second grip 18) from the first flange 62. In addition, the first grip body 36 terminates in a free edge 64 away from the first flange 62. The first engageable grip portion 38 may be connected to the first grip body 36 along the free edge 64 with the first engageable grip portion 38 extending downwardly (in a direction from the blade support 20 to the cutting blade 12) and outwardly from the first grip body 36. In addition, as shown in Figures 24, 27, and 28, an elongated strip 112 may be provided along the first grip body 36, above the first flange 62, to define an upward facing, exposed surface marking surface 114.

[0026] A grip length GL measured between the first and second grip ends 22, 24 preferably should be within a range of 0.650” - 1.700”, more preferably, 0.650” - 1.500”, more preferably, 0.688” - 1.500”, more preferably, 0.80” - 1.500”, and, more preferably, 0.875” - 1.450”. More preferably, the grip length GL may be in the range of 0.80” - 1 .00”. The grip length GL is based upon a user grasping the cutting device 10 with a thumb on the first grip 16 and one or two fingers on the second grip 18. This grip length GL may be based upon average human finger dimensions (e.g., 16-20 mm width of an average human index finger; 22 mm width of an average human thumb). If the grip length GL is too short, the user may not be able to securely grip the cutting device 10 with two fingers on one side. This may cause discomfort and loss of control when using the cutting device 10 during a procedure. If the grip length GL is too long, the cutting device 10 may become unbalanced and difficult to bow the cutting device 10 into the desired radius profile. In addition, if the grip length GL is too long, the cutting device 10 may be perceived as being too large to make smaller, precise cuts, especially when used by persons with smaller hands / fingers. The grip length GL is preferably equal on both the first second grips 16, 18 to allow for ambidextrous use and allow a user to determine which two or three fingers to use during a procedure. As will be appreciated by those skilled in the art, the grip length GL may be varied for the first and second grips 16, 18 to allow for right-hand or left-hand specific configurations by making one grip length GL shorter and the other grip length GL longer for thumb engagement on one grip and two fingers engagement on the other grip.

[0027] With reference to Figure 6, the first longitudinal edge 32 may be spaced from the leading edge 30 with no portion of the cutting blade 12 extending beyond the leading edge 30 with the first longitudinal edge 32 being offset from the leading edge 30 of the body 14a distance X in the range of .090” - .250”. It has been found that if the first longitudinal edge 32 is too far forward (i.e., tooclose to the leading edge 30), the cutting device 10 may rotate forward and downward in the user’s hand during use, especially when cutting a harder material. If the first longitudinal edge 32 is offset more than .250” from the leading edge 30, the cutting device 10 may drag thereby being difficult in preventing from cuttingdeeperthan desired. A uniform cuttingdepth is desired. Blade position may influence control and ease of use of the cutting device 10.

[0028] With reference to Figure 7, the blade support 20 may be formed from more than one material. This allows for different material characteristics being achieved from simultaneous use of disparate materials. For example, as shown in Figure 7, the blade support 20, being elongated, may include a first axially extending portion 66 formed of a first material of a first durometer. In addition, the blade support 20 may include a second axially extending portion 68 formed of a second material of a second durometer. The first material may be a thermoplastic and the second material may be an elastomer. In this manner, the first axially extending portion 66 may be formed thinner being reinforced with the second axially extending portion 68. The second axially extending portion 68 may be overmolded on the first axially extending portion 66 using known molding techniques. As shown in Figure 7, the second axially extending portion 68 may be provided as an elongated rib along the blade support 20, acting as a spine therefor.

[0029] As shown in Figures 8 and 9, the cutting device 10 may be provided with a guard 70 detachably attached to the body 14 to limit access to the first longitudinal edge 32 of the cutting blade 12. The guard 70 may be detachably attached to the leading edge 30 (Figure 9) or detachably attached to the body 14 to protrude from the leading edge 30 of the body 14 (Figures 2 and 9). The guard 70 may be formed with the body 14, e.g., by molding, with weakened points of attachment to allow for detachment and removal of the guard 70. The guard 70 spans across, in alignment with, the first longitudinal edge 32 to prevent inadvertent contact therewith prior to use. It is noted that the guard 70 may be spaced from the cutting blade 12 and not in direct contact therewith. The guard 70 is preferably located to block touching of the first longitudinal edge 32. The guard 70 is removed once ready.

[0030] As shown in Figures 12-23, the guard 70 may be formed to be re-attachable post-use to limit access to the first longitudinal edge 32 in a contaminated state. To facilitate re-attachment, the guard 70 is provided with at least one retaining post 78 which are receivable corresponding one or more holes 80 formed on the body 14. As shown in Figures 12-17, the at least one retaining post 78 is provided to be upstanding on an upward facing surface of the guard 70 which is received in downward facing hole(s) 80 formed on the body 14. The hole(s) 80 may be through-holes extending through the body 14 (as shown in Figures 12 and 14) or blind holes with limited depthinto the body 14. With this arrangement, the guard 70 is pulled downwardly for removal and reattached by inserting the at the least one retaining post 78 into the corresponding hole(s) 80. Preferably, two of the posts 78 are provided which are spaced-apart on the guard 70. In addition, the guard 70 may be provided with a first flat section 82, from which the post(s) 78 protrude, and a second flat section 84, raised above the first flat section 82. With this arrangement, the second flat section 84 is positioned to be generally coplanar with the cutting blade 12 in restricting access to the first longitudinal edge 32 with the first flat section 82 being below the cutting blade 12 for mounting to the body 14. A vertical transition 86 is provided between the first and second flat sections 82, 84. Preferably, the first and second flat sections 82, 84 are generally parallel. The post(s) 78 may be provided with a ring or enlarged cross-section for an interference fit in the hole(s) 80.

[0031] As a further alternative, as shown in Figures 18-23, the hole(s) 80 may be provided along the leading edge 30 with the post(s) 78 protruding from an edge of the guard 70. In this manner, the guard 70 may be detachably mounted and re-mounted to the leading edge 30. Here, the guard 70 may be formed planar (in one plane) being mounted to be aligned with the first longitudinal edge 32.

[0032] As shown in Figures 10 and 11 , first and second sets of spaced-apart reference marks 72, 74 may be located along the first longitudinal edge 32, particularly on an upward facing surface of the cutting blade 12. Each of the reference marks 76 is a line extending generally perpendicularly away from the first longitudinal edge 32. The first and second sets 72, 74 preferably include the same quantity of the reference marks 76 arranged in the same pattern (same spacings), with the first and second sets 72, 74 being symmetrically disposed about a center point CL of the first longitudinal edge 32. As shown schematically in Figure 11 , with the cutting blade 12 flexed into a U-shape for use, the first and second sets 72, 74 are arranged to be in facing arrangement symmetrically about the center point CL. The reference marks 76 are thus paired with opposing reference marks 76 to represent different heights (H1 , H2, H3, H4) from the bottom of the first longitudinal edge 32 with the cutting blade 12 in the flexed condition (i.e., from the nadir of the flexed cutting blade 12). This acts as a depth gauge for a practitioner in providing reference to how deep the cutting blade 12 should be driven into a patient’s skin.

[0033] The reference marks 76 may be applied to the cutting blade 12 using any known technique, including printing, etching, embossing, and so forth. The reference marks 76 may be raised relative to the upward surface of the cutting blade 12, presented flat on the upward surface of the cutting blade 12, and / or, recessed in the upward surface of the cutting blade 12, orvariouscombinations thereof. Any technique to indelibly present the reference marks 76 on the cutting blade 12 may be utilized. In addition, the reference marks 76 preferably are provided with color, particularly color contrasting with the cutting blade 12 for good visualization.

[0034] Testing was conducted of the embodiment of the cutting device 10 shown in Figures 24- 28 and 30 (“the Test Cutting Device”) to simulate the amount of cutting force needed to lose control over the Test Cutting Device. The testing was arranged to comparatively test the amount of cut force needed to simulate loss of device control of the Test Cutting Device in comparison to the amount of cut force needed to simulate a loss of device control of the prior art DERMABLADE cutting device (described in the above “Background of the Invention” section). For purposes of this testing, a loss of device control was defined as a rotation of 15 degrees from an initial horizontal position. The tests determined the amount of force needed to rotate the test devices 15 degrees from horizontal.

[0035] Four samples of both the Test Cutting Device and the DERMABLADE cutting device were each tested in two positions: in a flat cut position and in a half flex cut position (cutting device is flexed halfway between flat and fully flexed). The cutting devices were held in a test stand for testing. The test stand was configured to apply generally the same amount of inward force (in a direction between the grips) to hold the relevant cutting device in an initial horizontal position with the cutting blade being forward facing. The samples of the Test Cutting Device had a greater width than that of the DERMABLADE cutting devices, the difference in width being accounted for in testing with spacers to generally apply the same amount of inward force to all samples. A force gauge (Chatillon force gauge, Model DPP - 1 kg) was used to measure force applied against the initially horizontal cutting blade. The amount of force needed to rotate each sample, in each position, to 15 degrees from horizontal was noted and deemed to be the amount of cut force needed to simulate a loss of device control. The results of the testing are shown in Table 1 .Table 1(%-lncrease in Ave. Cut Force calculated by determining percentage increase of the average cut force of the Test Cutting Device compared to the DERMABLADE Cutting Device for each position.)

[0036] Based on this testing, it was found that the Test Cutting Device required an approximately 270% greater average amount of cut force in a flat position to lose device control than that of theDERMABLADE cutting device. This is a significant difference, with the Test Cutting Device requiring significantly higher cutting force to lose device control in a flat position. Likewise, it was found that the Test Cutting Device required a 200% greater average amount of cut force in a1 / 2flex position than that of the DERMABLADE cutting device to lose device control. Again, the Test Cutting Device is shown to require significantly higher cutting force to lose device control. It is believed that the raised portions along the leading edge of the Test Cutting Device contribute significantly to the noted advantages of the Test Cutting Device. The DERMABLADE cutting device does not have such raised portions.

[0037] It is noted that rotation of 15 degrees, or more, in a user’s hand during use is excessive and may lead to harm to a patient or the user. Certain cuts may require a high amount of cutting force. Maintenance of control during such cuts is important. Requiring higher amounts of cutting force to lose device control provides users with higher assurance during use, along with greater safety.

Claims

What is claimed is:1 . A cutting device for shaving skin samples and for excising skin lesions or abnormalities, the cutting device comprising: an elongated cutting blade having spaced-apart first and second longitudinal edges, the first longitudinal edge being sharpened along at least a portion thereof; and, a body including a first grip, a second grip, and a flexible blade support affixed between the first and second grips, wherein the first grip extends between first and second grip ends, the second grip extends between third and fourth grip ends, the blade support being located relative to the first grip closer to the first grip end than the second grip end, the blade support being located relative to the second grip closer to the third grip end than the fourth grip end, the first grip end and the third grip end collectively defining a leading edge of the body, wherein the cutting blade is supported by the body to extend along the blade support with at least a majority of the first longitudinal edge being proud of the blade support in a direction towards, or beyond, the leading edge of the body, wherein, the first grip includes an elongated first grip body disposed transversely to the blade support, the first grip body extending along a first longitudinal axis, the first grip further including a first engageable grip portion protruding from the first grip body transversely to the first longitudinal axis and away from the cutting blade, wherein, the first engageable grip portion defines a first free edge which extends between first and second ends, the first end being coincident with the first grip end, the second end being coincident with the second grip end, wherein, a first point on the first free edge is located at, or adjacent to, the first end and which is the farthermost point of the first free edge from the first longitudinal axis.

2. The cutting device of claim 1 , wherein: the first point is located a first distance from the first longitudinal axis, a second point on the first free edge is located at, or adjacent to, the second end and which is located a second distance from the first longitudinal axis, the first distance being greater than the second distance, and, a third point on the first free edge is spaced from both the first and second points, the third point being located a third distance from the first longitudinal axis which is less than the second distance.

3. The cutting device of claim 1 , wherein the first free edge is scalloped along its length.

4. The cutting device of claim 1 , wherein the first free edge defines a first depression adjacent to the first point for receiving a finger of a user.

5. The cutting device of claim 4, wherein the first free edge defines a second depression between the first depression and the second end for receiving a second finger of a user, a raised ridge separating the first and second depressions.

6. The cutting device of claim 1 , wherein the first free edge defines a plurality of spaced- apart teeth along its length.

7. The cutting device of claim 1 , wherein a plurality of raised ribs is formed on the first free edge.

8. The cutting device of claim 7, wherein each of the plurality of raised ribs is elongated and wraps about the first engageable grip portion, and, wherein the first point is defined on a first of the raised ribs at the farthermost point of the first raised rib from the first longitudinal axis.

9. The cutting device of claim 8, wherein an outer edge of the first raised rib coincides with the first end.

10. The cutting device of claim 9, wherein a second of the raised ribs has an outer edge which coincides with the second end, wherein a second point on the first free edge is located on the second raised rib at the farthermost point of the second raised rib from the first longitudinal axis, the second point being located a second distance from the first longitudinal axis, and wherein the first point is located a first distance from the first longitudinal axis, the first distance being greater than the second distance.

11. The cutting device of claim 10, wherein the plurality of raised ribs is evenly spaced between the first and second raised ribs.

12. The cutting device of claim 11 , wherein each of the plurality of raised ribs is disposed generally perpendicularly to the first longitudinal axis.

13. The cutting device of claim 10, wherein the first free edge includes a profile with a first profile portion extending from the first raised rib towards the second raised rib, the first profile portion being defined about a first radius, wherein the profile of the first free edge includes a second profile portion extending from the second raised rib towards the first raised rib, the second profile portion being defined about a second radius, wherein the second profile portioncoincides with the first profile portion at a meeting point along the first free edge spaced from both of the first and second ends, and wherein the second radius is larger than the first radius.

14. The cutting device of claim 13, wherein half of the plurality of raised ribs is disposed along the first profile portion, and the other half of the plurality of raised ribs is disposed along the second profile portion.

15. The cutting device of claim 13, wherein the meeting point on the first free edge is located a third distance from the first longitudinal axis which is less than the second distance.

16. The cutting device of claim 15, wherein the meeting point is equally spaced from both the first and second ends.

17. The cutting device of claim 13, wherein the second radius is more than four times larger than the first radius.

18. The cutting device of claim 8, wherein the first raised rib has a width in a direction parallel to the first longitudinal axis, wherein a secondary raised rib is disposed adjacent to the first raised rib, the secondary raised rib having the same width as the first raised rib, and wherein, a space is provided between the first and secondary raised ribs, the space having the same width as the first raised rib.

19. The cutting device of claim 1 , wherein the distance between the first and second grip ends of the first grip is in the range of 0.650” - 1 .700”.

20. The cutting device of claim 19, wherein the distance between the first and second grip ends of the first grip is in the range of 0.80” - 1 .0”.21 . The cutting device of claim 1 , wherein the body includes a first flange extending along the first grip body, the blade support being connected to the first flange, the first grip body extending upwardly, in a direction from the cutting blade to the blade support, and outwardly, in a direction away from the second grip, from the first flange.

22. The cutting device of claim 21 , wherein the first grip body terminates in a free edge away from the first flange, and, wherein the first engageable grip portion is connected to the first grip body along the free edge, the first engageable grip portion extending downwardly, in a direction from the blade support to the cutting blade, and outwardly from the first grip body.

23. The cutting device of claim 22, wherein the first grip body is formed from a thermoplastic and the first engageable grip portion is formed from an elastomer.

24. The cutting device of claim 1 , wherein the cutting blade is spaced from the leading edge of the body with no portion of the cutting blade extending beyond the leading edge of the body, and wherein the first longitudinal edge being offset a distance in the range of .090” - .250” from the leading edge of the body.

25. A cutting device for shaving skin samples and for excising skin lesions or abnormalities, the cutting device comprising: an elongated cutting blade having spaced-apart first and second longitudinal edges, the first longitudinal edge being sharpened along at least a portion thereof; and, a body including a first grip, a second grip, and a flexible blade support affixed between the first and second grips, wherein the first grip extends between first and second grip ends, the second grip extends between third and fourth grip ends, the blade support being located relative to the first grip closer to the first grip end than the second grip end, the blade support being located relative to the second grip closer to the third grip end than the fourth grip end, the first grip end and the third grip end collectively defining a leading edge of the body, wherein the cutting blade is supported by the body to extend along the blade support with at least a majority of the first longitudinal edge being proud of the blade support in a direction towards the leading edge of the body, the cutting blade is spaced from the leading edge of the body with no portion of the cutting blade extending beyond the leading edge of the body, the first longitudinal edge being offset a distance in the range of .090” - .250” from the leading edge of the body.

26. A cutting device for shaving skin samples and for excising skin lesions or abnormalities, the cutting device comprising: an elongated cutting blade having spaced-apart first and second longitudinal edges, the first longitudinal edge being sharpened along at least a portion thereof; and, a body including a first grip, a second grip, and a flexible blade support affixed the first and second grips, wherein the first grip extends between first and second grip ends, the second grip extends between third and fourth grip ends, the blade support being located relative to the first grip closer to the first grip end than the second grip end, the blade support being located relative to the second grip closer to the third grip end than the fourth grip end, the first grip end and the third grip end collectively defining a leading edge of the body, wherein the cutting blade is supported by the body to extend along the blade support with at least a majority of the first longitudinal edge being proud of the blade support in a direction towards, or beyond, the leading edge of the body,wherein the blade support is elongated and includes a first axially extending portion formed of a first material of a first durometer and a second axially extending portion formed of a second material of a second durometer, the second durometer being less than the first durometer.

27. The cutting device of claim 26, wherein the first material is a thermoplastic and the second material is an elastomer.

28. A cutting device for shaving skin samples and for excising skin lesions or abnormalities, the cutting device comprising: an elongated cutting blade having spaced-apart first and second longitudinal edges, the first longitudinal edge being sharpened along at least a portion thereof; a body including a first grip, a second grip, and a flexible blade support affixed between the first and second grips, wherein the first grip extends between first and second grip ends, the second grip extends between third and fourth grip ends, the blade support being located relative to the first grip closer to the first grip end than the second grip end, the blade support being located relative to the second grip closer to the third grip end than the fourth grip end, the first grip end and the third grip end collectively defining a leading edge of the body, wherein the cutting blade is supported by the body to extend along the blade support with at least a majority of the first longitudinal edge being proud of the blade support in a direction towards, or beyond, the leading edge of the body; and a guard detachably attached to the body to limit access to the first longitudinal edge.

29. The cutting device of claim 28, wherein the guard is detachably attached to the leading edge of the body.

30. The cutting device of claim 28, wherein the guard is detachably attached to the body to protrude from the leading edge of the body.31 . A cutting device for shaving skin samples and for excising skin lesions or abnormalities, the cutting device comprising: an elongated cutting blade having spaced-apart first and second longitudinal edges, the first longitudinal edge being sharpened along at least a portion thereof; and, a body including a first grip, a second grip, and a flexible blade support affixed between the first and second grips, wherein the first grip extends between first and second grip ends, the second grip extends between third and fourth grip ends, the blade support being located relativeto the first grip closer to the first grip end than the second grip end, the blade support being located relative to the second grip closer to the third grip end than the fourth grip end, the first grip end and the third grip end collectively defining a leading edge of the body, wherein the cutting blade is supported by the body to extend along the blade support with at least a majority of the first longitudinal edge being proud of the blade support in a direction towards, or beyond, the leading edge of the body, wherein, first and second sets of spaced-apart reference marks are located along the first longitudinal edge, each of the reference marks being a line extending generally perpendicularly away from the first longitudinal edge, the first and second sets including a same quantity of the reference marks arranged in the same pattern, the first and second sets being symmetrically disposed about a center point of the first longitudinal edge.

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