Medical cutting device

Abstract

The present disclosure relates generally to a medical / surgical cutting device, and more particularly to a medical / surgical cutting device that is structured and configured to move between non-cutting and cutting configurations / positions, capture soft tissue and actuate a blade to the cutting configuration / position outside of a skin incision to transect and obtain a soft tissue graft.

Description

Attorney Docket No. Cl 118 PCT 3MEDICAL CUTTING DEVICEBACKGROUND1. FIELD

[0001] The present disclosure relates generally to a medical / surgical cutting device, and more particularly to a medical / surgical cutting device that is structured and configured to move between non-cutting and cutting configurations / positions, capture soft tissue and actuate a blade to the cutting configuration / position outside of a skin incision to transect and obtain a soft tissue graft.2. DESCRIPTION OF THE RELATED ART

[0002] In the course of surgical procedures such as the harvest of a quad tendon for reconstruction / augmentation of other anatomy in the patient’s body, it is necessary to first expose the quad tendon and provide access to it so that surgical tools may then cut away the tendon and harvest the same. Access for a quad tendon harvest, for example, is often achieved by inserting a surgical retractor device, such as an “Army Navy” style retractor (as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure) into a surgical incision in proximity to the quad tendon, and having a surgical technician (or other member of the operating room staff) hold this retractor in place relative to the patient’s knee for the duration of the quad tendon harvesting procedure, which includes use of a conventional medical cutting device to obtain a tendon graft.

[0003] Description of the Related Art Section Disclaimer: To the extent that specific patents / publications / products are discussed above in this Background Section or elsewhere in this Application, these discussions should not be taken as an admission that the discussed patents / publications / products are prior art for patent law purposes. For example, some or all of the discussed patents / publications / products may not be sufficiently early in time, may not reflect subject matter developed early enough in time and / or may not be sufficiently enabling so as to amount to prior art for patent law purposes. To the extent that specific patents / publications / products are discussed above in this Background Section and / or throughout the application, the descriptions / disclosures of which are all hereby incorporated by reference into this document in their respective entirety(ies).122217730.V1-9 / 9 / 25Atorney Docket No. Cl 118 PCT 3BRIEF SUMMARY

[0004] The inventors of the present disclosure recognize that there are problems and limitations with conventional medical cutting devices and related methods / processes of use. Discussions about conventional (proximal) cutting devices can be found in WO 2021252596, incorporated by reference in its entirety herein. For example, conventional devices and processes require a relatively large incision that exposes the site to allow access to most or all medical / surgical devices involved in a particular procedure including the conventional cutting device (in view, at least in part, on its structural configuration). This can result in a longer recovery time, a higher chance of infection, and a higher incidence of noticeable scarring. Thus, there is a need for an improved medical / surgical cutting device that is structured and configured to at least be able to perform some or all of the same or similar functions needed of a conventional medical / surgical cutting device while facilitating and improving on a minimally invasive harvesting of a soft tissue graft (e.g., quad tendon graft harvest).

[0005] It is therefore a principal object and advantage of the present disclosure to provide a medical / surgical cutting device that eliminates one or more of the problems / issues associated with conventional devices and fulfill the need(s) identified above. A particular non-limiting goal of the utilization of the embodiments and implementations herein is to provide a medical / surgical cutting device that is dynamic and is structured and configured to move between non-cutting and cutting configurations / positions, have components that move with respect to other components, provide a controlled cutting configuration and action, and provide an improved visualization and measurement of a to be cut graft outside of an incision.

[0006] In accordance with an embodiment, a medical / surgical cutting device is provided that includes an elongated body extending along a central longitudinal axis and having a proximal end and a distal end, the distal end having a top surface and a bottom surface; a window positioned through the top surface and the bottom surface of the distal end, at least one wall extending in a direction above the top surface of the distal end and adjacent to the window and forming a distal interior space with the distal end surface; and an elongated blade having a distal end positioned and moveable within the elongated body from a non-cutting configuration not within the window and to a cutting position and configuration within the window.

[0007] The components / portions of the device according to an embodiment can be integrally formed as one molded or monolithic piece, or can have portions / components that are sealed, snapped, screwed, riveted or otherwise connected together during the manufacturing process. The components / portions of the device according to an embodiment can be made from a plastic / biocompatible polymer and / or metal, as should be understood by a person of222217730.V1-9 / 9 / 25Atorney Docket No. Cl 118 PCT 3 ordinary skill in the art in conjunction with this disclosure (and can be single use or can be made from a material that is cleanable (disinfected and sterilized) so that it can be reusable, as should be understood by a person of ordinary skill in the art in conjunction with a review of this disclosure). The components / portions can have rectangular, circular or other shaped cross sections, as should be understood by a person of ordinary skill in the art in conjunction with this disclosure.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Embodiments of the present disclosure will be more fully understood and appreciated by reading the following Detailed Description in conjunction with the accompanying drawings. The accompanying drawings illustrate only typical embodiments of the disclosed subject matter and are therefore not to be considered limiting of its scope, for the disclosed subject matter may admit to other equally effective embodiments.

[0009] Reference is now made briefly to the accompanying drawings, in which:

[0010] FIG. 1 is a side view of a medical / surgical cutting device, according to an embodiment.

[0011] FIG. 2 is a front / distal perspective view of the medical / surgical cutting device, according to an embodiment.

[0012] FIG. 3 is a side sectioned view of the medical / surgical cutting device shown in FIG. 1, according to an embodiment.

[0013] FIG. 4 is a front perspective sectioned and close-up view of the distal end of the medical / surgical cutting device shown in FIG. 3, according to an embodiment.

[0014] FIG. 5 is a perspective top view of a medical / surgical cutting device, according to an alternative embodiment.

[0015] FIG. 6 is a side view of a medical / surgical cutting device, according to an alternative embodiment.

[0016] FIG. 7 is a top view of the medical / surgical cutting device shown in FIG. 6, according to an alternative embodiment.

[0017] FIG. 8 is a side sectioned view of the medical / surgical cutting device shown in FIG.6, according to an alternative embodiment.DETAILED DESCRIPTION

[0018] Aspects of the present embodiments and certain features, advantages, and details thereof, are explained more fully below with reference to the non-limiting examples illustrated in the accompanying drawings. Descriptions of well-known structures are omitted so as not to322217730.V1-9 / 9 / 25Atorney Docket No. Cl 118 PCT 3 unnecessarily obscure embodiments in detail. It should be understood, however, that the detailed description and the specific non-limiting examples, while indicating aspects of the embodiments, are given by way of illustration only, and are not by way of limitation. Various substitutions, modifications, additions, and / or arrangements, within the spirit and / or scope of the underlying inventive concepts will be apparent to those skilled in the art from this disclosure.

[0019] While embodiments of the present disclosure have been particularly shown and described with reference to certain exemplary embodiments, it will be understood by one skilled in the art that various changes in detail may be affected therein without departing from the spirit and scope of the invention as defined by claims that can be supported by the written description and drawings. Further, where exemplary embodiments are described with reference to a certain number of elements it will be understood that the exemplary embodiments can be practiced utilizing either less than or more than the certain number of elements. If elements shown in a particular Figure discussed below are not specifically identified with respect to that Figure, the elements should be sufficiently identified with respect to at least one other Figure.

[0020] The use of terms “proximal” and “distal” are from the point of view of a medical / surgical team member based on when the assembly or parts thereof are in use on a patient.

[0021] Referring to FIG. 1, a side view of a medical / surgical cutting device 100 according to an embodiment is shown. Device 100 is shown in a non-cutting configuration / position and includes a first or proximal end 111, a main body handle / housing 105, an elongated distal shaft or housing 113 extending from a distal end of the main body handle 105 (which can be a separate from and attached to or an integrally formed and an extension of the main body handle / housing), and a second or distal end 115. A trigger / actuator 103 is movably or pivotably connected to the main body handle 105 at a pivot location 107 (which is shown as an aperture but can include a screw or an elongated member which would allow the trigger 103 to pivot about the same, as should be understood by those of ordinary skill in the art).

[0022] Turning to FIG. 2, a front / distal perspective view of the medical / surgical cutting device 100 according to an embodiment is shown. Device 100 is shown in a non-cutting configuration / position with a second / distal end window or opening 101 shown fully open (i.e., not blocked by a blade positioned therethrough) and extending through the top distal end surface 115-1 and bottom distal end surface. Extending above the top distal end surface 115-1 adjacent to the opening is at least one wall 115-3, which forms at least a partial distal interior space 115-5 with the top distal end surface 115-1. Guides 206 are shown on at least an interior422217730.V1-9 / 9 / 25Atorney Docket No. Cl 118 PCT 3 surface of at least one lateral wall 115-3 (or on the interior surface of two of the lateral walls being parallel to each other and extending from a proximal to a distal direction) under (or alternatively upon) which the blade can be actuated. Guides 206 can be positioned and configured to prevent lifting / bending of the blade during cutting. The top surface of the main body handle 105-1 and the transition location 103-1 between the main body handle 105 and the elongated distal shaft 113 are also shown. A graduated portion 102 is detailed out (in preferred units, e.g., mm, cm or inches) on the top surface of the elongated distal shaft 113 by way of etching or printing.

[0023] Turning to FIG. 3, a side sectioned view of the medical / surgical cutting device shown in FIG. 1 according to an embodiment is shown. A blade 201 is shown positioned from and attached at its proximal end to a link 202, and extending in a distal direction from the link 202 and partially into the window 101, under the guide 206 and over top distal end surface 115-1 (in an alternative embodiment, the distal end of the blade can be positioned and be movable over the guide 206). In this example, blade 201 is a guillotine style cutter that generally defines a thin planar element (although additional blade embodiments are contemplated, and the blade can be angled at less or more than 90 degrees to the central longitudinal axis or can be angled at 90 degrees to the central longitudinal axis) and can extend in a plane that is substantially parallel to that of the top surface 105-1. In some embodiments, the blade 201 is replaceable, as having a fresh blade for each procedure can ensure a consistently sharp edge and a more consistent and precise slice through the fibrous tendon tissue. In this example, the window defines an opening that is sized and dimensioned to receive a tendon or graft strip. In some embodiments, the window opening has a proximal sharp edge opposite the distal blade edge configured to dissect tissue, but not as sharp as the blade (but can be as sharp or sharper). In an alternative embodiment, the blade can be long and wide enough to be positioned within window 101 and cut a tendon as discussed herein, and can be attached to a rod or other longitudinal element that is itself attached to the link 202. In other words, the blade does not have to be directly attached to the link 202, but can be attached to another longitudinal element that is itself attached to and operable / actuatable via the link 202.

[0024] A distal end of a spring 204 is attached to a connection point at a proximal end 204-2 of the link 202, and a proximal end of the spring is connected to a connection point 204-1 (e.g., bolt, rivet, flange) within the interior of the body at the proximal end (or exterior, or both, of the device (via hook, wrapped portion of the spring or otherwise)). The spring imparts a proximal direction bias against the blade 201 keeping it in the non-cutting configuration / position. The trigger 203 has been partially (not fully) actuated (pulled522217730.V1-9 / 9 / 25Atorney Docket No. Cl 118 PCT 3 proximally) in FIG. 3, pivoting about pivot location 107. Another screw or elongated member 207 is positioned through a second end of the trigger 203 within the handle 205. When the trigger 203 is actuated proximally and pivots about pivot location 107, the second end 209 moves distally. When the second end moves distally and overcomes the proximal direction bias of the spring 204, the blade 201 moves distally through the elongated distal shaft 113 and the distal sharp end is exposed and moves into and through at least a non-full portion (and can move fully through) the window 101 to a cutting configuration / position (FIGS. 3-4 show a partial non-full cutting configuration / position). When the trigger is released, the spring is structured, positioned, and configured to proximally retract the blade back to the non-cutting configuration / position. Cover 205 is a layer of material that is positioned above the blade in the elongated distal shaft 113 and is positioned and configured to prevent buckling of the blade 201.

[0025] Referring to FIG. 4A, a front perspective sectioned and close-up view of the distal end of the device 100 shown in FIG. 3 is shown. The portion of the soft tissue graft that is intended to be transected 302 (tendon - to be formed into a soft graft - 302 (e.g., quad tendon)) can be fed through the underside of the window 101 placing the graft extending in a proximal direction along the top, graduated portion 102 that can reference the length of the desired graft. Pulling of the trigger 103 distally advances the blade to transect the graft. A raised surface 301 on a wall adjacent to the window 101 where the graft 302 exits, is designed / configured to angle the graft, so that it is arranged approximately perpendicular to the exposed cutting portion 303 of the blade. This structural configuration aids in preventing a tapered formed end of the graft 302 based on the bladed cut. The ability of device 100 to capture a soft tissue graft and actuate a blade outside of a skin incision (not shown), allows for accessing the cutting location through a small skin incision, instead of a larger incision that exposes the site (as is done per conventional devices). A close-up perspective view of the blade 201 is shown in FIG. 4B. The cutting portion 303 of the blade can be sharpened on one side with a beveled edge (as shown, but does not have to be) to aid in lifting the graft 302 until it contacts the end of the window. In some embodiments, the most distal portion 303 A of the cutting portion can be wider or narrower in width than the most proximal portion 303B. In other embodiments, the widths of the two portions are substantially equal. In some embodiments, one or more edges of the cutting portion can be sharp so as to sufficiently cut tissue as discussed herein (e.g., 303 A, 303B, and / or side edges therebetween).

[0026] In accordance with an alternative embodiment, a perspective top view of a medical / surgical cutting device 100’ (in a non-cutting configuration / position) is shown in FIG.622217730.V1-9 / 9 / 25Atorney Docket No. Cl 118 PCT 35. Device 100’ is similar in many respects to device 100, described above, including the structure and configuration of the distal end 115. However, the actuator in device 100’ is a plunger actuator 103’ at the proximal end 111 (which is in line with the central longitudinal axis of the device 100’) vs. a trigger actuator 103 in device 100. A handle 105’ is positioned distally from the plunger actuator 103’ and can include one or more wings for a user’s fingers to grip while in use. The plunger actuator 103’ can (but does not have to) be biased proximally by a spring (not shown) positioned within the body, which needs to be overcome by pushing the plunger actuator 103’ in a distal direction to move the cutting portion 303 of the blade distally into the window 101 (the blade being connected to the plunger and moving with respect to the body of the device 100’).

[0027] Referring to FIGS. 6-8, another alternative embodiment of the device 100” is shown. This embodiment functions the same as the first embodiment described in relation to FIGS. 1-4, except a knob 600 is included (i.e., integrally formed or otherwise attached to or positioned) on the device 100” that serves to assist the user with keeping a suture that is attached to a graft in-line with the shaft / cutting blade to prevent excessive angling of the cut end while in use (by wrapping or otherwise capturing the suture by the knob or a hemisphere thereof). In a preferred embodiment, as shown in FIG. 7, the knob 600 is divided into two hemispheres 602 and 604, and the pathway provided by the hemispheres substantially aligns with the central axis of the device to ensure proper alignment. A cross sectioned view of the device 100” is shown in FIG. 8.

[0028] It should be understood that any of the specific dimensions recited in this application can apply to any embodiment described above. All embodiments can be combined in any way mechanically possible.

[0029] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the embodiments. As used herein, the singular forms “a”, “an”, and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as, “has” and “having”), “include” (and any form of include, such as “includes” and “including”), and “contain” (any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, a method or device that “comprises”, “has”, “includes” or “contains” one or more steps or elements. Likewise, a step of method or an element of a device that “comprises”, “has”, “includes” or “contains” one or more features possesses those one or more features but is not limited to possessing only those one or more features.722217730.V1-9 / 9 / 25Atorney Docket No. Cl 118 PCT 3Furthermore, a device or structure that is configured in a certain way is configured in at least that way but may also be configured in ways that are not listed.

[0030] The corresponding structures, materials, acts and equivalents of all means or step plus function elements in the claims below, if any, are intended to include any structure, material or act for performing the function in combination with other claimed elements as specifically claimed. The description of the present embodiments has been presented for purposes of illustration and description but is not intended to be exhaustive or limited to the embodiments in the form disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the embodiments. The embodiment was chosen and described in order to best explain the principles of one or more aspects of the embodiments and the practical application, and to enable others of ordinary skill in the art to understand one or more aspects of the present embodiments for various embodiments with various modifications as are suited to the particular use contemplated.822217730.V1-9 / 9 / 25

Claims

Atorney Docket No. Cl 118 PCT 3CLAIMSWhat is claimed is:

1. A surgical cutting device, comprising: an elongated body extending along a central longitudinal axis and having a proximal end and a distal end, the distal end having a top surface and a bottom surface; a window positioned through the top surface and the bottom surface of the distal end, at least one wall extending in a direction above the top surface of the distal end and adjacent to the window and forming a distal interior space with the distal end surface; and an elongated blade having a distal end positioned and moveable within the elongated body from a non-cutting position and configuration and to a cutting position and configuration within the window.

2. The surgical cutting device of claim 1, further comprising a handle portion extending from the proximal end of the elongated body.

3. The surgical cutting device of claim 2, wherein the handle portion is integrally formed with the elongated body.

4. The surgical cutting device of claim 2, further comprising an actuator pivotally connected to the handle portion and configured to move from a non-actuated position to an actuated position.

5. The surgical cutting device of claim 4, wherein when the actuator is in the non-actuated position, the elongated blade is in the non-cutting configuration.

6. The surgical cutting device of claim 4, wherein when the actuator is in the actuated position, the elongated blade is in the cutting configuration.

7. The surgical cutting device of claim 1, further comprising at least one guide positioned on the at least one wall.

8. The surgical cutting device of claim 1, further comprising a spring configured to bias the blade in the non-cutting configuration.

9. The surgical cutting device of claim 1 , wherein the top surface of the distal end is closer to the bottom surface of the elongated body than the top surface of the elongated body.

10. The surgical cutting device of claim 1, further comprising a raised surface positioned at the distal end of the elongated body.922217730.V1-9 / 9 / 25Atorney Docket No. Cl 118 PCT 311. The surgical cutting device of claim 10, wherein the raised surface is angled upward toward the distal end with respect to the central longitudinal axis.

12. A method of transecting a tissue, comprising the steps of: providing a surgical cutting device comprising: an elongated body extending along a central longitudinal axis and having a proximal end and a distal end, the distal end having a top surface and a bottom surface; a handle portion positioned at the proximal end of the elongated body and having an actuator configured to move from a first position to a second position; a window positioned through the top surface and the bottom surface of the distal end, at least one wall extending in a direction above the top surface of the distal end and adjacent to the window and forming a distal interior space with the distal end surface; and an elongated blade having a distal end positioned and moveable within the elongated body from a non-cutting configuration not within the window and to a cutting position and configuration within the window; positioning the tissue through the window; and cutting the tissue by moving the actuator from the first position to the second position.

13. The method of claim 12, wherein the handle portion is integrally formed with the elongated body.

14. The method of claim 12, wherein when the actuator is in the non-actuated position, the elongated blade is in the non-cutting configuration.

15. The method of claim 12, wherein when the actuator is in the actuated position, the elongated blade is in the cutting configuration.

16. The method of claim 12, wherein the surgical device further comprises at least one guide positioned on the at least one wall.

17. The method of claim 12, wherein the surgical device further comprises a spring configured to bias the blade in the non-cutting configuration.

18. The method of claim 12, wherein the top surface of the distal end is closer to the bottom surface of the elongated body than the top surface of the elongated body.

19. The method of claim 12, wherein the surgical device further comprises a raised surface positioned at the distal end of the elongated body.1022217730.V1-9 / 9 / 25Atorney Docket No. Cl 118 PCT 320. The method of claim 19, wherein the raised surface is angled upward toward the distal end with respect to the central longitudinal axis.1122217730.V1-9 / 9 / 25

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