WO2015178928A1

WO2015178928A1 - Combination knot pusher and suture cutter with indexing blade

Info

Publication number: WO2015178928A1
Application number: PCT/US2014/039364
Authority: WO
Inventors: Graham Smith
Original assignee: Smith & Nephew, Inc.
Priority date: 2014-05-23
Filing date: 2014-05-23
Publication date: 2015-11-26

Abstract

Described herein are combination knot pusher and suture cutter systems 100 having a restricted opening for pushing a throw of a knot in a suture 109 and also having an indexing blade 113 for presenting a sharp, unused portion of the blade after each cut.

Description

COMBINATION KNOT PUSHER AND SUTURE CUTTER WITH

INDEXING BLADE

BACKGROUND

1. Field of the Invention

[0001] The present invention relates generally to surgical devices and more particularly to a combination knot pusher and suture cutter.

2. Discussion of Background Information

[0002] Many surgical procedures require the use of one or more sutures to secure bone and/or tissue to other bone and/or tissue. Such procedures generally require the operating surgeon to tie the suture(s) at some point during the procedure. In many such procedures, particularly in arthroscopic procedures, the suture(s) must be tied outside of the patient' s body and then the knot must be pushed into the repair site. In such procedures, the knot is made by tying a throw in the suture(s), pushing the throw into the repair site, and, if desired, tying and pushing one or more additional throws into the repair site. Subsequently, the surgeon must cut the free ends of the tied suture(s). This process of pushing and cutting requires two different instruments. First, pushing the one or more throws to tie the knot is achieved by use of a knot pusher. The knot pusher must then be removed and a suture cutter is used to sever the free ends of the tied suture(s).

[0003] Available suture cutters offer a single, fixed blade which must often be used to cut multiple sutures. The use of high strength polyester sutures in surgical procedures, particularly in arthroscopic rotator cuff repair surgery, causes these suture cutter blades to dull quickly. The dulling increases the force required to cut subsequent sutures and also frays the cut end(s) of the suture(s). In extreme cases, the cutter may fail to cut a suture entirely, requiring the surgeon to unwrap, prepare, and use an additional suture cutter.

SUMMARY OF THE INVENTION

[0004] It would be desirable to provide a combination knot pusher and suture cutter to reduce the number of instruments, thereby simplifying the procedure and reducing operating time. It would also be desirable to provide such combination knot pusher and suture cutters wherein an indexing blade is provided for presenting a sharp, unused portion of the blade for cutting, thereby avoiding the dulling associated with fixed blades.

[0005] Described herein are devices and techniques for solving the problems, such as increased operative time, increased cost, and the increased number of required instruments associated with performing surgery using separate knot pushers and suture cutters. The devices and techniques described herein also solve the problems, such as excessive dulling, frayed sutures, and increased cost associated with using fixed blade suture cutters. Examples of the combination knot pusher and suture cutter with indexing blade, hereinafter combination pusher/cutter, described herein include an inner sleeve having an aperture for receiving a suture and/or pushing a knot, an outer sleeve having a cutting edge, a handle having a trigger, and an indexing member, coupled to the trigger and the outer sleeve, wherein actuating the trigger causes the cutting edge to cut a suture in the aperture and causes the indexing member to index the blade.

[0006] In one aspect, at least one embodiment described herein provides a surgical device. The surgical device includes a handle with a trigger. The surgical device also includes an inner shaft extending from a proximal end of the handle, the inner shaft including an aperture defined by a surface of the inner shaft, wherein the aperture is sized to receive a suture. The surgical device also includes an outer sleeve rotatable about the inner shaft, the outer sleeve having a distal end positioned outside of the handle and a proximal end positioned within the handle. The surgical device also includes a cutting edge circumferentially disposed at the distal end of the outer sleeve, the cutting edge having a plurality of portions of which a first portion is exposed to cut a suture in the aperture. The surgical device also includes an indexing member coupled to the trigger and the proximal end of the outer sleeve for rotating the outer sleeve about the inner shaft by a fixed rotational angle for each trigger compression and/or release to expose a second portion of the cutting edge.

[0007] Any of the aspects and/or embodiments described herein can include one or more of the following embodiments. In some embodiments, the outer sleeve is slidable along a longitudinal axis of the surgical device relative to the inner shaft. In some embodiments, the indexing member is configured to slide the outer sleeve relative to the inner shaft for each trigger compression and/or release. In some embodiments, the cutting edge is positioned proximal to the aperture of the inner shaft upon the outer sleeve being slid proximally relative to the inner shaft by the indexing member and the cutting edge is positioned distal to the aperture upon the outer sleeve being slid distally relative to the inner shaft by the indexing member. In some embodiments, a hollow receiving member disposed at a distal end of the inner shaft, the hollow receiving member including an open end and a pathway connecting the open end with the aperture of the inner shaft. In some embodiments, the open end is sized to receive a free end of the suture and to prevent a throw of a knot formed in the suture from passing through.

[0008] In some embodiments, the indexing member includes an actuating pawl having a plurality of teeth disposed on a distal end of the actuating pawl and on a proximal end of the actuating pawl. In some embodiments, the indexing member includes a distal gear affixed to the outer sleeve and positioned to engage the teeth of the distal end of the actuating pawl when the outer sleeve is being slid distally by the indexing member. In some embodiments, the indexing member includes a proximal gear affixed to the outer sleeve and positioned to engage the teeth of the proximal end of the actuating pawl when the outer sleeve is being slid proximally by the indexing member.

[0009] In one aspect, at least one embodiment described herein provides a method for using a surgical device. The method includes tying a throw in a suture. The method also includes threading a free end of the suture through an aperture in an inner shaft of a surgical device, wherein the aperture is sized to accept the free end of the suture and prevent the throw from passing through. The method also includes pushing the throw along at least a portion of a length of the suture by sliding the surgical device relative to the suture. The method also includes actuating a trigger of the surgical device to slide a first portion of a cutting edge of an outer sleeve of the surgical device distally over the aperture and into severing contact with the suture. The method also includes actuating an indexing member coupled to the trigger to rotate the outer sleeve about the inner shaft by a fixed rotational angle to expose a second portion of the cutting edge.

[0010] Any of the aspects and/or embodiments described herein can include one or more of the following embodiments. In some embodiments, actuating the trigger simultaneously actuates the indexing member. In some embodiments, the method includes removing the suture from the surgical device. In some embodiments, the method includes tying a second throw in the suture. In some embodiments, the method includes rethreading the free end of the suture through the aperture in the inner shaft of the surgical device, wherein the aperture is sized to accept the rethreaded free end of the suture and prevent the second throw from passing through. In some embodiments, the method includes pushing the second throw along at least a portion of a length of the suture by sliding the surgical device relative to the suture.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] One will better understand these and other features, aspects, and advantages of the present invention following a review of the description, appended claims, and accompanying drawings: [0012] FIG. 1A is a perspective view of a combination pusher/cutter in accordance with various embodiments.

[0013] FIG. IB is a side view of the combination pusher/cutter of FIG. 1 A in accordance with various embodiments.

[0014] FIG. 1C is a cross-sectional side view of the suture anchor of Fig. 1A in accordance with various embodiments.

[0015] FIG. 2A is a perspective view of a distal end of a combination pusher/ cutter having a suture pusher portion in accordance with various embodiments.

[0016] FIG. 2B is a perspective view of a combination pusher/cutter severing a suture in accordance with various embodiments.

[0017] FIG. 2C is a perspective view of a combination pusher/cutter having an indexed blade in accordance with various embodiments.

[0018] FIGS. 3A-3B are perspective views of an indexing member in a trigger compression position and a trigger release position, respectively, in accordance with various embodiments.

[0019] FIG. 3C is a cross-sectional side view of an indexing member in a trigger release position in accordance with various embodiments.

[0020] FIG. 4 is a flow chart illustrating a method for using a combination pusher/cutter in accordance with various embodiments.

DETAILED DESCRIPTION

[0021] Figs. 1A-1C illustrate an example of a combination knot pusher and suture cutter with indexing blade, hereinafter combination pusher/cutter, 100 having a handle 101, a trigger 103, an inner shaft 105 having an aperture 107 for receiving one or more sutures 109, an outer sleeve 111, a cutting edge 113, a receiving member 115, and an indexing member 117. A surgeon ties a throw (e.g., throw 205 as shown in FIGS. 2A-2C) in the suture(s) 109 and feeds the free end (e.g., free end(s) 203 as shown in FIG. 2 A) through an open end 119 of the receiving member 115 and out through the aperture 107. The throw is then drawn against the open end 119, which is sized to prevent the throw from passing. The surgeon then pushes the throw toward a repair site in the patient by sliding the combination pusher/cutter 100 relative to the suture so that the open end 119 pushes the throw. If additional throws are needed to complete the desired knot, the surgeon can remove the suture 109 from the combination pusher/cutter 100, tie an additional throw, and repeat the process described above. When the final throw has been pushed into place, the surgeon keeps the combination pusher/cutter 100 in place and compresses the trigger 103, thereby driving the cutting edge 113 into severing contact with the free end of the suture 109. Compression and/or release of the trigger 103 also causes the indexing member 117 to rotate the outer sleeve 111 by a fixed rotational angle relative to the inner shaft 105 so that an unused portion of the cutting edge 113 is exposed for any required cutting of additional sutures 109. The trigger 103, in accordance with various embodiments, is returned to a released state by an optional return element 121 (e.g., a spring as shown in FIG. 1C).

[0022] Handle 101 can be a single piece or, as shown in FIGS. 1A-1C, the handle 101 can include multiple pieces. The handle 101 shown in FIGS. 1A-1C includes the handle 101 as well as a proximal end 101a for fixing the inner shaft 105 in the handle 101 and a distal end 101b for retaining the outer sleeve 111 and the inner shaft 105 in concentric alignment along a longitudinal axis of the combination pusher/cutter 100. The handle 101, in accordance with various embodiments, can be designed for a user's ergonomic comfort and can be constructed of any suitable material including, for example but not limited to, plastics, polymers (e.g., PVC, PEEK), composites (e.g., carbon fiber, Kevlar, fiberglass), metals (e.g., titanium, surgical steel), wood, and/or any other suitable material. The handle can be formed by any suitable process including, for example but not limited to, molding, vacuum forming, machining, rapid prototyping, and/or any other suitable process.

[0023] The handle 101, in accordance with various embodiments, is coupled to the trigger 103 (e.g., hingedly attached as shown in FIG. 3B). Actuation of the trigger 103 operates the indexing member 117 as described in further detail below. [0024] The inner shaft 105 is fixed at one end to the proximal end 101a of the handle 101 and extends through the handle 101 and outward from the distal end 101b of the handle 101. The inner shaft 105 can be solid or hollow and can be constructed of any suitable material including, for example but not limited to, plastics, polymers (e.g., PVC, PEEK), composites (e.g., carbon fiber, Kevlar, fiberglass), metals (e.g., titanium, surgical steel), wood, and/or any other suitable material. A surface of the inner shaft 105 defines the aperture 107, wherein the aperture 107 is sized to receive the suture 109.

[0025] As best shown in FIGS. 1 A, 2A, and 2C, the receiving member 115 is disposed at a distal end of the inner shaft 105 and includes the open end 119 sized to receive the free end 203 of one or more of the suture(s) 109 and prevent the throw 205 from passing through. The receiving member also includes an inner pathway which connects the receiving member 115 with the aperture 107, allowing the free end 203 of the suture(s) 109 to pass through the open end 119 and out the aperture 107 where, as described in greater detail below, the cutting edge 113 of the outer sleeve 111 can be driven into severing contact with the suture 109 in the aperture 107.

[0026] Outer sleeve 111 is a hollow elongate body which is rotatable about the inner shaft 105. The outer sleeve 111 includes a distal end positioned outside of the handle 101 and a proximal end positioned within the handle 101. The outer sleeve 111 can be constructed of any suitable material including, for example but not limited to, plastics, polymers (e.g., PVC, PEEK), composites (e.g., carbon fiber, Kevlar, fiberglass), metals (e.g., titanium, surgical steel), wood, and/or any other suitable material.

[0027] In addition to being rotatable about the inner shaft 105, the outer sleeve 111 is also slidable along a longitudinal axis of the combination pusher/cutter 100 relative to the inner shaft 105. The cutting edge 113 is disposed around a

circumference of the distal end of the outer sleeve 111. Therefore, sliding of the outer sleeve 111 relative to the inner shaft 105 (e.g., when driven by indexing member 117) can, in accordance with various embodiments, drive the cutting edge 113 into severing contact with the suture 109 as shown in FIG. 2B.

[0028] As best shown in FIGS. 3A-3C, the indexing member 117 (e.g., indexing mechanism 300) is operatively coupled to the trigger 103 and to the proximal end of the outer sleeve 111. It will be apparent in view of this disclosure that any suitable indexing mechanism (e.g., an electronic motor with electronic controls and/or a ratchet and pawl mechanism as shown) can be used to rotate or otherwise index the outer sleeve 111 and, by extension, the cutting edge 113 or blade. As shown and described herein, the indexing member 117 serves the dual purpose of driving the cutting edge 113 into severing contact with the suture 109 and of indexing the cutting edge 113. However, it will be apparent in view of this disclosure that, in accordance with various embodiments, the indexing member 117 can be used for the sole purpose of indexing the cutting edge 113 and a second mechanism and/or trigger can be used for driving the cutting edge 113 into severing contact with the suture 109.

[0029] Indexing member 117 can, in accordance with various embodiments, include an indexing mechanism. FIGS. 3A-3C illustrate an exemplary indexing mechanism 300 in accordance with various embodiments. The indexing mechanism 300 includes an actuating pawl 301 coupled to the trigger 103 and distally and proximally slidable relative to the outer sleeve 111. The actuating pawl 301, in accordance with various embodiments, includes drive flanges 305 for engagement with one or more drive elements 307 of the trigger 103. As shown in FIG. 3A, when the trigger 103 is compressed, the drive elements 307 drive the flanges 305 and the actuating pawl 301 distally into engagement with a distal gear 309 affixed to the outer sleeve 111 and then further distally driving the distal gear 309. Because the distal gear 309 is affixed to the outer sleeve 111, distally driving the distal gear 309 also drives the outer sleeve 111 and the cutting edge 113 distally relative to the inner shaft 105 and into severing contact with the suture 109. As shown in FIG. 3B, when the trigger 103 is released, the drive elements 307 drive the flanges 305 and, thereby, the actuating pawl 301 proximally into engagement with a proximal gear 311. As shown in FIG. 3C, in accordance with various embodiments, the return element 121 (e.g., a spring as shown), upon trigger 103 release, drives the actuating pawl 301 proximally into engagement with the proximal gear.

[0030] The actuating pawl 301 also includes a plurality of distal pawl teeth 313 disposed on a distal end of the actuating pawl 301 and a plurality of proximal pawl teeth 315 on a proximal end of the actuating pawl 301.

[0031] The distal pawl teeth 313 of the actuating pawl 301 are positioned to engage the distal gear teeth 314 of the distal gear 309 when the trigger 103 is compressed. The proximal pawl teeth 315 of the actuating pawl 301 are positioned to engage the proximal gear teeth 316 of the proximal gear 311 when the trigger 103 is released.

[0032] The distal and proximal pawl teeth 313, 315 and distal and proximal gear teeth 314, 316 are mirrored so that, whether the actuating pawl 301 engages the distal or proximal gears 309, 311, the outer sleeve 111 and, by extension, the cutting edge 113 are rotated (indexed) in a common direction by a fixed rotational angle.

[0033] An indexing mechanism 300 as shown in FIGS. 3A-3C, in accordance with various embodiments, partially indexes the cutting edge 113 upon compression of the trigger 103 when the actuating pawl 301 engages the distal gear 309 and partially indexes the cutting edge 113 upon release of the trigger 103 when the actuating pawl 301 engages the proximal gear 311.

[0034] Indexing cutting edge 113 about the inner shaft 105 by a fixed rotational angle for each trigger 103 compression and/or release in this manner aligns a different part of the circumferential blade with the aperture 107 of the inner shaft 105. As shown in FIG. 2C, this indexing advantageously exposes an unused, sharp portion 207 of the cutting edge for cutting another suture 109 and rotates the used, duller portion 209 away from the aperture 107.

[0035] In accordance with various embodiments, the distal and proximal pawl teeth 313, 315 and distal and proximal gear teeth 314, 316 can be of any suitable design or shape. In accordance with various embodiments, any of the actuating pawl 301, distal gear 309, proximal gear 311, flanges 305, drive elements 307, the trigger, 103, and/or any of the teeth 313, 314, 315, 316 can be constructed of any suitable material including, for example but not limited to, plastics, polymers (e.g., PVC, PEEK), composites (e.g., carbon fiber, Kevlar, fiberglass), metals (e.g., titanium, surgical steel), wood, and/or any other suitable material.

[0036] It will be apparent in view of this disclosure that, while depicted as a compression/release trigger 103, trigger 103 can be of any suitable configuration including, for example but not limited to, a compression/release trigger (e.g., as shown), a slidable trigger, and/or an activation button for an electronic indexing member.

[0037] FIG. 4, illustrates a method 400 for using a combination pusher/cutter in accordance with various embodiments. The method includes tying 401 a throw in a suture, threading 403 a free end of the suture through a aperture in an inner shaft of a combination pusher/cutter, wherein the aperture is sized to accept the free end of the suture and prevent the throw from passing through, pushing 405 the throw along at least a portion of a length of the suture by sliding the combination pusher/cutter relative to the suture, actuating a trigger 407 of the combination pusher/cutter to drive a first portion of a cutting edge of an outer sleeve of the combination pusher/cutter distally over the aperture and into severing contact with the suture, and actuating an indexing member 409 coupled to the trigger to rotate the outer sleeve about the inner shaft by a fixed rotational angle to expose a second portion of the cutting edge for cutting another suture.

[0038] The step of tying 401 can, in accordance with various embodiments, include, for example but not limited to, tying the throw 205 in the suture 109 as described with reference to FIGS. 1A-2B above.

[0039] The step of threading 403 can, in accordance with various embodiments, include, for example but not limited to, feeding the free end 203 of the suture 109 through the open end 119 of the receiving member 115 and through the aperture 107 as described with reference to FIGS. 1 A-2C above. [0040] The step of pushing 405 can, in accordance with various embodiments, include, for example but not limited to, pushing the throw 205 by sliding the combination pusher/cutter 100 relative to the suture 109 as described with reference to FIGS. 1A-2C above.

[0041] The step of actuating a trigger 407 can, in accordance with various embodiments, include, for example but not limited to, compressing the trigger 103, thereby driving the cutting edge 113 into severing contact with the suture 109 as described with reference to FIGS. 2A-3C above.

[0042] The step of actuating an indexing member 409 can, in accordance with various embodiments, include, for example but not limited to, compressing the trigger 103 to engage the actuating pawl 301 with the distal gear 309 and/or the proximal gear 311, thereby rotating the cutting edge 113 to expose an unused, sharp portion 301 of the cutting edge for cutting another suture 109 and rotating the used, duller portion 303 away from the aperture 107 as described with reference to FIGS. 2A-3C above.

[0043] It is noted that the foregoing examples have been provided merely for the purpose of explanation and are in no way to be construed as limiting of the present invention. While the present invention has been described with reference to an exemplary embodiment, it is understood that the words, which have been used herein, are words of description and illustration, rather than words of limitation. Changes may be made, within the purview of the appended claims, as presently stated and as amended, without departing from the scope and spirit of the present invention in its aspects. Although the present invention has been described herein with reference to particular means, materials and embodiments, the present invention is not intended to be limited to the particulars disclosed herein; rather, the present invention extends to all functionally equivalent structures, methods and uses, such as are within the scope of the appended claims.

Claims

CLAIMS What is claimed is:

1. A surgical device comprising:

a handle with a trigger;

an inner shaft extending from a proximal end of the handle, the inner shaft including an aperture defined by a surface of the inner shaft, wherein the aperture is sized to receive a suture;

an outer sleeve rotatable about the inner shaft, the outer sleeve having a distal end positioned outside of the handle and a proximal end positioned within the handle;

a cutting edge circumferentially disposed at the distal end of the outer sleeve, the cutting edge having a plurality of portions of which a first portion is exposed to cut a suture in the aperture; and

an indexing member coupled to the trigger and the proximal end of the outer sleeve for rotating the outer sleeve about the inner shaft by a fixed rotational angle for each trigger compression and/or release to expose a second portion of the cutting edge.

2. The surgical device of Claim 1, wherein the outer sleeve is slidable along a longitudinal axis of the surgical device relative to the inner shaft and, wherein the indexing member is configured to slide the outer sleeve relative to the inner shaft for each trigger compression and/or release.

3. The surgical device of Claim 2, wherein the cutting edge is positioned proximal to the aperture of the inner shaft upon the outer sleeve being slid proximally relative to the inner shaft by the indexing member and the cutting edge is positioned distal to the aperture upon the outer sleeve being slid distally relative to the inner shaft by the indexing member.

4. The surgical device of Claim 1, further comprising a hollow receiving member disposed at a distal end of the inner shaft, the hollow receiving member including an open end and a pathway connecting the open end with the aperture of the inner shaft.

5. The surgical device of Claim 4, wherein the open end is sized to receive a free end of the suture and to prevent a throw of a knot formed in the suture from passing through.

6. The surgical device of Claim 2, wherein the indexing member comprises:

an actuating pawl having a plurality of teeth disposed on a distal end of the actuating pawl and on a proximal end of the actuating pawl;

a distal gear affixed to the outer sleeve and positioned to engage the teeth of the distal end of the actuating pawl when the outer sleeve is being slid distally by the indexing member; and

a proximal gear affixed to the outer sleeve and positioned to engage the teeth of the proximal end of the actuating pawl when the outer sleeve is being slid proximally by the indexing member.

7. A method for using a surgical device comprising the steps of:

tying a throw in a suture;

threading a free end of the suture through an aperture in an inner shaft of a surgical device, wherein the aperture is sized to accept the free end of the suture and prevent the throw from passing through; pushing the throw along at least a portion of a length of the suture by sliding the surgical device relative to the suture;

actuating a trigger of the surgical device to slide a first portion of a cutting edge of an outer sleeve of the surgical device distally over the aperture and into severing contact with the suture; and

actuating an indexing member coupled to the trigger to rotate the outer sleeve about the inner shaft by a fixed rotational angle to expose a second portion of the cutting edge.

8. The method of Claim 7, wherein actuating the trigger simultaneously actuates the indexing member.

9. The method of Claim 7, further comprising:

removing the suture from the surgical device;

tying a second throw in the suture;

rethreading the free end of the suture through the aperture in the inner shaft of the surgical device, wherein the aperture is sized to accept the

re threaded free end of the suture and prevent the second throw from passing through; and

pushing the second throw along at least a portion of a length of the suture by sliding the surgical device relative to the suture.