Surgical tool and suture passing device and method

By employing a larger diameter wire to capture and pull a smaller diameter wire through bone bores using a capture element, the challenges of passing small diameter wires during surgical procedures are addressed, enhancing the efficiency of surgical operations like bunion repair.

WO2025052370A1PCT designated stage expired Publication Date: 2025-03-13BONFIX
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Patent Information

Application Number
PCT/IL2023/050941
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Filing Date
2023-09-04
Publication Date
2025-03-13

AI Technical Summary

Technical Problem

Existing surgical tools face difficulties in efficiently passing small diameter wires through drilled bores in bones, particularly during procedures like bunion repair, due to the challenges of using small diameter wires with drills.

Method used

The use of a larger diameter wire to drill through bones and capture a smaller diameter wire, allowing the smaller wire to be pulled through the bore using a capture element, such as a coil spring, which can be adjusted to grip and release the smaller wire.

Benefits of technology

This method enables efficient passage of small diameter wires through bone bores, facilitating procedures like bunion repair by simplifying the process of suture placement and manipulation within the bones.

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Abstract

A surgical tool and suture passing device and method provides a capture element on an elongated tool which may be inserted in a bore in a bone and which may be used to capture a second tool and pull it through the bore. The second tool may be attached to a suture using a specially configured suture passer to manipulate a suture in the bore. The system and method have wide surgical applicability, including in bunion repair.
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Description

SURGICAL TOOL AND SUTURE PASSING DEVICE AND METHODFIELD OF THE INVENTION

[0001] The present invention relates to a surgical device, system and method. More particularly, the present invention relates to a tool and suture catching device and a tool and suture catching and passing system useful in surgical environments, including orthopedic surgery.BACKGROUND OF THE INVENTION

[0002] It is known in the art, for example from U.S. Pat. No. 5,055,105, to provide a drill bit having means to hold a suture to a drill bit shank as the shank passes through a drilled hole, the shank having a wider section at the proximal end of the shank so that a trailing suture or other elongated element attached to the drill bit passes easily through the drilled bore. In some instances, however, it may be desired to pull a suture or other elongated element through a bore in a bone that has been drilled.

[0003] U.S. Pat. No. 9,138,223 teaches another drill pin for suture passing where the pin is provided with a wire loop or suture loop which attaches to a suture that may be threaded through a graft.

[0004] U.S. Pat. No. 8,425,554 describes a device used in bunion repair which includes a suture passing K-wire which has a portion or “guide pin” with a first diameter and terminating in a sharp tip and an adjacent second portion “behind” the guide pin in the direction of drilling and having a smaller diameter than the first diameter and terminating in an eyelet at the end opposite the sharp tip.

[0005] Devices and techniques for treating Hallux Abducto Valgus commonly associated with bunion deformity, as well as Hallux Varus are known from U.S. Pat. Nos. 9,345,514, 10,292,735 and 10,159,512 owned by the assignee herein.

[0006] All of the aforesaid U.S. Patents are incorporated by reference insofar as they teach elements known in the art.SUMMARY OF THE INVENTION

[0007] It has been discovered by the inventors herein that a small diameter wire used in a surgical procedure to pass a suture may be difficult to use with a drill, complicating bunion repair and potentially other surgeries. These difficulties may be avoided by drilling initially with a larger diameter wire and using the larger diameter wire to capture the small diameter wire and pass the small diameter through drilled bore(s) in the bones. A suture passing device may then be used to attach a suture to the smaller diameter wire to manipulate the suture in the bore.

[0008] A medical device suitable for use in these and other methods comprises: an elongated support configured to be passed through a bore in a bone; and a capture element attached at one end of the elongated support having an outside diameter adapted to be passed through the bore and an interior space adapted to receive and grasp a wire or implant having a smaller diameter than a diameter of the interior space of the capture element.

[0009] In embodiments, the capture element is a coil spring which has an internal diameter that is reduced when rotated to grip an opposing wire or tool.

[0010] In embodiments, the elongated support is a first Kirschner wire, or drill bit, adapted to be removed from the bore in the bone before completion of a surgical procedure; and the device further comprises a second tool attached to the first Kirschner wire, or drill bit, by the capture element.

[0011] In embodiments described herein in connection with orthopedic surgery, a method for fixing an elongated element between two or more bones may comprise: drilling bores in first and second bones and passing a first tool having a first diameter in a first direction through at least one of the bores; attaching a second tool having a second diameter smaller than the first diameter to the first tool with a capture element; adjusting the capture element to grip the first or second tool; pulling the second tool attached to the first tool by the capture element in a direction opposite the first direction through at least one of the bores; and releasing the grip of the capture element.

[0012] In embodiments, the capture element is a coil spring, and adjusting the capture element to grip the second tool consists of rotating the coil spring in one direction to reducethe inside diameter of the spring and releasing the grip consists of rotating the coil spring in the opposite direction to increase the inside diameter of the spring.

[0013] The capture element may be attached to the first tool and may be manipulated to grip the second tool having a smaller diameter. The capture element may also be attached to the smaller diameter tool and may be manipulated to grip the larger diameter tool, provided the outer diameter of the capture element is small enough to be pulled through at least one of the bores.

[0014] In embodiments, after the second tool is pulled through the bores, the method further comprises: providing a suture passer having a connector at a first end thereof adapted to receive the second tool in frictional engagement and an aperture at a second end thereof adapted to receive a suture; inserting the second-diameter wire into the connector of the suture passer so that the wire is frictionally engaged; and guiding a suture attached to the second end of the suture passer opposite the first end through at least one of the aligned bores in the first and second bones in a second direction opposite the first direction. (In embodiments, this is a direction from the first metatarsal toward the second metatarsal.) For example, the suture passaer may be provided with a tubular connector in which a tool can be inserted and frictionally engaged.

[0015] In embodiments described herein in connection with bunion repair, an elongated support (for example a 1.7 mm Kirschner wire (“K-wire”)) may be passed through aligned bores in two or more bones using a drill. A capture element attached at one end of the elongated support has an outside diameter that fits in the bore and an interior space adapted to receive and grasp an elongated member having a smaller diameter (for example, a 1.2 mm K- wire) which can then be pulled through the bore(s). The interior space of the capture element may be described as having a smaller diameter than a tool, wire, implant or anchor that the capture element grips if the capture element can be adjusted to have a smaller diameter. When a capture element is adjusted so that it tightly grips an elongated element, capture element applies a force on the gripped element and the interior diameter is of course equal to the diameter of the gripped element.

[0016] The wire having a capture element thereon may be provided separately or in a kit for performing methods according to the invention, the kit may include a suture passer having atubular connector at a first end thereof adapted to receive the second tool in frictional engagement and having an aperture at an end opposite the tubular connector configured for attachment to a suture.

[0017] In embodiments an implant or anchor is secured at one end of the suture, wherein an end of the suture opposite said implant or anchor is configured to be attached to an aperture in the suture passer. The second tool may then be used to manipulate the suture into place in the bore(s) by pulling the suture through the bore(s).BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In order for the present invention to be better understood and for its practical applications to be appreciated, the following Figures are provided and referenced hereinafter. It should be noted that the Figures are given as examples only and in no way limit the scope of the invention. Like components are denoted by like reference numerals.

[0019] FIG. 1 is schematic view of a surgical tool catching device according to embodiments of the invention.

[0020] FIG. 2 depicts passing a first tool having a capture element at one end thereof passed in a first direction through the bores using a drill and an aiming tool according to an embodiment of the invention.

[0021] FIG. 3 depicts a larger diameter wire positioned within aligned bores in adjacent bones with a capture element attached thereto and accessible on a lateral side of the second metatarsal according to embodiments of the invention.

[0022] FIG. 4 depicts a smaller diameter wire pulled through aligned bores in two bones by an attachment to a larger wire via a capture element.

[0023] FIG. 5 depicts a suture passing device according to embodiments of the invention.

[0024] FIG. 6 depicts drilling over a smaller diameter wire from the medial side of the first metatarsal using a step-down drill.

[0025] FIG. 7 depicts an embodiment of the invention wherein a capture element is provided on a smaller diameter wire and adapted to capture an element having a larger diameter.

[0026] FIG. 8 depicts an embodiment of the invention wherein a capture element on a first tool is adapted to grip an implant or anchor.DETAILED DESCRIPTION

[0027] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, it will be understood by those of ordinary skill in the art that the invention may be practiced without these specific details. In other instances, well-known methods, procedures, components, modules, units and / or circuits have not been described in detail so as not to obscure the invention.

[0028] Where surgical methods are described as a series of steps, the steps need not be performed in the stated order. A method may recite steps performed when a device is manufactured in addition to steps performed when the device is used in surgery, such as when a capture element is fixed to an elongated support.

[0029] The description refers to “wires,” which refers to any flexible elongated support. In specific embodiments, the wires may be Kirschner wires (hereinafter “K-wires”) but the term “wire” is not limited to such embodiments. A “surgical tool” as used herein is any device (including an elongated element adapted to be passed through a bore in a bone) that may be used to manipulate another object in a surgical environment. The description refers to first and second “tools,” which in embodiments may be wires or K-wires.

[0030] The device, systems and methods according to embodiments of the invention may be described in connection with a surgical technique for correction of bunion deformity in which an incision is made on the medial side of the first metatarsal followed by an incision on the lateral side of the second metatarsal. The bunion is thereafter shaved and the angle between the first and second metatarsal is corrected with a reduction clamp. An anchor is provided in the first metatarsal and a stabilizing element is installed between the first and second metatarsal secured by a second anchor in the second metatarsal. In the course of installing the stabilizing element between the first and second metatarsal, a drilling position on the second metatarsal is made with a marking and aiming tool for the entry point of a stabilizing pin (commonly, a K-wire). The tool is used to guide the drilling of a K-wire through the first and second metatarsals forming aligned bores in both bones.

[0031] In a subsequent step, drilling is performed from the medial side of the first metatarsal over the installed wire. For this step, a step down drill is used, adapted to form bores having different diameters in the first and second metatarsal, respectively. An anchor is thereafter introduced into the bore in the first metatarsal and a stabilizing element is installed between the two bones.

[0032] One aspect of the invention, in the context of the above-described surgical procedure, involves using a capture element on the first tool to grasp a smaller wire and pull the smaller wire through the aligned bores and then perform drilling with the step down drill over the smaller wire.

[0033] In embodiments, a device according to the invention comprises an elongated support configured to be passed through a bore in a bone. An elongated support may be a wire or a plastic tube that may be attached to a drill bit and having a diameter that allows the elongated support to pass through a bore formed by the drill bit. Supported or attached at one end of the elongated support is a capture element having a diameter adapted to receive a smaller- diameter second elongated member, wire or suture. Thus, in some cases, it may be desirable to manipulate a larger-diameter wire into place in a bore using a drill, for example, and then use the larger-diameter element to capture and pull a smaller-diameter wire through the bore.

[0034] In embodiments, the capture element is a coil spring which may be attached to the support element by crimping, ultrasonic welding, bonding or other method. A coil spring has an internal diameter that is reduced when rotated to grip the wire having the smaller diameter and may be rotated in the opposite direction to release the wire. Other mechanisms to capture the smaller-diameter member include, for example, a mesh which narrows as it is lengthened and pulled. A button click system may also be adapted to attach to the first tool to capture a smaller diameter tool.

[0035] In an embodiment of the invention depicted schematically in FIG. 1, one end of elongated element 20 having a first diameter (for example a 1.7 mm K-wire), may be provided with grasping element 22. In the embodiment shown, grasping element is a coil spring, which may be rotated to reduce its inside diameter and grip a second tool and rotated in the opposite direction to increase the inside diameter of the spring and release the second tool. Attachment of the grasping element to elongated element 20 may be made by any knownmethod, such as by crimping, ultrasonic welding or bonding. Grasping element 22 has an opening 28 configured to receive smaller diameter elongated element 24 (for example a 1.2 mm K-wire). Arrows 26 show rotation of second elongated element 24 to grip and release the grip of grasping element 22 around smaller diameter element 24. In the case of a coil spring, for example, rotating the spring in one direction may loosen an opening area 28 where a pointed end of a K-wire maybe inserted. Rotating the spring in an opposite direction may tighten spring 22 along its entire length around a portion of the smaller diameter element 24. A grasping element may be made of a mesh that tightens as it lengthens, or other securing mechanisms may be employed that attach such as by clipping or pinning the smaller diameter element in grasping element 22.

[0036] FIG. 2 depicts elongated element 20 installed through an aligned bore in two bones using an aiming and guiding tool 30 and drill 32. Referring to FIG. 3, once a bore is made, the drill may be detached, leaving a proximal grasping element 22 available to receive a smaller diameter elongated element 24. In FIG. 4, smaller diameter wire 24 is shown pulled through aligned bores in the bones in direction of arrow 40 by force applied to wire 20 and via grasping element 22.

[0037] In an embodiment depicted in FIG. 6, a step-down drill bit 62 may be used, drilling from the medial side, to create a larger bore over smaller diameter wire 24 in first metatarsal bone and a smaller bore in the second metatarsal leaving wire 24 in place. FIG. 5 depicts a suture passer 56 having aperture 52 at one end thereof which may attach to a surgical suture. An implant or anchor (not shown) may be attached to the suture and adapted to fit in a recess on the medial side of the first metatarsal. At an end of suture passer 56 opposite the aperture, a connector 54 may be provided adapted to receive the second tool in frictional engagement, for example using a conical and slightly resilient opening in a tubular connector 54. Once attached to the suture passer, wire 24 may be used to guide the suture and the attached implant or anchor into place. In another embodiment depicted schematically in FIG. 8, capture element 28 may grasp implant or anchor 29 which may then be guided into place with tool 20.

[0038] Different embodiments are disclosed herein. Features of certain embodiments may be combined with features of other embodiments; thus, certain embodiments may be combinations of features of multiple embodiments. The foregoing description of theembodiments of the invention has been presented for the purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. It should be appreciated by persons skilled in the art that many modifications, variations, substitutions, changes, and equivalents are possible in light of the above teaching. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the invention.

[0039] While certain features of the invention have been illustrated and described herein, many modifications, substitutions, changes, and equivalents will now occur to those of ordinary skill in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the invention.

Claims

What Is Claimed Is:

1. A method for fixing an elongated element between two or more bones, comprising: drilling bores in first and second bones and passing a first tool having a first diameter in a first direction through at least one of the bores; attaching a second tool having a second diameter smaller than the first diameter to the first tool with a capture element; adjusting the capture element to grip the first or second tool; pulling the second tool attached to the first tool by the capture element in a direction opposite the first direction through at least one of the bores; and adjusting the capture element to release the first or second tool.

2. The method according to claim 1, wherein the capture element is a coil spring, wherein adjusting the capture element to grip the first or second tool consists of rotating the coil spring to reduce the inside diameter of the spring, and adjusting the capture element to release the first or second tool consists of rotating the coil spring in an opposite direction to increase the inside diameter of the spring.

3. The method according to claim 1, wherein bores in the first and second bones are aligned, and wherein the second tool attached to the first tool by the capture element is pulled through the aligned first and second bores.

4. The method according to claim 1 , wherein the capture element is a coil spring attached to the first tool prior to drilling the first and second bores.

5. The method according to claim 3, further comprising: providing a suture passer having a connector at a first end thereof adapted to receive the second tool in frictional engagement and an aperture at a second end thereof adapted to receive a suture; inserting the second-diameter wire into the connector of the suture passer; and guiding a suture attached to the second end of the suture passer opposite the first end through at least one of the aligned bores in the first and second bones in a second direction opposite the first direction.

6. The method according to claim 5, further comprising: prior to guiding the suture through at least one of the aligned bores, attaching an implant or anchor to one end of the suture and attaching an end opposite said one end of the suture to an aperture in an end of the suture passer opposite the tubular connector and pulling the implant or anchor into a drilled recess in the first bone.

7. The method according to claim 3, wherein the first and second bones are the first and second metatarsal bones, respectively.

8. The method according to claim 7, wherein the method is an orthopedic procedure for correcting Hallux Abducto Valgus or Hallux Varus.

9. The method according to claim 8, wherein passing the first tool having a first diameter is performed by drilling using an aiming tool and a drill, and wherein the aiming tool and drill are removed from the first tool to leave the first tool installed in both aligned bores and the capture element outside the bore accessible on the lateral side of the second metatarsal bone.

10. The method according to claim 5, wherein the connector of the suture passer has a tubular end having a resilient surface adapted for frictional engagement with the second diameter wire.

11. A medical device, comprising: an elongated support configured to be passed through a bore in a bone; and a capture element attached at one end of the elongated support having an outside diameter adapted to be passed through the bore and an interior space of the capture element adapted to receive and grasp a wire, suture or implant having a smaller diameter than a diameter of the interior space of the capture element.

12. The medical device according to claim 11, wherein the capture element is a coil spring having an internal diameter that is reduced when rotated to grasp the wire or implant.

13. The medical device according to claim 12, wherein: the elongated support is a first Kirschner wire, or drill bit, adapted to be removed from the bore in the bone before completion of a surgical procedure; and wherein the device further comprises a second tool attached to the first Kirschner wire, or drill bit, by the capture element.

14. The medical device according to claim 13, wherein the second tool has a diameter smaller than a diameter of the first Kirschner wire or drill bit, and a coil spring attached to the first Kirschner wire or drill bit is adapted to be rotated to grip the second tool.

15. The medical device according to claim 11, wherein the elongated support is a first Kirschner wire configured to be drilled through aligned bores in a first metatarsal bone and a second metatarsal bone; further comprising a second Kirschner wire having a smaller diameter configured to be attached to the first Kirschner wire by rotating the coil spring, pulled through the bore with the first Kirschner wire and released from the first Kirschner wire by rotating the coil spring.

16. A suture passing and catching system, comprising: an elongated support configured to be drilled through a bore in a bone; a coil spring attached at one end of the elongated support having an outside diameter adapted to be passed through the bore and a variable inside diameter adapted to receive and grasp a second tool having a smaller diameter than a diameter of the elongated support when rotated; and a suture passer having a connector at a first end thereof adapted to receive the second tool in frictional engagement and having an aperture at an end opposite the tubular connector configured for attachment to a suture.

17. The suture passing and catching system according to claim 16, wherein the elongated support is a first K wire adapted to be drilled through aligned bores in two or more bones and the coil spring has an outside diameter adapted to pass through the aligned bores; the second tool having a smaller diameter is a K wire configured to pass through the aligned bores in the two or more bones and to be secured therein.

18. The suture passing and catching system according to claim 16, further comprising a suture having an anchor secured to an end thereof, wherein an end of the suture opposite said anchoris configured to be attached to an aperture in the suture passer to be guided into place in one of the aligned bores by pulling the suture with the suture passer.

19. The suture passing and catching system according to claim 17, further comprising a drill and alignment device for aligning the drill with the bores in the two or more bones.

20. The suture passing and catching system according to claim 17, wherein the system is provided as a kit for surgical correction of Hallux Abducto Vagus or Hallux Varus.

21. The suture passing and catching system according to claim 15, wherein the connector of the suture passer has a tubular end having a resilient surface adapted for frictional engagement with the second tool.

Citation Information

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