WO2024044201A1

WO2024044201A1 - Orthopedic wire implantation system

Info

Publication number: WO2024044201A1
Application number: PCT/US2023/030845
Authority: WO
Inventors: Charles R. Bennett; Nicholas S. Ritchey; Haden JANDA; Adam ZYSK
Original assignee: Smith & Nephew, Inc.; Smith & Nephew Orthopaedics Ag; Smith & Nephew Asia Pacific Ptd. Limited
Priority date: 2022-08-23
Filing date: 2023-08-22
Publication date: 2024-02-29

Abstract

Disclosed herein is an implantation device for an orthopedic cerclage wire. The implantation device may include a hollow body having a curved or hooked end configured to be arranged around a target bone region, such as a portion of a shaft of a femur. An implantation cable configured as a flat, flexible ribbon-like elongated member may be operative to be extended out of the body to encircle the target bone region. The implantation cable may be configured to form a loop having a predetermined radius or radius range when extended outside of the body. A shuttle may be coupled to an end of the implantation cable that travels around the bone when extended. The shuttle may be connected to a cerclage wire to push or pull the cerclage wire around the bone when the implantation cable is extended or retracted.

Description

ORTHOPEDIC WIRE IMPLANTATION SYSTEM

CROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63/400,216, filed August 23, 2022, and titled “Orthopedic Wire Implantation System,” the entire contents of which application is hereby incorporated by reference in its entirety.

TECHNICAL FIELD

[0002] The present disclosure is directed to orthopedic implants for stabilizing one or more portions of a bone, and more specifically, to a cabling system used in orthopedic fixation.

BACKGROUND

[0003] Bone fractures are often repaired by securing an orthopedic device to one or more patient bones, such as a bone fastener or screw, plates, implants, and/or the like. For long bone fractures, such orthopedic devices may not be a viable option or may require fracture stabilization before being installed. Accordingly, a wire or other extendable structure (for instance, a cerclage wire) may be used to stabilize the fracture and/or as final fixation when other orthopedic devices may be ineffective. [0004] When implanting a cerclage wire, an incision is made at or near a portion of the fracture and a cable or cerclage wire passer is inserted through the incision. Conventional passers are typically formed of one or more rigid tubes or channels, generally formed into the shape of a hook, extending from a handle. During an installation or cabling procedure, the hook is inserted into the surgical site and the passer is manipulated within the patient until the hook is arranged around the bone, for instance, a shaft of a femur. A surgeon may then feed a cerclage wire into one end of the passer (e.g., at an end of the handle opposite the hook, facing away from the incision), through the tube arranged around the bone, through an open end in the tube, and out of the patient via the incision. The passer may then be manipulated to remove the passer from around the bone and the cerclage wire and passer are separated, leaving the cerclage wire behind, encircling the bone. The surgeon may tension the cerclage wire to secure it to the bone, thereby forming a cable-based “clamp” around the fractured bone.

[0005] Although there are risks throughout a cabling procedure, manipulation of the passer to position the hook around the bone is generally the most difficult step with the highest risk of error. Conventional passers are challenging to manipulate correctly and reliably and require extensive operator expertise to achieve placement at a target site and to avoid causing further patient injury. Even when operated correctly, conventional passer devices are prone to causing damage to tissue surrounding the bone. Accordingly, cerclage wires are an effective tool for fracture stabilization; however, implantation of cerclage wires with accurate placement and minimizing patient injury using conventional passer devices has proved problematic.

[0006] Accordingly, there remains a need for an improved cerclage wire passer device. It is with this in mind that the present disclosure is provided.

SUMMARY

[0007] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter.

[0008] The present disclosure describes an implantation or passer (terms used interchangeably herein without the intent to limit) device for implanting a cable, wire, cerclage wire, fixation wire, or orthopedic wire (terms used interchangeably herein without the intent to limit) around the bone of a patient. The implantation device may be configured for full cerclage wiring of a bone, for example, a 360-degree circumferential placement of a cerclage wire around a bone at a fracture site. A nonlimiting example of a bone may include a femur, for instance, the shaft portion of a femur. Although a femur may be used in examples of implantation procedures using an implantation device in the present disclosure, examples are not so limited, as implantation devices configured according to some examples may be used to implant cerclage wires around various other patient bone anatomy.

[0009] In any preceding or subsequent examples, an implantation device may include a body configured to house an implantation cable operative to push or pull a cerclage wire around a bone of a patient.

[0010] In any preceding or subsequent examples, an implantation device may include an at least partially hollow body having a distal or implantation end, configured to be implanted within a patient at least partially around a portion of a bone, and a proximal or handle end opposite the distal end. In general, and without the intent to limit, the term “distal” may refer to an end of the implantation device that is closer to a target bone when implanted within a patient and the term “proximal” may refer to an end of the implantation device that is closer to an operator of the implantation device. In any preceding or subsequent examples, the body of the implantation device may be configured as a hooked or curved cannula or tube.

[0011] In any preceding or subsequent examples, an implantation cable may be arranged within the body. A proximal or handle end of the implantation cable may be coupled to an extension structure. The extension structure may be configured to be pushed within the body toward the bone to extend the implantation cable outside of an opening at the distal end of the body, and to be pulled within the body toward the proximal end of the body to retract the implantation cable into the body. In any preceding or subsequent examples, the extension structure may include a handle and/or a shaft coupled to the proximal end of the implantation cable. In any preceding or subsequent examples, the extension structure may be, may include, or may be operated by an electric, motorized, computer-implemented, or otherwise automated extension/retraction system.

[0012] In any preceding or subsequent examples, the implantation cable may be configured to encircle or loop around the bone when extended out of the distal end of the body. In any preceding or subsequent examples, the implantation cable may be formed of a memory material. In any preceding or subsequent examples, the implantation cable may be formed of a memory material configured to form a loop having a predetermined radius or radius range when extended outside of the body. The radius or radius range may be configured to correspond to the outer diameter of the bone.

[0013] In any preceding or subsequent examples, the implantation cable may be formed of various materials, including, without limitation a shape memory material (SMM), a shape memory alloy (SMA), future developed SMMs and SMAs, nickel (Ni), titanium (Ti), copper (Cu), zinc (Zn), aluminum (Al), Ni-Ti materials, nitinol, Cu-Zn-Al materials, Cu-Al-Ni materials, mixtures thereof, alloys thereof, and/or the like. In any preceding or subsequent examples, the implantation cable may be formed of nitinol or a material that contains nitinol. In any preceding or subsequent examples, the implantation cable may not be formed of a memory material. In any preceding or subsequent examples, the implantation cable may be formed of a metal material, a polymer material, a fibrous material, and/or combinations thereof.

[0014] In any preceding or subsequent examples, the implantation cable may be a flat or substantially flat structure. In any preceding or subsequent examples, for instance, the implantation cable may have a rectangular cross section, for instance, with a flat, ribbon- or band-like shape. In any preceding or subsequent examples, the implantation cable may have a width of about 0.5 mm, about 0.75 mm, about 1.0 mm, about 1.25 mm, about 1.5 mm, about 1.75 mm, about 2.0 mm, about 3.0 mm, about 5.0 mm, and any value or range between any two of these values (including endpoints).

[0015] In any preceding or subsequent examples, a distal end of the implantation cable may be coupled to a shuttle. In any preceding or subsequent examples, the implantation cable may be releasably coupled to the shuttle. Non-limiting examples of releasable connections may include a magnetic connection, a trigger lock/release connection, snap-fit connection, a gear-based connection, a release pin-or rod-based connection, and/or the like. In any preceding or subsequent examples, the implantation device may be configured to pull or push the shuttle in a path around the bone as the implantation device is retracted or extended into/out of the body. [0016] In any preceding or subsequent examples, the shuttle may be formed of various materials, including, without limitation, metals, polymers, magnets, and/or the like. In any preceding or subsequent examples, the shuttle may have a length and/or width of about 0.25 mm, about 0.5 mm, about 1 mm, about 1.5 mm, about 2.0 mm, about 3.0 mm, about 5.0 mm, and any value or range between any two of these values (including endpoints). In any preceding or subsequent examples, the shuttle may have one or more shapes, including, without limitation, a square or substantially square shape, a rectangular or substantially rectangular shape, a round or substantially round shape, a triangular or substantially triangular shape, combinations thereof, variations thereof, and/or the like.

[0017] In any preceding or subsequent examples, a face of the shuttle may have a shape and/or elements configured to facilitate movement of the shuttle within the patient and around the bone. In any preceding or subsequent examples, the face may be or may have elements that are angled, pointed, faceted, and/or sharp to pierce or cut through tissue (for instance, the linea aspera attached to the femur). In any preceding or subsequent examples, the face may be or may have elements that are rounded, beveled, square, angled, pointed, protruding, faceted, sharp, curved, straight, combinations thereof, and/or the like. In any preceding or subsequent examples, the shuttle may be a leading edge of the implantation device moving within the patient. In any preceding or subsequent examples, the shuttle may be integral in the function of positioning the implantation device around the bone.

[0018] In any preceding or subsequent examples, a cerclage wire may be arranged in or on a component of an implantation device. In any preceding or subsequent examples, the cerclage wire may be formed of various materials, including metal materials, polymer materials, fibrous materials, bio-compatible materials, and/or the like. In any preceding or subsequent examples, the cerclage wire may be a flexible, monofilament structure.

[0019] In any preceding or subsequent examples, the implantation device may be configured to operate in a “push” or “pull” mode. In a push mode, for instance, the implantation cable may pull the cerclage wire around the bone as the implantation cable extends around the bone responsive to pushing the shaft within the body. In a pull mode, for instance, the implantation cable may be extended around the bone responsive to pushing the shaft within the body toward the bone without the cerclage wire being attached to the shuttle, then the shuttle may be attached to the cerclage wire. The implantation cable and/or shuttle may pull the cerclage wire around the bone when the implantation cable is retracted back into the body via pulling the shaft out of the body in a direction away from the bone.

[0020] In any preceding or subsequent examples, the implantation device may include a locking mechanism. In any preceding or subsequent examples, the locking mechanism may be or may include a button, toggle, and/or the like that may be actuated to cause a locking element (e.g., a locking pin or other elongated structure) to engage a portion of the shuttle to couple the shuttle to the body after the shuttle has encircled the bone (i.e., maintaining the implantation cable in a loop around the bone). In any preceding or subsequent examples, the locking element may be or may include a magnet configured to attach the shuttle to the body. In any preceding or subsequent examples, the locking element may be or may include a pin or rod that may engage a corresponding portion (e.g., a slot, ridge, groove, and/or the like) of the shuttle to hold the shuttle at the body after the shuttle has encircled the bone. [0021] In any preceding or subsequent examples, a push implantation process may be performed using an implantation device configured according to some examples. In any preceding or subsequent examples, the push implantation process may include inserting an implantation end of a body of the implantation device into an incision of a patient adjacent to a target bone portion, with a curved implantation end of the body arranged around the target bone portion. The implantation device may include a shuttle coupled to an implantation cable and a cerclage wire. A handle may be coupled to a handle end of the implantation wire. The handle may be pushed into the body, toward the bone, to extend the implantation cable out of an implantation end of the body. The implantation cable may extend and form a loop around the target bone portion, thereby pushing the shuttle and the cerclage wire to travel around the target bone portion. The shuttle may be coupled to the body and the implantation cable may be released from the shuttle and retracted back into the body. The implantation device may be manipulated out of the body of the patient, leaving the cerclage wire encircling the target bone portion.

[0022] In any preceding or subsequent examples, a pull implantation process may be performed using an implantation device configured according to some examples. In any preceding or subsequent examples, the pull implantation process may include inserting an implantation end of a body of the implantation device into an incision of a patient adjacent to a target bone portion, with a curved implantation end of the body arranged around the target bone portion. The implantation device may include a shuttle coupled to an implantation cable. A handle may be coupled to a handle end of the implantation wire. The handle may be pushed into the body, toward the bone, to extend the implantation cable out of an implantation end of the body. The implantation cable may extend and form a loop around the target bone portion, thereby pushing the shuttle to travel around the target bone portion. The shuttle may be coupled to the body. The implantation device may include a cerclage wire that may be coupled to the shuttle when the implantation cable has traveled around the target bone portion and the shuttle is arranged at the body. The implantation cable may be retracted back into the body, thereby causing the shuttle to travel back around the bone to the implantation end of the body. The cerclage wire, due to the attachment to the shuttle, is pulled around the bone. When the shuttle arrives at the implantation end of the body, the cerclage wire at least partially encircles the target bone portion. The implantation device may be manipulated out of the body of the patient, leaving the cerclage wire encircling the target bone portion.

[0023] In any preceding or subsequent examples, an insertion tool for wrapping an orthopedic cable around a bone may include a tool body having an insertion end portion and a slot; a push-pull means that is slidably assembled in the tool body; a memory loop having a proximal end portion and a distal end portion, the proximal end portion affixed to the push-pull means, the memory loop may include a shuttle at the distal end portion, the shuttle may be adapted to receive the orthopedic cable, wherein the memory loop is a memory-shaped, metal tape that curves to a pre-defined radius of curvature when unconstrained; and a locking mechanism connected to the memory loop, the locking mechanism having a knob that partially extends through the tool body slot; wherein the memory loop may be selectively manipulable by the push- pull means to extend from an insertion end of the tool body and wrap around the bone and to retract back into the tool body, and wherein the locking mechanism is selectively operable to temporarily constrain the memory loop in a fixed position. [0024] In any preceding or subsequent examples, a surgical method may include providing an insertion tool for wrapping an orthopedic cable around a bone; connecting the orthopedic cable to a memory loop located on the insertion tool; making an incision; inserting an insertion end portion of the insertion tool through the incision; advancing push-pull means to advance the memory loop with a portion of the cable around the bone; operating a locking mechanism to temporarily constrain the memory loop; withdrawing the push pull means; and securing the orthopedic cable to the bone.

[0025] Examples of the present disclosure provide numerous technological features and advantages over conventional cerclage wire passer devices and cerclage wire implantation techniques. In one non-limiting technological advantage, an implantation device according to some examples may reduce an amount of implantation device manipulation within the patient, compared to conventional devices, which may lead to a reduction in the surgical incision required for an implantation process. For instance, an implantation device according to some examples may require little to no manipulation to get the body of the implantation device (e.g., the hook of the implantation device) inserted within tissue and around the target bone area.

Accordingly, an implantation process using an implantation device according to some examples may utilize minimally invasive surgical techniques to implant a cerclage wire around a target bone area.

[0026] In another non-limiting technological advantage, an implantation device according to some examples may lead to reduced damage to tissue surrounding the target bone area when achieving cerclage wire implantation. In an additional nonlimiting technological advantage, an implantation device according to some examples may provide for more reliable and accurate cerclage wire implantation. In an additional non-limiting technological advantage, an implantation device according to some examples may allow for an implantation procedure that is less complex and error prone compared with conventional techniques, allowing surgeons to implant cerclage wires with reduced risk for error and without requiring extensive experience, in a manner that is safer for patients and that leads to improved patient outcomes.

[0027] In any preceding or subsequent examples, a cerclage wire implantation device may include a body having an implantation end and a hollow portion; an implantation cable at least partially arranged within the hollow portion; a shuttle coupled to a shuttle end of the implantation cable, the shuttle end arranged at the implantation end of the body; a cerclage wire; and a handle coupled to a handle end of the implantation cable, the handle end arranged opposite the shuttle end.

[0028] In any preceding or subsequent examples of the cerclage wire implantation device, the implantation end may be configured to be positioned within an incision of a patient and adjacent to a bone of the patient.

[0029] In any preceding or subsequent examples of the cerclage wire implantation device, the implantation end may include a curved or hooked shape configured to be positioned around at least a portion of the bone.

[0030] In any preceding or subsequent examples of the cerclage wire implantation device, the shuttle end of the implantation cable may be configured to form a loop having a predetermined radius.

[0031] In any preceding or subsequent examples of the cerclage wire implantation device, the handle may be configured to be pushed toward the insertion end of the body to cause the implantation cable to extend out of an opening at the implantation end of the body and around the bone.

[0032] In any preceding or subsequent examples of the cerclage wire implantation device, movement of the implantation cable may be configured to cause corresponding movement of the shuttle around the bone.

[0033] In any preceding or subsequent examples of the cerclage wire implantation device, the shuttle may include a face shaped to cut through tissue to facilitate movement of the shuttle around the bone.

[0034] In any preceding or subsequent examples of the cerclage wire implantation device, the cerclage wire may be coupled to the shuttle.

[0035] In any preceding or subsequent examples of the cerclage wire implantation device, the shuttle may be configured to push the cerclage wire around the bone as the shuttle travels around the bone.

[0036] In any preceding or subsequent examples of the cerclage wire implantation device, the implantation device may further include a locking mechanism configured to couple the shuttle to the body after the shuttle has encircled the bone and exited the incision.

[0037] In any preceding or subsequent examples of the cerclage wire implantation device, the implantation cable may be configured to be released from the shuttle, when the shuttle is coupled to the body, and retracted within the body.

[0038] In any preceding or subsequent examples of the cerclage wire implantation device, the cerclage wire may be coupled to the body. [0039] In any preceding or subsequent examples of the cerclage wire implantation device, the shuttle may be configured to be coupled to the cerclage wire after the shuttle has encircled the bone and exited the incision.

[0040] In any preceding or subsequent examples of the cerclage wire implantation device, the implantation cable may be configured to be retracted within the body, pulling the shuttle and the cerclage wire coupled to the shuttle around the bone, wherein at least a portion of the cerclage wire encircles the bone when the implantation cable is fully retracted within the body.

[0041] In any preceding or subsequent examples of the cerclage wire implantation device, the body may be configured to be removed from the patient via the incision, wherein the cerclage wire is retained around the bone.

[0042] In any preceding or subsequent examples of the cerclage wire implantation device, the handle may be coupled to the cerclage wire via an extension structure. [0043] In any preceding or subsequent examples of the cerclage wire implantation device, the handle may be configured to be pulled in a retraction direction away from the extension end of the body to retract the implantation cable, at least partially, within the body, and pushed in an extension direction toward the implantation end of the body to extend, at least partially, the implantation cable outside of the body. [0044] In any preceding or subsequent examples of the cerclage wire implantation device, the implantation cable may be formed of a memory material.

[0045] In any preceding or subsequent examples of the cerclage wire implantation device, the memory material may include at least one of a shape memory material (SMM), a shape memory alloy (SMA), nickel (Ni), titanium (Ti), copper (Cu), zinc (Zn), aluminum (Al), Ni-Ti materials, nitinol, Cu-Zn-Al materials, or Cu-Al-Ni materials.

[0046] In any preceding or subsequent examples of the cerclage wire implantation device, the implantation cable may have a flat or substantially flat shape.

[0047] In any preceding or subsequent examples of the cerclage wire implantation device, the shuttle may be releasably coupled to the implantation cable.

[0048] In any preceding or subsequent examples of the cerclage wire implantation device, the bone may include a shaft of a femur.

[0049] In any preceding or subsequent examples, a push method of implanting a cerclage wire around a bone of a patient, the method may include inserting an implantation end of a body of an implantation device into an incision in the patient and adjacent to the bone, the implantation device including: an implantation cable at least partially arranged within the body, a shuttle coupled to a shuttle end of the implantation cable, the shuttle end arranged at the implantation end of the body, a cerclage wire coupled to the shuttle, and a handle coupled to a handle end of the implantation cable, the handle end arranged opposite the shuttle end; and pushing the handle toward the implantation end to cause the implantation cable to extend out of an opening at the implantation end of the body and to move with the shuttle around the bone, the shuttle configured to push the cerclage wire around the bone as the shuttle travels around the bone.

[0050] In any preceding or subsequent examples of the push method, the implantation end may have a curved or hooked shape configured to be positioned around at least a portion of the bone. [0051] In any preceding or subsequent examples of the push method, the shuttle end of the implantation cable may be configured to form a loop having a predetermined radius.

[0052] In any preceding or subsequent examples of the push method, the shuttle may have a face shaped to cut through tissue to facilitate movement of the shuttle around the bone.

[0053] In any preceding or subsequent examples of the push method, the method may further include coupling the shuttle to the body, via a locking mechanism, after the shuttle has encircled the bone and exited the incision.

[0054] In any preceding or subsequent examples of the push method, the method may further include releasing the implantation cable from the shuttle, when the shuttle is coupled to the body, thereby retracting the implantation cable within the body.

[0055] In any preceding or subsequent examples of the push method, the method may further include removing the body from the patient via the incision, wherein the cerclage wire is retained around the bone.

[0056] In any preceding or subsequent examples of the push method, the handle may be coupled to the cerclage wire via an extension structure.

[0057] In any preceding or subsequent examples of the push method, the handle may be configured to be pulled in a retraction direction away from the extension end of the body to retract the implantation cable, at least partially, within the body, and pushed in an extension direction toward the implantation end of the body to extend, at least partially, the implantation cable outside of the body.

[0058] In any preceding or subsequent examples of the push method, the implantation cable may be formed of a memory material. [0059] In any preceding or subsequent examples of the push method, the memory material may include at least one of a shape memory material (SMM), a shape memory alloy (SMA), nickel (Ni), titanium (Ti), copper (Cu), zinc (Zn), aluminum (Al), Ni-Ti materials, nitinol, Cu-Zn-Al materials, or Cu-Al-Ni materials.

[0060] In any preceding or subsequent examples of the push method, the implantation cable may have a flat or substantially flat shape.

[0061] In any preceding or subsequent examples of the push method, the shuttle releasably may be coupled to the implantation cable.

[0062] In any preceding or subsequent examples of the push method, the bone may include a shaft of a femur.

[0063] In any preceding or subsequent examples, a pull method of implanting a cerclage wire around a bone of a patient may include inserting an implantation end of a body of an implantation device into an incision in the patient and adjacent to the bone, the implantation device including: an implantation cable at least partially arranged within the body, a shuttle coupled to a shuttle end of the implantation cable, the shuttle end arranged at the implantation end of the body, a cerclage wire coupled to the body, and a handle coupled to a handle end of the implantation cable, the handle end arranged opposite the shuttle end; pushing the handle toward the implantation end to cause the implantation cable to extend out of an opening at the implantation end of the body and to move with the shuttle around the bone, out of the incision, and to couple to the cerclage wire; and retracting the implantation cable within the body, pulling the shuttle and the cerclage wire coupled to the shuttle around the bone, wherein at least a portion of the cerclage wire encircles the bone when the implantation cable is fully retracted within the body. [0064] In any preceding or subsequent examples of the pull method, the implantation end may have a curved or hooked shape configured to be positioned around at least a portion of the bone.

[0065] In any preceding or subsequent examples of the pull method, the shuttle end of the implantation cable may be configured to form a loop having a predetermined radius.

[0066] In any preceding or subsequent examples of the pull method, the shuttle may have a face shaped to cut through tissue to facilitate movement of the shuttle around the bone.

[0067] In any preceding or subsequent examples of the pull method, the method may further include removing the body from the patient via the incision, wherein the cerclage wire is retained around the bone.

[0068] In any preceding or subsequent examples of the pull method, the handle may be coupled to the cerclage wire via an extension structure.

[0069] In any preceding or subsequent examples of the pull method, the handle may be configured to be pulled in a retraction direction away from the extension end of the body to retract the implantation cable, at least partially, within the body, and pushed in an extension direction toward the implantation end of the body to extend, at least partially, the implantation cable outside of the body.

[0070] In any preceding or subsequent examples of the pull method, the implantation cable may be formed of a memory material.

[0071] In any preceding or subsequent examples of the pull method, the memory material may include at least one of a shape memory material (SMM), a shape memory alloy (SMA), nickel (Ni), titanium (Ti), copper (Cu), zinc (Zn), aluminum (Al), Ni-Ti materials, nitinol, Cu-Zn-Al materials, or Cu-Al-Ni materials.

[0072] In any preceding or subsequent examples of the pull method, the implantation cable may have a flat or substantially flat shape.

[0073] In any preceding or subsequent examples of the pull method, the shuttle may be releasably coupled to the implantation cable.

[0074] In any preceding or subsequent examples of the pull method, the bone may include a shaft of a femur.

[0075] Examples are not limited in this context. Additional technological advantages and technical features over conventional systems would be known to those of skill in the art based on the present disclosure.

[0076] Further features and advantages of at least some of the examples of the present disclosure, as well as the structure and operation of various examples, are described in detail below with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0077] By way of example, illustrative examples of the disclosed device will now be described, with reference to the accompanying drawings, in which:

[0078] FIGS. 1A-1D depict an implantation process using a first illustrative example of an implantation device in accordance with the present disclosure;

[0079] FIGS. 2A-2D depict an implantation process using a second illustrative example of an implantation device in accordance with the present disclosure;

[0080] FIG. 3A depicts a side view of a third illustrative example of an implantation device in accordance with the present disclosure; [0081] FIG. 3B depicts a top-down view of the illustrative example of an implantation device shown in FIG. 3A in accordance with the present disclosure;

[0082] FIG. 3C depicts a perspective view from a handle end of the illustrative example of an implantation device shown in FIG. 3A in accordance with the present disclosure;

[0083] FIG. 3D depicts a perspective view from an implantation end of the illustrative example of an implantation device shown in FIG. 3A in accordance with the present disclosure;

[0084] FIGS. 4A and 4B depict exploded views of the illustrative example of an implantation device shown in FIG. 3A in accordance with the present disclosure; and [0085] FIGS. 4C-4G depict views of components of the illustrative example of an implantation device shown in FIG. 3A in accordance with the present disclosure.

[0086] It should be understood that the drawings are not necessarily to scale and that the disclosed examples are sometimes illustrated diagrammatically and in partial views. In certain instances, details which are not necessary for an understanding of the disclosed methods and devices, or which render other details difficult to perceive may have been omitted. It should be further understood that this disclosure is not limited to the particular examples illustrated herein. In the drawings, like numbers refer to like elements throughout unless otherwise noted.

DETAILED DESCRIPTION

[0087] Various features of an improved cerclage wire implantation or passer device will now be described more fully hereinafter with reference to the accompanying drawings, in which one or more features of the implantation device will be shown and described. It should be appreciated that the various features may be used independent of, or in combination, with each other. It will be appreciated that an implantation device as disclosed herein may be embodied in many different forms and should not be construed as being limited to the examples set forth herein. Rather, these examples are provided so that this disclosure will convey certain features of the implantation device to those skilled in the art.

[0088] Disclosed herein are various implantation systems including one or more features arranged and configured to enable securement of a wire, a cable, an orthopedic cable, cerclage wire, or the like (terms used interchangeably herein without the intent to limit), for instance, via a cable clamp system where a cerclage wire is used in a stand-alone procedure or via a cable assembly where a cerclage cable is used in combination with an orthopedic implant such as, for example, a bone fastener and/or plate.

[0089] FIGS. 1A-1D depict an implantation process using a first illustrative example of an implantation device in accordance with the present disclosure. As shown in FIG.

1 A, a cerclage wire implantation device 100 may include a hollow or partially hollow body 110 having a first, proximal, or handle end 111 and a second, distal, or implantation end 113. With respect to implantation device 100 and the use thereof, the term “distal” may refer to an end of implantation device 100 that is closer to a target bone 120 when implanted within a patient and the term “proximal” may refer to an end of implantation device 100 that is closer to an operator of implantation device 100 when implanted within a patient. In some examples, body 110 may be configured as a hooked or curved cannula or tube that may be inserted into a patient and arranged, at least partially, around a portion of a patient bone. [0090] According to some examples, body 100 may have various dimensions, including a length, diameter, and/or the like. In various examples, the dimensions of body 100 may be dependent on one or more factors, including, without limitation, the size and/or length of a cerclage wire 102, implantation cable 104, and/or any accessory devices necessary for implantation which must pass through body 100. In some examples, body 100 may have a length of about at least 6 inches. In various examples, body 100 may have a length of about 4 inches, about 5 inches, about 6 inches, about 7 inches, about 8 inches, 10 inches, greater than about 10 inches, or any value or range between any two of these values (including endpoints). In various examples, body 100 may have a diameter of about 0.75 inches. In some examples, body 100 may have a diameter of less than about 0.5 inches, about 0.5 inches, about 0.75 inches, about 1.0 inches, about 2.0 inches, greater than about 2.0 inches, or any value or range between any two of these values (including endpoints).

[0091] During a cerclage wire implantation process, an incision 124 may be made at or near a fracture site of bone 120 targeted for cerclage wire implantation. In some examples, bone 120 may include a femur, for instance, a shaft portion of a femur. Implantation end 113 may be inserted through incision 124 and manipulated around bone 120. FIGS. 1A-1D depict implantation device 100 after installation of implantation device 100 around bone.

[0092] In some examples, body 110 may be curved or have a hook shape. For example, at least a portion of implantation end 113 may include a curved, hooked, or convex portion shaped to correspond to an outer diameter of bone 120. In some examples, implantation end 113 may be configured to partially encircle bone 120. For example, implantation end 113 may be configured to encircle about 0 mm (e.g., no portion of bone is encircled), less than about 3 mm, about 3 mm, about 5 mm, about 7 mm, about 10 mm, about 12 mm, about 15 mm, about 20 mm, about 40 mm, greater than about 40 mm, and any value or range between any two of these values (including endpoints) of the circumference of bone 120. In another example, implantation end 113 may be configured to encircle about 10 percent, about 15 percent, about 20 percent, about 25 percent, about 33 percent, about 50 percent, about 75 percent, and any value or range between any two of these values (including endpoints) of the circumference of bone 120.

[0093] In some examples, body 110 may not have a curved or hooked end. In various examples, body 110 may not encircle a portion of bone 120 (e.g., body 110 may be placed adjacent to bone 120 and implantation cable 104 and/or cerclage wire 102 may encircle bone 120 without having a portion of body 110 encircling bone).

[0094] Implantation device 100 may include a handle 114 coupled to a shaft 112. Handle 114 may be configured to push/pull shaft 112 in/out of body 110 through handle opening 115 in body 110. Shaft 112 may be a rigid or substantially rigid structure coupled to a handle end 103 of an implantation cable, loop, ribbon, ligament, strip, band, elongated element, and/or the like (terms used interchangeably herein without the intent to limit) 104. A shuttle end 105 of implantation cable 104 may be coupled to a shuttle 106. In some examples, implantation cable 104 may be releasably coupled to shuttle 106 (see, for example, FIG. ID).

[0095] Referring to FIG. IB, pushing shaft 112 via handle 114 within body 110 toward bone 120 may cause implantation cable 104 to extend out of body 110 via opening 119. The extension of implantation cable 104 may push shuttle 106 around bone 120. The use of handle 114 and shaft 112 to push implantation cable 104 out of body 110 and around bone 120, as depicted in FIGS. 1A-1D, is for illustrative purposes. For instance, movement of implantation cable 104 may be facilitated or augmented by various other manual and/or automated techniques.

[0096] In some examples, implantation cable 104 may be configured to form a loop around or otherwise encircle at least a portion of bone 120 when extended out of body 110 (and not constrained by the inner walls of body 110). In various examples, implantation cable 104 may be formed of a memory material configured to form a loop having a predetermined radius or radius range when extended outside of body 110. The radius or radius range may be configured to correspond to the outer diameter of bone 120.

[0097] Implantation cable 104 may be formed of various materials, including, without limitation a shape memory material (SMM), a shape memory alloy (SMA), future developed SMMs and SMAs, nickel (Ni), titanium (Ti), copper (Cu), zinc (Zn), aluminum (Al), Ni-Ti materials, nitinol, Cu-Zn-Al materials, Cu-Al-Ni materials, mixtures thereof, alloys thereof, and/or the like. In some examples, implantation cable 104 may be formed of nitinol or a material that contains nitinol.

[0098] In some examples, implantation cable 104 may be a flat or substantially flat structure (see, for example, FIG. 3D). In various examples, implantation cable 104 may have a flat, ribbon- or band-like shape. In some examples, implantation cable 104 may have a width of about 0.5 mm, about 0.75 mm, about 1.0 mm, about 1.25 mm, about 1.5 mm, about 1.75 mm, about 2.0 mm, about 3.0 mm, about 5.0 mm, about 6 mm, greater than about 6 mm, and any value or range between any two of these values (including endpoints). In some examples, implantation cable 104 may have a width of about 3 mm to about 6 mm. In various examples, a width of implantation cable 104 may be based, at least in part, on patient anatomy dimensions, for example, smaller bone radii may allow for smaller implantation cable 104 widths.

[0099] Conventional loop-based passer devices typically include loops formed of tubular or cylindrical structures. Such loop structures are generally unreliable because that do not follow a direct path around a bone (for instance, they may veer off in unintended directions as the loop is being extended around the bone), leading to injury of tissue adjacent to the bone and/or erroneous implantation of cerclage wires that are not located at the correct target site. Accordingly, implantation cable 104 according to some examples may have a ribbon or ribbon-like shape, for instance, a flat and (relatively) wide shape, particularly compared to conventional loop-based passer devices. In addition, implantation cable 104 may be coupled to shuttle 106 that is configured to provide for reliable travel of implantation cable 104 (and cerclage wire 102) that reduces or even eliminates damage (or unintended damage) to tissue surrounding bone 120.

[0100] Referring to FIG. 1C, in various examples, implantation cable 104 may extend around bone 120 (thereby pushing shuttle 106 around bone in a same or similar path) and shuttle 106 may engage a shuttle engagement structure 151 of body 110. In some examples, for example, shuttle engagement structure 151 may include an opening in body 110 and shuttle 106 may extend at least partially through the opening. In various examples, for example, shuttle engagement structure 151 may include an element, such as a flange, clip, protrusion, recess, cavity, and/or the like configured to engage a portion of shuttle 106. In some examples, for example, shuttle engagement structure 151 may include a flange and shuttle 106 may include a corresponding protrusion configured to engage the flange to couple shuttle 106 to body 110 (i.e., maintaining implantation cable 104 in a loop around bone 120). In various examples, for example, shuttle engagement structure 151 may include a magnet system configured to magnetically hold shuttle 106 to/within/on/etc. body 110.

[0101] In some examples, body 110 may include a shuttle guiding structure 152 configured to guide shuttle 106 for at least a portion of the path around bone 120 to body 110. In various examples, for example, shuttle guiding structure 152 may be or may include a magnet configured to attract shuttle 106 to body 110. In some examples, shuttle guiding structure 152 may be a part of or coupled to shuttle, for instance, a magnet configured to attract shuttle to body 110. In some examples, for example, shuttle guiding structure 152 may only guide shuttle 106 as it nears body 110, for example, to ensure shuttle 106 couples properly to body 110.

[0102] Referring to FIG. 1C, implantation device 100 may include a locking mechanism. In some examples, locking mechanism 130 may be a button, toggle, and/or the like that may be actuated to cause a locking element 121 (e.g., a locking pin or other elongated structure) to engage a portion of shuttle 106 to hold shuttle 106 to or at a locking area of body 110 (i.e., maintaining implantation cable 104 in a loop around bone 120). For example, referring to FIGS. 1A-1C, shaft 112 may be pushed into body 110 toward bone 120, causing implantation cable 104 to extend out of body 110 and to loop around bone 120. Shuttle 106 may enter opening 137 and locking mechanism 130 may be actuated (for instance, depressed or depressed and moved toward bone 120) to cause locking element 121 to engage implantation cable 104 and hold implantation cable 104 to the locking area of body 110, thereby holding implantation cable 104 in a loop around bone 120. [0103] A cerclage wire 102 may be arranged in or on a component of implantation device 100. Cerclage wire 102 may be formed of various materials, including metal materials, polymer materials, and/or the like. In some examples, cerclage wire 102 may be a flexible, monofilament structure.

[0104] Implantation device 100 may be configured to operate in a “push” or “pull” mode. In a push mode (for example, see, FIGS. 1A-1D), for instance, implantation cable 104 may pull cerclage wire 102 around bone 120 as implantation cable 104 extends around bone 120 responsive to pushing shaft 112 within body 110. In a pull mode (see, for example, FIGS. 2A-2D), for instance, implantation cable 104 may be extended around bone 120 responsive to pushing shaft 112 within body 110 toward bone 120 without cerclage wire 102 being attached to shuttle 106, then shuttle 106 may be attached to cerclage wire 102 and may pull cerclage wire 102 around bone 120 when implantation cable 104 is retracted back into body 110 via pulling shaft 112 out of body 110 in a direction away from bone 120.

[0105] In some examples, implantation cable 104 may be releasably coupled to shuttle 106. In various examples, implantation cable 104 may be coupled to shuttle 106 via various techniques such that implantation cable 104 may be released from shuttle 106. Non-limiting examples of releasable connections may include a magnetic connection, a trigger lock/release connection, a snap-fit connection, a gear-based connection, a release pin-or rod-based connection, and/or the like. In various examples, multiple types of releasable connections and/or components thereof may be used in combination. For instance, a release pin-or rod-based connection may be used with magnetic connection components. [0106] In some examples, for example, a cable detachment actuator 131 may be actuated to release implantation cable 104 from shuttle 106. In various examples, for example, locking element 121 (or other rod or pin) may operate to release implantation cable 104 from shuttle 106 via actuation of locking mechanism 130 (or other actuator). Although locking mechanism 130 and detachment actuator 131 are depicted as separate elements in FIGS. 1A-1D, the associated functionality may be performed by a single element.

[0107] Referring to FIG. 1A, in a push implantation process, a shuttle end 141 of cerclage wire 102 may be attached to shuttle 106 prior to placement of body 110 through incision 124 and the arrangement of implantation end 113 around bone 120. A free end 142 of cerclage wire 102 may remain outside of the patient. In some examples, cerclage wire 102 may be releasably attached to shuttle 106. In various examples, cerclage wire 102 may be permanently or non-releasably attached to shuttle 106 (e.g., requiring cutting or other manual removal by an operator). In various examples, cerclage wire 102 may be arranged on an outside of body 110. In various examples, at least a portion of cerclage wire 102 may be arranged within body 110. [0108] As shown in FIG. IB, as shuttle 106 is pushed around bone 120 via implantation cable 104, cerclage wire 102 is pushed around bone 120 via shuttle 106. Referring to FIG. ID, implantation cable 104 may be released from shuttle 106 and retracted back into body 110, leaving cerclage wire 102 around bone 120. Removal of implantation device 100 from the patient may cause only cerclage wire 102 to remain encircled around bone 120, with ends 141 and 142 outside of the patient for the final configuration or implantation steps of cerclage wire 102 (e.g., removal from implantation device 100, tensioning, tightening, twisting/tying/etc., attachment of devices (plates, screws, anchors, etc.), and/or the like). In some examples, after removal of implantation device 100 from the patient, shuttle 106 may be disengaged from body 110.

[0109] In some examples, a face 143 of shuttle 106 (and/or a leading edge of implantation end 113) may have a shape and/or elements configured to facilitate movement of implantation end 113 within the patient and around bone 120. In some examples, face 143 may be or may have elements that are configured to pierce or cut through tissue (for instance, the linea aspera attached to the femur). In various examples, for instance, face 143 may be or may have elements that are rounded, beveled, square, angled, pointed, protruding, faceted, sharp, curved, straight, combinations thereof, and/or the like. In some examples, shuttle 106 may be a leading edge of implantation device 100 moving within the patient. In various examples, shuttle 106 may be integral in the function of positioning implantation device 110 around bone 120.

[0110] In some examples, shuttle 106 and/or face 143 may be shaped to facilitate shuttle 106 taking a path around bone 120 during extension. For example, extension of implantation cable 104 outside of the body of the patient may cause implantation cable 104 (and therefore shuttle 106) to extend in a (non-looped) straight or substantially straight path. In various examples, shuttle 106 and/or face 143 may be shaped such that as implantation cable 104 is extended within the body of the patient, adjacent to bone 120, shuttle 106 and/or face 143 may cause shuttle 106 to follow a path around bone 120 to encircle bone (for instance, due to contact of shuttle 106 and/or face 143 with tissue surrounding bone 120 and/or due to memory material properties of implantation cable 104). [0111] Shuttle 106 may be formed of various materials, including metals, polymers, magnets, and/or the like described according to some examples in the present disclosure. In some examples, shuttle 106 may have a length, width, and/or height of about 0.25 mm, about 0.5 mm, about 1 mm, about 1.5 mm, about 2.0 mm, about 3.0 mm, about 5.0 mm, and any value or range between any two of these values (including endpoints). In various examples, shuttle 106 may have a width the same or substantially the same as a width of implantation cable 104. In various examples, shuttle 106 may have a width of about 3 mm. In some examples, shuttle 106 may have a length of about 5 mm. In various examples, shuttle 106 may have a height of about 5 nun.

[0112] In various examples, shuttle 106 may have one or more shapes, including, without limitation, a square or substantially square shape, a rectangular or substantially rectangular shape, a round or substantially round shape, a triangular or substantially triangular shape, a bullet or substantially bullet shape, combinations thereof, variations thereof, and/or the like.

[0113] Although FIGS. 1A-1D depict a pushing implantation process operating using shuttle 106 to push cerclage wire 102 around bone 120, examples are not so limited, as cerclage wire 102 may be implanted around bone 120 via direct attachment to implantation cable 104 without the use of shuttle 106. Accordingly, in some examples, a shuttle may not be used. In various examples, a cerclage wire may be directly coupled/de-coupled from an implantation cable the same or similar as described for a shuttle in the present disclosure.

[0114] FIGS. 2A-2D depict an implantation process using a second illustrative example of an implantation device in accordance with the present disclosure. In some examples, FIGS. 2A-2D depict an implantation device 200 that may be configured for a “pull” implantation process.

[0115] As shown in FIG. 2A, an implantation device 200 may include a body 210 having an implantation cable 204 arranged therein. Implantation cable 204 may be coupled to a shuttle 206 on a first end and a shaft or handle 212 on an opposite end. Implantation device 200 may be inserted within an incision 224 in a limb 222 of patient and arranged around a bone 220, such as a femur. In some examples, shuttle 206 may include a sharp or pointed leading edge 245 configured to facilitate movement of implantation device 200 and shuttle 206 through tissue surrounding bone 220.

[0116] In various examples, implantation device 200 may include a cerclage wire 202. In various examples, at least a portion of cerclage wire 202 may be arranged within body 210. In some examples, cerclage wire 202 may be arranged outside of body 210. Cerclage wire 202 may have a coupling element 235 arranged at a shuttle end 241. In some examples, coupling element 235 may be configured to couple cerclage wire 202 to shuttle 206. In various examples, shuttle 206 may have a coupling element 237 that corresponds to coupling element 235 of cerclage wire 202. In various examples, only cerclage wire 202 has a coupling element 235. In some examples, only shuttle 206 has a coupling element 237. Non-limiting examples of coupling elements 235 and/or 237 may include magnets, flanges, protrusions, grooves, slots, tabs, hooks, and/or the like. In some examples, for example, coupling element 235 and/or 237 may include a magnet that may be coupled to a corresponding coupling element (such as a magnet) and/or directly to shuttle 206 (for coupling element 235) or cerclage wire (for coupling element 237). In various examples, for example, coupling element 235 (or shuttle end 241) may be configured to engage coupling element 237, such as a slot, groove, and/or the like, which receives coupling element 235 (or shuttle end 241) and holds cerclage wire 202 to shuttle 206.

[0117] In some examples, cerclage wire 202 may be manufactured with an integrated coupling element 235 such that a user may cut integrated coupling element 235 off of cerclage wire 202 prior to final tensioning.

[0118] Referring to FIG. 2B, shaft 212 may be pushed into body 210 toward bone 220, causing implantation cable 204 to extend out of body 210. Implantation cable 204 may be configured to loop around bone 220 when extended out of body 210. For example, implantation cable 204 may be formed of a memory material configured to form a loop of a predetermined radius to encircle bone 220. In another example, implantation cable 204 may engage (and/or cut through) tissue surrounding bone 220 causing implantation cable 204 to follow a path to encircle bone 220. As implantation cable 204 extends out of body 210, implantation cable 204 pushes shuttle 206 around bone 220. Shuttle 206 engages and is coupled to cerclage wire 202, for instance, via shuttle end 241 and/or coupling elements 235 and/or 237. In some examples, a locking mechanism 230 may be used to lock shuttle 206 at body 210. In the step depicted in FIG. 2B, implantation cable 204 is looped around bone 220 and locked in place at body 210 (for instance, via one or more shuttle engagement structures). In addition, in the step depicted in FIG. 2B, shuttle 206 may be coupled to cerclage wire 202.

[0119] Referring to FIG. 2C, implantation cable 204 has been retracted back into body 210. For example, handle 212 may be pulled out of body 210 in a direction away from bone 220, pulling implantation cable 204 into body 210. As a result, shuttle 206 has traveled back around bone 220 to rest at an implantation or distal end 213 of body 210. Because cerclage wire 202 is coupled to shuttle 206, retraction of implantation cable 204 may pull cerclage wire 202 around bone 220 to distal end 213 of body 210, thereby causing cerclage wire 202 to encircle bone 220.

[0120] Referring to FIG. 2C, implantation device 200 may be manipulated around bone 220 and out of the patient through incision 224. In the step depicted in FIG. 2C, only cerclage wire 202 remains in the patient, looped around bone 220. In some examples, cerclage wire 202 may be removed from implantation device 200, for example, via cutting cerclage wire 202 or releasing cerclage wire 202 and/or shuttle 206 from implantation device 200 via a release mechanism (not shown).

[0121] Although FIGS. 2A-2D depict a pulling implantation process operating using shuttle 206 to pull cerclage wire 202 around bone 220, examples are not so limited, as cerclage wire 202 may be implanted around bone 220 via direct attachment to implantation cable 204 without the use of shuttle 206. Accordingly, in some examples, a shuttle may not be used. In various examples, a cerclage wire may be directly coupled/de-coupled from an implantation cable the same or similar as described for a shuttle in the present disclosure.

[0122] FIGS. 3A-3D depict various views of a third illustrative example of an implantation device 300 in accordance with the present disclosure. More specifically, FIG. 3A depicts a side view of implantation device 300, FIG. 3B depicts a top-down view of implantation device 300, FIG. 3C depicts a perspective view from a handle end of implantation device 300, and FIG. 3D depicts a perspective view from an implantation end of implantation device 300. [0123] As shown in FIGS. 3A-3D, an implantation device 300 may include an at least partially hollow body 310 having a handle 312 configured to extend and retract an implantation cable 304 out of/into a body 310. Implantation device 300 may include a cerclage wire (not shown) arranged on and/or within body 310 according to various examples. The cerclage wire may be coupled to a portion of implantation cable 304 or a shuttle 306 coupled to the implantation cable.

[0124] In some examples, implantation device 300 may include a grip 316. For example, a first hand of an operator may hold onto grip 316, while a second hand of operator pulls/pushes on handle 312 to retract/extend implantation cable 304.

[0125] In various examples, implantation cable 304 may be coupled to a shuttle 306. Referring to FIG. 3C, therein is depicted a close-up of region 340 of implantation device 300. As shown in the close-up of region 340, implantation cable 304 may be a flat, wide elongated member formed as, for example, a flexible band or ribbon of memory material.

[0126] FIG. 3A depicts implantation device 300 in an initial state, with the shuttle end of implantation cable 304 arranged outside of body 310 in a loop 335. An operator may pull handle 312 in a proximal direction away from the implantation end of body 310, causing implantation cable 304 to unloop and to be pulled at least partially within body 310, placing implantation device 300 into an implantation state. In some examples, in the implantation state, all or substantially all of implantation cable 304 may be pulled into body. In some examples, shuttle 306 may be partially or wholly pulled into body 310. In various examples, shuttle is not pulled into body 310. The implantation end of body 310 is inserted into the patient incision and adjacent to the target bone (or around the target bone if body 310 is curved). The handle 312 is pushed distally toward body 310 to cause implantation cable 304 to extend out of body, pushing shuttle 306 and the implantation end of the implantation cable 304 around the bone. Because the cerclage wire (not shown) is coupled to the shuttle 306 (or the implantation end of implantation cable 304), the cerclage wire is also pushed around the bone along with the implantation cable. The cerclage wire may be decoupled from the shuttle 306 (or implantation cable 304) according to various examples within the present disclosure.

[0127] FIGS. 4A and 4B depict exploded views of the illustrative example of an implantation device shown in FIG. 3A in accordance with the present disclosure. More specifically, FIG. 4A depicts a top perspective exploded view of implantation device 300 and FIG. 4B depicts a side perspective exploded view of implantation device 300.

[0128] As shown in FIG. 4A, implantation device 300 may include a pusher component 331 configured to slidably move within housing 310. In some examples, pusher component 331 may include a handle connection component 330 on a handle end 337 configured to connect pusher component 331 to handle 312. Handle connection component 330 may include a flange, protrusion, or other element configured to be arranged within a corresponding cavity 332 of handle to couple handle connection component 330 to handle 312. In this manner, movement of handle in a push or pull motion may cause a corresponding movement of pusher component 330. In some examples, pusher component 330 may be connected to implantation cable 304 (for example, at a cable end 338 (see, FIG. 4D)). Accordingly, movement of pusher component 330 may cause a corresponding motion of implantation cable 304. [0129] In various examples, one or more bushings 340 may be arranged within housing 310. In some examples, implantation device 300 may include two bushings 340. In various examples, bushings 340 may be configured to secure, stabilize, facilitate operation of, etc. components of implantation device 300, such as securing implantation cable 304. In some examples, bushings 340 may be configured to reduce friction or “drag” on a portion of implantation cable 304. For instance, bushings 340 may operate to reduce drag on loop 335 (or the portion of implantation cable 304 that forms loop 335) as the implantation cable 304 is being pushed or pulled through housing and/or to provide stability for loop 335 to reduce or even eliminate undesirable rotation or increased friction during implantation in the patient (which may lead an operator to perceive that they are catching soft tissue when they are actually not and/or premature extension away from the bone rather than around the bone as desired).

[0130] FIGS. 4C-4G depict views of components of the illustrative example of an implantation device shown in FIG. 3A in accordance with the present disclosure. FIG. 4C depicts an illustrative example of housing 310. As shown in FIG. 4C, housing 310 may include a cable opening 334 for allowing implantation cable 304 to move in and out of housing 310. Housing 310 may include a pusher opening for allowing pusher component 330 to slide within housing 310. FIG. 4D depicts an illustrative example of pusher component 330. As shown in FIG. 4D, pusher component 330 may include handle end 337 configured to be coupled to handle 312 and a cable end 338 configured to be coupled to implantation cable 304.

[0131] FIGS. 4E-4G depict an illustrative example of implantation cable 304. More specifically, FIG. 4E depicts a side perspective view of implantation cable 304 and FIGS. 4F and 4G depict close-up perspective views of area 345 of FIG. 4E. As shown in FIGS. 4E-46, implantation cable may include a cable loop 335 and an insertion end 336. In some examples, at least a portion of insertion end 336 may have a width that is different than a width of the implantation cable 304. For instance, implantation cable 304 may have an insertion end tip that is less wide than the main implantation cable 304. In various examples, a shuttle 306 is arranged on or about insertion end 336.

[0132] The foregoing description has broad application. While the present disclosure refers to certain examples, numerous modifications, alterations, and changes to the described examples are possible without departing from the sphere and scope of the present disclosure, as defined in the appended claim(s). Accordingly, it is intended that the present disclosure not be limited to the described examples. Rather these examples should be considered as illustrative and not restrictive in character. All changes and modifications that come within the spirit of the described examples are to be considered within the scope of the disclosure. The present disclosure should be given the full scope defined by the language of the following claims, and equivalents thereof. The discussion of any example is meant only to be explanatory and is not intended to suggest that the scope of the disclosure, including the claims, is limited to these examples. In other words, while illustrative examples of the disclosure have been described in detail herein, it is to be understood that the inventive concepts may be otherwise variously embodied and employed, and that the appended claims are intended to be construed to include such variations, except as limited by the prior art.

Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the disclosure belongs.

[0133] Directional terms such as top, bottom, superior, inferior, medial, lateral, anterior, posterior, proximal, distal, upper, lower, upward, downward, left, right, longitudinal, front, back, above, below, vertical, horizontal, radial, axial, clockwise, and counterclockwise) and the like may have been used herein. Such directional references are only used for identification purposes to aid the reader’ s understanding of the present disclosure. For example, the term “distal” may refer to the end farthest away from the medical professional/operator when introducing a device into a patient, while the term “proximal” may refer to the end closest to the medical professional when introducing a device into a patient. Such directional references do not necessarily create limitations, particularly as to the position, orientation, or use of this disclosure. As such, directional references should not be limited to specific coordinate orientations, distances, or sizes, but are used to describe relative positions referencing particular examples. Such terms are not generally limiting to the scope of the claims made herein. Any example or feature of any section, portion, or any other component shown or particularly described in relation to various examples of similar sections, portions, or components herein may be interchangeably applied to any other similar example or feature shown or described herein.

[0134] It should be understood that, as described herein, an "example" (such as illustrated in the accompanying Figures) may refer to an illustrative representation of an environment or article or component in which a disclosed concept or feature may be provided or embodied, or to the representation of a manner in which just the concept or feature may be provided or embodied. However, such illustrated examples are to be understood as examples (unless otherwise stated), and other manners of embodying the described concepts or features, such as may be understood by one of ordinary skill in the art upon learning the concepts or features from the present disclosure, are within the scope of the disclosure. Furthermore, references to “one example” of the present disclosure are not intended to be interpreted as excluding the existence of additional examples that also incorporate the recited features.

[0135] In addition, it will be appreciated that while the Figures may show one or more examples of concepts or features together in a single example of an environment, article, or component incorporating such concepts or features, such concepts or features are to be understood (unless otherwise specified) as independent of and separate from one another and are shown together for the sake of convenience and without intent to limit to being present or used together. For instance, features illustrated or described as part of one example can be used separately, or with another example to yield a still further example. Thus, it is intended that the present subject matter covers such modifications and variations as come within the scope of the appended claims and their equivalents.

[0136] As used herein, an element or step recited in the singular and proceeded with the word “a” or “an” should be understood as not excluding plural elements or steps, unless such exclusion is explicitly recited. It will be further understood that the terms “comprises” and/or “comprising,” or “includes” and/or “including” when used herein, specify the presence of stated features, regions, steps, elements and/or components, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components and/or groups thereof. [0137] The phrases “at least one”, “one or more”, and “and/or”, as used herein, are open-ended expressions that are both conjunctive and disjunctive in operation. The terms “a” (or “an”), “one or more” and “at least one” can be used interchangeably herein.

[0138] Connection references (e.g., engaged, attached, coupled, connected, and joined) are to be construed broadly and may include intermediate members between a collection of elements and relative to movement between elements unless otherwise indicated. As such, connection references do not necessarily infer that two elements are directly connected and in fixed relation to each other. Identification references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to connote importance or priority, but are used to distinguish one feature from another. The drawings are for purposes of illustration only and the dimensions, positions, order and relative to sizes reflected in the drawings attached hereto may vary.

[0139] The foregoing discussion has been presented for purposes of illustration and description and is not intended to limit the disclosure to the form or forms disclosed herein. For example, various features of the disclosure are grouped together in one or more examples or configurations for the purpose of streamlining the disclosure.

However, it should be understood that various features of the certain examples or configurations of the disclosure may be combined in alternate examples or configurations. Moreover, the following claims are hereby incorporated into this Detailed Description by this reference, with each claim standing on its own as a separate example of the present disclosure.

Claims

CLAIMS What is claimed is:

1. A cerclage wire implantation device, comprising: a body having an implantation end and a hollow portion; an implantation cable at least partially arranged within the hollow portion; a shuttle coupled to a shuttle end of the implantation cable, the shuttle end arranged at the implantation end of the body; a cerclage wire; and a handle coupled to a handle end of the implantation cable, the handle end arranged opposite the shuttle end.

2. The cerclage wire implantation device of claim 1 , the implantation end configured to be positioned within an incision of a patient and adjacent to a bone of the patient.

3. The cerclage wire implantation device of claim 2, the implantation end having a curved or hooked shape configured to be positioned around at least a portion of the bone.

4. The cerclage wire implantation device of claim 2, the shuttle end of the implantation cable configured to form a loop having a predetermined radius.

5. The cerclage wire implantation device of claim 2, the handle configured to be pushed toward the insertion end of the body to cause the implantation cable to extend out of an opening at the implantation end of the body and around the bone.

6. The cerclage wire implantation device of claim 5, movement of the implantation cable configured to cause corresponding movement of the shuttle around the bone.

7. The cerclage wire implantation device of claim 6, the shuttle having a face shaped to cut through tissue to facilitate movement of the shuttle around the bone.

8. The cerclage wire implantation device of claim 6, the cerclage wire coupled to the shuttle.

9. The cerclage wire implantation device of claim 8, the shuttle configured to push the cerclage wire around the bone as the shuttle travels around the bone.

10. The cerclage wire implantation device of claim 9, further comprising a locking mechanism configured to couple the shuttle to the body after the shuttle has encircled the bone and exited the incision.

11. The cerclage wire implantation device of claim 10, the implantation cable configured to be released from the shuttle, when the shuttle is coupled to the body, and retracted within the body.

12. The cerclage wire implantation device of claim 6, the cerclage wire coupled to the body.

13. The cerclage wire implantation device of claim 12, the shuttle configured to be coupled to the cerclage wire after the shuttle has encircled the bone and exited the incision.

14. The cerclage wire implantation device of claim 10, the implantation cable configured to be retracted within the body, pulling the shuttle and the cerclage wire coupled to the shuttle around the bone, wherein at least a portion of the cerclage wire encircles the bone when the implantation cable is fully retracted within the body.

15. The cerclage wire implantation device of one of claims 9 or 14, the body configured to be removed from the patient via the incision, wherein the cerclage wire is retained around the bone.

16. The cerclage wire implantation device of claim 1 , the handle coupled to the cerclage wire via an extension structure.

17. The cerclage wire implantation device of claim 1, the handle configured to be pulled in a retraction direction away from the extension end of the body to retract the implantation cable, at least partially, within the body, and pushed in an extension direction toward the implantation end of the body to extend, at least partially, the implantation cable outside of the body.

18. The cerclage wire implantation device of claim 1, the implantation cable formed of a memory material.

19. The cerclage wire implantation device of claim 18, the memory material comprising at least one of a shape memory material (SMM), a shape memory alloy (SMA), nickel (Ni), titanium (Ti), copper (Cu), zinc (Zn), aluminum (Al), Ni-Ti materials, nitinol, Cu-Zn-Al materials, or Cu-Al-Ni materials.

20. The cerclage wire implantation device of claim 1, the implantation cable having a flat or substantially flat shape.

21. The cerclage wire implantation device of claim 1, the shuttle releasably coupled to the implantation cable.

22. The cerclage wire implantation device of claim 1, the bone comprising a shaft of a femur.

23. A method of implanting a cerclage wire around a bone of a patient, the method, comprising: inserting an implantation end of a body of an implantation device into an incision in the patient and adjacent to the bone, the implantation device comprising: an implantation cable at least partially arranged within the body, a shuttle coupled to a shuttle end of the implantation cable, the shuttle end arranged at the implantation end of the body, a cerclage wire coupled to the shuttle, and a handle coupled to a handle end of the implantation cable, the handle end arranged opposite the shuttle end; and pushing the handle toward the implantation end to cause the implantation cable to extend out of an opening at the implantation end of the body and to move with the shuttle around the bone, the shuttle configured to push the cerclage wire around the bone as the shuttle travels around the bone.

24. The method of claim 23, the implantation end having a curved or hooked shape configured to be positioned around at least a portion of the bone.

25. The method of claim 23, the shuttle end of the implantation cable configured to form a loop having a predetermined radius.

26. The method of claim 23, the shuttle having a face shaped to cut through tissue to facilitate movement of the shuttle around the bone.

27. The method of claim 23, further comprising coupling the shuttle to the body, via a locking mechanism, after the shuttle has encircled the bone and exited the incision

28. The method of claim 27, further comprising releasing the implantation cable from the shuttle, when the shuttle is coupled to the body, thereby retracting the implantation cable within the body.

29. The method of claim 28, further comprising removing the body from the patient via the incision, wherein the cerclage wire is retained around the bone.

30. The method of claim 23, the handle coupled to the cerclage wire via an extension structure.

31 . The method of claim 23, the handle configured to be pulled in a retraction direction away from the extension end of the body to retract the implantation cable, at least partially, within the body, and pushed in an extension direction toward the implantation end of the body to extend, at least partially, the implantation cable outside of the body.

32. The method of claim 23, the implantation cable formed of a memory material.

33. The method of claim 32, the memory material comprising at least one of a shape memory material (SMM), a shape memory alloy (SMA), nickel (Ni), titanium (Ti), copper (Cu), zinc (Zn), aluminum (Al), Ni-Ti materials, nitinol, Cu-Zn-Al materials, or Cu-Al-Ni materials.

34. The method of claim 23, the implantation cable having a flat or substantially flat shape.

35. The method of claim 23, the shuttle releasably coupled to the implantation cable.

36. The method of claim 23, the bone comprising a shaft of a femur.

37. A method of implanting a cerclage wire around a bone of a patient, the method, comprising: inserting an implantation end of a body of an implantation device into an incision in the patient and adjacent to the bone, the implantation device comprising: an implantation cable at least partially arranged within the body, a shuttle coupled to a shuttle end of the implantation cable, the shuttle end arranged at the implantation end of the body, a cerclage wire coupled to the body, and a handle coupled to a handle end of the implantation cable, the handle end arranged opposite the shuttle end; pushing the handle toward the implantation end to cause the implantation cable to extend out of an opening at the implantation end of the body and to move with the shuttle around the bone, out of the incision, and to couple to the cerclage wire; and retracting the implantation cable within the body, pulling the shuttle and the cerclage wire coupled to the shuttle around the bone, wherein at least a portion of the cerclage wire encircles the bone when the implantation cable is fully retracted within the body.

38. The method of claim 37, the implantation end having a curved or hooked shape configured to be positioned around at least a portion of the bone.

39. The method of claim 37, the shuttle end of the implantation cable configured to form a loop having a predetermined radius.

40. The method of claim 37, the shuttle having a face shaped to cut through tissue to facilitate movement of the shuttle around the bone.

41. The method of claim 37, further comprising removing the body from the patient via the incision, wherein the cerclage wire is retained around the bone.

42. The method of claim 37, the handle coupled to the cerclage wire via an extension structure.

43. The method of claim 37, the handle configured to be pulled in a retraction direction away from the extension end of the body to retract the implantation cable, at least partially, within the body, and pushed in an extension direction toward the implantation end of the body to extend, at least partially, the implantation cable outside of the body.

44. The method of claim 37, the implantation cable formed of a memory material.

45. The method of claim 44, the memory material comprising at least one of a shape memory material (SMM), a shape memory alloy (SMA), nickel (Ni), titanium (Ti), copper (Cu), zinc (Zn), aluminum (Al), Ni-Ti materials, nitinol, Cu-Zn-Al materials, or Cu-Al-Ni materials.

46. The method of claim 37, the implantation cable having a flat or substantially flat shape.

47. The method of claim 37, the shuttle releasably coupled to the implantation cable.

48. The method of claim 37, the bone comprising a shaft of a femur.