Orthopedic implant and instrument for delivering the same

Abstract

To provide a system and a method for treating bone fractures, especially small bone fractures.SOLUTION: A fracture treatment system can include a pair of implants cross-pinned into the medullary canal of a bone, guided by at least one guide wire with at least two diameters. The system allows for more accurate sizing of length of implants needed to achieve bicortical purchase for enhanced stability, as well as anti-rotation of the fracture site. The more accurate sizing and placement of the cross-pinned implants additionally allow both ends of the implants to recess beneath or be flush with an outer surface of the bone, which can reduce risk of infection.SELECTED DRAWING: Figure 4A

Description

[Technical field]

[0001] [Incorporation by reference of priority application] Any and all applications for which a foreign or domestic priority claim is identified in an Application Data Sheet filed with this application are incorporated by reference under 37 CFR 1.57. This application claims the benefit of priority to U.S. Provisional Application No. 62 / 988,298, filed March 11, 2020, which is incorporated by reference in its entirety.

[0002] [Technical field] The present disclosure relates to systems and methods for treating bone fractures, particularly bone fractures. [Background technology]

[0003] Hand and foot injuries are common. For example, approximately 20% of all emergency department visits are due to traumatic finger injuries. These injuries can include sports and work-related injuries. As many as 5% of hand injuries may require surgical intervention.

[0004] Fractures of the phalanges and metacarpals are among the most common skeletal injuries. Fractures have an estimated national incidence of 12.5% ​​for phalanges and 8.4% for metacarpals per 10,000 people per year. Such fractures can be inconvenient or even debilitating for the patient. For example, lost productivity associated with phalangeal fractures is estimated to exceed $2 billion per year in the United States.

[0005] The primary goal of phalangeal and metacarpal fracture treatment includes restoring the anatomy of the broken bone and preserving function as soon as possible. Small fractures, such as phalangeal and metacarpal fractures, can be treated using, for example, K-wires, intraosseous wires, tendon band wires, compression screws, fixation plates, or external fixation. Some of these procedures are performed percutaneously. Summary of the Invention [Problem to be solved by the invention]

[0006] Current standard treatments for small fractures can result in poor rotational control, delayed mobilization, persistent stiffness, reduced range of motion, soft tissue inflammation, increased surgical exposure, and postoperative tendon adhesions, among other drawbacks.

[0007] Better rotational control and / or bone reduction can be achieved with implants that retain both cortical walls (also called "bi-cortical retention"). Currently, this procedure is performed using cross-fixed prefabricated K-wires. However, there are drawbacks to the use of prefabricated K-wires. For example, with the use of prefabricated K-wires, at least one end of the K-wire protrudes from the bone surface. The protruding end of the K-wire can cause fixation site infection. [Means for solving the problem]

[0008] The present disclosure can improve the surgical outcome of cruciate fixation techniques using a combination of a fracture fixation implant and a guidewire having at least two diameters, such as a dual diameter guidewire. The fracture fixation system disclosed herein can be delivered percutaneously to avoid the need for open reduction. The fracture fixation system and delivery method disclosed herein can shorten and / or minimize surgery time, recovery time, and / or infection, and can facilitate return to activity. The fracture fixation system and delivery method disclosed herein can also restore anatomy more quickly and allow mobilization of the injured digit (finger or toe) as soon as fracture stability is possible. The fracture fixation system disclosed herein can also provide a method for the treatment of a fracture that is more stable and / or more stable. The stem and delivery method may also minimize soft tissue trauma and / or impingement.

[0009] The fracture fixation system of the present disclosure may include two intramedullary fixation implants, which may be threaded and cross-fixed in the medullary canal guided by a customized guidewire with at least two diameters. Alternatively, the two implants may be implanted substantially parallel to one another. The system allows for more precise sizing of the implants to the length required to achieve bicortical retention for improved stability as well as anti-rotation of the fracture site. More precise sizing and placement of the implants may also allow both the distal and proximal ends of the implant to be recessed below or flush with the outer cortical wall, reducing the risk of infection. The fixation implants are also designed to reduce displacement after implantation, for example by having threads or otherwise non-smooth outer shaft surfaces.

[0010] In the present disclosure, an example of an intramedullary fracture fixation system can include a first elongated implant and a second elongated implant configured to be inserted into the medullary canal of a fractured bone, each of the first and second elongated implants configured to be embedded across the medullary canal into either side of the cortical wall of the fractured bone, each of the first and second elongated implants configured not to protrude into tissue surrounding the bone, each of the first and second elongated implants being cannulated. The system can be a sterile kit, and the first and second elongated implants can be provided in a sterile package.

[0011] In one form, the first and second elongate implants may be configured to fix a phalangeal fracture.

[0012] In one form, each of the first and second elongate implants can include a driver head interface at an end of the implant.

[0013] In one form, the driver head interface may comprise a hexagonal head interface.

[0014] In one form, the first elongate implant can have a length that is the same as the length of the second elongate implant.

[0015] In one form, the first elongate implant can have a length that is different from the length of the second elongate implant.

[0016] In one embodiment, the first or second elongate implant may have a length of between 10mm and 50mm.

[0017] In one embodiment, the first or second elongate implant may have a length of between 30mm and 50mm.

[0018] In one form, the first or second elongate implant can have an outer shaft diameter of less than 2.5 mm.

[0019] In one form, the first or second elongate implant can have an outer shaft diameter of less than 2.2 mm.

[0020] In one form, the first and / or second elongate implants can be threaded.

[0021] In one form, the first elongate implant and the second elongate implant can be configured to be cross-fixed within the medullary canal.

[0022] In one form, the first elongate implant and the second elongate implant can be configured to be inserted substantially parallel to one another.

[0023] In one form, the system can further include one or more insertion tools having a larger diameter portion configured to prepare a passageway within the fractured bone and a smaller diameter portion configured to guide the first and / or second elongated implants through the passageway such that the respective ends of the first and second elongated implants do not protrude into tissue surrounding the bone.

[0024] In the present disclosure, one example of a guidewire having at least two diameters and configured to deliver an intubating orthopedic implant can include a first portion having a first substantially uniform outer diameter and a second portion having a second substantially uniform outer diameter that is larger than the first substantially uniform outer diameter, the intubating orthopedic implant can be configured to be slidably mounted on the first portion of the guidewire, and the second substantially uniform outer diameter is substantially the same as a minor or root diameter of the intubating orthopedic implant.

[0025] In one form, the free end of the second portion may be provided with a sharp tip.

[0026] In one form, the first substantially uniform outer diameter can be between 0.7 mm and 0.9 mm.

[0027] In one form, the second substantially uniform outer diameter can be between 1.5 mm and 2.0 mm.

[0028] In one form, the first portion and the second portion may be removably connected.

[0029] In one form, the second portion can include a cannulation portion configured to receive the first portion.

[0030] In one form, the cannulation section may extend along the entire length of the second portion.

[0031] In one form, the cannulation section may extend along a partial length of the second portion.

[0032] In one form, one of the first or second portions may include a hook and the other of the first or second portions may include a loop.

[0033] A method for delivering an elongated threaded orthopedic implant into bone, where the implant is at least partially cannulated, can use any of the guidewire configurations described above. The method can include preparing a passage in the bone using a second portion of the guidewire according to any one of claims 1 to 9, the passage having a diameter substantially the same as a root or minor diameter of the elongated threaded orthopedic implant, inserting a first portion of the guidewire into the cannulated portion of the implant, and advancing the implant through the passage, guided by the first portion of the guidewire.

[0034] A method of delivering an elongated threaded orthopedic implant into bone, where the implant is at least partially cannulated, includes the steps of preparing a passageway in the bone using an insertion tool, the passageway being substantially the same as a root or minor diameter of the elongated orthopedic implant. having the same diameter, and forcing the implant through the passage guided by an insertion tool, where a leading end of the implant is removably coupled to a trailing end of the insertion tool.

[0035] In one form, the method can further include releasably coupling a leading end of the implant to a trailing end of the insertion tool, the trailing end of the insertion tool can include a bore configured to receive the leading end of the implant.

[0036] In one form, the holes can be unthreaded.

[0037] In one form, the hole can be threaded.

[0038] In one form, the propelling step can be performed using a power tool.

[0039] In one form, the leading end of the implant can be connected to the trailing end of the insertion tool by a weakened section, and the method can further include decoupling the insertion tool from the implant at the weakened section.

[0040] In one form, the rear end of the implant can be coupled to the drive tool by a second weakened section, and the method can further include decoupling the drive tool from the implant at the second weakened section.

[0041] In the present disclosure, an example of an intramedullary fracture fixation method includes the steps of delivering a guidewire having at least two diameters across a fractured portion of a fractured bone, the guidewire having a first rear portion having a first diameter and a second front portion having a second diameter larger than the first diameter, and the delivery includes extending a second portion of the guidewire across the medullary canal of the bone until a front end of the guidewire is substantially flush with an outer surface of the bone; selecting a cannulated long implant by determining a length of the cannulated long implant based on a position of the guidewire within the bone; slidably mounting the cannulated long implant on the first portion of the guidewire; inserting the cannulated long implant guided by the guidewire into the bone, wherein an end of the cannulated long implant does not protrude from the outer surface of the bone; and removing the guidewire from the bone.

[0042] In the present disclosure, an example of an intramedullary fracture fixation method includes the steps of delivering a first guidewire having at least two diameters across a fractured portion of a fractured bone, the first guidewire having a first rear portion having a first diameter and a second front portion having a second diameter larger than the first diameter, the delivery including extending a second portion of the first guidewire across the medullary canal of the bone until a front end of the first guidewire is substantially flush with an outer surface of the bone; selecting a first cannulated long implant by determining a length of the first cannulated long implant based on a position of the first guidewire within the bone; slidably mounting the first cannulated long implant on a first portion of the first guidewire; inserting the first cannulated long implant guided by the first guidewire into the bone; and removing the first guidewire from the bone. The method may include the steps of: delivering a second guidewire having at least two diameters across a fractured portion of a fractured bone, the second guidewire having a first rear portion having a first diameter and a second front portion having a second diameter larger than the first diameter, and the delivering including extending a second portion of the second guidewire across the medullary canal of the bone until a front end of the second guidewire is substantially flush with an outer surface of the bone; selecting a second cannulated long implant by determining a length of the second cannulated long implant based on a position of the second guidewire within the bone; slidably mounting the second cannulated long implant on a first portion of the second guidewire; inserting the second cannulated long implant guided by the second guidewire into the bone; and removing the second guidewire from the bone.

[0043] In one form, each of the first and second implants can be bicortical.

[0044] In one form, each of the first and second implants can terminate at or before the outer surface of the bone.

[0045] In one form, the ends of each of the first and second implants may not protrude into the tissue surrounding the bone.

[0046] In one form, delivery of the second guidewire may occur after removing the first guidewire from the bone.

[0047] In one form, delivery of the second guidewire can occur after delivery of the first guidewire and before inserting the first implant.

[0048] In one form, the delivering step can include extending a second portion of the second guidewire across the medullary canal of the bone in a pattern that intersects with a tunnel in the bone formed by the second portion of the first guidewire.

[0049] In one form, the delivering step can include extending a second portion of a second guidewire across the medullary canal of the bone substantially parallel to a tunnel in the bone formed by the second portion of the first guidewire.

[0050] In the present disclosure, one example of a kit for an intramedullary fracture system can include a first elongated implant, the first elongated implant being cannulated and having a first implant shaft outer diameter and a first implant cannulation diameter, and a guide wire having at least two diameters and can be configured to deliver the first implant into the fractured bone via intramedullary fixation. The guidewire can have a first rear portion having a first diameter and a second front portion having a second diameter larger than the first diameter, the second diameter being substantially the same as the first implant shaft outer diameter (or the first implant root diameter or minor diameter), and the first implant cannulation diameter being configured to receive the first portion of the guidewire, and the kit can include a second elongated implant configured to be implanted together with the first implant by intramedullary fixation, the second elongated implant being cannulated and having a second implant shaft outer diameter (or the second implant root diameter or minor diameter) and a second implant cannulation diameter, and the second diameter of the guidewire can be substantially the same as the second implant shaft outer diameter or the second implant root diameter or minor diameter, and the second implant cannulation diameter can be configured to receive the first portion of the guidewire.

[0051] In one form, the kit can further include a second guidewire having at least two diameters and configured to deliver a second implant into the fractured bone for intramedullary fixation, the second guidewire having a first rear portion having a first diameter and a second front portion having a second diameter larger than the first diameter, the second diameter being substantially the same as a second implant shaft outer diameter or a second implant root or minor diameter, and the second implant cannulation diameter configured to receive a first portion of the second guidewire.

[0052] In one form, the first and / or second elongate implants can be threaded.

[0053] In one form, the second elongate implant can be configured to be implanted in a cross pattern with the first implant.

[0054] In one form, the second elongate implant can be configured to be implanted substantially parallel to the first implant.

[0055] The surgical kit may be used to perform fracture fixation using a cannulated implant, which may include a head and an at least partially threaded shaft. The surgical kit may include a guidewire having at least two diameters and configured to guide delivery of the implant into the fractured bone, the guidewire including a first rear portion having a first diameter and a second front portion having a second diameter greater than the first diameter, the second diameter being substantially the same as a minor diameter of the shaft of the implant, the first diameter of the first portion configured to slidably engage the cannulated portion of the implant, a sizing tool, and a driver configured to engage the head of the implant to drive the implant into the bone.

[0056] In one form, the surgical kit may further comprise a sterile sealed package, and the guidewire, sizing tool, and driver may be contained within the sterile sealed package.

[0057] In one form, the guidewire, sizing tool, and / or driver may be configured to be disposable.

[0058] In one form, the guidewire, sizing tool, and / or driver may be reusable by being sterilized after each use.

[0059] The fracture fixation method includes the steps of delivering a guidewire having at least two diameters across a fractured portion of a fractured bone, the guidewire having a first rear portion having a first diameter and a second front portion having a second diameter larger than the first diameter, the delivery including extending the second portion of the guidewire through the cortex of the bone from a side closer to an insertion location of the guidewire on the bone to a side farther from the insertion location; slidably mounting a cannulated elongated implant over the first portion of the guidewire, the implant having an at least partially threaded shaft, the threads being on a portion of the shaft extending from a front end of the implant toward a head of the implant; inserting the cannulated elongated implant into the bone guided by the guidewire, the threads of the implant engaging the cortex farther from the insertion location; and removing the guidewire from the bone by pulling the second portion of the guidewire away from the bone at the side farther from the insertion location.

[0060] In one form, the method may further include the step of selecting a desired length implant using a sizing guide.

[0061] In one form, the cannulated elongate implant can be a lag screw having a head and a shaft, and when inserted into the bone, the head of the lag screw can engage the cortex proximal to the insertion location.

[0062] In one form, the minor diameter of the shaft of the lag screw can be substantially the same as the outer diameter of the second portion of the guidewire.

[0063] In one form, the method may not include pre-drilling the bone prior to delivering the guidewire into the bone.

[0064] For purposes of summary, certain aspects, advantages, and novel features are described herein. Of course, it should be understood that not all such aspects, advantages, or features need to be present in any particular embodiment. [Brief description of the drawings]

[0065] These and other features, aspects, and advantages of the present disclosure will be described in connection with drawings of specific embodiments, which are intended to illustrate specific embodiments in a schematic manner and are not intended to limit the disclosure.

[0066] [Figure 1] 1 shows an x-ray view of prior art cross-fixed K-wires implanted in a finger bone.

[0067] [Figure 2A] 1 illustrates a side view of an example of an implant of the present disclosure.

[0068] [Figure 2B] FIG. 2B shows a cross-sectional view of the implant of FIG. 2A taken along its longitudinal axis (axis BB).

[0069] [Figure 2C] FIG. 2B shows a rear end view of the implant of FIG. 2A.

[0070] [Figure 2D] FIG. 2B shows a front end view of the implant of FIG. 2A.

[0071] [Figure 2E] 2B shows a partial cross-sectional view of the implant of FIG. 2A along axis CC.

[0072] [Figure 2F] 2B shows a partial cross-sectional view of the implant of FIG. 2A along axis AA.

[0073] [Figure 3A] FIG. 2B shows a side view of an unthreaded (also called a "blank") version of the implant of FIG. 2A. [Figure 3B] FIG. 2B shows a front-end view of an unthreaded (also called a "blank") version of the implant of FIG. 2A.

[0074] [Figure 4A] FIG. 1 illustrates a perspective view of an example of a customized guidewire having at least two diameters.

[0075] [Figure 4B] 4B shows a side view of the guidewire of FIG. 4A.

[0076] [Figure 4C] FIG. 4B shows a front end view of the guidewire of FIG. 4A.

[0077] [Figure 5A] FIG. 2B shows a front view of an example of a sizing tool for use in delivering the device of FIG. 2A.

[0078] [Figure 5B] FIG. 5B shows a side view of the sizing tool of FIG. 5A.

[0079] [Figure 5C] FIG. 5B shows an end view of the dimensioning tool of FIG. 5A.

[0080] [Figure 5D] FIG. 5B shows a detailed view of a portion of the dimensioning tool of FIG. 5A.

[0081] [Figure 6A] 2B shows an exploded view of an example of a driver configured to deliver the implant of FIG. 2A.

[0082] [Figure 6B] 6B shows a front view of the driver of FIG. 6A.

[0083] [Figure 6C] 6B shows a detailed view of the driver head portion of the driver of FIG. 6A.

[0084] [Figure 6D] 6C taken along axis BB. FIG.

[0085] [Figure 7A] 1 shows a side view of another example implant of the present disclosure.

[0086] [Figure 7B] FIG. 7B shows a rear end view of the implant of FIG. 7A.

[0087] [Figure 7C] FIG. 7B shows a front end view of the implant of FIG. 7A.

[0088] [Figure 7D] 7B shows a cross-sectional view of the implant of FIG. 7A taken along its longitudinal axis (axis BB).

[0089] [Figure 8A] 2B illustrates certain steps of an example of a method for implanting the implant of FIG. 2A. [Figure 8B] 2B illustrates certain steps of an example of a method for implanting the implant of FIG. 2A. [Figure 8C] 2B illustrates certain steps of an example of a method for implanting the implant of FIG. 2A. [Figure 8D] 2B illustrates certain steps of an example of a method for implanting the implant of FIG. 2A. [Figure 8E] 2B illustrates certain steps of an example of a method for implanting the implant of FIG. 2A. [Figure 8F] 2B illustrates certain steps of an example of a method for implanting the implant of FIG. 2A. [Figure 8G] 2B illustrates certain steps of an example of a method for implanting the implant of FIG. 2A.

[0090] [Figure 9A] 2B illustrates certain steps of an example of another method for implanting the implant of FIG. 2A. [Figure 9B] 2B illustrates certain steps of an example of another method for implanting the implant of FIG. 2A. [Figure 9C] 2B illustrates certain steps of an example of another method for implanting the implant of FIG. 2A. [Figure 9D]2B illustrates certain steps of an example of another method for implanting the implant of FIG. 2A. [Figure 9E] 2B illustrates certain steps of an example of another method for implanting the implant of FIG. 2A. [Figure 9F] 2B illustrates certain steps of an example of another method for implanting the implant of FIG. 2A.

[0091] [Figure 10] 2B illustrates a schematic diagram of an example of another method for implanting the implant of FIG. 2A.

[0092] [Figure 11A] 1A-1D are schematic diagrams illustrating examples of lag screw fixation for various metacarpal or phalangeal fractures. [Figure 11B] 1A-1D are schematic diagrams illustrating examples of lag screw fixation for various metacarpal or phalangeal fractures. [Figure 11C] 1A-1D are schematic diagrams illustrating examples of lag screw fixation for various metacarpal or phalangeal fractures.

[0093] [Figure 12A] 1 illustrates an example of a challenge with a conventional lag screw implantation procedure. [Figure 12B] 1 illustrates an example of a challenge with a conventional lag screw implantation procedure. [Figure 12C] 1 illustrates an example of a challenge with a conventional lag screw implantation procedure. [Figure 12D] 1 illustrates an example of a challenge with a conventional lag screw implantation procedure.

[0094] [Figure 13] 1 illustrates an example of a lag screw coupled to a stepped guidewire as disclosed herein.

[0095] [Figure 14A] 14 illustrates certain steps of an example method for implanting the lag screw of FIG. 13. [Figure 14B] 14 illustrates certain steps of an example method for implanting the lag screw of FIG. 13. [Figure 14C]14 illustrates certain steps of an example method for implanting the lag screw of FIG. 13. [Figure 14D] 14 illustrates certain steps of an example method for implanting the lag screw of FIG. 13. [Figure 14E] 14 illustrates certain steps of an example method for implanting the lag screw of FIG. 13.

[0096] [Figure 15] 1A-1C are schematic diagrams illustrating examples of packaging for the implants and surgical instruments disclosed herein.

[0097] [Figure 16] 1 shows an x-ray image of a lag screw placed in a metacarpal bone with an intramedullary implant.

[0098] [Figure 17A] 1 shows examples of lag screws for various fixation of the bones of the foot. [Figure 17B] 1 shows examples of lag screws for various fixation of the bones of the foot.

[0099] [Figure 18A] 13A-13C illustrate various exemplary alternative delivery tools to a stepped guidewire for delivering the implants disclosed herein. [Figure 18B] 13A-13C illustrate various exemplary alternative delivery tools to a stepped guidewire for delivering the implants disclosed herein. [Figure 19] 13A-13C illustrate various exemplary alternative delivery tools to a stepped guidewire for delivering the implants disclosed herein. [Figure 20] 13A-13C illustrate various exemplary alternative delivery tools to a stepped guidewire for delivering the implants disclosed herein. [Figure 21A] 13A-13C illustrate various exemplary alternative delivery tools to a stepped guidewire for delivering the implants disclosed herein. [Figure 21B]13A-13C illustrate various exemplary alternative delivery tools to a stepped guidewire for delivering the implants disclosed herein. [Figure 22A] 13A-13C illustrate various exemplary alternative delivery tools to a stepped guidewire for delivering the implants disclosed herein. [Figure 22B] 13A-13C illustrate various exemplary alternative delivery tools to a stepped guidewire for delivering the implants disclosed herein. [Figure 22C] 13A-13C illustrate various exemplary alternative delivery tools to a stepped guidewire for delivering the implants disclosed herein. [Figure 23] 13A-13C illustrate various exemplary alternative delivery tools to a stepped guidewire for delivering the implants disclosed herein. [Figure 24] 13A-13C illustrate various exemplary alternative delivery tools to a stepped guidewire for delivering the implants disclosed herein. [Figure 25A] 13A-13C illustrate various exemplary alternative delivery tools to a stepped guidewire for delivering the implants disclosed herein. [Figure 25B] 13A-13C illustrate various exemplary alternative delivery tools to a stepped guidewire for delivering the implants disclosed herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0100] Although specific embodiments and examples are described below, those skilled in the art will recognize that the disclosure extends beyond the specifically disclosed embodiments and / or uses and their obvious modifications and equivalents. For example, the exemplary cruciate-locked intramedullary fixation system may be implanted in bones in other parts of the human body, such as the foot. Thus, it is not intended that the scope of the disclosure herein should be limited by any specific embodiments described below.

[0101] In fracture treatment, a single long intramedullary implant may not have sufficient rotational control when used to stabilize a fractured bone, e.g., a phalangeal bone. The fractured finger has a tendency to rotate on the longitudinal axis of the implant. It is beneficial that the implant can resist rotation, cannot protrude from the bone into the soft tissue, and is strong enough to allow the patient to regain function of the fractured finger sooner than with the current standard of care. Better rotational control and / or bone reduction can be achieved with two cross-locked intramedullary implants, each retaining both cortical walls of the bone, i.e., bicortical retention. Alternatively, two implants can be implanted substantially parallel to each other, each with bicortical retention.

[0102] Currently, cruciate fixation procedures are performed using standard off-the-shelf K-wires. Such K-wires can have an outer diameter of about 1.1 mm (0.045 inches) to about 1.6 mm (0.060 inches). FIG. 1 illustrates the implantation of a pair of cruciate fixation standard K-wires 2, 4 to treat a fractured phalange 6 of a human hand. However, results with cruciate fixation standard K-wires 2, 4 are unsatisfactory for a number of reasons. For example, the K-wires 2, 4 have a nearly uniform outer shaft diameter and a relatively smooth outer surface, thus resulting in poor bone retention. Due to poor bone retention, the K-wires 2, 4 can easily become displaced post-operatively.

[0103] Furthermore, poor results may be due to the fact that the length of the K-wires 2, 4 cannot be sized appropriately for the size of the phalanges 6. When the K-wires are inserted to treat a fractured bone, they penetrate the skin, fascia, fat, tendons, periosteum, etc. before reaching the bone. As shown in FIG. 1, when the K-wires 2, 4 are implanted across the medullary canal 9 and across the cortical wall of the nearly diametrically opposed sides 8, 10 of the phalanges 6, a portion of the K-wires 2, 4 at the posterior ends 12, 14 is exposed percutaneously. The portions of the K-wires 2, 4 at the anterior ends 16, 18 may also protrude outward, i.e., stick out, from the outer surface 20 of the phalanges 6. The percutaneously exposed portions of the posterior ends 12, 14 may be cut off using wire cutters. However, the K-wires 2, 4 at the posterior ends 12, 14 may still protrude from the outer surface of the phalanges 6. Thus, the anterior end 16, 18 and / or posterior end 12, 14 of the K-wire 2, 4 can protrude from the outer surface 20 of the phalangeal bone 6 by at least about 1 mm to about 2 mm. Due to the protruding anterior end 16, 18 and / or posterior end 12, 14 of the K-wire 2, 4 from the outer surface 20 of the bone 6, scarring from the bone to the skin can occur. The tissue layers surrounding the bone 6 can slide against the scarring, thereby causing adhesion of the tissue layers. Furthermore, the severed posterior end 12, 14 of the K-wire can still be exposed in the wound on the skin, which can cause fixation site infection. In one study, metacarpal fractures treated with exposed K-wires were twice as likely to be treated for fixation site infection (17.6% of exposed K-wire cases vs. 8.7% of buried K-wire cases).

[0104] Due to inadequate fixation and / or the need to reduce the incidence of tissue damage or fixation site infection, it may be necessary to further stabilize the fractured finger using a cast after implantation of the cruciate-fixed K-wires, which may cause more inconvenience to the patient and may further delay the recovery of the fractured finger.

[0105] To improve bone retention of fixation implants, threaded implants such as screws can be used. The screw may need to be delivered through a K-wire and therefore needs to be cannulated. The cannulated delivery technique can make the surgical procedure safer and easier since the delivery path can be guided by a pre-inserted guide wire such as a K-wire. K-wires suitable for this cannulated delivery technique preferably have an outer diameter of at least about 1.1 mm. K-wires with an outer diameter smaller than 1.1 mm are less stiff and too flexible, which can cause the K-wire to skive when inserted into the bone with a driver and tend to deviate from a straight path into the bone. However, standard cannulated prefabricated screws may have a diameter that is too large for use in intramedullary fixation of the phalanges or fixation of other hand and / or foot bones. This is because the screw needs to be at least about 2.8 mm and no more than about 3 mm in shaft outer diameter to have a cannulated section large enough to accept a K-wire with an outer diameter of at least about 1.1 mm. However, a screw with a shaft outer diameter of at least 2.8 mm can provide enough space for a cruciate fixation pattern (also called a "cruciate pattern") in small bones such as the phalanges. To provide more space, the wall thickness of the shaft of the screw can be trimmed or reduced, for example from about 2.8 mm to less than 2.5 mm, but the trimmed screw may not have enough length to achieve bicortical retention in the phalanges when implanted in a cruciate fixation pattern. This is because the maximum allowable screw length depends on the shank thickness of the screw. Longer screws require a larger wall thickness to maintain the structural rigidity and strength of the screw.

[0106] The present disclosure provides an exemplary system of cruciate fixation implants that can be threaded and / or cannulated while having desired dimensions suitable for intramedullary fixation of phalanges (and other ossicles), including having bicortical retention and improved rotational control. The present disclosure also provides exemplary instruments including, but not limited to, customized guidewires with at least two diameters to allow easier sizing of the fixation implant length and easier delivery of the implant. Exemplary Intramedullary Fixation Systems

[0107] Figures 2A-2F show a non-limiting example orthopedic implant 100 of the present disclosure. Figures 3A and 3B show a blank version of the implant 100 of Figures 2A-2F. The blank is shown without the threads to more clearly show certain features of the implant 100.

[0108] The implant 100 can be formed of any suitable material, such as titanium, stainless steel, or other metals and / or alloys. As shown, the implant 100 can have a leading end 102 and a trailing end 104. The overall length between the leading end 102 and the trailing end 104 can be, for example, about 10 mm to about 50 mm, or about 12 mm to about 48 mm, or about 20 mm to about 48 mm, or about 24 mm to about 46 mm, or about 28 mm to about 44 mm, or about 32 mm to about 42 mm, or about 36 mm to about 40 mm.

[0109] The implant 100 can include a through cannula 120 along its longitudinal axis A for receiving a delivery guidewire (e.g., guidewire 400 of FIGS. 4A-4C, described in more detail below). The through cannula 120 can have an inner diameter that can be, for example, less than about 1 mm, or between about 0.80 mm and about 0.96 mm, or between about 0.84 mm and about 0.94 mm.

[0110] The shaft 106 can extend from the leading end 102 towards the trailing end 104. As shown in FIG. 3A, the shaft 106 can have a generally uniform outer (or major) diameter D, except for the leading portion 108 (see also FIG. 2F). The outer diameter D can be less than about 2.5 mm, or less than about 2.4 mm, or less than about 2.2 mm, or less than about 2.1 mm, or less than about 2.0 mm. The leading portion 108 can taper from the outer diameter D to a smaller diameter. The leading portion 108 can have a length, for example, less than about 2 mm, or less than about 1.5 mm. As shown in FIG. 2A, the leading portion 108 can include one or more cutting features 110, e.g., one or more cutting grooves. The taper and / or cutting features of the leading portion 108 can facilitate easier insertion of the implant 100 into bone, for example, into a preformed tunnel in the bone.

[0111] The driver head 112 can be located at the rear end 104, adjacent to the shaft 106. The driver head 112 can be, for example, less than about 4.0 mm, or less than 3.5 mm. As shown in FIGS. 2E and 3A, the driver head 112 can include a tapered section 114 that transitions from the outer diameter of the driver head 112 to the outer diameter D of the shaft 106. The outer diameter of the driver head 112 can be, for example, less than about 3.0 mm, or between about 2.5 mm and about 3.0 mm, or between about 2.6 mm and about 2.9 mm. As shown in FIG. 2A, the driver head 112 can include one or more cutting features 116, for example, one or more cutting grooves that can be located mostly or at least partially within the tapered section 114.

[0112] The driver head 112 can include a driver interface, for example, a hexagonal interface 118 as shown in FIG. 2C. The hexagonal interface 118 can include an inner diameter that is larger than the outer diameter of the through hole 120. The driver interface can allow for the transfer of torque from a driver (e.g., the driver 600 of FIGS. 6A-6D, described in more detail below) to the implant 100 for delivery of the implant 100 into the bone. Alternatively, the driver interface can be a slot interface 718 in a driver head 712 of the implant 700 as shown in FIGS. 7A-7D. The implant 700 can include any of the features of the implant 100 disclosed herein and will not be repeated here for brevity. Alternatively, the driver interface can accept any other suitable driver configuration, for example, a Torx drive, Pozidriv, Robertson, Tri-Wing, Torq-Set, SpannerHead, Triple Square, etc.

[0113] The implant 100 can be threaded. As shown in FIGS. 2A and 2B, threads 122 can extend along the entire length or substantially the entire length of the shaft 106. The threads 122 can also optionally extend (completely or at least partially) along the driver head 112. The thread height can be lower at the driver head 112 than at the shaft 106. The shaft 106 can have a uniform thread height such that the shaft can have a substantially uniform root or minor diameter. The threads 122 along the shaft 106 can have any suitable thread height (e.g., about 0.15 mm to about 0.30 mm, or about 0.20 mm to about 0.25 mm, or the like) and / or pitch (e.g., about 0.5 mm to about 1.0 mm, or about 0.7 mm to about 0.8 mm, or the like). The threads 122 can have a substantially constant pitch or alternatively a varying thread pitch. Thus, the implant 100 may be a non-compressed implant, or may be a compressed implant where compression is indicated, such as in fixation of a transverse midshaft fracture. The aforementioned cut grooves in the anterior portion 108 and driver head portion 112 may interrupt the threads 122, making the threads 122 discontinuous and optionally serrated at the cut grooves. The interruption and / or serrations of the threads 122 at the cut grooves may facilitate delivery of the implant 100 into the bone. Alternatively, the implant 100 may be unthreaded. Unthreaded implants may optionally have a protruding portion protruding from the outer surface of the implant to improve bone retention. The surface may include other features such as spikes, ridges, barbs, uneven or rough surfaces, etc.

[0114] A non-limiting example of a guidewire 400 for delivering an implant 100, 700 (or variations thereof according to the present disclosure) is shown in Figures 4A-4C. The guidewire 400 can be made of any suitable material, for example, the same material as that of a standard K-wire. The guidewire 400 can include a leading end 402 and a trailing end 404. The leading end 402 of the guidewire 400 can include a sharpened tip 412, which can be, for example, a trocar tip with a three-sided cut tip as shown in Figure 4C, or can have any other shape. The sharpened tip 412 can facilitate easier insertion of the guidewire 400 into the bone via the leading end 402.

[0115] The guidewire 400 can include a first portion 406 having a first substantially uniform diameter D1 and a second portion 408 having a second substantially uniform diameter D2. The first portion 406 can be proximate the trailing end 404 and the second portion 408 can be proximate the leading end 402. The first portion 406 can extend from the trailing end 404 to. A transition portion (also referred to herein as a "wire shoulder") 410 can join the first portion 406 and the second portion 408. In some implementations, the transition portion 410 can have a zero length such that the first portion 406 transitions into the second portion 408 with a gradual transition.

[0116] D1 may be configured such that the first portion 406 can slidably receive the implant 100 through the through-tubing portion 120. D1 may be, for example, less than about 1 mm, or less than about 0.8 mm, or about 0.7 mm to about 0.8 mm. D2 is preferably greater than D1 and is greater than the inner diameter of the through-tubing portion 120. D2 may be similar or substantially the same as the outer diameter D of the implant 100. D2 may be, for example, greater than about 1 mm, or greater than about 1.1 mm, or about 1.2 mm to about 2.5 mm, or about 1.5 to about 2.0 mm.

[0117] The guidewire 400 can be inserted into a bone in a fracture fixation procedure via the leading end 402, which can include a sharp tip 412. Once the second portion 408 of the guidewire 400 extends through the bone, the length of the second portion 408 embedded in the bone can be measured directly or indirectly to determine the length of the implant 100 to be used such that neither end of the implant 100 protrudes beyond the outer surface of the bone.

[0118] The first portion 406 may have a length greater than that of the implant 100 to slidably receive the implant 100 and allow easier manipulation of the rear end 404 of the guidewire 400 and / or easier interfacing of the driver with the driver interface 118 on the rear end 104 of the implant 100. The length of the first portion 406 may be, for example, about 30 mm to about 60 mm, or about 35 mm to about 55 mm, or about 40 mm to about 45 mm. The second portion 408 may have a length greater than sufficient to extend between the two sides of the outer surface of the cortical wall. The length of the second portion 408 may be sufficient for easier sizing of the implant length required when the second portion 408 is inserted into the bone. The length of the second portion 408 may be, for example, about 30 mm to about 70 mm, or about 40 mm to about 65 mm, or about 50 mm to about 60 mm.

[0119] The necessary or desired length of the implant 100 can be determined using a sizing tool that can directly or indirectly measure the desired length of the implant 100. One example of a sizing tool is a depth gauge 500 as shown in FIGS. 5A-5D. The depth gauge 500 can be made of any suitable material, such as stainless steel, a biocompatible plastic, or others. The depth gauge 500 may optionally be disposable. A disposable depth gauge does not need to be sterilized for reuse. For example, it can be autoclaved. The sterilization process by sterilization can also distort the shape of the depth gauge 500, thereby rendering the depth gauge 500 inaccurate.

[0120] The depth gauge 500 can include a tip portion 502 and a gradation portion 504. As shown in FIG. 5, the tip portion 502 can have a smaller dimension than the gradation portion 504 in one view. For example, the gradation portion 504 can gradually taper toward the tip portion 502. As shown in FIGS. 5B and 5C, the depth gauge 500 can have a generally uniform thickness, which can be in the millimeter range, for example. The length of the depth gauge 500 or a portion thereof, such as the distance of the depth gauge 500 from the free end of the tip portion 502 to the first gradation mark 506, can vary depending on the length of the second portion 408 and / or the overall length of the guidewire 400.

[0121] As described in more detail below, in use, the free end of the tip 502 can be positioned flush with the insertion point of the guidewire 400 on the outer surface of the bone. The depth gauge 500 can include an elongated slot 508 that extends generally along the longitudinal axis CL of the depth gauge 500 for a portion of the depth gauge 500. As shown in FIGS. 5A and 5D, the slot 508 can terminate past a final gradation mark 510 near the free end of the gradation section 504. The remaining portion of the guidewire 400 outside the insertion point on the bone can be aligned generally along the slot 508. A gradation mark (e.g., numbers, letters, icons, etc., such as 48, 46, 44, etc.) aligned with the beginning of the transition section 410 can indicate the desired length (e.g., in mm) of the implant 100. As shown in FIG. 5A, instructions on how to read the measurements can be provided on the surface of the depth gauge 500 to reduce confusion regarding the proper use of the depth gauge 500.

[0122] Alternatively or additionally, other types of depth gauges can be used. For example, a depth gauge similar to depth gauge 500 can measure the distance of guidewire 400 from the insertion point on the bone to the rear end 404 of guidewire 400. Such a depth gauge can have a longer overall length than depth gauge 500, as shown in FIGS. 5A-5D. Alternatively, guidewire 400 itself can include multiple depth marks so as not to require a separate sizing tool. In some configurations, the depth mark on such a guidewire closest to the insertion point on the bone can indicate the desired length of implant 100. In some embodiments, the depth marks on the portion of the guidewire embedded in the bone can be radiopaque so as to be visible when viewed using fluoroscopy.

[0123] 6A-6D show an exemplary driver 600 configured to deliver the implant 100. The driver 600 can include a driver handle 602 and a driver shaft 604. The driver handle 602 and / or the driver shaft 604 can be formed from any suitable material(s), such as stainless steel, a biocompatible plastic, or otherwise. The driver shaft 604 can be coupled to the handle 602 using any suitable method, such as via one or more dowel pins 606 as shown in FIGS. 6A and 6B, overmolding, or otherwise.

[0124] 6C and 6D show a head portion 608 of the driver shaft 604. The head portion 608 is configured to interface with the driver interface 118 of the implant 100. In the example shown, the head portion 608 can be a hexagonal head that matches the hexagonal head interface of the implant 100. The head portion 608 can have other configurations depending on the type of driver interface of the implant.

[0125] As shown in FIG. 6D , at least the head portion 608 of the driver shaft 604 can be cannulated. In some configurations, the driver 600 can be cannulated along its entire length or substantially its entire length. The diameter of the cannulation portion 610 can be set such that the cannulation portion 610 can slidably receive the first portion 406 of the guidewire 400 during an implant delivery procedure for mating with the implant 100, which also slidably receives the first portion 406 of the guidewire 400. The diameter of the cannulation portion 610 can be the same or substantially similar to the diameter of the through cannulation portion 120 of the implant 100, for example. Exemplary Delivery Methods of the Intramedullary Fixation Systems Disclosed herein

[0126] Certain steps of a preferred exemplary method of delivering the implant 100,700 (or any variation thereof based on the present disclosure) are illustrated in Figures 8A-8F.

[0127] As shown in FIG. 8A, the body anatomical structure including the injured bone can be viewed using an imaging system, which can be, for example, fluoroscopy using a C-arm or the like. As shown in the X-ray image of FIG. 8A, a bone 6, which can be, for example, a phalange, sustains a fracture at a fracture site 22. As shown in FIG. 8B, a first guidewire 400 having at least two diameters can be inserted from a front end 402 into the medullary canal of the bone 6. A second portion 408 of the guidewire 400 is inserted partially into the bone. The guidewire 400 can be percutaneously inserted into the non-articular base of the bone (or the non-articular surface proximal to the base). The guidewire 400 can be inserted, for example, in a proximal to distal direction. After entering the bone 6, the guidewire 400 can traverse the bone medially and laterally (or laterally and medially) and can traverse the fracture site 22.

[0128] 8C, the advancement of the guidewire 400 can be stopped when the leading end 402 of the guidewire 400 is flush, substantially flush, or slightly proximal to the outer surface 20 of the bone 6 on the opposite side of the medullary canal 9 from the insertion point 24. The location of the leading end 402 of the guidewire 400 within the bone 6 can be confirmed using an imaging system. The length of the second portion 408 of the guidewire 400 within the bone 6 can be measured using any suitable dimensioning marks, tool, or the like.

[0129] For example, a small incision (e.g., about 2 mm) can be made in the skin over the bone 6. The tip 502 of the depth gauge 500 can be inserted into the small incision. In the example shown in FIG. 8C, the free end of the tip 502 of the depth gauge 500 can be placed flush over the insertion point 24 of the guide wire 400 on the bone 6. The guide wire 400 and / or the depth gauge 500 can be adjusted so that the guide wire 400 is visible within the elongated slot 508 and extends substantially parallel to the slot 508. A graduated mark aligned with the transition 410 of the guide wire 400 can provide an indication of the desired implant length so that, when implanted, the implant 100 can engage both cortical walls of the bone 6 but not protrude beyond the outer surface 20 of the bone on either end of the implant 100. As shown in FIG. 8C, the transition 410 can be aligned with the 45 mm gradation mark. An implant can be selected having a length of about 45 mm or the next closest available length not exceeding 45 mm (e.g., 44 mm). After the implant 100 is sized, the depth gauge 500 can be removed.

[0130] As shown in FIG. 8D, the guidewire 400 can be advanced further through the bone 6 until the transition section 410 substantially reaches the insertion point 24 of the bone. A first cannulated implant 100 having a desired length, for example, a desired length of about 44 mm to about 45 mm in the illustrated example, can be slid onto the first portion 406 of the guidewire 400. The first implant 100 can stop advancing over the first portion 406 of the guidewire 400 once the first implant 100 reaches the transition section 410. The at least partially cannulated driver 600 can also be slid onto the remaining portion of the first portion 406 of the guidewire 400 via the rear end 404 of the guidewire 400.

[0131] The driver 600 can be advanced along the first portion 406 of the guidewire 400 until the driver head 608 of the driver 600 engages the driver interface of the implant 100 on the rear end 104 of the implant 100. Alternatively, the implant 100 and the driver 600 can be removably connected before being advanced over the guidewire 400. Using the driver 600, the implant 100 can be delivered through the bone tunnel formed by the second portion 408 of the first guidewire 400. The root or minor diameter of the shaft 106 of the implant 100 can be substantially the same as the outer diameter D2 (see FIG. 4B) of the second portion 408 of the guidewire 400. Thus, the second portion 408 of the guidewire 400 can clear a path for the root or minor diameter of the shaft 106 of the implant 100. Alternatively, the outer diameter D2 can be substantially the same as the outer or major diameter D of the shaft 106 of the implant (see FIG. 3A). Due to the at least two diameters D1, D2 (see FIG. 4B) of the guidewire 400, the implant 100 can have a larger wall thickness relative to the length of the implant 100, and therefore a larger structural rigidity, while keeping the outer diameter D small, only slightly larger than D2 of the second portion 408 of the guidewire 400. The at least two diameters of the guidewire 400 allow the second portion 408 of the guidewire 400 to be used to form a bone tunnel, such that the implant 100 can be driven into the bone 6 using a smaller torque and / or the insertion of the implant 100 causes little or no additional trauma to the bone 6 than the insertion of the guidewire 400. If greater resistance is felt during insertion of the implant 100, the driver 600 can be retracted a few turns (e.g., about 2 turns) before resuming insertion of the implant 100.

[0132] The placement of the implant can be intermittently (or continuously) verified over an imaging system. The thread pitch of the implant 100 can be set to allow finer and more precise control of the advancement distance of the implant 100 in the bone 6 by rotating the driver 600 than is possible when advancing a standard K-wire into the bone by axial advancement of a K-wire driver. The greater control by the driver 600 can allow the implant 100 to be more precisely placed in the bone 6 and can further reduce the chance of the leading end 102 or trailing end 104 of the implant 100 penetrating into the tissue surrounding the bone 6.

[0133] 8E, after the first implant 100 is implanted in the bone 6 at a desired location, the first guidewire 400 can be removed from the first implant 100 and the bone 6. For example, the first portion 406 of the first guidewire 400 can be distally removed. Because D1 of the first portion 406 of the guidewire 400 is less than D2 of the second portion 408 of the guidewire 400, pulling the first portion 406 of the guidewire 400 out of the bone 6 does not cause any further trauma to the bone 6.

[0134] The same steps can be repeated with the same guidewire 400 or a second guidewire 400 to deliver a second implant 100. The second implant 100 may or may not be the same length as the first implant. As shown in FIG. 8E, a second portion 408 of the same or second guidewire 400 can be inserted into a different insertion point 26 on the non-articular base of the bone 6 in an orientation such that the guidewire 400 can traverse the first implant 100 and its leading end 402 can terminate on the cortical wall opposite the cortical wall engaged by the leading end 102 of the first implant 100.

[0135] As shown in Fig. 8E, when the second implant 100 is implanted over the guide wire 400, it can be ensured that the guide wire 400 and the first implant 100 are separated by a minimum distance to ensure that the threads of the second implant 100 do not come into contact with the outer surface of the first implant 100, as such contact during insertion of the second implant 100 would transmit higher torque values ​​to the driver 600, potentially causing the driver 600 to fail.

[0136] After the second implant 100 has been implanted in the bone 6 to the desired position, the same or second guide wire 400 can be removed from the second implant 100 and the bone 6 as described above. Figures 8F and 8G show X-ray images of the implanted cross-fixed first and second implants 100 as viewed from above or below the fractured bone 6 (Figure 8F) and from the inside or outside of the fractured bone (Figure 8G). Neither end of either implant 100 is positioned protruding from the outer surface 20 of the bone 6 to avoid interaction with the tissue surrounding the bone 6. The first and second implants 100 are crossed to improve rotational control of the fractured portion of the bone relative to each other.

[0137] The delivery method of the intubation implant 100 using a guidewire 400 having at least two diameters may also benefit from employing some of the same techniques as the standard K-wire cruciate fixation described above. Surgeons are likely already trained and familiar with cruciate fixation techniques, making the systems and methods disclosed herein safer and more efficient to perform. However, the fixation systems and methods disclosed herein further improve upon standard K-wire cruciate fixation by, for example, allowing for more accurate sizing of the implant, reducing post-operative implant displacement, and providing other advantages disclosed herein.

[0138] The implant 100 may also be implanted using different delivery methods as illustrated in Figures 9A-9H. Alternative methods may include any of the associated steps previously described, such as, for example, imaging the bone, the implant 100, and / or a delivery tool including the guidewire 400, inserting the guidewire 400, sizing the implant 100, and / or inserting the first and second implants 100 using the guidewire 400. Features in the description of Figures 9A-9H may also be incorporated into the methods previously described.

[0139] As shown in FIG. 9A, another implantation procedure can include inserting a first guidewire 400 having at least two diameters and a second guidewire 400 having at least two diameters in a cross pattern prior to inserting either implant 100. A predetermined distance between the second portions 408 of the first and second guidewires 400 can be confirmed using an imaging system to reduce the possibility of the two implants 100 contacting each other during insertion. As shown in FIG. 9B, the second portion 408 of the guidewire 400 can be withdrawn from the bone 6 to leave the first portion 406 of the guidewire 400 in the bone in a tunnel formed by the insertion of the second portion 408.

[0140] As shown in FIG. 9C, the first implant 100 can be inserted by the driver 600 into the bone tunnel formed by the second portion 408 of the guidewire 400, guided by the first portion 406 of the guidewire 400. As shown in FIG. 9D, the driver 600 can be removed after the first implant 100 has been delivered to the desired location. FIGS. 9E and 9F show repeating the steps of FIGS. 9C and 9D to insert the second implant 100 guided by the second guidewire 400. Once both implants 100 have been delivered to their respective desired locations, the first and second guidewires 400 can be removed from the first and second implants 100 and the bone 6.

[0141] Alternatively, after the step shown in Figure 9A, the first and second guidewires 400 can be advanced further into the bone until the transition portions 410 of the first and second guidewires 400 are adjacent the insertion points on the bone, similar to the step shown in Figure 8D for a single guidewire 400. The first and second implants 100 can then be inserted into the bone along with the first portions 406 of the first and second guidewires 400, as previously described.

[0142] As another alternative as shown in FIG. 10, a first implant 100 and a second implant 100 can be inserted into a bone 6 having a fracture 22 such that the first and second implants 100 are substantially parallel to each other. Neither end of the first implant 100 nor the second implant 100 protrudes beyond the outer surface 20 of the bone 6. The first and second implants 100 may or may not be of the same length. This method can incorporate any of the steps of the methods described above. For example, the first and second implants 100 can be inserted using one or more guidewires, such as the guidewire 400 disclosed herein. If a separate guidewire is used for each implant 100, the guidewires can both be inserted substantially parallel to each other into the bone 6 prior to the insertion of the first and second implants 100 guided by the guidewires. Alternatively, the second guidewire can be inserted after the insertion of the first implant 100 guided by the first guidewire. The first guidewire can be removed or can remain in the bone 6. The second guidewire can be inserted substantially parallel to the implanted first implant 100. Alternatively, using the methods disclosed herein, two or more implants 100 can be inserted into the patient's bone in any orientation relative to one another. EXAMPLES OF METHODS FOR DELIVERY OF A LAG SCREW USING THE SURGICAL INSTRUMENTS DISCLOSED HEREIN

[0143] The above surgical instruments can alternatively or additionally be used to deliver different types of implants, such as, but not limited to, lag screws. One or more lag screws and lag techniques can compress fractured bone fragments together to achieve fixation at the fracture site and promote healing. Lag screws can be used for various types of fractures, including, but not limited to, avulsion fixation, mallet fracture fixation, distal uni / bicondylar fixation, spiral / oblique fixation, Rolando fracture fixation, and Bennett fracture fixation. Lag screws can be used to fix different types of bones, such as the phalanges shown in Figures 11A-11B and the metacarpals shown in Figure 11C.

[0144] Conventional lag screw implantation techniques may include pre-drilling through the near and far cortices of the bone using a reamer. When the screw is tightened, the threads on the end of the screw engage the far cortex and the head of the screw engages the near cortex, compressing the fracture fragments together. In addition to requiring a dedicated reamer to form the bone tunnel, conventional lag screw implantation techniques may have several other challenges. As shown in FIG. 12A, it may be difficult for the surgeon to find the far cortex with the tip of the lag screw when inserting the lag screw (without being cannulated) through the bone tunnel formed by the bone reamer. As shown in FIG. 12B, a glide hole is necessary when the lag screw is substantially threaded throughout its entire shaft length. The step of forming a glide hole is also referred to as over-drilling. As shown in FIG. 12B, the near cortex is over-drilled using a first reamer to the larger outer diameter of the screw shaft to form a glide hole before the far cortex is drilled using a second smaller size reamer to a diameter similar to the smaller diameter of the screw shaft. When the screw is inserted, it glides through the glide hole and the threads engage only the far cortex through the thread hole. Over-drilling is an extra drilling step that can make the injection procedure more complicated. The additional step can also increase the risk of iatrogenic damage or wounds. As shown in FIG. 12C, when an intubating lag screw is used, a conventional K-wire is first inserted through the near and far cortex before the reamer is introduced. However, the K-wire may be pulled out or slip out during the procedure (e.g., when the first reamer for the over-drilling is removed) in the direction indicated by the arrow and need to be reintroduced, which can complicate the procedure. Furthermore, as shown in FIG. 12D, due to the small outer diameter of the conventional K-wire as mentioned above, the K-wire may bend during insertion into the bone, making it difficult to use to introduce the intubating lag screw.

[0145] Delivering a lag screw using the surgical instruments disclosed herein, particularly the guidewire 400 of FIGS. 4A-4C, can address some of the aforementioned challenges and others. As shown in FIG. 13, an exemplary lag screw 1300 can be delivered using the guidewire 400. The lag screw 1300 can be made of stainless steel, titanium, hard plastic, or the like. The lag screw 1300 can include a head 1302 and a shaft 1304. The head 1302 can be a hexagonal drive head or other. The head 1302 can have a larger outer diameter or larger diameter than the shaft 1304. The shaft 1304 can have a small diameter D1. The shaft 1304 can be threaded at its distal end 1306. In some embodiments, the shaft 1304 can be fully threaded. The distal end 1306 can have a large diameter D2. The lag screw 1300 may be cannulated to allow the screw 1300 to slide over the first portion 406 of the guidewire 400. The outer diameter of the first portion 406 of the guidewire 400 may be, for example, about 0.6 mm, or any other value disclosed herein. The minor diameter D1 of the shaft 1304 of the lag screw 1300 may be substantially the same as the outer diameter of the second portion 408 of the guidewire 400. As described below with reference to Figures 14A-14E, the path of the minor diameter D1 of the shaft 1304 of the lag screw 1300 may be prepared by the second (i.e., larger diameter) portion 408 of the guidewire 400. The outer diameter D1 and / or the second portion 408 of the screw 1300 may be, for example, about 1.1 mm. The outer diameter of the thread of the screw 1300 may be greater than 1.1 mm, for example, about 1.5 mm. The length of the screw 1300 may be from about 6 mm to about 22 mm, or from about 7 mm to about 21 mm, or from about 8 mm to about 20 mm, or from about 9 mm to about 19 mm, or from about 10 mm to about 18 mm, etc. The screw 1300 may be available in different lengths.

[0146] Certain steps of an exemplary method of delivering the lag screw 1300 (or any other lag screw) are shown in FIGS. 14A-14E. This method does not include the use of a cannulation drill as in conventional cannulation lag screw implantation procedures. While there is no need to pre-drill before introducing the guidewire 400 into the bone 6, most conventional cannulation screw systems require the use of a guidewire and a separate cannulation drill. Some systems can eliminate the cannulation drilling step by using a cutting groove feature at the tip of the screw so that the screw is self-drilling or self-tapping, but those systems are still limited to K-wires with very small diameters for initial targeting. When the cannulation screw slides over and is guided by the K-wire during insertion into the bone, the outer diameter of such K-wires is limited by the size of the cannulation section of the screw. Also, as previously mentioned, K-wires with small diameters can flex or bend during insertion into the bone and therefore can be difficult to use for initial targeting. In comparison, guidewire 400 includes a second portion 408 that has a larger outer diameter at the leading end 402 (and clears the way for the screw). The outer diameter of second portion 408 is larger than the size of the cannulated portion of the screw. Second portion 408 bends less than a conventional K-wire, is stiffer, and is more easily inserted into the bone. A screw can then be slid over first portion 406 of guidewire 400 with the smaller outer diameter inserted into the bone.

[0147] As shown, bone 6, which may be, for example, a phalange, sustains a fracture at fracture site 22. A guidewire 400 may be inserted into bone 6 from a leading end 402. Insertion of guidewire 400 may be aided by a suitable guidewire driver 1400. Guidewire driver 1400 shown in FIGS. 14A, 14C, and 14D is for illustrative purposes only and is not limiting. Guidewire driver 1400 drives guidewire 400 through fracture site 22. 400。 Guidewire driver 1400 may include a handle 1402 for a user's hand to facilitate pushing and / or pulling the guidewire 400. Guidewire driver 1400 may include a collet or collet system to grip the second portion 408 of guidewire 400. Guidewire driver 1400 may not need to have a dedicated retrieval or collet system to grip the thinner first portion 406 of guidewire 400. Thinner first portion 406 may be too small to engage with an off-the-shelf collet.

[0148] As shown in FIG. 14B, the second portion 408 of the guidewire 400 can be partially inserted into the bone 6 to a desired final implant depth, penetrating at least the near cortex 24 of the bone 6. As shown in FIG. 14B, the leading end 402 of the guidewire 400 is just about to penetrate the bone surface of the far cortex 26. The location of the leading end 402 of the guidewire 400 within the bone 6 can be confirmed using an imaging system. The guidewire driver 1400 can be temporarily disengaged from the guidewire 400, and the desired length or size of the lag screw can be determined using the depth gauge 500 described above with reference to FIG. 8C. After the lag screw has been sized, the depth gauge 500 can be removed. The length of the second portion 408 of the guidewire 400 within the bone 6 can be measured using any suitable sizing marks, tool, or the like. As shown in FIG. 14C, the guidewire driver 1400 can re-engage the guidewire 400 to continue to advance the leading end 402 of the guidewire 400 in the direction of the arrow through the far cortex 26 of the bone.

[0149] 14D , the guidewire driver 1400 can be disengaged from the second portion 408 of the guidewire 400 at the near cortex 24 and reengaged with the second portion 408 of the guidewire 400 at the far cortex 26 of the bone 6. The guidewire driver 1400 can be pulled away from the bone 6 to pull the guidewire 400 and pull the first portion 406 of the guidewire 400 toward the near cortex 24 of the bone 6.

[0150] 14E, the guidewire driver 1400 can be pulled away from the bone 6 to pull the guidewire 400 until the first portion 406 of the guidewire 400 enters the bone 6 from the near cortex 24. The guidewire driver 1400 can be removed from the guidewire 400. A lag screw 1300 having a desired length determined using a depth gauge or other method can be slid onto the first portion 406 of the guidewire 400. A driver 600, at least partially intubated as described above, can be slid over the remaining portion of the first portion 406 of the guidewire 400 via the trailing end 404 of the guidewire 400. The driver 600 can be advanced along the first portion 406 of the guidewire 400 until the driver head 608 of the driver 600 engages the driver interface of the lag screw 1300 on the head 1300 of the lag screw 1300. Alternatively, the lag screw 1300 and the driver 600 can be removably connected before being advanced over the first portion 406 of the guidewire 400. As previously mentioned, the minor diameter of the shaft 1304 of the lag screw 1300 can be approximately the same as the outer diameter of the second portion 408 of the guidewire 400. Using the driver 600, the lag screw 1300 can be delivered through a tunnel in the bone formed by the second portion 408 of the first guidewire 400. The threaded end 1306 of the screw 1300 can engage the far cortex 26 and the head 1302 of the screw 1300 can engage the near cortex 24 to compress the fracture fragments together. Screw placement can be intermittently (or continuously) confirmed using an imaging system. Alternatively, a driver different from the driver 600 of FIG. 14E can be used to drive the screw 1330 into the bone 6.

[0151] As shown in Figures 14A-14E, delivering the lag screw 1300 using an instrument including at least a guidewire 400 can eliminate the need for a pre-drilling step and a separate reamer (or drill) and / or the need for a special collet for the K-wire driver to engage a conventional K-wire having a small outer diameter (e.g., less than about 0.7 mm). The delivery method shown in Figures 14A-14E can eliminate K-wire pullout after over-drilling, especially when switching to a different size reamer, and can maintain bone reduction by holding the guidewire 400 in place while advancing the screw 1300. Additionally, the larger diameter second portion 408 of the guidewire 400 is stiffer, less likely to bend, and easier to insert into the bone 6 than a conventional K-wire having a smaller outer diameter.

[0152] By eliminating the need for reamers or drills, which are generally reusable and sterilized after each use, it becomes possible to prepackage the surgical instruments and / or screws or any other implants disclosed herein into a sterile (and optionally disposable or single-use) kit. As shown in FIG. 15, a packaged kit 1500 can include a sterile surgical instrument package 1502 and a sterile implant package 1504. The sterile surgical instrument package 1502 can include a guidewire 400, a driver 600, and a depth gauge 500. The guidewire 400, the driver 600, and / or the depth gauge 500 can be single-use or reusable. In order to reuse the guidewire 400, the driver 600, and / or the depth gauge 500, these instruments can be resterilized after each use.

[0153] Stepped or dual diameter guidewires, such as the guidewire 400 of FIGS. 4A-4C, can provide flexibility in surgical techniques depending on the preferences of the user (e.g., surgeon). For example, in a Jones fracture fixation or another fracture fixation procedure, the user may prefer a cannulation technique, but a solid screw to increase implant strength. By having a stepped guidewire with a larger diameter leading end that prepares the implant pathway with a connected smaller diameter trailing end that allows for the insertion of a cannulation device, both solid and cannulation techniques can be enabled. In the case of a solid technique, the solid screw can include a small recess and / or be partially cannulated at the leading end to interact with the thinner portion of the dual diameter guidewire disclosed herein. Additionally, a stepped guidewire can provide the ability to insert a cannulation screw with a larger wall thickness (smaller diameter cannulation section) with a strength closer to the strength of a solid screw than a cannulation screw with a larger cannulation diameter.

[0154] The lag screw 1300 disclosed herein can be used in other applications. For example, as shown in FIG. 16, multiple lag screws 1330, which can be delivered using the instruments disclosed herein, such as the guide wire 400, can be used in combination with an intramedullary nail for fractures. The intramedullary nail 1400 can be threaded and can include a first section having a first major diameter and a second section having a second major diameter. There can be a transition between the first section and the second section. The transition can have a major diameter that changes from the first major diameter to the second major diameter. Further details of the intramedullary nail 1600 are described in International Patent Application Publication No. WO 2019 / 050833, published March 14, 2019, which is incorporated herein by reference in its entirety. The combination of the lag screw 1300 and the intramedullary nail 1400 can be used for fixation in more complex fracture cases. As shown in Figures 17A-17B, the instruments and delivery methods disclosed herein can deliver lag screws for fracture fixation not only to the hand as shown above, but also to the metatarsals (Figure 17A) and phalanges (Figure 17B) of the foot. Exemplary Alternative Delivery Tool to Stepped Guidewires

[0155] As an alternative to the stepped guidewire 400 of Figures 4A-4C and the method of using the guidewire 400 disclosed herein, further tools and methods for introducing a cannulated implant (e.g., cannulated implant 100, lag screw 1300, intramedullary nail as described in WO 2019 / 050833, or other methods), partially cannulated implant, or non-cannulated implant are described with reference to Figures 18-25B. The alternative examples described below are not limiting. Features of any one of the various examples described below can be combined with or incorporated into features of another one of these examples.

[0156] The stepped guidewire 400 of Figures 4A-4C and alternative examples described below with reference to Figures 18-25B can be used to deliver any threaded (any helical thread regardless of pitch size) or partially threaded implants, such as the exemplary orthopedic implants 100 and lag screws 1300 disclosed herein, and / or any other elongated implants that may not necessarily include threads, but may include one or more protrusions on the shaft of the implant. If the implant is fully or partially threaded, the threads can have any pitch size. The one or more protrusions can include barbs, fins, ridges, etc. The one or more protrusions can have any shape or size. Partially or fully threaded implants can be driven into the bone by rotation. Non-threaded implants can be driven into the bone by press fit.

[0157] 18A-18B show steps of using a cannulation drill 1800 to deliver a cannulation implant. All of the drills shown in FIGS. 18-25B can include a guidewire having a larger outer diameter (e.g., substantially similar to the small diameter of the shaft of the implant used for fracture fixation) than a conventional K-wire. As shown in FIG. 18A, in a first step, the cannulation drill 1800 can be inserted into the bone 6 across the fracture line 22 in the direction shown by arrow 1. The insertion of the cannulation drill 1800 can provide an implant pathway in the bone 6. As shown in FIG. 18B, in a second step, a K-wire 1810 having a smaller outer diameter can be inserted into the cannulation portion of the cannulation drill 1800 in the direction shown by arrow 2. In a third step, the cannulation drill 1800 can be removed along the direction shown by arrow 3, with the K-wire 1810 remaining in the implant pathway to maintain the reduction of the fracture and provide a guide for embedding the cannulation implant over the K-wire 1810.

[0158] FIG. 19 shows a drill or guidewire 1900 including a wire loop 1902 attached to a rear end 1904 of the drill 1900 (opposite a drilling tip that may include a trocar or any other sharp tip). The drill 1900 cannot be cannulated or is substantially cannot be cannulated. The drill 1900 can be inserted into the bone 6 across the fracture line 22 to provide an implant channel in the bone 6. A corresponding K-wire 1910 having a smaller outer diameter than the drill 1900 can include a hook 1912. The hook 1912 can engage with the wire loop 1902 such that when the drill 1900 is pulled through the implant channel on the far side of the bone 6, the K-wire 1910 can be pulled through the implant channel following the drill 1900 into the bone 6. After the drill 1900 is removed, the K-wire 1910 can remain in the implant channel to maintain reduction of the fracture and provide a guide for embedding a cannulated implant over the K-wire 1910. The drill 1900 can be disengaged from the K-wire 1910 by removing the hook 1912 from the wire loop 1902. The configuration shown in FIG. 19 can be reversed so that the hook is on the rear end 1904 of the drill 1900 and the loop is on the K-wire 1910. Optionally, the connection point between the hook and loop can be crimped to reduce the chance of cuts between the hook and loop as the drill 1900 is pulled through the bone 6.

[0159] As shown in FIG. 20, a guidewire 400 similar or substantially the same as the guidewire 400 previously described can be used to deliver an implant 2000 including a blind hole 2002 (rather than a through cannulation) at its leading end 2004. In other words, the implant 2000 can have any of the features of the implant 2000 or the lag screw 1300, except that the implant 100 is not fully cannulated. The blind hole 2002 can be sized to slidably receive the thinner first portion 406 of the guidewire 400. The implant 2000 can be engaged with the thinner first portion 408 of the guidewire 400 after the thicker second portion 406 has been inserted into the bone or bone fragment to prepare an implant pathway within the bone or bone fragment. After the implant 2000 is engaged with the guidewire 400 at the blind hole 2002, the driver 600 disclosed herein or any other suitable driver (e.g., a non-cannulated driver) can be used to insert the implant 2000 into the bone for fracture fixation.

[0160] The thicker second portion and the thinner first portion of the guidewire disclosed herein can be removably connected to deliver a cannulated implant during fracture fixation. FIGS. 21A and 21B show a partially cannulated drill 2100 including a blind hole 2102 at its rear end 2104. The outer diameter of the drill 2100 can be approximately the same as the outer diameter of the second portion 408 of the guidewire 400 described above. The blind hole 2102 can receive a K-wire 2110 having a smaller diameter (e.g., any conventional prefabricated K-wire having an outer diameter less than about 0.7 mm). Once the drill 2100 is inserted into the bone to prepare the implant and pulled through the implant passage on the far side of the bone, the K-wire 2110 can be pulled into the bone and through the implant passage. After the drill 2100 is pulled through the bone, the K-wire 2110 can remain in the implant channel to maintain the reduction of the fracture and provide a guide for embedding a cannulated implant (screw, nail, or other) over the K-wire 2110. As shown in FIG. 21B, to improve the strength of the connection between the blind hole 2102 of the drill 2100 and the K-wire 2110, a needle driver 2120 or any other suitable tool can crimp the drill 2100 with the blind hole 2102 and the K-wire 2110 together before pulling the drill 2100 through the bone.

[0161] As shown in FIG. 22A, instead of a blind hole, the drill 2200 can include a female recess 2202 at its rear end 2204. The implant 2230 (screw, nail, or other) can have a male portion 2232 at its front end that nests into the female recess 2202. The implant 2230 does not have to be cannulated. The outer diameter of the drill 2200 can be substantially the same as the minor or root diameter of the implant 2230. As the drill 2200 is pulled through the implant channel on the far side of the bone, the implant 2230 can be pushed along with the drill 2200, for example, using the driver 600 or any other driver, since the male portion 2232 remains nested within the female recess 2202. After the drill 2100 is pulled through the bone, the implant 2230 can remain in the implant channel to maintain the reduction of the fracture and provide fixation of the fractured bone. 22B, the female recess 2202 can have female threads and the mating male portion 2232 can include corresponding male threads to improve the bond strength between the implant 2230 and the drill 2200 when the implant 2230 is inserted into the bone or bone fragment along with the drill 2200. After implantation of the implant 2230, the drill 2200 can be unscrewed and removed from the implant 2230.

[0162] As shown in FIG. 22C, rather than using a hex / hex driver 600 to drive the implant 2230 as shown in FIGS. 22A-22B, the head of the implant 2230 can alternatively be manufactured with a breakaway or snap-on connection 2234 that can be driven by a wire driver 601. The snap-off feature 2234 can be separated from the wire driver 601 with a certain torque or by bending the wire driver 601 back and forth. The wire driver 601 is used to break the implant 2230 after the drill 2200 is used to insert the implant 2230 into the desired location in the bone or bone fragment. It can be separated from 2230.

[0163] 23, when the drill or guidewire 2200 of FIGS. 22A-22B is used to deliver the implant 2300, the hex driver 2300 can optionally include an AO (bonding for bone attachment) feature 2334 and / or a small diameter wire driver portion at its rear end (opposite the hex or hex driver interface end 2332). The AO feature 2334 can allow for powered insertion using a wire driver 2336 or a separate power source with an AO quick connect feature. Alternatively, the driver 2300 can be used by hand without power.

[0164] As shown in FIG. 24, instead of using a stepped guidewire, a solid guidewire 2410 having a larger outer diameter (e.g., about 1.0 mm) than a conventional K-wire can be used. One way to use a slightly larger guidewire, which requires a larger cannulation diameter of the implant, is to increase the outer minor diameter (root diameter) of the implant to maintain the desired implant strength. However, if one wishes to keep the overall outer profile of the implant the same (i.e., the same outer diameter), the implant's thread depth must be reduced. To address the issue of reduced thread depth, as shown in FIG. 24, the implant 2400 can remove the threads along the middle section 2404 of the shaft 2402 (e.g., for about 80% of the length of the shaft). The outer diameter of the unthreaded middle section 2402 can be the same as the major diameter of the threaded portion of the shaft of the implant. The implant 2400 can act as a strong tube or strut while having threads 2406 at the front and rear ends to provide bone engagement. Although the implant 2400 can have a thinner wall thickness, the implant 2400 can have similar strength to the implant 100 because the amount of material in the unthreaded middle portion 2404 is greater than if the middle portion were threaded.

[0165] As shown in FIGS. 25A and 25B, a guidewire 2510 having a larger outer diameter than a conventional K-wire can be connected (e.g., rigidly connected) to a front end 2522 of an implant 2520. The outer diameter of the guidewire 2510 can be substantially the same as the small diameter of the implant 2520. The connection between the guidewire 2510 and the implant 2520 can allow the guidewire 2510 and the implant 2520 to move axially as a single component. The implant 2520 can be any of the examples of implants or screws disclosed herein, or any other implant configured to be inserted into a bone and / or bone fragment. The guidewire 2510 cannot be cannulated. The front end 2512 of the guidewire 2510 can include a sharp tip. In use, the front end 2512 of the guidewire 2510 can facilitate reaming of a bone tunnel through a bone or bone fragment with the implant 2520 connected to the guidewire 2510. Once the implant 2520 is inserted in the desired location, for example, by confirmation using radiography, the guidewire 2510 can be broken off at the leading end 2522 of the implant 2520. The interface between the leading end 2522 of the implant 2520 and the guidewire 2510 can include a thinned portion to allow for easy separation of the guidewire 2520 at the thinned portion. Thus, the combination of the guidewire 2510 and implant 2520 can eliminate the need for a pre-drilling step and a separate reamer (or drill) to insert the implant 2520 into the bone or bone fragment.

[0166] As shown in FIG. 25B, in addition to the anterior guidewire 2510, a posterior guidewire 2530 can be connected (e.g., rigidly connected) to the rear end 2524 of the implant 2520. The connection between the posterior guidewire 2530 and the implant 2520 can allow an axial force applied to the posterior guidewire 2530 to be transmitted axially along the implant 2520 and the anterior guidewire 2510. The guidewire 2530 can have a larger outer diameter than a conventional K-wire, for example, which has an outer diameter substantially the same as the small diameter of the implant 2520. The posterior guidewire 2530 can function as a driver during insertion of the implant 2520 and the anterior guidewire 2510 into the bone or bone fragment. Once the implant 2520 is inserted into the desired position, the guidewire 2530 can be broken at the rear end 2524 of the implant 2520. The interface between the rear end 2524 of the implant 2520 and the rear guidewire 2530 may include a thinned section to allow the rear guidewire 2530 to be easily separated at the thinned section. The addition of the rear guidewire 2530 to the implant 2520 and anterior guidewire 2510 combination may further eliminate the need for a separate driver. The implant 2520 and anterior guidewire 2510 combination, and / or the implant 2520, anterior guidewire 2510, and rear guidewire 2530 combination may be made available in different sizes. The different sizes may correspond to different outer diameters of the implant 2520. term

[0167] Although the present disclosure has been described in connection with certain embodiments and examples, those skilled in the art will recognize that the present disclosure extends beyond the specifically disclosed embodiments to other alternative embodiments and / or uses and their obvious modifications and equivalents. Moreover, while several variations of the embodiments of the present disclosure have been shown and described in detail, other modifications within the scope of the present disclosure will be readily apparent to those skilled in the art. Also, various combinations or subcombinations of specific features and aspects of the embodiments may be made, and these combinations are still considered to be within the scope of the present disclosure. For example, features described above in connection with one embodiment may be used in different embodiments described herein, and the combinations will still be within the scope of the present disclosure. It should be understood that various features and aspects of the disclosed embodiments may be combined with or substituted for each other to form various forms of the embodiments of the present disclosure. Therefore, it is not intended that the scope of the disclosure herein should be limited by the specific embodiments described above. Thus, unless otherwise specified or clearly contradictory, each embodiment of the present invention may include, in addition to its essential features described herein, one or more features described herein from each of the other embodiments of the present invention disclosed herein.

[0168] It should be understood that features, materials, properties, or groups described in connection with a particular aspect, embodiment, or example are applicable to any other aspect, embodiment, or example described in this section or elsewhere in this specification, unless incompatible therewith. All of the features disclosed in this specification (including the accompanying claims, abstract, and drawings), and / or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations in which at least some of such features and / or steps are mutually exclusive. Protection is not limited to the details of any of the foregoing embodiments. Protection extends to any novel, or any novel combination of features disclosed in this specification (including the accompanying claims, abstract, and drawings), or any novel, or any novel combination of steps of any method or process so disclosed.

[0169] Moreover, certain features described in this disclosure in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable subcombination. Furthermore, although features may be described above as acting in a particular combination, one or more features from a claimed combination can, in some cases, be deleted from the combination, and the combination can be claimed as a subcombination or a variation of the subcombination.

[0170] Furthermore, although operations may be shown in the figures or described herein in a particular order, such operations need not be performed in the particular order shown, or in sequential order, or all operations need not be performed to achieve desirable results. Other operations not shown or described may be incorporated into the exemplary methods and processes. For example, one or more additional operations may be performed before, after, simultaneously with, or between any of the described operations. Furthermore, operations may be rearranged or reordered in other implementations. As will be appreciated by those skilled in the art, in some embodiments, the actual steps performed in the illustrated and / or disclosed processes may differ from those shown in the figures. Depending on the embodiment, certain of the steps described above may be omitted and other steps may be added. Furthermore, the features and attributes of certain embodiments disclosed above may be combined in different ways to form additional embodiments, all of which are within the scope of the present disclosure. Also, it should be understood that the separation of various system components in the above implementations should not be understood to require such separation in all implementations, and that the components and systems described may generally be integrated together in a single product or packaged in multiple products.

[0171] For purposes of this disclosure, certain aspects, advantages, and novel features have been described herein. Not necessarily all such advantages may be achieved in accordance with any particular embodiment. Thus, for example, as will be appreciated by those skilled in the art, the present disclosure may be embodied or implemented to achieve one advantage or group of advantages as taught herein without necessarily achieving other advantages as may be taught or suggested herein.

[0172] Conditional language such as "can," "could," "might," or "may," unless otherwise specified or understood otherwise within the context in which it is used, is generally intended to convey that certain embodiments include certain features, elements, and / or steps, but other embodiments do not. Thus, such conditional language does not generally imply that the features, elements, and / or steps are in any way required by one or more embodiments, or that one or more embodiments necessarily include logic for determining whether those features, elements, and / or steps should be included in or performed in any particular embodiment, with or without user input or prompting.

[0173] Conjunctions such as the phrase "at least one of X, Y, and Z," unless otherwise noted, are otherwise understood in the context in which they are generally used to convey that an item, term, etc. can be either X, Y, or Z. Thus, such conjunctives are generally not intended to imply that a particular embodiment requires the presence of at least one of X, at least one of Y, and at least one of Z.

[0174] As used herein, language of degree, such as "approximately," "about," "generally," and "substantially," refers to a value, amount, or characteristic that is close to a stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms "approximately," "about," "generally," and "substantially" can refer to an amount that is within less than 10%, within less than 5%, within less than 1%, within less than 0.1%, and within less than 0.01% of the stated amount.

[0175] The scope of the present disclosure is not intended to be limited by the specific disclosure of preferred embodiments in this section or elsewhere herein, but may be defined by the claims, as presented in this section or elsewhere herein or as presented in the future. The claim language should be interpreted broadly based on the language used in the claims, and not limited to the examples described herein or during prosecution of the application, which examples should be interpreted as non-exclusive.

Claims

1. an implant kit comprising at least one elongate implant, the at least one elongate implant being cannulated and having an implant shaft outer diameter, a root or minor diameter, and an implant cannulation diameter; an instrument kit comprising: a guidewire having at least two diameters and configured to deliver the at least one implant into a fractured bone by intramedullary fixation, the guidewire comprising a first posterior portion having a first diameter and a second anterior portion having a second diameter larger than the first diameter, the second diameter being substantially the same as the outer diameter of the implant or the root or minor diameter of the implant, and the implant cannulation diameter configured to receive the first posterior portion of the guidewire; 10. A system for intramedullary fractures comprising:

2. 10. The system of claim 1, further comprising a sterile sealed package, wherein the at least one elongate implant is contained within the sterile sealed package.

3. The system of claim 1 or 2, wherein the at least one elongate implant is threaded.

4. The system of any one of claims 1 to 3, wherein the at least one elongate implant comprises a driver interface at an end of the implant.

5. The system of claim 4 , wherein the drive head interface comprises a hexagonal interface.

6. The system of any one of claims 1 to 5, wherein the at least one elongate implant has a length of between 10 mm and 50 mm.

7. The system of claim 6, wherein the at least one elongate implant has a length of between 30 mm and 50 mm.

8. The system of any one of claims 1 to 7, wherein the at least one elongate implant has an outer shaft diameter of less than 2.5 mm.

9. 10. The system of claim 8, wherein the at least one elongate implant has an outer shaft diameter of less than 2.2 mm.

10. The system of any one of claims 1 to 9, wherein the at least one elongated implant is configured for fixation of a phalangeal fracture.

11. 11. The system of claim 1, wherein the instrument kit further comprises one or more insertion tools, the one or more insertion tools comprising a larger diameter portion configured to prepare a passage in the fractured bone and a smaller diameter portion configured to guide the first and / or second elongated implants through the passage such that ends of the first and second elongated implants do not protrude into tissue surrounding the bone.

12. The system of any one of claims 1 to 11, wherein the instrument kit further comprises a depth gauge.

13. The system of any one of claims 1 to 12, wherein the instrument kit comprises a sterile, sealed package.

14. 1. A surgical system for delivering an elongated orthopedic implant to a bone for fixation of a fracture, the elongated orthopedic implant comprising an at least partially threaded shaft; The surgical system comprises:

1. A surgical system comprising: an instrument kit including a stepped guidewire having at least two diameters and configured to guide the delivery of the elongated orthopedic implant into bone, the stepped guidewire comprising a first posterior portion having a first diameter and a second anterior portion having a second diameter larger than the first diameter, the second diameter being substantially the same as a minor diameter of a shaft of the implant, the first diameter of the first posterior portion being configured to slidably engage a cannulated portion of the implant.

15. The surgical system of claim 14 , wherein the instrument kit further comprises a driver configured to engage the implant to drive the implant into bone.

16. The surgical system of claim 14 or 15, wherein the instrument kit further comprises a depth gauge.

17. The surgical system of any one of claims 14 to 16, further comprising a sterile sealed package, the instrument kit being contained within the sterile sealed package.

18. The surgical system of any one of claims 14 to 17, wherein the instrument kit is configured for single use.

19. The surgical system according to any one of claims 14 to 17, wherein the instrument kit can be reused by sterilizing it after use.

20. The surgical system of any one of claims 14 to 19, wherein the free end of the second portion of the guidewire comprises a sharp tip.

21. The surgical system of any one of claims 14 to 20, wherein the first substantially uniform outer diameter is between 0.7 mm and 0.9 mm.

22. The surgical system of any one of claims 14 to 21, wherein the second substantially uniform outer diameter is between 1.5 mm and 2.0 mm.

23. The surgical system of any one of claims 14 to 22, wherein the first part and the second part are detachably connected.

24. The surgical system of claim 23, wherein the second portion comprises a cannulation section configured to receive the first portion.

25. The surgical system of claim 24, wherein the cannulation section extends along the entire length of the second portion.

26. The surgical system of claim 24, wherein the cannulation section extends along a portion of the length of the second portion.

27. The surgical system of claim 23, wherein one of the first and second portions includes a hook and the other of the first and second portions includes a loop.

28. The surgical system of any one of claims 14 to 27, further comprising a sterile sealed implant kit, the implant kit comprising one or more elongated orthopedic implants.

29. 30. The surgical system of claim 28, wherein the sterile sealed implant kit is packaged separately from the instrument kit.

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