Bone Fixation Techniques and Implants
The described surgical technique improves implant alignment and fixation in small bones by using wires and an inserter to guide the placement of staples or plates, addressing the challenges of aligning and securing orthopedic implants in bones with misalignments like hallux valgus.
Patent Information
- Application Number
- JP2025515533
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2023-08-11
- Filing Date
- 2023-09-14
- Publication Date
- 2025-09-11
AI Technical Summary
Clinicians face challenges in accurately aligning and securing orthopedic implants, particularly in small anatomical structures like the bones of the foot, during surgical procedures to correct misalignments such as hallux valgus, due to difficulties in aligning the implant with the space between bones and drilling holes in the bone sections.
A surgical technique involving the use of wires inserted into bones to guide an inserter for precise placement of implants like staples or plates, with optional use of a guide to align the space and drill holes, ensuring accurate positioning and fixation of bones.
Enhances the accuracy and stability of implant fixation, reducing the time required for positioning and securing bones, especially in small bones of the foot, by using wires and an inserter to guide the implant placement.
Smart Images

Figure 2025530355000001_ABST
Abstract
Description
[Technical Field]
[0001] Related Stories This disclosure claims priority to U.S. Provisional Patent Application No. 63 / 406,422, filed September 14, 2022, U.S. Provisional Patent Application No. 63 / 444,225, filed February 8, 2023, and U.S. Provisional Patent Application No. 63 / 519,039, filed August 11, 2023. The entire contents of each of these U.S. provisional patent applications are incorporated herein by reference.
[0002] The present disclosure relates generally to devices, systems, and techniques for fixating bones using one or more implants, including devices, systems, and techniques for fixating repositioned bones of the foot using one or more implants, such as bone staples. [Background technology]
[0003] Bones in the human body, such as those of the foot, can become misaligned anatomically. For example, one common type of bone deformity is hallux valgus, a progressive foot deformity that affects the first metatarsophalangeal joint and often results in significant functional disability and foot pain. The metatarsophalangeal joint deviates outward, resulting in the first metatarsal bone abducting while the phalanges adduct. This often leads to soft tissue and bony protrusions on the medial side of the foot, known as hallux valgus.
[0004] Surgical intervention may be utilized to correct hallux valgus deformities. There are a variety of different surgical procedures for correcting hallux valgus deformities, which may involve removing abnormal bony enlargements of the first metatarsal and / or realigning the first metatarsal relative to the adjacent metatarsals. In some procedures, implants can be used to fixate the position of the metatarsals after realignment. Implants can be applied across the tarsometatarsal joint between the metatarsal and the opposing cuneiform. Such implants can hold the metatarsals in their realigned position while bone grows to form a fused connection between the metatarsal and the opposing cuneiform. Summary of the Invention
[0005] In general, the present disclosure relates to orthopedic implants, as well as systems and surgical techniques for applying implants to two opposing bones separated by a space between the bones. This space may be a joint, a bone resection site, or a fracture that is healing. In some embodiments, one or more implants may be used to secure the corrected position of the bones after a realignment procedure. Certain implant features and techniques disclosed herein may be useful to help promote more efficient and effective bone fixation and resulting fusion. By way of example, features related to implants, implant systems, and implant techniques are disclosed herein that may facilitate increasing the accuracy and / or stability of the fixation of the implant to one or more target bones, while also facilitating a reduction in the time it takes to position and fixate the implant.
[0006] Orthopedic implants can be applied during surgical procedures to bones on opposite sides of a space separating bones, such as a joint separating different bones, or to a fracture or osteotomy separating a single bone into different parts. The implant can fix the position of the bones together for healing, during which bone growth closes the space between the bones and fuses the bones. Exemplary implants that can be used during orthopedic procedures include bone plates that are secured to the underlying bone using two or more screws and / or bone staples with at least two legs that are inserted into the underlying bone.
[0007] In practice, it can be difficult for clinicians to align an implant with a target anatomical structure to place the implant in a desired location. This is especially true when dealing with small bony anatomical structures, such as the small bones of the foot. For example, during a surgical procedure, a physician may seek to align an implant with the space separating bones. The clinician may place a first portion of the implant in and / or on one bone and a second portion of the implant in and / or on a second bone, such that the implant spans the space between the bones (e.g., optionally, with the length of the implant substantially centered in the space). The physician may drill a hole in the bone to which the implant will be attached, and then attach the implant to the bone through a hole drilled in the bone. It can be difficult for clinicians to align the implant with the space between the bones and to align the implant with the drill hole when drilling holes in the bone sections.
[0008] According to some examples of the present disclosure, a surgical technique for installing an implant is described. This technique can involve inserting a first wire into a first bone and a second wire into a second bone, where the bones are separated from each other by a space. In some specific embodiments, at least one of the bones is a metatarsal bone of the foot. For example, one of the bones can be a metatarsal bone, and the other can be a cuneiform or cuboid bone separated by a tarsometatarsal joint, or a phalange separated by a metatarsophalangeal joint. In yet another example, each bone can be part of a metatarsal bone, which is divided into two parts by an osteotomy, and one part (e.g., the distal part) is realigned relative to the other part (e.g., the proximal part). In either case, at least one wire can be inserted into each bone, providing at least two wires. The wires can be parallel to each other, for example, extending from the dorsal to the plantar side, and can be inserted through an incision or percutaneously through the skin. One wire may be placed on one side of the space between the two bones and another wire may be placed on the other side of the space.
[0009] With the wire positioned on the opposite side of the space, an implant operably connected to the inserter can be guided along the wire to place the implant at a target location along the bone. The implant can be a plate, staple, or other implant configured to be placed in contact with the outer surface of the bone to be fastened together. The inserter can have a wire-receiving opening through which the wire can be placed to be inserted into the bone. Once the inserter is aligned with the wire, it can be guided along the wire until the implant contacts the underlying bone at a location set by the wire and the relative position of the implant with respect to the inserter.
[0010] If the implant is a staple, the implant can be guided along the wire through the inserter until the legs of the staple are positioned in holes drilled in the underlying bone portion. Depending on the configuration of the inserter, the inserter can engage and / or pass over the top surface of the staple without contacting the bottom surface of the staple (e.g., the bottom surface of the staple bridge). In this configuration, the staple can be guided along the wire through the inserter, and the staple is positioned so that the bottom surface contacts the bone before the inserter is removed from the staple. In some configurations, the inserter can be used to power the staple (e.g., apply a force to move the staple legs relative to each other for insertion, and then release the force to bias the legs back into their original position).
[0011] Configuring the inserter and staple so that the staple legs enter the bone and the bottom surface of the bridge contacts the outer surface of the bone before disengaging the inserter from the staple can be useful to help ensure that the staple is fully seated in the bone and establishes good fixation. Alternative inserter configurations that engage the bottom surface of the staple (e.g., by including one or more legs that wrap around the staple) can be used, but such inserter configurations may require the inserter to be removed from the staple to fully insert the staple into the bone. The inserter can be disengaged to remove the portion of the inserter that is wrapped around the staple from between the bottom surface of the staple and the bone. However, after the inserter is disengaged from the staple in such a configuration, the staple legs may bias back toward their natural position, resisting further insertion of the staple into the bone. This can make it more difficult for the clinician to complete staple insertion (e.g., requiring the clinician to drive the staple into the bone with the leg deflected toward its natural position) compared to inserter configurations that allow the staple to be inserted to the full desired depth in the bone and then the inserter to be disengaged.
[0012] If the implant is a bone plate, the implant can be guided along the wire via the inserter until the holes in the plate are positioned at the target location on the underlying bone (e.g., optionally aligned with holes drilled in the underlying bone portion). The physician can insert screws into the holes in the bone plate to secure the bone plate to the underlying bone. The clinician can use one or more locking screws and / or compression screws.
[0013] When a guidewire is used to guide an inserter operably connected to an implant, the wire can be initially placed in the bone freehand without the aid of a guide, or in other instances, the guide can be used by a clinician to guide the introduction of the wire into the bone. The guide can have an opening through which the wire can be inserted into the underlying bone. The location of the opening in the guide can correspond to the location of the wire-receiving opening in the inserter (e.g., such that the wire inserted into the bone is spaced and / or aligned with the wire-receiving opening in the inserter before the inserter engages the wire). In this manner, the guide and inserter work in conjunction to place the wire in the bone separated by a space and guide the implant operably connected to the inserter via the wire.
[0014] In some configurations, the guide includes and / or is connectable to a seeker that can be inserted into the space between two bones to be fixed using the implant. To accurately and repeatedly align the implant with a space, such as the tarsometatarsal joint space, a clinician can insert the seeker into the space. The seeker can be a wire or other elongated member that can be inserted at least partially, and in some instances completely, into the space. The guide can include a seeker opening that can engage with a portion of the seeker that protrudes from the space between the bones. Alternatively, the guide can include an integral or integrated seeker (e.g., providing a monolithic guide and seeker assembly) that can be inserted into the space between the two bones. In either case, the seeker can align the guide with the space between the two bones to be fixed. The guide can have one or more wire alignment features (e.g., one or more openings) that can be used to sequentially introduce a wire into a first bone at a specified location away from the seeker and then introduce a wire into a second bone at a specified location away from the seeker. Thus, the guide can set the position of the wire and, correspondingly, the final position of the implant, with respect to the space between the two bones.
[0015] In some configurations, the guide is used solely to align the space between two bones and / or to insert a wire into the two bones to subsequently guide placement of the implant. In other configurations, the guide may additionally or alternatively be used to guide the drilling of one or more implant holes in one or both bones to be fixed using the implant. For example, the guide may include one or more drill openings positionable on a first bone to be fixed and one or more drill openings positionable on a second bone to be fixed. A clinician can insert a bone removal tool through the drill openings to form corresponding cavities in the underlying bone. The cavities can be configured (e.g., sized, shaped, and positioned) to receive fixation members associated with the implant, such as staple legs or screws associated with a bone plate. The location of the cavities formed in the bone can be at a specified location relative to a wire previously or subsequently inserted into the bone and / or in the space between the bones located by a seeker. Thus, when an inserter operably coupled to the implant is subsequently guided along the wire, the fixation features of the implant can be precisely aligned with the cavities formed in the bone.
[0016] In some examples according to the present disclosure, orthopedic implants are described in the form of staples. Staples can be applied to the metatarsal and cuneiform bones across the tarsometatarsal joint, for example, during a metatarsal fixation procedure. As described herein, staples can be applied to different bones or bone portions (e.g., across a joint, fracture, or osteotomy). In one example, staples can be applied to the first metatarsal and medial cuneiform bone across the first tarsometatarsal joint. In another example, staples can be applied to the metatarsal and proximal phalanx across the metatarsophalangeal joint. As a further example, staples can be applied to the proximal and distal portions of the metatarsal across a bone cut or fracture that divides the metatarsal into proximal and distal portions.
[0017] The staples can be configured to transition between a natural, undeformed state and a deformed, inserted state upon application / removal of a load force. Thus, as the staples are inserted into the first and second bones, a load force can be applied to the staples to transition them from the natural, undeformed state to the deformed, inserted state. After the staples are desirably inserted into the first and second bones, the load force can be removed from the staples to transition them from the deformed, inserted state to the compression-induced state. When the staples are positioned across a space (e.g., a tarsometatarsal joint space) between the first and second bones (e.g., a metatarsal) and a second bone (e.g., a cuneiform) and transition to the compression-induced state, the staples can function to apply a compressive force to each of the first and second bones to compress the bones together across the space.
[0018] In one example, a method of securing bones for fusion is described. The method includes inserting a first wire into a first bone and a second wire into a second bone, the first bone being separated from the second bone by a space. The method also includes aligning an inserter operably connected to an implant with the first and second wires by placing at least the first wire in a first wire-receiving opening of the inserter and the second wire in a second wire-receiving opening of the inserter. The method includes advancing the inserter along the first and second wires to place the implant in contact with the first and second bones, such that the implant bridges the space between the first and second bones.
[0019] In another example, a method for fixing bones for fusion is described. The method includes placing a first leg of a staple connected to an inserter into a first implant hole in a first bone and a second leg of a staple connected to the inserter into a second implant hole in a second bone. The first bone is separated from the second bone by a space, and the first leg of the staple is connected to the second leg of the staple by a bridge. According to this example, the inserter includes a first coupling shaft connected to the first leg of the staple, a second coupling shaft connected to the second leg of the staple, and a connector. The first and second coupling shafts are biased toward each other to apply a load force to the implant. The connector couples the first and second coupling shafts and maintains the load force applied to the implant while the connector couples the first and second coupling shafts. The method also includes detaching the connector from the inserter, thereby removing the load force, and moving the first and second coupling shafts away from each other.
[0020] In a further example, a system for fixing bones for fusion is described. The system includes a staple and an inserter. The staple includes a first leg on a first side of the staple, a second leg on a second side of the staple, a bridge connecting the first leg and the second leg, a first handling coupling on the first side of the staple, and a second handling coupling on the second side of the staple. The inserter includes a first coupling shaft configured to couple to the first handling coupling, a second coupling shaft configured to couple to the second handling coupling, and a connector configured to couple the first coupling shaft and the second coupling shaft. The connector includes a first wire-receiving opening configured to receive a first wire and a second wire-receiving opening configured to receive a second wire. When the connector is coupled to the first coupling shaft and the second coupling shaft, the connector is configured to bias the first coupling shaft and the second coupling shaft toward each other to apply a load force to the staple. When the connector is removed from at least one of the first coupling shaft and the second coupling shaft, the staple is configured such that the first leg and the second leg move toward each other.
[0021] The details of one or more examples are set forth in the accompanying drawings and the description below. Other features, objects, and advantages will be apparent from the description and drawings, and from the claims. [Brief explanation of the drawings]
[0022] [Figure 1A-1B] 1A and 1B are front views of the foot showing a normal first metatarsal position and an exemplary rotationally misaligned coronal plane position, respectively.
[0023] [Figure 2A-2B] 2A and 2B are top views of the foot showing the normal position of the first metatarsal and an exemplary misaligned position in the transverse plane, respectively.
[0024] [Figure 3A-3B] 3A and 3B are side views of the foot showing the normal position of the first metatarsal and an exemplary misaligned position in the sagittal plane, respectively.
[0025] [Figure 4] FIG. 1 is a flow diagram of an exemplary surgical technique for placing and securing an implant.
[0026] [Figure 5A] 1 shows an orthopedic implant in the form of a staple;FIG. [Figure 5B] 5A and 5B show an orthopedic implant in the form of a staple.
[0027] [Figure 6] 10 is a perspective view of another exemplary configuration of a staple;
[0028] [Figure 7] 10 is a perspective view of another exemplary configuration of a staple;
[0029] [Figure 8] 10 is a perspective view of another exemplary configuration of a staple;
[0030] [Figure 9A-9B] Figures 9A and 9B show an embodiment of a guide, where Figure 9A is a perspective view of the guide and Figure 9B is a top plan view of the body of the guide shown in Figure 9A.
[0031] [Figures 10A-10B] Figures 10A and 10B show another embodiment of a guide, where Figure 10A is a perspective view of the guide and Figure 10B is a top plan view of the body of the guide shown in Figure 10A.
[0032] [Figure 11A] 1 shows an embodiment of an inserter. [Figure 11B] 1 shows an embodiment of an inserter. [Figure 11C] 1 shows an embodiment of an inserter.
[0033] [Figures 12A-12B] Figures 12A and 12B show another embodiment of the inserter, with Figure 12A showing a side view of the inserter in longitudinal section and Figure 12B showing a bottom view of the inserter's cap.
[0034] [Figures 13A-13B] Figures 13A and 13B show yet another embodiment of an inserter, with Figure 13A showing a perspective view of the inserter and Figure 13B showing a bottom view of the inserter's cap.
[0035] [Figure 14] FIG. 13C is a perspective view of an implant tamp feature that may be included in one or more of the inserter embodiments shown in FIGS. 11A-13B.
[0036] [Figure 15] FIG. 1 is a flow diagram of one example of an exemplary surgical technique for placing implants, such as staples, to secure and fuse bones.
[0037] [Figure 16] FIG. 10 is a side view of an embodiment of a seeker inserted into a space (e.g., a joint space) separating a first bone and a second bone.
[0038] [Figure 17] FIG. 17 is a side view of an embodiment of a guide aligned with a first bone and / or a second bone using the seeker of FIG. 16.
[0039] [Figure 18] 18 is a side view of the guide of FIG. 17 being used to drill a first implant hole in a first bone and a second implant hole in a second bone.
[0040] [Figures 19A-19C] 19A-19C show an embodiment of an inserter aligned with wire(s) in a first bone and / or a second bone: Fig. 19A is an elevational view of the inserter coupled to the top surface of the implant, Fig. 19B is a perspective view of the connector components of the inserter separated, and Fig. 19C is an elevational view of the wires in the first and second bones for aligning the inserter.
[0041] [Figure 20] FIG. 19C is a side view of the assembled inserter of FIGS. 19A and 19B with implants, such as staples, advanced along the wire(s) to place them in contact with the first and second bones.
[0042] [Figure 21] 21 is a side view of the inserter of FIG. 20 with the connector components removed, facilitating the implant to fixate the first and second bones and applying a compressive force to the first and second bones.
[0043] [Figures 22A-22B] Figures 22A and 22B show another embodiment of an orthopedic implant in the form of a staple including a fixation aperture, with Figure 22A being a perspective view of this staple embodiment showing the fixation aperture and Figure 22B being a perspective view of this staple embodiment showing a fixation member disposed in the fixation aperture.
[0044] [Figures 23A-23B] Figures 23A and 23B show an embodiment of an orthopedic implant in the form of a staple including fixation apertures, with Figure 23A being a perspective view of this staple embodiment showing the fixation apertures and Figure 23B being a perspective view of this staple embodiment showing the fixation members disposed in the fixation apertures.
[0045] [Figures 24A-24B]24A and 24B illustrate a further embodiment of an orthopedic implant in the form of a staple including a fixation aperture and a particular exemplary anatomical contour, with Fig. 24A being a side view of this embodiment of a staple showing the exemplary anatomical contour, and Fig. 24B being a side view of such an embodiment of a staple with the exemplary anatomical contour positioned across a space separating a first bone and a second bone (e.g., a joint space).
[0046] [Figures 25A-25B] Figures 25A and 25B show another embodiment of an orthopedic implant in the form of a staple including a fixation aperture and a particular exemplary anatomical contour, with Figure 25A being a side view of this embodiment of a staple showing the exemplary anatomical contour, and Figure 25B being a side view of such an embodiment of a staple with the exemplary anatomical contour positioned across a space separating a first bone and a second bone (e.g., a joint space).
[0047] [Figures 26A-26B] Figures 26A and 26B show an embodiment of a multi-piece inserter coupling shaft, with Figure 26A being an exploded elevation view and Figure 26B being an assembled view of this inserter coupling shaft embodiment.
[0048] [Figure 27A] 10A and 10B show an exploded elevational view of another embodiment of a multi-piece inserter coupling shaft. [Figure 27B] 10A and 10B show another embodiment of a multi-piece inserter coupling shaft, and a close-up elevational view of the distal end of this inserter coupling shaft embodiment. [Figure 27C] 10A and 10B show an elevational view of another embodiment of a multi-piece inserter coupling shaft coupled to an exemplary orthopedic implant. [Figure 27D]1C shows another embodiment of a multi-piece inserter coupling shaft. FIG. 1D is a close-up elevational view of the distal end of this inserter coupling shaft embodiment when coupled to an exemplary orthopedic implant as in FIG.
[0049] [Figure 28A] 10A-10C show another embodiment of an orthopedic implant in the form of a staple; [Figure 28B] 10A-10C show another embodiment of an orthopedic implant in the form of a staple; [Figure 28C] 10A and 10B show another embodiment of an orthopedic implant in the form of a staple; DETAILED DESCRIPTION OF THE INVENTION
[0050] In the following description and drawings, like reference characters are used to denote like elements.
[0051] The present disclosure generally relates to implants for fixating one or more bones, related systems (e.g., kits) for bone fixation, and bone fixation techniques incorporating one or more such implants. In some examples, implants according to the present disclosure can be used to fixate a realigned bone or bones during a surgical procedure, such as a metatarsal realignment and fixation procedure. In exemplary applications, the devices, systems, and techniques can be used during surgical procedures performed on one or more bones, such as bone alignment, bone resection, fixation procedures, fracture repair, and / or other procedures requiring setting one or more bones in a desired position. Such procedures can be performed, for example, on bones of the foot or hand (e.g., adjacent bones separated by a joint or different portions of a single bone), which are relatively small compared to bones in other parts of the human anatomy. In one example, a procedure utilizing the devices and / or techniques of the present disclosure can be performed to correct the alignment between a metatarsal (e.g., the first metatarsal) and a cuneiform bone (e.g., the medial cuneiform), such as correcting hallux valgus. One example of such a procedure is the Lapidus procedure. In another example, devices, systems, and / or techniques may be utilized to change the position of one portion of a bone relative to another portion of the same bone. An example of such a procedure is an osteotomy procedure (e.g., a metatarsal osteotomy procedure), in which a bone is cut into at least two different bones and one portion (e.g., a distal portion) is realigned relative to another portion (e.g., a proximal portion) of the same bone.
[0052] Preparation, fixation, and / or fusion of two opposing bone portions, such as the metatarsal and cuneiform bones, may be performed for a variety of clinical reasons and indications in accordance with the present disclosure. Preparation and fusion of the metatarsal and cuneiform bones at the tarsometatarsal ("TMT") joint may be performed to treat hallux valgus and / or other bone and / or joint conditions.
[0053] Hallux valgus, also known as hallux abducto valgus, is a complex, progressive condition characterized by lateral deviation (alversion, eversion) of the great toe and medial deviation of the first metatarsophalangeal joint. Hallux valgus typically causes a progressive increase in the hallux abduction angle, which is the angle between the long axis of the first metatarsal and the proximal phalanx in the transverse plane. As the hallux abduction angle increases, the plantar aponeurosis and tendons of the intrinsic and extrinsic muscles that cross the first metatarsophalangeal joint from the metatarsus to the hallux tend to shift laterally. As a result, the sesamoid bones may also shift (e.g., shift laterally relative to the first metatarsophalangeal joint), leading to subluxation of the joint between the sesamoid bone and the first metatarsal head. This can increase pressure between the medial sesamoid bone and the crest of the first metatarsal head.
[0054] Although techniques and devices are generally described herein in connection with the first metatarsal and medial cuneiform bones of the foot, these techniques and devices can be used with other adjacent bones (e.g., separated from one another by a joint) and / or adjacent bone portions (e.g., portions of the same bone separated from one another by a fracture or osteotomy). In various examples, the disclosed devices, systems, and / or techniques can be utilized with smaller bones of the foot, such as metatarsals (e.g., the first, second, third, fourth, or fifth metatarsals), cuneiform bones (e.g., medial, middle, lateral), cuboid, phalanges (e.g., proximal, middle, distal), and / or combinations thereof. The bones can be separated from one another by tarsometatarsal ("TMT") joints, metatarsophalangeal ("MTP") joints, or other joints. Accordingly, references herein to the first metatarsal and medial cuneiform bones can be substituted for other bone pairs described herein. Furthermore, if an implant according to the present disclosure is intended for use with a different bone or combination of bones other than the first metatarsal and medial cuneiform, the implant configuration (e.g., size, shape) can be adjusted to accommodate the particular bone or combination of bones being fixed, while following the teachings of the implant, e.g., staple configuration outlined herein.
[0055] To further understand the exemplary devices, systems, and techniques of the present disclosure, we will first describe the anatomy of the foot with reference to Figures 1-3, as well as describe exemplary misalignments that may occur and be corrected and fixed in accordance with the present disclosure. The bony misalignments may be caused by hallux valgus (bunion), natural growth deformities, metatarsal adductor tendons, arthritis, and / or other conditions.
[0056] FIGS. 1A and 1B are front views of a foot 200 showing a normal first metatarsal position and an exemplary rotationally misaligned position in the coronal plane, respectively. FIGS. 2A and 2B are top views of a foot 200 showing a normal first metatarsal position and an exemplary misaligned position in the transverse plane, respectively. FIGS. 3A and 3B are side views of a foot 200 showing a normal first metatarsal position and an exemplary misaligned position in the sagittal plane, respectively. While FIGS. 1B, 2B, and 3B illustrate misalignment in each plane alone, in practice, the metatarsals may be misaligned in any two of three planes, or in all three planes. Thus, it should be understood that the depiction of a single plane of misalignment in each of FIGS. 1B, 2B, and 3B is for illustrative purposes only, and that the metatarsals may be misaligned in multiple planes, which it is desirable to correct. Furthermore, it should be understood that a bone condition treated in accordance with the present disclosure may not exhibit any of the exemplary misalignments described with respect to FIGS. 1B, 2B, and 3B, and the disclosure is not limited in this respect.
[0057] 1A and 2A , a foot 200 is comprised of multiple bones, including a first metatarsal 210, a second metatarsal 212, a third metatarsal 214, a fourth metatarsal 216, and a fifth metatarsal 218. The metatarsals are connected distally to phalanges 220, and more specifically, each is connected to a respective proximal phalanx. The first metatarsal 210 is connected proximally to a medial cuneiform 222, the second metatarsal 212 is connected proximally to a middle cuneiform 224, and the third metatarsal 214 is connected proximally to a lateral cuneiform 226. The fourth and fifth metatarsals 216, 218 are connected proximally to a cuboid 228. The joints 230 between the metatarsals and their respective cuneiform bones (e.g., the first metatarsal 210 and the medial cuneiform 222) are referred to as tarsometatarsal ("TMT") joints. The joints 232 between the metatarsals and their respective proximal phalanges are called metatarsophalangeal joints. The angle 234 between adjacent metatarsals (e.g., the first metatarsal 210 and the second metatarsal 212) is called the intermetatarsal angle (IMA).
[0058] As previously mentioned, FIG. 1A is a front view of a foot 200 illustrating a typical position of the first metatarsal 210. The frontal plane, also known as the coronal plane, is generally considered to be any vertical plane that divides the body into anterior and posterior sections. In the foot 200, the frontal plane is a vertically extending plane, perpendicular to an axis extending from proximal to distal along the length of the foot. FIG. 1A illustrates the first metatarsal 210 in a typical rotational position in the frontal plane. FIG. 1B illustrates the first metatarsal 210 with a rotational deformation in the frontal plane characterized by a rotation angle 236 relative to the ground, as indicated by line 238.
[0059] FIG. 2A is a top view of a foot 200 showing a typical position of the first metatarsal 210 in the transverse plane. The transverse plane, also called the horizontal, axial, or transverse plane, is considered any plane that divides the body into upper and lower parts. In the foot 200, the transverse plane extends horizontally and is perpendicular to an axis that crosses the foot from dorsal to plantar (top to bottom). FIG. 2A shows the first metatarsal 210 with a typical IMA 234 in the transverse plane. FIG. 2B shows the first metatarsal 210 with a rotational deformity in the transverse plane, characterized by a larger IMA caused by the distal end of the first metatarsal 210 rotating medially relative to the second metatarsal 212.
[0060] FIG. 3A is a lateral view of a foot 200 showing a typical position of the first metatarsal 210 in the sagittal plane. The sagittal plane is a plane parallel to the sagittal suture that divides the body into right and left halves. In the foot 200, the sagittal plane is a vertically extending plane, perpendicular to an axis extending from proximal to distal along the length of the foot. FIG. 3A shows the first metatarsal 210 in a typical rotational position in the sagittal plane. FIG. 3B shows the first metatarsal 210 with a rotational deformation in the sagittal plane characterized by a rotation angle 240 relative to the ground, as indicated by line 238.
[0061] The surgical techniques and instruments disclosed herein may be useful during procedures to correct misalignment of one or more bones, such as the metatarsal and opposing cuneiform bones, and / or during procedures to promote fusion of the metatarsal and cuneiform bones across the TMT joint. In some applications, the realignment procedure involves surgical access to the TMT joint (e.g., from the medial and / or dorsal aspects of the foot). A clinician can insert bone preparation instruments through the incisions to prepare the end surfaces of one or both bones.
[0062] Before or after preparing one or both ends of the first metatarsal 210 and the medial cuneiform 222, the clinician can realign the metatarsals relative to the cuneiforms. The clinician can laterally rotate the distal end of the first metatarsal 210 toward the second metatarsal 212 to close the intermetatarsal angle between the first and second metatarsals. Additionally or alternatively, the clinician can rotate the first metatarsal 210 in the frontal plane to correct frontal rotation of the metatarsal and / or translate the first metatarsal 210 in the sagittal plane to correct the sagittal position of the metatarsal. Realignment of the first metatarsal 210 can be performed by the clinician freehand or with the aid of a bone positioning device that facilitates the realignment. After achieving the desired realignment in one or more planes, the clinician can apply one or more implants (e.g., one or more staples, plates, pins, screws, rods) to fix the displaced position of the first metatarsal 210. While the present disclosure provides an exemplary embodiment of a staple as a type of implant that can be used to fix one or more bones for fusion, other embodiments within the scope of the present disclosure can use the teachings outlined herein applied to other types of implants, such as plates, for fixating one or more bones for fusion.
[0063] FIG. 4 is a flow diagram of an exemplary method 400 that may include, among other steps, positioning and securing an implant to stabilize the bones for fusion. As described below, in one example, method 400 can be used to prepare, realign, and stabilize two bones across a tarsometatarsal joint. One or more portions of method 400 related to positioning and securing an implant to stabilize the bones for fusion (step 450) are further described with reference to FIGS. 5-21 . Further details regarding exemplary surgical techniques, including exemplary instruments that may be used during the techniques, can be found in U.S. Patent No. 9,622,805, entitled “BONE POSITIONING AND PREPARING GUIDE SYSTEMS AND METHODS,” issued April 18, 2017, and U.S. Patent Application Publication No. 2020 / 0015856, entitled “COMPRESSOR-DISTRACTOR FOR ANGULARLY REALIGNING BONE PORTIONS,” issued January 16, 2020, the entire contents of each of which are incorporated herein by reference.
[0064] In step 410, the method 400 includes making an incision. The incision can be made through the skin, such as on the dorsal side of the foot, the medial side of the foot, or the dorsal-medial side of the foot. The incision allows surgical access to the TMT joint 230, which separates the first metatarsal 210 from the opposing medial cuneiform 222. To surgically access the joint, the patient may be placed supine on an operating room table and administered general or monitored anesthesia. Hemostasis may be achieved by applying a thigh tourniquet or a mid-calf tourniquet. In some instances, imaging of the foot can be used to assist the clinician in identifying the location of the TMT joint 230, which can then be the center of the incision for the skin.
[0065] In step 420, the method 400 includes preparing the first metatarsal 210 and / or the medial cuneiform 222. With the TMT joint 230 exposed through the incision, the end surface (e.g., the proximal end surface) of the first metatarsal 210 and / or the end surface (e.g., the distal end surface) of the medial cuneiform 222 can be prepared. Note that one or both of the metatarsal and cuneiform end surfaces can be prepared before and / or after the metatarsal is translated relative to the cuneiform in one or more planes. Thus, unless otherwise specified, the order of bone preparation and / or translation is not limited.
[0066] Generally, a clinician can prepare the ends of each bone that forms the TMT joint 230 to promote fusion of the bone ends across the TMT joint after realignment. Bone preparation can include using a tissue removal instrument to apply force to the bone end surface to create a bleeding bone surface and promote subsequent fusion. Examples of tissue removal instruments that can be used include, but are not limited to, saws, rotary burrs, rongeurs, reamers, osteotomes, curettes, etc. The tissue removal instrument can be applied to the end surface of the bone to be prepared for cartilage and / or bone removal. For example, the tissue removal instrument can be applied to the end surface to remove cartilage (e.g., all cartilage) down to the subchondral bone. Additionally or alternatively, the tissue removal instrument can be applied to cut, fenestrate, fragment, and / or otherwise reshape the bone end surface and / or create a bleeding bone surface to promote fusion. When performing a cutting operation to remove the bone end, the cut can be performed freehand or with the aid of a cutting guide that has a guide surface that can be positioned over the portion of the bone to be cut. When a bone preparation guide is used, a cutting instrument can be inserted against a guide surface of the bone preparation guide (e.g., between a slot defined between two guide surfaces) to guide the cutting instrument for bone removal.
[0067] In step 430, the method 400 includes moving the first metatarsal 210. As described above, the first metatarsal 210 can be moved before and / or after preparing the first metatarsal 210 and / or the medial cuneiform 222. Moving the first metatarsal 210 in step 430 can include moving the first metatarsal 210 in at least one plane. For example, the first metatarsal 210 can be moved at least in the transverse plane between the first metatarsal 210 and the adjacent second metatarsal 212 and / or in the frontal plane to close the IMA 234 (e.g., to reposition the sesamoid bones substantially centrally below the metatarsal). In some examples, the first metatarsal 210 can be moved in multiple planes, such as the transverse plane, the frontal plane, and / or the sagittal plane (e.g., each of the transverse, frontal, and sagittal planes). The clinician may or may not use a bone positioning device to facilitate movement of the bone portions. Once the position of the first metatarsal 210 is shifted, the first metatarsal 210 may be realigned relative to one of the other adjacent bones.
[0068] In step 440, method 400 may include compressing one or more bones. In some embodiments, step 440 may be omitted depending on the realigned position of the first metatarsal 210. If step 440 is included, the prepared end surfaces of the bone portions of the first metatarsal 210 and the medial cuneiform 222 may be compressed together before using the implant to secure the bones. A clinician may compress the end surfaces together using manual pressure and / or a compression tool physically attached to both the first and second bone portions. Thus, discussion of applying an implant to a first and second bone portion with the implant bridging a space between the bone portions refers to the implant bridging a separation (e.g., a joint, osteotomy, fracture) between the two bone portions, but does not require a gap between the bone portions, as the end surfaces of the bone portions may contact each other and be compressed together.
[0069] In step 450, method 400 includes placing an implant (e.g., an embodiment of a staple disclosed herein) over a portion of the first metatarsal 210, over a portion of the medial cuneiform 222, and across the TMT joint 230 separating the first metatarsal 210 and the medial cuneiform 222. For example, as shown in FIG. 21 , placing the implant in step 450 may include placing an embodiment of a staple (e.g., a compression staple). Placing an implant, such as a staple, may include placing at least one leg of the staple over the first metatarsal 210 and at least another leg of the staple over the medial cuneiform 222, with a bridge connecting the legs of the staple extending across the TMT joint 230. Further, in some examples, placing an implant such as a staple can include placing one leg of the staple over the first metatarsal 210 and then contacting the first metatarsal 210 at a first implant hole in the first metatarsal 210, and placing another leg of the staple over the medial cuneiform 222 and then contacting the medial cuneiform 222 at a second implant hole in the medial cuneiform 222.
[0070] 5A-8 show various embodiments of staples as one exemplary type of implant that can be used to secure and fuse bones.
[0071] Figures 5A and 5B illustrate an embodiment of staple 500. Figure 5A is a perspective view of staple 500, and Figure 5B is a side view of a longitudinal cross section of staple 500. As described elsewhere herein, staple 500 can be configured to apply a compressive force across bones and spaces between bones (e.g., joints) for use in bone fixation and promoting fusion.
[0072] The staple 500 can include a staple body 501 with a first leg 502, a second leg 504, and a bridge 506. In the illustrated embodiment, the staple 500 includes the first leg 502 on a first side 503 of the staple 500 and the second leg 504 on a second side 505 of the staple 500. In this example, the first side 503 is opposite the second side 505. The bridge 506 can connect the first leg 502 and the second leg 504.
[0073] The legs 502, 504 of the staple 500 can be configured for placement within a bone, such as one or more relatively small bones of the foot. For example, the length 512 of each leg 502, 504 can be within a range of 6 mm to 30 mm, such as 8 mm to 25 mm or 10 mm to 20 mm, thereby providing a length sufficient for secure anchoring within a foot bone, such as a metatarsal (e.g., first metatarsal) and / or cuneiform (e.g., medial cuneiform). The width 514 of each leg can be within a range of 1 mm to 4 mm, such as 1.5 mm to 3.5 mm or 2 mm to 3 mm, also providing a length sufficient for secure anchoring within a foot bone. The bridge length 516 of the bridge 506 can be within a range of 6 mm to 30 mm, such as 8 mm to 25 mm, or 12 mm to 20 mm, which may be sufficient to allow the bridge to be placed across a space (e.g., a joint) between the bones of the foot while maintaining the legs 502, 504 with such bones separated by the space. Staples according to the present invention can be configured with dimensions other than the examples given above, and the invention is not limited in this respect.
[0074] As shown in FIG. 5B , the bridge length 516 can be measured from the central longitudinal axis of one leg closest to one side of the bridge 506 to the central longitudinal axis of another leg closest to the opposite side of the bridge 506. The bridge 506 can also define a bridge width 570. In some examples, the bridge width 570 of the staple 500 is constant across the entire width of the staple. In other examples, the bridge width 570 of the staple 500 varies depending on the width of the staple. For example, the bridge width 570 can be substantially constant across a central region along the bridge length 516, and the bridge width 570 can increase as one moves along the bridge length 516 from the central region toward each of the first leg 502 and the second leg 504 (e.g., such that the largest bridge width 570 is located at or adjacent the first leg 502 and the second leg 504). As one such specific example, the bridge width 570 may define a generally hourglass-shaped profile, with a narrow center of the hourglass shape in a central region along the bridge length 516 and wider ends of the hourglass shape at opposite ends of the bridge length 516.
[0075] The first leg 502 can include a first set of teeth 518 around a perimeter 522 of the first leg 502, and the second leg 504 can include a second set of teeth 520 around a perimeter 524 of the second leg 504. The teeth 518, 520 extend outwardly from the respective legs 502, 504 and can be configured to provide an anchoring mechanism for maintaining the respective legs 502, 504 within the respective bone in which they are located. As shown here, the first set of teeth 518 can extend partially around the perimeter 522 of the first leg 502, and the second set of teeth 520 can extend partially around the perimeter 524 of the second leg 504. For example, the first set of teeth 518 can extend around a portion of the circumference 522 of the first leg 502 that faces the bridge 506, and the second set of teeth 520 can extend around a portion of the circumference 525 of the second leg 504 that faces the bridge 506. As one such specific example, the first set of teeth 518 can extend around approximately 180 degrees of the circumference 522 of the first leg 502 closest to the bridge 506, and the second set of teeth 520 can extend around approximately 180 degrees of the circumference 524 of the second leg 504 closest to the bridge 506.
[0076] The staple 500 can further include a first handling coupling 508 and a second handling coupling 510 defined by the staple body 501. In the illustrated embodiment, the staple 500 includes the first handling coupling 508 on a first side 503 of the staple 500 and the second handling coupling 510 on a second side 505 of the staple 500. The first handling coupling 508 can include a first handling coupling receptacle 509 that extends from a top surface 526 of the staple body 501 of the staple 500 toward (e.g., to) a bottom surface 528 of the staple body 501 of the staple 500. As one such specific example, the first handling coupling receptacle 509 can extend downwardly from the top surface 526 down some, but less than the entire, length 512 of the first leg 502. The second handling coupling 510 can include a second handling coupling receptacle 511 that extends from the top surface 526 of the staple body 501 of the staple 500 toward (e.g., to) the bottom surface 528 of the staple body 501 of the staple 500. As one such specific example, the second handling coupling receptacle 511 can extend downwardly from the top surface 526 a portion of, but less than the entire length 512 of the second leg 504. Thus, the first handling coupling 508 and first handling coupling receptacle 509, as well as the second handling coupling 510 and second handling coupling receptacle 511, may be accessible from the top surface 526 of the staple 500, which may be useful in facilitating the placement of the bottom surface 528 of the staple 500 generally flush against one or more bones (e.g., each of two bones separated by a gap such as a joint).
[0077] The first handling coupling receptacle 509 of the first handling coupling 508 can be configured to couple to a first coupling shaft of the inserter, such as at a location between the top surface 526 and the bottom surface of the handling coupling receptacle. The second handling coupling receptacle 511 of the second handling coupling 510 can be configured to couple to a second coupling shaft of the inserter, such as at a location between the top surface 526 and the bottom surface of the handling coupling receptacle. Thus, the first handling coupling receptacle 509 and the second handling coupling receptacle 511 can be configured to operably couple to the first coupling shaft and the second coupling shaft of the inserter, respectively, which are inserted into the first handling coupling receptacle 509 and the second handling coupling receptacle 511 from the top surface 526 and are held within the first handling coupling receptacle 509 and the second handling coupling receptacle 511, respectively, so as not to extend out from the bottom surface of the handling coupling receptacle. The bottom end of each handling coupling receptacle can be closed by a first leg 502 or a second leg 504, respectively, of a solid portion that extends beyond the bottom end of the handling coupling receptacle.
[0078] 5A and 5B, the first handling coupling receptacle 509 and the second handling coupling receptacle 511 include threads extending along the length of the first handling coupling receptacle 509 and the second handling coupling receptacle 511 between the upper and lower surfaces of the handling coupling receptacles. These threads can be configured to connect to complementary threads on the respective first and second coupling shafts of the inserter. However, in other embodiments, the first handling coupling receptacle 509 and the second handling coupling receptacle 511, as well as the first and second coupling shafts of the inserter, can include other means (e.g., bayonet connections) for facilitating operative connection between the respective components.
[0079] Depending on the application for which the staple 500 is used, the staple 500 can be configured to receive one or more solid or liquid substances after the staple is inserted into bone. As one such example, one or both of the first handling coupling receptacle 509 and the second handling coupling receptacle 511 can be configured to receive a filler material therein to substantially occlude the first handling coupling receptacle 509 and / or the second handling coupling receptacle 511 at the upper surface 526. The filler material can be disposed in the first handling coupling receptacle 509 and / or the second handling coupling receptacle 511 after the respective first coupling shaft and / or second coupling shaft is removed from the respective first handling coupling receptacle 509 and / or second handling coupling receptacle 511. For example, a biologically compatible wax or other biologically compatible filler material may be placed within the first handling coupling receptacle 509 and / or the second handling coupling receptacle 511 to block the first handling coupling receptacle 509 and / or the second handling coupling receptacle 511 at or near the top surface 526, thereby facilitating the prevention of bone ingrowth and / or biological material from passing into the first handling coupling receptacle 509 and / or the second handling coupling receptacle 511 after the corresponding inserter coupling shaft is removed.
[0080] As another such example, one or both of the legs 502, 504 can be configured to receive and deliver a substance therethrough. For example, a cannula 560 can be defined within one or both of the legs 502, 504. If included, the cannula 560 can extend along at least a portion (e.g., all of) the length 512 of the legs 502 and / or 504. In one example, the cannula 560 can extend coaxially with a coupling shaft that is received in a handling coupling (e.g., handling coupling 508) of the staple 500. If included, the cannula 560 can have an inlet at a lower end of the respective handling coupling 508, 510, for example, and the cannula 560 can have one or more outlets 561 at locations along the respective legs 502, 504 spaced from the respective handling coupling 508, 510. In the illustrated embodiment, the outlets 561 can be included in each leg 502 and / or 504 between the tines 518, 520. A drug, structural aid, or other biologically compatible substance can be introduced into the cannula 560 at an inlet (e.g., in the respective handling coupling 508, 510), and the substance can be delivered via one or more outlets 561 to one or more bones in which the staple 500 is placed. In other examples, the staple 500 does not include a cannula 560 extending through either of the legs 502, 504. Rather, each leg can be a solid body with the respective handling coupling 508, 510 extending partially but not entirely the length of the solid body, without an additional cannula extending through the leg.
[0081] Additionally or alternatively, staple 500 can be configured with cannulas extending the length of legs 502 and / or 504 for receiving corresponding wires inserted into the bone, thereby facilitating positioning and deployment of the staple in the underlying bone. For example, as described below, instead of using an inserter with wire-receiving openings to guide the positioning of the implant, a wire inserted into the underlying bone can be aligned with cannulas extending through at least two legs of the staple. The cannulas can be aligned with a wire placed in the bone, and the staple is guided along the wire.
[0082] The first leg 502 can define a first leg central longitudinal axis 530 extending through the leg's geometric center, and the leg length 512 can extend along the first leg central longitudinal axis 530. The second leg 504 can define a second leg central longitudinal axis 532 extending through the leg's geometric center, and the leg length 512 can extend therealong. Similarly, the first handling coupling receptacle 509 can extend from the top surface 526 toward (e.g., to) the bottom surface, defining a length along a first handling coupling receptacle central longitudinal axis 534 extending through the handling coupling receptacle's geometric center. The second handling coupling receptacle 511 can extend along a second handling coupling receptacle central longitudinal axis 536 that extends through the geometric center of the handling coupling receptacle, defining a length from the top surface 526 toward (e.g., to) the bottom surface.
[0083] 5B , the central longitudinal axis 530 of the first leg can be offset from the first handling coupling receptacle central longitudinal axis 534, and the central longitudinal axis 532 of the second leg can be offset from the second handling coupling receptacle central longitudinal axis 536. In particular, in this illustrated embodiment of the staple 500, the central longitudinal axis 530 of the first leg can be closer to the bridge 506 than the first handling coupling receptacle central longitudinal axis 534, and the central longitudinal axis 532 of the second leg can be closer to the bridge 506 than the second handling coupling receptacle central longitudinal axis 536. This offset arrangement can facilitate increasing the cross-sectional area (e.g., the amount of material defining the staple body 201 at the intersection) at the intersection of the bridge 506 and the first leg 502 and / or second leg 504. This can facilitate improving the ability of the staple body 501 of the staple 500 to accommodate load forces applied thereto, in a manner that causes the staple 500 to elastically deform as it transitions between its natural, undeformed state and its deformed, inserted state when the load force is applied / removed.
[0084] The staple 500 can have a thickness 550 that can vary in different regions of the staple 500. For example, the staple 500 can have a bridge thickness 550a at the bridge 506, a leg thickness 550b at the first leg 502 and the second leg 504, and a thickness transition region 555 where the bridge 506 transitions to the first leg 502 and the second leg 504, respectively. As shown in the illustrated embodiment, the leg thickness 550b can be thicker than the bridge thickness 550a (e.g., at a central location of the bridge along the bridge length 516), and the thickness transition region 555 can have a thickness transition region thickness 550c that is thicker than the bridge thickness 550a and thinner than the leg thickness 550b. In particular, the thickness transition region 555 can include an increase in the thickness of the staple 500 moving in a direction from the bridge 506 toward the respective legs 502, 504. In one example, the first handling coupling 508 and the first handling coupling receptacle 509 can be positioned in a thickness transition region 555 adjacent the first leg 502, and the second handling coupling 510 and the second handling coupling receptacle 511 can be positioned in a thickness transition region 555 adjacent the second leg 504. Such positioning of the first handling coupling 508 and the first handling coupling receptacle 509, and the second handling coupling 510 and the second handling coupling receptacle 511 in the thickened portion of the staple 500 can facilitate increasing the strength of the staple 500 to undergo a loading force.
[0085] As mentioned above, the staple 500 can be configured to have a natural, undeformed state, examples of which are shown in Figures 5A and 5B. The staple 500 can be configured to transition to a deformed, inserted state when a loading force is applied to the staple 500. The staple 500 can have a biased, compression-induced state in which the first leg 502 and the second leg 504 are angled toward each other, which applies a compressive force that presses together the bones in which the staple 500 is placed and can facilitate applying a compressive force across a separation between bones (e.g., a joint, a bone cut, a fracture) such that the end faces of the opposing bones are pressed together.
[0086] When a loading force is applied to the staple 500, the staple 500 can be configured to transition from an undeformed state, in which the legs of the staple are in a natural or resting position, to a deformed, inserted state in which the first leg 502 and the second leg 504 (e.g., end 537 of the first leg 502 and end 538 of the second leg 504) are spaced further apart (e.g., oriented generally parallel to one another) as compared to the natural state. In particular, the staple 500 can be configured such that when a loading force is applied to the staple 500, the end 537 of the first leg 502 moves in a direction 540 (e.g., away from the bridge 506) and the end 538 of the second leg 504 moves in a direction 542 (e.g., away from the bridge 506) from the undeformed state to the deformed, inserted state. Conversely, when the load force applied to staple 500 is reduced or removed, staple 500 can be configured such that end 537 of first leg 502 is configured to move from the deformed insertion state back to an undeformed state in a direction opposite direction 540 (e.g., toward bridge 506), and end 538 of second leg 504 is configured to move from the deformed insertion state back to an undeformed state in a direction opposite direction 542 (e.g., toward bridge 506).
[0087] In use, the staple 500 can create compression across the end faces of the bone into which the staple is inserted. Compression can occur when the legs of the staple are inserted into the bone (e.g., through a pre-drilled opening in the bone) at a greater spacing and / or angle than the legs' natural, undeformed configuration. The staple legs can be deformed as they are inserted into the bone, and when the force applied to deform the legs is released, the staple legs can resiliently deflect toward their unbiased (natural, or undeformed) shape. However, the spacing and / or angle at which the legs are inserted into the bone can prevent the legs from fully returning to their undeformed state. As a result, the staple can apply a compressive force between the end faces of the bone into which the staple legs are inserted (e.g., a force directed in the direction of the staple legs' convergence). The compressive force can promote healing and fusion of the bone into which the staple is inserted.
[0088] 6 is a perspective view of another embodiment of staple 600. Staple 600 can be similar to or the same as previously described staple 500, except as noted herein. For example, staple 600 can include one or more (e.g., each) of the features (e.g., shape features, dimensional features) disclosed herein for staple 500, except where otherwise noted.
[0089] 6, staple 600 can include a body 601 and a first leg 502 and a second leg 504 of body 601, as well as a third leg 602 and a fourth leg 604 of body 601. In the illustrated embodiment, staple 600 includes first leg 502 and third leg 602 on a first side 603 of bridge 606. The staple also includes second leg 504 and fourth leg 604 on a second side 605 of bridge 606. As shown, first side 603 is opposite second side 605 across bridge 606. Thus, the arrangement of legs 502, 504, 602, 604 of staple 600 can be a four-legged, in-line arrangement.
[0090] In some examples, each leg 502, 504, 602, 604 may have an equal length 512, and in the deflected, compression-induced state of staple 600 shown in FIG. 6 , bridge 606 may arch upward from ends 537, 538 of legs 502, 504, 602, 604 such that ends 537, 538 of legs 602, 604 are at a different height than ends 537, 538 of legs 502, 504. This arrangement may result in legs 602, 604 beginning to insert into one or more bones before legs 502, 504 begin to insert into one or more bones (e.g., because legs 602, 604 may contact one or more bones first, and legs 502, 504 may contact one or more bones later, after legs 602, 604 of staple 600 have begun to insert into one or more bones).
[0091] The bridge 606 can connect the first leg 502 and the third leg 602 to the second leg 504 and the fourth leg 604. The bridge length 516 of the bridge 606 varies depending on the application and, in some examples, is in a range of 10 mm to 75 mm, such as 15 mm to 50 mm, 20 mm to 40 mm, or 25 mm to 40 mm. In some examples, the bridge length 516 of the bridge 606 can be in a range of 28 mm to 34 mm, which may be sufficient to allow the bridge to be placed across a space between bones of the foot (e.g., a joint) while maintaining the legs 502, 602 to one bone and the legs 504, 604 to another bone with the bridge 606 placed across the space between such bones. The bridge length 516 of the bridge 606 can be measured from a central longitudinal axis extending through the geometric center of the outermost leg 602 of the first side 603 to a central longitudinal axis extending through the geometric center of the outermost leg 604 of the second side 605.
[0092] Staple 600 can have first handling coupling 508, second handling coupling 510, first handling coupling receptacle 509, and second handling coupling receptacle 511, and one or more (e.g., all) of the features associated therewith, as disclosed with respect to staple 500. Additionally, staple 600 can have materials and teeth 518, 520 and can be configured to transition between a deflected compression-inducing state and a deformed insertion state, as disclosed with respect to staple 500.
[0093] 7 is a perspective view of yet another embodiment of staple 700. Staple 700 can be similar to or the same as previously described staple 500, except as noted herein. For example, staple 700 can include one or more (e.g., each) of the features disclosed herein with respect to staple 500, except where otherwise noted.
[0094] For example, staple 700 can include a body 701 and a first leg 502 and a second leg 504 of body 701, as well as a third leg 702 and a fourth leg 704 of body 701. In the illustrated embodiment, staple 700 includes a bridge 706, and thus the first leg 502 and the third leg 702, on a first side 703 of staple 700, and a second leg 504 and a fourth leg 704 on a second side 705 of bridge 706, where first side 703 is opposite second side 705. Thus, the arrangement of legs 502, 504, 702, 704 of staple 700 can be a two-by-two leg arrangement, with legs 502, 504 generally aligned across bridge 706 and legs 702, 704 generally aligned across bridge 706. In some examples, each leg 502, 504, 702, 704 can have an equal length 512, and in the deflected compression-induced state of staple 700 shown in FIG. 7, bridge 706 can arch upwardly away from ends 537, 538 of legs 502, 504, 702, 704.
[0095] The bridge 706 can connect the first leg 502 and the third leg 702 to the second leg 504 and the fourth leg 704. The bridge length 516 of the bridge 706 can range from 15 mm to 20 mm, which can be sufficient to allow the bridge to be positioned across a space between the bones of the foot (e.g., a joint) while maintaining the legs 502, 702 on one bone and the legs 504, 704 on another bone separated from one bone by a space. By way of example, the bridge length 516 can be measured from the central longitudinal axis of the leg 502 on the side 703 of the bridge 706 to the central longitudinal axis of the leg 504 on the opposite side 705 of the bridge 706, or from the central longitudinal axis of the leg 702 on the side 703 of the bridge 706 to the central longitudinal axis of the leg 704 on the opposite side 705 of the bridge 706.
[0096] Staple 700 can have first handling coupling 508, second handling coupling 510, first handling coupling receptacle 509, and second handling coupling receptacle 511, and one or more (e.g., all) of the features associated therewith, as disclosed with respect to staple 500. Additionally, staple 700 can have materials and teeth 518, 520 and can be configured to transition between a deflected compression-inducing state and a deformed insertion state, as disclosed with respect to staple 500.
[0097] 8 is a perspective view of a further embodiment of staple 800. Staple 800 can be similar to or the same as previously described staple 500, except as noted herein. For example, staple 800 can include one or more (e.g., each) of the features disclosed herein with respect to staple 500, except where otherwise noted.
[0098] For example, staple 800 can include a body 801 and a first leg 502 and a second leg 504 of body 801, as well as a third leg 702 and a fourth leg 704 of body 801. In the illustrated embodiment, staple 800 includes a bridge 806, and thus a first leg 502 and a third leg 702, on a first side 703 of staple 800, and a second leg 504 and a fourth leg 704 on a second side 705 of bridge 806, where first side 703 is opposite second side 705. Thus, the arrangement of legs 502, 504, 702, 704 of staple 700 can be a two-by-two leg arrangement, with legs 502, 504 generally aligned across bridge 706 and legs 702, 704 generally aligned across bridge 706. In some examples, each leg 502, 504, 702, 704 can have an equal length 512, and in the deflected compression-induced state of staple 700 shown in FIG. 7, bridge 806 can arch upwardly away from ends 537, 538 of legs 502, 504, 702, 704.
[0099] The bridge 806 can connect the first leg 502 and the third leg 702 to the second leg 504 and the fourth leg 704. The bridge length 516 of the bridge 806 can range from 15 mm to 20 mm, which can be sufficient to allow the bridge to be positioned across a space between the bones of the foot (e.g., a joint) while maintaining the legs 502, 702 on one bone and the legs 504, 704 on another bone separated from one bone by a space. By way of example, the bridge length 516 can be measured from the central longitudinal axis of the leg 502 on the side 703 of the bridge 806 to the central longitudinal axis of the leg 504 on the opposite side 705 of the bridge 806, or from the central longitudinal axis of the leg 702 on the side 703 of the bridge 806 to the central longitudinal axis of the leg 704 on the opposite side 705 of the bridge 806.
[0100] Staple 800 can further include a height transition region 850 at bridge 806. Height transition region 850 can define a change in height along the length of bridge 806. For example, the presence of height transition region 850 at bridge 806 can result in side 703 being at a different height than side 705. In the illustrated embodiment of staple 800, side 703 is at a higher height than side 705. The presence of height transition region 850 at bridge 806 can help facilitate stable placement and fixation of staple 800 on bone surfaces of different heights. For example, height transition region 850 can be positioned at an offset height between the metatarsal bone and the opposing cuneiform bone across the tarsometatarsal joint.
[0101] Staple 800 can have first handling coupling 508, second handling coupling 510, first handling coupling receptacle 509, and second handling coupling receptacle 511, and one or more (e.g., all) of the features associated therewith, as disclosed with respect to staple 500. Additionally, staple 700 can have materials and teeth 518, 520 and can be configured to transition between a deflected compression-inducing state and a deformed insertion state, as disclosed with respect to staple 500.
[0102] Staples according to the present disclosure (e.g., staples 500, 600, 700, 800) can be manufactured from a variety of different materials. Staples can be manufactured from biocompatible metals (e.g., titanium, stainless steel, nickel-titanium alloy (nitinol)). In one example, the staples are manufactured from titanium (e.g., the staples are formed from a metal consisting of, or consisting essentially of, titanium). The metal from which the staples are formed can be substantially or completely free of nickel. Titanium can be useful in that it can withstand high-energy forces without breaking, avoiding the issue of hypersensitivity to nickel that may occur in some patients. In this configuration, the entire body of the staple (e.g., bridge, legs) can be formed from titanium. During insertion, the legs of a titanium staple can elastically deform, allowing the legs to return to their original, undeformed position. Other materials, including combinations of different materials, may be used in other configurations of staples according to the present disclosure.
[0103] 9A and 9B show an embodiment of a guide 900. Fig. 9A is a perspective view of the guide 900, and Fig. 9B is a top plan view of the body 901 of the guide 900. The guide 900 can be useful in helping to prepare and facilitate the desired placement of an implant, such as any of the staple embodiments disclosed herein, into and across a target bone for fixation and fusion.
[0104] The guide 900 may include a body 901 and a handle 907. The body 901 may define a body length 903 and a body width 905, the body width 905 being transverse to the body length 903. The handle 907 may be connected to and extend away from the body 901. The handle 907 may be configured to be held in a user's hand, and in the illustrated embodiment, as the handle 907 extends outwardly from the body 901, the handle 907 slopes upwardly, away from the body 901, creating a more ergonomic orientation of the handle 907, which also generally facilitates convenient placement of the body 901 against one or more bones (or tissue overlying such one or more bones).
[0105] The guide 900 can include a first wire opening 902 extending through the body 901 and a second wire opening 904 in the body 901. The first wire opening 902 can be configured to pass a first wire, and the second wire opening 904 can be configured to receive and pass a second wire. The first wire opening 902 and the second wire opening 904 can facilitate facilitating desired placement of wires extending through the openings in relatively small target bones by providing alignment guides that position wires in consistent and repeatable positions and / or spacings. The first wire opening 902 and the second wire opening 904 can be spaced apart along the body length 903 of the body 901 by a distance corresponding to the space between two relatively small bones of the foot (e.g., the TMT joint space separating the medial cuneiform and the first metatarsal).
[0106] As an example, the guide 900 can be configured, at least in part, to be used as a drill guide. In such an example, the guide 900 can further include a first drill guide opening 906 extending through the body 901 and a second drill guide opening 908 extending through the body 901. The first drill guide opening 906 and the second drill guide opening 908 can be configured to receive a drill or other tool capable of forming an implant hole in the underlying bone. Similar to the first wire opening 902 and the second wire opening 904, the first drill guide opening 906 and the second drill guide opening 908 can be spaced apart along the body length 903 of the body 901 by a distance corresponding to the space between two relatively small bones of the foot (e.g., a distance corresponding to the TMT joint space separating the medial cuneiform and the first metatarsal).
[0107] In the illustrated embodiment of guide 900, body 901 includes first and second wire openings 902, 904 generally aligned on a first common axis 910 running parallel to body length 903, and body 901 includes first and second drill guide openings 906, 908 generally aligned on a second common axis 912 running parallel to body length 903, with first common axis 910 offset from second common axis 912 by a distance 914 in a direction parallel to body width 905. In the illustrated embodiment of guide 900, first and second wire openings 902, 904 are positioned closer to each other along body length 903 than first and second drill guides 906, 908. In this illustrated embodiment, first and second drill guide openings 906, 908 are positioned at opposite ends of body length 903.
[0108] The guide 900 can further include a seeker-receiving opening 916 in the body 901. The seeker-receiving opening 916 can be configured to receive a seeker. The seeker-receiving opening 916 can be positioned on the body 901 at a location on the body 901 that generally corresponds to the location of an inter-bone space when the guide 900 is positioned in the target anatomy. As shown here, the seeker-receiving opening 916 can be positioned on the body 901 between the first wire opening 902 and the second wire opening 904 along the body length 903, and between the first drill guide 906 and the second drill guide 908 along the body length 903. Thus, when the body 901 is placed in the target anatomy with the first wire opening 902 and the first drill guide 906 disposed in the body 901 at a location corresponding to the first bone, and when the body 901 is placed in the target anatomy separated from the first bone by a space with the second wire opening 904 and the second drill guide 908 disposed in the body 901 at a location corresponding to the second bone, the seeker receiving opening 916 may be located in the body 901 between these features at a location on the body 901 that generally corresponds to the location of this space between the bones when the guide 900 is placed in the target anatomy. In one example, in addition to or instead of the seeker receiving opening 916, the guide 900 may include a seeker integral with the body 901 at the seeker receiving opening 916, which may extend outward from the body 901 in the direction of the space between the bones when the guide 900 is placed in the target anatomy. In another example, the seeker is separated from the body 901 and inserted into (e.g., through) the seeker-receiving opening 916, as shown in subsequent figures.
[0109] The features described herein as wires can be implemented using K-wires, Steinmann pins, and / or other surgically acceptable wires. Each wire may or may not have a threaded distal end and / or a sharpened distal tip to facilitate insertion into bone. Each wire may have a circular cross-sectional shape or other polygonal (e.g., square, triangular, hexagonal) or arcuate shape.
[0110] 10A and 10B illustrate an embodiment of a guide 1000. FIG. 10A is a perspective view of the guide 1000, and FIG. 10B is a top plan view of the body 1001 of the guide 1000. The guide 1000 may be similar to or the same as the previously described guide 900, except as noted herein. For example, the guide 1000 may include one or more (e.g., each) of the features disclosed herein with respect to the guide 900, except where otherwise noted.
[0111] For example, the guide 1000 can have an offset arrangement of the wire openings 902, 904. The body 1001 has a body length 903 and a body width 905, and the first wire opening 902 and the second wire opening 904 can be disposed opposite each other along the body length 903 and opposite each other along the body width 905. The body 1001 can include a first drill guide opening 906 and a second drill guide opening 908 that are generally aligned on a second common axis 912 that runs parallel to the body length 903, and the body 1001 can include the first wire opening 902 on one side of the second common axis 912 and the second wire opening 904 on another opposite side of the second common axis 912, such that the first wire opening 902 and the second wire opening 904 can be spaced apart from each other in a direction parallel to the body width 905. Although offset in a direction parallel to the body width 905, the first wire opening 902 and the second wire opening 904 can be positioned closer to each other when measured in a direction parallel to the body length 903 than if the first drill guide opening 906 and the second drill guide opening 908 were in a direction parallel to the body length 903. This offset positioning of the first wire opening 902 and the second wire opening 904 may facilitate easier reverse (e.g., mirror image) placement of the guide 1000 in the target anatomy, which may help reduce instances where repositioning of the wire in the bone is required.
[0112] Further guide embodiments may be similar to or the same as guide 900 or guide 1000, except that such additional guide (e.g., drill guide) embodiments may have two or more wire openings in the body. In example embodiments of such additional guides, the body of the guide may include at least four wire openings. For example, two such wire openings may be located on one side of the body (e.g., a first side at or near a first end along the width of the body on one side of the drill guide opening), and two other such wire openings may be located on another, opposite side of the body (e.g., a second side at or near a second, opposite end along the width of the body on the other opposite side of the drill guide opening). When using such additional guide embodiments, a user may select a side of the body (e.g., a side located closest to the medial side of the foot) and insert one or more wires into at least two wire openings on the selected side of the body.
[0113] 11A-11C illustrate an embodiment of an inserter 1100. FIG. 11A illustrates the disassembled components of the inserter 1100, FIG. 11B illustrates the assembled components of the inserter 1100, and FIG. 11C illustrates the inserter 1100 operably connected to a staple 500.
[0114] The inserter 1100 can include a first coupling shaft 1102, a second coupling shaft 1104, and a connector 1106. The first coupling shaft 1102 and the second coupling shaft 1104 can be configured to operably connect to an implant, such as a staple. The illustrated embodiment of the inserter 1100 shows the first coupling shaft 1102 and the second coupling shaft 1104, each configured to operably couple to a staple 500 (or another staple configuration described herein). The connector 1106 can be configured to couple the first coupling shaft 1102 and the second coupling shaft 1104, for example, as shown in the example of FIG. 11B.
[0115] In particular, the first coupling shaft 1102 can be configured to operably couple to the staple 500 at the first handling coupling 508, and the second coupling shaft 1104 can be configured to operably couple to the second handling coupling 510. For example, the first coupling shaft 1102 can have a distal end 1103, and the second coupling shaft 1104 can have a distal end 1105, each of such distal ends 1103, 1105 can include an implant coupling member 1107. The coupling member 1107 at the distal end 1103 of the first coupling shaft 1102 can be configured to operably connect to a complementary coupling member of the first handling coupling 508, and the coupling member 1107 at the distal end 1105 of the second coupling shaft 1104 can be configured to operably connect to a complementary coupling member of the second handling coupling 510. In this manner, the inserter 1100 can include a first coupling shaft 1102 connected to a first side of the implant, e.g., a first side 503 of the staple 500, and a second coupling shaft 1104 connected to a second side of the implant, e.g., a second side 505 of the staple 500.
[0116] As one such specific example, each of the first handling coupling 508 and the second handling coupling 510 may then include threads as a type of complementary coupling member. The coupling member 1107 on the distal end 1103, 1105 of each of the first and second coupling shafts 1102, 1104 may include threads configured to operably couple to complementary threads on each of the first and second handling couplings 508, 510. Thus, in this particular example, operably coupling the inserter 1100 to an implant, such as a staple 500, may include threaded insertion of the first coupling shaft 1102 into the first handling coupling 508 (e.g., from the top surface 526 of the staple 500) and threaded insertion of the second coupling shaft 1104 into the second handling coupling 510 (e.g., from the top surface 526 of the staple 500). Types of mechanical connections other than threads may also be used.
[0117] 11C , each of the first and second coupling shafts 1102, 1104 can be configured to couple to the first and second handling coupling receptacles 509, 511, respectively, at a location between the top surface 526 of the staple 500 and the bottom surface 528 of the staple 500. For example, the first coupling shaft 1102 can be operably coupled to the first handling coupling 508 in a direction from the top surface 526 toward the bottom surface 528, but the first coupling shaft 1102 does not extend beyond the bottom surface 528. Similarly, the second coupling shaft 1104 can be operably coupled to the second handling coupling 510 in a direction from the top surface 526 toward the bottom surface 528, but the second coupling shaft 1104 does not extend beyond the bottom surface 528. As one such example, the coupling member 1107 of the first coupling shaft 1102 can extend into the first handling coupling receptacle 509 such that a distal end of the coupling member 1107 of the first coupling shaft 1102 is received within the staple 500 (e.g., within the first handling coupling receptacle 509). Similarly, the coupling member 1107 of the second coupling shaft 1104 can extend into the second handling coupling receptacle 511 such that a distal end of the coupling member 1107 of the second coupling shaft 1104 is received within the staple 500 (e.g., within the second handling coupling receptacle 511).
[0118] The inserter 1100 can be configured to couple to the staples through the top surfaces 526 of the staples 500. The first handling coupling 508 can pass through the top surfaces 526 of the staples 500 on a first side 503 of the staples 500, and the second handling coupling 510 can pass through the top surfaces 526 of the staples 500 on a second side 505 of the staples 500. The inserter 1100 can be configured to couple to the first handling coupling 508 through the top surfaces 526 of the staples 500 without extending below the bottom surfaces 528 of the staples 500, and the inserter 1100 can be configured to couple to the second handling coupling 510 through the top surfaces 526 of the staples 500 without extending below the bottom surfaces 528 of the staples 500. In one exemplary application in which the staple 500 is placed in a metatarsal, cuneiform bone, and bridges a space between the metatarsal and cuneiform bone (e.g., a joint space such as the TMT joint space), when the inserter 1100 is connected to the first handling coupling 508 and / or the second handling coupling 510 via the upper surface 526 without extending below the bottom surface 528 of the staple 500, the bottom surface 528 of the staple 500 can be configured to directly contact at least one of the metatarsal and cuneiform bone without any inserter 1100 structure between the bottom surface 528 and at least one of the metatarsal and cuneiform bone. This configuration may allow the bottom surface 528 of the staple 500 to be positioned more flush against the metatarsal and / or cuneiform bone when such an inserter is coupled to the staple 500, as compared to a configuration in which inserter structure resides between the bottom surface 528 and the metatarsal and / or cuneiform bone. When the inserter 1100 is coupled to the first and second handling couplings 508, 510 via the top surface 526 of the staple 500 without extending below the bottom surface 528 of the staple 500, the inserter 1100 can be configured to apply a load force to the staple 500 to move the first and second legs 502, 504 away from each other.
[0119] In some additional or alternative examples in which the inserter 1100 is configured to couple to the staple 500 via the top surface 526 of the staple 500, the inserter 1100 can be configured to connect to the first side 503 of the staple 500 via the top surface 526 without extending below the bottom surface 528 and without contacting the outer periphery of the first side 503 of the staple 500, and the inserter 1100 can be configured to connect to the second side 505 of the staple 500 via the top surface 526 without extending below the bottom surface 528 and without contacting the outer periphery of the second side 505 of the staple 500. For example, the inserter 1100 can be configured to connect to the first side 503 of the staple 500 via the top surface 526 without extending below the bottom surface 528 and without contacting the outer periphery of the first side 503 of the staple 500 formed by the side wall 506A (reference letter shown in FIG. 27D ) connecting the top surface 526 of the staple 500 to the bottom surface 528 of the staple 500; similarly, the inserter 1100 can be configured to connect to the second side 505 of the staple 500 via the top surface 526 without extending below the bottom surface 528 and without contacting the outer periphery of the second side 505 of the staple 500 formed by the side wall 506A.
[0120] In some additional or alternative examples where the inserter 1100 is configured to couple to the staple 500 via the upper surface 526 of the staple 500, the inserter 1100 can be configured to connect to the first side 503 of the staple 500 via the upper surface 526 without extending below the lower surface 528, such that when the inserter 1100 is connected to the first handling coupling 508, the lower surface 528 of the staple 500 is configured to directly contact one or more bones without any inserter 1100 structure between the lower surface 528 and such one or more bones. Similarly, the inserter 1100 can be further configured to connect to the second side 505 of the staple 500 via the top surface 526 without extending below the bottom surface 528, such that when the inserter 1100 is connected to the second handling coupling 510, the bottom surface 528 of the staple 500 is configured to directly contact one or more bones without any inserter 1100 structure between the bottom surface 528 and such one or more bones.
[0121] In some additional or alternative examples where the inserter 1100 is configured to couple to the staple 500 via the top surface 526 of the staple 500, the staple 500 and the inserter 1100 can be configured such that when the inserter 1100 is coupled to the first handling coupling 508, the inserter 1100 contacts the first handling coupling 508 and the inserter 1100 is isolated by the first handling coupling 508 from contacting any of the peripheral side walls (e.g., side wall 506A) of the staple 500 that connect the top surface 526 of the staple 500 to the bottom surface 528 of the staple 500. Similarly, the staple 500 and the inserter 1100 can be further configured such that when the inserter 1100 is coupled to the second handling coupling 510, the inserter 1100 contacts the second handling coupling 510 and the inserter 1100 is isolated from any contact with the peripheral side walls (e.g., side wall 506A) of the staple 500 at the second handling coupling 510. As one such specific example, the staple 500 and the inserter 1100 can be configured such that when the inserter 1100 is coupled to the staple 500 with a first handling coupling 508, the inserter 1100 is limited to contacting the staple 500 only at a first handling coupling receptacle 509 defined by the first handling coupling 508, and when the inserter 1100 is coupled to the staple 500 with a second handling coupling 510, the inserter 1100 is limited to contacting the staple 500 only at a second handling coupling receptacle 511 defined by the second handling coupling 510.
[0122] In various embodiments, the inserter 11100 (e.g., the coupling shafts 1102, 1104) can be configured to couple to the staples 500 via the upper surfaces 526 of the staples 500 such that only the staples 500 and no portion of the inserter 1100 (e.g., any portion of the coupling shafts 1102, 1104) define a contact interface with the one or more bones into which the staples 500 are inserted. This coupling configuration of the staples 500 and the inserter 1100 (e.g., the coupling shafts 1102, 1104), such that only the staples contact the one or more bones into which the staples 500 are inserted, can facilitate flush insertion of the staples 500 into the one or more bones because no structure of the inserter 1100 (e.g., structure of the coupling shafts 1102, 1104) is in a position that contacts the one or more bones that would prevent the staples 500 from being inserted flush into the one or more bones. As an example, the inserter 1100 (e.g., coupling shafts 1102, 1104) can be configured to couple to the staples 500 by contacting the staples 500 only at a location above the bottom surface 528 of the staples 500. In the illustrated embodiment of the coupling shafts 1102, 1104, the coupling shafts 1102, 1104 can be configured to contact the staples 500 only at a location above the bottom surface 528 of the staples 500. As shown in this illustrated embodiment in FIGS. 11B and 11C, when the coupling shafts 1102, 1104 are coupled to the staples 500, the implant coupling member 1107 of each coupling shaft 1102, 1104 contacts the staples 500 only at a portion of the staple above the bottom surface 528 of the staples 500. In such an embodiment, when the inserter 1100 is coupled to the staple 500, (i) it contacts the outer peripheral sidewall 506a of the staple 500, and (ii) there can be no structure of the inserter 1100 below the bottom surface 528 of the staple 500.
[0123] In further embodiments, shaft stabilizing arms can be included on the first coupling shaft 1102 and / or the second coupling shaft 1104 to provide additional stability when applying a load force to the implant (e.g., staple 500). If so included, the shaft stabilizing arms can be included on the respective distal ends 1103, 1105 of the respective coupling shafts 1102, 1104 and extend in a direction parallel to the central longitudinal axis of the respective coupling shafts 1102, 1104. When the implant is a staple, the shaft coupling arms can be configured to contact the bridge of the staple (e.g., contact the top and / or sides of the bridge, but not the bottom surface of the bridge) when the coupling members 1107 of the respective shafts 1102, 1104 are in their respective handling couplings of the staple. The inclusion of such shaft stabilizing arms can help provide additional stability when applying a load force to the implant (e.g., staple) and deploying the implant (e.g., staple) in the target anatomical structure.
[0124] In some examples where the inserter 1100 is configured to couple to the staples 500 via the top surface 526 of the staples 500 and includes one or more shaft stabilizing arm(s), the inserter 1100 can be further configured to couple to a first handling coupling 508 via the top surface 526 of the staples 500 without extending down the entire thickness 550 of a peripheral side wall (e.g., side wall 506A) of the staples 500 that connects the top surface 526 of the staples 500 to a bottom surface 528 of the staples 500. Similarly, the inserter 1100 can be further configured to couple to a second handling coupling 510 via the top surface 526 of the staples 500 without extending down the entire thickness 550 of a peripheral side wall (e.g., side wall 506A) of the staples 500 that connects the top surface 526 of the staples 500 to a bottom surface 528 of the staples 500. In an alternative example in which the inserter 1100 is configured to couple to the staple 500 via the top surface 526 of the staple 500, the inserter 1100 may be further configured to (i) couple to the first handling coupling 508 via the top surface 526 of the staple 500 without extending downward more than three-quarters of the peripheral side wall (e.g., side wall 506A) of the staple 500 that connects the top surface 526 of the staple 500 to the bottom surface 528 of the staple 500, and (ii) couple to the second handling coupling 510 via the top surface 526 of the staple 500 without extending downward more than three-quarters of the peripheral side wall (e.g., side wall 506A) of the staple 500 that connects the top surface 526 of the staple 500 to the bottom surface 528 of the staple 500.In another alternative example in which the inserter 1100 is configured to couple to the staple 500 via the top surface 526 of the staple 500, the inserter 1100 may be further configured to (i) couple to the first handling coupling 508 via the top surface 526 of the staple 500 without extending downwardly more than half of the peripheral side wall (e.g., side wall 506A) of the staple 500 that connects the top surface 526 of the staple 500 to the bottom surface 528 of the staple 500, and (ii) couple to the second handling coupling 510 via the top surface 526 of the staple 500 without extending downwardly more than half of the peripheral side wall (e.g., side wall 506A) of the staple 500 that connects the top surface 526 of the staple 500 to the bottom surface 528 of the staple 500. In these noted examples, the thickness 550 of the peripheral sidewall (e.g., sidewall 506A) of the staple 500 connecting the upper surface 526 of the staple 500 and the lower surface 528 of the staple 500 can be at least 0.5 mm. Thus, in examples where the inserter 1100 is configured to couple to the first handling coupling 508 and the second handling coupling 510 without extending down more than three-quarters of the peripheral sidewall (e.g., sidewall 506A) of the staple 500, the inserter can be configured to couple to the peripheral sidewall (e.g., sidewall 506A) of the staple 500 without extending down more than three-quarters of the at least 0.5 mm thickness 550. Also, in examples where the inserter 1100 is configured to couple to the first handling coupling 508 and the second handling coupling 510 without extending downwardly more than half of the peripheral side wall (e.g., side wall 506A) of the staple 500, the inserter can be configured to couple without extending downwardly more than half of the thickness 550 of the peripheral side wall (e.g., side wall 506A) of at least 0.5 mm.
[0125] The inserter 1100 may further include a first wire-receiving opening 1110, a second wire-receiving opening 1112, a first receptacle 1114, and a second receptacle 1116. The first wire-receiving opening 1110 may be configured to receive a first wire, and the second wire-receiving opening 1112 may be configured to receive a second wire. The first receptacle 1114 may be configured to receive and hold a first coupling shaft 1102, e.g., a proximal end 1120 of the first coupling shaft 1102, and the second receptacle 1116 may be configured to receive and hold a second coupling shaft 1104, e.g., a proximal end 1122 of the second coupling shaft 1104. In the illustrated embodiment, the connector 1106 includes a first wire-receiving opening 1110, a second wire-receiving opening 1112, a first receptacle 1114, and a second receptacle 1116, respectively.
[0126] As described above, the connector 1106 can be configured to couple the first coupling shaft 1102 and the second coupling shaft 1104, as shown in the example of FIG. 11B. By way of example, the connector 1106 can be configured to couple the first coupling shaft 1102 and the second coupling shaft 1104 by receiving the first coupling shaft 1102 in a first receptacle 1114 of the connector 1106 and receiving the second coupling shaft 1104 in a second receptacle 1116 of the connector 1106. In this manner, the receptacles 1114, 1116 of the connector 1106 receive and retain the respective coupling shafts 1102, 1104, thereby allowing the connector 1106 to removably couple the coupling shafts 1102, 1104.
[0127] To help facilitate more secure connection of the coupling shafts 1102, 1104 via the connector 1106, the first coupling shaft 1102 may include a first retaining feature 1126 and the second coupling shaft 1104 may include a second retaining feature 1128. For example, the first retaining feature 1126 may be located at or near the proximal end 1120 of the first coupling shaft 1102, and the second retaining feature 1128 may be located at or near the proximal end 1122 of the second coupling shaft 1104. The first retaining feature 126 may be configured to help retain the first coupling shaft 1102 in the first receptacle 1114, and the second retaining feature 1128 may be configured to help retain the second coupling shaft 1104 in the second receptacle 1116. In one such further example, connector 1106 may include a first retention mating feature 1127 in first receptacle 1114 and a second retention mating feature 1129 in second receptacle 1116. First retention mating feature 1127 may be complementary to first retention feature 1126 and configured to receive and retain first retention feature 1126, and second retention mating feature 1129 may be complementary to second retention feature 1128 and configured to receive and retain second retention feature 1128. First retention feature 1126 and first retention mating feature 1127, and second retention feature 1128 and second retention mating feature 1129 may take any of a variety of suitable forms of complementary connector pairs, including, but not limited to, complementary structures that create an interference fit. As one specific example of such a configuration, the first retaining feature 1126 and the first retaining mating feature 1127, and the second retaining feature 1128 and the second retaining mating feature 1129 may be a complementary connector pair that provides a retention force in a direction generally parallel to the longitudinal axis of the coupling shafts 1102, 1104, and that is configured to release this retention force when at least one of the complementary connectors of the pair moves in a direction generally perpendicular to the longitudinal axis of the coupling shafts 1102, 1104 (e.g., when one of the coupling shaft 1102 and the receptacle 1114 moves, and when one of the coupling shaft 1104 and the receptacle 1116 moves).
[0128] As one such specific example, the connector 1106 shown in the illustrated embodiment of the inserter 1100 can include caps 1124. In the illustrated embodiment of the inserter 1100, the caps 1124 can be configured to be disposed over the proximal end 1120 of the first coupling shaft 1102 (e.g., opposite the implant, such as staple 500) and over the proximal end 1122 of the second coupling shaft 1104 (e.g., opposite the implant, such as staple 500). For example, the cap 1124 can be configured to couple the first coupling shaft 1102 and the second coupling shaft 1104 by placing a first receptacle 1114 of the cap 1124 on the proximal end 1120 of the first coupling shaft 1102 and a second receptacle 1116 of the cap 1124 on the proximal end 1122 of the second coupling shaft 1104, and then moving the cap 1124 while so positioned relative to the first coupling shaft 1102 and the second coupling shaft 1104 (e.g., in a direction toward one or more bones) so that the proximal ends 1120, 1122 are received and retained in the respective receptacles 1114, 1116. Similarly, the cap 1124 can be similarly configured to receive and hold first and second wires positioned on one or more bones in the respective first wire-receiving openings 1110 and second wire-receiving openings 1112 when the cap 1124 is moved relative to such wires (e.g., in a direction toward the one or more bones).
[0129] The cap 1124 can further include a surface contour 1130. The surface contour 1130 can be adjusted to fit a user's hand. In the illustrated example, the surface contour 1130 can have a highest height between the receptacles 1114, 1116 and a lowest height outside the receptacles 1114, 1116, with the surface contour 1130 angling downward toward an implant, such as staple 500, as one moves along the surface contour 1130 away from the highest height between the receptacles 1114, 1116. Thus, when placing an implant, such as staple 500, in contact with a first bone and a second bone, a user's hand can tamp the surface contour 1130 of the cap 1124 to apply an insertion force to the implant, such as staple 500.
[0130] The inserter 1100 can be configured to place an implant, such as a staple 500, into one or more bones. For example, the inserter 1100 can be operably connected to the staple 500 via a first coupling shaft 1102 and a second coupling shaft 1104, and a connector 1106 (e.g., a cap 1124) can be coupled to the first coupling shaft 1102 and the second coupling shaft 1104, as shown in the example of FIG. 11B. When the connector 1106 is coupled to the first coupling shaft 1102 and the second coupling shaft 1104, as shown in the example of FIG. 11B, the connector 1106 can be configured to bias the first coupling shaft 1102 and the second coupling shaft 1104 toward each other to apply a load force to the staple 500. When the first coupling shaft 1102 and the second coupling shaft 1104 are biased toward one another to apply a load force to the staple 500, the first leg 502 and the second leg 504 may be oriented generally parallel to one another, as shown in the example of FIG. 11B. Applying a load force to the staple 500 in this manner may cause the legs 502, 504 to move away from one another in generally parallel directions, which may be a configuration useful for inserting the staple 500 into and / or across a bone. Then, after the staple 500 has been inserted into and across a bone as desired, the connector 1106 may be removed from at least one of the first coupling shaft 1102 and the second coupling shaft 1104, allowing the first leg 502 and the second leg 504 to move toward one another. Specifically, removing the connector 1106 may cause the first leg 502 to move in a direction 1140 toward the second leg 504, and the second leg 504 to move in a direction 1142 toward the first leg 502.
[0131] 12A and 12B show another embodiment of an inserter 1200. FIG. 12A shows a side view of a longitudinal cross section of the inserter 1200, and FIG. 12B shows a bottom view of the cap 1201 of the inserter 1200. The inserter 1200 may be similar to or the same as the previously described inserter 1100, except as noted herein. For example, the inserter 1200 may include one or more (e.g., each) of the features disclosed herein with respect to the inserter 1100, except where otherwise noted.
[0132] The inserter 1200 may include a first coupling shaft 1102 and a second coupling shaft 1104, as shown in the inserter 1100. Similarly, the inserter 1200 may include a first wire-receiving opening 1110, a second wire-receiving opening 1112, a first receptacle 1114, and a second receptacle 1116. Compared to the inserter 1100, the inserter 1200 may further include a first wire-receiving sleeve 1210 extending from the first wire-receiving opening 1110 and a second wire-receiving sleeve 1212 extending from the second wire-receiving opening 1112. The wire-receiving sleeves 1210, 1212 may be elongated in a direction parallel to the longitudinal axis of the inserter 1200, facilitating additional stability and retention at the interface between the cap 1201 and the first and second wires received therein.
[0133] As shown in the illustrated embodiment of the inserter 1200, the first wire-receiving opening 1110 and the second wire-receiving opening 1112 can be included in an aligned arrangement. For example, the first wire-receiving opening 1110 and the second wire-receiving opening 1112 can have an aligned arrangement and spacing that corresponds to (e.g., matches) the arrangement and spacing of the first wire opening 902 and the second wire opening 904 of the guide 900. For example, the first wire-receiving opening 1110 and the second wire-receiving opening 1112 can be on a common side of the cap 1201 and disposed between the receptacles 1114 and 1116, respectively. Thus, the first wire-receiving opening 1110 and the second wire-receiving opening 1112 of the inserter 1200 can be configured to receive a first wire and a second wire disposed using the respective first wire opening 902 and second wire opening 904 of the guide 900.
[0134] 13A and 13B show yet another embodiment of an inserter 1300. FIG. 13A shows a perspective view of the inserter 1300, and FIG. 13B shows a bottom view of the cap 1301 of the inserter 1300. The inserter 1300 may be similar to or the same as the previously described inserter 1200, except as noted herein. For example, the inserter 1300 may include one or more (e.g., each) of the features disclosed herein with respect to the inserter 1200, except where otherwise noted.
[0135] The inserter 1300 may include a first coupling shaft 1102 and a second coupling shaft 1104 as shown for the inserter 1100, a first wire receiving opening 1110, a second wire receiving opening 1112, a first receptacle 1114, a second receptacle 1116, a first wire receiving sleeve 1210 extending from the first wire receiving opening 1110, and a second wire receiving sleeve 1212 extending from the second wire receiving opening 1112.
[0136] As shown in the illustrated embodiment of the inserter 1300, the first wire-receiving opening 1110 and the second wire-receiving opening 1112 can be included in an offset arrangement. For example, the first wire-receiving opening 1110 and the second wire-receiving opening 1112 can have an offset arrangement and spacing to correspond to (e.g., match) the arrangement and spacing of the first wire opening 902 and the second wire opening 904 of the guide 1000. For example, the first wire-receiving opening 1110 and the second wire-receiving opening 1112 can be on opposite sides of the cap 1301 and disposed between the receptacles 1114 and 1116, respectively. Thus, the first wire-receiving opening 1110 and the second wire-receiving opening 1112 of the inserter 1300 can be configured to receive a first wire and a second wire disposed using the respective first wire opening 902 and second wire opening 904 of the guide 1000.
[0137] 14 is a perspective view of an implant tamp feature 1400 that may be included, for example, in any one or more of inserter embodiments 1100, 1200, 1300. Implant tamp feature 1400 may be included, for example, at or near a distal end configured to contact and operably connect to an implant, such as staple 500, of any one or more of inserter embodiments 1100, 1200, 1300.
[0138] The implant tamp feature 1400 can include a first wall 1402, a second wall 1404, and an implant receiving slot 1406 defined between the first wall 1402 and the second wall 1404. As illustrated for the present embodiment, the implant receiving slot 1406 can be defined by a base surface 1407 extending a distance 1412 from the first wall 1402 to the second wall 1404. Each of the first wall 1402 and the second wall 1404 can extend outwardly from the base surface 1407, a proximal end 1408 of each wall 1402, 1404 can be at the base surface 1407, and a distal end 1410 of each wall 1402, 1404 can be spaced outwardly from the base surface 1407. The implant receiving slot 1406 can then be sized to receive an implant between the walls 1402, 1404. For example, if the implant is a staple 500, the implant receiving slot 1406 can be sized to receive the staple 500. In this example, the distance 1412 between the walls 1402, 1404, and thus defining the width of the implant receiving slot 1406, can be slightly larger than the bridge width 570 of the bridge 506 of the staple 500.
[0139] The implant tamp feature 1400 can be configured to transfer a tamping force applied by a user's hand at the inserter to an implant received in the implant receiving slot 1406. By restricting the implant, such as staple 500, to the distance 1412 of the implant receiving slot 1406 between the walls 1402, 1404, a greater tamping force can be transferred from the inserter to the implant, such as staple 500. Thus, the implant tamp feature 1400 can facilitate increased efficiency in inserting an implant, such as staple 500, in bone(s).
[0140] 15 is a flow diagram of an embodiment of method 1500. Method 1500 can be used, for example, as a surgical technique for placing implants, such as staples, to stabilize bones and facilitate fusion. Figures 16-21, referenced in conjunction with method 1500, provide exemplary illustrations of non-limiting embodiments of the steps of method 1500.
[0141] At step 1510, method 1500 may include inserting a seeker. For example, step 1510 may include inserting the seeker into a space (e.g., a joint) separating a first bone and a second bone. As an example, the first bone may be a metatarsal (e.g., first metatarsal), the second bone may be a cuneiform bone (e.g., medial cuneiform), and the space separating the first bone and the second bone may be a tarsometatarsal joint space separating the metatarsal and cuneiform bones.
[0142] 16 shows a side view of an embodiment of a seeker 1600 inserted into a space 1602 (e.g., a joint space such as the TMT joint space) separating a first bone 1604 (e.g., a metatarsal bone such as the first metatarsal) and a second bone 1606 (e.g., a cuneiform bone such as the medial cuneiform). As shown, the seeker 1600 can include a first portion 1610 and a second portion 1612. The first portion 1610 can be configured to be positioned within the space 1602 separating the first bone 1604 and the second bone 1606. The second portion 1612 can be configured to extend out of the space 1602 separating the first bone 1604 and the second bone 1606.
[0143] In the illustrated embodiment, the seeker 1600 is a wire. However, in other embodiments, other types of devices having a first portion configured to be positioned in the space 1602 separating the first bone 1604 and the second bone 1606 and a second portion configured to extend out of the space 1602 separating the first bone 1604 and the second bone 1606 can be used as the seeker 1600. In yet other examples, the seeker can be inserted into the joint space integrally attached to a corresponding guide.
[0144] At step 1520, method 1500 may include aligning a guide using the seeker inserted at step 1510. FIG. 17 is a side view of guide 900 aligned with first bone 1604 and / or second bone 1606 using seeker 1600. Step 1520 may include using seeker 1600 to align a guide, such as guide 900 or guide 1000, which may be any one of the guide embodiments disclosed herein. For ease of reference, reference is made to guide 900, although guide 1000 could alternatively be used as part of step 1520.
[0145] As described above, step 1520 may include aligning the guide 900 with the first bone 1604 and / or the second bone 1606 and / or the joint space between the bones using the seeker 1600. The guide 900 may define at least one wire opening 902, 904 and a seeker receiving opening 916 in a body 901 of the guide 900. Aligning the guide 900 with the first bone 1604 and / or the second bone 1606 may include (i) positioning the at least one wire opening 902, 904 over the first bone 1604 and / or the second bone 1606, and (ii) positioning the seeker receiving opening 916 of the guide 900 over a second portion 1612 of the seeker 1600 extending out from the space 1602. The second portion 1612 of the seeker 1600 may be received through the seeker receiving opening 916, and the first portion 1610 of the seeker 1600 may extend outside the seeker receiving opening 916 and reside within the space 1602. In this manner, positioning the seeker receiving opening 916 of the guide 900 over the second portion 1612 of the seeker 1600, which is itself at least partially inserted into the space 1602, may result in at least one wire opening 902, 904 of the guide 900 being positioned over at least one of the respective bones 1604, 1606.
[0146] In one example, the at least one wire opening 902, 904 includes a first wire opening 902 and a second wire opening 904. In such an example, disposing the at least one wire opening 902, 904 over the first bone 1604 and / or the second bone 1606 may include disposing the second wire opening 904 over the first bone 1604 and the first wire opening 902 over the second bone 1606. In this manner, disposing the seeker receiving opening 916 of the guide 900 over the second portion 1612 of the seeker 1600, which is itself at least partially inserted into the space 1602, may result in the second wire opening 904 being disposed over the first bone 1604 and the first wire opening 902 being disposed over the second bone 1606. A similar result can be achieved with respect to the drill guide openings 906, 908 of the guide 900 by positioning the seeker receiving opening 916 of the guide 900 over the second portion 1612 of the seeker 1600. That is, positioning the seeker receiving opening 916 of the guide 900 over the second portion 1612 of the seeker 1600, which is itself at least partially inserted into the space 1602, can result in the second drill guide opening 908 being positioned over the first bone 1604 and the first drill opening 906 being positioned over the second bone 1606.
[0147] The illustrated embodiment shows the seeker 1600 (e.g., a wire) as being separable from the guide 900, such that the seeker 1600 may be removably received in a seeker-receiving opening 916 of the guide 900. However, in other embodiments, the seeker 1600 may be connected to the guide 900, for example, as a type of keel component of the guide 900. In this integrated guide-seeker embodiment, inserting the seeker 1600 into the space 1602 separating the first bone 1604 and the second bone 1606 may include aligning the guide 900 with the first bone 1604 and / or the second bone 1606 using the seeker 1600 connected to the guide 900.
[0148] In step 1530, method 1500 may include inserting wire(s) into bone(s). For example, step 1530 may include inserting a first wire 1570 into a first bone 1604 and a second wire 1572 into a second bone 1606 separated from the first bone 1604 by a space 1602. As a more specific such example, step 1530 may include inserting the first wire 1570 into the first bone 1604 and the second wire 1572 into the second bone 1606 using at least one wire opening 902, 904. For example, as shown in the example of FIG. 17 , the first wire 1570 can be inserted into the first bone 1604 through the second wire opening 904, and the second wire 1572 can be inserted into the second bone 1606 through the first wire opening 902. After aligning the guide using the seeker in step 1520, the first wire 1570 may be inserted through the second wire opening 904 into the first bone 1604, and the second wire 1572 may be inserted through the first wire opening 902 into the second bone 1606. Thus, as described above, positioning the seeker receiving opening 916 of the guide 900 over the second portion 1612 of the seeker 1600, which is itself at least partially inserted into the space 1602, may result in the second wire opening 904 of the guide 900 being positioned over the first bone 1604 and the first wire opening 902 of the guide 900 being positioned over the second bone 1606, thereby facilitating accurate insertion of the first wire 1570 through the second wire opening 904 into the first bone 1604 and the second wire 1572 through the first wire opening 902 into the second bone 1606.
[0149] Further embodiments of method 1500 may include drilling one or more implant holes in one or more bones, for example, after aligning the guide using the seeker in step 1520 and / or after inserting a wire into the bone using the guide in step 1530.
[0150] 18 is a side view of a guide 900 used as a drill guide. In particular, the drill guide 900 can be used to drill a first implant hole 1802 in a first bone 1604 and a second implant hole 1804 in a second bone 1606. A drill member 1806 can be inserted into the second drill guide opening 908 to drill the first implant hole 1802 in the first bone 1604, and a drill member can be inserted into the first drill guide opening 906 to drill the second implant hole 1804 in the second bone 1606. The first implant hole 1802 and the second implant hole 1804 can be drilled using the drill guide 900, for example, before or after the first wire 1570 is inserted through the second wire opening 904 into the first bone 1604 and / or when the second wire 1572 is inserted through the first wire opening 902 into the second bone 1606. The first implant hole 1802 and the second implant hole 1804 can be drilled and the size of the drill member selected such that the first implant hole 1802 and the second implant hole 1804 are dimensioned to accommodate at least a portion of the leg end of a staple (e.g., at least a portion of the end 537 of the leg 502 of the staple 500).
[0151] Another further embodiment of method 1500 may include removing the seeker, for example, after aligning the guide using the seeker in step 1520, after inserting a wire into the bone using the guide in step 1530, and / or after drilling the first implant hole 1802 and the second implant hole 1804 using the drill guide 900. As one such example, the seeker may be removed from the space separating the first and second bones, and the guide may be removed from the first and second wires, before aligning an inserter operably connected to the implant with the first and second wires in step 1540.
[0152] In step 1540, method 1500 may include aligning the inserter with the wire(s) inserted into the bone(s) in step 1530. Figures 19A and 19B show components of inserter 1100 aligned with wire(s) 1570, 1572 in first bone 1604 and / or second bone 1606 shown in Figure 19C. Figure 19A is an elevational view of inserter 1100 coupled to the top surface of an implant, in the illustrated example, staple 500. Figure 19B is a perspective view showing connector 1106 alone, which in this example is a component of inserter 1100. Figure 19C is an elevational view of wires 1570, 1572 in first bone 1604 and second bone 1606 for use in aligning inserter 1100. Step 1540 may include aligning the wires 1570, 1572 inserted into the bones 1604, 1606 in step 1530 with an inserter, such as any one of the inserter embodiments disclosed herein, for example, inserter 1100, inserter 1200, or inserter 1300. While reference is made to inserter 1100 here for ease of reference, use of inserter 1200 or 1300 may alternatively be part of step 1540.
[0153] 19A , the inserter aligned in step 1540 can be operably connected to an implant, such as a staple 500. Step 1540 can include aligning the inserter 1100, which is operably connected to an implant, such as a staple 500, with the first wire 1570 and the second wire 1572 by placing at least the first wire 1570 in a first wire-receiving opening 1110 of the connector 1106 of the inserter 1100 and the second wire 1572 in a second wire-receiving opening 1112 of the connector 1106 of the inserter 1100.
[0154] In the illustrated example, where the implant is a staple 500, the implant can include a first leg 502, a second leg 504, and a bridge 506 connecting the first leg 502 and the second leg 504. The staple can further include an upper surface 526 and a bottom surface 528, and the inserter can be operatively connected to the staple 500 at a location of the staple 500 spaced from the bottom surface 528, such as via a first coupling shaft 1102 and a second coupling shaft 1104. For example, the inserter 1100 can be operatively connected to the staple 500 at a location of the staple 500 that is between the upper surface 526 and the lower surface 528. More specifically, the first coupling shaft 1102 of the inserter 1100 can be connected to the first leg 502 of the staple 500 at a position between the bottom surface 528 and the top surface 526, and the second coupling shaft 1104 of the inserter 1100 can be connected to the second leg 504 of the staple 500 at a position between the bottom surface 528 and the top surface 526.
[0155] In addition to the inserter 1100 being operably coupled to the staple 500 when aligning the inserter 1100 with the wires 1570, 1570 in step 1540, the inserter 1100 can have a connector 1106 that couples the first coupling shaft 1102 and the second coupling shaft 1104. For example, the connector 1106 can be connected to the first coupling shaft 1102 and the second coupling shaft 1104 to connect the first coupling shaft 1102 and the second coupling shaft 1104 before placing the first wire 1570 in the first wire-receiving opening 1110 of the connector 1106 and the second wire 1572 in the second wire-receiving opening 1112 of the connector 1106. In the illustrated embodiment of the inserter 1100, the connector 1106 can connect the first coupling shaft 1102 and the second coupling shaft 1104 by receiving the first coupling shaft 1102 in a first receptacle 1114 of the connector 1106 and receiving the second coupling shaft 1104 in a second receptacle 1116 of the connector 1106, thereby coupling the first coupling shaft 1102 and the second coupling shaft 1104.
[0156] When the connector 1106 is connected to the first coupling shaft 1102 and the second coupling shaft 1104, thereby coupling the first coupling shaft 1102 and the second coupling shaft 1104, a loading force can be applied to the staple 500 operably connected to the inserter 1100. For example, when the staple 500 is in its natural state, and when the first coupling shaft 1102 and the second coupling shaft 1104 are operably connected to the staple 500, the first coupling shaft 1102 and the second coupling shaft 1104 can be oriented at an oblique angle relative to one another, an example of which is shown for the staple 500 in FIG. 19A . Next, by connecting the connector 1106 to the first coupling shaft 1102 and the second coupling shaft 1104, a load force can be applied to move the first coupling shaft 1102 in direction 1902 and the second coupling shaft 1104 in direction 1904, thereby moving the first coupling shaft 1102 and the second coupling shaft 1104 closer to each other.
[0157] Because the first coupling shaft 1102 and the second coupling shaft 1104 are operatively connected to the staple 500, this movement of the first coupling shaft 1102 in direction 1902 and the second coupling shaft 1104 in direction 1904 can transfer a load force applied to the first coupling shaft 1102 and the second coupling shaft 1104 by the connector 1106 to the staple 500. As a result of this load force being applied to the staple 500, the staple 500 can transition from a natural state, an example of which is shown for the staple 500 in FIG. 19A , to a deformed, inserted state, an example of which is shown for the staple 500 in FIG. 20 , when the connector 1106 is applied to couple the first coupling shaft 1102 and the second coupling shaft 1104 to apply a load force.
[0158] When the staple 500 is in the deformed insertion state, the first leg 502 and the second leg 504 can be oriented more nearly parallel to one another than when the staple 500 is in the biased compression-induced state. The deformed insertion state, in which the first leg 502 and the second leg 504 are oriented generally parallel to one another, can be a useful orientation for inserting the staple 500 into the bones 1604, 1606 (e.g., step 1550). On the other hand, the biased compression-induced state, in which the first leg 502 and the second leg 504 are generally close together and pointing toward one another at an oblique angle, can be a useful orientation after the staple 500 has been inserted into the bones 1604, 1606 and applied a compressive force to each bone 1604, 1606 and across the space between the bones 1604, 1606 (e.g., after the staple 500 has been deployed in step 1550, removing the connectors). Thus, in step 1540, when the inserter 1100 is aligned with the wires 1570, 1572 (e.g., when the first wire receiving opening 1110 receives the wire 1570 and the second wire receiving opening 1112 receives the wire 1572), the connector 1106 can also receive the first coupling shaft 1102 (e.g., at the receptacle 1114) and the second coupling shaft 1104 (e.g., at the second receptacle 1116), and the staple 500 is in a deformed inserted state.
[0159] In step 1550, the method 1500 may include advancing the inserter aligned in step 1540 along the wire(s) to place implants such as staples 500. Figure 20 is a side view of the assembled inserter 1100 advanced along the wires 1570, 1572 to place the staples 500 in contact with the first bone 1604 and the second bone 1606.
[0160] As mentioned above, in one example, step 1550 may include advancing the inserter 1100 along the first wire 1570 and the second wire 1572 to place the staple 500 in contact with the first bone 1604 and the second bone 1606 such that the bridge 506 of the staple 500 spans the space 1602 between the first bone 1604 and the second bone 1606. In this manner, advancing the inserter 1100 along the first wire 1570 and the second wire 1572 to place the staple 500 in contact with the first bone 1604 and the second bone 1606 may include placing the first leg 502 in the first implant hole 1802 in the first bone 1604 and placing the second leg 504 in the second implant hole 1804 in the second bone 1606. In this manner, advancing the inserter 1100 along the first wire 1570 and the second wire 1572 to place the staple 500 in contact with the first bone 1604 and the second bone 1606 can also include contacting the first bone 1604 and the second bone 1606 with the bottom surface 528 of the staple 500. In one particular such example, contacting the first bone 1604 and the second bone 1606 with the bottom surface 528 of the staple 500 can include contacting the first bone 1604 generally flush with the bottom surface 528 and contacting the second bone 1606 generally flush with the bottom surface 528.
[0161] As described above, when the inserter 1100 is aligned with the wires 1570, 1572 (e.g., when the first wire-receiving opening 1110 receives the wire 1570 and the second wire-receiving opening 1112 receives the wire 1572), the connector 1106 also receives the first coupling shaft 1102 (e.g., at the first receptacle 1114) and the second coupling shaft 1104 (e.g., at the second receptacle 1116), and the staples 500 can be in a deformed, inserted state. Similarly, when the inserter 1100 is moved along the wires 1570, 1572 to deploy the staples 500 in step 1550, the staples 500 can be in a deformed, inserted state (e.g., by coupling and maintaining the connector 1106 to the first coupling shaft 1102 and the second coupling shaft 1104). As can be seen from the exemplary deformed insertion state of the staple 500 shown in FIG. 20, when the connector 1106 is coupled to the first coupling shaft 1102 and the second coupling shaft 1104 and the inserter 1100 advances along the wires 1570, 1572, the first leg 502 can become approximately parallel to the second leg 504.
[0162] In a further embodiment, method 1500 can further include the step of detaching the connector from the inserter. For example, when included in method 1500, the step of detaching the connector from the inserter can be performed after the inserter has been advanced over the wire and the implant has been placed in the target anatomy in step 1550. FIG. 21 is a side view of inserter 1100 with connector 1106 removed, facilitating the fixation of the implant (e.g., staple 500) between the first bone 1604 and the second bone 1606 and applying a compressive force to the first bone 1604 and the second bone 1606.
[0163] After the inserter 1100 is advanced along the first wire 1570 and the second wire 1572 to place the staple 500 in contact with the first bone 1604 and the second bone 1606, the connector 1106 can be removed from the inserter 1100, thereby removing the load force applied by the connector 1106 and moving the first coupling shaft 1102 and the second coupling shaft 1104 away from each other. The first coupling shaft 1102 can move in a direction 1906 (e.g., a direction opposite to the direction 1902 that the first coupling shaft 1102 moves when the connector 1106 couples the first coupling shaft 1102 to the second coupling shaft 1104), and the second coupling shaft 1104 can move in a direction 1908 (e.g., a direction opposite to the direction 1904 that the second coupling shaft 1104 moves when the connector 1106 couples the second coupling shaft 1104 to the first coupling shaft 1102). Further, if included in the method 1500, the step of detaching the connector 1106 from the inserter 1100 can be performed after the first leg 502 is positioned in the first implant hole 1802 of the first bone 1604 and after the second leg 504 is positioned in the second implant hole 1804 of the second bone 1606. In an additional example, the step of removing the connector 1106 from the inserter 1100 can be performed after the bottom surface 528 of the staple 500 is placed in contact with the first bone 1604 and the second bone 1606. In yet another example, the step of removing the connector 1106 from the inserter 1100 can be performed before the first coupling shaft 1102 and the second coupling shaft 1104 are removed from their actuating coupling to the staple 500.
[0164] In one example, to facilitate removal of the connector 1106, the first coupling shaft 1102 and the second coupling shaft 1104 can be moved toward each other (e.g., the first coupling shaft 1102 can be moved in a direction opposite to direction 1906 and the second coupling shaft 1104 can be moved in a direction opposite to direction 1908) before removing the connector 1106, thereby facilitating disengagement of the first coupling shaft 1102 and the second coupling shaft 1104 from the connector 1106. For example, moving the first coupling shaft 1102 and the second coupling shaft 1104 toward each other may prompt the first retaining feature 1126, if so included in the first coupling shaft 1102, to disengage from the first receptacle 1114 (e.g., disengage the first retaining feature 1126 from the first retaining mating feature 1127 in the first receptacle 1114), and may prompt the second retaining feature 1128, if so included in the second coupling shaft 1104, to disengage from the second receptacle 1116 (e.g., disengage the second retaining feature 1128 from the second retaining mating feature 1129 in the second receptacle 1116).
[0165] When the connector 1106 is removed from the first coupling shaft 1102 and the second coupling shaft 1104 that are operably connected to the staple 500, the first leg 502 of the staple 500 and the second leg 504 of the staple 500 can return to a natural state, as shown in FIG. 21 . This can include a state in which the first leg 502 and the second leg 504 are generally diagonally positioned such that the central longitudinal axes of the legs 502 intersect. Additionally, because the connector 1106 is in the process of being removed from the first coupling shaft 1102 and the second coupling shaft 1104 that are operably connected to the staple 500, the first leg 502 and the second leg 504 can gradually move toward each other as the connector 1106 is being removed. Removal of connector 1106 can cause the staple legs to return to their original position from their deformed position; for example, the bone into which the staple legs are inserted may prevent the legs from fully returning to their original, undeformed position, resulting in the staple applying a compressive force across the end face of the bone.
[0166] In some embodiments, multiple implants can be placed in accordance with the teachings disclosed herein. For example, in one embodiment, at least two implants (e.g., two staples) can be placed in and across the bones 1604, 1606 in accordance with the teachings disclosed herein. This can include, for example, placing one staple across the medial cuneiform, first metatarsal, and dorsal TMT joint, and another staple across the medial cuneiform, first metatarsal, and medial TMT joint. When placing at least two such implants in and across the bones 1604, 1606 in accordance with the teachings disclosed herein, related techniques may further include making a first incision at a first anatomical location (e.g., the medial cuneiform, adjacent to the first metatarsal and dorsally across the TMT joint) and making a second, different incision at a second, different anatomical location (e.g., the medial cuneiform, adjacent to the first metatarsal and medially across the TMT joint) prior to placing such implants in the bones 1604, 1606.
[0167] 22A-25B illustrate additional embodiments of staples as one exemplary type of implant that can be used to secure and fuse bones, as described elsewhere herein. In certain embodiments, the staple embodiments illustrated and described with respect to FIGS. 22A-25B can include any one or more features (e.g., each feature) illustrated and / or described elsewhere herein with respect to orthopedic implants, including those with respect to staple embodiments illustrated and / or described elsewhere herein. The staple embodiments illustrated and described with respect to FIGS. 22A-25B can include one or more fixation apertures, each of which can be configured to receive a fixation member, and, in some embodiments, can include one or more anatomical contouring features. The presence of one or more fixation apertures and / or one or more anatomical contouring features in a staple can help provide increased stability of the staple in one or more bones when implanted, which can be useful for improving the resulting anatomical alignment correction and / or fusion facilitated, at least in part, by implantation of a given staple embodiment.
[0168] 22A and 22B illustrate an embodiment of an orthopedic implant in the form of a staple 2200 including one or more fixation apertures. FIG. 22A is a perspective view of this embodiment of staple 2200 showing fixation apertures 2250, 2252, and FIG. 22B is a perspective view of this embodiment of staple 2200 showing fixation members 2254, 2256 disposed in fixation apertures 2250, 2252, respectively. As described elsewhere herein, staple 2200 can be configured to apply a compressive force across bones and spaces between bones (e.g., joints) for use in bone fixation and fusion. Staple 2200 can include any one or more features (e.g., each feature) illustrated and / or described elsewhere herein with respect to the orthopedic implant, including with respect to other staple embodiments illustrated and / or described elsewhere herein.
[0169] The staple 2200 can include a staple body 2201 with a first leg 2202, a second leg 2204, and a bridge 2206. In the illustrated embodiment, the staple 2200 includes the first leg 2202 on a first side 2203 of the staple 2200 and the second leg 2204 on a second side 2205 of the staple 2200. In this example, the first side 2203 is opposite the second side 2205. The bridge 2206 can connect the first side 2203 and the second side 2205, and thus, for example, can connect the first leg 2202 and the first fixation opening 2250 to the second leg 2204 and the second fixation opening 2252.
[0170] As described above, the staple 2200 can further include one or more fixation openings 2250, 2252. Each of the one or more fixation openings 2250, 2252 can be configured to receive a respective fixation member 2254, 2256 (e.g., a bone screw) therein (e.g., through therethrough). The fixation openings 2250, 2252 can receive a respective fixation member 2254, 2256, which extends from the bottom surface 2228 of the staple body 2201 through the fixation openings 2250, 2252. To accommodate a respective fixation member 2254, 2256, each fixation opening 2250, 2252 can include a respective complementary coupling element 2251, 2253 that can be configured to couple to the fixation member. For example, as shown here, fixation opening 2250 can include a first complementary coupling element 2251 in the form of one of male and female threads configured to complement and couple with the other of the male and female threads included in coupling element 2254, and fixation opening 2252 can include a second complementary coupling element 2253 in the form of male or female threads configured to complement and couple with the other of the male and female threads included in coupling element 2256. Thus, fixation opening 2250 can be configured to currently receive and couple fixation member 2254 (e.g., a first bone screw), and fixation opening 2252 can be configured to currently receive and couple fixation member 2256 (e.g., a second bone screw). Depending on the orientation of the fixation openings 2250, 2252 relative to the body 2201, the staple 2200 can be configured so that the fixation member 2254 extends parallel to the legs 2202 and the fixation member 2256 extends parallel to the legs 2204, or so that the fixation member 2254 extends at an angle relative to the legs 2202 and the fixation member 2256 extends at an angle relative to the legs 2204.
[0171] 22A and 22B , the staple 2200 includes locking openings 2250, 2252 on the inside of the legs 2202, 2204 (e.g., relative to the longitudinal length of the staple 2200). In particular, the staple 2200 can have the legs 2202 and locking opening 2250 on a first side 2203 with the locking opening 2250 closer to the bridge 2206 than the legs 2202, when measured along the longitudinal length of the staple 2200, and the staple 2200 can have the legs 2204 and locking opening 2252 on a second side 2205 with the locking opening 2252 closer to the bridge 2206 than the legs 2204, when measured along the longitudinal length of the staple 2200. For example, as disclosed elsewhere herein, legs 2202 and fixation openings 2250, and therefore first side 2203 of staple 2200, can be configured to be placed on a first bone, and legs 2204 and fixation openings 2252, and therefore second side 2205 of staple 2200, can be configured to be placed on a second bone (e.g., a second bone different from the first bone, or a fragment / portion of the first bone) to apply compression across a space separating a first bone and a second bone.
[0172] 23A and 23B illustrate an embodiment of an orthopedic implant in the form of a staple 2300 including one or more fixation apertures. Staple 2300 may be similar to or identical to staple 2200 illustrated and described with respect to FIGS. 22A and 22B, except as otherwise illustrated and described herein with respect to FIGS. 23A and 23B. As such, like reference characters are used to indicate like elements. FIG. 23A is a perspective view of this embodiment of staple 2300 showing fixation apertures 2250, 2252, and FIG. 23B is a perspective view of this embodiment of staple 2300 showing fixation members 2254, 2256 disposed in fixation apertures 2250, 2252. Staple 2300 may include any one or more features (e.g., each feature) illustrated and / or described elsewhere herein with respect to the orthopedic implant, including those with respect to other staple embodiments illustrated and / or described elsewhere herein.
[0173] Similar to staple 2200, staple 2300 includes a first leg 2202 and a locking opening 2250 on a first side 2203 and a second leg 2204 and a locking opening 2252 on a second side 2205. However, staple 2300 differs from staple 2200 in the arrangement of legs 2202, 2204 and locking openings 2250, 2252. That is, as shown in FIGS. 23A and 23B , staple 2300 includes locking openings 2250, 2252 on the outer sides of legs 2202, 2204 (e.g., relative to the longitudinal length of staple 2300). In particular, staple 2300 can have legs 2202 and fixation opening 2250 on a first side 2203 with legs 2202 closer to bridge 2206 than to fixation opening 2250 when measured along the longitudinal length of staple 2300, and staple 2300 can have legs 2204 and fixation opening 2252 on a second side 2205 with legs 2204 closer to bridge 2206 than to fixation opening 2252 when measured along the longitudinal length of staple 2300. For example, as disclosed elsewhere herein, legs 2202 and fixation openings 2250, and thus first side 2203 of staple 2300, can be configured to be placed on a first bone, and legs 2204 and fixation openings 2252, and thus second side 2205 of staple 2300, can be configured to be placed on a second bone (e.g., a second bone different from the first bone, or a fragment / portion of the first bone) to apply compression across a space separating a first bone and a second bone.
[0174] 24A and 24B illustrate a further embodiment of an orthopedic implant in the form of a staple 2400 including a fixation aperture and a particular exemplary anatomical contour. FIG. 24A is a side view of this embodiment of staple 2400 illustrating the exemplary anatomical contour, and FIG. 24B is a side view illustrating such an embodiment of staples 2400A, 2400B with the exemplary anatomical contour positioned across a space (e.g., a joint space) separating a first bone 1604 and a second bone 1606. As shown in FIG. 24B, staple 2400B can be a mirror image configuration of staple 2400A. Staple 2400 can include any one or more features (e.g., each feature) illustrated and / or described elsewhere herein with respect to an orthopedic implant, including those with respect to other staple embodiments illustrated and / or described elsewhere herein. For example, staple 2400 can be the same as staple 2300 but have the anatomical contour described herein with respect to FIGS. 24A and 24B. In certain embodiments, staple 2400 can include anatomical contours such that staple 2400 is anatomically fitted, similar to or identical to those disclosed with respect to anatomically fitted contours of an implant (e.g., a bone plate) in U.S. Provisional Patent Application No. 63 / 313,162, filed February 23, 2022, and entitled "Anatomically-Fitted Tarsometatarsal Bone Plate," the entire contents of which are incorporated herein by reference.
[0175] Staple 2400 can be an anatomically adapted staple that is geometrically configured to fit the anatomical shape of a particular bone or bones. By way of example, staple 2400 can be anatomically adapted for a metatarsal fixation procedure, where staple 2400 includes one or more geometric features that are complementary to the anatomical shape of a cuneiform bone (e.g., medial cuneiform) and / or a metatarsal bone (e.g., first metatarsal).
[0176] Staple 2400 can include a body 2402. Body 2402 can include a proximal body region 2404 (2404A of staple 2400A, 2404B of staple 2400B), a distal body region 2406 (2406A of staple 2400A, 2406B of staple 2400B), and a bridge 2408 (2408A of staple 2400A, 2408B of staple 2400B). Proximal body region 2404 can be configured to be positioned over a cuneiform bone, such as the medial cuneiform bone, shown as bone 1606 in FIG. 24B. Distal body region 2406 can be configured to be positioned over a metatarsal bone, such as the first metatarsal bone, shown as bone 1604 in FIG. 24B. Bridge 2408 can extend between proximal body region 2404 and distal body region 2408. The bridge 2408 can be configured to be positioned across the tarsometatarsal joint, which separates the metatarsals and cuneiform bones. The bridge 2408 can define a bridge central longitudinal axis 2410. The body 2402 can have a width 2412 that defines the extent of the bone plate 2400 across the bridge central longitudinal axis 2410. Further, the body 2402 can include an upper surface 2414 and a bone-facing surface 2416 opposite the upper surface 2414. The staple 2400 can also include fixation holes 2250, 2252 and legs 2202, 2204, as described elsewhere herein, including the fixation holes 2250 and legs 2202 in the distal body region 2406 and the fixation holes 2252 and legs 2204 in the proximal body region 2404. Generally, the body of the staple 2400 can include at least one fixation hole extending through the proximal body region 2404 and one leg in this region, and at least one fixation hole extending through the distal body region 2406 and one leg in this region.
[0177] To facilitate facilitating the anatomical fit of the staple 2400 to one or more bones, the body 2402 can define the staple 2400 as an asymmetric staple. In particular, the staple 2400 can be contoured to complement the target anatomical structure of one or more bones and / or adjacent joint space(s) into which the staple 2400 is positioned and secured. To complement the target anatomical structure, the staple 2400 can include a fixation hole 2252 that is asymmetrically oriented relative to one or more other fixation holes (e.g., relative to fixation hole 2250). In particular, the staple 2400 can include a fixation hole 2252 in the proximal body region 2404 with this asymmetric orientation, such that the fixation hole 2252 complements the native anatomical structure present in a cuneiform bone (e.g., present in the medial cuneiform bone) and / or the joint space between adjacent cuneiform bones (e.g., the joint space adjacent the medial cuneiform bone and the middle cuneiform bone). The fixation holes 2252 can be offset from the bridge central longitudinal axis 2410, with the fixation holes 2250 being positioned at the bridge central longitudinal axis 2410. More specifically, in some examples, as best shown in FIG. 24B , the fixation holes 2250, the legs 2202B, and the legs 2404A can each be positioned flush with the bridge central longitudinal axis 2410, while the fixation holes 2252 are offset in one or more planes (e.g., multiple planes) from the bridge central longitudinal axis 2410. Thus, the asymmetric orientation of the fixation holes 2252 can facilitate providing the staple 2400 as an anatomically compatible staple that complements the native anatomy present in the cuneiform bone, such that the fixation holes 2452 are positioned with consideration for the native anatomy of the cuneiform bone to promote robust fixation of the fixation screws in that native anatomy, thereby avoiding inadvertent placement of the fixation screws in the joint space.
[0178] 25A and 25B illustrate another embodiment of an orthopedic implant in the form of a staple 2500 including a fixation aperture and a particular exemplary anatomical contour. FIG. 25A is a side view of this embodiment of staple 2500 illustrating the exemplary anatomical contour, and FIG. 25B is a side view illustrating such an embodiment of staple 2500 with the exemplary anatomical contour positioned across a space (e.g., a joint space) 1605 separating a first bone 1604 and a second bone 1606. Staple 2500 can include any one or more features (e.g., each feature) illustrated and / or described elsewhere herein with respect to orthopedic implants, including those with respect to other staple embodiments illustrated and / or described elsewhere herein. For example, staple 2500 can be the same as staple 2300 but have the anatomical contour described herein with respect to FIGS. 25A and 25B. In certain embodiments, the staple 2500 can include an anatomical contour such that the staple 2500 is anatomically conforming, similar to or identical to that disclosed with respect to the anatomically conforming contour of an implant (e.g., a bone plate) in U.S. Provisional Patent Application No. 63 / 151,041, entitled "System and Technique for Metatarsal Realignment with Reduced Incision Length."
[0179] The staple 2500 can be an anatomically adapted staple that is geometrically configured to fit the anatomical shape of a particular bone or bones. By way of example, the staple 2500 can be anatomically adapted for a metatarsal fixation procedure, where the staple 2500 includes one or more geometric features that are complementary to the anatomical shape of a cuneiform bone (e.g., the medial cuneiform) and / or a metatarsal bone (e.g., the first metatarsal). The bridge 2206 can be configured to be positioned across a space 1605, such as the tarsometatarsal joint separating the metatarsal and cuneiform bones, and the bridge 2206 can define a bridge central longitudinal axis 2410. The illustrated embodiment of staple 2500 has a generally U-shaped profile to provide anatomical contours in both the proximal body region 2404, which may have anatomical contours configured to conform to the bone 1606 (e.g., the medial cuneiform bone), and the distal body region 2406, which may have anatomical contours configured to conform to the bone 1604 (e.g., the first metatarsal bone). Thus, for staple 2500, each of the proximal body region 2404 and the distal body region 2406 can diverge and at least partially offset from the bridge central longitudinal axis 2410. Staple 2500 further includes fixation holes 2250, 2252 and legs 2202, 2204, as described elsewhere herein, including the fixation holes 2250 and legs 2202 in the distal body region 2406 and the fixation holes 2252 and legs 2204 in the proximal body region 2404. Generally, the staple 2201 can include at least one fixation hole extending through the proximal body region 2404 and one leg in this region, and at least one fixation hole extending through the distal body region 2406 and one leg in this region.
[0180] To help facilitate anatomical fit of staple 2500 to one or more bones, body 2201 can define staple 2500 as an asymmetric staple. In particular, staple 2500 can be contoured to complement the target anatomy of one or more bones and / or adjacent joint space(s) into which staple 2500 is to be placed and secured. To complement the target anatomy, staple 2500 can include (i) fixation holes 2250 that are asymmetrically oriented relative to bridge 2206 and / or legs 2202, and (ii) fixation holes 2252 that are asymmetrically oriented relative to bridge 2206 and / or legs 2204. In particular, the staple 2500 can include a fixation hole 2250 in this asymmetrical orientation in the distal body region 2406, where the fixation hole 2250 complements the natural anatomical structure present in the metatarsal bone (e.g., present in the first metatarsal bone), and the staple 2500 can include a fixation hole 2252 in this asymmetrical orientation in the proximal body region 2404, where the fixation hole 2252 complements the natural anatomical structure present in the cuneiform bone (e.g., present in the medial cuneiform bone). To form the generally U-shaped configuration of the body 2201 of the staple 2500, each of the fixation holes 2250 and 2252 can be offset from the bridge center longitudinal axis 2410 (e.g., the bridge center longitudinal axis 2410 does not intersect either of the fixation holes 2250 or 2252). More specifically, in some examples, each of the fixation holes 2250, 2252 can be offset divergently from the bridge central longitudinal axis 2410 on the same side of the bridge central longitudinal axis 2410. However, the staple 2500 can be symmetrical about each "half" of the U-shape about a radial plane extending radially through the center of the bridge 2206 and perpendicular to the bridge central longitudinal axis 2410. The anatomical contours included in the staple 2500 can facilitate providing the staple 2500 as an anatomically compatible staple that complements the native anatomical structures present in two or more bones (e.g., the medial cuneiform and the first metatarsal) to help avoid inadvertent placement of the fixation screw in the joint space and to position the fixation holes 2250, 2252 with consideration for the native anatomical structures of the two bones to promote robust fixation of the fixation screw in that native anatomical structure.
[0181] Staples constructed in accordance with the teachings described herein, when implemented with one or more fixation openings configured to receive one or more corresponding screws, can have any suitable number or arrangement of legs and bone screws. Generally, a staple can have at least one leg on a first side of a bridge and at least one leg on a second side of the bridge, the two legs being separated by the length of the bridge. A staple may have only one fixation opening configured to receive a screw (e.g., a fixation opening configured to be placed on a metatarsal or cuneiform bone with a fixation screw inserted therein, without the fixation opening being placed on another bone). A staple may have multiple fixation openings, each configured to receive a screw.
[0182] When multiple fixation openings are configured, the multiple fixation openings can be located on one side of the bridge of the staple (e.g., two or more fixation openings configured to be located over a metatarsal or cuneiform bone into which a fixation screw is inserted, with no fixation openings located over the other bone). Alternatively, the staple can have at least one fixation opening on a first side of the bridge and at least one fixation opening on a second side of the bridge. The relative positions of the staple legs to the one or more fixation openings and the bridge can vary. In some examples, the staple includes one or more fixation openings located between the legs closest to the bridge and the bridge itself. Additionally or alternatively, the staple can include one or more fixation openings located farther from the bridge than the legs closest to the bridge.
[0183] When one or more fixation openings are configured, the one or more fixation openings can be configured to receive a locking screw (e.g., a screw with threads around its head that screws into corresponding threads around the fixation opening) or a compression screw (e.g., a screw with no threads on its head that the fixation opening does not have threads into which the screw head screws). When multiple fixation openings are configured, all of the multiple fixation openings can be configured to receive a locking screw, all of the multiple fixation openings can be configured to receive a compression screw, or a combination of one or more fixation openings configured to receive a locking screw and one or more fixation openings configured to receive a compression screw can be used. One or more fixation openings and corresponding screws can be configured as monoaxial, where the screw is configured to be inserted only in a single axial direction, or one or more fixation openings and corresponding screws can be configured as polyaxial, where the screw can be inserted in a selected one of multiple different axial trajectories.
[0184] In use, a clinician can prepare, align, and / or insert one or more legs of a staple into corresponding holes in a bone as described herein. Before or after placing the legs of the staple into the bone portions, the clinician can drill one or more bone holes in each bone portion underlying the one or more fixation holes of the staple. The clinician can then insert fixation members (e.g., screws) into the corresponding fixation openings in the staple and the bone portion below them.
[0185] 26A-27D illustrate additional embodiments of inserter coupling shafts including multi-piece assemblies for use as components of inserter embodiments for placing orthopedic implants, e.g., as described elsewhere herein. In certain embodiments, the multi-piece inserter coupling shaft embodiments illustrated and described with respect to FIGS. 26A-27D can include any one or more features (e.g., each feature) illustrated and / or described elsewhere herein with respect to the inserter coupling shaft and / or inserter more generally. For example, the inserter coupling shaft embodiments illustrated and described with respect to FIGS. 26A-27D can be useful for facilitating coupling of the inserter coupling shaft embodiments to an implant (e.g., a staple) without the inserter coupling shaft embodiment protruding from a bottom surface of the implant, and for promoting a flush contact interface between the implant and the surface(s) of the bone(s) into which the implant is to be placed using an inserter including such coupling shaft embodiments.
[0186] Figures 26A and 26B illustrate an embodiment of a multi-piece inserter coupling shaft 2600. Figure 26A is an exploded elevation view of this inserter coupling shaft 2600 embodiment, and Figure 26B is an assembled view of this inserter coupling shaft 2600 embodiment. The inserter coupling shaft 2600 can have any one or more features (e.g., each feature) shown and / or described elsewhere herein with respect to inserter coupling shaft embodiments, including features or use as part of inserter embodiments more generally, unless otherwise described herein. As such, like reference characters are used to indicate like elements.
[0187] The inserter coupling shaft 2600 can be configured to operably connect to a connector (e.g., connector 1106) that is part of the inserter, and multiple (e.g., two) coupling shafts 2600 can be selectively coupled to each other, as described elsewhere herein. For example, the proximal end 1120 of the inserter coupling 2600 can be configured to be removably received in and used with a connector, as described elsewhere herein. To facilitate more secure removably coupling of the coupling shaft 2600 to the connector, the coupling shaft 2600 can include a retention feature 1126. The retention feature 1126 can be located at or near the proximal end 1120 of the coupling shaft 2600. The retention feature 126 can be configured to facilitate retention of the coupling shaft 2600 in a receptacle of the connector (e.g., a retaining mating feature of the receptacle of the connector), for example, as described elsewhere herein.
[0188] The inserter coupling shaft 2600 can be further configured to operably connect to an implant, such as a staple. In particular, the coupling shaft 2600 can be configured to operably couple to a staple with a staple handling coupling. For example, the coupling shaft 2600 can have a distal end 1103 that can include an implant coupling member 1107 (e.g., including threads complementary to threads of a staple handling coupling or other type of mechanical connection). The coupling member 1107 of the distal end 1103 of the coupling shaft 2600 can be configured to operably connect to a complementary coupling member of the staple handling coupling. In this manner, embodiments of the inserter can include the coupling shaft 2600 connected to an implant, such as a first side of a staple.
[0189] When operably connected to a staple, the coupling shaft 2600 can be configured to couple to the handling coupling receptacles of the staple at a location between the top surface of the staple and the bottom surface of the staple. For example, the coupling shaft 2600 can be operably coupled to each handling coupling of the staple in a direction moving from the top surface of the staple toward the bottom surface of the staple, but the coupling shaft 2600 does not extend beyond the bottom surface of the staple. To help facilitate this coupling, as one such example, the coupling member 1107 of the coupling shaft 2600 can extend into the respective handling coupling receptacles of the staple such that the distal end of the coupling member 1107 of the coupling shaft 2600 is received within the body of the staple (e.g., within the respective handling coupling receptacle of the staple). Thus, the coupling member 1107 can extend outward from the distal end 1103 of the coupling shaft 2600 a distance 2604 that is equal to or less than the depth of each handling coupling receptacle of the staple. This can help promote a generally flush contact interface between the bottom surface of the staple and the surface of one or more bones.
[0190] To help promote this type of generally flush contact interface with the staple or other implant, the coupling shaft 2600 may include a collet 2602 at the distal end 1103. The collet 2602 may be attached to the distal end 1103 of the coupling shaft 2600 over a portion (e.g., some but not all) of the coupling member 1107. For example, if the coupling member 1107 is threaded, the collet 2602 may include complementary threads configured to attach to the coupling member 1107. Once the collet 2602 is attached (e.g., threaded) to the coupling member 1107 at the distal end 1103 of the coupling shaft 2600 to define a distance 2604 that the coupling member 1107 extends out from the collet 2602, the collet 2602 may be further attached (e.g., welded, fastened, etc.) to the distal end 1103 of the coupling shaft 2600 at that location.
[0191] Thus, the collet 2602 can be used to help define the extent of the coupling member 1107 from the distal end 1103 of the coupling shaft 2600. In other words, by using a collet 2602 of a selected collet length 2606, the inclusion of the collet 2602 at the distal end 1103 can cover a portion of the extent of the coupling member 1107 (e.g., a length of the coupling member equal to the collet length 2606), such that the remaining exposed portion of the coupling member 1107 extends out from the distal end 1103 of the coupling shaft 2600 a distance 2604 that is equal to or less than the depth of each handling coupling receptacle of the staple. Thus, the distance 2604 that the coupling member 1107 extends out from the collet 2602 can be sufficient to store stresses that occur at the connection between the staple and the coupling shaft when the staple is handled (e.g., when the staple is powered), but short enough so that the coupling member 1107 does not extend out from the bottom surface of the staple when the coupling shaft 2600 is coupled to the staple. For example, during installation, the bottom surface of the collet 2602 can contact the top surface of the implant. As a result, bending forces applied by the inserter can be applied through the interface between the inserter and the implant rather than through the inserter threads.
[0192] 27A-27D illustrate another embodiment of a multi-piece inserter coupling shaft 2700. FIG. 27A is an exploded elevational view of this embodiment of the inserter coupling shaft 2700. FIG. 27B is a close-up elevational view of the distal end 1103 of this embodiment of the inserter coupling shaft 2700. FIG. 27C is an elevational view of this embodiment of the inserter coupling shaft 2700 coupled to an exemplary orthopedic implant, shown here as staple 500. FIG. 27D is a close-up elevational view of the distal end 1103 of this embodiment of the inserter coupling shaft 2700 when coupled to staple 500 as in FIG. 27C. The inserter coupling shaft 2700 can have any one or more features (e.g., each feature) shown and / or described elsewhere herein with respect to embodiments of the inserter coupling shaft, including features or use as part of an inserter embodiment more generally, unless otherwise described herein. As such, like reference characters are used to indicate like elements.
[0193] 27A , the inserter coupling shaft 2700 can include an inner shaft 2701 and an outer shaft 2702. The inner shaft 2701 can be disposed at least partially inside the outer shaft 2702. For example, the inner shaft 2701 can include a coupling member 1107 at a distal end of the inner shaft 2701, and the inner shaft 2701 can be disposed inside the outer shaft 2702 such that the coupling member 1107 of the inner shaft 2701 extends out from the distal end of the outer shaft 2702. The inner shaft 2701 and the outer shaft 2702 can be rotatably attached to one another such that one of the inner shaft 2701 and the outer shaft 2702 is configured to rotate relative to the other of the inner shaft 2701 and the outer shaft 2702. For example, a user can actuate (e.g., rotate) the proximal end 1120 of the inner shaft 2701 to move the outer shaft 2702 in a direction 2704 along the longitudinal axis of the coupling shaft 2700. Thus, in this example, rotating the inner shaft 2701 can move the outer shaft 2702 closer to the staples 500 (thus strengthening the connection between the staples 500 and the coupling shaft 2700, e.g., when powering and / or placing the staples 500 in one or more bones) and / or away from the staples 500 (thus loosening the connection between the staples 500 and the coupling shaft 2700, e.g., to remove the coupling shaft from the staples 500).
[0194] Similar to other coupling shaft embodiments disclosed elsewhere herein, the coupling shaft 2700 can be configured to facilitate a generally flush contact interface with the staple 500 or other implant. As one such example, the coupling shaft 2700 can include a coupling member 1107 that extends from the distal end 1103 of the coupling shaft 2700 a distance 2604 that is equal to or less than the depth of each handling coupling receptacle of the staple 500. Thus, the inner shaft 2701 can be longer than the outer shaft 2702 by at least the distance 2604, such that when the inner shaft 2701 is attached (e.g., rotatably attached) to the outer shaft 2702, the coupling member 1107 of the inner shaft 2701 extends from the outer shaft 2702 by the distance 2604. This configuration of the coupling shaft 2700 with the extent of the coupling member 1107 at the aforementioned distance 2604 can help promote a generally flush contact interface between the bottom surface of the staple 500 and the surface of one or more bones.
[0195] The coupling shaft 2700 can include one or more features that facilitate providing stability during the implant placement process (e.g., powering the implant). As one such example, the coupling shaft 2700 can include a shaft stabilizing arm 2704 to facilitate increased stability when applying a load force to the staple 500. In the illustrated embodiment, the shaft stabilizing arm 2704 is included at the distal end of the outer shaft 2702, while the coupling member 1107 is included at the distal end of the inner shaft 2701, such that when the coupling shaft 2700 is assembled, the shaft stabilizing arm 2704 can be adjacent to the coupling member 1107. When so included, the shaft stabilizing arm 2704 can be located at the distal end 1103 of the coupling shaft 2700 and extend in a direction parallel to the central longitudinal axis of the coupling shaft 2700. When the implant is a staple such as staple 500, the shaft coupling arm 2704 can be configured to contact the bridge 506 of the staple 500 (e.g., contact the upper and / or side surfaces of the bridge, but not the lower surface of the bridge facing the bone(s)) when the coupling member 1107 of the coupling shaft 2700 is in the respective handling coupling of the staple as shown in FIG. 27C.
[0196] 27B and 27D , the illustrated embodiment of the shaft stabilization arm 2704 includes a stabilization arm tab 2706 and a stabilization arm shoulder 2708. The tab 2706 can be offset and radially spaced from the coupling member 1107, and the tab 2706 can extend parallel to the central longitudinal axis of the coupling shaft 2700 (e.g., parallel to the central longitudinal axis of the inner shaft 2701). The tab 2706 can be radially spaced from the coupling member 1107 to facilitate contact of the bridge 506 while the coupling member 1107 is in the handling coupling 508 of the staple 500. More specifically, the tab 2706 can be radially spaced from the coupling member 1107 to facilitate contact of the side surface 506A of the bridge 506 when the coupling member 1107 is in the handling coupling 508 of the staple 500. The side surface 506A can at least partially form a peripheral sidewall of the staple 500 connecting the upper surface 526 of the staple 500 to the lower surface 528 of the staple 500. In this manner, the tab 2706 can function to limit movement of the staple, such as during the staple deployment process, and the tab 2706 can be configured to impede or prevent relative rotation between at least the outer shaft 2702 and the staple 500. Similarly, the shoulder 2708 can also be offset and radially spaced from the coupling member 1107. The shoulder 2708 can extend generally perpendicular to the central longitudinal axis of the coupling shaft 2700 (e.g., perpendicular to the central longitudinal axis of the inner shaft 2701). The shoulder 2708 can be radially spaced from the coupling member 1107 to facilitate contact of the bridge 506 when the coupling member 1107 is in the handling coupling 508 of the staple 500.However, the tab 2706 can be configured to contact the side surface 506A of the bridge 506 while the coupling member 1107 is in the handling coupling 508 of the staple 500, while the shoulder 2708 can be configured to contact the top surface 526 of the bridge 506 while the coupling member 1107 is in the handling coupling 508 of the staple 500.
[0197] 27A-27D, the coupling shaft 2700 can include a second tab 2707. The second tab 2707 is disposed on the outer shaft 2702 and is radially spaced apart from the coupling member 1107, e.g., radially spaced apart from the coupling member 1107 on a different side of the coupling member 1107 than the tab 2706. Similar to the tab 2706, the second tab 2707 can be configured to contact the side 506A of the bridge 506, except that the second tab 2707 can be configured to contact the side 506A of the bridge 506 opposite the tab 2706. The second tab 2707 can be configured to inhibit or prevent relative rotation between at least the outer shaft 2702 and the staple 500, including working in conjunction with the tab 2706 such that the tab 2706 and the second tab 2707 are configured to inhibit an opposing direction of relative rotation between at least the outer shaft 2702 and the staple 500.
[0198] In particular, the disclosed configuration of the coupling shaft 2700 can avoid obstructing the bottom surface 528 of the staple 500, allowing the bottom surface 528 of the staple 500 to reside generally flush with one or more bone surfaces without the coupling shaft 2700 extending beyond the bottom surface 528 of the staple 500. At the same time, the coupling shaft 2700 can include one or more features, such as shaft stabilizing arms 2704, that facilitate providing stability during placement, power application, and / or insertion of the staple 500 during application of one or more forces to the staple 500 (e.g., during application of a load force to the staple 500).
[0199] As discussed above, the coupling shaft 2700 can be configured to couple to the staple 500 through the top surface 526 of the staple 500. The coupling shaft 2700 can be configured to couple to the first handling coupling 508 and / or the second handling coupling 510 through the top surface 526 of the staple 500, for example, without extending below the bottom surface 528 of the staple 500. In one exemplary application in which the staple 500 is placed in a metatarsal, cuneiform bone, and bridges a space between the metatarsal and cuneiform bone (e.g., a joint space such as the TMT joint space), when the coupling shaft 2700 is connected to the first handling coupling 508 and / or the second handling coupling 510 via the upper surface 526 without extending below the bottom surface 528 of the staple 500, the bottom surface 528 of the staple 500 can be configured to directly contact at least one of the metatarsal and cuneiform bone without any inserter structure, including any structure of the coupling shaft 2700, between the bottom surface 528 and at least one of the metatarsal and cuneiform bone. This configuration may allow the bottom surface 528 of the staple 500 to be positioned more flush against the metatarsal and / or cuneiform bone when the coupling shaft 2700 is coupled to the staple 500, compared to a configuration in which the inserter structure, including the structure of the coupling shaft 2700, resides between the bottom surface 528 and the metatarsal and / or cuneiform bone.
[0200] In some examples in which the coupling shaft 2700 is configured to couple to the staple 500 via the upper surface 526 of the staple 500 and includes one or more shaft stabilizing arm(s) 2704, the coupling shaft 2700 can be further configured to couple to the first handling coupling 508 and / or the second handling coupling 510 via the upper surface 526 of the staple 500 without the one or more shaft stabilizing arm(s) 2704 extending downwardly across the entire thickness 550 of the peripheral side wall (e.g., side wall 506A) of the staple 500, connecting the upper surface 526 of the staple 500 to the lower surface 528 of the staple 500. For example, the bridge 506 can define a thickness 550 of the bridge 506, and the coupling shaft 2700 can be further configured to couple to the first handling coupling 508 and / or the second handling coupling 510 through the upper surface 526 of the staple 500 without the one or more shaft stabilizing arm(s) 2704 extending downwardly across the entire thickness 550 of the bridge 506. In an alternative example where the coupling shaft 2700 is configured to couple to the staple 500 through the upper surface 526 of the staple 500, the coupling shaft 2700 can be further configured to couple to the first handling coupling 508 and / or the second handling coupling 510 through the upper surface 526 of the staple 500 without the shaft stabilizing arm(s) 2704 extending downwardly across more than three-quarters of a peripheral side wall (e.g., side wall 506A) of the staple 500, connecting the upper surface 526 of the staple 500 to the lower surface 528 of the staple 500. For example, the coupling shaft 2700 can be further configured such that one or more shaft stabilizing arms 2704 connect to the first handling coupling 508 and / or the second handling coupling 510 through the upper surface 526 of the staple 500 without extending downward more than three-quarters of the thickness 550 of the bridge 506.In another alternative example where the coupling shaft 2700 is configured to couple to the staples 500 through the upper surface 526 of the staples 500, the coupling shaft 2700 can be further configured to couple to the first handling coupling 508 and / or the second handling coupling 510 through the upper surface 526 of the staples 500 without the shaft stabilizing arm(s) 2704 extending downwardly more than halfway through the peripheral side wall (e.g., side wall 506A) of the staples 500, connecting the upper surface 526 of the staples 500 to the lower surface 528 of the staples 500. For example, the coupling shaft 2700 can be further configured to couple to the first handling coupling 508 and / or the second handling coupling 510 through the upper surface 526 of the staples 500 without the one or more shaft stabilizing arm(s) 2704 extending downwardly more than halfway through the thickness 550 of the bridge 506. In these noted examples, the thickness 550 of the peripheral sidewall (e.g., sidewall 506A) of the staple 500 and / or the thickness 550 of the bridge 506 connecting the upper surface 526 of the staple 500 and the lower surface 528 of the staple 500 can be at least 0.5 mm. Thus, in examples in which the coupling shaft 2700 is configured to couple to the first handling coupling 508 and / or the second handling coupling 510 without the shaft stabilizing arm(s) 2704 extending down more than three-quarters of the peripheral sidewall (e.g., sidewall 506A) of the staple 500, the coupling shaft 2700 can be configured to so couple without the shaft stabilizing arm(s) 2704 extending down more than three-quarters of the at least 0.5 mm thickness 550 of the peripheral sidewall (e.g., sidewall 506A) of the staple 500.Also, in examples in which the coupling shaft 2700 is configured to couple to the first handling coupling 508 and / or the second handling coupling 510 without the stabilizing arm(s) 2704 extending downwardly more than halfway through the peripheral side wall (e.g., side wall 506A) of the staple 500, the coupling shaft 2700 can be configured to so couple without the shaft stabilizing arm(s) 2704 extending downwardly more than halfway through a thickness 550 of at least 0.5 mm of the peripheral side wall (e.g., side wall 506A) of the staple 500.
[0201] 27D , the coupling shaft 2700 can be configured to couple to the staples 500 via the top surfaces 526 of the staples 500, such that only the staples 500, and not any portion of the inserter (e.g., any portion of the coupling shaft 2700), define a contact interface with the one or more bones into which the staples 500 are inserted. This coupling configuration of the staples 500 and the coupling shaft 2700, such that only the staples contact the one or more bones into which the staples 500 are inserted, can facilitate flush insertion of the staples 500 into the one or more bones because no structure on the inserter (e.g., the coupling shaft 2700) is in a position to contact the one or more bones that would prevent the staples 500 from being inserted flush into the one or more bones. As an example, the inserter (e.g., the coupling shaft 2700) can be configured to couple to the staples 500 by contacting the staples 500 only at a location above the bottom surface 528 of the staples 500. As best shown in FIG. 27D , in the illustrated embodiment of the coupling shaft 2700, the coupling shaft 2700 is configured to contact the staples 500 only at a location above the bottom surface 528 of the staples 500. As shown in this embodiment illustrated in FIGS. 27B and 27D , when the coupling shaft 2700 is coupled to the staples 500, the implant coupling member 1107 and the shaft stabilizing arms 2704 (e.g., including the stabilizing arm tabs 2706) contact the staples 500 only at a portion of the staple above the bottom surface 528 of the staples 500. For example, the implant coupling member 1107 contacts the staple 500 at the handling coupling 508 of the staple 500 only at a position on the handling coupling 508 above the bottom surface 528 of the staple 500, and the shaft stabilizing arm 2704 (e.g., including the stabilizing arm tab 2706) contacts the staple 500 at the side wall 506a of the staple 500 only at a position on the side wall 506a above the bottom surface 528 of the staple 500.
[0202] In embodiments in which the coupling shaft 2700 includes one or more shaft stabilizing arm(s) 2704, the one or more shaft stabilizing arm(s) 2704 can contact the staple 500 only along a single plane. For example, as shown in the illustrated example in FIG. 27D , the side wall 506 a of the staple 500 can define one plane, and the shaft stabilizing arm 2704 can contact the side wall 506 a of the staple 500 only in that one plane defined by the side wall 506 a of the staple 500. In such an example, the side wall 506 a of the staple 500 can define a planar staple contacting surface, the shaft stabilizing arm 2704 can define a planar arm contacting surface at the tab 2706, and the planar staple contacting surface at the side wall 506 a and the planar arm contacting surface at the tab 2706 can define the shaft stabilizing arm 2704 to contact the staple 500 only along a single plane. For example, in certain embodiments, the only contact between the staple 500 and the coupling shaft 2700, both (i) below the top surface 526 of the staple 500 and (ii) around the periphery of the staple 500, can be contact between the coupling shaft 2700 and the staple 500 in a single plane.
[0203] 28A-28C illustrate another embodiment of an orthopedic implant in the form of a staple 2800. In particular, FIG. 28A is a longitudinal side view of staple 2800, FIG. 28B is a radial side view of staple 2800, and FIG. 28C is a top plan view of staple 2800.
[0204] Aspects of staple 2800 can be similar to or the same as staple 500 disclosed elsewhere herein, unless specifically noted otherwise. For example, staple 2800 can include one or more (e.g., each) of the features disclosed herein with respect to staple 500, unless otherwise noted. An exemplary deflected, compression-induced state of staple 2800 is shown in Figures 28A-28C. Additionally, staple 2800 can be configured to transition between the deflected, compression-induced state and the deformed, inserted state, as disclosed elsewhere herein (e.g., with respect to staple 500).
[0205] The staple 2800 can include a body 2801 including a first side 2803 and a second side 2805 opposite the first side 2803. A bridge 2807 of the body 2801 extends between the first side 2803 and the second side 2805. The staple 2800 includes a first leg 2802, a second leg 2804, a third leg 2806, and a fourth leg 2808 on the body 2801. The staple 2800 includes the first leg 2802 and the second leg 2804 on the first side 2803 of the bridge 2807 and the third leg 2806 and the fourth leg 2808 on the second side 2805 of the bridge 2807. The staple 2800 can be symmetrical about the bridge 2807. 28A , the staple 2800 can include a curvature along the body 2801 on the first side 2803 of the bridge 2807, resulting in one or more height changes along the body 2801 on the first side 2803 that are symmetrical with the curvature along the body 2801 on the second side 2805 of the bridge 2807, resulting in one or more height changes along the body 2801 on the second side 2805 that are symmetrical with the one or more height changes on the first side 2803. As another additional or alternative example of the symmetry defined by the staple 2800, the configuration of the first leg 2802 and the second leg 2804 on the first side 2803 of the staple 2800 can be symmetrical with the configuration of the third leg 2806 and the fourth leg 2808 on the second side 2805 of the staple 2800. As a further additional or alternative example of the symmetry defined by staple 2800, staple 2800 can be symmetrical about a radial plane extending perpendicular to a central longitudinal axis 2809 of bridge 2807 through the center of bridge 2807, thereby bisecting staple 2800 at the center of bridge 2807, with one bisected half including first side 2803 and the other bisected half including second side 2805, such that one bisected half including first side 2803 is symmetrical to the other bisected half including second side 2805.
[0206] The symmetrical nature of the configuration of the first end 283 and the second end 2805 of the staple 2800 can be useful in helping to reduce the size of the access incision required to implant the staple 2800. The symmetrical nature of the configuration of the staple 2800 can also be useful in allowing two identical staples 2800 to be used in two different locations along one or more bone sections, thereby reducing inventory costs.
[0207] As shown in the illustrated embodiment, the staple 2800 can include an offset leg arrangement of a first leg 2802 and a second leg 2804 on a first side 2803 and an offset leg arrangement of a third leg 2806 and a fourth leg 2808 on a second side 2805. As seen in FIG. 28B , the first leg 2802 can be offset from the second leg 2804 relative to a central longitudinal axis 2809 of the bridge 2807. For example, the second leg 2804 can be aligned with the central longitudinal axis 2809 of the bridge 2807, while the first leg 2802 can be offset from the central longitudinal axis 2809 of the bridge 2807. Additionally, this second leg 2804, which is aligned with the central longitudinal axis 2809, can be closer to the bridge 2807 than the first leg 2802, which is offset from the central longitudinal axis 2809. Similarly, the third leg 2806 and the fourth leg 2808 can have the same or similar offset configuration relative to the central longitudinal axis 2809 as the first leg 2802 and the second leg 2804. That is, in this example, the fourth leg 2808 can be aligned with the central longitudinal axis 2809 of the bridge 2807, while the third leg 2806 can be offset from the central longitudinal axis 2809 of the bridge 2807. Also, this fourth leg 2808, which is aligned with the central longitudinal axis 2809, can be closer to the bridge 2807 than the third leg 2806, which is offset from the central longitudinal axis 2809. The staple 2800 can include two or more legs 2802, 2804, 2806, 2808 extending in parallel directions relative to one another. For example, the first leg 2802 and the second leg 2804 extend parallel to one another, and the third leg 2806 and the fourth leg extend parallel to one another. The illustrated embodiment shows the relatively parallel orientation of the first leg 2802 and the second leg 2804 and the relatively parallel orientation of the third leg 2806 and the fourth leg 2808 when the staple 2800 is in the biased compression-inducing state. In particular, the first leg 2802 can define a first leg central longitudinal axis 2832, the second leg 2804 can define a second leg central longitudinal axis 2834, and the first leg central longitudinal axis 2832 can be parallel to the second leg central longitudinal axis 2834. Similarly, the third leg 2806 can define a third leg central longitudinal axis 2836, the fourth leg 2808 can define a fourth leg central longitudinal axis 2838 (e.g., when the staple 2800 is in a deflected compression-induced state), and the third leg central longitudinal axis 2836 can be parallel to the fourth leg central longitudinal axis 2838 (e.g., when the staple 2800 is in a deflected compression-induced state). In yet another example, the angle at which the first leg 2802 extends can be opposite the angle at which the third leg 2806 extends, and the angle at which the second leg 2804 extends can be opposite the angle at which the fourth leg 2808 extends. The first leg 2802 can have a first leg length in a direction extending along the first leg central longitudinal axis 2832, and the second leg 2804 can have a second leg length in a direction extending along the second leg longitudinal axis 2834, where the first leg length is different from the second leg length (e.g., shorter, as shown in the illustrated embodiment). Similarly, the third leg 2806 can have a third leg length in a direction extending along the third leg longitudinal axis 2836, and the fourth leg 2808 can have a fourth leg length in a direction extending along the fourth leg longitudinal axis 2836, where the third leg length is different from the fourth leg length (e.g., shorter, as shown in the illustrated embodiment). Thus, the outer legs (first leg 2802 and third leg 2806) can have shorter leg lengths than the inner legs (second leg 2804 and fourth leg 2808).
[0208] The staple 2800 may also include one or more handling couplings 2850, 2852. As shown in the illustrated embodiment, the staple 2800 includes a first handling coupling 2850 on a first side 2803 and a second handling coupling 2852 on a second side 2805. The first handling coupling 2850 can be disposed between the first leg 2802 and the second leg 2804, and the second handling coupling 2852 can be disposed between the third leg 2806 and the fourth leg 2808. In the illustrated embodiment, the handling couplings 2850, 2852 extend through the entire thickness of the body 2801, with each handling coupling 2850, 2852 opening on each of the upper and lower sides of the body 2801. However, in other embodiments, one or both of the handling couplings 2850, 2852 may extend only partially through the thickness of the body 2801 (e.g., open only to the top side of the body 2801). As disclosed elsewhere herein, each of the handling couplings 2850, 2852 can be configured to receive and couple to a coupling shaft, for example, to facilitate powering the staples 2800 (e.g., transitioning the staples 2800 from a deflected compression-inducing state to a deformed insertion state). As one such example, as disclosed elsewhere herein, each handling coupling 2850, 2852 can include a complementary connection feature (e.g., threads) with a corresponding connection feature (e.g., complementary threads) on the respective coupling shaft to facilitate connection between the respective handling coupling and the coupling shaft.
[0209] In some examples, in the deflected compression-induced state of staple 2800 shown in FIGS. 28A-28C, bridge 2807 can arch upwardly away from legs 2802, 2804, 2806, 2808 such that in embodiments in which legs 2802, 2804, 2806, 2808 are equal in length, the ends of the legs opposite bridge 2807 can be at two or more different heights. For example, when the staple 2800 is in a deflected compression-induced state, the first leg 2802 and the third leg 2806 (e.g., the outermost legs) terminate at a first equal height, and the second leg 2804 and the fourth leg 2808 (e.g., the innermost legs) terminate at a second equal height that is different from the first height (e.g., the second leg 2804 and the fourth leg 2808 terminate radially farther from the bridge 2807 than the first leg 2802 and the third leg 2806).
[0210] As disclosed elsewhere herein, the bridge 2807 can have a length sufficient to position the bridge across a space (e.g., a joint) between bone portions of the foot (e.g., two different bones) while maintaining the first leg 2802 and the second leg 2804 on one such bone portion and the third leg 2806 and the fourth leg 2808 on the other such bone portion.
[0211] The staples described herein can be used alone or in combination with one or more other bone fixation devices to secure and fuse joints between opposing bone portions. Other types of bone fixation devices that can be used include, but are not limited to, bone screws (e.g., compression bone screws), bone plates, external fixation devices, pins (e.g., intramedullary implants), and / or combinations thereof. Staples according to the present disclosure can be installed before or after the placement of one or more other bone fixation devices (if used) into the bone portions to be secured.
[0212] Various examples have been described. These and other examples are within the scope of the following claims.
Claims
1. 1. A system comprising: a staple comprising: a first leg on a first side of the staple; a second leg on a second side of the staple; a bridge connecting the first leg and the second leg; a first handling coupling passing through a top surface of the staple on the first side of the staple; and a second handling coupling passing through the top surface of the staple on the second side of the staple, the staple including a bottom surface configured to face one or more bones, the top surface of the staple being opposite the bottom surface of the staple; and an inserter configured to be coupled to the first handling coupling through the top surface of the staple without extending below the bottom surface of the staple, and to be coupled to the second handling coupling through the top surface of the staple without extending below the bottom surface of the staple, When the inserter is connected to the first handling coupling and the second handling coupling, the inserter is configured to apply a load force to the staple to move the first leg and the second leg away from each other.
2. 2. The system of claim 1, wherein the inserter is further configured to connect to the first side of the staple through the top surface of the first side of the staple without extending below the bottom surface of the first side of the staple or contacting the periphery of the first side of the staple, and the inserter is further configured to connect to the second side of the staple through the top surface of the second side of the staple without extending below the bottom surface of the second side of the staple or contacting the periphery of the second side of the staple.
3. 3. The system of claim 1, wherein the inserter is further configured to connect to the first side of the staple through the top surface of the first side of the staple without extending below the bottom surface of the first side of the staple, and wherein when the inserter is connected to the first handling coupling, the bottom surface of the staple is configured to directly contact the one or more bones without any inserter structure between the bottom surface of the staple and the one or more bones.
4. 4. The system of claim 3, wherein the inserter is further configured to connect to the second side of the staple through the top surface of the second side of the staple without extending below the bottom surface of the second side of the staple, and wherein when the inserter is connected to the second handling coupling, the bottom surface of the staple is configured to directly contact the one or more bones without any inserter structure between the bottom surface of the staple and the one or more bones.
5. 5. The system of claim 1, wherein the staple and the inserter are further configured such that when the inserter is coupled to the first handling coupling, the inserter contacts the first handling coupling and the inserter is isolated at the first handling coupling from contacting any peripheral sidewalls of the staple that connect the top surface of the staple to the bottom surface of the staple, and wherein the staple and the inserter are further configured such that when the inserter is coupled to the second handling coupling, the inserter contacts the second handling coupling and the inserter is isolated at the second handling coupling from contacting any peripheral sidewalls of the staple.
6. 6. The system of claim 1, wherein the inserter is further configured to couple to the first handling coupling through the top surface of the staple without extending down the entire thickness of a peripheral sidewall of the staple connecting the top surface of the staple to the bottom surface of the staple, and wherein the inserter is further configured to couple to the second handling coupling through the top surface of the staple without extending down the entire thickness of the peripheral sidewall of the staple connecting the top surface of the staple to the bottom surface of the staple.
7. 7. The system of claim 1, wherein the inserter is further configured to couple to the first handling coupling through the top surface of the staple without extending down more than three-quarters of a peripheral sidewall of the staple connecting the top surface of the staple to a bottom surface of the staple, and wherein the inserter is further configured to couple to the second handling coupling through the top surface of the staple without extending down more than three-quarters of a peripheral sidewall of the staple connecting the top surface of the staple to the bottom surface of the staple.
8. 8. The system of claim 1, wherein the inserter is further configured to couple to the first handling coupling through the top surface of the staple without extending down more than halfway of the staple's peripheral sidewall connecting the top surface of the staple to the bottom surface of the staple, and wherein the inserter is further configured to couple to the second handling coupling through the top surface of the staple without extending down more than halfway of the staple's peripheral sidewall connecting the top surface of the staple to the bottom surface of the staple.
9. 9. The system of claim 1, wherein the inserter is configured such that when the inserter is detached from at least one of the first handling coupling and the second handling coupling, the loading force is removed from the staple and the first leg and the second leg move toward each other to apply a compressive force.
10. 10. The system of claim 9, wherein the inserter comprises: a first coupling shaft configured to connect to the first handling coupling through the top surface of the staple without extending below the bottom surface of the staple; and a second coupling shaft configured to connect to the second handling coupling through the top surface of the staple without extending below the bottom surface of the staple.
11. 11. The system of claim 9, wherein the inserter is configured to apply the load force when the first coupling shaft and the second coupling shaft are deflected toward each other.
12. 12. The system of any one of claims 9 to 11, wherein when the first coupling shaft is connected to the first handling coupling and the second coupling shaft is connected to the second handling coupling, the first coupling shaft and the second coupling shaft are configured to move toward each other to apply the loading force to the staple, and the first coupling shaft and the second coupling shaft are configured to move away from each other to move the first leg of the staple and the second leg of the staple toward each other.
13. the first handling coupling includes a first handling coupling receptacle extending from the top surface of the staple toward the bottom surface of the staple; 13. The system of any one of claims 9 to 12, wherein the second handling coupling comprises a second handling coupling receptacle extending from the top surface of the staple toward the bottom surface of the staple.
14. 14. The system of claim 13, wherein the first handling coupling receptacle and the second handling coupling receptacle are each threaded, the first coupling shaft defining a first coupling shaft threaded end that engages with the threaded first handling coupling receptacle, and the second coupling shaft defining a second coupling shaft threaded end that engages with the threaded second handling coupling receptacle.
15. 15. The system of any one of claims 11 to 14, further comprising a connector configured to couple the first coupling shaft and the second coupling shaft, wherein the first coupling shaft is connected to the first handling coupling and the second coupling shaft is connected to the second handling coupling, and the first coupling shaft and the second coupling shaft are configured to apply the load force to the staple when the connector couples the first coupling shaft and the second coupling shaft.
16. 16. The system of claim 15, wherein the connector comprises a first receptacle and a second receptacle, the first receptacle being spaced from the second receptacle by a distance such that when the first coupling shaft is in the first receptacle and the second coupling shaft is in the second receptacle, the first leg and the second leg extend parallel to each other.
17. 17. The system of claim 15 or 16, wherein the connector comprises a first receptacle and a second receptacle, the first coupling shaft including a first retention feature and the second coupling shaft including a second retention feature, the first retention feature configured to retain the first coupling shaft in the first receptacle and the second retention feature configured to retain the second coupling shaft in the second receptacle.
18. 18. The system of claim 15, wherein the connector comprises a cap configured to be disposed over an end of the first coupling shaft and an end of the second coupling shaft.
19. 19. The system of any one of claims 1 to 18, wherein the bottom surface of the staple configured to face one or more bones includes the bottom surface of the staple configured to face a first bone, a second bone, and a space between the first bone and the second bone.
20. 20. The system of any one of claims 1-19, wherein the bridge of the staples is configured to span the space between the first bone and the second bone.
21. 21. The system of any one of claims 1 to 20, wherein at least one of the first bone and the second bone is a metatarsal.
22. 22. The system of any one of claims 1 to 21, wherein the first bone is a metatarsal and the second bone is a cuneiform bone, the space between the first bone and the second bone is a tarsometatarsal joint space separating the metatarsal from the cuneiform bone, and the bridge of the staple is configured to be positioned across the tarsometatarsal joint space.
23. 23. The system of claim 22, wherein the staple is configured such that when the first leg is placed on the metatarsal and the second leg is placed on the cuneiform, the bridge of the staple is spaced across the tarsometatarsal joint space.
24. The inserter is configured to connect to the first side of the staple through the top surface of the first side of the staple without extending below the bottom surface of the first side of the staple, and when the inserter is connected to the first handling coupling, the bottom surface of the staple is configured to directly contact the at least one of the metatarsal and the cuneiform bone without any inserter structure between the bottom surface of the staple and the at least one of the metatarsal and the cuneiform bone, and the inserter is configured to connect to the staple through the top surface of the first side of the staple without extending below the bottom surface of the first side of the staple, and when the inserter is connected to the first handling coupling, the bottom surface of the staple is configured to directly contact the at least one of the metatarsal and the cuneiform bone without any inserter structure between the bottom surface of the staple and the at least one of the metatarsal and the cuneiform bone, and 24. The system of claim 22 or 23, further configured to connect to the second side of the staple through the top surface of the second side of the staple without extending below the bottom surface of the second side of the staple, wherein when the inserter is connected to the second handling coupling, the bottom surface of the staple is configured to directly contact the at least one of the metatarsal and the cuneiform bone without any inserter structure between the bottom surface of the staple and the at least one of the metatarsal and the cuneiform bone.
25. 1. A system comprising: a staple comprising: a first leg on a first side of the staple; a second leg on the first side of the staple; a third leg on a second side of the staple; a fourth leg on the second side of the staple; bridges connecting the first and second legs to the third and fourth legs; a first handling coupling on the first side of the staple; and a second handling coupling on the second side of the staple; a first coupling shaft configured to couple to the first handling coupling, a second coupling shaft configured to couple to the second handling coupling, and a connector configured to join the first coupling shaft and the second coupling shaft; the staple is configured such that the first leg and the second leg move toward the third leg and the fourth leg when the connector is detached from at least one of the first coupling shaft and the second coupling shaft.
26. 26. The system of claim 25, wherein the second leg and the fourth leg are aligned with a central longitudinal axis of the bridge, and the first leg and the third leg are offset from the central longitudinal axis of the bridge.
27. 27. The system of claim 25 or 26, wherein the first leg is offset from the central longitudinal axis of the bridge in the same direction as the third leg is offset from the central longitudinal axis of the bridge.
28. 28. The system of any one of claims 25 to 27, wherein the staples are symmetrical about the central longitudinal axis of the bridge.
29. 29. The system of claim 28, wherein a radial plane extends perpendicular to the central longitudinal axis of the bridge and through a center of the bridge, bisects the staple at the center of the bridge, one bisect half of the staple comprises the first side and the other bisect half of the staple comprises the second side, the staples are symmetrical about the radial plane, and the one bisect half of the staple is symmetrical to the other bisect half of the staple.
30. 30. The system of any one of claims 25 to 29, wherein the first handling coupling is disposed between the first leg and the second leg, and the second handling coupling is disposed between the third leg and the fourth leg.
31. 31. The system of any one of claims 25 to 30, wherein when the connector is detached from at least one of the first coupling shaft and the second coupling shaft, the staple is configured such that the first leg and the second leg extend parallel to each other and the third leg and the fourth leg extend parallel to each other.
32. A staple, a first leg and a second leg on a first side of the staple; a third leg and a fourth leg on a second side of the staple; a bridge connecting the first leg and the second leg to the third leg and the fourth leg; a first handling coupling that penetrates a top surface of the staple on the first side of the staple, the staple being configured so that the top surface of the staple faces away from a bone when the staple is implanted, the first handling coupling being configured to receive a first coupling shaft on the top surface of the first side of the staple; and The staple, comprising: a second handling coupling that penetrates the top surface of the staple on the second side of the staple, the second handling coupling configured to receive a second coupling shaft on the top surface of the second side of the staple.
33. 33. The staple of claim 32, wherein the first handling coupling and the second handling coupling are each threaded, the first handling coupling configured to receive the first coupling shaft through the top surface of the first side of the staple to engage with the threads of the first handling coupling, and the second handling coupling configured to receive the second coupling shaft through the top surface of the second side of the staple to engage with the threads of the second handling coupling.
34. 34. The staple of claim 32 or 33, wherein the first handling coupling is disposed between the first leg and the second leg, and the second handling coupling is disposed between the third leg and the fourth leg.
35. 35. The staple of any one of claims 32 to 34, wherein the first leg has a first leg length in a direction extending along a longitudinal axis of the first leg, the second leg has a second leg length in a direction extending along a longitudinal axis of the second leg, the first leg length being different from the second leg length, the third leg has a third leg length in a direction extending along the longitudinal axis of the third leg, and the fourth leg has a fourth leg length in a direction extending along the longitudinal axis of the fourth leg, the third leg length being different from the fourth leg length.
36. 36. The staple of any one of claims 32 to 35, wherein the second leg is positioned closer to the third leg than the first leg, the second leg having a longer length than the first leg, the fourth leg is positioned closer to the first leg than the third leg, and the fourth leg has a longer length than the third leg.
37. 37. The staple of any one of claims 32 to 36, wherein the second leg and the fourth leg are aligned with a central longitudinal axis of the bridge, and the first leg and the third leg are offset from the central longitudinal axis of the bridge.
38. 38. The staple of any one of claims 32 to 37, wherein the first leg is offset from the central longitudinal axis of the bridge in the same direction as the third leg is offset from the central longitudinal axis of the bridge.
39. 39. The staple of any one of claims 32 to 38, wherein the staple is symmetrical about the central longitudinal axis of the bridge.
40. 40. The staple of any one of claims 32 to 39, wherein a radial plane extends perpendicular to the central longitudinal axis of the bridge and through a center of the bridge, bisecting the staple at the center of the bridge, one bisected half of the staple comprising the first side and the other bisected half of the staple comprising the second side, the staple being symmetrical with respect to the radial plane, and the one bisected half of the staple being symmetrical with respect to the other bisected half of the staple.
41. 41. The staple of any one of claims 32 to 40, wherein the staple defines a first lateral height variation along the top surface of the first side such that a free end of the first leg is at a different height than a free end of the second leg, and wherein the staple defines a second lateral height variation along the top surface of the second side such that a free end of the third leg is at a different height than a free end of the fourth leg.
42. 42. The staple of any one of claims 32 to 41, wherein the staple is configured such that when the first leg and the second leg are positioned on one of the metatarsal and cuneiform bones and the third leg and the fourth leg are positioned on the other of the metatarsal and cuneiform bones, the bridge is configured to span a joint space between the metatarsal and the cuneiform bones.
43. 43. The staple of any one of claims 32 to 42, wherein the first leg includes a first set of teeth extending partially around a circumference of the first leg, the second leg includes a second set of teeth extending partially around a circumference of the second leg, the third leg includes a third set of teeth extending partially around a circumference of the third leg, and the fourth leg includes a fourth set of teeth extending partially around a circumference of the fourth leg.
44. 44. The staple of claim 43, wherein the first set of teeth extends around a portion of the circumference of the first leg facing the third and fourth legs, the second set of teeth extends around a portion of the circumference of the second leg facing the third and fourth legs, the third set of teeth extends around a portion of the circumference of the third leg facing the first and second legs, and the fourth set of teeth extends around a portion of the circumference of the fourth leg facing the first and second legs.
45. The staple of any one of claims 32 to 44, wherein the staple comprises titanium.
46. 1. A system comprising: a staple comprising: a first leg on a first side of the staple; a second leg on a second side of the staple; a bridge connecting the first leg and the second leg; a first handling coupling on the first side of the staple; and a second handling coupling on the second side of the staple; an inserter comprising: a first coupling shaft configured to couple to the first handling coupling; a second coupling shaft configured to couple to the second handling coupling; and a connector configured to couple the first coupling shaft and the second coupling shaft, the connector comprising a first wire-receiving opening configured to receive a first wire and a second wire-receiving opening configured to receive a second wire; when the connector is coupled to the first coupling shaft and the second coupling shaft, the connector is configured to bias the first coupling shaft and the second coupling shaft toward each other to apply a load force to the staple; the staple is configured such that the first leg and the second leg move toward each other when the connector is detached from at least one of the first coupling shaft and the second coupling shaft.
47. 47. The system of claim 46, wherein the first handling coupling comprises a first handling coupling receptacle extending from a top surface of the staple toward a bottom surface of the staple, the second handling coupling comprises a second handling coupling receptacle extending from the top surface of the staple toward the bottom surface of the staple, the first coupling shaft configured to couple to the first handling coupling receptacle at a position between the top surface of the staple and the bottom surface of the staple, and the second coupling shaft configured to couple to the second handling coupling receptacle at a position between the top surface of the staple and the bottom surface of the staple.
48. 48. The system of claim 46 or 47, wherein the first leg defines a first leg central longitudinal axis, the first handling coupling receptacle defines a first handling coupling receptacle central longitudinal axis, and the first leg central longitudinal axis is offset from the first handling coupling receptacle central longitudinal axis.
49. 49. The system of claim 48, wherein a central longitudinal axis of the first leg is closer to the bridge than a central longitudinal axis of the first handling coupling receptacle.
50. 50. The system of any one of claims 46 to 49, wherein the first leg, the second leg, and the bridge comprise titanium.
51. 51. The system of any one of claims 46 to 50, wherein the leg length of each of the first leg and the second leg is in the range of 13 mm to 25 mm.
52. 52. The system of any one of claims 46 to 51, wherein the width of each of the first leg and the second leg is in the range of 2 mm to 3 mm.
53. 53. The system of any one of claims 46 to 52, wherein the bridge length of the bridge is in the range of 15 mm to 20 mm.
54. 54. The system of any one of claims 46 to 53, wherein the first leg includes a first set of teeth extending partially around a circumference of the first leg and the second leg includes a second set of teeth extending partially around a circumference of the second leg.
55. 55. The system of claim 54, wherein the first set of teeth extends around a portion of the circumference of the first leg facing the bridge and the second set of teeth extends around a portion of the circumference of the second leg facing the bridge.
56. The staple is a first locking opening on the first side of the staple; and 56. The system of any one of claims 46 to 55, further comprising a second locking opening on the second side of the staple.
57. 57. The system of claim 56, wherein the first fixed opening is closer to the bridge than the first leg and the second fixed opening is closer to the bridge than the second leg.
58. 58. The system of claim 56 or 57, wherein the first leg is closer to the bridge than the first fixed opening and the second leg is closer to the bridge than the second fixed opening.
59. 59. The system of any one of claims 46 to 58, further comprising a guide defining a body, a first wire opening in the body configured to receive a first wire therethrough, and a second wire opening in the body configured to receive a second wire therethrough, the body having a body length and a body width.
60. 60. The system of claim 59, wherein the guide is a drill guide, the drill guide further comprising a first drill guide opening in the body configured to receive a drill therethrough, and a second drill guide opening in the body configured to receive a drill therethrough.
61. 61. The system of claim 59 or 60, wherein the first and second drill guide openings are located at opposite ends of a length of the body, and the first and second wire openings are located closer to each other along the length of the body than the first and second drill guides.
62. 62. The system of any one of claims 59 to 61, wherein the drill guide further comprises a seeker receiving opening in the body configured to receive a seeker, the seeker receiving opening disposed in the body along a length of the body between the first wire opening and the second wire opening and between the first drill guide opening and the second drill guide opening along a length of the body.
63. 63. The system of any one of claims 59 to 62, further comprising: a seeker comprising a first portion configured to be positioned within a space separating a first bone and a second bone, and a second portion configured to extend out of the space separating the first bone and the second bone, wherein the seeker receiving opening in the body is configured to receive the second portion.
64. 1. A method for fixating and fusing bones, said method comprising: placing a first leg of a staple connected to an inserter into a first implant hole in a first bone and a second leg of the staple connected to the inserter into a second implant hole in a second bone, wherein the first leg of the staple is connected to the second leg of the staple by a bridge, the staples are positioned such that a bottom surface of the staple faces the first bone and the second bone and a top surface of the staple faces away from the first bone and the second bone, and the inserter is connected to the staple through the top surface of the staple without extending below the bottom surface of the staple; disengaging the inserter from the staple.
65. 65. The method of claim 64, further comprising, prior to placing the first leg of the staple in the first implant hole and the second leg of the staple in the second implant hole, (i) connecting the inserter to a first side of the staple having the first leg through the top surface of the first side of the staple without extending below the bottom surface of the first side of the staple, and (ii) connecting the inserter to a second side of the staple having the second leg through the top surface of the second side of the staple without extending below the bottom surface of the second side of the staple.
66. 66. The method of claim 65, wherein the inserter is connected to the first side of the staple through the top surface of the first side of the staple without extending below the bottom surface of the first side of the staple or contacting the periphery of the first side of the staple, and wherein the inserter is connected to the second side of the staple through the top surface of the second side of the staple without extending below the bottom surface of the second side of the staple or contacting the periphery of the second side of the staple.
67. 65. The method of claim 64, further comprising applying a load force to the staple using the inserter, wherein the first leg and the second leg move away from each other when a load force is applied to the staple using the inserter.
68. 68. The method of claim 67, further comprising: (i) removing the load force from the staple after placing the first leg in the first implant hole and the second leg in the second implant hole, and (ii) before removing the inserter from the staple.
69. 69. The method of claim 68, wherein removing the loading force from the staple causes the first leg and the second leg to move toward each other, applying a compressive force to the first bone and the second bone.
70. 70. The method of claim 69, wherein the inserter comprises a first coupling shaft connected through the top surface of the staple without extending below the bottom surface of the staple, and a second coupling shaft connected through the top surface of the staple without extending below the bottom surface of the staple, and wherein applying the load force comprises biasing the first coupling shaft and the second coupling shaft toward each other.
71. 71. The method of claim 70, wherein removing the inserter from the staple comprises removing the first coupling shaft and the second coupling shaft from the staple from the top surface.
72. 72. The method of claim 71, wherein disengaging the first coupling shaft and the second coupling shaft from the staple causes the first coupling shaft to move away from the second coupling shaft, thereby removing the loading force and causing the first leg of the staple in the first implant hole and the second leg of the staple in the second implant hole to apply the compressive force toward each other.
73. 71. The method of claim 70, wherein the first coupling shaft is connected over the first leg of the staple through the top surface of the staple and the second coupling shaft is connected over the second leg of the staple through the top surface of the staple.
74. 71. The method of claim 70, wherein a connector couples the first coupling shaft and the second coupling shaft to bias the first coupling shaft and the second coupling shaft toward each other and maintain the load force on the staple while the connector couples the first coupling shaft and the second coupling shaft.
75. 75. The method of claim 74, further comprising: removing the connector from the first coupling shaft and the second coupling shaft to move the first coupling shaft away from the second coupling shaft.
76. 76. The method of claim 75, wherein removing the connection removes the loading force on the staple.
77. when the connector couples the first coupling shaft and the second coupling shaft, the first legs of the staples are oriented generally parallel to the second legs of the staples; 76. The method of claim 75, wherein when the connector is removed, the first leg of the staple and the second leg of the staple point toward each other.
78. 76. The method of claim 75, wherein the connector comprises a first receptacle and a second receptacle, the first coupling shaft including a first retention feature and the second coupling shaft including a second retention feature, and the connector couples the first coupling shaft and the second coupling shaft by retaining at least the first retention feature of the first coupling shaft in the first receptacle and the second retention feature of the second coupling shaft in the second receptacle.
79. 79. The method of claim 78, further comprising, prior to removing the connector from the first coupling shaft and the second coupling shaft, moving the first coupling shaft toward the second coupling shaft to disengage the first retaining feature from the first receptacle and moving the second coupling shaft toward the first coupling shaft to disengage the second retaining feature from the second receptacle.
80. 1. A method for fixating and fusing bones, said method comprising: placing a first leg of a staple connected to an inserter into a first implant hole in a first bone and a second leg of the staple connected to the inserter into a second implant hole in a second bone, wherein the first leg of the staple is connected to the second leg of the staple by a bridge, the inserter comprising a first coupling shaft connected to the first leg of the staple, a second coupling shaft connected to the second leg of the staple, and a connector, wherein the first coupling shaft and the second coupling shaft are biased toward each other to apply a load force to the staple, and the connector couples the first coupling shaft and the second coupling shaft to maintain the load force applied to the staple while the connector couples the first coupling shaft and the second coupling shaft; removing the connector from the inserter, thereby removing the load force and moving the first coupling shaft and the second coupling shaft away from each other.
81. 81. The method of claim 80, wherein when the connector couples the first coupling shaft and the second coupling shaft, the first leg of the staple is oriented generally parallel to the second leg of the staple.
82. 82. The method of claim 81, wherein the connector is configured to apply a compressive force toward the first leg of the staple and the second leg of the staple when the connector is removed.
83. 81. The method of claim 80, wherein when the connector is released, the first leg of the staple and the second leg of the staple move toward each other.
84. 84. The method of claim 83, wherein the connector is detached after the first leg of the staple is placed in the first implant hole in the first bone and after the second leg of the staple is placed in the second implant hole in the second bone.
85. 85. The method of claim 84, wherein the connector is removed after a bottom surface of the staple is placed in contact with the first bone and the second bone.
86. 86. The method of claim 85, wherein the first coupling shaft is connected to the first leg of the staple at a position between the bottom surface of the staple and the top surface of the staple, and the second coupling shaft is connected to the second leg of the staple at a position between the bottom surface of the staple and the top surface of the staple, and the first coupling shaft and the second coupling shaft are detached from the staple after the connector is detached from the inserter.
87. 1. A method for fixating and fusing bones, said method comprising: inserting a first wire into a first bone and a second wire into a second bone, the first bone being separated from the second bone by a space; aligning an inserter operably connected to an implant with the first wire and the second wire by placing at least the first wire in a first wire-receiving opening of the inserter and the second wire in a second wire-receiving opening of the inserter; and advancing the inserter along the first wire and the second wire to place the implant in contact with the first bone and the second bone, wherein the implant bridges between the first bone and the second bone.
88. 88. The method of claim 87, wherein the implant is a staple including a first leg and a second leg separated from one another by a bridge, and wherein advancing the inserter along the first wire and the second wire to place the implant in contact with the first bone and the second bone includes placing the first leg of the staple into a first implant hole in the first bone and placing the second leg of the staple into a second implant hole in the second bone.
89. the inserter includes a first coupling shaft connected to a first side of the implant, a second coupling shaft connected to a second side of the implant, and a connector; the first coupling shaft and the second coupling shaft are biased toward each other to apply a load force to the implant; 88. The method of claim 87, wherein the connector couples the first coupling shaft and the second coupling shaft.
90. 90. The method of claim 89, wherein the connector defines the first wire-receiving opening and the second wire-receiving opening.
91. 90. The method of claim 89, further comprising, after advancing the inserter along the first wire and the second wire to place the implant in contact with the first bone and the second bone, removing the connector, thereby separating the first coupling shaft and the second coupling shaft from one another.
92. 92. The method of claim 91, wherein the connector comprises a first receptacle and a second receptacle, the first coupling shaft including a first retention feature and the second coupling shaft including a second retention feature, the first retention feature retaining the first coupling shaft in the first receptacle and the second retention feature retaining the second coupling shaft in the second receptacle.
93. 93. The method of claim 92, further comprising, prior to removing the connector, moving the first coupling shaft and the second coupling shaft toward each other to disengage the first retaining feature from the first receptacle and the second retaining feature from the second receptacle.
94. 90. The method of claim 89, wherein the first coupling shaft and the second coupling shaft each define opposite ends of the implant, and the connector includes a cap disposed over the end of the first coupling shaft and the end of the second coupling shaft.
95. 95. The method of claim 94, wherein the cap includes a first receptacle configured to receive and hold the end of the first coupling shaft and a second receptacle configured to receive and hold the end of the second coupling shaft.
96. 95. The method of claim 94, wherein the cap comprises a surface contour adapted to fit a user's hand, and wherein placing the implant in contact with the first bone and the second bone comprises tamping the surface contour of the cap with the user's hand.
97. aligning a guide with the first bone and the second bone such that the guide is centered with respect to the space separating the first bone and the second bone and the guide defines at least one wire opening, wherein aligning the guide with the first bone and / or the second bone includes placing the at least one wire opening over the first bone and / or the second bone; and 88. The method of claim 87, further comprising inserting the first wire into the first bone and the second wire into the second bone using the at least one wire opening.
98. the at least one wire opening includes a first wire opening and a second wire opening; placing the at least one wire opening over the first bone and / or the second bone includes placing the first wire opening over the first bone and the second wire opening over the second bone; 98. The method of claim 97, wherein inserting the first wire into the first bone and the second wire into the second bone using at least one wire opening comprises inserting the first wire into the first bone through the first wire opening and inserting the second wire into the second bone through the second wire opening.
99. 99. The method of claim 98, wherein the guide defines a body having a length and a width, and the first wire opening and the second wire opening are located opposite each other along the length of the body and opposite each other along the width of the body.
100. 98. The method of claim 97, further comprising inserting a seeker into the space separating the first bone and the second bone, the seeker connected to the guide, and wherein inserting the seeker into the space separating the first bone and the second bone comprises aligning the guide to the first bone and the second bone using the seeker connected to the guide.
101. 88. The method of claim 87, further comprising: inserting a seeker into the space separating the first bone and the second bone, the seeker being separable from the guide, the seeker including a first portion positionable in the space separating the first bone and the second bone and a second portion extending out of the space separating the first bone and the second bone, and wherein aligning the guide with the first bone and the second bone comprises positioning a seeker receiving opening of the guide over the second portion of the seeker extending out of the space.
102. 102. The method of claim 101, wherein the seeker comprises a wire.
103. 98. The method of claim 97, wherein the guide comprises a drill guide, the method further comprising drilling a first implant hole in the first bone using the drill guide and a second implant hole in the second bone using the drill guide.
104. 98. The method of claim 97, further comprising removing a seeker from the space separating the first bone and the second bone and removing the guide from the first wire and the second wire before aligning the inserter operably connected to the implant with the first wire and the second wire.
105. 88. The method of claim 87, wherein the first bone is a metatarsal and the second bone is a cuneiform bone, a tarsometatarsal joint space separates the metatarsal and cuneiform bones, and the implant spans the tarsometatarsal joint space.
106. 88. The method of claim 87, wherein the implant has a top surface and a bottom surface, the inserter is operably connected to the implant at a position spaced apart from the bottom surface, and advancing the inserter along the first wire and the second wire to place the implant in contact with the first bone and the second bone comprises contacting the first bone and the second bone with the bottom surface of the implant.
107. 107. The method of claim 106, wherein the inserter is operably connected to the implant at a position between the top and bottom surfaces of the implant, and contacting the first bone and the second bone with the bottom surface of the implant includes contacting the first bone flush with the bottom surface and contacting the second bone flush with the bottom surface.