Contour guide for ossicular surface modification

The contour guide and implant guide sleeve system addresses the challenge of aligning orthopedic implants on small, curved bones by modifying bone surfaces for precise implant placement, improving stability and efficiency in bone fixation and fusion.

JP2026505580APending Publication Date: 2026-02-16TREACE MEDICAL CONCEPTS INC
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Patent Information

Application Number
JP2025545976
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-09-19
Filing Date
2024-02-08
Publication Date
2026-02-16

AI Technical Summary

Technical Problem

Existing surgical procedures for correcting bone deformities like hallux valgus face challenges in accurately aligning and stabilizing orthopedic implants on small, curved bones, such as those in the foot, due to the difficulty in modifying bone surfaces to receive implants efficiently and accurately.

Method used

The use of a contour guide to modify bone surfaces and an implant guide sleeve to facilitate precise placement of orthopedic implants, such as staples, by aligning and flattening the bone surfaces to accommodate the implant, thereby enhancing stability and efficiency in bone fixation and fusion.

Benefits of technology

The contour guide and implant guide sleeve system ensures more stable, efficient, and accurate implant placement, reducing the time required for implant alignment and promoting effective bone fixation and fusion, particularly in small bones like the metatarsal and cuneiform.

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Abstract

A method of modifying a bone surface to receive an implant includes placing a contour guide on a first bone and a second bone across a separation between the first bone and the second bone, modifying the surface area of ​​at least one of the first bone and the second bone using the contour guide to form the modified surface area on one or both of the first bone and the second bone, and positioning an implant in contact with at least the modified surface area.
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Description

[Technical Field]

[0001] Related Applications This disclosure claims priority to U.S. Provisional Patent Application No. 63 / 444,226, filed February 8, 2023, U.S. Provisional Patent Application No. 63 / 519,036, filed August 11, 2023, and U.S. Provisional Patent Application No. 63 / 583,746, filed September 19, 2023. The contents of each of U.S. Provisional Patent Application No. 63 / 444,226, U.S. Provisional Patent Application No. 63 / 519,036, and U.S. Provisional Patent Application No. 63 / 583,746 are incorporated herein by reference in their entirety.

[0002] FIELD OF THE DISCLOSURE Embodiments of the present disclosure relate generally to devices, systems, and techniques for the ossicular anatomy of the foot. [Background technology]

[0003] Bones in the human body, such as those of the foot, can be anatomically misaligned. 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 being abducted while the phalanges are adducted. This often leads to the development of 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 is directed to devices, systems, and techniques for creating one or more bone surface modifications in one or more bones. For example, although embodiments are disclosed herein that relate to bone surface modification(s) applied to the ossicles anatomy of the foot, other embodiments within the scope of the present disclosure may be applied to bones in other anatomical locations, such as the ossicles anatomy of the hand and / or other bone anatomy elsewhere.

[0006] The embodiments disclosed herein for creating one or more bone surface modifications in one or more bones can be useful, for example, when creating an appropriate modified bone surface in one or more bone portions so that an implant can then be placed therein. In one example, a contour guide can be configured to guide the modification of one or more bone surfaces in one or more surface areas that will contact an implant subsequently placed therein. In this manner, the use of the contour guide can function to modify one or more bone surfaces to create a modified bone surface that is more appropriate for receiving the implant. The embodiments disclosed herein can also include assistance in guiding the placement of an implant on the modified bone surface, for example, using an implant guide sleeve. In some examples, an implant can sleeve can be positioned relative to the contour guide (e.g., contour guide slot) and / or the modified bone surface, with the implant guide sleeve configured to help accurately guide the placement of the implant on the modified bone surface.

[0007] Certain embodiments disclosed herein include devices, systems, and surgical techniques for modifying a bone surface to receive an implant and then guiding the placement of that implant on the modified bone surface. Such embodiments may include modifying the surface on one or more bones, such as two opposing, separated bones. In the case of two opposing bones, the two bones may be separated, for example, by a joint, an osteotomy site, or a fracture to be fused together. In some implementations, the bone surface or surfaces may be modified after one or more bone segments having the bone surface or surfaces have been moved to corrected bone positions following a realignment procedure. Certain contour guide features and implant-guided placement techniques disclosed herein facilitate more stable, efficient, and accurate implant placement and may therefore be useful in promoting bone fixation and resulting fusion when implants are configured to fuse such bone segments more stable, efficient, and accurate. By way of example, features related to contour guides and implant guide placement techniques are disclosed herein that facilitate increasing the stability of implant placement in one or more target bones by modifying the implant placement surface(s) in one or more target bones, and may also help reduce the time required to properly place an implant in one or more target bones while providing a more stable implant receiving surface in the one or more target bones.

[0008] The contour guide can be configured to receive one or more bone surface modifying instruments therein. At least one bone surface modifying instrument received in the contour guide can be configured to remove at least a portion of a surface in one or more bones. For example, a bone surface modifying instrument received in the contour guide can be configured to fracture or otherwise modify (e.g., smooth) the bone at one or more bone surfaces, thereby creating a modified surface region, e.g., one having a modified surface shape in at least two dimensions. In one particular example, a bone surface modifying instrument received in the contour guide can be configured to modify one or more bone surfaces, thereby creating a modified surface region that is flatter in two dimensions than the surface prior to modification using the bone surface modifying instrument received in the contour guide.

[0009] Orthopedic implants can be applied during surgical procedures to bones on opposite sides of a separation between bones, such as a joint separating different bones, or to a fracture or osteotomy separating a single bone into different bony segments. The implant can fix the position of the bones together for healing, during which bone growth closes the separation 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.

[0010] In practice, for example, in the case of the anatomical structure of small bones in the foot, because such bones are relatively small and the outer surfaces of such bones are generally curved, it may be difficult for a clinician to align and stably place an implant on the surface of a target bone. Prior to placing an implant on the target bone surface, a contour guide can be aligned with the target bone surface that will receive the implant. The contour guide can be positioned with respect to the target bone surface, and the guide slot of the contour guide can be aligned with the target bone surface that will receive the implant. A bone surface modifying instrument can be placed in the guide slot, and thus the bone surface modifying instrument can be guided by the contour guide for placement on the aligned target bone surface, whereby a bone surface modification is made on the target bone surface using the bone surface modifying instrument relative to the contour guide. This can facilitate accurate modification of the target bone surface to modify the target bone surface to be more suitable for receiving an implant (e.g., to make the bone-facing surface of the planar implant flatter to better receive it). Once the target bone surface has been modified, the implant can then be placed into the modified target bone surface, for example, using an implant guide sleeve that is positioned against the contour guide and / or against the modified target bone surface.

[0011] One embodiment includes a method of modifying a bone surface to receive an implant, the method embodiment including placing a contour guide on a first bone and a second bone across a separation between the first bone and the second bone, modifying a surface region of at least one of the first bone and the second bone using the contour guide to form a modified surface region on one or both of the first bone and the second bone, and positioning an implant in contact with at least the modified surface region.

[0012] In a further embodiment of this method, using the contour guide to modify the surface area of ​​at least one of the first bone and the second bone includes using the contour guide to define a first surface area on the first bone to form a modified first surface area along the first bone and a second surface area on the second bone to form a modified second surface area along the second bone. Positioning the implant in contact with at least the modified surface areas may also include placing the implant in contact with each of the modified first surface area and the modified second surface area. For example, the implant may have an implant length. The modified first surface area and the modified second surface area may define a length of the modified bone surface along the first bone and the second bone, and the length of the modified bone surface may be equal to or greater than the implant length. As one particular such example, the implant may be a staple, the first bone may be a metatarsal, the second bone may be a cuneiform, and the separation between the first bone and the second bone may be a tarsometatarsal joint space separating the metatarsal and the cuneiform. Also, positioning the implant in contact with at least the modified surface area includes placing a first leg of a staple through the modified first surface area at the metatarsal bone and placing a second leg of a staple through the modified second surface area at the cuneiform bone. In various examples, an implant is placed in contact with each of the modified first surface area and the modified second surface area, such that the implant bridges the separation between the first bone and the second bone.

[0013] In a further embodiment of this method, modifying a surface region of at least one of the first bone and the second bone using the contour guide to form a modified surface region on one or both of the first bone and the second bone includes positioning a bone surface modifying instrument on the contour guide and contacting the surface region of at least one of the first bone and the second bone. For example, the bone surface modifying instrument positioned on the contour guide and contacting the surface region of at least one of the first bone and the second bone can be configured to fracture the bone at the surface region of at least one of the first bone and the second bone. For example, the bone surface modifying instrument positioned on the contour guide and contacting the surface region of at least one of the first bone and the second bone can include at least one of a burr and a saw.

[0014] In a further embodiment of this method, the contour guide includes a contour guide body having an upper side and a lower side. The bottom side includes a guide slot defining a guide slot cross-sectional area that is larger than a cross-sectional area of ​​the implant. Positioning the contour guide includes positioning the lower side of the contour guide against the first bone and the second bone and across a separation between the first bone and the second bone. For example, positioning the lower side of the contour guide against the first bone and the second bone and across a separation between the first bone and the second bone may include positioning the guide slot on the first bone and the second bone and across the separation between the first bone and the second bone. In some such embodiments, the contour guide body includes a guide opening, and modifying a surface region of at least one of the first bone and the second bone using the contour guide to form a modified surface region on one or both of the first bone and the second bone includes placing a bone surface modifying instrument at least partially in the guide opening and at least partially in the guide slot and contacting the surface region of at least one of the first bone and the second bone. For example, the guide opening may be aligned with the guide slot, a contour guide may be positioned on the first bone and the second bone and across the separation between the first and second bones, and a bone surface modification instrument may be inserted first into the guide opening, then into the guide slot, and then placed in contact with a surface region of at least one of the first bone and the second bone to modify the surface region of at least one of the first bone and the second bone.

[0015] In a further embodiment of this method, the method may additionally include positioning an implant guide sleeve on the first bone and the second bone and across the separation between the first bone and the second bone. A contour guide can be positioned on the first bone and the second bone and across the separation between the first bone and the second bone using the implant guide sleeve. In one example, this method embodiment may further include fastening the implant guide sleeve to the first bone and the second bone before positioning the contour guide on the first bone and the second bone and across the separation between the first bone and the second bone using the implant guide sleeve. As another additional or alternative example, modifying a surface region of at least one of the first bone and the second bone using the contour guide to form a modified surface region on one or both of the first bone and the second bone may include modifying the surface region using the contour guide while the contour guide is at least partially positioned within the implant guide sleeve. As another additional or alternative example, after positioning the contour guide using the implant guide sleeve and after modifying the surface region of at least one of the first bone and the second bone using the contour guide to form a modified surface region in one or both of the first bone and the second bone, an inserter operatively connected to the implant may be advanced relative to the implant guide sleeve to position the implant in contact with at least the modified surface region.

[0016] Another embodiment includes a system. This system embodiment includes a contour guide and an implant guide sleeve. The contour guide includes a contour guide body having an upper side and a lower side. The lower side is configured to contact a first bone, a second bone, and a separation between the first and second bones. The lower side includes a guide slot defining a guide slot cross-sectional area. The guide slot cross-sectional area can be configured to receive a bone surface modifying instrument to modify a surface area of ​​at least one of the first bone and the second bone to form a modified surface area on one or both of the first bone and the second bone. The implant guide sleeve defines an interior cross-sectional area larger than the guide slot cross-sectional area. The interior area of ​​the implant guide sleeve is configured to receive the underside of the contour guide body to guide placement and to contact the first bone, the second bone, and a separation between the first and second bones.

[0017] In a further embodiment of the system, the contour guide body may further include at least one guide opening extending from an upper side through at least a portion of the contour guide body. The at least one guide opening may be axially aligned with the guide slot, and the at least one guide opening may be configured to at least partially receive a bone surface modifying instrument. In one example, the at least one guide opening includes a first guide opening and a second guide opening spaced apart from the first guide opening. The first guide opening may extend from an upper side through at least a portion of the contour guide body at a first oblique orientation, and the second guide opening may extend from an upper side through at least a portion of the contour guide body at a second oblique orientation different from the first oblique orientation. Each of the first guide opening and the second guide opening may be configured to receive a bone surface modifying instrument.

[0018] In further embodiments of this system, the interior region of the implant guide sleeve may be further configured to (i) guide the creation of a first implant hole in the modified surface region of the first bone and the creation of a second implant hole in the modified surface region of the second bone, and (ii) guide the placement of a first leg of an implant in the first implant hole in the modified surface region of the first bone and the placement of a second leg of an implant in the second implant hole in the modified surface region of the second bone.

[0019] Another embodiment includes a method of placing an implant in one or more bone portions. This method embodiment includes placing a trial member in one or more bone portions, the trial member simulating the configuration of the implant in the one or more bone portions to determine a relative fit of the trial member in the one or more bone portions, and after placing the trial member in the one or more bone portions, creating one or more implant-receiving openings in the one or more bone portions where the trial member was placed, and placing an implant in the one or more created implant-receiving openings.

[0020] In a further embodiment of this method, the implant is a staple and the trial member simulates at least one dimension of the staple. For example, the trial member can include a trial bridge defining a trial arch, and the trial arch can correspond to the arch defined by the bridge of the staple. For example, determining the relative fit of the trial member in the one or more bone portions can include determining the fit of the trial arch in the one or more bone portions.

[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 1]A and B are frontal views of the foot showing the normal first metatarsal position and an exemplary position with a rotationally misaligned coronal plane, respectively.

[0023] [Figure 2] A and B 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 3] A and B are lateral views of the foot showing the normal position of the first metatarsal and an exemplary position deviated in the sagittal plane, respectively.

[0025] [Figure 4] 1A-1C are flow diagrams of an exemplary surgical technique for positioning and securing an implant.

[0026] [Figure 5A] 1 shows an orthopedic implant in the form of a staple;FIG. [Figure 5B] 1A shows an orthopedic implant in the form of a staple;FIG. 2B is a side view of a longitudinal section of the staple shown in FIG.

[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] 1A and 1B show an embodiment of an inserter, with its components disassembled. [Figure 9B] 1A and 1B show an embodiment of an inserter, and the assembled components of the inserter. [Figure 9C] 10A-10C illustrate an embodiment of an inserter operatively connected to staples such that the staples are in their biased, compressed state when the load force is removed.

[0031] [Figure 10] 1 is a flow diagram of an example of an exemplary surgical technique for positioning an implant, such as a staple, to secure bone for fusion.

[0032] [Figure 11A] 1A-1C illustrate an embodiment of an implant guide sleeve that can be used in an embodiment of a surgical technique for positioning staples to secure bones for fusion. 1D-1C are perspective views of the implant guide sleeve positioned on a first bone, a second bone, and across the separation between the first and second bones. [Figure 11B] 1A-1C illustrate an embodiment of an implant guide sleeve that can be used in an embodiment of a surgical technique for positioning staples to secure bones for fusion. 1D-1C are perspective views of an implant guide sleeve secured to a first bone and a second bone. [Figure 11C] 1A-1C illustrate an embodiment of an implant guide sleeve that can be used in an embodiment of a surgical technique for positioning staples to secure bone for fusion. 1D-1C are perspective views of an implant guide sleeve used to guide the creation of an implant hole. [Figure 11D] 1A-1C illustrate an embodiment of an implant guide sleeve that can be used in an embodiment of a surgical technique for positioning staples to secure bone for fusion. 1D-1C are perspective views of an implant guide sleeve used to align an inserter operatively connected to the staples with the implant guide sleeve. [Figure 11E]1A-1C illustrate an embodiment of an implant guide sleeve that can be used in an embodiment of a surgical technique for positioning staples to secure bones for fusion. 1D is a perspective view of an implant guide sleeve used to advance an inserter relative to the implant guide sleeve to position staples in a first bone and a second bone. [Figure 11F] 1 illustrates an embodiment of an implant guide sleeve that can be used in an embodiment of a surgical technique for positioning staples to secure bones for fusion. 1 is a perspective view of the inserter with staples positioned in contact with the first and second bones after the implant guide sleeve has been removed, where the implant guide sleeve is used to help guide the positioning of the staples in the first and second bones.

[0033] [Figure 12A] 1A-1C illustrate another embodiment of an implant guide sleeve (e.g., one that can be used in an embodiment of a surgical technique for positioning an implant to secure bones for fusion).FIG. 1D is a perspective view of an implant guide sleeve positioned on a first bone and a second bone and across a separation between the first bone and the second bone. [Figure 12B] 1 illustrates another embodiment of an implant guide sleeve (e.g., one that can be used in an embodiment of a surgical technique for positioning an implant to fixate bones for fusion).FIG. 1 is a top view of an implant guide sleeve fixed to a first bone and a second bone and used to guide the creation of an implant hole. [Figure 12C] 1 illustrates another embodiment of an implant guide sleeve (e.g., one that can be used in an embodiment of a surgical technique for positioning an implant to fixate bones for fusion).

[0023] FIG. 1 illustrates a top view of an implant guide sleeve used to align an inserter that is operatively connected to staples with the implant guide sleeve and used to advance the inserter relative to the implant guide sleeve to position the staples in a first bone and a second bone. [Figure 12D] 10A-10C illustrate another embodiment of an implant guide sleeve (e.g., one that can be used in an embodiment of a surgical technique for positioning an implant to secure bone for fusion).

[0034] [Figure 12E] 1 illustrates another embodiment of an implant guide sleeve (e.g., one that can be used in an embodiment of a surgical technique for positioning an implant to secure bone for fusion).FIG. 2 illustrates a top view of an implant guide sleeve in a first size configuration. [Figure 12F] 1 illustrates another embodiment of an implant guide sleeve (e.g., one that can be used in an embodiment of a surgical technique for positioning an implant to secure bone for fusion).FIG. 2 illustrates a top view of the implant guide sleeve in a second size configuration. [Figure 12G] 1 illustrates another embodiment of an implant guide sleeve (e.g., one that can be used in an embodiment of a surgical technique for positioning an implant to secure bone for fusion). FIG. 2 illustrates a perspective view of an implant guide sleeve in a second size configuration. [Figure 12H] 1A-1G show another embodiment of an implant guide sleeve (e.g., one that can be used in an embodiment of a surgical technique for positioning an implant to secure bone for fusion). 1B-1G show the implant guide sleeve embodiments of E-G, but with modified guide sleeve profiles to help minimize the size of the incision required when using the implant guide sleeve. 1C-1D show bottom views of the bone-facing side of the implant guide sleeve in a second size configuration. [Figure 12I]1A-1G show another embodiment of an implant guide sleeve (e.g., one that can be used in an embodiment of a surgical technique for positioning an implant to secure bone for fusion). 1B-1G show the implant guide sleeve embodiments of E-G, but with modified guide sleeve geometries to help minimize the size of the incision required when using the implant guide sleeve. 1C-1D show a perspective view of the bone-facing side of the implant guide sleeve in a second size configuration.

[0035] [Figure 13] FIG. 10 is a side view of an embodiment of an assembled inserter used to position staples in contact with first and second bones.

[0036] [Figure 14] FIG. 14 is a side view of the inserter of FIG. 13 with the connector component removed and the staples urging the first bone and the second bone to secure and apply a compressive force to the first bone and the second bone.

[0037] [Figure 15A] 1A and 1B show an embodiment of a contour guide, and a perspective view of the contour guide and an optional accompanying implant guide sleeve. [Figure 15B] 1A-1C illustrate an embodiment of a contour guide. 1D are elevational views of a contour guide positioned on an implant guide sleeve to modify the surface of one or more bone portions. [Figure 15C] 1A-1C show an embodiment of a contour guide; 1D are perspective views of a contour guide positioned on a different implant guide sleeve embodiment;

[0038] [Figure 15D] 10A-10C are flow diagrams of an exemplary surgical technique for modifying a bone surface to receive an implant using a contour guide.

[0039] [Figure 16A]1A and 1B show an embodiment of a trial member in a drill guide; [Figure 16B] 1A-1C illustrate an embodiment of a trial member in a drill guide. [Figure 16C] 1A-1C illustrate one embodiment of a trial member in a drill guide.

[0040] [Figure 16D] 10A-10C show further embodiments of trial members in the drill guides of A-C including one or more apertures. FIG. 10B shows a perspective view of an exemplary trial member in a drill guide including one or more pin apertures. [Figure 16E] 10A-10C illustrate further embodiments of trial members in the drill guides of A-C including one or more apertures. 10B-10C illustrate top views of an exemplary trial member in a drill guide including one or more pin apertures.

[0041] [Figure 17A] 10A-10C show another embodiment of a trial member in a drill guide; [Figure 17B] 10A-10C show another embodiment of a trial member in a drill guide;

[0042] [Figure 17C] 1A-B show further embodiments of trial members in the drill guides of A-B including one or more pin openings. FIG. 1C shows a perspective view of an exemplary trial member in a drill guide including one or more pin openings. [Figure 17D] 10A-B show further embodiments of trial members in the drill guides of A-B including one or more pin openings. 10B-B show top views of an exemplary trial member in a drill guide including one or more pin openings.

[0043] [Figure 18]FIG. 1 is a side view of an embodiment of a pinning and piercing instrument.

[0044] [Figure 19A] 10A and 10B show another embodiment of a pinning and puncturing instrument with a movable portion and a connecting portion, respectively, and a side view of an embodiment of a pinning and puncturing instrument in a pinned configuration. [Figure 19B] 10A and 10B show another embodiment of a pinning and punching instrument with a movable portion and a connecting portion;FIGS. 10A and 10B show a side view and a side view of an embodiment of a pinning and punching instrument in a punching configuration;

[0045] [Figure 20A] 10A and 10B show another embodiment of a pinning and puncturing instrument with a movable portion and a decoupling portion, respectively, and FIGURE 11A and FIGURE 11B are side views of an embodiment of a pinning and puncturing instrument in a pinned configuration. [Figure 20B] 10A and 10B show another embodiment of a pinning and punching instrument with a movable portion and a decoupling portion;FIGS. 10A and 10B show a side view and a side view of an embodiment of a pinning and punching instrument in a punching configuration;

[0046] [Figure 21] 1A-1C are flow diagrams of an exemplary surgical technique using pinning and drilling instruments to create implant-receiving openings into which implants can be placed.

[0047] [Figure 22A] 1A-1C illustrate the use of an exemplary series of pinning and drilling instruments to create an implant-receiving opening into which an implant can be placed.FIGS. 1A-1C are side views of an exemplary pinning and drilling instrument being advanced toward an exemplary drill guide positioned in a bony portion of the foot. [Figure 22B] 1A-1C illustrate the use of an exemplary series of pinning and drilling instruments to create an implant-receiving opening into which an implant can be placed.FIGS. 1A-1C are side views of pinning and drilling instruments each inserted a first distance into a respective bone portion such that a pin portion of each pinning and drilling instrument is inserted into a respective bone portion. [Figure 22C]10A-10D illustrate the use of an exemplary series of pinning and drilling instruments to create an implant-receiving opening into which an implant can be placed.FIGS. 10A-10D are side views of the pinning and drilling instruments, each inserted a second, further distance into a respective bone portion such that the drill portion of each pinning and drilling instrument is inserted into the respective bone portion.

[0048] [Figure 23] FIG. 10 is an elevational view of another embodiment of a pinning and drilling instrument used in combination with a power driver tool and drill guide.

[0049] [Figure 24] 13A-13C are perspective views of the distal end of additional embodiments of pinning and piercing instruments.

[0050] [Figure 25] FIG. 10 is a perspective view of the distal end of a further embodiment of a pinning and piercing instrument.

[0051] [Figure 26] FIG. 10 is a perspective view of the distal end of another embodiment of a pinning and piercing instrument. DETAILED DESCRIPTION OF THE INVENTION

[0052] In the following description and drawings, like reference characters are used to denote like elements.

[0053] The present disclosure generally relates to devices, systems (e.g., kits), and techniques for fixating one or more bones using one or more guide sleeves for positioning one or more implants, including devices, systems, and techniques for fixating repositioned bones of the foot using one or more guide sleeves for positioning one or more implants. In some examples, the guide sleeves can be used to align and advance implants into one or more bones during a surgical procedure, such as a metatarsal realignment and fixation procedure, to fix the repositioned bone or bones. 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 cutting, fixation procedures, fracture repair, and / or other procedures requiring one or more bones to be set 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 (e.g., the medial cuneiform), such as to correct hallux valgus. One example of such a procedure is the Lapidus procedure. In another example, the devices, systems, and / or techniques can be used to modify 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 of the same bone (e.g., a proximal portion).

[0054] 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.

[0055] 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.

[0056] 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.

[0057] 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, and describe exemplary misalignments that may occur and be corrected and fixed in accordance with the present disclosure. The bony misalignments may be caused by bunions, natural growth deformities, and / or other conditions.

[0058] FIGS. 1A and 1B are front views of a foot 200 showing a normal first metatarsal position and an exemplary position of rotational misalignment in the coronal plane, respectively. FIGS. 2A and 2B are top views of a foot 200 showing an example of a normal first metatarsal position and an exemplary position of misalignment 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 position of misalignment in the sagittal plane, respectively. While FIGS. 1B, 2B, and 3B illustrate misalignment in each plane alone, in practice, the metatarsal 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 metatarsal 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.

[0059] 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 distally connected to phalanges 220, and more specifically, each is connected to a respective proximal phalanx. The first metatarsal 210 is proximally connected to a medial cuneiform 222, the second metatarsal 212 is proximally connected to a middle cuneiform 224, and the third metatarsal 214 is proximally connected to a lateral cuneiform 226. The fourth and fifth metatarsals 216, 218 are proximally connected 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).

[0060] As previously mentioned, FIG. 1A is a front view of a foot 200 showing 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 shows the first metatarsal 210 in a typical rotational position in the frontal plane. FIG. 1B shows 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.

[0061] 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.

[0062] 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.

[0063] Surgical techniques and instruments according to the present disclosure 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.

[0064] Before or after preparing one or both ends of the first metatarsal 210 and the medial cuneiform 222, the clinician can realign the metatarsal relative to the cuneiform. 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 the 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 performing 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 translated position of the first metatarsal 210. Although the present disclosure provides exemplary embodiments of staples as one 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.

[0065] FIG. 4 is a flow diagram of an exemplary method 400 that may include, among other steps, positioning and securing an implant to secure the bones for fusion. As described below, in one example, method 400 can be used to prepare, realign, and secure a tarsometatarsal joint. One or more portions of method 400 related to positioning and securing an implant to secure the bones for fusion (step 450) are further described with reference to FIGS. 5-14. Further details regarding exemplary surgical techniques, including exemplary instruments that may be used during the technique, 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.

[0066] 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 an incision for the skin.

[0067] 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.

[0068] 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.

[0069] 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 to close the IMA 234 between the first metatarsal 210 and the adjacent second metatarsal 212 and / or in the frontal plane (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 the movement of the bone portions. Once the position of the first metatarsal 210 has been shifted, the first metatarsal 210 may be realigned relative to one of the other adjacent bones.

[0070] 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 securing one or more plates to those 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.

[0071] In step 450, method 400 includes positioning 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, placing the implant in step 450 may include using an implant guide sleeve to position an embodiment of a staple (e.g., a compression staple). Positioning an implant, such as a staple, may include using an implant guide sleeve to position at least one leg of the staple on the first metatarsal 210 and at least another leg of the staple on the medial cuneiform 222, with a bridge connecting the legs of the staple extending across the TMT joint 230. Additionally, in some examples, positioning an implant, such as a staple, can include using an implant guide sleeve to position 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 to position 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. As described further herein, the implant guide sleeve can also be used to create the implant hole(s) in the respective bones (e.g., using the same implant guide sleeve to create the implant holes in the respective bones and to guide the positioning of the implants).

[0072] 5A-8 illustrate various embodiments of a staple as one exemplary type of implant that can be positioned using an implant guide sleeve and used to secure bones for fusion.

[0073] 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 fusion.

[0074] 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.

[0075] The legs 502, 504 of the staple 500 can be configured to be positioned in 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, for example, within a range of 8 mm to 25 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 2 mm to 3 mm, which can also provide a length sufficient for secure anchoring within a foot bone. The bridge length 516 of the bridge 506 can be within a range of 12 mm to 20 mm, which can be sufficient to allow the bridge to be positioned across a space (e.g., a joint) between bones of the foot while maintaining the legs 502, 504 on such bones separated by the space. Staples according to the present invention can be configured with dimensions other than those described above, and the invention is not limited in this respect.

[0076] As shown in the example 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 to 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.

[0077] 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 bones 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 perimeter 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 perimeter 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.

[0078] 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 extending from an upper surface 526 of the staple body 501 of the staple 500 toward (e.g., to) a lower 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 upper 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 upper surface 526 of the staple body 501 of the staple 500 toward (e.g., to) the lower surface 528 of the staple body 501 of the staple 500. As one such specific example, the second handling coupling receptacle 511 can extend downward from the upper surface 526 a portion of, but less than the entire length 512 of, the second leg 504. Thus, the first handling coupling 508 and the first handling coupling receptacle 509, as well as the second handling coupling 510 and the second handling coupling receptacle 511, can be accessible from the upper surface 526 of the staple 500, which can be useful in helping to facilitate positioning the lower surface 528 of the staple 500 generally flush with one or more bones (e.g., each of two bones separated by a gap, such as a joint).

[0079] 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 upper surface 526 and the lower surface 528. 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 upper surface 526 and the lower surface 528. 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, such that the first coupling shaft and the second coupling shaft of the inserter are inserted into the first handling coupling receptacle 509 and the second handling coupling receptacle 511, respectively, from the upper 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 outward from the lower surface 528. The illustrated embodiment of the first handling coupling receptacle 509 and the second handling coupling receptacle 511 includes threads extending along the length of the first handling coupling receptacle 509 and the second handling coupling receptacle 511 between the upper surface 526 and the lower surface 528 of the handling coupling receptacle, which 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, and the first and second coupling shafts of the inserter, can include other means for facilitating an operative connection between the respective components.

[0080] 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, placing a biologically compatible wax or other biologically compatible filler material 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 may help prevent biological material from passing through the first handling coupling receptacle 509 and / or the second handling coupling receptacle 511.

[0081] 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, and the cannula 560 can extend along at least a portion (e.g., all) of the length 512 of the legs 502 and / or 504. If included, the cannula 560 can have an inlet at 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 the respective legs 502 and / or 504 between the tines 518, 520. Drugs, structural aids, or other biologically compatible substances can be introduced into the cannula 560 at an inlet (e.g., at the respective handling couplings 508, 510), and the substance can be delivered via one or more outlets 561 to the bone or bones in which the staple 500 is placed.

[0082] 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 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 positioned in the bone, and the staple is guided along the wire.

[0083] The first leg 502 can define a first leg central longitudinal axis 530, with a leg length 512 extending along this longitudinal axis, and the second leg 504 can define a second leg central longitudinal axis 532, with the leg length 512 extending along this longitudinal axis. Similarly, the first handling coupling receptacle 509 can extend from the upper surface 526 toward (e.g., to) the lower surface 528 along a first handling coupling receptacle central longitudinal axis 534, defining a length, and the second handling coupling receptacle 511 can extend from the upper surface 526 toward (e.g., to) the lower surface 528 along a second handling coupling receptacle central longitudinal axis 536, defining a length. Longitudinal

[0084] 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 help increase the cross-sectional area of ​​the intersection of the bridge 506 with the first leg 502 and / or the second leg 504, which can facilitate improving the ability of the staple body 501 of the staple 500 to accommodate the load force applied to the staple 500 in a manner that causes the staple 500 to elastically deform as the staple 500 transitions between its natural, undeformed state and its deformed, inserted state when the load force is applied / removed.

[0085] 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 locations 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 portions of the staple 500 can facilitate increasing the strength of the staple 500 to undergo load forces.

[0086] 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, and can be configured to transition to a deformed, inserted state upon application of a loading force to the staple 500. For example, 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 can assist in applying a compressive force that presses together bones across which the staple 500 is positioned. Upon application of a loading force to the staple 500, the staple 500 can be configured to transition from the undeformed state, in which the staple legs 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 each other) as compared to the natural state. In particular, staple 500 can be configured such that, when a load force is applied to staple 500, first leg 502 is configured to move in direction 540 (e.g., away from bridge 506) and second leg 504 is configured to move in direction 542 (e.g., away from bridge 506) from an undeformed state to a deformed, inserted state. Conversely, when the load force applied to staple 500 is reduced or removed, staple 500 can be configured such that first leg 502 is configured to move from the deformed, inserted state back to the undeformed state in a direction opposite direction 540 (e.g., toward bridge 506) and second leg 504 is configured to move from the deformed, inserted state back to the 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 implant 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 be resiliently biased 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 disclosed herein with respect to staple 500, except where otherwise noted.

[0089] For example, 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 a bridge 606, i.e., the first leg 502 and the third leg 602 on a first side 603 of staple 600, and a second leg 504 and a fourth leg 604 on a second side 605 of bridge 606, i.e., staple 600. In this instance, first side 603 is opposite second side 605. Thus, the arrangement of legs 502, 504, 602, 604 of staple 600 can be a four-legged, in-line arrangement. In some examples, each leg 502, 504, 602, 604 can have an equal length 512, and in the biased, compression-induced state of staple 600 shown in FIG. 6 , bridge 606 can 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 can 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 can contact one or more bones first, and legs 502, 504 can contact one or more bones later, after legs 602, 604 of staple 600 have begun to insert into one or more bones).

[0090] 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 can range from 28 mm to 34 mm, which can be sufficient to allow the bridge to be positioned across a space between bones of the foot (e.g., a joint) while maintaining the legs 502, 602 on one bone and the legs 504, 604 on another bone with the bridge 606 positioned across the space between such bones. By way of example, the bridge length 516 of the bridge 606 can be measured from the central longitudinal axis of the outermost leg 602 on the first side 603 to the central longitudinal axis of the outermost leg 604 on the second side 605.

[0091] Staple 600 can include 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 include materials and teeth 518, 520, and can be configured to transition between a biased, compression-induced state and a deformed, inserted state, as disclosed with respect to staple 500.

[0092] 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.

[0093] 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 therefore 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, where legs 502, 504 are generally aligned across bridge 706 and legs 702, 704 are generally aligned across bridge 706. In some examples, each leg 502, 504, 702, 704 can have an equal length 512, and in the biased, 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.

[0094] 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.

[0095] 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 biased, compression-induced state and a deformed, inserted state, as disclosed with respect to staple 500.

[0096] 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.

[0097] 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, where legs 502, 504 are generally aligned across bridge 706 and legs 702, 704 are generally aligned across bridge 706. In some examples, each leg 502, 504, 702, 704 can have an equal length 512, and in the biased, 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.

[0098] 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.

[0099] 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 positioning 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.

[0100] 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 biased, compression-induced state and a deformed, inserted state, as disclosed with respect to staple 500.

[0101] 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.

[0102] 9A-9C illustrate an embodiment of an inserter 1100. FIG. 9A illustrates the disassembled components of the inserter 1100, FIG. 9B illustrates the assembled components of the inserter 1100, and FIG. 9C illustrates the inserter 1100 operatively connected to a staple 500 with the loading force removed and the staple 500 in its biased, compressed state.

[0103] 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, such as those described elsewhere herein). 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. 9B .

[0104] 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.

[0105] 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.

[0106] 9C , 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 upper surface 526 of the staple 500 and the lower 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 upper surface 526 toward the lower surface 528, but the first coupling shaft 1102 does not extend beyond the lower surface 528. Similarly, the second coupling shaft 1104 can be operably coupled to the second handling coupling 510 in a direction from the upper surface 526 toward the lower surface 528, but the second coupling shaft 1104 does not extend beyond the lower 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).

[0107] 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 upper and / or side surfaces of the bridge, but not the lower 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.

[0108] 9A-9C, the inserter 1100 can 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 can be configured to receive a first wire, and the second wire-receiving opening 1112 can be configured to receive a second wire. The first receptacle 1114 can 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 can 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, connector 1106 includes a first wire-receiving opening 1110 , a second wire-receiving opening 1112 , a first receptacle 1114 , and a second receptacle 1116 .

[0109] 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. 9B . 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. The receptacles 1114, 1116 in the connector 1106 are shown here on the underside of the connector 1106, but in other embodiments the receptacles 1114, 1116 may be located elsewhere in the connector 1106, such as a receptacle 1114 extending along one side of the connector 1106, and a receptacle 1116 extending along another (e.g., opposite) side of the connector 1106.

[0110] 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 positioned at or near the proximal end 1120 of the first coupling shaft 1102, and the second retaining feature 1128 may be positioned at or near the proximal end 1122 of the second coupling shaft 1104. The first retaining feature 1126 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).

[0111] As one such specific example, the connector 1106 shown in the illustrated embodiment of the inserter 1100 can include a cap 1124. In the illustrated embodiment of the inserter 1100, the cap 1124 can be configured to be positioned 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 over the proximal end 1120 of the first coupling shaft 1102 and a second receptacle 1116 of the cap 1124 over the proximal end 1122 of the second coupling shaft 1104, and then moving the cap 1124 while 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 a first wire and a second wire positioned in one or more bones in the respective first wire receiving opening 1110 and second wire receiving opening 1112 when the cap 1124 is moved relative to such wires (e.g., in a direction toward the one or more bones).

[0112] 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 at the location 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 positioning an implant, such as staple 500, in contact with a first bone and a second bone, the 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.

[0113] The inserter 1100 can be configured to place an implant, such as a staple 500, into one or more bones (e.g., using an implant guide sleeve to guide the advancement of the inserter 1100, thereby guiding the placement of the staple 500 in 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. 9B. 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. 9B, 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 urged toward one another to apply a load force to the staple 500, the first leg 502 and the second leg 504 can be oriented generally parallel to one another, as shown in the example of FIGURE 9B. Applying a load force to the staple 500 in this manner can cause the legs 502, 504 to move away from one another in generally parallel directions, which can 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 can 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, as shown in the example of FIGURE 9C. 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.

[0114] 10 is a flow diagram of an embodiment of method 1500. Method 1500 can be used, for example, as a surgical technique for positioning implants, such as staples, to secure bones for fusion. After describing method 1500, FIGS. 11A-14 will be referenced and described to further detail various means that may be used to perform at least some of the steps of method 1500.

[0115] 10 , in step 1510, method 1500 may include positioning an implant guide sleeve. For example, step 1510 may include positioning the implant guide sleeve on a first bone and a second bone and across a separation between the first bone and the second bone. By way of 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 separation between the first bone and the second bone may be a tarsometatarsal joint space separating the metatarsal and cuneiform bones.

[0116] At step 1520, method 1500 can include securing the implant guide sleeve to one or more bones. Step 1520 can be optional when performing method 1500, depending on the particular application and the need to enhance the stabilization that may be provided by securing the implant guide sleeve to one or more bones. By way of example, the implant guide sleeve can be secured by securing the implant guide sleeve to a first bone (e.g., a metatarsal bone, such as the first metatarsal) in which the implant guide sleeve is to be positioned and securing the implant guide sleeve to a second bone (e.g., a cuneiform bone, such as the medial cuneiform) in which the implant guide sleeve is to be positioned. The implant guide sleeve can be so secured using one or more pins, wires, and / or other suitable mechanical fastening means. Thus, to secure the implant guide sleeve to a first bone, a first pin can be inserted through the implant guide sleeve and into the first bone, and to secure the implant guide sleeve to a second bone, a second pin can be inserted through the implant guide sleeve and into the second bone.

[0117] At step 1530, method 1500 may include creating one or more implant holes in one or more bones. The one or more implant holes can be created in one or more bones at step 1530 using the implant guide sleeve positioned at step 1510. For example, the implant guide sleeve can be used to guide the creation of a first implant hole in a first bone in which the implant guide sleeve is positioned and to guide the creation of a second implant hole in a second bone in which the implant guide sleeve is positioned. As one such specific example, the implant guide sleeve (e.g., an interior region defined by the implant guide sleeve) can be used to guide the placement of a drill in a first bone to create the first implant hole and to guide the placement of a drill in a second bone to create the second implant hole. As another such specific example, the implant guide sleeve (e.g., an interior region defined by the implant guide sleeve) can be used to receive and position a drill guide, whereby the drill guide positioned relative to the implant guide sleeve can be used to drill first and second implant holes in the first and second bones, respectively. In this example, the drill guide may be aligned with the implant guide sleeve, and then the drill guide may be placed into the implant guide sleeve.

[0118] At step 1540, method 1500 may include aligning an inserter with the implant guide sleeve. The inserter may be operably connected to an implant, such as a staple. As an example, at step 1540, aligning the inserter operably connected to the implant with the implant guide sleeve may include aligning the inserter and implant on a common axis with an interior region of the implant guide sleeve such that the inserter and implant can move along the common axis within the interior region of the implant guide sleeve. For example, the common axis may extend in a plantar-dorsal direction and perpendicular to the longitudinal axis of the first and / or second bone.

[0119] In step 1550, method 1500 may include advancing an inserter relative to the implant guide sleeve to position an implant in one or more target bones. For example, step 1550 may include advancing the inserter relative to the implant guide sleeve to contact and position the implant against the first bone and the second bone so that the implant bridges the first bone and the second bone. This may include advancing the inserter relative to the implant guide sleeve to position a first leg of a staple in the first implant hole created in step 1530 and a second leg of the staple in the second implant hole created in step 1530. Thus, in various embodiments, the same implant guide sleeve may be used to create implant holes in the first and second bones, and then the inserter and implant coupled to the inserter may also be aligned and advanced relative to the implant guide sleeve to position the implant in the implant holes. In the example where the implant is a staple, when the staple is positioned in the first and second bones using the implant guide sleeve with the staple bridging the first and second bones, the staple can transition from a deformed insertion state to a compression-induced state, as described elsewhere herein, to apply a compressive force between the first and second bones.

[0120] 11A-11F illustrate one embodiment of an implant guide sleeve 2000. The implant guide sleeve 2000 may be used, by way of example, to assist in performing one or more of the steps of the previously described method 1500. Thus, in one exemplary application, the implant guide sleeve 2000 may be used in a surgical technique for positioning an implant, such as a staple, to secure bone for fusion, and one or more aspects described and / or illustrated with respect to the implant guide sleeve 2000 may be applied in the method 1500.

[0121] 11A is a perspective view of an implant guide sleeve 2000 disposed on a first bone 1604 (e.g., a metatarsal bone such as the first metatarsal), a second bone 1606 (e.g., a cuneiform bone such as the medial cuneiform), and positioned across a separation 1602 (e.g., a joint space such as the TMT joint space) between the first bone 1604 and the second bone 1606. In the illustrated example, the first bone 1604 is a metatarsal, more specifically the first metatarsal, the second bone 1606 is a cuneiform bone, more specifically the medial cuneiform, and the separation 1602 is a joint space, more specifically the ankle metatarsal (TMT) joint space, between the first bone 1604 and the second bone 1606. As described elsewhere herein, the embodiments disclosed herein may be similarly applied to other bones of the foot or hand, or more generally to other (e.g., small) bones.

[0122] The implant guide sleeve 2000 may be configured to be placed in one or more bones, such as the first and second bones 1604, 1606, to guide the creation of an implant hole in such one or more bones and / or to guide the placement of an implant, such as a staple, in one or more bones. For example, the implant guide sleeve 2000 may be configured to be placed in the first and second bones 1604, 1606 and configured to (i) guide the creation of a first implant hole in the first bone 1604 and to guide the creation of a second implant hole in the second bone 1606, and (ii) then guide the placement of an implant in the previously created first and second implant holes. With the implant guide sleeve 2000 configured to sequentially guide the creation of an implant hole and subsequent placement of an implant using the same implant guide sleeve 2000 (e.g., the same implant guide sleeve 2000 is maintained in the same general orientation relative to the bones 1604, 1606 for both the creation of the implant hole and the placement of the implant), the implant guide sleeve 2000 can be useful to facilitate a more accurate and efficient implant procedure. This can be particularly useful in applications involving relatively small bones of the foot or hand, where the locations of previously created implant holes in such small bones can otherwise be difficult to identify when attempting to position those relatively small implant holes.

[0123] The implant guide sleeve 2000 can include a guide sleeve body 2002 and a handle 2004. The body 2002 can have a height 2003 extending away from the bone 1604, 1606 when the body 2002 is positioned thereon. The height 2003 can be in the range of 1 to 12 inches, for example, 1 to 6 inches, such that the height is sufficient to provide the guiding functions described herein but not so high as to interfere with work flow in the area of ​​the bone 1604, 1606. The body 2002 can have a length 2007 extending in a direction generally parallel to the longitudinal axis of at least one of the bones 1604, 1606, the length 2007 being in the range of 1 to 12 inches, for example, 1 to 6 inches. The length 2007 can be configured to accommodate corresponding lengths of one or more tools or devices (e.g., drills) used in creating an implant hole in the bone 1604, 1606 and one or more tools or devices (e.g., inserters and staples) used in positioning an implant in the bone 1604, 1606. The body 2002 can also have a width 2009 extending in a direction generally perpendicular to the longitudinal axis of at least one of the bones 1604, 1606, the width 2009 being in a range from 1 / 10 inch to 6 inches, such as in a range from 1 / 10 inch to 1 inch. The width 2009 can be configured to accommodate corresponding widths of one or more tools or devices (e.g., drills) used in creating an implant hole in the bone 1604, 1606 and one or more tools or devices (e.g., inserters and staples) used in positioning an implant in the bone 1604, 1606. The handle 2004 can extend outwardly from the body 2002. The handle 2004 can be configured to be grasped by a user's hand to move and position the body 2002. As shown, the implant guide sleeve 2000 can be configured such that the handle 2004 can extend away from the bones 1604, 1606 when the body 2002 is positioned in the first and second bones 1604, 1606.Also, as shown, the handle 2004 can extend away from the body 2002 in multiple planes to increase the ergonomics and ease of use of the implant guide sleeve 2000. Specifically, the handle 2004 can have a distal end 2005 that extends along a plane that is generally perpendicular to the longitudinal axis of at least one of the first bone 1604 and the second bone 1606. This orientation of the distal end 2005 of the handle 2004 can help to increase the positional accuracy of the placement of the body 2002 relative to the first and second bones 1604, 1606.

[0124] The illustrated embodiment of the implant guide sleeve 2000 can define an interior region 2006 that can be configured to guide the creation of an implant hole and / or the placement of an implant. By way of example, the interior region 2006 can be an interior volume defined by the body 2002. In this example, the interior region 2006 can be defined as an area equal to the length 2007 multiplied by the width 2009 multiplied by the height 2003. The interior region 2006 is defined by the body 2002 and can be configured to receive one or more tools therein for creating an implant hole in the bone 1604, 1606 and / or to receive one or more implants to be placed in the bone 1604, 1606. In the illustrated example, the interior region 2006 can be configured to receive a drill therein for both creating a first implant hole in the first bone 1604 and creating a second implant hole in the second bone 1606 while the drill is within the interior region 2006. Also, for the illustrated example, the interior region 2006 can be configured to receive therein an inserter and an implant operably coupled to the inserter.

[0125] The implant guide sleeve 2000 can include one or more walls 2010, for example, in the body 2002. The one or more walls 2010 can define, at least in part, an interior region 2006 as being bounded by the one or more walls 2010. The walls 2010 making up the illustrated embodiment of the body 2002 include an upper wall 2011 that can extend continuously around the body 2002 at an upper portion of the body 2002 (e.g., opposite the bones 1604, 1606) and a side wall 2012 that extends continuously a distance from the upper wall 2011 downwardly toward the bones 1604, 1606 in the direction of the height 2003. In this configuration, body 2002 includes an upper wall 2011 and a side wall 2012, each extending continuously around the periphery of body 2002 at both the upper portion of body 2002 and along the periphery of body 2002 as body 2002 extends downwardly from upper wall 2011. As shown in the illustrated embodiment, this region including continuous upper wall 2011 and continuous side wall 2012 can form a closed interior region 2006 at the upper portion of body 2002, extending downwardly at least a portion of height 2003. This upper closed interior region extent can be useful for providing guidance within the upper closed interior region for tools or implants advanced into interior region 2006.

[0126] The implant guide sleeve 2000 can include one or more guide legs 2012, for example, on the body 2002. The guide legs 2012 can be positioned on the bottom of the body 2002, and the guide legs 2012 can be configured to function as the anatomical contact surface of the implant guide sleeve 2000. The illustrated embodiment of the body 2002 includes four guide legs 2012 spaced apart from one another, with two such guide legs 2012 at one end of the body length 2007 and two such guide legs 2012 at another opposite end of the body length 2007. In this configuration, as shown in FIG. 11A , the implant guide sleeve 2000 can be positioned such that the two guide legs 2012 at one end of the body length 2007 contact or are positioned on the first bone 1604, while the two guide legs 2012 at the other opposite end of the body length 2007 contact or are positioned on the second bone 1606. The discontinuous configuration of the bottom of the body 2002 formed by the spaced legs 2012 can be useful for creating a window 2014 defined in the body 2002 to allow visualization of the target anatomical structure while the body 2002 is positioned in the target anatomical structure. For example, the window 2014 can be configured to allow visualization of the first bone 1604, the second bone 1606, and the separator 1602 while the body 2002 is positioned on the first and second bones 1604, 1606 and across the separator 1602. Furthermore, because devices guided by the implant guide sleeve 2000 are typically positioned within the interior region 2006 from the top of the body 2002, the window 2014 can allow the device(s) to be advanced downwardly from the top of the body 2002 while still allowing visualization of the first bone 1604, the second bone 1606, and the separator 1602.

[0127] The implant guide sleeve 2000 can further include, for example, at the body 2002, a first end undersurface 2020, a second end undersurface 2021, a first end upper surface 2022, and a second end upper surface 2023. The second end undersurface 2021 can be spaced apart from the first end undersurface 2020. For example, the first end undersurface 2020 can be at a first end of the length 2007, and the second end undersurface 2021 can be at a second, opposite end of the length 2007. The first end upper surface 2022 can be aligned with the first end undersurface 2020 (e.g., with respect to the height 2003), and the second end upper surface 2023 can be aligned with the second end undersurface 2021 (e.g., with respect to the height 2003) and spaced apart from the first end upper surface 2022. For example, the first end upper surface 2022 can be at a first end of the length 2007, and the second end upper surface 2023 can be at a second, opposite end of the length 2007. In the illustrated embodiment, the first and second end upper surfaces 2022, 2023 can be formed by the upper wall 2011, while the first end lower surface 2020 can be formed by the leg 2012 at or on the first bone 1604, and the second end lower surface 2021 can be formed by the leg 2012 at or on the second bone 1606.

[0128] Additionally, the implant guide sleeve 2000 can include one or more structures, for example, in the body 2002, configured to assist in anchoring the implant guide sleeve 2000 in one or more bones. For example, the implant guide sleeve 2000 can include one or more pin openings in the body 2002, each configured to receive a pin therethrough into an adjacent bone. The illustrated embodiment of the implant guide sleeve 2000 includes a first pin opening 2026 and a second pin opening 2028. The first pin opening 2026 is configured to be positioned in the first bone 1604 and to receive a first pin that secures the implant guide sleeve 2000 to the first bone 1604. The second pin opening 2028 is configured to be positioned in the second bone 1606 and to receive a second pin that secures the implant guide sleeve 2000 to the second bone 1606.

[0129] 11B is a perspective view of the implant guide sleeve 2000 secured to the first bone 1604 and the second bone 1606. As previously described, the implant guide sleeve 2000 can be positioned on the first bone 1604 and the second bone 1606 (e.g., in contact with or on the overlying skin) across the separation 1602 between the first bone 1604 and the second bone 1606. If the implant guide sleeve 2000 is secured to the bones 1604, 1606, the implant guide sleeve 2000 can be secured to each of the first bone 1604 and the second bone 1606 after positioning the implant guide sleeve 2000 on the first bone 1604 and the second bone 1606 but before advancing the inserter to position the implants.

[0130] In the illustrated embodiment, the implant guide sleeve 2000 can be secured to the bones 1604, 1606 using pin openings 2026, 2028 in the body 2002. Securing the implant guide sleeve 2000 to the first bone 1604 can include inserting a first pin 2030 into the first bone 1604 through the first pin opening 2026 in the implant guide sleeve 2000. Securing the implant guide sleeve 2000 to the second bone 1606 can also include inserting a second pin 2032 into the second bone 1606 through the second pin opening 2028 in the implant guide sleeve 2000. The implant guide sleeve 2000 can be positionally fixed in the first and second bones 1604, 1606 such that the internal region 2006 defined in the main body 2002 is positioned over at least a portion of the first bone 1604, over at least a portion of the second bone 1606, and over at least a portion of the separation portion 1602.

[0131] 11C is a perspective view of an implant guide sleeve 2000 used to guide the creation of an implant hole. For example, the implant guide sleeve 2000 can be configured to guide the creation of a first implant hole 2034 in a first bone 1604 and to guide the creation of a second implant hole 2036 in a second bone 1606.

[0132] In various embodiments, using the implant guide sleeve 2000 to guide the creation of the first implant hole 2034 in the first bone 1604 and the second implant hole 2036 in the second bone 1606 may include using the implant guide sleeve 2000 to guide the placement of a drill in the first bone 1604 and the second bone 1606 to create the first and second implant holes 2034, 2036. Accordingly, the interior region 2006 of the implant guide sleeve 2000 may be configured to receive a drill therein. In this method, using the implant guide sleeve 2000 to guide the placement of a drill in the first bone 1604 and the second bone 1606 may include using the interior region 2006 defined by the implant guide sleeve 2000 to guide the placement of the drill in the first bone 1604 to create the first implant hole 2034 and the second bone 1606 to create the second implant hole 2036.

[0133] In some such embodiments, the drill guide 2040 can be used in conjunction with the implant guide sleeve 2000 to provide additional guidance in creating the implant holes 2034, 2036. For such embodiments, using the implant guide sleeve 2000 to guide the creation of the first implant hole 2034 in the first bone 1604 and the second implant hole 2036 in the second bone 1606 can include inserting the drill guide 2040 into the implant guide sleeve 2000 and drilling the first implant hole 2034 in the first bone 1604 and the second implant hole 2036 in the second bone 1606 via the drill guide 2040 inserted in the implant guide sleeve 2000.

[0134] The drill guide 2040 can include a handle 2044 and one or more drill guide sleeves 2041, 2042. For example, the handle 2044 can be at a proximal end of the drill guide 2040, and the one or more drill guide sleeves 2041, 2042 can be at an opposite, distal end of the drill guide 2040. The illustrated embodiment of the drill guide 2040 includes a first drill guide sleeve 2041 and a second drill guide sleeve 2042. Each of the first and second drill guide sleeves 2041, 2042 can be configured to receive a drill therein. Additionally, the first drill guide sleeve 2041 can be used to drill a first implant hole 2034 in the first bone 1604, and the second drill guide sleeve 2042 can be used to drill a second implant hole 2036 in the second bone 1606.

[0135] The illustrated embodiment of the implant guide sleeve 2000 can be configured to receive the drill guide 2040 therein. As one such example, the interior region 2006 of the implant guide sleeve 2000 can be configured to receive at least one of the drill guide sleeves 2041, 2042 therein. As shown in FIG. 11C , the interior region 2006 of the implant guide sleeve 2000 is configured to receive both of the drill guide sleeves 2041, 2042 therein. To facilitate placement of both of the drill guide sleeves 2041, 2042 in the interior region 2006, the drill guide 2040 can define a size and shape to fit within the interior region 2006. For example, the drill guide 2040 can be sized and shaped to index the periphery at the distal end of the drill guide 2040 where the drill guide sleeves 2041, 2042 are positioned to the interior region 2006 of the implant guide sleeve 2000, such that the distal end of the drill guide 2040 where the drill guide sleeves 2041, 2042 are positioned can be located in the interior region 2006. As shown for the illustrated embodiment, the drill guide sleeves 2041, 2042 can have a periphery contour (e.g., a curved contour) that substantially matches or is complementary to the adjacent wall 2010 of the implant guide sleeve 2000 that defines the interior region 2006. When the internal region 2006 of the implant guide sleeve is positioned on the first bone 1604 and the second bone 1606, by placing the drill guide sleeves 2041, 2042 in the internal region 2006 positioned in this manner, the drill guide sleeves 2041, 2042 can be drilled through to contact the first bone 1604 and the second bone 1606, respectively.

[0136] In such embodiments where the implant guide sleeve 2000 is configured to receive the drill guide 2040 therein, the drill guide 2040 can be aligned with the implant guide sleeve 2000, and then the drill guide 2040 can be placed into the implant guide sleeve 2000, before creating the implant hole using guidance from the drill guide sleeves 2041, 2042 and the interior region 2006. This can include placing the drill guide sleeves 2041, 2042 of the drill guide 2040 onto the top of the body 2002, aligning them with the interior region 2006, and then moving the drill guide sleeves 2041, 2042 toward and ultimately into the interior region 2006. Thus, positioning the drill guide 2040 in the implant guide sleeve 2000 may include positioning a first drill guide sleeve 2041 within the internal region 2006 defined by the implant guide sleeve 2000, positioning a second drill guide sleeve 2042 within the internal region 2006 defined by the implant guide sleeve 2000, and further positioning the handle 2044 of the drill guide 2040 at least partially outside the internal region 2006 defined by the implant guide sleeve 2000.

[0137] FIG. 11D is a perspective view of the implant guide sleeve 2000 used to align the inserter 1100 operatively connected to the staple 500 with the implant guide sleeve 2000 .

[0138] As an example, aligning a staple 500 operably connected to the inserter 1100 with the implant guide sleeve 2000 can include aligning the staple 500 (and the inserter 1100, etc.) with the interior region 2006 of the implant guide sleeve 2000 on a common axis 2050. This common axial alignment between the interior region 2006 and at least the staple 500 allows the staple 500 to be moved along the common axis 2050 into the interior region 2006 of the implant guide sleeve 2000, for example, by the inserter 1100. For example, as shown, the common axis 2050 can extend in a plantar-dorsal direction and perpendicular to the longitudinal axis of the first and / or second bones 1604, 1606. More specifically, while in the shaft 2050, at least the staple 500 can be aligned with the interior region 2006 by aligning the staple 500 so that it is between the first end upper surface 2022 and the second end upper surface 2023 of the body 2002.

[0139] As previously described herein, the inserter 1100 can include a first coupling shaft 1102 connected to a first side of the staple 500 and a second coupling shaft 1104 connected to a second side of the staple 500. Also, as previously described herein, the inserter 1100 can further include a connector 1106. The connector 1106 can be assembled on the inserter 1100 to couple the first coupling shaft 1102 and the second coupling shaft 1104 when the inserter 1100 is aligned with the implant guide sleeve 2000. When the connector 1106 is coupled to the first coupling shaft 1102 and the second coupling shaft 1104, the first coupling shaft 1102 and the second coupling shaft 1104 are biased toward each other to apply a load force to the staple 500. Thus, when the inserter 1100 is aligned with the implant guide sleeve 2000, when the connector 1106 couples to the first coupling shaft 1102 and the second coupling shaft 1104, the legs 502, 504 of the staple 500 can become approximately parallel to each other as a result of the applied load force.

[0140] FIG. 11E is a perspective view of the implant guide sleeve 2000 used to advance the inserter 1100 relative to the implant guide sleeve 2000 to position the staples 500 in the first bone 1604 and the second bone 1606.

[0141] The inserter 1100 can be advanced relative to the implant guide sleeve 2000 to position the staples 500 in contact with the first bone 1604 and the second bone 1606, such that the staples 500 bridge (e.g., bridge the separation 1602) between the first bone 1604 and the second bone 1606. More specifically, the inserter 1100 can be advanced relative to the implant guide sleeve 2000 to position the staples 500 in the first implant holes 2034 in the first bone 1604, the second implant holes 2036 in the second bone 1606, and across the separation 1602. Positioning the staple 500 in the first and second implant holes 2034, 2036 can include positioning the leg 502 of the staple 500 in (e.g., into) the first implant hole 2034 and positioning the leg 504 of the staple 500 in (e.g., into) the second implant hole 2036. Using the same implant guide sleeve 2000 in the same general orientation relative to the bone 1604, 1606 to both guide the creation of the implant hole in the bone 1604, 1606 and to guide the placement of the implant (e.g., staple 500) in a previously created implant hole can be useful for maintaining a common reference throughout these successive steps to improve the speed and convenience with which the implant (e.g., staple 500) can be placed in the bone 1604, 1606.

[0142] The staples 500, and thus the inserter 1100 operably coupled to the staples 500, can be advanced relative to the interior region 2006 of the implant guide sleeve 2000 to advance the staples 500 (e.g., via the inserter 1100) relative to the implant guide sleeve 2000 and position the staples 500 in the bone 1604, 1606. To accommodate the advancement of the inserter 1100 relative to the implant guide sleeve 2000, the overall length 1150 of the inserter 1100 (e.g., the outermost length envelope defined by the assembled inserter 1100) can be less than the length 2007 of the body 2002, and the overall width 1151 of the inserter 1100 (e.g., the outermost width envelope defined by the assembled inserter 1100) can be less than the width 2009 of the body 2002. Similarly, to accommodate advancement of the staples 500 relative to (e.g., and within) the implant guide sleeve 2000 (e.g., within the interior region 2006), the overall length 590 of the staples 500 can be less than the length 2007 of the body 2002, and the overall width 591 of the staples 500 can be less than the width 2009 of the body 2002. More specifically, to accommodate advancement of the inserter 1100 and staples 500 relative to and within the interior region 2006 of the implant guide sleeve 2000, the interior region 2006 is larger than the corresponding envelope region defined by the assembled inserter 1100 and operably coupled staples 500.

[0143] Advancing the inserter 1100, and thus the staples 500 operably coupled thereto, against the interior region 2006 can include advancing the staples 500, and subsequently the inserter 1100, between the first end upper surface 2022 and the second end upper surface 2023 of the implant guide sleeve 2000. Next, advancing the staples 500 and the trailing inserter 1100 toward the first end lower surface 2020 and the second end lower surface 2021 can continue until the staples 500 contact the first bone 1604 and the second bone 1606, bringing the staples 500 into position adjacent the first end lower surface 2020 and the second end lower surface 2021 as the staples 500 contact the first bone 1604 and the second bone 1606, bridging the first bone 1604 and the second bone 1606.

[0144] When positioning the staples 500 in contact with the bones 1604, 1606 while guided by the implant guide sleeve 2000, the inserter 1100 can be configured to position the staples 500 in generally flush contact with the bones 1604, 1606. The staples 500 include an upper surface 526 and a lower surface 528. The inserter 1100 operatively connects to the staples 500 at locations of the staples 500 spaced from the lower surface 528. As a result of this operative connection spaced from the lower surface 528 of the staples 500, advancing the inserter 1100 relative to the implant guide sleeve 2000 to position the staples 500 in contact with the first and second bones 1604, 1606 can include contacting the first and second bones 1604, 1606 with the lower surfaces 528 of the staples. More specifically, as a result of this operative connection away from the lower surface 528 of the staple 500, the inserter 1100 is operatively connected to the staple 500 at a location of the staple 500 between the upper surface 526 and the lower surface 528, and contacting the first bone 1604 and the second bone 1606 with the lower surface 528 of the staple 500 includes contacting the first bone 1604 flush with the lower surface 528 and contacting the second bone 1606 flush with the lower surface 528.

[0145] 11F is a perspective view of the inserter 1100 with the staples 500 positioned in contact with the first bone 1604 and the second bone 1606 after the implant guide sleeve 2000 has been removed and an implant guide sleeve has been used to help guide the positioning of the staples 500 in the first and second bones 1604, 1606. The implant guide sleeve may be used to guide the creation of the implant hole(s) and / or to guide the positioning of the staples 500 in the bone(s) 1604, 1606, and then the implant guide sleeve may be removed after the staples 500 are positioned in the bone(s) 1604, 1606 as desired. As shown in the example of FIG. 11F, once the implant guide sleeve is removed, the staple legs 502, 504 may be positioned in the implant holes 2034, 2036, respectively. Additionally, with the implant guide sleeve removed, the inserter 1100 may have better access to remove the load force applied to the staple 500, thereby allowing the staple to apply a compressive force to the bone 1604, 1606 and advance the bone 1604, 1606 toward the separation portion 1602.

[0146] 12A-12D illustrate another embodiment of an implant guide sleeve 3000. The implant guide sleeve 3000 can be used, by way of example, to assist in performing one or more of the steps of the previously described method 1500. Thus, in one exemplary application, the implant guide sleeve 3000 can be used in a surgical technique for positioning an implant, such as a staple, to secure bone for fusion, and one or more aspects described and / or illustrated with respect to the implant guide sleeve 3000 can be applied in the method 1500.

[0147] 12A is a top view of an implant guide sleeve 3000 positioned across a first bone 1604, a second bone 1606, and a separation 1602 between the first bone 1604 and the second bone 1606. As with the previously illustrated embodiments of the implant guide sleeve 2000, in the illustrated example, the first bone 1604 is a metatarsal, more specifically the first metatarsal, the second bone 1606 is a cuneiform, more specifically the medial cuneiform, and the separation 1602 is a joint space, more specifically the ankle metatarsal (TMT) joint space between the first bone 1604 and the second bone 1606. As described elsewhere herein, the embodiments disclosed herein may be similarly applied to other bones of the foot or hand, or more generally to other (e.g., small) bones.

[0148] The implant guide sleeve 3000 may be configured to be placed in one or more bones, such as the first and second bones 1604, 1606, to guide the creation of an implant hole in such one or more bones and / or to guide the placement of an implant, such as a staple, in one or more bones 1604, 1606. For example, the implant guide sleeve 3000 may be configured to be placed in the first and second bones 1604, 1606 and configured to (i) guide the creation of a first implant hole in the first bone 1604 and to guide the creation of a second implant hole in the second bone 1606, and (ii) then guide the placement of an implant in the previously created first and second implant holes. With the implant guide sleeve 3000 configured to sequentially guide the creation of an implant hole and subsequent placement of an implant using the same implant guide sleeve 3000 (e.g., the same implant guide sleeve 3000 is maintained in the same general orientation relative to the bones 1604, 1606 for both the creation of the implant hole and the placement of the implant), the implant guide sleeve 3000 can be useful to facilitate a more accurate and efficient implant procedure. This can be particularly useful in applications involving relatively small bones of the foot or hand, where the locations of previously created implant holes in such small bones can otherwise be difficult to identify when attempting to position those relatively small implant holes.

[0149] The implant guide sleeve 3000 can include a guide sleeve body 3002 and a handle 3004. The body 3002 can have a height (into / out of the viewing angle of the plan view shown in FIG. 12A ) that extends away from the bone 1604, 1606 when the body 3002 is positioned thereon. This height of the body 3002 can be sufficient to provide the guiding functions described herein, but not so high as to interfere with workflow in the region of the bone 1604, 1606. The body 3002 can have a length 3007 that extends in a direction generally parallel to the longitudinal axis of at least one of the bones 1604, 1606, and the length 3007 can be in the range of 1 to 12 inches, for example, in the range of 1 to 6 inches. The length 3007 can be configured to accommodate corresponding lengths of one or more tools or devices (e.g., drills) used in creating an implant hole in the bone 1604, 1606 and one or more tools or devices (e.g., inserters and staples) used in positioning an implant in the bone 1604, 1606. The body 3002 can also have a width 3009 extending in a direction generally perpendicular to the longitudinal axis of at least one of the bones 1604, 1606, the width 3009 being in a range of 1 / 10 inch to 6 inches, such as in a range of 1 / 10 inch to 1 inch. The width 3009 can be configured to accommodate corresponding widths of one or more tools or devices (e.g., drills) used in creating an implant hole in the bone 1604, 1606 and one or more tools or devices (e.g., inserters and staples) used in positioning an implant in the bone 1604, 1606. The handle 3004 can extend outwardly from the body 3002. The handle 3004 can be configured to be grasped by a user's hand to move and position the body 3002. As shown, the implant guide sleeve 3000 can be configured such that the handle 3004 can extend away from the bones 1604, 1606 when the body 3002 is positioned in the first and second bones 1604, 1606.

[0150] The illustrated embodiment of the implant guide sleeve 3000 can define an interior region 3006 that can be configured to guide implant hole creation and / or implant placement. By way of example, the interior region 3006 can be an interior volume defined by the body 3002. In this example, the interior region 3006 can be defined as an area equal to the length 3007 multiplied by the width 3009, and the interior volume can be defined as a volume equal to the length 3007 multiplied by the width 3009 multiplied by the height (measured in the into / out of the page direction at the plan view angle depicted in FIG. 12A ). The interior region 3006 can be configured to receive one or more tools therein for creating implant holes in the bone 1604, 1606 and / or to receive one or more implants therein for placement in the bone 1604, 1606. In the illustrated example, the interior region 3006 can be configured to receive a drill therein both to create a first implant hole in the first bone 1604 and to create a second implant hole in the second bone 1606 while the drill is within the interior region 3006. Also, for the illustrated example, the interior region 3006 can be configured to receive an inserter therein and an implant operably coupled to the inserter.

[0151] The implant guide sleeve 3000 can further include, for example, on the body 3002, a first end undersurface 3020, a second end undersurface 3021, a first end upper surface 3022, and a second end upper surface 3023. The second end undersurface 3021 can be spaced apart from the first end undersurface 3020. For example, the first end undersurface 3020 can be at a first end of the length 3007, and the second end undersurface 3021 can be at a second, opposite end of the length 3007. The first end upper surface 3022 can be aligned (e.g., in height) with the first end undersurface 3020, and the second end upper surface 3023 can be aligned (e.g., in height) with the second end undersurface 3021 and spaced apart from the first end upper surface 3022. For example, first end surface 3022 can be at a first end of length 3007 and second end surface 3023 can be at a second, opposite end of length 3007 .

[0152] Further, the implant guide sleeve 3000 can include a first guide arm 3060 and a second guide arm 3062, as shown for the illustrated embodiment. The first guide arm 3060 and the second guide arm 3062 can be movable. For example, each guide arm 3060, 3062 can be movable relative to the handle 3004. By way of example, the first guide arm 3060 and the second guide arm 3062 can be rotationally coupled to the handle 3004, such that moving the first guide arm 3060 includes rotating the first guide arm 3060 relative to the handle 3004, and moving the second guide arm 3062 includes rotating the second guide arm 3062 relative to the handle 3004. By way of example, the interior region 3006 can be the region between the first guide arm 3060 and the second guide arm 3062, and moving the first and second guide arms 3060, 3062 can change the size of the interior region 3006. 12A , the first guide arm 3060 and the second guide arm 3062 are spaced apart by a first guide arm distance 3064. In embodiments including first and second guide arms 3060, 3062, the width 3009 may be the distance defined by the distance between the outer diameters of the guide arms 3060, 3062, and the guide arm distance (e.g., the first guide arm distance 3064) may be defined by the distance between the inner diameters of the guide arms 3060, 3062.

[0153] The implant guide sleeve 3000 may also include one or more structures, for example, in the body 3002, configured to assist in anchoring the implant guide sleeve 3000 in one or more bones. For example, the implant guide sleeve 3000 may include one or more pin openings in the body 3002, each configured to receive a pin therethrough into an adjacent bone. The illustrated embodiment of the implant guide sleeve 3000 includes a first pin opening 3026 and a second pin opening 3028. The first pin opening 3026 is configured to be positioned in the first bone 1604 and to receive a first pin that secures the implant guide sleeve 3000 to the first bone 1604. The second pin opening 3028 is configured to be positioned in the second bone 1606 and to receive a second pin that secures the implant guide sleeve 3000 to the second bone 1606. The first pin opening 3026 can be in the first guide arm 3060 and the second pin opening 3028 can be in the second guide arm 3062, such that when the first and second guide arms 3060, 3062 move relative to the handle 3004, the first and second pin openings 3026, 3028 also move relative to the handle 3004.

[0154] FIG. 12B is a top view of an implant guide sleeve 3000 secured to the first bone 1604 and the second bone 1606 and used to guide the creation of the implant holes 2034, 2036.

[0155] As mentioned above, the size of the implant guide sleeve 3000 can be adjusted. For example, FIG. 12B shows the implant guide sleeve 3000 in a second size configuration, while FIG. 12A shows the implant guide sleeve 3000 in a first, smaller size configuration. The implant guide sleeve 3000 can be configured to adjust between at least a first, smaller size configuration and a second, larger size configuration. The first size configuration of the implant guide sleeve 3000 and the second size configuration of the implant guide sleeve can define different cross-sectional areas. For example, the first size configuration of the implant guide sleeve 3000 can define a first interior cross-sectional area bounded by the implant guide sleeve 3000 at the interior region 3006, while the second size configuration of the implant guide sleeve 3000 can define a second interior cross-sectional area bounded by the implant guide sleeve 3000 at the interior region 3006. The second interior cross-sectional area can be larger than the first interior cross-sectional area.

[0156] As an example, the size of the implant guide sleeve 3000 can be adjusted by moving the first guide arm 3060 and / or the second guide arm 3062. Specifically, adjusting the size of the implant guide sleeve 3000 between the first size configuration and the second size configuration can include rotating the first guide arm 3060 relative to the handle 3004 and rotating the second guide arm 3062 relative to the handle 3004. In the first size configuration, the first guide arm 3060 and the second guide arm 3062 can be separated by a first guide arm distance 3064 (shown in FIG. 12A , e.g., measured between the guide arms 3060, 3062 at the interior region 3006), and in the second size configuration, the first guide arm 3060 and the second guide arm 3062 can be separated by a second guide arm distance 3066 (shown in FIG. 12B , e.g., measured between the guide arms 3060, 3062 at the interior region 3006). The second guide arm distance 3066 may be greater than the first guide arm distance. As an example, the first guide arm distance 3064 may be less than the length of the implant (e.g., less than the length 590 of the staples 500) to be guided and positioned using the implant guide sleeve 3000 (e.g., using the interior region 3006), while the second guide arm distance 3066 may be greater than the length of the implant (e.g., less than the length 590 of the staples 500) to be guided and positioned using the implant guide sleeve 3000 (e.g., using the interior region 3006). In this example, the guide arm distance would then need to be adjusted to the greater second guide arm distance 3066 before the implant can be positioned with guidance from the implant guide sleeve 3000.

[0157] Being able to adjust the size of the implant guide sleeve 3000 can be useful to allow for smaller access sites (e.g., smaller incision sizes on the bones 1604, 1606). That is, the implant guide sleeve 3000 can be in a smaller, first size configuration (e.g., shown in FIG. 12A ) when the implant guide sleeve 3000 is being moved through an access site (e.g., through an incision) toward the bones 1604, 1606, and the implant guide sleeve 3000 is positioned across the separation 1602 at the bones 1604, 1606. Then, after the implant guide sleeve 3000 has been moved through the access site (e.g., through an incision) and positioned at or on the bones 1604, 1606, the implant guide sleeve 3000 can be adjusted to a larger, second size configuration (e.g., shown in FIG. 12B ). Thus, prior to positioning the implant guide sleeve 3000 on the first bone 1604, the second bone 1606, and across the separation 1602, the implant guide sleeve 3000 can be inserted in a first size configuration through an incision exposing at least a portion of each of the first bone 1604, the second bone 1606, and the separation 1602. Also, after inserting the implant guide sleeve 3000 in the first size configuration through the incision, the size of the implant guide sleeve 3000 can be adjusted from the first size configuration to a second size configuration. Additionally, in a further embodiment, the implant guide sleeve 3000 can be adjusted from the first size configuration to the second size configuration prior to advancing the inserter 1100 relative to the implant guide sleeve 3000. Additionally, in still further embodiments, the implant guide sleeve 3000 may be secured to each of the first bone 1604 and the second bone 1606 after adjusting the implant guide sleeve 3000 from the first size configuration to the second size configuration and before advancing the inserter 1100 relative to the implant guide sleeve 3000.

[0158] 12B shows the implant guide sleeve 3000 secured to the first bone 1604 and the second bone 1606. As previously described, the implant guide sleeve 2000 can be positioned on the first bone 1604 and the second bone 1606 (e.g., in contact with or on the overlying skin) across the separation 1602 between the first bone 1604 and the second bone 1606. If the implant guide sleeve 3000 is secured to the bones 1604, 1606, the implant guide sleeve 3000 can be secured to each of the first bone 1604 and the second bone 1606 after positioning the implant guide sleeve 3000 on the first bone 1604 and the second bone 1606 but before advancing the inserter to position the implant.

[0159] In the illustrated embodiment, the implant guide sleeve 3000 can be secured to the bones 1604, 1606 using pin openings 3026, 3028 in the body 3002. Securing the implant guide sleeve 3000 to the first bone 1604 can include inserting a first pin 2030 into the first bone 1604 through the first pin opening 3026 in the implant guide sleeve 3000. Securing the implant guide sleeve 3000 to the second bone 1606 can include inserting a second pin 2032 into the second bone 1606 through the second pin opening 3028 in the implant guide sleeve 3000. The implant guide sleeve 3000 can be positionally fixed in the first and second bones 1604, 1606 such that an internal region 3006 defined in the main body 3002 (e.g., between the guide arms 3060, 3062) is positioned over at least a portion of the first bone 1604, over at least a portion of the second bone 1606, and over at least a portion of the separation portion 1602.

[0160] The implant guide sleeve 3000 can further include a drill guide 3040 to provide guidance in creating the implant holes 2034, 2036. Using the implant guide sleeve 3000 to guide the creation of the first implant hole 2034 in the first bone 1604 and the second implant hole 2036 in the second bone 1606 can include inserting the drill guide 3040 into the implant guide sleeve 3000 and drilling the first implant hole 2034 in the first bone 1604 and the second implant hole 2036 in the second bone 1606 via the drill guide 3040 inserted into the implant guide sleeve 3000. More specifically, as an example, the drill guide 3040 can be inserted into the interior region 3006 and between the guide arms 3060, 3062, and in such an example, the interior region 3006 with the drill guide 3040 inserted can be used to guide the placement of a drill in the first bone 1604 to guide the creation of the first implant hole 2034 and to guide the placement of a drill in the second bone 1606 to guide the creation of the second implant hole 2036.

[0161] The drill guide 3040 can include a handle 3044 (best seen in FIG. 12D ) and one or more drill guide sleeves 3041, 3042. For the illustrated embodiment, as further described with reference to FIG. 12D , the drill guide 3040, including the one or more drill guide sleeves 3041, 3042, can be integrated with the implant guide sleeve 3000. For example, the handle 3044 can be at a proximal end of the drill guide 3040, and the one or more drill guide sleeves 3041, 3042 can be at an opposite, distal end of the drill guide 3040. The illustrated embodiment of the drill guide 3040 includes a first drill guide sleeve 3041 and a second drill guide sleeve 3042. Each of the first and second drill guide sleeves 3041, 3042 can be configured to receive a drill therein. Additionally, the first drill guide sleeve 3041 can be used to drill a first implant hole 2034 in the first bone 1604, and the second drill guide sleeve 3042 can be used to drill a second implant hole 2036 in the second bone 1606.

[0162] The implant guide sleeve 3000 can be configured to receive the drill guide 3040 therein. As one such example, the interior region 3006 of the implant guide sleeve 3000 can be configured to receive at least one of the drill guide sleeves 3041, 3042 therein. As shown in FIG. 12B , the interior region 3006 of the implant guide sleeve 3000 is configured to receive both of the drill guide sleeves 3041, 3042 therein. To facilitate placement of both drill guide sleeves 3041, 3042 in the interior region 3006, the drill guide 3040 can define a size and shape to fit within the interior region 3006. For example, the drill guide 3040 can be sized and shaped to index the size and shape of the periphery at the distal end of the drill guide 3040 where the drill guide sleeves 3041, 3042 are positioned to the interior region 3006 of the implant guide sleeve 3000, such that the distal end of the drill guide 3040 where the drill guide sleeves 3041, 3042 are positioned can be located in the interior region 3006. As shown for the illustrated embodiment, the drill guide sleeves 3041, 3042 can have a periphery contour (e.g., curved contour) that substantially matches or is complementary to the inner periphery contour (e.g., curved contour) of each of the adjacent guide arms 3060, 3062 that define the interior region 3006. When the internal region 3006 of the implant guide sleeve is positioned on the first bone 1604 and the second bone 1606, by placing the drill guide sleeves 3041, 3042 in the internal region 3006 positioned in this manner, the drill guide sleeves 3041, 3042 can be drilled through to contact the first bone 1604 and the second bone 1606, respectively.

[0163] The drill guide 3040 of the illustrated embodiment can be movably coupled to the implant guide sleeve 3000. The drill guide 3040 can be moved relative to the implant guide sleeve 3000 after inserting the implant guide sleeve 3000 (e.g., in a first size configuration) through an incision exposing at least a portion of each of the first bone 1604, the second bone 1606, and the separation 1602, but before creating an implant hole using guidance from the drill guide sleeves 3041, 3042 and the interior region 3006. Further, this can include moving the drill guide 3040 relative to the implant guide sleeve 3000 after adjusting the size of the implant guide sleeve 3000 between the first and second size configurations (e.g., after adjusting the size of the implant guide sleeve 3000 from the first size configuration to the second size configuration).

[0164] Moving the drill guide 3040 relative to the implant guide sleeve 3000 can include moving the first drill guide sleeve 3041 and / or the second drill guide sleeve 3042 relative to the implant guide sleeve 3000. By way of example, the drill guide 3040 can be movable relative to the implant guide sleeve 3000 between a retracted position 3070 (e.g., shown in FIG. 12A ) and an extended position 3071 (e.g., shown in FIG. 12B ). In the retracted position 3070, each of the first drill guide sleeve 3041 and the second drill guide sleeve 3042 can be retracted relative to the implant guide sleeve 3000. For example, the first drill guide sleeve 3041 and the second drill guide sleeve 3042 can be retracted relative to the implant guide sleeve 3000 such that each of the first drill guide sleeve 3041 and the second drill guide sleeve 3042 is retracted outside the interior region 3006 in a direction toward the handle 3004. When the first drill guide sleeve 3041 and the second drill guide sleeve 3042 are in the retracted position, the guide arms 3060, 3062 can be permitted to move between different size configurations defined by the interior region 3006. In the extended position 3071, each of the first drill guide sleeve 3041 and the second drill guide sleeve 3042 can be aligned with the implant guide sleeve 3000. For example, the first drill guide sleeve 3041 and the second drill guide sleeve 3042 can be extended relative to the handle 3004 such that each of the first drill guide sleeve 3041 and the second drill guide sleeve 3042 is extended to be positioned and residing within the interior region 3006. More specifically, in one example, in the extended position 3071, the first drill guide sleeve 3041 can be nested on the inner surface 3072 of the first drill guide sleeve 3041, and the second drill guide sleeve 3042 can be nested on the inner surface 3073 of the second drill guide sleeve 3042.To accommodate such nesting, for example, the inner surface 3074 of the guide arm 3060 defining the interior region 3006 can have a first geometric shape that is complementary to the outer surface 3072 of the first drill guide sleeve 3041, and the inner surface 3075 of the guide arm 3062 defining the interior region 3006 can have a second geometric shape that is complementary to the outer surface 3073 of the second drill guide sleeve 3042. These complementary surfaces allow the first drill guide sleeve 3041 to nest on the inner surface 3074 of the guide arm 3060, and the second drill guide sleeve 3042 to nest on the inner surface 3075 of the guide arm 3062, in the extended position 3071. Moreover, when the first drill guide sleeve 3041 and the second drill guide sleeve 3042 are in the extended position, the guide arms 3060, 3062 can be prevented from moving between the different size configurations defined by the interior region 3006.

[0165] To help facilitate movement of the drill guide 3040, the implant guide sleeve 3000 can include an actuator 3080 (best shown in FIG. 12D ) configured to move the drill guide 3040. In the illustrated embodiment, the actuator 3080 is included in the handle 3044 of the drill guide 3040. The actuator 3080 can be configured such that, when actuated, the actuator 3080 causes the drill guide 3040 to move relative to the implant guide sleeve 3000 from a retracted position 3070 to an extended position 3071. For example, the drill guide 3040 can be maintained in the extended position 3071 while an actuation input is applied by the actuator 3080, and the drill guide 3040 can return to the retracted position 3070 when the actuation input is removed from the actuator 3080. In the illustrated embodiment, the actuation input on the actuator 3080 may be a force applied by the user's hand (e.g., finger) to move the drill guide sleeves 3041, 3042 into the interior region 3006 of the implant guide sleeve 3000.

[0166] The drill guide 3040 can further include a visual marker 3082. The visual marker 3082 can be configured to facilitate aiding in alignment at the separation 1602 between the first bone 1604 and the second bone 1606. The visual marker 3082 can be movable with the drill guide 3040. Thus, in the retracted position 3070 of the drill guide 3040, the visual marker 3082 can be retracted relative to the implant guide sleeve 3000 and the interior region 3006. Meanwhile, in the extended position 3071 of the drill guide 3040, the visual marker 3082 can extend outward relative to the handle 3004 and be aligned with the implant guide sleeve 3000 and the interior region 3006. The presence of the visual marker 3082 when extended into the interior region 3006 can be useful, for example, to provide reference to the separation portion 1602, the first bone 1604, and the second bone 1606 when creating the implant holes 2034, 2036.

[0167] FIG. 12C is a top view of an implant guide sleeve 3000 used to align the inserter 1100. In this instance, the inserter 1100 is shown operatively connected to a staple 500. The staple 500 and associated inserter 1100 can be aligned with the implant guide sleeve 3000, which can be used to advance the staple 500 and position it in the first bone 1604 and the second bone 1606 by advancing the inserter 1100 relative to the implant guide sleeve 3000. The use of the implant guide sleeve 3000 to guide the positioning of the staple 500 in contact with the first and second bones 1604, 1606 can be similar to that described earlier herein with respect to aligning and advancing the staple 500 and associated inserter 1100 using the implant guide sleeve 2000 (e.g., with reference to FIGS. 11D-11F).

[0168] As an example, aligning the inserter 1100 operably connected to the staple 500 with the implant guide sleeve 3000 can include aligning the staple 500 (and the inserter 1100, etc.) with the interior region 3006 of the implant guide sleeve 3000 on a common axis 2050. This common axial alignment between the interior region 3006 and at least the staple 500 allows the staple 500 to be moved along the common axis 2050 into the interior region 3006 of the implant guide sleeve 3000, for example, by the inserter 1100. For example, as shown, the common axis 2050 can extend in a plantar-dorsal direction and perpendicular to the longitudinal axis of the first and / or second bones 1604, 1606. In some cases, this can include aligning at least the staples 500 with the interior region 3006 by aligning at least the staples 500 to be between the first end top surface 3022 and the second end top surface 3023 of the body 3002 while on the axis 2050. Similarly, in some cases, this can include aligning at least the staples 500 with the interior region 3006 by aligning at least the staples 500 to be between the first guide arm 3060 and the second guide arm 3062. For example, the staples 500 can be aligned with the interior region 3006 by aligning the staples 500 at the common axis 1150 such that the length and width of the staples 500 are within the span between the guide arms 3060, 3062 (e.g., within the second guide arm distance 3066) and the width between the guide arms 3060, 3062 (e.g., within the width 3009). To facilitate alignment of the staple 500 with the implant guide sleeve 3000, the implant guide sleeve 3000 can be in a larger second size configuration when the staple 500 is aligned with the implant guide sleeve 3000 and / or when the staple 500 is advanced relative to the implant guide sleeve 3000 to position the staple 500 in the bone 1604, 1606.Thus, it is the case in various embodiments that the size of the implant guide sleeve 3000 is adjusted to a larger size (e.g., adjusted to have a larger internal region 3006) before advancing the staple 500 relative to the implant guide sleeve 3000 to position the staple 500 in the bone 1604, 1606.

[0169] Once the staples 500 are aligned with the implant guide sleeve 3000, the staples 500 can be advanced relative to the implant guide sleeve 3000 to position the staples 500 in contact with the first bone 1604 and the second bone 1606, such that the staples 500 bridge (e.g., bridge the separation 1602) between the first bone 1604 and the second bone 1606. More specifically, the staples 500 can be advanced (e.g., via the inserter 1100) relative to the implant guide sleeve 3000 to position the staples 500 in the first implant holes 2034 in the first bone 1604, the second implant holes 2036 in the second bone 1606, and across the separation 1602. Positioning the staple 500 in the first and second implant holes 2034, 2036 can include positioning the leg 502 of the staple 500 in (e.g., within) the first implant hole 2034 and positioning the leg 504 of the staple 500 in (e.g., within) the second implant hole 2036. As previously described herein, using the same implant guide sleeve 3000, in the same general orientation relative to the bone 1604, 1606, to both guide the creation of the implant holes in the bone 1604, 1606 and to guide the placement of the staple 500 in the previously created implant holes can be useful to maintain a common reference throughout these successive steps.

[0170] To advance the staples 500 relative to the implant guide sleeve 3000 (e.g., via the inserter 1100) and position the staples 500 in the bone 1604, 1606, the staples 500, and thus the inserter 1100 operably coupled to the staples 500, can be advanced relative to the interior region 3006 of the implant guide sleeve 3000. To accommodate the advancement of the staples 500 relative to (e.g., further within) the implant guide sleeve 3000 (e.g., within the interior region 3006), the overall length 590 of the staples 500 can be less than the length 3007 of the body 3002 (e.g., less than the greater second guide arm distance 3066) and the overall width 591 of the staples 500 can be less than the width 3009 of the body 3002 (e.g., less than the width defined by the inner surfaces 3074, 3075 of the guide arms 3060, 3062). Indeed, because the staples 500 can be advanced through the same interior region 3006 in which the drill guide sleeves 3041, 3042 are positioned (e.g., when creating an implant hole prior to advancing the staples 500), the staples 500 can have a width similar to the width of those drill guide sleeves 3041, 3042. Similarly, to accommodate advancement of the inserter 1100 relative to the implant guide sleeve 3000, the overall length 1150 of the inserter 1100 (e.g., the outermost length envelope defined by the assembled inserter 1100) can be less than the length 3007 of the body 3002, and the overall width 1151 of the inserter 1100 (e.g., the outermost width envelope defined by the assembled inserter 1100) can be less than the width 3009 of the body 3002. More specifically, to accommodate advancement of the staple 500 and accompanying inserter 1100 against and within the interior region 3006 of the implant guide sleeve 3000, the interior region 3006 may be larger than the corresponding envelope region defined by the assembled inserter 1100 and operably coupled staple 500.

[0171] Advancing the staples 500, and thus the inserter 1100 operably coupled to the staples 500, against the interior region 3006 can include advancing the staples 500, and subsequently the inserter 1100, between the first end upper surface 3022 and the second end upper surface 3023 of the implant guide sleeve 3000. Next, advancing the staples 500 and the trailing inserter 1100 toward the first end lower surface 3020 and the second end lower surface 3021 can continue until the staples 500 contact the first bone 1604 and the second bone 1606, bringing the staples 500 into position adjacent the first end lower surface 3020 and the second end lower surface 3021 when the staples 500 contact the first bone 1604 and the second bone 1606, bridging the first bone 1604 and the second bone 1606.

[0172] As described above with respect to the advancement of the staples 500 relative to the implant guide sleeve 2000, the implant guide sleeve 3000 can similarly guide the advancement of the staples 500 to position the staples 500 in contact with the bone 1604, 1606. That is, when using the implant guide sleeve 3000 to guide the placement of the staple 500, the inserter 1100 can be configured to position the staple 500 in approximately flush contact with the bones 1604, 1606 because the inserter 1100 can be operably connected to the staple 500 at a location on the staple 500 that is spaced from the lower surface 528 of the staple 500, such that advancing the inserter 1100 relative to the implant guide sleeve 3000 to position the staple 500 in contact with the first bone 1604 and the second bone 1606 can include contacting the first bone 1604 and the second bone 1606 with the lower surface 528 of the staple (e.g., bringing the first bone 1604 in flush contact with the lower surface 528 and the second bone 1606 in flush contact with the lower surface 528).

[0173] 12D is a bottom view of the implant guide sleeve 3000 in isolation. Specifically, FIG. 12D illustrates an exemplary configuration of a drill guide 3040 in the implant guide sleeve 3000, such as when the drill guide 3040 is integrated with the implant guide sleeve 3000. The illustrated embodiment of the drill guide 3040 includes a first drill guide sleeve 3041, a second drill guide sleeve 3042, and a handle 3044. The first and second drill guide sleeves 3041 and 3042 can be at a distal end 3090 of the drill guide 3040, and the handle 3044 can be at a proximal end 3091 of the drill guide.

[0174] As described above, the drill guide 3040 can be movably coupled to the implant guide sleeve 3040, such that, for example, the drill guide 3040 is movable in the direction 3092 relative to the handle 3004. The drill guide 3040 can be movably coupled to the implant guide sleeve 3040 in any of a variety of ways, including any suitable type of mechanical translational coupling (e.g., a track that receives a sliding element). The drill guide 3040 movably coupled to the implant guide sleeve 3000 can include a first drill guide sleeve 3041 and a second drill guide sleeve 3042 that are movable relative to the implant guide sleeve 3040. For example, the first and second drill guide sleeves 3041, 3042 can be movably coupled to the implant guide sleeve 3040 such that the first and second drill guide sleeves 3041, 3042 are movable in the direction 3092 relative to the handle 3004. As mentioned above, the drill guide 3040 can be movable in the direction 3092 relative to the implant guide sleeve 3000 (e.g., relative to the handle 3004) between a retracted position 3070 (e.g., shown in FIGS. 12A, 12D ) and an extended position 3071 (e.g., shown in FIG. 12B ). In the retracted position 3070, each of the first drill guide sleeve 3041 and the second drill guide sleeve 3042 can be retracted, such as retracted outside the interior region 3006, relative to the implant guide sleeve 3000 (e.g., relative to the handle 3004). To assist in effecting the movement of the drill guide 3040, the implant guide sleeve 3000 can include an actuator 3080, as described herein.

[0175] As shown for the illustrated embodiment, the drill guide 3040 can further include a visual marker 3082. The visual marker 3082 can be configured, for example, to facilitate aiding alignment with the target anatomical structure. As one such example, the visual marker 3082 can be configured to facilitate aiding alignment with a separation between bones. The visual marker 3082 can be movable with the drill guide 3040, such that in the retracted position of the drill guide, the visual marker 3082 can be retracted relative to the implant guide sleeve 3000 and the interior region 3006, while in the extended position of the drill guide, the visual marker 3082 can extend outward relative to the handle 3004 and be aligned with the implant guide sleeve 3000 and the interior region 3006.

[0176] In addition to the drill guide 3040 being movable, the first and second guide arms 3060, 3062 of the implant guide sleeve 3000 may be movable, as previously described herein. In one embodiment, the first guide arm 3060 and the second guide arm 3062 may be movably coupled to the implant guide sleeve 3000 such that they are independently movable relative to the handle 3004, while in another embodiment, the first guide arm 3060 and the second guide arm 3062 are movably coupled to the implant guide sleeve 3000 such that they are simultaneously movable relative to the handle 3004.

[0177] 12D shows an exemplary embodiment of the movable coupling of the first and second guide arms 3060, 3062 on the implant guide sleeve 3000. The first guide arm 3060 can be movably coupled to the implant guide sleeve 3000 via a first pivot coupling 3095, and the second guide arm 3062 can be movably coupled to the implant guide sleeve 3000 via a second pivot coupling 3096. Although FIG. 12D shows a pivotable, pinned coupling of each of the guide arms 3060, 3062 on the handle 3004, other embodiments within the scope of the present disclosure can include other types of movable couplings between the guide arms 3060, 3062 and the implant guide sleeve 3000.

[0178] In the illustrated embodiment, the guide arms 3060, 3062 can be configured to move (e.g., rotate relative to the handle 3004) as a result of movement of the drill guide 3040. In the illustrated embodiment, the drill guide 3040 includes a first guide arm track 3097 and a second guide arm track 3098. Each of the first and second guide arm tracks 3097, 3098 can be defined along multiple axes. For example, the first guide arm track 3097 can include a first guide arm track first portion 3097a extending along a first axis and a first guide arm track second portion 3098b extending along a second axis different from the first axis, and the second guide arm track 3098 can include a second guide arm track first portion 3098a extending along a third axis (e.g., the third axis is parallel to the first axis and oblique to the second axis) and a second guide arm track second portion 3098b extending along a fourth axis different from the third axis (e.g., the fourth axis is parallel to the second axis and oblique to the first axis). In the embodiment shown here, the first guide arm track 3097 and the second guide arm track 3098 are mirror images of each other. The first and second guide arm tracks 3097, 3098 are positioned between the proximal end 3091 and the distal end 3090, and may be positioned proximal to the drill guide sleeves 3041, 3042, for example.

[0179] As the drill guide 3040 moves in the direction 3092, the first and second guide arm tracks 3097, 3098 can be configured to transfer power from the drill guide 3040 to the guide arms 3060, 3062. For example, the first pivot coupling 3095 of the first guide arm 3060 can intersect with the first guide arm track 3097, and the second pivot coupling 3096 can intersect with the second guide arm track 3098. Thus, as the drill guide 3040 moves in the direction 3092, the first guide arm track 3097 moves relative to the first pivot coupling 3095, and the second guide arm track 3098 moves relative to the second pivot coupling 3096. This relative movement between the respective tracks 3097, 3098 and pivot couplings 3095, 3096 can act to move the first guide arm 3060 in direction 3086 and the second guide arm 3062 in direction 3087. Thus, movement of the drill guide 3040 in direction 3092 can cause the first and second guide arms 3060, 3062 to move in directions 3086, 3087, respectively. In this manner, movement of the guide arms 3060, 3062 can change the size of the interior region 3006 that receives the drill guide sleeves 3041, 3042 as the drill guide sleeves are moved to the extended position. This allows the interior region 3006 to automatically adjust to the extent necessary to accommodate the drill guide sleeves 3041, 3042.

[0180] Figures 12E-12G illustrate another embodiment of an implant guide sleeve 3100. The implant guide sleeve 3100 can be similar to or the same as the implant guide sleeve 3000 disclosed with respect to Figures 12A-12D. In one example, the implant guide sleeve 3100 can be the same as the implant guide sleeve 3000 described with reference to Figures 12A-12D, except as otherwise specified herein with respect to Figures 12E-12G. Figure 12E illustrates a top view of the implant guide sleeve 3100 in a first size configuration, while Figures 12F and 12G illustrate a top view and a perspective view, respectively, of the implant guide sleeve 3100 in a second size configuration.

[0181] The implant guide sleeve 3100 can define an interior region 3006 between the first guide arm 3060 and the second guide arm 3062. Additionally, at least one of the first and second arms 3060, 3062 (e.g., each of the first and second arms 3060, 3062) can be movable to vary the size of the interior region 3006. For example, each of the first arm 3060 and the second arm 3062 can be movable between a first sized configuration position, an example of which is shown in FIG. 12E, and a second sized configuration position, an example of which is shown in FIG. 12F. By moving the first arm 3060 and the second arm 3062, the interior region 3006 can be adjusted, for example, between a smaller interior region 3006 when the first and second arms 3060, 3062 are in a first size configuration position of FIG. 12E and a larger interior region 3006 when the first and second arms 3060, 3062 are in a second size configuration position of FIG. 12F.

[0182] The illustrated embodiment of the implant guide sleeve 3100 can be configured such that movement of the handle 3044 of the drill guide 3040 moves each of the first and second arms 3060, 3062, and therefore changes the size of the interior region 3006. In particular, the implant guide sleeve 3100 can be configured such that sliding the handle 3044 relative to the handle 3004 results in movement of each of the first and second arms 3060, 3062, and changes the size of the interior region 3006. For example, the handle 3044 of the drill guide 3040 can be slidable in a direction 3092 relative to the handle 3044, and thus relative to the arms 3060, 3062, between a retracted position 3070, as illustrated in FIG. 12E , and an extended position 3071, as illustrated in FIGS. 12F and 12G . The handle 3044 of the drill guide 3040 can generally cover the handle 3004. In the illustrated embodiment, when the implant guide sleeve 3100 is positioned on one or more bone portions, the handle 3004 can face the bone or bones on which the implant guide sleeve 3100 is positioned, while the handle 3044 can overlap the handle 3004 and thus face away from the bone or bones on which the implant guide sleeve 3100 is positioned. As such, the sliding handle 3044 can face away from the bone or bones and generally cover the handle 3004 (e.g., cover a majority of the surface area of ​​the handle 3004 on the side of the handle 3004 that interfaces with the handle 3044). This can be useful to help prevent objects (e.g., gloves worn by a user) from getting caught or entangled on the fixed handle 3004 and / or between the movable handle 3044 and the fixed handle 3004.

[0183] In one particular such embodiment, the handle 3044 may be coupled to a biasing member, such as a spring, configured to bias the handle 3044 in one of the retracted position 3070 and the extended position 3071. And, when that bias on the handle 3044 is overcome, the handle 3044 may move, for example, as a result of a user-applied force and / or a plunger member acting on the handle 3044, such that the handle 3044 can move from a biased position of one of the retracted position 3070 and the extended position 3071 to the other of the retracted position 3070 and the extended position 3071. In such an example, the handle 3044 may be stationary and include a first detent member and a second detent member, the first detent member associated with the retracted position 3070 of the handle 3044 and the second detent member associated with the extended position 3071 of the handle 3044. In this example, overcoming the bias on the handle 3044 causes the handle 3044 to move the plunger out of engagement with the first detent member and into engagement with the second detection member, thereby moving the handle 3044, and therefore the drill guide 3040, from the retracted position 3070 and the extended position 3071, which in turn may move the arms 3060, 3062 and expand the interior region 3006.

[0184] The illustrated embodiment of the implant guide sleeve 3100 can include a first guide arm 3060 and a second guide arm 3062, the size of which can approximate (e.g., equal to) the size of the drill guide 2040 when the arms 3060, 3062 are in the second size configuration. For example, the drill guide 2040 can define a drill guide envelope in the area where the drill guide is positioned in one or more bone portions, and the arms 3060, 3062 can define a guide sleeve arm envelope 3110 when the arms 3060, 3062 are in the second size configuration (e.g., defining a relatively larger interior area 3006 compared to the interior area associated with the first size configuration and when the drill guide is in the extended position 3071). In certain embodiments, the guide sleeve arm envelope 3110 can approximate (e.g., equal to) the drill guide envelope. In one application, the guide sleeve arm envelope 3110 can be sized to fit through (e.g., partially through) a 1.75 cm, 2.0 cm, or 2.25 cm incision. To assist in defining this guide sleeve arm envelope 3110, the arms 3060, 3062 of the implant guide sleeve 3100 can have a reduced wall thickness compared to the wall thickness of the arms 3060, 3062 of the implant guide sleeve 3000.

[0185] 12H-12I show the implant guide sleeve 3100 of Figures 12E-12G, but with a modified guide sleeve profile to help minimize the size of the incision required, for example, when using the implant guide sleeve 3100. Figure 12H is a bottom view of the bone-facing side of the implant guide sleeve 3100 in a second size configuration, and Figure 121 is a perspective view of the bone-facing side of the implant guide sleeve 3100 in the second size configuration.

[0186] The implant guide sleeve 3100 shown in Figures 12H and 12I can have a modified guide sleeve contour relative to the guide sleeve contour shown in Figures 12E-12G. The implant guide sleeve 3000 can include, for example, a first end undersurface 3020, a second end undersurface 3021, a first end upper surface 3022, and a second end upper surface 3023, for example, on the body 3002. The first end undersurface 3020 can be a bone-facing surface that defines the bone-facing end of the first guide arm 3060, and the first end undersurface 3022 can be on the opposite side of the first guide arm 3060 from the first end undersurface 3020. The first guide arm 3060 can also include a first pin opening 3026. Similarly, the second end undersurface 3021 can be a bone-facing surface that defines the bone-facing end of the second guide arm 3062, and the second end undersurface 3023 can face the opposite side of the second guide arm 3062 from the second end undersurface 3021. The second guide arm 3062 can also include a second pin opening 3028. As will be further described, the implant guide sleeve 3100 shown in FIGS. 12H and 12I can have a modified guide sleeve geometry on the first guide arm 3060 and / or the second guide arm 3062.

[0187] 12H and 12I, the implant guide sleeve 3100 can have a modified guide sleeve profile in the first guide arm 3060 and / or the second guide arm 3062, which may help, for example, minimize the size of the incision required when using the implant guide sleeve 3100. As an example, the first pin opening 3026 in the first guide arm 3060 can have a reduced profile (e.g., reduced width) at or near the bone-facing portion of the first guide arm 3060. The illustrated example of FIGS. 12H-12I shows that the first pin opening 3026 can have a bone-facing portion 3026c that has a smaller width than an upper portion 3026d opposite the first pin opening 3026. In particular, this example depicts the bone-facing portion 3026c of the first pin opening 3026 as a partially open channel, e.g., in the form of a semicircular open channel, while the opposite, upper portion 3026d of the first pin opening 3026 is a sealed circular channel having a wider width than the bone-facing portion 3026c of the first pin opening 3026. Thus, the first pin opening 3026 can define a sealed channel extending from the upper portion 3026d of the first pin opening 3026 and an open channel extending from the bone-facing portion 3026c of the first pin opening 3026. The first pin opening 3026 can have a channel transition 3026a where the first pin opening 3026 transitions between two different widths defined by the first pin opening 3026, such that a larger width (e.g., closed) portion of the first pin opening 3026 extends from the upper portion 3026d to the channel transition 3026a, and a smaller width (e.g., open) portion of the first pin opening 3026 extends from the channel transition 3026a to the bone-facing end 3026b of the first pin opening 3026. Similarly, the second pin opening 3028 in the second guide arm 3062 can have a reduced profile (e.g., reduced width) at or near the bone-facing portion of the second guide arm 3062. The illustrated example of FIGS. 12H-12I shows that the second pin opening 302 can have a bone-facing portion 3028c that has a smaller width than an opposite, upper portion 3028d of the second pin opening 3028.In particular, in this example, the bone-facing portion 3028c of the second pin opening 3028 is shown as a partially open channel, e.g., in the form of a semicircular open channel, while the opposite, upper portion 3028d of the second pin opening is a sealed circular channel having a wider width than the bone-facing portion 3028c of the second pin opening 3028. Thus, the second pin opening 3028 can define a sealed channel extending from the upper portion 3028d of the second pin opening 3028 and an open channel extending from the bone-facing portion 3028c of the second pin opening 3028. The second pin opening 3028 can have a channel transition 3028a, where the second pin opening 3028 transitions between two different widths defined by the second pin opening 3028, such that a larger-width (e.g., closed) portion of the second pin opening 3028 extends from the upper portion 3028d to the channel transition 3028a, and a smaller-width (e.g., open) portion of the second pin opening 3028 extends from the channel transition 3028a to the bone-facing end 3028b of the second pin opening 3028. The smaller-width portions 3026c, 3028c of the respective first and second pin openings 3026, 2028 may face away from the interior region 3006 and thus may be at the outer circumferential surface of the implant guide sleeve 3100. This may therefore help to reduce the size of the incision required for the implant guide sleeve 3100 to access the bone through the incision.

[0188] 12H and 12I, the implant guide sleeve 3100 can have a modified guide sleeve profile at the first guide arm 3060 and / or the second guide arm 3062 in the form of a reduced width at one or more bone-facing portions of the first guide arm 3060 and / or the second guide arm 3062. For example, the first guide arm 3060 can have a bone-facing portion of reduced width extending from the first end lower surface 3020 to a first guide width transition portion 3060a. The first guide width transition portion 3060a can be at the same height along the implant guide sleeve 3100 as the channel transition portion 3026a, such that the channel transition portion 3026a and the first guide width transition portion 3060a are coplanar. Similarly, the second guide arm 3062 can have a bone-facing portion of reduced width extending from the second end undersurface 3021 to a second guide width transition portion 3062a. The second guide width transition portion 3062a can be at the same height as the channel transition portion 3028a along the implant guide sleeve 3100, such that the channel transition portion 3028a and the second guide width transition portion 3062a are coplanar. In a further example, the channel transition portion 3026a and the first guide width transition portion 3060a of the first guide arm 3060 can be at the same height as the channel transition portion 3028a and the second guide width transition portion 3062a of the second guide arm 3062, such that the channel transition portion 3026a, the first guide width transition portion 3060a, the channel transition portion 3028a, and the second guide width transition portion 3062a are coplanar. The smaller width portion of each first and second guide arm 3026, 3028 may face away from the interior region 3006 and thus may be at the outer periphery of the implant guide sleeve 3100. This may therefore help to reduce the size of the incision required for the implant guide sleeve 3100 to access the bone through the incision.

[0189] The foregoing disclosure and accompanying figures include descriptions of the use of an implant guide sleeve to guide the creation of one or more implant holes and / or to guide the placement of an implant. As noted, staple 500 can be one exemplary type of such implant that is guided for placement using an implant guide sleeve. The following disclosure regarding FIGS. 13 and 14 describes aspects related to the implant after it has been positioned in the target anatomy, according to various embodiments. FIG. 13 also specifically illustrates staple 500, although other embodiments within the scope of this disclosure can include other staple configurations and / or other types of implants (e.g., bone plates, etc.).

[0190] Figure 13 is a side view of staple 500 operably coupled to assembled inserter 1100 after staple 500 has been positioned against first bone 1604 and second bone 1606. As one such example, Figure 13 can represent a point in time after staple 500 has been so positioned using an implant guide sleeve to guide such positioning, and the implant guide sleeve has been removed, leaving staple 500 and operably connected inserter 1100 previously guided through the interior region of the implant guide sleeve.

[0191] 13 shows the staple 500 positioned in contact with a first bone 1604 and a second bone 1606, with the bridge 506 of the staple 500 bridging across the separation 1602 between the bones 1604, 1606. As also shown here, this can further include a first leg 502 positioned in a first implant hole 2034 in the first bone 1604 and a second leg 504 positioned in a second implant hole 2036 in the second bone 1606. This positioning of the staple 500 can also include contacting the first bone 1604 and the second bone 1606 with an underside 528 of the staple 500. In one particular such example, contacting the first bone 1604 and the second bone 1606 with the lower surface 528 of the staple 500 can include contacting the first bone 1604 generally flush with the lower surface 528 and contacting the second bone 1606 generally flush with the lower surface 528.

[0192] When the staple 500 is so positioned, the connector 1106 of the inserter 1100 can receive the first coupling shaft 1102 (e.g., in a first receptacle 1114 of the connector 1106) and the second coupling shaft 1104 (e.g., in a second receptacle 1116 of the connector 1106). When the first and second coupling shafts 1102, 1104 are received in the connector 1106, the staple 500 can be in a deformed, inserted state as shown in FIG. 13. As can be seen from the depicted example, the deformed, inserted state of the staple 500, when the connector 1106 is coupled with the first coupling shaft 1102 and the second coupling shaft 1104, the first leg 502 can be substantially parallel to the second leg 504. This generally parallel configuration of the legs 502, 504 may help to facilitate insertion of the legs 502, 504 in the respective bones 1604, 1606 (eg, in the respective implant holes 2034, 2036).

[0193] Once the staple 500 is positioned as desired in the target anatomical structure, the staple 500 can be configured to apply a compressive force to the target anatomical structure. Figure 14 is a side view of the inserter 1100 of Figure 13, but with the connector 1106 removed. In such embodiments, removing the connector 1106 can transition the staple 500 from the deformed insertion state to a biased, compression-induced state. The biased, compression-induced state can cause the staple 500 to apply one or more compressive forces to one or more bones 1604, 1606.

[0194] Removing the connector 1106 from the inserter 1100 can remove the loading force previously applied by the connector 1106 from the staple 500. Removing the connector 1106 can cause the first coupling shaft 1102 and the second coupling shaft 1104 to move away from one another—the first coupling shaft 1102 can move in direction 1906 (e.g., the opposite direction from the direction the first coupling shaft 1102 moves when the connector 1106 joins the first coupling shaft 1102 to the second coupling shaft 1104) and the second coupling shaft 1104 can move in direction 1908 (e.g., the opposite direction from the direction the second coupling shaft 1104 moves when the connector 1106 joins the second coupling shaft 1104 to the first coupling shaft 1102). In a further 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 operative coupling to the staple 500 .

[0195] 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 one another (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) prior to removing the connector 1106, 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 one another can help disengage the first retention feature, if included in the first coupling shaft 1102, from the first receptacle 1114 and the second retention feature, if included in the second coupling shaft 1104, from the second receptacle 1116.

[0196] When the connector 1106 is removed from the first coupling shaft 1102 and the second coupling shaft 1104 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 their natural biased, compression-induced state, as shown in the example of FIG. 14 . This can include a state in which the first leg 502 and the second leg 504 are generally obliquely positioned such that the central longitudinal axis of the leg 502 intersects the central longitudinal axis of the leg 504. Furthermore, because the connector 1106 is in the process of being removed from the first coupling shaft 1102 and the second coupling shaft 1104 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 legs 502, 504 of staple 500 to return from their deformed position to their original 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 compressive force being applied by the staple across the entire end face of the bone.

[0197] In some embodiments, multiple implants can be positioned in accordance with the teachings disclosed herein. For example, in one embodiment, at least two staples (e.g., two staples 500) can be positioned in and across bones 1604, 1606 in accordance with the teachings disclosed herein. This can include, for example, positioning 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 positioning at least two such staples in and across the bones 1604, 1606 in accordance with the teachings disclosed herein, related techniques may further include making a first incision in a first anatomical location (e.g., the medial cuneiform, adjacent to the first metatarsal and crossing the TMT joint dorsally) and making a second, different anatomical location (e.g., the medial cuneiform, adjacent to the first metatarsal and crossing the TMT joint medially) prior to positioning such staples in the bones 1604, 1606.

[0198] 15A-15C illustrate an embodiment of a contour guide 4000. FIG. 15A is a perspective view of the contour guide 4000 and an optional accompanying implant guide sleeve 4002, FIG. 15B is an elevation view of the contour guide 4000 positioned on the implant guide sleeve 4002 to modify the surface of one or more bone portions 1604, 1606, and FIG. 15C is a perspective view of the contour guide 4000 positioned on a different implant guide sleeve 3000. As will be described further, the contour guide 4000 can be configured to facilitate one or more surface modifications to one or more bone portions 1604, 1606. Use of the contour guide 4000 to create such one or more surface modifications can be useful, for example, in creating a suitable modified bone surface upon which an implant can be positioned (e.g., then secured when so positioned at least on the modified bone surface). In one example, the contour guide 4000 can be configured to guide such modification of one or more bone surfaces in one or more surface areas of one or more bone portions 1604, 1606 that will contact an implant to be placed therein.

[0199] The contour guide 4000 includes a contour guide body 4004. The body 4004 has an upper side 4005 and a lower side 4007 opposite the upper side 4005. The lower side 4007 can be configured to interface with one or more bones 1604, 1606. For example, the lower side 4007 can be configured to at least partially contact one or more bones 1604, 1606. In some such examples, as shown in FIG. 15B , the lower side 4007 can be configured to interface with the first bone 1604, the second bone 1606, and the separation 1602 between the first bone 1604 and the second bone 1606. In one particular such example, the underside 4007 can be configured to contact at least a portion of a surface, such as a dorsal surface, medial surface, or lateral surface, of the first bone 1604, and can also be configured to contact at least a portion of a surface, such as a dorsal surface, medial surface, or lateral surface, of the second bone 1606 while the underside bridges across the separation portion 1602.

[0200] The contour guide 4000 can include a guide slot 4010. The guide slot 4010 can define an opening in a portion of the body 4004 configured to interface with one or more bones 1604, 1606. As shown for the illustrated embodiment of the contour guide 4000, the guide slot 4010 can be included on or near the underside 4007 of the body 4004 (e.g., opposite the upper side 4005), such that the guide slot 4010 is configured to interface with one or more bone surfaces to be modified in the one or more bones 1604, 1606 using the contour guide 4000. The guide slot 4010 can define a guide slot cross-sectional area 4012 (e.g., the cross-sectional area of ​​the opening defined by the guide slot 4010 at or near the underside 4007). The guide slot cross-sectional area 4012 can be defined by a plane in the guide slot that extends transversely to a plane extending between the upper side 4005 and the lower side 4007. The guide slot cross-sectional area 4012 can be configured to receive one or more bone surface modifying instruments 4013 to modify one or more surface areas 1615 of at least one of the first bone 1604 and the second bone 1606 to form modified surface areas 4011 on one or both of the first bone 1604 and the second bone 1606. For example, the guide slot 4010 may be configured to receive one or more bone surface modifying instruments 4013 such that the one or more bone surface modifying instruments 4013 are positioned within the guide slot 4010 (e.g., extending out from the underside 4007 of the body 4004) and contact one or more surface regions 1615 of at least one of the first bone 1604 and the second bone 1606, such that the one or more bone surface modifying instruments 4013 within the guide slot 4010 can form modified surface regions 4011. The illustrated embodiment shows an example of a guide slot 4010 configured to receive two or more bone surface modifying instruments 4013 therein.

[0201] The contour guide 4000 can be configured to facilitate modifying one or more surface areas 1615 in one or more bones 1604, 1606 along a surface dimension (e.g., length and / or width) of the one or more bones 1604, 1606 on which an implant will be placed. To do so, the guide slot 4010 can, for example, define a cross-sectional area 4012 of the guide slot opening that thus corresponds to the cross-sectional area of ​​an implant (e.g., staple, plate) that will be placed on the one or more bone portions 1604, 1606 after the contour guide 4000 is used to create the modified surface area 4011 on the one or more bone portions 1604, 1606. For example, when the body 4004 is placed in one or more bone portions 1604, 1606 (e.g., with the underside 4007 positioned against the one or more bone portions 1604, 1606), the guide slot 4010 can be configured to approximate a surface area (e.g., length and / or width) of the one or more bone portions 1604, 1606 into which an implant will later be placed. Thus, the guide slot 4010 can be configured to define a bone surface modification area via the cross-sectional area 4012 that corresponds to the size of an implant that will later be placed in the same bone surface modification area defined by the cross-sectional area 4012 of the guide slot 4010.

[0202] In some such examples, the cross-sectional area 4012 of the guide slot 4010 may correspond to the size of an implant that will be subsequently placed in the same bone surface modification region defined by the cross-sectional area 4012, with the cross-sectional area 4012 being equal to or greater than the cross-sectional area of ​​the implant (e.g., staple, plate, etc.) that will subsequently be placed in the bone surface modification region defined by the cross-sectional area 4012. This may help to facilitate the creation of a modified surface region 4011 that has a length and / or width that is at least equal to the length and / or width of the implant that will subsequently be placed in the bone surface modification region defined by the cross-sectional area 4012. In other such examples, the cross-sectional area 4012 of the guide slot 4010 may be smaller than the cross-sectional area of ​​the implant (e.g., staple, plate, etc.) that will subsequently be placed in the bone surface modification region defined by the cross-sectional area 4012. Depending on the type and configuration of the implant to be placed in various applications, this may be useful to facilitate the creation of a modified surface area 4011 that is smaller than the length and / or width of the implant to be subsequently placed, for example, in applications where it is desired to modify only a portion of the surface area of ​​the bone into which the implant is to be placed.

[0203] In some embodiments, the contour guide 4000 can further include at least one guide opening 4008. The at least one guide opening 4008 can be configured to at least partially receive one or more bone surface modifying instruments 4013. The at least one guide opening 4008 can extend through at least a portion of the body 4004. For example, the at least one guide opening 4008 can extend through at least a portion of the body from the upper side 4005 toward the lower side 4007. The at least one guide opening 4008 can be axially aligned with the guide slot 4010, such that when the at least one guide opening 4008 receives the bone surface modifying instrument 4013, the bone surface modifying instrument 4013 can be axially aligned with the guide slot 4010. Thus, as a result of the axial alignment between at least one guide opening 4008 and the guide slot 4010, when the bone surface modification instrument 4013 is positioned within the guide opening 4008, the bone surface modification instrument 4013 can be guided within the guide slot 4010 (e.g., while the bone surface modification instrument 4013 is also within the guide opening 4008).

[0204] As an example, the illustrated embodiment of the contour guide 4000 includes a plurality of guide openings 4008, each configured to receive a bone surface modifying instrument 4013 therein. The plurality of guide openings 4008 shown for the illustrated example may extend from the upper side 4005 toward the lower side 4007, but may terminate before the lower side 4007 and before the guide slot 4010. The illustrated embodiment of the contour guide 4000 includes a first guide opening 4008a, a second guide opening 4008b, a third guide opening 4008c, and a fourth guide opening 4008d, each configured to receive a respective bone surface modifying instrument 4013. In this example, the first, second, third, and fourth guide openings 4008a-4008d are separate openings spaced apart from one another and defined in the body 4004. In some examples, the guide openings 4008a-4008d may extend through the body 4004 from the upper side 4005 and may define parallel guide openings 4008a-4008d extending through the body 4004 from the upper side 4005 towards the lower side 4007. In other examples, the guide openings 4008a-4008d may extend through the body 4004 from the upper side 4005 and may define at least pairs of non-parallel guide openings 4008a-4008d extending through the body 4004 from the upper side 4005 towards the lower side 4007.

[0205] As one example of at least one pair of non-parallel guide openings 4008a-4008d, one or more of the guide openings 4008a-4008d can extend through the body 4004 in a first directional orientation from the upper side 4005 toward the lower side 4007, and one or more others of the guide openings 4008a-4008d can extend through the body 4004 in a second, different directional orientation that is non-parallel to the first directional orientation from the upper side 4005 toward the lower side 4007. As one such example, one or more of the guide openings 4008a-4008d can extend through the body 4004 in a first oblique direction from the upper side 4005 toward the lower side 4007, and one or more others of the guide openings 4008a-4008d can extend through the body 4004 in a second, different oblique direction from the upper side 4005 toward the lower side 4007. With reference to the illustrated embodiment, one or both of guide openings 4008a, 4008b can extend through body 4004 in a first oblique direction from top side 4005 toward bottom side 4007, while one or both of guide openings 4008c, 4008d can extend through body 4004 in a second, different oblique direction from top side 4005 toward bottom side 4007. For example, guide openings 4008a and / or 4008b can define an oblique opening through body 4004 in a direction toward guide openings 4008c and / or 4008d, and guide openings 4008c and / or 4008d can define an oblique opening through body 4004 in a direction toward guide openings 4008a and / or 4008b. Each of the plurality of guide openings 4008 can be defined by the body 4004 as a separate opening that opens at the upper side 4005 of the body 4004 and extends through at least a portion of the body 4004 toward the lower side 4007.

[0206] The cross-sectional area 4009 of the one or more guide openings 4008 and the cross-sectional area 4012 of the guide slot 4010 can each be configured to receive a bone surface modifying instrument 4013. The cross-sectional area 4012 of the guide slot 4010 can be equal to or greater than the cross-sectional area 4009 of the one or more guide openings 4008. The cross-sectional area 4009 of the one or more guide openings 4008 can be defined in a plane at the one or more guide openings 4008 that extends transversely to a plane extending between the upper side 4005 and the lower side 4007. For example, the guide slot 4010 can define its opening to have a cross-sectional area 4012 that is greater than the cross-sectional area 4009 of any one of the plurality of guide openings 4008. As another example, the guide slot 4010 can define its opening to have a cross-sectional area 4012 that is greater than the combined cross-sectional area 4009 defined by each of the plurality of guide openings 4008.

[0207] As mentioned above, the contour guide 4000 can be configured to receive a bone surface modifying instrument 4013 therein (e.g., via one or more guide openings 4008 and / or guide slots 4010). The bone surface modifying instrument 4013 received in the contour guide 4000 can be configured to remove at least a portion of the surface 1615 in one or more bones 1604, 1606. For example, the bone surface modifying instrument 4013 received in the contour guide 4000 can be configured to fracture or otherwise modify (e.g., smooth the bone surface) the surface 1615 of one or more bones 1604, 1606, thereby creating a modified surface region 4011. The illustrated embodiment shows one or more burr instruments as examples of the types of bone surface modifying instruments 4013 that can be received in and guided by the guide openings 4008. However, other types of bone surface modifying instruments 4013 can be used, including saws, etc., configured to fracture or otherwise modify bone surfaces.

[0208] In some embodiments, such as the one shown here, the contour guide 4000 can include a handle 4006. The handle 4006 can extend from the body 4004 to provide a user with an interface for manipulating the body 4004 of the contour guide 4000 and positioning it against one or more bones 1604, 1606. However, in other embodiments, the contour guide 4000 may not include any handle.

[0209] In embodiments including an implant guide sleeve with the contour guide 4000, the system 4050 can include the contour guide 4000 and the implant guide sleeve (e.g., implant guide sleeve 4002, implant guide sleeve 3000). In other embodiments, the contour guide 4000 can be used to modify one or more bone surfaces without an associated guide sleeve, as described herein.

[0210] The implant guide sleeve 4002 can be similar to or the same as the implant guide sleeve 2000 disclosed elsewhere herein. In particular, as described elsewhere herein, the implant guide sleeve 4002 can be configured to be placed on one or more bone portions 1604, 1606 (e.g., two separate bones, such as in the foot, two portions of the same bone, such as in the foot) to guide the creation of an implant hole in such one or more bones and / or to guide the placement of an implant, such as a staple, in one or more bone portions 1604, 1606. Thus, positioning the contour guide 4000 relative to the implant guide sleeve 4002 can guide the placement of the contour guide 4000 in the one or more bone portions 1604, 1606 at a location on the one or more bone portions 1604, 1606 that corresponds to the location of the intended implant.

[0211] In some examples, to help facilitate reception of the contour guide 4000 in the implant guide sleeve 4002, the implant guide sleeve 4002 can define an interior cross-sectional area 4003 configured to accommodate and guide placement of the contour guide 4000 in one or more of the bones 1604, 1606. For example, the interior cross-sectional area 4003 in the guide sleeve 4002 can be configured to receive and guide placement of at least the underside 4007 of the contour guide body 4004, such that it abuts the first bone 1604, the second bone 1606, and the separation 1603 between the first and second bones 604, 1606. The interior cross-sectional area 4003 in the guide sleeve 4002 can be larger than the cross-sectional area 4012 of the guide slot 4010 in the contour guide 4000, such that the interior cross-sectional area 4003 in the guide sleeve 4002 is configured to receive at least the guide slot 4010. The interior cross-sectional area 4003 of the guide sleeve 4002 can be defined, for example, by a plane on the implant guide sleeve 4002 that extends transversely to a plane extending between the upper side 4005 and the lower side 4007 .

[0212] In addition to receiving and guiding the guide slots 4010, the interior cross-sectional area 4003 of the implant guide sleeve 4002 may be configured to guide the creation of one or more implant holes in one or more bones 1604, 1606 and / or to guide the placement of one or more implants in one or more bones 1604, 1606, e.g., as described elsewhere herein. For example, the interior cross-sectional area 4003 of the implant guide sleeve 4002 may be configured to guide the creation of a first implant hole in the modified surface area 4011 of the bone 1604 and the creation of a second implant hole in the modified surface area 4011 of the bone 1606. As another additional or alternative example, the interior cross-sectional area 4003 of the implant guide sleeve 4002 may be configured to guide the placement of a first leg of an implant (e.g., a staple) in the first implant hole in the modified surface area 4011 of the bone 1604 and the placement of a second leg of an implant in the second implant hole in the modified surface area 4011 of the bone 1606. Thus, as one such specific example, the internal cross-sectional area 4003 of the implant guide sleeve 4002 may be configured for both (i) guiding the creation of a first implant hole in the modified surface area 4011 of the bone 1604 and the creation of a second implant hole in the modified surface area 4011 of the bone 1606, and (ii) guiding the placement of a first leg of an implant (e.g., a staple) in the first implant hole in the modified surface area 4011 of the bone 1604 and the placement of a second leg of the implant in the second implant hole in the modified surface area 4011 of the bone 1606.

[0213] 15C is a perspective view of the contour guide 4000 positioned in a different implant guide sleeve 3000. The positioning and use of the contour guide 4000 in combination with the implant guide sleeve 3000 can be similar to that described with respect to the implant guide sleeve 4002. Additionally, the implant guide sleeve 3000 can define an interior cross-sectional area that is the same as or similar to the interior cross-sectional area 4003 of the guide sleeve 4002 described above. Accordingly, the interior cross-sectional area of ​​the implant guide sleeve 3000 can be configured to receive at least the guide slot 4010 therein and guide the positioning of at least the guide slot 4010 of the contour guide 4000 in one or more of the bones 1604, 1606.

[0214] As mentioned, and as further described herein, the contour guide 4000 may be used in a manner to make one or more surface modifications to one or more bones 1604, 1606 (e.g., one or more bone portions 1604, 1606 of the same bone, or one or more different bones 1604, 1606).

[0215] 15D is a flow diagram of an exemplary surgical technique 2500 for modifying a bone surface to receive an implant using a contour guide. In some embodiments, technique 2500 may include modifying such bone surface(s) to receive an implant (e.g., staple, plate, etc.) using a contour guide 4000, as described elsewhere herein.

[0216] In some embodiments, technique 2500 can include the use of an implant guide sleeve. In those embodiments of technique 2500 that include the use of an implant guide sleeve, technique 2500 can include the optional step 2505 of positioning the implant guide sleeve.

[0217] At step 2505, the technique may include positioning an implant guide sleeve. The implant guide sleeve may be positioned at one or more bone locations. For example, referring to the example of FIG. 15B , implant guide sleeve 4004 may be positioned at first bone 1604 and second bone 1606, and across separation 1602 between first bone 1604 and second bone 1606. The guide sleeve positioned at one or more bones at step 2505 may be the same as or similar to, for example, any one of the implant guide sleeve embodiments disclosed elsewhere herein (e.g., implant guide sleeve 4002, implant guide sleeve 3000).

[0218] As described above, the implant guide sleeve positioned on one or more bones can be used to guide the placement of one or more tools. For example, as described above, the implant guide sleeve positioned on one or more bones can be used to guide the placement of the contour guide 4000, to guide the creation of one or more implant holes in one or more bones (e.g., the modified surface region 4011 of the bone 1604 that was modified using the contour guide 4000), and / or to guide the placement of an implant in one or more implant holes (e.g., placing a first leg of a staple in a first implant hole in the modified surface region 4011 of the bone 1604 and placing a second leg of a staple in a second implant hole in the modified surface region 4011 of the bone 1606). In instances where an implant guide sleeve is used and positioned in step 2505, the implant guide sleeve can be secured in one or more bones (e.g., securing the implant guide sleeve to the implant guide sleeve and one or more bones using one or more wires or pins) before positioning the contour guide 4000 relative to the implant guide sleeve. As one particular such example, the implant guide sleeve can be secured to the first bone 1604 and the second bone 1606 before using the implant guide sleeve to position the contour guide at the first bone 1604 and the second bone 1606 and across the separation 1602 between the first bone 1604 and the second bone 1606.

[0219] Other embodiments of the technique 2500 may not use an implant guide sleeve, and in those embodiments, the technique 2500 may be performed without the step 2505 of positioning an implant guide sleeve.

[0220] At step 2510, technique 2500 may include positioning contour guide 4000 in contact with one or more bones. For example, referring to the example of FIG. 15B , contour guide 4000 may be positioned across first bone 1604 and second bone 1606 and separation 1602 between first bone 1604 and second bone 1606. For example, contour guide 4000 may be so positioned by positioning underside 4007 of contour guide 4000 against first bone 1604 and second bone 1604 and across separation 1602 between first bone 1604 and second bone 1606. In one such example, the contour guide 4000 can be so positioned by positioning the guide slot 4010 of the contour guide 4000 over at least a portion of the first bone 1604 and over at least a portion of the second bone 1606, and across the separation 1602 between the first bone 1604 and the second bone 1606.

[0221] In some examples, positioning the contour guide 4000 in contact with one or more bones 1604, 1606 in step 2510 may include defining a bone surface modification region in the one or more bones 1604, 1606 at least in part via the contour guide 4000. The bone surface modification region may be a region of the surface 1615 of the one or more bones 1604, 1606 that is modified to create a modified surface region 4011 and receive an implant (e.g., staple, plate, etc.) therein. The bone surface modification region may be defined in whole or in part by a guide slot 4010 in the contour guide 4000 that is positioned in the one or more bones 1604, 1606. Thus, positioning the contour guide 4000 in contact with one or more bones 1604, 1606 in step 2510 may include positioning the guide slot 4010 in contact with at least a portion of a first surface 1615 on the first bone 1604 and at least a portion of a second surface 1615 on the second bone 1606. Additionally, at least a portion of the first surface 1615 on the first bone 1604 and at least a portion of the second surface 1615 on the second bone 1606 that the guide slot 4010 is positioned to contact may define a bone surface modification region in the surface 1615 of the bone 1604, 1606 that is to be modified to create a modified surface region 4011 to receive an implant therein.

[0222] If the technique 2500 includes step 2505 of positioning an implant guide sleeve on one or more bones 1604, 1606, the contour guide 4000 may be positioned on the one or more bones 1604, 1606 using the implant guide sleeve in step 2510. In such an embodiment, the contour guide 4000 may be positioned on the one or more bones 1604, 1606 relative to the implant guide sleeve. In one example, this may include positioning the contour guide 4000 relative to the implant guide sleeve by positioning at least a portion of the body 4004 of the contour guide 4000 within the implant guide sleeve (e.g., positioning at least the guide slot 4010).

[0223] In step 2515, technique 2500 may include modifying a surface region of at least one bone using the contour guide to form a modified surface region on the at least one bone.

[0224] 15B , step 2515 may include using contour guide 4000 to modify a region of surface 1615 of at least one of first bone 1604 and second bone 1606 to form modified surface region 4011 on one or more of first bone 1604 and second bone 1606. In a further such example, with reference to the exemplary application shown in FIG. 15B , step 2515 may include using contour guide 4000 to modify a first region of surface 1615 on first bone 1604 to form modified first surface region 4011 along first bone 1604, and modifying a second region of surface 1615 on second bone 1606 to form modified second surface region 4011 along second bone 1606.

[0225] As previously described herein, the modified surface region 4011 in the first and / or second bone 1604, 1606 may include one or more modifications to the surface 1615 of the first and / or second bone 1604, 1606 at locations along the surface 1615 of the first and / or second bone 1604, 1606 where an implant will be placed after creating the modified surface region 4011. Accordingly, a contour guide may be used to help define a size of the bone surface modification region 4011 that corresponds to the size of an implant to be placed in the bone surface modification region 4011. Because the contour guide 4000 may approximate the size of the implant to be placed (e.g., via the guide slot 4010), using the contour guide 4000 to define the bone surface modification region 4011 where the surface of one or more bones 1604, 1606 is modified may allow for the creation of surface changes in one or more bone portions 1604, 1606 that are compatible with an implant to be placed in the same surface that was modified using the contour guide 4000.

[0226] For example, an implant (e.g., staple, plate, etc.) placed after bone surface modification(s) using the contour guide can have an implant length, and the modified surface area 4011 of the first and / or second bone 1604, 1606 can have a modified surface area that is equal to or greater than the implant length. With reference to the exemplary application shown in FIG. 15B , an implant placed in the first bone 1604, the second bone 1606, and across the separation 1602 between the bones 1604, 1606 can have an implant length (e.g., the staple length), and the modified first surface area 4011 on the first bone 1604 and the modified second surface area 4011 on the second bone 1606 can define a modified bone surface length along the first and second bones 1604, 1606 that is equal to or greater than the implant length (e.g., the staple length).

[0227] In additional or alternative examples, an implant (e.g., staple, plate, etc.) placed after bone surface modification(s) using the contour guide can have a width of the implant, and the modified surface area 4011 on the first and / or second bone 1604, 1606 can have a width of the modified surface area that is equal to or greater than the width of the implant. With reference to the exemplary application shown in FIG. 15B , an implant placed on the first bone 1604, the second bone 1606, and across the separation 1602 between the bones 1604, 1606 can have a width of the implant (e.g., the width of a staple), and the modified first surface area 4011 on the first bone 1604 and the modified second surface area 4011 on the second bone 1606 can define a width of the modified bone surface along the first and second bones 1604, 1606 that is equal to or greater than the width of the implant (e.g., the width of a staple).

[0228] In a further example, an implant (e.g., staple, plate, etc.) placed after bone surface modification(s) using the contour guide can have an implant length and an implant width that defines an implant cross-sectional area, and the modified surface area 4011 in the first and / or second bone 1604, 1606 can have a modified surface area length and a modified surface area width that define a cross-sectional area of ​​the modified surface area that is equal to or greater than the implant cross-sectional area. With reference to the exemplary application shown in FIG. 15B , an implant placed in a first bone 1604, a second bone 1606, and across the separation 1602 between the bones 1604 and 1606 may have an implant length and an implant width that define an implant cross-sectional area, and the modified first surface area 4011 in the first bone 1604 and the modified second surface area 4011 in the second bone 1606 may define a modified bone surface length and a modified bone surface width, and may define a cross-sectional area of ​​the modified surface area along the first and second bones 1604, 1606 that is greater than or equal to the implant cross-sectional area (e.g., greater than or equal to the staple cross-sectional area defined by the staple length and staple width).

[0229] Using the contour guide to create the modified surface region 4011 on one or more of the first and second bones 1604, 1606 may include creating any one or more modifications to the surface 1615 of at least one of the first and second bones 1604, 1606. For example, using the contour guide to create the modified surface region 4011 on one or more of the first and second bones 1604, 1606 may include changing the contour of the surface 1615 of at least one of the first bone 1604 and the second bone 1606. For example, using the contour guide to create the modified surface region 4011 in one or more of the first and second bones 1604, 1606 by modifying the contour at least in the surface 1615 of at least one of the first and second bones 1604, 1606 may include using the contour guide to modify the surface 1615 of at least one of the first and second bones 1604, 1606 such that the surface 1615 of at least one of the first and second bones 1604, 1606 on which the modification is created is flatter than the surface 1615 before the modification. In some applications, this may include using the contour guide to perform a bone surface removal technique to create the modified surface region 4011, such as fracturing the surface 1615 of at least one of the first and second bones 1604, 1606. In some such example applications, creating a modification in the surface 1615 of at least one of the first and second bones 1604, 1606 using the contour guide may include fracturing the bone in the surface 1615 of at least one of the first and second bones 1604, 1606 to create a change in height in the surface 1615 of at least one of the first and second bones 1604, 1606. For example, the modified surface region 4011 in one or more of the first and second bones 1604, 1606 created using the contour guide may be lower in height than the surface 1615 of at least one of the first bone 1604 and the second bone 1606 prior to modification using the contour guide.

[0230] Creating a modified surface region 4011 on one or more of the first and second bones 1604, 1606 using the contour guide may include placing a bone surface modifying instrument on the contour guide and contacting the surface 1615 of at least one of the first and second bones 1604, 1606. For example, a bone surface modifying instrument 4013 placed on the contour guide 4000 and contacting the surface region 1615 of at least one of the first and second bones 1604, 1606 may be configured to fracture the bone at the surface region 1615 of at least one of the first and second bones 1604, 1606 to form the modified surface region 4011. In some exemplary applications, the bone surface modifying instrument placed on the contour guide and contacting the surface region 1615 of at least one of the first and second bones 1604, 1606 may include at least one of a burr and a saw.

[0231] 15B , the contour guide 4000 can be configured to guide the creation of a modified surface region 4011 on one or more of the first and second bones 1604, 1606. For example, the modified surface region 4011 on one or more of the first and second bones 1604, 1606 can be created using the guide slots 4010 of the contour guide 4000. For example, the modified surface region 4011 can be created on one or more regions of the first and second bones 1604, 1606 that are bounded by the guide slots 4010. This can include, for example, creating the modified surface region 4011 on each region of the first and second bones 1604, 1606 that is bounded by the guide slots 4010. One or more bone surface modifying instruments can be placed in the guide slot 4010 and, when placed in the guide slot 4010, can be used to create modified surface regions 4011 on at least one of the first bone 1604 and the second bone 1606 on one or more regions of the first bone 1604, 1606 corresponding to one or more regions of the first bone 1604 and the second bone 1606 that contact the guide slot 4010.

[0232] In some examples, in addition to the guide slot 4010, the contour guide 4000 may include one or more guide openings 4008 that may be used to guide the placement of one or more bone surface modifying instruments 4013 to create the modified surface region 4011. In one such example, modifying the surface 1615 of at least one of the first and second bones 1604, 1606 using the contour guide 4000 to form the modified surface region 4011 on one or more of the first and second bones 1604, 1606 may include positioning at least one bone surface modifying instrument 4013 at least partially in the guide opening 4008, at least partially in the guide slot 4010, and in contact with the surface 1615 of at least one of the first and second bones 1604, 1606 to be modified, so that the one or more bone surface modifying instruments 4013 may be guided to the surface 1615 to be modified using the one or more bone surface modifying instruments 4013. In some cases where the contour guide 4000 is configured such that one or more guide openings 4008 are aligned with the guide slots 4010, this may include, when the contour guide 4000 is positioned on the first and second bones 1604, 1606 and crosses the separation portion 1602, a bone surface modification instrument 4013 is first inserted into the guide openings 4008, then into the guide slots 4010, and then placed in contact with a surface 1615 of at least one of the first and second bones 1604, 1606 to modify that surface 1615 and create a modified surface region 4011.

[0233] In embodiments of technique 2500 that include step 2505 of positioning an implant guide sleeve (e.g., implant guide sleeve 4002, implant guide sleeve 3000), the contour guide 400 can be used to create the modified surface region 4011 when the contour guide 4000 is positioned relative to the implant guide sleeve. As one such example, the contour guide 4000 can be used to modify the surface 1615 of at least one of the first and second bones 1604, 1606 to create the modified surface region 4011 while the contour guide 4000 is at least partially positioned within the implant guide sleeve (e.g., implant guide sleeve 4002, implant guide sleeve 3000).

[0234] In step 2520, technique 2500 may include positioning an implant in contact with at least the modified surface region 4011. In an application of technique 2500 using a contour guide to create a first modified surface region 4011 on the first bone 1604 and a second modified surface region 4011 on the second bone 1606, in step 2520, an implant may be placed in contact with at least the first modified surface region 4011 on the first bone 1604 and the second modified second surface region 4011 on the second bone 1606. In one such exemplary application, where the implant is a staple, the first bone 1604 is a metatarsal, the second bone 1606 is a cuneiform bone, and the separation 1602 between the first and second bones is the joint space between the metatarsal and the cuneiform bone, placing the implant in contact with at least the modified surface area 4011 in step 2520 may include placing a first leg of the staple through the first modified surface area 4011 at the metatarsal and placing a second leg of the staple through the second modified surface area 4011 at the cuneiform bone. Further, in this exemplary application, step 2520 may further include placing an implant in contact with each of the first modified surface area 4011 on the first bone 1604 and the second modified surface area 4011 on the second bone 1606, and bridging the separation 1602 between the first bone 1604 and the second bone 1606 along the implant.

[0235] In embodiments of technique 2500 that include step 2505 of positioning an implant guide sleeve (e.g., implant guide sleeve 4002, implant guide sleeve 3000), after positioning a contour guide with the implant guide sleeve in step 2510, and after modifying a surface region of at least one of the first bone and the second bone using the contour guide in step 2515 to form a modified surface region on one or more of the first bone and the second bone, step 2520 may include positioning an implant on the modified surface region relative to the implant guide sleeve. For example, after modifying a surface region of at least one of the first bone and the second bone using the contour guide to form a modified surface region on one or more of the first bone and the second bone in step 2515, the contour guide can be removed with the implant guide sleeve, remaining fixed on one or both of the first and second bones. The implant guide sleeve can then be used to guide and position an implant on the modified surface region on one or both of the first and second bones. In one particular such application, after positioning the contour guide using the implant guide sleeve in step 2510, and modifying a surface region of at least one of the first bone and the second bone using the contour guide in step 2515 to form a modified surface region on one or more of the first bone and the second bone, step 2520 may include advancing an inserter operatively connected to the implant relative to the implant guide sleeve to position the implant at the modified surface region relative to the implant guide sleeve and placing the implant in contact with at least the modified surface region.

[0236] In some examples, the use of a contour guide 4000 as described herein can be incorporated into the method 1500. For example, the use of a contour guide 4000 as described herein can be incorporated into the method 1500 before steps 1540, 1550 in which the implant is positioned. In one particular such example, the use of a contour guide 4000 as described herein can be incorporated into the method 1500 after the implant guide sleeve is placed in step 1510 (e.g., after the implant guide sleeve is secured if step 1520 is included) and before steps 1540, 1550.

[0237] 16A-16C illustrate one embodiment of a trial member 5000. FIGS. 16A-16C illustrate an embodiment in which the trial member 5000 is included in a drill guide 2040, as described elsewhere herein. When the trial member 5000 is included in the drill guide 2040, the trial member 5000 can extend, for example, between a first drill guide sleeve 2041 and a second drill guide sleeve 2042. However, other embodiments within the scope of the present disclosure can include the trial member 5000 separately as a separate individual component. FIG. 16A is a perspective view of the trial member 5000 in the drill guide 2040, FIG. 16B is an elevation view of the trial member 5000 positioned on one or more bone portions 1604, 1606, and FIG. 16C is a plan view of the trial member 5000 in the drill guide 2040. The trial member 5000 may be configured to approximate the size and / or shape of an implant, such as a staple, to be placed in the one or more bone portions 1604, 1606, thereby allowing a preview of how the implant will be positioned in the one or more bone portions 1604, 1606. This may be useful, for example, to provide a preview of how such an implant will be positioned in the one or more bone portions 1604, 1606 prior to drilling one or more holes in the one or more bone portions 1604, 1606 that will be used to secure the implant to the one or more bone portions 1604, 1606.

[0238] The trial member 5000 can include one or more dimensions that mimic (e.g., approximate or match) an implant to be placed in one or more bone portions 1604, 1606. For example, if the implant to be mimicked is a staple (e.g., staples 500, 600, 700, 800), the trial member 5000 can include a first end 5002, a second end 5004, and a trial bridge 5006 extending between the first end 5002 and the second end 5004. As best shown in FIG. 16B , the trial bridge 5006 can include an arch 5007 and a thickness 5009 between the first end 5002 and the second end 5004. The arch 5007 can mimic (e.g., approximate, match) the curvature of the bridge of a subsequently placed staple, and similarly, the thickness 5009 can mimic (e.g., approximate, match) the thickness of the bridge of a subsequently placed staple. Because the arch 5007 and / or thickness 5009 can mimic the contour and thickness of a staple that will then be placed in one or more bone portions 1604, 1606, the trial member 5000 can be placed in one or more bone portions 1604, 1606 before placing a staple therein so that the trial member 5000 can provide a preview as to whether the staple will fit the surface of the one or more bone portions 1604, 1606.

[0239] In some embodiments, the trial member 5000 can also include an alignment feature 5010. The alignment feature 5010 can be positioned on the bridge 5006. The alignment feature 5010 can be configured to provide an indication (e.g., a visual indication) corresponding to a central region (e.g., a centerline) of the trial member 5000. When the trial member 5000 is placed on the one or more bone portions 1604, 1606, the alignment feature 5010 can align with the separation 1602 between the bone portions 1604, 1606 (e.g., a joint space such as a TMT joint space), as shown in FIG. 16B , thereby helping to provide a reference for placing the trial member 5000 relative to the one or more bone portions 1604, 1606 in the same or generally the same location where a staple will subsequently be placed.

[0240] In certain embodiments, the trial member 5000 can further include one or more friction elements 5012. The one or more friction elements 5012 can be configured to increase friction between a surface of the trial member 5000 (e.g., an underside that contacts the one or more bone portions 1604, 1606) and the one or more bone portions 1604, 1606 on which the trial member 5000 is placed. This can be useful to help stabilize the relative positioning between the trial member 5000 and the one or more bone portions 1604, 1606. The illustrated embodiment of the trial member 5000 includes multiple friction elements 5012 in the form of teeth. However, other embodiments can additionally or alternatively include other types of friction elements.

[0241] As previously described, the trial member 5000 can be used in a method for placing an implant in one or more bone portions 1604,1606.

[0242] In a first step, the trial member 5000 is positioned at (e.g., in contact with) one or more bone portions 1604, 1606. The trial member 5000 can be positioned at one or more bone portions 1604, 1606 such that a first end 5002 abuts one bone portion 1604 and a second end 5004 abuts another bone portion 1606. If the trial member 5000 includes an alignment feature 5010, this step may also include positioning the trial member 5000 at one or more bone portions 1604, 1606 such that the alignment feature 5010 abuts the separation portion 1602.

[0243] In a second step, the relative fit of the trial member 5000 on one or more bone portions 1604, 1606 can be determined. This may include, for example, determining the fit of the arch 5007 to the curvature of the surface of the one or more bone portions 1604, 1606.

[0244] If the relative fit of the trial member 5000 on the surface of the one or more bone portions 1604, 1606 is found to be suitable, then one or more implant holes can be created in the one or more bone portions 1604, 1606. This may include creating one or more implant holes in the one or more bone portions 1604, 1606 while the trial member 5000 is positioned in the same one or more bone portions 1604, 1606. By way of example, the one or more implant holes can be created using the drill guide 2040, e.g., by creating a first implant hole via a first drill guide sleeve 2041 adjacent the first end 5002 of the trial member 5000 and creating a second implant hole via a second drill guide sleeve 2042 adjacent the second end 5004 of the trial member 5000.

[0245] If the relative fit of the trial member 5000 on one or more bone portions 1604, 1606 is determined to be inappropriate, at least a portion of the surface of the one or more bone portions 1604, 1606 on which the trial member 5000 is placed can be modified, or the trial member 5000 can be moved and placed on a different surface area of ​​the one or more bone portions 1604, 1606 to simulate and evaluate the fit of a corresponding staple on that different surface area. For embodiments in which the surface of the bone portions 1604, 1606 is modified after the trial member 5000 is placed thereon, this can include modifying at least a portion of the surface of the one or more bone portions 1604, 1606 to change the fit between the trial member 5000 and the surface of the one or more bone portions 1604, 1606. As one particular such example, the contour guide 4000 can be used as disclosed elsewhere herein to modify the surface on one or more bone portions 1604, 1606. If the fit of the trial member 5000 in one or more bone portions 1604, 1606 is found to be adequate, then one or more implant holes can be created in the one or more bone portions 1604, 1606 as described.

[0246] In a third step, staples may be placed on the surface of the bone portion 1604, 1606 where a relative fit between the trial member 5000 and the surface of the bone portion 1604, 1606 has been found to be adequate. This may involve placing the legs (e.g., tines) of the staples into implant holes created using a drill guide sleeve adjacent to the trial member 5000.

[0247] Figures 16D and 16E illustrate further embodiments of a trial member 5000 for the drill guide 2040 of Figures 16A-16C that includes one or more openings 5026, 5028. Figure 16D is a perspective view and Figure 16E is a top view of an exemplary trial member 5000 for the drill guide 2040 that includes one or more pin openings 5026, 5028.

[0248] 16D and 16E , in addition to the trial member 5000, the drill guide 2040 can include one or more pin openings 5026, 5028. The illustrated embodiment shows that the drill guide 2040 can include the trial member 5000, a first drill guide sleeve 2041, a second drill guide sleeve 2042, a first pin opening 5026, and a second pin opening 5028. The trial member 5000, the first drill guide sleeve 2041, and the second drill guide sleeve 2042 can be similar to those disclosed elsewhere herein. The first pin opening 5026 can be configured to receive a pin or wire therethrough into the bone, and the second pin opening 5028 can be configured to receive another pin or wire therethrough into the bone (e.g., the same bone as the first pin opening 5026 or a different bone). Thus, each of the first and second pin openings 5026, 5028 may be open at a proximal end and at opposite distal bone-facing ends. A pin or wire may be inserted through the first and / or second pin openings 5026, 5028 to temporarily secure the drill guide 2040 and trial member 5000 in one or more bone portions (e.g., for temporary fixation while the drill guide 2040 is being used to drill one or more implant-receiving holes and / or while the trial member 5000 is being used in one or more bone portions).

[0249] For applications in which the drill guide 2040 and trial member 5000 are used in conjunction with a procedure to place an implant (e.g., a staple) across a bone portion, when the drill guide 2040 and trial member 5000 are positioned against such a bone portion, the first pin opening 5026 may be positioned in the drill guide 2040 to be positioned on the first bone portion and the second pin opening 5028 may be positioned in the drill guide 2040 to be positioned on the second bone portion. As noted elsewhere herein, the first drill guide sleeve 2041 may be positioned in the drill guide 2040 to be positioned on the first bone portion, such that the first pin opening 5026 may be positioned in the drill guide 2040 adjacent the first drill guide sleeve 2041. Similarly, as described elsewhere herein, a second drill guide sleeve 2042 can be positioned in the drill guide 2040 to be positioned on the second bone portion, such that the second pin opening 5028 can be positioned in the drill guide 2040 adjacent to the second drill guide sleeve 2042. In embodiments including an alignment feature 5010, the first pin opening 5026 and the first drill guide sleeve 2041 can be positioned on one side of the alignment feature 5010, and the second pin opening 5028 and the second drill guide sleeve 2042 can be positioned on another, opposite side of the alignment feature 5010.Thus, the alignment feature 5010 can be positioned on the trial member 5000, the alignment feature being configured to be positioned over the space 1602 between the first and second bone portions 1604, 1606, and the first pin opening 5026, the first drill guide sleeve 2041, and the first end 5002 of the trial member 5000 can be positioned on the drill guide 2040 and the trial member 5000, and the first pin opening 5026, the first drill guide sleeve 2041, and the trial member 5000 can be positioned over the space 1602 between the first and second bone portions 1604, 1606. Each of the first ends 5002 of the drill guide 2040 and the trial member 5000 is configured to be positioned on the first bone portion 1604, and the second pin openings 5028, the second drill guide sleeve 2042, and the second end 5004 of the trial member 5000 can be positioned in the drill guide 2040 and the trial member 5000, and the second pin openings 5028, the second drill guide sleeve 2042, and the second end 5004 of the trial member 5000 are configured to be positioned on the second bone portion 1606.

[0250] 17A and 17B illustrate another embodiment of a trial member 6000 in a drill guide 2040. FIG. 17A is a perspective view of the trial member 6000 in the drill guide 2040, and FIG. 17B is an elevational view of the trial member 6000 positioned on one or more bone portions 1604, 1606. While FIGS. 17A and 17B illustrate an embodiment in which the trial member 6000 is included in the drill guide 2040 described elsewhere herein, other embodiments within the scope of the present disclosure may include the trial member 6000 separately as a separate individual component.

[0251] The trial member 6000 may be similar to or the same as the previously disclosed trial member 5000, unless otherwise specified herein. That is, the trial member 6000 may be configured to mimic a different implant than the trial member 5000. For example, the trial member 5000 may be configured to mimic a first staple design, while the trial member 6000 may be configured to mimic a second, different staple design. Specifically, with respect to the illustrated embodiment, the trial member 5000 may be configured to resemble a staple having two legs—one on each side of a bridge—while the trial member 5000 may be configured to resemble a staple having four legs—two on each side of a bridge. Similar to the trial member 5000, the trial member 6000 can be configured to approximate the size and / or shape of a staple (e.g., having four legs) to be placed in one or more bone portions 1604, 1606, thereby allowing a preview of how such staple will be positioned in one or more bone portions 1604, 1606. As shown with respect to the examples herein, the drill guide 2040 can include a plurality of drill guide sleeves 2041 on one side of the drill guide 2040 (e.g., the side configured to be positioned on the first bone portion 1604) and a plurality of drill guide sleeves 2042 on another opposite side of the drill guide 2040 (e.g., the other opposite side configured to be positioned on the second bone portion 1606).

[0252] Figures 17C and 17D illustrate further embodiments of a trial member 6000 for the drill guide 2040 of Figures 17A-17B that includes one or more openings 5026, 5028. Figure 17C is a perspective view and Figure 17D is a top view of an exemplary trial member 6000 for the drill guide 2040 that includes one or more pin openings 5026, 5028.

[0253] 17C and 17D , in addition to the trial member 6000, the drill guide 2040 can include one or more pin openings 5026, 5028, at least two drill guide sleeves 2041, and at least two drill guide sleeves 2042. The illustrated embodiment shows that the drill guide 2040 can include the trial member 6000, two drill guide sleeves 2041, two drill guide sleeves 2042, a first pin opening 5026, and a second pin opening 5028. The trial member 6000, the drill guide sleeves 2041, 2042, the first pin opening 5026, and the second pin opening 5028 can be similar to those disclosed elsewhere herein. Pins or wires can be inserted through the first and / or second pin openings 5026, 5028 to temporarily secure the drill guide 2040 and trial member 6000 in one or more bone portions. In applications where the drill guide 2040 and trial member 6000 are used in conjunction with a procedure to place an implant (e.g., a staple) across a bone portion, and if the alignment feature 5010 is included, when the drill guide 2040 and trial member 6000 are positioned in contact with such bone portion, the first pin opening 5026 and drill guide sleeve 2041 may be positioned on one side of the alignment feature 5010 and the second pin opening 5028 and drill guide sleeve 2042 may be positioned on another, opposite side of the alignment feature 5010.Thus, the alignment feature 5010 can be positioned on the trial member 6000, the alignment feature 5010 being configured to be positioned over the space 1602 between the first and second bone portions 1604, 1606, the first pin opening 5026, the drill guide sleeve 2041, and the first end 5002 of the trial member 6000 can be positioned on the drill guide 2040 and the trial member 6000, the first pin opening 5026, the first drill guide sleeve 2041, and the trial member Each of the first ends 5002 of the drill guide 2040 and trial member 6000 is configured to be positioned on the first bone portion 1604, and the second pin opening 5028, the drill guide sleeve 2042, and the second end 5004 of the trial member 6000 can be positioned in the drill guide 2040 and trial member 6000, and each of the second pin opening 5028, the second drill guide sleeve 2042, and the second end 5004 of the trial member 6000 is configured to be positioned on the second bone portion 1606.

[0254] 18 is a side view of an embodiment of a pinning and drilling instrument 7000. The pinning and drilling instrument 7000 can be configured to evaluate the location of a proposed implant-receiving opening to be created (e.g., drilled) in a bone portion prior to actually creating the implant-receiving opening in the bone portion, and when the location of the proposed implant-receiving opening is determined to be appropriate, the pinning and drilling instrument 7000 can be configured to create the implant-receiving opening.

[0255] The pinning and drilling instrument 7000 can include a body 7001. The body 7001 can have a proximal body end 7001a and a distal body end 7001b. The body 7001 can include a pin portion 7002 and a drill portion 7004. The pin portion 7002 can be at or near the distal body end 7001b and can extend proximally toward the proximal body end 7001a along a length 7010 of the pin portion of the body 7001. In the illustrated embodiment, the pin portion 7002 forms the distal-most end of the body 7001. The drill portion 7004 can be on the body 7001 proximal to the pin portion 7002 and can extend proximally toward the proximal body end 7001a along a length 7011 of the drill portion of the body 7001. In the illustrated embodiment, the drill portion 7004 begins where the pin portion 7002 ends. For example, the distal end of the drill portion 7004 can begin where the proximal end of the pin portion 7002 ends.

[0256] The pin portion 7002 and the drill portion 7004 can have different widths defined by the body 7001. The pin portion 7002 can have a pin width (e.g., diameter) 7006, and the drill portion 7004 can have a drill width (e.g., diameter) 7008. In the illustrated embodiment, the pin width 7006 is smaller than the drill width 7008. Thus, because the drill width 7008 can be larger than the pin width 7006, the width of the body 7001 of the pinning and drilling instrument 7000 can increase where the pin portion 7002 ends and the drill portion 7004 begins. The change in width at the body 7001 where the pin portion 7002 ends and the drill portion 7004 begins can create a shoulder 7007 in the body 7001 where the drill portion 7004 begins. Thus, the shoulder 7007 can follow the pin portion 7002, and the shoulder 7007 can be at the distal end of the drill portion 7004. As described further herein, this shoulder 7007 may be configured to contact the bone portion after insertion of the pin portion 7002 therein, and such contact between the bone portion and the shoulder 7007 may function to provide tactile feedback to the user indicating that the pin portion 7002 (e.g., the length 7010 of the pin portion) has been inserted into the bone portion. Thus, in some applications where the positioning of the pin portion 7002 in the bone portion is to be evaluated (e.g., by imaging), insertion of the pin portion 7002 into the bone portion may be temporarily terminated when the shoulder 7007 contacts the bone portion to enable such evaluation of the positioning of the pin portion 7002 within the bone portion.

[0257] The difference in width between the pin portion 7002 and the drill portion 7004 may, in some embodiments, result in a difference in cross-sectional area between the pin portion 7002 and the drill portion 7004. In such embodiments, the pin portion 7002 may define a first cross-sectional area of ​​the body 7001, and the drill portion 7004 may define a second cross-sectional area of ​​the body 7001 that is different from the first cross-sectional area of ​​the body 7001. In the exemplary illustrated embodiment, the second cross-sectional area defined in the body 7001 by the drill portion 7004 is larger than the first cross-sectional area defined in the body 7001 by the pin portion 7002.

[0258] As described above, the pin portion 7002 can be configured to be inserted into a bone portion. For example, the pin portion 7002 can be configured to create a tacking opening in the bone. In the illustrated embodiment, the pin portion 7002 includes a pointed end 7003 that, when contacted and advanced through the bone, can be configured to cut through the surface of the bone and create a tacking opening at the location of the bone through which the pin portion 7002 advances.

[0259] The drill portion 7004 can be configured to create an implant-receiving opening in the bone. For example, the drill portion 7004 can include drill flutes 7005 configured to create an implant-receiving opening in the bone (e.g., to receive a portion of an implant, such as a leg of a staple). For example, the pinning and drilling instrument 7000 can be rotationally driven, causing the drill flutes 7005 to fracture the bone and create the implant-receiving opening. The drill flutes 7005 can begin generally where the pin portion 7002 ends; for example, the drill flutes 7005 can begin at the shoulder 7007 and extend proximally along the body 7001 from there. The pinning and drilling instrument 7000 has a drill portion 7004 that is proximal to and follows the pin portion 7002, and the drill portion 7004 can be configured to create an implant-receiving opening in the bone at least at the location of the tacking opening previously created by the leading pin portion 7002. Thus, the pinning and drilling instrument 7000 can be configured to be placed in contact with bone and, as it advances into the bone, to first create a tacking opening in the bone via the pin portion 7002, and then, as it advances further into the bone, the pinning and drilling instrument 7000 can be configured to create an implant-receiving opening in the bone via the drill portion 7004 in the same location in the bone where the tacking opening was previously created by at least the pin portion 7002. The tacking opening can have a smaller diameter than the implant-receiving opening. For example, the width 7006 of the pin can be smaller than the width 7008 of the drill, such that the diameter of the tacking opening created by the pin portion 7002 can be smaller than the diameter of the implant-receiving opening subsequently created by the drill portion 7004.

[0260] The pin portion 7002 can be configured to aid in evaluating the proposed positioning of an implant in one or more bone portions. Certain applications involving the placement of an implant in one or more bone portions can include creating an implant-receiving opening in the bone portion to receive at least a portion of the implant within the bone in the implant-receiving opening. For such applications, the pin portion 7002 can be configured to aid in evaluating the proposed positioning of the implant prior to creating the implant-receiving opening in the bone portion with the drill portion 7004. For example, the pin portion 7002 can have a pin length 7010 equal to the length of the implant portion to be implanted in the bone (e.g., in the bone), and thus the pin portion 7002 can provide a visual indication (e.g., via imaging) of the positioning of the implant within the bone. Notably, in some applications, the pin portion 7002 can be configured to simulate the location of the proposed implant-receiving opening to be created in the bone portion (e.g., drilled using the drill portion 7004), which can then serve as a surrogate for the positioning of an implant to be placed in the proposed implant-receiving opening prior to actually creating the implant-receiving opening in the bone portion. This may allow for evaluation and either (i) confirmation that the location of the implant receiving opening is appropriate for receiving the implant, or (ii) a determination that the location of the implant receiving opening is not appropriate for receiving the implant and should be moved, in which case the pin portion 7003 can be removed from its location in the bone portion and repositioned in a new location in the same or a different bone portion for a new evaluation.

[0261] In embodiments where the implant to be placed in one or more bone portions is a staple, the pin portion 7002 can be configured to aid in evaluating the proposed positioning of the staple legs at (e.g., within) the bone portion. For example, the pin portion 7002 can have a pin length 7010 equal to the leg length of the staple to be implanted. For example, certain staple designs have leg lengths of 12 mm, 13 mm, or 16 mm. If the leg length of the staple to be placed in the bone portion is 12 mm, the pin length 7010 can be 12 mm; if the leg length of the staple to be placed in the bone portion is 13 mm, the pin length 7010 can be 13 mm; and if the leg length of the staple to be placed in the bone portion is 16 mm, the pin length 7010 can be 16 mm. Thus, in this example, visually confirming (e.g., through imaging) the position of the pin length 7010 at the bone portion can facilitate evaluating what the positioning of the staple legs will be if the staple legs are inserted at the location of the pin length 7010. To do so, the pin length 7010 of the pin portion 7002 can be inserted into the bone portion and image data (e.g., fluoroscopic image data) can be generated to visualize the location of the pin length 7010 within the bone portion. If the location of the pin length 7010 within the bone portion is determined to be suitable for placing staple legs at that location, the pinning and drilling instrument 7000 can be further inserted into the bone portion causing the drill portion 7004 to create implant-receiving openings in the same location as the pin length 7010 positioned within the bone portion was determined to be suitable. On the other hand, if the location of the pin length 7010 within the bone portion is determined to be suitable for placing staple legs at that location, the pin portion 7002 can be removed from its location in the bone portion and the pin portion 7002, including the pin length 7010 simulating the staple legs, can be inserted into a different bone portion location for evaluation of a new positioning.Thus, the pinning and drilling instrument 7000 can facilitate both initially simulating a staple leg location via the pin length 7010 of the pin portion 7002 and subsequently creating an implant-receiving opening via the drill portion 7004 at that simulated staple leg location for placing the staple leg at that location.

[0262] In some embodiments, such as those shown herein, the pinning and drilling instrument 7000 can include a visual indicator 7012 and an interference stop 7014 on the body 7001. The visual indicator 7012 can be positioned on the body 7001 proximal to the pin portion 7002 and proximal to the drill portion 7004. Additionally, the visual indicator 7012 can be positioned at a location along the length of the body 7001 that corresponds to a positioning where the pin portion 7002 is fully inserted into the bone. For example, in an application such as the example shown in FIG. 22B , when the pinning and drilling instrument 7000 is inserted into the bone in combination with a drill guide (e.g., drill guide 2040) that includes drill guide sleeves 2041, 2042 for receiving the pinning and drilling instrument 7000, the length between the distal tip of the drill portion 7004 and the visual indicator 7012 (e.g., the length between the shoulder 7007 and the visual indicator 7012) can be equal to the length of the drill guide sleeves 2041, 2042. Thus, when the pinning and drilling instrument 7000 is inserted into the bone and the visual indicator 7012 is moved adjacent to (e.g., across) the distal end of the drill guide sleeve 2041, 2042, as shown in FIG. 22B, this can provide an indication (e.g., a visual indicator) to the user that the pin portion 7002 is fully inserted into the bone (e.g., the shoulder 7007 contacts the outer surface of the bone).

[0263] Also, in some embodiments, the length 7016 defined between the visual indicator 7012 and the interference stop 7014 can be equal to the pin length 7010 and therefore equal to the length of the implant portion to be placed within the bone portion. In implant-stable applications, the length 7016 defined between the visual indicator 7012 and the interference stop 7014 can be equal to the pin length 7010 and therefore equal to the leg length of the staple to be implanted. Thus, this length 7016 between the visual indicator 7012 and the interference stop 7014 can serve as a visual reference when inserting the drill portion 7004 into the bone portion to guide the length of the drill portion 7004 inserted into the bone, which corresponds to the length 7016 simulating the leg length of the staple. In other words, the visual indicator 7012 can provide an indication as to when the pin length 7010 is inserted into the bone, and because the pin length 7010 can correspond to the leg length of a staple, can provide an indication that the pin length 7010 inserted into the bone simulates the leg length of a staple inserted in the same location within the bone.

[0264] In embodiments where it may be desirable to insert at least a portion of the pinning and drilling instrument 7000 into a bone portion using a drive tool, the pinning and drilling instrument 7000 may include a driver engagement portion 7015. The driver engagement portion 7015 may be proximal to the drill portion 7004. The illustrated embodiment shows the driver engagement portion 7015 at the distal end of the body 7001. The driver engagement portion 7015 may be configured (e.g., sized and / or shaped) for insertion into a powered driver. The driver engagement portion 7015 may have a length and diameter that allows the driver engagement portion 7015 to be inserted to a depth appropriate for the powered driver to then actuate the pinning and drilling instrument 7000 to drive (e.g., rotationally drive) the pinning and drilling instrument 7000 into a surgical procedure. For example, the pinning and drilling tool 7000 can be coupled to a powered driver at the driver engagement portion 7015, and the pinning and drilling tool 7000 can be rotationally driven by the powered driver to cause the drill portion 7004 to create an implant-receiving opening.

[0265] 19A-19B show another embodiment of a pinning and puncturing instrument 7100. The pinning and puncturing instrument 7100 may be similar to or the same as the pinning and puncturing instrument 7000 described elsewhere herein, except as otherwise disclosed herein with respect to FIGS. 19A-19B. FIG. 19A is a side view of the pinning and puncturing instrument 7100 in an exemplary pinning configuration 7150. FIG. 19B is a side view of the pinning and puncturing instrument 7100 in an exemplary puncturing configuration 7151.

[0266] The pinning and drilling instrument 7100 can be adjustable between a pinning configuration 7150 and a drilling configuration 7151. In the pinning configuration 7150, the pin portion 7002 (e.g., pointed end 7003) can extend further from the drill portion 7004 than in the drill configuration 7151. In one example of such a pin configuration 7150, the pin portion 7002 can extend from the shoulder 7007 to a pin portion length 7010 that is equal to a portion of the implant (e.g., staple leg) that will be subsequently implanted at the location where the pin portion length 7010 is inserted into the bone. In another example of such a drilling configuration 7151, the pin portion 7002 can extend out from the shoulder 7007 a distance less than the pin portion length 7010. For example, as shown for the illustrated embodiment, in drill configuration 7151 at least a portion of the length 7010 of the extended pin portion in pinning configuration 7150 can be nested inside the drill portion 7004.

[0267] To facilitate adjustment between such configurations, the pinning and drilling instrument 7100 can include, at least in part, portions coupled together and movable relative to one another to alter the pinning and drilling instrument 7100 between the pinning configuration 7150 and the drilling configuration 7151. The illustrated embodiment of the pinning and drilling instrument 7100 can include a pin shaft 7110 having a pin portion 7002 (e.g., at the distal end of the pin shaft 7110) and a drill shaft 7112 having a drill portion 7004 (e.g., at the distal end of the end of the drill shaft 7112). The pin shaft 7110 and the drill shaft 7112 can be movable independently of one another over at least a predetermined range of movement to adjust the pinning and drilling instrument 7100 between the pinning configuration 7150 and the drilling configuration 7151. For example, the pin shaft 7112, and thus the pin portion 7002, and the drill shaft 7110, and thus the drill portion 7004, may be movable independently of one another through a first range of movement, but may be movable together through a different second range of movement. For example, the pin shaft 7112, and thus the pin portion 7002, and the drill shaft 7110, and thus the drill portion 7004, may be movable independently of one another through a first range of movement that includes inserting the pin portion 7002 into the bone and inserting at least a portion of the drill portion 7004 into the bone. However, the pin shaft 7112, and thus the pin portion 7002, and the drill shaft 7110, and thus the drill portion 7004, may be movable together through a second range of movement that includes further inserting the drill portion 7004 into the bone beyond the range of insertion of the drill portion 7004 through the first range of movement.

[0268] To facilitate adjustment between the pinning configuration 7150 and the drilling configuration 7151, in the illustrated embodiment of the pinning and drilling instrument 7100, the pin shaft 7110 may include a step 7114 (e.g., proximal to the pin portion 7002) and the drill shaft 7112 may include a chamber 7116 (e.g., proximal to the drill portion 7004). The chamber 7116 may include a distal step stop 7117 and a proximal step stop 7118. The step 7114 of the pin shaft 7110 may be positioned within the chamber 7116 and movable through a range of motion 7120 between the distal step stop 7117 and the proximal step stop 7118 as the pin shaft 7110 and the drill shaft 7112 are moved relative to one another. Furthermore, as the step 7114 of the pin shaft 7110 moves into contact with the distal step stop 7117 and / or the proximal step stop 7118, the engagement between the step 7114 and the step stop 7117 and / or 7118 can cause relative movement between the stationary pin shaft 7110 and drill shaft 7112, thereby acting to allow the pin shaft 7112, and thus the pin portion 7002, and the drill shaft 7110, and thus the drill portion 7004, to move together. For example, as seen in FIG. 19A , when the step 7114 moves away from the proximal step stop 7118, the pin shaft 7110, and thus the pin portion 7002, can move independently from the drill shaft 7112 and thus the drill portion 7004, allowing the pin portion 7002 to extend from the pin portion's length 7010. For example, a user can engage the drill shaft 7112 and apply power to translate the drill shaft 7112 relative to and towards the pin portion 7002 that is inserted into the bone.Then, as can be seen in FIG. 19B , as a result of movement of the drill shaft 7112 relative to the pin shaft 7110, when the step 7114 engages at the proximal step stop 7118, the pin shaft 7110, and therefore the pin portion 7002, may be movable together (e.g., most of the length 7010 of the pin portion is nested within the drill shaft 7112), while the step 7114 engages with the proximal step stop 7118 on the drill shaft 7112.

[0269] 20A-20B illustrate another embodiment of a pinning and puncturing instrument 7200. The pinning and puncturing instrument 7200 may be similar to or the same as the pinning and puncturing instruments 7000, 7100 described elsewhere herein, except as otherwise disclosed herein with respect to FIGS. 20A-20B. FIG. 20A is a side view of the pinning and puncturing instrument 7200 in an exemplary pinning configuration 7150. FIG. 20B is a side view of the pinning and puncturing instrument 7200 in an exemplary puncturing configuration 7151.

[0270] Like the pinning and drilling instrument 7100, the pinning and drilling instrument 7200 may be adjustable between a pinning configuration 7150 and a drilling configuration 7151. The pinning and drilling instrument 7100 includes a pin shaft 7110 and a drill shaft 7112 coupled together via a chamber 7116, as previously disclosed, thus limiting relative independent movement between the pin shaft 7110 and the drill shaft 7112 over a distance 7120 between step stops 7117, 7118. The pinning and drilling instrument 7200 includes a pin shaft 7110 and a drill shaft 7112 that are decoupled from each other, and thus the pinning and drilling instrument 7200 may be configured to allow relative movement between the pin shaft 7110 and the drill shaft 7112 over a wider range than that limited by stop 7218. A stop 7128 may be included on the drill shaft 7112. When the step 7114 is spaced apart from the stop 7128, the pin shaft 7110 and the drill shaft 7112 may be movable independently of each other, but when the step 7114 is engaged at the stop 7128, the pin shaft 7110 and the drill shaft 7112 may be movable together.

[0271] The pinning and drilling instrument 7200 may be used in the pinning configuration 7150 and the drilling configuration 7151 as disclosed elsewhere herein with respect to the pinning and drilling instruments 7000, 7100. As an example, as disclosed elsewhere herein, the pinning and drilling instrument 7000, 7100, 7200 may be used in a method of simulating and using the pinning and drilling instrument 7000, 7100, 7200 to identify a simulated location of an implant (e.g., using the pin length 7010 of the pin portion 7002) and creating an implant-receiving opening at the simulated location.

[0272] Figure 21 is a flow diagram of an exemplary surgical technique 7500 using pinning and piercing instruments to create an implant-receiving opening into which an implant may be placed. Figures 22A-22C are referenced for exemplary and explanatory purposes in the following disclosure related to technique 7500. That is, Figures 22A-22C illustrate the use of an exemplary series of pinning and piercing instruments to create an implant-receiving opening into which an implant may be placed.

[0273] 22A shows a side view of two pinning and drilling instruments 7000 being advanced toward an exemplary drill guide 2040 positioned on bony portions 1604, 1606 of the foot. FIG. 22A shows one exemplary application of technique 2500 on one or more bones of the foot using drill guide 2040 and two pinning and drilling instruments 7000. However, other applications of technique 2500 can be performed on one or more bones in other portions of the anatomy, with or without drill guides, with only one pinning and drilling instrument 7000, with three or more pinning and drilling instruments 7000, and / or with other pinning and drilling instrument embodiments, such as pinning and drilling instruments 7100 and / or 7200.

[0274] In various applications of technique 2500, the one or more bone portions 1604, 1606 can be bone portions of the same bone or different bones. For example, the one or more bone portions can include a first bone 1604 and a second bone 1606 separated by a joint space 1602. In the illustrated application of technique 2500, bone portion 1604 is a cuneiform bone (e.g., medial cuneiform bone), bone portion 1604 is a metatarsal bone (e.g., first metatarsal bone), and the space 1602 between the cuneiform bone and the metatarsal bone is a tarsometatarsal joint space.

[0275] In applications of technique 2500 that use a drill guide, technique 2500 may include placing the drill guide in one or more bone portions 1604, 1606. As shown in the exemplary application of FIG. 22A , prior to step 7505, technique 7500 may include placing a drill guide 2040 in one or more bone portions 1604, 1606. The drill guide 2040 may include a trial member 6000 that simulates at least one dimension of the implant (e.g., staple) to be placed in step 7520, as disclosed elsewhere herein. Placing the drill guide 2040 in the first bone 1604 and the second bone 1606 may include placing the trial member 6000 in the first bone 1604, the second bone 1606, and across the joint space 1602 separating the first bone 1604 and the second bone 1606, as shown in FIG. 22A .

[0276] In step 7505, technique 7500 may include inserting a pinning and drilling instrument a first distance into one or more bone portions. Figure 22B illustrates an exemplary application of step 7505, showing a side view of two pinning and drilling instruments 7000 each inserted into a respective bone portion 1604, 1606. In step 7505, the pinning and drilling instrument 7000 may insert the bone portion 1604 or 1606 a first distance at a location on the respective bone portion 1604, 1606 such that the pin portion 7002 of the pinning and drilling instrument 7000 is inserted into the one or more bone portions at the location of the respective bone portion 1604, 1606.

[0277] Inserting the pinning and drilling instrument 7000 a first distance into the respective bone portions 1604, 1606 can include inserting a pin portion length 7010 into the respective bone portion 1604, 1606. As an example, the pin portion length 7010 may be equal to the length of an implant portion to be implanted at (e.g., within) the respective bone portion 1604, 1606. In this example, the pin portion 7002 having inserted the pin portion length 7010 into the respective bone portion 1604, 1606 can provide a visual indication (e.g., by imaging) as to how the implant will be positioned within the respective bone portion 1604, 1606. For example, in applications where the implant is a staple, the pin portion length 7010 can be equal to the leg length of the staple, and inserting the pin portion 7002 into the respective bone portion 1604, 1606 can include inserting the pin portion length 7010, in this example equal to the leg length of a staple that will later be implanted in the same location in the respective bone portion.

[0278] Inserting the pin portion 7002 (e.g., the length 7010 of the pin portion) a first distance into the respective bone portion 1604, 1606 in step 7505 may include creating a tacking opening 7050 in the bone portion 1604, 1606 at the location where the pin portion 7002 is inserted. For example, the tacking opening 7050 may be created by inserting the pin portion 7002 into the respective bone portion 1604, 1606, such that the tacking opening 7050 has a diameter equal to the diameter of the pin portion, and the tacking opening 7050 may extend into the respective bone portion 1604, 1606 a distance equal to the length of the pin portion 7002 inserted into the respective bone portion 1604, 1606. For example, when the pin portion length 7010 is inserted into the respective bone portion 1604, 1606, the tacking opening 7050 can have a length extending into the respective bone portion 1604, 1606 equal to the pin portion length 7010. Thus, if the pin portion length 7010 is equal to the length of an implant portion (e.g., staple legs) to be implanted in the respective bone portion 1604, 1606, the tacking opening 7050 created in step 7505 by inserting the drill portion 7002 into the respective bone portion 1604, 1606 can extend into the respective bone portion 1604, 1606 a distance equal to the length of the implant portion (e.g., staple legs) to be implanted in the respective bone portion 1604, 1606.

[0279] As shown for the exemplary application of technique 7500, a drill guide 2040, or other guide component, may be used to help guide insertion of the pinning and drilling instrument 7000 a first distance into the respective bone portions 1604, 1606 in step 7505. For example, as seen in the exemplary views of FIGS. 22A and 22B , the pinning and drilling instrument 7000 may be inserted a first distance into the respective bone portions 1604, 1606 by inserting the pinning and drilling instrument 7000 relative to the drill guide 2040 in step 7505. As one particular such example, as seen in the exemplary views of FIGS. 22A and 22B , the pinning and drilling instrument 7000 may be inserted a first distance into the respective bone portions 1604, 1606 by inserting the pinning and drilling instrument 7000 a first distance into the respective bone portions 1604, 1606 through the respective guide sleeves 2041, 2041 in step 7505. This may involve inserting the pinning and drilling instrument 7000 a first distance through the respective guide sleeve 2041, 2041 into the respective bone portion 1604, 1606, and provisionally securing the drill guide 2040 to the respective bone portion 1604, 1606 using the pinning and drilling instrument 7000. In the example of Figures 22A and 22B, this involves inserting one pinning and drilling instrument 7000 with the drill guide 2040 (e.g., through one guide sleeve 2041) a first distance into one bone 1604 (e.g., a distance equal to the length 7010 of the pin portion), and inserting another pinning and drilling instrument 7000 with the drill guide 2040 (e.g., through another guide sleeve 2042) a first distance into the other bone 1606 (e.g., a distance equal to the length 7010 of the pin portion). For example, one pinning and punching instrument 7000 can be inserted into bone 1604 with guide sleeve 2041 a first distance equal to the length of the pin portion 7010, which is equal to the first leg of the staple, on a first side of the staple bridge, and another pinning and punching instrument 7000 can be inserted into bone 1606 with guide sleeve 2042 a first distance equal to the second leg of the staple, on a second side of the staple bridge.

[0280] Inserting the pinning and drilling instrument a first distance into the bone portion to insert the pin portion into the bone in step 7505 can be terminated, for example, when the length of the pin portion 7002 inserted into the bone at least approximates the length of an implant that is intended to be placed in the pin at the same location as the length of the pin portion 7002 being inserted. As an example, inserting the pinning and drilling instrument a first distance into the bone in step 7505 can be terminated, for example, when a length 7010 of the pin portion is inserted into the bone that is equal to the length of the implant portion that will be implanted in the bone at the same location. In some examples, to help provide feedback to the user as to when to terminate inserting the pin portion a first distance into the bone in step 7505, contact between the shoulder 7007 and the bone into which the pin portion is inserted can be used as an indication to terminate insertion of the pin portion in step 7505. For example, insertion of the pin portion a first distance into the bone in step 7505 can be temporarily terminated when shoulder 7007 contacts the respective bone 1604, 1606, as shown in FIG. 22B. In examples where shoulder 7007 defines a tip of a second cross-sectional area in drill portion 7004 of body 7001 that is larger than the first cross-sectional area of ​​pin portion 7002 in body 7001, insertion of the pin portion a first distance into the bone in step 7505 can be temporarily terminated when the second cross-sectional area contacts the bone portion into which pin portion 7002 is inserted.

[0281] To enable assessment of the position of the pin portion 7002 within the bone, a visual indicator 7012 may be included to assist in determining when to finish inserting the pin portion 7002. For example, the visual indicator 7012 may be at a location along the length of the body 7001 that corresponds to positioning the pin portion 7002 fully inserted into the bone. Thus, when the visual indicator 7012 is moved into position, it can provide an indication to the user that the pin portion 7002 (e.g., the length 7010 of the pin portion) has been fully inserted into the bone. For the illustrative example application shown in FIG. 22B , inserting the pinning and drilling instrument a first distance into the bone portion so that the pin portion is inserted into the bone in step 7505 can be completed when the visual indicator 7012 is moved into position relative to the drill guide 2040. 22B , inserting the pinning and drilling instrument a first distance into the bone portion so that the pin portion is inserted into the bone in step 7505 can be terminated when the visual indicator 7012 is moved into a predetermined position relative to the guide sleeve 2041 or 2042 of the drill guide. For example, when the visual indicator 7012 is moved adjacent to or at least partially aligned with the respective guide sleeve 2041, 2042, insertion of the pin portion 7002 can be considered to be achieved and further insertion of the pinning and drilling instrument 7000 into the bone can be temporarily terminated to assess the position of the pin portion 7002 within the bone.

[0282] In step 7510, technique 7500 may include imaging at least a portion of a pin portion of the pinning and drilling instrument that is inserted into the bone portion. Imaging the position of the pin portion within one or more bone portions in step 7510 may occur after inserting the pinning and drilling instrument 7000 into one or more bone portions a first distance (e.g., pin portion length 7010) and before creating an implant-receiving opening at that location by further inserting the pinning and drilling instrument a second, additional distance into the one or more bone portions. When inserting the pinning and drilling instrument 7000 into the bone portion a first distance to approximate and simulate the distance a portion of an implant will be inserted into the bone portion (e.g., when the pinning and drilling instrument is inserted into the bone portion a pin portion length 7010 equal to the leg length of a staple) in step 7505, imaging the position of the pin portion 7002 inserted into the bone portion can capture image data using the inserted pin portion 7002 to represent a potential subsequent location for inserting an implant portion (e.g., the leg of a staple). This therefore makes it possible to evaluate the proposed location of the implant portion (e.g., staple leg) to be inserted using captured image data of the pin portion to be inserted into the bone portion to determine whether such location is actually suitable for placing the implant portion there at that time.

[0283]

[0071] The imaging at step 7510 may include generating or otherwise obtaining image data representing the position of the pin portion inserted a first distance into the bone portion. Various imaging modalities can be used to perform the imaging at step 7510. As an example, the imaging at step 7510 may include generating or otherwise obtaining fluoroscopic image data representing the position of the pin portion inserted a first distance into the bone portion. For applications of technique 7500 where bone portion 1604 is a first bone (e.g., a cuneiform bone), bone portion 1606 is a second bone (e.g., a metatarsal bone), and cavity 1602 is a joint cavity between the first and second bones (e.g., a medial cuneiform bone), imaging the position of the pin portion 7002 in one of the first and second bones may include imaging the position of the pin portion 7002 in one of the first and second bones relative to the joint cavity. For example, in some applications, it may be useful to evaluate a proposed location of an implant portion to be inserted into a bone using captured image data of the pin portion within the bone as a surrogate and to evaluate the proposed location relative to the joint cavity using the captured image data. If the proposed location of the implant portion to be inserted into the bone is determined to be appropriate using the captured image data of the pin portion within the bone relative to the joint cavity, the technique can proceed to step 7515. As an example, when the imaged location of the pin portion 7002 determines that the pin portion 7002 is spaced from the joint cavity adjacent one or more bones, an implant-receiving opening can be created at that location by further inserting the pinning and drilling instrument into one or more bone portions (e.g., by inserting a drill portion). On the other hand, if the proposed location of the implant portion to be inserted into the bone is determined to be inappropriate using the captured image data of the pin portion within the bone relative to the joint cavity, the pin portion can be removed from its location within the bone portion, and steps 7505 and 7510 can be repeated at a new location of the bone portion relative to the joint cavity.

[0284] In step 7515, technique 7500 may include creating an implant-receiving opening 7051. The implant-receiving opening 7051 may be created in step 7515 using the drill portion 7004 of the pinning and drilling instrument 7000. For example, the implant-receiving opening 7051 may be created in the bone portion where the pin portion 7002 was inserted by further inserting the pinning and drilling instrument 7000 a second further distance into the respective bone portion, such that the drill portion 7004 of the pinning and drilling instrument 7000 is inserted into the bone portion to create the implant-receiving opening 7051 at that location. The implant-receiving opening 7051 may be created in step 7515 using the drill portion 7004 of the pinning and drilling instrument 7000 after inserting the pinning and drilling instrument 7000 (e.g., pin portion 7002) into the same bone portion a first distance (e.g., equal to the length 7010 of the pin portion) in step 7505. Thus, in such an application of technique 7500, when the pin portion 7002 is inserted into the bone portion and then it is determined (e.g., using image data from step 7510) that the position of the pin portion within the bone portion is an appropriate position for placing at least a portion of an implant, in step 7515 the same pinning and drilling instrument can be further inserted into the same location of the bone portion where the pin portion 7002 was positioned to insert the drill portion 7004 into the same location of the bone portion and create an implant receiving opening 7051, thereby creating a tacking opening 7050 so that an implant receiving opening can subsequently be created.

[0285] 22C is a side view of two pinning and drilling instruments 7000 after the respective pin portion of each pinning and drilling instrument 7000 has been inserted a first distance into the respective bone portion 1604, 1606, and each has then been inserted a second, further distance into the respective bone portion 1604, 1606. By inserting each pinning and drilling instrument 7000 a second, further distance into the respective bone portion 1604, 1606 so that the drill portion 7004 of each pinning instrument 7000 is inserted into the respective bone portion 1604, 1606, two implant-receiving openings 7051 can be created—one implant-receiving opening in the bone portion 1604 using the drill portion 7004 of one of the pinning and drilling instruments 7000, and another implant-receiving opening in the bone portion 1606 using the drill portion 7004 of the other pinning and drilling instrument 7000. The distance that one created implant receiving opening in bone portion 1604 extends into the bone may generally be equal to or may approximate the length of the first leg of the staple on the first side of the staple bridge, and the distance that the other created implant receiving opening in bone portion 1606 extends into the bone may generally be equal to or may approximate the length of the second leg of the staple on the second side of the staple bridge.

[0286] In step 7515, while the pin portion 7002 is in the bone, the pinning and drilling instrument 7000 can be inserted further into the bone a second further distance to create an implant-receiving opening 7051 at the location of the pin portion 7002 insertion in the bone. For example, inserting the pinning and drilling instrument 7000 a second further distance into the bone can cause the pin portion 7002 to be inserted further into the bone while the drill portion 7004 contacts the bone where the pin portion 7002 previously contacted the bone (e.g., at the tacking opening 7050). As mentioned above, in some examples, the drill portion 7004 can include a drill flute that begins where the pin portion 7002 ends, and in such examples, inserting the pinning and drilling instrument 7000 a second further distance into the bone in step 7515 can include rotationally driving the drill flute of the pin portion 7004 to the location of the bone where the pin portion was inserted into the bone (rotationally driving the drill flute at the tacking opening 7050). In embodiments in which the drill portion 7004 includes a larger diameter than the pin portion 7002, creating an implant receiving opening 7051 at the location where the pin portion 7002 is inserted by rotationally driving the drill grooves of the drill portion into the bone at that location can include creating an implant receiving opening 7051 of a second diameter extending into the bone at the location where the pin portion 7002 was inserted, and thus the tacking opening 7050 of the first diameter, where the second diameter of the implant receiving opening 7051 is larger than the first diameter of the tacking opening 7050.

[0287] 23C illustrates application of step 7515 of exemplary technique 7500 using a drill guide 2040 positioned on bone portions 1604, 1606. In such an example, step 7515 may be performed to insert the pinning and drilling instrument 7000 a second additional distance into the bone portion through the drill guide 2040, with the drill portion 7004 extended from the drill guide 2040 to create an implant-receiving opening 7051 where the pin portion 7002 was inserted. This may include inserting the pinning and drilling instrument 7000 a second additional distance into the bone portion through a guide sleeve 2041 or 2042 of the drill guide 2040, with the drill portion 7004 extended from the drill guide 2041 or 2042 to create the implant-receiving opening 7051 where the pin portion 7002 was inserted.

[0288] At step 7520, technique 7500 includes positioning an implant in implant receiving opening 7051. For example, positioning the implant in implant receiving opening 7051 may include positioning a portion of the implant within implant receiving opening 7051. For example, at least a portion of the implant positioned in implant receiving opening 7051 can have a length of the implant portion equal to the length of the implant receiving opening 7051 created in step 7515 using drill portion 7004 (e.g., the length of the implant portion can be equal to the length of drill portion 7004). As a further example, at least a portion of the implant positioned in implant receiving opening 7051 can be larger than the first diameter of tacking opening 7050 created in step 7505 using pin portion 7002, but smaller than the implant receiving opening 7051 created in step 7515 using drill portion 7004.

[0289] As one example for performing step 7520, the implant can be a staple having a first leg, a second leg, and a bridge bridging the first and second legs, where bone portion 1604 can be a first bone (e.g., a metatarsal bone) and bone portion 1606 can be a second bone (e.g., a cuneiform bone). In this example, the first implant-receiving opening can be created in step 7515 to have a length approximately equal to the length of the first leg of the staple and a diameter greater than the diameter of the first leg of the staple. Similar to this example, the second implant-receiving opening can be created in step 7515 to have a length approximately equal to the length of the second leg of the staple and a diameter greater than the diameter of the second leg of the staple. Next, in this example, placing the staple in step 7520 may include placing a first leg of the staple in a first implant-receiving opening created with the drill portion 7004 of one of the pinning and punching instruments 7000, and placing a second leg of the staple in a second implant-receiving opening created with the drill portion 7004 of the other of the pinning and punching instruments 7000.

[0290] 23 is an elevational view of another embodiment of a pinning and drilling instrument 7600 used in combination with a power driver (e.g., a power drill) 7690 and a drill guide 2040. The pinning and drilling instrument 7600 may be similar to or the same as the pinning and drilling instrument 7000 disclosed elsewhere herein, except as otherwise disclosed herein.

[0291] For example, the pinning and piercing instrument 7600 can have one or more of the features disclosed elsewhere herein with respect to the pinning and piercing instrument 7000, except that the pinning and piercing instrument 7600 can have variable stiffness along its length. Specifically, the pinning and piercing instrument 7600 can include one end that is less stiff and therefore more flexible than the opposing end. For example, the pinning and piercing instrument 7600 can have a proximal portion that is less stiff and therefore more flexible than a distal portion of the pinning and piercing instrument 7600. The illustrated embodiment of the pinning and drilling instrument 7600 shows a driver engagement portion 7615 that is proximal to the drill portion 7004 and proximal to the pin portion 7002, and the illustrated embodiment also shows that the driver engagement portion 7615 may have a lower stiffness and therefore may be more flexible than the drill portion 7004 and / or the pin portion 7002 (e.g., the drill portion 7004 and the pin portion 7002 have a greater flexural modulus than the driver engagement portion 7615). Thus, the distal end of the body of the pinning and drilling instrument 7600 having the driver engagement portion 7615 may be less stiff and therefore more flexible than the proximal end of the body of the pinning and drilling instrument 7600 having the pin and / or drill portions 7002, 7004.

[0292] Variable stiffness along the length of the pinning and drilling instrument 7600 can be useful to create clearance space for a user to maneuver during a procedure involving the pinning and drilling instrument 7600. Figure 23 shows the pinning and drilling instrument 7600 adjacent to a drill guide 2040 and to a powered driver 7690 that engages an adjacent drill piece in the drill guide 2040. As can be seen here, the more flexible distal end of the body of the pinning and drilling instrument 7600, having a driver engagement portion 7615, can be configured to bend and flex away from the powered driver 7690 that also engages the adjacent drill piece in the drill guide 2040. 23 , the more flexible distal end of the body of the pinning and drilling instrument 7600 can be configured to bend and flex away from the powered driver 7690, while the stiffer proximal end of the body of the pinning and drilling instrument 7600 having the pin portion 7002 and the drill portion 7004 can be configured to maintain a linear and straight orientation. Thus, the stiffer proximal end of the body of the pinning and drilling instrument 7600 having the pin portion 7002 and the drill portion 7004 can extend along one longitudinal axis, while the less stiff distal end of the body of the pinning and drilling instrument 7600 having the driver engagement portion 7615 can extend along another longitudinal axis that is at an oblique orientation relative to the longitudinal axis along which the pin portion 7002 and the drill portion 7004 can extend.

[0293] In addition to the variable stiffness along the length of the pinning and drilling instrument 7600, the pinning and drilling instrument 7600 can define the same diameter at the pin portion 7002 as the driver engagement portion 7615. This common diameter at the pin portion and the driver engagement portion 7615 of the pinning and drilling instrument 7600 can be useful in reducing or eliminating the need to switch collet connection components on the powered driver 7690.

[0294] 24-26 illustrate additional embodiments of the pinning and drilling instrument having various pin and drill portion configurations. Any of the pin and drill portion configurations shown in the examples of Figures 24-26 can be used with any other pinning and drilling instrument embodiment disclosed herein.

[0295] 24 is a perspective view of the distal end of an additional embodiment of a pinning and piercing instrument 7700. The pinning and piercing instrument 7700 can be similar to or the same as any other pinning and piercing instrument disclosed elsewhere herein (e.g., pinning and piercing instrument 7000, pinning and piercing instrument 7600), except as otherwise disclosed herein.

[0296] 24 , the pinning and drilling instrument 7700 can have a pin portion 7002 and a drill portion 7004. The illustrated pinning and drilling instrument 7700 can be similar to or identical to the pinning and drilling instrument 7000 previously described herein, except that, as shown in the example of FIG. 24 , the pinning and drilling instrument 7700 can lack any grooves in the drill portion 7004. Specifically, the pinning and drilling instrument 7700 can have both the pin portion 7002 and the drill portion 7004 without any grooves. Thus, the pin portion 7002 of the pinning and drilling instrument 7700 can include a planar, ungrooved surface extending circumferentially around the outer periphery of the pin portion 7002, and the drill portion 7004 of the pinning and drilling instrument 7700 can include a planar, ungrooved surface extending circumferentially around the outer periphery of the drill portion 7004. If the drill portion 7004 of the pinning and drilling instrument 7700 does not have grooves, the drill portion 7004 of the pinning and drilling instrument 7700 cannot be configured to drill an implant-receiving hole in bone, but instead the pinning and drilling instrument 7700 can be configured to provide a tacking function using the drill portion 7002.

[0297] 25 is a perspective view of the distal end of a further embodiment of a pinning and piercing instrument 7800. The pinning and piercing instrument 7800 can be similar to or the same as any other pinning and piercing instrument disclosed elsewhere herein (e.g., pinning and piercing instrument 7000, pinning and piercing instrument 7600), except as otherwise disclosed herein.

[0298] At its distal end, as shown in FIG. 25 , the pinning and drilling instrument 7800 can have a pin portion 7002 and a drill portion 7004. The illustrated pinning and drilling instrument 7800 can be similar to or identical to the pinning and drilling instrument 7000 previously described herein, except that, as shown in the example of FIG. 25 , the pinning and drilling instrument 7800 can include one or more grooves 7005 in each of the pin portion 7002 and the drill portion 7004. As shown in FIG. 25 , the pin portion 7002 of the pinning and drilling instrument 7800 can include one or more grooves 7005 extending along at least a portion of the length 7010 of the pin portion 7002. The one or more grooves 7005 in the pin portion 7002 can extend along at least a portion of the length 7010 of the pin portion 7002 and around at least a portion of the circumference (e.g., diameter) of the pin portion 7002. In addition to the tacking function, the pin portion 7002 of the pinning and drilling instrument 7800 may be configured so that the presence of one of a number of grooves 7005 therein helps create an implant-receiving opening in the bone (e.g., for receiving a portion of an implant, such as a staple leg) by fracturing a portion of the bone when / if the pinning and drilling instrument 7800 is rotationally driven when the pin portion 7002 is in contact with the bone. Also, as also shown in FIG. 25 , the drill portion 7004 of the pinning and drilling instrument 7800 may include one or more grooves 7005 extending along the length 7011 of the drill portion 7004 and around at least a portion of the outer periphery (e.g., circumference) of the drill portion 7004. Thus, when the pinning and drilling instrument 7800 is rotationally driven while the drill portion 7004 is in contact with bone, the drill portion 7004 can be configured to fracture a portion of the bone using the grooves 7005 to help create an implant-receiving opening in the bone.

[0299] 26 is a perspective view of the distal end of another embodiment of a pinning and piercing instrument 7900. The pinning and piercing instrument 7900 can be similar to or the same as any other pinning and piercing instrument disclosed elsewhere herein (e.g., pinning and piercing instrument 7000, pinning and piercing instrument 7600), except as otherwise disclosed herein.

[0300] 26 , the pinning and drilling instrument 7900 can have a pin portion 7002 and a drill portion 7004. The illustrated pinning and drilling instrument 7900 can be similar to or identical to the pinning and drilling instrument 7000 previously described herein, except that the pinning and drilling instrument 7900 can include one or more grooves 7005 in the pin portion 7002 and / or the drill portion 7004 and can include one or more threads 7090 in the pin portion 7002 and / or the drill portion 7004. As shown in FIG. 26 , the pin portion 7002 of the pinning and drilling instrument 7900 can include one or more threads 7090. The threads 7090 in the pin portion 7002 can extend along at least a portion of the length 7010 of the pin portion 7002 (e.g., along at least half of the length 7010) and around at least a portion of the circumference (e.g., diameter) of the pin portion 7002. The threads 7090 on the pin portion 7002 can be configured to create a threaded surface in a bone, such as, for example, a location in the bone where an implant will be placed after use of the pinning and drilling tool 7900, when / if the pin portion 7002 is in contact with the bone, and the pinning and drilling tool 7900 is rotationally driven. In certain examples, in addition to the one or more threads 7090, the pin portion 7002 of the pinning and drilling tool 7900 can include one or more grooves 7005. As also shown in FIG. 26 , the drill portion 7004 of the pinning and drilling tool 7900 can include one or more grooves 7005 extending along the length 7011 of the drill portion 7004 and around at least a portion of the outer periphery (e.g., circumference) of the drill portion 7004. Thus, when the pinning and drilling instrument 7900 is rotationally driven while the drill portion 7004 is in contact with bone, the drill portion 7004 can be configured to fracture a portion of the bone using the grooves 7005 to help create an implant-receiving opening in the bone.

[0301] 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.

[0302] Various examples have been described. These and other examples are within the scope of the following claims.

Claims

1. 1. A system comprising: a contour guide including a contour guide body having an upper side and a lower side, the lower side configured to interface with a first bone, a second bone, and a separation between the first bone and the second bone, the lower side including a guide slot defining a guide slot cross-sectional area, the guide slot cross-sectional area configured to receive a bone surface modifying instrument to modify a surface area of ​​at least one of the first bone and the second bone to form a modified surface area on one or both of the first bone and the second bone; the system including an implant guide sleeve defining an interior cross-sectional area greater than a cross-sectional area of ​​the guide slot, the interior area of ​​the implant guide sleeve configured to receive the underside of the contour guide body to guide placement and to interface with the first bone, the second bone, and the separation between the first bone and the second bone.

2. 10. The system of claim 9, wherein the contour guide body further comprises at least one guide opening extending from the upper side through at least a portion of the contour guide body, the at least one guide opening being axially aligned with the guide slot, the at least one guide opening being configured to at least partially receive the bone surface modifying instrument.

3. 10. The system of claim 9, wherein the at least one guide opening includes a first guide opening and a second guide opening spaced apart from the first guide opening, the first guide opening extending from the upper side through at least a portion of the contour guide body in a first oblique direction and the second guide opening extending from the upper side through at least a portion of the contour guide body in a second oblique direction different from the first oblique direction, and wherein each of the first guide opening and the second guide opening is configured to receive the bone surface modifying instrument.

4. 10. The system of claim 9, wherein the inner region of the implant guide sleeve is further configured to (i) guide the creation of a first implant hole in the modified surface area of ​​a first bone and the creation of a second implant hole in the modified surface area of ​​a second bone, and (ii) guide the placement of a first leg of an implant in the first implant hole in the modified surface area of ​​the first bone and the placement of a second leg of the implant in the second implant hole in the modified surface area of ​​the second bone.

5. 1. A method of modifying a bone surface to receive an implant, said method comprising: positioning a contour guide at a first bone and a second bone across a separation between the first bone and the second bone; modifying a surface region of at least one of the first bone and the second bone using the contour guide to form a modified surface region on one or both of the first bone and the second bone; positioning an implant in contact with at least the modified surface area.

6. using the contour guide to modify the surface region of at least one of the first bone and the second bone includes using the contour guide to modify a first surface region on the first bone to form a modified first surface region along the first bone, and a second surface region on the second bone to form a modified second surface region along the second bone; 10. The method of claim 1, wherein positioning the implant in contact with at least the modified surface area comprises placing the implant in contact with each of the modified first surface area and the modified second surface area.

7. the implant has an implant length; the modified first surface area and the modified second surface area define a length of a modified bone surface along the first bone and the second bone; 10. A method according to any one of the preceding claims, wherein the length of the modified bone surface is equal to or greater than the length of the implant.

8. the implant is a staple; the first bone is a metatarsal, the second bone is a cuneiform, and the separation between the metatarsal and the cuneiform is a joint space between the metatarsal and the cuneiform; 10. The method of claim 9, wherein positioning the implant in contact with at least the modified surface area comprises placing a first leg of the staple through the modified first surface area at a metatarsal bone and placing a second leg of the staple through the modified second surface area at a cuneiform bone.

9. 10. The method of claim 9, wherein the implant is placed in contact with each of the modified first surface area and the modified second surface area, and the implant bridges the separation between the first bone and the second bone.

10. 10. The method of claim 9, wherein modifying the surface region of at least one of the first bone and the second bone using the contour guide to form the modified surface region on one or both of the first bone and the second bone comprises positioning a bone surface modifying instrument on the contour guide and contacting the surface region of at least one of the first bone and the second bone.

11. 10. The method of claim 9, wherein the bone surface modifying tool positioned on the contour guide and in contact with the surface region of at least one of the first bone and the second bone is configured to fracture bone at the surface region of at least one of the first bone and the second bone.

12. 10. The method of claim 1, wherein the bone surface modifying tool positioned on the contour guide and brought into contact with the surface region of at least one of the first bone and the second bone comprises at least one of a burr and a saw.

13. the contour guide includes a contour guide body having an upper side and a lower side; the underside includes a guide slot defining a guide slot cross-sectional area that is greater than a cross-sectional area of ​​the implant; 10. The method of claim 1, wherein positioning the contour guide comprises positioning the underside of the contour guide against the first bone and the second bone and across a separation between the first bone and the second bone.

14. 10. The method of claim 9, wherein positioning the underside of the contour guide on the first bone and the second bone and across the separation between the first bone and the second bone comprises positioning the guide slot on the first bone and the second bone and across the separation between the first bone and the second bone.

15. the contour guide body includes a guide opening; 10. The method of claim 9, wherein modifying the surface area of ​​at least one of the first bone and the second bone using the contour guide to form the modified surface area on one or both of the first bone and the second bone comprises positioning a bone surface modifying instrument at least partially in the guide opening and at least partially in the guide slot and contacting the surface area of ​​at least one of the first bone and the second bone.

16. the guide opening is aligned with the guide slot; 10. The method of claim 9, wherein the contour guide is positioned on the first bone and the second bone and across the separation between the first bone and the second bone, and the bone surface modifying instrument is inserted first into the guide opening, then into the guide slot, and then placed in contact with the surface region of at least one of the first bone and the second bone to modify the surface region of at least one of the first bone and the second bone.

17. 10. The method of claim 9, further comprising positioning an implant guide sleeve on the first bone and the second bone and across the separation between the first bone and the second bone, wherein the contour guide is positioned on the first bone and the second bone and across the separation between the first bone and the second bone using the implant guide sleeve.

18. 10. The method of claim 9, further comprising fixing the implant guide sleeve to the first bone and the second bone before positioning the contour guide with the implant guide sleeve on the first bone and the second bone and across the separation between the first bone and the second bone.

19. 10. The method of claim 9, wherein modifying the surface area of ​​at least one of the first bone and the second bone using the contour guide to form the modified surface area on one or both of the first bone and the second bone comprises modifying the surface area using the contour guide while the contour guide is at least partially positioned within the implant guide sleeve.

20. 10. The method of claim 9, further comprising: after positioning the contour guide using the implant guide sleeve and modifying the surface area of ​​at least one of the first bone and the second bone using the contour guide to form the modified surface area in one or both of the first bone and the second bone, advancing an inserter operatively connected to the implant relative to the implant guide sleeve to position the implant in contact with at least the modified surface area.

21. 1. A method for placing an implant in one or more bone portions, the method comprising: placing a trial member in the one or more bone portions, the trial member simulating configuration of the implant in the one or more bone portions; determining the relative fit of the trial member on the one or more bone portions; after placing the trial members in the one or more bone portions, creating one or more implant-receiving openings at the one or more bone portions where the trial members were placed; and placing the implant into the one or more created implant-receiving openings.

22. 10. The method of the preceding claim, wherein the implant is a staple and the trial member simulates at least one dimension of the staple.

23. 10. The method of any one of the preceding claims, wherein the trial member includes a trial bridge defining a trial arch, the trial arch corresponding to the arch defined by the bridge of the staple.

24. 10. The method of claim 1, wherein determining the relative fit of the trial members in the one or more bone portions comprises determining the fit of the trial arch in the one or more bone portions.

25. 1. A pinning and piercing device comprising: a body having a proximal body end and a distal body end; a pin portion at the distal end of the body and extending proximally along a length of the pin portion of the body toward the proximal end of the body, the length of the pin portion being equal to a length of a portion of the implant that is to be implanted in bone, the pin portion defining a first width in the body, the pin portion configured to create a tacking opening in the bone; and 10. The pinning and drilling instrument, comprising: a drill portion including drill flutes, the drill portion being proximal to the pin portion of the body, the drill flutes beginning where the pin portion ends, the drill portion defining a second width in the body that is greater than the first width, the drill flutes configured to create an implant-receiving opening in the bone after the tacking opening is created, at least at the location in the bone where the tacking opening was created.

26. 10. An instrument according to any one of the preceding claims, further comprising a visual indicator on the body proximal to the pin and drill portions, the visual indicator being at a location along the length of the body corresponding to a fully inserted position of the pin portion.

27. 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 implant guide sleeve defining an interior region configured to (i) guide the creation of a first implant hole in a first bone and a second implant hole in a second bone, and (ii) guide the placement of the first leg of the staple in the first implant hole in the first bone and the second leg of the staple in the second implant hole in the second bone; and the system comprising 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 join the first coupling shaft and the second coupling shaft.

28. the connector includes a first receptacle configured to receive the first coupling shaft and a second receptacle configured to receive the second coupling shaft; 10. The system of claim 9, wherein the first receptacle and the second receptacle are spaced apart around the connector such that when the connector is aligned with the implant guide sleeve, each of the first receptacle and the second receptacle is aligned with the interior region of the implant guide.

29. 10. The system of claim 9, wherein the first receptacle and the second receptacle are spaced apart around the connector such that when the connector is aligned with the implant guide sleeve, each of the first receptacle and the second receptacle is aligned within an envelope of the interior region of the implant guide.

30. 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; 10. The system of any one of the preceding claims, wherein 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.

31. 10. The system of claim 1, wherein the implant guide sleeve further comprises a first pin opening configured to receive a first pin positioned therein through the first bone to secure the implant guide sleeve to the first bone, and a second pin opening configured to receive a second pin positioned therein through the second bone to secure the implant guide sleeve to the second bone.

32. the implant guide sleeve includes a first end lower surface, a second end lower surface spaced apart from the first end lower surface, a first end upper surface aligned with the first end lower surface, and a second end upper surface aligned with the second end lower surface and spaced apart from the first end upper surface; the implant guide sleeve is configured to be placed on the first bone and the second bone such that an undersurface of the first end of the implant guide sleeve contacts the first bone and an undersurface of the second end of the implant guide sleeve contacts the second bone; 10. The system of claim 1, wherein the implant guide sleeve is configured to guide the staple and the inserter to advance between the first end upper surface and the second end upper surface and toward the first end lower surface and the second end lower surface, such that the staple is adjacent the first end lower surface and the second end lower surface when the staple contacts the first bone and the second bone.

33. 10. The system of claim 1, wherein the interior region of the implant guide sleeve is configured to receive a drill therein to guide creation of the first implant hole in the first bone and the second implant hole in the second bone.

34. 10. The system of claim 1, further comprising a drill guide, the interior region of the implant guide sleeve configured to receive the drill guide and guide placement of the drill guide in the first bone and the second bone.

35. 10. The system of any one of the preceding claims, wherein the drill guide includes a first drill guide sleeve configured to guide drilling of the first implant hole and a second drill guide sleeve configured to guide drilling of the second implant hole.

36. 10. The system of claim 9, wherein the implant guide sleeve has at least one side wall defining an interior region, and the drill guide defines a periphery size and shape indexed to the interior region of the implant guide sleeve.

37. 10. The system of any one of the preceding claims, wherein the drill guide is removably coupled to the implant guide sleeve.

38. 10. The system of claim 1, wherein the drill guide further includes a handle, the handle extending at least partially outside the interior region when each of the first drill guide sleeve and the second drill guide sleeve is received within the interior region of the implant guide sleeve.

39. 10. The system of any one of the preceding claims, wherein the implant guide sleeve is configured to adjust the size of the interior region between a first size configuration and a second size configuration.

40. 10. The system of claim 1, wherein the first size configuration of the internal region defines a first internal cross-sectional area bounded by the implant guide sleeve, and the second size configuration of the internal region defines a second internal cross-sectional area bounded by the implant guide sleeve, the second internal cross-sectional area being larger than the first internal cross-sectional area.

41. 10. The system of claim 1, wherein the implant guide sleeve includes a first guide arm and a second guide arm, and the implant guide sleeve is configured to adjust the size of the internal region between the first size configuration and the second size configuration by rotating the first guide arm and rotating the second guide arm.

42. the implant guide sleeve includes a handle; the first guide arm is rotatably coupled to the handle, and the second guide arm is rotatably coupled to the handle; 10. The system of claim 1, wherein the implant guide sleeve is configured to adjust the size of the interior region between the first size configuration and the second size configuration by rotating the first guide arm relative to the handle and rotating the second guide arm relative to the handle.

43. In the first size configuration, the first guide arm and the second guide arm are spaced apart a first guide arm distance; 10. The system of claim 1, wherein in the second size configuration, the first guide arm and the second guide arm are spaced apart by a second guide arm distance that exceeds the first guide arm distance.

44. 10. The system of any one of the preceding claims, wherein the drill guide is movably coupled to the implant guide sleeve.

45. 10. The system of any one of the preceding claims, wherein the drill guide includes a first drill guide sleeve movable relative to the implant guide sleeve, and a second drill guide sleeve movable relative to the implant guide sleeve.

46. the drill guide is movable relative to the implant guide sleeve between a retracted position and an extended position; In the retracted position, each of the first drill guide sleeve and the second drill guide sleeve is retracted relative to the implant guide sleeve; 10. The system of claim 1, wherein in the extended position, each of the first and second drill guide sleeves is aligned with the implant guide sleeve.

47. 10. The system of claim 1, wherein in the extended position, the first drill guide sleeve and the second drill guide sleeve are each located within the interior region defined by the implant guide sleeve.

48. the implant guide sleeve includes a first guide arm and a second guide arm; 10. The system of claim 1, wherein the first guide arm includes a first inner surface having a first geometric shape complementary to the first drill guide sleeve and the second guide arm includes a second inner surface having a second geometric shape complementary to the second drill guide sleeve, wherein in the extended position of the first drill guide sleeve the first drill guide sleeve nests on the first inner surface and in the extended position the second drill guide sleeve of the second drill guide sleeve nests on the second inner surface.

49. the implant guide sleeve includes a handle, a first guide arm, and a second guide arm; the first guide arm is rotatably coupled to the handle, and the second guide arm is rotatably coupled to the handle; 10. The system of claim 1, wherein the implant guide sleeve is configured to adjust the size of the interior region between the first size configuration and the second size configuration by rotating the first guide arm relative to the handle and rotating the second guide arm relative to the handle.

50. the handle includes an actuator configured to move the drill guide relative to the implant guide sleeve from a retracted position to an extended position; In the retracted position, each of the first drill guide sleeve and the second drill guide sleeve is retracted relative to the implant guide sleeve; 10. The system of claim 1, wherein in the extended position, each of the first and second drill guide sleeves is aligned with the implant guide sleeve.

51. the drill guide includes a visual marker for alignment with a space separating the first bone from the second bone; In the retracted position, the visual marker is retracted relative to the implant guide sleeve; 10. The system of claim 1, wherein in the extended position, the visual marker is aligned with the implant guide sleeve.

52. the staple includes an upper surface and a lower surface; the inserter is operatively connected to the staple at a location of the staple spaced from the lower surface; 10. The system of any one of the preceding claims, wherein the underside of the staple is configured to contact the first bone and the second bone.

53. 10. The system of any one of the preceding claims, wherein the inserter is operatively connected to the staple at a location of the staple between the upper surface and the lower surface, the staple configured to bring the first bone into flush contact with the lower surface and the second bone into flush contact with the lower surface.

54. 10. The system of any one of the preceding claims, 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 staple is configured to bridge across the tarsometatarsal joint space.

55. 1. A method of fixing bones for fusion, said method comprising: positioning an implant guide sleeve on a first bone, a second bone, and across a separation between the first bone and the second bone; using the implant guide sleeve to guide the creation of a first implant hole in the first bone and to guide the creation of a second implant hole in the second bone; aligning an inserter operably connected to an implant with the implant guide sleeve; and advancing the inserter relative to the implant guide sleeve to position the implant in contact with the first bone and the second bone, so that the implant bridges between the first bone and the second bone.

56. 10. The method of claim 9, further comprising securing the implant guide sleeve to each of the first bone and the second bone.

57. 10. The method of claim 1, wherein the implant guide sleeve is secured to each of the first bone and the second bone before advancing the inserter relative to the implant guide sleeve to position the implant.

58. 10. The method of claim 1, wherein fixing the implant guide sleeve to the first bone comprises inserting a first pin into the first bone through a first pin opening in the implant guide sleeve, and fixing the implant guide sleeve to the second bone comprises inserting a second pin into the second bone through a second pin opening in the implant guide sleeve.

59. the implant guide sleeve includes a first end lower surface, a second end lower surface spaced apart from the first end lower surface, a first end upper surface aligned with the first end lower surface, and a second end upper surface aligned with the second end lower surface and spaced apart from the first end upper surface; positioning the implant guide sleeve in the first bone and the second bone includes contacting the first bone with an underside of the first end of the implant guide sleeve and contacting the second bone with an underside of the second end of the implant guide sleeve; 10. The method of claim 9, wherein advancing the inserter relative to the implant guide sleeve comprises advancing the implant and the inserter between the first and second upper end surfaces and toward the first and second lower end surfaces so that the implant contacts the first and second bones and is adjacent the first and second lower end surfaces when the implant bridges the first and second bones.

60. 10. The method of claim 9, wherein advancing the inserter relative to the implant guide sleeve to position the implant in contact with the first bone and the second bone so that the implant bridges the first bone and the second bone comprises advancing the inserter relative to the implant guide sleeve to position the implant in the first implant hole in the first bone and in the second implant hole in the second bone across the separation.

61. 10. The method of claim 9, wherein using the implant guide sleeve to guide the creation of the first implant hole in the first bone and the creation of the second implant hole in the second bone comprises using the implant guide sleeve to guide the placement of drills in the first bone and the second bone to create the first implant hole and the second implant hole.

62. 10. The method of claim 9, wherein using the implant guide sleeve to guide placement of the drill in the first bone and the second bone comprises using an interior region defined by the implant guide sleeve to guide placement of the drill in the first bone to create the first implant hole and to guide placement of the drill in the second bone to create the second implant hole.

63. 10. The method of claim 9, wherein using the implant guide sleeve to guide the creation of the first implant hole in the first bone and the second implant hole in the second bone comprises inserting a drill guide into the implant guide sleeve and drilling the first implant hole in the first bone and the second implant hole in the second bone via the drill guide inserted into the implant guide sleeve.

64. 10. The method of any one of the preceding claims, wherein the drill guide comprises a first drill guide sleeve and a second drill guide sleeve, and further comprising drilling the first implant hole in the first bone using the first drill guide sleeve and drilling the second implant hole in the second bone using the second drill guide sleeve.

65. 10. The method of claim 9, wherein the implant guide sleeve has at least one sidewall defining an interior region, and the drill guide defines a periphery size and shape indexed to the interior region of the implant guide sleeve.

66. aligning the drill guide with the implant guide sleeve; and 10. The method of any one of the preceding claims, further comprising placing the drill guide in the implant guide sleeve.

67. Disposing the drill guide in the implant guide sleeve comprises: positioning the first drill guide sleeve within an interior region defined by the implant guide sleeve; positioning the second drill guide sleeve within the interior region defined by the implant guide sleeve; and 10. The method of any one of the preceding claims, comprising positioning a handle of the drill guide at least partially outside the interior region defined by the implant guide sleeve.

68. 10. The method of any one of the preceding claims, further comprising adjusting the size of the implant guide sleeve between a first size configuration and a second size configuration.

69. 10. The method of claim 9, wherein the first size configuration of the implant guide sleeve defines a first internal cross-sectional area bounded by the implant guide sleeve, and the second size configuration of the implant guide sleeve defines a second internal cross-sectional area bounded by the implant guide sleeve, the second internal cross-sectional area being larger than the first internal cross-sectional area.

70. inserting the implant guide sleeve in the first size configuration through an incision exposing at least a portion of each of the first bone, the second bone, and the separation before positioning the implant guide sleeve on the first bone, the second bone, and across the separation; and 10. The method of any one of the preceding claims, further comprising, after inserting the implant guide sleeve in the first size configuration through the incision, adjusting the size of the implant guide sleeve from the first size configuration to the second size configuration.

71. 10. The method of any one of the preceding claims, wherein the implant guide sleeve is adjusted from the first size configuration to the second size configuration before advancing the inserter relative to the guide sleeve.

72. 10. The method of claim 9, further comprising securing the implant guide sleeve to each of the first bone and the second bone after adjusting the implant guide sleeve from a first size configuration to the second size configuration and before advancing the implant guide sleeve relative to the guide sleeve.

73. 10. The method of claim 1, wherein the implant guide sleeve includes a first guide arm and a second guide arm, and adjusting the size of the implant guide sleeve between the first size configuration and the second size configuration includes rotating the first guide arm and rotating the second guide arm.

74. the implant guide sleeve includes a handle; the first guide arm is rotatably coupled to the handle, and the second guide arm is rotatably coupled to the handle; 10. The method of claim 1, wherein adjusting the size of the implant guide sleeve between the first size configuration and the second size configuration comprises rotating the first guide arm relative to the handle and rotating the second guide arm relative to the handle.

75. In the first size configuration, the first guide arm and the second guide arm are spaced apart a first guide arm distance; 10. The method of claim 1, wherein in the second size configuration, the first guide arm and the second guide arm are spaced apart by a second guide arm distance that exceeds the first guide arm distance.

76. 10. The method of any one of the preceding claims, wherein the drill guide is removably coupled to the implant guide sleeve.

77. 10. The method of claim 1, further comprising inserting the implant guide sleeve in the first size configuration through an incision exposing at least a portion of each of the first bone, the second bone, and the separation, and then moving the drill guide relative to the implant guide sleeve.

78. 10. The method of claim 1, wherein the drill guide is moved relative to the implant guide sleeve after adjusting the size of the implant guide sleeve between the first size configuration and the second size configuration.

79. 10. The method of any one of the preceding claims, wherein the drill guide comprises a first drill guide sleeve movable relative to the implant guide sleeve, and a second drill guide sleeve movable relative to the implant guide sleeve.

80. the drill guide is movable relative to the implant guide sleeve between a retracted position and an extended position; In the retracted position, each of the first drill guide sleeve and the second drill guide sleeve is retracted relative to the implant guide sleeve; 10. The method of claim 1, wherein in the extended position, each of the first and second drill guide sleeves is aligned with the implant guide sleeve.

81. 10. The method of claim 1, wherein in the extended position, the first drill guide sleeve and the second drill guide sleeve each lie within an interior region defined by the implant guide sleeve.

82. the implant guide sleeve includes a first guide arm including a first inner surface and a second guide arm including a second inner surface; 10. The method of claim 1, wherein the first inner surface of the first guide arm has a first geometric shape complementary to the first drill guide sleeve and the second inner surface of the second guide arm has a second geometric shape complementary to the second drill guide sleeve, wherein in the extended position of the first drill guide sleeve the first drill guide sleeve nests on the first inner surface and in the extended position the second drill guide sleeve of the second drill guide sleeve nests on the second inner surface.

83. 10. The method of any one of the preceding claims, further comprising actuating an actuator on a handle of the implant guide sleeve to move the drill guide relative to the implant guide sleeve from the retracted position to the extended position.

84. the drill guide includes a visual marker for alignment with the separation between the first bone and the second bone; In the retracted position, the visual marker is retracted relative to the implant guide sleeve; 10. The method of any one of the preceding claims, wherein in the extended position, the visual marker is aligned with the implant guide sleeve.

85. 10. The method of claim 1, wherein the implant is a staple including a first leg and a second leg separated from each other by a bridge, and wherein advancing the inserter relative to the implant guide sleeve to position the implant in contact with the first bone and the second bone includes positioning the first leg of the staple in the first implant hole in the first bone and positioning the second leg of the staple in the second implant hole in the second bone.

86. 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; 10. The method of any one of the preceding claims, wherein the connector couples the first coupling shaft and the second coupling shaft.

87. 10. The method of any one of the preceding claims, further comprising, after advancing the inserter relative to the implant guide sleeve to position the implant in contact with the first bone and the second bone, removing the connector, thereby moving the first coupling shaft and the second coupling shaft away from each other.

88. 10. The method of any one of the preceding claims, 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.

89. 10. The method of any one of the preceding claims, wherein the first coupling shaft and the second coupling shaft define opposite ends of the implant, and the connector includes caps positioned over the ends of the first coupling shaft and the second coupling shaft.

90. 10. The method of any one of the preceding claims, wherein the first bone is a metatarsal, the second bone is a cuneiform, and the separation is a tarsometatarsal joint space between the metatarsal and the cuneiform.

91. the implant includes an upper surface and a lower surface; the inserter is operably connected to the implant at a location of the implant spaced from the undersurface; 10. The method of claim 1, wherein advancing the inserter relative to the implant guide sleeve to position the implant in contact with the first bone and the second bone comprises contacting the first bone and the second bone with the underside of the implant.

92. 10. The method of any one of the preceding claims, wherein the inserter is operatively connected to the implant at a location of the implant between the upper surface and the lower surface, and wherein contacting the first bone and the second bone with the lower surface of the implant comprises contacting the first bone flush with the lower surface and contacting the second bone flush with the lower surface.

93. 1. A method of modifying a bone surface to receive an implant, said method comprising: positioning a contour guide at a first bone and a second bone across a separation between the first bone and the second bone; modifying a surface region of at least one of the first bone and the second bone using the contour guide to form a modified surface region on one or both of the first bone and the second bone; positioning an implant in contact with at least the modified surface area.

94. using the contour guide to modify the surface region of at least one of the first bone and the second bone includes using the contour guide to modify a first surface region on the first bone to form a modified first surface region along the first bone, and a second surface region on the second bone to form a modified second surface region along the second bone; 10. The method of claim 1, wherein positioning the implant in contact with at least the modified surface area comprises placing the implant in contact with each of the modified first surface area and the modified second surface area.

95. 10. The method of claim 9, wherein the implant has an implant length, and the modified first surface area and the modified second surface area define a length of a modified bone surface along the first bone and the second bone, and the length of the modified bone surface is equal to or greater than the length of the implant.

96. 10. The method of claim 9, wherein the implant is a staple, the first bone is a metatarsal, the second bone is a cuneiform, the separation between the first bone and the second bone is a joint space between the metatarsal and the cuneiform, and contacting the implant with at least the modified surface area to position a first leg of the staple through the modified first surface area of ​​the metatarsal comprises placing a second leg of the staple through the modified second surface area of ​​the cuneiform.

97. 10. The method of claim 9, wherein the implant is placed in contact with each of the modified first surface area and the modified second surface area, and the implant bridges the separation between the first bone and the second bone.

98. 10. The method of claim 9, wherein modifying the surface region of at least one of the first bone and the second bone using the contour guide to form the modified surface region on one or both of the first bone and the second bone comprises positioning a bone surface modifying instrument on the contour guide and contacting the surface region of at least one of the first bone and the second bone.

99. 10. The method of claim 9, wherein the bone surface modifying tool positioned on the contour guide and in contact with the surface region of at least one of the first bone and the second bone is configured to fracture bone at the surface region of at least one of the first bone and the second bone.

100. 10. The method of claim 1, wherein the bone surface modifying tool positioned on the contour guide and brought into contact with the surface region of at least one of the first bone and the second bone comprises at least one of a burr and a saw.

101. 10. The method of claim 9, wherein the contour guide comprises a contour guide body having an upper side and a lower side, the lower side including a guide slot defining a guide slot cross-sectional area that is greater than a cross-sectional area of ​​the implant, and wherein positioning the contour guide comprises positioning the lower side of the contour guide against the first bone and the second bone and across the separation between the first bone and the second bone.

102. 10. The method of claim 9, wherein positioning the underside of the contour guide on the first bone and the second bone and across the separation between the first bone and the second bone comprises positioning the guide slot on the first bone and the second bone and across the separation between the first bone and the second bone.

103. 10. The method of claim 9, wherein the contour guide body includes a guide opening, and wherein modifying the surface region of at least one of the first bone and the second bone using the contour guide to form the modified surface region on one or both of the first bone and the second bone comprises positioning a bone surface modifying instrument at least partially in the guide opening and at least partially in the guide slot and contacting the surface region of at least one of the first bone and the second bone.

104. 10. The method of claim 9, wherein the guide opening is aligned with the guide slot, the contour guide is positioned on the first bone and the second bone and across the separation between the first bone and the second bone, and the bone surface modifying instrument is inserted first into the guide opening, then into the guide slot, and then placed in contact with the surface region of at least one of the first bone and the second bone to modify the surface region of at least one of the first bone and the second bone.

105. 10. The method of claim 9, further comprising positioning an implant guide sleeve on the first bone and the second bone and across the separation between the first bone and the second bone, wherein the contour guide is positioned on the first bone and the second bone and across the separation between the first bone and the second bone using the implant guide sleeve.

106. 10. The method of claim 9, further comprising fixing the implant guide sleeve to the first bone and the second bone before positioning the contour guide with the implant guide sleeve on the first bone and the second bone and across the separation between the first bone and the second bone.

107. 10. The method of claim 9, wherein modifying the surface area of ​​at least one of the first bone and the second bone using the contour guide to form the modified surface area on one or both of the first bone and the second bone comprises modifying the surface area using the contour guide while the contour guide is at least partially positioned within the implant guide sleeve.

108. 10. The method of claim 9, further comprising: after positioning the contour guide using the implant guide sleeve and modifying the surface area of ​​at least one of the first bone and the second bone using the contour guide to form the modified surface area in one or both of the first bone and the second bone, advancing an inserter operatively connected to the implant relative to the implant guide sleeve to position the implant in contact with at least the modified surface area.

109. 1. A method for placing an implant in one or more bone portions, the method comprising: placing a trial member in the one or more bone portions, the trial member simulating configuration of the implant in the one or more bone portions; determining the relative fit of the trial member on the one or more bone portions; after placing the trial members in the one or more bone portions, creating one or more implant-receiving openings at the one or more bone portions where the trial members were placed; and placing the implant into the one or more created implant-receiving openings.

110. 10. The method of the preceding claim, wherein the implant is a staple and the trial member simulates at least one dimension of the staple.

111. 10. The method of any one of the preceding claims, wherein the trial member includes a trial bridge defining a trial arch, the trial arch corresponding to the arch defined by the bridge of the staple.

112. 10. The method of claim 1, wherein determining the relative fit of the trial members in the one or more bone portions comprises determining the fit of the trial arch in the one or more bone portions.

113. 1. A method for placing an implant in one or more bone portions, the method comprising: inserting a pinning and drilling instrument a first distance into the one or more bone portions at a location in the one or more bone portions such that a pin portion of the pinning and drilling instrument is inserted into the one or more bone portions at the location; after inserting the pinning and drilling instrument into the one or more bone portions the first distance, further inserting the pinning and drilling instrument into the one or more bone portions a second further distance at the location in the one or more bone portions to create an implant-receiving opening at the location, and a drill portion of the pinning and drilling instrument is inserted into the one or more bone portions to create the implant-receiving opening at the location; and placing an implant in the implant-receiving opening.

114. 10. The method of claim 1, wherein the implant-receiving opening is created at the location by further inserting the pinning and drilling instrument the second further distance into the one or more bone portions while the pin portion of the pinning and drilling instrument is in the location in the one or more bone portions.

115. 10. The method of any one of the preceding claims, wherein the drill portion of the pinning and drilling instrument includes a drill flute that begins where the pin portion ends, and wherein further inserting the pinning and drilling instrument a second further distance into the one or more bone portions comprises rotationally driving the drill flute of the pin portion into the location of the one or more bone portions.

116. inserting the pin portion of the pinning and drilling instrument into the one or more bone portions at the location includes creating a tacking opening of a first diameter extending into the one or more bone portions at the location; 10. The method of claim 1, wherein creating the implant-receiving opening at the location by rotationally driving the drill flutes of the drill portion into the location of the one or more bone portions includes creating the implant-receiving opening of a second diameter extending into the one or more bones at the location, the second diameter of the implant-receiving opening being larger than the first diameter of the tacking opening.

117. 10. The method of any one of the preceding claims, wherein placing the implant in the implant receiving opening comprises placing a portion of the implant within the implant receiving opening, the portion of the implant being larger than the first diameter of the tacking opening and smaller than the second diameter of the implant receiving opening.

118. the pin portion of the pinning and drilling instrument comprises a first cross-sectional area of ​​the pinning and drilling instrument, and the drill portion of the pinning and drilling instrument comprises a second cross-sectional area of ​​the pinning and drilling instrument, the second cross-sectional area being greater than the first cross-sectional area; 10. The method of any one of the preceding claims, further comprising temporarily terminating insertion of the pin portion of the pinning and drilling instrument the first distance into the one or more bone portions of the location when the second cross-sectional area contacts the one or more bone portions of the location.

119. 10. The method of any one of the preceding claims, further comprising imaging the position of the pin portion within the one or more bone portions at the location after inserting the pinning and drilling instrument the first distance into the one or more bone portions and before creating the implant-receiving opening at the location by further inserting the pinning and drilling instrument the second further distance into the one or more bone portions.

120. 10. The method of any one of the preceding claims, wherein the one or more bone portions comprise a first bone and a second bone separated by a joint cavity, and wherein imaging the position of the pin portion comprises imaging the position of the pin portion within one of the first bone or the second bone and relative to the joint cavity.

121. 10. The method of any one of the preceding claims, wherein the first bone is a metatarsal, the second bone is a cuneiform bone, and the joint space is the tarsometatarsal joint space.

122. 10. The method of any one of the preceding claims, wherein when the imaged position of the pin portion determines that the pin portion is spaced from a joint space adjacent the one or more bones, the pinning and drilling instrument is inserted the second further distance into the one or more bone portions to create the implant-receiving opening at the location.

123. 10. The method of claim 1, wherein placing the implant in the implant receiving opening comprises placing a portion of the implant within the implant receiving opening, the portion of the implant placed within the implant receiving opening having an implant portion length equal to a length of the drill portion.

124. placing a drill guide on the one or more bone portions; 10. The method of any one of the preceding claims, further comprising inserting the pinning and drilling instrument in the drill guide and into the one or more bone portions at the location, using the pinning and drilling instrument to temporarily fix the drill guide to the one or more bone portions.

125. 10. The method of any one of the preceding claims, wherein creating the implant-receiving opening at the location by further inserting the pinning and drilling instrument a second further distance into the one or more bone portions at the location comprises further inserting the pinning and drilling instrument through the drill guide such that the drill portion extends from the drill guide.

126. the one or more bones include a first bone and a second bone; the implant is a staple including a first leg, a second leg, and a bridge bridging the first leg and the second leg; the implant receiving opening is a first implant receiving opening; the location is a first location of the first bone, and the pinning and drilling instrument is a first pinning and drilling instrument inserted into the first bone a first distance and further inserted into the first bone a second further distance to create the first implant-receiving opening in the first bone; moreover, inserting a second pinning and drilling instrument a third distance into the second bone at a second location on the second bone such that a pin portion of the second pinning and drilling instrument is inserted into the second bone at the second location; after inserting the second pinning and drilling instrument the third distance into the second bone, further inserting the second pinning and drilling instrument a fourth additional distance into the second bone at the second location to create a second implant-receiving opening at the second location, such that a drill portion of the second pinning and drilling instrument is inserted into the second bone to create the second implant-receiving opening at the second location; and 10. The method of any one of the preceding claims, comprising placing the first leg of the staple in the first implant receiving opening and the second leg of the staple in the second implant receiving opening.

127. 10. The method of any one of the preceding claims, wherein the first distance corresponds to a length of the first leg of the staple and the third distance corresponds to a length of the second leg of the staple.

128. further comprising placing a drill guide in the first bone and the second bone; 10. The method of any one of the preceding claims, wherein the first pinning and drilling instrument is inserted into the first bone in the drill guide and the second pinning and drilling instrument is inserted into the second bone in the drill guide to provisionally fix the drill guide in the first bone and the second bone.

129. 10. The method of any one of the preceding claims, wherein the drill guide includes a trial member that simulates at least one dimension of the staple, and wherein placing the drill guide in the first bone and the second bone includes placing the trial member in the first bone, in the second bone, and across a joint space separating the first bone and the second bone.

130. 10. The method of any one of the preceding claims, further comprising imaging the positions of the pin portions of the first pinning and drilling instrument within the first bone and imaging the positions of the pin portions of the second pinning and drilling instrument within the second bone after inserting the first pinning and drilling instrument the first distance into the first bone, after inserting the second pinning and drilling instrument the third distance into the second bone, after placing the drill guide and before creating the first and second implant-receiving openings.