Orthopedic implants and instruments

Abstract

The orthopaedic implant system includes an insertion tool having an actuator and a retention mechanism. The implant system includes an orthopaedic staple implant configured to releasably couple with the retention mechanism of the insertion tool and to separate from the insertion tool by actuation of the actuator. Also disclosed is a surgical tool having an upper portion and a lower portion, the lower portion being integral with the upper portion. The lower portion has a laterally extending actuator and a pair of retainers extending from the lower portion. Each retainer has a curved shape toward the midline of the tool. Also disclosed is an orthopaedic staple implant having a bridge and a pair of legs extending from a bottom surface of the bridge. Each leg has a roughened or gripping structure disposed on an inner surface of the leg.

Description

[Technical field]

[0001] [CROSS-REFERENCE TO RELATED APPLICATIONS] This application claims priority to U.S. Provisional Application No. 63 / 362,569, filed April 6, 2022, entitled "ORTHOPEDIC INTERLEAD INSTRUMENT," the entire disclosure of which is incorporated herein by reference.

[0002] [Technical field] The present invention relates to podiatric and orthopedic implants and procedures associated with joint replacement, arthroplasty, arthrodesis, and release of the foot and ankle joints and / or procedures involving the surrounding bone and soft tissue. [Background technology]

[0003] Many of the currently available implants, devices, and methods for addressing bone, soft tissue, and joint trauma (acute and chronic, e.g., defects, gradual deterioration, etc.) do not fully address the needs of patients. Furthermore, many of the currently available implants, devices, and methods for addressing joint trauma do not take into account the anatomical characteristics of the joint and its associated mechanical and kinematic movement patterns and function. Summary of the Invention

[0004] A first aspect of the present invention relates to an orthopaedic implant system comprising an insertion tool having an actuator and a retention mechanism, and an implant configured to be releasably coupled to the retention mechanism of the insertion tool and to be decoupled from the insertion tool in response to actuation of the actuator.

[0005] According to a first aspect of the invention, the insertion tool comprises an upper portion and a lower portion, the upper portion and the lower portion being integral with each other.

[0006] According to a first aspect of the invention, the actuator is integrated into the lower portion of the insertion tool.

[0007] According to a first aspect of the invention, the actuator extends laterally from the lower portion of the insertion tool.

[0008] According to a first aspect of the invention, the retention mechanism extends from the bottom portion of the insertion instrument, the retention mechanism comprising a pair of retention portions.

[0009] According to the first aspect of the present invention, the pair of holding portions are arranged on both sides (opposite sides) of the bottom of the insertion tool.

[0010] According to the first aspect of the present invention, the insertion device includes a volume portion (space portion) that is vertically defined by the lower portion of the insertion device and horizontally defined by the pair of holding portions.

[0011] According to the first aspect of the present invention, each of the holding portions has a substantially curved shape, the curved shape being a shape extending toward the volume portion (space portion).

[0012] According to a first aspect of the invention, the volume is configured to receive and hold at least a portion of the implant.

[0013] According to a first aspect of the invention, the actuation of the actuator is an actuation of at least one of the retaining parts to couple and detach the implant with respect to the insertion tool.

[0014] According to a first aspect of the invention, the implant comprises an orthopaedic staple.

[0015] A second aspect of the present invention relates to a surgical instrument comprising an upper portion and a lower portion, the lower portion being integral with the upper portion and disposed opposite the upper portion, the lower portion comprising an actuator extending laterally from the lower portion and a pair of retainers extending from a bottom of the lower portion toward the opposite side of the upper portion, each of the pair of retainers having a substantially curved shape, the curvature extending toward the midline of the instrument.

[0016] According to a second aspect of the invention, the instrument further comprises a first volume portion (first space portion) at least partially defined (defined) by a side surface of the instrument and a side surface of the actuator.

[0017] According to a second aspect of the present invention, the actuator is operable (operable) such that at least a portion of the actuator occupies at least a portion of the first volume portion (first space portion).

[0018] According to a second aspect of the invention, the actuator is pivotable relative to the lower part of the instrument.

[0019] According to the second aspect of the present invention, by operating (activating) the actuator, the lateral dimension of a second volume portion (second space portion) partitioned (defined) laterally by the pair of retaining portions changes.

[0020] A third aspect of the invention relates to an orthopaedic staple-type implant comprising a bridge and a pair of legs extending from a bottom surface of the bridge, each of the legs having a roughened surface (texture) on its inner surface.

[0021] According to a third aspect of the invention, the implant is movable between a first position in which the bridge is in a substantially curved configuration and a second position in which the bridge is in a substantially straight configuration.

[0022] According to a third aspect of the invention, each of the legs extends from a bottom surface of the bridge at a location between a midline of the bridge and an end of the bridge.

[0023] According to a third aspect of the invention, each of the legs has a tapered thickness, the thickness being greater adjacent the bridge than adjacent the distal end of the leg. [Brief description of the drawings]

[0024] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the present invention and, together with the detailed description, serve to explain the principles of the present invention. In the drawings, various features may or may not be drawn to scale, in accordance with standard practice in the industry. In fact, dimensions of various features may be arbitrarily expanded or reduced for clarity of discussion. The drawings are only for purposes of illustrating embodiments of the present invention and are not to be construed as limiting the invention.

[0025] [Figure 1] FIG. 1 is a front view of an orthopaedic implant system including an orthopaedic surgical instrument and an orthopaedic implant according to the present invention. [Diagram 2] 2 is a rear view of the orthopaedic implant system of FIG. 1 including an orthopaedic surgical instrument and an orthopaedic implant in accordance with the present invention. [Diagram 3] FIG. 2 is a front perspective view of an orthopaedic surgical instrument of the implant system of FIG. 1 according to the present invention. [Figure 4] 4 is a rear perspective view of the orthopaedic surgical instrument of FIG. 3 in the implant system of FIG. 1 according to the present invention. FIG. [Diagram 5] 4 is a bottom perspective view of the orthopaedic surgical instrument of FIG. 3 in the implant system of FIG. 1 according to the present invention. FIG. [Figure 6]4 is a first side view from the right side of the orthopaedic surgical instrument of FIG. 3 in the implant system of FIG. 1 according to the present invention. FIG. [Figure 7] 4 is a second side view from the left of the orthopaedic surgical instrument of FIG. 3 in the implant system of FIG. 1 according to the present invention. FIG. [Figure 8] 4 is a top plan view of the orthopaedic surgical instrument of FIG. 3 in the implant system of FIG. 1 according to the present invention. [Figure 9] 4 is a bottom view of the orthopaedic surgical instrument of FIG. 3 in the implant system of FIG. 1 according to the present invention; FIG. [Figure 10] 4 is a side perspective view of the orthopaedic surgical instrument of FIG. 3 in the implant system of FIG. 1 according to the present invention. [Figure 11] FIG. 1 is a front view of an orthopaedic implant system including an orthopaedic surgical instrument and an orthopaedic implant according to the present invention. [Figure 12] 12 is a rear view of the orthopaedic implant system of FIG. 11 including an orthopaedic surgical instrument and an orthopaedic implant in accordance with the present invention. [Figure 13] FIG. 1 is a front view of an orthopaedic implant system including an orthopaedic surgical instrument and an orthopaedic implant according to the present invention. [Figure 14] FIG. 14 is a rear view of the orthopaedic implant system of FIG. 13 including an orthopaedic surgical instrument and an orthopaedic implant in accordance with the present invention. [Figure 15] FIG. 1 is a front view of an orthopaedic implant system including an orthopaedic surgical instrument and an orthopaedic implant according to the present invention. [Figure 16] 16 is a rear view of the orthopaedic implant system of FIG. 15 including an orthopaedic surgical instrument and an orthopaedic implant in accordance with the present invention. [Figure 17] FIG. 1 is a front view of an orthopaedic implant system including an orthopaedic surgical instrument and an orthopaedic implant according to the present invention. [Figure 18]18 is a rear view of the orthopaedic implant system of FIG. 17 including an orthopaedic surgical instrument and an orthopaedic implant in accordance with the present invention. [Figure 19] FIG. 1 is a front view of an orthopaedic implant system including an orthopaedic surgical instrument and an orthopaedic implant according to the present invention. [Figure 20] 20 is a rear view of the orthopaedic implant system of FIG. 19 including an orthopaedic surgical instrument and an orthopaedic implant in accordance with the present invention. [Figure 21] FIG. 1 is a front view of an orthopaedic implant system including an orthopaedic surgical instrument and an orthopaedic implant according to the present invention. [Figure 22] 22 is a rear view of the orthopaedic implant system of FIG. 21 including an orthopaedic surgical instrument and an orthopaedic implant in accordance with the present invention. [Diagram 23] FIG. 1 is a front perspective view of an orthopedic implant according to the present invention. [Figure 24] FIG. 24 is a rear perspective view of the orthopedic implant of FIG. 23 according to the present invention. [Diagram 25] FIG. 24 is a side perspective view of the orthopedic implant of FIG. 23 according to the present invention. [Figure 26] FIG. 24 is a side view of the orthopedic implant of FIG. 23 in accordance with the present invention. [Figure 27] FIG. 24 is a bottom view of the orthopedic implant of FIG. 23 in accordance with the present invention. [Figure 28] FIG. 24 is a bottom perspective view of the orthopedic implant of FIG. 23 according to the present invention. [Figure 29] 24 is another perspective view of the bottom side of the orthopedic implant of FIG. 23 in accordance with the present invention. [Diagram 30] FIG. 24 is a top plan view of the orthopedic implant of FIG. 23 according to the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] In the detailed description of the invention and the appended claims herein, the terms proximal, distal, anterior, plantar, posterior, dorsal, medial, lateral, lateral, superior, and inferior are defined by standard usage to indicate a particular portion or site of a bone or implant according to the reference conditions of the relative placement or orientation of natural bone. For example, "proximal" refers to the portion of the device or implant closest to the torso and "distal" refers to the portion of the device or implant furthest from the torso. With respect to directional terms, "anterior" refers to a direction toward the front of the body, "posterior" refers to a direction toward the back of the body, "medial" refers to a direction toward the midline of the body, "lateral" refers to a direction toward the side of the body, i.e., away from the midline of the body, "superior" refers to an upward direction of another object or structure, and "inferior" refers to a downward direction of another object or structure. Furthermore, with respect to the foot specifically, the term "dorsal" refers to the top of the foot and the term "plantar" refers to the bottom of the foot.

[0027] Similarly, a location or orientation may be used herein with reference to an anatomical structure or surface. For example, the present implants, devices, instruments, and methods are described herein with reference to use on the bones of the foot, and therefore the bones of the foot, ankle, and lower leg may be used to describe the surfaces, locations, directions, or orientations of the implants, devices, instruments, and methods. Furthermore, the implants, devices, instruments, and methods disclosed herein, and their aspects, components, features, etc., are described with respect to one side of the body for purposes of brevity. However, because the human body is relatively symmetrical or mirror image about a line of symmetry (the midline), it is expressly contemplated that the implants, devices, instruments, methods, and their aspects, components, features, etc. described and / or illustrated herein may be changed, modified, reconfigured, or otherwise altered for use on or in association with the other side of the body for the same or similar purposes without departing from the spirit and scope of the present invention. For example, the implants, devices, instruments, and methods, and aspects, components, features, etc., described herein with respect to the right foot may be mirrored to function similarly in the left foot. Additionally, while the implants, devices, instruments, and methods, and aspects, components, features, etc., disclosed herein are described with respect to the foot for purposes of brevity, it will be understood that the implants, devices, instruments, and methods may also be used with other bones of the body having similar structures.

[0028] Referring to the accompanying drawings, in which like reference numbers are used to indicate like or similar components throughout the several views, and with particular reference to FIGS. 1-30, orthopedic implant systems, instruments, and implants are shown. The illustrated implant systems, instruments, and implants may be mutually compatible. For example, one or more components of the systems shown and described herein may be compatible and / or interchangeable with one or more components of alternative systems and / or instruments (implants) shown herein. Additionally, an implant (e.g., staples) may be compatible with one or more instruments (e.g., inserters), including, but not limited to, those shown and described herein. Similarly, an instrument (e.g., inserter) may be compatible with one or more implants (e.g., staples), including, but not limited to, those shown and described herein.

[0029] 1-10, an exemplary embodiment of an implant system 100 is shown. The implant system 100 may be of various sizes and may, for example, include one or more components of various sizes and complementary components of complementary sizes (e.g., may include staple implants having various heights and widths and insertion tools configured to removably couple to the staple implants).

[0030] In the illustrated example, the system 100 includes an insertion instrument 102 (hereinafter referred to as "inserter 102"). The inserter 102 is releasably coupleable to an implant 120 (e.g., a staple) (hereinafter referred to as "staple 120"). The inserter 102 and staple 120 may be provided to a physician or other healthcare provider (healthcare facility) in a coupled configuration (e.g., as shown in FIGS. 1-2) or in a separate configuration. If provided in a separate configuration, the physician or other healthcare provider may releasably couple (e.g., engage) the inserter 102 to the staple 120 prior to using or performing a procedure in which the implant system 100 and its components may be implemented. Additionally, the inserter 102 may be configured to sequentially releasably couple and detach a plurality of staples 120, and as a result, may be configured as a multi-purpose instrument. For example, a physician may releasably couple a first staple 120 to the inserter 102, then detach and embed the first staple 120, subsequently releasably couple a second staple 120 to the inserter 102, and finally detach and embed the second staple 120.

[0031] The inserter 102, in the illustrated example, includes an upper portion 104 and a lower portion 106. The upper portion 104 is disposed substantially opposite the lower portion 106. As illustrated, the staple 120 is configured to be removably coupled to a portion of the lower portion 106 of the inserter 102. That is, the upper portion 104 is disposed on the opposite side of the inserter 102 from the portion of the inserter 102 where the staple 120 is coupled. In some embodiments, one or both of the upper portion 104 and lower portion 106 of the inserter 102 may be provided with one or more ergonomic features, such as geometric contours configured to facilitate gripping and manipulation (actuation) of the inserter 102 and its components. As illustrated, the upper portion 104 and lower portion 106 are integral with one another. However, in some embodiments, the upper portion 104 and lower portion 106 may be removably, hinged, or otherwise coupled to one another.

[0032] The lower portion 106 is provided with an actuator 108 extending laterally from a side of the lower portion 106 in the illustrated example. As illustrated, the actuator 108 is integral with the lower portion 106, but is movable relative to the lower portion 106. The actuator 108 has an elongated shape extending from the lower portion 106. The actuator 108 defines a volume portion (e.g., a space, an opening, etc.) 110 located between at least a portion of the actuator 108 and the lower portion 106. The actuator 108 is operable (actuable) over a range of motion that includes at least the position (non-actuated position) shown in FIGS. 1-2 and a position (actuated position) in which at least a portion of the actuator 108 occupies at least a portion of the volume portion 110. The actuator 108 may be formed from a resilient material and / or may be structured such that a force must be applied to operate (actuate) the actuator 108 from the non-actuated position to the actuated position. Further, a force may be required to hold the actuator 108 in the actuated position, and in the absence of such force, the actuator 108 may be configured to return to the unactuated position.

[0033] The actuator 108 is operable to pivot about a pivot point 112 (or "hinge point" in some embodiments). The pivot point 112 is located at or adjacent to a location on the lower portion 106 from which the actuator 108 extends laterally. In some embodiments, the pivot point 112 may be located at a portion of the lower portion 106 that is narrower (e.g., in a lateral dimension) than the actuator 108. The pivot point 112 is located substantially below the volume 110 and above another volume (e.g., space, opening, etc.) 114. The volume 114 is configured to receive at least a portion of the actuator 108 as it moves through the aforementioned range of motion. Both volumes 110, 114 are configured to fit within the footprint of the inserter 102.

[0034] In the illustrated example, the lower portion 106 further includes a volume portion (e.g., a space, an opening, etc.) 116. The volume portion 116 is defined (partitioned) in the upper direction by the lower portion 106 and in the lateral direction by a pair of retainers (retainers) 118. In the illustrated example, each retainer 118 is provided to extend downward from the bottom of the lower portion 106 and has a substantially curved shape, i.e., a "hook-like" shape. The curve of the retainer 118 is such that it extends toward the midline of the inserter 102 (e.g., toward the volume portion 116). The illustrated volume portion 116 does not have a lower boundary (e.g., opposite the portion defined by the bottom of the lower portion 106 when the inserter 102 is in an unbound state with respect to the staple 120 (see FIG. 3 )). As shown, the volume 116 has an elongated shape (defined by three sides) with a width dimension that is greater than its height dimension.

[0035] As shown in FIGS. 1-2, when the staple 120 is in a mated configuration with the inserter 102, the volume 116 is configured to receive the bridge 122 of the staple 120. In some embodiments, the staple 120 may be manipulated from a first position (e.g., a position in which the bridge 122 is in a substantially curved shape) to a second position (e.g., a position in which the bridge 122 is in a substantially straight shape) prior to mating with the inserter 102. In some embodiments, a force may be required to manipulate the staple 120 and its bridge 122 from the first position to the second position. As shown in FIGS. 1-2, mating of the staple 120 to the inserter 102 includes at least partially disposing the bridge 122 of the staple 120 (in a substantially straight shape) within the volume 116 of the inserter 102.

[0036] The staple 120 has a pair of legs 124 extending from the bridge 122 at a substantially perpendicular angle relative to a bottom surface of the bridge 122 in the illustrated example. In the first position, the pair of legs 124 may be disposed at a substantially oblique angle relative to one another. However, in the second position (e.g., a position in which the staple 120 is held coupled to the inserter 102), the pair of legs 124 may be substantially parallel to one another. The legs 124 have a roughened surface (texture) 126 disposed on an inner surface thereof in the illustrated example. As shown in FIGS. 1-2, the roughened surface 126 has a sawtooth (tooth) configuration, although in some embodiments, the roughened surface 126 may have alternative shapes or configurations.

[0037] As shown in FIGS. 1-2, the legs 124 extend downwardly from the bottom surface of the bridge 122 adjacent the ends of the bridge 122. However, each end of the bridge 122 is configured to extend laterally beyond the point from which the legs 124 extend. The aforementioned ends (e.g., protrusions, overhangs, shoulders, etc.) of the bridge 122 are configured to engage the retaining portions 118 of the inserter 102 when the staple 120 is in the binding position shown in FIGS. 1-2. During binding of the staple 120 to the inserter 102, the staple 120 may be manipulated (actuated) to a second position (where the bridge 122 is generally straight) such that a portion of the bridge 122 is inserted into the volume portion 116. This causes the ends of the bridge 122 to abut against the retaining portions 118 such that the retaining portions 118 exert a force on the ends of the bridge 122 to hold the bridge 122 in the generally straight position.

[0038] During insertion, the actuator 108 of the inserter 102 may be manipulated (actuated) such that at least a portion of the actuator 108 occupies at least a portion of the volume 110, and in response, the retainer 118 integral with the actuator 108 disengages from the end of the bridge 122 with which the retainer 118 was engaged. The inserter 102 may be manipulated (actuated) (e.g., twisted, pivoted, hinged, etc.) to release the staple 120 from the volume 116 (releasing the end of the bridge 122 from the retainer 118 opposite the actuator 108 (second)), thereby allowing the staple 120 to return to the first position (with the pair of legs 124 forming an oblique angle with respect to one another and the bridge 122 assuming a substantially curved shape). In the second position, the staple 120 may exert a compressive force via at least one of the bridge 122 and the legs 124.

[0039] 11-12, an implant system 200 is shown according to an exemplary embodiment. The implant system 200 may be of various sizes, e.g., may include one or more components of various sizes and complementary components of complementary sizes (e.g., may include staple implants having various heights and widths and insertion tools configured to removably couple to the staple implants). Additionally, the implant system 200 may be compatible with one or more other implant systems (e.g., implant system 100) and components thereof shown and described herein.

[0040] The implant system 200, in the illustrated example, includes an insertion tool 202 (hereinafter referred to as "inserter 202"). The inserter 202 is releasably coupleable to an implant 220 (e.g., a staple) (hereinafter referred to as "staple 220"). In some embodiments, the staple 220 may be the same as or similar to the staple 120 described above. The inserter 202 and the staple 220 may be provided to a physician or other healthcare provider (healthcare facility) in a coupled form (e.g., as shown in FIGS. 11-12) or in a separated form. If provided in a separated form, the physician or other healthcare provider may releasably couple (e.g., engage) the inserter 202 to the staple 220 prior to using or performing a procedure in which the implant system 200 and its components may be implemented. Additionally, the inserter 202 may be configured to sequentially releasably couple and detach a plurality of staples 220, and as a result, may be configured as a multi-purpose tool. For example, a physician may releasably couple a first staple 220 to the inserter, then detach and embed the first staple 220, subsequently releasably couple a second staple 220 to the inserter 202, and finally detach and embed the second staple 220.

[0041] The inserter 202, in the illustrated example, comprises an upper portion 204 and a lower portion 206. The upper portion 204 is disposed substantially opposite the lower portion 206. As illustrated, the staple 220 is configured to be removably coupled to a portion of the lower portion 206 of the inserter 202. That is, the upper portion 204 is disposed on the opposite side of the inserter 202 from the portion of the inserter 202 where the staple 220 is coupled. In some embodiments, one or both of the upper portion 204 and the lower portion 206 of the inserter 202 may be provided with one or more ergonomic features (e.g., geometric contours configured to facilitate gripping and manipulation (actuation) of the inserter 202 and its components). As illustrated, the upper portion 204 and the lower portion 206 are integral with one another. The inserter 202, in the illustrated example, comprises a first portion 207 and a second portion 208. As shown in FIGS. 11-12, the first portion 207 and the second portion 208 are pivotally coupled to each other about a pivot point 212. The first portion 207 and the second portion 208 are separated from each other by a volume 210 disposed therebetween (at the top 204 of the inserter 202). The volume 210 is configured to be occupied by at least a portion of the first portion 207 and / or the second portion 208 when the first portion 207 and the second portion 208 are actuated relative to each other. In some embodiments, the first portion 207 may be configured as an actuator (similar to the actuator 108 described above) that can be actuated to facilitate engagement and disengagement of the staple 220. In some embodiments, a force may be required to actuate the first portion 207 through a range of motion.

[0042] The lower portion 206 includes a volume portion 216 in the illustrated example. The volume portion 216 is defined in the upper direction by the lower portion 206 (and the bottom of both the first portion 207 and the second portion 208) and in the lateral direction by a pair of retaining portions 218. In the illustrated example, each retaining portion 218 extends downward from the bottom of the lower portion 206 and has a substantially curved, i.e., "hook-like" shape. The retaining portions 218 are curved in such a way that they extend in the direction of the midline of the inserter 202 (e.g., toward the volume portion 216). The illustrated volume portion 216 does not have a lower boundary (e.g., opposite the portion defined by the bottom of the lower portion 206 when the inserter 202 is in an unbound state with respect to the staple 220). As illustrated, the volume portion 216 has an elongated shape (defined by three sides) with a width dimension greater than its height dimension. As shown, the coupling includes at least partially disposing the bridges 222 of the staples 220 (in the generally straight configuration described above) within the volume 216 of the inserter 202.

[0043] The staple 220, in the illustrated example, has a pair of legs 224 extending from the bridge 222 at an angle that is substantially perpendicular to the bottom surface of the bridge 222. In the first position described above, the pair of legs 224 may be disposed at a substantially oblique angle relative to one another. However, in the second position (e.g., a position in which the staple 220 is held coupled to the inserter 202), the pair of legs 224 may be substantially parallel to one another. The legs 224, in the illustrated example, have a roughened surface (texture) 226 disposed on an inner surface thereof. As shown in FIGS. 11-12, the roughened surface 226 has a sawtooth (tooth) configuration, although in some embodiments, the roughened surface 226 may have alternative shapes and / or configurations.

[0044] The legs 224 extend downwardly from the bottom surface of the bridge 222 adjacent the ends of the bridge 222, except that each end of the bridge 222 is configured to extend laterally beyond the point from which the legs 224 extend. The aforementioned ends (e.g., protrusions, overhangs, shoulders, etc.) of the bridge 222 are configured to engage the retainers 218 of the inserter 202 when in the binding position. During binding of the staple 220 to the inserter 202, the staple 220 may be manipulated (actuated) to a second position (where the bridge 222 is generally straight) such that a portion of the bridge 222 is inserted into the volume 216. This causes the ends of the bridge 222 to abut against the retainers 218 such that the retainers 218 exert a force on the ends of the bridge 222 to hold the bridge 222 in the generally straight position.

[0045] During insertion, the first portion 207 of the inserter 202 may be manipulated (actuated) such that at least a portion of the first portion 207 occupies at least a portion of the volume 210, and in response, the retainer 218 integral with the first portion 207 disengages from the end of the bridge 222 with which it was engaged. The inserter 202 may be manipulated (actuated) (e.g., twisted, pivoted, hinged, etc.) to release the staple 220 from the volume 216 (releasing the end of the bridge 222 from the opposite (second) retainer 218 from the first portion 207), thereby allowing the staple 220 to return to the first position (wherein the pair of legs 224 form an oblique angle with respect to one another and the bridge 222 assumes a substantially curved shape). In the second position, the staple 220 may exert a compressive force via at least one of the bridge 222 and the legs 224.

[0046] 13-14, an implant system 300 is shown according to an exemplary embodiment. The implant system 300 may be of various sizes, e.g., may include one or more components of various sizes and complementary components of complementary sizes (e.g., may include staple implants having various heights and widths and insertion tools configured to removably couple to the staple implants). Additionally, the implant system 300 may be compatible with one or more other implant systems (e.g., implant systems 100, 200) and components thereof shown and described herein.

[0047] The implant system 300, in the illustrated example, includes an insertion tool 302 (hereinafter referred to as "inserter 302"). The inserter 302 is releasably coupleable to an implant 320 (e.g., a staple) (hereinafter referred to as "staple 320"). In some embodiments, the staple 320 may be the same as or similar to the staples 120, 220 described above. The inserter 302 and staple 320 may be provided to a physician or other healthcare provider (healthcare facility) in a coupled configuration (e.g., as shown in FIGS. 13-14) or in a separated configuration. If provided in a separated configuration, the physician or other healthcare provider may releasably couple (e.g., engage) the inserter 302 to the staple 320 prior to using or performing a procedure in which the implant system 300 and its components may be implemented. Additionally, the inserter 302 may be configured to sequentially releasably couple and detach a plurality of staples 320, and as a result, may be configured as a multi-purpose instrument. For example, a physician may releasably couple a first staple 320 to the inserter 302, then detach and embed the first staple 320, subsequently releasably couple a second staple 320 to the inserter 302, and finally detach and embed the second staple 320.

[0048] The inserter 302, in the illustrated example, comprises an upper portion 304 and a lower portion 306. The upper portion 304 is disposed substantially opposite the lower portion 306. As illustrated, the staple 320 is configured to be removably coupled to a portion of the lower portion 306 of the inserter 302. That is, the upper portion 304 is disposed on the opposite side of the inserter 302 from the portion of the inserter 302 where the staple 320 is coupled. In some embodiments, one or both of the upper portion 304 and the lower portion 306 of the inserter 302 may be provided with one or more ergonomic features (e.g., geometric contours configured to facilitate gripping and manipulation (actuation) of the inserter 302 and its components). As illustrated, the upper portion 304 and the lower portion 306 are integral with one another. The inserter 302, in the illustrated example, comprises a first portion 307 and a second portion 308. As shown in FIGS. 13-14, the first portion 307 and the second portion 308 are pivotally coupled to each other about a pivot point 312. The first portion 307 and the second portion 308 are separated from each other by a volume 310 disposed therebetween (at the top 304 of the inserter 302). The volume 310 is configured to be occupied by at least a portion of the first portion 307 and / or the second portion 308 when the first portion 307 and the second portion 308 are actuated relative to each other. In some embodiments, the first portion 307 may be configured as an actuator (similar to the actuator 108 described above) that can be actuated to facilitate engagement and disengagement of the staple 320. In some embodiments, a force may be required to actuate the first portion 307 through a range of motion.

[0049] The lower portion 306 includes a volume portion 316 in the illustrated example. The volume portion 316 is defined in the upper direction by the lower portion 306 (and the bottom of both the first portion 307 and the second portion 308) and in the lateral direction by a pair of retaining portions 318. In the illustrated example, each retaining portion 318 extends downward from the bottom of the lower portion 306 and has a substantially curved, i.e., "hook-like" shape. The retaining portions 318 are curved in such a way that they extend in the direction of the midline of the inserter 302 (e.g., toward the volume portion 316). The illustrated volume portion 316 does not have a lower boundary (e.g., opposite the portion defined by the bottom of the lower portion 306 when the inserter 302 is in an unbound state with respect to the staple 320). As illustrated, the volume portion 316 has an elongated shape (defined by three sides) with a width dimension greater than its height dimension. As shown, the coupling includes at least partially disposing the bridges 322 of the staples 320 (in the generally straight configuration described above) within the volume 316 of the inserter 302.

[0050] The staple 320, in the illustrated example, has a pair of legs 324 extending from the bridge 322 at an angle that is substantially perpendicular to the bottom surface of the bridge 322. In the first position described above, the pair of legs 324 may be disposed at a substantially oblique angle relative to one another. However, in the second position (e.g., a position in which the staple 320 is held coupled to the inserter 302), the pair of legs 324 may be substantially parallel to one another. The legs 324, in the illustrated example, have a texture 326 disposed on an inner surface thereof. As shown in FIGS. 13-14, the texture 326 has a sawtooth (tooth) configuration, although in some embodiments, the texture 326 may have alternative shapes and / or configurations.

[0051] The legs 324 extend downwardly from the bottom surface of the bridge 322 adjacent the ends of the bridge 322, but each end of the bridge 322 is configured to extend laterally beyond the point from which the legs 324 extend. The aforementioned ends (e.g., protrusions, overhangs, shoulders, etc.) of the bridge 322 are configured to engage the retainers 318 of the inserter 302 when in the binding position. Upon binding of the staple 320 to the inserter 302, the staple 320 may be manipulated (actuated) to a second position (where the bridge 322 is generally straight) such that a portion of the bridge 322 is inserted into the volume 316. This causes the ends of the bridge 322 to abut against the retainers 318 such that the retainers 318 exert a force on the ends of the bridge 322 to hold the bridge 322 in the generally straight position.

[0052] During insertion, the first and / or second portions 307, 308 of the inserter 302 may be manipulated (actuated) such that at least a portion of the first and / or second portions 307, 308 occupy at least a portion of the volume 310, and in response, the retainer 318 integral with the first portion 307 disengages from the end of the bridge 322 with which it was engaged. The inserter 302 may be manipulated (actuated) (e.g., twisted, pivoted, hinged, etc.) to release the staple 320 from the volume 316 (releasing the end of the bridge 322 from the opposite (second) retainer 318 from the first portion 307), thereby allowing the staple 320 to return to the first position (with the pair of legs 324 forming an oblique angle with respect to one another and the bridge 322 assuming a substantially curved shape). In the second position, the staple 320 can apply a compressive force via at least one of the bridge 322 and the legs 324 .

[0053] 15-16, an implant system 400 is shown according to an exemplary embodiment. The implant system 400 may be of various sizes, e.g., may include one or more components of various sizes and complementary components of complementary sizes (e.g., may include staple implants having various heights and widths and insertion tools configured to removably couple to the staple implants). Additionally, the implant system 400 may be compatible with one or more other implant systems (e.g., implant systems 100, 200) and components thereof shown and described herein.

[0054] The implant system 400, in the illustrated example, includes an insertion tool 402 (hereinafter referred to as "inserter 402"). The inserter 402 is releasably coupleable to an implant 420 (e.g., a staple) (hereinafter referred to as "staple 420"). In some embodiments, the staple 420 may be the same as or similar to the staples 120, 220 described above. The inserter 402 and staple 420 may be provided to a physician or other healthcare provider (healthcare facility) in a coupled configuration (e.g., as shown in FIGS. 15-16) or in a separated configuration. If provided in a separated configuration, the physician or other healthcare provider may releasably couple (e.g., engage) the inserter 402 to the staple 420 prior to using or performing a procedure in which the implant system 400 and its components may be implemented. Additionally, the inserter 402 may be configured to sequentially releasably couple and detach a plurality of staples 420, and as a result, may be configured as a multi-purpose instrument. For example, a physician may releasably couple a first staple 420 to the inserter 402, then detach and embed the first staple 420, subsequently detachably couple a second staple 420 to the inserter 402, and finally detach and embed the second staple 420.

[0055] The inserter 402, in the illustrated example, comprises an upper portion 404 and a lower portion 406. The upper portion 404 is disposed substantially opposite the lower portion 406. As illustrated, the staple 420 is configured to be removably coupled to a portion of the lower portion 406 of the inserter 402. That is, the upper portion 404 is disposed on the opposite side of the inserter 402 from the portion of the inserter 402 to which the staple 420 is coupled. In some embodiments, one or both of the upper portion 404 and the lower portion 406 of the inserter 402 may be provided with one or more ergonomic features (e.g., geometric contours configured to facilitate gripping and manipulation (actuation) of the inserter 402 and its components). As illustrated, the upper portion 404 and the lower portion 406 are integral with one another. The inserter 402, in the illustrated example, comprises a first portion 407 and a second portion 408. As shown in FIGS. 15-16, the first portion 407 and the second portion 408 are pivotally coupled to each other about a pivot point 412. The first portion 407 and the second portion 408 are separated from each other by a volume 410 disposed therebetween (at the top 404 of the inserter 402). The volume 410 is configured to be occupied by at least a portion of the first portion 407 and / or the second portion 408 when the first portion 407 and the second portion 408 are actuated relative to each other. In some embodiments, the first portion 407 may be configured as an actuator (similar to the actuator 108 described above) that can be actuated to facilitate engagement and disengagement with the staple 420. In some embodiments, a force may be required to actuate the first portion 407 through a range of motion.

[0056] The lower portion 406 includes a volume portion 416 in the illustrated example. The volume portion 416 is defined (bounded) in the upper direction by the lower portion 406 (and the bottom of both the first portion 407 and the second portion 408) and in the lateral direction by a pair of retaining portions 418. In the illustrated example, each retaining portion 418 is provided to extend downward from the bottom of the lower portion 406 and has a substantially curved shape, i.e., a "hook-like" shape. The retaining portions 418 are curved in such a way that they extend in the direction of the midline of the inserter 402 (e.g., toward the volume portion 416). The illustrated volume portion 416 does not have a lower boundary (e.g., opposite the portion defined by the bottom of the lower portion 406 when the inserter 402 is in an unbound state with respect to the staple 420). As illustrated, the volume portion 416 has an elongated shape (defined by three sides) with a width dimension greater than its height dimension. As shown, the coupling includes at least partially disposing the bridges 422 of the staples 420 (in the generally straight configuration described above) within the volume 416 of the inserter 402 .

[0057] The staple 420 has a pair of legs 424 extending from the bridge 422 at a substantially perpendicular angle relative to a bottom surface of the bridge 422 in the illustrated example. In the first position, the pair of legs 424 may be disposed at a substantially oblique angle relative to one another. However, in the second position (e.g., a position in which the staple 420 is held coupled to the inserter 402), the pair of legs 424 may be substantially parallel to one another. The legs 424 have a roughened surface (texture) 426 disposed on an inner surface thereof in the illustrated example. As shown in FIGS. 15-16, the roughened surface 426 has a sawtooth (tooth) configuration, although in some embodiments, the roughened surface 426 may have alternative shapes and / or configurations.

[0058] The legs 424 extend downwardly from the bottom surface of the bridge 422 adjacent the ends of the bridge 422, except that each end of the bridge 422 is configured to extend laterally beyond the point from which the legs 424 extend. The aforementioned ends (e.g., protrusions, overhangs, shoulders, etc.) of the bridge 422 are configured to engage the retainers 418 of the inserter 402 when in the binding position. Upon binding of the staple 420 to the inserter 402, the staple 420 may be manipulated (actuated) to a second position (where the bridge 422 is generally straight) such that a portion of the bridge 422 is inserted into the volume 416. This causes the ends of the bridge 422 to abut against the retainers 418 such that the retainers 418 exert a force on the ends of the bridge 422 to hold the bridge 422 in the generally straight position.

[0059] During insertion, the first and / or second portions 407, 408 of the inserter 402 may be manipulated (actuated) such that at least a portion of the first and / or second portions 407, 408 occupy at least a portion of the volume 410, and in response, the retainer 418 integral with the first portion 407 disengages from the end of the bridge 422 with which it was engaged. The inserter 402 may be manipulated (actuated) (e.g., twisted, pivoted, hinged, etc.) to release the staple 420 from the volume 416 (releasing the end of the bridge 422 from the opposite (second) retainer 418 from the first portion 407), thereby allowing the staple 420 to return to the first position (with the pair of legs 424 forming an oblique angle with respect to one another and the bridge 422 assuming a substantially curved shape). In the second position, the staple 420 can apply a compressive force via the bridge 422 and at least one of the legs 424 .

[0060] 17-18, an implant system 500 is shown in accordance with an exemplary embodiment. The implant system 500 may be of various sizes and may, for example, include one or more components of various sizes and complementary components of complementary sizes (e.g., may include staple implants having various heights and widths and insertion tools configured to removably couple to the staple implants).

[0061] In the illustrated example, the implant system 500 includes an insertion tool 502 (hereinafter referred to as "inserter 502"). The inserter 502 is releasably connectable to an implant 520 (e.g., a staple) (hereinafter referred to as "staple 520"). The inserter 502 and the staple 520 may be provided to a physician or other healthcare provider (healthcare facility) in a connected form (e.g., as shown in FIGS. 17-18) or in a separated form. If provided in a separated form, the physician or other healthcare provider may releasably connect (e.g., engage) the inserter 502 to the staple 520 prior to using or performing a procedure in which the implant system 500 and its components may be implemented. Additionally, the inserter 502 may be configured to releasably connect and disconnect multiple staples 520 in succession, and as a result, may be configured as a multi-purpose tool. For example, a physician may releasably couple a first staple 520 to the inserter 502, then detach and implant the first staple 520, subsequently detachably couple a second staple 520 to the inserter 502, and finally detach and implant the second staple 520. Both the inserter 502 and the staples 520 may be similarly configured and / or compatible with the implant systems and components described herein above.

[0062] The inserter 502, in the illustrated example, includes an upper portion 504 and a lower portion 506. The upper portion 504 is disposed substantially opposite the lower portion 506. As illustrated, the staple 520 is configured to be removably coupled to a portion of the lower portion 506 of the inserter 502. That is, the upper portion 504 is disposed on the opposite side of the inserter 502 from the portion of the inserter 502 to which the staple 520 is coupled. In some embodiments, one or both of the upper portion 504 and the lower portion 506 of the inserter 502 may be provided with one or more ergonomic features, such as a geometric contour configured to facilitate gripping and manipulation (actuation) of the inserter 502 and its components. As illustrated, the upper portion 504 and the lower portion 506 are integral with one another. However, in some embodiments, the upper portion 504 and the lower portion 506 may be removably, hinged, or otherwise coupled to one another.

[0063] The lower portion 506 is provided with an actuator 508 that extends laterally from a side of the lower portion 506 in the illustrated example. As illustrated, the actuator 508 is integral with the lower portion 506, but is movable relative to the lower portion 506. The actuator 508 has an elongated shape extending from the lower portion 506. The actuator 508 defines a volume portion (e.g., a space, an opening, etc.) 510 located between at least a portion of the actuator 508 and the lower portion 506. The actuator 508 is operable (actuable) over a range of motion that includes at least the position (non-actuated position) shown in Figures 17-18 and a position (actuated position) in which at least a portion of the actuator 508 occupies at least a portion of the volume portion 510. The actuator 508 may be formed from a resilient material and / or may be structured such that a force must be applied to operate (actuate) the actuator 508 from the non-actuated position to the actuated position. Further, a force may be required to hold the actuator 508 in the actuated position, and in the absence of such force, the actuator 508 may be configured to return to the unactuated position.

[0064] The actuator 508 is operable to pivot about a pivot point 512 ("hinge point" in some embodiments). The pivot point 512 is located at or adjacent to a location on the lower portion 506 from which the actuator 508 extends laterally. In some embodiments, the pivot point 512 may be located at a portion of the lower portion 506 that is narrower in width (e.g., lateral dimension) than the actuator 508. Furthermore, the pivot point 512 is located substantially below the volume 510 and above another volume (e.g., space, opening, etc.) 514. The volume 514 is configured to receive at least a portion of the actuator 508 as the actuator 508 moves through the aforementioned range of motion.

[0065] The lower portion 506 further includes a volume portion (e.g., a space, an opening, etc.) 516 in the illustrated example. The volume portion 516 is defined (defined) in the upper direction by the lower portion 506 and in the lateral direction by a pair of retainers (retainers) 518. In the illustrated example, each retainer 518 is provided to extend downward from a bottom of the lower portion 506 and has a substantially curved, i.e., "hook-like" shape. The curve of the retainer 518 is such that it extends toward the midline of the inserter 502 (e.g., toward the volume portion 516). The illustrated volume portion 516 does not have a lower boundary (e.g., opposite the portion defined by the bottom of the lower portion 506 when the inserter 502 is in an unbound state with respect to the staple 520). As illustrated, the volume portion 516 has an elongated shape (defined by three sides) with a width dimension greater than its height dimension.

[0066] As shown in FIGS. 17-18, the volume 516 is configured to receive the bridge 522 of the staple 520 when the staple 520 is in a mated configuration with the inserter 502. In some embodiments, the staple 520 may be manipulated (actuated) from a first position (e.g., a position where the bridge 522 is in a substantially curved shape) to a second position (e.g., a position where the bridge 522 is in a substantially straight shape) prior to mating with the inserter 502. In some embodiments, a force may be required to manipulate the staple 520 and its bridge 522 from the first position to the second position. As shown, the mating includes at least partially disposing the bridge 522 of the staple 520 (in the aforementioned substantially straight shape) within the volume 516 of the inserter 502.

[0067] The staple 520 has a pair of legs 524 extending from the bridge 522 at a substantially perpendicular angle relative to a bottom surface of the bridge 522 in the illustrated example. In the first position, the pair of legs 524 may be disposed at a substantially oblique angle relative to one another. However, in the second position (e.g., a position in which the staple 520 is held coupled to the inserter 502), the pair of legs 524 may be substantially parallel to one another. The legs 524 have a roughened surface (texture) 526 disposed on an inner surface thereof in the illustrated example. As shown in FIGS. 17-18, the roughened surface 526 has a sawtooth (tooth) configuration, although in some embodiments, the roughened surface 526 may have alternative shapes and configurations.

[0068] The legs 524 extend downwardly from the bottom surface of the bridge 522 adjacent the ends of the bridge 522. However, each end of the bridge 522 is configured to extend laterally beyond the point from which the legs 524 extend. The aforementioned ends (e.g., protrusions, overhangs, shoulders, etc.) of the bridge 522 are configured to engage the retaining portion 518 of the inserter 502 when the staple 520 is in the binding position shown in Figures 17-18. During binding of the staple 520 to the inserter 502, the staple 520 may be manipulated (actuated) to a second position (where the bridge 522 is generally straight) such that a portion of the bridge 522 is inserted into the volume portion 516. This causes the ends of the bridge 522 to abut against the retaining portion 518 such that the retaining portion 518 exerts a force on the ends of the bridge 522 to hold the bridge 522 in the generally straight position.

[0069] During insertion, the actuator 508 of the inserter 502 may be manipulated (actuated) such that at least a portion of the actuator 508 occupies at least a portion of the volume 510, and in response, the retainer 518 integral with the actuator 508 disengages from the end of the bridge 522 with which the retainer 518 was engaged. The inserter 502 may be manipulated (actuated) (e.g., twisted, pivoted, hinged, etc.) to release the staple 520 from the volume 516 (releasing the end of the bridge 522 from the retainer 518 on the opposite (second) side from the actuator 508), thereby allowing the staple 520 to return to the first position (with the pair of legs 524 forming an oblique angle with respect to one another and the bridge 522 assuming a substantially curved shape). In the second position, the staple 520 may exert a compressive force via at least one of the bridge 522 and the legs 524.

[0070] 19-20, an implant system 600 is shown in accordance with one exemplary embodiment. The implant system 600 may be of various sizes and may, for example, include one or more components of various sizes and complementary components of complementary sizes (e.g., may include staple implants having various heights and widths and insertion tools configured to removably couple to the staple implants).

[0071] In the illustrated example, the implant system 600 includes an insertion tool 602 (hereinafter referred to as "inserter 602"). The inserter 602 is releasably connectable to an implant 620 (e.g., a staple) (hereinafter referred to as "staple 620"). The inserter 602 and staple 620 may be provided to a physician or other healthcare provider (healthcare facility) in a connected configuration (e.g., as shown in Figures 19-20) or in a separate configuration. If provided in a separate configuration, the physician or other healthcare provider may releasably connect (e.g., engage) the inserter 602 to the staple 620 prior to using or performing a procedure in which the implant system 600 and its components may be implemented. Additionally, the inserter 602 may be configured to releasably connect and disconnect multiple staples 620 in succession, and as a result, may be configured as a multi-purpose tool. For example, a physician may releasably couple a first staple 620 to the inserter 602, then detach and implant the first staple 620, subsequently detachably couple a second staple 620 to the inserter 602, and finally detach and implant the second staple 620. Both the inserter 602 and the staples 620 may be similarly configured and / or compatible with the implant systems and components described herein above.

[0072] The inserter 602, in the illustrated example, includes an upper portion 604 and a lower portion 606. The upper portion 604 is disposed substantially opposite the lower portion 606. As illustrated, the staple 620 is configured to releasably couple to a portion of the lower portion 606 of the inserter 602. That is, the upper portion 604 is disposed on the opposite side of the inserter 602 from the portion of the inserter 602 where the staple 620 is coupled. In some embodiments, one or both of the upper portion 604 and the lower portion 606 of the inserter 602 may be provided with one or more ergonomic features, such as a geometric contour configured to facilitate gripping and manipulation (actuation) of the inserter 602 and its components. As illustrated, the upper portion 604 and the lower portion 606 are integral with one another. However, in some embodiments, the upper portion 604 and the lower portion 606 may be releasably, hingedly, or otherwise coupled to one another.

[0073] In the illustrated example, the lower portion 606 is provided with a pair of actuators 608 extending laterally from both sides of the lower portion 606. As illustrated, the actuators 608 are integral with the lower portion 606, but are movable relative to the lower portion 606. The actuators 608 have an elongated shape extending from the lower portion 606. The actuators 608 define a volume portion (e.g., a space, an opening, etc.) 610 located between at least a portion of the actuators 608 and the lower portion 606. The actuators 608 are operable (actuable) over a range of motion that includes at least the position (non-actuated position) shown in FIGS. 19-20 and a position (actuated position) in which at least a portion of the actuators 608 occupies at least a portion of the volume portion 610. The actuators 608 may be formed from a resilient material and / or may be structured such that a force must be applied to operate the actuators 608 from the non-actuated position to the actuated position. Further, a force may be required to hold the actuator 608 in the actuated position, and in the absence of such force, the actuator 608 may be configured to return to the unactuated position.

[0074] The pair of actuators 608 are operable to pivot about a pair of pivot points 612 ("hinge points" in some embodiments). The pivot points 612 are located at or adjacent to the locations on the lower portion 606 from which the actuators 608 extend laterally. In some embodiments, the pivot points 612 may be located at a portion of the lower portion 606 that is narrower in width (e.g., lateral dimension) than the actuators 608. Additionally, the pivot points 612 are located substantially below the volume 610 and above another pair of volumes (e.g., spaces, openings, etc.) 614 that are configured to receive at least a portion of the actuators 608 as they move through the aforementioned range of motion.

[0075] The lower portion 606 further includes a volume portion (e.g., a space, an opening, etc.) 616 in the illustrated example. The volume portion 616 is defined in the upper direction by the lower portion 606 and in the lateral direction by a pair of retainers 618. In the illustrated example, each retainer 618 extends downward from a bottom of the lower portion 606 and has a substantially curved or "hook-like" shape. The retainers 618 are curved toward the midline of the inserter 602 (e.g., toward the volume portion 616). The illustrated volume portion 616 does not have a lower boundary (e.g., opposite the portion defined by the bottom of the lower portion 606 when the inserter 602 is in an unbounded state with respect to the staple 620). As illustrated, the volume portion 616 has an elongated shape (defined by three sides) with a width dimension greater than its height dimension.

[0076] As shown in FIGS. 19-20 , the volume 616 is configured to receive the bridge 622 of the staple 620 when the staple 620 is in a mated configuration with the inserter 602. In some embodiments, the staple 620 may be manipulated (actuated) from a first position (e.g., a position where the bridge 622 is in a substantially curved shape) to a second position (e.g., a position where the bridge 622 is in a substantially straight shape) prior to mating with the inserter 602. In some embodiments, a force may be required to manipulate the staple 620 and its bridge 622 from the first position to the second position. As shown, the mating includes at least partially disposing the bridge 622 of the staple 620 (in the aforementioned substantially straight shape) within the volume 616 of the inserter 602.

[0077] The staple 620 has a pair of legs 624 extending from the bridge 622 at a substantially perpendicular angle relative to a bottom surface of the bridge 622 in the illustrated example. In the first position, the pair of legs 624 may be disposed at a substantially oblique angle relative to one another. However, in the second position (e.g., a position in which the staple 620 is held coupled to the inserter 602), the pair of legs 624 may be substantially parallel to one another. The legs 624 have a roughened surface (texture) 626 disposed on an inner surface thereof in the illustrated example. As shown in FIGS. 19-20, the roughened surface 626 has a sawtooth (tooth) configuration, although in some embodiments, the roughened surface 626 may have alternative shapes and configurations.

[0078] The legs 624 extend downwardly from the bottom surface of the bridge 622 adjacent the ends of the bridge 622. However, each end of the bridge 622 is configured to extend laterally beyond the point from which the legs 624 extend. The aforementioned ends (e.g., protrusions, overhangs, shoulders, etc.) of the bridge 622 are configured to engage the retaining portion 618 of the inserter 602 when the staple 620 is in the coupled position shown in Figures 19-20. During coupling of the staple 620 to the inserter 602, the staple 620 may be manipulated (actuated) to a second position (where the bridge 622 is generally straight) such that a portion of the bridge 622 is inserted into the volume portion 616. This causes the ends of the bridge 622 to abut against the retaining portion 618 such that the retaining portion 618 exerts a force on the ends of the bridge 622 to hold the bridge 622 in the generally straight position.

[0079] During insertion, one or both actuators 608 of the inserter 602 may be manipulated (actuated) such that at least a portion of the actuator 608 occupies at least a portion of the volume 610, and in response, the retainer 618 integral with the actuator 608 disengages from the end of the bridge 622 with which the retainer 618 engaged. The inserter 602 may be manipulated (actuated) (e.g., twisted, pivoted, hinged, etc.) to release the staple 620 from the volume 616, thereby allowing the staple 620 to return to the first position (with the pair of legs 624 forming an oblique angle with respect to one another and the bridge 622 assuming a substantially curved shape). In the second position, the staple 620 may exert a compressive force via at least one of the bridge 622 and the legs 624.

[0080] 21-22, an implant system 700 is shown in accordance with one exemplary embodiment. The implant system 700 may be of various sizes and may, for example, include one or more components of various sizes and complementary components of complementary sizes (e.g., may include staple implants having various heights and widths and insertion tools configured to removably couple to the staple implants).

[0081] In the illustrated example, the implant system 700 includes an insertion tool 702 (hereinafter referred to as "inserter 702"). The inserter 702 is releasably connectable to an implant 720 (e.g., a staple) (hereinafter referred to as "staple 720"). The inserter 702 and staple 720 may be provided to a physician or other healthcare provider (healthcare facility) in a connected configuration (e.g., as shown in FIGS. 21-22) or in a separate configuration. If provided in a separate configuration, the physician or other healthcare provider may releasably connect (e.g., engage) the inserter 702 to the staple 720 prior to using or performing a procedure in which the implant system 700 and its components may be implemented. Additionally, the inserter 702 may be configured to releasably connect and disconnect multiple staples 720 in succession, and as a result, may be configured as a multi-purpose tool. For example, a physician may releasably couple a first staple 720 to the inserter 702, then detach and implant the first staple 720, subsequently detachably couple a second staple 720 to the inserter 702, and finally detach and implant the second staple 720. Both the inserter 702 and the staples 720 may be similarly configured and / or compatible with the implant systems and components described herein above.

[0082] The inserter 702, in the illustrated example, includes an upper portion 704 and a lower portion 706. The upper portion 704 is disposed substantially opposite the lower portion 706. As illustrated, the staple 720 is configured to removably couple to a portion of the lower portion 706 of the inserter 702. That is, the upper portion 704 is disposed on the opposite side of the inserter 702 from the portion of the inserter 702 to which the staple 720 is coupled. In some embodiments, one or both of the upper portion 704 and lower portion 706 of the inserter 702 may be provided with one or more ergonomic features, such as a geometric contour configured to facilitate gripping and manipulation (actuation) of the inserter 702 and its components. As illustrated, the upper portion 704 and lower portion 706 are integral with one another. However, in some embodiments, the upper portion 704 and lower portion 706 may be removably, hinged, or otherwise coupled to one another.

[0083] The lower portion 706 is provided with an actuator 708 that extends laterally from a side of the lower portion 706 in the illustrated example. As illustrated, the actuator 708 is integral with the lower portion 706, but is movable relative to the lower portion 706. The actuator 708 is shaped such that the width of the actuator 708 increases as the actuator 708 extends from the lower portion 706. The actuator 708 extends from the lower portion 706 to define a volume (e.g., a space, an opening, etc.) 710 located between at least a portion of the actuator 708 and the lower portion 706. The actuator 708 is operable over a range of motion that includes at least the position shown in FIGS. 21-22 (non-actuated position) and a position (actuated position) in which at least a portion of the actuator 708 occupies at least a portion of the volume 710. The actuator 708 may be formed from a resilient material and / or may be structured such that a force must be applied to operate the actuator 708 from the non-actuated position to the actuated position. Further, a force may be required to hold the actuator 708 in the actuated position, and in the absence of such force, the actuator 708 may be configured to return to the unactuated position.

[0084] The actuator 708 is operable to pivot about a pivot point 712 ("hinge point" in some embodiments). The pivot point 712 is located at or adjacent to a location on the lower portion 706 from which the actuator 708 extends laterally. In some embodiments, the pivot point 712 may be located at a portion of the lower portion 706 that is narrower in width (e.g., lateral dimension) than the actuator 708. Additionally, the pivot point 712 is located substantially below the volume 710.

[0085] The lower portion 706 further includes another volume portion (e.g., a space, an opening, etc.) 716 in the illustrated example. The volume portion 716 is defined in the upper direction by the lower portion 706 and in the lateral direction by a pair of retainers 718. In the illustrated example, each retainer 718 extends downward from a bottom of the lower portion 706 and has a substantially curved or "hook-like" shape. The retainers 718 are curved toward the midline of the inserter 702 (e.g., toward the volume portion 716). The illustrated volume portion 716 does not have a lower boundary (e.g., opposite the portion defined by the bottom of the lower portion 706 when the inserter 702 is in an unbounded state with respect to the staple 720). As illustrated, the volume portion 716 has an elongated shape (defined by three sides) with a width dimension greater than its height dimension.

[0086] As shown in FIGS. 21-22, the volume 716 is configured to receive the bridge 722 of the staple 720 when the staple 720 is in a mated configuration with the inserter 702. In some embodiments, the staple 720 may be manipulated (actuated) from a first position (e.g., a position where the bridge 722 is in a substantially curved shape) to a second position (e.g., a position where the bridge 722 is in a substantially straight shape) prior to mating with the inserter 702. In some embodiments, a force may be required to manipulate the staple 720 and its bridge 722 from the first position to the second position. As shown, the mating includes at least partially disposing the bridge 722 of the staple 720 (in the aforementioned substantially straight shape) within the volume 716 of the inserter 702.

[0087] The staple 720 has a pair of legs 724 extending from the bridge 722 at a substantially perpendicular angle relative to a bottom surface of the bridge 722 in the illustrated example. In the first position, the pair of legs 724 may be disposed at a substantially oblique angle relative to one another. However, in the second position (e.g., a position in which the staple 720 is held coupled to the inserter 702), the pair of legs 724 may be substantially parallel to one another. The legs 724 have a roughened surface (texture) 726 disposed on an inner surface thereof in the illustrated example. As shown in FIGS. 21-22, the roughened surface 726 has a sawtooth (tooth) configuration, although in some embodiments, the roughened surface 726 may have alternative shapes and configurations.

[0088] The legs 724 extend downwardly from the bottom surface of the bridge 722 adjacent the ends of the bridge 722, except that each end of the bridge 722 is configured to extend laterally beyond the point from which the legs 724 extend. The aforementioned ends (e.g., protrusions, overhangs, shoulders, etc.) of the bridge 722 are configured to engage the retaining portions 718 of the inserter 702 when the staple 720 is in the coupled position shown in FIGS. 21-22. During coupling of the staple 720 to the inserter 702, the staple 720 may be manipulated (actuated) to a second position (where the bridge 722 is generally straight) such that a portion of the bridge 722 is inserted into the volume portion 716. This causes the ends of the bridge 722 to abut against the retaining portions 718 such that the retaining portions 718 exert a force on the ends of the bridge 722 to hold the bridge 722 in the generally straight position.

[0089] During insertion, the actuator 708 of the inserter 702 may be manipulated (actuated) such that at least a portion of the actuator 708 occupies at least a portion of the volume 710, and in response, the retainer 718 integral with the actuator 708 disengages from the end of the bridge 722 with which the retainer 718 was engaged. The inserter 702 may be manipulated (actuated) (e.g., twisted, pivoted, hinged, etc.) to release the staple 720 from the volume 716 (releasing the end of the bridge 722 from the retainer 718 on the opposite (second) side from the actuator 708), thereby allowing the staple 720 to return to the first position (with the pair of legs 724 forming an oblique angle with respect to one another and the bridge 722 assuming a substantially curved shape). In the second position, the staple 720 may exert a compressive force via at least one of the bridge 722 and the legs 724.

[0090] 23-30, an implant 800 (hereinafter "staple 800") according to one exemplary embodiment is shown. Staple 800 may be interchangeable with one or more implant systems and / or components thereof described hereinabove. Additionally, staple 800 may be interchangeable with various other systems and components common to orthopaedic surgery. In some embodiments, staple 800 may have features (including, but not limited to, those shown and described herein) that may facilitate said interchangeability by releasable coupling, engagement, actuation, etc.

[0091] The staple 800, in the illustrated example, includes a pair of legs 802 extending from a bridge 804. When the staple 800 is in the exemplary position of FIG. 23, the pair of legs 802 form an oblique angle with respect to one another. The legs 802 are tapered along their length. The distal end of the legs 802 has a smaller width (thickness) than the portion adjacent the bridge 804. Each leg 802, in the illustrated example, extends from the bridge 804 adjacent the distal end of the bridge 804. This forms a shoulder 808 at each end of the bridge 804 that extends from the legs 802 to the terminus of the bridge 804. The shoulders 808 may be configured to facilitate a releasable connection with an instrument (e.g., one or more of the inserters 102, 202, 302, 402, 502, 602 shown and described herein). The leg portion 802, in the illustrated example, has a texture 806 disposed on its inner surface. As shown in Figures 23-30, the texture 806 has a sawtooth (tooth) configuration (although in alternative embodiments, the texture 806 may have other texture shapes or configurations).

[0092] Staple 800, in the illustrated example, has a transition portion 810 between bridge 804 and each leg 802. Transition portion 810 is disposed between the midline of staple 800 and shoulder 808. Transition portion 810 has a rounded shape (curvature). The radius of curvature of transition portion 810 can vary depending on the size of staple 800 (the angle formed between the pair of legs 802 will be smaller the larger the radius of curvature of transition portion 810 is, and vice versa).

[0093] The upper surface of the bridge 804 of the staple 800 has a central portion 812 and a pair of side edges 814. The central portion 812 is disposed between the pair of side edges 814 and extends along the entire upper surface of the bridge 804 from one shoulder 808 to the other shoulder 808. As shown, the central portion 812 has a generally hourglass shape. The pair of side edges 814 are disposed symmetrically on either side of the central portion 812, and each has a generally semicircular shape (less than a semicircle or less than a semiellipse, as shown).

[0094] The staple 800 may be configured to be operable (e.g., movable) between a first position, shown in FIG. 23, and a second position in which the bridge 804 transitions from a substantially curved shape to a substantially straight (linear) shape (where the pair of legs 802 no longer form an oblique angle with respect to one another). The staple 800 may be held in the second position by one or more insertion instruments, including those previously shown and described herein (inserters 102, 202, 302, 402, 502, 602). Additionally, the shoulder 808 may be configured to receive a force applied to bias the bridge 804 in a direction from the first position toward the second position (and in some embodiments, to hold the bridge 804 in said second position).

[0095] The terms used herein are for the purpose of describing particular embodiments only and are not intended to be limiting of the invention. Countable nouns used herein include the singular as well as the plural unless otherwise specified. Additionally, the terms "comprise", "have", and "include" are intended to be interpreted as open-ended verbs. As a result, a method or device that "comprises", "has", or "includes" one or more steps or elements includes, but is not limited to, only, that one or more steps or elements. Similarly, a method step or device element that "comprises", "has", or "includes" one or more features includes, but is not limited to, only that one or more features. Additionally, a device or structure that is configured in a particular way may be configured in at least that way, but in ways not mentioned.

[0096] The present invention has been described with reference to the preferred embodiments described above. The structural and operational embodiments described herein are merely examples of some of the multiple possible configurations for providing the same general functions and characteristics and general system operation. In light of the above detailed description, changes and modifications to the above-described embodiments may be made as appropriate. It is intended that the present invention be construed as including all such changes and modifications.

Claims

1. 1. An orthopedic implant system comprising: an insertion tool having an actuator and a retention mechanism; an orthopedic implant configured to be releasably coupled to the retention feature of the insertion tool and to be detached from the insertion tool in response to operation of the actuator; An implant system comprising:

2. The insertion tool comprises an upper portion and a lower portion; The upper and lower portions are integral with each other. The implant system of claim 1 .

3. the actuator is integral with the lower portion of the insertion instrument; The implant system of claim 2.

4. The actuator extends laterally from the bottom of the insertion instrument. The implant system according to claim 3.

5. the retention feature extends from a bottom portion of the insertion instrument; The holding mechanism includes a pair of holding portions. The implant system of claim 1 .

6. The pair of holding portions are disposed on both sides of the bottom of the insertion tool. The implant system according to claim 5.

7. the insertion tool has a volume defined vertically by the lower portion of the insertion tool and laterally by the pair of retaining portions; The implant system according to claim 6.

8. Each of the retaining portions has a curved shape extending toward the volume portion. The implant system according to claim 7.

9. The volume is configured to receive and retain at least a portion of the implant. The implant system according to claim 8.

10. The actuator is operated to operate at least one of the retainers to couple and detach the implant to the insertion tool.

10. An implant system according to claim 9.

11. The implant comprises an orthopedic staple. The implant system of claim 1 .

12. The staple is a bridge having a pair of shoulders disposed at opposite ends thereof; a pair of legs extending from the bridge; one of the legs is disposed between one of the shoulders and a midline of the bridge; the other leg is disposed between the other shoulder and the midline of the bridge; The implant system of claim 11.

13. 1. A surgical instrument comprising: An upper portion and a lower portion integrally provided on the opposite side of the upper portion, The lower portion includes an actuator extending from the lower portion along a side surface thereof, and a pair of holding portions extending from a bottom portion of the lower portion toward an opposite side to the upper portion, Each of the pair of holding portions has a curved shape toward the midline of the instrument. Equipment.

14. a first volume at least partially defined by a side of the instrument and a side of the actuator; 14. The device of claim 13.

15. the actuator is operatively configured such that at least a portion of the actuator occupies at least a portion of the first volume.

15. The device of claim 14.

16. The actuator is pivotable relative to the lower portion of the instrument.

16. The device of claim 15.

17. A lateral dimension of a second volume portion defined laterally by the pair of holding portions is configured to be changeable by operation of the actuator.

17. The apparatus of claim 16.

18. 1. An orthopedic staple-type implant, comprising: A bridge and a pair of legs extending from a bottom surface of the bridge, Each of the legs includes a roughened portion located on an inner surface thereof and a terminal portion. Implant.

19. The implant is movable between a first position in which the bridge is in a curved configuration and a second position in which the bridge is in a straight configuration.

20. The implant of claim 18.

20. each said leg extending from a bottom surface of said bridge at a location between a midline of said bridge and a distal end of said bridge; 20. The implant of claim 18.

21. each said leg having a tapered thickness; the thickness being greater adjacent the bridge than adjacent the distal ends of the legs; 21. The implant of claim 20.

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