Devices for manipulating orthopedic compression implants

Abstract

A device for manipulating an orthopedic implant includes a base graspable by a user, a bending assembly including a pin having an outer surface extending between a first end of the pin that is coupled to the base and an opposing second end of the pin, and a gripper coupled to the outer surface of the pin and including a jaw, and a slider coupled to the bending assembly and slidable relative to the bending assembly to shift the jaw of the gripper between a flexed state for gripping an orthopedic implant and an unflexed state for releasing the orthopedic implant.

Description

DEVICES FOR MANIPULATING ORTHOPEDIC COMPRESSION IMPLANTSCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims benefit of U.S. provisional patent application Serial No. 63 / 677,871 filed July 31 , 2024, and entitled "Devices for Manipulating Orthopedic Compression Implants," which is hereby incorporated herein by reference in its entirety for all purposes.STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

[0002] Not applicable.BACKGROUND

[0003] Staple-style orthopedic implants are often used to provide fixation and stability at a fracture, osteotomy or arthrodesis site to enable fusion. Some orthopedic implants are shape memory compression implants that may change dimensions to offer greater fixation and stability to enable improved fusion.BRIEF SUMMARY

[0004] An embodiment of a device for manipulating an orthopedic implant comprises a base graspable by a user, a bending assembly comprising a pin having an outer surface extending between a first end of the pin that is coupled to the base and an opposing second end of the pin, and a gripper coupled to the outer surface of the pin and comprising a jaw, and a slider coupled to the bending assembly and slidable relative to the bending assembly to shift the jaw of the gripper between a flexed state for gripping an orthopedic implant and an unflexed state for releasing the orthopedic implant. In some embodiments, the pin is translatable relative to the gripper to apply a central bending load to an orthopedic implant received in the jaw of the gripper. In some embodiments, the pin is threadably coupled to the gripper such that relative rotation between the pin and the gripper results in relative longitudinal translation of the gripper and the pin. In certain embodiments, the jaw comprises an opposing pair of flexible gripper fingers each extending between a fixed end coupled to the pin and an opposing free end. In certain embodiments, the base comprises a manually graspable handle. In some embodiments, the base is rotationally locked to the pin ofthe bending assembly. In some embodiments, the device comprises a bending state in which the pin is configured to apply a first longitudinally directed force to an orthopedic implant gripped by the jaw in the flexed state while the gripper is configured to apply a second longitudinally directed force to the implant that is opposed to the first longitudinally directed force. In certain embodiments, the first longitudinally directed force and the second longitudinally directed force are spaced along a lateral axis of the device. In certain embodiments, the slider comprises a central passage in which the pin is slidably received and an outer passage in which the jaw is slidably received. An embodiment of an implant kit comprises the device, an orthopedic implant, and a retention block assembly having a receptacle in which the orthopedic implant is loadable.

[0005] An embodiment of a device for manipulating an orthopedic implant comprises a base graspable by a user, a bending assembly comprising a pin having an outer surface extending between a first end of the pin that is coupled to the base and an opposing second end of the pin, and a gripper coupled to the outer surface of the pin and comprising a laterally spaced pair of jaws for selectably gripping an orthopedic implant, and a slider coupled to the bending assembly and extending between a first end proximal the base and an opposing second end distal the base wherein the second end of the pin and the jaw each project outwardly from the second end of the base with the pin positioned laterally between the pair of jaws. In some embodiments, the second end of the pin is translatable in a first longitudinal direction relative to the gripper in response to relative rotation between the base and the slider. In some embodiments, each of the pair of jaws comprises an opposing pair of flexible gripper fingers each extending between a fixed end coupled to the pin and an opposing free end. In certain embodiments, the device comprises a bending state in which the pin is configured to apply a first longitudinally directed force to an orthopedic implant gripped by the pair of jaws while the gripper is configured to apply a second longitudinally directed force to the implant that is opposed to the first longitudinally directed force. In certain embodiments, the first longitudinally directed force and the second longitudinally directed force are spaced along a lateral axis of the device.

[0006] An embodiment of a device for manipulating an orthopedic implant comprises a base graspable by a user, a bending assembly comprising a pin having an outer surface extending between a first end of the pin that is coupled to the base and an opposing second end of the pin, and a gripper coupled to the outer surface of the pinand comprising a jaw for selectably gripping an orthopedic implant, and a slider coupled to the bending assembly and extending between a first end proximal the base and an opposing second end distal the base wherein the second end of the pin and the jaw each project outwardly from the second end of the base, and wherein slider is slidable in a first longitudinal direction over the outer surface of the pin to retract the jaw into the second end of the slider. In some embodiments, the slider forms an internal passage in which the jaw is slidably positioned, the internal passage defined by a shoulder configured to contact the jaw in response to displacement of the slider in the first longitudinal direction to shift the jaw between a flexed state and an unflexed state. In some embodiments, the pin is rotationally locked to the base and is threadably coupled to the gripper, the gripper being rotationally locked to the slider. In certain embodiments, the second end of the pin is shiftable in the first longitudinal direction relative to the jaw in response to relative rotation of the base and the gripper. In certain embodiments, the pin is translatable relative to the gripper to apply a central bending load to an orthopedic implant received in the jaw of the gripper.

[0007] Embodiments described herein comprise a combination of features and characteristics intended to address various shortcomings associated with certain prior devices, systems, and methods. The foregoing has outlined rather broadly the features and technical characteristics of the disclosed embodiments in order that the detailed description that follows may be better understood. The various characteristics and features described above, as well as others, will be readily apparent to those skilled in the art upon reading the following detailed description, and by referring to the accompanying drawings. It should be appreciated that the conception and the specific embodiments disclosed may be readily utilized as a basis for modifying or designing other structures for carrying out the same purposes as the disclosed embodiments. It should also be realized that such equivalent constructions do not depart from the spirit and scope of the principles disclosed herein.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] For a detailed description of various exemplary embodiments, reference will now be made to the accompanying drawings in which:

[0009] FIG. 1 is an isometric view of an embodiment of an implant for compressing two bone segments together in accordance with the principles described herein;

[0010] FIG. 2 is an isometric view of the implant of FIG. 1 ;

[0011] FIG. 3 is a front view of the implant of FIG. 2;

[0012] FIG. 4 is an isometric view of an embodiment of a manipulation device for manipulating embodiments of implants disclosed herein in accordance with the principles described herein;

[0013] FIG. 5 is a side view of the manipulation device of FIG. 4;

[0014] FIG. 6 is a bottom view of the manipulation device of FIG. 4;

[0015] FIG. 7 is an exploded view of the manipulation device of FIG. 4;

[0016] FIGS. 8 and 9 are front views of the manipulation device of FIG. 4;

[0017] FIG. 10 is another isometric view of the manipulation device of FIG. 4;

[0018] FIG. 11 is an isometric view of an embodiment of a gripper of the manipulation device of FIG. 4 in accordance with the principles disclosed herein;

[0019] FIG. 12 is a top view of the gripper of FIG. 11 ;

[0020] FIG. 13 is a side view of the gripper of FIG. 11 ;

[0021] FIG. 14 is a front view of the gripper of FIG. 11 ;

[0022] FIG. 15 is a rear view of the gripper of FIG. 11 ;

[0023] FIG. 16 is a front view of the manipulation device of FIG. 4 in an initial state in accordance with the principles disclosed herein;

[0024] FIG. 17 is a front cross-sectional view of the manipulation device of FIG. 4 in the initial state;

[0025] FIGS. 18 and 19 are side cross-sectional views of the manipulation device of FIG. 4 in the initial state;

[0026] FIG. 20 is a front view of the manipulation device of FIG. 4 in a capture state in accordance with the principles disclosed herein;

[0027] FIG. 21 is a front cross-sectional view of the manipulation device of FIG. 4 in the capture state;

[0028] FIGS. 22 and 23 are side cross-sectional views of the manipulation device of FIG. 4 in the capture state;

[0029] FIG. 24 is a front view of the manipulation device of FIG. 4 in a bending state in accordance with the principles disclosed herein;

[0030] FIG. 25 is a front cross-sectional view of the manipulation device of FIG. 4 in the bending state;

[0031] FIGS. 26 and 27 are side cross-sectional views of the manipulation device of FIG. 4 in the bending state;

[0032] FIG. 28 is another front view of the manipulation device of FIG. 4 in the bending state;

[0033] FIG. 29 is another front cross-sectional view of the manipulation device of FIG. 4 in the bending state;

[0034] FIGS. 30 and 31 are additional side cross-sectional views of the manipulation device of FIG. 4 in the bending state;

[0035] FIGS. 32-35 are additional front views of the manipulation device of FIG. 4; and

[0036] FIG. 36 is an isometric view of an embodiment of an implant kit in accordance with the principles disclosed herein.DETAILED DESCRIPTION

[0037] The following discussion is directed to various exemplary embodiments. However, one of ordinary skill in the art will understand that the examples disclosed herein have broad application, and that the discussion of any embodiment is meant only to be exemplary of that embodiment, and not intended to suggest that the scope of the disclosure, including the claims, is limited to that embodiment.

[0038] The drawing figures are not necessarily to scale. Certain features and components herein may be shown exaggerated in scale or in somewhat schematic form and some details of conventional elements may not be shown in interest of clarity and conciseness.

[0039] In the following discussion and in the claims, the terms “including” and “comprising” are used in an open-ended fashion, and thus should be interpreted to mean “including, but not limited to... .” Also, the term “couple” or “couples” is intended to mean either an indirect or direct connection. Thus, if a first device couples to a second device, that connection may be through a direct connection of the two devices, or through an indirect connection that is established via other devices, components, nodes, and connections. In addition, as used herein, the terms “axial” and “axially” generally mean along or parallel to a given axis (e.g., central axis of a body or a port), while the terms “radial” and “radially” generally mean perpendicular to the given axis. For instance, an axial distance refers to a distance measured along or parallel to the axis, and a radial distance means a distance measured perpendicular to the axis. As used herein, the terms “approximately,” “about,” “substantially,” and the like mean within 10% (i.e., plus or minus 10%) of the recited value. Thus, for example, a recited angle of “about 80 degrees” refers to an angle ranging from 72 degrees to 88 degrees.

[0040] Unless the context dictates the contrary, all ranges set forth herein should be interpreted as being inclusive of their endpoints, and open-ended ranges should be interpreted to include only commercially practical values. Similarly, all lists of values should be considered as inclusive of intermediate values unless the context indicates the contrary.

[0041] As previously described above, staple-style orthopedic implants are designed to provide fixation and stability at a fracture, osteotomy, or arthrodesis site to enable fusion. Such implants may include 2, 3, 4 or more legs. The legs of the implant extend from a bridge that may come in various forms, sizes and shapes depending on the particular application and anatomy. The implants are often part of system that includes instruments for use with the implants and an associated surgical technique. The instruments may include for example: sizing guides / templates, drill guides, drill or drilling pins, locating pins / pull pins, tamps, insertion tools, removal tools, and possibly heat source instruments for shape memory alloys.

[0042] There are generally three types of orthopedic staple-style implants: (1) static staples, (2) mechanical compression staples, and (3) shape memory compression staples. Static staples generally represent the first-generation orthopedic bone staples. These basic, U-shaped staples are typically made from medical grade titanium or stainless-steel materials suitable for medical device application. Traditional milling, wire- EDM, or wire-bending methods are usually employed to manufacture static staples. Static staples usually provide minimal to no compression to an osteotomy or arthrodesis site, and provide minimal stability to promote fusion at the site. Mechanical compression staples are typically manufactured from stainless steel materials. These staples rely on the application of an external force to achieve compression between bone fragments at an osteotomy or arthrodesis site. In particular, by physically bending the bridge with a suitable instrument, the distance between the implant legs is shortened, thereby allowing the legs to provide compression therebetween. Due to the limited elasticity of stainless steel, the compression provided is relatively short-lived. In addition, the deformation of the bridge may cause the tips of the implant legs to splay resulting in the distraction of the bone segments.

[0043] Shape memory compression staples are often made from medical grade Nitinol suitable for medical device applications. Nitinol is a metal alloy made of approximately half nickel and half titanium. Nitinol exhibits phase transformation whereby the molecular arrangement of Nitinol can vary according to the temperatures to which it is exposed. Atlower temperatures, the crystalline architecture of Nitinol resembles an accordion making it relatively unstable, malleable, and weak. This is referred to as the martensitic phase of Nitinol (martensite). At higher temperatures, the crystalline structure of Nitinol is rearranged into a cubic form making it contracted, rigid, and strong. This is referred to as the austenitic phase of Nitinol (austenite). The temperature range at which Nitinol transforms from the martensitic phase into austenitic phase can be adjusted and manipulated through manufacturing processes. During manufacturing, a Nitinol device undergoes heat treatments that “program” the temperature ranges that trigger the transition between the martensitic and austenitic phases. For example, when a Nitinol device is heated, the programing dictates the beginning of the phase transformation from martensite to austenite (Austenite Start temperature or As) and the end of the transformation (Austenite Finish temperature or Af). In addition, when a Nitinol device is cooled, the programming dictates the beginning of the phase transformation from austenite to martensite (Martensite Start temperature or Ms) and the end of the transformation (Martensite Finish temperature or Mf). In addition to the aforementioned phase transformation, Nitinol exhibits shape memory and superelastic / pseudoelastic characteristics.

[0044] With regards to shape memory, a Nitinol device can be designed to transform from one shape to another when exposed to heat. For example, prior to heat treating, the Nitinol device may be cooled, and thus become malleable in the martensite material phase and shaped into a particular form that imparts internal residual stresses. Heat treatment can then be applied, which sets or “bakes” this established shape into the memory of the implant. Then, when the Nitinol device is heated through its transformation temperature range, the device will revert to its predetermined final shape as it undergoes the phase transformation to Austenite.

[0045] Compared to most other metals, Nitinol can withstand a large amount of strain, for example up to 8%, and still recover its original shape. The superelastic characteristic is displayed when a Nitinol staple is warmed through its transformation temperature range but is constrained and prevented from returning to its original shape. While constrained in a deformed shape, as is the case when a Nitinol bone staple is in bone, continuous exposure to sufficient heat allows the implant to behave like an elastic spring. This superelastic effect thus may be used to maintaining a long-term compressive force between bone segments over a large displacement range.

[0046] There are two varieties of staples are made from Nitinol: Thermally-activated and Superelastic. The transition temperature ranges of these types of implants vary and can be classified as either heat-activated or body temperature-activated. Heat-activated Nitinol bone staples have an Asand Af above body temperature. These implants are inserted into bone in the malleable martensitic phase and are exposed to an external heat via electrocautery or bi-polar electrical resistance to convert the implant from martensite to austenite, and thus, promote shape change that creates initial compression between joined bone segments. Compression is maintained through the superelastic effect as the implant is constrained in an open position by the bone segments. Body temperature-activated Nitinol bone staples have a transition temperature range that is slightly lower than body temperature. Since their austenite start temperature (As) may be at or below room temperature, these implants may utilize freezer storage to prevent premature closure. These implants are placed into the osteotomy or arthrodesis site while still in a frozen state, and then compress the joined bone segments through the shape memory effect as they warm to body temperature. Compression is again maintained through the superelastic effect as the implant is constrained in an open position by the bone segments. Both types of thermally-activated Nitinol implants (e.g., heat- and body temperature-activated) have not, however, been widely accepted. Due to manufacturing limitations of thermally-activated Nitinol, traditional machining methods (milling, grinding, turning, etc.) have generally not been cost-effective. Thus, many Nitinol staples are created using raw Nitinol wire material that is bent to the desired shape and heat treated to set the shape. This has generally limited implant geometries to simple U-shaped staples having two legs and a constant cross-section between the distal ends of the implant legs.

[0047] Superelastic shape memory compression staples are the latest generation of Nitinol bone implants. The austenite finish temperature (Af) for these implants is significantly below room temperature, for example 10 to -20 degrees C, thus freezer storage to maintain an initial shape in the martensite material phase may not be sufficient, as implants may begin to deflect before being placed into the osteotomy or arthrodesis site. Thus, in some instances, external constraint devices may be used to mechanically open and constrain the legs of the implant prior to inserting them into pre-drilled holes in bone. Upon release of the constraining tool, the superelastic effect is transferred from the tool to the bone to achieve compression across the osteotomy or arthrodesis site.

[0048] Due to a relatively low Af (e.g., 10 to -20 degrees C), superelastic Nitinol implants may utilize different manufacturing approaches as compared to implants made from wire raw material, and thus, may include more configurations and geometries, such as additional staple legs. For example, starting with bulk raw material with low Af, implants may be machined using wire Electrical Discharge Machining (EDM) to create the desired shapes. The shapes of these implants are however limited to the shapes that may result from the intersection of wire paths from two planes, and thus, such implants may not conform to the complex anatomies of the body. Additionally, due to the EDM manufacturing process, the leg features typically have square or rectangular cross- sectional shapes that do not match the shape and size of the round drilled holes in which the legs are installed. A result of this mismatch is that the implant leg strength may not be maximized, and thus, the most common fracture location of a staple is in the leg features. This typically limits the use of staples to applications in lower biomechanical loading areas. However, as staples become more common practice for surgeons, there is a continued desire to use staples in high biomechanical loading applications.

[0049] Accordingly, embodiments disclosed herein include staple-style implants that may be produced with more complex geometries than what is typically possible with EDM machining. In particular, some embodiments disclosed herein may utilize advanced milling techniques and or electrochemical machining (ECM) to produce implants having non-rectangular legs, such as rounded or partially rounded legs, that maximize strength within a given drilled hole. In addition, some embodiments disclosed herein may include implant bridges that have a different cross-sectional shapes than the corresponding legs. In particular, the cross-section of the bridge may include a partially rounded profile that provides a low implant profile and establishes a more anatomically conforming fit. Moreover, in some embodiments, the cross-section of the bridge and / or the crosssection of the legs are non-rectangular (e.g., elliptical, D-shaped, circular, semi-circular, or polygonal).

[0050] Referring now to FIG. 1 , an embodiment of a staple-style implant 100 is shown. In this embodiment, implant 100 is a U-shaped staple used to fix, stabilize, and apply compression (illustrated with arrows 18 in FIG. 1 ) to a fracture or break 12 between a first bone segment 2 and a second bone segment 4 of a broken bone. Each bone segment 2, 4 has a curved outer surface or profile 7, 9, respectively, proximal implant 100. Bone segments 2, 4 represent an exemplary curved profile (e.g., round, elliptical, etc.) such as that of a generally cylindrical long bone (e.g., femora, tibiae, humeri, ulnae,metacarpals, clavicle, etc.), however, as will be described more fully below, implant 100 may be used with any classification of bone (e.g., short, flat, sutural, irregular, sesamoid, or long), and in locations with or without a curved profile. Although break 12 is shown generally along a plane oriented perpendicular to curved profiles 7, 9, in general, break 12 may be positioned at any angle with respect to curved profiles 7, 9.

[0051] In this embodiment, implant 100 includes a bridge 110 and a plurality of legs 130 extending from bridge 110. When secured to bone segments 2, 4, bridge 110 extends across or spans break 12, while legs 130 penetrate into corresponding bone segments 2, 4 via holes 14, 16, respectively. In particular, a first hole 14 is drilled into first bone segment 2 and a second hole 16 is drilled into second bone segment 4. First hole 14 has a linear central or longitudinal axis 15 and second hole 16 has a linear central or longitudinal axis 25 that is spaced apart from and oriented parallel to the central axis 15 of first hole 14. Legs 130 are pressed into and secured within holes 14, 16 via an interference fit, and maintain static positions relative to bone segments 2, 4, as elastic energy stored within implant 100 applies compression 18 across the break 12.

[0052] Referring now to FIGS. 2 and 3, implant 100 has a central axis 105 passing through the geometric center of bridge 110 and centered between legs 130 in front view (FIG. 3). In addition, bridge 110 has a curved central or longitudinal axis 115, a first terminal end 110a, and a second terminal end 110b opposite end 110a. Each leg 130 extends from bridge 110, and in particular, extends from a corresponding end 110a, 110b of bridge 110. Each leg 130 has a central or longitudinal axis 135 laterally spaced apart from central axis 105, a first or fixed end 130a fixably attached to and integral with the corresponding end 110a, 110b of bridge 110, and a second or free end 130b that is distal bridge 110. In this embodiment, each central axis 135 is linear, longitudinal axis 115 of bridge 110 intersects axes 105, 135, and axes 105, 115, 135 lie in a common plane. For purposes of clarity and further explanation, the common plane within which axes 105, 115, 135 are disposed may also be referred to herein as the “reference plane.” In FIG. 3, the reference plane is a plane oriented parallel to the sheet of paper on which the drawing is shown.

[0053] As best shown in FIG. 3, each leg 130 is oriented at a leg angle a measured between the corresponding axis 135 and central axis 105 in the reference plane (in front view of FIG. 3). In embodiments described herein, leg angle a of each leg 130 ranges from about 0 degrees to about 20 degrees, alternatively ranges from about 0 degrees to about 15 degrees, and alternatively ranges from about 0 degrees to about 10degrees. In embodiments where the leg angles a are greater than 0 degrees, such as that shown in FIGS. 2 and 3, free ends 130b of legs 130 are positioned closer to central axis 105 than proximal ends 130a, the legs 130 may be referred to herein as “inwardly biased.” Thus, in some embodiments, linear central axis 135 of the first leg 130 is not parallel to linear central axis 135 of the second leg 130. In general, the leg angles a of the legs 130 may be the same or different. In this embodiment, each leg angle a is an acute angle between 0 degrees and 10 degrees, legs 130 are inwardly biased, and each leg angle a is the same.

[0054] Referring now to FIG. 3, as previously described, central axis 115 of bridge 110 is curved. In general, the central axis 115 may have a constant or variable radius of curvature Rus measured in the reference plane in front view (FIG. 3) from a point along central axis 105 to central axis 115 of bridge 110. In embodiments described herein, the radius of curvature Rus of central axis 115 at any point along central axis 115 can range from about 0 mm (i.e., linear) to about 200 mm, alternatively range from about 15 mm to about 20 mm, and more alternatively range from about 20 mm to about 30 mm. It should be appreciated that the radius of curvature Rus of central axis 115 can vary along its length between ends 110a, 110b or be constant along its length between ends 110a, 110b.

[0055] Referring again to FIGS. 2 and 3, each leg 130 has a radially outer surface 131 extending axially (relative to corresponding axis 135) between ends 130a, 130b, a plurality of axially spaced serrations 138 disposed along outer surface 131 , and a bevel 140 disposed along outer surface 131 at end 130b.

[0056] As best shown in FIG. 2, each leg 130 has a cross-section 134 taken in a plane oriented perpendicular to the corresponding axis 135. In cross-section 134, outer surface 131 defines a non-rectangular outer shape or circular profile 136. In this embodiment, outer surface 131 of each leg 130 is a cylindrical surface extending axially (relative to corresponding axis 135) from end 130a to end 130b, and thus, circular profile 136 at cross-section 134 is circular (FIG. 2). As described in more detail below, in some applications, the cylindrical shapes of the legs of an implant (e.g., cylindrical outer surface 131 of legs 130) may be advantageous as the cylindrical geometry can more fully fill the drilled hole (as shown in FIG. 1 at holes 14, 16), as compared to a rectangular prismatic geometry, and thus, offers the potential for enhanced bending strength and fixation within the bone segments (e.g., bone segments 2, 4). More specifically, rectangular cross-sectional dimensions of legshaving a rectangular prismatic shape are limited as the sharp corners of the crosssection contact the cylindrical inner surface of the bone defined by the drilled hole, and any increases in one of the cross-sectional dimensions of the rectangular crosssection may result in sufficient interference between the legs and bone segments to restrict insertion of the legs into the bone segments.

[0057] Although legs 130 have cylindrical outer surfaces 131 defining circular profiles 136 in cross-sections 134 taken perpendicular to axes 135 in this embodiment, in other embodiments, the legs (e.g., legs 130) may have outer surfaces with other geometries that define other non-rectangular profiles (e.g., circular profiles 136) in cross-sections taken perpendicular to the central axes of the legs (e.g., such as polygons, semicircular, elliptical, etc. along cross-section 134).

[0058] In this embodiment, outer surface 131 of each leg 130 is cylindrical, and thus, a leg taper angle 0 measured from central axis 135 to outer surface 131 of each leg130 in the reference plane in front view (FIG. 3) is zero at all points along the axis 135. However, in other embodiments, the outer surface of each leg (e.g., outer surface 131 of each leg 130) is frustoconical and characterized by a non-zero leg taper angle 0. In embodiments described herein, leg taper angle 0 ranges from 0 degrees to about 2.5 degrees, alternatively ranges from about 0.075 degrees to about 1.5 degrees, and alternatively ranges from about 0.125 degrees to about 1.25 degrees. In some applications, a non-zero taper angle 0 may be advantageously facilitate a wedging fit between the legs and a cylindrically shaped drilled hole, which may enhance the retention of the implant with the bone segments. In addition, non-zero taper angles 0 may allow a narrower tip (e.g., tip 132), which may aid in insertion of the leg into holes 14, 16 (as shown in FIG. 1 ), while allowing an increased diameter at the fixed ends of the legs to increase the bending strength at the joints between the legs and the bridge (e.g., bridge 110).

[0059] Referring still to FIGS. 2 and 3, serrations 138 are axially spaced (relative to corresponding axis 135) between ends 130a, 130b and provided along outer surface131 on the inside of each leg 130 (i.e., along the sides of legs 130 that face toward each other and axis 105). In this embodiment, each serration 138 is defined by a planar sloped surface 138a that slopes radially inward toward the corresponding axis 135 moving axially toward end 130b of the corresponding leg 130, and an upward facing planar shoulder 138b extending radially inward from the sloped surface toward axis 135 of the corresponding leg 130. One bevel 140 is provided along outer surface131 on the outside of each leg 130 (i.e., along the sides of legs 130 that face away from each other and axis 105), and extends from end 130b of each leg 130. Bevel 140 is a planar surface. The planar sloped surface 138a on the inside of each leg 130 at end 130b and the bevel 140 on the outside of each leg 130 define tapered tips 132 at ends 130b of legs 130.

[0060] As best shown in FIG. 2, bridge 110 has a radially outer surface 111 extending axially (relative to axis 115) from end 110a to end 110b. In addition, bridge 110 has a cross-section 116 taken in a plane oriented perpendicular to axis 115. In cross-section 116, outer surface 111 of bridge 110 defines a non-rectangular outer shape or profile 119. In this embodiment, profile 119 at cross-section 116 is generally D-shaped. In particular, outer surface 111 includes a first or upper surface 112, a second or lower surface 114, and a pair of fillets or lateral surfaces 118 extending from upper surface 112 to lower surface 114. Upper surface 112 and lower surface 1 14 are oriented parallel to each other and central axis 115 in the front view (FIG. 3). As previously described, axis 1 15 is curved, and thus, upper surface 112 is a convex surface, whereas lower surface 114 is a concave surface. In a cross-section of bridge 110 taken in a plane oriented perpendicular to axis 1 15 (e.g., cross-section 116), bridge 110 has an outer profile defined by outer surface 111 that is flat along upper surface 112 and flat along lower surface 114. Fillets 118 are curved, convex surfaces extending axially from end 110a to end 110b. Although the outer profile of bridge 110 defined by outer surface 11 1 that is flat along upper surface 112 and flat along lower surface 114 in a cross-section taken in a plan oriented perpendicular to axis 115, in other embodiments, the distinct upper surface (e.g., upper surface 112) is eliminated such that the fillets (e.g., fillets 118) meet at the top of the bridge, and in yet other embodiments, the lower surface (e.g., lower surface 114) may include a concavity, fillet, or notch that extends inward towards the central axis of the bridge (e.g., towards central axis 115).

[0061] Although bridge 110 has an outer surface 111 defining D-shaped profiles 119 in cross-sections 116 taken perpendicular to axis 115 in this embodiment, in other embodiments, the bridge (e.g., bridge 110) may have an outer surface with a geometry that defines other non-rectangular profiles (e.g., profiles 1 19) in cross-sections taken perpendicular to the central axes of the bridge (e.g., such as polygonal, semi-circular, elliptical, circular, etc.). In addition, the non-rectangular profile of the legs (e.g., legs 130) in cross-sections taken perpendicular to the central axes of the legs may be thesame or different from the non-rectangular profile of the bridge in cross-sections taken perpendicular to the central axis of the bridge. For example, as previously described, in this embodiment, each leg 130 has a circular profile 136 in cross-sections 134 taken in planes oriented perpendicular to axes 135 and bridge 110 has a D-shaped profile 119 in cross-sections 116 taken in a plane perpendicular to axis 115.

[0062] In this embodiment, the cross-sectional area of the bridge 110 in any plane oriented perpendicular to axis 115 (e.g., cross-section 116) is equal to or greater than the cross-sectional area of each leg 130 taken in any plane oriented perpendicular to axis 135 (e.g., cross-section 134). In embodiments described herein, the ratio of (i) the cross-sectional area of the bridge (e.g., bridge 110) in any plane oriented perpendicular to the central axis of the bridge (e.g., axis 115) to (ii) the cross-sectional area of each leg (e.g., leg 130) in any plane oriented perpendicular to the central axis of the leg (e.g., axis 135) is 1.0 to 10.0, alternatively about 1.5 to 3.0, and alternatively about 1 .5 to 2.0.

[0063] As described further below, in some applications, the D-shaped cross-section of bridge 110 and the radius of curvature Rus between ends 110a, 110b in the reference plane provide a conforming fit along the generally convex, cylindrical outer surface of a bone (as shown in FIG. 1 ). Without being limited to this or any other theory, the lower surface 114 defining a generally flat profile in cross-sectional view in a plane oriented perpendicular to axis 115 may reduce the height to which the implant 100 extends from the bone segments 2, 4, while the upper surface 112 having a generally curved convex profile in cross-sectional view in a plane oriented perpendicular to axis 115 may provide a smooth, gradual transition to minimizes irritation of soft tissue adjacent the bone.

[0064] Referring again to FIGS. 2 and 3, as described above, legs 130 and bridge 110 have different cross-sectional geometries. To smoothly blend legs 130 and bridge 110 where fixed ends 130a of legs 130 meet lower surface 1 14 of bridge 110, in this embodiment, implant 100 includes smoothly curved concave transition surfaces 144 between fixed ends 130a and lower surface 114. Adjacent transition surfaces 144 and proximal ends 130a of legs 130, the portion of each end 110a, 110b of bridge 110 that extends laterally (relative to the reference plane) beyond legs 130 along lower surface 114 includes a pair of laterally opposed, downward facing planar shoulders 142 and a pair of laterally opposed, downward facing concave cavities or tool engagement recesses 146. In this embodiment, shoulders 142 are oriented perpendicular to thereference plane and tool engagement recesses 146 have semi-cylindrical geometries. As will be described in more detail below, shoulders 142 and / or tool engagement recesses 146 are sized and positioned to mate and engage with a device for manipulating, inserting, or positioning implant 100. Accordingly, shoulders 142 and tool engagement recesses 146 may also be described as tool engagement shoulders 142 and tool engagement recesses 146, respectively.

[0065] At each end 110a, 110b, the pair of shoulders 142 and the pair of tool engagement recesses 146 are disposed on opposite sides of axis 115 and the reference plane. Thus, it should be appreciated that although only two shoulders 142 and two tool engagement recesses 146 are shown in the front view of FIG. 3, four shoulders 142 and four tool engagement recesses 146 are included as implant 100 is symmetric about the reference plane, and thus, two additional shoulders 142 and two additional tool engagement recesses 146 are included along the opposite side of implant 100. Shoulders 142 and tool engagement recesses 146 may be useful in reducing bending stress concentrations and may be used to grip implant 100 with a surgical insertion or retaining tool. In particular, and as will be described in more detail below, forces may be applied to implant 100 at shoulders 142 and / or tool engagement recesses 146 to restrain or impart bending moments into bridge 110.

[0066] In this embodiment, implant 100 is made of a Nitinol material, and thus, can be heat treated and programed, as discussed above, to have shape memory and superelastic / pseudoelastic characteristics such that implant 100 may be classified as a superelastic shape memory implant, and may transform (in some embodiments) from one shape to another when exposed to heat. In other embodiments, implant may be elastically deformed or flexed between different shapes or biased into different shapes without exposure to heat.

[0067] Referring now to FIGS. 1- 3, the surgical use of implant 100 may, in some embodiments, utilize the shape memory characteristics of Nitinol to impart compressive loads across a fracture, osteotomy, or arthrodesis site (e.g., compression 18 across break 12 as shown in FIG. 1 ) to enable fusion. In the manner previously described, implant 100 can be made of Nitinol and programed though deformation and heat treatment, such that the shape memory of the Nitinol material increases leg angle a (e.g. ends 130b move inward toward axis 105) and / or translates ends 110a, 110b of bridge 110 towards central axis 105 in response to heating of implant 100. Such heating of implant 100 may be accomplished with an external source (e.g., heat-activated), oras implant 100 is brought to room temperature or body temperature (e.g., body temperature-activated). In some embodiments, the implant 100 may be superelastic.

[0068] In addition, in some embodiments, the shape transformation may have already occurred and an external tool may be used to restrain the deformation of implant 100. For example, in some embodiments, the external tool may engage with a plurality of shoulders 142 and / or with a plurality of tool engagement recesses 146, and apply forces to bridge 110 to elastically flex bridge 110 at ends 110a, 110b to bring axes 135 into parallel with central axis 105 to reduce each leg angle a. Thus, in some embodiments, legs 130 may be constrained with axes 135 oriented parallel and coaxially aligned with central axes 15, 25 of holes 14, 16 in bone segments 2, 4, respectively (as shown in FIG. 1 ), and then inserted into corresponding holes 14, 16. Legs 130 are advanced into holes 14, 16 until lower surface 114 of bridge 110 is pressed into contact (or approximate contact) with bone segments 2, 4, as the curvature of bridge 110 may be specifically designed and selected to accommodate the underlying curved profiles 7, 9 of bone segments 2, 4 to allow a low implant profile and establish an anatomically conforming fit. Next, the external tool may be removed, to release the strain energy of the elastically deformed implant 100 and allow legs 130 to apply compression across break 12 as the free ends 130b of legs and / or ends 110a, 110b of bridge 110 are biased inward toward central axis 105.

[0069] The implant 100 shown in FIGS. 1-3 is only exemplary and the configuration of implant 100 may vary significantly in other embodiments. For example, in some embodiments, rather than being defined by cylindrical outer surface 131 , legs 130 may instead be defined by semi-cylindrical surfaces whereby, for instance, legs 130 may be provided with a D-shaped and other cross-sectional profiles that are not necessarily circular. In other embodiments, rather than having a single pair of legs 130, implant 100 may include multiple pairs of legs 130 and / or other pairs of legs that differ in configuration from the legs 130 shown in FIG. 1-3 and which extend from bridge 110 of implant 100.

[0070] In general, embodiments of staple-style implants disclosed herein (e.g., implant 100) can be held, retained, manipulated, and installed in bone or other anatomical site using suitable and compatible devices or instruments. Exemplary embodiments of devices that can be used to hold, retain, manipulate, or install embodiments of implants disclosed herein will now be described. Such exemplary embodiments will be shown and described in connection with implant 100 previously described, however, it shouldbe appreciated that the exemplary embodiments can be used with other embodiments of staple-style implants such as implant 100.

[0071] Referring now to FIGS. 4-10, embodiments of a manipulation device for holding, manipulating, removing, repositioning, or installing staple-style implant 100 is shown. As will be described in more detail below, manipulation device 200 can be operated by a surgeon or other user to receive an implant 100 held by retention block assembly 350 and securely hold implant 100 such as during removal, repositioning, or installation in bone segments 2, 4, and selectively release implant 100 after installation in bone segments 2, 4. Thus, manipulation device 200 may be described has having a first or closed configuration for securely gripping and holding implant 100 (e.g., for and during installation), and a second or open configuration for disengaging and releasing implant 100 (e.g. following installation).

[0072] .Manipulation device 200 has a central or longitudinal axis 205, a first or proximal end 201 , a second or distal end 203 opposite proximal end 201 , and a pair of lateral sides 207 extending axially from proximal end 201 to distal end 203. In this exemplary embodiment, manipulation device 200 has a central or longitudinal axis 205 and includes a base 210, a bending assembly 230 coupled to base 210, and a sleeve or slider 270 slidably disposed about base 210 and bending assembly 230.

[0073] Base 210 of manipulation device 200 extends longitudinally (e.g., aligned with central axis 205) between a first or proximal end 211 and an opposing second or distal end 213. The proximal end 21 1 of base 210 defines the proximal end 201 of manipulation device 200. In this exemplary embodiment, the proximal end 211 of base 210 defines a handle 212 of base 210 including a pair of gripping surfaces or simply grips 214 extending along the lateral sides 207 of handle 212 for facilitating the manual grasping of handle 212 by a user of manipulation device 200. In other embodiments, the shape or configuration of handle 212 of base 210 may vary from that shown in FIGS. 4-10. Additionally, in this exemplary embodiment, base 210 defines a central opening or receptacle 216 that extends at least partially into the distal end 213 of base 210. As will be discussed further herein, a portion of the bending assembly 230 of manipulation device 200 is received in the central opening 216 of base 210 to couple base 210 with bending assembly 230. Particularly, in this exemplary embodiment, a fastener in the form of a connector pin 218 extending laterally through the central opening 216 couples the bending assembly 230 with base 210. In other embodiments,bending assembly 230 may be coupled to base 210 via a variety of different arrangements.

[0074] Referring to FIGS. 11 -15, the bending assembly 230 of manipulation device 200 has a central or longitudinal axis aligned or coincident with central axis 205 of manipulation device 200 and generally comprises a central pin 240 and a gripper 250 coupled to the central pin 240. The central pin 240 of bending assembly 230 extends longitudinally between a first or proximal end 241 (defining a proximal end of the bending assembly 230 in this exemplary embodiment) and an opposing second or distal end 243. Central pin 240 has a generally cylindrical outer surface extending between ends 241 and 243 thereof and which comprises an externally threaded section or simply external threads 242 that extend over a non-zero longitudinal length of central pin 240 between ends 241 and 243. In this exemplary embodiment, external threads 242 extend over only a portion of the longitudinal length of central pin 240 which may vary (e.g., they may extend entirely across central pin 240) in other embodiments.

[0075] The gripper 250 of bending assembly 230 extends longitudinally between a first or proximal end 251 and an opposing second or distal end 253 (defining a distal end of the bending assembly 230 in this exemplary embodiment). In this exemplary embodiment, gripper 250 comprises a carrier 252 located at the proximal end 251 thereof and a plurality of flexible gripper fingers 256 (shown as gripper fingers 256-1 and 256-2 in FIGS. 11 -15). In this exemplary embodiment, carrier 252 defines an internally threaded opening or passage 254 through which the external threads 242 through which central pin 240 extends. Particularly, external threads 242 of central pin 240 threadably engage with the internally threaded passage 254 of carrier 252 to form a threaded connection between central pin 240 and gripper 250.

[0076] In this exemplary embodiment, rotation of central pin 240 relative to gripper 250 about central axis 205 results in longitudinal displacement of gripper250 (e.g., in either of opposing longitudinal directions 221 and 223 extending parallel central axis 205 shown in FIG. 4). For instance, rotation in a first angular direction (e.g., counterclockwise) may result in longitudinal displacement in a first or distal direction 221 along central axis 205 relative to central pin 240 while rotation in an opposing second angular direction (e.g., clockwise) may result in longitudinal displacement in an opposing second or proximal direction 223 along central axis 205 relative to central pin 240. Additionally, in this exemplary embodiment, the proximal end 241 of centralpin 240 is rotationally locked to base 210 by connector pin 218 such that rotation of base 210 produces a corresponding rotation of the central pin 240 relative to gripper 250. In this manner, handle 212 of base 210 may be conveniently gripped by a user of manipulation device 200 for rotating the central pin 240 and thereby longitudinally displacing gripper 250 relative to central pin 240 (along with base 210).

[0077] Each gripper finger 256 of gripper 250 extends longitudinally between a first or fixed end coupled to carrier 252 and a second or free end (coincident with or defining the distal end 253 of gripper 250) opposite the fixed end and which is permitted to flex along a laterally extending medial axis 225 (shown in FIG. 6) that is orthogonal central axis 205 and extends centrally between lateral sides 207 of manipulation device 200. Additionally, in this exemplary embodiment, gripper 250 comprises two corresponding pairs of opposing gripper fingers 256-1 and 256-2, respectively, with each pair of gripper fingers 256-1 and 256-2 defining a jaw 255 (shown as jaws 255-1 and 255-2 in FIGS. 11-15) located along each lateral side 207 and having a corresponding opening 257 (shown as openings 257-1 and 257-2 in FIGS. 11-15) extending along the medial axis 225. As will be discussed further herein, an implant 100 is receivable in the openings 257 formed between the pair of jaws 255 of gripper 250 to releasably couple the implant 100 to the manipulation device 200.

[0078] In this exemplary embodiment, each gripper finger 256 comprises a laterally outer (e.g., along medial axis 225) surface defining a groove or recess 258 extending longitudinally along the gripper finger 256 between a first or proximal end or shoulder 260 (e.g., nearest proximal end 251 of gripper 250) and an opposing second or distal end or shoulder 262 (e.g., nearest distal end 253 of gripper 250). Additionally, in this exemplary embodiment, the free ends of gripper fingers 256 define or form claws 264 in the form of shoulders that extend inwards along medial axis 225 towards the central axis 205 of manipulation device 200. Claws 264 act to trap the bridge 110 of implant between the jaws 255-1 / 255-2 of gripper 250 when gripper 250 is in a closed configuration as will be discussed further herein.

[0079] Referring to FIGS. 16-19, the slider 270 of manipulation device 200 extends longitudinally (e.g., aligned with central axis 205) between a first or proximal end 271 and an opposing second or distal end 273. Slider 270 includes a longitudinal passage 272 extending longitudinally entirely between ends 271 and 273. Additionally, slider 270 comprises a central guide or centralizer 274 extending longitudinally along central axis 205 and located at or defining the distal end 273 of slider 270. Centralizer 274divides the longitudinal passage 272 of slider 270 at the distal end 273 thereof into a central passage 276 and a pair of laterally outer passages 278 spaced laterally from central passage 276 towards the lateral sides 207 of slider 270. Further, in this exemplary embodiment, each outer passage 278 is defined by a pair of shoulders 280 projecting inwards along medial axis 225 towards central axis 205.

[0080] In this exemplary embodiment, bending assembly 230 extends through the longitudinal passage 272 of slider 270. Particularly, carrier 252 of the gripper 250 of bending assembly 230 is received in longitudinal passage 272 whereby relative rotation between gripper 250 and slider 270 is restricted. Thus, rotation of base 210 may result in longitudinal displacement of base 210 relative to both gripper 250 and slider 270. Additionally, the central pin 240 of gripper 250 is slidably received in the central passage 276 of slider 270 while jaws 255-1 and 255-2 are similarly slidably received in the corresponding outer passages 278 of slider 270. Particularly, in this exemplary embodiment, shoulders 280 of outer passages 278 are received in the corresponding recesses 258 of gripper fingers 256. In this exemplary embodiment, slider 270 may be manually slid or reciprocated longitudinally over the gripper 250 (e.g., manually by gripping the slider 270 by hand) in directions 221 and 223 with shoulders 280 travelling along or through recesses 258. Shoulders 280 may interfere with the corresponding shoulders 260 and 262 of recesses 258 whereby contact between terminal ends of shoulders 280 and the corresponding shoulders 260 and 262 of recesses 258 delimits the extend of relative longitudinal travel between slider 270 and gripper 250.

[0081] Additionally, in this exemplary embodiment, the portions of gripper fingers 256 proximal the distal end 253 flare outwards along medial axis 225 and away from central axis 205 such that a first or open width of the opening 257 of a given jaw 255 is greater than the width of the corresponding outer passage 278 of slider 270 when the gripper fingers 256-1 and 256-2 of the given jaw 255 are in an unflexed or medially outwards state as shown in FIGS. 16-19. Thus, by sliding slider 270 in the distal direction 221 relative to gripper 250 the jaws 255-1 / 255-2 of gripper 250 may be at least partially retracted into their corresponding outer passages 278 whereby contact between shoulders 280 and the outer surfaces of gripper fingers 256-1 / 256-2 forces each gripper finger 256-1 / 256-2 of each jaw 255 inwards along medial axis 225 towards central axis 205 in a flexed or medially inwards state of the jaw 255. In the flexed state of a given jaw 255, the opening 257 of the jaw 255 is contracted along medial axis 225providing the opening 257 with a second or closed width that is less than the open width of opening 257. Additionally, in this exemplary embodiment, the gripper fingers256-1 / 256-2 of each jaw 255-1 / 255-2 are biased (e.g., mechanically via the inherent flexibility of gripper fingers 256) towards their unflexed states such that an external force (e.g., provided by slider 270) is required to maintain jaws 255 in their corresponding flexed states.

[0082] Referring generally to FIGS. 16-31 , exemplary aspects of manners in which manipulation device 200 may be operated by a user to install, remove, reposition, or otherwise manipulate an orthopedic implant (e.g., implant 100) will now be discussed. Particularly, FIGS. 16-19 illustrate manipulation device 200 aligned with an exemplary implant 100 with jaws 255-1 / 255-2 of gripper 250 in their unflexed states. In this arrangement, the bridge 110 of implant 100 is receivable in the openings 257-1 / 257-2 formed between jaws 255-1 / 255-2 with the first widths of openings 257-1 / 257-2 being comparable with or greater than a corresponding width of the bridge 110 of implant 100.

[0083] FIGS. 20-23 illustrate manipulation device 200 in a second or capture state in which slider 270 has been slid longitudinally (e.g., manually by the user of manipulation device 200) in the distal direction 221 along central axis 205 relative to base 210 and bending assembly 230. The movement of slider 270 in the distal direction 221 forces each jaw 255-1 / 255-2 from its unflexed state towards or into its corresponding flexed state thereby capturing and securing the bridge 110 of implant within the openings257-1 / 257-2 of jaws 255-1 / 255-2. Particularly, interference along medial axis 225 between shoulders 280 of outer passages 278 and the outer surfaces of gripper fingers 256-1 / 256-2 prevents jaws 255-1 / 255-2 from returning to their unflexed states such that longitudinally directed (e.g., directed along central axis 205) loads may be transferred to the implant 100 from the manipulation device 200 via contact between the implant 100 and the claws 264 of each jaw 255-1 / 255-2.

[0084] In the capture state of manipulation device 200 shown in FIGS. 20-23, the distal end 243 of central pin 240 may be spaced from or located adjacent the bridge 110 of implant 100 whereby no significant longitudinally directed loads are applied by central pin 240 to the implant 100. FIGS. 24-27 illustrate manipulation device 200 in a third or bending state in which central pin 240 has been advanced longitudinally in the distal direction 221 relative to gripper 250 whereby a bending load is applied by the distal end 243 of central pin 240 centrally to the bridge 110 of implant 100. Particularly,with manipulation device 200 in the capture state shown in FIGS. 20-23, base 210 may be rotated about central axis 205 (e.g., manually via the user grasping handle 212) thereby rotating central pin 240 about central axis 205 relative to gripper 250 to produce (e.g., via threaded engagement between external threads 242 and the internally threaded passage 254 of carrier 252) movement of central pin 240 in the distal direction 221 relative to gripper 250.

[0085] In the bending state shown in FIGS. 24-27, manipulation device 200 applies three separate longitudinally directed loads to the implant 100 including a central load applied by the distal end 243 of central pin 240 in the distal direction 221 and a pair of laterally outer loads applied by the claws 224 of jaws 255-1 / 255-2 in the proximal direction 223. The outer loads are spaced from the central load along a lateral axis 227 (shown in FIG. 6) intersecting and extending orthogonal to both the central axis 205 and medial axis 225. For example, the central load may be applied to a center of the bridge 110 of implant 100 while the outer loads may be applied proximal ends 1 10a and 110b of bridge 110 such that a resulting combined three-point bend is applied to the implant 100 by manipulation device 200 urging the legs 130 outwards along lateral axis 227.

[0086] The three-point bend induced in implant 100 by manipulation device 200 when in the bending state reduces or relaxes the interference formed between legs 130 of implant 100 and the inner surfaces of holes 14 and 16 of corresponding bone segments 2 and 4, respectively. In other words, the three-point bend induced in implant 100 frees the implant from bone segments 2 and 4 whereby a sufficient force applied to manipulation device 200 in the proximal direction 223 may result in the freeing and removal of legs 130 from holes 14 and 16 as shown in FIGS. 28-31.

[0087] While FIGS. 16-31 described above illustrate an exemplary technique for removing an implant 100 from a pair of bone segments 2 and 4 using manipulation device 200, manipulation device 200 may be used for manipulating implants 100 (or other orthopedic implants) in other manners. For example, and referring now to FIGS. 32-35, an exemplary technique for repositioning an implant 100 with respect to bone segments 2 and 4 using manipulation device 200 is shown. When repositioning an implant 100, the manipulation device 200 may be coupled to a free implant 100 while in the bending state. Once aligned with a pair of selected holes formed in bone segments 2 and 4, the legs 130 of implant 100 may be inserted into the holes with manipulation device 200 remaining in the bending state as shown particularly in FIG.33. Manipulation device 200 may then be shifted from the bending state to the capture state by rotating base 210 in the opposite rotational direction to thereby retract the distal end 243 of central pin 240 in the proximal direction 223 to release the three- point bend previously applied by manipulation device 200 to implant 100 when in the bending state. Following the transition of manipulation device 200 to the capture state, manipulation device 200 may be shifted into the initial state by sliding the slider 270 in the proximal direction 223 relative to gripper 250 as shown in FIG. 34. With manipulation device 200 in the initial state, manipulation device 200 may be physically removed from the implant 100 as shown in FIG. 35.

[0088] Referring to FIG. 36, in some embodiments, manipulation device 200 forms a part of a shippable implant kit 300 also including a retention or transfer block assembly 350 preloaded with an implant 100. Retention block assembly 350 is generally configured to hold or retain an implant (e.g., implant 100) such that the implant may be transferred to a manipulation device (e.g., manipulation device 200). Particularly, retention block assembly 350 is configured for holding the inwardly biased legs 130 of implant 100 in parallel and transferring the implant 100 to manipulation device 200 with the legs 130 in parallel. In general, retention block assembly 350 can be used to support and maintain legs 130 in parallel during shipping, handling, storage, and transfer to another device such as manipulation device 200, which will be described in more detail below. For instance, retention block assembly 350 may be preloaded with an implant 100 as part of the implant kit 300 also comprising the manipulation device 200. In this exemplary embodiment, retention block assembly 350 is a two-component structure including a block body 360 and a base or keystone 370 which may slidably couple to the block body 360 when the retention block assembly 350 is in an assembled configuration as shown in FIG. 36.

[0089] In the manner described, embodiments disclosed herein include staple-style implants that may include rounded or partially rounded legs that maximize strength within a given drilled hole. In addition, some embodiments disclosed herein include implant bridges which have a different cross-sectional shape than the corresponding legs. In particular, the cross-section of the bridge may include a partially rounded profile that provides a low implant profile and establishes a more anatomically conforming fit. Embodiments of devices for holding, positioning, and / or installing staple-style implants are also disclosed herein.

[0090] While exemplary embodiments have been shown and described, modifications thereof can be made by one skilled in the art without departing from the scope or teachings herein. The embodiments described herein are exemplary only and are not limiting. Many variations and modifications of the systems, apparatus, and processes described herein are possible and are within the scope of the disclosure. Accordingly, the scope of protection is not limited to the embodiments described herein, but is only limited by the claims that follow, the scope of which shall include all equivalents of the subject matter of the claims. Unless expressly stated otherwise, the steps in a method claim may be performed in any order. The recitation of identifiers such as (a), (b), (c) or (1 ), (2), (3) before steps in a method claim are not intended to and do not specify a particular order to the steps, but rather are used to simplify subsequent reference to such steps.

Claims

CLAIMSWhat is claimed is:1 . A device for manipulating an orthopedic implant, comprising: a base graspable by a user; a bending assembly comprising a pin having an outer surface extending between a first end of the pin that is coupled to the base and an opposing second end of the pin, and a gripper coupled to the outer surface of the pin and comprising a jaw; and a slider coupled to the bending assembly and slidable relative to the bending assembly to shift the jaw of the gripper between a flexed state for gripping an orthopedic implant and an unflexed state for releasing the orthopedic implant.

2. The device of claim 1 , wherein the pin is translatable relative to the gripper to apply a central bending load to the orthopedic implant received in the jaw of the gripper.

3. The device of claim 2, wherein the pin is threadably coupled to the gripper such that relative rotation between the pin and the gripper results in relative longitudinal translation of the gripper and the pin.

4. The device of claim 1 , wherein the jaw comprises an opposing pair of flexible gripper fingers each extending between a fixed end coupled to the pin and an opposing free end.

5. The device of claim 1 , wherein the base comprises a manually graspable handle.

6. The device of claim 1 , wherein the base is rotationally locked to the pin of the bending assembly.

7. The device of claim 1 , wherein the device comprises a bending state in which the pin is configured to apply a first longitudinally directed force to the orthopedic implant gripped by the jaw when in the flexed state while the gripper is configured to apply a second longitudinally directed force to the implant that is opposed to the first longitudinally directed force.

8. The device of claim 7, wherein the first longitudinally directed force and the second longitudinally directed force are spaced along a lateral axis of the device.

9. The device of claim 1 , wherein the slider comprises a central passage in which the pin is slidably received and an outer passage in which the jaw is slidably received.

10. An implant kit, comprising: the device of claim 1 ; the orthopedic implant; and a retention block assembly having a receptacle in which the orthopedic implant is loadable.

11. A device for manipulating an orthopedic implant, comprising: a base graspable by a user; a bending assembly comprising a pin having an outer surface extending between a first end of the pin that is coupled to the base and an opposing second end of the pin, and a gripper coupled to the outer surface of the pin and comprising a laterally spaced pair of jaws for selectably gripping an orthopedic implant; and a slider coupled to the bending assembly and extending between a first end proximal the base and an opposing second end distal the base wherein the second end of the pin and the jaw each project outwardly from the second end of the base with the pin positioned laterally between the pair of jaws.

12. The device of claim 11 , wherein the second end of the pin is translatable in a first longitudinal direction relative to the gripper in response to relative rotation between the base and the slider.

13. The device of claim 11 , wherein each of the pair of jaws comprises an opposing pair of flexible gripper fingers each extending between a fixed end coupled to the pin and an opposing free end.

14. The device of claim 11 , wherein the device comprises a bending state in which the pin is configured to apply a first longitudinally directed force to the orthopedic implantgripped by the pair of jaws while the gripper is configured to apply a second longitudinally directed force to the orthopedic implant that is opposed to the first longitudinally directed force.

15. The device of claim 14, wherein the first longitudinally directed force and the second longitudinally directed force are spaced along a lateral axis of the device.

16. A device for manipulating an orthopedic implant, comprising: a base graspable by a user; a bending assembly comprising a pin having an outer surface extending between a first end of the pin that is coupled to the base and an opposing second end of the pin, and a gripper coupled to the outer surface of the pin and comprising a jaw for selectably gripping an orthopedic implant; and a slider coupled to the bending assembly and extending between a first end proximal the base and an opposing second end distal the base wherein the second end of the pin and the jaw each project outwardly from the second end of the base, and wherein slider is slidable in a first longitudinal direction over the outer surface of the pin to retract the jaw into the second end of the slider.

17. The device of claim 16, wherein the slider forms an internal passage in which the jaw is slidably positioned, the internal passage defined by a shoulder configured to contact the jaw in response to displacement of the slider in the first longitudinal direction to shift the jaw between a flexed state and an unflexed state.

18. The device of claim 16, wherein the pin is rotationally locked to the base and is threadably coupled to the gripper, the gripper being rotationally locked to the slider.

19. The device of claim 18, wherein the second end of the pin is shiftable in the first longitudinal direction relative to the jaw in response to relative rotation of the base and the gripper.

20. The device of claim 16, wherein the pin is translatable relative to the gripper to apply a central bending load to the orthopedic implant received in the jaw of the gripper.

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