Intramedullary implant and method of use

A bone implant includes a proximal end, a distal end, a first portion extending between the proximal and distal ends having a maximum and minimum portion height, and a second portion extending between the proximal and distal ends having a maximum and minimum portion height. The second portion is connected to the first portion at the proximal end and the distal end and at least one of the first portion and the second portion is moveable relative to the other of the first portion and the second portion so as to transition the bone implant between a relaxed state wherein the first and second portions are separated by a first distance and a contracted state wherein the first and second portions are separated by a second distance different from the first distance. At least one of the proximal end and the distal end have the minimum portion height.

BACKGROUND OF THE INVENTION

The present disclosure relates generally to bone pins, and more particularly, to intramedullary implants which fix bones with respect to each other. In particular, the present disclosure relates to arthrodesis and osteosynthesis procedures in which bone portions, or two adjacent bones, are fused together.

An arthrodesis or osteosynthesis procedure is typically performed to improve stability and to place or maintain in compression two bone parts or bone fragments that should be consolidated. Stability is a critical factor for obtaining fusion of bone parts, while minimizing the attendant problems such as pain, swelling, etc. A compressive action on the bone portions serves to fuse the bones more rapidly in the position selected by the operator, such as the surgeon, during the operation.

Various technical solutions have been proposed for carrying out an arthrodesis, particularly in the foot, the hand, the wrist, etc. Historically, implants such as, for example, staples (with or without shape memory characteristics) and simple K-wires have been used, as have implants that may have shape memory or may otherwise be expandable. Certain of these implants can produce the compression beneficial to fusion of bone portions, but oftentimes can be difficult to implant. For instance, such implant can be difficult to manipulate in the surgical area, difficult to implant into bone, and/or difficult to orient properly in bone. As such, a need exists for an improved implant and instrumentation that provides the needed compression of the bones while also providing a simplified insertion technique.

BRIEF SUMMARY OF THE INVENTION

In one aspect of the present disclosure, a bone implant includes a proximal end, a distal end, a first portion extending between the proximal and distal ends having a maximum portion height and a minimum portion height, and a second portion extending between the proximal and distal ends having a maximum portion height and a minimum portion height. The second portion is connected to the first portion at the proximal end and the distal end and at least one of the first portion and the second portion is moveable relative to the other of the first portion and the second portion so as to transition the bone implant between a relaxed state wherein the first and second portions are separated by a first distance and a contracted state wherein the first and second portions are separated by a second distance different from the first distance. At least one of the proximal end and the distal end have the minimum portion height.

Additionally, the implant may also include an anchor element on at least one of the first portion and the second portion. The anchor element may be a plurality of barbs extending from at least one of the first and second portions. Of the plurality of barbs, a first set of barbs may be positioned adjacent the proximal end of the implant and extend from their respective first and second portions so that ends of the first set of barbs face a first direction, and a second set barbs may be positioned adjacent the distal end of the implant and extend from their respective first and second portions so that ends thereof face in a second direction opposite the first direction. Moreover, the first and second portions may taper outwardly from the proximal and distal ends so that a maximum width of the implant is positioned between the proximal and distal ends. The first and second portions may each include an engagement surface for engaging an instrument. The engagement surfaces of the first and second portions may be disposed at a location of the maximum width of the implant and between the first and second sets of barbs.

Continuing with this aspect, the first and second portions may be biased away from each other so that the bone implant is configured to be transitioned to or maintained in the contracted state via engagement with an instrument at a single contact point on each of the first portion and the second portion. The first and second portions may be bent along their length so that the proximal end is oblique to the distal end. Also, the implant may further include a first flange extending from the first portion towards the second portion and a second flange extending from the second portion towards the first portion. The first and second flange members may be spaced from one another when in the relaxed state and contact one another when in the contracted state. The first and second flanges may extend from inner surfaces of the first and second portions and may be located along a length of the first and second portions at a position of maximum width of the bone implant.

Furthermore, the proximal end may have a width greater than a width of the distal end. Also, the first and second portions may define a channel extending between the first and second portions and towards the proximal and distal ends. The channel may be adapted to accept a guide wire therein. The channel may be defined between inner surfaces of the first and second portions and upper surfaces of the proximal and distal ends.

In another aspect of the present disclosure, a bone implant includes a monolithic bone implant including first and second elongate portions and proximal and distal end portions. The first and second elongate portions each connect to the proximal and distal end portions so as to form a gap that is confined between the first and second elongate portions and proximal and distal end portions. The first and second elongate portions and proximal and distal end portions also define a channel that extends along a length of the implant from the distal end portion to the proximal end portion. The channel is configured to slidingly receive a guide wire.

Additionally, the gap may be defined by inner surfaces of the first and second elongate portions and inner surfaces of the proximal and distal end portions. The channel may be defined by inner surfaces of the first and second elongate portions and upper surfaces of the distal and proximal end portions.

In a further aspect of the present disclosure, a bone implant, includes a proximal end, a distal end, a first portion, a second portion connected to the first portion at the proximal and distal ends of the bone implant, a first flange extending from the first portion towards the second portion, and a second flange extending from the second portion towards the first portion. The first and second portions are biased away from each other and have a relaxed state where the first flange and second flange are separated by a first distance and a contracted state wherein the first flange and the second flange are separated by a second distance different from the first distance.

Additionally, the first and second portions may have a portion height, the proximal and distal ends of the implant may have an end height, and the first and second flanges may have a flange height smaller than the portion height. Also, the implant may include a channel defined between the first and second portions. The channel may have a height defined by the difference between the portion height and the flange height. Moreover, the implant may further include a channel defined between the first and second portions and within the portion height. Such channel may end above the end height at the proximal and/or distal end where the end height may be smaller than the portion height.

DETAILED DESCRIPTION

The implants, instructions and associated systems, kits, and methods, of the present disclosure are intended for use in tissue, in particular bone. While many of the exemplary methods disclosed herein are directed towards a use in a specific anatomy, such as the hand or foot, other uses, some of which are described herein, are also envisioned. As used herein, unless otherwise designated, “proximal” or “proximally” means closer to or towards an operator, e.g., surgeon, while “distal” or “distally” means further from or away from the operator. As used herein, the term “substantially” means to meet the criteria in such measure that one skilled in the art would understand that the benefit to be achieved, or the condition or property value desired, is met. As used herein, the term “about” shall be construed as a modifying term or value such that the amount so modified is not an absolute in order to take into account, at the very least, the degree of experimental error, technique error, instrument error, and the like commonly experienced in measuring values. Similarly, any ranges cited herein shall include the endpoints, including those that recite a range “between” two values.

The implants disclosed herein are generally intramedullary implants intended to aid in interphalangeal joint arthrodesis to correct anatomical issues, such as for example hammer-toe and other similar deformities, or to aid in osteosynthesis of two portions of a bone. In one exemplary use, this device may be utilized for arthrodesis of the bones of the toes or fingers, though its use in other anatomical locations is also envisioned. The general purpose of this type of implant, for example, is to hold two bones in place while fusion of the two bones occurs. As such, a portion of the device may be inserted in one of the bones (e.g., the proximal phalanx), and the remaining portion may be inserted into the other bone to be fused (e.g., the middle phalanx).

In one embodiment,FIGS. 1-4illustrate a bone implant70having a first portion72and a second portion74. The first and second elongate portions72,74are separated by a space76when the implant70is in a relaxed state as best seen inFIG. 2. A first flange78extends from the first portion72and a second flange80extends from the second portion74. When in the relaxed state as shown inFIG. 2, the flanges78,80are separated from one another. As illustrated inFIG. 3, the first flange78may extend towards the second portion74and the second flange80may extend towards the first portion72such that the flanges can be opposite one another and facing one another. The first and second portions72,74are connected at a proximal end82and a distal end84to form proximal and distal end portions or noses of implant70, and is thus of monolithic construction, though the implant70could alternatively be separate and connectable portions. The first and second portions72,74include a portion height94while the proximal and distal ends82,84include an end height96. Any of these heights can be different from any of the others, or alternatively they can all be of equal height to one another. As illustrated inFIGS. 2 and 3, for example, the portion height94is the same for both the first and second portion and is taller than the end height96at both the proximal and distal ends. Further, the end height96at both the proximal and distal end can be the same, or as illustrated, one may be taller than the other.

The implant70is compressible such that it can transition between the relaxed state shown inFIG. 2and a compressed state shown inFIG. 4. Preferably, the implant70has a “spring-like” characteristic such that the implant can be compressed through application of a force on the implant, but upon release of such force, the implant can “spring” back to its relaxed state. Such application of force may be performed by pressing the first and second portions72,74towards one another using a surgeon's hand or a tool. To this end, the implant70may also have an engagement surface90on the first and second portions72,74. The engagement surface90can be positioned between a proximal portion88and a distal portion86of the implant70, or anywhere else as desired. In particular, the engagement surfaces90may be positioned along the first and second portions72,74where implant70is at its maximum width while said implant70is in a relaxed state, as best shown inFIG. 2. The engagement surface90can be shaped to be engaged by a tool, or alternatively provides a position for application of force by hand. Furthermore, the location of the engagement surface90allows a single tool, positioned at a single location of the first and second portions, to simultaneously transition the distal portion86and proximal portion88of the implant70between the relaxed state and the compressed state, though more than one tool may be used.

The first and second portions72,74are separated by a reduced space76′ when the implant70is in the compressed state. The flanges78,80are shown inFIG. 4as adjacent to, but not in contact with, each other. Of course, the flanges could also contact one another when the implant is in the compressed state. The size of the flanges78,80can be adjusted as desired to change the space between the first and second members72,74when the implant70is in the compressed state. As such, smaller flanges may allow for additional compression of the portions72,74while larger flanges may “bottom out” or contact one another which may prevent excessive compression. Further, the size of the space76′ can be adjusted to provide sufficient spacing for an insertion guide (e.g. K-wire) in a slot or channel98as shown inFIG. 3. The slot is formed by the proximal and distal ends82,84as a bottom surface and the first and second portions72,74(with a larger height) as side surfaces. The height of the portions72,74allows the insertion guide to be positioned within the slot without extending beyond the perimeter established by the first and second portions. In other words, the slot98is defined by upper surfaces of the proximal and distal ends and inner surfaces of first and second portions72,74as the first and second portions72,74sit higher than proximal and distal ends. Moreover, the slot98allows the insertion guide to extend through the implant along a proximal to distal axis, and for the implant70to be able to travel along the insertion guide, without requiring an enclosed cannulation.

The implant70shown inFIGS. 1-4can optionally include at least one anchoring element, illustrated here in the form of barbs92. In this embodiment, the barbs92on the proximal portion88of the implant70face one direction while the barbs on the distal portion86face another direction. Orienting the barbs92in this way allows the distal portion86to be inserted into a first bone (e.g. middle or intermediate phalanx) and the proximal portion88to be inserted into a second bone (e.g. proximal phalanx), while preventing removal of the implant from either bone. Other barbs are also envisioned.

Implant70, and indeed all embodiments herein, can be constructed of any material desired, such as metals, plastics, resorbable polymers, tissue such as bone, or the like. As to this embodiment, implant70can be constructed out of any material as it is the geometric design of the implant that provides for the spring-like recovery following compression. In other words, the design of implant70is such that the forces required to compress the implant are less than the yield stress of implant70. To this end, the length, height, width and thickness of each portion can be adjusted as desired to obtain the desired spring characteristic, length of implant, width of implant, height of implant, etc.

FIGS. 5-7illustrate another embodiment of a bone implant having some of the features of the implant ofFIGS. 1-4. However, implant170ofFIGS. 5-7includes a distal portion186which extends along a distal axis102and a proximal portion188which extends along a proximal axis104. The proximal axis104is oblique to the distal axis102. The offset axes allow the implant to approximate an anatomical positioning of the first and second bones with respect to each other. This angle may be any angle desired or useful for a particular anatomy.

FIG. 7illustrates a sectional view of the implant100along line A-A ofFIG. 6. The first and second flanges (labeled generally as “78”) can be positioned anywhere desired on the implant100, such as on the distal portion or on the proximal portion. Alternatively, the first flanges178, as illustrated, can be partially positioned on the proximal portion188and partially on the distal portion186. The slot198allows the implant100, as discussed above, to ride along a straight insertion guide as the implant is inserted into bone such that a bent or curved guide is not required, though could be used. For example, the straight insertion guide could travel along the top surface of the proximal and distal ends (as described relative toFIGS. 1-4) and in between the first and second portions (as described relative toFIGS. 1-4). Further, the insertion guide may also contact one or both of the flanges, or alternatively, the flanges may remain separated from one another such that the insertion guide does not contact them (or, such that the insertion guide travels in between the flanges). In still a further alternative, the insertion guide could travel along the implant contacting one or both flanges and one of the proximal or distal ends. In yet a further alternative, the insertion guide could contact all three of the proximal and distal ends and the one or both flanges.

FIGS. 8-10illustrate one embodiment of a tool for use with the implants of the present disclosure. Namely, the tool is an inserter instrument or clip106which is used to transition or maintain the implant, such as implant70ofFIGS. 1-4, in the compressed state. The clip106includes arms108which each have an angled portion110. In use, for example with implant70ofFIGS. 1-4, the engagement surface90of the implant70is positioned between the arms108. The angled portions110can assist in transitioning the implant to the contracted state when the implant is pressed between the arms108. In other words, as the engagement surface90is moved upwards into a position in between the arms108, the taper of angled portions110may gradually compress the first and second portions72,74towards one another from the implant's relaxed state (FIG. 2) to its compressed state (FIG. 4).

FIGS. 11A-11Dshows one embodiment of a tool which may be used to handle and manipulate an implant of the present disclosure. As illustrated, an instrument/inserter handle112can be used to hold the implant, for example, implant70, during an insertion or removal procedure. The handle112includes an opening114to receive either the proximal portion82or distal portion84of the implant70. In addition, opening114can receive an insert, such as insert200shown inFIG. 11C. Insert200may be used to help secure implant70within handle200. In this regard, insert200includes a body202, flexible legs204extending from one end of the body202, and flexible arms206extending from another end of body202. Flexible legs206releasably connect to a post (not shown) within opening114to secure insert200to handle112and so that arms206are positioned adjacent the distal extent of opening114. Flexible arms206are biased inward so as to pinch an implant70therebetween when such implant70is inserted into opening114. The opening114is generally sized to receive the implant in the contracted state. Although the handle112is shown inFIGS. 11A-11Das receiving the straight implant70, the handle can also receive the angled implant100ofFIGS. 5-7, or any other implant described herein. In one exemplary use, the handle112may be used to compress the implant and position the implant onto the insertion guide previous disclosed. In some embodiments of handle114, a cannulation may also extend through the handle112which may receive an insertion guide (e.g. K-wire). Such K-wire may be used in conjunction with implant70, such as through channel98.

FIGS. 12-13illustrate another embodiment of a tool of the present disclosure, the tool being an inserter instrument or clip118with arms120that move between a closed configuration (FIG. 12) and an open configuration (FIG. 13). The clip118is similar to the clip ofFIGS. 8-10in that the clip118is designed to hold the implant during an implantation procedure in the compressed state. The clip118includes a sheath122which is moveable with respect to the arms120. The arms120are in the closed configuration when the sheath122is in the advanced position (FIG. 12). The arms are in the open configuration when the sheath is in the retracted position (FIG. 13). An implant in the relaxed state can be positioned between the arms120in the open configuration. The sheath is then moved to the advanced position to transition the arms to the closed configuration. As the arms move toward each other they contact the engagement surface of the implant to transition the implant to the compressed state.

In yet another embodiment,FIGS. 51A-51Billustrate a tool, inserter instrument or clip318, including an end having arms320,321which together hold an implant within opening325. Arms321may serve as additional width retention to minimize pivoting of the implant within the tool. Arms320include beveled tips323which hold the implant within opening325. Specifically, arms320may have an amount of flexibility such that an implant may be positioned against the bevels of tips323, and upon application of force on the tool318towards the implant, the tapered surfaces of the tips323force the arms320away from one another to allow passage of the implant into the opening325. Once the implant moves past tips323, the arms return to their original position to maintain the implant within opening325. Similarly, upon implantation of the implant, removal of the tool318from the implant can be performed by pulling back on the tool whereby the shape of the tips323flex the arms away from one another such that the implant can slide past the tips.

FIGS. 52A and 52Billustrate another embodiment of a tool418. Tool418is similar to tool318(and as such like reference numbers denote like structures), above, except tool418includes a second end opposite a first end. As such, tool418includes two openings425,425′ defined by arms420,421and420′,421′, respectively. As illustrated, the two ends may be of different sizes to accommodate different sizes of implants. Alternatively, the two openings425,425′ could have different shapes such that a single instrument could be used for insertion of differently shaped implants.

FIGS. 53A-Cillustrates yet another embodiment of a tool518. Tool518includes a base526having a body and arms520extending therefrom, and a collet527positioned on the body. As illustrated, the collet and base can have a threaded relationship but other engagement structures are also envisioned. As illustrated, the threaded collet can be rotated around the base in order to migrate along the length of the threaded body. The collet is intended to affect the distance of the arms520relative to one another. Specifically, the inner surface of the collet is tapered (illustrated as convex) which contacts a tapered surface of the base526on the arms520. As the collet migrates downwards and the tapered surfaces contact one another, the arms are flexed inwards, and conversely, as the collet migrates upwards and the tapered surfaces move away from one another, the arms are allowed to return to their original, spread position. Thus, in use, an implant can be positioned within opening525and the collet can be migrated downwards such that the arms flex inwardly until the implant is contained within the opening525by arms520and tabs523. Once the implant is implanted, and the tool518can be removed, the collet is migrated upwards, away from the arms520, to allow the arms to return outwards to their original position to release the implant. Further, the adjustability of tool518may allow for the same tool to be used with variously sized and/or shaped implants.

The various tools and implants can be utilized to perform a surgical procedure on a patient in need thereof. In one embodiment, implant70may be implanted into two bones, for example, the proximal phalanx and the middle phalanx. While this method will be described using such specific implant, tools and anatomy, it is envisioned that any other implant and tools herein could be used in this method.

Generally speaking, in this method, the implant70is transitioned to its compressed state and inserted into the two bones. Once the implant is properly positioned, the force is removed and the implant returns towards or to its relaxed state, at which point the first and second portions72,74abut the inner surface of the bone. The barbs92, if present, provide additional securement against the bone surface such that the implant, and the two bones, are securely positioned relative one another. The ability of implant70to be compressed at a single location, engagement surface90, leaves both ends82,84of the implant exposed and ready for insertion.

Continuing with this exemplary method of a method of arthrodesis, the phalangeal bones are resected at the ends to be joined (i.e., the ends forming a joint for example, the head of the proximal phalanx and the base of the middle phalanx are both resected). A bore hole is then formed in each bone using a drill, broach, rasp or other such device known in the art.

The implant70, in its compressed state, it brought into the surgical area. As discussed above, the implant can be compressed at a single location on the implant, which compresses both portions86,88. In this embodiment where arthrodesis is performed, the engagement surface90may be designed to be positioned at or near the joint line between the two prepared bones. This positioning may be beneficial as the tool, such as clip106, can remain positioned on the implant until both portions86,88are positioned in the first and second bones.

Continuing with this method, the implant ends82,84are then moved into the first and second bones. While the implantation can be in any order, continuing with the example, the proximal portion88can first be positioned into the proximal phalanx until the prepared end of the proximal phalanx is adjacent to or abutting the tool, and then the distal portion86can be positioned into the middle phalanx until the prepared end of the middle phalanx is adjacent to or abutting the tool. In this position, the tool may then release the implant70and the tool is removed from the surgical area. Release of the implant allows the implant to return towards or to its relaxed state, thereby engaging the first and second bones. Any remaining gap between the bones, where the tool was previously positioned, can be reduced by manual compression of the bones.

Optionally, the above method may include the use of a guide, such as a K-wire and/or handle112. In this embodiment, one end of the K-wire may be positioned in one of the first or second bone, while the implant70is positioned on the length of the K-wire such that the K-wire sits in slot98. If handle112is used, the K-wire would then be positioned through slot98and into cannulation116of handle112. The implant70would then be directed along K-wire and towards the bone, such that the K-wire guides the implant into the formed bore hole. These steps may be repeated for the other of the first and second bones, if desired.

Other tools are also envisioned for use with the implants and methods herein, including other instruments, bands (whether elastic or inelastic), or the like.

Though the implant is intended to remain permanently in the patient, there may be an unplanned and unintended need for removal (e.g., infection, irritation, etc.). The novel structure of the implants herein, such as implant70, allows for ease of removal. For instance, in one embodiment, continuing with the above method for ease of illustration, the first and second bones can be separated slightly (as known in the art) to gain access to the implant. The tool, such as clip106, is then re-engaged to the implant70, preferably at the engagement surface (if exposed). This re-engagement compresses the implant to its compressed state such that the width of the implant is decreased on both portions86,88. The compression of the implant allows for ease of removal of the implant from both the first and second bones.

Also disclosed herein are various other embodiments of implants of the present disclosure. While other implant variations are envisioned, the following embodiments serve as further examples of implants that provide a single location for compression of the implant for insertion into a bone, portions of a bone, or adjacent bones. Similar features in the following embodiments as to the above embodiments of implant70,170have similar functionality and use as detailed above. Further, these various implants of the present disclosure may be used in the exemplary methods provided above.

In one such embodiment,FIGS. 14-18 and 20illustrate implant270which includes a central body271having a first end from which arms272a,274aextend and a second end from which arms272b,274bextend. As illustrated, the arms extend from the respective end of body271in a direction along the length of body271and outward away from the body. Further, arms272a,274aextend away in a similar direction along the length of body271but outward in opposite directions from one another, and similarly, arms272b,274bextend away in a similar direction along the length of body271but outward in opposite directions from one another. In other words, for example, arms272a,274aextend from a distal end of the body271to form a proximal end of implant270, and arms272b,274bextend from a proximal end of the body271to form a distal end of implant270. Each arm extends to a respective end282a,282b,284a,284band one or more of the ends may include at least one barb292thereon. As above, the barbs may be shaped to allow for ease of insertion into a bone but resist the implant from pulling out of the bone.

As particularly illustrated inFIGS. 15-18 and 20, implant270has a relaxed state (FIGS. 15 and 16) and a compressed state (FIGS. 17, 18 and 20) which, similar to as detailed above, includes a bias towards the relaxed state. Rather than the flanges78,80found on implant70, the arms of implant270will simply approach one another or even contact one another in the compressed state. A tool, such as clip218inFIG. 20for example, can be used (or alternatively an operator's hand can be used) to transition the implant270from the relaxed state to the compressed state. Specifically, as inFIG. 20, clip218includes top, bottom and side surfaces221,222,223on arms220such that all four arms272a,274a,272b,274bcan be transitioned to the compressed state simultaneously. Arms272a,274aare illustrated as being positioned on a plane substantially perpendicular to a plane on which arms272b,274bare similarly positioned, though other relative angles of each arm to the others are also envisioned. Similar to implant70, implant270may also include a general engagement surface290on the four arms (as illustrated inFIG. 20) adjacent one another such that the clip218can engage the implant270at a single location along its length and compress all four arms. As such, implant270can be used in the method detailed above relative to implant70.

As with the embodiments above, the thicknesses, lengths, materials, etc. of the implant can be designed as desired to provide the desired spring characteristic, length of implant, width of implant, height of implant, etc. Further, since implant270include individual arms, each independent arm relative to the others, may be designed differently as desired to provide the desired spring characteristic, length of arm, etc. of each individual arm.

Further, implant270can include slot298to allow passage of a guide, such as a K-wire, therethrough. Further each arm can include a concave surface299a,299b,299c,299dits the inner surface to allow passage of the K-wire when the arms are in the compressed position (seeFIG. 18).

In another embodiment,FIG. 19illustrates an implant370having some of the features of the implant ofFIGS. 14-18 and 20. However, implant370ofFIG. 19(similar to implant170ofFIGS. 5-7) includes a distal portion386which extends along a distal axis302and a proximal portion388which extends along a proximal axis304. The proximal axis304is oblique to the distal axis302to approximate an anatomical positioning of first and second bones. This angle may be any angle desired or useful for a particular anatomy. As illustrated, the angle is formed along the length of arms372b(behind arm374b),374b, and potentially through body371(behind arm374b) though the location of the angle may be formed elsewhere along the length of the implant370as desired.

In another embodiment, illustrated inFIGS. 21-27, implant470has a first portion472and a second portion474connected to each other at a proximal end482and a distal end484. Each of the first portion and second portion includes end sections472′,472″,474′,474″, and a middle section which, as illustrated, forces an engagement surface490. End section472′ curves away from end section474′ from proximal end482, and end section472″ curves away from474″ from distal end484. Similarly, the respective end sections curve back towards one another, and past each other, towards engagement surface490. These curves along first and second portions472,474form two spaces476and a third space477. However, in an alternative embodiment, the first and second portions might not cross past one another, and thus third space477may not be present as illustrated. Additionally, at least one part of the implant can include at least one barb492. Either way, as shown inFIG. 24, the first and second portions are offset laterally relative to one another to provide an allowance for the movement of and/or interaction with engagement surfaces490.

Similar to the other embodiments above, implant470includes a relaxed state, as inFIGS. 21-25A, and a compressed state, as inFIGS. 25B and 26. As such, a tool, such as clip418inFIG. 26, can be positioned at a single location along the length of the implant, i.e., engagement surface490, and used to transition the implant to the compressed state. As shown, clip418includes arms420that can be positioned on the engagement surfaces490, within space476, and separated from one another to move engagement surfaces490away from one another. In turn, as inFIGS. 25A and 25B, as engagement surfaces490separate, end sections472′,472″ and474′,474″ move towards one another to compress the width of portions486,488of the implant.

In this embodiment, as illustrated inFIG. 27, transitioning the implant from the relaxed state to the compressed state also may cause the implant to increase in length. Such elongation of implant470provides for a compression action on the bone portions in which it is implanted (one method of which is discussed in detail above). In other words, with the implant positioned in the bones in the compressed state, release of the tool allows the implant to return to the relaxed state. As this transition occurs, the implant engages the bones and pulls the bones towards one another as the length of the implant decreases. Thus, the aforementioned manual reduction of the bones may not be necessary in this example.

In another embodiment, the implant470could be angled (not shown), in similar fashion to implants170,370discussed above.

In still another embodiment, illustrated inFIGS. 28-34, implant570includes four arms572a,572b,574a,574bthat are sequentially connected to one another such that arm572aconnects with arm572bat distal end584a; arm572aconnects with arm574aat proximal end582a; arm574aconnects with arm574bat distal end584b; and arm574bconnects with arm572bat proximal end582b. As in implant270, discussed above, proximal ends582a,582bare spaced apart from one another in a relaxed state and distal ends584a,584bare spaced apart from one another in the relaxed state, as illustrated inFIGS. 28-31. One or more of the proximal and/or distal ends can include at least one barb292thereon.

FIGS. 32-34illustrate a compressed state of implant570in which proximal ends582a,582bare brought towards one another, and may contact one another, and distal ends584a,584bare brought towards one another, and may contact one another. Alternatively, while the proximal and distal ends are illustrated as being generally parallel to one another at each end (i.e., end582arelative to end582b), and the opposing ends as being generally perpendicular to one another (i.e., end582arelative to end584a), these angles and relationships may be varied as desired.

As in the other embodiments, transition of the implant from the relaxed state to the compressed state can occur by application of a force to a single location along the length of the implant. As illustrated, a tool (not shown) can contact engagement surface590, on at least one of the arms, and preferably on all four arms572a,572b,574a,574b, to apply such force to draw the arms towards one another. Again, similar to implant270, slot598constricts to slot598′ upon transition to the compressed state, and arms include concave surfaces599a,599b,599c,599dto allow for passage of a guide, such as a K-wire, through the slot which may assist in insertion of the implant into the bone or bones.

In another embodiment,FIGS. 35A and 35Billustrate implant670having some of the features of the implant ofFIGS. 28-34. However, implant670, similar to implants170,370above, includes a distal portion686and a proximal portion688that extend along axes that are transverse to one another. While the angle or bend in the implant may be positioned adjacent to or at engaging surface690, it may be positioned anywhere desired.

In a further embodiment,FIG. 44provides a sketch of implant970having some of the features of the implant ofFIGS. 1-4. However, while implant970includes a monolithic construction, and generally includes the same features and shapes as implant70,170, first portion972and second portion974are only continuous with one another at the proximal end982and are spaced from one another at the distal end984.

In another embodiment,FIG. 45provides a sketch of implant970′ which is largely similar to implant970, except that the first portion972′ and second portion974′ are only continuous with one another at the distal end984′ and are spaced from one another at the proximal end982′.

As with other implants discussed above, upon compression of either implant970or implant970′, the ends spaced from one another move towards one another to create a smaller cross-section which may be suitable for insertion of the implant into bone, as discussed above.

In yet another embodiment,FIG. 46provides a sketch of implant970″ which is largely similar to implant970′, and as such the first portion972″ and second portion974″ are only continuous with one another at the distal end984″ and are spaced from one another at the proximal end982″. However, ends973″,975″ of the first and second portions of implant970″ interact with one another. For instance, as illustrated, end973″ tucks within end975″. The ends in this configuration may have corresponding shapes to promote nestling of end973″ against end975″ (e.g., matching concave and convex surfaces). Such interaction of the ends may help maintain alignment of the portions972″,974″ during compression by lessening the chance that the end move laterally relative one another and slide past one another. Further, if for example, end975″ extends fully around end973″, the extension of end975″ may prevent end973″ from bending outwards when compression is applied on the midsection of the implant.

WhileFIGS. 44-46are sketches, it should be understood that each of these implant embodiments are generally flat in shape and may also include additional structures such as barbs92, flanges78,80and other such structures illustrated with respect to implant70,170. Further, each of these implants970,970′,970″ can be manipulated, handled and implanted as discussed above relative to implant70,170. Still further, each of these implants can include an angle as discussed above relative toFIGS. 5-7.

Further,FIGS. 44-46may be constructed of metal, such as titanium, Nitinol, stainless steel, or the like. The open end may reduce the overall strength of the implant such that the metal structure can be more easily flexed/compressed for insertion into bone.

In another embodiment, as illustrated inFIG. 47, implant1070includes a first portion1072and a second portion1074connected at a proximal end1082and at an intermediate location1086. The first and second portions also include ends1073,1075, respectively, which extend from the intermediate location to a distal end1084. The ends1073,1075, can also include flanges1078,1080, respectively,

Implant1070may be compressed at two separate locations on either side of the intermediate location1086, typically prior to insertion of each end into a bone. For instance, the proximal side with opening1076can be compressed for insertion of the proximal side into bone, and the distal ends1073,1075can be compressed for insertion of the distal side into bone. The flanges1078,1080may limit compression of ends1073,1075as discussed above relative to implant70.

In still another embodiment,FIG. 48illustrates implant1170having a first portion1172and a second portion1174connected at a proximal end1182and a distal end1184in similar fashion as implant70discussed above. Implant1170further includes a bullet nosed distal end1184which includes additional material versus implant70. Such additional material can be beneficial where implant1170is formed of plastic, such as PEEK, which has ample flexibility. The added material in distal end1184, which is smaller in size than the proximal end1182, increases strength of the distal end1184and may limit some flexibility of the distal portion of the implant which may improve fixation of the implant in the bone. Implant1170also can include a flange or flanges1178,1180extending into opening1176, similar to the flange(s) and opening in implant70. Optionally, implant1170(and indeed, any of the embodiments discussed herein) can include a cannulation suitable for passage of the implant onto a guidewire.

In another embodiment,FIG. 49illustrates implant1270which is similar to implant1170(and like reference numbers denote like structures), above, in that it includes a bullet-shaped distal end1284, though distal end1284has a narrower shape than distal end1184of implant1170. Also illustrated is the optional cannulation1298for passage of the implant over a guidewire. During insertion, an operator would compress first and second portions1272,1274along opening1276for insertion of the proximal end1282into bone, while distal end1284may simply be press-fit into bone.

In yet another embodiment,FIG. 50illustrates implant1270′ which is similar to implants1170,1270(and like reference numbers denote like structures), but instead of a bullet-shaped distal end1184,1284, the distal end1284′ is rounded and includes a second opening1277′ therein. Contrary to implant1270, above, distal end1284′ in this instance may also be compressed by the operator for insertion into bone, though a simple press-fit technique may still be suitable.

The various implants illustrated inFIGS. 47-50may be formed of plastic, such as PEEK. PEEK has greater flexibility than, for example, metal (e.g., as used in the implants ofFIGS. 44-46), and thus the addition of material to the structure may help to increase strength and decrease some of the flexibility such that the anchor can still be flexed or compressed for insertion into bone, but also have the strength to maintain its position in bone.

WhileFIGS. 47-50are sketches, it should be understood that each of these implant embodiments are generally flat in shape and may also include additional structures such as barbs92, flanges78,80and other such structures illustrated with respect to implant70,170. Further, each of these implants1070,1170,1270,1270′ can be manipulated, handled and implanted as discussed above relative to implant70,170. Still further, each of these implants can include an angle as discussed above relative toFIGS. 5-7.

In still another embodiment, the implant of the present disclosure can be constructed of allograft. For instance, as illustrated inFIGS. 36-39, implant770includes a first side surface772and a second side surface774and a top surface775and bottom surface776, though it is noted that the final positioning in bone does not require any particular orientation. At least one of the surfaces can include at least one barb792, and as an example, as illustrated, barbs are only on side surfaces772,774.

Implant770may be constructed of any material desired, and preferably the implant body is constructed of allograft. While implant770does not have a spring-like structure, like the other embodiments disclosed herein, the allograft substance itself can be designed to have a degree of compressibility. For instance, including a higher amount of cancellous bone and less cortical bone could allow for increased compressibility, while a higher amount of cortical bone can be used to create a harder implant that can better maintain a specific orientation of the bones relative to one another. The allograft may also optionally be demineralized in a portion or throughout the implant body to provide further compressibility. In this instance, the implant would be partially demineralized such that the implant has a degree of compressibility while still maintaining strength. Further, various surface features, such as barbs and the like, or throughbores or other structures may be manufactured into the implant as desired to generate beneficial effects such as increased resistance to pullout, increased bone ingrowth, and the like.

While compression of the implant770may not be necessary for insertion, the implant can still include an engagement surface790along the length of the implant for interaction with a tool for insertion or removal.

Implant770, as illustrated, includes a bend or angle, similar to implants170,370,670above, such that a proximal portion788extends along a first axis and a distal portion786extends along a second axis transverse to the first axis. However, as with the other embodiments herein, implant770may also be linear.

Since the ends of the implant770do not require compression, the method of insertion may include, in one embodiment, preparing the first and second bones as discussed above. With the bones prepared, the implant is then inserted into one of the bones first and then into the second bone. Each time, the implant is pressed into the bone until the bone is adjacent to or contacts the insertion tool at engagement surface790. Generally, the allograft of implant770has a degree of compressibility such that implant770is inserted into the bones by press-fit. For instance, the implant is pressed into each bone via a force applied to the inserter such that the ribs (if present) deflect as they pass into the bone. Once the implant is in position, the ribs, or the body of the implant itself, serve to inhibit removal of the implant from the bone. The inserter is then removed from the implant and any space between the bones is reduced by manual compression.

In yet a further embodiment, an implant of the present disclosure can be constructed of a porous material, such as a porous metal. For instance,FIGS. 40A-Band41illustrate another embodiment of an implant870including a body875that is at least partially constructed of a porous material, such as a porous metal structure. As illustrated, the body875can be completely formed of porous material.

FIG. 42illustrates an alternative implant870′ which includes a porous portion877′ and a nonporous portion876′, illustrated as a nonporous spine or core, though the nonporous and porous portions can have any configuration in the longitudinal and/or latitudinal directions. Further, the implant could include multiple nonporous portions present within the body of the implant. These nonporous portion or portions might provide additional support to the implant structure.

As with implant770, the porous or partially porous body875of implant870can promote bone ingrowth and integration into the implant. The degree of porosity and amount of the body forming the porous portion can all be varied to provide for the desired amount and location of bone ingrowth. Further, the porous portions of the implant may provide a spring-like structure to the implant, as discussed above relative to implant770.

The porous portion can be constructed as is known in the art, for example through negative manufacturing techniques such as laser etching, or additive manufacturing techniques such as powder metallurgy, stereolithography, 3-D printing, selective laser melting (SLM), additive layer manufacturing (ALM), tessellation, other pore forming or metallic foam manufacturing techniques, or the like. Examples of additive manufacturing techniques which can be used in forming such a porous portion include U.S. Pat. Nos. 9,403,213; 7,537,664; 8,992,703; 8,728,387; 9,135,374; 7,674,426; 9,089,431; 9,089,427; and 9,180,010; U.S. Published App. No. 2006/0147332; and U.S. application Ser. No. 14/969,695—all of which are incorporated by reference herein as if fully set forth herein. Further, any metal or polymer may be utilized in forming the implant such as commonly used titanium, stainless steel, PEEK, resorbable polymers, and the like.

The shape of implant870can be any shape desired.FIGS. 40-42illustrate rectangular cuboid shapes, whileFIG. 43illustrates a unique shape that includes a threaded portion888and a portion889extending into multiple arms. Other shapes are also envisioned. Additionally, the rectangular cuboid implant870can also optionally include a bend or angle, as inFIG. 40B, and as discussed in other embodiments above. Still further, as illustrated for example inFIG. 43, the implant870″ could include at least one barb and/or thread, or other such structure, to improve fixation with the surrounding bone.

Implant870may be implanted in similar fashion as implant770, described above, that is, via press-fit.FIGS. 40A-Billustrate an example of the implant870being positioned in first and second bones B1, B2.

FIG. 54depicts a bone implant670according to another embodiment of the present disclosure. Implant670is similar to implant70in that it includes first and second portions672,674separated by a gap and proximal and distal ends682,684connecting said first and second portions672,674. However, implant670differs from implant70in that implant670is constructed from a polymer material such as PEEK, for example. As discussed above with regard to implant1170, such a polymer implant may have more material at one of its ends to provide additional rigidity. In this regard, while implant670includes a substantially uniform wall thickness at its proximal end682, the distal end684includes a web681that extends in a proximal-distal direction. Such webbing684also helps provide strength to implant670as it is press-fit into a bone.

FIG. 55Adepicts an implant loading device or implant loading puck700according to an embodiment of the present disclosure. Loading device700may be used to help load implant70, or other implants disclosed herein, onto clip106. In this regard, loading device includes a body with a first recess702that has a general shape of implant70. Thus, first recess702can be angled to conform to straight implant70or angled implant170(discussed above). A second recess704intersects first recess702and is shaped to receive arms108at a distal end of clip106. Moreover, second recess704intersects first recess702at a predetermined location such that when implant70is disposed in first recess702, second recess704aligns with engagement surface90. In this regard, inserting the distal end of clip106into second recess704guides clip106into engagement with implant70at the desired location.

Loading device700also includes a removable lid710that helps prevent implant70from being inadvertently removed from first recess702. As shown, lid710is configured to slide within slots (not shown) at opposite sides of first recess702so as to selectively cover first recess702. In addition, lid710can be positioned so that it covers a portion of implant70disposed within first recess702while not obstructing second recess704so that implant70can be engaged with clip106. Once implant70is secured to clip106, lid710can be slidably removed from device700thereby uncovering first recess702and allowing implant70to be removed. Although a sliding lid is shown, other selectively removable retaining configurations are also contemplated, such as lid that snaps onto device with a snap-fit feature, a cover having an adhesive surface, or the like as is commonly understood in the art.

In other embodiments, a kit can be formed from one or more implants and instruments. One such example is a kit800depicted inFIG. 55B. As shown, kit800includes an inner shell802, inserter handle112, clip106, loading device700, implant70within device700, and cutting tools812,814(e.g., drill bits). Inner shell or blister802may also include an inner shell cover (not shown). Inner shell802and inner shell cover may be provided in an outer shell/blister (not shown) with a peelable membrane. Inner shell802includes various compartments for sterilization and transport of each component mentioned above. In addition, loading device700may be preloaded with implant70, or another one of the implants described herein. Alternatively, one or more bone implants can be provided in a separate compartment and may be loaded into loading device700within the operating theater.

In a further kit embodiment, a kit may include at least one combination of an implant secured to a tool, such as clip106, for use in insertion of the implant. The combination of implant secured to the tool can be packaged in this fashion. Alternatively, the package could include at least one implant and at least one tool therein for subsequent connection.

In another kit embodiment, a kit could include a container with individually packaged implants and at least one individually packaged tool. The tool could be universal to all implants or separate tools could be available for use with certain implants in the container. In another variation, such a kit could include a first container with at least one implant (packaged individually or as a group), and a second container with at least one tool (packaged individually or as a group). Further, either of the containers could include other instruments, such as one or more of a drill, a guide (such as a K-wire), a bone shaver or cutter, and the like.

Other combinations of kits, including those including more than one implant of a particular embodiment above, or those including various embodiments of the implants above, are also envisioned. For example, a kit can include at least one implant70and multiple implants170having various angles such that an operator can select a particular angle of implant for use in a particular procedure. Any of the above kits may further include a surgical procedure which may include instructions or protocol for selecting and using the elements of the particular kit.

FIGS. 56A-56Bdepict a method of implantation using the components of kit800. In the method, after all components106,112,700, and810are removed from the kit container, drills812,814are used to form openings in respective proximal and distal bone fragments B1, B2. In addition, bone implant70is connected to clip106. In this regard, lid710may be slid rearward to expose second recess704or, in some embodiments, lid710may already be positioned so as to not cover second recess704while still covering a portion of first recess702. Clip106is then inserted into second recess704as shown inFIG. 56Asuch that arms108of clip106engage respective first and second portions72,74of bone implant70at the engagement surface90thereof. As clip106is advanced into the second recess704, angled portions110of arms108push first and second portions72,74toward each other so as to position first and second portions72,74into a compressed state. The bias of the first and second portions72,74against arms108of clip106help secure bone implant70to clip106. During engagement of clip106to bone implant70, lid710helps prevent the distal end84of bone implant70from popping out of first recess702.

Once bone implant70is secured to clip106, lid710is removed from loading device700and clip106is lifted out of loading device700along with bone implant70, as best shown inFIG. 56B. Thereafter, proximal end82of bone implant70is loaded into the distal end of inserter handle112, as shown inFIG. 56C. In this regard, proximal end82of implant70is inserted into opening114and between arms of insert200until implant70abuts an abutment surface208of body202. As this occurs, arms206flex outward and pinch implant70therebetween to securely hold implant700. Clip106remains attached to implant70and is positioned adjacent distal end of handle112, as best shown inFIG. 11D.

Once implant70is secured to distal end of inserter handle112, implant70can be inserted into bone B1. In this regard, inserter handle112is manipulated so as to insert distal end84of implant70into proximal bone B1, which may be performed in a press-fit manner. Thereafter, handle112is detached from implant70by pulling handle112in an opposite direction. At this point, the distal end of clip106is positioned adjacent bone B1, as shown inFIG. 56D. Proximal end82of implant70is then placed into distal bone B2, as shown inFIG. 56E. At this point, clip106which has a narrow thickness, is positioned between bones B1and B2. The clip106is then removed, which allows first and second portions72,74to move toward their uncompressed state. As this occurs, first and second portions72,74push firmly against bones B1and B2causing barbs92to bite into the bone to prevent removal therefrom. However, due to the angle of the barbs92, bone B2can be pushed against bone B1and moved relative to implant70to close the space left by clip106.

To summarize the foregoing description, a bone implant may include a proximal end; a distal end; a first portion extending between the proximal and distal ends having a maximum portion height and a minimum portion height; a second portion extending between the proximal and distal ends having a maximum portion height and a minimum portion height, the second portion connected to the first portion at the proximal end and the distal end and the second portion moveable with respect to the first portion to transition the bone implant between a relaxed state wherein the first and second portions are separated by a first distance and a contracted state wherein the first and second portions are separated by a second distance different from the first distance; and at least one of the proximal end and the distal end having the minimum portion height; and/or

the bone implant may also include an anchor element on at least one of the first portion and the second portion; and/or

the bone implant can be transitioned to or maintained in the contracted state via engagement with an instrument at a single contact point on each of the first portion and the second portion; and/or

the proximal end is oblique to the distal end; and/or

the bone implant may include a first flange extending from the first portion towards the second portion and a second flange extending from the second portion towards the first portion; and/or

the first and second flange members are spaced from one another when in the relaxed state and contact one another when in the contracted state; and/or

a proximal end width is greater than a distal end width; and/or the first and second portions define a channel extending between the first and second portions and towards the proximal and distal ends, the channel adapted to accept a guide wire therein.

Also described is a bone implant system which may include: a monolithic bone implant including a proximal end, a distal end, a first portion extending between the proximal and distal ends, a second portion extending between the proximal and distal ends, and a channel extending between the first and second portions and towards the proximal and distal ends; and a guide wire adapted to be positioned along the channel, wherein, with the guide wire positioned along the channel, the bone implant is adapted to travel along the guide wire to an implantation site.

Also described is a method of implanting a bone implant, which may include: obtaining a monolithic bone implant including a first portion connected to a second portion at a proximal end and a distal end; engaging the implant with an instrument at a single point of contact on each of the first and second members to transition the bone implant from a relaxed state where the first portion is separated from the second portion by a distance to a contracted state where the first portion is separated from the second portion by a reduced distance; with the bone implant in the contracted state, inserting the proximal end of the bone implant into a first bone portion; with the bone implant in the contracted state, inserting the distal end of the bone implant into a second bone portion; and disengaging the insertion instrument from the bone implant to allow the bone implant to return to the relaxed state; and/or

the bone implant includes a channel extending between the first and second portions and towards the proximal and distal ends, wherein, prior to the step of inserting the proximal end of the bone implant into the first bone portion, the method further comprises the step of implanting a guide wire into the first bone portion, and the step of inserting the proximal end further comprises positioning the guidewire through the channel and moving the bone implant along the guidewire and into the first bone portion; and/or

with the guidewire positioned through the channel, the guidewire contacts at least two of the proximal end, the distal end, and first and second flanges, the first flange extending from the first portion towards the second portion and the second flange extending from the second portion towards the first portion; and/or

the method may include the steps of: reengaging the implant with the instrument; transitioning the implant from the relaxed state to the contracted state; and removing at least one of the proximal and distal ends of the implant from the bone; and/or

the inserting the proximal end step includes inserting the proximal end into a proximal phalanx and the inserting the distal end step includes inserting the distal end into a middle phalanx; and/or

the first portion includes a first flange and the second portion includes a second flange and the engaging step includes transitioning the bone implant to the contracted state such that the first flange is adjacent the second flange; and/or

the method may include the step of positioning at least a portion of the first flange and second flange between the first bone portion and the second bone portion; and/or

the bone implant includes a proximal end portion and a distal end portion, the distal portion oblique to the proximal portion, and the step of inserting the distal end includes orienting the second bone oblique to the first bone; and/or

the bone implant includes a proximal end portion and a distal end portion and the method further comprises simultaneously transitioning the proximal end portion and the distal end portion to the contracted state by engaging the bone implant with the insertion instrument.

Also described is a bone implant, which may include: a proximal end; a distal end; a first portion; a second portion connected to the first portion at the proximal and distal ends of the bone implant; a first flange extending from the first portion towards the second portion; and a second flange extending from the second portion towards the first portion, wherein the implant can be transitioned between a relaxed state where the first flange and second flange are separated by a first distance and a contracted state wherein the first flange and the second flange are separated by a second distance different from the first distance; and/or

the first and second portions have a portion height and the first and second flanges have a flange height smaller than the portion height; and/or

the implant may include a channel defined between the first and second portions, the channel having a height defined by the difference between the portion height and the flange height; and/or

the first and second portions include a portion height and at least one of the proximal and distal ends of the bone implant have an end height smaller than the portion height; and/or

the implant may include a channel defined between the first and second portions and within the portion height, and the channel ending above the end height at the proximal and/or distal end; and/or

the implant may include a first anchor on the first portion to prevent movement of the bone implant in a first direction; and a second anchor on the first portion to prevent movement of the bone implant in a second direction; and/or

the implant includes a proximal end portion extending along a proximal axis and a distal end portion extending along a distal axis transverse to the proximal axis.