JP7068234B2 - Bone implants and means of insertion - Google Patents

Description

The present invention relates to the field of medical devices. More specifically, the present invention relates to the art of bone fixation or joint fixation or deformity correction. The present invention relates to a fixation system for all types of bone using an assembly composed of inserters and implants. Such a system is used in osteosynthesis (bone fusion), where the implant bridges the fracture, resulting in compression (or distraction) across the bone element. Compression (or extension) results from the properties of the implant and the various configurations of the implant. For example, the implant can have a first configuration in the free state and a second configuration that requires insertion. Optimal implant placement and function should be able to pre-assemble or attach the implant to the inserter so as to facilitate the placement of the implant on or within the bone. Implants are needed for various bones throughout the skeleton. A "bone fixation device" or implant is a variety of devices that attach objects to bone, including but not limited to staples, bone plates, modular staples, bone screws, pins, blades, suture anchors, etc. Can include any of.

The present invention seeks to solve problems in the prior art. The present invention provides a system that allows an implant to be placed in its final required position with or without additional manipulation. In addition, the invention allows the implant to remain in the first configuration and to take at least the second configuration when the implant is placed in its final position. The present invention does not require an additional implant alignment operation once the inserter has been removed or operated after it has been inserted. The invention can also incorporate other required features into the inserter and implant required for final placement. For example, the inserter can allow the preparation of drill holes, bone screws, etc., or can act to align the implant at a particular location or location.

The present invention includes fastening devices or implants, and means of insertion and / or manipulation. The fastening device can be a bone staple, a bone plate, or a module staple, or the like. The fastening device has elastic properties or other material properties that allow the device to have or be configurable for various positions placed with respect to the bone. The free or embedded state of the device can result in compression and / or elongation over two or more bone elements. The inserter can hold the fastening device (or implant) in a different configuration than the free or embedded configuration. This first configuration may be useful for implant placement on or within the bone element. Fastening devices and implants are used interchangeably in this application and are not intended to be inherently limiting. Also, the means of insertion or manipulation may be referred to herein as an inserter and / or a delivery instrument.

The present invention can have inserters that are pre-attached to or attached to the implant during use. The inserter can be temporarily attached to the implant to facilitate final implantation of the implant device. The inserter has features that engage the implant and can facilitate the inserter to maintain the first implant configuration. Similarly, the implant can have features for engaging the inserter. The inserter is attached or engaged to the implant so that the inserter can be removed when the implant is in its final position on or within the bone. Once the inserter is removed, no additional operation may be required to align the implant to its final placement. Alternatively, the implant may be engineered to achieve final orientation (eg compression). The inserter preferably engages the implant so that it does not interfere with the final implant placement.

The present invention comprises an implant or a portion of an implant made of an elastic material or a material that allows the implant to have multiple configurations. The ability of the implant to have multiple configurations may be the result of material properties with shape memory or hyperelastic properties, or it may be the (mechanical,) of the implant to obtain a second configuration. It may be the result of a physical, chemical, or other form of manipulation. Implants can be held in one configuration during insertion or removal and returned or placed in another configuration in the free or implanted state. Implants can have features for engaging with bone. These features may include bone screws, leg members, or other features for attaching the implant to the bone. The implant may have features for engaging the inserter. The engagement between the implant and the inserter can allow the implant to be placed in its final position without the inserter interfering with this final position. The implant is placed in its final position while the inserter is still engaged with the implant, thus eliminating the need for final / secondary seating. The inserter is preferably removed from the implant in a direction or manner that contributes to the surgical procedure. For example, this removal may be from the top, from the sides, or in any other direction or movement. When the inserter is removed, the implant can be in a free or embedded state configuration. The inserter and / or the engagement feature of the implant may be used to remove or modify the implant, as appropriate. The inserter can be re-engaged with the implant while the implant is in its implanted position. The inserter device usually engages the implant so that it keeps the implant in the first configuration. The implant can have at least a second configuration after the inserter has been removed, the second configuration being different from the first configuration due to material properties or deformation to the final shape. The inserter can have one or more features such as guide means that allow the use of drills, screws, drivers, depth gauges, etc. while the inserter is still attached to the implant. The inserter can have one or more features that allow the bone to be prepared for the implant while the inserter is attached to the implant. The inserter can have features and / or mechanisms that allow the implant to be manipulated to achieve at least the second configuration. The inserter can also have members or features that engage some aspects of the implant to maintain the first configuration. These members may be fixed, non-fixed, or movable (retractable, etc.). The inserter is preferably attached to the implant so that it does not interfere with the final placement or seating of the implant. For example, the inserter need not be attached so that it interferes with the final alignment or placement of the implant on or within the bone. For example, the inserter may be "top loaded" or may be removable away from the bone. The inserter can allow a change in the relative position of one or more legs to, for example, a fastening member or a bridge member (s) to achieve the desired effect, such as compression. This relative position change will not interfere with the final seating of the bridge member or leg on or into the bone.

The inserter may have a one-piece structure, a two-piece structure, or the like, or may be an assembly. The structure can be separated into multiple pieces to facilitate attachment to or removal from the implant. The implant and inserter may be assembled to each other by the manufacturer or may be assembled at the time of use.

The implant has multiple configurations, such as a configuration for insertion into bone and at least a second configuration for compressing, stretching, or controlling spatial orientation of one or more bone segments. And can have. The implant can have one or more bridge members. The implant can have a leg member to engage with the bone. Implants can have modular members for engaging with bone, such as bone screws, pins, or pegs. It will be apparent to those skilled in the art that there are multiple options for connecting implants to bone. The members or features to be connected do not necessarily have to be made of the same material as the bridge component. Deformable embodiments of the invention can be in bridge members, connecting members, or other members of implants or fixation devices. The material properties of the present invention may be appropriate to allow operations other than shape memory of the implant feature to result in the desired result or final configuration of the implant. The leg member may be configured to receive the member from the inserter in order to hold the implant in the first configuration or to allow operations to make the implant another configuration. The first configuration can hold the implant to facilitate final seating of the implant in its final position on the bone. The inserter / implant assembly is preferably such that the inserter feature does not interfere between the implant and the bone. Removal of the inserter can allow the implant to take a second or third or additional configuration. Alternatively, an inserter may be used to manipulate the implant into a second or third or additional configuration.

The above overview of the invention discusses the advantages of the invention with respect to implantable devices. The advantages of the invention can also be applied to embodiments of the invention in external or non-embeddable embodiments. The use of the present invention is not limited to implantable embodiments.

FIG. 3 is a perspective view of a first embodiment of the invention showing a multi-component inserter attached to a modular implant or fixation device. It is a front view of the 1st Embodiment shown in FIG. 1A. It is a top view of the 1st Embodiment which shows the cross-sectional line AA. It is sectional drawing of AA shown in FIG. 1C. FIG. 5 is a cross-sectional view taken along the line AA in which a bone screw is inserted as a means for fixing the implant to the bone. FIG. 3 is a perspective view of a first embodiment of the invention showing a multi-component inserter attached to a modular implant or fixation device. It is a front view of the 1st Embodiment shown in FIG. 2A. FIG. 2B is a top view of FIG. 2B showing a cross-sectional line BB. It is sectional drawing of BB shown in FIG. 2C. It is a perspective view of the implant of the 1st Embodiment in the 2nd configuration with which the bone screw is assembled. It is a perspective view of the first embodiment of FIG. 1 on the bone. FIG. 3 is a perspective view of the first embodiment of FIG. 1 on bone showing the preparation of bone by a drill bit. FIG. 3 is a perspective view of the first embodiment of FIG. 1 on bone showing the preparation of bone by a drill bit. FIG. 3 is a perspective view of the first embodiment of FIG. 1 on bone after the final placement of the implant is complete. FIG. 3 is a perspective view of the first embodiment of FIG. 1 on bone after the final placement of the implant is complete. FIG. 3 is a perspective view of the implant of the first embodiment of FIG. 1 on bone after the final placement of the implant is complete. It is a perspective view of the first embodiment of FIG. 1 not shown on the bone showing the use of a drill. It is a perspective view of the 1st Embodiment which shows the drill abutting with a drill guide. It is a front view of the first embodiment of FIG. 1 not shown on the bone showing a drill abutted by a drill guide. FIG. 3 is a perspective view of a second embodiment of an implant or fixation device shown in the first configuration with parallel leg members. FIG. 11 is a perspective view of a second implant embodiment of FIG. 11 shown in a second configuration in which the legs are converged. It is a perspective view of the 2nd Embodiment of an inserter. FIG. 13 is a perspective view of a second embodiment of the implant or fixation device shown in the first configuration with parallel leg members in the inserter of FIG. FIG. 3 is a front view of a third embodiment of an implant or fixation device in a first configuration. FIG. 15A is a front view of the third implant embodiment of FIG. 15A in the second configuration. FIG. 15A is a perspective view of the third implant embodiment of FIG. 15A. FIG. 15B is a perspective view of the third implant embodiment of FIG. 15B. It is a front view of the third embodiment of the implant assembled in the third embodiment of an inserter. FIG. 3 is a front view of a third embodiment of the implant at the end of engagement with the third embodiment of the inserter. It is a front view of the third embodiment of the implant separated from the third embodiment of the inserter. It is a perspective view of FIG. 17A. It is a perspective view of FIG. 17B. It is a perspective view of FIG. 17C. FIG. 6 is a perspective view of a fourth embodiment of the present invention showing an implant pre-assembled into an inserter having a retractable engaging pin. FIG. 19 is an enlarged view of an action tip portion of the fourth embodiment shown in FIG. FIG. 5 is a perspective view of a fifth embodiment of an implant in an alternative configuration in which the legs or fixation members are out of plane with each other. Another perspective view of the implant of FIG. 21 shows an alternative configuration in which the legs or fixation members are out of plane with each other. It is a front view of the implant of the sixth embodiment assembled to the implant carrier (implant carrier). FIG. 23A is a side view of the implant and implant carrier of FIG. 23A. FIG. 23B is an isometric view of the sixth embodiment of the implant and implant carrier assembly shown in FIGS. 23A and 23B. FIG. 24 is a front view of the implant carrier of the sixth embodiment shown in FIG. 24 without an implant attached thereto. FIG. 3 is an isometric view showing the inserter and the implant / carrier assembly of the sixth embodiment before mounting the carrier on the inserter. Further is an isometric view of the sixth embodiment shown in FIG. 26A, showing the implant / carrier assembled to the inserter. FIG. 6 is an isometric view showing a sixth embodiment of FIG. 26 prior to releasing the implant from the inserter and carrier. 6 is an isometric view showing a sixth embodiment of FIG. 26 after the implant has been released from the carrier, further showing the implant released from the carrier and the carrier still engaged with the inserter. A sixth implementation, further indicating that the implant assembled to the inserter through the carrier is fully seated on the bone and that the inserter and carrier do not interfere with the placement of the implant in its final position. It is a figure which shows the morphology. FIG. 6 is an enlarged view of the implant / inserter interface of the seventh embodiment, showing the implant assembled to the inserter and further showing that the inserter engages the periphery of the implant so that it does not interfere with the final seating of the implant. FIG. 5 shows a seventh embodiment of FIG. 29 showing that the inserter is released from the implant by rotating the inserter to remove it from the implant. It is a figure which shows the 8th Embodiment of this invention that the engaging member for temporary fixation to a bone surface extends through the implant. It is a bottom view of the implant of the 9th Embodiment of this invention which shows the implant which has the means for connecting to the bone engagement feature part and the means for engaging with an inserter. It is a bottom perspective view of the embodiment shown in FIG. 32. 9 is a perspective view of a ninth embodiment showing the implant shown in FIG. 32 assembled to the inserter of the present invention, wherein the implant is held in the first configuration. 9 is a perspective view of a ninth embodiment showing the implant shown in FIG. 32 assembled to the inserter of the present invention, wherein the implant is shown in the second configuration. FIG. 34 is a bottom perspective view of the implant-insertor assembly shown in FIG. 34. FIG. 34 is a cross-sectional view of the implant-insertor assembly shown in FIG. 34. FIG. 6 shows alternative geometry for various means of insertion. It is a top view of the implant of the tenth embodiment of the present invention showing a "T" -shaped implant having a means for connecting to a bone engagement feature and various means for engaging with an inserter. .. It is a perspective view of the implant of the tenth embodiment of this invention. FIG. 38 is a bottom perspective view of an inserter according to a tenth embodiment of the present invention showing an inserter having means for engaging with the implant shown in FIG. 38. FIG. 38 is a top perspective view of an inserter according to a tenth embodiment of the present invention showing an inserter having means for engaging with the implant shown in FIG. 38. A top perspective view of an inserter according to a tenth embodiment of the invention showing a partial implant-insertor assembly of the implant shown in FIG. 38 and the inserter shown in FIG. 40, wherein the implant is the first. It is a figure shown in the configuration. A top perspective view of an inserter according to a tenth embodiment of the invention showing a completed implant-insertor assembly of the implant shown in FIG. 38 and the inserter shown in FIG. 40, wherein the implant is the first configuration. It is a figure shown by. FIG. 43 is a top perspective view of the inserter of the tenth embodiment, showing the implant-insertor combination shown in FIG. 43 and showing the partial disassembly of the implant-insertor combination, wherein the implant is shown in the second configuration. It is a figure. FIG. 43 is a perspective view of one of the implant-insertor connecting means of the assembly shown in FIG. 43. FIG. 43 is a perspective view of one of the implant-insertor connecting means of the assembly shown in FIG. 43. It is a side view of the eleventh embodiment of this invention which shows the implant which has the means for engaging with an inserter. FIG. 47 is a side view of the embodiment shown in FIG. 47 showing means for engaging the inserter. It is a top perspective view of the eleventh embodiment of the present invention showing an inserter having a means for engaging with the implant of the present invention. It is a top view of the inserter shown in FIG. 49. It is a front view of the inserter shown in FIG. It is a bottom view of the inserter shown in FIG. 49. FIG. 49 is a top perspective view of an eleventh embodiment of the invention showing a partial implant-insertor assembly of the implant and inserter shown in FIG. 49, wherein the implant is shown in the first configuration. be. FIG. 5 is a bottom perspective view of the implant-insertor combination shown in FIG. 53. FIG. 49 is a top perspective view of an additional embodiment of the invention showing the completed implant-insertor assembly of the implant and inserter shown in FIG. 49, wherein the implant is shown in the first configuration. FIG. 5 is a bottom perspective view of the implant-insertor combination shown in FIG. 55. FIG. 55 is a perspective view of an eleventh embodiment showing the implant-insertor coupling means of the assembly shown in FIG. 55, wherein the implant is shown in the first configuration. FIG. 5 is a top perspective view of an eleventh embodiment showing the implant-insertor combination shown in FIG. 55 and showing the partial disassembly of the implant and the implant-insertor assembly of the inserter shown in FIG. 49. The implant is shown in the second configuration. FIG. 58 is a front view of the partial disassembly of the implant-insertor assembly shown in FIG. 58, wherein the implant is shown in the second configuration. It is a top view of the twelfth embodiment of the present invention showing an implant having a means for connecting to a bone engagement feature and various means for engaging with an inserter. It is a perspective view of the embodiment shown in FIG. It is a top view of the thirteenth embodiment of the present invention showing an implant having a means for connecting to a bone engagement feature and a means for engaging with an inserter. It is a front view of the embodiment shown in FIG. 62. It is a perspective view of the embodiment shown in FIG. 62 which shows the means for connecting to a bone engagement feature portion and the means for engaging with an inserter. It is a top view of the 14th embodiment of the present invention showing an implant having a means for connecting to a bone engagement feature and a means for engaging with an inserter. It is a bottom view of the embodiment shown in FIG. 65. It is a perspective view of the embodiment shown in FIG. 65. It is sectional drawing of the embodiment shown in FIG. 65. It is a top view of the fifteenth embodiment of the present invention showing an implant having a means for connecting to a bone engagement feature and a means for engaging with an inserter. It is a perspective view of the embodiment shown in FIG. 69. FIG. 6 is a cross-sectional view of the embodiment shown in FIG. 69. It is a top view of the 16th embodiment of the present invention showing an implant having a means for connecting to a bone engagement feature and a means for engaging with an inserter. It is a front view of the embodiment shown in FIG. 72. It is a bottom view of the embodiment shown in FIG. 72. It is a perspective view of the embodiment shown in FIG. 72. FIG. 6 is a perspective view of a seventeenth embodiment of the present invention showing an implant having means for engaging to a bone engagement feature and means for engaging with an inserter. FIG. 6 is a side view of the implant shown in FIG. FIG. 3 is a front view of an eighteenth embodiment of the present invention showing an implant having a bone engagement feature and a means for engaging the inserter. It is a perspective view of the embodiment shown in FIG. 78.

The present invention can include fastening devices and inserters. Exemplary embodiments of fastening devices and inserters are shown in FIGS. 1, 14, and 19. The fastening device may have a configuration similar to a module staple or bone plate as shown in FIG. The fastening device may have a configuration similar to bone staples as shown in FIGS. 11, 12, 15, and 16. The present invention can have inserters pre-assembled or attached to the implant, as shown in FIGS. 1 and 14. One or more implants may not be pre-assembled into the inserter. One or more implants may be held in a particular configuration in a package that facilitates engagement with the inserter. 11 and 12 show embodiments of fastening devices or implants showing one possible combination of implant configurations. 11 and 14 show this embodiment in a state maintained in the first configuration for insertion. FIG. 12 illustrates this embodiment in its free or embedded state configuration.

The embodiments described herein include, but are not limited to, various types of bone staples, bone plates, etc. with multiple implant configurations in which the insertion device does not interfere with the final placement of the implant, but any type of inserter or fixation. Can be used in connection with the device.

As shown in FIGS. 1A, 1B, 1D and 1E, the inserter 100 is assembled to the implant 120. The implant 120 is shown in the first configuration, which may or may not be flat. The inserter 100 may or may not have features that allow the bone to be prepared to receive other members of the implant. In this embodiment, the inserter 100 has tubular members 102a and 102b that allow the bone to be prepared via the inner diameter 106. The pipe members 102a and 102b can also function as a drill guide. The implant 120 is temporarily connected to the tubes 102a and 102b by engagement pins 104a and 104b. The two independent tubes 102a and 102b are individually connected to the implant 120 by engagement pins 104a and 104b. The engagement pin may or may not completely penetrate the implant. The engagement pin may be attached to the implant temporarily or permanently rather than as part of the inserter assembly. The engagement pin can extend through the implant with features that engage the bone for temporary fixation during the procedure. Further, although the use of a circular pin is shown in this embodiment, the use of other mounting means is obvious to those skilled in the art and may or may not be a piece separated from the tube member. Means for attaching the plate to the inserter are shown in the bridge area of the plate, but can be anywhere on or around the plate. The two independent tubes are held relative to each other by the clip 110. The clip 110 has means for holding during insertion or removal, a tab member 114, and two engaging pins 112. The engagement pin 112 engages the tubes 102a and 102b and holds them in relative positions to each other, thereby holding the implant 120 in its first configuration. FIG. 1E shows an inserter in which a bone screw 130 is inserted into an implant 120, the implant being maintained in its first configuration. 1C and 1D show engagement 119, with engagement pins 104a and 104b being controllably joined to the engagement hole 122 shown in FIG. The implant 120 is shown in FIG. 1A, FIG. 1B, FIG. 1D, and FIG. 1E with the first configuration. Alternatively, the inserter 100 may be used for implant manipulation or for holding the implant in the first configuration, with or without means for the preparation of other implant members, such as bone screws. Bone preparation may or may not be separate from the inserter. Bone preparation can be performed in the first and / or second configuration of the implant.

2A, 2B, 2C and 2D show the inserter 100 without the clip 110. The inserter assembly 100 is shown to depict an initial release step that may or may not allow the implant 120 to have a second configuration. In this embodiment, a bone screw 130 is prepared and placed within the implant 120. The inserter tubes 102a and 102b are still engaged with the implant 120 by engagement pins 104a and 104b. The implant 120 is shown in the second configuration and is achieved either by the inherent mechanical properties of the material or by the secondary mechanical manipulation of one or more areas of the plate. 2A, 2B, 2C, and 2D show inserters temporarily attached to the implant after bone preparation and placement of the bone screw 130. The inserter 100 is shown shortly before the removal of the inserter 100 from the implant 120. Independent inserter tubes 102a and 102b adapt to the second configuration of implant 120.

FIG. 3 shows the implant 120 in its second configuration after removal of the inserter 100 or, in some cases, after secondary mechanical manipulation / deformation. The bone screw 130 can be prepared and aligned through the inner diameter 106 while the inserter 100 is still attached to the implant 120. FIG. 3 shows an embodiment of an engagement hole 122 that receives the engagement pins 104a and 104b of the inserter tubes 102a and 102b.

FIG. 4 shows an embodiment of the inserter 100 assembled on the implant 120 on the foot 140. 5 and 6 show an embodiment of the inserter 100 assembled to the implant 120 on the foot 140, further the drill 150 through an inner diameter 106 for receiving the bone screw or other fixation feature of the implant 120. The preparation of the bone 140 by. In FIGS. 4, 5, and 6, the clip 110 keeps the tubes 102a and 102b in relative positions to each other. The clip 110 may or may not be a separate assembly and functionality may be achieved, for example, by a feature formed into a tube and integrated. Clip 110 is shown to provide a tight static connection between tube 102a and tube 102b. The coupling mechanism between the tube 102a and the tube 102b provides a dynamic and movable connection (eg, application of a spring) so that the tube can somehow fit the plate to the bone before the clip 110 can be completely removed. You may have. The tubes 102a and 102b are controlledly engaged with the implant 120 via the engagement pins 104a and 104b and the engagement feature 122. In this embodiment, the clips 110, tubes 102a and 102b, engagement pins 104a and 104b, and engagement holes 122 work together to keep the implant 120 in the first configuration. In alternative embodiments, more or less components may be required to keep the implant in the first configuration.

FIG. 7 shows an embodiment of the inserter 100 assembled on the implant 120 on the foot 140. This figure shows the first removal step of this particular embodiment of the Inserter 100. Therefore, in FIG. 7, the bone is prepared and the implant 120 is in its final position on the bone and is its first configuration. FIG. 7 shows the removal of the clip 110 from the inserter 100. As further shown in FIG. 8, by removing the clip 110 from the inserter 100 after completing proper bone preparation, the implant 120 can be adapted to the second configuration while the implant 120 is in the final implant position. become. Bone screw 130 (not shown in FIG. 7 or 8) may or may not be prepared while the inserter assembly 100 was engaged with the implant 120. FIG. 9 shows the implant 120 on the bone 140 after removal of the inserter assembly 100 after the implant 120 is in its final position before or after achieving its second configuration.

FIG. 10A shows exemplary embodiments of the inserter assembly 100 and implant 120, as well as a preparatory step with a drill 150 aligned with an inner diameter 106 of tubes 102a and / or 102b. 10A, 10B, and 10C show the implant 120 controlledly engaged to the tubes 102a and 102b by engagement pins 104a and 104b (pins not shown) engaged to the engagement hole 122. Is further shown. Clip 110 keeps the tubes controllable with respect to each other using engagement pins 112 engaged in the tubes 102a and 102B. The drill 150 has a grooved region 152, a shaft 154, and a stop 156. 10B and 10C show a drill stopper 156 abutting on the upper surface of the drill tube 102a or 102b. The stopper 156 can be used to prevent the drill from extending too far into the bone during preparation. The stopper 156 can be used to control the drill depth so that the grooved region 152 projects only through the drill guide / tube 102a and / or 102b to a predetermined depth.

In this exemplary embodiment, the implant 120 can be made of a material that can have elastic or spring properties that allow the implant to have multiple configurations. FIG. 3 shows the implant 120 in the possible free or embedded state of the device. The free or embedded state can result in compression (or extension) across the bone element. FIG. 3 shows an implant 120 with a thickness of 126 and a bridge member 124. FIG. 3 further shows the implant 120 having an arc or radius 128 while in its second configuration. FIG. 3 also shows an example of a bone mounting device 130 that resembles a bone screw in this case, in which case the example resembles a bone screw. The mounting device 130 is firmly mounted to the implant 120 via the mounting feature 129. The mounting feature 129 thereby allows the bone mounting device to be locked to a material that may have elastic properties. The bridge member 124 shown in FIG. 3 also has an engagement feature 122 for controllably engaging the inserter to maintain the first configuration. The embodiments thus shown allow the implant 120 to be fully seated in the bone at its final position without the inserter interfering with this final position. When the implant is placed in its final position, the implant may or may not be in its second configuration. The implant may remain in the first configuration until the inserter is removed or further manipulated.

FIG. 11 shows an exemplary embodiment of an implant 200 that resembles a bone staple. The implant is shown in a first configuration in which the legs 220 are relatively parallel to each other. This first configuration may be useful in facilitating the implantation of the implant 200 into the bone. The first configuration may be a configuration maintained by an inserter. FIG. 11 shows an implant 200 with a bridge member 210 having a thickness of 202. The thickness 202 may or may not be thicker or thinner than the thickness 204. This particular embodiment shows that the bridge member 210 has a roundness 206. The roundness 206 may or may not be present. FIG. 11 further shows a leg 220 having a feature 230 for engaging the inserter. The engaging feature 230 may be an internal feature or an external feature and may be aligned to the inside or outside of the leg 230. It is also reasonable to have an engagement feature similar to the engagement hole 122 in this type of device. The implant 200 has a bone engaging means in the form of barbs 225 that engage the bone to maintain the implant in the bone. FIG. 12 shows the implant 200 of FIG. 11 in a second configuration. In this particular configuration of FIG. 12, the legs 220 converge with respect to each other. One or more legs may move to form this convergence or extension. The second configuration can be free or embedded.

FIG. 13 shows another embodiment of the inserter 240. The inserter 240 has a holding piece 242 and at least one engaging pin 244. The engagement pins 244 are properly spaced and oriented to interact with the implant to maintain the first configuration. FIG. 14 shows the inserter 240 assembled to the implant 200. The engagement pin 244 of the inserter 240 engages the inner diameter 230 of the implant 200 to keep the implant 200 in the first configuration. When the inserter 240 is removed, the implant takes a second configuration as shown in FIG.

FIG. 15a shows yet another embodiment of the implant or fixation device 300. The implant 300 has a bridge member 310 and a leg member 325. The bridge member 310 has a thickness 315 that may or may not be the same as the leg thickness 320. FIG. 15A shows the implant in the first configuration. FIG. 15B shows the implant 300 in a second configuration. The implants of FIGS. 15A and 15B are also shown in FIGS. 16A and 16b depicting an inner diameter of 330. The opening 340 is created by the inner diameter 330 splitting inward of the leg. The opening 340 may or may not be required in the present invention. The inner diameter 330 can be used to engage the inserter and maintain the implant in a particular configuration. The inner diameter 330 may be used to manipulate the implant to have a different configuration, the relationship between the implant legs 325 being modified by creating a convergent, divergent, or some other out-of-plane relationship. You may.

Alternative embodiments can include inserters and implants that work in association to make the first and second configurations.

FIG. 17A shows an embodiment of the implant 300 in the inserter 400, with the implant in the first configuration. FIG. 17B shows the same embodiment in which the implant 300 is at the end of the engagement pin 410 of the inserter 400. The implant in FIG. 17B is moving to a second configuration. FIG. 17C shows the implant 300 completely disengaged from the inserter 400. The implant 300 is in the second configuration. 18A, 18B, and 18C are perspective views showing embodiments of FIGS. 17A, 17B, and 17C.

The embodiments shown herein demonstrate the engagement between the implant and the inserter as using a pin. It will be appreciated by those skilled in the art that various means can be used to attach the implant to the inserter.

19 and 20 show embodiments of the inserter 500 pre-assembled into the implant 300. The inserter 500 has holding means 510 and impact or seating means 530. The handle 520 is slidably engaged with the body 505. The assembly 500 has means 515 for engaging the implant. In this embodiment, the engaging means is a pin 515. The pin 515 is coupled to the handle 520 such that the pin retracts from the implant 300 and releases or releases the implant from the inserter assembly 500. In this embodiment, the pin or engaging means is retractable. As will be appreciated by those skilled in the art, the same effect can be achieved without retractable engaging means, in which case the implant is engaged by a plunger type mechanism that pushes the implant out of or out of the inserter assembly. It may be pushed out of the means.

21 and 22 show embodiments of implants with alternative configurations. It will be appreciated by those skilled in the art that this embodiment is similar to bone staples, but this embodiment may be accomplished by modular fixing means such as bone screws. Implant 600 comprises a bridge member 610 with a thickness of 615. The bridge member 610 is connected to a fixing member or a leg 620. The legs 620 are out of plane with respect to each other. The legs 620 may or may not be out of plane with respect to the bridge member 610. The implant 600 can have an engagement feature 630 for controlling and / or manipulating the implant to make it an alternative configuration. The engagement feature 630 may or may not penetrate the entire implant. The engagement feature 630 may be a positive or negative feature in the implant or inserter. This alternative configuration may or may not be achieved due to the unique material properties of the implant material. The implant can achieve this alternative configuration, for example, by transitioning from configuration 1, configuration 2, and then configuration 3. In this case, configuration 1 may be attached to an inserter or delivery device, configuration 2 may be a configuration in which the leg member 620 is in a compressed state, and configuration 3 may be a configuration in which the leg member 620 is compressed. The legs may be configured to be out of plane with each other. Alternatively, the implant may achieve this alternative configuration, for example by transitioning from configuration 1 to configuration 2. In this case, configuration 1 may be attached to an inserter or delivery device, and configuration 2 may be such that the leg members 620 are in a compressed state and are out of plane with each other. This embodiment is not intended to be limiting. The migration from one configuration to another can be one separate migration or multiple separate migrations. The migration may be due to unique material properties, achieved by manipulation of the material, or a combination thereof.

The embodiments described herein can be made from several different materials or combinations of materials. For example, nitinol can provide material properties such as shape memory and / or superelasticity that can provide the unique properties that allow an implant to have multiple configurations, with or without external mechanical manipulation. Have. Stainless steel and / or titanium also have the desired material properties for the embodiments described herein. Stainless steel and / or titanium do not have shape memory or hyperelasticity, but can have mechanical properties for embodiments that can benefit from mechanical manipulation to achieve multiple configurations. Other materials, such as PEEK or other polymers, may also have material properties that are beneficial to the embodiments described herein. A combination of materials may be preferred. For example, a nitinol plate with titanium screws may be the material of choice for some embodiments. Those skilled in the art will recognize typical materials and combinations of materials applicable to the present invention.

Yet another embodiment of the invention is assembled to a holding means such as a device or carrier that can be assembled to the inserter during surgery, as shown in FIGS. 23A, 23B, 24, and 25-28. Can have an implant to be used.

23A and 23B show an exemplary embodiment 700 of the implant carrier assembled in the implant embodiment 800. FIG. 23A is a front view of the assembled body, and FIG. 23B is a side view of the assembled body. FIG. 24 shows a carrier 700 slidably engaged with the implant 800. The implant 800 has a feature portion 810 for receiving the engagement feature portion 710 of the carrier. The carrier 700 can have features and / or geometry 720 for engaging the inserter. The carrier 700 can further have features and / or geometry 730 for engaging with the inserter. Engagement features and / or geometries 720 and 730 can be used separately or in combination to provide Pokayoke features that prevent inaccurate assembly of carriers to inserters. The feature 720 and / or 730 may be used to assist the inserter in removing the carrier from the implant, i.e., releasing the implant from the carrier during implantation. The carrier 700 may be configured to fit implants of multiple sizes. The engagement feature portion 710 of the carrier 700 may vary in size in order to optimize the fit between the implant 800 and the carrier 700. The engagement features of the carrier (eg, 720 and 730) may or may not vary depending on the implant size. Matching features across different implant sizes in this way allows the use of multiple implant carriers with the same inserter.

FIG. 25 more clearly shows the carrier 700 without the implant. As mentioned above, the carrier 700 has a feature 710 that allows the implant to be slidably or otherwise mounted or anchored in place on the carrier. The inserter engagement feature portion 720 can have a plurality of configurations or geometric shapes. The engagement feature 720 can provide engagement with the inserter that allows the inserter to retract the carrier from the implant 800. The engagement feature portion 730 may be used for attachment to the inserter, and may also provide a Pokayoke feature portion for preventing improper assembly of the carrier 700 to the inserter. It will be apparent to those skilled in the art that the functions of features 720 and 730 may be combined or replaced to achieve the same uses and functions as described in this embodiment.

26A and 26B show exemplary embodiments of the inserter 900 and implant 800 assembled to the carrier 700. FIG. 26A shows an inserter 900 with an implant carrier 700 before assembling the carrier 700 to the inserter 900. FIG. 26B shows a carrier 700 with the attached implant 800 assembled to the inserter 900. In this exemplary embodiment, the inserter 900 has a base component 910, a handle component 920, and a locking means 930. The inserter can also have a holding member 940 that can be used to assist in keeping the carrier 700 in a designated position. The holding member 940 may or may not be integrated with the handle component 920. This inserter embodiment has a feature portion 950 for engaging with the carrier 700 by Pokayoke means. The locking means 930 can be used to secure the handle component 920 to the base component 910.

27A and 27B show exemplary embodiments of FIGS. 26A and 26B in upright isometric views. FIG. 27A shows the carrier 700 and the implant 800 attached to the inserter 900 before releasing the implant 800 from its carrier 700. FIG. 27B shows an embodiment for releasing the implant 800 from the carrier 700. FIG. 27B shows a handle 920 in a retracted position where the carrier 700 is removed from the implant 800. In the state shown in FIG. 27B, the implant is then free from the carrier 700. The carrier 700 may be removed from the inserter 900 and replaced with another implant / carrier assembly.

FIG. 28 shows exemplary embodiments of the inserter 900, carrier 700, and implant 800 that allow the implant 800 to be seated snugly on the bone surface 1000. It should be noted that the inserter 900 does not interfere with the final placement of the implant 800. Implant 800 with a second configuration in which the parallel legs can converge after release from the inserter 900 and carrier 700 does not perform secondary final seating of the implant after release from the insertion device. Is beneficial.

FIG. 29 is an enlarged view of the implant inserter interface of another exemplary embodiment of the inserter 1100 and implant 1200. The inserter 1100 has means 1120, 1130, and 1110 for attaching to the implant. These mounting means engage the implant 1200 without interfering with its final seating in its final desired position. FIG. 30 shows one possible means for releasing the implant 1200 from the inserter 1100. This embodiment performs rotation of the inserter 1100 with respect to the implant 1200. This rotation releases the engaging means 1120 and 1130 while rotating around the pin 1110. Once fully rotated and released, the inserter 1100 can be removed from the implant 1200.

FIG. 31 shows the aforementioned inserter embodiments 100 and 110 assembled to the implant 120. FIG. 31 further shows an embodiment of the engaging means 190 that intentionally protrudes from the implant 120. The engaging means 190 shown can have a tip configured to penetrate the bone surface and provide temporary fixation.

FIG. 32 shows an embodiment of an implant 1600 that includes a plurality of connecting means (means for fixation to bone) 1620 for receiving a bone engaging member. The bone engaging member may be a bone screw, peg, blade, or other means suitable for engaging with bone or soft tissue. The connecting means 1620 can be of the same or different mode or geometry for a particular implant. For example, some of the connecting means 1620 in the implant 1600 may be screwed and / or locked, while others may be unscrewed or unlocked. Implant 1600 has a bridge region 1601 spanning the connecting means 1620. The bridge region 1601 may or may not have a plurality of rails or members 1602. In this particular embodiment, two rail members 1602 defining a space 1603 having an outer peripheral portion 1645 are shown. As further shown in FIG. 33, the space 1603 has lower surfaces 1641 and 1642 recessed from the bottom surface 1640. The bottom surfaces 1641 and 1642 may have similar or different configurations and / or geometries suitable for engaging with the means of insertion. FIG. 34 shows an inserter 1650 engaged to implant 1600. The inserter 1650 has two members 1652 and 1651 having a space 1655 inside it. FIG. 34 shows the implant 1600 held in a first configuration that may or may not be flat. This first configuration can facilitate surgical implantation. This first configuration can act to store compressive or other forces. FIG. 35 shows an inserter 1650 partially disengaged from implant 1600. The members 1651 and 1652 come together to reduce the space 1655 that allows or facilitates the assembly and / or disassembly of the inserter 1650 and implant 1600. As shown in FIG. 35, when the inserter 1650 is disengaged from the implant 1600, the implant can take a second configuration. This second configuration can be achieved by the design of the implant 1600 and / or in combination with the implant's unique material properties and / or in combination with the treatment of the implant 1600. This second configuration can act to provide compressive or other forces across one or two bone or tissue segments.

FIG. 36 shows the implant 1600 releasably attached to the inserter 1650. The implant engaging means 1660 and 1661 of the inserter 1650 can engage the implant 1600 by joining to the implant surfaces 1641 and 1642. The arms of the inserters 1651 and 1652 can pass through space 1603 to engage the implant 1600.

FIG. 37A shows a possible cross section of the implant-insertor combination. The implant is shown in the first configuration. The arms 1651 and 1652 of the inserter 1650 can pass through the space 1603 of the implant, thereby allowing the upper surfaces 1671 of the engaging members 1660 and 1661 to join the lower surface 1641 of the implant 1600. When the inserter arms 1651 and 1652 are engaged, they can provide the force to keep the implant in the first configuration. In this exemplary embodiment, an inserter 1650 is shown that passes through the interior space 1603 of the implant 1600. In other embodiments, the inserter may engage the external features as shown herein. In this embodiment, the general shape of the engagement is shown as an "L" shaped interface. However, it will be apparent to those skilled in the art that a large number of geometries and configurations or combinations of geometries and configurations are possible and may be included in the present invention. FIG. 37B shows some possible alternative geometries for coupling to means of insertion that can be used to maintain a particular implant configuration. FIG. 37B shows a geometry 1690 that can be generally "L" shaped. FIG. 37B shows a geometry 1691 that can be a generally slanted or tapered surface or chamfered end. FIG. 37B shows geometry 1692, which may be generally screwed or other fastening geometry. FIG. 37B shows a geometry 1693 that can generally represent a bending mode in which a particular geometry can be utilized in combination with a location on the implant surface to maintain a particular implant configuration. FIG. 37B shows a geometry 1694 that can be a combination of a generally square geometry and an "L" shaped geometry. The means of insertion may or may not be coplanar with the implant. The combination of features can be used to maintain the implant in a particular configuration or combination of configurations. Several combinations may be used to retain a particular implant feature in a configuration that may be the same as or different from the entire implant. For example, some features or combinations of features may be used to hold one arm or protrusion of the implant upwards, while other features or combinations of features may be different for the implant. It may be used to hold the arm or protrusion or part downward. This allows certain aspects of the implant to achieve different configurations. The means of connection and insertion between the implant and the inserter can hold the implant in a first configuration and / or an alternative configuration. Once the inserter and implant are disassembled, the disassembly can allow the implant to achieve a second or alternative configuration. This disassembly can allow the implant to achieve multiple alternative configurations. For example, step 1 of disassembly can allow the implant to achieve a second configuration, step 2 can allow the implant to achieve a third configuration, and step 4 of disassembly allows the implant to achieve a third configuration. It is possible to achieve the third configuration. This disassembly can allow the implant or part of the implant to achieve multiple alternative configurations. For example, step 1 of disassembly can allow a portion A of the implant to achieve a second configuration, and step 2 can allow a portion B of the implant to achieve an alternative configuration, a step of disassembly. 4 can allow the implant portion C to achieve an alternative configuration. It will be appreciated by those skilled in the art that alternative configurations of implants or combinations of implant portions may be possible by the present invention. Some alternative configurations may be intermediate configurations that revert to the previous configuration, or may proceed to the final configuration once completely disassembled from the inserter. The embodiments described herein do not limit the scope of the invention. Further embodiments and combinations of embodiments may be possible and will be apparent to those of skill in the art. The invention can include inserter and inserter-implant combinations that can be used with implants having one or more configurations.

The implants of the invention can be assembled into an inserter or other delivery device by some means apparent to those of skill in the art. The implant may be pre-assembled at the time of packaging or may be assembled at the time of use. The implant may be pre-located in the first configuration and then assembled into the inserter. The implant may be pre-positioned by various means to achieve the first configuration for assembly with the inserter. Alternatively, the implant may be pre-positioned by various means to achieve a pre-assembly configuration for assembly with the inserter, the pre-assembly configuration being equivalent to the first or second configuration. It may not be. The implant may be pre-positioned by various means to achieve this alternative configuration for assembly with the inserter, or physical deformation of the implant such as bending or mechanical manipulation, eg assembly to the inserter. It may be pre-positioned by other delivery devices that may include applying force to the implant on a flat surface or other surface to temporarily hold the implant in a mounting shape. Implants can include the application of external temperature changes due to heating, cooling, and / or freezing, which can create changes in the physical properties of the material such as facilitating alternative construction for assembly. It may be pre-located by various means to achieve this alternative configuration for assembly with the inserter. Implants may be pre-placed by various means to achieve this alternative configuration for assembly or reassembly with an inserter, which may include assembly or reassembly at the time of use. If the implant is already partially or fully aligned or implanted, the implant may be of sufficient configuration to allow reassembly of the inserter or other instrument. This can have advantages over existing techniques and can be beneficial to allow implant removal, repositioning, or other forms of adjustment. In addition, the advantages of the invention can also include the ability of the end user to assemble a multi-configuration implant into the instrument during use. As shown in the embodiments described herein, the inserter delivers a means for assembly, a means for maintaining a first implant configuration, and / or an implant to achieve an alternative configuration. Can be designed to provide a means for. The instrument is chamfered, tilted, stepped, shouldered, mechanically leveraged, to operate the implant from an alternative configuration to a first configuration for assembly means to maintain the first configuration. Features such as mechanical interfaces and complementary geometries can be included. The means of assembly may be accomplished by a single feature or a single feature on a single inserter or delivery device. Assembling means may be accomplished by a single feature or feature on a single inserter or delivery device, or by the use of multiple delivery devices used sequentially or in combination.

FIG. 38 shows an embodiment of the implant 1900 of the present invention in a “T” shape. Implants can take a variety of configurations. The advantages of the present invention are not limited by the shape or style of the implant. In FIG. 38, the implant 1900 is shown in the first configuration. Implant 1900 can include multiple connecting means for the bone engaging member. The bone engaging member may be a bone screw, peg, blade, or other means suitable for engaging with bone or soft tissue. The connecting means 1930 can be of the same or different mode or geometry for a particular implant. For example, some of the connecting means 1930 in the implant 1900 may be screwed and / or locked, and others may be unscrewed or unlocked. The implant 1900 can include a connecting portion 1925 for the means of insertion that is an external feature and can also include a connecting portion 1920 for the means of insertion that is internal. Implant 1900 can include multiple connections 1920 and / or 1925 for means of insertion that can vary in size, geometry, orientation, and / or configuration. Implant 1900, as shown in FIG. 38, has a top surface 1910 that can be of uniform shape, size, geometry, and / or configuration. FIG. 39 shows a perspective view of the implant 1900. Implant 1900 can have a top surface 1910 and a bottom surface 1901. In FIG. 39, implant 1900 can have rail or bridge members 1911 that can be of various sizes, geometries, and / or configurations. The bridge member 1911 may or may not have the same size, shape, geometry, and / or orientation as the top surface 1910 or bottom surface 1901. Implant 1900 can have one or more arms or protrusions 1902 that can extend from the implant. In FIGS. 38 and 39, the implant 1900 is shown in a flat configuration or a first configuration. The first configuration may or may not be flat. The first configuration may be flat, slanted, arched, or bent, or may be a combination of several of these. This first configuration can facilitate surgical implantation. This first configuration can act to store compressive or other forces.

40 and 41 show an embodiment of the inserter of the present invention. The inserter 1950 is configured to interact with and / or engage with the implant 1900 shown in FIG. The inserter 1950 can hold the implant in the first configuration. The inserter 1950 has connecting means 1954 that can be used to engage a separate handle or other holding means. This exemplary embodiment can also have feature 1951 in various positions, orientations, or configurations. One or more feature portions 1951 can be present in a particular implant. Feature 1951 can be used to temporarily or temporarily attach a combination of inserter and implant to a surface such as bone or tissue. Pins or other means can be used to pass through feature 1951 to maintain the relative position of the inserter or inserter-implant combination on the bone or tissue. The invention can include inserter and inserter-implant combinations that can be used with implants having one or more configurations. The inserter 1950 can have implant connecting means 1955 for releasably and / or rotatably engaging with the implant. The inserter 1950 can include at least a second implant connecting means 1965 for releasably engaging the implant. The connecting means 1965 and 1955 may or may not have the same size, shape, geometry, orientation, and / or configuration. FIG. 41 is a top perspective view showing how the temporary fixing means 1951 extends from the top surfaces 1952 and 1953 to the bottom surfaces 1971 and 1970. The surfaces 1970 and 1971 may or may not be in the same plane or in the same configuration.

FIG. 42 shows an inserter 1950 partially engaged with the implant 1900. The implant 1900 may be held in the first configuration by the engaging features 1965 and 1955 of the inserter 1950. FIG. 43 shows the implant 1900 fully engaged with the inserter 1950. The implant 1900 is maintained in the first configuration by the interactions 1980 and 1981 between the implant 1900 and the inserter 1950. As the means of insertion, the same feature as 1925 described herein can be utilized in combination with other surfaces such as the top surface 1910. This combination of insertion means 1925 and surface 1910 can be used to maintain one or more features or arms or protrusions 1902. Combinations of insertion means such as 1925, 1910, and / or 1920 may be used to create bending modalities such as 3-point bending or 4-point bending to maintain a particular implant configuration or combination of configurations. .. Combinations of surfaces with means of insertion such as 1925, 1910 and / or 1920 may be used in the entire implant or in parts of the implant to create or maintain a particular configuration of the implant or part of the implant. For example, tabs such as 1925 and surfaces such as 1910 may be used to maintain one arm or protrusion such as 1902 of the implant in a particular configuration. When disassembled, the arm may have a different or identical configuration than the rest of the implant.

FIG. 44 shows an inserter 1950 partially disassembled from implant 1900. When the implant 1900 disengages from the inserter 1950, the implant 1900 can achieve a second configuration. This second configuration can be achieved by the design of the implant 1900 and / or in combination with the implant's unique material properties and / or in combination with the treatment of the implant 1900. This second configuration can act to provide compressive or other forces across one or two bone or tissue segments.

FIG. 45 shows the interaction 1980 between the implant 1900 and the inserter 1950. The surface 1965 can be releasably engaged or interacted with the connecting means 1925 of the implant 1900. The interaction or interface 1980 can act in combination with the interaction or interface 1981 to keep the implant in the first configuration. The feature portion 1955 of the inserter 1950 can be releasably engaged with the feature portion 1920 of the implant 1900. This interaction or interface can allow rotation, swiveling, latching, or other movements to facilitate assembly or interaction between the implant and the inserter.

An embodiment of the invention shown in FIG. 47 is an implant 2100 having a top surface 2110 and one or more connecting means 2101 for a bone engaging member. The bone engaging member may be a bone screw, peg, blade, or other means suitable for engaging with bone or soft tissue. The connecting means 2101 can be of the same or different mode or geometry for a particular implant. For example, some of the connecting means 2101 in the implant 2100 may be screwed and / or locked, while others may be unscrewed or unlocked. The implant 2100 can have one or more means 2140 and 2120 for connecting to an inserter or other means of insertion. One embodiment of means 2140 can have a top surface 2141 and a bottom surface 2145, as shown in FIG. The means 2140 may or may not be in close proximity to the connecting means 2101. The embodiment of the implant 2100 of FIG. 47 is shown in the first configuration.

The advantages of the present invention and embodiments shown in FIGS. 42-46 are numerous and can include the ability of the means of insertion to maintain the implant in the first configuration. These embodiments can also allow the implant-insertor combination to be temporarily or temporarily fixed to a bone or tissue segment while maintaining the implant in the first configuration in the method of implantation. .. The inserter can be releasably engaged with the implant to facilitate assembly and disassembly of the implant and inserter. Assembly and disassembly are done in a direction or movement that contributes to the surgical procedure. When the implant and inserter are completely disassembled, the implant can achieve a second configuration. This second configuration can be achieved by the design of the implant and / or in combination with the implant's unique material properties and / or in combination with the treatment of the implant 1600. This second configuration can act to provide compressive or other forces across one or two bone or tissue segments. The implant may or may not be pre-assembled into the inserter in the final packaging.

49, 50, 51, and 52 show the inserter 2000 of the present invention. The inserter 2000 may or may not have connecting means 2060 for attachment to a handle or other holding means. The inserter 2000 can have one or more features 2011 and 2012 for temporarily attaching the inserter to one or more bone or tissue segments. The inserter can have means 2040 and 2041 for releasably engaging the implant in order to keep the implant in a configuration different from the implant's first configuration or implant configuration. The inserter 2000 can have one or more protrusions or arms 2020 and 2010 to facilitate connection to the implant. The inserter 2000 can have bottom surfaces 2030, 2040, and 2050 to engage and / or facilitate connection to the implant.

53 and 54 show the inserter 2000 partially assembled to the implant 2100. The implant may be retained or maintained in the first configuration. The top surface 2110 of the implant 2100 can be slidably joined to the bottom surfaces 2030 and 2040 of the inserter 2000. These surfaces may be coplanar and may or may not be physically engaged with each other. The surface 2040 of the inserter 2000 can be releasably engaged with the bottom surface 2145 of the means 2140 on the implant 2100. The surface 2041 of the inserter 2000 can be releasably engaged with the bottom surface 2125 of the means 2120 on the implant 2100. The engagement between the surface 2041 and the surface 2125 may occur at the same time as the engagement between the surface 2040 and the surface 2145. This interaction can keep the implant 2100 in the first configuration. The engagement of the surface 2041 with the surface 2125 and the engagement of the surface 2040 with the surface 2145 can occur from opposite directions that may require the inserter 2000 to swivel with respect to the implant 2100. This engagement can occur from the same direction as the sliding or top loading motion. These advantages of the present invention are maintained regardless of the direction of assembly.

55 and 56 show the inserter 2000 fully or fully assembled to the implant 2100. The implant may be retained or maintained in this first configuration. FIG. 55 shows the implant 2100 held in a first configuration that may or may not be flat. The first configuration may be flat, slanted, arched, or bent, or may be a combination of several of these. This first configuration can facilitate surgical implantation. This first configuration can act to store compressive or other forces. The top surface 2110 of the implant 2100 can be slidably joined to the bottom surfaces 2030 and 2040 of the inserter 2000. These surfaces may be coplanar and may or may not be physically engaged with each other. The surface 2040 of the inserter 2000 can be releasably engaged with the bottom surface 2145 of the means 2140 on the implant 2100. The surface 2041 of the inserter 2000 can be releasably engaged with the bottom surface 2125 of the means 2120 on the implant 2100. The engagement between the surface 2041 and the surface 2125 may occur at the same time as the engagement between the surface 2040 and the surface 2145. This interaction can keep the implant 2100 in the first configuration. The engagement of the surface 2041 with the surface 2125 and the engagement of the surface 2040 with the surface 2145 can occur from opposite directions that may require the inserter 2000 to swivel with respect to the implant 2100. This engagement can occur from the same direction as the sliding or top load motion. These advantages of the present invention are maintained regardless of the direction of assembly.

FIG. 57 shows the interaction of retention means between the inserter 2000 and the implant 2100. The top surface 2041 slidably engages the bottom surface 2125 of the implant 2100. This can provide the support needed to keep the implant in the first configuration, or the configuration can differ from the implant configuration. In this embodiment, the general shape of the engagement is shown as an "L" shaped interface. Alternative geometries and / or configurations may be used as previously described herein. However, it will be apparent to those skilled in the art that a large number of geometries and configurations or combinations of geometries and configurations are possible and may be included in the present invention. Other possible alternative embodiments of geometry for coupling to the means of insertion are described herein. The means of insertion may or may not be coplanar with the implant. The means of connection and insertion between the implant and the inserter can hold the implant in a first configuration and / or an alternative configuration. Once the inserter and implant are disassembled, the disassembly can allow the implant to achieve a second or alternative configuration. This disassembly can allow the implant to achieve multiple alternative configurations. For example, step 1 of disassembly can allow the implant to achieve a second configuration, step 2 can allow the implant to achieve a third configuration, and step 4 of disassembly allows the implant to achieve a third configuration. It is possible to achieve the third configuration. This disassembly can allow the implant or part of the implant to achieve multiple alternative configurations. For example, step 1 of disassembly can allow a portion A of the implant to achieve a second configuration, and step 2 can allow a portion B of the implant to achieve an alternative configuration, a step of disassembly. 4 can allow the implant portion C to achieve an alternative configuration. It will be appreciated by those skilled in the art that alternative configurations of implants or combinations of implant portions may be possible by the present invention. Some alternative configurations may be intermediate configurations that revert to the previous configuration, or may proceed to the final configuration once completely disassembled from the inserter. The embodiments described herein do not limit the scope of the invention.

58 and 59 show the implant 2100 disengaged or disengaged from the inserter 2000. Implant 2100 is made possible to achieve a second configuration, or a configuration different from that maintained by the inserter. This second configuration can be achieved by the design of the implant 2100 and / or in combination with the implant's unique material properties and / or in combination with the treatment of the implant 1600. This second configuration can act to provide compressive or other forces across one or two bone or tissue segments. The means of connection and insertion between the implant and the inserter can hold the implant in a first configuration and / or an alternative configuration. Once the inserter and implant are disassembled, the disassembly can allow the implant to achieve a second or alternative configuration. This disassembly can allow the implant to achieve multiple alternative configurations. For example, step 1 of disassembly can allow the implant to achieve a second configuration, step 2 can allow the implant to achieve a third configuration, and step 4 of disassembly allows the implant to achieve a third configuration. It is possible to achieve the third configuration. This disassembly can allow the implant or part of the implant to achieve multiple alternative configurations. For example, step 1 of disassembly can allow a portion A of the implant to achieve a second configuration, and step 2 can allow a portion B of the implant to achieve an alternative configuration, a step of disassembly. 4 can allow the implant portion C to achieve an alternative configuration. It will be appreciated by those skilled in the art that alternative configurations of implants or combinations of implant portions may be possible by the present invention. Some alternative configurations may be intermediate configurations that revert to the previous configuration, or may proceed to the final configuration once completely disassembled from the inserter. The embodiments described herein do not limit the scope of the invention. Further embodiments and combinations of embodiments may be possible and will be apparent to those of skill in the art. The invention can include inserter and inserter-implant combinations that can be used with implants having one or more configurations.

It will be appreciated by those skilled in the art that, based on the description herein, various mechanisms can be created as a means of insertion capable of retaining the implant in one configuration that may differ from the second configuration or implant configuration. Will be done. The advantages of the present invention are particularly beneficial in applications where the implant can have a means for connecting to a bone engaging member such as a bone screw or peg. Controlling the ability of an implant to have multiple configurations is beneficial to ensure proper implant size, orientation, placement and / or fixation to one or more bone or tissue segments.

60 and 61 show yet another embodiment of the implant 1400 having multiple means of connecting to the inserter. This embodiment of the implant 1400 can combine the connecting internal means 1410 with one or more connecting external means 1412. The means for connecting to the inserter may or may not be close to the means for connecting to the bone engagement feature 1420. Various means of connecting to the inserter can be used in combination with various implant configurations. 62, 63, and 64 show a means of connection to an inserter 1710 that can include a tab consisting of a top element 1720 and a bottom element 1730 that can form a space 1725. Implant 1700 has an upper surface 1701 and a bottom surface 1702 that may include at least one or more thinner areas 1703. The combination of surfaces 1701, 1702, and 1703 can constitute a bridge or rail member designed to achieve a second configuration or to predict or determine the geometry of the second configuration. As the means of insertion, the same feature as 1710 described herein can be utilized in combination with other surfaces such as the top surface 1701. This combination of means of insertion can be used to maintain one or more features or arms or protrusions. This combination of means of insertion may be used to create bending modalities such as 3-point or 4-point bending to maintain a particular implant configuration or combination of configurations. Combinations of surfaces and means of insertion, such as 1710, may be used in the entire implant or in parts of the implant to create or maintain a particular configuration of the implant or part of the implant. For example, tabs such as 1710 and surfaces such as 1701 may be used to maintain one side, one arm, one protrusion, and / or part of the implant in a particular configuration. When disassembled, the arm may have a different or identical configuration than the rest of the implant.

FIG. 65 shows the implant 1200 in the first configuration. The implant 1200 has one or more connecting means 1220 for fastening the bone engaging member to the implant. The connecting means 1220 can have a number of geometries for connecting the bone engaging member to the implant. For example, these connecting means 1220 may be any or a combination of screws, lock geometry, or fitting geometry that contributes to the connection with the bone engaging member. Those skilled in the art will appreciate the various options available for connecting implants to bone engaging members such as bone screws or pegs. Implant 1200 has means 1210 and 1211 for attaching to the inserter. FIG. 65 shows the inserter mounting means 1210 and 1211 as mirror images. These means may be any number of geometries or orientations. Exemplary embodiments are described herein. Implant 1200 can have one or more inserter connecting means. These connecting means may have similar geometries or may differ significantly in geometry. In this embodiment, the inserter connecting means 1210 and 1211 have an upper surface 1230 and lead from the upper surface 1230 to the lower surface 1240. As shown in FIGS. 65, 66, and 67, the insertion connecting means can have different geometries on the top surface 1230 and the bottom surface 1240. In this embodiment, the inserter connecting means 1210 and 1211 have a geometry that provides a bottom surface 1245. The passages for 1210 and 1211 work with the bottom surface 1245 and are involved in the fitting geometry of the inserter to hold the implant in a first configuration that can be flat or have some non-linear geometry. Can be matched. The feature portion of this embodiment is further shown in FIG. 68 in a cross-sectional view. The lower surface 1245 of the inserter connecting means 1210 and 1211 does not have to be the same height or orientation as the lower surface 1240 of the implant 1200.

FIG. 69 shows the implant 1300 in the first configuration. The implant 1300 has one or more connecting means 1320 for fastening the bone engaging member to the implant. The connecting means 1320 can have a number of geometries for connecting the bone engaging member to the implant. For example, these connecting means 1320 may be any or a combination of screws, lock geometry, or fitting geometry that contributes to the connection with the bone engaging member. Those skilled in the art will appreciate the various options available for connecting implants to bone engaging members such as bone screws or pegs. Implant 1300 has means 1310 and 1311 for attaching to the inserter. FIG. 70 shows the inserter mounting means 1310 and 1311 as mirror images. These means may be any number of geometries or orientations. Exemplary embodiments are described herein. Implant 1300 can have one or more inserter connecting means. These connecting means may have similar geometries or may differ significantly in geometry. In this embodiment, the inserter connecting means 1310 and 1311 have an upper surface 1330, which leads from the upper surface 1330 to the lower surface 1340. As shown in FIGS. 69, 70, and 71, the inserter coupling means can have different geometries on the top surface 1330 and the bottom surface 1340. In this embodiment, the inserter connecting means 1310 and 1311 have a geometry that provides a bottom surface 1345. The passages for 1310 and 1311 work with the bottom surface 1345 and are involved in the fitting geometry of the inserter to hold the implant in the first configuration, which can be flat or have some non-linear geometry. Can be matched. The feature portion of this embodiment is further shown in FIG. 71 as a cross-sectional view. The lower surface 1345 of the inserter connecting means 1310 and 1311 does not have to be at the same height or orientation as the lower surface 1340 of the implant 1300.

72, 73, 74 and 75 show the implant embodiment 1500 of the present invention. Implant 1500 can utilize the geometry of the rail or bridge member 1501 as a means for connecting to the inserter. The rail or bridge member may be used to determine or predict the second configuration and may also be used as a connecting means for the inserter. The bridge member 1501 has an upper surface 1530 that does not have a uniform outer periphery. The bridge member 1501 has an outer peripheral portion that can include edges 1511, 1512, 1513, 1521, 1522, and 1523. The outer periphery of the bridge member may or may not be consistent or uniform with the top surface 1530. As shown in FIG. 74, the bridge member has bottoms 1541, 1542, 1543, and 1544 that can be used to releasably engage the inserter. The engagement between the bridge member geometry and the inserter allows the implant 1500 to be maintained in the first configuration.

76 and 77 show the implant embodiment 1800 of the invention with top-loading means of engaging means 1810 and 1830 for interaction with the means of insertion. The connecting means 1810 and 1830 have upper elements 1817 and 1831, respectively. The connecting means 1810 and 1820 can share the bottom element 1815, thereby forming independent spaces 1818 and 1832 for releasably engaging with the means of insertion. In an alternative embodiment, the connecting means 1810 and 1820 may share the bottom element 1815 and the top element, thereby forming at least one space for releasably engaging with the means of insertion. can.

78 and 79 show implant embodiment 2200 capable of having bone engaging members 2230 and 2235 integrated into the implant bridge 2210. The implant bridge 2210 has an upper surface 2211 and a lower surface 2212. Bone engaging members 2230 and 2235 can have feature portions 2220 that can improve bone purchase or pull strength of the implant 2200 from bone or soft tissue. The implant 2200 can have protrusions or other connecting means 2250 and 2260 for connecting with the means of insertion. The coupling means 2250 and 2260 have lower surfaces 2255 and 2265 that are releasably engaged with insertion means capable of allowing the inserter or other means of insertion to be side-loaded, top-loaded, or swivel-loaded, respectively. Can be done. The means of insertion can maintain the integrated implant in the first configuration, thereby allowing a second implant configuration when the implant is disassembled from the inserter. The means of insertion can utilize features similar to the 2250 and 2260 described herein in combination with other surfaces such as the top surface 2211. This combination of means of insertion can be used to maintain one or more features or arms or protrusions. This combination of means of insertion may be used to create bending modalities such as 3-point or 4-point bending to maintain a particular implant configuration or combination of configurations. A combination of a surface and a means of insertion such as 2250 may be used in the entire implant or in parts of the implant to create or maintain a particular configuration of the implant. For example, tabs such as 2250 and top surfaces such as 2211 may be used to maintain one side of the implant or one arm of the implant in a particular configuration. When disassembled, the arm may have a different or identical configuration than the rest of the implant.

The exemplary embodiments described herein are not intended to be limiting. The benefits of the present invention will be apparent to those skilled in the art. Further, those skilled in the art will appreciate that the intent of the invention may be realized in other embodiments not necessarily described herein.

Claims (20)

A system for osteosynthesis between the first and second bone elements,
Includes implants and inserters with members that engage the bone,
The implant comprises a bridge, first and second legs, as well as a first inserter engagement feature and a second inserter engagement feature.
The bridge, together with the first leg and the second leg, extends in the longitudinal direction between the first connection and the second connection, respectively, and the bridge faces the surface facing the bone and the bone. Has an upper surface opposite to the surface,
The first leg is vertically extended from the surface of the bridge facing the bone in the first connection.
The second leg extends vertically from the surface of the bridge facing the bone in the second connection.
The first inserter engagement feature portion extends from the first connection in a direction away from the second connection along the long axis direction .
The second inserter engagement feature portion extends from the second connection in a direction away from the first connection along the long axis direction .
The implant includes a free state and an elastically deformed state, in which the first leg and the second leg extend from the surface of the bridge facing the bone so that their free ends approach each other. However, in the elastically deformed state, the first leg portion and the second leg portion are parallel to each other.
The inserter can be detachably connected to the implant, the inserter comprising a feature that contacts the bridge and a first implant engagement feature and a second implant engagement feature.
When the inserter is connected to the implant in the elastically deformed state, the feature portion in contact with the bridge supports the upper surface of the bridge so as to maintain the implant in the elastically deformed state, and the first inserter engaging feature. The portion and the second inserter engagement feature portion are supported by the first implant engagement feature portion and the second implant engagement feature portion, respectively, and the inserter is such that the inserter is the first bone element and the second bone element. The inserter is coupled to the implant so that it faces the bone element and does not interfere with the final seating of the implant.
The inserter twists the inserter relative to the implant about an axis that is parallel to the elastically deformed first and second legs and perpendicular to the bridge. It can be removed from the implant and the engagement of the first implant engagement feature and the second implant engagement feature can be disengaged from the first inserter engagement feature and the second inserter engagement feature, respectively.
A system characterized in that the implant moves to the free state when the inserter is removed from the implant. The system according to claim 1, wherein the bridge has a uniform thickness between the first connection and the second connection. The system according to claim 1, wherein the bridge has a rectangular cross section defined by a surface of the bridge facing the bone and an upper surface thereof and front and back surfaces of the bridge. The rectangular cross section of the bridge is characterized in that the thickness between the front surface and the back surface of the bridge is wider than the thickness between the surface of the bridge facing the bone and the upper surface. The system according to claim 3. The system according to claim 1, wherein the first inserter engagement feature portion and the second inserter engagement feature portion each include a flat surface facing the bone. The bridge comprises a surface oriented to the bone and anterior and posterior extending between the superior surface and the first and second connections, respectively, the inserter has anterior and posterior surfaces, and the inserter is on the implant. The first aspect of the present invention is characterized in that, when connected, the front surface and the back surface of the inserter face in the same direction as the front surface and the back surface of the bridge, respectively, and the front surface and the back surface of the inserter are flat. The system described. The first implant engagement feature maintains a constant distance from the second implant engagement feature when the inserter is attached to the implant in an elastically deformed state and when the inserter is removed from the implant. The system according to claim 1, wherein the system is characterized by the above. The system of claim 7, wherein the inserter comprises a single component. A system for osteosynthesis between the first and second bone elements,
Includes implants and inserters with members that engage the bone,
The implant comprises a continuously flat anterior surface and a continuously flat posterior surface, the implant having a bridge, a first leg and a second leg, and a first inserter engagement protrusion and a second inserter engagement protrusion. The bridge, the first leg and the second leg, and the first inserter engagement protrusion and the second inserter engagement protrusion are provided by the front surface and the back surface of the implant of the implant. All defined,
The bridge extends longitudinally between the first and second ends, the bridge includes an upper surface and a surface facing the lower bone, and the bridge is the anterior surface and the posterior surface of the implant and said. It has a rectangular cross section defined by the upper surface of the bridge and the surface facing the bone.
The first leg extends perpendicularly from the surface of the bridge facing the bone at the first end of the bridge to form a first connection in which the first leg matches the bridge.
The second leg extends perpendicularly from the bone-facing surface of the bridge at the second end of the bridge to form a second connection in which the second leg matches the bridge.
The first inserter engaging protrusion extends from the first connection in a direction away from the second connection along the long axis direction .
The second inserter engaging protrusion extends from the second connection in a direction away from the first connection along the long axis direction .
The implant includes a free state and an elastically deformed state, in which the first leg and the second leg extend from the surface of the bridge facing the bone so that their free ends approach each other. However, in the elastically deformed state, the first leg portion and the second leg portion are parallel to each other.
The inserter can be detachably connected to the implant, the inserter comprising a feature portion in contact with the bridge and a first implant engagement shelf and a second implant engagement shelf.
When the inserter is connected to the implant in the elastically deformed state, the feature portion in contact with the bridge supports the upper surface of the bridge and the first inserter engaging protrusion so as to maintain the implant in the elastically deformed state. The portion and the second inserter engaging protrusion are supported by the first implant engaging shelf portion and the second implant engaging shelf portion, respectively, and the inserter is such that the inserter is the first bone element and the second bone element. The inserter is coupled to the implant so that it faces the bone element and does not interfere with the final seating of the implant.
The inserter twists the inserter relative to the implant about an axis that is parallel to the elastically deformed first and second legs and perpendicular to the bridge. It can be removed from the implant and the first implant engagement shelf and the second implant engagement shelf can be disengaged from the first inserter engagement protrusion and the second inserter engagement protrusion, respectively.
A system characterized in that the implant moves to the free state when the inserter is removed from the implant. 9. The system of claim 9, wherein the bridge has a uniform thickness between the first end and the second end. The rectangular cross section of the bridge is characterized in that the thickness between the front surface and the back surface of the bridge is wider than the thickness between the surface of the bridge facing the bone and the upper surface. The system according to claim 9. The system according to claim 9, wherein the first inserter engaging protrusion and the second inserter engaging protrusion each include a flat surface facing the bone. The inserter comprises a front surface and a back surface, and when the inserter is connected to the implant, the front surface and the back surface of the inserter face in the same direction as the front surface and the back surface of the bridge, respectively, and the front surface and the back surface of the inserter are oriented. The system according to claim 9, wherein the back surface is flat. Whether the inserter is connected to the implant in an elastically deformed state or the inserter is removed from the implant, the first implant engagement shelf is at a constant distance from the second implant engagement shelf. The system according to claim 9, wherein the system is kept. 14. The system of claim 14, wherein the inserter comprises a single component. A system for osteosynthesis between the first and second bone elements,
Includes implants and inserters with members that engage the bone,
The implant comprises a bridge, first and second legs, as well as a first inserter engagement protrusion and a second inserter engagement protrusion.
The bridge, together with the first leg and the second leg, extends in the longitudinal direction between the first connection and the second connection, respectively, and the bridge faces the surface facing the bone and the bone. Has an upper surface opposite to the surface,
The first leg is vertically extended from the surface of the bridge facing the bone in the first connection.
The second leg extends vertically from the surface of the bridge facing the bone in the second connection.
The first inserter engaging protrusion extends from the first connection in a direction away from the second connection along the long axis direction .
The second inserter engaging protrusion extends from the second connection in a direction away from the first connection along the long axis direction .
The implant includes a free state and an elastically deformed state, in which the first leg and the second leg extend from the surface of the bridge facing the bone so that their free ends approach each other. However, in the elastically deformed state, the first leg portion and the second leg portion are parallel to each other.
The inserter can be detachably connected to the implant, the inserter comprising a feature portion in contact with the bridge, and a first implant engagement pocket and a second implant engagement pocket, each having a flat surface.
When the inserter is connected to the implant in the elastically deformed state, the feature portion in contact with the bridge supports the upper surface of the bridge and the first inserter engaging protrusion so as to maintain the implant in the elastically deformed state. The portion and the second inserter engaging protrusion are supported by the first implant engaging pocket and the second implant engaging pocket, respectively, and the inserter is such that the inserter is the first bone element and the second bone element. The inserter is connected to the implant so that it faces the implant and does not interfere with the final seating of the implant.
The inserter twists the inserter relative to the implant about an axis that is parallel to the elastically deformed first and second legs and perpendicular to the bridge. It can be removed from the implant and the first implant engagement pocket and the second implant engagement pocket can be disengaged from the first inserter engagement protrusion and the second inserter engagement protrusion, respectively.
A system characterized in that the implant moves to the free state when the inserter is removed from the implant. The bridge has a uniform thickness between the first connection and the second connection, and the bridge is a surface of the bridge facing the bone and an upper surface thereof and an anterior surface and a back surface of the bridge. 16. The system of claim 16, characterized in that it has a rectangular cross section defined by. The rectangular cross section of the bridge is characterized in that the thickness between the front surface and the back surface of the bridge is wider than the thickness between the surface of the bridge facing the bone and the upper surface. The system according to claim 17. The bridge comprises a surface oriented to the bone and anterior and posterior extending between the superior surface and the first and second connections, respectively, the inserter has anterior and posterior surfaces, and the inserter is on the implant. 13. The system described. The first implant engagement pocket maintains a constant distance from the second implant engagement pocket when the inserter is elastically deformed and connected to the implant or when the inserter is removed from the implant. 16. The system of claim 16, wherein the inserter comprises a single component.

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