JP2017535301A - Bone implant with means for multidirectional forces - Google Patents

Abstract

A medical implant for osteosynthesis, wherein the implant has a first configuration when releasably attached to a delivery device and at least a second configuration when released from the delivery device. . The second configuration generates forces in more than one direction when the implant is implanted in more than one bone segment. The implant can have a second configuration and a third configuration, each configuration generating forces in the same or different directions. The implants can be adapted to compress, disperse and / or control the spatial orientation of the bone segments relative to each other. The implant can be packaged in a kit with tools that facilitate implant surgery.

Description

  The present invention is in the technical field of medical devices. More particularly, the present invention is in the technical field of bone fixation or joint fixation or deformation correction. The present invention relates to a fixation system for all types of bone. Such systems are used in osteosynthesis (bone fusion), where the implant bridges the fracture and generates a force across the bone member. Forces (eg, compression or dispersion) are generated by the properties of the implant and the different configuration / geometry of the implant. For example, the implant may have a first configuration for insertion / implantation and a second configuration or a third configuration required to generate / generate a specific force magnitude and vector. Is possible. It may be desirable for improved healing to provide force across most of the bone surface to be healed, not just in a particular area. Implants can be shown with respect to various bones throughout the skeleton. A “bone fixation device” or implant is a variety of devices that securely fix objects to bone, including but not limited to staples, bone plates, modular staples, bone screws, pins, blades, suture anchors, and the like. Either can be included.

  The present invention seeks to improve the problems of the prior art. The present invention creates a system that allows the use of an implant that can provide a force (eg, compressive force) uniformly across the bone to be healed. In addition, the present invention includes the instruments necessary for proper placement and function of the implant. The present invention includes an implant that provides a means for generating forces in more than one direction. The present invention also incorporates other necessary features required for final installation into the inserter and implant. For example, the inserter can be ready for drill holes, bone screws, etc. and / or can serve to position the implant at a particular location or position.

  The present invention includes implants and means for insertion and / or manipulation. The implant can be a bone staple, bone plate, modular staple, or the like. Implants are elastic properties or other material properties that allow the device to have more than one configuration, or can be configured to various locations when placed on or in bone. It is possible to have a geometric shape. The implant provides one or more forces (eg, compression or dispersion) across two or more bone segments. The inserter or delivery device holds the implant in a configuration that is different from the implanted or final configuration. The terms “fastening device” and “implant” may be used interchangeably in this application and are not intended to be limiting in nature, and are intended to be “inserter”, “insertion device”, and The term “delivery device” is also used interchangeably in this application and is not intended to be limiting in nature.

  The implants of the present invention can be constructed from elastic materials, such as Nitinol, or materials that allow the implant to have multiple configurations. The ability of an implant to have multiple configurations can be the result of material properties having shape memory properties or elastic properties, or it can be the mechanical (physical, physical, It can be the result of an operation (chemical, thermal, electrical, or other). The implant has features for engaging bone. These features can include bone screws, leg members, or other features for attaching the implant to the bone. The implant may have a feature for engaging an inserter or delivery device as an instrument for implantation. The implant maintains a first configuration for insertion, a second configuration for generating a force magnitude and vector in one direction, and a first force generated by the second configuration. A third arrangement for generating force magnitudes and vectors in the same direction or in the second direction. The implant can also have a second configuration that generates force or compression simultaneously in one or more directions. The implant can be attached to the insertion device to allow the user to determine the order and / or timing of providing the force in one or more directions. The insertion device can have one or more features that allow the use of drills, screws, drivers, depth gauges, etc. while attached to the implant. The inserter can have one or more features that allow bone preparation for the implant with the implant attached to the inserter. The insertion device has a feature for engaging the implant, which can maintain the implant in multiple configurations. For example, the insertion device can maintain the implant in a first configuration, a second configuration, or a third configuration, or a combination of configurations. When the insertion device is removed, the implant is allowed to take a second configuration, a third configuration, or an additional configuration. The inserter can be used to manipulate the implant into the second or third configuration or additional configurations. The implant can take a second or third configuration or an additional configuration while still being attached to the insertion device.

  An implant can have multiple configurations, for example, one configuration for insertion into bone and the spatial orientation of one or more bone segments can be compressed and distracted. Or at least a second configuration for controlling and the like, and a third configuration capable of generating a force in the same direction as the second configuration or in a different direction. The generated force can be used to compress, distribute, or control the spatial orientation of one or more bone segments. With respect to the exemplary embodiments described herein, compressive force can be used for discussion, but it should not be considered limiting. There are other uses for the present invention that may require forces other than compressive forces. The implant can have one or more bridge members in various configurations. The implant can have a protruding member for engaging the bone. The implant can have a modular member for engaging the bone, such as a bone screw or peg. Based on the description of the invention herein, it will be apparent to those skilled in the art that there are multiple options for connecting the implant to the bone. The connecting member or connecting feature need not be of the same material as the bridge component. The ability of the present invention to generate one or more forces in the same or different directions is the movement of a bridge member, connection member, or other member of an implant or fixation device, or different members or features of an implant. It can result from the movement of the combination.

  The summary of the present invention discusses the advantages of the present invention in terms of an implantable device for generating spatial orientation compression, dispersion, or control. The advantages of the present invention can also be applied to embodiments of the present invention in external or non-implantable embodiments. The use of the present invention is not simply limited to implantable embodiments.

1 is a perspective view of a first embodiment of the present invention showing an implant with a bone screw that generates compression by two different actions as indicated by arrows. FIG. 1 is a perspective view of a first embodiment of the present invention showing an implant without a bone screw that generates compression by two different actions. FIG. It is a top view of the 1st embodiment of the present invention, and shows the implant of the 1st composition in the state where the bone screw is not inserted, and is a figure showing that compressive force is not generated. It is a top view of the 1st embodiment of the present invention, and shows the implant of the 2nd composition in the state without a bone screw, and is a figure showing that the 1st compressive force is generated. FIG. 2 is a top view of the first embodiment of the present invention, showing a third configuration of the implant without a bone screw, wherein a second compressive force is generated while maintaining the first compressive force. FIG. It is a perspective view of the 1st embodiment of the present invention, and shows the implant of the 1st composition in the state where the bone screw is not inserted, and is a figure showing that compressive force is not generated. FIG. 3 is a perspective view of the first embodiment of the present invention, showing the second configuration of the implant with the bone screw inserted, wherein the first compressive force is generated by convergence of the bone screw. FIG. FIG. 4 is a perspective view of the first embodiment of the present invention, showing the third configuration of the implant with the bone screw inserted, while maintaining the first compressive force and the second compressive force It is a figure which shows that is generated by the displacement of a bridge member. FIG. 2 is a front view of a first embodiment of the implant of the present invention, showing attachment to the device for insertion and to maintain the first configuration of the implant. FIG. 2 is a bottom view of a first embodiment of the implant of the present invention, showing attachment to the device for insertion and to maintain the first configuration of the implant. FIG. 5B is a top perspective view of FIG. 5A. FIG. 5B is a bottom perspective view of the first embodiment of FIG. 5A. FIG. 3 is a perspective view of a first embodiment of an implant attached to an insertion / retention device, shown with a bone screw inserted, and prior to generation of a first compressive force. FIG. 3 is a perspective view of a first embodiment of an implant attached to an insertion / retention device, shown with the bone screw inserted, as a result of allowing the bone screw to converge, FIG. 2 is a diagram after the generation of the first compression force, but before the generation of the second compression force. FIG. 3 is a perspective view of a first embodiment of an implant attached to an insertion / retention device, shown with the bone screw inserted, as a result of allowing the bone screw to converge, FIG. 4 is a view after a compressive force of 1 is generated and, as a result of allowing the ends of the implant to move closer together, as a result of a second compressive force being generated, the bridge portion of the implant It is a figure which shows generating 2nd compressive force in. FIG. 3 is a top view of an implant kit that may be provided for inserting an implant of the present invention into a bone segment. FIG. 6 is a side view of one embodiment of the present invention at one possible location on a foot bone. FIG. 9B is a close-up view of FIG. 9A showing one embodiment of the present invention at one possible location on the foot bone. FIG. 9B is a top view of the foot shown in FIGS. 9A and 9B, showing a cross-section of one embodiment of the present invention at one possible location on the foot bone. FIG. 6 is a top view of a second embodiment of the present invention showing an implant comprising means for attaching to instruments and means for attaching to one or more bone engaging means. FIG. 12 is a side view of the second embodiment of FIG. 11 showing regions and / or features for controlling force in at least one direction. It is a perspective view of 2nd Embodiment shown by FIG. 11 and FIG. FIG. 6 is a top view of a third embodiment of the present invention showing an implant with integral bone engaging means. FIG. 15 is a side view of the third embodiment of FIG. 14 showing regions and / or features for controlling force in at least one direction. FIG. 10 is a perspective exploded view of a fourth embodiment of the present invention showing an implant comprising bone engaging means and at least one means for attaching at least one integral bone engaging means. FIG. 10 is a perspective assembly view of a fourth embodiment of the present invention showing an implant comprising bone engaging means and at least one means for attaching at least one integral bone engaging means.

  The present invention includes an implant for generating multi-directional or multi-component forces across bone or tissue segments. Exemplary embodiments of the present invention are shown in the drawings and discussed below. The implant can be of a configuration similar to a modular staple or bone plate as discussed in the figures. The present invention can use an apparatus or instrument for inserting an implant that can be pre-assembled or added to the implant, as shown in FIGS. One or more implants may be held in a particular configuration during packaging, which facilitates engagement with the inserter in use. Certain embodiments of the invention may not require the use of inserter tools, for example, embodiments made from shape memory nitinol will depend on the user's ability to activate shape memory nitinol, It is possible to generate multi-directional forces or multi-component forces.

  The implant embodiments described herein connect to any type of inserter or fixation device having two or more implant configurations in which a force (typically compressive force) is generated across the bone segment. Which can be used, including but not limited to various bone staples, bone plates and the like.

  1 and 2 show an implant 200. FIG. 1 shows a bone screw 100 assembled to an implant 200. The implant 200 is shown with the forces shown in directions 300 and 310. In this exemplary embodiment, the implant 200 has a screw hole 230 for attaching the bone screw 100 or other fixation element. In another embodiment, the implant can have an integral staple leg, which can be used in place of the screw hole 230 or in combination with the screw hole 230. (See, for example, FIGS. 15-17.) Also shown is a tab 240, which can have a slot 250 to facilitate attachment to an insertion device. This mounting tab 240 can be used to hold the implant 200 with the flexion region 220 in the neutral position, i.e., the screw hole 230 is held in a flat orientation. The implant 200 has a bending region 220, and the bending region 220 is positioned between the screw hole 230 and the bridge member 210. This bend area 220 is an asymmetric strategically placed to help control the direction, force, and predictability of the bend area 220, such as cutouts, slots, embossments, ridges, etc. It can have geometric shapes or other features. In this embodiment, the bridge member 210 and the bent region 220 define a space 215. Forces can be generated simultaneously or as separate actions. In the exemplary embodiment, the force is generated as a separate action, which will simplify the description herein. The first compressive force 300 may be generated when the bending region 220 is allowed to move, thereby allowing the screw hole 230 and the bone screw 100 to converge relative to each other. The compressive force 300 can be generated by having a super-elastic implant with a screw hole region 230 that is manufactured such that they converge relative to each other when the implants are stationary. Keeping the screw hole region 230 flat can store compressive (ie, convergent) energy until they are released and allowed to recover the focused orientation. With the bone screw region 230 held flat or relatively parallel to the bone, the bone screws 100 can be inserted into the bone and maintained parallel to each other. When the bone screw is fully seated, the screw holes 230 may be released from their flat orientation and allowed to recover their convergent orientation due to the superelastic aspect of Nitinol. In another embodiment, this same effect can be realized by the shape memory aspect of the nitinol material. In such embodiments, when the bone screw is fully seated in the bone plate 200, the screw hole 230 is activated using, for example, a suitable activation temperature (eg, body temperature or an external temperature source). And due to the shape memory aspect of Nitinol, it is possible to restore their convergent orientation. The magnitude of the force 300 may depend on the material selected, the overall geometry of the implant, and / or the surgical procedure. This compressive force 300 can generate a compressive force having a greater magnitude at the level of the tip of the screw 100 than at the level of the bone plate 225. A compression force 310 can be generated when the bridge member 210 is allowed to displace to the open position, in this case outward. This displacement can change the shape of the space 215, thereby generating a force 310 that brings the screw holes 230 closer together and the plate 225 than the level of the tip of the bone screw 100. It is possible to generate a compressive force that can have a large magnitude at the level of.

  Similar to the mechanism that can be used to generate the force 300, the force 310 can be generated by having a superelastic implant with a bridge member 210, which is used when they are stationary. Manufactured to be in the outward or open position. Holding the bridge members 210 in the closed position is capable of storing compressive (ie, displacement) energy until they are released and allowed to recover the open position or outward orientation. With the bone screw 100 fully seated and firmly secured in the bone, the bridge members 210 are released from their closed orientation and their open due to the superelastic aspect of Nitinol. It may be possible to restore the orientation. This movement from the closed position to the open position can produce a relative spatial change between the bone screws 100, thereby producing a displacement that can result in a compressive force 310. In another embodiment, this same effect can be realized by the shape memory aspect of the nitinol material. In such embodiments, once the bone screw is fully seated in the bone plate 200, the bridge member 210 can be activated using a suitable activation temperature (eg, body temperature or an external temperature source). Also, due to the shape memory aspect of Nitinol, it is possible to restore their open position or outward orientation. The magnitude of the force 310 may depend on the selected material, the overall geometry of the implant (eg, thickness, width, height, etc.), and / or surgical technique. The unique combination of forces 300 and 310 can produce a more uniform and overall compressive force than when the forces are individual. The current state of the art is to have an implant device that will only generate one compressive force. The description of compression forces 300 and 310 is not intended to be limiting. The force generated may or may not be uniform or may have a varying magnitude. Also, the specific order of the generated forces is not limited. The present invention also includes any order or combination of two or more force magnitudes and vectors.

  FIG. 2 shows the implant 200 under the same conditions as FIG. 1 except that the bone screw 100 is not in place. This figure shows a screw hole 230, which in this particular embodiment is a locking screw hole. This embodiment has two bridge members 210 that create a space 215. Based on the description of the invention herein, one of ordinary skill in the art will understand that there are numerous shapes that can be created by the bridge member. Moreover, it is possible to have an implant 200 that can have multiple bridge members or a single bridge member. The single bridging member can be manipulated so that the securing means (i.e. bone screws, staple legs, etc.) can in this case be approximated to produce a compressive force. In the case of a single bridge member, the space 215 may or may not be present.

  The positioning and / or orientation and / or geometry of the opening 215 relative to the bridge member 210 and the bending region 220 is for distributing the stress required in the implant 200 to achieve the desired compressive force. Means can be provided. The position and geometry of the opening 215 can be varied within the scope of the present invention to manipulate the stress distribution and achieve the desired performance. Within the scope of the present invention, the position and geometry of the opening 215 can be changed in combination with the thickness 205 to manipulate the stress distribution and achieve the desired performance. The desired amount of force generated by the present invention can be achieved by manipulating the individual aspects of the implant geometry and their relative orientation with respect to each other. The geometry and relative orientation of the thickness 205 can be changed to manipulate the stress distribution in the implant bridge 210 to achieve the desired performance. The geometry and relative orientation of the thickness 205 is modified in combination with changing the geometry and relative orientation of the flexure region 220 to manipulate the stress distribution in the implant 200 to achieve the desired performance. Or the generated force can be realized. The geometry and relative orientation of the thickness 205 can be changed in combination with changing the geometry and relative orientation of the bent region 220, and the geometry and relative orientation of the opening 215 In combination with changing the orientation, it is possible to manipulate the stress distribution in the implant 200 to achieve the desired performance. Moreover, the implant widths 208, 209, 211, 212, 213, and / or 214 as shown in FIG. 3A may be independent variables or one or more of the previously described implants. In combination with aspects, the geometry and / or orientation can be manipulated to manipulate the stress distribution in the implant 200 to achieve the desired performance or force generation.

  FIG. 3A shows a top view of the implant 200 for this particular embodiment. The implant 200 is shown as it will be retained before releasing and / or activating either the superelastic mechanism and / or the shape memory mechanism, i.e. in this case it is The inserter is not shown in this particular figure for clarity and is shown with no force generated when it can be held in the inserter for implantation. For clarity, the fixation means bone screw 100 is not included in FIG. 3A, FIG. 3B, or FIG. 3C. The implant 200 can have tabs 240 or other means for holding the implant in a flat geometry that does not generate forces. This particular embodiment shows the attachment means 230 as a locking hole for the bone screw 100. However, based on the description of the invention herein, one of ordinary skill in the art will be able to integrate the securing means with the implant 200 (e.g., a staple leg), or a peg, blade, Alternatively, it will be understood that other securing means may be included, such as other types of bone screws and the like. The bend region 220 may or may not be of uniform width and / or thickness. Bending region 220 and / or bridge member 210 have certain features, such as holes, slots, keyways, ribs, bosses, etc., to facilitate and support predictable means and methods of bending. Is possible. Space 215 is adjacent to bridge member 210 having widths 211 and 212. The width of the bridge member 210 may or may not be uniform. The width 211 may be larger or smaller than the width 212. Bridge member widths 209 and 210 and widths 213 and 214 may or may not be the same. The width of some bridge members can be the same, while the width of other bridge members can be larger or smaller than the remaining width. Although this embodiment can be made from Nitinol or other materials having shape memory or superelastic material properties, other materials can also achieve the same effect.

  FIG. 3B is a top view of the second configuration of implant 200 showing a first compressive force 300. The compressive force 300 may be in a direction that causes the bent region 220 and / or the securing means (eg, bone screw 100 or other such securing means, etc.) to converge (ie, the distal end of the bone screw 100 is brought closer). FIG. 3C is a top view of the third configuration of the implant 300, showing the second compressive force 310 and the first compressive force 300. While the overall width 400 of the implant 200 has decreased, the distance 216 between the bridge members 210 has increased. In alternative embodiments, the distance 216 can be increased or decreased as necessary to generate a particular force. The compressive force 310 may be in a direction that reduces the distance between the bend region 220 and / or the securing means (eg, bone screw 100 or other such means). The order in which the implants generate the various forces may not be important. In this exemplary embodiment, force 300 is generated before force 310. The opposite is also possible. Similarly, the relative magnitude of the force generated is not inherently limiting. One force may be greater or less than the other force generated. As previously described herein, the relative magnitude and direction of the generated force or forces depends on the orientation of the implant, the material or combination of materials used in the structure, the implant The various feature geometries and / or surgical procedures may depend. Also, the relative magnitude and direction of the generated force or forces can be generated by the superelastic and / or shape memory properties of a material such as Nitinol. The superelastic and / or shape memory properties of the material are stored in one configuration when the implant is allowed to recover or attempt to recover its resting or zero stress configuration It will be possible to allow the energy that will be just released. One embodiment of the present invention can combine the use of the superelastic and shape memory properties of Nitinol material. For example, one force can be generated using superelastic properties and the second force can be generated using shape memory properties. In this embodiment, both the first force 300 and the second force 310 remain in the final state or final configuration of the implant.

  FIG. 4A shows a perspective view of the implant 200 for this particular embodiment. The implant 200 is shown as being held before releasing and / or activating either the superelastic mechanism and / or the shape memory mechanism, ie, in this case, for example, When it can be held in or by the inserter for implantation, it is shown without any force being generated, and for clarity, the inserter is not shown in this particular figure . For clarity, the fixing means bone screw 100 is not included in FIG. 4A. FIG. 4B is a perspective view of the implant 200 shown with bone fixation means, bone screw 100. The implant 200 and the bone screw 100 are shown with a force 300 that results in the bone screw 100 converging with respect to each other and generating a compressive force. One securing means may converge more or less than another, or one or more may not converge at all. The force 300 generates net convergence, which may or may not be equally distributed among the fixed means. In some embodiments, more than two securing means may be utilized. This can be a bone screw, staple leg, peg, blade, or some combination thereof. It may be desirable to converge some or all of the securing means. Certain fixation members can be moved in specific directions, while others may or may not move in alternative directions.

  FIG. 4B is a perspective view of the second configuration of the implant 200 showing the first compressive force 300. The compressive force 300 may be in a direction that causes convergence of the bent region 220 and / or the securing means (eg, bone screw 100 or other such securing means).

  FIG. 4C is a top view of the third configuration of implant 200, showing a second compressive force 310 and a first compressive force 300. While the overall width 400 of the implant 200 has decreased, the distance 216 between the bridge members 210 has increased. In alternative embodiments, the distance 216 can be increased or decreased as necessary to generate a particular force. As previously described, the force 310 may be in a direction that reduces the distance between the bend region 220 and / or the securing means (eg, bone screw 100 or other such means). The order in which the implants generate the various forces may not be important. In this exemplary embodiment, force 300 is generated before force 310. The opposite is also possible. Similarly, the relative magnitude of the force generated is not inherently limiting. One force may be greater or less than the other force generated. In this embodiment, both the first force 300 and the second force 310 remain in the final state or final configuration of the implant.

  FIG. 5A is a front view of the implant 200 assembled to the inserter 500. FIG. 5 a shows the implant 200 assembled to the inserter 500. The inserter 500 can have an upper portion 510 and a base 520. The inserter 500 is releasably engaged with the implant 200. The inserter 500 has means 540 that are attached to the implant tab 240 in the slot 250 to maintain the implant 200 in a flat configuration. The inserter 500 has means 550 for engaging the implant 200 to maintain the distance 216 closed.

  FIG. 5B is a bottom view illustrating the implant 200 releasably attached to the inserter 500. The inserter base 520 has attachment means 540 that engages a slot 250 in the implant attachment means 240. In this embodiment, the inserter engagement means 540 can be withdrawn from a slot 250 (not shown) in the implant attachment means 240 when the inserter 500 is rotated in the view shown. When released, the superelastic properties of the implant 200 will allow the bending region 220 of the implant 200 to move toward their zero stress condition, or in other words, the region of the implant 200. 220 will be able to bend, which can converge the bone screw hole 230 and the attached bone screw 100 (not shown). This action can generate a compression force 300. As further shown, the inserter base 520 has retractable means 550 that maintains the implant bridge portions 210 in their closed or loaded configuration. It is possible. In this embodiment, when the attachment means 550 is retracted or released from the implant bridge member 210, the superelastic properties allow the bridge member 210 to open or move to their outward configuration. To do. This action can cause the screw holes 230 to move relatively close to each other, thereby generating a compressive force 310. The order in which the implants are released from the inserter device is not limited. The attachment means 550 can be released first, which can cause the implant bridge member 210 to open or move to their outward configuration. This action can cause the screw holes 230 to move relatively close to each other, thereby generating a displacement. This displacement can shorten the overall length 400 of the implant 200. This shortening can be large enough to pull the inserter attachment means 540 from the slot 250 of the implant attachment means 240, which is inserted from the slot 250 of the implant attachment means 240. It is possible to eliminate the need to rotate the inserter 500 so that it is released.

  FIG. 6A is a top perspective view of the implant 200 assembled to the inserter 500. The inserter 500 can have an upper portion 510 and a base 520. The inserter 500 is releasably engaged with the implant 200. The inserter 500 has means 540 that are attached to the implant tab 240 in the slot 250 to maintain the implant 200 in a flat configuration. The inserter 500 has means 550 for engaging the implant 200 to maintain the distance 216 closed. FIG. 6B is a bottom perspective view further illustrating one possible embodiment of the inserter 500 attached to the implant 200. This figure shows the inserter attachment means 550, which is engaged with the implant bridge portion 210 and maintains them in the first configuration or closed state. Also shown in FIG. 6B is an inserter attachment means 540 that is slidably engaged within a slot 250 of the implant attachment means 240 and includes a region 220 and a bone screw hole 230. It is possible to maintain a flat orientation or configuration. Based on the description of the invention herein, there are a number of mechanisms and embodiments for releasably attaching to an implant, wherein the loaded state and / or stress can be reduced before releasing the implant. It will be clear to the person skilled in the art that it is possible to maintain the implant in the received state and / or to realize a state in which the implant generates forces. FIG. 6A shows a hole 530 that allows insertion of bone screw 100 or other securing means.

  FIG. 7A is a perspective view of the inserter 500 releasably attached to the implant 200 and shown with the bone screw 100 in place. As shown, the inserter 500 maintains the implant in a neutral state, and the fixation means, the bone screw 100, is in a parallel configuration that does not generate force. FIG. 7B shows the inserter 500 being released from the implant 200 by a twisting action 600. This action 600 releases the engagement means 540 from the implant attachment tab 240 while maintaining the attachment means 550 on the implant. When the engagement means 540 releases the implant, the bending region 220 is allowed to bend, thereby generating a force 300. In this particular exemplary embodiment, force 300 causes bone screw 100 to converge, thereby generating a compressive force across the bone segment. FIG. 7B illustrates the implant 200 and the inserter 500 before fully releasing the implant 200 from the inserter 500. FIG. 7C is a perspective view of a first embodiment of the implant 200 removed from the insertion / retention device 500. The first release action 600 has already been completed and, as shown, the second release action 610 is used to completely release the inserter 500 from the implant 200, thereby causing the bridge member 210. Can move and increase the distance 216 and bring the bone anchoring means 100 closer together, which reduces the overall width 400 of the implant and results in a force 310. Release action 610 may allow inserter attachment means 550 to be retracted in inserter base 520. In this particular exemplary embodiment, force 310 is an additional compressive force that further compresses the bone segment.

  The foregoing description relates to particular embodiments that are believed to be manufactured from materials having elastic properties, such as superelastic nitinol and the like. However, this description is not intended to be limiting in nature. One skilled in the art will understand based on the description of the invention herein that the same can be achieved using materials having, for example, shape memory aspects, such as shape memory nitinol and the like. . Other materials that have desirable material properties that will achieve the intended function of the present invention currently exist or may exist. Still other embodiments of the present invention can provide more than one force generated simultaneously, as opposed to a stepped manner as described herein. Also, the order in which forces are generated is not intended to be limiting in nature. The use of the inserter / holding device may or may not be optional. The specific details of the inserter can vary greatly depending on the embodiment chosen. The exemplary embodiments described herein describe two force configurations in detail. Based on the description of the invention herein, it will be apparent to those skilled in the art that multiple forces may or may not be beneficial depending on the intended use. You will find out. They will also find that it is clear that the magnitude and direction of the resulting force vector may or may not be equal or additional. It may be beneficial to generate multiple forces to produce a more uniform and predictable force than is currently available in prior art devices. Furthermore, the exemplary embodiments described herein contemplate designs with two securing means or bone screws. Other embodiments may be of the same style (eg, bone screws, bone pegs, blades, staple legs, etc.) or of various styles, or some combination thereof, two or more securing means Can be included. With regard to fixation means that are modular in nature, they may or may not be made of the same material as the implants described herein.

  Referring to FIG. 8, the implants of the present invention can be packaged as an implant kit with associated equipment required for successful implantation. This type of kit can be provided as a sterile single use kit for efficiency and cost efficiency. Such a kit includes one or more implants, a bone screw or other means for securing the plate to the bone, and a drill or reamer necessary to prepare the bone to receive the implant and bone screw; It may include any necessary drill guides and drivers and an inserter to facilitate implantation of the implant into the bone. FIG. 8 illustrates one embodiment of an implant kit 1000 that is used to provide the end user with the implant and associated equipment necessary to successfully implant the implant of the present invention. Can be done. Such a kit can include one or more implants 1100 similar to the embodiments described herein that are pre-assembled into the inserter 1150. The kit can also include bone screws 1125 of various lengths and / or diameters, a drill 1200, a drill guide 1300, a driver 1250, and a temporary fixation pin 1400. The kit can also include an insertion tool or inserter 1150 to facilitate insertion of the implant 1100 into the bone segment. One embodiment of the kit can have an implant 1100 pre-assembled on the insertion tool 1150. The kit may be assembled in tray 1500. When the end user opens the kit, the surgical procedure can include the following steps. After exposing the surgical site, the osteotomy or fracture can be reduced and held in place. A drill guide or reamer guide can be placed across the fusion site against the bone using both guide tubes. The first hole is drilled to the final depth by advancing the drill or reamer to a predetermined depth or until the depth stop hits the top of the guide. Temporary fixing pins can be installed in the prepared holes to help maintain the reduction while additional holes are being prepared. Another option may allow the holes to be prepared directly by the inserter 1150, eliminating the need for an auxiliary drill guide. This step of preparing the bone may involve the need or use of a depth gauge to select an appropriately sized bone screw. Once the hole is prepared, the implant 1100 can be secured to the bone by the bone screw 1125. A bone screw 1125 may be inserted through the implant and into the bone segment. The implant 1100 can be pre-assembled or mounted on the inserter tool 1150. Implant 1100 and bone screw 1125 should be fully inserted until they are flush with the bone surface. The implant is then released from the inserter tool, thereby generating a predetermined force and generating compression across the bone segment. Once the implantation is complete, the inserter and the remaining instruments can be discarded or recycled.

  FIGS. 9A and 9B illustrate one embodiment of the present invention 1800 in one possible location on the bone of a foot 1850 that can be positioned according to the techniques described herein. Yes. FIG. 9A illustrates a side view of the foot 1850 with the implant 1800 spanning the joint line or fracture line 1851. Implant 1800 can be fastened to bones 1855 and 1856 by bone screw 1810. FIG. 9B is a close-up view of bones 1855 and 1856, illustrating implant 1800 spanning a joint line or fracture line 1851. FIG. Implant 1800 can be fastened to bones 1855 and 1856 by bone screw 1810. In this exemplary embodiment, the implant 1800 can have a bridge member 1821 in an open configuration, which can cause shortening or displacement between the relative positions of the bone screw 1810. It is possible to place two bones 1855 and 1856 in parallel for possible healing of the joint line or fracture line 1851. The figure further shows a bent region 1820 of the implant 1800 in a bent position, which places the bone screws 1810 in a position that converges with respect to each other, and in some cases, possible healing of the joint line or fracture line 1851 Because of this, bones 1855 and 1856 can be placed further in parallel. FIG. 10 is a top view of foot 1850 and bones 1855 and 1856. This figure shows the flexion region 1820 of the implant 1800 in a flexed position, which places the bone screws 1810 in a position that converges with respect to each other, thereby possibly allowing a joint line or fracture line 1851 to coalesce. Because of this, bones 1855 and 1856 can be placed further in parallel.

  FIG. 11 shows a top view of a second embodiment of the present invention (implant 2000) having an upper surface 2041 and a space 2040. FIG. 11, 12 and 13 show an implant 2000 in a flat configuration. Space 2040 is defined by bridge member 2042 and bend region 2055. As previously described herein, the shape of the space 2040 can be changed by either contracting or expanding to generate a predetermined direction of movement or force. The implant 2000 has means 2030 for engaging various types of bone fixation means. For example, means 2030 may include non-locking holes, threaded locking holes, interference holes, tapered holes, or other mechanical means for connecting to bone engaging means (eg, pegs). , Screw, blade, etc.). The implant 2000 can have one or more means 2020 for engaging the means of insertion, as previously described herein. The implant 2000 may have means 2010 for engaging or indexing the implant by an inserter, driver, or other means of insertion or retention. The means 2010 can also be used to change the shape of the space 2040. In this embodiment, the means 2010 can be used to compress the space 2040, thereby generating a force that will keep the means 2030 away from each other. This configuration can be maintained while the bone anchoring means is inserted into the bone. When the implant 2000 is added to the bone by the bone anchoring means, the means for keeping the means 2010 apart is released, thereby allowing the distance between the means 2030 to be shortened and generating a compressive force. Is possible. FIGS. 12 and 13 show an implant 2000 having a top surface 2041 and a bottom surface 2045. The bottom surface 2045 can be interrupted by means 2050. The means 2050 is positioned to provide a predetermined bending region for predictably controlling the operation and / or direction of an alternative action or configuration of the implant 2000. In this particular embodiment, the means 2050 is shown as being positioned between the space 2040 and the bone anchoring means 2030, but may control the direction and operation of the first or second configuration. It can be positioned anywhere on the implant as desired.

  14 and 15 illustrate a third embodiment of the present invention (implant 2100) having a top surface 2105 and a bottom surface 2106. FIG. FIG. 15 shows the implant 2100 in a closed or compressed state. The implant 2100 has a space 2140 that can be defined by a bridge member 2142 and a bend region 2120. As previously described herein, the shape of the space 2140 can be changed by either shrinking or expanding to generate a predetermined direction of movement or force. The implant 2100 has means 2150 for engaging bone or other tissue. Means 2150 is integral with implant 2100. The securing means 2150 can be a variety of geometric shapes. For example, the means 2150 can be circular, rectangular, square, or other cross-sectional geometry. The means 2150 may be uniform in shape throughout the feature, may be tapered, or may have grooves, ridges, teeth, and the like. The implant 2100 is positioned to provide a predetermined region for engaging the means of insertion and / or for predictably controlling the operation and / or direction of the second action or configuration of the implant 2100. It is possible to have one or more means 2155 for generating a bent region. In this particular embodiment, the means 2155 is shown as being positioned between the space 2140 and the bone anchoring means 2150, although the first configuration and / or the second configuration and / or other It may be positioned anywhere on the implant where it is desirable to control the direction and / or movement of the alternative configuration. In this particular embodiment, the means 2155 serves as a connection point for an inserter, holder, driver or other instrument and / or the first implant configuration and / or the second implant configuration and It is possible to perform a combination of functions that may include serving as a predetermined area for controlling the direction and / or operation of other alternative configurations. Implant 2100 may or may not have means similar to previously described means 2010 for engaging or indexing the implant by an inserter, driver, or other means of insertion or retention. Also good. As previously described herein, the space 2140 can compress or expand, thereby generating a force that will maintain the means 2150 apart. This configuration may be maintained while being held in the second configuration for insertion into the implant bone. For example, the means 2150 can be held parallel to one another while the space 2140 is compressed. Maintaining the implant 2100 in these multiple configurations prior to insertion will maintain the means 2150 in parallel and at a fixed separation distance. Once implanted, the space 2140 is allowed to change or expand, thereby reducing the distance between the securing means 2150 and generating compressing forces and / or actions. Once implanted, the engagement means 2150 can no longer remain parallel and can be allowed to recover a compressed or closed configuration. Bending regions 2120 and 2155 can be allowed to return to a closed and / or converged state, thereby creating an alternative configuration that will generate compression.

  FIGS. 16 and 17 show a fourth embodiment of an implant 2200, which combines means 2230 for connecting to bone engaging means 2210 with integral bone engaging means 2250. FIG. FIG. 16 is an exploded view of the structure when the bone engaging means 2210 is a typical bone screw, but the bone engaging means 2210 can also be a peg, blade, non-locking screw, locking screw, etc. It is. The integral bone anchoring means 2250 is shown as a square cross-section, similar to a typical staple leg, but can be of any shape or configuration as previously described herein. It is. FIG. 17 shows the assembled structure in a closed or compressed configuration.

  Based on the description contained herein, it will become apparent to one skilled in the art that the present invention is not limited by the exemplary application. The present invention can have various embodiments of various sizes, and various combinations, shapes, and configurations are possible for various applications. For example, the implant can have one or more integral bone engaging means in combination with one or more means for connecting to the bone engaging feature. In addition, although the embodiments described herein are shown with two means for connecting to a bone engagement device, based on the description contained herein, It will be apparent to those skilled in the art that various combinations and / or numbers of means for connecting to the combined features are within the scope of the present invention. Moreover, the implant can be made of a material that can have elastic or spring properties that allow the implant to have more than one configuration. The present invention may or may not be realized by the inherent material properties of the implant material. The implant can achieve this alternative configuration, for example, by transitioning from the first configuration to the second configuration to the third configuration. Here, the first configuration can be that when attached to the inserter or delivery device, and the second configuration can be a configuration that generates a first force. The third configuration may be a configuration that generates a second force, which may or may not be of the same magnitude and / or direction as the first force. Good. The embodiments described herein are not intended to be limiting. The transition from one configuration to another configuration or configurations can be one separate transition or two or more separate transitions, and can be accomplished by one of ordinary skill in the art based on the disclosure herein. As will become apparent, there can be multiple forces of the same or different magnitude and direction. The transition can be due to inherent material properties, or can be achieved by manipulation of materials or combinations thereof.

  The embodiments described herein can be manufactured from a number of different materials or combinations of materials. For example, Nitinol can provide unique properties that allow embodiments to have multiple configurations with or without external mechanical manipulation, such as shape memory and / or superelasticity, etc. Has material properties. Also, other other materials, such as PEEK or other polymers, may have material properties that are beneficial to the embodiments described herein. Also, a combination of materials may be suitable. For example, a Nitinol plate with titanium or PEEK screw can be a selective material for some embodiments. Based on the description of the invention herein, one of ordinary skill in the art will be aware of typical materials and combinations of materials applicable to the invention, as well as when it can be related to superelastic nitinol or shape memory nitinol, etc You will know the mechanism of action of the present invention.

  The exemplary embodiments described herein are not intended to be limiting. Based on the description of the invention herein, the benefits of the invention will be apparent to those skilled in the art. Moreover, based on the description of the invention herein, those skilled in the art will recognize that the intent of the invention may be realized in other embodiments, not necessarily as described herein. You will understand.

Claims (17)

An implant for osteosynthesis comprising means of fixation to a bone or tissue segment,
A first configuration when releasably attached to the delivery device, and at least a second configuration when not attached to the delivery device, the second configuration comprising: An implant that generates forces in more than one direction when implanted in or on more than one bone or tissue segment. An implant for osteosynthesis comprising means of fixation to a bone or tissue segment,
A first configuration when releasably attached to the delivery device, and a second configuration and a third configuration when not attached to the delivery device, the second configuration comprising: Generating a force in a first direction when the implant is implanted in or on two or more bone or tissue segments, and the third configuration comprises the first direction of the first direction. An implant characterized by generating a force in the same direction or a second direction while maintaining the force.   The implant according to claim 1 or 2, further comprising means for releasably engaging the delivery device.   Implant according to claim 1 or 2, characterized in that it comprises bone plates, staples or modular staples.   The means for securing to a bone segment comprises a projecting member, a staple leg, a bone screw, a pin, a peg, or a blade, or a combination of two or more thereof. The implant according to 1 or 2.   6. Implant according to claim 5, comprising a bone plate.   Including one or more bridging members and means for fixation to the bone segment, including projecting members, staple legs, bone screws, pegs, pins, blades, or combinations of two or more thereof. The implant according to claim 1 or 2, wherein   3. Implant according to claim 1 or 2, comprising means for engaging said means for fixation to a bone segment.   9. Implant according to claim 8, wherein the means for engaging comprises a non-locking hole, a threaded locking hole, an interference hole, a tapered hole, or a combination of two or more thereof. .   An assembly for delivering an implant to a surgical site for osteosynthesis, comprising a delivery device and means for releasably attaching the implant according to claim 1 or 2 to the delivery device. An assembly characterized by that.   The delivery device comprises means for enabling preparation of the bone segment and / or means attached to the bone segment when the delivery device is releasably attached to the implant. The assembly of claim 10.   12. The means for enabling preparation of the bone segment includes means for enabling the use of a drill, screw, screwdriver, depth gauge, or a combination of two or more thereof. The assembly described.   A kit comprising the implant of claim 1 or 2 and further comprising a drill, a drill guide, a reamer, a broach, a delivery device, or a combination of two or more thereof.   14. Kit according to claim 13, comprising a sterile package.   14. The kit of claim 13, wherein the implant is releasably attached to the delivery device.   A method of implanting an implant according to claim 1 or 2, wherein the implant is placed over a surgical site comprising a bone or tissue segment, the implant being releasably engaged with a delivery device. Combining the step, adding the implant into the bone segment, and then releasing the implant from the delivery device.   17. The method of claim 16, wherein the bone segment is pre-drilled to receive the means for fixation to the bone segment or tissue segment.

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