This disclosure relates generally to bone fixation implants, and in particular relates to implants that can perform electromagnetic stimulation of a bone fracture to improve healing of the bone fracture.
When bones are damaged through trauma, disease, distraction osteogenesis, or orthognathic surgery, bone fixation implants are commonly used to provide anatomical reduction of bone fragments, to maintain their position, and to ensure union in the desired position. Thus, bone fixation implants are typically designed to achieve proper anatomic fit and function. Additionally, because bone fixation implants often support bones that withstand significant mechanical stress in their anatomic function, implants are often composed of strong and rigid materials. Intramedullary nails are example implants that are commonly used to treat fractures in long bones of the body such as fractures in femurs, tibias, and humeri. To treat such fractures, the intramedullary nail is inserted into a medullary canal of the long bone such that the nail spans across one or more fractures to fragments of the long bone that are separated by the one or more fractures. Bone anchors are then inserted through the bone and into the intramedullary, thereby fixing the intramedullary nail to the bone. The intramedullary nail can remain in the medullary canal at least until the fracture is fused.
In an example, a bone implant kit includes an implant and first and second electrical stimulation anchors. The implant define an inner surface configured to face a bone to which the bone implant kit is configured to be attached, and an outer surface opposite the inner surface. The implant further defines first and second bone fixation holes that each extend from the inner surface to the outer surface. The implant can define a first internal surface that extends from the inner surface to the outer surface so as to define the first bone fixation hole, and a second internal surface that extends from the inner surface to the outer surface so as to define the second bone fixation hole. The first and second bone fixation holes are spaced from each other along a longitudinal direction. The first electrical stimulation anchor can be sized and configured for insertion into the first bone fixation hole so as to threadedly mate with the first internal surface, and the second electrical stimulation anchor can be sized and configured for insertion into the second bone fixation hole so as to threadedly mate with the second internal surface. The first electrical stimulation anchor can include a first electrical coil wound around a first ferromagnetic core in a first direction, and the second electrical stimulation anchor can include a second electrical coil wound around a second ferromagnetic core in a second direction opposite the first direction. The first and second electrical stimulated anchors are configured to secure the implant to the bone such that the inner surface of the implant is spaced from the bone, and the first and second electrical stimulation anchors are configured to respond to a magnetic field so as to generate an electric field between the first and second electrical stimulated anchors.
In another example, an electrical stimulation anchor is configured to lock to a bone implant so as to secure the bone implant to a bone. The electrical stimulation anchor can include a head configured to lock to the bone implant, a tip opposite the head along the central anchor axis, and a shaft that connects the head to the tip. The head can define a first electrode that defines a first electrically conductive outer surface. The shaft can be elongate along the central anchor axis, and the shaft and the tip can define a second electrode that defines a second electrically conductive outer surface. Further, the electrical stimulation anchor can include an electrical insulator that defines a non-conductive outer surface disposed between the first electrically conductive outer surface and the second electrically conductive surface along the central anchor axis so as to separate the first electrode and the second electrode from each other. The non-conductive outer surface can be disposed closer to the head along the central anchor axis as compared to the tip. For example, the non-conductive outer surface can be disposed proximate to the head 112, and can extend around the central anchor axis. Further, the electrical stimulation anchor can include a ferromagnetic core disposed within the electrical insulator, and an electrical coil wound around the ferromagnetic core. The ferromagnetic core can define a core body and a core proximal end that is attached to the head so as to be configured to transfer torque applied to the head about the central anchor axis, to the shaft.
In another example, an electrical stimulation locking anchor is fabricated by winding an electric coil around a ferromagnetic core to define an electrical coil assembly. The electrical coil assembly is inserted into a cavity defined by a shaft body of the electrical stimulation anchor. A proximal end of a ferromagnetic core is attached to the head of the electrical stimulation anchor, and a distal end of the ferromagnetic core is attached to a tip of the electrical stimulation anchor that is opposite the head along a central anchor axis. The shaft body can be secured to the electrical coil, such that electrical current can be transferred between the electrical coil and the shaft body. In an example, the electrical coil assembly that is attached to the head and tip is set in a form, such that the head and the shaft body define a gap therebetween along the central anchor axis. A non-conductive polymer can be injected into a cavity defined by the by the head or the tip, such that the polymer surrounds the electrical coil assembly and fills the gap between the head and shaft body, so as to define an electrical insulator of the electrical stimulation anchor.
In yet another example, a fracture in a bone is treated by positioning a bone plate over the bone, such that the fracture is disposed between a first bone fixation hole and a second bone fixation hole along a longitudinal direction. The method of treating the fracture includes inserting a first electrical stimulation anchor into the first bone fixation hole, and inserting a second electrical stimulation anchor into the second bone fixation hole. The method of treating the fracture further includes causing an electrical field to be generated between the first and second electrical stimulation anchors. Causing the electrical field to be generated can include exposing the bone plate to a magnetic field, so as to induce an electrical current in the first electrical stimulation anchor and the second electrical stimulation anchor.
The foregoing summarizes only a few aspects of the present disclosure and is not intended to be reflective of the full scope of the present disclosure. Additional features and advantages of the disclosure are set forth in the following description, may be apparent from the description, or may be learned by practicing the invention. Moreover, both the foregoing summary and following detailed description are exemplary and explanatory and are intended to provide further explanation of the disclosure.
The foregoing summary, as well as the following detailed description of example embodiments of the present disclosure, will be better understood when read in conjunction with the appended drawings. For the purposes of illustrating the example embodiments of the present disclosure, references to the drawings are made. It should be understood, however, that the application is not limited to the precise arrangements and instrumentalities shown. In the drawings:
As an initial matter, aspects of the disclosure will now be described in detail with reference to the drawings, wherein like reference numbers refer to like elements throughout, unless specified otherwise. Certain terminology is used in the following description for convenience only, and is not limiting. The term “plurality”, as used herein, means more than one. The terms “a portion” and “at least a portion” of a structure include the entirety of the structure. Certain features of the disclosure that are described herein in the context of separate embodiments may also be provided in combination in a single embodiment. Conversely, various features of the disclosure that are described in the context of a single embodiment may also be provided separately or in any subcombination.
Referring to
The bone implant system 100 can include an implant 106, for instance a bone plate or nail, and a plurality of bone anchors 108 that are configured to secure the implant 106 to the underlying bone 104, and in particular to each of the first and second bone segments 104a and 104b. Alternatively, in accordance with another example, the bone implant system 100 includes only the plurality of bone anchors 108, such that the bone anchors 108 are configured to purchase in the bone 104 without the implant 106. The bone anchors 108 can be configured as bone pins or bone screws 110. For purposes of example, the bone anchors 108 are illustrated and often described as bone screws 110, though it will be understood that the bone anchors 108 can be alternatively configured so as to insert into the bone 104, and all such alternatives are contemplated as being within the scope of this disclosure.
Referring to
Referring in particular to
The bone implant system 100 can include one or more for instance two, bone anchors 108 that are configured as electrical stimulation anchors 111. Further, the bone screws 110 can be configured as electrical stimulation anchors 111 configured to secure the implant 106 to the bone 104. In an example configuration, the bone implant system 100 includes a first electrical stimulation locking anchor 111a adjacent to a first side 105a of the fractured portion 104c, and a second electrical stimulation locking anchor 111b adjacent to a second side 105b of the fractured portion 104c that is opposite the first side 105a of the fractured portion 104c. Thus, the first electrical stimulation locking anchor 111a can be inserted into the first bone segment 104a, and the second electrical stimulation locking anchor 111b can be inserted into the second bone segment 104b, such that the fractured portion 104c is between the first and second electrical stimulation locking anchors 111a and 111b along a longitudinal direction L. The first and second electrical stimulation locking anchors 111a and 111b can be configured to secure the implant 106 to the bone 104, and to respond to a magnetic field so as to generate an electric field between the first and second electrical stimulation locking anchors 111a and 111b. In particular, the first and second electrical stimulation locking anchors 111a and 111b can be configured to respond to a magnetic field so as to generate the electric field at the fractured portion 104c of the bone 104, so as to treat, for instance heal, the fractured portion 104c of the bone 104.
Referring now to
During a surgical procedure using the bone implant system 100, the shaft 114 of the bone anchor 108, for instance the electrical stimulation anchor 111, can be inserted through a respective one of the bone fixation holes 122 and into the underlying bone 104. The electrical stimulation anchor 111 can then be rotated, for example about the central anchor axis 125, so as to cause the threaded shaft 114 to be driven into the underlying bone 104 as the threaded shaft 114 threadedly purchases with the underlying bone 104. The threaded shaft 114 can be driven into the underlying bone 104 until the head 112 engages the implant 106. Alternatively, in an example configuration in which the bone implant system 100 does not include the implant 106, such that the electrical stimulation anchors 111 are configured as standalone screws, the threaded shaft 114 can be driven into the underlying bone 104 until the head 112 engages the underlying bone 104.
One or more up to all of the electrical stimulation anchors 111 can be configured as a compression screw whose head 112 is configured to bear against the implant 106 so as to apply a compressive force against the implant 106 toward the underlying bone 104 when the shaft 114 is driven further into the underlying bone 104 after the head 112 has contacted the outer plate surface 120. The shaft 114 can be driven into the underlying bone a sufficient distance until the desired compressive force has been imparted onto the implant 106. The head 112 of the compression screw can be unthreaded. Similarly, at least a portion up to an entirety of the internal surface 124 can be unthreaded.
In another example, one or more up to all of the electrical stimulation anchors 111 can be configured as locking screws that are configured to lock to the implant 106. Therefore, unless otherwise specified, the electrical stimulation anchors 111 can also be referred to as electrical stimulation locking anchors 111. In particular, the head 112 can be externally threaded. The internal surface 124 can be similarly threaded so as to be configured to threadedly mate with the threaded head 112. Accordingly, during operation, the shaft 114 can be inserted through the fixation hole 122 and driven into the underlying bone 104 as described above. In particular, when the electrical stimulation anchor 111 is a locking screw, rotation of the anchor 111 causes the threaded head 112 to threadedly mate with the internal surface 124. As a result, the screw head 112 fastens the implant 106 to the underlying bone 104 without applying a compressive force onto the implant 106 against the underlying bone 104. The implant 106 can be spaced from the underlying bone 104 when locked to the head 112. Alternatively, the implant 106 can abut the underlying bone 104 when locked to the head 112. At least a portion of the internal surface 124 can be tapered so as to extend in an axially inward direction, for example toward the central hole axis 115, as the internal surface 124 extends from the outer plate surface 120 toward the inner plate surface 118. Thus, the internal surface 124 can be configured to prevent the head 112 from passing completely through the fixation hole 122. The head 112 can define at least one external thread that is circumferentially continuous about the central anchor axis 125. It should be appreciated, however, that the head 112 can be alternatively constructed in any manner desired so as to threadedly mate with the internal surface 124 as described herein.
According to one embodiment, one or more of the fixation holes 122 of the bone implant 106 can be configured as a variable angle locking hole that is configured to threadedly mate with the bone screw 110 at different orientations of the bone screw 110 with respect to the central hole axis 115. That is, when the fixation hole 122 is configured as a variable angle locking hole, the plate 116, and thus the implant 106, includes at least one thread that projects out from the internal surface 124 into the fixation hole 122.
The bone screw 110 can be configured to be inserted into the fixation hole 122 such that the central anchor axis 125 is at one of a plurality of orientations with respect to the central hole axis 115 within a range of orientations at which the threaded head 112 is configured to threadedly mate with the at least one thread in the fixation hole 122. For instance, the bone screw 110 can be configured to be inserted into the fixation hole 122 such that the central anchor axis 125 is at one of a plurality of angles within a range of angles defined by the central anchor axis 125 and the central hole axis 115 at which the threaded head 112 is configured to threadedly mate with the at least one thread in the fixation hole 122. The range of angles can be from approximately zero degrees to approximately thirty degrees. Thus, the range of angles can define a cone of up to approximately sixty degrees. The central anchor axis 125 can be coincident with the central hole axis 115 in one of the orientations in the range of orientations. The at least one thread in the fixation hole 122 and the threads of the head 112 can be defined prior to insertion of the bone screw 110 into the variable angle locking hole. That is, the internal surface 124 can be designed or configured such that threads are not cut into the bone screw head 112. Similarly, the bone screw head 112 can be designed or configured so as to cut no threads into the internal surface 124.
Referring generally to
In an example configuration, the first and second electrical stimulation anchors 111a and 111b are substantially the same size as each other, and thus the first and second bone fixation holes 122a and 122b can be substantially the same size as each other. The first and second bone fixation holes 122a and 122b can each extend from the inner plate surface 118 to the outer plate surface 120. The first and second bone fixation holes 122a and 122b can configured to be spaced from each other along the longitudinal direction L such that the fractured portion 104c of the bone 104 to which the bone implant system (kit) 100 is configured to be attached is disposed between the first and second bone fixation holes along the longitudinal direction L when the implant 106 is positioned over the bone. The first and second bone fixation holes 122a and 122b can be adjacent to each other such that no bone fixation holes 122 are between the first and second bone fixation holes along the longitudinal direction L. It will be understood that the bone fixation holes, and thus the electrical stimulation anchors, can be alternatively located, and the location of bone fixation holes and the electrical stimulation anchors may depend on the size and shape of the fracture being treated.
Referring again to
Referring in particular to
Referring again to
Referring also
The electrical stimulation anchor 111 can be elongate from the proximal end 130 to the distal end 128. For instance, the screw can be substantially elongate along the central anchor axis 125 that extends from the proximal end 130 to the distal end 128. It will be appreciated that the central anchor axis 125 of the electrical stimulation anchor 111 can be straight or curved. Thus, the shaft 114 can be straight or curved as it extends along the central anchor axis 125 from the head 112 to the tip 136.
Referring in particular to
Referring also to
Referring in particular to
Referring now to the example illustrated in
The core 148 can further define a core distal end 156b disposed at a second end of the core body 154 that is opposite the first end of the core body 154 along the central anchor axis 125. The core 148, for instance the core distal end 156b, can be attached to the tip 136 so as to be configured to transfer torque applied to the shaft 114 about the central anchor axis 125, to the tip 136. Thus, torque applied to the head 112 can be transferred to the core 148, which in turn can transfer the torque to the tip 136. The core 148, for instance the core distal end 156b, can be attached to the tip 136 of the electrical stimulation anchor 111, for instance by press-fit, so as to mechanically connect the electrical coil assembly 142 with the tip 136. The core distal end 156b can extend outward from the central anchor axis 125 with respect to the core body 154.
Still referring to
The electrical insulator 152 can include an insulator proximal end 160 that can support the shaft body 140. The insulator proximal end 160 can define the insulator outer surface 152a. The electrical insulator 152 can include an insulator body 161 that can be disposed within the cavity 144 of the shaft body 140. The insulator proximal end 160 can extend outward from the central anchor axis 125 with respect to the insulator body 161, such that the insulator outer surface 152a defines a portion of the outer surface of the electrical stimulation anchor 111. The shaft body 140 can be electrically conductive so as to define at least a portion of the second electrode 134. The insulator proximal end 160 can extend outward from the central anchor axis 125 a distance that is greater than the insulator body extends outward from the central anchor axis 125. Thus, the insulator proximal end 160 can separate the shaft body 140 from the head 112, such that the shaft body 140 and the head 112 do not contact each other. Thus, the insulator proximal end 160, in particular the insulator outer surface 152a of the insulator proximal end 160, can be disposed between head 112 and the shaft 114 so as to electrically separate the first electrode 132 and the second electrode 134 from each other. Further, the outer surface 140a of the shaft body 140 can define the unthreaded portion 119. Thus, the shaft body 140 can be disposed between the first threaded portion 117a and the second threaded portion 117b along the central anchor axis 125. The shaft body 140 can be attached or can be monolithic with the tip 136. The shaft body 140 can also define a proximal shaft body end 140c and a distal shaft body end 140d opposite the proximal shaft body end 140c along the central anchor axis 125. The proximal shaft body end 140c can abut the insulator proximal end 160, and the distal shaft body end 140d can be attached to the tip 136, so as to electrically couple the shaft body and the tip 136.
With continuing reference to
In an example manufacturing process, the electrical coil 146 can be wound around the ferromagnetic core 148 to define the electrical coil assembly 142. The electrical coil assembly 142 can be inserted into the cavity 144 defined by the shaft body 140 of the electrical stimulation locking anchor 111. The core proximal end 156a can be attached to the head 112, and the core distal end 156b can be attached to the tip 136 that is opposite the head 112 along the central anchor axis 125. The shaft body 140 can be secured to the electrical coil 146, such that electrical current can be transferred between the electrical coil 146 and the shaft body 140. The electrical coil assembly 142 that is attached to the head 112 and the tip 136 can be set in a form, such that the head 112 and the shaft body 140 define a gap therebetween along the central anchor axis 125. A non-conductive polymer can be injected into the cavity 170 defined by the head 112 or the cavity 172 defined by the tip 136, such that the polymer surrounds the electrical coil assembly 142, for example, so as to define the electrical insulator 152. The non-conductive polymer can be injected such that the polymer fills the gap between the head 112 and shaft body 140, so as to define the insulator proximal end 160, and in particular the insulator outer surface 152a, of the electrical insulator 152.
In an example, epoxy is injected at the head 112 to mold the electrical insulator 152 around the coil assembly 142. Before injection molding the electrical insulator 152 in a form, in an example, the electrically conductive portions of the electrical stimulation anchor 111 are positioned in a form or mold. The clip 162 and the placeholder 164 can hold the coil 146 in place relative to the core 148 in the form, so that the electrical coil assembly is centered within the electrical insulator 152 after injection molding insulator material to form the electrical insulator 152 around the electrical coil assembly 142.
Referring now to the example illustrated in
The core distal end 202b can be attached to the tip 136 of the electrical stimulation anchor 111, for instance by press-fit, so as to mechanically connect the electrical coil assembly 142 with the tip 136. For example, the core distal end 202b can define a hexagonal shape, so as to be received in a press-fit with the head 112. It will be understood that the core distal end 202b can be alternatively shaped as desired. For example, the core distal end 202b can extend outward from the central anchor axis 125 with respect to the core body 200. The coil 146 can be wound from the core proximal end 202a, to the core distal end 202b, on the external surface 150 and about the central anchor axis 125. The coil 146 can be wound in a clockwise or counterclockwise direction. The external surface 150 of the core body 200 can extend from the core proximal end 202a to the core distal end 202b. The core body 200 can define a cylinder, though it will be understood that the core body 200 can be alternatively shaped as desired.
Referring in particular to
In operation, referring also to
As described above, the plate 116 can electrically connect the first electrode 132 of the first electrical stimulation locking anchor 111a with the first electrode 132 of the second electrical stimulation locking anchor 111b. It is recognized herein that this configuration can increase the predictability and reliability of the electric field that is generated by the first and second electrical stimulation anchors 111a and 111b. Without being bound by theory, it is further recognized herein that this arrangement that includes the electrical stimulation locking anchors 111 having the insulative outer surface 152a disposed proximate to the head 112 can strengthen the electric field as compared to an electric field that is generated between anchors having the same polarity as each other. It is further recognized herein that this arraignment that includes the electrical stimulation locking anchors 111 having the insulator outer surface 152a disposed proximate to the head 112 can strengthen the electric field as compared to the same arrangement with different locking anchors that have an outer insulative portion disposed closer to the tip 136 as compared to the insulative outer surface 152a of the electrical stimulation locking anchors 111. Thus, it is recognized herein that adjacent electrical stimulation locking anchors that are secured to an implant and that have first and second electrodes separated at a location proximate to the head 112 can strengthen the electric field as compared to adjacent electrical stimulation anchors that are secured to an implant and that have first and second electrodes disposed proximate to the tip. Having the first and second electrodes disposed proximate to the head 112 can, in some cases, reduce the mechanical strength of the anchor, such that the anchor cannot be configured to function as a locking anchor. Without being bound by theory, it is also recognized herein that the above-described electrical stimulation locking anchors 111 are configured for electrical stimulation while maintaining the mechanical strength required to function as a locking screw, so as to transfer torque about the central anchor axis 125 from the head 112 to the tip 136. Further still, it is recognized herein that the ferromagnetic core 148 can strengthen the electric field that is generated as compared to an electrical coil assembly without the ferromagnetic core 148.
In response to the magnetic field generated by the PEMF device 102, by way of example, a current can be induced in the coil 146 of the first electrical stimulation anchor 111a from the proximal end 130 to the distal end 128 of the first electrical stimulation anchor 111a, and the current can be induced in the coil 146 of the second electrical stimulation anchor 111b from the distal end 128 to the proximal end 130. Thus, the electrical field generated by the induced currents can be strengthened, so as to better treat a fracture.
Referring to
Thus, as described above, a method for treating a fracture in a bone can include positioning a bone plate over the bone, such that the fracture is disposed between a first bone fixation hole and a second bone fixation hole along a longitudinal direction. The method can further include inserting a first electrical stimulation anchor into the first bone fixation hole, and inserting a second electrical stimulation anchor into the second bone fixation hole. Further still, the method can include causing an electrical field to be generated between the first and second electrical stimulation anchors. In some cases, causing the electrical field to be generated includes exposing the bone plate to a magnetic field, so as to induce an electrical current in the first electrical stimulation anchor and the second electrical stimulation anchor. The first electrical stimulation anchor can include a first coil wrapped in a first direction, and the second electrical stimulation anchor includes a second coil wound in a second direction opposite the first direction. In some examples, the method for treating the fracture includes connecting a proximal end of the first electrical stimulation anchor to an electrical conductor of the bone plate, and connecting a proximal end of the second electrical stimulation anchor to the electrical conductor of the bone plate, so as to electrically couple the proximal end of the first electrical stimulation anchor with the proximal end of the second electrical stimulation anchor. Causing the electrical field to be generated can also include exposing the first electrical stimulation anchors to a magnetic field so as to induce a first electrical current from the proximal end of the first electrical stimulation anchor to a distal end of the first electrical stimulation anchor that is opposite the proximal end, and exposing the second electrical stimulation anchor to the magnetic field so as to induce a second electrical current from a distal end of the second electrical stimulation anchor to the proximal end of the second electrical stimulation anchor, wherein the distal end of the second electrical stimulation anchor is opposite the proximal end of the second electrical stimulation anchor.
While the techniques described herein can be implemented and have been described in connection with the various embodiments of the various figures, it is to be understood that other similar embodiments can be used or modifications and additions can be made to the described embodiments without deviating therefrom. For example, it should be appreciated that the steps disclosed above can be performed in the order set forth above, or in any other order as desired. Further, one skilled in the art will recognize that the techniques described in the present application may apply to any environment, whether wired or wireless, and may be applied to any number of such devices connected via a communications network and interacting across the network. Therefore, the techniques described herein should not be limited to any single embodiment, but rather should be construed in breadth and scope in accordance with the appended claims.
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