Piezoelectric orthopedic implants and methods

Abstract

An orthopedic implant assembly includes a bone plate configured to couple the implant assembly to a fractured bone. The piezoelectric element is disposed on the bone plate and is configured to generate an electrical output corresponding to a load on which the piezoelectric element is subjected. The electrical output is transmitted to the fractured bone when the implant is in contact with the fractured bone.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 63 / 335,343 filed on April 27, 2022 and U.S. Provisional Patent Application No. 63 / 396,019 filed on August 8, 2022, each of which is hereby incorporated by reference in its entirety. Technical Field

[0003] The present invention relates to bone implants and, more particularly, to bone implant assemblies and methods including piezoelectric materials capable of generating an electrical output that can stimulate bone and tissue growth surrounding the implant. Background Art

[0004] A key factor in the successful repair of a fractured bone or spinal fusion in orthopedic surgery is the patient's body's ability to successfully repair and regenerate bone structure in the area of ​​the fracture, spinal fusion or bone defect treatment. It is well known that electrical stimulation promotes and stimulates bone growth and bone healing. However, prior art electrical stimulation devices used after orthopedic surgery often require multiple surgeries for implantation and removal because they require batteries that require recharging or replacement. Alternatively, in the case of external stimulation, the patient may need to wear the stimulation device for most of the day. Summary of the invention

[0005] According to one embodiment of the present invention, orthopedic implant assembly comprises bone plate, and this bone plate is configured to couple implant assembly to the bone of fracture.Piezoelectric layer is combined with bone plate, and is configured to produce the electric output corresponding to the load borne by piezoelectric layer.When piezoelectric layer contacts with the bone of fracture, the electric output is transmitted to the bone of fracture.

[0006] According to a related embodiment of the present invention, the bone of the fracture can be a femur, a tibia, a fibula, a humerus, an ulna, a radius, a vertebra, a bone of a shoulder joint, a bone of a hip joint and / or a bone of an ankle joint. The load can be an anatomical load. The piezoelectric layer can include polyvinylidene fluoride and / or polyvinylidene fluoride (PVDF). The bone plate can have a bottom surface with undulations, and the piezoelectric layer can be arranged on the bottom surface, and the bottom surface is configured to compress the piezoelectric layer so as to drive the electrical output of the piezoelectric layer.

[0007] According to further embodiments of the present invention, the piezoelectric layer may include a lip configured to wrap around the underside of the bone plate. The bone plate may include a groove configured to receive the piezoelectric layer. The bone plate may also include a set of fasteners configured to fix the piezoelectric layer in the groove. According to embodiments of the present invention, the piezoelectric layer may have a ribbon shape and may be configured to wrap around the bone plate at the fracture site.

[0008] According to another embodiment of the present invention, orthopedic implant assembly comprises the first bone plate, and this first bone plate has the shape that is suitable for the first side of implant assembly is coupled to the bone of fracture, and has the second side of ups and downs.Piezoelectric layer is arranged between the first bone plate and the second bone plate, and is configured to produce the electric output corresponding to the load borne by piezoelectric layer.The second bone plate has the downside of ups and downs, and is arranged on the piezoelectric layer.The piezoelectric layer is compressed between the downside of the second side of the ups and downs of the first bone plate and the downside of the ups and downs of the second bone plate.When at least one of the first bone plate and the second bone plate contacts with the bone of fracture, the electric output is transmitted to the bone of fracture.

[0009] According to a related embodiment of the present invention, the bone of fracture can be the bone of femur, tibia, fibula, humerus, ulna, radius, vertebra, shoulder joint, the bone of hip joint and / or the bone of ankle joint.Orthopedic implant assembly comprises a group of fasteners, wherein the first bone plate, piezoelectric layer and the second bone plate each have a group of opening, these groups of openings are aligned with each other, so that each in this group of fasteners protrudes into the bone of fracture by the opening aligned.This group of fasteners can be configured to transmit electrical output to the bone of fracture.The material of each in the first and second bone plates can be conductive material and / or non-conductive material.Load can be anatomical load.Piezoelectric layer can include polyvinylidene fluoride and / or polyvinylidene fluoride (PVDF).

[0010] According to another embodiment of the present invention, the orthopedic implant assembly comprises: a bone plate, which has a shape suitable for coupling the implant assembly to the bone of a fracture, and has a group of openings; and a group of piezoelectric rings, each ring in the group of piezoelectric rings is arranged in an opening in the group of openings, and is configured to produce an electrical output corresponding to the load borne by the ring. The assembly also comprises a group of fasteners, each fastener is arranged in an opening in the group of openings, so as to protrude into the bone of a fracture. The group of fasteners is configured to transmit electrical output to the bone of a fracture.

[0011] According to a related embodiment of the present invention, the fractured bone can be a femur, a tibia, a fibula, a humerus, an ulna, a radius, a vertebra, a bone of a shoulder joint, a bone of a hip joint, and / or a bone of an ankle joint. The material of the bone plate can be a conductive material, wherein the bone plate is configured to transmit an electrical output to the fractured bone.

[0012] According to further related embodiment, orthopedic implant assembly can include one group of insulating rings, each insulating ring is arranged between corresponding piezoelectric ring and corresponding opening, wherein the material of each fastener in the group of fasteners is conductive material, so that electrical output is only transmitted to the bone of fracture by fasteners.Load can be anatomical load.Piezoelectric layer can include polyvinylidene fluoride and / or polyvinylidene fluoride (PVDF).

[0013] According to another embodiment of the present invention, an interspinous plate for vertebrae is provided. The interspinous plate includes a first end plate and a second end plate. A central tube is disposed between the first end plate and the second end plate and coupled to the first end plate and the second end plate. At least one of the first end plate and the second end plate includes a piezoelectric layer disposed on the end plate, the piezoelectric layer being configured to generate an electrical output corresponding to a load borne by the piezoelectric layer. The central tube is made of an insulating material. The interspinous plate is configured to couple to the spinous process of the vertebra and is also configured to transmit the electrical output into the spinous process.

[0014] According to a related embodiment of the present invention, at least one of the first end plate and the second end plate may include a plurality of teeth configured to engage with the spinous process. The piezoelectric layer may include polyvinylidene fluoride and / or polyvinylidene fluoride (PVDF). The surface of the central tube facing the piezoelectric layer may have undulations, and the undulating surface of the central tube is configured to compress the piezoelectric layer so as to drive the electrical output of the piezoelectric layer.

[0015] According to another embodiment of the present invention, an interspinous plate for a vertebra includes a first end plate and a second end plate. A central tube is disposed between the first end plate and the second end plate and is coupled to the first end plate and the second end plate. The central tube is made of a piezoelectric material and is configured to generate an electrical output corresponding to the load borne by the implant. The interspinous plate is configured to couple to the spinous process of the vertebra and is also configured to transmit the electrical output into the spinous process.

[0016] According to a related embodiment of the invention, at least one of the first endplate and the second endplate comprises a plurality of teeth configured to engage with the spinous processes.The piezoelectric layer may comprise polyvinylidene fluoride and / or polyvinylidene difluoride (PVDF).

[0017] According to another embodiment of the present invention, a pedicle screw assembly includes: a body configured to be screwed into a vertebra, a screw head saddle disposed on the body, a piezoelectric layer disposed on the screw head saddle and configured to generate an electrical output corresponding to a load borne by the pedicle screw assembly, a rod saddle disposed on the piezoelectric layer, and a head disposed to the rod saddle. The rod saddle has a contoured underside, and the screw head saddle has a contoured top surface, the contoured underside and the contoured top surface are configured to compress the piezoelectric layer so as to drive the electrical output of the piezoelectric layer.

[0018] According to a related embodiment of the present invention, the rod saddle may be an insulator.The screw head saddle may be an insulator.

[0019] According to another embodiment of the present invention, a pedicle screw assembly includes a plurality of pedicle screws, each pedicle screw having a head, a neck and a body. A rod is coupled to the head of each of the plurality of pedicle screws. A plurality of piezoelectric layers are each disposed on the neck of a corresponding one of the plurality of pedicle screws and are configured to generate an electrical output corresponding to the load borne by the screw and / or the rod. The body of each pedicle screw is configured to be screwed into a vertebra and is further configured to transmit the electrical output to the vertebra.

[0020] According to a related embodiment of the present invention, the pedicle screw assembly also includes a piezoelectric rod layer disposed on the rod and configured to generate an additional electrical output corresponding to the load borne by the screw and / or the rod. The load may be an anatomical load. The piezoelectric layer may include polyvinylidene fluoride and / or polyvinylidene difluoride (PVDF).

[0021] According to another embodiment of the present invention, the knee joint implant assembly comprises a tibia implant configured to be coupled to tibia and a femur implant configured to be coupled to femur.The tibia implant comprises a piezoelectric layer arranged on the implant, and this piezoelectric layer is configured to produce the electrical output corresponding to the load borne by the implant.The knee joint implant assembly is configured to transmit the electrical output to at least one of tibia and the femur.

[0022] According to a related embodiment of the present invention, the tibial implant may have an undulating upper surface, the piezoelectric layer is disposed on the undulating upper surface, and the undulating upper surface is configured to compress the piezoelectric layer so as to drive the electrical output of the piezoelectric layer. The piezoelectric layer may include polyvinylidene fluoride and / or polyvinylidene fluoride (PVDF).

[0023] According to another embodiment of the present invention, an intramedullary nail assembly includes: a lower shaft having a lower insulating cap; a first piezoelectric ring disposed on the lower insulating cap and configured to generate an electrical output corresponding to a load borne by the intramedullary nail assembly; an electrical conductor disposed on the first piezoelectric ring; a second piezoelectric ring disposed on the electrical conductor and configured to generate an electrical output corresponding to a load borne by the intramedullary nail assembly; and an upper shaft disposed on the second piezoelectric ring and having an upper insulating cap. The lower insulating cap has a contoured top surface, and the upper insulating cap has a contoured lower side, and the contoured lower side and the contoured top surface are configured to compress the first piezoelectric ring and the second piezoelectric ring so as to drive the electrical output of the piezoelectric rings.

[0024] According to a related embodiment of the present invention, the piezoelectric layer includes polyvinylidene fluoride and / or polyvinylidene fluoride (PVDF).

[0025] According to another embodiment of the present invention, a bone screw assembly includes a body configured to couple to a bone, a head, and a washer having a piezoelectric layer disposed therein. The piezoelectric layer is configured to generate an electrical output corresponding to a load experienced by the bone screw assembly.

[0026] According to a related embodiment of the present invention, the screw head may have a relief configured to drive an electrical output of the piezoelectric layer. The piezoelectric layer may include polyvinylidene fluoride and / or polyvinylidene difluoride (PVDF).

[0027] According to another embodiment of the present invention, a hip replacement assembly includes an acetabular component configured to be coupled to the acetabulum. An acetabular piezoelectric layer is provided on the joint surface of the acetabular component, and the acetabular piezoelectric layer is configured to generate a first electrical output corresponding to the load borne by the acetabular piezoelectric layer. An insulating liner is provided on the acetabular piezoelectric layer. A femoral component is configured to be coupled to the femur and includes a femoral head and a femoral stem. The femoral piezoelectric layer is provided on the femoral stem and is configured to generate a second electrical output corresponding to the load borne by the femoral piezoelectric layer. The acetabular component is configured to transmit the first electrical output to the acetabulum, and the femoral component is configured to transmit the second electrical output to the femur.

[0028] According to a related embodiment of the present invention, the acetabular piezoelectric layer and the femoral piezoelectric layer include polyvinylidene fluoride and / or polyvinylidene fluoride (PVDF).

[0029] According to another embodiment of the present invention, a bone spacer assembly includes: a bottom end plate having a contoured top surface; a first piezoelectric layer disposed on the bottom end plate and configured to generate a first electrical output corresponding to a load borne by the first piezoelectric layer; an insulator disposed on the first piezoelectric layer and having a contoured top surface and a contoured bottom surface; a second piezoelectric layer disposed on the insulator and configured to generate a second electrical output corresponding to a load borne by the second piezoelectric layer; and a top end plate having a contoured bottom surface. The contoured top surface of the bottom end plate and the contoured bottom surface of the insulator are configured to compress the first piezoelectric layer so as to drive the electrical output of the first piezoelectric layer. The contoured top surface of the insulator and the contoured bottom surface of the top end plate are configured to compress the second piezoelectric layer so as to drive the electrical output of the second piezoelectric layer.

[0030] According to a related embodiment of the present invention, each of the top end plate, the second piezoelectric layer, the insulator, and the first piezoelectric layer may have a central groove, wherein the bottom end plate may have a raised central portion, the raised central portion of which is configured to protrude through the first piezoelectric layer, the insulator, the second piezoelectric layer, and the central groove of the top end plate. The bone spacer assembly may include a set of assembly pins. The top end plate may have a set of pin holes, and the raised central portion of the bottom end plate may have a set of expansion holes corresponding to the set of pin holes, so that each of the assembly pins in the set protrudes through one of the pin holes in the set and a corresponding one of the expansion holes in the set.

[0031] According to another embodiment of the present invention, a bone spacer assembly includes: a bottom end plate having a contoured top surface; a first piezoelectric layer disposed on the bottom end plate and configured to generate a first electrical output corresponding to a load borne by the first piezoelectric layer; and a top end plate having a contoured bottom surface.

[0032] According to a related embodiment, a bone spacer assembly may include: an insulator disposed on a first piezoelectric layer and having a contoured top surface and a contoured bottom surface; a second piezoelectric layer disposed on the insulator and configured to generate a second electrical output corresponding to a load borne by the second piezoelectric layer; the contoured top surface of the bottom end plate and the contoured bottom surface of the insulator are configured to compress the first piezoelectric layer so as to drive the electrical output of the first piezoelectric layer. The contoured top surface of the insulator and the contoured bottom surface of the top end plate are configured to compress the second piezoelectric layer so as to drive the electrical output of the second piezoelectric layer.

[0033] According to another embodiment of the present invention, a method for manufacturing an implant includes the following steps: compressing a piezoelectric film between a bottom surface of a top end plate and a top surface of a bottom end plate, wherein the bottom surface of the top end plate and the top surface of the bottom end plate have undulations, and wherein, by applying pressure, the piezoelectric film conforms to the undulations; drilling a set of pin holes through the top end plate and the bottom end plate; expanding the set of pin holes of the bottom end plate to produce extended holes so that the top boundaries of the extended holes are aligned with the top boundaries of the pin holes of the top end plate; and inserting a set of assembly pins through the pin holes of the top end plate and the extended holes of the bottom end plate so that the piezoelectric film remains compressed. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] The foregoing features of the embodiments will be more readily understood by reference to the following detailed description taken in conjunction with the accompanying drawings, in which:

[0035] Figure 1 An implant assembly according to an embodiment of the present invention is shown;

[0036] Figure 2 An implant assembly according to an embodiment of the present invention is shown;

[0037] Figure 3 An implant assembly according to an embodiment of the present invention is shown;

[0038] Figure 4 An implant assembly according to an embodiment of the present invention is shown;

[0039] Figure 5 An implant assembly according to an embodiment of the present invention is shown;

[0040] Figure 6 An implant assembly according to an embodiment of the present invention is shown;

[0041] Figure 7 An implant assembly according to an embodiment of the present invention is shown;

[0042] Figure 8 An implant assembly according to an embodiment of the present invention is shown;

[0043] Fig. 9 An implant assembly according to an embodiment of the present invention is shown;

[0044] Fig.10 An implant assembly according to an embodiment of the present invention is shown;

[0045] Fig.11 An interspinous fixation plate according to an embodiment of the present invention is shown;

[0046] Fig.12 A dynamic interspinous fixation plate according to an embodiment of the present invention is shown;

[0047] Fig.13A A pedicle screw assembly according to an embodiment of the present invention is shown;

[0048] Fig. 13B A pedicle screw assembly according to an embodiment of the present invention is shown;

[0049] Fig.14 A pedicle screw assembly according to an embodiment of the present invention is shown;

[0050] Fig.15 A pedicle screw assembly according to an embodiment of the present invention is shown;

[0051] Fig.16 A pedicle screw assembly according to an embodiment of the present invention is shown;

[0052] Fig.17 A joint implant assembly according to an embodiment of the present invention is shown;

[0053] Fig.18 An intramedullary nail assembly according to an embodiment of the present invention is shown;

[0054] Fig.19 An intramedullary nail assembly according to an embodiment of the present invention is shown;

[0055] Fig. 20 An intramedullary nail assembly according to an embodiment of the present invention is shown;

[0056] Fig.21 An intramedullary screw assembly according to an embodiment of the present invention is shown;

[0057] Fig. 22 A hip replacement assembly according to an embodiment of the present invention is shown;

[0058] Fig.23 A bone spacer assembly according to an embodiment of the present invention is shown;

[0059] Fig.24 A method of assembling a bone spacer assembly according to an embodiment of the present invention is shown;

[0060] Fig.25 A method of assembling a bone spacer assembly according to an embodiment of the present invention is shown; and

[0061] Fig.26 The mechanism of activating PVDF according to an embodiment of the present invention is shown;

[0062] Fig. 27 A knee joint implant assembly according to an embodiment of the present invention is shown;

[0063] Fig.28 An implant assembly according to an embodiment of the present invention is shown. DETAILED DESCRIPTION

[0064] Definitions. As used in this specification and the appended claims, the following terms shall have the indicated meanings unless the context requires otherwise:

[0065] A "group" consists of at least one member.

[0066] In an illustrative embodiment of the present invention, a kind of implant assembly is provided, and it comprises the piezoelectric material arranged on bone plate or other suitable framework.The implant assembly can be directly installed on or near the bone of fracture.The stress applied on the implant assembly (particularly piezoelectric material) produces electrical output, and this electrical output is transmitted near fracture, thereby promotes and stimulates bone growth and bone healing.The piezoelectric material can advantageously be polyvinylidene fluoride or polyvinylidene fluoride (hereinafter referred to as PVDF), which is biocompatible and can be used for long-term direct contact with body tissue.Other piezoelectric materials known in the art can also be used.Details are provided below.

[0067] Piezoelectric materials are known to have different response levels depending on the direction and magnitude of the applied force. The force can be about 10N, 25N, 50N, 100N, 200N, 500N, 700N, 1000N, 1500N, 3000N, 5000N or 10000N. The force can be variable, and the range is between an upper limit and a lower limit. The electrical output can include a voltage of about 0.1mV, 0.3mV, 0.5mV, 1mV, 10mV, 25mV, 100mV, 200mV, 500mV, 700mV, 1V, 2V, 3V, 4V, 5V, 6V, 7V, 10V, 15V or 20V. The voltage output can be variable, and the range is between an upper limit and a lower limit. The electrical output can include an electric current of about 50nA, 100nA, 500nA, 1000nA, 3000nA, 5000nA, 7000nA, 10000nA, 50000nA, 100000nA, 250000nA, 500000nA, 750000nA, 1mA, 5mA, 10mA, 15mA, 25mA, 35mA or 50mA. The current output can be variable, and the range is between the upper and lower limits. All ranges between the above any values ​​are disclosed herein. Stress is usually decomposed into directional components and described by a 3x 3 "Cauchy stress tensor" matrix, where d11, d22 and d33 are axial compressions along the x-axis, y-axis and z-axis, respectively.

[0068] The embodiments described in this application are directed to several novel designs of implants that decompose common biomechanical load conditions into planar shear stresses on piezoelectric materials to drive the electrical signals generated. For example, by conforming the piezoelectric material to a novel waveform or other non-planar shape, this waveform not only increases the total area of ​​the piezoelectric material that can be loaded, but also makes most of the material at an angle of 30 to 60 degrees relative to the vertical axis. This means that when the patient walks forward or bends and subjects the implant to a simple compression or shear load, most piezoelectric materials will actually experience planar shear stresses. This design creates significant advantages in the performance of the final product. The present application may describe components with contoured surfaces. Unless otherwise specified, contoured surfaces may include non-planar surfaces, such as undulations, waveforms, jagged, curves, creases, bends, any combination of these, or any structural geometry that results in the application of uneven forces.

[0069] Figure 1An implant assembly according to an embodiment of the present invention is shown. Implant assembly 100 includes a bone plate or trauma plate 102. Bone plate 102 can be made of titanium or any other material suitable for orthopedic implants. Bone plate 102 is configured to be coupled to a bone (not shown) of a fracture and has a shape suitable for being coupled to a bone of a fracture. Piezoelectric cover layer 104 is configured to be arranged on bone plate 102. Piezoelectric layer 104 produces an electrical output corresponding to the load (e.g., anatomical load) borne by the piezoelectric layer. As described above, piezoelectric layer 104 can be made of polyvinylidene fluoride or polyvinylidene fluoride (hereinafter referred to as PVDF) illustratively, or made of any other piezoelectric material suitable for orthopedic implants. For example, the shape of piezoelectric layer 104 corresponds to the shape of bone plate 102, so that piezoelectric layer 104 wraps the lower side of bone plate 102. For example, piezoelectric layer 104 can have a lip along its edge, so that piezoelectric layer 104 encapsulates the bottom and side of bone plate 102. Implant assembly 100 also can comprise one group of opening 108 and 118, is used for implant assembly is coupled to the bone of fracture.Opening 108 can be positioned in bone plate 102 and / or opening 118 can be positioned in piezoelectric layer 104.When implant assembly is coupled to the bone of fracture, opening 108 and 118 can align, and each member in this group of opening 108 corresponds to a member in this group of opening 118.

[0070] Implant assembly 100 is configured to use a set of fasteners to be coupled to the bone of fracture, as shown below with reference to Figure 6 As shown. Each fastener in the set of fasteners corresponds to one of the aligned openings 108 and 118. For example, the fasteners may be lag screws, and the openings 108 and 118 may be threaded. However, it is expressly contemplated that any other fastener suitable for orthopedic implants may be used.

[0071] Figure 2An implant assembly according to an embodiment of the present invention is shown. Implant assembly 200 comprises bone plate 202 and piezoelectric layer 204. Bone plate 202 comprises groove 210, and piezoelectric layer 204 is inserted in groove 210. Bone plate 202 can also comprise fastener 212, and fastener 212 is configured to fix piezoelectric layer 204 in groove 210. These fasteners 212 can be, for example, pins or screws. Piezoelectric layer 204 is configured to produce an electrical output corresponding to the load (for example, anatomical load) borne by piezoelectric layer. The shape of piezoelectric layer 204 corresponds to the shape of bone plate 202, so that piezoelectric layer 204 can be inserted in groove 210. Implant assembly 200 also comprises a group of openings 208 and / or 218, for coupling implant assembly to bone of fracture. Opening 208 can be located in bone plate 202, and / or opening 218 can be located in piezoelectric layer 204. When the implant assembly is coupled to a fractured bone, openings 208 and 218 can be aligned such that each member of the set of openings 208 corresponds to a member of the set of openings 218 .

[0072] Figure 3 Implant assembly according to an embodiment of the present invention is shown.Implant assembly 300 comprises bone plate 302 and piezoelectric band 304.Piezoelectric band 304 is preassembled on bone plate 302, and is positioned at common fracture site.Piezoelectric band 304 is configured to produce the corresponding electrical output of the load (such as anatomical load) borne with piezoelectric layer.Implant assembly 300 also comprises a group of opening 308, is used for using a group of fastener 306 that implant assembly is coupled to the bone 312 of fracture.When implant assembly 300 is coupled to the bone 312 of fracture, piezoelectric band 304 can be positioned to make it cross fracture site 310.

[0073] Figure 4 Implant assembly according to an embodiment of the present invention is shown.Implant assembly 400 comprises bone plate 402 and piezoelectric band 404.Bone plate 402 comprises one group of openings 408, for the implant assembly being coupled to the bone of fracture.Piezoelectric band 404 is configured to slide over or be fastened to bone plate 402, so that it can be positioned between two openings 408 of fracture zone.Piezoelectric band 404 is configured to produce the corresponding electrical output of the load (such as anatomical load) borne with piezoelectric layer.When implant assembly 400 is coupled to the bone (not shown) of fracture, piezoelectric band 404 can be positioned to be positioned on fracture site or cross fracture site.

[0074] Figure 5Describe the implant assembly according to an embodiment of the present invention.Implant assembly 500 comprises a first bone plate 502, an optional second bone plate 506, and a piezoelectric layer 504, which is coupled to the first bone plate 502 or is sandwiched between the first bone plate 502 and the second bone plate 506.At least one of the first and second bone plates is configured to couple implant assembly 500 to a bone (not shown) of a fracture.The first bone plate 502 is arranged on the piezoelectric layer 504, and the piezoelectric layer 504 is arranged on the second bone plate 506.For example, bone plates 502 and 506 and piezoelectric layer 504 have the same shape, which is suitable for being coupled to a bone of a fracture.The first bone plate 502 has a lower surface coupled to the upper surface of the piezoelectric layer 504.These surfaces can be flat, or they can be undulating in the direction of the major axis of the first bone plate and / or the minor axis of the first bone plate.The surface can be another non-planar shape, and is configured so that the force applied to bone plates 502 and 506 causes the piezoelectric layer 504 to have a non-planar shape. Such non-planar shapes include undulations, waves, zigzags, curves, bends, corners or creases in any direction. Other embodiments within the present disclosure are also disclosed that may also have these features. The surfaces may be smooth, or they may include any number of sharp features. The piezoelectric layer 504 also has a lower surface that is coupled to the upper surface of the second bone plate 506. These surfaces may be flat, or they may undulate in the direction of the long axis of the second bone plate and / or the short axis of the second bone plate. The surfaces may be smooth, or they may include any number of sharp features. The first bone plate 502 and the second bone plate 506 may be made of conductive materials, insulating materials, and combinations thereof. The piezoelectric layer 504 is configured to generate an electrical output corresponding to a load (e.g., an anatomical load) borne by the piezoelectric layer.

[0075] Figure 6 Implant assembly according to an embodiment of the present invention is shown.Implant assembly 600 comprises bone plate 602, and this bone plate is configured to be coupled to the bone 612 of fracture.Bone plate 602 has one group of screw thread or threadless opening 608, and opening 608 is configured to use with fasteners such as lag screw 606 to fix implant assembly 600 to bone 612.At least one in opening 608 has piezoelectric ring 604 that is arranged in opening 608.Piezoelectric ring 604 is configured to produce the corresponding electrical output of the load (for example anatomical load) that is borne with piezoelectric ring.Piezoelectric ring 604 illustratively can be made of PVDF.

[0076] Figure 7Described implant assembly according to an embodiment of the present invention.The bone plate 602 of implant assembly 600 is fixed to bone 612 by lag screw 606 or other types of fasteners.At least one piezoelectric ring 604 is arranged in a corresponding opening 608, so that lag screw 606 is screwed in the bone 612 and in electrical contact with piezoelectric ring 604 by opening 608.Bone plate 602 and / or lag screw 606 are made of conductive material.In this example, the energy that bone plate 602 and lag screw 606 produce piezoelectric ring 604 is transferred to the bone 612.By changing the length of lag screw, screw 606 can be selected to be electrically transferred to the zone of bone 612.

[0077] Figure 8 Another view of an implant assembly 600 according to an embodiment of the present invention is shown. As described above, the bone plate 602 and lag screw 606 transmit energy generated by the piezoelectric ring 604 into the bone 612 in the area of ​​the fracture site 610 to stimulate bone growth.

[0078] Fig. 9 An implant assembly according to an embodiment of the present invention is shown.Implant assembly 900 comprises bone plate 902, which is configured to be coupled to the bone of a fracture.Bone plate 902 has a set of threaded or threadless openings 908, and opening 908 is configured to be used together with lag screw 906 or other types of fasteners, so that implant assembly 900 is fixed to bone.At least one of the openings 908 has a piezoelectric ring 904 arranged in the opening 908.Piezoelectric ring 904 is configured to produce an electrical output corresponding to the load (such as anatomical load) borne by the piezoelectric ring.Piezoelectric ring 904 can be made of PVDF illustratively.Piezoelectric ring 904 is arranged on an insulating ring 905 made of insulating material.The electrical transmission that insulating ring 905 stops piezoelectric ring 904 from producing is transmitted to bone plate 902.

[0079] Fig.10 Described another view of implant assembly 900 according to an embodiment of the present invention.Implant assembly 900 is fixed to the bone 912 of fracture in the region across fracture site 910.The electric energy that piezoelectric ring 904 produces is transferred to bone 912 by lag screw 906 (or another type of fastener) made of conductive material.Insulating ring 905 prevents electric energy from being transferred to bone plate 902, makes electric charge concentrate on fracture by one group of lag screw 906.

[0080] Fig.11An interspinous fixation plate according to an embodiment of the present invention is shown. The interspinous fixation plate 1100 includes a first end plate 1102, a second end plate 1122 (which is coupled to the first end plate through a central tube 1106) and at least one layer of piezoelectric material. In this embodiment, the implant 1100 includes a first layer of piezoelectric material 1104 and a second layer of piezoelectric material 1124. The first layer of piezoelectric material 1104 is disposed on the first end plate 1102 and faces the central tube 1106. The second layer of piezoelectric material 1124 is disposed on the second end plate 1122 and faces the central tube 1106. Exemplarily, the components of the implant 1100 can be connected together using a set of tantalum screws (not shown), which are excellent conductors. However, it should be understood that any other suitable material, structure or method can be used to connect the components, such as tantalum rods, saturation or dispersion, coatings, rivets, adhesives, friction fits, swing locks, or combinations thereof.

[0081] The first end plate 1102 and the second end plate 1122 are typically made of titanium or other suitable materials. The end plates may include a plurality of teeth having a height ranging from 0.5 mm to 5 mm and protruding vertically from the outer surface of the plate. The teeth are configured to engage with the spinous process, thereby fixing or fastening the implant 1100 to the spinous process. The central cylinder 1106 may be made of a suitable polymer material, such as polyetheretherketone (PEEK), which is an excellent insulator that can insulate the current generated by the piezoelectric material and provide visibility for postoperative assessment. However, it is also clearly envisioned that the central cylinder 1106 may be made of a piezoelectric material, such as PVDF. The first layer of piezoelectric material 1104 and the second layer of piezoelectric material 1124 are made of PVDF film or other piezoelectric material and are disposed between each end plate 1102, 1122 and the central cylinder 1106. Layers 1104 and 1124 are typically molded into the shape of the surface between which they are located. The first layer of piezoelectric material 1104 and the second layer of piezoelectric material 1124 are configured to generate an electrical output corresponding to the load (e.g., anatomical load) to which the corresponding piezoelectric layer is subjected. One or both of the surfaces of the central barrel 1106 facing the piezoelectric layer can be contoured to increase the electrical output generated by the piezoelectric layer and / or the central barrel.

[0082] Fig.12 A dynamic interspinous plate according to an embodiment of the present invention is shown. The interspinous fixation plate 1200 includes a first end plate 1202 and a second end plate 1222. The first end plate 1202 is coupled to the second end plate 1222 via a central tube 1224. The first end plate 1202 and the second end plate 1222 may be made of titanium or other suitable materials. At least one of the first end plate 1202 and the second end plate 1222 may not have teeth to maintain the movement of the interspinous fixation plate 1200 relative to the spinous processes and / or vertebrae of the spine. Alternatively, the first end plate and the second end plate may have teeth as described above with reference to Fig.11The central cylinder 1224 is made of PVDF or other piezoelectric material and is configured to generate an electrical output corresponding to the load (eg, anatomical load) experienced by the implant.

[0083] Fig.13A A pedicle screw assembly according to an embodiment of the present invention is shown. A pedicle screw 1300 is configured to be screwed into a vertebra. The pedicle screw 1300 has a head 1302, a neck, and a body 1306. The head 1302 is coupled to the body 1306 via the neck. To this end, the neck can, for example, be attached to the body and can be threaded so that the head can be screwed onto the neck and thereby coupled to the body. The body 1306 is configured to be screwed into a vertebra. The head 1302 also includes an opening through which the screw 1300 can be attached to a rod, such as Fig. 13B As shown. The piezoelectric layer 1304 is disposed on the neck. The piezoelectric layer 1304 can be made of PVDF or other piezoelectric materials and is configured to generate an electrical output corresponding to the load (e.g., anatomical load) borne by the pedicle screw. The neck and / or body of the pedicle screw 1300 are made of a conductive material so that the electrical output from the piezoelectric layer 1304 is transmitted to the vertebra through the neck and body of the pedicle screw 1300. The head 1302 can also be made of a conductive material and electrically coupled to the neck and body.

[0084] Fig. 13B A pedicle screw assembly 1350 is shown in accordance with an embodiment of the present invention. A plurality of pedicle screws 1352 are configured similarly to the pedicle screws 1300 described above and are connected by a rod 1360. The rod 1360 is coated with a layer of PVDF or other piezoelectric material and is configured to enhance posterior fusion of the vertebra to which the assembly 1350 is coupled. Fig.13A As described, each pedicle screw 1352 also includes a neck, on which a PVDF layer or other piezoelectric material is disposed. Rod 1360 is configured to generate an electrical output corresponding to a load (e.g., an anatomical load) borne by the rod. The electrical output generated by rod 1360 is transmitted to multiple screws 1352 and transmitted to the vertebrae through the screws.

[0085] Fig.14 A pedicle screw assembly according to an embodiment of the present invention is shown. A pedicle screw 1400 is configured to be screwed into a vertebra. The pedicle screw 1400 has a head 1402, a rod saddle 1408, a screw head saddle 1410, and a body 1406. The head 1402 is coupled to the body 1406 via the rod saddle 1408 and the screw head saddle 1410. The body 1406 is configured to be screwed into a vertebra. The head 1402 also includes an opening through which the screw 1400 can be attached to a rod, as described above. Fig. 13B. The piezoelectric layer 1404 is disposed between the rod saddle 1408 and the screw head saddle 1410. The piezoelectric layer 1404 can be made of PVDF or other piezoelectric materials and is configured to generate an electrical output corresponding to the load (e.g., anatomical load) to which the pedicle screw is subjected. The neck and body of the pedicle screw 1400 can also be made of a conductive material so that the electrical output from the piezoelectric layer 1404 is transmitted to the vertebra through the screw head saddle and body of the pedicle screw 1400. The head 1402 can also be made of a conductive material and electrically coupled to the rod saddle so that the electrical output from the piezoelectric layer 1404 is transmitted to the attached rod through the rod saddle and the head. The rod saddle 1408 has a contoured underside to drive the electrical output of the piezoelectric layer 1404. Similarly, the screw head saddle 1410 has a contoured top surface to drive the electrical output of the piezoelectric layer 1404. Fig.14 Also shown is a standard pedicle screw assembly 1450 that includes a standard rod saddle 1452.

[0086] Fig.15 A pedicle screw assembly according to an embodiment of the present invention is shown. The pedicle screw 1500 has a head 1502, a body 1506, a screw head saddle 1510 and a piezoelectric layer 1504. These elements should be understood to be the same as those described above with reference to Fig.14 The elements shown and described are substantially the same. In addition, the pedicle screw 1500 has an insulator 1505. The insulator is located between the piezoelectric layer 1504 and the head 1502 and electrically insulates the head 1502 from the piezoelectric layer 1504. Thus, the electrical output from the piezoelectric layer 1504 is transmitted only to the body of the pedicle screw and not to the head 1502 or any rod attached to the head.

[0087] Fig.16 A pedicle screw assembly according to an embodiment of the present invention is shown. The pedicle screw 1600 has a head 1602, a body 1606, a rod saddle 1608 and a piezoelectric layer 1604. These elements should be understood to be the same as those described above with reference to Fig.14 The elements shown and described are substantially the same. In addition, the pedicle screw 1600 has an insulator 1605. The insulator is located between the piezoelectric layer 1604 and the body 1606 and electrically insulates the body 1606 from the piezoelectric layer 1604. Thus, the electrical output from the piezoelectric layer 1604 is transmitted only to the head 1602 of the pedicle screw and any rods attached to the head, and not to the body 1606 or the vertebrae.

[0088] Fig.17Joint implant assembly 1700 according to an embodiment of the present invention is shown. Although knee joint implant is shown and described, it is clearly envisioned that implant assembly 1700 can be configured for other joints, such as hip joint or ankle joint. Knee joint implant assembly 1700 in this example comprises femoral implant 1708 and tibial implant with platform 1706. Tibial implant also comprises piezoelectric layer 1704 and friction surface 1702. Piezoelectric layer 1704 is made of PVDF or other piezoelectric materials, and is configured to produce the corresponding electrical output of the load (such as anatomical load) borne by joint implant assembly 1700. The tibial implant on which piezoelectric layer 1704 is arranged can be made of conductive material, such as titanium, and it transmits electrical output to bone. The surface of the lower side of friction surface 1702 and / or tibial platform 1706 is contoured to drive the electrical output of piezoelectric layer 1704.

[0089] Fig.18 An intramedullary nail assembly according to an embodiment of the present invention is shown. The intramedullary nail assembly 1800 includes an upper shaft 1806 and a lower shaft 1808. The upper shaft and the lower shaft can be made of titanium or other suitable implant materials. The upper shaft 1806 includes a pin 1814, which is configured to connect the upper shaft to the lower shaft. The intramedullary nail assembly 1800 also includes an electrical conductor 1802 disposed between the upper shaft and the lower shaft. The electrical conductor 1802 is advantageously positioned to span a fracture site 1820 in a bone 1822 in which the intramedullary nail assembly is implanted. A first piezoelectric ring 1804 is disposed between the electrical conductor 1802 and the upper shaft 1806, and a second piezoelectric ring 1805 is disposed between the electrical conductor 1802 and the lower shaft 1808. The first and second piezoelectric rings can be made of PVDF or other piezoelectric materials and are configured to generate an electrical output corresponding to a load (e.g., an anatomical load) borne by the respective rings. The electrical outputs of the first and second piezoelectric rings are transmitted to the fractured bone 1822 in the region of the fracture site 1820 through the electrical conductor 1802 to promote bone growth and healing of the fracture. The upper shaft 1806 also has an upper insulating cap 1810 that is contoured to deform the first piezoelectric ring 1804 and drive its electrical output. The upper insulating cap 1810 is also configured to insulate the upper shaft 1806 from the electrical conductor 1802. The lower shaft 1808 similarly has a lower insulating cap 1812 that is contoured to deform the second piezoelectric ring 1805 and drive its electrical output. The lower insulating cap 1812 is also configured to insulate the lower shaft 1808 from the electrical conductor 1802.

[0090] Fig.19 Another view of the intramedullary nail assembly 1800 is shown. As can be seen, the first piezoelectric ring 1804 and the second piezoelectric ring 1805 conform to the contours of the upper insulating cap 1810 and the lower insulating cap 1812, respectively.

[0091] Fig. 201800. The pin 1814 of the upper shaft 1806 is inserted into the pin hole 1815 in the lower shaft 1808 to connect the upper shaft to the lower shaft. The electrical conductor 1802 is located between the upper shaft 1806 and the lower shaft 1808. The electrical conductor 1802 also has a pin hole that is configured to receive the pin 1814 of the upper shaft. In other words, the pin 1814 extends from the upper shaft 1806 through the electrical conductor 1802 into the lower shaft 1808. The first piezoelectric ring 1804 is arranged between the upper shaft (and its upper insulating cap) and the electrical conductor. The second piezoelectric ring 1805 is arranged between the lower shaft (and its lower insulating cap) and the electrical conductor.

[0092] Fig.21 A bone screw assembly according to an embodiment of the present invention is shown. Bone screw 2100 includes a screw head 2102 connected to a screw body 2106. Head 2102 includes a washer 2104. Washer 2104 can be made of a piezoelectric material, or can include a piezoelectric layer disposed on the washer. The piezoelectric material can be PVDF, or other piezoelectric material, and is configured to generate an electrical output corresponding to a load (e.g., an anatomical load) borne by the washer. The electrical output generated by the piezoelectric material is transmitted to the bone through the screw body 2106. The screw head 2102 can be smooth, or can have undulations to enhance the electrical output generated by the piezoelectric material.

[0093] Fig. 22 Hip replacement assembly according to an embodiment of the present invention is shown. Hip replacement assembly 2200 includes acetabular component 2202, insulating liner 2206 (e.g., made of plastic), femoral head 2208, and femoral stem 2210. Acetabular component 2202 is configured to be attached to the acetabulum of the hip bone, and includes acetabular piezoelectric layer 2204, which is arranged on the joint surface of acetabular component 2202 facing away from the hip bone. When implanting hip replacement assembly 2200, this arrangement allows femoral head 2208 to generate load on the joint surface of acetabular component, thereby generating load on acetabular piezoelectric layer. Acetabular piezoelectric layer 2204 is made of PVDF or other piezoelectric materials, and is configured to generate an electrical output corresponding to the load (e.g., anatomical load) borne by hip replacement assembly 2200. Then insulating liner 2206 is arranged on acetabular piezoelectric layer 2204. Acetabular component 2202 is made of conductive material so that the electrical output generated by acetabular piezoelectric layer 2204 is transmitted to the hip bone. The insulating layer 2206 can be replaced by a piezoelectric layer that is configured to generate an electrical output corresponding to the load (e.g., anatomical load) experienced by the hip replacement component.

[0094] The femoral head 2208 is rigidly coupled to a femoral stem 2210. The femoral stem 2210 is configured to be implanted in a femur and includes a femoral piezoelectric layer 2212. The femoral piezoelectric layer 2212 is made of PVDF or other piezoelectric material and is configured to generate an electrical output corresponding to a load (e.g., an anatomical load) experienced by the hip replacement assembly 2200. The femoral stem 2210 is made of a conductive material so that the electrical output generated by the femoral piezoelectric layer 2212 is transmitted into the femur.

[0095] Fig.23 A bone spacer assembly according to an embodiment of the present invention is shown, which can also be a bone void filler. Bone void fillers can be used to treat bone defects or alignment, including bone defects or alignment at the foot, ankle, hand, wrist, spine, etc. Bone spacer assembly 2300 includes a top end plate 2302 and a bottom end plate 2310. The top end plate and the bottom end plate can be made of titanium. The top end plate and the bottom end plate can also be 3D printed. Bone spacer assembly 2300 also includes a first piezoelectric layer 2304 and a second piezoelectric layer 2308. The first and second piezoelectric layers can be made of PVDF or other piezoelectric materials and are configured to generate an electrical output corresponding to the load (e.g., anatomical load) borne by the bone spacer assembly 2300. Bone spacer assembly 2300 also includes an insulator 2306, which can be made of polyetheretherketone (PEEK). The bone spacer assembly 2300 is assembled with the second piezoelectric layer 2308 disposed on the bottom end plate 2310, the insulator 2306 disposed on the second piezoelectric layer 2308, the first piezoelectric layer 2304 disposed on the insulator 2306, and the top end plate 2302 disposed on the first piezoelectric layer 2304. A set of assembly pins 2312 secure the components of the bone spacer assembly 2300 together.

[0096] Insulator 2306 has contoured top and bottom surfaces to drive the output of the piezoelectric layer. Top end plate 2302 has a contoured bottom surface that matches the top surface of insulator 2306. Bottom end plate 2310 has a contoured top surface that matches the bottom surface of insulator 2306. Piezoelectric layers 2304 and 2308 are sandwiched between the contoured surfaces. The contouring deforms the piezoelectric layer to increase the strain under compressive loads, thereby increasing the electrical output.

[0097] Instead of sandwiching an insulator and two piezoelectric layers between the top and bottom end plates as described above, it is expressly contemplated that only a single piezoelectric layer may be sandwiched between the top and bottom end plates. In this embodiment, the contoured bottom surface of the top end plate matches the contoured top surface of the bottom end plate. The piezoelectric layer is then sandwiched between the contoured surfaces, which deforms the piezoelectric layer to increase strain under compressive loads, thereby increasing electrical output.

[0098] Fig.24 and Fig.25A method of assembling a bone spacer assembly (e.g., bone spacer assembly 2300) according to an embodiment of the present invention is shown. In step 2410, the top and bottom end plates are 3D printed without pin holes. The end plates, piezoelectric layers, and insulators are then assembled as described above with reference to Fig.23 Pressure is applied to the top and bottom of the bone spacer assembly to force the piezoelectric layer to conform to the internal contours.

[0099] In step 2420, a precision hole for assembly pin 2312 is drilled while the assembly is still in a compressed state. Drilling while the assembly is in a compressed state ensures that the hole is drilled through both the top end plate and the bottom end plate to ensure perfect alignment. In step 2430, the assembly is disassembled and the hole in the bottom end plate is expanded to form an expanded hole 2314. The top border of the expanded hole 2314 remains in the same vertical position as the drilled hole to ensure that the bone spacer assembly remains in a compressed state when reassembled.

[0100] In step 2440, the bone spacer assembly is reassembled and compressed so that the drilled holes in the top end plate are aligned with the expanded holes in the bottom end plate. In step 2450, the pins 2312 are inserted to keep the bone spacer assembly in a compressed state. The expanded holes 2314 ensure that the bone spacer assembly 2300 can be compressed more when subjected to load to allow the first and second piezoelectric layers to generate electrical output.

[0101] Fig.26 The mechanism of activating PVDF or other piezoelectric materials according to an embodiment of the present invention is shown. As mentioned above, piezoelectric materials are known to have different response levels depending on the direction and magnitude of the applied force. Stress is usually decomposed into directional components and described by a 3x 3 "Cauchy stress tensor" matrix, where d11, d22 and d33 are axial compressions along the x-axis, y-axis and z-axis respectively.

[0102] The matrix entries at the top right and bottom left of the matrix are d31 and d13 and represent in-plane shear stresses. One favorable mechanism for activating piezoelectric materials is to transfer compressive loads to the d31 displacement mode to increase the electrical output. For some piezoelectric materials, such as the treated PVDF in several examples herein, the piezoelectric constant for d31 can be more than double that for the other directions. For a given load scenario, this increase in the amplitude of the electrical signal is highly desirable and can have a meaningful impact on the performance of the final product.

[0103] Fig. 27 Piezoelectric knee implants (e.g., Fig.17 The piezoelectric layer 1704 generates an electrical output that is received by one or more bones.

[0104] Fig.28 Piezoelectric implant components (e.g., Figure 1 2808).Bone plate 102 is equipped with piezoelectric cover 104, and is fixed to bone 2808 by screw 2806, spans fracture site 2810.The force applied by screw and optional other forces make piezoelectric cover 104 produce electrical output (shown by lightning icon), and this electrical output is by bone 2808 (shown by light bulb icon).

[0105] The embodiments of the present invention described above are intended to be exemplary only; it will be apparent to those skilled in the art that various changes and modifications may be made. All of these changes and modifications should fall within the scope of the present invention as defined by any of the appended claims.

Claims

1. An orthopedic implant assembly comprising: A bone plate configured to couple the implant assembly to a fractured bone; as well as a piezoelectric layer disposed on the bone plate and configured to generate an electrical output corresponding to a load borne by the piezoelectric layer, Wherein, when the piezoelectric layer contacts the fractured bone, the electrical output is transmitted to the fractured bone.

2. The orthopedic implant assembly according to claim 1, wherein: The fractured bone is selected from the group consisting of a femur, a tibia, a fibula, a humerus, an ulna, a radius, a vertebra, bones of the shoulder joint, bones of the hip joint, and bones of the ankle joint.

3. The orthopedic implant assembly according to claim 1, wherein: The load is an anatomical load.

4. The orthopedic implant assembly according to claim 1, wherein: The piezoelectric layer includes polyvinylidene fluoride and / or polyvinylidene fluoride (PVDF).

5. The orthopedic implant assembly according to claim 1, wherein: The piezoelectric layer includes a lip configured to wrap around an underside of the bone plate.

6. The orthopedic implant assembly according to claim 1, wherein: The bone plate includes a groove configured to receive the piezoelectric layer.

7. The orthopedic implant assembly according to claim 6, wherein: The bone plate also includes a set of fasteners configured to secure the piezoelectric layer in the slot.

8. The orthopedic implant assembly according to claim 1, wherein: The piezoelectric layer has a ribbon shape and is configured to wrap around the bone plate at a fracture site.

9. The orthopedic implant assembly according to claim 1, wherein: The bone plate has a bottom surface with an undulation, wherein the piezoelectric layer is disposed on the bottom surface of the bone plate, and wherein the undulating bottom surface is configured to compress the piezoelectric layer so as to drive the electrical output of the piezoelectric layer.

10. An orthopedic implant assembly comprising: A first bone plate having a shape suitable for coupling a first side of the implant assembly to a fractured bone and having an undulating second side; a piezoelectric layer disposed between the first bone plate and the second bone plate and configured to generate an electrical output corresponding to a load borne by the piezoelectric layer; as well as The second bone plate is disposed on the piezoelectric layer and has an undulating lower side, wherein the piezoelectric layer is compressed between the undulating second side of the first bone plate and the undulating lower side of the second bone plate; and Wherein, when at least one of the first bone plate and the second bone plate contacts the fractured bone, the electrical output is transmitted to the fractured bone.

11. The orthopedic implant assembly according to claim 10, wherein: The fractured bone is selected from the group consisting of a femur, a tibia, a fibula, a humerus, an ulna, a radius, a vertebra, bones of the shoulder joint, bones of the hip joint, and bones of the ankle joint.

12. The orthopedic implant assembly according to claim 10, wherein: A material of each of the first bone plate and the second bone plate is selected from the group consisting of: a conductive material, a non-conductive material, and a combination thereof.

13. The orthopedic implant assembly according to claim 10, wherein: The load is an anatomical load.

14. The orthopedic implant assembly according to claim 10, wherein: The piezoelectric layer includes polyvinylidene fluoride and / or polyvinylidene fluoride (PVDF).

15. An orthopedic implant assembly comprising: A bone plate having a shape suitable for coupling the implant assembly to a fractured bone and having a set of openings; a set of piezoelectric rings, each ring in the set of piezoelectric rings disposed in one of the set of openings and configured to generate an electrical output corresponding to a load experienced by the ring; as well as a set of fasteners, each fastener being disposed in one of the set of openings so as to protrude into the fractured bone, Wherein, the set of fasteners is configured to transmit the electrical output to the fractured bone.

16. The orthopedic implant assembly of claim 15, wherein: The fractured bone is selected from the group consisting of a femur, a tibia, a fibula, a humerus, an ulna, a radius, a vertebra, bones of the shoulder joint, bones of the hip joint, and bones of the ankle joint.

17. The orthopedic implant assembly of claim 15, wherein: The material of the bone plate is an electrically conductive material, and wherein the bone plate is configured to transmit the electrical output to the fractured bone.

18. The orthopedic implant assembly of claim 15, further comprising a set of insulating rings, each insulating ring being disposed between a corresponding piezoelectric ring and a corresponding opening, wherein the material of each fastener in the set of fasteners is a conductive material so that the electrical output is transmitted to the fractured bone only through the fasteners.

19. The orthopedic implant assembly of claim 15, wherein: The load is an anatomical load.

20. The orthopedic implant assembly of claim 15, wherein: The piezoelectric layer includes polyvinylidene fluoride and / or polyvinylidene fluoride (PVDF).

21. An interspinous plate for a vertebra, comprising: a first end plate; a second end plate; as well as a central tube disposed between and coupled to the first end plate and the second end plate, wherein at least one of the first end plate and the second end plate comprises a piezoelectric layer disposed on the end plate, the piezoelectric layer being configured to generate an electrical output corresponding to a load borne by the piezoelectric layer; Wherein, the central tube is made of insulating material; and Wherein the interspinous plate is configured to couple to the spinous process of the vertebra and is further configured to transmit the electrical output into the spinous process.

22. The interspinous plate according to claim 21, wherein At least one of the first endplate and the second endplate includes a plurality of teeth configured to engage the spinous processes.

23. The interspinous plate according to claim 21, wherein The piezoelectric layer includes polyvinylidene fluoride and / or polyvinylidene fluoride (PVDF).

24. The interspinous plate according to claim 21, wherein A surface of the central tube facing the piezoelectric layer has undulations, and the undulating surface of the central tube is configured to compress the piezoelectric layer so as to drive the electrical output of the piezoelectric layer.

25. An interspinous plate for a vertebra, comprising: a first end plate; a second end plate; as well as a central tube disposed between and coupled to the first end plate and the second end plate, wherein the central tube is made of piezoelectric material and is configured to generate an electrical output corresponding to a load borne by the central tube; and Wherein the interspinous plate is configured to couple to the spinous process of the vertebra and is further configured to transmit the electrical output into the spinous process.

26. The interspinous plate according to claim 25, wherein At least one of the first endplate and the second endplate includes a plurality of teeth configured to engage the spinous processes.

27. A pedicle screw assembly comprising: a body configured to be screwed into a vertebra; a screw head saddle, disposed on the main body; a piezoelectric layer disposed on the screw head saddle and configured to generate an electrical output corresponding to a load experienced by the pedicle screw assembly; A rod saddle, disposed on the piezoelectric layer; as well as The head, set to the rod saddle, Wherein, the rod saddle has a contoured underside and the screw head saddle has a contoured top surface, the contoured underside and the contoured top surface are configured to compress the piezoelectric layer so as to drive the electrical output of the piezoelectric layer.

28. The pedicle screw assembly of claim 27, wherein: The rod saddle is an insulator.

29. The pedicle screw assembly of claim 27, wherein: The screw head saddle is an insulator.

30. A pedicle screw assembly comprising: a plurality of pedicle screws, each pedicle screw having a head, a neck, and a body; a rod coupled to the head of each of the plurality of pedicle screws; a plurality of piezoelectric layers, each layer disposed at the neck of a corresponding one of the plurality of pedicle screws and configured to generate an electrical output corresponding to a load experienced by the screw and the rod, Wherein the body of each pedicle screw is configured to be screwed into a vertebra and is further configured to transmit the electrical output to the vertebra.

31. The pedicle screw assembly of claim 30, further comprising: A piezoelectric rod layer is disposed on the rod and is configured to generate an additional electrical output corresponding to the load experienced by the screw and the rod.

32. The pedicle screw assembly of claim 30, wherein: The load is an anatomical load.

33. The pedicle screw assembly of claim 30, wherein: The piezoelectric layer includes polyvinylidene fluoride and / or polyvinylidene fluoride (PVDF).

34. A knee joint implant assembly comprising: a tibial implant configured to couple to a tibia, and A femoral implant configured to couple to a femur, wherein the tibial implant includes a piezoelectric layer disposed on the implant and configured to generate an electrical output corresponding to a load borne by the implant, Wherein, the knee implant component is configured to transmit the electrical output into the tibia.

35. The knee implant assembly of claim 34, wherein: The tibial implant has an undulating upper surface, the piezoelectric layer is disposed on the undulating upper surface, the undulating upper surface is configured to compress the piezoelectric layer so as to drive the electrical output of the piezoelectric layer.

36. The knee implant assembly of claim 34, wherein: The piezoelectric layer includes polyvinylidene fluoride and / or polyvinylidene fluoride (PVDF).

37. An intramedullary nail assembly, comprising: a lower shaft having a lower insulating cap; a first piezoelectric ring disposed on the lower insulating cap and configured to generate an electrical output corresponding to a load borne by the intramedullary nail assembly; An electric conductor, disposed on the first piezoelectric ring; a second piezoelectric ring disposed on the electrical conductor and configured to generate an electrical output corresponding to a load experienced by the intramedullary nail assembly; as well as an upper shaft, disposed on the second piezoelectric ring and having an upper insulating cap, Wherein, the lower insulating cap has a contoured top surface and the upper insulating cap has a contoured underside, and the contoured underside and the contoured top surface are configured to compress the first piezoelectric ring and the second piezoelectric ring so as to drive the electrical outputs of these piezoelectric rings.

38. The intramedullary nail assembly of claim 37, wherein: The piezoelectric layer includes polyvinylidene fluoride and / or polyvinylidene fluoride (PVDF).

39. An intramedullary screw assembly, comprising: a body, configured to be coupled to the skeleton; head; as well as A washer is provided with a piezoelectric layer therein, wherein the piezoelectric layer is configured to generate an electrical output corresponding to a load borne by the intramedullary screw assembly.

40. The intramedullary screw assembly of claim 39, wherein: The head has a relief configured to drive the electrical output of the piezoelectric layer.

41. The intramedullary nail assembly of claim 39, wherein: The piezoelectric layer includes polyvinylidene fluoride and / or polyvinylidene fluoride (PVDF).

42. A hip replacement assembly comprising: an acetabular component configured to be coupled to an acetabulum, wherein an acetabular piezoelectric layer is disposed on an articular surface of the acetabular component, the acetabular piezoelectric layer being configured to generate a first electrical output corresponding to a load borne by the acetabular piezoelectric layer; An insulating liner, disposed on the acetabulum piezoelectric layer; a femoral component configured to be coupled to a femur and comprising a femoral head and a femoral stem; a femoral piezoelectric layer disposed on the femoral stem and configured to generate a second electrical output corresponding to a load borne by the femoral piezoelectric layer, wherein the acetabular component is configured to transmit the first electrical output into the acetabulum; and Wherein the femoral component is configured to transmit the second electrical output into the femur.

43. The hip replacement assembly of claim 42, wherein: The acetabular piezoelectric layer and the femoral piezoelectric layer include polyvinylidene fluoride and / or polyvinylidene fluoride (PVDF).

44. A bone spacer assembly comprising: a bottom end plate having a contoured top surface; a first piezoelectric layer disposed on the bottom end plate and configured to generate a first electrical output corresponding to a load borne by the first piezoelectric layer; Top end plate with contoured bottom surface, Wherein the contoured top surface of the bottom end plate and the contoured bottom surface of the top end plate are configured to compress the first piezoelectric layer so as to drive an electrical output of the first piezoelectric layer.

45. The bone spacer assembly of claim 44, further comprising: an insulator disposed on the first piezoelectric layer and having a contoured top surface and a contoured bottom surface; a second piezoelectric layer disposed on the insulator and configured to generate a second electrical output corresponding to a load borne by the second piezoelectric layer; Wherein the contoured top surface of the insulator and the contoured bottom surface of the top end plate are configured to compress the second piezoelectric layer so as to drive an electrical output of the second piezoelectric layer.

46. ​​The bone spacer assembly of claim 44, wherein: Each of the top end plate, the second piezoelectric layer, the insulator, and the first piezoelectric layer has a central groove, and wherein the bottom end plate has a raised central portion, the raised central portion being configured to protrude through the central groove of the first piezoelectric layer, the insulator, the second piezoelectric layer, and the top end plate.

47. The bone spacer assembly of claim 45, further comprising: A set of assembly pins, wherein the top end plate has a set of pin holes and the raised central portion of the bottom end plate has a set of extension holes corresponding to the set of pin holes, so that each of the set of assembly pins protrudes through one pin hole in the set of pin holes and a corresponding one extension hole in the set of extension holes.

48. A method for manufacturing an implant, comprising: compressing a first piezoelectric film between a bottom surface of a top end plate and a top surface of an insulator, wherein the bottom surface of the top end plate and the top surface of the insulator have undulations, and wherein, by applying pressure, the first piezoelectric film conforms to the undulations; compressing a second piezoelectric film between a bottom surface of the insulator and a top surface of the bottom end plate, wherein the bottom surface of the insulator and the top surface of the bottom end plate have undulations, and wherein, by applying pressure, the second piezoelectric film conforms to the undulations; drilling a set of pin holes through the top end plate and the bottom end plate; expanding the set of pin holes of the bottom end plate to create expanded holes such that top boundaries of the expanded holes align with top boundaries of the pin holes of the top end plate; and A set of assembly pins are inserted through the pin holes of the top end plate and the expansion holes of the bottom end plate so that the first piezoelectric film is compressed and the second piezoelectric film is compressed and remains compressed.

49. A method for manufacturing an implant, comprising: compressing a piezoelectric film between a bottom surface of a top end plate and a top surface of a bottom end plate, wherein the bottom surface of the top end plate and the top surface of the bottom end plate have undulations, and wherein, by applying pressure, the piezoelectric film conforms to the undulations; drilling a set of pin holes through the top end plate and the bottom end plate; expanding the set of pin holes of the bottom end plate to create expanded holes such that top boundaries of the expanded holes align with top boundaries of the pin holes of the top end plate; and A set of assembly pins are inserted through the pin holes of the top end plate and the expanded holes of the bottom end plate so that the piezoelectric film is held in compression.

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