INTELLIGENT IMPLANT AND ASSOCIATED ANTENNA AND DATA SAMPLING METHODS - Patent application

Abstract

The intelligent implant includes components of the implanted prosthesis and an implanted reporting processor (IRP) associated with the implanted prosthesis. The IRP includes a housing having a casing and a cover coupled to the casing, an electronics assembly within the housing, and an antenna within the housing and coupled to the electronics assembly. The antenna is tuned and the electronics assembly is configured to enable communication through the antenna at both 2.45 GHz and 403 MHz (MICS channels). The antenna comprises a flat ribbon configured in a loop and having a major surface. The antenna is enclosed within and oriented within the cover of the housing, with the major surface of the antenna generally parallel to an inner surface of the cover.

Description

[Technical field]

[0001] The present disclosure generally involves orthopedic (e.g., joint) replacement systems, and more specifically, intelligent implants with implantable report processors that record and transmit information regarding the placement and integrity of the implanted system and the health of the patient in which the system is implanted, as well as features of the intelligent implants including enhanced transmit antenna configurations and data sampling methods.

[0002] Incorporation by reference of any preferred use All applications filed with this application for which a foreign or domestic priority claim is identified in an Application Data Sheet are hereby incorporated by reference. [Background technology]

[0003] Orthopaedic replacement systems, such as knee, shoulder, and hip arthroplasty systems, may be configured to replace the entire knee, shoulder, or hip joint, or to replace a portion of the knee, shoulder, or hip joint. Systems intended to replace the entire knee, shoulder, or hip joint are referred to as total joint replacement systems or total joint arthroplasties (TJA), while systems intended to replace a portion of a joint are referred to as partial joint replacement systems. In either case, these joint replacement systems include an implant structure or component.

[0004] As shown in FIG. 1A, a total knee arthroplasty (TKA) typically consists of a femoral component, a tibial component, a tibial insert, a tibial stem extension, and a patellar component. The patellar component, which is implanted in the anterior part of the joint, is not shown. Collectively, these five implant structures or components may be referred to as any one of an implantable medical device, a knee prosthesis system, or a total knee arthroplasty (TKI). Each of these five components may also be individually referred to as an implantable medical device. In either case, these components are designed to work together as a functional unit to replace and provide the function of a natural knee joint.

[0005] As shown in FIG. 1B, a standard total shoulder arthroplasty (TSA) typically consists of a humeral stem component, a humeral stem adaptor, a humeral head, a humeral head adaptor (not shown), and a glenoid cap component. Collectively, these four implant structures or components may be referred to as any one of an implantable medical device, a prosthetic shoulder system, or a total shoulder arthroplasty (TSI). Each of these four components may also be individually referred to as an implantable medical device. In either case, these components are designed to work together as a functional unit to replace and provide the functions of the natural shoulder joint.

[0006] As shown in FIG. 1C, a total hip arthroplasty (THA) typically consists of a femoral stem component, a femoral head component, a head liner component, and an acetabular cap component. Collectively, these four implant structures or components may be referred to as any one of an implantable medical device, a hip prosthesis system, or a hip prosthesis implant (THI). Each of these four components may also be individually referred to as an implantable medical device. In either case, these components are designed to work together as a functional unit to replace and provide the function of a natural hip joint.

[0007] Current commercially available TJA systems have a long history of clinical use, with implant durations regularly exceeding 10 years, with some reports supporting 87% survival at 25 years. Clinicians currently monitor the progress of TJA patients after implantation using a series of physical examinations at 2-3 weeks, 6-8 weeks, 3 months, 6 months, 12 months, and annually thereafter.

[0008] After the TJA is implanted and the patient begins to walk with the knee or hip prosthesis and move the arm or shoulder prosthesis, problems may occur and be difficult to identify. Clinical examinations are often limited in their ability to detect denture failures, so additional monitoring is often required, such as CT scans, MRI scans, or nuclear scans. Given the range of treatment requirements over the life of the implant, patients are encouraged to visit their clinician annually to check their health, monitor other joints, and evaluate the function of the TJA implant. While the current standard of care gives clinicians and health systems the ability to assess patients' TJA function during a 90-day episode of care, measurements are subjective and often lack the time resolution to depict small changes in function that may be precursors to larger mobility problems. Long-term (>1 year) follow-up of TJA patients also poses the problem that patients do not consistently see a clinician annually. Rather, they often only receive additional consultations if they have pain or other symptoms.

[0009] Currently, there is no mechanism to reliably detect misplacement, instability, or misalignment in the TJA without a clinical visit and the manual and visual observation of an experienced medical professional. Yet early identification of sub-clinical problems or conditions is either difficult or impossible because they are often too subtle to be detected on physical examination or demonstrable by x-ray studies. Furthermore, if detection were possible, corrective measures are hindered by the fact that the specific amount of displacement and / or degree of improper alignment cannot be precisely measured or quantified, making targeted and successful intervention impossible. Existing external monitoring devices do not provide the fidelity required to detect instability because these devices are separated from the TJA by skin, muscle, and fat. Each of these masks the mechanical signature of instability and introduces anomalies such as flexion, tissue-borne acoustic noise, inconsistent sensor placement on the surface, and inconsistent location of the external sensor relative to the TJA.

[0010] Furthermore, patients may experience several complications following the procedure, including neurological symptoms, pain, dysfunction (blockage, loosening, etc.), and / or implant wear, implant migration or breakage, inflammation, and / or infection. While some of these problems can be addressed with medicines and / or further surgery, they are difficult to predict and prevent, and early identification of complications and side effects, while desirable, is often difficult or impossible.

[0011] The present disclosure is directed to an intelligent implant having an implantable reporting processor that samples, records, and transmits information related to the placement and integrity of an implanted TJA and the health of a patient in whom the TJA is implanted, as well as an intelligent implant having an enhanced transmitting antenna configuration and data sampling method. Summary of the Invention

[0012] Briefly, the present disclosure relates to an intelligent implant including an implantable prosthetic component and an implantable reporting processor (IRP) associated with the component. The IRP includes a housing having a casing and a cover coupled to the casing, an electronics assembly within the housing, and an antenna within the housing and coupled to the electronics assembly. The antenna is tuned and the electronics assembly is configured to enable communication through the antenna at both 2.45 GHz and 403 MHz (MICS channels). The antenna comprises a flat ribbon configured in a loop and having a major surface. The antenna is enclosed within the cover of the housing and oriented such that its major surface is generally parallel to the inner surface of the cover to maximize the area inside the antenna loop.

[0013] The present disclosure also relates to an implantable reporting processor (IRP) configured to mechanically couple with, for example, an implantable prosthesis. The IRP includes a housing having a casing and a cover coupled to the casing, an electronics assembly within the housing, and an antenna within the housing and coupled to the electronics assembly. The antenna includes a flat ribbon configured in a loop and having a major surface oriented within the cover of the housing generally perpendicular to a plane bounded by the loop to maximize an interior area of ​​the antenna loop.

[0014] The present disclosure also relates to an implantable reporting processor (IRP) configured to be integrated with an implantable denture having a receptacle. The IRP includes a battery configured to fit within the receptacle, an electronics assembly coupled to the battery and configured within the receptacle, an antenna coupled to the electronics assembly and configured to be disposed outside the receptacle, and a cover disposed outside the receptacle and configured to enclose the antenna. The antenna includes a flat ribbon configured within a loop and having a major surface oriented within the housing cover generally perpendicular to a plane bounded by the loop to maximize an interior area of ​​the antenna loop.

[0015] The present disclosure also relates to an intelligent implant including an implantable prosthetic component and an implantable reporting processor (IRP) associated with the component. The IRP includes a plurality of sensors and a controller. The IRP is configured to perform low-resolution sampling through one or more of the plurality of sensors during a low-resolution window and to perform one of medium and high-resolution sampling through one or more of the plurality of sensors during at least one medium-resolution window. During the medium-resolution window, the IRP detects a significant motion event and performs either high-resolution sampling or medium-resolution sampling. For example, the IRP may determine whether or not high-resolution data needs to be collected. The IRP performs high-resolution sampling in response to a determination that high-resolution data needs to be collected and performs medium-resolution sampling in response to a determination that high-resolution data does not need to be collected. In another example, the IRP performs either high-resolution sampling or medium-resolution sampling depending on whether the detected significant motion event is a specific or unspecified detection. For example, the specified detection may be an initial detection of a significant motion event, and the unspecified detection may be a subsequent detection of a significant motion event after the initial detection. The IRP performs high resolution sampling in response to designated detection of significant motion events, and performs medium resolution sampling in response to designated detection of significant motion events.

[0016] The present disclosure also relates to a method of sampling data from an implantable reporting processor (IRP) of an intelligent implant implanted in a patient, the IRP being configured to sample data in each of a low resolution mode, a medium resolution mode, and a high resolution mode. The method includes performing low resolution sampling during a low resolution window and performing one of medium resolution sampling and high resolution sampling during at least one medium resolution window. Performing one of the medium resolution sampling and the high resolution sampling includes detecting a significant motion event, which may be either a designated detection or an unspecified detection. For example, the designated detection may be an initial detection of a significant motion event, and the unspecified detection may be a subsequent detection of a significant motion event after the initial detection. The method includes performing high resolution sampling in response to the designated detection of a significant motion event, and performing medium resolution sampling in response to the designated detection of a significant motion event.

[0017] The present disclosure also relates to an electronics assembly coupled to a battery of an implantable reporting processor associated with a component of an implantable prosthesis. The electronics assembly includes an inertial measurement unit (IMU) having a number of sensors, a separate accelerometer functioning independently of the IMU, and a controller coupled to the IMU and the separate accelerometer. The IMU has a number of accelerometers, a number of gyroscopes, a first measurement axis along which measurements are obtained by a first accelerometer and a first gyroscope, a second measurement axis along which measurements are obtained by a second accelerometer and a second gyroscope, and a third measurement axis along which measurements are obtained by a third accelerometer and a third gyroscope. 2. The system of claim 1, wherein the controller is configured to: during a low resolution window, couple the individual accelerometers to the battery and perform low resolution sampling through the individual accelerometers; and during a medium resolution window, a) couple the individual accelerometers to the battery and detect a significant event; b) in response to a specified detection of a significant motion event, couple the IMU to the battery and perform high resolution sampling through the multiple accelerometers and the multiple gyroscopes; and c) in response to an unspecified detection of the significant motion event, couple the IMU to the battery and perform medium resolution sampling through the multiple accelerometers and the multiple gyroscopes.

[0018] This Summary is provided to introduce certain concepts in a simplified form that are described in more detail below in the Detailed Description. Unless expressly stated otherwise, this Summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter.

[0019] Exemplary features of the present disclosure, its nature, and various advantages will be apparent from the following detailed description of the accompanying drawings and various embodiments. Non-limiting and non-exhaustive embodiments are described with reference to the accompanying drawings, in which like labels or reference numbers refer to like parts throughout the various views unless otherwise specified. The sizes and relative positions of elements in the drawings are not necessarily drawn to scale. For example, the shapes of the various elements are selected, enlarged, and positioned to improve the legibility of the drawing. The particular shapes of the depicted elements are selected for ease of recognition in the drawings. One or more embodiments are described below with reference to the accompanying drawings. [Brief description of the drawings]

[0020] [Figure 1A] FIG. 1 is a diagram of a conventional implantable medical device in the form of a knee prosthesis system or total knee arthroplasty (TKI). [Figure 1B] 1 is a diagram of a conventional implantable medical device in the form of a shoulder prosthesis system or total shoulder arthroplasty (TSI). [Figure 1C] FIG. 1 is a diagram of a conventional implantable medical device in the form of an artificial hip joint system or total hip arthroplasty (THI). [Figure 2A] FIG. 1 is a diagram of an intelligent implant in the form of a tibial component of a knee prosthesis including a tibial plate and a long-term extension implantable reporting processor extending from the tibial stem. [Figure 2B] FIG. 1 is a diagram of an intelligent implant in the form of a tibial component of a knee prosthesis including a tibial plate and a long-term extension implantable reporting processor extending from the tibial stem. [Figure 3A] FIG. 1 is a diagram of an intelligent implant in the form of a tibial component of a knee prosthesis including a tibial plate and a short extension implantable report processor extending from the tibial stem. [Figure 3B]FIG. 1 is a diagram of an intelligent implant in the form of a tibial component of a knee prosthesis including a tibial plate and a short extension implantable report processor extending from the tibial stem. [Figure 3C] FIG. 1 is a diagram of an intelligent implant in the form of a tibial component of a knee prosthesis including a tibial plate and a short extension implantable report processor extending from the tibial stem. [Figure 4A] FIG. 1 is a diagram of an intelligent implant in the form of a tibial component of a knee prosthesis including an implantable reporting processor integrated with a tibial plate and tibial stem. [Figure 4B] FIG. 1 is a diagram of an intelligent implant in the form of a tibial component of a knee prosthesis including an implantable reporting processor integrated with a tibial plate and tibial stem. [Figure 5A] FIG. 1 is a diagram of an intelligent implant in the form of a humeral component of a shoulder prosthesis including an implantable reporting processor integrated with the humeral stem. [Figure 5B] FIG. 1 is a diagram of an intelligent implant in the form of a humeral component of a shoulder prosthesis including an implantable reporting processor integrated with the humeral stem. [Figure 6A] FIG. 1 is a diagram of an intelligent implant in the form of a femoral component of a hip prosthesis including an implantable reporting processor integrated with a femoral stem. [Figure 6B] FIG. 1 is a diagram of an intelligent implant in the form of a femoral component of a hip prosthesis including an implantable reporting processor integrated with a femoral stem. [Figure 7A] FIG. 2C is a diagram of a long-term extension implantable reporting processor of the tibial component of FIGS. 2A and 2B. [Figure 7B] FIG. 2C is a diagram of a long-term extension implantable reporting processor of the tibial component of FIGS. 2A and 2B. [Figure 8A] 7B is a cross-sectional view of the implantable reporting processor of FIG. 7A. [Figure 8B]7B is a cross-sectional view of the implantable reporting processor of FIG. 7A. [Figure 8C] FIG. 7B is an exploded view of the portable reporting processor of FIG. 7A. [Figure 9] 7B is a cross-sectional perspective view of an end region of the implantable reporting processor of FIG. 7A showing the electronics assembly and antenna. [Figure 10A] FIG. 10 is a diagram of the electronic device assembly of FIGS. 8C and 9. [Figure 10B] FIG. 10 is a diagram of the electronic device assembly of FIGS. 8C and 9. [Figures 11A-11C] 7B is a series of diagrams illustrating the assembly of the portable report processor of FIG. 7A. [Figure 12A] FIG. 4 is a diagram of a short extension implantable reporting processor of the tibial component of FIGS. 3A and 3B. [Figure 12B] FIG. 4 is a diagram of a short extension implantable reporting processor of the tibial component of FIGS. 3A and 3B. [Figure 13A] 12B is a cross-sectional view of the implantable reporting processor of FIG. 12A. [Figure 13B] 12B is a cross-sectional view of the implantable reporting processor of FIG. 12A. [Figure 13C] FIG. 12B is an exploded view of the portable reporting processor of FIG. 12A. [Figure 14A] FIG. 13D is an illustration of the electronics assembly of FIG. 13C. [Figure 14B] FIG. 13D is an illustration of the electronics assembly of FIG. 13C. [Figure 15] FIG. 5C is an illustration of the intelligent implant (humeral component with integrated implantable reporting processor) of FIGS. 5A and 5B. [Figure 16A] FIG. 16 is a cross-sectional view showing the configuration of the intelligent implant of FIG. [Figure 16B] FIG. 16 is a cross-sectional view showing the configuration of the intelligent implant of FIG. [Figure 17] FIG. 16 is an exploded view of the implantable reporting processor of the intelligent implant of FIG. 15. [Figure 18A]16 is a series of diagrams illustrating the assembly of the intelligent implant of FIG. 15. [Figure 18B] 16 is a series of diagrams illustrating the assembly of the intelligent implant of FIG. 15. [Figure 18C] 16 is a series of diagrams illustrating the assembly of the intelligent implant of FIG. 15. [Figure 18D] 16 is a series of diagrams illustrating the assembly of the intelligent implant of FIG. 15. [Figure 18E] 16 is a series of diagrams illustrating the assembly of the intelligent implant of FIG. 15. [Figure 19] FIG. 6C is an illustration of the intelligent implant (femoral component with integrated implantable reporting processor) of FIGS. 6A and 6B. [Figure 20A] 20 is a detailed view of the implantable reporting processor of FIGS. 7A and 12A and the antenna of the intelligent implant of FIGS. 15 and 19. FIG. [Figure 20B] 20 is a detailed view of the implantable reporting processor of FIGS. 7A and 12A and the antenna of the intelligent implant of FIGS. 15 and 19. FIG. [Figure 20C] 20 is a detailed view of the implantable reporting processor of FIGS. 7A and 12A and the antenna of the intelligent implant of FIGS. 15 and 19. FIG. [Figure 20D] 20 is a detailed view of the implantable reporting processor of FIGS. 7A and 12A and the antenna of the intelligent implant of FIGS. 15 and 19. FIG. [Figure 20E] 20 is a detailed view of the implantable reporting processor of FIGS. 7A and 12A and the antenna of the intelligent implant of FIGS. 15 and 19. FIG. [Figure 21] FIG. 2 is a schematic block diagram of an antenna coupled to electronics of an electronic assembly. [Figure 22] FIG. 1 is a block diagram of a portable reporting processor (IRP). [Figure 23] FIG. 23 is a perspective view of an inertial measurement unit (IMU) of the implantable circuit of FIG. 22 and a set of coordinate axes in the reference frame of the IMU. [Figure 24]FIG. 2 is a diagram of a set of coordinate axes of an IMU relative to a patient implanted with a knee prosthesis. [Figure 25A] 25 is a plot versus time of linear acceleration signals ax(g), ay(g), and az(g) (in units of g-force) generated in response to acceleration along the x-, y-, and z-axes of FIG. 23 while the patient of FIG. 24 is walking forward at a normal gait at a speed of 0.9 meters / sec. [Figure 25B] 25 is a plot of angular velocity (rotational motion) signals Ωx(dps), Ωy(dps), and Ωz(dps) (in degrees / second) generated in response to angular velocities about the x-, y-, and z-axes of FIG. 23 versus time while the patient of FIG. 24 is walking at a normal gait at a speed of 0.9 meters / second. [Figure 26] FIG. 2 is a diagram of a set of IMU coordinate axes relative to a patient in which a shoulder prosthesis is implanted. [Figure 27A] 27 is a plot of angular velocity (rotation-motion) signals generated in response to angular velocity about one of the x-axis, y-axis, and z-axis of FIG. 23 while the patient of FIG. 26 is performing a movement. [Figure 27B] 27 is a plot of angular velocity (rotation-motion) signals generated in response to angular velocity about one of the x-axis, y-axis, and z-axis of FIG. 23 while the patient of FIG. 26 is performing a movement. [Figure 27C] 27 is a plot of angular velocity (rotation-motion) signals generated in response to angular velocity about one of the x-axis, y-axis, and z-axis of FIG. 23 while the patient of FIG. 26 is performing a movement; [Figure 28] FIG. 2 is a diagram of a set of IMU coordinate axes relative to a patient in which a hip prosthesis will be implanted. [Figure 29] 23 is a flow chart of a method of data sampling implemented by the implantable reporting processor of FIG. 22. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0021] The present disclosure may be more readily understood by reference to the following detailed description of embodiments of the present disclosure and examples of implantable medical devices having an implantable report processor. The following description, together with the accompanying drawings, sets forth certain specific details to provide a thorough understanding of various disclosed embodiments. However, those skilled in the art will recognize that the disclosed embodiments may be practiced in various combinations without one or more of these specific details, or with other methods, components, devices, materials, etc. In other instances, well-known structures or components relevant to the environment of the present disclosure, including but not limited to communication systems and networks, are not shown or described to avoid unnecessarily obscuring the description of the embodiments.

[0022] The present disclosure refers to orthopedic implant procedures, such as TJA (total joint arthroplasty), which term includes reference to surgery and associated implantable medical devices, such as TJA prostheses. Features of the methods, apparatus and systems of the present disclosure may be illustrated herein with reference to specific types of prostheses. However, the present disclosure should be understood to apply to any one or more orthopedic prostheses, such as TKA (total knee arthroplasty) prostheses, such as TKI (total knee arthroplasty), which may also be referred to as TKA systems, TSA (total shoulder arthroplasty) prostheses, such as TSI (total shoulder implant), which may also be referred to as TSI systems, and THA (total hip arthroplasty) prostheses, such as THI (total hip implant), which may also be referred to as THA systems, spinal implant systems (e.g., spinal fusion implants, such as spinal interbody cages, and rods or plates, or spinal non-fusion implants, such as artificial discs or expandable rods).

[0023] As used in this disclosure, an "implantable medical device" is an implantable or implanted medical device that preferably replaces or functionally complements a natural body part of a subject. As used herein, the term "intelligent implant" refers to an implantable medical device having an implantable reporting processor, and is interchangeably referred to as a "smart device." When an intelligent implant performs kinematic measurements, it may be referred to as a kinematic implantable device. In describing embodiments of the present disclosure, reference may be made to a kinematic implantable device, but it should be understood that this is merely an example of an intelligent medical device that may be used in the devices, methods, systems, etc. of the present disclosure.

[0024] In one embodiment, an intelligent implant is an implanted or implantable medical device having an implantable reporting processor arranged to perform the functions described herein. An intelligent implant may perform one or more of the following exemplary operations to characterize a post-implantation status of an intelligent implant: A method comprising: identifying the intelligent implant or a portion of the intelligent implant, detecting, for example, by recognizing one or more unique identification codes for the intelligent implant or a portion of the intelligent implant; sensing and / or measuring parameters, which may be collectively referred to as monitoring parameters, such as kinematics or other data related to the intelligent implant or a portion of the intelligent implant for business purposes, which data may be collected over time, storing the collected data within the intelligent implant or a portion of the intelligent implant; and communicating the collected and / or stored data from the intelligent implant or a portion of the intelligent implant by wireless means to an external computing device. The external computing device may have access to at least one data storage location, such as a personal computer, a base station, a computer network, a cloud-based storage system, or another computing device having access to such storage, or may otherwise have access to such storage.

[0025] A non-limiting and non-exhaustive list of embodiments of intelligent implants include components of total knee arthroplasty (TKA) systems, total hip arthroplasty (THA) systems, total shoulder arthroplasty (TSA) systems, intramedullary rods for arm or leg fracture repair, scoliosis rods, dynamic hip screws, spinal interbody cages, spinal rods, spinal plates, spinal mid-spacers, spinal disc prostheses, annuloplasty rings, heart valves, endovascular stents, vascular grafts, and vascular stent grafts.

[0026] As used herein, kinematic data, individually or collectively, includes some or all of the data associated with a particular kinematic implantable device and available for communication outside of a particular kinematic implantable device. For example, kinematic data may include raw data from one or more sensors of a kinematic implantable device, including gyroscopes, accelerometers, pedometers, strain gauges, etc., that generate data associated with motion, force, tension, velocity, or other mechanical forces. Kinematic data may also include processed data, status data, operational data, control data, fault data, time data, scheduled data, event data, log data, etc., from one or more sensors associated with a particular kinematic implantable device. In some cases, high-resolution kinematic data includes kinematic data from one, many, or all of the sensors of a kinematic implantable device, collected in greater volume, resolution, from more sensors, more frequently, or the like.

[0027] In one embodiment, kinematics refers to the measurement of positions, angles, velocities, and accelerations of body segments and joints during motion. Body segments are considered to be rigid bodies for the purposes of describing body motion. They include the foot, shank (leg), thigh, pelvis, chest, hand, forearm, upper arm, and head. Joints between adjacent segments include the ankle (plexus + subthalamic joint), knee, hip, wrist, elbow, shoulder, and spine (or parts thereof). Position describes the position of a body segment or joint in space, measured in terms of distance, for example in meters. A related measurement called displacement refers to the position relative to a starting position. In two dimensions, position is given in Cartesian coordinates, horizontal followed by vertical position. In one embodiment, a kinematic implant or intelligent kinematic implant acquires kinematic data, and optionally only kinematic data.

[0028] A sensor refers to a device that can be utilized to detect, measure, and / or monitor one or more different aspects of a body tissue (anatomy, physiology, metabolism, and / or function) and / or one or more aspects of an orthopedic device or implant. Representative examples of sensors suitable for use within the present disclosure include, for example, fluid pressure sensors, fluid volume sensors, contact sensors, position sensors, pulse pressure sensors, blood volume sensors, blood flow sensors, chemical sensors (e.g., for blood and / or other fluids), metabolic sensors (e.g., for blood and / or other fluids), accelerometers, mechanical stress sensors, and temperature sensors. In certain embodiments, the sensors may be wireless sensors, or in other embodiments, sensors connected to a wireless microprocessor. In further embodiments, one or more (including all) of the sensors may have a unique sensor identification number (USI) that uniquely identifies the sensor. In certain embodiments, the sensor is a device that can be utilized to measure one or more different aspects of a body tissue (anatomy, physiology, metabolism, and / or function) and / or one or more aspects of an orthopedic device or implant in a quantitative manner. In certain embodiments, the sensor is an accelerometer that can be utilized to measure a quantitative manner, one or more different aspects of a body tissue (e.g., function), and / or one or more aspects of an orthopedic device or implant (e.g., alignment in a patient).

[0029] A wide variety of sensors (Microelectromechanical systems or MEMS, also referred to as Nanoelectromechanical systems or NEMS, and BioMEMS or BioNEMS, generally https: / / en.wikipedia.org / wiki / MEMS) may be utilized in the present disclosure. Representative patents and patent applications include U.S. Patent Nos. 7,383,071, 7,450,332, 7,463,997, 7,924,267, and 8,634,928, and U.S. Publication Nos. 2010 / 0285082 and 2013 / 0215979.Representative publications include “Introduction to BioMEMS” by Albert Foch, CRC Press, 2013; “From MEMS to Bio-MEMS and Bio-NEMS: Manufacturing Techniques and Applications by Marc J. Madou, CRC Press 2011; “Bio-MEMS: Science and Engineering Perspectives, by Simona Badilescu, CRC Press 2011; “Fundamentals of BioMEMS and Medical Microdevices” by Steven S. Saliterman, SPIE-The International Society of Optical Engineering, 2006; “Bio-MEMS: Technologies and Applications” by Wanjun Wang and Steven A. Soper, CRC Press, 2012; and “Inertial MEMS: Principles and Practice” by Volker Kempe, Cambridge University Press, 2011; Polla, DL, et al., “Microdevices in Medicine,” Ann. Rev. Biomed. Engagement. See Yoon, KSet al., “A Surface-Tension Driven Micropump for Low-voltage and Low-Power Operations,” 2000, 02:551-576.J. Microelectromechanical Syst., 11:5, October 2002, 454-461; Yeh, R., et al., “Single-Mask, High Force and Large Displacement Electrostatic Linear Inscorm Motors,” J. Microelectromechanical Syst., 11:4, August 2002, 330-336; and N. C., et al., “Sub-10 cm3 Interferometric Accelerometer with Nano-g Resolution,” J. Microelectromechanical Syst., 11:3, June 2002, 182-187, all of the above are incorporated by reference in their entireties.

[0030] Intelligent Implants The present disclosure provides an intelligent implant, e.g., an implantable medical device having an implantable reporting processor (IRP). When the intelligent implant is included in a component of an implant system that replaces a joint, the intelligent implant can monitor the displacement or movement of the component or implant system. The intelligent implant can also provide motion data that can be used to assess the mobility and health of a patient in whom the system is implanted.

[0031] In Figures 2A, 2B, 3A, 3B, 3C, 4A, and 4B, the intelligent implant 100, 300, 400 may be part of a knee joint implant system. In these embodiments, the intelligent implant 100, 300, 400 corresponds to a tibial component of a knee replacement system for TKA and includes a tibial plate 106, 306, 406 and an implantable reporting processor (IRP) 104, 304, 404. The tibial plate 106, 306, 406 is configured to physically attach to a superior surface of the tibia 108. A tibial stem 110, 310, 410 or tibial keel extends from the tibial plate 106, 306, 406. The tibial stem 110 , 310 , 410 includes a receptacle 112 , 312 , 412 configured to receive a portion of the implantable reporting processor 104 , 304 , 404 .

[0032] As shown in Figures 2A and 2B, the tibial plate 106 is bonded or adhered to the upper surface of the tibia using a biocompatible cement to establish a physical attachment between the tibial component 100 and the tibia. As shown in Figures 3A, 3B, 3C, 4A and 4B, a portion of the tibial plate 306, 406 is configured to adhere to the upper surface of the tibia in the absence of cement. To this end, the portion of the tibial plate 306, 406 may be an underside that faces the tibia and may include a layer of porous ingrowth material into which bone tissue may grow to secure the tibial plate in place. The porous layer may be formed, for example, by cobalt chromium sintered beads, titanium fiber metal mesh, cancellous titanium, and titanium plasma spray. Several protrusions 305, 405 or pegs may extend from the underside. These protrusions 305, 405 are configured to be pressed into the upper surface of the tibia to establish an initial fixation or physical attachment between the tibial component 300, 400 and the tibia. 3A, 3B, 4A and 4B are referred to as cementless tibial components. Patient selection for cementless tibial components tends to be younger patients with healthier bone (not osteoporotic). The basic concept of cementless tibial component design is to provide wings for rotational stability, but the tibial stem of these components tends to be narrow to minimize the amount of bone removed. Minimal bone removal is one of the preferred aspects of cementless. More of the resected tibial bone needs to be removed to form a cement mantel around the implant.

[0033] As shown in Figures 2A, 2B, 3A, 3B, and 3C, the implantable reporting processor 104, 304 is a component assembly that is manufactured separately from the tibial plate 106, 306 and mechanically coupled to the tibial stem 110, 310 of the tibial plate to form the tibial component 100, 300. To this end, a portion of the implantable reporting processor 104, 304 is inserted into a receptacle 112, 312 of the tibial stem 110, 310 and fixed in place therein by applying a force that couples the respective mechanical features of the implantable reporting processor and the tibial plate 106, 306. As shown in Figures 4A and 4B, the implantable reporting processor 404 is assembled to the tibial stem 410 of the tibial plate 406 during assembly. For this purpose, a subassembly 409 of the implantable reporting processor 104 is inserted into a receptacle 412 of the tibial stem 410, and a cover 411 of the implantable reporting processor is coupled to the subassembly 409 and to the tibial stem. The subassembly 409 includes a battery 413, an electronics assembly 415, an antenna feedthrough 417, and an antenna 419.

[0034] In another embodiment, the intelligent implant corresponds to a femoral component of a knee implant system. The femoral component is shown in FIG. 1A. The femoral component may be a unicondylar femoral component (not shown) used in partial knee arthroplasty (PKA). In either case, the implantable reporting processor may be configured to physically attach to an extension of the femoral component.

[0035] 5A and 5B, the intelligent implant 120 may be part of a shoulder implant system 122. In this embodiment, the intelligent implant 120 corresponds to a humeral component of a shoulder replacement system for TSA and includes an implantable reporting processor (IRP) 124. The humeral component 120 includes a humeral stem 126, a humeral body 128, and a humeral head adaptor 130. The humeral head adaptor 130 is configured to physically attach to a glenoid cap 132. The humeral stem 126 includes a receptacle 134 configured to receive the implantable reporting processor 124.

[0036] 6A and 6B, the intelligent implant 140 may be part of a hip implant system 142. In this embodiment, the intelligent implant 140 corresponds to a femoral component of a hip replacement system for THA and includes an implantable reporting processor (IRP) 144. The femoral component 140 includes a femoral stem 146, a femoral body 148, and a femoral neck 150. The femoral neck 150 is configured to physically attach to a femoral head 152 that is configured to attach to an acetabular cap 154. The femoral body 148 includes a receptacle 156 configured to receive the implantable reporting processor 144.

[0037] Portable Report Processor The present disclosure provides an implantable reporting processor (IRP) for a joint replacement implant system. Disclosed embodiments include an IRP for a knee implant system, an IRP for a shoulder implant system, and an IRP for a hip implant system. As previously mentioned, in some embodiments, the IRP is a component assembly that is manufactured independently of other components of the implant system and then assembled with the components of the implant system. In some embodiments, the IRP is integrated with the components of the implant system during the manufacture of the components.

[0038] Component Assembly Portable Report Processor 7A and 7B, an implantable reporting processor 104 for an intelligent implant 100 corresponding to a tibial component as shown in FIG. 2A is configured to function as a long tibial stem extension. An implantable reporting processor 104 for an intelligent implant 100 corresponding to a tibial component as shown in FIG. 7A and 7B. FIG. 2A is configured to function as a long tibial stem extension. This long-term extension implantable reporting processor 104 includes a housing that encloses a battery 204, an electronic assembly 206, and an antenna 208. The housing 202 of the implantable reporting processor 104 includes a cover 210 or radome, and a casing 216 or extension. The casing 216 includes a central section 212, an upper connecting section 214, and a lower connecting section 218 to which the cover 210 is configured to connect.

[0039] The housing 202 has a length L1 of about 73 millimeters (mm) and a diameter D1 of about 14 mm at its widest cross section. In various embodiments, the implantable reporting processor 104 may have a length L1 in the range of 70 mm to 100 mm. In various embodiments, the implantable reporting processor 104 may have a diameter D1 at its widest cross section in the range of 5 mm to 30 mm. It is noted that the term diameter is used in a broad sense to refer to the maximum cross-sectional distance, and that the cross section need not be an exact circle, but may be other shapes such as elliptical, oval, or even four, five, or six sides.

[0040] The cover 210 covers and protects the antenna 208, which allows the implantable reporting processor 104 to receive and transmit data / information (hereinafter, information). The cover 210 can be made of any material, such as plastic or ceramic, that allows radio frequency (RF) signals to propagate through the cover with acceptable levels of attenuation and other signal degradation. In some embodiments, the cover 210 is made of polyetheretherketone (PEEK).

[0041] The central section 212 and the upper linking section 214 are integral with one another, cover and protect the electronic assembly 206 and the battery 204, and may be made of any suitable material, such as metal, plastic, or ceramic. Additionally, the central section 212 includes an alignment mark 220 that is configured to align with a corresponding alignment mark on the outside of the receptacle 112 of the tibial component shown in Figures 1A and 1B. When the tibial component of the knee implant is implanted, aligning the alignment mark 220 with the mark on the receptacle 112 ensures that the implantable reporting processor 104 is in a desired orientation relative to the tibial stem 110.

[0042] The upper connection section 214 is sized and otherwise configured to fit into the receptacle 112 of the tibial stem 110. The fit may be snug enough so as not to require a fixation mechanism (e.g., adhesive, set screw), or the upper connection section 214 may include a fixation mechanism, such as threads, clips, and / or set screws (not shown) and set screw engagement holes, for attaching and securing the implantable reporting processor 104 to the tibial stem 110.

[0043] 8A, 8B, 8C, and 9, the major components of the implantable reporting processor 104 include a battery 204, an electronic assembly 206, and an antenna 208. The battery 204 is configured to power the electronic circuitry of the implantable reporting processor 104 for a significant portion (e.g., 1-15 years or more, e.g., 10 years or more, or 15 years or more) or for the entirety (e.g., 18 years or more) of the expected life of the implantable reporting processor.

[0044] In some embodiments, the battery 204 has a lithium-carbon-monofluoride (LiCFx) chemistry, a cylindrical housing or cylindrical container 506, a cathode terminal 502, and an anode terminal 504, which is a plate surrounding the cathode terminal. LiCFx is a non-rechargeable (primary) chemistry, which is advantageous for maximizing the battery energy storage capacity. The cathode terminal 502 makes conductive contact with the internal cathode electrode and is bonded to the cylindrical container using a glass or ceramic hermetic feed-through insulating material. The use of an airtight feed prevents leakage of internal battery materials or reactive products to the external battery surface. Additionally, the glass or ceramic feed-through material electrically insulates the cathode terminal 502 from the cylindrical container 506, which makes conductive contact with the internal anode electrode. The anode terminal 504 is welded to the cylindrical container 506. By locating the negative terminal 502 and the positive terminal 504 on the same end of the battery 204, both terminals can be coupled to the electronic assembly 206 without having to run leads or other conductors to opposite ends of the battery.

[0045] The container 506 may be formed from any suitable material, such as titanium or stainless steel, and may have any suitable configuration to limit the expansion of the battery 204 as the battery heats up during use. Because the battery 204 is inside the casing 216, if the battery expands too much it could crack the container 506 or casing 216, or irritate the subject's tibia or other body tissue.

[0046] With LiCFx chemistry, the battery 204 can provide approximately 360 milliamp hours (mAh) at 3.7 volts (V) over its life, but can increase this output by approximately 36 mAh for every 5 mm of length added to the battery (similarly, can decrease this output by approximately 36 mAh for every 5 mm of length subtracted from the battery). Of course, other battery chemistries can be used if they can achieve the appropriate power requirements for a given application, subject to the application's size and life requirements. Some additional potential battery chemistries include, but are not limited to, lithium ion (Li-ion), lithium manganese dioxide (Li-MnO2), silver vanadium oxide (SVO), lithium chloride (Li-SOCl2), lithium iodide, and hybrid types made up of combinations of the above chemistries, such as CFx-SVO.

[0047] The electronics assembly 206 includes a circuit assembly 207 having one or more sensors and a processor configured to receive and process information from the sensors related to the status and functionality of the implantable reporting processor 104 and the status of the patient in which the implantable reporting processor is implanted. The electronics assembly 206 is further configured to transmit the processed information to an external device via an antenna 208.

[0048] 10A and 10B, the assembly 207 includes a first printed circuit board (PCB) 802 and a second PCB 804, each having various electronic components mounted thereon. The two PCBs 802, 804 are connected to each other by a flex wire 806. The circuit assembly 207 also includes an antenna terminal board 808 connected to the first PCB 802 by a flex wire 810 and a battery terminal board 812 connected to the second PCB 804 by a flex wire 814. The flex wires 806, 810, 814 allow the circuit assembly 207 to be folded to form an open box structure, as shown in FIGS. 8C and 9, such that the two PCBs 802, 804 are generally parallel to each other and the two terminal boards 808, 812 are generally parallel to each other.

[0049] The circuit assembly 207 is physically and electrically coupled to the antenna 208 through terminals on an antenna terminal board 808 and to a power component (e.g., a battery) through terminals on a battery terminal board 812. The PCBs 802, 804 may include an inertial measurement unit (IMU) integrated circuit, a real-time clock (RTC) integrated circuit, a memory integrated circuit (Flash), and other circuit components on one side, and a microcontroller (MCU) integrated circuit, a radio transmitter (Radio) integrated circuit, and other circuit components on the other side. In either case, the folded circuit assembly 207 provides a compact configuration that saves a significant amount of physical space within the implantable reporting processor.

[0050] As shown in FIG. 8C, other components of the assembly 206 include a liner 602, an upper shroud 604, a lower shroud 606, an X-ray ID 608, a flange 610, an implant grade bipolar feedthrough 612, and an antenna spacer 616. The liner 602 functions to mechanically stabilize the circuit assembly 207 within the housing of the implantable reporting processor 104 and includes three components 603a, 603b, 603c formed from any suitable material including, for example, polycarbonate. The upper shroud 604 and the lower shroud 606 are formed from a biocompatible metallic material. In some embodiments, the material is titanium. The flange 610 is formed from a biocompatible metallic material. In some embodiments, the material is titanium. The antenna spacer 616 is formed from a non-conductive biocompatible material. In some embodiments, the antenna spacer 616 is formed from PEEK. The feedthrough 612 is formed from a non-conductive biocompatible material. In some embodiments, the feedthrough 612 is formed of ceramic. X-ray ID 608 for the purpose of providing identification of the implantable reporting processor 104 independent of wireless communication.

[0051] As shown in Figures 11A-11C, the implantable report processor 104 of Figure 1. 8C is assembled from the pre-assembled hermetic assembly 136, the antenna 208, and the cover 210. With reference to Figures 11B and 11C, the antenna spacer 616 is placed over the external pin of the feedthrough 612 (shown in Figure 8C) of the hermetic assembly 136, and the antenna 208 is welded to the feedthrough pin. The cover 210 is then assembled onto the lower connection section 218 of the casing 216. In some embodiments, the cover is backfilled with epoxy (fill and bleed ports are not shown). The epoxy material encapsulates the antenna 208 within the cover 210. The epoxy material may be medical grade silicone. Encapsulating the antenna 208 increases the structural rigidity of the implantable report processor 104 and isolates the antenna from tissue and body fluids.

[0052] Thus, an implantable reporting processor 104 is disclosed in which all active electronics and the battery 204 are housed within the sealed assembly 136. The ground reference potential of the battery 204 is physically welded to the lower shroud 606 and the casing 216. Due to the intimate contact with the surrounding tissue between the casing 216 and the tibial plate 106, the ground reference potential of the implantable reporting processor 104 is equal to the body tissue potential (electrically neutral with the surrounding tissue). Within the sealed assembly 136, both the battery 204 reference potential (GND) and the battery positive terminal potential (VBATT) are routed throughout the electronic assembly 206 to power the electronic components. A feedthrough 612 provides a connection between the electronics inside the sealed assembly 136 and the loop antenna 208 outside the sealed assembly. The antenna 208 is a conductive loop formed of platinum-iridium (PtIr=90 / 10) ribbon with one end connected to the wireless transceiver and the other end connected to the battery reference potential (GND). The loop antenna 208 provides a magnetic loop; for example, an AC signal in a conductive loop generates a magnetic field. The antenna 208 is encapsulated by a cover 210 and an epoxy backfill, both of which are non-conductive. The antenna 208 is the only electrically active component of the implantable reporting processor 104 outside of the sealing assembly 136, and under normal operating conditions, the epoxy fill and PEEK cover insulate it from electrically interacting with the surrounding tissue.

[0053] 12A and 12B, an implantable reporting processor 304 for an intelligent implant 300 corresponding to a tibial component as shown in FIG. 3A is configured to function as a short tibial stem extension. The short extension implantable reporting processor 304 includes a housing that encloses a battery 314, an electronics assembly 316, and an antenna 318. The housing 302 of the implantable reporting processor 304 includes a cover 320 or radome and a casing 322. The casing 322 includes a central section 324, an upper link section 326, and a lower link section 328 to which the cover 320 is configured to link.

[0054] The housing 302 has a length L1 of about 28 millimeters (mm) and a diameter D1 at its widest cross section of about 14 mm. In various embodiments, the implantable reporting processor 104 may have a length L1 in the range of 20 mm to 30 mm. In various embodiments, the implantable reporting processor 304 may have a diameter D1 at its widest cross section in the range of 5 mm to 30 mm. It is noted that the term diameter is used in a broad sense to refer to the maximum cross section distance, and that the cross section need not be an exact circle, but may be other shapes such as elliptical, oval, or even four, five, or six sides.

[0055] The cover 320 covers and protects the antenna 318, which allows the implantable reporting processor 304 to receive and transmit data / information (hereinafter, information). The cover 320 can be made of any material, such as plastic or ceramic, that allows radio frequency (RF) signals to propagate through the cover with acceptable levels of attenuation and other signal degradation. In some embodiments, the cover 210 is made of polyetheretherketone (PEEK).

[0056] The central section 324 and the upper linking section 326 are integral with one another, cover and protect the electronic assembly 316 and the battery 314, and may be made of any suitable material, such as metal, plastic, or ceramic. Additionally, the central section 324 includes an alignment mark 330 that is configured to align with a corresponding alignment mark on the outside of the receptacle 312 of the tibial component shown in Figures 3A and 3B. When the tibial component of the knee implant is implanted, aligning the alignment mark 330 with the mark on the receptacle 312 ensures that the implantable reporting processor 304 is in a desired orientation relative to the tibial stem 310.

[0057] The upper connection section 326 is sized and otherwise configured to fit into the receptacle 312 of the tibial stem 310. The fit may be sufficiently slippery so as not to require a fixation mechanism (e.g., adhesive, set screw), or the upper connection section 326 may include a fixation mechanism, such as threads, clips, and / or a set screw (not shown) and set screw engagement hole, for attaching and securing the implantable reporting processor 304 to the tibial stem 310.

[0058] As shown in Figures 13A, 13B, and 13C, the main components of the implantable reporting processor 304 include a battery 314, an electronic assembly 316, and an antenna 318. The battery 314 is configured to power the electronic circuitry of the implantable reporting processor 304 for a majority (e.g., 1-15 years or more, e.g., 10 years or more, or 15 years or more) or for the entirety (e.g., 18 years or more) of the expected life of the implantable reporting processor. The battery 314 can be configured similarly to that shown in Figures 8A, 8B, and 8C and described above. Accordingly, details of the battery configuration are omitted.

[0059] The electronics assembly 316 includes a circuit assembly 317 having one or more sensors and a processor configured to receive and process information from the sensors related to the status and functionality of the implantable reporting processor 304 and the status of the patient in which the implantable reporting processor is implanted. The electronics assembly 316 is further configured to transmit the processed information to an external device via an antenna 318.

[0060] As shown in Figures 14A and 14B, the assembly 317 is a rigid flex printed circuit board (PCB) assembly and includes a first PCB 822 and a second PCB 824. The first PCB 822 and the second PCB 824 are rigid PCBs with various electronic components mounted thereon. The two rigid PCBs 822, 824 are connected by a flex section 826. The circuit assembly 317 also includes an antenna terminal board 828 connected to the first PCB 822 by a flex section 830 and a battery terminal board 832 connected to the second PCB 824 by a flex section 834. The flex sections 826, 830, 834, which may be polyamide sections, allow the circuit assembly 317 to be folded so that the two PCBs 822, 824 are generally parallel to each other and the two terminal boards 828, 832 are generally parallel to each other to form an open box structure, as shown in Figure 13C.

[0061] The circuit assembly 317 is physically and electrically coupled to the antenna 318 through terminals on an antenna terminal board 828 and to power components (e.g., a battery) through terminals on a battery terminal board 832. The PCBs 822, 824 may include an inertial measurement unit (IMU) integrated circuit, an accelerometer (ACC), a microcontroller (MCU) integrated circuit, and other circuit components on one side, and a real-time clock (RTC) integrated circuit, a memory integrated circuit (FRAM®), a wireless transmitter (MICS) integrated circuit, and other circuit components on the other side. In either case, the folded circuit assembly 317 provides a compact configuration that saves a significant amount of physical space within the implantable reporting processor.

[0062] As shown in FIG. 13C, other components of the assembly 316 include a first liner 702, a second liner 704, a sleeve 706, an X-ray ID 708, a flange 710, an implant grade bipolar feedthrough 712, and an antenna spacer 716. The first liner 702 and the second liner 704 function to mechanically stabilize the circuit assembly 317 and its associated sensors, such as accelerometers and gyroscopes, within the sleeve 706 and within the casing 322 of the implantable reporting processor 304. The first liner 702 and the second liner 704 also function to isolate the circuit assembly 317 from external forces (e.g., shock or vibration). The stabilization and shock absorption functions of the circuit assembly 317 and its sensors function to minimize mechanical movement or shift of the sensors within the implantable reporting processor 304 and maintain the orientation of the sensors within an acceptable degree of offset with respect to the axis the sensors are aligned to and around or along the axis the sensors measure. During manufacture of the implantable reporting processor 304, the sensor is aligned with an axis (e.g., a black line marker on the casing 322) and any residual readings made by the sensor (e.g., non-zero readings when a zero reading is expected) are accounted for through calibration. The liners 702, 704 keep the sensor relatively stable within a tolerance to the alignment axis. For the gyroscope, the liners 702, 704 are configured to maintain a residual offset of less than 10 degrees or 3 degrees per second before calibration and less than 0.1 degrees or 0.5 degrees per second after calibration. For the accelerometer, the liners 702, 704 are configured to maintain a residual offset of less than 0.1 g or 0.15 g before calibration and less than 0.02 g or 0.01 g after calibration. Note that the preceding degrees per second and g values ​​are electrical parameters output by the gyroscope and accelerometer, respectively, that are translated from the mechanical misalignment of the sensors that the liners 702, 704 function to minimize.

[0063] The first liner 702 and the second liner 704 may be formed from any suitable material including, for example, polycarbonate. The sleeve 706 may be formed from a biocompatible metallic material. In some embodiments, the material is titanium. The flange 710 is formed from a biocompatible metallic material. In some embodiments, the material is titanium. The antenna spacer 716 is formed from a non-conductive biocompatible material. In some embodiments, the antenna spacer 716 is formed from PEEK. The feedthrough 712 is formed from a non-conductive biocompatible material. In some embodiments, the feedthrough 712 is formed from a ceramic. X-ray ID 708 for purposes of providing identification of the implantable reporting processor 304 independent of wireless communication.

[0064] The implantable report processor 304 of FIG. 13C can be constructed in the same manner as disclosed above with reference to FIGS. 11A-11C.

[0065] Built-in embedded report processor 15, 16A and 16B, an implantable reporting processor 124 is integrated into the humeral component 120 of a shoulder implant system as shown in FIG. 5A. The implantable reporting processor 124 may have a length ranging from 91 mm to 94 mm for a standard size humeral component (FIG. 16A) and a length ranging from 66 mm to 69 mm for a micro size humeral component (FIG. 16B). In either configuration, the implantable reporting processor 124 includes a battery 740 configured to fit within a receptacle 742 formed within a humeral stem 744 portion of the humeral component 120, an electronics assembly 746 configured to fit within the receptacle, an antenna 748 outside the receptacle extending from a tip 750 of the humeral stem, and a cover 752 covering the antenna. An antenna feedthrough 754 at the tip 750 of the humeral stem 744 extends partially into the receptacle 742.

[0066] As shown in Figures 16A, 16B, and 17, the primary components of the implantable reporting processor 124 include a battery 740, an electronic assembly 746, and an antenna 748. The battery 740 is configured to power the electronic circuitry of the implantable reporting processor 124 for a majority (e.g., 1-15 years or more, e.g., 10 years or more, or 15 years or more) or for the entirety (e.g., 18 years or more) of the expected life of the implantable reporting processor. The battery 740 can be configured similarly to that shown in Figures 8A, 8B, and 8C and described above. Accordingly, details of the battery configuration are omitted here.

[0067] The electronic assembly 746 includes a circuit assembly 747 having one or more sensors and a processor configured to receive and process information from the sensors related to the status and functionality of the implantable reporting processor 124 and the status of the patient in which the implantable reporting processor is implanted. The electronic assembly 746 is further configured to transmit the processed information to an external device through an antenna 748. The circuit assembly 747 of the electronic assembly 746 may be configured as described above with reference to Figures 14A and 14B. Accordingly, details of the electronic assembly 746 are omitted here. The antenna 748 may be configured as described below in the antenna design section of this disclosure.

[0068] 17, other components of the implantable report processor 124 include a first liner 762, a second liner 764, a sleeve 766, a flange 768, and an implant grade bipolar feedthrough 770. The first liner 762, the second liner 764 function to mechanically stabilize the electronic assembly 746 within the sleeve 766. The first liner 762 and the second liner 764 may be formed of any suitable material including, for example, polycarbonate. The sleeve 766 may be formed of a biocompatible metallic material. In some embodiments, the material is titanium. The flange 768 is formed of a biocompatible metallic material. In some embodiments, the material is titanium. The antenna spacer 716 is formed of a non-conductive biocompatible material. In some embodiments, the antenna spacer 716 is formed of PEEK. The feedthrough 770 is formed of a non-conductive biocompatible material. In some embodiments, the feedthrough 770 is formed of a ceramic.

[0069] As shown in Figures 18A, 18B, 18C, 18D, and 18E, an intelligent implant for a shoulder implant system is assembled from a humeral component 120, a sealing subassembly 756, an antenna 748, and a cover 752. Referring to Figures 18B and 18C, the hermetic subassembly 756 is placed in a receptacle 742 of the humeral component 1820, and the distal end of the hermetic subassembly is hermetically welded to the distal end of the humeral component. As shown in Figure 18D, an antenna spacer 758 is placed over an external pin of a feedthrough 754 (shown in Figure 18C) of the hermetic subassembly 756, and an antenna 748 is welded to the feedthrough pin. The antenna spacer 716 is formed of a non-conductive biocompatible material. In some embodiments, the antenna spacer 716 is formed of PEEK. As shown in Figure 18E, the cover 752 is assembled and secured onto the tip 750 of the humeral component 120. In some embodiments, the cover 752 is backfilled with epoxy (fill and bleed ports not shown). The epoxy material encapsulates the antenna 748 within the cover 752. The epoxy material may be a medical grade silicone. Encapsulating the antenna 748 increases the structural rigidity of the portion of the implantable reporting processor 124 that extends from the receptacle 742 of the humeral component 120 and isolates the antenna from tissue and bodily fluids.

[0070] As shown in Fig. 19, the reporting processor 144 is integrated with the femoral component 140 of the hip implant system as shown in Fig. 6A. The implantable reporting processor 144 includes a battery 780 configured to fit within a receptacle 782 formed in the proximal midline portion 151 of the femoral component 140, an electronic assembly 784 configured to fit within the receptacle, an antenna 786 outside the receptacle extending from a surface of the femoral component, and a cover 788 covering the antenna. An antenna feedthrough 790 of the electronic assembly 784 is positioned on a surface of the femoral component 140 and extends partially into the receptacle 782. The electronic assembly 784 is hermetically welded to the femoral component 140, thereby creating an airtight chamber within the receptacle 782.

[0071] The battery 780 is configured to power the electronic circuitry of the implantable reporting processor 144 for a significant portion (e.g., 1-15 years or more, e.g., 10 years or more, or 15 years or more) or for the entirety (e.g., 18 years or more) of the expected life of the implantable reporting processor. The battery 780 may be configured similarly as described above with reference to Figures 8A, 8B, and 8C. Accordingly, details of the battery configuration are omitted here.

[0072] The electronic assembly 784 includes a circuit assembly 785 including one or more sensors and a processor configured to receive and process information from the sensors related to the status and function of the implantable reporting processor 144 and the status of the patient in which the implantable reporting processor is implanted. The electronic assembly 784 is further configured to transmit the processed information to an external device through an antenna 786. The circuit assembly 785 of the electronic assembly 784 may be configured as shown in Figures 14A and 14B and described above. Accordingly, details of the electronic assembly 784 are omitted here. The antenna 786 may be configured as described below in the antenna design section of this disclosure.

[0073] In some embodiments, during assembly, the cover 788 is backfilled with epoxy (fill and bleed ports not shown). The epoxy material encapsulates the antenna 786 within the cover 788. The epoxy material may be a medical grade silicone. Encapsulating the antenna 786 increases the structural rigidity of the portion of the implantable reporting processor 144 that extends from the receptacle 782 of the femoral component 140 and isolates the antenna from tissue and bodily fluids.

[0074] As shown in Figures 4A and 4B, the implantable reporting processor 404 is integrated with a tibial component 400 of a knee implant system. The implantable reporting processor 404 includes a subassembly 409 configured to fit within a receptacle 412 formed within a tibial stem 410 portion of the tibial component. The subassembly 409 includes a battery 413, an electronics assembly 415, an antenna feedthrough 417, and an antenna 419. When the subassembly 409 is disposed within the receptacle 412, the battery 413 and the electronics assembly 415 are located inside the receptacle 412 and the antenna 419 is located outside the receptacle. The antenna feedthrough 417 extends partially into the receptacle 412. The electronic assembly 415 portion of the subassembly 409 is hermetically welded to the tibial stem 410, thereby creating an airtight chamber in the receptacle 412 in which the battery 413 and electronic assembly 415 reside. A cover 411 covers the antenna 419 and may be secured to the tibial stem 410 by a threaded connection. Alternatively, the cover 411 may be overmolded onto the subassembly 409 prior to placing the subassembly in the receptacle 412.

[0075] The battery 413 is configured to power the electronic circuitry of the implantable reporting processor 404 for a majority (e.g., 1-15 years or more, e.g., 10 years or more, or 15 years or more) or for the entirety (e.g., 18 years or more) of the expected life of the implantable reporting processor. The battery 413 may be configured similarly to those shown in Figures 8A, 8B, and 8C and described above. Accordingly, details of the battery configuration are omitted.

[0076] The electronic assembly 415 includes one or more sensors and a processor configured to receive and process information from the sensors related to the status and functionality of the implantable reporting processor 404 and the status of the patient in which the implantable reporting processor is implanted. The electronic assembly 415 is further configured to transmit the processed information to an external device through an antenna 419. The electronic assembly 415 may be configured as described above and shown in Figures 14A and 14B. Accordingly, details of the electronic assembly 415 will be omitted. The antenna 419 may be configured as described below in the antenna design section of this disclosure.

[0077] In some embodiments, during assembly, the cover 411 is backfilled with epoxy (fill and bleed ports not shown). The epoxy material encapsulates the antenna 419 within the cover 411. The epoxy material may be a medical grade silicone. Encapsulating the antenna 419 increases the structural rigidity of the portion of the implantable reporting processor 404 that extends from the receptacle 412 of the tibial component 400 and isolates the antenna from tissue and bodily fluids.

[0078] Antenna Design As shown in Figures 20A-20E, the component assemblies and integrated IRP antenna disclosed above are designed to transmit information generated by the IRP electronics assembly to a remote destination outside the body of a subject in which the intelligent implant is implanted, and to receive information from a remote source outside the body of the subject. In some embodiments, the antenna 208, 318, 419, 748, 786 is a flat ribbon 902 configured into a loop 904 having a curved end 906, a flat end 908 opposite the curved end, and a pair of opposing sides 910, 912 extending between the curved end and the flat end. The flat ribbon 902 forming the antenna 208, 318, 419, 748, 786 has a major surface 914 and a minor edge 916.

[0079] As shown in FIGS. 20B-20E, the antenna 208, 419 is for use with the IRP of FIGS. 7A and 7B or the IRP of FIGS. 4A and 4B. In one exemplary embodiment, the antenna has a loop length ( lp ), 7.101mm (0.276 inch) loop width (w lp ), a radius of curvature (r) at curved end 906 of 0.138 inches, a thickness (t) of 0.0050 inches, and a height (h) of 0.059 inches. As shown in FIG. 20C, the loop region ( lp ×w lp ) is approximately 138.52 mm 2 (0.222 in 2 ). As shown in FIG. 20D, the total length (l tot ) is 48.565 mm (1.912 inches). Therefore, the cross-sectional area (l tot ×h) is approximately 72.8475mm 2 (0.113 square inches).

[0080] Continuing to refer to FIGS. 20B-20E, in another exemplary embodiment in which the antenna 318,748 may be for use with the IRP of FIGS. 12A and 12B or the IRP of FIGS. 16A and 16B, the antenna has a loop length ( lp ), 8.128mm (0.32 inch) loop width (w lp ), a radius of curvature (r) at curved end 906 of 0.16 inches, a thickness (t) of 0.0050 inches, and a height (h) of 0.059 inches. lp ×w lp ) is approximately 61.93 mm 2 (0.096 in 2 ). As shown in FIG. 9D, the total length (l tot ) is 21.3687 mm (0.841 in). Therefore, the cross-sectional area (l tot×h) is approximately 32.05 mm 2 (0.0496 square inches).

[0081] With respect to the aforementioned dimensions of the antenna 208, 318, 419, 748, 786, it is desirable to maximize the cross-sectional surface area of ​​the antenna to minimize RF energy loss due to skin effects on RF transmission while simultaneously minimizing PtIr volume and thereby cost. The thickness of the flat ribbon 902 represents an approximate minimum to maintain the antenna shape during assembly, and the height (h) of the flat ribbon is such as to achieve the required surface area.

[0082] 8A and 8B, the antenna 208 is positioned within the housing cover 210 with an orientation in which the antenna's main surface 914 is generally parallel to the inner surface 508 of the cover 210 along the length of the opposing sides 910, 912 and curved end 906 of the loop 904. Generally parallel refers to the relationship between adjacent surfaces facing each other, where one surface is parallel to the other or within some range of parallel, e.g., within 25 degrees. To this end, the cover 210 includes a dome-shaped closed end 510 and a sidewall portion 512 extending from the dome-shaped closed end, where the curved end 906 of the antenna 208 is located at the dome-shaped closed end, while the opposing sides of the antenna are surrounded by the sidewalls. Orienting the antenna's major surface 914 generally parallel to the inner surface 508 of the cover 210 maximizes the area inside the antenna's flat ribbed loop, which in turn maximizes the amount of magnetic flux that can flow through the open area, providing improved antenna performance.

[0083] The orientation of the antenna 208 may also be described in terms of the antenna itself. For example, as shown in Figures 8A, 8B, and 20A-20C, the antenna 208 is disposed within the housing cover 210 with the antenna's major surface 914 oriented to face an axis 926 that runs through the center of the loop 904, the axis being perpendicular to the plane enclosed by the loop 904. In other words, the major surface 914 is in a plane that is generally parallel to an axis perpendicular to the area enclosed by the loop. Or, alternatively stated, the antenna 208's major surface 914 is in a plane that is generally perpendicular to the plane bounded by the loop 904. Generally perpendicular refers to the relationship between the planes, where one plane is perpendicular to the other, or within some range of perpendicular, e.g., within 25 degrees. Again, this orientation of the antenna's major surface 914 maximizes the area inside the loop of the antenna, which in turn maximizes the amount of magnetic flux that can flow through the open area, providing improved antenna performance.

[0084] As shown in Figures 8A, 8B, and 20A-20C, the flat end 908 of the antenna 208 electrically couples to the electronic assembly 206. To this end, the flat end 908 of the antenna 208 includes a first portion 918 separated by a gap from a second portion 920. The first portion 918 includes a first notch 922 at an edge configured to couple with the first feedthrough pin 514 of the electronic assembly 206. The second portion 920 includes a second notch 924 at an edge configured to couple with the second feedthrough pin 516 of the electronic assembly.

[0085] The above disclosed placement, orientation, and electrical coupling of the antenna 208 of the implantable reporting processor 104 shown in Figures 8A and 8B also describes the placement, orientation, and electrical coupling of the antenna 318 of the implantable reporting processor 304 shown in Figures 12A and 12B, the antenna 419 of the implantable reporting processor 404 shown in Figures 4A and 4B, the antenna 748 of the implantable reporting processor 404 shown in Figures 16A and 16B, and the antenna 786 of the implantable reporting processor 144 shown in Figure 19. Accordingly, details of the placement, orientation, and electrical coupling of these antennas will be omitted.

[0086] With regard to the materials and surface finish of the antenna 208, 318, 419, 748, 786, in some embodiments the antenna is formed of a material including platinum (Pt) having an atomic percentage ranging from 70% to 100% and iridium (Ir) having an atomic percentage ranging from 0% to 30%. In one exemplary configuration, the antenna 208, 318, 419, 748, 786 is formed from Pt90Ir10. Platinum and Pt-Ir alloys are selected for their combination of biocompatibility, ductility, and electrical conductivity.

[0087] In some embodiments, the major surface 914 of the antenna 208, 318, 419, 748, 786 has a surface finish ranging from 0 microinches up to 15 microinches. In one exemplary configuration, the surface finish is up to 6 microinches.

[0088] As mentioned above, in the IRP configuration, the antenna 208, 318, 419, 748, 786 is coupled to the electronics assembly through a dielectric feedthrough, with a dielectric PEEK cover and backfill that encases the antenna. The backfill may be silicone or a medical epoxy adhesive. The incorporation of the antenna into the dielectric combined with the post-implant placement of the antenna in bone tissue and muscle may affect the performance of the antenna. However, the antenna 208, 318, 419, 748, 786 design, e.g., geometry, orientation, material composition, surface finish, etc., disclosed herein in combination with the circuitry of the electronics assembly 206 allows for post-implant communication at both 2.45 GHz and Medical Implant Communication System (MICS) frequency bands, e.g., 401-406 MHz, despite the surrounding presence of dielectrics and tissue.

[0089] In one configuration, a loop antenna 208 having the physical characteristics described above with reference to Figures 20A-20E is tuned to allow post-implant reception of an ultra-low power wake-up sniff signal on a 2.45 GHz channel, while allowing post-implant reception as well as transmission of data and information on a MICS channel, e.g., a 400 MHz channel. To this end, referring to Figure 21, one end of the antenna 208 is coupled to a DC blocking capacitor 2002 and the other end is grounded 2004. The DC blocking capacitor 2002 is coupled to a parallel signal path including a 2.45 GHz signal path 2006 and a 400 MHz signal path 2008.

[0090] The 2.45 GHz path 2006 includes a 2.45 GHz matching network 2010. The 2.45 GHz matching network 2010 is coupled to a 2.45 GHz input port of the transceiver 2012 and provides a 2.45 GHz signal to the transceiver 2012. The 2.45 GHz matching network 2010 matches the impedance of the antenna 208 to the impedance of the 2.45 GHz input of the transceiver to enable communication of the wake-up signal on the 2.45 GHz channel. In some embodiments, the matching impedance is greater than 50 ohms. In some embodiments, the matching impedance is greater than 100 ohms. In some embodiments, the matching impedance is greater than 500 ohms. In some embodiments, the matching impedance is in the range of 100 ohms to 800 ohms.

[0091] The 400 MHz signal path 2008 includes a 2.45 GHz notch filter 2014, a MICS matching network 2016, a SAW bandpass filter 2018, and a matching element 2020 coupled to the 400 MHz input and output ports of the transceiver 2012. The 2.45 GHz notch filter 2008 rejects the 2.45 GHz signal from the 400 MHz path. The SAW bandpass filter 2018 further filters the signal to reduce out of band signals entering the transceiver 2012 on the 400 MHz signal path 2008.

[0092] The MICS matching network 2016 includes one or more circuit components and, in some embodiments, is firmware tunable via a first matching port and a second matching port of the transceiver 2012. The MICS matching network 2016, together with a matching element 2020 at the MICS input of the transceiver 2012, matches the impedance of the antenna 208 to the impedance of the MICS input and output to enable communication on a 400 MHz channel. In some embodiments, the matching impedance at the input of the SAW bandpass filter 2018 set by the MICS matching network 2016 is greater than 50 ohms. In some embodiments, the matching impedance at the input of the SAW bandpass filter 2018 is greater than 100 ohms. In some embodiments, the matching impedance at the input of the SAW bandpass filter 2018 is in the range of 100 ohms to 500 ohms. In some embodiments, the matching impedance at the MICS input of the transceiver 2012 set by the matching element 2020 is greater than 10 ohms. In some embodiments, the matched impedance at the MICS input of the transceiver 2012 is in the range of 10 ohms to 200 ohms.

[0093] Electronic Assembly Referring to the block diagram of FIG. 22, the implantable reporting processor 1003 includes an electronic assembly 1010, a battery 1012 or other suitable implantable power source, and an antenna 1030. The electronic assembly 1010 comprises a circuit assembly including fuses 1014, switches 1016, 1017, and 1018, a clock generator and clock and power management circuit 1020, an inertial measurement unit (IMU) 1022, a memory circuit 1024, a radio frequency (RF) transceiver 1026, an RF filter 1028, and a controller 1032. The electronic assembly 1010 may also include an accelerometer 1023. The accelerometer 1023 may be a single-axis or multi-axis accelerometer, and in one embodiment, is a three-axis accelerometer. Examples of some or all of these components are described in the present application, WO 2017 / 165717, WO 2020 / 247890, which are incorporated by reference.

[0094] The battery 1012 may be any suitable battery, such as a lithium carbon monofluoride (LiCFx) battery or other storage cell configured to store energy to power the electronic assembly 1010 for the expected life of the kinematic implant (e.g., 5-25 years or more).

[0095] The fuse 1014 may be any suitable fuse (e.g., permanent) or circuit breaker (e.g., resettable) configured to prevent the battery 1012, or current flowing from the battery, from damaging the patient and / or damaging one or more components of the battery and electronic assembly 1010. For example, the fuse 1014 may be configured to prevent the battery 1012 from generating enough heat to burn the patient, damage the electronic assembly 1010, damage the battery, or damage structural components of the kinematic implant.

[0096] The switch 1016 is configured to couple the battery 1012 to the IMU 1022 or decouple the battery from the IMU 1022 in response to a control signal 1034 from the controller 1032. For example, the controller 1032 may be configured to generate a control signal 1034 having an open state that causes the switch 1016 to open, thus decoupling power from the IMU 1022 during a sleep mode or other low power mode to conserve power and therefore extend the life of the battery 1012. Similarly, the controller 1032 may also be configured to generate a control signal 1034 having a closed state that causes the switch 1016 to close, thus coupling power to the IMU 1022 when waking up from a sleep mode or exiting another low power mode. Such a low power mode may be for only the IMU 1022 or for the IMU and one or more other components of the implantable reporting processor 1003.

[0097] The switch 1017 is configured to couple the battery 1012 to the accelerometer 1023 or decouple the battery from the accelerometer 1023 in response to a control signal 1036 from the controller 1032. For example, the controller 1032 may be configured to generate a control signal 1036 having an open state that causes the switch 1017 to open, thus decoupling power from the accelerometer 1023 during sleep mode to conserve power and therefore extend the life of the battery 1012. Similarly, the controller 1032 may also be configured to generate a control signal 1036 having a closed state that causes the switch 1017 to close, thus coupling power to the accelerometer 1023 upon “waking up” from sleep mode.

[0098] The switch 1018 is configured to couple the battery 1012 to the memory circuit 1024 or decouple the battery from the memory circuit 1024 in response to a control signal 1038 from the controller 1032. For example, the controller 1032 may be configured to generate a control signal 1038 having an open state that causes the switch 1018 to open, thus decoupling power from the memory circuit 1024 during a sleep mode or other low power mode to conserve power and therefore extend the life of the battery 1012. Similarly, the controller 1032 may also be configured to generate a control signal 1038 having a closed state that causes the switch 1018 to close, thus coupling power to the memory circuit 1024 when waking up from a sleep mode or exiting another low power mode. Such a low power mode may be for only the memory circuit 1024 or for the memory circuit and one or more other components of the electronic assembly 1010.

[0099] The clock circuit 1020 is configured to generate clock signals for one or more of the other components of the electronic assembly 1010, and may be configured to generate periodic commands or other signals (e.g., interrupt requests) in response to the controller 1032 causing one or more components of the implantable circuit to enter or exit a sleep mode or other low power mode. In some embodiments, the clock circuit 1020 is also configured to regulate the voltage from the battery 1012 and provide a regulated power supply voltage to some or all of the other components of the electronic assembly 1010. In these embodiments, the clock circuit 1020 may be referred to as a clock and power management circuit.

[0100] The IMU 1022 may be configured to have a reference frame having coordinates x, y, and z axes, and to measure or otherwise quantify the linear acceleration the IMU experiences along each of the x, y, and z axes, as well as the angular velocity (or rotational motion) the IMU experiences about each of the x, y, and z axes. This configuration of the IMU 1022 allows the IMU 1022 to measure six unique quantities: x (g), a y(g), a z (g), Ωx(dps), Ω y (dps), and Ω z In order to measure (dps), the IMU must have at least a 6-axis configuration. Alternatively, the IMU 1022 can use the earth magnetic field to measure the a x (g), a y (g), az(g), Ωx(dps), Ωy(dps), and Ω z The IMU may be configured in a 9-axis configuration, which may compensate or otherwise correct for accumulated errors of up to 1000 dps. However, in an embodiment where the IMU measures acceleration and angular velocity over only short bursts (e.g., 0.10 to 100 seconds(s)), for many applications the accumulated errors can typically be ignored without exceeding the respective error tolerances.

[0101] The IMU 1022 may include a respective analog-to-digital converter (ADC) for each of the x, y, and z accelerometers and gyroscopes. Alternatively, the IMU 1022 may include only one ADC for each of the x, y, and z accelerometers and gyroscopes, and one ADC shared by the accelerometers and gyroscopes, respectively. Including fewer than one ADC per accelerometer and gyroscope may reduce the size and / or circuit density of the IMU 1022 and may reduce the power consumption of the IMU. However, because the IMU 1022 includes a respective sample-and-hold circuit for each accelerometer and each gyroscope, samples of the analog signals generated by the accelerometers and gyroscopes may be taken at the same or different sample times, the same or different sample rates, and the same or different output data rates (ODR).

[0102] The accelerometer 1023 is configured to monitor acceleration in a low power state. The accelerometer 1023 may be a single-axis or multi-axis accelerometer, and in one embodiment, is a tri-axis accelerometer. In the case of a tri-axis configuration, the accelerometer 1023 may include a respective ADC for each of the x, y, and z accelerometers. Alternatively, the accelerometer 1023 may include a respective sample-and-hold circuit for each of the x, y, and z accelerometers, with as few as one ADC shared by the accelerometers. Including fewer than one ADC per accelerometer may reduce the size and / or circuit density of the accelerometer 1023, and may reduce the power consumption of the accelerometer 1023. Based on the acceleration signal it senses, the accelerometer 1023 may detect motion events. For example, the accelerometer may be configured to detect simple motion events, such as footing or shoulder swings, and count such detections. The accelerometer may be configured to detect significant motion, such as walking or arm swinging motions. The accelerometer 1023 is configured to provide a wake-up signal to the controller 1032 when significant movement is detected.

[0103] The memory circuit 1024 may be any suitable non-volatile memory circuit, such as an EEPROM or FLASH memory, and may be configured to store data written by the controller 1032 and to provide data in response to read commands from the controller.

[0104] The RF transceiver 1026 may be a conventional transceiver configured to enable the controller 1032 (and optionally the fuse 1014) to communicate with a base station (not shown in FIG. 22) configured for use with the kinematic implantable device. For example, the RF transceiver 1026 may be any suitable type of transceiver (e.g., Bluetooth, Bluetooth Low Energy (BTLE), and WiFi), may be configured to operate according to any suitable protocol (e.g., MICS, ISM, Bluetooth, Bluetooth Low Energy (BTLE), and WiFi), and may be configured to operate in a frequency band within the range of 1 MHz to 5.4 GHz, or any other suitable range.

[0105] The RF filter 1028 may be any suitable bandpass filter, such as a surface acoustic wave (SAW) filter or a bulk acoustic wave (BAW) filter. In some embodiments, the RF filter 1028 includes multiple filters and other circuits to enable dual-band communication. For example, the RF filter 1028 may include a bandpass filter for communication on a MICS channel and a notch filter for communication on a different channel, such as 2.45 GHz, with reference to FIG. 21.

[0106] The antenna 1030 may be any antenna suitable for the frequency band in which the RF transceiver 1026 generates signals for transmission by the antenna and in which the base station generates signals for reception by the antenna, in some embodiments the antenna 1030 is configured as a flat ribbon loop antenna, as described above with reference to Figures 20A-20E.

[0107] The controller 1032, which may be any suitable microcontroller or microprocessor, is configured to control the configuration and operation of one or more of the other components of the electronic assembly 1010. For example, the controller 1032 is configured to control the IMU 1022 to obtain measurements of the movement of the implantable medical device with which the electronic assembly 1010 is associated, quantify the quality of such measurements (e.g., measurements "good" or "bad"), store measurement data generated by the IMU in the memory 1024, generate messages that include the stored data as payloads, and provide the message packets to the RF transceiver 1026 for packetization and transmission to an external device, e.g., a base station. The controller 1032 may be configured to execute commands received from an external device via the antenna 1030, the RF filter 1028, and the RF transceiver 1026. For example, the controller 1032 may be configured to receive configuration data from a base station and provide the configuration data to components of the electronic assembly 1010 to which the base station directs the configuration data. When the base station directs configuration data to the controller 1032, the controller is configured to configure itself in response to the configuration data. The controller 1032 may also be configured to perform data sampling by the IMU 1022 according to one or more programmed sampling schedules or in response to on-demand data sampling commands received from the base station. For example, as described below, the portable reporting processor 104 may be programmed to operate according to a master sampling schedule and a periodic, e.g., daily, sampling schedule.

[0108] Inertial Measurement Unit Figure 23 is a perspective view of the IMU 1022 of Figure 22, according to one embodiment. For example, the IMU 1022 may be a Bosch BMI160 small, low power, IMU.

[0109] 22, the IMU 1022 includes three measurement axes 1060, 1062, and 1064, which for purposes of explanation are arbitrarily labeled x, y, and z. That is, in a Cartesian coordinate system, the labels "x," "y," and "z" may be arbitrarily applied to the axes 1060, 1062, and 1064 in any order or arrangement. Markings 1066 are references that indicate the location and orientation of the axes 1060, 1062, and 1064 relative to the IMU 1022 package.

[0110] The IMU 1022 includes three accelerometers (not shown in FIG. 23 ), each of which senses and measures linear acceleration a(t) along a respective one of axes 1060 (x), 1062 (y), and 1064 (z), where a x (t) is the acceleration along the x-axis, and a y (t) is the acceleration along the y-axis, and a z (t) is the acceleration along the z-axis. Each accelerometer generates a respective analog sensed or output signal having an instantaneous magnitude that represents the instantaneous magnitude of the sensed acceleration along the corresponding axis. For example, the magnitude of the accelerometer output signal at a given time is proportional to the magnitude of the acceleration along the accelerometer's sensed axis at that same time.

[0111] The IMU 1022 also includes three gyroscopes (not shown in FIG. 23), each of which senses and measures angular velocity Ω(t) about a respective one of the axes 1060 (x), 1062 (y), and 1064 (z), where Ω x (t) is the angular velocity along the x-axis, and Ω y (t) is the angular velocity along the y-axis, and Ω z (t) is the angular velocity along the z-axis. Each gyroscope generates a respective analog sense or output signal having an instantaneous magnitude that represents the instantaneous magnitude of the sensed angular velocity about the corresponding axis. For example, the magnitude of the gyroscope output signal at a given time is proportional to the magnitude of the angular velocity about the gyroscope's sense axis at that same time.

[0112] The IMU 1022 includes at least two analog-to-digital converters (ADCs) (not shown in FIG. 23) for each axis 1060, 1062, and 1064, one ADC for converting a corresponding accelerometer output signal into a corresponding digital acceleration signal, and the other ADC for converting a corresponding gyroscope output signal into a corresponding digital angular rate signal. For example, each of the ADCs may be an 8-bit, 16-bit, or 24-bit ADC.

[0113] Each ADC (not shown in FIG. 23) may be configured to have respective parameter values ​​that are the same as or different from the parameter values ​​of the other ADCs. Examples of such parameters having configurable values ​​include the sampling rate, the dynamic range at the ADC input node(s), and the output data rate (ODR). One or more of these parameters may be set to a fixed value, while one or more of these parameters may be dynamically (e.g., during run-time) configurable. For example, the respective sampling rate of each ADC may be dynamically configurable such that during one sampling period the sampling rate has one value and during another sampling period the sampling rate has another value.

[0114] For each digital acceleration signal and each digital angular rate signal, the IMU 1022 may be configured to provide parameter values ​​associated with the signal. For example, the IMU 1022 may provide, for each digital acceleration signal and for each digital angular rate signal, a sampling rate, a dynamic range, and a timestamp indicating when the first or last sample was taken. The IMU 1022 may be configured to provide these parameter values ​​in the form of a message header (with the corresponding samples forming the message payload) or in any other suitable form.

[0115] accelerometer As discussed above in conjunction with FIG. 22, accelerometer 1023 includes three accelerometers, each of which senses and measures linear acceleration a(t) along a respective one of axes 1060(x), 1062(y), and 1064(z), where a x (t) is the acceleration along the x-axis, and a y (t) is the acceleration along the y-axis, and a z (t) is acceleration along the z-axis. These three measurement axes 1060, 1062, and 1064 are shown in FIG. 23. Each accelerometer produces a respective analog sensed or output signal having an instantaneous magnitude that represents the instantaneous magnitude of the sensed acceleration along the corresponding axis. For example, the magnitude of the accelerometer output signal at a given time is proportional to the magnitude of acceleration along the accelerometer's sense axis at the same time. Accelerometer 1023 can be a Bosch BMA400 accelerometer.

[0116] Accelerometer 1023 includes an ADC for each axis 1060, 1062, and 1064 for converting the corresponding accelerometer output signal into a corresponding digital acceleration signal. For example, each of the ADCs may be an 8-bit, 16-bit, or 24-bit ADC.

[0117] Each ADC may be configured to have respective parameter values ​​that are the same as or different from the parameter values ​​of the other ADCs. Examples of such parameters having configurable values ​​include sampling rate, dynamic range at the ADC input node(s), and output data rate (ODR). One or more of these parameters may be set to a fixed value, while one or more of these parameters may be dynamically (e.g., during run-time) configurable. For example, the respective sampling rate of each ADC may be dynamically configurable such that during one sampling period the sampling rate has one value and during another sampling period the sampling rate has another value.

[0118] For each digital acceleration signal, the accelerometer 1023 may be configured to provide parameter values ​​associated with the signal. For example, the accelerometer 1023 may provide, for each digital acceleration signal, a sampling rate, a dynamic range, and a timestamp indicating when the first or last sample was taken. The accelerometer 1023 may be configured to provide these parameter values ​​in the form of a message header (with the corresponding samples forming the message payload), or in any other suitable form.

[0119] Knee movement data 24 is an illustration of a set of coordinate axes of the IRP IMU for a patient implanted with a knee prosthesis 1072. Relative to the patient's anatomy, the positive portion of the x-axis 1060 extends in an outward direction away from the leg. In other words, the positive portion of the x-axis 1060 extends away from the patient's other leg. The positive portion of the y-axis 1062 extends in a downward direction toward the patient's foot. The positive portion of the z-axis 1064 extends in an outward direction from the posterior of the patient's knee.

[0120] FIG. 25A shows the x-axis 1060, while the patient 1070 is walking forward at a normal gait at a speed of 0.9 meters / second and for approximately 10 seconds. y Axis 1062, and z Analog acceleration signals a, b, c, and d as a function of time generated by the accelerometers of the IMU 1022 in response to acceleration along the axis 1064 x 2 is a plot 2500 of digitized versions of ay(g), ay(g), and az(g) versus time. In this example, the IMU 1022 receives an analog acceleration signal a x (g), a y (g), and zEach of (g) is sampled at the same sample time, the sampling rate is 3200 Hz, and the output data rate (ODR) is 800 Hz. The ODR is the rate of samples output by the IMU 1022 and is generated by downsampling the samples taken at 3200 Hz. That is, 3200 Hz / 800 Hz=4, so the IMU 1022 generates an ODR of 800 Hz by outputting only every fourth sample taken at 3200 Hz.

[0121] FIG. 25B illustrates the analog angular rate signal Ω as a function of time generated by the gyroscopes of the IMU 1022 in response to angular rates about the x-axis 1060, y-axis 1062, and z-axis 1064, respectively, while the patient 1070 is walking forward at a normal gait at a speed of 0.5 meters / second for approximately 10 seconds. x (dps), Ω y (dps), and Ω z 2 is a plot 2502 of a digitized version of the analog angular rate signal Ω (dps) versus time. In this example, the IMU 1022 x (dps), Ω y (dps), and Ω z (dps), as well as the analog acceleration signal a x (g), a y (g), and z Each of (g) is sampled at the same sample time and with the same sampling rate of 3200 Hz and ODR of 800 Hz, i.e. plot 2502 is aligned in time with plot 2500 of FIG.

[0122] As briefly described below, in PCT Publication Nos. WO2014 / 209916, WO2016 / 044651, WO2017 / 165717, and WO2020 / 247890, the acceleration and angular velocity signals provided by the IMU 1022 may be processed to determine kinematic information of the patient. For example, the signals may be processed to determine a set of gait parameters including range of motion, step rate, cadence, stride, and distance traveled. In general, there are three types of three-dimensional motion that an intelligent implant can detect in and around a joint: core gait (or limb mobility in the case of shoulder or elbow arthroplasty), macroscopic instability, and microscopic instability. For more information on these types of motion, see PCT Publication Nos. WO2017 / 165717 and WO2020 / 247890.

[0123] The number of steps, distance traveled, and frequency represent measures of activity and robustness of activity. The range of motion of the tibia (TIBI) calculated from the gyroscope data represents the average global dynamic rotation of the tibia relative to the ground in the sagittal plane over 10-15 steps. Briefly, this can be thought of as the global arc of a pendulum moving translationally in the sagittal plane. The range of motion (ROM) of the knee 膝関節 ) represents the average sagittal plane dynamic envelope angle between the hip, femur, and tibia over a stride. This calculation combines a combination of published tabulated data for hip and femur position stratified for sex, age, and BMI with implant ROM tibia data. This value has the same meaning as the standard of care, clinician-static, goniometer measurements made during a physical exam. However, it represents the actual dynamic range of motion during normal weight-bearing activities, as opposed to the static, full-ability range of motion assessed during a physical exam. Cadence, Stride, ROM 脛骨 , and ROM 膝 Each value is an average calculated based on data collected over a 24-hour period.

[0124] Shoulder movement data 26 is an illustration of a set of IRP IMU coordinate axes for a patient 1070 implanted with a shoulder prosthesis 1074. With respect to the patient's anatomy, the positive portion of the x-axis 1060 extends in an anterior direction from the shoulder. The positive portion of the y-axis 1062 extends outward from the patient's shoulder. The positive portion of the z-axis 1064 extends in an upward direction from the patient's shoulder.

[0125] FIG. 27A shows the x-axis 1060, y-axis 1062, or z The analog angular rate signal Ω as a function of time generated by the gyroscope of the IMU 1022 in response to the angular rate about the axis 1064 x (dps), Ω y 27B is a plot 2700 of the x-axis 1060, y-axis 1062, or Ωz(dps) versus time while the patient 1070 is performing an external rotation movement. z 1. The analog angular rate signal Ω as a function of time generated by the gyroscope of the IMU 1022 in response to the angular rate about the axis 1064. x (dps), Ω y 27C is a plot 2702 of the x-axis 1060, y-axis 1062, or Ωz(dps) versus time while a patient 1070 is performing a walking arm swing motion. z 1. The analog angular rate signal Ω as a function of time generated by the gyroscope of the IMU 1022 in response to the angular rate about the axis 1064. x (dps), Ω y 27 is a plot 2704 of the digitized version of Ωz(dps), or Ωz(dps), versus time.

[0126] Hip joint movement data 28 is an illustration of a set of IRP IMU coordinate axes for a patient 1070 implanted with a hip prosthesis 1076. With respect to the patient's anatomy, the positive portion of the x-axis 1060 extends outward from the patient's hips. The positive portion of the y-axis 1062 extends downward from the patient's hips. The positive portion of the z-axis 1064 extends forward from the patient's hips.

[0127] Analog acceleration signals a generated by the accelerometer of the IMU 1022 of the prosthetic hip joint 1076 in response to acceleration along the x-axis 1060, y-axis 1062, and z-axis 1064, respectively, while the patient 1070 is moving forward at a normal gait at a speed of 0.9 meters / second. x A plot of the digitized versions of ay(g), ay(g), and az(g) is similar to the plot shown in FIG. 25A. The x-axis 1060, y-axis 1062, and z Analog angular rate signals Ω x , x , generated by the gyroscopes of the IMUs 1022 of the artificial hip joints 1076 in response to the angular rate about the axis 1064. x (dps), Ω y Plots of the digitized versions of Ωz(dps) and Ωz(dps) are similar to the plot shown in FIG. 25B.

[0128] Intelligent implant operation modes / states In some embodiments, the IRP 1003 of the intelligent implant is configured to be placed into five different operational modes, including:

[0129] Deep Sleep Mode: This mode places the IRP 1003 in an ultra-low power state during storage to maintain shelf life prior to implantation. In this mode, only the Clock and Power Management 1020 circuitry and the RF Transceiver 1026 wake-up circuitry are active. To this end, and referring to FIG. 22, the battery 1012 provides power to the Clock and Power Management circuitry 1020, and the RF Transceiver 1026 and switches 1016, 1017, 1018 are open to isolate the battery 1012 from the IMU 1022, accelerometer 1023, and memory circuitry 1024.

[0130] Standby Mode: This mode puts the IRP1003 into a low power state during which the implant is ready for wireless communication with external devices.

[0131] Low Resolution Mode: During this mode, the IRP 1003 detects and counts simple motion events (e.g., footing, shoulder sway, etc.) and collects low resolution linear acceleration data to detect significant motion. In some embodiments, the low resolution mode is characterized by the activation of a first sensor set of sensors that allows detection of simple motion events, e.g., the individual accelerometer 1023 or one or more accelerometers of the IMU 1022, using a sampling rate in the range of 12 Hz to 100 Hz. To this end, one of the switches 1016, 1017 is closed to couple the battery 1012 to the IMU 1022 or the individual accelerometer 1023, as shown in FIG. 22.

[0132] When in low resolution mode, the first set of sensors counts simple motion events and sends significant motion notifications to the controller 1032. When exiting low resolution mode, the IMU 1022 or individual accelerometer 1023 reports the number of simple motion events to the controller 1032. Low resolution mode may be entered at scheduled times and exited at scheduled times according to a sampling schedule. During low resolution mode, data is collected continuously by the first set of sensors.

[0133] Medium Resolution Mode: During this mode, the IRP 1003 collects both linear acceleration and rotational motion data. In some embodiments, the medium resolution mode is characterized by the activation of a second set of sensors of the IMU 1022, e.g., three accelerometers and three gyroscopes, that allow detection of linear acceleration and rotational rate using a sampling rate in the range of 12 Hz to 100 Hz. 12 Hz 100 Hz To this end, and referring to FIG. 22, the switch 1016 is closed to couple the battery 1012 to the IMU 1022.

[0134] The medium resolution mode may be initiated when unspecified detection of a significant motion event occurs during a configured medium resolution window of a day, or by a manual command transmitted wirelessly from an external device, e.g., a base station. The medium resolution mode may be terminated after a predefined event associated with a detected significant motion. For example, in the case of significant motion corresponding to walking, the predefined event may be several steps. In the case of significant motion corresponding to arm pivoting, the predefined event may be several rotations. The medium resolution mode may be terminated after failure to detect significant motion.

[0135] High Resolution Mode: During this mode, the IRP 1003 may collect linear acceleration data or may collect both linear acceleration and rotational motion data. In some embodiments, the high resolution mode is characterized by the activation of a third set of sensors, such as the three accelerometers of the IMU 1022 (when collecting only acceleration data), or the three accelerometers and three gyroscopes of the IMU (when collecting both acceleration and rotational motion data), allowing detection of acceleration and rotational motion data using a sampling rate in the range of 200Hz to 5000Hz. 200Hz 5000Hz To this end, and referring to FIG. 22, the switch 1016 is closed to couple the battery 1012 to the IMU 1022.

[0136] High resolution mode can be initiated when a specific detection of a significant motion event occurs during a configured medium resolution window of day, or by a manual command sent wirelessly from an external device. High resolution mode has a built-in time limit after which acquisition is automatically terminated.

[0137] These five modes are used to collect data passively and autonomously at various frequencies during the life of the intelligent implant, without the patient's involvement. The intelligent implant may start collecting data on the second postoperative day and has the ability to store up to 30 days of data in memory. After that, the data is transmitted to the cloud daily. If data cannot be transmitted due to connection issues with the base station and the implant reaches its memory limit, new data will overwrite the oldest data. Additionally, the base station can store up to 45 days of transmitted data if it cannot connect to the cloud but can still communicate with the implant locally.

[0138] Data Sampling and Scheduling With reference to Fig. 29, a method of sampling data from an implantable reporting processor (IRP) of an intelligent implant in the form of a knee prosthesis is described. The method may be implemented by the implantable reporting processor 1003 of Fig. 22 configured to sample data in each of a low resolution mode, a medium resolution mode, and a high resolution mode. As previously described, the low resolution mode may be characterized by the activation of a first set of sensors of the IRP 1003 that allows for detection of steps using a sampling rate in the range of 12Hz to 100Hz, the medium resolution mode may be characterized by the activation of a second set of sensors of the IRP that allows for detection of acceleration and rotational velocity using a sampling rate in the range of 12Hz to 100Hz, and the high resolution mode is characterized by the activation of a third set of sensors of the IRP that allows for detection of acceleration using a sampling rate in the range of 200Hz to 5000Hz.

[0139] Continuing with FIG. 29, at block 1702, a sampling session begins. The sampling session may be scheduled to occur based on a master sampling schedule programmed into the IRP 1003. In some embodiments, the master sampling schedule has a duration of years from a calendar start date. For example, the number of years may be three years. The master sampling schedule includes a calendar schedule that defines when data sampling occurs. In one embodiment, the periodic sampling is daily sampling performed according to a daily sampling schedule. Thus, in this embodiment, the method of sampling data of FIG. 29 may occur daily. The IRP 1003 is configured to allow for overriding of the master sampling schedule.

[0140] At block 1704, the IRP 1003 determines whether the current time is within a low-resolution window established by the daily sampling schedule. The low-resolution window may be defined by a start time and an end time. The low-resolution window may be a portion of a 24-hour period and may have an associated duration limit. For example, the low-resolution window may be limited to a maximum duration of 18 hours.

[0141] If, at block 1706, the IRP 1003 determines that the current time is within the low-resolution window, the process proceeds to block 1706 where the IRP performs low-resolution sampling using the first set of sensors. Alternatively, if the IRP 1003 determines that the current time is not within the low-resolution window, the process proceeds to block 1718 where the sampling session ends.

[0142] Returning to block 1706, the IRP 1003 performs low-resolution sampling during the low-resolution window by detecting and counting the patient's steps. The low-resolution sampling may be continuous throughout the low-resolution window. To this end, the IRP 1003 may enable a first set of sensors to provide signal samples from which the patient's steps may be detected. The first set of sensors may be an accelerometer of the IMU 1022 or a separate accelerometer 1023. The low-resolution sampling rate may be in the range of 12 Hz to 100 Hz. In some embodiments, the IRP 1003 maintains a cumulative count of steps detected during each of multiple portions of the low-resolution window in its memory circuit 1024. For example, the IRP 1003 may maintain a cumulative count of steps for each time of the low-resolution window.

[0143] Continuing with FIG. 29, at block 1708, the IRP 1003 determines whether the current time is within a medium resolution window established by the daily sampling schedule. The IRP 1003 makes this "determination" concurrently with the low resolution mode sampling. The medium resolution window may be defined by a start time and an end time, with the start time of the medium resolution window being within the low resolution window. In some embodiments, the daily sampling schedule defines multiple different medium resolution windows, each of which is defined by a start time and an end time within the low resolution window. There may be a maximum number of allowable individual medium resolution windows within the daily sampling schedule. For example, in one configuration, there are a maximum of three individual medium resolution windows. These individual medium resolution windows may be scheduled to be spaced apart within the daily schedule, or may be scheduled such that there is some overlap between the windows. In some embodiments, the duration of each individual medium resolution window is in the range of 1-4 hours. In some embodiments, the period of the medium resolution window is 3 hours.

[0144] If, at block 1708, IRP 1003 determines that the current time is within the medium resolution window and that medium or high resolution data has not yet been collected, the process proceeds to block 1710, where the IRP detects significant motion events in addition to continuing step counting. Alternatively, if IRP 1003 determines that the current time is not within the medium resolution window or that scheduled medium and high resolution data have already been collected, the process returns to block 1704, where the IRP determines whether the current time is still within the low resolution window.

[0145] If the IRP 1003 determines that the current time is within the medium resolution window and that medium or high resolution data has not yet been collected, then in block 1710, the IRP 1003 detects a significant motion event by sampling analog signals output from a second set of sensors. In some embodiments, the second set of sensors includes one or more of the accelerometers of the IMU 1022, or one or more of the gyroscopes of the IMU, or a separate accelerometer 1023. In the case of one or more of the accelerometers of the IMU 1022, the IMU samples the analog signals at the same sampling rate associated with the low resolution mode. For example, the IMU 1022 samples the analog signals output from all of the x, y, and z accelerometers and gyroscopes in the range of 12 Hz to 100 Hz.

[0146] Continuing with block 1710, either the controller 1032 or the IMU 1022 determines whether the samples acquired by the IMU 1022 are samples of a significant motion event, such as a patient 1070 walking with an implanted knee prosthesis 1072. Alternatively, either the controller 1032 or the accelerometer 1023 determines whether the samples acquired by the accelerometer 1023 are samples of a significant motion event, such as a patient 1070 walking with an implanted knee prosthesis 1072. In a preferred embodiment, the separate accelerometers 1023 sample the analog signals and determine whether the samples constitute a significant motion event. For example, the accelerometers 1023 are configured to compare respective samples from each of one or more of the accelerometers to a corresponding benchmark sample (e.g., FIG. 22) for a significant motion event, the correlation result to a threshold, and determine that the sample is a significant motion event if the correlation result is equal to or exceeds the threshold, or determine that the sample is not a significant motion event if the correlation result is less than the threshold, the apparatus of any one of Examples 1-10. Alternatively, the accelerometer 1023 may make a less complex and less energy consuming determination by, for example, determining that a sample is a significant motion event if the sample has a peak-to-peak amplitude and duration that may indicate the patient has been walking for a threshold length of time. In another example, the significant motion event may correspond to a change in acceleration that exceeds a threshold, and detecting the significant motion event includes detecting a first change in acceleration that exceeds the threshold and detecting a second change in acceleration that exceeds the threshold after a waiting period.

[0147] Continuing with block 1710, if the IRP 1003 does not detect a significant motion event, the process returns to block 1708, where the IRP determines whether the current time is still within the current medium resolution window and medium or high resolution data has not yet been collected. Alternatively, if the IRP 1003 detects a significant motion event, the process proceeds to block 1712, where the IRP determines whether high resolution data still needs to be collected within the current medium resolution window. The daily sampling schedule may specify whether the medium resolution window should include high resolution mode sampling.

[0148] If, at block 1712, the IRP 1003 determines that high resolution data still needs to be collected, the process proceeds to block 1714, where the IRP performs high resolution sampling. Alternatively, if the IRP 1003 determines that high resolution data does not need to be collected within the current medium resolution window, the process proceeds to block 1716, where the IRP performs medium resolution sampling.

[0149] Returning to block 1714, the IRP 1003 performs high resolution sampling by generating and storing signals indicative of three-dimensional movement. To this end, the IRP 1003 may enable a third set of sensors of the IRP 1003 to provide respective signals. The third set of sensors may be a plurality of accelerometers of the IMU 1022, with the respective signals representing acceleration information of the intelligent implant and the patient. In some embodiments, three accelerometers of the IMU 1022 are activated for high resolution sampling to provide acceleration information along three axes of the IMU. The high resolution sampling rate may be in the range of 200 Hz to 5000 Hz. This acceleration information may be processed by the controller 1032. The data may be stored in memory 1024 for subsequent transmission or transmitted to an external device for analysis based on that data and used to identify and / or address problems associated with the implanted medical device, including incorrect placement of the device, unexpected degradation of the device, and undesirable movement of the device, as described, for example, in WO 2020 / 247890, the disclosure of which is incorporated herein by reference.

[0150] In one configuration, the daily sampling schedule limits the high resolution sampling to a predetermined number of times per day. In one configuration, the number of times per day is once. The daily sampling schedule may also set the period of the high resolution sampling. For example, the high resolution sampling may occur over a duration ranging from 1 second to 10 seconds. In some embodiments, the duration of the high resolution window is 3 seconds.

[0151] Returning to block 1716, the IRP 1003 performs medium resolution sampling by generating and storing signals indicative of three-dimensional movement. To this end, the IRP 1003 may enable a number of accelerometers of the IRP and a number of gyroscopes of the IRP to provide respective signals. The signals from the accelerometers represent acceleration information of the intelligent implant and the patient, and the signals from the gyroscopes represent angular velocity information of the intelligent implant and the patient. In some embodiments, three accelerometers of the IMU 1022 are activated for medium resolution sampling to provide acceleration information along three axes of the IMU 1022. In some embodiments, three gyroscopes of the IMU 1022 are activated for medium resolution sampling to provide angular velocity information about the three axes of the IMU. Collectively, the acceleration and angular velocity information represent kinematic information of the patient. This information may be processed by the controller 1032, stored in the memory 1024 for subsequent transmission, or transmitted to an external device for processing to determine kinematic information of the patient. For example, for a knee or hip implant, a set of gait parameters may be determined including range of motion, step rate, cadence, stride length, walking speed, and distance traveled. For a shoulder implant, a set of multiple motion (ROM) parameters may be determined including abduction, flexion, horizontal addition, internal rotation, and external rotation.

[0152] The medium resolution sampling rate may be in the range of 12 Hz to 100 Hz. Medium resolution sampling may be performed a limited number of times during the medium resolution window. In one configuration, a daily sampling schedule limits medium resolution sampling to once per medium resolution window. The daily sampling schedule may also set the period of the medium resolution sampling. For example, medium resolution sampling may occur over a duration ranging from 5 seconds to 30 seconds. In some embodiments, the duration of the high resolution window is 10 seconds.

[0153] In addition to the scheduled periodic data sampling of Figure 29, the IRP 1003 may be configured to sample data in response to receiving an on-demand start command. The on-demand start command may be received by the IRP 1003 from an external device. The on-demand start command may specify a sampling mode, for example, medium resolution sampling (block 1716 of Figure 29) or high resolution sampling (block 1714 of Figure 29), and a period of sampling, which may be in the range of 1 second to 30 seconds. The start command may also specify a sampling rate.

[0154] Intelligent Implant Diagnostics The IRP 1003 of an intelligent implant may be configured to accumulate diagnostic information, such as event count and duration information, that may be used in implant life determination. Exemplary diagnostic information includes the number of controller 1032 reset events that occurred during the implant life, the number of seconds the implant was in a telemetry session during the implant life, the total number of sectors written to flash memory during the implant life, and the total number of sectors erased to flash memory during the implant life. Other exemplary diagnostic information includes the number of seconds the implant was in a low resolution window during the implant life, the number of controller 1032 reset events that occurred during the implant life, the number of seconds the implant was in a medium resolution window during the implant life, and the number of seconds the implant was in a high resolution window during the implant life. Still other exemplary diagnostic information includes recording the number of seconds the implant was in medium resolution mode due to on-demand operation during the current day, recording the number of seconds the implant was in high resolution mode due to on-demand operation during the current day, and recording the battery voltage at the start of the last low resolution window that occurred.

[0155] Clinical use The following disclosure focuses on total or partial shoulder replacement, particularly with replacement of the humerus, but the disclosure applies more generally to any of the medical implants disclosed herein. Currently, post-operative monitoring of shoulder replacement patients during their hospital stay is performed through personal visits by hospital staff and medical teams, physical examination of the patient, medical monitoring (vital signs, etc.), assessment of shoulder range of motion (ROM), physical therapy (including early mobilization and activity), and diagnostic imaging studies and blood work as needed. Once the patient is admitted, denture performance and patient satisfaction are checked during routine physician visits, and a complete history, physical examination, supplemental imaging and diagnostic studies are used to monitor the patient's progress and identify the development of potential complications. During these visits, the surgeon typically assesses the range of shoulder motion, attempts to identify any pain that occurs during specific movements or actions, and questions the patient to determine activity levels, daily function, pain control, and rehabilitation progress.

[0156] Unfortunately, most of a patient's recovery period occurs in the hospital and / or between visits. Thus, it can be very difficult to accurately measure and follow full range of motion from the day of surgery to full recovery (ROM can vary depending on pain control, degree of anti-inflammatory medication, time of day, recent activity, and / or how the patient feels at the time of the examination). For much of this information, physicians rely on patient self-report or third-party observation to gain insight into the effectiveness of post-operative treatment and progress in recovery and rehabilitation. Often, this is further complicated by patients who are unclear about what to look for, do not know if post-operative recovery is normal / expected, are non-compliant, or are unable to effectively communicate symptoms. Additionally, identification and tracking of complications (inpatient and outpatient) before they become symptomatic, occur between physician visits, or are difficult for the patient (and / or physician) to detect also provides additional information that is beneficial to the management of shoulder replacement patients. Currently, in all cases, neither physicians nor patients have access to the type of "real-time," continuous, objective, prosthetic performance measurements that they might otherwise want to have.

[0157] The present disclosure provides novel shoulder joint replacements that overcome many of the difficulties of previous shoulder joints, methods for constructing and monitoring these novel shoulder joint replacements, and further provides other related advantages.

[0158] According to one embodiment, the sensor provides assessment data regarding the range of motion (ROM) of the shoulder. Currently, ROM is typically measured clinically by passively moving the shoulder joint through a full range of motion during a physical exam and recording the results (flexion, extension, abduction, adduction). Using motion sensors and accelerometers, the full ROM of the prosthetic shoulder joint can be accurately determined both during the physical exam and during normal daily activities between clinic visits. Similarly, motion sensors and accelerometers can be used to accurately measure any instability of the prosthetic shoulder joint (including complete, partial, or sub-clinical dislocations) both during the physical exam and during normal daily activities between clinic visits.

[0159] During shoulder replacement surgery, the prosthesis is moved through a full range of motion and stability testing to assess prosthetic function and mobility prior to surgical closure. The accelerometer of the implant of the present disclosure can provide the surgeon with a range of accurate, numerical, quantitative motion data at that time, which can be compared to expected values ​​to assess the effectiveness of the implantation procedure and serve as a baseline value for comparison with functional values ​​obtained postoperatively. Abnormalities of vibration (indicative of insufficient fixation of the prosthesis to the surrounding bone), tilt (indicative of improper tracking and / or alignment of the glenohumeral joint), rotation (indicative of dislocation or subluxation), and / or range of motion (working in conjunction with the vertex band); a properly functioning glenohumeral joint allows a wide range of motion in the upper limb, particularly flexion-extension, abduction, addition, external / lateral rotation, internal / medial rotation, and bypass) can be addressed at this point, allowing the surgeon to make adjustments intraoperatively.

[0160] Immediately after the shoulder joint or a portion thereof (e.g., a prosthetic humerus as disclosed herein) is replaced and after an appropriate post-operative recovery period, the upper arm is mobilized post-operatively, first passively and then actively, and the patient begins incremental movement of the shoulder joint immediately after recovery from the procedure. The accelerometer can measure the movement and tracking of the shoulder joint during movement. In addition, the accelerometer can measure the effect of the arm when the associated hand contacts various objects. As the patient continues to improve his or her range of motion post-operatively, the acceleration experienced at different positions of the prosthetic shoulder joint, e.g., the prosthetic humerus, can be monitored. As the patient heals from surgery, activity levels are expected to increase incrementally, improving and increasing movement and shoulder use. The effects of exercise and various activities can be monitored by various accelerometers and compared to the patient's subjective experience to determine which life activities are improving (or hindering) post-operative recovery and rehabilitation.

[0161] The sensors described herein (e.g., accelerometers and gyroscopes) allow the use of simple commercial analytical technologies, such as pedometers and global positioning satellite (GPS) capabilities, to allow the collection of additional clinically significant data, such as, but not limited to, the patient's activity level (frequency, duration, intensity of activity), exercise tolerance (work, calories, power, training effect), range of motion (discussed elsewhere herein) and denture performance under various "real world" conditions. It is difficult to overstate the value of this information to allow for better management of the patient's recovery. The attending physician (or physical therapist, rehabilitation specialist) observes the patient outside of the body only during scheduled visits; the degree of patient function at the exact time of the examination can be influenced by a number of different factors, such as: presence or absence of pain, presence or absence of inflammation, stiffness, time of day, compliance and timing of medication use (pain medications, anti-inflammatories), recent activity and exercise levels, strength of the patient, mental state, language barriers, the nature of the doctor-patient relationship, and even the ability of the patient to accurately describe their symptoms. Continuous monitoring and data collection allows patients and physicians to objectively monitor progress by providing objective information on patient function under multiple conditions and circumstances, to evaluate how performance is affected by various interventions (pain control, exercise, physical therapy, anti-inflammatory drugs, rest, etc.), and to compare rehabilitation progress with previous and future expected function. Better treatment decisions and better patient compliance can be expected when both physicians and patients have the advantage of observing the effects of various treatment modalities on the patient's rehabilitation, activity, function, and overall performance.

[0162] The disclosed devices, methods, systems, etc. are described broadly and generically herein. Each of the narrower species and subgeneric groupings falling within the generic disclosure also form part of the present disclosure. This includes the generic description of the disclosed devices, methods, systems, etc. with a proviso or negative limitation that removes any subject matter from the genus, regardless of whether the excised material is specifically recited herein.

[0163] As used herein and in the appended claims, unless the context clearly dictates otherwise, the singular forms "a," "an," and "the" include plural references, the term "X and / or Y" means "X" or "Y," or both "X" and "Y," and it should also be understood that the letter "s" denotes both the plural and the singular form of that noun. Furthermore, when features or aspects of the disclosure are described in terms of a Markush group, the disclosure is intended to encompass and be described by any individual members and any subgroups of members of the Markush group, as one of ordinary skill in the art will recognize. Applicants reserve the right to amend this application or claims to specifically refer to any individual members or any subgroups of members.

[0164] It is to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting. It is to be further understood that, unless specifically defined herein, terms used herein are to be given their conventional meaning as known in the relevant art.

[0165] Throughout this specification, references to "one embodiment" or "one embodiment" and variations thereof mean that a particular feature, structure, or characteristic described in connection with an embodiment is included in at least one embodiment. Thus, the appearances of the phrases in various places throughout this specification do not necessarily all refer to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0166] As used herein and in the appended claims, the singular includes plural references, i.e., one or more, unless the content and context clearly dictate otherwise. For example, the term sensor refers to one or more sensors, and the term medical device comprising a sensor refers to a medical device including at least one sensor. A plurality of sensors refers to two or more sensors. It should also be noted that the conjunctions "and" and "or" are generally used in their broadest sense to include "and / or," unless the content and context clearly dictates inclusiveness or exclusivity, as the case may be. Thus, the use of the alternative (e.g., "or") should be understood to mean either one, both, or any combination thereof of the alternatives. In addition, when described herein as "and / or," the "and" and "or" compositions are intended to encompass embodiments including all of the associated items or ideas, as well as one or more other alternative embodiments that include less than all of the associated items or ideas.

[0167] Unless the context otherwise requires, throughout the following specification and claims, the terms "comprising" and synonyms and variations thereof, such as "acting" and "comprising," as well as "comprising" and "comprising" are to be interpreted in an open and inclusive sense, e.g., "including, but not limited to." The term "consisting essentially of" limits the claim to particular materials or steps, or to materials or steps that do not materially affect the basic and novel characteristics of the claimed invention.

[0168] The headings used within this document are merely utilized to facilitate the reader's review thereof and should not be construed as limiting the scope of the disclosure, the invention, or the claims in any manner. Thus, the headings and abstracts of the disclosure provided herein are merely for convenience and do not interpret the scope or meaning of the embodiments.

[0169] Where a range of values ​​is provided herein, unless the context clearly dictates otherwise, it is understood that each intervening value, to the tenth of the unit of the lower limit between the upper and lower limits of that range, and any other stated or intervening value within that stated range, is encompassed within the scope of the disclosure, invention, or claims. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges, and are also encompassed within the disclosure, subject to any specifically excluded limits in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the disclosure.

[0170] For example, any concentration range, percentage range, ratio range, or integer range provided herein should be understood to include any integer value within the recited range, and fractions thereof (such as tenths and hundredths of integers), where appropriate, unless otherwise indicated. Also, any numerical range recited herein relating to any physical characteristic, such as polymer subunits, size, or thickness, should be understood to include any integer within the recited range, unless otherwise indicated. As used herein, the term "approximately" means ±20% of the indicated range, value, or structure, unless otherwise indicated.

[0171] All U.S. patents, U.S. patent application publications, U.S. patent applications, foreign patents, foreign patent applications, and non-patent publications mentioned herein and / or listed in the Application Data Sheet are incorporated herein by reference in their entirety. Such documents may be incorporated by reference, for example, for the purpose of describing and disclosing the materials and methodologies described in the publications that may be used in connection with the present disclosure. The publications discussed above and throughout the text are provided solely for their disclosure prior to the filing date of this application. Nothing herein should be construed as an admission that the inventors are not entitled to antedate any publications referenced by prior invention.

[0172] All patents, publications, scientific articles, websites, and other documents and materials referenced or mentioned in this specification are indicative of the level of skill of those skilled in the art to which this disclosure pertains, and each such referenced document and material is incorporated by reference herein to the same extent as if it were individually incorporated by reference in its entirety or set forth by reference in its entirety herein. Applicant reserves the right to physically incorporate into this specification any and all materials and information from such patents, publications, scientific articles, websites, electronically available information, and other reference materials or documents.

[0173] In general, in the following claims, the terms used should not be construed to limit the claims to the specific embodiments disclosed in the specification and the claims, but should be construed to include all possible embodiments, along with the full scope of equivalents to which such claims are entitled. Accordingly, the claims are not limited by this disclosure.

[0174] Further, the written description portion of this patent includes all claims. Moreover, all claims, including all original claims and all claims from any and all priority documents, are incorporated by reference in their entirety into the written description portion of this specification. Applicant reserves the right to physically incorporate any and all scope of such claims into the written description or any other portion of this application. Thus, for example, under no circumstances will a patent be construed as failing to provide a written description of a claim with respect to an assertion that the exact wording of the claim is not recited in Heckon in the written description portion of the patent.

[0175] The claims are interpreted according to law. However, regardless of any assertion or recognition of ease or difficulty in interpreting the claims or any part thereof, any adjustment or modification of the claims or any part thereof during the filing of this application leading to this patent may be construed as prejudicing any right to any and all equivalents thereof that do not form part of the prior art.

[0176] Other non-limiting embodiments are within the scope of the following claims. A patent may not be construed as limited to the particular examples or non-limiting embodiments or methods specifically and / or expressly disclosed herein. Under no circumstances may a patent be construed as limited by an oath made by an examiner or other officer or employee of the Patent and Trademark Office, unless such an oath is subject to a qualification or reservation expressly adopted in a responsive writing by the applicant.

[0177] As noted above, in the following claims, the terms used should not be construed to limit the claims to the specific embodiments disclosed in the specification and the claims, but should be construed to include all possible embodiments, along with the full scope of equivalents to which such claims are entitled. For example, an illustrated embodiment having one or more omitted components or steps may be an additional embodiment contemplated and covered by the present application.

Claims

1. An intelligent implant, comprising: a component of a transplantable prosthesis; and a transplantable reporting processor, wherein the reporting processor is associated with the component; a housing having a casing and a cover coupled to the casing; an electronic assembly within the housing; and an antenna within the housing and coupled to the electronic assembly, the antenna being configured within a loop and comprising a flat ribbon having a main surface, the antenna being oriented within the cover of the housing with the main surface of the antenna generally parallel to the inner surface of the cover.

2. The antenna of claim 1, further comprising: a curved end; a flat end opposite the curved end; and opposing side surfaces extending between the curved end and the flat end.

3. The intelligent implant of claim 2, wherein the cover comprises a dome-shaped closed end, and the curved end of the antenna is within the dome-shaped closed end.

4. The intelligent implant of claim 2, wherein the cover comprises a side wall extending from the dome-shaped closed end, and the opposing side surfaces of the antenna are surrounded by the side wall.

5. The intelligent implant of claim 2, wherein the flat end of the antenna is electrically coupled to the electronic assembly.

6. The flat end of the antenna comprises a first portion separated from a second portion by a gap, the first portion including a first notch at an edge configured to couple to a first feed-through pin of the electronic assembly, and the second portion including a second notch at an edge configured to couple to a second feed-through pin of the electronic assembly.

7. The antenna of claim 1, further comprising: platinum (Pt) having an atomic percentage in the range of 70% to 100%; and iridium (Ir) having an atomic percentage in the range of 0% to 30%.

8. The intelligent implant of claim 7, wherein the material is Pt90Ir10.

9. The intelligent implant according to claim 1, wherein the main surface of the antenna has a surface finish in the range of 0 microinches to a maximum of 15 microinches.

10. The intelligent implant according to claim 9, wherein the surface finish is a maximum of 6 microinches.

11. The intelligent implant according to claim 1, wherein the implantable reporting processor further includes an epoxy material encapsulating the antenna.

12. The intelligent implant according to claim 1, wherein the implantable prosthesis is a tibial component of a knee prosthesis, and the implantable reporting processor is mechanically coupled to a tibial stem of the tibial component.

13. The intelligent implant according to claim 12, wherein the tibial component includes a tibial plate configured to fix to the tibia in the absence of cement, and the tibial stem extends from the tibial plate.

14. The intelligent implant according to claim 1, wherein the implantable prosthesis is a humeral component of a shoulder prosthesis, and the implantable reporting processor is mechanically coupled to the humeral component.

15. The intelligent implant according to claim 1, wherein the implantable prosthesis is a femoral component of a hip joint prosthesis, and the implantable reporting processor is mechanically coupled to the femoral component.

16. A stem tibial component of a knee prosthesis, wherein the tibial component comprises a tibial stem and a tibial extension mechanically coupled to the tibial stem and partially extending from the tibial stem, the tibial stem extension comprises a housing having a casing and a cover coupled to the casing, electronic assemblies within the housing, and an antenna within the housing and coupled to the electronic assemblies, the antenna comprising a flat ribbon configured in a loop and having a main surface, the antenna being oriented within the cover of the housing such that the main surface of the antenna is generally parallel to the inner surface of the cover.

17. A tibial component of a knee prosthesis, wherein the tibial component comprises a tibial stem having a receptacle and A transplantable reporting processor that is partially within the receptacle and extends partially from the tibial stem, and, the transplantable reporting processor being, a battery within the receptacle, an electronic assembly coupled to the battery and within the receptacle, an antenna coupled to the electronic assembly and outside the receptacle, the antenna comprising a flat ribbon configured in a loop and having a major surface, a cover outside the receptacle and enclosing the antenna, the antenna being oriented within the cover with the major surface of the antenna generally parallel to the inner surface of the cover, a tibial component. **Claim 18** The tibial component according to claim 17, wherein the transplantable reporting processor further comprises an antenna feedthrough assembly coupled between the electronic assembly and the antenna and at least partially within the receptacle.

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