Implantable medical devices with sensing and communication capabilities using substrate antennas

Abstract

An implantable system for a patient's body part may include an electronic circuit. The electronic circuit may include at least one sensor, a processor configured to receive data acquired by the at least one sensor, a communication circuit connected to the processor and configured to transmit data acquired by the at least one sensor, and an antenna including a plurality of conductive traces present on a biocompatible substrate, the antenna connected to the communication circuit and further configured to facilitate the transmission of the data. The body part may be a joint, such as a hip joint or a spine.

Description

[Technical field]

[0001] The present disclosure relates generally to intelligent implants, and more specifically to implantable medical devices having an implantable reporting processor that samples, records, and transmits information related to the placement and integrity of the implanted device, as well as the health of the patient in whom the device is implanted.

[0002] (CROSS REFERENCE TO RELATED APPLICATIONS) All applications filed with this application for which a claim of foreign or domestic priority is identified in the Application Data Sheet are hereby incorporated by reference. [Background technology]

[0003] After treating an internal injury or other internal defect, it can be difficult to monitor the progress of a patient's recovery. For example, after a knee arthroplasty (such as a total knee arthroplasty (TKA)), hip replacement, or shoulder replacement is performed and the patient begins to move with the implant, problems may arise and sometimes be difficult to identify. Clinical examinations are often limited in their ability to detect prosthetic 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 prosthesis, patients are encouraged to see a physician periodically (such as annually) to check their health, monitor other joints, and evaluate the function of the implant. Such evaluations are subjective and often lack the time resolution to delineate small changes in function that may be precursors to larger mobility problems. Long-term (>1 year) follow-up of 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.

[0004] Currently, there is no mechanism to reliably detect implant misplacement, instability, or dislocation without a clinical visit and the hands and visual observations of an experienced medical professional. Yet early identification of sub-clinical problems or conditions is either difficult or impossible, as 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 movement and / or degree of improper alignment cannot be precisely measured or quantified, making targeted and successful intervention unlikely. Existing external monitoring devices do not provide the fidelity required to detect instability, as these devices are separated from the implant 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 implant.

[0005] In general, correct placement of a medical implant can be difficult for a surgeon, and various complications can arise during the insertion of any medical implant (whether in an open surgical procedure or a minimally invasive procedure). For example, a surgeon may want to ensure the correct anatomical alignment and placement of the implant within the surrounding tissues and structures. However, this can be difficult to do during the procedure itself, making intraoperative corrective adjustments difficult.

[0006] Furthermore, patients may experience several complications after 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 in many cases early identification of complications and side effects, while desirable, is difficult or impossible.

[0007] The present disclosure is directed to providing methods and apparatus for identifying, locating and / or quantifying these problems, particularly at an early stage, and correcting these problems.

[0008] All of the subject matter discussed in the Background section is not necessarily prior art, and should not be assumed to be prior art merely as a result of its discussion in the Background section. Along these lines, an awareness of a prior art problem discussed in the Background section or related to such subject matter should not be treated as prior art unless expressly stated to be prior art. Instead, the discussion of any subject matter in the Background section should be treated as part of the inventor's approach to a particular problem, which may itself be inventive. Summary of the Invention

[0009] 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.

[0010] Certain aspects of the present disclosure are directed to an implantable system for a body part of a patient. The system may include an electronic circuit having at least one sensor, a processor configured to receive data acquired by the at least one sensor, and a communication circuit connected to the processor and configured to transmit data acquired by the at least one sensor. The system may include an antenna including a plurality of conductive traces positioned (printed, painted, or otherwise deposited) on a substrate, which may be biocompatible. The antenna may be connected to the communication circuit to facilitate the transmission of the data.

[0011] 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]

[0012] [Figure 1] 1 illustrates an exemplary hip implant according to certain aspects of the present disclosure. [Diagram 2] 1 illustrates an exemplary sensor environment in accordance with certain aspects of the present disclosure. [Diagram 3] 1 illustrates an exemplary sensor system for a hip implant, according to certain aspects of the present disclosure. [Figure 4] 1 illustrates a flow chart of a design process or an antenna for use in a sensor system, according to certain aspects of the present disclosure. [Figure 5A] 1 illustrates a loop antenna, a substrate antenna, and a helix antenna according to certain aspects of the present disclosure. [Figure 5B] 1 illustrates a loop antenna, a substrate antenna, and a helix antenna according to certain aspects of the present disclosure. [Figure 5C] 1 illustrates a loop antenna, a substrate antenna, and a helix antenna according to certain aspects of the present disclosure. [Figure 6] 1 illustrates a cross-sectional view of a sensor assembly having a loop antenna according to certain aspects of the present disclosure. [Figure 7A] 1 illustrates the gain, impedance, and return loss of a loop antenna in accordance with certain aspects of the present disclosure. [Figure 7B]1 illustrates the gain, impedance, and return loss of a loop antenna in accordance with certain aspects of the present disclosure. [Figure 7C] 1 illustrates the gain, impedance, and return loss of a loop antenna in accordance with certain aspects of the present disclosure. [Figure 7D] 1 illustrates the gain, impedance, and return loss of a loop antenna in accordance with certain aspects of the present disclosure. [Figure 8] 1 illustrates a planar inverted-F antenna according to certain embodiments of the present disclosure. [Figure 9A] 1 illustrates the gain, impedance, return loss, and matching network of a planar inverted-F antenna in accordance with certain embodiments of the present disclosure. [Figure 9B] 1 illustrates the gain, impedance, return loss, and matching network of a planar inverted-F antenna in accordance with certain embodiments of the present disclosure. [Figure 9C] 1 illustrates the gain, impedance, return loss, and matching network of a planar inverted-F antenna in accordance with certain embodiments of the present disclosure. [Figure 9D] 1 illustrates the gain, impedance, return loss, and matching network of a planar inverted-F antenna in accordance with certain embodiments of the present disclosure. [Figure 9E] 1 illustrates the gain, impedance, return loss, and matching network of a planar inverted-F antenna in accordance with certain embodiments of the present disclosure. [Figure 9F] 1 illustrates the gain, impedance, return loss, and matching network of a planar inverted-F antenna in accordance with certain embodiments of the present disclosure. [Figure 9G] 1 illustrates the gain, impedance, return loss, and matching network of a planar inverted-F antenna in accordance with certain embodiments of the present disclosure. [Figure 10] 1 illustrates a substrate antenna according to certain aspects of the present disclosure. [Figure 11A] 4 illustrates impedance and return loss of a layer substrate antenna in accordance with certain aspects of the present disclosure. [Figure 11B] 4 illustrates impedance and return loss of a layer substrate antenna in accordance with certain aspects of the present disclosure. [Figure 12]1 illustrates variation in stub length for a substrate antenna in accordance with certain aspects of the present disclosure. [Figure 13] 1 illustrates variation in spacer thickness for a single layer substrate antenna, in accordance with certain aspects of the present disclosure. [Figure 14] 1 illustrates a multi-layer substrate antenna in accordance with certain aspects of the present disclosure. [Figure 15] 1 illustrates grounding of an antenna according to certain aspects of the present disclosure. [Figure 16] 1 illustrates various substrate antenna designs in accordance with certain aspects of the present disclosure. [Figure 17] 1 illustrates a comparison of the performance of various antennas in accordance with certain aspects of the present disclosure. [Figure 18] 1 illustrates a zigzag pattern for a substrate antenna, according to certain aspects of the present disclosure. [Figure 19A] 1 illustrates an implantable medical device having sensing and communication capabilities in accordance with certain aspects of the present disclosure. [Figure 19B] 1 illustrates an implantable medical device having sensing and communication capabilities in accordance with certain aspects of the present disclosure. [Figure 20A] 4 illustrates a matching network and return loss of a substrate antenna in accordance with certain aspects of the present disclosure. [Figure 20B] 4 illustrates a matching network and return loss of a substrate antenna in accordance with certain aspects of the present disclosure. [Figure 20C] 4 illustrates a matching network and return loss of a substrate antenna in accordance with certain aspects of the present disclosure. [Figure 21A] 1 illustrates comparative performance of various antenna and substrate antenna implementations in accordance with certain aspects of the present disclosure. [Figure 21B] 1 illustrates comparative performance of various antenna and substrate antenna implementations in accordance with certain aspects of the present disclosure. [Figure 21C] 1 illustrates comparative performance of various antenna and substrate antenna implementations in accordance with certain aspects of the present disclosure. [Figure 21D] 1 illustrates comparative performance of various antenna and substrate antenna implementations in accordance with certain aspects of the present disclosure. [Figure 21E]1 illustrates comparative performance of various antenna and substrate antenna implementations in accordance with certain aspects of the present disclosure. [Figure 22A] 1 illustrates a substrate antenna having a cover, according to certain aspects of the present disclosure. [Figure 22B] 1 illustrates a substrate antenna having a cover, according to certain aspects of the present disclosure. [Figure 23A] 1 illustrates various antenna covers according to certain aspects of the present disclosure. [Figure 23B] 1 illustrates various antenna covers according to certain aspects of the present disclosure. [Figure 23C] 1 illustrates various antenna covers according to certain aspects of the present disclosure. [Figure 24A] 1 illustrates the return loss of a substrate antenna with a cover, according to certain aspects of the present disclosure. [Figure 24B] 1 illustrates the return loss of a substrate antenna with a cover, according to certain aspects of the present disclosure. [Figure 25A] 1 illustrates the communication range of various substrate antennas, according to certain aspects of the present disclosure. [Figure 25B] 1 illustrates the communication range of various substrate antennas, according to certain aspects of the present disclosure. [Figure 25C] 1 illustrates the communication range of various substrate antennas, according to certain aspects of the present disclosure. [Figure 25D] 1 illustrates the communication range of various substrate antennas, according to certain aspects of the present disclosure. [Figure 25E] 1 illustrates the communication range of various substrate antennas, according to certain aspects of the present disclosure. [Figure 26A] 1 illustrates a sensor assembly in the form of a spinal cage having an insertable cartridge, the cartridge including an implantable reporting processor. [Figure 26B] FIG. 26B shows a perspective view of the insertable cartridge of FIG. 26A. [Figure 26C] FIG. 26B shows a perspective view of the insertable cartridge of FIG. 26A. [Figure 27A] 1 illustrates another sensor assembly in the form of a spinal cage having an insertable cartridge, the cartridge including an implantable reporting processor. [Figure 27B] 27B shows a cross-sectional view of the insertable cartridge of FIG. 27A. [Figure 27C] 27B shows a cross-sectional view of the insertable cartridge of FIG. 27A. [Figure 27D] 27B shows a cross-sectional view of the insertable cartridge of FIG. 27A. [Figure 28] 1 illustrates a sensor assembly in the form of a spine cage having an insertable cartridge, the spine cage including a window. [Figure 29A] FIG. 23B shows a cross-sectional medial-side view of the sensor assembly of FIG. 23A. [Figure 29B] FIG. 24B shows a cross-sectional medial-side view of the sensor assembly of FIG. 24A. [Figure 30A] FIG. 1 illustrates a front posterior-anterior view of a sensor assembly having a spinal cage with an insertable cartridge, the spinal cage not including a window. [Figure 30B] FIG. 1 illustrates a front posterior-anterior view of a sensor assembly having a spinal cage with an insertable cartridge, the spinal cage including a window. [Diagram 31] 26A-26C, 27A-27D, 28, 29A-29B, or 30A-30B implanted into a patient's spine during spinal fusion. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0013] The present disclosure may be more readily understood by reference to the following detailed description of exemplary configurations of an "intelligent implant", "sensor assembly", or "sensor system" contained herein. The following description, in conjunction 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, and the like. In other examples, well-known structures or components relevant to the environment of the present disclosure, including but not limited to communication systems and networks, have not been shown or described to avoid unnecessarily obscuring the description of the embodiments. Furthermore, the various embodiments may be methods, systems, media, or devices. Thus, the various embodiments may be entirely hardware embodiments, entirely software embodiments, entirely firmware embodiments, or embodiments that combine or sub-combine software, firmware, and hardware aspects.

[0014] Before describing the present disclosure in more detail, an understanding thereof may be useful to provide definitions of certain terms used herein. Additional definitions are described throughout the present disclosure. The terms "comprise" and "comprising" and their derivatives mean inclusion, without limitation. The term "or" is inclusive, semantic, and / or. The terms "associated" and "associated" and their derivatives may mean including, contained within, interconnected, containing, included within, connected to, or coupled with, or in communication with, cooperating with, interleaving, juxtaposing, adjacent to, or coupled with, having, having a characteristic of, or the like. The terms "controller" or "processor" refer to any device, system, or part thereof that controls at least one operation, and such devices may be implemented in hardware (e.g., electronic circuitry), firmware, or software, or any combination of at least two of them. The functionality associated with any particular controller may be local or remote, centralized or distributed. Other definitions of particular words and phrases may be provided within this patent document, and those of ordinary skill in the art will understand that in many cases, if not most, such definitions apply to prior and future uses of such defined words and phrases.

[0015] As used in this disclosure, an "intelligent medical device" is an implantable or implanted medical device that preferably replaces or functionally complements a natural body part of a subject. The intelligent medical device may include one of the disclosed sensor assemblies and / or anchor (or anchor) structures. The sensor assembly comprises or is associated with a controller or processor, also referred to as an implantable reporting processor (IRP). In one configuration, the intelligent medical device is an implantable or implantable medical device having a sensor assembly with an IRP arranged to perform the functions described herein. The sensor assembly may perform one or more of the following example actions to characterize the post-implantation status of the intelligent medical device: A method comprising: identifying the intelligent medical device or portion of the intelligent medical device (e.g., by recognizing a sensor assembly or one or more unique identification codes for the intelligent medical device or portion of the intelligent medical device); detecting, sensing, and / or measuring parameters, which may collectively be referred to as monitoring parameters, to collect operational, physiological, kinematic, or other data, which may optionally be collected as a function of time, about the intelligent medical device or portion of the intelligent prosthetic device (e.g., the sensor assembly); storing the collected data within the intelligent medical device or portion of the intelligent medical device (e.g., the sensor assembly); and wirelessly communicating the collected and / or stored data from the intelligent medical device or portion of the intelligent medical device (e.g., the sensor assembly) to an external computing device, which 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.A non-limiting and non-exhaustive list of configurations of an intelligent medical device includes a housing configured to be implanted in a body part.

[0016] As used herein, monitoring data includes some or all of the data, individually or collectively, associated with a particular implantable sensor assembly and available for communication outside of a particular implantable sensor system. For example, monitoring data may include raw data from one or more sensors of a sensor assembly. Monitoring 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 sensor assembly. In some cases, high resolution monitoring data includes monitoring data from one, many, or all of the sensors of a sensor assembly that is collected in greater volume, resolution, from more sensors, more frequently, or the like.

[0017] 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 (e.g., anatomy, physiology, metabolism, and / or function) and / or one or more aspects of a smart medical device or sensor system. 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 in a quantitative manner, one or more different aspects of a body tissue (anatomy, physiology, metabolism, and / or function), and / or one or more aspects of an implant. 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 implant (e.g., patient alignment).

[0018] A sensor assembly may refer to one or more components. For example, a sensor assembly may be a single component sensor with on-sensor processing and wireless transmission. In other examples, a sensor assembly may be a multi-component assembly having a sensor and other components to perform one or more functions described herein.

[0019] To further understand the various aspects of the inventions provided herein, the following sections are provided below: I. Overview, II. Sensor Assembly, III. Additional Embodiments and Terminology, and VI. Exemplary Embodiments.

[0020] I. Overview The present disclosure provides an intelligent implant (or sensor system or sensor assembly), e.g., an implantable medical device having an implantable reporting processor (IRP), that can be utilized to monitor and report the status and / or activity of the implant itself, as well as the status and / or activity of a patient in whom the intelligent implant is implanted. The intelligent implant can be implanted in any joint of a patient's body part. For example, in one embodiment, the intelligent implant is part of an implant system that replaces a patient's joint, e.g., knee, shoulder, or hip, and allows the patient to have the same or nearly the same mobility provided by a healthy joint. 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. Examples of joint replacement implant systems into which the intelligent implants disclosed herein may be incorporated are described in PCT Publication Nos. WO 2014 / 144107, WO 2014 / 209916, WO 2016 / 044651, WO 2017 / 165717, and WO 2020 / 247890, the disclosures of which are incorporated herein in their entireties.

[0021] In one embodiment, the implantable medical device is a hip implant system or a component of a hip implant system, in particular a total hip implant for a total hip arthroplasty (or total hip replacement). An intelligent implant included in the overall hip implant system can monitor and characterize the motion of the hip implant. 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), macroinstability, and microinstability. For more details on these types of motion, see PCT Publication Nos. WO 2017 / 165717 and WO 2020 / 247890.

[0022] FIG. 1 illustrates a femoral implant 120 (or femoral prosthesis or hip joint implant) for a total hip replacement. The femoral implant 120 can be a cemented implant (which can be fixed in place with bone cement) or a cementless implant. The hip joint is a ball and socket joint. The socket is formed by the acetabulum, which is part of the pelvis 134. The ball is the femoral head, which is the top end of the femur 132. The femoral implant 120 can include a femoral stem 122 and a femoral head 124. During a total hip replacement, a damaged femoral head can be removed and replaced with the femoral stem 122, which is placed within the femur 132. A ball-shaped component (femoral head 124) can be placed on top of the femoral stem 122. This component replaces the damaged femoral head that was removed.

[0023] In some cases, the implantable medical device is a knee implant system or a component of a knee implant system, particularly a total knee implant for total knee arthroscopy. An intelligent implant included in the overall knee implant system can monitor and characterize the motion of the knee implant. In some instances, the implantable medical device can be a shoulder implant, an elbow implant, or an implant for another joint or body part. More generally, the implantable medical device can be any implantable device.

[0024] 2 illustrates an exemplary sensor environment 10. In the environment 10, one or more sensor assemblies 100a, 100b may be implanted by a medical professional 2 into the body of a patient 1. The sensor assemblies 100a, 100b may include an associated implantable reporting processor (IPR) that may be arranged and configured to collect data including, for example, medical and health data related to the patient 1 with which the sensor assemblies 100a, 100b are associated, as well as operational data of the sensor assemblies 100a, 100b themselves. The sensor assemblies 100a, 100b may communicate with one or more base stations 4 or one or more computing devices 3 during different stages of monitoring the patient 1. While implanted in the patient's body 1, the sensor assemblies 100a, 100b may also communicate with a barcode scanner 5 such that the barcode scanner 5 can identify the particular sensor assembly 100a, 100b implanted in the patient 1. The barcode scanner 5 and / or the base station 4 may communicate with one or more computing devices 3.

[0025] For example, in connection with a medical procedure, the sensor assemblies 100a, 100b may be implanted in the patient's body 1. The sensor assemblies 100a, 100b may communicate with an operating room base station 4. While the patient 1 is at home and after sufficient recovery from the medical procedure, the sensor assemblies 100a, 100b may be arranged to communicate with a home base station (not shown) and / or a clinic base station (not shown). The sensor assemblies 100a, 100b may communicate with each base station via a short-range network protocol such as Medical Implant Communication Service (MICS), Medical Device Radio Communication Service (MedRadio), Industrial, Scientific and Medical (ISM), Bluetooth, or any other wireless communication protocol suitable for use with the sensor assemblies 100a, 100b. The MICS band may have a frequency range (or bandwidth) of approximately 402 MHz to 405 MHz, with a center frequency of approximately 403.5 MHz. The ISM band may have a bandwidth of approximately 2.4 GHz to 2.5 GHz, with a center frequency of approximately 2.45 GHz. This frequency band may at least partially overlap with the Bluetooth frequency band.

[0026] The sensor assemblies 100a, 100b may be standalone medical devices or, desirably, may be components of a larger system that includes an anchor structure capable of collecting and providing patient medical data, device operational data, or other useful data.

[0027] The sensor assemblies 100a, 100b may include one or more measurement units, e.g., sensors, capable of collecting information and data, including medical and health data related to the patient 1 with which the sensor assemblies 100a, 100b are associated, as well as operational data for the assemblies 100a, 100b themselves.

[0028] The sensor assemblies 100a, 100b can collect data at a variety of different times and at a variety of different rates during the process of monitoring the patient 1. In some configurations, the sensor assemblies 100a, 100b can operate at multiple different stages throughout the process of monitoring the patient. For example, the sensor assemblies 100a, 100b can collect more data immediately after the sensor assemblies 100a, 100b are implanted in the patient 1, can collect less data as the patient 1 heals, and so forth.

[0029] The amount and type of data collected by the sensor assemblies 100a, 100b may vary from patient to patient, and the amount and type of data collected may vary for a single patient. For example, a medical professional studying the data collected by the sensor assemblies 100a, 100b for a particular patient may adjust or otherwise control how the sensor assemblies 100a, 100b collect future data.

[0030] The amount and type of data collected by the sensor assemblies 100a, 100b may be different for different body parts, different types of patient conditions, different patient demographic characteristics, or other differences. Alternatively, or additionally, the amount and type of data collected may change over time based on other factors such as how the patient is healing or feeling, how long the monitoring process will last, how much battery power is left and should be conserved, the type of movement being monitored, the body part being monitored, etc. In some cases, the collected data may be supplemented with personal descriptive information provided by the patient, such as subjective pain data, quality of life indicator data, comorbidities, perceptions, or expectations that the patient associates with the sensor assemblies 100a, 100b, etc.

[0031] The implantation of the sensor assembly 100a, 100b into the patient 1 may occur in an operating room. As used herein, an operating room includes any office, room, building, or facility in which the sensor assembly 100a, 100b may be implanted into a patient. For example, an operating room may be a typical operating room in a hospital, an operating room in a surgical clinic or doctor's office, or any other operating room, intervention room, intensive care unit, emergency room, etc., in which the sensor assembly 100a, 100b is implanted into a patient.

[0032] The procedure room base station 4 may be utilized to configure and initialize the sensor assemblies 100a, 100b when the sensor assemblies 100a, 100b are implanted in the patient 1. A communication relationship may be formed between the sensor assemblies 100a, 100b and the procedure room base station 4, for example, based on polling signals transmitted by the procedure room base station 4 and response signals transmitted by the sensor assemblies 100a, 100b.

[0033] Upon establishing a communication relationship, which may often occur prior to implantation of the sensor assemblies 100a, 100b, the operating room base station 4 may transmit initial configuration information to the sensor assemblies 100a, 100b. The initial configuration information may include, but is not limited to, a time stamp, a date stamp, an identification of the type and placement of the sensor assemblies 100a, 100b, information about other implants associated with the sensor assemblies 100a, 100b, surgeon information, patient identification, operating room information, etc.

[0034] In some configurations, the initial configuration information may be passed unidirectionally. In some embodiments, the initial configuration information may be passed bidirectionally. The initial configuration information may define at least one parameter associated with the collection of data by the sensor assemblies 100a, 100b. For example, the initial configuration information may identify settings for one or more sensors of the sensor assemblies 100a, 100b for each of one or more operating modes. The initial configuration information may also include an initial operating mode of the sensor assemblies 100a, 100b, specific events that trigger a change in operating mode, wireless settings, data collection information (e.g., how often the sensor assemblies 100a, 100b wake up to collect data, when to collect data, how much data to collect), home base station (not shown), computing device 3, and connected personal assistant identification information, as well as other control information related to the implantation or operation of the sensor assemblies 100a, 100b. Examples of connected personal assistants, which may also be called smart speakers, include Neak Echo®, Neak Dot®, Google Home®, Neak® patient monitors, Comcast health tracking speakers, and Apple Home Pods®.

[0035] In some configurations, the initial configuration information may be pre-stored on the operating room base station 4 or associated computing device 3. In other configurations, a surgeon, surgical technician, or some other medical personnel 2 may input control information and other parameters into the operating room base station 4 for transmission to the sensor assemblies 100a, 100b. In at least one such configuration, the operating room base station 4 may communicate with the operating room configuration computing device 3. The operating room configuration computing device 3 may include an application having a graphical user interface that allows a physician to input configuration information for the sensor assemblies 100a, 100b. In various configurations, the application running on the operating room configuration computing device 3 may have portions of pre-defined configuration information that may or may not be adjustable by the medical personnel 2. The operating room configuration computing device 3 may communicate the configuration information to the operating room base station 4, which may communicate to the sensor assemblies 100a, 100b, via a wired or wireless network connection (e.g., a USB connection, a Bluetooth connection, a Bluetooth Low Energy (BTLE) connection, or a Wi-Fi connection).

[0036] The procedure room configuration computing device 3 may also display information regarding the sensor assemblies 100a, 100b or the procedure room base station 4 to the surgeon, surgical technician, or other medical personnel 2. For example, the procedure room configuration computing device 3 may display error information if the sensor assemblies 100a, 100b are unable to store or access configuration information, if the sensor assemblies 100a, 100b are unresponsive, if the sensor assemblies 100a, 100b identify a problem with one of the sensors or radios during an initial self-test, if the procedure room base station 4 is unresponsive or malfunctioning, or for other reasons.

[0037] Although the procedure room base station 4 and the procedure room configuration computing device 3 are described as separate devices, embodiments are not so limited, and rather, as shown, the functionality of the procedure room configuration computing device 3 and the procedure room base station 4 may be included within a single computing device or within separate devices. In this manner, medical personnel 1 may be able to input configuration information directly into the procedure room base station 4, in one embodiment.

[0038] Returning to FIG. 1, once the sensor assemblies 100a, 100b are implanted into the patient and the patient returns home, the home base station, the computing or smart device (e.g., the patient's smartphone), the connected personal assistant, or two or more of the home base station and the computing or smart device, and the connected personal assistant can communicate with the sensor assemblies 100a, 100b. The sensor assemblies 100a, 100b can collect data at a determined rate and time, a variable rate and time, or an otherwise controllable rate and time. Data collection can begin when the sensor assemblies 100a, 100b are initialized in the operating room, when instructed by the medical personnel 1, or at some later time. At least some of the data collected by the sensor assemblies 100a, 100b may be transmitted directly to the home base station, to the smart device, to the directly connected personal assistant, to the base station via one or both of the smart device and the connected personal assistant, to the smart device via one or both of the base station and the connected personal assistant, or to the connected personal assistant via one or both of the smart device and the base station. Here, either or both means via the items only, and via both items serially or in parallel. For example, data collected by the sensor assemblies 100a, 100b may be transmitted to the home base station via the smart device only, via the connected personal assistant only, serially via the smart device and the connected personal assistant, serially via the connected personal assistant and the smart device, and directly via both the smart device and the connected personal assistant, and possibly simultaneously.Similarly, data collected by the sensor assemblies 100a, 100b may be transmitted to the smart device only via the home base station, only via the connected personal assistant, serially via the home base station and the connected personal assistant, serially via the connected personal assistant and the home base station, or even via both the home base station and the connected personal assistant. Additionally, in embodiments, data collected by the sensor assemblies 100a, 100b may be transmitted to the connected personal assistant only via the smart device, only via the home base station, serially via the smart device and the home base station, serially via the home base station and the smart device, and possibly simultaneously via both the smart device and the home base station.

[0039] In various configurations, one or more of the home base station, the smart device, and the connected personal assistant can ping the sensor assembly 100a, 100b periodically, at predetermined, or other times to determine whether the sensor assembly 100a, 100b is within communication range with one or more of the home base station, the smart device, and the connected personal assistant. Based on a response from the sensor assembly 100a, 100b, the home base station, the smart device, and the connected personal assistant can determine that the sensor assembly 100a, 100b is within communication range and can request, command, or otherwise instruct the sensor assembly 100a, 100b to transmit collected data to one or more of the home base station, the smart device, and the connected personal assistant.

[0040] Each of the home base station, the smart device, and one or more of the connected personal assistants may be configured with a respective optional user interface in some cases. The user interface may be formed as a multimedia interface, passing one or more types of multimedia information (e.g., video, audio, tactile, etc.) in one or two directions. Through the respective user interfaces of the home base station, the smart device, and one or more of the connected personal assistants, the patient 1 or an association of the patient 1 may input other data to supplement the data collected by the sensor assemblies 100a, 100b. The user may, for example, input personally descriptive information (e.g., age change, weight change), changes in medical condition, co-morbidities, pain levels, quality of life or other subjective indicator data, personal messages for medical personnel, etc. In these configurations, the personal descriptive information may be input with a keyboard, mouse, touch screen, microphone, wired or wireless computing interface, or any other input means. If personal descriptive information is collected, the personal descriptive information may include or be otherwise associated with one or more identifiers that associate the information with a unique identifier of the sensor assembly 100a, 100b, the patient, an associated medical professional, an associated medical facility, etc.

[0041] In some of these cases, an optional user interface of one or more of the home base station, smart device, and connected personal device may also be arranged to deliver information associated with the sensor assembly 100a, 100b to a user, for example from a medical practitioner 2. In these cases, the information delivered to the user may be delivered via a video screen, an audio output device, a tactile transducer, a wired or wireless computing interface, or some other similar means.

[0042] In configurations where one or more of the home base station, smart device, and connected personal assistant are disposed with a user interface, the user interface may be formed with an internal user interface disposed for communicative coupling to a patient portal device. The patented portal device may be a smartphone, tablet, body worn device, weight or other health measuring device (e.g., thermometer, scale, etc.), or any other computing device capable of wired or wireless communication. In these cases, a user may enter personal descriptive information and the user may receive information associated with the sensor assemblies 100a, 100b.

[0043] The home base station can utilize the patient's home network to transmit collected data to the cloud. The home network, which may be a local area network, provides access from the patient's home to a wide area network, such as the Internet. In some configurations, the home base station may utilize a Wi-Fi connection to connect to the home network and access the Internet. In other embodiments, the home base station may be connected to the patient's home computer (not shown), such as via a USB connection, which is itself connected to the home network.

[0044] The smart device may communicate directly with the sensor assemblies 100a, 100b, for example, via Bluetooth®-enabled signals, may utilize the patient's home network to transmit collected data to the cloud, or may communicate directly with the cloud, for example, via a cellular network. Alternatively, the smart device may be configured to communicate directly with one or both of the base station and the connected personal assistant, for example, via Bluetooth®-enabled signals, and is not configured to communicate directly with the sensor assemblies 100a, 100b.

[0045] Additionally, the connected personal assistant may communicate directly with the sensor assemblies 100a, 100b, e.g., via Bluetooth®-enabled signals, may utilize the patient's home network to transmit collected data to the cloud, or may communicate directly with the cloud, e.g., via a modem / internet connection or cellular network. Alternatively, the connected personal assistant may be configured to communicate directly with one or both of the base station and the smart device, e.g., via Bluetooth®-enabled signals, and may not be configured to communicate directly with the sensor assemblies 100a, 100b.

[0046] In addition to transmitting collected data to the cloud, one or more of the home base station, the smart device, and the connected personal assistant may also obtain data, commands, or other information from the cloud, either directly from the cloud or via the home network. One or more of the home base station, the smart device, and the connected personal assistant may provide some or all of the received data, commands, or other information to the sensor assemblies 100a, 100b. Examples of such information include, but are not limited to, updated configuration information, diagnostic requests to determine whether the sensor assemblies 100a, 100b are functioning properly, data collection requests, and other information.

[0047] The cloud may include one or more server computers or databases for aggregating data collected from the sensor assemblies 100a, 100b, and in some cases, personal descriptive information collected from the patient, data collected from other intelligent implantable devices, and in some cases, personal descriptive information collected from other patients. In this manner, the cloud may generate a variety of different indicators regarding the data collected from each of multiple intelligent implantable devices implanted in separate patients. This information may be useful in determining whether the intelligent implantable devices are functioning properly. The collected information may also be useful for other purposes, such as determining which particular device may not be functioning properly, determining whether a treatment or condition associated with the intelligent implantable device is assisting the patient (e.g., whether a sensor system including the sensor assemblies 100a, 100b is operating properly), and determining other medical information.

[0048] At various points throughout the monitoring process, the patient may be requested to visit a medical professional for a follow-up appointment. This medical professional may be the surgeon who implanted the sensor assembly 100a, 100b in the patient, or a different medical professional who oversees the patient's monitoring process, physical therapy, and recovery. For a variety of different reasons, the medical professional may wish to collect real-time data from the sensor assembly 100a, 100b in a controlled environment. In some cases, the request to visit a medical professional may be delivered via any interactive user interface of one or more of the home base station, the smart device, and the connected personal assistant, respectively.

[0049] A physician can utilize a clinic base station in communication with the sensor assemblies 100a, 100b to pass additional data between the clinic base station and the sensor assemblies 100a, 100b. Alternatively, or additionally, a physician can utilize the clinic base station to pass commands to the sensor assemblies 100a, 100b. In some configurations, the clinic base station can instruct the sensor assemblies 100a, 100b to enter a high-resolution mode to temporarily increase the rate or type of data collected for a short period of time. The high-resolution mode instructs the sensor assemblies 100a, 100b to collect different (e.g., larger amounts of) data during an activity in which a medical professional is also monitoring the patient.

[0050] In some configurations, the clinic base station can allow the physician to enter an event marker that can be synchronized with the high resolution data collected by the sensor assemblies 100a, 100b. For example, assume that the sensor assemblies 100a, 100b are components in a sensor system adapted to be implanted within a joint. During a follow-up visit, the medical practitioner can place the sensor assemblies 100a, 100b in high resolution mode. The physician can review the sensor data from the sensor assemblies 100a, 100b to determine if the injury has healed (or is healing) and the implant is functioning properly. If the sensor data indicates there is a problem, the physician can take one or more corrective actions. After the medical practitioner has taken such one or more actions, the physician can click an event marker button on the clinic base station to mark the performance of such one or more actions. The physician's office base station records the marker and the time the marker was entered. Once the timing of this marker is synchronized with the timing of the collected high resolution data, the physician can analyze the data to determine the effectiveness of the medication.

[0051] In other configurations, the clinic base station may provide updated configuration information to the sensor assembly 100a, 100b. The sensor assembly 100a, 100b may store this updated configuration information, which may be used to adjust parameters associated with the collection of data. For example, if the patient is performing well, the physician may instruct the sensor assembly 100a, 100b to collect data less frequently. Conversely, if a defect or injury has not healed or the implant is not functioning properly, the physician may instruct the sensor assembly 100a, 100b to collect additional data for a determined period of time (e.g., several days). The medical practitioner may use the additional data to diagnose and treat a particular problem. In some cases, the additional data may include personal descriptive information provided by the patient after the patient leaves the physician's presence and is no longer within range of the clinic base station. In these cases, the personal descriptive information may be collected and delivered from one or more of the home base station, the smart device, and the connected personal assistant. The sensor assemblies 100a, 100b and / or antennas in the base station can provide protection to limit the duration of such enhanced monitoring to ensure that the battery retains sufficient power to last for the life cycle of the implant. Additionally or alternatively, the sensor assemblies 100a, 100b can include a conductive switch, described further below, that helps limit the monitoring of the sensor assemblies 100a, 100b.

[0052] In various configurations, the clinic base station may communicate with a clinic configuration computing device. The clinic configuration computing device may include an application having a graphical user interface that allows a physician to input commands and data. Some or all of the commands, data, and other information may later be transmitted to the sensor assemblies 100a, 100b via the physician's office base station. For example, in some configurations, a physician may use the graphical user interface to instruct the sensor assemblies 100a, 100b to enter their high resolution mode. In other configurations, a medical professional may use the graphical user interface to input or modify configuration information for the sensor assemblies 100a, 100b. The clinic configuration computing device may transmit information (e.g., commands, data, or other information) via a wired or wireless network connection (e.g., a USB connection, a Bluetooth connection, or a Wi-Fi connection) to the clinic base station, which may then transmit some or all of the information to the sensor assemblies 100a, 100b.

[0053] The physician's office configured computing device may also display other information (e.g., personal descriptive information) about the sensor assemblies 100a, 100b related to the patient or the physician's office base station to the physician. For example, the clinic configured computing device may display high resolution data collected by the sensor assemblies 100a, 100b and transmitted to the clinic base station. The physician's office configured computing device may also display error information if the sensor assemblies 100a, 100b cannot store or access configuration information, if the sensor assemblies 100a, 100b are unresponsive, if the sensor assemblies 100a, 100b identify a problem with one of the sensors or radios, if the physician's office base station is unresponsive or malfunctioning, or for other reasons.

[0054] In some configurations, the clinic-configured computing device may have access to the cloud. In at least one embodiment, a physician may utilize the clinic-configured computing device to access cloud-stored data previously collected by the sensor assemblies 100a, 100b and transmitted to the cloud via one or both of the home base station and the smart device. Similarly, the clinic-configured computing device may transmit high-resolution data obtained from the sensor assemblies 100a, 100b to the cloud via the clinic base station. In some configurations, the clinic base station may have internet access and may enable transmission of high-resolution data directly to the cloud without the use of the clinic-configured computing device.

[0055] In various configurations, a medical practitioner may update the configuration information of the sensor assemblies 100a, 100b when the patient is not at the clinic. In these cases, the physician may utilize a clinic configuration computing device to transmit the updated configuration information to the sensor assemblies 100a, 100b via the cloud. One or more of the home base station, the smart device, and the connected personal assistant may retrieve the updated configuration information from the cloud and pass the updated configuration information to the cloud. This allows the medical practitioner to remotely adjust the operation of the sensor assemblies 100a, 100b without the patient needing to come to the clinic. This may also allow the medical practitioner to send messages to the patient, for example, in response to personal descriptive information provided by the patient and passed through one or more of the home base station, the smart device, and the connected personal assistant.

[0056] Although the physician office base station and physician office configuration computing device are described as separate devices, the configuration is not so limited; rather, the functionality of the physician office configuration computing device and the physician office base station may be included in a single computing device or separate devices (as shown). In this manner, a medical practitioner may be enabled in one configuration to input configuration information or markers directly into the clinic base station and view high resolution data (and synchronized marker information) from a display on the clinic base station.

[0057] 2, alternative configurations are contemplated. For example, each of the base station, the smart device, and the connected personal assistant may be configured to communicate with one or both of the sensor assemblies 100a, 100b and the cloud via another one or two of the base station, the smart device, and the connected personal assistant. Furthermore, the smart device may be any suitable device other than a smartphone, such as any IoT device, such as a smart watch, a smart patch, and a coffee pot, that can be temporarily retracted and act as an interface to the sensor assemblies 100a, 100b. Furthermore, one or more of the base station, the smart device, and the connected personal assistant may act as a communication hub for multiple sensor assemblies 100a, 100b implanted in one or more patients. Additionally, one or more of the base station, smart device, and connected personal assistant may automatically order or reorder prescriptions or medical supplies (e.g., calcium antagonists) in response to patient input or sensor assembly 100a, 100b input (e.g., pain level, level of clotting) if a medical professional and insurance company have pre-approved such order or reorder, or alternatively, one or more of the base station, smart device, and connected personal assistant may be configured to request approval from a medical professional or insurance company to place the order or reorder. Additionally, one or more of the base station, smart device, and connected personal assistant may be configured with a personal assistant such as Alexa® or Siri®.

[0058] II. Sensor Assembly Any of the sensor assemblies described herein can be implanted in any joint, or more generally, in a patient's body. The specific example described below relates to a hip implant, but the systems and methods described herein are applicable to implants for the knee, shoulder, or elbow, implants in another joint, or implantable structures for any body part.

[0059] As shown in FIG. 3, the sensor assembly 300 may include an enclosure or housing 320 and an implantable reporting processor having one or more antennas 312 (sometimes referred to in the singular as antennas in this disclosure). The housing may enclose the electronic circuitry of the implantable reporting processor, which may include at least one of one or more sensors, a transceiver circuit, a controller, or a memory. The transceiver circuitry may include one or more of a radio frequency (RF) front end-matching network, one or more filters (such as one or more surface wave acoustic filters), and a transceiver. As described herein, the one or more sensors may monitor a patient condition, such as movement or range of motion. For example, the one or more sensors may include one or more of an accelerometer or a gyroscope to monitor whether the patient is standing, sitting, walking, or lying down, and to monitor gait, range of motion, etc. The one or more sensors may include temperature or current sensing. The antenna 312 may transmit data acquired by the one or more sensors to a receiver outside the patient's body. For example, the antenna 312 may transmit sensor data continuously, intermittently at regular time intervals, or in response to receiving a command. The antenna 312 may be connected to a transceiver via a feed. The antenna 312 may be at least partially covered.

[0060] The electronic circuitry may be supported by one or more printed circuit boards (PCBs). A power source (such as one or more batteries) may provide power to the electronic circuitry and antenna 312. One or more PCBs and power sources may be stacked vertically or horizontally to reduce the size of the sensor assembly 300.

[0061] In some instances, the electronic circuitry can operate in multiple modes. The electronic circuitry can operate in a first mode in which little power is consumed to conserve power. The first mode may be referred to as a low power mode or a sleep mode. The electronic circuitry can operate in a second mode in which at least some components of the electronic circuitry (one or more sensors, a controller, etc.) are operational. The second mode may be referred to as an operational mode. In some cases, the electronic circuitry can transition from a sleep mode to an operational mode in response to the antenna 312 receiving one or more signals (or commands) in a second frequency band (or in some cases, the first frequency band). In the operational mode, the electronic circuitry can, for example, collect data using one or more sensors and transmit the data (or any other data) via the antenna 312. The data may be transmitted in the first frequency band (or in some cases, the second frequency band). Additionally or alternatively, the data may be received via the antenna 312 in the first frequency band (or the second frequency band). The electronic circuitry may transition from the second mode to the first mode in response to receiving data (eg, a command) via antenna 312 and in response to expiration of the duration.

[0062] The sensor assembly 300 may be implanted into the patient's femur 132. As shown in Figure 3, the sensor assembly 300 may be positioned within or supported by the femoral stem 122. As another example, the sensor assembly 300 may be implanted directly into the femur 132, such as in an opening created during hip arthroplasty. The housing 320 may be made from a biocompatible material that may be electrically conductive (one or more of titanium or a titanium alloy, stainless steel, a cobalt-chromium alloy, etc.).

[0063] A. Antenna The antenna 312 is used to wirelessly transmit data to (and receive data from) the receiver. The transmitted data can be any data acquired by one or more sensors. Designing the antenna 312 can be non-trivial. The antenna can be subject to size constraints due to being positioned inside the body. The antenna 312 can be required to be as small as possible, so the antenna 312 or any of the antennas described herein can be an electrically small antenna (which can utilize one or more of the electronics or ground planes of the conductive housing 320 as a ground). The maximum dimension of the electrically small antenna can be less than or equal to one tenth of a wavelength of the RF signal received or transmitted by the antenna. In some cases, the height of the antenna 312 can need to be minimal so as not to impinge on any of the ligaments of the hip joint (or another joint or body part) or the like. The antenna 312 can be required to operate in multiple bands, such as the MICS band (402-405 MHz) and the ISM band (2.4-2.5 GHz). The MICS band can serve as a first frequency band, and the ISM band can serve as a second frequency band. In some embodiments, the antenna 312 can receive one or more wake-up commands in the second frequency band to transition the electronic circuitry from the first mode to the second mode. The antenna 312 can transmit data collected by one or more sensors in the first frequency band (as well as receive one or more commands related to the transmission of data in the first frequency band).

[0064] The antenna 312 may need to communicate with the base station over a desired distance, such as at least about 10 feet, about 15 feet, or about 20 feet or more.

[0065] In summary, an antenna 312 for use with a sensor assembly for a hip joint implant may need to have a very small form factor and operate in at least two frequency bands, such as the MICS and ISM frequency bands. However, some of the design parameters of the antenna 312 may be in conflict. For example, decreasing the size of the antenna 312 allows the antenna to operate at a higher frequency, but increasing the frequency (and shorter wavelength) will cause more loss in the tissue due to increased scattering (especially if the antenna is implanted in a joint and surrounded by significant layers of bone, muscle, fat, and skin). As another example, decreasing the operating frequency of the antenna 312 (and increasing the wavelength) will increase the operating distance (or range), but at the expense of making the antenna larger.

[0066] FIG. 4 illustrates an antenna design process 400 that may be used to design the antenna 312 (or any of the antennas described herein). Before designing the antenna, mechanical design constraints may need to be analyzed. The space in which the antenna is integrated and antenna size limitations may be analyzed in block 402, since the size of the antenna is related to the antenna performance at a particular frequency. After determining the space and antenna size limitations, the electromagnetic properties of the material surrounding the antenna (bone, muscle, fat, skin, etc.) may be analyzed in block 404. The electromagnetic properties may include one or more of the following: permittivity (or relative permittivity), electrical resistivity, and electrical conductivity, one or more of which may be frequency dependent. The electromagnetic properties of the surrounding material may affect the antenna performance by absorbing the energy radiated from (or received by) the antenna. The conductivity of the surrounding material, which may affect the antenna performance, may be considered in block 406, since materials with high electrical conductivity may absorb the energy radiated from (or received by) the antenna. For example, since metals have high electrical conductivity, the presence and conductivity of any metals proximate the antenna may be analyzed in block 406 .

[0067] Based on the analysis of blocks 402-406, a suitable antenna structure may be determined in block 408. As described herein, the antenna structure may be a loop antenna or a helical (spiral) antenna. The antenna structure may be a substrate antenna (sometimes referred to as a conformal antenna) that may be positioned (e.g., printed, painted, or otherwise deposited) on one or more substrate layers. In some cases, the substrate antenna may be a planar inverted-F antenna (PIFA), a serpentine (or serpentine) monopole antenna, or a slot antenna.

[0068] After designing the antenna structure at block 408, the performance of the antenna can be analyzed at block 410. The antenna performance can be characterized in terms of one or more of gain, bandwidth, radiation pattern, beam width, polarization, impedance, range, etc. As shown in block 412, the antenna performance should be within an acceptable range for a particular application. If the performance is not satisfactory, the antenna characteristics can be calibrated as shown in block 414. For example, the structure of the antenna can be adjusted by changing the shape or pattern of the antenna. As another example, the antenna can be adjusted to resonate at one or more desired frequencies or to match its impedance to a desired impedance (such as the impedance of a transceiver). Blocks 410, 414, and 406 can be repeated until the antenna exhibits satisfactory performance. The process 400 can end at block 416, where the antenna design can be finalized. Impedance matching can then be performed.

[0069] Software tools can be used to design and verify antennas (model radiation patterns, determine gain, determine return loss, impedance, etc.). The software tools can be finite element method solvers for three-dimensional electromagnetic structures, such as Ansys, Inc.'s High Frequency Structural Simulation Tool (HFSS).

[0070] For example, as shown in Figures 5A-5C, the antenna 312 can be designed in various types and shapes. For example, a loop antenna (Figure 5A), a substrate antenna (Figure 5B), a PIFA antenna (Figure 8), or a helix antenna (Figure 5C) may be used. The design and performance of these and other antennas are described below.

[0071] Loop antenna In some embodiments, a loop antenna 701 may be used with the sensor assembly 300. Figure 6 shows a cross-sectional view of the sensor assembly 300 with a loop antenna 701 supported by a base 702 (made of a conductive material and may serve as a ground for the loop antenna 701). A feed 703 to the loop antenna 701 is also shown. The feed 703 may connect the loop antenna to an electronic circuit (not shown in Figure 6) that may include a transmit / receive circuit. An antenna impedance matching circuit may connect the feed 703 and the transceiver. The loop antenna 701 may be designed to operate the antenna in the MICS and ISM bands.

[0072] 7A and 7B show the gain radiation patterns of the loop antenna 701 in the ISM and MICS bands, respectively. As shown in FIG. 7A and FIG. 7B, the loop antenna 701 has a peak gain of −37 decibels (dB) in the ISM band and −45 dB in the MICS band. FIG. 7C shows the impedance of the loop antenna 701 plotted on a Smith chart. The impedances 801 and 802 at the center frequencies of the MICS and ISM bands, respectively, are in the Smith chart. Using a matching network circuit, the impedances 801 and 802 can be adjusted to match the impedance of the transceiver (e.g., the 50 ohm point at the center of the Smith chart).

[0073] FIG. 7D shows the return loss (or S11 parameter) of the loop antenna 701 plotted as a function of frequency. The return loss may be a measure of the amount of power reflected from the antenna due to mismatch from the transmission line. The return loss may indicate the power not delivered to the antenna (and may indicate the amount of power radiated by the antenna). A smaller return loss (about -2 dB, about -3 dB, about -4 dB, about -5 dB, about -10 dB or less, etc.) may be preferred because it would indicate that a significant amount of energy was delivered to the antenna. In some cases, the target return loss may be about -5 dB or less or about -10 dB or less. FIG. 7D shows that the loop antenna 701 resonates at a single frequency of about 1 GHz instead of the desired center frequency of 403.5 MHz in the MICS band and 2.45 GHz in the ISM band.

[0074] b. PIFA antenna A PIFA antenna may be used with the sensor assembly 300. FIG. 8 shows a PIFA antenna 1000 supported by a substrate 1002. The PIFA antenna 1000 may include a conductive trace 1004 positioned (printed, painted, or otherwise deposited) on the substrate 1002. The conductive trace 1004 may be made of a material (one or more of gold, silver, platinum, graphite, copper, etc.) that may be positioned on the substrate 1002. The material may be biocompatible. In some cases, the material may be a conductive ink. The PIFA antenna 1000 may be a type of substrate antenna.

[0075] The substrate 1002 may be made of a non-conductive biocompatible material, such as liquid crystal polymer (LCP), polyimide, or polyamide, on which the conductive traces may be disposed. Biocompatibility may indicate that a material (such as the substrate material, conductive trace material, or other biocompatible material described herein) will not harm the body or interact negatively with living tissue when in contact with tissue, fluid, or generally chemicals in the body. Biocompatibility may indicate that a material will not induce an immune response, such as inflammation, irritation, or toxicity. A biocompatible material may be chemically inert. Biocompatibility may encompass biostability, which refers to the effect on a material from exposure to tissue, fluid, or generally chemicals in the body. A biostable material generally does not react with chemicals in the body. The material of the substrate 1002 may have long-term biocompatibility or biostability (such as one year or more) such that the material will not degrade or break down when exposed to fluids or chemicals in the body. Due to its long-term biostability, LCP may be a preferred material for the substrate 1002. In some implementations, the substrate 1002 may be made from a non-biocompatible material and coated with a biocompatible coating. The non-biocompatible substrate may be encapsulated in a biocompatible coating, such as a polytetrafluoroethylene (PTFE) coating, a fluorinated ethylene propylene (FEP) coating, parylene, acrylated urethane, or a combination thereof.

[0076] The substrate 1002 may be supported by a spacer 1006 (or support) that may separate the traces 1004 from the housing 320 of the sensor assembly. The spacer 1006 may be made of a non-conductive material (such as a thermoplastic material) and may act as a separator between the conductive material of the housing 320 and the conductive antenna traces to improve antenna performance. The spacer 1006 may be made of a biocompatible material (e.g., polyetheretherketone or PEEK or another biocompatible plastic). Varying the height of the spacer 1006 as described herein (e.g., in connection with block 406) may affect the properties of the antenna 1000. To increase the electrical length of the PIFA antenna 1000 (so that the antenna can resonate at one or more desired frequency bands), the antenna traces may be wrapped around the spacer 1006, as shown in FIG. 8. The spacer 1006 may be supported by a base 1008 (which may be similar to base 702). A feed (not shown in FIG. 10) can connect the PIFA antenna 1000 to electronic circuitry (not shown in FIG. 10), which can include transmit and receive circuitry. An antenna impedance matching circuit can connect the antenna feed and the transceiver. Although the PIFA antenna 1000 is illustrated as a circular structure, the antenna may be non-circular in some implementations.

[0077] Figures 9A and 9B show the gain radiation patterns of the PIFA antenna 1000 in the ISM and MICS bands, respectively. As shown in Figures 9A and 9B, the PIFA antenna 1000 has a peak gain of -44 dB in the ISM band and -32 dB in the MICS band. Figure 9C shows the impedance of the PIFA antenna 1000 plotted on a Smith chart. The impedances 1101 and 1102 at the center frequencies of the MICS and ISM bands, respectively, are in the Smith chart. Using a matching network circuit, the impedances 1101 and 1102 can be adjusted to match the impedance of the transceiver (e.g., the 50 ohm point at the center of the Smith chart).

[0078] FIG. 9D shows the return loss of the PIFA antenna 1000 plotted as a function of frequency. As shown, the PIFA antenna 1000 resonates at many frequencies (such as about 400 MHz, about 1 GHz, about 1.4 GHz, and about 1.7 GHz). This performance may be undesirable. For example, the presence of multiple resonant frequencies and narrow bandwidths may make it difficult to tune the PIFA antenna 1000 to operate in the MICS and ISM frequency bands and provide a suitable operating range. The return loss at a center frequency of 403.5 MHz (indicated at 1103) in the MICS band is about −2.8 dB. The return loss at a center frequency of 2.45 GHz (indicated at 1104) in the ISM band is about −1.3 dB. These return losses (especially in the ISM band) may be insufficient (e.g., indicating an insufficient amount of radiated power) for the PIFA antenna 1000 to operate in the MICS and ISM frequency bands and provide a suitable operating range.

[0079] 9E shows a matching network circuit 1150 (or matching circuit) of the PIFA antenna 1000 optimized for peak gain in the ISM and MICS frequency bands. The PIFA antenna 1000 may be tuned to improve performance in one or more frequency bands of interest. The matching circuit 1150 may be designed and connected to the PIFA antenna 1000 to provide one or more of reception or transmission in a first frequency band (such as the MICS band) and a second frequency band (such as the ISM band). As described herein, the matching circuit may be designed to account for the dielectric parameters of the tissue surrounding the sensing attachment.

[0080] The matching circuit 1150 may be electrically connected to the PIFA antenna 1000. The matching circuit may provide impedance matching between the antenna and the transceiver. FIG. 9E shows the matching circuit 1150 of the PIFA antenna 1000. The matching circuit 1150 may include a bottom portion designed to process signals of a first frequency band and an upper portion designed to process signals of a second frequency band. The port 1170 may be connected to a transceiver that may operate in the first and second frequency bands. In some cases, a filter may be inserted between the PIFA antenna 1000 and the transceiver. For example, a filter may be connected to the port 1170.

[0081] The matching network 1152 can process signals in a second frequency band. The matching network 1152 can be inductive. The matching network 1152 is illustrated as an L network including two inductors (such as a shunt inductor L300 and a series inductor L304). The matching network 1152 can be designed as illustrated to match (or counter) the capacitive reactance of the PIFA antenna 1000 in the second frequency band (such as a higher frequency).

[0082] A bandstop (or notch) filter 1151 can be used to remove higher frequency components from a signal in a first frequency band. The notch filter can remove one or more signal components in a second frequency band from a signal received (or transmitted) in the first frequency band. The notch filter 1151 is shown as a combination of an inductor L303 connected in parallel with a capacitor C306. The notch filter may not be included in the matching network of the second frequency band to avoid or reduce undesirable parasitic effects (such as one or more parasitic capacitances or inductances) at the higher frequencies of the second frequency band.

[0083] The matching network 1153 can process signals in the first frequency band. The matching network 1153 can be capacitive. The matching network 1153 is illustrated as a Pi network including two capacitors (such as shunt capacitors C52 and C53 and a series inductor L222). The matching network 1153 can be designed as illustrated to match (or counter) the inductive reactance of the PIFA antenna 1000 in the first frequency band (such as lower frequencies). The top and bottom outputs of the matching circuit 1150 can be connected to the PIFA antenna 1000. In some cases, the output port 1160 can connect the output of the PIFA antenna 1000 to a network analyzer (such as a vector network analyzer (VNA)). The network analyzer can be used to measure the s-parameters (such as the S11 parameter) of the PIFA antenna 1000. FIG. 9F shows the return loss (or S11 parameter) of the PIFA antenna 1000 connected to an optimized ISM band matching circuit (such as the matching circuit 1150). As shown, the PIFA antenna 1000 resonates at several frequencies (such as about 400 MHz, about 1.6 GHz, about 1.94 GHz, and about 2.91 GHz). The return loss at a center frequency of 2.45 GHz in the ISM band (shown as 1155) is about -16.5 dB. Compared to FIG. 9D, the addition of an optimized ISM band matching circuit (e.g., matching circuit 1150) to the PIFA antenna 1000 can significantly improve the antenna performance (especially in the ISM band).

[0084] 9G shows the return loss (or S11 parameter) of the PIFA antenna 1000 connected to an optimized MICS band matching circuit (such as matching circuit S1150). As shown, the return loss of the PIFA antenna 1000 at a center frequency of 403.5 MHz in the MICS band (shown at 1156) is about -9.8 dB. Compared to FIG. 9D, the addition of an optimized MICS band matching circuit (e.g., matching circuit 1150) to the PIFA antenna 1000 can improve antenna performance (especially within the MICS band).

[0085] c. PCB antenna As shown in FIG. 10, a substrate antenna 1200 may be used with the sensor assembly 300. Similar to the PIFA antenna 1000, the substrate antenna 1200 may include conductive traces positioned (printed, painted, or otherwise deposited) on a substrate 1202 (which may be similar to the substrate 1002). The substrate 1202 may be made of a non-conductive long-term biocompatible material, such as liquid crystal polymer (LCP), polyimide, or polyamide. In some cases, another layer (or seed layer) may be positioned on the substrate 1202 to facilitate adhesion of the conductive traces (which may also be applicable to the PIFA antenna 1000). Such a layer may be made of titanium. The substrate 1202 may be supported by a spacer 1206 (which may be similar to the spacer 1006), which is supported by a base 1208 (which may be similar to the base 702 or 1008). The spacer 1206 may be made of a biocompatible material (such as PEEK or another biocompatible plastic). The feed 1203 can connect the substrate antenna 1200 to electronic circuitry (not shown in FIG. 10), which can include transmit and receive circuitry. An antenna impedance matching circuit can connect the antenna feed 1203 and the transceiver. The substrate antenna 1200 can be referred to as a single layer substrate antenna because the conductive traces are located only on one layer of the substrate 1202. In some implementations, as described herein, the substrate antenna can include conductive traces located on multiple layers (such as a top layer and a bottom layer) of the substrate 1202.

[0086] The conductive traces may be arranged in a set of outer traces 1210 and a set of inner traces 1212. The two sets of traces 1210 and 1212 may be connected at 1214. The set of inner traces 1212 may be connected to the feed 1203 at a feed point 1216 located at the center of the circle. The set of outer traces (or outer ring) 1210 may include multiple sections shaped as petals that may be connected to one another. Similarly, the set of inner traces (or inner ring) 1212 may include multiple sections shaped as petals that may be connected to one another. Shaping the traces as petals may result in a design in which the traces are symmetrically arranged around the feed point 1216, which has been found to improve the properties of the substrate antenna 1200. The spacing of the petals in one or more sets of traces 1210 or 1212 may affect the resonance of the substrate antenna 1200. For example, positioning the petals closer together may improve the resonance of the substrate antenna 1200 in one or more of the MICS or ISM bands. Adding more petals to one or more sets of traces 1210 or 1212 can increase the electrical length of the substrate antenna 1200 and improve resonance in one or more of the MICS or ISM bands. Rounding corners, such as "V" shaped corners, can affect the resonance of the substrate antenna 1200. Although a petal shaped section is illustrated in FIG. 10, other symmetrical (or asymmetrical) shapes can be used (e.g., as described in connection with FIG. 18). For example, a zigzag pattern of traces can be used, as shown in FIG. 18).

[0087] The substrate antenna 1200 may include a stub 1220, which may be a round trace connected to the set of inner traces 1212. As described herein, varying the length of the stub 1220 can improve the performance of the substrate antenna 1200.

[0088] Although substrate antenna 1200 is illustrated as a circular structure, the antenna may be non-circular in some implementations.

[0089] FIG. 11A shows the impedance of the substrate antenna 1200 plotted on a Smith chart. Impedances 1301 and 1302 at the center frequencies of the MICS band and ISM band, respectively, are in the Smith chart. Using a matching network circuit, the impedances 1301 and 1302 can be adjusted to match the transceiver impedance (e.g., the 50 ohm point at the center of the Smith chart). FIG. 11B illustrates the return loss of the substrate antenna 1200 plotted as a function of frequency. As shown, the return loss at the center frequency of 403.5 MHz (indicated at 1303) in the MICS band is about −11.8 dB. The return loss at the center frequency of 2.45 GHz (indicated at 1304) in the ISM band is about −8.7 dB. Advantageously, these return losses indicate that the loss of power due to reflection is low for the substrate antenna 1200.

[0090] The antenna 1200 may be tuned to improve performance. Tuning may involve changing the length of the stub 1220. FIG. 12 shows return loss plotted as a function of frequency for different lengths of the stub 1220. Specifically, the substrate antenna 1200A has a full length stub 1220A (corresponding to the stub 1220 of the substrate antenna 1200 of FIG. 10). The substrate antenna 1200B has a stub 1220B with a length trimmed by 25% compared to the stub 1220A. The substrate antenna 1200C has a stub 1220C with a length trimmed by 50% compared to the stub 1220A. Plot 1410A shows the return loss of the antenna 1200A. Plot 1410B shows the return loss of the antenna 1200B. Plot 1410C shows the return loss of the antenna 1200C. As shown, trimming the stub by 25% and 50% shifts the resonant frequency in the high frequency band close to the 2.45 GHz frequency in the ISM band and reduces the return loss in the ISM band.

[0091] Tuning may involve changing the height of the spacer 1206. Increasing the height of the spacer may improve the performance of the antenna 1200, which may result from moving the antenna away from the conductive housing 320. FIG. 13 shows return loss plotted as a function of frequency for different heights of the spacer 1206. Plot 1512 shows the return loss of the antenna 1200 with a shorter spacer 1206 (e.g., about 4.3 mm). Plot 1514 shows the return loss of the antenna 1200 with a longer spacer 1206 (e.g., about 10 mm). As shown, the resonance of the antenna and gain is improved in the MICS band with the longer spacer 1206.

[0092] The traces of the substrate antenna may be positioned (e.g., by deposition, such as by printing or painting) on ​​upper and lower layers of the substrate 1202. For example, the sets of traces 1210 and 1212 may be separately positioned on opposing layers of the substrate 1202. In such an arrangement, the sets of traces 1210 and 1212 may be connected by one or more conductive vias, as described herein. For example, a conductive via may connect the two sets of traces 1210 and 1212.

[0093] The traces of the substrate antenna may be located (e.g., printed, painted, or otherwise deposited) on multiple layers of one or more substrates or on multiple substrates. FIG. 14 illustrates a substrate antenna 1700 including two substrates 1702 and 1702′ supporting conductive traces 1704 and 1704′. For example, the conductive trace 1704 may provide operation in the MICS band, and the conductive trace 1704′ may provide operation in the ISM band (or vice versa). The conductive traces 1704 and 1704′ may be connected by one or more conductive vias 1706, which may include a conductive biocompatible material (which may be the same material as that of the conductive traces). In some cases, a single via 1706 may connect the conductive traces 1704 and 1704′. As illustrated, the via 1706 passes through the substrate 1702. In some implementations, when two or more substrates are used, two or more vias may be used. The substrates 1702 and 1702′ may be similar to the substrate 1202. The substrate antenna 1700 may be a three-layer antenna with conductive traces positioned on the top and bottom layers of the substrate 1702 and on the top layer (or bottom layer) of the substrate 1702'. A feed 1703 (which may be similar to the feed 1203) may connect the conductive traces to electronic circuitry 1730, which may include transmit and receive circuitry. In some cases, the substrate antenna may have four or more layers.

[0094] Layer 1708 may include a conductive material that forms a ground plane. Such a ground plane may improve the gain of the antenna by facilitating reflection of RF energy. A ground plane may be similarly located (e.g., printed, painted, or otherwise deposited) on the opposite side of substrate 1202 of FIG. 10. Conductive traces may be connected to the ground plane through vias or feeds 1703.

[0095] As mentioned above, any of the antennas described herein can be grounded. Proper grounding can be important for electrically small antennas. FIG. 15 illustrates the grounding of a substrate antenna 1800 positioned on a substrate 1802 (which can be similar to substrate 1202). The antenna shown is a substrate antenna, but any of the antennas described herein can be grounded in a similar manner. The substrate antenna 1800 can be connected to a ground plane of an electronic circuit 1830 through a feed 1803 (which can be similar to feed 1203). The ground plane of the electronic circuit 1830 can be tied to one or more of a power supply 1840 and a housing (not shown). As a result, the substrate antenna 1800 can be connected to a large ground plane (which can be floating). This can be used to shape the radiation pattern and improve the gain of the antenna 1800.

[0096] The substrate antenna can have various shapes, as illustrated in FIG. 16. The conductive traces can be arranged on the substrate (such as substrate 1202) in a pattern 1920 (two wedges) to form a single slot antenna, or in a pattern 1922 (four wedges) to form a cross (or T) antenna. Adjusting one or more ground pins can change the polarization of the substrate antenna. The conductive traces can be arranged on the substrate in a pattern 1924, 1926, 1928, or 1930. The patterns 1924, 1926, 1928, and 1930 can correspond to variations of U-shapes and Pi-shapes for the purpose of obtaining double resonance. The conductive traces can be arranged on the substrate, for example, as six wedges (1932), eight wedges (1934), etc. The wedges can be the same size (such as 1920 and 1922) with different sizes (such as 1932). The conductive traces may be arranged on the substrate as an incomplete set of petals (1936, 1938) with stubs. Additional petals may be added to the inner and outer rings to increase the electrical length of the substrate antenna 1200 and obtain desired resonant characteristics as described herein. A multi-layer petal-shaped substrate antenna 1800 may be designed. In some examples, a single layer substrate antenna 1200 may be designed by folding petals from one of the layers of the substrate in a two-layer configuration onto a single layer of the substrate to obtain the inner and outer rings. Advantageously, a single layer substrate antenna may be easier and cheaper to manufacture than a multi-layer substrate antenna.

[0097] FIG. 17 shows a table 1950 comparing the performance of various antennas described herein, including the substrate antenna 1200, the helix antenna 1900, the loop antenna 701, and the PIFA antenna 1000. The performance of the various antennas has been simulated (e.g., using a 3D finite element methodology solver) taking into account surrounding conductive components such as one or more of the electronic circuitry, power source, housing, or implant. The performance of the various antennas described herein has been simulated not only in free space, but also taking into account muscle, bone, fat, skin, etc. of the body part in which the antenna is deployed. The frequency-dependent relative permittivity (Er) and conductivity (Sigma) of such one or more tissues may be considered during the simulation.

[0098] For example, the following relative permittivity and conductivity values ​​can be used to test the performance of various antennas: [Table 1]

[0099] Phantoms can be made to simulate the relative permittivity and conductivity listed in the table above. In some cases, phantoms can be made to mimic tissues with the highest relative permittivity and conductivity (such as muscle). Phantoms can be made from a combination of diacetin and water. Various antennas along with electronic circuits, power sources, housings, and implants can be positioned within the phantoms (such as immersion) to test performance.

[0100] As confirmed by table 1950, the substrate antenna 1200 exhibits the best return loss (S11) in the MICS and ISM bands. Although the PIFA antenna 1000 exhibits good return loss, the amount of power radiated is less than that of the substrate antenna 1200. The amount of power radiated by the loop antenna 701 (and the helical antenna 1900) may be too low (especially in the MICS band) to provide adequate performance. One of the reasons for such insufficient amount of power radiated by the loop antenna 701 (and the helical antenna 1900) may be space constraints for use in hip joint implants (especially vertical constraints).

[0101] 19A and 19B show an exemplary implementation of a femoral implant 120 having a sensor assembly including an implantable reporting processor with an antenna. The antenna may be a substrate antenna 1200 positioned within a cavity of a femoral stem 122, as shown in FIG. 19A. The substrate antenna 1200 may be positioned on a spacer, such as spacer 1206 described herein. The femoral implant may include a femoral head 124 attached to the femoral stem 122, as shown in FIG. 19B.

[0102] 19A and 19B, the antenna protrudes from femoral implant 120. Any of the antennas disclosed herein may protrude from any of the implants.

[0103] 20A shows a matching network circuit 2000 (or matching circuit) for the substrate antenna 1200 optimized for peak gain in the ISM and MICS frequency bands. The substrate antenna 1200 can be tuned to improve performance in one or more frequency bands of interest. The matching circuit 2000 can be similar to the matching circuit 1150 of the PIFA antenna 1000 shown in FIG. 9E. The ports 2002 and 2004 can be similar to the ports 1160 and 1170 described above.

[0104] The notch filter 2010 for processing signals in a first frequency band may be similar to the above-described notch filter 1151. The L network 2020 may process signals in a second frequency band similar to the matching network 1152, as described above. Additionally, the Pi network 2030 may process signals in a first frequency band similar to the matching network 1153.

[0105] 20B shows the return loss (or S11 parameter) of the substrate antenna 1200 connected to an optimized ISM band matching circuit (such as matching circuit 2000). As shown, the substrate antenna 1200 resonance is approximately at the center of the ISM band at 2.45 GHz (indicated by 2050), with a peak return loss of approximately -18.75 dB. Compared to FIG. 11B, adding an optimized ISM band matching circuit (such as matching circuit 2000) to the substrate antenna 1200 can improve the antenna performance (e.g., by shifting the resonance peak to the center of the ISM band).

[0106] 20C illustrates the return loss (or S11 parameter) of the substrate antenna 1200 connected to an optimized MICS band matching circuit (such as matching circuit 2000). As shown, the return loss of the substrate antenna 1200 is approximately in the center of the MICS band at 403.5 MHz (indicated by 2060), with a peak return loss of approximately -29 dB. In comparison to FIG. 11B, the addition of an optimized ISM band matching circuit (e.g., matching circuit 2000) to the substrate antenna 1200 can improve antenna performance (e.g., by shifting the resonance peak to the center of the MICS band and improving return loss).

[0107] Different mechanical structures near the antenna can affect the resonance (and performance) of the antenna. Figure 21A shows the return loss plotted as a function of frequency for various configurations of the substrate antenna 1200. Plot 120C shows the return loss of the substrate antenna 1200 tested without the femoral implant 120. Plot 120B shows the return loss of the substrate antenna 1200 positioned within the cavity of the femoral stem 122 of the femoral implant 120, as shown in Figure 19A. Plot 120A shows the return loss of the substrate antenna 1200 within the cavity of the femoral stem 122 and with the femoral head 124 attached to the femoral stem 122 of the femoral implant 120, as shown in Figure 19B. FIG. 21A shows that when a more conductive material (such as a metal) of the femoral implant 120 is positioned near the substrate antenna 1200, the lower band response and higher band response of the substrate antenna 1200 shift to higher peak return loss values, especially in higher frequency bands (lower return loss may indicate better resonance), thereby indicating a deterioration in the performance of the antenna 1200 in the presence of the femoral implant 120.

[0108] In some cases, the antenna 1200 may be designed as an omnidirectional antenna in free space, but the performance of the antenna in the presence of the femoral implant 120 may not be omnidirectional. In some cases, when the antenna 1200 is placed in the femoral stem 122, the presence of the femoral head 124 may create nulls in the three-dimensional radiation pattern of the antenna. These nulls may be in undesirable locations (or directions) when attempting to transmit or receive data in directions away from the patient's side. As a result, it may be advantageous to design the antenna so that it does not have nulls in at least one or more locations (or directions) of interest.

[0109] The structure of the substrate antenna 1200 may be optimized to improve antenna performance. For example, the antenna may be optimized to have no nulls at one or more locations of interest. Optimization may involve adding more conductive material to the substrate antenna 1200 to combat the nulls (e.g., to shape the beam for peak gain at one or more locations of interest). In some cases, this may include wrapping conductive material around the spacer 1206 of the substrate antenna 1200 (such a substrate antenna may be referred to as a modified substrate antenna).

[0110] FIG. 21B is an exemplary implementation of a modified substrate antenna 2100. The modified substrate antenna 2100 may be positioned on a spacer 1206 as described in connection with FIG. 10 and may include a conductive trace (or traces) 2110 wrapped around the spacer 1206. As shown in FIG. 21B and FIG. 21D, the conductive trace 2110 may be doubled (to increase the electrical length of the modified substrate antenna 2100) and wrapped around both sides of the spacer 1206. The conductive trace 2110 may be positioned on the spacer 1206 as illustrated with the goal of being on the opposite side of the femoral head 124 to shift the transmission null. In some cases, the conductive trace 2110 may be triple, quadruple, etc., or not folded at all. The conductive trace 2110 may be positioned (e.g., printed, painted, or otherwise deposited) on the spacer 1206.

[0111] 21C, the conductive trace 2110 can be attached to one of the sections of the outer trace 1210 (or in some implementations to one of the sections of the inner trace 1212 or to the feed point 1216) to form an electrical connection with the traces of the modified substrate antenna 2100. Such an arrangement can be advantageous for deployment since the only solder connection required can be the connection at the feed point 1216.

[0112] The conductive trace 2110 may be wrapped one or more times around the base of the spacer 1206. For example, the conductive trace 2110 may be wrapped up and down the spacer 1206 to potentially cover additional surface area and further increase the electrical length of the modified substrate antenna 2100. In some cases, the conductive trace 2110 may be arranged such that the conductive trace 2110 is wrapped around a portion of the spacer 1206. As shown in FIG. 21E, the conductive trace 2110 may be wrapped in a spiral pattern around the spacer 1206.

[0113] The conductive traces 2110 may include a combination of two or more conductive traces of varying widths. The conductive traces 2110 may include a combination of two or more conductive traces wrapped completely or partially around a spacer.

[0114] The modified substrate antenna 2100 may include a stub (such as stub 1220) as shown in Figure 21C. In some cases, the stub may be omitted.

[0115] Any of the antennas disclosed herein may be covered with a cover that may resemble a radome. The cover may protect the antenna from damage and enhance biocompatibility. This may be particularly applicable to antennas that protrude from the implant or are positioned at a different location from the implant. FIG. 22A illustrates a covered antenna 2202A. The illustrated antenna 2202A may be similar to the modified substrate antenna 2100. The cover 2210A may encapsulate the substrate antenna assembly, the conductive traces 2110, and the spacer 1206 that supports the conductive traces 2110, as illustrated. The cover 2210A (or any of the covers disclosed herein) may be made of a biocompatible material such as PEEK or another biocompatible plastic. The use of PEEK may be advantageous due to its elastic and crush-resistant properties. For antenna structures where the spacer 1206 does not support the conductive antenna components, the cover may cover only the antenna assembly without extending to the spacer 1206.

[0116] The cover 2210A has a spherical shape with a smooth top surface, as also shown in FIG. 23A. Other cover shapes can be used. Referring to FIG. 22B, the covered antenna 2202B includes FIG. 2210B23B. The illustrated antenna may be similar to the modified substrate antenna 2100, except that it does not have a stub. In some cases, a stub may be included. The top portion of the cover 2210B may be shorter than the top portion of the cover 2210A, which is particularly visible by comparing FIG. 23A with FIG. 23B. 23A 23B FIG. 23C illustrates another cover shape that is spherical, but has a flat top, and therefore a smaller height than the cover 2210A (compare FIG. 23A with FIG. 23C).

[0117] Different cover shapes can offer various advantages and disadvantages. A smooth cover shape, such as that of cover 2210A, may be preferred for implantation into the body because it does not have sharp edges. However, a smoother cover shape may have a higher profile, which may make it more difficult to use in applications where vertical space is limited (such as hip implants). In some cases, a modified spherical cover shape illustrated in FIG. 23C may be preferred due to its combination of smoothness and low vertical profile.

[0118] 24A shows the return loss (or S11 parameter) of the covered antenna 2202A as a function of frequency. The covered antenna 2202A can be connected to an optimized ISM and MICS band matching circuit (such as matching circuit 2000). As shown, the covered antenna 2202A resonance is approximately centered in the ISM band at 2.4555 GHz (shown at 2420A) with a peak return loss of approximately -6.28 dB. The return loss of the covered antenna 2202A is approximately centered in the MICS band at 403.0 MHz (shown at 2410A) with a peak return loss of approximately -14.6 dB.

[0119] FIG. 24B shows the return loss (or S11 parameter) of the covered antenna 2202B as a function of frequency. The covered antenna 2202B can be connected to an optimized ISM and MICS band matching circuit (such as matching circuit 2000). As shown, the covered antenna 2202B resonance is approximately in the center of the ISM band at 2.4555 GHz (indicated by 2420B) with a peak return loss of approximately -7.05 dB. The return loss of the covered antenna 2202B is approximately in the center of the MICS band at 403.0 MHz (indicated by 2410B) with a peak return loss of approximately -29.04 dB. The return loss of the covered antennas 2202A and 220B is acceptable, but in simulations, the covered antenna 2202B exhibited better return loss than the covered antenna 2202A due to the reduced vertical profile of the cover 2210B. 2210B

[0120] The communication range of various antenna configurations was tested under simulated conditions, where an implant with an antenna was immersed in a phantom to simulate the positioning of the implant in the body. Tests were performed in the MICS frequency band to determine the wake-up range, but tests in the ISM frequency band are performed as well. FIG. 25A shows the wake-up range 2200 plotted as a function of different wake-up channels for various antenna configurations tested in free space (e.g., outdoors). The different wake-up channels may correspond to different frequencies in the MICS frequency band. In some cases, the substrate antenna 1200 and the modified substrate antenna 2100 are each disposed in a femoral implant 120 (illustrated by FIG. 19B) and positioned in a phantom having a dielectric constant and conductivity similar to muscle (as described above). The femoral head 124 of the femoral implant 120 can be rotated 90 degrees from the base station, thereby positioning the antenna in the center of the phantom. As described, this configuration may represent a worst-case transmission scenario since the antenna is deep in the simulated muscle tissue and communication occurs from the side of a patient lying on a bed. The modified substrate antenna 2100 has improved wake-up range across all wake-up channels when tested in such a worst-case scenario, compared to the substrate antenna 1200. The wake-up communication range of the modified substrate antenna 2100 may exceed 30 feet and may not drop below 10 feet. As shown in FIG. 21B and elsewhere, wrapping a conductive trace 2110 around the spacer 1206 of the substrate antenna 1200 may improve the communication range of the antenna. In some cases, adding a conductive trace 2110 to the substrate antenna may solve the problem of a transmission null in the direction of interest (e.g., forward direction).

[0121] The wake-up range of the covered antennas 2202A and 2202B was tested in free space (e.g., outdoors) as well as indoors. FIG. 25B shows the wake-up range of the covered antenna 2202A tested outdoors as a function of different wake-up channels. The communication range of the antenna 2202A was tested in side and forward directions (representing the worst case). In some cases, when tested in free space, the wake-up communication range of the covered antenna 2202A reaches 20 feet and does not drop below 10 feet. Other transmission directions were tested (e.g., reverse) and it was confirmed that the wake-up communication range of the covered antenna 2202A in free space does not drop below 10 feet.

[0122] 25C shows the wake-up range of the covered antenna 2202B, also tested outdoors, as a function of different wake-up channels. As shown, the wake-up communication range of the covered antenna 2202B in free space reaches 30 feet and does not drop below 20 feet. In this test, the covered antenna 2202B exhibited a longer wake-up communication range in the front configuration than the covered antenna 2202A. Other transmission directions were tested (such as reverse) to confirm that the wake-up communication range of the covered antenna 2202B in free space did not drop below 20 feet.

[0123] As shown in Figures 25D and 25E, indoor tests were also performed. Due to interference and distortion resulting from multipath transmission, the wake-up range is expected to degrade compared to free space. Similar to Figure 25B, Figure 25D shows the wake-up range of the covered antenna 2202A tested indoors as a function of different wake-up channels. In some cases, the wake-up communication range of the covered antenna 2202A indoors reaches 20 feet and does not drop below 10 feet. Other transmission directions were tested (such as reverse) to confirm that the wake-up communication range of the covered antenna 2202A did not drop below 10 feet.

[0124] Similar to Fig. 25C, Fig. 25E shows the wake-up range of the covered antenna 2202B tested indoors as a function of different wake-up channels. In some cases, the wake-up communication range of the covered antenna 2202B reaches 20 feet indoors and does not drop below 10 feet. Other transmission directions were tested (such as reverse) and confirmed that the indoor wake-up communication range of the covered antenna 2202B did not drop below 10 feet.

[0125] B. Sensor As described herein, the sensor assembly 300 (or any of the other sensor assemblies disclosed herein) may include one or more sensors. A sensor refers to a device that may be utilized to detect, measure, and / or monitor one or more different aspects of a body tissue (e.g., anatomy, physiology, metabolism, and function), one or more aspects of a body or body segment status or function (e.g., movement), and / or one or more aspects of the sensor assembly 300. The one or more sensors may be configured to detect movement (e.g., steps), rotation, pressure, etc., which generates data associated with one or more physiological parameters of the patient or implant.

[0126] Representative examples of sensors suitable for use in the sensor assembly 300 include, for example, fluid pressure sensors, fluid volume sensors, contact sensors, position sensors, orientation 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), impedance sensors, electrodes, accelerometers, gyroscopes, mechanical stress sensors, and temperature sensors. In some configurations, at least one of the one or more sensors may have a unique sensor identification number (USI) that uniquely identifies the sensor.

[0127] The one or more sensors may be configured to detect, measure, and / or monitor information related to a status of the sensor assembly 300 after implantation. The status of the sensor assembly 300 may include the integrity of the sensor assembly 300, the movement of the sensor assembly 300, forces exerted on the sensor assembly 300, and other information related to the sensor assembly 300.

[0128] The one or more sensors may be configured to detect, measure, and / or monitor body tissue related information (e.g., one or more physiological parameters of the patient) after implantation of the sensor assembly 300. Body tissue monitoring may include blood pressure, pH level, oxygen, carbon dioxide, potassium, iron, and / or glucose in the patient's blood. The one or more sensors may include a fluid pressure sensor, a fluid volume sensor, a pulse pressure sensor, a blood volume sensor, a blood flow sensor, a chemical sensor (e.g., for blood and / or other fluids), a metabolic sensor (e.g., for blood and / or other fluids).

[0129] Radiopaque markers, or other types of markers, may be integrated with the one or more sensors such that the location of the one or more sensors can be tracked within the vasculature using standard fluoroscopy techniques.

[0130] C. Processor / Controller The sensor assembly 300 (or any of the other sensor assemblies disclosed herein) may include a processor (or controller) in electrical communication (e.g., via transmit / receive circuitry) with one or more sensors and / or antenna 312. The one or more sensors and the processor may be located on a printed circuit board. Alternatively, some or all of the one or more sensors may be located in or on another structure of the sensor assembly 300 separate from the printed circuit board. The processor, which may be any suitable microcontroller or microprocessor, may be configured to control the configuration and operation of one or more of the other components of the sensor assembly 300. For example, the processor may be configured to control one or more sensors to sense associated measurement data or physiological parameters, store measurement data generated by the one or more sensors in memory, generate messages, include the stored data as payloads, packetize the messages, and provide message packets to the antenna 312 for transmission to a receiver (e.g., a hub in the patient's body, or a base station or other computing device outside the patient's body). The processor may be configured to execute commands received from the base station or other computing device via the antenna 312. For example, the processor may be configured to receive configuration data from a base station and provide the configuration data to components of the sensor assembly 300 to which the base station directs the configuration data. When the base station directs the configuration data to the processor, the processor may configure itself in response to the configuration data.

[0131] The processor may cause one or more sensors to detect whether a measurement is a qualified or valid measurement, store data representing the valid measurement, and cause the antenna 312 to transmit the stored data to a base station or other source external to the sensor assembly 300. In response to being polled by the base station or by another device external to the sensor assembly 300, the processor may generate a conventional message having a payload and a header. The payload scan may include stored samples of signals generated by one or more sensors. The header may include the sample partition within the payload, a timestamp indicating when the sensor took the sample, an identifier for the sensor assembly 300 (e.g., a serial number), and / or a patient identifier (e.g., a number or name).

[0132] The processor can generate data packets including the message according to a conventional data packetization protocol. Each packet can also include a packet header including, for example, a packet sequence number so that a receiving device can properly sequence the packets when they are transmitted or received. The processor can encrypt some or all of each of the data packets, for example, according to a conventional encryption algorithm, and error code the encrypted data packets. For example, the processor can encrypt at least the sensor assembly 300 and a patient identifier to make the data packets compliant with the Health Insurance Portability and Accountability Act ("HIPAA"). The processor can provide the encrypted and error encoded data packets to the antenna 312, which transmits the data packets through a filter to a destination, such as the base station 4 (shown in FIG. 1) or a receiver external to the sensor system. The antenna 312 can transmit the data packets according to any suitable data packet transmission protocol.

[0133] Alternative configurations of the sensor assembly 300. For example, the antenna 312 may perform encryption or error coding instead of or complementary to the processor. Additionally, the sensor assembly 300 may include components other than those described herein and may omit one or more of the components described herein.

[0134] The sensor assembly 300 may include a memory circuit (not shown), which may be any suitable non-volatile memory circuit, such as an EEPROM or FLASH memory. The memory may be in electrical communication with the processor, the antenna 312, and / or the one or more sensors. The memory may be configured, for example, to store data written by the processor or the antenna 312 and to provide data in response to a read command from the processor.

[0135] D. Power supply The sensor assembly 300 (or any of the other sensor assemblies disclosed herein) may include one or more power sources. For example, the sensor assembly may include one or more batteries and / or supercapacitors. The power source may be sized to fit within a body portion (such as the femur) with the rest of the sensor assembly 300. In other configurations, the sensor assemblies 100a, 100b may be powered by a power source located remote from the body site, either within the patient's body or outside the patient's body.

[0136] The power source may be any suitable battery, such as a Lithium Carbon Monofluoride (LiCFx) battery or solid-state battery, or other storage cell capable of storing energy (e.g., a supercapacitor) to power the processor for the expected life (e.g., at least one month or at least six months) of the sensor assembly 300. The power source may receive sufficient energy from the sensor reaction by-products to maintain a minimum power capacity to maintain the microcontroller memory, real-time clock, and / or SRAM sleep mode.

[0137] It is often undesirable to replace a power source implanted in a patient, at least because it involves invasive procedures that are relatively expensive and may have adverse side effects such as infection and pain. Therefore, the power source may be rechargeable. For example, the power source may be recharged using an integrated circuit on an ASIC chip. As another example, the battery may be inductively charged. For example, any of the sensor assemblies disclosed herein may include an antenna (such as a coil antenna) for wireless charging. Any of the garments disclosed herein may include a wireless power transmitter to facilitate inductive charging.

[0138] E. Spinal Implant As described herein, any of the sensor assemblies disclosed herein may be implanted in any joint or body part. For example, any of the sensor assemblies described herein may be implanted in the spine. Spinal procedures such as spinal fusion can generally refer to surgery and associated implantable medical devices such as spinal implant systems (e.g., spinal fusion implants such as spinal interbody cages or spacers, rods or plates, or spinal non-fusion implants such as artificial discs or expandable rods). Examples of spinal devices and implants include pedestal screws, spinal rods, spinal wires, spinal plates, spinal cages, artificial discs, facet implants, bone cement, and combinations thereof (e.g., one or more pedestal screws and spinal rods, one or more pedestal screws and spinal plates). Additionally, medical delivery devices for placement of spinal devices and implants, along with one or more sensors, may be intelligent medical devices according to the present disclosure. Examples of medical delivery devices for spinal implants include kyphoplasty balloons, catheters (including thermal catheters and bone tunnel catheters), bone cement injection devices, microdiscectomy tools, and other surgical tools.

[0139] The intelligent implant (or sensor assembly) may include an implantable reporting processor (IRP) integrated into the spinal cage, or an interbody spacer used during spinal fusion. The spinal cage may be inserted along any point of the patient's spine. For example, the spinal cage may be inserted to provide spinal fusion in the vertebral, thoracic, and / or cervical spine. The spinal cage may be configured to take load from adjacent vertebrae and may include an opening that can receive an (IRP). In embodiments where a spinal cage and a separate IRP cartridge are used, the physician couples the IRP with the spinal cage to form an intelligent implant. In an alternative configuration, the IRP may be integrated with the implant and may contain any of the features of the cartridge IRP described herein. The physician can then fill the spinal cage with material to retain the IRP and provide enhanced fusion between adjacent vertebrae. For example, the spinal cage may be filled with body material (e.g., blood scraps), other biological material, or other synthetics. As discussed in more detail below, the IRP can form a cartridge that can be permanently or reversibly inserted into the spinal cage. The cartridge may include an antenna, an inertial measurement unit (IMU), and / or additional sensors capable of sensing and tracking the patient's movements.

[0140] FIG. 26A shows a perspective view of an intelligent implant 101 in the form of a spinal cage including an implantable reporting processor 150. The implantable reporting processor 150 can be interfaced with a spinal cage / body spacer as shown in FIG. 26A. For example, the components can be assembled intraoperatively. The spinal cage can be provided in a variety of different shapes and sizes. As shown, the spinal cage can include a top surface 102, a bottom surface 104, an inner surface 106, and an outer surface 108. The inner surface 106 can include an opening 110 and / or the outer surface 108 can include an opening 112. The opening 110 and / or the opening 112 can allow the implantable reporting processor 150 to be inserted and secured within the spinal cage of the intelligent implant 101.

[0141] The implantable reporting processor 150 may include a housing 180 that encloses a battery, an electronic assembly, an antenna, and / or one or more sensors. The one or more sensors may include any of the sensors described herein. The housing 180 may include a cover or casing that encases and secures various components of the implantable reporting processor 150. For example, as shown in FIG. 26A, the implantable reporting processor 150 is in the form of a cartridge for insertion into a patient. The cartridge may be of any shape or size that allows it to be inserted into a spinal cage. For example, the implantable reporting processor 150 of FIG. 26A is thin and wafer-shaped to allow it to be inserted through the opening 110 or opening 112 of the spinal cage. The implantable reporting processor 150 may be generally D-shaped with a generally curved inner end 156b and a generally straight lateral end 158b. However, the implantable reporting processor 150 may be cylindrical or any other shape or size. As shown in FIGS. 26B-26C, the implantable reporting processor 150 may include a housing 180 that covers and encloses the battery and electronic assembly. In some embodiments, the implantable reporting processor 150 may include a top surface 152, a bottom surface 154, an inner surface 156a, and a side surface 158a. The implantable reporting processor 150 may include an antenna 160, which may be any of the antennas disclosed herein, such as antennas 312, 701, 1000, 1200, 1700, 1800, 1900, or 2100. In some embodiments, the antenna 160 of the implantable reporting processor 150 may have a radome that extends from the outer contour of the implantable reporting processor 150, for example, from the inner end 156b of the implantable reporting processor 150. When assembled with the spinal cage / body spacer, the radome may protrude from the outer contour of the spacer. This arrangement allows for communication even when the implantable reporting processor 150 and / or the spacer comprise metallic materials.As described in more detail herein, the implantable reporting processor 150 and / or spinal cage / body spacer can communicate with an external device, for example using Bluetooth Low Energy, to transmit collected data or receive programming and configuration data. The antenna 160 can be optimized for frequencies in the ISM and MICS bands.

[0142] As discussed in more detail below, the implantable reporting processor 150 may include one or more sensors positioned on various surfaces of the implantable reporting processor 150. As shown in Figures 26A-26C, the implantable reporting processor 150 may include at least one sensor 170. The at least one sensor 170 may be hermetically sealed and attached to or attached to a surface of the implantable reporting processor 150, such as, for example, on the top surface 152 of the implantable reporting processor 150. As shown in Figures 26A-26C, the at least one sensor 170 of the implantable reporting processor 150 may include a sensor 170a, a sensor 170b, and a sensor 170c. The sensors 170a, 170b, and 170c may be positioned in series.

[0143] At least one sensor 170 may include a strain or force sensor for detecting strain or force on the surface of the implantable reporting processor 150 as a means of detecting fusion between two adjacent vertebrae in which the spacer is positioned, as loads increase as fusion progresses.

[0144] At least one sensor 170 may include a vibration sensor that detects acoustic emissions associated with scraping / grinding of the interbody spacer against the adjacent vertebrae. As inter-fiber fusion progresses, the degree of acoustic emissions changes (most likely decreases).

[0145] The vibration sensor can be combined with an accelerometer to collect acoustic emission (vibration) measurements when the patient is engaged in a known activity, such as walking. The accelerometer can be a low power AC or DC accelerometer. The accelerometer can be hermetically sealed within the implantable reporting processor 150. The accelerometer can measure the tilt angle of the spine relative to the gravity vector, which provides a center of gravity measurement that correlates with the patient's recovery, pain level, and / or health status. The accelerometer can measure the patient's activity pattern (e.g., walking) and trigger the collection of data by the accelerometer that occurs during a target activity, such as walking.

[0146] Although the at least one sensor 170 is illustrated on a top surface of the implantable reporting processor 150, the sensor may be located on any other surface of the implantable reporting processor 150, as described below. Additionally, in other embodiments, the at least one sensor 170 may be incorporated into the spacer itself.

[0147] Additionally or alternatively, the implantable report processor 150 may include at least one sensor 172 on the bottom surface 154 of the implantable report processor 150. As shown in Figures 26A-26C, the at least one sensor 172 of the implantable report processor 150 may include a sensor 172a, a sensor 172b, and a sensor 172c. The sensors 172a, 172b, and 172c may be positioned in series.

[0148] In some configurations, the implantable report processor 150 may include at least one sensor 174 on the inner surface 156a of the implantable report processor 150. As shown in FIGS. 26A-26C, the at least one sensor 174 of the implantable report processor 150 may include a sensor 174a and a sensor 174b. However, the at least one sensor 174 may include more or fewer sensors in various configurations. In some configurations, the implantable report processor 150 may include at least one sensor 176 on the side surface 158a of the implantable report processor 150. As shown in FIGS. 26A-26C, the at least one sensor 176 of the implantable report processor 150 may include a sensor 176a and a sensor 176b. However, the at least one sensor 176 may include more or fewer sensors in various configurations. In some embodiments, the at least one sensor 170, the at least one sensor 172, the at least one sensor 174, and the at least one sensor 176 may be embedded within the material of the housing 180.

[0149] The implantable reporting processor 150 may be in the form of a cartridge that can be inserted into the spinal cage through either the opening 110 in the inner surface 106 or the opening 112 in the outer surface 108. In some embodiments, the implantable reporting processor 150 may form a positive connection with the spinal cage before the spinal cage is inserted into the patient. For example, the positive connection may be any of several mechanical connections, such as a snap fit, lock, twist, mating threads, etc. In some embodiments, the implantable reporting processor 150 may be reversibly inserted into the spinal cage. The reversible connection between the implantable reporting processor 150 and the spinal cage may provide the physician with the option to remove the cartridge once it is inserted into the patient in situations where any maintenance may need to be performed on the implantable reporting processor 150. The reversible connection may allow the implantable reporting processor 150 to be removed in cases where a battery may need to be replaced.

[0150] 27A illustrates an intelligent implant 101 including an implantable reporting processor 250 for insertion into a spinal cage of the intelligent implant 101. The implantable reporting processor 250 may include any of the features described above with respect to the implantable reporting processor 150. FIG 27A illustrates an implantable reporting processor 250 for insertion into a spinal cage including an antenna 260 that does not extend from a surface of the implantable reporting processor 250. The antenna 260 may be any of the antennas disclosed herein, such as antennas 160, 312, 701, 1000, 1200, 1700, 1800, 1900, or 2100.

[0151] Similar to the implantable reporting processor 150, the implantable reporting processor 250 may include a housing 280 that encloses the battery 290, the electronic assembly 240, the antenna 260, and the multiple sensors. Similar to the implantable reporting processor 150, the housing 280 of the implantable reporting processor 250 includes a cover or casing that encases and secures the various components of the implantable reporting processor 250. For example, as shown in FIG. 27A, the implantable reporting processor 250 is in the form of a cartridge for insertion into a patient. The implantable reporting processor 250 may be of any shape or size so that it can be inserted into FIGS. 27A-27C, and the wafer shape allows it to be inserted through the opening 110 or opening 112 of the spinal cage. However, as described above with respect to the implantable reporting processor 150, the implantable reporting processor 250 may be cylindrical or any other shape or size. 27A-27C, the implantable reporting processor 250 may include a top surface 252, a bottom surface 254, an inner surface 256a, and an outer surface 258a. The implantable reporting processor 250 may include a housing 280 that covers and encloses the antenna 260 and electronic assembly 240 at an inner end 256b of the implantable reporting processor 250, and a battery 290 at a lateral end 258b.

[0152] Similar to the implantable report processor 150, the implantable report processor 250 may include multiple sensors (e.g., ultrasonic sensors) positioned on various surfaces of the implantable report processor 250. As shown in Figures 27A-27D, the implantable report processor 250 may include at least one sensor 270 on a top surface 252 of the implantable report processor 250. As shown in Figures 27A-27C, the at least one sensor 270 of the implantable report processor 250 is composed of a sensor 270a, a sensor 270b, and a sensor 270c. The sensors 270a, 270b, 270c may be positioned in series along the top surface 252 of the implantable report processor 250.

[0153] Additionally or alternatively, the implantable report processor 250 may include at least one sensor 272 on the bottom surface 254 of the implantable report processor 250. As shown in Figures 27A-27C, the at least one sensor 272 may include a sensor 272a, a sensor 272b, and a sensor 272c. The sensors 272a, 272b, 272c may be positioned in series along the bottom surface 254 of the implantable report processor 250.

[0154] In some configurations, the implantable report processor 250 may include at least one sensor 274 on the inner surface 256a of the implantable report processor 250. As shown in FIGS. 27A-27C, the at least one sensor 274 of the implantable report processor 250 may be composed of a sensor 274a and a sensor 274b. However, the at least one sensor 274 may include more or fewer sensors in any number of configurations. In some configurations, the implantable report processor 250 may include at least one sensor 276 on the lateral surface 258a of the implantable report processor 250. As shown in FIGS. 27A-27C, the at least one sensor 276 of the implantable report processor 250 may include a sensor 276a and a sensor 276b. However, the at least one sensor 276 may include more or fewer sensors in various configurations. In some embodiments, the at least one sensor 270, the at least one sensor 272, the at least one sensor 274, and the at least one sensor 276 may be embedded within the material of the housing 280.

[0155] FIG. 28 illustrates an intelligent implant 200 comprising a spinal cage. The intelligent implant 200 may include any of the features described above with respect to the intelligent implant 101. The intelligent implant 200 may include a top surface 202, a bottom surface 204, an inner surface 206, and a side surface 208. The intelligent implant 200 includes an opening 210 for a window 220 and an opening 212 for the side surface 208. The intelligent implant 200 further includes a window 220 positioned at either the inner or outer end of the intelligent implant 200. In embodiments where the implantable reporting processor includes an antenna that does not extend from the intelligent implant 200, the window 220 may allow signals to be transmitted from the intelligent implant 200 without any interference. This is particularly the case where the housing 280 of the implantable reporting processor 250 includes a material such as metal. In embodiments where the housing 280 includes a material such as PEEK, signal transmission is not blocked and therefore an intelligent implant 101 without a window may be used.

[0156] 29A-29B show cross-sectional medial-side views of the intelligent implant 101 with either the implantable reporting processor 150 or the implantable reporting processor 250 inserted into the spinal cage. Fig. 29A shows a cross-sectional view in which the antenna 160 extends from the opening 110 in the medial surface 106. Fig. 29B shows a cross-sectional view in which the implantable reporting processor 250 does not extend entirely from both ends of the intelligent implant 101, but is contained between the medial surface 106 and the outer surface 108 of the intelligent implant 101.

[0157] 30A-30B show proximal-front views of either the implantable reporting processor 150 or the implantable reporting processor 250 inserted into the intelligent implant 101 or the intelligent implant 200. In FIG. 29B, the window 220 in the implantable reporting processor 250 allows the top and / or bottom of the antenna 260 on the inner end 256b of the implantable reporting processor 250 to be exposed. This is where the antenna 260 is positioned under the housing 280 so that the antenna 260 can transmit signals from the intelligent implant 200.

[0158] 31 shows a posterior front view of the intelligent implant 101, 200 inserted into a patient's spine 2310 during a spinal fusion procedure. The intelligent implant 101, 200 may be in the form of a spinal cage and is inserted between adjacent vertebrae 2320. The adjacent vertebrae 2320 may include a number of seating screws 2330 and rods 2340 that help secure the vertebrae 2320 in place during and after the spinal fusion.

[0159] An example of a spinal implant sensor assembly into which the intelligent implants disclosed herein may be incorporated is described in U.S. Patent Application No. 63 / 378,588, filed October 6, 2022, the disclosure of which is incorporated herein in its entirety.

[0160] III. Additional Embodiments and Terminology 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 reference by virtue of prior invention.

[0161] Although specific systems and methods are described herein with respect to hip implants, the systems and methods described herein may be applied to any joint implant or any implant in general. The systems and methods described herein are not limited to joints, but are generally applicable to body parts (such as the spine). Although certain embodiments and examples are described herein, those skilled in the art will appreciate that many aspects of the sensor assembly shown and described in this disclosure can be combined differently and / or modified to form still further embodiments or acceptable examples. All such modifications and variations are intended to be included herein within the scope of the present disclosure. A wide variety of designs and approaches are possible. No feature, structure, or step disclosed herein is essential or required.

[0162] For purposes of this disclosure, certain aspects, advantages, and novel features are described herein. Of course, not all such advantages may be achieved in accordance with any particular embodiment. Thus, for example, one skilled in the art will recognize that the present disclosure may be embodied or implemented in a manner that achieves one advantage or group of advantages as taught herein, without necessarily achieving other advantages that may be taught or suggested herein.

[0163] Moreover, while exemplary embodiments are described herein, the scope of any and all embodiments having equivalent elements, modifications, omissions, combinations (e.g., of aspects across various embodiments), adaptations and / or alterations, as would be understood by one of ordinary skill in the art based on this disclosure, is described herein. The limitations of the claims should be interpreted broadly based on the language employed in the claims, and not limited to the examples described in the specification or during the prosecution of this application, which examples should be interpreted as non-exclusive. Furthermore, the actions of the disclosed processes and methods may be modified in any manner, including reordering the actions, and / or inserting additional actions, and / or deleting actions. Accordingly, it is intended that the specification and examples be considered as exemplary only, with a true scope and spirit being indicated by the full scope of the claims and their equivalents.

[0164] As used herein, the terms "approximately," "approximately," and "substantially" refer to an amount close to the recited amount that still performs a desired function or achieves a desired result. For example, the terms "approximately," "approximately," and "substantially" can refer to an amount that is within less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the recited amount.

[0165] Conditional language used herein, such as, among others, "can," "may," "for example," and the like, unless specifically stated otherwise or understood within the context in which it is used, is generally intended to convey that some embodiments do not include certain features, elements, and / or conditions, while some embodiments do include certain features, elements, and / or conditions. Thus, such conditional language is not generally intended to imply that features, elements, blocks, and / or conditions are in any way required by one or more embodiments, or that one or more embodiments necessarily include logic, with or without author input or direction, for determining whether those features, elements, and / or conditions are included or implemented in any particular embodiment.

[0166] Although the methods disclosed herein may involve specific actions taken by a clinician, the methods may also include any third party instruction of those actions, either explicitly or implicitly. For example, an action such as releasing the sensor assembly includes commanding the release of the sensor assembly.

[0167] The various exemplary logic blocks, modules, routines, and algorithm steps described in connection with the embodiments disclosed herein may be implemented as electronic hardware, computer software, or a combination of both. To clearly illustrate this interchangeability of hardware and software, the various exemplary components, blocks, modules, and steps have been described above generally in terms of their functionality. Whether such functionality is implemented as hardware or software depends on the particular application and design constraints imposed on the overall system. The described functionality may be implemented in various ways for each particular application, and such implementation decisions should not be interpreted as causing a departure from the scope of the present disclosure.

[0168] Furthermore, various exemplary logic blocks and modules described in connection with the embodiments disclosed herein may be implemented or performed by machines, such as general purpose processor devices, digital signal processors (DSPs), application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs) or other programmable logic devices, including discrete gate or transistor logic, individual hardware components, or any combination thereof designed to perform the functions described herein. A general purpose processor device may be a microprocessor, but alternatively, the processor device may be a controller, microcontroller, or state machine, combinations thereof, and the like. A processor device may include electrical circuitry configured to process computer executable instructions. In another embodiment, a processor unit includes an FPGA or other programmable device that performs logical operations without processing computer executable instructions. A processor unit may also be implemented as a combination of computing devices, such as a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration. Although described herein primarily with respect to digital technology, a processor unit may also include primarily analog components. For example, some or all of the signal processing algorithms described herein may be implemented in analog circuitry or mixed analog and digital circuitry. The computing environment may include any type of computer system, including, but not limited to, computer systems based on a microprocessor, mainframe computer, digital signal processor, portable computing device, device controller, or computational engine within an appliance.

[0169] Elements of the methods, processes, routines, or algorithms described in connection with the embodiments disclosed herein may be embodied directly in hardware, in a software module executed by a processor device, or in a combination of the two. The software modules may reside in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, a hard disk, a removable disk, a CD-ROM, or any other form of non-transitory computer-readable storage medium. An exemplary storage medium may be coupled to the processor device such that the processor device can read information from, and write information to, the storage medium. Alternatively, the storage medium may be integral to the processor unit. The processor device and the storage medium may reside in an ASIC. The ASIC may reside in a user terminal. Alternatively, the processor device and the storage medium may reside as separate components in a user terminal.

[0170] IV. Working Examples Embodiment 1: An implantable system for a body part of a patient, said system comprising: 1. An electronic circuit comprising: At least one sensor; a processor configured to receive data acquired by the at least one sensor; a communication circuit coupled to the processor and configured to transmit the data acquired by the at least one sensor; an antenna comprising a plurality of conductive traces present on a substrate, the antenna being connected to the communications circuitry and further configured to facilitate transmission of the data.

[0171] Embodiment 2: The implantable system of embodiment 1, wherein a plurality of conductive traces are painted or printed on the substrate.

[0172] Embodiment 3: An implantable system described in any of embodiments 1 to 2, wherein the substrate comprises at least one of a liquid crystal polymer, a polyimide, or a polyamide.

[0173] Embodiment 4: An implantable system described in any of embodiments 1 to 3, wherein the plurality of conductive traces comprises a first plurality of conductive traces surrounding a second plurality of conductive traces, and the first plurality of conductive traces are connected to the second plurality of conductive traces.

[0174] Embodiment 5: The implantable system of embodiment 4, wherein a first plurality of conductive traces is disposed within a first ring, a second plurality of conductive traces is disposed within a second ring, and the first ring surrounds the second ring.

[0175] Embodiment 6: An enablement system 5, wherein the substrate is circular.

[0176] Embodiment 7: An implantable system described in any of embodiments 4 to 6, wherein the first plurality of conductive traces includes a first plurality of interconnected petals and the second plurality of conductive traces includes a second plurality of interconnected petals.

[0177] Embodiment 8: The implantable system of embodiment 7, wherein the distance between petals in at least one of the first or second plurality of interconnected petals affects the resonance of the antenna.

[0178] Embodiment 9: An implantable system described in any of embodiments 7 to 8, wherein at least some of the petals in at least one of the first or second plurality of interconnected petals have rounded corners, thereby improving resonance of the antenna in one or more frequency bands of interest.

[0179] Embodiment 10: An implantable system described in any of embodiments 7 to 9, wherein the plurality of conductive traces further comprises a stub connected to a second plurality of conductive traces.

[0180] Embodiment 11: The implantable system of embodiment 10, wherein the stub is curved.

[0181] Embodiment 12: An implantable system described in any of embodiments 10 to 11, wherein the antenna is configured to transmit and receive in a frequency band, and the length of the stub is selected to facilitate transmission and reception in the frequency band.

[0182] Embodiment 13: An implantable system described in any of embodiments 1 to 12, wherein the substrate is supported by a spacer that separates the antenna from the electronic circuitry.

[0183] Embodiment 14: The implantable system of embodiment 13, wherein the antenna further comprises an additional conductive trace supported by the spacer and connected to the conductive trace of the plurality of conductive traces.

[0184] Embodiment 15: The implantable system of embodiment 14, wherein an additional conductive trace is at least partially wrapped around the spacer.

[0185] Embodiment 16: The implantable system of embodiment 15, wherein the additional conductive trace is arranged in two sections that are at least partially wrapped around both sides of the spacer.

[0186] Embodiment 17: An implantable system described in any of embodiments 13 to 16, wherein the antenna is configured to transmit and receive in a frequency band and the height of the spacer is selected to facilitate transmission and reception in the frequency band.

[0187] Embodiment 18: An implantable system described in any of embodiments 13 to 17, further comprising a cover surrounding the antenna and the spacer.

[0188] Embodiment 19: The implantable system of embodiment 18, wherein the cover is spherical, cylindrical, or spherical with a flat top.

[0189] Embodiment 20: An implantable system described in any of embodiments 18 to 19, wherein the cover is made of a biocompatible material.

[0190] Embodiment 21: An operable system 1 in which the substrate has a first side and a second side opposite the first side, and a plurality of conductive traces are present on the first and second sides of the substrate.

[0191] Embodiment 22: An implantable system of embodiment 21, wherein the conductive traces present on a first side of the substrate are connected to the conductive traces present on a second side of the substrate using conductive vias.

[0192] Embodiment 23: An implantable system of embodiment 22, wherein the conductive vias are made from one or more biocompatible materials.

[0193] Embodiment 24: An implantable system described in any of embodiments 1 to 23, wherein the substrate comprises a first and a second substrate, and a plurality of conductive traces are present on the first and second substrates.

[0194] Embodiment 25: An implantable system described in any of embodiments 1 to 24, wherein the multiple conductive traces are made from one or more biocompatible materials.

[0195] Embodiment 26: An implantable system described in any of embodiments 1 to 25, wherein the antenna has a feed connecting the multiple conductive traces to a communication circuit.

[0196] Embodiment 27: An enablement system 26, in which the communication circuitry comprises a transceiver.

[0197] Embodiment 28: An implantable system described in any of embodiments 26 to 27, wherein the feed connects the multiple conductive traces to a ground of the electronic circuit.

[0198] Embodiment 29: The implantable system of embodiment 28, wherein the ground comprises a floating ground plane.

[0199] Embodiment 30: The implantable system of embodiment 29, further comprising a housing made of a conductive biocompatible material, the housing configured to support an electronic circuit and an antenna, and a floating ground plane connected to the housing.

[0200] Embodiment 31: The implantable system of embodiment 30, wherein the housing is at least partially made of titanium.

[0201] Embodiment 32: An implantable system described in any of embodiments 1 to 31, wherein a plurality of conductive traces are present on a first side of the substrate and a ground plane is present on a second side of the substrate opposite the first side.

[0202] Embodiment 33: An implantable system of embodiment 32, wherein the multiple conductive traces are connected to a ground plane through feeds or vias.

[0203] Embodiment 34: An implantable system described in any of embodiments 1 to 33, wherein the substrate comprises a first and a second substrate, a first plurality of conductive traces being present on the first substrate and a second plurality of conductive traces being present on the second substrate.

[0204] Embodiment 35: The implantable system of embodiment 34, wherein the first plurality of conductive traces are connected to the second plurality of conductive traces with conductive vias.

[0205] Embodiment 36: An implantable system described in any of embodiments 1 to 35, wherein the multiple conductive traces are arranged in a zigzag pattern.

[0206] Embodiment 37: An implantable system described in any of embodiments 1 to 36, wherein the antenna comprises a planar inverted-F antenna.

[0207] Embodiment 38: An implantable system described in any of embodiments 1 to 37, wherein the antenna is configured to transmit and receive in first and second distinct frequency bands.

[0208] Embodiment 39: A system described in embodiment 38, wherein the first antenna resonates at a center frequency of the first and second frequency bands.

[0209] Embodiment 40: A system described in embodiments 38 to 39, wherein the first frequency band includes a Medical Device Wireless Communication Service (MICS) band and the second frequency band includes an Industrial, Scientific, and Medical (ISM) band.

[0210] Embodiment 41: A system described in embodiments 38 to 40, wherein the communication and processing circuit is configured to transition from a first power state to a second power state in which more power is consumed in response to the first antenna receiving a command in the second frequency band.

[0211] Embodiment 42: The system described in embodiment 41, wherein the first power state includes a sleep state and the second power state includes an operating state in which the communication and processing circuit is configured to at least one of transmit or receive data.

[0212] Embodiment 43: The implantable system of embodiment 42, wherein the data is transmitted in a first frequency band.

[0213] Embodiment 44: An implantable system described in any of embodiments 42 to 43, wherein the processor is configured to cause transmission of data in a second power state rather than in the first power state.

[0214] Embodiment 45: An implantable system described in any of embodiments 1 to 44, wherein the body part includes a patient's joint, and at least one sensor is configured to monitor the range of motion of the patient's joint.

[0215] Embodiment 46: An implantable system as described in embodiment 45, wherein at least one sensor comprises at least one accelerometer or gyroscope.

[0216] Embodiment 47: An implantable system described in any of embodiments 1 to 46, wherein the body part includes a hip joint, a knee joint, a shoulder joint, an elbow joint, or a spine.

[0217] Embodiment 48: An implantable system described in any of embodiments 1 to 47, further comprising a femoral implant supporting electronic circuitry, the body part comprising a hip joint.

[0218] Embodiment 49: An implantable system described in any of embodiments 1 to 48, wherein the substrate is made of a biocompatible material such as one or more of a liquid crystal polymer, a polyimide, or a polyamide.

[0219] Embodiment 50: A kit comprising an implantable system of any of embodiments 1 to 49 and a receiver configured to communicate with a communication circuit.

[0220] Embodiment 51: An implantable system for the spine of a patient, said system comprising: 1. An electronic circuit comprising: At least one sensor; a processor configured to receive data acquired by the at least one sensor; a communication circuit coupled to the processor and configured to transmit the data acquired by the at least one sensor; an antenna comprising a plurality of conductive traces present on a substrate, the antenna being connected to the communications circuitry and further configured to facilitate transmission of the data.

[0221] Embodiment 52: An implantable system of embodiment 51, wherein a plurality of conductive traces are painted or printed on the substrate.

[0222] Embodiment 53: An implantable system described in any of embodiments 50 to 52, further comprising an interbody spacer or spinal cage supporting the electronic circuitry.

[0223] Embodiment 54: An implantable system described in any of embodiments 51 to 53, wherein the plurality of conductive traces comprises a first plurality of conductive traces surrounding a second plurality of conductive traces, and the first plurality of conductive traces are connected to the second plurality of conductive traces.

[0224] Embodiment 55: The implantable system of embodiment 54, wherein a first plurality of conductive traces are arranged within a first ring, a second plurality of conductive traces are arranged within a second ring, and the first ring surrounds the second ring.

[0225] Embodiment 56: An implantable system of embodiment 55, wherein the substrate is circular.

[0226] Embodiment 57: An implantable system described in any of embodiments 54 to 56, wherein the first plurality of conductive traces includes a first plurality of interconnected petals and the second plurality of conductive traces includes a second plurality of interconnected petals.

[0227] Embodiment 58: The implantable system of embodiment 57, wherein the distance between petals in at least one of the first or second plurality of interconnected petals affects the resonance of the antenna.

[0228] Embodiment 59: An implantable system described in any of embodiments 57 to 58, wherein at least some of the petals in at least one of the first or second plurality of interconnected petals have rounded corners, thereby improving resonance of the antenna in one or more frequency bands of interest.

[0229] Embodiment 60: An implantable system described in any of embodiments 57 to 59, wherein the plurality of conductive traces further comprises a stub connected to a second plurality of conductive traces.

[0230] Embodiment 61: An implantable system of embodiment 60, wherein the stub is curved.

[0231] Embodiment 62: An implantable system described in any of embodiments 60 to 61, wherein the antenna is configured to transmit and receive in a frequency band, and the length of the stub is selected to facilitate transmission and reception in the frequency band.

[0232] Embodiment 63: An implantable system described in any of embodiments 51 to 62, wherein the substrate is supported by a spacer that separates the antenna from the electronic circuitry.

[0233] Embodiment 64: The implantable system of embodiment 63, wherein the antenna further comprises an additional conductive trace supported by the spacer and connected to the conductive trace of the plurality of conductive traces.

[0234] Embodiment 65: The implantable system of embodiment 64, wherein an additional conductive trace is at least partially wrapped around the spacer.

[0235] Embodiment 66: The implantable system of embodiment 65, wherein the additional conductive trace is arranged in two sections that are at least partially wrapped around both sides of the spacer.

[0236] Embodiment 67: An implantable system described in any of embodiments 63 to 66, further comprising a cover surrounding the antenna and the spacer.

[0237] Embodiment 68: The implantable system of embodiment 67, wherein the cover is spherical, cylindrical, or spherical with a flat top.

[0238] Embodiment 69: An implantable system described in any of embodiments 67 to 68, wherein the cover is made of a biocompatible material.

[0239] Embodiment 70: An implantable system described in any of embodiments 51 to 69, wherein the substrate is made of a biocompatible material such as one or more of a liquid crystal polymer, a polyimide, or a polyamide.

[0240] Embodiment 71: A kit comprising an implantable system of any of embodiments 51 to 70 and a receiver configured to communicate with a communication circuit.

[0241] Embodiment 72: An implantable system for a body part of a patient, said system comprising: 1. An electronic circuit comprising: At least one sensor; a processor configured to receive data acquired by the at least one sensor; a communication circuit coupled to the processor and configured to transmit the data acquired by the at least one sensor; an antenna comprising a plurality of conductive traces present on a substrate, the antenna being connected to the communication circuitry and further configured to facilitate transmission of the data; A spacer for supporting the substrate; 11. The electro-optical element of claim 1, further comprising: an additional conductive trace supported by the spacer and connected to a conductive trace of the plurality of conductive traces.

[0242] Embodiment 73: The implantable system of embodiment 71, wherein an additional conductive trace is at least partially wrapped around the spacer.

[0243] Embodiment 74: The implantable system of embodiment 73, wherein the additional conductive trace is arranged in two sections that are at least partially wrapped around either side of the spacer.

[0244] Embodiment 75: An implantable system described in any of embodiments 72 to 74, wherein the antenna is configured to transmit and receive in a frequency band and the height of the spacer is selected to facilitate transmission and reception in the frequency band.

[0245] Embodiment 76: An implantable system described in any of embodiments 72 to 75, further comprising a cover surrounding the antenna and the spacer.

[0246] Embodiment 77: The implantable system of embodiment 76, wherein the cover is spherical, cylindrical, or spherical with a flat top.

[0247] Embodiment 78: An implantable system described in any of embodiments 76 to 77, wherein the cover is made of a biocompatible material.

[0248] Embodiment 79: An implantable system described in any of embodiments 72 to 78, wherein a spacer separates the antenna from the electronic circuitry.

[0249] Embodiment 80: An implantable system described in any of embodiments 72 to 79, wherein a plurality of conductive traces are painted or printed on the substrate.

[0250] Embodiment 81: An implantable system described in any of embodiments 72 to 80, wherein the spacer is made from a biocompatible material.

[0251] Embodiment 82: An implantable system described in any of embodiments 72 to 81, wherein the plurality of conductive traces comprises a first plurality of conductive traces surrounding a second plurality of conductive traces, and the first plurality of conductive traces are connected to the second plurality of conductive traces.

[0252] Embodiment 83: The implantable system of embodiment 82, wherein a first plurality of conductive traces are arranged within a first ring, a second plurality of conductive traces are arranged within a second ring, and the first ring surrounds the second ring.

[0253] Embodiment 84: An implantable system of embodiment 83, wherein the substrate is circular.

[0254] Embodiment 85: An implantable system described in any of embodiments 82 to 84, wherein the first plurality of conductive traces includes a first plurality of interconnected petals and the second plurality of conductive traces includes a second plurality of interconnected petals.

[0255] Embodiment 86: The implantable system of embodiment 85, wherein the distance between petals in at least one of the first or second plurality of interconnected petals affects the resonance of the antenna.

[0256] Embodiment 87: An implantable system described in any of embodiments 85 to 86, wherein at least some of the petals in at least one of the first or second plurality of interconnected petals have rounded corners, thereby improving resonance of the antenna in one or more frequency bands of interest.

[0257] Embodiment 88: An implantable system described in any of embodiments 85 to 57, wherein the plurality of conductive traces further comprises a stub connected to a second plurality of conductive traces.

[0258] Embodiment 89: The implantable system of embodiment 88, wherein the stub is curved.

[0259] Embodiment 90: An implantable system described in any of embodiments 88 to 89, wherein the antenna is configured to transmit and receive in a frequency band and the length of the stub is selected to facilitate transmission and reception in the frequency band.

[0260] Embodiment 91: An implantable system described in any of embodiments 72 to 90, wherein the substrate is made of a biocompatible material such as one or more of a liquid crystal polymer, a polyimide, or a polyamide.

[0261] Embodiment 92: An implantable system described in any of embodiments 72 to 91, wherein the body part includes a hip joint, a knee joint, a shoulder joint, an elbow joint, or a spine.

[0262] Embodiment 93: An implantable system described in any of embodiments 72 to 92, further comprising a femoral implant supporting an electronic circuit, the body part comprising a hip joint.

[0263] Embodiment 94: An antenna for use in an implantable system for a body part of a patient, comprising: A substrate; a plurality of conductive traces present on the substrate, the plurality of conductive traces configured to connect the antenna to a communication circuit and facilitate the transmission of data.

[0264] Embodiment 95: The antenna of embodiment 94, further comprising an additional conductive trace positioned on the spacer supporting the substrate, the additional conductive trace being connected to a conductive trace of the plurality of conductive traces.

[0265] Embodiment 96: The antenna of embodiment 95, wherein an additional conductive trace is at least partially wrapped around the spacer.

[0266] Embodiment 97: The antenna of embodiment 96, wherein an additional conductive trace is arranged in two sections that are at least partially wrapped around both sides of the spacer.

[0267] Embodiment 98: An antenna described in any of embodiments 95 to 97, wherein the antenna is configured to transmit and receive in a frequency band, and the height of the spacer is selected to facilitate transmission and reception in the frequency band.

[0268] Embodiment 99: An antenna described in any of embodiments 95 to 98, further comprising a cover that encapsulates the antenna and the spacer.

[0269] Embodiment 100: The antenna of embodiment 99, wherein the cover is spherical, cylindrical, or spherical with a flat top.

[0270] Embodiment 101: An antenna described in any of embodiments 99 to 100, wherein the cover is made from a biocompatible material.

[0271] Embodiment 102: An antenna described in any of embodiments 95 to 101, wherein a spacer is configured to separate the antenna from the communication circuit.

[0272] Embodiment 103: An antenna described in any of embodiments 94 to 102, wherein multiple conductive traces are painted or printed on the substrate.

[0273] Embodiment 104: An antenna described in any of embodiments 94 to 103, wherein the substrate comprises a biocompatible material.

[0274] Embodiment 105: An antenna described in embodiment 104, wherein the biocompatible material includes at least one of a liquid crystal polymer, a polyimide, or a polyamide.

[0275] Embodiment 106: An antenna described in any of embodiments 94 to 105, wherein the plurality of conductive traces includes a first plurality of conductive traces surrounding a second plurality of conductive traces, and the first plurality of conductive traces are connected to the second plurality of conductive traces.

[0276] Embodiment 107: An antenna of embodiment 106, wherein a first plurality of conductive traces are arranged within a first ring, a second plurality of conductive traces are arranged within a second ring, and the first ring surrounds the second ring.

[0277] Embodiment 108: An antenna of embodiment 107, wherein the substrate is circular.

[0278] Embodiment 109: An antenna described in any of embodiments 106 to 108, wherein the first plurality of conductive traces includes a first plurality of interconnected petals and the second plurality of conductive traces includes a second plurality of interconnected petals.

[0279] Embodiment 110: The antenna of embodiment 109, wherein the distance between petals in at least one of the first or second plurality of interconnected petals affects the resonance of the antenna.

[0280] Embodiment 111: An antenna of embodiment 110, wherein at least some of the petals in at least one of the first or second plurality of interconnected petals have rounded corners, thereby improving resonance of the antenna in one or more frequency bands of interest.

[0281] Embodiment 112: An antenna described in any of embodiments 110 to 111, wherein the plurality of conductive traces further includes a stub connected to a second plurality of conductive traces.

[0282] Embodiment 113: An antenna of embodiment 112, in which the stub is curved.

[0283] Embodiment 114: An antenna described in any of embodiments 112 to 113, wherein the antenna is configured to transmit and receive in a frequency band, and the length of the stub is selected to facilitate transmission and reception in the frequency band.

Claims

1. A transplantable system for a patient's body part, It is an electronic circuit, At least one sensor, A processor configured to receive data acquired by at least one of the sensors, A communication circuit connected to the processor and configured to transmit the data acquired by the at least one sensor, An antenna having a plurality of conductive traces present on a biocompatible substrate, wherein the antenna is connected to the communication circuit and further configured to facilitate the transmission of the data, A portable system comprising an antenna, wherein the plurality of conductive traces comprises a first plurality of conductive traces surrounding a second plurality of conductive traces, the first plurality of conductive traces are connected to the second plurality of conductive traces, the first plurality of conductive traces are arranged in a first ring, and the second plurality of conductive traces are arranged in a second ring surrounded by the first ring.

2. The implantable system according to claim 1, wherein the plurality of conductive traces are painted or printed on the biocompatible substrate.

3. The implantable system according to claim 1, wherein the biocompatible substrate comprises at least one of a liquid crystal polymer, polyimide, or polyamide.

4. The portable system according to claim 1, wherein the first plurality of conductive traces include a first plurality of interconnected petals, and the second plurality of conductive traces include a second plurality of interconnected petals.

5. The portable system according to claim 4, wherein the distance between the petals in at least one of the first or second plurality of interconnected petals affects the resonance of the antenna.

6. The portable system according to claim 4, wherein at least some of the petals in at least one of the first or second plurality of interconnected petals have rounded corners, thereby improving the resonance of the antenna in one or more frequency bands of interest.

7. The portable system according to claim 4, wherein the plurality of conductive traces further comprises stubs connected to the second plurality of conductive traces.

8. The implantable system according to claim 1, wherein the biocompatible substrate is supported by a spacer that separates the antenna from the electronic circuit.

9. The portable system according to claim 8, further comprising an additional conductive trace supported by the spacer and connected to the conductive traces of the plurality of conductive traces.

10. The portable system according to claim 8, wherein the antenna is configured to transmit and receive in a frequency band, and the height of the spacer is selected to facilitate transmission and reception in the frequency band.

11. The portable system according to claim 8, further comprising a cover surrounding the antenna and the spacer.

12. The implantable system according to claim 1, wherein the biocompatible substrate comprises a first side and a second side opposite to the first side, and the plurality of conductive traces are located on the first and second sides of the biocompatible substrate.

13. The implantable system according to claim 1, wherein the biocompatible substrate comprises a first and a second biocompatible substrate, and the plurality of conductive traces are present on the first and the second biocompatible substrate.

14. The implantable system according to claim 1, wherein the plurality of conductive traces are made from one or more biocompatible materials.

15. The portable system according to claim 1, wherein the antenna comprises a feed for connecting the plurality of conductive traces to the communication circuit.

16. The implantable system according to claim 1, wherein the plurality of conductive traces are located on a first side surface of the biocompatible substrate, and a ground plane is located on a second side surface of the biocompatible substrate opposite to the first side surface.

17. The implantable system according to claim 1, wherein the biocompatible substrate comprises a first and a second biocompatible substrate, a first plurality of conductive traces are present on the first biocompatible substrate, and a second plurality of conductive traces are present on the second biocompatible substrate.

18. The portable system according to claim 1, wherein the plurality of conductive traces are arranged in a zigzag pattern.

19. The portable system according to claim 1, wherein the antenna includes a plate-shaped inverted F antenna.

20. The portable system according to claim 1, wherein the antenna is configured to transmit and receive in a first and a second separate frequency band.

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