Patent Application
20240268756
Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference.
The present disclosure relates generally to intelligent implants associated with implantable systems such as orthopedic (e.g., joint) replacement systems, and more particularly, to intelligent implants with implantable reporting processors that sample, record, and transmit information related to the placement and integrity of an implanted system, and the health of the patient in which the system is implanted, as well as features of intelligent implants including enhanced transmitting antenna configurations and data sampling methods.
Orthopedic replacement systems, such as knee arthroplasty systems, shoulder arthroplasty systems, and hip arthroplasty systems, may be configured to replace the entirety of a knee, shoulder, or hip joint, or to replace a part of knee, shoulder, or hip. Systems intended to replace the entirety of a knee, shoulder, or hip joint are referred to as total joint replacement systems or total joint arthroplasty (TJA), while those intended to replace a part of a joint are referred to as partial joint replacement systems. In either case, these joint replacement systems include implant structures or components.
With reference to
With reference to
With reference to
Current commercial TJA systems have a long history of clinical use with implant duration regularly exceeding 10 years and with some reports supporting an 87% survivorship at 25 years. Clinicians currently monitor the progress of TJA patients post implant using a series of physical exams at 2-3 weeks, 6-8 weeks, 3 months, 6 months, 12 months, and yearly thereafter.
After the TJA has been implanted, and the patient begins to walk with the knee or hip prosthesis and move his arms or shoulder prosthesis, problems may occur and are sometimes hard to identify. Clinical exams are often limited in their ability to detect failure of the prosthesis; therefore, additional monitoring is often required such as CT scans, MRI scans or even nuclear scans. Given the continuum of care requirements over the lifetime of the implant, patients are encouraged to visit their clinician annually to review their health condition, monitor other joints, and assess the TJA implant's function. While the current standard of care affords the clinician and the healthcare system the ability to assess a patient's TJA function during the 90-day episode of care, the measurements are often subjective and lack temporal resolution to delineate small changes in functionality that could be a pre-cursor to larger mobility issues. The long-term (>1 year) follow up of TJA patients also poses a problem in that patients do not consistently see their clinicians annually. Rather, they often seek additional consultation only when there is pain or other symptoms.
Currently, there is no mechanism for reliably detecting misplacement, instability, or misalignment in the TJA without clinical visits and the hands and visual observations of an experienced health care provider. Even then, early identification of subclinical problems or conditions is either difficult or impossible since they are often too subtle to be detected on physical exam or demonstrable by radiographic studies. Furthermore, if detection were possible, corrective actions would be hampered by the fact that the specific amount of movement and/or degree of improper alignment cannot be accurately measured or quantified, making targeted, successful intervention unlikely. Existing external monitoring devices do not provide the fidelity required to detect instability since these devices are separated from the TJA by skin, muscle, and fat—each of which masks the mechanical signatures of instability and introduce anomalies such as flexure, tissue-borne acoustic noise, inconsistent sensor placement on the surface, and inconsistent location of the external sensor relative to the TJA.
In addition, a patient may experience a number of complications post-procedure. Such complications include neurological symptoms, pain, malfunction (blockage, loosening, etc.) and/or wear of the implant, movement or breakage of the implant, inflammation and/or infection. While some of these problems can be addressed with pharmaceutical products and/or further surgery, they are difficult to predict and prevent; often early identification of complications and side effects, although desirable, is difficult or impossible.
The present disclosure is directed to intelligent implants with implantable reporting processors that sample, record, and transmit information related to the placement and integrity of an implanted TJA, and the health of the patient in which the TJA is implanted, as well as intelligent implants having enhanced transmitting antenna configurations and data sampling methods.
Briefly stated, the present disclosure relates to an intelligent implant that includes a component of an implantable prosthesis and an implantable reporting processor (IRP) that is associated with the component. The IRP includes a housing having a casing and a cover coupled to the casing, an electronics assembly within the housing, and an antenna within the housing and coupled to the electronics assembly. The antenna is tuned to, and the electronics assembly is configured to enable communication through the antenna at both 2.45 GHz and 403 MHz (MICS channel). The antenna comprises a flat ribbon configured in a loop and having major surfaces. The antenna is encapsulated within the cover of the housing and is oriented such that its major surfaces are generally parallel with an inner surface of the cover to maximize the area inside of the antenna loop.
The present disclosure also relates to an implantable reporting processor (IRP) configured to be associated with, e.g., mechanically coupled to, an implantable prosthesis. The IRP includes a housing having a casing and a cover coupled to the casing, an electronics assembly within the housing, and an antenna within the housing and coupled to the electronics assembly. The antenna includes a flat ribbon configured in a loop and having major surfaces, and is oriented within the cover of the housing with its major surfaces generally perpendicular to a plane bound by the loop to maximize the area inside of antenna loop.
The present disclosure also relates to an implantable reporting processor (IRP) configured to be integrated with an implantable prosthesis having a receptacle. The IRP includes a battery configured to fit within the receptacle, an electronics assembly coupled to the battery and configured to within the receptacle, an antenna coupled to the electronics assembly and configured for placement outside the receptacle, and a cover configured for placement outside the receptacle and enclosing the antenna. The antenna includes a flat ribbon configured in a loop and having major surfaces, and is oriented within the cover of the housing with its major surfaces generally perpendicular to a plane bound by the loop to maximize the area inside of antenna loop.
The present disclosure also relates to an intelligent implant that includes a component of an implantable prosthesis and an implantable reporting processor (IRP) associated with the component. The IRP includes a plurality of sensors and a controller. The IRP is configured to conduct low-resolution sampling through one or more of the plurality of sensors during a low-resolution window, and to conduct one of a medium-resolution sampling and a high-resolution sampling through one or more of the plurality of sensors during at least one medium-resolution window. During the medium-resolution window the IRP detects a significant motion event and conducts either a high-resolution sampling or a medium-resolution sampling. For example, the IRP may determine whether high resolution data needs to be collected or does not need to be collected. The IRP conducts high-resolution sampling in response to a determination that high resolution data needs to be collected, and conducts a medium-resolution sampling in response to a determination that high resolution data does not need to be collected. In another example, the IRP conducts either a high-resolution sampling or a medium-resolution sampling depending on whether the detected significant motion event is a specified detection or an unspecified detection. For example, a specified detection may be an initial detection of a significant motion event, and an unspecified detection may be a subsequent detection of a significant motion event after the initial detection. The IRP conducts high-resolution sampling in response to a specified detection of a significant motion event, and conducts a medium-resolution sampling in response to an unspecified detection of a significant motion event.
The present disclosure also relates to a method of sampling data from an implantable reporting processor (IRP) of an intelligent implant implanted in a patient. The IRP is configured to sample data in each of a low-resolution mode, a medium-resolution mode, and a high-resolution mode. The method includes conducting a low-resolution sampling during a low-resolution window, and conducting one of a medium-resolution sampling and a high-resolution sampling during at least one medium-resolution window. Conducting one of a medium-resolution sampling and a high-resolution sampling includes detecting a significant motion event, which may be either a specified detection or an unspecified detection. For example, a specified detection may be an initial detection of a significant motion event, and an unspecified detection may be a subsequent detection of a significant motion event after the initial detection. The method includes conducting a high-resolution sampling in response to a specified detection of a significant motion event, and conducting a medium-resolution sampling in response to an unspecified detection of a significant motion event.
The present disclosure also relates to an electronics assembly coupled to a battery of an implantable reporting processor associated with a component of an implantable prosthesis. The electronics assembly includes an inertial measurement unit (IMU) having a number of sensors, a discrete accelerometer that functions independent of the IMU, and a controller coupled to the IMU and the discrete accelerometer. The IMU has a plurality of accelerometers, a plurality of gyroscopes, a first measurement axis for which measurements are obtained by a first accelerometer and a first gyroscope, a second measurement axis for which measurements are obtained by a second accelerometer and a second gyroscope, and a third measurement axis for which measurements are obtained by a third accelerometer and a third gyroscope. The controller is configured to, during a low-resolution window, couple the discrete accelerometer to the battery and conduct a low-resolution sampling through the discrete accelerometer, and during a medium-resolution window: a) couple the discrete accelerometer to the battery and detect for a significant event, b) responsive to a specified detection of a significant motion event, coupled the IMU to the battery and conduct a high-resolution sampling through the plurality of accelerometers and the plurality of gyroscopes, and c) responsive to an unspecified detection of the significant motion event, couple the IMU to the battery and conduct a medium-resolution sampling through the plurality of accelerometers and the plurality of gyroscopes.
This Summary has been provided to introduce certain concepts in a simplified form that are further described in detail below in the Detailed Description. Except where otherwise expressly stated, 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.
Exemplary features of the present disclosure, its nature and various advantages will be apparent from the accompanying drawings and the following detailed description of various embodiments. Non-limiting and non-exhaustive embodiments are described with reference to the accompanying drawings, wherein 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 various elements are selected, enlarged, and positioned to improve drawing legibility. The particular shapes of the elements as drawn have been selected for ease of recognition in the drawings. One or more embodiments are described hereinafter with reference to the accompanying drawings in which:
The present disclosure may be understood more readily by reference to the following detailed description of embodiments of the disclosure and the examples of implantable medical devices with implantable reporting processors. The following description, along with the accompanying drawings, sets forth certain specific details in order to provide a thorough understanding of various disclosed embodiments. However, one skilled in the relevant art will recognize that the disclosed embodiments may be practiced in various combinations, without one or more of these specific details, or with other methods, components, devices, materials, etc. In other instances, well-known structures or components that are associated with the environment of the present disclosure, including but not limited to the communication systems and networks, have not been shown or described in order to avoid unnecessarily obscuring descriptions of the embodiments.
The present disclosure refers to orthopedic implant procedures, for example, TJA (total joint arthroplasty) which term includes reference to the surgery and associated implantable medical devices such as a TJA prosthesis. Features of methods, devices and systems of the present disclosure may be illustrated herein by reference to a specific types of prosthesis, however, the disclosure should be understood to apply to any one or more orthopedic prosthesis, including for example, a TKA (total knee arthroplasty) prosthesis, such as a TKI (total knee implant) which may also be referred to as a TKA system; a TSA (total shoulder arthroplasty) prosthesis, such as a TSI (total shoulder implant) which may also be referred to as a TSI system; and a THA (total hip arthroplasty) prosthesis, such as a THI (total hip implant) which may also be referred to as a THA system, and a spinal implant system (e.g., a spinal fusion implant such as a spinal interbody cage, rod or plate, or a spinal non-fusion implant such as an artificial disc or expandable rod).
An “implantable medical device” as used in the present disclosure, is an implantable or implanted medical device that desirably replaces or functionally supplements a subject's natural body part. As used herein, the term “intelligent implant” refers to an implantable medical device with an implantable reporting processor, and is interchangeably referred to a “smart device.” When the intelligent implant makes kinematic measurements, it may be referred to as a “kinematic implantable device.” In describing embodiments of the present disclosure, reference may be made to a kinematic implantable device, however it should be understood that this is exemplary only of the intelligent medical devices which may be employed in the devices, methods, systems etc. of the present disclosure.
In one embodiment, the intelligent implant is an implanted or implantable medical device having an implantable reporting processor arranged to perform the functions as described herein. The intelligent implant may perform one or more of the following exemplary actions in order to characterize the post-implantation status of the intelligent implant: identifying the intelligent implant or a portion of the intelligent implant, e.g., by recognizing one or more unique identification codes for the intelligent implant or a portion of the intelligent implant; detecting, sensing and/or measuring parameters, which may collectively be referred to as monitoring parameters, in order to collect operational, kinematic, or other data about the intelligent implant or a portion of the intelligent implant and wherein such data may optionally be collected as a function of time; storing the collected data within the intelligent implant or a portion of the intelligent implant; and communicating the collected data and/or the stored data by a wireless means from the intelligent implant or a portion of the intelligent implant to an external computing device. The external computing device may have or otherwise have access to at least one data storage location such as found on a personal computer, a base station, a computer network, a cloud-based storage system, or another computing device that has access to such storage.
Non-limiting and non-exhaustive list of embodiments of intelligent implants include components of a total knee arthroplasty (TKA) system, a total hip arthroplasty (THA) system, a total shoulder arthroplasty (TSA) system, an intramedullary rod for arm or leg breakage repair, a scoliosis rod, a dynamic hip screw, a spinal interbody cage, a spinal rod, a spinal plate, a spinal interbody spacer, a spinal artificial disc, an annuloplasty ring, a heart valve, an intravascular stent, a vascular graft, and a vascular stent graft.
“Kinematic data,” as used herein, individually or collectively includes some or all data associated with a particular kinematic implantable device and available for communication outside of the particular kinematic implantable device. For example, kinematic data may include raw data from one or more sensors of a kinematic implantable device, wherein the one or more sensors include such as gyroscopes, accelerometers, pedometers, strain gauges, and the like that produce data associated with motion, force, tension, velocity, or other mechanical forces. Kinematic data may also include processed data from one or more sensors, status data, operational data, control data, fault data, time data, scheduled data, event data, log data, and the like associated with the particular kinematic implantable device. In some cases, high resolution kinematic data includes kinematic data from one, many, or all of the sensors of the kinematic implantable device that is collected in higher quantities, resolution, from more sensors, more frequently, or the like.
In one embodiment, kinematics refers to the measurement of the positions, angles, velocities, and accelerations of body segments and joints during motion. Body segments are considered to be rigid bodies for the purposes of describing the motion of the body. They include the foot, shank (leg), thigh, pelvis, thorax, hand, forearm, upper-arm, and head. Joints between adjacent segments include the ankle (talocrural plus subtalar joints), knee, hip, wrist, elbow, shoulder and spine (or portions thereof). Position describes the location of a body segment or joint in space, measured in terms of distance, e.g., in meters. A related measurement called displacement refers to the position with respect to a starting position. In two dimensions, the position is given in Cartesian co-ordinates, with horizontal followed by vertical position. In one embodiment, a kinematic implant or intelligent kinematic implants obtains kinematic data, and optionally only obtains only kinematic data.
“Sensor” refers to a device that can be utilized to do one or more of detect, measure and/or monitor one or more different aspects of a body tissue (anatomy, physiology, metabolism, and/or function) and/or one or more aspects of the orthopedic device or implant. Representative examples of sensors suitable for use within the present disclosure include, for example, fluid pressure sensors, fluid volume sensors, contact sensors, position sensors, pulse pressure sensors, blood volume sensors, blood flow sensors, chemistry 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. Within certain embodiments the sensor can be a wireless sensor, or, within other embodiments, a sensor connected to a wireless microprocessor. Within further embodiments one or more (including all) of the sensors can have a Unique Sensor Identification number (“USI”) which specifically 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 the orthopedic device or implant. In certain embodiments, the sensor is an accelerometer that can be utilized to measure in a quantitative manner, one or more different aspects of a body tissue (e.g., function) and/or one or more aspects of the orthopedic device or implant (e.g., alignment in the patient).
A wide variety of sensors (also referred to as Microelectromechanical Systems or “MEMS,” or Nanoelectromechanical Systems or “NEMS,” and BioMEMS or BioNEMS, see generally https://en.wikipedia.org/wiki/MEMS) can be utilized within the present disclosure. Representative patents and patent applications include U.S. Pat. Nos. 7,383,071, 7,450,332; 7,463,997, 7,924,267 and 8,634,928, and U.S. Publication Nos. 2010/0285082, and 2013/0215979. Representative publications include “Introduction to BioMEMS” by Albert Foch, CRC Press, 2013; “From MEMS to Bio-MEMS and Bio-NEMS: Manufacturing Techniques and Applications by Marc J. Madou, CRC Press 2011; “Bio-MEMS: Science and Engineering Perspectives, by Simona Badilescu, CRC Press 2011; “Fundamentals of BioMEMS and Medical Microdevices” by Steven S. Saliterman, SPIE—The International Society of Optical Engineering, 2006; “Bio-MEMS: Technologies and Applications”, edited by Wanjun Wang and Steven A. Soper, CRC Press, 2012; and “Inertial MEMS: Principles and Practice” by Volker Kempe, Cambridge University Press, 2011; Polla, D. L., et al., “Microdevices in Medicine,” Ann. Rev. Biomed. Eng. 2000, 02:551-576; Yun, K. S., et al., “A Surface-Tension Driven Micropump for Low-voltage and Low-Power Operations,” J. Microelectromechanical Sys., 11:5, October 2002, 454-461; Yeh, R., et al., “Single Mask, Large Force, and Large Displacement Electrostatic Linear Inchworm Motors,” J. Microelectromechanical Sys., 11:4, August 2002, 330-336; and Loh, N. C., al., “Sub-10 cm3 Interferometric Accelerometer with Nano-g Resolution,” J. Microelectromechanical Sys., 11:3, June 2002, 182-187; all of the above of which are incorporated by reference in their entirety.
The present disclosure provides intelligent implants, e.g., an implantable medical device with an implantable reporting processor (IRP). When the intelligent implant is included in a component of an implant system that replaces a joint, the intelligent implant can monitor displacement or movement of the component or implant system. The intelligent implant can also provide kinematic data that can be used to assess the mobility and health of the patient in which the system is implanted.
With reference to
In the embodiment of
In the embodiment of
In other embodiments, the intelligent implant corresponds to a femoral component of a knee implant system. The femoral component may be of the type shown in
With reference to
With reference to
The present disclosure provides implantable reporting processors (IRP) for implant systems that replace a joint. Embodiments disclosed include IRPs for knee implant systems, IRPs for shoulder implant systems, and IRPs for hip implant systems. As previously mentioned, in some embodiments the IRP is a component assembly that is manufactured independent of other components of the implant system and later assembled together with a component of an implant system. In some embodiments, the IRP is integrated with a component of the implant system during manufacture of the component.
With reference to
The housing 202 has a length L1 of about 73 millimeters (mm), and has a diameter D1 of about 14 mm at its widest cross section. In various embodiments, an implantable reporting processor 104 may have a length L1 in a range of 70 mm and 100 mm. In various embodiments, an implantable reporting processor 104 may have a diameter D1 at its widest cross-section in a range of 5 mm and 30 mm. It should be noted that the term diameter is used in a broad sense to refer to a maximum cross-sectional distance, where that cross-section need not be an exact circle, but may be other shapes such as oval, elliptical, or even 4-, 5- or 6-sided.
The cover 210 covers and protects the antenna 208, which allows the implantable reporting processor 104 to receive and transmit data/information (hereinafter “information”). The cover 210 can be made from any material, such as plastic or ceramic, which allows radio-frequency (RF) signals to propagate through the cover with acceptable levels of attenuation and other signal degradation. In some embodiments the cover 210 is comprised of polyetherether-ketone (PEEK).
The central section 212 and the upper coupling section 214, which are integral with one another, cover and protect the electronics assembly 206 and the battery 204, and can be made from any suitable material, such as metal, plastic, or ceramic. Furthermore, the central section 212 includes an alignment mark 220, which is configured to align with a corresponding alignment mark on the outside of the receptacle 112 of the tibial component shown in
The upper coupling section 214 is sized and otherwise configured to fit into the receptacle 112 of the tibial stem 110. The fit may be snug enough so that no securing mechanism (e.g., adhesive, set-screw) is needed, or the upper coupling section 214 can include a securing mechanism, such as threads, clips, and/or a set-screw (not shown) and a set-screw engagement hole, for attaching and securing the implantable reporting processor 104 to the tibial stem 110.
With reference to
In some embodiments, the battery 204 has a lithium-carbon-monofluoride (LiCFx) chemistry, a cylindrical housing or cylindrical container 506, a cathode terminal 502, and an anode terminal 504, which is a plate that surrounds the cathode terminal. LiCFx is a non-rechargeable (primary) chemistry, which is advantageous for maximizing the battery-energy storage capacity. The cathode terminal 502 makes conductive contact with an internal cathode electrode and couples to the cylindrical container using a hermetic feed-through insulating material of glass or ceramic. The use of the hermetic feed through prevents leakage of internal battery materials or reactive products to the exterior battery surface. Furthermore, the glass or ceramic feed-through material electrically insulates the cathode terminal 502 from the cylindrical container 506, which makes conductive contact with the internal anode electrode. The anode terminal 504 is welded to the cylindrical container 506. By locating the cathode terminal 502 and the anode terminal 504 on the same end of the battery 204, both terminals can be coupled to the electronics assembly 206 without having to run a lead, or other conductor, to the opposite end of the battery.
The container 506 can be formed from any suitable material, such as titanium or stainless steel, and can have any configuration suitable to limit expansion of the battery 204 as the battery heats during use. Because the battery 204 is inside of the casing 216, if the battery were to expand too much, it could crack the container 506 or the casing 216, or irritate the subject's tibia or other bodily tissue.
With its LiCFx chemistry, the battery 204 can provide, over its lifetime, about 360 milliampere-hours (mAh) at 3.7 volts (V), although one can increase this output by about 36 mAh for each 5 mm of length added to the battery (similarly, one can decrease this output by about 36 mAh for each 5 mm of length subtracted from the battery). It is understood that other battery chemistries can be used if they can achieve the appropriate power requirements for a given application subject to the size and longevity requirements of the application. Some additional potential battery chemistries include, but are not limited to, Lithium ion (Li-ion), Lithium Manganese dioxide (Li—MnO2), silver vanadium oxide (SVO), Lithium Thionyl Chloride (Li—SOCl2), Lithium iodine, and hybrid types consisting of combinations of the above chemistries such as CFx-SVO.
The electronics assembly 206 includes a circuit assembly 207 that has one or more sensors and a processor configured to receive and process information from the sensors relating to the state and functioning of the implantable reporting processor 104 and the state of the patient within which the implantable reporting processor is implanted. The electronics assembly 206 is further configured to transmit the processed information to an external device through the antenna 208.
With reference to
The circuit assembly 207 is coupled physically and electrically to the antenna 208 through terminals on the antenna terminal board 808, and to the power component (e.g., battery) through terminals on the battery terminal board 812. The PCBs 802, 804 may include an Inertial Measurement Unit (IMU) integrated circuit, a Real-Time Clock (RTC) integrated circuit, a memory integrated circuit (Flash), and other circuit components on one side, and a microcontroller (MCU) integrated circuit, a radio transmitter (Radio) integrated circuit, and other circuit components on the other side. In any event, the folded circuit assembly 207 provides a compact configuration that conserves a significant amount of physical space in the implantable reporting processor.
With reference to
With reference to
Thus, disclosed is an implantable reporting processor 104 wherein all active electronics and the battery 204 are contained within a hermetic assembly 136. The ground reference potential of the battery 204 is physically welded to the lower shroud 606 and the casing 216. By virtue of the intimate contact between the casing 216 and the tibial plate 106 with surrounding tissue, the implantable reporting processor 104 ground reference potential is equal to the body tissue potential (electrically neutral with surrounding tissue). Within the hermetic assembly 136, both the battery 204 reference potential (GND) and the battery positive terminal potential (VBATT) are routed throughout the electronics assembly 206 to power the electronic components. The feedthrough 612 provides connections between the electronics inside the hermetic assembly 136 and the loop antenna 208 outside the hermetic assembly. The antenna 208 is a conductive loop formed of platinum-iridium (PtIr=90/10) ribbon with one end connected to the radio transceiver and the other end connected to the battery reference potential (GND). The loop antenna 208 provides a magnetic loop, e.g., AC signal in a conductive loop generates magnetic field. The antenna 208 is encapsulated by the cover 210 and epoxy backfill, both of which are electrically non-conductive. The antenna 208 is the only electrically active component of the implantable reporting processor 104 outside the hermetic assembly 136 and under normal operating conditions is insulated by the epoxy backfill and PEEK cover from interacting electrically with surrounding tissue.
With reference to
The housing 302 has a length L1 of about 28 millimeters (mm), and has a diameter D1 of about 14 mm at its widest cross section. In various embodiments, an implantable reporting processor 104 may have a length L1 in a range of 20 mm and 30 mm. In various embodiments, an implantable reporting processor 304 may have a diameter D1 at its widest cross-section in a range of 5 mm and 30 mm. It should be noted that the term diameter is used in a broad sense to refer to a maximum cross-sectional distance, where that cross-section need not be an exact circle, but may be other shapes such as oval, elliptical, or even 4-, 5- or 6-sided.
The cover 320 covers and protects the antenna 318, which allows the implantable reporting processor 304 to receive and transmit data/information (hereinafter “information”). The cover 320 can be made from any material, such as plastic or ceramic, which allows radio-frequency (RF) signals to propagate through the cover with acceptable levels of attenuation and other signal degradation. In some embodiments the cover 210 is comprised of polyetherether-ketone (PEEK).
The central section 324 and the upper coupling section 326, which are integral with one another, cover and protect the electronics assembly 316 and the battery 314, and can be made from any suitable material, such as metal, plastic, or ceramic. Furthermore, the central section 324 includes an alignment mark 330, which is configured to align with a corresponding alignment mark on the outside of the receptacle 312 of the tibial component shown in
The upper coupling section 326 is sized and otherwise configured to fit into the receptacle 312 of the tibial stem 310. The fit may be snug enough so that no securing mechanism (e.g., adhesive, set-screw) is needed, or the upper coupling section 326 can include a securing mechanism, such as threads, clips, and/or a set-screw (not shown) and a set-screw engagement hole, for attaching and securing the implantable reporting processor 304 to the tibial stem 310.
With reference to
The electronics assembly 316 includes a circuit assembly 317 that has one or more sensors and a processor configured to receive and process information from the sensors relating to the state and functioning of the implantable reporting processor 304 and the state of the patient within which the implantable reporting processor is implanted. The electronics assembly 316 is further configured to transmit the processed information to an external device through the antenna 318.
With reference to
The circuit assembly 317 is coupled physically and electrically to the antenna 318 through terminals on the antenna terminal board 828, and to the power component (e.g., battery) through terminals on the battery terminal board 832. The PCBs 822, 824 may include an Inertial Measurement Unit (IMU) integrated circuit, an accelerometer (ACC), a microcontroller (MCU) integrated circuit and other circuit components on one side, and a Real-Time Clock (RTC) integrated circuit, a memory integrated circuit (FRAM), a radio transmitter (MICS) integrated circuit, and other circuit components on the other side. In any event, the folded circuit assembly 317 provides a compact configuration that conserves a significant amount of physical space in the implantable reporting processor.
With reference to
The first liner 702 and a second liner 704 can be formed from any suitable material, including for example, polycarbonate. The sleeve 706 can be formed of a biocompatible metallic material. In some embodiments, the material is titanium. The flange 710 is formed of a biocompatible metallic material. In some embodiments, the material is titanium. The antenna spacer 716 is formed of a non-conductive biocompatible material. In some embodiments, the antenna spacer 716 is formed of a PEEK. The feedthrough 712 is formed of a non-conductive biocompatible material. In some embodiments, the feedthrough 712 is formed of a ceramic. The x-ray ID 708 for purposes of providing identification of the implantable reporting processor 304 independent of wireless communication.
An implantable reporting processor 304 of
With reference to
With reference to
The electronics assembly 746 includes a circuit assembly 747 that has one or more sensors and a processor configured to receive and process information from the sensors relating to the state and functioning of the implantable reporting processor 124 and the state of the patient within which the implantable reporting processor is implanted. The electronics assembly 746 is further configured to transmit the processed information to an external device through the antenna 748. The circuit assembly 747 of the electronics assembly 746 may be configured as described above with reference to
With reference to
With reference to
With reference to
The battery 780 is configured to power the electronic circuitry of the implantable reporting processor 144 over a significant portion (e.g., 1-15+ years, e.g., 10 years, or 15 years), or the entirety (e.g., 18+ years), of the anticipated lifetime of the implantable reporting processor. The battery 780 may be configured the same as described above with reference to
The electronics assembly 784 includes a circuit assembly 785 that one or more sensors and a processor configured to receive and process information from the sensors relating to the state and functioning of the implantable reporting processor 144 and the state of the patient within which the implantable reporting processor is implanted. The electronics assembly 784 is further configured to transmit the processed information to an external device through the antenna 786. The circuit assembly 785 of the electronics assembly 784 may be configured as described above with reference to
In some embodiments, during assembly the cover 788 is back-filled with an epoxy (fill and bleed ports not shown). The epoxy material encapsulates the antenna 786 within the cover 788. The epoxy material may be medical grade silicone. Encapsulating the antenna 786 increases structural rigidity of the portion of implantable reporting processor 144 extending from the receptacle 782 of the femoral component 140 and isolates the antenna from tissue and body fluid.
With reference to
The battery 413 is configured to power the electronic circuitry of the implantable reporting processor 404 over a significant portion (e.g., 1-15+ years, e.g., 10 years, or 15 years), or the entirety (e.g., 18+ years), of the anticipated lifetime of the implantable reporting processor. The battery 413 may be configured the same as described above with reference to
The electronics assembly 415 includes one or more sensors and a processor configured to receive and process information from the sensors relating to the state and functioning of the implantable reporting processor 404 and the state of the patient within which the implantable reporting processor is implanted. The electronics assembly 415 is further configured to transmit the processed information to an external device through the antenna 419. The electronics assembly 415 may be configured as described above with reference to
In some embodiments, during assembly the cover 411 is back-filled with an epoxy (fill and bleed ports not shown). The epoxy material encapsulates the antenna 419 within the cover 411. The epoxy material may be medical grade silicone. Encapsulating the antenna 419 increases structural rigidity of the portion of implantable reporting processor 404 extending from the receptacle 412 of the tibial component 400 and isolates the antenna from tissue and body fluid.
With reference to
With reference to
With continued reference to
Regarding the foregoing dimensions of the antenna 208, 318, 419, 748, 786, due to skin-effect on RF transmission it is desirable to maximize the cross-sectional surface area of the antenna to minimize RF energy loss, while simultaneously minimizing PtIr volume, to thereby minimize cost. The thickness of the flat ribbon 902 represents an approximate minimum to maintain antenna shape during assembly, and the height (h) of the flat ribbon is such to achieve necessary surface area.
With reference to implantable reporting processor 104 shown in
The orientation of the antenna 208 may also be described in terms of the antenna itself. For example, with reference to
With reference to
The foregoing disclosed arrangement, orientation, and electrical coupling of the antenna 208 of the implantable reporting processor 104 shown in
Regarding the material and surface finish of the antenna 208, 318, 419, 748, 786, in some embodiments, the antenna is formed of a material comprising platinum (Pt) with an atomic percentage in a range of 70% to 100%, and iridium (Ir) with an atomic percentage in a range of 0% to 30%. In one example configuration, the antenna 208, 318, 419, 748, 786 is formed of Pt90Ir10. Platinum and Pt—Ir alloys are selected for a combination of biocompatibility, ductility, and electrical conductivity.
In some embodiments the major surfaces 914 of the antenna 208, 318, 419, 748, 786 have a surface finish in a range of 0 micro inches and 15 micro inches maximum. In one example configuration, the surface finish is 6 micro inches maximum.
As described above, in configurations of IRPs the antenna 208, 318, 419, 748, 786 is coupled to the electronics assembly through a dielectric feedthrough, with a dielectric PEEK cover and a backfill encasing the antenna. The backfill may be silicone or a medical grade epoxy adhesive. Encasing an antenna in dielectrics, coupled with post-implant placement of the antenna in boney tissue and muscle may affect antenna performance. However, the antenna 208, 318, 419, 748, 786 design, e.g., geometry, orientation, material composition, surface finish, etc., disclosed herein in combination with circuitry of the electronics assembly 206 enables post-implant communication at both 2.45 GHz and a medical implant communications system (MICS) frequency band, e.g., 401-406 MHz, despite the surrounding presence of dielectrics and tissue.
In one configuration a loop antenna 208 having the physical properties described above with reference to
The 2.45 GHz pathway 2006 includes a 2.45 GHz matching network 2010. The 2.45 GHZ matching network 2010 is coupled to the 2.45 GHz input port of the transceiver 2012 and provides 2.45 GHz signals to a transceiver 2012. The 2.45 GHz matching network 2010 matches the antenna 208 impedance to the impedance of the 2.45 GHz input of the transceiver to enable communication of wake up signals on a 2.45 GHz channel. In some embodiments, the matching impedance is greater than 50 Ohms. In some embodiments, the matching impedance is greater than 100 Ohms. In some embodiments, the matching impedance is greater than 500 Ohms. In some embodiments, the matching impedance is in the range of 100 Ohms to 800 Ohms.
The 400 MHz signal pathway 2008 includes a 2.45 GHz notch filter 2014, a MICS matching network 2016, a SAW bandpass filter 2018, and a matching element 2020 that is coupled to the 400 MHz input and output ports of the transceiver 2012. The 2.45 GHz notch filter 2008 rejects 2.45 GHz signals from the 400 MHz pathway. The SAW bandpass filter 2018 further filters the signal to reduce out-of-band signals coming into the transceiver 2012 on the 400 MHz signal pathway 2008.
The MICS matching network 2016 includes one or more circuit components and in some embodiments is firmware tunable via a first match port and second match port of the transceiver 2012. The MICS matching network 2016, together with the matching element 2020 at the MICS input of the transceiver 2012, matches the antenna 208 impedance to the impedance of the MICS input and output to enable communication on a 400 MHz channel. In some embodiments, the matching impedance at the input of the SAW bandpass filter 2018, as set by the MICS matching network 2016, is greater than 50 Ohms. In some embodiments, the matching impedance at the input of the SAW bandpass filter 2018 is greater than 100 Ohms. In some embodiments, the matching impedance at the input of the SAW bandpass filter 2018 is in the range of 100 Ohms to 500 Ohms. In some embodiments, the matching impedance at the MICS input of the transceiver 2012, as set by the matching element 2020, is greater than 10 Ohms. In some embodiments, the matching impedance at the MICS input of the transceiver 2012 is in the range of 10 Ohms to 200 Ohms.
With reference to the block diagram of
The battery 1012 can be any suitable battery, such as a Lithium Carbon Monofluoride (LiCFx) battery, or other storage cell configured to store energy for powering the electronics assembly 1010 for an expected lifetime (e.g., 5-25+ years) of the kinematic implant.
The fuse 1014 can be any suitable fuse (e.g., permanent) or circuit breaker (e.g., resettable) configured to prevent the battery 1012, or a current flowing from the battery, from injuring the patient and damaging the battery and one or more components of the electronics assembly 1010. For example, the fuse 1014 can be configured to prevent the battery 1012 from generating enough heat to burn the patient, to damage the electronics assembly 1010, to damage the battery, or to damage structural components of the kinematic implant.
The switch 1016 is configured to couple the battery 1012 to, or to uncouple the battery from, the IMU 1022 in response to a control signal 1034 from the controller 1032. For example, the controller 1032 may be configured to generate the control signal 1034 having an open state that causes the switch 1016 to open, and, therefore, to uncouple power from the IMU 1022, during a sleep mode or other low-power mode to save power, and, therefore, to extend the life of the battery 1012. Likewise, the controller 1032 also may be configured to generate the control signal 1034 having a closed state that causes the switch 1016 to close, and therefore, to couple power to the IMU 1022, upon “awakening” from a sleep mode or otherwise exiting another low-power mode. Such a low-power mode may be for only the IMU 1022 or for the IMU and one or more other components of the implantable reporting processor 1003.
The switch 1017 is configured to couple the battery 1012 to, or to uncouple the battery from, the accelerometer 1023 in response to a control signal 1036 from the controller 1032. For example, the controller 1032 may be configured to generate the control signal 1036 having an open state that causes the switch 1017 to open, and, therefore, to uncouple power from the accelerometer 1023, during a sleep mode to save power, and, therefore, to extend the life of the battery 1012. Likewise, the controller 1032 also may be configured to generate the control signal 1036 having a closed state that causes the switch 1017 to close, and therefore, to couple power to the accelerometer 1023, upon “awakening” from a sleep mode.
The switch 1018 is configured to couple the battery 1012 to, or to uncouple the battery from, the memory circuit 1024 in response to a control signal 1038 from the controller 1032. For example, the controller 1032 may be configured to generate the control signal 1038 having an open state that causes the switch 1018 to open, and, therefore, to uncouple power from the memory circuit 1024, during a sleep mode or other low-power mode to save power, and, therefore, to extend the life of the battery 1012. Likewise, the controller 1032 also may be configured to generate the control signal 1038 having a closed state that causes the switch 1018 to close, and therefore, to couple power to the memory circuit 1024, upon “awakening” from a sleep mode or otherwise exiting another low-power mode. Such a low-power mode may be for only the memory circuit 1024 or for the memory circuit and one or more other components of the electronics assembly 1010.
The clock circuit 1020 is configured to generate a clock signal for one or more of the other components of the electronics assembly 1010, and can be configured to generate periodic commands or other signals (e.g., interrupt requests) in response to which the controller 1032 causes one or more components of the implantable circuit to enter or to exit a sleep, or other low-power, mode. In some embodiments, the clock circuit 1020 is also configured to regulate the voltage from the battery 1012, and to provide a regulate power-supply voltage to some or all of the other components of the electronics assembly 1010. In these embodiments, the clock circuit 1020 may be referred to as a clock and power management circuit.
The IMU 1022 has a frame of reference with coordinate x, y, and z axes, and can be configured to measure, or to otherwise quantify, linear acceleration that the IMU experiences along each of the x, y, and z axes, and angular velocity (or rotational motion) that the IMU experiences about each of the x, y, and z axes. Such a configuration of the IMU 1022 is at least a six-axis configuration, because the IMU 1022 measures six unique quantities, ax(g), ay(g), az(g), Ωx(dps), Ωy(dps), and Ωz(dps). Alternatively, the IMU 1022 can be configured in a nine-axis configuration, in which the IMU can use the earth magnetic field to compensate for, or to otherwise correct for, accumulated errors in ax(g), ay(g), az(g), Ωx(dps), Ωy(dps), and Ωz(dps). But in an embodiment in which the IMU measures acceleration and angular velocity over only short bursts (e.g., 0.10-100 seconds(s)), for many applications accumulated error typically can be ignored without exceeding respective error tolerances.
The IMU 1022 can include a respective analog-to-digital converter (ADC) for each of the x, y, and z accelerometers and gyroscopes. Alternatively, the IMU 1022 can include a respective sample-and-hold circuit for each of the x, y, and z accelerometers and gyroscopes, and as few as one ADC that is shared by the accelerometers and gyroscopes. Including fewer than one ADC per accelerometer and gyroscope can decrease one or both of the size and circuit density of the IMU 1022, and can reduce the power consumption of the IMU. But because the IMU 1022 includes a respective sample-and-hold circuit for each accelerometer and each gyroscope, samples of the analog signals generated by the accelerometers and the gyroscopes can be taken at the same or different sample times, at the same or different sample rates, and with the same or different output data rates (ODR).
The accelerometer 1023 is configured to monitor acceleration in a low power state. The accelerometer 1023 may be a single axis or multi-axis accelerometer, and in one embodiment is a triaxial accelerometer. In the case of a triaxial configuration, the accelerometer 1023 can include a respective ADC for each of the x, y, and z accelerometers. Alternatively, the accelerometer 1023 can include a respective sample-and-hold circuit for each of the x, y, and z accelerometers, and as few as one ADC that is shared by the accelerometers. Including fewer than one ADC per accelerometer can decrease one or both of the size and circuit density of the accelerometer 1023, and can reduce the power consumption of the accelerometer 1023. Based on acceleration signals it senses, the accelerometer 1023 can detect motion events. For example, the accelerometer can be configured to detect simple motion events, such as footsteps or shoulder swings, and to count such detections. The accelerometer can be configured to detect significant motion, such as a walking motion or arm swinging motion. The accelerometer 1023 is configured to provide a wake-up signal to the controller 1032 when significant motion is detected.
The memory circuit 1024 can be any suitable nonvolatile memory circuit, such as EEPROM or FLASH memory, and can be configured to store data written by the controller 1032, and to provide data in response to a read command from the controller.
The RF transceiver 1026 can be a conventional transceiver that is configured to allow the controller 1032 (and optionally the fuse 1014) to communicate with a base station (not shown in
The RF filter 1028 can be any suitable bandpass filter, such as a surface acoustic wave (SAW) filter or a bulk acoustic wave (BAW) filter. In some embodiment, the RF filter 1028 includes multiple filters and other circuitry to enable dual-band communication. For example, the RF filter 1028 may include a bandpass filter for communications on a MICS channel, and a notch filter for communication on a different channel, such as a 2.45 GHz as described above with reference to
The antenna 1030 can be any antenna suitable for the frequency band in which the RF transceiver 1026 generates signals for transmission by the antenna, and for the frequency band in which a base station generates signals for reception by the antenna. In some embodiments the antenna 1030 is configured as a flat ribbon loop antenna as described above with reference to
The controller 1032, which can be any suitable microcontroller or microprocessor, is configured to control the configuration and operation of one or more of the other components of the electronics assembly 1010. For example, the controller 1032 is configured to control the IMU 1022 to take measurements of movement of the implantable medical device with which the electronics assembly 1010 is associated, to quantify the quality of such measurements (e.g., is the measurement “good” or “bad”), to store measurement data generated by the IMU in the memory 1024, to generate messages that include the stored data as a payload, to packetize the messages, to provide the message packets to the RF transceiver 1026 for transmission to an external device, e.g. a base station. The controller 1032 may be configured to execute commands received from an external device via the antenna 1030, the RF filter 1028, and the RF transceiver 1026. For example, the controller 1032 can be configured to receive configuration data from a base station, and to provide the configuration data to the component of the electronics assembly 1010 to which the base station directed the configuration data. If the base station directed the configuration data to the controller 1032, then the controller is configured to configure itself in response to the configuration data. The controller 1032 may also be configured to execute data sampling by the IMU 1022 in accordance with one or more programmed sampling schedules, or in response to an on-demand data sampling command received from a base station. For example, as described later below, the implantable reporting processor 104 may be programmed to operate in accordance with a master sampling schedule and a periodic, e.g., daily, sampling schedule.
As described above in conjunction with
The IMU 1022 includes three accelerometers (not shown in
The IMU 1022 also includes three gyroscopes (not shown in
The IMU 1022 includes at least two analog-to-digital converters (ADCs) (not shown in
Each ADC (not shown in
For each digital acceleration signal and for each digital angular-velocity signal, the IMU 1022 can be configured to provide the parameter values associated with the signal. For example, the IMU 1022 can provide, for each digital acceleration signal and for each digital angular-velocity signal, the sampling rate, the dynamic range, and a time stamp indicating the time at which the first sample or the last sample was taken. The IMU 1022 can be configured to provide these parameter values in the form of a message header (the corresponding samples form the message payload) or in any other suitable form.
As described above in conjunction with
The accelerometer 1023 includes an ADC for each axis 1060, 1062, and 1064 for converting the output signal of the corresponding accelerometer into a corresponding digital acceleration signal. For example, each of the ADCs may be an 8-bit, 16-bit, or 24-bit ADC.
Each ADC may be configured to have respective parameter values that are the same as, or that are different from, the parameter values of the other ADCs. Examples of such parameters having settable values include sampling rate, dynamic range at the ADC input node(s), and output data rate (ODR). One or more of these parameters may be set to a constant value, while one or more others of these parameters may be settable dynamically (e.g., during run time). For example, the respective sampling rate of each ADC may be settable dynamically so that during one sampling period the sampling rate has one value and during another sampling period the sampling rate has another value.
For each digital acceleration signal, the accelerometer 1023 can be configured to provide the parameter values associated with the signal. For example, the accelerometer 1023 can provide, for each digital acceleration signal, the sampling rate, the dynamic range, and a time stamp indicating the time at which the first sample or the last sample was taken. The accelerometer 1023 can be configured to provide these parameter values in the form of a message header (the corresponding samples form the message payload) or in any other suitable form.
As described briefly below, and in detail in PCT Publication Nos. WO 2014/209916, WO 2016/044651, WO 2017/165717 and WO 2020/247890, the acceleration signals and angular-velocity signals provided by the IMU 1022 may be processed to determine kinematic information of the patient. For example, the signals may be processed to determine a set of gait parameters including range of motion, step count, cadence, stride, and distance traveled. In general, there are three types of three-dimensional motion that the intelligent implant can detect within and around a joint: core gait (or limb mobility in the case of a shoulder or elbow arthroplasty), macroscopic instability, and microscopic instability. Details of these types of motion are described in detail in PCT Publication Nos. WO 2017/165717 and WO 2020/247890.
The step count, distance traveled, and cadence represent measures of activity and robustness of activity. The range of motion for the tibia (ROMtibia), calculated from gyroscopic data, represents the average inclusive dynamic swing over 10-15 steps of the tibia relative to the ground in the sagittal plane. Simplistically, this can be thought of as the inclusive arc of a pendulum that is translating in the sagittal plane. The range of motion for the knee (ROMknee) represents an average of the sagittal plane dynamic inclusive angle between the hip, femur, and tibia over a stride. This calculation will use a combination of published tabular data for hip and femur position stratified for sex, age, and BMI combined with the implant's ROMtibia data. This value has the same meaning as the standard of care, clinician static, goniometer measurement taken during a physical exam. However, it represents the actual dynamic range of motion during normal weight-bearing activity as opposed to a static, full capability, range of motion assessed during the physical exam. Individual values for cadence, stride, ROMtibia, and ROMknee are average values calculated based on the data collected over a 24-hour period.
Plots of the digitized versions of the analog acceleration signals ax(g), ay(g), and az(g) that the accelerometers of an IMU 1022 of a hip prosthesis 1076 respectively generate in response to accelerations along the x-axis 1060, the y-axis 1062, and the z-axis 1064 while the patient 1070 is walking forward with a normal gait at a speed of 0.9 meters/second are similar to the plot shown in
In some embodiments, an IRP 1003 of an intelligent implant is configured to be placed in five different modes of operation. These modes include:
Deep sleep mode: This mode places the IRP 1003 is in an ultra-low power state during storage to preserve shelf life prior to implantation. In this mode only the clock and power management 1020 circuit and the RF transceiver 1026 wake-up circuitry are active. To this end and with reference to
Standby mode: This mode places the IRP 1003 into a low power state, during which the implant is ready for wireless communications with an external device.
Low-resolution mode: While in this mode, the IRP 1003 collects low resolution linear acceleration data for detecting and counting simple motion events (e.g., footsteps, shoulder swings, etc.) and detection of significant motion. In some embodiments, the low-resolution mode is characterized by activation of a first set of sensors, e.g., the discrete accelerometer 1023 or one or more accelerometers of the IMU 1022, that enable the detection of simple motion events using a sampling rate in the range of 12 Hz to 100 Hz. To this end and with reference to
When in low-resolution mode, the first set of sensors counts simple motion events and sends significant motion notifications to the controller 1032. When exiting the low-resolution mode, the IMU 1022 or discrete accelerometer 1023 reports a count of simple motion events to the controller 1032. The low-resolution mode may be entered on a scheduled time and exited on a schedule time in accordance with a sampling schedule. During low-resolution mode data is continuously collected by the first set of sensors.
Medium-resolution mode: While in this mode, the IRP 1003 collects both linear acceleration and rotational motion data. In some embodiments, the medium-resolution mode is characterized by activation of a second set of sensors, e.g., three accelerometers and three gyroscopes of an IMU 1022, that enable the detection of linear acceleration and rotational velocity using a sampling rate in the range of 12 Hz to 100 Hz. To this end and with reference to
The medium-resolution mode may be initiated when an unspecified detection of a significant motion event occurs during a configured medium-resolution window of the day, or by a manual command sent wirelessly from an external device, e.g., a base station. The medium-resolution mode may be exited after a pre-determined event related to the detected significant motion. For example, in the case of a significant motion corresponding to walking, the predetermined event may be a number of steps. In the case of a significant motion corresponding to arm swings, the predetermined event may be a number of swings. The medium-resolution mode may be exited after a failure to detect a significant motion.
High-resolution mode: While in this mode, the IRP 1003 may collect linear acceleration data, or it may collect both linear acceleration and rotational motion data. In some embodiments the high-resolution mode is characterized by activation of a third set of sensors, e.g., three accelerometers of an IMU 1022 (when collecting only acceleration data), or three accelerometers and three gyroscopes of the IMU (when collecting both acceleration and rotational motion data) that enable the detection of acceleration and rotational motion data using a sampling rate in the range of 200 Hz to 5000 Hz. To this end and with reference to
The high-resolution mode may be initiated when a specified detection of a significant motion event occurs during a configured medium-resolution window of the day, or by a manual command sent wirelessly from an external device. The high-resolution mode has a built-in time limit after which acquisition is automatically terminated.
These five modes are used to collect data passively and autonomously at varying frequencies during the life of the intelligent implant without patient involvement. The intelligent implant may start collecting data on post-operative day 2 and has the capability to store up to 30 days of data in memory. Thereafter, data is transmitted to the cloud daily. If the data cannot be transmitted due to connectivity issues with a base station and the implant has reached its memory limit, new data will overwrite the oldest data. Additionally, the base station can store up to 45 days of transmitted data if it is not able to connect to the cloud but is still able to communicate with the implant locally.
With reference to
Continuing with
At block 1704, the IRP 1003 determines if the present time is within a low-resolution window established by the daily sampling schedule. The low-resolution window may be defined by a start time and an end time. The low-resolution window may be a portion of a 24-hour period, and may have an associated duration limit. For example, the low-resolution window may be limited to a maximum duration of 18 hours.
At block 1706, if the IRP 1003 determines the present time is within a low-resolution window, the process proceeds to block 1706, where the IRP conducts low-resolution sampling using a first set of sensors. Alternatively, if the IRP 1003 determines the present time is not within a low-resolution window, the process proceeds to block 1718 where the sampling session ends.
Returning to block 1706, the IRP 1003 conducts low-resolution sampling during the low-resolution window by detecting and counting steps of the patient. The low-resolution sampling may be continuous throughout the low-resolution window. To this end, the IRP 1003 may enable a first set of sensors to provide signal samples from which steps of the patient may be detected. The first set of sensors may be an accelerometer of the IMU 1022 or a separate accelerometer 1023. The low-resolution sampling rate may be in the range of 12 Hz to 100 Hz. In some embodiments, the IRP 1003 maintains a cumulative count of the steps that have been detected during each of a plurality of portions of the low-resolution window in its memory circuit 1024. For example, the IRP 1003 may maintain a cumulative count of steps for each hour of the low-resolution window.
Continuing with
At block 1708, if the IRP 1003 determines the present time is within a medium-resolution window and medium-resolution data or high-resolution data has not already been collected, the process proceeds to block 1710, where the IRP detects for a significant motion event in addition to continued step counting. Alternatively, if the IRP 1003 determines the present time is not within a medium-resolution window or that scheduled medium-resolution data and high-resolution data has already been collected, the process returns to block 1704 where the IRP determines if the present time is still within a low-resolution window.
If the IRP 1003 determines the present time is within a medium-resolution window and medium-resolution data or high-resolution data has not already been collected, then at block 1710, the IRP 1003 detects for a significant motion event by sampling the analog signals output from a second set of sensors. In some embodiments, the second set of sensors include one or more of the accelerometers of the IMU 1022, or one or more of the gyroscopes of the IMU, or a separate accelerometer 1023. In the case of one or more of the accelerometers of the IMU 1022, the IMU samples the analog signals at the same sampling rate associated with the low-resolution mode. For example, the IMU 1022 samples the analog signals output from all of the x, y, and z accelerometers and gyroscopes in the range of 12 Hz to 100 Hz.
Continuing with block 1710, either the controller 1032 or the IMU 1022 determine whether the samples that the IMU 1022 obtained are samples of a significant motion event, such as the patient 1070 walking with the implanted knee prosthesis 1072. Alternatively, either the controller 1032 or the accelerometer 1023 determine whether the samples that the accelerometer 1023 obtained are samples of a significant motion event, such as the patient 1070 walking with the implanted knee prosthesis 1072. In a preferred embodiment, the separate accelerometer 1023 samples the analog signals and makes the determination if those samples constitute a significant motion event. For example, the accelerometer 1023 may correlate the respective samples from each of one or more of the accelerometers with corresponding benchmark samples (e.g., stored in memory circuit 1024 of
Continuing with block 1710, if the IRP 1003 does not detect a significant motion event, the process returns to block 1708 where the IRP determines if the present time is still within the present medium-resolution window and medium-resolution data or high-resolution data has not already been collected. Alternatively, if the IRP 1003 detects a significant motion event, the process proceeds to block 1712, where the IRP determines if high-resolution data still needs to be collected within the present medium-resolution window. The daily sampling schedule may specify which if any medium-resolution windows should include high-resolution mode sampling.
At block 1712, if the IRP 1003 determines that high-resolution data still needs to be collected, the process proceeds to block 1714, where the IRP conducts high-resolution sampling. Alternatively, if the IRP 1003 determines that high-resolution data does not need to be collected within the current medium-resolution window, the process proceeds to block 1716 where the IRP conducts medium-resolution sampling.
Returning to block 1714, the IRP 1003 conducts high-resolution sampling by generating and storing signals indicative of three-dimensional movement. To this end, the IRP 1003 may enable a third set of sensors of the IRP 1003 to provide respective signals. The third set of sensors may be a plurality of accelerometers of the IMU 1022, wherein the respective signals represent acceleration information of the intelligent implant and the patient. In some embodiments, three accelerometers of the IMU 1022 are activated for high-resolution sampling to provide acceleration information along three axes of the IMU. The high-resolution sampling rate may be in the range of 200 Hz to 5000 Hz. This acceleration information may be processed by the controller 1032, stored in memory 1024 for subsequent transmission, or transmitted to an external device for analysis based on that data, which may be used to identify and/or address problems associated with the implanted medical device, including incorrect placement of the device, unanticipated degradation of the device, and undesired movement of the device, such as described in PCT Publication No. WO 2020/247890, the disclosure of which is incorporated herein.
In one configuration, the daily sampling schedule limits high-resolution sampling to a predetermined number of times per day. In one configuration, the number of times per day is one. The daily sampling schedule may also set the duration of the high-resolution sampling. For example, the high-resolution sampling may occur for a duration in the range of 1 second to 10 seconds. In some embodiments the duration of a high-resolution window is 3 seconds.
Returning to block 1716, the IRP 1003 conducts medium-resolution sampling by generating and storing signals indicative of three-dimensional movement. To this end, the IRP 1003 may enable a plurality of accelerometers of the IRP and a plurality of gyroscopes of the IRP to provide respective signals. The signals from the accelerometers represent acceleration information of the intelligent implant and the patient, while the signals from the gyroscopes represent angular velocity information of the intelligent implant and the patient. In some embodiments, three accelerometers of the IMU 1022 are activated for medium-resolution sampling to provide acceleration information along three axes of the IMU 1022. In some embodiments, three gyroscopes of the IMU 1022 are activated for medium-resolution sampling to provide angular velocity information about three axes of the IMU. Collectively, the acceleration information and the angular velocity information represent kinematic information of the patient. This information may be processed by the controller 1032, stored in memory 1024 for subsequent transmission, or transmitted to an external device for processing, to determine kinematic information of the patient. For example, in the case of a knee implant or a hip implant, a set of gait parameters including range of motion, step count, cadence, stride length, walking speed, and distance traveled may be determined. In the case of a shoulder implant, a set of range of motion (ROM) parameters including abduction, flexion, horizontal adduction, internal rotation, and external rotation may be determined.
The medium-resolution sampling rate may be in the range of 12 Hz to 100 Hz. The medium-resolution sampling may be conducted a limited number of times during the medium-resolution window. In one configuration, the daily sampling schedule limits medium-resolution sampling to once per medium-resolution window. The daily sampling schedule may also set the duration of the medium-resolution sampling. For example, the medium-resolution sampling may occur for a duration in the range of 5 seconds to 30 seconds. In some embodiments the duration of a high-resolution window is 10 seconds.
In addition to the schedule periodic data sampling of
The IRP 1003 of an intelligent implant may be configured to accumulate diagnostic information, e.g., event count and duration information, that can be used toward implant longevity determination. Example diagnostic information includes a count of the number of controller 1032 reset events that have occurred during the implant lifetime, the number of seconds that the implant has been in a telemetry session during the implant lifetime, a count of the total number of sectors written in flash memory during the implant lifetime, and a count of the total number of sectors erased in flash memory during the implant lifetime. Other example diagnostic information includes the number of seconds that the implant has been in a low-resolution window during the implant lifetime, a count of the number of controller 1032 reset events that have occurred during the implant lifetime, the number of seconds that the implant has been in a medium-resolution window during the implant lifetime, and the number of seconds that the implant has been in a high-resolution window during the implant lifetime. Still other example diagnostic information includes record the number of seconds that the implant has been in medium-resolution mode due to on-demand operation during the current day, record the number of seconds that the implant has been in high-resolution mode due to on-demand operation during the current day, and record the voltage of the battery at the start of the last low-resolution window that occurred.
The following disclosure focuses on a full or partial shoulder joint replacement, particularly involving replacement of the humerus, however this disclosure more generally applies to any of the medical implants as disclosed herein. Currently, post-operative, in-hospital monitoring of shoulder replacement surgery patients is conducted through personal visits by the hospital staff and medical team, physical examination of the patient, medical monitoring (vital signs, etc.), evaluation of shoulder range of motion (ROM), physiotherapy (including early mobilization and activity), and diagnostic imaging studies and blood work as required. Once the patient is discharged from hospital, prosthesis performance and patient satisfaction is checked during periodic doctor's office visits where a thorough history, physical exam and supplemental imaging and diagnostic studies are used to monitor patient progress and identify the development of any potential complications. During such visits, the surgeon typically evaluates the range of motion of the shoulder, attempts to identify any pain that occurs during certain motions or actions, and questions the patient to determine activity levels, daily functioning, pain control, and rehabilitation progress.
Unfortunately, most of the patient's recuperative period occurs between hospital and/or office visits. It can, therefore, be very difficult to accurately measure and follow full joint range of motion (ROM can change depending on pain control, degree of anti-inflammatory medication, time of day, recent activities, and/or how the patient is feeling at the time of the examination), “real life” prosthesis performance, patient activity levels, exercise tolerance, and the effectiveness of rehabilitation efforts (physiotherapy, medications, etc.) from the day of surgery through to full recovery. For much of this information, the physician is dependent upon patient self-reporting or third party observation to obtain insight into post-operative treatment effectiveness and recovery and rehabilitation progress; in many cases this is further complicated by a patient who is uncertain what to look for, has no knowledge of what “normal/expected” post-operative recovery should be, is non-compliant, or is unable to effectively communicate their symptoms. Furthermore, identifying and tracking complications (in and out of hospital) prior to them becoming symptomatic, arising between doctor visits, or those whose presence is difficult for the patient (and/or the physician) to detect would also provide beneficial, additional information to the management of shoulder replacement patients. Currently, in all instances, neither the physician nor the patient has access to the type of “real time,” continuous, objective, prosthesis performance measurements that they might otherwise like to have.
The present disclosure provides novel shoulder replacements which overcome many of the difficulties of previous shoulder prostheses, methods for constructing and monitoring these novel shoulder replacements, and further provides other related advantages.
According to one embodiment, the sensors provide evaluation data on the range of motion (ROM) of the shoulder. Currently, ROM is usually measured clinically by the physician passively moving the shoulder joint through a full range of motion during physical examination and recording the results (degrees of flexion, extension, abduction, adduction, external and internal rotation). Motion sensors and accelerometers can be used to accurately determine the full ROM of the prosthetic shoulder joint both during physical examination and during normal daily activities between visits. Similarly, motion sensors and accelerometers can be used to accurately measure any instability (including full, partial, or subclinical dislocation) of the prosthetic shoulder joint both during physical examination and during normal daily activities between visits.
During shoulder replacement surgery, the prosthetic joint will be moved through a full range of motion and stability testing to assess prosthetic function and mobility prior to surgical closure. The accelerometers of an implant of the present disclosure can provide the surgeon with accurate, numeric, quantitative range of motion data at that time; this data can be compared to expected values to assess efficacy of the implantation surgery and can serve as a baseline value for comparison to functional values obtained post-operatively. Any abnormalities in vibration (indicative of an inadequate anchoring of the prosthesis to the surrounding bone), tilt (indicative of improper tracking and/or alignment of the shoulder joint), rotation (indicative of dislocation or subluxation), and/or range of motion (acting in conjunction with the pectoral girdle, a properly functioning shoulder joint allows for a wide range of motion at the upper limb, notably flexion, extension, abduction, adduction, external/lateral rotation, internal/medial rotation and circumduction) can be addressed at this time and allow the surgeon to make adjustments intra-operatively.
Shortly after the shoulder joint or a portion thereof (e.g., a prosthetic humerus as disclosed herein) has been replaced, and following a suitable post-operative recuperating period, the upper arm will be mobilized post-operatively, at first passively, then actively; shortly after recovering from the procedure, the patient will begin gradual movement of the shoulder joint. The accelerometers can measure the movement and tracking of the shoulder joint during movement. In addition, the accelerometers can measure the impact of the arm as the associated hand contacts various objects. As the patient continues to improve their range of motion postoperatively, the acceleration experienced at different locations in the prosthetic shoulder joint, e.g., the prosthetic humerus, can be monitored. It will be expected that as the patient heals from the surgery, activity levels will progressively increase, and movement and shoulder usage will improve and increase. The effects of exercise and various activities can be monitored by the various accelerometers and can be compared to patient's subjective experiences to determine which life activities are improving (or inhibiting) post-operative recovery and rehabilitation.
Integrating the data collected by the sensors described herein (e.g., accelerometers and gyroscopes) with simple, widely available, commercial analytical technologies such as pedometers and global positioning satellite (GPS) capability, allows further clinically important data to be collected such as, but not restricted to: patient activity levels (frequency of activity, duration, intensity), exercise tolerance (work, calories, power, training effect), range of motion (discussed elsewhere herein) and prosthesis performance under various “real world” conditions. It is difficult to overstate the value of this information in enabling better management of the patient's recovery. An attending physician (or physiotherapist, rehabilitation specialist) only observes the patient episodically during scheduled visits; the degree of patient function at the exact moment of examination can be impacted by a multitude of disparate factors such as: the presence or absence of pain, the presence or absence of inflammation, stiffness, time of day, compliance and timing of medication use (pain medications, anti-inflammatories), recent activity and exercise levels, patient strength, mental status, language barriers, the nature of their doctor-patient relations, or even the patient's ability to accurately articulate their symptoms—to name just a few. Continuous monitoring and data collection can allow the patient and the physician to monitor progress objectively by supplying objective information about patient function under numerous conditions and circumstances, to evaluate how performance has been affected by various interventions (pain control, exercise, physiotherapy, anti-inflammatory medication, rest, etc.), and to compare rehabilitation progress versus previous function and future expected function. Better therapeutic decisions and better patient compliance can be expected when both the doctor and the patient have the benefit of observing the impact of various treatment modalities on patient rehabilitation, activity, function, and overall performance.
The devices, methods, systems etc. of the present disclosure have been described broadly and generically herein. Each of the narrower species and subgeneric groupings falling within the generic disclosure also form part of the present disclosure. This includes the generic description of the devices, methods, systems etc. of the present disclosure with a proviso or negative limitation removing any subject matter from the genus, regardless of whether or not the excised material is specifically recited herein.
It is also to be understood that as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural reference unless the context clearly dictates otherwise, the term “X and/or Y” means “X” or “Y” or both “X” and “Y”, and the letter “s” following a noun designates both the plural and singular forms of that noun. In addition, where features or aspects of the present disclosure are described in terms of Markush groups, it is intended, and those skilled in the art will recognize, that the present disclosure embraces and is also thereby described in terms of any individual member and any subgroup of members of the Markush group, and Applicants reserve the right to revise the application or claims to refer specifically to any individual member or any subgroup of members of the Markush group.
It is to be understood that the terminology used herein is for the purpose of describing specific embodiments only and is not intended to be limiting. It is further to be understood that unless specifically defined herein, the terminology used herein is to be given its traditional meaning as known in the relevant art.
Reference throughout this specification to “one embodiment” or “an embodiment” and variations thereof means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural referents, i.e., one or more, unless the content and context clearly dictates otherwise. For example, the term “a sensor” refers to one or more sensors, and the term “a medical device comprising a sensor” is a reference to a medical device that includes at least one sensor. A plurality of sensors refers to more than one sensor. It should also be noted that the conjunctive terms, “and” and “or” are generally employed in the broadest sense to include “and/or” unless the content and context clearly dictates inclusivity or exclusivity as the case may be. Thus, the use of the alternative (e.g., “or”) should be understood to mean either one, both, or any combination thereof of the alternatives. In addition, the composition of “and” and “or” when recited herein as “and/or” is intended to encompass an embodiment that includes all of the associated items or ideas and one or more other alternative embodiments that include fewer than all of the associated items or ideas.
Unless the context requires otherwise, throughout the specification and claims that follow, the word “comprise” and synonyms and variants thereof such as “have” and “include,” as well as variations thereof such as “comprises” and “comprising” are to be construed in an open, inclusive sense, e.g., “including, but not limited to.” The term “consisting essentially of” limits the scope of a claim to the specified materials or steps, or to those that do not materially affect the basic and novel characteristics of the claimed invention.
Any headings used within this document are only being utilized to expedite its review by the reader, and should not be construed as limiting the disclosure, invention or claims in any manner. Thus, the headings and Abstract of the Disclosure provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.
Where a range of values is provided herein, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the disclosure, invention, or claims. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges is also encompassed within the disclosure, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the disclosure.
For example, any concentration range, percentage range, ratio range, or integer range provided herein is to be understood to include the value of any integer within the recited range and, when appropriate, fractions thereof (such as one tenth and one hundredth of an integer), unless otherwise indicated. Also, any number range recited herein relating to any physical feature, such as polymer subunits, size, or thickness, are to be understood to include any integer within the recited range, unless otherwise indicated. As used herein, the term “about” means ±20% of the indicated range, value, or structure, unless otherwise indicated.
All of the U.S. patents, U.S. patent application publications, U.S. patent applications, foreign patents, foreign patent applications and non-patent publications referred to in this specification and/or listed in the Application Data Sheet, are incorporated herein by reference, in their entirety. Such documents may be incorporated by reference for the purpose of describing and disclosing, for example, materials and methodologies described in the publications, which might 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 the present application. Nothing herein is to be construed as an admission that the inventors are not entitled to antedate any referenced publication by virtue of prior invention.
All patents, publications, scientific articles, web sites, and other documents and materials referenced or mentioned herein are indicative of the levels of skill of those skilled in the art to which the disclosure pertains, and each such referenced document and material is hereby incorporated by reference to the same extent as if it had been incorporated by reference in its entirety individually or set forth herein in its entirety. Applicants reserve the right to physically incorporate into this specification any and all materials and information from any such patents, publications, scientific articles, web sites, electronically available information, and other referenced materials or documents.
In general, in the following claims, the terms used should not be construed to limit the claims to the specific embodiments disclosed in the specification and the claims, but should be construed to include all possible embodiments along with the full scope of equivalents to which such claims are entitled. Accordingly, the claims are not limited by the disclosure.
Furthermore, the written description portion of this patent includes all claims. Furthermore, all claims, including all original claims as well as all claims from any and all priority documents, are hereby incorporated by reference in their entirety into the written description portion of the specification, and Applicants reserve the right to physically incorporate into the written description or any other portion of the application, any and all such claims. Thus, for example, under no circumstances may the patent be interpreted as allegedly not providing a written description for a claim on the assertion that the precise wording of the claim is not set forth in haec verba in written description portion of the patent.
The claims will be interpreted according to law. However, and notwithstanding the alleged or perceived ease or difficulty of interpreting any claim or portion thereof, under no circumstances may any adjustment or amendment of a claim or any portion thereof during prosecution of the application or applications leading to this patent be interpreted as having forfeited any right to any and all equivalents thereof that do not form a part of the prior art.
Other nonlimiting embodiments are within the following claims. The patent may not be interpreted to be limited to the specific examples or nonlimiting embodiments or methods specifically and/or expressly disclosed herein. Under no circumstances may the patent be interpreted to be limited by any statement made by any Examiner or any other official or employee of the Patent and Trademark Office unless such statement is specifically and without qualification or reservation expressly adopted in a responsive writing by Applicants.
As mentioned above, in the following claims, the terms used should not be construed to limit the claims to the specific embodiments disclosed in the specification and the claims, but should be construed to include all possible embodiments along with the full scope of equivalents to which such claims are entitled. For example, described embodiments with one or more omitted components or steps can be additional embodiments contemplated and covered by this application.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2022/033414 | 6/14/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63210425 | Jun 2021 | US |
