Patellar Tendonitis Detection
Disclosed herein is a joint implant including a first implant coupled to a first bone of a joint, and a second implant coupled to a second bone of the joint and contacting the first implant. The second implant can include a plurality of sensors configured to measure data and a processor operatively coupled to the plurality of sensors and adapted to receive the data from the sensors. The first implant can be a femoral implant coupled to a femur. The second implant can be a patellar implant coupled to a patella. Sensor data from the patellar implant can indicate movement between the femoral implant and the patellar implant and identify patella condition such as a patellar rotation, patellar tilt and patellar tendonitis.
This application is a continuation of U.S. patent application Ser. No. 18/108,954 filed on Feb. 13, 2023, which claims the benefit of the filing date of U.S. Provisional Patent Application No. 63/444,056 filed Feb. 8, 2023, and which claims the benefit of the filing date of U.S. Provisional Patent Application No. 63/444,045, filed Feb. 8, 2023, and which claims the benefit of the filing date of U.S. Provisional Patent Application No. 63/443,146 filed Feb. 3, 2023, and which claims the benefit of the filing date of U.S. Provisional Patent Application No. 63/483,045, filed Feb. 3, 2023, and which claims the benefit of the filing date of U.S. Provisional Patent Application No. 63/482,659, filed Feb. 1, 2023, and which claims the benefit of the filing date of U.S. Provisional Patent Application No. 63/482,656 filed Feb. 1, 2023, and which claims the benefit of the filing date of U.S. Provisional Patent Application No. 63/482,097 filed Jan. 30, 2023, and which claims the benefit of the filing date of U.S. Provisional Patent Application No. 63/482,109 filed Jan. 30, 2023, and which claims the benefit of the filing date of U.S. Provisional Patent Application No. 63/481,660 filed Jan. 26, 2023, and which claims the benefit of the filing date of U.S. Provisional Patent Application No. 63/481,053 filed Jan. 23, 2023, and which claims the benefit of the filing date of U.S. Provisional Patent Application No. 63/431,094 filed Dec. 8, 2022, and which claims the benefit of the filing date of U.S. Provisional Patent Application No. 63/423,932 filed Nov. 9, 2022, and which claims the benefit of the filing date of U.S. Provisional Patent Application No. 63/419,781 filed Oct. 27, 2022, and which claims the benefit of the filing date of U.S. Provisional Patent Application No. 63/419,522 filed Oct. 26, 2022, and which claims the benefit of the filing date of United States Provisional Patent Application No. 63,419,455 filed Oct. 26, 2022, and which claims the benefit of the filing date of U.S. Provisional Patent Application No. 63/359,384 filed Jul. 8, 2022, and which claims the benefit of the filing date of United States Provisional Patent Application No. 63/309,809 filed Feb. 14, 2022, the disclosures of all of which are hereby incorporated herein by reference in their entirety.
FIELD OF INVENTIONThe present disclosure relates to implants and methods for tracking implant performance, and particularly to joint implants and methods for tracking joint implant performance.
BACKGROUND OF THE INVENTIONMonitoring patient recovery after joint replacement surgery is critical for proper patient rehabilitation. A key component of monitoring a patient's recovery is evaluating the performance of the implant to detect implant dislocation, implant wear, implant malfunction, implant breakage, etc. For example, a tibial insert made of polyethylene (“PE”) implanted in a total knee arthroscopy (“TKA”) is susceptible to macroscopic premature failure due to excessive loading and mechanical loosening. Early identification of improper implant functioning and/or infection and inflammation at the implantation site can lead to corrective treatment solutions prior to implant failure. Data relating to postoperative range of motion and load balancing of the new TKA implants can be critical for managing recovery and identification of a proper replacement solution if necessary.
However, diagnostic techniques to evaluate implant performance are generally limited to patient feedback and imaging modalities such as X-ray fluoroscopy or magnetic resonance imaging (“MRI”). Patient feedback can be misleading in some instances. For example, gradual implant wear or dislocation, onset of infection, etc., may be imperceptible to a patient. Further, imaging modalities offer only limited insight into implant performance. For example, X-ray images will not reveal information related to the patient's range of motion or the amount of stress on the knee joint of a patient recovering from a TKA. Furthermore, the imaging modalities may provide only an instantaneous snapshot of the implant performance, and therefore fail to provide continuous real time information related to implant performance.
Patients may sometimes experience patellar tendonitis after a TKA procedures. Patellar tendonitis, often referred to as “Jumper's Knee” results in inflammation of a patient's patellar tendon. If left untreated, patellar tendonitis can lead to tears in the patellar tendon and instability in a patient's knee. After a TKA procedure, a misaligned or improperly rotated patellar implant may cause premature inflammation by applying mechanical forces to the surrounding tendons and tissue.
Therefore, there exists a need for implants and related methods for tracking implant performance and recovery parameters of a patient's joint.
BRIEF SUMMARY OF THE INVENTIONDisclosed herein are joint implants and methods for tracking joint implant performance.
In accordance with an aspect of the present disclosure a joint implant is provided. A joint implant according to this aspect, may include a first implant coupled to a first bone of a joint and a second implant coupled to a second bone of the joint. The first implant may include at least one marker. The second implant may contact the first implant. The second implant may include at least one marker reader to detect a position of the marker to identify positional data of the first implant with respect to the second implant. The second implant may include at least one load sensor to measure load data between the first and second implants. A processor may be operatively coupled to the marker reader and the load sensor. The processor may simultaneously output the positional data and the load data to an external source.
Continuing in accordance with this aspect, the marker may be a magnet and the marker reader may be a magnetic sensor. The magnetic sensor may be a Hall sensor assembly including at least one Hall sensor. The magnet may be a magnetic track disposed along a surface of the first implant. The first implant may include a first magnetic track extending along a medial side of the first implant and a second magnetic track extending along a lateral side of the first implant.
Continuing in accordance with this aspect, the second implant may include a first Hall sensor assembly on a medial side of the second implant and a second Hall sensor assembly on a lateral side of the second implant. The first Hall sensor assembly may be configured to read a magnetic flux density of the first magnetic track and the second Hall sensor assembly configured to read a magnetic flux density of the second magnetic track.
Continuing in accordance with this aspect, a central portion of the first magnetic track may be narrower than an anterior end and a posterior end of the first magnetic track. The first magnetic track may include curved magnetic lines extending across the first magnetic track.
Continuing in accordance with this aspect, the magnetic sensor may be coupled to the load sensor by a connecting element. The connecting element may be a rod configured to transmit loads from the magnetic sensor to the load sensor. The load sensor may be a strain gauge.
Continuing in accordance with this aspect, the joint may be a knee joint. The first implant may be a femoral implant and the second implant may be a tibial implant. The tibial implant may include a tibial insert and a tibial stem. The marker reader and the processor may be disposed within the tibial insert.
Continuing in accordance with this aspect, the positional data may include any of a knee flexion angle, knee varus-valgus rotation, knee internal-external rotation, knee medial-lateral translation, superior-inferior translation, anterior-posterior translation, and time derivatives thereof. The load data may include any of a medial load magnitude, lateral load magnitude, medial load center and lateral load center. The tibial insert may include any of a pH sensor, a temperature sensor and a pressure sensor operatively coupled to the processor. The tibial insert may include a spectroscopy sensor. The tibial insert may be made of polyethylene.
Continuing in accordance with this aspect, the joint implant may include an antenna to transmit the positional data and the load data to an external source. The external source may be any of a tablet, computer, smart phone, and remote workstation.
In accordance with another aspect of the present disclosure, a joint implant is provided. A joint implant according to this aspect, may include a first implant coupled to a first bone of a joint and a second implant coupled to a second bone of the joint. The first implant may include a plurality of medial markers located on a medial side of the first implant, and a plurality of lateral markers located on a lateral side of the first implant. The second implant may contact the first implant. The second implant may include at least one medial marker reader to identify a position of the medial markers and at least one lateral marker reader to identify a position of the lateral markers. The position of the medial markers and the position of the lateral markers may provide positional data of the first implant with respect to the second implant. The second implant may include a medial load sensor to measure medial load data between the first and second implants on a medial side of the joint implant, a lateral load sensor to measure lateral load data between the first and second implants on a lateral side of the joint implant. A processor may be operatively coupled to the medial marker reader, the lateral marker reader, the medial load sensor, and the lateral load sensor. The processor may simultaneously output the positional data, the medial load data, and the lateral load data to an external source.
Continuing in accordance with this aspect, a number of medial markers may be different from a number of lateral markers. The medial markers and the lateral markers may include magnets located at discrete locations on the first implant. The medial marker reader and the lateral marker reader may include a Hall sensor assembly with at least one Hall sensor. The medial load sensor and the lateral load sensor may include piezo stacks.
Continuing in accordance with this aspect, the joint implant may include a battery disposed within the second implant. The joint implant may include a charging circuit disposed within the second implant to charge the battery using power generated by the piezo stacks during loading between the first and second implants.
Continuing in accordance with this aspect, the joint may be a knee joint. The first implant may be a femoral implant and the second implant may be a tibial implant. The tibial implant may include a tibial insert and a tibial stem. The marker reader and the processor may be disposed within the tibial insert. The positional data may include any of a knee flexion angle, knee varus-valgus rotation, knee internal-external rotation, knee medial-lateral translation, anterior-posterior translation, superior-inferior translation, and time derivatives thereof.
Continuing in accordance with this aspect, the medial load data may include a medial load magnitude and a medial load center. The tibial insert may include any of a pH sensor, a temperature sensor, accelerometer, gyroscope, inertial measure unit and a pressure sensor operatively coupled to the processor. The tibial insert may include a spectroscopy sensor.
In accordance with another aspect of the present disclosure, a joint implant system is provided. A joint implant system according to this aspect, may include a first implant coupled to a first bone of a joint, a second implant coupled to a second bone of the joint, and an external sleeve configured to be removably attached to the joint. The first implant may include at least one marker. The second implant may contact the first implant. The second implant may include at least one marker reader to detect a position of the marker to identify positional data of the first implant with respect to the second implant. The second implant may include at least one load sensor to measure load data between the first and second implants. A processor may be operatively coupled to the marker reader and the load sensor. The processor may be configured to simultaneously output the positional data and the load data to an external source.
Continuing in accordance with this aspect, the joint implant system may include a battery to power the marker reader and the processor. The battery may be disposed within the second implant and including a joint implant charging coil. The external sleeve may include an external charging coil to charge the battery. The battery may be configured to be charged by ultrasonic wireless charging or optical charging.
In another aspect of the present disclosure, a method for monitoring a joint implant performance is provided. A method according to this aspect, may include the steps of providing a first implant couplable to a first bone of a joint, providing a second implant couplable to a second bone of the joint, tracking magnetic flux density magnitudes over time using a magnetic sensor, and initiating a warning when a tracked magnetic flux density magnitude is different from a predetermined value. The first implant may include at least one magnetic marker. The second implant may be configured to contact the first implant. The second implant may include at least one magnetic sensor to detect the magnetic flux density of the magnetic marker. The magnetic flux density value may be proportional to a thickness of the second implant.
In accordance with another aspect of the present disclosure, a method for monitoring a joint implant performance is provided. A method according to this aspect, may include the steps of providing a first implant couplable to a first bone of a joint, providing a second implant couplable to a second bone of the joint, tracking a rate of change of a magnetic flux density over time using a magnetic sensor, and initiating a warning when a tracked rate of change of the magnetic flux density exceeds a predetermined value. The first implant may include at least one magnetic marker. The second implant may be configured to contact the first implant. The second implant may include at least one magnetic sensor to detect the magnetic flux density of the magnetic marker. The rate of change of the magnetic flux density may be proportional to a wear rate of the second implant.
In accordance with another aspect of the present disclosure, a method of monitoring implant performance is provided. A method according to this aspect, may include the steps of providing an implant with a first sensor to detect implant temperature, a second sensor to detect a fluid pressure, and a third sensor to detect implant alkalinity, tracking and outputting implant temperature, implant pressure and implant alkalinity over time to an external source using a processor disposed within the implant, and initiating a notification when any of the implant temperature, implant pressure and implant alkalinity, or any combination thereof, exceeds a predetermined value. The implant temperature, implant pressure and implant alkalinity may be related to any of an implant failure and an implant infection. The fluid pressure may be a synovial fluid pressure.
Disclosed herein are joint implants and methods for tracking joint implant performance. The joint implant disclosed herein may include multiple components that are customized to interact with the joint anatomy. A first implant may be coupled to a femur and a second implant may be coupled to a patella. The second implant may include a processor and a plurality of sensors, which may be operatively coupled to the processor. The sensors may be able to measure data from the joint, and collect information such as the movement and alignment between the first and second implants, as well as the condition of the patella. This data may be fed to the processor, with the information indicating the extent and occurrence of conditions such as patellar rotation, patellar tilt, patellar tendonitis, etc. Furthermore, this data may be used to evaluate the overall performance of the implant, and identify any necessary adjustments to ensure optimal functioning.
In accordance with an aspect of the present disclosure, a knee joint implant comprises: a femoral implant coupled to a femur of the patient, the femoral implant including at least one marker; a patellar implant coupled to a patella of a patient, the patellar implant including: at least one marker reader to detect a position of the marker to identify positional data of the patellar implant with respect to the femoral implant, and a processor operatively coupled to the marker reader, wherein the processor outputs the positional data to an external source.
In a different aspect, the marker is a magnet and the marker reader is a magnetic sensor.
In another aspect, the magnetic sensor is a Hall sensor assembly including at least one Hall sensor.
In a different aspect, the magnet is a magnetic track disposed along a surface of the femoral implant.
In another aspect, the femoral implant includes a first magnetic track extending along a medial side of the first implant and a second magnetic track extending along a lateral side of the femoral implant.
In a further aspect, the patellar implant includes a first Hall sensor assembly on a medial side of the patellar implant and a second Hall sensor assembly on a lateral side of the patellar implant, the first Hall sensor assembly configured to read a magnetic flux density of the first magnetic track and the second Hall sensor assembly configured to read a magnetic flux density of the second magnetic track.
In yet another aspect, a central portion of the first magnetic track is narrower than an anterior end and a posterior end of the first magnetic track.
In another aspect, the first magnetic track includes curved magnetic lines extending across the first magnetic track.
In a different aspect, the magnetic sensor is coupled to a load sensor by a connecting element.
In a further aspect, the patellar implant includes any of a pH sensor, a temperature sensor and a pressure sensor operatively coupled to the processor.
In a different aspect, the patellar implant includes a transmitter to transmit the positional data and the load data to an external source.
In another aspect, the external source is any of a tablet, computer, smart phone, and remote workstation.
In a further aspect, an antenna is positioned within the patellar implant.
In a different aspect, the positional data indicates at least one of patellar shift and patellar rotation.
In accordance with another aspect of the present disclosure, a method for monitoring a patellar implant comprises: coupling a femoral implant to a femur of a joint; coupling a patellar implant to a patella; sensing sensor data with a sensor positioned in the patellar implant, the sensor data indicating a relative position of the patellar implant with reference to the femoral implant; and outputting the sensor data from a processor to an external source.
In a further aspect, the sensing step includes sensing the sensor data from at least one Hall sensor positioned in the patellar implant.
In another aspect, the sensing step further includes sensing magnetic flux density caused by at least one magnet positioned within the femoral implant.
In a different aspect, the outputting step includes gathering sensor data from the sensor, analyzing the sensor data with the processor, storing the sensor data, and emitting the sensor data to an external source.
In another aspect, storing step includes storing the sensor data within a memory system, the memory system including one of RAM, ROM, and flash.
In a different aspect, the outputting step includes outputting the sensor data to the external source via near-field communication.
In another aspect, the method further includes analyzing the sensor data with a machine learning algorithm.
In a different aspect, the analyzing step includes analyzing a first sensor data from a first point in time and comparing it to a second sensor data at a second point in time to determine a change in sensor data.
In another aspect, a change in sensor data indicates patellar tendonitis.
In accordance with another aspect of the present disclosure, a method of monitoring implant position over time comprises: coupling a femoral implant to a first bone of a joint; coupling a patellar implant to a second bone of the joint, the patellar implant including a sensor, a microcontroller, and a power source; measuring a reference movement value at a first time; measuring a secondary movement value at a second time; and comparing the reference movement value to the secondary movement value.
In another aspect, the coupling steps include coupling the femoral implant to a femur and coupling the patellar implant to a patella.
In another aspect, the measuring steps include measuring a first magnetic flux from a Hall sensor corresponding to the reference movement and measuring a second magnetic flux from the Hall sensor corresponding to the second movement.
In a further aspect, the measuring steps further include measuring first and second magnetic fluxes caused by magnets imbedded within the femoral implant.
In another aspect, the measuring steps include manipulating the joint in the same orientations at the first time and the second time, the first and second times being different.
In accordance with another aspect of the present disclosure, a method of measuring joint implant movement over time comprises: coupling a femoral implant to a first bone, the femoral implant including a magnet; coupling a patellar implant to a second bone, the patellar implant including a sensor configured to sense a magnetic flux caused by the magnet of the first implant; manipulating the joint at a first time such that the sensor registers a first magnetic flux data; repeating the manipulating step at a second time, the second time being different than the first time such that the sensor registers a second magnetic flux data; and outputting the first and second magnetic flux data from the first time and the second time to an external source.
In another aspect, the method further comprises processing the first and second magnetic flux data with a microcontroller.
In a different aspect, the method further comprises powering the microcontroller with a battery.
In yet another aspect, the method further comprises outputting the first and second magnetic flux data to the external source with Bluetooth communication.
In a different aspect, the method further comprises powering the microcontroller with an inductive coil positioned adjacent the microcontroller.
In another aspect, the powering step includes positioning an external power source adjacent the inductive coil to provide power to the inductive coil and the microcontroller via near-field communication.
In a different aspect, the method further comprises charging a battery when the external power source is positioned adjacent the inductive coil.
In another aspect, the method further comprises outputting the first and second magnetic flux data to the external source via near field communication.
In another aspect, the repeating step includes repeating identical movements of the joint.
In a further aspect, the repeating step includes repeating the manipulating movements at frequent intervals of time.
In another aspect, the sensor is a Hall sensor.
In a different aspect, the first bone is a femur and the second bone is a patella.
In another aspect, the joint is a knee joint.
In a further aspect, a change in the first and second magnetic flux data at the second time indicates patellar shift or patellar rotation.
A more complete appreciation of the subject matter of the present disclosure and the various advantages thereof can be realized by reference to the following detailed description, in which reference is made to the following accompanying drawings:
Reference will now be made in detail to the various embodiments of the present disclosure illustrated in the accompanying drawings. Wherever possible, the same or like reference numbers will be used throughout the drawings to refer to the same or like features within a different series of numbers (e.g., 100-series, 200-series, etc.). It should be noted that the drawings are in simplified form and are not drawn to precise scale. Additionally, the term “a,” as used in the specification, means “at least one.” The terminology includes the words above specifically mentioned, derivatives thereof, and words of similar import. Although at least two variations are described herein, other variations may include aspects described herein combined in any suitable manner having combinations of all or some of the aspects described.
As used herein, the terms “load” and “force” will be used interchangeably and as such, unless otherwise stated, the explicit use of either term is inclusive of the other term. Similarly, the terms “magnetic markers” and “markers” will be used interchangeably and as such, unless otherwise stated, the explicit use of either term is inclusive of the other term.
As used herein, the terms “power” and “energy” will be used interchangeably and as such, unless otherwise stated, the explicit use of either term is inclusive of the other term. Similarly, the terms “implant” and “prosthesis” will be used interchangeably and as such, unless otherwise stated, the explicit use of either term is inclusive of the other term. The term “joint implant” means a joint implant system comprising two or more implants. Similarly, the terms “energy generator” and “energy harvester” will be used interchangeably and as such, unless otherwise stated, the explicit use of either term is inclusive of the other term.
In describing preferred embodiments of the disclosure, reference will be made to directional nomenclature used in describing the human body. It is noted that this nomenclature is used only for convenience and that it is not intended to be limiting with respect to the scope of the present disclosure. As used herein, when referring to bones or other parts of the body, the term “anterior” means toward the front part of the body or the face, and the term “posterior” means toward the back of the body. The term “medial” means toward the midline of the body, and the term “lateral” means away from the midline of the body. The term “superior” means closer to the head, and the term “inferior” means more distant from the head.
Details of antenna 122 are shown in
Details of tibial insert 210 are shown in
As best shown in
Tibial insert 210 includes an infection or injury detection sensor 244. For example, the infection or injury detection can be a pH sensor configured to measured bacterial infection by measuring the alkalinity of synovial fluid to provide early detection of knee joint implant 200 related infection. A temperature and pressure sensor 246 is provided in tibial insert 210 to monitor knee joint implant 200 performance. For example, any increase in temperature and/or pressure may indicate implant-associated infection. Pressure sensor 246 is used to measure synovial fluid pressure in this embodiment. Temperature and/or pressure sensor 246 readings can provide early detection of knee joint implant 200 related infection. Thus, injury detection sensors 244 and 236 provide extended diagnostics with heuristics for first level assessment of infections or injury related to knee joint implant 200. An onboard processor 250 such as a microcontroller unit (“MCU”) is used to read sensors 244 and 236 and process results for transmission to an external source. This data can be retrieved, processed, and transferred by the MCU via antenna 222 continuously, at predefined intervals, or when certain alkalinity, pressure, and/or temperature thresholds, or any combinations thereof, are detected.
The various sensors and electronic components of tibial insert 210 are contained within an upper cover 256 and a lower cover 258 as shown in
The modular design of knee joint implant 200 provides for convenient maintenance of its components. For example, an in-office or outpatient procedure will allow a surgeon to access the tibia below the patella (an area of minimal tissue allowing for fast recovery) to access component of knee joint implant 200. The electronic components and sensors of knee joint are modular and connector-less allowing for convenient replacement of tibial insert 210 or upgrades to same without impacting the femoral implant or the tibial stem.
Graphs plotting magnetic flux density measurements 310 and knee flexion angles 312 are shown in
External sleeve 868 shown in
A tibial implant 1204 according to another embodiment of the present disclosure is shown in
A knee joint implant 1400 according to another embodiment of the present disclosure is shown in
Referring now to
Hip implant 1600 includes a charging coil 1610 located on stem 1602 as shown in
A first embodiment of a modular electronic assembly 1801 is shown in
Shoulder implant 1900 includes a battery 1914 and an electronic assembly 1912 located within cup 1904. A pH sensor 1916 is located on cup 1904 to measure alkalinity and provide early detection notice of implant related infection. An antenna 1918 located on insert 1906 is provided to transmit sensor data to an external source to monitor and transmit shoulder implant 1900 performance during patient rehabilitation and recovery. Various electronic components of electronic assembly 1912, including sensors described with reference to knee joint implants, are located in cup 1904.
The decision to replace the tibial insert can be based on a rate of wear threshold 2206 as shown in graph 2200 of
In some examples, the relevant patient information may be that the knee joint and knee joint implant are in a healthy state, or alternatively that the knee joint is in an infected state. If the knee joint is determined to not be in a healthy state, the clinician can then take steps to review the condition more closely and prepare a plan for treatment if necessary. After review, the clinician can input the state of the joint as determined by the clinician so that the confirmed diagnosis is then associated with the data provided by the joint implant. The diagnosis data combined with corresponding sensor data is then stored in the cloud and henceforth considered in the software's future determinations of the state of a joint and joint implant. In some examples, the software is adapted to adjust and further refine its parameters and/or thresholds used in determining the state of an implant upon receipt of the diagnosis data.
Magnets 8636 may be any type of magnet capable of producing a magnetic field detectable by a Hall sensor. Examples of such magnet types include neodymium, samarium-cobalt (SmCo), aluminum-nickel-cobalt (AlNiCo), and ferrite. Such magnets may be in the form of magnetic tape or individual structures as shown in
A printed circuit board 8644 is housed within shell 8638. Printed circuit board 8644 may be any board known in the art, such as a single sided, double sided, multilayered, or the like. Various electrical components attach to printed circuit board 8644. Such components include at least one Hall sensor 8646, at least one battery 8648, and at least one microcontroller 8650. Each of these components is described in detail below.
Hall sensor 8646 includes three Hall effect sensors placed on medial, superior, and lateral locations of the printed circuit board 8644. Such Hall sensors 8646 may be oriented in Cartesian coordinates or arranged in other configurations. For example, four Hall effect sensors may be implemented, with the fourth sensor being located at an inferior location on printed circuit board 8644. Hall sensor 8646 is configured to sense a magnetic flux density created by magnets 8636 and output a signal proportional to the strength of the sensed magnetic field. Such an output may be readable via serial communication. The location of Hall sensor 8646 may be optimized to indicate patella shift, patella rotation or any deviation of patellar position, which may ultimately lead to patellar tendonitis.
Microcontroller 8650 includes at least one microcontroller chip. As depicted, microcontroller 8650 includes two microcontroller chips. At least one processor (CPU), memory system 8658, and a communication interface are integrated within microcontroller 8650. The CPU is configured to execute a computer program tailored to the operation of Hall sensor 8646. As such, the CPU may be configured to gather, analyze, and output sensor data 8652. Such a program and its corresponding settings may be adjusted by an operator before, during, or after implantation. The program memory may be any type configured to store sensor data, such as RAM, ROM, flash, or the like. The communication interface, otherwise known as input/output (I/O) peripherals, is configured to receive sensor data from Hall sensor 8646 and communicate the sensor data 8652 to the processor. The data is then transmitted to an external source such as a computer or a smartphone via near-field communication (NFC), Bluetooth or other wireless communication such that an operator can analyze the data. An antenna 8656 may facilitate transmission of sensor data 8652 to the external device. Microcontroller 8650 may further include an inertial measurement unit to measure acceleration changes in and around microcontroller 8650. In alternative embodiments, microcontroller 8650 may include a first microcontroller chip including an advanced RISC machine (ARM) core and a communication system. Such a communication system may be compatible with at least one of Bluetooth and near-field communications. A second microcontroller may further be utilized. Such a second microcontroller may include any combination of cores, communication systems, and memory systems.
Battery 8648 is configured to power printed circuit board 8644 and may be any battery type known in the art. For example, battery 8648 can be solid state batteries, lithium-ion batteries, lithium carbon monofluoride batteries, lithium thionyl chloride batteries, lithium ion polymer batteries, etc.
A printed circuit board 8744 is housed within shell 8738. Printed circuit board 8744 may be similar to printed circuit board 8644, and as such may be single sided, double sided, multilayered, or the like. At least one Hall sensor 8746 and at least one microcontroller 8750 are attached to printed circuit board 8744. Unlike printed circuit board 8644, printed circuit board 8744 includes a coil 8748 that provides inductive power to the printed circuit board 8744 and its components. Such a coil 8748 may be advantageous over a battery 8648 as the coil may prolong the utility of patellar implant 8706 as a battery would otherwise deteriorate over time and lose battery-life. In this way, printed circuit board 8744 may be powered solely by an external device or in a combination of an external device and a batter. Coil 8748 may be activated using near-field communication (NFC). Accordingly, to power printed circuit board 8744, a mobile device with NFC capability is moved into range of coil 8748. Once in place, the mobile device can activate to power coil 8748, which in turn powers printed circuit board 8744. NFC technology also allows microcontroller 8750 to communicate with an external mobile device, such that the mobile device can obtain the measured sensor data 8652.
Hall sensor 8746 and microcontroller 8750 operate similarly to Hall sensor 8646 and microcontroller 8650, and thus will not be fully described for sake of brevity. Unlike microcontroller 8650, microcontroller 8750 transmits data via NFC, which requires an external mobile device with NFC capability to be within a close proximity to microcontroller 8750 such that data can be transmitted between the two devices.
Machine learning may be implemented within a mobile device to analyze the sensor data from Hall sensors 8646, 8746. As such, manual comparison of sensor data points may not be required to determine when a patient is developing patellar tendonitis. A database (not shown) of average magnetic flux densities for various leg movements may be created and stored within the mobile device. This database ideally includes information from patients of all ages, body types, and various parameters regarding the surgery that took place. The machine learning algorithm may extract data from the database and compare it to measured data from Hall sensors 8646, 8746. Based on the difference between the two data sets, the machine learning algorithm may indicate to the patient and/or an operator that knee implant 8600 is imparting improper forces on patella 8612, which may lead to patellar tendonitis. The machine learning algorithms may use classifier algorithms such as random forest or support vector algorithms to compare and contrast the data. Alternatively, other algorithm types capable of comparing and contrasting data may be utilized to determine if forces are being imparted on patella 8612.
In addition to detecting patellar tendonitis by detecting movement of patella 8612 relative to femoral component 8602, the system described herein may also be used to detect other knee abnormalities. Anterior knee pain is a common symptom after a TKA. The system described herein can be utilized to determine if the patella 8612 is tracking medially, centrally, or anteriorly within the femoral groove. If such a determination is made, a physiotherapist may direct the patient to strengthen certain muscle groups of the patient's quadriceps to balance the loads acting on the knee. This same method may ultimately determine whether a patient's quadriceps are properly activated in relation to certain knee movements. Further, the system described herein may communicate with other sensor systems or smart implants to determine various other abnormalities throughout a patient's body.
A method of using patellar implant 8606 of
Once the knee implant is implanted, sensor data 8652 can be collected to determine baseline position data. An operator may manipulate a patient's leg through various movements to ensure a variety of data points are captured and that Hall sensors 8646 sense magnetic flux from a plurality of magnets 8636. Over time, a patient may repeat the same movements under similar conditions. For example, a patient may repeat the same movements annually. At each iteration, sensor data 8652 is taken, compared to previous sensor data, and stored in memory system 8658. If microcontroller 8650 detects a change in sensor data 8652 over a period time, it may transmit sensor data 8652 to an external source via Bluetooth or other wireless communication methods to create an alert that forces may be acting on patella 8612 that could indicate patellar tendonitis is developing. Sensor data 8652 may also be used to detect a change in kinematic pathways. Rather than measuring direct forces applied to the patella 8612, sensors 8646 may be used to measure and track the kinematic position of the patella 8612 relative to the femoral implant 8602. A change in the kinematic pathways may indicate patellar tendonitis or other worsening knee conditions. Alternatively, microcontroller 8650 may transmit sensor data 8652 to an external source each time sensor data 8652 is measured, and the external source may analyze sensor data 8652 using machine learning or other algorithms to determine if the magnetic fields have shifted between femoral implant 8602 and patellar implant 8606, which could indicate patellar tendonitis.
A method of using patellar implant 8706 of
Once the knee implant is implanted, sensor data 8652 can be collected to determine baseline position data. An operator may manipulate a patient's leg through various movements to ensure a variety of data points are captured and that Hall sensors 8746 sense magnetic flux from a plurality of magnets 8636. Over time, a patient may repeat the same movements under similar conditions. For example, a patient may repeat the same leg movements annually. At each iteration, sensor data 8652 is taken, compared to previous sensor data, and stored in memory system 8658. If microcontroller 8750 detects a change in sensor data 8652 over a period of time, it may transmit sensor data 8652 to an external source via NFC communication methods to create an alert that forces may be acting on patella 8612 that could indicate patellar tendonitis is developing. Alternatively, microcontroller 8750 may transmit sensor data 8652 to an external source each time sensor data 8652 is measured, and the external source may analyze sensor data 8652 using machine learning or other algorithms to determine if the magnetic fields have shifted between femoral implant 8602 and patellar implant 8606, which could indicate patellar tendonitis.
Each component described herein may be provided in a kit. Such a kit (not shown) may include different size implant components that correspond to different patients and different TKA scenarios. For instance, an operator may select implant components from a kit that correspond to the patient's unique knee geometry. Further, additional software programs may be programmed into microcontroller 8650 such that other knee parameters, such as implant loosening or subsidence, may also be measured from various Hall sensors through the implant. Accordingly, providing a kit allows an operator flexibility to determine the best treatment option for individual patients.
While a knee joint implant, hip implant, shoulder implant and a spinal implant are disclosed above, all or any of the aspects of the present disclosure can be used with any other implant such as an intramedullary nail, a bone plate, a bone screw, an external fixation device, an interference screw, etc. Although, the present disclosure generally refers to implants, the systems and method disclosed above can be used with trials to provide real time information related to trial performance. While sensors disclosed above are generally located in the tibial implant (tibial insert) of the knee joint implant, the sensors can be located within the femoral implant in other embodiments. Sensor shape, size and configuration can be customized based on the type of implant and patient-specific needs.
Furthermore, although the invention disclosed herein has been described with reference to particular features, it is to be understood that these features are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications, including changes in the sizes of the various features described herein, may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention. In this regard, the present invention encompasses numerous additional features in addition to those specific features set forth in the paragraphs below. Moreover, the foregoing disclosure should be taken by way of illustration rather than by way of limitation as the present invention is defined in the examples of the numbered paragraphs, which describe features in accordance with various embodiments of the invention, set forth in the paragraphs below.
Claims
1. A knee joint implant comprising:
- a femoral implant coupled to a femur of a patient, the femoral implant including at least one marker;
- a patellar implant including:
- at least one marker reader to detect a position of the marker to ascertain positional data of the patellar implant with respect to the femoral implant, and
- a processor operatively coupled to the marker reader,
- wherein the processor outputs the positional data to an external source.
2. The knee joint implant of claim 1, wherein the marker is a magnet and the marker reader is a magnetic sensor.
3. The knee joint implant of claim 2, wherein the magnetic sensor is a Hall sensor assembly including at least one Hall sensor.
4. The knee joint implant of claim 3, wherein the magnet is a magnetic track disposed along a surface of the femoral implant.
5. The knee joint implant of claim 4, wherein the femoral implant includes a first magnetic track extending along a medial side of the first implant and a second magnetic track extending along a lateral side of the femoral implant.
6. The knee joint implant of claim 5, wherein the patellar implant includes a first Hall sensor assembly on a medial side of the patellar implant and a second Hall sensor assembly on a lateral side of the patellar implant, the first Hall sensor assembly configured to read a magnetic flux density of the first magnetic track and the second Hall sensor assembly configured to read a magnetic flux density of the second magnetic track.
7. The knee joint implant of claim 6, wherein a central portion of the first magnetic track is narrower than an anterior end and a posterior end of the first magnetic track.
8. The knee joint implant of claim 7, wherein the first magnetic track includes curved magnetic lines extending across the first magnetic track.
9. The knee joint implant of claim 1, wherein the patellar implant includes any of a pH sensor, a temperature sensor, a load sensor and a pressure sensor operatively coupled to the processor.
10. The knee joint implant of claim 1, wherein the patellar implant includes a transmitter to transmit the positional data to an external source.
11. The knee joint implant of claim 1, wherein the positional data indicates at least one of patellar shift and patellar rotation.
12. A method for monitoring a patellar implant, the method comprising:
- coupling any of a femoral implant to a femur of a joint and a tibial implant to a tibia of the joint;
- providing a patellar implant;
- sensing sensor data with a sensor positioned in the patellar implant, the sensor data indicating a relative position of the patellar implant with reference to the femoral implant or the tibial implant; and
- outputting the sensor data from a processor to an external source.
13. The method of claim 12, wherein the sensing step includes sensing the sensor data from at least one Hall sensor positioned in the patellar implant.
14. The method of claim 13, wherein the sensing step further includes sensing magnetic flux density caused by at least one magnet positioned within the femoral implant or the tibial implant.
15. The method of the claim 14, wherein the outputting step includes gathering sensor data from the sensor, analyzing the sensor data with the processor, storing the sensor data, and emitting the sensor data to an external source.
16. The method of claim 15, further including analyzing the sensor data with a machine learning algorithm.
17. The method of claim 15, wherein the analyzing step includes analyzing a first sensor data from a first point in time and comparing it to a second sensor data at a second point in time to determine a change in sensor data.
18. The method of claim 15, wherein a change in sensor data indicates patellar tendonitis.
19. A method of monitoring implant position over time comprising:
- coupling a femoral implant to a femur of a joint;
- providing a patellar implant, the patellar implant including a sensor, a microcontroller, and a power source;
- measuring a reference movement value at a first time indicating a movement of the patellar implant with reference to the femoral implant;
- measuring a secondary movement value at a second time indicating a movement of the patellar implant with reference to the femoral implant; and
- comparing the reference movement value to the secondary movement value.
20. The method of claim 19, wherein the measuring steps include measuring a first magnetic flux from a Hall sensor corresponding to the reference movement and measuring a second magnetic flux from the Hall sensor corresponding to the second movement.
21. The method of claim 20, wherein the measuring steps further include measuring first and second magnetic fluxes caused by magnets imbedded within the femoral implant.
22. The method of claim 20, wherein the measuring steps include manipulating the joint in the same orientations at the first time and the second time, the first and second times being different.
23. The method of claim 20, wherein a change between the first and second magnetic flux data indicates patellar shift or patellar rotation.
Type: Application
Filed: Jun 16, 2023
Publication Date: Oct 12, 2023
Inventors: Carlos O. Alva (Boynton Beach, FL), Matthias Verstraete (Chaam), Ezra S. Johnson (Reeds Spring, MT)
Application Number: 18/210,809