Spinal implant sensor assembly

Abstract

An implantable sensor assembly for use during spinal fusion. An implantable sensor assembly may include a component of an implantable prosthesis and an implantable cartridge associated with the component. The implantable cartridge may include at least one sensor capable of detecting one or more kinematic measurements associated with the patient and generating sensor data, and an antenna in electrical communication with the at least one sensor, where the antenna transmits the sensor data to a receiver at a remote location.

Description

[0001] Cross - reference to related applications

[0002] Any and all applications that identify foreign or domestic priority claims in the application data sheet filed in this application are hereby incorporated by reference. Background Art Technical Field

[0003] The present disclosure generally relates to intelligent implants associated with implantable systems such as spinal implants, and more particularly to intelligent implants having an implantable reporting processor that records and transmits information related to the placement and integrity of the implant system, as well as the health status of the patient into whom the system is implanted, and features of the intelligent implant, including enhanced transmit antenna configurations and data sampling methods.

[0004] Description of Related Technology

[0005] A spinal implant can be configured to connect two or more vertebrae of the spine. Spinal fusion can occur at any part of the spine (e.g., lumbar, cervical, thoracic). A system designed to permanently connect two or more vertebrae to eliminate movement between them is called spinal fusion, which involves techniques designed to form a bridging bone between the vertebrae as part of the healing process.

[0006] Currently, there is no mechanism to reliably detect misalignment, instability, or mal - alignment of an implant without clinical access by an experienced healthcare provider and manual and visual observation. Even so, early identification of sub - clinical problems or conditions is difficult or impossible because they are often too subtle to be detected during a physical examination or shown by radiological studies. Additionally, if detection is possible, corrective measures are hindered by the fact that specific amounts of movement and / or degrees of incorrect alignment cannot be accurately measured or quantified, making targeted and successful intervention unlikely. Existing external monitoring devices do not provide the fidelity required to detect instability because these devices are separated from the implant by skin, muscle, and fat - each of which masks the mechanical signature of instability and introduces anomalies such as bending, tissue - propagated noise, inconsistent sensor placement on the surface, and inconsistent positioning of external sensors relative to the implant.

[0007] In addition, patients may experience many complications after surgery. These complications include neurological symptoms, pain, dysfunction (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; early identification of complications and side - effects, while desirable, is often difficult or impossible.

[0008] The present disclosure relates to an intelligent implant having an implantable reporting processor that samples, records, and transmits information related to the placement and integrity of a spinal implant and the health of a patient into whom the spinal implant is implanted, and an intelligent implant having an enhanced transmission antenna configuration and data sampling method. SUMMARY OF THE INVENTION

[0009] In some aspects, an implantable sensor assembly for use during spinal fusion or other spinal surgery is disclosed. The implantable sensor assembly may include components and an implantable cannula associated with the components. The components may form part of an implantable prosthesis. The implantable cannula may include at least one sensor capable of detecting one or more kinematic measurements associated with a patient and generating sensor data. The implantable cannula may also include an antenna in electrical communication with the sensor. The antenna may transmit the sensor data to a receiver at a remote location.

[0010] The implantable sensor assembly may include one or more of the following features. The implantable cannula may include a battery. The implantable cannula may include an inertial measurement unit having a plurality of accelerometers and / or a plurality of gyroscopes. For example, the inertial measurement unit may include a first accelerometer and / or a first gyroscope for measuring data associated with a first measurement axis. The inertial measurement unit may also include a second accelerometer and / or a second gyroscope for measuring data associated with a second measurement axis. The inertial measurement unit may also include a third accelerometer and / or a third gyroscope for measuring data associated with a third measurement axis. In some configurations, the implantable cannula may have two or more different inertial measurement units for separate evaluations, such as separate motor functions. In some configurations, the implantable cannula may have one or more accelerometers and / or gyroscopes separate from the inertial measurement unit.

[0011] In some aspects, the implantable cartridge may include a certain length and a circular, oval, square, or rectangular cross-section. The implantable cartridge may have a cross-section with a corner radius associated with a square or rectangular cross-section. The implantable cartridge may interface with or be positioned within a spinal implant. In some embodiments, the spinal implant may be an interbody spacer or a spinal cage. For example, the implantable cartridge may be inserted into an opening of an interbody spacer or into a slot of a cage. The cartridge may be mechanically coupled to a component. The cartridge may be reversibly coupled to a component. The cartridge may form a one-way positive connection with the component. The cartridge may be mechanically coupled to the component using at least one of a corresponding snap ring, lock, twist, thread, or chemical adhesive. The cartridge may be press-fitted into the component. The cartridge may include a plurality of sensors positioned on the top surface of the cartridge. The cartridge may include a plurality of sensors positioned on the bottom surface of the cartridge. The cartridge may include at least one sensor positioned on the proximal surface of the cartridge. The cartridge may include at least one sensor positioned on the distal surface of the cartridge. The plurality of sensors may be positioned on the top surface of the cartridge, and the plurality of sensors positioned on the bottom surface of the cartridge measure the subsidence of the implantable sensor assembly. At least one sensor may be positioned on the proximal surface of the cartridge, and the distal surface of the cartridge provides translational and orientation-related movement of the implantable sensor assembly. The plurality of sensors may be positioned in series on the top surface of the cartridge. The plurality of sensors positioned on the bottom surface of the cartridge are in series. The cartridge may include a series of three sensors on the top surface of the cartridge, a series of three sensors on the bottom surface of the cartridge, a plurality of sensors on the proximal end of the cartridge, and a plurality of sensors on the distal end of the cartridge. An antenna may extend from the proximal or distal end of the cartridge. The antenna may be contained within a gap of the component. The antenna may be contained within a component whose material composition enables signal transmission from the antenna. The component may comprise polyetheretherketone (PEEK). The implantable sensor assembly may further include a processor. The components of the implantable prosthesis may be an interbody spacer or a cage for use during spinal fusion. The interbody spacer may be inserted into the lumbar region of the spine. The interbody spacer may be inserted into the cervical region of the spine. The interbody spacer may be inserted into the thoracic region of the spine. The cage may be a lumbar cage. The cage may be a cervical cage. The cage may be a thoracic cage. The implantable sensor may further include at least one sensor, and the at least one sensor may be an ultrasonic sensor. The ultrasonic sensor may be an M-mode sensor. The ultrasonic sensor may be a B-mode sensor. The ultrasonic sensor may be a low-power sensor. The antenna may be a loop antenna. The antenna may be a conformal antenna. The antenna may transmit sensor data continuously. The antenna may transmit sensor data intermittently. At least one sensor may continuously detect one or more physiological parameters. At least one sensor may intermittently detect one or more physiological parameters. A power source may supply power to at least one sensor. The power source may be rechargeable. At least one sensor may be powered by a power source external to the patient's body. The implantable sensor may further include a memory device for storing data from at least one sensor.The memory device may have sufficient memory to enable firmware upgrades of the sensor components.

[0012] In some aspects, a spinal implant assembly for use during spinal fusion or other spinal surgery is disclosed. The barrel may be mechanically coupled to an interbody spacer or spinal cage. The barrel may include at least one sensor and an antenna. The sensor, which is capable of detecting one or more physiological parameters of a patient and generating sensor data; the antenna may be in electrical communication with at least one sensor and provide two-way data communication to a receiver at a remote location. The barrel may be inserted into a mating cavity within the interbody spacer or spinal cage.

[0013] The spinal implant assembly may include one or more of the following features. The spinal implant assembly may include a battery. The spinal implant assembly may include an inertial measurement unit having a plurality of accelerometers and a plurality of gyroscopes. The inertial measurement unit may include a first accelerometer and a first gyroscope for measuring data associated with a first measurement axis. The inertial measurement unit may include a second accelerometer and a second gyroscope for measuring data associated with a second measurement axis. The inertial measurement unit may include a third accelerometer and a third gyroscope for measuring data associated with a third measurement axis. The inertial measurement unit may include an inclinometer. The inertial measurement unit may include a strain sensor or other types of sensors that measure and / or respond to deflection. The inertial measurement unit may include one or more of an accelerometer, a gyroscope, an inclinometer, and a strain sensor. For example, the inertial measurement unit may include an accelerometer, a gyroscope, and an inclinometer. The cannula may have a certain length and a circular, elliptical, square, or rectangular cross-section. The cannula may have a cross-section having a corner radius associated with a square or rectangular cross-section. The cannula may be mechanically coupled to an interbody spacer or a spinal cage. The cannula may be reversibly coupled to an interbody spacer or a spinal cage. The cannula may form a one-way positive connection with an interbody spacer or a vertebral cage. The cannula may be mechanically coupled to an interbody spacer or a spinal cage using at least one of a corresponding snap ring, lock, twist, thread, or chemical adhesive. The cannula may be press-fitted into an interbody spacer or a spinal cage. The cannula may include a plurality of sensors positioned on the top surface of the cannula. The cannula may include a plurality of sensors positioned on the bottom surface of the cannula. The cannula may include at least one sensor positioned on the proximal surface of the cannula. The cannula may include at least one sensor positioned on the distal surface of the cannula. The plurality of sensors positioned on the top surface of the cannula and the plurality of sensors positioned on the bottom surface of the cannula may be configured to measure the subsidence of an interbody spacer or a spinal cage. At least one sensor may be on the proximal surface of the cannula, and the distal surface of the cannula provides movement related to the translation and orientation of an interbody spacer or a vertebral cage. The plurality of sensors positioned on the top surface of the cannula may be in series. The plurality of sensors positioned on the bottom surface of the cannula are in series. The cannula may include a series of three sensors on the top surface of the cannula, a series of three sensors on the bottom surface of the cannula, a plurality of sensors on the proximal end of the cannula, and a plurality of sensors on the distal end of the cannula. The antenna may extend from the proximal or distal end of the cannula. The spinal implant assembly may include a processor. The spinal implant assembly may be inserted into a portion of the patient's lumbar spine. The spinal implant may be inserted into a portion of the patient's cervical spine. The interbody spacer or the spinal implant may be inserted into a portion of the patient's thoracic spine. At least one sensor may be an ultrasonic sensor. The ultrasonic sensor may be an M-mode sensor. The ultrasonic sensor may be a B-mode sensor. The ultrasonic sensor may be a low-power sensor. The antenna may be a loop antenna. The antenna may be a conformal antenna. In one embodiment, the antenna provides data transmission. The antenna may continuously transmit sensor data. The antenna may intermittently transmit sensor data.At least one sensor can continuously detect one or more physiological parameters. At least one sensor can intermittently detect one or more physiological parameters. The spinal implant assembly can include a power source for supplying power to at least one sensor. The power source can be rechargeable. At least one sensor can be powered by a power source external to the patient's body. In one embodiment, the antenna can be an inductive power receiver for secondary capacitance or battery charging. The spinal implant assembly can include a memory device for storing data from at least one sensor.

[0014] In some aspects, a method of sampling data from an implantable cartridge coupled to an interbody spacer or spinal cage implanted in a patient is disclosed. The method can include detecting one or more kinematic measurements associated with movement of the patient and generating sensor data. The method can include transmitting the sensor data to a receiver at a remote location and receiving data from the receiver.

[0015] The method of sampling data may include one or more of the following steps and features. The method may include detecting one or more kinematic measurements that occur during patient movement. The method may include detecting one or more kinematic measurement values that occur when the interbody spacer or the spinal cage is under load. The method may include calibrating the implantable cartridge when the patient is in a known position. The known position may be when the patient is lying down. The known position may be when the patient is standing against a wall. The known position may be when the patient's back is at a predetermined angle when the patient is in a sitting position. The predetermined angle may be 30 degrees, 45 degrees, or 90 degrees. One or more kinematic measurement values may be used to determine the fusion of the interbody spacer or the spinal cage. One or more kinematic measurement values may be used to determine the subsidence of the interbody spacer or the spinal cage. One or more kinematic measurement values may be used to determine the migration of the interbody spacer or the spinal cage. The migration of the interbody spacer or the spinal cage may be used to measure the translation of the interbody spacer or the spinal cage at the implantation site. One or more kinematic measurement values may be used to determine patient movement. The determined patient movement may include, for example, one of step count, cadence, walking speed, movement angle, and gait. The method may be configured to determine how quickly the patient can resume regular activities. The implantable cartridge of the method may include at least one sensor that is capable of detecting one or more kinematic measurements associated with the patient and generating sensor data. The implantable cartridge may include an antenna that is in electrical communication with the at least one sensor. The antenna may transmit the sensor data to a receiver at a remote location and receive data from the receiver. The implantable cartridge may include a battery. The method may include detecting one or more kinematic measurements, including obtaining the one or more kinematic measurements from an inertial measurement unit having a plurality of accelerometers and / or a plurality of gyroscopes. The method may include detecting tilt using a tilt sensor. The tilt sensor may be used to detect the angular movement of the implant. The method may include detecting deflection on the implant by using a strain sensor. The method may include measuring data associated with a first measurement axis, wherein the data associated with the first measurement axis is obtained from a first accelerometer and a first gyroscope of the inertial measurement unit. The method may include measuring data associated with a second measurement axis, wherein the data associated with the second measurement axis is obtained from a second accelerometer and a second gyroscope of the inertial measurement unit. The method may include measuring data associated with a third measurement axis, wherein the data associated with the third measurement axis is obtained from a third accelerometer and a third gyroscope of the inertial measurement unit. Optionally, the measured data is obtained from a tilt sensor. Optionally, the measured data is obtained from a strain sensor.

[0016] In some aspects, a spinal implant assembly for use during spinal fusion is disclosed. The spinal implant assembly may include a spinal implant. The spinal implant may include a body. The spinal implant may further include an opening at a first end of the body. The spinal implant may include a cavity that extends through the body of the spinal implant from the opening toward a second end side of the body. The spinal implant may include a cartridge configured to be inserted into the cavity, wherein the cartridge includes an outer wall configured to accommodate a plurality of components.

[0017] The spinal implant may include one or more of the following features. The spinal implant may include a locking structure for securing the spinal implant to the cartridge. The spinal implant may include at least one of a top surface or a bottom surface of the body, the top surface or the bottom surface of the body including a plurality of ridges, wherein the plurality of ridges are configured to improve the engagement of the spinal implant with adjacent vertebrae. The spinal implant may include a hole extending from the top surface of the body to the bottom surface of the body. In some aspects, the hole of the spinal implant is configured to be filled with a biological or synthetic material to assist spinal fusion. In some aspects, the spinal implant is an interbody spacer or a spinal cage.

[0018] In some aspects, the cartridge may include a power source. The cartridge may include a processor. The cartridge may include a memory device for storing data from at least one sensor. The power source may include a disposable battery or a rechargeable battery. The cartridge may include an antenna. In some aspects, the antenna may be positioned on the cartridge within the opening of the spinal implant. For example, the antenna may be positioned within the outer wall of the cartridge. In some aspects, the antenna is at least one of a loop antenna and a conformal antenna. In some embodiments, the antenna continuously transmits sensor data. In some examples, the antenna intermittently transmits sensor data. In some aspects, the cartridge may include at least one sensor. In some instances, the at least one sensor is an ultrasonic sensor. In some embodiments, the ultrasonic sensor is a low-power sensor. In some instances, the at least one sensor continuously or intermittently detects one or more physiological parameters.

[0019] The cartridge may have one or more of the following features. In some embodiments, the cartridge may include a certain length and a circular, elliptical, square, or rectangular cross-section. In some embodiments, the outer wall has a wall thickness of about 0.5 mm. The outer wall may have a wall thickness of less than 1 mm. The cartridge may have an aspect ratio of 1:2. The cartridge may have an aspect ratio of 2:3. The cartridge may have a width of 8 mm, a thickness of 4 mm, and a length of 28 mm. The cartridge may be reversibly coupled to the spinal implant.

[0020] In some embodiments, the spinal implant may include a locking structure. In some embodiments, the locking structure may include locking spring fingers configured to deform outwardly on the spinal implant when inserted into the cannula and configured to move back to a proper position once fully inserted into the cannula. In some instances, the locking structure may include a pin positioned on the spinal implant and a locking ledge positioned on the cannula, wherein the pin on the spinal implant is configured to hold the locking ledge to retain the cannula after insertion. In some embodiments, the locking flange has the radius of the pin. In some embodiments, the locking structure may include a clip or groove positioned along the length of the cannula, wherein the clip or groove is configured to hold the cannula within the spinal implant.

[0021] In certain aspects, an intelligent implant assembly for implanting into a patient's body is disclosed. The intelligent implant assembly may include an implant body and a cannula. In some embodiments, the implant body may include an opening on a first end of the implant body. The implant body may include a cavity that extends through the implant body from the opening toward a second side of the implant body. In some instances, the cannula may be inserted into the intelligent implant, wherein the cannula is held within the cavity of the implant body and within the outer perimeter of the implant body. In some embodiments, the cannula may include an outer wall configured to house a plurality of components. In certain aspects, the intelligent implant assembly may include a locking structure for securing the spinal implant to the spinal implant. In some aspects, at least one of a left surface of the body or a right surface of the implant body includes a plurality of ridges, wherein the plurality of ridges are configured to improve the engagement of the spinal implant with adjacent ridges.

[0022] The cannula may have one or more of the following characteristics. In some instances, the cannula includes a power source. The power source may include a disposable battery or a rechargeable battery. The cannula may include an antenna. The antenna may be positioned on the cannula within the opening of the spinal implant. The antenna may be positioned within the outer wall of the cannula. The antenna may be at least one of a loop antenna and a conformal antenna. The antenna may transmit sensor data continuously. The antenna may transmit sensor data intermittently. In some embodiments, the cannula includes a processor. In some instances, the cannula includes at least one sensor. The at least one sensor may be an ultrasonic sensor. The ultrasonic sensor may be a low-power sensor. The sensor may continuously or intermittently detect one or more physiological parameters of the patient and generate sensor data. In some embodiments, the cannula may include a memory device for storing data from the at least one sensor. The cannula may have a certain length and a circular, oval, square, or rectangular cross-section. In some embodiments, the cannula has an outer wall with a wall thickness of about 0.5 mm. The outer wall may have a wall thickness of less than 1 mm. In some instances, the cannula has an aspect ratio of 1:2. In some embodiments, the cannula has an aspect ratio of 2:3. The cannula may be reversibly coupled to the spinal implant.

[0023] The locking structure may have one or more of the following features. For example, the locking structure includes locking spring fingers configured to deform outwardly on the spinal implant when inserted into the cannula and configured to move back to a proper position once the cannula is fully inserted. In some instances, the locking structure includes a pin positioned on the spinal implant and a locking ledge positioned on the cannula, wherein the pin on the spinal implant is configured to hold the locking ledge to retain the cannula after insertion. In some embodiments, the locking flange has a radius of the pin. The locking structure may include a clip or a groove positioned along the length of the cannula, wherein the clip or the groove is configured to hold the cannula within the spinal implant.

[0024] In some embodiments, a method of monitoring a patient's recovery after spinal fusion is disclosed. The method may include providing a spinal implant assembly including a spinal implant and a cannula, the cannula including at least one sensor. In some instances, the method may include collecting, by the at least one sensor, data indicative of at least one of fusion, subsidence, or migration of the spinal implant. In some embodiments, the method may include transmitting the data to a remote location. In some embodiments, the data includes kinematic measurements of patient movement. The data may indicate movement of the spinal implant.

[0025] The spinal implant may include an opening and a cavity at a first end of the spinal implant, wherein the cavity extends from the first end of the spinal implant through the body to a second end of the spinal implant. A cannula may be configured to be inserted into the opening of the spinal implant such that the cannula is fixed within the cavity of the spinal implant. In some embodiments, the cannula includes a power source, a memory source, and a processor. In some instances, one of the at least one sensors includes an accelerometer and / or a gyroscope. In some instances, one of the at least one sensors includes an accelerometer and / or a gyroscope and / or an inclinometer and / or a strain sensor. The accelerometer and / or gyroscope may be configured to measure at least one of a patient's step count, step speed, walking speed, movement angle, or gait. In some embodiments, one of the at least one sensors includes at least one ultrasonic sensor. The at least one ultrasonic sensor may be configured to detect translation of the spinal implant. In some embodiments, translation of the spinal implant may be configured to measure migration of the spinal implant from the patient's implantation site. In some embodiments, the at least one ultrasonic sensor is configured to measure a distance between a surface of the spinal implant and an adjacent vertebra. In some instances, a change in the distance between a surface of the spinal implant and an adjacent vertebra is configured to measure subsidence of the spinal implant. In some embodiments, at least one sensor includes at least one inclinometer. In some embodiments, at least one sensor includes at least one strain sensor or other sensor that measures deflection. The inclinometer and / or strain sensor may be used, for example, to detect angular movement. In some embodiments, at least one sensor includes at least one vibration sensor. The at least one vibration sensor may be configured to detect acoustic emissions associated with the spinal implant for an adjacent vertebra. The acoustic emissions may be configured to measure fusion of the spinal implant relative to an adjacent vertebra. In some embodiments, at least one sensor is configured to calibrate the cannula when the patient is in a known position. In some instances, the spinal implant is an interbody spacer or spinal cage.

[0026] In certain aspects, a method for monitoring a patient's recovery after spinal fusion is disclosed. The method may include receiving data from a spinal implant assembly. The method may include processing the data to evaluate migration of the spinal implant, subsidence of the spinal implant, and / or fusion of the spinal implant. The method may include providing an output to a clinician based on the processed data.

[0027] In some embodiments, the data may include kinematic measurements. The patient kinematic measurements may be associated with at least one of a patient's step count, cadence, walking speed, movement angle, or gait. The data may include measurements indicative of migration of a spinal implant. In some embodiments, the method may include determining migration of the spinal implant based on translation of the spinal implant. In some embodiments, the data includes measurements indicative of subsidence of the spinal implant. In some instances, the method further includes determining subsidence of the spinal implant based on a change in distance between a surface of the spinal implant and an adjacent vertebra. In some instances, the data includes measurements indicative of fusion of the spinal implant with an adjacent vertebra. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Exemplary features of the present disclosure, their nature, and various advantages will be apparent from the drawings and the following detailed description of various embodiments. Non-limiting and non-exhaustive embodiments are described with reference to the drawings, in which like reference numerals refer to like parts throughout the various views, unless otherwise specified. The sizes and relative positions of the elements in the drawings are not necessarily drawn to scale. For example, the shapes of the various elements are selected, enlarged, and positioned to improve drawing legibility. The particular shapes of the elements drawn have been selected for ease of identification in the drawings. One or more embodiments are described below with reference to the drawings, in which:

[0029] Figure 1A Another sensor assembly in the form of a spinal cage with an insertable cartridge is illustrated, where the cartridge includes an implantable reporting processor.

[0030] Figure 1B and Figure 1C illustrates Figure 1A a perspective view of the insertable cartridge.

[0031] Figure 2A Another sensor assembly in the form of a spinal cage with an insertable cartridge is illustrated, where the cartridge includes an implantable reporting processor.

[0032] Figure 2B 、 Figure 2C and Figure 2D illustrates Figure 2A a cross-sectional view of the insertable cartridge.

[0033] Figure 3 A sensor assembly in the form of a spinal cage with an insertable cartridge is illustrated, where the spinal cage includes a window.

[0034] Figure 4A illustrates Figure 1A and Figure 1B a medial-lateral cross-sectional view of the sensor assembly.

[0035] Figure 4B illustrates Figure 2A and Figure 2B Inner-lateral cross-sectional view of the sensor assembly

[0036] Figure 5A Illustrates a front-back-front view of a sensor assembly with a spinal cage having an insertable cartridge, where the spinal cage does not include a window

[0037] Figure 5B Illustrates a front-back-front view of a sensor assembly with a spinal cage having an insertable cartridge, where the spinal cage includes a window

[0038] Figure 6 Shows an implantable sensor assembly of any one of Figure 1A , 1B, 1C, 2A, 2B, 3, 4A, 4B, 5A and 5B implanted in a patient's spine during spinal fusion

[0039] Figure 7 Shows a context diagram of a smart implant environment in a patient's home

[0040] Figure 8 Shows a block diagram of an implantable circuit for an implantable sensor assembly, such as an implantable interbody spacer, where the circuit includes an implantable reporting processor (IRP)

[0041] Fig. 9 Shows another block diagram of an implantable circuit for an implantable sensor assembly, such as an implantable interbody spacer, where the circuit includes an implantable reporting processor (IRP)

[0042] Fig.10 Shows Figure 8-9 The inertial measurement unit (IMU) of the implantable reporting processor and a set of coordinate axes within the reference frame of the IMU

[0043] Fig.11A , 11B, 11C, 11D and 11E show various views of the loop antenna

[0044] Fig.12 Illustrates a substrate antenna according to certain aspects of the present disclosure

[0045] Fig.13 Illustrates an embodiment of a planar inverted-F (PIFA) antenna according to certain aspects of the present disclosure

[0046] Fig.14 Shows an embodiment of a helical antenna

[0047] Fig.15A block diagram of an implantable circuit for an implantable sensor assembly, such as an implantable interbody spacer, is shown.

[0048] Fig.16A A front and rear view of another embodiment of an implantable sensor assembly including an interbody spacer having an insertable cylinder is shown.

[0049] Fig. 16B Shows Fig.16A A rear and front view of the implantable sensor assembly.

[0050] Fig. 16C Shows Fig.16A A side view of another embodiment of the implantable sensor assembly.

[0051] Fig.16D And 16E Respectively show Fig.16A A front perspective view and a rear perspective view of the implantable sensor assembly.

[0052] Fig.16F Shows Fig.16A A top view of the implantable sensor assembly.

[0053] Figure 16G Shows Fig.16A A bottom view of the implantable sensor assembly.

[0054] Fig.16H Shows Fig.16F A cross-sectional view of the implantable sensor assembly of the separate line A-A and the insertable cylinder positioned within the opening of the implantable sensor assembly.

[0055] Fig.16I Shows Fig.16H A cross-sectional view of the implantable sensor assembly with the insertable cylinder removed.

[0056] Fig.17 A perspective view of another embodiment of the implantable sensor assembly with an implantable report processor inserted is shown.

[0057] Fig.18 Shows for insertion into Figures 16A-16I And Fig.17 A schematic diagram of an implantable report processor cylinder for the interbody spacer shown in.

[0058] Fig.19A Shows for Fig.18 An embodiment of a locking structure for holding the cylinder of within the interbody spacer.

[0059] Fig.19B Shows for Fig.18Another embodiment of a locking structure for holding a cannula within an interbody spacer.

[0060] Fig.19C Shows a locking structure for holding a Fig.18 cannula within an interbody spacer.

[0061] Fig. 20A Shows a cross-sectional view of a cannula having an antenna positioned within an interbody spacer.

[0062] Fig. 20B Shows a front view of the cannula, where the antenna is positioned within the Fig. 20A interbody spacer of the body. DETAILED DESCRIPTION

[0063] As our population ages, there is an increasing need for devices such as spinal implants to relieve pain and treat various conditions. Spinal implants can be used to treat deformities, stabilize and strengthen the spine, and promote fusion. Once a spinal implant - such as an interbody spacer and a spinal cage - is inserted into a patient, a doctor must determine whether the surgery has helped to address the patient's condition. A successful surgery should allow the patient to resume a normal life with minimal pain. Traditionally, to evaluate the success of a spinal implant, a doctor would rely on the patient to indicate that they are experiencing pain or difficulty resuming activities, as a measure of the patient's condition. However, relying on patient feedback can be limiting because patients may not understand how to express the discomfort they are experiencing. Similarly, patients may be unreliable narrators of their physical activities. Also, relying solely on indirect measurements has limitations because doctors cannot diagnose problems associated with spinal surgery and the position of spinal implants. For example, an interbody spacer or a spinal cage can migrate (i.e., move away from the implant site) and / or subside (i.e., a decrease in the vertical height of the disc space before fusion is complete) after surgery, causing pain to the patient.

[0064] In the currently disclosed sensor assembly, it is configured to allow a doctor to indirectly and / or directly measure a patient's recovery. The sensor assembly can measure a patient's condition and indirectly monitor the patient's general movement and lifestyle changes. For example, if a patient is unable to return to a patient's previously preferred activity, it may indicate that a spinal implant may not be resolving the patient's condition. Similarly, if a patient is experiencing pain, a change in gait, or a significant reduction in physical activity, this can also be an indirect measurement that the patient continues to experience back pain and that the spinal implant has failed to resolve the patient's condition. As will be discussed in more detail below, the spinal implant includes multiple sensors that can allow a doctor to determine whether the patient's general mobility has changed. This can include, for example, a change in the frequency of a patient's walking, whether the patient is walking with a bowel movement, and whether the patient has a change in gait (e.g., limping). In combination with lifestyle information from the patient (e.g., feeling pain or continuing to participate in a preferred activity), these changes can inform the patient that additional surgery may be needed to address the patient's condition.

[0065] However, indirect measurement of a patient's condition can be limiting because it cannot answer the "why" of a patient's pain. As will be discussed, the disclosed sensor assembly includes multiple sensors capable of determining whether fusion has occurred between vertebrae, whether a spinal implant has migrated, and / or whether a spinal implant is experiencing resorption. This additional information can provide a doctor with the ability to more accurately and precisely diagnose the patient's condition and the pain being experienced.

[0066] An integrated sensor technology for spinal fusion procedures via (a) inter-implant and / or post-placement device(s) is disclosed, which provides clinically relevant objective data after surgery for patients and clinicians (a subset of similar data can be captured preoperatively with (a) wearable device(s) containing the same sensors). Multiple sensors (accelerometers, gyroscopes, force gauges, strain gauges, temperature sensors, etc.) within the implant device (or wearable) passively or on demand collect raw data, which can be uploaded to a cloud infrastructure to be processed into clinical metrics and then used for display on a designated user interface.

[0067] In some embodiments, the processed data provides metrics as a tool for a doctor to monitor their patient. The processed data from measurements of algorithms and methods for patient movement can produce but are not limited to: steps (steps per day), walking distance per day, average walking speed, spinal angle, patient position (lying down, hunched, or upright), and range of spinal motion.

[0068] In some instances, the processed and analyzed data collected from the smart implant can provide patient outcome monitoring, such as percent fusion or earlier detection of complications in the smart implant, such as a spinal implant (e.g., loosening / non - union, subsidence, migration). Multiple analyses and calculations can be used to determine these metrics. For example, to detect the percent fusion, vibration analysis is performed algorithmically on in - vivo prosthesis vibration data from an accelerometer (or other sensor). Such vibrations can be explicitly detected and correlated with established moments in the gait cycle (i.e., heel strike, neutral, toe - off, etc.) or other established movement motions. By correlating the vibration patterns with known movements, the exact moments of interest can be analyzed. Analyzing spinal fusion over time, as the bone grows and fuses adjacent vertebrae, the amplitude of the vibration will decrease, thus indicating spinal fusion.

[0069] The present disclosure may be more readily understood by reference to the following detailed description of embodiments of the present disclosure and examples of implantable medical devices having an implantable reporting processor. The following description, together with the accompanying drawings, sets forth certain specific details in order to provide a thorough understanding of the various disclosed embodiments. However, one of ordinary skill 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 without other methods, components, devices, materials, etc. In other instances, well - known structures or components associated with the environment of the present disclosure, including but not limited to communication systems and networks, are not shown or described to avoid unnecessarily obscuring the description of the embodiments.

[0070] Spinal surgeries such as spinal fusion generally refer to surgical procedures and related implantable medical devices, such as spinal implant systems (e.g., spinal fusion implants such as intervertebral body fusion cages or spacers, rods or plates, or spinal non - fusion implants such as artificial discs or expandable rods).

[0071] Before elaborating on the present disclosure in more detail, it may be helpful to provide definitions of certain terms that will be used herein. Additional definitions are set forth throughout the present disclosure. The terms "comprise" and "comprising" and their derivatives mean including but not limited to including. The term "or" is inclusive and means and / or. The phrases "associated with" and "associated therewith" and their derivatives may mean including, included within, interconnected with, containing, connected with, connected to or in communication with, in communication with, cooperating with, interlacing, juxtaposing, adjacent to, having the property of... or associated with... etc. The term "controller" or "processor" means any device, system or portion thereof that controls at least one operation, such devices may be implemented in hardware (e.g., electronic circuitry), firmware or software, or in some combination of at least two thereof. The functions associated with any particular controller may be centralized or distributed, whether local or remote. Other definitions of certain words and phrases may be provided in this patent document. One of ordinary skill in the art will understand that in many cases, if not most cases, such definitions apply to the prior and future use of such defined words and phrases.

[0072] The "intelligent medical device" used in the present disclosure is an implantable or implanted medical device that is expected to replace or functionally supplement a subject's natural body part. As used herein, the term "intelligent implant" refers to an implantable medical device having an implantable reporting processor. "Intelligent implant" may be interchangeably referred to as "implantable sensor assembly" or "intelligent device".

[0073] In some embodiments, the smart implant is an implantable or implant medical device having an implantable reporting processor arranged to perform the functions described herein. The smart implant may perform one or more of the following exemplary actions to characterize the post-implant state of the smart implant: identify the smart implant or a portion of the smart implant, e.g., by identifying one or more unique identification codes of the smart implant or a portion of the smart implant; detect, sense, and / or measure parameters, which may be collectively referred to as monitored parameters, in order to collect operational kinematics, or other data regarding the smart implant or a portion of the smart implant, and wherein such data may optionally be collected over time; store the collected data within the smart implant or a portion of the smart implant; and transmit the collected data and / or stored data from the smart implant or a portion of the smart implant to an external computing device by wireless means. The external computing device may have or otherwise be able to access at least one data storage location, such as found on a personal computer, base station, computer network, cloud-based storage system, or another computing device having access to such storage.

[0074] As used herein, "monitoring data" individually or collectively includes some or all of the data associated with a particular implantable sensor assembly and available for external communication in a particular implantable sensor system. For example, kinematic data may include raw data from one or more sensors of a smart implant, where the one or more sensors include, e.g., gyroscopes, accelerometers, pedometers, strain gauges, etc., which produce data associated with motion, force, tension, velocity, or other mechanical forces. Monitoring data may also include processed data from one or more sensors, status data, operational data, control data, fault data, time data, schedule data, event data, log data, etc., associated with a particular sensor assembly. In some cases, high-resolution monitoring data includes monitoring data from one, more, or all sensors of a sensor assembly collected at a higher quantity, resolution, from more sensors, etc., and at a higher frequency.

[0075] In some embodiments, kinematics refers to the measurement of the position, angle, velocity, and acceleration of body segments and joints during movement. Position describes the location of a body segment or joint in space, measured in distance, e.g., in meters. A related measurement called displacement refers to the position relative to the starting position. In two dimensions, the position is given in Cartesian coordinates, where the horizontal position is followed by the vertical position.

[0076] "Sensor" refers to a device that can be used to perform one or more of the following: 1) one or more different aspects (anatomical, physiological, metabolic, and / or functional) of body tissue, 2) one or more aspects (healing, movement, including measuring the position, angle, velocity, and acceleration of body segments and joints) of the condition or function of the body or a body segment / joint, and / or 3) one or more aspects of an implant. Representative examples of sensors suitable for the present invention include, for example, fluid pressure sensors, fluid volume sensors, contact sensors, position sensors, pulse pressure sensors, blood volume sensors, blood flow sensors, chemical sensors (e.g., for blood and / or other fluids), metabolic sensors (e.g., for blood and / or other fluids), accelerometers, mechanical stress sensors, and temperature sensors. In certain embodiments, the sensor can be a wireless sensor, or in other embodiments, a sensor connected to a wireless microprocessor. In further embodiments, one or more (including all) sensors can have a unique sensor identification number ("USI") that specifically identifies the sensor. In certain embodiments, a sensor is a device that can be used to quantitatively measure one or more different aspects (anatomical, physiological, metabolic, and / or functional) of body tissue and / or one or more aspects of an implant. In certain embodiments, the sensor is an accelerometer that can be used to quantitatively measure one or more different aspects (e.g., function) of body tissue and / or one or more aspects (e.g., alignment within a patient) of an implant.

[0077] A variety of sensors (also referred to as microelectromechanical systems or "MEMS" or nanoelectromechanical systems or "NEMS" and BioMEMS or BioNEMS) can be used in the present disclosure.

[0078] Intelligent planting system

[0079] The intelligent implant system includes 1) one or more of the sensors that detect and / or measure the function of the implant and / or the immediate environment around the implant and / or the activities of the patient, 2) a memory that stores the data from the detection and / or measurement, 3) an antenna that transmits the data; 4) a base station that receives the data generated by the sensors and can transmit the data and / or the analyzed data to a cloud-based location; 5) a cloud-based location that can store and analyze the data, and the analyzed data can be stored and / or further analyzed; 6) a receiving terminal that receives the output from the cloud-based location, where the receiving terminal can be accessed, for example, by a medical professional or an insurance company or the manufacturer of the implant, and the output can identify the status of the implant and / or the function of the implant and / or the status of the patient who has received the implant, and can also provide suggestions for resolving any concerns raised by analyzing the raw data.

[0080] Figure 7 A context diagram of the intelligent implant environment 1000 is shown. It should be recognized that the individual components of the implant environment 1000 are not essential or indispensable. Any component described herein can be practiced using any device suitable for performing the described function.

[0081] In the environment, the intelligent implant 1002 is implanted into a patient by a practicing physician ( Figure 7 (not shown in Figure 7 ). The intelligent implant 1002 has an associated IRP that is arranged and configured to collect data, including, for example, medical and health data related to the patient with which the device is associated, operational data of the device 1002, and kinematic data associated with a particular movement of the patient or a particular part of the patient's body, as well as operational data of the device 1002 itself. At different stages of detecting the patient, the intelligent implant 1002 communicates with one or more base stations 1004 or one or more intelligences 1005.

[0082] For example, in association with a medical procedure, the intelligent implant 1002 is implanted into a patient. Simultaneously with the medical procedure, the intelligent implant 1002 communicates with the operating room base station ( Figure 7 ). Subsequently, after fully recovering from the medical procedure, the patient returns home, where the intelligent implant 1002 is arranged to communicate with the home base station 1004. It should be understood that the home base station can be a separate device or can be a smart phone with a customized application that includes software capable of communicating with the intelligent implant. At other times, the intelligent implant 1002 is arranged to communicate with the doctor's office base station ( Figure 7 (not shown in

[0083] The intelligent implant 1002 includes one or more measurement units to collect information and data associated with the use of the body part associated with the intelligent implant 1002. In some embodiments, the information and data collected are patient-related medical and health data associated with the device. For example, the intelligent implant 1002 may include an inertial measurement unit, which includes (a plurality of) gyroscopes, (a plurality of) accelerometers, (a plurality of) gauges, or other motion sensors to collect the medial / lateral acceleration data, front / back, and the front / down axis of the associated body part; the sagittal angular velocity, frontal, and transverse to the plane of the associated body part; force, pressure, tension, stress, strain, migration, vibration, bending, stiffness, or some other measurable data.

[0084] The intelligent implant 1002 collects data at different times and various rates during the monitoring process of the patient. In some embodiments, the intelligent implant 1002 may operate at multiple different stages during the process of monitoring the patient, such that more data is collected shortly after the intelligent implant 1002 is implanted in the patient, but less data is collected as the patient heals and thereafter.

[0085] The amount and type of data collected by the intelligent implant 1002 may vary from patient to patient, and the amount and type of data collected may change for an individual patient. For example, a physician studying the data collected by the intelligent implant 1002 of a particular patient may adjust or otherwise control how the intelligent implant 1002 collects future data.

[0086] The amount and type of data collected by the intelligent implant 1002 may be different for different body parts, for different types of patient conditions, for different patient demographics, or other differences. Alternatively or additionally, the amount and type of data collected may change over time based on other factors, such as how the patient heals or feels, how long the monitoring process is expected to last, how much battery power remains and should be conserved, the type of movement being monitored, the body part being monitored, etc. In some cases, the data collected may be supplemented with personal descriptive information provided by the patient, such as subjective pain data, quality of life metric data, comorbidities, the patient's perception or expectations associated with the intelligent implant 1002, etc.

[0087] In some embodiments, the smart implant 1002 is implanted in a patient to monitor movement or other aspects of a specific body part or the smart implant 1002 itself. Implanting the smart implant 1002 in the patient 1 can be performed in an operating room. As used herein, an operating room includes any office, room, building, or facility in which the smart implant 1002 can be implanted in a patient. For example, the operating room can be a typical operating room in a hospital, an operating room in a surgical clinic or doctor's office, or any other operating room, intervention room, intensive care unit, emergency room, etc. where the smart implant 1002 is implanted in a patient.

[0088] An operating room base station ( Figure 7 not shown) is used to configure and initialize the smart implant 1002 in association with the smart implant 1002 implanted in a patient. For example, a communication relationship can be formed between the smart implant 1002 and the operating room base station based on a polling signal transmitted by the operating room base station and a response signal transmitted by the smart implant 1002.

[0089] When forming a communication relationship that typically occurs before implanting the smart implant 1002, the operating room base station ( Figure 7 not shown) transmits initial configuration information to the smart implant 1002. The initial configuration information can include, but is not limited to, a timestamp, a day stamp, an identification of the type and placement of the smart implant 1002, information about other implants associated with the smart implant, surgeon information, patient identification, operating room information, etc.

[0090] In some embodiments, the initial configuration information is passed unidirectionally; in other embodiments, the initial configuration is passed bidirectionally. The initial configuration information can define at least one parameter associated with data collection by the smart implant 1002. For example, the configuration information can identify settings for one or more sensors on the smart implant 1002 (e.g., accelerometer range, accelerometer output data rate, gyroscope range, gyroscope output data rate, etc.) for each of one or more operating modes. The initial configuration information can also include other control information, such as the initial operating mode of the smart implant 1002, a specific event that triggers a change in the operating mode, radio settings, data collection information (e.g., how often the smart implant 1002 wakes up to collect data, how long it collects data, how much data it collects), identification information for the home base station 1004, the smart device 1005, and the connected personal assistant 1007, as well as other control information associated with the implantation or operation of the smart implant 1002. The connected personal assistant 1007 can also be referred to as a smart speaker, examples of which include Google a patient display, Comcast's health tracking speaker, and Apple

[0091] In some configurations, the initial configuration information can be pre-stored on the operating room base station ( Figure 7 not shown) or on an associated computing device. In other configurations, a surgeon, surgical technician, or some other medical practitioner 2 can input control information and other parameters into the operating room base station 4 for transmission to the smart implant 1002. In at least one such configuration, the operating room base station can communicate with an operating room configuration computing device. The operating room configuration computing device 3 can include an application with a graphical user interface that enables a medical practitioner to input configuration information for the smart implant 1002. In various configurations, the application executed on the operating room configuration computing device 3 can have some of the predefined configuration information, which may or may not be adjustable by the medical practitioner 2.

[0092] The operating room configuration computing device 3 can transmit the configuration information to the operating room base station 4 via a wired (as shown in FIG. 1) or wireless network connection (e.g., via a USB connection, Bluetooth connection, Bluetooth Low Energy (“BTLE”) connection, or Wi-Fi connection), which can transmit it to the smart implant 1002.

[0093] The operating room configuration computing device ( Figure 7 not shown) can also display information to the surgeon, surgical technician, or other medical practitioner regarding the smart implant 1002 or the operating room base station ( Figure 7 not shown). For example, if the smart implant 1002 is unable to store or access configuration information, if the smart implant 1002 is unresponsive, if the smart implant 1002 identifies a problem with a sensor or radio device during an initial self-check, if the operating room base station ( Figure 7 not shown) is unresponsive or fails, or for other reasons, the operating room configuration computing device can display an error message.

[0094] Although the operating room base station and the operating room configuration computing device are described as separate devices, the embodiments are not limited thereto; rather, the functions of the operating room configuration computing device and the operating room base station can be included in a single computing device or in separate devices as shown. Thus, in one embodiment, Physician 1 can be enabled to input configuration information directly into the operating room base station 4.

[0095] Returning to Figure 7, Once the smart implant 1002 is implanted into a patient and the patient returns home, the home base station 1004, the smart device 1005 (e.g., the patient's smartphone), the connected personal assistant or two or more home base stations, and the computing or smart device, and the connected personal assistant can communicate with the smart implant 1002. The smart implant 1002 can collect data at a determined rate and time, a variable rate and time, or otherwise controllable rate and time. When the smart implant 1002 is initialized in the operating room, when the practitioner 1 indicates, or at some later time point, data collection can begin. At least some of the data collected by the smart implant 1002 can be directly transmitted to the home base station 1004, directly transmitted to the connected personal assistant 1007, directly transmitted to the base station via one or both of the smart device and the connected personal assistant, transmitted to the smart device via one or both of the base station and the connected personal assistant, or transmitted to the connected personal assistant via one or both of the smart device and the base station. Here, "one or two" means only through one item and through two items continuously or in parallel. For example, the data collected by the smart implant 1002 can be serially transmitted to the home base station via the separate smart device 1005, via the connected personal assistant 1007, via the smart device and the connected personal assistant, via the connected personal assistant and the smart device, and directly and possibly simultaneously via the smart device and the connected personal assistant. Similarly, the data collected by the smart implant 1002 can be continuously transmitted to the smart device via the separate home base station, via the connected personal assistant, via the home base station and the connected personal assistant, via the connected personal assistant and the home base station, and directly and possibly simultaneously via the home base station and the connected personal assistant. In addition, in an example, the data collected by the smart implant 1002 can be continuously transmitted to the connected personal assistant via the separate smart device 1005, via the home base station 1004, via the smart device and the home base station, via the home base station and the smart device, and directly and possibly simultaneously via the smart device and the home base station.

[0096] In various configurations, one or more home base stations, smart devices, and connected personal assistants can ping the smart implant 1002 at periodic, predetermined, or other times to determine whether the smart implant 1002 is within the communication range of one or more home base stations, smart devices, and connected personal assistants. Based on the responses from the smart implant 1002, one or more home base stations 1004, smart devices 1005, and the connected personal assistant 1007, it is determined that the smart implant 1002 is within the communication range, and the smart implant 1002 can be requested, commanded, or otherwise directed to transmit the data it has collected to one or more of the home base station 1004, smart device 1005, and the connected personal assistant 1007.

[0097] In some cases, each of one or more of the femtocell 1004, the smart device 1005, and the connected personal assistant 1007 may be arranged with a respective optional user interface. The user interface may be formed as a multimedia interface for unidirectional or bidirectional transfer of one or more types of multimedia information (e.g., video, audio, tactile, etc.). Through the respective user interfaces of one or more of the femtocell 1004, the smart device 1005, and the connected personal assistant 1007, a patient ( Figure 7 not shown) or a patient's colleague ( Figure 7 not shown) may input additional data to supplement the data collected by the smart implant 1002. For example, the user may input personal descriptive information (e.g., age changes, weight changes), changes in medical conditions, comorbidities, pain levels, quality of life, or other subjective metric data, personal messages for the physician, etc. In these configurations, the personal descriptive information may be input using a keyboard, mouse, touch screen, microphone, wired or wireless computing interface, or some other input device. In cases where personal descriptive information is collected, the personal descriptive information may include one or more identifiers that associate the information with a unique identifier of the smart implant 1002, the patient, the associated medical practitioner, the associated medical facility, etc. or otherwise associate it.

[0098] In these cases, the respective optional user interface of each of one or more of the femtocell 1004, the smart device 1005, and the connected personal assistant 1007 may also be arranged to deliver information associated with the smart implant 1002 from, for example, the medical practitioner 2 to the user. In these cases, the information delivered to the user may be delivered via a video screen, an audio output device, a tactile transducer, a wired or wireless computing interface, or some other similar means.

[0099] In a configuration of one or more femtocells 1004, the smart device 1005 and the connected personal assistant 1007 are arranged with a user interface that may be formed with an internal user interface arranged to communicatively couple with a patient entry device. The patient entry device may be a smart phone, a tablet computer, a body-worn device, a weight or other health measurement device (e.g., thermometer, bathroom scale, etc.), or some other computing device capable of wired or wireless communication. In these cases, the user is able to input personal descriptive information and the user may also be able to receive information associated with the smart implant 1002.

[0100] The home base station 1004 can utilize the patient's home network 1006 to transmit the collected data to the cloud 1008. The home network 1006, which can be a local area network, provides access from the patient's home to a wide area network such as the Internet. In some configurations, the home base station 1004 can utilize a Wi-Fi connection to connect to the home network 1006 and access the Internet. In other embodiments, the home base station 1004 can be connected to the patient's home computer ( Figure 7 not shown in the figure) via, for example, a USB connection, and the USB connection itself is connected to the home network 1006.

[0101] The smart device 1005 can communicate directly with the smart implant 1002 via, for example, compatible signals, and can transmit data to the cloud using the patient's home network, or can communicate directly with the cloud via a cellular network. Alternatively, the connected personal assistant can be configured to communicate directly with one or both of the base station 1004 and the connected personal assistant 1007 via, for example, compatible signals, and is not configured to communicate directly with the smart implant 1002.

[0102] In addition, the connected personal assistant 1007 can communicate directly with the smart implant 1002 via, for example, compatible signals, and can transmit the collected data to the cloud 1008 using the patient's home network 1006, or can communicate directly with the cloud via, for example, a modem / Internet connection or a cellular network. Alternatively, the connected personal assistant 1007 can be configured to communicate directly with one or both of the base station 1004 and the smart device 1005 via, for example, compatible signals, and is not configured to communicate directly with the smart implant 1002.

[0103] In addition to transmitting the collected data to the cloud 1008, one or more of the home base stations 1004, smart devices 1005, and networked personal assistants 1007 can also obtain data, commands, or other information directly from the cloud 1008 or via the home network 1006. One or more of the home base stations 1004, smart devices 1005, and networked personal assistants 1007 can provide some or all of the received data, commands, or other information to the smart implant 1002. Examples of such information include, but are not limited to, updated configuration information, diagnostic requests to determine whether the smart implant 1002 is operating properly, data collection requests, and other information.

[0104] The cloud 1008 can include one or more server computers or databases to aggregate the data collected from the smart implant 1002, and in some cases from the patient ( Figure 7Personal descriptive information collected (not shown) from other intelligent implantable devices (not shown), and in some cases from other patients. In this way, the cloud can create various different metrics on the data collected from each of the multiple intelligent implantable devices implanted into individual patients. This information helps determine whether the intelligent implantable device is operating properly. The information collected can also be used for other purposes, such as determining which specific devices may not be operating properly, determining whether the procedures or conditions associated with the intelligent implantable device are helping the patient, and determining other medical information.

[0105] Throughout the monitoring process, the patient may be required to make a follow-up appointment with a medical practitioner. This physician can be the surgeon who implanted the intelligent implant 1002 into the patient, or a different physician who oversees the patient's monitoring process, physical therapy, and recovery. For various different reasons, the physician may wish to collect real-time data from the intelligent implant 1002 in a controlled environment. In some cases, the request from the practicing physician can be delivered through the corresponding optional two-way user interfaces of one or more of the home base station 1004, the intelligent device 1005, and the networked personal assistant 1007.

[0106] The practicing physician uses a doctor's office base station ( Figure 7 not shown) to transfer additional data between the doctor's office base station and the intelligent implant 1002. In some embodiments, the practicing physician uses the doctor's office base station ( Figure 7 not shown) to pass commands to the intelligent implant 1002. In some configurations, the doctor's office base station can instruct the intelligent implant 1002 to enter a high-resolution mode to temporarily increase the rate or type of data collected over a short period of time. The high-resolution mode instructs the intelligent implant 1002 to collect a different (e.g., larger) amount of data while the practicing physician is also monitoring the patient's activities.

[0107] In some configurations, the doctor's office base station can enable the physician to enter event markers that can be synchronized with the high-resolution data collected by the intelligent implant 1002. For example, assume that the intelligent implant 1002 is a component located in the spine. When the intelligent implant 1002 is in high-resolution mode, the practicing physician can have the patient walk on a pedal. While the patient is walking, the patient may complain of his / her back pain. The practicing physician can click the pain marker button on the doctor's office base station to indicate the patient's discomfort. The doctor's office base station records the marker and the time of marker entry. When the timing of this marker is synchronized with the timing of the collected high-resolution data, the physician can analyze the data to try and determine the effect of the medication.

[0108] In other embodiments, the doctor's office base station ( Figure 7(not shown) can provide updated configuration information to the smart implant 1002. The smart implant 1002 can store the updated configuration information, which can be used to adjust parameters associated with data collection. For example, if the patient is in good condition, the physician can instruct to reduce the frequency of data collection by the smart implant 1002. Conversely, if the patient is experiencing an unexpected amount of pain, the practitioner can direct the smart implant 1002 to collect additional data over a determined period (e.g., several days). The physician can use the additional data to diagnose and treat specific problems. In some cases, the additional data can include personal descriptive information provided by the patient after the patient has left the presence of the physician and is no longer within the range of the doctor's office base station. In these cases, the personal descriptive information can be collected and delivered via one or more of a home base station, a smart device, and a connected personal assistant. Firmware within the smart implant and / or the base station can provide safeguards to limit the duration of such enhanced monitoring to ensure that the battery maintains sufficient power to last the life cycle of the implant.

[0109] In some embodiments, a doctor's office base station ( Figure 7 not shown) can communicate with a doctor's office configuration computing device ( Figure 7 not shown). The doctor's office configuration computing device can include an application with a graphical user interface that enables a medical practitioner to input commands and data. Some or all of the commands, data, and other information can subsequently be transmitted to the smart implant 1002 via the doctor's office base station. For example, in certain configurations, the medical practitioner can use the graphical user interface to instruct the smart implant 1002 to enter its high-resolution mode. In other configurations, the physician can use the graphical user interface to input or modify the configuration information of the smart implant 1002. The doctor's office configuration computing device can transmit information (e.g., commands, data, or other information) to the doctor's office base station via a wired or wireless network connection (e.g., via a USB connection, connection, or Wi-Fi connection), and the connection can in turn transmit some or all of the information to the smart implant 1002.

[0110] The doctor's office configuration computing device can also display other information about the smart implant 1002 regarding the patient (e.g., personal descriptive information), or the doctor's office base station. For example, the doctor's office configuration computing device can display high-resolution data collected by the smart implant 1002 and transmitted to the doctor's office base station. If the smart implant 1002 is unable to store or access configuration information, if the smart implant 1002 is unresponsive, if the smart implant 1002 identifies a problem with a sensor or radio, if the doctor's office base station is unresponsive or fails, or for other reasons, the doctor's office configuration computing device can also display an error message.

[0111] In some configurations, a doctor's office configured computing device ( Figure 7 not shown) may access Cloud 1008. In at least one embodiment, a medical practitioner may use the doctor's office configured computing device to access data stored in Cloud 1008 that was previously collected by Smart Implant 1002 and transmitted to Cloud 1008 via one or both of Home Base Station 1004 and Smart Device 1005. Similarly, the doctor's office configured computing device may transmit high-resolution data obtained from Smart Implant 1002 via the doctor's office base station to the cloud. In some configurations, the doctor's office base station may have Internet access and may be enabled to directly transmit high-resolution data to the cloud without using the doctor's office configured computing device.

[0112] In various configurations, when the patient is not in the physician's office, the physician may update the configuration information of Smart Implant 1002. In these cases, the medical practitioner may use the doctor's office configured computing device ( Figure 7 not shown) to transmit updated configuration information to Smart Implant 1002 via Cloud 1008. One or more Home Base Stations 1004, Smart Devices 1005, and Connected Personal Assistant 1007 may obtain the updated configuration information from Cloud 1008 and pass the updated configuration information along. This may allow the medical practitioner to remotely adjust the operation of Smart Implant 1002 without requiring the patient to come to the medical practitioner's office. This may also allow the physician to send a message to the patient ( Figure 7 not shown) in response to, for example, personal descriptive information provided by the patient and passed through one or more of Home Base Station 1004, Smart Device 1005, and Connected Personal Assistant 1007 connected to the doctor's office base station. For example, if a patient who has undergone spinal fusion says "My back hurts" when walking into Connected Personal Assistant 1007, the practicing physician may prescribe pain medication and have the connected personal assistant "say" to the patient "The doctor has called in a prescription for you to your preferred pharmacy; the prescription will be ready for pick-up at 4:00 PM."

[0113] Although the doctor's office base station and the doctor's office configured computing device are described as separate devices, the configuration is not limited thereto; rather, the functions of the doctor's office configured computing device and the doctor's office base station may be included in a single computing device or separate devices (as shown). In this way, it is possible to enable the direct input of configuration information or markers into the doctor's office base station in one configuration and view high-resolution data (and synchronized marker information) from a display on the doctor's office base station.

[0114] Still referring to Figure 7, alternative embodiments are envisioned. For example, one or both of the femtocell 1004, the smart device 1005, and the connected personal assistant 1007 may be omitted from the smart implant environment 1000. Additionally, each of the femtocell 1004, the smart device 1005, and the connected personal assistant 1007 may be configured to communicate with one or both of the implantable device 1002 and the cloud 1008 via another or two of the femtocell, the smart device, and the connected personal assistant. Further, the smart device 1005 may be temporarily reduced to an interface with the implantable device 1002 and may be any suitable device other than a smart phone, such as a smart watch, a smart patch, and any IoT device capable of acting as an interface with the implantable device 1002, such as a coffee can. Additionally, one or more of the femtocell 1004, the smart device 1005, and the connected personal assistant 1007 may act as a communication hub for multiple prostheses implanted in one or more patients. Moreover, one or more of the femtocell 1004, the smart device 1005, and the connected personal assistant 1007 may automatically order or reorder prescriptions or medical supplies (e.g., calcium channel blockers) in response to patient input or implantable prosthesis input (e.g., pain level, clotting level); alternatively, one or more of the femtocell, the smart device, and the personal assistant may be configured to request authorization from a medical expert or an insurance company to place an order or reorder. Additionally, one or more of the femtocell 1004, the smart device 1005, and the networked personal assistant 1007 may be configured with a personal assistant such as or .

[0115] Intelligent planting system

[0116] The present disclosure provides a medical device, including a prosthesis or a medical device that can be implanted in a patient (implant), which can be used to monitor and report the status and / or activity of the medical device, including postoperative activity and the progress of the patient involved, as well as its characteristics. The present disclosure provides a smart implant or an implantable sensor assembly that realizes the benefits of a medical implant, such as the benefits provided by a prosthesis, which replaces or supplements the natural function of a patient, while also realizing the benefits of monitoring and reporting, which provides insights into the function and / or condition of the device and / or the patient who has received the implanted device. The medical device may be an implantable device, which is an implantable prosthesis in vivo that can be implanted into the body of a living host (also referred to as a patient), for example, to improve the function of the biological structure of the patient's body or replace the biological structure of the patient's body.

[0117] The present disclosure provides intelligent implants, such as implantable medical devices having an implantable reporting processor (IRP), also referred to herein as a "cylinder". When the intelligent implant is included as a component of an implant system replacing a joint, the intelligent implant can monitor the displacement or movement of the component or implant system. The intelligent implant can also provide kinematic data that can be used to evaluate the mobility and health of a patient of the implant system.

[0118] Non-limiting and non-exhaustive lists of examples of intelligent implants include components of spinal implants coupled to sensors. Examples of spinal devices and implants include pedicle screws, spinal rods, spinal wires, spinal plates, spinal cages, artificial discs, facet implants, bone cements, and combinations thereof (e.g., one or more pedicle screws and a spinal rod, one or more pedicle screws and a spinal plate). Additionally, medical delivery devices for placing spinal devices and implants and one or more sensors can also be intelligent medical devices according to the present invention. Examples of medical delivery devices for spinal implants include kyphoplasty balloons, catheters (including thermal catheters and bone tunnel catheters), bone cement injection devices, microsurgical dissection tools, and other surgical tools.

[0119] In some embodiments, the spinal devices and implants can be any type of in vivo fusion device (posterolateral fusion (PLIF), transforaminal lumbar interbody fusion (TLIF), anterior lumbar interbody fusion (ALIF), or lateral lumbar interbody fusion (LLIF)) in a single-level or multi-level fusion (i.e., L4-L5 single-level versus L1-L5 multi-level). These implants can be made of any biocompatible material, but are typically PEEK or titanium.

[0120] The intelligent implant (or sensor assembly) can include an implantable reporting processor (IRP) incorporated into a spinal cage or intervertebral spacer used during spinal fusion. The spinal fusion device can be inserted at any location along the patient's spine. For example, a spinal fusion device can be inserted to provide spinal fusion in the lumbar, thoracic, and / or cervical spine. The spinal fusion device can be configured to withstand loads from adjacent vertebrae and can include an opening for accommodating the IRP. In an example using a spinal fusion device and a separate IRP cartridge, a doctor connects the IRP to the spinal fusion device to form the intelligent implant. In an alternative configuration, the IRP can be integrated with the implant and include any of the features of the cartridge-type IRP described herein. The doctor can then fill the spinal fusion device with a material to help hold the IRP and enhance fusion between adjacent vertebrae. For example, the spinal fusion device can be filled with a bodily material (e.g., blooded sawdust), other biological material, or other synthetic material. As will be discussed in more detail below, the IRP can form a cartridge that can be permanently or reversibly inserted into the spinal fusion device. The cartridge can include an antenna, an inertial measurement unit (IMU), and / or additional sensors capable of sensing and tracking patient movement.

[0121] FIG. 26A illustrates a perspective view of an intelligent implant 101 in the form of a spinal cage, which includes an implantable reporting processor 150. The implantable reporting processor 150 can be connected to a spinal fusion device / intervertebral spacer as shown in FIG. 26A. For example, the components can be assembled during surgery. The spinal fusion device can have various different shapes and sizes. As shown, the spinal fusion device can include a top surface 102, a bottom surface 104, an intermediate surface 106, and side surfaces 108. The inner surface 106 can include an opening 110 and / or the outer surface 108 can include an opening 112. The opening 110 and / or the opening 112 can allow the implantable reporting processor 150 to be inserted and fixed within the spinal cage of the intelligent implant 101.

[0122] The implantable reporting processor 150 can include a housing 180 that encapsulates a battery, electronic components, an antenna, and / or one or more sensors. The one or more sensors can include any of the sensors described herein. The housing 180 can include a cover or casing that surrounds and secures the various components of the implantable reporting processor 150. For example, as shown in FIG. 26A, the implantable reporting processor 150 is in the form of a cartridge for insertion into a patient. The cartridge can be any shape or size such that it can be inserted into the spinal cage. For example, the implantable reporting processor 150 of FIG. 26A is thin and wafer-shaped to allow it to be inserted through the opening 110 or the opening 112 of the spinal cage. The implantable reporting processor 150 can be generally D-shaped, having a generally curved intermediate end 156b and generally straight side ends 158b. However, the implantable reporting processor 150 can be cylindrical or any other shape or size. As shown in FIGS. 26B-26C, the implantable reporting processor 150 can include a housing 180 that covers and encloses the battery and electronic components. In some embodiments, the implantable reporting processor 150 can include a top surface 152, a bottom surface 154, an intermediate surface 156a, and side surfaces 158a. In some embodiments, the antenna 160 of the implantable reporting processor 150 can have a radome that extends from the outer profile of the implantable reporting processor 150, such as the intermediate end 156b of the implantable reporting processor 150. When assembled with the spinal cage / intervertebral spacer, the radome can protrude from the outer profile of the spacer. This arrangement allows communication even if the implantable reporting processor 150 and / or the spacer have metallic materials. As described in more detail herein, the implantable reporting processor 150 and / or the spinal fusion device / intervertebral spacer can communicate with an external device, such as using Bluetooth Low Energy, to transmit collected data or receive programming and configuration data. The antenna 160 can be optimized for frequencies in the range of 2.4 to 2.5 GHz.

[0123] As will be discussed in more detail below, the implantable reporting processor 150 may include one or more sensors located on various surfaces of the implantable reporting processor 150. As shown in FIGS. 26A - 26C, the implantable reporting processor 150 may include at least one sensor 170. The at least one sensor 170 may be sealed and mounted inside the implantable reporting processor 150 or attached to the surface of the implantable reporting processor 150, such as on the top surface 152 of the implantable reporting processor 150. As shown in FIGS. 26A - 26C, the at least one sensor 170 of the implantable reporting processor 150 may include sensors 170a, 170b, and 170c. Sensors 170a, 170b, 170c may be placed in series.

[0124] The at least one sensor 170 may include a strain or force sensor to detect strain or force on the surface of the implantable reporting processor 150 as a means of detecting fusion between two adjacent vertebrae in which the spacer is placed, since the load increases as the fusion progresses.

[0125] The at least one sensor 170 may include a vibration sensor that detects acoustic emissions related to scraping / wearing of the intervertebral spacer against adjacent vertebrae. As the intervertebral fusion progresses, the degree of acoustic emissions changes (most likely decreases).

[0126] The vibration sensor may be combined with an accelerometer to collect acoustic emission (vibration) measurements when the patient performs a known activity such as walking. The accelerometer may be a low - power AC or DC accelerometer. The accelerometer may be sealed inside the implantable reporting processor 150. The accelerometer may measure the tilt angle of the spine relative to the gravity vector; the spine angle relative to the gravity vector provides a center - of - mass measurement; the center - of - mass measurement is related to the patient's recovery, pain level, and / or health status. The accelerometer may measure the patient's activity pattern (e.g., walking) and trigger the accelerometer to collect data during a target activity (e.g., walking).

[0127] Although the at least one sensor 170 is shown on the top surface of the implantable reporting processor 150, the sensor may be located on any other surface of the implantable reporting processor 150, as described below. Additionally, in other embodiments, the at least one sensor 170 may be incorporated into the spacer itself.

[0128] Additionally or alternatively, the implantable reporting processor 150 may include at least one sensor 172 on the bottom surface 154 of the implantable reporting processor 150. As shown in FIGS. 26A - 26C, the at least one sensor 172 of the implantable reporting processor 150 may include sensors 172a, 172b, and 172c. Sensors 172a, 172b, 172c may be placed in series.

[0129] In some configurations, the implantable reporting processor 150 may include at least one sensor 174 on an intermediate surface 156a of the implantable reporting processor 150. As shown in FIGS. 26A-26C, at least one sensor 174 of the implantable reporting processor 150 includes sensor 174a and sensor 174b. However, in various configurations, at least one sensor 174 may include more or fewer sensors. In some configurations, the implantable reporting processor 150 may include at least one sensor 176 on a side surface 158a of the implantable reporting processor 150. As shown in FIGS. 26A-26C, at least one sensor 176 of the implantable reporting processor 150 may include sensor 176a and sensor 176b. However, in various configurations, at least one sensor 176 may include more or fewer sensors. In some embodiments, at least one sensor 170, at least one sensor 172, at least one sensor 174, and at least one sensor 176 may be embedded within the material of the housing 180.

[0130] The implantable reporting processor 150 may be in the form of a cylinder that may be inserted into a spinal cage through an opening 110 in the inner surface 106 or an opening 112 in the outer surface 108. In some embodiments, the implantable reporting processor 150 may form a positive connection with the spinal cage prior to insertion of the spinal cage into the patient. For example, the positive connection may be any of a variety of mechanical connections such as snap-fit, locking, twisting, mating threads, etc. In some embodiments, the implantable reporting processor 150 may be reversibly inserted into the spinal cage. The reversible connection between the implantable reporting processor 150 and the spinal cage may provide the doctor with the option to remove the cartridge in the event that any maintenance is required once the implantable reporting processor 150 has been inserted into the patient. The reversible connection may allow removal of the implantable reporting processor 150 in the event that the battery may need to be replaced.

[0131] FIG. 27A illustrates a smart implant 101 that includes an implantable reporting processor 250 for insertion into a spinal cage of the smart implant 101. The implantable reporting processor 250 may include any of the features described above with respect to the implantable reporting processor 150. FIG. 27A illustrates an implantable reporting processor 250 for insertion into a spinal cage that includes an antenna 260 that does not protrude from the surface of the implantable reporting processor 250.

[0132] Like the implantable report processor 150, the implantable report processor 250 can include a housing 280 that encapsulates a battery 290, electronic components 240, an antenna 260, and multiple sensors. Similar to the implantable report processor 150, the housing 280 of the implantable report processor 250 includes a lid or housing that covers and secures the various components of the implantable report processor 250. For example, as shown in FIG. 27A, the implantable report processor 250 is in the form of a cartridge for insertion into a patient's body. The implantable report processor 250 can be any shape or size such that it can be inserted into the smart implant 100. For example, the implantable report processor 150 of FIG. 26A is thin and wafer-shaped to allow it to be inserted through the opening 110 or opening 112 of the spinal cage. However, as described above with respect to the implantable report processor 150, the implantable report processor 250 can be cylindrical or any other shape or size. As shown in FIGS. 27A-27C, the implantable report processor 250 can include a top surface 252, a bottom surface 254, an intermediate surface 256a, and a side surface 258a. The implantable report processor 250 can include a housing 280 that covers and encloses the antenna 260 and the electronic components 240 at the intermediate end 256b of the implantable report processor 250 and covers and encloses the battery 290 at the side end 258b.

[0133] Similar to the implantable report processor 150, the implantable report processor 250 can include multiple sensors (e.g., ultrasonic sensors) located on the respective surfaces of the implantable report processor 250. As shown in FIGS. 27A-27D, the implantable report processor 250 can include at least one sensor 270 on the top surface 252 of the implantable report processor 250. As shown in FIGS. 27A-27C, at least one sensor 270 of the implantable report processor 250 is composed of a sensor 270a, a sensor 270b, and a sensor 270c. The sensors 270a, 270b, 270c can be placed in series along the top surface 252 of the implantable report processor 250.

[0134] Additionally or alternatively, the implantable report processor 250 can include at least one sensor 272 on the bottom surface 254 of the implantable report processor 250. As shown in FIGS. 27A-27C, at least one sensor 272 can include a sensor 272a, a sensor 272b, and a sensor 272c. The sensors 272a, 272b, 272c can be placed in series along the bottom surface 254 of the implantable report processor 250.

[0135] In some configurations, the implantable reporting processor 250 can include at least one sensor 274 on an intermediate surface 256a of the implantable reporting processor 250. As shown in FIGS. 27A - 27C, the at least one sensor 274 of the implantable reporting processor 250 consists of sensor 274a and sensor 274b. However, the at least one sensor 274 can include more or fewer sensors in any number of arrangements. In some configurations, the implantable reporting processor 250 can include at least one sensor 276 on a side surface 258a of the implantable reporting processor 250. As shown in FIGS. 27A - 27C, the at least one sensor 276 of the implantable reporting processor 250 can include sensor 276a and sensor 276b. However, the at least one sensor 276 can include more or fewer sensors in various configurations. In some embodiments, the at least one sensor 270, the at least one sensor 272, the at least one sensor 274, and the at least one sensor 276 can be embedded within the material of the housing 280.

[0136] FIG. 28 illustrates an intelligent implant 200 including a spinal cage. The intelligent implant 200 can include any of the features described above with respect to the intelligent implant 101. The intelligent implant 200 can include a top surface 202, a bottom surface 204, an intermediate surface 206, and side surfaces 208. The intelligent implant 200 includes an opening 210 in a window 220 and an opening 212 in a side surface 208. The intelligent implant 200 also includes a window 220 at an inner or outer end of the intelligent implant 200. In embodiments where the implantable reporting processor includes an antenna that does not extend outside of the intelligent implant 200, the window 220 can allow signals to be transmitted outside of the intelligent implant 200 without any interference. This is especially the case when the housing 280 of the implantable reporting processor 250 includes a material such as metal. In embodiments where the housing 280 includes a material such as PEEK, signal transmission is not blocked, and thus an intelligent implant 101 without a window can be used.

[0137] FIGS. 29A - 29B show medial - lateral cross - sectional views of the intelligent implant 101 with the implantable reporting processor 150 or the implantable reporting processor 250 inserted into the spinal cage. FIG. 29A illustrates a cross - sectional view in which the antenna 160 extends out of the opening 110 in the intermediate surface 106. FIG. 29B illustrates a cross - sectional view in which the entire implantable reporting processor 250 does not extend from either end of the intelligent implant 101 but is contained between the intermediate surface 106 and the side surface 108 of the intelligent implant 101.

[0138] Figures 30A - 30B show a proximal - anterior view of the implantable report processor 150 or implantable report processor 250 inserted into the smart implant 101 or smart implant 200. In Figure 29B, the window 220 of the implantable report processor 250 allows the top and / or bottom of the antenna 260 on the intermediate end 256b of the implantable report processor 250 to be exposed. Since this is the position where the antenna 260 is located below the housing 280, the antenna 260 can transmit signals out of the smart implant 200.

[0139] Figures 16A-16I Another embodiment of the smart implant 300 is shown, where the smart implant 300 is an inter - body spacer 301. In some embodiments, Figures 16A-16I the inter - body spacer 301 is a PLIF implant. Figure 27A illustrates the smart implant 101, which includes the implantable report processor 250 for insertion into the spinal cage of the smart implant 101. The implantable report processor 250 may include any of the features described above with respect to the implantable report processor 150. The implantable report processor 350 can be inserted into the inter - body spacer 301, as Figures 16H-16I shown.

[0140] As Figures 16A-16B shown, the inter - body spacer 301 may include a left surface 302, a right surface 304, a first end 306, a second end 308, a bottom surface 305, and a top surface 303. In some embodiments, depending on how the inter - body spacer 301 is inserted into the body, the bottom surface 305 may form the lower side of the inter - body spacer 301, and the top surface 303 may form the upper side of the inter - body spacer 301, or alternatively, the bottom surface 305 may form the lower side of the inter - body spacer 301, and the bottom surface 305 may form the upper surface of the inter - body spacer 301. The first end 306 may include an opening 310 that allows the implantable report processor 350 to be inserted into the inter - body spacer 301. As Figures 16H-16I shown in the cross - sectional view of, the inter - body spacer 301 may include a cavity 312 that extends internally from the opening 310 at the first end of the body 301 through the body 301 to the second end of the body 301. The opening 110 and / or opening 112 may allow the implantable report processor 150 to be inserted and fixed within the spinal cage of the smart implant 101. In some instances, the inter - body spacer 301 may be made of PEEK. The inter - body spacer 301 may also include a machined hole 330 on the first end 306 of the inter - body spacer 301. The inter - body spacer 301 may also include a plurality of tool cuts 340a, 340b at the first end 306 of the inter - body spacer 301. The machined hole 330 and the cuts 340a, 340b allow the doctor to insert the inter - body spacer 301 into the patient's spine.

[0141] In other instances, the interbody spacer 301 may be made of titanium. The smart implant 300 may be configured to be inserted at any location in the spine. For example, the smart implant 300 may include any one of an intervertebral lumbar spacer, an intervertebral cervical spacer, or an intervertebral thoracic spacer.

[0142] In some embodiments, the interbody spacer 301 may include a plurality of incisions and openings that better allow a doctor to fill the interbody spacer with a material to help hold the smart implant 300 in place and provide enhanced fusion between adjacent vertebrae. For example, a spinal fusion cage may be filled with bodily material (e.g., bloody sawdust), other biological materials, or other synthetic materials. As Figures 16A-16H shown, the interbody spacer 301 may include an opening 350 that forms a through hole extending from the front side of the interbody spacer 301 to the back side of the interbody spacer. As mentioned, the opening may be filled with a biological or synthetic material to aid in the fusion of adjacent vertebrae.

[0143] The interbody spacer 301 may include a ridged or grooved surface that provides indentations to better allow the smart implant 300 to be fixed between vertebrae in the body. As Figures 16A-16B shown, the top surface 303 includes a plurality of or alternating ridges 303a and grooves 303b. Similarly, the bottom surface 305 may also include a plurality of alternating ridges 305a and grooves 305b. The angled indentations formed on the top surface 303 and the bottom surface 305 increase the surface area of the interbody spacer 301 that engages adjacent vertebrae and provide better fixation of the smart implant 300 in the body.

[0144] The implantable reporting processor 350 may include a housing 380 that encloses many of the components for measuring patient kinematics and powering the smart implant 300. For example, the housing 380 may enclose a battery, electronic components, an antenna, and one or more sensors. One or more sensors may include any of the sensors described herein. The housing 180 may include a cover or housing that encloses and secures the various components of the implantable reporting processor 150. As Fig.16IAs shown, the implantable report processor 350 can be in the form of a cylinder for insertion into the smart implant 300. The cartridge can be of any shape or size such that it can be inserted into a spinal cage. In the presently shown embodiment, the implantable report processor 350 is shaped to fit within the opening 310 and cavity 312 of the interbody spacer 301. In some instances, the implantable report processor 350 can have a first portion 352 and a second portion 354, where the first portion 352 is larger than the second portion 354. The second portion 354 of the implantable report processor 350 can be sized such that it can be received within the cavity 312 of the interbody spacer 301. The first portion 352 of the implantable report processor 350 can be sized such that it can be received within the opening 310 but does not extend into the cavity 312. This can allow the implantable report processor 350 to be fixed and properly positioned within the body of the interbody spacer 301.

[0145] The implantable report processor 350 can be in the form of a cylinder that can be inserted through the opening 310 of the first end 306 into the interbody spacer 301. In some embodiments, the implantable report processor 150 can form a positive connection with a spinal fusion device before the spinal fusion device is inserted into a patient. For example, the implantable report processor 350 has a locking mechanism (e.g., a tab) that can lock with the interbody spacer 301. The positive connection can be any one of a number of mechanical connections, such as snap fit, lock, twist, mating threads, etc. In some embodiments, the implantable report processor 150 can be reversibly inserted into a spinal cage. The reversible connection between the implantable report processor 150 and the spinal cage can provide the doctor with the option to remove the cartridge in the event that any maintenance is required once the implantable report processor 150 has been inserted into the patient. The reversible connection can allow the implantable report processor 150 to be removed in the event that the battery may need to be replaced. In other embodiments, the locking mechanism is irreversible. The implantable report processor can include screws that can allow the implantable report processor 350 to be assembled with the interbody spacer 301 before implanting the smart implant 300.

[0146] In some embodiments, the implantable report processor 350 can be configured to communicate with an external device. The communication can be performed, for example, using Bluetooth Low Energy to transmit the collected data or receive programming and configuration data. In some embodiments, the implantable report processor can include an antenna that can be optimized for frequencies in the range of 2.4 to 2.6 GHz.

[0147] As will be discussed in more detail below, the implantable report processor 150 may include one or more sensors located on various surfaces of the implantable report processor 150. The at least one sensor 170 may be sealed and mounted inside the implantable report processor 150 or attached to the surface of the implantable report processor 150, such as on the top surface 152 of the implantable report processor 150.

[0148] The at least one sensor 170 may include a strain or force sensor to detect strain or force on the surface of the implantable report processor 150 as a means of detecting fusion between two adjacent vertebrae in which the spacer is placed, since the load increases as the fusion progresses.

[0149] The at least one sensor 170 may include a vibration sensor that detects acoustic emissions associated with scraping / wear of the intervertebral spacer against adjacent vertebrae. As the intervertebral fusion progresses, the degree of acoustic emissions changes (most likely decreases). The vibration sensor may be combined with an accelerometer to collect acoustic emission (vibration) measurements when the patient performs a known activity such as walking. The accelerometer may be a low-power AC or DC accelerometer. The accelerometer may be sealed inside the implantable report processor 150. The accelerometer may measure the angle of inclination of the spine relative to the gravity vector; the spine angle relative to the gravity vector provides a center of mass measurement; the center of mass measurement is related to the patient's recovery, pain level, and / or health condition. The accelerometer may measure the patient's activity pattern (e.g., walking) and trigger the accelerometer to collect data during a target activity (e.g., walking).

[0150] As discussed above, the implantable report processor in the form of a cartridge may be inserted into the intelligent implant. The cartridge may be inserted into the interbody spacer of the intelligent implant such that it does not extend beyond the perimeter of the geometry of the interbody spacer. This may prevent any interference of the cartridge with the surrounding soft tissue and nerve tissue (i.e., the spinal cord). This can be seen in Figures 16A-16I which shows the implantable report processor cartridge 350 inserted into the PLIF interbody spacer 301. As shown in the cross-sectional view of Fig.16H the first part of the cartridge 350 may be flush with the perimeter of the PLIF interbody spacer 301. In another embodiment shown in Fig.17 the implantable report processor cartridge 450 is inserted into the LLIF interbody spacer 401. As shown, the inner end 452 of the cartridge 450 is not flush with the perimeter of the LLIF interbody spacer 401 but extends within the perimeter.

[0151] In some embodiments, cylinders 350, 450 may have an outer wall configured to provide fracture / yield strength to maintain the expected load on the body - to - body spacers 301, 401. The outer wall of cylinders 350, 450 may have a minimum wall thickness of 0.5 mm. In some instances, the wall thickness of cylinders 350, 450 may be less than 1 mm. In some embodiments, the wall thickness may be 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1.0 mm, about 1.1 mm, about 1.2 mm. In some instances, the wall thickness may be between about 0.4 mm - 0.6 mm, between about 0.45 mm - 0.55 mm, between about 0.9 mm - 1.10 mm, between about 0.95 mm - 1.05 mm, between about 0.5 mm - 0.6 mm, between about 0.6 mm - 0.7 mm, between about 0.7 mm - 0.8 mm, between about 0.8 mm - 0.9 mm, between about 0.9 mm - 1.0 mm, and any value between the listed ranges, including the endpoints.

[0152] Fig.18 An embodiment of cylinder 500 is shown. In some embodiments, cylinder 550 may be rectangular, however the cylinder can be of any shape (e.g., cylindrical). Cylinder 550 may have a width - to - height aspect ratio of 1:2, which may provide optimized mechanical strength for handling compressive strength. In some embodiments, cylinder 550 may have a width - to - height aspect ratio of 2:3, which may also provide mechanical strength. In some embodiments, cylinder 550 may have a width - to - height aspect ratio of 4:12, 5:12, 6:12, 7:12, 8:12, 9:12, 10:12, about 4:12 - 5:12, about 5:12 - 6:12, about 6:12 - 7:12, about 7:12 - 8:12, about 8:12 - 9:12, about 9:12 - 10:12, and any aspect ratio between the listed ranges, including the endpoints. In some instances, the width - to - height aspect ratio may provide mechanical strength for handling compressive shear forces and torsional forces.

[0153] As Fig.18 shown, in some embodiments, cylinder 500 may include a power source, such as battery 552, electronics 554, and antenna 556. In some embodiments, cylinder 550 may have a height h of approximately 8 mm, a width w of approximately 28 mm, and a distance d of approximately 4 mm. In some embodiments, the length of cylinder 550 without an antenna is approximately 20 mm.

[0154] An implantable report processor in the form of a cylinder can be inserted into a smart implant. This feature allows the implantable report processor cylinder to be used in various applications and implants of different sizes. In some embodiments, the smart implant may include a locking structure to hold the implantable report processor cylinder within the interbody spacer such that once the smart implant is inserted into the patient's body, it does not fall out or become loose.

[0155] In addition to the embodiments discussed regarding the fixation of the cylinder, Fig.19A , FIGS. 19B and 19C illustrate various examples of mechanical locking structures. Fig.19A Locking mechanism 600a is shown, which includes interbody locking fingers 610a. The interbody locking fingers 610a of locking mechanism 600a can be passive locking spring fingers formed on the interbody spacer that can deform outwardly on the interbody spacer when cylinder 550 is inserted. In some embodiments, the cylinder design can have mechanical ramps and flanges such that when cylinder 550 is inserted, the interbody locking fingers 610a deform outwardly until cylinder 550 is fully inserted and the interbody locking fingers 610a move back to their proper position. In some embodiments, locking mechanism 600a can create a mechanical interference of at least 0.5 mm - 1 mm, which can hold cylinder 550 after insertion. In some instances, the interbody locking fingers 610a can be manufactured by additive manufacturing as features to fit within the interbody spacer.

[0156] Fig.19B Locking mechanism 600b is shown, which can include a locking pin 610b and a cylinder locking flange 612b. In some embodiments, locking mechanism 600b forms a passive locking flange design on cylinder 550. Locking mechanism 600b is configured to hold cylinder 550 within the interbody spacer by locking pin 610b, which is located on the interbody spacer. In some embodiments, the locking pin 610b of the cylinder can have a mechanical interference of at least 0.5 mm - 1.0 mm to hold cylinder 550 after insertion into the interbody spacer. In some embodiments, the locking flange 612b of cylinder 550 can have the radius of locking pin 610b. In some instances, the locking pin 610b can be an inserted pin / rod or a 3D printed feature contained within the interbody spacer.

[0157] Fig.19CShows a locking mechanism 600c positioned on the body of the cylinder 550. As shown, the locking mechanism 600c may include a locking clip 610c and a groove 620c. The locking clip 610c is configured to reduce its profile when compressed and expand its profile when decompressed. In some embodiments, the interbody spacer may include a groove (not shown). The locking clip 610c on the cylinder 550 may be compressed when inserted into the interbody spacer, but then expand / decompress when the cylinder 550 is inserted, such that the locking clip 610c is positioned within the groove of the interbody spacer.

[0158] In some embodiments, after the cylinder is assembled within the interbody spacer, the antenna may be configured to wirelessly communicate with an external source to transmit data. In some embodiments, the cylinder is fully contained within the interbody spacer, and the antenna has a line of sight that is not interrupted by the interbody spacer. Fig. 20A and 20B An embodiment of the cylinder 550 positioned within the interbody spacers 301, 401 is shown, where the cylinder is contained within the interbody spacers 301, 401. As shown, each of the cylinders 550 includes an antenna 556 positioned within the outer housing of the cylinder and within the opening of the interbody spacer such that the antenna 556 can transmit signals without interruption. A thief can provide optimal radio frequency efficiency, electric field strength, and radiation. In some embodiments, we desire to position the antenna 556 as far away from titanium material as possible while fully containing the cylinder 556 within the perimeter of the interbody spacers 301, 401. In some embodiments, the cylinder may have a 0.2 mm clearance around the cylinder 550 within the interbody spacers 301, 401.

[0159] FIG. 31 illustrates a posterior-anterior view of the intelligent implants 101, 200 inserted into a patient's spine 2310 during spinal fusion. As discussed above, the intelligent implants 100, 200 are in the form of interbody spacers and are inserted between adjacent vertebrae 20. The adjacent vertebrae 2320 may include a plurality of pedicle screws 2330 and rods 2340 that assist in fixing the vertebrae 2320 in place during and after spinal fusion.

[0160] Implantable Report Processor (IRP)

[0161] The present disclosure provides an implantable report processor (IRP) or cartridge for an implant system for spinal surgery. As previously described, the IRP can be a component assembly that is manufactured independently of other components of the implant system and subsequently assembled with the components of the implant system. However, in other configurations, the IRP can be integrated with the components of the implant system during the manufacture of the components. When integrated, the IRP can still include any of the features of the separate cartridge described herein. In some embodiments, the present disclosure provides a report processor that is intended to be implanted with a medical device, such as a prosthesis, where the report processor generally monitors the status of the device by obtaining kinematic data in the range of about 10 - 120 Hz after implantation.

[0162] As discussed herein, the status of the device can include the integrity of the device, movement of the device, forces applied to the device, and other information related to the implanted device. The present disclosure also provides medical devices having such a structure such that they can be easily fitted with an IRP. An implantable medical device equipped with an IRP is referred to herein as a smart implant because the implant is monitoring its own status or condition to obtain data, where the data is stored in the implant and then transmitted to a separate device as needed for review, for example, by a doctor.

[0163] For example, a smart implant of the present disclosure having suitable internal electronics can be used to monitor and measure the movement and kinematic movement of a surgical patient post - operatively (e.g., active gait, steps, posture, lumbar range of motion, etc.) after implanting the inter - body spacer or cage in the body during spinal fusion, store the measurement data and the unique identification information of the fixation components, and transmit the data to an external recipient (e.g., doctor, clinician, medical assistant, etc.). The IRP will include one or more sensors, such as gyroscopes, accelerometers, and temperature and pressure sensors, and these sensors can be located anywhere within the IRP housing, for example, they can all be located on a PC board. In some embodiments, for example, when the smart implant is fixed within the body spacer or cage, the IRP makes kinematic measurements, and in another embodiment, the IRP only makes kinematic measurements. Thus, the smart implant can include sensors for motion measurement to determine the movement experienced by the implanted prosthesis.

[0164] The IRP and the medical device are each intended to be implanted in a living subject, such as a mammal, such as a human, horse, dog, etc. Thus, in some embodiments, the IRP is sterile, for example, treated with sterilizing radiation or treated with ethylene oxide. In some instances, the smart implant, including the IRP and the medical device, is again optionally sterile by treatment with sterilizing radiation or ethylene oxide. To protect against the in - vivo environment, in some embodiments, the IRP is hermetically sealed such that fluid cannot enter the IRP.

[0165] In some embodiments, due to limited space within the body and / or within the prosthetic implant to place such devices, implantable devices need to be robust as well as small or space-efficient. The challenge for the commercial success of implantable devices with internal electronic components and internal or external transmitting antennas is that the device and / or the transmitting antenna should not be inappropriately large, their power consumption should allow them to operate for a suitably long period of time, i.e., not for a limited duration, and they should not be adversely affected by their local biological environment. The IRP of the present disclosure can have a suitably internal or external space-efficient and / or power-efficient antenna.

[0166] An IRP generally includes a housing enclosing a plurality of components. Exemplary suitable IRP components include a signal inlet, an electronic assembly, and / or a power source. The signal portal is for receiving and transmitting wireless signals and can include, for example, an antenna for transmitting wireless signals. The electronic assembly includes circuit components, which can include, for example, a PC board and electrical components formed on one or more integrated circuits (ICs) or chips, such as a radio transmitter chip, a real-time clock chip, one or more sensor components, such as an inertial measurement unit (IMU) chip, a temperature sensor, a pressure sensor, a tilt sensor, a strain sensor, a gauge, a memory chip, etc. Additionally, the electronic assembly can include a header assembly that provides a communication interface between the circuit components and the signal inlet (e.g., the antenna). The power source provides the energy required to operate the IRP and can be, for example, a battery. The IRP will also include one or more sensors, such as a gyroscope, an accelerometer, a pedometer, a tilt sensor, a strain sensor, and a temperature sensor and a pressure sensor, and these sensors can be located anywhere within the IRP housing, e.g., they can all be located on the PC board. More precisely, embodiments of the present disclosure relate to a space-efficient printed circuit assembly (PCA) for an implantable report processor (IRP). The implantable report processor can also include a plurality of transmitting antennas configured in different configurations. Thus, embodiments of the present disclosure relate to a plurality of enhanced space-efficient and power-efficient antenna configurations for an implantable report processor, such as an IRP.

[0167] Examples of implantable report processors include a housing or casing sized to fit within an implantable prosthesis or form a part of the implantable prosthesis, the implantable prosthesis having at least a portion designed to fit within a bone of a living patient. Electronic circuitry is disposed within the casing and is configured to provide information related to the prosthesis to a destination external to the patient's body. A battery is also disposed within the casing and is coupled to the electronic circuitry.

[0168] Figure 8 and Fig. 9A block diagram of an IRP that can be associated with a smart implant is shown. The components include a battery 1012, an RF antenna 1030, and an electronic assembly 1010 having various circuits powered by the power supply. Depending on the design, the circuits of the electronic assembly 1010 include a fuse 1014 coupled to the RF antenna 1030 and / or a controller 1032, one or more switches 1016, 1017, 1018, a clock and power management circuit 1020, one or more measurement units 1022, an accelerometer 1023, a memory 1024, communication components such as a radio frequency (RF) transceiver 1026 and an RF filter 1028. Not shown, but optionally present, is a tilt sensor. Also not shown, but optionally present, is a strain sensor.

[0169] Measuring unit

[0170] Overview

[0171] In some embodiments, the measurement unit can monitor one or more aspects of the implant. One or more sensors can be configured to detect, measure, and / or monitor information related to the state of the post-implant sensor assembly 300. The state of the device can include the integrity of the device, the movement of the device, the forces applied to the device, and other information related to the implanted device. This type of measurement unit 1022 can include a processor and one or more sensors located on the printed circuit board of the electronic assembly 1010, such as a gyroscope, an accelerometer, a tilt sensor, a strain sensor, and temperature and pressure sensors coupled to the processor. These sensors can also be located on the printed circuit board of the electronic assembly 1010. Alternatively, some or all of these sensors, such as the tilt sensor, the strain sensor, the gyroscope, the accelerometer, can be in or on another structure of the smart implant separate from the electronic assembly 1010.

[0172] In some embodiments, the measurement unit can monitor one or more aspects of the body or body segment / joint condition or function (e.g., healing, movement, including measuring the position, angle, velocity, and acceleration of the body segment and joint). One or more sensors 102 can be configured to detect, measure, and / or monitor information related to the state of the post-implant sensor assembly 100. The state of the body or body segment can include, for example, kinematic information, healing information of the body or body segment. This type of measurement unit 1022 can include a processor and one or more sensors located on the printed circuit board of the electronic assembly 1010, such as a gyroscope, an accelerometer, a tilt sensor, a strain sensor, electrodes, and temperature and pressure sensors coupled to the processor. These sensors can also be located on the printed circuit board of the electronic assembly 1010. Alternatively, some or all of these sensors can be in or on another structure of the smart implant device separate from the electronic assembly 1010.

[0173] In some embodiments, body tissue (e.g., anatomical, physiological, metabolic, and / or functional) can be monitored. The measurement unit 1022 can be configured to detect, measure, and / or monitor information related to body tissue after the implantation of the device. Body tissue monitoring can include, for example, pressure or pH level. This type of measurement unit 1022 can include a processor and one or more sensors located on the printed circuit board of the electronic component 1010, such as a fluid pressure sensor, a fluid volume sensor, a pulse pressure sensor, a blood volume sensor, a blood flow sensor, a chemical sensor (e.g., for blood and / or other fluids), a metabolic sensor (e.g., for blood and / or other fluids). These sensors can also be located on the printed circuit board of the electronic component 1010. Alternatively, some or all of these sensors can be in or on the structure of a smart implant device separate from the electronic component 1010.

[0174] The measurement unit can perform one or more of any of the above-described smart functions.

[0175] Inertial measurement unit

[0176] In some embodiments, the measurement unit 1022 is an inertial measurement unit (IMU). For example, the IMU can be a Bosch BMI 160 small, low-power IMU. As Fig.10 shown, the measurement unit 1022 includes three measurement axes 1060, 1062, and 1064, which are arbitrarily labeled x, y, and z for purposes of description. That is, in a Cartesian coordinate system, the labels "x", "y", and "z" can be arbitrarily applied to the axes 1060, 1062, and 1064 in any order or arrangement. The marker 1066 is a reference indicating the position and orientation of the axes 1060, 1062, and 1064 relative to the IMU package. The IMU can include one or more accelerometers, such as three accelerometers, each of which senses and measures the linear acceleration a(t) along a respective one of the axes 1060 (x), 1062 (y), and 1064 (z), where ax(t) is the acceleration along the x-axis, ay(t) is the acceleration along the y-axis, and az(t) is the acceleration along the z-axis. Each accelerometer generates a corresponding analog sensing or output signal that has an instantaneous magnitude representing the instantaneous magnitude of the acceleration sensed along the corresponding axis. For example, at a given time, the magnitude of the accelerometer output signal is proportional to the magnitude of the acceleration along the sensing axis of the accelerometer.

[0177] The IMU may include one or more gyroscopes, such as three gyroscopes, each gyroscope sensing and measuring the angular velocity Ω(t) about a respective one of axes 1060 (x), 1062 (y), and 1064 (z), where Ωx(t) is the angular velocity along the x-axis, Ωy(t) is the angular velocity along the y-axis, and Ωz(t) is the angular velocity along the z-axis. Each gyroscope generates a respective analog sensing or output signal having an instantaneous magnitude that represents the instantaneous magnitude of the sensed angular velocity about the corresponding axis. For example, the magnitude of the gyroscope output signal at a given time is proportional to the magnitude of the angular velocity about the sensing axis of the gyroscope at the same time.

[0178] The IMU may include one or more analog-to-digital converters (ADCs) for each of axes 1060, 1062, and 1064, such as one ADC for converting the output signal of a corresponding accelerometer into a corresponding digital acceleration signal, and another ADC for converting the output signal of a corresponding gyroscope into a corresponding digital angular velocity signal. For example, each of the ADCs may be an 8-bit, 16-bit, or 24-bit ADC.

[0179] Each ADC may be configured to have respective parameter values that are the same as or different from the parameter values of the other ADCs. Examples of such parameters having settable values include the sampling rate, the dynamic range at the (multiple) ADC input nodes, and the output data rate (ODR). One or more of these parameters may be set to a constant value, while one or more other of these parameters may be set dynamically (e.g., during run time). For example, the respective sampling rate of each ADC may be set dynamically such that during one sampling period, the sampling rate has one value, and during another sampling period, the sampling rate has another value.

[0180] For each digital acceleration signal and each digital angular velocity signal, the IMU may be configured to provide parameter values associated with the signal. For example, the IMU may provide the sampling rate, the dynamic range, and a timestamp indicating the time at which the first sample or the last sample was acquired, for each digital acceleration signal and for each digital angular velocity signal. The IMU may be configured to provide these parameter values in the form of a message header (with the corresponding samples forming the message payload) or in any other suitable form.

[0181] Ultrasound

[0182] In some embodiments, the IRP may include one or more ultrasound sensors. As will be discussed in more detail below, the ultrasound sensors provide a direct measurement of the subsidence of the spine and the migration of the intelligent implant after spinal fusion.

[0183] Ultrasonic sensors may be useful because they can make measurements using sound waves that are not affected by material or tissue overgrowth. In some embodiments, as described above with respect to FIGS. 1A-1C and 2A-2B, the ultrasonic sensor may be positioned on the surface of the intelligent implant.

[0184] The ultrasonic sensor used may be an M-mode or B-mode ultrasonic sensor. In some embodiments, the ultrasonic sensor is a B-mode ultrasonic sensor configured to measure distance. As will be discussed in more detail below, ultrasonic sensors positioned around the implantable reporting processor can provide direct measurements of various conditions of the spinal fusion device. For example, sensors positioned on the medial and lateral ends of the implantable reporting processor (e.g., at least one sensor 174, at least one sensor 176, at least one sensor 274, at least one sensor 276) can provide a direct measurement of the migration of the interbody spacer or spinal cage. This can be useful because it can help determine whether adjacent vertebrae have fused. If the interbody spacer or spinal cage continues to migrate, this can indicate to the doctor that spinal fusion has not fully occurred.

[0185] As another example, sensors positioned on the top and bottom surfaces of the implantable reporting processor (e.g., at least one sensor 170, at least one sensor 172, at least one sensor 270, at least one sensor 272) can provide a direct measurement of the subsidence of adjacent vertebrae. The sensors positioned on the top and bottom surfaces of the implantable reporting processor measure the distance between the interbody spacer or spinal cage and the adjacent vertebrae after insertion and over time. When the distance between the top surface of the interbody spacer or spinal cage and the first vertebra and / or the distance between the bottom surface of the interbody spacer or spinal cage and the second vertebra changes over time, this can indicate to the doctor anatomical changes due to loading and / or bone quality, which may result in pain associated with spinal deformity.

[0186] In some embodiments, the ultrasonic sensor may be an ultra-low power ultrasonic sensor that can be driven in the microamp range.

[0187] fuse

[0188] In some embodiments, the fuse 1014 can be any suitable fuse (e.g., permanent) or circuit breaker (e.g., resettable) configured to prevent the battery 1012 or current flowing from the battery from harming the patient and damaging the battery and one or more components of the electronic assembly 1010. For example, the fuse 1014 can be configured to prevent the battery 1012 from generating enough heat to burn the patient, damage the electronic assembly 1010, damage the battery, or damage the structural components of the intelligent implantable device.

[0189] communicate

[0190] RF Telemetry

[0191] The RF transceiver 1026 can be a transceiver configured to allow the controller 1032 (and optionally the fuse 1014) to communicate with a base station (not shown in Figure 8 here) configured to be used with an intelligent implant. For example, the antenna 112 can be any suitable type of transceiver (e.g., Low Energy (BTLE) and ), and can be configured to operate according to any suitable protocol (e.g., MICS, ISM, Low Energy (BTLE), Zigbee, and ), and can be configured to be in the range of 1 MHz - 5.4 or a suitable range.

[0192] The filter can be any suitable band - pass filter, such as a surface acoustic wave (“SAW”) filter or a bulk acoustic wave (“BAW”) filter.

[0193] Antenna - Overview

[0194] The antenna 112 can be adapted to the RF transceiver and / or the frequency band in which the antenna 112 generates signals for transmission and the frequency band in which the base station generates signals for reception by the antenna 112.

[0195] Loop Antenna

[0196] In some embodiments, the antenna 1030 can be a loop antenna. For example, the loop antenna can be a conductive loop formed by a platinum - iridium (PtIr = 90 / 10) strip, with one end connected to the radio transceiver and the other end connected to the battery reference potential (GND). The loop antenna provides a magnetic loop. For example, an AC signal in the conductive loop generates a magnetic field. The antenna can be encapsulated by a cover and an epoxy backfill, both of which are non - conductive. The antenna can be the only electro - active component of the implantable reporting processor outside the hermetic assembly and, under normal operating conditions, is insulated from the surrounding tissue by the epoxy backfill and the PEEK cover to avoid electrical interaction.

[0197] Figures 11A-11EShows multiple views of a loop antenna that can be configured to be used with an IRP and an integrated IRP. The loop antenna can be designed to transmit information generated by the electronic components of the IRP to a remote destination outside the body of a subject with an implanted intelligent implant and to receive information from a remote source outside the subject's body. The loop antenna can be a flat band 902 constructed in a loop 904 that has curved ends 906, a flat end 908 opposite the curved ends, and a pair of opposing sides 910, 912 extending between the curved and flat ends. The flat band 902 forming the loop antenna has a major surface 914 and a minor edge 916. Due to the skin effect on RF transmission, it may be necessary to maximize the cross-sectional surface area of the antenna to minimize RF energy loss while minimizing the PtIr volume and thus minimizing cost. The thickness of the flat band 902 represents an approximate minimum for maintaining the antenna shape during assembly, and the height (h) of the flat band enables the necessary surface area to be achieved.

[0198] Reference Figures 11A-11C The flat end 908 of 030 can be electrically coupled to the electronic components. To this end, the flat end 908 of the antenna 1030 includes a first portion 918 separated from a second portion 920 by a gap. The first portion 918 includes a first notch 922 at an edge configured to couple to a first feedthrough pin (not shown) of the electronic component 1010. The second portion 920 includes a second notch 924 at an edge configured to couple to a second feedthrough pin (not shown) of the electronic component.

[0199] In some embodiments, with respect to the material and surface finish of the loop antenna 1030, the antenna is formed of a material comprising platinum (Pt) in an atomic percentage range of 70% to 100% and iridium (Ir) in an atomic percentage range of 0% to 30%. In an exemplary configuration, the antenna 1030 is formed of Pt90Ir10. Platinum and Pt-Ir alloys are selected for the combination of biocompatibility, ductility, and conductivity.

[0200] In some embodiments, the major surface 914 of the antenna 1030 has a surface finish in the range of a maximum of 0 microinches and 15 microinches. In an exemplary configuration, the surface finish is a maximum of 6 microinches.

[0201] As described above, in the configuration of the IRP, the antenna 1030 is coupled to the electronic components through a dielectric feedthrough, a dielectric PEEK cover, and a backfill that surrounds the antenna. The backfill can be silicone or a medical-grade epoxy adhesive. Encapsulating the antenna in a dielectric, combined with the post-implant placement of the antenna in bone tissue and muscle, may affect antenna performance. However, the antenna 1030, geometry, orientation, material composition, surface finish, etc. disclosed herein, in combination with the circuitry of the electronic components, enables post-implant communication at both 2.45 GHz and the Medical Implant Communication System (MICS) band, such as 401 - 406 MHz, despite the presence of the dielectric and tissue.

[0202] In some embodiments, the loop antenna 1030 has been tuned as described above with reference to Figures 11A-11E to be able to receive ultra-low power wake-up olfactory signals on the 2.45 GHz channel and is also tuned to be able to receive and transmit data and information on a MICS channel, such as a 400 MHz channel.

[0203] Conformal antenna

[0204] In some embodiments, the antenna 1030 can be a conformal antenna. As Fig.12 shown, the conformal antenna 1200 can be used with the IRP. The patch antenna 1000 can include conductive traces 1004 located (e.g., printed, sprayed, or otherwise deposited) on a substrate 1002. The substrate 1202 can be made of a non-conductive, long-term biocompatible material such as liquid crystal polymer (LCP), polyimide, or polyamide. In some cases, another layer (or seed layer) can be located on the substrate 1202 to facilitate the adhesion of the conductive traces (this can also apply to the patch antenna 1000). Such a layer can be made of titanium. The substrate 1202 can be supported by spacers 1206 supported by a base 1208. The feed 1203 can connect the substrate antenna 1200 to an electronic circuit ( Fig.10 not shown in the figure), which can include transmit and receive circuitry. An antenna impedance matching circuit can connect the antenna feed 1203 and the transceiver. The substrate antenna 1200 can be referred to as a single-layer substrate antenna because the conductive traces are located on only one layer of the substrate 1202. In some embodiments, as described herein, the substrate antenna can include conductive traces located on multiple layers (e.g., top and bottom layers) of the substrate 1202.

[0205] The conductive traces can be arranged as a set of external traces 1210 and a set of internal traces 1212. The two sets of traces 1210 and 1212 can be connected at 1214. The set of internal traces 1212 can be connected to the feed section 1203 at a feed section point 1216 located at the center of the circle. The set of external traces (or outer ring) 1210 can include a plurality of petal-shaped portions that can be connected to each other. Similarly, the set of internal traces (or inner ring) 1212 can include a plurality of petal-shaped portions that can be connected to each other. Shaping the traces into a petal shape can result in a design in which the traces are symmetrically arranged around the feed section point 1216, which has been found to improve the characteristics of the substrate antenna 1200. The spacing of the petals in one or more sets of traces 1210 or 1212 affects the resonance of the substrate antenna 1200. For example, positioning the petals closer together can improve the resonance of the substrate antenna 1200 in one or more MICS or ISM frequency bands. Adding more petals to one or more sets of traces 1210 or 1212 can increase the electrical length of the substrate antenna 1200 and improve the resonance in one or more MICS or ISM frequency bands. Rounding the corners, such as corners shaped like a "V", can affect the resonance of the substrate antenna 1200. Although petal-shaped portions are shown in Fig.10 other symmetric (or asymmetric) shapes can also be used (e.g., as described in connection with Fig.18 ). For example, a zigzag pattern of traces can be used.

[0206] The substrate antenna 1200 can include a stub 1220, which can be a circular trace connected to a set of internal traces 1212. As described herein, changing the length of the stub 1220 can improve the performance of the substrate antenna 1200.

[0207] Although the substrate antenna 1200 is shown as a circular structure, in some embodiments, the antenna can be non-circular.

[0208] PIFA antenna

[0209] In some embodiments, the antenna 1030 can be a PIFA antenna. Figure 8 A PIFA antenna 1000 supported by a substrate 1002 is depicted. The PIFA antenna 1000 can include conductive traces 1004 located (e.g., printed, sprayed, or otherwise deposited) on the substrate 1002. The conductive traces 1004 can be made of a material (e.g., one or more of gold, silver, platinum, graphite, copper, etc.).) can be located on the substrate 1002. The material can be biocompatible. In some cases, the material can be conductive ink. The PIFA antenna 1000 can be a type of substrate antenna.

[0210] The substrate 1002 can be made of a non-conductive biocompatible material, such as liquid crystal polymer (LCP), polyimide, or polyamide, on which conductive traces can be located. The material can have long-term biocompatibility. The substrate 1002 can be supported by a spacer 1006 (or support), which can separate the trace 1004 from the housing 320 of the sensor assembly. The spacer 1006 can be made of a non-conductive material (such as a thermoplastic) and can be used as a spacer between the conductive material of the housing 320 and the conductive antenna trace to improve antenna performance. As described herein (e.g., in connection with block 406), changing the height of the spacer 1006 can affect the characteristics of the antenna 1000. To increase the electrical length of the phased antenna 1000 (such that the antenna can resonate in one or more desired frequency bands), the antenna trace can be wound around the spacer 1006, as Figure 8 shown. The spacer 1045 can be supported by a base 1047. The feed section ( Fig.10 not shown in Fig.10 ) can connect the phased antenna 1000 to an electronic circuit (

[0211] not shown in

[0212] ) that can include transmit and receive circuitry. An antenna impedance matching circuit can connect the antenna feed and the transceiver. Although the phased antenna 1000 is shown as a circular structure, in some embodiments, the antenna can be non-circular. Fig.14 An embodiment of a helical or spiral antenna is shown.

[0213] Clock and power management circuits

[0214] Referring Figure 8 and 9 , the clock and power management circuit 1020 can be configured to generate clock signals for one or more of the other components of the electronic assembly 1010 and can be configured to generate periodic commands or other signals (e.g., interrupt requests) in response to the controller 1032 causing one or more components of the implantable circuit to enter or exit a sleep or other low-power mode. The clock and power management circuit 1020 can also be configured to regulate the voltage from the battery 1012 and provide a regulated power supply voltage to some or all of the other components of the electronic assembly 1010.

[0215] Memory

[0216] Referring Figure 8 and 9, the memory 1024 can be any suitable non-volatile memory, such as EEPROM or FLASH memory, and can be configured to store data written by the controller 1032 and provide data in response to a read command from the control circuit.

[0217] switch

[0218] Reference Figure 8 and 9 , the switch 1016 can be configured to couple the battery 1012 to one or more measurement units 1022 or decouple the battery from the one or more measurement units in response to a control signal from the controller 1032. For example, the controller 1032 can be configured to generate a control signal with an open state that causes the switch 1016 to open and thus disconnect power from one or more measurement units 1022 during a sleep mode or other low-power mode to save power and thus extend the life of the battery 1012. Similarly, the controller 1032 can also be configured to generate a control signal with a closed state when "waking up" from the sleep mode or otherwise exiting another low-power mode, and the closed state causes the switch 1016 to close and thus couple power to one or more measurement units 1022. This low-power mode can be used only for one or more measurement units 1022 or for the measurement units of the electronic component 1010 and one or more other components.

[0219] The switch 1018 can be configured to couple the battery 1012 to the memory 1024 or decouple the battery from the memory 1024 in response to a control signal from the controller 1032. For example, the controller 1032 can be configured to generate a control signal with an open state that causes the switch 1018 to open and thus disconnect power from the memory 1024 during a sleep mode or other low-power mode to save power and thus extend the life of the battery 1012. Similarly, the controller 1032 can also be configured to generate a control signal with a closed state when "waking up" from the sleep mode or otherwise exiting another low-power mode, and the closed state causes the switch 1018 to close and thus couple power to the memory 1024. This low-power mode can be used only for the memory 1024 or for the memory and one or more other components of the electronic component 1010.

[0220] power supply

[0221] Battery

[0222] The intelligent implant will optionally have a power source required to operate the electronics within the IRP, which measures, records, and transmits data regarding the status of the implant. Some medical implants already have a power source. In some embodiments, this power source is in the form of a battery.

[0223] The power curve of the electronic circuitry of the implantable report processor can be configured such that the battery has a desired expected lifetime suitable for the type of prosthesis (or other device) associated with the battery. For example, such a desired expected lifetime can be in the range of 1 to 15+ years, such as 10 years. In some embodiments, the battery is configured to power the electronic circuitry of the IRP throughout the expected lifetime (e.g., 18+ years) of the IPR. Embodiments of such circuitry include: a supply node configured to couple to the battery; at least one peripheral circuit; a processing circuit coupled to the supply node and configured to couple the at least one peripheral circuit to the supply node; and a timing circuit coupled to the supply node and configured to activate the processing circuit at a set time or times.

[0224] Utilizing its LiCFx chemistry, the battery can provide approximately 360 milliampere-hours (mAh) at 3.7 volts (V) over its lifetime, but for each 5 mm length added to the battery, this output can be increased by approximately 36 mAh (similarly, for each 5 mm length subtracted from the battery, this output can be decreased by approximately 36 mAh). It should be understood that other battery chemistries can be used depending on the size and lifetime requirements of the application if they can meet the appropriate power requirements of a given 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 iodide, and hybrid types consisting of combinations of the above chemistries, such as CFx-SVO.

[0225] Replacing the power source implanted in a patient is generally undesirable, at least because it involves an invasive procedure that can be relatively expensive and may have adverse side effects, such as infection and pain. Thus, the implantable report process (IRP) can include a power source (e.g., a battery) and a mechanism for managing the power output of the implanted power source such that the power source will provide power for a sufficient period of time regardless of the location of the power source within the patient. The IRP can include the only power source present in the intelligent implant.

[0226] The battery can be disposed directly within the prosthesis or can be configured to be disposed within a portion of the implantable report processor. Alternatively, the battery can be configured for placement within a living area other than the intelligent implant.

[0227] Extending Battery Life

[0228] The intelligent implant 1002 can operate in various modes to detect different types of movement. In this way, when a predetermined type of movement is detected, the intelligent implant 1002 can increase, decrease, or otherwise control the amount and type of kinematic data and other data collected.

[0229] In one example, the intelligent implant 1002 can determine whether a patient is moving. The implantable device 1002 can start storing data in the memory 10 seconds after determining that movement has occurred. In response to this determination, the amount and type of data collected can be started, stopped, increased, decreased, or otherwise appropriately controlled. The intelligent implant 1002 can further control data collection based on certain conditions, such as when the patient stops moving, when the selected maximum amount of data is collected for the collection process, when the intelligent implant 1002 times out, or based on other conditions. After collecting data in a particular session, the intelligent implant 1002 can stop collecting data until the next day, when the patient moves next, after the previously collected data is offloaded (e.g., by transmitting the collected data to the home base station 1004), or according to one or more other conditions.

[0230] In some embodiments, referring to Fig. 9 , the IRP 1003 of the intelligent implant can be configured to be placed in different operating modes. These modes can include, for example: deep sleep mode, standby mode, low resolution mode, medium resolution mode, and / or high resolution mode.

[0231] Deep sleep mode. During the deep sleep mode, the IRP 1003 is in an ultra-low power state during storage to maintain the shelf life before implantation. In this mode, only the clock and power management circuit 1020 and the RF transceiver 1026 wake-up circuit are active. For this purpose and referring to Fig. 9 , the battery 1012 supplies power to the clock and power management circuit 1020, and the RF transceiver 1026 and switches 1016, 1017, 1018 are turned on to disconnect the battery 1012 from the IMU 1022, accelerometer 1023, and memory 1024.

[0232] Standby mode. During the standby mode, the IRP 1003 can be placed in a low power state, during which the implant is ready for wireless communication with an external device.

[0233] Low resolution mode.During the low-resolution mode, the IRP 1003 collects low-resolution linear acceleration data for the detection and counting of simple motion events and the detection of significant motion. In some embodiments, the low-resolution mode is characterized by activating a first set of sensors (e.g., the discrete accelerometer 1023 of the IMU 1022 or one or more accelerometers) that enables 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 Fig. 9 , one of the switches 1016, 1017 is closed to connect the battery 1012 to the IMU 1022 or the discrete accelerometer 1023. When in the low-resolution mode, the first set of sensors counts simple motion events and sends a significant motion notification to the controller 1032. In some examples, when exiting the low-resolution mode, the IMU 1022 or the discrete accelerometer 1023 reports the count of simple motion events to the controller 1032. The low-resolution mode can be entered at a scheduled time and exited at a scheduled time according to a sampling schedule. During the low-resolution mode, the first set of sensors continuously collects data.

[0234] Medium resolution mode. When in the medium-resolution mode, the IRP 1003 collects both linear acceleration and rotational motion data. In some embodiments, the medium-resolution mode is characterized by activating a second set of sensors (e.g., the three accelerometers and three gyroscopes of the IMU 1022) that can detect linear acceleration and rotational speed using a sampling rate in the range of 12 Hz to 100 Hz. To this end and with reference to Fig. 9 , the switch 1016 is closed to connect the battery 1012 to the IMU 1022. In some examples, the medium-resolution mode can 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 wirelessly sent from an external device, such as a base station. The medium-resolution mode can be exited after a predetermined event related to the detected significant motion.

[0235] High resolution mode.In some embodiments, when in high-resolution mode, the IRP 1003 can collect linear acceleration data, or it can collect both linear acceleration and rotational motion data, or it can collect ultrasonic data, or it can collect a combination of all the modalities indicated. In some embodiments, the high-resolution mode is characterized by activating a third set of sensors (e.g., the three accelerometers of the IMU 1022 when only collecting acceleration data or the three accelerometers and three gyroscopes of the IMU when collecting acceleration and rotational motion data), which are capable of detecting acceleration and rotational motion data using a sampling rate in the range of 200 Hz to 5000 Hz. In some embodiments, the high-resolution mode is characterized by activating an ultrasonic sensor to detect the implantation location using a sampling rate in the range of 200 Hz to 20,000 Hz. To this end and with reference to Fig. 9 , switch 1016 is closed to connect the battery 1012 to the IMU 1022. In some examples, the high-resolution mode can be initiated when a specified detection of a significant motion event occurs during the medium-resolution window of the day's configuration, or by a manual command wirelessly sent from an external device. The high-resolution mode can have a built-in time limit after which the acquisition automatically terminates.

[0236] One or more of these modes can be used to passively and autonomously collect data at different frequencies during the lifetime of the smart implant without patient involvement. The smart implant can start collecting data on the second day after surgery and is capable of storing up to 30 days of data in its memory. Thereafter, the data is transmitted to the cloud every day. In some examples, if data cannot be transmitted due to connection problems with the base station and the implant has reached its memory limit, the new data will overwrite the oldest data. Additionally, if the base station cannot connect to the cloud but is still able to communicate with the implant locally, it can store up to 45 days of transmitted data.

[0237] In some embodiments, the smart implant 1002 can include a fourth set of sensors (e.g., a fourth accelerometer on the IMU 1022) located on a separate board or circuit (not shown). In some instances, this separate board or circuit can receive power independently of the power supply to the smart implant 1002 / IMU 1022 that includes the three sets of sensors. In some embodiments, this allows power to be supplied to one accelerometer to detect whether the patient is walking without having to supply power to the entire smart implant 1002 / IMU 1022 just for detecting whether the patient is walking.

[0238] Control circuit / controller / processor

[0239] A processor, which can be any suitable microcontroller or microprocessor, can be configured to control the configuration and operation of one or more other components of the sensor assembly 300. For example, the processor can be configured to control one or more sensors to sense relevant measurement data or physiological parameters, store the measurement data generated by one or more sensors in a memory, generate a message including the stored data as a payload, packetize the message, and provide the message packet to the antenna 312 for transmission to a receiver (e.g., a hub inside the patient or a base station or other computing device outside the patient). The controller 1032 can also be configured to execute commands received from a base station (not shown) via the antenna 1030, the filter 1028, and the RF transceiver 1026. For example, the processor can be configured to receive configuration data from the base station and provide the configuration data to the component of the sensor assembly 300 to which the base station directs the configuration data. If the base station directs the configuration data to the controller 1032, the control circuit is configured to configure itself in response to the configuration data.

[0240] IRP Operations

[0241] Still referring to Figure 8 and Fig. 9 the operation of an implantable report processor (IRP) is described with respect to an implantable smart implant in which an IRP is provided or otherwise associated with the IRP.

[0242] The normally electrically closed fuse 1014 is configured to electrically open in response to an event that, if it persists for longer than a safe time length, could harm the patient in which the electronic component 1010 is located or damage the battery 1012 of the implantable circuit. Events in response to which the fuse 1014 can electrically open include overcurrent conditions, overvoltage conditions, overtemperature conditions, overcurrent-time conditions, overvoltage-time conditions, and overtemperature-time conditions. An overcurrent condition occurs in response to the current passing through the fuse 1014 exceeding an overcurrent threshold. Similarly, an overvoltage condition occurs in response to the voltage across the fuse 1014 exceeding an overvoltage threshold, and an overtemperature condition occurs in response to the temperature of the fuse exceeding a temperature threshold. An overcurrent state occurs in response to the integral of the current passing through the fuse 1014 over a measurement time window (e.g., ten seconds), where the window can "slide forward" in time such that the window always extends for the length of the window in time units starting from the current time. Alternatively, an overcurrent state occurs if the current passing through the fuse 1014 exceeds the overcurrent threshold for a threshold time. Similarly, an overvoltage-time condition occurs in response to the integral of the voltage across the fuse 1014 within a measurement time window, and an overtemperature-time condition occurs in response to the integral of the temperature of the fuse within a measurement time window. Alternatively, an overvoltage-time condition occurs if the voltage across the fuse 1014 exceeds the overvoltage threshold for a threshold time, and an overtemperature-time condition occurs if the temperature associated with the fuse 1014, battery 1012, or electronic component 1010 exceeds the overtemperature threshold for a threshold time. However, even if the fuse 1014 opens and thus power is disconnected from the electronic component 1010, the mechanical and structural components of the smart implant ( Figure 8 not shown) remain fully operational.

[0243] The processor can cause one or more sensors to make measurements, detect, determine whether the measured values are qualified or valid measured values, store data representative of the valid measured values, and cause the antenna 312 to transmit the stored data to a base station or other source external to the sensor assembly 300.

[0244] Still referring to Figure 8 and Fig. 9 , in response to being polled by a base station (not shown) or by another device external to the implant device, the controller 1032 can generate a conventional message having a payload and a header. The payload includes stored samples of signals generated by one or more measurement units 1022, and the header includes a partition of the samples in the payload, a timestamp indicating the time at which the measurement unit 1022 acquired the samples, an identifier of the implantable prosthesis (e.g., serial number), and a patient identifier (e.g., number or name).

[0245] The processor may generate data packets including messages according to conventional packetization protocols. Each packet may also include a packet header that includes, for example, a sequence number of the packet, such that a receiving device can correctly order the packets even if the packets are transmitted or received out of order.

[0246] The processor may encrypt some or all parts of each data packet according to, for example, conventional encryption algorithms, and error-code the encrypted data packets. For example, the processor may encrypt at least the sensor component 300 and the patient identifier to make the data packets compliant with the Health Insurance Portability and Accountability Act (“HIPAA”).

[0247] The processor may provide the encrypted and error-coded data packets to the antenna 312, which sends the data packets to a destination, such as the base station 4 (shown in FIG. 1) or a receiver external to the sensor system, through a filter. The antenna 312 may send the data packets according to any suitable data packet transmission protocol.

[0248] Still referring Figure 8 and Fig. 9 , alternative embodiments of the electronic component 1010 are envisioned. For example, the antenna 312 may perform encryption or error coding instead of or as a supplement to the processor. Additionally, one or both of the switches 1016 and 1018 may be omitted from the electronic component 1010. Further, the sensor component 300 may include components in addition to those described herein and may omit one or more of the components described herein.

[0249] Base Station

[0250] Fig.15 An embodiment of a base station circuit 1040 configured to be included within or otherwise used with a base station, such as Figure 7 the home base station 1004, is configured to communicate with Figure 8 or Fig. 9 the electronic component 1010 is shown.

[0251] Configure

[0252] In some embodiments, the base station circuit 1040 is powered by a power supply 1042 and includes a first antenna 1044 and a second antenna 1046, a first RF filter 1048 and a second RF filter 1050, a first RF transceiver 1052 and a second RF transceiver 1054, a memory 1056, and a base station control circuit 1058.

[0253] As discussed above, power source 1042 can be any suitable power source, such as a battery or a power source that receives power from an electrical outlet; if the power source is of the latter type, the power source may also include a backup battery for power outage, or include a backup battery when the base station circuit 1040 is "unplugged".

[0254] Antenna 1044 can be any antenna suitable for the frequency band in which the RF transceiver 1052 communicates with Figure 8 the electronic component 1010 of FIG. 7 or 9. Similarly, antenna 1046 can be any antenna suitable for the frequency band in which the RF transceiver 1054 communicates with components of the home network 1006 of FIG. 1, such as a router, access point, or repeater.

[0255] The filter can be any suitable bandpass filter, such as a surface acoustic wave ("SAW") filter or a bulk acoustic wave ("BAW") filter.

[0256] RF transceiver 1052 can be a transceiver configured to allow the control circuit 1058 to communicate with Figure 8 the electronic component 1010 of FIG. 7 or 9 when the implant circuit is disposed within or otherwise associated with the smart implant 1002 of FIG. 1. For example, antenna 112 can be any suitable type of transceiver (e.g., low energy (BTLE) and ), and can be configured to operate according to any suitable protocol (e.g., MICS, ISM, low energy (BTLE), Zigbee, and ), and can be configured to operate in the range of 1 MHz - 5.4 or a suitable range.

[0257] Similarly, RF transceiver 1054 can be a transceiver configured to allow the control circuit 1058 to communicate with Figure 7 components of the home network 1006, such as a router, access point, or repeater, or communicate with one or more of the home base station 1004, smart device 1005, and connected personal assistant 1007 of FIG. 1. For example, antenna 112 can be any suitable type of transceiver (e.g., low energy (BTLE) and ), and can be configured to operate according to any suitable protocol (e.g., MICS, ISM, low energy (BTLE), Zigbee, and ), and can be configured to operate in the range of 1 MHz - 5.4 or a suitable range.

[0258] Memory 1056 can be any suitable non-volatile memory, such as EEPROM or FLASH memory, and can be configured to store data written by control circuit 1058 and provide data in response to a read command from the control circuit. For example, control circuit 1058 can store in memory 1056 data packets received from Fig.15 electronic component 1010, and can store data packets received from the cloud server via RF transceiver 1054, where the data packets include, for example, Figure 8 commands, instructions, or configuration data of electronic component 1010 such as

[0259] or 9. Alternatively, memory 1056 can include volatile memory. Figure 8 or 9. A processor, which can be any suitable microcontroller or microprocessor, can be configured to control the configuration and operation of one or more other components of sensor assembly 300. For example, base station control circuit 1058 can be configured to receive data packets from Figure 7 electronic component 1010 such as Figure 8 or 9 via RF transceiver 1052, convert the received data packets into data packets suitable for transmission to

[0260] home network 1006, and transmit the converted data packets to the home network via RF transceiver 1054. And base station control circuit 1058 can also be configured to receive data packets from home network 1006 via RF transceiver 1054, convert the received data packets into data packets suitable for transmission to Fig.15 electronic component 1010 such as

[0261] or 9, and transmit the converted data packets to the implantable circuit via RF transceiver 1052. Figure 8 or 9), for example, once a day, once every other day, once a week, or once a month. If control circuit 1058 does not receive a response to the poll, the control circuit can poll electronic component 1010 more frequently (e.g., every 5 minutes, every 30 minutes, every hour) until it receives a response or determines that the implanted prosthesis is out of range of the base station.

[0262] Electronic component 1010 ( Figure 8 or 9) responds to the poll by transmitting all sample data packets of one or more measurement units 1022 of electronic component 1010 generated since the last data packet transmission.

[0263] The antenna RF transceiver 1052 receives data packets from the electronic component 1010 ( Figure 8 or 9) via the antenna 1044 and the filter 1048, and provides the received data packets to the base station control circuit 1058. The base station control circuit 1058 decodes and decrypts the data packets, parses the messages from the data packets, and stores the parsed messages in the memory 1056. Before storing the parsed messages, the base station control circuit 1058 may encrypt a portion of all the parsed messages to comply with HIPAA.

[0264] Then, the base station control circuit 1058 reformats the stored messages or generates new messages in response to the headers and payloads of the stored messages. For example, the base station control circuit 1058 may generate new messages each including a corresponding payload and header from the received messages, but each including additional header information such as the identifier of the base station 1004 ( Figure 8 or 9), the time when the original message was received from the electronic component 1010 ( Figure 8 or 9), and the time when the new message was generated. Before generating the new messages, the base station control circuit 1058 may decrypt the parsed messages stored in the memory 1056.

[0265] Then, the base station control circuit 1058 may generate data packets including the new messages, encrypt some or all of the data packets, and error-code the data packets, and provide the encrypted and coded data packets to the RF transceiver 1054. The RF transceiver 1054 transmits the encrypted and coded data packets to the home network 1006 via the filter 1050 and the antenna 1046. Before providing the data packets to the RF transceiver 1054, the base station control circuit 1058 may temporarily store the encrypted and coded data packets in the memory 1056 (e.g., stored in a buffer).

[0266] In an alternative embodiment, the base station control circuit 1058 "passes" the data packets received from the electronic component 1010 ( Figure 8 or 9) to the home network 1006 ( Figure 7 ). That is, the base station control circuit 1058 receives one or more data packets from the electronic component 1010 via the RF transceiver 1052, temporarily stores the one or more data packets in the memory 1056, and causes the RF transceiver 1054 to transmit the one or more data packets to the home network 1006.

[0267] In yet another alternative, the control circuit 1058 modifies one or more data packets received from the electronic component 1010 ( Figure 8 or 9) without first parsing the one or more data packets, or parsing some but not all of each data packet.

[0268] The home network 1006 ( Figure 7 ) can "deliver" one or more data packets received from base station 1004 to a destination, such as a server on cloud 1008 Figure 7 ), or can modify one or more data packets according to a suitable communication protocol before sending the one or more data packets to the destination.

[0269] Notwithstanding the above, it should be appreciated that any device (e.g., a smart phone, a home computer, a tablet, a wearable device, etc.) can be used as a home base station to perform any one or more of the base station functions described herein. For example, the device can be any device with a customized application that allows the functions required for secure communication, data transfer, storage, and delivery of the smart implant, thus allowing secure data transfer to a cloud-based data storage and analysis system for the smart implant. The device can have compatible wireless communication protocols and circuitry, such as but not limited to cellular, Wi-Fi, Zigbee, Bluetooth, or BTLF technology.

[0270] Clinical Application

[0271] The following disclosure focuses on spinal fusion by implanting an interbody spacer or spinal cage; however, the present disclosure is more generally applicable to any medical implant as disclosed herein. Currently, postoperative, in-hospital spinal fusion surgery monitoring is performed through personal visits by hospital staff and the medical team, physical examinations of the patient, medical monitoring (vital signs, etc.), range of motion assessment (ROM), physical therapy (including early mobilization and activity), and diagnostic imaging studies and blood tests as needed. Once the patient is discharged from the hospital, patient satisfaction is checked during regular doctor's office visits, where a comprehensive history, physical examination, and complementary imaging and diagnostic studies are used to monitor the patient's progress and determine the development of any potential complications. During such visits, the surgeon typically assesses the patient's range of motion, attempts to identify any pain that occurs during certain movements or actions, and asks the patient to determine activity level, daily function, pain control, and rehabilitation progress.

[0272] Unfortunately, much of the patient's recovery period occurs between hospital and / or clinic visits. As such, it may be difficult to accurately measure and follow full range of motion (ROM may vary depending on pain control, level of anti-inflammatory medications, time of day, recent activities, and / or how the patient feels at the time of examination), patient activity levels, exercise tolerance, and the effectiveness of rehabilitation efforts (physical therapy, medications, etc.) from the day of surgery to full recovery. For much of this information, doctors rely on patient self-reporting or third-party observation to gain insights into the effectiveness of post-operative treatment and the progress of recovery and rehabilitation; in many cases, this is further complicated because patients are unsure what to look for, do not know what "normal / expected" post-operative recovery should be, are non-compliant, or are unable to effectively communicate their symptoms. Additionally, identifying and tracking complications (both within and outside the hospital) before they become symptomatic, between doctor visits, or those that are difficult for the patient (and / or doctor) to detect will also provide useful additional information for the management of the patient's recovery. Currently, in all cases, doctors and patients do not have access to the type of "real-time", continuous, objective, prosthetic performance measurements that they may otherwise wish to make.

[0273] The IMU of the active implant of the present disclosure can provide the surgeon with an accurate, digital, quantitative range of motion data; the data can be compared to expected values to evaluate the efficacy of the post-operative procedure, and can be used as a baseline value to compare to functional values obtained after surgery. Any abnormalities in vibration (e.g., micromovements that may indicate the likelihood of fusion), rotation (e.g., stiffness of the patient that can identify whether fusion has occurred), and acceleration (e.g., that can determine patient movement, such as walking speed) can be monitored, and clinicians can utilize this data to provide optimal patient care.

[0274] Shortly after implantation of a spinal fusion and lumbar interbody spacer or cage, and after an appropriate post-operative recovery period, the implant begins to measure the patient's movement to determine quality of life measurements. This can include, for example, step count, cadence, average walking speed, mass / angle center, and / or flexion. An accelerometer can measure and track movement of the spine during movement. As the patient continues to improve their range of motion post-operatively, the acceleration experienced at different locations along the spine (e.g., lumbar, thoracic, cervical) can be monitored. It is expected that as the patient heals from surgery, activity levels will gradually increase, and movement will improve and increase. The effects of movement and various activities can be monitored by various accelerometers and compared to the patient's subjective experience to determine which life activities are improving (or inhibiting) post-operative recovery and rehabilitation.

[0275] Integrating data collected by the sensors described herein (e.g., accelerometers and gyroscopes) with widely available commercial analytics techniques, such as pedometers, allows for the collection of additional clinically important data, such as, but not limited to: patient activity levels (activity frequency, duration, intensity), exercise tolerance (work, calories, power, training effect), range of motion under various “real-world” conditions (discussed elsewhere herein), and prosthetic performance. It is difficult to overstate the value of this information in achieving better management of patient recovery. The attending physician (or physical therapist, rehabilitation specialist) observes the patient only during scheduled visits; the degree of patient function at the exact moment of the examination can be affected by a variety of different factors, such as: the presence or absence of pain, the presence or absence of inflammation, stiffness, time compliance, and the timing of medication use (painkillers, anti-inflammatory drugs), recent activity and exercise levels, patient strength, mental state, language barriers, the nature of their doctor-patient relationship, and even the patient's ability to accurately express symptoms – to name just a few. Continuous monitoring and data collection can allow patients and doctors to objectively monitor progress by providing objective information about patient function under many conditions and circumstances, to evaluate the impact of various interventions (pain control, exercise, physical therapy, anti-inflammatory drugs, rest, etc.) on performance, and to compare rehabilitation progress to previous function and future expected function. When both doctors and patients benefit from observing the impact of various treatment modalities on patient recovery, activity, function, and overall performance, better treatment decisions and better patient compliance can be expected.

[0276] The goal of the smart implant included herein is to provide an improvement in the patient's quality of life, to address the cause of pain (e.g., multi-focal and radial), and to facilitate pain management. The patient's medical condition can be determined directly and / or indirectly. As described above, an indirect measurement of the patient's medical condition can be determined by considering the patient's quality of life. For example, a doctor can consider whether the patient's movement has increased or decreased over time; whether the patient is able to return to a previously enjoyed activity (e.g., exercise, cooking, entertainment); whether the patient is able to continue to take care of themselves or maintain independence; and so on. Each of these examples can be determined from the raw data generated by the accelerometer and gyroscope on the implantable reporting processor. This raw data can be stored and uploaded to the cloud, where the data is used to determine the patient's movement, which includes, for example, step counting, cadence, average walking speed, the patient's center of mass, etc.

[0277] In some embodiments, when indirect measurement and calculation of kinematic data are completed under excitation (e.g., loading and moving), the intelligent implant can determine the patient's baseline motion (e.g., when the patient is static) to be used as a normative reference. This normative reference can be used to determine the patient's relative reference (e.g., the speed at which the patient returns to regular activities). In some embodiments, the patient's normative reference can be determined by calibrating the patient after surgery (e.g., spinal fusion) is completed. In some examples, a demarcation is performed to set the reference at a known position. This can be, for example, when the patient is against a wall or in a known position (e.g., when the patient's back is straight or at a predetermined angle).

[0278] In addition to monitoring the patient's kinematic information, the smart implant can also monitor other data points that can indicate potential patient discomfort or problems during recovery. For example, sensors within the smart implant can monitor the patient's posture. In some embodiments, the smart implant can be configured to monitor the range of motion (ROM) at the fusion point (e.g., lumbar ROM, cervical ROM, thoracic ROM). In some examples, the smart implant can detect whether the screws of the implant are loose. As will be discussed in more detail below, the smart implant will determine by direct and indirect measurements whether inter-body fusion has occurred, whether the inter-body spacer has migrated, and / or whether the smart implant has been implanted with segment regression.

[0279] In some embodiments, indirect measurement of patient improvement can be accomplished by measuring fusion, migration, and subsidence of the smart implant.Inertial measurement motion can be used to generate kinematic data to measure the amount of fusion, migration, and / or subsidence of the smart implant.

[0280] Fusion. When an interbody spacer or cage is press-fit into the space between two adjacent vertebrae, fusion measures the amount of micromotion in the interbody spacer or cage to determine whether the two adjacent vertebrae have fused. If micromotion is detected, it indicates to the doctor that the patient's vertebrae have not fully fused.

[0281] migrate. Migration determines the amount of translation of an interbody spacer or spinal cage positioned between the vertebrae from its initial implanted position. In some embodiments, an inertial measurement unit on an implantable reporting processor can determine the patient's step count, cadence, average walking speed, angle of motion, etc. As discussed above, an increase and / or decrease in the migration of a smart implant (i.e., an interbody spacer or spinal cage) can indirectly indicate whether the patient's condition is improving. For example, the patient's movement is decreasing, or the angle of movement or cadence changes, which can indicate to the physician that the patient is in pain, which may be due to migration of the implant and resulting loss of spacing between the associated vertebrae.

[0282] Assumption.Prior to complete fusion, there is a decrease in the vertical height of the disc space measured by settlement. The lateral position is an important consideration because a decrease in the disc space between adjacent vertebrae can adversely affect mechanical correction and clinical outcomes. Since the bone consistency of the patient can vary and / or the amount of host site bone preparation by the doctor is variable, the potential amount of regression experienced by the patient can vary after spinal fusion. In some embodiments, changes in the patient's gait detected by the inertial measurement unit can be associated with pain caused by a decrease in intervertebral height and associated nerve compression. This can indicate to the doctor that regression has occurred. In such a case, the doctor will call the patient for a direct imaging study for a final diagnosis.

[0283] In addition to indirect measurements, the presently disclosed intelligent implant can be used to provide direct measurements of the migration and subsidence of an interbody spacer or spinal cage. As shown in FIGS. 1A-1C, 2A-2D, and 3 provided herein, an implantable reporting processor (e.g., implantable reporting processors 150, 250) can include a plurality of sensors positioned on the top surface, bottom surface, medial surface, and lateral surface to directly measure the movement of the interbody spacer or spinal cage.

[0284] migrate. As described above, migration measures the movement of the interbody spacer or spinal cage. In some embodiments, at least one ultrasonic sensor positioned on the medial surface of the barrel can scan the medial and lateral sides of the interbody spacer or vertebral cage to measure the amount of movement that the interbody spacer or vertebral cage is undergoing from its initial implanted position. In some embodiments, the migration of the interbody space or spinal cage can be measured by angle detection (e.g., by an inclinometer). When the patient is in a known position, the migration can be determined by sampling data of the position of the interbody spacer or spinal cage. For example, when the patient is sitting in a chair or standing during a doctor's office visit, the doctor can measure the migration. Alternatively, the position of the interbody spacer or spinal cage can be measured while the patient is in a known position (e.g., at night while the patient is asleep). In some embodiments, a gyroscope can assist in determining the orientation of the interbody spacer or spinal cage.

[0285] Assumption. As described above, subsidence measures the vertical height of the disc. In some embodiments, at least one ultrasonic sensor positioned on the top and bottom surfaces of the barrel can be used to directly measure the position of the bone above and below the interbody spacer or spinal cage. Any change in the distance between adjacent vertebrae and the surface of the interbody spacer or vertebral cage from the distance measured at the time of implantation can indicate to the doctor that the height of the vertebral disc has decreased and regression has occurred.

[0286] As described above, the smart implant can be used as a diagnostic tool to help doctors understand the success of spinal fusion. For example, indirect and direct determination of the fusion, migration, and resorption of interbody spacers or spinal cages can provide data to doctors to help diagnose the source of discomfort or pain in patients after spinal fusion. The information provided by the smart implant can help patients with pain management and / or resuming normal activities.

[0287] Disclaimer

[0288] The devices, methods, systems, etc. of the present disclosure have been described herein broadly and generally. Each of the narrower species and sub-generic groupings falling within the general scope of the present disclosure also forms part of the present disclosure. This includes the general description of the devices, methods, systems, etc. of the present disclosure, with the proviso or negative limitation of removing any subject matter, regardless of whether the excised material is specifically recited herein.

[0289] As used herein, the relative terms "medial", "lateral", "anterior", and "posterior" shall be defined from the perspective of the device and not necessarily the anatomical structure. For example, a sensor on the "lateral" end can anatomically face the posterior direction to detect anterior migration.

[0290] It should also be understood that, as used herein and in the appended claims, the singular forms "a", "an", and "the" include plural references, and the term "X and / or Y" means "X" or "Y" or both "X" and "Y" unless the context clearly indicates otherwise, and the letter "s" following a noun means both the plural and singular forms of that noun. Additionally, in the case where features or aspects of the present disclosure are described in terms of a Markush group, it is contemplated and will be recognized by those skilled in the art that the present disclosure encompasses and is thus also described in terms of any individual member of the Markush group and any subgroup of members, and the applicant reserves the right to amend the application or claims to specifically refer to any individual member or any subgroup of members of the Markush group.

[0291] It should be understood that the terms used herein are for the purpose of describing particular embodiments only and are not intended to be limiting. It should also be understood that, unless specifically defined herein, the terms used herein will be given their conventional meanings as known in the relevant art.

[0292] 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, in one or more embodiments, the particular features, structures, or characteristics may be combined in any suitable manner.

[0293] 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 context clearly dictates otherwise. For example, the term "sensor" refers to one or more sensors, and the term "medical device including a sensor" refers to a medical device including at least one sensor. A plurality of sensors refers to more than one sensor. It should also be noted that, in the broadest sense, the terms "and" and "or" are generally used to include "and / or", unless the context clearly requires otherwise to be inclusive or exclusive as the case may be. Thus, the use of an alternative (e.g., "or") should be understood to mean one, two, or any combination of the alternatives. Additionally, when expressed as "and / or" herein, the combination of "and" and "or" is intended to cover embodiments that include all relevant items or ideas and one or more other alternative embodiments that include less than all relevant items or ideas.

[0294] Unless the context requires otherwise, throughout the specification and the subsequent claims, the word "comprise" and its synonyms and variations, such as "have" and "include", and its variants such as "comprises" and "comprising" are to be interpreted 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 those that do not materially affect the basic and novel characteristics of the claimed invention. The term "consisting essentially of" limits the scope of the claims to the specified materials or steps, or to those materials or steps that do not substantially affect the basic and novel characteristics of the invention claimed.

[0295] Any headings used in this document are only for expediting the reader's review thereof and should not be construed as limiting the invention or the claims in any way. Accordingly, the headings and abstracts of the present disclosure provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.

[0296] Where a range of values is provided herein, it is to be understood that, unless the context clearly dictates otherwise, each intervening value to one-tenth of the unit of the lower limit is covered within the invention between the upper and lower limits of that range and any other stated or intervening value in that range. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges and are also covered within the invention, subject to any specific excluded limit values in the range. When the range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.

[0297] For example, unless otherwise specified, any concentration range, percentage range, ratio range, or integer range provided herein shall be understood to include any integral value within the stated range and, where appropriate, fractions thereof (e.g., one-tenth and one-hundredth of an integer). Additionally, unless otherwise specified, any number range recited herein relating to any physical property, such as polymer subunits, size, or thickness, shall be understood to include any integer within the stated range. As used herein, unless otherwise indicated, the term "about" means ±20% of the indicated range, value, or structure.

[0298] All U.S. patents, U.S. patent application publications, U.S. patent applications, foreign patents, foreign patent applications, foreign patent publications, and non-patent publications mentioned in and / or listed in the application data sheet are hereby incorporated by reference in their entirety. For the purposes of describing and disclosing, for example, the materials and methods described in the publications, these documents may be incorporated by reference and may be used in conjunction with the present disclosure. The publications discussed above and throughout the text are provided only for the purpose of being publicly available prior to the filing date of the present application. Nothing herein shall be construed as an admission that the inventors are not entitled to antedate any of the cited publications based on prior invention.

[0299] All patents, publications, scientific articles, websites, and other documents and materials referenced or mentioned herein indicate the level of skill of those of ordinary skill in the art to which the present invention pertains, and each such referenced document and material is hereby incorporated by reference to the same extent as if incorporated by reference in its entirety or set forth in full text. The applicant reserves the right to physically incorporate any and all materials and information from any such patents, publications, scientific articles, websites, electronically available information, and other reference materials or documents into the present specification.

[0300] Generally, in the appended claims, the terms used should not be construed as limiting the claims to the specific embodiments disclosed in the specification and claims, but should be construed to include all possible embodiments and the full scope of equivalents to which such claims are entitled. Thus, the claims are not limited by the present disclosure.

[0301] Furthermore, the written description portion of this patent includes all of the claims. Additionally, all claims, including all original claims and 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 the applicant reserves the right to physically incorporate any and all such claims into the written description or any other part of the application. Thus, for example, in no case may a patent be construed as claiming that there is no written description of a claim, i.e., that the written description portion of the patent does not set forth the exact wording of the claim in haec verba.

[0302] The litigation will be interpreted according to law. However, notwithstanding any claim or perception of ease or difficulty in interpreting any claim or portion thereof, in no event shall any adjustment or amendment of any claim or any portion thereof during the examination of the application leading to this patent be construed as having forfeited any right to any and all equivalents that are not part of the prior art.

[0303] Other non-limiting embodiments are within the following claims. The patent may not be construed as limited to the specific examples or non-limiting embodiments or methods specifically and / or expressly disclosed herein. In no event shall the patent be construed as being limited by any statement of any examiner or any other officer or employee of the Patent and Trademark Office, unless such statement is clear and unqualified or unreserved and is expressly adopted by the applicant in a responsive writing.

[0304] Generally, in the appended claims, the terms used should not be construed as limiting the claims to the specific embodiments disclosed in the specification and claims, but should be construed as including all possible embodiments and the full scope of equivalents to which such claims are entitled. For example, described embodiments having one or more omitted components or steps may be additional embodiments contemplated and covered by this application.

[0305] Example Embodiments

[0306] Embodiment 1: An implantable sensor assembly for use during spinal fusion, the implantable sensor assembly comprising:

[0307] a component of an implantable prosthesis; and

[0308] an implantable cannula associated with the component, the implantable cannula comprising:

[0309] at least one sensor capable of detecting one or more kinematic measurements associated with a patient and generating sensor data, and

[0310] an antenna in electrical communication with the at least one sensor, wherein the antenna transmits the sensor data to a receiver at a remote location.

[0311] Embodiment 2: The implantable sensor assembly according to Embodiment 1, wherein the implantable cannula further comprises a battery.

[0312] Embodiment 3: The implantable sensor assembly according to Embodiment 1, wherein the implantable cannula further comprises an inertial measurement unit having a plurality of accelerometers and / or a plurality of gyroscopes.

[0313] Embodiment 4:The implantable sensor assembly according to Embodiment 3, wherein the inertial measurement unit comprises:

[0314] A first accelerometer and / or a first gyroscope for measuring data associated with a first measurement axis,

[0315] A second accelerometer and / or a second gyroscope for measuring data associated with a second measurement axis, and

[0316] A third accelerometer and / or a third gyroscope for measuring data associated with a third measurement axis.

[0317] Embodiment 5: The implantable sensor assembly according to Embodiment 1, wherein the implantable cylinder has a length that combines a circular, elliptical, square, or rectangular cross-section.

[0318] Embodiment 6: The implantable sensor assembly according to Embodiment 1, wherein the implantable cylinder has a cross-section that has a corner radius associated with a square or rectangular cross-section.

[0319] Embodiment 7: The implantable sensor assembly according to Embodiment 1, wherein the implantable cylinder is positioned within the component.

[0320] Embodiment 8: The implantable sensor assembly according to Embodiment 1, wherein the implantable cylinder is insertable into a slot of the component.

[0321] Embodiment 9: The implantable sensor assembly according to Embodiment 1, wherein the implantable cylinder is mechanically coupled to the component.

[0322] Embodiment 10: The implantable sensor assembly according to Embodiment 8, wherein the implantable cylinder is reversibly coupled to the component.

[0323] Embodiment 11: The implantable sensor assembly according to Embodiment 8, wherein the implantable cylinder forms a one-way positive connection with the component.

[0324] Embodiment 12: The implantable sensor assembly according to Embodiment 8, wherein the implantable cylinder is mechanically coupled to the component using at least one of a corresponding snap ring, lock, twist, thread, or chemical adhesive.

[0325] Embodiment 13: The implantable sensor assembly according to Embodiment 8, wherein the cylinder is press-fitted into the component.

[0326] Embodiment 14: The implantable sensor assembly according to Embodiment 1, wherein the implantable cannula includes a plurality of sensors positioned on the top surface of the implantable cannula.

[0327] Embodiment 15: The implantable sensor assembly according to Embodiment 14, wherein the implantable cannula includes a plurality of sensors positioned on the bottom surface of the implantable cannula.

[0328] Embodiment 16: The implantable sensor assembly according to Embodiment 15, wherein the implantable cannula includes at least one sensor positioned on the proximal surface of the implantable cannula.

[0329] Embodiment 17: The implantable sensor assembly according to Embodiment 16, wherein the implantable cannula includes at least one sensor positioned on the distal surface of the implantable cannula.

[0330] Embodiment 18: The implantable sensor assembly according to Embodiment 16, wherein the plurality of sensors positioned on the top surface of the implantable cannula and the plurality of sensors positioned on the bottom surface of the implantable cannula are configured to measure the sinking of the implantable sensor assembly.

[0331] Embodiment 19: The implantable sensor assembly according to Embodiment 17, wherein at least one sensor positioned on the proximal surface and the distal surface of the implantable cannula provides translational and orientation-related movement of the implantable sensor assembly.

[0332] Embodiment 20: The implantable sensor assembly according to Embodiment 14, wherein the plurality of sensors positioned on the top surface of the implantable cannula are in series.

[0333] Embodiment 21: The implantable sensor assembly according to Embodiment 15, wherein the plurality of sensors positioned on the bottom surface of the implantable cannula are in series.

[0334] Embodiment 22: The implantable sensor assembly according to Embodiment 1, wherein the implantable cannula includes a series of three sensors on the top surface of the implantable cannula, a series of three sensors on the bottom surface of the implantable cannula, a plurality of sensors on the proximal end of the implantable cannula, and a plurality of sensors on the distal end of the implantable cannula.

[0335] Embodiment 23: The implantable sensor assembly according to Embodiment 1, wherein the antenna extends from the proximal or distal end of the implantable cannula.

[0336] Embodiment 24: The implantable sensor assembly according to Embodiment 1, wherein the antenna is contained within a gap of the component.

[0337] Embodiment 25: The implantable sensor assembly according to Embodiment 21, wherein the antenna is contained within the component, and the material composition of the component enables signal transmission from the antenna.

[0338] Embodiment 26: The implantable sensor assembly according to Embodiment 25, wherein the component comprises PEEK.

[0339] Embodiment 27: The implantable sensor assembly according to Embodiment 1 further includes a processor.

[0340] Embodiment 28: The implantable sensor assembly according to Embodiment 1, wherein the component of the implantable prosthesis is an interbody spacer used during spinal fusion.

[0341] Embodiment 29: The implantable sensor assembly according to Embodiment 28, wherein the interbody spacer is a lumbar interbody spacer.

[0342] Embodiment 30: The implantable sensor assembly according to Embodiment 28, wherein the interbody spacer is a cervical interbody spacer.

[0343] Embodiment 31: The implantable sensor assembly according to Embodiment 28, wherein the interbody spacer is a thoracic vertebral interbody spacer.

[0344] Embodiment 32: The implantable sensor assembly according to Embodiment 1, wherein at least one sensor is an ultrasonic sensor.

[0345] Embodiment 33: The implantable sensor assembly according to Embodiment 32, wherein the ultrasonic sensor is an M-mode sensor.

[0346] Embodiment 34: The implantable sensor system according to Embodiment 126, wherein the sensor assembly includes a glucose sensor.

[0347] Embodiment 35: The implantable sensor assembly according to Embodiment 32, wherein the ultrasonic sensor is a low-power sensor.

[0348] Embodiment 36: The implantable sensor assembly according to Embodiment 1, wherein the antenna is a loop antenna.

[0349] Embodiment 37: The implantable sensor assembly according to Embodiment 1, wherein the antenna is a conformal antenna.

[0350] Embodiment 38: The implantable sensor system of Embodiment 1, wherein the antenna continuously transmits sensor data.

[0351] Embodiment 39: The implantable sensor system of Embodiment 1, wherein the antenna intermittently transmits sensor data.

[0352] Embodiment 40: The implantable sensor system according to any one of Embodiments 1 to 3, wherein the sensor continuously detects one or more physiological parameters.

[0353] Embodiment 41: The implantable sensor system according to any one of Embodiments 1 to 3, wherein the sensor intermittently detects one or more physiological parameters.

[0354] Embodiment 42: The implantable sensor system according to any one of Embodiments 32 to 54, further comprising a power source for supplying power to the sensor.

[0355] Embodiment 43: The implantable sensor system of Embodiment 55, wherein the power source is rechargeable.

[0356] Embodiment 44: The implantable sensor system according to any one of Embodiments 32 to 54, wherein the sensor can be powered by a power source external to the patient.

[0357] Embodiment 45: The implantable sensor system according to any one of Embodiments 32 to 59, further comprising a memory device for storing sensor data.

[0358] Embodiment 46: The implantable sensor assembly according to Embodiment 1, further comprising a memory device having sufficient storage to enable firmware upgrade of the implantable sensor assembly.

[0359] Embodiment 47: A spinal implant assembly for use during spinal fusion, the spinal implant assembly comprising:

[0360] An interbody spacer; and

[0361] A cylinder mechanically coupled to the interbody spacer, the cylinder comprising:

[0362] A sensor that is capable of detecting one or more physiological parameters of a patient and generating sensor data;

[0363] An antenna that is in electrical communication with the sensor, wherein the antenna provides two-way data communication to a receiver at a remote location, and

[0364] wherein the cylinder is insertable into a mating concave cavity within the interbody spacer.

[0365] Embodiment 48: The spinal implant assembly according to embodiment 47, wherein the interbody spacer further includes a battery.

[0366] Embodiment 49: The spinal implant assembly according to embodiment 47, wherein the interbody spacer further includes an inertial measurement unit having a plurality of accelerometers and a plurality of gyroscopes.

[0367] Embodiment 50: The spinal implant assembly according to embodiment 49, wherein the inertial measurement unit includes:

[0368] A first accelerometer and a first gyroscope for measuring data associated with a first measurement axis,

[0369] A second accelerometer and a second gyroscope for measuring data associated with a second measurement axis, and

[0370] A third accelerometer and a third gyroscope for measuring data associated with a third measurement axis.

[0371] Embodiment 51: The spinal implant assembly according to embodiment 47, wherein the cylinder has a length that combines a circular, oval, square, or rectangular cross-section.

[0372] Embodiment 52: The spinal implant assembly according to embodiment 47, wherein the cylinder cross-section has a corner radius associated with a square or rectangular cross-section.

[0373] Embodiment 53: The spinal implant assembly according to embodiment 47, wherein the cylinder is mechanically coupled to the interbody spacer.

[0374] Embodiment 54: The spinal implant assembly according to embodiment 47, wherein the cylinder is reversibly coupled to the interbody spacer.

[0375] Embodiment 55: The spinal implant assembly according to embodiment 47, wherein the cylinder forms a one-way positive connection with the interbody spacer.

[0376] Embodiment 56: The spinal implant assembly according to embodiment 47, wherein the barrel is mechanically coupled to the interbody spacer using at least one of a corresponding snap ring, lock, twist, thread, or chemical adhesive.

[0377] Embodiment 57: The spinal implant assembly according to embodiment 47, wherein the barrel is press fit into the interbody spacer.

[0378] Embodiment 58: The spinal implant assembly according to embodiment 47, wherein the barrel includes a plurality of sensors positioned on a top surface of the barrel.

[0379] Embodiment 59 The spinal implant assembly according to embodiment 58, wherein the barrel includes a plurality of sensors positioned on a bottom surface of the barrel.

[0380] Embodiment 60: The spinal implant assembly according to embodiment 59, wherein the barrel includes at least one sensor positioned on a proximal surface of the barrel.

[0381] Example 61: The spinal implant assembly according to embodiment 60, wherein the barrel includes at least one sensor positioned on a distal surface of the barrel.

[0382] Embodiment 62: The spinal implant assembly according to embodiment 59, wherein the plurality of sensors positioned on the top surface of the barrel and the plurality of sensors positioned on the bottom surface of the barrel are configured to measure subsidence of the interbody spacer.

[0383] Embodiment 63: The spinal implant assembly according to embodiment 61, wherein at least one sensor positioned on the proximal surface and the distal surface of the barrel provides translational and orientation related movement of the interbody spacer.

[0384] Embodiment 64: The spinal implant assembly according to embodiment 58, wherein the plurality of sensors positioned on the top surface of the barrel are in series.

[0385] Embodiment 65: The spinal implant assembly according to embodiment 59, wherein the plurality of sensors positioned on the bottom surface of the barrel are in series.

[0386] Example 66The spinal implant assembly according to embodiment 47, wherein the cannula includes a series of three sensors on the top surface of the cannula, a series of three sensors on the bottom surface of the cannula, a plurality of sensors on the proximal end of the cannula, and a plurality of sensors on the distal end of the cannula.

[0387] Example 67 The spinal implant assembly according to embodiment 47, wherein the antenna extends from the proximal end or the distal end of the cannula.

[0388] Example 68 The spinal implant assembly according to embodiment 47, further comprising a processor.

[0389] Example 69 The spinal implant assembly according to embodiment 47, wherein the interbody spacer is inserted into a portion of the lumbar spine of a patient.

[0390] Example 70 The spinal implant assembly according to embodiment 47, wherein the interbody spacer is inserted into a portion of the cervical spine of a patient.

[0391] Example 71 The spinal implant assembly according to embodiment 47, wherein the interbody spacer is inserted into a portion of the thoracic spine of a patient.

[0392] Example 72 The spinal implant assembly according to embodiment 47, wherein at least one sensor is an ultrasonic sensor.

[0393] Example 73 The spinal implant assembly according to embodiment 72, wherein the ultrasonic sensor is an M-mode sensor.

[0394] Example 74 The spinal implant assembly according to embodiment 72, wherein the ultrasonic sensor is a B-mode sensor.

[0395] Example 75 The spinal implant assembly according to embodiment 72, wherein the ultrasonic sensor is a low-power sensor.

[0396] Example 76 The spinal implant assembly according to embodiment 47, wherein the antenna is a loop antenna.

[0397] Example 77 The spinal implant assembly according to embodiment 47, wherein the antenna is a conformal antenna.

[0398] Example 78 The implantable sensor system of embodiment 1, wherein the antenna continuously transmits sensor data.

[0399] Example 79 The implantable sensor system of Example 1, wherein the antenna intermittently transmits sensor data.

[0400] Example 80 The implantable sensor system according to any one of Examples 1 to 3, wherein the sensor continuously detects one or more physiological parameters.

[0401] Example 81 The implantable sensor system according to any one of Examples 1 to 3, wherein the sensor intermittently detects one or more physiological parameters.

[0402] Example 82 The implantable sensor system according to any one of Examples 32 to 54, further comprising a power source for supplying power to the sensor.

[0403] Example 83 The implantable sensor system of Example 55, wherein the power source is rechargeable.

[0404] Example 84 The implantable sensor system according to any one of Examples 32 to 54, wherein the sensor is capable of being powered by a power source external to the patient.

[0405] Example 85 The implantable sensor system according to any one of Examples 32 to 59, further comprising a memory device for storing sensor data.

[0406] Example 86 A method of sampling data from an implantable cartridge coupled to an interbody spacer implanted in a patient, the method comprising:

[0407] Detecting one or more kinematic measurements associated with movement of the patient and generating sensor data; and

[0408] Transmitting the sensor data to a receiver at a remote location and receiving data from the receiver.

[0409] Example 87 The method according to Example 86, wherein detecting one or more kinematic measurements occurs during movement of the patient.

[0410] Example 88 The method according to Example 86, wherein detecting one or more kinematic measurements occurs while the interbody spacer is under load.

[0411] Example 89 The method according to Example 86, wherein the method further comprises calibrating the implantable cartridge when the patient is in a known position.

[0412] Example 90 The method according to embodiment 89, wherein the known position is when the patient is lying down.

[0413] Example 91 The method according to embodiment 89, wherein the known position is when the patient is standing against a wall.

[0414] Example 92 The method according to embodiment 89, wherein the known position is when the patient's back is at a predetermined angle while the patient is in a sitting position.

[0415] Example 93 The method according to embodiment 92, wherein the predetermined angle is 30 degrees, 45 degrees or 90 degrees.

[0416] Example 94 The method according to embodiment 87, wherein the one or more kinematic measurements are used to determine the fusion of the interbody spacer.

[0417] Example 95 The method according to embodiment 87, wherein the one or more kinematic measurements are used to determine the subsidence of the interbody spacer.

[0418] Example 96 The method according to embodiment 95, wherein the subsidence measurement is the amount of force exerted by the vertebra adjacent to the interbody spacer.

[0419] Example 97 The method according to embodiment 87, wherein the one or more kinematic measurements are used to determine the migration of the interbody spacer.

[0420] Example 98 The method according to embodiment 97, wherein the migration measures the translation of the interbody spacer at the implant site.

[0421] Example 99 The method according to embodiment 86, wherein the migration measures the change in the kinematics of the interbody spacer at the implant site.

[0422] Example 100 The method according to embodiment 86, wherein the one or more kinematic measurements are used to determine patient movement.

[0423] Example 101 The method according to embodiment 98, wherein the determined patient movement is at least one of step count, cadence, walking speed, movement angle, and gait.

[0424] Example 102 The method of embodiment 86 further comprises determining how quickly the patient can resume regular activities.

[0425] Example 103 The method according to embodiment 86, wherein the implantable cartridge comprises:

[0426] at least one sensor capable of detecting one or more kinematic measurements associated with a patient and generating sensor data, and

[0427] an antenna in electrical communication with the at least one sensor, wherein the antenna transmits the sensor data to a receiver at a remote location and receives data from the receiver.

[0428] Example 104 The method according to embodiment 101, wherein the implantable cartridge further comprises a battery.

[0429] Example 105 The method according to embodiment 86, wherein detecting one or more kinematic measurements comprises obtaining the one or more kinematic measurements from an inertial measurement unit having a plurality of accelerometers and / or a plurality of gyroscopes.

[0430] Example 106 The system according to embodiment 89, further comprising:

[0431] measuring data associated with a first measurement axis, wherein the data associated with the first measurement axis is obtained from a first accelerometer and a first gyroscope of the inertial measurement unit;

[0432] measuring data associated with a second measurement axis, wherein the data associated with the second measurement axis is obtained from a second accelerometer and a second gyroscope of the inertial measurement unit; and

[0433] measuring data associated with a third measurement axis, wherein the data associated with the third measurement axis is obtained from a third accelerometer and a third gyroscope of the inertial measurement unit.

[0434] Example 107 A spinal implant assembly for use during spinal fusion, the spinal implant assembly comprising:

[0435] a spinal implant, the spinal implant comprising:

[0436] a body,

[0437] an opening at a first end of the body,

[0438] a cavity extending through the body of the spinal implant from the opening toward a second end side of the body, and

[0439] A cylinder, the cylinder being configured to be inserted into the cavity, wherein the cylinder includes an outer wall configured to accommodate a plurality of components.

[0440] Example 108 The spinal implant assembly according to Embodiment 107 further includes a locking structure for fixing the spinal implant to the cylinder.

[0441] Example 109 The spinal implant assembly according to Embodiment 107, wherein at least one of the top surface or the bottom surface of the body includes a plurality of ridges, the plurality of ridges being configured to improve the engagement of the spinal implant with adjacent ridges.

[0442] Example 110 The spinal implant assembly according to Embodiment 107 further includes a hole extending from the top surface of the body to the bottom surface of the body, the hole of the spinal implant being configured to be filled with a biological or synthetic material to assist spinal fusion.

[0443] Example 111 The spinal implant assembly according to Embodiment 107, wherein the cylinder includes a power source.

[0444] Example 112 The spinal implant assembly according to Embodiment 111, wherein the power source is a disposable battery or a rechargeable battery.

[0445] Example 113 The spinal implant assembly according to Embodiment 107, wherein the cylinder includes an antenna.

[0446] Example 114 The spinal implant assembly according to Embodiment 113, wherein the antenna is positioned on the cartridge within the opening of the spinal implant.

[0447] Example 115 The spinal implant assembly according to Embodiment 113, wherein the antenna is positioned within the outer wall of the cylinder.

[0448] Example 116 The spinal implant assembly according to Embodiment 113, wherein the antenna is at least one of a loop antenna and a conformal antenna.

[0449] Example 117 The implantable sensor system of Embodiment 1, wherein the antenna continuously transmits sensor data.

[0450] Example 118 The implantable sensor system of Embodiment 1, wherein the antenna intermittently transmits sensor data.

[0451] Example 119The spinal implant assembly according to Embodiment 107, wherein the cylinder includes a processor.

[0452] Example 120 The spinal implant assembly according to Embodiment 107, wherein the cylinder includes at least one sensor.

[0453] Example 121 The spinal implant assembly according to Embodiment 120, wherein the at least one sensor is an ultrasonic sensor.

[0454] Example 122 The spinal implant assembly according to Embodiment 121, wherein the ultrasonic sensor is a low-power sensor.

[0455] Example 123 The implantable sensor system according to any one of Embodiments 1 to 3, wherein the sensor intermittently detects one or more physiological parameters.

[0456] Example 124 The implantable sensor system according to any one of Embodiments 126 to 141, wherein the sensor assembly includes a memory device for storing the sensor data.

[0457] Example 125 The spinal implant assembly according to Embodiment 107, wherein the cylinder has a certain length and a circular, oval, square, or rectangular cross-section.

[0458] Example 126 The spinal implant assembly according to Embodiment 107, wherein the outer wall has a wall thickness of about 0.5 mm.

[0459] Example 127 The spinal implant assembly according to Embodiment 107, wherein the outer wall has a wall thickness of less than 1 mm.

[0460] Example 128 The spinal implant assembly according to Embodiment 107, wherein the cylinder has an aspect ratio of 1:2.

[0461] Example 129 The spinal implant assembly according to Embodiment 107, wherein the cylinder has an aspect ratio of 2:3.

[0462] Example 130 The spinal implant assembly according to Embodiment 107, wherein the cylinder has a width of 8 mm, a thickness of 4 mm, and a length of 28 mm.

[0463] Example 131 The spinal implant assembly according to Embodiment 107, wherein the cylinder is reversibly coupled to the spinal implant.

[0464] Example 132 The spinal implant assembly according to embodiment 108, wherein the locking structure includes locking spring fingers configured to deform outwardly on the spinal implant upon insertion of the barrel and configured to move back to a proper position once the barrel is fully inserted.

[0465] Example 133 The spinal implant assembly according to embodiment 108, wherein the locking structure includes a pin positioned on the spinal implant and a locking ledge positioned on the barrel, wherein the pin on the spinal implant is configured to hold the locking ledge to hold the barrel after insertion.

[0466] Example 134 The spinal implant assembly according to embodiment 133, wherein the locking flange has the radius of the pin.

[0467] Example 135 The spinal implant assembly according to embodiment 108, wherein the locking structure includes a clip or a groove positioned along the length of the barrel, wherein the clip or the groove is configured to hold the barrel within the spinal implant.

[0468] Example 136 The spinal implant assembly according to embodiment 107, wherein the spinal implant is an interbody spacer or a spinal cage.

[0469] Example 137 An intelligent implant assembly for implanting into a patient, the intelligent implant assembly comprising:

[0470] An implant body, the implant body comprising:

[0471] An opening at a first end of the implant body, and

[0472] A cavity extending through the implant body from the opening towards a second side of the implant body;

[0473] A barrel inserted into the intelligent implant, wherein the barrel is held within the cavity of the implant body and within the outer periphery of the implant body, and wherein the barrel includes an outer wall configured to house a plurality of components; and

[0474] A locking structure for fixing the spinal implant to the spinal implant.

[0475] Example 138The intelligent implant assembly according to embodiment 137, wherein at least one of the left surface or the right surface of the body includes a plurality of ridges, and the plurality of ridges are configured to improve the engagement of the spinal implant with adjacent ridges.

[0476] Example 139 The intelligent implant assembly according to embodiment 137, wherein the cannula includes a power source.

[0477] Example 140 The intelligent implant assembly according to embodiment 139, wherein the power source is a disposable battery or a rechargeable battery.

[0478] Example 141 The intelligent implant assembly according to embodiment 137, wherein the cannula includes an antenna.

[0479] Example 142 The intelligent implant assembly according to embodiment 141, wherein the antenna is positioned on the cannula within the opening of the spinal implant.

[0480] Example 143 The intelligent implant assembly according to embodiment 141, wherein the antenna is positioned within the outer wall of the cannula.

[0481] Example 144 The intelligent implant assembly according to embodiment 141, wherein the antenna is at least one of a loop antenna and a conformal antenna.

[0482] Example 145 The implantable sensor system of embodiment 1, wherein the antenna continuously transmits sensor data.

[0483] Example 146 The implantable sensor system of embodiment 1, wherein the antenna intermittently transmits sensor data.

[0484] Example 147 The intelligent implant assembly according to embodiment 137, wherein the cannula includes a processor.

[0485] Example 148 The intelligent implant assembly according to embodiment 137, wherein the cannula includes at least one sensor.

[0486] Example 149 The intelligent implant assembly according to embodiment 148, wherein the at least one sensor is an ultrasonic sensor.

[0487] Example 150 The intelligent implant assembly according to embodiment 149, wherein the ultrasonic sensor is a low-power sensor.

[0488] Example 151 The intelligent implant component according to embodiment 148, wherein the at least one sensor continuously or intermittently detects one or more physiological parameters.

[0489] Example 152 The intelligent implant component according to embodiment 148, wherein the cartridge includes a memory device for storing data from the at least one sensor.

[0490] Example 153 The intelligent implant component according to embodiment 137, wherein the cartridge has a certain length and a circular, oval, square or rectangular cross-section.

[0491] Example 154 The intelligent implant component according to embodiment 137, wherein the outer wall has a wall thickness of about 0.5 mm.

[0492] Example 155 The intelligent implant component according to embodiment 137, wherein the outer wall has a wall thickness of less than 1 mm.

[0493] Example 156 The intelligent implant component according to embodiment 137, wherein the cartridge has an aspect ratio of 1:2.

[0494] Example 157 The intelligent implant component according to embodiment 137, wherein the cartridge has an aspect ratio of 2:3.

[0495] Example 158 The intelligent implant component according to embodiment 137, wherein the cartridge is reversibly coupled to the spinal implant.

[0496] Example 159 The intelligent implant component according to embodiment 137, wherein the locking structure includes locking spring fingers configured to deform outwardly on the spinal implant when the cartridge is inserted and configured to move back to a proper position once the cartridge is fully inserted.

[0497] Example 160 The intelligent implant component according to embodiment 137, wherein the locking structure includes a pin positioned on the spinal implant and a locking ledge positioned on the cartridge, wherein the pin on the spinal implant is configured to hold the locking ledge to hold the cartridge after insertion.

[0498] Example 161 The intelligent implant component according to embodiment 160, wherein the locking flange has the radius of the pin.

[0499] Example 162The intelligent implant assembly according to Embodiment 137, wherein the locking structure includes a clip or a groove positioned along the length of the barrel, and the clip or the groove is configured to hold the barrel within the spinal implant.

[0500] Example 163 A method for monitoring the recovery of a patient after spinal fusion, the method comprising:

[0501] Providing a spinal implant assembly including a spinal implant and a barrel, the barrel including at least one sensor;

[0502] Collecting, by the at least one sensor, data indicating at least one of fusion, resorption, or migration of the spinal implant; and

[0503] Transmitting the data to a remote location.

[0504] Example 164 The method according to Embodiment 163, wherein the data includes kinematic measurements of the movement of the patient.

[0505] Example 165 The method according to any one of Embodiments 163, wherein the data indicates movement of the spinal implant.

[0506] Example 166 The method according to any one of Embodiments 163, wherein the spinal implant includes an opening and a cavity at a first end of the spinal implant, and the cavity extends from the first end of the spinal implant through the body to a second end of the spinal implant.

[0507] Example 167 The method according to Embodiment 166, wherein the barrel is configured to be inserted into the opening of the spinal implant such that the barrel is fixed in the cavity of the spinal implant.

[0508] Example 168 The method according to Embodiment 163, wherein the barrel includes a power source, a memory source, and a processor.

[0509] Example 169 The method according to Embodiment 163, wherein one of the at least one sensors includes an accelerometer and / or a gyroscope.

[0510] Example 170 The method according to Embodiment 169, wherein the accelerometer and / or the gyroscope is configured to measure at least one of step count, cadence, walking speed, movement angle, or gait of the patient.

[0511] Example 171The method according to Embodiment 163, wherein one of the at least one sensors comprises at least one ultrasonic sensor.

[0512] Example 175 The method according to Embodiment 171, wherein the at least one ultrasonic sensor is configured to detect translation of the spinal implant.

[0513] Example 173 The method according to Embodiment 172, wherein the translation of the spinal implant is configured to measure migration of the spinal implant from the patient's implantation site.

[0514] Example 174 The method according to Embodiment 171, wherein the at least one ultrasonic sensor is configured to measure the distance between the surface of the spinal implant and an adjacent vertebra.

[0515] Example 175 The method according to Embodiment 172, wherein a change in the distance between the surface of the spinal implant and the adjacent vertebra is configured to measure subsidence of the spinal implant.

[0516] Example 176 The method according to Embodiment 163, wherein the at least one sensor comprises at least one vibration sensor.

[0517] Example 177 The method according to Embodiment 176, wherein the at least one vibration sensor is configured to detect acoustic emissions associated with the spinal implant for an adjacent vertebra.

[0518] Example 178 The method according to Embodiment 177, wherein the acoustic emissions are configured to measure fusion of the spinal implant relative to the adjacent vertebra.

[0519] Example 179 The method according to Embodiment 163, wherein the at least one sensor is configured to calibrate the cartridge when the patient is in a known position.

[0520] Example 180 The method according to Embodiment 163, wherein the spinal implant is an interbody spacer or a spinal cage.

[0521] Example 181 A method for monitoring a patient's recovery after spinal fusion, the method comprising:

[0522] Receiving data from a spinal implant assembly;

[0523] Processing the data to evaluate migration of the spinal implant, subsidence of the spinal implant, and / or fusion of the spinal implant; and

[0524] Provide an output to a clinician based on the processed data.

[0525] Example 182 The method according to embodiment 181, wherein the data includes kinematic measurements.

[0526] Example 183 The method according to embodiment 181, wherein the patient kinematic measurements are associated with at least one of a patient's step count, cadence, walking speed, movement angle, or gait.

[0527] Example 184 The method according to embodiment 181, wherein the data includes measurements indicative of migration of the spinal implant.

[0528] Example 185 The method according to embodiment 181, further comprising determining migration of the spinal implant based on translation of the spinal implant.

[0529] Example 186 The method according to embodiment 181, wherein the data includes measurements indicative of subsidence of the spinal implant.

[0530] Example 187 The method according to embodiment 181, further comprising determining subsidence of the spinal implant based on a change in distance between a surface of the spinal implant and an adjacent vertebra.

[0531] Example 188 The method according to embodiment 181, wherein the data includes measurements indicative of fusion of the spinal implant to an adjacent vertebra.

Claims

1. An implantable sensor assembly for use during spinal fusion, the implantable sensor assembly comprising: A component of an implantable prosthesis; And An implantable cannula associated with the component, the implantable cannula comprising: At least one sensor capable of detecting one or more kinematic measurements associated with a patient and generating sensor data, and An antenna in electrical communication with the at least one sensor, wherein the antenna transmits the sensor data to a receiver at a remote location.

2. The implantable sensor assembly according to claim 1, wherein the implantable cannula further comprises a battery.

3. The implantable sensor assembly according to any one of claims 1 or 2, wherein the implantable cannula further comprises an inertial measurement unit having a plurality of accelerometers and / or a plurality of gyroscopes.

4. The implantable sensor assembly according to claim 3, wherein the inertial measurement unit comprises: A first accelerometer and / or a first gyroscope for measuring data associated with a first measurement axis, A second accelerometer and / or a second gyroscope for measuring data associated with a second measurement axis, and A third accelerometer and / or a third gyroscope for measuring data associated with a third measurement axis.

5. The implantable sensor assembly according to any one of claims 1 to 4, wherein the implantable cannula has a certain length and a circular, elliptical, square or rectangular cross-section.

6. The implantable sensor assembly according to any one of claims 1 to 5, wherein the implantable cannula has a cross-section having a corner radius associated with a square or rectangular cross-section.

7. The implantable sensor assembly according to any one of claims 1 to 6, wherein the implantable cannula is positioned within the component.

8. The implantable sensor assembly according to any one of claims 1 to 7, wherein the implantable cannula is capable of being inserted into a slot of the component.

9. The implantable sensor assembly according to any one of claims 1 to 8, wherein the implantable cannula is mechanically coupled to the component.

10. The implantable sensor assembly according to claim 8, wherein the implantable cannula is reversibly coupled to the component.

11. The implantable sensor assembly according to claim 8, wherein the implantable cannula forms a one-way positive connection with the component.

12. The implantable sensor assembly according to claim 8, wherein the implantable cannula is mechanically coupled to the component using at least one of a corresponding snap ring, lock, turnbuckle, thread or chemical adhesive.

13. The implantable sensor assembly according to claim 8, wherein the implantable cannula is press-fitted into the component.

14. The implantable sensor assembly according to any one of claims 1 to 13, wherein the implantable cannula comprises a plurality of sensors positioned on a top surface of the implantable cannula.

15. The implantable sensor assembly according to claim 14, wherein the implantable cylinder includes a plurality of sensors positioned on the bottom surface of the implantable cylinder.

16. The implantable sensor assembly according to claim 15, wherein the implantable cylinder includes at least one sensor positioned on the proximal surface of the implantable cylinder.

17. The implantable sensor assembly according to claim 16, wherein the implantable cylinder includes at least one sensor positioned on the distal surface of the implantable cylinder.

18. The implantable sensor assembly according to claim 16, wherein the plurality of sensors positioned on the top surface of the implantable cylinder and the plurality of sensors positioned on the bottom surface of the implantable cylinder are configured to measure the subsidence of the implantable sensor assembly.

19. The implantable sensor assembly according to claim 17, wherein the at least one sensor positioned on the proximal surface and the distal surface of the implantable cylinder provides translational and orientation-related movement of the implantable sensor assembly.

20. The implantable sensor assembly according to any one of claims 14 to 19, wherein the plurality of sensors positioned on the top surface of the implantable cylinder are in series.

21. The implantable sensor assembly according to any one of claims 15 to 19, wherein the plurality of sensors positioned on the bottom surface of the implantable cylinder are in series.

22. The implantable sensor assembly according to any one of claims 1 to 21, wherein the implantable cylinder includes three sensors in series on the top surface of the implantable cylinder, three sensors in series on the bottom surface of the implantable cylinder, a plurality of sensors on the proximal end of the implantable cylinder, and a plurality of sensors on the distal end of the implantable cylinder.

23. The implantable sensor assembly according to any one of claims 1 to 22, wherein the antenna extends from the proximal end or the distal end of the implantable cylinder.

24. The implantable sensor assembly according to any one of claims 1 to 23, wherein the antenna is housed in a gap of the component.

25. The implantable sensor assembly according to claim 21, wherein the antenna is housed in the component, and the material composition of the component enables signal transmission from the antenna.

26. The implantable sensor assembly according to claim 25, wherein the component contains PEEK.

27. The implantable sensor assembly according to any one of claims 1 to 26, further comprising a processor.

28. The implantable sensor assembly according to any one of claims 1 to 27, wherein the component of the implantable prosthesis is an interbody spacer for use during spinal fusion.

29. The implantable sensor assembly according to claim 28, wherein the interbody spacer is a lumbar interbody spacer.

30. The implantable sensor assembly according to claim 28, wherein the interbody spacer is a cervical interbody spacer.

31. The implantable sensor assembly according to claim 28, wherein the interbody spacer is a thoracic interbody spacer.

32. The implantable sensor assembly according to any one of claims 1 to 31, wherein the at least one sensor is an ultrasonic sensor.

33. The implantable sensor assembly according to claim 32, wherein the ultrasonic sensor is an M-mode sensor.

34. The implantable sensor assembly according to claim 32, wherein the ultrasonic sensor is a B-mode sensor.

35. The implantable sensor assembly according to claim 32, wherein the ultrasonic sensor is a low-power sensor.

36. The implantable sensor assembly according to any one of claims 1 to 35, wherein the antenna is a loop antenna.

37. The implantable sensor assembly according to any one of claims 1 to 36, wherein the antenna is a conformal antenna.

38. The implantable sensor assembly according to any one of claims 1 to 37, wherein the antenna continuously transmits sensor data.

39. The implantable sensor assembly according to any one of claims 1 to 38, wherein the antenna intermittently transmits sensor data.

40. The implantable sensor assembly according to any one of claims 1 to 39, wherein the at least one sensor continuously detects one or more physiological parameters.

41. The implantable sensor assembly according to any one of claims 1 to 40, wherein the at least one sensor intermittently detects one or more physiological parameters.

42. The implantable sensor assembly according to any one of claims 1 to 41, further comprising a power source for supplying power to the at least one sensor.

43. The implantable sensor assembly according to claim 42, wherein the power source is rechargeable.

44. The implantable sensor assembly according to any one of claims 1 to 43, wherein the at least one sensor can be powered by a power source outside the patient's body.

45. The implantable sensor assembly according to any one of claims 1 to 44, further comprising a memory device for storing data from the at least one sensor.

46. The implantable sensor assembly according to any one of claims 1 to 45, further comprising a memory device having sufficient storage to enable firmware upgrade of the implantable sensor assembly.

47. A spinal implant assembly for use during spinal fusion, the spinal implant assembly comprising: An interbody spacer; And A cylinder mechanically coupled to the interbody spacer, the cylinder comprising: At least one sensor capable of detecting one or more physiological parameters of a patient and generating sensor data, An antenna in electrical communication with the at least one sensor, wherein the antenna provides two-way data communication to a receiver at a remote location, and Wherein the cylinder can be inserted into a mating cavity within the interbody spacer.

48. The spinal implant assembly according to claim 47, wherein the interbody spacer further comprises a battery.

49. The spinal implant assembly according to any one of claims 47 to 48, wherein the interbody spacer further includes an inertial measurement unit having a plurality of accelerometers and a plurality of gyroscopes.

50. The spinal implant assembly according to claim 49, wherein the inertial measurement unit includes: a first accelerometer and a first gyroscope for measuring data associated with a first measurement axis, a second accelerometer and a second gyroscope for measuring data associated with a second measurement axis, and a third accelerometer and a third gyroscope for measuring data associated with a third measurement axis.

51. The spinal implant assembly according to any one of claims 47 to 50, wherein the barrel has a certain length and a circular, elliptical, square or rectangular cross-section.

52. The spinal implant assembly according to any one of claims 47 to 51, wherein the barrel cross-section has a corner radius associated with a square or rectangular cross-section.

53. The spinal implant assembly according to any one of claims 47 to 52, wherein the barrel is mechanically coupled to the interbody spacer.

54. The spinal implant assembly according to any one of claims 47 to 53, wherein the barrel is reversibly coupled to the interbody spacer.

55. The spinal implant assembly according to any one of claims 47 to 54, wherein the barrel forms a one-way positive connection with the interbody spacer.

56. The spinal implant assembly according to any one of claims 47 to 55, wherein the barrel is mechanically coupled to the interbody spacer using at least one of a corresponding snap ring, lock, turnbuckle, thread or chemical adhesive.

57. The spinal implant assembly according to any one of claims 47 to 56, wherein the barrel is press-fitted into the interbody spacer.

58. The spinal implant assembly according to any one of claims 47 to 57, wherein the barrel includes a plurality of sensors positioned on the top surface of the barrel.

59. The spinal implant assembly according to claim 58, wherein the barrel includes a plurality of sensors positioned on the bottom surface of the barrel.

60. The spinal implant assembly according to claim 59, wherein the barrel includes at least one sensor positioned on the proximal surface of the barrel.

61. The spinal implant assembly according to claim 60, wherein the barrel includes at least one sensor positioned on the distal surface of the barrel.

62. The spinal implant assembly according to any one of claims 59 to 61, wherein the plurality of sensors positioned on the top surface of the barrel and the plurality of sensors positioned on the bottom surface of the barrel are configured to measure the subsidence of the interbody spacer.

63. The spinal implant assembly according to claim 61, wherein the at least one sensor positioned on the proximal surface and the distal surface of the barrel provides translational and orientation-related movement of the interbody spacer.

64. The spinal implant assembly according to any one of claims 58 to 63, wherein the plurality of sensors positioned on the top surface of the cylinder are in series.

65. The spinal implant assembly according to any one of claims 59 to 64, wherein the plurality of sensors positioned on the bottom surface of the cylinder are in series.

66. The spinal implant assembly according to any one of claims 47 to 65, wherein the cylinder includes three sensors in series on the top surface of the cylinder, three sensors in series on the bottom surface of the cylinder, a plurality of sensors on the proximal end of the cylinder, and a plurality of sensors on the distal end of the cylinder.

67. The spinal implant assembly according to any one of claims 47 to 66, wherein the antenna extends from the proximal end or the distal end of the cylinder.

68. The spinal implant assembly according to any one of claims 47 to 67, further comprising a processor.

69. The spinal implant assembly according to any one of claims 47 to 68, wherein the interbody spacer is inserted into a part of the lumbar spine of the patient.

70. The spinal implant assembly according to any one of claims 47 to 69, wherein the spinal cage interbody spacer is inserted into a part of the cervical spine of the patient.

71. The spinal implant assembly according to any one of claims 47 to 70, wherein the interbody spacer is inserted into a part of the thoracic spine of the patient.

72. The spinal implant assembly according to any one of claims 47 to 71, wherein the at least one sensor is an ultrasonic sensor.

73. The spinal implant assembly according to claim 72, wherein the ultrasonic sensor is an M-mode sensor.

74. The spinal implant assembly according to claim 72, wherein the ultrasonic sensor is a B-mode sensor.

75. The spinal implant assembly according to claim 72, wherein the ultrasonic sensor is a low-power sensor.

76. The spinal implant assembly according to any one of claims 47 to 75, wherein the antenna is a loop antenna.

77. The spinal implant assembly according to any one of claims 47 to 76, wherein the antenna is a conformal antenna.

78. The spinal implant assembly according to any one of claims 47 to 77, wherein the antenna continuously transmits sensor data.

79. The spinal implant assembly according to any one of claims 47 to 78, wherein the antenna intermittently transmits sensor data.

80. The spinal implant assembly according to any one of claims 47 to 79, wherein the at least one sensor continuously detects one or more physiological parameters.

81. The spinal implant assembly according to any one of claims 47 to 80, wherein the at least one sensor intermittently detects one or more physiological parameters.

82. The spinal implant assembly according to any one of claims 47 to 81, further comprising a power source for supplying power to the at least one sensor.

83. The spinal implant assembly according to claim 82, wherein the power source is rechargeable.

84. The spinal implant assembly according to any one of claims 47 to 83, wherein the at least one sensor is capable of being powered by a power source external to the patient's body.

85. The spinal implant assembly according to any one of claims 47 to 84, further comprising a memory device for storing data from the at least one sensor.

86. A method of sampling data from an implantable cartridge coupled to an interbody spacer implanted in a patient, the method comprising: detecting one or more kinematic measurements associated with movement of the patient and generating sensor data; and transmitting the sensor data to a receiver at a remote location and receiving data from the receiver.

87. The method according to claim 86, wherein detecting the one or more kinematic measurements is performed during movement of the patient.

88. The method according to any one of claims 86 to 87, wherein detecting the one or more kinematic measurements is performed with the interbody spacer under load.

89. The method according to any one of claims 86 to 88, wherein the method further comprises calibrating the implantable cartridge when the patient is in a known orientation.

90. The method according to claim 89, wherein the known orientation is when the patient is lying down.

91. The method according to any one of claims 89 to 90, wherein the known orientation is when the patient is standing against a wall.

92. The method according to any one of claims 89 to 91, wherein the known orientation is when the patient is in a seated position and the patient's back is at a predetermined angle.

93. The method according to claim 92, wherein the predetermined angle is 30 degrees, 45 degrees, or 90 degrees.

94. The method according to any one of claims 87 to 93, wherein the one or more kinematic measurements are used to determine fusion of the interbody spacer.

95. The method according to any one of claims 87 to 94, wherein the one or more kinematic measurements are used to determine subsidence of the interbody spacer.

96. The method according to claim 95, wherein subsidence measures the force exerted on vertebrae adjacent to the interbody spacer.

97. The method according to any one of claims 87 to 96, wherein the one or more kinematic measurements are used to determine migration of the interbody spacer.

98. The method according to claim 97, wherein migration measures translation of the interbody spacer at the implantation site.

99. The method according to any one of claims 86 to 98, wherein migration measures a change in kinematics of the interbody spacer at the implantation site.

100. The method according to any one of claims 86 to 99, wherein the one or more kinematic measurements are used to determine patient movement.

101. The method according to claim 98, wherein the determined patient movement is at least one of step count, cadence, walking speed, movement angle, and gait.

102. The method according to any one of claims 86 to 101, further comprising determining how quickly the patient can resume regular activities.

103. The method according to any one of claims 86 to 102, wherein the implantable cartridge comprises: at least one sensor capable of detecting one or more kinematic measurements associated with the patient and generating sensor data, and an antenna in electrical communication with the at least one sensor, wherein the antenna transmits the sensor data to a receiver at a remote location and receives data from the receiver.

104. The method according to claim 101, wherein the implantable cartridge further comprises a battery.

105. The method according to any one of claims 86 to 104, wherein detecting one or more kinematic measurements comprises obtaining the one or more kinematic measurements from an inertial measurement unit having a plurality of accelerometers and / or a plurality of gyroscopes.

106. The method according to claim 105, further comprising: measuring data associated with a first measurement axis, wherein the data associated with the first measurement axis is obtained from a first accelerometer and a first gyroscope of the inertial measurement unit; measuring data associated with a second measurement axis, wherein the data associated with the second measurement axis is obtained from a second accelerometer and a second gyroscope of the inertial measurement unit; and measuring data associated with a third measurement axis, wherein the data associated with the third measurement axis is obtained from a third accelerometer and a third gyroscope of the inertial measurement unit.

107. A spinal implant assembly for use during spinal fusion, the spinal implant assembly comprising: a spinal implant, the spinal implant comprising: a body, an opening located on a first end of the body, a cavity extending through the body of the spinal implant from the opening towards a second end side of the body, and a cartridge configured to be inserted into the cavity, wherein the cartridge comprises an outer wall configured to accommodate a plurality of components.

108. The spinal implant assembly according to claim 107, further comprising a locking structure for fastening the spinal implant to the cartridge.

109. The spinal implant assembly according to any one of claims 107 to 108, wherein at least one of a top surface or a bottom surface of the body comprises a plurality of ridges, wherein the plurality of ridges are configured to improve the engagement of the spinal implant with adjacent vertebrae.

110. The spinal implant assembly according to any one of claims 107 to 109, further comprising a hole extending from a top surface of the body to a bottom surface of the body, the hole of the spinal implant being configured to be filled with a biological or synthetic material to assist spinal fusion.

111. The spinal implant assembly according to any one of claims 107 to 110, wherein the cartridge comprises a power source.

112. The spinal implant assembly according to claim 111, wherein the power source is a disposable battery or a rechargeable battery.

113. The spinal implant assembly according to any one of claims 107 to 112, wherein the cannula includes an antenna.

114. The spinal implant assembly according to claim 113, wherein the antenna is positioned on the cannula within the opening of the spinal implant.

115. The spinal implant assembly according to claim 113, wherein the antenna is positioned within the outer wall of the cannula.

116. The spinal implant assembly according to claim 113, wherein the antenna is at least one of a loop antenna and a conformal antenna.

117. The spinal implant assembly according to claim 113, wherein the antenna continuously transmits sensor data.

118. The spinal implant assembly according to claim 113, wherein the antenna intermittently transmits sensor data.

119. The spinal implant assembly according to any one of claims 107 to 118, wherein the cannula includes a processor.

120. The spinal implant assembly according to any one of claims 107 to 119, wherein the cannula includes at least one sensor.

121. The spinal implant assembly according to claim 120, wherein the at least one sensor is an ultrasonic sensor.

122. The spinal implant assembly according to claim 121, wherein the ultrasonic sensor is a low-power sensor.

123. The spinal implant assembly according to any one of claims 120 to 122, wherein the at least one sensor continuously or intermittently detects one or more physiological parameters.

124. The spinal implant assembly according to any one of claims 120 to 123, wherein the cannula includes a memory device for storing data from the at least one sensor.

125. The spinal implant assembly according to any one of claims 107 to 124, wherein the cannula has a certain length and a circular, oval, square, or rectangular cross-section.

126. The spinal implant assembly according to any one of claims 107 to 125, wherein the outer wall has a wall thickness of about 0.5 mm.

127. The spinal implant assembly according to any one of claims 107 to 126, wherein the outer wall has a wall thickness of less than 1 mm.

128. The spinal implant assembly according to any one of claims 107 to 127, wherein the cannula has an aspect ratio of 1:

2.

129. The spinal implant assembly according to any one of claims 107 to 128, wherein the cannula has an aspect ratio of 2:

3.

130. The spinal implant assembly according to any one of claims 107 to 129, wherein the cannula has a width of 8 mm, a thickness of 4 mm, and a length of 28 mm.

131. The spinal implant assembly according to any one of claims 107 to 130, wherein the cannula is reversibly coupled to the spinal implant.

132. The spinal implant assembly according to any one of claims 108 to 131, wherein the locking structure includes locking spring fingers configured to deform outwardly on the spinal implant upon insertion of the barrel and configured to move back to a proper position once the barrel is fully inserted.

133. The spinal implant assembly according to any one of claims 108 to 132, wherein the locking structure includes a pin positioned on the spinal implant and a locking flange positioned on the barrel, wherein the pin on the spinal implant is configured to hold the locking flange to retain the barrel after insertion.

134. The spinal implant assembly according to claim 133, wherein the locking flange has a radius of the pin.

135. The spinal implant assembly according to any one of claims 108 to 134, wherein the locking structure includes a clamp or a groove positioned along the length of the barrel, wherein the clamp or the groove is configured to hold the barrel within the spinal implant.

136. The spinal implant assembly according to any one of claims 107 to 135, wherein the spinal implant is an interbody spacer or a spinal cage.

137. An intelligent implant assembly for implantation into a patient, the intelligent implant assembly comprising: an implant body, the implant body including: an opening located at a first end of the implant body, and a cavity extending through the implant body from the opening toward a second side of the implant body; a barrel inserted into the intelligent implant, wherein the barrel is held within the cavity of the implant body and within the outer periphery of the implant body, and wherein the barrel includes an outer wall configured to house a plurality of components; and a locking structure for fastening the spinal implant to the spinal implant.

138. The intelligent implant assembly according to claim 1, wherein at least one of a left surface or a right surface of the body includes a plurality of ridges configured to improve the engagement of the spinal implant with adjacent vertebrae.

139. The intelligent implant assembly according to any one of claims 137 to 138, wherein the barrel includes a power source.

140. The intelligent implant assembly according to claim 139, wherein the power source is a disposable battery or a rechargeable battery.

141. The intelligent implant assembly according to any one of claims 137 to 140, wherein the barrel includes an antenna.

142. The intelligent implant assembly according to claim 141, wherein the antenna is positioned on the barrel within the opening of the spinal implant.

143. The intelligent implant assembly according to claim 141, wherein the antenna is positioned within the outer wall of the barrel.

144. The intelligent implant assembly according to claim 141, wherein the antenna is at least one of a loop antenna and a conformal antenna.

145. The intelligent implant assembly according to claim 141, wherein the antenna continuously transmits sensor data.

146. The intelligent implant component as claimed in claim 141, wherein the antenna intermittently transmits sensor data.

147. The intelligent implant component as claimed in any one of claims 137 to 146, wherein the barrel comprises a processor.

148. The intelligent implant component as claimed in any one of claims 137 to 147, wherein the barrel comprises at least one sensor.

149. The intelligent implant component as claimed in claim 148, wherein the at least one sensor is an ultrasonic sensor.

150. The intelligent implant component as claimed in claim 149, wherein the ultrasonic sensor is a low-power sensor.

151. The intelligent implant component as claimed in claim 148, wherein the at least one sensor continuously or intermittently detects one or more physiological parameters.

152. The intelligent implant component as claimed in claim 148, wherein the barrel comprises a memory device for storing data from the at least one sensor.

153. The intelligent implant component as claimed in any one of claims 137 to 152, wherein the barrel has a certain length and a circular, elliptical, square or rectangular cross-section.

154. The intelligent implant component as claimed in any one of claims 137 to 153, wherein the outer wall has a wall thickness of about 0.5 mm.

155. The intelligent implant component as claimed in any one of claims 137 to 154, wherein the outer wall has a wall thickness of less than 1 mm.

156. The intelligent implant component as claimed in any one of claims 137 to 155, wherein the barrel has an aspect ratio of 1:

2.

157. The intelligent implant component as claimed in any one of claims 137 to 156, wherein the barrel has an aspect ratio of 2:

3.

158. The intelligent implant component as claimed in any one of claims 137 to 157, wherein the barrel is reversibly coupled to the spinal implant.

159. The intelligent implant component as claimed in any one of claims 137 to 158, wherein the locking structure comprises locking spring fingers configured to deform outwardly on the spinal implant upon insertion of the barrel and configured to move back to a proper position once the barrel is fully inserted.

160. The intelligent implant component as claimed in any one of claims 137 to 159, wherein the locking structure comprises a pin positioned on the spinal implant and a locking flange positioned on the barrel, wherein the pin on the spinal implant is configured to hold the locking flange to hold the barrel after insertion.

161. The intelligent implant component as claimed in claim 160, wherein the locking flange has the radius of the pin.

162. The intelligent implant component as claimed in any one of claims 137 to 161, wherein the locking structure comprises a clamp or a groove positioned along the length of the barrel, wherein the clamp or the groove is configured to hold the barrel within the spinal implant.

163. A method of monitoring a patient's recovery after spinal fusion, the method comprising: Provided is a spinal implant assembly including a spinal implant and a cannula, the cannula including at least one sensor; Collecting, by the at least one sensor, data indicative of at least one of fusion, subsidence, or migration of the spinal implant; And Transmitting the data to a remote location.

164. The method according to claim 163, wherein the data includes kinematic measurements of the patient's movement.

165. The method according to any one of claims 163 to 164, wherein the data indicates movement of the spinal implant.

166. The method according to any one of claims 163 to 165, wherein the spinal implant includes a cavity and an opening at a first end of the spinal implant, and the cavity extends from the first end of the spinal implant through the body to a second end of the spinal implant.

167. The method according to claim 166, wherein the cannula is configured to be inserted into the opening of the spinal implant such that the cannula is fastened in the cavity of the spinal implant.

168. The method according to any one of claims 163 to 167, wherein the cannula includes a power source, a memory source, and a processor.

169. The method according to any one of claims 163 to 168, wherein one of the at least one sensors includes an accelerometer and / or a gyroscope.

170. The method according to claim 169, wherein the accelerometer and / or the gyroscope is configured to measure at least one of a patient's step count, cadence, walking speed, movement angle, or gait.

171. The method according to any one of claims 163 to 170, wherein one of the at least one sensors includes at least one ultrasonic sensor.

172. The method according to claim 171, wherein the at least one ultrasonic sensor is configured to detect translation of the spinal implant.

173. The method according to claim 172, wherein the translation of the spinal implant is configured to measure migration of the spinal implant from the patient's implantation site.

174. The method according to any one of claims 171 to 173, wherein the at least one ultrasonic sensor is configured to measure a distance between a surface of the spinal implant and an adjacent vertebra.

175. The method according to any one of claims 172 to 174, wherein a change in the distance between the surface of the spinal implant and the adjacent vertebra is configured to measure subsidence of the spinal implant.

176. The method according to any one of claims 163 to 175, wherein the at least one sensor includes at least one vibration sensor.

177. The method according to claim 176, wherein the at least one vibration sensor is configured to detect acoustic emissions associated with the spinal implant for an adjacent vertebra.

178. The method according to claim 177, wherein the acoustic emissions are configured to measure fusion of the spinal implant to the adjacent vertebra.

179. The method according to any one of claims 163 to 178, wherein the at least one sensor is configured to calibrate the cartridge when the patient is in a known position.

180. The method according to any one of claims 163 to 179, wherein the spinal implant is an interbody spacer or a spinal cage.

181. A method for monitoring the recovery of a patient after spinal fusion, the method comprising: Receiving data from a spinal implant assembly; Processing the data to evaluate migration of the spinal implant, subsidence of the spinal implant, and / or fusion of the spinal implant; And Providing an output to a clinician based on the processed data.

182. The method according to claim 181, wherein the data includes kinematic measurements.

183. The method according to any one of claims 181 to 182, wherein the patient kinematic measurements are associated with at least one of a patient's step count, cadence, walking speed, movement angle, or gait.

184. The method according to any one of claims 181 to 183, wherein the data includes measurements indicative of migration of the spinal implant.

185. The method according to any one of claims 181 to 184, further comprising determining migration of the spinal implant based on translation of the spinal implant.

186. The method according to any one of claims 181 to 185, wherein the data includes measurements indicative of subsidence of the spinal implant.

187. The method according to any one of claims 181 to 186, further comprising determining subsidence of the spinal implant based on a change in distance between a surface of the spinal implant and an adjacent vertebra.

188. The method according to any one of claims 181 to 187, wherein the data includes measurements indicative of fusion of the spinal implant to an adjacent vertebra.

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