Spinal implantable sensor assembly

Abstract

An implantable sensor assembly for use during spinal fusion may include an implantable prosthesis component 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, the antenna transmitting the sensor data to a receiver at a remote location.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS All applications filed with this application for which a foreign or domestic priority claim is identified in the Application Data Sheet are hereby incorporated by reference. [Background technology]

[0002] The present disclosure relates generally to intelligent implants relating to implantable systems such as spinal implants, and more particularly to intelligent implants with an implantable reporting processor that samples, records, and transmits information regarding the placement and integrity of the implanted system, the health of the patient in whom the system is implanted, as well as characteristics of the intelligent implant, including enhanced transmit antenna configurations and data sampling methods.

[0003] 2. Description of Related Art Spinal implants can be configured to connect two or more vertebrae of the spine. Spinal fusion can occur in any part of the spine (e.g., lumbar, cervical, thoracic). Systems intended to permanently connect two or more vertebrae to eliminate movement between them are called spinal fusions, which include techniques designed to form bridging bone between the vertebrae as part of the healing process.

[0004] Currently, there is no mechanism for reliably detecting spinal implant misplacement, instability, or malalignment without a clinical visit and the manual and visual observation of an experienced medical professional. Even so, early identification of subclinical problems or conditions is either difficult or impossible because they are often too subtle to be detected by physical examination or demonstrable by radiographic studies. Furthermore, even when detection is possible, corrective action is hindered by the fact that the specific amount of movement and / or degree of improper alignment cannot be accurately measured or quantified, reducing the likelihood of targeted and successful intervention. Existing external monitoring devices do not provide the fidelity necessary to detect instability because they are separated from the spinal implant by skin, muscle, and fat. Each of these masks the mechanical signature of instability and introduces anomalies such as flexion, tissue-borne acoustic noise, inconsistent sensor placement on the surface, and inconsistent location of the external sensor relative to the spinal implant.

[0005] Furthermore, patients may experience several complications after the procedure, including neurological symptoms, pain, dysfunction (blockage, loosening, etc.), and / or implant wear, implant migration or breakage, inflammation, and / or infection. While some of these problems can be addressed with medications and / or further surgery, they are difficult to predict and prevent, and in many cases, early identification of complications and side effects, while desirable, is difficult or impossible.

[0006] The present disclosure is directed to an intelligent implant with an implantable reporting processor that samples, records, and transmits information related to the placement and integrity of the spinal implant and the health of the patient in whom the spinal implant is implanted, as well as an intelligent implant with an enhanced transmit antenna configuration and data sampling method. Summary of the Invention

[0007] In some aspects, an implantable sensor assembly for use during spinal fusion or other spinal procedures is disclosed. The implantable sensor assembly can include a component and an implantable cartridge associated with the component. The component can form a portion of an implantable prosthesis. The implantable cartridge can include at least one sensor capable of detecting one or more kinematic measurements associated with the patient and generating sensor data. The implantable cartridge can also include an antenna in electrical communication with the sensor. The antenna can transmit the sensor data to a receiver at a remote location.

[0008] The implantable sensor assembly may include one or more of the following features: The implantable cartridge may include a battery. The implantable cartridge may include an inertial measurement unit having multiple accelerometers and / or multiple gyroscopes. For example, the inertial measurement unit may include a first accelerometer and / or a first gyroscope for measuring data related to a first measurement axis. The inertial measurement unit may also include a second accelerometer and / or a second gyroscope for measuring data related to a second measurement axis. The inertial measurement unit may also include a third accelerometer and / or a third gyroscope for measuring data related to a third measurement axis. In some configurations, the implantable cartridge may have two or more separate inertial measurement units for use in separate evaluations, e.g., separate motor functions. In some configurations, the implantable cartridge may have one or more accelerometers and / or gyroscopes separate from the inertial measurement unit.

[0009] In certain aspects, the implantable cartridge may include a length in conjunction with a circular, oval, square, or rectangular cross-section. The implantable cartridge may have a cross-section with a corner radius associated with the 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 insertable into an opening in an interbody spacer or into a slot in a cage. The cartridge may be mechanically coupled to the component. The cartridge may be reversibly coupled to the 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, torsion, or chemical adhesive. The cartridge may be press-fit within the component. The cartridge may include multiple sensors positioned on a top surface of the cartridge. The cartridge may include multiple sensors positioned on a bottom surface of the cartridge. The cartridge may include at least one sensor positioned on a proximal surface of the cartridge. The cartridge may include at least one sensor positioned on the distal surface of the cartridge. Multiple sensors may be positioned on the top surface of the cartridge, and multiple sensors positioned on the bottom surface of the cartridge measure 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 movement related to the translation and orientation of the implantable sensor assembly. Multiple sensors may be positioned on the top surface of the cartridge in series. Multiple 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, multiple sensors on the proximal end of the cartridge, and multiple sensors on the distal end of the cartridge. The antenna may extend from the proximal or distal end of the cartridge. The antenna may be contained within a gap in the component.The antenna may be contained within a component whose material composition allows for signal transmission from the antenna. The component may include polyetheretherketone (PEEK). The implantable sensor assembly may further include a processor. The implantable prosthesis component may be an interbody spacer or a cage for use during spinal fusion. The interbody spacer may be inserted in the lumbar region of the spine. The interbody spacer may be inserted in the cervical region of the spine. The interbody spacer may be inserted in 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, which may be an ultrasound sensor. The ultrasound sensor may be an M-mode sensor. The ultrasound sensor may be a B-mode sensor. The ultrasound 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. The at least one sensor may be capable of continuously detecting one or more physiological parameters. The at least one sensor may be capable of intermittently detecting one or more physiological parameters. The power source may provide power to the at least one sensor. Thus, the power source may be rechargeable. The at least one sensor may be powered by a power source outside the patient's body. The implantable sensor may further include a memory device for storing data from the at least one sensor. The memory device may have sufficient memory to allow firmware upgrades of the sensor assembly.

[0010] In some aspects, a spinal implant assembly for use during spinal fusion or other spinal procedures is disclosed. The cartridge can be mechanically coupled to an interbody spacer or spinal cage. The cartridge can include at least one sensor and an antenna. The at least one sensor can detect one or more physiological parameters of the patient and generate sensor data. The antenna can be in electrical communication with the at least one sensor and provide bidirectional data communication to a receiver at a remote location. The cartridge can be insertable into a mating female cavity in the interbody spacer or spinal cage.

[0011] 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 related to a first measurement axis. The inertial measurement unit may include a second accelerometer and a second gyroscope for measuring data related to a second measurement axis. The inertial measurement unit may include a third accelerometer and a third gyroscope for measuring data related to a third measurement axis. The inertial measurement unit may include a tilt sensor. The inertial measurement unit may include a strain sensor or other type of sensor that measures and / or responds to deflection. The inertial measurement unit may include one or more of an accelerometer, a gyroscope, a tilt sensor, and a strain sensor. For example, the inertial measurement unit may include an accelerometer, a gyroscope, and a tilt sensor. The cartridge may have a length with a circular, elliptical, square, or rectangular cross-section. The cartridge may have a cross-section with a corner radius associated with the square or rectangular cross-section. The cartridge may be mechanically coupled to the interbody spacer or spine cage. The cartridge may be reversibly coupled to the interbody spacer or spine cage. The cartridge may form a one-way positive connection with the interbody spacer or spine cage. The cartridge may be mechanically coupled to the interbody spacer or spine cage using at least one of a corresponding snap ring, lock, twist, torsion, or chemical adhesive. The cartridge may be press-fit to the interbody spacer or spine cage. The cartridge may include multiple sensors positioned on a top surface of the cartridge. The cartridge may include multiple sensors positioned on a bottom surface of the cartridge. The cartridge may include at least one sensor positioned on a proximal surface of the cartridge. The cartridge may include at least one sensor positioned on a distal surface of the cartridge.The plurality of sensors positioned on the top surface of the cartridge and the plurality of sensors positioned on the bottom surface of the cartridge can be configured to measure subsidence of the interbody spacer or spinal cage. At least one sensor can be on the proximal surface of the cartridge, and the distal surface of the cartridge provides movement related to the translation and orientation of the interbody spacer or spinal cage. The plurality of sensors positioned on the top surface of the cartridge can be in series. The plurality of sensors positioned on the bottom surface of the cartridge can be in series. The cartridge can 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, multiple sensors on the proximal end of the cartridge, and multiple sensors on the distal end of the cartridge. The antenna can extend from the proximal or distal end of the cartridge. The spinal implant assembly can include a processor. The spinal implant assembly can be inserted into a portion of the patient's lumbar spine. The spinal page can be inserted into a portion of the patient's cervical spine. The interbody spacer or spinal cage can be inserted into a portion of the patient's thoracic spine. At least one sensor can be an ultrasound sensor. The ultrasound sensor can be an M-mode sensor. The ultrasonic sensor can be a B-mode sensor. The ultrasonic sensor can be a low-power sensor. The antenna can be a loop antenna. The antenna can be a conformal antenna. In one embodiment, the antenna provides data transmission. The antenna can continuously transmit sensor data. The antenna can intermittently transmit sensor data. The at least one sensor can continuously detect one or more physiological parameters. The at least one sensor can intermittently detect one or more physiological parameters. The spinal implant assembly can include a power source for providing power to the at least one sensor. Thus, the power source may be rechargeable. The at least one sensor can be powered by a power source outside the patient's body. In one embodiment, the antenna can be a secondary capacitance or inductive power receiver for battery charging.The spinal implant assembly may include a memory device for storing data from the at least one sensor.

[0012] In some aspects, a method for 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 patient movement and generating sensor data. The method can include transmitting the sensor data to a receiver at a remote location and receiving the data from the receiver.

[0013] The method for sampling data may include one or more of the following steps and features. The method may include detecting one or more kinematic measurements occurring during patient movement. The method may include detecting one or more kinematic measurements occurring when the interbody spacer or 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 while the patient is in a seated position. The predetermined angle may be 30 degrees, 45 degrees, or 90 degrees. The one or more kinematic measurements may be used to determine fusion of the interbody spacer or spinal cage. The one or more kinematic measurements may be used to determine subsidence of the interbody spacer or spinal cage. The one or more kinematic measurements may be used to determine translation of the interbody spacer or spinal cage. The translation of the interbody spacer or spinal cage may be used to measure translation of the interbody spacer or spinal cage at the implantation point. One or more kinematic measurements can be used to determine patient movement. The determined patient movement can include, for example, one of step count, cadence, walking speed, angle of movement, and gait. The method can be configured to determine how quickly the patient can return to normal activity. The implantable cartridge of the method can include at least one sensor capable of detecting one or more kinematic measurements associated with the patient and generating sensor data. The implantable cartridge can include an antenna in electrical communication with the at least one sensor. The antenna can transmit the sensor data to a receiver at a remote location and receive the data from the receiver. The implantable cartridge can include a battery. The method can include detecting one or more kinematic measurements, including obtaining one or more kinematic measurements from an inertial measurement unit having multiple accelerometers and / or multiple gyroscopes. The method can include detecting tilt using a tilt sensor. The tilt sensor can be used to detect angular movement of the implant.The method may include detecting deflections on the implant through the use of strain sensors. The method may include measuring data related to a first measurement axis, the data related to the first measurement axis being obtained from a first accelerometer and a first gyroscope of an inertial measurement unit. The method may include measuring data related to a second measurement axis, the data related to the second measurement axis being obtained from a second accelerometer and a second gyroscope of the inertial measurement unit. The method may include measuring data related to a third measurement axis, the data related to the third measurement axis being 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.

[0014] In some aspects, a spinal implant assembly for use in spinal fusion is disclosed. The spinal implant assembly can include a spinal implant. The spinal implant can include a body. The spinal implant can also include an opening at a first end of the body. The spinal implant can include a cavity extending through the body of the spinal implant from the opening toward a second end of the body. The spinal implant can include a cartridge configured to be inserted into the cavity, the cartridge including an outer wall configured to house a plurality of components.

[0015] 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 with the cartridge. The spinal implant may include at least one of a top surface of the body or a bottom surface of the body, including a plurality of ridges, the plurality of ridges configured to improve 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 certain aspects, the hole in the spinal implant is configured to be filled with a biological or synthetic material to assist in spinal fusion. In certain aspects, the spinal implant is an interbody spacer or a spinal cage.

[0016] In certain 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 the at least one sensor. The power source may include either a single-use or rechargeable battery. The cartridge may include an antenna. In certain aspects, the antenna may be positioned on the cartridge within the opening of the spinal implant. For example, the antenna may be positioned within an outer wall of the cartridge. In certain 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 certain aspects, the cartridge may include at least one sensor. In some examples, the at least one sensor is an ultrasound sensor. In some embodiments, the ultrasound sensor is a low-power sensor. In some examples, the at least one sensor continuously or intermittently detects one or more physiological parameters.

[0017] The cartridge may have one or more of the following features: In some embodiments, the cartridge may include a length with a circular, oval, 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 a width-to-height ratio of 1:2. The cartridge may have a width-to-height 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.

[0018] In some embodiments, the spinal implant can include a locking structure. In some embodiments, the locking structure can include locking spring fingers configured to deform outward on the spinal implant as the cartridge is inserted and configured to return to a predetermined position when the cartridge is fully inserted. In some examples, the locking structure can include a pin positioned on the spinal implant and a locking ledge positioned on the cartridge, where the pin on the spinal implant is configured to retain the locking ledge to retain the cartridge after insertion. In some embodiments, the locking ledge has a radius of the pin. In some embodiments, the locking structure can include a clip or groove positioned along the length of the cartridge, where the clip or groove is configured to retain the cartridge within the spinal implant.

[0019] In certain aspects, an intelligent implant assembly for implantation into a patient is disclosed. The intelligent implant assembly can include an implant body and a cartridge. In some embodiments, the implant body can include an opening on a first end of the implant body. The implant body can include a cavity extending through the implant body from the opening toward a second side of the implant body. In some examples, the cartridge can be inserted into the intelligent implant, and the cartridge is retained within the cavity of the implant body and within the outer periphery of the implant body. In some embodiments, the cartridge can include an outer wall configured to accommodate multiple components. In certain aspects, the intelligent implant assembly can include a locking structure for securing the spinal implant with the spinal implant. In some aspects, at least one of the left side of the body or the right side of the implant body includes multiple ridges, the multiple ridges configured to improve engagement of the spinal implant with adjacent vertebrae.

[0020] The cartridge may have one or more of the following features: In some embodiments, the cartridge includes a power source. The power source may include either a single-use or rechargeable battery. The cartridge may include an antenna. The antenna may be positioned on the cartridge within the opening of the spinal implant. The antenna may be positioned within an outer wall of the cartridge. The antenna may be at least one of a loop antenna and a conformal antenna. The antenna may continuously transmit sensor data. The antenna may intermittently transmit sensor data. In some embodiments, the cartridge includes a processor. In some embodiments, the cartridge 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 at least one sensor may continuously or intermittently detect one or more physiological parameters. In some embodiments, the cartridge may include a memory device for storing data from the at least one sensor. The cartridge may have a circular, oval, square, or rectangular cross-section and length. In some embodiments, the cartridge has an outer wall having a wall thickness of about 0.5 mm. The outer wall may have a wall thickness of less than 1 mm. In some examples, the cartridge has a width to height ratio of 1:2. In some embodiments, the cartridge has a width to height ratio of 2:3. The cartridge can be reversibly coupled to the spinal implant.

[0021] The locking structure may have one or more of the following features. For example, the locking structure comprises locking spring fingers configured to deform outward on the spinal implant as the cartridge is inserted and configured to return to a home position when the cartridge is fully inserted. In some examples, the locking structure comprises a pin positioned on the spinal implant and a locking ledge positioned on the cartridge, where the pin on the spinal implant is configured to retain the locking ledge to retain the cartridge after insertion. In some embodiments, the locking ledge has a radius of the pin. The locking structure can include a clip or groove positioned along the length of the cartridge, where the clip or groove is configured to retain the cartridge within the spinal implant.

[0022] In some embodiments, a method for monitoring patient recovery after spinal fusion is disclosed. The method can include providing a spinal implant assembly including a spinal implant and a cartridge, the cartridge including at least one sensor. In some examples, the method can include collecting, with 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 can include transmitting the data to a remote location. In some embodiments, the data includes kinematic measurements of patient movement. The data can be indicative of movement of the spinal implant.

[0023] The spinal implant may comprise an opening and a cavity on a first end of the spinal implant, the cavity extending through the body from the first end of the spinal implant to a second end of the spinal implant. The cartridge may be configured to be inserted into the opening of the spinal implant such that the cartridge is secured within the cavity of the spinal implant. In some embodiments, the cartridge comprises a power source, a memory source, and a processor. In some examples, one of the at least one sensor comprises an accelerometer and / or a gyroscope. In some examples, one of the at least one sensor comprises an accelerometer and / or a gyroscope and / or a tilt sensor and / or a strain sensor. The accelerometer and / or gyroscope may be configured to measure at least one of the patient's steps, cadence, walking speed, angle of movement, or gait. In some embodiments, one of the at least one sensor comprises at least one ultrasonic sensor. The at least one ultrasonic sensor may be configured to detect translation of the spinal implant. In some embodiments, the translation of the spinal implant may be configured to measure movement of the spinal implant from the point of implantation in the patient. In some embodiments, the at least one ultrasonic sensor is configured to measure the distance between a surface of the spinal implant and an adjacent vertebra. In some examples, 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. In some embodiments, the at least one sensor comprises at least one tilt sensor. In some embodiments, the at least one sensor comprises at least one strain sensor or other sensor that measures deflection. The tilt sensor and / or strain sensor may be utilized to detect, for example, angular movement. In some embodiments, the 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 relative to the adjacent vertebra. The acoustic emissions may be configured to measure fusion of the spinal implant relative to the adjacent vertebra.In some embodiments, the at least one sensor is configured to calibrate the cartridge when the patient is in a known position. In some examples, the spinal implant is an interbody spacer or a spinal cage.

[0024] In certain aspects, a method for monitoring patient recovery after spinal fusion is disclosed. The method can include receiving data from a spinal implant assembly. The method can include processing the data to assess spinal implant migration, spinal implant subsidence, and / or spinal implant fusion. The method can include providing an output to a clinician based on the processed data.

[0025] In some embodiments, the data may include kinematic measurements. The patient's kinematic measurements may be associated with at least one of the patient's step count, cadence, walking speed, angle of movement, or gait. The data may include measurements indicative of spinal implant movement. In some embodiments, the method may include determining the spinal implant movement based on translational movement of the spinal implant. In some embodiments, the data includes measurements indicative of spinal implant subsidence. In some examples, the method further includes determining the spinal implant subsidence based on a change in distance between a surface of the spinal implant and an adjacent vertebra. In some examples, the data includes measurements indicative of fusion of the spinal implant with an adjacent vertebra.

[0026] Exemplary features of the present disclosure, its nature, and various advantages will be apparent from the accompanying drawings and the following detailed description of various embodiments. Non-limiting and non-exhaustive embodiments are described with reference to the accompanying drawings, in which like labels or reference numbers refer to like parts throughout the various views unless otherwise specified. The sizes and relative positions of elements in the drawings are not necessarily drawn to scale. For example, the shapes of various elements are selected, enlarged, and positioned to improve legibility of the drawings. The particular shapes of the depicted elements are selected for ease of recognition in the drawings. One or more embodiments are described below with reference to the accompanying drawings. [Brief explanation of the drawings]

[0027] [Figure 1A] 1 illustrates an implantable sensor assembly in the form of an interbody spacer having an insertable cartridge, the cartridge including an implantable reporting processor. [Figure 1B] FIG. 1B shows a perspective view of the insertable cartridge of FIG. 1A. [Figure 1C] FIG. 1B shows a perspective view of the insertable cartridge of FIG. 1A. [Figure 2A] 1 illustrates another implantable sensor assembly in the form of an interbody spacer having an insertable cartridge, the cartridge including an implantable reporting processor. [Figure 2B] 2B shows a cross-sectional view of the insertable cartridge of FIG. 2A. [Figure 2C] 2B shows a cross-sectional view of the insertable cartridge of FIG. 2A. [Figure 2D] 2B shows a cross-sectional view of the insertable cartridge of FIG. 2A. [Figure 3] 1 illustrates an implantable sensor assembly in the form of an interbody spacer having an insertable cartridge, wherein the spinal cage includes a window. [Figure 4A] FIG. 1C shows a cross-sectional medial side view of the implantable sensor assembly of FIGS. 1A and 1B. [Figure 4B] FIG. 2C shows a cross-sectional medial side view of the implantable sensor assembly of FIGS. 2A and 2B. [Figure 5A] FIG. 1 illustrates a front-posterior anterior view of an implantable sensor assembly having a spinal cage with an insertable cartridge, wherein the interbody spacer does not include a window. [Figure 5B] 1 illustrates a front-posterior anterior view of an implantable sensor assembly having a spinal cage with an insertable cartridge, and an interbody spacer including a window. [Figure 6] 1A, 1B, 1C, 2A, 2B, 3, 4A, 4B, 5A, and 5B implanted in a patient's spine during spinal fusion. [Figure 7] Context diagram of the intelligent implant environment in the patient's home. [Figure 8] 1 shows a block diagram of an implantable circuit for an implantable sensor assembly, such as an implantable interbody spacer, the circuit including an implantable reporting processor (IRP). [Figure 9] 1 shows another block diagram of an implantable circuit for an implantable sensor assembly, such as an implantable interbody spacer, the circuit including an implantable reporting processor (IRP). [Figure 10] 10 illustrates an inertial measurement unit (IMU) of the implantable reporting processor of FIGS. 8 and 9 and a set of coordinate axes within the reference frame of the IMU. [Figure 11A] 1 shows various views of a loop antenna; [Figure 11B] 1 shows various views of a loop antenna; [Figure 11C] 1 shows various views of a loop antenna; [Figure 11D] 1 shows various views of a loop antenna; [Figure 11E] 1 shows various views of a loop antenna; [Figure 12] 1 illustrates a conformal antenna according to certain aspects of the present disclosure. [Figure 13] 1 illustrates an embodiment of a planar inverted-F (PIFA) antenna in accordance with certain aspects of the present disclosure. [Figure 14] 1 illustrates an embodiment of a helical antenna. [Figure 15] FIG. 1 shows a block diagram of an implantable circuit for an implantable sensor assembly, such as an implantable interbody spacer. [Figure 16A] FIG. 10 shows a front-posterior-anterior view of another embodiment of an implantable sensor assembly including an interbody spacer with an insertable cartridge. [Figure 16B] FIG. 16B shows a posterior-anterior view of the implantable sensor assembly of FIG. 16A. [Figure 16C] 16B shows a side view of another embodiment of the implantable sensor assembly of FIG. 16A. [Figure 16D] FIG. 16B illustrates a front perspective view of the implantable sensor assembly of FIG. 16A. [Figure 16E] FIG. 16B illustrates a rear perspective view of the implantable sensor assembly of FIG. 16A. [Figure 16F] 16B shows a top view of the implantable sensor assembly of FIG. 16A. [Figure 16G] FIG. 16B shows a bottom view of the implantable sensor assembly of FIG. 16A. [Figure 16H] 16F shows a cross-sectional view of the implantable sensor assembly taken solely through line AA of FIG. 16F and an insertable cartridge positioned within an opening in the implantable sensor assembly. [Figure 16I] FIG. 16C shows a cross-sectional view of the implantable sensor assembly of FIG. 16H with the insertable cartridge removed. [Figure 17] 10 shows a perspective view of another embodiment of an implantable sensor assembly with an implantable reporting processor inserted therein. [Figure 18] 18A-16I and 17 show schematic diagrams of an implantable report processor cartridge for insertion into the interbody spacer shown in FIG. 17. [Figure 19A] 19 illustrates an embodiment of a locking structure for retaining the cartridge of FIG. 18 within an interbody spacer. [Figure 19B] 19 illustrates another embodiment of a locking structure for retaining the cartridge of FIG. 18 within an interbody spacer. [Figure 19C] 19 illustrates another embodiment of a locking structure for retaining the cartridge of FIG. 18 within an interbody spacer. [Figure 20A] 10 shows a cross-sectional view of a cartridge with an antenna positioned within an interbody spacer. [Figure 20B] 20B shows a front view of a cartridge with an antenna positioned within the interbody spacer of FIG. 20A. DETAILED DESCRIPTION OF THE INVENTION

[0028] 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. When spinal implants, devices such as interbody spacers and spinal cages, are inserted into a patient, physicians must determine whether the surgery helped address the patient's condition. A successful surgery should allow the patient to return to normal activities with minimal pain. Traditionally, to evaluate the success of a spinal implant, physicians rely on patients who indicate they are experiencing pain or have difficulty resuming activities as a measure of their condition. However, relying on patient feedback can be limited because physicians do not understand how to articulate the discomfort they are experiencing. Similarly, patients can be unreliable narrators of physical activity. Similarly, relying solely on indirect measurements is limited because physicians cannot diagnose problems related to spinal surgery and issues related to the position of the spinal implant. For example, interbody spacers or spinal cages can migrate (i.e., move away from the implantation point) and / or subside (i.e., decrease in the vertical height of the disc space before fusion is complete) postoperatively, causing pain to the patient.

[0029] The sensor assembly of the present disclosure is configured to allow a physician to indirectly and / or directly measure a patient's recovery. The sensor assembly can measure a patient's condition by indirectly monitoring the patient's general movement and lifestyle changes. For example, if a patient is unable to return to activities they previously enjoyed, this is likely a sign that the spinal implant did not address their condition. Similarly, if a patient experiences pain, changes in gait, or significantly reduces physical activity, this may also be an indirect measure that the patient continues to experience back pain and that the spinal implant has not addressed their condition. As discussed in more detail below, the spinal implant includes multiple sensors that allow a physician to determine whether a patient's general mobility has changed. This may include, for example, changes in how often the patient walks, whether the patient is stomping, and whether the patient has a change in gait (e.g., standing up). When combined with lifestyle information from the patient (e.g., experiencing pain or continued participation in enjoyable activities), these changes may alert the patient that additional surgery may be necessary to address their condition.

[0030] However, indirect measurements of a patient's condition can be limited because they do not respond to the "why" of the patient's pain. As discussed, the disclosed sensor assembly includes several sensors that can determine whether fusion between vertebrae has occurred, whether a spinal implant has migrated, and / or whether a spinal implant is experiencing subsidence. This additional information can provide a physician the ability to more accurately and precisely diagnose a patient's condition and pain experienced.

[0031] Integrated sensor technology is disclosed for spinal fusion procedures via implantable interbody and / or posterior fusion devices that provides clinically relevant, objective data post-operatively (a similar subset of data may be captured pre-operatively using a wearable device containing the same sensors). Multiple sensors (accelerometers, gyroscopes, force gauges, strain gauges, temperature sensors, etc.) within the implanted device (or wearable) passively or on-demand collect raw data that can be uploaded to a cloud infrastructure for processing into clinical metrics, which can then be displayed on a designated user interface.

[0032] In some embodiments, the processed data provides metrics as a tool for physicians to monitor their patients. Processed data measured from algorithms and methods directed at patient movement may yield, but are not limited to, step count (steps / day), distance walked / day, average walking speed, spinal angle, patient position (lying, restrained, or upright), and spinal range of motion.

[0033] In some embodiments, the processed and analyzed data collected from the intelligent implant can provide patient outcome monitoring, such as fusion rate or early detection of complications (e.g., loosening / malfusion, subsidence, migration) in an intelligent implant, such as a spinal implant. Multiple analyses and calculations can be used to determine these indicators. For example, to detect fusion rate, vibration analysis is algorithmically performed utilizing in vivo prosthesis vibration data from an accelerometer (or other sensor). This vibration can be explicitly detected and correlated with established moments in the gait cycle (i.e., heel strike, neutral, toe off, etc.) or other established mobility movements. By relating the vibration pattern to known movements, precise moments of interest can be analyzed. When analyzing spinal fusion over time, vibration amplitude decreases as bone grows and fuses adjacent vertebrae, thus indicating spinal fusion.

[0034] The present disclosure may be more readily understood by reference to the following detailed description of embodiments of the present disclosure and examples of implantable medical devices having an implantable report processor. The following description, along with the accompanying drawings, sets forth certain specific details to provide a thorough understanding of various disclosed embodiments. However, those skilled in the art will recognize that the disclosed embodiments may be practiced without one or more of these specific details, or with other methods, components, devices, materials, and the like, in various combinations. In other instances, well-known structures or components relevant to the environment of the present disclosure, including but not limited to communication systems and networks, are not shown or described to avoid unnecessarily obscuring the description of the embodiments.

[0035] This disclosure refers to surgical procedures, e.g., spinal procedures such as spinal fusion, which term can refer to surgical procedures and related implantable medical devices such as spinal implant systems (e.g., spinal fusion implants such as intersomatic cages or spacers, rods or plates, or spinal non-fusion implants such as artificial discs or expandable rods).

[0036] Before describing the present disclosure in more detail, an understanding thereof may be helpful to provide definitions of certain terms used herein. Additional definitions are provided throughout this disclosure. The terms "comprise" and "comprises," and their derivatives, mean inclusion, without limitation. The term "or" is inclusive, connotative, and / or. The terms "associated" and "associated with," and their derivatives, may mean including, contained within, interconnected, containing, included in, connected to, coupled with, or in communication with, cooperating with, interleaving, juxtaposing, adjacent to, or coupled with, having, having properties of, or the like. The terms "controller" or "processor" refer to any device, system, or portion thereof that controls at least one operation; such a device may be implemented in hardware (e.g., electronic circuitry), firmware, or software, or any combination of at least two of them. The functionality associated with any particular controller may be local or remote, centralized or distributed. Other definitions of particular words and phrases may be provided within this patent document, and those skilled in the art will understand that in many cases, if not most, such definitions apply to previous and future uses of such defined words and phrases.

[0037] As used in this disclosure, an "intelligent medical device" is an implantable or implanted medical device that desirably replaces or functionally complements a subject's natural body part. As used herein, the term "intelligent implant" refers to an implantable medical device having an implantable reporting processor. An "intelligent implant" is interchangeably referred to as an "implantable sensor assembly" or a "smart device."

[0038] In some embodiments, the intelligent implant is an implant or implantable medical device having an implantable reporting processor arranged to perform the functions described herein. The intelligent implant may perform one or more of the following exemplary operations to characterize the post-implant status of the intelligent implant: identifying the intelligent implant or portion of the intelligent implant, for example, by recognizing one or more unique identification codes for the intelligent implant or portion of the intelligent implant; detecting, sensing, and / or measuring parameters that may collectively be referred to as monitoring data, such as operational, kinematic, or other data related to the intelligent implant or portion of the intelligent implant, which may optionally be collected as a function of time; storing the collected data within the intelligent implant or portion of the intelligent implant; and communicating the collected and / or stored data from the intelligent implant or portion of the intelligent implant by wireless means to an external computing device. The external computing device may have access to at least one data storage location, such as a personal computer, a base station, a computer network, a cloud-based storage system, or another computing device with access to such storage, or may otherwise have access to such storage.

[0039] As used herein, "kinematic data," individually or collectively, includes some or all data associated with a particular intelligent implant and available for communication outside of the particular intelligent implant. For example, kinematic data may include raw data from one or more sensors of the intelligent implant, including gyroscopes, accelerometers, speedometers, strain gauges, etc., that generate data related to motion, force, tension, velocity, or other mechanical forces. Kinematic data may also include processed data, status data, operational data, control data, fault data, time data, scheduled data, event data, log data, etc., from one or more sensors associated with a particular intelligent implant. In some cases, high-resolution kinematic data involves monitoring data from one, many, or all of an intelligent implant's sensors, collected in greater volume, at greater resolution, from more sensors, more frequently, or the like.

[0040] In some embodiments, kinematics refers to the measurement of position, angle, velocity, and acceleration of body segments and joints during motion. Position describes the location of a body segment or joint in space, measured in terms of distance in meters, for example. A related measurement called displacement refers to position relative to a starting position. In two dimensions, position is given in Cartesian coordinates, with horizontal followed by vertical position.

[0041] "Sensor" refers to a device that can be utilized to detect, measure, and / or monitor one or more of: 1) one or more different aspects of body tissue (anatomy, physiology, metabolism, and / or function); 2) one or more aspects of the state or function of the body or body segment / joint (healing, movement including measuring position, angle, velocity, and acceleration of body segments and joints); and / or 3) one or more aspects of an implant. Representative examples of sensors suitable for use within the present disclosure include, for example, fluid pressure sensors, fluid volume sensors, contact sensors, position sensors, pulse pressure sensors, blood volume sensors, blood flow sensors, chemical sensors (e.g., for blood and / or other fluids), metabolic sensors (e.g., for blood and / or other fluids), accelerometers, mechanical stress sensors, and temperature sensors. In certain embodiments, the sensors may be wireless sensors, or in other embodiments, sensors connected to a wireless microprocessor. In further embodiments, one or more (including all) of the sensors may have a unique sensor identification number (USI) that uniquely identifies the sensor. In certain embodiments, the sensor is a device that can be utilized to measure a quantitative manner, one or more different aspects of a body tissue (anatomy, physiology, metabolism, and / or function), and / or one or more aspects of an implant. In certain embodiments, the sensor is an accelerometer that can be utilized to measure a quantitative manner, one or more different aspects of a body tissue (e.g., function), and / or one or more aspects of an implant (e.g., patient alignment).

[0042] A wide variety of sensors (also known as Microelectromechanical Systems or MEMS, or Nanoelectromechanical Systems or NEMS, and BioMEMS or BioNEMS) may be utilized within the present disclosure.

[0043] Intelligent Implant System An intelligent implant system includes one or more of the following: 1) sensors that detect and / or measure the function of the implant and / or the immediate environment surrounding the implant and / or the patient's activity, 2) a memory that stores data from the detection and / or measurement, 3) an antenna that transmits the data, 4) a base station that can receive the data generated by the sensors and transmit the data and / or analyzed data to a cloud-based location, 5) a cloud-based location where the data can be stored and analyzed, and the analyzed data can be stored and / or further analyzed, and 6) a receiving terminal that receives output from the cloud-based location, where the receiving terminal can be accessed by, for example, a medical professional, an insurance company, or the implant manufacturer, and the output may identify the condition of the implant and / or the function of the implant and / or the condition of the patient who received the implant, and may also provide recommendations to address concerns raised by the analysis of the original data.

[0044] 7 shows a context diagram of the intelligent implant environment 1000. It should be recognized that individual components of the implant environment 1000 are not essential or required. Any component described herein may be implemented using any device suitable for performing the recited functions.

[0045] In this environment, an intelligent implant 1002 is implanted in a patient's body (not shown in FIG. 7 ) by a medical professional (not shown in FIG. 7 ). The intelligent implant 1002 has an associated (IRP) that is positioned and configured to collect data including, for example, medical and health data related to the patient with whom the device is associated, motion data of the device 1002 along with kinematic data related to specific movements of the patient or specific movements of portions of the patient's body, and motion data of the device 1002 itself. The intelligent implant 1002 can communicate with one or more base stations 1004 or one or more smart devices 1005 during different stages of monitoring the patient.

[0046] For example, in connection with a medical procedure, an intelligent implant 1002 is implanted into a patient's body. In parallel with the medical procedure, the intelligent implant 1002 communicates with a base station (not shown in FIG. 7 ) in an operating room. Later, after sufficiently recovering from the medical procedure, the patient returns home, and the intelligent implant 1002 is positioned to communicate with a home base station 1004. It is understood that the home base station may be a separate device or may be a smartphone with a customized application including software that enables communication with the smart implant. At other times, the intelligent implant 1002 is positioned to communicate with a base station (not shown in FIG. 7 ) in a clinic. The intelligent implant 1002 communicates with each base station 1004 via a short-range network protocol, such as the Medical Implant Communication Service (MICS), Medical Device Wireless Communication Service (MedRadio), or any other wireless communication protocol suitable for use with the intelligent implant 1002.

[0047] The intelligent implant 1002 includes one or more measurement units for collecting information and data related to the use of the body part with which the intelligent implant 1002 is associated. In some embodiments, the collected information and data is medical and health data related to the patient with whom the device is associated. For example, the intelligent implant 1002 may include an inertial measurement unit including a gyroscope, accelerometer, pedometer, or other motion sensor for collecting acceleration data in the medial / lateral, anterior / posterior, anterior / inferior axis of the associated body part, angular velocity in the sagittal, frontal, or transverse plane of the associated body part, force, stress, tension, pressure, stress, movement, vibration, flexion, stiffness, or other measurable data.

[0048] The intelligent implant 1002 collects data at different times and at different rates during the patient monitoring process. In some embodiments, the intelligent implant 1002 may operate at multiple different stages in the process of monitoring a patient, such that more data is collected immediately after the intelligent implant 1002 is implanted in the patient, and less data is collected as the patient heals and thereafter.

[0049] The amount and type of data collected by intelligent implant 1002 may vary from patient to patient, and the amount and type of data collected may vary for a single patient. For example, a medical professional studying data collected by intelligent implant 1002 for a particular patient may adjust or otherwise control how intelligent implant 1002 collects future data.

[0050] The amount and type of data collected by intelligent implant 1002 may vary for different body parts, different types of patient conditions, different patient demographic characteristics, or other differences. Alternatively, or additionally, the amount and type of data collected may change over time based on other factors such as how the patient is healing or feeling, how long the monitoring process will last, how much battery power is remaining and should be conserved, the type of movement being monitored, the body part being monitored, etc. In some cases, the collected data may be supplemented with personal descriptive information provided by the patient, such as subjective pain data, quality of life indicator data, comorbidities, perceptions, or expectations that the patient associates with intelligent implant 1002, etc.

[0051] In some embodiments, the intelligent implant 1002 is implanted into a patient to monitor the movement or other aspects of a particular body part or of the intelligent implant 1002 itself. The implantation of the intelligent implant 1002 into a patient may occur in an operating room. As used herein, an operating room includes any office, room, building, or facility in which the intelligent implant 1002 may be implanted into a patient. For example, the operating room may be a typical operating room in a hospital, an operating room in a surgical clinic or doctor's office, or any other operating room, interventional room, intensive care unit, emergency room, etc., where the intelligent implant 1002 is implanted into a patient.

[0052] An operating room base station (not shown in FIG. 7 ) is utilized in association with an intelligent implant 1002 implanted within a patient to configure and initialize the intelligent implant 1002. A communication relationship may be formed between the intelligent implant 1002 and the operating room base station, for example, based on polling signals transmitted by the operating room base station and response signals transmitted by the intelligent implant 1002.

[0053] Upon establishing a communication relationship, which often occurs prior to implantation of the intelligent implant 1002, the operating room base station (not shown in FIG. 7) transmits initial configuration information to the intelligent implant 1002. This initial configuration information may include, but is not limited to, a timestamp, a date stamp, identification of the type and placement of the intelligent implant 1002, information about other implants associated with the intelligent implant, surgeon information, patient identification, operating room information, etc.

[0054] In some embodiments, the initial configuration information is passed unidirectionally, while in other embodiments, the initial configuration is passed bidirectionally. The initial configuration information may define at least one parameter associated with the collection of data by the intelligent implant 1002. For example, the configuration information may identify the settings of one or more sensors on the intelligent implant 1002 for each of one or more operating modes (e.g., accelerometer range, accelerometer output data rate, gyroscope range, gyroscope output data rate, etc.). The configuration information may also include other control information, such as the initial operating mode of the intelligent implant 1002, specific events that trigger a change in operating mode, wireless settings, data collection information (e.g., how often the intelligent implant 1002 wakes up to collect data, how long to collect data, and how much data to collect), identities of the home base station 1004, smart device 1005, and connected personal assistant 1007, and other control information related to the implantation or operation of the intelligent implant 1002. Examples of connected personal assistants 1007, which may also be called smart speakers, include Neak Echo®, Neak Dot®, Google Home®, Neak® patient monitors, Comcast health tracking speakers, and Apple Home Pod®.

[0055] In some embodiments, the initial configuration information may be pre-stored on the operating room base station (not shown in FIG. 7 ) or an associated computing device. In other embodiments, a surgeon, surgical technician, or some other medical personnel may input control information and other parameters into the operating room base station for transmission to the intelligent implant 1002. In some embodiments, in at least one such configuration, the operating room base station may communicate with an operating room-configured computing device (not shown in FIG. 7 ). The operating room-configured computing device includes an application having a graphical user interface that allows medical personnel to input configuration information for the intelligent implant 1002. In various embodiments, the application running on the operating room-configured computing device may have portions of pre-defined configuration information that may or may not be adjustable by medical personnel.

[0056] The operating room-configured computing device (not shown in FIG. 7) can communicate configuration information via a wired or wireless network connection (e.g., a USB connection, a Bluetooth connection, a Bluetooth Low Energy (BTLE) connection, or a Wi-Fi connection) to the operating room base station (not shown in FIG. 7), which can communicate to the intelligent implant 1002.

[0057] The operating room configuration computing device (not shown in FIG. 7) may also display information about the intelligent implant 1002 or the operating room base station (not shown in FIG. 7) to the surgeon, surgical technician, or other medical personnel. For example, the operating room configuration computing device may display error information if the intelligent implant 1002 cannot store or access configuration information, if the intelligent implant 1002 is unresponsive, if the intelligent implant 1002 identifies a problem with one of its sensors or radios during an initial self-test, if the operating room base station (not shown in FIG. 7) is unresponsive or malfunctioning, or for other reasons.

[0058] Although the operating room base station (not shown in FIG. 7) and the operating room configuration computing device (not shown in FIG. 7) are described as separate devices, embodiments are not so limited; rather, as shown, the functionality of the operating room configuration computing device and the operating room base station may be included within a single computing device or within separate devices. In this manner, medical personnel may, in one embodiment, be able to enter configuration information directly into the operating room base station.

[0059] Returning to FIG. 7 , once the intelligent implant 1002 is implanted into the 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 1007, or two or more of the home base station and the computing or smart device and the connected personal assistant can communicate with the intelligent implant 1002. The intelligent implant 1002 can collect data at a determined rate and time, a variable rate and time, or an otherwise controllable rate and time. Data collection can begin when the intelligent implant 1002 is initialized in the operating room, when directed by medical personnel, or at some later point. At least some data collected by the intelligent implant 1002 may be transmitted directly to the home base station 1004, to the smart device 1005, to the directly connected personal assistant 1007, to the base station via one or both of the smart device and the connected personal assistant, to the smart device via one or both of the base station and the connected personal assistant, or to the connected personal assistant via one or both of the smart device and the base station. Here, either or both means via only one item, and via both items serially or in parallel. For example, data collected by the intelligent implant 1002 may be transmitted to the home base station 1004 via only the smart device 1005, only the connected personal assistant 1007, serially via the smart device and the connected personal assistant, serially via the connected personal assistant and the smart device, and directly via both the smart device and the connected personal assistant, and possibly simultaneously.Similarly, data collected by the intelligent implant 1002 may be transmitted to the smart device 1005 only through the home base station 1004, only through the connected personal assistant 1007, serially through the home base station and the connected personal assistant, serially through the connected personal assistant and the home base station, or even through both the home base station and the connected personal assistant. Furthermore, in embodiments, data collected by the intelligent implant 1002 may be transmitted to the connected personal assistant 1007 only through the smart device 1005, only through the home base station 1004, serially through the smart device and the home base station, serially through the home base station and the smart device, and possibly simultaneously through both the smart device and the home base station.

[0060] In various configurations, one or more of the home base station 1004, the smart device 1005, and the connected personal assistant 1007 can ping the intelligent implant 1002 periodically, at predetermined, or other times to determine whether the intelligent implant 1002 is within communication range with one or more of the home base station, the smart device, and the connected personal assistant. Based on the response from the intelligent implant 1002, the one or more of the home base station 1004, the smart device 1005, and the connected personal assistant 1007 can determine that the intelligent implant 1002 is within communication range, and the intelligent implant 1002 can request, command, or otherwise instruct the one or more of the home base station 1004, the smart device 1005, and the connected personal assistant 1007 to transmit collected data.

[0061] One or more of the home base station 1004, smart device 1005, and connected personal assistant 1007 may each be configured with a respective optional user interface in some cases. The user interface may be configured as a multimedia interface for passing one or more types of multimedia information (e.g., video, audio, tactile, etc.) unidirectionally or bidirectionally. Through the respective user interfaces of the home base station 1004, smart device 1005, and connected personal assistant 1007, the patient (not shown in FIG. 7) or a patient associate (not shown in FIG. 7) may input other data to supplement the data collected by the intelligent implant 1002. The user may input, for example, personal descriptive information (e.g., age change, weight change), changes in medical condition, co-morbidities, pain level, quality of life, indicators of how the implantable device 1002 “feels,” or other subjective indicator data, a personal message for a healthcare professional, etc. In these embodiments, the personal descriptive information may be entered with a keyboard, mouse, touchscreen, microphone, wired or wireless computing interface, or some other input means. If personal descriptive information is collected, the personal descriptive information may include or be otherwise associated with one or more identifiers that associate the information with a unique identifier of the intelligent implant 1002, the patient, an associated medical professional, an associated medical facility, etc.

[0062] In some of these cases, the optional user interface of one or more of the home base station 1004, smart device 1005, and connected personal assistant 1007 may also be arranged to deliver information associated with the intelligent implant 1002 to the user, for example, from a healthcare professional. In these cases, the information delivered to the user may be delivered via means such as a video screen, an audio output device, a tactile transducer, a wired or wireless computing interface, etc.

[0063] In some embodiments, in configurations where one or more of the home base station 1004, smart device 1005, and connected personal assistant 1007 are configured with a user interface, the user interface may be formed with an internal user interface that is configured for communicative coupling to a patient portal device. The patient portal device may be a smartphone, tablet, body-worn device, weight or other health measurement device (e.g., thermometer, scale, etc.), or some other computing device capable of wired or wireless communication. In these embodiments, a user may enter personal descriptive information, and the user may receive information associated with the implantable device 1002.

[0064] The home base station 1004 can transmit the collected data to the cloud 1008 using the patient's home network 1006. The home network 1006, which may be a local area network, provides access from the patient's home to a wide area network, such as the Internet. In some embodiments, the home base station 1004 may use a Wi-Fi connection to connect to the home network 1006 and access the Internet. In other embodiments, the home base station 1004 may be connected to the patient's home computer (not shown in FIG. 7 ), such as via a USB connection, which is itself connected to the home network 1006.

[0065] The smart device 1005 may communicate directly with the intelligent implant 1002, for example, via Bluetooth®-enabled signals, may utilize the patient's home network 1006 to transmit collected data to the cloud 1008, or may communicate directly with the cloud, for example, via a cellular network. Alternatively, the smart device 1005 may be configured to communicate directly with one or both of the base station 1004 and the connected personal assistant 1007, for example, via Bluetooth®-enabled signals, and may not be configured to communicate directly with the intelligent implant 1002.

[0066] Additionally, the connected personal assistant 1007 may communicate directly with the intelligent implant 1002, e.g., via Bluetooth®-enabled signals, may utilize the patient's home network 1006 to transmit collected data to the cloud 1008, or may communicate directly with the cloud, e.g., via a modem / internet connection or cellular network. Alternatively, the connected personal assistant 1007 may be configured to communicate directly with one or both of the base station 1004 and the smart device 1005, e.g., via Bluetooth®-enabled signals, and may not be configured to communicate directly with the intelligent implant 1002.

[0067] In addition to transmitting collected data to the cloud 1008, one or more of the home base station 1004, the smart device 1005, and the connected personal assistant 1007 may also obtain data, commands, or other information from the cloud 1008 directly or via the home network 1006. One or more of the home base station 1004, the smart device 1005, and the connected personal assistant 1007 may provide some or all of the received data, commands, or other information to the intelligent implant 1002. Examples of such information include, but are not limited to, updated configuration information, diagnostic requests to determine whether the intelligent implant 1002 is functioning properly, data collection requests, and other information.

[0068] Cloud 1008 may include one or more server computers or databases for aggregating data collected from intelligent implants 1002 and, in some cases, personally descriptive information collected from the patient (not shown in FIG. 7 ), data collected from other intelligent implantable devices, and, in some cases, personally descriptive information collected from other patients. In this manner, cloud 1008 can create a variety of different metrics related to the data collected from each of multiple intelligent implants implanted in separate patients. This information can be useful in determining whether the intelligent implants are functioning properly. The collected information can also be useful for other purposes, such as determining which particular devices may not be functioning properly, determining whether a treatment or condition associated with the intelligent implant is assisting the patient, and other medical information.

[0069] At various points throughout the monitoring process, a medical professional may request a follow-up appointment with the patient. This medical professional may be the surgeon who implanted the intelligent implant 1002 into the patient or a different medical professional overseeing the patient's monitoring process, physical therapy, and recovery. For a variety of different reasons, the medical professional may desire to collect real-time data from the intelligent implant 1002 in a controlled environment. In some cases, the request to visit a medical professional may be delivered via any interactive user interface of one or more of the home base station 1004, the smart device 1005, and the connected personal assistant 1007, respectively.

[0070] The medical practitioner utilizes a clinic base station (not shown in FIG. 7 ) that communicates with the intelligent implant 1002 to pass additional data between the clinic base station and the intelligent implant 1002. In some embodiments, the medical practitioner utilizes the clinic base station (not shown in FIG. 7 ) to pass commands to the intelligent implant 1002. In some embodiments, the clinic base station commands the intelligent implant 1002 to enter a high-resolution mode to temporarily increase the rate or type of data collected in a short period of time. The high-resolution mode instructs the intelligent implant 1002 to collect different (e.g., larger amounts of) data during activities in which the medical practitioner is also monitoring the patient.

[0071] In some embodiments, the clinic's base station (not shown in FIG. 7 ) can allow a medical professional to input event or pain markers that can be synchronized with the high-resolution data collected by the intelligent implant 1002. For example, assume the intelligent implant 1002 is a component positioned in the spine. The medical professional can have the patient walk on a treadmill while the intelligent implant 1002 is in high-resolution mode. As the patient walks, the patient may complain of back pain. The medical professional can click a pain marker button on the clinic base station to indicate the patient's discomfort. The clinic's base station records the marker and the time the marker was entered. Once the timing of this marker is synchronized with the timing of the collected high-resolution data, the medical professional can analyze the data to determine the cause of the pain.

[0072] In other embodiments, the clinic's base station (not shown in FIG. 7 ) may provide updated configuration information to the intelligent implant 1002. The intelligent implant 1002 can store this updated configuration information, which may be used to adjust parameters associated with collecting data. For example, if the patient is performing well, the medical professional may instruct the intelligent implant 1002 to collect data less frequently. Conversely, if the patient is experiencing unexpected pain, the medical professional may instruct the intelligent implant 1002 to collect additional data for a determined period of time (e.g., several days). The medical professional may use the additional data to diagnose and treat the specific problem. In some cases, the additional data may include personal descriptive information (not shown in FIG. 7 ) provided by the patient after the patient leaves the medical professional's presence and is no longer within range of the clinic's base station. In these cases, the personal descriptive information may be collected and delivered from one or more of the home base station 1004, the smart device 1005, and the connected personal assistant 1007. The antenna within the intelligent implant and / or base station may provide protection to limit the duration of such enhanced monitoring and ensure that the battery retains sufficient power to last for the lifecycle of the implant.

[0073] In some embodiments, the clinic's base station (not shown in FIG. 7 ) may communicate with a clinic-configured computing device (not shown in FIG. 7 ). The clinic-configured computing device includes an application with a graphical user interface that allows a medical professional to input commands and data. Some or all of the commands, data, and other information may later be transmitted to the intelligent implant 1002 via the clinic's base station. For example, in some embodiments, the medical professional may use the graphical user interface to instruct the intelligent implant 1002 to enter its high-resolution mode. In other embodiments, the medical professional may use the graphical user interface to enter or modify configuration information for the intelligent implant 1002. The clinic-configured computing device may transmit information (e.g., commands, data, or other information) via a wired or wireless network connection (e.g., a USB connection, a Bluetooth® connection, or a Wi-Fi connection) to the clinic base station, which then transmits some or all of the information to the intelligent implant 1002.

[0074] The clinic-configured computing device (not shown in FIG. 7 ) may also display other information about the intelligent implant 1002 related to the patient (e.g., personal descriptive information) or the clinic's base station to the medical professional. For example, the clinic-configured computing device may display high-resolution data collected by the intelligent implant 1002 and transmitted to the clinic's base station (not shown in FIG. 7 ). The clinic-configured computing device may also display error information if the intelligent implant 1002 cannot store or access configuration information, if the intelligent implant 1002 is unresponsive, if the intelligent implant 1002 identifies a problem with one of its sensors or radios, if the physician's office base station is unresponsive or malfunctioning, or for other reasons.

[0075] In some embodiments, the clinic-configured computing device (not shown in FIG. 7 ) may have access to the cloud 1008. In at least one embodiment, a medical professional can utilize the clinic-configured computing device to access data stored in the cloud 1008 that was previously collected by the intelligent implant 1002 and transmitted to the cloud 1008 via one or both of the home base station 1004 and the smart device 1005. Similarly, the clinic-configured computing device can transmit high-resolution data obtained from the intelligent implant 1002 to the cloud 1008 via the clinic base station. In some embodiments, the clinic base station may have internet access and may allow high-resolution data to be transmitted directly to the cloud 1008 without the use of the clinic-configured computing device.

[0076] In some embodiments, a medical practitioner may update the configuration information of the intelligent implant 1002 when the patient is away from the clinic. In these cases, the medical practitioner can utilize a clinic configuration computing device (not shown in FIG. 7 ) to transmit the updated configuration information to the intelligent implant 1002 via the cloud 1008. One or more of the home base station 1004, the smart device 1005, and the connected personal assistant 1007 can retrieve the updated configuration information from the cloud 1008 and pass the updated configuration information to the cloud 1008. This allows the medical practitioner to remotely adjust the operation of the intelligent implant 1002 without the patient needing to come to the clinic. This may also allow the medical practitioner to send messages (not shown in FIG. 7 ) to the patient, for example, in response to personal descriptive information provided by the patient and passed from one or more of the home base station 1004, the smart device 1005, and the connected personal assistant 1007 to the clinic's base station (not shown in FIG. 7 ). For example, if a patient who has had spinal fusion surgery expresses back pain when walking to the connected personal assistant 1007, a healthcare professional can issue a prescription for pain relief and have the connected personal assistant notify the patient by "speaking" a call to their preferred pharmacy with a prescription for Vicodin®. The prescription will be ready for pickup at 4:00 PM.

[0077] Although the clinic base station (not shown in FIG. 7) and the clinic configuration computing device (not shown in FIG. 7) are described as separate devices, the configuration is not so limited; rather, the functionality of the clinic configuration computing device and the clinic base station may be included in a single computing device or separate devices (as shown). In this manner, medical personnel are enabled in one embodiment to enter configuration information or markers directly into the clinic base station and view high resolution data (and synchronized marker information) from a display on the clinic base station.

[0078] 7, alternative embodiments are contemplated. For example, one or two of the home base station 1004, the smart device 1005, and the connected personal assistant 1007 may be omitted from the intelligent implant environment 1000. For example, each of the base station 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 one or two of the base station, the smart device, and the connected personal assistant. Furthermore, the smart device 1005 may be any suitable device other than a smartphone, such as a smart watch, a smart patch, or any IoT device, such as a coffee pot, that can temporarily collapse and act as an interface to the implantable device 1002. Furthermore, one or more of the base station 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. Additionally, one or more of the base station 1004, smart device 1005, and connected personal assistant 1007 may automatically order or reorder prescriptions or medical supplies in response to patient input or implantable prosthesis input (e.g., pain level, instability level) if a medical professional and insurance company have pre-approved such ordering or reordering, or alternatively, one or more of the base station, smart device, and connected personal assistant may be configured to request approval from a medical professional or insurance company to place the order or reorder. Additionally, one or more of the base station 1004, smart device 1005, and connected personal assistant 1007 may comprise a personal assistant such as Alexa® or Siri®.

[0079] Intelligent Implant System The present disclosure provides medical devices, including prostheses or medical devices, that can be implanted into a patient (implants), which can be utilized to monitor and report the status and / or activity of the medical device, including post-operative activity and the progress of the patient involved, as well as its characteristics. The present disclosure provides intelligent implants or implantable sensor assemblies that achieve the benefits of medical implants, e.g., the benefits provided by prostheses that replace or supplement a patient's natural function, while also achieving the benefits of monitoring and reporting that provide insight into the function and / or status of the patient receiving the device and / or implanted device. The medical device can be an implantable device, e.g., an in vivo implantable prosthesis that can be implanted into the body of a living host (also referred to as a patient) to improve or replace the function of the patient's body's biological structures.

[0080] The present disclosure provides an intelligent implant, e.g., an implantable medical device, having an implantable reporting processor (IRP), also referred to herein as a cartridge. When the intelligent implant is included in a component of an implant system, 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 assess the mobility and health of a patient in whom the system is implanted.

[0081] A non-limiting and non-exhaustive list of embodiments of intelligent implants includes spinal implant components coupled to sensors. Examples of spinal devices and implants include pedestal screws, spinal rods, spinal wires, spinal plates, interbody spacers, spinal cages, artificial discs, faceted implants, bone cement, and combinations thereof (e.g., one or more pedestal screws and spinal rods, one or more pedestal screws and spinal plates). Additionally, medical delivery devices for placement of spinal devices and implants, along with one or more sensors, may be intelligent medical devices according to the present disclosure. Examples of medical delivery devices for spinal implants include kyphoplasty balloons, catheters (including thermal catheters and bone tunnel catheters), bone cement injection devices, microdiscectomy tools, and other surgical tools.

[0082] In some embodiments, spinal devices and implants may be embodied with any type of interbody fusion device (posterior lateral interbody fusion (PLIF), transforaminal LIF (TLIF), anterior LIF (ALIF), or lateral LIF (LLIF)) at either a single level or multilevel fusion (i.e., L4-L5 single level vs. L1-L5 multilevel). These implants can be made of any biocompatible material, but are typically PEEK or titanium.

[0083] In some embodiments, the intelligent implant may include an implantable reporting processor (IRP) integrated into a spinal cage or an interbody spacer used during spinal fusion. The interbody spacer can be inserted along any point of the patient's spine. For example, the interbody spacer can be inserted to provide spinal fusion in the lumbar, thoracic, and / or cervical spine. The interbody spacer may be configured to take load from adjacent vertebrae and may include an opening that can receive an IRP. In embodiments where an interbody spacer and a separate IRP cartridge are used, the physician couples the IRP with the interbody spacer to form the intelligent implant. As described elsewhere herein, in an alternative configuration, the IRP may be integrated into the implant and may contain any of the cartridge IRP features described herein. The physician can then fill the interbody spacer with material to retain the IRP and provide enhanced fusion between adjacent vertebrae. For example, the interbody spacer may be filled with bodily material (e.g., blood debris), other biological material, or other synthetic materials. As discussed in more detail below, the IRP can form a cartridge that can be permanently or reversibly inserted into the interbody spacer. The cartridge can include an antenna, an inertial measurement unit (IMU), and / or additional sensors capable of sensing and tracking patient movement.

[0084] FIG. 1A shows a perspective view of an intelligent implant 100 in the form of an interbody spacer including an implantable reporting processor 150. The implantable reporting processor 150 can interface with a spinal cage / interbody spacer such as that shown in FIG. 1A. For example, the components can be assembled intraoperatively. Interbody spacers can be provided in a variety of different shapes and sizes. As shown, the interbody spacer can include a top surface 102, a bottom surface 104, an inner surface 106, and an outer surface 108. The inner surface 106 can include an opening 110 and / or the outer surface 108 can include an opening 112. The openings 110 and / or the openings 112 can allow the implantable reporting processor 150 to be inserted and secured within the interbody spacer of the intelligent implant 100.

[0085] The implantable reporting processor 150 may include a housing 180 that encloses a battery, an electronics assembly, an antenna, and / or one or more sensors. The one or more sensors may include any of the sensors described herein. The housing 180 may include a cover or casing that encases and secures various components of the implantable reporting processor 150. For example, as shown in FIG. 1A , the implantable reporting processor 150 is in the form of a cartridge for insertion into a patient. The cartridge may be of any shape or size that allows it to be inserted into an interbody spacer. For example, the implantable reporting processor 150 of FIG. 1A is thin and wafer-shaped to allow it to be inserted through the opening 110 or 112 of the interbody spacer. The implantable reporting processor 150 may be generally D-shaped with a generally curved medial end 156 b and a generally straight lateral end 158 b. However, the implantable reporting processor 150 may also be cylindrical or any other shape or size. As shown in FIGS. 1B and 1C , the implantable reporting processor 150 may include a housing 180 that covers and encloses the battery and electronics assembly. In some embodiments, the implantable reporting processor 150 may include a top surface 152, a bottom surface 154, an inner surface 156 a, and a side surface 158 a. In some embodiments, the antenna 160 of the implantable reporting processor 150 may have a radome extending from the outer contour of the implantable reporting processor 150, for example, from the inner end 156 b of the implantable reporting processor 150. When assembled with a spinal cage / interbody spacer, the radome may protrude from the outer contour of the spacer. This arrangement enables communication even when the implantable reporting processor 150 and / or the spacer are made of metal. As described in more detail herein, the implantable reporting processor 150 and / or the spinal cage / interbody spacer may communicate with an external device, for example, using Bluetooth Low Energy, to transmit collected data or receive programming and configuration data. The antenna 160 may be optimized for frequencies in the range of 2.4 to 2.5 GHz.

[0086] As discussed in more detail below, the implantable reporting processor 150 may include one or more sensors positioned on various surfaces of the implantable reporting processor 150. As shown in FIGS. 1A-1C, the implantable reporting processor 150 may include at least one sensor 170. The at least one sensor 170 may be hermetically sealed and attached to or mounted within a surface of the implantable reporting processor 150, such as on the top surface 152 of the implantable reporting processor 150. As shown in FIGS. 1A-1C, the at least one sensor 170 of the implantable reporting processor 150 may include sensor 170a, sensor 170b, and sensor 170c. The sensors 170a, 170b, and 170c may be positioned in series.

[0087] At least one sensor 170 may include a strain or force sensor for detecting strain or force on the surface of the implantable reporting processor 150 as a means of detecting fusion between two adjacent vertebrae in which the spacer is positioned, as loads increase as fusion progresses.

[0088] At least one sensor 170 may include a vibration sensor that detects acoustic emissions associated with scraping / grinding of the interbody spacer against the adjacent vertebrae. As interbody fusion progresses, the degree of acoustic emissions changes (most likely decreases).

[0089] The vibration sensor can be combined with an accelerometer to collect acoustic emission (vibration) measurements while the patient is engaged in a known activity, such as walking. The accelerometer can be a low-power AC or DC accelerometer. The accelerometer can be hermetically sealed within the implantable reporting processor 150. The accelerometer can measure the tilt angle of the spine relative to the gravity vector, which provides a center of gravity measurement that correlates with the patient's recovery, pain level, and / or health status. The accelerometer can measure the patient's activity pattern (e.g., walking) and trigger the collection of data by the accelerometer that occurs during the target activity, such as walking.

[0090] Although the at least one sensor 170 is illustrated 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.

[0091] 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 Figures 1A-1C, the at least one sensor 172 of the implantable reporting processor 150 may include sensor 172a, sensor 172b, and sensor 172c. The sensors 172a, 172b, and 172c may be positioned in series.

[0092] In some configurations, the implantable report processor 150 may include at least one sensor 174 on the inner surface 156a of the implantable report processor 150. As shown in FIGS. 1A-1C, the at least one sensor 174 of the implantable report processor 150 includes sensor 174a and sensor 174b. However, the at least one sensor 174 may include more or fewer sensors in various configurations. In some configurations, the implantable report processor 150 may include at least one sensor 176 on the side surface 158a of the implantable report processor 150. As shown in FIGS. 1A-1C, the at least one sensor 176 of the implantable report processor 150 may include sensor 176a and sensor 176b. However, the at least one sensor 176 may include more or fewer sensors in various configurations. In some embodiments, the at least one sensor 170, the at least one sensor 172, the at least one sensor 174, and the at least one sensor 176 may be embedded within the material of the housing 180.

[0093] The implantable reporting processor 150 can be in the form of a cartridge that can be inserted into the interbody spacer through either the opening 110 in the inner surface 106 or the opening 112 in the outer surface 108. In some embodiments, the implantable reporting processor 150 can form a positive connection with the interbody spacer before the spine cage is inserted into the patient. For example, the positive connection can be any of several mechanical connections, such as a snap fit, locking, twisting, or mating threads. In some embodiments, the implantable reporting processor 150 can be reversibly inserted into the interbody spacer. The reversible connection between the implantable reporting processor 150 and the interbody spacer can provide a physician with the option to remove the cartridge once it has been inserted into the patient in situations where any maintenance may need to be performed on the implantable reporting processor 150. The reversible connection can allow the implantable reporting processor 150 to be removed in cases where a battery may need to be replaced.

[0094] 2A illustrates an intelligent implant 100 including an implantable reporting processor 250 for insertion into an interbody spacer of the intelligent implant 100. The implantable reporting processor 250 may include any of the features described above with respect to the implantable reporting processor 150. FIG. 2A illustrates an implantable reporting processor 250 for insertion into an interbody spacer that includes an antenna 260 that does not extend from a surface of the implantable reporting processor 250.

[0095] Similar to the implantable reporting processor 150, the implantable reporting processor 250 may include a housing 280 that encloses the battery 290, the electronics assembly 240, the antenna 260, and the plurality of sensors. Similar to the implantable reporting processor 150, the housing 280 of the implantable reporting processor 250 comprises a cover or casing that encases and secures the various components of the implantable reporting processor 250. For example, as shown in FIG. 2A , the implantable reporting processor 250 is in the form of a cartridge for insertion into a patient. The implantable reporting processor 250 may be of any shape or size that allows it to be inserted into the intelligent implant 100. For example, the implantable reporting processor 250 of FIGS. 2A-2C is thin and wafer-shaped to allow it to be inserted through the opening 110 or 112 of the interbody spacer. However, as described above with respect to the implantable reporting processor 150, the implantable reporting processor 250 may be cylindrical or any other shape or size. 2A-2C, the implantable reporting processor 250 may include a top surface 252, a bottom surface 254, an inner surface 256a, and an outer surface 258a. The implantable reporting processor 250 may include a housing 280 that covers and encloses the antenna 260 and electronics assembly 240 at the inner end 256b of the implantable reporting processor 250, and a battery 290 at the lateral end 258b.

[0096] Similar to the implantable reporting processor 150, the implantable reporting processor 250 may include multiple sensors (e.g., ultrasound sensors) positioned on various surfaces of the implantable reporting processor 250. As shown in Figures 2A-2D, the implantable reporting processor 250 may include at least one sensor 270 on the top surface 252 of the implantable reporting processor 250. As shown in Figures 2A-2C, the at least one sensor 270 of the implantable reporting processor 250 is composed of sensor 270a, sensor 270b, and sensor 270c. The sensors 270a, 270b, and 270c may be positioned in series along the top surface 252 of the implantable reporting processor 250.

[0097] Additionally or alternatively, the implantable reporting processor 250 may include at least one sensor 272 on the bottom surface 254 of the implantable reporting processor 250. As shown in Figures 2A-2C, the at least one sensor 272 may include sensor 272a, sensor 272b, and sensor 272c. The sensors 272a, 272b, and 272c may be positioned in series along the bottom surface 254 of the implantable reporting processor 250.

[0098] In some configurations, the implantable report processor 250 may include at least one sensor 274 on the inner surface 256a of the implantable report processor 250. As shown in FIGS. 2A-2C, the at least one sensor 274 of the implantable report processor 250 is composed of sensor 274a and sensor 274b. However, the at least one sensor 274 may include more or fewer sensors in any number of configurations. In some configurations, the implantable report processor 250 may include at least one sensor 276 on the lateral surface 258a of the implantable report processor 250. As shown in FIGS. 2A-2C, the at least one sensor 276 of the implantable report processor 250 may include sensor 276a and sensor 276b. However, the at least one sensor 276 may include more or fewer sensors in various configurations. In some embodiments, the at least one sensor 270, the at least one sensor 272, the at least one sensor 274, and the at least one sensor 276 may be embedded within the material of the housing 280.

[0099] FIG. 3 illustrates an intelligent implant 200 comprising an interbody spacer. The intelligent implant 200 may include any of the features described above with respect to the intelligent implant 100. The intelligent implant 200 may include a top surface 202, a bottom surface 204, an inner surface 206, and a side surface 208. The intelligent implant 200 includes an opening 210 for a window 220 and an opening 212 for the side surface 208. The intelligent implant 200 further includes a window 220 positioned at either the inner or outer end of the intelligent implant 200. In embodiments in which the implantable reporting processor includes an antenna that does not extend from the intelligent implant 200, the window 220 can allow signals to be transmitted from the intelligent implant 200 without any interference. This is particularly the case when the housing 280 of the implantable reporting processor 250 includes a material such as metal. In embodiments in which the housing 280 includes a material such as PEEK, signal transmission is not blocked, and therefore, a windowless intelligent implant 100 can be used.

[0100] 4A and 4B show cross-sectional medial-side views of intelligent implant 100 with either implantable reporting processor 150 or implantable reporting processor 250 inserted into an interbody spacer. FIG. 4A shows a cross-sectional view in which antenna 160 extends from opening 110 in medial surface 106. FIG. 4B shows a cross-sectional view in which implantable reporting processor 250 does not extend entirely from both ends of intelligent implant 100, but is contained entirely between medial surface 106 and outer surface 108 of intelligent implant 100.

[0101] 5A and 5B show proximal-front views of either implantable reporting processor 150 or implantable reporting processor 250 inserted into intelligent implant 100 or intelligent implant 200. In FIG. 5B, window 220 in implantable reporting processor 250 allows the top and / or bottom of antenna 260 on inner end 256b of implantable reporting processor 250 to be exposed. This is where antenna 260 is positioned below housing 280 so that antenna 260 can transmit signals from intelligent implant 200.

[0102] 16A-16I illustrate another embodiment of intelligent implant 300, where intelligent implant 300 is an interbody spacer 301. In some embodiments, interbody spacer 301 of FIGS. 16A-16I is a PLIF implant. Intelligent implant 300 may include an implantable reporting processor 350 for insertion into interbody spacer 300. Implantable reporting processor 350 may include any of the features described above with respect to implantable processors 150, 250. Implantable reporting processor 350 may be inserted into interbody spacer 301, as shown in FIGS. 16H-16I.

[0103] 16A and 16B , interbody spacer 301 can include left surface 302, right surface 304, first end 306, second end 308, bottom surface 305, and top surface 303. In some embodiments, depending on how interbody spacer 301 is inserted into the body, bottom surface 305 can form the underside of interbody spacer 301 and top surface 303 can form the top side of interbody spacer 301, or bottom surface 305 can form the underside of interbody spacer 301 and bottom surface 305 can form the top side of interbody spacer 301. First end 306 can include an opening 310 that allows for insertion of an implantable reporting processor 350 into interbody spacer 301. As shown in the cross-sectional views of FIGS. 16H-16I, interbody spacer 301 may include a cavity 312 extending internally through body 301 from opening 310 at a first end of body 301 to a second end of body 301. Opening 310 and cavity 312 may allow for insertion and fixation of implantable reporting processor 350 within interbody spacer 300. In some embodiments, interbody spacer 301 may be made of PEEK. Interbody spacer 301 may also include tooling hole 330 on first end 306 of interbody spacer 301. Interbody spacer 301 may also include multiple tooling notches 340a, 340b at first end 306 of interbody spacer 301. Tooling hole 330 and notches 340a, 340b allow a physician to insert interbody spacer 301 into a patient's spine.

[0104] In other embodiments, interbody spacer 301 may be made of titanium. Intelligent implant 300 may be configured to be inserted at any location in the spine. For example, intelligent implant 300 may include any of a lumbar interbody spacer, a cervical interbody spacer, or a thoracic interbody spacer.

[0105] In some embodiments, interbody spacer 301 may include a plurality of notches and openings that allow a physician to fill the interbody spacer with material to better retain intelligent implant 300 and provide enhanced fusion between adjacent vertebrae. For example, interbody spacer 301 may be filled with bodily material (e.g., blood debris), other biological material, or synthetic materials. As shown in FIGS. 16A-16H, interbody spacer 301 may include opening 350 that forms a through-hole extending from the anterior side of interbody spacer 301 to the posterior side of the interbody spacer. As described above, the opening may be filled with biological or synthetic material to assist in fusion of adjacent vertebrae.

[0106] Interbody spacer 301 may include ridged or grooved surfaces that provide scoring to enable better fixation of intelligent implant 300 between vertebrae within the body. As shown in FIGS. 16A and 16B , top surface 303 includes multiple or alternating ridges 303 a and grooves 303 b. Similarly, bottom surface 305 may also include multiple alternating ridges 305 a and grooves 305 b. The angled scoring formed on top surface 303 and bottom surface 305 increases the surface area of ​​interbody spacer 301 that engages with adjacent vertebrae, providing better fixation of intelligent implant 300 within the body.

[0107] The implantable reporting processor 350 may include a housing 380 that encloses multiple elements for measuring the patient's kinematics and powering the intelligent implant 300. For example, the housing 380 may enclose a battery, an electronics assembly, an antenna, and one or more sensors. The one or more sensors may include any of the sensors described herein. The housing 380 may include a cover or casing that encases and secures the various components of the implantable reporting processor 350. As shown in FIG. 16I, the implantable reporting processor 350 may be in the form of a cartridge for insertion into the intelligent implant 300. The cartridge may be of any shape or size that allows it to be inserted into the interbody spacer 301. In the currently illustrated embodiment, the implantable reporting processor 350 is shaped to fit within the opening 310 and cavity 312 of the interbody spacer 301. In some examples, the implantable reporting processor 350 may 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 reporting processor 350 may be sized so that it can be received within the cavity 312 of the interbody spacer 301. The first portion 352 of the implantable reporting processor 350 may be sized so that it can be received within the opening 310 but does not extend into the cavity 312. This may allow the implantable reporting processor 350 to be secured and properly positioned within the body of the interbody spacer 301.

[0108] The implantable reporting processor 350 can be in the form of a cartridge that can be inserted into the interbody spacer 301 through the opening 310 in the first end 306. In some embodiments, the implantable reporting processor 350 can form a positive connection with the interbody spacer 301 before the interbody spacer 301 is inserted into the patient. For example, the implantable reporting processor 350 has a locking mechanism (e.g., tabs) that can lock with the interbody spacer 301. The positive connection can be any of several mechanical connections, such as a snap fit, lock, twist, or mating threads. In some embodiments, the implantable reporting processor 150 can be reversibly inserted into the interbody spacer. The reversible connection between the implantable reporting processor 150 and the interbody spacer can provide a physician with the option to remove the cartridge once it has been inserted into the patient in situations where any maintenance may need to be performed on the implantable reporting processor 150. The reversible connection can allow the implantable reporting processor 150 to be removed in cases where a battery may need to be replaced. In other embodiments, the locking mechanism is not reversible. The implantable reporting processor may include screws that allow the implantable reporting processor 350 to be assembled with the interbody spacer 301 before the intelligent implant 300 is implanted.

[0109] In some embodiments, the implantable reporting processor 350 may be configured to communicate with an external device. Communication may occur, for example, using Bluetooth Low Energy to transmit collected data or receive programming and configuration data. In some embodiments, the implantable reporting processor may include an antenna that may be optimized for frequencies in the 2.4-2.6 GHz range.

[0110] As discussed in more detail below, the implantable reporting processor 350 may include one or more sensors positioned on various surfaces of the implantable reporting processor 350. In some embodiments, at least one sensor may be hermetically sealed and mounted within or mounted to a surface of the implantable reporting processor, such as, for example, on the top surface of the implantable reporting processor 350.

[0111] In some embodiments, the implantable reporting processor 350 may include a strain or force sensor for detecting strain or force on the surface of the implantable reporting processor 350 as a method of detecting fusion between adjacent vertebrae in which the interbody spacer is positioned, as loads increase as fusion progresses.

[0112] In some embodiments, the at least one sensor of the implantable reporting processor 350 may include a vibration sensor that detects acoustic emissions associated with scraping / grinding of the interbody spacer 301 against adjacent vertebrae. As intervertebral fusion progresses, the degree of acoustic emissions may change (most likely decreasing). In some embodiments, the vibration sensor may be combined with at least one accelerometer to collect acoustic emission / vibration measurements while the patient is engaged in a known activity, such as walking. The accelerometer may be a low-power AC or DC accelerometer. The at least one accelerometer may be hermetically sealed within the implantable reporting processor 350. In some embodiments, the at least one accelerometer may measure the tilt angle of the spine relative to a gravity vector, which provides a center of gravity measurement that correlates with the patient's recovery, pain level, and / or health status. The at least one accelerometer may measure the patient's activity pattern (e.g., walking) and trigger data collection by the at least one accelerometer that occurs during a target activity, such as walking.

[0113] As described above, an implantable reporting processor in the form of a cartridge can be inserted into an intelligent implant. The cartridge can be inserted into the interbody spacer of the intelligent implant so that it does not extend beyond the perimeter of the interbody spacer's geometric shape. This prevents cartridge interference with surrounding soft tissue and neural tissue (i.e., the spinal cord). This can be seen in Figures 16A-16I, which show an implantable reporting processor cartridge 350 inserted into a PLIF interbody spacer 301. As shown in the cross-sectional view of Figure 16H, a first portion of the cartridge 350 can be placed flush with the perimeter of the PLIF interbody spacer 301. In another embodiment, shown in Figure 17, an implantable reporting processor cartridge 450 is inserted into a LLIF interbody spacer 401. As shown, the medial end 452 of the cartridge 450 is not flush with the perimeter of the LLIF interbody spacer 401, but extends within it.

[0114] In some embodiments, the cartridge 350, 450 can have an outer wall configured to provide break / yield strength to sustain expected loads on the interbody spacer 301, 401. The outer wall of the cartridge 350, 450 can have a minimum wall thickness of 0.5 mm. In some examples, the wall thickness of the cartridge 350, 450 can be less than 1 mm. In some embodiments, the wall thickness can 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, or about 1.2 mm. In some examples, the wall thickness can range from about 0.4 mm to 0.6 mm, about 0.45 mm to 0.55 mm, about 0.9 mm to 1.10 mm, about 0.95 mm to 1.05 mm, about 0.5 mm to 0.6 mm, about 0.6 mm to 0.7 mm, about 0.7 mm to 0.8 mm, about 0.8 mm to 0.9 mm, about 0.9 mm to 1.0 mm, and any value between the recited ranges, inclusive.

[0115] FIG. 18 illustrates an embodiment of a cartridge 500. In some embodiments, the cartridge 550 can be rectangular, although the cartridge can be any shape (e.g., cylindrical). The cartridge 550 can have a width-to-height aspect ratio of 1:2, which can provide optimized mechanical strength for handling compressive strength. In some embodiments, the cartridge 550 can have a width-to-height aspect ratio of 2:3, which can also provide mechanical strength. In some embodiments, the cartridge 550 can 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 to 5:12, about 5:12 to 6:12, about 6:12 to 7:12, about 7:12 to 8:12, about 8:12 to 9:12, about 9:12 to 10:12, and any aspect ratio between the recited ranges, inclusive. In some embodiments, the width to height aspect ratio can provide mechanical strength to handle compressive shear and torsional forces.

[0116] 18, in some embodiments, cartridge 500 may include a power source such as a battery 552, electronics 554, and antenna 556. In some embodiments, cartridge 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 cartridge 550 without the antenna is approximately 20 mm.

[0117] The implantable reporting processor in the form of a cartridge is insertable into the intelligent implant. This feature allows the implantable reporting processor cartridge to be used in a variety of applications and with a variety of implant sizes. In some embodiments, the intelligent implant may include a locking structure to retain the implantable reporting processor cartridge within the interbody spacer to prevent it from becoming dislodged or loose once the intelligent implant is inserted into a patient's body.

[0118] In addition to the embodiments discussed regarding cartridge fixation, FIGS. 19A, 19B, and 19C illustrate various examples of mechanical locking structures. FIG. 19A illustrates a locking mechanism 600a including an interbody locking finger 610a. The interbody locking finger 610a of the locking mechanism 600a can be a passive locking spring finger formed on the interbody spacer when the cartridge 550 is inserted. In some embodiments, the cartridge design can include a mechanical ramp and ledge so that the interbody locking finger 610a deforms outward as the cartridge 550 is inserted until the cartridge 550 is fully inserted and the interbody locking finger 610a returns to its predetermined position. In some embodiments, the locking mechanism 600a can form a minimum of 0.5 mm to 1 mm of mechanical interference that can retain the cartridge 550 after insertion. In some examples, the interbody locking finger 610a can be additively manufactured as a feature included within the interbody spacer.

[0119] FIG. 19B illustrates a locking mechanism 600b that can include a locking pin 610b and a cartridge locking ledge 612b. In some embodiments, the locking mechanism 600b forms a passive locking ledge design on the cartridge 550. The locking mechanism 600b is configured to retain the cartridge 550 within the interbody spacer via the locking pin 610b on the interbody spacer. In some embodiments, the cartridge's locking pin 610b can have a minimum mechanical interference of 0.5 mm to 1.0 mm to retain the cartridge 550 after insertion into the interbody spacer. In some embodiments, the cartridge's locking ledge 612b can have the radius of the locking pin 610b. In some examples, the locking pin 610b can be an inserted pin / rod or a 3D printed feature contained within the interbody spacer.

[0120] 19C illustrates a locking mechanism 600c positioned on the body of cartridge 550. As shown, locking mechanism 600c can include a locking clip 610c and a groove 620c. Locking clip 610c is configured to reduce its profile when compressed and expand its profile when decompressed. In some embodiments, the interbody spacer can include a groove (not shown). Locking clip 610c on cartridge 550 can compress when it is inserted into the interbody spacer, but then expand / contract when cartridge 550 is inserted, positioning locking clip 610c within the groove of the interbody spacer.

[0121] In some embodiments, after the cartridge is assembled into the interbody spacer, the antenna can be configured to wirelessly communicate with an external source to transmit data. In some embodiments, the cartridge is fully contained within the interbody spacer, while the antenna has an uninterrupted line of sight by the interbody spacer. FIGS. 20A and 20B illustrate an embodiment of a cartridge 550 positioned within an interbody spacer 301, 401. As shown, each cartridge 550 includes an antenna 556 positioned within the outer housing of the cartridge and within an opening in the interbody spacer so that the antenna 556 can transmit signals uninterrupted. This can provide optimal radio frequency efficiency, field strength, and radiation. In some embodiments, the antenna 556 is positioned as far away from the titanium material as possible while maintaining the cartridge 556 fully contained within the periphery of the interbody spacer 301, 401. In some embodiments, the cartridge may have a 0.2 mm gap around the cartridge 550 within the interbody spacer 301, 401.

[0122] 6 shows a posterior front view of the intelligent implants 100, 200 inserted into a patient's spine 10 during a spinal fusion procedure. As mentioned above, the intelligent implants 100, 200 are in the form of interbody spacers and are inserted between adjacent vertebrae 20. The adjacent vertebrae 20 may include a number of seating screws 30 and rods 40 that help secure the vertebrae 20 in place during and after the spinal fusion.

[0123] Portable Report Processor (IRP) The present disclosure provides an implantable reporting processor (IRP) or cartridge for an implant system for use in a spinal procedure. As previously described, the IRP can be a component assembly manufactured separately from other components of the implant system and then 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 their manufacture. When integrated, the IRP can still include any of the features of a separate cartridge described herein. In some embodiments, the present disclosure provides a reporting processor intended to be implanted with a medical device, e.g., a prosthesis, where the reporting processor monitors the status of the device after implantation by acquiring kinematic data, typically in the range of about 10-120 Hz.

[0124] As discussed herein, the device status may include device integrity, device movement, forces exerted on the device, and other information related to the implanted device. The present disclosure also provides medical devices with a structure that allows them to easily mate with an IRP. An implantable medical device with an IRP is referred to herein as an intelligent implant, in recognition that the implant monitors its own condition or status, thereby acquiring data that is stored in the implant and then, if desired, transmitted to a separate device for review, for example, by a physician.

[0125] For example, an intelligent implant of the present disclosure with appropriate internal electronic components may be utilized to monitor and measure post-operative surgical patient motion and kinematics (e.g., activity, gait, steps, posture, hip range of motion, etc.) after implantation of an interbody spacer or cage during spinal fusion, as needed, store the measurement data and unique identification information of the prosthetic components, and transmit the data to an external recipient (e.g., a physician, clinician, or medical assistant). The IRP may include one or more sensors, such as a gyroscope, accelerometer, and temperature and pressure sensors, which may be located anywhere within the IRP outer casing; for example, they may all be located on a PC board. In some embodiments, the IRP performs kinematic measurements, for example, when the intelligent implant is secured within the interbody spacer or cage; in other embodiments, the IRP performs only kinematic measurements. Thus, the intelligent implant may include sensors for kinematic measurements to determine the motion experienced by the implanted prosthesis.

[0126] The IRP and medical device are each intended to be implanted into a living subject, such as a mammal, e.g., a human, horse, dog, etc. Accordingly, in some embodiments, the IRP is sterilized, e.g., treated with sterilizing radiation or treated with ethylene oxide. In some examples, an intelligent implant including the IRP and medical device is again sterilized by treatment with sterilizing radiation or ethylene oxide, as two examples. To protect from the in vivo environment, in some embodiments, the IRP is hermetically sealed so that fluids cannot enter the IRP.

[0127] In some embodiments, implantable devices need to be robust and small, or space-efficient, due to the limited space available within the body and / or artificial implants for placement of such devices. Challenges to the commercial success of implantable devices with internal electronic components and either internal or external transmitting antennas are that the device and / or transmitting antenna should not be unduly large, their power consumption should allow them to operate adequately for an adequately long period of time, i.e., not a limited period of time, and they should not be adversely affected by the local biological environment. The IRPs of the present disclosure may have suitable internal or external space- and / or power-efficient antennas.

[0128] An IRP typically includes an outer casing that encloses multiple components. Exemplary suitable IRP components include a signal portal, an electronics assembly, and / or a power supply. The signal portal functions to receive and transmit wireless signals and may include, for example, an antenna for transmitting wireless signals. The electronics assembly includes a circuit assembly that may include a PC board and electrical components formed on one or more integrated circuits (ICs) or chips, such as, for example, a wireless transmitter chip, a real-time clock chip, one or more sensor components, such as, for example, an inertial measurement unit (IMU) chip, a temperature sensor, a pressure sensor, a tilt sensor, a strain sensor, a pedometer, and a memory chip. Additionally, the electronics assembly may include a header assembly that provides a communication interface between the circuit assembly and the signal portal (e.g., the antenna). The power supply provides the energy necessary to operate the IRP and may be, for example, a battery. The IRP also includes one or more sensors, such as a gyroscope, an accelerometer, a pedometer, a tilt sensor, a strain sensor, and temperature and pressure sensors, which may be located anywhere within the IRP outer casing, for example, they may all be located on the PC board. More precisely, embodiments of the present disclosure are directed to a space-efficient printed circuit assembly (PCA) for an implantable reporting processor (IRP). The implantable reporting processor may also include multiple transmit antennas structured in different configurations. Thus, embodiments of the present disclosure are directed to multiple enhanced space- and power-efficient antenna configurations for implantable reporting processors, such as IRPs.

[0129] An example of an implantable reporting processor includes an outer casing or housing sized to fit into or form part of an implantable prosthesis having at least a portion designed to fit into the bones of a living patient. Electronic circuitry is disposed within the housing and configured to provide information related to the prosthesis to a destination outside the patient's body. A battery is disposed within the casing and coupled to the electronic circuitry.

[0130] 8 and 9 show block diagrams of an IRP that may be associated with an intelligent implant. Components include an electronics assembly 1010 having a battery 1012, an RF antenna 1030, and various circuits powered by a power source. Depending on the design, the circuitry of the electronics assembly 1010 may include a fuse 1014, 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, and communication components, such as a radio frequency (RF) transceiver 1026 and an RF filter 1028, that couple with the RF antenna 1030 and / or controller 1032. Although not shown, a tilt sensor is optionally present. Also, although not shown, a strain sensor is optionally present.

[0131] Measurement Unit overview In some embodiments, the measurement unit can monitor one or more aspects of the implant. One or more measurement units 1022 may be configured to detect, measure, and / or monitor information related to the status of the device after implantation. The status of the device may include device integrity, device movement, forces exerted on the device, and other information related to the implanted device. This type of measurement unit 1022 may include a processor located on the printed circuit board of the electronics assembly 1010 and one or more sensors coupled to the processor, such as a gyroscope, accelerometer, tilt sensor, strain sensor, and temperature and pressure sensors. These sensors may also be located on the printed circuit board of the electronics assembly 1010. Alternatively, some or all of these sensors, e.g., tilt sensor, strain sensor, gyroscope, accelerometer, may be located in or on another structure of the intelligent implant separate from the electronics assembly 1010.

[0132] In some embodiments, the measurement unit can monitor one or more aspects of the status or function of the body or body segment / joint (e.g., healing, movement including measuring the position, angle, velocity, and acceleration of the body segment and joint). One or more measurement units 1022 may be configured to detect, measure, and / or monitor information related to the status of the body or body segment after implantation of the device. The status of the body or body segment may include, for example, kinematic information of the body or body segment, healing information. This type of measurement unit 1022 may include a processor located on the printed circuit board of the electronics assembly 1010 and one or more sensors coupled to the processor, such as gyroscopes, accelerometers, tilt sensors, strain sensors, electrodes, and temperature and pressure sensors. These sensors may also be located on the printed circuit board of the electronics assembly 1010. Alternatively, some or all of these sensors may be located in or on another structure of the intelligent implant device separate from the electronics assembly 1010.

[0133] In some embodiments, the device can monitor body tissue (e.g., anatomy, physiology, metabolism, and / or function). The measurement unit 1022 can be configured to detect, measure, and / or monitor body tissue related information after 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 located on the printed circuit board of the electronics assembly 1010 and one or more sensors, 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), etc. These sensors can also be located on the printed circuit board of the electronics assembly 1010. Alternatively, some or all of these sensors can be located within or on the structure of the intelligent implant device separate from the electronics assembly 1010.

[0134] The measurement unit may perform one or more of any of the above mentioned intelligent functions.

[0135] Inertial Measurement Unit In some embodiments, the measurement unit 1022 is an inertial measurement unit (IMU). For example, the IMU may be a Bosch BMI 160 small, low-power IMU. As shown in FIG. 10 , the measurement unit 1022 includes three measurement axes 1060, 1062, and 1064, which for purposes of explanation are arbitrarily labeled x, y, and z. That is, in a Cartesian coordinate system, the labels “x,” “y,” and “z” may be arbitrarily applied to the axes 1060, 1062, and 1064 in any order or arrangement. Marks 1066 are references indicating the location and orientation of the axes 1060, 1062, and 1064 relative to the IMU package. The IMU may include one or more accelerometers, for example, three accelerometers, each of which senses and measures linear acceleration a(t) along a respective one of axes 1060 (x), 1062 (y), and 1064 (z), where 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 respective analog sense or output signal having an instantaneous magnitude that represents the instantaneous magnitude of the sensed acceleration along the corresponding axis. For example, the magnitude of the accelerometer output signal at a given time is proportional to the magnitude of the acceleration along that accelerometer's sensitive axis at the same time.

[0136] The IMU can include one or more gyroscopes, e.g., three gyroscopes, each of which senses and measures angular velocity Ω(t) about a respective one of axes 1060 (x), 1062 (y), and 1064 (z), where Ω(t) is the angular velocity along the x-axis, Ω(t) is the angular velocity along the y-axis, and Ω(t) is the angular velocity along the z-axis. Each gyroscope generates a respective analog sense or output signal having an instantaneous magnitude that represents the instantaneous magnitude of the sensed angular velocity about the corresponding axis. For example, the magnitude of the gyroscope output signal at a given time is proportional to the magnitude of the angular velocity about the gyroscope's sensing axis at the same time.

[0137] The IMU may have one or more analog-to-digital converters (ADCs) for each axis 1060, 1062, and 1064, e.g., 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 rate signal. For example, each of the ADCs may be an 8-bit, 16-bit, or 24-bit ADC.

[0138] Each ADC can 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 that have configurable values ​​include the sampling rate, the dynamic range at the ADC input node, and the output data rate (ODR). One or more of these parameters may be set to a fixed value, while one or more of these parameters may be dynamically configurable (e.g., during run time). For example, the respective sampling rate of each ADC may be dynamically configurable such that during one sampling period the sampling rate has one value and during another sampling period the sampling rate has another value.

[0139] For each digital acceleration signal and each digital angular rate signal, the IMU may be configured to provide parameter values ​​associated with the signal. For example, the IMU may provide, for each digital acceleration signal and each digital angular rate signal, a sampling rate, a dynamic range, and a timestamp indicating when the first or last sample was taken. The IMU 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.

[0140] Ultrasound In some embodiments, the IRP may include one or more ultrasound sensors, which, as discussed in more detail below, provide direct measurement of spinal subsidence and intelligent implant movement following spinal fusion.

[0141] Ultrasound sensors can be useful because they can measure using sound waves that are not affected by material or tissue overgrowth. In some embodiments, the ultrasound sensors can be positioned on the surface of the intelligent implant, as shown in Figures 1A-1C, 2A, and 2B.

[0142] The ultrasound sensors used can be either M-mode or B-mode ultrasound sensors. In some embodiments, the ultrasound sensors are B-mode ultrasound sensors configured to measure distance. As discussed in more detail below, ultrasound sensors positioned around the implantable reporting processor can provide direct measurements of various states of spinal fusion. 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 direct measurements of interbody spacer or spinal cage movement. This can be useful because it can help determine whether adjacent vertebrae have fused. If the interbody spacer or spinal cage continues to move, this can be an indication to the physician that spinal fusion has not fully occurred.

[0143] As another example, sensors (e.g., at least one sensor 170, at least one sensor 172, at least one sensor 270, at least one sensor 272) positioned on the top and bottom surfaces of the implantable reporting processor can provide a direct measurement of 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 then as a function of time. As the distance between the top surface of the interbody spacer or spinal cage and a first vertebra and / or the distance between the bottom surface of the interbody spacer or spinal cage and a second vertebra changes over time, this can indicate to the physician anatomical changes due to loading and / or bone quality that may result in pain associated with spinal deformity.

[0144] In some embodiments, the ultrasonic sensor may be an ultra-low power ultrasonic sensor that can be driven in the microampere range.

[0145] fuse In some embodiments, fuse 1014 may be any suitable fuse (e.g., permanent) or circuit breaker (e.g., resettable) configured to prevent battery 1012, or current flowing from the battery, from harming the patient and / or damaging one or more components of the battery and electronics assembly 1010. For example, fuse 1014 may be configured to prevent battery 1012 from generating enough heat to burn the patient, damage electronics assembly 1010, damage the battery, or damage structural components of the implantable intelligent implant.

[0146] communication RF Telemetry RF transceiver 1026 may be a transceiver configured to enable controller 1032 (and optionally fuse 1014) to communicate with a base station (not shown in FIG. 8) configured for use with the intelligent implant. For example, RF transceiver 1026 may be any suitable type of transceiver (e.g., Bluetooth, Bluetooth Low Energy (BTLE), and WiFi), may be configured to operate according to any suitable protocol (e.g., MICS, ISM, Bluetooth, Bluetooth Low Energy (BTLE), and WiFi), and may be configured to operate in a frequency band within the range of 1 MHz to 5.4 GHz, or any other suitable range.

[0147] In some embodiments, the filter 1028 may be any suitable bandpass filter, such as a surface acoustic wave (SAW) filter or a bulk acoustic wave (BAW) filter.

[0148] Antennas - Overview The antenna 1030 may be any antenna suitable for the frequency band in which the RF transceiver 1026 generates signals for transmission by the antenna and in which the base station (not shown in FIG. 8 or FIG. 9) generates signals for reception by the antenna.

[0149] Loop antenna In some embodiments, the antenna 1030 may be a loop antenna. For example, the loop antenna may be a conductive loop formed of platinum-iridium (PtIr=90 / 10) ribbon with one end connected to the wireless transceiver and the other end connected to a 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 may be encapsulated by a cover and an epoxy backfill, both of which are non-conductive. The antenna may be the only electrically active component of the implantable reporting processor outside the sealed assembly, and under normal operating conditions, the epoxy backfill and PEEK cover insulate it from electrically interacting with surrounding tissue.

[0150] 11A-11E show several views of a loop antenna that can be configured for use with an IRP and an integrated IRP. The loop antenna can be designed to transmit information generated by the IRP's electronics assembly to a remote destination outside the subject's body in which the intelligent implant is implanted and to receive information from a remote source outside the subject's body. The loop antenna can be a flat ribbon 902 configured into a loop 904 having a curved end 906, a flat end 908 opposite the curved end, and a pair of opposing sides 910, 912 extending between the curved and flat ends. The flat ribbon 902 forming the loop antenna has a major surface 914 and a small edge 916. Due to skin effects on RF transmission, it may be desirable to maximize the cross-sectional area of ​​the antenna to minimize RF energy loss while also minimizing PtIr volume, thereby minimizing cost. The thickness of the flat ribbon 902 represents an approximate minimum for maintaining the antenna shape during assembly, and the height (h) of the flat ribbon is such that the required surface area is achieved.

[0151] 11A-11C, the flat end 908 of the antenna 1030 can be electrically coupled to the electronics assembly. To this end, the flat end 908 of the antenna 1030 comprises a first portion 918 separated by a gap from a second portion 920. The first portion 918 includes a first notch 922 on an edge configured to mate with a first feedthrough pin of the electronics assembly 1010. The second portion 920 includes a second notch 924 on an edge configured to mate with a second feedthrough pin (not shown) of the electronics assembly.

[0152] In some embodiments, with regard to the material and surface finish of the loop antenna 1030, the antenna is formed of a material including platinum (Pt) having an atomic percentage ranging from 70% to 100% and iridium (Ir) having an atomic percentage ranging from 0% to 30%. In one exemplary configuration, the antenna 1030 is formed of Pt90Ir10. The platinum alloy and Pt-Ir alloy are selected for their combination of biocompatibility, ductility, and electrical conductivity.

[0153] In some embodiments, the major surface 914 of the antenna 1030 has a surface finish ranging from 0 microinches up to 15 microinches. In one exemplary configuration, the surface finish is up to 6 microinches.

[0154] As described above, in the IRP configuration, the antenna 1030 is coupled to the electronics assembly through a dielectric feedthrough, with a dielectric PEEK cover and backfill encasing the antenna. The backfill may be silicone or a medical-grade epoxy adhesive. The incorporation of the antenna into the dielectric, combined with the antenna's post-implant placement in bone tissue and muscle, can affect the antenna's performance. However, the antenna 1030 disclosed herein, in combination with the electronics assembly's circuitry, geometry, orientation, material composition, surface finish, etc., enables post-implant communication at both 2.45 GHz and the Medical Implant Communication System (MICS) frequency band, e.g., 401-406 MHz, despite the presence of surrounding dielectrics and tissue.

[0155] In some embodiments, a loop antenna 1030 having the physical characteristics described above with reference to Figures 11A-11E is tuned to allow post-implant reception of an ultra-low power wake-up sniff signal on a 2.45 GHz channel, while also tuned to allow post-implant reception and transmission of data and information on a MICS channel, e.g., a 400 MHz channel.

[0156] Conformal Antenna In some embodiments, the antenna 1030 may be a conformal antenna. As shown in FIG. 12, a conformal antenna 1200 can be used with an IRP. The conformal antenna 1200 can include conductive traces positioned (printed, painted, or otherwise positioned) on a substrate 1202. 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 positioned on the substrate 1202 to facilitate adhesion of the conductive traces. Such a layer can be made of titanium. The substrate 1202 can be supported by a spacer 1206, which is supported by a base 1208. A feed 1203 can connect the conformal antenna 1200 to electronic circuitry (not shown), which can include transmit and receive circuitry. An antenna impedance matching circuit can connect the antenna feed 1203 and the transceiver. The conformal antenna 1200 may be referred to as a single-layer conformal antenna because the conductive traces are located on only one layer of the substrate 1202. In some implementations, as described herein, a conformal antenna may include conductive traces located on multiple layers (such as a top layer and a bottom layer) of the substrate 1202.

[0157] The conductive traces may be arranged in a set of outer traces 1210 and a set of inner traces 1212. The two sets of traces 1210 and 1212 may be connected at 1214. The set of inner traces 1212 may be connected to the feed 1203 at a feed point 1216 located at the center of the circle. The set of outer traces (or outer ring) 1210 may include multiple sections shaped as petals, which may be connected to one another. Similarly, the set of inner traces (or inner ring) 1212 may include multiple sections shaped as petals, which may be connected to one another. Shaping the traces as petals may result in a design in which the traces are symmetrically arranged around the feed point 1216, which has been found to improve the performance of the conformal antenna 1200. The spacing of the petals in one or more sets of traces 1210 or 1212 may affect the resonance of the conformal antenna 1200. For example, positioning the petals closer together may improve the resonance of the conformal antenna 1200 in one or more of the MICS or ISM bands. Adding more petals to one or more sets of traces 1210 or 1212 can increase the electrical length of the conformal antenna 1200 and improve resonance in one or more of the MICS or ISM bands. Rounding corners, such as the corners of a "V"-like shape, can affect the resonance of the conformal antenna 1200. While a petal-shaped section is illustrated in FIG. 12, other symmetrical (or asymmetrical) shapes can be used. For example, a zigzag pattern of traces can be used.

[0158] The conformal antenna 1200 may include a stub 1220, which may be a round trace connected to the set of inner traces 1212. As described herein, varying the length of the stub 1220 can improve the performance of the conformal antenna 1200.

[0159] Although conformal antenna 1200 is illustrated as a circular structure, the antenna may be non-circular in some implementations.

[0160] PIFA antenna In some embodiments, the antenna 1030 may be a PIFA antenna. FIG. 13 shows a PIFA antenna supported by a substrate 1043. The PIFA antenna may include a conductive trace 1041 positioned (printed, painted, or otherwise positioned) on the substrate 1043. The conductive trace 1041 may be made of a material (one or more of gold, silver, platinum, graphite, copper, etc.) that may be printed, painted, or otherwise positioned on the substrate 1043. The material may be biocompatible. In some cases, the material may be a conductive ink. The PIFA antenna may be a type of conformal antenna.

[0161] The substrate 1043 can be made of a non-conductive, biocompatible material, such as liquid crystal polymer (LCP), polyimide, or polyamide, onto which the conductive traces can be printed, painted, or otherwise positioned. The material can have long-term biocompatibility. The substrate 1043 can be supported by a spacer 1045 (or support) that can separate the traces 1041 from the housing 1049 of the sensor assembly. The spacer 1045 can be made of a non-conductive material (such as a thermoplastic material) and can act as a separator between the conductive material of the housing 1049 and the conductive antenna traces to improve antenna performance. As described herein, varying the height of the spacer 1045 can affect the characteristics of the antenna 1030. To increase the electrical length of the PIFA antenna 1030 (so that the antenna can resonate in one or more desired frequency bands), the antenna traces can be wrapped around the spacer 1045, as shown in FIG. 13 . The spacer 1045 can be supported by a base 1047. A feed (not shown) can connect the PIFA antenna 1030 to electronic circuitry (not shown), which may include transmit and receive circuitry. An antenna impedance matching circuit can connect the antenna feed and the transceiver. Although the PIFA antenna 1030 is shown as a circular structure, the antenna may be non-circular in some implementations.

[0162] Spiral Antenna In some embodiments, the antenna 1030 may be a helical antenna. Figure 14 illustrates an embodiment of a helical or spiral antenna.

[0163] Clock and Power Management Circuit 8 and 9, the clock and power management circuit 1020 may be configured to generate clock signals for one or more of the other components of the electronics assembly 1010, and may be configured to generate periodic commands or other signals (e.g., suspend requests) in response to the controller 1032 causing one or more components of the implantable circuit to enter or exit a sleep mode or other low-power mode. The clock and power management circuit 1020 may 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 electronics assembly 1010.

[0164] memory 8 and 9, memory 1024 may be any suitable non-volatile memory, such as EEPROM or FLASH memory, and may be configured to store data written by controller 1032 and to provide data in response to read commands from the control circuitry.

[0165] switch 8 and 9 , the switch 1016 may be configured to couple the battery 1012 to or decouple the battery from one or more measurement units 1022 in response to a control signal from the controller 1032. For example, the controller 1032 may be configured to generate a control signal having an open state that causes the switch 1016 to open, thus decoupling power from one or more measurement units 1022 during a sleep mode or other low-power mode, conserving power and therefore extending the life of the battery 1012. Similarly, the controller 1032 may also be configured to generate a control signal having a closed state that causes the switch 1016 to close, thus coupling power to one or more measurement units 1022 upon waking from a sleep mode or exiting another low-power mode. Such a low-power mode may be for only one or more measurement units 1022, or for the measurement units and one or more other components of the electronics assembly 1010.

[0166] The switch 1018 may 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 may be configured to generate a control signal having an open state that causes the switch 1018 to open, thus decoupling power from the memory 1024 during a sleep mode or other low-power mode to conserve power and therefore extend the life of the battery 1012. Similarly, the controller 1032 may also be configured to generate a control signal having a closed state that causes the switch 1018 to close, thus coupling power to the memory 1024 upon waking from a sleep mode or exiting another low-power mode. Such a low-power mode may be for only the memory 1024 or for the memory and one or more other components of the electronics assembly 1010.

[0167] power supply battery The intelligent implant optionally has a power source necessary to operate the electronics within the IRP that measure, record, and transmit data about the state of the implant. Some medical implants already have a power source. In some embodiments, this power source is in the form of a battery.

[0168] The power profile of the implantable reporting processor's electronic circuitry can be configured to have a desired expected lifespan appropriate for the type of prosthesis (or other device) with which the battery will be associated. For example, such a desired expected lifespan may range from 1 to 15 years or more, e.g., 10 years. In some embodiments, the battery is configured to power the IRP's electronic circuitry for the entire (e.g., 18 years or more) or expected lifespan of the IRP. An embodiment of such circuitry includes 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.

[0169] With LiCFx chemistry, a battery can provide approximately 360 milliamp hours (mAh) at 3.7 volts (V) over its lifetime, but every 5 mm of length added to the battery can increase this output by approximately 36 mAh (similarly, every 5 mm of length subtracted from the battery can decrease this output by approximately 36 mAh). Of course, other battery chemistries can be used if they can achieve the appropriate power requirements for a given application, subject to the application's size and lifetime requirements. Some additional potential battery chemistries include, but are not limited to, lithium-ion (Li-ion), lithium manganese dioxide (Li-MnO), silver vanadium oxide (SVO), lithium chloride (Li-SOCl), lithium iodide, and hybrid types consisting of combinations of the above chemistries, such as CFx-SVO.

[0170] Unfortunately, removing the prosthesis and replacing it with a battery is often undesirable, at least because it involves an invasive procedure that is relatively expensive and may have adverse side effects such as infection and pain. Therefore, the implantable reporting process (IRP) may include a power source (e.g., a battery) and a mechanism for managing the power output of the implanted power source so that the power source provides power for a sufficient period of time regardless of the power source's location within the patient's body. The IRP may include the only power source present in the intelligent implant.

[0171] The battery can be located directly in the prosthesis, can be configured to be disposed of as part of the implantable reporting processor, or can be configured to be disposed of in an area of ​​the body other than the intelligent implant.

[0172] Extended battery life The intelligent implant 1002 can operate in various modes to detect different types of movement. In this manner, when a certain type of movement is detected, the intelligent implant 1002 can increase, decrease, or otherwise control the amount and type of kinematic and other data collected.

[0173] In one example, the intelligent implant 1002 may determine whether the patient is moving. The implantable device 1002 may begin storing data in memory once it determines that movement has occurred for 10 seconds. In response to the determination, the amount and type of collected data may be started, stopped, increased, decreased, or otherwise appropriately controlled. The intelligent implant 1002 may further control data collection based on certain conditions, such as when the patient stops moving, when a selected maximum amount of data for that collection session has been collected, when the intelligent implant 1002 is turned off, or based on other conditions. After data has been collected in a particular session, the intelligent implant 1002 may stop collecting data until the next day, until the next time the patient is moving, after previously collected data has been offloaded (e.g., by transmitting the collected data to the home base station 1004), or according to one or more other conditions.

[0174] 9, the IRP 1003 of the intelligent implant may be configured to be placed into different operational modes. These modes may include, for example, a deep sleep mode, a standby mode, a low resolution mode, a medium resolution mode, and / or a high resolution mode.

[0175] Deep sleep mode. During deep sleep mode, the IRP 1003 is in an ultra-low power state during storage to maintain shelf life before implantation. In this mode, only the clock and power management circuitry 1020 and the wake-up circuitry of the RF transceiver 1026 are active. To this end, referring to FIG. 9 , the battery 1012 provides power to the clock and power management circuitry 1020, the RF transceiver 1026, and switches 1016, 1017, and 1018 are open to isolate the battery 1012 from the IMU 1022, the accelerometer 1023, and the memory 1024.

[0176] Standby mode.During standby mode, the IRP 1003 can be placed in a low power state while the implant is ready for wireless communication with external devices.

[0177] Low resolution mode. During low-resolution mode, the IRP 1003 detects and counts simple motion events and collects low-resolution linear acceleration data to detect significant motion. In some embodiments, low-resolution mode is characterized by activation of a first set of sensors (e.g., the individual accelerometer 1023 of the IMU 1022 or one or more accelerometers) that enables detection of simple motion events using a sampling rate ranging from 12 Hz to 100 Hz. To this end, referring to FIG. 9 , one of switches 1016, 1017 is closed to couple the battery 1012 to the IMU 1022 or the individual accelerometer 1023. When in low-resolution mode, the first set of sensors counts simple motion events and sends significant movement notifications to the controller 1032. In some embodiments, when exiting low-resolution mode, the IMU 1022 or the individual accelerometer 1023 reports the number of simple motion events to the controller 1032. Low-resolution mode may be entered at scheduled times and exited at scheduled times according to a sampling schedule. During the low resolution mode, data is collected continuously by the first set of sensors.

[0178] Medium resolution mode.During medium resolution mode, IRP 1003 collects both linear acceleration and rotational motion data. In some embodiments, medium resolution mode is characterized by activation of a second set of sensors (e.g., the three accelerometers and three gyroscopes of IMU 1022) that enables detection of linear acceleration and rotational velocity using a sampling rate ranging from 12 Hz to 100 Hz. To this end, referring to FIG. 9 , switch 1016 is closed to couple battery 1012 to IMU 1022. In some embodiments, medium resolution mode may be initiated when unspecified detection of a significant motion event occurs during a configured medium resolution window of a day, or by a manual command transmitted wirelessly from an external device, e.g., a base station. Medium resolution mode may be terminated after a predetermined event related to detected significant motion.

[0179] High resolution mode. In some embodiments, while in high resolution mode, the IRP1003 may collect linear acceleration data, or may collect both linear acceleration and rotational motion data, or may collect ultrasound data, or may collect a combination of all of the modalities described. In some embodiments, high-resolution mode is characterized by activation of a third set of sensors (e.g., acceleration data only or three accelerometers and three gyroscopes of IMU 1022 (if collecting both acceleration and rotational motion data)) that enables detection of acceleration and rotational motion data using a sampling rate ranging from 200 Hz to 5000 Hz. In some embodiments, high-resolution mode is characterized by activation of ultrasound sensors to detect implant position using a sampling rate ranging from 200 Hz to 20,000 Hz. To this end, referring to FIG. 9 , switch 1016 is closed, coupling battery 1012 to IMU 1022. In some examples, high-resolution mode can be initiated when a specified detection of a significant motion event occurs during a configured medium-resolution window of a day, or by a manual command sent wirelessly from an external device. High-resolution mode can have a built-in time limit after which acquisition automatically terminates.

[0180] One or more of these modes can be used to passively and autonomously collect data at various frequencies throughout the life of the intelligent implant, without patient involvement. The intelligent implant may begin collecting data on the second postoperative day and has the ability to store up to 30 days of data in memory. Thereafter, data is transmitted to the cloud daily. In some embodiments, if data cannot be transmitted due to connectivity issues with the base station, new data overwrites the oldest data when the implant reaches its memory limit. Additionally, the base station can store up to 45 days of transmitted data if it cannot connect to the cloud but can still communicate with the implant locally.

[0181] In some embodiments, intelligent implant 1002 may include a fourth set of sensors (e.g., a fourth accelerometer on IMU 1022) located on a separate board or circuit (not shown). In some examples, this separate board or circuit may receive power independently of powering intelligent implant 1002 / IMU 1022, which includes three sets of sensors. In some embodiments, this allows for powering a single accelerometer to detect whether walking is occurring, rather than providing power to the entire intelligent implant 1002 / IMU 1022 for the sole purpose of detecting whether walking is occurring.

[0182] Control circuit / controller / processor 8 and 9 , controller 1032, which may be any suitable microcontroller or microprocessor, may be configured to control the configuration and operation of one or more of the other components of electronics assembly 1010. For example, controller 1032 may be configured to control one or more measurement units 1022 to sense associated measurement data, store the measurement data generated by the one or more sensors in memory 1024, generate messages, include the stored data as payloads, packetize the messages, and provide the message packets to RF transceiver 1026 for transmission to a base station (not shown). Controller 1032 may also be configured to execute commands received from a base station (not shown) via antenna 1030, filter 1028, and RF transceiver 1026. For example, controller 1032 may be configured to receive configuration data from a base station and provide the configuration data to components of electronics assembly 1010 to which the base station directs the configuration data. When the base station directs the configuration data to controller 1032, the control circuitry is configured to configure itself in response to the configuration data.

[0183] IRP behavior With further reference to Figures 8 and 9, operation of the implantable reporting processor (IRP) will be described in relation to the implanted intelligent implant in which the IRP is located or with which the IRP is otherwise associated.

[0184] The normally electrically closed fuse 1014 is configured to electrically open in response to an event that could damage the patient in whom the electronics assembly 1010 resides or could damage the implantable circuit's battery 1012 if the event continues beyond a safe length of time. Conditions responsive to the fuse 1014 being able to electrically open include an overcurrent condition, an overvoltage condition, an overtemperature condition, an overcurrent-time condition, an overvoltage-time condition, and an overtemperature-time condition. An overcurrent condition occurs in response to the current through the fuse 1014 exceeding an overcurrent threshold. Similarly, an overvoltage condition occurs in response to a 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-time condition occurs in response to the integral of the current through the fuse 1014 over a measurement time window (e.g., 10 seconds) exceeding a current-time threshold, where the window can slide forward in time such that the window always moves back in units of the window length from the current time. Alternatively, an overcurrent condition occurs if the current through the fuse 1014 exceeds the overcurrent threshold for longer than a threshold time. Similarly, an overvoltage time condition occurs in response to the integral of the voltage across the fuse 1014 over a measurement time window, and an overtemperature time condition occurs in response to the integral of the temperature of the fuse over a measurement time window. Alternatively, an overvoltage time condition occurs if the voltage across the fuse 1014 exceeds the overvoltage threshold for more than a threshold time, and an overtemperature time condition occurs if the temperature associated with the fuse 1014, the battery 1012, or the electronics assembly 1010 exceeds the overtemperature threshold for more than a threshold time. However, even if the fuse 1014 opens and therefore disconnects power from the electronics assembly 1010, the mechanical and structural components of the intelligent implant (not shown in FIG. 8 ) are still fully operational.

[0185] The controller 1032 can cause one or more measurement units 1022 to measure patient movement, determine whether the measurements are qualified or valid measurements, store data representing the valid measurements, and cause the RF transceiver 1026 to transmit the stored data to a base station or other source external to the prosthesis.

[0186] 8 and 9, in response to being polled by a base station (not shown) or by another device external to the implanted 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 the sample partition within the payload, a timestamp indicating when the measurement unit 1022 acquired the sample, an identifier of the implantable prosthesis (e.g., a serial number), and a patient identifier (e.g., a number or name).

[0187] The controller 1032 can generate data packets containing the message according to a conventional data packetization protocol. Each packet can also include a packet header containing, for example, a packet sequence number, allowing a receiving device to properly sequence the packets as they are sent or received.

[0188] The controller 1032 can encrypt some or all of each of the data packets, for example, according to a conventional encryption algorithm, and error code the encrypted data packets. For example, the controller 1032 can encrypt at least the prosthesis and patient identifiers to make the data packets Health Insurance Portability and Accountability Act ("HIPAA") compliant.

[0189] Controller 1032 can provide the encrypted and error encoded data packets to RF transceiver 1026, which transmits the data packets via filter 1028 and antenna 1030 to base station 1004 (FIG. 7) or a destination external to the implantable prosthesis. RF transceiver 1026 can transmit the data packets according to any suitable data packet transmission protocol.

[0190] 8 and 9, alternative embodiments of electronics assembly 1010 are contemplated. For example, an RF transceiver can perform encryption or error coding in place of, or complementary to, controller 1032. Additionally, one or both of switches 1016 and 1018 can be omitted from electronics assembly 1010. Furthermore, electronics assembly 1010 can include components other than those described herein and can omit one or more of the components described herein.

[0191] base station FIG. 15 shows an embodiment of a diagram of base station circuitry 1040 configured for inclusion within or otherwise use with a base station, such as home base station 1004 of FIG. 7 , configured to communicate with electronics assembly 1010 of FIG. 8 or FIG. 9 , according to one embodiment described above.

[0192] composition In some embodiments, the base station circuitry 1040 is powered by a power source 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 circuitry 1058.

[0193] As mentioned above, the power source 1042 can be any suitable power source, such as a battery or a power source that receives power from a wall outlet; if the power source is of the latter type, the power source can also include a battery backup during power outages or when the base station circuitry 1040 is unplugged.

[0194] Antenna 1044 can be any antenna suitable for the frequency band over which RF transceiver 1052 communicates with electronics assembly 1010 of Figure 8 or Figure 9. Similarly, antenna 1046 can be any antenna suitable for the frequency band over which RF transceiver 1054 communicates with components, such as, for example, a WiFi router, access point, or repeater of home network 1006 of Figure 7.

[0195] In some embodiments, each of filters 1048 and 1050 may be any suitable bandpass filter, such as a surface acoustic wave (SAW) filter or a bulk acoustic wave (BAW) filter.

[0196] The RF transceiver 1052 may be a transceiver configured to enable the control circuitry 1058 to communicate with the electronics assembly 1010 of Figure 8 or 9 while the implant circuitry is disposed within or otherwise associated with the intelligent implant 1002 of Figure 7. For example, the RF transceiver 1052 may be any suitable type of transceiver (e.g., Bluetooth, Bluetooth Low Energy (BTLE), and WiFi), may be configured to operate according to any suitable protocol (e.g., MICS, ISM, Bluetooth, Bluetooth Low Energy (BTLE), and WiFi), and may be configured to operate in a frequency band within the range of 1 MHz to 5.4 GHz, or any other suitable range.

[0197] Similarly, RF transceiver 1054 may be any transceiver configured to enable control circuitry 1058 to communicate with components of home network 1006 of FIG. 7, such as a WiFi router, access point, or repeater, or with one or more of home base station 1004, smart device 1005, and connected personal assistant 1007 of FIG. 7. For example, RF transceiver 1026 may be any suitable type of transceiver (e.g., Bluetooth, Bluetooth Low Energy (BTLE), and WiFi), may be configured to operate according to any suitable protocol (e.g., MICS, ISM, Bluetooth, Bluetooth Low Energy (BTLE), and WiFi), and may be configured to operate in a frequency band within the range of 1 MHz to 5.4 GHz, or any other suitable range.

[0198] The memory 1056 may be any suitable non-volatile memory, such as an EEPROM or FFASH memory, and may be configured to store data written by the control circuitry 1058 and to provide data in response to read commands from the control circuitry. For example, the control circuitry 1058 may store in the memory 1056 data packets received from the electronics assembly 1010 of FIG. 15 or from a cloud server via the RF transceiver 1054, the data packets including, for example, commands, instructions, or configuration data for the electronics assembly 1010 of FIG. 8 or 9. Alternatively, the memory 1056 may include volatile memory.

[0199] The base station control circuitry 1058, which may be any suitable microcontroller or microprocessor, may be configured to control the configuration and operation of itself and one or more of the other components of the base station circuitry 1040. For example, the base station control circuitry 1058 may be configured to receive data packets from the electronics assembly 1010 of FIG. 8 or 9 via the RF transceiver 1052, convert the received data packets into data packets suitable for transmission to the home network 1006 of FIG. 7, and transmit the converted data packets to the home network via the RF transceiver 1054. The base station control circuitry 1058 may also be configured to receive data packets from the home network 1006 via the RF transceiver 1054, convert the received data packets into data packets suitable for transmission to the electronics assembly 1010 of FIG. 8 or 9, and transmit the converted data packets to the implantable circuit via the RF transceiver 1052.

[0200] With further reference to FIG. 15, the operation of the base station circuitry 1040 will now be described in conjunction with the implanted intelligent devices with which the base station circuitry communicates.

[0201] The control circuitry 1058 polls the electronics assembly 1010 (not shown in FIG. 8 or FIG. 9) of the implanted intelligent device (not shown) at regular intervals, such as once a day, once every other day, once a week, or once a month. If the control circuitry 1058 does not receive a response to a poll, the control circuitry may poll the electronics assembly 1010 more frequently (e.g., every 5 minutes, every 30 minutes, every hour) until it receives or determines that the implanted prosthesis is out of range of the base station.

[0202] The electronics assembly 1010 (FIG. 8 or FIG. 9) responds to the poll by transmitting all sample data packets of the one or more measurement units 1022 of the electronics assembly 1010 that have been generated since the last transmission of a data packet.

[0203] Antenna RF transceiver 1052 receives data packets from electronics assembly 1010 (FIG. 8 or FIG. 9) via antenna 1044 and filter 1048 and provides the received data packets to base station control circuitry 1058, which decodes and decodes the data packets, parses messages from the data packets, and stores the parsed messages in memory 1056. Before storing the parsed messages, base station control circuitry 1058 may encrypt a portion of each of the multiplexed messages to comply with the ULN.

[0204] The base station control circuitry 1058 then reformats the stored message or generates a new message in response to the header and payload of the stored message. For example, the base station control circuitry 1058 may generate new messages that each include the respective payload and header from the received message, but each include additional header information, such as an identifier of the base station 1004 (FIG. 8 or FIG. 9), the time of receipt of the original message from the electronics assembly 1010 (FIG. 8 or FIG. 9), and the time of creation of the new message. Before generating the new message, the base station control circuitry 1058 may decode the parsed message stored in memory 1056.

[0205] The base station control circuitry 1058 then generates data packets containing the new message, encrypts some or all of each of the data packets, error codes the data packets, and provides the encrypted and encoded data packets to the RF transceiver 1054, which transmits the encrypted and encoded data packets to the home network 1006 via the filter 1050 and the antenna 1046. The base station control circuitry 1058 may temporarily store the encrypted and encoded data packets in the memory 1056 (e.g., in a buffer) before providing the data packets to the RF transceiver 1054.

[0206] In an alternative embodiment, base station control circuitry 1058 "passes through" data packets received from electronics assembly 1010 (FIG. 8 or FIG. 9) to home network 1006 (FIG. 7). That is, base station control circuitry 1058 receives one or more data packets from electronics assembly 1010 via RF transceiver 1052, temporarily stores the one or more data packets in memory 1056, and causes RF transceiver 1054 to transmit the one or more data packets to home network 1006.

[0207] In yet another alternative, the control circuit 1058 modifies one or more data packets received from the electronics assembly 1010 (FIG. 8 or FIG. 9) without first parsing the one or more data packets, or using an analysis of some but not all of each data packet.

[0208] The home network 1006 (FIG. 7) may "pass through" one or more data packets received from the base station 1004 to a destination, such as a server on the cloud 1008 (FIG. 7), or may modify the one or more data packets in accordance with a suitable communication protocol before transmitting the one or more data packets to a destination.

[0209] Notwithstanding the above, it is recognized that any device (e.g., a smartphone, a home computer, a tablet, a wearable device, etc.) may be used as a home base station to perform any one or more of the base station functions described herein. For example, the device may be any device with a customized application that securely communicates, transfers, stores, and passes the functions required by the smart implant, thereby enabling secure data transfer to the smart implant's cloud-based data storage and analysis system. The device may have compatible wireless communication protocols and circuitry, such as, but not limited to, cellular, Wi-Fi, Zigbee, Bluetooth, or BTLF technology.

[0210] Clinical use While the following disclosure focuses on spinal fusion via implantation of an interbody spacer or spinal cage, the disclosure applies more generally to any of the medical implants disclosed herein. Currently, postoperative hospitalization monitoring for spinal fusion surgery is performed through personal visits by hospital staff and medical teams, patient physical examinations, medical monitoring (such as vital signs), range of motion (ROM) assessments, physical therapy (including early mobilization and activity), and diagnostic imaging studies and blood work as needed. Once the patient is admitted, patient satisfaction is checked during regular physician visits, and a complete history, physical examination, supplemental imaging, and diagnostic studies are used to monitor the patient's progress and identify the occurrence of potential complications. During such visits, the surgeon typically assesses the patient's range of motion, attempts to identify any pain that occurs during specific movements or activities, and questions the patient to determine activity level, daily function, pain control, and rehabilitation progress.

[0211] Unfortunately, most of a patient's recovery period occurs in the hospital and / or between visits. Therefore, from surgery to full recovery, it can be very difficult to accurately measure and follow the full range of motion (ROM can vary depending on pain control, the level of anti-inflammatory medication, the time of day, recent activity, and / or the patient's mood at the time of the examination), the patient's activity level, exercise tolerance, and the effectiveness of rehabilitation efforts (physical therapy, medications, etc.). For much of this information, physicians rely on patient self-report or third-party observation to gain insight into the effectiveness of postoperative treatment and the progress of recovery and rehabilitation. Often, this is further complicated by patients who are unsure of what to look for, do not understand what postoperative recovery should be, are non-compliant, or are unable to effectively communicate their symptoms. Furthermore, identifying and tracking complications (inpatient and non-inpatient) before they become symptomatic, before they arise between physician visits, or that are difficult for patients (and / or physicians) to detect also provides additional information valuable for managing a patient's recovery. Currently, in all cases, neither physicians nor patients have access to the type of "real-time," continuous, objective, prosthesis performance measurement that might otherwise be preferred.

[0212] The IMU of the active implant of the present disclosure can provide the surgeon with accurate, numerical, quantitative motion data that can be compared to expected values ​​to assess the effectiveness of post-operative treatment and can serve as a baseline value for comparison with post-operatively obtained functional values. Any abnormalities in vibration (e.g., micromotions that can indicate the likelihood of fusion), rotation (e.g., patient stiffness that can identify whether fusion has occurred), and acceleration (e.g., can determine patient movement such as walking speed) can be monitored, and clinicians can utilize this data to provide optimal patient care.

[0213] Immediately after spinal fusion and implantation of the lumbar interbody spacer or cage, and after an appropriate postoperative recovery period, the implant measures the patient's movement to determine quality of life measurements. This may include, for example, step count, cadence, average walking speed, center of gravity / angle, and / or flexion. Accelerometers can measure spinal motion and tracking during movement. As the patient continues to improve their range of motion after surgery, accelerations experienced at different locations along the spine (e.g., lumbar, thoracic, cervical) can be monitored. As the patient heals from surgery, activity levels are expected to gradually increase, and movement is expected to improve and increase. The effects of exercise and various activities can be monitored by various accelerometers and compared to the patient's subjective experience to determine which life activities are improving (or hindering) postoperative recovery and rehabilitation.

[0214] Integrating the sensors described herein (e.g., accelerometers and gyroscopes) with commercial analytical technologies such as pedometers allows for the collection of additional clinically relevant data, including, but not limited to, a patient's activity level (frequency, duration, and intensity of activity), exercise tolerance (work, calories, strength, and training effect), range of motion under various "real-world" conditions (discussed elsewhere herein), and prosthesis performance. The value of this information is difficult to overstate, allowing for better management of the patient's recovery. The treating physician (or physical therapist or rehabilitation specialist) will only perform in-person observations of the patient during scheduled office visits, and the patient's degree of function at the precise time of the examination may be affected by many different factors, including: presence or absence of pain, presence or absence of inflammation, stiffness, time of day, compliance and timing of medication use (pain medications, anti-inflammatory medications), recent activity and exercise levels, the patient's strength, mental state, language barriers, the nature of the physician-patient relationship, and the patient's ability to accurately describe their symptoms. Continuous monitoring and data collection allows patients and physicians to objectively monitor progress by providing objective information about patient function under multiple conditions and circumstances, assess how performance is affected by various interventions (pain control, exercise, physical therapy, anti-inflammatory medications, rest, etc.), and compare rehabilitation progress with previous function and future projected function. Better treatment decisions and better patient compliance can be expected when both physicians and patients have the advantage of observing the effects of various treatment modalities on the patient's rehabilitation, activity, function, and overall performance.

[0215] The purpose of the intelligent implants included herein is to provide an improved quality of life for patients, address the causes of pain (e.g., multifocal and radiating), and facilitate pain management. Determination of a patient's status can be made directly and / or indirectly. As discussed above, indirect measurements of a patient's status can be determined by considering the patient's quality of life. For example, a physician may consider whether a patient's mobility increases or decreases over time, whether the patient is able to return to activities they previously enjoyed (e.g., exercise, diet, recreation), whether the patient is able to continue to care for themselves or maintain their independence, etc. Each of these examples can be determined by raw data generated by an accelerometer and gyroscope on the implantable reporting processor. This raw data can be stored and uploaded to a cloud where the data is used to determine the patient's movement, such as, for example, step count, cadence, average walking speed, and the patient's center of gravity.

[0216] In some embodiments, because indirect measurements and calculations of kinematic data are made under excitation (e.g., loading and movement), the intelligent implant can determine the patient's baseline movement (e.g., when the patient is static) to use as a standard reference. This standard reference can be used to determine the patient's relative reference (e.g., how quickly the patient returns to normal activities). In some embodiments, the patient's standard reference can be determined by performing a patient calibration after surgery (e.g., spinal fusion) is completed. In some examples, a boundary is taken that sets a reference at a known location. This can be, for example, when the patient is against a wall or in a known position (e.g., with the patient's back straight or at a predetermined angle).

[0217] In addition to monitoring the patient's kinematic information, the intelligent implant can monitor other data points that may indicate potential patient discomfort or problems during recovery. For example, sensors within the intelligent implant can monitor the patient's posture. In some embodiments, the intelligent implant can be configured to monitor range of motion (ROM) at the fusion point (e.g., lumbar ROM, cervical ROM, thoracic ROM). In some examples, the intelligent implant can detect whether an implant screw has loosened. As discussed in more detail below, the intelligent implant determines, through direct and indirect measurements, whether interbody fusion has occurred, whether an interbody spacer has migrated, and / or whether there is subsidence of the segment in which the intelligent implant is implanted.

[0218] In some embodiments, an indirect measurement of patient improvement can be made by measuring the fusion, migration, and subsidence of the intelligent implant. Inertial measurement movement can be used to generate kinematic data for measuring the amount of fusion, migration, and / or subsidence of the intelligent implant.

[0219] fusion. Once the interbody spacer or spinal cage is press-fit into the space between two adjacent vertebrae, the fusion system measures the amount of micromotion within the interbody spacer or spinal cage to determine whether the two adjacent vertebrae have fused. If micromotion is detected, it indicates to the physician that the patient's spine has not fully fused.

[0220] Move.The movement determines the amount of translational movement of the interbody spacer or spinal cage positioned between the vertebrae from its initial implantation location. In some embodiments, an inertial measurement unit on the implantable reporting processor can determine the patient's step count, cadence, average walking speed, angle of movement, etc. As described above, an increase and / or decrease in movement of the intelligent implant (i.e., interbody spacer or spinal cage) can indirectly indicate whether the patient's condition is improving. For example, if the patient's movement is decreasing or there is a change in the angle of movement or cadence, this can indicate to the physician that the patient is suffering from pain, which may be due to implant movement and the resulting loss in spacing between the associated vertebral bodies.

[0221] Subsidence. Subsidence measures the reduction in vertical height of the intervertebral disc space before complete fusion. Subsidence of the disc space between adjacent vertebrae is an important consideration because it can adversely affect mechanical correction and clinical outcomes. Because a patient's bone consistency may vary and / or the amount of bone preparation of the host site by the physician may vary, the amount of potential subsidence experienced by the patient may change after a spinal fusion is performed. In some embodiments, changes in the patient's gait, as detected by the inertial measurement unit, may be associated with a decrease in spinal height and associated pain due to nerve compression. This can indicate to the physician that subsidence has occurred. In this case, the physician may refer the patient for direct imaging studies to make a final diagnosis.

[0222] In addition to indirect measurements, the presently disclosed intelligent implants can be used to provide direct measurements of interbody spacer or spinal cage movement and subsidence. As shown in Figures 1A-1C, 2A-2D, and 3 provided herein, an implantable reporting processor (e.g., implantable reporting processor 150, 250) can include multiple sensors positioned on the top, bottom, medial, and lateral surfaces to directly measure movement of the interbody spacer or spinal cage.

[0223] Move.As described above, the movement is measured by measuring the movement of the interbody spacer or spinal cage. In some embodiments, at least one ultrasonic sensor positioned on the inner surface of the cartridge can scan the inside and outside of the interbody spacer or spinal cage to measure the distance between the interbody spacer or spinal cage and anatomic references, thereby directly measuring the amount of movement it has experienced from its initial implant position. In some embodiments, the movement of the interbody space or spinal cage can be measured through angle detection (e.g., through a tilt sensor). The movement can be determined by sampling data that measures the position of the interbody spacer or spinal cage when the patient is in a known position. For example, a physician can take movement measurements while the patient is sitting in a chair or standing during a clinic visit. Alternatively, measurements of the position of the interbody spacer or spinal cage can be taken at a time when the patient is in a known position (e.g., at night while the patient is sleeping). In some embodiments, a gyroscope can be useful in determining the orientation of the interbody spacer or spinal cage.

[0224] Sedimentation. As described above, subsidence measures the vertical height of the intervertebral disc. In some embodiments, at least one ultrasonic sensor positioned on the top and bottom surfaces of the cartridge 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 the adjacent vertebrae and the surface of the interbody spacer or spinal cage from the distance measured at the time of implantation can indicate to the physician that the disc height has decreased and subsidence has occurred.

[0225] As described above, intelligent implants can be used as diagnostic tools to help physicians understand the success of a spinal fusion. For example, indirect and direct determination of fusion, migration, and subsidence of an interbody spacer or spinal cage can provide physicians with data to help diagnose the cause of a patient's discomfort or pain after a spinal fusion. Information provided by intelligent implants can aid in pain management and / or the patient's return to normal activities.

[0226] Disclaimer The devices, methods, systems, etc. of the present disclosure are described broadly and generically herein. Each of the narrower species and subgeneric groupings falling within the generic disclosure also form part of this disclosure. This includes the general description of the devices, methods, systems, etc. of the present disclosure, with any proviso or negative limitation removing any subject matter from the genus, regardless of whether the excised material is specifically recited herein.

[0227] As used herein, the relative terms "medial," "lateral," "anterior," and "posterior" should be defined from the perspective of the device, not necessarily the anatomy. For example, a sensor on the lateral end may anatomically face in the posterior direction to detect anterior movement.

[0228] As used in this specification and the appended claims, unless the context clearly dictates otherwise, 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," and it should also be understood that the letter "s" denotes both the plural and the singular form of that noun. Furthermore, when features or aspects of the disclosure are described in terms of a Markush group, the disclosure is intended to encompass and be described by any individual members and any subgroups of members of the Markush group, as one of skill in the art would recognize. Applicant reserves the right to amend this application or the claims to specifically refer to any individual member or any subgroup of members.

[0229] It is to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting. It is to be further understood that, unless specifically defined herein, terms used herein are to be given their conventional meanings known in the relevant art.

[0230] Throughout this specification, references to "one embodiment" or "one embodiment" and variations thereof mean that a particular feature, structure, or characteristic described in connection with an embodiment is included in at least one embodiment. Thus, the appearances of the phrase in various places throughout this specification do not necessarily all refer to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0231] As used herein and in the appended claims, the singular includes plural references, i.e., one or more, unless the content and context clearly dictate otherwise. For example, the term "sensor" refers to one or more sensors, and the term medical device comprising a sensor refers to a medical device including at least one sensor. A plurality of sensors refers to two or more sensors. Also, note that the conjunction "and" is generally used in its broadest sense to include "and / or" unless the content and context clearly dictate inclusiveness or exclusiveness, as the case may be. Thus, the use of alternatives (e.g., "or") should be understood to mean either one, both, or any combination thereof. Additionally, when listed as "and / or," the "and" composition is intended to encompass embodiments that include all associated items or ideas, as well as one or more other alternative embodiments that include less than all associated items or ideas.

[0232] Unless the context requires otherwise, throughout the following specification and claims, the words "comprises" and their equivalents, and variations thereof, such as "comprises" and "comprises," and variations thereof, such as "comprises" and "comprises," are to be interpreted in an open and inclusive sense, e.g., "including, but not limited to." The term "consisting essentially of" limits a claim to particular materials or steps, or to materials or steps that do not materially affect the basic and novel characteristics of the claimed invention.

[0233] The headings used within this document are utilized solely to facilitate the reader's review thereof and should not be construed as limiting the scope of the disclosure, invention, or claims in any way. Accordingly, the headings and abstracts of the disclosure provided herein are merely for convenience and do not interpret the scope or meaning of the embodiments.

[0234] Where a range of values ​​is provided herein, unless the context clearly dictates otherwise, it is understood that each intervening value, to the tenth of the unit of the lower limit, between the upper and lower limits of that range, and any other stated or intervening value within that stated range, is encompassed within the scope of the disclosure, invention, or claims. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges and are also encompassed within the disclosure, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the disclosure.

[0235] For example, any concentration range, percentage range, ratio range, or integer range provided herein should be understood to include any integer value within the recited range, and fractions thereof (such as tenths and hundredths of integers), where appropriate, unless otherwise indicated. Also, any numerical range recited herein relating to any physical characteristic, such as polymer subunits, size, or thickness, should be understood to include any integer within the recited range, unless otherwise indicated. As used herein, the term "approximately" means ±20% of the indicated range, value, or structure, unless otherwise indicated.

[0236] All U.S. patents, U.S. patent application publications, U.S. patent applications, foreign patents, foreign patent applications, and non-patent publications mentioned herein and / or listed in the Application Data Sheet are incorporated herein by reference in their entirety. Such documents may be incorporated by reference, for example, for the purpose of describing and disclosing materials and methodology described in the publications that might be used in connection with the present disclosure. The publications discussed above and throughout the text are provided solely for their disclosure prior to the filing date of the present application. Nothing herein should be construed as an admission that the inventors are not entitled to antedate any reference by virtue of prior invention.

[0237] All patents, publications, scientific articles, websites, and other documents and materials referenced or mentioned in this specification are indicative of the level of skill of those skilled in the art to which this disclosure pertains, and each such referenced document and material is incorporated by reference herein to the same extent as if it were individually incorporated by reference in its entirety or as if set forth by reference in its entirety herein. Applicant reserves the right to physically incorporate into this specification all materials and information from such patents, publications, scientific articles, websites, electronically available information, and other referenced materials or documents.

[0238] In general, in the following claims, the terms used should not be construed to limit the claims to the specific embodiments disclosed in the specification and the claims, but should be construed to include all possible embodiments, along with the full scope of equivalents to which such claims are entitled. Accordingly, the claims are not limited by the present disclosure.

[0239] Further, the written description portion of this patent includes all claims. Moreover, all claims, including all original claims and all claims from any and all priority documents, are incorporated by reference in their entirety into the written description portion of this specification, and applicant reserves the right to physically incorporate any and all such claims into the description or any other portion of this application. Thus, for example, under no circumstances will a patent be construed as failing to provide a written description of a claim with respect to an allegation that the exact wording of the claim is not recited in Heck language in the written description portion of the patent.

[0240] The claims are to be interpreted in accordance with law. However, notwithstanding any alleged or perceived ease or difficulty in interpreting the claims or portions thereof, under any circumstances, any adjustment or modification of the claims or portions thereof during the prosecution of this application leading to this patent may be construed as a prejudice to any and all equivalents thereof that do not form part of the prior art.

[0241] Other non-limiting embodiments are within the scope of the following claims. A patent may not be construed as limited to the particular examples or non-limiting embodiments or methods specifically and / or expressly disclosed herein. Under no circumstances may a patent be construed as limited by an oath taken by an examiner or other officer or employee of the Patent and Trademark Office, unless such oath is expressly qualified or reserved in writing by the applicant.

[0242] As noted above, in the following claims, the terms used should not be construed to limit the claims to the specific embodiments disclosed in the specification and the claims, but should be construed to include all possible embodiments, along with the full scope of equivalents to which such claims are entitled. For example, a described embodiment having one or more omitted components or steps may be an additional embodiment contemplated and covered by the present application.

[0243] Illustrative Embodiments Embodiment 1: 1. An implantable sensor assembly for use during spinal fusion, comprising: an implantable prosthesis component; an implantable cartridge associated with a component, at least one sensor capable of detecting one or more kinematic measurements associated with the patient and generating sensor data; An implantable sensor assembly comprising: a cartridge comprising an antenna in electrical communication with at least one sensor, the antenna transmitting sensor data to a receiver at a remote location.

[0244] Embodiment 2: 2. The implantable sensor assembly of embodiment 1, wherein the implantable cartridge further comprises a battery.

[0245] Embodiment 3: 2. An implantable sensor assembly as described in embodiment 1, wherein the implantable cartridge further comprises an inertial measurement unit having a plurality of accelerometers and / or a plurality of gyroscopes.

[0246] Embodiment 4: The inertial measurement unit a first accelerometer and / or a first gyroscope for measuring data related to a first measurement axis; a second accelerometer and / or a second gyroscope for measuring data related to a second measurement axis; An implantable sensor assembly as described in embodiment 3, comprising a third accelerometer and / or a third gyroscope for measuring data related to a third measurement axis.

[0247] Embodiment 5: 2. An implantable sensor assembly as described in embodiment 1, wherein the implantable cartridge has a circular, oval, square, or rectangular cross section and length.

[0248] Embodiment 6: 2. An implantable sensor assembly as described in embodiment 1, wherein the implantable cartridge has a cross-section with corner radii associated with a square or rectangular cross-section.

[0249] Embodiment 7: 2. An implantable sensor assembly as described in embodiment 1, wherein the implantable cartridge is positioned within the component.

[0250] Embodiment 8: 2. An implantable sensor assembly as described in embodiment 1, wherein the implantable cartridge is insertable into a slot in the component.

[0251] Embodiment 9: 2. An implantable sensor assembly as described in embodiment 1, wherein the implantable cartridge is mechanically coupled to the component.

[0252] Embodiment 10: 9. An implantable sensor assembly according to embodiment 8, wherein the implantable cartridge is reversibly coupled to the component.

[0253] Embodiment 11: 9. An implantable sensor assembly as described in embodiment 8, wherein the implantable cartridge forms a unidirectional positive connection with the component.

[0254] Embodiment 12: 9. An implantable sensor assembly as described in embodiment 8, wherein the implantable cartridge is mechanically coupled to the component using at least one of a corresponding snap ring, lock, twist, torsion, or chemical adhesive.

[0255] Embodiment 13: 9. An implantable sensor assembly as described in embodiment 8, wherein the cartridge is press-fit into the component.

[0256] Embodiment 14: 2. An implantable sensor assembly as described in embodiment 1, wherein the implantable cartridge comprises a plurality of sensors positioned on a top surface of the implantable cartridge.

[0257] Embodiment 15: 15. An implantable sensor assembly according to embodiment 14, wherein the implantable cartridge comprises a plurality of sensors positioned on a bottom surface of the implantable cartridge.

[0258] Embodiment 16: 16. An implantable sensor assembly according to embodiment 15, wherein the implantable cartridge comprises at least one sensor positioned on a proximal surface of the implantable cartridge.

[0259] Embodiment 17: 17. An implantable sensor assembly according to embodiment 16, wherein the implantable cartridge comprises at least one sensor positioned on a distal surface of the implantable cartridge.

[0260] Embodiment 18: An implantable sensor assembly as described in embodiment 16, wherein a plurality of sensors positioned on the top surface of the implantable cartridge and a plurality of sensors positioned on the bottom surface of the implantable cartridge are configured to measure sedimentation of the implantable sensor assembly.

[0261] Embodiment 19: An implantable sensor assembly as described in embodiment 17, wherein at least one sensor positioned on the proximal surface of the implantable cartridge and the distal surface of the implantable cartridge provides movement related to the translational direction and orientation of the implantable sensor assembly.

[0262] Embodiment 20: 15. An implantable sensor assembly according to embodiment 14, wherein the plurality of sensors positioned on the top surface of the implantable cartridge are in series.

[0263] Embodiment 21: 16. An implantable sensor assembly according to embodiment 15, wherein the plurality of sensors positioned on the bottom surface of the implantable cartridge are in series.

[0264] Embodiment 22: An implantable sensor assembly as described in embodiment 1, wherein the implantable cartridge comprises a series of three sensors on a top surface of the implantable cartridge, a series of three sensors on a bottom surface of the implantable cartridge, a plurality of sensors on a proximal end of the implantable cartridge, and a plurality of sensors on a distal end of the implantable cartridge.

[0265] Embodiment 23: 2. An implantable sensor assembly as described in embodiment 1, wherein the antenna extends from the proximal or distal end of the implantable cartridge.

[0266] Embodiment 24: 2. An implantable sensor assembly as described in embodiment 1, wherein the antenna is contained within a gap of the component.

[0267] Embodiment 25: 22. An implantable sensor assembly according to embodiment 21, wherein the antenna is contained within a component whose material composition allows for signal transmission from the antenna.

[0268] Embodiment 26: 26. An implantable sensor assembly as described in embodiment 25, wherein the component comprises PEEK.

[0269] Embodiment 27: 2. An implantable sensor assembly as described in embodiment 1, further comprising a processor.

[0270] Embodiment 28: 2. An implantable sensor assembly as described in embodiment 1, wherein the implantable prosthesis component is an interbody spacer for use during spinal fusion.

[0271] Embodiment 29: 29. An implantable sensor assembly as described in embodiment 28, wherein the interbody spacer is a lumbar interbody spacer.

[0272] Embodiment 30: 29. An implantable sensor assembly as described in embodiment 28, wherein the interbody spacer is a cervical interbody spacer.

[0273] Embodiment 31: 29. An implantable sensor assembly as described in embodiment 28, wherein the interbody spacer is a thoracic interbody spacer.

[0274] Embodiment 32: 2. The implantable sensor assembly of embodiment 1, wherein at least one sensor is an ultrasound sensor.

[0275] Embodiment 33: 33. An implantable sensor assembly as described in embodiment 32, wherein the ultrasound sensor is an M-mode sensor.

[0276] Embodiment 34: 33. An implantable sensor assembly as described in embodiment 32, wherein the ultrasound sensor is a B-mode sensor.

[0277] Embodiment 35: 33. An implantable sensor assembly according to embodiment 32, wherein the ultrasonic sensor is a low-power sensor.

[0278] Embodiment 36: 2. An implantable sensor assembly as described in embodiment 1, wherein the antenna is a loop antenna.

[0279] Embodiment 37: 2. An implantable sensor assembly as described in embodiment 1, wherein the antenna is a conformal antenna.

[0280] Embodiment 38: 2. An implantable sensor assembly as described in embodiment 1, wherein the antenna continuously transmits sensor data.

[0281] Embodiment 39: 2. An implantable sensor assembly as described in embodiment 1, wherein the antenna transmits sensor data intermittently.

[0282] Embodiment 40: 2. An implantable sensor assembly as described in embodiment 1, wherein at least one sensor continuously detects one or more physiological parameters.

[0283] Embodiment 41: 2. An implantable sensor assembly as described in embodiment 1, wherein at least one sensor intermittently detects one or more physiological parameters.

[0284] Embodiment 42: 2. The implantable sensor assembly of embodiment 1, further comprising a power source for providing power to the at least one sensor.

[0285] Embodiment 43: 43. An implantable sensor assembly as described in embodiment 42, wherein the power source is rechargeable.

[0286] Embodiment 44: 2. The implantable sensor assembly of embodiment 1, wherein at least one sensor is capable of being powered by a power source outside the patient's body.

[0287] Embodiment 45: 2. An implantable sensor assembly as described in embodiment 1, further comprising a memory device for storing data from the at least one sensor.

[0288] Embodiment 46: 10. An implantable sensor assembly as described in embodiment 1, further comprising a storage device having sufficient memory to allow firmware upgrade of the implantable sensor assembly.

[0289] Embodiment 47: 1. A spinal implant assembly for use during spinal fusion, comprising: Interbody spacers and a cartridge mechanically coupled to an interbody spacer, a cartridge 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 sensor, the antenna providing two-way data communication to a receiver at a remote location; A spinal implant assembly, wherein the cartridge is insertable into a mating female cavity in the interbody spacer.

[0290] Embodiment 48: 48. The spinal implant assembly of embodiment 47, wherein the interbody spacer further comprises a battery.

[0291] Embodiment 49: 48. The spinal implant assembly of embodiment 47, wherein the interbody spacer further comprises an inertial measurement unit having a plurality of accelerometers and a plurality of gyroscopes.

[0292] Embodiment 50: The inertial measurement unit a first accelerometer and a first gyroscope for measuring data related to a first measurement axis; a second accelerometer and a second gyroscope for measuring data associated with a second measurement axis; 50. The spinal implant assembly of embodiment 49, comprising a third accelerometer and a third gyroscope for measuring data associated with a third measurement axis.

[0293] Embodiment 51: 48. The spinal implant assembly of embodiment 47, wherein the cartridge has a circular, oval, square, or rectangular cross-section as well as a length.

[0294] Embodiment 52: 48. The spinal implant assembly of embodiment 47, wherein the cartridge cross section has corner radii associated with a square or rectangular cross section.

[0295] Embodiment 53: 48. The spinal implant assembly of embodiment 47, wherein the cartridge is mechanically coupled to the interbody spacer.

[0296] Embodiment 54: 48. The spinal implant assembly of embodiment 47, wherein the cartridge is reversibly coupled to the interbody spacer.

[0297] Embodiment 55: 48. The spinal implant assembly of embodiment 47, wherein the cartridge forms a unidirectional positive connection with the interbody spacer.

[0298] Embodiment 56: 48. The spinal implant assembly of embodiment 47, wherein the cartridge is mechanically coupled to the interbody spacer using at least one of a corresponding snap ring, lock, twist, torsion, or chemical adhesive.

[0299] Embodiment 57: 48. The spinal implant assembly of embodiment 47, wherein the cartridge is press-fit into the interbody spacer.

[0300] Embodiment 58: 48. The spinal implant assembly of embodiment 47, wherein the cartridge comprises a plurality of sensors positioned on an upper surface of the cartridge.

[0301] Embodiment 59 59. A spinal implant assembly as described in embodiment 58, wherein the cartridge comprises a plurality of sensors positioned on a bottom surface of the cartridge.

[0302] Embodiment 60: 60. The spinal implant assembly of embodiment 59, wherein the cartridge comprises at least one sensor positioned on a proximal surface of the cartridge.

[0303] Embodiment 61: 61. The spinal implant assembly of embodiment 60, wherein the cartridge comprises at least one sensor positioned on a distal surface of the cartridge.

[0304] Embodiment 62: 60. A spinal implant assembly as described in embodiment 59, wherein a plurality of sensors positioned on the top surface of the cartridge and a plurality of sensors positioned on the bottom surface of the cartridge are configured to measure subsidence of the interbody spacer.

[0305] Embodiment 63: 62. The spinal implant assembly of embodiment 61, wherein at least one sensor positioned on the proximal surface of the cartridge and the distal surface of the cartridge provides translational and orientation-related movement of the interbody spacer.

[0306] Embodiment 64: 59. The spinal implant assembly of embodiment 58, wherein the multiple sensors positioned on the top surface of the cartridge are in series.

[0307] Embodiment 65: 60. The spinal implant assembly of embodiment 59, wherein the multiple sensors positioned on the bottom surface of the cartridge are in series.

[0308] Embodiment 66: 48. A spinal implant assembly as described in embodiment 47, wherein the cartridge includes 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.

[0309] Embodiment 67: 48. The spinal implant assembly of embodiment 47, wherein the antenna extends from the proximal or distal end of the cartridge.

[0310] Embodiment 68: 48. A spinal implant assembly as described in embodiment 47, further comprising a processor.

[0311] Embodiment 69: 48. The spinal implant assembly of embodiment 47, wherein the interbody spacer is inserted into a portion of the patient's lumbar spine.

[0312] Embodiment 70: 48. The spinal implant assembly of embodiment 47, wherein the interbody spacer is inserted into a portion of the patient's cervical spine.

[0313] Embodiment 71: 48. The spinal implant assembly of embodiment 47, wherein the interbody spacer is inserted into a portion of the patient's thoracic spine.

[0314] Embodiment 72: 48. The spinal implant assembly of embodiment 47, wherein at least one sensor is an ultrasonic sensor.

[0315] Embodiment 73: 73. The spinal implant assembly of embodiment 72, wherein the ultrasonic sensor is an M-mode sensor.

[0316] Embodiment 74: 73. The spinal implant assembly of embodiment 72, wherein the ultrasound sensor is a B-mode sensor.

[0317] Embodiment 75: 73. The spinal implant assembly of embodiment 72, wherein the ultrasonic sensor is a low-power sensor.

[0318] Embodiment 76: 48. The spinal implant assembly of embodiment 47, wherein the antenna is a loop antenna.

[0319] Embodiment 77: 48. The spinal implant assembly of embodiment 47, wherein the antenna is a conformal antenna.

[0320] Embodiment 78: 48. The spinal implant assembly of embodiment 47, wherein the antenna continuously transmits sensor data.

[0321] Embodiment 79: 48. The spinal implant assembly of embodiment 47, wherein the antenna transmits sensor data intermittently.

[0322] Embodiment 80: 48. The spinal implant assembly of embodiment 47, wherein at least one sensor continuously detects one or more physiological parameters.

[0323] Embodiment 81: 48. The spinal implant assembly of embodiment 47, wherein at least one sensor intermittently detects one or more physiological parameters.

[0324] Embodiment 82: 48. The spinal implant assembly of embodiment 47, further comprising a power source for providing power to the at least one sensor.

[0325] Embodiment 83: 83. The spinal implant assembly of embodiment 82, wherein the power source is rechargeable.

[0326] Embodiment 84: 48. The spinal implant assembly of embodiment 47, wherein the at least one sensor is capable of being powered by a power source outside the patient's body.

[0327] Embodiment 85: 48. The spinal implant assembly of embodiment 47, further comprising a memory device for storing data from the at least one sensor.

[0328] Embodiment 86: 1. A method for sampling data from an implantable cartridge coupled to an interbody spacer implanted in a patient, comprising: Detecting one or more kinematic measurements associated with patient movement to generate sensor data; A method comprising: transmitting sensor data to a receiver at a remote location; and receiving the data from the receiver.

[0329] Embodiment 87: 87. The method of embodiment 86, wherein detecting one or more kinematic measurements occurs during patient movement.

[0330] Embodiment 88: 87. The method of embodiment 86, wherein detecting one or more kinematic measurements occurs while the interbody spacer is under load.

[0331] Embodiment 89: 87. The method of embodiment 86, wherein the method further comprises calibrating the implantable cartridge when the patient is in a known position.

[0332] Embodiment 90: 90. The method of embodiment 89, wherein the known position is when the patient is lying down.

[0333] Embodiment 91 90. The method of embodiment 89, wherein the known position is when the patient is standing against a wall.

[0334] Embodiment 92: 90. The method of 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.

[0335] Embodiment 93: 93. The method of embodiment 92, wherein the predetermined angle is 30 degrees, 45 degrees, or 90 degrees.

[0336] EMBODIMENT 94: 88. The method of embodiment 87, wherein one or more kinematic measurements are used to determine fusion of the interbody spacer.

[0337] EMBODIMENT 95 88. The method of embodiment 87, wherein one or more kinematic measurements are used to determine subsidence of the interbody spacer.

[0338] EMBODIMENT 96: 96. The method of embodiment 95, wherein the subsidence measures the amount of force exerted by the vertebrae adjacent to the interbody spacer.

[0339] EMBODIMENT 97 88. The method of embodiment 87, wherein one or more kinematic measurements are used to determine movement of the interbody spacer.

[0340] EMBODIMENT 98: 98. The method of embodiment 97, wherein the movement measures the translation of the interbody spacer at the implantation point.

[0341] EMBODIMENT 99: 87. The method of embodiment 86, wherein the movement measures a change in the kinematics of the interbody spacer at the point of implantation.

[0342] EMBODIMENT 100:87. The method of embodiment 86, wherein one or more kinematic measurements are used to determine patient movement.

[0343] EMBODIMENT 101: 99. The method of embodiment 98, wherein the determined patient movement is at least one of step count, cadence, walking speed, angle of movement, and gait.

[0344] Embodiment 102: 87. The method of embodiment 86, further comprising determining how quickly the patient is able to return to normal activity.

[0345] Embodiment 103: said implantable cartridge comprising: at least one sensor capable of detecting one or more kinematic measurements associated with the patient and generating sensor data; 87. The method of embodiment 86, comprising an antenna in electrical communication with at least one sensor, the antenna transmitting sensor data to a receiver at a remote location and receiving data from the receiver.

[0346] Embodiment 104: 102. The method of embodiment 101, wherein the implantable cartridge further comprises a battery.

[0347] Embodiment 105: 87. The method of embodiment 86, wherein detecting one or more kinematic measurements includes obtaining one or more kinematic measurements from an inertial measurement unit having multiple accelerometers and / or multiple gyroscopes.

[0348] EMBODIMENT 106: measuring data related to a first measurement axis, the data related to the first measurement axis being obtained from a first accelerometer and a first gyroscope of the inertial measurement unit; measuring data related to a second measurement axis, the data related to the second measurement axis being obtained from a second accelerometer and a second gyroscope of the inertial measurement unit; 106. The method of embodiment 105, further comprising measuring data related to a third measurement axis, wherein the data related to the third measurement axis is obtained from a third accelerometer and a third gyroscope of the inertial measurement unit.

[0349] EMBODIMENT 107: 1. A spinal implant assembly for use during spinal fusion, comprising: 1. A spinal implant comprising: The main body and an opening on the first end of the body; a cavity extending through the body of the spinal implant from the opening toward a second end of the body; a cartridge configured to be inserted into the cavity, the cartridge comprising an outer wall configured to house a plurality of components; and a spinal implant.

[0350] EMBODIMENT 108: 108. The spinal implant assembly of embodiment 107, further comprising a locking structure for securing the spinal implant with the cartridge.

[0351] Embodiment 109: 108. The spinal implant assembly of embodiment 107, wherein at least one of the upper body surface or the lower body surface includes a plurality of ridges, the plurality of ridges being configured to improve engagement of the spinal implant with adjacent vertebrae.

[0352] EMBODIMENT 110: 108. The spinal implant assembly of embodiment 107, further comprising a hole extending from the top surface of the body to the bottom surface of the body, the hole in the spinal implant configured to be filled with a biological or synthetic material to assist in spinal fusion.

[0353] EMBODIMENT 111: 108. A spinal implant assembly as described in embodiment 107, wherein the cartridge includes a power source.

[0354] EMBODIMENT 112: 112. The spinal implant assembly of embodiment 111, wherein the power source is either a single-use or rechargeable battery.

[0355] Embodiment 113: 108. A spinal implant assembly as described in embodiment 107, wherein the cartridge comprises an antenna.

[0356] EMBODIMENT 114: 114. The spinal implant assembly of embodiment 113, wherein the antenna is positioned on a cartridge within the opening of the spinal implant.

[0357] Embodiment 115: 114. A spinal implant assembly as described in embodiment 113, wherein the antenna is positioned within the outer wall of the cartridge.

[0358] EMBODIMENT 116: 114. The spinal implant assembly of embodiment 113, wherein the antenna is at least one of a loop antenna and a conformal antenna.

[0359] Embodiment 117: 114. A spinal implant assembly as described in embodiment 113, wherein the antenna continuously transmits sensor data.

[0360] Embodiment 118: 114. A spinal implant assembly as described in embodiment 113, wherein the antenna transmits sensor data intermittently.

[0361] Embodiment 119: 108. A spinal implant assembly as described in embodiment 107, wherein the cartridge comprises a processor.

[0362] Embodiment 120: 108. A spinal implant assembly as described in embodiment 107, wherein the cartridge comprises at least one sensor.

[0363] Embodiment 121: 121. The spinal implant assembly of embodiment 120, wherein at least one sensor is an ultrasonic sensor.

[0364] Embodiment 122: 122. The spinal implant assembly of embodiment 121, wherein the ultrasonic sensor is a low-power sensor.

[0365] Embodiment 123: 121. The spinal implant assembly of embodiment 120, wherein at least one sensor detects one or more physiological parameters continuously or intermittently.

[0366] Embodiment 124: 121. The spinal implant assembly of embodiment 120, wherein the cartridge comprises a memory device for storing data from the at least one sensor.

[0367] Embodiment 125: 108. The spinal implant assembly of embodiment 107, wherein the cartridge has a circular, oval, square, or rectangular cross-section and length.

[0368] Embodiment 126: 108. The spinal implant assembly of embodiment 107, wherein the outer wall has a wall thickness of about 0.5 mm.

[0369] Embodiment 127: 108. The spinal implant assembly of embodiment 107, wherein the outer wall has a wall thickness of less than 1 mm.

[0370] Embodiment 128: 108. The spinal implant assembly of embodiment 107, wherein the cartridge has a width-to-height ratio of 1:2.

[0371] Embodiment 129: 108. The spinal implant assembly of embodiment 107, wherein the cartridge has a width-to-height ratio of 2:3.

[0372] Embodiment 130: 108. The spinal implant assembly of embodiment 107, wherein the cartridge has a width of 8 mm, a thickness of 4 mm, and a length of 28 mm.

[0373] Embodiment 131:108. The spinal implant assembly of embodiment 107, wherein the cartridge is reversibly coupled to the spinal implant.

[0374] Embodiment 132: A spinal implant assembly as described in embodiment 108, wherein the locking structure comprises a locking spring finger configured to deform outward on the spinal implant when the cartridge is inserted and configured to return to a predetermined position when the cartridge is fully inserted.

[0375] Embodiment 133: A spinal implant assembly as described in embodiment 108, wherein the locking structure comprises a pin positioned on the spinal implant and a locking ledge positioned on the cartridge, and the pin on the spinal implant is configured to hold the locking ledge to retain the cartridge after insertion.

[0376] Embodiment 134: 134. The spinal implant assembly of embodiment 133, wherein the locking ledge has the radius of the pin.

[0377] Embodiment 135: 109. The spinal implant assembly of embodiment 108, wherein the locking structure comprises a clip or groove positioned along the length of the cartridge, the clip or groove configured to retain the cartridge within the spinal implant.

[0378] Embodiment 136: 108. The spinal implant assembly of embodiment 107, wherein the spinal implant is an interbody spacer or a spinal cage.

[0379] Embodiment 137: 1. An intelligent implant assembly for implantation within a patient, comprising: An implant body, an opening on a first end of the implant body; an implant body comprising: a cavity extending through the implant body from the opening toward a second side of the implant body; a cartridge inserted into the intelligent implant, the cartridge being retained within a cavity of the implant body and within an outer periphery of the implant body, the cartridge including an outer wall configured to house a plurality of components; and a locking structure for securing the spinal implant with the spinal implant.

[0380] Embodiment 138: An intelligent implant assembly as described in embodiment 137, wherein at least one of the left side of the body or the right side of the body includes a plurality of ridges, the plurality of ridges being configured to improve engagement of the spinal implant with adjacent vertebrae.

[0381] Embodiment 139: An intelligent implant assembly as described in embodiment 137, wherein the cartridge includes a power source.

[0382] Embodiment 140: An intelligent implant assembly as described in embodiment 139, wherein the power source is either a single-use or rechargeable battery.

[0383] Embodiment 141: An intelligent implant assembly as described in embodiment 137, wherein the cartridge includes an antenna.

[0384] Embodiment 142: An intelligent implant assembly as described in embodiment 141, wherein the antenna is positioned on a cartridge within the opening of the spinal implant.

[0385] Embodiment 143: An intelligent implant assembly as described in embodiment 141, wherein the antenna is positioned within the outer wall of the cartridge.

[0386] Embodiment 144: An intelligent implant assembly as described in embodiment 141, wherein the antenna is at least one of a loop antenna and a conformal antenna.

[0387] Embodiment 145: An intelligent implant assembly as described in embodiment 141, wherein the antenna continuously transmits sensor data.

[0388] Embodiment 146: An intelligent implant assembly as described in embodiment 141, wherein the antenna transmits sensor data intermittently.

[0389] Embodiment 147: An intelligent implant assembly as described in embodiment 137, wherein the cartridge comprises a processor.

[0390] Embodiment 148: An intelligent implant assembly as described in embodiment 137, wherein the cartridge comprises at least one sensor.

[0391] Embodiment 149: An intelligent implant assembly as described in embodiment 148, wherein at least one sensor is an ultrasonic sensor.

[0392] Embodiment 150: An intelligent implant assembly as described in embodiment 149, wherein the ultrasonic sensor is a low-power sensor.

[0393] Embodiment 151: An intelligent implant assembly as described in embodiment 148, wherein at least one sensor detects one or more physiological parameters continuously or intermittently.

[0394] Embodiment 152: An intelligent implant assembly as described in embodiment 148, wherein the cartridge comprises a memory device for storing data from at least one sensor.

[0395] Embodiment 153: An intelligent implant assembly as described in embodiment 137, wherein the cartridge has a circular, oval, square, or rectangular cross-section and a length.

[0396] Embodiment 154: An intelligent implant assembly as described in embodiment 137, wherein the outer wall has a wall thickness of about 0.5 mm.

[0397] Embodiment 155: An intelligent implant assembly as described in embodiment 137, wherein the outer wall has a wall thickness of less than 1 mm.

[0398] 156. An intelligent implant assembly as described in embodiment 137, wherein the cartridge has a width-to-height ratio of 1:2.

[0399] Embodiment 157: An intelligent implant assembly as described in embodiment 137, wherein the cartridge has a width-to-height ratio of 2:3.

[0400] Embodiment 158: An intelligent implant assembly as described in embodiment 137, wherein the cartridge is reversibly coupled to the spinal implant.

[0401] Embodiment 159: An intelligent implant assembly as described in embodiment 137, wherein the locking structure comprises a locking spring finger configured to deform outward on the spinal implant when the cartridge is inserted and configured to return to a predetermined position when the cartridge is fully inserted.

[0402] Embodiment 160: An intelligent implant assembly as described in embodiment 137, wherein the locking structure comprises a pin positioned on the spinal implant and a locking ledge positioned on the cartridge, and the pin on the spinal implant is configured to hold the locking ledge to retain the cartridge after insertion.

[0403] Embodiment 161: An intelligent implant assembly as described in embodiment 160, wherein the lock ledge has the radius of the pin.

[0404] Embodiment 162: An intelligent implant assembly as described in embodiment 137, wherein the locking structure comprises a clip or groove positioned along the length of the cartridge, the clip or groove configured to retain the cartridge within the spinal implant.

[0405] Embodiment 163: 1. A method for monitoring a patient's recovery after spinal fusion, comprising: providing a spinal implant assembly comprising a spinal implant and a cartridge, the cartridge comprising at least one sensor; collecting, with at least one sensor, data indicative of at least one of fusion, subsidence, or migration of the spinal implant; transmitting the data to a remote location.

[0406] Embodiment 164: The method of embodiment 163, wherein the data includes kinematic measurements of the patient's movement.

[0407] Embodiment 165: 164. The method of any of embodiments 163, wherein the data indicates movement of a spinal implant.

[0408] Embodiment 166: The method of any of embodiments 163, wherein the spinal implant comprises an opening and a cavity at a first end of the spinal implant, the cavity extending through the body from the first end of the spinal implant to the second end of the spinal implant.

[0409] Embodiment 167: 167. The method of embodiment 166, wherein the cartridge is configured to be inserted into the opening of the spinal implant so that the cartridge is secured within the cavity of the spinal implant.

[0410] Embodiment 168: 164. The method of embodiment 163, wherein the cartridge comprises a power source, a memory source, and a processor.

[0411] Embodiment 169: The method of embodiment 163, wherein one of the at least one sensors includes an accelerometer and / or a gyroscope.

[0412] Embodiment 170: The method of embodiment 169, wherein the accelerometer and / or gyroscope are configured to measure at least one of the patient's steps, cadence, walking speed, angle of movement, or gait.

[0413] Embodiment 171: The method of embodiment 163, wherein one of the at least one sensors comprises at least one ultrasonic sensor.

[0414] Embodiment 175: The method of embodiment 171, wherein at least one ultrasonic sensor is configured to detect translation of the spinal implant.

[0415] Embodiment 173: The method of embodiment 172, wherein the translational movement of the spinal implant is configured to measure the movement of the spinal implant from the implantation point in the patient.

[0416] Embodiment 174: The method of embodiment 171, wherein at least one ultrasonic sensor is configured to measure the distance between the surface of the spinal implant and an adjacent vertebra.

[0417] Embodiment 175: 173. The method of embodiment 172, wherein a change in the distance between the surface of the spinal implant and the adjacent vertebrae is configured to measure subsidence of the spinal implant.

[0418] 176. Embodiment 176 The method of embodiment 163, wherein the at least one sensor includes at least one vibration sensor.

[0419] Embodiment 177:The method of embodiment 176, wherein at least one vibration sensor is configured to detect acoustic emissions associated with the spinal implant relative to adjacent vertebrae.

[0420] Embodiment 178: The method of embodiment 177, wherein the acoustic radiation is configured to measure the fusion of the spinal implant to the adjacent vertebrae.

[0421] Embodiment 179: The method of embodiment 163, wherein at least one sensor is configured to calibrate the cartridge when the patient is in a known position.

[0422] Embodiment 180: The method of embodiment 163, wherein the spinal implant is an interbody spacer or a spinal cage.

[0423] Embodiment 181: 1. A method for monitoring a patient's recovery after spinal fusion, comprising: receiving data from the spinal implant assembly; processing the data to assess spinal implant migration, spinal implant subsidence, and / or spinal implant fusion; and providing an output to a clinician based on the processed data.

[0424] Embodiment 182: The method of embodiment 181, wherein the data includes kinematic measurements.

[0425] Embodiment 183: The method of embodiment 181, wherein the patient's kinematic measurements are associated with at least one of the patient's step count, cadence, walking speed, angle of movement, or gait.

[0426] Embodiment 184: The method of embodiment 181, wherein the data includes measurements indicative of movement of the spinal implant.

[0427] Embodiment 185:182. The method of embodiment 181, further comprising determining the movement of the spinal implant based on the translational movement of the spinal implant.

[0428] 186. The method of embodiment 181, wherein the data includes measurements indicative of subsidence of the spinal implant.

[0429] Embodiment 187: 182. The method of 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.

[0430] Embodiment 188: The method of embodiment 181, wherein the data includes measurements indicative of fusion between the spinal implant and adjacent vertebrae.

Claims

1. 1. An implantable sensor assembly for use during spinal fusion, comprising: an implantable prosthesis component; an implantable cartridge associated with said component; The movable cartridge comprises: at least one sensor capable of detecting one or more kinematic measurements associated with the patient and generating sensor data; an antenna in electrical communication with the at least one sensor, the antenna transmitting sensor data to a receiver at a remote location.

2. The implantable sensor assembly of claim 1 , wherein the implantable cartridge further comprises a battery.

3. The implantable sensor assembly of claim 1 , wherein the implantable cartridge further comprises an inertial measurement unit having a plurality of accelerometers and / or a plurality of gyroscopes.

4. The inertial measurement unit a first accelerometer and / or a first gyroscope for measuring data related to a first measurement axis; a second accelerometer and / or a second gyroscope for measuring data related to a second measurement axis; 4. The implantable sensor assembly of claim 3, comprising a third accelerometer and / or a third gyroscope for measuring data related to a third measurement axis.

5. The implantable sensor assembly of claim 1 , wherein the implantable cartridge has a length with a cross section that is circular, oval, square, or rectangular.

6. The implantable sensor assembly of claim 1 , wherein the implantable cartridge has a cross-section with corner radii associated with a square or rectangular cross-section.

7. The implantable sensor assembly of claim 1 , wherein the implantable cartridge is positioned within the component.

8. The implantable sensor assembly of claim 1 , wherein the implantable cartridge is insertable into a slot in the component.

9. The implantable sensor assembly of claim 1 , wherein the implantable cartridge is mechanically coupled to the component.

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

11. The implantable sensor assembly of claim 8 , wherein the implantable cartridge forms a unidirectional positive connection with the component.

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

13. The implantable sensor assembly of claim 8 , wherein the implantable cartridge is press-fit within the component.

14. The implantable sensor assembly of claim 1 , wherein the implantable cartridge comprises a plurality of sensors positioned on a top surface of the implantable cartridge.

15. The implantable sensor assembly of claim 14 , wherein the implantable cartridge comprises a plurality of sensors positioned on a bottom surface of the implantable cartridge.

16. The implantable sensor assembly of claim 15 , wherein the implantable cartridge comprises at least one sensor positioned on a proximal surface of the implantable cartridge.

17. 17. The implantable sensor assembly of claim 16, wherein the implantable cartridge comprises at least one sensor positioned on a distal surface of the implantable cartridge.

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

19. 18. The implantable sensor assembly of claim 17, wherein the at least one sensor positioned on a proximal surface of the implantable cartridge and a distal surface of the implantable cartridge provides movement related to translational direction and orientation of the implantable sensor assembly.

20. The implantable sensor assembly of claim 14 , wherein the plurality of sensors positioned on the top surface of the implantable cartridge are in series.

21. 16. The implantable sensor assembly of claim 15, wherein the plurality of sensors positioned on the bottom surface of the implantable cartridge are in series.

22. 10. The implantable sensor assembly of claim 1, wherein the implantable cartridge comprises a series of three sensors on a top surface of the implantable cartridge, a series of three sensors on a bottom surface of the implantable cartridge, a plurality of sensors on a proximal end of the implantable cartridge, and a plurality of sensors on a distal end of the implantable cartridge.

23. The implantable sensor assembly of claim 1 , wherein the antenna extends from a proximal or distal end of the implantable cartridge.

24. The implantable sensor assembly of claim 1 , wherein the antenna is contained within a gap in the component.

25. 22. The implantable sensor assembly of claim 21, wherein the antenna is contained within the component whose material composition allows for signal transmission from the antenna.

26. 26. The implantable sensor assembly of claim 25, wherein the component comprises PEEK.

27. The implantable sensor assembly of claim 1 , further comprising a processor.

28. The implantable sensor assembly of claim 1 , wherein the implantable prosthesis component is an interbody spacer for use during spinal fusion.

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

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

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

32. The implantable sensor assembly of claim 1 , wherein the at least one sensor is an ultrasound sensor.

33. 33. The implantable sensor assembly of claim 32, wherein the ultrasound sensor is an M-mode sensor.

34. 33. The implantable sensor assembly of claim 32, wherein the ultrasound sensor is a B-mode sensor.

35. 33. The implantable sensor assembly of claim 32, wherein the ultrasonic sensor is a low power sensor.

36. The implantable sensor assembly of claim 1 , wherein the antenna is a loop antenna.

37. The implantable sensor assembly of claim 1 , wherein the antenna is a conformal antenna.

38. The implantable sensor assembly of claim 1 , wherein the antenna transmits sensor data continuously.

39. The implantable sensor assembly of claim 1 , wherein the antenna transmits sensor data intermittently.

40. The implantable sensor assembly of claim 1 , wherein the at least one sensor continuously senses one or more physiological parameters.

41. The implantable sensor assembly of claim 1 , wherein the at least one sensor intermittently senses one or more physiological parameters.

42. The implantable sensor assembly of claim 1 , further comprising a power source for providing power to the at least one sensor.

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

44. The implantable sensor assembly of claim 1 , wherein the at least one sensor is capable of being powered by a power source outside the patient's body.

45. The implantable sensor assembly of claim 1 , further comprising a memory device for storing data from the at least one sensor.

46. The implantable sensor assembly of claim 1 , further comprising a storage device having sufficient memory to allow firmware upgrades of the implantable sensor assembly.

47. 1. A spinal implant assembly for use during spinal fusion, comprising: Interbody spacers and a cartridge mechanically coupled to the interbody spacer; The cartridge comprises: at least one sensor capable of sensing one or more physiological parameters of the patient and generating sensor data; an antenna in electrical communication with the at least one sensor, the antenna providing two-way data communication to a receiver at a remote location; A spinal implant assembly, wherein the cartridge is insertable into a mating female cavity in the interbody spacer.

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

49. 48. The spinal implant assembly of claim 47, wherein the interbody spacer further comprises an inertial measurement unit having a plurality of accelerometers and a plurality of gyroscopes.

50. The inertial measurement unit a first accelerometer and a first gyroscope for measuring data related to a first measurement axis; a second accelerometer and a second gyroscope for measuring data associated with a second measurement axis; 50. The spinal implant assembly of claim 49, comprising a third accelerometer and a third gyroscope for measuring data associated with a third measurement axis.

51. 48. The spinal implant assembly of claim 47, wherein the cartridge has a length with a circular, oval, square, or rectangular cross section.

52. 48. The spinal implant assembly of claim 47, wherein the cartridge cross section has corner radii associated with a square or rectangular cross section.

53. 48. The spinal implant assembly of claim 47, wherein the cartridge is mechanically coupled to the interbody spacer.

54. 48. The spinal implant assembly of claim 47, wherein the cartridge is reversibly coupled to the interbody spacer.

55. 48. The spinal implant assembly of claim 47, wherein the cartridge forms a unidirectional positive connection with the interbody spacer.

56. 48. The spinal implant assembly of claim 47, wherein the cartridge is mechanically coupled to the interbody spacer using at least one of a corresponding snap ring, lock, twist, torsion, or chemical adhesive.

57. 48. The spinal implant assembly of claim 47, wherein the cartridge is press-fit into the interbody spacer.

58. 48. The spinal implant assembly of claim 47, wherein the cartridge comprises a plurality of sensors positioned on a top surface of the cartridge.

59. 60. The spinal implant assembly of claim 58, wherein the cartridge comprises a plurality of sensors positioned on a bottom surface of the cartridge.

60. 60. The spinal implant assembly of claim 59, wherein the cartridge comprises at least one sensor positioned on a proximal surface of the cartridge.

61. 61. The spinal implant assembly of claim 60, wherein the cartridge comprises at least one sensor positioned on a distal surface of the cartridge.

62. 60. The spinal implant assembly of claim 59, wherein the plurality of sensors positioned on the top surface of the cartridge and the plurality of sensors positioned on the bottom surface of the cartridge are configured to measure subsidence of the interbody spacer.

63. 62. The spinal implant assembly of claim 61, wherein the at least one sensor positioned on a proximal surface of the cartridge and a distal surface of the cartridge provides movement related to translation and orientation of the interbody spacer.

64. 59. The spinal implant assembly of claim 58, wherein the plurality of sensors positioned on the top surface of the cartridge are in series.

65. 60. The spinal implant assembly of claim 59, wherein the plurality of sensors positioned on the bottom surface of the cartridge are in series.

66. 48. The spinal implant assembly of claim 47, wherein the cartridge comprises a series of three sensors on a top surface of the cartridge, a series of three sensors on a bottom surface of the cartridge, a plurality of sensors on a proximal end of the cartridge, and a plurality of sensors on a distal end of the cartridge.

67. 48. The spinal implant assembly of claim 47, wherein the antenna extends from a proximal or distal end of the cartridge.

68. 48. The spinal implant assembly of claim 47, further comprising a processor.

69. 48. The spinal implant assembly of claim 47, wherein the interbody spacer is inserted into a portion of the patient's lumbar spine.

70. 48. The spinal implant assembly of claim 47, wherein the spinal cage interbody spacer is inserted into a portion of the patient's cervical spine.

71. 48. The spinal implant assembly of claim 47, wherein the interbody spacer is inserted into a portion of the patient's thoracic spine.

72. 48. The spinal implant assembly of claim 47, wherein the at least one sensor is an ultrasonic sensor.

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

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

75. 73. The spinal implant assembly of claim 72, wherein the ultrasonic sensor is a low power sensor.

76. 48. The spinal implant assembly of claim 47, wherein the antenna is a loop antenna.

77. 48. The spinal implant assembly of claim 47, wherein the antenna is a conformal antenna.

78. 48. The spinal implant assembly of claim 47, wherein the antenna transmits sensor data continuously.

79. 48. The spinal implant assembly of claim 47, wherein the antenna transmits sensor data intermittently.

80. 48. The spinal implant assembly of claim 47, wherein the at least one sensor continuously detects one or more physiological parameters.

81. 48. The spinal implant assembly of claim 47, wherein the at least one sensor intermittently detects one or more physiological parameters.

82. 48. The spinal implant assembly of claim 47, further comprising a power source for providing power to the at least one sensor.

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

84. 48. The spinal implant assembly of claim 47, wherein the at least one sensor is powerable by a power source outside the patient's body.

85. 48. The spinal implant assembly of claim 47, further comprising a memory device for storing data from the at least one sensor.

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

87. 87. The method of claim 86, wherein the detection of one or more kinematic measurements occurs during movement of the patient.

88. 87. The method of claim 86, wherein detecting one or more kinematic measurements occurs and the interbody spacer is under load.

89. 87. The method of claim 86, wherein the method further comprises calibrating the implantable cartridge when the patient is in a known position.

90. 90. The method of claim 89, wherein the known position is when the patient is lying down.

91. 90. The method of claim 89, wherein the known position is when the patient is standing against a wall.

92. 90. The method of claim 89, wherein the known position is when the patient's back is at a predetermined angle while the patient is in a sitting position.

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

94. 88. The method of claim 87, wherein the one or more kinematic measurements are used to determine fusion of the interbody spacer.

95. 88. The method of claim 87, wherein the one or more kinematic measurements are used to determine subsidence of the interbody spacer.

96. 96. The method of claim 95, wherein the subsidence measures the amount of force exerted by vertebrae adjacent the interbody spacer.

97. 88. The method of claim 87, wherein the one or more kinematic measurements are used to determine movement of the interbody spacer.

98. 98. The method of claim 97, wherein the movement measures translation of the interbody spacer at the point of implantation.

99. 87. The method of claim 86, wherein the movement measures a change in the kinematics of the interbody spacer at the point of implantation.

100. 87. The method of claim 86, wherein the one or more kinematic measurements are used to determine patient movement.

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

102. 87. The method of claim 86, further comprising determining how quickly the patient returns to normal activity.

103. said implantable cartridge comprising: at least one sensor capable of detecting one or more kinematic measurements associated with the patient and generating sensor data; 87. The method of claim 86, comprising: an antenna in electrical communication with the at least one sensor, the antenna transmitting sensor data to a receiver at a remote location and receiving data from the receiver.

104. 102. The method of claim 101, wherein the implantable cartridge further comprises a battery.

105. 87. The method of claim 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.

106. measuring data related to a first measurement axis, the data related to the first measurement axis being obtained from a first accelerometer and a first gyroscope of the inertial measurement unit; measuring data related to a second measurement axis, the data related to the second measurement axis being obtained from a second accelerometer and a second gyroscope of the inertial measurement unit; 106. The method of claim 105, comprising measuring data related to a third measurement axis, the data related to the third measurement axis being obtained from a third accelerometer and a third gyroscope of the inertial measurement unit.

107. 1. A spinal implant assembly for use during spinal fusion, comprising: a spinal implant, the spinal implant comprising: The main body and an opening on a first end of the body; a cavity extending through the body of the spinal implant from the opening toward a second end of the body; a cartridge configured to be inserted into the cavity, the cartridge comprising an outer wall configured to house a plurality of components;

108. 108. The spinal implant assembly of claim 107, further comprising a locking structure for securing the spinal implant with the cartridge.

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

110. 108. The spinal implant assembly of claim 107, further comprising a hole extending from a top surface of the body to a bottom surface of the body, the hole in the spinal implant configured to be filled with a biological or synthetic material to assist in spinal fusion.

111. 108. The spinal implant assembly of claim 107, wherein the cartridge includes a power source.

112. 112. The spinal implant assembly of claim 111, wherein the power source is either a single use or a rechargeable battery.

113. 108. The spinal implant assembly of claim 107, wherein the cartridge includes an antenna.

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

115. 114. The spinal implant assembly of claim 113, wherein the antenna is positioned within the outer wall of the cartridge.

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

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

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

119. 108. The spinal implant assembly of claim 107, wherein the cartridge comprises a processor.

120. 108. The spinal implant assembly of claim 107, wherein the cartridge comprises at least one sensor.

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

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

123. 121. The spinal implant assembly of claim 120, wherein the at least one sensor detects one or more physiological parameters continuously or intermittently.

124. 121. The spinal implant assembly of claim 120, wherein the cartridge comprises a memory device for storing data from the at least one sensor.

125. 108. The spinal implant assembly of claim 107, wherein the cartridge has a length with a circular, oval, square, or rectangular cross section.

126. 108. The spinal implant assembly of claim 107, wherein the outer wall has a wall thickness of about 0.5 mm.

127. 108. The spinal implant assembly of claim 107, wherein the outer wall has a wall thickness of less than 1 mm.

128. 108. The spinal implant assembly of claim 107, wherein the cartridge has a width to height ratio of 1:

2.

129. 108. The spinal implant assembly of claim 107, wherein the cartridge has a width to height ratio of 2:

3.

130. 108. The spinal implant assembly of claim 107, wherein the cartridge has a width of 8 mm, a thickness of 4 mm, and a length of 28 mm.

131. 108. The spinal implant assembly of claim 107, wherein the cartridge is reversibly coupled to the spinal implant.

132. 109. The spinal implant assembly of claim 108, wherein the locking structure comprises locking spring fingers configured to deform outwardly on the spinal implant when the cartridge is inserted and configured to return to a predetermined position when the cartridge is fully inserted.

133. 109. The spinal implant assembly of claim 108, wherein the locking structure comprises a pin positioned on the spinal implant and a locking ledge positioned on the cartridge, the pin on the spinal implant configured to hold the locking ledge to retain the cartridge after insertion.

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

135. 109. The spinal implant assembly of claim 108, wherein the locking structure comprises a clip or groove positioned along a length of the cartridge, the clip or groove configured to retain the cartridge within the spinal implant.

136. 108. The spinal implant assembly of claim 107, wherein the spinal implant is an interbody spacer or a spinal cage.

137. 1. An intelligent implant assembly for implantation within a patient, comprising: an implant body, the implant body comprising: an opening on a first end of the implant body; a cavity extending through the implant body from the opening toward a second side of the implant body; a cartridge inserted into the intelligent implant, the cartridge being retained within the cavity of the implant body and within an outer periphery of the implant body, the cartridge including an outer wall configured to house a plurality of components; and a locking structure for securing the spinal implant with the spinal implant.

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

139. The intelligent implant assembly of claim 137, wherein the cartridge includes a power source.

140. 140. The intelligent implant assembly of claim 139, wherein the power source is either a single use or a rechargeable battery.

141. The intelligent implant assembly of claim 137, wherein the cartridge includes an antenna.

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

143. 142. The intelligent implant assembly of claim 141, wherein the antenna is positioned within the outer wall of the cartridge.

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

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

146. 142. The intelligent implant assembly of claim 141, wherein the antenna transmits sensor data intermittently.

147. The intelligent implant assembly of claim 137, wherein the cartridge comprises a processor.

148. The intelligent implant assembly of claim 137, wherein the cartridge comprises at least one sensor.

149. The intelligent implant assembly of claim 148, wherein the at least one sensor is an ultrasonic sensor.

150. 150. The intelligent implant assembly of claim 149, wherein the ultrasonic sensor is a low power sensor.

151. 149. The intelligent implant assembly of claim 148, wherein the at least one sensor detects one or more physiological parameters continuously or intermittently.

152. 149. The intelligent implant assembly of claim 148, wherein the cartridge comprises a memory device for storing data from the at least one sensor.

153. 138. The intelligent implant assembly of claim 137, wherein the cartridge has a length with a circular, oval, square, or rectangular cross section.

154. 138. The intelligent implant assembly of claim 137, wherein the outer wall has a wall thickness of about 0.5 mm.

155. 138. The intelligent implant assembly of claim 137, wherein the outer wall has a wall thickness of less than 1 mm.

156. 138. The intelligent implant assembly of claim 137, wherein the cartridge has a width-to-height ratio of 1:

2.

157. 138. The intelligent implant assembly of claim 137, wherein the cartridge has a width to height ratio of 2:

3.

158. 138. The intelligent implant assembly of claim 137, wherein the cartridge is reversibly coupled to the spinal implant.

159. 138. The intelligent implant assembly of claim 137, wherein the locking structure comprises locking spring fingers configured to deform outward on the spinal implant when the cartridge is inserted and configured to return to a predetermined position when the cartridge is fully inserted.

160. 138. The intelligent implant assembly of claim 137, wherein the locking structure comprises a pin positioned on the spinal implant and a locking ledge positioned on the cartridge, the pin on the spinal implant configured to hold the locking ledge to retain the cartridge after insertion.

161. 161. The intelligent implant assembly of claim 160, wherein the locking ledge has a radius of the pin.

162. 138. The intelligent implant assembly of claim 137, wherein the locking structure comprises a clip or groove positioned along the length of the cartridge, the clip or groove configured to retain the cartridge within the spinal implant.

163. 1. A method for monitoring a patient's recovery after spinal fusion, said method comprising: providing a spinal implant assembly comprising a spinal implant and a cartridge, the cartridge comprising at least one sensor; collecting, with the at least one sensor, data indicative of at least one of fusion, subsidence, or migration of the spinal implant; transmitting the data to a remote location.

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

165. 164. The method of claim 163, wherein the data indicates movement of the spinal implant.

166. 164. The method of claim 163, wherein the spinal implant includes an opening on a first end of the spinal implant and a cavity, the cavity extending through the body from the first end of the spinal implant to a second end of the spinal implant.

167. 167. The method of claim 166, wherein the cartridge is configured to be inserted into the opening in the spinal implant such that the cartridge is secured within the cavity in the spinal implant.

168. 164. The method of claim 163, wherein the cartridge comprises a power source, a memory source, and a processor.

169. 46. ​​The method of claim 45, wherein one of the at least one sensor comprises an accelerometer and / or a gyroscope.

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

171. 164. The method of claim 163, wherein one of the at least one sensors comprises at least one ultrasonic sensor.

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

173. 173. The method of claim 172, wherein the translational movement of the spinal implant is configured to measure movement of the spinal implant from a point of implantation in a patient.

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

175. 173. The method of claim 172, wherein a change in distance between the surface of the spinal implant and the adjacent vertebrae is configured to measure subsidence of the spinal implant.

176. 164. The method of claim 163, wherein the at least one sensor includes at least one vibration sensor.

177. 177. The method of claim 176, wherein the at least one vibration sensor is configured to detect acoustic emissions associated with the spinal implant relative to adjacent vertebrae.

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

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

180. 164. The method of claim 163, wherein the spinal implant is an interbody spacer or a spinal cage.

181. 1. A method for monitoring a patient's recovery after spinal fusion, comprising: receiving data from the spinal implant assembly; processing the data to assess 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. 182. The method of claim 181, wherein the data includes kinematic measurements.

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

184. 182. The method of claim 181, wherein the data includes measurements indicative of movement of the spinal implant.

185. 182. The method of claim 181, further comprising determining a movement of the spinal implant based on the translation of the spinal implant.

186. 182. The method of claim 181, wherein the data includes measurements indicative of subsidence of the spinal implant.

187. 182. The method of claim 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.

188. 182. The method of claim 181, wherein the data includes measurements indicative of fusion between the spinal implant and adjacent vertebrae.

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