Internal sensor system for monitoring movement of a host

Abstract

A cartridge may be secured to or near a bone of a patient, e.g., a tibia, optionally via a securing structure such as a threaded screw. In one aspect, a cartridge includes an electronics assembly, a housing enclosing the electronics assembly, and a cartridge coupling feature configured to couple to the securing structure. The electronics assembly includes at least one sensor and a controller having a joint-specific modules. A joint-specific module is configured to collect kinematic data resulting from movement of a specific joint sensed by the at least one sensor. In another aspect, a cartridge includes an electronics assembly comprising at least one sensor and a housing enclosing the electronics assembly. The cartridge has a form factor that is configured to be at least partially inserted into a receptacle in a bone of a patient.

Description

INTERNAL SENSOR SYSTEM FOR MONITORING MOVEMENT OF A HOSTCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] All applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference.BACKGROUNDField

[0002] The present disclosure relates generally to implantable sensor-containing devices such as orthopedic implants, and more particularly, to a smart implant configured to be secured at a location within a host, such as directly or indirectly to a bone, to monitor the movement of the host.Description of the Related Art

[0003] Anterior cruciate ligament (ACL) tears are one of the most common sports injuries in the United States. Some common surgical procedures to repair a torn or damaged ACL are ACL reconstruction (ACL-R) or ACL repair. The ACL-R procedure typically involves implanting a graft in place of the torn ACL to restore knee function and stability. However, the surgery comes with many complication risks such as arthrofibrosis, graft failure, and infection that may drastically change patient outcomes and the need for a revision surgery. Revision ACL-R is a complex and technically challenging procedure that often leads to inferior clinical outcomes when compared to primary ACL-R. Thus, it is important for clinicians to identify, address, and avoid the complications associated with ACL-R. Another ACL surgery option is ACL repair, which involves suturing or anchoring the existing torn ACL tissue, rather than replacing it with a graft.

[0004] Postoperative radiographs or MRIs after ACL surgery are some way to monitor the progress of the recovery. However, the images may not reveal much meaningful information about the recovery progress of the ACL surgery. Physicians may also perform in-person physical exams to assess the stability and strength of the knee throughout recovery. However, the physician may not be able to accurately assess the reasons for any problems arising during recovery, as patients may be reluctant or forgetful when disclosing the full scope of their activities during recovery. Recovery from joint repair surgery, such as ACL-R, may span over a time up to 12 months, and patients and physicians would benefit from consistent devices ormethods for collecting data from a patient throughout the recovery period to monitor recovery progress.SUMMARY

[0005] Briefly stated, the present disclosure addresses an unmet need recognized by the inventors, for a device that may be implanted into a host to monitor movement of the host and thereby characterize the physiological status of the host over time. For example, to monitor the recovery of a patient that has undergone joint repair surgery, e.g., ACL repair or ACL reconstruction by obtaining kinematic data that can be used to characterize the hosts' movement, such as the host's gait during ambulation, over time.

[0006] In one aspect, the present disclosure makes use of a smart cartridge that may be secured to a bone, where the bone has undergone an ACL repair, e.g., the cartridge may be secured to the tibia. In one aspect, the smart cartridge includes an electronics assembly, a housing enclosing the electronics assembly, and a cartridge coupling feature configured to couple the cartridge to a threaded insert. The threaded insert is inserted into a hole, also referred to as a receptacle, that the surgeon drills into the tibia, in the vicinity of an ACL repair screw. The electronics assembly includes at least one sensor and a controller having at least one joint-specific module. Each joint-specific module is configured to collect kinematic data resulting from movement of a joint, e.g., a knee joint, to which the cartridge is secured via an adjacent bone, e.g. a tibia when the joint is a knee. The cartridge may be referred to as a universal cartridge in that it is designed to secure to more than one specific bone, e.g., a tibia or a femur.

[0007] In another aspect, a cartridge includes an electronics assembly comprising at least one sensor and a housing enclosing the electronics assembly. The cartridge has a form factor that is configured to be at least partially inserted into a cartridge receptacle in a bone, where the cartridge receptable may be a hollow cavity resulting from the surgeon drilling the cavity into the bone, e.g., into the tibia. The sensor may be, e.g., an accelerometer, a gyroscope, two accelerometers, an accelerometer and a gyroscope, or two accelerometers and a gyroscope, to name a few possibilities.

[0008] In another aspect, a cartridge includes a housing, at least one sensor aligned within the housing relative to an axis of a coordinate system of the cartridge to sense movement relative to the axis, and a alignment feature. The smart cartridge has a form factor that is configured to be at least partially inserted into a receptacle of a bone.

[0009] The present disclosure also relates to cartridges configured to extend at least partially into a cavity of a bone of a body. In one aspect, the cartridge has an electronics assembly comprising at least one sensor, and a controller having at least one joint-specific module, where a joint-specific module is configured to collect kinematic data resulting from movement of a specific joint, for example, a knee, as sensed by the at least one sensor.

[0010] The present disclosure also relates to intelligent implants that include a threaded insert and a smart cartridge. The bone has been modified to include a receptacle configured to receive the threaded insert, and the smart cartridge may be secured to the threaded insert in order to secure the smart cartridge to the bone. The smart cartridge has a form factor that is configured to be at least partially inserted into the receptacle of the bone, including the pre-positioning of the threaded insert. In one aspect, the smart cartridge includes an electronics assembly and a housing enclosing the electronics assembly. The electronics assembly includes at least one sensor, and a controller having at least one joint-specific module, where the joint-specific module is configured to collect kinematic data resulting from movement of a joint of interest, e.g., the knee, as sensed by the at least one sensor.

[0011] The present disclosure also relates to a smart cartridge for subcutaneous implantation into a host, comprising: an electronics assembly comprising a sensor, and a controller having a data-collection module, the data-collection module configured to collect kinematic data sensed by the sensor, where the data characterizes a movement of the host; and a housing enclosing the electronics assembly; wherein the smart cartridge is configured to be subcutaneously implanted at a location within the host. In optional embodiments, the host is a human, the location is adjacent to a bone, optionally where the bone is a spinal bone such as a cervical, thoracic, lumbar, sacrum and coccyx bone; the location is adjacent to a natural joint of a body of the host such as an ankle, a knee, a hip, a wrist, an elbow, and a shoulder, the location is distal to a proximal tibiofibular joint of a leg; the location is at least partially in an anterior compartment of a leg; or the location is at least partially in a posterior compartment of a leg. The movement may be that of a specific joint of the host. The data- collection module may be a joint-specific module, such as a knee-specific or spine-specific module. The smart cartridge may include an electronics assembly comprising a sensor, and a controller having a joint-specific module, the joint-specific module configured to collect kinematic data resulting from movement of a specific joint sensed by the at least one sensor; and a housing enclosing the electronics assembly; wherein the smart cartridge is configuredto be subcutaneously implanted adjacent to a natural joint of a body of the host. The data- collection module may be a joint-specific module comprising a knee module configured to collect kinematic data resulting from movement of a knee sensed by the at least one sensor. When the data pertain to movement of the knee, the kinematic data may be indicative of, for example, a laxity of the knee or a flexion and / or extension of the knee. For purposes of subcutaneous placement, the housing preferably has no sharp features that could damage tissue in contact with the implanted smart cartridge; the housing may comprise exclusively biocompatible materials that will not harm tissue in contact with the implanted smart cartridge; the housing may comprise a biocompatible material selected from metal, silicone and parylene; the housing may comprise a metal which covers the sensor and the controller, and a plastic or ceramic which covers an antenna. Optionally, the smart cartridge is a standalone device and the housing does not include a feature or mechanism for securing the smart cartridge to a bone of the body and / or the housing is not configured to be secured to or otherwise physically associated with a medical implant or prosthesis (such as an artificial total or partial knee replacement, a hip replacement or a shoulder replacement) located within the body; the housing is not configured to be secured to or otherwise directly associated with a bone of the host but instead is inserted into tissue, e.g., muscle tissue. The housing may include a securing mechanism to maintain a position of the cartridge when subcutaneously implanted in tissue such as muscle, where the securing mechanism functions only to maintain a position of the cartridge in the host when it is subcutaneously implanted in the host in tissue.

[0012] The present disclosure also related to a method of monitoring a movement of a host, the method comprising: selecting a host having a smart cartridge implanted at a location in the host, wherein the smart cartridge comprises an electronics assembly comprising a sensor and a controller having a data-collection module, where the data-collection module configured to collect kinematic data generated by the sensor, where the data characterizes a movement of the host, the smart cartridge further comprising a housing enclosing the electronics assembly; sensing the movement of the host with the sensor to generate kinematic data, where the kinematic data provides a characterization of the movement of the host; collecting the kinematic data in a memory enclosed by the housing to provide collected kinematic data; providing transmitted data by way of transmitting the collected kinematic data to a location outside of the housing and / or analyzing the collected kinematic data within the housing to provide movement information and transmitting the movement informationto a location outside of the housing; and analyzing the transmitted data to provide a characterization of the movement of the host. Optionally in the method, one or more of the following exemplary feature may further described the method: the host is a human; the host has a partial or total artificial joint; the host has an ACL injury and / or has had ACL surgery; the host has an abnormal gait; the host has a neurological disorder selected from Parkinson's disease, Alzheimer's disease, Huntington's Disease, cerebellar ataxia, multiple sclerosis, peripheral neuropathy, myelopathy, or a neurological disorder brought on by a stroke or a spinal cord injury; the host has an implanted smart cartridge secured directly to a bone of the host, e.g., the host has an implanted smart cartridge secured directly to a threaded insert, where the threaded insert is secured directly to the bone, the smart cartridge is located in a receptacle of the bone, the smart cartridge is located in a receptacle that has been formed in the exterior of the bone, the smart cartridge is located in a receptacle of a bone and extends partially out of the receptacle when implanted into the receptacle, the smart cartridge comprises a securing feature, wherein the smart cartridge and securing feature are inserted into a receptacle of a bone such that the smart cartridge couples to the securing feature to secure the smart cartridge in the receptacle, the housing of the smart cartridge comprises a surface feature that enables the smart cartridge to associate with a receptacle in a bone to secure the smart cartridge in the receptacle, the smart cartridge is located in a receptacle of a bone and wherein the implanted smart cartridge secures a tensioned element used for the ACL surgery within the receptacle, the smart cartridge is located in a receptacle of a bone and wherein the implanted smart cartridge secures a tensioned element used for the ACL surgery within the receptacle; and wherein the receptacle is a through hole formed in the tibia and is configured to receive the tensioned element comprising an ACL graft, the smart cartridge is located in a receptacle of the bone and wherein the implanted smart cartridge secures a tensioned element used for the ACL surgery within the receptacle; and wherein the receptacle is formed in the tibia and is configured to receive the tensioned element comprising a rope or a suture. Rather then be physically attached to a bone, the smart cartridge may be located subcutaneously adjacent to a bone, where optionally the bone is associated with a joint that has had or will have, an ACL surgery. The smart cartridge may be located subcutaneously adjacent to a bone; wherein the smart cartridge is implanted distal to a proximal tibiofibular joint of a leg. The smart cartridge may be located subcutaneously adjacent to a bone; wherein the smart cartridge is at least partially covered by a securing liner.The location of the smart cartridge may be a leg of the host, such as on or near a tibia of the host, or otherwise on or adjacent to a joint of the host. The kinematic data obtained from the method may be indicative of a laxity, a flexion, and / or an extension of a knee of the host. The kinematic data obtained from the method may indicate that the host walks with an abnormal gait, and may characterize the abnormality to suggest the underlying cause of the abnormal gait.

[0013] This Summary has been provided to introduce certain concepts in a simplified form that are further described in detail below in the Detailed Description. Except where otherwise expressly stated, this Summary is not intended to identify key or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter.BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Exemplary features of the present disclosure, its nature and various advantages will be apparent from the accompanying drawings and the following detailed description of various embodiments. Non-limiting and non-exhaustive embodiments are described with reference to the accompanying drawings, wherein like labels or reference numbers refer to like parts throughout the various views unless otherwise specified. The sizes and relative positions of elements in the drawings are not necessarily drawn to scale. For example, the shapes of various elements are selected, enlarged, and positioned to improve drawing legibility. The particular shapes of the elements as drawn have been selected for ease of recognition in the drawings. One or more embodiments are described hereinafter with reference to the accompanying drawings in which:

[0015] FIGS. 1A and IB are side-view and top-view illustrations of an embodiment of a smart cartridge.

[0016] FIG. 1C is an exploded view of the smart cartridge of FIGS. 1A and IB.

[0017] FIG. 2A and 2B are detailed illustrations of an embodiment of a securing feature and an alignment feature of the smart cartridge of FIGS. 1A and IB.

[0018] FIG. 3 is an illustration of a smart cartridge with an associated threaded insert implanted into the proximal tibia distal to an ACL button, according to embodiments.

[0019] FIGS. 4A and 4B illustrate a perspective view and cross-sectional view of the threaded insert shown in FIG. 3.

[0020] FIG. 4C illustrates two embodiments of the smart cartridge shown in FIG. 3 with different dimensions.

[0021] FIG. 5 is an illustration of a smart cartridge without an associated threaded insert, wherein the smart cartridge is implanted into the proximal tibia distal to an ACL button, according to embodiments.

[0022] FIG. 6 illustrates two embodiments of the smart cartridge shown in FIG. 5 with different dimensions.

[0023] FIG. 7 is an illustration of a smart cartridge, wherein the smart cartridge is implanted into the proximal tibia distal to the ACL button, with the antenna residing within cancellous bone, according to embodiments.

[0024] FIG. 8A and FIG. 8B illustrate two embodiments of the smart cartridge shown in FIG. 7 with different dimensions.

[0025] FIG. 9A is a block diagram of the electronics of a smart cartridge.

[0026] FIG. 9B is a perspective view of an inertial measurement unit (IMU) of the electronics of the smart cartridge FIG. 9A and of a set of coordinate axes within the frame of reference of the IMU.

[0027] FIG. 9C is an illustration of a set of coordinate axes of an IMU of a smart cartridge relative to a patient in which the host has received a smart cartridge adjacent to the knee joint, e.g., the tibia.

[0028] FIG. 9D is an illustration of a set of coordinate axes of an IMU of a smart cartridge relative to a patient in which a host has received a smart cartridge adjacent to their shoulder joint.

[0029] FIG. 9E is an illustration of a set of coordinate axes of an IMU of a smart cartridge relative to a patient in which a host has received a smart cartridge adjacent to the hip joint.

[0030] FIG. 10 is a context diagram of a smart cartridge, secured to a patient, in a patient's home.

[0031] FIG. 11 is an illustration of a smart cartridge implanted into a through hole having an ACL graft for an ACL reconstruction surgery, according to embodiments.

[0032] FIG. 12 is an illustration of a smart cartridge implanted in the proximal tibia distal to an ACL button with a rope used for an ACL surgery, according to embodiments.

[0033] FIG. 13 is an illustration of a smart cartridge implanted in the proximal tibia distal to an ACL button and having a plate portion extending out of the tibia, according to embodiments.

[0034] FIG. 14 is an illustration of a smart cartridge having a capsule shape, according toembodiments, which may be used for subcutaneous insertion into a subcutaneous implantation zone.

[0035] FIG. 15 is an illustration of a subcutaneous implantation zone near the tibia for implantation of a smart cartridge to monitor an ACL surgery, according to embodiments.

[0036] FIG. 16 is an illustration of a delivery device used for subcutaneously implanting a smart cartridge, according to embodiments.

[0037] FIG. 17 is an illustration of the steps for operating the delivery device shown in FIG. 16.

[0038] FIG. 18 is an illustration of subcutaneous implantation zones for a smart cartridge to monitor an ACL surgery, according to embodiments.DETAILED DESCRIPTION

[0039] The present disclosure may be understood more readily by reference to the following detailed description of preferred embodiments of the disclosure and the examples of smart cartridge configured for integration with each of a number of different types of host bones associated with a joint. The following description, along with the accompanying drawings, sets forth certain specific details in order to provide a thorough understanding of various disclosed embodiments. However, one skilled in the relevant art will recognize that the disclosed embodiments may be practiced in various combinations, without one or more of these specific details, or with other methods, components, devices, etc.

[0040] Prior to setting forth this disclosure in more detail, it may be helpful to an understanding thereof to provide definitions of certain terms to be used herein. Additional definitions are set forth throughout this disclosure. The terms "include" and "comprise," as well as derivatives thereof, mean inclusion without limitation. The term "or," is inclusive, meaning and / or. The phrases "associated with" and "associated therewith," as well as derivatives thereof, may mean to include, be included within, interconnect with, contain, be contained within, connect to or with, couple to or with, be communicable with, cooperate with, interleave, juxtapose, be proximate to, be bound to or with, have, have a property of, or the like. The term "controller" means any device, system, or part thereof that controls at least one operation, such a device may be implemented in hardware (e.g., electronic circuitry), firmware, or software, or some combination of at least two of the same. The functionality associated with any particular controller may be centralized or distributed, whether locally or remotely. Other definitions of certain words and phrases may be providedwithin this patent document. Those of ordinary skill in the art will understand that in many, if not most instances, such definitions apply to prior as well as future uses of such defined words and phrases

[0041] An "implantable medical device" (IMD) as used in the present disclosure, may be an implantable or implanted medical device that replaces, structurally supplements, or functionally supplements a natural body part. For example, an implantable medical device may be an orthopedic implant or a spinal implant.

[0042] A "smart cartridge", also referred to herein as a cartridge, a universal cartridge, or a medical device, as used in the present disclosure, is a component that is configured to monitor and report the status and / or activities of the cartridge and accordingly the status and / or activities of a bone to which, or near which, the cartridge is secured, to provide information as to the status and / or activities of an associated joint, such as a characterization of the movement of the joint. For example, the bone may be a tibia, and the associated joint may be a knee, in which case the information may include a characterization of the movement of the bone and / or joint, which may describe the gait of the host during ambulation. The smart cartridge may be secured directly to a bone or it may be secured indirectly to the bone through an intermediate securing device such as a threaded insert as described herein. The smart cartridge may optionally not be secured directly or indirectly to a bone but instead may be subcutaneously inserted into the host at a location within tissue that is sufficiently near a bone or joint of interest that the smart cartridge moves in effectively the same manner as though it were secured directly to the bone. The smart cartridge may be integrated with or associated with each of a number of different patient bones. The smart cartridge may be integrated with or associated with each of a number of different implantable medical devices while being integrated with a bone. The smart cartridge may include electronics that are configured to perform one or more of the following exemplary actions in order to characterize the post-implantation status of the joint: identifying the cartridge, e.g., by recognizing one or more unique identification codes for the cartridge; detecting, sensing and / or measuring parameters, which may collectively be referred to as monitoring parameters, in order to collect operational, kinematic, or other data about the implanted cartridge, wherein such data may optionally be collected as a function of time; storing the collected data within the cartridge; and communicating the collected data and / or the stored data by a wireless means from the implanted cartridge to an external computing device.

[0043] An "intelligent implant" as used in the present disclosure, may refer to an implantable medical device comprising a smart cartridge, and is interchangeably referred to a smart device. When the intelligent implant collects kinematic data (described below), it may be referred to as a kinematic implantable device. The intelligent implant may refer to an implantable medical device integrated with a smart cartridge. In some embodiments, the intelligent implant may referto an implantable smart cartridge which has not been integrated with any separate device.

[0044] The intelligent implant may perform one or more of the following exemplary actions in order to characterize the post-implantation status of the intelligent implant: identifying the intelligent implant or a portion of the intelligent implant, e.g., by recognizing one or more unique identification codes for the intelligent implant or a portion of the intelligent implant; detecting, sensing and / or measuring parameters, which may collectively be referred to as monitoring parameters, in order to collect operational, kinematic, or other data about the intelligent implant or a portion of the intelligent implant and wherein such data may optionally be collected as a function of time; storing the collected data within the intelligent implant or a portion of the intelligent implant; and communicating the collected data and / or the stored data by a wireless means from the intelligent implant or a portion of the intelligent implant to an external computing device. The external computing device may have or otherwise have access to at least one data storage location such as found on a personal computer, a base station, a computer network, a cloud-based storage system, or another computing device that has access to such storage.

[0045] Kinematic data, as used herein, individually, or collectively includes some or all data associated with a particular kinematic implantable device and available for communication outside of the particular kinematic implantable device. For example, kinematic data may include raw data from one or more sensors of a kinematic implantable device, wherein the one or more sensors include such as gyroscopes, accelerometers, pedometers, strain gauges, and the like that produce data associated with motion, force, tension, velocity, or other mechanical forces. Kinematic data may also include processed data from one or more sensors, status data, operational data, control data, fault data, time data, scheduled data, event data, log data, and the like associated with the particular kinematic implantable device. In some cases, high resolution kinematic data includes kinematic data from one, many, or all of the sensors of the kinematic implantable device that is collected in higher quantities, resolution,from more sensors, more frequently, or the like.

[0046] Subcutaneous as used in the present disclosure refers to a location beneath the skin of a host, e.g., under the skin of a person. In some medical contexts, the term subcutaneous is used more narrowly to describe injections or administration of medications that are given into the fatty tissue just under the skin. However, as used herein, subcutaneous is used in the broader sense to refer to a location at some distance beneath the skin of a host, not necessarily directly below the skin. For example, an intramuscular location is a subcutaneous location. When a smart cartridge of the present disclosure is implanted at a location, it may be implanted subcutaneously, which refers a method that includes making a small incision through the skin, and cutting into layers below the skin as needed, such as the hypodermis layer, and then inserting the smart cartridge through the incision with the aid of a delivery device, where the delivery device can be used to reach the desired location and deliver the smart cartridge to that location. When the smart cartridge is implanted subcutaneously, the smart cartridge does not contact blood. The subcutaneous insertion may also include marking an initial location on the skin of the host, e.g., on the skin of the leg., where the incision will be made. Subcutaneously inserting the cartridge may include depositing the smart cartridge within or between muscle, i.e., subcutaneous insertion may achieve intramuscular placement of the smart cartridge. In one embodiment the smart cartridge is located intramuscularly by way of subcutaneously inserting the smart cartridge into the muscle.

[0047] In one embodiment, kinematics refers to the measurement of the positions, angles, velocities, and accelerations of body segments and joints during motion. Body segments are considered to be rigid bodies for the purposes of describing the motion of the body. They include the foot, shank (leg), thigh, pelvis, thorax, hand, forearm, upper-arm, and head. Joints between adjacent segments include the ankle (talocrural plus subtalar joints), knee, hip, wrist, elbow, and shoulder. Position describes the location of a body segment or joint in space, measured in terms of distance, e.g., in meters. A related measurement called displacement refers to the position with respect to a starting position. In two dimensions, the position is given in Cartesian co-ordinates, with horizontal followed by vertical position. In one embodiment, a kinematic implant or intelligent kinematic implants obtain kinematic data, and optionally only obtains kinematic data.

[0048] A "sensor" refers to a device that can be utilized to do one or more of detect, measure and / or monitor one or more different aspects of a body (anatomy, physiology, metabolism,movement, and / or function) and / or one or more aspects of an orthopedic device or implant (e.g., alignment in the patient, displacement or loosening in the patient). Representative examples of sensors suitable for use within the present disclosure include, for example, chemistry sensors (e.g., for blood and / or other fluids), metabolic sensors (e.g., for blood and / or other fluids), analyte sensors (e.g., for glucose), pH sensors, temperature sensors, fluid pressure sensors, fluid volume sensors, contact sensors, position sensors, pulse pressure sensors, blood volume sensors, blood flow sensors, accelerometers, gyroscopes, step counters, and mechanical stress sensors. Within certain embodiments the sensor can be a wireless sensor, or, within other embodiments, a sensor connected to a wireless microprocessor. In one embodiment a cartridge for obtaining kinematic information about the host comprises one or more accelerometers, one or more gyroscopes, or a combination of one or more accelerometers and one or more gyroscopes. In one embodiment the sensors within a cartridge for obtaining kinematic information about the host consist of one or more accelerometers, one or more gyroscopes, or a combination of one or more accelerometers and one or more gyroscopes. In one embodiment a cartridge for obtaining kinematic information about the host comprises one or more accelerometers, one or more gyroscopes, or a combination of one or more accelerometers and one or more gyroscopes, but does not include any secondary sensors that do not measure movement of the host.

[0049] Within further embodiments one or more (including all) of the sensors can have a Unique Sensor Identification number ("USI") which specifically identifies the sensor. In certain embodiments, the sensor is a device that can be utilized to measure in a quantitative manner, one or more different aspects of a body tissue (anatomy, physiology, metabolism, and / or function) and / or one or more aspects of the implant. In certain embodiments, the sensor is an accelerometer that can be utilized to measure in a quantitative manner, one or more different aspects of a body tissue (e.g., function) and / or one or more aspects of the implant (e.g., alignment in the patient).

[0050] A wide variety of sensors (also referred to as Microelectromechanical Systems or "MEMS," or Nanoelectromechanical Systems or "NEMS," and BioMEMS or BioNEMS) can be utilized within the present disclosure.Smart Cartridge

[0051] The present disclosure provides a smart cartridge that collects data related to a body part.

[0052] For example, the present disclosure provide a smart cartridge for collecting kinematic data from a subject, comprising: an electronics assembly comprising at least one sensor, and a controller configured to collect kinematic data resulting from movement of a knee sensed by the at least one sensor; and a housing enclosing the electronics assembly; wherein the smart cartridge is not connected to an artificial knee, hip, or shoulder prosthesis.

[0053] As another example, the present disclosure provides a smart cartridge for collecting kinematic data from a subject, comprising: an electronics assembly comprising at least one sensor, and a controller configured to collect kinematic data resulting from movement of a hip sensed by the at least one sensor; and a housing enclosing the electronics assembly; wherein the smart cartridge is not connected to an artificial knee, hip, or shoulder prosthesis.

[0054] As a further example, the present disclosure provides a smart cartridge for collecting kinematic data from a subject, comprising: an electronics assembly comprising at least one sensor, and a controller configured to collect kinematic data resulting from movement of a shoulder sensed by the at least one sensor; and a housing enclosing the electronics assembly; wherein the smart cartridge is not connected to an artificial knee, hip, or shoulder prosthesis.

[0055] In another example, the present disclosure provides a smart cartridge for collecting kinematic data from a subject, comprising: an electronics assembly comprising at least one sensor, and a controller configured to collect kinematic data resulting from movement of a vertebrae sensed by the at least one sensor; and a housing enclosing the electronics assembly; wherein the smart cartridge is not connected to an artificial knee, hip, or shoulder prosthesis.

[0056] The smart cartridge may collect data related to a bone that is associated with a joint to monitor recovery progress of a joint surgery. The smart cartridge may be an assembly that is manufactured independently from other components of an implant system and later assembled together with another component of the implant system. In other configurations, the smart cartridge can be integrated with a component of the implant system during manufacture of the component. In some configurations, the smart cartridge may be implanted into the body without being integrated with another component. The smart cartridge may be configured to be integrated with a bone, referred to herein at times as a "host bone". For example, for the purpose of collecting data relevant to a knee, the smart cartridge may be integrated with a femur or a tibia. For the purpose of collecting data relevant to the hip, the smart cartridge may be integrated with a femur. For purposes of collecting data relevant to the shoulder, the smart cartridge may be integrated with a humerus. Whenintegrated, the smart cartridge may still include any features of the separate cartridge described herein. In some embodiments, the present disclosure provides a smart cartridge that is intended to be implanted in a host bone, e.g., a tibia, where the smart cartridge monitors the state of the device after implantation, typically by obtaining kinematic data in the range of about 10-120 Hz.

[0057] As discussed herein, the state of the device may include the integrity of the device, the movement of the device, the forces exerted on the device and other information relevant to the implanted device. The present disclosure also provides medical devices having a structure such that they can be readily fitted with a smart cartridge. An implantable medical device that has been fitted with a smart cartridge may be referred to herein as an intelligent implant, in recognition that the implant is monitoring its own state or condition to thereby obtain data, where that data is stored in the implant and then as needed, that data is transmitted to a separate device for review by, e.g., a physician.

[0058] For example, an intelligent implant of the present disclosure having suitable internal electronic components may be utilized to monitor and measure the movements of a surgical patient's movements and kinematics after surgery (e.g., activity, gait, steps, posture, laxity, flexion / extension, range of motion, etc.) after a joint repair or replacement surgery. The intelligent implant may store the measurement data and unique identification information of the implant components and transfer the data to an external recipient (e.g., doctor, clinician, medical assistant, etc.) as required. The smart cartridge may include one or more sensors, such as gyroscopes, accelerometers, temperature and pressure sensors, or other sensors, and these sensors may be located anywhere on or within the smart cartridge outer housing.

[0059] The intelligent implant intended to be implanted into a living subject, e.g., a mammal, e.g., a human, horse, dog, etc. Accordingly, in some embodiments the intelligent implant is sterile, e.g., is treated with sterilizing radiation or is treated with ethylene oxide. In some examples, an intelligent implant comprising the smart cartridge, and optionally a separate implantable component, may be sterile, again optionally by treatment with sterilizing radiation or ethylene oxide, as two examples. In order to be protected from the in vivo environment, the smart cartridge may be hermetically sealed, so that fluids cannot enter the smart cartridge.

[0060] The integration of the smart cartridge into any one of the host bones may be enabled by a receptacle of the host bone. The receptacle may be an empty space, e.g., a cavity, a hole,or a void, in a rigid feature of the host bone. For example, the receptacle may be formed by drilling into a solid portion of the host bone. The empty space may have a form factor configured to receive a smart cartridge. "Form factor" as used herein can refer to physical characteristics, e.g., three-dimensional shape and size, of a structure or an empty space. In some embodiments, the receptacle may have a form factor that is almost identical to that of the smart cartridge. For example, the receptacle may mimic the three-dimensional shape of an insertion portion of the smart cartridge that is configured to be received in the receptacle. The receptacle may be sized only slightly larger than the smart cartridge to allow the insertion of the smart cartridge and minimizing the amount of empty space left in the receptacle after the smart cartridge has been inserted. However, in some cases, the receptacle may be smaller or identical to an insertion portion of the smart cartridge.

[0061] The smart cartridge may include various electronics including one or more sensors and a joint-specific module. The joint-specific module may be configured to control data- collection functionality of the smart cartridge to collect data relevant to a particular joint of the body. A joint-specific module may comprise firmware and / software configured to operate the smart cartridge in a manner specific to the host bone in which the smart cartridge is integrated.

[0062] A knee module may be configured to control the data-collection functionality of the smart cartridge to obtain kinematic information associated with motion of a host knee or leg implant. The knee module may include two submodules, one that operates the smart cartridge to obtain kinematic information associated with motion of a left knee, and a second that operates the smart cartridge to obtain kinematic information associated with motion of a right knee.

[0063] A hip module may be configured to control the data-collection functionality of the smart cartridge to obtain kinematic information associated with motion of a host hip implant. The hip module may include two submodules, one that operates the smart cartridge to obtain kinematic information associated with motion of a left hip implant, and a second that operates the smart cartridge to obtain kinematic information associated with motion of a right hip implant.

[0064] The shoulder module may be configured to control the data-collection functionality of the smart cartridge to obtain kinematic information associated with motion of a host shoulder implant. The shoulder module may include two submodules, one that operates the smartcartridge to obtain kinematic information associated with motion of a left shoulder, and a second that operates the smart cartridge to obtain kinematic information associated with motion of a right shoulder.

[0065] The smart cartridge may also include communication components, e.g., a transceiver and antenna, that transmits collected data and receives operational data, e.g., software / fi rmware updates. The smart cartridge may also include a memory to store the data generated by the sensor, where that data can be made available at selected times to be transmitted outside of the smart cartridge via the antenna to, e.g., a base station.

[0066] With reference to FIGS. 1A, IB, and 1C, for example, a smart cartridge 100 may include an outer casing or housing 102 that encloses a power component, e.g., a battery 104, an electronics assembly 106. The smart cartridge 100 may further include a shroud 108 and a feedthrough assembly 110. The smart cartridge 100 may further include an antenna assembly 112 coupled to the housing 102. The antenna assembly 112 may include an antenna 114 that couples to the electronics assembly 106 through the feedthrough assembly 110, and a cover or cap 116 (transparent in FIGS. 1A, IB, and 1C) that covers and protects the antenna 114. The cap 116, also referred to herein as a radome, can be made from any material, such as plastic or ceramic, which allows radio frequency (RF) signals to propagate through the radome with acceptable levels of attenuation and other signal degradation. For example, the cap 116 may be comprised of polyetherether-ketone (PEEK).

[0067] The housing 102 of the smart cartridge 100 may include a lower portion 122 and an upper portion 124. These portions 122, 124 can be respectively sized and shaped to define a three-dimensional form factor of the smart cartridge 100 that enables the cartridge to fit into a receptacle of a patient bone. The receptacle formed in a host bone may have a form factor that receives at least the lower portion 122 of the smart cartridge 100. For example, the smart cartridge 100 shown in FIGS. 1A, IB, and 1C has a cylindrical form factor. However, as described later in this disclosure, the form factor of the smart cartridge may have different geometries.

[0068] With continued reference to FIGS. 1A-1C, the housing 102 may have a length L between 35 mm and 50 mm, for example, 35 mm, 40 mm, 45 mm, 50 mm, or any length within a range defined by any of these values. The overall length of the smart cartridge 100, from the bottom of the housing to the top of the antenna assembly 112 may be between 40 mm and 60 mm, for example, 40 mm, 42 mm, 44 mm, 46 mm, 48 mm, 50 mm, 52 mm, 54mm, 56 mm, 58 mm, 60 mm, or any length within a range defined by any of these values. The overall length of the smart cartridge 100 may be less than or equal to 60 mm. Thus, the antenna assembly 112 may have a height between 3 mm and 8 mm. The antenna assembly 112 may have a length of less than or equal to 8 mm. The part of the housing 102 corresponding to the lower portion 122 of the smart cartridge 100 may have a lower diameter DI between 7.5 mm and 10.0 mm. The lower portion 122 of the smart cartridge 100 may have a diameter of less than or equal to 10.0 mm, or less than or equal to 9.0 mm. The part of the housing corresponding to the upper portion 124 of the smart cartridge may have an upper diameter D2 between 9.0 mm and 12.0 mm. The upper portion 124 of the smart cartridge 100 may have a diameter less than or equal to 12.0 mm. As discussed elsewhere herein, additional exemplary dimensions are provided for the smart cartridge (also referred to smart implant or cartridge).

[0069] With reference to FIGS. 2A and 2B, the upper portion 124 of the housing 102 may include an alignment feature 204, e.g., a tab, and a securing mechanism 206. As described elsewhere herein, the alignment feature 204 may be configured to align with corresponding alignment features of a securing device that is inserted into the receptacle of the host bone.

[0070] With continued reference to FIGS. 2A and 2B, the upper portion 124 of the housing 102 may include a securing mechanism 206. As described elsewhere herein, the securing mechanism 206 may be configured to engage a corresponding securing feature of a securing device also inserted into the receptacle of a host bone. For example, the securing mechanism 206 may comprise threads. In some embodiments, the securing feature 206 may comprise a retaining ring.

[0071] With reference to FIGS. 1A-1C, the battery 104 may be configured to power the circuitry of the electronics assembly 106 of the smart cartridge 100 over a significant portion (e.g., 1 - 15+ years, e.g., 10 years, or 15 years), or the entirety (e.g., 18+ years), of the anticipated lifetime of the smart cartridge 100. In some embodiments, the battery 104 has a lithium-carbon-monofluoride (LiCFx) chemistry. With an LiCFx chemistry, the battery 104 can provide, over its lifetime, about 360 milliampere hours (mAh) at 3.7 volts (V), although one can increase this output by about 36 mAh for each 5 mm of length added to the battery (similarly, one can decrease this output by about 36 mAh for each 5 mm of length subtracted from the battery). It is understood that other battery chemistries can be used if they can achieve the appropriate power requirements for a given application subject to the size andlongevity requirements of the application. Some additional potential battery chemistries include, but are not limited to, Lithium ion (Li-ion), Lithium Manganese dioxide (Li-MnO2), silver vanadium oxide (SVO), Lithium Thionyl Chloride (Li-SOCI2), Lithium iodine, and hybrid types consisting of combinations of the above chemistries such as CFx-SVO.

[0072] The antenna assembly 112 may include an antenna 114 that couples to a radio transmitter integrated circuit of the electronics assembly 106 and a cap, or radome, 116 that protects the antenna. The antenna 114 illustrated in this disclosure is a substrate antenna. In other configurations, the antenna 114 may be a loop antenna or a helix antenna. Examples of these antenna 114 configurations are disclosed, for example, in International PCT Application Serial No. PCT / US23 / 15224, which is incorporated by reference.

[0073] The electronics assembly 106 may include printed circuit boards surrounded by a liner 118. The liner 118 may function to mechanically stabilize the electronics assembly 106 within the housing 102. The electronics assembly 106 may fit within and be surrounded by the shroud 108, which is formed of a biocompatible metallic material. In some embodiments, the material is titanium. The shroud 108 may include a flange 120.

[0074] The printed circuit boards of the electronics assembly 106 may include one or more sensors and a controller configured to receive and process information from the one or more sensors relating to the state and functioning of the host bone in which the smart cartridge 100 is integrated, and the state of the patient within which the host bone is implanted. The electronics assembly 106 may be further configured to transmit the processed information to an external device through the antenna assembly 112.

[0075] The electronics assembly 106 may be coupled physically and electrically to the antenna 114 through terminals on the antenna terminal board, and to the battery 104 through terminals on the battery terminal board. The electronics assembly 106 may include an Inertial Measurement Unit (IMU) integrated circuit, a Real-Time Clock (RTC) integrated circuit, a memory integrated circuit (Flash), and other circuit components on one side, and a microcontroller (MCU) integrated circuit, a radio transmitter (RADIO) integrated circuit, and other circuit components on the other side. In any event, the folded electronics assembly 106 may provide a compact configuration that conserves a significant amount of physical space in the smart cartridge. Details on the electronics assembly 106 are provided below. Additional details are also disclosed in PCT Publication No. WO 2022 / 266085, which is incorporated by reference.

[0076] In some embodiments, the smart cartridge may have a capsule or ellipsoid shape. FIG. 14 illustrates a smart cartridge 1400 with a capsule shape, e.g., a cylinder with hemispherical ends. The smart cartridge 1400 may include an outer casing or housing 1402 that encloses a power component, e.g., a battery 1412 and an electronics assembly 1404. The smart cartridge 1400 may include one or more sensors, as discussed elsewhere herein. The smart cartridge 1400 may include an antenna 1408. The antenna 1408 may be a wire antenna, a conformal antenna, or a planar antenna. The housing 1402 of the smart cartridge 1400 may comprise a biocompatible material, e.g., silicone, parylene. The housing 1402 may comprise a bone growth material to promote bone growth and healing. The smart cartridge 1400 may be configured to interface with an interference screw used in an ACL surgery. For example, the smart cartridge 1400 may be integrated with an interference screw implanted in a through hole formed for an ACL reconstruction to secure an ACL graft. In some embodiments, the smart cartridge 1400 may be configured to be subcutaneously implanted intramuscularly, e.g., in a muscle pocket (a location within adjacent musculature that naturally provides for a cavity where the smart cartridge may be located, without need to cut muscle tissue) near a joint undergoing surgery. For example, the smart cartridge 1400 may be implanted in a muscle pocket between the tibia and fibula to monitor an ACL surgery. The smart cartridge 1400 may have smaller dimensions than the cylindrical smart cartridge 100 illustrated in FIG. 1. The smart cartridge 1400 may include a battery 1412 with smaller dimensions than the battery 104, but having a shorter lifespan. The smart cartridge 1400 may be configured to have a lifespan of at least 1 year to monitor the recovery of a joint surgery, e.g., ACL surgery. The smart cartridge 1400 may have a length between 20 mm and 50 mm. The smart cartridge 1400 may have a length less than or equal to 45 mm, or a length less than or equal to 35 mm. When the smart cartridge has a generally cylindrical shape, then the smart cartridge 1400 may have a diameter between 6 mm and 15 mm. The smart cartridge 1400 may have a diameter less than or equal to 10 mm, or less than or equal to 8 mm. When the smart cartridge has a generally rectangular shape, then the smart cartridge 1400 may have a widest width of between 6 mm and 15 mm, and a deepest depth of between 6 mm and 15 mm, where the width may be less than or equal to 10 mm, or less than or equal to 8 mm and the depth may be less than or equal to 10 mm, or less than or equal to 8 mm.Joint Surgery Monitoring

[0077] A smart cartridge may be implanted at or near a joint to collect data relevant to thejoint, as described herein. The smart cartridge may be used to monitor the recovery progress of a joint surgery. For example, the joint surgery may be an ACL surgery in a knee joint of a patient. For the purpose of collecting data relevant to a joint, the smart cartridge may be implanted in or near a bone associated with the joint. In some embodiments, the smart cartridge may be integrated with the bone, e.g., received in a receptacle formed in the bone. In some embodiments, the smart cartridge may be subcutaneously implanted adjacent to the bone. For example, for the purposes of monitoring an ACL surgery, the smart cartridge may be implanted at least partially within or near a tibia of a patient in a leg of a patient undergoing the surgery.

[0078] The smart cartridge may collect kinematic data associated with the joint, as described elsewhere herein. The smart cartridge may collect data indicative of joint activity. For example, with respect to a knee joint, the smart cartridge may collect activity data such as step count, cadence, and / or distance walked. With further respect to an example smart cartridge monitoring a knee, the smart cartridge may collect data indicative of a patient's gait. The gait data may include a functional knee range of motion, a tibial range of motion, an average walking speed, and / or a stride. The smart cartridge may collect data indicative of an alignment or stability of a joint. The alignment or stability data may include a medial-lateral (M-L) motion of a bone associated with the joint. The M-L motion data may be indicative of a laxity of the joint. The alignment or stability data may include an anterior-posterior (A-P) motion of a bone associated with the joint. The A-P motion data may be indicative of a flexion / extension of the joint. The kinematic data collected by the smart cartridge may be used to evaluate the recovery progress of the joint surgery. For example, to monitor the recovery of an ACL surgery, the M-L motion data and / or the A-P motion data of a tibia may be collected at the moment a heel strike occurs. The motion data may be indicative of a laxity and / or the flexion / extension of the knee joint. The recovery of the ACL surgery may be monitored by observing the changes in a laxity and / or a flexion / extension, among other things, of the injured knee over time.

[0079] The smart cartridge may include various electronics including one or more sensors and a joint-specific module, which may be configured to control data-collection functionality of the smart cartridge to collect data relevant to a specific joint of the body. For example, for monitoring of an ACL surgery, the smart cartridge may include a knee-specific module. The knee module may be configured to control the data-collection functionality of the smartcartridge to obtain kinematic information associated with motion of a host bone associated with the knee. The knee module may include two submodules, a first submodule that operates the smart cartridge to obtain kinematic information associated with motion of a bone associated with a left knee, and a second submodule that operates the smart cartridge to obtain kinematic information associated with motion of a bone associated with a right knee.

[0080] A torn ACL may cause significant pain, swelling, and instability in a patient, thus requiring an ACL surgery. An ACL surgery may include an ACL reconstruction (ACL-R) or an ACL repair, which are different approaches to addressing an ACL tear. A primary ACL repair involves suturing a torn ACL back together to try to preserve and restore the ligament's native structure. The ACL repair may or may not use a donor graft. An ACL repair may use a tensioned element, e.g., a rope or a suture implant, to provide support to the ligament. The rope or suture may extend from the ACL out of the tibia. The rope or suture may extend through a cortical button secured to the surface of the bone. The end of the rope or suture extending out of the tibia may be secured to the tibia by interference screws or other fixation methods. For example, a rope used for an ACL repair may extend out of the tibia and be wrapped around an insertion end of an interference screw, which is inserted into a hole drilled in the tibia at a location distal to the ACL repair site.

[0081] An ACL-R may include the replacement of a torn ACL with an ACL graft. The graft may be taken from the patient's own body, i.e., an autograft, or from a donor, i.e., an allograft, or may be a synthetic graft. The ACL-R procedure may include drilling a through hole through each of the femur and the tibia on either side of the knee. The through holes may receive the ACL graft and act as a pathway for the graft. The through holes may be positioned to mimic the natural orientation of the original ACL. The ACL graft may be secured within the through holes using interference screws or other fixation methods. The ACL graft may be secured with a certain tension, which may be decided by the physician. For example, the ACL graft may be secured at a certain tension with an interference screw that is inserted into the through holes in the tibia and / or femur to interface with the bone and the graft. The interference screw may have a form factor that provides an force-fit to compress the graft against the interior surface of the bone and prevent movement of the graft from the set position. The interference screws may comprise a biocompatible material, e.g. titanium or PEEK. The interference screws may comprise a metallic material, a polymeric material, or a combination thereof. The interferencescrews may range from 15 mm to 35 mm in length, and 7 mm to 11 mm in diameter. The through holes may be sealed with a cortical button that prevents the ACL graft and / or securing mechanism from exiting the hole. The ACL-R may use additional supporting or tensioned elements such as one or more ropes or sutures to support the ACL graft and / or maintain the set tension. The rope or suture implants may extend through the cortical button.

[0082] A key aspect of an ACL surgery and subsequent recovery is applying and maintaining the correct amount of tension in the ACL or ACL graft. The smart cartridge may collect data for monitoring the recovery of an ACL surgery, e.g., ACL reconstruction or ACL repair, according to embodiments. The smart cartridge may monitor the ACL from a location in the vicinity of the ACL. For example, the smart cartridge may be integrated into the proximal tibia near the ACL surgery. After an ACL surgery, the patient is often instructed not to load bear on the operated knee. After about 6-8 weeks, the patient may be allowed to load-bear on the knee. The smart cartridge may monitor the progress of the load-bearing of the patient throughout the recovery process. The smart cartridge may collect kinematic data that is indicative of flexion and / or extension of the knee. If the tension in the ACL surgery is too loose, there may be laxity of the knee joint, which is defined as abnormal displacement or rotation of the tibia with respect to the femur. On the other hand, if the tension in the ACL surgery is too tight, the knee may not be able to properly extend or retract. Thus, the ACL needs to be appropriately tensioned within a desired range of flexibility enough to allow for extension, while not causing laxity. If the ACL is not within the desired range of flexibility, a physician can perform a slight modification, or revision, midway through the recovery. If the revision is not performed, the patient may be stuck with the ACL that is too tight or too loose, or may require an additional cumbersome surgery.

[0083] The smart cartridge may monitor the quality of the ACL surgery by collecting data indicative of the laxity, flexion / extension, retraction, etc. of the knee. The smart cartridge may not need to be within the ACL itself to perform said monitoring, rather need only be in the vicinity of the ACL. For example, the smart cartridge may be configured to collect motion data at a heel strike while the patient is walking. The motion data may be indicative of an alignment of the knee. The motion data may comprise a measurement of medial-lateral (M-L) motion and / or anterior-posterior (A-P) motion. The M-L motion data may be indicative of a laxity of the knee. The A-P motion data may be indicative of a flexion and / or extension of the knee. In some embodiments, the smart cartridge may monitor the quality of the ACL surgery by alsocollecting data indicative of the tension in the ACL. For example, the smart cartridge may be integrated in the through hole of the bone along with an ACL graft. The smart cartridge may collect alignment data that may indicate an initial, set tension of the ACL. The collected alignment data may be indicative of a tension change in the ACL, or a complete loss of tension in the ACL, based on a shift in alignment. The smart cartridge may include strain or force sensors to detect a strain or force on the surface of the smart cartridge as a means of detecting tension of the ACL graft. In some embodiments, the smart cartridge may comprise a temperature sensor which may be able to detect an infection in the ACL graft.

[0084] In some embodiments, an ACL monitoring smart cartridge may include position and / or orientation sensors. The position / orientation sensors may be flexible sensors located outside of the housing of the smart cartridge, such as a flexible ring sensor or a flexible strip sensor. The position / orientation sensors may be integrated about a cortical button or inside an ACL- R through hole. The position sensors may detect the tension of the ACL-R replacement ligament, and further detect a change in tension by force or pressure response. If a force or pressure is increased or decreased by a significant amount without returning to baseline, then one can conclude that a shift has occurred with the femur / tibia alignment or knee position. In some embodiments, the position sensors may include magnetic sensors for angular or linear position detection.

[0085] The smart cartridge may have a life cycle that extends throughout the duration of a recovery from the ACL surgery, which may be about 1-2 years. The smart cartridge may or may not be configured for continuous monitoring. In some embodiments, the smart cartridge may be patient-initiated or may be configured to detect motion to automatically begin monitoring. The smart cartridge may or may not be removable or retrievable. For example, a smart cartridge implanted in a ACL-R through hole may not be removeable, as it may be securing the ACL graft. On the other hand, a smart cartridge that is subcutaneously implanted near a tibia may be removable and may be able to be reimplanted.

[0086] Although several embodiments are described herein with respect to monitoring of an ACL surgery in the knee, the disclosed features may be used for smart cartridges configured to monitor other joint surgeries, such as rotator cuff repair, knee replacement, hip replacement, etc.Host Bone Integration of Smart Cartridge

[0087] Disclosed herein are intelligent implants comprising a smart cartridge and configuredto be integrated in a host bone having a receptacle configured to receive the implant. The receptacle, also referred to herein as a cartridge receptacle or a bone receptacle, may be formed in a host bone near a joint surgery, e.g., a joint repair or reconstruction surgery. The smart cartridge and the receptacle are configured such that the smart cartridge can be integrated with the host bone, where such integration is achieved through respective configurations of the smart cartridge and the host bone that enable insertion of the smart cartridge into the cartridge receptacle and securing of the cartridge therein. The cartridge receptacle may be created by the physician that is operating on the joint. For example, the physician may create the receptacle by drilling a hole in the host bone.

[0088] The intelligent implant may further include a securing feature. In some embodiments disclosed herein, the smart cartridge and the host bone may have corresponding securing features that cooperate to secure the smart cartridge within the host bone upon insertion of the smart cartridge into the receptacle, where upon insertion includes the time when insertion is complete, and the smart cartridge has been finally inserted into the receptacle. It may be said that the two corresponding securing features are complementary to one another so that when the two features are engaged or joined together, they interact to create a connection that securely holds the smart cartridge within the receptacle. A securing feature may also be referred to as a locking mechanism or a securing mechanism. The securing feature may be a securing insert that is a separate component from the smart cartridge. The securing feature may have a surface feature that enables the intelligent implant to associate with the receptacle to secure the implant in the receptacle.

[0089] In some embodiments, the securing feature provides a force-fit or friction-fit that secures the smart cartridge in the host bone independent of any other securing features. In other words, the smart cartridge is secured within the receptacle solely by frictional forces. Particularly when securing a smart cartridge in a receptacle solely by friction forces, pressure may be used to force the two complementary pieces together, where pressure develops a so- called force-fit between the pieces, whereby the pieces are held together by frictional forces. In some embodiments, the securing features may secure the smart cartridge in the host bone independent of any friction force. Particularly, the implant may comprise a feature configured solely as a securing feature, and the receptacle may comprise a feature configured solely as a securing feature that is complementary to the securing feature of the smart cartridge. For example, the securing feature may comprise threads.

[0090] In some embodiments, the smart cartridge is aligned relative to a host bone and is secured within a receptacle of the host bone to achieve at least two results. A first result may be that the smart cartridge cannot easily be removed from the host bone. The smart cartridge may be secured within the receptacle so that after the cartridge and optionally the securing feature are implanted in a patient, the smart cartridge remains secured during normal daily activities of the patient for the expected lifetime of the cartridge. The second result may be that the smart cartridge remains in constant alignment with the host bone. The smart cartridge may be secured within the receptacle so that after the smart cartridge is implanted in the patient, the smart cartridge does not rotate and / or migrate within the receptacle during normal daily activities of the patient for the expected lifetime of the cartridge.

[0091] Following are examples of intelligent implants, wherein a same smart cartridge can be integrated with each of a different type of host bone associated with a joint, including a hip, a knee, and a shoulder.

[0092] An intelligent implant may include a smart cartridge and a securing insert configured to secure the smart cartridge in a receptacle of a host bone. The smart cartridge and the securing insert both having form factors such that the implant may be inserted into the receptacle. The receptacle may be formed by drilling into a solid portion of the host bone. The receptacle may be formed to extend orthogonally, or almost orthogonally, to a longitudinal axis of the host bone. The receptacle may be formed at an angle between 45 degrees and 90 degrees to the longitudinal axis of the host bone. The receptacle may have internal threads formed therewithin by the drilling. The receptacle may be located near a site of a joint surgery. The receptacle may be formed by the surgeon performing the joint surgery. The smart cartridge may be coupled with the securing insert to secure the smart cartridge within the receptacle. The securing insert may be inserted into the receptacle before the smart cartridge, such that the smart cartridge is coupled to the securing feature within the receptacle. The securing insert may comprise a securing feature, e.g., threads, to secure the implant at least partially within the receptacle. The smart cartridge may be inserted at least partially into the receptacle having the securing insert and interface with the securing insert. The smart cartridge may be secured to the securing insert by a coupling feature, which may secure the smart cartridge at least partially within the receptacle. The coupling feature may comprise a retaining ring, threads, locking tabs, keys, etc. In some embodiments, the smart cartridge may be coupled to the securing insert before the implant is inserted into thereceptacle. The smart cartridge may extend out of the receptacle when fully inserted and coupled with the securing insert. The portion of the cartridge extending out of the receptacle may comprise an antenna. In some embodiments, the smart cartridge may extend fully within the receptacle.

[0093] With reference to FIG. 3, an intelligent implant system may include a smart cartridge 300 having a cylindrical form factor configured to be inserted into a corresponding receptacle 304 of a host bone. The receptacle may be formed by drilling into a solid portion of the host bone near the site of a joint surgery. The joint may be a knee 316 between a femur 310 and a tibia 312. For example, as shown in FIG. 3, the receptacle 304 is located in the tibia 312 distal to a cortical button 306 used for an ACL surgery. The receptacle 304 may be configured to receive a securing insert that is used to secure the smart cartridge 300 in the receptacle 304. For example, as shown in FIG. 3, the securing insert may comprise a threaded screw 308. Into the receptacle 304, which may be created by the surgeon who is performing the ACL surgery, is first placed a threaded screw 308. The threaded screw 308 may provide a securing feature that is used to secure the implant in the receptacle 304. The securing feature may comprise threads that may mate with corresponding threads formed in the interior walls of bone receptacle 304. The smart cartridge 300 may then be inserted at least partially into the receptacle 304 and interface with the threaded screw 308. The smart cartridge 300 may be secured to the threaded screw 308 by a retention ring 320 received in an annular groove 412 formed in the interior walls of the threaded screw 308 (see FIGS. 4A-4C), which thereby secures the smart cartridge 300 at least partially within the receptacle. A portion of the smart cartridge 300 may extend out of the receptacle when the cartridge 300 is fully inserted. The portion extending out of the receptacle may comprise a radome 324 (see FIG. 4C) that houses an antenna of the smart cartridge 300. The portion of the smart cartridge 300 extending out of the receptacle and cortical bone may have a length of about 5-8 mm.

[0094] FIG. 4A illustrates a perspective view of a threaded screw 308. The threaded screw 308 comprises external threads that may mate with corresponding threads formed in the receptacle of the host bone to secure an implant. FIG. 4B shows the threaded insert 308 in a cross-sectional view. The threaded insert 308 may comprise an annular groove 412 formed on the interior wall of the threaded screw 308 configured to receive a retaining ring 320 of the smart cartridge 300. The threaded insert 308 may also comprise an alignment feature formed on the interior wall of the threaded screw 308. The alignment feature may comprisea slot 408 configured to receive a corresponding tab on the smart cartridge 300. The alignment feature may allow the smart cartridge to remain in a constant alignment relative to the securing feature and the host bone, since the smart cartridge 300 cannot rotate within the receptacle. Referring to FIG. 4B, the outer diameter A of the threaded insert 308 may be between 9 mm and 14 mm, or less than or equal to 14 mm. The wall thickness B of the threaded insert 308 may be between 0.3 mm and 1.5 mm, or less than or equal to 1.5 mm. The lower inner diameter C of the threaded insert 308 may be between 7.5 mm and 10 mm, or less than or equal to 10 mm. The upper inner diameter E of the threaded insert 308 may be between 9 mm and 12 mm, or less than or equal to 12 mm. The shoulder outer diameter D of the threaded insert 308 may be between 13 mm and 19 mm, or less than or equal to 19 mm.

[0095] FIG. 4C illustrates two embodiments of the smart cartridge 300 of FIG. 3, specifically a "short" cartridge and a "tall" cartridge. The short cartridge may have a lower portion with a diameter between 7 mm and 10 mm, less than or equal to 10 mm, for example 9.5 mm, less than or equal to 9 mm, less than or equal to 8 mm, or ranges therebetween. The short cartridge may have a larger cross-sectional diameter than the tall cartridge. The tall cartridge may have a lower portion with a diameter between 5 mm and 8 mm, less than or equal to 8 mm, for example 7.75 mm, less than or equal to 7 mm, less than or equal to 6 mm, or ranges therebetween. The length of the short cartridge may be between 30 mm and 50 mm, less than or equal to 50 mm, for example 44 mm, less than or equal to 45 mm, less than or equal to 40 mm, less than or equal to 35 mm, or ranges therebetween. The length of the tall cartridge may be between 40 mm and 60 mm, less than or equal to 60 mm, for example 52 mm, less than or equal to 55 mm, less than or equal to 50 mm, less than or equal to 45 mm, or ranges therebetween. The length of the radome 324 may be equal for each of the short and tall cartridges. The radome may have a length between 5 mm and 8 mm, for example, 7.5 mm.

[0096] An intelligent implant may include a smart cartridge comprising a housing including one or more surface features that enables the smart cartridge to associate with a receptacle of a host bone to secure the smart cartridge at least partially within the receptacle. The receptacle may be formed by drilling into a solid portion of the host bone. The receptacle may have internal threads formed therewithin by the drilling. The receptacle may be located near a site of a joint surgery. The receptacle may be formed by the surgeon performing the jointsurgery. The surface feature(s) on the housing of the smart cartridge may comprise external threads that may be configured to mate with the threads of the receptacle. The surface feature(s) of the housing may comprise a keyed flange configured to be located at a cortical bone interface when the smart cartridge is implanted in the receptacle.

[0097] With reference to FIG. 5, an intelligent implant system may comprise a smart cartridge 500 having a cylindrical form factor and configured to be inserted in a corresponding receptacle 504 of a host bone. The receptacle 504 may be formed by drilling into a solid portion of the host bone near the site of a joint surgery. The joint may be a knee 316 between a femur 310 and a tibia 312. For example, as shown in FIG. 5, the receptacle 504 is located in the tibia 312 distal to a cortical button 306 used for an ACL surgery. The smart cartridge 500 may comprise a housing having external threads 520 (see FIG. 6) configured to secure the smart cartridge 500 in the receptacle 504. The external threads 520 of the housing may mate with internal threads of the receptacle 504. A portion of the smart cartridge 500 may extend out of the receptacle 504 when the cartridge 500 is fully inserted and secured. The portion extending out of the receptacle 504 may comprise a radome 524 (see FIG. 6) that houses an antenna of the smart cartridge 500. The smart cartridge 500 may comprise a tooling feature to allow the threading the smart cartridge 500 into the receptacle 504. The receptacle 504 may have dimensions that are about the same or only slightly larger than the housing of the smart cartridge 500, such that the smart cartridge 500 may fit within the receptacle with little to no empty space between the cartridge and the walls of the receptacle to prevent undesirable migration of the cartridge within the receptacle.

[0098] FIG. 6 illustrates two embodiments of the cartridge 500 of FIG. 5, specifically a "short" cartridge and a "tall" cartridge. The intelligent implant of FIGS. 5 and 6 does not include a separate securing device for the cartridge because the housing of the cartridge includes features, e.g., threads 520, on the exterior surface of the housing, that can be used to secure the cartridge directly in the receptacle. The short cartridge may have a lower insertion portion with a diameter between 7 mm and 10 mm, less than or equal to 10 mm, for example 9.5 mm, less than or equal to 9 mm, less than or equal to 8 mm, or ranges therebetween. The short cartridge may have a larger cross-sectional diameter than the tall cartridge. The tall cartridge may have a lower insertion portion with a diameter between 5 mm and 8 mm, less than or equal to 8 mm, for example 7.75 mm, less than or equal to 7 mm, less than or equal to 6 mm, or ranges therebetween. The short cartridge may have an upper threaded portionwith a diameter between 8 mm and 11 mm, less than or equal to 11 mm, for example 10.9 mm, less than or equal to 10 mm, less than or equal to 9 mm, or ranges therebetween. The tall cartridge may have an upper threaded portion with a diameter between 8 mm and 10 mm, less than or equal to 10 mm, for example 9.1 mm, less than or equal to 9 mm, or ranges therebetween. The length of the short cartridge may be between 30 mm and 50 mm, less than or equal to 50 mm, for example 44 mm, less than or equal to 45 mm, less than or equal to 40 mm, less than or equal to 35 mm, or ranges therebetween. The length of the tall cartridge may be between 40 mm and 60 mm, less than or equal to 60 mm, for example 52 mm, less than or equal to 55 mm, less than or equal to 50 mm, less than or equal to 45 mm, or ranges therebetween. The length of the radome 324 may be equal for each of the short and tall cartridges. The radome may have a length between 5 mm and 8 mm, for example, 7.5 mm.

[0099] With reference to FIG. 7, an intelligent implant system may comprise a smart cartridge 700 having a cylindrical form factor and configured to be inserted in a corresponding receptacle 704 of a host bone. The smart cartridge 700 may comprise a housing having external threads configured to secure the smart cartridge 700 in the receptacle 704. The receptacle 704 may be formed by drilling into a solid portion of the host bone near the site of a joint surgery. The joint may be a knee 316 between a femur 310 and a tibia 312. For example, as shown in FIG. 7, the receptacle 704 is located in the tibia 312 distal to a cortical button 306 used for an ACL surgery. The external threads 720 (see FIGS. 8A-8B) of the cartridge housing may mate with internal threads of the receptacle 704. The smart cartridge 700 may further include a keyed flange 722 (see FIGS. 8A-8B). The keyed flange 722 may be located at a cortical bone interface of the host bone when the smart cartridge 700 is fully implanted within the receptacle 704. The thickness of the flange, e.g., 2 mm, may be similar to a tensioned element used in an ACL surgery, such as a rope or a suture, such that the tensioned element may be wrapped around the cartridge 700 and received by the flange 722. The tensioned element may then be secured within the receptacle 704 along with the cartridge 700 As shown in FIG. 7, the single cylindrical smart cartridge 700 may be directly threaded into the proximal tibia 312 distal to the cortical button 306. The smart cartridge 700 may have a radome 724 (see FIGS. 8A-8B) at the distal insertion end of the cartridge 700, such that the antenna resides within cancellous bone. The smart cartridge 700 may not have a portion extending out of the receptacle, such that the cartridge does not project into softtissue. The receptacle 704 may have dimensions that are about the same or only slightly larger than the housing of the smart cartridge 700, such that the smart cartridge 700 may fit within the receptacle with little to no empty space between the cartridge and the walls of the receptacle to prevent undesirable migration of the cartridge within the receptacle.

[0100] FIG. 8 illustrates two embodiments of the smart cartridge 700 shown in FIG. 7, specifically a "tall" cartridge and a "short" cartridge. The intelligent implant of FIGS. 7 and 8 does not include a separate securing device for the smart cartridge of FIG. 7 because the housing of the cartridge includes features, e.g., threads 720, on the exterior surface of the housing, that can be used to secure the cartridge 700 directly in the receptacle. The cartridge may have dimensions suitable for implantation near an ACL repair or reconstruction. The short cartridge may have a lower insertion portion with a diameter less than or equal to 11 mm, less than or equal to 10 mm, less than or equal to 9 mm, or ranges therebetween. The short cartridge may have a larger cross-sectional diameter than the tall cartridge. The tall cartridge may have a lower insertion portion with a diameter less than or equal to 8 mm, less than or equal to 7 mm, less than or equal to 6 mm, or ranges therebetween. The short cartridge may have an flange portion with a diameter less than or equal to 14 mm, less than or equal to 13 mm, less than or equal to 12 mm, or ranges therebetween. The tall cartridge may have a flange portion with a diameter less than or equal to 10 mm, less than or equal to 9 mm, less than or equal to 8 mm, or ranges therebetween. The thickness of the flange may be the same for each of the short and tall cartridges. The thickness of the flange may be at least about 1.5 mm and / or less than or equal to 5 mm, for example less than or equal to 2 mm. The length of the short cartridge may be at least about 40 mm and / or less than or equal to 50 mm, for example less than or equal to 50 mm, less than or equal to 45 mm, or less than or equal to 40 mm. The length of the tall cartridge may be at least about 50 mm and / or less than or equal to 60 mm, for example less than or equal to 60 mm, or less than or equal to 50 mm. The length of the radome 324 may be equal for each of the short and tall cartridges. The radome may have a length less than or equal to 8 mm, less than or equal to 7 mm, or less than or equal to 6 mm or ranges therebetween.

[0101] FIG. 13 illustrates a intelligent implant comprising a smart cartridge 1300 with a plate portion 1316. The smart cartridge 1300 may be implanted into a receptacle 1304 of a host bone. For example, as shown in FIG. 13, the host bone may be a tibia 312. The plate portion 1316 may be configured to be located outside of the receptacle 1304 and extend along thehost bone when the cartridge is implanted into the receptacle. The electronics assembly of the smart cartridge 1300 may be housed within the plate portion 1316 of the cartridge 1300. The plate portion 1316 may comprise a bottom surface. The bottom surface may interface with a surface of the host bone. The smart cartridge 1300 may comprise an insertion portion 1312 extending from the bottom surface of the plate portion 1316. The insertion portion 1312 may have a form factor that fits into the receptacle 1304, e.g., a cylindrical form factor. As shown in FIG. 13, the intelligent implant may comprise a separate securing insert 1308 to secure the smart cartridge 1300 within the receptacle 1304. The cartridge may comprise a coupling feature, e.g., threads, snap ring, etc., to couple the cartridge to the separate securing insert 1308. In some embodiments, the insertion portion 1312 may comprise a surface feature that allows for the securing of the smart cartridge 1300 partially within the receptacle 1304. For example, the insertion portion 1312 may comprise external threads.

[0102] An intelligent implant may be configured to be implanted at least partially within a receptacle of a host bone to secure a tensioned element used for an ACL surgery. As discussed elsewhere herein, an ACL surgery may use a tensioned element. The tensioned element may be an ACL graft used for an ACL-R. In some embodiments, the tensioned element may be a rope or a suture used for an ACL repair or ACL-R. The tensioned element may be secured within a receptacle of a bone associated with the knee, such as a tibia. The receptacle may be a through hole configured to receive an ACL graft in an ACL-R. In some embodiments, the receptacle may be formed in the tibia distal to the site of the ACL surgery. The intelligent implant may comprise a smart cartridge and a securing feature. The securing feature may be a separate insert coupled to the smart cartridge. In some embodiments, the securing feature may include a surface feature formed on the housing of the smart cartridge.

[0103] FIG. 11 illustrates an intelligent implant comprising a smart cartridge 1100 and configured to be implanted in a through hole formed for an ACL-R. The ACL-R may require drilling through holes 1104A, 1104B in both of the tibia 312 and the femur 310, respectively, around the knee 316 to form a pathway for an ACL graft 1102. The implant may comprise a separate securing insert 1108 coupled to the smart cartridge 1100. The implant may have a form factor that provides a force-fit with the ACL graft and the through hole 1104A receptacle to secure the ACL graft 1102. As shown in FIG. 11, the implant may comprise a securing insert 1108 having separate channels extending within the insert for receiving one or both of the ACL graft 1102 and the smart cartridge 1100. For example, as shown by the cross-sectionalview of the securing insert in FIG. 11, the securing insert 1108 may comprise a first channel 1112 for receiving the ACL graft and a second channel 1110 for receiving the smart cartridge 1100. The securing insert 1108 may also have external securing threads. For example, the securing insert may comprise an interference screw. The smart cartridge may be integrated with the interference screw. For example, the smart cartridge may be coupled to or replace the proximal end of the interference screw. In some embodiments, the housing of the smart cartridge may have a form factor and / or surface feature that mimics an interference screw, such that the smart cartridge secures itself and the tensioned element within the receptacle without a separate securing insert.

[0104] FIG. 12 illustrates an intelligent implant 1200 comprising a smart cartridge and configured to be implanted in a receptacle 1204 of a host bone. The receptacle 1204 may be formed by drilling into a solid portion of the host bone near the site of a joint surgery. The joint may be a knee 316 between a femur 310 and a tibia 312. For example, as shown in FIG. 12, the receptacle 504 is located in the tibia 312 distal to a cortical button 306 used for an ACL surgery. The ACL surgery may use a tensioned element to support the ACL. The tensioned element may comprise a rope or a suture. The tensioned element may extend out of the tibia from the ACL site. The tensioned element may be secured within the receptacle 1204 by the implant. For example, as shown in FIG. 12, the rope 1202 may be configured to wrap around the insertion end of the implant 1200. The implant 1200 and the rope 1202 may be implanted together into the receptacle 1204. The implant 1200 may comprise a surface feature, e.g., threads, to secure the implant at least partially within the receptacle 1204. The securement of the implant 1200 may also secure the rope 1202 within the receptacle 1204. The implant 1200 may have a form factor that provides a force-fit within the receptacle. The implant 1200 may also have external securing threads (not shown). For example, the implant 1200 may comprise an interference screw. The smart cartridge may be integrated with the interference screw. For example, the smart cartridge may be coupled to or replace the proximal end of the interference screw. In some embodiments, the housing of the smart cartridge may have a form factor and / or surface feature that mimics an interference screw, such that the smart cartridge secures itself and the tensioned element within the receptacle without a separate securing insert.

[0105] A method of implanting an intelligent implant into a receptacle of a host bone for monitoring a joint surgery is disclosed. The method may include forming a receptacle in a hostbone associated with a joint. The receptacle may be formed by drilling into the host bone. The method may further include inserting an intelligent implant into the receptacle. The intelligent implant may comprise a smart cartridge and a securing feature. The securing feature may include a separate securing insert. The method may include coupling the smart cartridge to the securing insert by a coupling feature. The coupling may occur before insertion of either of the smart cartridge or the securing insert, or may occur after insertion of one of the smart cartridge or the securing insert into the receptacle. In some embodiments, the intelligent implant may not include a separate securing device with the smart cartridge, and the securing feature may comprise a surface feature on the surface of the housing of the smart cartridge. The method may further include securing the implant in the receptacle by the securing feature. The securing feature may include threads, a retaining ring, locking tabs, keys, flanges, etc.

[0106] A method of implanting an intelligent implant into a receptacle of a host bone for monitoring an ACL surgery is disclosed. The method may include forming a receptacle in a host bone for an ACL surgery. The receptacle may be formed by drilling into the host bone. For example, the receptacle may be formed by drilling a through hole into the tibia to receive an ACL graft. The method may further include inserting an intelligent implant into the receptacle to secure a tensioned element used for the ACL surgery. The tensioned element may comprise a ACL graft used in an ACL-R, or a rope or suture used for ACL-R or primary ACL repair.

[0107] Although several embodiments are described herein with respect to monitoring of an ACL surgery by implanting a smart cartridge in a tibia, the disclosed features may be used for smart cartridges implanted in other bones configured to monitor other joint surgeries, such as a smart cartridge implanted in a bone near the shoulder to monitor rotator cuff repair, etc. Subcutaneous Implantation of Smart Cartridge

[0108] Disclosed herein are smart cartridges configured to be subcutaneously implanted near a bone associated with a joint. The smart cartridge may be implanted near a bone associated with a joint that is undergoing surgery to monitor recovery from the joint surgery. The smart cartridge may be implanted such that the cartridge extends along the bone associated with the joint. The smart cartridge may collect kinematic data indicative of a laxity and / or flexion / extension of a joint. For example, a smart cartridge may be implanted along the tibia to monitor recovery of an ACL surgery. The subcutaneously implanted smart cartridge mayinclude a rechargeable battery. The smart cartridge may be removable or retrievable after implantation. The smart cartridge may be configured to have a life cycle of at least one year.

[0109] Referring to FIG. 15, a smart cartridge may be subcutaneously implanted in the zone indicated by the dashed boundary to monitor a knee surgery, such as an ACL surgery. FIG. 15 illustrates a tibia 1504, a fibula 1506, a proximal tibiofibular joint 1502, a distal tibiofibular joint 1508, a lateral malleolus 1510, and a interosseous membrane 1512. The smart cartridge may be implanted between the tibia 1504 and the fibula 1506. The smart cartridge may be implanted in a muscle pocket along the interosseous membrane 1512. The smart cartridge may be implanted in a specific placement distal to the proximal tibiofibular joint 1502. The smart cartridge may be implanted below a proximal opening 1514 of the interosseous membrane through which the anterior tibial artery passes. The smart cartridge may be implanted anterior to the common fibular nerve. The specific placement of the smart cartridge may prevent pain, disruption of blood flow, or impingement of surrounding nerves. The smart cartridge may be implanted between the interosseous membrane and the flexor digitorum longus. FIG. 18 illustrates a cross-sectional view of a leg. The leg comprises the tibia 1802, the fibula 1808, the anterior compartment 1804, the lateral compartment 1806, the deep posterior compartment 1810, the superficial posterior compartment 1814, and the fascia enclosing the compartments 1812. As shown in FIG. 18, the smart cartridge may be implanted in an anterior compartment 1804 of the leg. In some embodiments, the smart cartridge may be implanted in a posterior compartment 1810 / 1814 or a lateral compartment 1806 of the leg. The smart cartridge may be implanted such that a major axis of the cartridge extends along a longitudinal axis of the tibia.

[0110] The smart cartridge may be shaped as a capsule having a spheroid shape, as shown in FIG. 14. The smart cartridge may include a stabilizing feature, such as a suture, staking, or other anchor system. The smart cartridge may include an outer liner or mesh configured to cover the smart cartridge during and after implantation. The liner or mesh may be configured to secure the smart cartridge in a desired position by allowing for inner growth of tissue over time. The mesh may be comprised of a lubricious material, e.g., Teflon, silk, Delrin, nylon, etc. A secondary lubricious coating may be applied to the mesh by dipping or spraying as the mesh is woven, or may be pre-applied to the thread used for manufacturing the mesh.

[0111] A method of subcutaneously implanting a smart cartridge for monitoring an ACL surgery is disclosed. The method may comprise loading the smart cartridge into a deliverydevice. The method may further include marking an initial location on the skin of the leg with a small incision for control of insertion. The initial location may depend on the specific muscle pocket set to receive the smart cartridge, e.g. on a posterior side if the cartridge is implanted in a posterior leg compartment. The method may further include puncturing below the subcutaneous and hypodermis layers above the interosseous membrane with the delivery device. The smart cartridge may then be implanted in a muscle pocket adjacent the interosseous membrane using the delivery device. The smart cartridge may be configured to monitor recovery of an ACL surgery, e.g., an ACL-R, by collecting kinematic data indicative of laxity, flexion, and / or extension of a knee. The smart cartridge may have a short-term lifespan of about 1 to 2 years, corresponding to the recovery timeline of an ACL surgery.

[0112] FIG. 16 illustrates a delivery device 1600 for subcutaneous implantation of a smart cartridge. The delivery device may comprise a base 1604 and adhesive. The base 1604 may enable control of a location for a barrel-plunger assembly on top of the skin and maintain the position of the assembly after a medical person identifies a pocket location for insertion. The delivery device 1600 may comprise a collar 1608 that stabilizes the barrel 1612 and plunger 1620 by setting a through cannula for the insertion of the plunger 1620 to a set position within the through hole in the base 1604 and leading through the skin. The delivery device 1600 may comprise a barrel 1612. The barrel 1612 may act as the outer body for the control of the plunger 1620 action to insert the cartridge below the skin and into a muscle pocket. The barrel 1612 may also provide the connection to the base 1604 and adhesive for alignment to the implantation location in the leg. The delivery device 1600 may comprise a plunger 1620. The plunger 1620 may control the lance puncture and depth, the lance being loaded with the sensor, to create the specific pocket for the cartridge. The delivery device 1600 may comprise a Tuoghy-Borst lock 1616 to maintain the plunger 1620 in position and the loaded cartridge in the needle lumen until ready for implantation. The delivery device 1600 may comprise a push rod 1624. Once the plunger 1620 has finished its motion for the lance to create the pocket for the cartridge— the push rod 1624 may be engaged. The Tuoghy Borst lock 1616 may be opened and the push rod 1624 may be pressed down to move the rod through the needle lumen and push the sensor out of the needle body and into the muscle pocket.

[0113] FIG. 17 illustrates steps for using the delivery device 1600. The body and adhesive may be placed on the implantation location. The plunger may be moved down 1704 to lance the skin and create a muscle pocket in the leg to receive the smart cartridge. The push rod maythen be pushed down 1708 to push the smart cartridge out of the needle inner lumen and into the muscle pocket. The collar may be pulled back 1712 to extract the needle and the push rod to a position outside of the skin.

[0114] Although several embodiments are described herein with respect to monitoring of an ACL surgery in the knee, the disclosed features may be used for subcutaneously implanted smart cartridges configured to monitor other joint surgeries, such as rotator cuff repair, knee replacement, hip replacement, etc.Form Factors

[0115] As previously noted, "form factor" as used herein refers to physical characteristics, e.g., three-dimensional shape and size, of a structure or an empty space. The smart cartridge 100 of FIGS. 1A-2B is characterized by a generally cylindrical form factor having circular crosssections along its length. A cylindrical form factor with circular cross-sections (as opposed to a block form factor with square or rectangular cross-sections) may provide the smallest form factor for a given volume. While the cylindrical form factor with circular cross-section can provide the smallest form factor, which may be a necessary consideration in selecting the form factor of the smart cartridge, form factors having non-circular cross-sections may alternatively be employed. In some instances, a form factor having non-circular crosssections, also referred to herein as "a non-circular form factor", may reduce the number of orientations in which the smart cartridge may fit into the receptacle of a host bone and thereby assist in creating a known and fixed orientation of the smart cartridge in the bone. For example, a smart cartridge with an oval form factor may have only a single orientation which will fit within the receptacle of the bone, where that single orientation effectively locks the smart cartridge in place, i.e., the cartridge can only fit in the bone in only a single orientation, and cannot rotate and thereby change orientation after being positioned in the receptacle, thus providing for a known and constant alignment of the cartridge in the bone.

[0116] Other form factors may also be employed for similar purposes, e.g., triangle, square, rectangle, kite, trapezoid, parallelogram and rhombus are suitable form factors for the smart cartridge and corresponding receptacle of the host bone. Depending on the design of the form factor, the smart cartridge may fit into the receptacle in only one, or two, or three, or four, or five, or six, etc. orientations, thus reducing the number of possible orientations compared to those provided by a circular cross-section form factor. In some embodiments, the form factor may have a plane of symmetry, while in other embodiments the form factormay not have a plane of symmetry.

[0117] The form factor may or may not have the same cross-section along its entire length where the housing of the smart cartridge abuts the interior surface of the receptacle of the host bone. For example, the form factor may have a circular cross section toward the proximal end of the cartridge / receptacle abutment but may change to having a non-circular cross section toward the distal end of the cartridge / receptacle abutment. The non-circular distal end of the cartridge / receptacle abutment may provide for only a single orientation whereby the smart cartridge can be seated in the receptacle. Alternatively, the non-circular distal end of the cartridge / receptacle abutment may provide for only two, or three, or four, or five, or six, etc. possible orientations when the smart cartridge is seated within the bone receptacle.

[0118] The non-circular distal end of the cartridge / receptacle abutment may provide for stability, or enhanced stability, of the cartridge / receptacle alignment, in the event that the cartridge may not rotate within the receptacle due the rotation causing a surface of the cartridge to abut against an immovable surface of the bone. As one example, the distal end of the cartridge may have a cross section in the shape of a plus sign, and the distal end of the receptacle may have a cross section that is the complement of a plus sign, so that the distal end of the cartridge fits securely into the distal end of the receptacle and the entirely of the cartridge cannot rotate within the receptacle. The four arms of the plus sign need not be exactly the same size or exactly the same shape, so that there is but a single orientation in which the cartridge fully seats in the receptacle.Smart Cartridge Electronics

[0119] With reference to FIG. 9A, a smart cartridge 2000 includes an electronics assembly 2010, a battery 2012 or other suitable implantable power source, an antenna 2030, and one or more external sensors 2040. The electronics assembly 2010 includes a fuse 2014, switches 2016 and 2018, a clock generator and clock and power management circuit 2020, an inertial measurement unit (IMU) 2022 having accelerometers and gyroscopes, a memory circuit 2024, a radio-frequency (RF) transceiver 2026, an RF filter 2028 and a controller 2032 with at least two joint-specific modules, e.g., a knee module 2050, a hip module 2052, and a shoulder module 2054. Although not shown in FIG. 9A, the electronics assembly 2010 may also include an accelerometer that functions independent of the accelerometers of the IMU. Examples of some of these components are described elsewhere in this application and in PCT Publication

[0120] The battery 2012 can be any suitable battery, such as a Lithium Carbon Monofluoride (LiCFx) battery, or other storage cell configured to store energy for powering the electronics assembly 2010 for an expected lifetime (e.g., 5 - 25+ years) of the kinematic implant.

[0121] The fuse 2014 can be any suitable fuse (e.g., permanent) or circuit breaker (e.g., resettable) configured to prevent the battery 2012, or a current flowing from the battery, from injuring the patient and damaging the battery and one or more components of the electronics assembly 2010. For example, the fuse 2014 can be configured to prevent the battery 2012 from generating enough heat to burn the patient, to damage the electronics assembly 2010, to damage the battery, or to damage structural components of the kinematic implant.

[0122] The switch 2016 is configured to couple the battery 2012 to, orto uncouple the battery from, the IMU 2022 in response to a control signal from the controller 2032. For example, the controller 2032 may be configured to generate the control signal having an open state that causes the switch 2016 to open, and, therefore, to uncouple power from the IMU 2022, during a sleep mode or other low-power mode to save power, and, therefore, to extend the life of the battery 2012. Likewise, the controller 2032 also may be configured to generate the control signal having a closed state that causes the switch 2016 to close, and therefore, to couple power to the IMU 2022, upon "awakening" from a sleep mode or otherwise exiting another low-power mode. Such a low-power mode may be for only the IMU 2022 or for the IMU and one or more other components of the implantable.

[0123] The switch 2018 is configured to couple the battery 2012 to, orto uncouple the battery from, the memory circuit 2024 in response to a control signal from the controller 2032. For example, the controller 2032 may be configured to generate the control signal having an open state that causes the switch 2018 to open, and, therefore, to uncouple power from the memory circuit 2024, during a sleep mode or other low-power mode to save power, and, therefore, to extend the life of the battery 2012. Likewise, the controller 2032 also may be configured to generate the control signal having a closed state that causes the switch 2018 to close, and therefore, to couple power to the memory circuit 2024, upon "awakening" from a sleep mode or otherwise exiting another low-power mode. Such a low-power mode may be for only the memory circuit 2024 or for the memory circuit and one or more other components of the electronics assembly 2010.

[0124] The clock and power management circuit 2020 can be configured to generate a clock signal for one or more of the other components of the electronics assembly 2010, and can be configured to generate periodic commands or other signals (e.g., interrupt requests) in response to which the controller 2032 causes one or more components of the implantable circuit to enter or to exit a sleep, or other low-power, mode. The clock and power management circuit 2020 also can be configured to regulate the voltage from the battery 2012, and to provide a regulate power-supply voltage to some or all of the other components of the electronics assembly 2010.

[0125] The IMU 2022 has a frame of reference with coordinate x, y, and z axes, and can be configured to measure, or to otherwise quantify, acceleration that the IMU experiences along each of the x, y, and z axes, and angular velocity that the IMU experiences about each of the x, y, and z axes. Such a configuration of the IMU 2022 is at least a six-axis configuration, because the IMU 2022 measures six unique quantities, accx(t), accy(t), accz(t), Qx(t), Qy(t), and Qz(t). Alternatively, the IMU 2022 can be configured in a nine-axis configuration, in which the IMU can use gravity to compensate for, or to otherwise correct for, accumulated errors in accx(t), accy(t), accz(t), Qx(t), Qy(t), and Qz(t). But in an embodiment in which the IMU measures acceleration and angular velocity over only short bursts (e.g., 0.10 - 100 seconds(s)), for many applications accumulated error typically can be ignored without exceeding respective error tolerances.

[0126] The IMU 2022 can include a respective analog-to-digital converter (ADC) for each of the x, y, and z accelerometers and gyroscopes. Alternatively, the IMU 2022 can include a respective sample-and-hold circuit for each of the x, y, and z accelerometers and gyroscopes, and as few as one ADC that is shared by the accelerometers and gyroscopes. Including fewer than one ADC per accelerometer and gyroscope can decrease one or both of the size and circuit density of the IMU 2022, and can reduce the power consumption of the IMU. But because the IMU 2022 includes a respective sample-and-hold circuit for each accelerometer and each gyroscope, samples of the analog signals generated by the accelerometers and the gyroscopes can be taken at the same or different sample times, at the same or different sample rates, and with the same or different output data rates (ODR).

[0127] As mentioned above, the electronics assembly 2010 may also include an accelerometer that functions independent of the accelerometers of the IMU. This accelerometer may be configured to monitor acceleration in a low power state. Theaccelerometer may be a single axis or multi-axis accelerometer, and in one embodiment is a triaxial accelerometer. Based on acceleration signals it senses, this accelerometer can detect motion events. For example, the accelerometer can be configured to detect simple motion events, such as footsteps or shoulder swings, and to count such detections. The accelerometer can be configured to detect significant motion, such as a walking motion or arm swinging motion. The accelerometer may be configured to provide a wake-up signal to the controller 1032 when significant motion is detected.

[0128] The memory circuit 2024 can be any suitable nonvolatile memory circuit, such as EEPROM or FLASH memory, and can be configured to store data written by the controller 2032, and to provide data in response to a read command from the controller.

[0129] The RF transceiver 2026 can be a conventional transceiver that is configured to allow the controller 2032 (and optionally the fuse 2014) to communicate with a base station configured for use with the kinematic implantable device. For example, the RF transceiver 2026 can be any suitable type of transceiver (e.g., Bluetooth, Bluetooth Low Energy (BTLE), and WiFi®), can be configured for operation according to any suitable protocol (e.g., MICS, ISM, Bluetooth, Bluetooth Low Energy (BTLE), and WiFi®), and can be configured for operation in a frequency band that is within a range of 1 MHz - 5.4 GHz, or that is within any other suitable range.

[0130] The RF filter 2028 can be any suitable bandpass filter, such as a surface acoustic wave (SAW) filter or a bulk acoustic wave (BAW) filter. In some embodiment, the RF filter 1028 includes multiple filters and other circuitry to enable dual-band communication. For example, the RF filter 1028 may include a bandpass filter for communications on a MICS channel, and a notch filter for communication on a different channel, such as a 2.45GHz.

[0131] The antenna 2030 can be any antenna suitable for the frequency band in which the RF transceiver 2026 generates signals for transmission by the antenna, and for the frequency band in which a base station generates signals for reception by the antenna.

[0132] The external sensors 2040 may include, for example, chemistry sensors (e.g., for blood and / or other fluids), metabolic sensors (e.g., for blood and / or other fluids), analyte sensors (e.g., for glucose), pH sensors, temperature sensors, fluid pressure sensors, fluid volume sensors, contact sensors, and position sensors. The external sensors 2040 may be located on the exterior of the cap 116 of the antenna assembly 112 to provide contact with biological fluid or tissue, or exposure to an intrabody space around the antenna assembly. The externalsensors 2040 may couple to the electronics assembly 2010 through a feedthrough through the cap 116.

[0133] The controller 2032, which can be any suitable microcontroller or microprocessor, is configured to control the configuration and operation of one or more of the other components of the electronics assembly 2010. For example, different modules of the controller 2032 are configured to control the IMU 2022 to take measurements of movement of the host bone with which the smart cartridge 2000 is integrated, to quantify the quality of such measurements (e.g., is the measurement "good" or "bad"), to store measurement data generated by the IMU in the memory circuit 2024, to generate messages that include the stored data, to packetize the messages, to provide the message packets to the RF transceiver 2026 for transmission to an external device, e.g. a base station.

[0134] The controller 2032 may be configured to execute commands received from an external device via the antenna 2030, the RF filter 2028, and the RF transceiver 2026. For example, the controller 2032 can be configured to receive configuration data from a base station, and to provide the configuration data to the component of the electronics assembly 2010 to which the base station directed the configuration data. If the base station directed the configuration data to the controller 2032, then the controller is configured to configure itself in response to the configuration data. The controller 2032 may also be configured to execute data sampling by the IMU 2022 in accordance with one or more programmed sampling schedules, or in response to an on-demand data sampling command received from a base station.

[0135] In some embodiments, the controller 2032 includes a knee module 2050, a hip module 2052, and a shoulder module 2054. Each of these modules may comprise firmware and / or software configured to operate the smart cartridge 2000 is a manner specific to the host bone in which the smart cartridge is integrated. The knee module 2050 is configured to operate the IMU 2022 to obtain kinematic information associated with motion of a knee implant. The knee module 2050 include two submodules, one that operate the IMU 2022 to obtain kinematic information associated with motion of a left knee, and a second that operate the IMU 2022 to obtain kinematic information associated with motion of a right knee.

[0136] The hip module 2052 is configured to operate the IMU 2022 to obtain kinematic information associated with motion of a hip implant. The hip module 2052 include two submodules, one that operate the IMU 2022 to obtain kinematic information associated withmotion of a left hip implant, and a second that operate the IMU 2022 to obtain kinematic information associated with motion of a right hip implant.

[0137] The shoulder module 2054 is configured to operate the IMU 2022 to obtain kinematic information associated with motion of a shoulder implant. The shoulder module 2054 include two submodules, one that operate the IMU 2022 to obtain kinematic information associated with motion of a left shoulder implant, and a second that operate the IMU 2022 to obtain kinematic information associated with motion of a right shoulder implant.

[0138] Depending on the type of host bone in which the smart cartridge 2000 is integrated, one submodule of these joint-specific modules 2050, 2052, 2054 is activated, while the other submodules are disabled.Operation of Smart Cartridge

[0139] Continuing with FIG. 9A, operation of a smart cartridge 2000 is now described. The fuse 2014, which is normally electrical closed, is configured to open electrically in response to an event that can injure the patient in which the intelligent implant 2000 resides, or damage the battery 2012 of the intelligent implant if the event persists for more than a safe length of time. An event in response to which the fuse 2014 can open electrically includes an overcurrent condition, an overvoltage condition, an overtemperature condition, an over- current-time condition, and over-voltage-time condition, and an over-temperature-time condition. An overcurrent condition occurs in response to a current through the fuse 2014 exceeding an overcurrent threshold. Likewise, an overvoltage condition occurs in response to a voltage across the fuse 2014 exceeding an overvoltage threshold, and an overtemperature condition occurs in response to a temperature of the fuse exceeding a temperature threshold. An over-current-time condition occurs in response to an integration of a current through the fuse 2014 over a measurement time window (e.g., ten seconds) exceeding a current-time threshold, where the window can "slide" forward in time such that the window always extends from the present time back the length, in units of time, of the window. Alternatively, an over-current-time condition occurs if the current through the fuse 2014 exceeds an overcurrent threshold for more than a threshold time.

[0140] Similarly, an over-voltage-time condition occurs in response to an integration of a voltage across the fuse 2014 over a measurement time window, and an over-temperature- time condition occurs in response to an integration of a temperature of the fuse over a measurement time window. Alternatively, an over-voltage-time condition occurs if thevoltage across the fuse 2014 exceeds an overvoltage threshold for more than a threshold time, and an over-temperature-time condition occurs if a temperature associated with the fuse 2014, battery 2012, or electronics assembly 2010 exceeds an overtemperature threshold for more than a threshold time. But even if the fuse 2014 opens, thus uncoupling power from the electronics assembly 2010, the mechanical and structural components of the smart cartridge 2000 is associated are still fully operational. For example, if the smart cartridge 2000 is a knee prosthesis, then the knee prosthesis still can function fully as a patient's knee; abilities lost, however, are the abilities to detect and to measure kinematic motion of the prosthesis, to generate and to store data representative of the measured kinematic motion, and to provide the stored data to a base station or other destination external to the kinematic prosthesis.

[0141] In some embodiments, a joint-specific module 2050, 2052, 2054 is configured to cause the IMU 2022 to measure, in response to a movement of the smart cartridge 2000, movement of a joint over a window of time (e.g., ten seconds, twenty seconds, one minute), to determine if the measured movement is a qualified movement, to store the data representative of a measured qualified movement, and to cause the RF transceiver 2026 to transmit the stored data to a base station or other source external to the prosthesis.

[0142] For example, in the case of a host knee implant, the knee module 2050 may control the operation of the IMU 1022 such that the IMU begins sampling the sense signals output from its one or more accelerometers and one or more gyroscopes in response to a detected movement within a respective time period (day), and the knee module 2050 can analyze the samples to determine if the detected movement is a qualified movement. Further in example, the IMU 2022 can detect movement in any conventional manner, such as by movement of one or more of its one or more accelerometers. In response to the IMU 2022 notifying knee module 2050 of the detected movement, the knee module can correlate the samples from the IMU to stored accelerator and gyroscope samples generated with a computer simulation or while the patient, or another patient, is walking normally, and can measure the time over which the movement persists (the time equals the number of samples times the inverse of the sampling rate). If the samples of the accelerator and gyroscope output signals correlate with the respective stored samples, and the time over which the movement persists is greater than a threshold time, then the knee module 2050 effectively labels the movement as a qualified movement.

[0143] In response to determining that the movement is a qualified movement, the knee module 2050 stores the samples, along with other data, in the memory circuit 2024, and may disable the IMU 2022 until the next time period (e.g., the next day or the next week) by opening the switch 2016 to extend the life of the battery 2012. The clock and power management circuit 2020 can be configured to generate periodic timing signals, such as interrupts, to commence each time period. For example, the knee module 2050 can close the switch 2016 in response to such a timing signal from the clock and power management circuit 2020. Furthermore, the other data can include, e.g., the respective sample rate for each set of accelerometer and gyroscope samples, a respective time stamps indicating the time at which the IMU 2022 acquired the corresponding sets of samples, the respective sample times for each set of samples, an identifier (e.g., serial number) of the implantable prosthesis, and a patient identifier (e.g., a number or name). The volume of the other data can be significantly reduced if the sample rate, time stamp, and sample time are the same for each set of samples (i.e., samples of signals from all accelerometers and gyroscopes taken at the same times at the same rate) because the header includes only one sample rate, one time stamp, and one set of sample times for all sets of samples. Furthermore, the knee module 2050 can encrypt some or all of the data in a conventional manner before storing the data in the memory circuit 2024. For example, the knee module 2050 can encrypt some or all of the data dynamically such that at any given time, the same data has a different encrypted form than if encrypted at another time.

[0144] The stored data samples of the signals that the one or more accelerometers and one or more gyroscopes of the IMU 2022 generate can provide clues to the condition of the implantable prosthesis. For example, one can analyze the data samples (e.g., with a remote server such as a cloud server) to determine whether a surgeon implanted the prosthesis correctly, to determine the level(s) of instability and degradation that the implanted prosthesis exhibits at present, to determine the instability and degradation profiles over time, and to compare the instability and degradation profiles to benchmark instability and degradation profiles developed with stochastic simulation or data from a statistically significant group of patients.

[0145] The stored data samples of the signals that the one or more accelerometers and one or more gyroscopes of the IMU 2022 generate can provide detailed information about the gait of the host during ambulation, where characterization of gait and changes therein canprovide clues to the physical and / or mental condition of the host. In one aspect the data is collected and analyzed to characterize a host's gait and in particular to look for abnormal gait that is indicative of a health concern, and changes therein over time. Some exemplary gait abnormalities that may be identified with the smart cartridge and related systems and methods as described herein include: antalgic gait, which is caused by pain, and may be observed as limping; propulsive gait which may be indicative of Parkinson's disease; scissors gait or crouching gait, either of which may be indictive of cerebral palsy, spastic gait which may be indicative of hemiplegia or multiple sclerosis or cerebral palsy; steppage gait which may be indicative of muscle atrophy or a peroneal nerve injury; waddling gait which may be indicative of progressive muscular dystrophy or hip dislocation; ataxic gait which may be indicative of cerebellar degeneration; shuffling gait which may be indicative of nerve damage; lurching gait which may be indicative of paralysis or weakness of the gluteus area.

[0146] In one embodiment the present disclosure provides methods of monitoring a movement of a host with a smart cartridge, where the host has a neurological disorder, such as Parkinson's disease, Alzheimer's disease, Huntington's Disease, cerebellar ataxia, multiple sclerosis, peripheral neuropathy, myelopathy. In one embodiment the present disclosure provides methods of monitoring movement of a host with smart cartridge, where the host has a neurological disorder brought on by a stroke or a spinal cord injury.

[0147] The sampling rate, output data rate (ODR), and sampling frequency of the IMU 2022 can be configured to any suitable values. For example, the knee module 2050 may control the operation of IMU 2022 so that the sampling rate may be fixed to any suitable value such as at 3200 Hz, the ODR, which can be no greater than the sampling rate and which is generated by "dropping" samples periodically, can be any suitable value such as 800 Hz, and the sampling frequency (the inverse of the interval between sampling periods) for qualified events can be any suitable value, such as twice per day, once per day, once per every 2 days, once per week, once per month, or more or less frequently. And sampling rate or ODR can be varied depending on the type of event being sampled. For example, to detect that the patient is walking without analyzing the patient's gait or the implant for instability or wear, the sampling rate or ODR can be 200 Hz, 25 Hz, or less. Therefore, such a low-resolution mode can be used to detect a precursor (a patient taking steps with a knee prosthesis) to a qualified event (a patient taking at least ten consecutive steps) because a "search" for a qualified event may include multiple false detections before the qualified even is detected. By using a lowersampling rate or ODR, the IMU 1022 saves power while conducting the search, and increases the sampling rate or the ODR (e.g., to 800 Hz, 1600, or 3200 Hz) only for sampling a detected qualified event so that the accelerator and gyroscope signals have sufficient sampling resolution for analysis of the samples for, e.g., instability and wear of the prosthesis.

[0148] While the foregoing speaks in terms of the knee module 2050 of the smart cartridge, similar operations may be performed by the hip module 2052 or the shoulder module 2054. Systems with Intelligent Implants

[0149] An intelligent implant system includes one or more of 1) a sensor that detects and / or measures the functioning of the implant and / or the immediate environment around the implant and / or the activity of the patient, 2) memory that stores data from that detection and / or measuring, 3) an antenna that transmits that data, 4) a base station that receives the data generated by the sensor and may transmit the data and / or analyzed data to a cloudbased location, 5) a cloud-based location where data may be stored and analyzed, and analyzed data may be stored and / or further analyzed, 6) a receiving terminal that receives output from the cloud-based location, where that receiving terminal may be accessed, e.g., by a health care professional or an insurance company or the manufacturer of the implant, and the output may identify the status of the implant and / or the functioning of the implant and / or the status of the patient who has received the implant, and may also provide recommendations for addressing any concerns raised by analysis of the original data. A smart cartridge as described herein may provide the sensor and optionally other features such as memory and antenna of the intelligent implant system.

[0150] FIG. 10 illustrates a context diagram of an operation environment 2100. In the environment, a host bone having an integrated smart cartridge 100 (referred to from hereon as an intelligent implant 2102) is implanted by a medical practitioner in the body of a patient The intelligent implant 2102 is arranged to collect data including operational data of the device along with kinematic data associated with particular movement of the patient or particular movement of a portion of the patient's body, for example, one of the left knee or the right knee of the patient. The intelligent implant 2102 communicates with one or more base stations or one or more smart devices during different stages of monitoring the patient.

[0151] For example, in association with a medical procedure, an intelligent implant 2102 is implanted in the patient's body. Coetaneous with the medical procedure, the intelligent implant 2102 communicates with an operating room base station during which theappropriate one of the knee module 2050, the hip module 2052, and the shoulder module 2054 is activated. Subsequently, after sufficient recovery from the medical procedure, the patient returns home wherein the intelligent implant 2102 is arranged to communicate with a home base station 2104. At other times, the intelligent implant 2102 is arranged to communicate with a doctor office base station. The intelligent implant 2102 communicates with each base station via a short-range network protocol, such as the medical implant communication service (MICS), the medical device radio communications service (MedRadio), or some other wireless communication protocol suitable for use with the intelligent implant 2102.

[0152] The intelligent implant 2102 includes one or more sensors to collect information and kinematic data associated with the use of the body part to which the intelligent implant 2102 is associated. For example, the intelligent implant 2102 may include an inertial measurement unit that includes gyroscope(s), accelerometer(s), pedometer(s), or other kinematic sensors to collect acceleration data for the medial / lateral, anterior / posterior, and anterior / inferior axes of the associated body part; angular velocity forthe sagittal, frontal, and transvers planes of the associated body part; force, stress, tension, pressure, duress, migration, vibration, flexure, rigidity, or some other measurable data.

[0153] The intelligent implant 2102 collects data at various different times and at various different rates during a monitoring process of the patient. In some embodiments, the intelligent implant 2102 may operate in a plurality of different phases over the course of monitoring the patient so that more data is collected soon after the intelligent implant 2102 is implanted into the patient, but less data is collected as the patient heals and thereafter.

[0154] In one non-limiting example, the monitoring process of the intelligent implant 2102 may include three different phases. A first phase may last for four months where kinematic data is collected once a day for one minute, every day of the week. After the first phase, the intelligent implant 2102 transitions to a second phase that lasts for eight months and collects kinematic data once a day for one minute, two days a week. And after the second phase, the intelligent implant 2102 transitions to a third phase that lasts for nine years and collects kinematic data one day a week for one minute for the next nine years. Of course, the time periods associated with each phase may be longer, shorter, and otherwise controllable; for example, the time periods can be selected to be compatible with time periods specified by medical-insurance telemedicine codes so that a physician billing under telemedicine codescan collect the maximum reimbursement allowed by a medical insurer. The type and amount of data collected may also be controllable. The added benefit of this passive monitoring process is that after the first phase of monitoring, the patient will be unaware of when data is being collected. Thus, the collected data will be protected from potential bias.

[0155] Along with the various different phases, the intelligent implant 2102 can operate in various modes to detect different types of movements. In this way, when a predetermined type of movement is detected, the intelligent implant 2102 can increase, decrease, or otherwise control the amount and type of kinematic data and other data that is collected.

[0156] In one example, the intelligent implant 2102 may use a pedometer to determine if the patient is walking. If the intelligent implant 2102 measures that a determined numberof steps crosses a threshold value within a predetermined time, then the intelligent implant 2102 may determine that the patient is walking. In response to the determination, the amount and type of data collected can be started, stopped, increased, decreased, or otherwise suitably controlled. The intelligent implant 2102 may further control the data collection based on certain conditions, such as when the patient stops walking, when a selected maximum amount of data is collected for that collection session, when the intelligent implant 2102 times out, or based on other conditions. After data is collected in a particular session, the intelligent implant 2102 may stop collecting data until the next day, the next time the patient is walking, after previously collected data is offloaded (e.g., by transmitting the collected data to the home base station 2104), or in accordance with one or more other conditions.

[0157] The amount and type of data collected by an intelligent implant 2102 may be different from patient to patient, and the amount and type of data collected may change for a single patient. For example, a medical practitioner studying data collected by the intelligent implant 2102 of a particular patient may adjust or otherwise control how the intelligent implant 2102 collects future data.

[0158] The amount and type of data collected by an intelligent implant 2102 may be different for different body parts, for different types of movement, for different patient demographics, or for other differences. Alternatively, or in addition, the amount and type of data collected may change overtime based on other factors, such as how the patient is healing or feeling, how long the monitoring process is projected to last, how much battery power remains and should be conserved, the type of movement being monitored, the body part being monitored, and the like. In some cases, the collected data is supplemented with personally descriptiveinformation provided by the patient such as subjective pain data, quality of life metric data, co-morbidities, perceptions, or expectations that the patient associates with the intelligent implant 2102, or the like.

[0159] In some embodiments, the intelligent implant 2102 is implanted into a patient to monitor movement or other aspects of a particular body part. Implantation of the intelligent implant 2102 into the patient may occur in an operating room. As used herein, an operating room includes any office, room, building, or facility where the intelligent implant 2102 is implanted into the patient. For example, the operating room may be a typical operating room in a hospital, an operating room in a surgical clinic or a doctor's office, or any other operating theater where the intelligent implant 2102 is implanted into the patient.

[0160] Once the intelligent implant 2102 is implanted into the patient and the patient returns home, the home base station 2104, the smart device 2105 (e.g., the patient's smart phone), the connected personal assistant 2107, or two or more of the home base station, and the smart device, and the connected personal assistant can communicate with the intelligent implant 2102. The intelligent implant 2102 can collect kinematic data at determined rates and times, variable rates and times, or otherwise controllable rates and times. Data collection can start when the intelligent implant 2102 is initialized in the operating room, when directed by a medical practitioner, or at some later point in time. At least some data collected by the intelligent implant 2102 may be transmitted to the home base station 2104 directly, to the smart device 2105 directly, to the connected personal assistant 2107 directly, 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, "one or both" means via an item alone, and via both items serially or in parallel. For example, data collected by the intelligent implant 2102 may be transmitted to the home base station 2104 via the smart device 2105 alone, via the connected personal assistant 2107 alone, serially via the smart device and the connected personal assistant, serially via the connected personal assistant and the smart device, and directly, and possibly contemporaneously, via both the smart device and the connected personal assistant.

[0161] Similarly, data collected by the intelligent implant 2102 may be transmitted to the smart device 2105 via the home base station 2104 alone, via the connected personal assistant 2107 alone, serially via the home base station and the connected personal assistant, seriallyvia the connected personal assistant and the home base station, and directly, and possibly contemporaneously, via both the home base station and the connected personal assistant. Further in example, data collected by the intelligent implant 2102 may be transmitted to the connected personal assistant 2107 via the smart device 2105 alone, via the home base station 2104 alone, serially via the smart device and the home base station, serially via the home base station and the smart device, and directly, and possibly contemporaneously, via both the smart device and the home base station.

[0162] In various embodiments, one or more of the home base station 2104, the smart device 2105, and the connected personal assistant 2107 pings the intelligent implant 2102 at periodic, predetermined, or other times to determine if the intelligent implant 2102 is within communication range of one or more of the home base station, the smart device, and the connected personal assistant. Based on a response from the intelligent implant 2102, one or more of the home base station 2104, the smart device 2105, and the connected personal assistant 2107 determines that the intelligent implant 2102 is within communication range, and the intelligent implant 2102 can be requested, commanded, or otherwise directed to transmit the data it has collected to one or more of the home base station 2104, the smart device 2105, and the connected personal assistant 2107.

[0163] Along with transmitting collected data to the cloud 2108, one or more of the home base station 2104, the smart device 2105, and the connected personal assistant 2107 may also obtain data, commands, or other information from the cloud 2108 directly or via the home network 2106. One or more of the home base station 2104, the smart device 2105, and the connected personal assistant 2107 may provide some or all of the received data, commands, or other information to the intelligent implant 2102. Examples of such information include, but are not limited to, updated configuration information, diagnostic requests to determine if the intelligent implant 2102 is functioning properly, data collection requests, and other information.

[0164] The cloud 2108 may include one or more server computers or databases to aggregate data collected from the intelligent implant 2102, and in some cases personally descriptive information collected from a patient, with data collected from other intelligent implants (not illustrated), and in some cases personally descriptive information collected from other patients. In this way, the cloud 2108 can create a variety of different metrics regarding collected data from each of a plurality of intelligent implants that are implanted into separatepatients. This information can be helpful in determining if the intelligent implants are functioning properly. The collected information may also be helpful for other purposes, such as determining which specific devices may not be functioning properly, determining if a procedure or condition associated with the intelligent implant is helping the patient (e.g., if the knee replacement is operating properly and reducing the patient's pain), and determining other medical information.

[0165] At various times throughout the monitoring process, the patient may be requested to visit a medical practitioner for follow up appointments. This medical practitioner may be the surgeon who implanted the intelligent implant 2102 in the patient or a different medical practitioner that supervises the monitoring process, physical therapy, and recovery of the patient. For a variety of different reasons, the medical practitioner may want to collect realtime data from the intelligent implant 2102 in a controlled environment. In some cases, the request to visit the medical practitioner may be delivered through a respective optional bidirectional user interface of each of one or more of the home base station 2104, the smart device 2105, and the connected personal assistant 2107.

[0166] A medical practitioner utilizes the doctor office base station, which communicates with the intelligent implant 2102, to pass additional data between the doctor office base station and the intelligent implant 2102. Alternatively, or in addition, the medical practitioner utilizes the doctor office base station to pass commands to the intelligent implant 2102. In some embodiments, the doctor office base station instructs the intelligent implant 2102 to enter a high-resolution mode to temporarily increase the rate or type of data that is collected for a short time. The high-resolution mode directs the intelligent implant 2102 to collect different (e.g., large) amounts of data during an activity where the medical practitioner is also monitoring the patient.

[0167] The devices, methods, systems etc. of the present disclosure have been described broadly and generically herein. Each of the narrower species and subgeneric groupings falling within the generic disclosure also form part of the present disclosure. This includes the generic description of the devices, methods, systems etc. of the present disclosure with a proviso or negative limitation removing any subject matter from the genus, regardless of whether or not the excised material is specifically recited herein.

[0168] It is also to be understood that as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural reference unless the context clearly dictatesotherwise, the term "X and / or Y" means "X" or "Y" or both "X" and "Y", and the letter "s" following a noun designates both the plural and singular forms of that noun. In addition, where features or aspects of the present disclosure are described in terms of Markush groups, it is intended, and those skilled in the art will recognize, that the present disclosure embraces and is also thereby described in terms of any individual member and any subgroup of members of the Markush group, and Applicants reserve the right to revise the application or claims to refer specifically to any individual member or any subgroup of members of the Markush group.

[0169] It is to be understood that the terminology used herein is for the purpose of describing specific embodiments only and is not intended to be limiting. It is further to be understood that unless specifically defined herein, the terminology used herein is to be given its traditional meaning as known in the relevant art.

[0170] Reference throughout this specification to "one embodiment" or "an embodiment" and variations thereof means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0171] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents, i.e., one or more, unless the content and context clearly dictates otherwise. For example, the term "a sensor" refers to one or more sensors, and the term "a medical device comprising a sensor" is a reference to a medical device that includes at least one sensor. A plurality of sensors refers to more than one sensor. It should also be noted that the conjunctive terms, "and" and "or" are generally employed in the broadest sense to include "and / or" unless the content and context clearly dictates inclusivity or exclusivity as the case may be. Thus, the use of the alternative (e.g., "or") should be understood to mean either one, both, or any combination thereof of the alternatives. In addition, the composition of "and" and "or" when recited herein as "and / or" is intended to encompass an embodiment that includes all of the associated items or ideas and one or more other alternative embodiments that include fewer than all of the associated items or ideas.

[0172] Unless the context requires otherwise, throughout the specification and claims thatfollow, the word "comprise" and synonyms and variants thereof such as "have" and "include," as well as variations thereof such as "comprises" and "comprising" are to be construed in an open, inclusive sense, e.g., "including, but not limited to." The term "consisting essentially of" limits the scope of a claim to the specified materials or steps, or to those that do not materially affect the basic and novel characteristics of the claimed invention.

[0173] Any headings used within this document are only being utilized to expedite its review by the reader, and should not be construed as limiting the disclosure, invention or claims in any manner. Thus, the headings and Abstract of the Disclosure provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.

[0174] Where a range of values is provided herein, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the disclosure, invention, or claims. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges, 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.

[0175] In general, in the following claims, the terms used should not be construed to limit the claims to the specific embodiments disclosed in the specification and the claims, but should be construed to include all possible embodiments along with the full scope of equivalents to which such claims are entitled. Accordingly, the claims are not limited by the disclosure.

[0176] Furthermore, the written description portion of this patent includes all claims. Furthermore, all claims, including all original claims as well as all claims from any and all priority documents, are hereby incorporated by reference in their entirety into the written description portion of the specification, and Applicants reserve the right to physically incorporate into the written description or any other portion of the application, any and all such claims. Thus, for example, under no circumstances may the patent be interpreted as allegedly not providing a written description for a claim on the assertion that the precise wording of the claim is not set forth in haec verba in written description portion of the patent. The claims will be interpreted according to law. However, and notwithstanding the alleged or perceived ease or difficulty of interpreting any claim or portion thereof, under no circumstances may any adjustment or amendment of a claim or any portion thereof duringprosecution of the application or applications leading to this patent be interpreted as having forfeited any right to any and all equivalents thereof that do not form a part of the prior art.

[0177] Other nonlimiting embodiments are within the following claims. The patent may not be interpreted to be limited to the specific examples or nonlimiting embodiments or methods specifically and / or expressly disclosed herein. Under no circumstances may the patent be interpreted to be limited by any statement made by any Examiner or any other official or employee of the Patent and Trademark Office unless such statement is specifically and without qualification or reservation expressly adopted in a responsive writing by Applicants.

[0178] As mentioned above, in the following claims, the terms used should not be construed to limit the claims to the specific embodiments disclosed in the specification and the claims, but should be construed to include all possible embodiments along with the full scope of equivalents to which such claims are entitled. For example, described embodiments with one or more omitted components or steps can be additional embodiments contemplated and covered by this application.Example Embodiments

[0179] The present disclosure provides the following as exemplary embodiments, which are numbered for convenience:1) A system comprising a cartridge and a complementarily-shaped securing insert comprising: an electronics assembly comprising at least one sensor, and a controller having a jointspecific module, the joint-specific module configured to collect kinematic data resulting from movement of a specific joint sensed by the at least one sensor; and a housing enclosing the electronics assembly; and a cartridge coupling feature configured to couple the cartridge to the securing insert, the cartridge and the securing insert having form factors that fit at least partially within a receptacle of a bone adjacent to a natural joint of a body.2) The system of embodiment 1 and 3-20, wherein the joint-specific module comprises a knee module configured to collect kinematic data resulting from movement of a knee sensed by the at least one sensor.3) The system of embodiments 1-2 and 4-20, wherein the receptacle is formed in the tibia.4) The system of embodiments 1-3 and 5-20 wherein the kinematic data is indicative of a laxity of the knee.5) The system of embodiments 1-4 and 6-20, wherein the kinematic data is indicative of a flexion and / or extension of the knee.6) The system of embodiments 1-5 and 7-20 wherein the at least one sensor comprises one or more accelerometers, one or more gyroscopes, or a combination of one or more accelerometers and one or more gyroscopes.7) The system of embodiments 1-5 and 8-20, further comprising an antenna assembly coupled to the electronics assembly and extending from an end of the housing, and optionally further comprising a memory to store the data generated by the sensor.8) The system of embodiment 7, wherein: the antenna assembly comprises an antenna that couples to the electronics assembly, and a cap that covers the antenna; and the cartridge further comprises an external sensor associated with the cap and that couples to the electronics assembly.9) The system of embodiments 1-8 and 10-20, wherein the securing insert has a surface feature that enables the securing insert to associate with the receptacle to secure the cartridge and securing insert in the receptacle.10) The system of embodiment 9, wherein the surface feature comprises threads.11) The system of embodiment 1-10 and 12-20, wherein the securing insert is a threaded screw.12) The system of embodiments 1-11 and 13-20, wherein the cartridge and the complementarily-shaped securing insert are each sterile.13) The system of embodiments 1-12 and 14-20, wherein the cartridge and / or the securing insert are configured to secure a tensioned element used in an ACL surgery within the receptacle.14) The system of embodiment 13, wherein the securing insert comprises an interference screw.15) The system of embodiments 13-14, wherein the receptacle is a through hole formed in the tibia and is configured to receive the tensioned element comprising an ACL graft.16) The system of embodiment 15, wherein the securing insert comprises a first channel for receiving the ACL graft and a second channel for receiving the cartridge.17) The system of embodiments 13-16, wherein the receptacle is formed in the tibia and is configured to receive the tensioned element comprising a rope or a suture.18) The system of embodiments 1-17 and 19-10, wherein the cartridge is configured to partially extend out of the receptacle after insertion into the receptacle.19) The system of embodiments 1-18, wherein the cartridge comprises a plate portion configured to extend out of the receptacle and along the bone after insertion into the receptacle.20) The system of embodiment 19, wherein the plate portion is configured to interface with a surface of the bone.21) A smart cartridge for implanting into a receptacle of a bone, comprising: an electronics assembly comprising at least one sensor, and a controller having a jointspecific module, the joint-specific module configured to collect kinematic data resulting from movement of a specific joint sensed by the at least one sensor; and a housing enclosing the electronics assembly; where the housing comprises a surface feature that enables the smart cartridge to associate with the receptacle to secure the smart cartridge at least partially within the receptacle.22) The smart cartridge of embodiments 21 and 23-37, wherein the surface feature comprises threads.23) The smart cartridge of embodiments 21-22 and 24-37, wherein the surface feature is a keyed flange configured to be located at the cortical bone interface when the smart cartridge is implanted into the receptacle.24) The smart cartridge of embodiments 21-23 and 25-37, wherein the joint-specific module comprises a knee module configured to collect kinematic data resulting from movement of a knee sensed by the at least one sensor.25) The smart cartridge of embodiments 21-24 and 26-37, wherein the receptacle is formed in the tibia.26) The smart cartridge of embodiments 21-25 and l- 1 , wherein the kinematic data is indicative of a laxity of the knee.) The smart cartridge of embodiments 21-26 and 28-37, wherein the kinematic data is indicative of a flexion and / or extension of the knee. ) The smart cartridge of embodiments 21-27 and 29-37, wherein the at least one sensor comprises one or more accelerometers, one or more gyroscopes, or a combination of one or more accelerometers and one or more gyroscopes. ) The smart cartridge of embodiments 21-28 and 30-37, further comprising an antenna assembly coupled to the electronics assembly and extending from an end of the housing, and optionally further comprising a memory to store data that is generated by the sensor. ) The smart cartridge of embodiment 29, wherein: the antenna assembly comprises an antenna that couples to the electronics assembly, and a cap that covers the antenna; and the cartridge further comprises an external sensor associated with the cap and that couples to the electronics assembly. ) The smart cartridge of embodiments 21-30 and 32-37, wherein the cartridge is sterile.) The smart cartridge of embodiments 21-31 and 33-37, wherein the cartridge is configured to secure a tensioned element used for an ACL surgery within the bone receptacle. ) The smart cartridge of embodiments 32 and 34, wherein the receptacle comprises a through hole formed in the tibia and configured to receive the tensioned element comprising an ACL graft. ) The smart cartridge of embodiments 32-33, wherein the receptacle is formed in the tibia and configured to receive the tensioned element comprising a rope or a suture.) The smart cartridge of embodiments 21-34 and 36-37, wherein the cartridge is configured to partially extend out of the receptacle of the bone when the smart cartridge is implanted into the receptacle. ) The smart cartridge of embodiments 21-35 and 37, wherein the cartridge comprises a plate portion configured to extend out of the receptacle and along the bone after implantation into the receptacle. ) The smart cartridge of embodiment 36, wherein the plate portion is configured to interface with a surface of the bone. ) An intelligent implant for implanting into a receptacle of a bone, comprising: a cartridge comprising:an electronics assembly comprising at least one sensor, and a controller having a jointspecific module, the joint-specific module configured to collect kinematic data resulting from movement of a specific joint sensed by the at least one sensor; and a housing enclosing the electronics assembly; wherein the intelligent implant has a surface feature that enables the implant to associate with the receptacle to secure the implant at least partially within the receptacle.39) The intelligent implant of embodiments 38 and 40-55, wherein the joint-specific module comprises a knee module configured to collect kinematic data resulting from movement of a knee sensed by the at least one sensor.40) The intelligent implant of embodiments 38-39 and 41-55, wherein the receptacle is formed in the tibia.41) The intelligent implant of embodiments 38-40 and 42-55, wherein the kinematic data is indicative of a laxity of the knee.42) The intelligent implant of embodiments 38-41 and 43-55, wherein the kinematic data is indicative of a flexion and / or extension of the knee.43) The intelligent implant of embodiments 38-42 and 44-55, further comprising a securing feature coupled to the housing of the cartridge.44) The intelligent implant of embodiment 43, wherein the securing insert comprises the surface feature.45) The intelligent implant of embodiments 43-44 and 46-47, wherein the surface feature comprises threads.46) The intelligent implant of embodiment 43-45 and 47, wherein the securing insert comprises an interference screw.47) The intelligent implant of embodiments 43-46, wherein the securing insert comprises a first channel for receiving the tensioned element and a second channel for receiving the cartridge.48) The intelligent implant of embodiments 43-48, wherein the housing of the cartridge comprises the surface feature.49) The intelligent implant of embodiment 48, wherein the surface feature comprises threads.50) The intelligent implant of embodiment 48, wherein the surface feature is a keyed flange configured to be located at the cortical bone interface when the cartridge is implanted into the receptacle.51) The intelligent implant of embodiments 38-50 and 52-55, wherein the implant is configured to secure a tensioned element used for an ACL surgery.52) The intelligent implant of embodiments 51 and 53-55, wherein the receptacle is a through hole formed in the tibia and configured to receive the tensioned element comprising an ACL graft.53) The intelligent implant of Embodiments 51-52 and 54-55, wherein the receptacle is formed in the tibia and is configured to receive the tensioned element comprising a rope or a suture.54) The intelligent implant of embodiments 38-53 and 55, wherein the implant comprises a plate portion configured to extend out of the receptacle and along the bone after implantation.55) The intelligent implant of embodiment 54, wherein the plate portion is configured to interface with a surface of the bone.56) An intelligent implant for implanting into a receptacle of a bone during an ACL surgery, comprising: a cartridge comprising: an electronics assembly comprising at least one sensor, and a controller having a kneespecific module, the knee-specific module configured to collect kinematic data resulting from movement of a knee sensed by the at least one sensor; and a housing enclosing the electronics assembly; wherein the intelligent implant is configured to secure a tensioned element used for the ACL surgery within the receptacle.57) The intelligent implant of embodiments 56 and 58-71, wherein the receptacle is formed in the tibia.58) The intelligent implant of embodiments 56-57 and 59-71, wherein the kinematic data is indicative of a laxity of the knee.59) The intelligent implant of embodiments 56-58 and 60-71, wherein the kinematic data is indicative of a flexion and / or extension of the knee.) The intelligent implant of embodiments 56-60 and 61-71, further comprising a securing insert coupled to the housing of the cartridge. ) The intelligent implant of embodiments 60-64, wherein the securing insert comprises a surface feature that enables the implant to associate with the receptacle to secure the implant in the receptacle. ) The intelligent implant of embodiments 61 and 63-64, wherein the surface feature comprises threads. ) The intelligent implant of embodiments 60-62 and 64, wherein the securing insert comprises an interference screw. ) The intelligent implant of embodiments 60-63, wherein the securing insert comprises a first channel for receiving the tensioned element and a second channel for receiving the cartridge. ) The intelligent implant of embodiments 56-64 and 66-71, wherein the housing of the cartridge comprises a surface feature that enables the implant to associate with the receptacle to secure the implant in the receptacle. ) The intelligent implant of embodiment 65, wherein the surface feature comprises threads. ) The intelligent implant of embodiment 65, wherein the surface feature is a keyed flange configured to be located at the cortical bone interface when the cartridge is implanted into the receptacle. ) The intelligent implant of embodiments 56-67 and 69-71, wherein the receptacle is a through hole formed in the tibia and configured to receive the tensioned element comprising an ACL graft. ) The intelligent implant of embodiments 56-68 and 70-71, wherein the receptacle is formed in the tibia and is configured to receive the tensioned element comprising a rope or a suture. ) The intelligent implant of embodiments 56-69 and 71, wherein the implant comprises a plate portion configured to extend out of the receptacle and along the bone after implantation. ) The intelligent implant of embodiment 70, wherein the plate portion is configured to interface with a surface of the bone. ) A smart cartridge for subcutaneous implantation near a bone, comprising:an electronics assembly comprising at least one sensor, and a controller having a jointspecific module, the joint-specific module configured to collect kinematic data resulting from movement of a specific joint sensed by the at least one sensor; and a housing enclosing the electronics assembly; wherein the smart cartridge is configured to be subcutaneously implanted adjacent to a natural joint of a body.73) The smart cartridge of embodiments 72 and 74-84, wherein the joint-specific module comprises a knee module configured to collect kinematic data resulting from movement of a knee sensed by the at least one sensor.74) The smart cartridge of embodiments 72-73 and 75-84, wherein the kinematic data is indicative of a laxity of the knee.75) The smart cartridge of embodiments 72-74 and 76-84, wherein the kinematic data is indicative of a flexion and / or extension of the knee.76) The smart cartridge of embodiments 72-75 and 77-84, wherein the at least one sensor comprises one or more accelerometers, one or more gyroscopes, or a combination of one or more accelerometers and one or more gyroscopes.77) The smart cartridge of embodiments 72-76 and 78-84, wherein the cartridge is implanted distal to a proximal tibiofibular joint of a leg.78) The smart cartridge of embodiments 72-77 and 79-84, wherein the cartridge is implanted at least partially in an anterior compartment of a leg.79) The smart cartridge of embodiments 72-78 and 80-84, wherein the cartridge is implanted at least partially in a posterior compartment of a leg.80) The smart cartridge of embodiments 72-79 and 81-84, further comprising an antenna assembly coupled to the electronics assembly and extending from an end of the housing, and optionally further comprising a memory that store data generated by the sensor.81) The smart cartridge of embodiment 80, wherein: the antenna assembly comprises an antenna that couples to the electronics assembly, and a cap that covers the antenna; and the cartridge further comprises an external sensor associated with the cap and that couples to the electronics assembly.82) The smart cartridge of embodiments 72-81 and 83-84, wherein the cartridge is sterile.83) The smart cartridge of embodiments 72-82 and 84, wherein the housing comprises a securing mechanism to maintain a position of the cartridge when subcutaneously implanted.84) The smart cartridge of embodiments 72-83, wherein the cartridge is configured to be at least partially covered by a liner when implanted.85) A method of monitoring a joint surgery in a patient, comprising: implanting a smart cartridge into a receptacle of a bone, where the bone is associated with a joint that has, or will have, a joint surgery, wherein the smart cartridge comprises: an electronics assembly comprising at least one sensor, and a controller having a jointspecific module, the joint-specific module configured to collect kinematic data resulting from movement of a specific joint sensed by the at least one sensor; and a housing enclosing the electronics assembly.86) The method of embodiments 85 and 87-91, wherein the housing comprises a surface feature that enables the smart cartridge to associate with the receptacle to secure the smart cartridge in the receptacle.87) The method of embodiment 86, wherein the surface feature comprises threads.88) The method of embodiments 86-87, wherein surface feature is a keyed flange configured to be positioned at the cortical bone interface when the smart cartridge is inserted in the receptacle.89) The method of embodiments 85-88 and 90-91, wherein the cartridge has a form factor that is configured to fit at least partially within the receptacle.90) The method of embodiments 85-89 and 91, wherein implanting the smart cartridge comprises inserting a securing feature into the receptacle such that the smart cartridge couples to the securing feature to secure the smart cartridge in the receptacle.91) The method of embodiment 89, wherein the securing feature is a threaded screw.92) A method of monitoring a joint surgery in a patient, comprising: implanting an intelligent implant into a receptacle of a bone, where the bone is associated with a joint that has, or will have, a joint surgery, wherein the intelligent implant comprises: a cartridge comprising:an electronics assembly comprising at least one sensor, and a controller having a jointspecific module, the joint-specific module configured to collect kinematic data resulting from movement of a specific joint sensed by the at least one sensor; and a housing enclosing the electronics assembly.93) The method of embodiments 92 and 94-102, wherein the implant has a form factor that is configured to fit at least partially within the receptacle.94) The method of embodiments 92-93 and 95-102, wherein the intelligent implant comprises a securing feature configured to couple to the cartridge and secure the implant at least partially within the receptacle.95) The method of embodiment 94, wherein the securing feature is a threaded screw.96) The method of embodiment 94, wherein implanting the intelligent implant comprises inserting the securing feature into the receptacle before coupling the cartridge to the securing feature.97) The method of embodiment 94, wherein the cartridge is coupled to the securing feature before implanting the implant into the receptacle.98) The method of embodiments 92-97 and 99-102, wherein the housing comprises a surface feature that enables the cartridge to associate with the receptacle to secure the implant in the receptacle.99) The method of embodiments 92-98 and 100-102, wherein implanting the implant secures a tensioned element used for an ACL surgery within the receptacle.100) The method of embodiment 99, wherein the receptacle is a through hole formed in the tibia and configured to receive the tensioned element comprising an ACL graft.101) The method of embodiment 99, wherein the receptacle is formed in the tibia and is configured to receive the tensioned element comprising a rope or a suture.102) The method of embodiment 92-101, wherein the implant extends partially out of the receptacle when implanted into the receptacle.103) A method of monitoring an ACL surgery in a patient, comprising: implanting a smart cartridge in or adjacent to a bone, where the bone is associated with a joint that has, or will have, an ACL surgery, wherein the smart cartridge comprises:an electronics assembly comprising at least one sensor, and a controller having a kneespecific module, the knee-specific module configured to collect kinematic data resulting from movement of a knee sensed by the at least one sensor; and a housing enclosing the electronics assembly; wherein the collected kinematic data is indicative of a laxity, a flexion, and / or an extension of the knee.104) The method of embodiments 103 and 105-114, wherein the smart cartridge is implanted into a receptacle of the bone.105) The method of embodiments 103-104 and 106-114, wherein implanting the smart cartridge comprises inserting a securing feature into the receptacle such that the smart cartridge couples to the securing feature to secure the smart cartridge in the receptacle.106) The method of embodiments 103-105 and 107-114, wherein the housing of the smart cartridge comprises a surface feature that enables the smart cartridge to associate with the receptacle to secure the smart cartridge in the receptacle.107) The method of embodiments 103-106 and 108-114, wherein implanting the smart cartridge secures a tensioned element used for the ACL surgery within the receptacle.108) The method of embodiment 107, wherein the receptacle is a through hole formed in the tibia and is configured to receive the tensioned element comprising an ACL graft.109) The method of embodiment 107, wherein the receptacle is formed in the tibia and is configured to receive the tensioned element comprising a rope or a suture.110) The method of embodiments 103-109 and 111-114, wherein the smart cartridge extends partially out of the receptacle when implanted into the receptacle.111) The method of embodiments 103-110 and 112-114, wherein the smart cartridge is subcutaneously implanted adjacent to the bone.112) The method of embodiments 103-111 and 113-114, wherein the smart cartridge is implanted distal to a proximal tibiofibular joint of a leg.113) The method of embodiments 103-112 and 114, wherein the smart cartridge is at least partially covered by a securing liner during subcutaneous implantation.114) The method of embodiment 103-113, wherein the bone is a tibia of the patient.115) A smart cartridge for subcutaneous implantation into a host, comprising: an electronics assembly comprising a sensor, and a controller having a data-collection module, the data-collection module configured to collect kinematic data sensed by the sensor, where the data characterizes a movement of the host; and a housing enclosing the electronics assembly; wherein the smart cartridge is configured to be subcutaneously implanted at a location within the host.116) The smart cartridge of embodiments 115 and 117-153, wherein the host is a human.117) The smart cartridge of embodiments 115-116 and 118-153, wherein the location is adjacent to a bone.118) The smart cartridge of embodiments 115-117 and 124-153, wherein the location is adjacent to a bone, where the bone is a spinal bone, optionally selected from a cervical, thoracic, lumbar, sacrum and coccyx bone.119) The smart cartridge of embodiments 115-117 and 124-153, wherein the location is adjacent to a natural joint of a body of the host.120) The smart cartridge of embodiments 115-117 and 124-153, wherein the location is adjacent to a natural joint of a body of the host, and the joint is selected from an ankle, a knee, a hip, a wrist, an elbow, and a shoulder.121) The smart cartridge of embodiments 115-117 and 124-153, wherein the location is distal to a proximal tibiofibular joint of a leg.122) The smart cartridge of embodiments 115-117 and 124-153, wherein the location is at least partially in an anterior compartment of a leg.123) The smart cartridge of embodiments 115-117 and 124-153, wherein the location is at least partially in a posterior compartment of a leg.124) The smart cartridge of embodiments 115-123 and 125-153, wherein the movement is of a specific joint of the host.125) The smart cartridge of embodiments 115-124 and 126-153, wherein the data- collection module is a joint-specific module.) The smart cartridge of embodiments 115 -125 and 127-153, for subcutaneous implantation near a bone, comprising an electronics assembly comprising a sensor, and a controller having a joint-specific module, the joint-specific module configured to collect kinematic data resulting from movement of a specific joint sensed by the at least one sensor; and a housing enclosing the electronics assembly; wherein the smart cartridge is configured to be subcutaneously implanted adjacent to a natural joint of a body of the host. ) The smart cartridge of embodiments 115-117, wherein the data-collection module is a joint-specific module comprising a knee module configured to collect kinematic data resulting from movement of a knee sensed by the at least one sensor.) The smart cartridge of embodiments 127 wherein the kinematic data is indicative of a laxity of the knee. ) The smart cartridge of embodiment 127, wherein the kinematic data is indicative of a flexion and / or extension of the knee. ) The smart cartridge of embodiments 115-129 and 131-153, wherein sensor comprises one or more accelerometers, one or more gyroscopes, or a combination of one or more accelerometers and one or more gyroscopes. ) The smart cartridge of embodiments 115-130 and 132-153, wherein the sensor comprises an external sensor, where the external sensor physically contacts the body of the host. ) The smart cartridge of embodiments 115-131 and 133-153, wherein the housing comprises no sharp features that could damage tissue in contact with the implanted smart cartridge. ) The smart cartridge of embodiments 115-132 and 134-153, wherein the housing comprises exclusively biocompatible materials that will not harm tissue in contact with the implanted smart cartridge. ) The smart cartridge of embodiments 115-133 and 135-153, wherein the housing comprises a biocompatible material selected from metal, silicone and parylene. ) The smart cartridge of embodiments 115-134 and 136-153, wherein the housing comprises a metal which covers the sensor and the controller, and a plastic or ceramic which covers an antenna.) The smart cartridge of embodiments 115-135 and 137-153 wherein the housing does not include a feature or mechanism for securing the smart cartridge to a bone of the body. ) The smart cartridge of embodiments 115-136 and 138-153 wherein the housing is not configured to be secured to or otherwise associated with a medical implant or prosthesis located within the body. ) The smart cartridge of embodiments 115-137 and 139-153 wherein the housing is not configured to be secured to or otherwise associated with a bone of the host. ) The smart cartridge of embodiments 115-138 and 140-153, wherein the housing comprises a securing mechanism to maintain a position of the cartridge when subcutaneously implanted. ) The smart cartridge of embodiments 115-139 and 141-153, wherein the housing comprises a securing mechanism to maintain a position of the cartridge when subcutaneously implanted within muscle of a host. ) The smart cartridge of embodiments 115-140 and 142-153, wherein the housing comprises a securing mechanism to maintain a position of the cartridge when it is subcutaneously implanted in the host at a location distant from a bone or implanted medical device or prosthesis of the host. ) The smart cartridge of embodiments 115-141 and 143-153 wherein the housing comprises a securing mechanism which functions only to maintain a position of the cartridge in the host when it is subcutaneously implanted in the host. ) The smart cartridge of embodiments 115,-142 and 144-153 wherein the cartridge is configured to be at least partially covered by a liner when implanted., and where optionally the smart cartridge is in contact with the liner. ) The smart cartridge of embodiments 115-143 and 145-153, having a length of between 20 mm and 50 mm, a maximum width of between 6 mm and 15 mm, and a maximum depth of between 6 mm and 15 mm. ) The smart cartridge of embodiments 115-144 and 146-153, comprising a power component contained within the housing, where the power component provides power to the sensor.) The smart cartridge of embodiment 145, wherein the power component is a battery. ) The smart cartridge of embodiments 115-146 and 148-153, further comprising an antenna assembly coupled to the electronics assembly, where the antenna assembly comprises an antenna, and optionally further comprising a memory to store data generated by the sensor. ) The smart cartridge of embodiment 147, wherein the antenna is selected from a wire antenna, a conformal antenna, and a planar antenna. ) The smart cartridge of embodiments 147-148 where the antenna extends from an end of the housing. ) The smart cartridge of embodiments 147-149 and 153, comprising a cap that covers the antenna, where the cap protects the antenna and allows radio frequency (RF) signals to propagate through the cap with acceptable levels of attenuation and other signal degradation. ) The smart cartridge of embodiment 150, wherein the cap comprises polyether ether-ketone (PEEK). ) The smart cartridge of embodiments 115-151 and 153, wherein the cartridge further comprises an external sensor associated with a cap that covers an antenna of the smart cartridge, where the antenna couples to the electronics assembly. ) The smart cartridge of embodiments 115-152 wherein the cartridge is sterile.) A smart cartridge for collecting kinematic data from a subject, comprising: an electronics assembly comprising at least one sensor, and a controller configured to collect kinematic data resulting from movement of a knee sensed by the at least one sensor; and a housing enclosing the electronics assembly; wherein the smart cartridge is not connected to an artificial knee, hip, or shoulder prosthesis. ) A smart cartridge for collecting kinematic data from a subject, comprising: an electronics assembly comprising at least one sensor, and a controller configured to collect kinematic data resulting from movement of a hip sensed by the at least one sensor; and a housing enclosing the electronics assembly; wherein the smart cartridge is not connected to an artificial knee, hip, or shoulder prosthesis. ) A smart cartridge for collecting kinematic data from a subject, comprising: an electronics assembly comprising at least one sensor, and a controller configured tocollect kinematic data resulting from movement of a shoulder sensed by the at least one sensor; and a housing enclosing the electronics assembly; wherein the smart cartridge is not connected to an artificial knee, hip, or shoulder prosthesis.157) A smart cartridge for collecting kinematic data from a subject, comprising: an electronics assembly comprising at least one sensor, and a controller configured to collect kinematic data resulting from movement of a vertebrae sensed by the at least one sensor; and a housing enclosing the electronics assembly; wherein the smart cartridge is not connected to an artificial knee, hip, or shoulder prosthesis.158) A method of monitoring a movement of a host, the method comprising: selecting a host having a smart cartridge implanted at a location in the host, wherein the smart cartridge comprises an electronics assembly comprising a sensor and a controller having a data-collection module, where the data-collection module configured to collect kinematic data generated by the sensor, where the data characterizes a movement of the host, the smart cartridge further comprising a housing enclosing the electronics assembly; sensing the movement of the host with the sensor to generate kinematic data, where the kinematic data provides a characterization of the movement of the host; collecting the kinematic data in a memory enclosed by the housing to provide collected kinematic data; providing transmitted data by way of transmitting the collected kinematic data to a location outside of the housing and / or analyzing the collected kinematic data within the housing to provide movement information and transmitting the movement information to a location outside of the housing; analyzing the transmitted data to provide a characterization of the movement of the host.159) The method of embodiments 158 and 160-182 wherein the host is a human.160) The method of embodiments 158-159 and 161-182 wherein the host has a partial or total artificial joint.161) The method of embodiments 158 -159 and 161-182 wherein the host has anACL injury and / or has had ACL surgery.) The method of embodiments 158-161 and 163-182 wherein the host has an abnormal gait. ) The method of embodiments 162 wherein the host has a neurological disorder selected from Parkinson's disease, Alzheimer's disease, Huntington's Disease, cerebellar ataxia, multiple sclerosis, peripheral neuropathy, myelopathy, or a neurological disorder brought on by a stroke or a spinal cord injury. ) The method of embodiments 158-163 and 178-182 wherein the host has an implanted smart cartridge secured directly to a bone of the host. ) The method of embodiments 158-163 and 178-182 wherein the host has an implanted smart cartridge secured directly to a threaded insert, where the threaded insert is secured directly to the bone. ) The method of embodiments 158-163 and 178-182, wherein the smart cartridge is located in a receptacle of the bone. ) The method of embodiments 158-163 and 178-182, wherein the smart cartridge is located in a receptacle that has been formed in the exterior of the bone.) The method of embodiments 158-163 and 178-182, wherein the smart cartridge is located in a receptacle of a bone and extends partially out of the receptacle when implanted into the receptacle. ) The method of embodiments 158-163 and 178-182, wherein the smart cartridge comprises a securing feature, wherein the smart cartridge and securing feature are inserted into a receptacle of a bone such that the smart cartridge couples to the securing feature to secure the smart cartridge in the receptacle. ) The method of embodiments 158-163 and 178-182, wherein the housing of the smart cartridge comprises a surface feature that enables the smart cartridge to associate with a receptacle in a bone to secure the smart cartridge in the receptacle.) The method of embodiments 158-163 and 178-182, wherein the smart cartridge is located in a receptacle of a bone and wherein the implanted smart cartridge secures a tensioned element used for the ACL surgery within the receptacle. ) The method of embodiments 158-163 and 178-182, wherein the smart cartridge is located in a receptacle of a bone and wherein the implanted smart cartridge secures a tensioned element used for the ACL surgery within thereceptacle; and wherein the receptacle is a through hole formed in the tibia and is configured to receive the tensioned element comprising an ACL graft. ) The method of embodiments 158-163 and 178-182, wherein the smart cartridge is located in a receptacle of the bone and wherein the implanted smart cartridge secures a tensioned element used for the ACL surgery within the receptacle; and wherein the receptacle is formed in the tibia and is configured to receive the tensioned element comprising a rope or a suture. ) The method of embodiments 158-163 and 178-182, wherein the smart cartridge is located subcutaneously adjacent to a bone. ) The method of embodiments 158-163 and 178-182, wherein the smart cartridge is located subcutaneously adjacent to a bone, where the bone is associated with a joint that has had or will have, an ACL surgery. ) The method of embodiments 158-163 and 178-182, wherein the smart cartridge is located subcutaneously adjacent to a bone; and wherein the smart cartridge is implanted distal to a proximal tibiofibular joint of a leg. ) The method of embodiments 158-163 and 178-182, wherein the smart cartridge is located subcutaneously adjacent to a bone; and wherein the smart cartridge is at least partially covered by a securing liner. ) The method of embodiments 158-177 wherein the location is a leg of the host. ) The method of embodiments 158-173, wherein the location is in a receptacle of a tibia of the host. ) The method of embodiments 158-163 and 174-178 wherein the location is adjacent to a joint of the host. ) The method of embodiments 158-163 and 174-178, wherein the location is adjacent to a tibia of the host. ) The method of embodiments 158-181, wherein the kinematic data is indicative of a laxity, a flexion, and / or an extension of a knee of the host.

Claims

CLAIMSWHAT IS CLAIMED IS:

1. A system comprising a cartridge and a complementarily-shaped securing insert comprising: an electronics assembly comprising at least one sensor, and a controller having a joint-specific module, the joint-specific module configured to collect kinematic data resulting from movement of a specific joint sensed by the at least one sensor; and a housing enclosing the electronics assembly; and a cartridge coupling feature configured to couple the cartridge to the securing insert, the cartridge and the securing insert having form factors that fit at least partially within a receptacle of a bone adjacent to a natural joint of a body.

2. The system of Claim 1, wherein the joint-specific module comprises a knee module configured to collect kinematic data resulting from movement of a knee sensed by the at least one sensor.

3. The system of Claim 2, wherein the receptacle is formed in the tibia.

4. The system of Claim 2, wherein the kinematic data is indicative of a laxity of the knee.

5. The system of Claim 2, wherein the kinematic data is indicative of a flexion and / or extension of the knee.

6. The system of Claim 1, wherein the at least one sensor comprises one or more accelerometers, one or more gyroscopes, or a combination of one or more accelerometers and one or more gyroscopes.

7. The system of Claim 1, further comprising an antenna assembly coupled to the electronics assembly and extending from an end of the housing.

8. The system of Claim 7, wherein: the antenna assembly comprises an antenna that couples to the electronics assembly, and a cap that covers the antenna; and the cartridge further comprises an external sensor associated with the cap and that couples to the electronics assembly.

9. The system of Claim 1, wherein the securing insert has a surface feature that enables the securing insert to associate with the receptacle to secure the cartridge and securing insert in the receptacle.

10. The system of Claim 9, wherein the surface feature comprises threads.

11. The system of Claim 1, wherein the securing insert is a threaded screw.

12. The system of Claim 1, wherein the cartridge and the complementarily-shaped securing insert are each sterile.

13. The system of Claim 1, wherein the cartridge and / or securing insert are configured to secure a tensioned element used in an ACL surgery within the receptacle.

14. The system of Claim 13, wherein the securing insert comprises an interference screw.

15. The system of Claim 13, wherein the receptacle is a through hole formed in the tibia and is configured to receive the tensioned element comprising an ACL graft.

16. The system of Claim 15, wherein the securing insert comprises a first channel for receiving the ACL graft and a second channel for receiving the cartridge.

17. The system of Claim 13, wherein the receptacle is formed in the tibia and is configured to receive the tensioned element comprising a rope or a suture.

18. The system of Claim 1, wherein the cartridge is configured to partially extend out of the receptacle after insertion into the receptacle.

19. The system of Claim 1, wherein the cartridge comprises a plate portion configured to extend out of the receptacle and along the bone after insertion into the receptacle.

20. The system of Claim 19, wherein the plate portion is configured to interface with a surface of the bone.

21. A smart cartridge for implanting into a receptacle of a bone, comprising: an electronics assembly comprising at least one sensor, and a controller having a joint-specific module, the joint-specific module configured to collect kinematic data resulting from movement of a specific joint sensed by the at least one sensor; and a housing enclosing the electronics assembly;where the housing comprises a surface feature that enables the smart cartridge to associate with the receptacle to secure the smart cartridge at least partially within the receptacle.

22. The smart cartridge of Claim 21, wherein the surface feature comprises threads.

23. The smart cartridge of Claim 21, wherein the surface feature is a keyed flange configured to be located at the cortical bone interface when the smart cartridge is implanted into the receptacle.

24. The smart cartridge of Claim 21, wherein the joint-specific module comprises a knee module configured to collect kinematic data resulting from movement of a knee sensed by the at least one sensor.

25. The smart cartridge of Claim 24, wherein the receptacle is formed in the tibia.

26. The smart cartridge of Claim 24, wherein the kinematic data is indicative of a laxity of the knee.

27. The smart cartridge of Claim 24, wherein the kinematic data is indicative of a flexion and / or extension of the knee.

28. The smart cartridge of Claim 21, wherein the at least one sensor comprises one or more accelerometers, one or more gyroscopes, or a combination of one or more accelerometers and one or more gyroscopes.

29. The smart cartridge of Claim 21, further comprising an antenna assembly coupled to the electronics assembly and extending from an end of the housing.

30. The smart cartridge of Claim 29, wherein: the antenna assembly comprises an antenna that couples to the electronics assembly, and a cap that covers the antenna; and the cartridge further comprises an external sensor associated with the cap and that couples to the electronics assembly.

31. The smart cartridge of Claim 21, wherein the cartridge is sterile.

32. The smart cartridge of Claim 21, wherein the cartridge is configured to secure a tensioned element used for an ACL surgery within the bone receptacle.

33. The smart cartridge of Claim 32, wherein the receptacle comprises a through hole formed in the tibia and configured to receive the tensioned element comprising an ACL graft.

34. The smart cartridge of Claim 32, wherein the receptacle is formed in the tibia and configured to receive the tensioned element comprising a rope or a suture.

35. The smart cartridge of Claim 21, wherein the cartridge is configured to partially extend out of the receptacle of the bone when the smart cartridge is implanted into the receptacle.

36. The smart cartridge of Claim 21, wherein the cartridge comprises a plate portion configured to extend out of the receptacle and along the bone after implantation into the receptacle.

37. The smart cartridge of Claim 36, wherein the plate portion is configured to interface with a surface of the bone.

38. An intelligent implant for implanting into a receptacle of a bone, comprising: a cartridge comprising: an electronics assembly comprising at least one sensor, and a controller having a joint-specific module, the joint-specific module configured to collect kinematic data resulting from movement of a specific joint sensed by the at least one sensor; and a housing enclosing the electronics assembly; wherein the intelligent implant has a surface feature that enables the implant to associate with the receptacle to secure the implant at least partially within the receptacle.

39. The intelligent implant of Claim 38, wherein the joint-specific module comprises a knee module configured to collect kinematic data resulting from movement of a knee sensed by the at least one sensor.

40. The intelligent implant of Claim 39, wherein the receptacle is formed in the tibia.

41. The intelligent implant of Claim 39, wherein the kinematic data is indicative of a laxity of the knee.

42. The intelligent implant of Claim 39, wherein the kinematic data is indicative of a flexion and / or extension of the knee.

43. The intelligent implant of Claim 38, further comprising a securing feature coupled to the housing of the cartridge.

44. The intelligent implant of Claim 43, wherein the securing insert comprises the surface feature.

45. The intelligent implant of Claim 44, wherein the surface feature comprises threads.

46. The intelligent implant of Claim 43, wherein the securing insert comprises an interference screw.

47. The intelligent implant of Claim 43, wherein the securing insert comprises a first channel for receiving the tensioned element and a second channel for receiving the cartridge.

48. The intelligent implant of Claim 38, wherein the housing of the cartridge comprises the surface feature.

49. The intelligent implant of Claim 48, wherein the surface feature comprises threads.

50. The intelligent implant of Claim 48, wherein the surface feature is a keyed flange configured to be located at the cortical bone interface when the cartridge is implanted into the receptacle.

51. The intelligent implant of Claim 38, wherein the implant is configured to secure a tensioned element used for an ACL surgery.

52. The intelligent implant of Claim 51, wherein the receptacle is a through hole formed in the tibia and configured to receive the tensioned element comprising an ACL graft.

53. The intelligent implant of Claim 51, wherein the receptacle is formed in the tibia and is configured to receive the tensioned element comprising a rope or a suture.

54. The intelligent implant of Claim 38, wherein the implant comprises a plate portion configured to extend out of the receptacle and along the bone after implantation.

55. The intelligent implant of Claim 54, wherein the plate portion is configured to interface with a surface of the bone.

56. An intelligent implant for implanting into a receptacle of a bone during an ACL surgery, comprising: a cartridge comprising: an electronics assembly comprising at least one sensor, and a controller having a knee-specific module, the knee-specific moduleconfigured to collect kinematic data resulting from movement of a knee sensed by the at least one sensor; and a housing enclosing the electronics assembly; wherein the intelligent implant is configured to secure a tensioned element used for the ACL surgery within the receptacle.

57. The intelligent implant of Claim 56, wherein the receptacle is formed in the tibia.

58. The intelligent implant of Claim 56, wherein the kinematic data is indicative of a laxity of the knee.

59. The intelligent implant of Claim 56, wherein the kinematic data is indicative of a flexion and / or extension of the knee.

60. The intelligent implant of Claim 56, further comprising a securing insert coupled to the housing of the cartridge.

61. The intelligent implant of Claim 60, wherein the securing insert comprises a surface feature that enables the implant to associate with the receptacle to secure the implant in the receptacle.

62. The intelligent implant of Claim 61, wherein the surface feature comprises threads.

63. The intelligent implant of Claim 60, wherein the securing insert comprises an interference screw.

64. The intelligent implant of Claim 60, wherein the securing insert comprises a first channel for receiving the tensioned element and a second channel for receiving the cartridge.

65. The intelligent implant of Claim 56, wherein the housing of the cartridge comprises a surface feature that enables the implant to associate with the receptacle to secure the implant in the receptacle.

66. The intelligent implant of Claim 65, wherein the surface feature comprises threads.

67. The intelligent implant of Claim 65, wherein the surface feature is a keyed flange configured to be located at the cortical bone interface when the cartridge is implanted into the receptacle.

68. The intelligent implant of Claim 56, wherein the receptacle is a through hole formed in the tibia and configured to receive the tensioned element comprising an ACL graft.

69. The intelligent implant of Claim 56, wherein the receptacle is formed in the tibia and is configured to receive the tensioned element comprising a rope or a suture.

70. The intelligent implant of Claim 56, wherein the implant comprises a plate portion configured to extend out of the receptacle and along the bone after implantation.

71. The intelligent implant of Claim 70, wherein the plate portion is configured to interface with a surface of the bone.

72. A smart cartridge for subcutaneous implantation near a bone, comprising: an electronics assembly comprising at least one sensor, and a controller having a joint-specific module, the joint-specific module configured to collect kinematic data resulting from movement of a specific joint sensed by the at least one sensor; and a housing enclosing the electronics assembly; wherein the smart cartridge is configured to be subcutaneously implanted adjacent to a natural joint of a body.

73. The smart cartridge of Claim 72, wherein the joint-specific module comprises a knee module configured to collect kinematic data resulting from movement of a knee sensed by the at least one sensor.

74. The smart cartridge of Claim 73, wherein the kinematic data is indicative of a laxity of the knee.

75. The smart cartridge of Claim 73, wherein the kinematic data is indicative of a flexion and / or extension of the knee.

76. The smart cartridge of Claim 73, wherein the at least one sensor comprises one or more accelerometers, one or more gyroscopes, or a combination of one or more accelerometers and one or more gyroscopes.

77. The smart cartridge of Claim 72, wherein the cartridge is implanted distal to a proximal tibiofibular joint of a leg.

78. The smart cartridge of Claim 72, wherein the cartridge is implanted at least partially in an anterior compartment of a leg.

79. The smart cartridge of Claim 72, wherein the cartridge is implanted at least partially in a posterior compartment of a leg.

80. The smart cartridge of Claim 72, further comprising an antenna assembly coupled to the electronics assembly and extending from an end of the housing.

81. The smart cartridge of Claim 80, wherein: the antenna assembly comprises an antenna that couples to the electronics assembly, and a cap that covers the antenna; and the cartridge further comprises an external sensor associated with the cap and that couples to the electronics assembly.

82. The smart cartridge of Claim 72, wherein the cartridge is sterile.

83. The smart cartridge of Claim 72, wherein the housing comprises a securing mechanism to maintain a position of the cartridge when subcutaneously implanted.

84. The smart cartridge of Claim 72, wherein the cartridge is configured to be at least partially covered by a liner when implanted.

85. A method of monitoring a joint surgery in a patient, comprising: implanting a smart cartridge into a receptacle of a bone, where the bone is associated with a joint that has, or will have, a joint surgery, wherein the smart cartridge comprises: an electronics assembly comprising at least one sensor, and a controller having a joint-specific module, the joint-specific module configured to collect kinematic data resulting from movement of a specific joint sensed by the at least one sensor; and a housing enclosing the electronics assembly.

86. The method of Claim 85, wherein the housing comprises a surface feature that enables the smart cartridge to associate with the receptacle to secure the smart cartridge in the receptacle.

87. The method of Claim 86, wherein the surface feature comprises threads.

88. The method of Claim 86, wherein surface feature is a keyed flange configured to be positioned at the cortical bone interface when the smart cartridge is inserted in the receptacle.

89. The method of Claim 85, wherein the cartridge has a form factor that is configured to fit at least partially within the receptacle.

90. The method of Claim 85, wherein implanting the smart cartridge comprises inserting a securing feature into the receptacle such that the smart cartridge couples to the securing feature to secure the smart cartridge in the receptacle.

91. The method of Claim 89, wherein the securing feature is a threaded screw.

92. A method of monitoring a joint surgery in a patient, comprising: implanting an intelligent implant into a receptacle of a bone, where the bone is associated with a joint that has, or will have, a joint surgery, wherein the intelligent implant comprises: a cartridge comprising: an electronics assembly comprising at least one sensor, and a controller having a joint-specific module, the joint-specific module configured to collect kinematic data resulting from movement of a specific joint sensed by the at least one sensor; and a housing enclosing the electronics assembly.

93. The method of Claim 92, wherein the implant has a form factor that is configured to fit at least partially within the receptacle.

94. The method of Claim 92, wherein the intelligent implant comprises a securing feature configured to couple to the cartridge and secure the implant at least partially within the receptacle.

95. The method of Claim 94, wherein the securing feature is a threaded screw.

96. The method of Claim 94, wherein implanting the intelligent implant comprises inserting the securing feature into the receptacle before coupling the cartridge to the securing feature.

97. The method of Claim 94, wherein the cartridge is coupled to the securing feature before implanting the implant into the receptacle.

98. The method of Claim 92, wherein the housing comprises a surface feature that enables the cartridge to associate with the receptacle to secure the implant in the receptacle.

99. The method of Claim 92, wherein implanting the implant secures a tensioned element used for an ACL surgery within the receptacle.

100. The method of Claim 99, wherein the receptacle is a through hole formed in the tibia and configured to receive the tensioned element comprising an ACL graft.

101. The method of Claim 99, wherein the receptacle is formed in the tibia and is configured to receive the tensioned element comprising a rope or a suture.

102. The method of Claim 92, wherein the implant extends partially out of the receptacle when implanted into the receptacle.

103. A method of monitoring an ACL surgery in a patient, comprising: implanting a smart cartridge in or adjacent to a bone, where the bone is associated with a joint that has, or will have, an ACL surgery, wherein the smart cartridge comprises: an electronics assembly comprising at least one sensor, and a controller having a knee-specific module, the knee-specific module configured to collect kinematic data resulting from movement of a knee sensed by the at least one sensor; and a housing enclosing the electronics assembly; wherein the collected kinematic data is indicative of a laxity, a flexion, and / or an extension of the knee.

104. The method of Claim 103, wherein the smart cartridge is implanted into a receptacle of the bone.

105. The method of Claim 104, wherein implanting the smart cartridge comprises inserting a securing feature into the receptacle such that the smart cartridge couples to the securing feature to secure the smart cartridge in the receptacle.

106. The method of Claim 104, wherein the housing of the smart cartridge comprises a surface feature that enables the smart cartridge to associate with the receptacle to secure the smart cartridge in the receptacle.

107. The method of Claim 104, wherein implanting the smart cartridge secures a tensioned element used for the ACL surgery within the receptacle.

108. The method of Claim 107, wherein the receptacle is a through hole formed in the tibia and is configured to receive the tensioned element comprising an ACL graft.

109. The method of Claim 107, wherein the receptacle is formed in the tibia and is configured to receive the tensioned element comprising a rope or a suture.

110. The method of Claim 104, wherein the smart cartridge extends partially out of the receptacle when implanted into the receptacle.

111. The method of Claim 103, wherein the smart cartridge is subcutaneously implanted adjacent to the bone.

112. The method of Claim 111, wherein the smart cartridge is implanted distal to a proximal tibiofibular joint of a leg.

113. The method of Claim 111, wherein the smart cartridge is at least partially covered by a securing liner during subcutaneous implantation.

114. The method of Claim 103, wherein the bone is a tibia of the patient.

115. A smart cartridge for subcutaneous implantation into a host, comprising: an electronics assembly comprising a sensor, and a controller having a data-collection module, the data-collection module configured to collect kinematic data sensed by the sensor, where the data characterizes a movement of the host; and a housing enclosing the electronics assembly; wherein the smart cartridge is configured to be subcutaneously implanted at a location within the host.

116. The smart cartridge of Claim 115, wherein the host is a human.

117. The smart cartridge of Claim 115, wherein the location is adjacent to a bone.

118. The smart cartridge of Claim 115, wherein the location is adjacent to a bone, where the bone is a spinal bone, optionally selected from a cervical, thoracic, lumbar, sacrum and coccyx bone.

119. The smart cartridge of Claim 115, wherein the location is adjacent to a natural joint of a body of the host.

120. The smart cartridge of Claim 115, wherein the location is adjacent to a natural joint of a body of the host, and the joint is selected from an ankle, a knee, a hip, a wrist, an elbow, and a shoulder.

121. The smart cartridge of Claim 115, wherein the location is distal to a proximal tibiofibular joint of a leg.

122. The smart cartridge of Claim 115, wherein the location is at least partially in an anterior compartment of a leg.

123. The smart cartridge of Claim 115, wherein the location is at least partially in a posterior compartment of a leg.

124. The smart cartridge of Claim 115, wherein the movement is of a specific joint of the host.

125. The smart cartridge of Claim 115, wherein the data-collection module is a joint-specific module.

126. The smart cartridge of Claim 115 for subcutaneous implantation near a bone, comprising an electronics assembly comprising a sensor, and a controller having a joint-specific module, the joint-specific module configured to collect kinematic data resulting from movement of a specific joint sensed by the at least one sensor; and a housing enclosing the electronics assembly; wherein the smart cartridge is configured to be subcutaneously implanted adjacent to a natural joint of a body of the host.

127. The smart cartridge of Claim 115, wherein the data-collection module is a joint-specific module comprising a knee module configured to collect kinematic data resulting from movement of a knee sensed by the at least one sensor.

128. The smart cartridge of Claim 115, wherein the kinematic data is indicative of a laxity of the knee.

129. The smart cartridge of Claim 115, wherein the kinematic data is indicative of a flexion and / or extension of the knee.

130. The smart cartridge of Claim 115, wherein sensor comprises one or more accelerometers, one or more gyroscopes, or a combination of one or more accelerometers and one or more gyroscopes.

131. The smart cartridge of Claim 115, wherein the sensor comprises an external sensor, where the external sensor physically contacts the body of the host.

132. The smart cartridge of Claim 115, wherein the housing comprises no sharp features that could damage tissue in contact with the implanted smart cartridge.

133. The smart cartridge of Claim 115, wherein the housing comprises exclusively biocompatible materials that will not harm tissue in contact with the implanted smart cartridge.

134. The smart cartridge of Claim 115, wherein the housing comprises a biocompatible material selected from metal, silicone and parylene.

135. The smart cartridge of Claim 115, wherein the housing comprises a metal which covers the sensor and the controller, and a plastic or ceramic which covers an antenna.

136. The smart cartridge of claim 115 wherein the housing does not include a feature or mechanism for securing the smart cartridge to a bone of the body.

137. The smart cartridge of claim 115 wherein the housing is not configured to be secured to or otherwise associated with a medical implant or prosthesis located within the body.

138. The smart cartridge of claim 115 wherein the housing is not configured to be secured to or otherwise associated with a bone of the host.

139. The smart cartridge of Claim 115, wherein the housing comprises a securing mechanism to maintain a position of the cartridge when subcutaneously implanted.

140. The smart cartridge of Claim 115, wherein the housing comprises a securing mechanism to maintain a position of the cartridge when subcutaneously implanted within muscle of a host.

141. The smart cartridge of Claim 115, wherein the housing comprises a securing mechanism to maintain a position of the cartridge when it is subcutaneously implanted in the host at a location distant from a bone or implanted medical device or prosthesis of the host.

142. The smart cartridge of Claim 115, wherein the housing comprises a securing mechanism which functions only to maintain a position of the cartridge in the host when it is subcutaneously implanted in the host.

143. The smart cartridge of Claim 115, wherein the cartridge is configured to be at least partially covered by a liner when implanted.

144. The smart cartridge of claim 115, having a length of between 20 mm and 50 mm, a width of between 6 mm and 15 mm, and a depth of between 6 mm and 15 mm.

145. The smart cartridge of Claim 115, comprising a power component contained within the housing, where the power component provides power to the sensor.

146. The smart cartridge of Claim 115, wherein the power component is a battery.

147. The smart cartridge of Claim 115, further comprising an antenna assembly coupled to the electronics assembly, where the antenna assembly comprises an antenna.

148. The smart cartridge of Claim 115, wherein the antenna is selected from a wire antenna, a conformal antenna, and a planar antenna.

149. The smart cartridge of Claim 115, where the antenna extends from an end of the housing.

150. The smart cartridge of Claim 115, comprising a cap that covers the antenna, where the cap protects the antenna and allows radio frequency (RF) signals to propagate through the cap with acceptable levels of attenuation and other signal degradation.

151. The smart cartridge of claim 115, wherein the cap comprises polyether etherketone (PEEK).

152. The smart cartridge of Claim 115, wherein the cartridge further comprises an external sensor associated with a cap that covers an antenna of the smart cartridge, where the antenna couples to the electronics assembly.

153. The smart cartridge of Claim 115, wherein the cartridge is sterile.

154. A smart cartridge for collecting kinematic data from a subject, comprising: an electronics assembly comprising at least one sensor, and a controller configured to collect kinematic data resulting from movement of a knee sensed by the at least one sensor; and a housing enclosing the electronics assembly; wherein the smart cartridge is not connected to an artificial knee, hip, or shoulder prosthesis.

155. A smart cartridge for collecting kinematic data from a subject, comprising: an electronics assembly comprising at least one sensor, and a controller configured to collect kinematic data resulting from movement of a hip sensed by the at least one sensor; and a housing enclosing the electronics assembly; wherein the smart cartridge is not connected to an artificial knee, hip, or shoulder prosthesis.

156. A smart cartridge for collecting kinematic data from a subject, comprising: an electronics assembly comprising at least one sensor, and a controller configured to collect kinematic data resulting from movement of a shouldersensed by the at least one sensor; and a housing enclosing the electronics assembly; wherein the smart cartridge is not connected to an artificial knee, hip, or shoulder prosthesis.

157. A smart cartridge for collecting kinematic data from a subject, comprising: an electronics assembly comprising at least one sensor, and a controller configured to collect kinematic data resulting from movement of a vertebrae sensed by the at least one sensor; and a housing enclosing the electronics assembly; wherein the smart cartridge is not connected to an artificial knee, hip, or shoulder prosthesis.

158. A method of monitoring a movement of a host, the method comprising: selecting a host having a smart cartridge implanted at a location in the host, wherein the smart cartridge comprises an electronics assembly comprising a sensor and a controller having a data-collection module, where the data-collection module configured to collect kinematic data generated by the sensor, where the data characterizes a movement of the host, the smart cartridge further comprising a housing enclosing the electronics assembly; sensing the movement of the host with the sensor to generate kinematic data, where the kinematic data provides a characterization of the movement of the host; collecting the kinematic data in a memory enclosed by the housing to provide collected kinematic data; providing transmitted data by way of transmitting the collected kinematic data to a location outside of the housing and / or analyzing the collected kinematic data within the housing to provide movement information and transmitting the movement information to a location outside of the housing; analyzing the transmitted data to provide a characterization of the movement of the host.

159. The method of claim 158 wherein the host is a human.

160. The method of claim 158 wherein the host has a partial or total artificial joint.

161. The method of claim 158 wherein the host has an ACL injury and / or has hadACL surgery.

162. The method of claim 158 wherein the host has an abnormal gait.

163. The method of claim 158 wherein the host has a neurological disorder selected from Parkinson's disease, Alzheimer's disease, Huntington's Disease, cerebellar ataxia, multiple sclerosis, peripheral neuropathy, myelopathy, or a neurological disorder brought on by a stroke or a spinal cord injury.

164. The method of claim 158 wherein the host has an implanted smart cartridge secured directly to a bone of the host.

165. The method of claim 158 wherein the host has an implanted smart cartridge secured directly to a threaded insert, where the threaded insert is secured directly to the bone.

166. The method of claim 158, wherein the smart cartridge is located in a receptacle of the bone.

167. The method of claim 158, wherein the smart cartridge is located in a receptacle that has been formed in the exterior of the bone.

168. The method of claim 158, wherein the smart cartridge is located in a receptacle of a bone and extends partially out of the receptacle when implanted into the receptacle.

169. The method of claim 158, wherein the smart cartridge comprises a securing feature, wherein the smart cartridge and securing feature are inserted into a receptacle of a bone such that the smart cartridge couples to the securing feature to secure the smart cartridge in the receptacle.

170. The method of claim 158, wherein the housing of the smart cartridge comprises a surface feature that enables the smart cartridge to associate with a receptacle in a bone to secure the smart cartridge in the receptacle.

171. The method of claim 158, wherein the smart cartridge is located in a receptacle of a bone and wherein the implanted smart cartridge secures a tensioned element used for the ACL surgery within the receptacle.

172. The method of claim 158, wherein the smart cartridge is located in a receptacle of a bone and wherein the implanted smart cartridge secures a tensioned element used for the ACL surgery within the receptacle; and wherein the receptacle is a through hole formed in the tibia and is configured to receive the tensioned element comprising an ACL graft.

173. The method of claim 158, wherein the smart cartridge is located in a receptacle of the bone and wherein the implanted smart cartridge secures a tensioned element used for the ACL surgery within the receptacle; and wherein the receptacle is formed in the tibia and is configured to receive the tensioned element comprising a rope or a suture.

174. The method of claim 158, wherein the smart cartridge is located subcutaneously adjacent to a bone.

175. The method of claim 158, wherein the smart cartridge is located subcutaneously adjacent to a bone, where the bone is associated with a joint that has had or will have, an ACL surgery.

176. The method of claim 158, wherein the smart cartridge is located subcutaneously adjacent to a bone; and wherein the smart cartridge is implanted distal to a proximal tibiofibular joint of a leg.

177. The method of claim 158, wherein the smart cartridge is located subcutaneously adjacent to a bone; and wherein the smart cartridge is at least partially covered by a securing liner.

178. The method of claim 158, wherein the location is a leg of the host.

179. The method of claim 158, wherein the location is in a receptacle of a tibia of the host.

180. The method of claim 158, wherein the location is adjacent to a joint of the host.

181. The method of claim 158, wherein the location is adjacent to a tibia of the host.

182. The method of claim 158, wherein the kinematic data is indicative of a laxity, a flexion, and / or an extension of a knee of the host.

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