Smart implant for joint revision surgery

Abstract

A smart implant includes an implantable reporting processor (IRP) and a component of a prothesis system having a receptacle. The IRP includes an antenna, an electronics assembly including a sensor, a hermetically sealed chamber containing the electronics assembly, a casing configured to house at least a portion of the electronics assembly, and a cover configured to house the antenna. The casing and the cover may abut one another to form an antenna chamber that houses the antenna. The receptacle of the component is configured to receive the coupling region of the IRP and to mechanically couple with the implantable reporting processor. The component of the prothesis system may be one of a tibial component or a femoral component of a knee prosthesis system, a humeral component of a shoulder prosthesis system, and a femoral component of a hip prosthesis system.

Description

Docket No.: CANA.475PCSMART IMPLANT FOR JOINT REVISION SURGERYINCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS

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

[0002] The present disclosure relates generally to smart implants associated with implantable systems such as orthopedic (e.g., joint replacement systems), and more particularly, to smart implants with implantable reporting processors that sample, record, and transmit information related to the placement and integrity of an implanted system, and the health of the patient in which the system is implanted, as well as features of smart implants that render them particularly useful in knee revision surgery.BACKGROUND

[0003] Orthopedic replacement systems, such as knee arthroplasty systems, shoulder arthroplasty systems, hip arthroplasty systems, and spinal implant systems may be configured to replace the entirety of a knee, shoulder, or hip joint, or to replace a part of knee, shoulder, or hip. Systems intended to replace the entirety of a knee, shoulder, or hip joint are referred to as total joint replacement systems or total joint arthroplasty (TJA), while those intended to replace a part of a joint are referred to as partial joint replacement systems. In either case, these joint replacement systems include implant structures or components.

[0004] With reference to FIG. 1A, a total knee arthroplasty (TKA) typically consists of a femoral component, a tibial component, a tibial insert, a tibial stem extension and a patella component. The patella component, which is implanted in front of the joint, is not shown. Collectively, these five implant structures or components may be referred to as any one of an implantable medical device, a knee prosthetic system, or total knee implant (TKI). Each of these five components may also be individually referred to as an implantable medical device. These components are designed to work together as a functional unit, to replace and provide the function of a natural knee joint.Docket No.: CANA.475PC

[0005] With reference to FIG. IB, a standard total shoulder arthroplasty (TSA) typically consists of a humeral stem component, a humeral stem adapter, a humeral head, a humeral head adapter (not shown), and a glenoid cap component. Collectively, these four implant structures or components may be referred to as any one of an implantable medical device, a shoulder prosthetic system, or total shoulder implant (TSI). Each of these four components may also be individually referred to as an implantable medical device. These components are designed to work together as a functional unit, to replace and provide the function of a natural shoulder joint.

[0006] With reference to FIG. 1C, a total hip arthroplasty (THA) typically consists of a femoral stem component, a femoral head component, a head liner component, and an acetabular cap component. Collectively, these four implant structures or components may be referred to as any one of an implantable medical device, a hip prosthetic system, or total hip implant (THI). Each of these four components may also be individually referred to as an implantable medical device. These components are designed to work together as a functional unit, to replace and provide the function of a natural hip joint.

[0007] After the TJA has been implanted, and the patient begins to walk with the knee or hip prosthesis and move his arms or shoulder prosthesis, problems may occur and are sometimes hard to identify. In some instances, it is determined that a component of, or the entire TJA needs to be replaced. This replacement is achieved through a surgery known as revision surgery. In contrast, when the TJA is initially implanted in a patient, the surgical process is known as primary surgery.

[0008] Health care providers routinely require a stronger implant for a revision surgery as compared to the implant required for a primary surgery. The present disclosure is directed to various mechanical aspects of smart implants with implantable reporting processors that sample, record, and transmit information related to the placement and integrity of an implanted TJA, and the health of the patient in which the TJA is implanted, which are suitable for use in a revision surgery.SUMMARY

[0009] Briefly stated, the present disclosure relates to an implantable reporting processor (IRP), where the IRP is configured to function as a stem that may be coupled to and become part of a tibial component or a humeral component or a femoral component useful in a jointDocket No.: CANA.475PCreplacement system. Each of the IRP and the tibial / humeral / femoral component coupled to the IRP may be referred to as a smart implant. The IRP includes a casing and a cover. The casing is configured to house a power supply, where optionally the entire power supply is enclosed within the casing. The casing may be metallic. The cover is configured to house an antenna, optionally the entire antenna is enclosed within the cover. The cover should not preclude wireless information from passing through the cover, and may be non-metallic, e.g., it may be organic, such as an organic polymer, e.g., a plastic. The cover is configured to house an antenna that is electrically coupled to an electronics assembly, where the power supply provides power to the electronics assembly. The electronics assembly may be entirely enclosed by the metallic casing, or it may be entirely enclosed by the non-metallic cover, or it may be partially enclosed by the metallic casing and partially enclosed by the non-metallic cover.

[0010] The present disclosure also relates to an IRP that includes an antenna, an electronics assembly including a sensor, a casing configured to house the electronics assembly, and a cover. The cover is configured to house the antenna, and is sufficiently strong that it can withstand anatomical fatigue loading resulting from forces exerted on the cover after the IRP has been implanted in a bone of a subject and the subject performs normal daily activity.

[0011] The present disclosure also relates to an IRP that includes a casing, a battery, an antenna configured to transmit data, and an electronics assembly at least partially enclosed by the casing. The electronics assembly may include a flexible circuit assembly, a liner, and a sleeve. The circuit assembly is coupled to the power source, e.g., a battery and to the antenna, and is configured to generate data based on input from the sensor of the electronics assembly. The flexible circuit assembly includes a first portion and a second portion that can be folded to overlap each other. The liner includes a first section configured to receive the first portion of the flexible circuit assembly and a second section configured to receive the second portion of the flexible circuit assembly. When the flexible circuit assembly is folded, the liner encloses the flexible circuit assembly. The sleeve is configured to enclose the liner, and includes a distal rim configured to abut a proximally facing surface of the casing.

[0012] The present disclosure also relates to an IRP that includes an antenna, an electronics assembly including a sensor, a hermetically sealed chamber containing theDocket No.: CANA.475PCelectronics assembly, a casing configured to house at least a portion of the electronics assembly, and a cover configured to house the antenna. The hermetically sealed chamber may contain a gas.

[0013] The present disclosure also relates to an IRP that includes an antenna, an electronics assembly including a sensor, a casing configured to house at least a portion of the electronics assembly at least partially within a hermetically sealed chamber, and a cover configured to house the antenna. The casing and the cover abut one another to form an antenna chamber that houses the antenna and optionally a filler that fills the space between the antenna and the inside of the cover.

[0014] The present disclosure also relates to a smart implant that includes an IRP as described in any of the preceding paragraphs, and a component of a prothesis system having a receptacle. The receptacle is configured to receive a portion of the IRP and to mechanically couple with the IRP. The component of the prothesis system may be one of a tibial component or a femoral component of a knee prosthesis system, a humeral component of a shoulder prosthesis system, and a femoral component of a hip prosthesis system.

[0015] The coupling feature of the IRP may be solid in that it does not contain an empty cavity. The coupling feature of the IRP may be characterized as not containing any of a power source, an electronics assembly, or an antenna. The coupling feature of the IRP is desirably solid rather than hollow in order for the coupled IRP + prosthesis to be sufficiently strong to provide satisfactory performance for a patient who has undergone a revision surgery to implant the IRP + prosthesis. When the coupling feature is not solid, e.g., when it contains a channel orcavity, then the coupling feature has reduced strength, i.e., reduced ability to resist bending or breaking, as may be more likely to happen when the IRP + prosthesis is utilized in a revision surgery, i.e., to replace a previously implanted prosthesis or portion thereof as compared to use in a primary surgery, i.e., implanting a prothesis or portion thereof into a bone which has not previously contained an implanted prosthesis.

[0016] The present disclosure also relates to a smart implant that includes a component of a prosthesis system (e.g., a tibial component) and an IRP coupled to the component. Optionally, the IRP has a casing that includes a shoulder and a proximal end, and a proximal portion located between the shoulder and the proximal end. The proximal portion comprises a coupling region having an indent that is annularly symmetrical around a perimeter of theDocket No.: CANA.475PCcoupling region. The coupling region may be solid metal, e.g., the coupling region does not have an internal cavity, or the coupling region does not include any of a power source, an electronics assembly or an antenna.

[0017] The smart implant of the present disclosure may include a strengthening region, where the strengthening region enhances the crumple resistance of the smart implant compared to the crumple resistance of a smart implant lacking the strengthening region. Thus, in one aspect, the present disclosure provides an implantable reporting processor (IRP) comprising: an antenna, an electronics assembly comprising a sensor, a power supply, and a coupling region, the coupling region configured to mate with and secure the IRP to a receptacle of a tibial plate or a stemmed (also referred to as keeled) tibial plate; where the IRP further comprises a strengthening region located between the coupling region and the power supply; and where the strengthening region enhances the crumple resistance of the IRP compared to the crumple resistance of an IRP lacking the strengthening region. In embodiments, the strengthening region (region B in FIG. 3) has a length of between 5 mm and 25 mm, or between 5 mm and 35 mm, or between 5 mm and 45 mm, or at least 5 mm, or at least 7 mm, or at least 9 mm, or at least 11 mm, or at least 13 mm, or at least 15 mm, or at least 17 mm, or at least 19 mm.

[0018] Although the IRP and the implantable system including the IRP as disclosed herein are described as being suitable for a joint revision surgery, the IRP and implantable system are also suitable for use in a primary joint surgery.

[0019] 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 Brief 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

[0020] 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, theDocket No.: CANA.475PCshapes 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:

[0021] FIG. 1A is an illustration of a conventional implantable medical device, also referred to as an implantable system, in the form of a knee prosthetic system, or total knee implant (TKI).

[0022] FIG. IB is an illustration of a conventional implantable medical device, also referred to as an implantable system, in the form of a shoulder prosthetic system, or total shoulder implant (TSI).

[0023] FIG. 1C is an illustration of a conventional implantable medical device, also referred to as an implantable system, in the form of a hip prosthetic system, or total hip implant (THI).

[0024] FIGS. 2A and 2B are illustrations of a smart implant in the form of a tibial component of a knee prosthesis including a stemmed tibial plate and a long-extension implantable reporting processor extending from a tibial stem.

[0025] FIG. 3 is an illustration of a smart implant in the form of a tibial component of a knee prosthesis including identification of specific regions of the tibial component.

[0026] FIG. 4 is a block diagram of an implantable reporting processor (IRP).DETAILED DESCRIPTION

[0027] The present disclosure may be understood more readily by reference to the following detailed description of embodiments of the disclosure and the examples of implantable medical devices with implantable reporting processors. The following description, along with the accompanying drawings, sets forth certain specific details in order to provide a thorough understanding of various disclosed embodiments. However, one skilled in the relevant art will recognize that the disclosed embodiments may be practiced in various combinations, without one or more of these specific details, or with other methods, components, devices, materials, etc. In other instances, well-known structures or components that are associated with the environment of the present disclosure, includingDocket No.: CANA.475PCbut not limited to the communication systems and networks, have not been shown or described in order to avoid unnecessarily obscuring descriptions of the embodiments.

[0028] The present disclosure refers to TJA (total joint arthroplasty) which term includes reference to the surgery and associated implantable medical devices such as a TJA prosthesis. Features of methods, devices and systems of the present disclosure may be illustrated herein by reference to a specific TJA prosthesis, however, the disclosure should be understood to apply to any one or more TJA prosthesis, including a TKA (total knee arthroplasty) prosthesis, such as a TKI (total knee implant) which may also be referred to as a TKA system; a TSA (total shoulder arthroplasty) prosthesis, such as a TSI (total shoulder implant) which may also be referred to as a TSI system; and a THA (total hip arthroplasty) prosthesis, such as a THI (total hip implant) which may also be referred to as a THA system.

[0029] An "implantable medical device" or "implantable system" as used in the present disclosure, refers to an implantable or implanted medical device that desirably replaces or functionally supplements a subject's natural body part. Examples of implantable medical devices include orthopedic implants such as knee, hip, and shoulder implants. The implantable medical device may include a fixation stem to which an IRP as disclosed herein may be coupled to secure the IRP to the implantable medical device. For example, the implantable medical device may be a stemmed tibia plate.

[0030] As used herein, the term "smart implant" refers to an implantable medical device (IMD) that includes an implantable reporting processor (IRP) and is interchangeably referred to a smart implant or a smart device. When the smart implant makes kinematic measurements, it may be referred to as a "kinematic implantable device." In describing embodiments of the present disclosure, reference may be made to a kinematic implantable device, however it should be understood that this is exemplary only of the smart medical devices which may be employed in the devices, methods, systems etc. of the present disclosure.

[0031] In one embodiment, the smart implant is suitable for use in joint revision surgery. For example, it is suitable for use in a knee revision surgery, and this example will be described herein for convenience and clarity, however the description is applicable to hip and shoulder revision surgery implants as well. In a knee revision surgery, a previously implanted tibial plate is removed from a patient, where this previously implanted tibial plate is commonlyDocket No.: CANA.475PCreferred to as a primary tibial plate in the situation where the patient received the tibial plate for the first time. If the patient is receiving a replacement tibial plate, then the surgery to achieve this replacement is commonly referred to as revision surgery, e.g., revision knee surgery or revision total knee replacement. In the case of a revision surgery, the replacement IMD or IMD / IRP is referred to as a revision implant.

[0032] A revision implant is expected by health care providers (HCPs) and / or patients to meet certain existing industry standards of performance. In some respects, the performance criteria of a revision implant is greater than the performance criteria of a primary implant. One example is the strength of a stemmed IMD, and in particular the resistance of the stemmed IMD to break under pressure. This resistance may be measured by fatigue testing, such as by cantilever fatigue testing. See, e.g., ASTM F1800-12. Standard Test Method for Cyclic Fatigue Testing of Metal Tibial Tray Components of Total Knee Joint Replacements (2012) and ISO 14879-1. Implants for surgery - Total knee - joint prostheses. Part 1: Determination of endurance properties of knee tibial trays (2020).

[0033] A medical implant that does not contain any sensors or electronics may in some situations be made entirely from a single piece of appropriately fabricated metal. However, when a sensor and electronic components are added to the IMD, to achieve a smart implant, the presence of those components may degrade the strength properties of the IMD. In other words, an IMD with an electronics assembly, power source etc. may not have the desired strength properties that are present in an IMD lacking those features.

[0034] The present disclosure provides an implantable medical device with a sensor, an electronics assembly and a power source which has superior strength properties compared to known implantable medical devices with a sensor, an electronics assembly and a power source. FIGS. 2A and 2B are illustrations of a smart implant in the form of a tibial component of a knee prosthesis including a tibial plate and a long-extension implantable reporting processor extending from a tibial stem. These illustrations show how an IRP may be combined with a stemmed tibial plate. FIG. 2B shows a plate 106 having a stem 110. FIG. 2B also shows an IRP 104 near a hole 112 in the stem 110 (sometimes referred to as a keel). The IRP 104 can fit partially within the stem cavity made available via the hole 112 to provide the combination 102 shown in FIG. 2A. In FIG. 2A, the IRP 104 has been inserted partially into the hole 112 of the stem 110 which is part of the plate 106. This combination 102 then goes intoDocket No.: CANA.475PCthe intramedullary canal of the tibia of the leg 109. Some amount of the IRP 104 goes into the cavity of the stem and some of the IRP 104 extends outward from the stem, effectively lengthening the stem of the tibial plate.

[0035] The connection between the IRP 104 and the stem 110 can be a weak point for the combination 102. When excessive stress is placed on the implanted combination 102, particularly in a side-ways direction, the breaking point of the combination is typically the region where the tibial stem connects with the IRP. The present disclosure addresses this problem, which is particularly problematic for patients with weakened bones who may have already undergone a TKA and are in need of revision surgery and suitable implantable systems.

[0036] In some cases a physician or surgeon may determine that for some patients an IRP 104 is not desirably secured directly to the stem 110. This may be because the angle at which the tibial plate 106 is most desirably secured to the top of the tibia causes the stem to point in a direction that is not directly down the center of the intramedullary canal. In such cases, the surgeon may place a so-called offset adapter between the stem 110 and the IRP 104, where the offset adapter adjusts the angle at which the IRP 104 is secured to the stem 110, such that that angle is not 180 degrees, but is instead less than 180 degrees. In this event, the IRP 104 is placed partially through a hole of the offset adapter and into a receiving cavity of the adapter, rather than directly through the hole of the tibial stem. Whether the IRP 104 is placed directly into the offset adapter or directly into the stem, the IRP of the present disclosure provides enhanced strength for the implanted combination so that side-ways pressures are better tolerated without breakage or cracking of the implanted combination. This beneficial effect may depend, in part, on the manner in which the IRP is secured to the offset adapter or the stem, where in one embodiment the IRP of the present disclosure is secured to the offset adapter or the tibial stem by force fitting an exterior surface of the IRP 104 against a complementarily shaped and sized interior surface of the stem 110, to provide for force fitting of the two pieces to form the combination. The two pieces are then held together, at least in part, by frictional forces. The mating surfaces may each be a tapered surface, to provide for force fitting of mated tapered surfaces in creating the mated combination.Docket No.: CANA.475PC

[0037] An exemplary IRP of the present disclosure is shown in FIG. 3. In FIG. 3, the IRP 100 is a stem for coupling to a stemmed implantable medical device. For example, the IRP 100 may be a stem to be coupled to a stemmed tibial plate (not shown in FIG. 3) which is sometimes referred to as a keeled tibial plate. Functionally different regions of the IRP 100 are separated by dashed lines, as shown in FIG.3, and are identified as A, B, C, D and E. The region A may be referred to as the proximal end of the IRP 100 and the region E may be referred to as the distal end of the IRP 100.

[0038] At the distal end of the IRP 100 is region E, which is the location of an antenna. The antenna is used, for example, for sending data that is obtained from the IRP to a location outside of the IRP. Next to the antenna is region D, which is the location of an electronics assembly. The electronics assembly includes one or more sensors as well as a memory for storing the data obtained by the sensors until such time as the stored data is transmitted via the antenna of region E to a location outside of the IRP. Next to the region D is a power source, which is located in region C. The power source provides power as needed to operate the electronics assembly and to transmit the sensor data to a location outside of the IRP. The power source may be, e.g., a battery, either a rechargeable or a non-rechargeable battery.

[0039] Region A is the location of the coupling feature of the IRP 100. The IRP coupling feature is configured to mate with a complementarily shaped and sized coupling feature in the stemmed medical device. In one embodiment of the disclosure, and as illustrated in FIG.3, the region A does not contain any electronic components, nor does it contain a power supply. In FIG. 3, region A is not shown as including a cavity, and in one embodiment of the disclosure, and as illustrated in FIG. 3, the region A does not contain any cavity.

[0040] Region B is located between the regions C and A. Region B is an optional region of a smart implant of the present disclosure. Region B does not enter the stem of a stemmed implantable medical device but instead is located just outside of the stem receptacle when the IRP is coupled to a stemmed implant. In one embodiment of the IRP, region B does not contain any electronics in the form of an antenna, an electronics assembly or a power source. In one embodiment of the IRP, region B does not contain any cavity into which any electronic items may be located, and the region B of the IRP may be described as being solid. The region B of the IRP may be solid in that it does not contain an empty cavity. The region B of the IRP may be characterized as not containing any of a power source, an electronics assembly, or anDocket No.: CANA.475PCantenna. The region B of the IRP is desirably solid ratherthan hollow in orderforthe coupled IRP + prosthesis to be sufficiently strong to provide satisfactory performance for a patient who has undergone a revision surgery to implant the IRP + prosthesis. When the region B is present but not solid, e.g., when region B contains a channel or cavity, then the region B portion of the IRP has reduced ability to resist bending or breaking, as may be more likely to happen when the IRP + prosthesis is utilized in a revision surgery, i.e., to replace a previously implanted prosthesis or portion thereof. In one embodiment, the IRP has a solid region B and a solid region A.

[0041] Although region B is shown being shorter than, e.g., regions C or A, the relative lengths of each of the regions are not necessarily drawn to scale in FIG. 3. In fact, region B may optionally be the longest of the regions A, B, C, D and E. In one embodiment, Regions E, D and C together may have a total length of about 30 to 50 mm. In one embodiment, Region A has a length of about 20-30 mm, the majority of which (e.g., 20 mm) will be directly coupled to and perhaps fitted within the stemmed medical device while a minority portion of region A (e.g., 5 mm) may optionally extend outside of the stem of the stemmed medical implant (when the IRP stem 100 and the stemmed (also known as keeled) medical implant are coupled together) and be adjacent to Region B. In embodiments, Region B has a length of at least 5 mm, or at least 7 mm, or at least 9 mm, or at least 11 mm, or at least 13 mm, or at least 15 mm, or at least 17 mm, or at least 19 mm. A surgeon may elect an IRP 100 having relatively longer Region B in those situations, e.g., when the patient's tibia is not very strong or healthy, and the surgeon wants to increase the amount of contact between the implant and the bone so that greater bone-implant strength can develop upon bone growth.

[0042] The diameter of the IRP 100 may be constant or it may vary along the length of the IRP. Particularly when the IRP has a relatively long length, the surgeon may prefer that the distal end of the IRP has a smaller diameter than the proximal end of the IRP because the tibia tends to have a reduced diameter as it approaches the ankle.

[0043] Thus, in embodiments of the present disclosure, an IRP and the associated implantable system includes regions A, B, C and E, where electronic components selected from an antenna, an electronics assembly, and a power source are present in regions E, D and C but not in region A, and not in region B if present.Docket No.: CANA.475PC

[0044] The smart implant of FIG. 3 may be prepared starting from a single piece of metal, for example, titanium. A cavity is drilled into the center of the piece of metal, from the distal end (region E) towards the proximal end (region A). The cavity is present in regions E, D and C but is not present in regions B (if present) or A. Metal fabrication may be used to shape the coupling feature present in region A to a desired shape. As no cavity is drilled into region A, the region A consists of a solid piece of metal.

[0045] In one embodiment, the smart implant is an implanted or implantable medical device having an implantable reporting processor arranged to perform the functions as described herein. The smart implant may perform one or more of the following exemplary actions in orderto characterize the post-implantation status of the smart implant: identifying the smart implant or a portion of the smart implant, e.g., by recognizing one or more unique identification codes forthe smart implant ora portion of the smart 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 smart implant or a portion of the smart implant and wherein such data may optionally be collected as a function of time; storing the collected data within the smart implant or a portion of the smart implant; and communicating the collected data and / or the stored data by a wireless means from the smart implant or a portion of the smart 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 cloudbased storage system, or another computing device that has access to such storage.

[0046] Non-limiting and non-exhaustive list of embodiments of smart implants include components of a total knee arthroplasty (TKA) system, a total hip arthroplasty (THA) system, a total shoulder arthroplasty (TSA) system, an intramedullary rod for arm or leg breakage repair, a scoliosis rod, a dynamic hip screw, spinal implants (e.g., a spinal fusion implant such as a spinal interbody cage, rod or plate, or a spinal non-fusion implant such as an artificial disc or expandable rod).

[0047] 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 implantableDocket No.: CANA.475PCdevice, 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.

[0048] 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 smart kinematic implants obtains kinematic data, and optionally only obtains only kinematic data.

[0049] "Sensor" refers to a device that can be utilized to do one or more of detect, measure and / or monitor one or more different aspects of a body tissue (anatomy, physiology, metabolism, and / or function) and / or one or more aspects of the orthopedic device or implant. Representative examples of sensors suitable for use within the present disclosure include, for example, fluid pressure sensors, fluid volume sensors, contact sensors, position sensors, pulse pressure sensors, blood volume sensors, blood flow sensors, chemistry sensors (e.g., for blood and / or other fluids), metabolic sensors (e.g., for blood and / or other fluids), accelerometers, mechanical stress sensors and temperature sensors. Within certain embodiments the sensor can be a wireless sensor, or, within other embodiments, a sensor connected to a wireless microprocessor. Within further embodiments one or more (including all) of the sensors can have a Unique Sensor Identification number ("USI") which specifically identifies the sensor. In certain embodiments, the sensor is a device that can be utilized toDocket No.: CANA.475PCmeasure in a quantitative manner, one or more different aspects of a body tissue (anatomy, physiology, metabolism, and / or function) and / or one or more aspects of the orthopedic device or implant. In certain embodiments, the sensor is an accelerometerthat can be utilized to measure in a quantitative manner, one or more different aspects of a body tissue (e.g., function) and / or one or more aspects of the orthopedic device or implant (e.g., alignment in the patient).

[0050] A wide variety of sensors (also referred to as Microelectromechanical Systems or "MEMS," or Nanoelectromechanical Systems or "NEMS," and BioMEMS or BioNEMS, see generally https: / / en.wikipedia.org / wiki / MEMS) can be utilized within the present disclosure. Representative patents and patent applications include U.S. Patent Nos. 7,383,071, 7,450,332; 7,463,997, 7,924,267 and 8,634,928, and U.S. Publication Nos. 2010 / 0285082, and 2013 / 0215979. Representative publications include "Introduction to BioMEMS" by Albert Foch, CRC Press, 2013; "From MEMS to Bio-MEMS and Bio-NEMS: ManufacturingTechniques and Applications by Marc J. Madou, CRC Press 2011; "Bio-MEMS: Science and Engineering Perspectives, by Simona Badilescu, CRC Press 2011; "Fundamentals of BioMEMS and Medical Microdevices" by Steven S. Saliterman, SPIE-The International Society of Optical Engineering, 2006; "Bio-MEMS: Technologies and Applications", edited by Wanjun Wang and Steven A. Soper, CRC Press, 2012; and "Inertial MEMS: Principles and Practice" by Volker Kempe, Cambridge University Press, 2011; Polla, D. L., et al., "Microdevices in Medicine," Ann. Rev. Biomed. Eng. 2000, 02:551-576; Yun, K. S., et al., "A Surface-Tension Driven Micropump for Low-voltage and Low-Power Operations," J. Microelectromechanical Sys., 11:5, October 2002, 454-461; Yeh, R., et al., "Single Mask, Large Force, and Large Displacement Electrostatic Linear Inchworm Motors," J. Microelectromechanical Sys., 11:4, August 2002, 330-336; and Loh, N. C., et al., "Sub-10 cm3 Interferometric Accelerometer with Nano-g Resolution," J. Microelectromechanical Sys., 11:3, June 2002, 182-187; all of the above of which are incorporated by reference in their entirety.Smart Implants

[0051] The present disclosure provides smart implants, e.g., an implantable medical device with an implantable reporting processor (IRP). When the smart implant is included in a component of an implant system that replaces a joint, the smart implant can monitor displacement or movement of the component or implant system. The smart implant can alsoDocket No.: CANA.475PCprovide kinematic data that can be used to assess the mobility and health of the patient in which the system is implanted.

[0052] With reference to the block diagram of FIG. 4, an implantable reporting processor 1003 includes an electronics assembly 1010, a battery 1012 or other suitable implantable power source, and an antenna 1030. The electronics assembly 1010 comprises a circuit assembly that includes a fuse 1014, switches 1016, 1017, and 1018, a clock generator and clock and power management circuit 1020, an inertial measurement unit (IMU) 1022, a memory circuit 1024, a radio-frequency (RF) transceiver 1026, an RF filter 1028 and a controller 1032. The electronics assembly 1010 may also include an accelerometer 1023. The accelerometer 1023 may be a single axis or multi-axis accelerometer, and in one embodiment is a triaxial accelerometer. Examples of some or all of these components are described elsewhere in this application and in PCT Publication Nos. WO 2017 / 165717 and WO 2020 / 247890, which are incorporated by reference.

[0053] The battery 1012 can be any suitable battery, such as a Lithium Carbon Monofluoride (LiCFx) battery, or other storage cell configured to store energy for powering the electronics assembly 1010 for an expected lifetime (e.g., 5 - 25+ years) of the smart implant.

[0054] The fuse 1014 can be any suitable fuse (e.g., permanent) or circuit breaker (e.g., resettable) configured to prevent the battery 1012, or a current flowing from the battery, from injuring the patient and damaging the battery and one or more components of the electronics assembly 1010. For example, the fuse 1014 can be configured to prevent the battery 1012 from generating enough heat to burn the patient, to damage the electronics assembly 1010, to damage the battery, orto damage structural components of the kinematic implant.

[0055] The switch 1016 is configured to couple the battery 1012 to, or to uncouple the battery from, the IMU 1022 in response to a control signal 1034 from the controller 1032. For example, the controller 1032 may be configured to generate the control signal 1034 having an open state that causes the switch 1016 to open, and, therefore, to uncouple power from the IMU 1022, during a sleep mode or other low-power mode to save power, and, therefore, to extend the life of the battery 1012. Likewise, the controller 1032 also may be configured to generate the control signal 1034 having a closed state that causes the switch 1016 to close,Docket No.: CANA.475PCand therefore, to couple power to the IMU 1022, upon "awakening" from a sleep mode or otherwise exiting another low-power mode. Such a low-power mode may be for only the IMU 1022 or for the IMU and one or more other components of the implantable reporting processor 1003.

[0056] The switch 1017 is configured to couple the battery 1012 to, or to uncouple the battery from, the accelerometer 1023 in response to a control signal 1036 from the controller 1032. For example, the controller 1032 may be configured to generate the control signal 1036 having an open state that causes the switch 1017 to open, and, therefore, to uncouple power from the accelerometer 1023, during a sleep mode to save power, and, therefore, to extend the life of the battery 1012. Likewise, the controller 1032 also may be configured to generate the control signal 1036 having a closed state that causes the switch 1017 to close, and therefore, to couple power to the accelerometer 1023, upon "awakening" from a sleep mode.

[0057] The switch 1018 is configured to couple the battery 1012 to, or to uncouple the battery from, the memory circuit 1024 in response to a control signal 1038 from the controller 1032. For example, the controller 1032 may be configured to generate the control signal 1038 having an open state that causes the switch 1018 to open, and, therefore, to uncouple power from the memory circuit 1024, during a sleep mode or other low-power mode to save power, and, therefore, to extend the life of the battery 1012. Likewise, the controller 1032 also may be configured to generate the control signal 1038 having a closed state that causes the switch 1018 to close, and therefore, to couple power to the memory circuit 1024, upon "awakening" from a sleep mode or otherwise exiting another low-power mode. Such a low-power mode may be for only the memory circuit 1024 or for the memory circuit and one or more other components of the electronics assembly 1010.

[0058] The clock circuit 1020 is configured to generate a clock signal for one or more of the other components of the electronics assembly 1010, and can be configured to generate periodic commands or other signals (e.g., interrupt requests) in response to which the controller 1032 causes one or more components of the implantable circuit to enter or to exit a sleep, or other low-power, mode. In some embodiments, the clock circuit 1020 is also configured to regulate the voltage from the battery 1012, and to provide a regulate powersupply voltage to some or all of the other components of the electronics assembly 1010. In these embodiments, the clock circuit 1020 may be referred to as a clock and powerDocket No.: CANA.475PCmanagement circuit.

[0059] The IMU 1022 has a frame of reference with coordinate x, y, and z axes, and can be configured to measure, or to otherwise quantify, linear acceleration that the IMU experiences along each of the x, y, and z axes, and angular velocity (or rotational motion) that the IMU experiences about each of the x, y, and z axes. Such a configuration of the IMU 1022 is at least a six-axis configuration, because the IMU 1022 measures six unique quantities, ax(g), ay(g), az(g), Qx(dps), Qy(dps), and Qz(dps). Alternatively, the IMU 1022 can be configured in a nine-axis configuration, in which the IMU can use the earth magnetic field to compensate for, or to otherwise correct for, accumulated errors in ax(g), ay(g), az(g), Qx(dps), Qy(dps), and Qz(dps). But in an embodiment in which the IMU measures acceleration and angular velocity over only short bursts (e.g., 0.10 - 100 seconds(s)), for many applications accumulated error typically can be ignored without exceeding respective error tolerances.

[0060] The IMU 1022 can include a respective analog-to-digital converter (ADC) for each of the x, y, and z accelerometers and gyroscopes. Alternatively, the IMU 1022 can include a respective sample-and-hold circuit for each of the x, y, and z accelerometers and gyroscopes, and as few as one ADC that is shared by the accelerometers and gyroscopes. Including fewer than one ADC per accelerometer and gyroscope can decrease one or both of the size and circuit density of the IMU 1022, and can reduce the power consumption of the IMU. But because the IMU 1022 includes a respective sample-and-hold circuit for each accelerometer and each gyroscope, samples of the analog signals generated by the accelerometers and the gyroscopes can be taken at the same or different sample times, at the same or different sample rates, and with the same or different output data rates (ODR).

[0061] The accelerometer 1023 is configured to monitor acceleration in a low power state. The accelerometer 1023 may be a single axis or multi-axis accelerometer, and in one embodiment is a triaxial accelerometer. In the case of a triaxial configuration, the accelerometer 1023 can include a respective ADC for each of the x, y, and z accelerometers. Alternatively, the accelerometer 1023 can include a respective sample-and-hold circuit for each of the x, y, and z accelerometers, and as few as one ADC that is shared by the accelerometers. Including fewer than one ADC per accelerometer can decrease one or both of the size and circuit density of the accelerometer 1023, and can reduce the power consumption of the accelerometer 1023. Based on acceleration signals it senses, theDocket No.: CANA.475PCaccelerometer 1023 can detect motion events. For example, the accelerometer can be configured to detect simple motion events, such as footsteps or shoulder swings, and to count such detections. The accelerometer can be configured to detect significant motion, such as a walking motion or arm swinging motion. The accelerometer 1023 is configured to provide a wake-up signal to the controller 1032 when significant motion is detected.

[0062] The memory circuit 1024 can be any suitable nonvolatile memory circuit, such as EEPROM or FLASH memory, and can be configured to store data written by the controller 1032, and to provide data in response to a read command from the controller.

[0063] The RF transceiver 1026 can be a conventional transceiver that is configured to allow the controller 1032 (and optionally the fuse 1014) to communicate with a base station (not shown in FIG. 4) configured for use with the kinematic implantable device. For example, the RF transceiver 1026 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.

[0064] The RF filter 1028 can be any suitable bandpass filter, such as a surface acoustic wave (SAW) filter or a bulk acoustic wave (BAW) filter. In some embodiment, the RF filter 1028 includes multiple filters and other circuitry to enable dual-band communication. For example, the RF filter 1028 may include a bandpass filter for communications on a MICS channel, and a notch filter for communication on a different channel, such as a 2.45GHz as described above with reference to FIG. 21.

[0065] The antenna 1030 can be any antenna suitable for the frequency band in which the RF transceiver 1026 generates signals for transmission by the antenna, and for the frequency band in which a base station generates signals for reception by the antenna. In some embodiments the antenna 1030 is configured as a flat ribbon loop antenna as described above with reference to FIGS. 20A-20E.

[0066] The controller 1032, which can be any suitable microcontroller or microprocessor, is configured to control the configuration and operation of one or more of the other components of the electronics assembly 1010. For example, the controller 1032 is configured to control the IMU 1022 to take measurements of movement of the implantable medicalDocket No.: CANA.475PCdevice with which the electronics assembly 1010 is associated, to quantify the quality of such measurements (e.g., is the measurement "good" or "bad"), to store measurement data generated by the IMU in the memory 1024, to generate messages that include the stored data as a payload, to packetize the messages, to provide the message packets to the RF transceiver 1026 for transmission to an external device, e.g. a base station. The controller 1032 may be configured to execute commands received from an external device via the antenna 1030, the RF filter 1028, and the RF transceiver 1026. For example, the controller 1032 can be configured to receive configuration data from a base station, and to provide the configuration data to the component of the electronics assembly 1010 to which the base station directed the configuration data. If the base station directed the configuration data to the controller 1032, then the controller is configured to configure itself in response to the configuration data. The controller 1032 may also be configured to execute data sampling by the IMU 1022 in accordance with one or more programmed sampling schedules, or in response to an on-demand data sampling command received from a base station. For example, as described later below, the implantable reporting processor 104 may be programmed to operate in accordance with a master sampling schedule and a periodic, e.g., daily, sampling schedule.

[0067] In one aspect the present disclosure provides an implantable reporting processor (IRP) comprising: an antenna, an electronics assembly comprising a sensor, a power supply, and a coupling region, the coupling region configured to mate with and secure the IRP to a receptacle of a tibial plate; wherein each of the electronics assembly and the power supply are fully contained within a cavity of the IRP; and none of the antenna, the electronics assembly or the power supply is located in the coupling region of the IRP.

[0068] Optionally, one or more features may further describe the IRP: wherein the coupling region comprises a metal, e.g., titanium; wherein the coupling region is composed of solid titanium; wherein the power supply is surrounded by metal, e.g., titanium; wherein the antenna is surrounded by organic polymer, e.g., a plastic such as PEEK; wherein the electronics assembly is surrounded by both metal, e.g., titanium, and organic polymer, e.g., a plastic such as PEEK; further comprising an outer casing that fully encloses the power supply and partially encloses the electronics assembly; wherein the outer casing is metallic, i.e., comprises a metal, e.g., titanium; wherein the outer casing is metallic, i.e., comprises a metal,Docket No.: CANA.475PCe.g., titanium, and the coupling region also comprises the metal, e.g., titanium; wherein the outer casing comprises a metal, e.g., titanium, and the coupling region also comprise the metal, e.g., titanium; wherein a continuous single piece of metal forms the outer casing and the coupling region; wherein the continuous single piece of metal comprises a cavity, wherein the power supply is fully contained within the cavity; wherein the electronics assembly is fully contained within the cavity, and optionally is adjacent to the power supply; wherein the electronics assembly is partially contained within the cavity and optionally is adjacent to the power supply; wherein the IRP has a length of between about 30 mm and 150 mm, or between 50 mm and 100 mm; the IRP further comprises a strengthening region located between the coupling region and the power supply; wherein the strengthening region has a length of between 5 mm and 25 mm; wherein the strengthening region has a length which is 5-50% of the length of the IRP; wherein the strengthening region of the IRP has a maximal cross-sectional distance, e.g., a diameter, of between 10 mm and 20 mm, or between 8 mm and 20 mm.

[0069] In addition, the present disclosure provides, in one aspect, an implantable system comprising the IRP as described herein fitted partially within a stemmed tibial plate. Optionally, one or more of the following features may further describe the implantable system: wherein the coupling region is fitted at least partially within the tibial plate; wherein the coupling region is fitted entirely within the stem of the stemmed tibial plate; and / or wherein no portion of any of the power supply, the electronics assembly or the antenna are fitted within the stemmed tibial plate.

[0070] In addition, the present disclosure provides, in one aspect, a method of performing a knee revision surgery, the method comprising implanting an IRP as described herein into a tibia of a patient.

[0071] In addition, the present disclosure provides, in one aspect, a method of performing a knee revision surgery, the method comprising coupling an implantable system comprising an IRP as described herein to a tibia of a patient, e.g., implanting the implantable system in the tibia.

[0072] In addition, the present disclosure provides, in one aspect, a method of monitoring the recovery of a patient who has undergone knee revision surgery, the method comprising obtaining kinematic data with a sensor contained within the electronics assembly of an IRP orDocket No.: CANA.475PCimplantable system comprising the IRP as described herein, storing the kinematic data in a memory contained within the electronics assembly, transmitting the stored kinematic data to a location outside of the IRP by way of the antenna. The method may optionally be further described by one or more of the following features: analyzing the data to characterize movement of the patient; and / or further providing the analyzed data to a health care provider.

[0073] In addition, the present disclosure provides, in one aspect, an implantable system comprising the IRP as described herein fitted partially within a receptacle of femoral component of a hip implant, to provide some or all of the stem of that femoral component. Optionally, one or more of the following features may further describe the implantable system: wherein the coupling region is fitted at least partially within a receptacle of a femoral component; wherein the coupling region is fitted entirely within a receptacle of a femoral component; and / or wherein no portion of any of the power supply, the electronics assembly or the antenna are fitted within a receptacle of a femoral component.

[0074] In addition, the present disclosure provides, in one aspect, a method of performing a hip revision surgery, the method comprising implanting an IRP as described herein into a femur of a patient.

[0075] In addition, the present disclosure provides, in one aspect, a method of performing a hip revision surgery, the method comprising coupling an implantable system comprising an IRP as described herein to a femur of a patient, e.g., implanting the implantable system in the femur.

[0076] In addition, the present disclosure provides, in one aspect, a method of monitoring the recovery of a patient who has undergone hip revision surgery, the method comprising obtaining kinematic data with a sensor contained within the electronics assembly of an IRP or implantable system comprising the IRP as described herein, storing the kinematic data in a memory contained within the electronics assembly, transmitting the stored kinematic data to a location outside of the IRP by way of the antenna. The method may optionally be further described by one or more of the following features: analyzing the data to characterize movement of the patient; and / or further providing the analyzed data to a health care provider.

[0077] In addition, the present disclosure provides, in one aspect, a method of making aDocket No.: CANA.475PCmedical device, e.g., an IRP. The method comprises providing a piece of metal to be fabricated. The piece of metal may be medical grade metal, such as medical grade titanium alloy. The piece of metal will have a proximal end which either is or will ultimately become the coupling region of the implant, and it will have a distal end which either is or will ultimately become the location for an antenna. The piece of metal will be fabricated as needed, e.g. by a CNC (computer numerically controlled) process. The method comprises drilling a hole in the piece of metal, the drilling starting at the distal end and proceeding toward the proximal end of the metal piece. The drilling creates an opening at the distal end of the metal piece, and a cavity inside of the metal piece. The cavity is configured to hold a power supply and an electronics assembly. The cavity extends from the opening towards but not into the region of the metal piece that is or will become the coupling region. The cavity may extend from the opening and through the metal piece up to the beginning of the coupling region. Or the cavity may extend from the opening and through the metal piece but the cavity stops some distance away from the start of the coupling region. This "distance away" corresponds to the length of a strengthening region as disclosed herein, which is adjacent to the coupling region.

[0078] After the metal piece has been fabricated by, e.g., CNC, a subassembly is placed into the cavity. The subassembly comprises a power source, such as a battery, and an electronics assembly, which will include a sensor, e.g., an accelerometer and / or a gyroscope and optionally a memory to store the data obtained from the sensor. The subassembly also comprises a header, also called a feed through, to which the antenna may be secured and through which the data obtained from the sensor may be passed to the antenna. The subassembly may be placed inside of a sleeve, e.g., a metal sleeve, that surrounds the power source and the electronics assembly. The subassembly, optionally with the sleeve, may be inserted through the opening and slid into the cavity where it is permanently positioned. The sleeve that surrounds the subassembly may be welded to the interior of the cavity to affix the subassembly in place within the cavity. The antenna may be joined to the header (also referred to as a feed through) and then the antenna is capped with a protective radome formed of an organic polymer to provide the fully formed medical implant. The electronics assembly and the power source are hermetically sealed within the fabricated methal pice. The fully formed medical implant may be sterilized using, e.g., ETO (ethylene oxide) exposure.

[0079] Thus, the present disclosure provides a method of fabricating a medical implant asDocket No.: CANA.475PCdescribed herein, e.g., an IRP. The method comprises providing a piece of stock medical grade metal which may be, for example, a titanium alloy. The piece has a proximal end which is or will become the coupling region of the medical implant, and a distal end which is or will become the location for the antenna. The method comprises creating a cavity in the piece, and creating an opening that connects the cavity to the exterior surface of the piece, the opening located at the distal end of the piece. The opening will typically be created first, giving the tooling access to the interior of the piece to create the cavity. The cavity extends from the opening towards the proximal end of the piece but does not extend into the coupling region of the metal piece or the portion of the metal piece that will become the coupling region. The method further comprises placing a power source such as a battery, and an electronics assembly in the cavity, optionally with a sleeve around the power source and the electronics assembly, and securing the power source and electronics assembly within the cavity. The method further comprises affixing an antenna to the subassembly and placing a protective radome around the antenna.

[0080] Optionally, the sleeve may be welded to the power source for extra stability. Optionally the sleeve may be welded to the metal piece for extra stability. Optionally a polymeric filler may be placed within the radome to help protect and stabilize the antenna.

[0081] The exterior surface of the piece may be fabricated to include a surface feature that aids in securing the piece fixedly within a bone, e.g., in the intramedullary canal of a tibia. Exemplary surface features are flutes and splines, where flutes are valleys that run along the length of the stem and which proceed inward from the surface, while splines are thin regions that extend outward from the exterior surface along the length of the stem, somewhat like fences. Flutes allow bone tissue to grow "into" the valleys of revision stem while splines provide secure separation from regions of bone tissue that grow around the revision stem. Other exemplary surface features may be categorized as surface texture or surface micotexture, created by impacting and slightly deforming the otherwise smooth exterior surface of the revision stem by, e.g., sand blasting or shot peening the surface, where such processes provide a roughened or uneven surface against which the growing bone tissue can achieve a large amount of surface contact of various angles although typically only a small amount of ingrowth due to the relatively small indentations achieved by the texturing process. Another exemplary surface feature is a porous coating that may be applied to theDocket No.: CANA.475PCsurface of the revision stem. A surface coating may be in the form of, e.g., an array of beads that accept bone ingrowth. A further exemplary surface feature is a chemically active surface coating such as a coating containing hydroxy appetite, which promotes bone growth.

[0082] The following are exemplary embodiments of the present disclosure, numbered for convenience.1. An implantable reporting processor (IRP) comprising:an antenna, an electronics assembly comprising a sensor, a power supply, and a coupling region, the coupling region configured to mate with and secure the IRP to a receptacle of a prosthesis selected from a tibial component, a humeral component and a femoral component, whereineach of the electronics assembly and the power supply are fully contained within a cavity of the IRP; andnone of the antenna, the electronics assembly or the power supply is located in the coupling region of the IRP.2. The IRP of embodiment 1 wherein the coupling region comprises a metal, e.g., titanium.3. The IRP of embodiment 1 wherein the coupling region is composed of solid titanium.4. The IRP of embodiments 1-3 wherein the power supply is surrounded by metal, e.g., titanium.5. The IRP of any of embodiments 1-4 wherein the antenna is surrounded by organic polymer, e.g., a plastic such as PEEK.6. The IRP of any of embodiments 1-5 wherein the electronics assembly is surrounded by both metal, e.g., titanium, and organic polymer, e.g., a plastic such as PEEK.7. The IRP of any of embodiments 1-6 further comprising an outer casing that fully encloses the power supply and partially encloses the electronics assembly.8. The IRP of embodiment 7 wherein the outer casing is metallic, i.e., comprises a metal, e.g., titanium.Docket No.: CANA.475PC9. The IRP of embodiment 8 wherein the outer casing is metallic, i.e., comprises a metal, e.g., titanium, and the coupling region also comprises the metal, e.g., titanium.10. The IRP of embodiment 8 wherein the outer casing comprises a metal, e.g., titanium, and the coupling region also comprises the metal, e.g., titanium.11. The IRP of embodiment 8 wherein a continuous single piece of metal forms the outer casing and the coupling region.12. The IRP of embodiment 11 wherein the continuous single piece of metal comprises a cavity, wherein the power supply is fully contained within the cavity.13. The IRP of embodiment 12 wherein the electronics assembly is fully contained within the cavity, and optionally is adjacent to the power supply.14. The IRP of embodiment 12 wherein the electronics assembly is partially contained within the cavity and optionally is adjacent to the power supply.15. The IRP of any of embodiments 1-14 wherein the IRP has a length of between 50 mm and 100 mm.16. The IRP of any of embodiments 1-15 further comprising a strengthening region located between the coupling region and the power supply, where the strengthening region is formed from solid metal.17. The IRP of embodiment 16 wherein the strengthening region has a length of between 5 mm and 25 mm.18. The IRP of embodiment 16 wherein the strengthening region has a length which is 5-50% of the length of the IRP.19. The IRP of embodiment 16 wherein the strengthening region of the IRP has a maximal cross-sectional distance, e.g., a diameter, of between 10 mm and 20 mm.20. An implantable system comprising the IRP of any one of embodiments 1-19 fitted partially within a stemmed tibial plate.21. The implantable system of embodiment 20 wherein the coupling region is fitted at least partially within the tibial plate.22. The implantable system of embodiment 20 wherein the coupling region is fitted entirely within the stem of the tibial plate.Docket No.: CANA.475PC23. The implantable system of any of embodiments 20-22 wherein no portion of any of the power supply, the electronics assembly or the antenna are fitted within the tibial plate.24. A method of performing a knee revision surgery, the method comprising implanting an IRP of any of embodiments 1-19 into a tibia of a patient.25. A method of performing a knee revision surgery, the method comprising coupling an implantable system of any of embodiments 20-23 to a tibia of a patient.26. A method of monitoring the recovery of a patient who has undergone knee revision surgery, the method comprising obtaining kinematic data with a sensor contained within the electronics assembly of an IRP of any of claims 1-19, or an implantable system of any of claims 20-23, storing the kinematic data in a memory contained within the electronics assembly, and transmitting the stored kinematic data to a location outside of the IRP by way of the antenna.27. The method of embodiment 26 further comprising analyzing the data to characterize movement of the patient.28. The method of embodiment 27 further comprising providing the analyzed data to a health care provider.29. A method of fabricating an IPR of any of embodiments 1-19, the method comprising providing a piece of stock medical grade metal, the piece having a proximal end which is or will become the coupling region of the medical implant, and a distal end which is or will become the location for the antenna, the method comprising creating a cavity in the piece, and creating an opening that connects the cavity to the exterior surface ofthe piece, the opening located at the distal end of the piece, the cavity extending from the opening towards the proximal end of the piece but not extending into the coupling region of the metal piece; the method further comprising placing a power source and an electronics assembly in the cavity, optionally with a sleeve around the power source and the electronics assembly, and securing the power source and electronics assembly within the cavity; the method further comprising affixing an antenna to the subassembly, and placing a protective radome around the antenna.Docket No.: CANA.475PC30. The method of embodiment 29, further comprising fabricating a strengthening region adjacent to the coupling region, the strengthening region being formed from solid metal.

[0083] In the embodiments disclosed herein, the IRP may alternatively be referred to as a medical implant, or an implantable medical device (IMD).

[0084] It is to be understood that although reference to and illustration of the IRP of the present disclosure has been made by use of tibial stem extensions, including tibial stem extensions needed in revision surgery, the IRP may instead be a humeral stem or a femoral stem which are secured to a humeral component and a femoral component, as shown in FIGS. IB and 1C, respectively to provide a smart implantable system.

[0085] 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.

[0086] Reference throughout this specification to "one embodiment" or "an embodiment" and variations thereof such as "a configuration" 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.

[0087] 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. 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 eitherone, both, orany 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 ideasDocket No.: CANA.475PCand one or more other alternative embodiments that include fewer than all of the associated items or ideas.

[0088] Unless the context requires otherwise, throughout the specification and claims that follow, the word "comprise" and synonyms and variants thereof such as "have" and "include," as well as variations thereof such as "comprises" and "comprising" are to be construed in an open, inclusive sense, e.g., "including, but not limited to." The term "consisting essentially of" limits the scope of a claim to the specified materials or steps, or to those that do not materially affect the basic and novel characteristics of the claimed invention.

[0089] 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 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.

[0090] In the foregoing description, certain specific details are set forth to provide a thorough understanding of various disclosed embodiments. However, one skilled in the relevant art will recognize that embodiments may be practiced without one or more of these specific details, or with other methods, components, materials, etc. In other instances, well-known structures associated with electronic and computing systems including client and server computing systems, as well as networks have not been shown or described in detail to avoid unnecessarily obscuring descriptions of the embodiments.

[0091] Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present invention, a limited number of the exemplary methods and materials are described herein. Generally, unless otherwise indicated, the materials for making the invention and / or its components may be selected from appropriate materials such as metal, metallic alloys, ceramics, plastics, etc.

[0092] 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 invention. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges is also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where theDocket No.: CANA.475PCstated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the invention.

[0093] For example, any concentration range, percentage range, ratio range, or integer range provided herein is to be understood to include the value of any integer within the recited range and, when appropriate, fractions thereof (such as one tenth and one hundredth of an integer), unless otherwise indicated. Also, any number range recited herein relating to any physical feature, such as polymer subunits, size, or thickness, are to be understood to include any integer within the recited range, unless otherwise indicated. As used herein, the term "about" means ± 20% of the indicated range, value, or structure, unless otherwise indicated.

[0094] All of the U.S. patents, U.S. patent application publications, U.S. patent applications, foreign patents, foreign patent applications and non-patent publications referred to in this specification and / or listed in the Application Data Sheet are incorporated herein by reference, in their entireties. Such documents may be incorporated by reference for the purpose of describing and disclosing, for example, materials and methodologies described in the publications, which might be used in connection with the presently described invention. The publications discussed above and throughout the text are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the inventors are not entitled to antedate any referenced publication by virtue of prior invention.

[0095] 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.

Claims

Docket No.: CANA.475PCCLAIMSWhat is claimed is:

1. An implantable reporting processor (IRP) comprising:an antenna, an electronics assembly comprising a sensor, a power supply, and a coupling region, the coupling region configured to mate with and secure the IRP to a receptacle of a prosthesis selected from a tibial component, a humeral component and a femoral component, whereineach of the electronics assembly and the power supply are fully contained within a cavity of the IRP; andnone of the antenna, the electronics assembly or the power supply is located in the coupling region of the IRP.

2. The IRP of claim 1 wherein the coupling region comprises a metal, e.g., titanium.

3. The IRP of claim 1 wherein the coupling region is composed of solid titanium.

4. The IRP of claim 1 wherein the power supply is surrounded by metal, e.g., titanium.

5. The IRP of claim 1 wherein the antenna is surrounded by organic polymer, e.g., a plastic such as PEEK.

6. The IRP of claim 1 wherein the electronics assembly is surrounded by both metal, e.g., titanium, and organic polymer, e.g., a plastic such as PEEK.

7. The IRP of claim 1 further comprising an outer casing that fully encloses the power supply and partially encloses the electronics assembly.

8. The IRP of claim 7 wherein the outer casing is metallic, i.e., comprises a metal, e.g., titanium.

9. The IRP of claim 8 wherein the outer casing is metallic, i.e., comprises a metal, e.g., titanium, and the coupling region also comprises the metal, e.g., titanium.

10. The IRP of claim 8 wherein the outer casing comprises a metal, e.g., titanium, and the coupling region also comprises the metal, e.g., titanium.

11. The IRP of claim 8 wherein a continuous single piece of metal forms the outer casing and the coupling region.

12. The IRP of claim 11 wherein the continuous single piece of metal comprises a cavity, wherein the power supply is fully contained within the cavity.Docket No.: CANA.475PC13. The IRP of claim 12 wherein the electronics assembly is fully contained within the cavity, and optionally is adjacent to the power supply.

14. The IRP of claim 12 wherein the electronics assembly is partially contained within the cavity and optionally is adjacent to the power supply.

15. The IRP of claim 1 wherein the IRP has a length of between 50 mm and 100 mm.

16. The IRP of claim 1 further comprising a strengthening region located between the coupling region and the power supply, where the strengthening region is formed from solid metal.

17. The IRP of claim 16 wherein the strengthening region has a length of between 5 mm and 25 mm.

18. The IRP of claim 16 wherein the strengthening region has a length which is 5-50% of the length of the IRP.

19. The IRP of claim 16 wherein the strengthening region of the IRP has a maximal cross-sectional distance, e.g., a diameter, of between 10 mm and 20 mm.

20. An implantable system comprising the IRP of any one of claims 1-19 fitted partially within a stemmed tibial plate.

21. The implantable system of claim 20 wherein the coupling region is fitted at least partially within the tibial plate.

22. The implantable system of claim 20 wherein the coupling region is fitted entirely within the stem of the tibial plate.

23. The implantable system of claim 20 wherein no portion of any of the power supply, the electronics assembly or the antenna are fitted within the tibial plate.

24. A method of performing a knee revision surgery, the method comprising implanting an IRP of any of claims 1-19 into a tibia of a patient.

25. A method of performing a knee revision surgery, the method comprising coupling an implantable system of any of claims 20-23 to a tibia of a patient.

26. A method of monitoring the recovery of a patient who has undergone knee revision surgery, the method comprising obtaining kinematic data with a sensor contained within the electronics assembly of an IRP of any of claims 1-19, or an implantable system of any of claims 20-23, storing the kinematic data in a memoryDocket No.: CANA.475PCcontained within the electronics assembly, and transmitting the stored kinematic data to a location outside of the IRP by way of the antenna.

27. The method of claim 26 further comprising analyzing the data to characterize movement of the patient.

28. The method of claim 27 further comprising providing the analyzed data to a health care provider.

29. A method of fabricating an IPR of any of claims 1-19, the method comprising providing a piece of stock medical grade metal, the piece having a proximal end which is or will become the coupling region of the medical implant, and a distal end which is or will become the location for the antenna, the method comprising creating a cavity in the piece, and creating an opening that connects the cavity to the exterior surface of the piece, the opening located at the distal end ofthe piece, the cavity extending from the opening towards the proximal end of the piece but not extending into the coupling region of the metal piece; the method further comprising placing a power source and an electronics assembly in the cavity, optionally with a sleeve around the power source and the electronics assembly, and securing the power source and electronics assembly within the cavity; the method further comprising affixing an antenna to the subassembly, and placing a protective radome around the antenna.

30. The method of claim 29, further comprising fabricating a strengthening region adjacent to the coupling region, the strengthening region being formed from solid metal.

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