Devices, systems and methods for monitoring artificial knee joint replacements

Abstract

To provide total artificial knee joint replacements and partial artificial knee joints allowing monitoring of knee joints.SOLUTION: Sensors are combined with at least one of a tibial component, a patellar prosthesis, and a femoral component.SELECTED DRAWING: Figure 5

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application No. 61 / 838,317, filed June 23, 2013, the disclosure of which is incorporated herein by reference in its entirety.

[0002] The present invention relates generally to knee replacement surgery, and more specifically to devices and methods for monitoring the performance of total knee replacements and partial knee prostheses. [Background technology]

[0003] Knee replacement is one of the most common orthopedic reconstructive surgery. It can typically be performed when a patient is unable to fully use the knee joint as a result of osteoarthritis, rheumatoid arthritis and other forms of arthritis (such as systemic lupus erythematosus, psoriatic arthritis), previous knee injuries (knee ligament tears (anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament and / or lateral collateral ligament) and meniscus tears), as well as sequelae of previous reconstructive surgery for the treatment of these diseases, articular cartilage damage, joint dislocation, intra-articular fracture, and infection. In general, surgery is indicated for the treatment of extreme or persistent joint pain, reduced range of motion, impaired gait and / or function, and impaired normal daily living activities, and is usually indicated when there is evidence of significant loss or degeneration of all or part of the articular cartilage of the knee joint.

[0004] The knee is generally divided into three "compartments": medial (the articular surface on the inside of the knee), lateral (the articular surface on the outside of the knee), and patellofemoral (the surface where the kneecap joins the femur). Knee replacements can be performed in a wide variety of forms, depending on the degree of damage and / or extent of disease. In a total knee replacement (TKR), both surfaces of the knee joint are replaced (i.e., the femoral and tibial articular surfaces of the joint are replaced with prosthetics). The patellar (kneecap) surface may or may not be replaced, depending on the extent of damage to the patella. In a partial knee replacement or unicompartmental knee replacement, only one or two of the medial, lateral, or patellofemoral parts of the joint are replaced (medial compartment replacement is most common).

[0005] The various components of a TKR usually include a femoral implant and a tibial implant (with or without replacement of the patellar surface). The femoral component consists of rounded femoral condyles (usually metal, but can be ceramic), the tibial component consists of a flat metal shell (with or without a stem extending into the tibial canal) that attaches to the tibia with a polymeric (usually polyethylene, but can also be ceramic or metal) inner liner, and the patellar component (if present) consists of a polymeric "button" bonded to the posterior surface of the patella. Currently, the various components of a TKR can be manufactured from a wide variety of materials, for example, polyethylene, ultra-high molecular weight polyethylene, ceramics, surgical stainless steel, cobalt chrome, titanium, and various ceramic materials. In some systems, the femoral implant (typically made of metal, such as stainless steel, titanium, or cobalt chrome) and the metal portion of the tibial component (typically also made of metal, such as stainless steel, titanium, or cobalt chrome) can be designed with a surface coating to facilitate the incorporation of the implant into the femur and tibia. The prosthesis may or may not be fixed in place using bone cement (PMMA (polymethylmethacrylate)). Representative examples of various components of knee replacements are described in U.S. Patent Nos. 5,413,604, 5,906,643, 6,019,794, and 7,922,771.

[0006] Figure 1 illustrates the types of total knee replacements and unicondylar (medial) knee replacements known in the art. Figure 2 illustrates the components and materials of a typical prosthesis (10), including a metal tibial plate (5) and tibial stem (2) (present in this figure, although some tibial plate components do not have stems), a polyethylene articular surface (7), cement (4) used to secure the various components in place, a patella "button" prosthesis (8), and a femoral knee component (9). Figure 3 illustrates another typical TKR, including a femoral component, tibial plate, and patella button. The patella button can be attached to the underlying bone (opposite the stemmed tibial plate) with screws and / or cement.

[0007] Unfortunately, the insertion of a full knee can lead to various complications during surgery, in the postoperative period, and over time. For example, the surgeon may want to ensure the correct anatomical alignment of the prosthesis and / or any movement between the prosthesis and the surrounding bone during surgery so that they can adjust during the procedure. After surgery, the patient may experience irritation and pain with the slightest movement, and may experience partial (subluxation) or complete dislocation of any of the components of the knee prosthesis. Over time, wear may progress between the femoral and tibial surfaces, causing the knee to function less well. Depending on the type of material used for the tibial and femoral surfaces, particulate debris may be generated during long-term wear, which may lead to peri-implant inflammation and bone erosion. A common associated complication occurs when, after some time (e.g., 8-12 years), bone loss (due to a process known as osteolysis) occurs in the tissues around the implant, causing the prosthesis to loosen and eventually fail. Both of the acute and chronic complications mentioned above can reduce the knee's ability to function, making movement and walking more difficult, and causing pain and inflammation for the patient.

[0008] As mentioned above, one of the most common serious complications of TKR is erosion of the bone around the implant (osteolysis). This can be caused by material debris (metal, ceramic and / or polyurethane chips) generated by friction, which can lead to inflammation and bone loss. Other potential causes of inflammation and osteolysis include vibration and migration of the implant, improper patient use / activity, improper alignment (e.g., improper patellar tracking), asymptomatic dislocation (subluxation) of the tibiofemoral and patellofemoral joints, mechanical wear, material destruction or fracture, loosening of the bone-cement bond, lack of biocompatibility of the implant material with the surrounding bone, metal allergy, and lack of biocompatibility of the bone cement with the surrounding bone. Early detection of these changes and the ability to take corrective or preventive measures would be of great value in the management of TKR patients. Other complications that may benefit from early detection and intervention include infection, fracture, implant microfracture, neuropathy, deep vein thrombosis, reduced motion, and instability.

[0009] Currently, in-hospital monitoring of post-operative knee replacement patients is performed by individual consultation by hospital staff and the medical team, physical examination of the patient, medical monitoring (e.g. vital signs), assessment of knee range of motion (ROM), physical therapy (including early mobilization and activity), and imaging and blood tests as needed. Once the patient is discharged from the hospital, the performance of the prosthesis and the patient's satisfaction are checked at regular visits. These checks include a detailed medical history, physical examination, and additional imaging and diagnostic tests to monitor the patient's progress and identify any possible complications. During the consultation, the surgeon will typically assess the knee's range of motion, determine whether certain movements or activities cause pain, and ask the patient questions regarding activity level, daily function, pain management, and rehabilitation progress.

[0010] Unfortunately, the majority of a patient's recovery time occurs between visits in the hospital and / or clinic. Thus, it can be very difficult to accurately measure and observe the full range of motion (ROM may vary depending on pain management, the level of anti-inflammatory drug therapy, time of day, recent activity, and / or how the patient feels at the time of the examination) from the date of surgery until full recovery, "real-life" prosthetic performance, the patient's activity level, exercise tolerance, and the effectiveness of rehabilitation efforts (physical therapy, medication, etc.). For most of this information, physicians rely on patient self-report or third-party observation to understand post-operative treatment effects, recovery, and rehabilitation progress. This is often further complicated when patients do not know what to expect, do not know what a "normal / expected" post-operative recovery should be, are non-compliant, or have difficulty communicating their symptoms. Furthermore, being able to identify and track complications (in or out of the hospital) before they become symptomatic, i.e. before they develop between visits, or complications that are difficult for patients (and / or physicians) to detect, would provide additional information that is useful for the management of TKR and partial knee replacement patients. Currently, in all cases, neither physicians nor patients have access to the kind of "real-time," continuous, objective prosthetic performance measurements they would like to have.

[0011] The present invention discloses novel total and partial knee replacement components, methods of constructing and monitoring these novel knee replacement components that overcome many of the problems of conventional knee replacements, and further provides other related advantages. Summary of the Invention

[0012] Briefly, total and partial knee prostheses have a number of sensors that monitor the integrity and effectiveness of the prosthesis within the patient. The sensors can be located on the exterior surface of the prosthesis, on the interior surface of the prosthesis, within the prosthesis material itself (stainless steel, titanium, cobalt chrome, polyurethane, low molecular weight polyurethane, ceramic, etc.), between various components including the prosthesis, the screws and / or fixation devices (if present) used to secure the prosthesis in place, within the bone cement (e.g., PMMA or a blend of PMMA and MMA copolymers) (if present) used to secure it to the knee, and / or within the tissue surrounding the prosthesis. In certain embodiments, the sensors are of the passive type and therefore do not require their own power source.

[0013] In one aspect of the invention, an assembly is provided for positioning and arranging within a patient an implant including a total or partial knee prosthesis; and one or more sensors located on, in, or around the prosthesis and / or within bone cement and / or bone screws or fasteners used to attach the prosthesis. In another aspect of the invention, a medical device is provided including at least one of a tibial component, a patellar prosthesis, or a femoral component, and one or more sensors. For clarity, the one or more sensors may be intentionally placed in specific locations on the knee prosthesis, medical device, and / or bone screws or fasteners, and / or may be randomly distributed throughout, on, and within the knee prosthesis, medical device, bone screws or fasteners, and bone cement. Thus, the use of the terms or phrases "located," "found," or "used" should not be construed as requiring specific placement, unless a specific placement is required.

[0014] In various embodiments, the sensors can be located on the exterior surface of the prosthesis, the interior surface of the prosthesis, within the material used to construct the prosthesis, between the various components that make up the prosthesis, the screws, and / or the fixation devices (if present) used to secure the prosthesis in place, on or in the bone cement used to secure the prosthesis, on or in the tissues surrounding the prosthesis (usually bone or bone marrow, but also muscle, ligaments, tendons, capsule, and / or synovial portions), or any combination thereof. Representative examples of sensors suitable for use in the present invention include accelerometers (acceleration, tilt, vibration, shock, and rotation sensors), pressure sensors, contact sensors, position sensors, chemical microsensors, tissue metabolism sensors, mechanical stress sensors, and temperature sensors. In particularly preferred embodiments, the sensors are wireless sensors or sensors connected to a wireless microprocessor.

[0015] In further embodiments, multiple of the aforementioned sensors are positioned on, within, or around the prosthetic knee (in the bone cement, bone screws, or tissue), and in preferred embodiments, the prosthetic knee can include two or more types of sensors (e.g., one or more of acceleration sensors, tilt sensors, vibration sensors, impact sensors, rotational sensors, pressure sensors, contact sensors, position sensors, chemical microsensors, tissue metabolism sensors, and mechanical stress sensors, or any combination thereof).

[0016] According to various embodiments, sensors are placed at various locations on the knee prosthesis to monitor operation, motion, medical images (both the prosthesis and surrounding tissues), function, wear, performance, potential side effects, the patient's medical condition, the prosthetic knee's medical condition, and the medical condition of the interface between the prosthesis and the patient's natural tissues. Patient activity, patient function, prosthesis activity, prosthesis function, prosthesis performance, prosthesis joint alignment, patella tracking, prosthesis forces and joint forces and mechanical stresses, prosthesis and surrounding tissue anatomy (imaging), prosthesis mechanical and physical integrity, patella tracking, and potential side effects can be monitored in situ in real time. In addition, information is available about many aspects of the prosthesis and its interaction with the patient's body tissues, including clinically significant measurements that are currently not feasible through physical examination, medical images, and diagnostic medical studies.

[0017] According to one embodiment, the sensor provides assessment data regarding the range of motion (ROM) of the knee. Currently, ROM is typically measured clinically by a physician passively moving the knee joint through a full range of motion during a physical examination and recording the results (degree of flexion, extension, anterior / posterior stability, and medial / lateral stability, see, for example, FIG. 4). Motion sensors and accelerometers can be used to accurately determine the full ROM of a prosthetic knee joint during a physical examination and during normal daily activities between appointments. Similarly, motion sensors and accelerometers can be used to accurately measure anterior / posterior instability or medial / lateral instability of a prosthetic knee joint (including complete, partial, or asymptomatic dislocation) during a physical examination and during normal daily activities between appointments. In addition, motion sensors and accelerometers can be used to accurately measure improper patellar tracking and / or patellar instability (including complete, partial, or asymptomatic dislocation) during a physical examination and during normal daily activities between appointments.

[0018] According to one embodiment, contact sensors are provided between the prosthesis and the surrounding bone, between the screws and / or fasteners (if present) and the surrounding bone, between the prosthesis and the surrounding bone cement (if present), and / or between the bone cement (if present) and the surrounding bone to measure bone erosion and loosening around the implant. In another embodiment, vibration sensors are provided to detect vibrations between the prosthesis and the surrounding bone, between the screws and / or fasteners (if present) and the surrounding bone, between the prosthesis and the surrounding bone cement, and between the bone cement and the surrounding bone as early indicators of movement and loosening. In another embodiment, strain gauges are provided to detect strains between the prosthesis and the surrounding bone, between the screws and / or fasteners (if present) and the surrounding bone, between the prosthesis and the surrounding bone cement, between the bone cement and the surrounding bone, as well as strains occurring in various parts of the prosthesis. A sudden increase in strain may indicate that the prosthesis is overstressed, which may increase damage to the body. For example, a gradual, long-term decrease in strain may result in bone resorption around the implant, potentially leading to loosening of the prosthesis or fracture of the peri-prosthetic bone, whereas a gradual, long-term increase in strain may lead to microfractures of the prosthesis material itself.

[0019] According to other embodiments, accelerometers are provided to detect vibration, shock, tilt, and rotation. According to other embodiments, sensors that measure surface wear, such as contact or pressure sensors, can be embedded at various depths within the femoral, tibial, and / or patellar articular surfaces to monitor erosion of the articular surfaces. In other embodiments, position sensors and other types of sensors are provided that indicate range of motion and monitor partial (or complete) femoro-tibial joint dislocation or subluxation, improper patellar tracking and / or subluxation of the patello-femoral joint over time and in real-life use, or movement between interconnected components of the prosthesis (and fasteners) itself.

[0020] In further embodiments, a (full or partial) prosthetic knee can include sensors at specific locations and densities. For example, a prosthetic knee can have sensors (e.g., acceleration sensors, tilt sensors, vibration sensors, impact sensors, rotation sensors, pressure sensors, contact sensors, position sensors, chemical microsensors, tissue metabolism sensors, and mechanical stress sensors, or any combination thereof) at a density of 1, 2, 3, 4, 5, 6, 7, 8, 9, or more than 10 sensors per square centimeter of device. In other embodiments, a (full or partial) prosthetic knee can have sensors (e.g., acceleration sensors, tilt sensors, vibration sensors, impact sensors, rotation sensors, pressure sensors, contact sensors, position sensors, chemical microsensors, tissue metabolism sensors, and mechanical stress sensors, or any combination thereof) at a density of 1, 2, 3, 4, 5, 6, 7, 8, 9, or more than 10 sensors per cubic centimeter of device. In related embodiments, sensors (e.g., acceleration sensors, tilt sensors, vibration sensors, shock sensors, rotation sensors, pressure sensors, contact sensors, position sensors, chemical microsensors, tissue metabolism sensors, and mechanical stress sensors) can be placed at specific locations on, within, or around the knee prosthesis, such as the femoral component (medial, lateral, or both), the tibial plate, the tibial stem (if present), the tibial lining, the patella lining of the prosthesis, the mating parts of the device (e.g., the connection between the tibial cup and the tibial lining), the screws, and / or fixation devices (if present) used to secure the prosthesis in place, and around the knee prosthesis, such as on or in the bone cement used to secure the knee prosthesis, on or in the tissues surrounding the knee prosthesis (usually bone or bone marrow, but also muscles, ligaments, tendons, capsule, and / or synovial parts).

[0021] In certain embodiments of the invention, a total or partial knee prosthesis is given a specific unique identification number, and in further embodiments, each sensor on, in, or around the knee prosthesis has a specific unique or group identification number (e.g., an identification number that identifies the sensor as an acceleration sensor, tilt sensor, vibration sensor, impact sensor, rotation sensor, pressure sensor, contact sensor, position sensor, chemical microsensor, tissue metabolism sensor, or mechanical stress sensor). In still further embodiments, the specific unique or group identification number is specifically associated with a location on, in, or around the knee prosthesis.

[0022] In another aspect of the invention, a method of monitoring an inserted total or partial knee prosthesis is provided, the method comprising the steps of transmitting a wireless electrical signal from a location outside the body to a location inside the body, receiving the signal with a sensor located on, in or around the internally located prosthetic knee, powering the sensor using the received signal, sensing data with the sensor, and outputting the sensed data from the sensor to a receiving unit located outside the body.

[0023] In another aspect of the invention, there is provided a method of imaging a knee replacement component or medical device as described herein. The method includes the steps of (a) detecting the location of one or more sensors on the knee replacement component or medical device, and (b) visually displaying the location of the one or more sensors to generate an image of the knee replacement component or medical device. In various embodiments, the detecting step can be performed over time, and thus the visual display can show positional movement over time. In certain embodiments, the displayed image is a two-dimensional image or a three-dimensional image. In a preferred embodiment, various images may be collected and displayed over time (e.g., as a movie or "movie-like" images).

[0024] The imaging techniques presented herein can be used for a wide variety of purposes. For example, in one aspect, imaging techniques can be used during a surgical procedure to ensure proper placement and function of a knee replacement component or medical device. In other embodiments, imaging techniques can be used post-operatively to inspect a knee replacement component or medical device and / or compare operation and / or performance of the device over time.

[0025] The integrity of the partial or total knee prosthesis can be wirelessly interrogated and the results reported periodically. This allows the patient's health to be checked periodically or at the patient's and / or doctor's convenience. Furthermore, subjective / symptom data can be compared with objective / sensor data by wirelessly interrogating the prosthesis when the patient signals to do so (via an external signal / actuator) as part of an "event record", i.e., by signaling / activating the device to read simultaneously when the patient experiences a particular event (e.g., pain, injury, instability, etc.). Matching of event record data with sensor data can be used as part of an effort to better understand the root cause or specific trigger of a particular symptom in a patient. Thus, in various embodiments of the present invention, a method is provided for detecting and / or recording events in a subject having a total or partial knee replacement member as described herein. The method includes a step of interrogating at a desired time. Thus, in one aspect of the present invention, a method is provided for detecting and / or recording events in a subject having a knee replacement member or medical device as described herein. The method includes interrogating activity of one or more sensors within the knee replacement component or medical device at desired times and recording said activity. In various embodiments, this may be performed by the subject and / or a medical professional. In related embodiments, the recording step may be performed by one or more wired devices or wireless devices that can be carried or worn (e.g., a mobile phone, a watch, a wristband, and / or glasses). In further embodiments, the worn devices (e.g., a mobile phone, a watch, a wristband, and / or glasses) have sufficient processing power and memory to further collect and analyze data.

[0026] In further embodiments, the sensors each have a signal receiving circuit and a signal output circuit. The signal receiving circuit receives an interrogation signal having both power and data collection request components. Using power from the interrogation signal, the sensor powers up the necessary circuitry to manage the sensing, perform the sensing, and then output the data to the interrogation module. The interrogation module operates under the control of a control unit that includes appropriate I / O circuitry, memory, a controller in the form of a microprocessor, and other circuitry for driving the interrogation module. In yet other embodiments, the sensor (e.g., an acceleration sensor, tilt sensor, vibration sensor, shock sensor, rotation sensor, pressure sensor, contact sensor, position sensor, chemical microsensor, tissue metabolism sensor, or mechanical stress sensor) is configured to be easily incorporated into the knee prosthesis or otherwise mechanically attached to the knee prosthesis (e.g., by an aperture or other attachment that allows the sensor to be permanently attached to the knee prosthesis) and / or easily incorporated into the bone cement or tissue surrounding the knee prosthesis.

[0027] In yet another aspect of the method of the present invention, an apparatus is provided that is suitable for transmitting a wireless electrical signal from a location outside the body to a location inside the body; receiving the signal with one of the aforementioned sensors located on, in, or around the internally located prosthetic knee joint; powering the sensor using the received signal; sensing data with the sensor; and outputting the sensed data from the sensor to a receiving unit located outside the body. In certain embodiments, the receiving unit can provide an analysis of the signal provided by the sensor.

[0028] Data collected by the sensors can be stored in memory located on the femoral component, tibial plate, and / or tibial stem. During a consultation, the data can be downloaded via the wireless sensors, providing the physician with representative data of the real-time performance of the prosthesis.

[0029] Advantages gained include more accurate monitoring of the prosthesis and enabling accurate in situ medical reporting of data that may benefit patient health. Details of one or more embodiments are set forth in the following description. Other features, objects, and advantages will become apparent from the description, drawings, and claims. Additionally, all patents and patent applications mentioned herein are hereby incorporated by reference in their entirety. [Brief description of the drawings]

[0030] [Figure 1] 1A-1D show total and unicompartmental knee replacement components. [Diagram 2] FIG. 1 is an exploded view showing the various components of a total knee replacement. [Diagram 3] 13A-13C illustrate components of another total knee replacement. [Figure 4] FIG. 1 shows representative range of motion (ROM) for subjects undergoing total knee arthroplasty. [Diagram 5] FIG. 1 illustrates a total knee replacement (TKR) having various contact sensors. [Figure 6] FIG. 1 illustrates a total knee replacement component having various strain gauges. [Figure 7] FIG. 1 illustrates a total knee replacement component having various accelerometers. [Figure 8] FIG. 1 illustrates a total knee replacement component having various position sensors. [Figure 9] FIG. 1 illustrates a total knee replacement component having sensors positioned to detect joint wear. [Figure 10] FIG. 1 illustrates an embodiment of an information and communications technology system arranged to process sensor data. [Figure 11] FIG. 2 is a block diagram of a sensor, an interrogation module, and a control unit according to one embodiment of the present invention. [Figure 12]FIG. 1 is a schematic diagram showing one or more sensors located on a total knee replacement component within a subject's body being probed for data and outputting data in accordance with one embodiment of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0031]

[0042] Briefly, the present invention provides a variety of total knee replacement components that can be utilized to monitor the integrity and effectiveness of the device. However, prior to describing the invention, definitions of certain terms that will be used hereinafter are first provided to aid in an understanding of the invention.

[0032]

[0043] As used herein, the term "knee replacement" or "prosthesis" may take many different forms and may relate to replacing all (total knee replacement) or part (partial knee replacement) of a patient's knee joint with synthetic material. In a total knee replacement (TKR), both the femoral and tibial sides are replaced. In a partial knee replacement or unicompartmental knee replacement, only one or two parts of the knee joint are replaced (the tibial or femoral surfaces, or the medial, lateral, or patellar compartments).

[0033]

[0044] The various components of a TKR can typically include a femoral implant, a patellar implant, and a tibial implant (which can consist of a tibial plate (with or without a stem) and a tibial liner). Currently, the various components can be manufactured from a wide variety of materials, such as polyethylene, ultra-high molecular weight polyethylene, ceramics, surgical stainless steel, cobalt chrome, titanium, and various ceramic materials. In some devices, the femoral implant (typically made of a metal such as stainless steel, titanium, or cobalt chrome) can be designed with a bone surface coating to facilitate integration of the implant within the femur, and the tibial plate (and stem) can likewise have a surface coating to facilitate integration into the tibia. Representative examples of the various components of a total knee replacement are described in U.S. Patent Nos. 5,413,604, 5,906,643, 6,019,794, and 7,922,771.

[0034] (0045) "Bone cement" refers to a material that can be applied between a prosthetic device and the surrounding bone and hardens in place upon cooling (or otherwise activation). It is the substance used to secure one or more components of a prosthesis (the femoral surface of the prosthesis, the tibial plate / stem, the patella "button") to the appropriate bone tissue (femur, tibia, tibial medullary tissue, patella). In most cases, bone cement consists of PMMA (polymethylmethacrylate) or a blend of PMMA and MMA copolymers. However, bone screws and / or other metallic (or polymeric) fixation means can also be used to help secure the prosthetic components to the surrounding bone tissue.

[0035]

[0046] The present invention provides knee prostheses (which may include a full or partial implant), medical devices (e.g., portions of a knee implant, and / or components or materials useful in the process of implanting the device), or kits (e.g., knee prostheses, medical devices, and additional necessary materials such as bone cement and associated delivery devices), all of which include sensors, as described in more detail below. The knee prostheses, medical devices, and kits (including associated materials such as bone cement) provided herein are preferably sterile, non-pyrogenic, and / or suitable for use and / or implantation in the human body. However, in certain embodiments of the invention, the knee prostheses, medical devices, and / or kits can be manufactured in a non-sterile environment (or even for an individual subject) and sterilized at a later point in time.

[0036] (0047) A "sensor" can be utilized to measure one or more different aspects of the body, the prosthetic knee joint, medical device or kit inserted therein, and / or the integrity, impact, efficacy, or effect of the prosthetic knee joint, medical device or kit inserted therein. Representative examples of sensors suitable for use in the present invention include, for example, flow pressure sensors, contact sensors, position sensors, pulse pressure sensors, fluid (e.g., blood) volume sensors, fluid (e.g., blood) flow rate sensors, chemical sensors (e.g., for blood and / or other fluids), metabolic sensors (e.g., for blood and / or other fluids), accelerometers, mechanical stress sensors, and temperature sensors. In certain embodiments, the sensor can be a wireless sensor, or in other embodiments, a sensor connected to a wireless microprocessor. In further embodiments, one or more (including all) sensors can have a unique sensor identification number ("USI") that specifically identifies the sensor.

[0037]

[0048] A wide variety of sensors (also called Microelectromechanical Systems or "MEMS", or Nanoelectromechanical Systems or "NEMS", and BioMEMS or BioNEMS, generally see https: / / en.wikipedia.org / wiki / MEMS) can be used in the present invention. Representative patents and patent applications include U.S. Patent Nos. 7,383,071 and 8,634,928, and U.S. Patent Application Publication Nos. 2010 / 0285082 and 2013 / 0215979. Representative publications include "Introduction to BioMEMS", written by Albert Foch, CRC Press 2013; "From MEMS to Bio-MEMS and Bio-NEMS: Manufacturing Techniques and Applications", written by Marc J. Madou, CRC Press 2011; "Bio-MEMS: Science and Engineering Perspectives", written by Simona Badilescu, CRC Press 2011; "Fundamentals of "BioMEMS and Medical Microdevice", written 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; "Inertial MEMS: Principles and Practice", written by Volker Kempe, Cambridge University Press, 2011; Polla, DL, et al., "Microdevice in Medicine”, Ann.Rev.Biomed.Eng.2000,02:551-576;Yun, KS, 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; 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 which are incorporated herein by reference in their entireties.

[0038]

[0049] In various embodiments of the present invention, the sensors described herein may be placed in various locations and in various configurations, such as on the inside, interior, and / or exterior (or surface) of the knee prosthesis, medical device, or kit, and between the knee prosthesis, medical device, or kit and any device (e.g., delivery device or introduction device) that it comprises. As will be readily apparent from the disclosure provided herein, the sensors may be placed simultaneously in multiple locations (i.e., on the inside, interior, and exterior) of the knee prosthesis, medical device, or kit. In certain embodiments, the knee prosthesis, medical device, or kit, associated medical device (e.g., delivery device), or kit comprises sensors at a density of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 sensors per square centimeter. In another aspect, the knee prosthesis, medical device, or kit, associated medical device (e.g., delivery device), or kit comprises sensors at a density of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 sensors per cubic centimeter. In any of these embodiments, there can be less than 50, 75, 100, or 100 sensors per square centimeter or per cubic centimeter. In various embodiments, at least one or more sensors can be positioned randomly or at one or more specific locations within a catheter, medical device, or kit described herein.

[0039]

[0050] In various embodiments, the sensors may be positioned within a specific location and / or randomly anywhere on the knee prosthesis, medical device or kit, associated medical device (e.g., delivery device) or kit. Additionally, the sensors may be positioned in a specific shape (e.g., an X, as an oval, or concentric circle shape around the knee prosthesis, medical device or kit, associated medical device (e.g., delivery device) or kit).

[0040]

[0051] Exemplary embodiments of knee prosthesis, medical devices and kits In order to further understand the various aspects of the invention set forth herein, the following sections are set forth below: A. knee prostheses, medical devices and kits, and uses thereof; B. Use of knee prostheses, medical devices and kits to deliver therapeutic agents; C. Use of knee prostheses, medical devices or kits with sensors to measure implant deterioration or wear; D. Methods for monitoring infection in knee prostheses, medical devices and kits; E. Further uses of sensor-integrated knee prostheses, medical devices and kits in health care; F. Power generation by knee prostheses, medical devices and kits; G. Medical imaging and self-diagnosis, predictive analysis and predictive maintenance of assemblies including knee prostheses, medical devices and kits; H. Methods for monitoring assemblies including knee prostheses, medical devices and kits; I. Collection, transmission, analysis and distribution of data from assemblies including knee prostheses, medical devices and kits.

[0041] (0052) A. Artificial knee joints, medical devices and kits, and their uses Knee replacement surgery is performed when a patient's knee joint loses full function, resulting in disability, loss of motion or function, impaired ambulation, and / or ongoing joint pain or discomfort. Common causes of knee joint dysfunction leading to total or partial knee replacement include various forms of arthritis (such as rheumatoid arthritis or osteoarthritis, and trauma (e.g., previous knee ligament injury or cartilage / meniscus tear). In the majority of patients, surgery is successful in improving gait, restoring normal daily function, and relieving pain, resulting in it being a very common orthopedic treatment in Western countries.

[0042]

[0053] Figures 5, 6, 7, 8, and 9 show several prostheses 10 in the form of total knee prostheses having one or more sensors located in or on the prosthesis for sensitively and over time monitoring in situ real-time operation of the prosthesis, the patient's level of function and activity, and prosthesis performance. A variety of these sensors will now be described according to various embodiments.

[0043]

[0054] In one embodiment shown in Figure 5, one or more contact sensors 22 are provided throughout the implant, including contact sensors 22A distributed on and within the interface between the artificial femoral condyle and the bone, contact sensors 22B distributed on and within the interface between the tibia and the metal plate (and stem, if present), and contact sensors 22C distributed on and within the interface between the artificial patella prosthesis (patella "button") and the patella. In some embodiments, the contact sensors are on the prosthesis components themselves (tibia, femur, and patella portions), while in other embodiments, the contact sensors are included on / in the bone cement (if present) used to secure the prosthesis to the surrounding bone, and in still other embodiments, the contact sensors are included on / in both the prosthesis components and the bone cement (PMMA).

[0044] (0055) In various embodiments, these sensors may be arranged in a wide variety of shapes on the prosthetic components depending on their contact location with the surrounding bones (femur, tibia, and / or patella) and / or surrounding bone cement (if present). For example, they may be arranged in X, oval, or concentric circle shapes around the various components, or in various other shapes, to collect precise data regarding the physical contact between the tibial component and the tibia and / or surrounding bone cement (if present), between the femoral component and the femur and / or surrounding bone cement (if present), and between the patella component and the patella and / or surrounding bone cement (if present). Contact sensors may also be distributed / located within the bone cement (if present), to collect precise data regarding the physical contact between the bone cement and the components of the prosthesis (femur, tibia, and patella) and / or between the bone cement and the bones (femur, tibia, patella) themselves.

[0045]

[0056] In various embodiments of the invention, contact sensors are disposed on the tibial, femoral, and / or patellar components of a knee prosthesis and / or in the bone cement securing the prosthetic components to the surrounding bone at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 sensors per square centimeter or cubic centimeter of the prosthetic device component and / or per cubic centimeter of bone cement.

[0046]

[0057] In another aspect of the invention, there is provided a method of imaging a knee prosthesis or medical device as described herein. The method includes the steps of (a) detecting the location of one or more sensors on the knee prosthesis or medical device, and (b) visually displaying the location of the one or more sensors to generate an image of the knee prosthesis or medical device. In various embodiments, the detecting step can occur over time, such that the visual display can show positional movement over time. In certain preferred embodiments, the image displayed is a three-dimensional image.

[0047]

[0058] The imaging techniques described herein can be used for a wide variety of purposes. For example, in one aspect, imaging techniques can be used during a surgical procedure to ensure proper placement and function of a knee replacement or medical device. In other embodiments, imaging techniques can be used post-operatively to inspect knee replacement components or medical devices and / or to compare device operation and / or performance over time.

[0048] (0059) In one embodiment, the contact sensors 22 (22A, 22B, 22C) can detect loosening of the prosthesis 10 and bonding with the surrounding cement (if present) and / or bone. For example, a contact sensor (22B) located on / in the tibial component and / or on / in the bone cement surrounding the tibial component can detect loosening of the tibial component inside the tibia. This sensor can accurately detect during surgery and alert the surgeon that some intraoperative adjustment is required. Progressive loosening of the tibial component inside the tibia over time (relative to the post-operative level) is a common complication when bone loss occurs (e.g., due to a process known as osteolysis). This can also be detected with a contact sensor on / in the tibial component and / or on / in the surrounding bone cement. Additionally, a contact sensor located between portions of the tibial component (e.g., between the tibial plate and the tibial liner) can detect abnormal movement, loosening, or wear between the component portions. These sensors can also be "matched" (i.e., "paired" between adjacent components) to allow for precise attachment during (and after) surgical placement.

[0049] (0060) Thus, in the embodiment of FIG. 5, various contact sensors are provided to monitor contact between the tibia and tibial components, between the femur and femoral components, between the patella and patella components, between the complimentary parts of the individual prosthetic components, and between the various articular surfaces (medial and lateral tibiofemoral joints; patellofemoral joints) present in a multi-compartment or single compartment knee prosthesis. In particular, complete or partial dislocation (subluxation) of the artificial femoral articular surface from the natural or artificial tibial articular surface (medial, lateral, or both) of the knee prosthesis is a common complication of total knee replacement surgery and often occurs soon after surgery (especially during the post-operative recovery period, when the surrounding muscles and ligaments are recovering from surgery). Contact sensors on the articular surface of the femoral component and / or the articular surface of the tibial component can alert the patient and medical provider when a joint dislocation or subluxation occurs. This is particularly useful for detecting asymptomatic partial or incomplete dislocations (subluxations) of the knee joint, which may not be readily apparent to patients or physicians. This is of paramount concern in early mobilization and post-operative rehabilitation efforts. In addition, contact sensors on the various knee joint components can determine whether the joint is functioning and aligning (tracking) correctly during motion and activity. This is especially true with respect to patellar kinematics. Accurate patellar tracking is difficult to accurately measure clinically, so accurate measurement of both intraoperative and postoperative patellar tracking would be beneficial.

[0050]

[0061] In another embodiment shown in Figure 6, one or more strain gauges (or sensors) 26 are provided throughout the implant, including strain gauges 26A distributed on and within the artificial femoral condyle-bone interface, strain gauges 26B distributed on and within the tibia-metal plate (and stem, if present) interface, and strain gauges 26C distributed on and within the artificial patella prosthesis (patella "button")-patella interface. In some embodiments, the strain gauges are on the prosthesis components themselves (tibia, femur, and patella portions), while in other embodiments, the strain gauges are included on / in the bone cement (if present) used to secure the prosthesis to the surrounding bone, and in other embodiments, the strain gauges are included on / in both the prosthesis components and the bone cement (PMMA).

[0051]

[0062] In various embodiments, these strain gauges may be arranged in a wide variety of shapes on the prosthetic components depending on their contact location with the surrounding bone (femur, tibia, and / or patella) and / or surrounding bone cement (if present), for example in X, oval or concentric circle shapes around the various components, or in various other shapes, to collect accurate data regarding the physical strains occurring in the prosthetic components, the surrounding bone cement (if present), and the surrounding bone (femur, tibia, patella) tissue.

[0052]

[0063] In various embodiments of the invention, strain sensors are positioned on the tibial component, femoral component, patellar prosthesis, and / or in the bone cement at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 sensors per square centimeter of the prosthetic component or per cubic centimeter of PMMA bone cement.

[0053]

[0064] The strain gauges 26 provide different data points than the contact sensors 22. The contact sensors 22 only identify whether there is current contact between adjacent structures, and therefore are sufficient to indicate whether there is adjacent contact between two surfaces. However, they do not indicate the physical strains present on either the prosthesis surface or the surrounding bone. In contrast, the output data of the strain sensors 26 indicates the mechanical strain forces across the entire implant, which, if inappropriate, may be a precursor to future loosening or prosthesis failure. Additionally, the strain gauges 26 may be of a type that indicates strains occurring between two surfaces, such as between the tibial side and bone, between the femoral side and bone, between the patella side and bone, between the prosthesis components (tibia, femur, and patella) and bone cement, or between the tibial component, the femoral component, and the patella component, respectively.

[0054] (0065) As shown in FIG. 6, strain gauges 26 can be placed at various locations on the tibial component to detect strain occurring between the tibial prosthesis and the surrounding tibia (and / or bone cement, if present). Many tibial prostheses have a stem that extends into the medullary canal of the tibia to enhance fixation and stability. A decrease in strain in the tibial prosthesis and / or tibial bone cement may indicate a condition in which bone resorption (loss) may occur in all or part of the tibial canal. Bone resorption may lead to prosthesis loosening or tibia fracture (conversely, an increase in strain would favor bone growth in that area). Thus, the strain sensor indicates the strain present in the tibial shaft and can measure the most important mechanical strain forces across the implant. This strain force, if malaligned or improper, is likely to lead to loosening or prosthesis failure. An increase in strain may also indicate bone hypertrophy (growth), which may be a source of pain. Similar dynamics exist at the interfaces between the femoral and patella prosthetic components (and / or bone cement) and between the femur and the patella. The strain gauges 26 of the present invention can be used for monitoring for these purposes as well. "Real life" strain information is beneficial not only to physicians and patients who could use the data to gauge the effect (good or bad) of various activities on the health of the prosthesis, but also to manufacturers who could use this to design better prostheses.

[0055]

[0066] In another embodiment shown in Figure 7, one or more accelerometers 27 are provided throughout the implant, including accelerometers 27A distributed on and within the artificial femoral condyles, accelerometers 26B distributed on and within the tibial plate (and stem, if present) and tibial liner, and accelerometers 27C distributed on and within the artificial patella prosthesis (patella "button"). In some embodiments, the accelerometers are on / in the prosthetic components themselves (tibia, femur, and patella portions), while in other embodiments, the accelerometers are included on / in the bone cement (if present) used to secure the prosthesis to the surrounding bone, and in other embodiments, the accelerometers are included on / in both the prosthetic components and the bone cement (PMMA).

[0056]

[0067] In various embodiments, the accelerometers may be positioned in / on the prosthetic components in a variety of different shapes depending on their contact location relative to the surrounding bone (femur, tibia, and / or patella), the surrounding bone cement (if present), the articular interfaces between the different prosthetic components (tibiofemoral joint and patellofemoral joint), and / or between the sub-portions of the components (e.g., between the tibial plate and tibial liner). For example, they may be positioned in an X, oval or concentric circle shape, or in various other shapes around or within the various components, thereby collecting accurate data on what is happening to the prosthetic components, the surrounding bone cement (if present), and the surrounding bone (femur, tibia, patella) tissue.

[0057]

[0068] In various embodiments of the invention, accelerometers are placed on / in the tibial component, femoral component, patellar prosthesis, and / or in the bone cement at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 per square centimeter or cubic centimeter of device and / or bone cement.

[0058]

[0069] Accelerometers provide the benefit of being able to detect acceleration, vibration, shock, tilt, and rotation of various components. The accelerometers allow the performance of the prosthesis 10 to be measured over time and under a variety of conditions.

[0059] (0070) During knee replacement surgery, the prosthesis can be moved through a full range of motion and stability test to evaluate the function and mobility of the prosthesis before the surgery is completed. The accelerometer 27 can then provide the surgeon with accurate, numerical, and quantitative range of motion data. This data can be compared to expected values ​​to evaluate the effectiveness of the implantation procedure or used as a baseline value for comparison with functional values ​​obtained after surgery. Any abnormalities in vibration (indicating insufficient fixation of the prosthesis to the surrounding bone), tilt (indicating improper tracking and / or alignment of the tibiofemoral and patellofemoral joints), rotation (indicating dislocation or subluxation), and / or range of motion can then be addressed and adjusted intraoperatively by the surgeon. Soon after the knee replacement, the leg can be moved postoperatively, first passively and then actively. Soon after recovery from the procedure, the patient can gradually begin to bear weight on the joint. The accelerometer 27 can measure the motion and tracking of the knee joint during movements such as walking, where the leg swings forward, hits the ground, stands firm, leaves the ground, and propels the body forward. In addition, the accelerometer can measure the impact of the foot hitting the ground, as well as the forces transferred from the tibia to the knee joint, and the effects of vibration, shock, or rotation occurring at various locations of the prosthesis 10. As the patient's range of motion continues to improve after surgery, accelerations can be observed occurring at various locations within the artificial knee joint. As the patient recovers from surgery, it is expected that activity levels will gradually improve, with improved and increased gait, faster (and smoother) steps, and longer strides. The effects of exercises and various activities can be monitored with the various accelerometers 27 and compared to the patient's subjective experience to determine which life activities improve (or hinder) post-operative recovery and rehabilitation.

[0060] 8, one or more position sensors 28 are provided throughout the implant, including position sensors 28A distributed on and within the artificial femoral condyles, position sensors 26B distributed on and within the tibial plate (and stem, if present) and tibial liner, and position sensors 27C distributed on and within the artificial patellar prosthesis (patellar "button"). In some embodiments, the position sensors are on / in the prosthetic components themselves (tibia, femur, and patellar portions), while in other embodiments, position sensors are included on / in the bone cement (if present) used to secure the prosthesis to the surrounding bone, and in other embodiments, position sensors are included on / in both the prosthetic components and the bone cement (PMMA).

[0061]

[0072] In various embodiments, the position sensors may be positioned in / on the prosthetic components in a wide variety of shapes depending on their contact location relative to the surrounding bone (femur, tibia, and / or patella), the surrounding bone cement (if present), the articular interfaces between the different prosthetic components (tibiofemoral joint and patellofemoral joint), and / or between sub-portions of the components (e.g., between the tibial plate and tibial liner). For example, they may be positioned in X, oval, or concentric circle shapes, or in various other shapes around or within the various components, thereby collecting accurate data about what is happening to the prosthetic components, the surrounding bone cement (if present), and (by extension) the surrounding bone (femur, tibia, patella) tissue.

[0062]

[0073] In various embodiments of the invention, position sensors 28 are positioned on the tibial component, femoral component, patellar prosthesis, and / or in the bone cement at a density of 1, 2, 3, 4, 5, 6, 7, 8, 9, or greater than 10 sensors per square centimeter or cubic centimeter of device and / or bone cement.

[0063]

[0074] The position sensor 28 described herein can be utilized to provide accurate position data (intra-operative and post-operative) including flexion and extension measurements to improve the accuracy of physical examinations by providing three-dimensional data of the implant, detect complete and partial dislocation (subluxation) of the tibiofemoral (knee) joint and / or patellofemoral joint, and determine proper tracking of the knee joint and patella.

[0064]

[0075] In another embodiment shown in FIG. 9, one or more contact or pressure sensors 22 are provided throughout the implant, including contact or pressure sensors 22A distributed (at various depths) on and within the femoral condyle articular surface, contact or pressure sensors 22B distributed (at various depths) on and within the tibial joint liner, and contact or pressure sensors 27C distributed on and within the patella joint prosthesis (patella "button").

[0065]

[0076] These sensors can also be used to detect progressive erosion of the various articular surfaces. Sensors 22 can be placed at graded depths into the articular surface material of the tibia, femur, and patella. These sensors can be activated upon exposure (or wear of the covering surface) to indicate the extent and depth of surface loss.

[0066]

[0077] Such sensors can be used to estimate the remaining useful life of an implant and to compare the performance and designs of different materials and implants.

[0067] (0078) B. Use of Prosthetic Knees, Medical Devices, and Kits for Delivering Therapeutic Agents As mentioned above, the present invention also provides knee prostheses, medical devices, and kits that include one or more sensors and can be utilized to release a therapeutic agent (e.g., a drug) to a desired location within the body. For example, an anti-restenosis agent (e.g., paclitaxel, sirolimus, or analogs or agonists thereof) can be administered by the knee prosthesis, medical device, or kit. In a preferred embodiment, one or more sensors (e.g., pressure sensors, contact sensors, and / or position sensors) can be utilized to determine proper placement of the desired drug and the amount of drug released at the desired location.

[0068]

[0079] In other embodiments of the invention, a wide variety of therapeutic agents can also be delivered (e.g., to prevent or treat infections or to treat other medical conditions). These therapeutic agents include, for example, anthracyclines (e.g., gentamicin, tobramycin, doxorubicin, and mitoxantrone); fluoropyrimidines (e.g., 5-FU); folate antagonists (e.g., methotrexate); podophyllotoxins (e.g., etoposide); camptothecin; hydroxyurea, and platinum complexes (e.g., cisplatin) (see, e.g., U.S. Pat. No. 8,372,420, the disclosure of which is incorporated herein by reference in its entirety). Other therapeutic agents include beta-lactam antibiotics (e.g., penicillins, cephalosporins, carbapenems, and carbapenems); aminoglycosides (e.g., sulfonamides, quinolones, and oxazolidinones); glycopeptides (e.g., vancomycin); lincosamides (e.g., clindamycin); lipopeptides; macrolides (e.g., azithromycin); monobactams; nitrofurans; polypeptides (e.g., bacitracin), and tetracyclines.

[0069] (0080) C. Use of knee replacement prostheses, medical devices or sensors to measure deterioration or wear of implants As described above, in various aspects of the present invention, knee prostheses, medical devices, and kits can detect and monitor deterioration of the implant. For example, in one embodiment of the present invention, a method for deterioration of a knee prosthesis, medical device, or kit is provided. The method includes a) providing a subject with a knee prosthesis, medical device, or kit having a sensor as described herein, and b) determining deterioration of the knee prosthesis, medical device, or kit by detecting a change in the sensor. In various embodiments, the sensor can detect one or more physiological and / or positional parameters. In another embodiment, the sensor can detect contact, flow, pressure, and / or temperature. In yet another embodiment, the sensor can detect a position within the subject's body.

[0070]

[0081] As the knee prosthesis deteriorates or becomes damaged, the sensor can detect changes to determine the damage and / or deterioration. For example, a sensor previously embedded within the polymeric portion of the device will be exposed to fluid forces and pressures that were not previously present upon deterioration. As the sensor wears down, it will migrate into the synovial cavity (i.e., away from the original insertion location). Thus, in preferred embodiments of the present invention, deterioration can be detected over an extended period of time.

[0071]

[0082] D. Methods for Monitoring Infection in Prosthetic Knees, Medical Devices, and Kits In other embodiments, prosthetic knees, medical devices, and kits are provided that include one or more temperature and / or metabolic sensors. Such prosthetic knees, medical devices, or kits can be used to measure the temperature of the prosthetic knee, medical device, or kit, as well as the temperature in local tissue adjacent to the prosthetic knee, medical device, or kit. Methods are also provided for determining and / or informing (e.g., a patient and / or a health care provider) of impending infection by monitoring temperature changes over time.

[0072] (0083) In certain embodiments of the present invention, metabolic and physical sensors may be placed on or within various components of the total knee prosthesis, partial knee prosthesis, medical device or kit to monitor rare but potentially life-threatening complications of the knee prosthesis, medical device or kit. In some patients, the knee prosthesis, medical device or kit and surrounding tissue may become infected. This is usually due to bacteria that colonize the patient's own skin contaminating the surgical field (most often Staphylococcus aureus or Staphylococcus epidermidis). Temperature sensors (detecting an increase in temperature), pH sensors (detecting a decrease in pH), and other metabolic sensors may be used to indicate the presence of an infection on or around the implant. For example, a temperature sensor may be placed within one or more components of the knee prosthesis, medical device or kit to allow for early detection of an infection, allowing preemptive treatment with antibiotics and surgical drainage, which may eliminate the need for surgical removal of the knee prosthesis, medical device or kit.

[0073]

[0084] Thus, in one embodiment of the present invention, a method for determining an infection associated with a knee replacement, medical device, or kit is provided. The method includes the steps of: a) providing a subject with a knee replacement, medical device, or kit as described herein, the knee replacement, medical device, or kit comprising at least one temperature and / or metabolic sensor; and b) detecting a change in the temperature and / or metabolic sensor, thereby determining the presence of an infection. In various embodiments of the present invention, the detecting step may be a series of detections over time, where the changes in the sensor are used to assess the presence or onset of an infection. In further embodiments, a change in temperature or metabolic factor over time (e.g., 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4 hours, 12 hours, 1 day, or 2 days) of 0.5%, 1.0%, or 1.5% increase may be indicative of the presence (or onset) of an infection.

[0074]

[0085] In various embodiments of the invention, an antibiotic can be delivered to prevent or inhibit an infection, or to treat an infection after it has been detected. Representative examples of suitable antibiotics are well known and are described above in Section B ("Therapeutic Agents").

[0075] (0086) E. Further Use of Sensor-Integrated Prosthetic Knee Joints, Medical Devices and Kits in Health Care Post-operative progress can be monitored (comparing measurements daily, weekly, etc.) and information can be accumulated and communicated to both the patient and their physician to guide subsequent rehabilitation and comparison to expected (typical population) norms. In certain embodiments, the wearable device selectively or irregularly queries the sensors and captures and / or stores the collected sensor data. This data can then be downloaded to another system or device (described in more detail below).

[0076] (0087) By integrating data collected by the sensors described herein (e.g., contact sensors, position sensors, strain gauges, and / or accelerometers) with simple, widely available, commercially available analytical technologies, such as pedometers and Global Positioning Satellite (GPS) capabilities, additional clinically important data can be collected. Such data includes, but is not limited to, the patient's degree of ambulation (time, distance, stride length, speed, cadence), the patient's activity level (frequency, duration, intensity of activity), exercise tolerance (work, calories, force, training effect), range of motion (discussed in more detail below), and prosthetic performance under various "real world" conditions. The usefulness of this information in enabling better management of the patient's recovery is difficult to overstate. The attending physician (or physical therapist, rehabilitation specialist) only observes the patient momentarily during routine appointments. The degree of functioning of the patient at the moment of examination may be influenced by numerous miscellaneous factors, such as the presence or absence of pain, the presence or absence of inflammation, stiffness, time of day, compliance and timing of medication use (analgesics, anti-inflammatory drugs), recent activity and exercise levels, the patient's physical strength, mental state, language barriers, the nature of their doctor-patient relations knee, and even the patient's ability to clearly express his or her symptoms. Continuous monitoring and data collection provide patients and physicians with objective information on the patient's functioning under numerous conditions and circumstances, allowing them to objectively monitor progress, evaluate how different interventions (pain management, exercise, physical therapy, anti-inflammatory drug therapy, rest, etc.) affect performance, and compare rehabilitation progress with previous and future expected functioning. Observing the effects of different treatments on the patient's rehabilitation, activity, function, and overall ability would benefit both the physician and the patient, and would likely improve treatment decisions and patient compliance.

[0077]

[0088] The sensors used for contact, strain, accelerometer, and position detection may be of any acceptable type commonly available (see, for example, U.S. Pat. Nos. 7,450,332, 7,463,997, and 7,924,267, which describe various types of such sensors, such as strain gauges, accelerometers, and MEMs sensors that can operate as many other sensing functions). The particular sensor described in U.S. Pat. No. 7,450,332 that detects the free fall of an object and the motion of an object relative to a gravitational field is particularly useful in that it can detect and store all forces acting on the leg and the total motion of the leg before, during, and after impact with the ground during passive and active movement, and as the leg swings between steps.

[0078]

[0089] As an example of the above, FIG. 4 illustrates the use of a sensor during a patient physical exam and various data that can be obtained from a sensor inserted according to the teachings herein. The sensor provides assessment data regarding the range of motion (ROM) of the knee. Currently, ROM is typically measured clinically during a physical exam by a physician passively moving the knee through its full range of motion and recording the results (flexion, extension, abduction, adduction, external rotation, internal rotation, and degree of rotation in flexion). Using motion sensors and accelerometers, the full ROM of the prosthetic knee can be accurately determined intraoperatively (if surgical adjustments are required), during a post-operative physical exam, and during normal daily activities between appointments. As shown in FIG. 11A, a key component of knee health is the angle X that the patient is able to achieve at each point during physical therapy as they recover from surgery. As angle X becomes smaller and smaller, the physician can be more confident that joint function is improving. By tracking the angle X over time, the physical therapist can monitor the patient's progress and evaluate whether scar tissue formation, subluxation, or other pathology is limiting / affecting the ROM of the knee and modify / implement treatment as necessary. With sensors inserted as described herein, the physical therapist or physician does not have to guess the angle achieved, but rather, when the leg is placed adjacent to the reading computer, the exact angle is known at the moment the joint is clinically evaluated. On the other hand, if X does not continue to decrease and remains large (or increases), this alerts the physical therapist or physician that there may be a problem with the patient's rehabilitation or delayed recovery from surgery, and the physical therapist or physician can investigate and / or treat early. Similarly, the embodiment of FIG. 11B can perform measurements when the user holds the leg at a precise 90 degree angle Y, as shown. When the leg is held firmly at 90 degrees, data can be collected from various sensors throughout the leg, thereby determining strain, contact location, acceleration, and other data. The position sensor used herein can alert the patient as to whether their leg is being held firmly at 90 degrees, allowing accurate data to be collected at each point over several months of monitoring the patient.Although the cited figures show flexion and extension, it will be apparent to one skilled in the art that data can also be collected on medial / lateral and anterior / posterior stability of the joint, subluxation (if present), and tracking of the knee joint and patella. Additionally, the patient can be monitored between appointments by analyzing the ROM that occurs during daily activities when the patient is at home.

[0079] (0090) As noted above, in another aspect of the invention, there is provided a method of imaging a knee prosthesis or medical device as described herein. The method includes the steps of (a) detecting the location of one or more sensors on the knee prosthesis or medical device, and (b) visually displaying the location of the one or more sensors to generate an image of the knee replacement component or medical device. In various embodiments, the detecting step can be performed over time, and thus the visual display can show the movement of the location over time. In certain preferred embodiments, the image displayed is a three-dimensional image. In other embodiments, imaging techniques can be utilized post-operatively to inspect the knee replacement component or medical device and / or to compare the operation and / or operation of the device over time.

[0080]

[0091] Certain exemplary embodiments are described in detail below. One particular advantage is real-time in situ monitoring of the patient's recovery and the inserted prosthesis 10. The sensors described herein collect data continuously during normal daily activities and, if desired, overnight. That is, strains can be measured, collected, and stored periodically over an extended period of time, with certain measurements being taken at regular intervals. For example, contact sensors can acquire and report data once every 10 seconds, once a minute, or once a day. Other sensors can collect data more frequently, such as several times per second. For example, acceleration and position data can be expected to be collected and stored several times per second. Other types of data may only need to be collected on a minute or hourly basis. Still other sensors can only collect data when the patient signals (via an external signal / actuator) to do so as part of an "event record", i.e. when the patient experiences a particular event (e.g., pain, injury, instability, etc.) and signals the device to read out at that time, allowing subjective / symptom data to be compared with objective / sensor data for the purpose of gaining a deeper understanding of the root cause or trigger of the patient's symptoms. Since the tibial stem has a large internal portion that may be hollow or a solid bar of metal, this internal structure has more than enough space to house one or more processor circuits, CPUs, memory chips, and other electrical circuits, as well as antennas for transmitting and receiving data. The processor can be programmed to collect data from the various sensors on a desired schedule set by the medical professional. All activities can be continuously monitored post-operatively, and data can be collected and stored in a memory located within the implant.

[0081] (0092) A patient will typically undergo periodic medical checkups. When the patient goes to the doctor's office for the checkup, the doctor places a reader close to the prosthesis 10, in this example a knee replacement component, which transfers data from the implant's internal circuitry to the doctor's office database. The use of wireless transmission using smart cards or other technologies is well known in the art and need not be described in detail. Examples of such wireless transmission of data are provided in the published patent applications and patents mentioned herein. Data collected over the past weeks or even months based on the patient's movements and leg use is immediately transferred from the memory placed in the implant to the doctor's computer or wireless device. The computer then analyzes the data for anomalies, unexpected changes over time, positive or negative trends, and other indications that may be indicative of the patient's health or the operability of the prosthesis. In addition, the doctor can collect data that lists a record of any effects on the joint, such as the magnitude and direction of acceleration. If the physician notices a high acceleration event, such as a patient fall or other physical activity or exercise, the physician can be alerted to ask the patient if there were any problems at the time of the fall or to warn the patient that too vigorous activity may cause damage to the knee implant. For example, if the patient decides to go skiing or jogging, the physician can monitor the effects of such activity on the prosthesis 10, such as the acceleration and strain during the event itself. The physician can then look at the condition of the prosthesis in the hours and days after the event and compare it to the pre-event data to determine if the particular event caused long-term damage, such as prosthesis separation from the surrounding bone tissue or joint subluxation, or if the activity subjected the prosthesis to stress / strain / impact forces beyond the manufacturer's performance specifications for the particular artificial joint. Data can be collected and compared regarding the ongoing and long-term performance of the prosthesis from strain gauges, contact sensors, surface wear sensors, or other sensors that may be present.

[0082] (0093) Alternatively, the patient may have a reader at home that checks the data from the prosthesis periodically, such as once a day or once a week. As mentioned above, the patient may also "activate" the reading of the device (via an external signal / activation device) as part of the "event record". By empowering the patient to monitor their own rehabilitation and to see the positive (or negative) impact of various lifestyle choices on their health and rehabilitation, compliance and patient outcomes may be improved. Furthermore, their experience may be shared with other patients via the web to compare their progress against the expected "norm" of function and rehabilitation, and to alert patients to signs and symptoms that should be brought to the physician's attention. The performance of different implants may be compared across patients (of different genders, weights, activity levels, etc.) to help manufacturers design better prostheses and to assist orthopedic surgeons in selecting the right prosthesis for a particular patient type. Payers, patients, manufacturers, and physicians may all benefit from the collection of this comparative information. Additionally, data accumulated at home could be collected and transmitted via the internet to a clinic for analysis, potentially eliminating unnecessary doctor's visits in some cases and prompting urgent medical follow-up for others.

[0083] (0094) F. Power Generation In one aspect of the invention, a small generator can be placed along the outer surface of the implant, or alternatively along the inner surface of the implant. Specifically, with each step taken by the user, there is a release of pressure and an increase in pressure within the internal structure of the implant. Using suitable piezoelectric materials or micro-generators, a small amount of electricity can be generated with each step. The electricity can be stored in a capacitor that is also integrated within the implant. The electricity can then be used to power sensors located at various locations within the prosthesis.

[0084] (0095) Various techniques have been described for harvesting electricity from small mechanical movements or vibrations. See, for example, the paper "Piezoelectric Power Scavenging of Mechanical Vibration Energy" by UK Singh et al., October 2-4, 2007, pp. 111-118. The paper gives examples of various types of generators that can generate electricity from very small movements and store it for later use. The paper also describes embodiments that generate power without the need for movement, but rather as a result of applying high pressure, by applying pressure from a specific structure and releasing the pressure. As described in the embodiments herein, when a patient takes a step, weight is applied to the leg, which exerts a force on the internal structure of the implant, and the force can generate more than enough power to operate all the sensors described herein. Other mechanisms for generating electricity from very small repetitive movements are described in U.S. Patent Application Publication No. 2010 / 0164705, published July 1, 2010. This patent application describes a technique for harvesting energy from the rotation of a tire that can be used to power a variety of sensors that can then output collected data at selected intervals to a central collection location. Other sensors of this type are described in U.S. Patent No. 7,603,894, entitled "Self-Powered Tire Monitoring System."

[0085]

[0096] In a preferred embodiment, the power generation system is stationary and relies only on the pressure applied during a step and the release of pressure when the step is completed and the leg swings off the ground for the next step. Because there is no movement, the patient does not feel slight changes in the position or length of the implant while walking. Rather, the length is kept constant and electricity is generated by a piezoelectric structure or by an internal suspended structure that is not part of the implant's support structure.

[0086]

[0097] After electricity is generated by one or more generators, it is transmitted to any one of the various sensors described herein. For example, it can be transmitted to a contact sensor 22, a strain gauge 26, an accelerometer 27, or a position sensor 28. It can also be transmitted to other sensors described herein. Transmission of power can be by any acceptable technique. For example, wires can run from the generator to a particular sensor if the sensor is physically coupled to the implant. Alternatively, electricity can be transmitted wirelessly using a suitable transmitting and receiving antenna in the same manner that a wireless smart card receives power from a nearby power source. Such power transmitting and receiving techniques are also described in the aforementioned publications and patent applications and issued U.S. patents, all of which are incorporated herein by reference.

[0087] (0098) G. Medical Imaging and Self-Diagnosis, Predictive Analytics, and Predictive Maintenance of Assemblies Including Total Knee Replacement Components The present invention provides knee replacement components that can be imaged with sensors for a wide variety of conditions. For example, in various aspects of the present invention, a method of imaging a knee replacement component (or portion thereof (e.g., a medical device or kit described herein) having sensors, or an assembly including a knee replacement component, medical device or kit (as described herein), is provided. The method includes detecting changes over time in sensors in, on, and / or within the knee replacement component, medical device or kit, where the knee replacement component, medical device or kit includes sensors at a density of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 sensors per square centimeter. In another aspect, the knee replacement component, medical device or kit includes sensors at a density of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 10 sensors per cubic centimeter. In some embodiments, the sensor density is 9, 10, or more than 10. In any of these embodiments, there can be less than 50, 75, 100, or 100 sensors per square centimeter or per cubic centimeter. In various embodiments, at least one or more sensors can be randomly or at one or more specific locations within the total knee replacement member, medical device, or kit described herein. As mentioned above, a wide variety of sensors can be utilized, such as, for example, contact sensors, strain gauge sensors, pressure sensors, flow pressure sensors, position sensors, pulse pressure sensors, blood volume sensors, blood flow sensors, blood chemistry sensors, blood metabolism sensors, mechanical stress sensors, and temperature sensors.

[0088] (0099) For example, a knee replacement component, medical device, or kit including the sensors described herein can be used to image the knee anatomy through sensors capable of detecting positional movement. The sensors used can also include accelerometers and motion sensors to detect the movement of the knee prosthesis due to various physical changes. The change in position of the accelerometer and / or motion sensor over time can be used to measure the change in position of the knee prosthesis over time. Such change in position can be used as a surrogate marker of the knee anatomy. That is, an "image" of the knee prosthesis can be formed to provide information regarding the size, shape, and positional changes of the knee prosthesis and / or the movement / movement of the knee prosthesis. For example, loosening of the knee prosthesis can cause undesired movement of the prosthesis relative to the bone in which it is inserted during activity or weight bearing. The sensors can be used in the present invention to determine the undesired movement or degree of movement during various movements and activities. Similarly, monitoring changes in the joint cavity over time (i.e., changes in the space separating the femoral and tibial components) can be used as an indicator of erosion and wear of the articular surfaces (femoral and / or tibial sides). Additionally, tracking the movement of the sensor throughout the range of motion can provide a dynamic "picture" of the joint, allowing the clinician to monitor both improvement and deterioration of joint function (and surrounding tissues) over time.

[0089] (00100) H. Method for monitoring an assembly including a total knee replacement component As mentioned above, the present invention also provides a method of monitoring one or more of the knee prosthesis assemblies shown herein. For example, FIG. 10 shows a monitoring system that can be used with a knee prosthesis 10 of the type shown in any one of the above figures. The monitoring system includes a sensor (e.g., 22, 26, 27, and / or 28), an interrogation module 124, and a control unit 126. The sensor (e.g., 22, 26, 27, and / or 28) can be passive and wireless, capable of operating with power received from a wireless power source. Such sensors are well known in the art and are widely used. This type of pressure sensor can be a MEMS pressure sensor, for example, part number LPS331AP, available from STMicroelectronics. MEMS pressure sensors are well known to operate with very low power and are suitable for long periods of unpowered standby. The MEMS pressure sensor can be powered wirelessly with an RF signal, sense pressure based on the power received wirelessly with the RF signal, and then output the sensed data.

[0090] (00101) In one embodiment, a power generation system (as described above) is provided that can be utilized to power the sensors described herein. As shown in FIG. 10, in operation, the interrogation module 124 outputs a signal 128. The signal 128 is a wireless signal, typically in the RF band, that contains power for the sensor (e.g., 22, 26, 27, and / or 28) and is an interrogation request for the sensor to perform sensing. When interrogated with the signal 128, the sensor (e.g., 22, 26, 27, and / or 28) powers up and stores enough power in an on-board capacitor to continue operating during sensing and data reporting. Such power receiving circuits and storage in on-board capacitors are well known in the art and need not be described in detail. Appropriate sensing is performed by the sensor (e.g., 22, 26, 27, and / or 28), and then data is output from the sensor and returned to the interrogation module 124 with a signal 130, where it is received at an input port of the interrogation module.

[0091] (00102) According to one embodiment, the initial signal 128 provides sufficient signal strength to power the sensor, perform the sensing operation, and output a signal back to the interrogation module 124. In other embodiments, two or more signals 128 are sent, each providing additional power to the sensor to enable it to complete the sensing operation and then provide enough power to return data to the interrogation module 124 via the signal path 130. For example, the signal 128 can be sent continuously with a sensing request component at the beginning of the signal, and then continue to provide power to operate the sensor, either as a steady signal or as a pulse. When the sensor is ready to output data, it sends a signal to the interrogation module 124 to let it know data is coming, and the signal 128 can be turned off to avoid interference. Alternatively, the integrated signal 128 can be at a first frequency and the output signal 130 at a second frequency, separated enough so that they do not interfere with each other. In a preferred embodiment, they are both at the same frequency, so that the same antenna of the sensor receives the signal 128 and transmits the signal 130.

[0092] (00103) The interrogation signal 128 may include data to select a particular sensor on the prosthesis. For example, the signal 128 may collect data from all sensors 22 with one interrogation signal 128 by powering up all sensors on the prosthesis at the same time and then sending a data request to each at a selected different time, providing one interrogation signal 128 for a set period of time, e.g., 1-2 seconds, so that each sensor on the prosthesis collects data during this period and then at the end of this period reports the data with each signal 130 at a different time over the next 0.5-2 seconds.

[0093]

[00104] Interrogation module 124 operates under the control of control unit 126, which contains a microprocessor for the controller, memory, I / O circuitry for interfacing with the interrogation module, and a power supply. The control unit outputs data to a computer or other device for display or use by a physician to treat the subject.

[0094] (00105) FIG. 11 illustrates operation according to a preferred embodiment within a subject's body. The subject has an integument 132. As shown in FIG. 13, the interrogation module 124 and the control unit 126 are located outside the subject's skin 132. The interrogation signal 128 is a wireless RF signal that passes through the subject's skin, and data is received from the sensors (e.g., 22, 26, 27, and / or 28) back to the interrogation module 124 as a wireless RF signal 130. The wireless signal can be in any frequency range, but the RF range is preferred. Frequencies in the VLF to LF range of 3-1300 kHz allow the signal to reach a sufficient depth within the body at low power, although frequencies below 3 kHz and above 1300 kHz can also be used. Sensing does not require the transmission of large amounts of data, and low power is preferred. Thus, a low frequency RF signal is sufficient. This avoids conflicts with and false triggers from other wireless signal generators, e.g., Bluetooth, mobile phones, etc.

[0095] (00106) I. Collection, transmission, analysis, and distribution of data from an assembly including a total knee replacement component FIG. 12 illustrates one embodiment of an information and communication technology (ICT) system 800 arranged to process sensor data (e.g., data from the sensors (e.g., 22, 26, 27, and / or 28) of any one of the figures illustrated herein). In FIG. 12, the ICT system 800 is illustrated as including computing devices communicating over a network 804, although in other embodiments the computing devices may communicate with each other directly or through other intervening devices, and in some cases the computing devices may not communicate at all. The computing devices of FIG. 12 include a computing server 802, a control unit 126, a query unit 124, and other devices not illustrated for simplicity.

[0096] 12, one or more sensors (e.g., 22, 26, 27, and / or 28) communicate with an interrogation module 124. The interrogation module 124 of FIG. 12 receives instructions from a control unit 126, but in other cases, the interrogation module 124 operates autonomously to communicate with the sensors 22. Either or both of the interrogation module 124 and the control unit 126 can be in communication with the calculation server 802.

[0097]

[00108] In certain embodiments, the interrogation module and / or control unit may be a wearable device worn by the subject. The wearable device (e.g., a watch-type device, glasses, wristband, or other device that may be carried or worn by the subject) may interrogate the sensors over set (or irregular) times, collect data, and transmit the data to one or more networks (804). Additionally, the wearable device may autonomously collect data, which may also be transmitted to the network. Representative examples of data that may be collected include location (e.g., GPS), body or skin temperature, and other physiological data (e.g., pulse rate). In yet other embodiments, the wearable device may directly notify the subject of any of a number of predefined conditions, including, but not limited to, potential or actual failure of the device.

[0098]

[00109] Information communicated between interrogation module 124 and the sensors (e.g., 22, 26, 27, and / or 28) can be useful for many purposes, as described herein. In some cases, for example, sensor data information is collected to specifically analyze the health of an individual subject. In other cases, the sensor data is collected and transferred to another computing device and aggregated with other data (e.g., sensor data from 22 may be collected and aggregated with other data collected from a wearable device (e.g., which in certain embodiments may include GPS data, etc.)).

[0099] 12 illustrates an embodiment of a computation server 802 that is a federated collection of servers that further includes computation servers 802a, 802b, and one or more other servers 802n. It is understood that computation server 802 can include any number of computation servers acting individually or collectively for the benefit of users of the computation servers.

[0100]

[00111] In some embodiments, the computation server 802 is deployed as a cloud computing device located in one or more geographic locations, such as the United States or Canada. The cloud computing device may be located as a MICROSOFT AZURE cloud computing device or any other virtually accessible remote computing service.

[0101]

[00112] The interrogation module 124 and the control unit 126 are optionally shown in communication with the computation server 802. Sensor data is transferred to (and additionally or alternatively from) the computation server 802 via the interrogation module 124 or the control unit 126 over the network 804.

[0102]

[00113] Network 804 may include some or all of a cellular communications network, a traditional cable network, a satellite network, a fiber optic network, etc., configured as one or more local area networks, wide area networks, personal area networks, and any other type of computing network. In a preferred embodiment, network 804 includes any communications hardware and software that work in cooperation to enable users of computing devices to view and interact with other computing devices.

[0103]

[00114] The computing server 802 includes a central processing unit (CPU) digital signal processor (DSP) 808, a communication module 810, an input / output (I / O) module 812, and a storage module 814. The components of the computing server 802 are cooperatively connected by one or more buses 816 that facilitate the transmission and control of information within and through the computing server 802. The communication module 810 can be configured to communicate information between the computing server 802 and other computing devices (e.g., the computing servers 802a, 802b, 802n, the control unit 126, the interrogation unit 124, etc.). The I / O module 812 can be configured to receive input from devices such as a keyboard, a computer mouse, a trackball, etc. The I / O module 812 can be configured to provide output to devices such as a display, a recorder, an LED, an audio device, etc.

[0104]

[00115] The storage module 814 may include one or more types of storage media. For example, the storage module 814 of FIG. 12 includes a random access memory (RAM) 818, a read only memory (ROM) 810, a disk-based memory 822, an optical memory 8124, and other types of memory storage media 8126. In some embodiments, one or more memory devices of the storage module 814 have configured thereon one or more database structures. The database structures can be used to store data collected from the sensor 22.

[0105]

[00116] In some embodiments, the storage module 814 may further include one or more memory portions organized as a non-transitory computer readable medium (CRM). The CRM is configured to store operational instructions executable by the CPU 808. The operational instructions may be stored as one or more files, and each file may include one or more computer programs. The computer programs may be stand-alone programs or part of a larger computer program. Alternatively, or additionally, each file may include data or other computer support material for an application that directs the collection, analysis, processing, and / or distribution of data from a sensor (e.g., a knee replacement component sensor). A sensor data application typically executes a set of instructions stored on a computer readable medium.

[0106]

[00117] It will be understood that the computational servers shown in the figures and described herein are merely exemplary and are not intended to limit the scope of the invention. Computational server 802 may connect to other devices, not shown, through one or more networks, such as the Internet, or via a web-based network 804. More generally, a computing system or device (e.g., a "client" or "server"), or any portion thereof, may optionally include any combination of hardware capable of interacting and performing the types of functions described when programmed or otherwise configured with software, including, but not limited to, desktop or other computers, database servers, network storage devices and other network devices, PDAs, cell phones, wireless phones, eyeglasses, wristbands, pagers, electronic organizers, Internet appliances, television-based systems (e.g., using set-top boxes and / or personal / digital video recorders), and various other products with appropriate intercommunication capabilities. Additionally, the functionality provided by the illustrated system modules may be combined into fewer modules or distributed among additional modules in some embodiments. Similarly, in some embodiments, some of the functionality of the illustrated modules may not be provided and / or other additional functionality may be available.

[0107]

[00118] Additionally, while various items are shown as being stored in memory or storage while in use, these items, or portions thereof, may be transferred between memory and other storage for memory management and / or data integrity. In at least some embodiments, the illustrated modules and / or systems are software modules / systems that include software instructions that, when executed by the CPU / DSP 808 or other processor, program the processor to automatically perform the described operations for the module / system. Alternatively, in other embodiments, some or all of the software modules and / or systems may execute in memory on another device and communicate with the illustrated computing system / device via computer-to-computer communications.

[0108]

[00119] Furthermore, in some embodiments, some or all of the modules and / or systems may be implemented or provided otherwise, for example, at least partially using firmware and / or hardware, including, but not limited to, one or more application specific integrated circuits (ASICs), standard integrated circuits, controllers (e.g., executing appropriate instructions and including microcontrollers and / or embedded controllers), field programmable gate arrays (FPGAs), complex programmable logic devices (CPLDs), etc. Some or all of the systems, modules, or data structures may also be stored (e.g., as software instructions or structured data) on a temporary or non-transitory computer readable storage medium 814, such as a hard disk 822 or a flash drive or other non-volatile storage device 8126, a volatile memory 818 or a non-volatile memory 810, a network storage device, or a portable media object (e.g., a DVD disk, a CD disk, an optical disk, a flash memory device, etc.) and read by an appropriate input or output system or via an appropriate connection. In some embodiments, the systems, modules, and data structures may also be transmitted as a generated data signal (e.g., as part of a carrier wave or other analog or digital propagated signal) over a variety of computer-readable transmission media, such as wireless-based media and wire / cable-based media. The data signal may take a variety of forms, such as a single analog signal or as part of a multiplexed analog signal, as a plurality of discrete digital packets or frames, as discrete digital bits, or some other form. Such computer program products may take other forms in other embodiments. Accordingly, the invention may be practiced with other computer system configurations.

[0109] 12, for example, sensor data from sensors (e.g., 22, 26, 27, and / or 28) is provided to computational server 802. In general, sensor data is data received from known subjects and known sensors. The sensor data may include or be further associated with additional information such as a USI, UDI, timestamp, location (e.g., GPS) stamp, date stamp, and other information. The difference between various sensors is that some may include more or fewer data bits that tie the data to a particular source, collection device, transmission characteristics, etc.

[0110] (00121) In some embodiments, the sensor data may include sensitive information, such as personal health information associated with a particular subject. Sensitive information, such as sensor data from sensors (e.g., 22, 26, 27, and / or 28), may include any information that an interested party desires not to be widely or easily disseminated. Sensitive information may be separate or combined with other non-sensitive information. For example, a subject's medical information is typically sensitive information. In some cases, the storage and transmission of a subject's medical information is protected by government mandates (e.g., laws, regulations, etc.), such as the U.S. Health Insurance Portability and Accountability Act (KNEEPA).

[0111]

[00122] As used herein, references to "confidential" information include information that is entirely confidential or any combination of confidential and non-confidential information. Confidential information may be represented in a data file or in some other form. As used herein, a data file containing a subject's medical information may be referred to as "confidential information." Other information, such as employment information, financial information, identity information, and many other types of information, may similarly be considered confidential information.

[0112]

[00123] The computing system may represent sensitive information in an encoding algorithm (e.g., ASCII), in a well-known file format (e.g., PDF), or in some other format. In the computing system, the sensitive information may be protected from wide or easy dissemination with an encryption algorithm.

[0113]

[00124] In general, sensitive information may be stored in a computing system as a discrete collection of data bits. The collection of data bits may be referred to as "plaintext." Furthermore, a computing system may use cryptographic processes to convert the plaintext into a highly difficult-to-read collection of data bits (i.e., ciphertext) using an encryption algorithm (i.e., a cipher). A computing system with knowledge of the encryption key used to create the ciphertext can restore the information to its plaintext, readable state. Thus, in some cases, sensitive data (e.g., sensor data 806a, 806b) may be optionally encrypted before being communicated to a computing device.

[0114]

[00125] In one embodiment, the operation of the information and communication technology (ICT) system 800 of Figure 12 includes one or more sensor data computer programs stored on a computer readable medium. The computer programs can optionally instruct and / or receive data from one or more total knee replacement component sensors inserted into one or more subjects. The sensor data computer programs may execute on the computing server 802. Alternatively or additionally, the sensor data computer programs may execute on the control unit 126, the interrogation unit 124.

[0115]

[00126] In one embodiment, a computer program directing the collection and use of knee replacement component sensor data is stored in a non-transitory computer readable medium in the storage module 814. The computer program is configured to identify a subject having a wireless knee replacement prosthesis inserted therein. The wireless knee replacement prosthesis may include one or more wireless sensors.

[0116]

[00127] In some cases, the computer program identifies one subject, and in other cases, two or more subjects are identified, each of which may have one or more wireless knee replacement components, and each wireless knee replacement may have one or more wireless sensors of the type described herein.

[0117]

[00128] A computer program is arranged to direct the collection of sensor data from the wireless knee prosthesis device. The sensor data is typically collected by a wireless interrogation unit 124. In some cases, the program communicates with the wireless interrogation unit 124. In other cases, the program communicates with a control unit 126, which in turn instructs the wireless interrogation unit 124. In other cases, some other mechanism is used to direct the collection of the sensor data.

[0118]

[00129] After the sensor data is collected, the data may be further processed. For example, in some cases, the sensor data includes sensitive subject data that can be removed or separated from the data. The sensor data can be stored individually (e.g., by unique sensor identification number, device number, etc.) or aggregated with other sensor data by sensor type, time stamp, location stamp, date stamp, subject type, other subject characteristics, or by some other means.

[0119]

[00130] The following pseudocode description is used to illustrate one example of an algorithm generally executed by calculation server 802 and generally described herein with respect to FIG. start Open Secure Sockets Layer (SSL) Identifying subjects Communicate with pre-determined control units Request sensor data from the subject via the control unit Requesting Sensor Data If the sensor data is encrypted Deciphering Sensor Data Save the encrypted data to the destination of your choice Integrating sensor data with other sensor data Save the encrypted data to the destination of your choice Keeping a record of memory transactions Perform post-save processing end

[0120]

[00131] Those skilled in the art will appreciate that implementing devices and / or processes and / or systems and then integrating the implemented devices and / or processes and / or systems into more comprehensive devices and / or processes and / or systems using optical techniques and / or other practices is commonly known in the art, i.e., at least some of the devices and / or processes and / or systems described herein can be integrated into other devices and / or processes and / or systems through a reasonable amount of experimentation. Examples of such other devices and / or processes and / or systems, depending on the context and application, may include all or part of devices and / or processes and / or systems such as: (a) air transportation (e.g., airplanes, rockets, helicopters, etc.); (b) ground transportation (e.g., automobiles, trucks, locomotives, tanks, armored personnel carriers, etc.); (c) buildings (e.g., homes, warehouses, offices, etc.); (d) appliances (e.g., refrigerators, washers, dryers, etc.); (e) communications systems (e.g., networked systems, telephone systems, voice over IP systems, etc.); (f) enterprises (e.g., Internet Service Provider (ISP) enterprises, such as Comcast Cable, Qwest, Southwestern Bell, etc.); or (g) wireline / wireless service enterprises (e.g., Sprint, Cingular, Nextel, etc.).

[0121]

[00132] In certain cases, use of the system or method may occur even when components are located outside the domain. For example, in a distributed computing context, use of a distributed computing system may occur even when parts of the system are located outside the domain (e.g., repeaters, servers, processors, signal bearing media, sending computers, receiving computers, etc., located outside the domain).

[0122]

[00133] Similarly, a sale of a system or method may occur even if components of the system or method are located and / or used outside the territory. Further, implementing at least a portion of a system outside a territory to perform a method does not preclude use of the system in another territory.

[0123] (00134) In conclusion, a knee prosthesis with multiple sensors can be used to serve multiple clinically important functions, such as safe, accurate, and less traumatic placement of the knee prosthesis, procedural and postoperative "real-time" imaging of the knee prosthesis and surrounding anatomical structures, development of knee replacement complications, and overall patient health. Currently, postoperative evaluation of knee replacement patients (both inpatient and outpatient) is performed through patient history, physical examination, and medical monitoring, with the addition of imaging tests as needed. However, most of the patient's recovery period occurs between visits in the hospital or clinic, and most data regarding daily function is not collected. Furthermore, monitoring of the patient's progress using any imaging technique is expensive, invasive, and may involve health risks to the patient (use of nuclear isotopes and certain dyes). Therefore, it is very difficult to accurately measure and track the onset or deterioration of symptoms, and to evaluate "real-life" knee prosthesis performance, especially with respect to the patient's activity level, exercise tolerance, the effectiveness of rehabilitation efforts, and drug therapy.

[0124] (00135) Currently, physicians and patients lack the kind of "real-time," continuous, objective measurements of knee prosthesis performance that they would like to have. The ability to monitor the function, integrity, anatomy, and physiology of the knee prosthesis in situ could provide valuable, objective information to the physician during the clinic visit. Additionally, patients could take additional readings at home at various times (e.g., when experiencing pain, during exercise, after medication, etc.) to provide important supplemental clinical information to the physician (information that could even be transmitted electronically to the healthcare provider remotely). From the patient's perspective, the ability to monitor many of these same parameters at home could allow them to take a more active role in their own treatment and recovery, and could provide early indications to seek medical help or provide reassurance.

[0125] (00136) As an option, the patient may have a reading device at home that periodically cross-checks data from the knee prosthesis, such as once a day or once a week. In addition to empowering the patient to monitor their own rehabilitation and allowing them to see the positive (or negative) effects of various lifestyle choices on their health and rehabilitation, access to such information may improve compliance and improve patient outcomes. For example, in certain embodiments, the devices and systems described herein may prompt or otherwise inform the patient, or an authorized third party, of deviations (e.g., greater than 10%, 20%, 25%, 50%, 70%, and / or 100%) from normal and / or set parameters. Additionally, the patient may share their recovery experience with other patients via the web, compare their progress to expected "norms" of function and rehabilitation, and alert the patient to signs and symptoms that should be brought to the attention of a physician. From a public health perspective, the performance of different knee prostheses could be compared across patients with different genders, disease severity, activity levels, comorbidities such as hypertension and diabetes, smoking status, obesity, etc., to help manufacturers design better knee prostheses and to help physicians select the right knee prosthesis for a particular patient type. Payers, patients, manufacturers, and physicians could all benefit from the collection of this comparative information. It would be possible to identify poor quality or unsafe products and remove them from the market, and to collect and analyze objective long-term effectiveness data. Also, data accumulated at home could be collected and transmitted via the Internet to clinics for analysis, potentially eliminating unnecessary visits in some cases and encouraging urgent medical follow-up for others.

[0126]

[00137] Below, some embodiments of the systems and processes disclosed herein are specifically numbered and described. These embodiments are by way of example only. It should be understood that the present invention is not limited to the embodiments described herein for purposes of illustration, but covers all such forms that fall within the scope of the disclosure above. 1) at least one of a tibial component, a patellar prosthesis, and a femoral component; a plurality of sensors connected to at least one of the tibial component, the artificial patella prosthesis, and the femoral component; An artificial knee joint comprising: 2) The artificial knee joint of embodiment 1, wherein the plurality of sensors includes a sensor on the tibial component. 3) The artificial knee joint of embodiment 1, wherein the plurality of sensors includes sensors on the artificial patellar prosthesis. 4) The artificial knee joint of embodiment 1, wherein the plurality of sensors includes a sensor on the femoral component. 5) The artificial knee joint according to any one of embodiments 1 to 4, wherein the sensor is selected from the group consisting of an accelerometer, a pressure sensor, a contact sensor, a position sensor, a chemical microsensor, a tissue metabolism sensor, a mechanical stress sensor, and a temperature sensor. 6) The artificial knee joint of embodiment 5, wherein the accelerometer detects acceleration, tilt, vibration, impact, and / or rotation. 7) The artificial knee joint of embodiment 1, wherein the plurality of sensors includes a plurality of contact sensors located on the femoral component. 8) The artificial knee joint of embodiment 1, wherein the plurality of sensors includes a plurality of contact sensors located on the patella component. 9) The artificial knee joint of embodiment 1, wherein the plurality of sensors includes a plurality of contact sensors located on the tibial component. 10) A medical device comprising a femoral component of an artificial knee joint and a plurality of sensors coupled to the femoral component. 11) A medical device comprising an artificial patellar prosthesis for an artificial knee joint and a plurality of sensors connected to the artificial patellar prosthesis. 12) A medical device comprising a tibial component of a total knee replacement and a plurality of sensors connected to the tibial component. 13) A medical device according to any one of embodiments 10 to 12, wherein the sensor is found inside and / or on the surface of the medical device. 14) A medical device described in any one of embodiments 10 to 13, wherein the sensor is selected from the group consisting of an accelerometer, a pressure sensor, a contact sensor, a position sensor, a chemical microsensor, a tissue metabolism sensor, a mechanical stress sensor, and a temperature sensor. 15) The medical device of embodiment 14, wherein the accelerometer detects acceleration, tilt, vibration, impact, and / or rotation. 16) An electronic processor located on and / or on the medial side of at least one of the tibial component, the patellar prosthesis, and / or the femoral component, electrically connected to a sensor. The artificial knee joint according to any one of embodiments 1 to 9 or the medical device according to any one of embodiments 10 to 15, further comprising: 17) An artificial knee joint or medical device as described in embodiment 16, wherein the electrical connection is a wireless connection. 18) A memory coupled to the electronic processor and located on and / or on the medial side of at least one of the tibial component, the patellar prosthesis, and the femoral component. 18. The knee prosthesis or medical device of embodiment 17, further comprising: 19) An artificial knee joint or medical device according to any one of embodiments 1 to 18, wherein the sensor is a plurality of sensors located on or within the artificial knee joint at a density of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more than 20 sensors per square centimeter. 20) The artificial knee joint or medical device according to any one of embodiments 1 to 19, wherein the sensor is a plurality of sensors located on or within the artificial knee joint replacement component at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or 20 sensors per cubic centimeter. 21) obtaining contact data from contact sensors disposed at multiple locations on and / or within the patient's knee prosthesis or medical device according to any one of embodiments 1-20; storing the data on a memory device located on or within the knee prosthesis or medical device; and transferring the data from the memory external to the prosthetic knee joint or medical device. 22) obtaining strain data from strain sensors positioned at a plurality of locations on the patient's knee prosthesis or medical device; storing the strain data in a memory located in the prosthetic knee joint or medical device; transferring the strain data from the memory to a memory located external to the prosthetic knee joint or medical device; 23. The method of embodiment 22, further comprising: 23) obtaining contact data from a contact sensor disposed in the knee prosthesis or medical device according to any one of embodiments 1 to 19 of a patient; storing the contact data in a memory located in the prosthetic knee joint or medical device; transferring the data from the memory to a memory located external to the prosthetic knee joint or medical device; 23. The method of embodiment 22, further comprising: 24) obtaining acceleration data from accelerometers positioned at multiple locations on the knee prosthesis or medical device according to any one of embodiments 1-19, the knee prosthesis or medical device being positioned in situ on the patient's knee; storing the acceleration data in a memory located in the prosthetic knee joint or medical device; transferring the acceleration data from the memory of the artificial knee joint or medical device to a memory located external to the artificial knee joint or medical device; The method includes: 25) A kit comprising an artificial knee joint or medical device described in any one of embodiments 1 to 19, further comprising bone cement and / or a bone screw comprising one or more sensors. 26) The kit of embodiment 25, wherein the one or more sensors are selected from the group consisting of an accelerometer, a pressure sensor, a contact sensor, a position sensor, a chemical microsensor, a tissue metabolism sensor, a mechanical stress sensor, and a temperature sensor. 27) The kit according to embodiment 25 or 26, wherein the sensors are found at a density of more than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or 20 sensors per square centimeter on the prosthesis or medical device. 28) The knee prosthesis, medical device or kit according to any one of embodiments 1-20 or 25-27, wherein the one or more sensors are randomly located within the knee prosthesis, medical device or kit. In other embodiments, the sensors can be located at specific locations within the knee prosthesis, medical device or kit. 29) A method for detecting and / or recording events in a subject having an artificial knee joint or medical device as described in any one of embodiments 1 to 28, comprising the steps of interrogating activity of one or more sensors within the artificial knee joint or medical device at a desired time point and recording the activity. 30) The method of embodiment 29, wherein the interrogation step is performed by a subject having an artificial knee joint or medical device inserted. 31) The method of embodiment 30, wherein the recording step is performed on a wearable device. 32) The method of any one of embodiments 29 to 31, wherein the recording step is provided to a healthcare provider. 33) (a) detecting the position of one or more sensors in the knee prosthesis, medical device, or kit according to any one of embodiments 1-20 or 25-27; (b) generating an image of the knee prosthesis or medical device by visually displaying the location of the one or more sensors; A method for imaging the artificial knee joint, medical device, or kit according to any one of embodiments 1 to 20 or 25 to 27, comprising: 34) The method of embodiment 33, wherein the detection step is performed over time. 35) The method of embodiment 34, wherein the visual indication indicates a change in the position of the sensor over time. 36) A method according to any one of embodiments 33 to 35, wherein the visual display is a three-dimensional image of the artificial knee joint or medical device. 37) (a) inserting a medical device according to any one of embodiments 1-20 or 25-27 into a subject; (b) imaging the placement of the medical device according to the method of any one of embodiments 33 to 36; A method for inserting the artificial knee joint, medical device, or kit according to any one of embodiments 1 to 20 or 25 to 27, comprising: 38) A method for inspecting an artificial knee joint, medical device or kit described in any one of embodiments 1 to 20 or 25 to 27 that has been previously inserted into a patient, comprising a step of imaging the artificial knee joint or medical device by a method described in any one of embodiments 33 to 36. 39) A method for monitoring a knee prosthesis, medical device, or kit within a subject, comprising the steps of transmitting a wireless electrical signal from a location outside the subject's body to a location within the body; Receiving a signal at a center located on the knee prosthesis, medical device or kit according to any one of embodiments 1 to 20 or 25 to 27, located inside the body; powering a sensor using the received signal; sensing data with the sensor; outputting the sensed data from the sensor to a receiving unit located outside the body; The method includes: 40) The method of embodiment 39, wherein the receiving unit is a watch, a wristband, a mobile phone, or glasses. 41) The method of embodiment 39 or 40, wherein the receiving unit is located in the subject's home or office. 42) The method of any one of embodiments 39 to 41, wherein the sensed data is provided to a healthcare provider. 43) A method according to any one of embodiments 39 to 42, wherein the sensed data is posted to one or more websites. 44) A non-transitory computer-readable storage medium having stored thereon content for configuring a computing system to perform a method, the method comprising: Identifying a subject, the identified subject having at least one of the wireless knee prosthesis, medical device, or kit according to any one of embodiments 1 to 20 or 25 to 27, each of the wireless knee prosthesis, medical device, or kit having one or more wireless sensors; instructing a wireless interrogation unit to collect sensor data from at least one of each of the one or more wireless sensors; receiving the collected sensor data; A non-transitory computer readable storage medium comprising: 45) The non-transitory computer-readable storage medium having stored thereon contents that configure a computing system to perform a method, Identifying a plurality of subjects, each of the identified subjects having at least one of a wireless knee prosthesis, a medical device, or a kit, each of the wireless knee prosthesis, the medical device, or the kit having one or more wireless sensors; instructing a wireless interrogation unit associated with each of the identified subjects to collect sensor data from at least one of the respective one or more wireless sensors; and receiving the collected sensor data. aggregating the collected sensor data; 45. The non-transitory computer-readable storage medium of embodiment 44, further comprising: 46) The non-transitory computer-readable storage medium having stored thereon contents for configuring a computing system to perform a method, removing sensitive subject data from the collected sensor data; analyzing the collected data according to the type of sensor; 45. The non-transitory computer-readable storage medium of embodiment 44, further comprising: 47) The non-transitory computer-readable storage medium, the contents of which are stored thereon configure a computing system to perform a method, and the step of instructing the wireless interrogation unit includes the step of instructing a control unit associated with the wireless interrogation unit. The non-transitory computer-readable storage medium of embodiment 44. 48) A non-transitory computer-readable storage medium described in any one of embodiments 44 to 47, wherein the artificial knee joint, medical device, or kit is an assembly described in any one of embodiments 1 to 20 or 25 to 27. 49) A storage medium according to any one of embodiments 44 to 48, wherein the collected sensor data is received by a watch, a wristband, a mobile phone, or glasses. 50) A storage medium described in any one of embodiments 44 to 49, wherein the collected sensor data is received within the subject's home or office. 51) A storage medium described in any one of embodiments 44 to 50, wherein the collected sensory data is provided to a healthcare provider. 52) A storage medium described in any one of embodiments 44 to 51, wherein the sensed data is posted to one or more websites. 53) The method according to any one of embodiments 39 to 43 or the storage medium according to any one of embodiments 44 to 52, wherein the data is analyzed. In certain embodiments, the data can be analyzed to assess the subject's range of motion. In other embodiments, the data can be analyzed to detect bone erosion, inflammation, wear and / or deterioration of the surface of the knee prosthesis, medical device or kit (or any part thereof), and / or possible or potential damage. 54) The method or storage medium of embodiment 53, wherein the data is displayed to enable visualization of changes over time. 55) A method or storage medium according to embodiment 53 or 54, wherein the data is displayed to provide a three-dimensional image. 56) A method for determining deterioration of an artificial knee joint, medical device, or kit, comprising the steps of: a) providing to a subject an artificial knee joint, medical device, or kit described in any one of embodiments 1 to 20 or 25 to 27; and b) detecting a change in a sensor, thereby determining deterioration of the artificial knee joint, medical device, or kit. 57) The method of embodiment 56, wherein the sensor is capable of detecting one or more physiological parameters and / or position parameters. 58) The method of embodiment 56 or 57, wherein the sensor detects contact, flow rate, pressure, and / or temperature. 59) A method according to any one of embodiments 56 to 58, wherein the sensor detects a position within the subject's body. 60) A method according to any one of embodiments 56 to 59, wherein the sensor moves within the body as the artificial knee joint deteriorates. 61) A method according to any one of embodiments 56 to 60, wherein the detection step is a series of detections over time. 62) A method for determining an infection associated with an artificial knee joint, medical device, or kit, comprising: a) providing to a subject an artificial knee joint, medical device, or kit described in any one of embodiments 1-20 or 25-27, wherein the artificial knee joint, medical device, or kit includes at least one temperature sensor and / or metabolic sensor; and b) detecting a change in the temperature sensor and / or metabolic sensor, thereby determining the presence of an infection. 63) The method of embodiment 62, wherein the detection step is a series of detections over time. 64) The method of embodiment 62 or 63, wherein the change is greater than 1% in 1 hour. 65) The method of any one of embodiments 62 to 64, wherein the change is a sustained increase in temperature and / or metabolic activity over a period of 4 hours.

[0127]

[00138] The various embodiments described above can be combined to form further embodiments. The U.S. patents, U.S. patent application publications, U.S. patent applications, foreign patents, foreign patent applications, and non-patent publications mentioned herein are incorporated by reference in their entirety. Aspects of the embodiments can be modified as necessary to employ concepts from the various patents, applications, and publications and provide further embodiments.

[0128]

[00139] In general, the terms used in the following embodiments should not be construed to limit the embodiments to the specific embodiments and embodiments disclosed herein, but should be construed to include all possible embodiments along with the full scope of equivalents to be given to such embodiments. Thus, the embodiments are not limited to the present disclosure.

Claims

1. At least one of a tibial component, a patellar prosthesis, and a femoral component; a plurality of sensors coupled to at least one of the tibial component, the patellar prosthesis, and the femoral component; An artificial knee replacement prosthesis comprising:

2. The knee replacement prosthesis of claim 1 , wherein the plurality of sensors includes a sensor on the tibial component.

3. The knee replacement prosthesis of claim 1 , wherein the plurality of sensors includes sensors on the prosthetic patellar prosthesis.

4. The knee replacement prosthesis of claim 1 , wherein the plurality of sensors includes a sensor on the femoral component.

5. The knee replacement prosthesis of any one of claims 1 to 4, wherein the sensor is selected from the group consisting of an accelerometer, a pressure sensor, a contact sensor, a position sensor, a chemical microsensor, a tissue metabolism sensor, a mechanical stress sensor, and a temperature sensor.

6. The knee replacement prosthesis of claim 5 , wherein the accelerometer detects acceleration, tilt, vibration, shock, and / or rotation.

7. The knee replacement prosthesis of claim 1 , wherein the plurality of sensors includes a contact sensor located on the femoral component.

8. The total knee replacement prosthesis of claim 1 , wherein the plurality of sensors includes a plurality of contact sensors located on the patella component.

9. The knee replacement prosthesis of claim 1 , wherein the plurality of sensors includes a plurality of contact sensors located on the tibial component.

10. A medical device comprising a femoral component of a total knee replacement prosthesis and a plurality of sensors coupled to the femoral component.

11. A medical device comprising: a patellar prosthesis for a total knee replacement prosthesis; and a plurality of sensors connected to the patellar prosthesis.

12. A medical device comprising a tibial component of a total knee replacement and a plurality of sensors coupled to the tibial component.

13. A medical device according to any one of claims 10 to 12, wherein the sensor is found within and / or on the surface of the medical device.

14. The medical device according to any one of claims 10 to 13, wherein the sensor is selected from the group consisting of an accelerometer, a pressure sensor, a contact sensor, a position sensor, a chemical microsensor, a tissue metabolism sensor, a mechanical stress sensor, and a temperature sensor.

15. The medical device of claim 14 , wherein the accelerometer detects acceleration, tilt, vibration, shock, and / or rotation.

16. The knee prosthesis according to any one of claims 1 to 9 or the medical device according to any one of claims 10 to 15, further comprising an electronic processor located on and / or on the medial side of at least one of the tibial component, the patellar prosthesis and / or the femoral component in electrical connection with a sensor.

17. 17. The knee prosthesis or medical device of claim 16, wherein the electrical connection is a wireless connection.

18. 20. The knee prosthesis or medical device of claim 17, further comprising a memory connected to the electronic processor and located on and / or medial to at least one of the tibial component, the patellar prosthesis, and the femoral component.

19. 19. The knee prosthesis or medical device of any one of claims 1 to 18, wherein the sensor is a plurality of sensors located on or within the knee replacement component at a density of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or greater than 20 sensors per square centimeter.

20. 20. The knee replacement prosthesis or medical device of any one of claims 1 to 19, wherein the sensor is a plurality of sensors located on or within the knee replacement component at a density of 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or greater than 20 sensors per cubic centimeter.

21. Obtaining contact data from contact sensors positioned at a plurality of locations on and / or within a total knee replacement prosthesis or medical device according to any one of claims 1 to 20 of a patient; storing the data in a memory device located on or within the total knee replacement prosthesis or medical device; transferring the data from the memory external to the total knee replacement prosthesis or medical device; The method includes:

22. obtaining strain data from strain sensors positioned at a plurality of locations on the patient's total knee replacement prosthesis or medical device; storing the strain data in a memory located in the total knee replacement prosthesis or medical device; transferring the strain data from the memory to a memory external to the total knee replacement prosthesis or medical device; 23. The method of claim 22, further comprising:

23. obtaining contact data from a contact sensor located on a total knee replacement prosthesis or medical device according to any one of claims 1 to 19 of a patient; storing the contact data in a memory located on the total knee replacement prosthesis or medical device; transferring the data from the memory to a memory located external to the total knee replacement prosthesis or medical device; 23. The method of claim 22, further comprising:

24. obtaining acceleration data from accelerometers located at a plurality of positions on a total knee replacement prosthesis or medical device according to any one of claims 1 to 19, the total knee replacement prosthesis or medical device being located in situ on a patient's knee; storing the acceleration data in a memory located in the total knee replacement prosthesis or medical device; transferring the acceleration data from the memory of the total knee replacement prosthesis or medical device to a memory located external to the total knee replacement prosthesis or medical device; The method includes:

25. A kit comprising a knee replacement prosthesis or medical device according to any one of claims 1 to 19, further comprising bone cement and / or a bone screw comprising one or more sensors.

26. 26. The kit of claim 25, wherein the one or more sensors are selected from the group consisting of an accelerometer, a pressure sensor, a contact sensor, a position sensor, a chemical microsensor, a tissue metabolism sensor, a mechanical stress sensor, and a temperature sensor.

27. 27. The kit of claim 25 or 26, wherein the sensors are found at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or 20 sensors per square centimeter on the prosthesis or medical device.

28. The knee replacement component, medical device or kit of any one of claims 1 to 20 or 25 to 27, wherein one or more sensors are positioned within the knee replacement component, medical device or kit and / or at specific locations within the knee replacement component, medical device or kit randomly.

29. A method for detecting and / or recording events in a subject having a total knee replacement component or medical device as described in any one of claims 1 to 28, comprising the steps of interrogating activity of one or more sensors within the total knee replacement component or medical device at desired times and recording said activity.

30. 30. The method of claim 29, wherein the interrogation step is performed by a subject inserting a knee replacement component or medical device.

31. The method of claim 30 , wherein the recording step is performed on a wearable device.

32. The method of any one of claims 29 to 31, wherein the recording step is provided to a healthcare provider.

33. (a) detecting the position of one or more sensors in a total knee replacement component, medical device or kit according to any one of claims 1 to 20 or 25 to 27; (b) creating an image of the total knee replacement component or medical device by visually displaying the location of the one or more sensors; A method for imaging a total knee replacement component, medical device or kit according to any one of claims 1 to 20 or 25 to 27, comprising:

34. 34. The method of claim 33, wherein the detecting step is performed over time.

35. 35. The method of claim 34, wherein the visual indication indicates a change in position of the sensor over time.

36. The method of any one of claims 33 to 35, wherein the visual representation is a three-dimensional image of the total knee replacement component or medical device.

37. (a) inserting into a subject a medical device according to any one of claims 1 to 20 or 25 to 27; (b) imaging the placement of the medical device according to a method according to any one of claims 33 to 36; A method of inserting a total knee replacement component, medical device or kit according to any one of claims 1 to 20 or 25 to 27, comprising:

38. A method for inspecting a total knee replacement component, medical device or kit according to any one of claims 1 to 20 or 25 to 27, which has been previously inserted into a patient, comprising a step of imaging the total knee replacement component or medical device according to a method according to any one of claims 33 to 36.

39. 1. A method for monitoring a knee replacement component, medical device, or kit in a subject, comprising: transmitting a wireless electrical signal from a location outside the subject's body to a location inside the body; receiving a signal at a center located on a total knee replacement component, medical device or kit according to any one of claims 1 to 20 or 25 to 27, the total knee replacement component, medical device or kit being located inside the body; powering a sensor using the received signal; sensing data with the sensor; outputting the sensed data from the sensor to a receiving unit located outside the body; The method includes:

40. 40. The method of claim 39, wherein the receiving unit is a watch, a wristband, a mobile phone, or glasses.

41. 41. The method of claim 39 or 40, wherein the receiving unit is located in the subject's home or office.

42. The method of any one of claims 39 to 41, wherein the sensed data is provided to a health care provider.

43. The method of any one of claims 39 to 42, wherein the sensed data is posted to one or more websites.

44. A non-transitory computer-readable storage medium having stored thereon content for configuring a computing system to perform a method, the method comprising: Identifying a subject, the identified subject having at least one of a wireless total knee replacement component, a medical device or a kit according to any one of claims 1 to 20 or 25 to 27, each of the wireless total knee replacement components, medical devices or kits having one or more wireless sensors; instructing a wireless interrogation unit to collect sensor data from at least one of each of the one or more wireless sensors; receiving the collected sensor data; A non-transitory computer readable storage medium comprising:

45. The non-transitory computer-readable storage medium having stored thereon contents that configure a computing system to perform a method, the method comprising: Identifying a plurality of subjects, each of the identified subjects having at least one of a wireless total knee replacement component, a medical device, or a kit, each of the wireless total knee replacement components, medical devices, or kits having one or more wireless sensors; instructing a wireless interrogation unit associated with each of the identified subjects to collect sensor data from at least one of the one or more respective wireless sensors; receiving the collected sensor data; aggregating the collected sensor data; 45. The non-transitory computer-readable storage medium of claim 44, further comprising:

46. The non-transitory computer-readable storage medium having stored thereon contents that configure a computing system to perform a method, the method comprising: removing sensitive subject data from the collected sensor data; analyzing the aggregated data according to sensor type; 45. The non-transitory computer-readable storage medium of claim 44, further comprising:

47. 45. The non-transitory computer readable storage medium of claim 44, the contents of which configure a computing system to perform a method, wherein instructing the wireless interrogation unit includes instructing a control unit associated with the wireless interrogation unit.

48. The non-transitory computer readable storage medium according to any one of claims 44 to 47, wherein the knee replacement component, medical device or kit is an assembly according to any one of claims 1 to 20 or 25 to 27.

49. The storage medium of any one of claims 44 to 48, wherein the collected sensor data is received by a watch, a wristband, a mobile phone, or glasses.

50. The storage medium of any one of claims 44 to 49, wherein the collected sensor data is received within a subject's home or office.

51. The storage medium of any one of claims 44 to 50, wherein the collected sensory data is provided to a health care provider.

52. The storage medium of any one of claims 44 to 51, wherein the sensed data is posted to one or more websites.

53. The method of any one of claims 39 to 43 or the storage medium of any one of claims 44 to 52, wherein the data is analysed.

54. 54. A method or storage medium according to claim 53, wherein the data is displayed to enable visualization of changes over time.

55. 55. A method or storage medium according to claim 53 or 54, wherein the data is displayed to provide a three-dimensional image.

56. A method for determining deterioration of a total knee replacement component, medical device or kit, comprising the steps of: a) providing to a subject a total knee replacement component, medical device or kit according to any one of claims 1 to 20 or 25 to 27; and b) detecting a change in a sensor, thereby determining deterioration of the total knee replacement component, medical device or kit.

57. 57. The method of claim 56, wherein the sensor is capable of detecting one or more physiological parameters and / or location parameters.

58. 58. The method of claim 56 or 57, wherein the sensor detects contact, flow, pressure, and / or temperature.

59. 59. The method of any one of claims 56 to 58, wherein the sensor detects a location within a subject's body.

60. 60. The method of any one of claims 56 to 59, wherein the sensor moves within the body as the total knee replacement component deteriorates.

61. 61. The method of any one of claims 56 to 60, wherein the detection step is a series of detections over time.

62. 28. A method for determining an infection associated with a total knee replacement component, medical device or kit, comprising the steps of: a) providing to a subject a total knee replacement component, medical device or kit according to any one of claims 1 to 20 or 25 to 27, the total knee replacement component, medical device or kit including at least one temperature and / or metabolic sensor; and b) detecting a change in the temperature and / or metabolic sensor, thereby determining the presence of an infection.

63. 63. The method of claim 62, wherein the detecting step is a series of detections over time.

64. 64. The method of claim 62 or 63, wherein the change is greater than 1% change in 1 hour.

65. 65. The method of any one of claims 62 to 64, wherein the change is a sustained increase in temperature and / or metabolic activity over a period of 4 hours.

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