Device, system and method for monitoring a knee replacement

Abstract

The present disclosure provides a knee replacement prosthesis including a plurality of sensors and at least one of a femoral component, a patellar prosthesis, and a tibial component.

Description

[0001] Cross-reference to related applications

[0002] This application is a divisional application of Chinese Patent Application No. 201480043961.9 and claims the benefit of U.S. Provisional Patent Application No. 61 / 838,317, filed on June 23, 2013, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present invention generally relates to knee replacements, and more specifically to apparatus and methods for monitoring the performance of total and partial knee replacements. Background Technology

[0004] Knee replacement surgery is one of the most common reconstructive orthopedic surgeries. It is performed when a patient cannot fully use their knee, typically due to the following causes: osteoarthritis, rheumatoid arthritis and other forms of arthritis (lupus, psoriasis, etc.), early knee injuries (ligament tears (anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament and / or lateral collateral ligament) and meniscus tears) and sequelae of early reconstructive surgery performed to treat these injuries, articular cartilage damage, joint dislocation, intra-articular fractures, and infection. Generally, surgery is used to treat extreme or persistent joint pain, loss of range of motion, impairment of walking ability, and / or loss and impairment of function in normal daily living activities; it is usually performed when there is evidence of significant loss or deterioration of all or part of the articular cartilage in the knee.

[0005] The knee is typically divided into three "chambers": the middle chamber (the articular surface on the medial side of the knee), the lateral chamber (the articular surface on the lateral side of the knee), and the patellofemoral chamber (the joint between the patella and the femur or thigh bone). Knee replacement can take many different forms depending on the degree of injury and / or disease. In a total knee replacement (TKR), both surfaces of the knee joint are replaced (i.e., the femoral and tibial articular surfaces are replaced with prostheses); depending on the degree of patellar damage, the patellar (kneecap) surface may or may not be replaced. In partial or unilateral knee replacements, only one or two of the middle, lateral, or patellofemoral portions of the joint are replaced (middle chamber replacement is the most common).

[0006] The components of a TKR typically include a femoral implant and a tibial implant (with or without replacing the surface of the patella). The femoral component consists of a rounded femoral condyle (usually metal, but can be ceramic), the tibial component consists of a flat metal shell (with or without a stalk extending into the tibial medullary canal) attached to the tibia using an inner polymer (usually polyethylene, but ceramic and metal can also be used), and the patellar component (if present) consists of a polymer "button" that engages with the posterior surface of the patella. Currently, the various components of a TKR can be made from a variety of different materials, including, for example, polyethylene, ultra-high molecular weight polyethylene, ceramic, surgical-grade stainless steel, cobalt-chromium, titanium, and various ceramic materials. In some devices, the femoral implant (usually made of metals such as stainless steel, titanium, or cobalt-chromium) and the metal portion of the tibial component (also usually made of metals such as stainless steel, titanium, or cobalt-chromium) can be designed with surface coatings to facilitate the integration of the implants within the femoral and tibial bones. The prosthesis may or may not be held in place using a bone-bonding agent (PMMA - polymethyl methacrylate). Representative examples of the components of knee replacement are described in U.S. Patents Nos. 5,413,604, 5,906,643, 6,019,794, and 7,922,771.

[0007] Figure 1 Total knee replacement and single-chamber (intermediate-chamber) knee replacement of known types in the art are shown. Figure 2 The components and materials of a typical artificial joint (10) are shown, including a metal tibial plate (5) and a tibial stem (2) (present in the figure, but some tibial plate components do not have stems), a polyethylene joint surface (7), a bonding agent (4) for holding the components in place, a patellar “button” prosthesis (8), and a femoral knee component 9. Figure 3 Another typical TKR is shown, which has a femoral component, a tibial plate, and a patellar button that can be attached to the underlying bone (opposite to the tibial plate) with screws and / or adhesive.

[0008] Unfortunately, when a complete knee implant is inserted, a variety of complications can occur intraoperatively, postoperatively, and over time. For example, intraoperatively, the surgeon may want to confirm the correct anatomical alignment of the prosthesis and / or any movement between the prosthesis and the surrounding bone to allow for adjustments during the procedure. Postoperatively, if there is slight movement, partial displacement (subluxation), or complete displacement of any component of the knee prosthesis, the patient may experience inflammation and pain. In the long term, gradual wear may occur between the femoral and tibial surfaces, leading to improper knee joint operation. Depending on the type of material used for the tibial and femoral surfaces, prolonged wear can lead to the formation of small debris particles, which can cause inflammation and bone erosion around the implant. When osteoporosis develops in the tissues around the implant over a period of time (e.g., 8–12 years) due to a process called osteolysis, related common complications arise, where osteoporosis leads to prosthesis loosening and eventual failure. All of the above acute and chronic complications can reduce knee performance, causing difficulty in movement and walking, and can cause pain and inflammation in the patient.

[0009] As mentioned, one of the most common and serious complications of TKR is peri-implant erosion (osteolysis), which can be caused by material fragments (metal, ceramic, and / or polyurethane fragments) generated by friction, leading to inflammation and osteoporosis. Other potential causes of inflammation and osteolysis include implant vibration and movement, improper patient use / activity, misalignment (including improper patellar tracking), non-obvious displacement (subluxation) of the tibiofemoral and patellofemoral joints, mechanical wear and tear, material failure or damage, loosening of the bond between bone and adhesive, lack of biocompatibility between implant material and surrounding bone, metal allergy, and lack of biocompatibility between bone adhesive and surrounding bone. The ability to detect these changes early and to correct or prevent them will be of great utility in the management of TKR patients. Other complications that can benefit from early detection and intervention include infection, fracture, implant micro-rupture, nerve impingement, deep vein thrombosis, loss of mobility, and instability.

[0010] Currently, postoperative inpatient monitoring of knee replacement surgery patients is conducted through: individual visits by hospital staff and the medical team, a physical examination of the patient, medical monitoring (vital signs, etc.), knee range of motion (ROM) assessment, physical therapy (including early mobilization and exercise), and necessary diagnostic imaging studies and blood tests. Once discharged, prosthesis performance and patient satisfaction are assessed during periodic physician office visits, where the entire medical history, physical examination, and supplemental imaging and diagnostic studies are used to monitor patient progress and identify the development of any potential complications. During these visits, the surgeon typically assesses knee range of motion, attempts to identify any pain occurring during specific activities or movements, and asks the patient about their level of activity, daily function, pain control, and rehabilitation progress.

[0011] Unfortunately, much of the patient's recovery period occurs between hospital or office visits. Therefore, it can be difficult to accurately measure and track the full range of motion (ROM, which varies depending on pain control, anti-inflammatory medication use, time of day, recent activity, and / or how the patient feels at the time of examination), "real-life" prosthesis performance, patient activity level, exercise tolerance, and the effectiveness of rehabilitation efforts (physiotherapy, medication, etc.) from the day of surgery until full recovery. For much of this information, physicians rely on patient self-reports or third-party observations to gain insight into the effectiveness of postoperative treatment and the recovery and rehabilitation process; this process is particularly complex in many cases for patients who are unsure what they are seeking, do not know what "normal / expected" postoperative recovery should be, are uncooperative, or cannot effectively communicate their symptoms. Furthermore, identifying and tracking complications (both in and out of the hospital) before they manifest symptoms between physician visits, or identifying and tracking complications that are difficult to detect, will provide valuable additional information for managing TKR and partial knee replacement patients. Currently, in all cases, neither doctors nor patients can achieve the type of "real-time," continuous, and objective prosthesis performance measurement they desire.

[0012] This invention discloses novel total or partial knee replacements that overcome many of the difficulties of previous knee prostheses. The invention also discloses methods for constructing and monitoring these novel knee replacements and further provides other related benefits. Summary of the Invention

[0013] In short, all or part of the knee prosthesis is equipped with multiple sensors to monitor the integrity and effectiveness of the artificial knee joint within the patient's body. The sensors may be located on the outer surface of the prosthetic knee, the inner surface of the prosthetic knee, within the prosthetic material itself (stainless steel, titanium, cobalt-chromium, polyurethane, high molecular weight polyurethane, ceramic, etc.), between various components including the prosthetic knee, screws and / or fastening hardware (if present) for securing the prosthesis in place, within the bone bonding agent (e.g., PMMA, or a PMMA and MMA copolymer blend) for securing the knee (if present), and / or within the tissue surrounding the prosthesis. In some embodiments, the sensors are passive and therefore do not require their own power source.

[0014] In one aspect of the invention, an assembly is provided for placing and positioning an implant in a patient's body, wherein the implant comprises a whole or part of a knee prosthesis; and one or more sensors disposed on, within, or around the prosthesis, and / or disposed within the bone bonding agent and / or bone screws or anchors for attaching the prosthesis. In other aspects of the invention, a medical device is provided comprising at least one of the following: a tibial component, a patellar prosthesis, or a femoral component, and one or more sensors. For clarity, one or more sensors may be intentionally disposed at a specific location on the knee replacement prosthesis, medical device, and / or bone screws or anchors, and / or randomly distributed throughout the knee replacement prosthesis, medical device, bone screws or anchors, and bone bonding agent, disposed on the knee replacement prosthesis, medical device, bone screws or anchors, and bone bonding agent, and disposed within the knee replacement prosthesis, medical device, bone screws or anchors, and bone bonding agent. Therefore, the use of the terms or phrases “located in,” “present,” or “utilizing” should not be construed as requiring specific positioning unless specific positioning is required.

[0015] In various embodiments, the sensor may be disposed on the outer surface of the prosthetic knee, on the inner surface of the prosthetic knee, within the material used to construct the prosthetic knee, between various components of the prosthetic knee and screws and / or fastening hardware (if present) for securing the prosthesis in position, on or in the bone bonding agent used to secure the prosthetic knee, on or in the tissue surrounding the prosthetic knee (typically bone or bone marrow, and muscles, ligaments, tendons, joint capsules, and / or synovium), or any combination thereof. Representative examples of sensors suitable for use in this invention include accelerometers (accelerometers for acceleration, tilt, vibration, shock, and rotation), pressure sensors, contact sensors, position sensors, chemical microsensors, tissue metabolism sensors, mechanical stress sensors, and temperature sensors. In a particularly preferred embodiment, the sensor is a wireless sensor or a sensor connected to a wireless microprocessor.

[0016] In another embodiment, multiple of the aforementioned sensors are disposed on, inside or around the prosthetic knee (bone bonding agent, bone screw or tissue), and in a preferred embodiment, the prosthetic knee may include two or more types of sensors (e.g. one or more of the following or any combination thereof: acceleration sensor, tilt sensor, vibration sensor, shock sensor, rotation sensor, pressure sensor, contact sensor, position sensor, chemical microsensor, tissue metabolism sensor and mechanical stress sensor).

[0017] According to various implementations, sensors are positioned at different locations within the replaced knee joint to monitor operation, movement, medical imaging (prosthesis and surrounding tissues), function, wear, performance, potential side effects, the patient's medical status, and the medical status of the artificial knee and its contact surface with the patient's living tissues. Real-time, continuous, in-situ monitoring of patient activity, patient function, prosthesis movement, prosthesis function, prosthesis performance, prosthesis and joint alignment, patellar orbital movement, prosthesis and joint forces and mechanical stresses, prosthesis and surrounding tissue anatomy (imaging), mechanical and physical integrity of the prosthesis, patellar orbital movement, and potential side effects is provided. Furthermore, information regarding many aspects of the knee replacement prosthesis and its interaction with the patient's own tissues is available, including clinically important measurements currently unavailable through physical examination, medical imaging, and diagnostic medicine research.

[0018] According to one implementation, the sensor provides assessment data regarding the knee's range of motion (ROM). Currently, ROM is typically measured clinically by passively moving the knee joint through its full range of motion during a physical examination by a physician and recording the results (flexion, extension, anterior / posterior stability, and medial / lateral stability). Figure 4 Motion sensors and accelerometers can be used to accurately determine the entire ROM of the prosthetic knee joint during physical examinations and normal daily activities between visits. Similarly, motion sensors and accelerometers can be used to accurately measure any anterior / posterior or medial / lateral instability (including complete displacement, partial displacement, or inconspicuous displacement) of the prosthetic knee joint during physical examinations and normal daily activities between visits. Additionally, motion sensors and accelerometers can be used to accurately measure any inappropriate on-track movement and / or instability of the patella (including complete displacement, partial displacement, or inconspicuous subluxation) during physical examinations and normal daily activities between visits.

[0019] According to one embodiment, contact sensors are positioned between the prosthesis and surrounding bone, between screws and / or fastening hardware (if present) and surrounding bone, between the prosthesis and surrounding bone bonding agent (if present), and / or between the bone bonding agent (if present) and surrounding bone to measure bone erosion and loosening around the implant. In other embodiments, vibration sensors are configured to detect vibrations between the prosthesis and surrounding bone, between screws and / or fastening hardware (if present) and surrounding bone, between the prosthesis and surrounding bone bonding agent, and between the bone bonding agent and surrounding bone as early indicators of movement and loosening. In other embodiments, strain gauges are configured to detect strain between the prosthesis and surrounding bone, between screws and / or fastening hardware (if present) and surrounding bone, between the prosthesis and surrounding bone bonding agent, between the bone bonding agent and surrounding bone, and strain acting on multiple portions of the prosthesis. A sudden increase in strain can indicate excessive stress on the replacement prosthesis, which may increase the risk of injury to the body. For example, a gradual, long-term decrease in strain may lead to bone resorption around the implant, causing loosening of the prosthesis or fracture of the bone around the prosthesis, while a gradual, long-term increase in strain may cause microfractures in the prosthesis material itself.

[0020] According to other embodiments, an accelerometer is provided that detects vibrations, shocks, tilts, and rotations. According to other embodiments, sensors for measuring surface wear (e.g., contact or pressure sensors) may be embedded at different depths within the femoral, tibial, and / or patellar articular surfaces to monitor articular surface erosion. In other embodiments, position sensors indicating range of motion and other types of sensors are provided to monitor partial (or complete) femoral-tibial-knee displacement or subluxation, inappropriate patellar orbital movement and / or patellofemoral joint subluxation, or movement between interconnecting components of the prosthesis (and anchoring hardware) itself over a period of time.

[0021] In another embodiment, the artificial knee (wholly or partially) may include sensors with a specific density at specific locations. For example, the artificial knee may have sensors present at a density greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 sensors per square centimeter (e.g., acceleration sensors, tilt sensors, vibration sensors, vibration sensors, rotation sensors, pressure sensors, contact sensors, position sensors, chemical microsensors, tissue metabolism sensors, and mechanical stress sensors, or any combination thereof). In another embodiment, the artificial knee (wholly or partially) may have sensors present at a density greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 sensors per cubic centimeter (e.g., acceleration sensors, tilt sensors, vibration sensors, vibration sensors, rotation sensors, pressure sensors, contact sensors, position sensors, chemical microsensors, tissue metabolism sensors, and mechanical stress sensors, or any combination thereof). In related embodiments, sensors (e.g., accelerometers, tilt sensors, vibration sensors, shock sensors, rotation sensors, pressure sensors, contact sensors, position sensors, chemical microsensors, tissue metabolism sensors, and mechanical stress sensors) may be located at specific locations on, in, or around the artificial knee (including, for example, the femoral component (middle, side, or both), tibial plate, tibial stem (if present), tibial liner, prosthetic patellar liner); within the parts of the device to be connected (e.g., the connection between the tibial cup and the tibial liner), screws and / or fastening hardware (if present) for securing the prosthesis in place; and around the artificial knee (on or in the bone graft for securing the prosthetic knee, on or in the tissue surrounding the prosthetic knee (typically bone or bone marrow, but may also be muscle, ligament, tendon, joint capsule, and / or synovium)).

[0022] In some embodiments of the invention, all or part of the knee prosthesis is provided with a specific unique identification number, and in other embodiments, each of the sensors on, in, or around the hip of the prosthesis has a specific unique identification number or group identification number (e.g., an identification number that identifies the sensor as an accelerometer, tilt sensor, vibration sensor, shock sensor, rotation sensor, pressure sensor, contact sensor, position sensor, chemical microsensor, tissue metabolism sensor, or mechanical stress sensor). In still other embodiments, the specific unique identification number or group identification number is specifically related to the location on, in, or around the knee of the prosthesis.

[0023] In other aspects of the invention, a method for monitoring an implanted whole or part of a 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 at a sensor disposed on, in, or around the artificial knee located inside the body; powering the sensor using the received signal; sensing data at the sensor; and outputting the sensed data from the sensor to a receiving unit located outside the body.

[0024] In other aspects of the invention, a method is provided for imaging a knee replacement or medical device provided herein, the method comprising the steps of: (a) detecting the position of one or more sensors in the knee replacement or medical device; and (b) visually displaying the position of the one or more sensors to form an image of the knee replacement or medical device. In various embodiments, the detection step may be performed over time, and the visual display may thus show the positional movement over time. In some embodiments, the displayed image is a two-dimensional or three-dimensional image. In a preferred embodiment, the images may be acquired and displayed in chronological order (e.g., as moving images or cinematic images).

[0025] The imaging techniques provided herein can be used for a variety of purposes. For example, in one aspect, the imaging techniques can be used during surgical procedures to ensure proper positioning and operation of knee replacements or medical devices. In other embodiments, the imaging techniques can be used postoperatively to examine knee replacements or medical devices, and / or to compare the operation and / or movement of the device over time.

[0026] The integrity of a partial or complete knee prosthesis can be wirelessly queried, and the results reported periodically. This allows for periodic or whenever the patient and / or physician desires to check the patient's health. Furthermore, the prosthesis can be wirelessly queried (via an external signaling / triggering device) as part of a "time log," whereby the patient signals / triggers the device to obtain simultaneous readings when experiencing a specific event (e.g., pain, injury, instability, etc.) to allow for comparison of subjective / symptom data and objective / sensor data. Matching time log data and sensor data can be used as part of efforts to better understand the underlying causes and specific triggers of a patient's particular symptoms. Therefore, in various embodiments of the invention, methods for detecting and / or recording events in an object having all or part of the knee replacements provided herein are provided, including querying at a desired time point. Thus, in one aspect of the invention, a method for detecting and / or recording events in an object having the knee replacements or medical devices provided herein is provided, comprising the steps of querying the activity of one or more sensors within the knee replacement or medical device at a desired time point and recording said activity. In various embodiments, these steps may be performed by the object and / or by a healthcare provider. In related embodiments, the recording steps can be performed using one or more wired devices or portable or wearable wireless devices (e.g., cellular phones, watches, wristbands, and / or glasses). In other embodiments, the wearable device (e.g., cellular phones, watches, wristbands, and / or glasses) may have sufficient processing power and memory capable of performing additional data acquisition and analysis.

[0027] In another embodiment, each of the sensors includes a signal receiving circuit and a signal output circuit. The signal receiving circuit receives an interrogation signal, which includes both an electrical component and a data acquisition request component. Using the power from the interrogation signal, the sensor powers on the portion of the circuitry that needs to be sensed, performs the sensing, and subsequently outputs a signal to the interrogation module. To drive the interrogation module, it operates under the control of a control unit, which includes appropriate I / O circuitry, memory, a controller in the form of a microprocessor, and other circuitry. In yet another embodiment, the sensor (e.g., an accelerometer, 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 such that it can be readily incorporated into or otherwise mechanically attached to the knee prosthesis (e.g., through an opening or other appendages providing permanent attachment of the sensor to the knee prosthesis) and / or readily incorporated into the bone graft or tissue surrounding the knee prosthesis.

[0028] In other aspects of the invention, a method apparatus is provided, adapted to: transmit wireless electrical signals from a location outside the body to a location inside the body; receive the signals at one of the aforementioned sensors disposed on, in, or around a prosthetic knee located inside the body; power the sensors using the received signals; sense data at the sensors; and output the sensed data from the sensors to a receiving unit located outside the body. In some embodiments, the receiving unit may provide analysis of the signals provided by the sensors.

[0029] Data collected by sensors can be stored in a memory located within the femoral component, tibial plate, and / or tibial stem. This data can be downloaded wirelessly via sensors during a doctor's visit, allowing the doctor to access data representing the prosthesis's real-time performance.

[0030] The benefits gained include more precise monitoring of the prosthesis and the ability to provide accurate, in-situ medical reports that will contribute to patient health. Details of one or more embodiments are set forth in the description below. Other features, purposes, and benefits will become clear from the specification, drawings, and claims. Furthermore, the entire disclosure of all patents and patent applications cited herein is incorporated herein by reference. Attached Figure Description

[0031] Figure 1 These are images of all knee replacements and single-chamber knee replacements.

[0032] Figure 2 It shows an exploded view of all the components of the knee replacement.

[0033] Figure 3 The components of another complete knee replacement are shown.

[0034] Figure 4 A representative range of motion (ROM) is shown for a subject with a full knee replacement.

[0035] Figure 5 The TKR with each contact sensor is shown.

[0036] Figure 6 The TKR with each strain gauge is shown.

[0037] Figure 7 The TKR with each accelerometer is shown.

[0038] Figure 8 The TKR with each position sensor is shown.

[0039] Figure 9 A TKR with a sensor configured to detect joint wear is shown.

[0040] Figure 10 An implementation of an information and communication technology system arranged to process sensor data is shown.

[0041] Figure 11 This is a block diagram of a sensor, interrogation module, and control unit according to one embodiment of the present invention.

[0042] Figure 12 This is a schematic diagram of one or more sensors positioned on a knee replacement within an object, according to one embodiment of the present invention, that are detecting and outputting data. Detailed Implementation

[0043] In short, this invention provides a variety of knee replacements that can be used to monitor the integrity and effectiveness of the device. However, before describing the invention, defining certain terms used below will aid in understanding it.

[0044] The terms "knee replacement" or "knee prosthesis" used in this article can refer to various forms and may involve the replacement of a patient's knee joint with synthetic materials, either in a total knee replacement (TKR) or a partial knee replacement (PDR). In a total knee replacement (TKR), the femoral and tibial sides are replaced. In a partial or unicompartmental knee replacement, only one or two parts of the knee (the tibial or femoral surface; or the intermediate, lateral, or patellar compartment) are replaced.

[0045] The multiple components of a TKR typically include a femoral implant, a patellar implant, and a tibial implant (which may consist of a tibial plate and tibial liner with or without a stem). Currently, these components can be made from a variety of different materials, including, for example, polyethylene, ultra-high molecular weight polyethylene, ceramic, surgical-grade stainless steel, cobalt-chromium, titanium, and various ceramic materials. In some devices, the femoral implant (typically made of metals such as stainless steel, titanium, or cobalt-chromium) may be designed with a bone surface coating to facilitate implant integration within the femur, and the tibial plate (and stem) may also have a surface coating to facilitate implant integration into the tibia. Representative examples of the various components of a knee replacement are described in U.S. Patents Nos. 5,413,604, 5,906,643, 6,019,794, and 7,922,771.

[0046] "Bone bonding agent" refers to a material that can be used between the prosthesis hardware and the surrounding bone and hardens in place upon cooling (or conversely, upon activation); it is a pharmaceutical agent used to secure one or more components of the prosthesis (prosthesis femoral surface, tibial plate / stem, patellar "button") to the appropriate bone tissue (femur, tibia, tibial medulla, patella). Bone bonding agents are typically composed of PMMA (polymethyl methacrylate) or a copolymer of PMMA and MMA. It should be noted that bone screws and / or other metal (or polymer) fixation devices may also be used to assist in anchoring prosthesis components to the surrounding bone tissue.

[0047] This invention provides knee prostheses (which may include full or partial implants), medical devices (e.g., a portion of a knee implant and / or components or materials useful during implantation), and kits (e.g., knee prostheses, medical devices, and additional necessary materials such as bone bonding agents and any associated delivery devices), all having sensors described in further detail below. The knee prostheses, medical devices, and kits provided herein (including associated materials such as bone bonding agents) are preferably sterile, non-pyrolytic, and / or suitable for human use and / or implantation in humans. However, in some embodiments of the invention, knee prostheses, medical devices, and / or kits may be manufactured in a non-sterile environment (or even customized as individual objects) and sterilized at a later date.

[0048] "Sensor" refers to a device that can be used to measure one or more different aspects of the body, a knee prosthesis inserted into the body, a medical device or kit, and the integrity, impact, effectiveness, or effect of the knee prosthesis, medical device, or kit inserted into the body. Representative examples of sensors suitable for use in this invention include, for example, fluid pressure sensors, contact sensors, position sensors, pulse pressure sensors, liquid (e.g., blood) volume sensors, liquid (e.g., blood) flow sensors, chemical sensors (e.g., for blood and / or other fluids), metabolic sensors (e.g., for blood and / or others), accelerometers, mechanical stress sensors, and temperature sensors. In some embodiments, the sensor may be a wireless sensor, or in other embodiments, the sensor may be a sensor connected to a wireless microprocessor. In other embodiments, one or more (including all) of the sensors may have a unique sensor identification number ("USI") that specifically identifies the sensor.

[0049] In this invention, various sensors (also known as microelectromechanical systems or "MEMS", or nanoelectromechanical systems or "NEMS", and BioMEMS or BioNEMS, generally referred to as...) can be utilized. https: / / en.wikipedia.org / wiki / MEMSRepresentative patents and patent applications include U.S. Patents Nos. 7,383,071 and 8,634,928, and U.S. Publications Nos. 2010 / 0285082 and 2013 / 0215979. Representative publications include: Albert Foch's "Introduction to BioMEMS" (2013), published by CRC Press; Marc J. Madou's "From MEMS to Bio-MEMS and Bio-NEMS: Manufacturing Techniques and Applications" (2011), published by CRC Press; Simona Badilescu's "Bio-MEMS: Science and Engineering Perspectives" (2011), published by CRC Press; Steven S. Saliterman's "Fundamentals of BioMEMS and Medical Microdevices" (2006), published by SPIE (The International Society of Optical Engineering); and works by Wanjun Wang and Steven... "Bio-MEMS: Technologies and Applications" edited by A. Soper and published by CRC Press in 2012; "Inertial MEMS: Principles and Practice" by Volker Kempe and published by Cambridge University Press in 2011; "Microdevices in Medicine" by Polla, DL et al. published in Ann. Rev. Biomed. Eng. 2000, 02: 551-576; and "Microdevices in Medicine" by Yun, KS et al. published in J. Microelectromechanical Sys.The following articles are cited: “A Surface-Tension Driven Micropump for Low-voltage and Low-Power Operations” (October 2002, 11:5, 454-461); “Single Mask, Large Force, and Large Displacement Electrostatic Linear Inchworm Motors” (August 2002, 11:4, 330-336, Yeh, R. et al.); and “Sub-10cm” (June 2002, 11:3, 182-187, Loh, NC et al.). 3 Interferometric Accelerometer with Nano-g Resolution (sub-10 cm⁻¹) 3 Interferometric accelerometer); all of the above content is incorporated in its entirety through quotation.

[0050] In various embodiments of the invention, the sensors described herein can be located in multiple locations and in various configurations, including within a knee prosthesis, medical device, or kit; within a knee prosthesis, medical device, or kit; and / or on the outer surface (or surface) of a knee prosthesis, medical device, or kit; and between a knee prosthesis, medical device, or kit and any device that may be carried therewith (e.g., a delivery or mounting device). As will be readily apparent from the disclosure provided herein, sensors can be simultaneously located at multiple locations on a knee prosthesis, medical device, or kit (i.e., within a knee prosthesis, medical device, or kit; within a knee prosthesis, medical device, or kit; and on the outer surface of a knee prosthesis, medical device, or kit). In some embodiments, the knee prosthesis, medical device, or kit, associated medical device (e.g., delivery device), or kit includes sensors with a density greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more per square centimeter. In other aspects, knee prostheses, medical devices or kits, and associated medical devices (e.g., delivery devices) or kits include sensors with a density greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more per cubic centimeter. In any of these embodiments, fewer than 50, 75, 100, or 100 sensors may be present per square centimeter or per cubic centimeter. In several embodiments, at least one or more of the sensors may be randomly distributed or located at one or more specific locations within the catheter, medical device, or kit as described herein.

[0051] In several implementations, the sensor may be located in a specific position and / or randomly positioned within the entire knee prosthesis, medical device or kit, associated medical device (e.g., delivery device) or kit. Furthermore, the sensor may be arranged in a specific pattern (e.g., the sensor may be arranged in an X-pattern, or in an ellipse or concentric ring around the knee prosthesis, medical device or kit, associated medical device (e.g., delivery device) or kit).

[0052] Representative implementations of knee prostheses, medical devices, and kits

[0053] To further understand the various aspects of the inventions provided herein, the following portions are provided: A. Knee prostheses, medical devices, and kits, and their use; B. Delivery of one or more therapeutic agents using knee prostheses, medical devices, and kits; C. Measurement of implant deterioration or wear using knee prostheses, medical devices, or kits with sensors; D. Methods for monitoring infection in knee prostheses, medical devices, and kits; E. Further use of knee prostheses, medical devices, and kits including sensors in healthcare; F. Generation of electricity from knee prostheses, medical devices, and kits; G. Medical imaging and self-diagnosis, predictive analytics, and predictive maintenance of components including knee prostheses, medical devices, and kits; H. Methods for monitoring components including knee prostheses, medical devices, and kits; and I. Acquisition, transmission, analysis, and distribution of data from components including knee prostheses, medical devices, and kits.

[0054] A. Knee prostheses, medical devices and kits and their use

[0055] Knee replacement surgery is performed when a patient's inability to fully utilize their knee results in disability, loss of mobility and function, impaired walking ability, and / or persistent joint pain and discomfort. Common causes of knee dysfunction leading to total or partial knee replacement include various types of arthritis (e.g., rheumatoid arthritis or osteoarthritis) and trauma (e.g., early knee ligament damage or cartilage / menstruation tears). For most patients, the surgery successfully improves walking, restores normal daily function, and reduces pain; therefore, knee replacement is a very common orthopedic surgery in the Western world.

[0056] Figure 5 , Figure 6 , Figure 7 , Figure 8 and Figure 9 Multiple prostheses 10 in the form of total knee replacements are shown, each having one or more sensors disposed on or within the prosthesis to sensitively and in-situ monitor the real-time operation of the prosthesis, the level of patient function and activity, and prosthesis performance over time. Various sensors will now be described according to several embodiments.

[0057] exist Figure 5In one embodiment shown, one or more contact sensors 22 are disposed throughout the implant, including contact sensor 22A distributed on and within the femoral condyle prosthesis-bone interface, contact sensor 22B distributed on and within the tibial bone-plate (and stem, if present) interface, and contact sensor 22C distributed on and within the patellar prosthesis (patellar "button")-patellar bone interface. In some embodiments, the contact sensors are located on the prosthesis components themselves (tibial portion, femoral portion, and patellar portion), while in other embodiments, the contact sensors are included on / within the osteosynthesis (if present) used to secure the prosthesis to the surrounding bone, and in still other embodiments, the contact sensors are included on / within both the prosthesis components and the osteosynthesis (PMMA).

[0058] In several embodiments, these sensors may be positioned on the prosthetic components in a variety of different patterns based on their contact positions relative to the surrounding bones (femur, tibia, and / or patella) and / or the surrounding bone bonding agent (if present). For example, the sensors may be arranged in an X-pattern, an ellipse or concentric ring around multiple components, or in a variety of other patterns to acquire precise data on the physical contact between the tibial component and the tibia and / or the surrounding bone bonding agent (if present), the femoral component and the femoral component and / or the surrounding bone bonding agent (if present), and the patellar component and the patella and / or the surrounding bone bonding agent (if present). Contact sensors may also be distributed / arranged within the bone bonding agent (if present) to acquire data on the physical contact between the bone bonding agent and the prosthetic components (femur, tibia, and patella) and / or between the bone bonding agent and the bones (femur, tibia, patella) themselves.

[0059] In various embodiments of the invention, contact sensors are disposed on the tibial, femoral, and / or patellar components of the knee prosthesis at a density greater than one, two, three, four, five, six, seven, eight, nine, or ten per square centimeter or per cubic centimeter of prosthetic device components and / or per cubic centimeter of bone bonding agent, and / or disposed in the bone bonding agent that secures the components of the prosthesis to the surrounding bone.

[0060] In other aspects of the method of the invention, a method is provided for imaging a knee replacement or medical device as provided herein, the method comprising the steps of: (a) detecting the position of one or more sensors in the knee replacement or medical device, and (b) visually displaying the position of the one or more sensors to form an image of the knee replacement or medical device. In several embodiments, the detection step may be performed over time, and thus the visual display may show positional movement over time. In some preferred embodiments, the displayed image is a three-dimensional image.

[0061] The imaging techniques provided herein can be used for a variety of purposes. For example, in one aspect, the imaging techniques can be used during surgery to ensure proper positioning and operation of knee replacements or medical devices. In other embodiments, the imaging techniques can be used postoperatively to examine knee replacements or medical devices, and / or to compare the operation and / or movement of the device over time.

[0062] In one embodiment, contact sensors 22 (22A, 22B, 22C) can detect loosening of the prosthesis 10 and its connection with the surrounding adhesive (if present) and / or bone. For example, a contact sensor (22B) located on / in the tibial component and / or on / in the bone adhesive surrounding the tibial component can detect loosening of the intratibial tibial component; this can be sensitively detected during surgery and alert the surgeon to the need for some intraoperative adjustments. Gradual loosening of the intratibial tibial component over time (compared to the postoperative level) is a common complication that occurs when osteoporosis occurs (e.g., due to a process known as osteolysis); this can also be detected by contact sensors on / in the tibial component and / or on / in the surrounding bone adhesive. In addition, contact sensors located between parts of the tibial component (e.g., between the tibial plate and the tibial liner) can detect abnormal movement, loosening, or wear between the component parts. These sensors can be “matched” (i.e., “paired” between adjacent components) to also allow for precise assembly during (and after) surgical placement.

[0063] Therefore, in Figure 5In the implementation described, multiple contact sensors are incorporated to monitor contact between multiple articular surfaces (intermediate and lateral tibiofemoral joints; patellar joints) in the presence of multi-chamber or single-chamber prosthetic knee joints. Specifically, complete or partial displacement (subluxation) of the femoral prosthesis articular surface from the natural or synthetic tibial articular surface (intermediate, lateral, or both) of the prosthetic knee is a common complication of knee replacement that frequently occurs shortly after surgery, especially during the postoperative recovery period when surrounding muscles and ligaments are still recovering from the surgery. Contact sensors on the femoral and / or tibial articular surfaces can alert patients and healthcare providers to the presence of joint displacement or subluxation. This is particularly valuable in detecting partial or incomplete displacement (subluxation) of the knee joint without clinical symptoms that are not easily detected by patients or physicians; this is of utmost concern during early repositioning and postoperative rehabilitation. In addition, contact sensors on multiple knee components determine whether the joint is working and aligned correctly (running along the track) during movement and activity. This is especially important for patellar movement, as precise patellar track movement is difficult to measure accurately in clinical practice; accurate measurement of patellar track movement during and after surgery would be beneficial.

[0064] exist Figure 6 In another embodiment shown, one or more strain gauges (or sensors) 26 are disposed throughout the implant, including strain gauges 26A distributed on and within the femoral condyle prosthesis-bone interface, strain gauges 26B distributed on and within the tibial bone-plate (and stem, if present) interface, and strain gauges 26C distributed on and within the patellar prosthesis (patellar "button")-patellar bone interface. In some embodiments, the strain gauges are located on the prosthesis components themselves (tibial portion, femoral portion, and patellar portion), while in other embodiments, the strain gauges are included on / within the osteosynthesis (if present) used to secure the prosthesis to the surrounding bone, and in still other embodiments, the strain gauges are included on / within both the prosthesis components and the osteosynthesis (PMMA).

[0065] In several embodiments, these strain gauges can be positioned on the prosthetic component in a variety of different patterns based on their contact position relative to the surrounding bones (femur, tibia, and / or patella) and / or the surrounding bone bonding agent (if present). For example, the strain gauges can be arranged in an X-pattern, an ellipse or concentric ring around multiple components, or in a variety of other patterns to acquire precise data on the physical strain experienced by the prosthetic component, the surrounding bone bonding agent (if present), and the surrounding bone (femur, tibia, patella) tissue.

[0066] In various embodiments of the present invention, strain sensors are disposed on the tibial component, femoral component, patellar prosthesis, and / or disposed in the bone bonding agent at a density of more than one, two, three, four, five, six, seven, eight, nine, or ten sensors per square centimeter of prosthetic component or per cubic centimeter of PMMA bone bonding agent.

[0067] Strain gauge 26 and contact sensor 22 provide different data points. Contact sensor 22 only indicates whether there is current contact between adjacent structures and thus provides a good indication of whether there is abutment contact between two surfaces. However, contact sensor 22 does not provide an indication of physical strain present on the prosthesis surface or in the surrounding bone; on the other hand, the data output by strain sensor 26 indicates mechanical strain applied to the implant, which, if not corrected, can be a precursor to future loosening and prosthesis failure. Furthermore, strain gauge 26 can indicate the type of strain present between two surfaces (e.g., between the tibial side and bone, between the femoral side and bone, between the patellar side and bone, between the prosthesis components (tibia, femur, and patella) and the bone graft, or between the tibial, femur, and patellar components themselves).

[0068] like Figure 6 As shown, strain gauges 26 are positioned at multiple locations on the tibial component to detect strain encountered between the tibial prosthesis and the surrounding tibial bone (and / or bone bonding agent, if present). Multiple tibial prostheses include a stalk extending into the tibial medullary canal to enhance anchorage and stability. A decrease in strain in the tibial prosthesis and / or tibial bonding agent can indicate the presence of a condition that could potentially lead to bone resorption (osteoporosis) in all or part of the tibial medullary canal; bone resorption can lead to prosthesis loosening or tibial fracture (conversely, increased strain will promote bone growth in the area). Therefore, strain sensors can provide an indication of strain present in the tibial axis and measure the most critical mechanical strain forces applied to the implant, if these forces are misaligned or uncorrected, indicating a high probability of prosthesis loosening and failure. An increase in strain can also indicate bone hypertrophy (growth) that can cause pain. The same forces exist between the femoral and patellar prosthesis components (and / or bone bonding agent) and at the interface between the femur and patella. For these purposes, the strain gauges 26 of the present invention can also be used for monitoring. "Real-life" stress information will benefit not only doctors and patients who can use data to determine the (positive and negative) effects of various activities on prosthetic bone health, but also manufacturers who can use it to design better prostheses.

[0069] exist Figure 7In another embodiment shown, one or more accelerometers 27 are disposed throughout the implant, including accelerometers 27A distributed on and within the femoral condyle prosthesis, accelerometers 27B distributed on and within the tibial plate (and stem, if present) and tibial liner, and accelerometers 26B distributed on and within the tibial plate (and stem, if present) and tibial liner, and accelerometers 27C distributed on and within the patellar prosthesis (patellar "button"). In some embodiments, the accelerometers are located on / within the prosthesis itself (tibial portion, femoral portion, and patellar portion), while in some other embodiments, the accelerometers are included in the osteosynthetic material (if present) used to secure the prosthesis to the surrounding bone, and in still other embodiments, the accelerometers are included on / within both the prosthesis components and the osteosynthetic material (PMMA).

[0070] In various embodiments, the accelerometer may be positioned within / on the prosthetic component in a variety of different patterns based on its contact location relative to the surrounding bones (femur, tibia, and / or patella), the surrounding bone bonding agent (if present), the joint interfaces between different prosthetic components (tibiofemoral and patellofemoral joints), and / or between sub-parts of the component (e.g., between the tibial plate and tibial liner). For example, the accelerometer may be arranged in an X-pattern, arranged as an ellipse or concentric ring around multiple components, or arranged within multiple components, or arranged in a variety of other patterns to acquire precise data experienced by the prosthetic component, the surrounding bone bonding agent (if present), and (by extension) the surrounding bone (femur, tibia, patella) tissue.

[0071] In various embodiments of the present invention, accelerometers are disposed on the tibial component, femoral component, patellar prosthesis, and / or disposed in the bone bonding agent at a density greater than one, two, three, four, five, six, seven, eight, nine, or ten per square centimeter or per cubic centimeter.

[0072] Accelerometers offer the benefit of detecting acceleration, vibration, shock, tilt, and rotation of multiple components. Accelerometers enable the measurement of the prosthesis 10's performance under various conditions and over long periods of time.

[0073] During knee replacement surgery, before surgical closure, the prosthetic joint is moved through its full range of motion and stability tests are performed to assess prosthetic function and mobility. At this time, accelerometer 27 provides the surgeon with a precise, numerical, and quantitative range of motion data; this data can be compared to expected values ​​to assess the effectiveness of the implantation surgery and can be used as a benchmark for comparison with postoperative functional values. Any abnormalities in vibration (indicating insufficient fixation of the prosthesis in the surrounding bone), tilt (indicating improper alignment and / or track movement of the tibiofemoral and patellofemoral joints), rotation (indicating displacement or subluxation), and / or range of motion can be addressed at this time, allowing the surgeon to make intraoperative adjustments. Shortly after the knee has been replaced, the leg will be moved postoperatively, first passively and then actively; shortly after recovery from surgery, the patient will begin to gradually bear weight on the joint. Accelerometer 27 measures the knee joint's movement and track movement during motion, including during forward swinging of the leg, impact with the ground, standing, leaving the ground, and walking when the body is propelled forward. In addition, accelerometers can measure the impact of the foot striking the ground, the effects of forces transmitted through the tibia to the knee joint, and any vibrations, shocks, or rotations that may occur at different locations within the prosthesis 10. As the patient's range of motion improves post-surgery, the acceleration experienced at different locations within the prosthetic knee joint can be monitored. It will be expected that as the patient recovers from surgery, the level of activity will gradually increase, walking will improve and increase, the stride will become faster (and smoother), and furthermore, the stride length will be greater. The effects of exercise and various activities can be monitored using multiple accelerometers 27 and compared with the patient's subjective feelings to determine which daily activities improve (or hinder) post-operative recovery and rehabilitation.

[0074] exist Figure 8 In another embodiment shown, one or more position sensors 28 are disposed throughout the implant, including position sensors 28A distributed on and within the femoral condyle prosthesis, 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 patellar prosthesis (patellar "button"). In some embodiments, the position sensors are located on / within the prosthesis itself (tibial portion, femoral portion, and patellar portion), while in some other embodiments, the position sensors are included on / within the osteosynthesis (if present) used to secure the prosthesis to the surrounding bone, and in still other embodiments, the position sensors are included on / within both the prosthesis components and the osteosynthesis (PMMA).

[0075] In various embodiments, the position sensor can be positioned in a variety of different patterns based on its contact location relative to the surrounding bones (femur, tibia, and / or patella), the surrounding bone bonding agent (if present), the joint interfaces (tibiofemoral and patellofemoral joints) between different prosthetic components, and / or between sub-parts of the components (e.g., between the tibial plate and tibial liner). For example, the position sensor can be arranged in an X-pattern, arranged as an ellipse or concentric ring around multiple components, arranged within multiple components, or arranged in a variety of other patterns to acquire precise data experienced by the prosthetic components, the surrounding bone bonding agent (if present), and (by extension) the surrounding bone (femur, tibia, patella) tissue.

[0076] In various embodiments of the invention, position sensors 28 are disposed on the tibial component, femoral component, patellar prosthesis, and / or disposed in the bone bonding agent at a density greater than one, two, three, four, five, six, seven, eight, nine, or ten per square centimeter or per cubic centimeter.

[0077] Position sensor 28, as described herein, can be used to provide precise positional data (intraoperative and postoperative) (including measurements of flexion and extension movements) to improve the accuracy of physical examinations by providing three-dimensional data of the implant, to detect complete and partial displacement (subluxation) of the tibiofemoral (knee) joint and / or patellar-femoral joint, and to determine appropriate orbital movement of the knee joint and patella.

[0078] exist Figure 9 In another embodiment shown, one or more contact or pressure sensors 22 are disposed throughout the implant, including contact or pressure sensors 22A distributed on and within the femoral condyle articular surface (at multiple depths), contact or pressure sensors 22B distributed on and within the tibial joint liner (at multiple depths), and contact or pressure sensors 27C distributed on and within the patellar joint prosthesis (patellar "button") (at multiple depths).

[0079] These sensors can also be used to detect progressive erosion of multiple articular surfaces. Sensor 22 can be positioned at progressively deeper depths within the articular surface material of the tibia, femur, and patella. These sensors can also be activated upon exposure (or when the overlying surface is worn away) to indicate the extent and depth of surface damage.

[0080] Such sensors can be used to estimate the actual remaining lifespan of implants, as well as to compare the performance and design of different materials and implants.

[0081] B. Using a knee prosthesis, medical device, or kit to deliver one or more therapeutic agents.

[0082] As noted above, the present invention also provides knee prostheses, medical devices, and kits that include one or more sensors and can be used to release a therapeutic agent (e.g., a drug) to a desired location within the body. For example, anti-restenosis drugs (e.g., paclitaxel, rapamycin, or analogues or derivatives thereof) can be administered via a 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 used to determine the proper placement of the desired drug and the amount of drug released at the desired location.

[0083] In other embodiments of the invention, a variety of additional therapeutic agents may be delivered (e.g., to prevent or treat an infection or to treat another disease state), including, for example: cyclophosphamide (e.g., gentamicin, topromycin, doxorubicin, and mitoxantrone); fluorouracil (e.g., 5-FU); folic acid antagonists (e.g., methotrexate); podophyllotoxin (e.g., etoposide); camptothecin; hydroxyurea; and platinum compounds (e.g., cisplatin) (see, for example, U.S. Patent No. 8,372,420, the contents of which are incorporated herein by reference in their entirety). Other therapeutic agents include beta-lactam antibiotics (e.g., penicillins, cephalosporins, carbapenems, and carbapenems); aminoglycosides (e.g., sulfanilamides, quinolones, and oxazolidinones); glycopeptides (e.g., vancomycin); lincosamide antibiotics (e.g., chlordeoxylincomycin); lipopeptides; macrolides (e.g., azithromycin); lactams; furans; polypeptides (e.g., bacitracin); and tetracyclines.

[0084] C. Use knee prostheses, medical devices, or kits with sensors to measure implant deterioration or wear.

[0085] As noted above, in various aspects of the present invention, knee prostheses, medical devices, and kits can detect and assess the deterioration of implants. For example, in one embodiment of the invention, a method for assessing the deterioration of a knee replacement, medical device, or kit is provided, comprising the steps of: a) providing a knee replacement, medical device, or kit having sensors as described herein to a subject, and b) detecting changes in the sensors and thus determining the deterioration of the knee replacement, medical device, or kit. In several embodiments, the sensors (multiple sensors) can detect one or more physiological and / or positional parameters. In another embodiment, one or more sensors can detect contact, fluid flow, pressure, and / or temperature. In yet another embodiment, the sensors can detect location within the subject.

[0086] When a knee prosthesis deteriorates or becomes damaged, sensors can detect changes that allow for the determination of damage and / or deterioration. For example, once deteriorated, a sensor previously embedded in the polymer portion of the device can be exposed to fluid forces and pressures that were not previously present. If the sensor is washed away, it can move within the synovial cavity (i.e., away from its previous implantation location). Therefore, in a preferred embodiment of the invention, deterioration can be detected over a period of time.

[0087] D. Methods for monitoring infections within knee prostheses, medical devices, and kits.

[0088] In other embodiments, the knee prosthesis, medical device, and kit are configured to include one or more temperature and / or metabolic sensors. Such a knee prosthesis, medical device, or kit can be used to measure the temperature of the knee prosthesis, medical device, or kit, as well as the temperature of human tissue adjacent to the knee prosthesis, medical device, or kit. Methods are also provided for monitoring temperature changes over time to identify and / or provide alerts (e.g., alerting patients and / or healthcare providers) that an infection may be imminent.

[0089] In some embodiments of the invention, metabolic and physical sensors may also be incorporated on or within all or part of the knee prosthesis, medical device, or kit to monitor for 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 tissues, may become infected; typically from bacteria residing on the patient's own skin that contaminate the surgical area (typically Staphylococcus aureus or Staphylococcus epidermidis). Sensors such as temperature sensors (detecting increases in temperature), pH sensors (detecting decreases in pH), and other metabolic sensors can be used to indicate the presence of infection on or around the implant. For example, a temperature sensor may be included within one or more components of the knee prosthesis, medical device, or kit to allow for early detection of infection, which may allow for preemptive treatment with antibiotics or surgical drainage and eliminate the need for surgical removal of the knee prosthesis, medical device, or kit.

[0090] Therefore, in one embodiment of the invention, a method for determining an infection associated with a knee prosthesis, medical device, or kit is provided, comprising the steps of: a) providing a knee prosthesis, medical device, or kit as described herein to a subject, wherein the knee prosthesis, medical device, or kit includes at least one temperature sensor and / or metabolic sensor; and b) detecting changes in the aforementioned temperature sensor and / or metabolic sensor, thereby determining the presence of an infection. In various embodiments of the invention, the detection step may be a series of detections over time, and changes in the sensors are used to assess the presence or development of an infection. In another embodiment, a change in temperature of 0.5%, 1.0%, or 1.5% or a 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) may indicate the presence (or an developing infection).

[0091] In several embodiments of the invention, antibiotics can be delivered to prevent, control, or treat an infection after it has been detected. Representative examples of suitable antibiotics are well known and have been described in Part B above (“therapeutic agents”).

[0092] E. Other uses of knee prostheses, medical devices, and kits, including sensors, in healthcare.

[0093] Postoperative progress can be monitored (through comparisons between days, weeks, etc.), and the information is then compiled and transmitted to the patient and attending physician to allow recovery to follow a sequence and be compared to desired (typical population) standards. In some implementations, the wearable device selectively or randomly queries sensors and acquires and / or stores the collected sensor data. This data can then be downloaded to another system or device (described in more detail below).

[0094] Integrating data from sensors described herein (e.g., contact sensors, position sensors, strain gauges, and / or accelerometers) using simple, widely available, and commercially available analytical techniques (e.g., pedometers and GPS capabilities) allows for the further acquisition of clinically important data, such as, but not limited to: the extent of patient walking (time, distance, steps, speed, cadence), patient activity level (activity frequency, duration, intensity), exercise endurance (work, calories, power, training effect), range of motion (described below), and prosthesis performance under various “real-world” conditions. It is difficult to overstate the value of this information in allowing for better management of patient recovery. The attending physician (or physical therapist, rehabilitation specialist) only discovers a patient's condition during routine visits; the extent of a patient's function at the accurate assessment stage can be influenced by a multitude of irrelevant 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 (pain medication, anti-inflammatory drugs), recent activity and exercise levels, patient strength, mental state, language impairment, the nature of their doctor-patient relationship, and even the patient's ability to accurately describe their symptoms, to name a few. Continuous monitoring and data collection allow patients and physicians to objectively monitor progress by providing objective information about the patient's function in many situations and settings, assess how performance is affected by various interventions (pain control, exercise, physical therapy, anti-inflammatory drugs, rest, etc.), and compare rehabilitation progress relative to previous function and expected future function. When both physicians and patients benefit from observing the impact of various treatment modalities on patient recovery, activity, function, and overall performance, better treatment decisions and better patient adherence can be expected.

[0095] Sensors used for contact, strain, accelerometer, and position detection can be of an acceptable type from those generally available sensors (see, for example, U.S. Patents 7,450,332, 7,463,997, and 7,924,267, which describe a variety of such sensors, including MEMS sensors that can be used as strain gauges, accelerometers, and many other sensing functions). The specific sensor described in U.S. Patent 7,450,332 (which detects the free fall of an object and the motion of an object relative to a gravitational field) has a particular advantage in that it can detect and store the full force and activity applied to the leg during passive and active leg movements, and when the leg swings between steps (before, after, and during impact with the ground).

[0096] As an example of the above content Figure 4The use of sensors during a patient's physical examination is illustrated, along with the different types of data that can be obtained from sensors that have been implanted according to the teachings herein. Sensors provide assessment data regarding the range of motion (ROM) of the knee. Currently, ROM is typically measured clinically by the physician passively moving the knee joint through its full range of motion during the physical examination and recording the results (degrees of flexion, extension, abduction, adduction, external rotation, internal rotation, and flexion-rotation). Motion sensors and accelerometers can be used to accurately determine the entire ROM of the prosthetic knee joint during intraoperative procedures (if surgical adjustments are needed), postoperative physical examinations, and normal daily activities between visits. Figure 4 As shown in the image above, a key factor in knee health is the angle X that a patient can achieve at various times during physical therapy after surgery. As angle X decreases, the physician can be confident that joint function is improving. By tracking angle X over time, physical therapists can monitor patient progress, assess whether scar tissue formation, subluxation, or other pathologies limit / affect the knee's ROM, and modify / implement treatment as needed. Using sensors installed as shown in this article, physical therapists or physicians do not need to guess the achieved angle; instead, if the leg is positioned close to the readout computer, the precise angle is known at the moment of clinical joint assessment. On the other hand, if X does not continue to decrease but remains large (or increases), the physical therapist or physician can be alerted to problems regarding the patient's postoperative rehabilitation or delayed recovery, and can investigate and / or take action sooner rather than later. Similarly, Figure 4 The following embodiment, illustrated in the figure below, shows measurements that can be taken when the user holds their leg at an angle Y of exactly 90° as shown. With the leg securely held at 90°, data can be collected from various sensors throughout the leg to determine strain, contact position, acceleration, and other data. The position sensors used herein remind the patient to keep their leg at exactly 90°, allowing for precise data acquisition when data is collected at different times over several months of patient monitoring. Although flexion and extension movements are shown in the accompanying figures, it will be apparent to those skilled in the art that data regarding medial-lateral joint stability and anterior-posterior stability, subluxation (if present), and the orbital movement of the knee and patella can also be collected. Additionally, ROM can be monitored between patient visits by interpreting the ROM generated from the patient's daily movements at home.

[0097] As mentioned above, in other aspects of the invention, a method for imaging a knee replacement or medical device as provided herein is provided, comprising the steps of: (a) detecting the position of one or more sensors in the knee replacement or medical device; and (b) visually displaying the position of the one or more sensors to generate an image of the knee replacement or medical device. In several embodiments, the detection step may be performed over time, and the visual display may show positional movement over time. In some preferred embodiments, the displayed image is a three-dimensional image. In other embodiments, the imaging technique may be used postoperatively to examine the knee replacement or medical device, and / or to compare the operation and / or movement of the device over time.

[0098] Specific exemplary implementations will now be described in more detail. One particular benefit is the real-time and in-situ monitoring of patient recovery and the knee prosthesis 10. The sensors described herein continuously acquire data during normal daily activities and even at night (if desired). That is, specific measurements will be taken at fixed intervals over long periods of time to periodically measure, acquire, and store strain. For example, contact sensors may acquire and report data every 10 seconds, every minute, or once a day. Other sensors will acquire data more frequently, such as several times per second. For example, acceleration data and position data can be acquired and stored several times per second. Other types of data may only need to be acquired by minutes or hours. Still other sensors may acquire data only when the patient signals (via an external signal / triggering device), as part of an "event log," i.e., when the patient experiences a specific event (e.g., pain, injury, instability, etc.), and the signaling device acquires a reading at that time to allow subjective / symptom data to be compared with objective / sensor data in an effort to better understand the underlying causes or triggers of the patient's symptoms. Because the tibial stem includes a large internal section, which can be a hollow or solid metal rod, this internal structure has ample space to house one or more processor circuits, a CPU, memory chips, and other circuitry, as well as antennas for transmitting and receiving data. The processor can be programmed to acquire data from various sensors according to any desired schedule set by the medical technician. All activities can be continuously monitored post-operatively, and data can be acquired and stored in a memory located within the implant.

[0099] Patients typically undergo regular medical checkups. When a patient visits the doctor's office for a checkup, the doctor will place a reading device close to the prosthesis 10 (in this example, a knee replacement) to transmit data from the internal circuitry of the implant to a database in the doctor's office. 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 data transmission are provided in the published patent applications and patents described herein. Data collected based on the patient's movement and leg use over previous weeks or even months is transmitted within minutes from a storage device located in the implant to the doctor's computer or wireless device. The computer then analyzes the data to look for anomalies, unexpected changes over time, positive or negative trends, and other indicators that may indicate the patient's health and the operability of the prosthesis. Furthermore, the doctor can collect recorded data detailing the full impact on the joint, including the magnitude and direction of acceleration. If the doctor identifies a high-acceleration event, such as a patient fall or other physical movement or exercise, the doctor can be prompted to inquire about any problems the patient may have had during that fall, or, alternatively, to warn the patient against overly strenuous movement that could damage the knee implant. For example, if a patient decides to ski or jog, the doctor will be able to monitor the effects of the activity on the prosthesis 10, including acceleration and strain during the event itself. The doctor can then examine the prosthesis's health hours or days after the event and compare it to pre-event data to determine if any particular event caused long-term damage (such as prosthesis separation from surrounding bone tissue or joint subluxation), or whether the aforementioned activity subjected the prosthesis to stress / strain / impact forces exceeding the manufacturer's performance specifications for that particular artificial joint. Data from strain gauges, contact sensors, surface wear sensors, or other sensors that may be present can be collected and compared with the prosthesis's current and long-term performance.

[0100] In an alternative approach, patients could also have such a reading device at home, which periodically checks data from the prosthesis, such as daily or weekly. As mentioned above, patients can also “trigger” the device reading (via an external signal / trigger) as part of an “event log,” allowing them to track their own recovery and observe the positive (and negative) effects of various lifestyle choices on their health and recovery, which can be expected to improve compliance and patient outcomes. Furthermore, patients’ experiences can be shared online with other patients to compare their progress relative to expected “standards” of function and recovery, and to alert patients to signs and symptoms that should draw their physician’s attention. The performance of different implants can be compared across different patients (different genders, weights, exercise levels, etc.) to help manufacturers design better prostheses and to help orthopedic surgeons select the right prosthesis for specific patient types. Payers, patients, manufacturers, and physicians all benefit from this comparative information collection. Finally, data accumulated at home can be collected and transmitted via the internet to the physician’s office for analysis, potentially eliminating unnecessary visits in some cases and facilitating immediate medical follow-up for others.

[0101] F. Electricity generation

[0102] In some aspects of the invention, a small power generation unit may be disposed along the outer surface of the implant or alternatively along the inner surface. Specifically, each time a user takes a step, there is a release and increase of pressure within the internal structure of the implant. Using a suitable piezoelectric material or a micro-generator, a small amount of electricity can be generated with each step. The electricity can be stored in a capacitor also mounted within the implant. The electricity can then be used to power sensors located at multiple locations within the prosthesis.

[0103] Various techniques for extracting electricity from small mechanical movements or vibrations have been described. See, for example, the article entitled “Piezoelectric Power Scavenging of Mechanical Vibration Energy” by UK Singh et al., published at the Australian Mining Technology Conference, October 2-4, 2007, pp. 111-118. This article provides examples of different types of power harvesters that can generate electricity from very small movements and store that electricity for later use. The aforementioned articles also describe implementations in which pressure is applied to or released onto a specific structure, thereby generating electricity simply by applying high voltage without movement. As described in the embodiments herein, when a patient places their weight on their legs during a step, a force is applied to the internal structure of the implant, and this force can generate enough electricity to operate all the sensors described herein. Other mechanisms that can generate electricity from very small amounts of repetitive movement are described in U.S. Patent Application No. 2010 / 0164705, published July 1, 2010. This patent application describes a technique that allows energy to be harvested from the rotation of a tire, which can then be used to power multiple different sensors, and subsequently, at selected time periods, selected sensors can output the acquired data to a central acquisition area. Other sensors of this type are described in published U.S. Patent No. 7,603,894, entitled "Self-Powered Tire Monitoring System".

[0104] In a preferred embodiment, the power generation system is inactive and relies solely on the pressure applied during stepping and the release of that pressure upon completion of the step, along with the free leg swing for the next step. Because there is no movement, the implant is not perceived by minor changes in its position or length during stepping. Instead, the length remains constant and electricity is generated via a piezoelectric structure or an internal suspension structure that does not form part of the implant's support structure.

[0105] After electricity is generated by one or more generators, it is transmitted to any of the various sensors described herein. For example, electricity may be transmitted to contact sensor 22, strain gauge 26, accelerometer 27, or position sensor 28. Electricity may also be transmitted to other sensors described herein. Power transmission can be performed using any acceptable technique. For example, if a sensor is physically coupled to an implant, wires may be routed from the generator to that particular sensor. Alternatively, electricity may be transmitted wirelessly, in a manner similar to that of a wireless smart card receiving power from an adjacent power source using suitable transmitting and receiving antennas. Such methods of power transmission and reception are also described in publications and patent applications, as well as in previously described published U.S. patents, the entire contents of which are incorporated herein by reference.

[0106] G. Medical imaging and self-diagnosis of knee replacement components; predictive analytics and predictive repair.

[0107] This invention provides knee replacements capable of imaging using sensors in a wide variety of situations. For example, in various aspects of the invention, a method is provided for imaging a knee replacement (or a portion thereof, such as a medical device or kit as described herein) or a component comprising a knee replacement, medical device, or kit, using sensors. This method includes the step of detecting changes in sensors over time within, on, and in the knee replacement, medical device, or kit, and wherein the knee replacement, medical device, or kit includes sensors present at a density greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or 10 sensors per square centimeter. In other aspects, the knee replacement, medical device, or kit includes sensors present at a density greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or 10 sensors per cubic centimeter. Sensors are present at densities of 5, 6, 7, 8, 9, 10, or 10 sensors. In any of these embodiments, fewer than 50, 75, 100, or 100 sensors may be present per square centimeter or per cubic centimeter. In many embodiments, at least one or more of the sensors may be randomly arranged or located at one or more specific locations within a knee replacement, medical device, or kit as described herein. As mentioned above, a wide variety of sensors can be utilized herein, including, for example, contact sensors, strain gauge sensors, pressure sensors, fluid 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.

[0108] For example, knee replacements, medical devices, or kits incorporating the sensors described herein can be used to image the knee anatomy by detecting positional movement. The sensors used may also include accelerometers and motion sensors to detect movement of the knee replacement due to various physical changes. Changes in the position of the accelerometer and / or motion sensor over time can be used as measurements of the knee replacement's position over time. This change in position can serve as a proxy marker for knee anatomy—that is, this change in position can form an "image" of the knee replacement to provide information about changes in the knee replacement's size, shape, and position, and / or about knee replacement movement / migration. For example, loosening of the knee prosthesis can lead to undesirable movement of the prosthesis relative to the bone into which it is implanted during exercise and weight-bearing. By utilizing the sensors of this invention, the location and extent of undesirable movement present during different movements and activities can be determined. Similarly, monitoring changes in the joint space over time (i.e., changes in the space separating the femoral component from the tibia) can be used as an indicator of erosion and wear on the articular surfaces (femoral side and / or tibial side). Ultimately, tracking the movement of sensors throughout their full range of motion provides a dynamic “image” of the joint; this allows clinicians to monitor the improvement and decline of joint (and surrounding tissue) function over time.

[0109] H. Methods for monitoring components including knee replacements

[0110] As described above, the present invention also provides a method for monitoring one or more of the knee replacement components provided herein. For example, Figure 10 A monitoring system is shown that can be used with any of the knee replacements 10 of the type shown in the above figures. The monitoring system includes sensors (e.g., 22, 26, 27 and / or 28), an interrogation module 124, and a control unit 126. The sensors (e.g., 22, 26, 27 and / or 28) can be passive, wireless types capable of operating based on power received from a wireless power source. Such sensors are well known and widely available in the art. This type of pressure sensor can be a MEMS pressure sensor, such as Part No. LPS331AP publicly available from STMicroelectronics. MEMS pressure sensors are known to operate with very low power and are suitable for long-term power-free and idle states. MEMS pressure sensors can be wirelessly powered using RF signals and based on power wirelessly received on the RF signals, perform pressure sensing, and subsequently output sensed data.

[0111] In one embodiment, a power generation system (as described above) is provided, which can be used to power the sensors described herein. During operation, as... Figure 10As shown, the interrogation module 124 outputs signal 128. Signal 128 is a wireless signal (typically in the RF band) that includes power for the sensors (e.g., 22, 26, 27, and / or 28) and an interrogation request requesting the sensors to perform sensing. When interrogated via signal 128, the sensors (e.g., 22, 26, 27, and / or 28) are powered on and store sufficient power in an on-chip capacitor to sustain operation during sensing and data reporting. Such power receiving circuitry and storage in the on-chip capacitor are well known in the art and therefore need not be shown in detail. Appropriate sensing is performed by the sensors (e.g., 22, 26, 27, and / or 28), and data is subsequently output from the sensors back to the interrogation module 124 via signal 130, where data is received at the input port of the interrogation module.

[0112] According to one embodiment, sufficient signal strength is provided in the initial signal 128 to power the sensor and perform sensing operations, and to output the signal back to the interrogation module 124. In other embodiments, two or more signals 128 are transmitted, each providing additional power to the sensor to allow it to complete sensing operations and subsequently providing sufficient power to transmit data back to the interrogation module 124 via signal channel 130. For example, signals 128 may be transmitted continuously, with a sensing request component in the first portion of the signal, and then a stable signal or pulse may continue to power the sensor to operate. When the sensor is ready to output data, it sends a signal to alert the interrogation module 124 that data is imminent, and signals 128 may be turned off to avoid interference. Optionally, the integrated signal 128 may be at a first frequency while the output signal 130 is at a second frequency that is sufficiently separated to prevent interference between them. In a preferred embodiment, signals 128 and 130 are at the same frequency so that the same antenna on the sensor can receive signal 128 and transmit signal 130.

[0113] The interrogation signal 128 may include data for selecting a specific sensor on the knee replacement. For example, signal 128 may simultaneously power on all sensors on the knee replacement and subsequently send requests for data from each sensor at different selected times, such that a single interrogation signal 128, provided for a set time (e.g., 1-2 seconds), causes each sensor on the knee replacement to acquire data during this time period, and then, at the end of the time period, to report the data on the corresponding signal 130 at different times within the next 0.5 to 2 seconds, thus enabling data acquisition from all sensors 22 using a single interrogation signal 128.

[0114] The inquiry module 124 operates under the control of a control unit 126, which includes a microprocessor for the controller, memory, I / O circuitry for interfacing with the inquiry module, and a power supply. The control unit can output data to a computer or other device for display to the physician and for the physician's use in treating the patient.

[0115] Figure 11 Operation according to a preferred embodiment is illustrated within the object. The object has an outer skin 132. (As shown) Figure 11 As shown, the interrogation module 124 and control unit 126 are positioned outside the skin 132 of the object. The interrogation signal 128 uses a wireless RF signal transmitted through the skin of the object, and data is received back to the interrogation module 124 from sensors (e.g., 22, 26, 27, and / or 28) on the wireless RF signal 130. While the wireless signal can be in any frequency range, the RF range is preferred. Frequencies in the VLF to LF range between 3 and 1300 kHz are preferred to allow the signal to be carried to sufficient depth within the body with low power, but 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; therefore, low-frequency RF signals are acceptable. This also avoids competition with other wireless signal generators (such as Bluetooth, mobile phones, etc.) and unintentional activation by them.

[0116] I. Acquisition, transmission, analysis, and distribution of data from components including knee replacement devices.

[0117] Figure 12 An embodiment of an information and communication technology (ICT) system 800 arranged to process sensor data (e.g., data from sensors (e.g., 22, 26, 27, and / or 28) in any of the accompanying drawings provided herein) is illustrated. Figure 12 In this context, ICT system 800 is represented as including computing devices that communicate via network 804; however, in other embodiments, computing devices may communicate directly with each other or through other intermediary devices, and in some cases, computing devices may not communicate at all. Figure 12 The computing device includes a computing server 802, a control unit 126, an interrogation unit 124, and other devices not shown for the purpose of simplicity.

[0118] exist Figure 12 In this process, one or more sensors (e.g., 22, 26, 27 and / or 28) communicate with the interrogation module 124. Figure 12 The interrogation module 124 is managed by the control unit 126; however, in other cases, the interrogation module 124 operates autonomously and transmits information to or from the sensor 22. One or both of the interrogation module 124 and the control unit 126 can communicate with the computing server 802.

[0119] In some embodiments, the interrogation module and / or control unit may be a wearable device located on the object. This wearable device (e.g., a watch, glasses, wristband, or other device that the object can carry or wear) may interrogate sensors, collect data, and forward the data to one or more networks (804) at set (or random) time intervals. Furthermore, the wearable device may automatically collect data, which may also be transmitted to a network. Representative examples of data that may be collected include location (e.g., GPS), body temperature or skin temperature, and other physiological data (e.g., pulse). In yet other embodiments, the wearable device may directly notify the object of any of a number of specified conditions, including but not limited to possible or actual device malfunction.

[0120] The information communicated between the interrogation module 124 and the sensors (22, 26, 27 and / or 28) is useful for many of the purposes described herein. In some cases, for example, sensor data information is collected and analyzed specifically for the health of a single object. In other cases, sensor data is collected and transmitted to another computing device for combination with other data (e.g., sensor data from 22 may be collected and combined with data collected from a wearable device (e.g., in some embodiments, a device that may include GPS data, etc.)).

[0121] Figure 12 Aspects of computing server 802 as a server cooperative group are shown, wherein computing server 802 includes computing servers 802a, 802b and one or more other servers 802n. It should be understood that computing server 802 may include any number of computing servers operating individually or jointly for the benefit of users of the computing server.

[0122] In some implementations, computing server 802 is arranged as a cloud computing device created in one or more geographical locations (such as the United States and Canada). This cloud computing device may be created as a Microsoft Azure cloud computing device or some other virtually accessible remote computing service.

[0123] The interrogation module 124 and the control unit 126 are optionally shown to communicate with the computing server 802. Sensor data is transmitted to the computing server 802 (and additionally or optionally, from the computing server 802) via the interrogation module 124 or the control unit 126.

[0124] Network 804 includes some or all of cellular communication networks, traditional cable networks, satellite networks, fiber optic networks, 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 communication hardware and software that work cooperatively to allow users of computing devices to view and interact with other computing devices.

[0125] The computing server 802 includes a central processing unit (CPU), a digital signal processing unit (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 interconnected via one or more buses 816, which facilitate the transmission and control of information within and through the computing server 802. The communication module 810 is configured to exchange information between the computing server 802 and other computing devices (e.g., computing servers 802a, 802b, 802n, control unit 126, interrogation unit 124, etc.). The I / O module 812 is configured to receive input from devices such as a keyboard, computer mouse, trackball, etc. The I / O module 812 is configured to provide output to devices such as a display, recorder, LED, audio device, etc.

[0126] Storage module 814 may include one or more types of storage media. For example, Figure 12 The storage module 814 includes random access memory (RAM) 818, read-only memory (ROM) 810, hard disk storage 822, optical storage 8124, and other types of storage media 8126. In some embodiments, one or more storage devices of the storage module 814 are configured with one or more database structures. These database structures can be used to store data acquired from the sensor 22.

[0127] In some embodiments, storage module 814 may also include a non-transitory computer-readable medium (CRM) organized in one or more portions of the storage. The CRM is configured to store computational instructions executable by CPU 808. These computational instructions may be stored as one or more files, and each file may include one or more computer programs. The computer programs may be standalone programs or part of a larger computer program. Alternatively or additionally, each file may include data or other computational support material for an application that directs the acquisition, analysis, processing, and / or distribution of data from sensors (e.g., knee replacement sensors). Sensor data applications typically execute a set of instructions stored on the computer-readable medium.

[0128] It should be understood that the computing servers shown in the figures and described herein are illustrative only and are not intended to limit the scope of the invention. Computing server 802 may connect to other devices not shown, including via one or more networks (such as the Internet) or via a network incorporated into network 804. More generally, a computing system or device (e.g., a “client” or “server”) or any part thereof may include any combination of hardware that can interact and perform functions of the type described (optionally when programmed or configured with software), including but not limited to desktop or other computers, database servers, network storage devices and other network devices, PDAs, mobile phones, cordless phones, glasses, wristbands, pagers, electronic notebooks, internet-connected appliances, television-based systems (e.g., utilizing set-top boxes and / or personal / digital video recorders), and various other products including suitable inter-communication capabilities. Furthermore, the functionality provided by the system modules shown may be combined in fewer modules or distributed across additional modules in some embodiments. Similarly, in some embodiments, the functionality of some of the modules shown may not be provided and / or other additional functionality may be available.

[0129] Furthermore, although various items are shown to be stored in memory or storage during use, these items or portions thereof may be transferred between memory and other storage devices for storage management and / or data integrity purposes. In at least some embodiments, the illustrated modules and / or systems are software modules / systems comprising software instructions that, when executed by a CPU / DSP808 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 be executed in memory on other devices and communicate with the illustrated computing system / device via inter-computer communication.

[0130] Furthermore, in some embodiments, some or all of the modules and / or systems may be implemented or provided in other ways, such as at least in part in firmware and / or hardware, including, but not limited to, one or more application-specific integrated circuits (ASICs), standard integrated circuits, controllers (e.g., by 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 transient or non-transient computer-readable storage media 814, such as hard disks 822 or flash drives or other non-volatile storage devices 8126, volatile storage devices 818 or non-volatile memory 810, network storage devices, or portable media articles (e.g., DVDs, CDs, optical discs, flash memory devices, etc.) to be read by appropriate input or output systems or via appropriate connections. The system, modules, and data structures can also be transmitted as generated data signals (e.g., as part of a carrier or other analog or digital propagation signal) over various computer-readable transmission media, including wireless-based and wire / cable-based media, in some embodiments. The data signals can take various forms, such as as part of a single or multiplexed analog signal, as multiple discrete digital packets or frames, as discrete or streaming digital bit groups, or in some other form. In other embodiments, such a computer program product can also take other forms. Accordingly, the invention can be implemented using other computer system configurations.

[0131] exist Figure 12 In this process, sensor data from, for example, sensors (e.g., 22, 26, 27, and / or 28) is provided to computing server 802. Generally, sensor data refers to data acquired from a known object and from a known sensor. Sensor data may include additional information or be further associated with additional information, such as USI, UDI, timestamps, location (e.g., GPS) markers, date stamps, and other information. A difference between various sensors is that some sensors may include more or fewer data bits that associate data with a specific source, acquisition device, transmission characteristics, etc.

[0132] In some implementations, sensor data may include sensitive information, such as private health information associated with a specific object. Sensitive information, such as sensor data from sensors (e.g., 22, 26, 27, and / or 28), may include any information that the associated party wishes to be protected from widespread dissemination or that is easily disseminated. Sensitive information may exist in isolation or may be combined with other non-sensitive information. For example, an object's medical information is typically sensitive information. In some cases, the storage and transmission of an object's medical information is protected by government directives (e.g., laws, regulations, etc.), such as the Health Insurance Portability and Accountability Act (KNEEPA).

[0133] As described in this article, "sensitive" information includes completely sensitive information as well as combinations of sensitive and non-sensitive information. Sensitive information can be represented as data files or other formats. As used herein, a data file containing the subject's medical information can be termed "sensitive information." Other information, such as employment information, financial information, identity information, and many other types of information, can also be considered sensitive information.

[0134] Computing systems can represent sensitive information using encoding algorithms (e.g., ASCII), recognized file formats (e.g., PDF), or other formats. Within computing systems, encryption algorithms can be used to protect sensitive information from widespread or easy dissemination.

[0135] Generally, a computing system can store sensitive information as a set of discrete data bits. This set of data bits can be called "plaintext". Furthermore, the computing system can use an encryption algorithm (i.e., a cryptography) to convert the plaintext into a set of data bits in a highly unreadable state (i.e., ciphertext). A computing system with key information used to create the ciphertext can restore the information to a plaintext-readable state. Accordingly, in some cases, sensitive data (e.g., sensor data 806a, 806b) is optionally encrypted before communicating with a computing device.

[0136] In one implementation method Figure 12 The operation of the information and communication technology (ICT) system 800 includes a computer program storing one or more sensor data on a computer-readable transmission medium. This computer program may optionally manage one or more knee replacement sensors implanted in one or more objects and / or receive data from them. The sensor data computer program may be executed in a computing server 802. Alternatively or additionally, the sensor data computer program may be executed in a control unit 126 or an interrogation unit 124.

[0137] In one embodiment, a computer program that manages the acquisition and use of knee replacement sensor data is stored on a non-transitory computer-readable medium in storage module 814. The computer program is configured to identify an object with a wireless knee replacement inserted into their body. The wireless knee replacement may include one or more wireless sensors.

[0138] In some cases, the computer program identifies one object, while in others, it identifies two or more objects. Each object may have one or more wireless knee replacements, and each wireless knee replacement may have one or more wireless sensors of the type described herein.

[0139] The computer program is configured to manage the acquisition of sensor data from the wireless knee replacement device. Sensor data is typically acquired using 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 manages the wireless interrogation unit 124. In still other cases, additional facilities are used to manage the acquisition of sensor data.

[0140] Once sensor data is acquired, it can be further processed. For example, in some cases, sensor data includes sensitive object data, which can be removed or de-associated with the data. Sensor data can be stored separately (e.g., by a unique sensor identification number, device number, etc.) or aggregated with other sensor data by sensor type, timestamp, location marker, date marker, object type, other object characteristics, or in some other way.

[0141] The following pseudocode description is used to generally illustrate an exemplary algorithm, which is executed by a computing server 802, and is generally referred to herein. Figure 12 Describe it as follows:

[0142]

[0143] Those skilled in the art will understand that implementing an apparatus and / or method and / or system, and subsequently integrating such an implemented apparatus and / or method and / or system into a more complex apparatus and / or method and / or system using engineering and / or other methods, is common practice in the art. That is, at least a portion of the apparatus and / or method and / or system described herein can be integrated into other apparatus and / or method and / or system through a reasonable number of experiments. Those skilled in the art will understand that examples of such other apparatus and / or methods and / or systems may include (as appropriate to the context and application) all or part of the following: (a) air transport vehicles (e.g., airplanes, rockets, helicopters, etc.); (b) ground transport vehicles (e.g., cars, trucks, locomotives, tanks, armored personnel carriers, etc.); (c) buildings (e.g., residences, warehouses, offices, etc.); (d) household appliances (e.g., refrigerators, washing machines, dryers, etc.); (e) communication systems (e.g., networked systems, telephone systems, VoIP systems, etc.); (f) business entities (e.g., Internet Service Provider (ISP) entities, such as Comcast Cable, Qwest, Southwestern Bell, etc.); or (g) wired / wireless service entities (e.g., Sprint, Cingular, Nextel, etc.).

[0144] In some cases, the use of a system or method can still occur in a geographically located area, even if a component is located outside that area. For example, in a distributed computing environment, the use of a distributed computing system can still occur in that area, even if a part of the distributed computing system may be located outside the geographically located area (e.g., relays, servers, processors, signal-bearing media, transmitting computers, receiving computers, etc., located outside the geographically located area).

[0145] Even if a component of the system or method is located and / or used outside a certain geographic region, the sale of the system or method may still occur in that region. Furthermore, an implementation of at least a portion of a system for performing a method in one geographic region does not preclude the use of the system in other geographic regions.

[0146] In summary, prosthetic knee replacements utilizing multiple sensors can serve a variety of key clinical functions, such as: safe, accurate, and minimally invasive positioning and setup of the knee replacement; intraoperative and postoperative "real-time" imaging of the knee replacement and surrounding anatomy; the development of knee replacement complications; and the patient's overall health status. Currently, postoperative (hospitalization and discharge) assessments of knee replacement patients are supplemented by medical monitoring using patient history, physical examination, and the use of necessary diagnostic imaging studies. However, much of the patient's recovery period occurs between hospital or office visits, and much data regarding daily function is not captured; furthermore, monitoring patient progress using some diagnostic imaging techniques can be expensive, invasive, and carries its own health risks (e.g., the use of nuclear isotopes or certain dyes). Therefore, it is difficult to accurately measure and track the development of symptom deterioration and assess "real-life" knee replacement performance, especially when it involves patient activity levels, exercise tolerance, and the effectiveness of rehabilitation efforts and medical care.

[0147] Currently, neither doctors nor patients have access to the type of "real-time," continuous, objective knee replacement performance measurements they might desire. The ability to monitor knee replacement function, integrity, anatomy, and physiology in situ provides valuable objective information to doctors during office visits; furthermore, patients can obtain additional readings at home at various times (e.g., when experiencing pain, during exercise, after medication), providing important supplemental clinical information to doctors (and even electronically transmitting data from remote locations to healthcare professionals). From the patient's perspective, the ability to monitor many of these same parameters at home allows them to play a more proactive role in patient care and recovery, providing early warnings or reassurance to seek medical assistance.

[0148] In one alternative implementation, the patient may have a reading device at home that periodically checks data from the knee replacement, such as daily or weekly. In addition to allowing patients to track their own recovery and observe the positive (and negative) effects of various lifestyle choices on their health and recovery, this information access is expected to improve compliance and patient outcomes. For example, in some implementations, the devices and systems provided herein may notify or otherwise inform the patient or a permitted third party of deviations from normal parameters and / or set parameters (e.g., greater than 10%, 20%, 25%, 50%, 70%, and / or 100%). Furthermore, a patient's recovery experience can be shared with other patients via a network to compare their progress relative to a "normal" state of function and recovery, and to alert patients to signs and symptoms that should draw their physician's attention. From a public health perspective, the performance of different knee implants can be compared across different patients (different genders, disease severity, exercise levels, complications such as hypertension and diabetes, smoking status, obesity, etc.) to help manufacturers design better knee implants and to help physicians select the right knee implant for specific patient types. Payers, patients, manufacturers, and doctors can all benefit from the collection of this comparative information. Inferior and dangerous products can be identified and removed from the market, and objective, long-term validity data can be collected and analyzed. Finally, data accumulated at home can be collected and transmitted via the internet to the doctor's office for analysis, potentially eliminating unnecessary visits in some cases and facilitating immediate medical follow-up in others.

[0149] The following are some specific numbered embodiments of the systems and methods disclosed herein. These embodiments are merely exemplary. It should be understood that the invention is not limited to the embodiments set forth herein for illustrative purposes, but should cover all such forms falling within the scope of the above disclosure.

[0150] 1) Knee replacement prostheses, including:

[0151] At least one of the tibial component, the patellar prosthesis, and the femoral component; and

[0152] Multiple sensors are connected to at least one of the tibial component, patellar prosthesis, and femoral component.

[0153] 2) The knee replacement prosthesis as described in Embodiment 1, wherein the plurality of sensors include sensors located on the tibial component.

[0154] 3) The knee replacement prosthesis as described in Embodiment 1, wherein the plurality of sensors include sensors located on the patellar prosthesis.

[0155] 4) The knee replacement prosthesis as described in Embodiment 1, wherein the plurality of sensors include sensors located on the femoral component.

[0156] 5) The knee replacement prosthesis as described in 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.

[0157] 6) A knee replacement prosthesis as described in Embodiment 5, wherein the accelerometer detects acceleration, tilt, vibration, shock and / or rotation.

[0158] 7) The knee replacement prosthesis as described in Embodiment 1, wherein the plurality of sensors include contact sensors disposed on the femoral component.

[0159] 8) The knee replacement prosthesis as described in Embodiment 1, wherein the plurality of sensors include a plurality of contact sensors disposed on the patellar component.

[0160] 9) The knee replacement prosthesis as described in Embodiment 1, wherein the plurality of sensors include a plurality of contact sensors disposed on the tibial component.

[0161] 10) A medical device, including a femoral component of a knee replacement prosthesis and a plurality of sensors connected to said femoral component.

[0162] 11) A medical device, including a patellar prosthesis for knee replacement and a plurality of sensors connected to the patellar prosthesis.

[0163] 12) A medical device, including a tibial component of a knee replacement prosthesis and a plurality of sensors connected to said tibial component.

[0164] 13) The medical device as described in any one of embodiments 10 to 12, wherein the sensor is disposed within and / or on the surface of the medical device.

[0165] 14) The medical device according to 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.

[0166] 15) The medical device of embodiment 14, wherein the accelerometer detects acceleration, tilt, vibration, tremor and / or rotation.

[0167] 16) The knee replacement prosthesis as described in any one of embodiments 1 to 9 or the medical device as described in any one of embodiments 10 to 15, further comprising:

[0168] An electronic processor is disposed on and / or within at least one of the tibial component, patellar prosthesis, and / or femoral component electrically connected to the sensor.

[0169] 17) A knee replacement prosthesis or medical device as described in embodiment 16, wherein the electrical connection is a wireless connection.

[0170] 18) The knee replacement prosthesis or medical device as described in embodiment 17 further includes:

[0171] A memory, connected to an electronic processor and disposed on and / or within at least one of the tibial component, patellar prosthesis, and femoral component.

[0172] 19) A knee replacement prosthesis or medical device as described in any one of embodiments 1 to 18, wherein the sensor is a plurality of sensors disposed on or within the knee replacement at a density greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per square centimeter.

[0173] 20) A knee replacement or medical device as described in any one of embodiments 1 to 19, wherein the sensor is a plurality of sensors disposed on or within the knee replacement at a density greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per cubic centimeter.

[0174] 21) Methods, including:

[0175] Contact data is obtained from contact sensors located at multiple positions between, above, and / or within the patient’s knee replacement prosthesis or medical device, as described in any of embodiments 1 to 20.

[0176] Storing data in a storage device located on or within the knee replacement prosthesis or medical device; and

[0177] Data is transferred from storage to a location outside the knee replacement prosthesis or medical device.

[0178] 22) The method of embodiment 22 further includes:

[0179] Strain data is obtained from strain sensors located at multiple sites on the patient's knee replacement prosthesis or medical device;

[0180] The strain data is stored in a memory located in the knee replacement prosthesis or medical device; and

[0181] Strain data is transferred from memory to memory located outside the knee replacement prosthesis or medical device.

[0182] 23) The method as described in embodiment 22 further includes:

[0183] Contact data is obtained from a contact sensor located in the patient’s knee replacement prosthesis or medical device as described in any of embodiments 1 to 19;

[0184] The contact data is stored in a memory located within the knee replacement prosthesis or medical device; and

[0185] Data is transferred from the memory to a memory located outside the knee replacement prosthesis or medical device.

[0186] 24) Methods, including:

[0187] Acceleration data are obtained from accelerometers located in situ at multiple locations on a knee replacement prosthesis or medical device, as described in any of embodiments 1 to 19, within the patient's knee.

[0188] Accelerometer data is stored in a memory located within the knee replacement prosthesis or medical device; and

[0189] Acceleration data is transferred from the memory in the knee replacement prosthesis or medical device to a memory located outside the knee replacement prosthesis or medical device.

[0190] 25) A kit comprising a knee replacement prosthesis or medical device as described in any one of embodiments 1 to 19, the kit further comprising:

[0191] Bone bonding agent and / or bone screw including one or more sensors.

[0192] 26) The kit as described in 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.

[0193] 27) The kit as described in embodiment 25 or 26, wherein the sensors are arranged on the prosthesis or medical device at a density of more than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per square centimeter.

[0194] 28) A knee replacement, medical device, or kit as described in any of embodiments 1-20 or 25-27, wherein one or more sensors are randomly disposed within the knee replacement, medical device, or kit. In other embodiments, the sensors may be disposed at specific locations within the knee replacement, medical device, or kit.

[0195] 29) A method for detecting and / or recording events in a subject using a knee replacement or medical device as provided in any of embodiments 1 to 28, comprising querying and recording the activity of one or more sensors within the knee replacement or medical device at a desired time point.

[0196] 30) The method as described in embodiment 29, wherein the inquiry step is performed by an object having an implanted knee replacement or medical device.

[0197] 31) The method as described in embodiment 30, wherein the steps recorded above are performed on a wearable device.

[0198] 32) The method of any one of embodiments 29 to 31, wherein the above-mentioned record is provided to the healthcare provider.

[0199] 33) A method for imaging a knee replacement, medical device, or kit as described in any one of embodiments 1 to 20 or claims 25 to 27, comprising:

[0200] (a) Detecting the location of one or more sensors in a knee replacement, medical device, or kit as described in any of embodiments 1 to 20 or 25 to 27; and

[0201] (b) Visually display the position of the one or more sensors to generate an image of the knee replacement or medical device.

[0202] 34) The method as described in embodiment 33, wherein the detection step occurs over time.

[0203] 35) The method as described in embodiment 34, wherein the visual display shows the position change of the sensor over time.

[0204] 36) The method of any one of embodiments 33 to 35, wherein the visual display is a three-dimensional image of the knee replacement or medical device.

[0205] 37) A method for inserting a knee replacement, medical device, or kit as described in any one of embodiments 1 to 20 or 25 to 27, comprising:

[0206] (a) Inserting the medical device as described in any one of embodiments 1 to 20 or 25 to 27 into the object; and

[0207] (b) Positioning imaging of the medical device according to any one of embodiments 33 to 36.

[0208] 38) A method for examining a knee replacement, medical device, or kit previously inserted into a patient as described in any one of embodiments 1 to 20 or 25 to 27, comprising the step of imaging the knee replacement or medical device according to any one of embodiments 33 to 36.

[0209] 39) Methods for monitoring knee replacements, medical devices, or kits within the subject, including:

[0210] Transmit wireless electrical signals from a location outside the body to a location inside the body;

[0211] Receive signals at a sensor located inside the body on a knee replacement, medical device, or kit as described in any of embodiments 1 to 20 or 25 to 27;

[0212] The received signal is used to power the sensor;

[0213] Sensing data at the sensor; and

[0214] The sensor outputs the sensed data to a receiving unit located outside the body.

[0215] 40) The method as described in embodiment 39, wherein the receiving unit is a watch, wristband, cellular phone, or glasses.

[0216] 41) The method as described in embodiment 39 or 40, wherein the receiving unit is located in the target's residence or office.

[0217] 42) The method of any one of embodiments 39 to 41, wherein the sensed data is provided to a healthcare provider.

[0218] 43) The method as described in any of embodiments 39 to 42, wherein the sensed data is published to one or more websites.

[0219] 44) A non-transitory computer-readable storage medium, the contents of which configure a computing system to perform a method, the method comprising:

[0220] The identified object has at least one wireless knee replacement, medical device, or kit as described in any one of embodiments 1 to 20 or 25 to 27, each wireless knee replacement, medical device, or kit having one or more wireless sensors.

[0221] Manage the wireless interrogation unit to acquire sensor data from at least one of one or more corresponding wireless sensors; and

[0222] Receive the collected sensor data.

[0223] 45) A non-transitory computer-readable storage medium as described in embodiment 44, the contents of which configure a computing system to execute a method, the method further comprising:

[0224] Identify multiple objects, each of which has at least one wireless knee replacement, medical device, or kit, and each wireless knee replacement, medical device, or kit has one or more wireless sensors;

[0225] The wireless interrogation unit associated with each identified object acquires sensor data from at least one of the corresponding one or more wireless sensors;

[0226] Receive and collect sensor data; and

[0227] Total sensor data collected.

[0228] 46) A non-transitory computer-readable storage medium as described in embodiment 44, the contents of which configure a computing system to execute a method, the method further comprising:

[0229] Remove sensitive object data from the collected sensor data; and

[0230] The aggregated data is analyzed based on the sensor type.

[0231] 47) A non-transitory computer-readable storage medium as described in embodiment 44, the contents of which configure a computing system to execute a method, wherein managing the wireless interrogation unit includes managing a control unit associated with the wireless interrogation unit.

[0232] 48) A non-transitory computer-readable storage medium as described in any one of embodiments 44 to 47, wherein the knee replacement, medical device, or kit is a component as described in any one of embodiments 1 to 20 or 25 to 27.

[0233] 49) The storage medium as described in any one of embodiments 44 to 48, wherein the sensor data collected above is received on a watch, wristband, cellular phone or glasses.

[0234] 50) The storage medium as described in any one of embodiments 44 to 49, wherein the sensor data collected above is received in the object's residence or office.

[0235] 51) The storage medium as described in any one of embodiments 44 to 50, wherein the sensed data collected above is provided to a healthcare provider.

[0236] 52) The storage medium as described in any one of embodiments 44 to 51, wherein the sensed data is published to one or more websites.

[0237] 53) The method as described in any one of embodiments 39 to 43, or the storage medium as described in any one of embodiments 44 to 52, wherein the aforementioned data is analyzed. In some embodiments, the data may be analyzed to assess the range of motion of the object. In other embodiments, the data may be analyzed to assess or detect bone erosion, inflammation, surface wear, and / or deterioration and / or potential damage or destruction of a knee prosthesis, medical device, or kit (or any part thereof).

[0238] 54) The method or storage medium as described in embodiment 53, wherein the data is plotted to enable visualization of changes over time.

[0239] 55) The method or storage medium as described in embodiment 53 or 54, wherein the data is plotted to provide a three-dimensional image.

[0240] 56) Methods for determining the deterioration of knee replacements, medical devices, or kits, including:

[0241] a) Providing the subject with a knee replacement, medical device, or kit as described in any of embodiments 1 to 20 or 25 to 27; and

[0242] b) Detect changes in sensors and thereby determine the deterioration of knee replacements, medical devices, or kits.

[0243] 57) The method as described in embodiment 56, wherein the sensor is capable of detecting one or more physiological parameters and / or positional parameters.

[0244] 58) The method as described in embodiment 56 or 57, wherein the sensor detects contact, fluid flow, pressure and / or temperature.

[0245] 59) The method as described in any of embodiments 56 to 58, wherein the sensor detects a position within the object.

[0246] 60) The method as described in any of embodiments 56 to 59, wherein the sensor moves within the body based on the deterioration of the knee replacement.

[0247] 61) The method as described in any of embodiments 56 to 60, wherein the detection step is a series of detections over time.

[0248] 62) Methods for determining infection associated with a knee replacement, medical device, or kit, including:

[0249] a) Providing a knee replacement, medical device, or kit as described in any one of embodiments 1 to 20 or 25 to 27 to a subject, wherein the knee replacement, medical device, or kit includes at least one temperature sensor and / or metabolic sensor, and

[0250] b) Detect changes in the temperature sensor and / or metabolic sensor, and thereby determine the presence of infection.

[0251] 63) The method as described in embodiment 62, wherein the detection step is a series of detections over time.

[0252] 64) The method as described in embodiment 62 or 63, wherein the change is a change of more than 1% over an hourly period.

[0253] 65) The method as described in embodiments 62 to 64, wherein the change is a continuous increase in temperature and / or metabolic activity over a 4-hour period.

[0254] Further embodiments can be provided by combining the various embodiments described above. All U.S. patents, U.S. patent application publications, U.S. patent applications, foreign patents, foreign patent applications, and non-patent publications referenced in this specification are incorporated herein by reference in their entirety. If it is necessary to employ the concepts of various patents, applications, and publications to provide other embodiments, aspects of the embodiments may be modified.

[0255] Generally, the terminology used in the following claims should not be construed as limiting the embodiments to the specific embodiments disclosed in the specification and embodiments, but should be interpreted as including all possible embodiments and the full scope of equivalent technical solutions of these embodiments. Therefore, the embodiments are not limited to this disclosure.

Claims

1. Knee replacement prostheses, including: Tibial component, or tibial component and patellar prosthesis, or tibial component and femoral component, or tibial component, patellar prosthesis and femoral component; Multiple sensors are connected to the tibial component, or to at least one of the tibial component, the patellar prosthesis, and the femoral component, wherein the multiple sensors consist of one or more rotation sensors and one or more acceleration sensors, and the rotation and acceleration sensors are located within the tibial component and configured to continuously measure acceleration and rotation at a rate of at least several times per second daily for postoperative monitoring of the subject's knee range of motion, wherein each measurement is associated with a time stamp and a date stamp to provide sensor data, and the sensor data includes the measurement of acceleration and rotation and the associated time stamp and date stamp for each measurement; A memory for storing sensor data from the plurality of sensors and event recording data of the object generated by an external signaling or triggering device in response to input from the object, wherein the event recording data includes records of events experienced by the object, and the events include pain, injury and / or instability, and wherein the memory is located inside the tibial component; as well as An antenna is provided for receiving the sensor data and the event recording data, and for transmitting the sensor data and the event recording data to a reading device using radio frequency (RF), the reading device being positioned outside but adjacent to the knee replacement prosthesis.

2. The knee replacement prosthesis of claim 1, wherein the acceleration sensor detects acceleration, tilt, vibration, and / or shock.

3. The knee replacement prosthesis as described in claim 1, further comprising: An electronic processor is located on and / or inside at least one of the tibial component, the patellar prosthesis, and / or the femoral component, which are electrically connected to the sensor.

4. The knee replacement prosthesis as described in claim 3, wherein the electrical connection is a wireless connection.

5. The knee replacement prosthesis of claim 4, wherein the memory is connected to the electronic processor and disposed within the tibial component.

6. The knee replacement prosthesis of claim 1, wherein the plurality of sensors are arranged inside the knee replacement prosthesis at a density greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per square centimeter.

7. The knee replacement prosthesis of claim 1, wherein the plurality of sensors are arranged inside the knee replacement prosthesis at a density greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per cubic centimeter.

8. The knee replacement prosthesis of claim 1, wherein one or more of the sensors are randomly disposed inside the knee replacement prosthesis, and / or disposed at a specific location inside the knee replacement prosthesis.

9. Medical devices, including: Tibial component of knee replacement prostheses; Multiple sensors connected to the tibial component, wherein the multiple sensors consist of one or more rotation sensors and one or more acceleration sensors, and the rotation sensors and acceleration sensors are located within the tibial component and configured to continuously measure acceleration and rotation at a rate of at least several times per second daily for postoperative monitoring of the subject's knee range of motion, wherein each measurement is associated with a time stamp and a date stamp to provide sensor data, and the sensor data includes the measurement of acceleration and rotation and the associated time stamp and date stamp for each measurement; A memory for storing sensor data from the plurality of sensors and event recording data of the object generated by an external signaling or triggering device in response to input from the object, wherein the event recording data includes records of events experienced by the object, and the events include pain, injury and / or instability, and wherein the memory is located inside the tibial component; as well as An antenna is provided for receiving the sensor data and the event recording data, and for transmitting the sensor data and the event recording data to a reading device using radio frequency (RF), the reading device being positioned outside but adjacent to the knee replacement prosthesis.

10. The medical device of claim 9, wherein, The accelerometer detects acceleration, tilt, vibration, and / or shock.

11. The medical device of claim 9, further comprising: An electronic processor is located on and / or inside the tibial component that is electrically connected to the sensor.

12. The medical device of claim 11, wherein the electrical connection is a wireless connection.

13. The medical device of claim 12, wherein the memory is connected to the electronic processor and disposed within the tibial component.

14. The medical device of claim 9, wherein the plurality of sensors are arranged inside the knee replacement prosthesis at a density greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per square centimeter.

15. The medical device of claim 9, wherein the plurality of sensors are arranged inside the knee replacement prosthesis at a density greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per cubic centimeter.

16. The medical device of claim 9, wherein one or more of the sensors are randomly disposed inside the medical device and / or disposed at a specific location inside the medical device.

17. A method implemented by a computing device, comprising: Acceleration data is obtained from acceleration sensors located in situ within the knee replacement prosthesis as described in any one of claims 1 to 8 or the medical device as described in any one of claims 9 to 16, at multiple locations; The acceleration data is stored in a memory located in the knee replacement prosthesis or medical device; and The acceleration data is transferred from the memory located in the knee replacement prosthesis or medical device to a memory located outside the knee replacement prosthesis or medical device.

18. A method implemented by a computing device for detecting and / or recording events in a subject using a knee replacement prosthesis as claimed in any one of claims 1 to 8 or a medical device as claimed in any one of claims 9 to 16, comprising: The activity of one or more sensors located inside the knee replacement prosthesis or medical device is queried and recorded at a desired time point.

19. The method of claim 18, wherein the inquiry step is performed by a subject having an implanted knee replacement prosthesis or medical device.

20. The method of claim 19, wherein the recording step is performed on a wearable device.

21. The method of any one of claims 18 to 20, wherein the recording step is provided to a healthcare provider.

22. A method, implemented by a computing device, for monitoring a knee replacement prosthesis as described in any one of claims 1 to 8 or a medical device as described in any one of claims 9 to 16 located inside an object, comprising: Transmitting wireless electrical signals from a location located outside the body of the object to a location located inside the body; The wireless electrical signal is received at a sensor located inside the knee replacement prosthesis or medical device located inside the body; The sensor is powered by the received wireless electrical signal; Data is sensed at the sensor; as well as The sensed data is output from the sensor to a receiving unit located outside the body.

23. The method of claim 22, wherein the receiving unit is a watch, wristband, cellular phone, or glasses.

24. The method of claim 22, wherein the receiving unit is located inside the object's residence or office.

25. The method of claim 22, wherein the sensed data is provided to a healthcare provider.

26. The method of claim 22, wherein the sensed data is published to one or more websites.

27. The method of claim 22, wherein the data is analyzed.

28. The method of claim 27, wherein the data is plotted to enable visualization of changes over time.

29. The method of claim 27 or 28, wherein the data is plotted to provide a three-dimensional image.

30. A non-transitory computer-readable storage medium storing contents that configures a computing system to perform a method, said method comprising: The identified object has at least one wireless knee replacement prosthesis or medical device, each of the wireless knee replacement prosthesis or medical device having one or more wireless sensors, wherein the wireless knee replacement prosthesis is the knee replacement prosthesis of any one of claims 1 to 8, or the wireless medical device is the medical device of any one of claims 9 to 16. Manage the wireless interrogation unit to acquire sensor data from at least one of the respective one or more wireless sensors; as well as Receive the collected sensor data.

31. The non-transitory computer-readable storage medium of claim 30, wherein the stored content configures a computing system to perform a method, the method further comprising: Identify multiple objects, each of which has at least one wireless knee replacement prosthesis or medical device, and each of the wireless knee replacement prosthesis or medical device has one or more wireless sensors; Manage wireless interrogation units associated with each identified object to acquire sensor data from at least one of the corresponding one or more wireless sensors; Receive the collected sensor data; as well as The total amount of sensor data collected.

32. The non-transitory computer-readable storage medium of claim 30, wherein the stored content configures a computing system to perform a method, the method further comprising: Remove sensitive object data from the collected sensor data; as well as The total sensor data is analyzed based on the sensor type.

33. The non-transitory computer-readable storage medium of claim 30, wherein the stored content configures a computing system to execute a method, wherein, The steps for managing the wireless interrogation unit include managing the control unit associated with the wireless interrogation unit.

34. The non-transitory computer-readable storage medium of claim 30, wherein the acquired sensor data is received on a watch, wristband, cellular phone, or glasses.

35. The non-transitory computer-readable storage medium of claim 30, wherein the collected sensor data is received inside the object's residence or office.

36. The non-transitory computer-readable storage medium of claim 30, wherein the acquired sensor data is provided to a healthcare provider.

37. The non-transitory computer-readable storage medium of claim 30, wherein the sensor data is published to one or more websites.

38. The non-transitory computer-readable storage medium of claim 30, wherein the data is analyzed.

39. The non-transitory computer-readable storage medium of claim 30, wherein the data is plotted to enable visualization of changes over time.

40. The non-transitory computer-readable storage medium of claim 38 or 39, wherein the data is plotted to provide a three-dimensional image.

Images