Devices, systems and methods for monitoring knee replacements

Abstract

Knee replacement prosthesis are provided, comprising a plurality of sensors and at least one of a femoral component, a patellar prosthesis and a tibial component.

What is claimed is: 
     
         1 . A knee replacement prosthesis comprising:
 at least one of a tibial component, a patellar prosthesis, and a femoral component; and   a plurality of sensors coupled to at least one of the tibial component, patellar prosthesis, and femoral component.   
     
     
         2 . The knee replacement prosthesis of  claim 1  wherein the plurality of sensors includes a sensor on the tibial component. 
     
     
         3 . The knee replacement prosthesis of  claim 1  wherein the plurality of sensors includes a sensor on the patellar prosthesis. 
     
     
         4 . The knee replacement prosthesis of  claim 1  wherein the plurality of sensors includes a sensor on the femoral component. 
     
     
         5 . The knee replacement prosthesis according to any one of  claims 1  to  4  wherein said sensor is selected from the group consisting of accelerometers, pressure sensors, contact sensors, position sensors, chemical microsensors, tissue metabolic sensors, mechanical stress sensors and temperature sensors. 
     
     
         6 . The knee replacement prosthesis according to  claim 5  wherein said accelerometer detects acceleration, tilt, vibration, shock and or rotation. 
     
     
         7 . The knee replacement prosthesis of  claim 1  wherein the plurality of sensors includes contact sensors positioned on the femoral component. 
     
     
         8 . The knee replacement prosthesis of  claim 1  wherein the plurality of sensors includes a plurality of contact sensors positioned on the patellar component. 
     
     
         9 . The knee replacement prosthesis of  claim 1  wherein the plurality of sensors includes a plurality of contact sensors positioned on the tibial component. 
     
     
         10 . A medical device, comprising a femoral component of a knee replacement prosthesis and a plurality of sensors coupled to said femoral component. 
     
     
         11 . A medical device, comprising a patellar prosthesis of a knee replacement prosthesis and a plurality of sensors coupled to said patellar prosthesis. 
     
     
         12 . A medical device, comprising a tibial component of a knee replacement and a plurality of sensors coupled to said tibial component. 
     
     
         13 . The medical device according to any one of  claims 10  to  12 , wherein said sensors appear within and/or on the surface of said medical device. 
     
     
         14 . The medical device according to any one of  claims 10  to  13  wherein said sensor is selected from the group consisting of accelerometers, pressure sensors, contact sensors, position sensors, chemical microsensors, tissue metabolic sensors, mechanical stress sensors and temperature sensors. 
     
     
         15 . The medical device according to  claim 14  wherein said accelerometer detects acceleration, tilt, vibration, shock and or rotation. 
     
     
         16 . The knee replacement prosthesis according to any one of  claims 1  to  9  or medical device according to any one of  claims 10  to  15  further comprising:
 an electronic processor positioned upon and/or inside at least one of the tibial component, patellar prosthesis and/or the femoral component that is electrically coupled to sensors. 
 
     
     
         17 . The knee replacement prosthesis or medical device of  claim 16  wherein the electric coupling is a wireless coupling. 
     
     
         18 . The knee replacement prosthesis or medical device of  claim 17  further including:
 a memory coupled to the electronic processor and positioned upon and/or inside the at least one of tibial component, patellar prosthesis and femoral component. 
 
     
     
         19 . The knee replacement prosthesis or medical device according to any one of  claims 1  to  18  wherein said sensor is a plurality of sensors which are positioned on or within said knee replacement at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per square centimeter. 
     
     
         20 . The knee replacement or medical device according to any one of  claims 1  to  19  wherein said sensor is a plurality of sensors which are positioned on or within said knee replacement at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per cubic centimeter. 
     
     
         21 . A method comprising:
 obtaining contact data from contact sensors positioned at a plurality of locations between on and/or within a knee replacement prosthesis or medical devices according to any one of  claims 1  to  20  of a patient;   storing the data in a memory device located on or within the knee replacement prosthesis or medical device; and   transferring the data from the memory to a location outside the knee replacement prosthesis or medical device.   
     
     
         22 . The method according to  claim 22  further including:
 obtaining strain data from strain sensors positioned at a plurality of locations on the knee replacement prosthesis or medical device of a patient; 
 storing the strain data in a memory located in said knee replacement prosthesis or medical device; and 
 transferring the strain data from the memory to a memory in located outside the knee replacement prosthesis or medical device. 
 
     
     
         23 . The method according to  claim 22  further including:
 obtaining contact data from contact sensors positioned in a knee replacement prosthesis or medical device according to any one of  claims 1  to  19  of a patient; 
 storing the contact data in a memory located in the knee replacement prosthesis or medical device; and 
 transferring the data from the memory to a memory in a location outside of the knee replacement prosthesis or medical device. 
 
     
     
         24 . A method comprising:
 obtaining acceleration data from accelerometers positioned at a plurality of locations on a knee replacement prosthesis or medical device according to any one of  claims 1  to  19  located in-situ in the knee of a patient;   storing the acceleration data in a memory located in the knee replacement prosthesis or medical device; and   transferring the acceleration data from the said memory in the knee replacement prosthesis or medical device to a memory in a location outside the knee replacement prosthesis or medical device.   
     
     
         25 . A kit comprising the knee replacement prosthesis or medical device according to any one of  claims 1  to  19 , further comprising bone cement and/or bone screws comprising one or more sensors. 
     
     
         26 . The kit according to  claim 25  wherein said one or more sensors are selected from the group consisting of accelerometers, pressure sensors, contact sensors, position sensors, chemical microsensors, tissue metabolic sensors, mechanical stress sensors and temperature sensors. 
     
     
         27 . The kit according to  claim 25  or  26  wherein said sensors appear on said prosthesis or medical device at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per square centimeter. 
     
     
         28 . The knee replacement, medical device, or kit according to any one of  claim 1 - 20  or  25 - 27  wherein the one or more of the sensors are placed randomly within the knee replacement, medical device or kit, and/or at specific locations within the knee replacement, medical device or kit. 
     
     
         29 . A method for detecting and/or recording an event in a subject with a knee replacement or medical device as provided in any one of  claims 1  to  28 , comprising the step of interrogating at a desired point in time the activity of one or more sensors within the knee replacement or medical device, and recording said activity. 
     
     
         30 . The method according to  claim 29  wherein the step of interrogating is performed by a subject which has an implanted knee replacement or medical device. 
     
     
         31 . The method according to  claim 30  wherein said recording is performed on a wearable device. 
     
     
         32 . The method according to any one of  claims 29  to  31 , wherein said recording is provided to a health care provider. 
     
     
         33 . A method for imaging a knee replacement, medical device or kit according to any one of  claims 1  to  20  or  25  to  27 , comprising the steps of
 (a) detecting the location of one or more sensors in a knee replacement, medical device, or kit according to any one of  claims 1  to  20  or  25  to  27 ; and 
 (b) visually displaying the location of said one or more sensors, such that an image of the knee replacement or medical device is created. 
 
     
     
         34 . The method according to  claim 33  wherein the step of detecting occurs over time. 
     
     
         35 . The method according to  claim 34 , wherein said visual display shows changes in the positions of said sensors over time. 
     
     
         36 . The method according to any one of  claims 33  to  35  wherein said visual display is a three-dimensional image of said knee replacement or medical device. 
     
     
         37 . A method for inserting a knee replacement, medical device or kit according to any one of  claims 1  to  20  or  25  to  27 , comprising the steps of
 (a) inserting a medical device according to any one of  claims 1  to  20  or  25  to  27  into a subject; and 
 (b) imaging the placement of said medical device according to the method of any one of  claims 33  to  36 . 
 
     
     
         38 . A method for examining a knee replacement, medical device or kit according to any one of  claims 1  to  20  or  25  to  27  which has been previously inserted into a patient, comprising the step of imaging the knee replacement or medical device according to the method of any one of  claims 33  to  36 . 
     
     
         39 . A method of monitoring a knee replacement, medical device, or kit within a subject, comprising:
 transmitting a wireless electrical signal from a location outside the body to a location inside the subject's body;   receiving the signal at a sensor positioned on a knee replacement, medical device, or kit according to any one of  claims 1  to  20  or  25  to  27  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 of the body.   
     
     
         40 . The method according to  claim 39  wherein said receiving unit is a watch, wrist band, cell phone or glasses. 
     
     
         41 . The method according to  claim 39  or  40  wherein said receiving unit is located within a subject's residence or office. 
     
     
         42 . The method according to claims any one of  claims 39  to  41  wherein said sensed data is provided to a health care provider. 
     
     
         43 . The method according to any one of  claims 39  to  42  wherein said sensed data is posted to one or more websites. 
     
     
         44 . A non-transitory computer-readable storage medium whose stored contents configure a computing system to perform a method, the method comprising:
 identifying a subject, the identified subject having at least one wireless knee replacement, medical device, or kit according to any one of  claims 1  to  20  or  25  to  27 , each wireless knee replacement, medical device, or kit having one or more wireless sensors;   directing a wireless interrogation unit to collect sensor data from at least one of the respective one or more wireless sensors; and   receiving the collected sensor data.   
     
     
         45 . The non-transitory computer-readable storage medium of  claim 44  whose stored contents configure a computing system to perform a method, the method further comprising:
 identifying a plurality of subjects, each identified subject having at least one wireless knee replacement, medical device, or kit, each wireless knee replacement, medical device, or kit having one or more wireless sensors; 
 directing a wireless interrogation unit associated with each identified subject to collect sensor data from at least one of the respective one or more wireless sensors; 
 receiving the collected sensor data; and 
 aggregating the collected sensor data. 
 
     
     
         46 . The non-transitory computer-readable storage medium of  claim 44  whose stored contents configure a computing system to perform a method, the method further comprising:
 removing sensitive subject data from the collected sensor data; and 
 parsing the aggregated data according to a type of sensor. 
 
     
     
         47 . The non-transitory computer-readable storage medium of  claim 44  whose stored contents configure a computing system to perform a method, wherein directing the wireless interrogation unit includes directing a control unit associated with the wireless interrogation unit. 
     
     
         48 . The non-transitory computer readable storage medium according to any one of  claims 44  to  47 , wherein said knee replacement, medical device, or kit is an assembly according to any one of  claims 1  to  20  or  25  to  27 . 
     
     
         49 . The storage medium according to any one of  claims 44  to  48  wherein said collected sensor data is received on a watch, wrist band, cell phone or glasses. 
     
     
         50 . The storage medium according to any one of  claims 44  to  49  wherein said collected sensor data is received within a subject's residence or office. 
     
     
         51 . The storage medium according to any one of  claims 44  to  50  wherein said collected sensed data is provided to a health care provider. 
     
     
         52 . The storage medium according to any one of  claims 44  to  51  wherein said sensed data is posted to one or more websites. 
     
     
         53 . The method according to any one of  claims 39  to  43 , or storage medium according to any one of  claims 44  to  52 , wherein said data is analyzed. 
     
     
         54 . The method or storage medium according to  claim 53  wherein said data is plotted to enable visualization of change over time. 
     
     
         55 . The method or storage medium according to  claim 53  or  54  wherein said data is plotted to provide a three-dimensional image. 
     
     
         56 . A method for determining degradation of a knee replacement, medical device or kit, comprising the steps of a) providing to a subject a knee replacement, medical device or kit according to any one of  claims 1  to  20  or  25  to  27 , and b) detecting a change in a sensor, and thus determining degradation of the knee replacement, medical device or kit. 
     
     
         57 . The method according to  claim 56  wherein said sensor is capable of detecting one or more physiological and/or locational parameters. 
     
     
         58 . The method according to  claim 56  or  57  wherein said sensor detects contact, fluid flow, pressure and/or temperature. 
     
     
         59 . The method according to any one of  claims 56  to  58  wherein said sensor detects a location within the subject. 
     
     
         60 . The method according to any one of  claims 56  to  59  wherein said sensor moves within the body upon degradation of the knee replacement. 
     
     
         61 . The method according to any one of  claims 56  to  60  wherein the step of detecting is a series of detections over time. 
     
     
         62 . A method for determining an infection associated with a knee replacement, medical device or kit comprising the steps of a) providing to a subject a knee replacement, medical device or kit according to any one of  claims 1  to  20  or  25  to  27 , wherein said knee replacement, medical device or kit comprises at least one temperature sensor and/or metabolic sensor, and b) detecting a change in said temperature sensor and/or metabolic sensor, and thus determining the presence of an infection. 
     
     
         63 . The method according to  claim 62  wherein the step of detecting is a series of detections over time. 
     
     
         64 . The method according to  claim 62  or  63  wherein said change is greater than a 1% change over the period of one hour. 
     
     
         65 . The method according to  claims 62  to  64  wherein said change is a continually increasing temperature and/or metabolic activity over the course of 4 hours.