DEVICES, SYSTEMS AND METHODS FOR USING AND MONITORING SPINAL IMPLANTS

1 . An implantable medical device, comprising a pedicle screw, and a sensor.

2 . An implantable medical device, comprising a spinal wire, and a sensor.

3 . An implantable medical device, comprising a spinal rod, and a sensor.

4 . An implantable medical device, comprising a spinal plate, and a sensor.

5 . An implantable medical device, comprising a spinal cage, and a sensor.

6 . An implantable medical device, comprising an artificial disc, and a sensor.

7 . An implantable medical device kit, comprising a pedicle screw, a spinal rod and a sensor.

8 . An implantable medical device kit, comprising a pedicle screw, a spinal plate and a sensor.

9 . An implantable medical device, comprising a polymer and a sensor.

10 . The medical device according to claim 9 wherein said polymer is selected from the group consisting of a polymethylmethacrylate, a methylmethacrylate-styrene copolymer, fibrin, polyethylene glycol, carboxymethylcellulose, and polyvinylalcohol.

11 . An implantable medical device, comprising a kyphoplasty balloon, and a sensor.

12 . The medical device according to any one of claims 1 to 11 wherein said sensor is located within said implant.

13 . The medical device according to any one of claims 1 to 11 wherein said sensor is located on said implant.

14 . The medical device according to any one of claims 1 to 13 wherein said device is sterile.

15 . The medical device according to any one of claims 1 to 14 wherein said sensor is a contact sensor.

16 . The medical device according to any one of claims 1 to 14 wherein said sensor is a pressure sensor.

17 . The medical device according to any one of claims 1 to 14 wherein said sensor is an accelerometer sensor.

18 . The medical device according to claim 17 wherein said accelerometer detects acceleration, tilt, vibration, shock and or rotation.

19 . The medical device according to any one of claims 1 to 14 wherein said sensor is a temperature sensor.

20 . The medical device according to any one of claims 1 to 14 wherein said sensor is a mechanical stress sensor.

21 . The medical device according to any one of claims 1 to 14 wherein said sensor is selected from the group consisting of position sensors, chemical microsensors, and tissue metabolic sensors.

22 . The medical device according to any one of claims 1 to 22 further comprising:

an electronic processor positioned upon and/or inside the spinal device/implant or medical device that is electrically coupled to sensors.

23 . The medical device according to claim 22 wherein the electric coupling is a wireless coupling.

24 . The medical device according to claim 22 further including:

a memory coupled to the electronic processor and positioned upon and/or inside the spinal device/implant or medical device.

25 . The medical device according to any one of claims 1 to 24 wherein said sensor is a plurality of sensors which are positioned on or within said medical device at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per square centimeter.

26 . The medical device according to any one of claims 1 to 24 wherein said sensor is a plurality of sensors which are positioned on or within said medical device at a density of greater than 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 20 sensors per cubic centimeter.

27 . A method comprising:

obtaining data from sensors positioned at a plurality of locations between on and/or within the medical device according to any one of claims 1 to 26 of a patient;

storing the data in a memory device located on or within the medical device; and

transferring the data from the memory to a location outside the medical device.

28 . The method according to claim 27 further comprising the step of analyzing said data.

29 . A method for detecting and/or recording an event in a subject with the medical device according to any one of claims 1 to 26 , comprising the step of interrogating at a desired point in time the activity of one or more sensors within the 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 said medical device.

31 . The method according to claim 29 or 30 wherein said recording is performed on a wearable device.

32 . The method according to any one of claim 29 , 30 or 31 , wherein said recording, or a portion thereof, is provided to a health care provider.

33 . A method for imaging the medical device in the spine, comprising the steps of

(a) detecting the location of one or more sensors in the medical device according to any one of claims 1 to 26 ; and

(b) visually displaying the location of said one or more sensors, such that an image of the medical device, or a portion thereof, in the spine is created.

34 . The method according to claim 33 wherein the step of detecting occurs over time.

35 . The method according to claim 33 or 34 , wherein said visual display shows changes in the positions of said sensors over time, and/or changes in temperature of the sensors or surrounding tissue 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 medical device in the spine.

37 . A method for inserting the spinal device/implant according to any one of claims 1 to 26 , comprising the steps of

(a) inserting an implantable medical device according to any one of claims 1 to 26 into a subject; and

(b) imaging the placement of said medical device according to the method of an one of claims 33 to 36 .

38 . A method for examining the spinal device/implant according to any one of claims 1 to 26 which has been previously inserted into a patient, comprising the step of imaging the spinal device/implant according to the method of any one of claims 33 to 36 .

39 . A method of monitoring a spinal device/implant within a subject, comprising:

(a) transmitting a wireless electrical signal from a location outside the body to a location inside the subject's body;

(b) receiving the signal at a sensor positioned on a spinal device/implant according to any one of claims 1 to 26 located inside the body;

(c) powering the sensor using the received signal;

(d) sensing data at the sensor; and

(e) 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:

(a) identifying a subject, the identified subject having at least one wireless spinal device/implant according to any one of claims 1 to 26 , each wireless spinal device/implant having one or more wireless sensors;

(b) directing a wireless interrogation unit to collect sensor data from at least one of the respective one or more wireless sensors; and

(c) 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:

(a) identifying a plurality of subjects, each identified subject having at least one wireless spinal device/implant, each wireless spinal device/implant having one or more wireless sensors;

(b) 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;

(c) receiving the collected sensor data; and

(d) 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:

(a) removing sensitive subject data from the collected sensor data; and

(b) 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 spinal device/implant is according to any one of claims 1 to 26 .

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.

55 . A method for determining degradation of a spinal device/implant, comprising the steps of a) providing to a subject a spinal device/implant according to any one of claims 1 to 26 , and b) detecting a change in a sensor, and thus determining degradation of the spinal device/implant.

56 . The method according to claim 55 wherein said sensor is capable of detecting one or more physiological and/or locational parameters.

57 . The method according to claim 55 or 56 wherein said sensor detects a location within the subject.

58 . The method according to any one of claims 55 to 58 wherein said sensor moves from its original location, thereby indicating degradation of the spinal device/implant.

59 . The method according to any one of claims 55 to 59 wherein the step of detecting is a series of detections over time.

60 . A method for determining an infection associated with a spinal device/implant, comprising the steps of a) providing to a subject a spinal device/implant according to any one of claims 1 to 26 , wherein said spinal device/implant 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.

61 . The method according to claim 60 wherein the step of detecting is a series of detections over time.

62 . The method according to claim 60 or 61 wherein said change is greater than a 1% change over the period of one hour.

63 . The method according to any one of claims 60 to 62 wherein said change is a continually increasing temperature and/or metabolic activity over the course of 4 hours.