System and method suitable for treatment of a patient with a neurological deficit by sequentially stimulating neural pathways using a system of discrete implantable medical devices

• US 20050137648A1
• Filed: 12/03/2004
• Published: 06/23/2005
• Est. Priority Date: 02/26/1997
• Status: Active Grant

• Current Assignee: Alfred E. Mann Foundation For Scientific Research
• Original Assignee: Alfred E. Mann Foundation For Scientific Research
• Inventors: Turk, Ruth, Schulman, Joseph H., Mandell, Lee J., Hansen, Morten, Zilberman, Yitzhak, Gord, John C., Kuschner, Doug, Davis, Ross, Burridge, Jane, Dell, Robert Dan, Notley, Scott V., Ripley, Anne Marie, Cosendai, Gregoire
• Granted Patent: US 7,460,911 B2
• Time in Patent Office: Days
• US Class Current: 607/48
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61B 5/07 Endoradiosondes
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4519 Muscles A61B5/389, A61B5/224 take precedence
• CPC Class Codes: A61B 5/4528 Joints A61B5/4533, A61B5/4538 take precedence
• CPC Class Codes: A61F 2/72 Bioelectric control, e.g. myoelectric
• CPC Class Codes: A61F 2002/5058 having means for restoring the perception of senses
• CPC Class Codes: A61F 2002/704 computer-controlled, e.g. robotic control
• CPC Class Codes: A61F 2002/705 Electromagnetic data transfer
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
• CPC Class Codes: A61N 1/37288 Communication to several implantable medical devices within one patient
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

A system and method that facilitates stimulating neural pathways, e.g., muscles and/or associated nerves, of a patient'"'"'s body for the purpose of therapeutic medical treatment by rehabilitating weakened muscles and using neuroplasticity to retrain sequential muscle movements and/or to provide the ability to directly deliver functional motor movements. Use of the present invention is of particular value for treating a patient following a stroke. More particularly, such systems are characterized by a plurality of discrete devices, preferably battery powered but may alternatively include RF-powered devices as well or in combination, configured for implanting within a patient'"'"'s body via injection, each device being configured to affect a parameter, e.g., via nerve and/or muscle stimulation and/or to sense a body parameter, e.g., temperature, O₂ content, physical position, electrical potential, etc., that operate under control of a system controller that coordinates the sequential stimulation via wireless commands to the implanted devices.

Claims

1. A system for sequentially activating a plurality of distinct neural pathways in a patient'"'"'s body, said system comprising:

a first set of one or more discrete implantable devices suitable for placement proximate to a first neural pathway for stimulating the first neural pathway;

a second set of one or more discrete implantable devices suitable for placement proximate to a second neural pathway for stimulating the second neural pathway;

wherein each of said implantable devices is contained within a sealed elongate housing having an axial dimension of less than 60 mm and a lateral dimension of less than 6 mm and includes at least two electrodes integral with and on opposing ends of said housing, whereby said housings are suitable for injection into the patient'"'"'s body and said implantable devices are configured for affecting at least one neural pathway of the patient'"'"'s body via said electrodes in response to first communication/control circuitry mounted within each said housing and responsive to a unique predefined identification address for each of said implantable devices;

a system controller having second communication/control circuitry configured for wireless communication with said first communication/control circuitry within each of said implantable devices; and

wherein

following a first activation sequence of said first neural pathway transmitted from said system controller to said first set of implantable devices, said system controller additionally transmits a temporally displaced second activation sequence to said second set of implantable devices.

2. The system of claim 1 additionally comprising:

a position sensor in communication with said system controller for determining the relative position of at least two portions of the patient'"'"'s body; and

wherein

said temporal displacement between transmitting said first and second activation sequences to said first and second sets of implantable devices is determined at least in part according to information communicated from said position sensor.

3. The system of claim 2 wherein said position sensor is positioned external to the patient'"'"'s body.

4. The system of claim 2 wherein at least a portion of said first and second sets of implantable devices is configured to wirelessly determine the relative positions of at least portions of said first and second sets of implantable devices and thus operate as said position sensor which is positioned internal to the patient'"'"'s body.

5. The system of claim 2 wherein at least two of said implantable devices are configured to be positioned at different portions of a selected muscle or muscle group and are additionally configured to wirelessly determine the relative positions of said devices and thereby the amount of extension or retraction of the selected muscle and accordingly movement of an associated body portion and thus said implantable devices operate as said position sensor which is positioned internal to the patient'"'"'s body.

6. The system of claim 2 wherein said position sensor is configured for wireless communication with said system controller.

7. The system of claim 1 wherein at least a portion of said implantable devices is configured to receive power from an externally-provided AC magnetic field.

8. The system of claim 7 wherein said system controller is located external to the patient'"'"'s body and said externally-provided AC magnetic field is provided from said system controller.

9. The system of claim 1 wherein at least a portion of said implantable devices additionally comprise a rechargeable battery that is suitable for charging via an externally-provided AC magnetic field.

10. The system of claim 1 wherein said system controller is configured for implantation within the patient'"'"'s body.

11. The system of claim 1 wherein said system controller is configured for use external to the patient'"'"'s body.

12. The system of claim 1 additionally comprising:

a third set of one or more discrete implantable devices suitable for placement proximate to a third neural pathway for stimulating the third neural pathway;

a proximity sensor in communication with said system controller for sensing the proximity of a portion of the patient'"'"'s body to a predetermined goal position; and

wherein

in response to said detected goal position, said system controller transmits a third activation sequence to one or more implantable devices in said third set of implantable devices.

13. The system of claim 12 wherein said proximity sensor is selected from the group consisting of a magnetic sensor, a metal sensor, an infrared sensor, an ultrasonic emitter/sensor, a radar emitter/sensor, an accelerometer, a pressure sensor, and a machine vision based controller.

14. The system of claim 12 wherein said proximity sensor is positioned proximate to the patient'"'"'s hand.

15. The system of claim 12 additionally comprising a container for capture by the patient'"'"'s hand and said goal position detected by said proximity sensor corresponds to a predetermined spaced relationship between the patient'"'"'s hand and said container.

16. The system of claim 15 wherein said proximity sensor is located proximate to said container.

17. The system of claim 15 wherein said proximity sensor is integral to said container.

18. The system of claim 12 wherein said proximity sensor is located external to the patient'"'"'s body and is configured to wirelessly communicate to said system controller.

19. The system of claim 12 wherein said proximity sensor is located external to the patient'"'"'s body and is configured to communicate with one or more implantable devices to determine the relative distance between said externally located proximity sensor and one or more of said implantable devices.

52. The system of claim 1 wherein said system controller commences said first activation sequence in response to an activation signal.

53. The system of claim 52 wherein said activation signal originates from a switch.

54. The system of claim 52 wherein said activation signal originates in response to a sensed neurological signal.

55. The system of claim 54 wherein said neurological signal is sensed by one of said implantable devices.

20. A system for sequentially activating a plurality of distinct neural pathways in a patient'"'"'s body, said system comprising:

a first set of one or more discrete implantable devices suitable for placement proximate to a first neural pathway for stimulating the first neural pathway corresponding to bending of the patient'"'"'s elbow;

a second set of one or more discrete implantable devices suitable for placement proximate to a second neural pathway for stimulating the second neural pathway corresponding to bending of the patient'"'"'s wrist;

a third set of one or more discrete implantable devices suitable for placement proximate to a third neural pathway for stimulating the third neural pathway corresponding to bending of one or more of the patient'"'"'s fingers;

wherein each of said implantable devices is contained within a sealed elongate housing having an axial dimension of less than 60 mm and a lateral dimension of less than 6 mm and includes at least two electrodes integral with and on opposing ends of said housing, whereby said housings are suitable for injection into the patient'"'"'s body and said implantable devices are configured for affecting at least one neural pathway of the patient'"'"'s body via said electrodes in response to first communication/control circuitry mounted within each said housing and responsive to a unique predefined identification address for each of said implantable devices;

a system controller having second communication/control circuitry configured for wireless communication with said first communication/control circuitry within each of said implantable devices; and

wherein

following a first activation sequence of said first neural pathway transmitted from said system controller to said first set of implantable devices, said system controller additionally transmits a temporally displaced second activation sequence to said second set of implantable devices and a third activation sequence to said third set of implantable devices.

21. The system of claim 20 additionally comprising:

a position sensor in communication with said system controller for determining the relative position of at least two portions of the patient'"'"'s body; and

wherein

said temporal displacement between transmitting said first and second activation sequences to said first and second sets of implantable devices is determined at least in part according to information communicated from said position sensor.

22. The system of claim 21 wherein said position sensor is positioned external to the patient'"'"'s body.

23. The system of claim 21 wherein at least a portion of said first and second sets of implantable devices is configured to wirelessly determine the relative positions of at least portions of said first and second sets of implantable devices and thus operate as said position sensor which is positioned internal to the patient'"'"'s body.

24. The system of claim 21 wherein at least two of said implantable devices are configured to be positioned at different portions of a selected muscle or muscle group and are additionally configured to wirelessly determine the relative positions of said devices and thereby the amount of extension or retraction of the selected muscle and accordingly movement of an associated body portion and thus said implantable devices operate as said position sensor which is positioned internal to the patient'"'"'s body.

25. The system of claim 21 wherein said position sensor is configured for wireless communication with said system controller.

26. The system of claim 20 wherein at least a portion of said implantable devices is configured to receive power from an externally-provided AC magnetic field.

27. The system of claim 26 wherein said system controller is located external to the patient'"'"'s body and said externally-provided AC magnetic field is provided from said system controller.

28. The system of claim 20 wherein at least a portion of said implantable devices additionally comprise a rechargeable battery that is suitable for charging via an externally-provided AC magnetic field.

29. The system of claim 20 wherein said system controller is configured for implantation within the patient'"'"'s body.

30. The system of claim 20 wherein said system controller is configured for use external to the patient'"'"'s body.

31. The system claim 20 additionally comprising:

a proximity sensor in communication with said system controller for sensing the proximity of the patient'"'"'s hand to a predetermined goal position; and

wherein

in response to said detected goal position, said system controller transmits a third activation sequence to one or more implantable devices in said third set of implantable devices.

32. The system of claim 31 wherein said proximity sensor is selected from the group consisting of a magnetic sensor, a metal sensor, an infrared sensor, an ultrasonic emitter/sensor, a radar emitter/sensor, an accelerometer, a pressure sensor, and a machine vision based controller.

33. The system of claim 30 wherein said proximity sensor is positioned proximate to the patient'"'"'s hand.

34. The system of claim 30 additionally comprising a container for capture by the patient'"'"'s hand and said goal position detected by said proximity sensor corresponds to a predetermined spaced relationship between the patient'"'"'s hand and said container.

35. The system of claim 34 wherein said proximity sensor is located proximate to said container.

36. The system of claim 34 wherein said proximity sensor is integral to said container.

37. The system of claim 30 wherein said proximity sensor is located external to the patient'"'"'s body and is configured to wirelessly communicate to said system controller.

38. The system of claim 30 wherein said proximity sensor is located external to the patient'"'"'s body and is configured to communicate with one or more implantable devices to determine the relative distance between said externally located proximity sensor and one or more of said implantable devices.

39. The system claim 20 additionally comprising:

a proximity sensor in communication with said system controller for sensing that the patient'"'"'s hand has reached a predetermined goal position; and

wherein

in response to detecting that the patient'"'"'s hand has reached said detected goal position, said system controller transmits a third activation sequence to one or more implantable devices in said third set of implantable devices.

40. The system of claim 39 wherein said proximity sensor is selected from the group consisting of a magnetic sensor, a metal sensor, an infrared sensor, an ultrasonic emitter/sensor, an accelerometer, a pressure sensor, an electrical signal detector, and a machine vision based controller.

56. The system of claim 20 wherein said system controller commences said first activation sequence in response to an activation signal.

57. The system of claim 56 wherein said activation signal originates from a switch.

58. The system of claim 56 wherein said activation signal originates in response to a sensed neurological signal.

59. The system of claim 58 wherein said neurological signal is sensed by one of said implantable devices.

41. A method for sequentially activating a plurality of distinct neural pathways in a patient'"'"'s body for treatment of a patient having a neurological deficit using a system device and a plurality of associated discrete implantable slave devices that wirelessly communicate with said system device wherein said implantable slave devices comprise sets of one or more slave devices wherein each set is associated with a neurological pathway and is suitable for stimulating its associated neural pathway, said method comprising the steps of:

causing said master device to wirelessly activate one or more slave devices in a first set of slave devices to stimulate a first neural pathway; and

causing said master device to wirelessly activate one or more slave devices in a second set of slave devices to stimulate a second neural pathway, wherein said second set of slave devices are stimulated during a time period following the stimulation of the first neural pathway.

42. The method of claim 41 additionally comprising the step of sensing the relative position of at least two body portions and in response to achieving a desired relative position, causing said master device to activate one or more slave devices in said second set of slave devices.

43. The method of claim 41 additionally comprising the step of sensing the relative position of at least two body portions using said master device and in response to achieving a desired relative position, causing said master device to activate one or more slave devices in said second set of slave devices.

44. The method of claim 41 additionally comprising the step of causing said master device to activate one or more slave devices in a third set of slave devices to stimulate a third neural pathway, wherein said third set of slave devices are stimulated during a time period following the stimulation of the second neural pathway.

45. The method of claim 41 additionally comprising the step of sensing the proximity of a portion of the patient'"'"'s body to a goal position and upon reaching said goal position causing said master device to wirelessly activate one or more slave devices in said third set of slave devices to stimulate the third neural pathway.

46. The method of claim 42 additionally comprising the step of sensing the rate of change of the relative positions of at least two body portions and in response causing said master device to alter stimulation parameters of at least one of said slave devices.

47. The method of claim 46 additionally comprising the step of causing said master device to communicate data to an external device corresponding to changes in the stimulation parameters of at least one of said slave devices and thereby communicate data corresponding to the patient'"'"'s response to treatment.

48. The method of claim 42 additionally comprising the step of sensing the rate of change of the relative positions of at least two body portions and in response causing said master device to communicate data corresponding to the patient'"'"'s response to treatment.

60. The method of claim 41 wherein said step of causing said master device to wirelessly activate one or more slave devices in a first set of slave devices to stimulate a first neural pathway occurs in response to an activation signal.

61. The method of claim 41 wherein said step of causing said master device to wirelessly activate one or more slave devices in a first set of slave devices to stimulate a first neural pathway occurs in response to an activation signal originating from a switch.

62. The method of claims 41 wherein said step of causing said master device to wirelessly activate one or more slave devices in a first set of slave devices to stimulate a first neural pathway occurs in response to sensing a neurological signal.

63. The method of claims 41 wherein said step of causing said master device to wirelessly activate one or more slave devices in a first set of slave devices to stimulate a first neural pathway occurs in response to sensing a neurological signal with one of said discrete implantable slave devices.

49. A system for determining the movement of a body portion associated with a selected muscle or muscle group, said system comprising:

a first implantable device suitable for implantation in a first portion of the selected muscle or muscle group;

a second implantable device suitable for implantation in a second portion of the selected muscle or muscle group;

wherein each of said implantable devices is contained within a sealed elongate housing having an axial dimension of less than 60 mm and a lateral dimension of less than 6 mm, whereby said housings are suitable for injection into the patient'"'"'s body; and

wherein said implantable devices are configured to wirelessly communicate signals to determine their relative distance and accordingly the relative extension or retraction of the selected muscle or muscle group and accordingly movement of the associated body portion.

50. The system of claim 49 wherein said implantable devices additionally include at least two electrodes integral with and on opposing ends of said housing and are configured for affecting at least one neural pathway of the patient'"'"'s body via said electrodes in response to signals received by first communication/control circuitry mounted within each said housing and responsive to a unique predefined identification address for each of said implantable devices.

51. The system of claim 49 additionally comprising a system controller having second communication control circuitry configured for wireless communication with said first communication/control circuitry within each of said implantable devices to send command signals to each of said implantable devices;

and wherein

said system controller is configured to modify command signals to said implantable devices that cause stimulation of neural pathways within the patient'"'"'s body in response to relative distance signals measured by said implantable devices.