SYSTEM AND METHOD FOR NEURO-STIMULATION

• US 20080077192A1
• Filed: 10/29/2007
• Published: 03/27/2008
• Est. Priority Date: 05/03/2002
• Status: Abandoned Application

• Current Assignee: Trustees of Boston University
• Original Assignee: Afferent Corporation
• Inventors: Kellogg, Scott, D'Andrea, Susan, Harry, Jason, Niemi, James
• Application Number:
  US11/927,597
• Publication Number:
  US 20080077192A1
• Time in Patent Office: Days
• US Class Current: 607/48
• CPC Class Codes: A61F 5/0026 Anti-eating devices using electrical stimulation
• CPC Class Codes: A61H 2201/1207 with electric or magnetic drive
• CPC Class Codes: A61H 2201/165 Wearable interfaces
• CPC Class Codes: A61H 2201/5007 computer controlled
• CPC Class Codes: A61H 2201/5023 Interfaces to the user
• CPC Class Codes: A61H 2201/5043 Displays
• CPC Class Codes: A61H 2201/5058 Sensors or detectors
• CPC Class Codes: A61H 23/004 With mechanical drive, e.g. spring mechanism or vibrating unit being hit for starting vibration and then applied to the body of a patient
• CPC Class Codes: A61H 23/02 with electric or magnetic drive
• CPC Class Codes: A61H 23/0263 using rotating unbalanced masses
• CPC Class Codes: A61N 1/0452 Specially adapted for transcutaneous muscle stimulation [TMS]
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0464 Specially adapted for promoting tissue growth
• CPC Class Codes: A61N 1/0472 Structure-related aspects
• CPC Class Codes: A61N 1/0476 Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• CPC Class Codes: A61N 1/0484 Garment electrodes worn by the patient
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/321 Electromedical belts
• CPC Class Codes: A61N 1/36003 of motor muscles, e.g. for walking assistance
• CPC Class Codes: A61N 1/36007 : of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/3601 : of respiratory organs
• CPC Class Codes: A61N 1/36017 : with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 : for treatment of pain
• CPC Class Codes: A61N 1/36034 : specified by the stimulation parameters
• CPC Class Codes: A61N 1/36071 : Pain
• CPC Class Codes: A61N 1/36164 : Sub-threshold or non-excitatory signals non-excitatory signals to the heart A61N1/3628
• CPC Class Codes: A61N 1/3627 : for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/37247 : User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 2/006 : for magnetic stimulation of nerve tissue

Abstract

A neuro-stimulation system employs a includes a stimulator which may include electrode devices and/or vibration elements. A controller may be employed to drive the stimulating elements with an electrical signal. In response to the electrical signal, the stimulating elements deliver electrical and/or mechanical stimulation to the body part. The stimulation may be an aperiodic stimulation and/or may be a subthreshold stimulation. In one embodiment, the stimulator is disposable and the processor determines usage of the stimulator and ensures that the stimulator is limited to a certain amount of use. Neuro-stimulation systems may be applied to sensory cells of body parts during movement of the body parts to induce neuroplastic changes. Such movement may involve a variety of therapeutic applications, e.g. in stroke patient therapy.

Claims

1. A system for providing neuro-stimulation to a body part, the system comprising:

a controller including;

a user interface;

a power supply;

at least one electrical connector; and

a processor with software, the processor determining, according to values entered into the user interface, an electrical signal directed from the power supply to the at least one electrical connector; and

a stimulator adapted to be detachably coupled to the controller via the at least one electrical connector, the stimulator including;

a plurality of stimulating elements, including at least one electrode device and at least one vibration element; and

an attachment element to attach the stimulator to a body part,

wherein the controller is operable to drive at least one of the stimulating elements with an electrical signal, and in response to the electrical signal, at least one of the stimulating elements provides a stimulation for the body part, the stimulation being at least one of a subthreshold stimulation and an aperiodic stimulation.

2. The system according to claim 1, wherein the controller has an operational mode in which only the at least one electrode device provides the stimulation.

3. The system according to claim 1, wherein the controller has an operational mode in which only the at least one vibration element provides the stimulation.

4. The system according to claim 1, further comprising a battery charging console, the battery charging console receiving power from an external power supply and providing power from the external power supply to at least one rechargeable battery through a recharging contact when the controller is received by the battery charging console, wherein the power supply includes the at least one rechargeable battery.

5. The system according to claim 1, wherein the stimulator further comprises a data storage device storing usage data for the stimulator.

6. The system according to claim 5, wherein the usage data includes a total amount of time that the stimulator has been employed to provide stimulation for the body part.

7. The system according to claim 6, wherein, when the stimulator is detachably connected to the controller, the processor updates the total amount of time as the stimulator provides stimulation for the body part.

8. The system according to claim 7, wherein, when the stimulator is detachably connected to the controller, the processor does not deliver the electrical signal to the stimulator if the processor determines that the total amount of time exceeds a time limit value.

9. The system according to claim 5, wherein the usage data includes a usage indicator indicating whether the stimulator has been used.

10. The system according to claim 9, wherein, after the stimulator is detachably coupled to the controller and the processor determines from the usage indicator that the stimulator has not been previously used, the processor communicates data to the usage indicator indicating that the stimulator has been used.

11. The system according to claim 10, wherein, after the stimulator is detachably coupled to the controller and the processor determines from the usage indicator that the stimulator has been previously used, the processor does not deliver the electrical signal to the stimulator.

12. The system according to claim 5, wherein the stimulator further includes a flex circuit connecting the at least one electrode device, the at least one vibration element, and the data storage device, and the processor is connected to the flex circuit when the stimulator is detachably connected to the controller.

13. The system according to claim 12, wherein the at least one electrical connector comprises a n-pin connector, and the processor detects a coupling with the stimulator by detecting a short between two pins created by the flex circuit when the controller and the stimulator are detachably coupled via the n-pin connector.

14. The system according to claim 1, wherein the stimulation is directed to sensory cells of the body part to enhance detection of an external signal by a subject, the sensory cells corresponding to a sensory function of the body part.

15. A method of enhancing sensorimotor performance in a subject comprising the steps of:

inputting an aperiodic signal to at least one sensory cell area of the subject;

moving at least one body segment of the subject relative to another simultaneous with the step of inputting an aperiodic signal to at least one sensory cell area of the subject, wherein the at least one body segment utilizes sensory cells within the sensory cell area that is involved in the sensorimotor performance to be enhanced; and

inducing neuroplastic changes in the nervous system of the subject by inputting the aperiodic signal for a period of time long enough that the subject'"'"'s sensorimotor performance is enhanced.

16. The method according to claim 15, wherein the step of moving comprises moving according to a virtual reality system.

17. The method according to claim 15, wherein the step of moving comprises moving according to physical therapy.

18. The method according to claim 15, wherein the physical therapy is device-augmented therapy.

19. The method according to claim 18, wherein the device-augmented therapy uses a treadmill or an exercise bicycle.

20. The method according to claim 15, wherein the aperiodic signal is provided at a subthreshold level.

21. The method according to claim 15, further comprising the step of inputting a subthreshold signal to the at least one sensory cell area of the subject.

22. A method for providing neuro-stimulation to a body part with a neuro-stimulation device having a stimulator configured to provide at least one of an aperiodic stimulation and a subthreshold stimulation, the method comprising the step of applying, via the stimulator, at least one of an aperiodic stimulation and a subthreshold stimulation to at least one body part to mitigate muscle tension, contracture, or spasm resulting from neurodegenerative disease.

32. The method according to claim 22, 23, 24, 25, 27, 28, 29, 30, or 31 wherein the stimulation comprises electrical stimulation.

33. The method according to claim 22, 23, 24, 25, 27, 28, 29, 30, or 31 wherein the stimulation comprises mechanical stimulation.

34. The method according to claim 22, 23, 24, 25, 27, 28, 29, 30, or 31 wherein the stimulation comprises electrical and mechanical stimulation.

23. A method for providing neuro-stimulation to a body part with a neuro-stimulation device having a stimulator configured to provide at least one of an aperiodic stimulation and a subthreshold stimulation, the method comprising the step of applying, via the stimulator, at least one of an aperiodic stimulation and a subthreshold stimulation to an intercostal muscle in a chest area of an asthmatic patient to improve lung function.

24. A method for providing neuro-stimulation to a body part with a neuro-stimulation device having a stimulator configured to provide at least one of an aperiodic stimulation and a subthreshold stimulation, the method comprising the step of applying, via the stimulator, at least one of an aperiodic stimulation and a subthreshold stimulation to an area where pain is felt by a subject.

25. The method according to claim 24, wherein the pain is caused by musculoskeletal hyperextension or excursion resulting from proprioceptive deficit in the body part.

26. A method for providing neuro-stimulation to a body part with a neuro-stimulation device having a stimulator configured to provide at least one of an aperiodic stimulation and a subthreshold stimulation, the method comprising the step of applying, via the stimulator, at least one of an aperiodic stimulation and a subthreshold stimulation to a joint of a subject with a sensory deficit to enhance awareness of body movement and increase muscle strength.

27. A method for providing neuro-stimulation to a body part with a neuro-stimulation device having a stimulator configured to provide at least one of an aperiodic stimulation and a subthreshold stimulation, the method comprising the step of applying, via the stimulator, at least one of an aperiodic stimulation and a subthreshold stimulation to swallowing organs to improve swallowing function.

28. The method according to claim 27, wherein the swallowing function to be improved is the sensation of the presence of a solid or liquid bolus in the throat.

29. The method according to claim 27, wherein the swallowing function to be improved is timing of swallowing muscle contraction relative to movement of solid or liquid bolus in the throat.

30. The method according to claim 27, wherein the swallowing function to be improved is the timing of the closure of the trachea relative to the movement of solid or liquid bolus in the throat.

31. A method for improving cardiac function with a neuro-stimulation device having a stimulator configured to provide at least one of an aperiodic stimulation and a subthreshold stimulation, the method comprising applying, via the stimulator, at least one of an aperiodic stimulation and a subthreshold stimulation to a heart muscle, whereby resistance to overfilling is enhanced.

35. A method for enhancing sensory function in a subject, the method comprising:

providing a stimulation source to an external device, wherein the stimulation source provides a stimulation including at least one of a subthreshold stimulation and an aperiodic stimulation; and

receiving, with the external device, an interaction with a body part,

wherein the stimulation source applies the stimulation to sensory cells of the body part during the contact to enhance sensory function associated with the body part.

36. The method according to claim 35, wherein the interaction provides a tactile signal to the body part, and the stimulation enhances detection of the tactile signal with the sensory cells.

37. The method according to claim 36, wherein the body part is a fingertip, and the stimulation enhances detection of the tactile signal with the sensory cells.

38. The method according to claim 37, wherein the external device is a surface with Braille and the step of receiving an interaction comprises receiving the fingertip into a contact with the Braille surface.

39. The method according to claim 37, wherein the external device is a trigger of a firearm and the step of receiving an interaction comprises receiving the fingertip into contact with the trigger of a firearm.

40. The method according to claim 35, wherein the external device is a gun stock and the interaction provides a tactile signal through the gun stock to the body part, and the stimulation enhances detection of the gun stock position with the sensory cells.

41. The method according to claim 35, wherein the body part is a sexual organ, and the stimulation enhances detection of the tactile signal with the sensory cells.

42. The method according to claim 35, wherein the interaction provides an olfactory signal to a nose, and the stimulation enhances detection of the olfactory signal with the sensory cells.

43. The method according to claim 42, wherein the subject is a canine.

44. The method according to claim 43, wherein the step of receiving an interaction with the body part exposes the nose of the canine to contraband.

45. The method according to claim 35, wherein the interaction provides a visual signal to an eye, and the stimulation enhances detection of the visual signal with the sensory cells.

46. The method according to claim 35, wherein the interaction provides an aural signal to an ear, and the stimulation enhances detection of the aural signal with the sensory cells.

47. The method according to claim 46, wherein the external device is a hearing assistive device.

48. The method according to claim 35, wherein the interaction provides a flavor signal to a tongue, and the stimulation enhances detection of the flavor signal with the sensory cells.

49. A firearm for enhancing accuracy in shooting applications, the firearm comprising:

a controller including;

a power supply;

an electrical connector; and

a processor determining an electrical signal directed from the power supply to the electrical connector; and

at least one stimulator operably coupled to the controller via the electrical connector and positioned on at least one of a trigger and a gun stock, the at least one stimulator including at least one of an electrode device and a vibration element,

wherein, the processor is operable to drive at least one of the electrode device and the vibration element with the electrical signal, and

in response to the electrical signal, at least one of the electrode device and the vibration element provides a stimulation to sensory cells in contact with at least one of the trigger and the gun stock.

50. The system according to claim 50, wherein the controller has an operational mode in which the electrical signal has an aperiodic waveform.

51. The system according to claim 50, wherein the controller has an operational mode in which the stimulation to the body part is subthreshold.

52. A system for providing neuro-stimulation through contact with a body part, the system comprising:

a stimulator including;

a flexible, expandable attachment element having a surface area corresponding to a body part surface area and configured to be attached to the body part surface area; and

at least one electrode device attached to the attachment element to be positioned over the surface area of the body part,

wherein the stimulation is configured to provide at least one of an aperiodic stimulation and a subthreshold stimulation.

53. The system according to claim 53, wherein the attachment element is a mesh.

54. The system according to claim 53, wherein the attachment element is bioresorbable.

55. A system for providing neuro-stimulation through contact with a body part, the system comprising:

a stimulator including;

a flexible, expandable attachment element having a surface area corresponding to a body part surface area and configured to be attached to the body part surface area; and

at least one electrode device attached to the attachment element to be positioned over the surface area of the body part,

wherein the stimulation is configured to provide at least one of an aperiodic stimulation and a subthreshold stimulation.

the method comprising;

attaching the attachment element over the surface area of the body part;

applying, via the stimulator, at least one of an aperiodic stimulation and a subthreshold stimulation to the body part.

56. The method according to claim 56, wherein the step of attaching the attachment element comprises attaching the attachment element to the body part via sutures.

57. The method according to claim 56, wherein the body part is the bladder, colon, stomach, gall bladder, esophagus, intestines, urethra, or bile duct.

58. A mat comprising:

a top surface for contact a foot of a subject;

a bottom surface for contact with a floor;

a controller including;

a power supply;

an electrical connector; and

a circuit determining an electrical signal directed from the power supply to the electrical connector; and

a stimulator operably coupled to the controller via the electrical connector and operably coupled to the top surface,

wherein the processor is operable to drive the stimulator with the electrical signal, and in response to the electrical signal, the stimulator provides a stimulation to the top surface, the stimulation being at least one of an aperiodic stimulation and a subthreshold stimulation.

59. The mat according to claim 59, further comprising force sensors to detect a position of the foot, wherein the stimulator focuses delivery of the stimulation to the position.

60. A catheter comprising:

an elongate body,

a plurality of stimulators positioned along the elongate body,

wherein the one or more of the stimulators are configured to provide a stimulation, wherein the stimulation is at least one of an aperiodic stimulation or subthreshold stimulation.

61. A system for enhancing sensorimotor performance in a subject comprising:

a wearable device to which is secured at least one signal input device, wherein the at least one signal input device is repositionable on the wearable device; and

a signal generator for generating a bias signal, wherein the signal generator is communicatively coupled to the at least one signal input device.

62. The system of claim 62, wherein the signal generator includes a power source, a signal processor and a controller.

64. The system of claim 62, wherein the wearable device is adapted to forcibly press the signal input device to the subject'"'"'s skin surface.

65. The system of claim 62, wherein the wearable device is composed of stretchable fabric.

66. The system of claim 62, wherein the signal generator is repositionable and removably attached to the wearable device.

67. The system of claim 62, wherein the signal input device is electrically connected to the signal generator.

68. The system of claim 62, wherein the signal generator is communicatively coupled to the signal input device by an electrical conductor, at least a portion of the electrical conductor being secured within the wearable device and protected by the wearable device.

63. The system of claim 63, wherein the signal processor includes a calibration module for adjusting the bias signal produced by the signal processor.

69. A method of increasing growth hormone release in a subject comprising the step of:

increasing afferent signaling to the pituitary gland and growth hormone release by inputting at least one bias signal to at least one sensory cell area of a subject while the subject is performing a physical activity utilizing sensory cells within the sensory cell area, the bias signal causing the sensory cells to produce the growth hormone.

70. A method of increasing growth hormone release in a subject comprising the step of:

increasing afferent signaling to the pituitary gland and growth hormone release by inputting at least one bias signal to at least one sensory cell area of a subject while the subject is performing a physical activity which utilizes sensory cells within the sensory cell area,

wherein inputting the at least one bias signal improves the function of the sensory cells, the system comprising a wearable device to which at least one respositionable signal input device is secured, and a signal generator communicatively coupled to the at least one signal input device.

71. A system for improving neuroplasticity in a subject in accordance with the method of:

inputting at least one bias signal to at least one sensory cell area of a subject while the subject is performing a pre-defined physical activity which utilizes sensory cells within the sensory cell area and which are involved in the sensorimotor performance to be enhanced, wherein inputting the at least one bias signal improves the function of the sensory cells, and wherein the neuroplasticity is at least one of central neuroplasticity and peripheral neuroplasticity,

the system comprising;

a wearable device to which is secured at least one signal input device, wherein the at least one signal input device is repositionable on the wearable device; and

a signal generator for generating a bias signal, wherein the signal generator is communicatively coupled to the at least one signal input device.

72. The system of claim 72, wherein the signal generator includes a power source, a signal processor and a controller.

74. The system of claim 72, wherein the wearable device is adapted to forcibly press the signal input device to the subject'"'"'s skin surface.

75. The system of claim 72, wherein the wearable device is composed of stretchable fabric.

76. The system of claim 72, wherein the signal generator is repositionable and removably attached to the wearable device.

77. The system of claim 72, wherein the signal input device is electrically connected to the signal generator.

78. The system of claim 72, wherein the signal generator is communicatively coupled to the signal input device by an electrical conductor, at least a portion of the electrical conductor being secured within the wearable device and protected by the wearable device.

73. The system of claim 73, wherein the signal processor includes a calibration module for adjusting the bias signal produced by the signal processor.

79. A method of enhancing sensorimotor performance in a subject comprising the steps of:

inputting a stimulation to at least one sensory cell area of the subject, the stimulation being at least one of an aperiodic stimulation and a subthreshold stimulation;

moving, according to a virtual reality system, at least one body segment of the subject relative to another simultaneous with the step of inputting a stimulation to at least one sensory cell area of the subject, wherein the at least one body segment utilizes sensory cells within the sensory cell area that is involved in the sensorimotor performance to be enhanced; and

inducing neuroplastic changes in the nervous system of the subject by inputting the stimulation for a period of time long enough that the subject'"'"'s sensorimotor performance is enhanced.

80. A method of enhancing sensorimotor performance in a subject comprising the steps of:

moving, according to a virtual reality system, at least one body segment of the subject relative to another, wherein the at least one body segment utilizes sensory cells within the sensory cell area that is involved in the sensorimotor performance to be enhanced; and

inducing neuroplastic changes in the nervous system of the subject by moving the at least one body segment according to the virtual reality system for a period of time long enough that the subject'"'"'s sensorimotor performance is enhanced.