REMOTELY CONTROLLED AND/OR LATERALLY SUPPORTED DEVICES FOR DIRECT SPINAL CORD STIMULATION

• US 20140128955A1
• Filed: 11/11/2011
• Published: 05/08/2014
• Est. Priority Date: 11/11/2010
• Status: Active Grant

• Current Assignee: University of Iowa Research Foundation
• Original Assignee: University of Iowa Research Foundation, University of Virginia Patent Foundation (University of Virginia)
• Inventors: Utz, Marcel, Gillies, George T., Nelson, Randall S., Howard, Matthew, Brennan, Timothy, Dalm, Brian, Scott, Steven, Shurig, Robert
• Granted Patent: US 9,364,660 B2
• Time in Patent Office: Days
• US Class Current: 607/117
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/37514 Brain implants
• CPC Class Codes: A61N 1/37518 Anchoring of the implants, e.g. fixation
• CPC Class Codes: A61N 1/3787 from an external energy source
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing

Abstract

A method for treating intractable pain via electrical stimulation of the spinal cord. Remote, non-contact stimulation of a selected region of spinal cord is achieved by placement of a transceiver patch directly on the surface of that region of spinal cord, with said patch optionally being inductively coupled to a transmitter patch of similar size on either the outer or inner wall of the dura surrounding that region of the spinal cord. By inductively exchanging electrical power and signals between said transmitter and transceiver patches, and by carrying out the necessary electronic and stimulus signal distribution functions on the transceiver patch, the targeted dorsal column axons can be stimulated without the unintended stray stimulation of nearby dorsal rootlets. Novel configurations of a pliable surface-sheath and clamp or dentate ligament attachment features which realize undamaging attachment of the patch to the spinal cord are described.

Claims

1-40. -40. (canceled)

41. A method for treating pain in a patient, the method comprising:

conformably positioning an electrode array over a surface of the patient'"'"'s spinal cord so that a plurality of individual electrodes in the array directly contact the spinal cord; and

delivering electrical stimulation to a targeted sub-region of the spinal cord to relieve pain without stimulating dorsal nerve rootlets.

42. The method of claim 41, wherein conformably positioning the electrode array comprises circumscribing a structure of the array around the spinal cord.

43. The method of claim 41, wherein the array structure has an elastic C-shaped structure which closes over the spinal cord while accommodating spinal cord pulsation.

44. The method of claim 41, wherein the electrode array, when circumscribing the spinal cord, does not substantially obstruct flow of cerebrospinal fluid (CSF), thereby reducing the risk of syrinx formation.

45. The method of claim 41, wherein conformably positioning the electrode array comprises conforming an elastic substrate over a dorsal surface of the spinal cord, wherein the elastic substrate and array form an array structure so that the elastic substrate supports the electrodes in engagement with the spinal cord while accommodating spinal cord pulsation.

46. The method of claim 41, further comprising supporting the electrode array with the spinal cord so that the array moves with the spinal cord when the spinal cord moves axially within the patient'"'"'s dura.

47. The method of claim 41, wherein delivering electrical stimulation comprises energizing preselected electrode patterns to target the sub-region.

48. The method of claim 41, wherein delivering electrical stimulation comprises wirelessly transmitting energy to the electrode array from a signal generator disposed over an external surface of the patient'"'"'s dura disposed over the electrode array.

49. The method of claim 41, wherein delivering electrical stimulation comprises transmitting energy to the electrode array from a signal generator disposed outside of the patient'"'"'s dura by way of a conductor extending through the patient'"'"'s dura.

50. The method of claim 49, wherein the dura has been closed around a fitting on the conductor to form a substantially water-tight closure.

51. The method of claim 41, which is a method for treating back pain, a musculo-skeletal disorder, a neoplasm, arthritic degeneration, a neurodegenerative disorder, or trauma.

52. A system configured for treating pain in a patient, the system comprising:

an array structure comprising a compliant backing with a plurality of electrodes supported thereupon so as to form an electrode array along an interior surface of the array structure,

wherein the array structure is configured to conform over a surface of the patient'"'"'s spinal cord so that the electrodes of the array directly contact the spinal cord; and

circuitry coupled with the electrodes, thereby configured to deliver electrical stimulation through the electrodes to a targeted sub-region of the spinal cord so as to relieve the pain without stimulating dorsal nerve rootlets.

53. The system of claim 52, wherein the array structure is configured to conform to the spinal cord so as to circumscribe a portion of the spinal cord.

54. The system of claim 52, wherein the array structure comprises an elastic C-shaped structure that engages the spinal cord so as to accommodate spinal cord pulsation.

55. The system of claim 52, wherein the array structure includes an elastic material coupling each electrode to the backing adjacent the electrode so that the electrodes move independently with respect to one another and with respect to the backing so as to inhibit motion of the electrode relative to the spinal cord during spinal cord pulsation.

56. The system of claim 52, wherein the array structure is configured so that when it is circumscribing the portion the spinal cord, cerebral spinal fluid (CSF) may flow between the surface and surrounding dura, thereby reducing the risk of syrinx formation.

57. The system of claim 52, wherein left and right dentate ligaments extend left and right between the spinal cord and surrounding dura of the patient, respectively;

the system further comprising left and right support features extendable laterally from the array structure and configured for attachment to the left and right dentate ligaments, respectively, so as to support the array structure in contact with the spinal cord such that the array structure moves with the spinal cord when the spinal cord moves within the patient'"'"'s dura.

58. The system of claim 52, wherein the circuitry is configured for delivering electrical stimulation in programmable preselected electrode patterns to target the sub-region.

59. The system of claim 52, further comprising a signal receiver disposed along the backing and configured to receive energy wirelessly, and a signal generator having a signal transmitter configured for transmitting energy to the electrode array from outside an external surface of the patient'"'"'s dura and over the array structure.

60. The system of claim 52, further comprising a signal generator configured for transmitting energy to the electrode array from outside an external surface of a patient'"'"'s dura, and a conductor extendable through the patient'"'"'s dura to couple the generator to the electrode array.

61. The system of claim 60, further comprising a dura-traversing lead fitting configured to form a water-tight closure when the dura is closed around the conductor.

62. The system of claim 52, wherein the circuitry is configured to drive individual electrodes selectively so as to stimulate programmably preselected target regions of the spinal cord.

63. The system of claim 52, wherein the circuitry is adapted to stimulate selectively a region comprising the septomarginal facilicus.

64. The system of claim 52, wherein the array structure further comprises a radio frequency antenna, and the circuitry is configured to receive power and control signals from the antenna and deliver stimulation currents to the electrodes of the electrode array.

65. A method of manufacturing a system configured for treating pain, comprising:

coupling an array structure with an electrical circuitry;

wherein the array structure comprises a compliant backing with a plurality of electrodes supported thereupon so as to form an electrode array along an interior surface of the array structure;

wherein the array structure is configured to conform over a surface of a spinal cord so that the electrodes of the array directly contact the spinal cord; and

whereby the circuitry is coupled with the electrodes so as to deliver electrical stimulation through the electrodes to a targeted sub-region of the spinal cord to relieve pain without stimulating dorsal nerve rootlets.