METHODS AND APPARATUS FOR SPINAL CORD STIMULATION USING EXPANDABLE ELECTRODE

• US 20100057178A1
• Filed: 09/11/2009
• Published: 03/04/2010
• Est. Priority Date: 04/18/2006
• Status: Abandoned Application

• Current Assignee: Electrocore, Llc
• Original Assignee: electroCore, Inc.
• Inventors: Simon, Bruce J.
• Application Number:
  US12/557,936
• Publication Number:
  US 20100057178A1
• Time in Patent Office: Days
• US Class Current: 607/117
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2205/054 with electrotherapy
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/40 Applying electric fields by inductive or capacitive coupling microwave apparatus A61N5/00; Applying radio-frequency signals

Abstract

The present invention provides systems, apparatus and methods for selectively applying electrical energy to body tissue. More specifically, systems and methods are provided for introducing a spinal cord stimulation electrode device into a patient'"'"'s epidural space through a small portal, such as a percutaneous penetration, and then expanding the electrode device once inside the epidural space to achieve a larger footprint of contact on the dura. This substantially prevents migration of the electrode within the epidural space and provides for more efficient and effective treatment.

Claims

1. A device for delivering electrical energy to a patient, comprising:

an enclosure having a longitudinal axis and an outer wall being movable between a collapsed configuration for introduction into the patient wherein the outer wall extends laterally outward from the longitudinal axis by a first distance and an expanded configuration for treating the patient wherein the outer wall extends laterally outward from the longitudinal axis by a second distance, wherein the second distance is greater than the first distance;

an electrode coupled to at least a portion of the outer wall of the enclosure; and

a source of electrical energy coupled to the electrode for delivering an electrical impulse to the electrode in the expanded configuration.

2. The device of claim 1 wherein the enclosure comprises an outer wall defining an interior, the device further comprising a fluid passage coupled to the interior of the electrode and a source of fluid for delivering a fluid into the interior of the enclosure and expanding the outer wall into the expanded configuration.

3. The device of claim 1 wherein the outer wall of the enclosure has a larger surface area for contacting tissue in the expanded configuration.

4. The device of claim 1 wherein the outer wall of the enclosure is the electrode.

5. The device of claim 1 wherein a portion of the outer wall of the enclosure is the electrode.

6. The device of claim 1 wherein the electrode is housed within the enclosure and electrically coupled to the outer wall.

7. The device of claim 6 wherein the electrode is spaced from the outer wall and electrically coupled to the outer wall by an electrically conductive fluid.

8. The device of claim 1 wherein the outer wall expands laterally outward in first and second directions from the longitudinal axis in the expanded configuration.

9. The device of claim 8 wherein the outer wall forms a substantially planar surface extending in opposite directions from the longitudinal axis in the expanded configuration.

10. The device of claim 1 wherein the outer wall forms first and second contact surfaces extending laterally outward from the longitudinal axis in the expanded configuration, wherein the electrode forms part of the first contact surface and the second contact surface comprises an insulating material.

11. The device of claim 10 wherein the first and second contact surfaces are on opposite sides of the outer wall in the expanded configuration.

12. The device of claim 1 wherein the enclosure and the electrode are sized and shaped in the collapsed configuration for a percutaneous penetration into an epidural space of a patient.

13. The device of claim 1 wherein the source of electrical energy is an electrical signal generator operating to apply at least one electrical signal to the electrode such that, when the enclosure is positioned in a spinal cord of the patient, an electro-magnetic field emanates from the electrode to at least one of nerves and muscles in a vicinity of the spinal cord.

14. The device of claim 13 wherein the electrical signal generator operates such that the at least one electrical signal is of a frequency between about 1 Hz to 3000 Hz, a pulse duration of between about 10-1000 us, and an amplitude of between about 1-20 volts.

15. A method for treating an ailment in a patient comprising:

introducing an enclosure through a percutaneous penetration of a patient to a target location adjacent to or near a spine of the patient, the enclosure having a longitudinal axis;

expanding an outer wall of the enclosure in a lateral direction from the longitudinal axis;

contacting a tissue of the patient at the target location with at least a portion of the outer wall; and

applying electrical energy to an electrode coupled to the portion of the outer wall to modulate one or more nerves within the spine of the patient.

16. The method of claim 15 wherein the expanding step is carried out by delivering a fluid into the enclosure.

17. The method of claim 15 wherein at least a portion of the outer wall defines the electrode.

18. The method of claim 15 wherein the electrode is housed within the enclosure and spaced from the outer wall, the method further comprising coupling the electrode to the outer wall by delivering an electrically conductive fluid into an interior of the enclosure.

19. The method of claim 15 wherein the expanding step comprises expanding the outer wall in at least two directions from the lateral axis.

20. The method of claim 15 wherein the expanding step comprises forming a substantially planar contact surface with the outer wall of the enclosure, the planar contact surface having a larger surface area than a diameter of the percutaneous penetration in the patient.

21. The method of claim 20 wherein at least a portion of the substantially planar contact surface comprises the electrode.

22. The method of claim 20 further comprising insulating a surface of the outer wall opposite the substantially planar contact surface.

23. The method of claim 15 wherein the applying step is carried out by applying at least one electrical impulse to the electrode such that an electro-magnetic field emanates from the electrode to at least one of nerves and muscles within the spine of the patient.

24. The method of claim 15, further comprising contacting a return electrode to an external portion of the patient and emanating an electro-magnetic field from the electrode through the tissue in a substantially radial pattern.

25. The method of claim 15 wherein the applying step comprises applying an electrical impulse to a sympathetic nerve chain of a patient to modulate nerve signals thereof such that intestinal peristalsis function within the patient is at least partially improved.

26. The method of claim 15 wherein the applying step is carried out by applying an electrical signal to the electrode of a frequency between about 10 Hz to 200 Hz, a pulse duration of between about 20-400 us, and an amplitude of between about 1-20 volts.

27. The method of claim 26 wherein the frequency is between about 25 to 50 Hz.

28. The method of claim 15 wherein the applying step is carried out by applying an electrical impulse to the electrode sufficient to increase an intestinal motility of the patient.

29. The method of claim 15 wherein the applying step is carried out by applying an electrical impulse to the electrode sufficient to increase a gastric motility of the patient.

30. The method of claim 15 wherein the applying step is carried out by applying an electrical impulse to the electrode sufficient to treat pain.

31. The method of claim 30 wherein the pain is visceral pain associated with irritable bowel syndrome.

32. A method for treating a temporary arrest of intestinal peristalsis in a patient comprising:

introducing an electrode to a target location adjacent to or near a spine of the patient;

expanding the electrode in a lateral direction relative to a longitudinal axis of the electrode; and

applying an electrical impulse to the electrode sufficient to increase intestinal motility of the patient.

33. The method of claim 32 wherein the electrical impulse has a frequency of about 25 Hz to 50 Hz, a pulse width of about 100 to 1000 us and an amplitude of about 0.2 to 20 volts.

34. The method of claim 32 wherein the introducing step comprises advancing the electrode through a percutaneous penetration in the patient and wherein the electrode is expanded in a lateral direction relative to the percutaneous penetration.

35. The method of claim 32 wherein the electrical impulse is sufficient to modulate one or more sympathetic nerves in the patient.