Electrical stimulation system including a device for partially shielding electrical energy emitted from one or more electrical stimulation leads implanted in a human's body

• US 20050137668A1
• Filed: 09/24/2004
• Published: 06/23/2005
• Est. Priority Date: 09/26/2003
• Status: Active Grant

• Current Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories)
• Inventors: Khan, Yasin N.
• Granted Patent: US 7,392,093 B2
• Time in Patent Office: Days
• US Class Current: 607/118
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/3718 Monitoring of or protection against external electromagnetic fields or currents

Abstract

In one embodiment, a device is provided for partially shielding electrical energy emitted from an electrical stimulation lead implanted in a human'"'"'s body to enable stimulation of the human'"'"'s nerve tissue, the lead including one or more electrodes operable to stimulate the nerve tissue. The device includes an anterior concave surface adapted to contact and at least partially surround a posterior side of the lead such that the lead is positioned between the anterior concave surface and the nerve tissue when the device and the lead are implanted in the body. The device includes a posterior convex surface coupled to the anterior concave surface and adapted to contact the body tissue opposite the nerve tissue. The device is adapted to partially shield electrical energy emitted from one or more electrodes on a posterior side of the lead when the device and the lead are implanted in the body to reduce a quantity of electrical energy reaching the body tissue opposite the nerve tissue.

Claims

1. A device for partially shielding electrical energy emitted from an electrical stimulation lead implanted in a human'"'"'s body to enable stimulation of the human'"'"'s nerve tissue, the electrical stimulation lead comprising one or more electrodes operable to stimulate the human'"'"'s nerve tissue, the device comprising:

an anterior concave surface adapted to contact and at least partially surround a posterior side of the electrical stimulation lead such that the electrical stimulation lead is positioned between the anterior concave surface of the device and the human'"'"'s nerve tissue when the device and the electrical stimulation lead are implanted in the human'"'"'s body; and

a posterior convex surface coupled to the anterior concave surface and adapted to contact the human'"'"'s body tissue opposite the human'"'"'s nerve tissue;

the device adapted to partially shield electrical energy emitted from one or more electrodes on a posterior side of the electrical stimulation lead when the device and the electrical stimulation lead are implanted in the human'"'"'s body to reduce a quantity of electrical energy reaching the human'"'"'s body tissue opposite the human'"'"'s nerve tissue.

2. The device of claim 1, configured to stabilize the electrical stimulation lead in position when the anterior concave surface is positioned proximate the electrical stimulation lead in the human'"'"'s body.

3. The device of claim 1, wherein the electrical stimulation lead comprises a percutaneous lead comprising circumferential electrodes.

4. The device of claim 1, further comprising a second anterior concave surface adapted to contact and at least partially surround a posterior side of a second electrical stimulation lead such that the second electrical stimulation lead is positioned between the anterior concave surface of the device and the human'"'"'s nerve tissue when the device, the electrical stimulation lead, and the second electrical stimulation lead are implanted in the human'"'"'s body.

5. The device of claim 4, further comprising a lobe separating the electrical stimulation lead and the second electrical stimulation lead.

6. The device of claim 1, wherein the anterior concave and posterior convex surfaces of the device define a solid interior between the anterior concave and posterior convex surfaces.

7. The device of claim 6, wherein the anterior concave and posterior convex surfaces of the device define a collapsible cavity between the anterior concave and posterior convex surfaces, the collapsible cavity allowing the device to be more easily removed from the human'"'"'s body.

8. The device of claim 1, wherein the device is formed from polyurethane.

9. The device of claim 1, wherein the electrical stimulation lead is implanted in the human'"'"'s epidural space, the human'"'"'s nerve tissue comprises spinal nerve tissue, and the human'"'"'s body tissue opposite the human'"'"'s nerve tissue comprises the human'"'"'s ligamentum flavum.

10. The device of claim 1, wherein the human'"'"'s nerve tissue comprises peripheral nerve tissue.

15. The device of claim 1, further comprising a second anterior concave surface adapted to contact and at least partially surround a posterior side of a second electrical stimulation lead such that the second electrical stimulation lead is positioned between the anterior concave surface of the device and the human'"'"'s nerve tissue when the device, the electrical stimulation lead, and the second electrical stimulation lead are implanted in the human'"'"'s body.

16. The device of claim 15, further comprising a lobe separating the electrical stimulation lead and the second electrical stimulation lead.

20. The device of claim 1, wherein the electrical stimulation lead is implanted in the human'"'"'s epidural space, the human'"'"'s nerve tissue comprises spinal nerve tissue, and the human'"'"'s body tissue opposite the human'"'"'s nerve tissue comprises the human'"'"'s ligamentum flavum.

21. The device of claim 1, wherein the human'"'"'s nerve tissue comprises peripheral nerve tissue.

27. The device of claim 1, further comprising a second anterior concave surface adapted to contact and at least partially surround a posterior side of a second electrical stimulation lead such that the second electrical stimulation lead is positioned between the anterior concave surface of the device and the human'"'"'s nerve tissue when the device, the electrical stimulation lead, and the second electrical stimulation lead are implanted in the human'"'"'s body.

28. The device of claim 27, further comprising a lobe separating the electrical stimulation lead and the second electrical stimulation lead.

38. The device of claim 1, further comprising a second anterior concave surface adapted to contact and at least partially surround a posterior side of a second electrical stimulation lead such that the second electrical stimulation lead is positioned between the anterior concave surface of the device and the human'"'"'s nerve tissue when the device, the electrical stimulation lead, and the second electrical stimulation lead are implanted in the human'"'"'s body.

39. The device of claim 38, further comprising a lobe separating the electrical stimulation lead and the second electrical stimulation lead.

11. A method of partially shielding electrical energy emitted from an electrical stimulation lead implanted in a human'"'"'s body to enable stimulation of the human'"'"'s nerve tissue, the electrical stimulation lead comprising one or more electrodes operable to stimulate the human'"'"'s nerve tissue, the method comprising:

inserting into the human'"'"'s body in proximity with the electrical stimulation lead a device comprising;

an anterior concave surface adapted to contact and at least partially surround a posterior side of the electrical stimulation lead such that the electrical stimulation lead is positioned between the anterior concave surface of the device and the human'"'"'s nerve tissue when the device and the electrical stimulation lead are implanted in the human'"'"'s body; and

a posterior convex surface coupled to the anterior concave surface and adapted to contact the human'"'"'s body tissue opposite the human'"'"'s nerve tissue;

the device adapted to partially shield electrical energy emitted from one or more electrodes on a posterior side of the electrical stimulation lead when the device and the electrical stimulation lead are implanted in the human'"'"'s body to reduce a quantity of electrical energy reaching the human'"'"'s body tissue opposite the human'"'"'s nerve tissue;

emitting electrical energy using the electrical stimulation lead to stimulate the human'"'"'s nerve tissue; and

using the device to partially shield the electrical energy emitted from the electrical stimulation lead from reaching the human'"'"'s body tissue opposite the human'"'"'s nerve tissue.

12. The method of claim 11, wherein the device is inserted substantially simultaneously with the electrical stimulation lead through a needle.

13. The method of claim 11, wherein the device is configured to stabilize the electrical stimulation lead in position when the anterior concave surface is positioned proximate the electrical stimulation lead in the human'"'"'s body.

14. The method of claim 11, wherein the electrical stimulation lead comprises a percutaneous lead having circumferential electrodes.

17. The method of claim 11, wherein the anterior concave and posterior convex surfaces of the device define a solid interior between the anterior concave and posterior convex surfaces.

18. The method of claim 17, wherein the anterior concave and posterior convex surfaces of the device define a collapsible cavity between the anterior concave and posterior convex surfaces, the collapsible cavity allowing the device to be more easily removed from the human'"'"'s body.

19. The method of claim 13, wherein the device is formed from polyurethane.

22. An electrical stimulation system for stimulating a human'"'"'s nerve tissue while partially shielding the human'"'"'s body tissue opposite the human'"'"'s nerve tissue from electrical energy emitted from an electrical stimulation lead implanted in the human'"'"'s body to enable stimulation of the human'"'"'s nerve tissue, the electrical stimulation lead comprising one or more electrodes operable to stimulate the human'"'"'s nerve tissue, the system comprising:

an electrical stimulation lead;

a device comprising;

an anterior concave surface adapted to contact and at least partially surround a posterior side of the electrical stimulation lead such that the electrical stimulation lead is positioned between the anterior concave surface of the device and the human'"'"'s nerve tissue when the device and the electrical stimulation lead are implanted in the human'"'"'s body; and

a posterior convex surface coupled to the anterior concave surface and adapted to contact the human'"'"'s body tissue opposite the human'"'"'s nerve tissue;

the device adapted to partially shield electrical energy emitted from one or more electrodes on a posterior side of the electrical stimulation lead when the device and the electrical stimulation lead are implanted in the human'"'"'s body to reduce a quantity of electrical energy reaching the human'"'"'s body tissue opposite the human'"'"'s nerve tissue; and

an implantable generator operable to power the electrical stimulation lead for stimulation of the human'"'"'s nerve tissue.

23. The system of claim 22, wherein the nerve tissue to be stimulated comprises spinal nerve tissue.

24. The system of claim 22, wherein the nerve tissue to be stimulated comprises peripheral nerve tissue.

25. The system of claim 22, wherein the device is configured to stabilize the electrical stimulation lead in position when the anterior concave surface is positioned proximate the electrical stimulation lead in the human'"'"'s body.

26. The system of claim 22, wherein the electrical stimulation lead comprises a percutaneous lead comprising circumferential electrodes.

29. The device of claim 22, wherein the anterior concave and posterior convex surfaces of the device define a solid interior between the anterior concave and posterior convex surfaces.

30. The system of claim 29, wherein the anterior concave and posterior convex surfaces of the device define a collapsible cavity between the anterior concave and posterior convex surfaces, the collapsible cavity allowing the device to be more easily removed from the human'"'"'s body.

31. The system of claim 22, wherein the device is formed from polyurethane.

32. A method of implanting an electrical stimulation system for stimulating a human'"'"'s nerve tissue while partially shielding electrical energy emitted from an electrical stimulation lead implanted in the human'"'"'s body to enable stimulation of the human'"'"'s nerve tissue, the electrical stimulation lead comprising one or more electrodes operable to stimulate the human'"'"'s nerve tissue, the method comprising:

inserting into the user'"'"'s body an introducer;

inserting into the user'"'"'s body through the introducer an electrical stimulation lead and positioning the electrical stimulation lead proximate the human'"'"'s nerve tissue;

inserting into the user'"'"'s body through the introducer a device comprising the following and positioning the device proximate the electrical stimulation lead;

an anterior concave surface adapted to contact and at least partially surround a posterior side of the electrical stimulation lead such that the electrical stimulation lead is positioned between the anterior concave surface of the device and the human'"'"'s nerve tissue when the device and the electrical stimulation lead are implanted in the human'"'"'s body; and

a posterior convex surface coupled to the anterior concave surface and adapted to contact the human'"'"'s body tissue opposite the human'"'"'s nerve tissue;

the device adapted to partially shield electrical energy emitted from one or more electrodes on a posterior side of the electrical stimulation lead when the device and the electrical stimulation lead are implanted in the human'"'"'s body to reduce a quantity of electrical energy reaching the human'"'"'s body tissue opposite the human'"'"'s nerve tissue; and

inserting an implantable generator operable to power the electrical stimulation lead for stimulation of the human'"'"'s nerve tissue.

33. The system of claim 32, wherein the nerve tissue to be stimulated comprises spinal nerve tissue.

34. The system of claim 32, wherein the nerve tissue to be stimulated comprises peripheral nerve tissue.

35. The method of claim 32, wherein the device is inserted substantially simultaneously with the electrical stimulation lead through a needle.

36. The method of claim 32, wherein the device is configured to stabilize the electrical stimulation lead in position when the anterior concave surface is positioned proximate the electrical stimulation in the human'"'"'s body.

37. The method of claim 32, wherein the electrical stimulation lead comprises a percutaneous lead comprising circumferential electrodes.

40. The method of claim 32, wherein the anterior concave and posterior convex surfaces of the device define a solid interior between the anterior concave and posterior convex surfaces.

41. The method of claim 40, wherein the anterior concave and posterior convex surfaces of the device define a collapsible cavity between the anterior concave and posterior convex surfaces, the collapsible cavity allowing the device to be more easily removed from the human'"'"'s body.

42. The method of claim 32, wherein the device is formed from polyurethane.