Directional stimulation lead and orientation system

• US 20050171587A1
• Filed: 11/24/2004
• Published: 08/04/2005
• Est. Priority Date: 11/25/2003
• Status: Active Grant

• Current Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Jones, Tim, Erickson, John H., Franz, Brian, Daglow, Terry, Hooper, Sandy
• Granted Patent: US 8,224,456 B2
• Time in Patent Office: Days
• US Class Current: 607/116
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes

Abstract

A lead, method of manufacturing same, and system for stimulation is provided. The lead includes an insulative member or layer that masks a portion of the electrode(s) to effectively generate a directional lead that focuses or directs the stimulation to desired location(s). In another embodiment, the lead further includes a marking system to allow a clinician to orient the directional lead, as desired, while the lead is within a body.

Claims

1. A lead, comprising:

a lead body having a proximal end and a distal end;

a connector positioned proximate the proximal end;

an electrode positioned proximate the distal end;

an insulative member positioned over the electrode and having an opening therethrough to expose at least a portion of the electrode; and

a marking system on the lead providing a mechanism for determining the orientation of the lead when the lead is implanted in a body.

2. The lead in accordance with claim 1 wherein the marking system comprises a first orientation marker that is radio-opaque.

3. The lead in accordance with claim 1 wherein the marking system comprises a first orientation marker and a second orientation marker that function in combination to provide a mechanism for determining the orientation of the lead.

4. The lead in accordance with claim 1 wherein the insulative member comprises a sleeve placed over the distal end of the lead.

5. The lead in accordance with claim 1 wherein the insulative member comprises a deposited layer of insulative material.

6. The lead in accordance with claim 1 wherein the insulative layer is substantially coextensive with the lead body such that an outer diameter of the lead body is substantially the same as an outer diameter of the insulative layer.

7. A lead, comprising:

a lead body having a proximal end and a distal end;

a connector positioned proximate the proximal end;

an electrode positioned proximate the distal end;

an insulative member positioned over the electrode and having an opening therethrough to expose at least a portion of the electrode; and

means for determining the orientation of an implanted lead.

8. The lead in accordance with claim 7 wherein the means for determining the orientation comprises a marking system having at least one radio-opaque element.

9. The lead in accordance with claim 7 wherein the means for determining the orientation comprises a first orientation marker.

10. The lead in accordance with claim 7 wherein the means for determining the orientation comprises a first orientation marker and a second orientation marker that function in combination to determine the orientation of the lead.

11. The lead in accordance with claim 7 wherein the insulative member comprises a sleeve placed over the distal end of the lead.

12. The lead in accordance with claim 7 wherein the insulative member comprises a deposited layer of insulative material.

13. A system for stimulating a portion of a body, the system comprising:

a source for generating a stimulus; and

an implantable lead for receiving the stimulus from the source, the implantable lead comprising,

a lead body having a proximal end and a distal end,

a connector positioned proximate the proximal end,

an electrode positioned proximate the distal end,

an insulative member positioned over the electrode and having an opening therethrough to expose at least a portion of the electrode, and

a marking system on the lead for determining the orientation of the lead when the lead is implanted in a body.

14. The system in accordance with claim 13 further comprising:

a controller operable for communicating with the source and controlling the source.

15. The system in accordance with claim 13 wherein the source comprises an RF receiver.

16. The system in accordance with claim 13 wherein the source comprises an implantable pulse generator.

17. A system for stimulating a portion of a body, the system comprising:

a source for generating a stimulus; and

an implantable lead for receiving the stimulus from the source, the implantable lead comprising,

a lead body having a proximal end and a distal end,

a connector positioned proximate the proximal end,

an electrode positioned proximate the distal end,

an insulative member positioned over the electrode and having an opening therethrough to expose at least a portion of the electrode, and

means for determining the orientation of the lead when the lead is implanted in a body.

18. The system in accordance with claim 17 further comprising:

a controller operable for communicating with the source and controlling the source.

19. The system in accordance with claim 17 wherein the source comprises an RF receiver.

20. The system in accordance with claim 17 wherein the source comprises an implantable pulse generator.

21. A lead, comprising:

a lead body having a proximal end and a distal end;

a connector positioned proximate the proximal end;

an electrode positioned proximate the distal end; and

a marker positioned proximate the distal end of the lead for determining the orientation of the lead when the lead is implanted in a body.

22. A lead, comprising:

a lead body having a proximal end and a distal end;

a connector positioned proximate the proximal end;

an electrode positioned proximate the distal end;

an insulative member positioned over the electrode and having an opening therethrough to expose at least a portion of the electrode, and wherein the insulative member is substantially coextensive with the lead body such that an outer diameter of the lead body is substantially the same as an outer diameter of the insulative member.

23. The lead in accordance with claim 22 wherein the insulative member comprises a sleeve placed over the distal end of the lead.

24. The lead in accordance with claim 22 wherein the insulative member comprises a deposited layer of insulative material.

25. The lead in accordance with claim 24 wherein the insulative material comprises paralyne.

26. The lead in accordance with claims 23 further comprising:

means, positioned proximate the distal end of the lead, for determining the orientation of the lead when the lead is implanted within a body.

27. A system for stimulating a portion of a body, the system comprising:

a source for generating a stimulus; and

an implantable lead for receiving the stimulus from the source, the implantable lead comprising,

a lead body having a proximal end and a distal end,

a connector positioned proximate the proximal end,

an electrode positioned proximate the distal end, and

an insulative member positioned over the electrode and having an opening therethrough to expose at least a portion of the electrode, and wherein the insulative member is substantially coextensive with the lead body such that an outer diameter of the lead body is substantially the same as an outer diameter of the insulative member.

28. The system in accordance with claim 27 further comprising:

a controller operable for communicating with the source and controlling the source.

29. The system in accordance with claim 27 wherein the source comprises an RF receiver.

30. The system in accordance with claim 27 wherein the source comprises an implantable pulse generator.

31. A method of manufacturing a lead, comprising:

providing a lead body having a proximal end and a distal end having an electrode;

forming an insulative layer over the electrode;

forming an opening through the insulative layer to expose at least a portion of the electrode.

32. The method in accordance with claim 31 wherein the forming an opening through the insulative layer occurs after the insulative layer is formed over the electrode.

33. The method in accordance with claim 31 wherein the insulative layer comprises paralyne.

34. The method in accordance with claim 31 wherein the forming the insulative layer comprises depositing a layer of insulative material.

35. The method in accordance with claim 31 wherein the forming an opening through the insulative layer comprises etching the insulative layer to form the opening.

36. The method in accordance with claim 31 further comprising:

forming a marking system on the lead providing a mechanism for determining the orientation of the lead when the lead is implanted in a body.

37. The method in accordance with claim 31 further comprising:

forming on the lead means for determining the orientation of the lead when the lead is implanted in a body.

38. A lead manufactured in accordance with the method as defined in claim 31.

39. A method of manufacturing a lead, comprising:

providing a lead body having a first diameter, a proximal end, a distal end, and a first insulative layer extending at least substantially the length of the distal end;

removing a portion of the first insulative layer at the distal end thereby leaving a remaining insulative layer, whereby the distal end of the lead body has a second diameter less than the first diameter.

placing an electrode on the remaining insulative layer at the distal end;

forming a second insulative layer over the electrode to form the distal end having a diameter substantially equal to the first diameter; and

forming an opening through the second insulative layer to expose at least a portion of the electrode.

40. The method in accordance with claim 39 wherein the forming an opening through the second insulative layer occurs after the second insulative layer is formed over the electrode.

41. The method in accordance with claim 39 wherein the second insulative layer comprises paralyne.

42. The method in accordance with claim 39 wherein the forming the second insulative layer comprises depositing a layer of insulative material.

43. The method in accordance with claim 39 wherein the forming an opening through the second insulative layer comprises etching the second insulative layer to form the opening.

44. The method in accordance with claim 39 further comprising:

forming a marking system on the lead providing a mechanism for determining the orientation of the lead when the lead is implanted in a body.

45. The method in accordance with claim 39 further comprising:

forming on the lead means for determining the orientation of the lead when the lead is implanted in a body.