Furcated sensing and stimulation lead

• US 6,597,953 B2
• Filed: 02/20/2001
• Issued: 07/22/2003
• Est. Priority Date: 02/20/2001
• Status: Expired due to Term

• Current Assignee: Neuropace Inc.
• Original Assignee: Neuropace Inc.
• Inventors: Boling, C. Lance
• Primary Examiner(s): Basichas, Alfred
• Application Number:
  US09/789,171
• Publication Number:
  US 20020116042A1
• Time in Patent Office: 882 Days
• Field of Search: 607/45, 607/122, 607/46, 600/554
• US Class Current: 607/45
• CPC Class Codes: A61N 1/0531 Brain cortex electrodes
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole

Abstract

A furcated medical electrical lead for neurological applications has a distal portion having a plurality of distal end segments, each of which bears at least one distal electrode for electrographic sensing or electrical stimulation. The furcated configuration allows each distal end segment to be implanted in a different site in the patient'"'"'s brain. In contrast to surface strip or grid electrodes, shallow implantation reduces the probability that any of the electrodes will move away from the surface of the brain due to atrophy or other phenomena.

Claims

1. A furcated medical electrical lead adapted to be at least partially implanted in a human patient, the lead comprising:

a proximal portion having a lead connection area;

a furcated distal portion having a plurality of separate distal end segments;

a body interconnecting the proximal portion and the distal portion; and

a reinforced integral junction structure situated between and interconnecting the body and the distal portion, wherein the junction structure includes at least one internal reinforcing member,

wherein each of the separate distal end segments comprises at least one electrode in communication with the lead connection area of the proximal portion.

2. The furcated medical electrical lead of claim 1, wherein the reinforcing member comprises a polymer sheet or web.

3. The furcated medical electrical lead of claim 1, wherein the reinforcing member comprises at least one fiber extending from the body, through the junction structure, and into a distal end segment.

4. The furcated medical electrical lead of claim 1, wherein the reinforcing member comprises at least one metallic structure extending from the body, through the junction structure, and into a distal end segment.

5. The furcated medical electrical lead of claim 4, wherein the metallic structure is configured to bias the plurality of distal end segments into a preferred configuration.

6. The furcated medical electrical lead of claim 1, wherein the junction structure comprises a molded structure integral with the body and the distal end segments.

7. The furcated medical electrical lead of claim 1, wherein the junction structure comprises a prefabricated boot structure configured to receive the body and the distal end segments.

8. The furcated medical electrical lead of claim 1, wherein:

at least one of the distal end segments defines a longitudinal lumen; and

wherein the junction structure defines at least one aperture providing stylet access to the longitudinal lumen.

9. The furcated medical electrical lead of claim 8, wherein the aperture is formed as a fluid-resistant septum.

10. The furcated medical electrical lead of claim 1, wherein the body has a diameter between approximately 0.75 mm and approximately 1.5 mm.

11. The furcated medical electrical lead of claim 1, wherein at least one of the distal end segments has a diameter between approximately 0.3 mm and approximately 1.0 mm.

12. The furcated medical electrical lead of claim 1 wherein the body has a diameter and a first distal end segment of the plurality of distal end segments has a diameter, and wherein the diameter of the body is greater than the diameter of the first distal end segment.

13. The furcated medical electrical lead of claim 1, wherein the lead connection area comprises a plurality of inline circumferential terminal rings.

14. The furcated medical electrical lead of claim 1, wherein the lead connection area comprises a furcated structure having a plurality of lead connection members.

15. The furcated medical electrical lead of claim 1, further comprising a conductor connecting the cortical electrode to the lead connection area.

16. The furcated medical electrical lead of claim 15, wherein the conductor is disposed longitudinally within the body and the distal end segment.

17. The furcated medical electrical lead of claim 15, wherein the conductor is arranged in a helical coil within the body and the distal end segment.

18. The furcated medical electrical lead of claim 15, wherein the conductor is arranged in a helical coil within the body and longitudinally in the distal end segment.

19. The furcated medical electrical lead of claim 1, wherein each of the distal end segment further comprises a flexible biocompatible shaft defining a lumen, a relatively rigid tip, and at least one biocompatible conductive electrode.

20. The furcated medical electrical lead of claim 19, wherein the biocompatible conductive electrode comprises a circumferential biocompatible metallic ring.

21. The furcated medical electrical least of claim 19, wherein the biocompatible conductive electrode is fabricated from platinum or a platinum-iridium alloy.

22. The furcated medical electrical lead of claim 19, wherein the biocompatible conductive electrode has a surface area between approximately 0.75 mm² and approximately 15 mm².

23. The furcated medical electrical lead of claim 1, wherein one of the distal end segments further comprises a rigidity enhancing tube disposed within at least a portion of the distal end segment.

24. The furcated medical electrical lead of claim 1, wherein the distal end segments are prearranged in a flat fan pattern.

25. The furcated medical electrical lead of claim 1, wherein the distal end segments are arranged in a three-dimensional radial pattern.

26. The furcated medical electrical lead of claim 1, wherein the distal end segments are arranged in an asymmetric rake pattern.

27. The furcated medical electrical lead of claim 1, wherein at least one of the separate distal end segments further comprises a sensor.

28. A method for using a furcated medical electrical lead in conjunction with a neurological diagnostic or treatment apparatus, wherein the lead has a distal portion with a plurality of separate distal end segments, the method comprising the steps of:

accessing a patient'"'"'s cortex by forming an opening in the patient'"'"'s cranium;

selecting a plurality of electrode sites in the patient'"'"'s cortex corresponding to the plurality of distal end segments;

passing the distal portion of the lead through the opening in the patient'"'"'s cranium;

inserting the plurality of distal end segments into the respective plurality of electrode sites by manipulating the distal end segments with a stylet; and

connecting the lead to the neurological diagnostic or treatment apparatus via a lead connection area at a proximal portion of the lead.

29. The method for using a furcated medical electrical lead of claim 28, wherein the neurological diagnostic or treatment apparatus comprises a neurostimulator, an electrographic recorder, or an electrographic analysis unit.

30. The method for using a furcated medical electrical lead of claim 29, wherein the neurological diagnostic or treatment apparatus is an implanted device.

31. The method for using a furcated medical electrical lead of claim 30, wherein the implanted device is implanted intracranially.

32. The method for using a furcated medical electrical lead of claim 28, wherein the step of inserting the plurality of separate distal end segments comprises the steps of:

placing the stylet into a desired distal end segment;

manipulating the stylet and the desired distal end segment to insert the distal end segment into an electrode site;

removing the stylet from the desired distal end segment; and

repeating the placing, manipulating, and removing steps for each of the separate distal end segments.

33. The method for using a furcated medical electrical lead of claim 28, further comprising the step of anchoring the furcated medical electrical lead to the patient'"'"'s cranium.

34. The method for using a furcated medical electrical lead of claim 28, further comprising the step of routing the lead under the patient'"'"'s scalp.

35. The method for using a furcated medical electrical lead of claim 28, wherein at least one electrode site is near a surface region of the patient'"'"'s brain.

36. The method for using a furcated medical electrical lead of claim 28, wherein at least one electrode site is within a deep region of the patient'"'"'s brain.