SYSTEMS AND METHODS FOR MAKING AND USING ELECTRICAL STIMULATION SYSTEMS HAVING MULTI-LEAD-ELEMENT LEAD BODIES

• US 20110230893A1
• Filed: 03/10/2011
• Published: 09/22/2011
• Est. Priority Date: 03/19/2010
• Status: Abandoned Application

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Barker, John Michael
• Application Number:
  US13/044,917
• Publication Number:
  US 20110230893A1
• Time in Patent Office: Days
• US Class Current: 606/129
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36071 Pain

Abstract

A lead for providing electrical stimulation of patient tissue includes a distal lead element and three proximal lead elements. The distal lead element includes at least twenty electrodes and defines a stylet lumen and a plurality of conductive wire lumens having triangular transverse cross-sectional shapes. Each of the three proximal lead elements includes a plurality of terminals and defines a plurality of conductive wire lumens. Each of the conductive wire lumens has a round transverse cross-sectional shape. A junction couples the distal lead element to the proximal lead elements. Conductive wires couple each of the electrodes of the distal lead element to at least one of the terminals of at least one of the proximal lead elements. The conductive wire lumens disposed on the distal lead element are configured and arranged to receive a plurality of the conductive wires.

Claims

1. A lead for providing electrical stimulation of patient tissue, the lead comprising:

a distal lead element having a longitudinal axis, the distal lead element comprising

at least twenty electrodes disposed on the distal lead element,

a stylet lumen extending along at least a portion of the longitudinal axis of the distal lead element, and

a plurality of conductive wire lumens extending along at least a portion of the longitudinal axis of the distal lead element;

three proximal lead elements, each of the three proximal lead elements having a longitudinal axis and comprising

a plurality of terminals disposed on the proximal lead element, and

a plurality of conductive wire lumens extending along at least a portion of the longitudinal axis of the proximal lead element, wherein each of the conductive wire lumens has a round transverse cross-sectional shape;

a junction coupling the distal lead element to the proximal lead elements; and

a plurality of conductive wires coupling each of the plurality of electrodes disposed on the distal lead element to at least one of the plurality of terminals disposed on at least one of the proximal lead elements;

wherein the plurality of conductive wire lumens disposed on the distal lead element are configured and arranged to receive a plurality of the conductive wires.

2. The lead of claim 1, wherein each of the plurality of conductive wire lumens disposed on the distal lead element is configured and arranged to receive three of the conductive wires.

3. The lead of claim 2, wherein each of the three conductive wires extending along a first one of the plurality of conductive wire lumens of the distal lead element couples to one or more terminals disposed on a different one of the three proximal lead elements.

4. The lead of claim 1, wherein for each of the plurality of conductive wires extending along a first one of the plurality of conductive wire lumens of the distal lead element, insulation is disposed around the conductive wire that is visually or texturally distinct from insulation disposed around the remaining conductive wires disposed in the first one of the plurality of conductive wire lumens.

5. The lead of claim 1, wherein each of the proximal lead elements has a visibly different length.

6. The lead of claim 1, wherein for each proximal lead element the length of the proximal lead element correlates to which electrodes the terminals of the proximal lead element are coupled.

7. The lead of claim 1, wherein one of the proximal lead elements is continuous with the distal lead element.

8. An electrical stimulating system comprising:

the lead of claim 1;

at least one control module configured and arranged to electrically couple to each of the proximal lead elements, each of the at least one control module comprising

a housing, and

an electronic subassembly disposed in the housing; and

a connector for receiving at least one of the three proximal lead elements, the connector comprising

a connector housing defining at least one port at a distal end of the connector, the at least one port configured and arranged for receiving at least one of the three proximal lead elements, and

a plurality of connector contacts disposed in the connector housing, the connector contacts configured and arranged to couple to at least one of the plurality of terminals disposed on each of the at least one of the three proximal lead elements.

9. A kit for providing electrical stimulation of patient tissue, the kit comprising:

the lead of claim 1; and

a lead introducer for facilitating insertion of the lead into the patient, the lead introducer comprising

an outer member configured and arranged for insertion into the patient, and

an insertion needle disposed in the outer member, at least a portion of the insertion needle configured and arranged to receive the distal lead element of the lead.

10. The kit of claim 9, wherein at least one of the proximal lead elements defines a stylet lumen that extends along at least a portion of the longitudinal axis of the proximal lead element and that couples with the stylet lumen of the distal lead element.

11. The kit of claim 10, further comprising a stylet for facilitating guidance of the electrodes to a target stimulation region within the patient, the stylet configured and arranged for insertion into the stylet lumen of the distal lead element via the stylet lumen defined in at least one of the proximal lead elements.

12. The kit of claim 9, wherein the outer member is configured and arranged to divide into at least two parts for removal of the outer member from the lead upon insertion of the lead into the patient.

13. The kit of claim 9, wherein the insertion needle defines an open channel configured and arranged to receive at least a portion of the distal lead element of the lead.

14. The kit of claim 9, wherein the insertion needle comprises a plurality of body lead members configured and arranged to at least partially separate from one another upon removal of the outer member.

15. A method for implanting a trial electrical stimulation lead into a patient, the method comprising:

providing an insertion needle disposed in an outer member;

guiding a distal end of the outer member with the insertion needle to a target stimulation region within the patient;

inserting the distal lead element of the lead of claim 1 into at least a portion of the insertion needle;

separating the insertion needle from the lead;

removing the insertion needle from the lead; and

removing the outer member from the patient while leaving the lead within the patient such that the plurality of electrodes are at the target stimulation region;

16. The method of claim 15, wherein removing the outer member from the patient comprises separating the outer member into at least two parts along a length of a lumen of the outer member.

17. The method of claim 15, wherein removing the insertion needle from lead comprises passing the lead laterally through an open channel of the insertion needle.

18. The method of claim 15, wherein removing the insertion needle from the lead comprises at least partially separating at least two of a plurality of body lead members from one another along a longitudinal axis of the insertion needle.

19. The method of claim 15, wherein removing the outer member from the patient comprises rolling up or sliding the outer member proximally along a longitudinal axis of the insertion needle.

20. The method of claim 15, wherein removing the outer member from the patient comprises tearing up the retaining member into a plurality of pieces or splitting the retaining member along a longitudinal axis of the retaining member.