Systems and methods for making and using improved contact arrays for electrical stimulation systems

• US 9,561,362 B2
• Filed: 11/06/2015
• Issued: 02/07/2017
• Est. Priority Date: 11/10/2014
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Malinowski, Zdzislaw Bernard
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US14/935,271
• Publication Number:
  US 20160129242A1
• Time in Patent Office: 459 Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: H01R 43/26 for engaging or disengaging the two parts of a coupling device structural association with two-part coupling device H01R13/629

Abstract

A segmented-contact set of a lead includes segmented contacts extending around less than an entire circumference of the lead and not in electrical contact with one another. The segmented-contact set includes first and second segmented contacts that each include a stimulation portion and a retention member. The stimulation portion has a stimulation surface exposed along an outer surface of the lead. The retention member is coupled to the stimulation portion. The stimulation portion and the retention member collectively form a loop of material that extends around a center transverse axis of the lead beneath the outer surface. A first insulating member is disposed between the stimulation portion of the first segmented contact and the retention member of the second segmented contact. A second insulating member is disposed between the stimulation portion of the second segmented contact and the retention member of the first segmented contact.

Claims

1. An electrical stimulation lead comprising:

a lead body with a proximal portion, at least one distal portion, an outer surface, a circumference, and a longitudinal length;

a plurality of contacts disposed along the lead body, the plurality of contacts comprising

a plurality of electrodes disposed along the distal portion of the lead body, and

a plurality of terminals disposed along the proximal portion of the lead body;

at least one segmented-contact set formed from at least some of the plurality of contacts, the at least one segmented-contact set comprising a plurality of segmented contacts that are each at least partially disposed along a particular longitudinal position of the lead and that each extend around less than the entire circumference of the lead body and that are not in electrical contact with one another, each of the plurality of segmented-contact sets comprising a first segmented contact and a second segmented contact, the first segmented contact and the second segmented contact each comprising

a stimulation portion having a stimulation surface exposed along the outer surface of the lead body, and

at least one retention member coupled to the stimulation portion and disposed beneath the outer surface of the lead body,

wherein the stimulation portion and the at least one retention member collectively form a loop of material that extends around a center transverse axis of the lead body;

a first insulating member disposed between the stimulation portion of the first segmented contact and the at least one retention member of the second segmented contact;

a second insulating member disposed between the stimulation portion of the second segmented contact and the at least one retention member of the first segmented contact; and

a plurality of lead conductors electrically coupling the plurality of electrodes to the plurality of terminals.

2. The electrical stimulation lead of claim 1 wherein, for at least one of the at least one segmented-contact set, the loop comprises a first arced portion having a first curvature and a second arced portion having a second curvature that has a different than the first curvature.

3. The electrical stimulation lead of claim 2, wherein the first arced portion is formed along the stimulation portion and the second arced portion is formed along the at least one retention member.

4. The electrical stimulation lead of claim 3, wherein the at least one retention member comprises at least one transition region having a third arced portion that has a different curvature than at least one of the first arced portion or the second arced portion.

5. The electrical stimulation lead of claim 1, wherein the at least one segmented-contact set comprises exactly two segmented contacts.

6. The electrical stimulation lead of claim 1, wherein the at least one segmented-contact set is formed entirely from electrodes of the plurality of electrodes.

7. The electrical stimulation lead of claim 1, wherein the at least one segmented-contact set is formed entirely from terminals of the plurality of terminals.

8. The electrical stimulation lead of claim 1, wherein the at least one segmented-contact set comprises a first segmented-contact set and a second segmented-contact set, wherein the first segmented-contact set is formed entirely from electrodes of the plurality of electrodes, and wherein the second segmented-contact set is formed entirely from terminals of the plurality of terminals.

9. The electrical stimulation lead of claim 1, wherein the at least one segmented-contact set comprises a plurality of segmented-contact sets, the plurality of segmented-contact sets each formed entirely from terminals of the plurality of terminals.

10. The electrical stimulation lead of claim 1, wherein the at least one segmented-contact set comprises a plurality of segmented-contact sets, and wherein each the first insulating member and the second insulating member extend beneath each of the plurality of segmented-contact sets.

11. The electrical stimulation lead of claim 1, wherein the electrical stimulation lead comprises a single proximal portion and a plurality of distal portions, the plurality of distal portions comprising a first distal portion and a second distal portion, and wherein the plurality of electrodes comprises a first electrode array disposed along the first distal portion and a second electrode array disposed along the second distal portion.

12. The electrical stimulation lead of claim 11, wherein the at least one segmented-contact set comprises a first segmented-contact set, a second segmented-contact set, and a third segmented-contact set, wherein the first segmented-contact set is formed entirely from electrodes of the first electrode array, wherein the second segmented-contact set is formed entirely from electrodes of the second electrode array, and wherein the third segmented-contact set is formed entirely from terminals of the plurality of terminals.

13. An electrical stimulation system comprising:

the electrical stimulation lead of claim 1;

a control module electrically coupleable to the plurality of electrodes of the electrical stimulation lead, the control module comprising

a housing, and

an electronic subassembly disposed in the housing; and

a connector for receiving the electrical stimulation lead, the connector comprising

a connector housing defining a port configured and arranged for receiving the proximal portion of the lead body of the electrical stimulation lead, and

a plurality of connector contacts disposed in the connector housing, the plurality of connector contacts configured and arranged to couple to the plurality of terminals of the electrical stimulation lead when the proximal portion of the lead body of the electrical stimulation lead is received by the port.

14. The electrical stimulation system of claim 13, wherein the plurality of connector contacts comprises a plurality of segmented connector contacts, and wherein the electrical stimulation system further comprises an alignment assembly configured and arranged for aligning the first and second segmented contacts of the at least one segmented-contact sets circumferentially with the plurality of segmented connector contacts.

15. A method of forming the electrical stimulation lead of claim 1, the method comprising:

attaching a first conductor of the plurality of lead conductors to the first segmented contact of the at least one segmented-contact set;

attaching a second conductor of the plurality of lead conductors to the second segmented contact of the at least one segmented-contact set;

arranging the first segmented contact and the second segmented contact into the first segmented-contact set with the stimulation portion of the first segmented contact disposed opposite the stimulation portion of the second segmented contact and with the at least one retention member of the first segmented contact facing the at least one retention member of the second segmented contact to form a first retention space defined between the stimulation portion of the first segmented contact and the at least one retention member of the second segmented contact and a second retention space defined between the stimulation portion of the second segmented contact and the at least one retention member of the first segmented contact;

extending the first insulating member through the first retention space of the first segmented-contact set;

extending the second insulating member through the second retention space of the first segmented-contact set;

attaching the first conductor to a first electrode of the plurality of electrodes disposed along the distal portion of the lead body or a first terminal of the plurality of terminals disposed along the proximal portion of the lead body; and

attaching the second conductor to one of a second electrode of the plurality of electrodes disposed along the distal portion of the lead body or a second terminal of the plurality of terminals disposed along the proximal portion of the lead body.

16. The method of claim 15, wherein arranging the first segmented contact and the second segmented contact into the first segmented-contact set comprises arranging a first segmented terminal of the plurality of terminals and a second segmented terminal of the plurality of terminals into a first segmented-terminal set along the proximal portion of the lead body.

17. The method of claim 16, further comprising arranging a third segmented terminal of the plurality of terminals and a fourth segmented terminal of the plurality of terminals into a second segmented-terminal set disposed along the proximal portion of the lead body and longitudinally displaced from the first segmented-terminal set.

18. The method of claim 16, further comprising extending the first insulating member through a third retention space defined along the second segmented-contact set.

19. The method of claim 16, further comprising extending the second insulating member through a fourth retention space defined along the second segmented-contact set.

20. The method of claim 15, wherein arranging the first segmented contact and the second segmented contact into the first segmented-contact set comprises arranging a first segmented electrode of the plurality of electrodes and a second segmented electrode of the plurality of electrodes into a first segmented-electrode set disposed along the at least one distal portion of the lead body.