Electrode assemblies, methods, and components thereof for implantable medical electrical leads

• US 10,449,353 B2
• Filed: 04/21/2017
• Issued: 10/22/2019
• Est. Priority Date: 04/28/2016
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Shoberg, Bret R., Boser, Gregory A., Hegland, Michael T., Olson, Robert L., Seeley, Dale F., Silverberg, Jacob W., Rama, Suraj
• Primary Examiner(s): Wehrheim, Lindsey G
• Application Number:
  US15/493,932
• Publication Number:
  US 20170312500A1
• Time in Patent Office: 914 Days
• 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: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: H01R 2107/00 Four or more poles
• CPC Class Codes: H01R 2201/12 for medicine and surgery
• CPC Class Codes: H01R 24/58 Contacts spaced along longitudinal axis of engagement

Abstract

An implantable medical electrical lead includes an electrode assembly in which an electrical junction between a first conductor and an inner surface of a first electrode of the assembly is wedged within a first channel of at least one core member of the assembly, around which the first electrode extends. The at least one core member is formed from an insulating material, and the first channel may be one of a plurality of longitudinally extending channels arrayed around a circumference of a central lumen of the assembly, which is defined by the at least one core member. The first conductor extends along a length of the assembly, for example, defined between the first electrode and a second electrode thereof, in a helical path that travels around the central lumen.

Claims

1. An electrode assembly for an implantable medical electrical lead, the assembly comprising:

at least one core member formed from an insulating material, the at least one core member defining a central longitudinally extending lumen of the assembly, and each of the at least one core member including a plurality of longitudinally extending channels arrayed around a circumference of the central lumen, each channel having an opening that extends along an entire length thereof;

a plurality of electrodes spaced apart from one another along a length of the assembly, a first electrode of the plurality defining a distal end of the length, and a second electrode of the plurality defining a proximal end of the length, the first electrode extending around the at least one core member;

a plurality of elongate conductors corresponding to the plurality of electrodes, a first conductor of the plurality of conductors extending along a helical path, the helical path traveling from the proximal end of the length of the assembly to the distal end of the length of the assembly and around the central lumen of the assembly; and

an electrical junction between the first conductor and an inner surface of the first electrode, the junction being wedged within a first channel of the plurality of channels of the at least one core member.

2. The assembly of claim 1, wherein the length thereof is between approximately 1 inch and approximately 3 inches, and the helical path travels approximately 360 degrees around the central lumen every 1 inch.

3. The assembly of claim 1, wherein the opening of each channel of the plurality of channels of the at least one core member faces outward, away from the central lumen.

4. The assembly of claim 1, wherein the electrical junction comprises a conductive sleeve swaged around a distal end of the first conductor, and a weld joint formed between the inner surface of the first electrode and the swaged conductive sleeve.

5. The assembly of claim 1, further comprising another, second electrical junction between a second conductor of the plurality of conductors and an inner surface of the second electrode, and wherein:

the at least one core member comprises a single flexible core member extending along the length of the assembly;

each channel of the plurality of channels of the single core member extends along a corresponding helical path that travels around the central lumen;

the first conductor extends within the first channel along the length of the assembly;

the second electrode extends around the single core member; and

the second electrical junction is wedged within a second channel of the plurality of channels.

6. The assembly of claim 5, further comprising another, third electrical junction between a third conductor of the plurality of conductors and an inner surface of a third electrode of the plurality of electrodes, the third electrode extending around the core member, between the first electrode and the second electrode;

and wherein;

the third conductor extends within a third channel of the plurality of channels of the single core member, and along the helical path thereof; and

the third electrical junction is wedged within the third channel.

7. The assembly of claim 6, wherein each electrical junction comprises a conductive sleeve swaged around a distal end of the corresponding conductor and a weld joint formed between the inner surface of the corresponding electrode and the corresponding swaged conductive sleeve.

8. The assembly of claim 5, wherein the central lumen defined by the single core member has a lubricious surface.

9. The assembly of claim 1, wherein:

the at least one core member comprises a plurality of core members spaced apart from one another along the length of the assembly, a first core member of the plurality of core members including the first channel in which the electrical junction between the first conductor and the inner surface of the first electrode is wedged;

each electrode of the plurality of electrodes extends around a corresponding core member; and

the first conductor extends in a corresponding channel of each of the plurality of core members.

10. The assembly of claim 9, further comprising another, second electrical junction between a second conductor of the plurality of conductors and an inner surface of the second electrode, the second electrode extending around a second core member of the plurality of core members, and the second electrical junction being wedged within a channel of the second core member, the channel in which the second electrical junction is wedged being separate from the channel of the second core member in which the first conductor extends.

11. The assembly of claim 10, further comprising a third electrical junction between a third conductor of the plurality of conductors and an inner surface of a third electrode of the plurality of electrodes, the third electrode extending around a third core member of the plurality of core members and being located between the first electrode and the second electrode;

and wherein;

the third conductor extends within another channel of the second core member, the other channel being separate from the channel in which the first conductor extends and separate from the channel in which the second electrical junction is wedged; and

the third electrical junction is wedged within a channel of the third core member, the channel in which the third electrical junction is wedged being separate from the channel of the third core member in which the first conductor extends.

12. The assembly of claim 11, wherein each electrical junction comprises a conductive sleeve swaged around a distal end of the corresponding conductor and a weld joint formed between the inner surface of the corresponding electrode and the corresponding swaged conductive sleeve.

13. The assembly of claim 9, wherein the opening of each channel of the plurality of channels of each core member faces inward toward the central lumen.

14. The assembly of claim 13, further comprising an elongate tubular sidewall extending along the length of the assembly to isolate the channels of the plurality of core members from the central lumen.

15. An implantable medical electrical lead comprising a connector, an electrode assembly, and an insulative body extending between the connector and the electrode assembly;

and wherein the electrode assembly comprises;

at least one core member formed from an insulating material, the at least one core member defining a central longitudinally extending lumen of the assembly, and each of the at least one core member including a plurality of longitudinally extending channels arrayed around a circumference of the central lumen, each channel having an opening that extends along an entire length thereof;

a plurality of electrodes spaced apart from one another along a length of the assembly, a first electrode of the plurality defining a distal end of the length, and a second electrode of the plurality defining a proximal end of the length, the first electrode extending around the at least one core member;

a plurality of elongate conductors corresponding to the plurality of electrodes, each conductor extending proximally from the electrode assembly, within the body, to the connector and being electrically coupled to the connector, a first conductor of the plurality of conductors extending along a helical path, the helical path traveling from the proximal end of the length of the assembly to the distal end of the length of the assembly and around the central lumen of the assembly; and

an electrical junction between the first conductor and an inner surface of the first electrode, the junction being wedged within a first channel of the plurality of channels of the at least one core member.

16. The lead of claim 15, further comprising a distal-most tip located in close proximity to the distal end of the length of the electrode assembly;

and wherein the electrode assembly further comprises a spacer located between adjacent electrodes of the plurality of electrodes, the distal-most tip of the lead and each spacer being integrally molded together from an insulative material.

17. The lead of claim 15, further comprising an elongate inner coil extending within the connector and the insulative body, and within the central lumen of the electrode assembly.

18. The lead of claim 15, wherein the length of the electrode assembly is between approximately 1 inch and approximately 3 inches, and the helical path of the assembly travels approximately 360 degrees around the central lumen every 1 inch.

19. The lead of claim 15, wherein the opening of each channel of the plurality of channels of the at least one core member of the electrode assembly faces outward, away from the central lumen.

20. The lead of claim 15, wherein the electrical junction of the electrode assembly comprises a conductive sleeve swaged around a distal end of the first conductor, and a weld joint formed between the inner surface of the first electrode and the swaged conductive sleeve.

21. The lead of claim 15, wherein the electrode assembly further comprises another, second electrical junction between a second conductor of the plurality of conductors and an inner surface of the second electrode, and wherein:

the at least one core member comprises a single flexible core member extending along the length of the assembly;

each channel of the plurality of channels of the single core member extends along a corresponding helical path that travels around the central lumen;

the first conductor extends within the first channel along the length of the assembly;

the second electrode extends around the single core member; and

the second electrical junction is wedged within a second channel of the plurality of channels.

22. The lead of claim 21, wherein the electrode assembly further comprises another, third electrical junction between a third conductor of the plurality of conductors and an inner surface of a third electrode of the plurality of electrodes, the third electrode extending around the core member, between the first electrode and the second electrode;

and wherein;

the third conductor extends within a third channel of the plurality of channels of the single core member, and along the helical path thereof; and

the third electrical junction is wedged within the third channel.

23. The lead of claim 22, wherein each electrical junction of the electrode assembly comprises a conductive sleeve swaged around a distal end of the corresponding conductor and a weld joint formed between the inner surface of the corresponding electrode and the corresponding swaged conductive sleeve.

24. The lead of claim 21, wherein the central lumen defined by the single core member has a lubricious surface.

25. The lead of claim 15, wherein:

the at least one core member of the electrode assembly comprises a plurality of core members spaced apart from one another along the length of the assembly, a first core member of the plurality of core members including the first channel in which the electrical junction between the first conductor and the inner surface of the first electrode is wedged;

each electrode of the plurality of electrodes of the electrode assembly extends around a corresponding core member; and

the first conductor of the electrode assembly extends in a corresponding channel of each of the plurality of core members.

26. The lead of claim 25, wherein the electrode assembly further comprises another, second electrical junction between a second conductor of the plurality of conductors and an inner surface of the second electrode, the second electrode extending around a second core member of the plurality of core members, and the second electrical junction being wedged within a channel of the second core member, the channel in which the second electrical junction is wedged being separate from the channel of the second core member in which the first conductor extends.

27. The lead of claim 26, wherein the electrode assembly further comprises a third electrical junction between a third conductor of the plurality of conductors and an inner surface of a third electrode of the plurality of electrodes, the third electrode extending around a third core member of the plurality of core members and being located between the first electrode and the second electrode;

and wherein;

the third conductor extends within another channel of the second core member, the other channel being separate from the channel in which the first conductor extends and separate from the channel in which the second electrical junction is wedged; and

the third electrical junction is wedged within a channel of the third core member, the channel in which the third electrical junction is wedged being separate from the channel of the third core member in which the first conductor extends.

28. The lead of claim 27, wherein each electrical junction of the electrode assembly comprises a conductive sleeve swaged around a distal end of the corresponding conductor and a weld joint formed between the inner surface of the corresponding electrode and the corresponding swaged conductive sleeve.

29. The lead of claim 25, wherein the opening of each channel of the plurality of channels of each core member of the electrode assembly faces inward toward the central lumen.

30. The lead of claim 29, wherein the electrode assembly further comprises an elongate tubular sidewall extending along the length of the assembly to isolate the channels of the plurality of core members from the central lumen.

31. An electrode component for an electrode assembly of an implantable medical electrical lead, the component comprising:

a core formed from an insulating material and defining a central longitudinally extending lumen of the component, the core including a plurality of longitudinally extending channels arrayed around the central lumen, each channel being sized to receive an elongate conductor therein, and each channel having an opening extending along an entire length thereof, each opening facing toward the central lumen; and

a longitudinally extending conductive layer overlaying the core; and

wherein a single channel of the plurality of channels of the core has another, second opening extending along the entire length thereof, the other opening facing toward an inner surface of the conductive layer.

32. The component of claim 31, wherein each channel of the core has a circular profile, except for the single channel that has the other, second opening facing toward the inner surface of the conductive layer, the circular profile having a diameter that is greater than a width of the opening of each channel.

33. The component of claim 31, wherein the other, second opening of the single channel has a width that is greater than the opening of the single channel that faces toward the central lumen.

34. A method for manufacturing an electrode assembly for a medical electrical lead, the electrode assembly comprising a plurality of electrodes spaced apart from one another along a length of the assembly, a first electrode of the plurality of electrodes defining a distal end of the length, and a second electrode of the plurality of electrodes defining a proximal end of the length, and the method comprising:

wedging a conductive distal end of a first conductor in a first channel within the first electrode so that the conductive distal end of the first conductor makes intimate contact with an inner surface of the first electrode, the first channel being formed by an insulative material inserted within the first electrode;

placing the first conductor in a second channel within the second electrode;

wedging a conductive distal end of a second conductor in a third channel within the second electrode so that the conductive distal end of the second conductor makes intimate contact with an inner surface of the second electrode, the third channel being formed by the insulative material inserted within the second electrode and being spaced apart from the second channel around a circumference of the central lumen;

electrically coupling the conductive wedged distal ends of the first and second conductors to the inner surface of the first and second electrodes, respectively; and

injecting another insulative material between adjacent electrodes of the plurality of electrodes.

35. The method of claim 34, further comprising:

forming an elongate core from the insulative material, the core having a length greater than or equal to the length of the electrode assembly, the core including the first, second, and third channels, the first and second channels being contiguous and defining a helical path, which extends between the first and second electrodes, and along which the first conductor extends when placed in the second channel; and

inserting the core within each electrode of the plurality of electrodes.

36. The method of claim 34 further comprising:

forming a plurality of cores from the insulative material, a first core of the plurality of cores including the first channel, and a second core of the plurality of cores including the second and third channels;

inserting each core of the plurality of cores into a corresponding electrode of the plurality of electrodes; and

after inserting each core, clocking the first and second electrodes prior to placing the first conductor in the second channel within the second electrode.