LEAD BODY CONSTRUCTIONS FOR IMPLANTABLE MEDICAL ELECTRICAL LEADS

• US 20090054949A1
• Filed: 08/22/2007
• Published: 02/26/2009
• Est. Priority Date: 08/22/2007
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Alexander, James A., Chapeau, Loren S.
• Granted Patent: US 7,974,704 B2
• Time in Patent Office: Days
• US Class Current: 607/37
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: H01B 7/1895 Internal space filling-up means
• 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

A lead body of an implantable medical electrical lead includes a first filler and a second filler, each extending within a proximal portion thereof. The first filler may have a stiffness that is less than that of the second filler, and may surround and isolate a plurality of conductors which are coupled to a connector terminal of the lead, which connector terminal extends proximally from a proximal end of the lead body. The second filler extends along a limited length, alongside the first filler, wherein the limited length extends distally from the connector terminal; the second filler may further extend into the connector terminal.

Claims

1. An implantable medical electrical lead comprising:

an elongate insulative lead body including a proximal end and a distal end;

a plurality of conductors extending longitudinally within the lead body, from the proximal end to the distal end of the lead body;

a connector terminal extending proximally from the proximal end of the lead body and coupled to the plurality of conductors;

a first filler extending longitudinally within the lead body, around the plurality of conductors and along a length of the lead body, the first filler having a stiffness;

a second filler extending longitudinally alongside the first filler within the lead body, the second filler having a stiffness greater than the stiffness of the first filler, and the second filler extending along a limited length, which limited length extends distally from the connector terminal, at the proximal end of the lead body.

2. The lead of claim 1, wherein the lead body further includes a first lumen in which the first filler extends and a second lumen in which the second filler extends;

and the first and second lumens each include a central longitudinal axis that is radially offset from a central longitudinal axis of the lead body.

3. The lead of claim 1, wherein the lead body further includes a first lumen in which the first filler extends and a tube extending longitudinally within the first lumen to form a second lumen in which the second filler extends.

4. The lead of claim 3, wherein a central longitudinal axis of the second lumen is radially offset from a central longitudinal axis of the first lumen.

5. The lead of claim 1, wherein the limited length, along which the second filler extends, is no greater than approximately two inches.

6. The lead of claim 1, wherein the first filler comprises silicone adhesive.

7. The lead of claim 6, wherein he second filler comprises epoxy adhesive.

8. The lead of claim 1, wherein the second filler comprises epoxy adhesive.

9. The lead of claim 8, wherein the second filler further comprises a pre-formed component.

10. The lead of claim 1, wherein the second filler comprises a pre-formed component.

11. The lead of claim 10, wherein the pre-formed component comprises a coil member, a polymer jacket surrounding the coil member, and epoxy adhesive extending within the coil member.

12. The lead of claim 10, wherein the pre-formed component comprises epoxy adhesive and a pre-formed reinforcing member extending within the epoxy adhesive.

13. The lead of claim 1, wherein:

the connector terminal includes a plurality of connector elements isolated from one another;

each conductor of the plurality of conductors is coupled to a corresponding connector element of the plurality of connector elements; and

the first filler isolates the plurality of conductors from one another within the lead body.

14. The lead of claim 1, wherein the second filler further extends into the connector terminal.

15. The lead of claim 14, wherein the second filler comprises epoxy adhesive.

16. The lead of claim 15, wherein the second filler further comprises a pre-formed component.

17. The lead of claim 14, wherein the second filler comprises a pre-formed component.

18. The lead of claim 17, wherein the pre-formed component comprises a coil member, a polymer jacket surrounding the coil member, and epoxy adhesive extending within the coil member.

19. The lead of claim 17, wherein the preformed component comprises epoxy adhesive and a pre-formed reinforcing member extending within the epoxy adhesive.

20. The lead of claim 1, further comprising a connector port extending distally from the distal end of the lead body and coupled to the connector terminal via the plurality of conductors.

21. The lead of claim 1, further comprising an electrode array extending distally from the distal end of the lead body and coupled to the connector terminal via the plurality of conductors.

22. A method for assembling a proximal portion of a medical electrical lead, the method comprising:

forming a relatively rigid filler by dispensing an adhesive material into a tube;

inserting the relatively rigid filler into a limited length of an elongate insulative body of the lead, at a proximal end thereof;

dispensing a relatively flexible filler into the body, at the proximal end thereof and alongside the limited length for the relatively rigid filler; and

attaching a connector terminal subassembly to the proximal end of the body.

23. The method of claim 22, further comprising attaching a polymer jacket about a coil member to form the tube into which the adhesive material is dispensed.

24. The method of claim 22, wherein forming the relatively rigid filler further comprises inserting a pre-formed reinforcing member into the tube after dispensing the adhesive material therein.

25. The method of claim 22, further comprising inserting the relatively rigid filler into a lumen of the connector terminal subassembly.

26. The method of claim 22, further comprising dispensing the relatively flexible filler into the lumen of a connector terminal subassembly.

27. An implantable medical electrical lead system comprising:

an implantable medical electrical stimulation lead comprising;

an elongate insulative stimulation lead body including a proximal end and a distal end;

a stimulation lead connector extending proximally from the proximal end of the stimulation lead body;

a stimulation lead electrode array extending distally from the distal end of the stimulation lead body; and

a plurality of stimulation lead conductors extending within the stimulation lead body, from the proximal end to the distal end thereof, the plurality of stimulation lead conductors coupling the stimulation lead connector to the stimulation lead electrode array; and

an implantable medical electrical adapter lead comprising;

an elongate insulative adapter lead body including a proximal end and a distal end;

a connector terminal extending proximally from the proximal end of the adapter lead body;

a connector port extending distally from the distal end of the adapter lead body;

a plurality of adapter lead conductors extending longitudinally within the adapter lead body, from the proximal end to the distal end of the adapter lead body, the plurality of adapter lead conductors coupling the connector terminal to the connector port;

a first filler extending longitudinally within the adapter lead body, around the adapter lead conductors and along a length of the adapter lead body, the first filler having a stiffness;

a second filler extending within the longitudinally alongside the first filler within the lead body, the second filler having a stiffness greater than the stiffness of the first filler, and the second filler extending along a limited length, which limited length extends distally from the connector terminal at the proximal end of the adapter lead body;

wherein the connector port of the adapter lead is adapted to couple with the stimulation lead connector for electrical coupling of the stimulation lead electrode array with the connector terminal of the adapter lead.

28. The lead system of claim 27, wherein the adapter lead body further includes a first lumen in which the first filler extends and a second lumen in which the second filler extends;

and the first and second lumens each include a central longitudinal axis that is radially offset from a central longitudinal axis of the adapter lead body.

29. The lead system of claim 27, wherein the adapter lead body further includes a first lumen in which the first filler extends and a tube extending longitudinally within the first lumen to form a second lumen in which the second filler extends.

30. The lead system of claim 29, wherein a central longitudinal axis of the second lumen is radially offset from a central longitudinal axis of the first lumen.

31. The lead system of claim 27, wherein the limited length, along which the second filler extends, is no greater than two inches.

32. The lead system of claim 27, wherein the first filler comprises silicone adhesive.

33. The lead system of claim 32, wherein he second filler comprises epoxy adhesive.

34. The lead system of claim 27, wherein the second filler comprises epoxy adhesive.

35. The lead system of claim 34, wherein the second filler further comprises a pre-formed component.

36. The lead system of claim 27, wherein the second filler comprises a pre-formed component.

37. The lead system of claim 36, wherein the pre-formed component comprises a coil member, a polymer jacket surrounding the coil member, and epoxy adhesive extending within the coil member.

38. The lead system of claim 36, wherein the preformed component comprises epoxy adhesive and a pre-formed reinforcing member extending within the epoxy adhesive.

39. The lead system of claim 27, wherein:

the stimulation lead connector includes a plurality of first connector elements isolated from one another;

the stimulation lead electrode array includes a plurality of electrodes isolated from one another;

the plurality of stimulation lead conductors are isolated from one another within the stimulation lead body;

each stimulation lead conductor of the plurality of stimulation lead conductors couples a corresponding first connector element of the plurality of first connector elements to a corresponding electrode of the plurality of electrodes;

the connector terminal of the adapter lead includes a plurality of second connector elements isolated from one another;

the connector port of the adapter lead includes a plurality of electrical contacts isolated from one another and positioned to make contact with a corresponding first connector element of the plurality of connector elements of the stimulation lead connector, when the connector port is coupled with the stimulation lead connector;

each adapter lead conductor of the plurality of adapter lead conductors couples a corresponding second connector element of the connector terminal to a corresponding electrical contact of the connector port; and

the first filler isolates the plurality of adapter lead conductors from one another within the adapter lead body.

40. The lead system of claim 27, wherein the second filler further extends into the connector terminal of the adapter lead.

41. The lead system of claim 40, wherein the second filler comprises epoxy adhesive.

42. The lead system of claim 41, wherein the second filler further comprises a pre-formed component.

43. The lead system of claim 40, wherein the second filler comprises a pre-formed component.

44. The lead system of claim 43, wherein the pre-formed component comprises a coil member, a polymer jacket surrounding the coil member, and epoxy adhesive extending within the coil member.

45. The lead system of claim 43, wherein the preformed component comprises epoxy adhesive and a pre-formed reinforcing member extending within the epoxy adhesive.

46. An implantable medical electrical lead comprising:

an elongate insulative lead body including a proximal end and a distal end;

a plurality of conductors extending longitudinally within the lead body, from the proximal end to the distal end of the lead body;

a connector terminal extending proximally from the proximal end of the lead body and coupled to the plurality of conductors;

a first filler extending longitudinally within the connector terminal and the lead body, around the plurality of conductors and along a length of the lead body, the first filler having a stiffness;

a second filler extending longitudinally alongside the first filler within the connector terminal and the lead body, the second filler comprising a pre-formed component and epoxy adhesive extending therein, the second filler having a stiffness greater than the stiffness of the first filler, and the second filler extending along a limited length of the lead body.