Implantable medical lead including a plurality of tine elements

• US 8,626,314 B2
• Filed: 07/14/2011
• Issued: 01/07/2014
• Est. Priority Date: 08/31/2001
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Swoyer, John M., Carlton, Keith R., Gerber, Martin T., Mamo, George J., Spinelli, Michele, Hartle, Steven D.
• Primary Examiner(s): STOKLOSA, JOSEPH A
• Application Number:
  US13/183,289
• Publication Number:
  US 20110270269A1
• Time in Patent Office: 908 Days
• Field of Search: 607116-118, 607/128
• US Class Current: 607/117
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

An implantable medical electrical lead comprises a lead body extending between a distal end and a proximal end, and the distal end having at least one electrode of an electrode array extending longitudinally from the distal end toward the proximal end. The lead body at its proximal end may be coupled to a pulse generator, additional intermediate wiring, or other stimulation device. A fixation mechanism is formed on or integrally with the lead body proximal to the electrode array that is adapted to be implanted in and engage subcutaneous tissue, particularly muscle tissue, to inhibit axial movement of the lead body and dislodgement of the stimulation electrodes. The fixation mechanism comprises a plurality of tine elements arrayed in a tine element array along a segment of the lead.

Claims

1. A system comprising:

an implantable medical lead comprising;

a lead body extending between a proximal end and a distal end;

a plurality of conductors within the lead body;

a plurality of electrodes, wherein each electrode is electrically connected to a conductor of the plurality of conductors; and

a plurality of tine elements extending from the lead body, wherein all tine elements of the plurality of tine elements are positioned between a most proximal electrode of the plurality of electrodes and the proximal end of the lead body, each tine element comprising a plurality of flexible, pliant tines, each tine having a tine width and thickness and extending a tine length from an attached tine end to a free tine end, the attached tine end attached to the lead body from a tine attachment site and supporting the tine extending outwardly of the lead body and proximally toward the lead proximal end, wherein the plurality of tines of the plurality of tine elements are adapted to be folded inward against the lead body when fitted into and constrained by a lumen of an introducer without overlapping one another and deploy outward to engage body tissue when the introducer is withdrawn to release the plurality of tines, wherein the plurality of tine elements is separate from and axially displaced from the plurality of electrodes.

2. The system of claim 1, wherein the tines of the tine elements are formed of a flexible, bio-compatible plastic selected from the group consisting of medical grade polyurethane compounds and silicone rubber compounds.

3. The system of claim 1, wherein the tines of the tine elements are formed of a flexible, implantable grade superelastic alloy.

4. The system of claim 1, wherein the tine attachment sites of the plurality of tine elements are separated longitudinally along the lead body by a distance that is greater than or equal to the tine length so that the tines are not overlapping one another when the tines are folded against the lead body towards the proximal end of the lead body.

5. The system of claim 1, wherein tine lengths and tine widths of tines of a first tine element of the plurality of tine elements are configured to enable the tines of the first tine element to fold toward the proximal end of the lead body alongside and interleaved with tines of a second tine element of the plurality of tine elements, the second tine element being located closer to the proximal end of the lead body than the first tine element.

6. The system of claim 1, wherein a number of tine elements in the plurality of tine elements is equal to a number of tines in the plurality of tines of each tine element.

7. The system of claim 1, wherein each tine element in the plurality of tine elements comprises an equal number of tines.

8. The system of claim 1, wherein at least one of the electrodes of the plurality of electrodes comprises an elongated, flexible electrode configured to assume a curve when implanted in relation to body tissue.

9. The system of claim 1, wherein the tine attachment sites of each tine element of the plurality of tine elements are disposed in a common circumference of the lead body, and the tine attachment sites of adjoining tine elements along the lead body are radially offset from one another around the common circumference such that the tine free ends of the tines of each adjacent tine element are configured to engage against body tissue at radially and axially separated points along the lead body.

10. The system of claim 1, further comprising the introducer.

22. The system of claim 1, further comprising a tine mounting band, wherein at least one tine element is mounted to the lead via the tine mounting band.

11. A system comprising:

an implantable pulse generator configured to generate electrical stimulation; and

an implantable medical lead configured to be electrically coupled to the implantable pulse generator and introduced through and released into body tissue via an introducer defining an introducer lumen, the implantable medical lead comprising;

a lead body extending between a proximal end and a distal end;

a plurality of conductors within the lead body;

a plurality of electrodes, wherein each electrode is electrically connected to a conductor of the plurality of conductors; and

a plurality of tine elements extending from the lead body, wherein all tine elements of the plurality of tine elements are positioned between a most proximal electrode of the plurality of electrodes and the proximal end of the lead body, each tine element comprising a plurality of flexible, pliant tines, each tine having a tine width and thickness and extending a tine length from an attached tine end to a free tine end, the attached tine end attached to the lead body from a tine attachment site and supporting the tine extending outwardly of the lead body and proximally toward the lead proximal end, wherein the plurality of tines of the plurality of tine elements are adapted to be folded inward against the lead body when fitted into and constrained by the lumen of the introducer without overlapping one another and deploy outward to engage body tissue when the introducer is withdrawn proximally, wherein the plurality of tine elements is separate from and axially displaced from the plurality of electrodes.

12. The system of claim 11, wherein the tines of the tine elements are formed of a flexible, bio-compatible plastic selected from the group consisting of medical grade polyurethane compounds and silicone rubber compounds.

13. The system of claim 11, wherein the tines of the tine elements are formed of a flexible, implantable grade superelastic alloy.

14. The system of claim 11, wherein the tine attachment sites of the plurality of tine elements are separated longitudinally along the lead body by a distance that is greater than or equal to the tine length so that the tines are not overlapping one another when the tines are folded against the lead body towards the proximal end of the lead body.

15. The system of claim 11, wherein tine lengths and tine widths of tines of a first tine element of the plurality of tine elements are configured to enable the tines of the first tine element to fold toward the proximal end of the lead body alongside and interleaved with tines of a second tine element of the plurality of tine elements, the second tine element being located closer to the proximal end of the lead body than the first tine element.

16. The system of claim 11, wherein at least one of the electrodes of the plurality of electrodes comprises an elongated, flexible electrode configured to assume a curve when implanted in relation to body tissue.

17. The system of claim 11, wherein the tine attachment sites of each tine element of the plurality of tine elements are disposed in a common circumference of the lead body, and the tine attachment sites of adjoining tine elements along the lead body are radially offset from one another around the common circumference such that the tine free ends of the tines of each adjacent tine element are configured to engage against body tissue at radially and axially separated points along the lead body.

23. The system of claim 11, further comprising a tine mounting band, wherein at least one tine element is mounted to the lead via the tine mounting band.

18. A method comprising:

introducing an introducer into body tissue, the introducer defining a lumen extending between a lumen proximal end and a lumen distal end;

advancing a medical lead through the lumen of the introducer, the medical lead comprising;

a lead body extending between a proximal end and a distal end;

a plurality of conductors within the lead body;

a plurality of electrodes, wherein each electrode is electrically connected to a conductor of the plurality of conductors; and

a plurality of tine elements extending from the lead body, wherein all tine elements of the plurality of tine elements are positioned between a most proximal electrode of the plurality of electrodes and the proximal end of the lead body, each tine element comprising a plurality of flexible, pliant tines, each tine having a tine width and thickness and extending through a tine length from an attached tine end to a free tine end, the attached tine end attached to the lead body from a tine attachment site and supporting the tine extending outwardly of the lead body and proximally toward the lead proximal end, wherein the plurality of tines of the plurality of tine elements are adapted to be folded inward against the lead body when fitted into and constrained by the lumen of the introducer without overlapping one another and deploy outward to engage body tissue when the introducer is withdrawn proximally, wherein the plurality of tine elements is separate from and axially displaced from the plurality of electrodes; and

withdrawing the introducer from the body tissue to deploy the plurality of tine elements.

19. The method of claim 18, wherein introducing the introducer into body tissue comprises percutaneously introducing the introducer through body tissue.

20. The method of claim 18, wherein withdrawing the introducer from the body tissue to deploy the plurality of tine elements comprises withdrawing the introducer from the body tissue to deploy the plurality of tine elements into subcutaneous tissue, wherein the plurality of tine elements engage with the subcutaneous tissue to inhibit axial movement of the lead body and dislodgement of the plurality of electrodes.

21. The method of claim 18, wherein withdrawing the introducer from the body tissue to deploy the plurality of tine elements comprises anchoring, with the plurality of tine elements, the plurality of electrodes in operative relation to a selected stimulation site.

24. The method of claim 18, wherein the medical lead further comprises a tine mounting band, wherein at least one tine element is mounted to the lead via the tine mounting band.