Implantable medical lead including tine markers

• US 20070050004A1
• Filed: 10/30/2006
• Published: 03/01/2007
• Est. Priority Date: 08/31/2001
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Spinelli, Michele, Carlton, Keith, Swoyer, John, Mamo, George, Gerber, Martin, Hartle, Steven
• Granted Patent: US 8,000,805 B2
• Time in Patent Office: Days
• US Class Current: 607/116
• 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 particularly for stimulation of the sacral nerves 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 M tine elements arrayed in a tine element array along a segment of the lead proximal to the stimulation electrode array. Each tine element comprises at least N 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 is attached to the lead body from a tine attachment site and supports the tine extending outwardly of the lead body and proximally toward the lead proximal end. The M×N tines are adapted to be folded inward against the lead body when fitted into and constrained by the lumen of an introducer such that the tine free ends of more distal tines of more distal tine elements are urged toward or alongside the attached tine ends of the adjacent more proximal tines of more proximal tine elements, and the folded tines do not overlap one another.

Claims

1. An implantable medical lead comprising:

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

an electrode disposed proximate to the distal end of the lead body;

a tine element extending from the lead body; and

a marker positioned on the lead body proximate the tine element.

2. The implantable medical lead of claim 1, wherein the marker is positioned to indicate a location of the tine element with respect to an introducer.

3. The implantable medical lead of claim 1, wherein the marker comprises a first marker proximal to the tine element and a second marker distal to the tine element.

4. The implantable medical lead of claim 1, wherein the marker comprises a radiographic imaging marker.

5. The implantable medical lead of claim 1, wherein the marker comprises a band extending around an outer perimeter of the lead body.

6. The implantable medical lead of claim 1, wherein the tine element is positioned between the electrode and the proximal end of the lead body.

7. The implantable medical lead of claim 1, wherein the tine element is formed of a flexible implantable grade superelastic alloy.

8. The implantable medical lead of claim 1, wherein the electrode comprises an elongated, flexible electrode adapted to assume a curve when implanted in relation to body tissue.

9. The implantable medical lead of claim 1, wherein the electrode comprises a plurality of stimulation electrodes arranged in an electrode array extending proximally from the distal end of the lead through a distal segment of the lead body, and the implantable medical lead further comprises:

a plurality of proximal connector elements formed in a connector array in a proximal segment of the lead body;

a plurality of lead conductors extending between the plurality of connector elements and the plurality of stimulation electrodes; and

a plurality of tine elements formed in a tine element array extending through the proximal segment of the lead proximal to the electrode array, each tine element comprising a plurality of flexible 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 proximal end of the lead body, whereby the plurality of tines are adapted to be folded inward against the lead body when fitted into and constrained by a lumen of an introducer and deploy outward to engage body tissue when the introducer is withdrawn proximally.

10. The implantable medical lead of claim 9, wherein the tine attachment sites of the plurality of tine elements are separated longitudinally along the lead body in the tine element array by a distance that is substantially equal to or exceeds the tine length when folded proximally against the lead body so that the tines are not overlapping one another.

11. The implantable medical lead of claim 9, wherein the tine attachment sites of each 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 engage against body tissue at radially and axially separated points along the tine element array.

12. The implantable medical lead of claim 9, wherein tine lengths and tine widths are selected to enable a more distal plurality of tines of more distal tine elements of the tine element array to be folded proximally alongside and interleaved with adjacent proximal tines of more proximal tine elements.

13. The implantable medical lead of claim 9, wherein each of the plurality of tine elements include an equal number of tines.

14. An assembly comprising:

an introducer comprising a lumen; and

a lead configured to be introduced into the lumen of the introducer and comprising;

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

an electrode disposed proximate to the distal end of the lead body;

a tine element extending from the lead body; and

a marker positioned on the lead body proximate the tine element.

15. The assembly of claim 14, wherein the marker is positioned to indicate a location of the tine element with respect to the introducer.

16. The assembly of claim 14, wherein the marker is visible when the tine element is deployed from the introducer.

17. The assembly of claim 14, wherein the marker is a first marker and the introducer comprises a second marker to indicate the location of the tine element with respect to the introducer.

18. The assembly of claim 14, wherein the marker comprises a first marker proximal to the tine element and a second marker distal to the tine element.

19. The assembly of claim 14, wherein the marker and at least a portion of the lumen of the introducer are fluoroscopically visible.

20. A method of implanting a medical lead proximate to a stimulation site in a patient, the method comprising:

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

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

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

an electrode disposed proximate to the distal end of the lead body;

a tine element extending from the lead body; and

a marker positioned on the lead body proximate to the tine element;

positioning the lumen distal end of the lumen proximate to the stimulation site to dispose the electrode in operative relation to body tissue to be stimulated; and

withdrawing the introducer proximally past the marker on the lead body to release the tine element.

21. The method of claim 20, wherein introducing the introducer into body tissue comprises percutaneously introducing the introducer through body tissue.

22. The method of claim 20, wherein the tine element comprises a plurality of tine elements each comprising a plurality of tines, and wherein withdrawing the introducer proximally past the marker on the lead body successively releases the plurality of tines of each of the plurality of tine elements to deploy the plurality of tines outward to engage body tissue and inhibit axial dislodgement of the electrode.

23. The method of claim 20, wherein the medical lead further comprises a connector element electrically coupled to the electrode, wherein the method further comprises electrically coupling the connector element to an implantable pulse generator.

24. The method of claim 20, and further comprising determining a location of the tine element within the lumen of the introducer by locating the marker.