IMPLANTABLE MEDICAL ELECTRICAL STIMULATION LEAD FIXATION METHOD AND APPARATUS

• US 20070261115A1
• Filed: 04/27/2006
• Published: 11/08/2007
• Est. Priority Date: 04/27/2006
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gerber, Martin, Bonde, Eric
• Granted Patent: US 8,200,343 B2
• Time in Patent Office: Days
• US Class Current: 726/22
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

The invention includes a implantable medical electrical lead for electrical stimulation of body tissue that includes at least one electrode; a lead body; and at least one modifiable portion, wherein the at least one modifiable portion has a first configuration and a second configuration, wherein the first configuration exists when axial tension is exerted on the at least one modifiable portion, and wherein the second configuration exhibits a greater resistance to movement of the lead within the body tissue than does the first configuration. Kits, and systems and methods of using the lead are also included.

Claims

1. An implantable medical electrical lead for electrical stimulation of body tissue comprising:

at least one electrode;

a lead body; and

at least one modifiable portion

wherein the at least one modifiable portion has a first configuration and a second configuration, wherein the first configuration exists when axial tension is exerted on the at least one modifiable portion, and

wherein the second configuration exhibits a greater resistance to movement of the lead within the body tissue than does the first configuration.

2. The lead according to claim 1, wherein the modifiable portion is coaxial with the lead body.

3. The lead according to claim 1, wherein the modifiable portion is made of silicone, or polyurethane.

4. The lead according to claim 1, wherein the modifiable portion is joined to the lead body using a medical grade adhesive.

5. The lead according to claim 1, wherein the diameter of the first configuration of the modifiable portion and the lead body diameter are substantially equal.

6. The lead according to claim 1, wherein the diameter of the first configuration of the modifiable portion is less than the lead body diameter.

7. The lead according to claim 1, wherein the diameter of the second configuration of the modifiable portion is at least about 50% larger than the lead body diameter.

8. The lead according to claim 1, wherein the diameter of the second configuration of the modifiable portion is at least about 100% larger than the lead body diameter.

9. The lead according to claim 1, wherein the at least one modifiable portion has an overall length of about 4 mm to about 25 mm.

10. The lead according to claim 1, wherein the at least one modifiable portion has an overall length of about 5 mm to about 15 mm.

11. The lead according to claim 1, wherein the at least one modifiable portion has an overall length of about 8 mm to about 12 mm.

12. The lead according to claim 1, wherein the at least one modifiable portion has a width when the axial tension is released of about 2 mm to about 8 mm.

13. The lead according to claim 1, wherein the at least one modifiable portion has a width when the axial tension is released of about 3 mm to about 6 mm.

14. The lead according to claim 1, wherein the at least one modifiable portion has a width when the axial tension is released of about 3 mm to about 4 mm.

15. The lead according to claim 1, wherein the lead has at least four electrodes.

16. The lead according to claim 1, wherein there are two or more modifiable portions.

17. A kit comprising:

an implantable medical electrical lead for electrical stimulation of body tissue comprising;

at least one electrode;

a lead body;

at least one modifiable portion

wherein the at least one modifiable portion has a first configuration and a second configuration, wherein the first configuration exists when axial tension is exerted on the at least one modifiable portion, and

wherein the second configuration exhibits a greater resistance to movement of the lead within the body tissue than does the first configuration; and

an apparatus for applying axial tension on the at least one modifiable portion.

18. The kit according to claim 17, wherein the apparatus for applying axial tension on the at least one modifiable portion is a sheath.

19. The kit according to claim 18, wherein the sheath is made of metal or plastic.

20. A medical electrical stimulation system comprising:

an implantable pulse generator for providing medical electrical stimulation; and

an implantable medical electrical lead for electrical stimulation of body tissue comprising;

at least one electrode;

a lead body;

at least one modifiable portion

wherein the at least one modifiable portion has a first configuration and a second configuration, wherein the first configuration exists when axial tension is exerted on the at least one modifiable portion, and

wherein the second configuration exhibits a greater resistance to movement of the lead within the body tissue than does the first configuration.

21. A method of providing electrical stimulation of body tissue at a stimulation site employing an implantable pulse generator comprising:

providing an implantable medical lead comprising;

at least one electrode;

a lead body;

at least one modifiable portion

wherein the at least one modifiable portion has a first configuration and a second configuration, wherein the first configuration exists when axial tension is exerted on the at least one modifiable portion, and

wherein the second configuration exhibits a greater resistance to movement of the lead within the body tissue than does the first configuration; and

at least one proximal connector element formed in a connector array in a proximal segment of the lead body;

applying axial tension to at least the at least one modifiable portion;

percutaneously introducing the implantable medical lead adjacent to the stimulation site;

removing the axial tension to at least the at least one modifiable portion; and

coupling the at least one proximal connector element with the implantable pulse generator.

22. The method according to claim 21, wherein the axial tension is applied via an external sheath that covers at least the at least one modifiable portion.

23. The method according to claim 21, wherein the axial tension is applied via an internal stylet that extends through at least the at least one modifiable portion.

24. The method according to claim 21 further comprising the step of using an insulated needle with both ends exposed to apply electrical stimulation through the needle using an external pulse generator in order to determine the best location for the at least one electrode.

25. The method according to claim 24 further comprising the step of testing the efficacy of the location.

26. The method according to claim 25, wherein the step of testing the efficacy of the location is accomplished by evaluating the physiologic response in relation to the electrical threshold energy required to elicit the response.

27. The method according to claim 21 further comprising

reapplying the axial tension to at least the at least one modifiable portion;

moving the lead; and

removing the axial tension to at least the at least one modifiable portion.