Implantable Medical Electrical Stimulation Lead Fixation Method and Apparatus

• US 20070255365A1
• Filed: 04/27/2006
• Published: 11/01/2007
• 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 8,145,323 B2
• Time in Patent Office: Days
• US Class Current: 607/116
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36007 of urogenital or gastrointestinal organs, e.g. for incontinence control
• CPC Class Codes: A61N 1/36071 Pain

Abstract

An 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 can exist in both a deflated configuration and an inflated configuration, and wherein the inflated configuration exhibits a greater resistance to movement of the lead within the body tissue than does the deflated configuration. Kits, systems, and methods of using the leads 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 can exist in both a deflated configuration and an inflated configuration, and

wherein the inflated configuration exhibits a greater resistance to movement of the lead within the body tissue than does the deflated 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 diameter of the deflated configuration of the modifiable portion and the lead body diameter are substantially equal.

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

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

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

7. The lead according to claim 1, wherein the at least one modifiable portion is from about 3 mm to about 15 mm long.

8. The lead according to claim 1, wherein the at least one modifiable portion is from about 4 mm to about 10 mm long.

9. The lead according to claim 1, wherein the at least one modifiable portion is from about 5 mm to about 7 mm long.

10. The lead according to claim 1, wherein the lead body further comprises a fluid conduit that is configured to communicate fluid between the modifiable portion and an area outside the lead.

11. The lead according to claim 10, further comprising a port for access to the fluid conduit.

12. The lead according to claim 1, wherein the lead has two or more electrodes.

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

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

15. A kit comprising:

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

at least one electrode;

a lead body comprising at least a fluid conduit;

at least one modifiable portion

wherein the at least one modifiable portion can exist in both a deflated configuration and an inflated configuration,

wherein the inflated configuration exhibits a greater resistance to movement of the lead within the body tissue than does the deflated configuration, and

wherein the fluid conduit of the lead body functions as a conduit for fluid between the modifiable portion and an area outside the lead; and

an apparatus for introducing fluid into the fluid conduit.

16. The kit according to claim 15, wherein the apparatus for introducing fluid into the fluid conduit comprises a port.

17. The kit according to claim 16, wherein the port comprises a self-sealing septum.

18. The kit according to claim 17 further comprising a syringe for introduction of fluid via the self-sealing septum.

19. The kit according to claim 15, wherein the modifiable portion is made of silicone, polyamide, or polyurethane.

20. The kit according to claim 15, wherein the modifiable portion is made of polyurethane.

21. The kit according to claim 15 further comprising fluid for introduction into the fluid conduit.

22. The kit according to claim 21, wherein the fluid is saline, de-ionized water, or biocompatible oil.

23. 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 can exist in both a deflated configuration and an inflated configuration,

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

24. 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 comprising at least a fluid conduit;

at least one modifiable portion

wherein the at least one modifiable portion can exist in both a deflated configuration and an inflated configuration,

wherein the inflated configuration exhibits a greater resistance to movement of the lead within the body tissue than does the deflated configuration, and

wherein the fluid conduit of the lead body functions as a conduit for fluid between the modifiable portion and an area outside the lead; and

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

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

adding fluid to the fluid conduit to transition the at least one modifiable portion from the deflated configuration to the inflated configuration; and

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

25. The method according to claim 24 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.

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

27. The method according to claim 26, 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.

28. The method according to claim 24, wherein fluid is added to the fluid conduit via a port.

29. The method according to claim 28, wherein the fluid is injected via the port into the fluid conduit using a syringe.

30. The method according to claim 24 further comprising

removing the fluid from the fluid conduit, thereby transitioning the inflated configuration to the deflated configuration;

moving the lead; and

adding the fluid to the fluid conduit, thereby transitioning the deflated configuration to the inflated configuration.