Implantable Medical Electrical Stimulation Lead Fixation Method and Apparatus

• US 20070255367A1
• Filed: 04/27/2006
• Published: 11/01/2007
• Est. Priority Date: 04/27/2006
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Gerber, Martin, Bonde, Eric
• Application Number:
  US11/380,505
• Publication Number:
  US 20070255367A1
• Time in Patent Office: Days
• US Class Current: 607/116
• 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: A61N 1/36071 Pain

Abstract

An implantable medical electrical lead for electrical stimulation of body tissue that includes at least one modifiable portion that exhibits a permanent configuration and a temporary configuration, wherein the temporary configuration exists only when the surrounding magnetic field is increased, wherein the permanent configuration of the modifiable portion exhibits a greater resistance to movement of the lead within the body tissue than does the temporary configuration; and at least one electrode configured to provide electrical stimulation of body tissue, wherein the lead has a proximal end and a distal end. Systems, and methods of implanting the leads are also included in the invention.

Claims

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

at least one modifiable portion that exhibits a permanent configuration and a temporary configuration, wherein the temporary configuration exists only when the surrounding magnetic field is increased, wherein the permanent configuration of the modifiable portion exhibits a greater resistance to movement of the lead within the body tissue than does the temporary configuration; and

at least one electrode configured to provide electrical stimulation of body tissue,

wherein the lead has a proximal end and a distal end.

2. The lead according to claim 1, wherein the at least one modifiable portion is a magnetic shape memory material.

3. The lead according to claim 2, wherein the magnetic shape memory material is a nickel-manganese-gallium alloy.

4. The lead according to claim 3, wherein the nickel-manganese-gallium alloy is Ni₂MnGa.

5. The lead according to claim 1, wherein the temporary configuration exists when the surrounding magnetic field is increased to about 0.6 T or higher.

6. The lead according to claim 1, wherein the permanent configuration is a helical configuration.

7. The lead according to claim 1, wherein the permanent configuration is a stepped configuration.

8. The lead according to claim 1, wherein the permanent configuration is a zigzag configuration.

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

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

11. The lead according to claim 1, wherein there is two or more modifiable portions.

12. A medical electrical stimulation system comprising:

an implantable pulse generator for providing medical electrical stimulation; and

a medical electrical lead coupled to the implantable pulse generator for electrical stimulation of body tissue, the medical electrical lead comprising;

at least one modifiable portion that exhibits a permanent configuration and a temporary configuration, wherein the temporary configuration exists only when the surrounding magnetic field is increased, wherein the permanent configuration of the modifiable portion exhibits a greater resistance to movement of the lead within the body tissue than does the temporary configuration; and

at least one electrode configured to provide electrical stimulation of body tissue, wherein the lead has a proximal end and a distal end.

13. The system according to claim 12, wherein the at least one modifiable portion is a magnetic shape memory material.

14. The system according to claim 13, wherein the magnetic shape memory material is a nickel-manganese-gallium alloy.

15. The system according to claim 14, wherein the nickel-manganese-gallium alloy is Ni₂MnGa.

16. The system according to claim 12, wherein the temporary configuration exists when the surrounding magnetic field is increased to about 0.6 T or higher.

17. The system according to claim 12, wherein the permanent configuration is a helical configuration.

18. The system according to claim 12, wherein the permanent configuration is a stepped configuration.

19. The system according to claim 12, wherein the permanent configuration is a zigzag configuration.

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

21. The system according to claim 12, wherein the lead has at least four electrodes.

22. The system according to claim 12, wherein there is two or more modifiable portions.

23. 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;

a lead body extending between lead proximal and distal ends;

at least one modifiable portion that exhibits a permanent configuration and a temporary configuration, wherein the temporary configuration exists only when the surrounding magnetic field is increased, wherein the permanent configuration of the modifiable portion exhibits a greater resistance to movement of the lead within the body tissue than does the temporary configuration; and

at least one electrode configured to provide electrical stimulation of body tissue;

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

increasing the surrounding magnetic field so that the modifiable portion transitions from the permanent configuration to the temporary configuration

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

removing the increased surrounding magnetic field so that the modifiable portion transitions from the temporary configuration to the permanent configuration; and

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

24. The method according to claim 23 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 23 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 23, wherein the surrounding magnetic field is increased by bringing the patient to a magnetic field generator.

28. The method according to claim 23, wherein the surrounding magnetic field is increased by bringing a magnetic field generator to the patient.

29. The method according to claim 23 further comprising

increasing the surrounding magnetic field again;

repositioning the lead; and

removing the increased surrounding magnetic field.