Implantable medical electrical stimulation lead fixation method and apparatus

• US 20070100411A1
• Filed: 10/27/2005
• Published: 05/03/2007
• Est. Priority Date: 10/27/2005
• Status: Abandoned Application

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Bonde, Eric
• Application Number:
  US11/260,350
• Publication Number:
  US 20070100411A1
• Time in Patent Office: Days
• US Class Current: 607/126
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

An implantable medical electrical lead for electrical stimulation of body tissue that includes a lead body extending between lead proximal and distal ends, at least one tine element that includes at least one flexible, pliant, tine, that is adapted to be folded inward and temporarily secured against the lead body using a temporary fixative, and at least one electrode, wherein the at least one electrode is distal of the at least one tine element on the lead body. A medical electrical stimulation system that includes 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 including a lead body extending between lead proximal and distal ends. at least one tine element that includes at least one flexible, pliant, tine, that is adapted to be folded inward and temporarily secured against the lead body using a temporary fixative, and at least one electrode, wherein the at least one electrode is distal of the at least one tine element on the lead body.

Claims

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

a lead body extending between lead proximal and distal ends;

at least one tine element comprising at least one flexible, pliant, tine, that is adapted to be folded inward and temporarily secured against the lead body using a temporary fixative; and

at least one electrode, wherein said at least one electrode is distal of the at least one tine element on the lead body.

2. The implantable medical lead according to claim 1, wherein the tines of the tine elements are formed of a flexible bio-compatible plastic or a flexible bio-compatible superelastic alloy.

3. The implantable medical lead according to claim 1, wherein the tines of the tine elements are formed of polyurethane compound, or silicone rubber compound.

4. The implantable medical lead according to claim 1, wherein the temporary fixative comprises sugar, sugar alcohol, sugar cellulose, protein, acrylic resin, alkyd resin, or a material made from animal intestines.

5. The implantable medical lead according to claim 4, wherein the temporary fixative comprises glucose, mannitol, polysaccharide glucose, albumin, polyglycolic acid, polyglactin, polydioxone, or polyglyconate.

6. The implantable medical lead according to claim 1, wherein the temporary fixative covers only a portion of the distal end of the lead body.

7. The implantable medical lead according to claim 1, wherein the temporary fixative creates a band that is positioned over the tines of at least one of the tine elements.

8. The implantable medical lead according to claim 7, wherein the temporary fixative comprises animal intestines, polyglycolic acid, polyglactin, polydioxone, or polyglyconate.

9. The implantable medical lead according to claim 7, wherein each tine element has an individual band positioned over the tine element.

10. The implantable medical lead according to claim 7, wherein there is one band positioned over the one or more tine elements.

11. The implantable medical lead according to claim 1, wherein the tines of at least one of the tine elements are angled forward.

12. The implantable medical lead according to claim 1, wherein there are at least four tine elements.

13. The implantable medical lead according to claim 1, wherein there is at least one tine element with forward facing tines and at least one tine element with backward facing tines.

14. 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

a lead body extending between lead proximal and distal ends;

at least one tine element comprising at least one flexible, pliant, tine, that is adapted to be folded inward and temporarily secured against the lead body using a temporary fixative; and

at least one electrode, wherein said at least one electrode is distal of the at least one tine element on the lead body.

15. The system according to claim 14, wherein the tines of the tine elements are formed of a flexible bio-compatible plastic or a flexible bio-compatible superelastic alloy.

16. The system according to claim 14, wherein the tines of the tine elements are formed of polyurethane compound, or silicone rubber compound.

17. The system according to claim 14, wherein the temporary fixative comprises sugar, sugar alcohol, sugar cellulose, protein, acrylic resin, alkyd resin, or a material made from animal intestines.

18. The system according to claim 17, wherein the temporary fixative comprises glucose, mannitol, polysaccharide glucose, albumin, polyglycolic acid, polyglactin, polydioxone, or polyglyconate.

19. The system according to claim 14, wherein the temporary fixative covers only a portion of the distal end of the lead body.

20. The system according to claim 14, wherein the temporary fixative creates a band that is positioned over the tines of at least one of the tine elements.

21. The system according to claim 20, wherein the temporary fixative comprises animal intestines, polyglycolic acid, polyglactin, polydioxone, or polyglyconate.

22. The system according to claim 20, wherein each tine element has an individual band positioned over the tine element.

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 tine element comprising at least one flexible, pliant, tine, that is adapted to be folded inward and temporarily secured against the lead body using a temporary fixative;

at least one electrode, wherein said at least one electrode is distal of the at least one tine element on the lead body;

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;

allowing the temporary fixative to dissolve, thereby allowing the at least one tine element to fold outward; 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.