Compliant stimulating electrodes and leads and methods of manufacture and use

• US 20060247749A1
• Filed: 05/02/2005
• Published: 11/02/2006
• Est. Priority Date: 05/02/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: Colvin, Michael S.
• Granted Patent: US 8,594,807 B2
• Time in Patent Office: Days
• US Class Current: 607/116
• CPC Class Codes: A61L 31/14 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 31/145 Hydrogels or hydrocolloids
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence

Abstract

A device for stimulating body tissue includes a lead body and at least one stimulating electrode disposed on the lead body. The lead body is configured and arranged to be substantially rigid outside the patient'"'"'s body and during insertion into the patient'"'"'s body and then becomes non-rigid upon exposure within the patient'"'"'s body;.

Claims

1. A device for stimulating tissue inside a patient'"'"'s body, comprising:

a lead body that is configured and arranged to be substantially rigid outside the patient'"'"'s body and during insertion into the patient'"'"'s body and then becomes non-rigid upon exposure within the patient'"'"'s body; and

at least one stimulating electrode disposed on the lead body.

2. The device of claim 1, wherein the lead body comprises a plastic material that has a glass transition temperature that is near or below body temperature.

3. The device of claim 1, wherein the lead body comprises a plastic material that has a glass transition temperature that is in the range of 25 to 38°

C.

4. The device of claim 1, wherein the lead body comprises a material that, upon extended exposure to water, becomes non-rigid.

5. The device of claim 4, wherein the material comprises a crosslinked hydrogel material.

6. The device of claim 1, wherein the lead body is configured and arranged to absorb lipids and soften.

7. The device of claim 1, wherein a portion of the lead body dissolves in water.

8. The device of claim 7, wherein the portion comprises a water-soluble material selected from sugars, steroids, anti-inflammatory agents, and antibiotics.

9. The device of claim 8, wherein lead body comprises a plastic material and the water-soluble material is impregnated in the plastic material.

10. The device of claim 8, wherein the lead body comprises at least one space within the plastic material of the lead body and a least a portion of the water-soluble material is disposed in the at least one space.

11. The device of claim 1, wherein the lead body has no stylet lumen.

12. A method of treating body tissue, the method comprising:

inserting a lead into the body tissue, the lead comprising at least one stimulation electrode and a lead body, wherein the lead body is rigid prior to and during insertion;

making the lead body non-rigid after insertion and upon exposure to the body tissue; and

stimulating the body tissue using the stimulation electrode.

13. The method of claim 12, wherein making the lead body non-rigid comprises raising a temperature of the lead body, wherein the lead body comprises a plastic material having a glass transition temperature near or below body temperature.

14. The method of claim 12, further comprising lowering a temperature of the lead below room temperature prior to inserting the lead into the body tissue.

15. The method of claim 12, wherein making the lead body non-rigid comprises absorbing water into the lead body to make the lead body less rigid.

16. The method of claim 15, wherein the lead body comprises a cross-linked hydrogel and absorbing water into the lead body comprises absorbing water into the cross-linked hydrogel to make the lead body less rigid.

17. The method of claim 12, wherein making the lead body non-rigid comprises dissolving a portion of the lead body to make the lead body less rigid.

18. The method of claim 17, wherein the lead body comprises a water-soluble material selected from sugars, steroids, anti-inflammatory agents, and antibiotics and dissolving a portion of the lead body comprises dissolving at least a portion of the water-soluble material.

19. A device for stimulating tissue inside a patient'"'"'s body, comprising:

a lead body that is configured and arranged to be substantially rigid outside the patient'"'"'s body and during insertion into the patient'"'"'s body;

at least one stimulating electrode disposed on the lead body; and

means for making the lead body non-rigid after insertion into and exposure to the patient'"'"'s body.

20. The device of claim 19, wherein the means for making the lead body non-rigid is selected from materials that become non-rigid upon exposure to a temperature of the patient'"'"'s body, materials that become non-rigid upon absorption of water from the patient'"'"'s body;

and a lead body that become non-rigid by dissolving a portion of the lead body into the patient'"'"'s body.