Treatment Devices with Delivery-Activated Inflatable Members, and Associated Systems and Methods for Treating the Spinal Cord and Other Tissues

• US 20090264973A1
• Filed: 04/16/2008
• Published: 10/22/2009
• Est. Priority Date: 04/16/2008
• Status: Active Grant

• Current Assignee: Nevro Corporation
• Original Assignee: Nevro Corporation
• Inventors: Boling, C. Lance, Makous, James
• Granted Patent: US 8,326,439 B2
• Time in Patent Office: Days
• US Class Current: 607/117
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

Treatment systems with delivery-activated inflatable members, and associated systems and methods for treating the spinal cord and other tissues are disclosed. A treatment system in accordance with one embodiment includes a lead body having an opening, an inner surface position around the opening, and an inflatable member carried by the lead body, with at least one of the inflatable member and the lead body including a frangible portion accessible from the opening. The inflatable member can have an expandable interior volume bounded at least in part by the frangible portion. The system can further include a delivery device received in the opening of the lead body and positioned to open a passage through the frangible portions between the interior volume of the inflatable member and the opening of the lead body when the delivery device is removed from the opening of the lead body.

Claims

1. A patient treatment system, comprising:

a lead body having an opening and an inner surface positioned around the opening;

an inflatable member carried by the lead body, with at least one of the inflatable member and the lead body including a frangible portion accessible from the opening, the inflatable member having an expandable interior volume bounded at least in part by the frangible portion; and

a delivery device received in the opening of the lead body, the delivery device being positioned to open a passage through the frangible portion between the interior volume of the inflatable member and the opening of the lead body when the delivery device is removed from the opening of the lead body.

2. The treatment system of claim 1 wherein the frangible portion is adhesively coupled to the delivery device.

3. The treatment system of claim 1 wherein the delivery device includes a sharp element positioned to puncture the frangible portion as the delivery device is withdrawn from the opening of the lead body.

4. The treatment system of claim 1 wherein the lead body is elongated along an axis and wherein the opening is aligned along the axis.

5. The treatment system of claim 1 wherein an exterior surface of the inflatable body includes roughness elements positioned to contact and engage with adjacent patient tissue.

6. The treatment system of claim 1 wherein the inflatable member is one of multiple inflatable members carried by the lead body.

7. The treatment system of claim 1, further comprising a self-inflating material positioned in the interior volume of the inflatable member.

8. The treatment system of claim 1 wherein the lead body and the inflatable member form a unitary structure.

9. The treatment system of claim 1 wherein the self-inflating material is evacuated while the delivery device is received in the opening of the lead body and the frangible portion is closed.

10. The treatment system of claim 1, further comprising at least one electrical contact carried by the inflatable member and movable with the inflatable member as the inflatable member changes between an inflated and deflated configuration.

11. The treatment system of claim 1, further comprising at least one electrical contact carried by the lead body and spaced apart from the inflatable member.

12. A patient treatment system, comprising:

a lead body having an opening and an inner surface positioned around the opening;

an inflatable member carried by the lead body, with at least one of the inflatable member and the lead body including a frangible portion accessible from the opening, the inflatable member having an expandable interior volume bounded at least in part by the frangible portion; and

an electrical contact carried by the inflatable member.

13. The treatment system of claim 12, further comprising a delivery device slideably received in the opening of the lead body.

14. The treatment system of claim 12 wherein the inflatable member includes an exterior surface carrying the electrical contact, and wherein the frangible portion is structurally weaker than the exterior surface, and wherein the system further includes a self-inflating material in the interior volume.

15. The treatment system of claim 12 wherein the frangible portion is the weakest portion of the inflatable member.

16. A method for positioning a delivery lead in a patient, comprising:

percutaneously passing a lead into the patient'"'"'s body while the lead is carried by a delivery device, the lead having an inflatable volume, the delivery device being received in an opening of the lead;

forming a passage between the opening in the lead and the inflatable volume by at least partially removing the delivery device from the opening; and

expanding the inflatable volume.

17. The method of claim 16 wherein forming a passage includes tearing a wall between the opening in the lead and the inflatable volume by at least partially removing the delivery device from the opening.

18. The method of claim 16 wherein expanding the inflatable volume includes directing a flowable material into the opening and through the passage into the inflatable volume.

19. The method of claim 18 wherein expanding the inflatable volume includes directing a liquid into the inflatable volume.

20. The method of claim 18 wherein expanding the inflatable member includes directing at least one of a gas, a foam, a liquid, a gel, and a curable material into the inflatable volume.

21. The method of claim 16 wherein expanding the inflatable volume includes allowing a self-expanding material within the inflatable volume to expand after the passage has been formed.

22. The method of claim 16 wherein forming a passage includes puncturing a material bounding the inflatable volume.

23. The method of claim 16 wherein forming a passage includes disrupting an adhesive between the lead and the delivery device.

24. The method of claim 16 wherein expanding the inflatable member includes positioning the inflatable member against adjacent tissue to at least restrict motion between the treatment lead and the tissue.

25. The method of claim 24 wherein positioning the inflatable member against adjacent tissue includes positioning the inflatable member against bone tissue.

26. The method of claim 24 wherein the inflatable member carries an electrical contact, and wherein positioning the inflatable member against the adjacent tissue includes positioning the electrical contact against the adjacent tissue.

27. The method of claim 16 wherein the lead body has an electrical contact, and wherein passing the lead into the patient'"'"'s body includes positioning the electrical contact in electrical communication with neurons in a spinal cord region of the patient.

28. The method of claim 27 wherein the neurons include spinal cord neurons.

29. The method of claim 27 wherein the neurons include dorsal root neurons.

30. The method of claim 27 wherein passing the lead into the patient'"'"'s body includes positioning the lead in a gutter along the spinal cord.

31. The method of claim 27 wherein passing the lead into the patient'"'"'s body includes positioning the lead in a dorsal root entry zone.

32. A method for manufacturing a patient treatment system, comprising:

positioning a delivery device proximate to a lead body; and

juxtaposing the delivery device and the lead body with the delivery device located within an opening of a lead body, so that removal of the delivery device from the opening forms a fluid passage between the opening and an interior volume of an expandable member carried by the lead body.

33. The method of claim 32 wherein juxtaposing includes positioning a frangible portion of the lead body adjacent to the delivery device.

34. The method of claim 32, further comprising adhering the lead body to the delivery device.

35. The method of claim 32, further comprising collapsing the expandable member around the delivery device.

36. The method of claim 35, further comprising collapsing the self-expanding material within the expandable member as the expandable member is collapsed around the delivery device.

37. The method of claim 35, further comprising evacuating the expandable member prior to inserting delivery device in the lead body.