Neural stimulation lead fixation

• US 7,856,277 B1
• Filed: 08/11/2006
• Issued: 12/21/2010
• Est. Priority Date: 05/29/2001
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Thacker, James R., McGivern, James P., Peterson, David K. L., Colvin, Michael S
• Primary Examiner(s): Bertram; Eric D.
• Application Number:
  US11/464,137
• Time in Patent Office: 1,593 Days
• Field of Search: 607/117, 607/116, 604/102.03, 60410306-10307, 604/103.11
• US Class Current: 607/117
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor

Abstract

An implantable lead having at least one electrode contact at or near its distal end prevents undesirable movement of the electrode contact from its initial implant location. One embodiment relates to a spinal cord stimulation (SCS) lead. A first injectable material is injected into the dura space to mechanically position the electrode array with respect to the spinal cord. Conjunctively for use with adhesives, or alternatively for use instead of the adhesives, a balloon may be positioned on the electrode lead array. The balloon is filled with air, liquid or a compliant material. When inflated, the balloon stabilizes the lead with respect to the spinal cord and holds the lead in place. An elastic aspect of the balloon serves as a contained relief valve to limit the pressure the balloon may place on the surrounding tissues when the epidural space is constrained.

Claims

1. An implantable lead comprising:

a flexible carrier;

a lumen passing longitudinally through or along side the flexible carrier;

at least one electrode contact carried on the flexible carrier at or near a distal end of the lead;

a first orifice near the at least one electrode contact that is in fluid communication with the lumen;

a second orifice distal to the first orifice and providing fluid communication between the lumen and an exterior of the lead; and

an inflatable balloon integral with the flexible carrier and opposite the first orifice, said inflatable balloon including a first portion, and a pressure relief portion, wherein the pressure relief portion has a different elasticity than the first portion, wherein the inflatable balloon is configured and arranged to receive a fluid material injectable through said lumen and first orifice that inflates said inflatable balloon until said at least one electrode contact is in contact with surrounding tissue;

wherein the balloon further comprises two attachment portions that are attached to the flexible carrier with the pressure relief portion and the first portion disposed between the two attachment portions and configured and arranged to be spaced apart from the flexible carrier when the balloon is inflated.

2. The implantable lead of claim 1 wherein the fluid material comprises air.

3. The implantable lead of claim 1 wherein the fluid material comprises a liquid.

4. The implantable lead of claim 1 wherein the fluid material comprises a compliant material.

5. The implantable lead of claim 1 wherein the at least one electrode contact comprises a plurality of spaced-apart electrode contacts, and wherein the implantable lead is adapted to connect to a spinal cord stimulation system.

6. The implantable lead of claim 1 wherein the inflatable balloon covers an area at a distal end of said flexible carrier that, when the flexible carrier is viewed in cross section, extends over an angle α

of between 20 to 270 degrees.

7. The implantable lead of claim 1 wherein the lead comprises a plurality of said inflatable balloons forming at least one sequence of individual inflatable lobe balloons, each sequence comprising at least two of the plurality of inflatable balloons which are associated with a one of the electrode contacts and disposed around a circumference of the lead at a same longitudinal position along the lead.

8. The implantable lead of claim 7 wherein the number of inflatable lobe balloons in each sequence of inflatable lobe balloons is three.

9. An implantable lead comprising:

a flexible carrier;

a lumen passing longitudinally through or along side the flexible carrier;

at least one electrode contact carried on the flexible carrier at or near a distal end of the lead;

a first orifice near the at least one electrode contact that is in fluid communication with the lumen;

a second orifice distal to the first orifice and providing fluid communication between the lumen and an exterior of the lead; and

an inflatable balloon integral with the flexible carrier and opposite the first orifice, said inflatable balloon including a first portion, and a pressure relief portion, wherein the pressure relief portion has a different elasticity than the first portion, wherein the inflatable balloon is configured and arranged to receive a fluid material injectable through said lumen and first orifice that inflates said inflatable balloon until said at least one electrode contact is in contact with surrounding tissue;

wherein the first portion and the pressure relief portion of the inflatable balloon have inflatable walls made from the same material, and wherein the inflatable walls of the pressure relief portion are thicker, prior to inflation of the balloon, than the inflatable walls of the first portion.

10. An implantable lead comprising:

a flexible carrier having a distal end and a proximal end, wherein the flexible carrier includes a plurality of helically wound wires, and wherein the wires further define a lumen that passes longitudinally through said flexible carrier;

an electrode array comprising a plurality of spaced-apart electrode contacts near or at the distal end of the flexible carrier, and wherein the plurality of helically wound wires make electrical contact with the electrode contacts from a proximal end of the lead;

a first orifice near the at least one electrode contact that is in fluid communication with the lumen;

a second orifice distal to the first orifice and providing fluid communication between the lumen and a region exterior to the lead; and

lead fixation means on the flexible carrier at or near its distal end for securing the location of the lead relative to tissue within which the implantable neural lead may be implanted, said lead fixation means including a first portion and a pressure relief portion for limiting the amount of pressure that may be exerted by the lead fixation means, wherein the pressure relief portion has a different elasticity than the first portion, wherein the lead fixation means is configured and arranged to receive a fluid material injectable through said lumen and first orifice that inflates said lead fixation means until said at least one electrode contact is in contact with surrounding tissue;

wherein the lead fixation means further comprises two attachment portions that are attached to the flexible carrier with the pressure relief portion and the first portion disposed between the two attachment portions and configured and arranged to be spaced apart from the flexible carrier when the lead fixation means is inflated.

11. The implantable lead of claim 10 wherein the fluid material comprises a gas.

12. The implantable lead of claim 10 wherein the fluid material comprises a liquid.

13. The implantable lead of claim 10 wherein the fluid material comprises a compliant material.

14. The implantable lead of claim 10 wherein the implantable lead is adapted to connect to a spinal cord stimulation system.

15. An implantable lead comprising:

a flexible carrier having a distal end and a proximal end, wherein the flexible carrier includes a plurality of helically wound wires, and wherein the wires further define a lumen that passes longitudinally through said flexible carrier;

an electrode array comprising a plurality of spaced-apart electrode contacts near or at the distal end of the flexible carrier, and wherein the plurality of helically wound wires make electrical contact with the electrode contacts from a proximal end of the lead;

a first orifice near the at least one electrode contact that is in fluid communication with the lumen;

a second orifice distal to the first orifice and providing fluid communication between the lumen and a region exterior to the lead; and

lead fixation means on the flexible carrier at or near its distal end for securing the location of the lead relative to tissue within which the implantable neural lead may be implanted, said lead fixation means including a first portion and a pressure relief portion for limiting the amount of pressure that may be exerted by the lead fixation means, wherein the pressure relief portion has a different elasticity than the first portion, wherein the lead fixation means is configured and arranged to receive a fluid material injectable through said lumen and first orifice that inflates said lead fixation means until said at least one electrode contact is in contact with surrounding tissue;

wherein the first portion and the pressure relief portion have inflatable walls made from the same material, and wherein the inflatable walls of the pressure relief portion are thicker, prior to inflation of the lead fixation means, than the inflatable walls of the first portion.