Neural stimulation lead fixation

• US 7,099,718 B1
• Filed: 05/24/2002
• Issued: 08/29/2006
• Est. Priority Date: 05/29/2001
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Advanced Bionics Corporation (Sonova Holding AG)
• Inventors: L. Peterson, David K., Thacker, James R., McGivern, James P., Colvin, Michael S.
• Primary Examiner(s): Evanisko, George R.
• Assistant Examiner(s): FILOSI, TERRI LYNN
• Application Number:
  US10/155,146
• Time in Patent Office: 1,558 Days
• Field of Search: 607116-118, 607/126, 607120-121
• 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 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. The pressure of the balloon is monitored or otherwise controlled during the filling process in order to determine at what point the filling process should be discontinued. 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 neural 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;

a plurality of spaced-apart electrode contacts near or at the distal end of the flexible carrier, wherein each wire makes electrical contact with each spaced-apart electrode contact from the proximal end of the flexible carrier; and

a compressible, flexible material formed on the flexible carrier at or near its distal end, wherein the compressible, flexible material is adapted to secure the flexible carrier and electrode contacts in a desired implantable position relative to body tissue, and further wherein the flexible, compressible material includes at least one inflatable balloon formed near the distal end of the flexible carrier, the at least one inflatable balloon having a first portion and a second portion, wherein the second portion has different elasticity than the first portion such that more pressure is required to begin inflating the second portion than is required to begin inflating the first portion, wherein the second portion of the inflatable balloon provides a contained relief valve that limits the pressure in the first balloon portion, and wherein the first portion has a different dilated balloon diameter than the second portion.

2. The implantable neural lead of claim 1 wherein the second portion has thicker walls than does the first portion.

3. The implantable neural lead of claim 2 further including an orifice that opens to the inside of said at least one inflatable balloon and that is in fluid communication with the lumen, wherein said at least one inflatable balloon may be inflated through said lumen and orifice.

4. The implantable neural lead of claim 1 further including

a channel that passes longitudinally through the flexible carrier, said channel being separate from the lumen;

and

an orifice that opens to the inside of said at least one inflatable balloon and that is in fluid communication with said channel, wherein said at least one inflatable balloon may be inflated through said channel and orifice.

5. An implantable neural lead comprising:

a flexible carrier, 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;

a plurality of spaced-apart electrode contacts near or at a distal end of the flexible carrier, wherein each wire makes electrical contact with each spaced-apart electrode contact;

an orifice near or at the distal end of the flexible carrier, wherein said orifice is in fluid communication with the lumen; 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,

at least one inflatable balloon formed near the distal end of the flexible carrier, the at least one inflatable balloon having a first portion and a second portion, wherein the second portion has different elasticity than the first portion such that more pressure is required to begin inflating the second portion than is required to begin inflating the first portion, wherein the second portion of the inflatable balloon provides a contained relief valve that limits the pressure in the first balloon portion, wherein the first portion has a different dilated balloon diameter than the second portion, and wherein the at least one inflatable balloon is inflated through said lumen and orifice.

6. The implantable neural lead of claim 5 wherein the lead fixation means comprises a flexible, compressible portion.

7. The implantable neural lead of claim 5 wherein the second portion has thicker walls than does the first portion.