SYSTEMS AND METHODS FOR MAKING AND USING BENDABLE PADDLES WITH IMPLANTABLE ELECTRICAL STIMULATION SYSTEMS

• US 20110172751A1
• Filed: 01/06/2011
• Published: 07/14/2011
• Est. Priority Date: 01/14/2010
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Lee, Dongchul
• Granted Patent: US 8,849,414 B2
• Time in Patent Office: Days
• US Class Current: 607/116
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy

Abstract

An implantable paddle lead includes a paddle body coupled to a distal end of an elongated lead body. A plurality of contacts are disposed on a front surface of the paddle body. At least one manually bendable shape-retaining member is interconnected with the paddle body. The at least one shape-retaining member is formed from a deformable material that is stiff enough to maintain a given shape for at least one day. The at least one bendable shape-retaining member is interconnected with the paddle body such that bending the at least one shape-retaining member causes a corresponding bend of at least a portion of the paddle body in proximity to the at least one shape-retaining member.

Claims

1. An implantable paddle lead comprising:

an elongated lead body with a proximal end and a distal end;

a plurality of terminals disposed at the proximal end of the lead body;

a paddle body coupled to the distal end of the lead body, the paddle body having a length, a width, and front surface;

a plurality of contacts disposed on the front surface of the paddle body;

at least one manually bendable shape-retaining member interconnected with the paddle body, the at least one shape-retaining member formed from a deformable material that is stiff enough to maintain a given shape for at least one day, wherein the at least one bendable shape-retaining member is interconnected with the paddle body such that bending the at least one shape-retaining member causes a corresponding bend of at least a portion of the paddle body in proximity to the at least one shape-retaining member; and

a plurality of conductors, each conductor electrically coupling at least one of the contacts to at least one of the terminals.

2. The paddle lead of claim 1, wherein the at least one shape-retaining member is interconnected with the paddle body such that the at least one shape-retaining member is disposed at least partially within the paddle body.

3. The paddle lead of claim 1, wherein the at least one shape-retaining member is disposed entirely within the paddle body.

4. The paddle lead of claim 1, wherein the at least one shape-retaining member is disposed entirely external to the paddle body and is coupled thereto.

5. The paddle lead of claim 1, wherein the at least one shape-retaining member extends across at least 75% of the width of the paddle body.

6. The paddle lead of claim 1, wherein the at least one shape-retaining member extends across at least 75% of the of length of the paddle body.

7. The paddle lead of claim 1, wherein the at least one shape-retaining member extends around a portion of the paddle body.

8. The paddle lead of claim 1, wherein the plurality of contacts disposed on the front surface of the paddle body comprises at least one anode and at least one cathode.

9. The paddle lead of claim 1, wherein the deformable material is stiff enough to maintain a given shape for an implantable lifetime of the paddle lead.

10. The paddle lead of claim 1, wherein the deformable material that is separate from and distinct from the paddle lead.

11. An electrical stimulation system comprising

the paddle lead of claim 1;

a control module configured and arranged to electrically couple to the proximal end of the lead body, the control module comprising

a housing, and

an electronic subassembly disposed in the housing; and

a connector for receiving the lead body, the connector having a proximal end, a distal end, and a longitudinal length, the connector configured and arranged to receive the lead body, the connector comprising

a connector housing defining a port at the distal end of the connector, the port configured and arranged for receiving the proximal end of the lead body, and

a plurality of connector contacts disposed in the connector housing, the connector contacts configured and arranged to couple to at least one of the plurality of terminals disposed on the proximal end of the lead body.

12. The electrical stimulation system of claim 11, further comprising a lead extension having a proximal end and a distal end, the connector disposed on the distal end of the lead extension.

13. The electrical stimulation system of claim 12, wherein the proximal end of the lead extension is configured and arranged for insertion into another connector.

14. A method for implanting a paddle lead into a patient, the method comprising:

providing paddle lead comprising an elongated lead body with a proximal end and, a distal end, a plurality of terminals disposed on the proximal end of the lead body, a substantially-planar paddle body coupled to the distal end of the lead body, the paddle body having a length, a width, and front surface, a plurality of contacts disposed on the front surface of the paddle body, at least one bendable shape-retaining member interconnected with the paddle body, the at least one shape-retaining member formed from a deformable material that is stiff enough to maintain a given shape for an implantable lifetime of the paddle lead, and a plurality of conductors, each conductor electrically coupling at least one of the contacts to at least one of the terminals

bending the at least one shape-retaining member to conform to at least a portion of an anatomical structure within the patient, wherein bending the at least one shape-retaining member causes a corresponding bend of at least a portion of the substantially-planar paddle body in proximity to the at least one shape-retaining member; and

inserting the paddle lead into the patient such that at least a portion of the paddle body abuts the anatomical structure.

15. The method of claim 14, further comprising transmitting an electrical signal from the control module to at least one of the contacts to electrically stimulate the anatomical structure.

16. The method of claim 14, wherein bending the at least one shape-retaining member to conform to at least a portion of the anatomical structure within the patient comprises bending the at least one shape-retaining member to conform to at least a portion of the patient'"'"'s dura mater.

17. The method of claim 14, wherein inserting the paddle lead into the patient such that at least a portion of the paddle body abuts the anatomical structure comprises inserting the paddle lead into the patient such that at least one of the contacts abuts the anatomical structure.

18. The method of claim 17, wherein bending the at least one shape-retaining member to conform to at least a portion of the anatomical structure within the patient comprises bending the at least one shape-retaining member to direct at least one of the plurality of contacts towards a target stimulation region in, on, or in proximity to the anatomical structure.

19. The method of claim 18, wherein inserting the paddle lead into the patient such that at least one of the contacts abuts the anatomical structure comprises inserting the paddle lead into the patient such that at least one cathode and at least one anode abut the anatomical structure.

20. The method of claim 19, wherein inserting the paddle lead into the patient such that at least one cathode and at least one anode abut the anatomical structure comprises inserting the paddle lead into the patient such that at least one of the at least one cathodes and at least one of the at least one anodes are disposed along a given width of the paddle body and are positioned a similar distance from the target stimulation region.