LEADS WITH PROXIMAL STIFFENING AND RELATED METHODS OF USE AND MANUFACTURE

• US 20160001061A1
• Filed: 09/11/2015
• Published: 01/07/2016
• Est. Priority Date: 12/21/2012
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Leven, Jacob B.
• Granted Patent: US 9,744,345 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: B29C 41/20 incorporating preformed parts or layers, e.g. moulding inserts or for coating articles
• CPC Class Codes: B29K 2063/00 Use of EP, i.e. epoxy resins or derivatives thereof, as moulding material
• CPC Class Codes: B29L 2031/753 Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008

Abstract

An electrical stimulation lead includes a lead body; electrodes disposed along the distal portion of the lead body or on a paddle body coupled to the lead body; terminals disposed along the proximal portion of the lead body; and conductors coupling the terminals to the electrodes. The lead also includes a conductor guide disposed within the lead body and extending from the proximal portion of the lead body. The conductor guide defines a central lumen and a plurality of conductor lumens disposed around the central lumen. The lead further includes a stiffening agent disposed within at least one of the conductor lumens. The stiffening agent includes a) a material formed from a granular particulate material, b) a polymeric material having a durometer at least 10% greater than the durometer of the conductor guide, or c) a continuous epoxy layer within which discrete epoxy particles are also disposed.

Claims

1. An electrical stimulation lead, comprising:

a lead body having a distal portion, a proximal portion, and a longitudinal length;

a plurality of electrodes disposed along the distal portion of the lead body or on a paddle body coupled to the lead body;

a plurality of terminals disposed along the proximal portion of the lead body;

a plurality of conductors electrically coupling the plurality of terminals to the plurality of electrodes;

a conductor guide disposed within the lead body and extending from the proximal portion of the lead body along the lead body, the conductor guide defining a central lumen and a plurality of conductor lumens disposed around the central lumen, the central lumen and conductor lumens extending longitudinally along the conductor guide, the conductor lumens having a proximal end and receiving the plurality of conductors within the conductor lumens; and

a stiffening agent disposed within at least one of the conductor lumens from the proximal end to at least a portion of the conductor lumen within which at least one of the conductors is disposed, wherein the stiffening agent comprises discrete epoxy particles and a continuous epoxy layer within which the epoxy particles are disposed.

2. The electrical stimulation lead of claim 1, wherein the stiffening agent is formed by flowing a flowable epoxy material around the epoxy particles and then curing the flowable epoxy material to generate the continuous epoxy layer.

3. The electrical stimulation lead of claim 1, wherein the stiffening agent s also disposed in a portion of the central lumen.

4. The electrical stimulation lead of claim 3, wherein the continuous epoxy layer of the stiffening agent disposed in the central lumen extends to a point distal of all of the terminals.

5. The electrical stimulation lead of claim 3, wherein the continuous epoxy layer of the stiffening agent disposed in the central lumen extends to a point between a distal-most one of the terminals and a proximal end of the central lumen.

6. The electrical stimulation lead of claim 1, wherein the lead comprises the paddle body coupled to a distal end of the lead body, wherein the plurality of electrodes is disposed on the paddle body.

7. The electrical stimulation lead of claim 1, wherein the plurality of electrodes is disposed along the distal portion of the lead body.

8. The electrical stimulation lead of claim 1, wherein the discrete epoxy particles are broken epoxy particles formed by breaking up an epoxy material.

9. The electrical stimulation lead of claim 1, wherein the stiffening agent is disposed within each of the conductor lumens.

10. The electrical stimulation lead of claim 1, wherein the stiffening agent is not disposed in at least one of the conductor lumens.

11. A method of making the electrical stimulation lead of claim 1, the method comprising:

disposing a plurality of conductor wires into a plurality of conductor lumens defined within a conductor guide, the conductor lumens extending longitudinally from a proximal end of the conductor guide, wherein at least one of the conductor lumens defines an open portion that extends distally from the proximal end of the conductor guide and does not contain any portion of the conductor wires;

disposing a plurality of terminals along the proximal portion of the conductor guide in a spaced-apart longitudinal arrangement;

electrically coupling each of the plurality of terminals to at least one of the conductors;

flowing epoxy material into the open portion of at least one of the conductor lumens;

curing the epoxy material;

breaking the cured epoxy material into discrete epoxy particles;

flowing additional epoxy material into the open portion of at least one of the conductor lumens and around the epoxy particles; and

curing the additional epoxy material to form a continuous epoxy layer having the epoxy particles disposed therein.

12. The method of claim 11, wherein the conductor guide further defines a central lumen extending longitudinally from the proximal end of the conductor guide with the conductor lumens disposed circumferentially around the central lumen.

13. The method of claim 12, further comprising

flowing epoxy material into a proximal portion of the central lumen, and

curing the epoxy material in the proximal portion of the central lumen.

14. The method of claim 13, further comprising

breaking the cured epoxy material in the central lumen into discrete epoxy particles.

15. The method of claim 14, further comprising

flowing additional epoxy material into the proximal portion of the central lumen and around the epoxy particles;

and

curing the additional epoxy material to form a continuous epoxy layer having the epoxy particles disposed therein.

16. The method of claim 11, wherein breaking the cured epoxy material comprises rolling the conductor guide over a tool having a desired radius to break the cured epoxy material disposed within the conductor lumens of the conductor guide.

17. An electrical stimulation lead, comprising:

a lead body having a distal portion, a proximal portion, and a longitudinal length;

a plurality of electrodes disposed along the distal portion of the lead body or on a paddle body coupled to the lead body;

a plurality of terminals disposed along the proximal portion of the lead body;

a plurality of conductors electrically coupling the plurality of terminals to the plurality of electrodes;

a conductor guide disposed within the lead body and extending from the proximal portion of the lead body along the lead body, the conductor guide comprising a polymeric material and defining a central lumen and a plurality of conductor lumens disposed around the central lumen, the central lumen and conductor lumens extending longitudinally along the conductor guide, the conductor lumens having a proximal end and receiving the plurality of conductors within the conductor lumens; and

a stiffening agent disposed within at least one of the conductor lumens from the proximal end to at least a portion of the conductor lumen within which at least one of the conductors is disposed, wherein the stiffening agent is a polymeric material having a durometer at least 10% greater than a durometer of the polymeric material of the conductor guide.

18. The electrical stimulation lead of claim 17, wherein the stiffening a gent comprises monofilament.

19. The electrical stimulation lead of claim 17, wherein the polymeric material of the stiffening agent has been melted or reflowed within the conductor lumen.

20. The electrical stimulation lead of claim 17, wherein the durometer of the polymeric material of the stiffening agent is at least 25% greater than the durometer of the polymeric material of the conductor guide.