MEDICAL LEADS WITH SEGMENTED ELECTRODES AND METHODS OF FABRICATION THEREOF

• US 20150157851A1
• Filed: 11/14/2014
• Published: 06/11/2015
• Est. Priority Date: 12/05/2013
• Status: Active Grant

• Current Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Advanced Neuromodulation Systems Incorporated (Abbott Laboratories Incorporated)
• Inventors: Mitchell, Jeffrey, Wilson, Kevin, Sefkow, Ryan, Crawford, Christopher A., Bray, Raymond P., Gonzalez, John R.
• Granted Patent: US 9,370,653 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: B29C 2045/14524 making hollow articles
• CPC Class Codes: B29C 2793/009 after shaping
• CPC Class Codes: B29C 45/0055 Shaping
• CPC Class Codes: B29C 45/14311 using means for bonding the coating to the articles B29C45/14795 takes precedence
• CPC Class Codes: B29C 45/14467 Joining articles or parts of a single article B29C45/14377, B29C45/14385, B29C45/14581, B29C45/14614 and B29C45/006 take precedence
• CPC Class Codes: B29C 45/14565 at spaced locations, e.g. coaxial-cable wires
• CPC Class Codes: B29C 45/14614 Joining tubular articles
• CPC Class Codes: B29C 45/14639 for obtaining an insulating effect, e.g. for electrical components
• CPC Class Codes: B29K 2075/00 Use of PU, i.e. polyureas or polyurethanes or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2995/0056 Biocompatible, e.g. biopolymers or bioelastomers
• CPC Class Codes: B29L 2031/7546 Surgical equipment

Abstract

In one embodiment, a method for fabricating a neurostimulation stimulation lead comprises: providing a plurality of ring components and hypotubes in a mold; placing an annular frame with multiple lumens over distal ends of the plurality of hypotubes to position a portion of each hypotube within a respective lumen of the annular frame; molding the plurality of ring components and the hypotubes to form a stimulation tip component for the stimulation lead, wherein the molding fills interstitial spaces between the plurality of ring components and hypotubes with insulative material; and forming segmented electrodes from the ring components after performing the molding.

Claims

1. A method for fabricating a neurostimulation stimulation lead comprising:

providing a plurality of ring components and hypotubes in a mold;

placing an annular frame with multiple lumens over proximal ends of the plurality of hypotubes to position a portion of each hypotube within a respective lumen of the annular frame;

molding the plurality of ring components and the hypotubes to form a stimulation tip component for the stimulation lead, wherein the molding fills interstitial spaces between the plurality of ring components and hypotubes with insulative material; and

forming segmented electrodes from the ring components after performing the molding.

2. The method of claim 1 wherein the plurality of hypotubes extend from the annular frame structure after the molding is performed.

3. The method of claim 2 wherein multiple ones of the plurality of hypotubes extend different lengths after the molding is performed.

4. The method of claim 1 further comprising:

applying a first weld and a second weld to attach each hypotube to a corresponding ring component.

5. The method of claim 1 wherein an insulative coating is disposed on each hypotube of the plurality of hypotubes.

6. The method of claim 5 wherein the insulative coating on each hypotube is one or more respective polyxylylene polymers.

7. The method of claim 1 wherein an insulative coating is disposed on an inner diameter of the segmented electrodes.

8. The method of claim 7 further comprising:

welding conductor wires of a lead body to each hypotube coated with the one or more polyxylylene polymers.

9. The method of claim 1 further comprising:

joining a lead body to the stimulation tip.

10. The method of claim 9 wherein the joining comprises:

connecting a plurality of wires of the lead body to the hypotubes.

11. The method of claim 10 further comprising:

placing a clam-shell shaped component of reflowable insulative material over the connection region between the plurality of wires and the hypotubes; and

reflowing the material of the clam-shell component.

12. The method of claim 1 wherein each ring component comprises a step-down region that is secured underneath an outer surface of insulative material of the stimulation tip.

13. The method of claim 12 wherein the step-down region comprises a roughened surface.

14. The method of claim 13 further comprising:

bead blasting the step-down region of each ring component to roughen the surface of the step-down region.

15. The method of claim 1 further comprising:

twisting a lead body for the stimulation lead from a first configuration with linearly arranged conductor wires to obtain a second configuration with helically arranged conductor wires.

16. The method of claim 15 further comprising:

heat setting the lead body to retain the second configuration with helically arranged conductor wires.

17. A neurostimulation lead for implant within a body of a patient for stimulation of neural tissue of the patient, the neurostimulation lead comprising:

a lead body comprising a plurality of conductor wires; and

a molded stimulation tip end comprising a plurality of segmented electrodes, hypotubes, and an annular frame structure;

wherein (i) the hypotubes are connected to respective electrodes, the annular frame structure comprises a plurality of lumens with respective hypotubes disposed within corresponding lumens, and the hypotubes are connected to respective ones of the plurality of conductor wires of the lead body.

18. The neurostimulation lead of claim 17 wherein the plurality of conductor wires are disposed in a helical configuration within the lead body.

19. The neurostimulation lead of claim 17 wherein the plurality of hypotubes extend from the stimulation tip end in respective staggered lengths.

20. The neurostimulation lead of claim 17 wherein the plurality of hypotubes and an inner diameter of each electrode are coated with one or more respective polyxylylene polymers.

21. A neurostimulation system, comprising:

an implantable pulse generator for generating electrical pulses to application to tissue of a patient;

a neurostimulation lead for implant within a body of a patient for stimulation of neural tissue of the patient, the neurostimulation lead comprising;

a lead body comprising a plurality of conductor wires; and

a molded stimulation tip end comprising a plurality of segmented electrodes, hypotubes, and an annular frame structure;

wherein the hypotubes are connected to respective electrodes, the annular frame structure comprises a plurality of lumens with respective hypotubes disposed within corresponding lumens, and the hypotubes are connected to respective ones of the plurality of conductor wires of the lead body.

22. The neurostimulation system of claim 21 wherein the plurality of conductor wires are disposed in a helical configuration within the lead body.

23. The neurostimulation system of claim 21 wherein the plurality of hypotubes extend from the stimulation tip end in respective staggered lengths.

24. The neurostimulation system of claim 21 wherein the neurostimulation lead comprises a non-symmetric hour-glass radial marker.