Method of making an electrical stimulation lead

• US 9,566,747 B2
• Filed: 07/15/2014
• Issued: 02/14/2017
• Est. Priority Date: 07/22/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Romero, Daniel James, Howard, Joshua Dale
• Primary Examiner(s): Lee, Edmund
• Application Number:
  US14/332,212
• Publication Number:
  US 20150021817A1
• Time in Patent Office: 945 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: B29C 2045/14122 using fixed mould wall projections for centering the insert
• CPC Class Codes: B29C 2045/14131 using positioning or centering means forming part of the insert
• CPC Class Codes: B29C 2045/1454 injecting between inserts not being in contact with each other
• CPC Class Codes: B29C 33/12 with incorporated means for positioning inserts, e.g. labels positioning reinforcements B29C70/541
• CPC Class Codes: B29C 45/14065 Positioning or centering articles in the mould
• 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 45/14639 for obtaining an insulating effect, e.g. for electrical components
• CPC Class Codes: B29C 45/14811 Multilayered articles B29C45/14827 takes precedence
• CPC Class Codes: B29C 70/681 Component parts, details or accessories; Auxiliary operations
• CPC Class Codes: B29C 70/84 by moulding material on preformed parts to be joined joining plastic parts by moulding B29C65/70
• CPC Class Codes: B29K 2101/12 Thermoplastic materials
• CPC Class Codes: B29K 2715/00 Condition, form or state of preformed parts, e.g. inserts
• CPC Class Codes: B29K 2995/0005 Conductive
• CPC Class Codes: B29K 2995/0056 Biocompatible, e.g. biopolymers or bioelastomers
• CPC Class Codes: B29L 2031/753 Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008
• CPC Class Codes: B29L 2031/7546 Surgical equipment

Abstract

A lead with segmented electrodes can be made using one or two mold methods. In one method, segmented electrodes are individually disposed on pins on an interior surface within a mold. Each of the segmented electrodes has at least one opening formed in the exterior surface of the segmented electrode. The lead body is then molded between the electrodes. In a two mold method, segmented electrodes are inserted into electrode slots of a first mold and an interior portion of a lead body is formed. The resulting intermediate arrangement is placed into a second mold to form an exterior portion of the lead body. In another two mold method, a sacrificial ring is formed around the segmented electrodes in a first mold and the resulting intermediate structure is inserted in a second mold to form the lead body. The sacrificial ring is then removed.

Claims

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

individually disposing a plurality of segmented electrodes on a plurality of pins disposed on an interior surface within a mold, wherein each of the segmented electrodes has at least one opening formed in an exterior surface of the segmented electrode to receive at least one of the pins so that the segmented electrodes can be positioned in a predetermined arrangement within the mold with the segmented electrodes spaced apart from each other;

attaching a conductor wire to each of the segmented electrodes;

molding a lead body between the segmented electrodes disposed in the mold; and

removing the lead body, segmented electrodes, and conductors from the mold.

2. The method of claim 1, further comprising, prior to molding the lead body, inserting a cylindrical body into the mold to hold the segmented electrodes against the interior surface of the mold.

3. The method of claim 2, wherein the cylindrical body is a tube with a central lumen.

4. The method of claim 1, further comprising placing at least one ring electrode or tip electrode in the mold, wherein molding a lead body further comprises molding the lead body between the segmented electrodes and the at least one ring electrode or tip electrode.

5. The method of claim 1, wherein individually disposing a plurality of segmented electrodes comprises forming at least one set of segmented electrodes from the plurality of segmented electrodes, wherein the segmented electrodes of each set are distributed circumferentially around the mold at a same longitudinal position within the mold.

6. The method of claim 1, further comprising, after removal from the mold, filling the at least one opening in the segmented electrodes.

7. A method of making an electrical stimulation lead, the method comprising:

individually inserting a plurality of segmented electrodes into a plurality of electrode slots formed on an interior surface within a first mold;

attaching a conductor wire to each of the segmented electrodes;

molding an interior portion of a lead body between the segmented electrodes disposed in the first mold to form an intermediate arrangement;

removing the intermediate arrangement from the first mold;

placing the intermediate arrangement into a second mold; and

molding an exterior portion of the lead body over the interior portion of the lead body and between the segmented electrodes within the second mold.

8. The method of claim 7, wherein the interior portion and the exterior portion are formed of different materials.

9. The method of claim 7, further comprising, prior to molding the interior portion of lead body, inserting a cylindrical body into the first mold to hold the segmented electrodes against the interior surface of the first mold.

10. The method of claim 9, wherein the cylindrical body is a tube with a central lumen.

11. The method of claim 7, wherein each electrode slot of the first mold defines at least one slot extension extending into an adjacent part of the first mold and each of the segmented electrodes comprises at least one electrode extension, and wherein inserting a plurality of segmented electrodes comprises inserting the at least one electrode extension of the segmented electrodes into the at least one slot extensions of the electrode slots of the first mold.

12. The method of claim 11, wherein each electrode slot has two opposing slot extensions.

13. The method of claim 7, further comprising placing at least one ring electrode or tip electrode in the first mold, wherein molding an interior portion of a lead body further comprises molding the interior portion of the lead body between the segmented electrodes and the at least one ring electrode or tip electrode.

14. The method of claim 7, wherein individually inserting a plurality of segmented electrodes comprises forming at least one set of segmented electrodes from the plurality of segmented electrodes, wherein the segmented electrodes of each set are distributed circumferentially around the first mold at a same longitudinal position within the first mold.