ELECTRICAL STIMULATION LEADS WITH HELICALLY ARRANGED ELECTRODES AND METHODS OF MAKING AND USING

• US 20150151113A1
• Filed: 12/01/2014
• Published: 06/04/2015
• Est. Priority Date: 12/02/2013
• Status: Active Grant

• Current Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Neuromodulation Corporation (Boston Scientific Corporation)
• Inventors: Howard, Joshua Dale, Govea, Andrew
• Granted Patent: US 9,775,988 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: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: B29C 2045/1673 injecting the first layer, then feeding the insert, then injecting the second layer
• CPC Class Codes: B29C 33/14 against the mould wall
• CPC Class Codes: B29C 39/021 by casting in several steps
• CPC Class Codes: B29C 39/10 incorporating preformed parts or layers, e.g. casting around inserts or for coating articles coating a surface by casting in general B05D1/30, B29C39/126 takes precedence
• CPC Class Codes: B29C 70/682 Preformed parts characterised by their structure, e.g. form
• CPC Class Codes: B29C 70/78 Moulding material on one side only of the preformed part
• 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 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

Abstract

A stimulation lead can include segmented electrodes arranged in a single or double helix or other helical arrangement. In one method of manufacture, an electrode carrier with segmented electrode receiving openings is used. Another method employs a connected framework of helically arranged pre-electrodes that are separated during manufacture. Yet another method employs a mold to generate a planar carrier over the segmented electrodes followed by rolling the carrier into a cylinder. A further method includes forming an electrode assembly by alternative segmented electrodes with non-conducting spacers.

Claims

1. A stimulation lead, comprising:

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

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

a non-conductive electrode carrier coupled to, or disposed along, the distal portion of the lead body, the electrode carrier comprising defining a plurality of segmented electrode receiving openings arranged in a single helix or a double helix;

a plurality of segmented electrodes, each of the segmented electrodes extending around no more than 75% of a circumference of the lead, each of the segmented electrodes disposed in a different one of the segmented electrode receiving openings of the electrode carrier; and

a plurality of conductors extending along the lead body and coupling the plurality of electrodes to the plurality of terminals.

2. The stimulation lead of claim 1, wherein the electrode carrier comprises at least one step within each of the segmented electrode receiving openings to locate and set a depth of the segmented electrode within the electrode carrier.

3. The stimulation lead of claim 2, wherein each of the segmented electrodes comprises at least one channel sized and shaped to fit around a one of the at least one step.

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

disposing a plurality of segmented electrodes and conductors in a first mold;

attaching each of the conductors to one of the segmented electrodes;

molding a carrier over the segmented electrodes using the first mold;

rolling the carrier with the segmented electrodes into a cylinder, wherein the segmented electrodes are arranged in the first mold so that when rolled into a cylinder with the carrier, the segmented electrodes are arranged in a single helix or a double helix;

placing the cylinder into a second mold; and

molding a lead body between the segmented electrodes using the second mold.

12. The method of claim 11, wherein molding the carrier comprises forming a plurality of notches on a surface of the carrier opposite the segmented electrodes.

13. The method of claim 12, wherein each of the notches extends an entire longitudinal length of the carrier and is parallel to the conductors.

14. The method of claim 12, wherein the notches and conductors are arranged in an alternating pattern.

15. The method of claim 11, further comprising placing an over tube over the cylinder prior to placing the cylinder into the second mold.

4. A method of making a stimulation lead, the method comprising:

forming a rib framework comprising a plurality of pre-electrodes attached together in a single or a double helix;

attaching a conductor to each of the pre-electrodes;

disposing the rib framework into a mold and forming a lead body between the pre-electrodes; and

removing a portion of the lead body and the pre-electrodes to generate a plurality of separated segmented electrodes arranged in the single helix or the double helix.

5. The method of claim 4, wherein forming a rib framework comprises forming the rib framework with the pre-electrodes attached to each other at corners of the pre-electrodes.

6. The method of claim 4, wherein forming a rib framework comprises forming the rib framework with the pre-electrodes attached to a helically wound ribbon.

7. The method of claim 4, wherein forming a rib framework comprises forming the rib framework with the pre-electrodes attached to a half-cylinder.

8. The method of claim 7, further comprising forming a cylindrical rib assembly from two of the rib frameworks, wherein disposing the rib framework into the mold comprises disposing the rib assembly into the mold.

9. The method of claim 4, further comprising forming a rib assembly from two of the rib frameworks arranged to provide a double helix of the pre-electrodes, wherein disposing the rib framework into the mold comprises disposing the rib assembly into the mold.

10. The method of claim 4, wherein the rib framework comprises at least one alignment tab and wherein disposing the rib framework into the mold comprises disposing the rib framework into the mold with the at least one alignment tab of the rib framework disposed in a corresponding slot of the mold.

16. A method of making a stimulation lead, the method comprising:

forming an electrode assembly by alternating segmented electrodes with non-conductive spacers shaped to receive the segmented electrodes, wherein the segmented electrodes are positioned in the electrode assembly in a single helix or a double helix;

placing the electrode assembly into a mold; and

molding a lead body between the segmented electrodes using the mold.

17. The method of claim 16, wherein each of the spacers is shaped differently from the other spacers.

18. The method of claim 16, wherein each of the spacers comprises an aligning rib and wherein forming an electrode assembly comprises alternating the segmented electrodes with the non-conductive spacers with the aligning rib of each spacer aligned with the aligning ribs of the other spacers.

19. The method of claim 16, wherein each of the segmented electrode comprises at least one alignment tab and each of the spacers comprises at least one notch, wherein forming an electrode assembly comprises alternating the segmented electrodes with the non-conductive spacers with each of the at least one alignment tab of each of the segmented electrodes disposed in one of the at least one notch of the spacers.

20. The method of claim 19, further comprising removing the at least one alignment tab from each of the segmented electrodes after molding the lead body.