Method of manufacturing a thin film leadless neurostimulator

• US 9,572,985 B2
• Filed: 06/27/2016
• Issued: 02/21/2017
• Est. Priority Date: 08/27/2014
• Status: Active Grant

• Current Assignee: Aleva Neurotherapeutics
• Original Assignee: Aleva Neurotherapeutics
• Inventors: Mercanzini, Andre
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US15/194,033
• Publication Number:
  US 20160303375A1
• Time in Patent Office: 239 Days
• Field of Search: 607/45
• US Class Current: 1/1
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0534 Electrodes for deep brain stimulation
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37229 Shape or location of the implanted or external antenna
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

The present disclosure describes a medical device to provide neurostimulation therapy to a patient'"'"'s brain. The device can be surgically implanted and can remain in the patient until end of life. The present disclosure also describes accessories which guide the implantation of the device, and the components that form a leadless stimulator implantation kit.

Claims

1. A method of manufacturing an implantable neurostimulator, the method comprising:

forming a MEMS film comprising a plurality of electrodes and a ribbon cable extending from a distal end of the MEMS film;

coupling a stimulation source with a first plurality of contacts, the first plurality of contacts disposed on a first face of the ribbon cable and in electrical communication with at least one of the plurality of electrodes;

coupling a power supply with a second plurality of contacts, the second plurality of contacts disposed on a second face of the ribbon cable;

folding the ribbon cable toward a face of the MEMS film; and

forming, with the MEMS film, a lumen, the ribbon cable disposed within the lumen.

2. The method of claim 1, further comprising coupling a recording circuit on a third plurality of contacts disposed on the first face of the ribbon cable.

3. The method of claim 1, wherein the first face of the ribbon cable is different than the second face of the ribbon cable.

4. The method of claim 1, further comprising filling the lumen with an encapsulating epoxy.

5. The method of claim 1, comprising:

coupling a lead wire with a tether contact, the tether contact disposed toward a distal tip of the ribbon cable.

6. The method of claim 1, further comprising heat molding the MEMS film to form the lumen.

7. The method of claim 1, wherein the power supply comprises a capacitor.

8. The method of claim 1, wherein the MEMS film includes a first polymeric layer, a metal layer, and a polymeric barrier layer.

9. The method of claim 8, wherein the MEMS film includes a first barrier layer and a second barrier layer.

10. The method of claim 9, wherein the first and second barrier layer comprise titanium and the metal layer comprises platinum.

11. The method of claim 9, wherein the first and second barrier layers comprise at least one of Silicon Nitride, Silicon Oxide, Silicon Carbide, Poly-Silicon, and Amorphous-Silicon.

12. The method of claim 8, wherein the metal layer comprises at least one of gold, platinum, titanium, and copper.

13. The method of claim 8, wherein the metal layer is between 200 nm and 400 nm thick.

14. The method of claim 1, comprising:

a gold layer deposited on each of the first plurality of contacts and the second plurality of contacts.

15. The method of claim 1, comprising:

coupling an antenna to the MEMS film, the antenna configured to operate at a center frequency of one of 6.790 MHz, 13.560 MHz, 27.120 MHz, 40.680 MHz, 433.920 MHz, 915.000 MHz, 2.450 GHz, 5.800 GHz, and 24.125 GHz.

16. The method of claim 1, comprising:

wirelessly charging the power supply.

17. The method of claim 1, comprising:

setting a first subset of the plurality of electrodes as recording electrodes; and

setting a second subset of the plurality of electrodes as stimulating electrodes.

18. The method of claim 1, comprising:

coupling a distal tip with a distal end of the MEMS film.

19. The method of claim 18, comprising:

coupling a tether to the distal tip.

20. The method of claim 19, comprising:

disposing an antenna within the tether.