Leadless neurostimulator

• US 9,889,304 B2
• Filed: 02/07/2017
• Issued: 02/13/2018
• 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:
  US15/426,816
• Publication Number:
  US 20170143982A1
• Time in Patent Office: 371 Days
• Field of Search: 607 45
• 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 neurostimulation device, comprising:

a capsule body comprising a proximal and a distal end;

a MEMS film formed to define a lumen, the MEMS film comprising an exterior portion coupled with the capsule body, a plurality of electrodes, and a contact pad;

an antenna coupled with the MEMS film and configured to receive signals from an external programmer;

a stimulation source coupled with the contact pad of the MEMS film and disposed within the lumen and in electrical communication with at least one of the plurality of electrodes; and

a power supply coupled with the contact pad of the MEMS film and disposed within the lumen and in electrical communication with the stimulation source.

2. The device of claim 1, wherein the MEMS film further comprises the antenna.

3. The device of claim 1, wherein the antenna is a strip antenna or a serpentine antenna.

4. The device of claim 1, comprising:

a tether coupled with the distal end of the capsule body, the tether comprising the antenna.

5. The device of claim 1, wherein the antenna is 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.

6. The device of claim 1, wherein the antenna forms a loop around a burr hole cover frame.

7. The device of claim 1, wherein the antenna comprises one or more wires in electrical communication with the stimulation capsule.

8. The device of claim 7, wherein the one or more wires are each coupled with a wire tether contact disposed on the contact pad.

9. The device of claim 1, comprising:

a ribbon cable coupled between the exterior portion and the contact pad, wherein the ribbon cable extends from a distal end of the MEMS film into the lumen.

10. The device of claim 1, wherein a diameter of the stimulation capsule is less than a diameter of the tether.

11. The device of claim 1, comprising a recording circuit coupled with the contact pad of the MEMS film and disposed in the lumen, the recording circuit in electrical communication with a portion of the plurality of electrodes.

12. The device of claim 1, wherein the power supply is a battery or super-capacitor.

13. The device of claim 1, wherein the MEMS film comprises a first polymeric layer, a first barrier layer, a metal layer, a second barrier layer, and a second polymeric layer.

14. The device of claim 1, wherein the lumen defined by the MEMS film is backfilled with a polymer precursor to form the capsule body.

15. A method, comprising:

implanting, with a guide tube, a neurostimulation device near a target area, the neurostimulation device comprising;

a capsule body comprising a proximal and a distal end;

a MEMS film formed to define a lumen, the MEMS film comprising an exterior portion coupled with the capsule body, a plurality of electrodes, and a contact pad;

an antenna coupled with the MEMS film and configured to receive signals from an external programmer;

a stimulation source coupled with the contact pad of the MEMS film and disposed within the lumen and in electrical communication with at least one of the plurality of electrodes; and

a power supply coupled with the contact pad of the MEMS film and disposed within the lumen and in electrical communication with the stimulation source;

retracting the guide tube;

generating, by the stimulation source, a stimulation signal; and

stimulating, via at least one of the plurality of electrodes, the target area with the stimulation signal.

16. The method of claim 15, comprising:

wirelessly recharging, via the antenna, the power supply.

17. The method of claim 15, wherein the MEMS film further comprises the antenna.

18. The method of claim 15, comprising:

retracting from the target area, by a tether coupled with the neurostimulation device, the neurostimulation device.

19. The method of claim 15, comprising:

programming, wirelessly via the antenna, a stimulation parameter of the neurostimulation device.

20. The method of claim 15, comprising:

receiving, wirelessly via the antenna, recorded physiological data from the neurostimulation device.