Implantable head mounted neurostimulation system for head pain

• US 9,974,968 B2
• Filed: 05/20/2015
• Issued: 05/22/2018
• Est. Priority Date: 08/14/2013
• Status: Active Grant

• Current Assignee: Shiratronics, Inc.
• Original Assignee: Syntilla Medical LLC
• Inventors: Reed, Kenneth Lyle, Bulger, Robert Raymond
• Primary Examiner(s): VOORHEES, CATHERINE M
• Application Number:
  US14/717,912
• Publication Number:
  US 20150321004A1
• Time in Patent Office: 1,098 Days
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/0526 Head electrodes A61N1/0551 takes precedence
• CPC Class Codes: A61N 1/0529 Electrodes for brain stimulation
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36075 Headache or migraine
• CPC Class Codes: A61N 1/36125 Details of circuitry or electric components
• 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 1/37247 User interfaces, e.g. input or presentation means
• CPC Class Codes: A61N 1/375 Constructional arrangements, e.g. casings
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

An implantable head-mounted unibody peripheral neurostimulation system is provided for implantation in the head for the purpose of treating chronic head pain, including migraine. The system may include an implantable pulse generator (IPG) from which multiple stimulating leads may extend sufficient to allow for adequate stimulation over multiple regions of the head, preferably including the frontal, parietal and occipital regions. A lead may include an extended body, along which may be disposed a plurality of surface metal electrodes, which may be sub-divided into a plurality of electrode arrays. A plurality of internal metal wires may run a portion of its length and connect the IPG'"'"'s internal circuit to the surface metal electrodes. The IPG may include a rechargeable battery, an antenna, and an application specific integrated circuit. The IPG may be capable of functional connection with an external radiofrequency unit for purposes that may include recharging, diagnostic evaluation, and programming.

Claims

1. A head-mounted neurostimulator, comprising:

an implantable pulse generator (IPG), the IPG having;

a first body including circuitry for generating stimulating signals and disposed in a first plane,

a second body including a coil for inductively receiving power and disposed in a second plane so that the first plane is adjacent and non-overlapping the second plane, the coil in the second body being interfaced with the circuitry in the first body, and

a battery for being charged by the circuitry with inductive power received by the coil;

a first lead having a first lead body interfaced with the circuitry in the first body on a proximal end and having a first array of electrodes exposed to the exterior of the first lead body proximate a distal end thereof, each of the electrodes conductively and separately interfaced to the circuitry in the first body through the first lead body to receive simulating signals therefrom;

a second lead having a second lead body interfaced with the circuitry in the first body on a proximal end and having a second array of electrodes exposed to the exterior of the second lead body proximate a distal end thereof, each of the electrodes conductively and separately interfaced to the circuitry in the first body through the second lead body to receive simulating signals therefrom; and

a coating disposed over the first and second bodies and at least a portion of the first and second leads on the proximal ends thereof to form a unibody construction;

wherein the circuitry in the first body is operable to drive the electrodes in the first and second arrays simultaneously, such that select ones of the electrodes can be driven to provide stimulating signals.

2. The head-mounted neurostimulator of claim 1, wherein the stimulating signals include pulsed signals.

3. The head-mounted neurostimulator of claim 2, wherein the stimulating signals pulse at predetermined frequencies.

4. The head-mounted neurostimulator of claim 1, wherein the first and second leads each include a plastic body member and a plurality of internal conducting wires.

5. The head-mounted neurostimulator of claim 4, wherein each of the electrodes is conductively interfaced with one of the internal conducting wires.

6. The head-mounted neurostimulator of claim 4, wherein the first and second leads are flexible.

7. The head-mounted neurostimulator of claim 1, wherein the electrodes in the first array on the first lead are disposed uniformly along a linear portion of the lead at a first inter-electrode interval.

8. The head-mounted neurostimulator of claim 7, wherein the electrodes in the second array on the second lead are disposed uniformly along a linear portion of the lead at a second inter-electrode interval.

9. The head-mounted neurostimulator of claim 8, wherein the first lead has a third array of electrodes, each of the electrodes of the third array conductively interfaced to the circuitry in the first body to receive simulating signals therefrom.

10. The head-mounted neurostimulator of claim 9, wherein the third array of electrodes is disposed uniformly along a linear portion of the first lead at a third inter-electrode interval which is different than the first inter-electrode interval.

11. The head-mounted neurostimulator of claim 9, wherein the circuitry in the first body is operable to drive the first, second, and third arrays simultaneously.

12. The head-mounted neurostimulator of claim 1, wherein the circuitry disposed in the first body is operable to communicate wirelessly, via the coil, with a source external to the IPG.

13. The head-mounted neurostimulator of claim 1, wherein at least one of the electrodes is a cathode.

14. The head-mounted neurostimulator of claim 1, wherein at least one of the electrodes in each of the first and second arrays is an anode and another thereof is a cathode.

15. The head-mounted neurostimulator of claim 2, wherein the stimulating signals pulse at predetermined pulse-widths.

16. The head-mounted neurostimulator of claim 1, wherein the at least one of the electrodes is cylindrical in shape.

17. The head-mounted neurostimulator of claim 1, wherein at least one of the electrodes is flattened in shape.

18. A head-mounted neurostimulator, comprising:

an implantable pulse generator (IPG), the IPG having;

a first body including circuitry for generating stimulating signals and disposed in a first plane,

a second body including a coil for inductively receiving power and disposed in a second plane so that the first plane is adjacent and non-overlapping the second plane, the coil in the second body being interfaced with the circuitry in the first body, and

a battery for being charged by the circuitry with inductive power received by the coil;

a first lead having a first lead body interfaced with the circuitry in the first body on a proximal end and having a first array of electrodes exposed to the exterior of the first lead body proximate a distal end thereof, each of the electrodes conductively and separately interfaced to the circuitry in the first body through the first lead body to receive simulating signals therefrom;

a second lead having a second lead body interfaced with the circuitry in the first body on a proximal end and having a second array of electrodes exposed to the exterior of the second lead body proximate a distal end thereof, each of the electrodes conductively and separately interfaced to the circuitry in the first body through the second lead body to receive simulating signals therefrom; and

a coating disposed over the first and second bodies and at least a portion of the first and second leads on the proximal ends thereof to form a unibody construction;

wherein the circuitry in the first body is operable to drive the first and second arrays simultaneously, such that select ones of the electrodes can be driven to provide stimulating signals; and

wherein the electrodes in each of the first and second arrays are programmed to function as anodes and cathodes.