Surgical method for implantable head mounted neurostimulation system for head pain

• US 9,884,190 B2
• Filed: 10/09/2015
• Issued: 02/06/2018
• 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, Colvin, Michael Steven, Denault, Claire
• Primary Examiner(s): VOORHEES, CATHERINE M
• Application Number:
  US14/879,943
• Publication Number:
  US 20160030746A1
• Time in Patent Office: 851 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 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/36075 Headache or migraine
• 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 1/3787 from an external energy source

Abstract

A method for subcutaneously treating pain in a patient includes first providing a neurostimulator with an IPG body and at least a primary integral lead with electrodes disposed thereon. A primary incision is opened to expose the subcutaneous region below the dermis in a selected portion of the body. A pocket is then opened for the IPG through the primary incision and the primary integral lead is inserted through the primary incision and routed subcutaneously to a first desired nerve region along a first desired path. The IPG is disposed in the pocket through the primary incision. The primary incision is then closed and the IPG and the electrodes activated to provide localized stimulation to the desired nerve region and at least one of the nerves associated therewith to achieve a desired pain reduction response from the patient.

Claims

1. A method for treating patients with migraine headaches, comprising the steps of:

subcutaneously implanting at least one neurostimulator control system through an incision in the cranial region, which neurostimulator control system includes a main body disposed proximate the incision having a processor disposed therein and an interface interfacing to at least one integrated stimulating lead, and the at least one integrated stimulating lead having a proximal end connected to the interface and an array of electrodes disposed along the length of the at least one integrated stimulating lead proximate the distal end thereof and interfaced through internal wires to the processor through the interface, the step of implanting further extending the distal end of the integrated stimulating lead subcutaneously from the neurostimulator control system to the frontal cranial region so that at least one of the electrodes is proximate and over a nerve; and

applying, after extending the distal end of the at least one integrated stimulating lead, at least one stimulating signal by the processor in the main body through the internal wires in the at least one integrated stimulating lead to the electrode proximate the at least one nerve, thereby at least in part alleviating pain associated with migraine headaches;

wherein the at least one nerve is selected from at least one of the body, branches and roots of at least one of the supraorbital nerves.

2. The method of claim 1, wherein the incision is made proximate the parietal bone.

3. The method of claim 2, wherein the incision is distal and above the pinna.

4. The method of claim 1, wherein a subcutaneous pocket is created through the incision to contain the neurostimulator control system.

5. The method of claim 1, wherein the neurostimulator control system includes a power source and an internal communication system.

6. The method of claim 5, and further comprising interfacing an external communication system with the internal communication system to transmit signals thereto, wherein the transmission of signals to the internal communication system causes the processor to apply the at least one stimulating signal.

7. The method of claim 1, wherein the interface interfaces to at least another integrated stimulating lead, and the at least another integrated stimulating lead having a proximal end connected to the interface and an array of electrodes disposed along the length of the at least another integrated stimulating lead proximate the distal end thereof and interfaced through internal wires to the processor through the interface, the step of implanting further extending the distal end of the at least another integrated stimulating lead subcutaneously from the neurostimulator control system to the occipital region so that at least one of the electrodes thereof is proximate and over a nerve and wherein the nerve is selected from at least one of the body, branches and roots of at least one of the occipital nerves.

8. The method of claim 1, wherein the incision is closed prior to the step of applying the at least one stimulating signal.

9. The method of claim 1, wherein the at least one integrated stimulating lead includes a second array of electrodes with at least one of the electrodes in the second array disposed over at least one nerve which is selected from at least one of the body, branches and roots of at least one of the auriculo-temporal nerves.