Surgical method for implantable head mounted neurostimulation system for head pain

• US 10,258,805 B2
• Filed: 05/18/2017
• Issued: 04/16/2019
• Est. Priority Date: 10/23/2013
• Status: Active Grant

• Current Assignee: Shiratronics, Inc.
• Original Assignee: Syntilla Medical LLC
• Inventors: Reed, Kenneth Lyle, Bulger, Robert Raymond, Colvin, Michael Steven
• Primary Examiner(s): Voorhees, Catherine M
• Application Number:
  US15/599,206
• Publication Number:
  US 20170252568A1
• Time in Patent Office: 698 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 1/37211 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 1/37514 Brain implants
• CPC Class Codes: A61N 1/3758 Packaging of the components within the casing
• 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, a secondary, and a tertiary 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 integral leads are inserted through the primary incision and routed subcutaneously to desired nerve regions along desired paths. 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 regions and at least three 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 a first, second, and third lead of at least three integrated stimulating leads, and each of the at least three integrated stimulating leads having;

a proximal end connected to the interface, and

an array of electrodes disposed along the length of the integrated stimulating lead proximate a distal end thereof and interfaced through internal wires to the processor through the interface;

extending the distal end of the first lead subcutaneously from the neurostimulator control system to the frontal cranial region so that at least one of the electrodes of the first integrated stimulating lead is proximate and over at least one nerve selected from at least one of the body, branches, and roots of at least one supraorbital nerve;

extending the distal end of the second integrated stimulating lead subcutaneously from the neurostimulator control system to the infraorbital cranial region so that at least one of the electrodes of the second lead is proximate and over at least one nerve selected from at least one of the body, branches, and roots of at least one infraorbital nerve;

extending the distal end of the third integrated stimulating lead subcutaneously from the neurostimulator control system to the occipital cranial region so that at least one of the electrodes of the third lead is proximate and over at least one nerve selected from at least one of the body, branches, and roots of at least one occipital nerve; and

applying, after the extension of the first, second, and third integrated stimulating leads, at least one stimulating signal by the processor in the main body through the internal wires in the at least three integrated stimulating leads to the electrodes proximate the at least three nerves, thereby at least in part alleviating pain associated with migraine headaches.

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 a fourth integrated stimulating lead, and the fourth integrated stimulating lead having a proximal end connected to the interface and an array of electrodes disposed along the length of the fourth integrated stimulating lead proximate the distal end thereof and interfaced through internal wires to the processor through the interface, and further comprising the step of extending the distal end of the fourth integrated stimulating lead subcutaneously from the neurostimulator control system to the mandibular region so that at least one of the electrodes of the fourth integrated stimulating lead is proximate and over a nerve selected from at least one of the body, branches and roots of at least one of the mental 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 at least one of the at least three integrated stimulating leads 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.

10. A method for subcutaneously treating pain in a patient, comprising the steps of:

providing a neurostimulator with an implantable pulse generator (IPG) body and at least a primary integral lead, a secondary integral lead, and a tertiary integral lead, each lead with electrodes disposed thereon;

opening a primary incision to expose the subcutaneous region below the dermis in a selected portion of the body;

opening a pocket for the IPG through the primary incision;

inserting the primary integral lead through the primary incision and routing it subcutaneously to a first desired nerve region along a first desired path;

inserting the secondary integral lead through the primary incision and routing it subcutaneously to a second desired nerve region different than the first desired nerve region along a second desired path;

inserting the tertiary integral lead through the primary incision and routing it subcutaneously to a third desired nerve region different than the first and second desired nerve regions along a third desired path;

disposing the IPG in the pocket through the primary incision;

closing the primary incision; and

activating the IPG and the electrodes to provide localized stimulation to the desired nerve regions and at least one of the nerves associated with each of the desired nerve regions to achieve a desired pain reduction response from the patient.

11. The method of claim 10, wherein the neurostimulator further includes a quaternary integral lead, and further comprises:

inserting the quaternary integral lead through the primary incision and routing it subcutaneously to a fourth desired nerve region different than the first, second, and third desired nerve regions along a fourth desired path.

12. The method of claim 11, wherein the second desired nerve region is diametrically opposite the primary incision from the first desired nerve region.

13. The method of claim 10, wherein the selected portion of the body is the head.

14. The method of claim 13, wherein the incision is disposed proximate to and above the pinna.

15. The method of claim 10, wherein the selected portion of the body includes at least one nerve in the cranium and the primary integral lead is disposed so that at least one of the electrodes thereon is disposed above at least one nerve in the first desired nerve region.

16. The method of claim 15, wherein the at least one nerve is at least one of the body, branches and roots selected from the group consisting of the supraorbital nerves, the auriculo-temporal nerves and the occipital nerves.

17. The method of claim 10, wherein

the step of opening the primary incision includes:

the step of opening a secondary incision along the first desired path and disposed away from the primary incision, and

the step of opening a tertiary incision along the third desired path and disposed away from the primary incision;

wherein the step of inserting the primary integral lead comprises;

inserting the primary integral lead through the primary incision and routing it subcutaneously to the secondary incision along the first desired path and extending through the secondary incision, and

inserting the primary integral lead back through the secondary incision and routing it subcutaneously to the first desired nerve region along the first desired path;

wherein the step of inserting the tertiary lead comprises;

inserting the tertiary integral lead through the primary incision and routing it subcutaneously to the tertiary incision along the third desired path and extending through the tertiary incision, and

inserting the tertiary integral lead back through the tertiary incision and routing it subcutaneously to the third desired nerve region along the third desired path; and

wherein the step of closing the primary incision includes a step of closing the secondary and tertiary incisions.

18. The method of claim 17 wherein the desired pain reduction response is to reduce pain from headaches selected from the group consisting of migraine headaches, tension type headaches, cluster headaches, chronic daily headaches, hemicranias continua headaches, cervicogenic headaches, and secondary musculoskeletal headaches.

19. The method of claim 17, wherein the desired pain reduction response is to reduce pain from the type selected from the group consisting of neuropathic head pain, neuropathic face pain, nociceptive head pain, nociceptive face pain, sympathetic related head pain, and sympathetic related face pain.

20. The method of claim 17, wherein the desired pain reduction response is to reduce pain from neuralgia selected from the group consisting of greater occipital neuralgia, supraorbital neuralgia, auriculo-temporal neuralgia, infraorbital neuralgia, and trigeminal neuralgia.