IP Library Granted Patent US 11,400,302
Granted Patent B2
US 11,400,302 · App. 17/085,434 · Granted Aug 2, 2022

Surgical method for implantable neurostimulation system for pain

Inventors: Kenneth Lyle Reed (Dallas, TX); Robert Raymond Bulger (Dallas, TX); Michael Steven Colvin (Newbury Park, CA); Claire Denault (Dallas, TX)
Assignee: Shiratronics, Inc.
A61N1/3787A61N1/0504A61N1/0526A61N1/0551A61N1/36075A61N1/375A61N1/37211A61N1/0529A61N1/37229A61N1/37247
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Quick Facts
Patent No.
US 11,400,302
App. No.
17/085,434
Granted
Aug 2, 2022
Kind
B2
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 (56)

1. A method for treating pain in a patient, comprising:

implanting an IPG of a first neurostimulator on a first side of a head of a patient, including:

opening a first primary incision on the first side of the head to expose the subcutaneous region below the dermis in the patient;

opening a first pocket through the first primary incision;

inserting a lead for the first neurostimulator through the first primary incision and passing subcutaneously a distal portion of the lead from the first pocket to a nerve region on the first side of head to subcutaneously position electrodes on the lead proximate to the nerve region on the first side of the head;

disposing a body of the IPG of the first neurostimulator in the first pocket through the first primary incision; and

closing the first primary incision; and

implanting an IPG of a second neurostimulator on a second side of the head of the patient, including:

opening a second primary incision on the second side of the head to expose the subcutaneous region below the dermis in the patient;

opening a second pocket through the second primary incision;

inserting a lead for the second neurostimulator through the second primary incision and passing subcutaneously a distal portion of the lead from the second pocket to a nerve region on the second side of the head to subcutaneously position electrodes on the lead proximate to the nerve region on the second side of the head;

disposing a body of the IPG of the second neurostimulator in the pocket through the second primary incision; and

closing the second primary incision; and

providing a pain therapy by locally stimulating the first nerve region on the first side of the head using the first neurostimulator and locally stimulating the second nerve region on the second side of the head using the second neurostimulator.

2. The method of claim 1 , further comprising placing a headset on the head, including concurrently positioning a first headset coil proximate to the IPG of the first neurostimulator and a second headset coil proximate to the IPG of the second neurostimulator.

3. The method of claim 2 , wherein the IPG for each of the first and second neurostimulators includes a rechargeable battery, the method including recharging the rechargeable battery of the first neurostimulator using the first headset coil and recharging the rechargeable battery of the second neurostimulator using the second headset coil.

4. The method of claim 2 , further comprising communicating with the first neurostimulator using the first headset coil and communicating the second neurostimulator using the second headset coil.

5. The method of claim 4 , further comprising using a handheld device to communicate with the first neurostimulator using the first headset coil and the second neurostimulator using the second headset coil.

6. The method of claim 4 , further comprising using Bluetooth communication to communicate with an external device.

7. The method of claim 2 , further comprising using an external device to interface with the first neurostimulator and with the second neurostimulator, including performing RF communication using the external device.

8. The method of claim 7 , wherein the RF communication includes Bluetooth or Zigbee communication.

9. The method of claim 2 , wherein the IPG for each of the first and second neurostimulators includes a rechargeable battery, the method including:

recharging the rechargeable battery of the first neurostimulator using the first headset coil and recharging the rechargeable battery of the second neurostimulator using the second headset coil; and

communicating with the first neurostimulator using the first headset coil and communicating the second neurostimulator using the second headset coil.

10. The method of claim 1 , wherein the nerve region on the first side of the head and the nerve region on the second side of the head includes occipital nerves.

11. The method of claim 1 , wherein the nerve region on the first side of the head and the nerve region on the second side of the head includes supraorbital nerves.

12. The method of claim 1 , wherein the nerve region on the first side of the head and the nerve region on the second side of the head includes auricular-temporal nerves.

13. The method of claim 1 , wherein the first primary incision on the first side of the head is disposed proximate to and above a pinna on the first side of the head, and the second primary incision on the second side of the head is disposed proximate to and above a pinna on the second side of the head.

14. The method of claim 1 , wherein the pain therapy includes a therapy to treat migraine headaches.

15. The method of claim 1 , wherein the pain therapy includes a therapy to treat headaches selected from the group consisting of tension type headaches, cluster headaches, chronic daily headaches, hemicranias continua headaches, cervicogenic headaches, and secondary musculoskeletal headaches.

16. The method of claim 1 , wherein the pain therapy includes a therapy to treat pain 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.

17. The method of claim 1 , wherein the pain therapy includes a therapy to treat pain from neuralgia selected from the group consisting of greater occipital neuralgia, supraorbital neuralgia, auriculotemporal neuralgia, infraorbital neuralgia, and trigeminal neuralgia.

18. A method for treating bilateral pain in a patient, comprising:

implanting an IPG of a first neurostimulator on a first side of a head of a patient, including:

opening a first primary incision on the first side of the head to expose the subcutaneous region below the dermis in the patient;

opening a first pocket through the first primary incision;

inserting a first lead for the first neurostimulator through the first primary incision and passing subcutaneously a distal portion of the first lead from the first pocket to a first nerve region for the first side of the head to subcutaneously position electrodes on the first lead proximate to the first nerve region for the first side of the head;

inserting a second lead for the first neurostimulator through the first primary incision and passing subcutaneously a distal portion of the second lead from the first pocket to a second nerve region to subcutaneously position electrodes on the second lead proximate to the second nerve region for the first side of the head;

disposing a body of the IPG of the first neurostimulator in the first pocket through the first primary incision; and

closing the first primary incision; and

implanting an IPG of a second neurostimulator on a second side of the head of the patient, including:

opening a second primary incision on the second side of the head to expose the subcutaneous region below the dermis in the patient;

opening a second pocket through the second primary incision;

inserting a first lead for the second neurostimulator through the second primary incision and passing subcutaneously a distal portion of the first lead from the second pocket to a first nerve region for the first side of the head to subcutaneously position electrodes on the first lead proximate to the first nerve region for the second side of the head;

inserting a second lead for the second neurostimulator through the second primary incision and passing subcutaneously a distal portion of the second lead from the second pocket to a second nerve region on the second side of the head to subcutaneously position electrodes on the second lead proximate to the second nerve region for the second side of the head;

disposing a body of the IPG of the second neurostimulator in the pocket through the second primary incision; and

closing the secondary primary incision; and

providing a bilateral pain therapy by locally stimulating the first and second nerve regions on the first side of the head using the first neurostimulator and locally stimulating the first and second nerve regions on the second side of the head using the second neurostimulator.

19. The method of claim 18 , further comprising placing a headset on the head, including concurrently positioning a first headset coil proximate to the IPG of the first neurostimulator and a second headset coil proximate to the IPG of the second neurostimulator.

20. The method of claim 19 , further comprising using an external device to interface with the first neurostimulator and with the second neurostimulator, including performing RF communication using the external device.

21. The method of claim 20 , wherein the RF communication includes Bluetooth or Zigbee communication.

22. The method of claim 19 , wherein the IPG for each of the first and second neurostimulators includes a rechargeable battery, the method including recharging the rechargeable battery of the first neurostimulator using the first headset coil and recharging the rechargeable battery of the second neurostimulator using the second headset coil.

23. The method of claim 19 , further comprising communicating with the first neurostimulator using the first headset coil and communicating the second neurostimulator using the second headset coil.

24. The method of claim 23 , further comprising using a handheld device to communicate with the first neurostimulator using the first headset coil and the second neurostimulator using the second headset coil.

25. The method of claim 24 , wherein the using the handheld device to communicate includes using RF communication between the handheld device and the headset.

26. The method of claim 18 , wherein the bilateral pain therapy includes a therapy to treat headaches.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 4, 2021
From: NUXCEL, INC.
To: SHIRATRONICS, INC.
Reel/Frame 057689/0666 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 30, 2020
From: BULGER, ROBERT RAYMOND; COLVIN, MICHAEL STEVEN; DENAULT, CLAIRE; REED, KENNETH LYLE
To: SYNTILLA MEDICAL, LLC
Reel/Frame 054225/0972 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 30, 2020
From: SYNTILLA MEDICAL, LLC
To: NUXCEL, INC.
Reel/Frame 054226/0083 →
Continuity (6)
Continuation 15890020 · Feb 6, 2018
Division 14879943 · Oct 9, 2015
Continuation In Part 14717912 · May 20, 2015
Continuation 14460139 · Aug 14, 2014
Provisional Application 61894795 · Oct 23, 2013
Related Publication 20210046319A1 · Feb 18, 2021
Cited By (1)
US 12,569,683