Percutaneous access for systems and methods of treating sleep-related disordered breathing

• US 10,543,366 B2
• Filed: 11/07/2016
• Issued: 01/28/2020
• Est. Priority Date: 03/31/2009
• Status: Active Grant

• Current Assignee: Inspire Medical Systems, Inc.
• Original Assignee: Inspire Medical Systems, Inc.
• Inventors: Christopherson, Mark A., Ni, Quan, Rondoni, John
• Primary Examiner(s): Ton, Martin T
• Application Number:
  US15/345,096
• Publication Number:
  US 20170151432A1
• Time in Patent Office: 1,177 Days
• Field of Search: 606129
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 5/0826 Detecting or evaluating apnoea events A61B5/4818 takes precedence
• CPC Class Codes: A61B 5/085 Measuring impedance of respiratory organs or lung elasticity
• CPC Class Codes: A61B 5/296 for electromyography [EMG]
• CPC Class Codes: A61B 5/4818 Sleep apnoea
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0553 Paddle shaped electrodes, e.g. for laminotomy
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/3601 of respiratory organs
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula

Abstract

Systems and methods are described and illustrated for percutaneously implanting a stimulation lead for treating sleep-related disordered breathing.

Claims

1. A method comprising:

positioning a stimulation electrode portion within a head-and-neck portion to establish engagement of an electrode array of the stimulation electrode portion against a target portion of an upper-airway-patency-related nerve;

securing the stimulation electrode portion, via a non-nerve securing structure, to non-nerve surrounding tissue to maintain the engagement of the electrode array relative to the target portion;

delaying deployment of an anchor mechanism including the non-nerve securing structure, during the positioning of the electrode array, via covering the anchoring mechanism on a second portion of the stimulation electrode portion via an introduction tool while also exposing the electrode array on a first portion of the stimulation electrode portion to the target portion of the upper-airway-patency-related nerve; and

upon conclusion of the positioning of the electrode array at an identified target stimulation site, engaging non-nerve surrounding tissue via deployment of the anchor mechanism by withdrawing the introduction tool to cause the anchor mechanism to implement the securing of the stimulation electrode portion relative to the non-nerve surrounding tissue.

2. The method of claim 1, comprising:

prior to the positioning, percutaneously inserting the stimulation electrode portion in the head-and-neck region adjacent the airway-patency-related nerve.

3. The method of claim 2, wherein percutaneously implanting the stimulation electrode portion comprises:

making an incision in skin to access the upper-airway-patency-related nerve; and

inserting and advancing the stimulation electrode portion through the incision and underlying tissue until the stimulation electrode portion is positioned against the target portion of the airway-patency-related nerve.

4. The method of claim 3, comprising:

employing the introduction tool to carry the stimulation electrode portion, including the non-nerve securing structure, during the inserting and advancing.

5. The method of claim 1, comprising:

arranging a width of the electrode array to be at least equal to a diameter of the nerve.

6. The method of claim 5, wherein the electrode array comprises at least some electrodes spaced apart along a length of the stimulation electrode portion.

7. The method of claim 5, wherein the electrode array comprises at least some electrodes spaced apart along a width of the stimulation electrode portion.

8. The method of claim 1, comprising:

arranging a carrier body of the stimulation electrode portion as including the first portion with the electrode array and as including the second portion with a non-conductive portion including the non-nerve securing structure of the anchor mechanism on at least one of;

at least one of opposite side portions of the carrier body; and

at least one of opposite end portions of the carrier body; and

maintaining engagement of the electrode array relative to the target portion via securing a respective one of the opposite side portions and end portions to the non-nerve surrounding tissue.

9. The method of claim 8, arranging the non-nerve securing structure as a loop to which at least one anchor element may be coupled;

and

engaging the non-nerve surrounding tissue via the at least one anchor element to secure the loop to the non-nerve surrounding tissue.

10. The method of claim 1, comprising:

arranging the stimulation electrode body as a flexible member to conform to an arcuate shape of the nerve.

11. The method of claim 1, comprising:

arranging the first portion as a front side of the stimulation electrode portion and the second portion as an opposite back side of the stimulation electrode portion, the second portion including the non-nerve securing structure of the anchor mechanism.

12. A method comprising:

selectively initially positioning an electrode array of a stimulation electrode portion along a length of a target portion of an upper-airway-patency-related nerve, while stimulating the nerve, to identify a target stimulation site;

upon final positioning at an identified target stimulation site, utilizing an anchor mechanism including a non-nerve securing structure to secure the stimulation electrode portion to non-nerve surrounding tissue to maintain the engagement of the electrode array relative to the target stimulation site;

during the initial positioning of the electrode array, delaying utilization of the anchor mechanism via covering the anchoring mechanism on a second portion of the stimulation electrode portion via an introduction tool while also exposing the electrode array on a first portion of the stimulation electrode portion to the target portion of the upper-airway-patency-related nerve; and

upon the final positioning of the electrode array at the identified target stimulation site, withdrawing the introduction tool to enable utilization of the non-nerve securing structure of the anchor mechanism to implement the securing of the stimulation electrode portion relative to the non-nerve surrounding tissue.

13. The method of claim 12, comprising:

prior to the selective initial positioning, making an incision in skin and inserting the stimulation electrode portion within a head-and-neck portion to locate the electrode array of the stimulation electrode portion adjacent the identified target stimulation site portion of the upper-airway-patency-related nerve.

14. The method of claim 12, comprising:

arranging a first portion of the anchor mechanism on the second portion of the stimulation electrode portion as at least one of;

at least one opposite side portion; and

at least one opposite end portion of the stimulation electrode portion.

15. The method of claim 14, comprising:

arranging a second portion of the anchor mechanism as a plurality of anchor elements coupled to the respective side portions and end portions of the stimulation electrode portion.

16. The method of claim 15, wherein the delaying the utilization of the anchor mechanism comprises carrying at least the second portion of the anchor mechanism on a distal portion of an implantation instrument;

and

wherein the utilization of the anchor mechanism includes driving, via the implantation instrument, the plurality of anchor elements into the non-nerve surrounding tissue.

17. The method of claim 15, wherein the first portion of the anchor mechanism comprises a loop and each anchor element of the second portion of the anchor mechanism comprises at least a suture.

18. The method of claim 12, comprising:

arranging the stimulation electrode portion as a flexible member to conform to an arcuate shape of the nerve.

19. The method of claim 12, comprising:

arranging a width of the electrode array to be at least equal to a diameter of the nerve.

20. A method comprising:

arranging an electrode array on a front face of a stimulation electrode portion and arranging an opposite back face of the stimulation electrode portion to include a selectively deployable anchor mechanism;

selectively initially positioning the electrode array of the stimulation electrode portion along a length of a target portion of an upper-airway-patency-related nerve, while stimulating the nerve, to identify a target stimulation site;

delaying deployment of the anchor mechanism, during the initial positioning of the electrode array, via covering the anchoring mechanism on the opposite back face of the stimulation electrode portion via an introduction tool while also exposing the electrode array on the front face of the stimulation electrode portion to the target portion of the upper-airway-patency-related nerve; and

upon final positioning of the electrode array at an identified target stimulation site, engaging non-nerve surrounding tissue via deployment of the anchor mechanism by withdrawing the introduction tool to cause the anchor mechanism to secure the stimulation electrode portion relative to the non-nerve surrounding tissue to maintain the engagement of the electrode array relative to the target stimulation site.

21. The method of claim 20, comprising:

prior to the selective initial positioning, making an incision in skin and inserting the stimulation electrode portion within a head-and-neck portion to locate the electrode array of the stimulation electrode portion adjacent the identified target stimulation site portion of the upper-airway-patency-related nerve.