Percutaneous access for systems and methods of treating sleep apnea

• US 9,486,628 B2
• Filed: 03/30/2010
• Issued: 11/08/2016
• 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): Yabut, Diane
• Assistant Examiner(s): TON, MARTIN TRUYEN
• Application Number:
  US13/262,434
• Publication Number:
  US 20120089153A1
• Time in Patent Office: 2,415 Days
• Field of Search: 606/129
• US Class Current: 1/1
• 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 of implanting a stimulation lead to treat sleep-related disordered breathing, comprising:

percutaneously inserting a distal portion of a cannula and positioning the distal portion to be adjacent to a target nerve stimulation site while maintaining a proximal portion of the cannula external to a skin surface, wherein the target nerve stimulation site includes an airway-patency related nerve;

arranging a stimulation lead to include a distal portion having a first side and a second side opposite the first side, the stimulation lead including;

at least one anchor member positioned on, and biased to extend outwardly from, the second side in a deployment position;

at least one stimulation electrode on the first side;

slidably advancing the distal portion of the stimulation lead into and through the cannula to percutaneously insert the stimulation lead until a distal portion of the stimulation lead is positioned against the nerve at the target stimulation site, wherein slidable advancement of the distal portion of the stimulation lead into the proximal portion of the cannula causes the at least one anchor member to be releasably contained against a body of the second side of the stimulation lead in a storage portion;

arranging at least the distal portion of the cannula to have a generally tubular configuration;

arranging the cannula to include a distal extension, which extends distally from the distal tip of the generally tubular distal portion of the cannula,

wherein, in at least one slidable position of the stimulation lead relative to the cannula, releasably containing the at least one anchor member in the storage position comprises;

releasably covering the at least one anchor member via the distal extension of the cannula while simultaneously exposing the at least one stimulation electrode of the stimulation lead toward the nerve and

slidably removing the cannula, while maintaining the position of the distal portion of the stimulation lead at the target stimulation site, to cause the at least one anchor member to extend outwardly from the second side of the stimulation lead in the deployment position against tissue adjacent the distal portion of the stimulation lead.

2. The method of claim 1, comprising:

arranging the second side of the distal portion of the stimulation lead to include an insulating element opposite the at least one stimulation electrode on the first side to prevent stimulation of tissue adjacent the second side of the distal portion.

3. The method of claim 1, comprising:

arranging the at least one anchor member as an array of protrusions spaced apart along a portion of the length of the second side of the distal portion of the stimulation lead with the respective protrusions being generally opposite the at least one stimulation electrode on the first side.

4. The method of claim 3, comprising:

arranging each respective protrusion as a barb.

5. The method of claim 1, comprising:

arranging the distal portion of the cannula to include a flexible generally curved shape such that in a deployment position, an end of the distal portion cannula is oriented in a direction oriented at a generally obtuse angle relative to a longitudinal axis of a proximal portion of the cannula and in an insertion position, the flexible distal portion is configurable to assume an orientation generally parallel to the longitudinal axis of the proximal portion of the cannula.

6. The method of claim 5, comprising:

upon positioning the distal portion of the stimulation lead at the target stimulation site, causing the flexible distal portion of the cannula to assume the generally curved shape.

7. The method of claim 6, comprising:

locating an entry point of the cannula into the skin surface at a first distance away from the target stimulation site, wherein the first distance is generally equal to a sum of;

a second distance between the end of the cannula and a longitudinal axis of the proximal portion of the cannula when the distal portion is in the deployment position; and

a third distance corresponding to at most a length of an electrode portion of the stimulation lead.

8. The method of claim 6, comprising:

via a percutaneous access, advancing a proximal portion of the stimulation lead from the target stimulation site to a pectoral region of a patient.

9. The method of claim 1, comprising:

arranging the distal portion of the cannula to include a generally rigid, straight portion having an opening oriented generally perpendicular to a longitudinal axis of the cannula;

wherein slidably advancing the stimulation lead into and through the cannula causes the distal portion of the stimulation lead to extend out of the end of the opening of the cannula in an orientation at a generally obtuse angle relative to the proximal portion of the cannula.

10. The method of claim 9, comprising:

locating an entry point of the cannula into the skin surface at a first distance away from the target stimulation site, wherein the first distance is generally equal to a second distance corresponding to at most a length of an electrode portion of the stimulation lead.

11. The method of claim 1, comprising:

upon advancing the cannula, measuring a depth of insertion of the distal portion of the stimulation lead via graduation markings spaced apart along a length of the cannula.

12. The method of claim 1, comprising:

percutaneously inserting a test needle at a plurality of test stimulation sites, including the target stimulation site, wherein the test needle is separate from and independent of the cannula and the test needle is separate from, and independent of, the stimulation lead;

determining the target stimulation site from among the plurality of test stimulation sites via applying, at each respective test stimulation site, a stimulation signal;

monitoring, during application of the stimulation signal, at least one of;

occurrence of a tongue protrusion or tongue retraction;

change in a cross-sectional area of an upper airway;

a lack of response in non-target muscles;

a twitch in a tongue muscle or laryngeal muscle;

or

strongest electromyography response for a target muscle.

13. The method of claim 12, comprising:

identifying, based on the determined target stimulation site, a percutaneous access pathway to the target stimulation site.

14. The method of claim 1, comprising:

evaluating the target nerve stimulation site via varying an array of stimulation parameters, which include at least one of an amplitude parameter, a frequency parameter, a pulse width parameter, a polarity parameter, and a duration parameter.

15. The method of claim 12, comprising:

arranging the test needle to include a distal portion and a proximal portion with the proximal portion including a handle releasably secured relative to the proximal portion, wherein the handle is sized to remain external to a skin surface and the needle has a length configured to percutaneously access a nerve.

16. The method of claim 15, comprising:

arranging the cannula as a generally tubular member having a distal portion, a proximal portion, and configured to be slidably advanceable over the test needle.

17. The method of claim 12, comprising:

arranging at least one of the test needle, the cannula, and the stimulation lead include at least one radiopaque marker configured to identify, under fluoroscopy, an orientation and position of the respective test needle, cannula, or stimulation lead.

18. The method of claim 12, comprising:

arranging an intermediate portion of the test needle to include a series of graduation markings spaced apart along a portion of a length of the test needle and positioned to gauge a depth of insertion of the test needle percutaneously.

19. The method of claim 12, comprising:

providing a response monitor in communication with the test needle and in communication with one or more physiologic sensors; and

using the response monitor to identify a muscle-based physiologic response upon application of a nerve stimulation signal via the test needle.

20. The method of claim 1, wherein the at least one stimulation electrode comprises an array of stimulation electrodes, the array including more than three stimulation electrodes from which an operative set of electrodes is selectable at any given time.

21. The method of claim 3, comprising:

arranging at least some of the respective protrusions to extend in a first direction that diverges from a second direction in which at least some other of the respective protrusions extend.

22. The method of claim 3, comprising:

performing the percutaneous insertion of the stimulation lead, via the cannula, external to a blood vessel.

23. The method of claim 1, comprising:

arranging the at least one anchor member on the second side of the distal portion of the stimulation electrode to be isolated from the nerve against which the at least one stimulation electrode is positioned.

29. The method of claim 1, wherein the at least one stimulation electrode is located only on the first side.

30. The method of claim 29, wherein the at least one anchor member is located only on the second side.

31. The method of claim 2, wherein the at least one stimulation electrode extends only on the first side of the distal portion.

32. The method of claim 31, wherein the insulating element extends the entire length of the second side of the distal portion.

33. The method of claim 3, comprising:

arranging each respective protrusion as a prong.

34. The method of claim 3, comprising:

arranging each respective protrusion as a flap.

35. The method of claim 1, wherein the distal extension comprises a half-circular cross-sectional shape and a distal end at which the cannula terminates, and wherein the cannula defines an opening opposite the distal extension to expose the at least one stimulation electrode.

24. A method of implanting a stimulation lead to treat sleep-related disordered breathing, comprising:

percutaneously inserting a distal portion of a cannula and positioning the distal portion to be adjacent to a first target nerve stimulation site while maintaining a proximal portion of the cannula external to a skin surface, wherein the first target nerve stimulation site includes an airway-patency related nerve;

arranging a stimulation lead to include a distal portion having a first side and a second side opposite the first side, the stimulation lead including;

at least one anchor member positioned on, and biased to extend outwardly from, the second side;

at least one stimulation electrode on the first side;

slidably advancing the distal portion of the stimulation lead into and through the cannula until a distal portion of the stimulation lead is positioned against the nerve at the first target nerve stimulation site, wherein slidable advancement of the distal portion of the stimulation lead into the proximal portion of the cannula causes the at least one anchor member to be releasably contained against a body of the second side of the stimulation lead in a storage portion;

arranging the cannula to include a distal extension, which extends distally from the distal tip of the generally tubular distal portion of the cannula,

wherein, in at least one slidable position of the stimulation lead relative to the cannula, releasably containing the at least one anchor member in the storage position comprises releasably covering the at least one anchor member via the distal extension of the cannula while simultaneously exposing the at least one stimulation electrode of the stimulation lead toward the nerve,

with the stimulation lead in the at least one slidable position, maneuvering a combination of the stimulation lead and the cannula together along the nerve and periodically applying a test stimulation signal to identify the first target nerve stimulation site from among a plurality of test stimulation sites along a length of the nerve; and

slidably removing the cannula, while maintaining the position of the distal portion of the stimulation lead at the first target nerve stimulation site, to permit the at least one anchor member to extend outwardly from the second side of the stimulation lead in a deployment position against tissue adjacent the distal portion of the stimulation lead.

25. The method of claim 24, wherein identifying the first target nerve stimulation site comprises:

varying an array of stimulation parameters at each test stimulation site, the respective stimulation parameters including at least one of an amplitude parameter, a frequency parameter, a pulse width parameter, a polarity parameter, and a duration parameter.

26. The method of claim 25, comprising:

arranging the at least one stimulation electrode to include a patterned array of more than three stimulation electrodes; and

performing the varying the array of stimulation parameters at each respective stimulation electrode to identify a first combination of respective stimulation electrodes for applying nerve stimulation at the first target nerve stimulation site.

27. The method of claim 26, comprising:

selectively re-performing the varying of stimulation parameters at each respective stimulation electrode to identify a different, second combination of respective electrodes for applying nerve stimulation at the first nerve stimulation site, wherein at least some of the respective stimulation electrodes in the first combination are omitted in the second combination.

28. The method of claim 26, comprising:

re-positioning the stimulation lead along the nerve; and

selectively re-performing the varying of stimulation parameters at each respective stimulation electrode to identify a different, second combination of respective electrodes for applying nerve stimulation at a second nerve stimulation site different than the first nerve stimulation site.