Method and apparatus for stimulation

Patent metadata

Field	Value
Publication number	US-11400293-B2
Application number	US-202016811954-A
Country	US
Kind code	B2
Filing date	Mar 6, 2020
Priority date	Mar 6, 2019
Publication date	Aug 2, 2022
Grant date	Aug 2, 2022

Abstract

A medical device system and method are disclosed for treating obstructive sleep apnea. The system includes a pulse generator and a medical electrical lead including multiple electrodes carried by a distal portion of an elongated lead body. The method includes advancing the distal portion within protrusor muscle tissue below the oral cavity and delivering electrical stimulation pulses via the electrodes to sustain a protruded state throughout a delivery time period to sustain a protruded state of a patient's tongue throughout the therapy delivery time period. The therapy delivery time period may span multiple respiration cycles.

First claim

What is claimed is:

1. A method, comprising:
advancing a hollow delivery tool percutaneously into protrusor muscle tissue below an oral cavity of a patient without penetrating into the oral cavity;
advancing a first distal portion of a first elongated lead body of a first medical electrical lead percutaneously into the protrusor muscle tissue below the oral cavity via the delivery tool without penetrating into the oral cavity to position a first plurality of electrodes carried by the first distal portion within the protrusor muscle tissue, wherein the first plurality of electrodes are configured to be implanted proximate, and without attaching, to a nerve of the protrusor muscle tissue and proximate to a motor point of at least one protrusor muscle of the protrusor muscle tissue; and
delivering electrical stimulation pulses via the first plurality of electrodes to activate the protrusor muscle tissue to sustain a protruded state of a tongue of a patient throughout a therapy delivery time period that comprises a plurality of respiration cycles, wherein delivering the electrical stimulation pulses comprises delivering the electrical stimulation pulses to the motor point of the at least one protrusor muscle of the protrusor muscle tissue.

2. The method of claim 1 , further comprising sequentially selecting a plurality of different bipolar electrode pairs from the first plurality of electrodes during the therapy delivery time period.

3. The method of claim 2 , further comprising:
advancing the first distal portion across a medial plane of the protrusor muscle tissue to position at least a first bipolar electrode pair of the first plurality of electrodes for stimulating a left portion of the protrusor muscle tissue and at least a second bipolar pair of the first plurality of electrodes for stimulating a right portion of the protrusor muscle tissue;
sequentially selecting the first and second bipolar electrode for sequentially activating a left protrusor muscle and a right protrusor muscle for sustaining the protruded state of the tongue throughout the therapy delivery time period.

4. The method of claim 3 , wherein advancing the first distal portion across the medial plane comprises advancing the first distal portion obliquely across the medial plane.

5. The method of claim 1 , further comprising:
advancing the first distal portion along a medial plane of the protrusor muscle to position at least a first bipolar electrode pair of the first plurality of electrodes for stimulating a posterior portion of the protrusor muscle tissue and at least a second bipolar pair of the first plurality of electrodes for stimulating an anterior portion of the protrusor muscle tissue;
sequentially selecting the first and second bipolar electrode pairs to activate muscle tissue of an anterior portion of protrusor muscles of the tongue and a second pair of the plurality of electrodes different than the first pair for activating muscle tissue of a posterior portion of protrusor muscles of the tongue.

6. The method of claim 1 , wherein delivering the electrical stimulation pulses comprises continuously delivering the electrical stimulation pulses from a starting time of the therapy delivery time period to an ending time of the therapy delivery time period by:
selecting a first bipolar pair from the first plurality of electrodes;
delivering a first portion of the electrical stimulation pulses via the first bipolar electrode pair for a first duty cycle of the therapy delivery time period;
selecting a second bipolar pair from the first plurality of electrodes;
delivering a second portion of the electrical stimulation pulses via the second bipolar electrode pair for a second duty cycle of the therapy delivery time period.

7. The method of claim 6 , further comprising delivering the first portion of the electrical stimulation pulses for the first duty cycle and delivering the second portion of the electrical stimulation pulses the second duty cycle independent of inspiratory and expiratory phases of the plurality of respiration cycles.

8. The method of claim 1 , further comprising:
sensing a sensor signal that is correlated to a protrusor muscle tone during the therapy delivery time period;
determining a state of the protrusor muscle tone based on the sensor signal; and
adjusting the electrical stimulation pulses during the therapy delivery time period based on the determined state of the protrusor muscle tone.

9. The method of claim 1 , further comprising advancing the hollow delivery tool percutaneously at a submandibular insertion site and further into the protrusor muscle tissue.

10. The method of claim 1 , wherein advancing the hollow delivery tool comprises advancing the hollow delivery tool percutaneously from a submandibular insertion site and along a posterior to anterior pathway into the protrusor muscle tissue; and
advancing the first distal portion along the posterior to anterior pathway into the protrusor muscle tissue.

11. The method of claim 1 , further comprising:
advancing the first distal portion into the protrusor muscle tissue laterally adjacent to a medial plane of the protrusor muscle tissue to position the first plurality of electrodes along a first side of the protrusor muscle tissue;
advancing a second distal portion of a second medical electrical lead percutaneously into the protrusor muscle tissue below the oral cavity and laterally adjacent to the medial plane of the protrusor muscle tissue on a second side opposite the first side of the protrusor muscle tissue to position a second plurality of electrodes carried by the second distal portion along the second side of the protrusor muscle tissue; and
delivering the electrical stimulation pulses via the first plurality of electrodes and the second plurality of electrodes to activate the protrusor muscle tissue to sustain the protruded state of the patient tongue throughout the therapy delivery time period.

12. The method of claim 11 , further comprising delivering the electrical stimulation pulses by sequentially selecting from the first plurality of electrodes and the second plurality of electrodes at least a first bipolar electrode pair for a first duty cycle and a second bipolar electrode pair for a second duty cycle to sustain the protruded state of the patient's tongue throughout the therapy delivery time period.

13. The method of claim 12 , further comprising one of:
selecting the first bipolar pair from only the first plurality of electrodes and selecting the second bipolar pair from only the second plurality of electrodes; or
selecting the first bipolar pair by selecting at least one of the first plurality of electrodes paired with at least one of the second plurality of electrodes.

14. The method of claim 1 , further comprising:
tunneling a proximal end of the first medical electrical lead to a subcutaneous pocket along a neck of the patient;
coupling the proximal end to a pulse generator implanted in the subcutaneous pocket along the neck; and
generating the electrical stimulation pulses by the pulse generator.

15. A medical device system, comprising:
a first medical electrical lead comprising:
a first elongated lead body extending from a first proximal end to a first distal end with a first distal portion proximate the first distal end, the first distal portion configured for percutaneous advancement via a hollow delivery tool within protrusor muscle tissue below an oral cavity without penetrating into the oral cavity;
a first plurality of electrodes spaced apart along the first distal portion for implantation within the protrusor muscl

Assignees

• Medtronic Inc

Inventors

• Scheiner Avram

Classifications

• A61B2562/0219

  Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches · CPC title

• G16H40/63

  for local operation · CPC title

• A61N1/3601

  of respiratory organs · CPC title

• A61B5/4836

  Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence) · CPC title

• A61N1/36

  for stimulation · CPC title