Apparatus, system, and method for selective stimulation

• US 9,849,288 B2
• Filed: 02/25/2013
• Issued: 12/26/2017
• Est. Priority Date: 10/09/2007
• Status: Active Grant

• Current Assignee: ImThera Medical, Inc. (LivaNova Plc)
• Original Assignee: ImThera Medical, Inc. (LivaNova Plc)
• Inventors: Meadows, Paul M., Lima, Marcelo G., Craig, Stanley R.
• Primary Examiner(s): Bertram, Eric D.
• Application Number:
  US13/775,349
• Publication Number:
  US 20130165996A1
• Time in Patent Office: 1,765 Days
• Field of Search: 607 36, 607 42, 607118
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/3605 Implantable neurostimulators for stimulating central or peripheral nerve system
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/3611 Respiration control stimulating respiratory organs A61N1/3601
• CPC Class Codes: A61N 1/36135 using physiological parameters
• CPC Class Codes: A61N 1/37217 characterised by the communication link, e.g. acoustic or tactile
• 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 1/378 Electrical supply
• CPC Class Codes: A61N 1/3787 from an external energy source

Abstract

An implantable neurostimulator system is disclosed, the neurostimulator system comprising a hollow cylindrical electronics enclosure having a top, a bottom, and a side; a coil extending from a first part of the electronics enclosure; and at least one electrode operatively connected to the electronics enclosure.

Claims

1. A method of treating sleep apnea using neurostimulation to control the position of a patient'"'"'s tongue, comprising the steps of:

implanting an electrode having a plurality of contacts into the patient to electrically couple the plurality of contacts to a Hypoglossal nerve of the patient;

implanting an implantable pulse generator (IPG) into the sub-mandibular space of the patient, the IPG being electronically coupled to the electrode, the IPG comprising a symmetrical, chevron-shaped molded body having an apex at a distal end of the IPG, a coil at the apex of the chevron-shaped molded body, and an electronics enclosure at least partially integral with the chevron-shaped molded body and proximal to the coil, a first lead extending from the electronics enclosure and along a first leg of the chevron-shaped molded body, and a second lead extending from the electronics enclosure and along a second leg of the chevron-shaped molded body, the first leg extending proximally and laterally from a first side of the electronics enclosure, and the second leg extending proximally and laterally from a second side of the electronics enclosure opposite the first side of the electronics enclosure; and

programming the IPG to deliver at least two electric signals to the plurality of contacts during a therapy session without taking into account a timing of respiration.

2. The method of claim 1 further comprising the step of:

defining a neural activation volume by applying the at least two electric signals.

3. The method of claim 2, wherein the at least two electric signals are applied approximately simultaneously.

4. The method of claim 2, wherein at least one of the at least two electric signals is an asymmetric pulse.

5. The method of claim 1, wherein each of the at least two electric signals is a pulse train having a frequency between approximately 1 and approximately 100 Hertz.

6. The method of claim 1, wherein the electrode includes a cuff housing and wherein implanting the electrode includes wrapping the cuff housing around a portion of the Hypoglossal nerve.

7. The method of claim 6, wherein implanting the electrode includes wrapping the cuff housing around the portion of the Hypoglossal nerve at least once.

8. The method of claim 1, wherein the at least two electric signals are applied to the Hypoglossal nerve via an open loop system.

9. The method of claim 1, wherein the at least two electric signals are applied to a portion of the Hypoglossal nerve to stimulate at least two muscles of the tongue such that the stimulation of one of the at least two muscles of the tongue partially overlaps with the stimulation of another of the at least two muscles of the tongue.

10. The method of claim 1, wherein implanting an electrode having a plurality of contacts includes implanting a first electrode having at least one contact and implanting a second electrode having at least one contact.

11. The method of claim 1, further comprising the step of:

applying the at least two electric signals via the plurality of contacts to a portion of the Hypoglossal nerve to stimulate at least two muscles of the tongue to prevent the tongue from blocking an airway during the therapy session,

wherein applying the at least two electric signals includes driving each of the plurality of contacts by their own independent current source.

12. The method of claim 1, wherein the IPG further comprises:

one or more holes extending through the chevron-shaped molded body along each side of the apex, each of the one or more holes having a complete perimeter defined by the IPG.

13. The method of claim 1, wherein the IPG is configured to be able to stimulate a left side Hypoglossal nerve, a right side Hypoglossal nerve, or both the left side and the right side Hypoglossal nerve, regardless of an orientation of the IPG as implanted.

14. The method of claim 1, wherein the IPG includes a first electrode lead coupled to the first lead and extending from the first leg of the chevron-shaped molded body, and a second electrode lead coupled to the second lead and extending from the second leg of the chevron-shaped molded body.

15. The method of claim 1, wherein closely tracing the entire outer perimeter of the chevron-shaped molded body of the IPG results in a chevron shape with smooth corners.

16. The method of claim 1, wherein implanting the IPG into the sub-manibular space of the patient includes selecting the IPG to be implanted independent of whether the electrode is implanted on the right and/or left side of the patient.

17. The method of claim 1, wherein the electrode is a first electrode having at least one first contact electrically coupled to a first Hypoglossal nerve of the patient, the method further comprising the steps of:

implanting a second electrode having at least one second contact into a patient to electrically couple the at least one second contact to a second Hypoglossal nerve of the patient; and

applying at least one of the at least two electric signals via the at least one first contact and at least one of the at least two electric signals via the at least one second contact to the first and second Hypoglossal nerves respectively to stimulate a portion of the first Hypoglossal nerve and a portion of the second Hypoglossal nerve to treat sleep apnea by preventing the tongue from blocking an airway during the therapy session.

18. The method of claim 1, wherein the first lead extends from the first side of the electronics enclosure and the second lead extends from the second side of the electronics enclosure.