Systems and methods for stimulation of vagus nerve

• US 8,903,509 B2
• Filed: 03/06/2013
• Issued: 12/02/2014
• Est. Priority Date: 03/21/2012
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Tockman, Bruce A., Soltis, Brian D., Liu, Lili, Hammill, Eric F.
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US13/786,856
• Publication Number:
  US 20130253624A1
• Time in Patent Office: 636 Days
• Field of Search: None
• US Class Current: 607/118
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36053 adapted for vagal stimulation A61N1/36114 takes precedence

Abstract

Described is a system for stimulating a target region of a vagus nerve from a location within an internal jugular vein. The system comprises a medical lead and an insulating element. The insulating element is formed from a flexible sheet of electrically insulative material, and is to be implanted within the internal jugular vein to insulate nerve structures proximate the vagus nerve from stimulation. The insulating sheath includes at least one window through which the electrical stimuli can be delivered to the target region of the vagus nerve.

Claims

1. A system for stimulating a target region of a vagus nerve from a location within an internal jugular vein, the system comprising:

a medical lead comprising a lead body extending from a proximal end to a distal end, a conductor extending within the lead body from the proximal end in a direction towards the distal end, and at least one electrode located on the lead body and operatively coupled to the conductor, the electrode configured to transvascularly deliver an electrical stimuli to the target region of the vagus nerve from a location within the internal jugular vein; and

an insulating element including an insulating sheath formed from a flexible sheet of electrically insulative material, wherein the insulating sheath is configured to be implanted within the internal jugular vein and disposed about the lead and to insulate nerve structures proximate the vagus nerve from stimulation, wherein the insulating element further comprises a stent-like fixation member configured to expand from a collapsed delivery configuration to an expanded configuration, wherein in the expanded configuration, the stent-like fixation member is configured to secure the insulating sheath to an inner wail of the internal jugular vein, and wherein the insulating sheath includes at least one window configured to be located between the lead and the target region of the vagus nerve through. which the electrical stimuli can be delivered to the target region of the vagus nerve.

2. The system of claim 1, wherein the stent-like fixation member is balloon expandable.

3. The system of claim 1, wherein the stent-like fixation member is self-expandable.

4. The system of claim 1, wherein the insulating sheath is radially disposed about the stent-like fixation member.

5. The system of claim 1, wherein the stent-like fixation member is radially disposed about the insulating sheath and the insulating sheath is attached to the stent-like fixation member.

6. The system of claim 1, wherein the window comprises a plurality of perforations.

7. The system of claim 1, wherein the window includes an electrically permeable material.

8. A system for stimulating a target region of a vagus nerve from a location within an internal jugular vein in a carotid sheath, the system comprising:

a medical lead comprising a lead body extending from a proximal end to a distal end, a conductor extending within the lead body from the proximal end in a direction towards the distal end, and at least one electrode located on the lead body and operatively coupled to the conductor, the electrode configured to transvascularly deliver an electrical stimuli to the target region of the vagus nerve from a location within the internal jugular vein; and

an insulating element including an insulating sheath formed from a flexible sheet of electrically insulative material configured to assume a generally tubular shape to surround at least a portion of the carotid sheath when implanted, and configured. to surround the portion of the carotid sheath within which the lead electrode is positioned when implanted in order to insulate nerve structures proximate the vagus nerve from stimulation when the electrical stimuli is delivered by the lead electrode to the target region of the vagus nerve, wherein the insulating sheath comprises a first portion and a second portion, the first portion configured to surround the carotid sheath and the second portion configured to surround and contact an outer surface of the internal jugular vein in order to radially compress a localized region of the internal jugular vein.

9. The system of claim 8, wherein the lead body comprises a pre-formed region configured to engage an inner wall of the internal jugular vein to secure and stabilize the lead body at a desired position within the internal jugular vein.

10. The system of claim 8, wherein the lead body comprises a pre-formed region configured to engage an inner wall of the localized region of the internal jugular vein to secure and stabilize the lead at a desired position within the internal jugular vein.

11. A method for stimulating a target region of a vagus nerve from a location within an internal jugular vein, the method comprising:

deploying an insulating element at a location proximate the target region of the vagus nerve, wherein the insulating element is at least partially radiopaque, wherein the insulating element includes a first portion and a second portion, and wherein deploying the insulating element includes positioning the first portion about the carotid sheath at a location within which the target region of the vagus nerve is located, and positioning the second portion about an outer surface of the internal jugular vein within the carotid sheath;

after deploying the insulating element, advancing a medical lead including at least one electrode within the internal jugular vein while visualizing the deployed insulating element under fluoroscopy to determine a desired implantation position of the medical lead;

positioning the medical lead with the at least one electrode positioned within the internal jugular vein at a location such that the at least one electrode is encircled by the insulating element; and

operatively coupling the medical lead to a pulse generator to supply an electrical stimuli to the vagus nerve via the at least one electrode,

wherein the insulating element operates to electrically insulate nerves proximate the vagus nerve from exposure to the electrical stimuli.

12. The method of claim 11, wherein deploying the insulating element includes advancing the insulating element in a collapsed configuration within a delivery catheter to a location within the internal jugular vein proximate the target region of the vagus nerve, and releasing the insulating element from the delivery catheter thereby causing or allowing the insulating element to assume an expanded configuration in which the insulating element is secured against an inner wall of the internal jugular vein.

13. The method of claim 12, wherein deploying the insulating element further includes orienting an electrically permeable window on the insulating element toward the vagus nerve, and wherein positioning the medical lead includes positioning the at least one electrode such that the electrical stimuli can be directed toward the vagus nerve through the window.

14. The method of claim 12, wherein the insulating element includes an insulating sheath and a stent-like fixation member configured to transition from the collapsed configuration for delivery to the expanded configuration to secure the insulating element against the inner wall of the internal jugular vein.

15. The method according to claim 11, further comprising securing the lead to the insulating element such that the electrode of the medical lead is adjacent the target region of the vagus nerve.

16. The method according to claim 11, wherein deploying the insulating element includes positioning at least a portion of the insulating element about the carotid sheath at a location within which the target region of the vagus nerve is located.

17. The method of claim 11, wherein the second portion of the insulating element is shaped to radially compress a region of the internal jugular vein, and wherein the lead body includes a pre-formed region defining a free dimension greater than a diameter of the compressed region of the internal jugular vein, and wherein positioning the medical lead includes positioning the pre-formed region so as to contact the compressed region of the internal jugular vein to inhibit longitudinal movement of the medical lead within the internal jugular vein.