System and method for transvascularly stimulating contents of the carotid sheath

• US 8,369,954 B2
• Filed: 03/07/2011
• Issued: 02/05/2013
• Est. Priority Date: 03/27/2008
• Status: Active Grant

• Current Assignee: Nuxcel2 LLC
• Original Assignee: Synecor LLC
• Inventors: Stack, Richard S., Williams, Michael S., Fifer, Daniel W., Glenn, Richard A., Orth, Geoffrey A., Elliott, Lynn, N'diaye, Colleen Stack
• Primary Examiner(s): Manuel, George
• Assistant Examiner(s): Wieland, Robert N
• Application Number:
  US13/042,350
• Publication Number:
  US 20110166482A1
• Time in Patent Office: 701 Days
• Field of Search: 607/44, 607/2, 607/3, 607/62, 607/116, 607/41
• US Class Current: 607/44
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 2007/0043 intra-cavitary

Abstract

Methods and systems are disclosed for stimulating contents of the carotid sheath using an intravascular pulse generator and lead. The lead carries an energy delivery device such as an electrode, which is anchor within the portion of the internal jugular vein that is disposed within the carotid sheath. The energy delivery device is energized to transvenously direct energy to target contents of the carotid sheath external to the internal jugular vein. Such target contents may include nervous system elements associated with the carotid sinus baroreceptors, the carotid sinus nerve and associated nerve branches, and or the vagus nerve and associated nerve branches. The system may be used to control blood pressure and/or to lower heart rate and may be suitable for treatment of hypertension, heart failure, or other conditions.

Claims

1. A method for intravascularly stimulating contents of the carotid sheath, comprising:

intravascularly advancing an energy-delivery element into an internal jugular vein;

retaining the energy delivery element in a portion of the internal jugular vein contained within a carotid sheath; and

energizing the energy delivery implant to transvenously direct energy to target contents of the carotid sheath external to the internal jugular vein, said target contents comprising a first target and a second target, the first target selected from the group of targets consisting of a vagus nerve and a vagus nerve branch, the second target selected from the group of targets consisting of a carotid sinus nerve, a carotid sinus nerve branch, and a carotid artery.

2. The method of claim 1, wherein energy is directed to a carotid artery within the carotid sinus sheath.

3. The method of claim 1 wherein energy is directed to a carotid sinus nerve or nerve branch within the carotid sinus sheath.

4. The method of claim 1 wherein energy is directed to a vagus nerve or nerve branch within the carotid sinus sheath.

5. The method of claim 1 wherein energy is directed to nerve branches emanating from carotid artery baroreceptors.

6. The method of claim 1, further including intravascularly advancing a second energy delivery element into a second internal jugular vein;

retaining the second energy delivery element in a portion of the second internal jugular vein contained within a carotid sheath; and

energizing the second energy delivery element to direct energy to contents of the carotid sheath external to the second internal jugular vein.

7. The method of claim 1 wherein the energy is electrical energy.

8. The method of claim 1 wherein the energy is ultrasound energy.

9. The method of claim 1, further including positioning a shield at least partially surrounding the carotid sheath, wherein the shield blocks conduction of energy beyond the sheath during energization of the energy delivery implant.

10. The method of claim 1, further including delivering an insulative material into extravascular space adjacent to the internal jugular vein, the insulative material defining a channel within the extravascular space, and wherein energizing the energy delivery implant causes energy to conduct along the channel to the target contents.

11. The method of claim 10 wherein the material includes a fat.

12. The method of claim 10 wherein the material includes silicone.

13. An intravascular system for stimulation of contents of a carotid sheath, the system comprising:

a pulse generator positionable within a blood vessel;

a lead coupled to the pulse generator;

an anchor adapted to anchor the lead in a portion of an internal jugular vein disposed in a carotid sheath;

a plurality of electrodes disposed on the lead, the electrodes including a first array and a second array, wherein the first and second arrays are positioned such that when the first array is positioned in the internal jugular vein to direct stimulation energy transvascularly to a vagus nerve in the carotid sheath, the second array is positioned to direct stimulation energy transvascularly towards a carotid artery or carotid sinus nerve within the carotid sheath.

14. The system of claim 13, wherein the first and second arrays are independently energizable by the pulse generator.

15. The system of claim 13 wherein the first and second arrays are simultaneously energizable by the pulse generator.