Baroreflex activation for sedation and sleep

• US 8,224,437 B2
• Filed: 10/03/2008
• Issued: 07/17/2012
• Est. Priority Date: 10/22/2003
• Status: Active Grant

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Kieval, Robert S., Rossing, Martin A.
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Malamud, Deborah
• Application Number:
  US12/245,636
• Publication Number:
  US 20090030262A1
• Time in Patent Office: 1,383 Days
• Field of Search: 607 1- 3, 607/9, 607/72
• US Class Current: 607/2
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

Systems and methods provide baroreflex activation to treat or reduce pain and/or to cause or enhance sedation or sleep. Methods involve activating the baroreflex system to provide pain reduction, sedation, improved sleep or some combination thereof. Systems include at least one baroreflex activation device, at least one sensor for sensing physiological activity of the patient, and a processor coupled with the baroreflex activation device(s) and the sensor(s) for processing sensed data received from the sensor and for activating the baroreflex activation device. In some embodiments, the system is fully implantable within a patient, such as in an intravascular, extravascular or intramural location.

Claims

1. A method for baroreceptor stimulation via an intra-to-extravascular approach, the method comprising:

intravascularly advancing at least one electrode to a treatment site within vasculature of a patient;

passing a portion of the electrode through at least a portion of a wall of the vasculature to position the electrode at an extravascular location via an intra-to-extravascular approach; and

extravascularly delivering an electric field via the electrode to stimulate a baroreceptor.

2. The method of claim 1, wherein intravascularly advancing at least one electrode to a treatment site within vasculature of a patient further comprises intravascularly moving the electrode to a treatment site within a renal artery of the patient.

3. The method of claim 1, wherein intravascularly advancing at least one electrode to a treatment site within vasculature of a patient further comprises intravascularly moving an intravascular catheter having the electrode to the treatment site within the vasculature of the patient.

4. The method of claim 3, wherein passing a portion of the electrode through at least a portion of a wall of the vasculature to positioning the electrode at an extravascular location via an intra-to-extravascular approach further comprises expanding an expandable element of the catheter.

5. The method of claim 1, wherein intravascularly advancing at least one electrode to a treatment site within vasculature of a patient further comprises moving the electrode through an intravascular catheter positioned at the treatment site.

6. The method of claim 1, wherein passing a portion of the electrode through at least a portion of a wall of the vasculature to position the electrode at an extravascular location via an intra-to-extravascular approach further comprises piercing the wall of the vasculature, and advancing the electrode through the wall piercing.

7. The method of claim 6, wherein piercing the wall of the vasculature further comprises forcing the electrode through the wall of the vasculature.

8. The method of claim 1, wherein advancing at least one electrode to a treatment site further comprises advancing at least one bipolar electrode pair to the treatment site.

9. The method of claim 8, wherein passing a portion of the electrode through at least a portion of a wall of the vasculature to position the electrode at an extravascular location via an intra-to-extravascular approach further comprises moving the bipolar electrode pair extravascularly, and wherein extravascularly delivering an electric field further comprises extravascularly delivering the electric field across the bipolar electrode pair.

10. The method of claim 8, wherein passing a portion of the electrode through at least a portion of a wall of the vasculature to position the electrode at an extravascular location via an intra-to-extravascular approach further comprises positioning a first electrode of the bipolar electrode pair at the extravascular location and positioning a second electrode of the bipolar electrode pair at an intravascular location.

11. The method of claim 1, further comprising infusing an agent to enhance the baroreceptor stimulation.

12. The method of claim 1, wherein extravascularly delivering an electric field via the electrode to stimulate a baroreceptor further comprises extravascularly delivering a pulsed electric field via the electrode to stimulate the baroreceptor.

13. The method of claim 1, wherein extravascularly delivering an electric field via the electrode to stimulate a baroreceptor further comprises extravascularly delivering RF energy via the electrode to stimulate the baroreceptor.

14. The method of claim 1, wherein extravascularly delivering an electric field via the electrode to stimulate a baroreceptor further comprises extravascularly delivering thermal energy via the electrode to stimulate the baroreceptor.

15. The method of claim 1, wherein the extravascular location comprises on the outside of an artery or vein.

16. A method for baroreceptor stimulation via an intra-to-extravascular approach, the method comprising:

intravascularly advancing at least one electrode to a treatment site within vasculature of a patient;

passing a portion of the electrode through at least a portion of a wall of the vasculature to position the electrode at an extravascular location via an intra-to-extravascular approach; and

causing an electric field to be extravascularly delivered via the electrode to stimulate a baroreceptor.

17. A method for baroreceptor stimulation via an intra-to-extravascular approach, the method comprising:

causing a pulse generator to be manufactured and made available to a user;

causing at least one electrode to be manufactured and made available to the user, the electrode electrically coupleable to the pulse generator; and

providing instructions to the user, comprising;

implanting the pulse generator within a patient;

intravascularly advancing the at least one electrode to a treatment site within vasculature of the patient;

passing a portion of the electrode through at least a portion of a wall of the vasculature to position the electrode at an extravascular location via an intra-to-extravascular approach; and

causing an electric field to be extravascularly delivered via the electrode to stimulate a baroreceptor.