Expandable Stimulation Electrode with Integrated Pressure Sensor and Methods Related Thereto

• US 20080177350A1
• Filed: 10/31/2007
• Published: 07/24/2008
• Est. Priority Date: 09/27/2000
• Status: Abandoned Application

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Crossing, Martin, Kieval, Robert S.
• Application Number:
  US11/933,252
• Publication Number:
  US 20080177350A1
• Time in Patent Office: Days
• US Class Current: 607/44
• 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

Abstract

An apparatus is provided having at least one fixation electrode adapted to abut a wall of a pulmonary artery, and a pressure sensor integrally supported by the at least one fixation electrode. The pressure sensor provides a signal indicative of a blood pressure in the pulmonary artery. The apparatus also includes a pulse generator coupled with the at least one fixation electrode, the pulse generator adapted to deliver a baroreflex stimulation signal to one or more baroreceptors in the pulmonary artery via the at least one fixation electrode. The pressure sensor is anchorable in the pulmonary artery via the at least one fixation electrode.

Claims

1. An apparatus comprising:

at least one fixation electrode adapted to abut a wall of a pulmonary artery;

a pressure sensor integrally supported by the at least one fixation electrode, the pressure sensor providing a signal indicative of a blood pressure in the pulmonary artery;

a pulse generator coupled with the at least one fixation electrode, the pulse generator adapted to deliver a baroreflex stimulation signal to one or more baroreceptors in the pulmonary artery via the at least one fixation electrode; and

wherein the pressure sensor is anchorable in the pulmonary artery via the at least one fixation electrode.

2. The apparatus as recited in claim 1, wherein the at least one fixation electrode is expandable to fix the electrode and the pressure sensor in place by frictional forces.

3. The apparatus as recited in claim 1, wherein the at least one fixation electrode comprises, at least in part, an electrically insulated surface.

4. The apparatus as recited in claim 1, further comprising a second sensor adapted to sense a physiological parameter.

5. The apparatus as recited in claim 1, further comprising a posture sensor adapted to sense a posture signal, the posture signal for use in normalizing the signal indicative of the blood pressure in the pulmonary artery.

6. The apparatus as recited in claim 1, further comprising a controller coupled with one or both of the pressure sensor or the pulse generator, the controller adapted to control the baroreflex stimulation signal or receive the signal indicative of the pulmonary artery blood pressure.

7. The apparatus as recited in claim 6, further comprising an implantable medical device, the implantable medical device including the pulse generator, the controller, and an apparatus power source.

8. The apparatus as recited in claim 7, wherein the pressure sensor intermittently or continuously provides the signal indicative of the pulmonary artery blood pressure to the implantable medical device.

9. The apparatus as recited in claim 7, further comprising a lead body extending from a lead proximal end to a lead distal end, the lead body connecting the implantable medical device and the at least one fixation electrode;

and wherein the at least one fixation electrode is coupled near the lead distal end.

10. The apparatus as recited in claim 9, further comprising a second electrode coupled with the lead body proximally from the at least one fixation electrode.

11. The apparatus as recited in claim 6, wherein the coupling between the controller and one or both of the pressure sensor or pulse generator includes at least one wireless link.

12. The apparatus as recited in claim 11, further comprising an external device including the controller;

and wherein the pressure sensor provides the signal indicative of the pulmonary artery blood pressure to the external device at a predetermined time interval or in response to a user-generated command.

13. The apparatus as recited in claim 1, further comprising at least one apparatus power source adapted to provide power to the pressure sensor and the pulse generator.

14. The apparatus as recited in claim 13, wherein the at least one apparatus power source comprises a capacitor or a battery coupled with the pressure sensor, the capacitor chargeable by an external charger.

15. The apparatus as recited in claim 13, wherein the at least one apparatus power source comprises a battery coupled with the pressure sensor.

16. An apparatus comprising:

an expandable electrode having an expanded diameter dimensioned to abut a wall of a pulmonary artery;

a pulmonary artery pressure sensor coupled to the expandable electrode, the pressure sensor adapted to monitor blood pressure in the pulmonary artery;

a pulse generator electrically coupled with the expandable electrode, the pulse generator being adapted to deliver a baroreflex stimulation signal to a baroreceptors in the pulmonary artery by way of the expandable electrode; and

wherein the expandable electrode is adapted to fix the pulmonary artery pressure sensor in place by frictional forces.

17. The apparatus as recited in claim 16, wherein the expandable electrode includes an expandable stent structure adapted to be intravascularly delivered in a collapsed state and expanded when positioned in the pulmonary artery.

18. The apparatus as recited in claim 16, wherein the pulse generator is further adapted to generate a cardiac pacing signal;

and wherein the apparatus includes a second electrode positioned to deliver the cardiac pacing signal to capture a heart.

19. A method comprising:

forming an expandable electrode, including forming an expanded shape dimensioned to abut a wall of a pulmonary artery;

securing a pulmonary artery pressure sensor to the expandable electrode such that the pressure sensor is fixable in the pulmonary artery via the expandable electrode; and

wherein the expandable electrode and the pulmonary artery pressure sensor are adapted to be fed through a right ventricle and a pulmonary valve into the pulmonary artery.

20. The method as recited in claim 19, further comprising forming a pulse generator, including programming the pulse generator to deliver a baroreflex stimulation signal to a baroreceptors in the pulmonary artery via the expandable electrode;

and coupling the pulse generator with the expandable electrode.

21. A method of use comprising:

implanting an expandable electrode having an integrated pressure sensor within a pulmonary artery such that an outer surface of the electrode abuts a wall of the pulmonary artery;

monitoring a signal indicative of a blood pressure in the pulmonary artery using the pressure sensor; and

delivering a baroreflex stimulation signal to one or more baroreceptors in the pulmonary artery via the electrode.

22. The method as recited in claim 21, further comprising comparing the signal indicative of the pulmonary artery blood pressure with a predetermined pressure signal threshold.

23. The method as recited in claim 22, wherein delivering the baroreflex stimulation includes using the comparison between the signal indicative of the pulmonary artery blood pressure and the predetermined pressure signal threshold.

24. The method as recited in claim 21, wherein implanting includes feeding the expandable electrode integrated with the pressure sensor through a right ventricle and a pulmonary valve into the pulmonary artery to position the electrode and sensor.

25. The method as recited in claim 21, further comprising modifying the baroreflex stimulation signal using the signal indicative of the blood pressure in the pulmonary artery.

26. The method as recited in claim 21, further comprising monitoring a signal indicative of a then-current posture;

and normalizing the signal indicative of the blood pressure in the pulmonary artery using the signal indicative of the then-current posture.