Lead for stimulating the baroreceptors in the pulmonary artery

• US 8,473,076 B2
• Filed: 09/06/2011
• Issued: 06/25/2013
• Est. Priority Date: 12/24/2003
• Status: Expired due to Fees

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Libbus, Imad, Heil, Ronald W. Jr., Scheiner, Avram
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Sarcione, Jessica
• Application Number:
  US13/225,769
• Publication Number:
  US 20110319960A1
• Time in Patent Office: 658 Days
• Field of Search: 607148-149
• US Class Current: 607/148
• CPC Class Codes: A61N 1/0476 Array electrodes (including any electrode arrangement with more than one electrode for at least one of the polarities)
• 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 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/057 Anchoring means; Means for fixing the head inside the heart
• CPC Class Codes: A61N 1/36117 for treating hypertension

Abstract

An apparatus includes a flexible lead body extending from a proximal end to a distal end, an expandable electrode coupled proximate the distal end, the expandable electrode having an expanded diameter dimensioned to abut a wall of a pulmonary artery, and an implantable pulse generator electrically coupled to the expandable electrode. The expandable electrode includes a plurality of electrode zones. The plurality of zones can be tested to determine which zone delivers the best baroreflex response. At least one of the electrode zones can be selected to deliver a stimulation signal based on the testing. The implantable pulse generator is adapted to deliver a baroreflex stimulation signal to a baroreceptor in the pulmonary artery via the electrode.

Claims

1. A method comprising:

implanting an expandable electrode within a pulmonary artery such that an outer surface of the expandable electrode abuts a wall of the pulmonary artery, the expandable electrode comprising a plurality of electrode zones, each zone individually coupled to a separate conductor of the lead body;

testing each of the electrode zones to determine which zone delivers the best baroreflex response;

selecting at least one of the electrode zones based on the testing; and

delivering a baroreflex stimulation signal to a baroreceptor in the pulmonary artery via the one or more selected electrodes, wherein the implantable pulse generator is programmed such that the signal is delivered for about 5 seconds to about 10 seconds each minute at a voltage of about 0.1 volts to about 10 volts and a frequency of about 10 Hz to 150 Hz.

2. The method of claim 1, wherein implanting includes implanting an expandable electrode having an expanded diameter dimensioned to fix the electrode in place by frictional forces.

3. The method of claim 1, wherein the electrode is adapted to be chronically implanted in the pulmonary artery.

4. The method of claim 1, further including monitoring a blood pressure.

5. The method of claim 1, wherein implanting includes implanting the electrode proximate the ligamentum arteriosum of the left pulmonary artery.

6. The method of claim 1, wherein implanting includes feeding the electrode through a right ventricle and a pulmonary valve into the pulmonary artery to position the electrode in the pulmonary artery.

7. The method of claim 1, wherein implanting includes implanting an expandable electrode having an expanded diameter of about 10 to 20 mm.

8. The method of claim 1, wherein delivering a baroreflex stimulation signal includes an at least 10 hertz pulse train via the electrode.

9. The method of claim 1, wherein the expandable electrode includes a stent-like structure.

10. The method of claim 1, wherein each electrode zone individually coupled to a separate conductor within the lead body.

11. The method of claim 1, wherein the expandable electrode includes at least a partially electrically insulated surface.

12. The method of claim 1, further including sensing a physiological parameter regarding an efficacy of the baroreflex stimulation and providing a signal indicative of the efficacy of the baroreflex stimulation.

13. The method of claim 12, further including receiving the signal at a controller and using the controller to control the baroreflex stimulation pulse.

14. A method comprising:

providing a flexible lead body extending from a proximal end to a distal end with an expandable electrode coupled to the lead body, the expandable electrode comprising a plurality of electrode zones, each electrode zone individually coupled to a separate conductor within the lead body;

coupling the expandable electrode to an implantable pulse generator;

implanting the expandable electrode in a pulmonary artery proximate a baroreceptor;

testing each electrode zone separately to determine which electrode zone delivers the best baroreflex response;

selecting at least one of the electrode zones to deliver a baroreflex stimulation signal to the baroreceptor in the pulmonary artery to produce a baroreflex response; and

delivering a baroreflex stimulation signal to the baroreceptor in the pulmonary artery via the at least one selected electrode zone, wherein the baroreflex stimulation signal is delivered for about 5 seconds to about 10 seconds each minute at a voltage of about 0.1 volts to about 10 volts and a frequency of about 10 Hz to 150 Hz.

15. The method of claim 14, wherein delivering the baroreflex stimulation signal includes delivering about a 10 hertz pulse train via the electrode.

16. The method of claim 14, wherein delivering the baroreflex stimulation signal to the baroreceptor causes a lowering of blood pressure.

17. The method of claim 14, wherein the expandable electrode comprises an expandable stent structure coupled to the lead body for passively fixating the expandable electrode in the pulmonary artery.

18. The method of claim 17, wherein the stent structure includes an expanded diameter dimensioned to abut a wall of the pulmonary artery.