Stimulation lead for stimulating the baroreceptors in the pulmonary artery

• US 8,126,560 B2
• Filed: 12/24/2003
• Issued: 02/28/2012
• Est. Priority Date: 12/24/2003
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Scheiner, Avram, Heil, Ronald W. Jr., Kelley, Peter T.
• Primary Examiner(s): Layno, Carl H.
• Assistant Examiner(s): MORALES, JON ERIC C
• Application Number:
  US10/746,852
• Publication Number:
  US 20050149155A1
• Time in Patent Office: 2,988 Days
• Field of Search: 607/125, 607/9, 607/42, 607/44
• US Class Current: 607/44
• 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, the distal end having a biased portion having an outer diameter dimensioned to abut a wall of a pulmonary artery, an electrode coupled proximate the distal end, and an implantable pulse generator electrically coupled to the electrode. The implantable pulse generator is adapted to deliver a baroreflex stimulation signal to a baroreceptor in the pulmonary artery via the electrode.

Claims

1. An apparatus comprising:

a flexible lead body extending from a proximal end to a distal end, the distal end having a biased portion having an outer diameter dimensioned to abut a wall of a pulmonary artery;

an electrode coupled proximate the distal end; and

an implantable pulse generator electrically coupled to the electrode, wherein the implantable pulse generator is programmed to deliver a baroreflex stimulation signal to a baroreceptor in the pulmonary artery via the electrode such that the stimulation signal causes a lowering of blood pressure, 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 apparatus of claim 1, wherein the biased portion has an outer diameter between about 10 mm and about 20 mm.

3. The apparatus of claim 1, wherein the biased portion is adapted to fix the lead in place by frictional forces.

4. The apparatus of claim 1, wherein the biased portion includes a spiral configuration.

5. The apparatus of claim 1, wherein the electrode includes a porous surface.

6. The apparatus of claim 1, wherein the lead includes two or more discrete electrodes located on the biased portion of the lead.

7. The apparatus of claim 1, wherein the lead includes a second electrode located proximally from the distal end.

8. The apparatus of claim 1, wherein the signal is at a voltage of about 1 V to about 10 V.

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

10. The apparatus of claim 1, wherein the lead further includes a sensor to monitor blood pressure.

11. The apparatus of claim 1, wherein the electrode is adapted to be located near the ligamentum arteriosum of the left pulmonary artery.

12. The apparatus of claim 1, further including a sensor to sense a physiological parameter regarding an efficacy of the baroreflex therapy and to provide a signal indicative of the efficacy of the baroreflex therapy.

13. The apparatus of claim 12, further including a controller connected to the pulse generator to control the baroreflex stimulation signal and to the sensor to receive the signal indicative of the efficacy of the baroreflex therapy.

14. The apparatus of claim 1, wherein the lead is adapted to be fed through a right ventricle and a pulmonary valve into the pulmonary artery to position the electrode in the pulmonary artery.

15. The apparatus of claim 1, wherein the pulse generator is further adapted to generate a cardiac pacing signal, the lead further including a second electrode to be positioned to deliver the cardiac pacing signal to capture the heart.

16. The apparatus of claim 1, wherein the implantable pulse generator is programmed to deliver the baroreflex stimulation signal to the baroreceptor such that the stimulation signal causes a lowering of blood pressure.

17. An apparatus comprising:

a flexible lead body extending from a proximal end to a distal end;

an electrode coupled to the distal end of the lead body; and

an implantable pulse generator electrically coupled to the electrode, the implantable pulse generator being programmed to deliver a baroreflex stimulation signal to a baroreceptor in the pulmonary artery via the electrode;

wherein a biased portion of the distal end is adapted to passively fixate the electrode within the pulmonary artery;

wherein the implantable pulse generator is programmed to deliver the baroreflex stimulation signal to the baroreceptor such that the stimulation signal causes a lowering of blood pressure, wherein 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.

18. The apparatus of claim 17, wherein the biased portion includes a spiral structure.

19. The apparatus of claim 17, wherein the biased portion includes a circular structure.

20. The apparatus of claim 17, wherein the biased portion includes an outer diameter between about 10 mm to about 20 mm.

21. The apparatus of claim 17, wherein the signal is at a voltage of about 1 V to about 10 V.

22. The apparatus of claim 17, wherein the implantable pulse generator is programmed to deliver the baroreflex stimulation signal to the baroreceptor such that the stimulation signal causes a lowering of blood pressure.

23. A method comprising:

positioning an electrode on a distal end of a lead within a pulmonary artery, such that the electrode is adjacent a baroreceptor site; and

delivering a baroreflex stimulation pulse train to a baroreceptor in the pulmonary artery via the electrode, the pulse train being 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.

24. The method of claim 23, wherein positioning the electrode includes providing the distal end of the lead with a biased portion such that at least a portion of an outer diameter of the biased portion abuts a wall of the pulmonary artery.

25. The method of claim 24, wherein positioning includes positioning a biased portion having an outer diameter of about 10 to 20 mm.

26. The method of claim 24, wherein positioning includes positioning the biased portion to fix the electrode in place by frictional forces.

27. The method of claim 23, wherein positioning the electrode includes providing the distal end with a positive fixation mechanism to implant the electrode against a wall of the pulmonary artery.

28. The method of claim 23, wherein the electrode is adapted to be chronically implanted in the pulmonary artery.

29. The method of claim 23, further including monitoring a blood pressure to sense an efficacy of the baroreflex stimulation pulse train and to provide a signal indicative of the efficacy of the baroreflex stimulation pulse train.

30. The method of claim 23, wherein positioning includes positioning the electrode proximate the ligamentum arteriosum of the left pulmonary artery.

31. The method of claim 23, wherein positioning includes feeding the electrode through a right ventricle and a pulmonary valve into the pulmonary artery to position the electrode in the pulmonary artery.

32. The method of claim 23, wherein delivering a baroflex stimulation pulse train includes an at least 10 hertz pulse train via the electrode.

33. A method comprising:

positioning an electrode on a distal end of a lead within a pulmonary artery, such that the electrode is adjacent a baroreceptor site; and

delivering a baroreflex stimulation pulse train to a baroreceptor in the pulmonary artery via the electrode, wherein positioning the electrode includes chronically implanting the electrode proximate the ligamentum arteriosum of the left pulmonary artery, and wherein delivering the baroreflex stimulation pulse train includes delivering a baroreflex stimulation signal to the baroreceptor such that the stimulation signal causes a lowering of blood pressure, wherein 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.

34. The method of claim 33, further including monitoring a blood pressure to sense an efficacy of the baroreflex stimulation pulse train and to provide a signal indicative of the efficacy of the baroreflex stimulation pulse train.