Baroreflex stimulator with integrated pressure sensor

• US 20050149143A1
• Filed: 12/24/2003
• Published: 07/07/2005
• 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: Salo, Rodney W., Libbus, Imad
• Granted Patent: US 7,869,881 B2
• Time in Patent Office: Days
• US Class Current: 607/44
• CPC Class Codes: A61N 1/36057 adapted for stimulating afferent nerves
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: A61N 1/36564 controlled by blood pressure

Abstract

An aspect relates to an implantable medical device. An embodiment of the device comprises a pulse generator, sensor circuitry, a lead, and a controller. The pulse generator generates baroreflex stimulation pulses. The lead is adapted to be electrically connected to the pulse generator and to the sensor circuitry. The lead includes an electrode to distribute the baroreflex stimulation pulses to a baroreflex site and a pressure sensor to provide a signal indicative of blood pressure to the sensor circuitry. The controller is connected to the pulse generator and the sensor circuitry. The controller adapted to adjust the baroreflex stimulation pulses based on the blood pressure. Other aspects are provided herein.

Claims

1. An implantable medical device, comprising:

a pulse generator to generate baroreflex stimulation pulses;

a sensor circuitry;

a lead adapted to be electrically connected to the pulse generator and to the sensor circuitry, the lead including an electrode to distribute the baroreflex stimulation pulses to a baroreflex site and a pressure sensor to provide a signal indicative of blood pressure to the sensor circuitry; and

a controller connected to the pulse generator and the sensor circuitry, the controller adapted to adjust the baroreflex stimulation pulses based on the blood pressure.

2. The device of claim 1, wherein the controller is adapted to modulate an amplitude of the baroreflex stimulation pulses based on the blood pressure.

3. The device of claim 1, wherein the controller is adapted to modulate a frequency of the baroreflex stimulation pulses based on the blood pressure.

4. The device of claim 1, wherein the controller is adapted to modulate a pulse frequency of the baroreflex stimulation pulses based on the blood pressure.

5. The device of claim 1, wherein the controller is adapted to change a morphology of the baroreflex stimulation pulses based on the blood pressure.

6. The device of claim 1, wherein the controller is adapted to modulate two or more characteristics selected from a group of characteristics consisting of an amplitude, a frequency, and a pulse frequency.

7. The device of claim 1, wherein the lead is adapted to be fed through a right ventricle and a pulmonary valve into a pulmonary artery, the electrode is positioned to stimulate a baroreflex site in the pulmonary artery, and the pressure sensor is positioned to sense blood pressure in the pulmonary artery.

8. The device of claim 1, wherein the lead is adapted to be intravascularly fed into a blood vessel proximate to an afferent nerve, the electrode is positioned in the blood vessel to stimulate the afferent nerve, and the pressure sensor is positioned proximate to the electrode in the blood vessel.

9. The device of claim 1, wherein the lead is adapted to be intravascularly fed to position the electrode proximate to a cardiac fat pad and the pressure sensor is positioned proximate to the electrode.

10. The device of claim 1, wherein the pressure sensor includes a micro-electrical mechanical system (MEMS) device to detect blood pressure.

11. The device of claim 1, wherein the pressure sensor includes a membrane and means to detect displacement of the membrane.

12. An implantable medical device, comprising:

means for delivering baroreflex therapy to a baroreflex neural target site using an intravascular lead and an electrode on the lead;

means for monitoring blood pressure near the baroreflex neural target site using a pressure sensor on the lead; and

means for adjusting the baroreflex therapy based on the blood pressure.

13. The device of claim 12, wherein the means for adjusting the baroreflex therapy includes means for modulating an amplitude of a stimulation pulse.

14. The device of claim 12, wherein the means for adjusting the baroreflex therapy includes means for modulating a frequency of a stimulation pulse.

15. The device of claim 12, wherein the means for adjusting the baroreflex therapy includes means for modulating a pulse frequency of a stimulation pulse.

16. The device of claim 12, wherein the means for adjusting the baroreflex therapy includes means for modulating a morphology of a stimulation pulse.

17. The device of claim 12, wherein:

means for delivering baroreflex therapy to a baroreflex neural target site includes means for delivering baroreflex therapy to a baroreceptor site using an electrode in a pulmonary artery; and

means for monitoring blood pressure near the baroreflex neural target site using a pressure sensor on the lead includes means for monitoring blood pressure in the pulmonary artery.

18. The device of claim 12, wherein means for monitoring blood pressure near the baroreflex neural target site using a pressure sensor on the lead includes a wireless device adapted to be positioned within a pulmonary artery, the wireless device includes means for wirelessly communicating with another device.

19. The device of claim 18, wherein the wireless device further includes means for stimulating local baroreceptors.

20. The device of claim 18, wherein the means for wirelessly communicating with another device includes means for wirelessly communicating with another implantable device.

21. The device of claim 18, wherein the means for wirelessly communicating with another device includes means for wirelessly communicating with an external device.

22. The device of claim 18, wherein the means for wirelessly communicating with another device includes means for ultrasonically communicating with another device.

23. The device of claim 18, wherein the means for wirelessly communicating with another device includes means for electromagnetically communicating with another device.

24. The device of claim 12, wherein:

means for delivering baroreflex therapy to a baroreflex neural target site includes means for delivering baroreflex therapy to a baroreflex neural target site in a cardiac fat pad using an electrode in a blood vessel proximate to the cardiac fat pad; and

means for monitoring blood pressure near the baroreflex neural target site using a pressure sensor on the lead includes means for monitoring blood pressure in the blood vessel proximate to the cardiac fat pad.

25. An implantable medical device, comprising:

a pulse generator to generate baroreflex stimulation pulses;

a sensor circuitry;

a lead adapted to be electrically connected to the pulse generator and to the sensor circuitry, the lead including an electrode to distribute the baroreflex stimulation pulses to a baroreflex site and a sensor to provide a signal to the sensor circuitry that corresponds to a pre-ejection period measured between a sensed electrical event in a ventricle and onset of ventricular ejection derived from a pulmonary arterial blood pressure sensor; and

a controller connected to the pulse generator and the sensor circuitry, the controller adapted to adjust the baroreflex stimulation pulses based on the blood pressure.

26. The device of claim 25, wherein the sensed electrical event in a ventricle includes a sensed electrical event in a right ventricle.

27. The device of claim 25, wherein the sensed electrical event in a ventricle includes a sensed electrical event in a left ventricle.

28. The device of claim 25, wherein the controller is adapted to modulate an amplitude of the baroreflex stimulation pulses based on the pre-ejection period.

29. The device of claim 25, wherein the controller is adapted to modulate a frequency of the baroreflex stimulation pulses based on the pre-ejection period.

30. The device of claim 25, wherein the controller is adapted to modulate a pulse frequency of the baroreflex stimulation pulses based on the pre-ejection period.

31. The device of claim 25, wherein the controller is adapted to change a morphology of the baroreflex stimulation pulses based on the pre-ejection period.

32. The device of claim 25, wherein the controller is adapted to modulate two or more characteristics selected from a group of characteristics consisting of an amplitude, a frequency, and a pulse frequency.

33. An implantable medical device, comprising:

a pulse generator to generate baroreflex stimulation pulses;

a sensor circuitry to sense cardiac output or sympathetic tone;

a lead adapted to be electrically connected to the pulse generator and to the sensor circuitry, the lead including an electrode to distribute the baroreflex stimulation pulses to a baroreflex site; and

a controller connected to the pulse generator and the sensor circuitry, the controller adapted to provide the baroreflex stimulation pulses during application of post myocardial infarction regional unloading therapy to moderate an associated increase in sympathetic tone accompanying a decrease in global cardiac function, and to adjust the baroreflex stimulation pulses to maintain a desired parameter in a desired range during the application of unloading therapy for remodeling control.

34. The device of claim 33, wherein the desired parameter includes a cardiac output parameter.

35. The device of claim 33, wherein the desired parameter includes a sympathetic tone parameter.

36. The device of claim 33, wherein the controller is adapted to modulate an amplitude of the baroreflex stimulation pulses based on the desired parameter.

37. The device of claim 33, wherein the controller is adapted to modulate a frequency of the baroreflex stimulation pulses based on the desired parameter.

38. The device of claim 33, wherein the controller is adapted to modulate a pulse frequency of the baroreflex stimulation pulses based on the desired parameter.

39. The device of claim 33, wherein the controller is adapted to change a morphology of the baroreflex stimulation pulses based on the desired parameter.

40. The device of claim 33, wherein the controller is adapted to modulate two or more characteristics selected from a group of characteristics consisting of an amplitude, a frequency, and a pulse frequency.

41. A method, comprising:

delivering baroreflex therapy to a baroreflex neural target site using an intravascular lead and an electrode on the lead;

monitoring blood pressure near the baroreflex neural target site using a pressure sensor on the lead; and

adjusting the baroreflex therapy based on the blood pressure.

42. The method of claim 41, wherein adjusting the baroreflex therapy includes modulating an amplitude of a stimulation pulse.

43. The method of claim 41, wherein adjusting the baroreflex therapy includes modulating a frequency of a stimulation pulse.

44. The method of claim 41, wherein adjusting the baroreflex therapy includes modulating a pulse frequency of a stimulation pulse.

45. The method of claim 41, wherein adjusting the baroreflex therapy includes modulating a morphology of a stimulation pulse.

46. The method of claim 41, wherein:

delivering baroreflex therapy to a baroreflex neural target site includes delivering baroreflex therapy to a baroreceptor site near the pulmonary artery using a lead fed through a right ventricle and a pulmonary valve into the pulmonary artery;

monitoring blood pressure near the baroreflex neural target site using a pressure sensor on the lead includes monitoring blood pressure in the pulmonary artery.

47. The method of claim 41, wherein:

delivering baroreflex therapy to a baroreflex neural target site includes delivering baroreflex therapy to a baroreflex neural target site near the pulmonary artery using a lead fed through a right ventricle and a pulmonary valve into the pulmonary artery; and

monitoring blood pressure near the baroreflex neural target site using a pressure sensor on the lead includes monitoring blood pressure in the pulmonary artery.

48. The method of claim 41, wherein:

delivering baroreflex therapy to a baroreflex neural target site includes delivering baroreflex therapy to a baroreflex neural target site in a cardiac fat pad; and

monitoring blood pressure near the baroreflex neural target site using a pressure sensor on the lead includes monitoring blood pressure in a vessel proximate to the cardiac fat pad.

49. The method of claim 41, wherein:

delivering baroreflex therapy to a baroreflex neural target site includes delivering baroreflex therapy to an afferent nerve through an electrode intravascularly fed into a vessel proximate to the afferent nerve and functionally positioned to stimulate the afferent nerve through a vessel wall; and

monitoring blood pressure near the baroreflex neural target site using a pressure sensor on the lead includes monitoring blood pressure in the vessel proximate to the afferent nerve.