External baroreflex activation

• US 20060293712A1
• Filed: 03/02/2005
• Published: 12/28/2006
• Est. Priority Date: 03/02/2004
• Status: Active Grant

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Rossing, Martin A., Kieval, Robert S.
• Granted Patent: US 7,499,747 B2
• Time in Patent Office: Days
• US Class Current: 607/2
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362

Abstract

Methods and systems for external baroreflex activation allow a physician to characterize a patient'"'"'s response to baroreflex activation prior to providing baroreflex activation therapy. Methods generally include applying a baroreflex activation stimulus to a patient, measuring one or more physiological parameters of the patient, and determining the extent to which the baroreflex activation causes a baroreflex response. Multiple stimuli of different intensities and/or from different locations may be compared. Systems include one or more external baroreflex activation devices and one or more physiological parameter measuring devices. Optionally, a system may also include one or more fully or partially implantable devices for providing baroreflex activation therapy.

Claims

1. A method for testing response to baroreflex activation in a patient, the method comprising:

applying at least a first baroreflex activation stimulus to the patient from a location external to the patient;

measuring at least one physiological parameter of the patient; and

determining, from the physiological parameter measurement, to what extent the first baroreflex activation stimulus caused a baroreflex response in the patient.

2. A method as in claim 1, wherein applying the baroreflex activation stimulus comprises at least one of transmitting energy from at least one energy transmitting device, mechanically stimulating an area approximating one or more carotid arteries, and introducing one or more drugs into the patient.

3. A method as in claim 2, wherein the transmitted energy comprises at least one of ultrasonic, electromagnetic, radiofrequency and microwave energy.

4. A method as in claim 3, wherein the transmitted energy comprises electromagnetic energy using at least one electrode external to the patient.

5. A method as in claim 3, wherein the transmitted energy comprises transcutaneous electrical nerve stimulation.

6. A method as in claim 1, wherein the first baroreflex activation stimulus is applied so as to activate at least one carotid sinus baroreceptor.

7. A method as in claim 1, wherein the first baroreflex activation stimulus is applied so as to activate at least one baroreceptor other than a carotid sinus baroreceptor.

8. A method as in claim 1, wherein the first baroreflex activation stimulus is applied so as to activate at least one carotid sinus nerve fiber.

9. A method as in claim 1, wherein the first baroreflex activation stimulus is applied so as to activate at least one nerve fiber other than a carotid sinus nerve fiber.

10. A method as in claim 1, wherein measuring the physiological parameter comprises measuring at least one of blood pressure, change in blood pressure, heart rate, cardiac output, vascular resistance, seizure activity, neurological activity and pain sensation.

11. A method as in claim 1, wherein determining comprises comparing the physiological parameter measurement to a baseline measurement.

12. A method as in claim 11, further comprising measuring the baseline measurement of the physiological parameter of the patient before applying the baroreflex activation stimulus.

13. A method as in claim 1, wherein determining comprises comparing the physiological parameter measurement to a predetermined threshold measurement.

14. A method as in claim 1, further comprising determining whether to place an implantable baroreflex activation device in the patient, based on the extent to which the baroreflex activation stimulus caused the baroreflex response.

15. A method as in claim 14, further comprising determining one or more locations in the patient'"'"'s body in which to place the implantable device.

16. A system as in claim 15, wherein determining the one or more locations comprises determining whether to place the implantable device in a left side and/or a right side of the patient'"'"'s neck.

17. A method as in claim 14, further comprising placing at least one implantable baroreflex activation device in the patient.

18. A method as in claim 17, wherein at least part of the baroreflex activation device is placed external to the patient'"'"'s body.

19. A method as in claim 1, further comprising:

applying a second baroreflex activation stimulus to the patient from the location external to the patient, the second stimulus having at least one different characteristic than the first stimulus;

measuring at least one physiological parameter of the patient; and

determining, from the physiological parameter measurement, to what extent the second baroreflex activation stimulus caused a baroreflex response in the patient.

20. A method as in claim 19, further comprising:

repeating the applying, measuring and determining steps multiple times, each time applying a baroreflex activation stimulus having at least one different characteristic; and

generating data describing the extent to which different baroreflex stimuli cause different baroreflex responses.

21. A method as in claim 20, wherein the at least one different characteristic comprises at least one of intensity, pulse amplitude, pulse width and pulse frequency.

22. A method as in claim 20, further comprising selecting one baroreflex stimulus for treating the patient, based on the data.

23. A method as in claim 20, further comprising applying at least some of the baroreflex stimuli from different locations external the patient than other baroreflex stimuli, wherein the generated data further describe the extent to which baroreflex stimuli from different external locations cause different baroreflex responses.

24. A method as in claim 23, further comprising selecting one baroreflex stimulus and one location for applying the baroreflex stimulus for treating the patient, based on the data.

25. A system for testing response to baroreflex activation in a patient, the system comprising:

at least one external baroreflex activation device for applying at least one baroreflex activation stimulus to the patient from a location external to the patient; and

at least one physiological parameter measuring device for measuring a physiological parameter of the patient to determine to what extent the applied stimulus caused a baroreflex activation in the patient.

26. A system as in claim 25, wherein the at least one external baroreflex activation device is selected from the group consisting of an energy transmission device, a mechanical force application device and a drug delivery device.

27. A system as in claim 26, wherein the energy transmission device is selected from the group consisting of an ultrasonic, electromagnetic, radiofrequency and microwave energy device.

28. A system as in claim 27, wherein the energy transmission device comprises an ultrasonic energy transmission device for externally activating at least one of carotid sinus baroreceptors, other baroreceptors, carotid sinus nerve fibers, nerve fibers connected to one or more baroreceptors, and other nerve fibers.

29. A system as in claim 27, wherein the energy transmission device comprises at least one electrode for externally activating at least one of carotid sinus baroreceptors, other baroreceptors, carotid sinus nerve fibers, nerve fibers connected to one or more baroreceptors, and other nerve fibers.

30. A system as in claim 27, wherein the energy transmission device comprises at least one transcutaneous electrical nerve stimulator device for externally activating at least one of carotid sinus baroreceptors, other baroreceptors, carotid sinus nerve fibers, nerve fibers connected to one or more baroreceptors, and other nerve fibers.

31. A system as in claim 25, wherein the at least one physiological parameter measuring device comprises at least one surface electrode for contacting with the patient'"'"'s skin to measure the physiological parameter.

32. A system as in claim 25, wherein the at least one physiological parameter measuring device comprises at least one piezoelectric sensor for contacting with the patient'"'"'s skin to measure the physiological parameter.

33. A system as in claim 25, wherein the at least one physiological parameter measuring device is selected from the group consisting of a blood pressure cuff, a pulse oximetry device, a Swan-Ganz catheter, a device for measuring cardiac output, a device for measuring vascular resistance and an electroencephalogram device.

34. A system as in claim 25, wherein the at least one physiological parameter measuring device measures at least one of blood pressure, change in blood pressure, heart rate, cardiac output, vascular resistance, seizure activity, neurological activity and pain sensation.

35. A system as in claim 25, further comprising a processor for receiving physiological parameter measurements from the measuring device and processing the measurements into data in a usable form.

36. A system as in claim 35, wherein the processor compares the measured physiological parameter data to one or more baseline measurement values to determine whether the applied stimulus has caused baroreflex activation in the patient.

37. A system as in claim 36, further comprising a display monitor coupled with the processor for displaying measured physiological parameter data to a user.

38. A system as in claim 25, further comprising at least one implantable baroreflex activation device for placing in the patient.

39. A system as in claim 38, wherein the implantable baroreflex activation device is coupled with another implantable device for performing another function in the patient.

40. A system as in claim 39, wherein the other implantable device is selected from the group consisting of a cardiac pacemaker, an implantable defibrillator, an implantable cardioverter defibrillator, a drug pump and a neurostimulator.

41. A system as in claim 38, wherein at least part of the implantable baroreflex activation device is disposed external to the patient'"'"'s body.