Devices and methods for treatment of heart failure and associated conditions

• US 8,600,511 B2
• Filed: 10/04/2012
• Issued: 12/03/2013
• Est. Priority Date: 06/16/2008
• Status: Active Grant

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Yared, Nadim, Georgakopoulos, Dimitrios, Lovett, Eric Grant
• Primary Examiner(s): Layno, Carl H
• Assistant Examiner(s): Stice, Paula J
• Application Number:
  US13/645,122
• Publication Number:
  US 20130030309A1
• Time in Patent Office: 425 Days
• Field of Search: 607/44
• US Class Current: 607/44
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/02007 Evaluating blood vessel condition, e.g. elasticity, compliance
• CPC Class Codes: A61B 5/02108 from analysis of pulse wave characteristics
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/053 Measuring electrical impedance or conductance of a portion of the body
• CPC Class Codes: A61N 1/36117 for treating hypertension

Abstract

Devices and methods of use are described for identification, treatment, and/or management of heart failure and/or associated conditions. An exemplary system may include a baroreflex activation device configured to be implantable proximate a blood vessel of a patient, a measurement device configured to be implantable proximate a blood vessel, and a control system coupled to the baroreflex activation device and the measurement device and in communication with a blood pressure sensing means. The control system is programmed to automatically determine pressure waveform data from the measurement device over a time period of at least a portion of one cardiac cycle, determine a patient physiological parameter based on the pressure waveform data, and compare the patient physiological parameter to a blood pressure measurement taken from the blood pressure sensing means.

Claims

1. An implantable baroreflex system, comprising:

a baroreflex activation device configured to be implantable proximate a blood vessel of a patient;

a measurement device configured to be implantable proximate a blood vessel; and

a control system coupled to the baroreflex activation device and the measurement device, and in communication with a blood pressure sensing means, the control system programmed to automatically;

determine an impedance of the blood vessel with the measurement device;

determine waveform data based on the blood vessel impedance over a time period of at least a portion of one cardiac cycle;

determine a patient physiological parameter based on the waveform data; and

compare the patient physiological parameter to a blood pressure measurement taken from the blood pressure sensing means.

2. The system of claim 1, wherein the baroreflex activation device comprises an electrode.

3. The system of claim 1, wherein the measurement device comprises an electrode.

4. The system of claim 1, wherein the measurement device is integrated with the baroreflex activation device.

5. The system of claim 1, wherein the measurement device comprises an implantable pressure transducer.

6. The system of claim 1, wherein the blood pressure sensing means is implantable within the patient and coupled to the control system.

7. The system of claim 1, wherein the blood pressure sensing means comprises an implantable blood pressure sensor.

8. The system of claim 1, wherein the blood pressure sensing means comprises a sphygmomanometer.

9. The system of claim 1, wherein the patient physiological parameter comprises blood pressure.

10. The system of claim 1, wherein the patient physiological parameter comprises heart rate.

11. The system of claim 1, wherein the patient physiological parameter comprises one of vascular stiffness, or augmentation index.

12. The system of claim 1, wherein the control system is further programmed to automatically activate, deactivate or otherwise modulate the baroreflex activation device to deliver a baroreflex therapy based on the comparison of the patient physiological parameter to the blood pressure measurement.

13. The system of claim 12, wherein the control system contains pre-determined ranges for each of the patient physiological parameter and blood pressure, the control system being further programmed to:

deliver a first therapy when the patient physiological parameter and the blood pressure measurement are each within the pre-determined ranges; and

deliver a second therapy when the patient physiological parameter and the blood pressure measurement each deviate from the pre-determined ranges.

14. The system of claim 12, wherein the control system contains pre-determined ranges for each of the patient physiological parameter and blood pressure, the control system being further programmed to:

deliver a first therapy when the patient physiological parameter is within the pre-determined range and the blood pressure measurement exceeds the pre-determined range; and

deliver a second therapy when the patient physiological parameter and the blood pressure measurement each deviate from the pre-determined ranges.

15. The system of claim 1, further comprising a heart rate sensing means in communication with the control system, the control system being further programmed to automatically compare the patient physiological parameter to a heart rate obtained from the heart rate sensing means.

16. The system of claim 15, wherein the control system contains pre-determined ranges for each of the patient physiological parameter, blood pressure, and heart rate, the control system being further programmed to:

deliver a first therapy when the patient physiological parameter and/or heart rate are within their pre-determined ranges and the blood pressure deviates from the pre-determined range; and

deliver a second therapy when at least one of the patient physiological parameter or heart rate deviates from their pre-determined ranges.

17. The implantable baroreflex system of claim 1, wherein the baroreflex activation device comprises a therapy electrode configured to be implantable in contact with a wall of the blood vessel, and wherein the measurement device comprises a measurement electrode configured to be implantable in contact with the wall of the blood vessel and proximate the baroreflex activation device.

18. A method, comprising:

causing a baroreflex therapy system to be manufactured and made available to a user, wherein manufacture of the baroreflex therapy system further comprise;

constructing a baroreflex activation device, constructing a measurement device, and constructing a control system coupled to the baroreflex activation device and the measurement device;

causing a blood pressure sensing means to be manufactured and made available to a user, the blood pressure sensing means in communication with the control system; and

providing instructions to the user recorded on a tangible medium, the instructions comprising;

implanting the activation device proximate a blood vessel of a patient;

implanting the measurement device proximate a blood vessel; and

causing the control system to;

determine an impedance of the blood vessel with the measurement device;

determine waveform data based on the blood vessel cycle;

determine a patient physiological parameter based on the waveform data;

obtain a blood pressure measurement via the blood pressure sensing means; and

compare the blood pressure measurement to the patient physiological parameter.

19. The method of claim 18, wherein the instructions further include causing the control system to activate, deactivate or otherwise modulate the baroreflex therapy system to deliver a baroreflex therapy via the baroreflex activation device based on the comparison of the patient physiological parameter to the blood pressure measurement.

20. The method of claim 19, wherein the control system contains pre-determined ranges for each of the patient physiological parameter and blood pressure, the instructions further comprising causing the control system to:

deliver a first therapy when the patient physiological parameter and the blood pressure measurement are each within the pre-determined ranges; and

deliver a second therapy when the patient physiological parameter and the blood pressure measurement each deviate from the pre-determined ranges.

21. The method of claim 19, wherein the control system contains pre-determined ranges for each of the patient physiological parameter and blood pressure, the instructions further comprising causing the control system to:

deliver a first therapy when the patient physiological parameter is within the predetermined range and the blood pressure measurement exceeds the pre-determined range; and

deliver a second therapy when the patient physiological parameter and the blood pressure measurement each deviate from the pre-determined ranges.

22. The method of claim 18, wherein the baroreflex activation device comprises a therapy electrode and wherein the measurement device comprises a measurement electrode, the instructions further comprising:

implanting the activation device such that the therapy electrode is in contact with a wall of the blood vessel; and

implanting the measurement device such that the electrode is in contact with the wall of the blood vessel and proximate the therapy electrode.

23. The method of claim 18, the instructions further comprising:

implanting at least one of the activation device and the measurement device proximate a blood vessel of a patient selected from the group consisting of;

a carotid sinus, an aortic arch, a common carotid artery, a subclavian artery, a brachiocephalic artery, pulmonary artery, pulmonary vein, jugular vein, femoral artery, femoral vein, and a heart.

24. A method of comparing parameters, comprising:

providing an implantable baroreflex therapy system, including a baroreflex activation device having a therapy electrode, a measurement device having a measurement electrode, and a control system coupled to the baroreflex activation device and the measurement device;

providing a blood pressure sensing means in communication with the control system; and

implanting the baroreflex therapy system such that the therapy electrode is proximate a blood vessel of a patient and the measurement electrode is proximate the blood vessel,

wherein the control system is programmed to;

determine an impedance of the blood vessel with the implantable measurement device over a time period of at least one cardiac cycle;

determine a patient physiological parameter based on the impedance of the blood vessel;

obtain a blood pressure measurement via the blood pressure sensing means; and

compare the blood pressure measurement to the patient physiological parameter.

25. The method of claim 24, wherein the control system is further programmed to activate, deactivate or otherwise modulate the baroreflex therapy system to deliver a baroreflex therapy via the baroreflex activation device based on the comparison of the patient physiological parameter to the blood pressure measurement.

26. The method of claim 25, wherein the control system contains pre-determined ranges for each of blood pressure, heart rate and arterial stiffness, the method further comprising:

delivering a first therapy when the patient physiological parameter and the blood pressure measurement are each within the pre-determined ranges; and

delivering a second therapy when the patient physiological parameter and the blood pressure measurement each exceed the pre-determined ranges.

27. The method of claim 25, wherein the control system contains pre-determined ranges for each of blood pressure, heart rate and arterial stiffness, the method further comprising:

delivering a first therapy when the patient physiological parameter is within the predetermined range and the blood pressure measurement exceeds the pre-determined range; and

delivering a second therapy when the patient physiological parameter and the blood pressure measurement each exceed the pre-determined ranges.

28. The method of claim 24, further comprising:

implanting the baroreflex activation device such that the therapy electrode is in contact with a wall of the blood vessel; and

implanting the measurement device such that the measurement electrode is in contact with the wall of the blood vessel and proximate the therapy electrode.

29. The method of claim 24, further comprising implanting at least one of the baroreflex therapy system and the measurement device proximate a blood vessel of a patient selected from the group consisting of:

a carotid sinus, an aortic arch, a common carotid artery, a subclavian artery, a brachiocephalic artery, pulmonary artery, pulmonary vein, jugular vein, femoral artery, femoral vein, and a heart.