Devices and methods for treatment of heart failure and associated conditions

• US 8,744,586 B2
• Filed: 11/30/2012
• Issued: 06/03/2014
• Est. Priority Date: 06/16/2008
• Status: Active Grant

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Georgakopoulos, Dimitrios, Lovett, Eric Grant, Yared, Nadim
• Primary Examiner(s): Stice, Paula J
• Application Number:
  US13/691,484
• Publication Number:
  US 20130090703A1
• Time in Patent Office: 550 Days
• Field of Search: 607/2, 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 for use of identification, treatment and/or management of heart failure and/or associated conditions. Methods may include providing a baroreflex therapy system, providing an implantable measurement device proximate a blood vessel of a patient, the implantable measurement device including a plurality of electrodes, determining an impedance of the blood vessel with the implantable measurement device over a time period of at least one cardiac cycle, generating at least one signal representative of a pressure waveform based on the impedance, activating, deactivating or otherwise modulating the baroreflex therapy system to deliver a therapy to treat heart failure based at least in part on the at least one signal representative of the pressure waveform.

Claims

1. A system, comprising:

a means for measuring blood pressure of a patient;

a means for measuring heart rate of the patient;

an implantable baroreflex activation device including an electrode, the implantable baroreflex activation device configured to be implanted such that the electrode is in contact with a blood vessel of the patient; and

a control system coupled to the means for measuring blood pressure, the means for measuring heart rate, and the implantable baroreflex activation device, the control system including predetermined ranges for each of blood pressure, heart rate and blood vessel properties, the control system programmed to automatically;

determine an impedance of the blood vessel with the electrode;

determine one or more blood vessel properties based on the impedance of the blood vessel;

determine a blood pressure based on the means for measuring blood pressure;

determine a heart rate based on the means for measuring heart rate; and

activate, deactivate or otherwise modulate the baroreflex activation device to deliver a first baroreflex therapy in response to each of the blood pressure, the heart rate and the blood vessel properties being within the respective predetermined ranges, and deliver a second baroreflex therapy in response to one or more of the blood pressure, the heart rate and the blood vessel properties being outside the respective predetermined ranges.

2. The system of claim 1, wherein the control system includes an implantable pulse generator.

3. The system of claim 1, wherein the means for measuring blood pressure of a patient comprises a sphygmomanometer.

4. The system of claim 1, wherein the means for measuring blood pressure of a patient comprises an implanted blood pressure sensor, and the blood pressure sensor is coupled to the control system.

5. The system of claim 1, wherein the means for measuring heart rate comprises an implanted heart rate sensor, and the heart rate sensor is coupled to the control system.

6. The system of claim 1, wherein the one or more blood vessel properties are related to blood pressure.

7. The system of claim 1, wherein the first baroreflex therapy comprises not delivering a therapy, and wherein the second baroreflex therapy comprises initiating a therapy.

8. The system of claim 1, wherein the second baroreflex therapy is delivered at a level higher than a level of the first baroreflex therapy.

9. The system of claim 1, wherein the baroreflex activation device is configured to be implanted such that the electrode is in contact with a blood vessel of the 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.

10. A method, comprising:

causing a blood pressure measuring means to be manufactured and made available to a user;

causing a heart rate measuring means to be manufactured and made available to the user;

causing an implantable baroreflex activation device to be manufactured and made available to a user, the implantable baroreflex activation device including an electrode, the implantable baroreflex activation device configured to be implanted such that the electrode is in contact with a blood vessel of the patient; and

causing a control system to be manufactured and made available to the user, the control system coupled to the blood pressure measuring means, the heart rate measuring means and the implantable baroreflex activation device, the control system including predetermined ranges for each of blood pressure, heart rate and blood vessel properties, the control system programmed to automatically;

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

determine one or more properties of the blood vessel properties based on the impedance;

receive an indication of blood pressure from the blood pressure sensing means;

receive an indication of heart rate from the heart rate sensing means; and

activate, deactivate or otherwise modulate the baroreflex activation device to deliver a first baroreflex therapy in response to each of the blood pressure, the heart rate and the blood vessel properties being within the respective predetermined ranges, and deliver a second baroreflex therapy in response to one or more of the blood pressure, the heart rate and the blood vessel properties being outside the respective predetermined ranges.

11. The method of claim 10, wherein the first baroreflex therapy comprises not delivering a therapy, and wherein the second baroreflex therapy comprises initiating a therapy.

12. The method of claim 10, wherein the second baroreflex therapy is delivered at a level higher than a level of the first baroreflex therapy.