CHARACTERIZATION AND MODULATION OF PHYSIOLOGIC RESPONSE USING BAROREFLEX ACTIVATION IN CONJUNCTION WITH DRUG THERAPY

• US 20080051767A1
• Filed: 05/21/2007
• Published: 02/28/2008
• Est. Priority Date: 05/19/2006
• Status: Abandoned Application

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Braginsky, Vadim, Kieval, Robert, Pedersen, Brad, Rossing, Martin, Irwin, Eric
• Application Number:
  US11/751,580
• Publication Number:
  US 20080051767A1
• Time in Patent Office: Days
• US Class Current: 604/891.1
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/02405 Determining heart rate variability
• CPC Class Codes: A61B 5/24 Detecting, measuring or recording bioelectric or biomagnetic signals of the body or parts thereof
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/4035 Evaluating the autonomic nervous system
• CPC Class Codes: A61M 2205/3523 using telemetric means
• CPC Class Codes: A61M 2230/30 Blood pressure A61M2230/04 takes precedence
• CPC Class Codes: A61M 5/14276 specially adapted for implantation
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36117 for treating hypertension
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A method and device for delivering and monitoring baroreflex and drug therapy to manage hypertension. The method includes providing an implanted an implanted medical device configured to automatically detect drug-related effects on the autonomic nervous system including the steps of measuring a physiologic status of the autonomic nervous system at desired intervals, logging the physiologic status of the autonomic nervous system at desired intervals, monitoring the measured and logged physiologic status of the autonomic nervous system for any changes and correlating the changes to a corresponding drug administration time. The device includes an implanted baroreflex activation device capable of administering one or more hypertension treatment drugs including a controller that activates and adjusts therapy delivery, a baroreflex activation therapy delivery device, a drug therapy delivery device and a device that senses physiologic parameters.

Claims

1. A method of automatically detecting drug-related effects on the autonomic nervous system comprising:

providing an implanted medical device configured to automatically detect drug-related effects on the autonomic nervous system including the steps of;

measuring a physiologic status of the autonomic nervous system at desired intervals;

logging the physiologic status of the autonomic nervous system at desired intervals;

monitoring the measured and logged physiologic status of the autonomic nervous system for any changes; and

correlating the changes to a corresponding drug administration time.

2. A baroreflex activation device comprising:

a monitor configured to monitor an autonomic nervous system condition; and

a central processing unit configured to correlate the condition to a known effect associated with an introduction or cessation of a hypertension treatment drug.

3. A system for automatically monitoring and detecting drug-related physiology changes comprising:

an implantable device including;

a sensor adapted to sense physiologic changes at desired intervals;

a central processing unit adapted to analyze the physiologic changes and correlate the changes to a drug delivery time.

4. The system of claim 3 further including a baroreflex activation device.

5. The system of claim 3 further including a drug delivery device.

6. A method of treating hypertension by administrating drug therapy in conjunction with baroreflex activation therapy comprising:

implanting a combined drug therapy and baroreflex activation therapy device in a patient;

delivering drug therapy and baroreflex activation therapy to a patient at desired intervals.

7. The method of claim 6 further including measuring physiologic parameters after at least one of the baroreflex and/or drug therapy delivery.

8. The method of claim 7 further including adjusting at least one of the drug and/or baroreflex activation therapy based on the measured physiologic parameters.

9. The method of claim 6 including measuring physiologic parameters at desired intervals.

10. The method of claim 6 further including correlating the measured physiologic parameters to a corresponding delivery time of at least one of the drug and/or baroreflex activation therapy.

11. An implanted baroreflex activation device with means for administering one or more hypertension treatment drugs comprising:

a controller means for activating and adjusting therapy delivery;

a means for delivering baroreflex activation therapy;

a means for delivering drug therapy and

a means for sensing physiologic parameters.

12. A method, comprising:

providing an implantable baroreflex activation device;

providing a sensing arrangement;

providing an implantable drug delivery device;

providing a controller operably communicable with the baroreflex activation device, the sensing arrangement and the drug delivery device; and

providing instructions for operating the device, comprising;

implanting a drug therapy device and a baroreflex activation therapy device in a patient and

delivering drug therapy and baroreflex activation therapy to a patient at desired intervals.

13. A baroreflex therapy system, comprising:

an implantable baroreflex activation device;

a sensing arrangement;

an implantable drug delivery device;

a controller in operable communication with the baroreflex activation device, the sensing arrangement and the drug delivery device; and

instructions recorded on a tangible medium for operating the system, comprising;

measuring a physiologic status of the autonomic nervous system at desired intervals;

logging the physiologic status of the autonomic nervous system at desired intervals;

monitoring the measured and logged physiologic status of the autonomic nervous system for any changes; and

correlating the changes to a corresponding drug administration time.

14. A method, comprising:

providing an implantable baroreflex activation device;

providing an implantable drug delivery device;

providing a sensing arrangement;

providing a controller operably communicable with the baroreflex activation device, the drug delivery device and the sensing arrangement; and

providing instructions for operating the device, comprising;

measuring cardiac electrical activity of a patient with the sensing arrangement to generate cardiac electrical activity data;

communicating the cardiac electrical activity data to the controller;

performing heart rate variability analysis with the controller based on the cardiac electrical activity data; and

providing an indication of the results of the heart rate variability analysis to determine an effect on the autonomic nervous system of a patient, upon which a determination may be made to adjust at least one of the baroreflex therapy and drug therapy to be delivered by at least one of the implantable baroreflex activation device and the drug delivery device.

15. A baroreflex therapy system, comprising:

an implantable baroreflex activation device;

a sensing arrangement;

an implantable drug delivery device;

a controller in operable communication with the baroreflex activation device, the drug delivery device and the sensing arrangement; and

instructions recorded on a tangible medium for operating the device, comprising;

measuring cardiac electrical activity of a patient with the sensing arrangement to generate cardiac electrical activity data;

communicating the cardiac electrical activity data to the controller;

performing heart rate variability analysis with the controller based on the cardiac electrical activity data; and

providing an indication of the heart rate variability analysis upon which a determination may be made to adjust at least one of a baroreflex therapy and drug therapy to be delivered by at least one of the implantable baroreflex activation device and the drug delivery device.