System for setting programmable parameters for an implantable hypertension treatment device

• US 8,712,522 B1
• Filed: 10/18/2005
• Issued: 04/29/2014
• Est. Priority Date: 10/18/2005
• Status: Active Grant

• Current Assignee: CVRx, Inc.
• Original Assignee: CVRx, Inc.
• Inventors: Rossing, Martin A.
• Primary Examiner(s): Porter, Jr., Allen
• Application Number:
  US11/254,042
• Time in Patent Office: 3,115 Days
• Field of Search: 607/2, 607/4, 607/5, 607/9, 607/30, 607/32, 607/44, 607/60, 607/23, 128/899, 128/903
• US Class Current: 607/23
• 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: A61N 1/36139 with automatic adjustment
• CPC Class Codes: A61N 1/37 Monitoring; Protecting
• CPC Class Codes: A61N 1/37247 User interfaces, e.g. input or presentation means

Abstract

A real time, heart rate monitor and a hemodynamic monitoring system are operably integrated with the programmer system for an implantable hypertension treatment device. A series of tests are automatically performed to set programmable parameters for the implantable hypertension treatment device without clinician intervention. In one embodiment, a predetermined level of a dose-response evaluation is initiated for each test in the series. Preferably, the programmer system monitors the heart rate to determine whether a hemodynamic measurement should be initiated at all for a given test, as well as whether the hemodynamic measurement should be initiated earlier or later than a predetermined settling period for assessing the sympathetic nervous response to the test dose. In one embodiment, this determination is based on heart rate stability/instability. Alternatively, other indicators of sympathetic/parasympathetic tone, such as heart rate variability, may be used to trigger/delay the timing of the hemodynamic measurement.

Claims

1. A system for setting programmable parameters for an implantable hypertension treatment device in a patient comprising:

an implantable hypertension treatment device including an electrode configured to be implanted on or in a blood vessel proximate one or more baroreceptors in a wall of the blood vessel; and

a programming system communicatively interfaced with the implantable hypertension treatment device and with a hemodynamic monitoring system configured to collect information representing a hemodynamic response of the patient over a monitoring time duration, the programming system being configured to;

automatically cause the implantable hypertension treatment device to initiate an electrotherapy dose-response test, the test including;

delivering a plurality of electrotherapy doses of varying levels to the one or more baroreceptors of the patient via the electrode; and

for each electrotherapy dose, selectively processing the information representing the hemodynamic response of the patient for the monitoring time duration for that electrotherapy dose to establish a patient-specific electrotherapy dose response relationship between the electrotherapy dose and the hemodynamic response of the patient;

automatically program the implantable hypertension treatment device with at least one operating parameter based at least in part on the patient-specific electrotherapy dose-response relationship subsequent to establishing the patient-specific electrotherapy dose-response relationship, wherein the at least one operating parameter is configured to lower a blood pressure of the patient.

2. The system of claim 1, wherein the monitoring time duration during which the hemodynamic monitoring system is configured to collect the information representing the hemodynamic response of the patient is at least one minute.

3. The system of claim 1, wherein the programming system is operatively interfaced with a heart rate monitoring system and the programming system is adapted to automatically monitor information representing a heart rate of the patient from the heart rate monitoring system and provide an alert if the heart rate is outside of an expected range.

4. The system of claim 3, wherein the alert by the programming system to the out-of-range heart rate causes automatic suspension of the delivery of electrotherapy doses.

5. The system of claim 3, wherein the programming system utilizes the information representing at least the heart rate to determine whether to selectively initiate the hemodynamic monitoring system.

6. The system of claim 5, wherein the programming system evaluates at least one of a set of factors in the information representing at least the heart rate consisting of:

heart rate stability, heart rate instability, sympathetic/parasympathetic tone, and heart rate variability, to determine whether to selectively initiate the hemodynamic monitoring system.

7. The system of claim 3, wherein the programming system evaluates the information representing at least the heart rate to determine whether to adjust the monitoring time duration to be greater than or less than a predetermined settling period for assessing a sympathetic nervous response to the electrotherapy dose.

8. The system of claim 7, wherein the programming system evaluates at least one of a set of factors in the information representing at least the heart rate consisting of:

heart rate stability, heart rate instability, sympathetic/parasympathetic tone, and heart rate variability, to determine whether and how much to adjust the monitoring time duration.

9. The system of claim 3, wherein at least one of the hemodynamic monitoring system and the heart rate monitoring system is configured to be implanted in the patient.

10. The system of claim 1, wherein the information representing a hemodynamic response includes at least one hemodynamic information type selected from the set consisting of:

pulse rate information;

systolic pressure information;

diastolic pressure information;

mean arterial pressure information;

pulse pressure information;

oxygenation information;

electrocardiogram information;

cardiovascular resistance; and

sympathetic/parasympathetic tone information.

11. The system of claim 1, wherein the programmer system evaluates the information representing at least the hemodynamic response to determine whether to adjust the monitoring time duration.

12. The system of claim 1, wherein the programming system is further configured to automatically set the at least one operating parameter of the implantable hypertension treatment device based at least in part on the patient-specific electrotherapy dose-response relationship to achieve a desired performance goal based upon consuming a minimal amount of energy of the implantable hypertension treatment device while achieving a desired degree of reduction in blood pressure of the patient.

13. The system of claim 1, wherein the programming system is configured to interface with a hemodynamic monitoring system according to an arrangement selected from the set consisting of:

a separate device in communication with the programmer system, a system incorporated into the programmer system, and a system integrated with the implantable hypertension treatment device.

14. The system of claim 1, wherein the programming system further comprises an operator interface that enables a clinician to observe and adjust operation of the system and to provide input utilized to at least alter how the at least one operating parameter is set.

15. The system of claim 14, wherein the programming system is configured to enable the clinician to provide an input to selectively enable the programming system to advance from one electrotherapy dose to a next electrotherapy dose.

16. The system of claim 14, further comprising data storage memory in operable communication with at least one of the programmer system and the implantable hypertension treatment device, the data storage memory configured to store historical data representing the electrotherapy dose-response relationship.

17. The system of claim 16, wherein the operator interface is configured to display the historical data to the clinician.

18. The system of claim 1, wherein the programming system further comprises a remote control that facilitates remote monitoring of the plurality of electrotherapy doses and hemodynamic responses by the clinician.

19. The system of claim 1, wherein the remote control is configured to permit the remote monitoring by the clinician from outside a room where the patient is located.

20. A method of establishing programmable parameters for an implantable hypertension treatment device in a patient comprising:

providing a programming system that automatically performs the steps of;

causing the implantable hypertension treatment device to initiate an electrotherapy dose-response test, the test including;

delivering a plurality of electrotherapy doses of varying levels to one or more baroreceptors of the patient via an electrode implanted on or in a blood vessel proximate the one or more baroreceptors in a wall of the blood vessel;

for each of the plurality of electrotherapy doses, monitoring information representing a hemodynamic response of the patient over a monitoring time duration; and

establishing a patient-specific electrotherapy dose response relationship between the electrotherapy dose and the hemodynamic response;

using the programming system to automatically program the implantable hypertension treatment device with at least one operating parameter based at least in part on the patient-specific electrotherapy dose-response relationship subsequent to establishing the patient-specific electrotherapy dose-response relationship, wherein the at least one operating parameter is configured to lower a blood pressure of the patient.

21. The method of claim 20, further comprising:

monitoring information representing at least a heart rate of the patient over a testing time duration of at least several minutes and providing an alert if the heart rate is outside an expected range.

22. The method of claim 21, wherein the programming system automatically performs the further step of utilizing the information representing at least the heart rate to determine whether to selectively initiate the step of monitoring the hemodynamic condition.

23. The method of claim 22, wherein the step of utilizing the information representing at least the heart rate to determine whether to selectively initiate the step of monitoring the hemodynamic condition comprises evaluating at least one of a set of factors in the information representing at least the heart rate consisting of:

heart rate stability, heart rate instability, sympathetic/parasympathetic tone, and heart rate variability.

24. The method of claim 21, the programming system automatically performs the further step of evaluating the information representing at least the heart rate to determine whether to adjust the monitoring time duration to be greater than or less than a predetermined settling period for assessing a sympathetic nervous response to the electrotherapy dose.

25. The method of claim 24, wherein the step of evaluating the information representing at least the heart rate to determine whether to adjust the monitoring time duration evaluates at least one of a set of factors in the information representing at least the heart rate consisting of:

heart rate stability, heart rate instability, sympathetic/parasympathetic tone, and heart rate variability.

26. The method of claim 20, wherein the programming system further comprises an operator interface and wherein the step of using the programmable system to set the at least one operating parameter uses the operator interface to permit a clinician to provide input utilized at least to alter how the at least one operating parameter is set.

27. The method of claim 20, further comprising automatically maintaining a record of previously monitored hemodynamic responses and wherein the step of using the programming system to set a programmable operating parameter of the implantable hypertension treatment device to reduce blood pressure is based on the record.

28. The method of claim 20, wherein the information representing a hemodynamic response includes at least one hemodynamic information type selected from the set consisting of:

pulse rate information;

systolic pressure information;

diastolic pressure information;

mean arterial pressure information;

pulse pressure information;

oxygenation information;

electrocardiogram information;

cardiovascular resistance; and

sympathetic/parasympathetic tone information.

29. A method of conducting an electrotherapy dose response test for purposes of setting at least one operating parameter of an implantable hypertension treatment device by using a programming system to automatically perform the steps of:

causing the implantable hypertension treatment device to deliver a first electrotherapy dose to one or more baroreceptors of a patient via an electrode, the electrode being implanted on or in a blood vessel proximate the one or more baroreceptors in a wall of the blood vessel;

monitoring information representing a hemodynamic response of the patient after a settling duration;

repeating these steps for at least a second electrotherapy dose to establish a patient-specific electrotherapy dose-response relationship; and

program at least one operating parameter of the implantable hypertension device based at least in part on the patient-specific electrotherapy dose-response relationship subsequent to establishing the patient-specific electrotherapy relationship, wherein the operating parameter is configured to lower a blood pressure of the patient.