System for setting programmable parameters for an implantable hypertension treatment device
First Claim
1. A system for setting programmable parameters for an implantable baroreflex stimulation device, comprising:
- an implantable baroreflex stimulation 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 baroreflex stimulation 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;
cause the implantable baroreflex stimulation 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;
program the implantable baroreflex stimulation 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.
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Accused Products
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.
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Citations
20 Claims
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1. A system for setting programmable parameters for an implantable baroreflex stimulation device, comprising:
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an implantable baroreflex stimulation 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 baroreflex stimulation 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; cause the implantable baroreflex stimulation 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; program the implantable baroreflex stimulation 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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A method of establishing programmable parameters for an implantable baroreflex stimulation device in a patient comprising:
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providing a programming system that is configured to perform the steps of; causing the implantable baroreflex stimulation 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; monitoring information representing a hemodynamic response of the patient over a monitoring time duration for each of the plurality of electrotherapy doses; and establishing a patient-specific electrotherapy dose response relationship between the electrotherapy dose and the hemodynamic response; using the programming system to program the implantable baroreflex stimulation 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. - View Dependent Claims (12, 13, 14, 15, 16, 17, 18)
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19. A method, comprising:
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causing an implantable baroreflex stimulation device to be manufactured and made available to a user, the implantable baroreflex stimulation 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; causing a programming system to be manufactured and made available to a user, the programming system communicatively interfaced with the implantable baroreflex stimulation device and with a hemodynamic monitoring system configured to collect information representing a hemodynamic response of the patient over a monitoring time duration; and providing instructions recorded on a tangible medium to the user, the instructions for setting programmable parameters for the implantable baroreflex stimulation device, the instructions comprising; initiating 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 selectively processing the information representing the hemodynamic response of the patient for the monitoring time duration for each electrotherapy dose; establishing a patient-specific electrotherapy dose response relationship between the electrotherapy dose and the hemodynamic response of the patient; and programming the implantable baroreflex stimulation 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.
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20. A method, comprising:
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providing an implantable baroreflex stimulation device to a user, the implantable baroreflex stimulation 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; providing a programming system to a user, the programming system communicatively interfaced with the implantable baroreflex stimulation device and with a hemodynamic monitoring system configured to collect information representing a hemodynamic response of the patient over a monitoring time duration; and programming the control system with instructions recorded on a tangible medium for operating the implantable baroreflex stimulation device, the instructions comprising; initiating 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 selectively processing the information representing the hemodynamic response of the patient for the monitoring time duration for each electrotherapy dose; establishing a patient-specific electrotherapy dose response relationship between the electrotherapy dose and the hemodynamic response of the patient; and programming the implantable baroreflex stimulation 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.
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Specification