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Method for monitoring physiological cycles of a patient to optimize patient therapy / Cvrx, Inc.




Title: Method for monitoring physiological cycles of a patient to optimize patient therapy.
Abstract: Improved methods for obtaining physiological parameters of a patient in accordance with various embodiments of the present invention can be used to monitor patient status and/or in conjunction with patient therapy. Physiological parameters can be monitored with an implantable device including a first lead and a second lead. Physiological parameters can be measured along at least three distinct vectors defined by the first lead and second lead, the first lead and an electrode located on the device body, and the second lead an the electrode. An output indicative of the physiological parameter can then be provided. Therapy, such as baroreflex therapy, can optionally be optimized based on the physiological measurements. ...


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USPTO Applicaton #: #20120271137
Inventors: Robert S. Kieval


The Patent Description & Claims data below is from USPTO Patent Application 20120271137, Method for monitoring physiological cycles of a patient to optimize patient therapy.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No. 12/347,813, filed Dec. 31, 2008, which claims the benefit of Provisional Patent Application No. 61/018,195, filed Dec. 31, 2007, the disclosures of which are incorporated by reference.

FIELD OF THE INVENTION

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The present invention relates generally to methods for monitoring physiological activity of a patient with an implantable device. More particularly, the present invention relates to detection of physiological parameters of a patient along at least three vectors, which can then be used to optimize patient therapy.

BACKGROUND

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OF THE INVENTION

Electrocardiograms (ECG or EKG) are commonly used to monitor and diagnose heart conditions. An ECG is a recording made by an electrocardiograph of electric waves generated during activity in the heart. To measure an ECG, electrodes, or electrical contacts, are placed on the skin. With each heart beat, an electrical impulse or wave travels through the heart, which in turn, causes the heart muscles to pump blood from the heart to the rest of the body. The ECG records the voltage difference between pairs of electrodes and displays the rhythm of the heart and weaknesses that may be present in different parts of the heart.

In electrocardiography, a “lead” refers to a pair of electrodes that form an imaginary line in a patient along which electrical signals are measured. Three external leads, known as limb leads, form the three legs of what is known in the art as Einthoven's triangle. Einthoven's triangle defines an imaginary equilateral triangle having the heart at its center. Lead I is defined by a vector extending from a negative electrode on the right arm to a positive electrode on the left arm. Lead II is defined by a vector extending from the negative electrode on the right arm to a positive electrode on the left leg. Lead III is defined by a vector extending from a negative electrode on the left arm to the positive electrode on the left leg.

Current implantable cardiac rhythm management devices typically detect cardiac electrical activity between electrodes in or around the heart and the pulse generator, or between two electrodes on the pulse generator. The Reveal® Plus by Medtronic is a subcutaneously implantable loop recorder that can measure and record ECG data. U.S. Pat. No. 5,313,953 by Yomtov et al. discloses an implantable cardiac monitor with a subcutaneous lead proximate the heart, which is designed to process ECG signals. Additionally, prior art pacemaker and defibrillator manufacturers use associated cardiac leads connected to a sense amplifier in implantable pulse generators to facilitate ECG inputs.

Prior art implantable therapy devices such as pacemakers, defibrillators, and other devices have also been used to monitor thoracic impedance to detect respiration-related conditions, such as “lung water” and minute ventilation. This has been accomplished with the use of typically a single electrode implanted within the thoracic cavity, and an implantable pulse generator. While these implantable transthoracic methods of monitoring respiration were sometimes sufficient for diagnostic purposes, their single vector measurement approach leaves room for improvement for monitoring respiration for the purpose of timing the delivery of a therapy.

Significantly, however, cardiac electrical activity occurs over multiple electrical planes and vectors. Typically, approaches used by the prior art to monitor cardiac electrical activity lack complete information because they only detect electrical activity along one vector, such as between an electrode on a cardiac lead and the pulse generator. Furthermore, the prior art does not permit monitoring multiple ECG leads with an implantable medical device and integrating multiple-lead ECG information by an implantable medical device.

Thus, there remains a need in the art to be able to monitor cardiac electrical activity with an implantable medical device that can detect the ECG along at least three vectors, providing more complete information about heart function than existing devices and permitting discrimination of pathological events that cannot be detected with single-vector devices. Additionally, there exists a need in the art for a method for measuring ECGs and analyzing cardiac output that is also capable of detecting a patient's rate of respiration.

SUMMARY

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OF THE INVENTION

Improved methods for obtaining physiological parameters of a patient in accordance with various embodiments of the present invention can be used to monitor patient status and/or in conjunction with patient therapy. Physiological parameters can be monitored with an implantable device including a first lead and a second lead. In one embodiment, the first lead is implanted on the left carotid sinus and the second lead is implanted on the right carotid sinus. Physiological parameters can be measured along at least three distinct vectors defined by a first lead electrode and a second lead electrode, the first lead electrode and an electrode located on the device body, and the second lead an the electrode. Measurement across at least three vectors provides a more complete and accurate reading of patient physiological parameters than measurement across a single vector. An output indicative of the physiological parameter can then be provided. Therapy, such as baroreflex therapy, can optionally be optimized based on the physiological measurements.

In one embodiment, physiological parameters of a patient are monitored with an implantable monitoring system. Monitoring system can include a monitoring device operably connected to a first lead and a second lead. At least one physiological parameter of the patient can be measured by system along at least three distinct vectors. The first vector can be defined by an electrode on the first lead and an electrode on the second lead, the second vector by the electrode on the first lead and an electrode integrated into the monitoring device and the third vector by the electrode on the second lead and the electrode of the monitoring device. An output indicative of the physiological parameter can be provided to the care giver. In one embodiment, the measured parameter is voltage and the output is an ECG of the voltage. In another embodiment, the parameter is impedance and the output represents the patient's respiration. In a further embodiment, an output of the patient's respiration can be provided based on voltage measurements.

In another embodiment, baroreflex therapy can be optimized based on measurements of physiological parameters of a patient. A baroreflex device having an implantable pulse generator operably coupled to a first lead and a second lead can be implanted into the patient. The device can be used to measure at least one physiological parameter of the patient across at least three distinct vectors. The first vector can be defined by the first lead and the second lead, the second vector by the first lead and an electrode integrated into the monitoring device and the third vector by the second lead and the monitoring device. One or more baroreflex therapy pulses can be delivered through the first lead and second lead based on timing determined from the physiological parameter. In one embodiment, the physiological parameter is a voltage reported as an ECG reading, and the therapy pulses are configured to be delivered after a predetermined delay following an R-wave in the ECG. In another embodiment, the physiological parameter is impedance, which is used to determine the patient's respiration cycle, and therapy pulses are delivered during an expiration phase of the patient's respiration. In a further embodiment, both the patient's ECG and respiration are determined and therapy pulses are delivered after a predetermined delay following an R-wave that occurs during an expiration phase of the patient's respiration.

It should be understood that the intention is not to limit the present invention to any particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present invention as defined by the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

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This invention may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which:

FIG. 1 is a schematic illustration of the upper torso of a human body showing the major arteries and veins and associated anatomy.

FIG. 2 is a cross-sectional schematic illustration of the autonomic nervous system.

FIG. 3 is a simplified schematic view of a baroreflex therapy device according to an embodiment of the present invention implanted in a patient.

FIG. 4 is a schematic diagram of a baroreflex modulation therapy system according to an embodiment of the present invention.

FIG. 5 is a graph illustrating a relationship between arterial blood pressure and autonomic nervous system activity.

FIG. 6 is a graph illustrating a method of baroreflex modulation therapy according to an embodiment of the present invention.

FIG. 7 is a graph illustrating a relationship between respiration, parasympathetic nervous system activity and sympathetic nervous system activity.

FIG. 8 is a graph illustrating a method of baroreflex modulation therapy according to an embodiment of the present invention.

FIG. 9 is a schematic diagram of a baroreflex modulation therapy system according to an embodiment of the present invention.

FIG. 10 is a graph illustrating a method of baroreflex modulation therapy according to an embodiment of the present invention.

FIG. 11 is a simplified schematic view of a baroreflex therapy device according to an embodiment of the present invention implanted in a patient.

While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.




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stats Patent Info
Application #
US 20120271137 A1
Publish Date
10/25/2012
Document #
File Date
12/31/1969
USPTO Class
Other USPTO Classes
International Class
/
Drawings
0




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Cvrx, Inc.


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Surgery   Diagnostic Testing   Structure Of Body-contacting Electrode Or Electrode Inserted In Body   Electrode Placed In Body   Electrode Placed In Or On Heart  

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20121025|20120271137|monitoring physiological cycles of a patient to optimize patient therapy|Improved methods for obtaining physiological parameters of a patient in accordance with various embodiments of the present invention can be used to monitor patient status and/or in conjunction with patient therapy. Physiological parameters can be monitored with an implantable device including a first lead and a second lead. Physiological parameters |Cvrx-Inc
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