Cardiac modulation facilitation methods and systems

• US 10,493,278 B2
• Filed: 01/04/2016
• Issued: 12/03/2019
• Est. Priority Date: 01/05/2015
• Status: Active Grant

• Current Assignee: Cardionomic, Inc.
• Original Assignee: Cardionomic, Inc.
• Inventors: Waldhauser, Steven L., Goedeke, Steven D.
• Primary Examiner(s): Malamud, Deborah L
• Application Number:
  US15/540,161
• Publication Number:
  US 20180050206A1
• Time in Patent Office: 1,429 Days
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2562/0219 Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
• CPC Class Codes: A61B 5/01 Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue clinical contact thermometers G01K13/20
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/25 Bioelectric electrodes therefor
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/6869 Heart
• CPC Class Codes: A61B 7/023 for introduction into the body, e.g. into the oesophagus oesophageal ECG probes A61B5/285
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/36114 Cardiac control, e.g. by vagal stimulation stimulating the heart A61N1/362
• CPC Class Codes: A61N 1/36139 with automatic adjustment

Abstract

A method of facilitating therapeutic neuromodulation of a heart of a patient includes positioning an electrode in a pulmonary artery, positioning a sensor in vasculature, delivering via a stimulation system first and second electrical signals of a series of electrical signals to the electrode. The second electrical signal differs from the first electrical signal by a magnitude of a first parameter of a plurality of parameters. The method includes determining, via the sensor, sensor data indicative of one or more heart activity properties in response to the delivery of the series of electrical signals, and delivering a therapeutic neuromodulation signal to the pulmonary artery using selected electrical parameters. The selected electrical parameters include a selected magnitude of the first parameter. The selected magnitude of the first parameter is based at least partially on the sensor data. The therapeutic neuromodulation signal increases heart contractility.

Claims

1. A method of facilitating therapeutic neuromodulation of a heart of a patient, the method comprising:

delivering a first series of electrical signals to an electrode in a first anatomical location,

the first series comprising a first plurality of electrical signals,

each of the first plurality of electrical signals comprising a plurality of parameters,

each of the first plurality of electrical signals of the first series only differing from one another by a magnitude of a first parameter of the plurality of parameters;

after delivering the first series of electrical signals to the electrode, delivering a second series of electrical signals to the electrode,

the second series comprising a second plurality of electrical signals,

each of the second plurality of electrical signals comprising the plurality of parameters,

each of the second plurality of electrical signals of the second series only differing from one another by a magnitude of a second parameter of the plurality of parameters,

the second parameter different than the first parameter;

sensing, via a sensor in a second anatomical location different than the first anatomical location, sensor data indicative of one or more non-electrical heart activity properties in response to delivering the first series of electrical signals and the second series of electrical signals; and

providing a therapeutic neuromodulation signal to the first anatomical location using selected electrical parameters,

wherein the selected electrical parameters comprise a selected magnitude of the first parameter and a selected magnitude of the second parameter,

wherein the selected magnitudes of the first and second parameters are based at least partially on the sensor data, and

wherein the therapeutic neuromodulation signal increases heart contractility.

2. The method of claim 1, wherein the first parameter comprises current and the second parameter comprises one of frequency and duty cycle.

3. The method of claim 1, further comprising:

delivering a third series of electrical signals to the electrode,

the third series comprising a third plurality of electrical signals,

each of the third plurality of electrical signals comprising the plurality of parameters,

each of the third plurality of electrical signals of the third series only differing from one another by a magnitude of a third parameter of the plurality of parameters,

the third parameter different than the first parameter and the second parameter,

sensing, via the sensor, sensor data indicative of the one or more non-electrical heart activity properties in response to delivering the third series of electrical signals,

wherein the selected electrical parameters comprise a selected magnitude of the third parameter,

wherein the selected magnitude of the third parameter is based at least partially on the sensor data.

4. The method of claim 3,

wherein delivering the first series of electrical signals to the electrode is via a stimulation system,

wherein delivering the second series of electrical signals to the electrode is via the stimulation system, and

wherein delivering the third series of electrical signals to the electrode is via the stimulation system.

5. The method of claim 1, further comprising determining a desired hierarchy between the first series and the second series.

6. The method of claim 1, wherein the first anatomical location comprises a right pulmonary artery.

7. The method of claim 1, wherein the one or more non-electrical heart activity properties comprises at least one of a pressure property, an acceleration property, an acoustic property, a temperature, and a blood chemistry property.

8. The method of claim 1, wherein sensing the sensor data comprises determining, via a second sensor on a skin surface, sensor data indicative of an electrocardiogram property in response to delivering the first series of electrical signals and the second series of electrical signals.

9. The method of claim 1, wherein the first parameter is one of the following:

a polarity, a pulsing mode, a pulse width, an amplitude, a frequency, a phase, a voltage, a current, a duration, an inter-pulse interval, a duty cycle, a dwell time, a sequence, a wavelength, or a waveform.

10. The method of claim 9, wherein the second parameter is a different one of the following:

a polarity, a pulsing mode, a pulse width, an amplitude, a frequency, a phase, a voltage, a current, a duration, an inter-pulse interval, a duty cycle, a dwell time, a sequence, a wavelength, or a waveform.

11. The method of claim 1, wherein the second parameter is one of the following:

a polarity, a pulsing mode, a pulse width, an amplitude, a frequency, a phase, a voltage, a current, a duration, an inter-pulse interval, a duty cycle, a dwell time, a sequence, a wavelength, or a waveform.

12. The method of claim 1, further comprising:

positioning the electrode in a pulmonary artery of a heart; and

positioning the sensor in a right ventricle of the heart;

wherein delivering the first series of electrical signals to the electrode is via a stimulation system,

wherein delivering the second series of electrical signals to the electrode is via the stimulation system.

13. The method of claim 1, wherein the first anatomical location comprises a pulmonary artery.

14. The method of claim 1, wherein the one or more non-electrical heart activity properties comprises a pressure property.

15. The method of claim 1, wherein the first parameter is one of the following:

a pulse width, an amplitude, or a frequency.

16. The method of claim 15, wherein the second parameter is a different one of the following:

a pulse width, an amplitude, or a frequency.

17. The method of claim 1, wherein the second parameter is one of the following:

a pulse width, an amplitude, or a frequency.

18. The method of claim 1, further comprising:

positioning a catheter including the electrode so the first anatomical position is in a pulmonary artery of a heart; and

positioning the sensor so the second anatomical position is in a location within vasculature of the heart.

19. The method of claim 1, wherein the one or more non-electrical heart activity properties includes an acceleration property.

20. The method of claim 1, wherein the first parameter is one of the following:

a pulse width, an amplitude, a frequency, or a duty cycle.

21. The method of claim 20, wherein the second parameter is a different one of the following:

a pulse width, an amplitude, a frequency, or a duty cycle.

22. The method of claim 1, wherein the one or more non-electrical heart activity properties includes a temperature.

23. The method of claim 1, wherein the first parameter is one of the following:

a pulse width, an amplitude, a frequency, or a waveform.

24. The method of claim 23, wherein the second parameter is a different one of the following:

a pulse width, an amplitude, a frequency or a waveform.

25. The method of claim 1, wherein the one or more non-electrical heart activity properties includes a blood chemistry property.