Methods of monitoring effects of neurostimulation

• US 10,188,343 B2
• Filed: 02/08/2018
• Issued: 01/29/2019
• Est. Priority Date: 03/09/2016
• Status: Active Grant

• Current Assignee: Cardionomic, Inc.
• Original Assignee: Cardionomic, Inc.
• Inventors: Goedeke, Steven D., Christopherson, Mark A., Serdar, David J., Christian, Steven C.
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US15/892,199
• Publication Number:
  US 20180169414A1
• Time in Patent Office: 355 Days
• Field of Search: None
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• CPC Class Codes: A61B 2018/00279 deployable
• CPC Class Codes: A61B 2018/00285 Balloons
• CPC Class Codes: A61B 2018/00351 Heart
• CPC Class Codes: A61B 2018/00839 Bioelectrical parameters, e.g. ECG, EEG
• CPC Class Codes: A61B 2562/0247 Pressure sensors
• CPC Class Codes: A61B 2562/028 Microscale sensors, e.g. electromechanical sensors [MEMS]
• CPC Class Codes: A61B 5/02028 Determining haemodynamic parameters not otherwise provided for, e.g. cardiac contractility or left ventricular ejection fraction
• CPC Class Codes: A61B 5/02158 provided with two or more sensor elements
• CPC Class Codes: A61B 5/0823 Detecting or evaluating cough events
• CPC Class Codes: A61B 5/287 Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
• CPC Class Codes: A61B 5/349 Detecting specific parameters of the electrocardiograph cycle
• CPC Class Codes: A61B 5/4836 Diagnosis combined with treatment in closed-loop systems or methods A61B5/0036 takes precedence
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/6858 with a distal basket, e.g. expandable basket
• CPC Class Codes: A61B 5/6859 with multiple distal splines
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61B 6/487 : involving fluoroscopy
• CPC Class Codes: A61M 2025/0003 : having an additional lumen transmitting fluid pressure to the outside for measurement
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61N 1/0558 : Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/056 : Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/0573 : chacterised by means penetrating the heart tissue, e.g. helix needle or hook
• CPC Class Codes: A61N 1/36017 : with leads or electrodes penetrating the skin
• 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 1/36135 : using physiological parameters
• CPC Class Codes: A61N 1/36139 : with automatic adjustment
• CPC Class Codes: A61N 1/36146 : specified by the stimulation parameters
• CPC Class Codes: A61N 1/36185 : Selection of the electrode configuration
• CPC Class Codes: A61N 1/3627 : for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
• CPC Class Codes: A61N 1/36585 : controlled by two or more physical parameters
• CPC Class Codes: A61N 2001/058 : Fixing tools

Abstract

A device includes a handle, an expandable structure including a plurality of splines extending from a proximal hub to a distal hub, a first electrode on a first spline of the plurality of splines, an outer tube extending from the handle to the proximal hub, and a shaft extending through the outer tube from the handle to the distal hub. The expandable structure has a collapsed state and a self-expanded state. The handle is configured to retract the shaft. Retracting the shaft may expand the expandable structure outward of the self-expanded state.

Claims

1. A method of monitoring effect of neurostimulation on left ventricle contractility, the method comprising:

positioning a neurostimulator in a pulmonary artery;

positioning a plurality of pressure sensors in a right ventricle;

activating the neurostimulator to apply neurostimulation to a nerve proximate to a pulmonary artery, wherein the neurostimulation increases contractility of the left ventricle;

measuring contractility of the right ventricle using the plurality of pressure sensors;

determining contractility of the left ventricle based on the measured contractility of the right ventricle;

monitoring the effect of the neurostimulation on the left ventricle contractility based on the measured contractility of the right ventricle; and

using closed loop control to alter the neurostimulation.

2. The method claim 1, wherein the plurality of pressure sensors comprises a MEMS sensor.

3. The method claim 1, wherein the plurality of pressure sensors comprises a fluid-filled lumen comprising a first end in communication with an aperture in the right ventricle and a second end in communication with an external pressure sensor.

4. The method claim 1, wherein a catheter comprises the neurostimulator and wherein at least one of the plurality of pressure sensors is integrated in the catheter.

5. The method claim 1, wherein using closed loop control comprises adjusting a parameter of the neurostimulation.

6. The method claim 1, wherein using closed loop control comprises turning the neurostimulation on and off.

7. The method claim 1, wherein the plurality of pressure sensors comprises a first pressure sensor comprising a MEMS sensor and a second pressure sensor comprising a fluid-filled lumen comprising a first end in communication with an aperture in the right ventricle and a second end in communication with an external pressure sensor.

8. The method claim 7, wherein measuring the contractility of the right ventricle comprises taking an average or a weighted average of measurements from the plurality of pressure sensors.

9. A method of monitoring effect of neurostimulation on left ventricle contractility, the method comprising:

positioning a neurostimulator in a pulmonary artery;

positioning a pressure sensor in a right ventricle;

measuring contractility of the right ventricle; and

applying neurostimulation to the neurostimulator;

measuring contractility of the right ventricle using the plurality of pressure sensors;

determining contractility of the left ventricle based on the measured contractility of the right ventricle; and

monitoring the effect of the neurostimulation on the left ventricle contractility based on the measured contractility of the right ventricle.

10. The method claim 9, wherein the pressure sensor comprises a MEMS sensor or a fluid-filled lumen comprising a first end in communication with an aperture in the right ventricle and a second end in communication with an external pressure sensor.

11. The method claim 9, wherein a catheter comprises the neurostimulator and wherein the pressure sensor is integrated in the catheter, and wherein the method further comprises using closed loop control to affect the neurostimulation, wherein using closed loop control comprises at least one of adjusting a parameter of the neurostimulation or turning the neurostimulation on and off.

12. A method of monitoring effect of neurostimulation on left ventricle contractility, the method comprising:

using a pressure sensor in a right ventricle, measuring contractility of the right ventricle; and

correlating the contractility of the right ventricle to contractility of the left ventricle;

determining the left ventricle contractility based on the correlation; and

monitoring effect of neurostimulaton based on the determined left ventricle contractility.

13. The method claim 12, wherein the pressure sensor comprises a MEMS sensor or a fluid-filled lumen comprising a first end in communication with an aperture in the right ventricle and a second end in communication with an external pressure sensor.

14. The method claim 12, wherein a catheter comprises the neurostimulator and wherein the pressure sensor is integrated in the catheter.

15. The method of claim 12, further comprising using closed loop control to affect the neurostimulation, wherein using closed loop control comprises at least one of adjusting a parameter of the neurostimulation or turning the neurostimulation on and off.

16. The method of claim 12, further comprising:

positioning a neurostimulator in a pulmonary artery;

applying neurostimulation to the neurostimulator; and

determining the effect of the neurostimulation on the left ventricle contractility.

17. The method claim 16, wherein measuring the contractility of the right ventricle is before applying the neurostimulation.

18. The method claim 16, wherein measuring the contractility of the right ventricle is during applying the neurostimulation.

19. The method claim 16, wherein measuring the contractility of the right ventricle is after applying the neurostimulation.

20. The method claim 16, wherein the pressure sensor comprises a first pressure sensor comprising a MEMS sensor and a second pressure sensor comprising a fluid-filled lumen comprising a first end in communication with an aperture in the right ventricle and a second end in communication with an external pressure sensor, wherein measuring the contractility of the right ventricle comprises taking an average or a weighted average of measurements from the first and second pressure sensors.