Methods for controlling a left ventricular assist device

Patent metadata

Field	Value
Publication number	US-11517740-B2
Application number	US-201916354922-A
Country	US
Kind code	B2
Filing date	Mar 15, 2019
Priority date	Mar 15, 2018
Publication date	Dec 6, 2022
Grant date	Dec 6, 2022

Abstract

The present invention is generally related to methods and systems for preventing onset or worsening of RHF in patients with implanted ventricular assist devices. More particularly, the present invention relates to identifying patients at risk for RHF following implantation of a ventricular assist device based on pulmonary artery pressure measurement and/or trends and adjusting a pump operating parameter to prevent or reduce the onset or worsening of RHF in such patients, improve patient outcomes, or reduce mortality risks associated with VAD implantation. In particular, a pump operating parameter may be adjusted to reduce or minimize particularly high pressure loads on a patient's heart or amount of time the patient is exposed to such high pressure loads following implantation.

First claim

What is claimed is:

1. A method of controlling operation of a left ventricular assist device (LVAD) to reduce risk of right heart failure (RHF) in a patient following implantation of the LVAD, the method comprising:
controlling operation of the LVAD that is implanted in the patient to pump blood from the patient's left ventricle to the patient's aorta;
generating pulmonary artery (PA) pressure trending data for the patient via measuring pulmonary artery (PA) pressures of the patient including during the operation of the LVAD, wherein the PA pressure trending data for the patient is indicative of a variation of right ventricular afterload of the patient over a time span;
determining a regression model for the PA pressure trending data for the patient;
using the regression model to compute an estimated parameter value;
determining a deviation between the estimated parameter value and an ideal parameter value for the patient, wherein the ideal parameter for the patient is indicative of an ideal right ventricular afterload for the patient; and
controlling operation of the LVAD to adjust at least one operating parameter of the LVAD based on the deviation between the estimated parameter value and the ideal parameter value so as to reduce a deviation between the right ventricular afterload of the patient and the ideal right ventricular afterload for the patient.

2. The method of claim 1 , further comprising determining a goodness of fit of the regression model of the PA pressure trending data for the patient prior to determining the deviation between the estimated parameter value and the ideal parameter value.

3. The method of claim 2 , further comprising measuring additional PA pressures of the patient including during the operation of the LVAD in response to the goodness of fit being inadequate relative to an acceptable goodness of fit, and wherein the regression model is determined so as to account for the additional PA pressures of the patient.

4. The method of claim 1 , wherein the PA pressures of the patient are measured only during a transient period of time following implantation of the LVAD.

5. The method of claim 4 , wherein the transient period of time lasts for less than about 20 days following implantation of the LVAD prior to transitioning to a stable or steady state period.

6. The method of claim 1 , wherein determining the deviation between the estimated parameter value and the ideal parameter value comprises computing a deviation between an estimated steady state PA pressure of the patient and an ideal steady state PA pressure for the patient, wherein the estimate steady state PA pressure of the patient is indicative of an estimated right ventricular afterload of the patient, and wherein the ideal stead state PA pressure for the patient is indicative of the ideal right ventricular afterload for the patient.

7. The method of claim 6 , wherein the controlling operation of the LVAD to adjust at least one operating parameter of the LVAD comprises increasing a flow rate of the LVAD in response to the estimated steady state PA pressure of the patient being greater than the ideal steady state PA pressure for the patient by at least an upper threshold pressure deviation value.

8. The method of claim 6 , wherein the controlling operation of the LVAD to adjust at least one operating parameter of the LVAD comprises decreasing a flow rate of the LVAD in response to the estimated steady state PA pressure of the patient being less than the ideal steady state PA pressure for the patient by at least a lower threshold pressure deviation value.

9. The method of claim 1 , wherein the controlling operation of the LVAD to adjust at least one operating parameter of the LVAD comprises adjusting at least one of a flow rate of the LVAD, a pump speed of the LVAD, or a pumping operation mode of the LVAD.

10. The method of claim 9 , wherein the controlling operation of the LVAD to adjust at least one operating parameter of the LVAD comprises adjusting the pumping operation mode of the LVAD.

11. The method of claim 1 , wherein the regression model is defined by: p(t)=p ∞ +e −αt (p 0 −p ∞ ), wherein:
p(t) are the measured PA pressures of the patient over the time span;
p 0 is estimated baseline PA pressure of the patient prior to implantation of the LVAD in the patient;
p ∞ is estimated steady state PA pressure; and
α is an estimated time constant.

12. The method of claim 1 , wherein the measured PA pressures of the patient are wirelessly transmitted by pressure sensor implanted within the pulmonary artery or an interrogation unit associated with the pressure sensor.

13. The method of claim 1 , further comprising determining a responsiveness of the patient to the LVAD based on the determined deviation prior to the controlling operation of the LVAD to adjust the at least one operating parameter of the LVAD.

14. The method of claim 1 , wherein each of the estimated parameter value and the ideal parameter value comprise a respective time parameter value.

15. The method of claim 1 , wherein at least one of an external heart blood pump controller, an implantable heart blood pump controller, or an external computing device perform the method.

16. The method of claim 1 , wherein the controlling of the LVAD to adjust the at least one operating parameter of the LVAD stabilizes PA pressures of the patient within a desired range for a stabilization period following a transient period.

17. The method of claim 1 , further comprising outputting at least one of a visual, audio, or haptic alert prior to the controlling of the LVAD to adjust the at least one operation parameter of the LVAD.

18. The method of claim 1 , wherein the PA pressure trending data for the patient comprises PA mean pressures for the patient.

Assignees

• Tc1 Llc

Inventors

• Agarwal Rahul
• Connolly Allison
• Nabutovsky Yelena
• Prillinger Julie

Classifications

• A61M2230/30

  Blood pressure (A61M2230/04 takes precedence) · CPC title

• A61M60/232

  Centrifugal pumps · CPC title

• A61M2205/583

  by visual feedback · CPC title

• A61B5/7455

  characterised by tactile indication, e.g. vibration or electrical stimulation · CPC title

• A61M60/88 Primary

  Percutaneous cables · CPC title