EP-4742262-A1 - SAFETY MONITOR FOR HEART-LUNG MACHINE AND ASSOCIATED METHODS

EP4742262A1EP 4742262 A1EP4742262 A1EP 4742262A1EP-4742262-A1

Abstract

The present disclosure includes a system monitor and associated methods for a heart-lung machine (HLM) and/or other like device. Example system monitors may include a profile module adapted to accept user parameters and receive settings changes from a remote interface, and provide updated user parameters to a safety module based upon received settings changes. The system monitors of the present disclosure may include a subsystem module in communication with one or more subsystems. The subsystem module may be adapted to periodically scan subsystem data from the one or more subsystems and provide actual user parameters to the safety module from the scanned subsystem data. The safety module of the present disclosure may be configured to compare the updated user parameters to the actual user parameters, and correct the actual user parameters to match the updated user parameters.

Inventors

BAUER, HERMANN
SCHUBERT, Friedemann

Assignees

LivaNova Deutschland GmbH

Dates

Publication Date: 20260513
Application Date: 20251023

Claims (15)

A system monitor for a heart-lung machine (HLM), comprising: a profile module configured to accept user parameters and receive settings changes from a remote interface, and provide updated user parameters to a safety module based upon received settings changes; and a subsystem module in communication with one or more subsystems, the subsystem module configured to periodically scan subsystem data from the one or more subsystems and provide actual user parameters to the safety module from the scanned subsystem data; wherein the safety module is configured to compare the updated user parameters to the actual user parameters, and correct the actual user parameters to match the updated user parameters.
The system monitor of claim 1, wherein the safety module triggers one or more of an alarm and an alert if the actual user parameters cannot match the updated user parameters.
The system monitor of claim 1 or 2, wherein the safety module is configured to perform one or more cyclic redundancy checks (CRC) upon the profile module.
The system monitor of any one of the preceding claims, wherein the one or more user parameters are one or more of: pump settings, motor settings, flow settings, user settings, pressure settings, connection settings, physiological settings, device settings, treatment settings, and procedural settings.
The system monitor of any one of the preceding claims, wherein the one or more discrepancies are one or more of: a mismatch in pump settings, a mismatch in motor settings, a mismatch in flow settings, a mismatch in user settings, a mismatch in pressure settings, a mismatch in connection settings, a mismatch in physiological settings, a mismatch in device settings, a mismatch in treatment settings, and a mismatch in procedural settings.
Computer-executable instructions for correcting a user profile and/or role-change discrepancy in a heart-lung machine (HLM), the computer-executable instructions including: a safety monitor configured to monitor one or more subsystem parameters defined in a profile and/or role change of a user of a heart-lung machine; the safety monitor further configured to: compare the one or more subsystem parameters to one or more previous subsystem parameters defined in a previous profile and/or role change of the user; detect one or more discrepancies in the one or more subsystem parameters with respect to the one or more previous subsystem parameters; and: correct the one of more subsystem parameters having a detected discrepancy to a correct value.
The computer-executable instructions of claim 6, wherein the safety monitor triggers one or more of an alarm and an alert if the one or more discrepancies are unable to be corrected to a correct value.
The computer-executable instructions of claim 6 or 7, wherein the safety monitor performs one or more cyclic redundancy checks (CRC) to compare the one or more subsystem parameters to the one or more previous subsystem parameters.
The computer-executable instructions of any one of claims 6 to 8, wherein the one or more subsystem parameters are one or more of: pump settings, motor settings, flow settings, user settings, pressure settings, connection settings, physiological settings, device settings, treatment settings, and procedural settings.
The computer-executable instructions of any one of claims 6 to 9, wherein the one or more discrepancies are one or more of: a mismatch in pump settings, a mismatch in motor settings, a mismatch in flow settings, a mismatch in user settings, a mismatch in pressure settings, a mismatch in connection settings, a mismatch in physiological settings, a mismatch in device settings, a mismatch in treatment settings, and a mismatch in procedural settings.
A computer-implemented method for automatically correcting a user profile and/or role-change discrepancy in a heart-lung machine (HLM), the method comprising: monitoring one or more subsystem parameters defined in a profile and/or role change of a user of a heart-lung machine; comparing the one or more subsystem parameters to one or more previous subsystem parameters defined in a previous profile and/or role change of the user; detecting one or more discrepancies in the one or more subsystem parameters with respect to the one or more previous subsystem parameters; correcting the one or more discrepancies in the one or more subsystem parameters such that the one or more subsystem parameters are configured accurately.
The method of claim 11, further including: periodically checking the one or more subsystem parameters and confirming that the one or more subsystem parameters are configured accurately and/or present.
The method of claim 11 or 12, wherein the safety monitor system is configured to alert the user with an alarm if the one or more discrepancies cannot be corrected.
The method of any one of claims 11 to 13, wherein the one or more subsystem parameters are one or more of: pump settings, motor settings, flow settings, user settings, pressure settings, connection settings, physiological settings, device settings, treatment settings, and procedural settings.
The method of any one of claims 11 to 14, wherein the one or more discrepancies are one or more of: a mismatch in pump settings, a mismatch in motor settings, a mismatch in flow settings, a mismatch in user settings, a mismatch in pressure settings, a mismatch in connection settings, a mismatch in physiological settings, a mismatch in device settings, a mismatch in treatment settings, and a mismatch in procedural settings.

Description

TECHNICAL FIELD The present disclosure relates to the field of medical devices and associated medical systems. More particularly, the present disclosure relates to operative characteristics, designs, devices, methods of use, and methods of utilization for heart-lung machines, related components and other like devices. BACKGROUND Heart-lung machine ("HLM") systems are used, along with an extracorporeal circuit and a hollow fiber oxygenator, to meet a patient's circulatory and blood gas exchange needs during medical procedures such as cardiopulmonary bypass ("CPB") surgery. Blood from the patient is either gravity drained, or VAVD (vacuum assisted venous drainage) is used, to obtain the desired amount of blood flow through the extracorporeal circuit. A pump, such as a peristaltic pump or a centrifugal pump, may be used in the extracorporeal circuit in order to pump blood from the patient, to the reservoir, through the oxygenator, and finally back to the patient. In addition to an HLM per se, heart-lung machine systems can include multiple types of patient monitoring devices that are used in conjunction with the HLM. BRIEF SUMMARY During routine operation of a heart-lung machine or other like device, a user and/or practitioner inputs a user profile (i.e., profile) including user settings, and various operational settings related to the control assemblies of a heart-lung machine to ensure safe and effective operation of the heart-lung machine and all peripheral and like components related to the operation of the heart-lung machine and/or other like device(s). Certain heart-lung machines, however, are unable to automatically update operating parameters in response to a change in user and/or operational settings, and this can be problematic as it results in inaccurate, ineffective, and deleterious assessment of a user of a heart-lung machine and/or other like device which therefore may result in inaccurate, ineffective and deleterious treatment of the user. In other words, if accurate user settings and/or operational settings are not ensured automatically, and/or not immediately corrected by a human operator, the heart-lung machine and/or other like and/or connected components will not function properly, will not deliver accurate therapy to a user, and may result in dangerous and/or deleterious consequences for a user of a heart-lung machine and/or related device due to inaccuracy and/or faulty operation of the heart-lung machine and/or other like devices and/or other related components and/or devices. The present disclosure provides a system monitor in addition to various other features that provide automatic correction of the user and/or operational settings of a heart-lung machine and/or other like device and/or other devices and/or components related to the use of a heart-lung machine and/or other like devices and/or systems. An example system monitor of the present disclosure may include a profile module adapted and/or otherwise configured to accept user parameters and receive settings changes from a remote interface. The profile module of this and other examples may also provide updated user parameters to a safety module based upon received settings changes. The system monitor of this and other examples may include a subsystem module in communication with one or more subsystems. The subsystem module may be adapted and/or otherwise configured to periodically scan subsystem data from the one or more subsystems and provide actual user parameters to the safety module from the scanned subsystem data. In this and other examples, the safety module may be adapted and/or otherwise configured to compare the updated user parameters to the actual user parameters, and may correct the actual user parameters to match the updated user parameters. Alternatively or additionally to any of the examples disclosed herein, the safety module may trigger one or more of an alarm and an alert if the actual parameters cannot match the updated user parameters. Alternatively or additionally to any of the examples disclosed herein, the safety module may be adapted and/or otherwise configured to perform one or more cyclic redundancy checks (CRC) upon the profile module. Alternatively or additionally to any of the examples disclosed herein, the one or more user parameters may be one or more of: pump settings, motor settings, flow settings, user settings, pressure settings, connection settings, physiological settings, device settings, treatment settings, and procedural settings. Alternatively or additionally to any of the examples disclosed herein, computer-executable instructions for correcting a user profile and/or role-change discrepancy in a heart-lung machine (HLM) are provided by the disclosure herein. An example provision of computer-executable instructions may include a safety monitor configured to monitor one or more subsystem parameters defined in a profile and/or role change of a user of a heart-lung machine. The safety monitor o