IP Library Granted Patent US 12,226,253
Granted Patent B2
US 12,226,253 · App. 16/967,929 · Granted Feb 18, 2025

Ultrasound blood-flow monitoring

Inventors: Hans Torp (Trondheim, NO); Torbjørn Hergum (Os, NO)
Assignee: CIMON MEDICAL AS
A61B8/06A61B8/0866A61B8/0883A61B8/4227A61B8/4483A61B8/461A61B8/488A61B8/5207
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Quick Facts
Patent No.
US 12,226,253
App. No.
16/967,929
Granted
Feb 18, 2025
Kind
B2
Abstract

The invention provides a method of monitoring blood flow in a vertebrate animal subject. Unfocussed plane-wave ultrasound pulses are transmitted into the subject, along a transmission axis, from a single-element ultrasound transducer ( 2 ) fastened to the subject ( 5 ). Reflections of the ultrasound pulses are received, generating a succession of pulse-Doppler response signals over time. Each pulse-Doppler response signal is processed to determine a first respective spatial-maximum velocity value for blood flowing towards the single transducer element ( 2 ), and a second respective spatial-maximum velocity value for blood flowing away. Heartbeats are identified from said spatial-maximum velocity values and a quality metric is assigned to each identified heartbeat. A subset of the spatial-maximum velocity values is identified for which the assigned quality metric exceeds a threshold level. The values from the subset are monitored, and, when a set of values from the subset satisfies a predetermined alert criterion an audible or visual alert is signalled.

Claims (38)

1. A method for monitoring a characteristic of blood flow in a vertebrate animal subject, wherein the characteristic of blood flow relates to the velocity of the blood flow and/or wherein the characteristic of blood flow relates to the total blood flow within a region within the subject, the method comprising:

transmitting unfocussed plane-wave ultrasound pulses into the subject from a single-element ultrasound transducer that is fastened to the subject;

receiving reflections of the ultrasound pulses at the single-element ultrasound transducer;

generating a time series of pulse-Doppler response signals from the received reflections;

selecting a depth or depth range at which to monitor the characteristic of blood flow within the subject;

identifying a time-series of one or more heartbeats from the pulse-Doppler response signals from the selected depth or depth range;

evaluating a quality metric for each of the identified one or more heartbeats from the selected depth or depth range, by comparing data associated with successive heartbeats by autocorrelation, to determine a respective quality value associated with each of the identified one or more heartbeats, wherein the quality value associated with each heartbeat depends on a similarity of data derived from the pulse-Doppler response signals for the respective heartbeat, to data derived from the pulse-Doppler response signals for a preceding heartbeat and wherein a higher value of the quality metric indicates a higher confidence that a heartbeat has been identified correctly;

determining a set of valid heartbeats consisting of heartbeats for which the respective quality value exceeds a threshold level;

processing the pulse-Doppler response signals from the selected depth or depth range over a time window to determine values of the characteristic of blood flow within the subject, over time, at the selected depth or depth range for the set of valid heartbeats, comprising excluding from the time window periods of time covering pulse-Doppler response signals for which the identified heartbeats are determined as having a quality value below the threshold level, so as to evaluate the characteristic of blood flow only over those heartbeats for which the associated quality value exceeds the threshold level; and

detecting when one or more of the determined values of the characteristic of blood flow, for the set of valid heartbeats, satisfies a predetermined alert criterion, and, in response, signalling an audible or visual alert.

2. The method of claim 1 , further comprising processing each pulse-Doppler response signal from the selected depth or depth range to determine, from the respective pulse-Doppler response signal, a respective sequence of spatial-maximum velocity values over time for blood flowing through a respective region at the selected depths or depth ranges, wherein the sequences comprise spatial-maximum velocity values for common time periods across the selected depth or depth ranges.

3. The method of claim 1 , wherein selecting the depth or depth range comprises receiving, from a human operator, an input identifying the depth or depth range.

4. The method of claim 1 , wherein selecting the depth or depth range comprises a controller automatically selecting the depth or depth range at which to determine the characteristic of blood flow.

5. The method of claim 1 , wherein the single-element ultrasound transducer is fastened to a skull of the subject, the method comprising transmitting the unfocussed plane-wave ultrasound pulses through a suture or a fontanelle of the skull of the subject.

6. The method of claim 1 , comprising: monitoring the characteristic of blood flow in a neonate or a preterm baby, or in a post-operative patient; or monitoring cerebral circulation; or monitoring microcirculation; or monitoring for sudden blood loss in an emergency setting.

7. The method of claim 1 , wherein comparing data associated with successive heartbeats by autocorrelation comprises comparing successive heartbeats by autocorrelation of the envelope signals.

8. A system for monitoring a characteristic of blood flow in a vertebrate animal subject, wherein the characteristic of blood flow relates to the velocity of the blood flow and/or wherein the characteristic of blood flow relates to the total blood flow within a region within the subject, the system comprising:

a single-element ultrasound transducer for fastening to the subject;

a controller,

wherein the controller is configured to:

control the single-element ultrasound transducer to transmit unfocussed plane-wave ultrasound pulses into the subject;

sample reflections of the ultrasound pulses received at the single-element ultrasound transducer;

generate a time-series of pulse-Doppler response signals from the received reflections;

determine a selection of a tissue depth or depth range at which to monitor the characteristic of blood flow within the subject;

identify a time-series of one or more heartbeats from the pulse-Doppler response signals from the selected depth or depth range;

evaluate a quality metric for each of the identified one or more heartbeats from the selected depth or depth range, by comparing data associated with successive heartbeats by autocorrelation, to determine a respective quality value associated with each of the identified one or more heartbeats, wherein the quality value associated with each heartbeat depends on a similarity of data derived from the pulse-Doppler response signals for the respective heartbeat, to data derived from the pulse-Doppler response signals for a preceding heartbeat and wherein a higher value of the quality metric indicates a higher confidence that a heartbeat has been identified correctly;

determine a set of valid heartbeats consisting of heartbeats for which the respective quality value exceeds a threshold level; and

process the pulse-Doppler response signals from the selected depth or depth range over a time window to determine values of the characteristic of blood flow within the subject, over time, at the selected depth or depth range only over the set of valid heartbeats, comprising excluding from the time window periods of time covering pulse-Doppler response signals for which the identified heartbeats are determined as having a quality value below the threshold level, so as to evaluate the characteristic of blood flow only over those heartbeats for which the associated quality value exceeds the threshold level; and

wherein the controller is further configured to detect when one or more of the determined values of the characteristic of blood flow, for the set of valid heartbeats, satisfies a predetermined alert criterion, and, in response, to signal an audible or visual alert.

9. The system of claim 8 , further comprising a fastener or an adhesive layer for fastening the single-element ultrasound transducer to the subject.

10. The system of claim 8 , wherein the controller is configured to use an autocorrelation operation to identify heartbeats from the pulse-Doppler response signals.

11. The system of claim 8 , further comprising a display device, wherein the controller is further configured to display values of the characteristic of blood flow on the display device.

12. The system of claim 8 , wherein the controller is configured to receive, from a human operator, an input identifying the selected depth or depth range.

13. The system of claim 8 , wherein the controller is configured to automatically select the depth or depth range at which to determine the characteristic of blood flow.

14. The system of claim 8 , wherein the ultrasound transducer has a planar transmitting face having a width that is at least 10 mm.

15. The system of claim 8 , wherein the characteristic of blood flow is any of: a spatial-maximum velocity; a time-average of a spatial-maximum velocity; a peak systolic velocity; an end diastolic velocity; a pulsatile index; or a resistive index.

16. The system of claim 8 , wherein the characteristic of blood flow is time-averaged over the set of valid heartbeats.

17. The system of claim 8 , wherein the controller is further configured to detect displacement of the single-element transducer, relative to the subject, from the pulse-Doppler response signals.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 6, 2022
From: NORWEGIAN UNIVERSITY OF SCIENCE AND TECHNOLOGY (NTNU)
To: CIMON MEDICAL AS
Reel/Frame 058567/0344 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 22, 2020
From: TORP, HANS; HERGUM, TORBJORN
To: NORWEGIAN UNIVERSITY OF SCIENCE AND TECHNOLOGY (NTNU)
Reel/Frame 054142/0345 →
Priority Claims (2)
GB 1802007 · Feb 7, 2018 · national
GB 1817102 · Oct 19, 2018 · national
Continuity (1)
Related Publication 20210251599A1 · Aug 19, 2021
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