IP Library Granted Patent US 11,089,971
Granted Patent B2
US 11,089,971 · App. 15/321,685 · Granted Aug 17, 2021

Thermodilution injectate measurement and control

Inventors: Alexander H. Siemons (Yorba Linda, CA); Wei-Jiun Liu (Newport Beach, CA)
Assignee: Edwards Lifesciences Corporation
A61B5/028A61B5/029A61B5/0295A61B5/6852A61B5/7285A61B5/742A61B5/7275
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Quick Facts
Patent No.
US 11,089,971
App. No.
15/321,685
Granted
Aug 17, 2021
Kind
B2
Abstract

Apparatus and methods for the measurement, control, or both, of thermodilution injectate flow for calculation of transpulmonary thermodilution parameters. An injectate delivery system includes a syringe for holding an injectate and a conduit configured at one end to be connected to a catheter. A flow measurement device is interposed in the conduit to generate a signal for determining the flow rate of the fluid from the syringe to the catheter. A processor receives the signal from the flow measurement device and calculates the injectate volume to be used as input for calculating a transpulmonary thermodilution parameter such as cardiac output. A GUI is provided to direct a user on whether the injection rate is too fast or too slow. Rather than measuring or calculating flow rate, a system may include a constant flow valve to provide a constant flow rate from the syringe.

Claims (64)

1. An injectate delivery system, comprising:

a reservoir for holding a fluid injectate;

a conduit in fluid communication with the reservoir and configured at one end to be connected to a catheter, the conduit comprising an elongate tubing configured to receive discharged injectate from the reservoir;

an injector configured to discharge the fluid injectate from the reservoir to the conduit;

a flow measurement device interposed in the conduit between the reservoir and the catheter and within the elongate tubing, wherein the flow measurement device is configured to generate a signal; and

a processing device adapted to receive the signal from the flow measurement device and configured to calculate:

flow rate of the fluid injectate from the reservoir to the catheter based at least in part on the signal; and

injectate volume, based at least in part on the calculated flow rate, to be used as input for calculating at least one parameter.

2. The system of claim 1 , wherein the at least one parameter is cardiac output.

3. The system of claim 1 , wherein the reservoir is a reservoir of a syringe that includes a manually operable plunger as the injector.

4. The system of claim 3 , wherein the catheter is in fluid communication with the reservoir.

5. The system of claim 4 , wherein the catheter is a Swan-Ganz catheter.

6. The system of claim 1 , wherein the flow measurement device is configured to generate the signal based on differential pressure.

7. The system of claim 1 , further comprising:

a first pressure sensor situated upstream of the flow measurement device and in line with the elongate tubing; and

a second pressure sensor situated downstream of the flow measurement device and in line with the elongate tubing;

wherein the first and second pressure sensors are configured to measure a pressure drop across the flow measurement device.

8. The system of claim 1 , further comprising:

a first pressure sensor situated upstream of the flow measurement device and in line with the elongate tubing; and

a second pressure sensor situated downstream of the flow measurement device and in line with the elongate tubing;

wherein:

the first and second pressure sensors are configured to measure vortex differential pressure, and

the flow measurement device defines an area of constricted flow.

9. The system of claim 1 , wherein the flow measurement device comprises a Venturi tube.

10. The system of claim 1 , wherein the flow measurement device comprises one or more pitot tubes.

11. The system of claim 1 , wherein the flow measurement device comprises a hot wire anemometer.

12. The system of claim 1 , further comprising a sensor interposed in the conduit downstream of the flow measurement device, wherein the sensor is configured to detect changes in pressure or temperature of the fluid injectate and to signal a timer to start at a beginning of an injection of the injectate and stop at an end of the injection to measure elapsed time of the injection.

13. The system of claim 1 , wherein the processing device is further configured to display the calculated flow rate of the fluid injectate in real time.

14. The system of claim 1 , further comprising a valve for allowing discharge from the reservoir, wherein the flow measurement device is situated downstream of the valve.

15. The system of claim 1 , wherein the flow measurement device is not situated within the reservoir or the injector.

16. The system of claim 1 , wherein the flow measurement device is entirely within the elongate tubing.

17. An injectate delivery system, comprising:

a reservoir for holding a fluid injectate;

a conduit in fluid communication with the reservoir and configured at one end to be connected to a catheter;

an injector configured to discharge the fluid injectate from the reservoir to the conduit;

a first pressure sensor connected in line with the conduit, wherein the first pressure sensor is configured to generate a first signal;

a second pressure sensor connected in line with the conduit;

a flow measurement device interposed in the conduit downstream of a first connection point between the first pressure sensor and the conduit and upstream of a second connection point between the second pressure sensor and the conduit, the flow measurement device comprising:

a pressure reducing feature; and

configured to generate a third signal;

wherein:

the first pressure sensor is further configured to generate the first signal in response to detecting an increase in pressure;

the first pressure sensor or the second pressure sensor is configured to generate a second signal in response to detecting a decrease in pressure; and

the processing device is further configured to:

start a timer upon receiving the first signal;

receive the second signal;

stop the timer upon receiving the second signal;

receive the third signal;

calculate flow rate of the injectate based at least in part on the third signal;

determine cardiac output based at least in part on:

an elapsed time between the first signal and the second signal; and

the calculated flow rate.

18. The injectate delivery system of claim 17 , further comprising:

a constant flow valve in line with the conduit and configured to maintain a constant flow rate at the conduit; and

a temperature sensor configured to generate a fourth signal;

wherein the processing device is further configured to determine cardiac output based at least in part on the first signal, the fourth signal, and the constant flow rate.

19. The injectate delivery system of claim 17 , further comprising:

a constant flow valve in line with the conduit and configured to maintain a constant flow rate at the conduit, wherein:

the first pressure sensor is further configured to generate the second signal in response to detecting the decrease in pressure; and

the processing device is further configured to:

start the timer upon receiving the first signal;

receive the second signal;

stop the timer upon receiving the second signal; and

calculate volume of the injectate based at least in part on the constant flow rate and an elapsed time between the first signal and the second signal.

Assignments (5)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 25, 2025
From: EDWARDS LIFESCIENCES CORPORATION; EDWARDS LIFESCIENCES LLC; EDWARDS LIFESCIENCES SÀRL; EDWARDS LIFESCIENCES HOLDING B.V.
To: BD SWITZERLAND SARL
Reel/Frame 072920/0001 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 13, 2021
From: SIEMONS, ALEX H.; LIU, WEI-JIUN
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 056843/0488 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 13, 2021
From: SIEMONS, ALEXANDER H.; LIU, WEI-JIUN
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 056843/0577 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 8, 2021
From: SIEMONS, ALEXANDER H.; LIU, WEI-JIUN
To: CORPORATION, EDWARDS LIFESCIENCES
Reel/Frame 056795/0179 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 20, 2017
From: SIEMONS, ALEXANDER J.; LIU, WEI-JIUN
To: EDWARDS LIFESCIENCES CORPORATION
Reel/Frame 041030/0367 →
Continuity (1)
Related Publication 20170265756A1 · Sep 21, 2017