Devices, systems and methods for determining parameters of one or more phases of an injection procedure

• US 10,166,326 B2
• Filed: 03/13/2015
• Issued: 01/01/2019
• Est. Priority Date: 11/24/2004
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Kalafut, John F., Mishler, David A.
• Primary Examiner(s): Lee, Brandy S
• Application Number:
  US14/657,216
• Publication Number:
  US 20150182687A1
• Time in Patent Office: 1,390 Days
• CPC Class Codes: A61B 6/507 for determination of haemodynamic parameters, e.g. perfusion CT
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 5/007 for contrast media
• CPC Class Codes: A61M 5/14546 Front-loading type injectors
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A system for enabling delivery of fluid in an injection procedure to be performed on a patient in connection with a diagnostic imaging procedure is disclosed. The system includes a controller operably associated with at least one pressurizing mechanism though which at least one of a first and a second fluid contained within at least one fluid container is injectable into the patient. The first fluid includes a contrast enhancing agent while the second fluid does not. The controller includes a programming system for programming an injection protocol having a plurality of phases to effect enhancement of at least one region of interest of the patient over a scan duration of the diagnostic imaging procedure. The programming system includes an algorithm that enables computation of a ratio of the first and second fluids based on at least a peak enhancement that occurs in at least one region of interest.

Claims

1. A system for enabling delivery of fluid in an injection procedure to be performed on a patient in connection with a diagnostic imaging procedure, the system comprising:

(a) a controller operably associated with at least one pressurizing mechanism though which at least one of a first fluid and a second fluid contained within at least one fluid container is injectable into the patient, the first fluid comprising a contrast enhancing agent and adapted to enhance contrast of images obtained during the diagnostic imaging procedure, the second fluid comprising a non-contrast enhancing fluid;

(b) the controller including a programming system for programming of an injection protocol comprising a plurality of phases to effect enhancement of at least one region of interest of the patient over a scan duration of the diagnostic imaging procedure, the plurality of phases comprising a first phase in which the first fluid is to be injected and a second phase in which an admixture of the non-contrast enhancing fluid with the first fluid is to be injected;

(c) a parameter generator inclusive of an algorithm associated with the programming system, the parameter generator for determining parameters of the injection protocol based in part upon a type of the injection procedure to be performed and the algorithm according to which at least a volume of the first phase, Vol₁, and a volume of the second phase, Vol₂, are determined using;

Vol₁=duration_scan×

Q₁ and

Vol₂=((t_{scan_end}−

propagation delay)−

duration₁)×

Q₂

where duration_scan is the scan duration, Q₁ is a flow rate of the first phase;

duration₁ is a duration of the first phase, propagation delay is a delay in propagation of the contrast enhancing fluid from an injection site to the at least one region of interest, Q₂ is a flow rate of the second phase, and t_scan-end is computed using;

t_scan-end=t_{test-bolus-peak}+duration_scan

where t_{test-bolus-peak} is a time to peak enhancement that can be obtained from an injection of a test bolus of the contrast enhanced fluid into the patient; and

(d) the parameter generator is further characterized in that the algorithm enables computation of a ratio of the admixture based on at least a peak enhancement that occurs in the at least one region of interest as a result of the injection of the test bolus.

2. The system of claim 1 wherein the ratio of the admixture is computed based on a magnitude of the peak enhancement occurring as a result of the injection of the test bolus, as follows:

(a) the ratio=30/70 if the peak enhancement>

160 HU;

(b) the ratio=50/50 if the peak enhancement≤

160 HU;

or

(c) the ratio=70/30 if the peak enhancement<

120 HU;

where HU is Hounsfield Units.

3. The system of claim 1 wherein the parameter generator is also adapted to determine the ratio of the admixture in the second phase based on at least one physiological variable of the patient.

4. The system of claim 1 wherein the least one physiological variable of the patient includes weight, cardiac output, and body mass index.

5. The system of claim 1 wherein the parameter generator is adapted to generate parameters based on at least one additional variable.

6. The system of claim 5 wherein the at least one additional variable is one of a concentration of a contrast agent in the contrast enhancing fluid within the first fluid and a physiological variable of the patient.

7. The system of claim 1 wherein the controller provides a choice to an operator of the system as to whether to program the parameters manually or to have the parameters programmed by the parameter generator.

8. The system of claim 1 wherein the parameters programmed by the parameter generator can be changed manually by an operator.

9. The system of claim 1 wherein an operator of the system chooses the type of injection procedure from a plurality of predefined types of injection procedures.

10. The system of claim 1 wherein an operator of the system can choose the algorithm from a plurality of algorithms adapted to be used by the parameter generator to generate the parameters.

11. The system of claim 1 wherein the algorithm enables computation of the ratio of the admixture also based on a time to peak enhancement that occurs in the at least one region of interest as a result of the injection of the test bolus.

12. The system of claim 1 wherein the least one region of interest includes one region that is a left compartment of the heart and another region that is right compartment of the heart.

13. The system of claim 1 wherein the least one region of interest includes one region that is a first portion of the liver and another region that is another portion of the liver.

14. The system of claim 1 wherein the plurality of phases includes a third flushing phase in which a volume of a flushing fluid therein, Vol₃, is determined using:

Vol₃=propagation delay×

Q₃

where Q₃ is a flow rate of the third phase.

15. A system for enabling delivery of fluid in an injection procedure to be performed on a patient in connection with a diagnostic imaging procedure, the system comprising:

(a) a controller operably associated with at least one pressurizing mechanism though which at least one of a first fluid and a second fluid contained within at least one fluid container is injectable into the patient, the first fluid comprising a contrast enhancing agent and adapted to enhance contrast of images obtained during the diagnostic imaging procedure, the second fluid being a non-contrast enhancing fluid; and

(b) the controller including a programming system for programming of an injection protocol comprising a plurality of phases to effect enhancement of at least one region of interest of the patient over a scan duration of the diagnostic imaging procedure, the plurality of phases comprising a first phase in which the first fluid is to be injected and a second phase, subsequent to the first phase, in which an admixture of the second fluid with the first fluid is to be injected such that the admixture of the second fluid with the first fluid decreases a concentration of the contrast enhancing agent in a combined fluid that results therefrom as compared to the concentration of the contrast enhancing agent in the first fluid of the first phase;

wherein the programming system includes an algorithm that enables computation of a ratio of the admixture based on at least a peak enhancement that occurs in the at least one region of interest as a result of an injection of a test bolus into the patient prior to performance of the diagnostic imaging procedure.

16. A method of delivering fluid in an injection procedure to be performed on a patient in connection with a diagnostic imaging procedure, the method comprising:

(a) providing a first fluid container comprising a first fluid, the first fluid comprising a contrast enhancing agent and adapted to enhance contrast of images obtained during the diagnostic imaging procedure;

(b) providing a second fluid container comprising a second fluid, the second fluid comprising a non-contrast enhancing fluid;

(c) providing at least one pressurizing mechanism operably associated with the first and the second fluid containers;

(d) providing a controller operably associated with the at least one pressurizing mechanism, the controller comprising a programming system for programming of an injection protocol comprising a plurality of phases to effect enhancement of at least one region of interest of the patient over a scan duration of the diagnostic imaging procedure; and

(e) programming the injection protocol such that in a first phase of the plurality of phases only the first fluid will be injected into the patient and in a second phase, subsequent to the first phase, an admixture of the second fluid with the first fluid will be injected into the patient such that the admixture of the second fluid with the first fluid decreases a concentration of the contrast enhancing agent in a combined fluid that results therefrom as compared to the concentration of the contrast enhancing agent in the first fluid of the first phase.

17. The method of claim 16 wherein the programming system includes an algorithm that enables computation of a ratio of the admixture based on at least a peak enhancement that occurs in the at least one region of interest as a result of an injection of a test bolus into the patient prior to performance of the diagnostic imaging procedure.