System and apparatus for modeling pressures generated during an injection procedure

• US 9,238,099 B2
• Filed: 03/27/2007
• Issued: 01/19/2016
• Est. Priority Date: 11/24/2004
• Status: Expired due to Fees

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Kalafut, John F., Mishler, David A.
• Primary Examiner(s): Bosworth, Kami A
• Assistant Examiner(s): LEE, BRANDY SCOTT
• Application Number:
  US11/691,823
• Publication Number:
  US 20070213662A1
• Time in Patent Office: 3,220 Days
• Field of Search: 604/67, 604/118, 604/505
• US Class Current: 1/1
• 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 fluid injection apparatus includes at least one pressurizing mechanism and at least a first fluid container (for example, a syringe or a bulk container) operably associated with the at least one pressurizing mechanism. The first fluid container is adapted to contain a first fluid to be injected. The fluid injection apparatus also includes a pressure modeling system adapted to predict a pressure to be generated at one or more points in the injection fluid path during planned injection procedure based upon variables associated with an injection protocol.

Claims

1. A fluid injection apparatus comprising:

(a) at least one pressurizing mechanism to which a fluid path is operably connectible, the fluid path comprising at least one fluid container for containing at least one fluid therein, tubing operatively connectible to an outlet of the at least one fluid container, and a catheter operatively connectible to the tubing, the at least one pressurizing mechanism for pressurizing the at least one fluid within the at least one fluid container so as to inject the at least one fluid therein into the patient via the tubing and the catheter; and

(b) a controller operably associated with the at least one pressurizing mechanism and comprising a programming system, the programming system (I) enabling input by an operator thereof of a desired injection protocol of an injection procedure according to which the at least one fluid is intended to be injected into the patient and (II) having at least one algorithm for predicting an expected pressure level that would result at at least one point in the fluid path if the desired injection protocol were to be carried out by the fluid injection apparatus, the expected pressure level being determined before commencement of the desired injection protocol according to a pressure model in which at least one of a plurality of parameters relevant to the injection procedure is used as an input, the at least one of the plurality of parameters being selected from the group consisting of an inner diameter of the catheter and a hydraulic resistance of the catheter, the at least one algorithm being adapted to determine the expected pressure level before commencement of the desired injection protocol for a plurality of catheters of differing diameters;

the at least one algorithm further (A) if the expected pressure level is less than or equal to a pressure threshold value, enabling the desired injection protocol to be carried out by the fluid injection apparatus and (B) if the expected pressure level exceeds the pressure threshold value, alerting the operator whereupon the operator is enabled to choose between one of (i) permitting the desired injection protocol to be carried out by the fluid injection apparatus as programmed and (ii) changing at least one of the plurality of parameters and thereby update the desired injection protocol so that once the expected pressure level is determined via the pressure model to be less than or equal to the pressure threshold value, the desired injection protocol is enabled to be carried out by the fluid injection apparatus.

2. The fluid injection apparatus of claim 1, wherein the pressure threshold value is set by one of (i) the operator of the fluid injection apparatus and (ii) a manufacturer of the fluid injection apparatus.

3. The fluid injection apparatus of claim 1, wherein the at least one of the plurality of parameters of the injection procedure used in determining the expected pressure level according to the pressure model also includes a volumetric flow rate of the at least one fluid, a viscosity of the at least one fluid, and at least one characteristic of the tubing.

4. The fluid injection apparatus of claim 3, wherein the at least one characteristic of the tubing includes at least one of (i) an inner diameter of the tubing, (ii) a compliance of the tubing, and (iii) a hydraulic resistance of the tubing.

5. The fluid injection apparatus of claim 1, wherein when the expected pressure level is determined via the pressure model to be in excess of the pressure threshold value, the at least one of the plurality of parameters that the operator may change to update the desired injection protocol includes at least one of (i) a flow rate of the at least one fluid, (ii) a concentration of the at least one fluid, and (iii) a ratio of one fluid of the at least one fluid to another fluid of the at least one fluid.

6. A method of predicting pressure at at least one point within a fluid path comprising tubing and a catheter operatively connectible to the tubing and into which at least one fluid is introduced, the method comprising:

(a) planning a desired injection protocol according to which the at least one fluid is intended to be introduced into the fluid path under pressure via at least one pressurizing mechanism for pressurizing the at least one fluid;

(b) predicting an expected pressure level that would result at at least one point in the fluid path if the desired injection protocol were to be used as intended to introduce the at least one fluid into the fluid path, the expected pressure level being determined before commencement of the desired injection protocol according to a pressure model in which at least one of a plurality of parameters relevant to the desired injection protocol is used as an input, the at least one of the plurality of parameters being selected from the group consisting of an inner diameter of the catheter and a hydraulic resistance of the catheter;

(c) if the expected pressure level is less than or equal to a pressure threshold value, enabling the desired injection protocol to be used as intended to introduce the at least one fluid into the fluid path; and

(d) if the expected pressure level exceeds the pressure threshold value, performing one of;

(I) alerting a user of the method thereof whereupon the user is enabled to choose between one of (i) permitting the desired injection protocol to be used as intended to introduce the at least one fluid into the fluid path and (ii) changing at least one of the plurality of parameters and thereby update the desired injection protocol so that once the expected pressure level is determined via the pressure model to be less than or equal to the pressure threshold value, the desired injection protocol is enabled to be used to introduce the at least one fluid into the fluid path; and

(II) automatically changing at least one of the plurality of parameters and thereby update the desired injection protocol so that the expected pressure level will be determined via the pressure model to be less than or equal to the pressure threshold value thereby enabling the desired injection protocol to be used to introduce the at least one fluid into the fluid path.

7. The method of claim 6, wherein the at least one fluid is introduced into the fluid path by a fluid injection apparatus operating according to the desired injection protocol, the fluid injection apparatus having the at least one pressurizing mechanism for pressurizing the at least one fluid and a controller operably associated therewith through which to program the desired injection protocol according to which the at least one fluid is intended to be introduced into the fluid path and therethrough injected into a patient.

8. The method of claim 7, wherein the pressure threshold value is set by one of (i) an operator of the fluid injection apparatus and (ii) a manufacturer of the fluid injection apparatus.

9. The method of claim 6, wherein the at least one of the plurality of parameters of the desired injection protocol used in determining the expected pressure level according to the pressure model includes a volumetric flow rate of the at least one fluid, a viscosity of the at least one fluid, and at least one characteristic of the tubing.

10. The method of claim 9, wherein the at least one characteristic of the tubing includes at least one of (i) an inner diameter of the tubing, (ii) a compliance of the tubing and (iii) a hydraulic resistance of the tubing.

11. The method of claim 6, wherein when the expected pressure level is determined via the pressure model to be in excess of the pressure threshold value the at least one of the plurality of parameters that the user may change to update the desired injection protocol includes at least one of (i) a flow rate of the at least one fluid, (ii) a concentration of the at least one fluid, and (iii) a ratio of one fluid of the at least one fluid to another fluid of the at least one fluid.

12. An apparatus for predicting pressure at at least one point within a fluid path comprising tubing and a catheter connectible to the tubing into which at least one fluid is introduced for injection into a patient, the apparatus comprising:

(a) a controller for controlling at least one pressurizing mechanism through which the at least one fluid from at least one fluid container therefor is pressurized through the fluid path for injection into the patient; and

(b) a programming system operably associated with the controller, the programming system (I) enabling input by an operator thereof of a desired injection procedure according to which the at least one fluid is intended to be injected into the patient and (II) having at least one algorithm for predicting an expected pressure level that would result at the at least one point in the fluid path if the desired injection procedure were to be carried out by the apparatus, the expected pressure level being determined before commencement of the desired injection procedure according to a pressure model using at least one of a plurality of parameters on which the desired injection procedure is based, the at least one of the plurality of parameters being selected from the group consisting of an inner diameter of the catheter and a hydraulic resistance of the catheter;

the at least one algorithm further (A) if the expected pressure level is less than or equal to a pressure threshold value, enabling the desired injection procedure to be carried out by the apparatus and (B) if the expected pressure level exceeds the pressure threshold value, alerting the operator whereupon the operator is enabled to choose between one of (i) permitting the desired injection procedure to be carried out by the apparatus as programmed and (ii) changing at least one of the plurality of parameters and thereby update the desired injection procedure so that once the expected pressure level is determined via the pressure model to be less than or equal to the pressure threshold value the desired injection procedure is enabled to be carried out by the apparatus.

13. The apparatus of claim 12, wherein the pressure threshold value is set by one of (i) the operator of the apparatus and (ii) a manufacturer of the apparatus.

14. The apparatus of claim 12, wherein the at least one of the plurality of parameters of the injection procedure used in determining the expected pressure level according to the pressure model includes a volumetric flow rate of the at least one fluid, a viscosity of the at least one fluid, and at least one characteristic of the tubing.

15. The apparatus of claim 14, wherein the at least one characteristic of the tubing includes at least one of (i) an inner diameter of the tubing, (ii) a compliance of the tubing and (iii) a hydraulic resistance of the tubing.

16. The apparatus of claim 12, wherein when the expected pressure level is determined via the pressure model to be in excess of the pressure threshold value the at least one of the plurality of parameters that the operator may change to update the desired injection procedure includes at least one of (i) a flow rate of the at least one fluid, (ii) a concentration of the at least one fluid, and (iii) a ratio of one fluid of the at least one fluid to another fluid of the at least one fluid.

17. An apparatus for predicting pressure at at least one point within a fluid path comprising tubing and a catheter connectible to the tubing into which at least one fluid is introduced for injection into a patient, the apparatus comprising:

(a) a controller for controlling at least one pressurizing mechanism through which the at least one fluid from at least one fluid container therefor is pressurized through the fluid path into the patient; and

(b) a programming system operably associated with the controller, the programming system (I) enabling input by an operator thereof of a desired injection procedure according to which the at least one fluid is intended to be injected into the patient and (II) having at least one algorithm for predicting an expected pressure level that would result at the at least one point in the fluid path if the desired injection procedure were to be carried out by the apparatus, the expected pressure level being determined before commencement of the desired injection procedure according to a pressure model in which at least one of a plurality of parameters relevant to the injection procedure is used as an input, the at least one of the plurality of parameters being selected from the group consisting of an inner diameter of the catheter and a hydraulic resistance of the catheter;

the at least one algorithm further (A) if the expected pressure level is less than or equal to a pressure threshold value, enabling the desired injection procedure to be carried out by the apparatus and (B) if the expected pressure level exceeds the pressure threshold value, enabling the controller to automatically change at least one of the plurality of parameters and thereby update the desired injection procedure so that once the expected pressure level is determined via the pressure model to be less than or equal to the pressure threshold value the desired injection procedure is enabled to be carried out by the apparatus.

18. The apparatus of claim 17, wherein the pressure threshold value is set by one of (i) the operator of the apparatus and (ii) a manufacturer of the apparatus.

19. The apparatus of claim 17, wherein the at least one of the plurality of parameters of the injection procedure used in determining the expected pressure level according to the pressure model includes a volumetric flow rate of the at least one fluid, a viscosity of the at least one fluid, and at least one characteristic of the tubing.

20. The apparatus of claim 19, wherein the at least one characteristic of the tubing includes at least one of (i) an inner diameter of the tubing, (ii) a compliance of the tubing and (iii) a hydraulic resistance of the tubing.

21. The apparatus of claim 17, wherein when the expected pressure level is determined via the pressure model to be in excess of the pressure threshold value the at least one of the plurality of parameters that the operator may change to update the desired injection procedure includes at least one of (i) a flow rate of the at least one fluid, (ii) a concentration of the at least one fluid, and (iii) a ratio of one fluid of the at least one fluid to another fluid of the at least one fluid.