Patient-based parameter generation systems for medical injection procedures

• US 9,302,044 B2
• Filed: 12/21/2007
• Issued: 04/05/2016
• Est. Priority Date: 12/29/2006
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Kalafut, John, McCutchan, Larry, Cosgrove, Erin
• Primary Examiner(s): Cwern, Jonathan
• Application Number:
  US12/519,213
• Publication Number:
  US 20100113887A1
• Time in Patent Office: 3,028 Days
• Field of Search: 600/431
• US Class Current: 1/1
• CPC Class Codes: A61B 6/032 Transmission computed tomography [CT]
• CPC Class Codes: A61B 6/037 Emission tomography
• CPC Class Codes: A61B 6/507 for determination of haemodynamic parameters, e.g. perfusion CT
• CPC Class Codes: A61B 6/544 dependent on patient size
• CPC Class Codes: A61B 8/481 involving the use of contrast agent, e.g. microbubbles introduced into the bloodstream analysis of echo signal exploiting properties of a contrast enhancer in devices for short-range imaging with acoustic waves G01S7/52039
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• 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 5/1452 pressurised by means of pistons
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• CPC Class Codes: G16H 30/40 for processing medical images, e.g. editing
• CPC Class Codes: G16H 40/63 for local operation

Abstract

A system includes a parameter generation system to determine parameters of at least one phase of an injection procedure based at least in part upon a type of the injection procedure. The parameter generator system determines the amount of a pharmaceutical that is to be delivered to a patient at least in part on the basis of the concentration of an agent in the pharmaceutical and at least on part on the basis of a function that depends upon and varies with a patient parameter. The patient parameter can, for example, be weight, body mass index, body surface area or cardiac output. The pharmaceutical can, for example, include a contrast enhancing agent for use in an imaging procedure.

Claims

1. A system, comprising:

a first pressurizing drive member adapted to be operably associated with at least a first fluid container, the first fluid container being adapted to contain a pharmaceutical comprising a contrast enhancing agent to be injected in an imaging procedure; and

a controller operably associated with the first pressurizing drive member, the controller comprising a programming system to allow programming of an injection protocol via which injection of the pharmaceutical from the at least a first fluid container is controlled, the injection protocol comprising at least a first phase;

a parameter generation system in communication with the controller and comprising a processor, a memory system and an input system, the processor executing an algorithm stored in the memory system, the algorithm determining parameters of the at least a first phase of the injection protocol based at least in part upon a type of the injection protocol identified via the input system, wherein the parameter generation system determines a volume of the pharmaceutical that is to be delivered to a patient at least partly on the basis of a concentration of the contrast enhancing agent in the pharmaceutical identified via the input system and at least partly on the basis of a function X having a value that differs depending upon a weight of the patient input via the input system.

2. The system of claim 1 wherein at least a first portion V₁ of the volume of the pharmaceutical to be delivered to the patient is calculated using the formula:

V₁=weight*X*Y,

wherein Y is a function of the concentration of the contrast enhancing agent in the pharmaceutical.

3. The system of claim 2 wherein X is determined for the weight of a particular patient from an algorithm in which X is calculated as a function of weight.

4. The system of claim 2 wherein X is determined for the weight of a particular patient from a table wherein X is set forth as a function of weight.

5. The system of claim 2 further comprising:

a second pressurizing drive member adapted to be operably associated with at least a second fluid container, the second fluid container adapted to contain a diluent fluid;

wherein the controller is operably associated with the second pressurizing drive member, and wherein V₁ is the volume of the pharmaceutical to be delivered in a phase in which only the pharmaceutical is to be delivered to the patient, the parameter generation system also determining a volume V₂ of the pharmaceutical to be delivered in at least a second phase in which both the pharmaceutical and the diluent fluid are to be delivered to the patient.

6. The system of claim 5 wherein a flow rate of the pharmaceutical delivered in the first phase is approximately equal to a flow rate of an admixture of the pharmaceutical and the diluent fluid delivered in the second phase.

7. The system of claim 6 wherein the flow rate of the pharmaceutical is calculated by dividing V₁ by an injection duration of the first phase.

8. The system of claim 7 wherein the injection duration of the first phase is determined by adding a factor K to a scan duration of an imaging system.

9. The system of claim 8 wherein K ranges from 0 to 10 seconds.

10. The system of claim 9 wherein a minimum for the injection duration of the first phase can be input into the parameter generation system.

11. The system of claim 10 wherein the flow rate of the pharmaceutical delivered in the first phase is calculated by dividing V₁ by the injection duration of the first phase.

12. The system of claim 6 wherein the volume V₂ of the pharmaceutical to be delivered to the patient in the second phase is calculated based at least in part on a parameter of the patient selected from the group consisting of weight, body mass index, body surface area, and cardiac output.

13. The system of claim 12 wherein the parameter generation system determines whether a total volume of the pharmaceutical to be delivered to the patient in all phases exceeds an available volume of the pharmaceutical available for delivery to the patient, the parameter generation system further comprising rules to reduce the total volume of the pharmaceutical if the total volume exceeds the available volume.

14. The system of claim 5 wherein a total volume of the pharmaceutical to be delivered to the patient in all phases is determined.

15. The system of claim 14 wherein an initial protocol determined by the parameter generation system to determine the total volume of the pharmaceutical to be delivered to the patient is adjusted based upon a characterization of a cardiovascular system of the patient.

16. The system of claim 15 wherein a test bolus of the pharmaceutical is performed to characterize the cardiovascular system of the patient.

17. The system of claim 16 wherein the initial protocol is adjusted at least in part on the basis of a time to peak enhancement of the test bolus.

18. The system of claim 16 wherein the initial protocol is adjusted at least in part on the basis of a time to peak enhancement of the test bolus and a level of enhancement of the peak enhancement.

19. The system of claim 2 wherein X decreases nonlinearly with increasing weight of the patient.