Systems and method of delivering fluids to a patient of varying concentration

• US 9,233,176 B2
• Filed: 06/06/2007
• Issued: 01/12/2016
• Est. Priority Date: 06/06/2006
• Status: Active Grant

• Current Assignee: Bayer Healthcare LLC (Bayer AG)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Lawaczek, Ruediger, Kalafut, John F.
• Primary Examiner(s): Berdichevsky, Aarti B
• Assistant Examiner(s): SCHELL, LAURA C
• Application Number:
  US12/302,907
• Publication Number:
  US 20090240142A1
• Time in Patent Office: 3,142 Days
• Field of Search: 600/420, 600430-435, 604/131, 604/151
• US Class Current: 1/1
• CPC Class Codes: A61K 49/0438 Organic X-ray contrast-enhancing agent comprising an iodinated group or an iodine atom, e.g. iopamidol
• CPC Class Codes: A61K 49/0447 Physical forms of mixtures of two different X-ray contrast-enhancing agents, containing at least one X-ray contrast-enhancing agent which is a halogenated organic compound
• CPC Class Codes: A61K 49/0452 Solutions, e.g. for injection
• CPC Class Codes: A61K 49/18 characterised by a special physical form, e.g. emulsions, microcapsules, liposomes
• CPC Class Codes: A61M 31/005 for contrast media
• CPC Class Codes: A61M 5/007 for contrast media

Abstract

A method for injection of an imaging contrast into a patient, includes: a. in a first phase, injecting a fluid having a first concentration of contrast agent for a first period of time; and b. in a second phase, injecting a fluid having a second concentration of contrast agent for a second period of time. The osmolarity of the second phase is higher than the osmolarity of the first phase. The method can further include: c. in a third phase, subsequent to the second phase, injecting a fluid having a third concentration of contrast agent for a third period of time. The osmolarity of the third phase is lower than the osmolarity of the second phase. In embodiments in which the composition of the contrast agent of the third phase is the same as the composition of the contrast agent of the second phase, the third concentration can be lower than the second concentration.

Claims

1. A method for injection of an imaging contrast into a patient, comprising:

a. in a first phase, injecting a fluid having a first concentration of contrast agent for a first period of time, wherein the fluid injected in the first phase is generally iso-osmolar to blood plasma;

b. in a second phase, subsequent to the first phase, injecting a fluid having a second concentration of contrast agent for a second period of time, the second concentration being such that the osmolarity of the second phase is higher than the osmolarity of the first phase; and

c. in a third phase, subsequent to the second phase, injecting a fluid having a third concentration of contrast agent for a third period of time, the third concentration being such that the osmolarity of the third phase is lower than the osmolarity of the second phase,

wherein the first concentration of contrast agent includes contrast,

wherein the third concentration of contrast agent includes contrast, and

wherein each of the first phase, the second phase, and the third phase proceed according to a set of injection parameters, including at least one of injection flow rate, injection volume, and injection duration, determined in advance of the first phase.

2. The method of claim 1 wherein the fluid injected in the first phase comprises an admixture of physiological saline and contrast agent or an admixture of a blood expander and contrast agent.

3. The method of claim 1 wherein the fluid injected in the first phase has a lower viscosity than the fluid injected in the second phase.

4. The method of claim 1 wherein the fluid injected in the first phase has a viscosity that is approximately equal to the viscosity of a physiological saline solution or of blood plasma.

5. The method of claim 1 wherein the fluid injected in the first phase has a viscosity of less than 9×

10<sup>−

3</sup> Pa·

s (9 centipoise).

6. The method of claim 1 wherein the fluid injected in the first phase has a viscosity of less than 5×

10<sup>−

3</sup> Pa·

s (5 centipoise).

7. The method of claim 1 wherein the fluid injected in the first phase has a viscosity of less than 3×

10<sup>−

3</sup> Pa·

s (3 centipoise).

8. The method of claim 1 wherein the fluid in the first phase is delivered in a volume of 0 to 200 ml per patient.

9. The method of claim 1 wherein the fluid injected in the third phase is generally iso-osmolar to blood plasma.

10. The method of claim 9 wherein the fluid injected in the third phase comprises an admixture of physiological saline and contrast agent or an admixture of a blood expander and contrast agent.

11. The method of claim 9 wherein the fluid injected in the third phase has a lower viscosity than the fluid injected in the second phase.

12. The method of claim 9 wherein the fluid injected in the third phase has a viscosity that is approximately equal to the viscosity of a physiological saline solution or of blood plasma.

13. The method of claim 9 wherein the fluid injected in the third phase has a viscosity of less than 9 centipoise.

14. The method of claim 9 wherein the fluid injected in the third phase has a viscosity of less than 5 centipoise.

15. The method of claim 9 wherein the fluid injected in the third phase has a viscosity of less than 3 centipoise.

16. The method of claim 1 wherein the fluid in the first phase is delivered in a volume of 0 to 200 ml per patient.

17. The method of claim 1 wherein the fluid in the third phase is delivered in a volume of 0 to 200 ml per patient.

18. The method of claim 1 wherein the fluid in the second phase is delivered in a volume of up to 200 ml per patient.

19. The method of claim 1 wherein the fluid in the second phase is delivered in a volume of up to 150 ml per patient.

20. The method of claim 1 wherein the flow injection rate of the first phase is equal to or greater than the injection flow rate of the second phase.

21. The method of claim 1 wherein the flow injection rate of the third phase is equal to or greater than the injection flow rate of the second phase.

22. The method of claim 1 wherein the first concentration and the third concentration are approximately equal.

23. The method of claim 1 wherein the fluid in the first phase and the fluid in the third phase are delivered from a first source and the fluid in the second phase is delivered from a second source.

24. The method of claim 1 wherein a first source of a diluent fluid is provided and a second source of a second fluid having a concentration of contrast agent is provided, the fluid in the first phase being formed by mixing the diluent fluid and the second fluid and the fluid in the third phase being formed by mixing the diluent fluid and the second fluid.

25. The method of claim 24 wherein the diluent fluid is water, physiological saline, an aqueous solution of at least one blood expander or pharmaceutical excipients.

26. The method of claim 24 wherein the fluid in the second phase is formed by mixing the diluent fluid and the second fluid.

27. The method of claim 1 wherein the contrast agent includes at least one of Br, Zr, Te, I, La, Ce, Pr, Nd, Sm, Eu, Gd, Tb, Dy, Ho, Er, Tm, Yb, Lu, Pt, Au, Hg, Pb and Bi.

28. The method of claim 1 wherein the contrast agent comprises at least one of an iodine containing monomer, an iodine containing dimer, a gadolinium containing monomer, a gadolinium containing dimer or a gadolinium containing oligomer.

29. The method of claim 28 wherein the contrast is ionic or nonionic.

30. The method of claim 1 wherein the fluid in the second phase is hyperosmolar with respect to blood.

31. The method of claim 1 wherein the contrast agent includes more than one contrast enhancing element.

32. The method of claim 1 wherein the contrast agent comprises at least one contrast enhancing element selected from an iodine-containing monomer, an iodine-containing dimer, a gadolinium-containing monomer, a gadolinium-containing dimer, and a gadolinium-containing oligomer.

33. The method of claim 1 wherein contrast agent in the first phase is of a different composition than the composition of contrast agent of the second phase or of the composition of contrast agent of the third phase.

34. The method of claim 1 wherein contrast agent in the third phase is of a different composition than contrast agent of the second phase or of a different composition than contrast agent of the first phase.

35. The method of claim 1 wherein the osmolarity of the first phase is within 20% of the osmolarity of the patient'"'"'s blood.

36. The method of claim 1 wherein the osmolarity of the first phase is within 10% of the osmolarity of the patient'"'"'s blood.

37. The method of claim 9 wherein the osmolarity of the third phase is within 20% of the osmolarity of the patient'"'"'s blood.

38. The method of claim 9, wherein the osmolarity of the third phase is within 10% of the osmolarity of the patient'"'"'s blood.