Calibrant infusion fluid source preparation

• US 8,438,898 B2
• Filed: 06/30/2010
• Issued: 05/14/2013
• Est. Priority Date: 07/01/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Petisce, James R., Higgins, Michael J., Trinh, Kristie, Abraham, Todd
• Primary Examiner(s): Macchiarolo, Peter
• Assistant Examiner(s): MILLER, ROSE MARY
• Application Number:
  US12/827,802
• Publication Number:
  US 20110154880A1
• Time in Patent Office: 1,049 Days
• Field of Search: 73/10.2, 73/10.3, 600/347, 600/345, 600/635, 600/309, 436/8, 436/11, 436/14, 436/18
• US Class Current: 73/1.03
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: A61M 2230/201 Glucose concentration
• CPC Class Codes: G01N 33/96 involving blood or serum control standard
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/102499 Blood gas standard or control
• CPC Class Codes: Y10T 436/104998 Glucose, ketone, nitrate standard or control
• CPC Class Codes: Y10T 436/108331 Preservative, buffer, anticoagulant or diluent

Abstract

Methods and systems for preparation of calibrant infusion fluid sources are disclosed. In one embodiment, a precise volume of glucose is injected into a saline-solution filled calibrant infusion fluid source proximate in time to conducting a calibration procedure. The glucose concentration in the calibrant infusion fluid source is subsequently calculated based on the measured weight of the saline-solution, as determined prior to glucose injection, and the volume of glucose injected. This method provides a highly accurate and convenient manner for use in a hospital environment, for example, with an intravenous blood glucose sensor system. In another embodiment, a premixed calibrant infusion fluid source is provided that includes saline solution and a predetermined concentration of glucose. In such embodiments, shelf life problems related to water evaporation are mitigated by hermetically covering or otherwise hermetically containing the calibrant infusion fluid source up until the point of use.

Claims

1. A method for preparing a calibrant infusion fluid source, the method comprising:

providing a calibrant infusion fluid source that includes a saline solution;

determining content weight in the calibrant infusion fluid source;

adding a predetermined volume of a predetermined glucose concentrate into the calibrant infusion fluid source; and

determining a concentration of glucose in the calibrant infusion fluid source based on the content weight in the calibrant infusion fluid source and the predetermined volume of the predetermined glucose concentrate,

wherein a calibration procedure ensues proximate in time to adding the predetermined volume of the predetermined glucose concentrate into the calibrant infusion fluid source.

2. The method of claim 1, wherein providing the calibrant infusion fluid source further comprises providing the calibrant infusion fluid source that includes the saline solution and an anti-clotting agent.

3. The method of claim 2, wherein providing the calibrant infusion fluid source that includes the saline solution and an anti-clotting agent further comprises providing the calibrant infusion fluid source that includes the saline solution and heparin.

4. The method of claim 3, wherein providing the calibrant infusion fluid source that includes the saline solution and heparin further comprises providing the calibrant infusion fluid source that includes about 0.9 percent by weight sodium chloride and 1000 units of heparin sodium salt in 500 ml.

5. The method of claim 1, wherein determining content weight in the calibrant infusion fluid source further comprises weighing the calibrant infusion fluid source and subtracting an empty calibrant infusion fluid source weight from the weight of the calibrant infusion fluid source.

6. The method of claim 1, wherein adding the predetermined volume further comprises injecting the predetermined volume of the predetermined glucose concentrate into the calibrant infusion fluid source.

7. The method of claim 1, wherein injecting the predetermined volume further comprises injecting the predetermined volume of the predetermined glucose concentrate using a syringe having a volume-controlling mechanism.

8. The method of claim 7, wherein injecting the predetermined volume further comprises injecting the predetermined volume of the predetermined glucose concentrate using the syringe having the volume-controlling mechanism, wherein the volume-controlling mechanism is selected from a dimpled stop or a tapered barrel.

9. The method of claim 1, wherein injecting the predetermined volume further comprises injecting the predetermined volume of the predetermined glucose concentrate using a previously un-used syringe.

10. The method of claim 9, wherein injecting the predetermined volume further comprises injecting the predetermined volume of the predetermined glucose concentrate using the previously un-used syringe, wherein the injection is a single injection of the syringe absent a flush.

11. The method of claim 10, wherein adding the predetermined volume further comprises adding the predetermined volume of the predetermined glucose concentrate into the calibrant infusion fluid source, wherein the predetermined volume is based on the predetermined glucose concentrate and the volume of the content in the calibrant infusion fluid source.

12. The method of claim 1, further comprising providing the determined concentration of glucose in the calibrant infusion fluid source to an intravenous blood glucose system.

13. A system for preparing a calibrant infusion fluid source, the system comprising:

a calibrant infusion fluid source including a saline solution;

a weighing device operable to determine a weight of the calibrant infusion fluid source a syringe operable to inject a predetermined volume of a predetermined glucose concentrate into the calibrant infusion fluid source; and

a calculation device operable to calculate a concentration of glucose in the calibrant infusion fluid source based on a content weight in the calibrant infusion fluid source and the predetermined volume of the predetermined glucose concentrate,

wherein a calibration procedure ensues proximate in time to injecting the predetermined volume of the predetermined glucose concentrate into the calibrant infusion fluid source.

14. The system of claim 13, wherein the calibrant infusion fluid source further comprises the calibrant infusion fluid source including the saline solution and an anti-clotting agent.

15. The system of claim 14, wherein the calibrant infusion fluid source further comprises the calibrant infusion fluid source including the saline solution and heparin.

16. The system of claim 15, wherein the calibrant infusion fluid source including the saline solution and heparin further comprises the calibrant infusion fluid source including about 0.9 percent by weight sodium chloride and 1000 units of heparin sodium salt in 500 ml.

17. The system of claim 13, wherein the calculation device if further operable to determine the content weight in the calibrant infusion fluid source by subtracting an empty calibrant infusion fluid source weight from the weight of the calibrant infusion fluid source including the saline solution.

18. The system of claim 13, wherein the syringe further comprises a volume-controlling mechanism.

19. The system of claim 18, wherein the volume controlling mechanism further comprises a dimpled stop or a tapered barrel.

20. The system of claim 13, wherein the syringe further comprises a previously un-used syringe.