CALIBRANT INFUSION FLUID SOURCE PREPARATION

• US 20130228002A1
• Filed: 04/17/2013
• Published: 09/05/2013
• Est. Priority Date: 07/01/2009
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Petisce, James R., Higgins, Michael, Abraham, Todd, Trinh, Kristie P.
• Application Number:
  US13/864,936
• Publication Number:
  US 20130228002A1
• Time in Patent Office: Days
• 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 and a predetermined concentration of glucose;

applying a hermetic containment to the calibrant infusion fluid source and

removing the hermetic containment proximate in time to conducting a calibration procedure.

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, the predetermined concentration of glucose and an anti-clotting agent.

3. The method of claim 2, wherein providing the calibrant infusion fluid source further comprises providing the calibrant infusion fluid source that includes the saline solution, a predetermined concentration of glucose and heparin.

4. The method of claim 1, wherein applying a hermetic containment further comprises wrapping the calibrant infusion fluid source in a hermetic material.

5. The method of claim 4, wherein wrapping the calibrant infusion fluid source in a hermetic material further comprises wrapping the calibrant infusion fluid source in one of a metalized plastic or a metal foil.

6. The method of any of claim 1, wherein applying a hermetic containment further comprises placing the calibrant infusion fluid source in a metalized bag.

7. The method of claim 6, wherein applying a hermetic containment further comprises heat-sealing the metalized bag after placing the calibrant infusion fluid source in the metalized bag.