Blood glucose monitoring system

• US 20110184266A1
• Filed: 01/25/2010
• Published: 07/28/2011
• Est. Priority Date: 01/25/2010
• Status: Abandoned Application

• Current Assignee: Paul D. Levin
• Original Assignee: Paul D. Levin
• Inventors: Levin, Paul D.
• Application Number:
  US12/657,639
• Publication Number:
  US 20110184266A1
• Time in Patent Office: Days
• US Class Current: 600/365
• CPC Class Codes: A61B 5/14503 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors A61B5/1459, A61B5/1464, A61B5/1473, A61B5/1482, A61B5/14865 take precedence
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/4839 combined with drug delivery
• CPC Class Codes: A61M 39/105 Multi-channel connectors or couplings, e.g. for connecting multi-lumen tubes multi-channel connectors in general F16L37/56
• CPC Class Codes: A61M 5/1407 Infusion of two or more substances
• CPC Class Codes: A61M 5/14228 with linear peristaltic action, i.e. comprising at least three pressurising members or a helical member
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00

Abstract

A method and apparatus for blood glucose monitoring is provided which allows blood sampling and insulin infusion through the same catheter lumen of a multi-lumen, central venous catheter. It is designed to be used with a nearby continuous glucose sensor. The catheter lumen with the most proximal aperture leads to a connecting tube which is split into two parts, with both parts having a low internal volume. The described catheter allows for rapid switching between insulin delivery and blood sampling and minimizes the amount of purge fluid needed to clear the line.

Claims

1. In an apparatus for automatically and periodically sampling and testing blood glucose from blood samples withdrawn through an intravascular multi-lumen catheter inserted into the subclavian or other central vein of a patient, wherein a small testing unit is in fluid communication with said catheter, wherein said testing unit is cleared of blood after each test with a known purge volume of purging fluid, wherein a bedside monitor has at least one reversible peristaltic pump for either pumping blood samples outwardly from said patient into said testing unit, or pumping said blood samples from said testing unit inwardly and back into said patient through said catheter, the improvement comprising:

said intravascular multi-lumen catheter having a body and having a first part that is insertable into the subclavian or other central vein of said patient,

said multi-lumen catheter having a first Y-shaped connecting tubing having a stem end, a first arm and a second arm, with said stem end being in fluid communication with, and extending outwardly from said body,

said first arm being connected to said testing unit and forming a fluid connection between said stem end and said testing unit,

said second arm being connected to a source of insulin infusion fluid and forming a fluid connection between said stem end and said source of insulin infusion fluid,

said multi-lumen catheter having at least a second connecting tubing that extends outwardly from said body to form a fluid connection with a source of one other fluid to be infused into said patient through said intravascular catheter,

said stem and said first arm of said first Y-shaped connecting tubing having a combined internal volume of 0.1 mL or less,

wherein insulin is continuously infused through said stem of said first connecting tubing into said patient, except when blood samples are being withdrawn from said patient through said stem and said first arm of said first connecting tubing and then tested.

2. In the apparatus of claim 1, wherein each glucose testing cycle, including withdrawal of a blood sample, testing and purging are all completed in 3.0 minutes or less.

3. In the apparatus of claim 1, wherein both said stem and said first arm and said stem and said second arm of said first connecting tubing each have a combined internal volume of 0.02 mL or less.

4. In the apparatus of claim 3, wherein each glucose testing cycle, including withdrawal of a blood sample, testing and purging are all completed in less than 1.8 minutes.

5. A method for continuously infusing insulin solution through, and for periodically withdrawing and testing blood samples from, one lumen of a multi-lumen intravascular catheter connected to the subclavian or other central vein of a patient, wherein a small testing unit is worn by the patient near the body of said catheter, wherein the testing unit is cleared of blood after each test with a known volume of purge fluid, wherein a bedside monitor has at least one reversible peristaltic pump for either pumping blood samples outwardly from said catheter into said testing unit or pumping said blood samples from said testing unit inwardly and back into said patient through said catheter, and wherein a source of insulin solution is provided, comprising the steps:

providing a first fluid passageway extending from said catheter body to said testing unit, wherein said first fluid passageway has a volume of 0.1 mL or less,

providing a second fluid passageway that intersects with and in fluid communication with said first fluid passageway, and wherein said second fluid passageway is connected to said continuous source of insulin solution,

periodically actuating said reversible peristaltic pump to withdraw a blood sample through said one lumen of said multi-lumen catheter and through said first passageway into said testing unit,

testing said withdrawn blood sample in said testing unit,

pumping said blood sample from testing unit along with a known volume of purge fluid through said first passageway and said one lumen back into said patient,

continuously infusing insulin solution through said second passageway and through said one lumen of said multi-lumen catheter into said patient wherein said second passageway has an internal volume of 0.1 mL or less,

interrupting said continuous infusion of insulin for 3.0 minutes or less to withdraw, test and return said blood sample to said patient.

6. The method of claim 5 wherein each of said first and second fluid passageways extending from said catheter body has an internal fluid volume of 0.02 mL or less.

7. The method of claim 6, wherein said interruption of said infusion of less is less than 1.8 minutes to withdraw, test and return said blood sample to said patient.