Method and apparatus for in vivo determination of the concentration in a body fluid of metabolically significant substances

• US 5,680,858 A
• Filed: 07/06/1995
• Issued: 10/28/1997
• Est. Priority Date: 12/10/1992
• Status: Expired due to Fees

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Ege, Henrik, Hansen, Henrik-Egesborg, Plum, Thomas Munk
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US08/448,351
• Time in Patent Office: 845 Days
• Field of Search: 128/635, 128/760, 128/771, 604/289, 604/290, 204/403
• US Class Current: 600/345
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/6848 Needles

Abstract

A method for in vivo determination of the concentration in a body fluid of metabolically significant substance comprises storing of a needle with a sensor in a liquid-filled ampoule, brief insertion of the needle into a patient, recording of the output signal from the sensor, withdrawal of the needle, and calculation of the concentration looked for on the basis of the recorded signals. The method is preformed using an apparatus comprising a needle (5) with a sensor (6), an ampoule (1) containing a solution (2) and closed by two membranes (3, 4). The needle (5) is stored with its sensor (6) in the solution. The apparatus further comprises a mechanical unit for driving the needle (5) to protrude from the ampoule for a set moment, and an electronic unit storing the output signal from the sensor (6) and performing calculations on the basis of the stored signal values. The needle with its sensor (6) and the ampoule with the solution (2) are independent disposable parts mounted in a durable part containing the mechanical and electronic parts.

Claims

1. A method for in vivo determination of a body fluid'"'"'s concentration of at least one metabolically significant substance, the method comprising the steps of:

(a) temporarily inserting a needle for a short duration of time, the needle being stored and having a sensor, into the tissue of a person whose body fluid shall be analyzed;

(b) recording an output signal from the sensor;

(c) withdrawing the needle and

(d) calculating the concentration of the metabolically significant substance by extrapolation of the recorded output signal.

2. A method according to claim 1 wherein the needle is inserted for a duration of 1-100 seconds.

3. A method according to claim 1 wherein the needle is inserted for less than 5 seconds.

4. A method according to claim 1 wherein the needle with the sensor is stored in one or more aqueous solutions.

5. A method according to claim 4 wherein at least one aqueous solution is used for sterilizing the sensor.

6. A method according to claim 5 wherein the sterilizing agent is Merthiolate.

7. A method according to claim 4 wherein at least one of the aqueous solutions is used for calibrating the sensor.

8. A method according to claim 7 wherein the output signal from the needle is measured during the storage of the needle in at least one calibrating solution and is compared with the output signal from the sensor when the needle returns to at least one calibrating solution and an error is registered if these signals differ by more than a set amount.

9. A method according to claim 1 wherein the metabolically significant substance is glucose.

10. An apparatus for carrying out the method of claim 1, wherein the apparatus comprises:

(a) a needle being stored and having a sensor at one end and being provided with a member by which the needle can be displaced in its longitudinal direction;

(b) leads connected to the sensor to transmit signals from the sensor to an electronic unit for recording and processing the signals on the basis of set criterions;

(c) a vial containing at least one aqueous solution, the vial being closed by membranes opposite each other at the ends of the vial, which membranes are leak proof when penetrated by the needle, the needle being displaceable perpendicularly to the membranes between a position wherein the needle penetrates one of the membranes so that its end, carrying the sensor, is positioned in the vial between the two membranes and another position wherein the needle penetrates both the membranes so that the needle'"'"'s end, carrying the sensor, protrudes from one of the membranes.

11. An apparatus according to claim 10 wherein that the sensor is selected from the group consisting of:

an electrochemical sensor or optical needle glucose sensor.

12. An apparatus according to claim 10 wherein the needle with the sensor and the vial with the aqueous solution are independently disposable, after being used one or more times.