Device for determining the concentration of at least one substance in organic tissue

• US 5,243,982 A
• Filed: 07/18/1991
• Issued: 09/14/1993
• Est. Priority Date: 07/19/1990
• Status: Expired due to Term

• Current Assignee: Avl Medical Instruments AG (Roche Holding AG)
• Original Assignee: Avl Medical Instruments AG (Roche Holding AG)
• Inventors: Mayer, Michael, Mostl, Anton
• Primary Examiner(s): Cohen, Lee S.
• Assistant Examiner(s): GILBERT, SAMUEL G
• Application Number:
  US07/732,401
• Time in Patent Office: 789 Days
• Field of Search: 604/27, 604/30, 604/35, 604/153-155, 604/191, 604/65-67, 604/891.1, 128/632, 128/633, 128/635, 128/DIG. 12
• US Class Current: 600/316
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61M 2005/1726 the body parameters being measured at, or proximate to, the infusion site
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: Y10S 128/12 Pressure infusion

Abstract

A device for determining the concentration of at least one substance in organic tissue includes a subcutaneous needle for insertion into the tissue and a pumping and suction unit which is controlled by a microprocessor and is used for delivering a perfusion fluid and draining it after its partial equilibration with the tissue. The device further includes a sensing unit connected to the microprocessor for determining the concentration of the substance to be analyzed and one or more marker variables. The perfusion fluid, a calibrating solution and at least one drug are provided in replaceable metering ampoules sealed with membranes, whose metering plungers can be actuated by a drive unit controlled by the microprocessor. The metering ampoules communicate with a master capillary leading from the pumping and suction unit to the subcutaneous needle; communication is established via capillary tubes piercing the membranes.

Claims

1. A device for determining a concentration of at least one substance in organic tissue, comprising

a subcutaneous needle which is insertable into said organic tissue,

a microprocessor and a sensing unit means which is connected to said microprocessor for determining the concentration of said substance to be determined and at least one endogenous or exogenous marker variable of a perfusion fluid,

a pumping and suction unit means for feeding said perfusion fluid into said subcutaneous needle and for draining said perfusion fluid after partial equilibration with said at least one substance, said pumping and suction unit means being controlled by said microprocessor,

replaceable metering ampoules sealed with membranes containing said perfusion fluid, a calibrating solution and at least one drug, and drive unit means for actuating metering plungers of said metering ampoules, said drive unit means controlled by said microprocessor, and wherein said metering ampoules communicate with a master capillary leading from said pumping and suction unit means to said subcutaneous needle, communication being established via capillary tubes piercing said membranes of said metering ampoules.

2. A device according to claim 1, wherein all entrance points of said capillary tubes into said master capillary are provided with check valves opening at a defined level of excess pressure inside said capillary tubes.

3. A device according to claim 2, wherein each of said check valves comprises a piece of flexible tubing inserted into said master capillary, each said piece being placed at said entrance point of said capillary tube.

4. A device according to claim 1, essentially configured as a four-part assembly comprising

a housing, as a first part, containing said microprocessor and a communication unit attached thereto, said drive unit means for actuating said metering plungers of said metering ampoules, said pumping and suction unit, means receiving positions for at least one drug metering ampoule, a replacement unit, and an energy supply,

a second part embracing said replacement unit insertable into said housing, said replacement unit holding said sensing unit means, said master capillary together with said capillary tubes and said metering ampoules containing said perfusion fluid and said calibrating solution,

a third part consisting of said at least one drug metering ampoule respectively insertable into one of said receiving positions of said housing, which is connectable to one of said capillary tubes in said replacement unit, and

a fourth part comprising said subcutaneous needle attachable to said replacement unit, said subcutaneous needle being connected with said master capillary.

5. A device according to claim 4, wherein said pumping and suction unit means is configured as a plunger pump located in said housing together with a drive mechanism of said plunger pump, a plunger chamber of said plunger pump being connected with said master capillary in said replacement unit by means of a coupling.

6. A device according to claim 5, wherein a valve means for ventilation of said master capillary is provided next to said pumping and suction unit means, said valve means being controlled by said microprocessor.

7. A device according to claim 6 wherein said ventilation valve means comprises a movable element which can be shifted between two extreme positions by means of an electromagnet, thus connecting said pumping and suction unit means to said subcutaneous needle through said master capillary in one extreme position, and to the ambient air in the other extreme position of said movable element.

8. A device according to claim 7, wherein said movable element of said ventilation valve means and at least one electromagnet actuating said movable element are placed in said housing.

9. A device according to claim 4, wherein said pumping and suction unit means is configured as a peristaltic pump located in said housing together with a drive mechanism of said peristaltic pump, one end of a tube or said peristaltic pump being connected to said master capillary in said replacement unit by means of a coupling, and the other end of said tube being connected to an opening to the ambient air, said opening being covered by a filter.

10. A device according to claim 4, wherein said drive unit means comprises a microprocessor-controlled motor with gear for each of said metering ampoules and driving rods actuating said metering plungers in said ampoules.

11. A device according to claim 4, for determining the concentration of glucose and for the automatic administration of insulin, wherein said sensing unit means is provided with sensor means of measuring glucose concentration and the conductivity of the perfusion fluid, and wherein metering ampoules are provided for regular insulin or NPH insulin.

12. A device according to claim 1, for determining the concentration of glucose and for the automatic administration of insulin, wherein said sensing unit means is provided with sensor means for measuring glucose concentration and the conductivity of the perfusion fluid, and wherein metering ampoules are provided for regular insulin or NPH insulin.

13. A device according to claim 1, wherein said drive unit means comprises a microprocessor-controlled motor with gear for each of said metering ampoules and driving rods actuating said metering plungers in said ampoules.