Sensor apparatus for use in measuring a parameter of a fluid sample

• US 5,932,175 A
• Filed: 09/25/1996
• Issued: 08/03/1999
• Est. Priority Date: 09/25/1996
• Status: Expired due to Fees

• Current Assignee: Segars California Partners, LP
• Original Assignee: VIA Medical Corporation (Medtronic Plc)
• Inventors: Del Toro, Alfonso, Carlisle, Thomas J., Knute, deceased, Wallace L., Lucisano, Joseph Y., Wong, David K.
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US08/719,489
• Time in Patent Office: 1,042 Days
• Field of Search: 422/82.01, 204/415, 204/192.17
• US Class Current: 422/82.01
• CPC Class Codes: G01N 27/3271 Amperometric enzyme electrodes for analytes in body fluids, e.g. glucose in blood amperometry per se G01N27/49; aspects concerning the enzyme reagent C12Q1/001

Abstract

An improved sensor apparatus of a kind that positions a semi-permeable membrane adjacent to an electrode assembly, for measuring a predetermined parameter, e.g., glucose concentration, of an adjacent fluid sample. A special compressible ring serves a first function of tensioning the membrane so that it is maintained in intimate contact with the electrode assembly, and it further serves a second function of sealing the fluid sample from the external environment.

Claims

1. Sensor apparatus for use in measuring a predetermined parameter of a fluid sample, comprising:

a body defining a chamber for carrying the fluid sample;

a ring disposed in the body, the ring defining an opening adjacent to the chamber;

a semi-permeable membrane disposed across the opening defined in the ring; and

an electrode assembly incorporating one or more electrically conductive electrodes, at least a portion of the electrode assembly being positioned in the opening defined in the ring, in intimate contact with the membrane;

wherein the membrane separates the electrode assembly from the fluid sample in the chamber;

and wherein the ring is configured both to tension the membrane and thereby ensure its intimate contact with the electrode assembly, and to seal the chamber and thereby prevent the escape of the fluid sample.

2. Sensor apparatus as defined in claim 1, wherein:

the ring has at least limited compressibility, and the opening defined in the ring is substantially circular and centrally located; and

the electrode assembly includes a substantially cylindrical projection sized to fit in the ring opening, the cylindrical projection having a convex surface that engages and further tensions the membrane.

3. Sensor apparatus as defined in claim 2, wherein the ring includes an annular irregularity that provides the seal that prevents the escape of the fluid sample from the chamber.

4. Sensor apparatus as defined in claim 3, wherein:

the annular irregularity of the ring is an annular protrusion facing the electrode assembly and having a substantially uniform height;

the electrode assembly includes an annular shoulder encircling the substantially cylindrical projection and including an annular recess sized and configured to receive the annular protrusion of the ring;

the membrane is disposed on the side of the ring facing the electrode assembly, radially inward of the annular protrusion; and

the annular protrusion of the ring and the annular recess of the electrode assembly cooperate to provide the seal that prevents the escape of the fluid sample from the chamber.

5. Sensor apparatus as defined in claim 3, wherein the ring has a unitary structure and is formed of a material selected from the group consisting of silicone rubber and soft polyurethane.

6. Sensor apparatus as defined in claim 2, wherein:

the ring includes an annular recess facing away from the electrode assembly and having a substantially uniform depth;

the body includes an annular protrusion sized and configured to be received by the annular recess defined in the ring;

the membrane is disposed on the side of the ring facing away from the electrode assembly; and

the annular recess of the ring and the annular protrusion of the body cooperate to tension the membrane and ensure its intimate contact with the electrode assembly.

7. Sensor apparatus as defined in claim 2, wherein:

the body includes a wall that defines a cavity sized to receive the ring with a press-fit; and

the opening of the ring is sized to receive the cylindrical projection of the electrode assembly with a press-fit.

8. Sensor apparatus as defined in claim 7, wherein the ring has a unitary structure and is formed of a material selected from the group consisting of hard polyurethane, polycarbonate and acrylic.

9. Sensor apparatus as defined in claim 2, wherein:

the body includes a wall that defines a substantially cylindrical cavity sized to receive the ring with a press-fit; and

the sensor apparatus further includes a mechanism for compressing the electrode assembly against the ring, to provide the seal that prevents the escape of the fluid sample from the chamber.

10. Sensor apparatus as defined in claim 1, wherein:

the body includes a cylindrical wall that defines a cavity sized to receive the electrode assembly;

the electrode assembly further includes an outer, cylindrical wall that defines an annular recess; and

the sensor apparatus further includes an O-ring disposed in the annular recess defined in the cylindrical wall of the electrode assembly, to cooperate with the cylindrical wall defined in the body, to provide a further seal that prevents the escape of the fluid sample from the chamber.

11. Sensor apparatus as defined in claim 1, wherein:

the sensor apparatus is used to measure the concentration of glucose in the fluid sample; and

the semi-permeable membrane incorporates glucose oxidase.

12. Sensor apparatus as defined in claim 1, wherein the electrode assembly includes:

a first electrode and an associated electrical lead, both formed of a first precious metal; and

a second electrode and an associated electrical lead, both formed of a second precious metal.

13. Sensor apparatus for use in measuring a predetermined parameter of a fluid sample, comprising:

a body defining a chamber for carrying the fluid sample;

an electrode assembly that carries one or more electrically conductive electrodes;

a ring disposed in the body, adjacent to the chamber, the ring defining an opening; and

a semi-permeable membrane disposed across the opening defined in the ring;

wherein the electrode assembly is sized to fit through the opening defined in the ring, to engage and tension the membrane, the tensioned membrane intimately contacting the electrode assembly and separating the electrode assembly from the fluid sample in the chamber;

and wherein the ring is configured to provide a seal in a region radially beyond the tensioned membrane, to prevent the escape of the fluid sample from the chamber.

14. Sensor apparatus as defined in claim 13, wherein:

the ring has at least limited compressibility, and the opening defined in the compressible ring is substantially circular and centrally located; and

the electrode assembly includes a substantially cylindrical projection sized to fit in the opening defined by the compressible ring, the cylindrical projection having a convex surface that engages and tensions the membrane.

15. Sensor apparatus as defined in claim 14, wherein the compressible ring includes an annular irregularity that provides the seal that prevents the escape of the fluid sample from the chamber.

16. Sensor apparatus as defined in claim 15, wherein:

the annular irregularity of the compressible ring is an annular protrusion facing the electrode assembly and having a substantially uniform height;

the electrode assembly includes an annular shoulder encircling the substantially cylindrical projection and including an annular recess sized and configured to receive the annular protrusion of the compressible ring;

the membrane is disposed on the side of the compressible ring facing the electrode assembly; and

the annular protrusion of the compressible ring and the annular recess of the electrode assembly cooperate to provide the seal that prevents the escape of the fluid sample from the chamber.

17. Sensor apparatus as defined in claim 15, wherein the compressible ring has a unitary structure and is formed of a material selected from the group consisting of silicone rubber and soft polyurethane.

18. Sensor apparatus as defined in claim 14, wherein:

the ring includes an annular recess facing away from the electrode assembly and having a substantially uniform depth;

the body includes an annular protrusion sized and configured to be received by the annular recess defined in the compressible ring;

the membrane is disposed on the side of the compressible ring facing away from the electrode assembly, radially inward of the annular recess; and

the annular recess of the compressible ring and the annular protrusion of the body cooperate to tension the membrane and ensure its intimate contact with the electrode assembly.

19. Sensor apparatus as defined in claim 14, wherein:

the body includes a wall that defines a cavity sized to receive the compressible ring with a press-fit; and

the opening of the compressible ring is sized to receive the cylindrical projection of the electrode assembly with a press-fit.

20. Sensor apparatus as defined in claim 19, wherein the ring has a unitary structure and is formed of a material selected from the group consisting of hard polyurethane, polycarbonate and acrylic.

21. Sensor apparatus as defined in claim 14, wherein:

the body includes a wall that defines a substantially cylindrical cavity sized to receive the ring with a press-fit; and

the sensor apparatus further includes a mechanism for compressing the electrode assembly against the ring, to provide the seal that prevents the escape of the fluid sample from the chamber.

22. Sensor apparatus as defined in claim 14, wherein:

the body includes a cylindrical wall that defines a cavity sized to receive the electrode assembly;

the electrode assembly further includes an outer, cylindrical wall that defines an annular recess; and

the sensor apparatus further includes an O-ring disposed in the annular recess defined in the cylindrical wall of the electrode assembly, to cooperate with the cylindrical wall defined in the body, to provide a further seal that prevents the escape of the fluid sample from the chamber.

23. Sensor apparatus as defined in claim 13, wherein:

the sensor apparatus is used to measure the concentration of glucose in the fluid sample; and

the semi-permeable membrane incorporates glucose oxidase.

24. Sensor apparatus as defined in claim 13, wherein the electrode assembly includes:

a first electrode and an associated electrical lead, both formed of a first precious metal; and

a second electrode and an associated electrical lead, both formed of a second precious metal.

25. Sensor apparatus for measuring the concentration of glucose in a fluid sample, comprising:

a body having a wall that defines a generally cylindrical cavity, with a depression at one end of the cavity defining a passageway for carrying the fluid sample;

an elastomeric ring, of unitary construction, disposed in the body cavity, the ring defining a circular opening disposed adjacent to the passageway, and the ring further defining an annular protrusion around its periphery, the protrusion having a substantially uniform height;

a semi-permeable membrane disposed across the ring opening, radially inward of the annular protrusion;

an electrode assembly incorporating one or more electrically conductive electrodes, the electrode assembly including a substantially cylindrical projection sized to fit in the ring opening, and further including an annular shoulder encircling the cylindrical projection and defining an annular recess sized and configured to conformably receive the annular protrusion of the ring;

wherein the cylindrical projection of the electrode assembly defines a convex surface; and

a mechanism for compressing the electrode assembly against the elastomeric ring, such that the convex surface of the electrode assembly engages and intimately contacts the membrane, the membrane separating the electrode assembly from the fluid sample in the passageway, and such that the ring is deformed radially outwardly to engage the body wall, to seal the chamber and thereby prevent the escape of the fluid sample from the chamber.