Sterile loop calibration system

• US 5,057,278 A
• Filed: 04/26/1990
• Issued: 10/15/1991
• Est. Priority Date: 04/26/1990
• Status: Expired due to Fees

• Current Assignee: Terumo Cardiovascular Systems Corporation (Terumo Corporation)
• Original Assignee: Minnesota Mining and Manufacturing Co (3M Company)
• Inventors: Maxwell, Thomas P., Hacker, Thomas G.
• Primary Examiner(s): NOT, DEFINED
• Assistant Examiner(s): Trembley, Theresa A.
• Application Number:
  US07/514,704
• Time in Patent Office: 537 Days
• Field of Search: 422/63, 422/82.12, 422/102, 422/103, 422/81, 422/68.1, 417/476, 417/477, 604/151, 604/65, 604/67, 128/DIG. 12, 128/DIG. 13, 436/8, 436/11
• US Class Current: 422/81
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: B01F 25/4522 the components being pressed through porous bodies, e.g. flat plates, blocks or cylinders, which obstruct the whole diameter of the tube B01F25/45243 takes precedence
• CPC Class Codes: G01N 27/4163 checking the operation of, or calibrating, the measuring apparatus G01N27/3274, G01N27/4175 and G01N33/0006 take precedence
• CPC Class Codes: G01N 27/4165 for pH meters
• CPC Class Codes: Y10S 128/12 Pressure infusion
• CPC Class Codes: Y10S 128/13 Infusion monitoring
• 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

Abstract

An endless path calibration system comprising a sensor cassette having a flow-through passage and at least one sensor to be calibrated, a chamber coupled to the sensor cassette to define an endless path and a sterile calibration liquid in the endless path. A gas injection passage for injecting gas into the sterile calibration liquid and a gas vent leading from the endless path to the exterior of the endless path. A check valve allows gas to escape from the endless path and substantially prevents gas and liquid from entering the endless path through the gas vent.

Claims

1. A sterile-loop calibration system comprising:

a sensor cassette having a flow-through passage and including at least one sensor to be calibrated, said sensor being responsive to a characteristic of a gas;

means defining a chamber;

means including said flow-through passage and said chamber for defining a closed, endless loop;

a sterile calibration liquid in said endless loop, said endless loop providing an endless path for circulation of the sterile calibration liquid whereby no calibration liquid is added to the endless loop and substantially little or no calibration liquid is drained from the endless loop during operation;

a gas injection passage through which a gas can be injected into the sterile calibration liquid in said endless loop;

means in said endless loop for mixing the gas and the sterile calibration liquid whereby the sterile calibration liquid and the gas can be circulated through the endless loop to thereby permit calibration of the sensor; and

a gas vent leading from said endless loop to the exterior of the endless loop.

2. A system as defined in claim 1 including gas sterilizing filter means in communication with the gas injection passage for sterilizing the gas injected into the loop.

3. A system as defined in claim 1 wherein said mixing means includes said chamber.

4. A system as defined in claim 3 wherein said chamber includes a divider which divides said chamber into a sparging chamber section and settling chamber section, and said gas vent terminates in said settling chamber section.

5. A system as defined in claim 4 including a baffle adjacent the divider and in the sparging chamber section for breaking up bubbles in the sterile calibration liquid.

6. A system as defined in claim 1 wherein the loop is configured to change the direction of flow of the sterile calibration liquid at one location and the gas is directed into the loop substantially at said one location.

7. A system as defined in claim 1 including a pump for circulating the sterile calibration liquid in the loop.

8. A system as defined in claim 7 wherein the pump has an inlet and an outlet, said mixing means includes said chamber and the chamber has an inlet and an outlet, and the gas injection passage introduces the gas into the sterile calibration liquid between the inlet to the chamber and the pump outlet.

9. A system as defined in claim 1 wherein the gas vent includes a restricted orifice.

10. A system as defined in claim 1 including means in the gas vent for allowing gas to escape from the loop and to substantially prevent gas from entering the loop through the gas vent.

11. A sterile-loop calibration system comprising:

a sensor cassette having a flow-through passage and including at least one sensor to be calibrated, said flow-through passage having first and second ends;

a calibration housing having an inlet, an outlet, and a liquid passage extending through the housing from the inlet to the outlet;

conduit means for coupling the first and second ends of the flow-through passage of the sensor cassette to the inlet and outlet, respectively, of the housing to form a loop which provides an endless path;

said liquid passage including a chamber;

said housing having a gas injection passage leading to a location in said liquid passage for injecting gas into the liquid passage and means for closing said gas injection passage; and

said housing including a gas vent leading from said chamber to the exterior of said housing.

12. A sterile-loop calibration system as defined in claim 11 wherein said loop is a closed, endless loop and wherein no liquid is added to the endless loop and substantially little or no liquid is drained from the endless loop during operation of the system.

13. A system as defined in claim 11 including gas sterilizing filter means in communication with the gas injection passage for sterilizing the gas injected into the liquid passage.

14. A system as defined in claim 11 wherein said chamber includes a weir which divides said chamber into a sparging chamber section and settling chamber section, and said gas vent terminates in said settling chamber section.

15. A system as defined in claim 13 including a baffle in the sparging chamber.

16. A system as defined in claim 11 including passage means including portions of the liquid passage and the gas injection passage for forming a tee at said location in said housing.

17. A system as defined in claim 11 including pumping means including a region of the liquid passage for circulating a sterile calibration liquid through the endless path.

18. A system as defined in claim 16 wherein said location in the liquid passage is between said region of the liquid passage and the chamber and the chamber is between said location in the liquid passage and the outlet of the housing.

19. A system as defined in claim 11 wherein the liquid passage includes an outlet passage section leading to the outlet of the housing and the housing has a temperature well adapted to receive a temperature probe in heat exchange relationship with the outlet passage section.

20. A system as defined in claim 11 including a sterile calibration liquid in said loop.

21. A system as defined in claim 19 including gas sterilizing filter means in communication with the gas injection passage for sterilizing the gas injected into the liquid passage, said chamber includes a divider which divides said chamber into a sparging chamber section and a settling chamber, and said gas vent terminates in said settling chamber section.

22. A system as defined in claim 20 including passage means including portions of the liquid passage and the gas injection passage forming a tee at said location in said housing.

23. A system as defined in claim 20 including pumping means including a region of the liquid passage for circulating the sterile calibration liquid.

24. A system as defined in claim 11 wherein the gas vent includes a restricted orifice.

25. A system as defined in claim 11 including means in the gas vent for allowing gas to escape from the chamber and to substantially prevent gas from entering the chamber through the gas vent.

26. A system as defined in claim 11 wherein the liquid passage includes a radially compressible tube having a tube passage and an annular, deformable flange at one end of the tube and integral with the tube, said flange having outer and inner faces, said housing includes a first member having an opening and a flange supporting face surrounding said opening, said outer face engaging said flange supporting face with said opening being in registry with said tube passage to form a juncture of the passage and the opening, and said housing includes a tube receiving structure receiving said tube and coupled to the first member and including means defining an annular projection engaging said inner face of said flange, said annular projection being radially narrower than the inner face of the flange and providing high-unit loading of the flange to deform the flange, said annular projection urging the flange tightly against the supporting face to provide a fluid-tight seal around the juncture of the tube passage and the opening.

28. An apparatus as defined in claim 26 wherein the seal construction includes an annular deformable flange at one end of the tube and integral with the tube, said flange having outer and inner faces, said housing includes a first member having an opening at one end of the first passage section and a flange supporting face surrounding said opening, said outer face engaging said flange supporting face with said opening being in registry with said tube to form a juncture of the tube and the opening, said housing includes a tube receiving structure receiving said tube and coupled to the first member and including means defining an annular projection engaging said inner face of said flange, said annular projection being radially narrower than the inner face of the flange and providing high-unit loading of the flange to deform the flange, said annular projection urging the flange tightly against the supporting face to provide a fluid-tight seal around the juncture of the tube and the opening.

29. An apparatus as defined in claim 26 wherein the seal construction includes an annular, deformable flange at one end of the tube and integral with the tube, said housing having a surface surrounding one end of the first passage section and including a rigid ring, said flange being between the surface and the ring and said housing includes means contacting said ring around less than 360 degrees to squeeze the flange between the ring and the surface.

27. An apparatus comprising:

a housing having an inlet, an outlet, and a passage extending through the housing between the inlet and the outlet, said passage including first and second passage sections;

a curved wall surface on the housing;

a tube compressor;

said housing including a compressible tube carried by said housing and defining a portion of said passage between the first and second passage sections, said tube being between the curved wall surface and the tube compressor and being wrapped in a circumferential direction at least part way around the tube compressor;

means for mounting the tube compressor on the housing for movement relative to the curved wall to squeeze the tube in a zone which moves along the tube to thereby pump fluid in the tube;

said tube having opposite end portions which extend generally tangentially of the tube compressor and then generally axially of the tube compressor to their respective ends; and

means for sealing the ends of the tube to the first and second passage sections, respectively.

30. A method of calibrating a sensor of a sensor cassette of the type having a flow-through passage comprising:

pumping a sterile calibration liquid through a closed, endless path which includes the flow-through passage, whereby no calibration liquid is added to the endless path and substantially little or no calibration liquid is drained from the endless path during said pumping step;

injecting a sterile gas into the endless path to create a pressure in the endless path which is greater than ambient;

mixing the gas with the sterile calibration liquid in the endless path to control the partial pressure of at least a component of said gas in the sterile calibration liquid;

venting at least some of the gas from the endless path; and

exposing the sensor to the sterile calibration liquid having the controlled partial pressure of said component of said gas whereby the sensor can be calibrated.

34. A sterile-loop calibration system comprising:

a sensor cassette having a flow-through passage and including at least one sensor to be calibrated, said sensor being responsive to a characteristic of a gas;

means defining a chamber, said chamber comprising a sparging chamber section and a settling chamber section;

means including said flow-through passage and said chamber for defining a loop;

a sterile calibration liquid in said loop, said loop providing an endless path for circulation of the sterile calibration liquid;

a gas injection passage through which a gas can be injected into the sterile calibration liquid in said loop;

means in said loop for mixing the gas and the sterile calibration liquid whereby the sterile calibration liquid and the gas can be circulated through the loop to thereby permit calibration of the sensor, said mixing means including said chamber; and

a gas vent leading from said settling chamber section to the exterior of the loop.

35. A system as defined in claim 37 including a divider which divides said sparging chamber section and said settling chamber section, and a baffle adjacent the divider and in the sparging chamber section for breaking up bubbles in the sterile calibration liquid.

31. A method of claim 33 wherein the step of injecting includes passing nonsterile gas through a sterilizing filter to provide the sterile gas.

32. A method as defined in claim 33 wherein said step of mixing includes passing the gas and sterile calibration liquid through a region in said endless path of increased volume.

33. A method as defined in claim 35 wherein the gas is injected into the endless path and then passed to said region of increased volume.