Gas flow cartridge with improved coagulation detection and expanded analytical test capability

• US 4,534,939 A
• Filed: 10/15/1982
• Issued: 08/13/1985
• Est. Priority Date: 10/15/1982
• Status: Expired due to Term

• Current Assignee: Hemotec Incorporated
• Original Assignee: Hemotec Incorporated
• Inventors: Smith, Leland B., Jackson, Jacqueline J.
• Primary Examiner(s): Richman, Barry S.
• Assistant Examiner(s): Carrier, Joseph P.
• Application Number:
  US06/434,558
• Time in Patent Office: 1,033 Days
• Field of Search: 422/100-103, 422/57, 422/58, 422/61, 422/73, 422/119, 422/44, 436/69, 436/165, 436/809, 73/64.1, 73/57, 435/13, 210/918, 356/39
• US Class Current: 422/430
• CPC Class Codes: G01N 33/4905 Determining clotting time of blood by chemical methods G01N33/86, C12Q1/54
• CPC Class Codes: G01N 33/86 involving blood coagulating time or factors, or their receptors

Abstract

A gas flow cartridge includes a tube-like member which defines a reaction chamber in which a pool of liquid is subjected to an analytical test. A coating of debubbling agent is applied to an area of the tube-like member above the reaction chamber. The debubbling agent collapses bubbles of noncoagulated fluid but allows bubbles of coagulated fluid to continue an upward movement above the area where the coating is applied. Coagulation is detected by sensing the coagulated bubbles moving upward in the tube-like member. A quantity of activator agent is initially confined with the reaction chamber, preferably within a structure defined by a segment of paper-like material formed into an activator retaining form. The paper-like material unrolls or unfolds during the analytical test.

Claims

1. In a cartridge defining a reaction chamber in which to hold a pool of blood or a blood derivative during a coagulation analytical test, a reagent chamber to hold a liquid reagent, means separating the reaction chamber and the reagent chamber, and means for intercommunication of the reaction chamber and the reagent chamber, an improvement comprising:

means containing a pre-determined quantity of activator agent within the reaction chamber said means being designed to release the activator agent into the blood or the blood derivative when the reaction chamber is intercommunicated with the reagent chamber to intermix the reagent with the pool of blood or the blood derivative.

2. A cartridge as defined in claim 1 wherein said reaction chamber is part of an upwardly extending tube-like member for receiving the liquid pool and wherein an area of the interior surface of the tube-like member located above the reaction chamber is coated with a debubbling agent, the coated area of debubbling agent operative to collapse bubbles of noncoagulated fluid and prevent the bubbles of noncoagulated fluid from moving past the coated area, and the coated area being ineffective on bubbles of coagulated fluid.

3. A cartridge as defined in claim 1 wherein said cartridge is an upwardly extending tube-like member which defines the reaction chamber and receives the liquid pool and further including means for admitting gas flowing upwardly through the liquid pool in the reaction chamber to create bubbles and to transport liquid in the bubbles through the tube-like member above the pool and the reaction chamber, and wherein said means containing the predetermined quantity of activator agent includes a flat segment of fibrous paper-like material which is initially formed into a cup-like structure for containing the quantity of activator agent, and further comprising means attaching the cup-like structure to the tube-like member at a position adjacent the lower portion of the reaction chamber.

4. A cartridge as defined in claim 3 wherein the segment of fibrous paper-like material is adapted to open from the cup-like form under the influence of the liquid in the reaction chamber and the flow of gas through the pool of liquid.

6. In a gas flow cartridge having an upward extending tube-like member defining a reaction chamber in which to hold a pool of fluid during a coagulation analytical test, and means for admitting gas flowing upward through the liquid pool to transport liquid in bubbles from the pool above the reaction chamber upward through a hollow interior of the tube-like member, an improvement comprising:

a coating of debubbling agent applied to the interior of the tube-like member at a location above the reaction chamber and over an area extending completely around the periphery of the interior to circumscribe a substantially unobstructed center opening in the hollow interior through which bubbles of fluid may pass, the coating of debubbling agent being effective on contact with noncoagulated fluid in the bubbles to collapse all the bubbles of noncoagulated fluid within the center opening and reflow the noncoagulated fluid downward into the pool in the reaction chamber and prevent the upward movement of bubbles of non-coagulated fluid through the center opening, the coating of debubbling agent further being ineffective on coagulated fluid in the bubbles to allow the bubbles of coagulated fluid to continue upward through the center opening.

5. A cartridge as defined in claim 9 and further of the type having a partition extending across the open interior of the tube-like member at the bottom of the reaction chamber, the partition including a break-out portion, and wherein the paper-like material operatively snags or holds the break-out portion after it is broken out of the partition.

7. A cartridge as defined in claim 6 in combination with transmitting means for directing a light beam within the tube-like member in the area where the debubbling agent has been applied, the light beam being of the type having characteristics which are modified by bubbles of liquid intersecting the beam, and receiving means for receiving the modified light beam after it emerges from within the tube-like member in the area where the debubbling agent has been applied and for detecting modifications of the light beam caused by bubbles of coagulated fluid passing through the area where the debubbling agent has been applied.

8. A cartridge as defined in claim 6 in combination with optical sensor means for sensing the presence of bubbles of coagulated fluid in the tube-like member within the area where the debubbling agent has been applied.

9. A cartridge as defined in claim 6 further comprising a quantity of activator agent retained in the reaction chamber.

10. A cartridge as defined in claim 6 and further of the type having a reagent chamber within the tube-like member below the reaction chamber, and wherein the reagent chamber initially confines therein a quantity of an activator agent.

11. A cartridge as defined in claim 6 and further of the type having a housing of which the tube-like member is a part, and wherein the housing includes a shelf portion from which the tube-like member extends downward, and at least one notch formed in a side of the shelf portion defining a code indicative of the type of analytical test to be conducted with the cartridge.

12. A cartridge as defined in claim 6 in combination with transmitting means for directing a light beam within the hollow interior, the light beam being of the type having characteristics which are modified by bubbles of liquid intersecting the beam, the light beam passing within the hollow interior of said tube-like member at a predetermined position relative to the coating to detect bubbles of coagulated fluid rising through the center opening circumscribed by said coating, and receiving means for receiving the light beam and for detecting modifications of the light beam caused by bubbles of coagulated fluid passing through the center opening.

13. A cartridge as defined in claim 6 in combination with optical sensor means for sensing the presence of bubbles of coagulated fluid in the tube-like member rising through the center opening.

14. A cartridge as defined in claim 6 and further of the type comprising means located at the upper end of the hollow interior for collecting coagulated fluid transported thereto by bubbles rising through the hollow interior, and wherein the coating is located intermediate the reaction chamber and the coagulated fluid collecting means.

15. A cartridge as defined in claim 6 further comprising an enclosure containing a quantity of activating agent, and means for retaining the enclosure to the tube-like member within the reaction chamber.

16. A cartridge as defined in claim 15 wherein the enclosure is substantially defined by a paper-like material, and the paper-like material is attached to the tube-like member within the reaction chamber.

17. A cartridge as defined in claim 16 wherein the paper-like material is initially in a cup-shaped form, and the paper-like material opens from the cup-shaped form after insertion of the fluid sample in the reaction chamber and flowing of gas through the pool of fluid.

18. A cartridge as defined in claim 17 and further of the type having a partition extending across the open interior of the tube-like member at the bottom of the reaction chamber, the partition including a break-out portion, and wherein the paper-like material operatively snags or holds the break-out portion after it is broken out of the partition, the paper-like material having sufficient wet strength to avoid tearing under the influence of gas passing thereover while holding the break-out portion during the test.

19. A cartridge as defined in claim 18 and further of the type having a reagent chamber within the tube-like member below the partition and a lower plug member movably received within the tube-like member and sealing the lower end of the reaction chamber, the lower plug member initially spaced from the partition to define a predetermined volume within the reagent chamber for containing reagent chamber contents therein, the plug-like member having a dome portion defining a selectively openable and closable slit therethrough, the break-out portion of the partition having a pin extending downwardly therefrom and adapted to be contacted by the plug member as the plug member is moved upwardly in the reagent chamber to break out the break-out portion, the upward movement of the plug member also forcing the contents of the reagent chamber into the reaction chamber by reducing the predetermined volume.

20. A cartridge as defined in claim 19 wherein the activator agent is one of a particulate or chemical activator.

21. In a gas flow cartridge having an upward extending tube-like member and a partition extending across the open interior of the tube-like member to define a reaction chamber and a reagent chamber within the interior of the tube-like member which are respectively above and below the partition, means associated with the partition for initially sealing an opening through the partition and for selectively thereafter being removed to provide fluid communication through the partition between the reaction and reagent chambers, the reaction chamber operatively holding a pool of liquid during a coagulation analytical test, and means for admitting gas flowing upward through the liquid pool in the reaction chamber to create bubbles and to transport liquid in bubbles through the tube-like member above the pool and reaction chamber, and an improvement comprising a segment of fibrous material formed into a predetermined structure and attached to the tube-like member within the reaction chamber at a position adjacent the partition, the fibrous material adapted to open from the initial structural form and snag or hold the initial sealing means after being selectively removed from the partition.

22. A cartridge as defined in claim 21 wherein the initial sealing means includes a break-out portion of the partition which is broken out and separated from the remaining part of the partition to form the opening through the partition.

23. A cartridge as defined in claim 21 wherein the initial structure of the fibrous material retains therein a predetermined quantity of activator agent.

24. A cartridge as defined in claim 23 wherein an area of the interior surface of the tube-like member located above the reaction chamber is coated with debubbling agent.

25. A cartridge as defined in claim 24 wherein the coated area of debubbling agent is operative to collapse bubbles of noncoagulated fluid and prevent the bubbles of noncoagulated fluid from moving past the coated area, and the coated area being ineffective on bubbles of coagulated fluid.