Blood coagulation test system

• US 5,339,830 A
• Filed: 01/21/1992
• Issued: 08/23/1994
• Est. Priority Date: 01/21/1992
• Status: Expired due to Fees

• Current Assignee: Joseph W. Blake III
• Original Assignee: Joseph W. Blake III
• Inventors: Blake, Joseph W. III
• Primary Examiner(s): Alexander, Lyle A.
• Assistant Examiner(s): WALLENHORST, MAUREEN
• Application Number:
  US07/822,724
• Time in Patent Office: 945 Days
• Field of Search: 422/73, 422/82.13, 422/68.1, 436/69, 436/70, 73/64.41, 128/638, 128/771, 604/211, 604/224
• US Class Current: 600/584
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150992 Blood sampling from a fluid line external to a patient, such as a catheter line, combined with an infusion line; blood sampling from indwelling needle sets, e.g. sealable ports, luer couplings, valves tubing connectors and couplings A61M39/00
• CPC Class Codes: G01N 33/4905 Determining clotting time of blood by chemical methods G01N33/86, C12Q1/54

Abstract

A blood coagulation test system for in vitro assessment of blood characteristics including hemostasis, thrombus formation, thrombolysis, and collagen platelet interaction includes a syringe/test cartridge for collection, testing and disposal of the sample together with a test analyser for executing the test protocol. Coagulation functions are evaluated by establishing controlled bleeding of the sample from a capillary tube within the cartridge and monitoring these blood characteristics as a function of blood pressure variations occurring in the cartridge as the test proceeds. The blood sample remains within the cartridge for testing and after disposal.

Claims

1. A blood coagulation test system comprising a test cartridge and a test analyser for receiving the test cartridge and for executing a blood analysis protocol,

the test cartridge having a cylinder defining a collection chamber, a first opening at one end of the cylinder for receiving a blood sample into the chamber, means for capping the first opening of the cylinder, a second opening at the other end of the cylinder, a plunger telescoped into the cylinder through the second opening for drawing a blood sample into the chamber through the first opening, the plunger being an elongate hollow tube having a bleeding receptacle and a waste compartment, a capillary tube extending through the plunger and forming a blood flow path from the collection chamber past the bleeding receptacle and into the waste compartment, a port in the capillary tube for bleeding the blood sample into the bleeding receptacle, means interconnecting the collection chamber and the plunger for moving the plunger at a steady rate for drawing a blood sample into the collection chamber and for expelling the sample from the chamber to establish blood flow through the capillary tube, a pressure piston forming part of the cartridge and being telescoped into the waste compartment and together with the waste compartment defining a waste chamber for receiving waste blood from the capillary tube, the pressure piston being adapted to apply a constant back pressure on blood in the waste chamber,

the test analyser having means for maintaining the cartridge at constant temperature, means for driving the interconnecting means for telescoping the plunger into the collection chamber thereby expelling the blood sample therefrom and establishing blood flow through the capillary tube at a steady rate, means engaging the cartridge for sensing the pressure of blood flowing within the cartridge, means engaging the pressure piston for applying a back pressure on the blood in the waste chamber, and means for recording pressure variation of blood pressure within the cartridge while the blood sample flows through the capillary tube into the waste chamber.

2. A cartridge for blood coagulation tests comprising a cylinder defining a collection chamber, a first opening at one end of the cylinder for collecting a blood sample, a second opening through the other end of the cylinder, a plunger telescoped into the cylinder through the second opening for drawing a blood sample into the chamber, the plunger having a bleeding receptacle and a waste compartment having an interior wall, a capillary tube forming a blood flow path from the collection chamber past the bleeding receptacle and into the waste compartment, a port in the capillary tube for bleeding the blood sample into the bleeding receptacle, means interconnecting the collection chamber and the plunger for moving the plunger at a steady rate for drawing a blood sample into the collection chamber and for expelling the sample from the chamber to establish blood flow through the capillary tube, and means for applying a constant back pressure on blood in the waste compartment, so that blood flows through the capillary tube at a steady flow rate.

3. A cartridge as defined in claim 2 having a nozzle defining the first opening of the cylinder.

4. A cartridge as defined in claim 3 having a closure cap securing the nozzle.

5. A cartridge as defined in claim 3 having a collection cap and intravenous tube fitted to the nozzle.

6. A cartridge as defined in claim 3 having a pressure diaphragm closure fitted to the nozzle.

7. A cartridge as defined in claim 2 in which the plunger moving means includes a threaded exterior surface about the plunger and a threaded drive sleeve affixed to the cylinder near the second opening which is in driving engagement with the threaded surface of the plunger.

8. A cartridge as defined in claim 2 in which the back pressure means comprises a piston fitted into the waste compartment for defining the waste compartment and exerting a predetermined pressure on waste blood in the compartment.

9. A cartridge as defined in claim 8 in which the waste compartment and the collection chamber are substantially the same diameter so that forward movement of the plunger produces equal rearward movement of the piston and the overall length of the cartridge remains substantially constant as blood is expelled from the collection chamber into the capillary tube and waste compartment.

10. A cartridge as defined in claim 2 which further includes means for closing the first opening of the cylinder whereby the blood sample is entirely contained within the cartridge from collection to disposal of the cartridge at the conclusion of a test.

11. A cartridge as defined in claim 2 in which the capillary tube forms part of the plunger and has a front end extending into the collection chamber, and means fitted to the front end for providing a fluid tight seal within the chamber.

12. A cartridge as defined in claim 2 in which the constant back pressure means includes means for sealing the interior wall of the waste compartment in a fluid tight manner.

13. A cartridge as defined in claim 2 which includes a small amount of blood additive in the collection chamber for assessing modification to characteristics of a blood sample.

14. A cartridge as defined in claim 2 in which the blood flow path allows a low volume blood sample of about 2 ml to be analyzed thereby quickly achieving complete test results.

15. A test cartridge comprising a collection chamber having an inlet for receiving a blood sample, a plunger telescoped into the collection chamber for drawing a blood sample through the inlet into the chamber, a bleeding receptacle, a waste compartment, means defining a fluid path extending through the plunger and interconnecting the collection chamber, bleeding receptacle and waste compartment, the plunger being adapted to apply pressure to the blood sample in the collection chamber for establishing sample flow from the collection chamber through the fluid path to the waste compartment, a port in the fluid path for establishing bleeding of the sample into the bleeding receptacle, means for applying back pressure to the blood sample entering the waste compartment, and means for transmitting interior collection chamber blood pressure to the cartridge exterior.

16. A test cartridge as defined in claim 15 in which the means for transmitting interior collection chamber blood pressure also closes the collection chamber inlet.

17. A test cartridge as defined in claim 16 in which the means for closing the collection chamber inlet and transmitting interior collection chamber blood pressure comprises a pressure diaphragm closure cap applied to the chamber inlet.

18. A test cartridge as defined in claim 15 in which the fluid path, the bleeding receptacle, and the waste compartment form part of the plunger telescoping into the collection chamber.

19. A test cartridge as defined in claim 18 in which the part of the plunger telescoping into the collection chamber is provided with a screw thread and in which the collection chamber further comprises a threaded drive sleeve that interconnects with the screw thread on the plunger for enabling steady rate telescoping movement therebetween.

20. A test cartridge as defined in claim 15 in which the means for applying back pressure to the blood sample entering the waste compartment comprises a piston slidably mounted in the waste compartment for applying a given counterweight force and constant pressure to the blood sample.

21. A test cartridge as defined in claim 15 in which the port in the fluid path induces platelet plug formation in the port during bleeding of the blood sample into the bleeding receptacle thereby causing a gradual rise in sample blood pressure in the cartridge and providing an index of hemostasis of the blood sample.

22. A test cartridge as defined in claim 21 in which the fluid path induces thrombus formation thereby causing a further gradual rise in sample blood pressure in the cartridge providing an index of thrombosis of the blood sample.

23. A test cartridge as defined in claim 22 in which the means for applying back pressure to the blood sample entering the waste compartment maintains the blood pressure in the cartridge at a predetermined level after thrombosis occurs thereby providing an index of thrombolysis of the blood sample.

24. A test cartridge as defined in claim 15 which further includes collegen exposed to the blood sample through the port to provide an index of platelet collagen interaction by a measurement of rising blood pressure of the sample in the test cartridge.

25. A cartridge for blood coagulation tests comprising a cylinder defining a collection chamber, a first opening at one end of the cylinder for collecting a blood sample, a second opening through the other end of the cylinder, a plunger telescoped into the cylinder through the second opening for drawing a blood sample into the chamber, the plunger having a bleeding receptacle and a waste compartment, means defining a blood flow path from the collection chamber past the bleeding receptacle and into the waste compartment, and a port in the blood flow path for bleeding into the bleeding receptacle, wherein the plunger serves to expel the blood sample from the chamber to establish blood flow through the blood flow path.

26. A cartridge as defined in claim 25 in which the blood flow path for the blood sample from the collection chamber to the waste compartment allows a low volume blood sample of about 2 ml to be analyzed thereby quickly achieving complete test results.

27. A cartridge for blood coagulation tests comprising a cylinder defining a collection chamber, a first opening at one end of the cylinder for collecting a blood sample, a second opening through the other end of the cylinder, a plunger telescoped into the cylinder through the second opening for drawing a blood sample into the chamber, the plunger having a bleeding receptacle and a waste compartment, a capillary tube extending through the plunger and forming a blood flow path from the collection chamber past the bleeding receptacle and into the waste compartment, an aperture in the capillary tube for bleeding the blood sample into the bleeding receptacle, the aperture being formed during manufacture of the cartridge and having precise dimensions and contour, the plunger being adapted for drawing a blood sample into the collection chamber and for expelling the sample from the chamber to establish blood flow through the capillary tube and the aperture, and means for applying a constant back pressure on blood in the waste compartment, so that the blood flows through the capillary tube and the aperture at steady flow rates.

28. A cartridge for blood coagulation tests comprising a cylinder defining a collection chamber, a nozzle at one end of the cylinder for accommodating a fill connection for the flow of blood into the collection chamber, a second opening through the other end of the cylinder, a plunger telescoped into the cylinder through the second opening for drawing a blood sample into the chamber, the plunger being of tubular form and divided longitudinally by a lateral bulkhead into a bleeding receptacle and a waste compartment, the bleeding receptacle defined by a front plunger wall, a forward portion of the plunger, and the lateral bulkhead, the waste compartment defined by the lateral bulkhead, an aft portion of the plunger and an open read end, a capillary tube projecting forwardly from the front plunger wall into the collection chamber and extending through the plunger and forming a blood flow path from the collection chamber past the bleeding receptacle and into the waste compartment, a sealing ring about the forward projection of the capillary tube for forming a fluid tight seal with the collection chamber, an aperture in the capillary tube for bleeding the blood sample into the bleeding receptacle, the forward portion of the plunger having a threaded exterior surface, a drive ring rotatably affixed to the collection chamber near the second opening in engagement with the threaded exterior surface of the plunger for moving the plunger at a steady rate for drawing a blood sample into the collection chamber and for expelling the sample from the chamber to establish blood flow through the capillary tube, a pressure diaphragm closing the nozzle, a pressure piston telescoped into the waste compartment through the open end thereof for applying a constant back pressure on blood entering the waste compartment so that blood flows through the capillary tube at a steady flow rate, and a seal fitted to the pressure piston for forming a fluid tight seal between the piston and the waste compartment.

29. A test analyser for a test cartridge having a collection chamber for collecting a blood sample through a fill opening, a plunger telescoped into the collection chamber through a second opening for drawing a blood sample into the chamber, the plunger having a capillary tube extending therethrough and a waste compartment, a drive sleeve affixed to the collection chamber near the second opening and in driving engagement with the plunger to draw a blood sample into the collection chamber and to expel the sample from the chamber through the capillary tube and into the waste compartment, and a back pressure piston in the waste compartment, the analyser comprising means for maintaining the cartridge at constant temperature, means for engaging the drive sleeve affixed to the collection chamber for driving the plunger into the collection chamber thereby establishing blood flow through the capillary tube and into the waste compartment at a steady rate, means engaging the fill opening for sensing the pressure of blood flowing within the cartridge, means for applying a constant force on the back pressure piston for applying a back pressure on the blood flow entering the waste compartment, and means for recording pressure variation of blood pressure within the cartridge thereby providing an assessment of blood characteristics.

30. A test analyser as defined in claim 29 in which the means for maintaining the cartridge at constant temperature surrounds the the collection chamber.

31. A test analyser as defined in claim 29 which further includes a preheater for test cartridges.

32. A method of testing blood comprising the steps of drawing a blood sample from a patient through a nozzle into a cylinder by a first stroke of a piston telescoped into the cylinder, closing the nozzle with a cap, applying pressure to the blood sample in the cylinder by a return stroke of the piston into the cylinder thereby establishing flow of the blood sample from the cylinder through a capillary tube having a standard preformed aperture and into a waste compartment both formed within the piston, applying a constant back pressure on the blood sample in the waste compartment to maintain the flow through the capillary tube at an established control pressure, diverting a portion of pressurized blood sample flow from the capillary tube through the aperture, and determining one or more blood characteristics by observing variation in blood pressure within the cylinder.

33. A method as defined in claim 32 which further includes the step of maintaining the temperature of the blood sample at 37 deg. C. for each step of the method and in which the established control pressure is 60 mm Hg.

34. A method as defined in claim 32 which further includes the step of preheating the cylinder, piston, capillary tube, and waste compartment to a temperature of 37 degrees centigrade before drawing a blood sample from a patient.

35. A method as defined in claim 32 in which blood characteristics for hemostasis, thrombus, and thrombolysis are sequentially determined.

36. A method as defined in claim 32 which further includes the step of placing collagen at the aperture for assessing collagen platelet interaction of the blood sample.