CA1148430A

CA1148430A - Blood sampler

Info

Publication number: CA1148430A
Application number: CA000348929A
Authority: CA
Inventors: David S. Akhavi
Original assignee: David S. Akhavi; American Hospital Supply Corporation; Baxter International Inc.; Allegiance Corporation
Current assignee: Allegiance Corp
Priority date: 1979-04-02
Filing date: 1980-04-01
Publication date: 1983-06-21
Also published as: EP0026213A1; EP0026213A4; US4266559A; EP0047806A1; US4385637A; WO1980002106A1

Abstract

BLOOD SAMPLER

ABSTRACT OF THE DISCLOSURE

A device particularly suited for collecting and dispensing an arterial blood sample. A needle is connected to a flexible transparent tube that includes an air exit vent with a nonwet filter so air, but not blood, can exit the vent under arterial blood pressure. A special needle adapter prevents formation of air bubbles, and a baffle system in the needle minimizes blood and air mixing. A clamp on the reservoir pinches off an air contaminated blood segment and can longitudinally strip a different blood segment which is not air contaminated. The tubular reservoir has an oxygen blocking coating, and its internal surface includes a dry anticoagulant coating.

Description

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BACKGROUND

Venous blood has long been collected for various medical tests.
Recently, it has become more important to ~lso collect arterial blood for measuring of the par~ial pressures of dissolved oxygen and carbon dioxide in thearterial system.

When co~lecting a blood sample, it is important to distinguish at the time of collection whether it is arterial or venous blood. In the past, arterialblood has been detected by use of glass syringes in which the arterial blood pressure would be sufficient to force back the syringe plunger; venous pressure would not. Patent 3,930,429 also proposes u plastic syringe system for . distinguishing arterial pressureO However with plunger type arterial blood collectors, these plungers can sometimes catch and drag, making it difficult to clearly distinguish that the blood is arterial.

Recently, others have proposed the use of a glass tube eonnected to a needle, thereby eliminating the plunger. Such device reequired the use of a manually applied cork to plug the rear end of the glass tube to prevent the blood sample from spilling out. Because the glass tube was rigid, it was also difficult to dispense the blood sample into a machine that did not have a vacuum extractor for the blood sample. Because it did not have a plunger, such sample could not be forced into the machine.

Additional problems with prior arterial blood samplers have included transmission o~ oxygen through the sampler's wall to cause erroneous readings on the blood~ and liquid heparin in the sampler which introduced an error into the readings for oxygen and carbon dioxide. These problems are described in 25 the following publications:

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-2 -Scott et al, "Leakage of Oxygen Yrom Blood and Water Samples Stored in Plastic and Glass Syringes," British Medical Journal, 28 August 1971, 3, pp. 512-516.
Hansen et al, "A Systematic ~rror in the Determination of Blood Pco ," American Review of Respiratory Disease, Vol. 115, 1977~ pp.
10612-1063.
Hamilton et al, "Arterial Blood Gas Analysis: Potential Errors Due to Addition of Heparin," Anaesthesia and Intensive Care, Vol. VI, No. 3, August 1978, pp. 251-255.

SUMMAf~Y OF THE INVENTION

~ The present invention overcomes the problems described above and ; includes a blood sampler with a needle connected to a flexible reservoir tube having a vent closed by a valve structure which permits the expulsion of gas from the reservoir, but not blood. A needle adapter with a special beveled construction prevents the formation of air bubbles during collection of a blood sample, and a baffle structure in the needle prevents turbulent mixing of blood and its overriding air as the blood fills the reservoir. A clamp on the flexibletube segments the collected sample into an air contaminated segment and a test segment, and this clamp can strip the colleeted blood sample from the reservoir into a testing machine that does not have a vacuum sample extractor.
The flexible tube has a gas blocking coating to prevent transmission of oxygen or carbon dioxide through the tube's wall. The tube also has an internal coatingof dry anticoagulant.

TEIE DRAWINGS
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Figure 1 is a front elevational view of the blood sampler partially filled with the blood sample;
` ' Figure 2 is a view similar to Figure 1 with the sampler filled with the blood sample;

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;~ Figure 3 is an enlarged sectional view of the needle adapter and showing an alternate form of the vent structure;

Figure 4 is a view of the packaged sarnpler;

Figure 5 is an enlarged view taken along line 5-5 of Figure 3;

Figure 6 is an enlarged view of the first baffle structure taken along line 6-6 of Figure 3;
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` Figure 7 is a view of the sampler connected with the testing machine.

:~ Figure 8 is a fragmentary view showing a second baffle structure in the form of a ball.
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DETAILED DESCRIPTION

In Figure 1, a needle including a cannula 1 is shown inserted into a patient to tap arterial blood 2. The needle includes a hub 3 which is attached by means of a needle adapter 4 to a transparent flexible plastic tube 5 forming a blood eollection reservoir. This plastic tube 5 can be of a thermoplastic or ~`; thermoset material which has elastomeric or rubber like properties so it can be pinched shut and reopened upon removal of the pinching forces. In Figure 1, blood is shown welling up in the reservoir tube by means of arterial blood pressure and forcing the overriding air 6 out through vent 7. Vent 7 includes a one-way valve structure 8 in the form of a "nonwet" filter. Such filter will permit the passge of gas, such as sterile air, from the reservoir, but will not permit the passage of blood.

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The details of a first embodiment of the vent and nonwet filter structure of Figure 1 is shown in detail in Figure 2. In Figure 2, the complete , .

''' blood sample has been collected and a clamp 10 has been positioned along the ~ reservoir 5 and the fle2~ible tube is pinched shut by clamp 10 to segregate the - collected blood sample into an air contaminated segment 11 and a test segment 12. Thus, any change in the oxygen or carbon dioxide partial pressure of the blood caused by its contact with air is minimized by segmenting sample 11 from the test machine. With a blood sampler, it is customary to stick the needle intoa rubber plug (not shown) to prevent leakage. If desired, the rubber plug could be inside a needle protector 13. An alternative way of containing the sample is to remove the needle and place a syringe cap (not shown) on a tip of the syringe.

As previously mentioned, it is important to minimize the turbulent contact with the blood sample and air, particularly when the sample taken is arterial blood in which the partial pressure of oxygen and carbon dioxide are to be measuredu In Figure 3, the needle adapter has a special structure for minimizing air bubble hangups when co~lecting the sample. The needle adapter

4 has a tubular structure with an internally beveled lower end 15 and an internally beveled upper end 16. Tests have shown that such structure causes the blood sample to smoothly well up in the collecting reservoir. For instance, when end 15 was at 90 to the longitudinal axis of the adapter, air bubbles continuously formed at such intersection of the needle adapter and hub 3.

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The needle hub 3 is firmly held to the needle adapter by an internally threaded collar 17. The needle hub also includes a structure which prevents the turbulent mixing of the blood sample and air, particularly during an inrush of arterial blood. The needle hub of ~igure 3 is shown with a first baffle structure 19 that can be snap fitted into an undercut groove 20 in the hub, or press fitted into a hub without undercut, or otherwise secured to the hub. Preferably, the baffle structure as shown in Figure 6 has one or more openings, such as 22 and 23, which combine to form a passage at least as large as an internal diameter of cannula 1. By such large passage to the baffle .

structure, the inflow of blood from an arterial source is not sufficiently slowed down so as to be confused with venous blood under a much lower pressure. The baffle system is not intended to be a high pressure drop filtering system which might so restrict the flow of blood that it would take an inordinate amount of time to collect the sample.

The baffle of Figure 6 includes a peripheral ring 24 which is bridged by a central bar 25. If desired for molding purposes, an enlarged central section 26 can be added for a mold gate. An alternative Iorm of a baffle, shown in Figure 8, is a ball in the needle that can prevent turbulent blood and air mixing 10 and yet does not interfere with the flow rate distinction between arterial and venous blood.

In the second embodiment of the vent structure shown at 30 of Figure 3, an internally tapered extension 31 is provided. Extension 31 can receive a hypodermic syringe if it is desired not to use the clamp 10, but to 15 force the blood sample out of the reservoir into the testing machine. Such ;; extension 31 could also be used with a syringe to apply a vacuum to the reservoir for collecting slow flowing venous or arterial blood.
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Once the blood sarnple has been collected, the proteetor and needle can be removed and the needle adapter joined directly to a testing machine 36 20 to measure the partial pressure of oxygen and carbon dioxide in the arterial blood sample. Most such testing machines include a very small tubular probe that fits inside the reservoir and sucks out a measured amount of blood for the test.

In some machines that do not have such an automatic vacuum extractor, a clamp can be used to manually strip the blood sample into the machine. This can be done either by sliding a clamp, such as schematically shown at 10, along the tube. Alternatively, a roller type clamp, such as schematically shown at 37, could be used to roll along the flexible tube 4~

reservoir. When a clamp such as 10 is used for sliding, it is preferable to coat the outer surface of the tube or internal surface of the clamp with a lubricant, sueh as silicone or a teflon coating shown at 38 in Figure 5.

., It has been found that a reservoir 5 of polyurethane remains flexible

5 and highly squeezable even when subjected to ice bath storage at 0 C. This flexibility is useful in expelling the sample and also rolling the tube in the hands ` to remix any separated plasma and hemoglobin prior to testing. Such rolling feature also helps to mix the blood with an anticoagulant. ~nother material ~ that remains flexible and squeezable is a blank copolymer, marketed under the 10 trademark KRATON, by Shell Chemical Company. However, KRATON does not ^ work as well as polyurethane because of its more limited transparency and more ; tacky external surface making it more difficult to slide a clamp, such as clamp 10. Preferably, the tubular reservoir has a Shore A hardness of 40 to 100.

As mentioned in the publications above, it is highly critical to 15 minimize any transmission of oxygen or carbon dioxide across the reservoir wall 5. Because polyurethane is somewhat pervious to oxygen and carbon dioxide, an internal gas blocking barrier coating or layer 39 is applied to the inner surface of the polyurethane reservoir. This blocking coating which prevents trans-mission of oxygen and carbon dioxide can be a copolymer of vinylidene chloride 20 and acrylonitrile, which is also known under the trademark SARAN.

This gas blocking coating is further covered with a dry anticoagulant40, such as heparin. Because the heparin is in dry form, it has very little geometric volume to substantially change the partial pressure of oxygen or carbon dioxide in the blood to cause errors.

Figure 4 shoYvs the blood sampler in a package 41 which preferably maintains the sampler in sterile condition until ready to use. The package can then be opened and the sannpler is extremely useful for collecting and dispensing an arterial blood sample. However, it can also be useful in collectin~

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a venous blood sample, but the inflow of blood would be much slower unless a vacuum were applied by syringe to the Figure 3 embodiment.
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The blood eollecting reservoir can have an internal diameter of 100 to .300 inch, a wall thickness of .010 to .100 inch, and a length of 2 to 12 inches for an adult blood sample. A smaller diameter tube could be used for collecting a blood sample from an infant.

In the above description, specific examples have been used to describe the invention. However, it is understood by those skilled in the art that certain modifications can be made to these examples without departing from the spirit and scope of the invention.

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Claims

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. An arterial blood sampler comprising: a needle; a blood reservoir with an inlet connected to the needle and having a gas therein, which reservoir has an outlet of sufficient size for passage of at least a portion of such gas through the outlet in response to arterial blood pressure; valve means on the outlet let preventing the escape of arterial blood from the reservoir;
and segmenting means for closing the reservoir between the reservoir's inlet and outlet to segment a collected blood sample.

2. An arterial blood sampler as set forth in Claim 1, wherein the valve means includes a filter permitting the passage of gas but not blood.

3. An arterial blood sampler as set forth in Claim 1, wherein the gas in the reservoir is sterile air.

4. An arterial blood sampler as set forth in Claim 1, wherein the reservoir is transparent for visually distinguishing between the flow rates of venous and arterial blood.

5. An arterial blood sampler as set forth in Claim 1, wherein the reservoir is an elongated tube.

6. An arterial blood sampler as set forth in Claim 5, wherein the tube is transparent.

7. An arterial blood sampler as set forth in Claim 5, wherein the tube is flexible.

8. An arterial blood sampler as set forth in Claim 5, wherein the tube is compressible with lateral force, but sufficiently resilient to reopen upon release of such lateral compressive force.

9. An arterial blood sampler as set forth in Claim 5, in which the segmenting means is a stripper clamp on the tube.

10. An arterial blood sampler as set forth in Claim 5, wherein the tube has an internal diameter of .100 to .300 inch.

11. An arterial blood sampler as set forth in Claim 5, wherein the tube has a wall thickness of from .010 to .100 inch.

12. An arterial blood sampler as set forth in Claim 5, wherein the tube is from 2 to 12 inches long.

13. An arterial blood sampler as set forth in Claim 1, wherein the sampler has a baffle to disperse inrushing blood.

14. An arterial blood sampler as set forth in Claim 13, wherein the needle has a hub, and the baffle is in the hub.

15. An arterial blood sampler as set forth in Claim 14, wherein the hub has an internal groove into which the baffle fits.

16. An arterial blood sampler as set forth in Claim 1, wherein the sampler has a removable protector on the needle.

17. An arterial blood sampler as set forth in Claim 1, wherein the sampler is sterile and in a protective package.

18. An arterial blood sampler as set forth in Claim 1, wherein the reservoir is of a material pervious to blood gas, and this reservoir has a coating that is substantially impervious to blood gas to reduce error in laboratory tests on collected blood.

19. An arterial blood sampler as set forth in Claim 1, wherein the reservoir is sufficiently flexible at 0°C to be readily compressed to expel blood immediately after removal of the sampler from an ice bath.

20. An arterial blood sampler as set forth in Claim 19, wherein the reservoir is of polyurethane.

21. An arterial blood sampler as set forth in Claim 20, wherein at least one surface of the reservoir is coated with a copolymer of vinylidene chloride and acrylonitrile.

22. An arterial blood sampler as set forth in Claim 21, wherein only the inner surface of the reservoir is coated with a copolymer of vinylidene chloride and acrylonitrile.

23. An arterial blood sampler as set forth in Claim 1, wherein the reservoir's inner surface is coated with dry heparin, whereby heparin error is substantially eliminated.

24. An arterial blood sampler as set forth in Claim 1 wherein the reservoir is connected to a needle adapter.

25. An arterial blood sampler as set forth in Claim 24, wherein the adapter has a tubular section that extends inside the reservoir and a hub of the needle, and the tubular section has internally beveled ends so as to reduce turbulance of blood flowing into the sampler.

26. An arterial blood sampler as set forth in Claim 24, wherein the needle adapter has a threaded collar for securing the needle to the adapter.

27. A blood sampler comprising: a needle; a blood reservoir with an inlet connected to the needle and having a gas therein, which reservoir has an outlet of sufficient size for passage of at least a portion of such gas through the outlet in response to pressure of blood entering the reservoir; valve means on the outlet preventing the escape of blood from the reservoir; and segmenting means for closing the reservoir between the reser-voir's inlet and outlet to segment a collected blood sample.

28. A blood sampler as set forth in Claim 27, wherein said reservoir is of a flexible plastic material pervious to blood gas and has a blocking coating on at least one surface of the reservoir, which blocking coating is substantially impervious to blood gas transfer.

29. A blood sampler as set forth in Claim 28, wherein the reservoir is of polyurethane, and the blocking coating is a copolymer of vinylidene chloride and acrylonitrile.

30. A blood sampler as set forth in Claim 29, wherein the coated reservoir has a Shore hardness of from 40 to 100.

31. A blood sampler as set forth in Claim 27, wherein the needle has a hub and a baffle in the needle hub to dispose incoming blood.

32. A blood sampler as set forth in Claim 31, wherein the baffle includes a peripheral ring and a transverse bar diamet-rically joining opposite sides of the ring, which baffle can disperse incoming blood without substantially slowing blood flow.

33. A blood sampler as set forth in Claim 29, wherein the needle has a cannula and a baffle having one or more openings that combine to form a passage at least as large as the cannula so as not to substantially restrict blood flow.

34. For use in the blood sampler of Claim 33, a needle com-prising: a hub; a cannula attached to the hub; and a baffle in the hub, said baffle having one or More openings that combine to form a passage at least as large as the cannula's internal diameter so as not to substantially restrict blood flow.

35. A needle as set forth in Claim 34, wherein the baffle includes a peripheral ring and a transverse bar diametrically joining opposite sides of the ring.

36. A needle as set forth in Claim 34, wherein the hub has an internal groove for retaining the baffle.

37. A needle as set forth in Claim 34, wherein the baffle is a ball.