One-way evacuated tube stopper

• US 4,134,512 A
• Filed: 06/08/1977
• Issued: 01/16/1979
• Est. Priority Date: 06/08/1977
• Status: Expired due to Term

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Nugent, Edward L.
• Primary Examiner(s): Wolk, Morris O.
• Assistant Examiner(s): Turk, Arnold
• Application Number:
  US05/804,502
• Time in Patent Office: 587 Days
• Field of Search: 128/2 F, 128/2 G, 128/215, 128/297, 128/350 V, 128/DIG. 5, 215/260, 215/270, 215/247, 23/292
• US Class Current: 215/247
• CPC Class Codes: A61B 5/15003 for venous or arterial blood
• CPC Class Codes: A61B 5/150221 Valves
• CPC Class Codes: A61B 5/150251 Collection chamber divided into at least two compartments, e.g. for division of samples injection syringes having more than one chamber A61M5/19; syringes for injection of two or more media A61M5/2448, A61M5/284; sample preparation for further analysis A61B5/150755
• CPC Class Codes: A61B 5/150351 Caps, stoppers or lids for sealing or closing a blood collection vessel or container, e.g. a test-tube or syringe barrel caps for bottles or containers in general B65D41/00
• CPC Class Codes: A61B 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150496 Details of construction of hub, i.e. element used to attach the double-ended needle to a piercing device or sampling device
• 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 5/154 Devices using pre-evacuated means
• CPC Class Codes: B01L 3/50825 Closing or opening means, corks, bungs closures for containers B65D; means for removing stoppers B67B7/02

Abstract

Stopper for an evacuated tube with an open end for collecting fluid such as blood samples. The stopper includes a plug adapted to be mounted in the opening in the tube so as to normally seal the tube. The plug permits access of a fluid sample needle therethrough into fluid communication with the reduced pressure interior of the tube so that fluid is collected in the tube from the needle. A check valve is on the plug to automatically open when the needle is inserted through the plug and subjected to the reduced pressure in the tube and to automatically close when subjected to a predetermined amount of pressure from within the tube such as that caused by backflow thereby preventing any fluid passing into the needle from the tube. The check valve includes a chamber which can be used as a reagent holder prior to the tube use.

Claims

1. A stopper adapted for removable mounting in an evacuated tube having an open end for collecting blood samples, the stopper comprising;

a plug adapted to be mounted in the open end of an evacuated tube so as to normally seal the open end of the tube, the plug having means thereon puncturable by a sample needle to permit access of a blood sample needle therethrough into fluid communication with the evacuated interior of the tube so that blood is collected in the tube from the needle, a normally closed check valve on the plug capable of automatically opening when the needle is inserted through the plug and is subjected to the reduced pressure in the tube and automatically closing when subjected to a predetermined amount of pressure from within the tube such as that caused by backflow thereby preventing any fluid passing into the needle from the tube, the check valve having surfaces thereon cooperating with surfaces on the plug to form a sealed interior chamber therebetween when the valve is closed, and the chamber being positioned to be capable of housing the end of the needle when the needle is inserted through the plug to thereby facilitate operation of the valve in controlling flow into and out of the needle.

2. The invention in accordance with claim 1 wherein the plug is constructed of a material that automatically reseals the tube after the needle has been removed therefrom.

3. The invention in accordance with claim 1 wherein the plug is formed of a self-sealing, elastomeric, puncturable material.

4. The invention in accordance with claim 1 wherein the plug contains means to be frictionally mounted in the open end of the tube.

5. The invention in accordance with claim 1 wherein the plug is formed of natural rubber.

6. The invention in accordance with claim 1 wherein said sealed interior chamber is adapted to contain reagent material positioned so that upon introduction of blood from the needle and opening of the check valve, the blood will mix with the reagent and be introduced simultaneously into the tube therewith.

7. The invention in accordance with claim 1 wherein the check valve is a valve member formed of self-sealing elastomeric material and including two adjacent resilient flaps normally resting against one another in the closed position at one end on the check valve, the check valve having a passageway therethrough and being open at the other end whereby pressure from the open end will separate the flaps opening the valve and forming a passageway therethrough, and removal of the pressure or a greater pressure from the one end of the valve will permit the two flaps to come together into the normal closed position so that fluid is free to flow in one direction through the valve but is not permitted to flow in the other direction through the valve.

8. The invention in accordance with claim 7 wherein the plug has an enlarged head portion and a tubularly-shaped hollow body portiion extending from the head portion, the adjoining surfaces of the body portion and the head portion forming a shoulder adapted to be seated against the rim on the open end of a tube with the body portion inserted in the tube and in frictional engagement with the side walls of the tube, the body portion of the plug containing a central recess extending inwardly from the end opposite to the head and terminating in an annular receiving recess of larger diameter, the check valve being mounted in the recess with a rim portion at the open end of the valve seated in the larger recess adjacent the head of the plug and the flaps extending toward the end of the plug distal from the head beyond the open end of the plug so that the valve is captured within the body portion of the plug and positioning the valve so that when the plug is placed in interengagement with the tube the valve will extend beyond the end of the body of the plug into the tube.

9. A fluid sample collection container comprising;

an evacuated tube having an open end, a stopper mounted in the open end of the tube, the stopper including a plug mounted in the opening in the tube so as to normally seal the tube, the plug having means thereon puncturable by a sample needle to permit access of a fluid sample needle therethrough into fluid communication with the reduced pressure interior of the tube so that fluid is collected in the tube from the needle, a normally closed check valve on the plug capable of automatically opening when the needle is inserted through the plug and subjected to the reduced pressure in the tube and automatically closing when subjected to a predetermined amount of pressure from within the tube such as that caused by backflow thereby preventing any fluid passing into the needle from the tube, the check valve having surfaces thereon cooperating with surfaces on the plug to form a sealed interior chamber therebetween when the valve is closed, and the chamber being positioned to be capable of housing the end of the needle when the needle is inserted through the plug to thereby facilitate operation of the valve in controlling flow into and out of the needle.

10. The invention in accordance with claim 9 wherein the plug is constructed of a material that automatically reseals the tube when the needle is removed therefrom.

11. The invention in accordance with claim 9 wherein the plug is in the form of self-sealing, elastomeric, puncturable material.

12. The invention in accordance with claim 9 wherein the plug contains means for frictionally mounting the plug on the open end of the tube.

13. The invention in accordance with claim 9 wherein the plug is formed of natural rubber.

14. The invention in accordance with claim 9 wherein said sealed interior chamber is adapted to contain reagent material positioned so that upon introduction of blood from the needle and opening of the check valve, the blood will mix with the reagent and be introduced simultaneously into the tube therewith.

15. The invention in accordance with claim 9 wherein the check valve is a valve member formed of self-sealing elastomeric material and including two adjacent resilient flaps normally resting against one another in the closed position at one end on the check valve, the check valve having a passageway therethrough and being open at the other end whereby pressure from the open end will separate the flaps opening the valve and forming a passageway therethrough, and removal of the pressure or a greater pressure from the one end of the valve will permit the two flaps to come together into the normally closed position so that fluid is free to flow in one direction through the valve but is not permitted to flow in the other direction through the valve.

16. The invention in accordance with claim 15 wherein the plug has an enlarged head portion and a tubularly-shaped hollow body portion extending from the head portion, the adjoining surfaces of the body portion and the head portion forming a shoulder seated against the rim on the open end of a tube with the body portion inserted in the tube and in frictional engagement with the side walls of the tube, the body portion of the plug containing a central recess extending inwardly from the end opposite to the head and terminating in an annular receiving recess of larger diameter, the check valve being mounted in the recess with a rim portion at the open end of the valve seated in the larger recess adjacent the head of the plug and the flaps extending toward the end of the plug distal from the head beyond the open end of the plug thereby capturing the valve within the body portion of the plug and positioning the valve so that when the plug is placed in interengagement with the tube the valve will extend beyond the end of the body of the plug into the tube.