MXPA98001956A - Set to collect blood or other fluids corpora - Google Patents

Abstract

The present invention relates to an assembly for collecting or collecting blood or other body fluids. The assembly includes an elongated tube having an open end and a closed end. The open end includes threads. An internally threaded plastic cap is mounted on the open end of the tube. The cap includes an axial passage and a resealable member aligned with the axial passage. A gas impermeable member is attached to the resealable member and the open end of the tube. Both, the resealable member and gas impermeable member can be pierced by a needle. The lid is removable with the gas impermeable member as a unit due to the fact that the bond between the gas impermeable member and the tube is weaker than that between the gas impermeable member and the resealable member. The cap includes a deflectable portion near its upper end to couple the walls of a tube holder, and to function as a shock absorber if the tube is dropped.

Description

SET TO COLLECT BLOOD OR OTHER BODY FLUIDS BACKGROUND OF THE INVENTION 1. Field of the Invention The field of the invention relates to assemblies for collecting blood or other bodily fluids, the assemblies being of the type that includes a container or container having a plug assembly pierceable by a needle or cannula. 2. Description of Related Art Blood collection tubes are commonly used by doctors, nurses and others to draw a sample of a body fluid from a patient or to receive a sample of fluid from another container. These tubes are ordinarily evacuated, and include a pierceable plug. During typical use of a blood collection tube, one end of a double-ended needle assembly is used to pierce a vein. The evacuated blood collection tube is then propelled towards the second end of the double ended needle assembly until its closure is punctured. The blood in this way is attracted to the tube. The double-ended needle assembly is ordinarily mounted to a fastener having a tubular body. The blood collection tube is inserted into the tubular body in order to couple the second end of the double ended needle assembly. Maintaining a vacuum inside the blood collection tube is important. The blood collection tubes can be stored for considerable periods of time before they are used. The loss of vacuum during storage or at any time would make collection tubes less effective or useless. A number of designs of blood collection tubes and their plugs have been the subject of patents and other exposures. British Patent Specification 1 388 494 and the US Patent. No. 4,327,746, both describe closures for said tubes having seal membranes positioned between a lid and the open end of the collection tube. The Patent of E.U.A. No. 5,061,263 discloses various closure designs, each including a cap, a gas barrier member and a newly sealable member. The Patents of E.U.A. Nos. 4,150,666, 4,967,919, 4,991,601, 5,326,534, 5,494,170 and International Publication No. WO 81/01238 describe various blood collection tubes and / or fasteners for said tubes. The 5,494,170 patent discloses a cap having flexible tabs that couple the wall of the fastener, thereby maintaining the blood collection tube within the fastener.

SUMMARY OF THE INVENTION The present invention provides a body fluid collection assembly that is capable of maintaining a vacuum for a prolonged period of time, is easily penetrable by a needle, and includes a closure assembly that is both easily removed as It is easily reinstalled. It is also provided with a novel closure assembly for a body fluid collection tube. An assembly according to the invention includes an elongate, generally cylindrical container having a closed end and an open end. A closure assembly is detachably mounted to the open end of the container, preferably by interengaging threads. The closure assembly includes a lid and a newly sealable member secured to the lid. The lid includes an opening to allow access to the interior of the container. The resealable or newly sealable member covers this opening. A gas barrier member, which may be comprised of a thin sheet of metal, is attached to the open end of the container and to the closure assembly. The bond between the gas barrier member and the container is weaker than that between the gas barrier member and the closure assembly. This allows the gas barrier member to separate with the closure assembly from the open end of the container without suffering noticeable damage. Both the newly sealable member and the gas barrier member are penetrable by a needle, the resealable member providing a seal substantially impervious to liquid during withdrawal of the needle. The cover of the invention preferably includes a deflectable portion at the upper end thereof. The deflectable portion must be designed to attach a flat surface if the container is placed horizontally on said surface. This allows the divertable portion to function as a shock absorbing system that will help retain the bond between the gas barrier and the container, in case the container is dropped. It also provides a superior interference fit when the container is inserted into the tube holder. The open end of the container preferably includes external threads, interrupted. The lid preferably includes a plurality of internal threads. each of which includes a front portion. Internal tabs adjacent to each of the front portions are provided to enable the user to easily place the lid for new application to the open end of the container. Preferred threads allow the lid to be separated at less than 180a rotation so that said removal can be achieved using only one hand.

BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a perspective view of an assembly for collecting body fluids and a tube holder capable of receiving a portion of the assembly; Figure 2 is a top perspective view showing the assembly having an end portion positioned within the tube holder; Figure 3 is a sectional elevation view showing the assembly for collecting bodily fluids and the tube holder; Figure 4 is a sectional elevation view showing the assembly positioned within the tube holder; Figure 5 is an enlarged sectional view showing the assembly fully inserted into the tube holder; Figure 6 is a perspective, detailed view of the assembly for collecting bodily fluids; Figure 7 is a top plan view of a cover of the assembly for collecting body fluids; Figure 8 is a bottom plan view thereof; and Figure 9 is a bottom perspective view thereof.

DETAILED DESCRIPTION OF THE INVENTION By means of the invention, a set 10 is provided for collecting blood or other bodily fluids. Referring to Figures 1-6, the assembly includes a generally cylindrical container 12 having a closed end and an open end, and a closure assembly 14 that can be detachably mounted to the open end of the container. As shown in Figures 1-5, the container can be used in conjunction with a fastener to which a double-ended needle assembly 18 is mounted. The container 12 is preferably transparent, and is preferably made of a material that is substantially impervious to gas, such as glass or polyethylene terephthalate (PET). As shown in Figure 6, the container includes an interrupted thread including three thread segments 20. Each thread segment has a first end portion adjacent the edge and a second end portion spirally downwardly with respect to the first end portion. A space separates each thread segment. The depth of the interrupted thread shown in the drawings is less than about 1.78 millimeters. The closure assembly 14 is illustrated more clearly in Figures 5 and 7. It includes a generally cylindrical lid 22 made of polypropylene or other semi-rigid polyolefin material and a newly sealable or resealable member 24. The resealable member is made from an elastomeric material such as polyurethane, or alternatively, butyl rubber, which is capable of resealing itself after piercing thereof by a needle and subsequent removal of the needle. The lid 22 includes an upper portion 22A and a lower portion 22B. An annular shoulder 25 is defined by the lower surface of the upper portion of the lid. The upper portion of the lid further includes a portion 26 of annular body, substantially rigid, surrounded by an annular portion 28, desirable. The deflectable portion 28 is comprised of a plurality of arcuate walls 28A separated by slots 28B extending downwardly from the upper edge of the deflectable portion. The external surface of the cap includes a plurality of elongated protuberances 30, which extend radially. These protrusions facilitate the handling of the cover and assembly 10. They also provide contact surfaces in case the assembly is dropped. In this way force is imparted to the deflectable portion 28 of the cap. The body portion 26 of the upper portion of the cap includes a chamfered upper surface 26a, which may include indications such as opening and closing instructions. An annular wall 32 is positioned inwardly of the body portion 26. The inner surface of this annular wall 32 defines an axial opening 34 that extends through the upper portion of the cap. The lower portion 22B of the cap 22 is defined by a substantially cylindrical wall 36 that includes a plurality of internal threads 38. . In the embodiment shown herein, three spiral threads are provided, each having a leading thread adjacent to a positioning tab 40. (See Figure 9). The positioning tabs extend axially towards the bottom of the lid. The width of each tongue is less than the width of each space separating the external thread segments 20 from the container 12. Each thread 38 extends spirally in 180s or less, preferably approximately 120-1402. This allows the lid 22 to be mounted to or detached from the container by rotating 180a or less. This task does not ordinarily require a person with two hands. The lid can alternatively be snapped onto the container. This particularity facilitates the manufacturing process. The positioning tabs facilitate the new threading of the lid towards the container after its initial removal. The resealable member 24 is shown in the drawings as a flat disc. This particular configuration is not critical, even though a relatively thin central portion facilitates penetration of the needle. The member 24 is secured to the shoulder 25, thereby closing the opening 34 through the upper portion of the lid 22. Hot melt adhesive 42 or other suitable adhesive may be used to permanently secure the resealable member to the lid. A gas barrier member 44 is secured to the resealable member 24 by a tie layer 46 of adhesive material or a material such as PET. The gas barrier member is also attached to the upper portion of the container, and preferably the edge, by a seal layer 48 which may also be PET. (See Figures 5 and 6). A seal layer that allows induction sealing is preferred. It should be understood that the drawings of the resealable member, gas barrier member and other sealing members are not to scale. The gas barrier member is preferably a thin sheet of metal, such as thin aluminum sheet, which has a thickness of approximately 0.03 millimeters. Tie and seal layers 46, 48 may be coatings on the gas barrier member. The assembly 10 as described above can be used with a fastener 16 as shown in the drawings or other fasteners known in the art. As shown in Figure 4, the assembly 10 is used to collect blood or other body fluid when it is inserted into the holder so that the rear end of the double-ended needle assembly 18 extends through the resealable member 24 and the gas barrier member 44. The figures show a cover 50 which is displaced during the insertion of the assembly 10 towards the fastener. The use of said cover is not required. The assembly 10 is provided to users in the manner shown in Figures 1 and 3. The container 12 is ordinarily at least partially evacuated.

As discussed above, assembly 10 is designed to maintain a desired vacuum for a considerable period of time. The product, consequently, must have a satisfactory shelf life. Once the fluid collection procedure is completed, the assembly 10 is removed from the fastener 16. Even when the closure assembly 14 is no longer gas impermeable after said removal, liquid impermeability is maintained by the resealable member. The assembly 10 can then be transported to an area where the fluid content of the container can be analyzed. The removal of the closure assembly 14 is a relatively simple procedure that can be accomplished with one hand. The lid 22 is rotated approximately 120-140a according to the preferred embodiment of the invention, and then moved away from the open end of the container. The contents of the container can then be accessed. The closure assembly can be secured again to the open end of the container by first placing the lid on this end and then rotating it. The positioning tabs greatly facilitate the engagement of the container threads 20 and the cover threads 38. Due to the seal between the gas barrier member 44 and the container is relatively weak, this element preferably does not suffer from damage as the lid is rotated and finally separated. The lid, the resealable member and the gas barrier member are consequently separated as a unit and applied again as a unit. The gas barrier member, being intact, forms a fluid-tight seal with the upper edge of the container when the closure assembly is applied again. Although the invention has been described with respect to the preferred embodiment thereof, it will be observed that alternative approaches can be taken with respect to the lid structures, the sealing elements and the container. The threads used to attach the lid and container, for example, could be replaced by other coupling structures such as a bayonet fastening arrangement (not shown). It should be understood that the above-described embodiment of the present invention is simply illustrative of the preferred embodiment thereof. Variations of said embodiment, including those discussed above and others, may be made or used in the manner described and still remain within the scope of the present invention,

Claims (6)

CLAIMS:

1. - A set for collecting blood or other bodily fluids, comprising: an elongate, generally cylindrical container having a closed end and an open end with an edge; a closure assembly removably mounted to the open end of the container, the closure assembly including a lid and a resealable member; the lid having an opening to allow access to the interior of the container, a body portion and at least a deflectable portion defining an outer surface of the lid and connected to the body portion and defining a generally cylindrical envelope around the body portion of the lid; a gas barrier member that covers the open end of the container and that is attached to the edge of the open end of the container and to the closure assembly, the bond between the gas barrier member and the container being weaker than the bond between the container and the container. gas barrier member and the closure assembly so that the gas barrier member is removable with the lid and the resealable member during the removal of the lid from the open end of the container without being damaged as it ruptures. linkage between the gas barrier member and the open end of the container; both, the resealable member and gas barrier member being penetrable by a needle, the resealable member providing an impervious seal to the liquid during removal of the needle.

2. An assembly as described in claim 1, wherein the lid includes an upper wall defining the opening, and the resealable member is bonded to the lower surface of the upper wall of the lid.

3. An assembly as described in claim 2, wherein the gas barrier member is a thin sheet of metal adhered to the resealable member.

4. An assembly as described in claim 3, wherein the resealable member is an elastomeric disc, the thin metal sheet and the elastomeric disc each including edge portions positioned between the edge of the container and the upper wall of the container. lid,

5. An assembly as described in claim 4, including a tube holder comprising a housing and a needle coupled to the housing, the container being positioned at least partially inside the housing, the divertable portion of the lid engaging a wall of the housing and frictionally holding the container in a selected portion.

6. An assembly as described in claim 1, wherein the container includes an external thread, interrupted adjacent the open end, the cover including an internally threaded surface that includes a plurality of thread conductors and a positioning tab adjacent to each of the threads of the cap. 7, - A set for collecting blood or other bodily fluids, comprising: an elongate, generally cylindrical vessel having an open end and a closed end; a closure assembly removably mounted to the open end of the container, the closure assembly including a lid having an upper and a lower part, a resealable member mounted to the lid and an opening in the lid, the resealable member being aligned with the opening; the lid including a deflectable portion on top of the lid and defining an outer surface of the lid. 8. An assembly as described in claim 7, wherein the deflectable portion is comprised of a plurality of deflectable members defining a generally cylindrical external wall of the lid. 9. An assembly as described in claim 8, including a plurality of axially extending slots, defined within the generally cylindrical outer wall and separating the deflectable members and the cap, including a generally cylindrical body portion, the generally cylindrical wall being separated from the body portion by a substantially annular groove. 10. A set as described in claim 7, wherein the deviable portion is an integral part of the lid. 11. An assembly as described in claim 7, including a tube holder comprising a housing and a needle coupled to the housing, the container being at least partially insertable towards the housing so that the needle penetrates the resealable member. and the deformable portion of the cap engages a wall of the housing, thereby maintaining frictionally the container in a selected position within the housing. 12. An assembly as described in claim 7, including a gas barrier member attached to the open end of the container, the gas barrier member also being attached to the resealable member, the resealable member being attached to the lid, the bond between the gas barrier member and the container being weaker than the bond between the gas barrier member and the reseal member. 13. A set for collecting blood or other bodily fluids, comprising: a container having an open end and a closed end, the open end of the container including external threads, interrupted; a closure assembly for the container, the closure assembly including a lid having an opening therein and a resealable member aligned with the opening, the lid including a plurality of internal threads, each of the internal threads including a front portion , the cap further including positioning tabs positioned, respectively, adjacent to the front portions of the internal threads. 14. An assembly as described in claim 13, wherein the cover includes a top wall, the opening extending through the top wall, the resealable member being attached to the top wall, the closure assembly further including a member of gas barrier attached to the resealable member and to the open end of the container. 15. An assembly as described in claim 13, wherein the threads of the closure and container assembly are formed such that the rotation of the closure assembly of less than 180? is sufficient to uncouple the closure assembly from the container even when the closure assembly is engaged in a fully threaded manner to the open end of the container.