Specimen collection assembly with cap

[0001] [Technical field to which the invention belongs] The present invention relates to a collection assembly, which is an assembly of an ultra-small collection container and a cap particularly suitable for collecting a small amount of sample such as blood from a patient, and can access the inside of the container without removing the cap from the assembly. With respect to an assembly that can and can safely and reliably maintain the sample for subsequent testing. [0002] [Conventional technology] Thanks to analytical instruments, it has become possible to make various hematological diagnoses with a very small amount of blood. This blood is collected from a small puncture on the patient's finger or earlobe. Blood is collected in a very small collection container. When a small amount of blood is collected, the container is hermetically covered with a cap. [0003] In order for laboratory technicians to test the blood collected in the container, the cap must be removed from the container to allow access to the blood sample. Alternatively, the entire contents of the container are transferred from this container to a suitable sample holder of the instrument for laboratory analysis. [0004] [Problems to be Solved by the Invention] Therefore, (i) Suitable for equipment for laboratory analysis, therefore the sample does not need to be moved out of the container for analysis, (ii) easily accessible into the container by needles and probes, and leaks from the container. There is a need for ultra-compact collection containers that provide preventable resealable parts, (iii) keep samples safe and secure, and (iv) prevent contamination of samples and users. [0005] [Means to solve the problem] The present invention is a collection assembly comprising a container and a cap. [0006] The container preferably comprises an open end, a closed end, and a cylindrical wall between the two, and the cylindrical wall forms an internal space of the container for accommodating the sample. [0007] Most preferably, the cap body is detachably and hermetically attached to the open end of the container. This cap body has resealable access to the interior space of the container<u style="single">film</u>Supports. this<u style="single">film</u>Is made of a material that can be repeatedly pierced and resealed by a needle or instrument probe. Most preferably this<u style="single">film</u>Is made of a thermoplastic elastomer. This thermoplastic elastomer is composed of isoprene propylene such as MONOPRENE (trademark of QST, Inc.) marketed by QST, Inc. of St. Albans, Vermont. [0008] Preferably this<u style="single">film</u>Has a disk shape with a concave surface on the side far from the internal space of the container,<u style="single">film</u>It facilitates resealing. This thermoplastic elastomer was breached<u style="single">film</u>Allows resealing of the sample to prevent leakage even when the collection assembly is held upside down. [0009] Preferably, the cap body is supported across an upper part, a lower part, a cylindrical side wall having an outer surface and an inner surface extending from the upper part to the lower part, an access passage of the upper part, and the passage.<u style="single">film</u>It has. [0010] The cap body further comprises a downward annular skirt extending from the upper portion into the interior space of the container and defining an annular region together with the cylindrical side wall. The open end of the container is housed in this annular region. This downward skirt has an access passage and crosses this passage as described above.<u style="single">film</u>Is supported. [0011] Preferably this<u style="single">film</u>And the cap body are both injection molded or insert molded. [0012] The advantage of the present invention is that the cap is piercable and self-sealing, which facilitates direct access to the sample for the diagnostic instrument system and allows the micro collection tube to be adapted to the diagnostic instrument. is there. [0013] Another advantage of the present invention is that the self-sealing breakable cap allows the sample in the container to be mixed without transferring the sample to another container, and the sample by the diagnostic instrument through the self-sealing breakable cap. Is to allow direct access to. [0014] Most notably, the invention allows access to the sample through the top of the cap without removing the cap from the container, which minimizes user contact with the sample. [0015] Moreover, the present invention can be used directly in equipment similar to the equipment used for discarded collection assemblies. [0016] The advantages of the bulkheads of the present invention are (i) multiple punctures and resealing, (ii) less than 2 lbs of force for the puncture element to break through, (iii). Concave surface after the piercing element is removed<u style="single">film</u>Is to help be properly sealed. [0017] BEST MODE FOR CARRYING OUT THE INVENTION FIGS. 1 to 3 show the collection assembly 10 of the present invention, and the same reference numerals indicate the same parts throughout these figures. [0018] This collection assembly 10 comprises a container 12 and a cap 14. The cap 14 is detachably attached to the container. [0019] The container 12 is an elongated member having an open upper end 16, a lower end 18 with a closed round bottom 19, and a cylindrical wall 20 extending between them. The cylindrical wall 20 defines an internal space 17 for accommodating a sample such as a blood sample inside the cylindrical wall 20. The cylindrical wall 20 projects beyond the closed round bottom 19 to form an annular extension 22 that allows the container 12 to stand upright on a flat surface. [0020] As shown in FIG. 2, the upper open end 16 of the container 12 is provided with a sloping end rim 24 to facilitate collection of blood samples. Further, the upper end 16 of the tube 12 comprises a cap fitting flange 26 projecting outward in the radial direction to provide a means for detachably and hermetically attaching the cap assembly 14 to the upper end 16 of the container 12. When a sample such as blood is collected in the interior space 17 of the container, the container is hermetically closed by the cap assembly 14. [0021] [0021] Referring to FIG. 4, the cap assembly 14 comprises a cap body 30 and a hermetically sealed partition 32 supported by the cap body 30. The cap body 30 is preferably an integrally molded plastic member in the shape of an inverted cup. The cap comprises a flat top surface 34, an open bottom surface 36 on the opposite side, and a cylindrical side wall 38 extending between them. An annular groove 39 for accommodating the cap fitting flange 26 of the container is formed in the cylindrical side wall 38 adjacent to the opened lower surface 36. The cylindrical side wall 38 comprises a plurality of inwardly facing protrusions 40 that engage the outer surface of the container's cylindrical wall 20 around the upper open end 16 to allow a closed engagement between the cap body 30 and the container 12. I have to. [0022] Further, the cap body 30 comprises a centrally located annular skirt 42 extending downward from a flat top surface 34. The annular skirt 42 and the cylindrical side wall 38 form an annular recess 43 having an open end for accommodating the upper end 16 of the container 12 between them. The annular skirt 42 is centered between an open upper limit 44, an open lower limit 46 on the opposite side that enters the container internal space 17, and access to the container 12 internal space 17 through the cap body 30. It has a passage 45. The lower limit 46 of the annular skirt 42 is an outward-facing annular rib that engages the inner surface of the cylindrical wall 20 adjacent to the upper opening end 16 of the container 12 for better sealing of the cap body 30 and the container 12. It has 48. [0023] Further, the cap body 30 supports the partition wall 32 on the lower limit 46 of the annular skirt 42. The partition wall 32 has a disk shape formed of a thermoplastic elastomer.<u style="single">Membrane</u>Is. As shown in FIG. 4, the partition wall 32 includes a flat portion 50 and an annular protrusion 52 extending upward. The annular protrusion 52 has a diameter that is pushed into and fitted into the lower opening 46 of the annular skirt 42 to maintain a hermetically engaged state. The flat portion 50 of the partition wall 32 faces the internal space of the container 12. The annular protrusion 52 forms a concave surface 53 on the opposite side of the flat portion 50. The partition wall 32 forms a portion 54 having a thickness of about 0.028 inches in the center thereof. This portion 54 allows the cannula or probe used to aspirate the liquid sample from the interior space 17 of the container 12 to be easily pierced into the bulkhead with a force of approximately 2 lbs. [0024] In use, the liquid sample is collected in container 12 and the cap assembly 14 is hermetically secured to the top open end of the container. [0025] As shown in FIG. 5, the sampling cannula or probe 60 is inserted into the container 12 by inserting the cannula 60 through the passage 45 of the cap body 30. Next, the end 62 of the cannula 60 pierces the partition wall 32 at the portion 54. Since the material of the partition wall 32 is a soft thermoplastic elastomer, the partition wall 32 is easily pierced with a low insertion force. Thus, even a relatively large instrument probe with a diameter of about 0.0625 inches can break through this portion 54 of the bulkhead 32 with a force of 2 lbs or less. [0026] Insertion of the cannula 60 is performed until the liquid sample in the internal space of the container 12 is reached, and then a part of the liquid sample is taken. Cannula 60 is then removed by being pulled back through passage 45. When the cannula 60 is pulled out of the bulkhead 32, the thermoplastic elastomer bulkhead naturally self-seals. In addition, the concave surface 50 facing it helps reseal the holes drilled in the partition wall 32 by the cannula 60. The shape of the partition wall forms a concave surface in the pull-out direction of the cannula. The compressive force provided by this shape acts to reseal all holes made in the bulkhead 32 as the cannula 60 is pulled out of the container. In this way, this particular shape of the partition wall 32 and the material forming it allows the partition wall to be resealed even after a large number of perforated areas have been created. Therefore, the self-sealing partition wall for each sample extraction makes it possible to repeatedly collect the liquid sample in the container 12. [0027] The collection assembly of the present invention is made of a thermoplastic material that is shaped so that the collected sample is easy to see. For example, typical materials include polyethylene, polypropylene, polyvinyl chloride and the like. A hydrophilic material or silicone is incorporated into this collection container, or a special surface structure is provided on the inner surface thereof in order to facilitate the flow and mixing of blood introduced into the container. [0028] Colored caps to specify the particular type of fluid collection container containing the material for one or another reason, or to specify the type of test performed on the collected sample. Although providing is within the scope of the present invention, transparent caps can also be provided. It should also be noted that the container is sized to provide the necessary labeling space to identify the sample collected. [0029] [Effect of the invention] As described above, according to the present invention, the following effects can be obtained. That is, (1) Since the cap can be pierced and has self-sealing, it has the effect of facilitating direct access to the sample for the diagnostic equipment system and adapting the ultra-small collection tube to the diagnostic equipment. [0030] (2) The self-sealing breakable cap allows the sample in the container to be mixed without transferring the sample to another container, and direct access to the sample by diagnostic equipment through the self-sealing breakable cap. Becomes possible. [0031] (3) The sample can be accessed through the top of the cap without removing the cap from the container, which minimizes the user's contact with the sample. [0032] (4) This assembly can be used directly on equipment similar to the equipment used for the discarded collection assembly. [0033] (5) The partition wall of the present invention can be pierced and resealed many times, and when the partition wall is formed by a disk-shaped member having a concave surface, the partition wall is properly sealed after the piercing element is removed. Will be done. [Simple explanation of drawings] FIG. 1 is a front view of the collection assembly of the present invention. FIG. 2 is a perspective view of the collection assembly of FIG. 1 showing a container, a cap and a bulkhead. FIG. 3 is a cross-sectional view of the collection assembly of FIG. FIG. 4 is a side sectional view of a portion of the collection assembly of FIG. FIG. 5 shows the collection assembly of FIG. 4 with the probe inserted. [Explanation of symbols] 12 tubes 14 Cap assembly 16 Open end 17 Interior space 20 Cylindrical wall 30 Cap body 32 bulkhead 60 Cannula or probe 42 Ring skirt 43 concave