DE2061738A1 - Medical sample container - Google Patents

Description

Patent attorneys Dlpl.-Ing. Π. BuETZ sea

DIpI-In ₂ . κ. la:.: .- », ..: · CHT 65-16.4O9P December 15, 1970

Dr.-Ing. Π. DLE TZ Jr.

θ Munich 22, Steinsdorfstr. 10

DAMON CORPORATION, Needham Heights (Mass.) * V.St.A.

Medical sample container

The invention relates to medical sample container devices, in particular to a container for receiving a measured volume of the sample and storage under aseptic conditions.

A large number of devices for the collection and treatment of fluid samples are in the field of Medicine, in particular in the field of clinical diagnostic equipment known. In general, according to the prior art, for receiving a sample, e.g. B. at a Skin puncture uses capillary or syringe devices. The collected sample is then placed in a storage container and the receptacle is disposed of. The storage tank or some other

65- (SN Sah 924) DAII 059-Tp-r (7)

109826/1580

container is then used to hold the sample as needed for to include any diagnostic analysis.

These known practices require a number of liquid containers, and transfer from one to the another container exposes the sample to the risk of spillage or contamination. Also is the identification plate the sample is exposed to loss or mix-up whenever the sample is transferred to a new container will.

In addition, the sample receiving device according to the prior art is often too expensive to have a one-off Discarded use, and thus requires restoration for each reuse. The known Container devices are also flawed in terms of ease of storage, handling and storage Operating.

The invention is therefore based on the object of providing a single container for initially holding a sample a body fluid, for its subsequent storage with or without reagents, and for final absorption or submit the sample for analysis. Such a container should securely fasten the identification plate carry the information about the sample as well as the analysis to be carried out and any other information required wearing. Furthermore, the container to be developed should hold a reagent in a sealed manner, but immediately in its state of use can be brought without the risk of contamination occurs. In addition, it should developing container can be transported without further packaging, and ultimately it should also be under low

109826/1580

Costs can be produced, so that it is also from an economic point of view after a single use is disposable.

Subject of the invention with which this object applies is a container for receiving and storing a liquid sample, which is provided with a receiving tube two ends and a volume sufficient to accommodate the maximum sample volume to be taken up and one with the an ear end chamber connected for the purpose of receiving the liquid from there with a tube volume more than twice Exceeding volume is characterized, wherein the chamber and the tube are liquid-tight to the other end of the tube Form the envelope and the chamber resiliently maintains a normal, collapsed shape for expulsion at least twice the volume of the sample volume of liquid is compressible by means of the tube and resiliently resumes its normal, inconsistent shape when the other end of the tube is used to suck in liquid is open.

Container according to the invention is preferably further by a length of at least part of the length of the Tube arranged and beginning at the outer end of the tube volume measuring scale to display the amount of water going into the tube from the end of the tube volume of liquid sucked in.

The container according to the invention preferably points further in one piece on a plate for receiving the information required in connection with the sample.

In addition to sealing the entire container

109826/1580

_ _k _ 20S1738

in a sterile packaging or other seal of the receiving end of the collecting tube to secure against a Penetration of impurities is the mouth of the tube in the chamber according to a development of the invention sealed so that whatever liquid or gas is filled in the chamber during manufacture so that it cannot leak out or be contaminated. This seal is opened immediately before using the container in such a way that the container system extends over the length of the receiving tube and the chamber remains closed to the environment.

According to a further development of the invention, the container designed so that the receiving tube part can be removed from the rest and the chamber for access to it The sample contained is opened to facilitate dispensing of the sample for diagnostic analyzes.

The invention thus provides a medical sample container for containing a measured fluid sample Volume directly from a patient, for preserving the sample during storage and transport, and for direct delivery of the sample to the analysis device. The sample contained in it! Will never be shed, subject to contamination or disk loss as in previous medical Sampling facilities were possible that require a transfer of the sample from one container to another. aside from that the container according to the invention is inexpensive, so it is economically practical to use it once throw away.

109826/1580

The invention and its advantages are explained in more detail with reference to the exemplary embodiment illustrated in the drawing explained; show in it:

1 shows a perspective view of a container according to the invention which is used to hold a blood sample is already placed at a skin puncture in a patient's finger;

2 and 3 cross-sections of the container according to FIG. 1, but before the detachable seal is opened, along lines 2-2 and 3-3 in FIG. 1; and

Fig. H is a perspective view of the container of Fig. 1 after parts of it have been cut off for the purpose of processing the sample in an analysis device.

1 shows a container 10 according to the invention which is used to receive a blood sample from a skin puncture in a patient's finger. The figure shows that approximately 50 ml of blood have already been taken up by a receiving tube 12 which opens into a chamber 14. The chamber walls 16 are shown somewhat compressed, as the medical professional or other user would normally do to collect a sample by simply squeezing the chamber prior to placing the tube inlet end 12a in the liquid to be drawn. ⁱⁿ Ach release the chamber walls by the user, the spring force jerk of the chamber walls results in the chamber in a unzusammenge-

109826/1580

- ο -

dropped state, causing the sample by the pressure difference is drawn into the receiving tube. The user monitors the expansion of the chamber walls until the has collected the desired volume of sample, then simply removes the container from the liquid source and releases it the chamber walls are completely free, so that they are able to draw the received sample into the chamber 14.

After the desired sample volume has been taken up, the input end of the receiving tube 12 can either be down (" Use one carried by the frame 30, however easily removable therefrom cap 17> by means of a metallic Clamp or heat seal, d. H. after known Types of sealing, to be tightly sealed.

A marker plate 18 for recording the identification of the collected sample, the identification of the patient, its doctor and the designation of the diagnostic tests to be carried out on the sample extends from the container along the other side of the chamber 14 and serve together with the helical receiving tube and chamber as a handle for securely holding the container during the sampling process.

Looking at Figures 1, 2 and 3 in more detail, it can be seen that the illustrated Container 10 has a generally card-like, approximately rectangular shape, of which the receiving tube 12 with his Entrance end 12a protrudes. The tube 12 has a DU-senteil 12b from the input end 12a, a transfer end 12d as opening into the chamber 1U and a helical part 12c zviscxhen the nozzle part and the transfer end on. The illustrated part 12c of the pipe

109826/1580

is designed in a serpentine manner in a single helical position and enables compact accommodation of the for Acceptance of the maximum sample volume that is to be accommodated and processed in the container in question Length.

A scale 20 has arranged over the length of the tube 12 calibrated graduations, e.g. B. in ml, to display the volume of the tube over its length, starting at the entrance end 12a. The scale 20 enables the user to monitor the volume of sample taken directly during the recording.

In addition to the connection point of the pipe with the chamber 14, ie at the pipe end 12d, the pipe is initially closed with a releasable seal 12 (FIGS. 2 and 3). The seal, which is liquid-tight, is formed, for example, by pressing the pipe shut and placing the opposite pipe walls against one another in a sealing manner along a pipe diameter. As FIG. 3 shows, the seal lies in the plane of the card-like container shape. At the point of the seal, pulling lugs Zh and 26 are attached to the walls of the pipe on both sides. With this arrangement, the user brings the container into the use state simply by pulling the lugs apart, thereby pulling the opposing tube walls apart and opening the sealing point.

The chamber \ k is a tubular bag having resiliently compressible opposing side walls 16, "\ 6. The chamber is aligned in the container along the helical portion 12c of the receiving tube, with the chamber bottom adjacent the tube end near the

109826/1580

Nozzle 12b is located. The top of the chamber is next the entrance of the transfer end 12d of the tube into the chamber. The Chamber is with the exception of this liaison with the pipe liquid-tight.

The chamber volume is compared to the maximum sample volume that can be accommodated in the tube of the container, dimensioned accordingly larger. The illustrated chamber holds this volume of sample and a corresponding amount of one Reagent 28 with about 1/2 to 2/3 of the chamber volume.

As noted, the opposing chamber walls 16, 16 can be compressed by the chamber volume to reduce at least twice the volume of the tube 12. When you let go, the walls automatically take their normal position concave shape according to FIG. 2 again, wherein they have a sufficient resilience to suck the liquid sample into the tube 12 and from there into the chamber.

The reagent 28 is selected according to which sample it is and which analyzes are to be carried out with it. For example, it can be an anticoagulant or a protective agent. A known volume of the reagent ¹ is preferably introduced into the chamber Tk prior to the establishment of the seal 20 at the time the container 10 is initially manufactured. Then the doctor, technician or other user of the container has no worries about the identity, volume or quality of the reagent. The container with the desired reagent therein is also ready for use by simply removing the container from its packaging (not shown).

1 0 9 8? ü / 1 S 8 0

The receiving tube 12 consists of a non-wettable, compared to the sample to be received therein and the Reagent 28 inert material which is also suitable for processing in order to provide the detachable seal 22. The material for the chamber 14 has the same inert qualities and also has the desired spring properties with regard to the chamber walls 16, 16, polyethylene and polyvinyl chloride are to be regarded as preferred materials for both the pipe and the chamber, the Density with the correspondingly considerable flexibility

The container 10 shown shows the complete structure of the receiving tube 12 and the chamber 14, the tube seal 22 and the extensions Zk and 26 being provided thereon and everything being mounted in a socket 30. The socket 30 consists of two opposing and mating plates 32 and Jk. Each plate has a channel-shaped recess for receiving the receiving tube and an opening through which the opposing chamber side walls 16, 16 protrude and are accessible for the pumping movement for the purpose of sucking in the sample. The opening approaches Zk and Z6 also extend through the plates 32 and 3k .

In this construction, the tube and the chamber are arranged between the mounting plates, and they are glued or connected in some other way, the receiving tube being inserted between the two plates and the extensions Zk and Z6 and the chamber side walls 16, 16 the plates at the associated openings penetrate. A relatively inert and stiff, protective and self-

1-09826 / 1580

Structural resin is preferred for the socket panels. The one shown. Chamber Ik has a peripheral flange 14a which is inserted between the plates along the periphery of the chamber openings through the plates in order to secure the chamber in the socket 30. The scale 20 can also be carried by one or both plates of the mount 30.

The illustrated Herk plate 18 of the container 10 is formed by the socket plates 32 and Jk along the side of the chamber Ik which is opposite that of the helical tube part 12c. The plate 18 is shown with a matt surface on which features can be written down. However, other shapes of marker plates can also be used. An alternative arrangement consists in providing a memo pocket (not shown) between the opposing mounting plates JZ and 3 ^ for receiving a document with the desired information. Another alternative is to simply apply a leaflet to the outer surface of the notice plate 18 using any of a variety of known fasteners including glue, mechanical clips, buttons, and the like.

Whatever structure is used for the marker plate 18, the information it carries can be machine-readable, i. H. with optical character recognition techniques be readable, magnetically or optically detectable where this is desired.

In Fig. 1, the container 10 consists entirely of three side-by-side sections 10a, 10b and 10c.

109826/1580

The receiving tube 12 is on one outer section 10a, the chamber \ k is in the middle section 10b ₁ and the notice plate 18 is on the other outer section 10c.

One reason for arranging the container 10 in three sections is that it enables the chamber and the marker plate to be separated from the receiving tube Divides border between sections 10a and 10b into two parts. This separation may be desirable in order to reduce the dimensions of the container elements that are present during analysis of the collected sample, which may be of particular advantage where the analysis is performed with automated equipment. The illustration in FIG. K in both solid and dotted lines shows the container elements which would remain intact after the container section 10a, which carries the receiving tube, was so severed by cutting along the line 36.

As shown in Fig. K , a fluid coupling (not shown) can be inserted into the short length of the receiving tube end 12d extending from the chamber to remove the collected sample for analysis.

Furthermore, if the sample is to be openly available for analysis, the container chamber section 10b is separated along the dashed line 38 in FIG. 1 in order to remove the upper part of the chamber including the receiving tube mouth therein and to leave only the analysis container kO, which is shown in FIG h shown with solid lines

109826/1580

is. The marker plate 18 is preferably made shorter in comparison with the other sections of the container 10, as shown in FIG. 1, so that the marker plate 18 is intact when the container is cut off along the line 38 to create the analysis container kO (FIG. K) remain.

The analysis container kO according to FIG. K can be placed in an automatic analysis device with or without the upper section shown in dotted lines, and the sample stored therein can then be analyzed in accordance with the instructions recorded on the memory plate 18.

Although the illustrated container 10 is made as described with a receiving tube and a chamber is, which are enclosed between two plates, the invention can also be implemented with other design features. Perhaps the cheapest construction, at least in the case of mass production, is to use frame plates, which are shaped in such a way that they themselves form the channel for receiving the sample and the chamber for storing it form. Each such plate is then molded around substantially half of the receiving tube or channel and to form half of the chamber.

As an alternative to connecting the walls of the tube 12 in order to create the seal 22, a different one can also be used Use construction. One such alternative is to pinch or clamp the tube with a clip or clamp to squeeze, which is attached from outside the container.

Furthermore, the container system according to the invention is na-

109826/1580

of course not limited to taking a blood sample for a finger puncture; this particular application is only chosen as an exemplary embodiment.

It can be seen that the object is completely achieved according to the above description, and there are certain changes to the above design features, without To leave the scope of the invention can be made, the invention is not limited to the exemplary embodiment limited.

109826/1580

Claims (1)

Claims 1. Container for receiving and storing a liquid sample, characterized by a Receiving tube (12) with two ends (i2a, 12d) and one for Recording of the maximum sample volume to be recorded and one with one end of the tube (i2d) for the purpose of receiving the liquid from there connected chamber (i4) with a tube volume exceeding more than twice Volume, whereby the chamber and the tube have a liquid-tight envelope up to the other end of the tube (I2a) form and the chamber resiliently maintains a normal inconsistent shape, for expelling at least twice Volume of the sample volume of liquid by means of the tube is compressible and resilient the normal reassumes disjointed form when the other Pipe end (i2a) is open to suck in liquid. 2. The container of claim 1, further characterized by a length of at least a portion of the length of the Tube (12) arranged and beginning at the end of the tube (I2a) Volume measuring scale for displaying the volume of liquid sucked into the pipe from the end of the pipe (i2a). 3. The container of claim 1, further characterized by means for forming a releasable liquid seal (22) to block the flow of liquid through the pipe (12) between the pipe end (i2d) and the chamber (i4) and manually operable means (lugs 24, 26) for opening the seal to establish fluid communication between the chamber and said pipe end. 1 09826/1580 k, container according to claim 3 »characterized in that the seal (22) is attached next to the end (I2d) of the tube {12). 5. A container according to claim 1, further characterized by a hand-holdable version (30) as a single Unit for assembling the receiving tube (i2) and the chamber (14), the inlet tube end being like a nozzle (i2b) with a openly accessible end (i2a) protrudes. 6. Container according to claim 5 »further characterized by a marker plate (18) for receiving markers, attached to the socket (30) as part of the one-piece unit. 7 * container according to claim 5 # characterized in that that the socket (30) is designed so that it has at least two laterally connected sections (iOaj 10b), Of which a section (iOb) the chamber ("1 * 0 and the pipe end (i2d) carries to the mouth in the chamber and a second section (10a) carries the remainder of the tube (12). 8. A container according to claim 7 _f, characterized in that the socket (30) comprises a third section (10c) which forms a marker plate (18) next to the section (iOb). 9 ·) Medical sample container for receiving and storing a sample of a body fluid, characterized by a holder (30) that can be held by hand, means for 109826/1, 80 Formation of a tubular channel (12) in the socket with an openly accessible input end (i2a), an output end (I2d) and a memory length (i2b, 12c) in between, a volume display scale (20) on the socket (30) beginning along the channel from the entrance end Partitions for indicating the volume of liquid in the channel from the entrance end, means for forming a bag-like chamber (i4) in the version with the Outlet end (I2d) of the channel to create a fluid connection connected from the inside of the chamber by the channel to the entrance end (i2a) of the channel and opposite has resilient walls (16) which are compressible to reduce the chamber volume and to accept resiliently to a normal incoherent position, and by means of forming a notice plate (18) on the socket to accommodate legible information. 10. A container according to claim 9 »characterized in that the socket (30) is provided with a first and a second section, the first section (iOa), the input end (i2a) and the storage length (i2b, 12c) of the channel (12 ) and carries the associated scale (20), while the second section (iOb, 10c) next to the first section along a first connecting line (36) carries the chamber (i4) and the marker plate (18), the socket sections being designed in this way that a separation of the socket along the first connection line (36) divides the sections and separates the channel at its output end (12d). 11. The container of claim 9, further characterized 109826/1 S80 by means for forming a releasable seal (22) to close off the channel (12) along its outlet end (i2d) and thereby sealing the chamber (ΐΊ) and by manually operable sealing opening means (2k, 26) on the socket (30) for production a fluid communication between the chamber and the channel, the seal and the opening means being arranged so that, when the seal is opened, the channel and the chamber are liquid-tight with the exception of the opening at the channel entrance end (12a). 109826/1580 ii Blank page