US3647386A

US3647386A - Sample processing container

Info

Publication number: US3647386A
Application number: US864945A
Authority: US
Inventors: Saul R Gilford
Original assignee: Gilford Instrument Laboratories Inc
Current assignee: Gilford Instrument Laboratories Inc
Priority date: 1969-09-26
Filing date: 1969-09-26
Publication date: 1972-03-07
Anticipated expiration: 1989-03-07

Abstract

A sample processing container, especially for use with samples of some fluid such as blood or blood serum contained in a short length of capillary tubing. The container comprises a flexible plastic bag having its lower end closed and having its upper end sealed to a relatively rigid header. The length of capillary tubing is arranged to be inserted into an elongate cavity or chamber that is formed in the center of the header along its length by way of an entrance at one end of the header. The opposite end of the cavity or chamber communicates with the interior of the bag so that when the length of capillary tubing is disposed in the cavity or chamber, a nozzle may be inserted into the entrance and diluent of a given amount forced through the length of tubing into the bag. This washes the length of tubing clean and provides the proper dilution for a mixture that is to be sampled. The entrance is plugged or, in the alternative, there is a valve in the connection between the header cavity or chamber and the bag that prevents reverse flow out of the bag. The bag can be shaken or kneaded manually or mechanically to assure homogeneity of the sample. A normally blocked entrance to the bag through the top of the header enables sample to be removed by a hollow needle or snorkle for testing as desired. In the alternative, an independent lateral passageway is provided in the header for withdrawing a sample by a dip tube. A second valve is provided at the lower end of the independent passageway at the bottom of the header to prevent reverse flow out of the bag. The header may have a slot, either open or closed for insertion of an identifying label that will be carried with the container. The header may be constructed for mounting on a suitable carrier, so that a plurality may be handled, stored, and viewed together.

Description

United States Patent Gilford 1 Mar. 7, 1972 SAMPLE PROCESSING CONTAINER of some fluid such as blood or blood serum contained in a h short len th of ca illa tubing. The container com rises a [72] inventor Saul Gluord Oberlin Ohm flexible pistic bag hav iiig its lower end closed and hd ving its [73] A i Gilf -d lmt ument L bo atorie [n,, upper end sealed to a relatively rigid header. The length of Oberlin, Ohio capillary tubing is arranged to be inserted into an elongate cavity or chamber that is formed in the center of the header [22] Fled: Sept 1969 along its length by way of an entrance at one end of the [21] AppL 864,945 header. The opposite end of the cavity or chamber communicates with the interior of the bag so that when the length of Related U.S. Application Data capillary tubing is disposed in the cavity or chamber, a nozzle may be inserted into the entrance and diluent of a given [63] commuanonm'part of amount forced through the length of tubing into the bag. This 1969' abandoned washes the length of tubing clean and provides the proper dilution for a mixture that is to be sampled. The entrance is [52] U.S. Cl. ..23/230 R, 23/253 R, 23/259, plugged or, in the alternative, there is a valve in the connec 206/47 Av 229/56 229/625 tion between the header cavity or chamber and the bag that [51] Int. Cl. ..G0ln 1/10, G01 n 21/02, 365d 32/00 prevents reverse flow out f the bag The bag can be shaken or [58] Field of Search ..23/230, 253, 259, 292; kneaded manually or mechanically to assure homogeneity f 206/47 A, 47 R; 229/56, 62.5; 128/2, 272, DIG. 24 the Sample 56] References Cited A normally blocked entrance to the bag through the top of the header enables sample to be removed by a hollow needle or UNITED STATES PATENTS snorkle for testing as desired.

3,476,515 11/1969 Johnson, et a1. ..23/230 In the alternative, n independent lateral p g y is p 3,266,298 8/1966 Whitehead er 23/253 X vided in the header for withdrawing a sample by a dip tube. A 3,526,125 9 970 (mford, r a] 73 423 A second valve is provided at the lower end of the independent 3,297,152 1/ 1967 Corella, et al.. .....229/62 5 X passageway at the bottom of the header to prevent reverse 3,189,252 6/1965 Miller ..l28/DIG. 24 flew out of the Primary Examiner-Morris O. Wolk Assistant Examiner-Elliott A. Katz Att0meySilverman & Cass The header may have a slot, either open or closed for insertion of an identifying label that will be carried with the container.

The header may be constructed for mounting on a suitable carrier, so that a plurality may be handled, stored, and viewed [5 7] ABSTRACT together.

A sample processing container, especially for use with samples 29 Claims, 18 Drawing Figures g 0 46 62 4 g 36 2 3 i i PATENTEUMAR 7|972 3,647,386

sum u UP a a -MK? nkggtwz SAMPLE PROCESSING CONTAINER REFERENCE TO RELATED APPLICATIONS This is a continuation-in-part application to application Ser. No. 793,504, filed Jan. 23, 1969, now abandoned.

While it is believed that the disclosures of the several applications which will be identified hereinafter are not needed for a complete understanding of the invention, nevertheless, it will be convenient to refer to them so that some of the various aspects of the invention and the advantages thereof will be appreciated.

The basic concept of using lengths of capillary tubing for entraining precise volumes of concentrated fluid is disclosed in an application Ser. No. 472,294, filed July 15, 1965, now U.S. Pat. No. 3,475,127. As taught in said application, by using accurately formed capillary tubing, one may measure out a precise volume of sample by cutting a measured length of tubing. Thereafter, the length can be dropped into a quantity of diluent and agitated or diluent washed through the length into a container so that the resulting sample is a desired dilution.

Cuvettes for holding and handling lengths of tubing to enable dilution of the entrained liquid are disclosed in application Ser. No. 691,783, filed Dec. 19, 1967 and entitled Biological Fluid Sample Processing Apparatus, now U.S. Pat. No. 3,545,932.

Apparatus for drawing samples of blood at a patients bedside directly into the lengths of capillary tubing preparatory for centrifuging and later cutting the long lengths into smaller sections is disclosed in application Ser. No. 781,386, filed Dec. 5, 1968 and entitled Apparatus for Sampling Blood or the Like Fluid. A sample identifying system and apparatus suitable for use with the containers of the invention are disclosed and claimed in application Ser. No. 691,751, filed Dec. 19, 1967 and entitled Sample Identifying System and Apparatus for Use in Connection Therewith, now US. Pat. No. 3,526,125.

All of the above-identified applications and patent are owned by the assignee of this application.

FIELD OF THE INVENTION AND DISCUSSION OF PRIOR ART The field of this invention is broadly testing of liquids, and the specific direction toward which the invention is pointed is the provision of novel containers for processing and holding liquid samples.

While the invention has relatively wide scope and broad implications insofar as its field of use is concerned, it was developed principally for use in the medical and biological testing and research field, where biological fluids are gathered, diluted, and/or processed and tested. To an even more specific extent, the invention has important advantages where it is used in handling blood and blood serum. The description of the preferred embodiments and the discussion will be specifically directed to the handling of blood and the like biological fluids, but no limitations on the coverage of the invention are intended thereby.

As previously mentioned, the invention resides primarily in the construction of a container for a liquid sample that has been introduced into the container by flushing a diluent through a short length of capillary tubing. This technique per se, not considering the container which is described and claimed herein, and which comprises simply entraining a quantity of concentrate in a capillary tube and using a precise length to make a dilution, is a new one. It departs from classical methods of gathering and diluting biological fluids in some important respects that are detailed in the U.S. Pat. No. 3,475,127 above-referred to. The primary difference lies in the use of a long length of capillary tubing to achieve precise volumetric measurements of liquids entrained therein.

Capillary tubing is used to obtain small quantities of capillary blood at the bedside of patients in most hospitals. These small lengths of tubing are not used for any measurements because they are handled by the technician without regard to contamination of the ends; no known techniques and apparatus are available for handling, measuring and cutting the same other than described to some extent in the patent and applications above referred to; and because other types of fluid-gathering techniques and apparatus are normally used for the majority of cases. The known capillary tubing uses include a technique in which the samples are gathered by simple capillary action at bedside following which each is plugged by wax or clay at one end, spun down in a centrifuge to pack the cells at one end, scored and broken through above the packed cells, and the resulting section with serum entrained is blown into a small container so that it may be diluted suitably for test runs. The relative lengths of the packed cell volume and the serum volume may be measured before breaking the length of tubing in order to ascertain hematocrit index, but in view of the very short lengths of such tubing used, the accuracy of this kind of comparative measurement is not too reliable.

It will be appreciated that the entire technique described above requires a piece by piece manual handling, and that the discharged serum is required to be measured after it leaves the length of capillary tubing.

Another known type of technique involves providing a short length of capillary tubing having a precise dimension and representing a known volume. The technician uses this short length to gather the samples at bedside, and then works with the resulting filled length. This technique does not involve any precision cutting but does have the disadvantages of the usual techniques in that the end of the length is usually wiped by the technician to eliminate excess and/or may have some of the fluid wetted on the exterior. In either case, there can be serious contamination or variations in total entrained volume. In this latter technique the length of capillary tubing is emptied and rinsed into a predetermined volume of reagent or diluent that is properly related to the volume of the length of tubing.

According to the disclosures of the applications aboveidentified, the technician uses a container which carries a plurality of lengths of capillary tubing within a vacuum and pierces one end of a double-ended canulla into the patients vein while inserting the opposite end into container. This fills all of the lengths of tubing with venous blood simultaneously and retains them in a sterile container. The lengths are longer than readily can be handled without breakage in ordinary usage by technicians. While still in the container, the lengths are all centrifuged and thereafter are introduced into a suitable measuring and cutting apparatus from which they can be dropped directly into containers.

The cut lengths have the entrained serum or could as easily have other biological fluids, but have not thus far been contaminated. They were accurately broken from long lengths along with their respective columns of entrained fluid and have not been wiped or touched during the processes.

The invention herein provides suitable containers for receiving these lengths of capillary tubing with their entrained liquids directly from the cutting machine or other apparatus. One would bring the container under the apparatus and have the length fall into the container as it is cut or broken from a larger length. Thereafter, one would introduce a nozzle into the container and force diluent or reagent into the container. According to the invention, the length of capillary tubing is in the path of the incoming fluid so that the contents of the length of tubing will be flushed into the container along with the diluent.

While providing an excellent form of container suitable for most purposes when used with these short lengths of capillary tubing, the structures of application Ser. No. 691,783 referred to above have substantially been improved upon by the invention herein. Likewise, the invention herein provides advantages and benefits not contemplated either by the invention of the earlier applications or by known prior containers. Prior containers were open, giving rise to evaporation, dust deposit and spillage during handling. They occupied a substantial space and posed problems of thorough mixing. Where heating was required the prior containers were incapable of being used in simplified heating techniques. Handling, storing, transporting and identifying were important problems not solved as readily by prior containers as with the invention herein.

SUMMARY OF THE INVENTION According to the invention, the container comprising an embodiment thereof is formed of plastic materials such as polyethylene or other synthetic resins, capable of being formed by extrusion, molding and other techniques. These containers are highly economical and disposable so that they can be used once and will thus be sterile for the particular testing being done.

A flexible bag is provided which is sealingly secured to the lower side of a relatively rigid header. The bag is closed on its bottom edge and along its two side edges, and its mouth is engaged to the lower edge of the header. A single entrance into the bag is provided by a passageway from one end of the header into the chamber constituting the interior of the bag, which is otherwise fully enclosed. In the header along the length thereof there is provided a cavity or chamber which opens to one end of the header and thus provides an entrance to the cavity or chamber, the opposite end being partially closed off. At said opposite end, the cavity or chamber connects with the aforementioned passageway, and the said passageway is preferably arranged vertically. Since the length of capillary tubing is engaged into the cavity and will bottom at the end therein, some means are provided so that when this occurs the hollow central bore of the length of tubing will still be unobstructed. When the diluting liquid or reagent is forced into the cavity from the same open end that the capillary tubing was introduced, a goodly portion thereof must flush through the hollow bore of the length of capillary tubing so that the entrained liquid will be washed out of the length of tubing, the chamber and into the bag by way of the passageway. Several ways of standing the end of the length of tubing away from the bottom of the cavity or chamber are suggested in the specification.

In, another embodiment of the invention, a lateral passageway is provided through the header which is independent of the lateral passageway connecting the second end of the chamber or cavity with the interior of the bag.

Although the bag is expected to be perforable or capable of being cut to draw a sample of the diluted liquid therefrom for testing, it can be appreciated that this is somewhat destructive of the container. The sample in the bag may have to be caught in another receptacle if it is to be used in multiple tests, or used forjust the one test and discarded. The contents will flow out or leak once the bag has been pierced or cut, unless an integral nipple is formed on the bag surface for constriction around the piercing member so that no fluid is lost in the transfer. While this latter concept is included in the scope of the invention, it unnecessarily complicates the structure.

The preferred embodiments have a second passageway opening to the top of the header, normally blocked, but capa- -ble of being pierced or opened by a dip tube. Thus, the second passageway will be aligned axially with the first passageway and will not come into use while the sample is being introduced into the bag by way of the chamber and the first passageway. Afterthe dilution has been made and is fully contained within the bag, there may be some processing through which the container will be passed, such as heating, agitating and/or kneading to mix the sample thoroughly. At this point, it isdesired to withdraw one or more samples from the bag to perform the desired tests. The dip tube referred to may be a hypodermic needle, a so-called plastic snorkle tube or a combination of both. It is introduced into the first passageway and pushes the obstructing member aside, or pierces it. This embodiment has an elastomeric plug which has its center easily pierced by a hollow needle. The dip tube is pushed further through the aligned first passageway and past a check valve which is disposed at the outlet end of the first passageway to prevent escape of liquid from the bag while it is being mixed or heated.

Another embodiment has an independent passageway extending laterally through the header from the top to the bottom thereof. It has a check valve at the bottom of the header at the lower end of the passageway. No plug is required in this passageway, and the dip tube does not require a sharp end (for piercing the plug).

When the dip tube is under the surface of the liquid sample, a quantity may be withdrawn for colorimetric, chemical or mechanical testing. Other samples may be withdrawn from the bag subsequently, since the dip tube does not destroy the container or affect either the elastomeric plug or the check valve.

The structure of the invention advantageously may include some means for mounting an identification card on the header so that the sample in the container is fully identified throughout the period of time that it is being produced, handled and used. A special arrangement of identification card combined with the container is described and claimed. Means are provided for storing and carrying a plurality of containers with facility. A novel track type of carrier is described and claimed in combination with the container.

Many advantages and features will become apparent from the description, and others will specifically be pointed out.

BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is an exploded perspective view of a sample processing container constructed in accordance with the invention, and showing therewith an identification card and a length of capillary tubing both disposed for association with the container.

FIG. 2 is a side elevational view of the container of FIG. 1 taken from the left side thereof as viewed in FIG. I and showing the identification card attached thereto.

FIG. 3 is a median sectional view taken generally along the line 33 of FIG. 1 and in the direction indicated, showing the length of capillary tubing in place on the interior of the header, the identification card not being shown in this view.

FIG. 4 is a fragmentary sectional view of that portion of the container generally located at the upper right-hand corner of FIG. 3, but in this case a modified form is illustrated.

FIG. 5 is an exploded perspective view of a simplified form of the container of the invention having an identification card or member attached to the header, and showing a length of capillary tubing about to be engaged inside of the header.

FIG. 6 is a median sectional view through the container of FIG. 5 taken generally along the line 6-6 of said FIG. 5 and in the indicated direction, but in this view the length of capillary tubing has been disposed on the interior of the header, a fragment of a nozzle is shown forcing diluent through the length of tubing past the check valve and into the bag. The view also illustrates an alternate form of liquid blocking means to prevent escape of liquid from the container when handled.

FIG. 7 is a sectional view taken through the container of FIG. .6 along the line 77 of FIG. 6 and in the indicated direction.

FIG. 8 is a fragmentary perspective view of a container showing the construction of means of mounting and carrying the container.

FIG. 9 is a view similar to that of FIG. 8 but showing a modified form of mounting and carrying means.

FIG. 10 is a top plan view of a fragment of a support structure for carrying a plurality of containers whose construction is generally the same as that of FIGS. 1 through 4, and showing one such container mounted thereon.

FIG. 11 is a sectional view taken generally along the line 1l1 l of FIG. 10 and in the indicated direction.

FIG. 14 is a fragmentary perspective exploded view of the container of FIGS. 12 and 13, showing the type of identification card which is adapted to be combined therewith.

FIG. 15 is a top plan view of the apparatus of FIG. showing means for effecting transfer of a container from the support structure to another without handling the container manually.

FIG. 16 is afragmentary sectional view taken generally along the line l6-l6 of FIG. and in the indicated direction.

FIG. 17 is a diagrammatic view showing a rack of containers disposed in a high frequency oven for heating the same.

FIG. 18 is a median sectional view similar to that of FIG. 3, but taken on a container having a header which is provided with an independent lateral passageway.

DESCRIPTION OF THE PREFERRED EMBODIMENTS In FIGS. 1, 2 and 3 there is illustrated a sample container which is constructed in accordance with the invention and having several advantageous features which enhance the efficacy of the use of a structure of this kind.

The container of FIGS. 1, 2 and 3 is designated generally by the reference character 20. The body of the container is in the form of a flexible bag 22 about an inch square, conveniently formed of an extruded length of plastic tubing. The

side walls

24 and 26 are thus devoid of seams. The bottom end 28 is closed by a transverse seal 30 which may be achieved thermally, electronically or by means of a suitable cement. The bag as thus far described would have an open upper mouth designated generally 32.

The material from which the bag 22 is made is preferably rather thin and transparent. For example, a wall thickness of 0.0015 to 0.0025 inch is practical because it provides the necessary strength, is easily sealed by heat, and can readily be kneaded. Extruded polyethylene tubing will meet practically all of the requirements of the bag. Other flexible plastic materials could be used. Obviously these materials should be chemically inert with respect to the liquid solvents used and the samples to be carried by the bag 22. As will be seen hereinafter this form of plastic or synthetic resin has another advantage in connection with heating the sample.

An elongate header 34 is mounted in the mouth 32 of the bag 22, closing the same off fully except for a passageway which shortly will be described, thereby providing an interior chamber or space 36 for reception of a quantity of liquid sample, such as for example that which is designated 38 in FIG. 3. The header 34 is formed as an elongate upper portion 40 of generally rectangular cross section having a central lower boss or projection 42 that is relatively smaller in plan than the dimensions of the upper portion 40. This gives rise to a peripheral overhanging shoulder 44 surrounding the boss 42, the shoulder 44 having advantageous uses which will be described. It will be seen that the boss or projection 42 is tightly engaged within the mouth 32 of the bag 22 and sealed at that point Since the header 34 preferably is made of the same synthetic resin as the bag, such as for example polyethylene, it is a simple matter to provide such weld or seal at 46, as for example by heat or an adhesive, to achieve the tight connection. If the bag mouth 32 has a circumference slightly smaller than the periphery of the boss 42 so that the mouth must be stretched to engage the boss, the attachment will be frictionally tight in any event.

Through the center of the upper portion 40 of the header 34 there is provided an elongate cavity or chamber 48 having a flared entrance at 50. A length of capillary tubing is designated 52, and this length of tubing is adapted to be inserted into the cavity or chamber 48 by way of the entrance S0. The flared entrance serves as a pilot for introduction of one or more lengths of capillary tubing and to enable insertion ofa source ofdiluent.

While the insertion along the line 54 as viewed in FIG. 1 can be accomplished by any mechanical means, it is practical to turn the bag on its side 24 thereby elevating the entrance 50 so that the cavity 48 is arranged vertically. A suitable apparatus which cuts and separates the small section 52 from a larger length of capillary tubing can then drop the small length of tubing into the cavity 48 by gravity. It is assumed that the length of tubing 52 will have a concentrate of some fluid, such as for example whole blood, entrained therein and it is intended that the liquid sample 38 will consist of a dilution of this concentrated fluid.

As shown in FIG. 3, the right-hand end of the cavity 48 is provided with a narrow cross section connecting conduit 56 which leads to a vertical first passageway 58, the bottom end of which opens to the chamber 36, being blocked at this lower point by means of blocking means comprising a flapper valve 60. The flapper valve 60 may be a simple plastic member welded to the lower surface 62 of the boss 42 at the point 64. The flapper valve 60 functions as a check valve and it could be located anywhere in the conduit 48, conduit 56 or passageway 58, since its purpose is to contain the liquid 38 when it is being agitated, kneaded or otherwise shaken.

The presence of the narrow cross section conduit 56 provides antiblocking means comprising a blocking structure 66 at the bottom end, that is, the right-hand end as viewed in FIG. 3, of the conduit or chamber 48. If the length of capillary tubing 52 is bottomed and it is intended that diluent or other reagent be flushed through the hollow bore of the length of tubing, it is essential that there be free flow into the passageway 58. If the structure 66 is not used some other antiblocking means for providing unobstructed flow must be provided.

There is a second vertical passageway 68 that is coaxial and hence aligned with the first passageway 58, the second passageway 68 opening to a flared pilot entrance 70 that is formed in a nipple or projection 72 integral with the header 34 and protruding from the upper face 74 thereof. This projection is called a hollow riser hereafter. The passageway 68 is normally blocked by means of a small plug 76 of rubber or other elastomeric material compatible with the liquids being used. The purpose of the plug is to enable the dilution to be made before mixing the sample and drawing the test amount.

As thus far described, the sample container 20 is useful to achieve the principal ends of the invention. After a length of capillary tubing 52 has been inserted into the chamber 48, and with the plug 76 in place, a nozzle, such as for example that which is illustrated at 78 in FIG. 6, is inserted into the entrance 50 in a fluidtight mating engagement. A predetermined amount of diluent or reagent is forced into the cavity or chamber 48, passes through the length of capillary tubing 52 through the small conduit 56 into the passageway 58, forcing the flapper valve 60 open, and then flows down into the chamber 36.

It is essential that there be sufficient blockage of the conduit 48 by the length of capillary tubing 52 so that a portion of the diluting liquid will flush through the hollow bore of the length of tubing 52. In view of the quantity of diluent used, and depending upon the pressure with which it is forced into the chamber 48, the diameter, and hence the transverse area of a cross section of the conduit 48 could be several times greater than the diameter or cross-sectional area of the length of capillary tubing 52. There normally will be a sufficient flow such that even though a major portion of the diluting liquid flows around the length of tubing 52 that portion which actually traverses the hollow bore will flush the same. This enables a header 34 to be constructed with a conduit or chamber 48 whose cross-sectional area is large enough to receive several lengths of tubing 52 arranged parallel with one another. The cross-sectional configuration of the cavity or chamber 48 need not be cylindrical but could be cruciform, triangular or even polyfoliate to provide lobes within which lengths of capillary tubing may be accommodated. Obviously, the cross section of the length or lengths of tubing must pro vide sufficient interception of the transverse area of the chamber 48 to capture enough diluent to result in flushing.

During the introduction of diluent or reagent into the container 20, the plug 76 is in place. After having introduced the diluent so that the liquid sample 38 is in the bottom of the bag as shown in FIG. 3, it is a simple matter to agitate the same, knead it or shake it without danger. The check valve 60 blocks any possible loss of liquid and even if located in the cavity 48, the plug 76 prevents emergence of any liquid by way of the second passageway 68. In this form, the container and its sample may be stored, transported or even heated without difficulty.

In FIG. 17 for example, there is illustrated in diagrammatic form, an oven 80 having a radiation energy distributing horn 82 driven by a generator of microwave high frequency energy,

such as for example a magnetron 84 which is energized by suitable power supply 86. A rack 88 carrying a plurality of sample containers 20 is shown mounted in the oven. Since the type of high frequency energy which is obtained from a microwave generator does not afi'ect the type of synthetic resin from which it is preferred that the containers 20 be made, this forms a highly advantageous structure and method for heating the sample 38 quickly.

After the sample 38 has thoroughly been mixed, a quantity is to be withdrawn for testing purposes. The invention contemplates that the bag 22 may be pierced or cut to release the sample in which case the passageway 68 is not needed. A structure of this kind is illustrated in FIGS. 5, 6 and 7. It is preferred, however, that a sample be withdrawn by way of the

passageways

68 and 58 in a manner which is not destructive of the container 20 or wasteful with respect to the sample 38. In this way, several samples may be withdrawn if desired.

The pilot entrance 70 is adapted to receive a dip tube 90 therein, this dip tube 90 being either a hollow hypodermic needlelike member with a sharp point 92, or it may be in the form of a snorkle passing through the center of the hollow member 90. Thus, since a sharp point 92 may damage or hang up on the flapper of the check valve 60, it will pierce the plug 76 and its entry stopped at this point. Then a center hollow tube may be telescopically pushed down into the body of sample 38 to withdraw the same for testing. The designation dip tube is used hereinafter to include any form of hollow member which is introduced to pass into the chamber 36 of the bag 22 to withdraw some of the liquid 38, whether a single member or a plurality of telescoping members. Instead of being imperforate, the plug 76 may have a form of normally tightly closed slit therein which can be invaginated by a blunt ended snorkle without the likelihood of causing damage to the check valve 60. The lips of the slit would have to be fluid tight normally to prevent leakage when the sample is being introduced into the bag 22.

In FIG. 4 a modified form of container designated 20 is illustrated. The only difi'erence between the

containers

20 and 20 is that in the container 20' there is no riser 72 protruding from the upper surface 74 of the header 34. Instead, there is a relatively large socket 94 formed in the upper portion 40 of the header below the surface thereof and in said socket there is inserted an elastomeric cap 96 whose central portion 98 is in the form of a pierceable diaphragm giving access to the first passageway 58 In all other respects, the container 20' is substantially the same at the container 20.

FIG. 18 illustrates another embodiment of container designated 420. This container differs from container 20 in that there is provided in the header 434-a lateral passageway 468 extending from a flared pilot entrance 470 in the upper part of the header to the lower end of the header. The passageway 468 is independent from and is not connected with the chamber or cavity 448 nor with the passageway 458 which connects chamber 448 with the interior of the bag 420.

A first flapper valve 460, similar to valve 60 is welded to the lower surface 462 of the header 434 at the point 464. At the same point, a second flapper valve 461 is welded to the surface 462. The

valves

460 and 461 serve as check valves for

passages

458 and 468 respectively. The

valves

460 and 461 may be an integral plastic member, the center portion of which is welded at point 464 to surface 462. The header 434 has certain advantages over the header 34 of FIGS. 1 to 3.

The passageway 468 does not require a plug 76 as in passageway 68 of header 34, because passageway'468 does not communicate with chamber 448. A dip tube 490 used for withdrawing a sample from the bag 422 does not have to have a sharp tip 92 as is necessary for piercing plug 76 in header 34.

For identification purposes, it is preferred that a system used with the container that isdisclosed in above-identified application Ser. No. 691,751. This system utilizes a type of identification card that has pertinent identifying information imprinted thereon at 102 such as patient name, doctor name, test identification and so forth and may have an area 104 within which the test results will be imprinted. It is contemplated that such test results will be imprinted at substantially the same time or quite close in time to testing the sample withdrawn from the container 20. The area 104 may be on an adhesive label.

As shown, the header 34 has a slot 106 cut or otherwise formed along one edge substantially parallel therewith, and the card 100 is engaged in this slot. If the slot 106 is closed at its center instead of being open as shown at 108, the identification card 100 may be inserted from an end thereof an drawn through the slot to any desired location, as for example, would be controlled by protuberances (which are not shown) on the edges of the card 100. The slot is laterally spaced from the bag as best seen in FIG. 11 so as not to interfere with the proper use of the container 20.

The preferred structure is as shown in FIGS. 1 and 2. As stated the slot 106 has its center portion open to the outer edge of the header 34 thereby providing closed ends 110 for the slot 106. The card 100 has conforming notches which are relatively rectangular as shown at 112. To insert the card 100, it is buckled in its center and slipped into place and then permitted to recover its flat condition. Preferably the width of the card 100 is somewhat greater than the distance between the ends of the slot 106 so that when released from buckled condition there will be portions overlaying the top surface 74 and underlying the shoulder 44 of the upper part 40 of the header 34. This is best shown in FIG. 2.

The container shown in FIGS. 5, 6 and 7 is a highly simplified version of the container 20 previously described. The bag 122 is not substantially different although the header 134 departs to some extent from the construction of the header 34. There is no riser 72 and as a matter of fact there is no provision for sampling by means of a dip tube.'lnstead the central cavity or chamber 148 intersects a first passageway 158 and is prevented from bottoming by a structure 166. The upper surface 174 is unobstructed. The liquid is introduced through the nozzle 78 as previously mentioned, passes through the length of capillary tubing 52, passes into the first passageway 158 past the flapper valve 160 and enters the chamber 136 to fill or partially fill the bag 122 and provide the diluted sample 138. Identification card 200 is attached to suitable buttons 206 which are integral with the header 134 and pass through perforations 210 which may be provided in the identification card 200. In all other respects, the container 120 is similar to the container 20.

It will be noted that instead of the flapper valve 160, a small rubber plug 160' may be inserted into the entrance to block liquid from flowing out of the container during the time it is being mixed, transported or kneaded.

In addition to the advantages which have been described in connection with the

container

20 and 120, there are others which relate to its characteristic of being collapsible. When first provided by the manufacturer, the bag 122 may be perfectly flat without any air in it. Accordingly, when liquid is introduced into the bag it will expand without the need for providing a relief for air escape. Additionally, the pressure applied by means of the nozzle 78 can be quite high since the bag is enclosed, and yet there will be no splashing or spraying as in the case of open containers. Likewise, with the bag fully sealed, as for example by the flapper valve or the plug 160, any heating of the containers will result merely in an expansion of the bag 122 without any loss of fluid and without any undue pressures being generated.

The

containers

20 and 120 both illustrate a type of

header

34 and 134, respectively, provided with shoulders. The shoulders are 44 in the first form of the invention and 144 in the second form of the invention. While it is not essential to use such overhanging shoulders, they are of convenience in mounting, storing or transferring the containers as will be described in connection with FIGS. 10, 11, 15, and 16. Other ways of carrying or storing containers do not depend upon the shoulders. Thus the containers 220 and 320 of FIGS. 8 and 9 need not have any shoulders but instead the respective headers 234 and 334 are provided with supporting means for carrying or hanging the containers on a suitable rack or brackets or other carrying device. In FIG. 8 the header has a dovetail notch 208 cooperating with a tongue or rod 245 along which the container 220 may slide. The container 320 of FIG. 9 has a pair of loops 308 integral with the header 334 to be received upon a pair of rods 345 for the same purpose as previously described.

FIGS. 10 and 11 illustrate the manner in which a carrying device 88 having tracks 145 secured thereto may be used for carrying or storing the type of containers such as 20 and 120 that have shoulders thereon. Such shoulders are designated 44 and 144 in the several views. The tracks 145 each comprise a pair of members 147 which while here shown in the form of facing channel-shaped structural members need only have the lower flange formations 149. These flange formations are separated by a distance somewhat less than the width of the upper portions 40 and 140 of the

respective headers

34 and 134 so that the

container

20 or 120 will straddle the flange formations 149 with the

bag

22 or 122 depending in between. The particular container illustrated in FIGS. 10 and 11 is the container 20 characterized by the presence of the riser 72, but any structure with shoulders would be suitable for use with the tracks 145. It will be noted that identification card 100 is clear of the flanged formation 149.

A structure eliminating the

shoulders

44 or 144 but having outwardly extending flanges on the header itself could cooperate with tracks having grooves instead of the flange formations 149.

In place of the notches 1112 which are shown in the structure of FIGS. 1 and 2, the identification card 100 may be constructed as shown at 100 in FIG. 14. [n this case, the notches 112' are angular, being generally triangular in this case. The container 20' is identical in all respects to the container 20 except that the slot end 110' has conforming configurations being generally pointed so that they fit into the angular notches 112'. The identification card 110' will thus be accurately seated in the slot 106.

The advantage of the riser or nipple 72 will become obvious from an examination of the structures in FIGS. and 16. In these figures the container illustrated is identical to that of FIGS. 1, 2 and 3 with the exception that the identification card 100 is not included in the illustration. In this case the container shown mounted on the track 1450f the carrying device 88 is to be transferred to a similar track 145' carried, for example, on another carrying device, bracket or on a moving belt or the like. The upwardly protruding nipple or hollow riser 72 is engaged by a forked transfer mechanism 151 and easily moved as desired. Other mechanisms for transferring the container 20 may be used, either with or without the riser 72 being incorporated into the header 34 of the container 20.

It will be obvious that considerable variation is capable of being made in the several structures without departing from the spirit or scope of the invention as defined in the appended claims.

What is desired to be secured and claimed by Letters Patent of the United States is:

1. A sample processing and holding container, comprising A. an imperforate flexible bag formed of liquid impervious material,

B. an elongate hollow header having an elongate cavity formed therein and of a dimension selected fully to retain at least one length of capillary tubing, and said header having the bag sealed thereto,

C. means at the entrance end of said cavity for enabling the introduction into and full deposition of at least one length of capillary tubing entirely within said cavity and spaced from said entrance,

D. antiblocking means at the outlet end of said cavity to maintain free passage from the tube bore to the bag when the tube is bottomed at said outlet end,

E. a passageway in said header, connecting said cavity at said outlet end to the interior of said bag to lead liquid from said cavity into said bag for retention therein, and

F. blocking means for preventing inadvertent loss of liquid from said bag by way of said passageway and cavity.

2. The container as claimed in claim 1 in which the blocking means comprises a one-way check valve for blocking said passageway and cavity flow out of the bag while permitting flow into the bag.

3. The container as claimed in claim 1 in which the blocking means comprises a removable plug inserted into the entrance end of said cavity.

4. The container as claimed in claim I and an identification card, means carried by said header for mounting said identification card removably thereon so that said card will accompany the container during the processing of the sample introduced therein, said header having a vertically arranged slot therein spaced laterally from said bag and said identification card is capable of being inserted and held in said slot.

5, The container as claimed in claim 4 in which said slot is arranged parallel to an elongate edge of said header and has the center portion thereof open to said edge so that said identification card may be buckled to pass through said open portion and released to engage the closed ends of the slot.

6. The container as claimed in claim 5 and said identification card being of sufficient flexibility to permit buckling and recovery thereof and having lateral notches engaged in the ends of the slot 7. The container as claimed in claim 6 in which the notches in the card are generally angular and the slot ends have configurations which substantially conform to the shapes of said notches.

8. The container as claimed in claim 1 and means in the header to enable withdrawal of a quantity of liquid from the bag, said means comprising a normally obstructed conduit in said header, alignedwith said passageway, for permitting the introduction of a dip tube into said bag for said withdrawal of a quantity of liquid from said bag.

9. The container as claimed in claim 8 in which said header has a hollow riser protruding from the upper side thereof, said normally obstructed conduit including the hollow bore of said riser, and the upper end of said hollow bore having a piloting entrance capable of guiding entry of said dip tube therein.

10. The container as claimed in claim 8 in which said normally obstructed conduit has a sealing plug therein which is capable of being pierced by said dip tube.

11. The container of claim 10 in which said sealing plug is of elastomeric material and has a diaphragm at the location where it will be pierced.

12. The container as claimed in claim 11 in which said header has an upper surface all of which lies substantially in the same plane and said normally obstructed conduit has an opening which opens to said upper surface with said sealing plug comprising a stopper engaging in said opening and having a portion telescoped within said conduit, said diaphragm being in said telescoped portion.

13. The container as claimed in claim I, and means in the header for selectively withdrawing liquid from said bag comprising a second passageway opening at its upper end to the upper surface of the header, extending from said upper surface of said header to the lower surface of said header, said second passageway having its lower end opening to said lower surface, and second blocking means for preventing inadvertent loss of liquid from said bag by way of said additional passageway.

14. The container as claimed in claim 13, in which both blocking means comprise first and second check valves.

15. The container as claimed in claim 14 in which the second check valve is mounted at the lower surface of the header and constructed normally to block the lower end of said additional passageway.

16 The container as claimed in claim 15, in which the check valves are flapper valves mounted to the lower surface of the header.

17. The container as claimed in claim 16, in which the two flapper valves are formed from an integral plastic member, the center part of which is attached to the lower surface of the header.

18. A sample handling container for use with capillary tubing lengths carrying precise quantities of liquid therein and comprising A. an imperforate bag of flexible sheet material having insulating qualities, and being impervious to the samples to be contained therein,

B. an elongate relatively rigid header of insulating material impervious to the samples to be contained in said bag and having the bag secured thereto to depend therefrom when the header is arranged with its longer dimension horizontally, said header having i. a central elongate chamber therein having an entrance at one end of the header and an outlet end at the opposite end thereof, said chamber being formed of dimension enabling receipt entirely therein of at least one capillary tube so as to occupy substantially the transverse area of the chamber so that liquid introduced at said entrance will, to some substantial extent, flow through the bore of said capillary tube,

ii. a first passageway connecting said chamber to the interior of the bag at said outlet end, and the bag being otherwise fully enclosed, whereby any liquid forced into said entrance will pass into and be accumulated in said bag, and in so passing will flush the bore of the tubing if same is disposed in said chamber,

iii. and antiblocking means at said outlet end of said chamber to maintain flow from said outlet, and

C. blocking means for preventing the escape of liquid in said bag by way of said first passageway and chamber.

19. The container as claimed in claim 18 and means in the header for selectively withdrawing liquid from the bag, said means comprising a vertical passageway in the header opening to the upper side of the header when oriented with the bag in depending condition, said vertical passageway being aligned with said first-mentioned passageway so that a dip tube may be inserted through said vertical passageway into the bag to remove a quantity of sample, and means for normally obstructing said vertical passageway.

20. The container as claimed in claim 18 in which said blocking means comprise a one-way check valve in the first passageway where it opens to said bag interior.

21. The container as claimed in claim 18 in which said flexible bag comprises a tubular length of plastic sheeting having a sealed bottom end and an upper open end defining an open mouth, said upper end having a circumferential dimension somewhat smaller than the peripheral dimension around the lower edge of the header taken along its length, said upper end being tightly and sealingly engaged over the lower edge of said header, said first passageway having an outlet at the surface of the lower edge of the header and within the mouth of said bag.

22. The container as claimed in claim 21 in which said blocking means comprise a one-way flapper valve mounted to the lower edge of the header normally closing said passageway and adapted to open into said mouth to provide entry to said bag from said outlet.

23. The container as claimed in claim 22 in which said first passageway is in the lower part of said header and means to enable withdrawal of liquid from the bag comprising a second passageway in the upper part of said header in axial alignment with said first passageway and having an opening to the upper side of said header, said second passageway normally being obstructed to prevent escape of liquid therethrough, but

adapted to receive a dip tube thereinto for withdrawal of llqllld from said bag, said second passageway having an obstructing means capable of being overcome by an inserted dip tube so that the dip tube may be inserted from the upper side of the header, through both passageways and into the bag.

24. The method of diluting and providing for testing of a liquid sample made up of a liquid concentrate and a liquid diluent, the concentrate having previously been entrained as a known volume in a length of capillary tubing comprising: mounting said length in a container which has an enclosed flexible bag and a tubing supporting header having a communication passageway between header and bag, the length of capillary tubing being disposed in the header, forcing a known volume of diluent into the header so that a portion thereof washes through the hollow bore of the length of capillary tubing and flows into the bag, closing off the container, manipulating the container and withdrawing a portion of the resulting mixed liquid through a wall of the container.

25. The method as claimed in claim 24 in which the container is made out of a resinous material that is nonreactive to high-frequency radiation and the said mixed liquid is heated by subjecting the entire container and contents to highfrequency radiation before withdrawing a part of said mixed liquid.

26. The method as claimed in claim 24 in which the wall of the container through which the portion is withdrawn is a part of the bag, and the withdrawing is done by piercing the bag without otherwise opening the container.

27. The method as claimed in claim 26 in which a hollow pointed instrument is used to pierce and withdraw.

28. The method as claimed in claim 24 in which the wall of the container through which the portion is withdrawn is a part of the header and is provided with a second normally blocked passageway.

29. The method as claimed in claim 28 in which the withdrawing is done by a hollow dip tube which is inserted in said second passageway and unblocks the same while being moved into the bag, opening the container while so inserting and moving.

Claims

2. The container as claimed in claim 1 in which the blocking means comprises a one-way check valve for blocking said passageway and cavity flow out of the bag while permitting flow into the bag.
3. The container as claimed in claim 1 in which the blocking means comprises a removable plug inserted into the entrance end of said cavity.
4. The container as claimed in claim 1 and an identification card, means carried by said header for mounting said identification card removably thereon so that said card will accompany the container during the processing of the sample introduced therein, said header having a vertically arranged slot therein spaced laterally from said bag and said identification card is capable of being inserted and held in said slot.
5. The container as claimed in claim 4 in which said slot is arranged parallel to an elongate edge of said header and has the center portion thereof open to said edge so that said identification card may be buckled to pass through said open portion and released to engage the closed ends of the slot.
6. The container as claimed in claim 5 and said identification card being of sufficient flexibility to permit buckling and recovery thereof and having lateral notches engaged in the ends of the slot
7. The container as claimed in claim 6 in which the notches in the card are generally angular and the slot ends have configurations which substantially conform to the shapes of said notches.
8. The container as claimed in claim 1 and means in the header to enable withdrawal of a quantity of liquid from the bag, said means comprising a normally obstructed conduit in said header, aligned with said passageway, for permitting the introduction of a dip tube into said bag for said withdrawal of a quantity of liquid from said bag.
9. The container as claimed in claim 8 in which said header has a hollow riser protruding from the upper side thereof, said normally obstructed conduit including the hollow bore of said riser, and the upper end of said hollow bore having a piloting entrance capable of guiding entry of said dip tube therein.
10. The container as claimed in claim 8 in which said normally obstructed conduit has a sealing plug therein which is capable of being pierced by said dip tube.
11. The container of claim 10 in which said sealing plug is of elastomeric material and has a diaphragm at the location where it will be pierced.
12. The container as claimed in claim 11 in which said header has an upper surface all of which lies substantially in the same plane and said normally obstructed conduit has an Opening which opens to said upper surface with said sealing plug comprising a stopper engaging in said opening and having a portion telescoped within said conduit, said diaphragm being in said telescoped portion.
13. The container as claimed in claim 1, and means in the header for selectively withdrawing liquid from said bag comprising a second passageway opening at its upper end to the upper surface of the header, extending from said upper surface of said header to the lower surface of said header, said second passageway having its lower end opening to said lower surface, and second blocking means for preventing inadvertent loss of liquid from said bag by way of said additional passageway.
14. The container as claimed in claim 13, in which both blocking means comprise first and second check valves.
15. The container as claimed in claim 14 in which the second check valve is mounted at the lower surface of the header and constructed normally to block the lower end of said additional passageway. 16 The container as claimed in claim 15, in which the check valves are flapper valves mounted to the lower surface of the header.
17. The container as claimed in claim 16, in which the two flapper valves are formed from an integral plastic member, the center part of which is attached to the lower surface of the header.
18. A sample handling container for use with capillary tubing lengths carrying precise quantities of liquid therein and comprising A. an imperforate bag of flexible sheet material having insulating qualities, and being impervious to the samples to be contained therein, B. an elongate relatively rigid header of insulating material impervious to the samples to be contained in said bag and having the bag secured thereto to depend therefrom when the header is arranged with its longer dimension horizontally, said header having i. a central elongate chamber therein having an entrance at one end of the header and an outlet end at the opposite end thereof, said chamber being formed of dimension enabling receipt entirely therein of at least one capillary tube so as to occupy substantially the transverse area of the chamber so that liquid introduced at said entrance will, to some substantial extent, flow through the bore of said capillary tube, ii. a first passageway connecting said chamber to the interior of the bag at said outlet end, and the bag being otherwise fully enclosed, whereby any liquid forced into said entrance will pass into and be accumulated in said bag, and in so passing will flush the bore of the tubing if same is disposed in said chamber, iii. and antiblocking means at said outlet end of said chamber to maintain flow from said outlet, and C. blocking means for preventing the escape of liquid in said bag by way of said first passageway and chamber.
19. The container as claimed in claim 18 and means in the header for selectively withdrawing liquid from the bag, said means comprising a vertical passageway in the header opening to the upper side of the header when oriented with the bag in depending condition, said vertical passageway being aligned with said first-mentioned passageway so that a dip tube may be inserted through said vertical passageway into the bag to remove a quantity of sample, and means for normally obstructing said vertical passageway.
20. The container as claimed in claim 18 in which said blocking means comprise a one-way check valve in the first passageway where it opens to said bag interior.
21. The container as claimed in claim 18 in which said flexible bag comprises a tubular length of plastic sheeting having a sealed bottom end and an upper open end defining an open mouth, said upper end having a circumferential dimension somewhat smaller than the peripheral dimension around the lower edge of the header taken along its length, said upper end being tightly and sealingly engaged over the lower edge of said header, said first passageway having an outlet at the surface Of the lower edge of the header and within the mouth of said bag.
22. The container as claimed in claim 21 in which said blocking means comprise a one-way flapper valve mounted to the lower edge of the header normally closing said passageway and adapted to open into said mouth to provide entry to said bag from said outlet.
23. The container as claimed in claim 22 in which said first passageway is in the lower part of said header and means to enable withdrawal of liquid from the bag comprising a second passageway in the upper part of said header in axial alignment with said first passageway and having an opening to the upper side of said header, said second passageway normally being obstructed to prevent escape of liquid therethrough, but adapted to receive a dip tube thereinto for withdrawal of liquid from said bag, said second passageway having an obstructing means capable of being overcome by an inserted dip tube so that the dip tube may be inserted from the upper side of the header, through both passageways and into the bag.
24. The method of diluting and providing for testing of a liquid sample made up of a liquid concentrate and a liquid diluent, the concentrate having previously been entrained as a known volume in a length of capillary tubing comprising: mounting said length in a container which has an enclosed flexible bag and a tubing supporting header having a communication passageway between header and bag, the length of capillary tubing being disposed in the header, forcing a known volume of diluent into the header so that a portion thereof washes through the hollow bore of the length of capillary tubing and flows into the bag, closing off the container, manipulating the container and withdrawing a portion of the resulting mixed liquid through a wall of the container.
25. The method as claimed in claim 24 in which the container is made out of a resinous material that is nonreactive to high-frequency radiation and the said mixed liquid is heated by subjecting the entire container and contents to high-frequency radiation before withdrawing a part of said mixed liquid.
26. The method as claimed in claim 24 in which the wall of the container through which the portion is withdrawn is a part of the bag, and the withdrawing is done by piercing the bag without otherwise opening the container.
27. The method as claimed in claim 26 in which a hollow pointed instrument is used to pierce and withdraw.
28. The method as claimed in claim 24 in which the wall of the container through which the portion is withdrawn is a part of the header and is provided with a second normally blocked passageway.
29. The method as claimed in claim 28 in which the withdrawing is done by a hollow dip tube which is inserted in said second passageway and unblocks the same while being moved into the bag, opening the container while so inserting and moving.