Title:
Biological specimen collectors and method
United States Patent 3923040


Abstract:
Biological specimen collectors, and more particularly devices for guiding such specimens into a container having a peripherally rimmed opening, one embodiment of which comprises a tube made from supple, elastic material, one end of which may be affixed to the outside of such a peripheral rim, in combination with a retaining band, whereby, after a specimen is guided into the container, the wall of the tube may stretched `drum-head` style over the opening to effect closure of the opening with the closure secured in position by means of the retaining band.



Inventors:
BEACH JANET
Application Number:
05/482161
Publication Date:
12/02/1975
Filing Date:
06/24/1974
Assignee:
BEACH; JANET
Primary Class:
Other Classes:
4/144.2, 4/144.4, 141/338
International Classes:
A61B10/00; A61B10/02; (IPC1-7): A61B10/00
Field of Search:
128/2F,DIG.5,295,272,275 4
View Patent Images:
US Patent References:
3815646INFLATABLE FUNNEL1974-06-11Coakley
3711871SANITARY LIQUID SPECIMEN COLLECTOR1973-01-23Sherin
3643266PORTABLE WASTE RECEPTACLE1972-02-22Black
3579652N/A1971-05-25Ericson
3518164DIAGNOSTIC SPUTUM COLLECTION SYSTEM1970-06-30Andelin et al.
3459174METHOD AND APPARATUS FOR COLLECTING A CLEANER URINE SPECIMEN1969-08-05Walker
3033222Portable urine collecting device with overflow handle1962-05-08Connolly



Primary Examiner:
Howell, Kyle L.
Attorney, Agent or Firm:
Rhines, Esq. William G.
Claims:
I claim

1. A container for collecting and storing specimens of material having an access opening with a peripheral rim on which is positioned one end of a tube for guiding specimens of material into said container, which tube is made from supple elastic material which is impervious to the specimens to be gathered, and a closure member comprising a closed elastic loop whose inside circumference in the unstretched state is smaller than the outside circumference of said tube positioned on said rim with a portion of the wall of said tube stretched over said opening in drumhead fashion and with parts of said wall of said tube adjacent said portion retainably enclosed about said rim by the positioning of said closure member thereon.

2. The device described in claim 1 including opening means positioned in the end of said tube farthest from said container for retaining said end in open position, which opening means is in the form of a hollow structure, the cross-sectional area of the top of which is smaller than that of the bottom, the top and bottom of which are open and the top of which faces toward said container.

3. The device described in claim 2 including an insert means for removable insertion into said opening means, the exterior lateral walls of said insert means conforming substantially to the interior lateral walls of said opening means, the end of said insert means which is farthest within said opening means when said insert means is positioned within said opening means being closed

4. The device described in claim 2 wherein said opening means is in the form of a conic section.

5. The device described in claim 3 wherein said opening means is in the form of a conic section.

6. A method of effecting closure of a biological specimen collector container having a peripherally rimmed access aperture therein and a collector tube made from supple, elastic, substantially impervious material which is affixed to the outside of said rim, comprising the steps of

Description:
BACKGROUND OF THE INVENTION DD

Frequently it is desired to collect and store samples. Thus, for example, when a child is delivered, it is common practice to sever the umbilical cord and to take a blood sample from it for test purposes. Another example of a case where it frequently is desired to take fluid samples from the human body is in the field of urinalysis; still another example is a collection unit to receive tissue samples, commonly known as biopsy. However, certain practical problems have been presented in such cases. To begin with, typically the mouth of the collection container has been small, making it very difficult to catch the desired sample. Furthermore, the actual handling and use of the container, as when its mouth is juxtaposed to an orifice of the body in the process of collecting a sample, can cause contamination of the tube in such a fashion that during subsequent exposure of the sample to the surface, as when the sample is poured therefrom, it may become contaminated to such an extent as to effectively invalidate any analytical results of tests made on the sample. Additionally, in certain types of sample taking, apparatus available prior to the advent of the present invention wasn't adequate to permit the convenient taking of representative samples. Thus, in the field of urinalysis, it is known that the composition and density of the contents of the human bladder tends toward stratification. Thus, for example, heavy sediments collect at the floor of the bladder, to such an extent that if a sample were taken comprised of the first portion evacuated, it rarely would be representative of the composition and/or concentrations of the material actually being separated from the blood by the kidneys. For this reason, it is desirable that such samples be taken after a sufficient portion of the total evacuation has taken place to ensure that the sample collected is of the more representative composition found at intermediate levels which have accumulated in the bladder.

Accordingly, it is an object of the present invention to provide an inexpensive and effective means for collecting and/or storing samples of materials, particularly from the human body, such as blood, urine, tissue, sputum, feces, etc.

Another object of the present invention is to provide such a means which can be easily adapted for a variety of variant utilizations in materials collection, such as the "mid-stream" collection of urine samples.

Still another object of the present invention is to provide a material collection means which will ensure against contamination of any sample so collected by spurious or otherwise unwanted contaminants.

SUMMARY OF INVENTION

Desired objects may be achieved through practice of the present invention, one embodiment of which comprises a flexible tube affixed to the mouth of a container, the other end of the tube being retained open by means of a conical sleeve inserted therein; whereby, after the desired sample has been taken, part of the wall of the tube may be stretched over the mouth of the tube and so retained in position by means of an elastic band or other cap-like enclosure, after which the remainder of the tube with its insert may be severed off by cutting, and discarded.

DESCRIPTION OF FIGURES

This invention may be more clearly understood from the description which follows, and from the attached drawings in which

FIG. 1 illustrates one embodiment of the present invention,

FIG. 1 A illustrates a step in the use of the embodiment of the present invention illustrated in FIG. 1,

FIG. 1 B illustrates a further step in the use of the embodiment of the present invention illustrated in FIG. 1,

FIG. 1 C illustrates a further step in the use of the embodiment of the present invention illustrated in FIG. 1,

FIG. 2 illustrates another embodiment of the present invention,

FIG. 2 A illustrates a step in the use of the embodiment of the present invention illustrated in FIG. 2, and

FIG. 2 B illustrates a further step in the use of the embodiment of the present invention illustrated in FIG. 2.

DESCRIPTION OF PREFERRED EMBODIMENTS

Referring first to FIG. 1, there is illustrated apparatus 10 comprising an embodiment of the present invention, comprising a container 12, which in this illustration is a centrifuge tube of known construction per se, a tube 14 with one of its ends 16 affixed to the mouth of the container 12 and the other of its ends 18 distended and retained open by means of an opening means 20. As noted above, the container in this illustration is a centrifuge tube of known per se design, which typically may be made from glass pyrex, plastic, or other material which is sterilizable, strong, and preferably transparent, and inexpensive, although the present invention may also be practiced in combination with a variety of other containers, including test tubes, flasks, beakers, and the like

The tube 14 preferably is made from rather thin supple, elastic material, which can easily and effectively be pulled over the opening of the container, preferably in stretched condition, as a kind of "drum-head", i.e., with its inside substantially flush with the entire top of the rim of the opening to ensure against leakage of the contents from the container, and to ensure against leakage into the container of contaminants, germs, etc., which might contaminate the contents of the container as they are poured over the lip. It should also be made from material chosen for substantial impermeability and chemical inertness to the materials to which it is to be exposed. Another desirable property for the tube, and of the cap hereinafter described when such is utilized, is good mechanical integrity, so that it may be pierced, for example with a hypodermic needle or a tube, to extract samples of material without having to break the sterile seal, with assurance that the hole so pierced will close up again when the object is removed, and that it will not split open during such processes. Latex has been found to be well suited as a tube material for such uses, but obviously a wide variety of rubbers and other elastomers, as well as plastics and other materials might also be so used.

Although it may be desirable in certain instances to bond the end 16 of the tube 14 to the outside of the container 12 by use of adhesives or other fastening means, it is also possible to make the tube 14 of such sufficiently small diameter that merely by virtue of its size and elasticity, a firm, tight, and substantially leak-proof relationship will exist between the inner wall of the tube 14 and the outer wall of the container 12. The opposite end 18 of the tube 14 is distended into a wide orifice and retained open by means of opening means 20. As illustrated, this opening means 20 preferably is a tube in the form of a right section of a cone to provide for a funnel-like action in offering a wide mouth for collection of material and channeling the flow of such material into the narrower tube 14 and thence into the container 12. Of course, it might be cylindrical instead, or even of any of a variety of cross-sections other than round, to adapt the apparatus to peculiarities of usage. Preferably, the opening means 20 is made from rather strong, fairly rigid material, such as plastic, paper, metal or the like, Generally plastic is preferred, however, because it is inexpensive, easily formed, sterilizable, inert to most chemical exposures, and pleasant appearing. The opening means 20 desirably has a ring 19 formed on the outside periphery, which serves as an anchor to hold the end 18 of the tube 14 in position where it won't slip off of the means 20.

In use, material to be collected, such as blood, sputum tissue, urine, etc., is caused to enter the wide-mouthed opening means 20, and to pass from there through the narrower tube 14 and into the container 12. Following such collection, as illustrated in FIG. 1 A, the tube 14 is pulled to one side so that a portion of the wall of the tube 14 lies flat, "drum-head" style, over the opening in the container 12, with the inside of that portion of the wall of the tube 14 flush with substantially all of the top of the opening. Then, as is further illustrated in FIG. 1 B, a means 30 to retain the wall of the tube in such sealing position, such as a ring, or a cap (notshown) of material which preferably is elastic, as a rubber band, is placed over the tube 14 and the peripheral rim of the opening. Following this, the balance of the tube 14 and its associated opening means 20 man be severed off, as by cutting with a knife or scissors, and discarded, leaving the container as illustrated in FIG. 16, with label 40 thereon, and ready to be placed in a centrifuge rack, or other processing, storage, or handling component, with its end sealed but still such that samples may be withdrawn from the container by hypodermic needle, tube, or other means, without disturbing the biological state of either the sample or the tube interior.

It will be apparent that apparatus of the type herein described is ideally suited to be sterilized and packaged in that condition, and that in use, biologically or chemically foreign substances come into contact with the contents of the material in its container either as it enters, is retained in, or is removed from the container since the sample "sees" only sterilized surfaces. Thus, the analytical and biological integrity of the collected specimens may be preserved. It will also be apparent that such apparatus may be made from constituents which are so inexpensive and effective, that "throw-away" packages which are both technically and commercially feasible may be so produced.

FIG. 2 illustrates another embodiment of the present invention which includes, in addition to those elements comprising the embodiment illustrated in FIG. 1, an insert 24 in the form of a cup-like device having a closed end 26 and side walls which may be made from materials of the same type and selected on the same basis as those comprising the opening means 20, and the outside of which conforms substantially with the inside 28 of the opening means 20. It also includes an annular ring 25 positioned the outside circumference of the insert 24. This ring 25 is particularly useful to keep the insert 25 from dropping too far into the opening means 20 when it is positioned therein as hereinafter described. It will be seen that the ring 25 corresponds to the flange 19 on the opening means 20, and that the two pieces, i.e., the opening means 20 and the insert 24, may be produced with the same tooling; the bottom of the opening means 20 thereafter being removed. As illustrated in FIG. 2 A, this insert 24 may be positioned within the opening means 20, thereby closing off access to the container 12 for a quantity of material equal in volume to the volume of the insert 24.

This embodiment is particularly useful in connection with such things as the "mid-stream" collection and storage of materials for example, where it is desired to select out certain portions of the material to be collected from the rest of the material available. Thus, in urinalysis, for example, the first part of the sample taken which contains non-representative proportions of sediments or other concentrations, may be caught in the insert 24. After a sufficient amount of material 28 has been passed to ensure that the composition has become representative, the insert 24 may be removed as shown in FIG. 2 B, without interruption of the evacuation process, following which the material, in this case urine, will flow through the opening means 20 and the tube 14 into the container 12, from which point on, as is illustrated in FIGS. 1 A through 1 c. Such an embodiment is particularly useful, for example, in collecting urine samples from bed-ridden female patients.

It should be understood that the embodiments of the present invention herein illustrated and described are by way of illustration but not of limitation, and that other embodiments may be made by those skilled in the arts without departing from the spirit or scope of this invention.