Disposable Specimen Collection And Analysis Bag

Abstract

A flexible sealed bag for containing and analyzing a specimen, comprising: an entrance; a first reservoir, communicating with the entrance, which receives specimen through the entrance; manually actuatable sealing means between the entrance and the reservoir; with a solid specimen, a liquid solvent in the reservoir into which the specimen becomes mixed; a narrow channel connecting the reservoir with an analysis chamber for permitting liquid in the reservoir to pass into the analysis chamber; the channel from reservoir to analysis chamber including manually actuatable sealing means for closing off the channel after adequate liquid has passed from the reservoir into the analysis chamber; the analysis chamber already holding a substance for reacting with the liquid transferred thereto; whereby a liquid specimen is divided into two parts, the part in the reservoir and the part in the analysis chamber.

Description

This invention relates to a container in which a portion of a liquid specimen, of a gaseous specimen or of a solid specimen that has been dissolved in liquid, is stored and another portion of the specimen is reacted with another substance, and particularly relates to such a container comprising a flexible bag which is used in the collection and analysis of body fluids such as urine.

It may be desired to react a liquid, or gaseous, collectively referred to as fluid, or solid specimen with another substance. If this reaction is inconclusive or indicates a situation meriting further investigation, it may be desirable to have additional specimen available for a subsequent reaction or analysis. However, specimens may sometimes be available only on infrequent occasions. For example, in the analysis of body fluids, such as urine, specimens are not readily obtained and it is desirable to use one specimen for all tests to be performed. Furthermore, it may be desirable to perform a number of separate analysis procedures in a single specimen.

The most common specimen collection apparatus is a simple single chamber collection vessel which holds all of the specimen collected from a single source. Different operations are performed on different portions of the specimen after the specimen has been parceled out to separate containers.

Collecting a specimen in a single container and then transferring portions of the collected specimen to different containers for different reaction procedures creates the possibilities of mix-up in identification of specimens, and of contamination from the air and from the use of a multiplicity of containers. Thus, it is most desirable to limit the number of specimen containers, while remaining able to perform all necessary reaction procedures and while ensuring that there is a sufficient quantity of specimen left over for subsequent reactions.

In other prior art specimen collection apparatus, a specimen is divided among a number of separate chambers in a single specimen receiving vessel. It is also known to seal off the chambers of the vessel from each other after division of the specimen. It is conventional to thereafter add additional substances to at least one chamber of the vessel to bring about a particular reaction. It is also known to permit transfer between the chambers in such a vessel.

The prior art does not show means for providing an accurate uncontaminated reaction with one portion of a fluid or solid specimen while providing a container for holding another portion of the specimen for future or other use. Also, the prior art does not teach the provision of a substance to react with a portion of the specimen, which reacting substance is held in a manner which prevents contamination of the portion of the specimen not involved in the initial reaction. The prior art contemplates the addition to the vessel of a substance to react with a portion of the specimen only after the specimen has been placed in the analysis vessel. Furthermore, the prior art does not show simple means for forming a single specimen containing vessel into at least two chambers and for then permitting separation of the vessel into its separate chambers so that the chamber, on whose contents a reaction is not immediately to be performed, can be stored at a location remote from the specimen portion on which a reaction is being performed. Additionally, the prior art teaches the provision of reusable, and thus specimen contaminating, vessels rather than single use disposable vessels.

The present invention overcomes the foregoing drawbacks of the prior art by providing a disposable, flexible, sealed specimen collecting bag having at least two chambers. The specimen entrance communicates with a reservoir for storage of some of the specimen. A sealing means may be provided between the entrance to the bag and the reservoir to permit the reservoir to be completely sealed off at one end from the entrance to the bag.

When the specimen is a solid specimen, the reservoir is provided with a solvent which mixes with and holds the solid specimen to make it thereafter a liquid specimen. The solvent may be held in a sealed container within the reservoir, which container may be opened by appropriate manipulation of the reservoir portion of the flexible bag. The present invention may also be used with a solid specimen that is permitted to remain in its solid, e.g. powdery, state until it is finally reacted with a reaction substance, as described below.

When the specimen is gaseous, the construction of a bag in accordance with the present invention would be substantially the same as for a liquid specimen, except that the various entrances, channels, seals and reaction substances described herein would have to be designed for receiving, passing and blocking the flow of a gas and for reacting with the gas.

The reservoir of the specimen collecting bag communicates through a narrow channel with a reaction chamber in which a reaction is to occur between a specimen and a reaction substance that has already been placed in the chamber. The channel between the reservoir and the reaction chamber is provided with preferably manually actuatable sealing means which permits the channel to be open so that the specimen might pass from the reservoir to the reaction chamber and which is actuatable so as to seal the channel after there has been adequate specimen transfer. With the channel sealed, there are now two separate portions of specimen. The specimen within the reaction chamber can be reacted with another substance while the portion of the specimen in the reservoir will not be affected by this reaction and, therefore, is available if subsequently needed. The reaction between the specimen and the substance to be reacted with the specimen takes place in the reaction chamber within the bag itself.

With the bag just described, it is possible for an operator in the field to do an immediate test on a portion of a specimen while the remainder of the specimen remains available for later use, if needed. For example, a nurse can do an analysis of a urine specimen immediately after the specimen is taken, e.g. at a patient's bedside, before the specimen changes in its characteristics. The specimen portion in the reservoir is available should further testing be required. Previously, a nurse or attendant had to take a specimen to a laboratory for analysis, and there was no way of accurately determining either the time interval between the taking of the specimen and its analysis or the original condition of the specimen when taken.

Should it be desirable, once the reaction chamber has been sealed off from the reservoir, these two portions of the bag might be separated, with the specimen holding reservoir being stored for other or future use while a reaction is being carried out on the specimen portion held in the reaction chamber should the specimen contain a continuously changing substance e.g. a bacteria culture in a urine specimen, and should it be desired to measure that continuously changing substance at a particular instant of time, while a reaction is being performed on the specimen portion in the reaction chamber, the reservoir can be stored in a manner which prevents further changing, e.g. urine would be kept refrigerated. In the prior art, when a portion of a specimen is tested, the remainder, if any, usually cannot readily be held in a manner that prevents continuing change in the substance being tested in the specimen. Thus, the provision of a readily sealable, severable, and storable reservoir as part of the specimen receiving vessel aids in the testing of certain changing specimens. This has the added benefit of avoiding the need for obtaining a new supply of specimen from the original specimen source, should further testing be required. Thus, for example, a person would only have to supply a single urine specimen to have a bacteria culture therein analyzed and reanalyzed later.

It is contemplated that at the time of manufacture of the bag, the reaction chamber will be provided with a charge of the substance that is to be reacted with the specimen after the specimen is received by the bag. For example, the reaction substance might be stored in a sealed receptacle in the reaction chamber. The seal on the receptacle could be broken after the reaction chamber has been sealed off from the reservoir. Alternatively, the substance to react with the specimen might mix so slowly with the specimen itself that the reaction chamber could be sealed off before any of such substance would improperly migrate into the reservoir. Other ways of keeping the substance to be reacted with the specimen in the reaction chamber and for preventing it from exiting from said chamber into the reservoir should be apparent to those skilled in the art.

The provision of delayed release reaction substance receptacles permits simultaneous accurate analyses of a multiplicity of samples taken at different times. It also permits a reaction to be delayed until a changing specimen has attained the state at which it is to be tested.

As an example of these benefits, a specimen, once collected, may have to be incubated for a fixed period to bring it to a state at which it is to be analyzed, e.g. bacteria may take 4 hours to develop to a particular concentration. When each specimen is taken, a portion of it can be transferred from the bag reservoir to the bag reaction chamber. All seals are closed and the bag is immediately refrigerated. All bags collected over a period of time can have the sealed reservoir simultaneously removed and again stored in the refrigerator. The sealed reaction chambers can then be incubated all at one time under conditions that are readily controlled. Then the reaction substance receptacles can all be manipulated to release their contents and bring about the desired reaction in each bag. Because the reaction substance receptacles can hold their contents for a prolonged period, no premature reactions occur.

With the bag of the present invention, since the specimen is all transferred directly into a single bag, since the reaction on the first portion of the specimen takes place in that bag, since the substance to be reacted with the specimen has previously been provided in the bag and, therefore, might be placed in there under sterile conditions to prevent contamination, since a second portion of the specimen may be stored in a reservoir that is sealed off from the first portion of the specimen which is being reacted with another substance in the reaction chamber, since the bag is disposable after one use and is not reusable, and since there can be a minimal number of transfers of specimen to different containers, the specimen will not be contaminated, there is little likelihood of loss of a portion of a specimen due to accident and there is little likelihood of mix-up or misidentifications of specimens.

The reaction chamber of the present invention is described as being only a single chamber. It is within the contemplation of the invention, however, to provide a plurality of reaction chambers, arranged in series one after the other, or in parallel with each communicating directly with the reservoir through its own separate channel. If the reaction chambers are arranged in series, they are joined by channels, each containing a separate sealing means. If they are connected in parallel, channel means connect each of the chambers and each is filled and sealed off in the manner described above for a single reaction chamber.

The present invention will be described in connection with a body fluid collection and analysis bag and particularly a urine collection and diagnostic bag. It is to be understood that the present invention may be used in conjunction with any fluid or solid specimen and with any reaction that is performed on any specimen.

Accordingly, it is a primary object of the present invention to be able to divide a single fluid or solid specimen into a number of separate portions each to be treated in a different way.

It is a further object of the present invention to provide a single bag in which a first portion of a specimen can be reacted with another substance and in which a second portion of the specimen can be stored for future and other use.

It is another object of the present invention to minimize contamination of a specimen.

It is another object of the present invention to minimize the chances of a specimen being lost or mixed up.

These and other objects of the present invention will become apparent from the following description of the accompanying drawings in which:

FIG. 1 is a front view of a bag designed in accordance with the present invention;

FIG. 2 is a fragmentary view of a bag having a reaction substance in an alternate form;

FIG. 3 shows an alternate form of top for a bag designed in accordance with the present invention;

FIG. 4 is a view in the direction of arrows 4 of FIG. 3;

FIG. 5 is a view in the direction of FIG. 3 with the bag being open;

FIG. 6 is a view in the direction of arrows 6 in FIG. 3;

FIG. 7 is a view of an alternate embodiment of a bag designed in accordance with the teachings of the present invention; and

FIG. 8 is a front view of a bag designed in accordance with the present invention for use with solid samples.

Referring to the Figures, and particularly FIG. 1, bag 10 is a sealed, flexible vessel which is comprised of a material, e.g. conventional polyethylene plastic, that is inert to the liquid specimen, to the substance to be reacted therewith and to the reaction product. The bag is flexible to permit manual actuation of bag sealing means and/or solvent or reaction substance retaining means, described below, and to permit manipulation of reaction substances, as described below. However, the bag need not be flexible, so long as it has the qualities described below.

Sealed bag 10 has an entrance 11 for permitting urine to enter the bag. Where the urine specimens are being taken from young children, it is often difficult to obtain the specimen when it is desired to collect it. Accordingly, entrance 11 is surrounded with a band of adhesive material 12 which would adhere to the body of the child to hold the bag in place until the specimen is provided. From entrance 11, the urine passes through an entrance chamber 14, past reservoir sealing means 16 and into reservoir 18.

After sufficient liquid specimen has passed into and through, as described further below, reservoir 18, it is frequently desirable to seal off the reservoir from the bag entrance, thereby to prevent specimen from improperly exiting from the reservoir and to prevent contamination of the specimen in the reservoir. A conventional sealing means 16 seals off entry portion 14 from reservoir 18. For example, sealing means 16 might comprise a band of adhesive around the interior wall of the bag. To actuate the sealing means, the flexible bag is manipulated and the adhesive band is squeezed shut and adheres to itself.

Reservoir 18 is merely a container for holding liquid specimen. Channel 20 connects reservoir 18 with reaction chamber 22, to be described further below. Channel 20 is defined by a block 24 of impermeable material through which the channel passes. Channel 20 has cross-sectional dimensions such that liquid specimen would not readily pass through it. Thus, after sealing means 16 has sealed off reservoir 18 from entry chamber 14, then bag 10, and specifically reservoir 18, is manipulated so that some of the liquid within the reservoir is forced through channel 20 into chamber 22. By manipulating only reservoir 18, specimen flows only into chamber 22 and not back into reservoir 18, thereby preventing contamination of the contents of reservoir 18 with any of the materials within reaction chamber 22.

The dimensions of the reaction chamber 22 portion of bag 10 may be so chosen that chamber 22, when filled with specimen, is holding a predetermined volume of liquid specimen. Thus, when the specimen in chamber 22 is reacted with a reaction substance already within the chamber, both a qualitative and a quantitative analysis of the reaction with the liquid specimen in the reaction chamber 22 can be performed.

Channel 20 is also provided with a manually actuatable sealing means for enabling the channel to be sealed after sufficient specimen has been transferred into chamber 22. If the material of plug 24 is sufficiently flexible to permit it, the walls of channel 20 may be coated with an inert adhesive which adheres to itself when the walls of the channel are squeezed together. Alternatively, other sealing means known in the art may be used. The sealing means prevents undesired back transfer. Furthermore, should it be desired to separate the reaction chamber 22 from the reservoir 18, the sealing means seals off the chamber to prevent leakage.

When bag 10 is being manufactured or prior to its being put into use, and especially prior to the entry of liquid specimen, a substance to react with the liquid specimen is placed in the reaction chamber 22 section of bag 10. In FIG. 1, a block 26 of reaction material is illustrated. The block of particular volume holds a predetermined quantity of reagent to react with the urine. Tests for urine and reagents to react with urine are well known in the art. See for example, "Screening Tests for Bacteria", by T. G. Sacks and J. H. Abramson, The Journal of the American Medical Association, Vol. 201, No. 1, July 3, 1967, p. 79, et. seq. Block 26 of reagent would be soluble in the urine or would be in a condition where it readily mixes with the urine. Various alternative forms for the reaction substance in chamber 22 may be used. For example, the chamber may be holding a pool of reagent in liquid form which reacts with the urine specimen as it enters the chamber from reservoir 18.

In FIG. 2, the reaction substance or reagent is held in a number of separate hollow capsules 28 which are insoluble in and impervious to the reaction substance and to the liquid specimen. The dimensions of the reagent capsules are such that they will not fit through channel 20 so that they remain within chamber 22. After channel 20 has been sealed as described above, chamber 22 is manipulated to squeeze and burst capsules 28, thereby releasing the reagent or reaction substance in the reaction chamber 22, so that it can mix with the specimen which has been transferred into chamber 22.

Alternatively, capsules 28 can be soluble in the urine at a rate sufficiently slow that reagent is now allowed to escape from the capsules until chamber 22 has received the desired charge of specimen from reservoir 18 and been sealed off.

Other techniques for storing reagent in reaction chamber 22 so that it will be available when specimen is finally transferred to this chamber are apparent to one skilled in the art.

Since the reagent is supplied prior to use of the bag, once the reagent is exhausted after one use of the bad, the bag is disposed of. This nonreusability feature minimizes specimen contamination.

At any time after specimen is in both reservoir 18 and reaction chamber 22, should it be desired to separate the reservoir from the reaction chamber, so that reservoir 18 might be stored, e.g. under refrigeration, while a reaction takes place in the reaction chamber 22, plug 24 and sealed channel 20 may be cut through along predetermined cutting path 30 by conventional cutting means thereby separating sealed chamber 22 from sealed reservoir 18. Bag 10 may be weakened along path 30 to facilitate separation. If the test performed in reaction chamber 22 shows a particular result, e.g. the presence of an undesired bacteria, the still sterile urine in reservoir 18 may be subjected to further bacterial testing. Also, should anything unforeseen damage reaction chamber 22 or the quality and purity of the specimen therein, the portion of the specimen still in reservoir 18 is available for repeat testing using the same reaction substances.

Once reservoir 18 is sealed off at sealing means 16, bag entrance 11 and entry portion 14 are no longer necessary and the bag may be cut off along predetermined cutting path 32 above the sealing means 16 thereby eliminating unnecessary material and providing a compact reservoir 18. Bag 10 may also be weakened along path 32 to facilitate separation.

In FIGS. 3-6 is shown an alternate entrance for a bag 40. Since bag 40 could be the same as the bag 10 in all other respects, only the entrance to bag 40 is described. Entrance 42 opens across the entire top of bag 40. Resilient sealing rib 44 along one side of thickened resilient cuff 43 and depression 45 along the opposite side of cuff 43 engage one another and cooperate to hold entrance 42 shut, as shown in FIG. 3. Pressure on the ends 46 of cuff 43 causes the cuff to bow into a rounded opening. Release of this pressure will permit entrance 42 to again close.

FIG. 7 shows a bag 50 which is comprised of the same elements as bag 10 except for the reaction chamber means. Sealing means 52 seals off the inlet end of reservoir 54, which reservoir has the qualities of reservoir 18. Reaction chamber means 56 includes a plurality of reaction chambers 58, 60, 62, 64, each of which is sealed off and isolated from its neighboring reaction chamber by intermediate walls 66.

Reaction chamber 58 will be described in detail, it being understood that the other chambers are substantially identical. Chamber 58 has a plug 68 of the same type as plug 24. Plug 68 has a channel 70 passing through it, which channel is of the same type as channel 20 and which channel is provided with a sealing means of the type provided in channel 20. Positioned within the reaction chamber 58 is a reaction substance 72, similar to that in bag 10. Before a reaction occurs within an individual reaction chamber, the channel into that chamber should be sealed off in the manner described above, thereby isolating the chamber completely from the reservoir 54 and from the other chambers. Once an individual reaction chamber is isolated from the others and from the reservoir, it is effectively the same as reaction chamber 22.

With the provision of a plurality of reaction chambers, rather than just one, a number of separate tests can be performed simultaneously on a single specimen, while a separate portion of that specimen is stored for other or later use in the separate sealed reservoir 54.

As with the reaction chamber 22, the reaction chambers 58-64 may be separated from the reservoir 54 by cutting across the bag 50 along predetermined cutting path 73 through the sealing plugs into each reaction chamber. Also, if the walls 68 between neighboring reaction chambers are made thick enough, it would be possible to separate neighboring chambers by cutting along the dividing wall.

In the event that the specimen is in the form of a solid, rather than in the form of a liquid, the embodiments of the present invention which are shown in FIGS. 1-7 may still be employed. If the solid specimen is already in particles that are sufficiently small to fit through the entrance to the bag and through the channel or channels leading into the reaction chamber or chambers, then, as with the liquid specimen, a portion of the solid specimen is stored in the reservoir and a portion of the specimen passes into the reaction chamber to be reacted with a reaction substance or reagent stored in the chamber. The reaction substance would have to be in a form which would mix with, dissolve and react with the solid specimen so as to provide a measurable reaction.

Should the solid specimen be in particles too large to be properly stored, passed through the channels of the bag or reacted with a reaction substance, or should it be desirable to store and work with a specimen that has been placed in liquid form, then the modified bad 80 of FIG. 8 would be used.

Bag 80 has an entrance (not shown) and a reservoir entrance sealing means 82 both of the type described above. Within the reservoir 84 is positioned a solvent holding receptacle 86, which may be a freely movable solvent filled bubble or a bubble that is secured to the interior wall of the reservoir. Usually, the receptacle 86 would be sealed to prevent leakage of reagent out of the bag 80 before the reservoir has been sealed at 82. The solvent in receptacle 86 would be any conventional solvent, e.g. water or alcohol, which is adapted to dissolve and mix with the solid substance to be analyzed. Once dissolved in liquid solvent, the solid specimen becomes identical to a liquid specimen provided for storage and reaction and the treatment of this now liquid specimen would be the same as described above. The remaining structure of bag 80 is illustrated as being similar to that shown in FIG. 2, and, therefore, it will not be described. Structures in FIG. 8 that are described with respect to FIG. 2 are correspondingly numbered to FIG. 2 with prime (') numbers.

For gaseous specimens, a modified bag structure of FIGS. 1-7 could be used. The modifications would be in the size of the bag entrance, the width of the channel between the reservoir and the reaction chamber, the type of sealing means used in the bag and the type of reaction substance, e.g. a material to absorb gas, used in reaction chamber. The necessary modifications should now be apparent to one skilled in the art.

There has just been described a novel bag for receiving and holding a single fluid or solid specimen, and for permitting a reaction to be performed on a portion of that specimen which is isolated from a second portion of that specimen which second portion is held in a sterile storage reservoir until that second portion is required.

Although preferred embodiments of this novel invention have been described, many variations and modifications will now be apparent to those skilled in the art. Therefore, this invention is to be limited, not by the specific disclosure herein, but only by the appended claims.

Claims

I claim:

1. A self-contained, integral, disposable analysis bag for permitting at least one analysis procedure to be performed on a portion of a single specimen while another portion of that specimen is isolated and stored, comprising,

a specimen entrance into said bag;

a reservoir, large enough to store a significant quantity of the specimen, communicating with said entrance for receiving, holding and storing specimen entering through said entrance;

a reaction chamber having within it a substance for reacting with specimen entering said chamber; said chamber communicating with said reservoir through a channel;

said channel including channel sealing means which may be actuated to seal said channel, thereby separating all material in said reservoir from all material in said chamber;

whereby a first portion of a specimen may pass into said chamber to react with the substance therein and a second portion of the same specimen may be held in the reservoir to be separately used as needed.

2. The specimen analysis bag of claim 1, wherein

said bag, said channel and said channel sealing means are comprised of such material and are so dimensioned that said bag may be readily severed at the vicinity of said channel sealing means to separate said reservoir from said reaction chamber.

3. The specimen analysis bag of claim 1 further comprising,

reservoir sealing means between said reservoir and said bag entrance, said sealing means being actuatable to seal said reservoir, thereby preventing entry into and exit of material from said reservoir.

4. The specimen analysis bag of claim 3 further comprising,

adhering means around said entrance for adhering said entrance to a source of specimen to permit gathering of specimen.

5. The specimen analysis bag of claim 1, wherein

said bag is comprised of flexible material such that manipulating said bag displaces said bag and the material in it.

6. The specimen analysis bag of claim 5, wherein

the substance with which the specimen is to react in said reaction chamber is stored in capsule means in said chamber; said capsule means normally holding the substance so it is out of contact with specimen in said chamber; said capsule means being operatable upon to cause release of the reaction substance from said capsule means such that the substance may react with the specimen in said chamber.

7. The specimen analysis bag of claim 1, wherein

said reaction chamber is sub-divided into a plurality of separated chambers, each having within it a substance for reacting with specimen entering that said separate chamber; all of said separate chambers communicating with said reservoir through a channel means; said channel means including channel sealing means which may be actuated to seal each said separate chamber from said reservoir and from each other said separate chamber.

8. The specimen analysis bag of claim 7, wherein said separate chambers are each isolated from one another and each includes a separate channel communicating with said reservoir; each said channel being provided with said sealing means.

9. The specimen analysis bag of claim 1, wherein the specimen is in solid form,

said reservoir containing a receptacle holding solvent for the solid specimen, whereby when solvent exits from said receptacle, it dissolves the specimen.

10. The specimen analysis bag of claim 9, wherein said solvent receptacle is sealed and is adapted to be opened to permit solvent to exit therefrom by manipulation of said receptacle.

11. A method for performing at least two separate procedures on a specimen, including the steps of,

placing a substance intended to react with the specimen in one section of a flexible bag;

placing a specimen in another section of the bag;

transferring a first portion of the specimen from the latter section to the former section of the bag;

sealing the bag in a manner which traps the first portion of the specimen in the one section of the bag;

further sealing the bag in a manner which traps the second portion of the specimen in the other section of the bag to be out of contact with the substance which is to react with the specimen so as to preserve the second portion for different use than the first portion;

operating upon the first section of the bag to bring about a reaction between the substance designed to react with the specimen and the first specimen portion.

12. The method for performing at least two separate procedures on a specimen of claim 11, including the additional step of severing the bag between the sealed section thereof in which the substance to react with the specimen is located and the other sealed section, thereby to form two separate sealed receptacles holding specimen.

13. The method for performing at least two separate procedures on a specimen of claim 11, wherein the specimen is a solid specimen and including the further steps of placing a solvent for the solid specimen in the other section of the bag prior to placing the specimen in that other bag section and dissolving the specimen in the solvent before transferring the specimen to the one section of the bag.