NO131258B - - Google Patents

Description

Disposable container for carrying out a

chemical analysis reaction.

The present invention relates to a disposable container for carrying out a chemical analysis reaction as stated in patent 127.

127, comprising at least a lower part with a reaction chamber for mixing

ing of materials introduced therein and for producing a chemical reaction between them, an upper part with storage chambers for separate storage of reagent, which storage chambers are arranged to be connected to the reaction chamber in the lower part, which is closed to the outside with the exception of its connection with the storerooms, as well as blocking

device arranged to prevent premature transfer of reagent from the storage chambers to the reaction chamber.

In the past, many routine, manual laboratory pro-

sessions have been carried out on body fluids as support for the doctor in fast-

laying, diagnosing or preventing diseases such as home-

seeking people, As the medical science has

advanced and medical chemical analyzes have become more and more complex, new laboratory processes and techniques have been developed for the analysis of such fluids in the search for a hidden clue that can establish or reject the presence of a particular disease.

At the same time that medical science has developed new test methods for the detection of special diseases, the earth's population has increased to an enormous extent. New terms such as "population explosion" have been coined to express this physical phenomenon that is currently occurring and will continue to occur in the existing male-ness. The more examinations that are carried out on each person and the more people who need such examinations, the clearer it becomes that more and more people must be trained and/or new devices must be developed to meet this tremendously increasing need.

This has been a problem for humanity for several years, and it is clear that the solution of training more qualified people to perform this ever-increasing amount of clinical analysis has not kept pace with the task. Most clinical departments are headed by a pathologist or medical technologist who supervises a trained staff of laboratory technicians. Most of the laboratory technicians are young, unmarried women who are frequently replaced due to marriage. The resulting lack of manpower therefore sets a limit both to the amount of clinical examinations that can be carried out, as well as to the quality, which due to the constantly increasing workload will be increasingly affected by human error.

In order to meet this ever-increasing need, which has not been adequately met by the expanding technical laboratory access, new devices have been developed to assist the laboratory technicians in carrying out a greater number of examinations per unit of time. Many of these devices have exclusively aimed at mechanizing or automating the purely manual operations carried out by the usual clinical chemists or analysts. Examples of such devices are shown in US patent documents 2,560,107, 3-1^3. 393, 3,193,358, 3,193,359 and 3,219,416. These deal with devices consisting of tubes, funnels, reagent containers, pumps and other associated devices to bring a particular sample and the necessary reagents together to perform a desired analysis. Although the devices undisputedly carry out several analyzes per unit of time, the devices as a whole are subject to other objections similar to those highlighted when a technician manually performs the analysis, including the repeated use of the same laboratory equipment for several distinct analyses, which raises the problem of contamination. In order to overcome these unfortunate conditions, a noticeable part of the operating time will be spent on repeated cleaning of the equipment to produce a clean environment for subsequent samples. As a result of this, the efficiency expressed in the number of samples that can be processed per unit of time drastically.

A further unfortunate feature of such devices, as well as of other previous devices, is that they are originally programmed to carry out several examinations of a single type.

This means that several samples are taken and a single examination,

for example blood sugar, is carried out at each test. The device must therefore be reprogrammed to provide for further investigations on the remaining portions of the samples. In many cases, the device cannot be reprogrammed, or the execution of the reprogramming requires significant changes or relocation of the component parts, which must be carried out by the operator. These changes reduce the device's flexibility and further reduce the improvements that can be achieved by performing purely manual methods through mechanical devices.

An earlier automatic apparatus which has achieved some degree of success is the so-called "Auto-analyzer" manufactured by the Technicon Instruments Corporation of Chauncey, New York. This apparatus is described in US patents 2,797-149 and 2,879,141, and in a number of other US patents belonging to the aforementioned company. As described in these patent documents, a liquid sample to be analyzed is passed through tubular channels and a proportioning pump, which comprises a number of elastic tubes, a pressure cylinder and a number of pressure rollers. The sample to be analyzed using one or more treatment fluids is passed through one side of a dialyzer while one or more secondary treatment fluids are passed through the other side of the dialyzer, and results in the separation of various constituents from the sample, which are passed through the dialyzer to the secondary treatment fluids. Air is introduced into both fluid streams before they reach the dialyzer to break each stream into a number of fluid segments separated by air segments or air bubbles. The air segments have been shown to

have two purposes, namely to separate the samples from each other and to produce

bring a cleansing effect between successive samples to prevent the transfer of contamination. The diffusate passing from the dialyzer is subjected to treatment to produce a color change in the liquid segments to thereby indicate the concentration of the constituent for which the sample is to be analyzed. Normally, the air or other inert fluid that has been introduced into the fluid streams to divide the fluid material is removed from the stream at a location prior to colorimetric examination, leaving a continuous fluid stream for final examination. Finally, the diffusate is directed to a flow cell in a colorimeter where it is subjected to colorimetric examination to produce a quantitative measure of the constituent being analyzed.

Currently, commercial forms of the "Auto-analyzer" include a multi-channel device that simultaneously performs several different examinations on a single sample. Although there are approximately twenty different examinations that can be performed with the apparatus, it is not possible to program the analyzer to perform any number of examinations less than the number of channels. Therefore, when a doctor requires only one or two examinations" carried out on a particular sample, the unit costs per sample are increased because the apparatus is non-selective and must perform an average analysis. Then, moreover, a plurality of different samples having different concentrations of the component to be analyzed is passed through the elastic, tubular channels, the flow cuvette, the dialyzer, etc., there is a problem with sample transfer or contamination that can have a noticeable effect on the reliability of the analytical data. To reduce contamination, the cleaning fluid is arranged in a attempt to ensure an environment free of contamination This makes an already complicated apparatus even more complicated.

During use, the proportioning pump moves the different fluids through a maze of elastic tubes. The repeated bending and continuous work of the pipes causes them to wear out very quickly, with the result that small cracks can occur. This results in areas that are more easily wetted by the p-rö vernat erial that is passed through the pipes, which increases the pollution factor for the whole apparatus as well as the operating costs due to the necessity of replacing worn out pipes. Before each operating period, there is a necessary longer warm-up period. In addition, a calibration curve must be provided each time the instrument is started up to help compensate for various deviations that may occur when the instrument is not in use, and for accurate analysis a second calibration curve must be recorded at the end of each trial to detect deviations that may perform during the operation. Finally, the preliminary analytical data, obtained by using this apparatus, for each individual sample must be correlated with the aforementioned calibration curves to produce the final analytical data in a form that can be considered reliable for the doctor. Such factors limit the overall effect of such an apparatus on clinical analyses, as a considerable amount of time is required for the technician to calibrate the apparatus and then bring the analytical data obtained therein into a reliable form.

The purpose of the present invention is to produce

a disposable reaction container that enables the performance of a large number of safe optical analyzes per unit of time.

This is achieved by the reaction chamber having two parallel side walls that are perpendicular to the bottom of the chamber, the side walls being elastic and translucent so that an optical analysis of the contents of the chamber can be carried out.

Examples of the present invention will now be described with reference to the accompanying drawings, in which: Fig. 1 shows an enlarged side view of an example of a disposable container according to the present invention.

Fig. 2 shows a top view of the disposable container in fig. 1.

Fig. 3 shows an enlarged section of the reagent-containing upper part of the disposable container in fig. 1, as the right half of the figure shows the part after the contents of one reagent storage chamber have been emptied into the reaction chamber. Fig. h shows alternative design examples of the upper part in Fig. 3. Fig. 5 shows an enlarged end view of the disposable container in fig. 1 during optical analysis.

Fig. 6 shows a perspective view of a further example

on a disposable container according to the present invention.

Fig. 7 shows a perspective view of an automatic analysis system that uses the disposable container in fig. 6. Fig. 8 shows a perspective view of an automatic analysis system where the disposable containers are carried by an elongated belt. Fig. 9 shows a section of a further example of a disposable container, where the section is taken along the section line A-A in fig. 10.

Fig. 10 shows a section of the disposable container in fig. 9, taken along the section line B-B in fig. 9-

In fig. 1 and 2, a disposable container 50 is shown which has two separate lower reaction chambers 51 and 52. Each of these chambers has a bottom wall 53, outer side walls 54, 55, 56 and inner side walls 57. As shown, the walls 54 and 56 placed vertically while the walls 55 and 57 diverge outwards towards the top of each of the respective chambers. The bottom walls 5 3 have the shape of a rectangle with slightly rounded edges and corners (although the shape is in no way critical). As the walls 55 and 57 diverge slightly from the bottom wall 53 towards the upper part of the partitioned space, the opening at the top of the partitioned space also defines a rectangle which has the same width as the rectangle formed by the bottom wall 53, but which is somewhat longer. The shape of the opening is not critical as long as it does not interfere with the introduction of sample and reagents into the reaction chamber. The sloping walls 55 and 57 channel all materials downwards towards the bottom of the unit. The side walls 54 and 56 can also slope inwards towards the bottom walls 53 and thus contribute to the channeling of material to the bottom of the reaction chamber. However, it is preferred that these walls are parallel for optical reasons. The wall portions of the divided chambers 51 and 52 terminate in a horizontal flange 58 which encircles the outer circumference of the two chambers and holds them together as a distinct unit. The flange 58 terminates in an upwardly bent edge 59 which is folded inwards to hold the reagent supply portion 61 in place on top of the horizontal flange 58. The inner walls 57 extend slightly above the plane of the horizontal flange 58 and are connected to each other along a portion 60 which thus defines a distinct barrier between the separated chambers 51 and 52.

In fig. 3, the reagent supply part 61 is shown carried by the flange 58 (not shown). The part 61 comprises an upper layer 62 which defines a number of reagent storage chambers 63 in the form of "floss hats" 66. On the lower or open part of the layer 62 is a thin, weak, restraining layer 64 to keep the reagents in place in their respective chambers. Applying a force at a point 65 will possibly cause tearing of the restraining layer 64 at a point 67 and inversion of the "floss hat" 66. Reagent or other material 68 will be emptied into the reaction chamber 52. In each reaction chamber is a magnetic stirring rod 75, for example a small cylindrical part of a stainless steel wire. If the magnetic material were to have a detrimental effect on the sample, could the stir bar be completely covered by a material that would not interfere with the analytical process, such as a full coating of glass? or plastic. With the reaction mixture in the reaction chamber, the disposable container is moved to a mixing station where an external rotating magnetic field is applied, for example by means of a rotating magnetic rod. The rotation of the magnetic rod inside the disposable container creates in the liquid material in the reaction chamber a vortex which is significantly higher along the side walls of that chamber than in the middle thereof. By regulating the rotation speed of the magnetic stirrer, it is possible to carry out a thorough mixing of the reagents with the sample as well as to clean the side walls of the reaction chamber and the lower extension of the upper part for undissolved reagents. This ensures that all reagents are present in the reaction mixture in precise amounts.

Alternative embodiments of the construction 61 can

can be seen in fig. 4, in which like numbers in the figure are used to identify parts of the construction which are identical to those previously described in connection with figures 1-3 (but not necessarily shown here in this figure). In this embodiment, it is to the . lower. part... of the restraining layer 64 laminated a further layer 70 which serves as a supporting part for the upper part 6l. The layer 70 has a number of openings 71, 72, 73 and 74 which lie directly below the chambers 63- The openings can be larger than the inner width or diameter of the chambers 63, as is the case with the opening 71, can have the same size, as for example the opening 72, or be tapered as shown at openings 73 and 74.

The part 61 is placed on the horizontal flange 58 and the barrier 60 and is held tightly in place by the overlapping edge 59 - The part can also be heat sealed or glued along the flange 58 and the barrier 60 to ensure retention of the upper part 6l in the correct position . Heat sealing is particularly applicable as shown in fig. 4, where the layer 70 may be carefully selected to provide an exceptionally secure seal along said locations. The magnetic stirring rod 75 which is placed in each chamber 51 and 52 is used for thorough mixing of the reagents with the sample as previously described. The vortex created by the magnetic stirrer at an appropriate speed cleans the side walls of the reaction chamber and around areas such as a tab 76 and the twisted "floss hat" 66. By precisely controlling the speed of rotation of the stirrer, the liquid reaction mixture can be brought into contact with these relatively inaccessible places and cleaned them for even

tually retained material.

When the apparatus is in use, the container 50 is taken from a supply magazine and taken to the sample supply station where an accurate amount

sample diluted with distilled water is measured in the separated chamber 51- This supply is carried out by spraying the sample solution through a needle which has been passed through the upper part 6l. Preferably, one of the chambers 63 is left empty and the sample to be analyzed is injected into this inverted "floss hat". The "floss hat" is then turned over,

similarly to the addition of reagents, so that the sample is transferred to the reaction chamber 51- The container containing samples is then taken to the reagent addition station where the application of a pushing force on each chamber 63 causes the reagents stored therein to empty into the associated reaction chambers. The reagent addition can be done in one operation or all in sequence. as necessary for carrying out the analysis. If the supply takes place in sequence, this can happen before, during or after the incubation. In short, the reagents can be added at any time prior to the final determination, as determined by the particular analytical method used. The container 50 is taken to a mixing station where it is kept for a period of time sufficient to ensure dissolution of all solid materials in the liquid in the reaction chamber 51 - The container is then taken to an incubation station where exact reaction conditions are communicated to the materials in the container for a period of time sufficient to to complete the desired reaction which is then measured in a detection station. It is not necessary for the incubation and mixing stations to be separate and distinct, as it is possible to have only one station in which both actions can be performed. In a detection station, as shown in fig. 5, fluorescent tubes 80 and 81 are pressed against the walls, respectively 54 and 56, in the reaction chamber. Tube 80 is connected at the opposite end to a light source (not shown) which can be filtered to produce light of a desired frequency or frequencies. The tube 81, just opposite the tube 80, is connected to a suitable detection device (not shown) for determining the light intensity passing through the liquid b landing in the reaction chamber. During the analysis in question, the tubes 80 and 81 are moved towards each other whereby the elastic walls in the container 50 will deform and assume the position shown by dotted lines. In this way, a fixed optical path L is defined between the ends 82 and 83 of the tubes 80, 81. By creating a fixed optical path L in this way, it is easier to mass produce the cuvette (that is, the disposable container)

because a certain critical feature, the optical path, has been eliminated as a strict production requirement. The optical path's delimiting device is now located in the detection station, and as expected, noticeably fewer detection stations can be manufactured than disposable containers. As a fixed optical path is defined at the detection station and will be the same for each container that is passed through it, very accurate and reliable data can be obtained with this system.

The disposable container in fig. 1-5 are used in conjunction with a dual beam detection mechanism. In one reaction chamber, as mentioned above, a solution of the material to be examined has been produced, with all the reagents that will bring the reaction mixture to the desired analytical state. The second reaction chamber contains a solution of the material to be examined, without reagents. In certain cases, one or more reagents can be added to this latter solution, provided that the reagents do not complete the reaction or otherwise have any significant influence on the optical analysis. This last solution is called "a critically incomplete blank" and will enable adjustment of the analytical system for effects of the sample and the added reagents. The second reaction chamber is pressed together to define a fixed optical path in the same way as described above in connection with the first reaction chamber. To keep the detection mechanism adjusted, standard solutions are passed through the detection mechanism from time to time, so that the latter can be automatically adjusted for deviations that occur during the operation.

In order to avoid the necessity of passing standard solutions through the detection mechanism at regular intervals, a disposable container has been produced which has three reaction chambers and a number of storage chambers connected to each reaction chamber for storing necessary reagents in connection with the use of a triple beam detection mechanism. The standard solution can be injected into the disposable container at any point in the system prior to optical analysis and will eliminate the need to pass separate standard solutions through the system. The detection mechanism will analyze the standard resolution and adjust for deviations from known values. The analyzes of the materials in the other reaction chambers are carried out in accordance with the description in the previous section. If it is desired to carry out an extremely accurate analysis and take into account every possible influencing factor, additional reaction chambers can be built into the disposable container for the introduction of such factors and their analyses. Adjustments can thus be made that will compensate for the effect these materials have on the particular analysis. Additional means are associated with the container 50 to identify the particular sample with respect to its origin and with respect to the particular examination to be performed on it. The container can, for example, have magnetic coding placed on the side, or a data punch tape can be attached to it. Associated mechanisms for applying and reading such data are well known in the field. Arrangements have also been made for correlation of such information to establish an accurate record for later reference. The container can possibly be taken to a waste station where it is pulled out of the system and discarded.

A further example of a disposable container is shown in fig.

6 where a data recording card 90 is provided on one side with an elastic container 91 divided into a number of compartmentalized compartments 92, 93 and 94. Secure sealing is arranged along the outer circumference of the container to ensure the connection between the container and the substrate. Such sealing can, for example, be carried out using a strong heat seal or a strong adhesive connection. Under the application of a moderate pressure, as described in the following, these connections will not tear apart, with the result that the container remains securely attached to the registration card. The separate compartments 92, 93 and 94 are kept separate by "weak" seals 98 which, under the application of heat, vacuum, bending or pressure, are opened to produce a single compartment in which powdered reagents are loosely mixed at the bottom, as more fully described in connection with figures 9 and 10. Such seals can either be a heat seal or a weak adhesive connection. Associated data 95 is stored on the other part of the registration card in a form that is well known to the person skilled in the art and which, in connection with associated devices in the automatic analysis device, will ensure that the correct analysis is carried out on the sample and identifies the sample and the examination results as hears a special patient. Powdered reagents 96 and 97 are stored in the compartments 93 and 94, respectively. If necessary, it is possible to store additional reagents in the lower compartment 92. The desired number of compartments is determined by the number of reagents necessary for a particular analysis and the compatibility of reagent mixtures. A number of reagents may be stored in a single compartment, provided they

are compatible through a longer storage period.

In use, one or more of the reagent storage chambers are touched to open the separate compartments and connect them to the lower compartment 92. The powdered reagents stored therein are brought to the lower reaction chamber, and diluted sample solution is injected through a needle into the latter room. Mechanical parts or fingers (not shown) can be arranged to reinforce a particularly weak seal, so that when a force is applied to the elastic container, the particularly weak seal will not be broken. In this way, selected separated rooms can be emptied of their contents in order to thereby produce elasticity in the processes that can be carried out in this system. The unit is then passed through a mixing and incubation station where it is held for a period of time sufficient for the chemical reaction to have culminated, and then passed to an optical reading station, for example one similar to that shown in fig. 5-

A fully automatic analysis system in which the elastic container shown in fig. 6 is used, is shown in fig. 7 in which a storage magazine 102 for prepackaged reagents is divided into a number of compartmentalized compartments 103, 104, 105, 106, etc. Each elastic container is stored on a data card 101, a prepackaged chemical examination unit. Only similar units are stored in the same compartment with other elastic containers. A transport device in the form of a transverse card handling device 107, which moves back and forth on runners 108

and 109, are located next to the opening in the magazine 102 in order, in accordance with a given input signal from a control panel 110, to select the correct data card 101 for carrying out a desired analysis. Associated samples are placed in a sample magazine 118 where each sample has its own special identification. As shown, disposable syringes 113 are carried by a rotating syringe head 114

which moves in a counter-clockwise direction. An unused injection syringe is first taken to a diluent reservoir 117 where the exact amount of diluent, normally distilled water, is drawn up into the syringe. By turning in a counter-clockwise direction, the syringe containing the diluent is led to the magazine 118 where a small amount of sample, accurately measured, is drawn up into the syringe from a sample container 119 - At the same time, a machine-readable number is read on the sample container and transferred to the control panel 110 The control panel compares this number with other data previously stored in the panel and determines the exact examination to be carried out on the sample. The transverse card handling device 107 is moved to a position close to the correct, compartmentalized space in layers

the ring magazine 102 for prepackaged reagents and picks out a data card 101 which has the corresponding container 100 for carrying out the desired analysis. The card handling device is then moved to a position near the opening 111 in the sample addition station 112. The data card is moved into the sample addition station 112 where the disposable syringe 113 after having turned l80° on its head from station 118 is placed over the elastic container on the card. The syringe 113 is lowered by means of a gear device 120 until the needle penetrates the elastic container 100 and the diluted sample has thus been placed in the container. The sample material is injected into the elastic container either before, during or after the appropriate reagents have been emptied from their storage areas into the lower compartment. If desired, mechanical parts or fingers can be arranged in the sample addition station, which can be programmed to sequentially empty the contents of the reagent chambers into the bottom of the elastic container. If desired, the diluted sample can be injected into the elastic container and then diluted with distilled water from a separate injection source (not shown). At this point, the blind test reading can be carried out by the detection unit if desired. Unused injection syringes are stored in a syringe storage area 115 and are released by a syringe dispenser 116 into open spaces in the rotating syringe head 114 as these become free after removal of used syringes. It is preferred that a disposable syringe is used for each sample material Thus, if several examinations are to be carried out on a particular sample, it will only be necessary to discard the syringe after the completion of the transfer of the total number of sample parts. However, if the syringe is carefully cleaned and precautions are taken to avoid transfer contamination, each syringe is used as long as desired. The card 101 is then passed from the sample addition station 112 to another transverse card handling device 121 which moves back and forth on runners 122 and 123. The transverse card handling device places the card in the far inlet of an incubation station 125. Pre-registered data on the data card determines when the card is due let the incubator and consequently the elastic container is kept in the incubation station for a period of time sufficient for the chemical reaction to culminate. At this point, the card is ejected from the incubation station 125 and picked up by the transverse card handling device 121. For increased flexibility, a further transverse card handling device can

(not shown) are arranged, exclusively for removing the data cards from the incubation station and introducing these into the detection station. If additional addition of reagents is required after the first incubation cycle, the data cards are taken by the transverse card handling device to a reagent addition station (which may be station 112 or a separate station) for addition of additional reagents. The data card can then be placed back in the incubation station 125 or sent directly to the detection station. Where the rate of chemical reaction is of the important data to be obtained, such investigations can be adapted by periodically bringing the disposable container from the incubator and then repeating these steps until a sufficient number of readings have been taken. The data thus obtained can then be correlated and produced as a curve which defines the rate at which the chemical reaction in the separated reaction chamber progresses. For certain reactions, this speed is proportional to the concentration of the component to be analysed. From the card handling device 121, the data card is fed into a slot 126 which defines the detection station in which one or more physical properties of the reaction mixture are determined in order to obtain the desired analytical data. In the display station, the obtained analytical data is immediately transferred to the data card to provide a complete record for later use. After examination, the card is ejected from the display station 126 at an opening 127 and picked up by a transverse card handling device. Once again, for increased flexibility, a transverse card handling device may be provided only to pick up ejected cards from the detection station. The data card is then taken to a station 128 where a cutting device 129 removes the part of the card that carries the elastic container.

The part of the card that carries the elastic container falls into

a waste room 130, while the data-containing part of the card is dropped into a storage container 131- As shown, the storage container 131 is not integrated with the control unit 110, but can easily be placed to be part of it. If it is placed like this, the cards can be automatically read and the data stored in an associated memory device for later reference. In the device described, the cards are taken by a technician and transferred to the control unit where the information on the card is stored until the time when it is needed by the doctor.

After the first card for a given assay has been placed in the sample addition station 112, the transverse card handling device 107 will immediately move to the appropriate compartment adjacent to the magazine to receive another card, and the entire process is repeated for that particular assay. It will be understood that there will be many cards in different places in the system at the same time. By simultaneous, it is not meant that the beginning and end of each analysis coincide with the beginning and end of other analyses, but rather that there is a significant overlap in the operational steps involved. Thus, one card will be in the sample addition station while another will be in the detection station.

It is clear that the analysis of the sample in the card in the detection station will be completed long before the completion of the sample that has now been supplied. However, since there is an overlap of operational steps, such tests are considered to be simultaneous in the sense of the word used in this application.

In fig. 8 shows an alternative embodiment of the present invention, in which the supporting base for the elastic container comprises an elongated band 140 on which several elastic containers 141 are stored. The container-carrying tape is wound up on a storage reel 142 and is passed through a sample addition station 143, a mixing and incubation station 144, an optical reading station 145 and is finally placed in a waste station (not shown) or wound up on a receiving reel (also not shown). The tape l4C has perforations and associated guide wheels, like live film, so that they can be indexed from position to position. The carrier tape may have magnetic coding along the edge or other means for printing in two languages. Sensors mounted along the edge of the belt can read the recorded data and direct different parts of the system to perform the desired operations on the elastic container. Data, such as patient identification numbers and analysis results, can be recorded on the tape for storage and later reading. A locking mechanism 146 is arranged to move a test syringe 147 and detection device in and out of position.

As will be clear, the device does not have that flexibility

as more fully automated systems, such as that shown in fig. 7. Each particular sample must wait its turn for analysis, and only one type of examination or a fixed series of samples is normally programmed in a reel (including the total apparatus). For more flexible multi-purpose examinations, a stock of reels has been arranged,

as each reel has a different ready-made package of test tubes for analysis, so that several different examinations can be carried out

taken simultaneously (1) on parts of the same sample, or (2) on different injected samples. In this case the coils are mounted close to each other and the test syringe moves back and forth across the coils.

A further example of a disposable container is shown in figures 9 and 10 where a supporting part 150 is provided on one side with an elastic container 151 divided into a compartment, reaction chamber 152 and number of reagent supply chambers 153 and 154. A strong seal 155 is arranged along the unit's outer circumference for secure attachment of the container to the substrate. Weak seals 156 and 157 separate chambers 152 and 153, respectively chambers 152 and 154, which seals can be opened using heat, vacuum, bending or pressure to provide a single compartment in which the powdered reagents are loosely mixed at the bottom. A channel 158 is arranged for the introduction of diluted sample material into the chamber 152. After the addition of the sample, it should be ensured during the mixing operation that no part of the reaction mixture in the chamber 152 is accidentally emptied out of the room. This can be achieved, for example, by heat sealing a portion of the channel 158 to the substrate 150 (as shown by dotted lines 160) or by simply keeping the channel closed mechanically. Powdered reagents 161 and 162 are stored in chambers 153 and 154. As shown, additional reagents 163 may be stored in main chamber 152.

If additional reagent storage chambers are required for storage of all reagents, such chambers can be arranged in communication with chamber 152. As will be seen from fig. 9, each chamber 153 and 154 is divided along the dotted lines as shown in the chambers into two separate storage areas. The dotted line separating the two storage areas may represent a strong seal if the reagents are to be emptied first into the main chamber 152, or alternatively it may be a weak seal if the reagents, in the different areas in the same chamber, are to be mixed together before being added to the main chamber 152. In the latter case, the weak seal 156 should be reinforced by external forces, such as metal fingers or

-rolls, while the weak seal along the dotted line is broken and the materials in the respective storage areas are mechanically mixed. The seal 156 is then broken, and the mixed reagents are emptied into the chamber 152. As previously mentioned, it is possible to add reagents

the genes in order from the different storage chambers to fixed-satté times during the analysis process. If necessary, a diluent may be added to either of the storage chambers 153 or 154 prior to the time the reagent is emptied into the chamber 152 to dissolve the reagents stored therein. The described disposable container in this figure can be connected to a data card and, for example, passed through a system as shown in fig. 7, or is made part of an analysis tape as used in the system shown in fig. 8.

As previously mentioned, the weak seals that separate the storage chamber from the cuvette compartment can be broken by heat, vacuum, bending or pressure. During the application of heat, the sealant must be bent away from the substrate to which it is bonded. A further heating technique is the use of a fusible material, for example paraffin, which has been used as a binder to bind the two layers together. During the application of heat, the binding properties of the fusible material are destroyed so that the layers are separated. Using vacuum techniques, the device can be placed in a mold and subjected to sufficient vacuum to lift the upper layer from the supporting layer to thereby break the weak seal and place the chambers in communication with the reaction chamber. The weak seals can also be broken by mechanical handling. Furthermore, buttons or weight bars etc. can be arranged which can be grasped by mechanical elements and moved, pulled or in some other way. maneuvered until the seal is broken. In each of these cases, the destruction of the weak seals can be carried out in different periods of time in order to successively empty the contents of the chambers into the reaction chamber. This further contributes to making the analysis process flexible.

As it can be expected that the disposable containers will be stored for a longer time and with the prepackaged reagents contained therein, the disposable container materials are chosen so that they do not damage or contribute to the degradation of the prepackaged chemicals. It is preferred that the construction materials are chemically inert, or at least chemically inert to the reagents and any chemicals that in a clinical environment could come into contact with the container. When the reagents are prepackaged, the outer layer of the compartmentalized storage chamber will serve as a barrier material that prevents the passage of contaminating factors. Alternatively, a number of disposable containers which do not have particularly good long-term barrier properties can be packed together in a barrier material which will preserve the original properties of the prepackaged reagents. Suitable materials include carbon fluorides such as trifluoromonochloroethylene, polytetrafluoroethylene and "Fluorothene" and polyolefins such as polyethylene, "Ionomer" (a polyethylene polymer) and polypropylene, polystyrene, polyvinyl chloride, polyethylene terephthalate and polycarbonates. During use, the reaction mixture will be in the cuvette for a relatively short time compared to the total storage time of the prepackaged unit. It is therefore not necessary to set the same strict requirements for the material that makes up the separated cuvette compartment as for the reagent storage section. The cuvette material is preferably inert to the reaction mixture under the conditions that exist during the analysis. The material should also not be porous in order to prevent seepage of the reaction mixture from the reaction chamber. Optically, the material should be able to transmit a significant part of the light

who falls on it. It is preferred that the material is clear throughout, but a material that is uniformly matt can also be used. The walls of the cuvette are elastic and yield under the application of a force in the detection station to delineate a fixed optical path between the light source and the detection device. As the cuvette is elastic, it is possible to eliminate production requirements such as exact width or diameter in the cuvette, as would be the case if the cuvette was made from a rigid material. With an elastic cuvette, quality is more important than accuracy. Suitable materials include plasticized polyvinyl chloride, "Ionomer", cellulose acetate, cellulose propionate and cellulose butyrate. It is not always possible to provide a material that has all the necessary properties for storage as well as for good optical properties. Consequently, the reagents can be stored in a compartment built from one material, while the cuvette can be made from another material. The two departments can then be combined in any suitable way to produce a prepackaged unit. It should also be noted that two or more layers can be laminated together to produce a storage chamber having the desired barrier properties. Examples of materials used in the manufacture of disposable containers as described in connection with Figures 1-5 include polyolefins for the reagent storage section and the restraining layer that holds the reagents in the "floss hat" chambers, and cellulose propionate as the cuvette. As mentioned, the restraining layer can be made of the same material as used in the manufacture of the reagent storage sections. To achieve proper ice shredding, materials in the restraining layer should be somewhat thinner than the material in the storage section.

The method of manufacturing the disposable containers does not form any part of the invention. In general, however, any method can be used for the production of containers that have the desired properties. Heat forming operations such as pressure forming or vacuum forming can be used to produce parts of the disposable container that have an intricate design. Pressure forming is preferred, however, because it is possible to use high-pressure air to force the plastic material into areas where it cannot be drawn by a vacuum. Heat forming operations are particularly applicable in the production of elastic parts of the container where the walls are relatively thin.

The reagents stored in the chambers of the disposable container can be either in solid or liquid form. However, liquid storage is not so desirable because there is a greater tendency for chemical reaction, either with the storage wall or with material that penetrates it. Liquid materials are also generally known to be more sensitive to light and other parts of the electromagnetic spectrum and will therefore deteriorate faster if suitable filters are not arranged to eliminate harmful radiation. Consequently, it is preferred to store the reagents in solid form if this is possible. Stored in solid form, the reagents can be in powder form or in the form of tablets, either alone or in combination with other compatible reagents. A disadvantage of storing two or more powdered reagents together is the very large surface area that becomes available for chemical reaction. Although the materials are relatively non-reactive, prolonged storage under such conditions may have a detrimental effect on the reagent mixture. In such cases, it would be best to pack the materials separately or to pack them in tablet form. Tableting sufficiently reduces the contact surface area to only point contact, as is essentially achieved when one spherical (or nearly spherical) tablet is placed on top of another. The actual shape of the tablet is not critical, but choosing the right shape (for example to provide mini-template contact) can prove advantageous for increasing the storage time of the prepackaged reagents. By also arranging blocking devices

in the storage chamber and slide the tablets into place, several tablets can be placed in the same chamber, but separated from each other to eliminate contact which enables chemical reaction. If sufficiently strong locking devices are arranged, it becomes possible in this case to omit the retention layer in Figures 1-5 or the weak seal

ing in fig. 6 in the analytical processes in which all the reagent tablets are dropped into the reaction chamber before mixing, or it is not unfortunate that the reaction mixture splashes onto a tablet that is still

has not been released into the mixture. Tableting provides a feasible method for accurately placing the correct amount of chemical reagent in a special chamber. Serious dust and pre-contamination problems can occur when several different powdery chemicals are placed in the storage chambers that are separated by only a few millimeters from each other. When the addition takes place in the form of

tablets, at least these problems are eliminated from the packaging process and placed in their own area where they can be taken care of individually. It is naturally necessary to use only such materials in the tableting process as will not have any detrimental effect on the analytical process. In all cases, the reagents, whether they are stored in liquid or dry form, must be added to the reagent chambers in measured quantities whose tolerance is determined by the given analytical process. Finally, storage of the reagents, whether they are in the form of powder, tablets or liquid, can take place in an inert gas atmosphere, such as nitrogen. By providing an inert atmosphere, the relative chemical activity of the reagents is noticeably reduced and the durability of the prepackaged unit is increased.

Although the invention has been described with reference to preferred embodiments thereof, it will be understood by those skilled in the art that various changes in the form of details can be made without deviating from the framework of the invention. Many alternative container designs are conceivable, which will give the advantageous results described here. While one embodiment is shown for securing the upper section in fig. 1-5 from the lower section, many other ways can be used to achieve this result. For example, the upper section can be heat-sealed to the lower section or the sections can be shrunk together to produce a unitary structure.

Furthermore, it can be expected that any analytical process can be applied to the invention described herein. While the described apparatus and system is particularly suitable for routine blood tests, for example for glucose, blood urea nitrogen, albumin, bilirubin, total protein, etc., numerous other analyzes performed periodically in any chemical area can be performed automatically according to the description above.

Claims (1)

Disposable container for carrying out a chemical analysis reaction as specified in patent no. 127-127, comprising at least a lower part with a reaction chamber (51,52) for mixing materials introduced therein and for producing a chemical reaction between them, an upper part ( 61) with storage chambers (63,93,94) for separate storage of reagent (68,96,97), which storage chambers are arranged to be connected to the reaction chamber (51,52) in the lower part, which is closed to the outside with the exception of its connection with the storehouses, as well as a blocking device (64) arranged to prevent premature transfer of reagent (68,96,97) from the storage chambers to the reaction chamber, characterized in that the reaction chamber (51,52) has two parallel side walls (54,56) which are perpendicular to the bottom of the chamber (53), the side walls (54,56) being elastic and translucent so that an optical analysis of the contents of the chamber can be carried out.