JP3474558B2 - Improved microcontainer for clinical analysis - Google Patents

Description

Detailed Description of the Invention

The present invention proposes an improvement of the microcontainer, especially for clinical analysis of blood groups, which brings new and inventive features to the functions required of the microcontainer.

[0002] In particular, an improvement to which the present invention pertains relates to a microcontainer for clinical analysis which comprises a lower body carrying a reagent, optionally incorporating a gel for retention and filtration. The modified micro-container receives the sample to be analyzed at the upper opening of the container, and the sample, after exerting an appropriate centrifugal force, advances to the reagents contained in the lower body.
In a preferred variant, the microcontainers form a unit in the form of a "plate" or a "card", which makes them easy to handle.

Microcontainers for performing clinical analysis are already well known in the market. Thus, for example, EP 194212 discloses a microcontainer in which the upper part is cylindrical and the lower part is tapered after the middle conical region. EP-A-305337 further discloses a similar micro-container, optionally with flattened sides, mounted on a flat plate. All of the above mentioned micro-containers open in the upper part when used for a specific purpose. In the case of blood analysis, all of these are erythrocytes that are placed on a mixture of particles or gels and absorbed by aggregated serum, and are permeated into the layer of the reference formed by the reagent and particles by applying a centrifugal force. However, it is based on the fact that red blood cells agglutinate as they react, if the reacting serum and red blood cells are of the same type. If the agglomeration is complete, a large-sized clot will not form and will not be able to penetrate the granular mass, and will be visible as is on the layer of particles or gel. In the absence of reaction, erythrocytes do not aggregate and pass through a layer of gel and particles to the bottom of the tube with a size smaller than a clot.

However, known microcontainers of this type have some disadvantages due to lack of effective retention due to the uncertain position of the reagents in the cylindrical lower part of the microcontainer. Therefore, when a card of this type of micro container is put to practical use, the card or the like often drops due to an erroneous operation, and a part or all of the reagent is discharged from the cylindrical main body of the micro container. As a result, the container cannot maintain the proper state for performing the analytical sample receiving function, resulting in inaccurate results and causing a serious situation.

Another disadvantage with some of the presently known analytical microcontainers is that the introduction of the analytical sample may take place too fast, ie without proper pipetting. This does not guarantee the next smooth normal entry of the analytical sample by exerting a centrifugal force, lifting the mixture at the wrong time. This again leads to incorrect interpretation.

The microcontainers known today are therefore prone to incorrect analytical results. This will have markedly serious consequences. Especially in the case of blood analysis, incorrect results may lead to life-threatening situations for patients, as evidenced by recent clinical cases.

In order to overcome the above disadvantages, the applicant of the present invention has timely filed a Spanish Utility Model Application No. 9900372. The proposal provides a controlled closure element arranged between the upper part of the microcontainer, ie the receiving cavity and its lower part, so that the closure element interposed between the two chambers has a reduced cross section. To leave freely,
It was essential that the communication between the upper part and the lower part occurred by the action of centrifugal force. The reduced cross-section was sufficient for passage by the action of centrifugal forces, but impeded free passage from the upper chamber to the lower chamber of the microcontainer, as was found in practice. The invention has already made significant progress in that an intermediate suppressor is arranged between the upper opening of the microcontainer and the lower body containing the reagent, and an abrupt entry of an analytical sample into the body containing the reagent. I was prevented from letting me.

The present invention constitutes an improved version of the '372 application by the applicant. The present invention, which was constructed by providing a body for controlled closure between the upper opening and the lower body of the microcontainer, had a definite practical effect. Thus, if the pipette carrying the analytical sample is introduced with excessive force and / or to an excessive depth due to improper handling by an inexperienced operator, its action can still cause partial lifting of the intermediate obturator It turned out that there is a nature. This will allow accidental passage of the pipette towards the lower portion of the microcontainer. No reaction is therefore seen, giving an increase in total false readings, which is particularly dangerous in the case of blood analysis.

The object of the present invention is therefore not only to have sufficient features to protect against abrupt entry, ie against misalignment of the analytical sample, but at the same time avoiding a loss of efficiency in the intermediate suppressor. , To provide a micro-container for clinical analysis that prevents its release.

To this end, the present invention provides an intermediate body for the controlled separation between the inlet of the microcontainer and the lower body containing the reagent, of special construction for receiving the intermediate body. We propose a micro container for clinical analysis that is held by a seat. This configuration allows the analytical sample from the introduction opening to pass through a narrow gap controlled by the intermediate body toward the lower body containing the reagent by applying a centrifugal force, and further, the intermediate body. To prevent it from leaving its seat, ensuring the desired efficiency.

The intermediate body is preferably adapted to be held in place by arranging longitudinal ribs in the seat area. Longitudinal ribs define a limited body support area to prevent inadvertent removal of the intermediate body from its seat, while at the same time allowing passage of the sample towards the lower body of the microcontainer in which the reagent is placed. To define

In summary, the invention is characterized by the provision of means for axially holding the restraint in its seat, the holding means being the machine of the restrainer and its seat area in the middle constriction of the microcontainer. It is composed of the target closing margin. Further, the holding means spreads in a limited area around the suppressor, and the sample from the opening is allowed to enter the micro container by a centrifugal force and leave a free passage toward the main body carrying the reagent. The interference can be achieved, for example, by forming a housing at the leading edge of a longitudinal rib arranged at the narrowed portion of the micro container. The shape of the housing conforms to the lateral surface of the restraint and allows the introduction by the elastic energy of the microcontainers and / or the restraint. According to yet another example, the interference can be achieved by forming a multi-faced housing that accommodates an aspherical suppressor or the like in the narrowed portion of the micro container.

The drawings showing the preferred embodiments of the present invention are as follows:
It is not for the purpose of giving a restrictive example, but for better understanding.

As will be appreciated from the drawings, the present improvement applies to a microcontainer having an opening or upper body 1 and a lower body 2 for containing a reagent. These two are separated by a constriction region 3 in which an intermediate body 4 is arranged. The intermediate body 4 acts as a restraint device to prevent the sample from entering at high speed, i.e. the misplaced dropping pipette or nozzle resulting in direct mixing with the reagents of the container 2. This improvement provides a means for axially retaining the restrainer 4 in its housing. This is achieved by a variety of configurations using the natural elasticity of the micro-containers and the suppressor 4, which is usually a small sphere, which the suppressor 4 allows for the introduction of balls into the elasticity of the suppressor material. It overcomes the slight collision with the micro-container and is introduced into its restraining position. Preventing the restraint from disengaging from the seat is the elastic energy of the material in combination with the specially shaped seat for restrainer 4. In the opening region 3, the numbers 5, 6 and
There are several longitudinal thin walls or ribs designated 7,8. The number of ribs can be changed. Further, the rib has a straight edge at its leading edge and is provided with a recess 20 having a shape matching with the suppressing body 4, that is, if the suppressing body is a spherical ball as shown in the drawing, it has a curved shape. It is also characterized in that it can have.

In the variant of the invention shown in FIGS. 4 to 6, the opening 9 of the microcontainer comprises a constriction 10.
The narrowed portion 10 is a multi-sided lateral shape for accommodating the suppressor,
For example, a quadrangular multifaceted with sides 11, 12, 13, 14 and edges defining respective passages 16, 17, 18, 19 that communicate the openings in the upper region with the lower body of the microcontainer. It can have a horizontal shape. The suppressor is preferably in the shape of a ball 15 that can be held under pressure inside the multi-sided housing.

The restraint can be retained inside the multi-faced housing by the simple elastic energy of both the restrainer and the container, or by creating a conformally shaped region for accommodating the restraint when it is introduced. . Needless to say, this holding shape is also applicable to the structure shown in FIGS. [Brief description of drawings]

FIG. 1 is a longitudinal cross-section of an upright surface of a microcontainer including the improvement of the present invention.

FIG. 2 is a longitudinal cross-sectional view of an upright surface of a microcontainer including the improvement of the present invention.

FIG. 3 is a plan view of a micro container.

4 is a cross-sectional view similar to FIG. 1 of a modified embodiment of the present invention.

5 is a sectional view similar to FIG. 2 of a modified embodiment of the present invention.

6 is a plan view of the micro-container shown in FIGS. 4 and 5. FIG.

[Explanation of symbols]

1, 9 Opening (upper body) 2 Lower body 3, 10 Constriction area 4 Intermediate body (suppressor) 5, 6, 7, 8 Longitudinal wall 11, 12, 13, 14 Polyhedron side 15 balls 16, 17, 18, 19 passages 20 recess

Claims (4)

(57) [Claims] 1. A centrifugal force acts on a controlled gap for passage of an analytical sample toward a reagent-carrying main body, comprising an upper opening and a cylindrical lower container carrying a reagent. In an improved micro-container for clinical analysis of the type having an intermediate restrainer defined by a means for axially retaining the restrainer in its seat, the restrainer at an intermediate stenosis of the micro-container. And the seating area of it and the mechanical interference between them, further extending to the restricted area around the suppressor, allowing free passage of the sample from the opening to the micro-container and to the reagent-carrying body. The improved microphone is provided with a holding means for leaving the gap between the two by applying a centrifugal force to prevent the intermediate restraining body from being accidentally lifted from the seat. Container. 2. The improved micro-container for clinical analysis according to claim 1, wherein the mechanical interference between the restraining body of the micro-container and the seat of the micro-container is the longitudinal direction arranged in the narrowed portion of the micro-container. Achieved by forming a housing at the leading edges of the ribs of the housing, the housing having a shape that matches the lateral surface of the restrainer to allow the resilience of the microcontainer and / or restrainer to introduce the restrainer. An improved microcontainer characterized by 3. The improved microcontainer for clinical analysis according to claim 2, wherein the longitudinal thin wall comprises a curved housing at its leading edge to accommodate a ball-shaped restrainer. A featured improved micro-container. 4. The improved micro-container for clinical analysis according to claim 1, wherein a narrow face of the micro-container is formed with a multi-faced housing for accommodating a sphere restrainer or the like by a tightening margin. An improved micro container.