JP4474311B2 - Saliva collection device and saliva collection device - Google Patents

Description

  The present invention relates to a saliva collection device and apparatus in the fields of biochemical tests and medical examinations using saliva.

Saliva contains many marker components that reflect infectious diseases such as AIDS, stress state, cellular waste, occult blood, digestion, and female hormones, and these are greatly related to human epidemics and health conditions. Yes. A health condition can be diagnosed by detecting the absolute amounts of these components and their degree of change.
In the field of biochemical tests and medical examinations, there are many options such as blood, saliva, urine, etc., but among them, saliva has the least physical and mental pain at the time of collection, Moreover, it has a certain degree of correlation with the dynamics in blood.
In the background as described above, the market for saliva testing is an area that can be expected to expand in the future, and normal testing technology seeds are almost established. In the examination of saliva, diluted saliva is generally used. Examples of saliva collection techniques applied to these tests include those shown in Patent Documents 1 to 3, and are roughly classified into the following various methods.

(A) First, as a first method, there is a fiber sampling method. This method is
1) Have the subject bite the fiber, soak the saliva into the fiber,
2) Collect saliva from the fiber and transfer it to the recovered solution.
3) Weigh a specified amount with a measuring instrument such as a pipette and weigh it into a container such as a test tube.
4) The procedure is carried out in such a manner that a fixed amount of diluent is added thereto, and the mixture is stirred and mixed with a vibrator to dilute. Of the above procedure, all operations after 2) are performed by specialized technicians using dedicated instruments and devices.
(B) As a 2nd method, there exists a system which exhales saliva directly to a collection container. This method is
1) Have the subject exhale saliva directly into the collection container,
2) The saliva in the container is carried out in the same procedure as (a) 3) to 4) above. The same goes for the necessity of professional technicians, specialized equipment and equipment.

(C) As a third method, there is a method using a saliva collection kit. This method is
1) Ask the subject to collect his saliva using the simple collection tool in the kit,
2) Have it transported to the designated inspection organization,
3) The procedure is carried out in the same manner as (a) 3) to 4) in the inspection organization. The same goes for the necessity of professional technicians, specialized equipment and equipment.
(D) As a fourth method, there is a method using a saliva test kit. This method is
1) Ask the subject to collect his saliva using the simple collection tool in the kit,
2) Have the subject conduct a simple test using the simple test tool in the kit.
It is carried out by the procedure. Some kits do not require specialized technicians or specialized equipment and equipment.

JP 2000-009728 A JP 2002-181812 A JP 2003-014733 A

  However, in each of the first to third saliva collection methods in the above-described conventional technique, a specialized engineer is required, so that the cost is increased. In addition, in the third method, since the transportation period is involved, even if the diluted saliva is examined, a value different from the biochemical index in the collected state is obtained due to decreased salivary activity, deterioration, degeneration, etc. As a result, it took a long time of one to two weeks for the subject to obtain the test results. Furthermore, in order for the action at the time of collection to be performed in a certain scene, giving the subject a sense of resistance has also been a limitation.

Although the fourth saliva collection method is relatively low cost, the work to be performed by the subject is complicated, and therefore the burden on the subject is large. In addition, it is inevitable that the work proficiency level of the subject may affect the inspection accuracy.
The present invention has been made to solve the above problems, and an object thereof is to provide a saliva collection device and a saliva collection device that are simple, quick, and low-cost. Furthermore, in the future, the aim is to make it possible to construct a simple, rapid, and low-cost saliva automatic testing system incorporating this saliva testing device.

In order to solve such a problem, the invention of claim 1 incorporates a saliva injection port for directly injecting saliva into a subject's mouth, a saliva chamber for stocking saliva, and a predetermined amount of diluent. Disposed in the middle of the dilution chamber, a first conduit connecting the saliva inlet and the saliva chamber, a second conduit connecting the saliva chamber and the dilution chamber, and the first conduit A check valve ,
The internal volume of the saliva chamber is changed by external pressurization to the saliva chamber, and the saliva is measured and transported to the dilution chamber based on the change, and the check valve is used to transfer the saliva to the saliva inlet side. It is characterized in that the backflow is prevented and the saliva and the diluting liquid are mixed with each other by external vibration so that the saliva can be rapidly diluted.

According to the first aspect of the invention, the following advantages can be obtained.
Saliva collection, weighing, and dilution can be completed within a single instrument. Therefore, a series of steps from collection to dilution can be performed continuously and automatically, and the required time can be shortened. In addition, since a series of steps is completed in the same instrument, foreign matters can be prevented from being mixed in from the outside during the steps. Therefore, it is not necessary to consider the cleanliness of the usage environment. In addition, since only one instrument is used, the amount of waste can be easily suppressed even in the case of disposable. Further, even if the instrument Ru recycling Angeles, the amount of the washing waste water collection container, compared with a case requiring metering instrument-dilution container, requires only much less. Therefore, in both cases of disposable and recycling, reduction of the environmental load can be expected. Furthermore, since the movement of the collection can be done by placing the instrument directly on the mouth and blowing it into the instrument, the actions are similar to playing a wind instrument or inflating a balloon. Can be relaxed. Moreover, since there is no worry that saliva touches human eyes, it can be used without worrying about human eyes. In addition, since the check valve is arranged in the middle of the first pipe line, the backflow of the saliva in the saliva chamber to the saliva inlet side can be prevented. That is, there is no need to worry about saliva leaking between the time when the subject collects saliva and the time when the subject inserts into the saliva dilution device. Further, when the saliva chamber is pressurized after being inserted into the saliva dilution apparatus, saliva corresponding to the volume change due to the pressurization can be transported to the dilution chamber side without backflow.

In the invention described in claim 1, also arranged a check valve in the middle of the second conduit, it is possible to prevent backflow into the saliva chamber side of the liquid dilution chamber (the invention of claim 2) . According to the present invention, it is possible to prevent the diluting solution built in the diluting chamber from flowing backward to the saliva chamber side. Further, when the dilution chamber is vibrated after the saliva is transported into the dilution chamber, backflow can be prevented even if there is an impact due to the vibration.

In the first or second aspect of the invention, a material having flexibility, biocompatibility, and safety is used as a member of a contact portion that is directly applied to the mouth of the subject in the saliva injection port. (Invention of claim 3 ). According to the present invention, it is possible to prevent the mouth of the subject from being hurt when saliva is collected.
In the invention of any one of the first to third aspects, a taper is imparted to the outer shape in the vicinity of the contact portion so that the shape can be adapted to the size from the child to the adult's mouth. Invention). According to the present invention, it is possible to fit (fit) mouths of various sizes from children to adults.

In invention of Claim 5 , the saliva collection instrument insertion port for inserting the saliva collection instrument in any one of Claims 1-4 , the fixed slider which guides an insertion path, and the saliva chamber of the inserted saliva collection instrument A cam mechanism for conveying while being pressurized, and a stopper for fixing while positioning the conveyed saliva collection device, and further, having a function of applying vibration to the saliva collection device, of the inserted saliva collection device Inside, the saliva can be measured and transported automatically and quickly, mixed with the diluent, and diluted. According to the present invention, just by inserting the saliva collection device according to any one of claims 1 to 4 , the saliva is automatically and rapidly measured and transported inside the saliva collection device, and mixed with the diluent. Can be diluted.

According to this invention, saliva collection can be performed easily, quickly, and at low cost. Furthermore, in the future, if a saliva automatic inspection system incorporating this saliva collection device is constructed, it can be expected that the processes from saliva collection to detection will be automated and completed quickly. If it does in this way, it will also become possible for a subject to obtain a test result on the spot only by installing a saliva collection instrument in a saliva automatic inspection system machine.
In that case, it is predicted that the feature of not limiting the use place of the saliva collection device of the present invention as described above is an important point. That is, since it is not necessary to consider the subject's sense of resistance and mixing of foreign matter from the outside, a very wide choice can be obtained as the installation location of the inspection system machine. Therefore, it can be expected that market expansion is easy to realize.

FIG. 1 is a configuration diagram showing an embodiment of the present invention, and shows a configuration of a saliva collecting device.
The main configuration of this instrument is a saliva injection port 1 that directly applies to the subject's mouth and blows saliva, a saliva chamber 6 that stores (stores) saliva, and a dilution chamber that contains a predetermined amount of diluent 8 7, conduits 4 a and 4 b connecting the saliva inlet 1 and the saliva chamber 6, and conduits 4 c and 4 d connecting the saliva chamber 6 and the dilution chamber 7.
When pressure is applied to the saliva chamber 6 by an external cam mechanism (not shown), the internal volume of the saliva chamber is changed, and saliva is transported to the dilution chamber 7 while being directly or indirectly measured based on the change. The Furthermore, the saliva can be rapidly diluted by mixing the saliva and the diluent 8 inside the dilution chamber 7 by an external vibration function (not shown).

In addition, a check valve 5 a is disposed between the pipe lines 4 a and 4 b to prevent the saliva in the saliva chamber 6 from flowing back toward the saliva inlet 1. Similarly, a check valve 5 b is arranged between the pipe lines 4 c and 4 d, and prevents the liquid in the dilution chamber 7 from flowing backward toward the saliva chamber 6.
On the other hand, it is desirable to use a material having flexibility, biocompatibility, and safety as the member of the contact portion 2 that is directly applied to the subject's mouth. For example, contact lens materials have already been proven in terms of flexibility, biocompatibility, and safety, so diversion is expected. As other candidates, a containing gel CL (SCL), an ionic water-containing gel, a polyvinyl alcohol (PVA) -based material, and the like are assumed.

In addition, the outer shape of the close contact portion 3 is tapered so that it fits the size of the mouth from children to adults. Specifically, it is assumed that the inflating portion of the swimming float is simulated. By imitating not only the structure but also the material, it is possible to reduce the cost while satisfying the flexibility, biocompatibility and safety described above.
Further, an upper surface recess 10 is formed in a part of the upper surface 9 of the instrument, and has a structure that matches the shape of a cam mechanism (not shown). Moreover, the lower surface part level | step difference 12 is formed in a part of the instrument lower surface 11, and has played the auxiliary | assistant role when a cam mechanism act | operates. The instrument side surface 14 has a shape that fits a human (human) finger so that the subject can easily hold it. The structure is such that a finger goes through. This prevents accidental pressurization of the upper surface recess.

FIG. 2 is an embodiment showing the configuration of the saliva collection device according to the present invention. This is an apparatus for automatically diluting saliva by inserting the saliva collecting device 15 shown in FIG.
That is, it comprises an insertion port 16 for inserting a saliva collection device, a fixed slider 17 for guiding an insertion path, a cam mechanism 18, a stopper 19, and a vibration function (not shown).
The subject inserts the saliva dilution device 15 into the saliva collection device insertion port 16 first from the device back surface 13. After the insertion, the insertion path is automatically guided by the fixed slider 17, and the saliva chamber 6 is conveyed while being pressurized by the cam mechanism 18, and the conveyed saliva dilution device 15 is positioned and fixed by the stopper 19. To do. Subsequently, a vibration function (not shown) is automatically activated for the saliva collecting device 15. Thereby, the subject can complete the dilution of saliva automatically and quickly only by inserting the saliva collecting device 15.
As for the cam mechanism, the pushing force of the subject may be used without providing the cam mechanism when it is finally put on the market as a device. According to this, since the structure of the apparatus can be simplified, cost reduction can be expected.

  FIG. 3 is an embodiment showing an automatic saliva inspection system machine incorporating FIGS. 1 and 2 of the present invention. This system machine has a built-in detection function in addition to the saliva dilution function, and is a device that can automatically perform from the dilution to detection of saliva. At the present time, a technology that can reduce the function of automatic saliva detection has not been established, but it is assumed that this technology will be applied to salmon that will be established in the future.

  FIG. 4 is a system configuration diagram of FIG. 3, in which each element function of this system is arranged. A range surrounded by a single line indicates a function built in the saliva automatic inspection system 29. Within this range, a range surrounded by a double line is the saliva dilution function unit 30 and corresponds to the functions of FIGS. 1 and 2 of the present invention. The function of automatic saliva detection described above is arranged outside the range of this double line. Thus, although the dilution and detection of saliva are distinct in function, as an internal structure of an actual system machine, the dilution and detection functions can be integrated in the same apparatus. The saliva dilution / detection unit 24 shown in FIG. 3 is a specific example of the integration.

The procedure for the subject to actually use the system will be described with reference to FIG.
Now, when the subject 31 operates on the operation panel 21, the saliva collection device 15 comes out from the saliva collection device outlet 26. When the subject 31 collects saliva in the saliva collection device 15 and then inserts it from the saliva collection device insertion port 23, the work to be performed by the subject is completed. The following is an automatic operation within the system unit.
First, under the control of the control unit 22, the saliva dilution / detection unit 24 automatically dilutes / detects saliva, and the result is displayed on the operation panel. Thereby, the subject can also obtain a test result after several minutes on the spot where the saliva is collected.

  With regard to maintenance, the device after completion of detection is conveyed to the collection unit 27. Subsequently, the reagent supply path in the apparatus is cleaned by the cleaning unit, and the cleaning wastewater is transported to the waste liquid unit 28. A plurality of unused saliva collection devices 15 are stored and replenished by regular maintenance. The same applies to the replenishment of reagents used for detection. The collection unit and waste liquid unit are also collected and processed during regular maintenance. As a result, it is possible to provide a function of an automatic saliva inspection by performing regular maintenance and being unattended at normal times.

The block diagram which shows embodiment of the saliva collection instrument by this invention Illustration of saliva collection and dilution principle External view showing a saliva collecting device according to the present invention Block diagram for explaining the internal function of FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 ... Saliva inlet, 2 ... Contact part, 3 ... Contact vicinity part, 4a, 4b, 4c, 4d ... Pipe line, 5a, 5b ... Check valve, 6 ... Saliva chamber, 7 ... Dilution chamber, 8 ... Diluent , 9: Upper surface of the instrument, 10: Recessed portion of the upper surface, 11: Lower surface of the instrument, 12: Stepped portion of the lower surface, 13: Rear surface of the instrument, 14: Side surface of the instrument, 15 ... Saliva collection instrument, 16 ... Slot for inserting the saliva collection instrument, 17 ... Fixed Slider, 18 ... Cam mechanism, 19 ... Stopper, 20 ... Device outline, 21 ... Operation panel, 22 ... Control unit, 23 ... Helium gas, 24 ... Saliva collection instrument insertion port, 25 ... Cleaning unit, 26 ... Saliva collection instrument collection Outlet, 27 ... recovery unit, 28 ... waste fluid unit, 29 ... automatic saliva inspection system, 30 ... saliva dilution function unit, 31 ... subject.

Claims (5)

Connected between the saliva inlet directly into the subject's mouth and blowing saliva, a saliva chamber for stocking saliva, a dilution chamber containing a predetermined amount of diluent, and the saliva inlet and saliva chamber A first conduit, a second conduit connecting the saliva chamber and the dilution chamber, and a check valve disposed in the middle of the first conduit ;
The internal volume of the saliva chamber is changed by external pressurization to the saliva chamber, and the saliva is measured and transported to the dilution chamber based on the change, and the check valve is used to transfer the saliva to the saliva inlet side. A saliva collecting device characterized by preventing backflow and further mixing saliva with a diluting solution by external vibration to enable rapid dilution of saliva. The saliva collection device according to claim 1, wherein a check valve is also arranged in the middle of the second pipe line to prevent the liquid in the dilution chamber from flowing back to the saliva chamber side. 3. The material according to claim 1, wherein a material having flexibility, biocompatibility, and safety is used as a member of a contact portion that is directly applied to the mouth of the subject in the saliva injection port. Saliva collection device. The taper imparted to the outer portion of the contact opening near the saliva-collecting tool according to any one of claims 1-3, characterized in that a shape adapted to the size of the child up to the adult mouth . The claims 1 to saliva sampling instrument insertion port for inserting one of the saliva collecting device 4, a locking slide which direct the insertion path to transport the saliva chamber of the inserted saliva-collecting tool pressurized while It has a cam mechanism and a stopper for positioning and fixing the conveyed saliva collection device, and further has a function of applying vibration to the saliva collection device, and automatically inside the inserted saliva collection device. A saliva collecting device characterized in that saliva is weighed and transported appropriately and quickly, mixed with a diluent, and diluted.

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