FI118625B - Implement for taking saliva samples - comprises hollow body with inner chamber for collection of saliva and made of pliable material - Google Patents

Abstract

The hollow body (1) has at least one perforation (4) for the passage of saliva from the exterior into the inner chamber (5). In the hollow body is an accommodation part (25) for receiving and removal of the saliva which has entered the inner chamber. The hollow body has the shape of the suction body of a rubber teat and is connected to a shield (9). In the shield a closure component (12, 13, 14) is releasably secured, which in the secured state cuts off the inner chamber of the suction against the atmosphere. The suction body has a first free end section (2) and a section opposite end section (3) by the shield. The at least one perforation is arranged at least in the area of the first end section.

Description

118625

Apparatus for saliva sampling - Anordning för tagande av salivprov

The present invention relates to a device for taking saliva samples for medical examination.

It is known that saliva can be used to detect and monitor secretions from drugs, hormones and antibodies (e.g. HIV antibodies). For example, it is now possible, for example, to measure in a very simple manner all salivary steroids of diagnostic importance in routine clinical endocrinology. Saliva is also extremely valuable for many extensive studies 10 and epidemiological studies. In many sub-clinical and clinical conditions, saliva may be used instead of blood. According to general criteria, the entry of drugs into saliva follows the passage of drugs through biological membranes. The non-plasma bound drug component diffuses into saliva. The benefits of saliva sampling in the pediatric and neonatal area are obvious, as taking 15 saliva samples is painless and blood-saving. In the study of children, saliva is recommended for therapeutic monitoring of phenytolines, carpazepines and phenobarbital. The use of saliva samples for diagnostic and therapeutic monitoring has proven promising in neonates and premature infants. Some diseases of the body,. . ·. for example, Sjögren's syndrome, cystic fibrosis, and adrenal cortex disorders: · ** 20 can affect the function of the salivary glands, which can be used as diagnostic aids in these diseases. For such medical facilities. , the list that can be identified and studied using oral fluid as a diagnostic medium is constantly growing.

• · · * · ·

In addition, salivary pathogens (disease-causing bacteria) are used as diagnostic tools to determine whether individuals are at risk for various oral diseases, such as dental caries or periodontitis. Pathogens 1a, for example mutant streptococci, Actinobacillus actinomycetemcomitans, B. gingivalis, F. nucleatum, etc., play an important role in the development of oral diseases. Because of the accumulation of pathogens in the mouth and dentition of infants:. 30 apparently carries a risk of future illness, it is important to detect such exposed individuals as early as possible, preferably as early as childhood. Calculation of bacteria present in saliva · · directly indicates the extent of aggregation in the target oral tissue. In the near future, bacterial sampling of saliva will become a routine procedure for examining mother-to-child pairs and for general observation of ter-35 health. The sooner the infiltration of pathogens is detected, the sooner the 2 118625 can be countered and thus the oral therapies strengthened, for example by using certain specific antibodies against said pathogens.

When sampling, such as saliva collection, does not present any difficulty for adults, it is virtually impossible for newborns, infants and young children.

Saliva delivery is an adult will commanded by will, and even opening the mouth is by command.

Such a procedure is impossible for newborns and infants. Still, no unknown foreign substances are tolerated by the child, and direct contact between the 10 absorbent saliva absorbent body and the child's mouth, teeth, etc., must be strictly avoided, particularly to prevent any breakage of the saliva absorption body, which could cause substantial harm to the child.

An example of such an unfavorable saliva absorber, the use of which requires direct contact, is described in WO-95/30484.

US-A-3 610 248 describes a chewing and chewing apparatus for young children, particularly used in the tooth eruption process. Said chewing device includes: a hollow, malleable chewing piece and a perforated wall mounted thereon; * *., a hydrophilic, full-fill filler insert. However, it is not possible to remove said 20 fillings from the chewing saliva. ·. ·, To make it possible.

The present invention relates generally to a device for reliably taking saliva samples from premature infants, newborns, and infants.

It is a further object of the invention to provide a salivary sampling device comprising a hollow body for receiving a fluid-absorbent portion to be removed from it and a closure member, said hollow body being made of a flexible member. :, .. ί of material, and includes at least one perforation to allow the saliva to pass through: · and a fluid-tight opening in the closure for mounting and removing the fluid-absorbing part.

The device according to the present invention is known from the features of independent claim 1. Recommended applications can be found in the independent requirements.

3, 118625

The advantages of the present invention are seen in particular in that the device enables the safe salvage of infants, newborns and young children, and that the hollow body can be shaped to be adopted by the child into his mouth.

Other objects and advantages of the present invention will become apparent from the following description, in which the invention will be described in more detail with reference to the accompanying drawings, in which Figure 1 is a vertical sectional view of the right teat end of Figure 1; Fig. 4 is a modification of the penetration opening of the nipple, Fig. 6 is a further modification of the penetration opening of the nozzle, Fig. 7 is an enlarged sectional view of Fig. 1, and the individual components 15 are shown separately for clarity, Fig. 2 is an enlarged view of Fig. 2, showing for clarity the individual components separately, Fig. 9 illustrates another embodiment of a device according to the present invention; and. . Figure 10 illustrates another modification of the pacifier.

The hollow body suction body 1, schematically depicted in sectional view in Fig. 1, side view in Fig. 3 and rear view in Fig. 4, includes a front, first free end member 2 and with the takim, ·. ·. earthly, second end 3.

* · · ·· «v: Elastic material suction cup 1 has the same shape and elasticity as conventional dummy suction cups. It provides a chewing functional ability advantageous to jaw orthopedics and a form that promotes jaw growth. For example, a soother with a suction cup of the kind mentioned is described in Swiss Patent Publication CH-PS (CH-A) -495,748, respectively.

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The front, first end piece 2 is provided with through holes 4: · *. 30 form holes that connect the entire interior 5 of the suction cup 1 to its outer surface 6, i.e., the surroundings. For said perforations, i.e. passage holes 4 will be returned to · · in more detail below.

4, 118625

In an area further away from the first end region 2, the second end region 3 of the suction cup 1 terminates in an opening, hereinafter referred to as the sampling port 7 (see Figure 3). Said sampling opening 7 is surrounded by a circumferential shoulder 8.

The suction body 1 is housed in a shield 9. Said shield 9 is convex in the embodiment described, as is generally the case with tufts. Of course, other shapes are also possible, such as outwardly convex or planar surfaces. The cover 9 includes a central opening 10 (Figs. 7 and 8) in which the second end piece 3 of the suction body 1 is disposed. It is obvious that the annular surface 11 facing the second end piece 3 of the peripheral projection 8 is sealingly bounded to the corresponding counter surface of the cover 9.

10 Shroud 9 is provided with a closure member comprising an inner member 12, an outer member 13 and a pivotally mounted fastening member 14. The inner member 12 is connected to the outer member 13 by a clamping connection as can be seen in particular from FIG. a projection portion 15. Said projection portion 15 extends into the suction receiving port 7 (Fig. 3). The cross-sectional shape of the projection 15 corresponds to the cross-sectional shape of the receiving opening 15. Thus, the outer peripheral surface 16 of the projection 15 is limited to the corresponding inner surface portion 17 of the second end piece 3 of the suction cup 1. Finally, the closure portion includes an inner portion 12 at the end of the projection 15 which is sealingly adjacent to the circumferential shoulder 8.

• · • «· • ·

A fastening portion 14 is pivotally attached to the outer portion 13 of the sealing member. Said fastening portion 14 includes a notched recess 19 on its outer surface, for example a chisel * *. for receiving a tool part for rotating the mounting part 14. The fastening part] / 14 includes two plate-like projections 20, 21 which engage the corresponding openings 22, 23 in the cover 9.

Thus, it is evident that the closure portion 12, 13, 14 is removably connected to the cover 9 via its attachment portion 14, and that, when locked, the circumferential blade 8 of the suction cup 1 is sealingly and locked in the cover 9 and the closure portion 12, 13, 14. between.

• · ·

The suction body 1 is provided with perforations 4 as passages. Figures 1 and 3 apply. said passageways 4 are disposed only in the front first 4 * end piece 2 and are distributed along said lined planar area 26 of said first end piece 2: ** 30. According to a second embodiment (not illustrated), only one passage opening is disposed in the center of said planar surface area 26, and the second passage opening is disposed on the opposite, i.e. slightly convex, wall of the first end piece. The central axis of the through openings need not necessarily be at right angles to the respective wall portions 5118625 of the first end piece 2. They may also be inclined at an angle with respect to the wall pieces and towards the other interior of the second end piece 3. Also, the penetration openings 4 do not have to be completely circular in cross-section. In still other embodiments, the cross-sectional shape may be elongated, for example lo-5. Further penetration openings may also be provided in the second end piece 3. Penetration openings or notches may not be required to form the perforations described above. According to a further embodiment, the suction body 1 or at least its anterior end body may be in the form of a mesh or tissue.

The passage openings 4, notches, etc. may include a cylindrical inner peripheral edge. According to the embodiment of Figure 5 10, the passage openings 4 are made so that they pass together in the direction of the interior space 5. In this way, backflow from the interior 5 outwards is resisted. At least partial contact of the edges of the penetration openings in the interior 5 is also possible. According to a further embodiment of Figure 6, the inner walls of the penetration openings 4 are rounded towards the outer surfaces 6 and the inner surfaces 24 of the suction body 1.

According to a further embodiment, each or each of the perforations, or at least a portion of the perforation, is provided with a small hose piece which extends from the inner wall of the suction piece 1 towards its interior. These small hose pieces help to prevent saliva that has accumulated in the interior from flowing through the perforations back into the oral cavity.

• · • · · • *. ·. A fluid-absorbing member 25 is disposed in the interior space 5 of the suction body 1. This is in the form of a elongate plate. In general, it may be osmotic in structure such that "it collects a sufficient amount of pure fine filtrate which does not contain molecules larger than 120000 Daltons. Other absorption structures having good absorptivity and good absorption, e.g. an inert drug wool, fibrous materials, (Fibrella) rolls / pads, foam, and any sterilizable material may be used.

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In addition, saliva leakage can be stimulated by the addition of citric acid • · · * to the absorption structure. or xylitol or other appropriate stimulants. Such stimulation is advisable for the analytical utility of the oral solution for certain small molecules, but not for large molecules. When studying and observing mucus and • · ·] containing large molecules. meningeal fluids, which are relevant, for example, in the diagnosis of infectious diseases, should be collected without the use of stimulants.

Preferably, a color indicator is used which is colored either blue or some other color when the inert osmotic structure or the absorption structure, respectively, is sufficiently wetted for further treatment. Such color indicators are generally known. According to a further embodiment, the fastening portion 14 and at least the portion of the projection 15 are made of as transparent a material as possible so that the teat does not need to be removed from the mouth to detect discoloration.

To take a saliva sample, a small child is given a mouth-like pacifier instead of the usual pacifier that he or she normally uses. Since the shape of the suction cup 1 corresponds to the shape of a known conventional soother (the suction cup need not necessarily have the shape illustrated in the drawings) in which the young child 10 is accustomed, the child will not detect a change, i.e. the toddler approves a pacifier for saliva sampling. When the suction mouth is in the mouth, saliva flows through the penetration openings 4 into the interior space 5 of the suction body 1, and it irrigates the absorbent structure 25 located in the interior space during periodic suction movements of the infant at least the first end end 2 of the suction body 1. intermittent low vacuum may occur so that the saliva on the outside of the suction body 1 is effectively pumped into the interior 5.

After a few minutes, that is, after the color indicator has stained, the pacifier is removed from the mouth and the baby is given the previously used pacifier.

· 7 118625 boiling portions 25. Further, the passage openings 4 are not located in the anterior end region of the suction body 1 but at a certain distance from the anterior end region, as shown in Figure 9.

The hose body 27, preferably a micropipette, is rearwardly directed to the suction body 1 and terminates shortly before the front partition of the body. Said micropipette 27 is coupled with an aspirator 28 to a structure known per se.

The mode of operation of this embodiment is as follows: saliva flowing through the passageways 4 collects in the forward space portion of the suction body 1, which has no passageways 4 and terminates in the micropipette. After a sufficient amount of saliva has accumulated-10 in the space now mentioned, the saliva can be removed from the suction cup 1 using an aspirator 28 and can be analyzed clinically as previously mentioned.

Fig. 10 shows a modification of the nipple, in which the suction body 1 and the cap 9 in particular consist of one larger, molded part. At its rear, the suction body 1 is closed by a simple flap 29, which is bent to the housing 9. Said adapter 15 can be used with both the fluid-absorbing body 25 of Figure 1 and the micropipette 27 of Figure 9 and an aspirator attached thereto. As an example, the variant of Figure 1 is illustrated.

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Claims (7)

An apparatus for taking saliva samples, comprising a hollow piece (1) with an inner compartment (5) for collecting saliva and made of flexible material, and providing at least one perforation (4.4A, 4B) to enable saliva passing from outside into the interior space (5); wherein the hollow piece (1) has a receiving portion (25, 27) for receiving and removing saliva which has come into the interior space (5) and at the same time has the shape of the suction piece of a comfort button and is connected to a guard. ; (9) in which detachably and legibly a locking member (12, 13, 14, 29) is mounted, wherein said * ·: ·. 20 in its Iastä state separates the inner space (5) of the suction piece from the environment, characterized in that the suction piece contains a first, free-standing end piece (2) and a second, opposite the first positioned and inside the cover (9). ), the receiving portion for receiving and removing saliva collected in the inner compartment (5) forms part of a hose piece (27) ending at the end of the first end piece (2), in its the opposite end extends through the locking member (12, 13, 14, 29): * ·· and the task of which is to connect the device to a suction device (28) for collected saliva, ϊ, ϊ and that the perforation (4) is arranged only in the second end piece (3) of the suction piece. Device according to Claim 1, characterized in that the hose piece (27) is *: **: passed as a micropipette and that the suction means is an aspirator (289. · «· Device according to claim 2, characterized in that it has a plurality of perforations (4, 4A) in the form of continuous heel, each of which a continuous heel is made continuous in the direction of the interior space (5). 118625 ίο Device according to Claim 1 or 2, characterized in that it has a plurality of perforations (4, 4B) in the form of through-going heels, each of which has an inner periphery which is rounded to the outer and inner parts of the suction piece (1). surface. An apparatus for taking saliva samples, comprising a hollow piece (1) with an inner compartment (5) for collecting saliva and made of flexible material and exhibiting at least one perforation (4.4A, 4B) to enable saliva passing outside to the interior space (5); wherein the hollow piece (1) has a receiving portion (25, 27) for receiving and removing saliva which has entered the interior space (5) and at the same time has the shape of the suction piece of a comfort button and is connected to a cover (9). , in which removably and legibly a locking member (12,13,14,29) is mounted, said locking member in its Iastä state separating the inner space (5) from the environment, characterized in that the receiving part for receiving and removing saliva collected in the the inner compartment consists of a removable, liquid-absorbing portion (25) of the suction piece. Apparatus according to claim 5, characterized in that it comprises a plurality of perforations, (4, 4A) in the form of through-going heels, each of which through-going heels being made together in the direction of the interior space (5). Device according to Claim 5, characterized in that it comprises a plurality of: 1 2 3 · 1: 20 perforations (4, 4B) in the form of a continuous heel, each of a passage · ·. the braid includes an inner periphery which is rounded to the outer and inner surface of the suction piece (1). ·· 1 e • · • ·· * * · • · 1 · · · · · · · · · · · · · · ··· · 1 · ··· · # • · 2 • · 3 * · ··· ··· ·· «• 1 •« ···