Saliva sample extractor

Abstract

The invention relates to a saliva sample extractor for the non-invasive collection of saliva samples, particularly from infants. The saliva sample extractor is designed as a pacifier and comprises a teat (1) formed as a shape-elastic bladder with an inner cavity (7) for saliva collection. The wall of the teat (1) has at least one wall section made of a fluid-selectively permeable membrane (6), through which saliva fluid (8) can pass into the inner cavity (7). The teat (1) also has a vent opening closed by a one-way valve (5). Saliva collection occurs passively through natural sucking and chewing movements. The saliva sample extractor ensures hygienic, stress-free, and efficient saliva collection, which is particularly suitable for infants and uncooperative patient groups.

Description

[0001] The invention relates to a saliva sample extractor for the non-invasive collection of saliva samples for medical testing purposes. It is particularly suitable for saliva sampling from infants.

[0002] Saliva sampling for diagnostic purposes is an established procedure in medicine and research. It is used, among other things, for the analysis of hormones, enzymes, and genetic material, as well as for the identification of pathogens. Unlike invasive methods such as blood sampling, saliva samples offer a painless alternative, particularly preferred in pediatrics and with uncooperative patient groups.

[0003] Common methods for saliva collection include the use of cotton swabs, saliva collection tubes with absorbent materials, or special spittoons that allow for direct collection. In practice, saliva sampling often requires a certain degree of cooperation from the person being tested, as many systems require active saliva release or the suction of saliva onto absorbent materials. This poses a particular challenge for infants and young children, as they cannot consciously participate in sample collection. A key prerequisite for ensuring the quality of medical tests using saliva samples is correct saliva extraction. The required amount of saliva and the sometimes difficult cooperation of test subjects, especially infants, can complicate the procedural efficiency of saliva testing.

[0004] In addition to manual collection, there are also automated and technical solutions that stimulate saliva flow or obtain larger sample volumes through mechanical suction.

[0005] Despite various advances, saliva sampling remains cumbersome, inefficient, or inadequately adapted to the specific needs of certain patient groups in many areas.

[0006] The object of the invention is to provide a device for saliva sampling that enables reliable, hygienic, and efficient collection of saliva samples. This should ensure that a sufficient sample quantity can be collected without requiring any special cooperation from the test subject. Furthermore, the method should be simple to use, highly user-friendly, and suitable for use with various patient groups, especially infants, but also with uncooperative individuals. Furthermore, the collected saliva sample should be able to be safely stored and preserved in a stable form for subsequent diagnostic examinations without any contamination or changes in sample quality.

[0007] This object is achieved by a saliva sample extractor for taking saliva samples having the features of claim 1. Advantageous developments of the invention are set out in claims 2 to 10.

[0008] According to the invention, the saliva sample extractor for taking a saliva sample formed from saliva fluid is designed as a pacifier - colloquially known as a pacifier or, in technical terms, a pacifier. This saliva sample extractor designed as a pacifier comprises, in accordance with the conventional design of pacifiers, a teat, a mouth plate (also called a shield), and a holding button. The teat and the holding button are arranged on opposite sides of the mouth plate, i.e., the teat is located on the side that is in the mouth during use, and the holding button is on the opposite side, which is outside the mouth in the environment. The teat is, as is usual with pacifiers, in the form of a shape-elastic bladder with a wall made of an elastic wall material that encloses an inner cavity.

[0009] According to the invention, the teat or the shape-elastic bladder has a vent opening, wherein the teat is attached to the mouth plate and / or the mounting knob in such a way that the vent opening is open to the side of the teat opposite the mouth plate, i.e., to the ambient side. The vent opening is closed with a one-way valve that allows the outflow of air, primarily from the inner cavity of the teat, and simultaneously restricts or prevents the inflow of air into the inner cavity of the teat. The one-way valve does not have to be completely sealed in the inflow direction, i.e., a slight, significantly obstructed backflow of air can be tolerated.

[0010] The teat, which, according to the usual design of conventional pacifiers, comprises a teat tip, a teat neck, and a teat base along its length, is attached to the mouth plate or the retaining knob via the teat base. The vent of the bladder forming the teat is located at the teat base. Since the vent opens on the side of the teat opposite the mouth plate, a corresponding opening is provided in the mouth plate and / or the retaining knob, in the area of ​​which the one-way valve is usually located.

[0011] According to the invention, the wall of the shape-elastic bladder forming the teat is formed, at least in one wall section, from a liquid-selectively permeable membrane. This liquid-selectively permeable membrane, for example a hydrophilic or microporous membrane, is designed such that the wall is permeable to saliva in this area, but the passage of gases is blocked or at least impeded. This means that the saliva can pass through the wall section formed from the liquid-selectively permeable membrane and collect in the inner cavity of the teat. The inner cavity thus forms a collection reservoir for the saliva sample. Within the extension of the teat, the collection reservoir is usually located in the area of ​​the usually widened teat tip.

[0012] The saliva sample extractor works on a passive and non-invasive method of collecting saliva, which utilizes the natural sucking and chewing movements of the saliva sample extractor, which is designed as a pacifier. Since pacifiers are often used to calm infants and toddlers, the saliva sample extractor is primarily intended for these groups, but can also be used on adults.

[0013] For example, when an infant holds the saliva sample extractor in the mouth and sucks or chews on it, the elastic deformation of the shape-elastic bladder forming the nipple displaces air from the inner cavity. The air escapes through the vent, which is equipped with a one-way valve. The one-way valve allows air to flow out of the nipple's inner cavity while simultaneously preventing air from flowing in. As the shape-elastic bladder strives to return to its original shape, a negative pressure develops in the nipple's inner cavity.

[0014] This negative pressure causes saliva to be sucked from the oral cavity through the wall section of the suction device, formed by the fluid-selectively permeable membrane, into the inner cavity. The saliva thus collects in the inner cavity, i.e., in the collection reservoir.

[0015] As the infant continues to suck or chew on the teat, this process repeats continuously. The combination of the fluid-selectively permeable membrane, the one-way valve, and the flexible, shape-elastic bladder ensures continuous saliva collection until the collection reservoir is filled with a sufficient amount of saliva for the saliva sample. The one-way valve preferentially expels the air within the teat, while the one-way valve largely retains the saliva. This is due to the fact that gases can pass through the one-way valve more easily than liquids.

[0016] After the saliva sample has been collected, the saliva sample extractor can be removed, and the collected saliva sample is protected from contamination by the closed one-way valve. The resulting saliva sample can then be further processed for diagnostic purposes.

[0017] The inventive design of the saliva sample extractor ensures passive, continuous, and hygienic collection of saliva fluid without requiring conscious, active participation by the test subject or manual collection by a third party. The entire functionality is designed to be intuitive and ensure the saliva sample remains stable until needed for diagnostic testing.

[0018] The pacifier design creates a natural and intuitive method for collecting saliva samples, making it particularly suitable for infants and toddlers, as they can use the saliva sample extractor without conscious, active intervention or discomfort. This reduces stress and resistance on the part of the child and allows for continuous, unobtrusive saliva collection throughout everyday life. The saliva sample extractor is particularly suitable for collecting saliva samples from infants because it utilizes the infant's natural chewing and sucking reflexes to obtain saliva samples.

[0019] The saliva sample extractor requires no medical training or professional background, making it easy for parents or caregivers to use. Saliva sampling is carried out particularly gently, without any discomfort for infants or young children. Furthermore, the device is characterized by efficient extraction, which does not require the use of moving parts, electric motors, or other drive mechanisms.

[0020] The saliva sample extractor allows for convenient and efficient collection of saliva from a test subject's mouth, especially from an infant's mouth, for collection and preservation of the saliva sample, and for forwarding it to a testing laboratory. It itself forms a sufficiently stable container and an optimal microenvironment for the temporary storage and transport of saliva samples.

[0021] In addition, the proposed saliva sample extractor is reusable and recyclable.

[0022] Furthermore, compared to the sampling devices used in conventional saliva sampling methods, the saliva sample extractor according to the invention allows for significantly larger sample volumes to be collected or extracted. By capturing a relatively large storage volume, incorrect measurements or inaccuracies in saliva sample analysis can be avoided or minimized.

[0023] The saliva sample extractor according to the invention can be designed to be easily disassembled and easy to clean, ensuring that all components, in particular the one-way valve and the fluid-selectively permeable membrane, can be cleaned and / or sterilized without damage. For this purpose, the saliva sample extractor can comprise removable components, including the fluid-selectively permeable membranes.

[0024] The materials of the individual components should be selected taking into account the requirements for cleaning and sterilization to ensure the longevity and safety of the saliva sample extractor. Proven materials from the manufacture of conventional pacifiers serve as a guide for material selection.

[0025] The one-way valve and the wall sections with the fluid-selectively permeable membrane are ideally coordinated in terms of design and positioning so that saliva extraction occurs without excessive chewing force.

[0026] According to one embodiment, the one-way valve, which is located at the vent opening of the suction device and allows air to escape from the internal cavity, is designed as an elastic check valve, also known as a check valve with an elastic flap. In particular, the elastic check valve is a so-called duckbill valve. Due to the typically one-piece design of the valve body, this type of one-way valve is reliable, low-maintenance, and easy to clean.

[0027] According to another embodiment, the one-way valve is designed as a Tesla valve. This utilizes a fluid-dynamic design that, through a special arrangement of channel geometries, enables flow in a preferred direction and largely prevents backflow due to resistance mechanisms within the valve structure. This construction ensures passive and mechanical-free control of the flow direction, allowing the saliva sample extractor to function reliably without moving parts or external power supply. The Tesla valve design of the one-way valve also offers a high degree of reliability, low maintenance, and easy cleaning.

[0028] The one-way valve is preferably made of a medical-grade material, such as a silicone material or a similar elastomer.

[0029] The fluid-selectively permeable membrane in the wall of the bladder forming the suction device is, as already described, designed to be permeable to saliva while preventing or at least hindering the passage of gases. Its functionality is based on a combination of physical effects, including capillary forces, surface tension, pore size, Laplace pressure, and diffusion mechanisms, which together enable selective permeability to fluids. The choice of material is crucial to ensure the desired selectivity and efficiency of fluid absorption. Membrane materials with, for example, a microporous structure or hydrophilic properties can be used for this purpose.

[0030] One group of suitable materials for the liquid-selective permeable membrane are hydrophilic polymers, which, due to their chemical structure, can specifically attract and retain water. One example is hydrophilic polyurethane (PU), which enables rapid liquid absorption due to its high water affinity. This is achieved by the wetting effect, whereby water penetrates the liquid-selective permeable membrane through interactions with the polymer surface. The liquid is transported by capillary forces within the pore structure, while at the same time, the low gas solubility in the hydrophilic matrix prevents the diffusion of air molecules. This selective permeability is further supported by the size distribution of the pores, which are small enough to generate a Laplace pressure that retains the air.Other materials from this group of hydrophilic polymers that can form the liquid-selectively permeable membrane include, in addition to hydrophilic polyurethane, hydrophilic cellulose acetate, hydrophilic silicone, hydrogels or polyvinyl alcohol.

[0031] Another material group suitable for the formation of a fluid-selective permeable membrane is microporous polymers, which allow fluids to flow through their specifically defined pore structure, while air molecules are prevented from penetrating due to their lower capillary force and surface tension. One example is microporous silicone, whose pore size is specifically selected so that saliva is drawn into the fluid-selective permeable membrane by capillary forces. At the same time, the surface tension of the silicone ensures that gases cannot diffuse through the fine pores due to their low cohesion. This creates a physical barrier for air, while the fluid is transported in a controlled manner into the inner collection reservoir of the suction device.Other possible membrane materials from this material group are microporous polyethersulfone (PES) and microporous polyvinylidene fluoride (PVDF).

[0032] It can further be provided that the wall of the structure forming the bladder of the teat is constructed from a base material into which at least one wall section formed from the liquid-selectively permeable membrane is embedded. This means that the bladder of the teat does not consist entirely of the liquid-selectively permeable membrane, but rather contains only one or preferably several of the wall sections made of the liquid-selectively permeable membrane. However, the wall of the bladder is primarily constructed from the base material—apart from embedded wall sections made of the liquid-selectively permeable membrane.

[0033] The base material thus forms the main structure of the teat's bladder and provides the necessary mechanical dimensional stability and elasticity, while the wall section(s) made of the fluid-selectively permeable membrane enable the targeted absorption of saliva into the teat's inner cavity. This hybrid design, whose wall is primarily formed from the base material, maintains the familiar feel and security of conventional pacifiers while simultaneously achieving the functionality required for saliva collection.

[0034] The wall sections made of the liquid-selectively permeable membrane are preferably arranged so that they are in areas of the teat that come into particularly heavy contact with saliva and where saliva collection is therefore most effective. These are, for example, the areas next to or around the collection reservoir, i.e. usually the tip area and the widest area of ​​the teat tip. Since the base material in this design forms the main structure of the teat's bladder, conventional teat materials from pacifiers can be used as the base materials; these are known for their durability, flexibility, and comfort. The wall sections made of the liquid-selectively permeable membrane can therefore be integrated into the teat in a way that does not impair its function as a sedative and whose feel is no different from that of conventional pacifiers.

[0035] Medical-grade silicone or natural rubber (latex) is particularly suitable as a base material. The choice of medical-grade silicone or natural rubber as the base material ensures high elasticity, biocompatibility, and mechanical stability, allowing the bladder of the teat to be optimally utilized in its function as a shape-elastic structure.

[0036] The collection reservoir for the saliva sample preferably has a volume in the range of 0.3 ml to 1.4 ml. This means that the inner cavity of the suction device, which serves as the collection reservoir, has a defined capacity that allows for reliable collection and storage of the saliva fluid in a quantity suitable for sampling. This ensures that a sufficient amount of saliva can be collected for subsequent tests without the collection reservoir being excessively large.

[0037] It can also be provided that the one-way valve is integrated into the holder button of the pacifier. This means that the one-way valve, which allows outflow from the inner cavity of the pacifier and at least impedes inflow into the inner cavity of the pacifier, is located within the holder button and not arranged separately on the pacifier or the mouth plate. Integrating the one-way valve into the holder button ensures that the function of the one-way valve remains in a protected and stable position within the saliva sample extractor.

[0038] The saliva sample extractor may further include a replaceable cap, which serves to hermetically seal the one-way valve after the saliva sample has been collected. After the saliva sample has been collected using the saliva sample extractor, the cap is placed over the one-way valve to seal the saliva sample collection reservoir against external influences. This contributes to the protected storage of the saliva sample and prevents changes in sample quality that could be caused by contact with the environment.

[0039] According to a further embodiment of the saliva sample extractor, the suction device is equipped with a fill level indicator. This means that the suction device has a device or marking that allows the fill level of the saliva sample contained in the collection reservoir to be visually or mechanically detected.

[0040] Generally, the saliva sample extractor is designed to be comfortable to wear and free of sharp edges or hard components that could pose a risk of injury to the user. All materials used should be safe, non-toxic, and hypoallergenic.

[0041] Further and supplementary embodiments and developments of the described technology are described in the German patent application with the application number DE 10 2024 105 332.1, to which reference is made in this respect and the contents of which are hereby incorporated into this patent application.

[0042] The invention is explained in more detail below using an exemplary embodiment and with reference to the schematic drawings, in which identical or similar features are provided with the same reference numerals; in this case: Fig. 1: the saliva sample extractor in perspective view, Fig. 2: the saliva sample extractor in perspective view with partial exposures, Fig. 3: the functionality of the one-way valve designed as an elastic check valve in two cross-sectional views, and Fig. 4: The functionality of the one-way valve designed as a Tesla valve in two cross-sectional views.

[0043] The saliva sample extractor designed as a pacifier or pacifier comprises Fig. 1 and Fig. 2 the suction cup 1, the mouth plate 2, and the retaining knob 3. The suction cup 1 is designed as a shape-elastic bubble and is divided along its length into the areas of the suction cup tip 1.1, the suction cup neck 1.2, and the suction cup base 1.3. The mouth plate 2 is arranged between the suction cup 1 and the retaining knob 3 and serves as a boundary between the user's oral cavity and the outer area of ​​the saliva sample extractor facing the environment. The suction cup 1 is connected to the mouth plate 2 and the retaining knob 3 at its suction base 1.3. The retaining knob 3 is provided with a retaining ring 4, which enables safe handling and stable fixation of the saliva sample extractor.

[0044] The suction cup 1 encloses, as shown in the partial exposure in Fig. 2 illustrates the cavity 7, which serves as a collection reservoir for the saliva 8. At least one wall section of the suction device 1 is formed from the fluid-selectively permeable membrane 6, which allows the passage of the saliva 8 into the cavity 7, while the passage of air 9 is prevented or at least severely hindered. In the embodiment according to Fig. 1 and Fig. 2, the wall of the suction cup 1 is formed primarily from the base material silicone or natural rubber, i.e., it is designed as an elastomer membrane. Embedded within this membrane are several wall sections made of the fluid-selectively permeable membrane 6.

[0045] The vent opening is formed on the teat base 1.3 and is open to the side of the teat 1 opposite the mouth plate 2, i.e., to the ambient side. The vent opening is closed with a one-way valve 5. The one-way valve 5 ensures that air 9 can escape from the cavity 7 of the teat 1, while at the same time at least obstructing the inflow of air 9. The partial exposure in Fig. 2 shows an elastic check valve 5.1 as a one-way valve 5.

[0046] During use, the person being tested, preferably an infant or toddler, places the teat 1 in their mouth and typically performs sucking or chewing movements reflexively. This forces air 9 out of the cavity 7 through the one-way valve 5, creating a negative pressure in the cavity 7. This negative pressure causes saliva 8 to be drawn through the fluid-selectively permeable membrane 6 into the cavity 7. The saliva 8 is collected in the cavity 7, while the one-way valve 5 prevents air 9 from flowing back into the cavity 7.

[0047] The representations in Fig. 3 and Fig. 4 show variants of the one-way valve 5, which are basically known from the prior art, namely in Fig. 3 the design of the one-way valve 5 in the form of an elastic check valve 5.1 (duckbill valve) and in Fig. 4 the design of the one-way valve 5 in the form of a Tesla valve 5.2.

[0048] Fig. Figure 3 illustrates the functionality of the one-way valve 5, designed as an elastic check valve 5.1, in two cross-sectional views. The first cross-sectional view, Fig. 3 (a), shows the one-way valve 5 in the closed state, while the second cross-sectional view, Fig. 3 (b), shows the open one-way valve 5 through which air 9 can escape from the cavity 7 of the suction cup 1. In the first cross-sectional view, Fig. 3 (a), the elastic check valve 5.1 is shown in its initial position, in which it remains closed and prevents air 9 from flowing back into the cavity 7. The elastic flaps of the elastic check valve 5.1 ensure that it only opens at a certain internal pressure.

[0049] Fig. Figure 4 shows the functionality of the one-way valve 5, designed as a Tesla valve 5.2, in two cross-sectional views. The first cross-sectional view, Fig. 4 (a), shows the Tesla valve 5.2 with flow in the blocking direction, while the second cross-sectional view, Fig. 4 (b) shows the flow in the flow direction, with air 9 escaping from the cavity 7 of the suction device 1. The one-way valve 5, designed as a Tesla valve 5.2, uses a fluid-dynamic design with a special channel geometry that directs the air flow in a preferred direction and largely prevents backflow due to resistance mechanisms within the valve structure. List of reference symbols 1 vacuum cleaner 1.1 Suction tip 1.2 Teat neck 1.3 Suction cup base 2 mouth plate 3 Bracket button 4 retaining ring 5 One-way valve 5.1 elastic check valve 5.2 Tesla valve 6 liquid-selective permeable membrane 7 Cavity 8 Saliva 9 Air QUOTES CONTAINED IN THE DESCRIPTION

[0000] This list of documents submitted by the applicant was generated automatically and is included solely for the convenience of the reader. This list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions. Cited patent literature

[0000] DE 10 2024 105 332.1

[0041]

Claims

[1] Saliva sample extractor for taking a saliva sample formed from a saliva fluid (8), characterized by that the saliva sample extractor is a pacifier comprising a teat (1), a mouth plate (2) and a holding button (3), wherein the teat (1) and the holding button (3) are arranged on opposite sides of the mouth plate (2), - wherein the suction device (1) is designed as a shape-elastic bladder with a wall made of an elastic wall material, which encloses an inner cavity (7) and has a vent opening, wherein the inner cavity (7) forms a collecting reservoir for the saliva fluid (8) of the saliva sample, - wherein the teat (1) is attached to the mouth plate (2) and / or to the mounting knob (3) in such a way that the vent opening is open to the side of the mouth plate (2) opposite the teat (1), wherein the vent opening is closed with a one-way valve (5) which ensures the outflow from the inner cavity (7) of the teat (1) and at least obstructs the inflow into the inner cavity (7) of the teat (1), and - wherein the wall of the bladder forming the teat (1) is formed at least in one wall section from a liquid-selectively permeable membrane (6), wherein the wall of the bladder forming the teat (1) is permeable to the saliva fluid (8) in this wall section. [2] Saliva sample extractor according to claim 1, characterized by that the one-way valve (5) is an elastic check valve (5.1). [3] Saliva sample extractor according to claim 1, characterized bythat the one-way valve (5) is a Tesla valve (5.2). [4] Saliva sample extractor according to one of claims 1 to 3, characterized by that the liquid-selectively permeable membrane (6) is formed from hydrophilic polyurethane, hydrophilic cellulose acetate, hydrophilic silicone, a hydrogel, polyvinyl alcohol, microporous silicone, microporous polyethersulfone or microporous polyvinylidene fluoride. [5] Saliva sample extractor according to one of claims 1 to 4, characterized by that the wall of the bladder forming the suction device (1) is constructed from a base material into which the at least one wall section formed from the liquid-selectively permeable membrane (6) is embedded. [6] Saliva sample extractor according to claim 5, characterized by that the base material is medical silicone or natural rubber. [7] Saliva sample extractor according to one of claims 1 to 6, characterized bythat the collection reservoir for the saliva sample has a volume in the range of 0.3 ml to 1.4 ml. [8] Saliva sample extractor according to one of claims 1 to 7, characterized by that the one-way valve (5) is integrated into the holder button (3). [9] Saliva sample extractor according to one of claims 1 to 8, characterized by that it has a replaceable cap for hermetically sealing the one-way valve (5) after the saliva sample has been taken. [10] Saliva sample extractor according to one of claims 1 to 9, characterized by that the suction cup (1) is provided with a fill level indicator.

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