Applicator for positioning absorbable matrix elements within a lumen and collection kit for collecting biological secretions

Abstract

The present disclosure relates to an application device (100) applicable for positioning an absorbent matrix (AM) element (10) in a cavity of a human or animal body, the application device (100) comprising: a storage and discharge tube (101) configured to store and discharge the AM element (10); the AM element (10) stored within an interior space (102) of the tube (101); a discharge element (106) slidably supported relative to the tube (101) along the longitudinal axis (L) of the tube (101); and at least one deflection means (110) capable of bending the AM element (10) away from the longitudinal axis (L) of the tube (101) when the AM element (10) is discharged from the tube (101). The present disclosure further relates to a collection kit comprising the application device (100). The present disclosure further relates to the use of the application device (100) or the collection kit for collecting nasal secretions.

Description

Technical Field

[0001] The present invention relates to an application device for positioning an absorbent matrix (AM) element within a body cavity of a human or animal body, and a collection kit comprising the application device. The present invention further relates to the use of the application device or a collection kit for collecting nasal secretions.

Background Art

[0002] Nasal secretions from the nasal cavity contain a number of proteins. These proteins are, for example, biological markers of inflammatory processes. Therefore, the analysis of nasal secretions is a scientifically and medically interesting field. In order to investigate inflammatory processes and allergies, the analysis is generally performed on secretions collected from the lower and central parts of the nasal cavity.

[0003] To collect nasal secretions, various sampling techniques are used, such as nose blowing, suction, nasal irrigation, nasal adsorption, etc. In nasal adsorption, an adsorbent such as a sponge, a cotton swab, a synthetic adsorption matrix (SAM) element, etc. is placed in the nasal cavity for a short time (e.g., 1 minute). When collecting nasal secretions from the upper part of the nasal cavity, more specifically from the olfactory cleft, the olfactory cleft is located at the upper part of the nose, is difficult to reach, and is dangerously close to the skull base. Therefore, it is generally difficult to place the adsorbent.

[0004] It is known that there is a significant variation in the amount of protein captured by different sampling techniques. For example, in nasal irrigation, the dilution of secretions cannot be controlled, and markers may be lost from the oral / nasopharynx. Therefore, data from different studies using different sampling techniques cannot be compared, which has hindered further research in this field. Even with the same sampling technique, there may be variations in the collected nasal secretions. For example, in the case of nasal adsorption, variations may occur due to the difficulty of correctly and reproducibly placing the adsorbent at the intended target location (e.g., the olfactory cleft), and / or contamination of the adsorbent due to damage or irritation of the nasal mucosa when inserting the adsorbent into the nose.

[0005] While problems with collecting nasal secretions are known, there are no standard procedures for collecting nasal secretions, particularly from the upper part of the nasal cavity. Similarly, there are no standardized tools for collecting nasal secretions.

[0006] Therefore, a new tool is needed to collect nasal secretions. [Overview of the project]

[0007] In a first embodiment, the present invention relates to a coating apparatus applicable for positioning absorbent matrix (AM) elements within a cavities in the body of a human or animal, wherein the coating apparatus comprises: A containment and discharge tube having a distal end and a proximal end, configured to contain and discharge AM elements, • The AM element is housed within the internal space of the tube, • An emission element slidably supported relative to the tube along the longitudinal axis of the tube, configured to emit AM elements from the tube, • At least one deflection means organized at the distal end of the tube, which can bend the AM element away from the longitudinal axis of the tube when the AM element is ejected from the tube, Equipped with, The AM element is not attached to any of the tubes, emission elements, or deflection means.

[0008] In a second aspect, the present invention relates to a collection kit applicable for collecting biological secretions from cavities of the body of a human or animal, comprising the application apparatus of the present invention, wherein the collection kit further comprises a container arrangement for storing AM elements after the collection of secretions.

[0009] In a third aspect, the present invention relates to the use of the application apparatus of the present invention or the collection kit of the present invention for collecting nasal secretions. [Brief explanation of the drawing]

[0010] [Figure 1] This is a fluoroscopic view of the human nasal cavity, showing AM elements released to collect secretions. This fluoroscopic view is shown in semi-transparent form. [Figure 2A] This is a perspective view of a first embodiment of the coating apparatus according to the present invention, showing that the AM element is in its retracted (retracted) position and partially in its discharge position. [Figure 2B] Figure 2A shows a magnified view of detail X. [Figure 3A] This is a perspective view of a second embodiment of the coating apparatus according to the present invention, showing that the AM element is partially located at its discharge position. [Figure 3B] Figure 3A shows a magnified view of detail Y. [Figure 4] This is a perspective view of a third embodiment of the coating apparatus according to the present invention, showing the AM element in its retracted (storage) position. [Figure 5] An embodiment of an AM element suitable for a coating apparatus according to the present invention is shown. [Figure 6] A cross-sectional view of a container configuration suitable for storing and / or transporting AM elements after secretion collection is shown. [Modes for carrying out the invention]

[0011] In a first embodiment, the present invention relates to a coating apparatus applicable for positioning absorbable matrix (AM) elements within a body cavity of a human or animal, wherein the coating apparatus comprises: A containment and discharge tube having a distal end and a proximal end, configured to contain and discharge AM elements, • The AM element is housed within the internal space of the tube, • An emission element slidably supported relative to the tube along the longitudinal axis of the tube, configured to emit AM elements from the tube, ·At least one deflecting means configured at the distal end of the tube, the deflecting means being capable of bending the AM element away from the longitudinal axis of the tube when the AM element is released from the tube. comprising The AM element is not attached to any of the tube, the discharge element, or the deflecting means.

[0012] The application device of the present invention is applicable for positioning the AM element within the cavity of the human or animal body. The AM element will be positioned within the cavity, for example, in a non-invasive manner to collect biological secretions from the cavity. The secretions are collected by absorption of the secretions by the AM element. Thus, the application device can also be referred to as a collection device or a collecting device. The collection process can also be referred to as an extraction process.

[0013] The absorbent matrix of the AM element, also referred to as the absorbent material, can be a synthetic absorbent matrix, a non-synthetic absorbent matrix, or a mixture of a synthetic absorbent matrix and a non-synthetic absorbent matrix.

[0014] In the case of a synthetic absorbent matrix, the AM element is also referred to as a synthetic absorbent matrix (SAM) element.

[0015] In the case of a non-synthetic (i.e., natural) absorbent matrix, the matrix is preferably a cotton matrix or a cellulose matrix.

[0016] The cavity is preferably the nasal cavity. The application device is particularly suitable for positioning the AM element at the upper part of the nasal cavity, more specifically in the olfactory cleft, and thus for collecting nasal secretions from this region. The olfactory cleft is a narrow passage located at the upper part of each of the left and right nasal cavities. The olfactory cleft has a special membrane different from other parts of the nasal cavity, namely, the olfactory epithelium. Thus, with a few exceptions, different types of mucosal surfaces are present in the remaining part of the nasal cavity. The nasal septum, middle turbinate, and inferior turbinate are not covered by the olfactory epithelium.

[0017] Therefore, one of the most relevant applications of the application device can be seen in positioning the AM element at the upper part of the nasal cavity to collect nasal secretions from this area. The nasal secretions collected from this area include nasal secretions located above and in the middle of the upper layer of the olfactory epithelium. The dimensions of the AM element are selected along the entire extension in the sagittal direction and the entire width of the olfactory cleft to facilitate the collection of nasal secretions. The analysis of nasal secretions is a field of increasing scientific and medical interest. For example, for some diseases, the analysis of nasal secretions may be used as a widely available non-invasive diagnostic approach.

[0018] The nasal secretions are preferably collected from the olfactory clefts of the left and right nasal cavities of the subject. For this purpose, one application device is applied to each cavity. The collection may be performed simultaneously. After collection, the secretions from the left and right nasal cavities may be combined for further analysis.

[0019] In another example, the cavity is the oral cavity. The application device is suitable for positioning the AM element, for example, between the buccal mucosa of the cheek and the teeth of the upper or lower dental arch to collect secretions from this area. In this case, the biological secretion collected is saliva. After collection, the saliva may be analyzed, for example, for the presence of human papillomavirus (HPV). HPV-related tumors of the oral cavity, such as oral squamous cell carcinoma, are a common form of cancer. Also, the saliva may alternatively be analyzed for herpes simplex virus-related proteins.

[0020] In yet another example, the cavity is the eustachian tube. In this case, the biological secretion collected is earwax fluid.

[0021] The storage and discharge tube has a distal end and a proximal end. As used herein, the term “distal end” means the end that is away from the operator of the device and facing the lumen into which the device is inserted. Thus, the AM element will be discharged from the tube at the distal end or distal portion of the tube. Thus, as used herein, the term “proximal end” means the opposite end of the tube, i.e., the end that is facing towards the operator of the device and away from the lumen into which the device is inserted. Thus, the proximal end of the tube is closer to the operator of the device than the distal end of the tube.

[0022] The tube is configured to house and release AM elements. The AM elements are housed within the internal space of the tube. After the tube is inserted into a lumen, the AM elements are released from the tube. The AM elements are released from the distal end or distal end portion of the tube. The release of the AM elements is mediated by a release element. The release element is supported so as to be slidable relative to the tube along its longitudinal axis. By releasing the AM elements from the tube, the AM elements are deposited at a target location within the lumen.

[0023] The AM element is intended to be housed within the tube in an essentially linear, i.e., essentially straight shape, preferably without corners. The AM element is intended to be bent only once, i.e., when the AM element is released from the tube. This will be further explained in connection with the following description of the deflection means.

[0024] AM elements may not extend along the entire longitudinal extension direction of the internal space of the tube. The tube may have a considerably larger longitudinal extension compared to the longitudinal extension of the AM elements. In this case, the AM elements are discharged from the distal end or distal end portion of the tube, and are therefore preferably housed toward the distal end or distal end portion of the tube.

[0025] The tube may be basically straight, or it may have a slight curve at its proximal end. If the tube has a curve and the AM element is intended to be positioned in the upper part of the nasal cavity to collect nasal secretions located in the olfactory cleft, the curve of the tube is configured to face toward the septum (i.e., inward) during insertion of the tube into the nasal cavity. In other words, the proximal end of the tube is curved toward the septum. Such a curve facilitates the correct positioning of the tube, particularly by facilitating the correct insertion path of the tube along the septum toward the upper part of the nasal cavity. Specifically, the curve prevents deviation from the correct insertion path laterally. If the tube has curvature at its proximal end, the angle β between the septum and the proximal end of the tube is preferably 45° or less, more preferably 30° or less, even more preferably between 5° and 30°, and even more preferably about 20°. It is preferable that the curve at the proximal end of the tube does not cause the AM element housed within the tube to bend within the tube. This can be achieved, for example, by housing the AM element in the distal end of the tube.

[0026] The application device allows for the targeted and standardized positioning of AM elements within the lumen, resulting in the standardized collection of secretions. This significantly reduces variability in the type and amount of secretions absorbed by the AM elements compared to other methods of positioning, such as manual placement.

[0027] The design of the application device allows for targeted, simple, and reliable positioning of AM elements within the cavity. Consequently, the application device design minimizes the risk of patient injury during AM element positioning, thereby increasing patient comfort and reducing variability in collected secretions due to injuries or irritations (such as tissue or blood traces). This is particularly relevant when positioning AM elements in the olfactory cleft, which is highly sensitive, typically above the inferior and middle turbinates, laterally to the superior turbinate, and beneath the olfactory fibers. In some patients, due to the anatomical structure of the nasal cavity, the olfactory cleft may be located laterally to the middle turbinate rather than laterally to the superior turbinate.

[0028] The effect of ensuring the AM element is positioned reliably while minimizing the risk of injury is primarily achieved by bending and / or deflecting the AM element when it is released from the tube. The deflection means can bend the AM element away from the longitudinal axis of the tube when it is released from the tube. Thus, the AM element has a curve while being released from the tube. The deflection means can bend the AM element away from the longitudinal axis of the tube in a predetermined direction. This ensures that the AM element is reliably positioned at the intended target location within the lumen. By bending and / or deflecting the AM element when it is released from the tube, contact and contact force between the AM element and the mucosa (or other anatomical boundary) within the lumen can be minimized. This can improve patient safety and comfort.

[0029] When AM elements are released from the tube, each element that bends and / or deflects can be considered a deflection-stopping mechanism. Bending or deflection results in an AM element release direction inclined by an angle α > 0° with respect to the longitudinal axis of the tube.

[0030] When positioning the AM element in the upper part of the nasal cavity to collect nasal secretions located in the olfactory cleft, the deflection means causes the AM element to bend in the cranial and medial anatomical directions.

[0031] The deflection mechanism allows the application device to position the AM element in the upper part of the nasal cavity to collect nasal secretions located in the olfactory cleft. To reach this region of the nasal cavity, an AM element that is not bent during release, i.e., released in a straight or linear manner aligned with the long axis of the tube, would be unsuitable. Due to the anatomical structure of the nasal cavity, a linear form during release may be suitable for reaching the lower or middle part of the nasal cavity, but may not be suitable for reaching the upper part where the olfactory cleft is located.

[0032] Depending on the degree of deflection during the release of the AM element, the application apparatus of the present invention may also be used to position the AM element in the lower or central part of the nasal cavity.

[0033] The emission direction of the AM element is tilted by an angle α > 0° with respect to the longitudinal axis of the tube. The angle α is predetermined by the design of the coating apparatus, particularly by the design of the deflection mechanism.

[0034] To position the AM element in the upper part of the nasal cavity, the angle α is preferably 0° to 50° or less, and more preferably 20° to 45°.

[0035] To position the AM element in the center of the nasal cavity, the angle α is preferably greater than 0° and less than or equal to 30°, and preferably between 5° and 15°.

[0036] To position the AM element in the upper part of the nasal cavity, the angle α is preferably greater than 0° and less than or equal to 20°.

[0037] Depending on the individual anatomical structure of a given patient's nasal cavity, the operator of the dispensing device may adjust the positioning of the tube so that the AM element, once released from the tube, reliably reaches its intended target location. For example, the operator may select a steeper insertion angle of the tube into the cavity.

[0038] To easily adapt the positioning of the tube to the individual anatomical structure of each patient, it is preferable that the distal end of the tube be easily bendable.

[0039] The deflection mechanism does not require the distal end or distal portion of the tube to be positioned to directly face the intended target location of the AM element. Rather, it is possible to stop the insertion of the tube before it directly faces the target location at a position and distance suitable for positioning the AM element at the target location upon discharge from the tube.

[0040] With regard to patient safety, in addition to deflection measures, the risk of injury is further reduced, preferably by at least one stop lands protruding from the outer surface of the tube. The stop lands limit the insertion depth of the tube into the lumen. Another preferred means to minimize the risk of injury is to select the material of the tube such that the deformability of the tube at its distal end is greater than that at its proximal end. The distal end of the tube is preferably made of a flexible, bendable material such as rubber. These optional means are particularly useful in minimizing the risk of injuring the base of the skull when the AM element is positioned within the olfactory cleft.

[0041] A further advantage of the application device is that secretions absorbed by the AM element after release from the tube are absorbed exclusively from the intended target location of the AM element and are therefore highly pure. The AM element is protected from any unintended contact within the cavity by being contained within the tube along its entire path to reach a suitable location for positioning the AM element at its intended target location, e.g., in the upper part of the nasal cavity, during insertion into the cavity. Therefore, there is no risk of contamination of the absorbent matrix of the AM element by secretions or fluids absorbed during insertion of the AM element into the cavity. Similarly, especially when the tube is inserted into the nasal cavity through each nostril, there is no risk of dilution of secretions by fluids absorbed during insertion of the AM element into the nasal cavity, or of the secretions being contaminated with bacteria or dust. For example, if the AM element is positioned in the olfactory cleft by hand rather than using the application device of the present invention, contamination and dilution of the target secretions can easily occur by wiping the AM element along the mucous membrane of the lower part of the nasal cavity during its insertion into the nose. This type of contamination and dilution is the main cause of variation in the type and amount of secretions absorbed by the AM element. The degree of such contamination and dilution also depends on the experience of the examiner collecting the secretions. By using a dispensing device to position the AM element at its intended target location, undesirable contamination and dilution of the secretions collected by the AM element can be avoided. As a result, the quality of the collected secretions is much better. Consequently, the reproducibility of secretion collection is also improved. This contributes to collecting secretions in a standardized manner.

[0042] By avoiding undesirable contamination and dilution of secretions collected using AM elements, the sensitivity of subsequent analysis of the secretions is also improved.

[0043] By residing within the tube during insertion into the lumen, the AM element is protected from unintended contact within the lumen, thus eliminating the risk of incomplete absorption of secretions at the intended target site. Such incomplete absorption can be caused by fluids absorbed during insertion of the AM element into the lumen, reducing the AM element's absorption capacity at the target site.

[0044] During the removal of AM elements from the lumen after secretion collection, undesirable contamination and dilution of the collected secretions by AM elements are unlikely to occur because the absorption capacity of AM elements is significantly reduced at this point.

[0045] In a preferred embodiment, the dimensions of the AM element are selected such that the absorbent capacity of the AM element approaches zero after collecting the intended secretions over the intended collection time. This further avoids undesirable contamination and dilution of the secretions collected by the AM element while removing the AM element from the lumen.

[0046] By using a coating device to position the AM element at its intended target location, the collected secretions are extremely pure, undiluted, and clearly defined. This cannot be achieved with known sampling techniques.

[0047] The AM element is not attached to the tube, the discharge element, or the deflection means. In other words, the AM element is not attached to any other part of the dispensing apparatus of the present invention. This makes it possible to leave the AM element in the cavity, particularly in the nasal cavity, while simultaneously eliminating the need to leave the storage discharge tube in the nasal cavity. Therefore, after discharging the AM element from the tube, the tube can be removed from the cavity while the AM element remains in the cavity.

[0048] In one embodiment, the tube can then be refilled with a second AM element to position the second AM element in the patient's second nostril after positioning the first AM element in the patient's first nostril, for example by using an application device, for further use.

[0049] However, in a preferred embodiment, the application device of the present invention is a disposable device. For practical and hygienic reasons, it is preferable that the application device be a disposable product. Therefore, the first application device is used to position the first AM element in the first nasal cavity through the patient's first nostril, and the second application device is used to position the second AM element in the second nasal cavity through the patient's second nostril. After collection, the secretions from the first nasal cavity and the secretions from the second nasal cavity may be combined for further analysis.

[0050] By removing the tube from the cavity after the AM element has been released and deposited at its target location, it becomes possible to leave the AM element in the cavity for a relatively long period, for example, 15 minutes, without causing discomfort to the patient due to the tube. Therefore, it becomes possible to extend the collection time compared to situations where the tube also needs to remain in the cavity. This is a significant advantage of the application apparatus of the present invention, especially when the AM element is used to collect nasal secretions from the olfactory cleft. Assuming that the amount of nasal secretions is very small, a long collection time, for example 15 minutes, corresponding to the long residence time of the AM element in the cavity, may be required to collect a sufficient amount of nasal secretions for subsequent analysis. Such a long collection time can only be achieved by removing the tube from the nasal cavity while the AM element remains in the nasal cavity. Inserting the tube into the nose would present a constant risk of the tube causing injury to the base of the skull and / or bleeding of the nasal mucosa. Furthermore, because the nasal cavity is narrow and particularly sensitive in the area of ​​the olfactory cleft, the tube would cause persistent irritation to the nose. Therefore, having the tube in the nose for the entire time secretions are being collected is uncomfortable for the patient. Furthermore, due to the permanent irritation caused by the tube, patients are unable to remain seated for the required collection time without anesthesia.

[0051] For example, long collection times, such as 15 minutes, cannot be achieved with known sampling techniques, especially when collecting nasal secretions from the upper part of the nasal cavity.

[0052] When using the coating apparatus of the present invention, there is no time limit on the collection period.

[0053] In summary, the application device of the present invention has improved characteristics in at least three embodiments. The first embodiment relates to the positioning of AM elements, and therefore to the positioning of AM elements within the cavity. As described above, the application device makes it possible to position AM elements within the cavity in a targeted and standardized manner, and subsequently to position secretions in a standardized manner. Also as described above, the application device is particularly suitable for positioning AM elements in the upper part of the nasal cavity, more specifically in the olfactory cleft. The second embodiment relates to the purity of the collected secretions. As described above, the collected secretions are very pure, undiluted, and clearly defined. The third embodiment relates to the time of secretion collection. As described above, there is no time limit on the collection period.

[0054] In a preferred embodiment, a first dispensing device is provided for positioning a first AM element in the right nostril, and a second dispensing device is provided for positioning a second AM element in the left nostril. The first and second dispensing devices are preferably mirror images of each other. For example, when comparing the first and second dispensing devices, the positions of rotation marks provided on the outer surface of the tube or visible from the outside of the tube are preferably mirror images of each other. The rotation marks will be described in more detail below. If the tube has a curvature toward the septum at the proximal end of the tube, the curvature may also be mirror images of each other when comparing the first and second dispensing devices.

[0055] The dispensing device is preferably designed to be easily bent and compressed without causing excessive contact force when the device comes into contact with the mucous membrane in the lumen. This improves patient safety and comfort. Therefore, the retractable discharge tube is preferably made from a flexible material that can be easily deformed. For example, the retractable discharge tube can be made from soft plastic or soft silicone. The material is also biocompatible and generally selected to be suitable for medical devices.

[0056] In a preferred embodiment, the discharge opening of the tube is closed by a closure, at least in the pre-use stage of the apparatus. The discharge opening is preferably closed by the closure until the AM element discharge process. The closure further protects the AM element, particularly the distal end of the AM element, from potential contamination through the discharge opening. The discharge opening may be located at the distal end of the tube or on the side wall of the tube in the distal end portion of the tube.

[0057] In a preferred embodiment, the closure and at least the distal end portion of the AM element are configured to release the closure by pushing the distal end of the AM element forward when the AM element is released from the tube. The closure protects the AM element from potential contamination until it is released from the tube. In particular, the closure protects the AM element from potential contamination during insertion into the lumen.

[0058] The closure may be a film attached to the discharge opening. The film may be attached, for example, by gluing or welding. The film, for example, a thin plastic sheet, must remain connected to the containment discharge tube after the AM element has been pressed through the film, so that the film is not lost within the cavity.

[0059] In a preferred embodiment, the closure is a tongue closure comprising multiple tongues, the multiple tongues of which may form tapered tips. The advantage of closing the discharge opening of the tube with a tongue closure is that the tongue closure can be opened by a pressing force applied only to the AM element. This is due to the flexibility of the tongues of the tongue closure. No additional opening means are required to open the closure.

[0060] In a preferred embodiment, the dispensing device further comprises at least one shroud means located within the transition region of the tube and deflection means. The transition region is the area where contact between the retractable discharge tube and the nasal mucosa is most likely to occur. By providing the shroud means, contact and / or contact force between the retractable discharge tube and the anatomical boundary of the cavity, for example, contact and / or contact force between the tube and the nasal mucosa of the nasal cavity can be further minimized. The shroud means also functions as a damper means for softening possible contact between the retractable discharge tube and the nasal mucosa. This further improves patient comfort during insertion of the device and discharge of the AM element, and more importantly, reduces the risk of injury to the patient. Similarly, it further facilitates the patient's acceptance of the procedure.

[0061] In a preferred embodiment, the shroud means comprises at least one cushioning element arranged along the outer circumferential surface of the transition region. Preferably, the shroud means comprises a plurality of cushioning elements arranged along the outer circumferential surface of the transition region. By forming the shroud means with one or more cushioning elements arranged along the outer circumferential surface of the transition region, potential contact between the storage-release tube and the nasal mucosa can be softened.

[0062] The cushioning elements may be formed as ring-shaped elements surrounding the outer surface. Alternatively, multiple single cushioning elements may be arranged along the outer surface. The cushioning elements are arranged in a position on the application device where they can come into contact with the anatomical boundaries of cavities such as the nasal mucosa of the nasal cavity. Ring-shaped elements or a ring-shaped arrangement of multiple cushioning elements are preferred because they allow the application device to be used in both the left and right nasal cavities.

[0063] In a preferred embodiment, the retractable discharge tube is at least partially coated with a soft material that acts as a damping means to soften possible contact between the retractable discharge tube and the nasal mucosa.

[0064] In a preferred embodiment, the dispensing device further includes a spreader device having deploying arm means, the dispensing device being attachable to one of the deploying arm means and thereby being organized in the gap between the deploying arm means. The deploying arm means is preferably connected to or attached to the dispensing device. The deploying arm means ensure a sufficient gap in the opening of the cavity, which facilitates the insertion of the dispensing device into the cavity. This is particularly relevant to the nasal cavity, which is often quite narrow. The deploying arm means may be configured to open the nose vertically by pushing the nostrils upward.

[0065] In a preferred embodiment, a scale is provided on the tube along its longitudinal direction, indicating the insertion depth of the tube into a body cavity of a human or animal. The scale is located within a suitable area of ​​the retractable discharge tube. Compared to the visible boundary or edge of the target cavity, the scale provides information regarding the insertion depth of the dispensing device into the cavity. This allows the operator to easily detect the insertion depth of the tube. In this way, the tube can be easily and controllly inserted to an insertion depth suitable for positioning the AM element. Controlling the insertion also reduces the risk of injury to the patient.

[0066] In a preferred embodiment, the tube is provided with at least one stop land protruding from its outer surface, the stop land being a ring land or plate-shaped land protruding from the outer surface near the proximal end of the tube. The stop land limits the insertion depth of the tube into the lumen, thereby reducing the risk of injury to the patient.

[0067] In a preferred embodiment, at least one stop land is organized near the scale.

[0068] In a preferred embodiment, the deflection means is formed by an extension wall portion of the tube that protrudes from the distal end of the tube, is inclined with respect to the longitudinal axis, and faces toward the longitudinal axis. Thus, the extension wall portion of the tube protrudes from one side of the distal end of the tube and curves inward toward the longitudinal axis of the tube. The extension wall portion may also be called an extension end wall portion. The extension wall portion is a simple method of forming and providing the deflection means. It can also be easily incorporated into the tube during the manufacture of the tube. The extension wall portion is preferably formed integrally with the retraction tube so as not to risk the deflection means becoming loose in the lumen.

[0069] In a more preferred embodiment, the extension wall portion is inclined with respect to the longitudinal axis and extends beyond it toward the longitudinal axis of the tube. In other words, the extension wall portion curves inward toward the longitudinal axis of the tube and extends beyond the longitudinal axis.

[0070] In a preferred embodiment, a tongue closure is provided, comprising multiple tongues that form a tapered distal end, constituting the distal end of the tube. The advantage of closing the distal end of the tube with a tongue closure is that the tongue closure can be opened by a pressing force applied only to the AM element. This is due to the flexibility of the tongues of the tongue closure. No additional opening means are required to open the closure. Closing the distal end of the tube also protects the AM element from potential contamination until it is released from the tube.

[0071] In a preferred embodiment, at least one of the tongues of the tongue closure has higher bending stiffness away from the longitudinal axis compared to at least one other tongue, thereby forming a deflection means. The tongue closure allows for the incorporation of the deflection means within the closure by including at least one tongue that is less flexible than the other tongues, i.e., by including at least one tongue that is more bending stiff than the other tongues. Thus, the AM element is deflected during its release through the opening at the distal end of the tube.

[0072] In another preferred embodiment, the deflection means is a discharge opening located in the side wall of the tube at the distal end of the tube. The discharge opening is configured through which the AM element passes during the discharge process of the AM element. Because the discharge opening is located in the side wall of the tube, pushing the AM element through the discharge opening causes the AM element to bend and thus deflect from the longitudinal axis of the tube. Because the discharge opening is located in the side wall of the tube, the distal end of the tube is closed. This reduces the risk of undesirable contamination of the AM element until it is discharged from the tube. In this embodiment, the tube preferably has a rounded distal end, which reduces the risk of injury to the patient during insertion of the tube into the lumen. The tube is even more preferably tapered toward its distal end, which allows for easier and more precise access to the patient's olfactory cleft.

[0073] The discharge opening is preferably kept closed until the AM element is released. This protects the AM element from potential contamination until it is released from the tube.

[0074] The discharge opening is preferably closed by a tongue closure having multiple tongues. The advantage of closing the discharge opening of the tube with a tongue closure is that the tongue closure can be opened by a pressing force applied only to the AM element. This is due to the flexibility of the tongues of the tongue closure. No additional opening means are required to open the closure. Closing the discharge opening of the tube also protects the AM element from potential contamination until the AM element is discharged from the tube.

[0075] In another embodiment, the discharge opening is a through-hole located in the side wall of the tube at the distal end of the tube.

[0076] In a preferred embodiment, the discharge element is a piston-type rod having a piston portion slidably mounted within the tube. By forming the discharge element as a piston-type rod, it becomes possible to push and discharge the AM element.

[0077] In another preferred embodiment, the release element is a push rod that reaches through a longitudinal side slot of the tube, and the push rod is slidably movable along the slot. Moving the push rod along the slot moves the AM element forward, and an extruding force is applied to the AM element. This leads to the AM element being released. Since there is no risk of the AM element twisting when using the push rod, a flexible AM ​​element can be used.

[0078] In a preferred embodiment, the AM element has a ribbon or leash at its proximal end to remove the AM element from its target location within the lumen. The ribbon or leash facilitates the removal of the AM element from the lumen. Advantageously, the removal can be performed without contact with the absorbent matrix itself. The ribbon or leash makes the removal process smoother and easier, thereby improving patient comfort.

[0079] The ribbon or leash may be attached to the AM element at its proximal end, or within the region of the proximal end of the AM element.

[0080] In one embodiment, the ribbon or leash is deployed by removing the tube from the lumen after the AM element has been released. The ribbon or leash deploys along the tube's removal path. This ensures that the ribbon or leash extends to the entrance of the lumen, allowing the AM element to be removed from the lumen by pulling the ribbon or leash. The tube's removal path is generally the same path used for insertion into the lumen.

[0081] In another embodiment, the ribbon or leash exits the AM element through the discharge opening and then travels essentially along the outside of the tube toward the proximal end of the tube. The ribbon or leash extends beyond the proximal end of the tube and is preferably held by a notch located on the outer surface of the dispensing device in the region of the proximal end of the dispensing device. In this embodiment, when the AM element is discharged from the tube, the ribbon or leash is already outside the tube and does not need to pass through the tube when the tube is removed from the lumen.

[0082] In a preferred embodiment, radiopaque markers are attached to the AM element, for example, in the form of stripes or dots. The radiopaque markers facilitate detection if the AM element is lost within the cavity.

[0083] In a preferred embodiment, the coating apparatus includes illumination means capable of illuminating a cavity in a human or animal body during the insertion process of the coating apparatus and / or the release process of the AM element. Illuminating the cavity facilitates accurate and reproducible positioning of the coating apparatus and monitoring of the release of the AM element. In this way, the illumination means also facilitates accurate and reproducible positioning of the AM element at its intended target position within the cavity.

[0084] In a preferred embodiment, at least the tube is tapered along at least a portion of its longitudinal dimension, and the tapering makes it tapered towards the distal end of the tube. Thus, the circumference of the proximal end of the tube is longer than the circumference of the distal end of the tube. By tapering the tube and / or the entire dispensing device toward its distal end, the process of inserting the dispensing device into the lumen is facilitated, especially when the lumen is narrow. For example, when positioning an AM element in the olfactory cleft region of the nasal cavity, the anatomical perimeter through which the dispensing device must pass narrows toward the target location of the AM element. By tapering at least the tube toward its distal end, it is easier to find a suitable route for inserting the device while minimizing the risk of patient injury and improving patient comfort.

[0085] In a preferred embodiment, a latch mechanism is provided at a latch position, from which the AM element is released and can be latched. The latch mechanism provides tactile and acoustic feedback to the operator of the dispensing device, indicating that the AM element has been fully released. This improves patient safety, especially when the operator cannot visually confirm the complete release of the AM element. If the release element is a piston-type rod having a piston portion slidably mounted within a tube, it is preferable that the AM element is released in such a way that the piston portion of the release element can be latched. When the AM element is fully released, the piston portion may engage, for example, with a recess organized within the tube, and this engagement is accompanied by an acoustic signal such as a click (acoustic feedback to the operator). After engaging with the recess, the piston portion can no longer be moved (tactile feedback to the operator). This also ensures that the push portion cannot move any further forward, thereby improving patient safety.

[0086] In a preferred embodiment, the inner surface of the tube is provided with threads protruding from the inner surface, which can act with the AM element to rotate the AM element along its longitudinal axis during the AM element ejection process. The internal threads, or alternatively, internal serpentine ribs, facilitate the rotation of the AM element around its longitudinal axis during ejection from the tube, thereby facilitating the positioning of the AM element by rotating it like a drill. Rotating the AM element facilitates positioning the AM element at its intended target position.

[0087] In a preferred embodiment, the first portion of the tube has greater deformability than the second portion of the tube, the first portion is intended to be inserted into a lumen, and the second portion is not intended to be inserted into a lumen. Accordingly, in a preferred embodiment, the deformability of the tube at its distal end is higher than that at its proximal end. The different levels of deformability make the insertion process of the dispensing device more comfortable for both the device operator and the patient.

[0088] In a preferred embodiment, the wing-shaped plate element protrudes from the outer surface of the tube in the region of the proximal end of the tube. The plate element allows the operator to administer / measure the application force applied to the release element in a more precise manner. In this way, the rate of the AM element release process can be controlled more easily. This reduces the risk of patient discomfort that may be caused by the rapid release of the AM element.

[0089] If the application device is intended to collect nasal secretions, the wing-shaped plate element preferably has an overall dimension larger than the opening of the nostril, and as a result, the wing-shaped plate element also functions as a stopping means to limit the insertion depth of the tube into the nasal cavity. This reduces the risk of patient injury, such as a skull base injury.

[0090] In a preferred embodiment, one or more rotation marks are provided on the outer surface of the tube or visible from the outside of the tube, and at least one rotation mark is positioned such that when the device is correctly positioned relative to its axis of rotation in the nasal cavity, at least one rotation mark is configured to face the forehead, chin, or nasal septum. The rotation marks allow the operator of the device to control the correct positioning of the device in the nasal cavity before initiating the AM element release process.

[0091] In a preferred embodiment, the AM element has an elongated shape.

[0092] In preferred embodiments, the AM element has a circular, elliptical, or polygonal cross-sectional shape, and in the case of a polygonal cross-sectional shape, it has rounded edges. A polygonal cross-sectional shape with rounded edges reduces the risk of the AM element curling up. It also reduces the risk of sustaining any kind of injury during the discharge and / or absorption of the AM element from the tube. A preferred polygonal cross-sectional shape with rounded edges is a triangular cross-sectional shape with rounded edges.

[0093] When a screw thread protruding from the inner circumference of the tube is provided on the tube, a polygonal cross-sectional AM element is preferable because the screw thread makes it easier to grip. This improves the reliability of the rotation of the AM element during the AM element release process.

[0094] In a preferred embodiment, the AM element has a constant cross-sectional shape along its longitudinal axis or is tapered toward its distal end. In both cases, the distal and proximal ends of the AM element are preferably rounded. The tapered design of the distal end of the AM element facilitates positioning the AM element at its intended target location. It also reduces the risk of injury of any kind during the discharge of the AM element from the tube.

[0095] In a preferred embodiment, the AM element is made from an elastic, compressible material. The material may be a fibrous matrix. The material needs to be suitable for collecting secretions for subsequent analysis. Examples of preferred materials include nylon flock, cellulose, cotton, natural sponge materials (such as sponge materials made from natural cellulose), synthetic sponge materials (such as sponge materials made from polyvinyl alcohol, hydroxylated polyvinyl acetate and / or polyurethane), and / or foamed materials (such as foamed materials made from fibrous polymers).

[0096] In a preferred embodiment, the AM element has a length of about 2 cm to 6 cm, preferably about 3 cm to 6 cm, more preferably about 4 cm to 6 cm, and a diameter of about 2 mm to 6 mm, preferably about 2 mm. As described above, the AM element is preferably tapered toward its distal end. In this case, the minimum diameter of the AM element at the distal end is preferably about 2 mm, and the maximum diameter of the AM element at the proximal end is preferably about 3 mm to 6 mm.

[0097] In a preferred embodiment, the AM element is at least partially torsionally rigid. For this purpose, the AM element preferably has a spine element along at least a portion of its longitudinal dimension, which can be bent within an estimated range of the pressing force applied to the AM element during discharge from the tube, but cannot twist. The spine element improves the torsional rigidity of the AM element while maintaining the flexibility of the AM element along its extending direction. The spine element can more precisely define and make predictable the movement of the AM element during the discharge process. The spine element further helps to prevent the AM element from agglomerating or clumping together or curling up within the containment discharge tube, caused by the pressing force applied to the AM element during the discharge process. This facilitates positioning the AM element in an extended form at its target position. The spine element can be organized, for example, within the AM element (e.g., at the center of the AM element) or on one or more sides of the AM element. In the case of a polygonal AM element, the spine element may be organized, for example, on each polygonal side.

[0098] Alternatively, the AM element may have torsional rigidity due to the rigidity of the material from which it is fabricated. As mentioned above, the material is preferably a compressible material, and rigidity can be generated by the compression of the material.

[0099] In a preferred embodiment, the compressible material of the AM element is compressed upon contact with a fluid such as biological secretions, thereby increasing its dimensions and decreasing its rigidity. This decrease in rigidity improves patient comfort during collection time and the AM element removal process.

[0100] In a preferred embodiment, as an additional safety protection for the patient, the AM element is surrounded by a thin, stretchable mesh or layer to prevent any residue of the AM element from remaining in the lumen when the AM element is removed from the lumen. The mesh or layer ensures the physical integrity of the AM element. The mesh or layer is designed not to significantly reduce the absorption surface of the AM element.

[0101] In a second aspect, the present invention relates to a collection kit applicable for collecting biological secretions from the cavities of a human or animal, the collection kit comprising a dispensing device of the present invention, and the collection kit further comprising a container arrangement for storing AM elements after the collection of secretions.

[0102] The collection kit is preferably applicable for collecting nasal secretions, particularly nasal secretions from the area above the turbinate, and especially nasal secretions from the olfactory cleft.

[0103] The container configuration is preferably configured to fit into a centrifuge for centrifuging AM elements. Centrifugation of AM elements is an efficient method for recovering secretions from AM elements for further analysis. By providing a container configuration configured to fit into a centrifuge, the transfer step for transferring AM elements from a transport container to a centrifuge container is eliminated. Eliminating the transfer step saves time and materials and reduces the risk of sample contamination. It also reduces the risk of sample material loss.

[0104] In a preferred embodiment, the container arrangement comprises an inner container and an outer container, the inner container configured to receive AM elements after secretion collection, and having at least one opening so that the internal space of the inner container communicates with the internal space of the outer container. The inner container has a smaller diameter and a shorter length than the outer container, and as a result, the inner container is fully insertable into the outer container. Such a two-shell design of the container arrangement having an inner container (the smaller container) and an outer container (the larger container) facilitates further processing of the AM elements by centrifugation. The outer container is configured to fit into a centrifuge. During centrifugation, the AM elements remain in the internal space of the inner container, while the secretions separate from the AM elements and are located in the internal space of the outer container.

[0105] In a preferred embodiment, the inner container is insertable into the outer container of the container ensemble and lockable to the outer container of the container ensemble. In this way, a defined mechanical fixation of the inner container to the outer container is ensured.

[0106] Nasal secretions are preferably collected from the subject's left and right nostrils, respectively. After collection, the secretions from the left and right nostrils are preferably combined for further analysis. For this purpose, the container arrangement is preferably configured to store the two AM elements in the same container after secretion collection. In this case, the secretions collected by the two AM elements are easily combined, for example, by centrifugation, while the secretions from the two AM elements are recovered. In this case, it is not necessary to transfer any of the secretions from one container to the other in order to combine the secretions from the two AM elements. In this way, potential loss of secretion samples is prevented.

[0107] The containers used for organizing the analytes are generally made from materials that are low-binding and / or non-adsorbent to proteins and other analytes. These containers can be made from, for example, glass, polyethylene, or polypropylene.

[0108] In a third aspect, the present invention relates to the use of the application apparatus of the present invention, or the collection kit of the present invention for collecting nasal secretions, particularly for collecting nasal secretions from the olfactory cleft.

[0109] This disclosure further relates to an application device applicable for positioning absorbable matrix (AM) elements within a cavity in the body of a human or animal, wherein the application device is A containment and discharge tube having a distal end and a proximal end, configured to contain and discharge AM elements, • An emission element slidably supported relative to the tube along the longitudinal axis of the tube, configured to emit AM elements from the tube, • At least one deflection means organized at the distal end of the tube, which can bend the AM element away from the longitudinal axis of the tube when the AM element is ejected from the tube, It is equipped with.

[0110] The coating apparatus of this disclosure can be filled with AM elements. The AM elements are located within the internal space of the tube.

[0111] The features, advantages, and preferred embodiments of the coating apparatus of the present invention described above also apply to the coating apparatus of this disclosure.

[0112] The disclosure further relates to a dispensing kit applicable for positioning an AM element within a body cavity of a human or animal, the dispensing kit comprising a dispensing device of the disclosure and at least one AM element configured to be insertable into the internal space of a tube.

[0113] The Disclosure further relates to a collection kit applicable for collecting biological secretions from cavities of the body of a human or animal, comprising the dispensing apparatus of the Disclosure, wherein the collection kit further comprises a container arrangement for storing AM elements after the collection of secretions.

[0114] In a third aspect, the Disclosure relates to the use of the applicator of the Disclosure or the collection kit of the Disclosure for collecting nasal secretions.

[0115] The features, advantages, and preferred embodiments of the collection kit of the present invention described above also apply to the collection kit of the present disclosure. The same applies to the use of the coating apparatus or the collection kit of the present disclosure.

[0116] The present invention will now be described in more detail with reference to the accompanying drawings.

[0117] Figure 1 shows a perspective view of a human nose 1. The perspective view is shown in semi-transparent form. The human nose 1 has a left nostril 2 and a right nostril 3. Corresponding to nostrils 2 and 3 are the left nasal cavity 4 and the right nasal cavity 5. The nasal cavities 4 and 5 are separated by a nasal septum 6. The nasal cavities 4 and 5 are lined with mucus. At the upper end of the nasal cavities 4 and 5 is the cranial base 7, which separates the nasal cavities 4 and 5 from the internal space of the skull. In some parts, the cranial base 7 is made of very thin bone material and has a porous structure with multiple through-holes 8 through which olfactory fibers (not shown) protrude into the upper region of the nasal cavities 4 and 5.

[0118] The three nasal turbinates 9 are located opposite the nasal septum 6 within each nasal cavity 4, 5. To collect nasal secretions from the olfactory cleft located near the base of the skull 7, an absorbent matrix (AM) element 10 is positioned within the olfactory cleft, i.e., within the narrow space between the base of the skull 7, the nasal septum 6, and the uppermost nasal turbinate 9, just below the base of the skull 7, medial to the uppermost nasal turbinate 9. This region of the nasal cleft is difficult to reach from the nostrils 2, 3 by instruments or devices. The AM element 10 is positioned within the olfactory cleft by being released from an application device of the present invention (not shown in Figure 1). The application device has already been removed.

[0119] Assuming a very small amount of nasal secretions, it is necessary to increase the collection time, for example to 15 minutes, to collect a sufficient amount of nasal secretions for subsequent analysis, corresponding to the long residence time of the AM element 10 below the base of the skull 7.

[0120] The AM element 10 has a distal end 11 and a proximal end 12. The leash 13 is attached to the proximal end 12. The leash 13 allows the AM element 10 to be withdrawn from the absorption position shown in Figure 1, and removed from the nasal cavities 4 and 5 as it passes through the respective nostrils 2 and 3.

[0121] In the position of the AM element 10 shown in Figure 1, the distal portion of the AM element 10 is essentially organized horizontally below the base of the skull 7, and the proximal portion of the AM element 10 is curved approximately perpendicular to its distal portion. The proximal portion of the AM element 10 is positioned such that its proximal end 12 is essentially oriented toward the respective nostrils 2, 3.

[0122] Several embodiments of the coating apparatus of the present invention will be described here with reference to Figures 2A, 2B, 3A, 3B, and 4.

[0123] A first embodiment of the coating apparatus of the present invention will now be described with reference to Figures 2A and 2B.

[0124] The coating apparatus 100 according to the present invention has a storage and discharge tube 101, which is configured to house the AM element 10 within its internal space 102. The storage and discharge tube 101 has a distal end 103 and a proximal end 104. The storage and discharge tube 101 has a longitudinal axis L.

[0125] At its distal end 103, the storage and discharge tube 101 has a discharge opening 105, through which the AM element 10 can be pushed out of the internal space 102 by the discharge element 106. The discharge element 106 is a piston-type rod having a piston portion 107 and a push rod portion 108. The piston portion 107 is slidably mounted within the internal space 102 of the storage and discharge tube 101. The piston portion 107 is configured to act on the proximal end 12 of the AM element 10, thereby pushing the AM element 10 out of the storage and discharge tube 101 through the discharge opening 105. For example, the piston portion 107 is configured to transmit pressure to the AM element 10, thereby pushing the AM element 10 out of the storage and discharge tube 101 through the discharge opening 105.

[0126] The retraction tube 101 may have guide means for guiding and stabilizing at least one portion of the piston portion 107 and / or the pushrod portion 108. The guide means may be formed, for example, by a thick wall portion of the retraction tube 101, or by a guide rail protruding from the inner surface of the tube 101.

[0127] The coating apparatus 100 has a latch mechanism that provides tactile feedback to the operator of the coating apparatus 100 when the AM element 10 is fully released. For example, the storage and release tube 101 has a snap-in point (not shown) where the release element 106 snaps in when the piston portion 107 has fully pushed the AM element 10 out of the release opening 105. The latch mechanism may also provide acoustic feedback to the operator of the coating apparatus 100 when the AM element 10 is fully released.

[0128] The coating apparatus 100 further includes a safety mechanism (not shown) to prevent unintended movement of the release element 106 before the operator of the coating apparatus 100 intends to release the AM element 10, for example, during transport or unpacking of the coating apparatus 100.

[0129] The piston portion 107 is provided with an opening (not shown), through which the leash 13 can exit the internal space 102 of the storage / discharge tube 101 to the outside.

[0130] The discharge opening 105 is located in the region of the distal end 103 of the storage discharge tube 101. The wall portion 109 protrudes from the distal end 103 of the storage discharge tube 101. The wall portion 109 is formed to be inclined toward the longitudinal axis L with respect to the longitudinal axis L. In this way, the wall portion 109 acts as a deflection means 110, bending the AM element 10 away from the longitudinal axis L of the storage discharge tube 101 when the AM element 10 is discharged from the storage discharge tube 101.

[0131] The AM element 10 is not attached to the tube 101, the emission element 106, or the deflection means 110.

[0132] The dispensing device 100, which has an AM element 10 housed within a retractable discharge tube 101, can be inserted into one of the nasal cavities 4 or 5. During insertion, the retractable discharge tube 101 does not necessarily need to be bent. Once the retractable discharge tube 101 is inserted sufficiently far into one of the nasal cavities 4 or 5 with a protruding movement, the AM element 10 can be discharged by bending of the AM element 10 to a desired target area inside the uppermost nasal concha 9, below the base of the skull 7. The AM element 10 is bent by a deflection means 110, which is a protruding (expanded) wall portion 109 that bends the AM element 10 during discharge through the discharge opening 105.

[0133] To avoid damage to the mucous membrane, a shroud means 112 is provided in the transition region 111 of the containment / discharge tube 101 near its distal end 103. The shroud means 112 includes at least two cushioning elements 113, which are arranged along the outer circumferential surface 114 of the containment / discharge tube 101, and more specifically along the outer circumferential surface of the transition region 111.

[0134] Furthermore, the scale 115 is provided on the outer circumferential surface 114 of the containment / discharge tube 101, or at least in a location visible from the outside of the containment / discharge tube 101. The scale 115 is provided along the longitudinal direction 20 of the containment / discharge tube 101. The scale 115 indicates the insertion depth of the containment / discharge tube 101 into a body cavity of a human or animal, particularly into the nasal cavity 4, 5. The scale 115 helps the operator of the dispensing apparatus to estimate the position of the distal end 103 of the containment / discharge tube 101 for discharging the AM element 10 to the intended target location.

[0135] Furthermore, at least one plate element 116 may be provided at the proximal end 104 of the storage discharge tube 101. The plate element 116 protrudes radially outward from the outer circumferential surface 114 and acts as a support means for the operator to better hold the dispensing device 100 while positioning the AM element 10. Two opposing, protruding plate elements 116 can be formed as finger flanges that can be gripped by the operator's two fingers on the dispensing device 100, allowing the operator to push in the push rod portion 108 with their thumbs.

[0136] Furthermore, at least one rotation mark 117 may be provided on the outer surface of the retractable discharge tube 101, or at least visible from the outside of the retractable discharge tube 101, to facilitate precise positioning of the retractable discharge tube 101 within the nasal cavity 4, 5 along the rotation direction 21. The rotation mark 117 may be positioned to correspond to the opening direction of the discharge opening 105 and / or to the jaw and / or nasal septum 6 or another characteristic part of the human or animal body, which helps to precisely position the dispensing device 100 relative to the intended target location of the AM element 10.

[0137] Furthermore, the illumination device 118 may be incorporated at an appropriate position in the coating device 100 to illuminate cavities of a human or animal body, particularly the nasal cavities 4, 5, during the emission process of the AM element 10. Irradiating the cavities makes it even easier to precisely position the AM element 10 at its intended target location.

[0138] In Figure 2A, the coating apparatus 100 is shown with the AM element 10 in its retracted (retracted) position before its discharge, and with the AM element 10 in a partially discharged position, i.e., with the AM element 10 partially separated from the retraction tube 101 and thus passed through the discharge opening 105. In the state prior to the discharge of the AM element 10, the discharge opening 105 is preferably closed by a closure (not shown in Figure 2A) to avoid undesirable contamination of the AM element 10 as it passes through the discharge opening 105 during its insertion into the lumen. The closure may be a film (not shown) attached to the discharge opening 105 by gluing or welding. The closure is preferably configured to be pushed away or pushed open by the distal end 11 of the AM element 10 as the AM element 10 is pushed out of the retraction tube 101. The film, for example, a thin plastic sheet, needs to remain connected to the retraction tube 101 after the AM element 10 has been pushed through the film, so that the film is not lost in the lumen.

[0139] Furthermore, the storage and discharge tube 101 may be formed of a material that is more rigid towards the proximal end 104 and more flexible / deformable towards the distal end 103 in order to minimize damage to the mucosa. However, the deflection means 110 is at least rigid against bending in order to ensure the desired deflection of the AM element 10 away from the longitudinal axis L when the AM element 10 is discharged from the tube 101. For this purpose, the deflection means 110 may be made rigid against bending by being formed to increase the wall thickness. As an addition or alternative, the deflection means 110 may also be designed in a bowl shape, which is a shape that is more rigid against bending compared to a planar design and is therefore suitable for functioning as a deflection means 110.

[0140] Another alternative is to form the deflection means 110 from a material that has higher stiffness / resistance to bending compared to the stiffness of the AM element 10.

[0141] Figure 2B shows an enlarged view of detail X shown in Figure 2A. The deflection means 110 is formed by an extended wall portion 109 of the storage and discharge tube 101 that protrudes from the distal end 103 of the storage and discharge tube 101 and is inclined toward the longitudinal axis L with respect to the longitudinal axis L.

[0142] It should be understood that each element that generates the emission direction 22 of the AM element 10, which is inclined at an angle α>0° with respect to the longitudinal axis L, can be considered as a deflection means 110.

[0143] Second and third embodiments of the coating apparatus 100 of the present invention will be described here with reference to Figures 3A, 3B, and 4. Elements having the same function and / or the same location will be referred to by the same reference number. To avoid unnecessary duplication, the embodiments in Figures 3A, 3B, and 4 will be described only in relation to the differences between the second / third embodiments and the first embodiment described above. The description of the function and / or features of the first embodiment described above is also applicable to the embodiments described later and will therefore not be repeated.

[0144] In the embodiment shown in Figure 3A, the closure is formed as a tongue closure 130 composed of a plurality of tongues 131. Each tongue 131 has a tongue tip 132 which is oriented toward the distal end 103 of the containment / discharge tube 101. The plurality of tongue tips 132 constitute the distal end 103 of the containment / discharge tube 101. At least one of the tongues 131 is designed to have greater rigidity against bending toward / from the longitudinal axis L of the containment / discharge tube 101 compared to the rigidity of the other tongues 131 against bending toward / from the longitudinal axis L of the containment / discharge tube 101.

[0145] One or more tongues 131 with high bending stiffness form deflection elements 110, as these tongues 131 are not bent, or bent to a smaller extent, by the protruding AM element 10 during its release. In other words, softer tongues 131, i.e., tongues 131 with low bending stiffness, bend away from the longitudinal axis L when the AM element 10 is pushed through the tongue closure 130 during its release, and therefore offer less resistance compared to the stiffer tongues 131. As a result, the AM element 10 is released from the storage / release tube 101 via the tongue closure 130 in a release direction 22 inclined at an angle α with respect to the longitudinal axis L. The release direction 22 also has an inclination angle (deflection angle) α > 0° with respect to the longitudinal axis L. The degree of deflection can be influenced by selecting the degree of difference between the bending stiffness of the stiffer tongues 131 and the bending stiffness of the softer tongues 131.

[0146] A further way in which the rigidity of the tongue portion 131 is influenced is based on the length of the tongue portion 131 along the longitudinal direction 20 of the tongue portion 131. Shorter tongue portions 131 typically have higher bending rigidity compared to longer tongue portions 131 made of the same material and with the same geometric shape.

[0147] Figure 3B shows a magnified view of detail Y shown in Figure 3A. The stiffer tongue portion 131' shown in Figure 3B is more rigid than the other tongue portions 131 which are bent away from each other by the AM element 10 protruding through the tongue closure 130, and thus forms the deflection means 110. Due to the difference in rigidity of the tongue portions 131 and 131', the AM element 10 is bent away from the longitudinal axis L of the storage / discharge tube 101 when it is discharged from the storage / discharge tube 101 by the movement of pushing the piston portion 107.

[0148] A further feature shown in Figure 3A is that the containment and discharge tube 101 is designed to be tapered along its longitudinal dimension, tapering towards the distal end 103 of the tube 101. This is also applicable to other embodiments described above or below.

[0149] Furthermore, the embodiment shown in Figure 3A includes a ring land 140 that serves as a stop land. The ring land 140 protrudes from the outer circumferential surface 114 of the storage / discharge tube 101 near the proximal end 104. The ring land 140 acts as a stop land that limits the insertion depth of the tube 101 into the lumen, preventing it from going too far and causing damage.

[0150] To support the flexibility of the AM element 10 and to avoid unintended twisting of the AM element 10, the AM element 10 may be provided with a spine element 15. The spine element 15 makes the AM element 10 more rigid against twisting, but can be easily bent by the deflection means 110, thereby allowing the AM element 10 to be smoothly pushed out of the storage / release tube 101.

[0151] A third embodiment of the coating apparatus 100 of the present invention will now be described with reference to Figure 4.

[0152] The third embodiment of the coating apparatus 100 comprises a spreader device 200 having a deploying arm means 201 connected to an operating arm 202. The operating arm 202 is joined by a pivot 203, and when the operating arm 202 is pressed together, the deploying arm means 201 move away from each other, thereby deploying an opening into which the deploying arm means 201 is inserted (for example, the openings of the nasal cavities 4, 5).

[0153] The embodiment of the coating apparatus 100 shown in Figure 4 further differs from the embodiment described above by having a longitudinal side slot 150 that extends at least partially in the longitudinal direction 20 of the storage discharge tube 101. A push rod 151 is slidably mounted within the longitudinal side slot 150, so that the push rod 151 can move along the longitudinal side slot 150 by pushing it back and forth.

[0154] One end of the push rod 151 extends into the internal space 102 of the storage / discharge tube 101 and acts on the AM element 10 stored within the storage / discharge tube 101. By pushing the push rod 151 toward the distal end 103 of the storage / discharge tube 101, the AM element 10 can be released from the storage / discharge tube 101.

[0155] The additional features described above (spreader device 200, push rod 151 acting on AM element 10 via longitudinal side slot 150) are also applicable to the embodiments described above.

[0156] Figure 5 shows an embodiment of the AM element 10 suitable for the coating apparatus 100 of the present invention. The AM element 10 has a distal end 11 and a proximal end 12. The leash 13 is attached to the proximal end 12. Furthermore, the AM element 10 has a centrally located spine element 15, thereby defining the longitudinal axis L of the AM element 10. S The AM element 10 is made from a material that can absorb secretions such as nasal secretions. A spine element 15 is provided to reinforce the material of the AM element 10 against twisting. The spine element 15 can be sufficiently bent by the deflection means 110 of the coating device 100, while having sufficient rigidity against twisting.

[0157] The spine element 15 may, alternatively, be positioned on one or more sides of the AM element, for example, on the sides of each polygon in the case of a polygonal AM element.

[0158] All of the embodiments described above may further include threads projecting inward from the inner circumferential surface of the storage / discharge tube 101. The threads (not shown) may have a helical winding along the inner circumferential surface and may interact with the AM element 10 during its discharge, thereby causing the AM element 10 to move along its longitudinal axis L during the discharge process of the AM element 10. S It is rotated in the rotational direction 21 along the direction. This means acts like a drill during movement to the desired target position, thus facilitating the ejection of the AM element 10.

[0159] Figure 6 shows a cross-sectional view of the container assembly 300 described herein. The container assembly 300 is suitable for safely storing and / or transporting AM elements after the collection of secretions 305. The container assembly 300 is part of an embodiment of the collection kit of the present invention, which comprises the application device 100 of the present invention and the container assembly 300 for storing AM elements 10 after the collection of secretions 305.

[0160] The container assembly 300 consists of an outer container 301 and an inner container 302. The inner container 302 has a smaller diameter and a shorter length compared to the outer container 301, and as a result, the inner container 302 can be fully inserted into the outer container 301. After the collection of secretions, the AM element 10 can preferably be stored in the inner container 302 having an inner diameter equal to or slightly larger than the outer diameter of the AM element 10.

[0161] In a preferred embodiment, the container assembly 300 comprises an inner container 302 and an outer container 301, the inner container 302 configured to receive the AM element 10 after the collection of secretions 305, and having at least one opening 303 so that the internal space of the inner container 302 communicates with the internal space of the outer container 301. Such a two-shell design of the container assembly 300 having an inner container (the smaller container) 302 and an outer container (the larger container) 301 facilitates further processing of the AM element 10 by centrifugation. The outer container 301 is configured to fit into a centrifuge. During centrifugation, the AM element 10 remains in the internal space of the inner container 302, while the secretions 305 separate from the AM element 10 and are located in the internal space of the outer container 301.

[0162] The inner container 302 has an opening 303 at its bottom. The inner container 302 is assembled inside the outer container 301. Both containers 301 and 302 may be closed by caps 304. The outer container 301 is preferably configured to fit into a rotating carousel of a centrifuge. By centrifuging the container assembly 300, which includes the AM element 10, the secretions 305 are separated from the AM element 10 and pass through the opening 303 by centrifugal force. Thus, the secretions 305 are collected at the bottom of the outer container 301 when the container assembly 300 is subjected to centrifugal force. [Explanation of symbols]

[0163] 1. Human nose 2. Left nostril 3. Right nostril 4 Left nasal cavity 5 Right nasal cavity 6 Nasal septum 7. Base of the skull 8 Through holes 9 Nasal turbinates 10 AM elements 11 (Distal end of AM element) 12 (Proximal end of AM element) 13 Leash 15 Spine Elements 20 Longitudinal direction 21 Direction of rotation 22 Discharge direction 100 Coating device 101 Storage and Discharge Tube 102 Interior space 103 Distal end 104 Proximal end 105 Discharge opening 106 Emission elements 107 Piston section 108 Push rod section 109 Wall section 110 Deflection means 111 Transition Area 112 Shroud means 113 Cushioning elements 114 Outer surface 115 divisions 116 Plate Elements 117 Rotation Mark 118 Lighting device 130 Tongue closure 131 Tongue 131' Highly rigid tongue 132 Tip of the tongue 140 Ringland 150 Longitudinal side slots 151 Pushrod 200 Spreader Unit 201 Deployment arm means 202 Actuating Arm 203 Pivot 300 container organization 301 Outer container 302 Inner container 303 Opening 304 Cap 305 Secretions L Longitudinal axis L S Longitudinal axis of AM element α angle

Claims

1. A coating device (100) applicable for positioning absorbable matrix (AM) elements (10) within a cavity in the body of a human or animal, wherein the coating device (100) - A storage and discharge tube (101) having a distal end (103) and a proximal end (104), wherein the tube (101) is configured to store and discharge the AM element (10), - The AM element (10) is housed within the internal space (102) of the tube (101), - The distal end (103) of the tube (101), or the discharge opening (105) located on the side wall of the tube (101) at the distal end portion of the tube (101), - A discharge element (106) is slidably supported on the tube (101) along the longitudinal axis (L) of the tube (101), and is configured to discharge the AM element (10) only from the discharge opening (105), - At least one deflection means (110) arranged at the distal end (103) of the tube (101), wherein the deflection means (110) can bend the AM element (10) away from the longitudinal axis (L) of the tube (101) when the AM element (10) is discharged from the discharge opening (105), Equipped with, The coating apparatus wherein the AM element (10) is not attached to any of the tube (101), the discharge element (106), or the deflection means (110).

2. The coating apparatus (100) according to claim 1, characterized in that the deflection means (110) is formed by an extended wall portion (109) of the tube (101) that protrudes from the distal end (103) of the tube (101) and is inclined toward the longitudinal axis (L) with respect to the longitudinal axis (L).

3. The coating apparatus (100) according to claim 1 or 2, characterized in that a tongue closure (130) is provided, which has a plurality of tongue portions (131) that form a tapered distal tip, and constitutes the distal end (103) of the tube (101).

4. The coating apparatus (100) according to claim 3, characterized in that at least one of the tongue portions (131) of the tongue closure (130) has a bending stiffness that increases away from the longitudinal axis (L) compared to at least one other tongue portion (131), thereby forming the deflection means (110).

5. The coating apparatus (100) according to claim 1 or 2, characterized in that the deflection means (110) is the discharge opening (105) located on the side wall of the tube (101) at the distal end portion of the tube (101).

6. The coating apparatus (100) according to any one of claims 1 to 5, characterized in that the discharge element (106) is a piston-type rod having a piston portion (107) slidably mounted inside the tube (101).

7. The coating apparatus (100) according to any one of claims 1 to 6, characterized in that the discharge element (106) is a push rod (151) that reaches through a longitudinal side slot (150) of the tube (101), and the push rod (151) is slidably movable along the slot (150).

8. The coating apparatus (100) according to any one of claims 1 to 7, characterized in that the discharge opening (105) of the tube is closed by a closure until the discharge process of the AM element (10).

9. The coating apparatus (100) according to any one of claims 1 to 8, characterized in that the AM element (10) has a ribbon or leash (13) at its proximal end (12) for removing the AM element (10) from its target position in the lumen.

10. The coating apparatus (100) according to claim 9, characterized in that the ribbon or leash (13) is deployed by removing the tube (101) from the cavity after the release of the AM element (10).

11. The coating apparatus (100) according to any one of claims 1 to 10, characterized in that at least the tube (101) is tapered along at least a portion of its longitudinal dimension, and the tapered shape is tapered toward the distal end (103) of the tube (101).

12. The inner circumferential surface of the tube (101) is provided with threads protruding from the inner circumferential surface, and the threads are used to move the AM element (10) along its longitudinal axis (L) during the discharge process of the AM element (10). Ｓ The coating apparatus (100) according to any one of claims 1 to 11, characterized in that it can act together with the AM element (10) to rotate along the )

13. The coating apparatus (100) according to any one of claims 1 to 12, characterized in that the wing-shaped plate element (116) protrudes from the outer circumferential surface (114) of the tube (101) in the region of the proximal end (104) of the tube (101).

14. A collection kit applicable for collecting biological secretions (305) from a body cavity of a human or animal, wherein the collection kit comprises a dispensing device (100) according to any one of claims 1 to 13, and the collection kit further comprises a container arrangement (300) for storing the AM elements (10) after the collection of the secretions (305).

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