Apparatus and method for collecting paranasal sinus nasal secretions

Abstract

The present invention provides an apparatus for collecting nasal secretion samples. 【Solution means】 The apparatus includes a sample collection member having a material for collecting a predetermined amount of nasal secretion samples. The apparatus further includes a handle and an elongated support member that extends between the handle and the sample collection member and supports the sample collection member. The apparatus is configured such that a user holding the handle contacts the sample collection member with the tissue at a target position within the nasal cavity, and the sample collection member collects a predetermined amount of nasal secretion samples at the target position.

Description

Technical Field

[0001] The present invention relates to an apparatus and method for collecting a nasal secretion sample for subsequent analysis. In particular, the present invention relates to an apparatus and method for accurate quantification of nasal secretion sampling. It should be understood that the present invention is particularly configured for use with nasal secretion samples, but the present invention may have broader applications with respect to other samples such as sputum.

Background Art

[0002] Inflammatory conditions of the paranasal sinuses are characterized by inflammation of the mucosa lining the inside of the nasal cavity (rhinitis), the paranasal sinuses (sinusitis), or both (rhinosinusitis).

[0003] The most common causes of sinusitis and rhinosinusitis are viral infections, bacterial infections, and allergic immune reactions such as hay fever. Rarely, in particular in individuals with a weakened immune system, fungal infections can also be the cause. Rhinitis can be classified into allergic rhinitis and non-allergic rhinitis. Allergic rhinitis is caused by allergens including dust, pollen, and mold, while non-allergic rhinitis can be caused by hormonal imbalances, environmental factors such as perfume and smoke, or the intake of medications such as beta blockers and ACE inhibitors.

[0004] Inflammation of the mucosa impedes the drainage of mucus, leading to mucosal stasis. Symptoms associated with sinusitis include swelling, a feeling of pressure, and pain in the paranasal sinuses. Generally, other symptoms associated with sinusitis and rhinosinusitis include sneezing, fever, headache, olfactory impairment, sore throat, mucus secretion, and cough.

[0005] These sinusitis conditions are common pathologies experienced by humans, but accurately diagnosing the causes of these conditions remains a challenge. When a patient exhibits symptoms related to these conditions, a general practitioner (GP) typically performs a physical examination of the face, ears, nose, throat, and neck to check for signs of swelling or congestion. If the symptoms are severe or persistent, the GP refers the patient to an ear, nose, and throat (ENT) specialist. The ENT specialist often examines the sinuses using specialized instruments such as endoscopes, rhinoscopes, and CT scanners. After the sinusitis condition is confirmed by physical examination, the cause of the condition is investigated.

[0006] If an allergen is suspected as the cause, medical experts perform allergy tests. If the cause is suspected to be a virus or bacteria, samples can be collected from the sinuses using sampling techniques for subsequent testing. There are two main categories of sinus secretion sampling techniques: bulk surface liquid collection and local surface liquid collection.

[0007] Bulk surface liquid collection includes forced expulsion of nasal secretions, nasal suction using a suction device, or nasal irrigation by spraying saline into the sinuses to collect samples in the liquid.

[0008] Local surface liquid collection involves the use of absorbent materials such as cotton wool and swab techniques for collecting sinus secretion samples. The most common method of collecting sinus secretion samples is oral pharyngeal and / or nasopharyngeal swabs. The swab is inserted into the patient's nose and directed in a direction parallel to the nose and the septum surface. As long as there are no obstacles in the nasal cavity, the swab continues to move in that direction until it reaches the nasopharynx. Once the swab reaches the nasopharynx, the swab is rotated to "scrape" the mucosa or the side of the nose is pinched to press the mucosa against the swab to make the sinus secretion absorbable. When the swab is removed from the patient's nose, it is stored in a culture medium or buffer solution and transported by cold chain transport for subsequent testing.

[0009] Nasopharyngeal swabs are invasive and uncomfortable for patients, and in many cases, trained medical personnel are required to perform the swabs. With these rubbing sampling techniques, there is a possibility that contaminants such as blood may be further mixed into the sample. Alternatively, samples are directly collected from the paranasal sinuses during nasal endoscopy. The diagnosis of sinusitis is confirmed by endoscopic observation of pus, and experts can directly insert a small cotton swab into abnormal mucosa. Endoscopic observation is also very invasive and uncomfortable, so patients may be required to endure it.

[0010] Generally, the examination of collected paranasal sinus samples is usually carried out in a laboratory, and it may take several days for medical personnel and patients to receive the results. The samples required for laboratory tests are small (usually 50 μl or less). Usually, this process involves diluting the sample with a reagent, and a specific final analysis target concentration is required to ensure accuracy. Any deviation from the final analysis target concentration may lead to an expanded error range, resulting in inaccurate results and insufficient diagnosis. As described above, sampling devices usually consist of absorbent materials for absorbing paranasal sinus secretions. However, existing sampling devices cannot collect a standardized sample volume that matches the amount required for accurate testing.

[0011] Furthermore, existing sampling devices often require rubbing sampling techniques where contaminants such as blood may be mixed into the sample, and the size and insertion depth of the sampler may not be suitable for the patient, resulting in discomfort.

Summary of the Invention

Problems to be Solved by the Invention

[0012] Therefore, means for collecting paranasal sinus secretion samples with volume control are required. Means for collecting paranasal sinus secretion samples within the minimum and maximum sample volumes are also required to ensure analysis accuracy. Furthermore, a non-rubbing technique for collecting biological samples of the paranasal sinuses used to determine the cause of a specific inflammatory condition is required.

[0013] Any description of background art throughout this specification should not be construed as an admission that any of the referenced documents or other materials are publicly available, known, or form part of common general knowledge.

[0014] Throughout the description and claims of this specification, the word "comprise", and variations of the word such as "comprising" and "comprises", are not intended to exclude other additives, steps or elements. **Means for Solving the Problem**

[0015] Thus, in one aspect, the present invention relates to an apparatus for collecting a nasal secretion sample. The apparatus comprises a sample collection member having a material for collecting a predetermined amount of nasal secretion sample, a handle, and an elongated support member extending between the handle and the sample collection member and supporting the sample collection member. The apparatus is configured such that a user holding the handle contacts the sample collection member with tissue at a target position within the nasal cavity, and the sample collection member collects a predetermined amount of nasal secretion sample at the target position.

[0016] Preferably, the housing of the apparatus encloses the sample collection member and the deployment mechanism within a central space.

[0017] Various embodiments of the apparatus are described and illustrated herein. In an embodiment, the sample collection member comprises an absorbent material. Preferably, the sample collection member has a plurality of strips of absorbent material having a plurality of snap points. In another embodiment, the sample collection member has a non-absorbent mesh strip having a void volume.

[0018] Preferably, the shape of the sample collection member enables volume control during sample collection. Preferably, the sample collection member collects a nasal secretion sample within a minimum and maximum sample volume. In some embodiments, the sample collection member has visual volume indicator means, such as a dye indicator.

[0019] Preferably, the sample collection member has an absorbent material configured to absorb nasal secretion samples. Preferably, the sample collection member is an absorbent material of a certain length and includes an absorbent material having one or more points for removing a part of the absorbent material in order to adjust a predetermined absorption capacity of the sample collection member. In an embodiment, the sample collection member includes a non-absorbent mesh strip having a void volume for holding nasal secretion samples.

[0020] Preferably, the sample collection member is configured to collect nasal secretion samples within a range of minimum and maximum volumes. In an embodiment, the sample collection member has a visual indicator that responds to the collection of a predetermined amount of nasal secretion by the sample collection member to provide a visual indication. In an embodiment, the visual volume indicator includes a dye indicator.

[0021] Preferably, the deployment mechanism includes a manually operable handle connected to the sample collection member, and the handle is movable relative to the housing so as to move the sample collection member between a storage position and a deployment position.

[0022] Preferably, the housing includes a surplus sample removal device for removing surplus samples on the surface of the sample collection member. In an embodiment, the surplus sample removal device includes a wiper that contacts the surface of the sample collection member when the sample collection member moves from the deployment position to the storage position to wipe off the surplus nasal secretion sample from the surface. Preferably, the wiper includes a wall surrounding an opening having a cross-section equal to the cross-section of the sample collection member that accommodates a sample of a predetermined amount or less. Thereby, when the sample collection member is pulled out through the opening, the surplus sample is wiped off from the surface of the sample collection member.

[0023] Preferably, in the deployed position, the sample collection member protrudes from the housing so as to contact the nasal secretion sample collected in the container or the absorbent sample collection material.

[0024] In an embodiment, the housing is configured to be inserted into a container containing a desiccant for drying the sample and maintaining a low relative humidity. Preferably, the housing is configured to be inserted into a container containing a preservative such as a buffer solution.

[0025] In an embodiment, the elongated support member has an opening at its distal end for accommodating a sample collection member therein. At least one side surface of the sample collection member is exposed to contact the nasal tissue.

[0026] Preferably, the elongated support member has, at its distal end, a pair of arms each supporting a respective sample collection member. The handle has a pair of gripping members at the proximal ends of the arms. When the gripping members are manually closed together, the sample collection members close together so as to be inserted into one or both nostrils simultaneously.

[0027] Preferably, the sample collection members are biased apart from each other such that when the gripping members are released with the sample collection members disposed within the nasal cavity, they contact the nasal tissue.

[0028] In an embodiment, the device further comprises one or more pivoting frame members disposed towards the distal end of the elongated support member. Each pivoting frame member supports at least a portion of one or more of the sample collection members.

[0029] Preferably, the pivoting frame members are arcuate and are pivotally connected to the elongated support member such that they are movable relative to each other between an open position and a closed position.

[0030] Preferably, the pivoting frame members are biased towards the open position, and the frame members and one or more sample collection members supported thereby contact the nasal tissue when inserted into the nasal cavity and are thereby biased towards the closed position.

[0031] In an embodiment, the device comprises one or more deployment frame members disposed toward the distal end of the elongated support member. Each deployment frame member supports at least a portion of one or more sample collection members.

[0032] Preferably, the deployment frame members have a non-operating state in which the frame members are closed together and a deployed state in which the frame members are opened so as to be spaced apart from each other.

[0033] Preferably, the frame members are flat in the non-operating state and arcuate in the deployed state, or vice versa.

[0034] In an embodiment, the device comprises a mechanism for selectively deploying or closing the frame members. The mechanism comprises a pair of manually operable handle members at the proximal end of the elongated support member. Closing the handle members manually towards each other opens the frame members, and opening the handle members manually closes the frame members, or vice versa.

[0035] Preferably, the frame members are biased towards the non-operating state. The frame members are movable to the deployed state when inserted into the nasal cavity, and the frame members and one or more sample collection members supported thereon contact the nasal tissue.

[0036] Embodiments of the device are used to collect an accurate amount of nasal secretion sample collected from a patient into a container or other suitable container, and can ensure analysis accuracy.

[0037] In another aspect, the present invention relates to a method for collecting a nasal secretion sample. The method includes deploying a sample collection member from a sample collection device into a patient's nasal cavity, collecting a predetermined amount of nasal secretion sample into the sample collection member, and storing the predetermined amount of nasal secretion sample in the sample collection device.

[0038] Preferably, the method includes wiping excess nasal secretion sample from the sample collection member when storing the sample collection member.

[0039] Preferably, the method includes contacting the deployed sample collection member with a nasal secretion sample collected within a container or an absorbent sample collection material.

[0040] Here, the present invention will be described in detail with reference to the preferred embodiments shown in the following accompanying drawings.

Brief Description of the Drawings

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DETAILED DESCRIPTION OF THE INVENTION

[0057] The present invention relates to an apparatus and method for collecting nasal secretion samples. Although several embodiments are described herein, the sample collection apparatus generally includes an apparatus for collecting a nasal secretion sample, the apparatus comprising a sample collection member having a material configured to collect a predetermined amount of nasal secretion sample, a handle, and an elongate support member extending between the handle and the sample collection member and supporting the sample collection member. The apparatus is configured such that a user holding the handle contacts the sample collection member against tissue at a target location within the nasal cavity, and the sample collection member collects a predetermined amount of nasal secretion sample at the target location.

[0058] FIGS. 1 - 6 show schematic views of an apparatus 1 for collecting nasal secretion samples according to an embodiment of the present invention. The apparatus 1 includes a housing 10 having elongate wall members 12, 14 extending between a proximal end 16 and a distal end 18. The wall members 12, 14 are spaced apart and arranged in parallel to define a central space 30. The central space 30 is elongate and extends from the proximal end 16 to the distal end 18 of the housing 10. The housing 10 is elliptical. The wall members 12, 14 are substantially linear and extend from a curved or arcuate proximal end 18 to taper-shaped ends 13, 15. The ends 13, 15 taper towards an end wall 20 at the distal end 18. The end wall 20 of the housing 10 has an opening 22.

[0059] Device 1 is provided with a deployment mechanism 40 having a manually operable handle 41. The handle 41 has an annular wall 43 defining a ring-shaped opening 42. The handle 41 is slidably mounted within a central space 30 between the elongated wall members 12, 14. The elongated wall members 12, 14 each include linear tracks 26, 28 for guiding a linear reciprocating movement of the handle 41 between the proximal end and the distal end 16, 18 of the housing 10. The edge of the handle 41 engages the linear tracks 26, 28 of the wall members 12, 14.

[0060] The handle 41 is configured to receive one or more fingers of a user within the ring-shaped opening 42. Thereby, the user can slide the handle 41 within the central space 30 between the proximal end 16 and the distal end 18 by a pulling / pushing action. The handle 41 is configured to remain in a fixed position at the proximal end 16 by means such as a detent action until the handle 41 is slid to the distal end 18 by the force manually applied by the user.

[0061] Device 1 is provided with a sample collection member 60 for collecting a nasal secretion sample. The sample collection member 60 includes a body 61 extending longitudinally between a proximal end 62 and a distal end 64. The sample collection member 60 is configured to absorb a predetermined amount of nasal secretion sample. Preferably, the sample collection member 60 absorbs a sample in an amount within 10 - 200 μl or a predetermined amount suitable for subsequent analysis accuracy. Preferably, the material of the sample collection member 60 is absorbent and paper-based. In another embodiment, the material of the sample collection member 60 is nylon-based, cotton-based, polyurethane-based, porous polymer-based, foam-based, cellulose-based, hydrophilic or hydrophobic porous material-based, open cell or closed cell material-based, flexible polymer material-based, or made of another material suitable for volume control. Further, preferably, the sample collection member 60 includes a plurality of strip regions of the same or different volumes separated by snap points. In another embodiment, the sample collection member 60 includes a non-absorbent mesh strip having a void volume.

[0062] Accordingly, the housing 10 houses a deployment mechanism 40 that is operable to move the sample collection member 60 between a storage and a deployed position. In the storage position, the housing 10 encloses the sample collection member 60, and in the deployed position, the sample collection member 60 projects from the housing 10 and is inserted into the nasal cavity to collect a nasal secretion sample.

[0063] The proximal end 62 of the sample collection member 60 is connected to the handle 41. In the embodiments of FIGS. 1-3, the handle 41 has a support member 50 for connecting the sample collection member 60 to the handle 41. The support member 50 is fixed to an annular wall 43 around the ring-shaped opening 42. The support member 50 includes a longitudinal recess 52 for receiving and securely holding the proximal end 62 of the sample collection member 60 therein. The support member 50 is preferably formed integrally with the annular wall 43 of the handle 41. The support member 50 is sized to be receivable within an opening 22 in the end wall 20 of the housing 10 during use.

[0064] As shown in FIGS. 1 and 2, the sample collection member 60 is entirely disposed within the central space 30 of the housing 10, which is referred to herein as the "storage position". In the storage position, the handle 41 is at the proximal end 16 of the housing 10. During use, the handle 41 moves from the proximal end 16 to the distal end 18 of the housing 10. When the handle 41 moves to the distal end 18 of the housing 10, the sample collection member 60 moves out of the central space 30 through the opening 22 in the end wall 20 and substantially outside the housing 10. As shown in FIGS. 3 and 4, when the handle 41 reaches the distal end 18 and can no longer move further, the sample collection member 60 is located outside the end wall 20 of the housing, which is referred to herein as the "deployed position". When the sample collection member 60 is in the deployed position, the support member 50 is located within the opening 22 in the end wall 20 of the housing 10. In an embodiment, the device 1 may have a mechanism for releasably holding the handle 41 and the sample collection member 60 in the deployed position.

[0065] In the deployed position, the sample collection member 60 is configured to collect a respiratory secretion sample. Preferably, the sample collection member 60 is deployed directly into the patient's nasal cavity so as to minimize sample contamination. Preferably, the sample collection member 60 is sized to comfortably fit into small nostrils and enable sampling for various age groups. The user can control the speed at which the handle 41 is moved to deploy the sample collection member 60, reducing the discomfort to the patient that may be caused by a sudden insertion of the sample collection member 60, especially when the patient has a septal deviation or polyps.

[0066] The sample collection member 60 preferably includes visual volume indicator means such as a dye indicator. The visual volume indicator provides a visual indication during or after sample collection depending on when a predetermined amount of nasal secretion has been collected by the sample collection member 60. The visual volume indicator is selected from the group including polymer beads, peroxide or oxidation reactions, leuco dyes, food dyes, and changes in the refractive index of the material.

[0067] After the sample has been collected by the sample collection member 60, the user can manually slide the handle 41 from the distal end 18 to the proximal end 16 of the housing 10. At this time, the sample collection member 60 is retracted through the opening 22 of the end wall 20 of the housing 10 until the sample collection member 60 is completely disposed within the central space 30 of the housing 10. This is referred to herein as the "stored position".

[0068] The opening 22 is surrounded by the end wall 20 and has a cross-section corresponding to the cross-section of the sample collection member 60 when the sample collection member 60 contains a sample of a predetermined amount or less. Since the sample collection member 60 can expand when absorbing the sample, the cross-sectional dimension of the opening 22 may be slightly larger than the cross-sectional dimension of the unused sample collection member 60. However, a relatively strict tolerance is provided between the cross-sectional dimension of the sample collection member 60 and the cross-sectional dimension of the opening 22. The end wall 20 around the opening 22 is operable to wipe off excess sample from the outer surface of the sample collection member 60 when the sample collection member 60 is drawn through the opening 22. Removing excess nasal secretion sample from the sample collection member 60 is advantageous with respect to maintaining volume control and, as a result, analysis accuracy.

[0069] To suppress the instability and deterioration of the collected sample, especially when stored at room temperature, the housing 10 of the apparatus 1 preferably includes drying means for drying the sample and maintaining a low relative humidity. Alternatively, the housing 10 is configured to be disposed within a container that houses drying means for drying the sample and maintaining a low relative humidity. The drying means is preferably silica gel, calcium oxide, calcium sulfate, montmorillonite, or other suitable means. Alternatively, the collected sample is stored in a buffer solution, refrigerated if used on the same day, or lyophilized or frozen if used long-term.

[0070] The foregoing further embodiments of the present invention include features that are the same as or equivalent to those described in the embodiments of FIGS. 1 to 6 above. Similar features are described in similar terms. For the sake of brevity, only the features of the foregoing further embodiments of the present invention that are substantially different in form and / or function from the embodiments of FIGS. 1 to 6 will be described in detail below.

[0071] In FIGS. 7 and 8, the device 101 includes a housing 110 having a proximal end 116 and a distal end 118, and wall members 112, 114 that are parallel and spaced apart to define a central space 130. In this embodiment, the wall members 112, 114 include a set of protrusions 121, 124 that extend outwardly and are disposed toward the distal end 118. The distal end 118 of the housing 110 includes an elongated tip portion 180 having an additional set of small protrusions 126, 128. At least a portion of the tip portion 180 can be inserted into a patient's nose or throat.

[0072] The central space 130 houses a deployment mechanism 140 that includes a handle 141, a support member 150, and a sample collection member 160. An end wall 120 having an opening 122 for wiping excess sample from the sample collection member 160 is located at the distal end of the elongated tip portion 180. As shown in FIG. 7, the sample collection member 160 is in a retracted position where the sample collection member 160 fits completely within the central space 130 of the housing 110. In use, the handle 141 is moved toward the distal end 118 of the housing 110 such that the sample collection member 160 is deployed from the elongated tip 180 through the opening 122 to an extended position. When a nasal secretion sample is collected, the sample collection member 160 is retracted back through the opening 122, thereby wiping excess nasal secretion from the sample collection member 160 by the end wall 120 around the opening 122.

[0073] The embodiments shown in FIGS. 9 and 10, and FIGS. 11 and 12 have different configurations of the deployment mechanism. Referring to the embodiment of the apparatus 201 shown in FIGS. 9 and 10, the deployment mechanism 240 includes a scroll wheel 248. The wall members 212, 214 of the housing 210 are configured to be joined to completely surround the central space 230. FIG. 10 shows the apparatus 201 in which the internal space 230 and the support handle 250 are revealed by removing one of the wall members 214. In use, the sample collection member 260 is deployed by manually rotating the scroll wheel 248. The support member 250 handle has a set of linear teeth 251 that are engaged by a set of teeth 249 provided around the scroll wheel 248. When the scroll wheel 248 rotates in the opposite direction, the sample collection member 260 retracts into the housing 210, whereby excess nasal secretions are wiped from the sample collection member 260 by the end wall 220 surrounding the opening 222.

[0074] Referring to the embodiment of the apparatus 301 shown in FIGS. 11 and 12, the handle 341 of the deployment mechanism 340 has a pair of opposing solid gripping surfaces 342a, 342b configured to be gripped between the user's thumb and index finger. The wall members 312, 314 of the housing 310 are joined and configured to substantially completely surround the central space 330. The user grips the gripping surfaces 342a, 342b and slides the handle 341 along the elongated linear openings 326, 328 through the wall members 312, 314. The gripping surfaces 342a, 342b of the handle 341 are coupled to a support member 350 located within the space 330 through the linear openings 326, 328. The support member 350 is coupled to the sample collection member 360 in the manner described above. When the user grips the gripping surfaces 342a, 342b and slides the handle 341 to the distal end 318 of the housing 310, the sample collection member 360 is deployed. When the handle 341 slides from the distal end 318 to the proximal end 316 of the housing 310, the sample collection member 360 retracts. When the retracting sample collection member 360 is pulled back through the opening 322, excess nasal secretions are wiped from the sample collection member 360 by the end wall 320 surrounding the opening 322.

[0075] FIG. 13 shows an embodiment of an apparatus 401 comprising a sample collection member 460, a handle 441, and an elongate support member 450 extending between the handle 441 and the sample collection member 460. The elongate support member has an opening (430) at its distal end 418 for receiving the sample collection member therein, with at least one side of the sample collection member being exposed so as to contact nasal tissue.

[0076] The elongate support member 450 extends between the handles 441 at its proximal end 416 and extends to a distal end 418 including a distal tapered portion 413 so as to be inserted into the nasal cavity. The elongate member 450 further has a proximal tapered portion 415 directly adjacent to the handle 441 to limit the extent to which the apparatus 401 can be inserted into the nasal cavity.

[0077] In use, the user holds the handle 441 and inserts the distal end 418 into the nasal cavity. Thereby, the sample collection member 460 contacts the tissue at the target location within the nasal cavity, and the sample collection member 460 collects a predetermined amount of nasal secretion sample at the target location.

[0078] FIG. 14 shows an embodiment of an apparatus 501 comprising a sample collection member 560, wherein the elongate support member 550 comprises a pair of arms 552, 554 supporting respective sample collection members 560 at their distal ends. The handle 541 has a pair of gripping members 542, 544 at the proximal ends of the arms 552, 554 and a pair of frame members 555, 556 for supporting the sample collection members 560 at the distal ends of the arms 552, 554. The apparatus 501 is operable such that when the gripping members 542, 544 are manually closed together, the sample collection members 560 are closed together for insertion into the nasal cavity. When the gripping members 542, 544 are released with the sample collection members disposed within the nasal cavity, the sample collection members 560 are biased apart to contact the nasal tissue.

[0079] The frame members 555, 556 at the distal ends of the arms 552, 554 include distal tapered ends 513, 514 for insertion into the nasal cavity. To limit the extent to which the apparatus 501 can be inserted into the nasal cavity, the elongate member 550 further includes a proximal tapered portion 515 directly adjacent to the handle 541.

[0080] When in use, the user holds the gripping members 542, 544 of the handle 541 and inserts both arms 552, 554 into either one or both nostrils simultaneously, thereby inserting the distal end 518 into the nasal cavity. As a result, the sample collection member 560 contacts the tissue at the target position within the nasal cavity, and the sample collection member 560 collects a predetermined amount of nasal secretion sample at the target position.

[0081] Figures 15 - 16 show an embodiment of an apparatus 601 comprising a sample collection member 660, a handle 641, and an elongate support member 650 extending between the handle 641 and the sample collection member 660. A pair of pivot frame members 655, 656 are disposed towards the distal end 618 of the elongate support member 650. Each pivot frame member 655, 656 supports at least one or a plurality of parts of the sample collection member 660.

[0082] In the embodiment shown in Figures 15 and 16, the elongate sample collection member 660 passes through the opening 612 at the distal end 618 of the elongate support member 650. Parts of the sample collection member 660 are supported by a pair of pivot frame members 655, 656. The end of the sample collection member 660 is fixed to the elongate support member 650 adjacent to the pivot frame members 655, 656, or is fixed to the pivot frame members 655, 656 themselves by means such as adhesive or mechanical attachment.

[0083] The pivot frame members 655, 656 are arc-shaped and are connected to the elongate support member 650 by pivot connections 657. Thus, the pivot frame members 655, 656 are movable relative to each other between an open position and a closed position. In the illustrated embodiment, the pivot movement of the frame members 655, 656 is realized by the material forming the frame members 655, 656 being elastic and flexible. However, in another embodiment, the pivot movement is realized by a hinge mechanism and biasing means.

[0084] The frame members 655, 656 are biased towards the open position and, when inserted into the nasal cavity, the frame members 655, 656 and one or more sample collection members 660 supported thereon contact the nasal tissue, thereby being biased towards the closed position.

[0085] Figures 17-20 illustrate embodiments of an apparatus 701 comprising a sample collection member 760, a handle 741, and an elongate support member 750 extending between the handle 741 and the sample collection member 760. One or more deployment frame members 755, 756 are disposed towards the distal end of the elongate support member 750. Each deployment frame member 755, 756 supports one or more at least portions of the sample collection member 760.

[0086] The frame members 755, 756 are disposed within one or more grooves or recesses 762 within the elongate support member 750 towards the distal end 718 of the elongate support member 750. The frame members 755, 756 are disposed within grooves or recesses 762, 764 on both sides of the elongate support member 750, facing away from each other towards the distal end 718.

[0087] In the embodiments of Figures 17-20, the elongate sample collection member 760 passes through the opening 712 at the distal end 718 of the elongate support member 750. Components of the sample collection member 760 are supported by a pair of frame members 755, 756. The ends of the sample collection member 760 are fixed to the elongate support member 750 adjacent the proximal ends of the frame members 755, 756 or are fixed to the frame members 755, 756 themselves, such as by an adhesive or mechanical attachment.

[0088] In the embodiments, the deployment frame members 755, 756 have a non-operating state in which the frame members 755, 756 are closed to each other, as shown in Figures 17 and 19, and a deployed state in which the frame members 755, 756 are open and separated from each other, as shown in Figures 18 and 20. Thus, in the non-operating state shown in Figures 17 and 19, the frame members 755, 756 are flat. In the deployed state shown in Figures 18 and 20, the frame members 755, 756 are arcuate.

[0089] The device 701 includes a mechanism for selectively deploying or closing the frame members 755, 756. The mechanism includes a pair of manually operable handle members 741, 742 at the proximal end of the elongated support member 750. The handle members 741, 742 are configured to open the frame members 755, 756 by being manually closed towards each other as shown in FIGS. 18 and 20, and to close the frame members 755, 756 together by being manually opened so as to be spaced apart from each other as shown in FIGS. 17 and 19.

[0090] As shown in FIGS. 19 and 20, the elongated support member 750 includes an outer tube member 751 and an inner tube member 752. The outer tube member 751 is connected to the distal side of the handle member 741 at the proximal end 716, and the inner tube member 752 is connected to the proximal side of the handle member 742 at the proximal end 719. The inner tube member 752 is slidable within the outer tube member 751. Thus, when the handle members 741, 742 move axially relative to each other, the inner tube member 752 slides axially relative to the outer tube member 751.

[0091] The frame members 755, 756 include, are integrally formed with, or are connected to the distal end 753 of the inner tube member 752. The frame members 755, 756 are preferably composed of a flexible material having elasticity and are disposed between the distal end 753 of the inner tube member 752 and the distal end 754 of the outer tube member 751 at the distal end 718 of the elongated support member 750.

[0092] In use, when the handle members 741, 742 are manually closed towards each other, the inner tube member 752 slides within the outer tube member 751, thereby compressing the frame members 755, 756 between the end of the inner tube member 752 and the distal end of the elongated support member 750. Thus, the frame members 755, 756 are forced into a deployed state. Therefore, the frame members 755, 756 open while being spaced apart from each other as shown in FIGS. 18 and 20.

[0093] On the other hand, when the handle members 741 and 742 move apart from each other, the inner tube member 752 slides in the opposite direction inside the outer tube member 751, thereby removing all compressive forces from the frame members 755 and 756. Due to either or both of the elasticity of the frame members 755 and 756 or the force applied through the inner tube member 751, the frame members 755 and 756 are closed together as shown in FIGS. 17 and 19.

[0094] In another embodiment, the deployed frame members 755 and 756 have a non-operating state in which the frame members 755 and 756 are in a deployed state, as shown in FIGS. 18 and 20. Thus, due to either the force applied by the inner tube member 751 or an external force directly applied to the frame members 755 and 756, such as during insertion into the nasal cavity, the frame members 755 and 756 are closed together as shown in FIGS. 17 and 19.

[0095] When the handle members 741 and 742 move apart from each other, the inner tube member 752 slides inside the outer tube member 751, and a tensile force is applied to bias the frame members 755 and 756 to the closed position as shown in FIGS. 17 and 19. When the handle members 741 and 742 are released, the deployed frame members 755 and 756 are in a deployed state as shown in FIGS. 18 and 20. In another embodiment, as shown in FIGS. 17 and 19, the device 701 is configured such that the movement of the handle members 741 and 742 forces the frame members 755 and 756 to move to the closed position.

[0096] As shown in the embodiment of FIG. 21, the sheath 800 is configured to be used with the device 701 of FIGS. 17-20. Specifically, the sheath 800 includes a cylindrical tube member 805 with a distal end 806 closed and a proximal end 804 open. The tube member 805 is configured to receive the elongated support member 750 of the device 701 through the opening at the proximal end 804. The tube member 805 includes a cylindrical wall 802 that includes a plurality of openings 807 that allow air to flow through the wall 802. The air flow through the wall 802 of the tube member 805 enables the air drying of the sample contained within the collection member 760 while protecting the sample.

[0097] The embodiment of the sheath 800 of FIG. 21 can also be configured to be used with the devices 401, 601, 701 of FIGS. 13 and 15-20.

[0098] In use, the embodiments of the devices 1, 101, 201, 301, 401, 501 and 701 can be used to collect a predetermined amount of a nasal secretion sample collected from a patient into a container or another suitable container. The user can deploy the sample collection members 60, 160, 260, 360 into the nasal secretion stored in a container or tube, or absorbed by an absorbent material or a cotton swab. Thus, the devices 1, 101, 201, 301 are used to collect an accurate amount of sample from a certain amount of sample collected from a patient into a container, or some other absorbent material or cotton swab, and the analysis accuracy can be ensured.

[0099] Although the present invention has been described with reference to specific examples, it will be understood by those skilled in the art that the present invention can be embodied in many other forms in accordance with the broad principles and spirit of the invention disclosed herein.

Claims

1. An apparatus for collecting a nasal secretion sample, comprising: a sample collection member having a material for collecting a predetermined amount of nasal secretion sample; a handle; an elongated support member extending between the handle and the sample collection member and supporting the sample collection member; and the apparatus is configured such that a user holding the handle contacts the sample collection member with tissue at a target position within the nasal cavity, and the sample collection member collects a predetermined amount of nasal secretion sample at the target position. Apparatus.

2. The apparatus according to claim 1, wherein the sample collection member comprises an absorbent material configured to absorb the nasal secretion sample.

3. The apparatus according to claim 1, wherein the sample collection member is an absorbent material of a certain length, and the absorbent material has one or more points for removing a part of the absorbent material in order to adjust the predetermined absorption capacity of the sample collection member.

4. The apparatus according to claim 1, wherein the sample collection member includes a non-absorbent mesh strip having a void volume for holding the nasal secretion sample.

5. The apparatus according to claim 1, wherein the sample collection member is configured to collect a nasal secretion sample within a range of minimum and maximum volumes.

6. The apparatus according to claim 1, wherein the sample collection member has a visual indicator that responds to the collection of a predetermined amount of the nasal secretion by the sample collection member in order to provide a visual indication.

7. The apparatus according to claim 6, wherein the visual volume indicator includes a dye indicator.

8. The apparatus according to claim 1, further comprising a deployment mechanism operable to move the sample collection member between a storage position and a deployment position, wherein in the storage position, the sample collection member is enclosed within a housing, and in the deployment position, the sample collection member protrudes from the housing for insertion into the nasal cavity to collect a nasal secretion sample.

9. The apparatus according to claim 8, wherein the deployment mechanism comprises a manually operable base member connected to the sample collection member via the support member, and the base member is movable relative to the housing to move the sample collection member between the storage and deployment positions.

10. The apparatus according to claim 1, wherein the housing comprises an excess sample removal device for removing excess sample on the surface of the sample collection member.

11. The surplus sample removing device according to claim 10, further comprising a wiper that contacts the surface of the sample collection member when the sample collection member moves from the deployment position to the storage position to wipe off surplus nasal secretion samples from the surface.

12. The wiper includes a wall surrounding an opening having a cross-section dimensioned to be equal to the cross-section of the sample collection member that accommodates a sample of the predetermined amount or less. Thereby, when the sample collection member is drawn out through the opening, surplus samples are wiped off from the surface of the sample collection member. The device according to claim 11.

13. The device according to claim 1, wherein at the deployment position, the sample collection member protrudes from the housing so as to contact a nasal secretion sample collected in a container or an absorbent sample collection material.

14. The device according to claim 1, wherein the housing is configured to be inserted into a container containing a desiccant for drying the sample and maintaining a low relative humidity.

15. The device according to claim 1, wherein the housing is configured to be inserted into a container containing a preservative such as a buffer solution.

16. The device according to claim 1, wherein the elongated support member has an opening at its distal end for accommodating the sample collection member therein, and at least one side surface of the sample collection member is exposed so as to contact nasal tissue.

17. The device according to claim 1, wherein at the distal end of the elongated support member, there are a pair of arms each supporting a respective sample collection member, and the handle has a pair of gripping members at the proximal ends of the arms. When the gripping members are manually closed together, the sample collection members close together so as to be inserted into one nostril or both nostrils simultaneously.

18. The device according to claim 17, wherein the sample collection members are biased away from each other so as to contact nasal tissue when the gripping members are released while the sample collection members are disposed within the nasal cavity.

19. The device according to claim 1, further comprising one or more pivotable frame members disposed toward the distal end of the elongated support member, each of the pivotable frame members supporting at least a part of one or more of the sample collection members.

20. The device according to claim 19, wherein the pivotable frame members are arcuate and are pivotally connected to the elongated support member so as to be movable relative to each other between an open position and a closed position.

21. The pivotal frame member is biased toward the open position, and when the frame member and the one or more sample collection members supported thereby are inserted into the nasal cavity, they contact the nasal tissue, whereby they are biased toward the closed position. The apparatus according to claim 20.

22. Comprising one or more deployment frame members disposed toward the distal end of the elongated support member, each of the deployment frame members supporting at least a part of one or more of the sample collection members. The apparatus according to claim 1.

23. The deployment frame member has a non-operating state in which the frame members are closed to each other and a deployed state in which the frame members are separated and opened from each other. The apparatus according to claim 22.

24. The frame member is flat in the non-operating state, and the frame member is arcuate in the deployed state, or vice versa. The apparatus according to claim 23.

25. Comprising a mechanism for selectively deploying or closing the frame member, the mechanism comprising a pair of manually operable handle members at the proximal end of the elongated support member, and when the handle members are manually closed to each other, the frame member opens, and when the handle members are manually opened, the frame member closes, or vice versa. The apparatus according to claim 23.

26. The frame member is biased toward the non-operating state, and when inserted into the nasal cavity, the frame member is movable to the deployed state, and the frame member and the one or more sample collection members supported thereon contact the nasal tissue. The apparatus according to claim 23.

27. A method for collecting a nasal secretion sample, comprising: deploying a sample collection member from a sample collection device into a patient's nasal cavity; collecting a predetermined amount of nasal secretion sample on the sample collection member; storing the sample collection member containing the predetermined amount of nasal secretion sample in the sample collection device. The method.

28. Wiping off excess nasal secretion sample from the sample collection member when storing the sample collection member. The method according to claim 27.

29. Contacting the deployed sample collection member with a nasal secretion sample collected in a container or an absorbent sample collection material. The apparatus according to claim 27.

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