Device and method for collecting paranasal sinus secretions

Abstract

The invention provides a device for collecting a nasal secretion sample. The device comprises a sample collection member comprising a material for collecting a predetermined volume of a nasal secretion sample. The device also includes a handle and an elongate support member extending between the handle and the sample collection member for supporting the sample collection member. The device is adapted for a user to hold the handle to position the sample collection member in contact with the tissue at a target location within the nasal cavity at which the sample collection member collects a predetermined volume of a nasal secretion sample.

Description

Technical Field

[0001] The present invention relates to a device and method for collecting sinus secretion samples for subsequent analysis. In particular, the present invention relates to a device and method for accurate volumetric sampling of nasal secretions. The present invention is particularly applicable to nasal secretion samples, however, it should be recognized that the present invention can be more broadly applied to other samples, such as sputum. Background Art

[0002] Inflammatory sinus disease is characterized by inflammation of the mucous membrane lining 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 responses such as hay fever. In some rare cases, especially in people with a weakened immune system, fungal infections may be the cause. Rhinitis can be divided into allergic rhinitis and non-allergic rhinitis. Allergic rhinitis is caused by allergens such as dust, pollen and mold, while non-allergic rhinitis may be caused by hormonal imbalances, environmental triggers such as perfumes and smoke, or taking medications including beta blockers and ACE inhibitors.

[0004] Inflammation of the mucous membranes prevents mucus from draining, which can lead to mucus congestion. Symptoms associated with sinus inflammation include swelling, pressure, and pain in the sinuses. Other symptoms commonly associated with sinusitis and rhinosinusitis include sneezing, fever, headache, loss of smell, sore throat, mucus secretion, and coughing.

[0005] These sinus inflammations are common conditions in humans, however, accurately diagnosing the causes of these conditions remains a challenge. When a patient presents with symptoms associated with these conditions, a general practitioner (GP) will typically perform a physical examination by examining the face, ears, nose, throat, and neck to check for signs of swelling or congestion. If symptoms are severe or persistent, the GP will refer the patient to an ear, nose, and throat (ENT) specialist. ENT specialists typically use specialized tools such as endoscopes, scopes, and CT scanners to examine the sinus cavities. Once sinus inflammation is confirmed by a physical examination, testing will be performed to determine the cause of the condition.

[0006] If an allergen is suspected to be the cause, your healthcare provider will perform allergy testing. If a virus or bacteria is suspected to be the cause, a sampling technique may be used to collect a sample from the sinus cavity for subsequent testing. There are two main types of sinus sampling techniques: bulk surface fluid collection and local surface fluid collection.

[0007] Bulk surface fluid collection includes forced exhalation of nasal secretions, nasal suctioning using a suction device, or nasal lavage, in which a saline solution is sprayed into the nasal cavity to collect a sample of fluid.

[0008] Local surface fluid collection involves the use of absorbent materials, such as cotton wool, and wiping techniques to recover a sample of sinus secretions. The most common methods of obtaining sinus secretion samples include oropharyngeal and / or nasopharyngeal swabs. The swab is inserted into the patient's nose and parallel to the nasal cavity and the floor of the septum. As long as there are no obstructions in the nasal cavity, the swab will continue to move in this direction until it reaches the nasopharynx. When the swab reaches the nasopharynx, the swab is either rotated to "scrape" the mucosa or the side of the nose is pinched to press the mucosa against the swab, allowing the sinus secretions to be absorbed. After the swab is removed from the patient's nasal cavity, it is stored in culture medium or buffered solution and shipped through the cold chain for subsequent testing.

[0009] Nasopharyngeal swabs are an invasive and uncomfortable method for patients and usually require highly trained medical personnel to perform the swab collection. These abrasive sampling techniques may further introduce contaminants such as blood into the sample. Alternatively, samples are collected directly from the sinus cavities during a nasal endoscopy. Endoscopic examination of pus confirms the diagnosis of sinusitis and allows the specialist to place a small swab directly into the abnormal mucus. Endoscopy is also very invasive and uncomfortable and may require the patient to be sedated.

[0010] Testing of collected sinus samples is typically performed in a laboratory, and it can take several days for healthcare professionals and patients to receive results. Laboratory testing requires small sample volumes (typically less than or equal to 50 μl). Processing typically involves diluting the sample with reagents and requires a specific final analyte concentration to ensure accuracy. Any deviation in the final analyte concentration can amplify the margin of error, leading to inaccurate results and, therefore, an inadequate diagnosis. As previously mentioned, sampling devices are typically made of absorbent materials to absorb sinus secretions, but existing sampling devices are unable to collect standardized sample volumes consistent with the amount required for accurate testing.

[0011] Additionally, existing sampling devices often require abrasive sampling techniques that may introduce contaminants such as blood into the sample, and the size and insertion depth of the sampler may be incompatible with the patient, causing discomfort.

[0012] Therefore, there is a need for a method of collecting sinus secretion samples with volume control. There is also a need for a method of collecting sinus secretion samples within a minimum and maximum sample volume to ensure assay accuracy. In addition, there is a need for a non-abrasive method to collect sinus biospecimens for determining the cause of an identified inflammatory condition.

[0013] Any discussion of the background art throughout the specification should not be taken as an admission that any document or other material referred to is published, known or forms part of the common general knowledge.

[0014] Throughout the description and claims of this specification, the word "comprise" and variations thereof, such as "comprises" and "comprising" are not intended to exclude other additives, steps or integers. Summary of the invention

[0015] Thus, in one aspect, the present invention relates to a device for collecting a nasal secretion sample. The device comprises a sample collection member comprising a material for collecting a predetermined volume of a nasal secretion sample, a handle, and an elongated support member extending between the handle and the sample collection member and for supporting the sample collection member. The device is adapted for a user to hold the handle to position the sample collection member at a target location in the nasal cavity in contact with tissue, where the sample collection member collects a predetermined volume of a nasal secretion sample.

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

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

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

[0019] Preferably, the sample collection member comprises an absorbent material adapted to absorb the nasal secretion sample. Preferably, the sample collection member comprises a section of absorbent material having one or more points for separating a portion of the absorbent material for adjusting the predetermined absorption volume of the sample collection member. In an embodiment, the sample collection member comprises a non-absorbent mesh strip comprising a void volume for retaining the nasal secretion sample.

[0020] Preferably, the sample collection member is configured to collect nasal secretion samples within a minimum volume range and a maximum volume range. In an embodiment, the sample collection member includes a visual indicator that provides a visual indication in response to a predetermined volume of nasal secretion being collected by the sample collection member. In an embodiment, the visual volume indicator includes a dye indicator.

[0021] Preferably, the deployment mechanism comprises a manually operable handle connected to the sample collecting member, wherein the handle is movable relative to the housing to move the sample collecting member between the retracted position and the deployed position.

[0022] Preferably, the housing comprises an excess sample removal device for removing excess sample from the surface of the sample collection member. In an embodiment, the excess sample removal device comprises a wiper for contacting the surface of the sample collection member when the sample collection member moves from the deployed position to the retracted position to wipe excess nasal secretion sample from the surface. Preferably, the wiper comprises a wall surrounding a hole, the cross-section of the hole having a size equivalent to the cross-section of the sample collection member, the sample collection member containing no more than a predetermined volume of sample, so that when the sample collection member is pulled out through the hole, the excess sample is wiped off the surface of the sample collection member.

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

[0024] In an embodiment, the housing is configured to be inserted into a container containing a desiccant to dry the sample and maintain 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 comprises a hole at a distal end thereof for receiving a sample collecting member therein, wherein at least one side of the sample collecting member is exposed to contact nasal tissue.

[0026] Preferably, the elongated support member comprises a pair of arms, each arm supporting a respective sample collection member at its distal end, wherein the handle comprises a pair of gripping members at the proximal ends of the arms, wherein manually closing the gripping members together causes the sample collection members to close together for insertion into one nostril or into both nostrils simultaneously.

[0027] Preferably, when the sample collection member is located in the nasal cavity, upon release of the gripping member, the sample collection member is biased apart to contact nasal tissue.

[0028] In embodiments, the device further comprises one or more pivoting frame members positioned toward the distal end of the elongated support member, wherein each pivoting frame member supports at least a portion of the one or more sample collecting members.

[0029] Preferably, the pivoting frame member has an arcuate shape and is pivotally connected to the elongated support member to be movable relative to each other between an open position and a closed position.

[0030] Preferably, the pivoting frame member is biased toward an open position, and wherein upon insertion into the nasal cavity, the frame member and one or more sample collection members supported thereon come into contact with nasal tissue and are thereby urged toward the closed position.

[0031] In embodiments, the device comprises one or more expandable frame members positioned toward a distal end of the elongated support member, wherein each expandable frame member supports at least a portion of one or more sample collecting members.

[0032] Preferably, the expandable frame members have a rest state in which the frame members are closed together and an expanded state in which the frame members are opened apart from each other.

[0033] Preferably, in the rest state, the frame members are flat, and in the deployed state, the frame members are curved, or vice versa.

[0034] In an embodiment, the device includes a mechanism for selectively expanding or closing the frame members, the mechanism comprising a pair of manually operable handle members located at the proximal end of the slender support member, wherein manually closing the handle members together opens the frame members, and manually opening the handle members closes the frame members, and vice versa.

[0035] Preferably, the frame member is biased toward a resting state, and wherein when inserted into a nasal cavity, the frame member is movable to a deployed state wherein the frame member and one or more sample collection members supported thereon contact nasal tissue.

[0036] Embodiments of the device may be used to collect a precise volume of a nasal secretion sample previously collected from a patient in a container or another suitable vessel to ensure assay accuracy.

[0037] In another aspect, the present invention relates to 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 volume of the nasal secretion sample in the sample collection member; and retracting the nasal secretion sample containing the predetermined volume into the sample collection device.

[0038] Preferably, the method includes wiping excess nasal secretion sample from the sample collecting member during retraction of the sample collecting member.

[0039] Optionally, the method includes contacting the expanded sample collection member with a nasal secretion sample collected in a container or absorbent sample collection material. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] The present invention will now be described in more detail with reference to preferred embodiments shown in the accompanying drawings, in which:

[0041] Figure 1 A perspective view of a sample collection device according to an embodiment of the present invention is shown, including a housing, a deployment mechanism, a sample collection member, and a wiping mechanism.

[0042] Figure 2Shows Figure 1 Front view of the sample collection device.

[0043] Figure 3 and Figure 4 Shows Figure 1 Perspective view and front view of a sample collection device with the sample collection component unfolded.

[0044] Figure 5 and Figure 6 Shows Figure 1 Perspective and front views of a sample collection device showing the sample collection member in its retracted state.

[0045] Figure 7 A perspective view of a sample collection device according to another embodiment of the present invention is shown, wherein the sample collection member is retracted.

[0046] Figure 8 Shows Figure 7 A perspective view of a sample collection device with the sample collection member unfolded.

[0047] Fig. 9 A perspective view of a sample collection device according to another embodiment of the present invention is shown, wherein the deployment mechanism is a roller.

[0048] Fig.10 Shows Fig. 9 A partially exploded perspective view of a sample collection device with the elongated member unfolded.

[0049] Fig.11 A perspective view of a sample collection device according to yet another embodiment of the present invention is shown, wherein the deployment mechanism includes a slider.

[0050] Fig.12 Shows Fig.11 A perspective view of a sample collection device with the sample collection member unfolded.

[0051] Fig.13 A perspective view of a sample collection device according to yet another embodiment of the present invention is shown, comprising an elongated support member including a hole at a distal end thereof for receiving a sample collection member.

[0052] Fig.14 A perspective view of a sample collection device according to yet another embodiment of the present invention is shown, wherein an elongated support member includes a pair of arms, each arm supporting a respective sample collection member at a distal end thereof.

[0053] Fig.15 and Fig.16A perspective view of a sample collection device according to yet another embodiment of the present invention is shown, the device comprising a pair of pivoting frame members positioned toward the distal end of an elongated support member, wherein each pivoting frame member supports at least a portion of a sample collection member.

[0054] Fig.17 and Fig.18 A perspective view of a sample collection device according to yet another embodiment of the present invention is shown, wherein portions of a sample collection member are supported by a pair of expandable frame members positioned toward the distal end of an elongated support member, wherein each expandable frame member supports at least a portion of the sample collection member, wherein Fig.17 The expanded frame member is shown in a static state. Fig.18 The expanded frame member is shown in an expanded state.

[0055] Fig.19 and Fig. 20 Shows Fig.17 and Fig.18 A cross-sectional view of a device, wherein Fig.19 The expanded frame member is shown in a static state. Fig. 20 The expanded frame member is shown in an expanded state.

[0056] Fig.21 Shown with Figures 17 to 20 A perspective view of a sheath for use with the device. DETAILED DESCRIPTION

[0057] The present invention relates to a device and method for collecting nasal secretion samples. Several embodiments are described herein, but the sample collection device broadly includes a device for collecting nasal secretion samples, the device including a sample collection member, the sample collection member including a material for collecting a predetermined volume of nasal secretion sample, a handle, and an elongated support member extending between the handle and the sample collection member and for supporting the sample collection member, wherein the device is suitable for a user to hold the handle to position the sample collection member at a target location in the nasal cavity to contact tissue, and the sample collection member collects a predetermined volume of nasal secretion sample at the target location.

[0058] Figure 1-Figure 6A schematic diagram of a device 1 for collecting a sample of nasal secretions according to one embodiment of the present invention is shown. The device 1 includes a housing 10 having elongated wall members 12, 14 extending between a proximal end 16 and a distal end 18. The wall members 12, 14 are arranged in parallel and spaced apart and define a central cavity 30. The central cavity 30 is elongated and extends from the proximal end 16 of the housing 10 to the distal end 18. The housing 10 is rectangular in shape and the wall members 12, 14 are generally linear, extending from the curved or arcuate proximal end 18 and leading to tapered ends 13, 15. The ends 13, 15 taper toward an end wall 20 at the distal end 18. The end wall 20 of the housing 10 includes an aperture 22.

[0059] The device 1 includes a deployment mechanism 40 including a manually operable handle 41. The handle 41 includes an annular wall 43 defining an annular opening 42. The handle 41 is slidably mounted within the central cavity 30 between the elongated wall members 12, 14. The elongated wall members 12, 14 include respective linear tracks 26, 28 for guiding the handle 41 to move back and forth in a linear direction between the proximal and distal ends 16, 18 of the housing 10. The edge of the handle 41 engages with 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 annular opening 42, thereby allowing the user to slide the handle 41 within the central cavity 30 between the proximal end 16 and the distal end 18 through a pull / push action. The handle 41 is configured to remain in a fixed position at the proximal end 16, such as by operation of a brake, until the user manually applies a force to slide the handle 41 to the distal end 18.

[0061] The device 1 includes a sample collection member 60 for collecting nasal secretion samples. 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 volume of nasal secretion samples. Preferably, the sample collection member 60 absorbs a sample volume within 10-200 μl or a predetermined volume suitable for subsequent measurement accuracy. Preferably, the material of the sample collection member 60 is absorbent and paper-based. In other embodiments, the material of the sample collection member 60 is based on nylon, cotton, polyurethane, porous polymer, foam, cellulose, hydrophilic or hydrophobic porous material, open-cell or closed-cell material, flexible polymer material, or another material suitable for volume control. In addition, the sample collection member 60 preferably includes a plurality of strip regions having the same or different volume capacities, which are divided by card points. In another embodiment, the sample collection member 60 includes a non-absorbent mesh strip having a void volume.

[0062] Therefore, the shell 10 includes an expansion mechanism 40, which is operable to move the sample collection member 60 between a retracted position and an expanded position, wherein, in the retracted position, the shell 10 encloses the sample collection member 60, and in the expanded position, the sample collection member 60 protrudes from the shell 10 to be inserted into the nasal cavity for collecting nasal secretion samples.

[0063] The proximal end 62 of the sample collection member 60 is connected to the handle 41. Figures 1 to 3 In the embodiment of the present invention, the handle 41 includes a support member 50 for connecting the sample collection member 60 to the handle 41. The support member 50 is fixed to the annular wall 43 surrounding the annular opening 42. The support member 50 includes a longitudinal recess 52 for receiving the proximal end 62 of the sample collection member 60 and securely retaining it therein. The support member 50 is preferably formed integrally with the annular wall 43 of the handle 41. In use, the support member 50 is sized to be received in the hole 22 in the end wall 20 of the housing 10.

[0064] like Figure 1 and Figure 2 As shown, the sample collection member 60 is completely located within the central cavity 30 of the housing 10, which is referred to herein as the "retracted position". In the retracted position, the handle 41 is located at the proximal end 16 of the housing 10. In use, the handle 41 is moved from the proximal end 16 of the housing 10 to the distal end 18. Movement of the handle 41 to the distal end 18 of the housing 10 moves the sample collection member 60 from the central cavity 30, through the hole 22 in the end wall 20 and substantially out of the housing 10. Figure 3 and Figure 4 As shown, when the handle 41 reaches the distal end 18 and cannot move any 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 in the hole 22 in the end wall 20 of the housing 10. In an embodiment, the device 1 may include a mechanism for releasably holding the handle 41 and the sample collection member 60 in the deployed position.

[0065] When in the deployed position, the sample collection member 60 is adapted to collect a sample of respiratory secretions. Preferably, the sample collection member 60 is deployed directly into the patient's nasal cavity to minimize sample contamination. Preferably, the sample collection member 60 is sized to fit comfortably in smaller nostrils and allow sampling of different age groups. The user can control the speed at which the handle 41 is moved to deploy the sample collection member 60 to reduce patient discomfort that may be caused by abrupt insertion of the sample collection member 60, particularly when the patient suffers from a deviated septum or polyps.

[0066] The sample collection member 60 preferably includes a visual volume indicator device, such as a dye indicator. The visual volume indicator is responsive to when a predetermined volume of nasal secretions is collected by the sample collection member 60 to provide a visual indication during or after sample collection. The visual volume indicator is selected from the group consisting of polymer beads, peroxide or oxidation reaction, colorless dye, food dye, and a change in the refractive index of a material.

[0067] After the sample is 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. In this way, the sample collection member 60 is pulled back through the hole 22 in the end wall 20 of the housing 10 until the sample collection member 60 is fully located in the central cavity 30 of the housing 10, which is referred to herein as the "retracted position".

[0068] The hole 22 is surrounded by the end wall 20, and when the sample collection member 60 contains no more than a predetermined volume of sample, its cross-sectional dimension is equal to the cross-sectional dimension of the sample collection member 60. Since the sample collection member 60 may expand after absorbing the sample, the cross-sectional dimension of the hole 22 may be slightly larger than the cross-sectional dimension of the unused sample collection member 60. However, there is a relatively strict tolerance between the cross-sectional dimension of the sample collection member 60 and the cross-sectional dimension of the hole 22. When the sample collection member 60 is pulled out through the hole 22, the end wall 20 surrounding the hole 22 can be operated to wipe off excess sample from the outer surface of the sample collection member 60. Removing excess nasal secretion sample from the sample collection member 60 is beneficial to maintaining volume control, thereby maintaining measurement accuracy.

[0069] In order to reduce the instability and degradation of the collected samples, especially when stored at room temperature, the housing 10 of the device 1 preferably includes a desiccant device to dry the samples and maintain low relative humidity. Alternatively, the housing 10 is adapted to be placed in a container containing a desiccant device to dry the samples and maintain low relative humidity. The desiccant device is preferably silica gel, calcium oxide, calcium sulfate, montmorillonite or other suitable device. Alternatively, the collected samples are stored in a buffer solution or refrigerated for same-day use, or lyophilized or frozen for long-term use.

[0070] The above further embodiment of the present invention includes the above Figures 1 to 6 The same or equivalent features are described in the embodiments of the present invention. The same features are described in the same terms. For the sake of brevity, only the above-mentioned further embodiments of the present invention that are similar in form and / or function to the above-mentioned further embodiments are described in detail below. Figures 1 to 6 The embodiments have significantly different features.

[0071] exist Figure 7 and Figure 8In the embodiment, the device 101 includes a housing 110 having a proximal end 116 and a distal end 118 and parallel and spaced apart wall members 112, 114 defining a central cavity 130. In this embodiment, the wall members 112, 114 include a set of outwardly extending wings 121, 124, which are located toward the distal end 118. The distal end 118 of the housing 110 includes an elongated nose 180 and a set of additional winglets 126, 128. At least a portion of the nose 180 can be inserted into the patient's nose or throat.

[0072] The central cavity 130 accommodates the deployment mechanism 140, which includes a handle 141, a support member 150, and a sample collection member 160. The end wall 120 includes a hole 122 for wiping excess sample from the sample collection member 160, and the end wall 120 is located at the distal end of the elongated nose 180. Figure 7 As shown, the sample collection member 160 is in a retracted position, wherein the sample collection member 160 is completely located within the central cavity 130 of the housing 110. In use, the handle 141 is moved toward the distal end 118 of the housing 110 to deploy the sample collection member 160 from the elongated nose 180 through the aperture 122 to the deployed position. Once the nasal secretion sample is collected, the sample collection member 160 is retracted through the aperture 122 to the retracted position, thereby wiping excess nasal secretions from the sample collection member 160 through the end wall 120 surrounding the aperture 122.

[0073] Fig. 9 and Fig.10 as well as Fig.11 and Fig.12 The embodiments shown differ in the configuration of the deployment mechanism. Fig. 9 and Fig.10 In the embodiment of the device 201 shown in FIG. 2 , the deployment mechanism 240 includes rollers 248 . The wall members 212 , 214 of the housing 210 are configured to completely enclose the central cavity 230 together. Fig.10 The device 201 is shown with one of the wall members 214 removed to expose the interior cavity 230 and the support handle 250. In use, the sample collection member 260 is deployed by manually rotating the roller 248. The support member 250 handle has a set of linear teeth 251 that mesh with a set of teeth 249 provided around the circumference of the roller 248. When the roller 248 is rotated in the opposite direction, the sample collection member 260 is retracted into the housing 210, thereby wiping excess nasal secretions from the sample collection member 260 through the end wall 220 surrounding the aperture 222.

[0074] refer to Fig.11 and Fig.12In the embodiment of the device 301 shown, the handle 341 of the deployment mechanism 340 includes a pair of opposed solid gripping surfaces 342a, 342b configured to be gripped by the thumb and index finger of the user. The wall members 312, 314 of the housing 310 are configured to come together to substantially completely enclose the central cavity 330. The user grips the gripping surfaces 342a, 342b to slide the handle 341 through the wall members 312, 314 along the elongated linear openings 326, 328. The gripping surfaces 342a, 342b of the handle 341 are coupled to the support member 350 located within the cavity 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 to slide the handle 341 to the distal end 318 of the housing 310, the sample collection member 360 is deployed. The sample collection member 360 is retracted by sliding the handle 341 from the distal end 318 to the proximal end 316 of the housing 310. The retracted sample collection member 360 is pulled out through the aperture 322, thereby wiping excess nasal secretions from the sample collection member 360 through the end wall 320 surrounding the aperture 322.

[0075] Fig.13 One embodiment of a device 401 is shown that includes a sample collection member 460, a handle 441, and an elongated support member 450 extending between the handle 441 and the sample collection member 460. The elongated support member includes a hole (430) at a distal end 418 thereof for receiving the sample collection member therein, wherein at least one side of the sample collection member is exposed to contact nasal tissue.

[0076] The elongated support member 450 extends from the handle 441 at a proximal end 416 and extends to a distal end 418, which includes a distal tapered portion 413 for insertion into the nasal cavity. The elongated member 450 also includes a proximal tapered portion 415 adjacent to the handle 441 to limit the extent to which the device 401 can be inserted into the nasal cavity.

[0077] In use, the user grasps the handle 441 and inserts the distal end 418 into the nasal cavity, which brings the sample collection member 460 into contact with tissue at a target location within the nasal cavity, where the sample collection member 460 collects a predetermined volume of nasal secretion sample.

[0078] Fig.14An embodiment of a device 501 including a sample collection member 560 is shown, wherein an elongated support member 550 includes a pair of arms 552, 554, each arm supporting a respective sample collection member 560 at its distal end. A handle 541 includes a pair of gripping members 542, 544 at the proximal ends of the arms 552, 554 and a pair of frame members 555, 556 at the distal ends of the arms 552, 554 for supporting the sample collection member 560. The device 501 is operable so that the gripping members 542, 544 are manually closed together to close the sample collection member 560 together for insertion into a nasal cavity. When the sample collection member is in the nasal cavity, upon releasing the gripping members 542, 544, the sample collection member 560 is biased apart to contact nasal tissue.

[0079] Frame members 555, 556 at the distal ends of arms 552, 554 include distal tapered ends 513, 514 for insertion into the nasal cavity. Elongated member 550 also includes a proximal tapered portion 515 proximate handle 541 to limit the extent to which device 501 can be inserted into the nasal cavity.

[0080] During use, the user holds the gripping members 542, 544 of the handle 541 and inserts the distal end 518 into the nasal cavity, and by inserting the two arms 552, 554 into a single nostril or into both nostrils at the same time, the sample collecting member 560 is brought into contact with the tissue at the target position in the nasal cavity, wherein the sample collecting member 560 collects a predetermined volume of nasal secretion sample.

[0081] Figure 15 to Figure 16 An embodiment of a device 601 is shown that includes a sample collecting member 660, a handle 641, and an elongated support member 650 extending between the handle 641 and the sample collecting member 660. A pair of pivoting frame members 655, 656 are located toward the distal end 618 of the elongated support member 650. Each pivoting frame member 655, 656 supports at least a portion of one or more sample collecting members 660.

[0082] exist Fig.15 and Fig.16 In the illustrated embodiment, the elongated sample collection member 660 passes through the aperture 612 at the distal end 618 of the elongated support member 650. Portions of the sample collection member 660 are supported by a pair of pivoting frame members 655, 656. The ends of the sample collection member 660 are secured to the elongated support member 650, proximate to the pivoting frame members 655, 656, or otherwise secured to the pivoting frame members 655, 656 themselves, such as using adhesives or mechanical attachments.

[0083] The pivoting frame members 655, 656 have an arcuate shape and are connected to the elongated support member 650 at the pivot connection 657. Thus, the pivoting frame members 655, 656 can move relative to each other between an open position and a closed position. In the embodiment shown in the figures, the pivoting movement of the frame members 655, 656 is achieved by the elastic flexibility characteristics of the material forming the frame members 655, 656. However, in other embodiments, the pivoting movement is achieved by a hinge mechanism and a biasing device.

[0084] The frame members 655, 656 are biased toward an open position, and wherein, upon insertion into a nasal cavity, the frame members 655, 656 and one or more sample collection members 660 supported thereon come into contact with nasal tissue and are thereby urged toward a closed position.

[0085] Figures 17 to 20 An embodiment of a device 701 is shown that includes a sample collection member 760, a handle 741, and an elongated support member 750 extending between the handle 741 and the sample collection member 760. One or more expandable frame members 755, 756 are positioned toward the distal end of the elongated support member 750. Each expandable frame member 755, 756 supports at least a portion of the one or more sample collection members 760.

[0086] The frame members 755, 756 are located in one or more channels or recesses 762 within the elongated support member 750 toward its distal end 718. The frame members 755, 756 are located in channels or recesses 762, 764 on opposite sides of the elongated support member 750 toward its distal end 718 and facing away from each other.

[0087] exist Figures 17 to 20 In the embodiment of the present invention, the elongated sample collection member 760 passes through the hole 712 at the distal end 718 of the elongated support member 750. The 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 elongated support member 750 near the proximal ends of the frame members 755, 756, or are otherwise fixed to the frame members 755, 756 themselves, such as using adhesives or mechanical attachments.

[0088] In one embodiment, the expanded frame members 755, 756 have a resting state in which the frame members 755, 756 are closed together, such as Fig.17 and Fig.19 As shown, and having an expanded state, wherein the frame members 755, 756 are separated and opened from each other, as shown Fig.18 and Fig. 20 Therefore, in the static state, Fig.17 and Fig.19As shown, the frame members 755, 756 are flat. Fig.18 and Fig. 20 As shown, frame members 755, 756 are arcuate.

[0089] The device 701 includes a mechanism for selectively expanding or closing the frame members 755, 756. The mechanism includes a pair of manually operable handle members 741, 742 located at the proximal end of the elongated support member 750. The handle members 741, 742 are configured to be manually closed together to open the frame members 755, 756, such as Fig.18 and Fig. 20 As shown, the handle member can be opened manually to close the frame members 755 and 756 together, as shown in FIG. Fig.17 and Fig.19 shown.

[0090] like Fig.19 and Fig. 20 As shown, the elongated support member 750 includes an outer tubular member 751 and an inner tubular member 752. The outer tubular member 751 is connected to the distal end of the handle member 741 at the proximal end 716, and the inner tubular member 752 is connected to the proximal end of the handle member 742 at the proximal end 719. The inner tubular member 752 is slidable within the outer tubular member 751, so that axial movement of the handle members 741, 742 relative to each other causes the inner tubular member 752 to slide axially relative to the outer tubular member 751.

[0091] The frame members 755, 756 include a distal end 753 integrally formed with or connected to the distal end 753 of the inner tubular member 752. The frame members 755, 756 are constructed of a flexible material, preferably also resilient, and are located between the distal end 753 of the inner tubular member 752 and the distal end 754 of the outer tubular 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 together, the inner tubular member 752 slides within the outer tubular member 751, thereby compressing the frame members 755, 756 between the end of the inner tubular member 752 and the distal end of the elongated support member 750. The frame members 755, 756 are thereby forced into an expanded state, wherein the frame members 755, 756 are separated and opened from each other, such as Fig.18 and Fig. 20 shown.

[0093] Conversely, movement of the handle members 741, 742 away from each other causes the inner tubular member 752 to slide in the opposite direction within the outer tubular member 751, thereby eliminating any compressive forces of the frame members 755, 756. The frame members 755, 756 close together due to the elastic properties of the frame members 755, 756 or due to the force applied by the inner tubular member 751, or both. Fig.17 and Fig.19 shown.

[0094] In another embodiment, the expandable frame members 755, 756 have a static state, wherein the frame members 755, 756 are in the expanded state, such as Fig.18 and Fig. 20 Therefore, due to the force applied by the inner tube member 751 or the external force directly applied to the frame members 755, 756, for example, when inserted into the nasal cavity, the frame members 755, 756 are closed together, as shown in FIG. Fig.17 and Fig.19 shown.

[0095] Movement of the handle members 741, 742 away from each other causes the inner tubular member 752 to slide within the outer tubular member 751 to apply a pulling force to force the frame members 755, 756 into a closed position, such as Fig.17 and Fig.19 When the handle members 741 and 742 are released, the expandable frame members 755 and 756 are in an expanded state, as shown in FIG. Fig.18 and Fig. 20 In another embodiment, the device 701 is configured so that the handle members 741, 742 move together to force the frame members 755, 756 into a closed position, such as Fig.17 and Fig.19 shown.

[0096] like Fig.21 As shown in the embodiment, the sheath 800 is suitable for Figures 17 to 20 800 is used together with the device 701 of the present invention. Specifically, the sheath 800 includes a cylindrical tubular member 805, which is closed at a distal end 806 and is open at a proximal end 804. The tubular member 805 is adapted to receive the elongated support member 750 of the device 701 through the opening at the proximal end 804. The tubular member 805 includes a cylindrical wall 802, which includes a plurality of holes 807, allowing air flow through the wall 802. The air flow through the wall 802 of the tubular member 805 allows the sample contained in the collection member 760 to be air-dried, while also protecting the sample.

[0097] Fig.21 Embodiments of the sheath 800 may also be configured with Fig.13 and Figures 15 to 20 Devices 401, 601 and 701 are used together.

[0098] In use, embodiments of devices 1, 101, 201, 301, 401, 501, and 701 can be used to collect a predetermined volume of nasal secretion sample previously collected from a patient, the nasal secretion sample being located in a container or another suitable vessel. The user can deploy the sample collection member 60, 160, 260, 360 into the nasal secretion collected in a container or tube or absorbed into an absorbent material or swab. Thus, devices 1, 101, 201, 301 can be used to collect an accurate volume of sample from a certain amount of sample collected from a patient and place it in a container or other absorbent material or swab to ensure measurement accuracy.

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

Claims

1. A device for collecting nasal secretion samples, the device comprising: a sample collection member comprising a material for collecting a predetermined volume of a nasal secretion sample; handle; as well as an elongated support member extending between the handle and the sample collection member and configured to support the sample collection member; The device is suitable for a user to hold the handle to position the sample collection member at a target position in the nasal cavity to contact the tissue, and the sample collection member collects a predetermined volume of nasal secretion sample at the target position.

2. The device according to claim 1, wherein: The sample collection member includes an absorbent material suitable for absorbing the nasal secretion sample.

3. The device according to claim 1, wherein: The sample collecting member includes a length of absorbent material having one or more points for isolating a portion of the absorbent material to adjust a predetermined absorbent volume of the sample collecting member.

4. The device according to claim 1, wherein: The sample collection member comprises a non-absorbent mesh strip including a void volume for retaining the nasal secretion sample.

5. The device according to claim 1, wherein: The sample collecting member is configured to collect nasal secretion samples within a minimum volume range and a maximum volume range.

6. The device according to claim 1, wherein: The sample collection member includes a visual indicator that provides a visual indication in response to a predetermined volume of nasal secretions being collected by the sample collection member.

7. The device according to claim 6, wherein: Visual volume indicators include dye indicators.

8. The device of claim 1, further comprising a deployment mechanism operable to move the sample collection member between a retracted position and a deployed position, wherein In the retracted position the sample collection member is enclosed within the housing, and in the deployed position the sample collection member protrudes from the housing to be inserted into a nasal cavity for collecting a nasal secretion sample.

9. The device according to claim 8, wherein: The deployment mechanism includes a manually operable base member connected to the sample collection member via the support member, wherein the base member is movable relative to the housing to move the sample collection member between the retracted position and the deployed position.

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

11. The device according to claim 10, wherein: The excess sample removal device includes a wiper for contacting a surface of the sample collection member when the sample collection member moves from the deployed position to the retracted position to wipe excess nasal secretion sample from the surface.

12. The device according to claim 11, wherein The wiper includes a wall surrounding a hole, the cross-section of the hole having a size equivalent to the cross-section of the sample collection member, the sample collection member containing a sample not exceeding the predetermined volume, so that when the sample collection member is pulled out through the hole, excess sample is wiped off the surface of the sample collection member.

13. The device according to claim 1, wherein: In the deployed position, the sample collection member protrudes from the housing to contact a nasal secretion sample collected in a container or 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 to dry the sample and maintain 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 includes a hole at a distal end thereof for receiving the sample collecting member therein, wherein at least one side of the sample collecting member is exposed to contact nasal tissue.

17. The device according to claim 1, wherein: The elongated support member comprises a pair of arms, each arm supporting a respective sample collection member at a distal end thereof, wherein the handle comprises a pair of gripping members at proximal ends of the arms, wherein manually closing the gripping members together causes the sample collection members to close together for insertion into one nostril or into both nostrils simultaneously.

18. The device according to claim 17, wherein: When the sample collection member is located in the nasal cavity, the sample collection member is biased apart to contact nasal tissue upon release of the gripping member.

19. The device of claim 1, further comprising one or more pivoting frame members positioned toward a distal end of the elongated support member, wherein Each pivoting frame member supports at least a portion of one or more of the sample collecting members.

20. The device according to claim 19, wherein The pivoting frame member has an arcuate shape and is pivotally connected to the elongated support member to be movable relative to each other between an open position and a closed position.

21. The device according to claim 20, wherein: The pivoting frame member is biased toward the open position, and wherein, upon insertion into the nasal cavity, the frame member and the one or more sample collection members supported thereon contact the nasal tissue and are thereby urged toward the closed position.

22. The device of claim 1, comprising one or more expandable frame members positioned toward a distal end of the elongated support member, wherein: Each expandable frame member supports at least a portion of one or more of the sample collecting members.

23. The device according to claim 22, wherein: The expandable frame members have a rest state in which the frame members are closed together and an expanded state in which the frame members are opened apart from each other.

24. The device according to claim 23, wherein: In the rest state, the frame member is flat, and in the deployed state, the frame member is curved, and vice versa.

25. The device of claim 23, comprising a mechanism for selectively expanding or closing the frame member, the mechanism comprising a pair of manually operable handle members at the proximal end of the elongated support member, wherein Manually closing the handle members together opens the frame members, and manually opening the handle members closes the frame members, and vice versa.

26. The device according to claim 23, wherein The frame member is biased toward the rest state, and wherein, when inserted into the nasal cavity, the frame member is movable to the deployed state, wherein the frame member and the one or more sample collection members supported thereon are in contact with the nasal tissue.

27. A method for collecting a nasal secretion sample, the method comprising: deploying a sample collection member from a sample collection device into a nasal cavity of a patient; collecting a predetermined volume of nasal secretion sample in the sample collection member; as well as The sample collection member containing the predetermined volume of the nasal secretion sample is retracted into the sample collection device.

28. The method of claim 27, comprising wiping excess nasal secretion sample from the sample collection member during retraction of the sample collection member.

29. The device of claim 27, comprising contacting the deployed sample collection member with a sample of nasal secretions collected in a container or absorbent sample collection material.

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