Sputum collection and cleaning equipment and method of use

Abstract

This medical device is a device (FDA classification: "Sputum Sample [Home] Self-Collection Device" and "In Vitro Medical Diagnostic Device") and method for the self-collection, transportation, purification, and storage of sputum specimens to optimize specimen quality and the reliability of clinical laboratory staining interpretation, culture, and molecular diagnostic testing, thereby improving laboratory support for pathogen-specific treatment (antibiotic stewardship).

Description

Technical Field

[0001] This medical invention is a device (FDA classification: "Sputum Sample [Home] Self-Collection Device" and "In Vitro Medical Diagnostic Device") and method for self-collecting, transporting, cleaning, sampling, and storing coughed sputum samples to optimize the accuracy of clinical diagnostic studies, thereby improving laboratory support for pathogen-specific treatment decisions (antibiotic stewardship). This "sputum cleaning" invention is relevant to current global public health emergencies, including the COVID-19 pandemic, tuberculosis, childhood pneumonia, and microbial antibiotic resistance. Background Art

[0002] Lung infections threaten public health worldwide, accounting for a major portion of doctor visits, hospitalizations, morbidity, mortality, healthcare costs, work-related losses, and overprescription of antibiotics that contribute to the development of microbial resistance to antibiotics. During the current COVID-19 pandemic, millions of people have become ill and hundreds of thousands have died from SARS-CoV-2 infection to date. Millions more suffer and die annually from childhood pneumonia and tuberculosis. Reliable identification of the causative pathogen allows for appropriate treatment, reducing morbidity, mortality, costs, and the risk of pathogen-blind (i.e., contraindicated) antibiotic prescribing.

[0003] A lax but widely used "empiric" treatment for outpatient respiratory infections involves the application of (pathogen-blind) "herd statistics" to individual outpatients, resulting in massive overuse of inappropriate antibiotics.

[0004] Appropriate treatment requires the timely identification of the correct pathogen in each patient's case. Reliable sputum examination is the only way to directly identify pathogens in the lower respiratory tract, thereby enabling appropriate clinical treatment decisions (antibiotic stewardship).

[0005] A traditional laboratory method for identifying respiratory pathogens is the "Gram stain" of a sample of sputum (mucus secreted by the "goblet" cells of the bronchial epithelium). Sputum is usually sterile; Gram staining of infected "subglottic" (uncontaminated) sputum reliably identifies bacterial pathogens. However, subglottic sputum sampling requires an invasive procedure (tracheal aspiration or intubation) and is therefore rarely used for outpatient sample collection.

[0006] Therefore, Gram stains are most commonly performed on "cough" specimens (sputum expectorated subglottically and expectorated into a container). Because the non-sterile oropharynx is typically populated by a large salivary microbial flora, the expectorated bolus becomes contaminated as it passes through the mouth. Both Gram staining and culture of such contaminated (unwashed) specimens often (up to 50%) fail to identify the masked pathogen, leading many clinicians to consider (unwashed) sputum studies unreliable and therefore "irrelevant" to treatment decisions. Infectious disease consensus guidelines currently consider sputum studies to be "optional" for empiric treatment of outpatients, rather than the best choice for pathogen-specific antibiotic stewardship.

[0007] Therefore, current outpatient lung infection treatment is pathogen-blind, encourages antibiotic overuse, and accelerates the phenomenon of microbial antibiotic resistance (currently a global public health emergency).

[0008] "Cleansing" sputum, which is free of salivary microflora, significantly improves laboratory staining, culture, and molecular testing results. Saliva contaminants in expectorated sputum pellets are water-soluble; sputum is not. "Washing" the sputum pellet with water or saline dilutes and removes these soluble contaminants, improving the specimen's quality ("Bartlett criteria"). The sensitivity and specificity of all diagnostic studies are improved by sputum washing; even currently unacceptable (unwashed) pellets are converted to "Bartlett quality" (average <<10 SEC / LPF) specimens for reliable testing.

[0009] Previous "sputum washing" techniques have not been accepted in clinical practice. Manual research techniques (e.g., stirring the pellet in water; tea strainers) have not evolved into an acceptable practice in over 125 years. The present device and method are designed to facilitate user-friendly self-collection, transportation, pre-analysis cleanup, sampling, and storage protection of sputum pellet samples.

[0010] An object of the present invention is to facilitate the self-collection of cough samples by outpatients without the need for inpatient "medical supervision." The device is user-friendly for the patient, with a wide-mouthed target, a textured ergonomic gripping surface, and a secure, leak-free screw-top cap with a write-on identification label surface. Maintaining a safe distance from others during coughing can be accomplished through simple illustrated patient instructions. By using the present invention to cleanse (decontaminate) the coughed sputum pellet prior to testing, any concerns that "unsupervised" sputum collection might reduce sample quality are completely alleviated. Because outpatients (with a licensed provider application) may submit samples prior to their appointment, "unsupervised self-collection" of coughed sputum samples can provide outpatients with pathogen-specific antibiotic stewardship, which is necessary to reverse the single largest cause of the current global microbial antibiotic resistance emergency (pathogen-blind empirical antibiotic overuse).

[0011] Another object of the present invention is to provide a secure enclosure for potentially biohazardous sputum samples for transport from self-collection sites to clinical testing sites and subsequent storage. This GMP-compliant device design is leak-proof and resistant to breakage. It is compatible with 6-inch pneumatic transport systems. Purification and refrigerated storage maintain sample quality in the same multifunctional device used for self-collection and transport.

[0012] Another object of the present invention is to provide a device that facilitates reliable, timely, and economical removal of oropharyngeal contaminants from a cough bolus sample by washing the bolus sample in water or saline.

[0013] Another object of the present invention is to improve sample collection for clinical diagnostic studies, including staining, culture, and molecular (nucleic acid) testing. A specially designed sputum-adherent "grabber" brush tool (hereinafter referred to as the "grabber tool") is incorporated for user-friendly, clean sample collection from the ring plate at the apex of the conical mesh. Mucus "cutter" grooves are incorporated into the "sputum retention barrier" to reduce the size of the "grabbed" sample when needed. The grabber tool also improves the uniformity of sample application (spreading) on ​​the microscope slide compared to the traditional "microbiology ring."

[0014] Another object of the method of the present invention is to maintain the quality of the expectorated sample for storage and further testing. Contaminating microorganisms in saliva multiply at an exponential rate, multiplying once every 20 minutes. Therefore, over time, the quality of expectorated sputum (according to the Bartlett criteria) will rapidly decline. It is recommended to clean the expectorated sputum mass sample as soon as possible to remove the contaminated saliva microorganisms before they multiply. The purified sample can then be studied and / or stored for subsequent testing (and / or re-cleaned), as shown.

[0015] It is therefore an object of the present invention to improve the cost-effectiveness of diagnostic sputum testing by optimizing the self-collection, transportation, cleansing, sampling and storage preservation of expectorated sputum samples in a single user-friendly multifunctional device / apparatus.

[0016] The sputum studies optimized by the present invention must be requested by licensed clinical providers in most healthcare systems (e.g., Medicare). Another object of the present invention is to empower a paradigm shift in medical practice—from pathogen-blind, "empirical" treatment of respiratory tract infections in outpatients—by empowering pathogen-specific antibiotic stewardship. This paradigm shift is foreshadowed by the successful resolution of four current public health emergencies worldwide.

[0017] In the following description, the device of the present invention, including all its different embodiments, is referred to as a "sputum cleaner"; the method of the present invention is referred to as a "sputum cleaning" Summary of the Invention

[0018] Disclosed are a medical device (which may qualify under FDA classifications: "Sputum Sample [Home] Self-Collection Device" and "In Vitro Medical Diagnostic Device") and methods for the self-collection, transport, purification, sampling, and storage of sputum samples to optimize the reliability of clinical diagnostic tests, thereby improving laboratory support for pathogen-specific treatment decisions (antibiotic stewardship).

[0019] In one embodiment, the sputum cleaner of the present invention includes a transparent container having an opening at a top end, a mesh assembly positioned within the container and above a bottom end of the container, and a removable cover for sealingly engaging the top end of the container. The mesh assembly includes a mesh flange (mesh retainer) connected to the mesh and coupled to the sidewall of the container. The flange includes a decanting port located between the mesh and the sidewall of the container for discharging cleaning fluid from the container opening after cleaning.

[0020] In one embodiment, the method of the present invention includes collecting a sputum sample into a mesh area, filling a container to the fill line with a saliva-dissolving washing fluid (e.g., saline or tap water), sealing the container with a removable lid to create a watertight seal, agitating the sputum sample in the container for a predetermined duration (approximately 5 seconds), removing the lid, and draining the washing fluid from an opening in the top of the container via a decanting port of the mesh assembly.

[0021] In another alternative embodiment, the sputum washer includes two openings (one at the top and one at the bottom of the container), two removable covers (a top cover and a bottom cover), and a mesh cone assembly without a decanting port.

[0022] In another alternative embodiment, the sputum cleaner includes two openings (one at the top and one at the bottom of the container) (a "dual-opening sputum cleaner"), a mesh cone assembly without a decanting port, and three removable caps (two optional caps for sealing the container from the top and one cap for sealing the container from the bottom). One of the top caps incorporates a suction port.

[0023] For example, in one embodiment, the apparatus of the present invention includes: (a) a container having a top end, a bottom end, a peripheral sidewall, and an opening at the top end; (b) a mesh cone positioned within the container opening and above the bottom end, the mesh cone being configured to support a sputum sample and further configured to allow passage of a cleaning fluid; (c) a flange supporting and coupling a mesh to the peripheral sidewall of the container, the flange having a decanting port located between the mesh and the peripheral sidewall; and (d) a removable lid configured to seal the container opening, wherein the flange and the removable lid are configured to form a (sputum retaining) barrier between the mesh and the decanting port that is capable of blocking passage of the sputum sample through the barrier during cleaning and cleaning decanting. The peripheral sidewall may include a fill line ("cleaning line") for the cleaning fluid.

[0024] The removable lid can be fixed to the container via a threaded connection. The lower surface of the removable lid includes a first circumferential rib so that when the rib is pressed against the flange, the above-mentioned (phlegm-retaining) barrier is generated. The lower surface of the removable lid can include a second circumferential rib having a larger diameter than the first circumferential rib, the second circumferential rib being configured to enhance the seal of the container when the second circumferential rib is pressed against the flange.

[0025] The flange may further include a protrusion above the mesh that is configured to prevent the sputum sample from being discarded during the discharge of the cleaning fluid through the decanting port and out of the container opening at the top of the container. The edge of the protrusion has a V-shaped profile to facilitate cutting the cleaned sample (limiting sample size) during removal from the mesh cone ring plate.

[0026] The sputum cleaner of the present invention may further include a grabber tool to enable manual removal (sampling) of the cleaned sample from the ring plate. The grabber tool is configured to be received in the decanting port within the container cleaning area.

[0027] In one embodiment of the invention, the mesh is conical and includes a sampling plate ("ring plate") at the apex of the cone, or the sampling plate may completely replace the mesh material at the apex of the cone.

[0028] In an alternative embodiment of the present invention, the sputum washer device includes (a) a container having a top end with a first opening, a bottom end with a second opening, and a peripheral sidewall between the top end and the bottom end; (b) a mesh cone positioned within the container and above the bottom end, the mesh cone being configured to support a sputum sample bolus up to a predetermined amount (e.g., 30 cc) and further configured to allow a cleaning fluid to pass therethrough, the mesh cone further including a sampling or "ring plate"; (c) a flange supporting the mesh and coupling it to the peripheral sidewall; (d) a first removable cover being configured to form a watertight seal at the first opening after the sputum sample bolus is deposited into the mesh area; and (e) a second removable cover being configured to form a watertight seal at the second opening and further configured to be removed for discharge of the cleaning fluid from the container through the second opening, wherein the device provides for cleaning of the sample and discharge of the cleaning fluid.

[0029] The present invention also includes a novel method for self-collecting, transporting, purifying, sampling and storing cleaned sputum samples. For example, in one embodiment, the method includes the following steps:

[0030] (a) providing a device comprising

[0031] (i) a container having a top end, a bottom end, a peripheral sidewall, and an opening at the top end; (ii) a mesh cone positioned within the opening and above the bottom end, the mesh cone being configured to retain a sputum sample and further configured to allow passage of a cleaning fluid; (iii) a flange supporting the mesh and coupling it to the peripheral sidewall, the flange having a decanting port located between the mesh cone and the peripheral sidewall; and (iv) a removable cover;

[0032] (b) depositing a sputum sample onto the mesh area (i.e., onto the mesh or a sampling plate at the bottom of the mesh); (c) sealing the container with a removable lid, wherein the flange and the removable lid cooperate to form a barrier between the mesh and the decanting port (at the upper surface of the flange) that is capable of restricting passage of the sample through the barrier; (d) agitating the sample in the presence of a cleaning fluid to dilute and dissolve contaminants from the sample clump; (e) opening the container; and (f) draining the cleaning fluid from the container through the decanting port and out of the container opening. In the methods of the present invention, the agitation or tumbling step can be performed for a predetermined duration (e.g., approximately 5 seconds).

[0033] The method of the present invention may further comprise the step of removing the grabber tool from its storage position via the decanting port upon arrival at the laboratory and after removal of the cover.

[0034] The method of the present invention may further include the step of manually sampling (removing a portion) the cleaned sample from the mesh cone ring plate in the container using a grabber tool. The method may further include reducing the size of the sample by dragging the sample through a cut groove on the sample retaining barrier of the flange. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] The accompanying drawings, together with the following detailed description, are incorporated in and form a part of the specification and are used to further illustrate embodiments of the concepts of the claimed invention and to explain the various principles and advantages of these embodiments, wherein like reference numerals refer to identical or functionally similar elements throughout the various views.

[0036] Figure 1 An embodiment of the sputum washer device of the present invention is shown.

[0037] Figure 2 Shown Figure 1 Exploded view of the device.

[0038] Figure 3 It is a cross-sectional view of the device of the present invention.

[0039] 4(a) - 4(c) depict an embodiment of the sputum cleaner of the present invention with additional details.

[0040] 5(a) - 5(e) are detailed views of an embodiment of a container of a sputum cleaner of the present invention.

[0041] 6( a )-6 ( e ) are detailed views of an embodiment of a mesh cone assembly with a top sampling plate of a sputum cleaner of the present invention.

[0042] 7(a) - 7(e) are detailed views of an embodiment of a removable cover of a sputum washer of the present invention.

[0043] 8(a) - 8(e) are detailed views of an embodiment of a grasper tool of the sputum cleaner of the present invention.

[0044] Figure 9 An embodiment of the method for self-collection of sputum by coughing up is disclosed.

[0045] Figure 10 An embodiment of the method for sputum cleaning of the present invention is disclosed.

[0046] Figure 11 A second embodiment of the apparatus of the present invention is disclosed.

[0047] Figure 12 A third embodiment of the apparatus of the present invention is disclosed.

[0048] Figure 13 Two alternative sputum collection methods of the present invention are disclosed.

[0049] Figure 14 Another embodiment of the method for sputum cleaning of the present invention is disclosed.

[0050] Those skilled in the art will appreciate that the elements in the drawings are shown for simplicity and clarity and are not necessarily drawn to scale. For example, the sizes of some elements in the drawings may be exaggerated relative to other elements to help improve understanding of the embodiments of the present invention.

[0051] In the drawings, apparatus and method components are represented by conventional symbols where appropriate, and only those specific details relevant to an understanding of the embodiments of the invention are shown so as not to obscure the disclosure with details that would be readily apparent to one of ordinary skill in the art having the benefit of the description herein. DETAILED DESCRIPTION

[0052] The following detailed description discloses some embodiments of the sputum collection and cleaning device ("sputum cleaner") of the present invention and methods of using the same.

[0053] Figure 1An embodiment of a disposable sputum cleaner device of the present invention is shown. The illustrated sputum cleaner 1 comprises a transparent container 2, a mesh cone assembly 4 located within the container, and a removable lid 6. In addition to having a threaded sidewall inside the periphery (ridge) of the lid (for sealably engaging with external threads at the upper edge of the container's sidewall), the lower surface of the lid comprises two circumferentially extending ridges, namely an inner rib 5 and an outer rib 7, the functions of which are described in detail below. Figure 3 Provide explanation. Figure 1 Also shown is a grabber tool 8 housed within the sputum cleaner 1. The grabber tool 8, the purpose of which will be described further below, is depicted as a component of the sputum cleaner device 1. Its purpose is to facilitate sampling, however, the grabber tool is not necessary for collecting or cleaning a sample using the sputum cleaner of the present invention.

[0054] Figure 2 Depicts Figure 1 , discloses the above-mentioned components in more detail. For example, the container 2 includes a bottom end 10, a top end 12 having an opening 14 therein, and a peripheral side wall 16. The peripheral side wall includes a fill line (cleaning line) 18, the purpose of which will be further explained below. The mesh cone assembly 4 is placed, for example, snap-fitted into the container opening 14 so that it rests on or against a lip or ridge on the interior surface of the peripheral side wall 16. As a result, when the mesh cone assembly 4 is placed in the container 2, it creates a sputum collection area in the container. In alternative embodiments, the mesh cone assembly 4 can be coupled to the interior of the container (by welding or adhesive).

[0055] exist Figure 2 In the illustrated embodiment, the mesh assembly 4 includes a conical mesh 20 supported in the container opening 14 and above the bottom end 10 of the container by a mesh retaining flange ("flange") 22. The mesh cone, which is configured to support a sputum sample, includes perforations sized to substantially prevent the passage of sputum (due to its viscosity) while allowing the passage of a cleaning fluid (e.g., saline or tap water). The mesh is permeable to the cleaning fluid while being relatively impermeable to the sputum. The flange 22 helps to hold and secure (or couple) the mesh 20 in the container. The flange 22 further includes a decanting port 24 that helps to drain (decan) the cleaning fluid from the container. Although in Figure 2 In the embodiment shown, the net 20 and the flange 22 are shown as being integrally connected, but the present invention is not limited thereto, and these components may be separate elements.

[0056] Figure 2 Further shown is the flange 22, which includes a protrusion 28 above the mesh 20. The protrusion forms a barrier that retains the sputum sample in the mesh area during pipetting, thereby preventing accidental loss of the sample. The edge of the protrusion 28 includes features that help cut (limit size) the cleaned sample during removal from the ring plate. Figure 2In the embodiment shown, the feature is a V-shaped groove 30 .

[0057] Figure 2 A removable cover 6 is further shown. Figure 2 In a preferred embodiment of the sputum cleaner, the removable cap 6 includes a threaded sidewall for engaging a set of threads on the outer surface of the sidewall 16 of the container to form a watertight seal between the cap and the container. Figure 2 The embodiments depict threads as the cap-container connection mechanism for creating a watertight seal, but the invention is not limited thereto and contemplates creating a seal by other means, such as a snap fit, a press fit, etc.

[0058] Figure 2 Also shown is a stowed grabber tool 8, designed to facilitate sampling (removing a portion) of a sputum sample from the surface of the mesh or ring plate. The grabber tool includes a brush at its lower end and a proximal handle extending from the brush. In this way, a controlled portion of the cleaned sputum sample can be manually removed from the sputum cleaner of the present invention for laboratory analysis.

[0059] In one embodiment of the present invention, the container 2 and the lid 6 are made of a transparent material, such as plastic or glass, with a fill line and other indicators, such as user instructions, molded or extruded therein. The transparency of the container and lid enhances the overall usability of the sputum washer device and its contents. However, in other embodiments, the container and / or lid may be made of other materials, such as metal. Although Figure 2 The embodiment shown in FIG. 1 shows that the container 2 has a substantially cylindrical shape, but the present invention is not limited thereto, and other shapes such as a rectangle may be used.

[0060] Figure 3 yes Figure 1 2, but the removable cover 6 is shown in sealing engagement with the container 2. The application of the removable cover 6 creates additional internal structure for the sputum washer of the present invention. For example, in addition to providing a watertight seal for the container, Figure 2 Circumferential internal ribs 5 and 7 of the cap are shown engaging the flange 22 on either side of the flange's decanting port 24, with internal rib 5 engaging the flange 22 further from the container's peripheral sidewall 16 than internal rib 7. While both internal ribs 5 and 7 help retain the flange 22 and its attached mesh 20, both internal ribs 5 and 7 serve an additional purpose during cleaning.

[0061] For example, the circumferential inner ribs 5 serve to form a sputum sample retaining barrier on the flange 22 between the mesh 20 and the decanting port 24. Specifically, Figure 3The ribs 5 are shown contacting and pressing against the upper surface of the flange 22 between the mesh 20 and the decanting port 24. In a preferred embodiment, the flange is made of a deformable material, which helps to create a sample retention barrier. Because both the cover 6 and the flange 22 are watertight, the internal ribs 5 and the flange 22 cooperate to form a fluid barrier that prevents the transfer of fluid (sputum and washing fluid) on the upper surface of the flange 22 between the decanting port and the mesh during sputum washing. Although in a preferred embodiment of the present invention, the barrier formed by the internal ribs 5 and the flange 22 is watertight, it is sufficient for the present invention that the barrier is merely sputum-tight. Therefore, having internal ribs that are merely sputum-tight is sufficient to form the disclosed barrier. (Note that regardless of the material used for the internal ribs 5, the removable cover 6 and the flange 22 are both watertight.)

[0062] Although in the embodiment shown, the barrier is formed by the internal ribs 5 of the lid pressing from the top against the flat upper surface of the flange 22, any barrier-forming cooperation between the upper surface of the flange 22 and the lower surface of the lid is sufficient. For example, the internal ribs 5 can be structures extending upward from the upper surface of the flange 22, rather than being part of the lid 6, so as to contact / press against the lid at its lower surface. In another embodiment, the sputum-retaining barrier can be formed by a structure in which the internal ribs of the lid are engaged by a mating structure extending upward from the top surface of the flange, and the ribs of the lid are engaged anywhere (vertically) between the lid and the flange.

[0063] The circumferential internal rib 7 is also shown contacting or pressing against the flange 22. When the flange is made of a soft durometer deformable (ductile) material, the rib 7 creates a further watertight seal for the sputum washer of the present invention in addition to any seal created by the threaded cap-container connection.

[0064] The above components form an arrangement in which a sputum sample deposited on the mesh is retained in the mesh area of ​​the sealed container during cleaning of the sample with a cleaning fluid.

[0065] Figures 4(a) to 4(c) An embodiment of the sputum cleaner of the present invention is depicted through additional detailed views. For example, FIG4(a) is a side view of the sputum cleaner with the lid opened. FIG4(b) depicts a cross-sectional view of the sputum cleaner along line "AA" in FIG4(a). The cross-sectional view of FIG4(b) is similar to FIG4(a). Figure 3 The cross-sectional view of FIG4(b) differs in that it also shows the gripper tool 8 in a stored position within the container, with the top end of the tool protruding from the decantation port 24. FIG4(c) is an enlarged view of area "B" in FIG4(b). For example, FIG4(c) depicts the top end of the gripper tool 8 passing through the decantation port 24 and resting against the circumferential inner rib 7 of the lid 6.

[0066] Figure 5(a)-5(e) The container 2 is shown in more detail. Figure 5(a) is a perspective view of the container, which, in a preferred embodiment, is made of a transparent material such as glass or plastic. The container has a generally cylindrical shape with threads 40 located at the top of the outer sidewall 16. Figure 5(b) is a side view of the container in Figure 5(a), showing the slight outward tilt of the outer sidewall 16 at the top. Figure 5(c) is a cross-sectional view of the container in Figure 5(b) taken along line "AA". The sidewall 16 and the bottom of the container are shown as having a certain thickness and profile. Figure 5(d) is an enlarged view of the outer sidewall 16 in area "B" of Figure 5(c). For example, Figure 5(d) shows threads 40 on the outer surface of the outer sidewall 16, and a lip (protrusion) 42 on the inner surface of the sidewall 16, which is used to support the flange 22 of the mesh assembly 4.

[0067] Figure 6(a)-6(e) 6( a) is a detailed view of a preferred embodiment of the mesh cone assembly 4. FIG. 6( a) is a front view of the mesh assembly. It shows the mesh 20 extending below the flange 22 and the mesh protrusion 28, which in a preferred embodiment also extends upward from the flat portion of the flange 22. The flange is also shown to include downwardly converging protrusions for supporting the mesh 20 from below, thereby allowing the mesh to form a cone shape. The present invention contemplates that the mesh is made of plastic, nylon, stainless steel, or other materials. In alternative embodiments, the mesh can be made of a perforated rigid or semi-rigid material. At the bottom, the mesh cone assembly includes a sampling ring plate 52 for supporting the sputum sample as it slides down the mesh wall after being deposited on the mesh wall. FIG. 6( b) is a side view of the mesh assembly of FIG. 6( a), which provides a detailed view of the protrusion 28.

[0068] FIG6( c ) is a cross-sectional view of the mesh assembly 4 taken along line “AA” in FIG6( b ). The flange 22 is shown having a body 58 (plastic or metal) with an overmolded section 54 along the edge. The overmolded portion of the flange is made of a soft durometer (ductile) material (soft plastic or rubber) that cooperates with the ribs 5 and 7 of the cover 6 to form a retaining barrier and a watertight seal as described above. In addition to the overmolded portion 54, the flange 22 may include an overmolded insert seal 56.

[0069] Figure 6(d) shows a top view of the mesh cone assembly. Figures 6(a)-6(c) In addition to the mesh assembly components discussed, Figure 6(d) also shows the decanting port 24 and the sputum cutter V-shaped groove 30. Figure 6(e) is a perspective view of the mesh assembly 4 showing the components of the mesh cone assembly from different angles.

[0070] Figures 7(a)-7(e) are more detailed views of the removable cover 6 of the sputum cleaner of the present invention from different angles. Figure 7(b) provides a top view of the cover. Reference numeral 70 indicates an area along the outer surface of the cover having a textured surface, which is used to improve manual grip when opening and closing the cover. Figure 7(c) is a side view of the removable cover in Figure 7(a), which depicts the intermittent textured area of ​​the cover from the side. Figure 7(d) is a cross-sectional view of the cover along line "AA" in Figure 7(c). It shows the threaded sidewall 72 of the cover and its circumferential internal ribs 5 and 7 as described above.

[0071] Figure 7(e) is an enlarged view of the cap in area "B" of Figure 7(d). For example, Figure 7(e) shows the internal ribs 7 and the threaded features of the side wall of the cap.

[0072] Figures 8(a)–8(e) provide detailed views of the grabber tool 8. As shown in Figure 8(a), the grabber tool 8 has an eyelet 82 at its top end and a plurality of spikes or brushes 84 at the bottom ("tip") end. Although in a preferred embodiment, the body of the grabber tool is formed of plastic, the present invention contemplates a body of the grabber being formed of other materials such as glass, metal, etc. In a preferred embodiment, the tip end also includes a silicon overmold. Figure 8(b) depicts the grabber tool of Figure 8(a) rotated 90 degrees. Figure 8(c) is a cross-sectional view of the grabber tool along line "AA" in Figure 8(b), showing the overmold capture feature 86. Figure 8(d) is a perspective view of the grabber tool 8, and Figure 8(e) is a detailed view of the tip end of the grabber tool in Figure 8(d), showing the brushes (spikes) and overmold in more detail.

[0073] Figure 9 and Figure 10 Shown above using Figure 1 -7 discloses a single-cover sputum cleaner according to the present invention for collecting and cleaning sputum. For example, Figure 9 "Expectorant" sample collection is shown, and Figure 10 The cleaning of a sputum sample by the single-cap sputum cleaner of the present invention is shown.

[0074] Figure 9 The sputum self-collection method shown can be performed by the patient with or without "medical supervision". The best time to collect is after waking up and before eating. Because the sputum cleaner may be sterile and sealed (see Figure 9), so the sputum collection process begins by unpacking and removing the sputum washer device. The next step is to remove the cap 6 from the sputum washer (the grasper tool 8 should remain housed in the decanting port during sample collection and transport). The outpatient will "blow" their nose and rinse their mouth with tap water, then take a deep breath and cough up sputum from deep in their chest, and then spit the sputum (approximately 5cc) into the wide-mouthed sputum washer collection device. For "medically supervised" inpatients, hypertonic saline nebulization and / or postural percussion can be used to stimulate sputum production (see Figure 9 The next steps are to replace the cover 6 on the container 2, label the sputum cleaner with the patient's name, date and time, and transport the sample to the clinical laboratory as soon as possible (see Figure 9 If there are any delays in transporting the samples to the laboratory, the samples should be refrigerated.

[0075] Figure 10 The sputum cleaning method of the present invention using the single-cap sputum cleaner described above is demonstrated (in a CLA-certified clinical laboratory under a biohazard hood with universal infection precautions). Figure 10 The sputum cleaning process in the sputum cleaning process starts by removing the cover 6 from the container (see Figure 10 (A) in the figure). Remove the grabber tool from the pipetting port. The next step is to fill the container with a saliva-dissolving cleaning fluid (such as water or saline) to the fill line 18 (see Figure 10 The next step is to replace the cover 6, thereby sealing the sputum sample and washing fluid within the device (see Figure 10 The device is then manually flipped / rolled (i.e., agitated) for a predetermined duration (e.g., approximately 5 seconds) to expose the sputum bolus to the washing fluid in order to dilute and dissolve salivary contaminants from the sample bolus (see Figure 10 In the next step of the method of the present invention, the cap 6 is removed and the cleaning fluid containing the dissolved contaminants is poured out from the opening 14 at the top of the decanting port 24 and 2 (see Figure 10 Once the sputum sample has been cleaned, it can be removed from the mesh or ring plate using a grasper tool for Gram staining (Bartlett's test) or other diagnostic testing procedures (see Figure 10 Samples can also be placed in petri dishes for incubation and culture testing, or in test tubes for molecular testing.

[0076] Additionally, the sputum cutting feature of the sputum cleaner of the present invention (in a preferred embodiment, the sputum cutting feature is located on a flange protrusion, but may be located at another location on the flange, or on the container itself) may be used to cut or confine the sample (reducing the size of the sample attached to the grabber brush). Alternatively, sampling of the cleaned sputum sample may be performed from the plate using a loop or pipette.

[0077] Traditionally, a Gram stain "Bartlett score" is performed to assess sputum quality for diagnostic testing. In a preferred embodiment, a sample is rejected for testing if the score is greater than the mean of 10 buccal SEC / HPF (10 buccal SEC / HPF) in 25 selected LP domains. However, the sputum washing procedure of the present invention "rescues" (improves the Bartlett score) such contaminated (low-quality) clumps, converting them into reliable samples for research (rather than the current practice of discarding them when the laboratory requires better repeat samples). Once the washed sample is purified, it can be sampled or refrigerated for future testing. Depending on the storage duration (usually about 5 days), the washing procedure may be repeated at a later time. When the sample is no longer needed, the sputum washer device can be disposed of in accordance with CLIA biohazardous waste management protocols.

[0078] Figure 11 An alternative embodiment of the sputum cleaner of the present invention is shown. Figure 1 -The sputum cleaner disclosed in 8, Figure 11 The sputum cleaner in the embodiment of the present invention further comprises a container 90, a mesh assembly 92 located within the container, and a removable cover 94 at the top of the container. Figure 1 -8, which includes an opening only at the top end of the container, the container 90 also includes an opening at its bottom end for draining the cleaning fluid. Figure 11 The sputum washer embodiment in the present invention includes not only a removable cover 94 at the top of the device ("top cover"), but also a removable cover 96 at the bottom ("bottom cover"). The fact that the bottom cover 96 can be removed allows for simultaneous cleaning of the sputum sample and discarding of the cleaning fluid through the bottom opening of the container. Figure 11 The mesh assembly 92 of the sputum cleaner is also partially different from Figure 1 -8 in the mesh assembly 4 (wherein the cleaning fluid is discharged / decanted from the top opening of the container). Therefore, although including Figure 1 -8 embodiment disclosed mesh components similar to the mesh, but the flange of the mesh assembly 92 does not need to include Figure 1 -8 sputum washer decanting port 24 or protrusion 28. Therefore, the flange of the mesh assembly 92 can be of a very simple and inexpensive design, the purpose of which is only to connect and fix the mesh component to the interior of the container 90. Similar to Figure 1-8, the container 90 includes an internal lip or ridge to receive and secure the net assembly 92, such as by a snap or other type of attachment mechanism. Figure 1 -8, the net assembly 92 may further include a plate, referred to in the art as a "ring plate", for sampling at the bottom of the net. Compared to the prior art, Figure 11 The dual-cap sputum wash embodiment in simplifies the overall design, improves reliability, and reduces sample rejection rates, costs, and time to results. One purpose of this self-collected sputum wash invention is to enhance outpatient pathogen-specific antibiotic stewardship by reliably identifying the causative pathogen before "time of service" when provider treatment decisions are made. For example: when an outpatient appointment is made with "fever and cough" symptoms, the provider can request a sputum wash test and provide results before the appointment date. This will require provider education and incentives (a paradigm shift in standard of care) to favor pathogen identification over an empirical (pathogen-blind) approach when treating outpatient respiratory infections.

[0079] Figure 12 Depicts Figure 11 A modified embodiment of the sputum washer device of the present invention. Specifically, Figure 12 Sputum cleaner and Figure 11 The embodiment in is different in that, in addition to the removable top cover 94, it also includes a second removable top cover 101, hereinafter referred to as the "non-suction top cover" and the "suction top cover", respectively. Unlike the non-suction top cover 94, the suction top cover 101 includes two suction ports: a vacuum port 103 and a patient suction port 105. The patient suction port 105 can extend (107) below the inner surface of the suction top cover, and once the suction top cover is applied (screwed, snapped, etc.) to the container 90, the extension 107 will extend into the interior of the container 90, above the mesh cone. Including the "suction top" cover 101 as an optional component of the sputum cleaner allows for an alternative (vacuum suction assisted) method of sputum collection, thereby simplifying the device design, which is superior to the prior art and serves multiple sample collection scenarios, such as Figure 11 implemented.

[0080] Figure 11 and 12 Embodiments of the sputum cleaner allow for different methods of sputum sample collection and cleaning. Figure 13 This difference is shown in the context of sample collection.

[0081] like Figure 13 As shown, sample collection can be accomplished via two different routes: Figure 13 The "Expectorant" route for self-collection is shown on the right side of Figure 13 The medically supervised "suction capture" approach on the left. Figure 11 The sputum cleaner embodiment can only be used for the "expectoration" route, but Figure 12 The sputum washer embodiment can be used for either route. Figure 13 The "expectoration" pathway in Figure 9 The "expectoration" pathway described in .

[0082] However, the “suction and capture” pathway differs from the “expectoration” pathway in the number of steps. Figure 13 As shown on the left side, the "suction capture" path is also opened from the Figure 12 The packaging of the sputum cleaner begins. If the sputum cleaner comes with a "non-suction top cover" 94, the cover 94 is removed but retained. Instead, the suction top cover 101 is attached to the top of the container. Next, the vacuum suction source tubing is attached to the suction port 103 of the cover 101. The catheter, trocar or observation tube is attached to the patient port 105 of the cover 101. This is shown in Figure 13 Next, the patient is suctioned (according to the clinical protocol) to obtain sputum and deposited on the mesh 92 of the device. Next, the suction top cover 101 is removed and discarded, while the non-suction top cover 94 is reapplied to the container 90. Next, the sputum cleaner (i.e., the sample) is labeled with the patient's name, date, and time. The sample should be transported to the clinical laboratory as soon as possible (see Figure 13 (The vacuum source tubing, patient attachment tubing, and labeling are optional components of the sputum cleaner of the present invention.) If the grasper tool 8 has been previously removed from its packaging, it can be placed in the container before closing the lid and labeling the sample. If there are any delays in transporting the sample to the laboratory, the sample can be refrigerated in the device.

[0083] Figure 14 Publicly disclosed in Figure 13 After collecting the samples, the Figure 11 and 12 The cleaning method of the sputum cleaner embodiment disclosed in. Figure 14 The sputum cleaning process in the apparatus begins by removing the top cover 94 and the bottom cover 96. In a preferred embodiment, the bottom cover 96 is removed first, followed by the top cover 94 (see FIG. Figure 14 ). However, the order of these steps can be reversed. If the device is provided with a gripper tool 8 in a container, this tool is also removed. In the next step, a cleaning fluid, such as saline or tap water, is poured over the sample for a predetermined duration (e.g., approximately 5 to 15 seconds) while gently rotating the sputum cleaner (see Figure 14 Step (C) shown). During this period, Figure 1 -8 (wherein the cleaning fluid is discharged from the decanting port and out of the opening at the top of the container). (See Figure 10 As shown in Figures (D) and (E) in Figure 14 In the disclosed method, the cleaning fluid is discharged from an opening at the bottom of the container. In addition, this discharge is performed simultaneously with the cleaning / rinsing (cleansing) of the sputum sample, rather than after agitation. Therefore, Figure 11 and 12 The container 90 in the sputum washer embodiment does not need to have a cleaning fluid fill line.

[0084] Next, the bottom cover 96 is placed back on the device and the sample is taken (see Figure 14 (However, the sample can be taken without replacing the bottom cover 96.) The sample can be sampled (removed) from the mesh for laboratory testing. Figure 10 As shown in step (F) of the method, a grabber tool 8 can be used to facilitate sampling using a grabber tool. If the sputum cleaner includes a sputum cutting feature, this feature can be used to cut (limit or reduce) the sample. Alternatively, sampling of the cleaned sputum sample can be performed from the plate using a loop or a pipette.

[0085] Once the cleaned specimen has been evaluated and / or sampled, it can be refrigerated for future testing. Depending on the duration of storage, the washing procedure may be repeated at a later time. If the specimen is no longer needed, the sputum wash container should be discarded according to a CLIA-approved biohazard disposal protocol.

[0086] Alternatively, in an embodiment of the sputum washer using a top cover and a bottom cover, the cleaning method may include the following steps: (a) removing the top cover; (b) filling the sputum washer with cleaning fluid to the fill line; (c) replacing the top cover; (d) flipping / rolling (i.e., agitating) for a predetermined duration to expose the sputum bolus to the cleaning fluid to dilute and dissolve saliva contaminants from the sample bolus; (e) inverting the sputum washer with the top cover on top; (f) removing the "bottom" cover, which is now at the top of the inverted device, and decanting (draining) the cleaning fluid from the device; (g) with the device in the inverted orientation, replacing the bottom cover (note that this step can be omitted); (h) inverting the device again to place it in the initial orientation (i.e., with the top cover on top again); (i) removing the top cover and using a grabber tool to take a sample from an area of ​​the mesh.

[0087] Although the foregoing description discloses specific values, unless otherwise explicitly stated, other specific values ​​may be used to achieve similar results. In addition, various features of the foregoing embodiments may be selected and combined to produce a variety of variations to improve the system. For example, Figure 1 The sputum cleaner embodiment disclosed in -8 can be used during the sputum sample collection process Figure 12 The suction top cover 101 disclosed in .

[0088] In the foregoing description, exemplary embodiments have been described. However, those skilled in the art will appreciate that various modifications and variations may be made without departing from the scope of the present invention as set forth in the following claims. The description and drawings are therefore to be regarded as illustrative rather than restrictive, and all such modifications are intended to be included within the scope of the present teachings, the scope of the present invention being limited solely by the claims.

[0089] Furthermore, in this document, relative terms such as first and second may be used solely to distinguish one entity or action from another, without necessarily requiring or implying any actual relationship or order between those entities or actions. The terms "comprise," "including," "have," "include," "contain," "includes," "contains," or any other variations thereof are intended to encompass non-exclusive inclusion, such that a process, method, article, or apparatus that comprises, has, contains, or contains a list of elements includes not only those elements but also other elements not expressly listed or inherent to those processes, methods, articles, or apparatuses. An element preceded by "comprises...a," "has...a," "includes...a," or "contains...a" does not, without more limitation, preclude the presence of additional identical elements in the process, method, article, or apparatus that comprises, has, contains, or contains that element. The terms "a" and "an" are defined as one or more, unless expressly stated otherwise herein. The terms "substantially," "substantially," "approximately," "about," or any other forms thereof are defined as approximate to what one of ordinary skill in the art would understand. The term "coupled," as used herein, is defined as connected, although not necessarily directly connected. A device or structure that is "configured" in a certain way is configured in at least that way, but may also be configured in ways that are not listed.

[0090] The Abstract of the present disclosure is provided to allow the reader to quickly ascertain the nature of the technical disclosure. This application is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Furthermore, in the foregoing Detailed Description, various features are grouped together in various embodiments for the purpose of simplifying the disclosure. This method of disclosure should not be interpreted as reflecting an intention that the claimed embodiments require more features than expressly recited in each claim. On the contrary, as reflected in the following claims, the inventive subject matter lies in less than all the features of a single disclosed embodiment. Accordingly, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as separately claimed subject matter.

Claims

1. A sample collection device comprising: a) a container having a top end, a bottom end, a peripheral sidewall, and an opening at the top end; b) a mesh positioned within the container opening and above the bottom end, the mesh being configured to support a sputum sample and also configured to allow a cleaning fluid to pass therethrough; c) a flange supporting the mesh and extending from the mesh to the peripheral sidewall, the flange having a decanting port located between the mesh and the peripheral sidewall; as well as d) a removable cover configured to seal the opening of the container, wherein the removable cover includes a first circumferential rib extending from a lower surface of the removable cover and configured to press the flange when sealing the opening of the container to form a barrier between the mesh and the decanting port, the barrier being capable of blocking the sputum sample from transferring from the mesh to the decanting port along the upper surface of the flange during washing of the sputum sample.

2. The device according to claim 1, wherein The removable cover includes a textured surface for manual gripping.

3. The device according to claim 1, wherein The removable cap is secured to the container via a threaded connection.

4. The device according to claim 1, wherein The lower surface of the removable lid includes a second circumferential rib having a larger diameter than the first circumferential rib, the second circumferential rib being configured to enhance the seal of the container when pressed against the flange.

5. The apparatus according to claim 1, wherein The flange also includes a protrusion above the mesh configured to prevent the sputum sample from being discarded during the discharge of the washing fluid through the decanting port and out of the container opening.

6. The device according to claim 5, wherein The edge of the projection has a profile that facilitates cutting of the sputum sample during sample collection.

7. The apparatus according to claim 6, wherein The profile includes grooves that facilitate cutting of the sputum sample during sample collection.

8. The apparatus of claim 1 further comprising a grabber tool to facilitate sample extraction.

9. The apparatus according to claim 8, wherein The grabber tool is configured to be received in the transfer port.

10. The apparatus according to claim 1, wherein The mesh is conical and includes a sampling ring plate on the bottom.

11. The apparatus according to claim 1, wherein The peripheral sidewall includes a cleaning fluid fill line.

12. A sample collection method comprising the following steps: A device is provided, comprising: i) a container having a top end, a bottom end, a peripheral sidewall, and an opening at the top end; ii) a screen positioned within the opening and above the bottom end, the screen configured to retain a sputum sample and also configured to allow a wash fluid to pass therethrough; iii) a flange supporting the screen, extending from the screen to the peripheral sidewall, the flange having a decanting port located between the screen and the peripheral sidewall; and iv) a removable cover comprising a first circumferential rib extending from a lower surface of the removable cover; depositing the sputum sample on the mesh; sealing the container using the removable cap, wherein the first circumferential rib presses against the flange to form a barrier between the mesh and the decanting port when sealing the opening of the container; agitating the sputum sample in the presence of a cleaning fluid to clean the sputum sample and remove contaminants from the sputum sample, wherein the barrier is capable of blocking the sputum sample from transferring along the upper surface of the flange from the mesh to the decanting port during the cleaning of the sputum sample; opening the container; and The cleaning fluid is drained from the container via the decanting port and discharged out of the container opening.

13. The method of claim 12, further comprising the step of manually removing at least a portion of the sputum sample from the container using a grasper tool.

14. The method of claim 13, further comprising the step of cutting the sputum sample during removal of at least a portion of the sputum sample from the container.

15. The method of claim 13, further comprising the step of removing the gripper tool from a storage position within the container.

16. The method of claim 12, further comprising the step of pouring the cleaning fluid into the container up to a fill line located on the peripheral sidewall of the container.

17. The method of claim 12, further comprising the step of removing the lid from within the container.

18. The method according to claim 12, wherein: The agitating step is performed for a predetermined duration.

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