WO2021206984A1

WO2021206984A1 - Oral sample collection or delivery device and methods

Info

Publication number: WO2021206984A1
Application number: PCT/US2021/025299
Authority: WO
Inventors: Tao Shen; Chengyang PENG
Original assignee: Kent State University
Priority date: 2020-04-09
Filing date: 2021-04-01
Publication date: 2021-10-14

Abstract

The present disclosure provides devices, methods and kits for collecting a sample from the oral cavity of a patient for testing or for delivering a substance to the oral cavity. The collection device may comprise a housing member having a swab support to position a swab tip at a predetermined location in a patient's oral cavity, with the swab support enabling movement of the swab tip into and out of the oral cavity and rotation of the swab tip when engaged with tissue in the oral cavity.

Description

ORAL SAMPLE COLLECTION OR DELIVERY DEVICE AND METHODS

CROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims priority to and the benefit of U. S. Provisional Patent Application No. 63/007,560 filed on April 9, 2020, and is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

[0002] A swab assembly is provided for collecting a specimen from a patient or for delivering biological agents or medications, either themselves or by medical personnel. The swab assembly includes a swab with an elongated swab rod and a specimen collecting end, which is positionable in a swab support assembly. The swab support assembly allows positioning the specimen collecting end of the swab to collect a specimen of cells or deliver a biological agent or other agent in a safe and effective manner.

BACKGROUND

[0003] Early diagnosis of influenza, coronavirus or other respiratory diseases is important to configure a timely treatment and appropriate infection control. The most common sampling strategies for these diseases are nasopharyngeal (NP) and oropharyngeal (OP) swabbing. The swabbing collects specimens used to detect the etiologic agent during a respiratory disease outbreak. When a specific pathogen is known or very strongly suspected, specimen collection may be tailored to the pathogen. To be effective, the specimen must be collected in a suitable manner to submit specimens for reference testing to Center for Disease Control (CDC) or other suitable testing authority for example. In the United States for example, all specimen submissions to CDC require first approval by the individual State Health Department and CDC prior to shipment, making the collection critical to effectiveness. Each respiratory pathogen requires a unique set of specimen types, collection methods and handling conditions to optimize diagnostic yield. Testing may be designed for detection of multiple pathogens, or directed at a specific pathogen. Specimen collection may therefore include the use of oropharyngeal (OP) and nasopharyngeal (NP) swabs, which typically include sterile dacron or rayon swabs with plastic shafts or if available, flocked swabs. The OP swab needs to be inserted into the posterior pharynx and tonsillar areas, with the swab rubbed over both tonsillar pillars and posterior oropharynx. To avoid contamination, touching the tongue, teeth, and gums must be avoided, and then the swab is immediately placed into a sterile vial containing a suitable viral transport media. In many situations, collecting combined NP and OP specimens may be the most effective approach to collection of specimens.

[0004] The NP swabbing is relatively straightforward to operate with the smaller nasal cavity and stmcture. However, the procedure of OP swabbing is relatively complex and challenging with multiple organs and teeth in a larger oral cavity. Existing OP swabbing kits are usually made of one or two small wads of cotton wrapped around one short wood rod. With this kit, existing OP swabbing procedure mainly relies on the professional operation from a medical worker. In addition, when the swab reaches the tonsils or other sensitive organs, the patient might spontaneously react with a gagging reflex which makes the patient close the mouth, leading the swab to touch oral palate or tongue and resulting in a defective sampling. This reflex itself could also cause aerosol emission of fluids from the patient during specimen collection, which in turn could expose a health worker or others to disease. Incidents such as patient gagging could increase medical workers’ infection risk if the patient has contracted a contagious disease.

[0005] It would be desirable to provide a system and method that would allow for the effective and safe collection of OP specimens for testing that avoids the problems of existing systems and methods.

SUMMARY

[0006] This invention comprises a swab assembly for the non-invasive procurement of cells, present in the upper respiratory secretions, including vimses, molecules and macromolecules, for medical diagnosis and scientific studies. The invention further provides an effective system and method of delivering biological agents or medications to the oropharyngeal regions. The swab assembly comprises a housing including a swab holder configured to support a swab or delivery device at a predetermined location with the swab being slidable and rotatable relative to the swab holder, and possibly allowing lateral movement of the swab. The housing may include structures to prevent contact of the swab with the tongue, teeth, and gums. These structures may include a tongue inhibitor, an oral cavity cover, a mouth cover in combination or separately.

[0007] This invention comprises a device and method for the non-invasive procurement of cells, such as exfoliated upper respiratory tract epithelial cells or other cell types, in the upper respiratory secretions, including viruses, molecules and macromolecules, and a method of oropharyngeal administration directly to the mouth and pharynx, for delivering biological agents or medications to the oropharyngeal regions, such as to provide a delivery technique for the needleless delivery of vaccines or other medicaments or agents. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] FIG. 1 is a depiction of the device according to an example of the invention in use with a patient.

[0009] FIG. 2 shows a perspective of the device according to the example of the invention shown in FIG. 1.

[0010] FIG. 3 shows a swab and different lengths of a limit device usable therewith.

[0011] FIG. 4 shows a cross-section view of the device according to the example of the invention shown in FIG. 1.

[0012] FIG. 5 shows an enlarged portion of the cross-section view of FIG. 3 at the location of the aperture in the swab holder or cover member of the device.

[0013] FIG. 6 shows a geometrical model of the swab movement in relation to the aperture in the swab holder.

[0014] FIG. 7 shows an example swab assembly with an arrangement for delivering a biological or other agent.

DESCRIPTION OF THE INVENTION

[0015] The present invention relates to a sample or specimen collection device and/or delivery device and method for the collection of cells or other materials or the delivery of a substance, from or to the oral cavity. The device that allows patients to swab their throat (or tonsils) and collect specimen by themselves for medical testing. Alternatively, the device may be used to facilitate collection of a specimen from children or disabled individuals for example. The invention makes the swabbing procedure convenient and easy to operate by the patient so that it reduces the workload of the medical workers, and especially minimizes the exposure of medical workers in contagious disease environment. According to an example, the device 10 is provided to have a size to accommodate different patients, including adults and children for example. The device 10 may include a housing 12 that is positioned in the patients mouth and oral cavity as shown in FIG. 1. As will be described, the housing 12 may include a region to be held in position by the mouth or gums in relation to the oral cavity of the patient. The housing 12 includes a swab holder 14 configured to support a swab 16 at a predetermined location with the swab 16 being slidable and rotatable relative to the swab holder 14. As seen in FIG. 1, the swab 16 may be of typical configuration, with a shaft terminating in a synthetic tip or other suitable tip. For testing of upper respiratory infections for example, it is suggested that no calcium alginate tips, swabs with preservatives, or swabs with wood shafts be used. The swab 16 has a length to position the tip adjacent the posterior pharynx and tonsillar areas of the patient. The swab holder 14 allows the swab 16 to be inserted into the oral cavity 18 and rubbed over both tonsillar pillars and posterior oropharynx. To avoid contamination, the housing 12 and swab holder 14 prevent touching the tongue 20, upper teeth 22, and lower teeth 24 and gums while the swab 16 is inserted into the oral cavity 18. The swab holder 14 may be configured to be attachable and detachable to the housing 12 to allow for easy insertion and removal of the swab 16 into and from the oral cavity 18. A limit device as will be described may be provided to limit the extent to which the swab can be inserted. After a specimen is collected, the housing 12 can be removed and the limit device removed to allow the swab 16 to be easily and immediately placed into a sterile vial containing a suitable viral transport media after collection of an OP specimen. The term "specimen" or “sample” as used herein, generally refers to a tissue sample, a bodily fluid sample, cells or other biological samples. For example, a sample can be but is not limited to tissues or cells obtainable from the posterior pharynx and tonsillar areas or other body parts of a patient. The device 10 also allows the patient themselves to simply and safely collect an OP specimen for testing. The ability for a patient to self-procure a specimen without risking medical personnel may greatly reduce the risk of contaminating the hospital or clinic environment or nosocomial infection of other patients or staff via contaminated aerosol. The device 10 also reduces patient discomfort by allowing the patient to control the sampling of tissues in the oropharyngeal region. When used as part of a kit for example, the procedure can be performed in the patient's own home or in an isolation or quarantine facility. The device 10 may also allow for testing to be readily repeated, either immediately to give more specimens for other studies, or to detect changes in viral load during disease evolution or in response to therapy for example.

[0016] The device 10 may also be used for the delivery of a substance to the oral cavity 18. According to an example, the swab 16 may be have a substance applied to the tip or delivered at the tip, to then allow the application of the substance to the oral cavity 18 and/or oropharyngeal region. The swab holder 14 may allow freedom of movement of the swab 16 both into and out of the oral cavity, but also pivotal or lateral motion to position the tip at different locations in the oral cavity 18. Such allowed movement may correlate to the desired use of the device to collect a specimen or deliver a substance for example.

[0017] In FIG. 2, the example device 10 is shown with a swab 16 positioned with swab holder 14. The swab holder 14 may be a cover member 30 with an aperture 32 through which a swab rod 34 and tip 36 are inserted to collect a specimen or apply a medicament, vaccine or the like. The swab 16 may be positioned prior to use by a patient, or after the housing 12 is positioned in the mouth as shown in FIG. 1. A limit device 38 may be provided to prevent insertion of rod 34 more than a predetermined amount. The extent to which tip 36 can be inserted is thus limited to prevent injury, with device 38 functioning to limit the displacement of the shaft or rod 34 with respect to cover member 30, for protection from rushing and/or intense push. The limit device 38 may have different lengths as shown in FIG. 3, so that it will be suitable for a wide population based on characteristics of a patient such as age, race, and gender. One end 39 of the limit device 38 may be positioned to match the breaking-off point 35 of the shaft 34 of the swab 16, as shown in Figure 3. This is to facilitate the breaking shaft 34 to drop the specimen in a medical container (e.g. tube) after the sampling. At the other end of the limit device 38, an enlarged clip portion 41 allows the limit device to be positioned and retained at the desired location on the shaft 34, and prevents further movement of the shaft into the oral cavity during use. The cover member 30 may be planar as shown or may be spherical or rounded to project away from the user, allowing visibility of the rod 34 therewith. The aperture or opening 32 allows movement of the rod 34 toward and away from the oropharyngeal regions to be positioned relative to the desired location in the oral cavity, and allows rotation and/or lateral movement to allow engagement with the desired oropharyngeal or other regions in a controlled and efficient manner. The swab holder 14 may allow for predetermined lateral movement relative to cover member 30 by any suitable arrangement, to allow the tip to be moved to engage other portions of the oral cavity if desired.

[0018] With reference to FIGS. 3 and 4, in an example, the aperture 32 may be shaped to allow the desired extent of the oropharyngeal regions to be available to the swab tip 36 during use to collect a specimen. In an example, the desired area the swab tip 36 can reach in the oral cavity may be the area of the posterior pharynx and tonsillar edge. In this example, the aperture 32 may be shaped as a truncated cone which allows sliding and rotating the swab shaft in a controlled and efficient manner, as well as lateral movement over a predetermined extent corresponding to the posterior pharynx and tonsillar edge. In this example, the dimensions of the shaped aperture may be set based on the size of the limit device and the thickness of the cover member of the swab holder. It may be desired to allow the swab tip to reach predetermined extreme positions in the oropharyngeal region for example. As the human oral stmcture varies from person to person in size or other characteristics, it may be desired to configure the aperture 32 to correspond to the desired range of motion for different categories of patients for example. Characteristics such as the patients’ age, weight, gender or the like can be used to tailor the device 10 for use by different patients. As an example, the desired range to collection of a specimen from the oropharyngeal region in an adults’ throat can be set, which may correspond to a large group of patients. Adjusting the parameters of the shaped aperture and/or the limit device may allow the device 10 to be standardized according to patients’ age, weight, gender or other characteristics.

[0019] As shown in Fig. 3 - 5 for example, the distance between Point E and F determines the diameter of the targeted swab site (l_EF). The shaped aperture 32 has a cone top surface diameter (l_AB) and base diameter (l_CD) in terms of the diameter of the limit device (d), the diameter of the targeted swab site (l_EF), the swab effective length (l_QE or l_0F) and the thickness of the tmncated cone (h) as seen in the geometrical model in FIG. 5. The base slope angle Q can be obtained from the geometrical model in FIG. 5 as follows: q = arcsin(2 l_0E/l_EF) (1) [0020] To make the swab rod reach the extreme points, the limited device should be tilted by a certain degree and touch point A and point B at this moment. Thus, l_AB, the diameter of the upper circle of the truncated cone shape aperture, can be obtained with Eq. (2) as follows

7 — ^d ^AB sinO (2)

[0021] Therefore, the base diameter l_CD can be obtained through the isosceles trapezoid shape relationship as follows.

[0022] By arranging (1), (2), and (3), dimensions of the truncated cone shape aperture can be obtained as follows.

(4) ( — )) (5)

IEF

The parameters of the shaped aperture (l_AB, l_CD and h) and/or the limit device ( d and l_d) may allow the device 10 to be standardized according to patients’ age, weight, gender or other characteristics.

[0023] The cover member 30 may be a part of or separately attached to a mouth cover 40 which has a shape to cover the mouth of the patient entirely, with the lips behind the cover 40, but other suitable shapes are contemplated. The cover member 30 may be clear to allow viewing through it. The mouth cover 40 mainly touches the lips to provide both fixture and safety protection functions. Behind the mouth cover 40 may be provided at least one wall cover 42, extending around the opening in mouth cover 40. At the top and bottom portions of wall cover 42 may be provided teeth slots 44, that the patient can engage with their teeth to position the housing 12 in the mouth. The mouthpiece is configured to be gripped between the upper teeth 22 and lower teeth 24 of the user with the user biting thereon, with the lips of the user providing a seal with the wall cover 42, and positioning tip 36 relative to the oropharyngeal regions in a controlled manner while depressing the tongue when the user is biting on the mouthpiece wall cover 42. The wall cover 42 thus serves as a mouthpiece unit which is gripped in the mouth of a user with rod 34 and tip 36 of swab 16 extending into the oral cavity of the user and through which a specimen is collected from the oropharyngeal regions or a substance is delivered to mucosal surfaces of the oral cavity. The wall cover 42 forms an orifice for operation of swab 16. A tongue inhibitor 46 may be provided to extend rearwardly from the wall cover 42, to keep the tongue below it and depressed so that the tongue does not touch the swab 16 or affect the sampling effectiveness.

[0024] The size of the oropharyngeal swab assembly 10 may be standardized according to patients’ age, height and weight or other factors. The wall cover 42, mouth cover 40, tongue inhibitor 46, and cover member 30 may be formed as one unit, which may be made of biocompatible and disposable materials, or may be made of parts assembled together. Some parts may be reusable if desired. The housing 12 may include structures to prevent contact of the swab tip 36 with the tongue, teeth, and gums of the patient. The swab tip 36 is positioned to collect a specimen or apply a substance, while preventing possible exposure to pathogens from the patient. The cover member 30 and mouth cover 40 prevent aerosol emissions from the oral cavity during specimen collection, even in the event the patient experiences a gag reflex during use. [0025] In use, the swab assembly 10 may allow a user to themselves accurately and effectively collect a specimen from their oropharyngeal region for testing or other purpose. Once the swab 16 is inserted into the oral cavity through cover member 30 and swab holder 14, the tip 36, which typically includes sterile dacron or rayon swab materials is inserted into the posterior pharynx and tonsillar areas, with the swab tip 36 rubbed over both tonsillar pillars and posterior oropharynx. To avoid contamination, the position of the tip 36 is controlled by the swab holder, with the tongue, teeth, and gums covered by the device 10. The user can then retract the swab until the tip 36 is positioned near the cover member 30, until the score line typically provided on the rod 36 is positioned at the swab holder 14 where it can be bent to separate the tip 36 from the rod 34 to allow the tip 36 to be immediately placed into a sterile vial containing a suitable viral transport media, without touching the tip 36 to anything else. Alternatively, the swab support 14 may include a mechanism to cut or break the rod 34 to separate the tip 36 therefrom when desired. The assembly 10 facilitates OP specimen collection while minimizing irritation or discomfort, and preventing transmission to others of an infectious disease. The assembly allows for a proper clinical specimen to be collected to avoid compromising the sensitivity and specificity of a laboratory test. The device 10 and methods enable fast, safe, and reliable OP specimen collection for testing. The structure of the swab assembly 10 has features to facilitate standard OP swab sampling and avoid contamination from the oral surface other than the targeted swab site. It also has a feature to create a biting registry to minimize patients’ discomfort in the swab procedures. A shaped aperture or other structure is provided to ensure the motion trajectory of the swab tip is located within the expected range. Limiting the accessible areas of the oral cavity to the swab tip during the swabbing procedure eliminates touching of any oral surface other than the targeted swab or application site. [0026] The swab assembly 10 may also be used for the needleless delivery of vaccines, medicaments, colostrum or other substances as may be desired. For example, vaccines may be used to attempt to provide mucosal immunity, particularly by inducing the local production of antibodies which may block epithelial colonization and penetration of pathogens into the body.

In an example, the rod 34 may include a reservoir 50 for a substance and an arrangement to cause delivery of the substance to the tip 36 when tip 36 is positioned in the oral cavity, such as a plunger 52 or other suitable arrangement as seen in FIG. 6. For example, Oropharyngeally- administered mother's colostrum and milk can be utilized as an adjunct immunological intervention to protect infants against infections. During oropharyngeal administration, milk is placed directly onto the oral mucosa, followed by gentle buccal swabbing to evenly distribute the milk. Other substances may be delivered as desired.

[0027] In an example, the swab assembly 10 may be provided as part of a kit for OP specimen collection and/or testing. The kit may comprise: a collection device comprising (i) a swab assembly 10, and vessel that includes viral transport media or reagents necessary for testing of cells collected from the oropharyngeal tissues, wherein the collection vessel is adapted to accept at least one swab. The kit may also include instructions that permit a user to (a) collect a biological sample from the oropharyngeal tissues using the at least one swab, and (b) deposit the at least one swab having the biological sample into the collection. Such a kit could also be used by a health professional to collect a specimen from a patient.

[0028] Additional aspects and advantages of the present disclosure will become readily apparent to those skilled in this art from the following detailed description, wherein only illustrative embodiments of the present disclosure are shown and described. As will be realized, the present disclosure is capable of other and different embodiments, and its several details are capable of modifications in various obvious respects, all without departing from the disclosure. Accordingly, the drawings and description are to be regarded as illustrative in nature, and not as restrictive.

Claims

What is claimed is:

1. A device for collecting a sample or delivering an agent, comprising: a housing member having a swab support to position a swab tip at a predetermined location in a patient’s oral cavity, with the swab support enabling movement of the swab tip into and out of the oral cavity and rotation of the swab tip.

2. The device of claim 1, where the swab support is provided in a cover member associated with a housing defining an opening through which the swab is moved.

3. The device of claim 2, wherein the housing includes a mouth cover and at least one wall cover extending rearwardly of the mouth cover.

4. The device of claim 3, wherein the wall cover defines an opening and the swab support positions the swab at approximately the center of the opening.

5. The device of claim 3, wherein the wall cover is configured to be gripped between the teeth.

6. The device of claim 3, wherein the wall cover has side portions extending to cover a portion of the user’s teeth, gums and cheeks.

7. The device of claim 2, wherein the housing includes a tongue inhibitor to depress the tongue when positioned in the user’s oral cavity.

8. The device of claim 3, wherein the mouth cover is shaped to substantially cover the lips when the housing is positioned in the mouth.

9. The device of claim 1, further comprising a limit device to prevent insertion of the rod associated with the swab more than a predetermined amount.

10. The device of claim 2, wherein the cover member has an outwardly curved shape and covers the opening in the wall cover, and includes an aperture at approximately the center of the opening through which the swab is insertable and supported with the cover member.

12. The device of claim 10, wherein the aperture is shaped to allow predetermined lateral movement of the swab.

13. The device of claim 12, where in the aperture is shaped as a truncated cone.

14. The device of claim 1, wherein the swab includes a reservoir and arrangement to cause delivery of a substance in the reservoir to the tip of the swab.

15. A method for collecting a biological sample from a subject, comprising: (a) providing a collection device comprising a housing member having a swab support to position a swab tip at a predetermined location in a patient’s oral cavity, (b) positioning a swab with a swab rod supported by the swab support and a tip extending into the patient’s oral cavity; (b) moving the swab tip into engagement with the posterior pharynx and tonsillar areas and rotation of the swab tip when engaged with tissue in the oral cavity, and (c) depositing the swab having the biological sample from the patient in a collection container without touching the swab tip with any other surfaces.

16. A kit to be used for the method described in claim 11, comprising: at least one swab having a rod of predetermined length and a swab tip for collection of a biological sample or administering an agent, at least one swab positioning member including a housing member having a swab support to position a swab tip at a predetermined location in a patient’s oral cavity, and a swab collection container with a seal for collection of the specimen on the swab tip after collection.

17. The kit of claim 16, the swab support is provided in a cover member associated with a housing defining an opening through which the swab is moved, the housing including a mouth cover and at least one wall cover extending rearwardly of the mouth cover.

18. The kit of claim 17, wherein the at least one wall cover has side portions extending to cover a portion of the user’s teeth, gums and cheeks.

19. The kit of claim 17, wherein the housing includes a tongue inhibitor to depress the tongue when positioned in the user’s oral cavity.

20. The kit of claim 17, further including a limit device associated with the rod to prevent insertion of the rod into a user’s oral cavity more than a predetermined amount.