TWI766603B - Facial mask for collecting virus specimen from respirator tracts of human and animals - Google Patents

Abstract

Disclosed herein is related to a facial mask for specimen collection from respiratory tracts of humans and animals, comprising: a body and at least one strip connecting to the body. The body comprises: an inner layer; a sample collecting layer adjacent to the inner layer; a middle layer adjacent to the sample collecting layer; and an outer layer adjacent to the middle layer. The inner layer comprises hydrophobic material, the middle layer comprises melt-blowing non-woven with charge, the outer layer comprises hydrophilic material, and the sample collecting layer is made of melt-blowing non-woven dispersed with ribonuclease inhibitor.

Description

Masks for collecting human and animal respiratory virus samples

The present disclosure relates to a mask for collecting human and animal respiratory virus samples; specifically, the mask is provided with a sample collection layer coated with a nuclease inhibitor.

Infectious diseases continue to pose a major threat to human society, usually the seasonal influenza virus that spreads every year, or the new coronavirus (Covid-19), which usually causes considerable damage to human life and property and society. On the other hand, most infectious diseases with the potential to cause a pandemic can be transmitted to the external environment or other groups through droplets expelled from the respiratory tract. Therefore, in disease prevention, the prevention of airborne droplets to avoid transmission through the respiratory tract is the first priority.

According to research reports, wearing a face shield or mask can effectively prevent ambient airborne droplets from contacting another person through the mouth and respiratory tract, especially medical masks are more effective. Therefore, wearing masks can effectively reduce the spread of human and animal infectious microorganisms, and is also the main equipment for national epidemic prevention.

In addition, when collecting possible samples to diagnose a respiratory infection, physicians often have to insert a sample collection stick with a cotton swab along the subject's nasal and pharyngeal or oropharynx, often causing great discomfort to the subject or animal . Cotton swabs often cause nasal irritation in the individual receiving the sample and make the collection process unbearable and short-lived. The methods of sample collection currently used also severely reduce the willingness of subjects to have to sample regularly as needed. In addition, abnormal stimuli to subjects during sample collection can also cause sneezing and coughing, further triggering feelings of nausea, vomiting, or a dry cough. These reflex responses often result in abnormal mouth foam discharge from the subject's body, increasing the risk of inhalation and infection by the medical staff performing the sample collection. Furthermore, the viability of the collected microorganisms may decrease in a short period of time and may be degraded over time, resulting in insufficient effective virus samples, increasing the chance of false negatives in the test, and making subsequent diagnosis difficult. In view of the above, there is an urgent need in the art to develop a sample collection device that can collect potentially infectious microorganisms from the respiratory tract, while reducing the discomfort of the subject being diagnosed.

In order to solve the above problems and achieve the purpose of the invention, the present disclosure provides a mask for collecting human and animal respiratory virus samples, comprising: a main body and at least one strap connecting the main body. The body includes: an inner layer; a sample collection layer adjacent to the inner layer; a middle layer adjacent to the sample collection layer; and an outer layer adjacent to the middle layer. The inner layer is a hydrophilic material, the middle layer is a melt-blown non-woven fabric with electric charges, and the outer layer is a hydrophobic material.

In one embodiment, the sample collection layer is a meltblown nonwoven fabric coated with a nuclease inhibitor

In one embodiment, the sample collection layer is used to collect viruses, bacteria, or fungi.

In one embodiment, the nuclease inhibitor is an RNase inhibitor or a DNase inhibitor.

In one embodiment, the meltblown nonwoven fabric is produced by a plurality of meltblown fibers or a plurality of meltblown fibers through a hot pressing process.

In one embodiment, the body has a width W, and the length of the sample collection layer along the width W direction is about 4 cm.

In one embodiment, the body further includes a flexible member adjacent to an edge in the longitudinal direction; wherein the sample collection layer has a first edge and a second edge opposite thereto, and the first edge is adjacent to the flexible member. One side of the flexible member, and the second edge is away from the other side of the flexible member, from the second edge to the side of the body adjacent to the flexible member 20 has a second width W', the second width W' About 1/2W.

In one embodiment, the second width W' is about 8.5 cm.

In one embodiment, the body has a plurality of folds, and through the folds, the body is folded to form a plurality of inner folds.

The technical features of the present disclosure, including specific features, are disclosed in the scope of the patent application. With regard to the technical features of the present disclosure, it is better understood that the present disclosure will be described in detail as follows in conjunction with the description, embodiments based on the principles of the present disclosure, and drawings.

Unless otherwise defined, all technical and scientific terms described in this disclosure and the scope of the patent application have the definitions known to those of ordinary skill in the technical field to which this disclosure belongs. The singular terms "a", "an", "the", or similar terms, unless otherwise stated, may refer to more than one object. "Or", "and" and "and" used in this manual refer to "or/and" unless otherwise specified. In addition, the terms "includes" and "includes" are not open-ended conjunctions of limitation. The foregoing definitions are merely indicative of the definitions of terms and should not be construed as limitations on the subject matter. Unless otherwise stated, materials used in this disclosure are commercially available and readily available.

The ordinal numbers mentioned in this specification and claims, such as "first", "second", etc., are only used to describe the disclosed elements, and do not refer to or indicate that there is any execution order among the elements, nor do they refer to or indicate The sequence between one element and another, or the sequence of steps in a process. These ordinal numbers are only used to clearly distinguish an element with a certain designation from another element with the same designation.

This disclosure relates to a mask for collecting human and animal respiratory virus samples. With the sample collection layer arranged in the middle layer and the inner layer of the mask, the microorganisms released from the mouth and nose of the wearer can be effectively adsorbed and blocked in the sample collection layer, and the sample collection layer can be further taken out for laboratory use. detection. In the present disclosure, the microorganisms include, but are not limited to, viruses, bacteria, or fungi.

FIG. 1 is a mask 100 for collecting human and animal respiratory virus samples according to the present disclosure, including: a main body 10 , a flexible member 20 , and at least one strap 30 for fixing the mask to the face. The body 10 has a length L and a width W, and the flexible member 20 is adjacent to an edge in the length direction.

FIG. 2 is a partial cross-sectional view of the mask 100 of FIG. 1 . The mask 100 of the present disclosure is provided with an inner layer 111 , a sample collection layer 112 , a middle layer 113 , and an outer layer 114 from the inside to the outside. The inner layer 111 can be a hydrophilic material, such as a hydrophilic non-woven fabric, which can effectively absorb moisture. The middle layer 113 is a filter layer, which is a melt-blown non-woven fabric with electric charge, used to block microorganisms. The outer layer 114 is a waterproof layer, which can be a hydrophobic material, such as a hydrophobic non-woven fabric, for preventing the penetration of water and liquid.

More specifically, the middle layer 113 is made of meltblowing technology. Meltblown technology extrudes molten polymer through a nozzle surrounded by high-speed blowing gas, thereby randomly depositing non-woven sheet products, which are suitable for filtering and adsorbing air particles.

In the present disclosure, the melt-blown non-woven fabric can be produced by the following method: the non-woven fabric material is melted at high temperature, and after the melt is ejected from the spinning nozzle in a fibrous form, the fibrous melt is drawn by a high-temperature and high-speed gas. to obtain a plurality of meltblown fibers on the collecting device.

In the present disclosure, a meltblown nonwoven fabric can be obtained by directly collecting a plurality of meltblown fibers. However, the present disclosure is not limited thereto, and in other embodiments, the collected meltblown fibers can be subjected to a hot pressing process to obtain a meltblown fiber nonwoven film.

The sample collection layer 112 is made of meltblown non-woven fabric, and the difference from the middle layer 113 is that the sample collection layer 112 is coated with a nuclease inhibitor. Specifically, Ribonuclease inhibitors are large molecular weight (~49 kDa), acidic (pI ~4.7), leucine-rich repeat proteins that can form tight bonds with specific nucleases complex. In the present disclosure, the nuclease inhibitor should use a nuclease inhibitor with biocompatibility and low toxicity. More specifically, the nuclease inhibitor can be an RNase (RNase) inhibitor or a DNAse (DNase) inhibitor, which can be replaced according to actual needs.

The sample collection layer 112 has a collection area 1121 located at the center in the length direction of the sample collection layer. The collection area is the main area for collecting microbial particles, and it is also the area where most of the microorganisms released from the nose and mouth droplets adhere to the collection layer. Accordingly, the collection area 1121 can be configured to be separated or torn from the sample collection layer 112 .

By providing the sample collection layer 112 containing the nuclease inhibitor, the mask 100 of the present disclosure can prolong the period during which microorganisms are attached to the mask, which is helpful for diagnosing whether the wearer has or is infected with related pathogens or diseases. For example, if a patient is suspected to be infected with the coronavirus disease, the patient can be made to wear the mask 100 disclosed in this disclosure, and the collection area 1121 of the sample collection layer 112 can be removed within a certain period of time, and further tested in the laboratory for infection with specific microorganisms . The mask 100 disclosed in the present disclosure is helpful for diagnosing whether a patient is infected with a specific microorganism, so that the time for collecting samples is not limited to the period during which the medical testing personnel collect the samples, and it is easier to collect for a longer time, which is beneficial to quarantine and epidemic prevention measures.

In addition, the straps 30 are preferably two sets of straps, which can be ear-hook or strap-type straps, or other straps that can be used to fix the position of the mask. One end of the strap 30 is fixed to the upper end of the main body 10 , and the other end is fixed to the lower end of the main body 10 .

The body 10 has a length L and a width W. In a preferred embodiment, the width W is between 15-20 centimeters (cm). In a more preferred embodiment, the width W is about 17.5 cm.

In addition, the length of the sample collection layer 112 along the width W direction is about 4 cm. The length of the collection area 1121 along the length L direction is about 6 cm.

In another embodiment, the body 10 has a plurality of folds 101 , and through the folds, the body 10 can be folded to form a plurality of inner folds.

In another embodiment, the sample collection layer 112 has a first edge and a second edge opposite thereto, wherein the first edge is adjacent to an edge of the flexible member 20 and the second edge is away from the flexible member 20 . the other side of the member 20. From the second edge to a side of the body 10 adjacent to the flexible member 20, there is a second width W', and the second width W' is about 1/2W. Or in another embodiment, the second width W' is about 8.5 cm.

In order to test the sample collection efficiency of the mask 100 disclosed in the present disclosure, the following experiments were conducted. The virus used in this disclosure is coronavirus (Coronavirus OC43), but the masks in this disclosure are not limited to collecting viruses, but can also be applied to other infectious microorganisms.

First, the aseptically treated sample collection layer 112 is obtained, coated with nuclease inhibitor, divided into 5 experimental groups, and then placed in a culture plate. 10 microliters (μl) virus samples (TCID ₅₀ : 10 ² , 10 ¹ , and 10 ⁰ /ml) of different virus amounts were taken, dropped on the aforementioned sample collection layer 112, and placed at room temperature.

The sample collection layer 112 was taken out at 0, 24, 48, and 72 hours, respectively, and was immediately immersed in a viral transport medium (VTM) to effectively release and separate out viral particles.

Then, after separating the virus by centrifugation, viral RNA was extracted to perform quantitative PCR (qPCR). The amount of virus obtained at each time point is disclosed in Table 1.

Table 1 time (hours) viral load RNase inhibitor Ct 0 100 Have 22.82 0 10 Have 27.90 0 1 Have 31.46 twenty four 100 Have 31.46 twenty four 10 Have 30.83 twenty four 1 Have 32.86 48 100 Have 37.09 48 10 Have 34.69 48 1 Have 36.22 72 100 Have N/a 72 10 Have N/a 72 1 Have N/a Positive control group 20.19 negative control group N/a

According to Table 1, 24 hours after the virus was instilled, if the initial virus amount of the sample collection layer 112 was 100, 10, and 1 TCID ₅₀ /ml, respectively, the detectable qPCR critical cycles (Ct) were 31.46, 30.83, and 32.86. At 48 hours after virus instillation, if the initial virus amount of the sample collection layer 112 was 100, 10, and 1 TCID ₅₀ /ml, respectively, the detectable qPCR critical cycles (Ct) were 37.09, 34.69, and 36.22, respectively. After 72 hours after the virus was instilled, no virus amount could be detected.

Therefore, according to Table 1, since the mask 100 of the present disclosure is provided with the sample collection layer 112, virus particles can be retained on the sample collection layer 112 for up to 48 hours, which can overcome the shortcoming that ordinary viruses cannot be stored for a long time at room temperature , to avoid the rapid decomposition of the virus on the mask and the inability to detect its nucleic acid. This disclosure will facilitate diagnosis and quarantine.

Furthermore, after the mask 100 of the present disclosure is provided with the sample collection layer 112, the filtration efficiency and pressure loss are not significantly reduced, and the standard of a general mask can still be maintained.

The filtration efficiency and pressure loss of the mask 100 of the present disclosure are disclosed in Table 2.

Table 2 Filtration efficiency (%) Pressure loss (mmH ₂ O) adult mask 1 96.24 4.4 adult mask 2 96.91 4.6 adult mask 3 97.21 3.1 Children's masks 1 94.62 3.8 Children's masks 2 92.08 3.1 Children's masks 3 94.52 2.9

In general, surgical masks that meet international standards have a filtration effect of more than 90% and a pressure loss of less than 8.0 to qualify as masks that can be used for medical purposes. According to Table 2, whether it is made into an adult mask or a children's mask, the filtration efficiency of the mask 10 of the present disclosure is greater than 90%, and the pressure loss is lower than 4.5. It can be seen that the mask 100 of the present disclosure is provided with a sample collection layer. 112, but it does not affect its filtration efficiency function and pressure loss difference, and it can still effectively filter microorganisms and maintain its pressure loss value.

To sum up, the mask used for sample collection of the present disclosure has several advantages, including: on the one hand, it can be used as a general medical mask, can isolate external microorganisms, and at the same time avoid the release of droplets emitted by the wearer from the upper respiratory tract; On the other hand, due to the provision of the sample collection layer, which is coated with nuclease inhibitors, the droplets released by the wearer can stay on it for a longer period of time. The face is removed after a period of time for further detection and diagnosis. After testing, the mask of the present disclosure can adsorb microorganisms (especially viruses) for up to 48 hours, and the virus can still be detected in the sample collection layer after 48 hours. Therefore, the masks used for collecting human and animal respiratory virus samples in this disclosure not only help reduce the possibility of infection, but also help in quarantine, making the diagnosis of infectious diseases easier.

Based on the contents disclosed in the embodiments of this specification, those skilled in the art to which the present disclosure pertains can clearly understand that the foregoing embodiments are merely illustrative rather than limiting; each embodiment in this specification can be implemented independently or combined with each other; Those skilled in the art can implement through many transformations and substitutions, which are not different from the technical features of the present disclosure. According to the embodiments of the specification, the present disclosure can be modified in various ways without hindering the implementation. The claims provided in this specification define the scope of the disclosure, which includes the foregoing methods and structures and inventions equivalent thereto.

100 Masks for collecting human and animal respiratory virus samples 10 Ontology 101 Creases 20 Flexible member 30 strips 111 inner layer 112 Sample collection layer 1121 Collection area 113 Middle Floor 114 outer layer L length W width W’ Second width

1 is a schematic diagram of the structure of the mask used for collecting human and animal respiratory virus samples according to the present disclosure FIG. 2 is a partial cross-sectional view of the mask of FIG. 1 .

100 Masks for collecting human and animal respiratory virus samples 10 Ontology 101 Creases 20 Flexible member 30 strips 112 Sample collection layer 1121 Collection Area L length W width W’ second width

Claims (8)

A mask for collecting human and animal respiratory virus samples, comprising: a body, including: an inner layer; a sample collection layer adjacent to the inner layer; a middle layer adjacent to the sample collection layer; and an outer layer , adjacent to the middle layer; and at least one band, connecting the body; wherein the inner layer is a hydrophilic material, the sample collection layer is a meltblown non-woven fabric coated with nuclease inhibitors, and the middle layer is a meltblown nonwoven fabric with electric charges, The outer layer is a hydrophobic material. The mask of claim 1, wherein the sample collection layer is used to collect viruses, bacteria, or fungi. The mask of claim 1, wherein the nuclease inhibitor is an RNase inhibitor or a DNase inhibitor. The mask of claim 1, wherein the meltblown non-woven fabric is made of a plurality of meltblown fibers or a plurality of meltblown fibers through a hot pressing process. The mask of claim 1, wherein the body has a width, and the length of the sample collection layer along the width direction is about 4 cm. The mask of claim 5, wherein the body further comprises a flexible member adjacent to an edge in the length direction; wherein the sample collection layer has a first edge and a second edge opposite thereto, and the first edge is Adjacent to one edge of the flexible member, and the second edge is remote from the other edge of the flexible member, from the second edge The edge has a second width from one side of the body adjacent to the flexible member, and the second width is about 1/2 of the width. The mask of claim 6, wherein the second width is about 8.5cm. The mask of claim 1, wherein the main body has a plurality of folds, and through the folds, the main body is folded to form a plurality of inner pleats.

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