TW202214326A - Facial mask for collecting virus specimen from respirator tracts of human and animals - Google Patents
Facial mask for collecting virus specimen from respirator tracts of human and animals Download PDFInfo
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- A—HUMAN NECESSITIES
- A41—WEARING APPAREL
- A41D—OUTERWEAR; PROTECTIVE GARMENTS; ACCESSORIES
- A41D13/00—Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches
- A41D13/05—Professional, industrial or sporting protective garments, e.g. surgeons' gowns or garments protecting against blows or punches protecting only a particular body part
- A41D13/11—Protective face masks, e.g. for surgical use, or for use in foul atmospheres
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- A—HUMAN NECESSITIES
- A62—LIFE-SAVING; FIRE-FIGHTING
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Abstract
Description
本揭露係關於一種用於收集人體與動物呼吸道病毒樣本之口罩;具體而言,該口罩設有塗佈核酸酶抑制劑之一樣本收集層。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.
傳染性疾病持續地對人類社會造成重大威脅,通常是每年傳播的季節性流感病毒、或者是新型冠狀病毒(Covid-19),通常會造成相當大的人類生命與財產及社會損害。另一方面,大多數可能引發大流行的傳染病可通過呼吸道所排出的飛沫傳播到外界環境或其他族群。因此,在疾病預防中,防止經由空氣傳播的飛沫以避免通過呼吸道傳播係,首要之務。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.
據研究報導指出,配戴面罩或口罩可以有效地防止環境空氣傳播的飛沫通過口腔和呼吸道與另一人接觸,尤其醫用口罩更有顯著功效。因此,配戴口罩可有效減少人類與動物傳染性微生物的擴散,亦為全民防疫之主要配備。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.
此外,收集可能的樣本以診斷呼吸道感染時,醫生通常必須沿受測對象的鼻腔和咽腔或口咽腔伸入帶有棉籤的樣本收集棒,經常會引起受測者或動物的極大不適感。棉籤通常會造成接受樣品採集的個人的鼻腔刺激,並使採集過程變得難耐且只能短暫進行採樣。目前所用樣品收集的方法還嚴重降低了受測者根據需要而須定時進行採樣的意願。此外,樣品採集過程中對受測者的異常刺激也會引起噴嚏和咳嗽,進一步觸發噁心感、嘔吐、或乾咳。這些反射性反應常造成受測者體內部位異常的口沫排放,提高執行收集樣本的醫護人員吸入和被傳染之風險。再者,所收集的微生物生存力可能在短時間內降低並可能因時而降解,造成有效病毒樣本不足,增加檢驗假陰性的機會,造成後續診斷困難。鑑於上述情況,本領域亟需開發可自呼吸道收集可能具感染性微生物的樣本收集器材,同時減輕接受診斷的受試者的不適。In addition, when collecting possible samples to diagnose respiratory infections, physicians often have to insert a sample collection stick with cotton swabs along the subject's nasal and pharyngeal or oropharyngeal cavities, 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 discomfort to the subject being diagnosed.
為解決上述之問題並達成發明之目的,本揭露係提供一種用於收集人體與動物呼吸道病毒樣本之口罩,包括:一本體,以及連接該本體之至少一條帶。該本體包括:一內層;一樣本收集層,與該內層相鄰;一中層,與該樣本收集層相鄰;以及一外層,與該中層相鄰。該內層係親水材料,該中層係具有電荷之熔噴不織布,該外層係疏水材料。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.
於一實施例,該樣本收集層係塗佈核酸酶抑制劑之熔噴不織布In one embodiment, the sample collection layer is a meltblown nonwoven fabric coated with a nuclease inhibitor
於一實施例,該樣本收集層係用於收集病毒、細菌、或真菌。In one embodiment, the sample collection layer is used to collect viruses, bacteria, or fungi.
於一實施例,該核酸酶抑制劑係RNA酶抑制劑或DNA酶抑制劑。In one embodiment, the nuclease inhibitor is an RNase inhibitor or a DNase inhibitor.
於一實施例,熔噴不織布係多條熔噴纖維或多條熔噴纖維經熱壓製程而製成。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.
於一實施例,該本體一寬度W,該樣本收集層沿寬度W方向之長度約為4 cm。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.
於一實施例,該本體另包括一可撓構件,相鄰於長度方向之一邊緣;其中該樣本收集層具有一第一邊緣及與其相對之一第二邊緣,該第一邊緣係鄰近該可撓構件之一邊,而該第二邊緣係遠離該可撓構件之另一邊,自第二邊緣起至該本體鄰近該可撓構件20之一邊具有一第二寬度W’,該第二寬度W’約為1/2W。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
於一實施例,該第二寬度W’約為8.5 cm。In one embodiment, the second width W' is about 8.5 cm.
於一實施例,該本體具有複數個摺痕,藉由該些摺痕,該本體折疊構成複數個內褶。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.
本揭露之技術特徵,包含特定特徵,係揭示於申請專利範圍,針對本揭露之技術特徵,較佳之理解茲配合說明書、依據本揭露原理之實施例、和圖式將本揭露詳細說明如下。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 is described in detail as follows in conjunction with the description, embodiments based on the principles of the present disclosure, and drawings.
本揭露說明書及申請專利範圍中所述之所有技術性及科學用語,除非另有所定義,皆為本揭露所屬技術領域具有通常知識者可知曉之定義。其中單數用語「一」、「一個」、「該」、或其近似用語,除非另有說明,皆可指涉多於一個對象。本說明書使用之「或」、「以及」、「和」,除非另有說明,皆指涉「或/和」。此外,用語「包含」、「包括」皆非有所限制之開放式連接詞。前述定義僅說明用語定義之指涉而不應解釋為對標的之限制。除非另有說明,本揭露所用之材料皆為市售易於取得。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.
本說明書和請求項所提及的序數,例如「第一」、「第二」等,僅用於說明所揭露之元件,而非指稱或表示元件之間具有任何執行次序,亦非指稱或表示於一元件和另一元件之間的次序、或製程之步驟次序。該些序數僅用於使具有某命名的一元件得以和另一具有相同命名的元件能清楚區分。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.
本揭露係關於一種用於收集人體與動物呼吸道病毒樣本之口罩。藉由設置於口罩中層以及內層中之樣本收集層,自配戴者的口鼻所釋放的微生物可有效地被吸附以及阻隔於該樣本收集層,進一步可取出樣本收集層,用於實驗室檢測。於本揭露,該微生物包括但不限於病毒、細菌、或真菌。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.
圖1係本揭露之用於收集人體與動物呼吸道病毒樣本之口罩100,包括:一本體10、一可撓構件20、以及用於將口罩固定於臉部之至少一條帶30。該本體10具有一長度L以及一寬度W,該可撓構件20係相鄰於長度方向之一邊緣。FIG. 1 is a
圖2係圖1之口罩100之部分剖面圖。本揭露之口罩100由內而外設有內層111、樣本收集層112、中層113、和外層114。內層111可為親水材料,例如親水性不織布,可有效吸收水氣。中層113為過濾層,係具有電荷之熔噴不織布,用於阻絕微生物。外層114為防水層,可為疏水材料,例如疏水性不織布,用於防止水份、液體滲入。FIG. 2 is a partial cross-sectional view of the
更特定而言,該中層113係由熔噴技術(Meltblowing)所製成。熔噴技術係將熔融之聚合物通過被高速吹塑氣體包圍之噴嘴擠出,從而隨機沉積之非織造片材產品,可適用於過濾及吸附空氣微粒。More specifically, the
於本揭露,可藉由如下方式來製造熔噴不織布:使不織布材料高溫熔融,並使熔融物從紡絲噴嘴呈纖維狀噴出後,藉由高溫高速的氣體來牽引所噴出呈纖維狀之熔融物,以於收集裝置上獲得多條熔噴纖維。In the present disclosure, the melt-blown non-woven fabric can be manufactured 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.
於本揭露,直接收集多條熔噴纖維即可得到熔噴不織布。然而,本揭露不限於此,於其他實施方式,收集到的多條熔噴纖維可再經過熱壓製程,從而得到熔噴纖維不織布膜。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 may be subjected to a hot pressing process to obtain a meltblown fiber nonwoven film.
該樣本收集層112係熔噴不織布所構成,與中層113之差異在於,該樣本收集層112塗佈核酸酶抑制劑。具體而言,核酸酶抑制劑(Ribonuclease inhibitor)係大分子量(~49 kDa)且為酸性(pI ~4.7)、富白胺酸重複(leucine-rich repeat)之蛋白質,可與特定核酸酶形成緊密複合體(complex)。於本揭露,核酸酶抑制劑應使用具有生物相容性、低毒性之核酸酶抑制劑。更具體而言,該核酸酶抑制劑可為RNA酶(RNase)抑制劑或DNA酶(DNase)抑制劑,可依實際需求替換。The
該樣本收集層112具有一收集區1121,位於該樣本收集層長度方向之中央。該收集區係收集微生物顆粒之主要區域,亦為大多自口鼻飛沫釋放之微生物附著於收集層之區域。據此,該收集區1121可組態為:可自該樣本收集層112分離或撕取。The
藉由設置包含核酸酶抑制劑之樣本收集層112,本揭露之口罩100可延長微生物附著於口罩上之期間,有利於診斷配戴受測者是否帶有或感染相關病原體或疾病。例如,若有患者疑似感染冠狀病毒疾病,則可令該患者配戴本揭露之口罩100,於一定期間內取下該樣本收集層112之收集區1121,並於實驗室進一步檢測是否感染特定微生物。本揭露之口罩100有助於診斷患者是否感染特定微生物,讓收集樣本的時間不限於醫療檢測人員收集樣本的期間,且較容易更長時間收集,有利於檢疫及防疫措施。By providing the
此外,該條帶30較佳地係二組條帶,可為耳掛式或綁帶式條帶,或其他可用於固定口罩位置之條帶。該條帶30之一端固定於本體10之上側端,另一端則固定於本體10之下側端。In addition, the
該本體10具有一長度L以及一寬度W。於一較佳實施例,該寬度W係介於15-20公分(cm)。於一更佳實施例,該寬度W係約17.5 cm。The
此外,該樣本收集層112沿寬度W方向之長度約為4 cm。該收集區1121沿長度L方向之長度約6 cm。In addition, the length of the
於另一實施例,該本體10具有複數個摺痕101,藉由該些摺痕,該本體10可折疊構成複數個內褶。In another embodiment, the
於另一實施例,該樣本收集層112具有一第一邊緣及與其相對之一第二邊緣,其中該第一邊緣係鄰近該可撓構件20之一邊,而該第二邊緣係遠離該可撓構件20之另一邊。自第二邊緣起至本體10鄰近該可撓構件20之一邊具有一第二寬度W’,該第二寬度W’約為1/2W。或於另一實施例,該第二寬度W’約為8.5 cm。In another embodiment, the
為測試本揭露之口罩100採集樣本效率,遂進行以下實驗。本揭露所使用之病毒係冠狀病毒(Coronavirus OC43),但本揭露之口罩不限於收集病毒,亦可應用於其他傳染性微生物。In order to test the sample collection efficiency of the
首先取得經無菌處理之樣本收集層112,並塗佈核酸酶抑制劑,分為5個實驗組別後,再放置於培養盤。取不同病毒量之10微升(μl)病毒樣本(TCID
50: 10
2、10
1、和10
0/ml),滴於前述樣本收集層112,並放置於室溫。
First, the aseptically treated
於0、24、48、和72小時分別取出樣本收集層112,立即浸泡於病毒輸送介質(viral transport medium,VTM)中,以 有效釋放及析出病毒顆粒。The
而後,以離心分離病毒後,再萃取病毒RNA,以進行定量PCR(qPCR)。各時間點取得之病毒量揭露於表1。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.
表1
依據表1,於滴入病毒後24小時,若樣本收集層112之初始病毒量分別為100、10、1 TCID
50/ml,則可偵測之qPCR臨界循環(Ct)分別為31.46、30.83、及32.86。於滴入病毒後48小時,若樣本收集層112之初始病毒量分別為100、10、1 TCID
50/ml,則可偵測之qPCR臨界循環(Ct)分別為37.09、34.69、及36.22。於滴入病毒後72小時之後,便無法偵測任何病毒量。
According to Table 1, 24 hours after the virus was instilled, if the initial virus amount of the
因此,依據表1可得知,本揭露之口罩100由於設置樣本收集層112,於樣本收集層112上可保留病毒顆粒長達48小時,可克服一般病毒無法於室溫下長時間保存之缺點,避免病毒於口罩上快速分解而無法偵測其核酸,此揭露將有利於診斷以及檢疫。Therefore, according to Table 1, since the
再者,本揭露之口罩100設置樣本收集層112後,其濾效及壓損並無顯著降低,仍可維持一般口罩之標準。Furthermore, after the
本揭露之口罩100之濾效及壓損揭露於表2。The filtration efficiency and pressure loss of the
表2
一般合乎國際標準之外科口罩,其濾效應高於90%,而壓損應低於8.0,方為合格、可用於醫療用途之口罩。依據表2,無論是製成成人口罩或兒童口罩,本揭露之口罩10之濾效均大於90%,以及壓損均低於4.5,由此可知本揭露之口罩100雖另設置一樣本收集層112,但不影響其濾效功能及壓損差,仍可有效過濾微生物以及維持其壓損值。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
綜上所述,本揭露之用於收集樣本之口罩具有多項優勢,包括:一方面具有一般醫用口罩之用途,可隔絕外來之微生物,同時避免配戴者自上呼吸道所噴發的飛沫釋放;另一方面,由於設置樣本收集層,其中塗佈核酸酶抑制劑,可使配戴者所釋放的飛沫停留於其上達更持久時間,除了延長微生物存活停留期間,可配戴於疑似感染者的臉部,待一段時間後取下,進一步用於檢測及診斷。經測試,本揭露之口罩可吸附微生物(特別是病毒)長達48小時,於48小時後仍可於樣本收集層偵測到病毒。因此,本揭露之用於收集人體與動物呼吸道病毒樣本之口罩除了有助於降低傳染之可能性之外,對於檢疫亦可帶來助益,使傳染性疾病之診斷更加簡便。To sum up, the mask used for sample collection of the present disclosure has several advantages, including: on the one hand, it has the function of a general medical mask, which can isolate foreign 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.
於本說明書實施例揭示之內容,本揭露所屬領域具有通常知識者可明顯得知前述實施例僅為例示而非限制;本說明書中之各實施例可單獨實施或彼此結合;具本揭露所屬技術領域通常知識者可藉由諸多變換、替換而實施,並不與本揭露之技術特徵有所差異。依據說明書實施例,本揭露可有多種變換仍無礙於實施。本說明書提供之請求項界定本揭露之範圍,該範圍涵蓋前述方法與結構及與其相等之發明。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 examples rather than limitations; the various embodiments 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:用於收集人體與動物呼吸道病毒樣本之口罩 10:本體 101:摺痕 20:可撓構件 30:條帶 111:內層 112:樣本收集層 1121:收集區 113:中層 114:外層 L:長度 W:寬度 W’:第二寬度 100: Masks for collecting human and animal respiratory virus samples 10: Ontology 101: Crease 20: Flexible member 30: Strips 111: inner layer 112: Sample Collection Layer 1121: Collection area 113: Middle layer 114: Outer Layer L: length W: width W': second width
圖1係本揭露之用於收集人體與動物呼吸道病毒樣本之口罩之結構示意圖 圖2係圖1之口罩之部分剖面圖。 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:用於收集人體與動物呼吸道病毒樣本之口罩 100: Masks for collecting human and animal respiratory virus samples
10:本體 10: Ontology
101:摺痕 101: Crease
20:可撓構件 20: Flexible member
30:條帶 30: Strips
112:樣本收集層 112: Sample Collection Layer
1121:收集區 1121: Collection area
L:長度 L: length
W:寬度 W: width
W’:第二寬度 W': second width
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US20110030690A1 (en) * | 2009-05-18 | 2011-02-10 | Shukla Kavita M | Water absorbing face mask |
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