TW201912193A - Medicament delivery device comprising a wipe assembly - Google Patents
Medicament delivery device comprising a wipe assembly Download PDFInfo
- Publication number
- TW201912193A TW201912193A TW107129400A TW107129400A TW201912193A TW 201912193 A TW201912193 A TW 201912193A TW 107129400 A TW107129400 A TW 107129400A TW 107129400 A TW107129400 A TW 107129400A TW 201912193 A TW201912193 A TW 201912193A
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- delivery device
- drug delivery
- housing member
- sealing member
- sterile gauze
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/001—Apparatus specially adapted for cleaning or sterilising syringes or needles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
- A61M2205/0205—Materials having antiseptic or antimicrobial properties, e.g. silver compounds, rubber with sterilising agent
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2209/00—Ancillary equipment
- A61M2209/10—Equipment for cleaning
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/002—Packages specially adapted therefor, e.g. for syringes or needles, kits for diabetics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3202—Devices for protection of the needle before use, e.g. caps
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- Health & Medical Sciences (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
Description
本發明關於一種包含有擦拭組合體的藥物輸送裝置,特別是關於被密封構件保護的消毒紗布。The present invention relates to a drug delivery device comprising a wiping assembly, and more particularly to a sterile gauze protected by a sealing member.
現今之用於自我施藥的藥物輸送裝置需要可憑直覺操作且易於使用。為了改善病人對於給定處方的遵從性,重要的是他或她能夠依據處方適當地施用藥物,且能夠不需被要求研讀冗長的手冊就能施用藥物。 為了避免感染,在施用一劑量的藥物之前,清潔和消毒注射部位是有利的。但是使用者可能不見得能夠取得乾淨的水、肥皂、或其他清潔用品。因此,如果用於消毒注射部位的部件被包含在藥物輸送裝置內,則會比較方便。同時,重要的是不會在任何方面減少輸送裝置的功能或降低其吸引力。Today's drug delivery devices for self-administration require intuitive operation and ease of use. In order to improve patient compliance with a given prescription, it is important that he or she can properly administer the medication according to the prescription and that the medication can be administered without requiring a lengthy manual to be studied. In order to avoid infection, it is advantageous to clean and disinfect the injection site prior to administration of a dose of the drug. However, the user may not be able to obtain clean water, soap, or other cleaning products. Therefore, it is convenient if the components for sterilizing the injection site are contained in the drug delivery device. At the same time, it is important that the function of the conveyor is not reduced or its attractiveness is reduced in any way.
在本說明書中,當使用「遠側」一詞時,意指朝向遠離劑量輸送部位的方向。當使用「遠側部/端」一詞時,意指在使用藥物輸送裝置時,輸送裝置之位在最遠離劑量輸送部位的部分/端、或輸送裝置之構件的部分/端。對應地,當使用「近側」一詞時,意指朝向劑量輸送部位的方向。當使用「近側部/端」一詞時,意指在使用藥物輸送裝置時,輸送裝置之位在最接近劑量輸送部位的部分/端、或輸送裝置之構件的部分/端。 再者,「縱向」一詞,不管有沒有連同「軸線」一詞,都表示在裝置或其組件之最長延伸方向中穿過裝置或其組件的方向或軸線。 「側向」一詞,不管有沒有連同「軸線」一詞,都表示在裝置或其組件之最寬延伸方向中穿過裝置或其組件的方向或軸線。「側向」也可指「縱向」修長本體之側面的位置。 以類似的方式,「徑向」或「橫向」一詞,不管有沒有連同「軸線」一詞,都表示在大致垂直於縱的方向中穿過裝置或其組件的方向或軸線。例如「徑向朝外」意指朝向遠離縱向軸線的方向。 此外,若未特別說明,則下文所描述之裝置的機械構造和其組件的機械式互連,係指裝置在初始非啟動或非操作狀態。 有鑑於上文所述,本發明的一般目的,在於提供一種藥物輸送裝置,其包含擦式組合體。該擦式組合體易於使用且不減損輸送裝置的功能或外觀。 本發明之主要方面的特徵在於一種包含有殼體構件和擦式組合體的藥物輸送裝置。該擦式組合體包括消毒紗布和密封構件。其中該密封構件被附接至該殼體構件,和其中藉由該密封構件將該消毒紗布保持在密封隔室內。該密封隔室可被打開,以抽出該消毒紗布。 密封構件保護消毒紗布。消毒紗布是一件織物,因此密封構件和密封隔室也可具有小的剖面,其不會大幅改變藥物輸送裝置的外部形狀。密封隔室也可配置成被打開,以致於可容易抽出消毒紗布,並用於在藥物輸送之前清潔注射部位。 依據本發明的另一方面,殼體構件是藥物輸送裝置之外殼的一部份,以致於擦拭組合體可容易接觸藥物輸送裝置的外表面。 依據本發明的另一方面,殼體構件是藥物輸送裝置的可移除蓋件。就一些藥物輸送裝置而言,較佳是將擦拭組合體配置在可移除蓋件上。 依據本發明的另一方面,消毒紗布是濕的擦拭件。濕的擦拭件易於使用和生產。 依據本發明的另一方面,濕的擦拭件包括消毒物質,例如酒精或氯己定(chlorhexidine)。 依據本發明的另一方面,密封構件是可撓的黏性膜,可藉由從該殼體構件剝離黏性膜而移除密封構件,使得密封隔室被打開,以便能夠抽出消毒紗布。消毒紗布被保持在黏性膜和殼體構件之間的隔絕密封環境內,直到第一次移除黏性膜而打開密封隔室為止。在移除消毒紗布之後,黏性膜也可被再度附接至殼體構件,以復原殼體構件和黏性膜的外觀。 依據本發明的一取代性方面,密封構件是黏性的、可撓的塑膠囊袋,其形成密封隔室。可撓的塑膠囊袋可被打開,以便能夠抽出消毒紗布。消毒紗布被保持在塑膠囊袋內的隔絕密封環境中,直到塑膠囊袋被第一次打開為止。在移除消毒紗布之後,塑膠囊袋可被再度封閉,以復原殼體構件和塑膠囊袋的外觀。 依據本發明的另一方面,密封構件是藥物輸送裝置的黏性標籤。因此,標籤可遮住擦拭組合體。 依據本發明的另一方面,藥物輸送裝置是自動注射器、筆形注射器、或安全針筒。In the present specification, when the term "distal" is used, it means to face away from the dose delivery site. When the term "distal portion/end" is used, it is meant that when the drug delivery device is used, the delivery device is located at a portion/end that is furthest from the dose delivery site, or a portion/end of the component of the delivery device. Correspondingly, when the term "proximal" is used, it means the direction toward the dose delivery site. When the term "proximal portion/end" is used, it means that when the drug delivery device is used, the delivery device is located at the portion/end closest to the dose delivery site, or the portion/end of the member of the delivery device. Furthermore, the term "longitudinal", with or without the term "axis", refers to the direction or axis through which the device or its components are oriented in the longest direction of extension of the device or its components. The term "lateral", with or without the term "axis", means the direction or axis of the device or its components passing through the widest direction of extension of the device or its components. "Side" can also refer to the position of the side of the "longitudinal" slender body. In a similar manner, the term "radial" or "transverse", with or without the term "axis", refers to the direction or axis through which the device or its components are oriented generally perpendicular to the longitudinal direction. For example, "radially facing outward" means facing away from the longitudinal axis. Moreover, unless otherwise stated, the mechanical construction of the device described below and the mechanical interconnection of its components refer to the initial non-activated or inoperative state of the device. In view of the foregoing, it is a general object of the present invention to provide a drug delivery device comprising a wiper assembly. The wiper assembly is easy to use and does not detract from the function or appearance of the delivery device. A main aspect of the invention features a drug delivery device comprising a housing member and a wiper assembly. The wipe assembly includes a sterile gauze and a sealing member. Wherein the sealing member is attached to the housing member, and wherein the sterilizing gauze is retained within the sealed compartment by the sealing member. The sealed compartment can be opened to withdraw the sterile gauze. The sealing member protects the sterile gauze. The sterilizing gauze is a piece of fabric, so the sealing member and the sealed compartment can also have a small profile that does not significantly alter the outer shape of the drug delivery device. The sealed compartment can also be configured to be opened such that the sterile gauze can be easily withdrawn and used to clean the injection site prior to drug delivery. In accordance with another aspect of the invention, the housing member is part of the outer casing of the drug delivery device such that the wiping assembly readily contacts the outer surface of the drug delivery device. According to another aspect of the invention, the housing member is a removable cover of the drug delivery device. For some drug delivery devices, it is preferred to have the wiping assembly disposed on the removable cover member. According to another aspect of the invention, the sterilizing gauze is a wet wipe. Wet wipes are easy to use and produce. According to another aspect of the invention, the wet wipe comprises a disinfecting substance such as alcohol or chlorhexidine. According to another aspect of the invention, the sealing member is a flexible adhesive film that can be removed by peeling the adhesive film from the housing member such that the sealed compartment is opened so that the sterile gauze can be withdrawn. The sterilizing gauze is held in an isolated sealing environment between the viscous membrane and the housing member until the viscous membrane is removed for the first time to open the sealed compartment. After removal of the sterilizing gauze, the viscous film can also be reattached to the housing member to restore the appearance of the housing member and the viscous film. In accordance with an alternative aspect of the invention, the sealing member is a viscous, flexible plastic capsule that forms a sealed compartment. The flexible plastic capsule can be opened to enable the extraction of the sterile gauze. The sterilized gauze is held in an isolated sealed environment within the plastic capsule bag until the plastic capsule is opened for the first time. After removal of the sterile gauze, the plastic capsule bag can be resealed to restore the appearance of the housing member and the plastic capsule bag. According to another aspect of the invention, the sealing member is an adhesive label of a drug delivery device. Therefore, the label can cover the wiping assembly. According to another aspect of the invention, the drug delivery device is an autoinjector, a pen injector, or a safety syringe.
圖1a和1b顯示本發明的例示性實施例。其中的藥物輸送裝置10包含殼體構件15和擦式組合體。擦式組合體包括消毒紗布30和密封構件20。密封構件20被附接至殼體構件15,且消毒紗布30被密封構件20保持在密封隔室內。密封隔室可被打開,以抽出消毒紗布30。 在使用藥物輸送裝置刺穿使用者的皮膚之前,消毒紗布30是重要的,尤其是在容易孳生細菌之溫暖且潮濕的環境中。此等注射裝置可為無針的注射器或以針為主的注射裝置,亦即自動注射器、筆形注射器、安全針筒等。本發明的藥物輸送裝置較佳是單次使用的裝置。 例如圖1a和1b所示,殼體構件15可為藥物輸送裝置10的外殼。藥物輸送裝置的外殼通常是管狀塑膠外殼。當操作輸送裝置時,管狀塑膠外殼可被握持在使用者的手中。在另一實施例中,殼體構件15可為可移除蓋件(圖3a和3b),其覆蓋藥物輸送裝置10的注射針(未示)。 密封構件20可為單片式、非多孔、撓性、黏性膜,其包括沿著其邊緣的黏性表面25。在另一實施例中,密封構件20可包括雙片式、非多孔、黏性、撓性塑膠囊袋。如圖2a和2b所示,該塑膠囊袋包括沿著兩片體之相互面對的兩邊緣的黏性表面25,用於密封該囊袋。 大體而言,藉由密封構件20來形成密封隔室,使得密封隔室沿著殼體構件15的表面大致平坦。因此消毒紗布30可被單片式密封構件20直接保持抵靠著殼體構件15。藉此,密封構件20的黏性表面25將消毒紗布30包覆在殼體構件15和密封構件20之間。在另一實施例中,雙片式密封構件可為黏性、撓性塑膠囊袋,其藉由黏性表面25形成在兩片體之間的密封隔室或囊袋。包含有消毒紗布的黏性囊袋可被附接至殼體構件15。 因為擦拭組件係平坦地抵靠著殼體構件15的表面,所以密封構件可有利地包括藥物輸送裝置10的標籤。該標籤可含有標識語、或文字(例如使用者的指示)、或影像。 消毒紗布30可為濕的擦式件,其包含消毒物質,例如酒精或氯己定(chlorhexidine)。密封構件20可將消毒紗布30密封在密封隔室內而與外界隔絕,直到該隔室第一次被打開為止。如圖3a和3b所例示的唇部27可被設置供使用者打開由密封構件20所形成的密封隔室。在單片式密封構件的情況中,黏性膜被從殼體構件15剝離;而在兩片式囊袋的情況中,未被附接至殼體構件的片體被從附接至殼體構件的片體剝離,以打開囊帶(亦即密封隔室)。 較佳地,在抽出消毒紗布30之後,黏性表面允許隔室再度被封閉,使得藥物輸送裝置10的外觀不會被打開的隔室所影響或減損。當密封構件20包含標籤時,外觀特別重要。在再度封閉隔室之前,也可將隔室內的消毒紗布當作垃圾放回隔室內,以便稍後和使用過的藥物輸送裝置一起丟棄。 在施用一劑量的藥物之前,使用者例如藉由拉動密封構件20的唇部27來打開密封隔室。使用者從隔室抽出消毒紗布30,並使用紗布來清潔注射部位的皮膚。然後考慮消耗消毒紗布,且可在再度關閉隔室之前將紗布放回隔室內或丟棄。接下來,藥物輸送裝置10可被啟動,並用於穿刺注射部位的皮膚,而沒有感染使用者的風險。在使用之後,可以安全的方式丟棄藥物輸送裝置10,例如丟在尖銳物件桶內。Figures 1a and 1b show an exemplary embodiment of the invention. The drug delivery device 10 therein includes a housing member 15 and a wiper assembly. The wipe assembly includes a sterile gauze 30 and a sealing member 20. The sealing member 20 is attached to the housing member 15, and the sterilizing gauze 30 is held within the sealed compartment by the sealing member 20. The sealed compartment can be opened to withdraw the sterile gauze 30. Disinfecting the gauze 30 is important prior to piercing the user's skin with a drug delivery device, especially in a warm and humid environment where bacteria are susceptible to bacteria. These injection devices may be needle-free syringes or needle-based injection devices, that is, auto-injectors, pen-shaped syringes, safety syringes, and the like. The drug delivery device of the present invention is preferably a single use device. For example, as shown in Figures 1a and 1b, the housing member 15 can be the outer casing of the drug delivery device 10. The outer casing of the drug delivery device is typically a tubular plastic outer casing. The tubular plastic outer casing can be held in the user's hand when the conveyor is operated. In another embodiment, the housing member 15 can be a removable cover (Figs. 3a and 3b) that covers an injection needle (not shown) of the drug delivery device 10. Sealing member 20 can be a one-piece, non-porous, flexible, viscous film that includes a viscous surface 25 along its edges. In another embodiment, the sealing member 20 can comprise a two-piece, non-porous, viscous, flexible plastic capsule. As shown in Figures 2a and 2b, the plastic capsule bag includes an adhesive surface 25 along the mutually facing edges of the two sheets for sealing the bladder. In general, the sealed compartment is formed by the sealing member 20 such that the sealed compartment is substantially flat along the surface of the housing member 15. Thus the sterile gauze 30 can be held directly against the housing member 15 by the one-piece sealing member 20. Thereby, the viscous surface 25 of the sealing member 20 encloses the sterilizing gauze 30 between the housing member 15 and the sealing member 20. In another embodiment, the two-piece sealing member can be a viscous, flexible plastic capsule that is formed by a viscous surface 25 in a sealed compartment or pocket between the two sheets. A viscous bladder containing sterile gauze can be attached to the housing member 15. Because the wiping assembly is flat against the surface of the housing member 15, the sealing member can advantageously include a label for the drug delivery device 10. The tag may contain a logo, or text (eg, a user's indication), or an image. The sterilizing gauze 30 can be a wet wipe that contains a sterilizing substance such as alcohol or chlorhexidine. The sealing member 20 seals the sterile gauze 30 within the sealed compartment from the outside until the compartment is first opened. The lip 27 as illustrated in Figures 3a and 3b can be provided for a user to open a sealed compartment formed by the sealing member 20. In the case of a one-piece sealing member, the viscous film is peeled off from the housing member 15; and in the case of a two-piece capsular bag, the sheet that is not attached to the housing member is attached from the housing to the housing The sheet of the member is peeled off to open the capsule (i.e., the sealed compartment). Preferably, after the sterile gauze 30 is withdrawn, the viscous surface allows the compartment to be closed again so that the appearance of the drug delivery device 10 is not affected or compromised by the open compartment. The appearance is particularly important when the sealing member 20 contains a label. The sterile gauze in the compartment can also be returned to the compartment as waste before it is closed again for later disposal with the used drug delivery device. The user opens the sealed compartment, for example by pulling the lip 27 of the sealing member 20, prior to administering a dose of the drug. The user withdraws the sterile gauze 30 from the compartment and uses gauze to clean the skin at the injection site. Then consider consuming the sterile gauze and returning the gauze back to the compartment or discarding it before closing the compartment again. Next, the drug delivery device 10 can be activated and used to puncture the skin of the injection site without the risk of infecting the user. After use, the drug delivery device 10 can be discarded in a safe manner, such as in a sharp object bucket.
10‧‧‧藥物輸送裝置10‧‧‧Drug delivery device
15‧‧‧殼體構件15‧‧‧Shell components
20‧‧‧密封構件20‧‧‧ Sealing members
25‧‧‧黏性表面25‧‧‧ Viscous surface
27‧‧‧唇部27‧‧‧Lip
30‧‧‧消毒紗布30‧‧‧Disinfecting gauze
圖1a和1b顯示本發明之實施例的概念化透視圖。 圖2a和2b顯示本發明之實施例的詳細視圖。 圖3a和3b顯示本發明之取代性實施例的透視圖。Figures 1a and 1b show conceptual perspective views of an embodiment of the invention. Figures 2a and 2b show detailed views of an embodiment of the invention. Figures 3a and 3b show perspective views of an alternative embodiment of the invention.
Claims (16)
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WO2022146683A1 (en) * | 2020-12-31 | 2022-07-07 | Becton, Dickinson And Company | An accessory for a medical device to disinfect a skin surface |
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US4243035A (en) * | 1979-06-18 | 1981-01-06 | Barrett Howard G | Syringe with integral swab |
US7393345B2 (en) * | 2003-07-18 | 2008-07-01 | Chang-Ming Yang | Sterilized safety syringe |
US20070167917A1 (en) * | 2006-01-19 | 2007-07-19 | Lee David H | Disposable syringe with a swab pack |
US20080039803A1 (en) * | 2006-08-09 | 2008-02-14 | Lawrence Allan Lynn | Luer protection pouch™ and luer valve/male luer protection method |
GB0819161D0 (en) * | 2008-10-18 | 2008-11-26 | Frontier Plastics Ltd | Improvements in and relating to injection syringes |
US9125600B2 (en) * | 2009-06-29 | 2015-09-08 | Gregory A. Steube | Medical device with incorporated disinfecting wipe and method of using same |
CN108601901B (en) * | 2015-11-27 | 2021-02-26 | 赛诺菲-安万特德国有限公司 | Drug delivery device with cap |
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2018
- 2018-08-23 TW TW107129400A patent/TW201912193A/en unknown
- 2018-08-28 WO PCT/EP2018/073111 patent/WO2019042987A1/en active Application Filing
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WO2019042987A1 (en) | 2019-03-07 |
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