CN111467231A - A kind of closed-type compounding device for antitumor drug and using method thereof - Google Patents
A kind of closed-type compounding device for antitumor drug and using method thereof Download PDFInfo
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- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
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- A—HUMAN NECESSITIES
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- A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
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- A—HUMAN NECESSITIES
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Abstract
本发明涉及医疗器械领域,公开了一种用于抗肿瘤药物的密闭式配制装置及其使用方法,包括筒体和套帽,筒体的内壁设置有凸缘,凸缘由具有弹性的材料制得;套帽顶部中间固定有连接管,靠近套帽的连接管端头同轴设置有注射针管,注射针管的针尖穿过套帽的顶盖并延伸至筒体中部位置;远离套帽的连接管端头设置有针栓,注射针管和针栓均与连接管的内腔连通。本发明通过将西林瓶插入筒体内并使套帽内侧的注射针管刺入西林瓶内,利用筒体内的凸缘将西林瓶颈部卡住,通过注射针管向西林瓶内注入溶媒液体,然后手持筒体对西林瓶内的药剂进行摇匀,过程中可以防止西林瓶内的液体飞溅到空气中,防止药物对医务人员黏膜或皮肤的损伤,也避免了针刺伤的发生。
The invention relates to the field of medical devices, and discloses a closed-type compounding device for antitumor drugs and a method for using the same. ; A connecting tube is fixed in the middle of the top of the cap, and an injection needle tube is coaxially arranged near the end of the connecting tube of the cap, and the needle tip of the injection needle tube passes through the top cover of the cap and extends to the middle of the cylinder; the connecting tube away from the cap The end is provided with a needle plug, and both the injection needle tube and the needle plug are communicated with the inner cavity of the connecting tube. In the present invention, the vial is inserted into the cylinder and the injection needle tube inside the cap is inserted into the vial, the flange in the cylinder is used to clamp the neck of the vial, the solvent liquid is injected into the vial through the injection needle, and then the cylinder is held by hand. Body shakes the medicine in the vial, which can prevent the liquid in the vial from splashing into the air during the process, prevent the drug from damaging the mucous membrane or skin of the medical staff, and avoid the occurrence of needle stick injuries.
Description
技术领域technical field
本发明涉及医疗器械领域,具体涉及一种用于抗肿瘤药物的密闭式配制装置及其使用方法。The invention relates to the field of medical devices, in particular to a closed-type compounding device for antitumor drugs and a method for using the same.
背景技术Background technique
西林瓶是用于盛装粉状或液体药剂的小型玻璃容器,其结构包括瓶体和瓶头,以及位于瓶体、瓶头之间凹陷部分的颈部,容量一般为1~20ml,一般用于注射用药液或药粉,瓶头的瓶盖一般采用橡胶制成胶塞,在胶塞外还套设有一层金属铝箔密封。The vial is a small glass container used to hold powder or liquid medicine. Its structure includes a bottle body, a bottle head, and a neck located in the concave part between the bottle body and the bottle head. The capacity is generally 1-20ml. It is generally used for For injection of medicinal liquid or medicinal powder, the cap of the bottle head is generally made of rubber as a rubber stopper, and a layer of metal aluminum foil is also set outside the rubber stopper to seal.
目前,采用传统配药方式对西林瓶内抗肿瘤药物配制时,一般先利用注射器从输液袋或输液瓶中抽吸溶媒,再将注射器的针头插入西林瓶将药液注入西林瓶,人工手持西林瓶对瓶内药液左右摇匀,然后再将针头插入西林瓶内倒置西林瓶,将西林瓶内药液抽吸出来;抽吸完成的注射器将其内的药液注入输液袋中,拔出注射器,最终完成西林瓶内药液或药粉的转移配药。这种利用手持注射器人工注入和抽吸西林瓶内药液或药粉,然后将注射器插入输液袋并将药液注入输液袋的配药方法,操作步骤繁琐、耗时低效,且手持注射器对西林瓶进行抽吸或对输液袋进行注液的方式存在发生针刺伤、药物分子弥散在空气中致使医务人员暴露其中的风险。根据相关文献记载,尤其是化疗药物对正常人体皮肤黏膜、骨髓细胞、生殖系统等多方面均存在危害,加之配置生物配药柜成本极高,造成其普及率低等因素。综上,长期以往,抗肿瘤药物分子的暴露对医护人员存在伤害不可估量。At present, when using traditional dispensing methods to prepare antitumor drugs in vials, a syringe is generally used to draw the solvent from the infusion bag or infusion bottle, and then the needle of the syringe is inserted into the vial to inject the drug into the vial, and the vial is manually held by hand. Shake the liquid in the bottle from side to side, then insert the needle into the vial and invert the vial, and suck out the liquid in the vial; after the suction is completed, inject the liquid in the syringe into the infusion bag, and pull out the syringe , and finally complete the transfer and dispensing of the medicinal liquid or medicinal powder in the vial. This dispensing method of manually injecting and sucking the medicinal liquid or medicinal powder in the vial by using a hand-held syringe, then inserting the syringe into the infusion bag and injecting the medicinal liquid into the infusion bag, has complicated operation steps, time-consuming and inefficient, and the hand-held syringe is not effective for the vial. The way in which suction is performed or the infusion bag is filled carries the risk of needle stick injuries and the dispersion of drug molecules in the air, exposing medical personnel to it. According to relevant literature records, chemotherapy drugs, in particular, are harmful to normal human skin and mucous membranes, bone marrow cells, reproductive system, etc. In addition, the cost of configuring biological dispensing cabinets is extremely high, resulting in a low penetration rate and other factors. To sum up, in the long term, the exposure of antitumor drug molecules has caused immeasurable harm to medical staff.
根据世界卫生组织《2014年全球肿瘤报告》,医护人员在救治患者的过程中面临危险药物暴露的风险。预计到2015年,中国将有1069万医护工作者受到危险药物暴露的威胁。2016年,美国药典大会对危险药物的处理进行详细规定,并于2018年正式纳入职业安全计划。美国要求于2018年开始所有的配药系统在条件允许的情况下尽量使用密闭式药物配置和转运系统(closed-system drug transfer device,CSTD)。目前国外常用的CSTD有:PhaSeal(碧安思TM),Chemoclave,Chemoprotect,Halo系统等,这些设备被证明有助于减少抗肿瘤药物的污染,其中以美国BD PhaSeal(碧安思TM)系统的研究最广泛,然该系统价格高昂、操作繁琐。加之根据中国医师协会介入医师分会于2019年发布的《中国肝细胞经动脉化疗栓塞治疗临床实践指南》中提出:肝细胞癌(HCC)是起源于肝细胞的恶性肿瘤,中国HCC患者80%发生于乙型肝炎病毒(HBV)感染后。HCC通常是一种富血供肿瘤,经动脉灌注化疗栓塞(TACE)治疗一方面阻断肿瘤血供,同时在肿瘤局部聚集高浓的化疗药物,对肿瘤细胞发挥最大限度的杀伤作用,被公认为HCC非手术治疗常用方法之一,因此,在具备同等效能的情况下,更经济更便捷的CSTD无疑将减轻我国肝癌患者进行TACE手术的经济负担以及降低肿瘤相关医护人员工作配制抗肿瘤药物的心理和身体负担。故此,提出该项具备我国特色的经济型一次性抗肿瘤药物密闭式配制装置的需求是迫切的。According to the World Health Organization's Global Oncology Report 2014, healthcare workers face the risk of exposure to dangerous drugs while caring for patients. It is estimated that by 2015, 10.69 million healthcare workers in China will be at risk of exposure to dangerous drugs. In 2016, the United States Pharmacopeia Congress made detailed regulations on the handling of dangerous drugs, and in 2018, it was officially included in the occupational safety program. The United States requires that all dispensing systems should use a closed-system drug transfer device (CSTD) as much as possible in 2018. At present, the commonly used CSTD abroad are: PhaSeal ( BiansiTM ), Chemoclave, Chemoprotect, Halo system, etc. These devices have been proved to help reduce the pollution of anti-tumor drugs. Among them, the American BD PhaSeal ( BiansiTM ) system has The most widely studied, however, the system is expensive and cumbersome to operate. In addition, according to the "Clinical Practice Guidelines for Hepatocyte Transarterial Chemoembolization in China" issued by the Interventional Physician Branch of the Chinese Medical Doctor Association in 2019, it is proposed that hepatocellular carcinoma (HCC) is a malignant tumor originating from hepatocytes, and 80% of Chinese HCC patients occur. after hepatitis B virus (HBV) infection. HCC is usually a tumor with a rich blood supply. Transarterial chemoembolization (TACE) treatment on the one hand blocks the blood supply of the tumor, and at the same time accumulates highly concentrated chemotherapeutic drugs locally in the tumor, which exerts the maximum killing effect on tumor cells. It is recognized that It is one of the common methods for non-surgical treatment of HCC. Therefore, with the same efficacy, a more economical and more convenient CSTD will undoubtedly reduce the economic burden of TACE surgery for liver cancer patients in my country and reduce the work of tumor-related medical staff to formulate anti-tumor drugs. Mental and physical burden. Therefore, it is urgent to propose this economical disposable anti-tumor drug closed-type compounding device with Chinese characteristics.
发明内容SUMMARY OF THE INVENTION
基于以上问题,本发明提供一种用于抗肿瘤药物的密闭式配制装置及其使用方法,通过将西林瓶插入筒体内并使套帽内侧的注射针管刺入西林瓶内,利用筒体内的凸缘将西林瓶颈部卡住,通过注射针管向西林瓶内注入溶媒液体,然后手持筒体对西林瓶内的药剂进行摇匀,过程中可以防止西林瓶内的液体飞溅到空气中,防止药物对医务人员黏膜或皮肤的损伤,也避免了针刺伤的发生。Based on the above problems, the present invention provides a closed-type compounding device for antitumor drugs and a method for using the same. The edge of the bottle is stuck at the neck of the vial, and the solvent liquid is injected into the vial through the injection needle, and then the medicine in the vial is shaken by the cylinder. The injury of mucous membranes or skin of medical staff also avoids the occurrence of needle stick injuries.
为解决上述技术问题,本发明所采用的技术方案是:For solving the above-mentioned technical problems, the technical scheme adopted in the present invention is:
一种用于抗肿瘤药物的密闭式配制装置,包括两端为敞口且内径大于西林瓶外径的筒体,筒体的一端设置有可对筒体端头进行盖封的套帽,筒体的内壁设置有可卡住西林瓶颈部的凸缘,凸缘位于靠近带有套帽的筒体端头位置,凸缘由具有弹性的材料制得;套帽一端开口,另一端带有顶盖,套帽顶部中间固定有连接管;靠近套帽的连接管端头同轴设置有注射针管,注射针管的中轴线与筒体的中轴线位于同一直线上,注射针管的针尖穿过套帽的顶盖并延伸至筒体中部位置;远离套帽的连接管端头设置有可与注射器乳头套接的针栓,注射针管和针栓均与连接管的内腔连通。A closed-type compounding device for antitumor drugs, comprising a cylinder with open ends at both ends and an inner diameter larger than the outer diameter of the vial, one end of the cylinder is provided with a cap that can cover the end of the cylinder, and the cylinder is The inner wall of the body is provided with a flange that can clamp the bottle neck of the cylin, the flange is located near the end of the cylinder with a cap, and the flange is made of elastic material; one end of the cap is open, and the other end is provided with a top cover , a connecting tube is fixed in the middle of the top of the cap; the end of the connecting tube near the cap is coaxially provided with an injection needle, the central axis of the injection needle and the central axis of the barrel are on the same line, and the needle tip of the injection needle passes through the cap. The top cover extends to the middle of the barrel; the end of the connecting pipe far from the cap is provided with a needle plug that can be sleeved with the nipple of the syringe, and the injection needle and the needle plug are both communicated with the inner cavity of the connecting pipe.
进一步地,套帽内壁靠近顶盖的位置设置有缩口段,套帽内壁靠近开口的位置设置有内螺纹;套帽对应的筒体外壁位置设置有与内螺纹相匹配的螺纹,套帽对应的筒体端头位置沿筒体轴向设置有多个缺口槽,缺口槽的长度大于凸缘到带有套帽的筒体端头长度,缺口槽将筒体端头均匀分割为多个带有凸缘的卡口片。Further, the position of the inner wall of the cap close to the top cover is provided with a constricted section, and the position of the inner wall of the cap close to the opening is provided with an internal thread; the position of the outer wall of the cylinder corresponding to the cap is provided with a thread matching the internal thread, and the cap corresponds to The position of the end of the cylinder body is provided with a plurality of notch grooves along the axial direction of the cylinder body, the length of the notch groove is greater than the length from the flange to the end of the cylinder body with the sleeve cap, and the notch groove evenly divides the end of the cylinder body into a plurality of belts. Flanged bayonet tab.
进一步地,连接管中部通过三通阀连接有导管接头,三通阀的控制旋钮上设置有用于指示连通方向的指针。Further, the middle part of the connecting pipe is connected with a conduit joint through a three-way valve, and a pointer for indicating the communication direction is provided on the control knob of the three-way valve.
进一步地,注射器的乳头外壁与针栓内壁通过螺纹连接。Further, the outer wall of the nipple of the syringe and the inner wall of the needle plug are connected by threads.
进一步地,套帽与筒体均采用透明材质制得。Further, both the cap and the cylinder are made of transparent materials.
进一步地,注射针管侧壁设置有贯穿注射针管管壁的通孔,通孔位于注射针管上靠近针尖的位置,且通孔与针尖之间的距离大于等于西林瓶瓶盖的厚度。Further, the side wall of the injection needle tube is provided with a through hole passing through the wall of the injection needle tube, the through hole is located on the injection needle tube near the needle tip, and the distance between the through hole and the needle tip is greater than or equal to the thickness of the vial cap.
进一步地,注射针管内腔中设置有可供介质由注射针管内腔流向针尖方向的单向气阀,单向气阀位于通孔与针尖之间。Further, the inner cavity of the injection needle tube is provided with a one-way air valve for the medium to flow from the inner cavity of the injection needle tube to the direction of the needle tip, and the one-way air valve is located between the through hole and the needle tip.
进一步地,单向气阀为鸭嘴阀,鸭嘴阀包括可固定于注射针管内腔的内管,内管由弹性材料制得,内管的直径等于注射针管的内径,内管靠近针尖的端口边缘呈接触闭合的V型结构,V型结构的尖部朝向注射针管的针尖方向。Further, the one-way air valve is a duckbill valve, the duckbill valve includes an inner tube that can be fixed in the inner cavity of the injection needle tube, the inner tube is made of elastic material, the diameter of the inner tube is equal to the inner diameter of the injection needle tube, and the inner tube is close to the needle tip. The edge of the port is a V-shaped structure with contact closure, and the tip of the V-shaped structure faces the direction of the needle tip of the injection needle.
为解决上述技术问题,本发明还提供了一种用于抗肿瘤药物的密闭式配制装置的使用方法,包括如下步骤:In order to solve the above-mentioned technical problems, the present invention also provides a method for using a closed-type compounding device for antitumor drugs, comprising the following steps:
S1、将带有瓶盖的西林瓶端头由筒体不带套帽的敞口端插入筒体内,推挤西林瓶使筒体内凸缘卡住西林瓶的颈部,并使套帽内侧的注射针管的尖部逐渐插入西林瓶内腔中,并保持通孔位于西林瓶外,进行西林瓶内气压的平衡;S1. Insert the end of the vial with the cap into the cylinder from the open end of the cylinder without the cap, push the vial to make the flange in the cylinder clamp the neck of the vial, and make the inner side of the cap clamp the vial. The tip of the injection needle is gradually inserted into the inner cavity of the vial, and the through hole is kept outside the vial to balance the air pressure in the vial;
S2、逐渐将注射针管刺入西林瓶中至通孔位于西林瓶内腔且靠近瓶盖内壁的位置,将抽取好溶媒液体的注射器乳头插入针栓内,推挤注射器的活塞推杆使注射器内的溶媒液体依次经连接管内腔、注射针管进入西林瓶内;S2. Gradually insert the injection needle into the vial until the through hole is located in the inner cavity of the vial and close to the inner wall of the cap, insert the syringe nipple from which the solvent liquid has been extracted into the needle plug, and push the plunger rod of the syringe to make the inside of the syringe The solvent liquid enters the vial through the lumen of the connecting tube and the injection needle in turn;
S3、手持注射器、套帽及筒体并对西林瓶内的药物进行摇匀,使筒体内西林瓶中的药物充分混合溶解,然后将筒体倒置使西林瓶的瓶盖朝下,拉动注射器的活塞推杆,将西林瓶内混合好的药物抽至注射器内。S3. Hold the syringe, the cap and the cylinder and shake the medicine in the vial to make the medicine in the vial in the cylinder fully mixed and dissolved, then invert the cylinder so that the cap of the vial faces down, and pull the side of the syringe. Push the piston rod to draw the mixed drug in the vial into the syringe.
进一步地,连接管中部通过三通阀连接有导管接头,在西林瓶内混合好的药物抽至注射器后,调节三通阀使注射器—连接管—导管接头处于通路状态,再通过推动注射器的活塞推杆将注射器内已经配制好的药物经导管接头转移至输液袋、输液瓶或者其他药物中转输送设备中,使化疗药物整个配置过程药物都处于密封环境。Further, the middle part of the connecting pipe is connected with a catheter joint through a three-way valve. After the mixed medicine in the vial is pumped to the syringe, the three-way valve is adjusted to make the syringe-connecting pipe-catheter joint in a passage state, and then push the piston of the syringe. The push rod transfers the prepared drug in the syringe to the infusion bag, infusion bottle or other drug transfer and delivery equipment through the catheter connector, so that the drug is in a sealed environment during the entire configuration process of the chemotherapeutic drug.
与现有技术相比,本发明的有益效果是:Compared with the prior art, the beneficial effects of the present invention are:
1.本发明通过将西林瓶插入筒体内并使套帽内侧的注射针管刺入西林瓶内,利用筒体内的凸缘将西林瓶颈部卡住,通过注射针管向西林瓶内注入溶媒液体,然后手持筒体对西林瓶内的药剂进行摇匀,过程中可以防止西林瓶内的液体飞溅到空气中,防止药物对医务人员黏膜或皮肤的损伤,也避免了针刺伤的发生。1. The present invention inserts the vial into the cylinder and inserts the injection needle inside the cap into the vial, utilizes the flange in the cylinder to clamp the neck of the vial, injects the solvent liquid into the vial through the injection needle, and then Shake the medicine in the vial by holding the cylinder. During the process, it can prevent the liquid in the vial from splashing into the air, prevent the medicine from damaging the mucous membranes or skin of the medical staff, and avoid the occurrence of needle stick injuries.
2.利用套帽旋紧筒体的卡口片,实现对西林瓶的固定,进一步防止摇匀药物时西林瓶从筒体内甩出。2. Use the cap to tighten the bayonet piece of the cylinder to fix the vial and further prevent the vial from being thrown out of the cylinder when the medicine is shaken.
3.在连接管上增设三通阀和导管接头,通过控制三通阀从而实现溶媒液体注入、药物抽吸以及药物转移过程中管路的通断,整个过程药物处于密闭环境,同时也减少了不必要的插拔管路,进一步防止药物飞溅或滴落。3. Add a three-way valve and a conduit joint on the connecting pipe, and control the three-way valve to realize the on-off of the solvent liquid injection, drug suction and drug transfer process. The drug is in a closed environment during the whole process, and it also reduces Unnecessary plugging and unplugging of lines further prevents drug splashing or dripping.
4.注射针管上管壁上设置通孔,一是可以在注射针管刺入过程中,通过通孔平衡西林瓶内的气压,规避了后续药物抽吸过程中西林瓶内存在负压造成抽吸阻力较大的问题;二是在西林瓶倒置进行药物抽吸过程中,使通孔位于靠近西林瓶瓶盖内壁的位置,使得药物能够被完全抽吸,确保药物用量。4. A through hole is set on the upper tube wall of the injection needle. First, the air pressure in the vial can be balanced through the through hole during the piercing of the injection needle, avoiding the negative pressure in the vial during the subsequent drug suction process. The problem is that the resistance is relatively large; the second is that in the process of drug suctioning by inverting the vial, the through hole is located close to the inner wall of the vial cap, so that the drug can be completely sucked and the dosage of the drug is ensured.
5.注射针管的针尖与通孔之间的位置设置单向气阀,保证西林瓶内药物液面低于针尖部位时,西林瓶内的空气不会随药物抽出,规避了需要医务人员进行反复排气、以及产生气溶胶污染的问题。5. A one-way air valve is set between the needle tip and the through hole of the injection needle to ensure that when the liquid level of the drug in the vial is lower than the needle tip, the air in the vial will not be drawn out with the drug, avoiding the need for medical staff to repeat Exhaust gas, and the problem of generating aerosol pollution.
附图说明Description of drawings
图1为实施例1和2中用于化疗药物的配药装置的立体结构示意图;Fig. 1 is the three-dimensional structure schematic diagram of the dispensing device for chemotherapeutic drugs in
图2为实施例1和2中利用注射针管上的通孔平衡气压时注射针管相对西林瓶的位置示意图;2 is a schematic diagram of the position of the injection needle tube relative to the vial when the through hole on the injection needle tube is used to balance the air pressure in
图3为实施例1和2中西林瓶倒置利用通孔抽吸药物时注射针管相对西林瓶的位置示意图;Fig. 3 is a schematic diagram of the position of the injection needle relative to the vial when the vial is inverted in
图4为实施例1和2中注射针管上通孔及单向气阀的位置关系示意图;4 is a schematic diagram of the positional relationship between the through hole and the one-way air valve on the injection needle in
图5为实施例1和2中气流由V型结构尖部接触闭合部位进入西林瓶内时鸭嘴阀的结构示意图;Fig. 5 is the structural representation of the duckbill valve when the air flow enters the vial from the V-shaped structure tip contacting the closed part in Examples 1 and 2;
其中:1、西林瓶;2、筒体;3、套帽;4、凸缘;5、连接管;6、注射针管;7、针栓;8、缩口段;9、卡口片;10、三通阀;11、导管接头;12、通孔;13、鸭嘴阀;14、注射器。Among them: 1. Vial; 2. Cylinder; 3. Cap; 4. Flange; 5. Connecting tube; 6. Injection needle; 7. Needle plug; , Three-way valve; 11, conduit joint; 12, through hole; 13, duckbill valve; 14, syringe.
具体实施方式Detailed ways
为使本发明的目的、技术方案和优点更加清楚明白,下面结合实施例和附图,对本发明作进一步的详细说明,本发明的示意性实施方式及其说明仅用于解释本发明,并不作为对本发明的限定。In order to make the purpose, technical solutions and advantages of the present invention clearer, the present invention will be further described in detail below with reference to the embodiments and the accompanying drawings. as a limitation of the present invention.
实施例1:Example 1:
参见图1-3,一种用于抗肿瘤药物的密闭式配制装置,包括两端为敞口且内径大于西林瓶1外径的筒体2,筒体2的一端设置有可对筒体2端头进行盖封的套帽3,筒体2的内壁设置有可卡住西林瓶1颈部的凸缘4,凸缘4位于靠近带有套帽3的筒体2端头位置,凸缘4由具有弹性的材料制得;套帽3一端开口,另一端带有顶盖,套帽3顶部中间固定有连接管5;靠近套帽3的连接管5端头同轴设置有注射针管6,注射针管6的中轴线与筒体2的中轴线位于同一直线上,注射针管6的针尖穿过套帽3的顶盖并延伸至筒体2中部位置;远离套帽3的连接管5端头设置有可与注射器14乳头套接的针栓7,注射针管6和针栓7均与连接管5的内腔连通。Referring to Figures 1-3, a closed-type compounding device for antineoplastic drugs includes a
在本实施例中,需要用西林瓶1配置药物时,预先用注射器14抽取配置药物需要的溶媒液体,然后调整西林瓶1的瓶盖与筒体2的套帽3朝向相同,将带有瓶盖的西林瓶1一端由筒体2不带套帽3的敞口端插入筒体2内,用力推挤西林瓶1使筒体2内凸缘4卡住西林瓶1的颈部,在推挤西林瓶1的过程中,套帽3内侧的注射针管6逐渐插入西林瓶1内腔中。然后将抽取好溶媒液体的注射器14乳头插入针栓7内,通过推挤注射器14的活塞推杆使注射器14内的溶媒液体依次经连接管5内腔、注射针管6进入西林瓶1内;然后手持注射器14、套帽3及筒体2并摇匀,使筒体2内西林瓶1中的药物充分混合溶解,然后拉动注射器14的活塞推杆,将西林瓶1内混合好的药物抽至注射器14内,实现西林瓶1内药物的混合配置。药物配置摇匀过程中,因溶媒液体注入或摇匀时药物由注射针管6与西林瓶1瓶盖之间的间隙可能会漏出药物液体,但本实施例中的西林瓶1在药物配置的整个过程(特别是摇匀时)处于筒体2内,并用套帽3进行封盖,不会使漏出的药物液体飞溅到医务人员的皮肤上或弥散在空气中,特别是化疗药物或一些对皮肤有损伤作用的药物,可以起到很好的防护作用。同时,筒体2内的凸缘4卡柱西林瓶1的颈部,使得西林瓶1不易脱离筒体2内而被甩出,保证药物配置过程顺利进行。In this embodiment, when the
套帽3内壁靠近顶盖的位置设置有缩口段8,套帽3内壁靠近开口的位置设置有内螺纹;套帽3对应的筒体2外壁位置设置有与内螺纹相匹配的螺纹,套帽3对应的筒体2端头位置沿筒体2轴向设置有多个缺口槽,缺口槽的长度大于凸缘4到带有套帽3的筒体2端头长度,缺口槽将筒体2端头均匀分割为多个带有凸缘4的卡口片9。本实施例中,套帽3与筒体2通过螺纹连接,药物摇匀过程中,可以防止套帽3与筒体2互相脱离而使筒体2被甩出。在套帽3与筒体2通过螺纹旋紧过程中,带有缺口槽的筒体2端头与套帽3内的缩口段8接触后,缩口段8会逐渐对各个卡口片9产生推力作用,使各个卡口片9逐渐向筒体2中轴线靠拢,此时凸缘4或者卡口片9的内壁会对西林瓶1的颈部或者西林瓶1瓶身侧壁产生握裹力,将西林瓶1牢牢卡在筒体2内,进一步防止药物摇匀过程中西林瓶1被甩出。此外注射器14的乳头外壁与所述针栓7内壁通过螺纹连接,可以保证摇匀过程中针栓7不会因压力变化而与注射器14分离。The position of the inner wall of the
连接管5中部通过三通阀10连接有导管接头11,本实施例中的导管接头11用于将注射器14内已经配置好的药物转移至输液袋、输液瓶或者其他药物中转输送设备中,或根据需要在导管接头11前端设置注射针直接对患者进行注射,整个操作过程药物都处于密封环境,减少中间过程中注射器14或输送管道的插拔,进一步防止药物转移过程中药物滴落或飞溅。The middle of the connecting
三通阀10的操作顺序为:在西林瓶1推入筒体2内注射针管6插入西林瓶1后,调整三通阀10的控制旋钮,使针栓7(注射器14)—连接管5—注射针管6处于通路,导管接头11与连接管5处于断路状态,然后将注射器14内的溶媒液体注入西林瓶1内,并进行摇匀使西林瓶1内的药剂溶解完全;保持使针栓7—连接管5—注射针管6通路,导管接头11与连接管5处于断路状态,用注射器14将西林瓶1内的药物抽出至注射器14内;然后调节三通阀10的控制旋钮,使针栓7(注射器14)—连接管5—导管接头11处于通路,注射针管6与连接管5处于断路状态,然后将注射器14内的药物推出至导管接头11,并由导管接头11导入至相应的设备或直接注射至患者体内。本实施例中三通阀10的控制旋钮上设置有用于指示连通方向的指针,可以使医务人员直观快速地确定三通阀10的通断路径,方便医务人员操作。The operation sequence of the three-way valve 10 is as follows: after the vial 1 is pushed into the cylinder 2 and the injection needle 6 is inserted into the vial 1, the control knob of the three-way valve 10 is adjusted so that the needle plug 7 (syringe 14)—the connecting pipe 5— The injection needle 6 is in the passageway, the catheter joint 11 and the connecting pipe 5 are in an open circuit state, and then the solvent liquid in the syringe 14 is injected into the vial 1, and shaken to dissolve the medicine in the vial 1 completely; keep the needle plug 7 -connecting tube 5-injection needle tube 6 access, the catheter joint 11 and the connecting tube 5 are in an open circuit state, use the syringe 14 to extract the medicine in the vial 1 into the syringe 14; then adjust the control knob of the three-way valve 10 to make the needle plug 7 (syringe 14)—connecting pipe 5—catheter joint 11 is in the passage, the injection needle 6 and the connecting pipe 5 are in an open circuit state, and then the medicine in the syringe 14 is pushed out to the conduit joint 11, and is introduced into the corresponding equipment by the conduit joint 11 or injected directly into the patient. In this embodiment, the control knob of the three-
参见图1-4,注射针管6侧壁设置有贯穿注射针管6管壁的通孔12,通孔12位于注射针管6上靠近针尖的位置,且通孔12与针尖之间的距离大于等于西林瓶1瓶盖的厚度。因大多数情况下尤其是西林瓶1内的药剂为粉剂时西林瓶1内处于负压状态,若注射针管6注入溶媒液体的量较少时,西林瓶1内仍处于负压状态,在后续采用注射器14抽取药物过程中会使得医务人员不易抽取西林瓶1内的药物,费时费力。本实施例在注射针管6的针尖刺穿西林瓶1瓶盖并逐渐伸入西林瓶1内腔,且通孔12还处于西林瓶1瓶盖外的时候,注射针管6的针尖部位与管壁的通孔12将西林瓶1内的气压与西林瓶1外的气压连通,使西林瓶1内的气压与西林瓶1外的气压平衡;然后继续刺入注射针管6,使通孔12位于西林瓶1内后推入溶媒液体,进行药物配置。后续的药物抽取过程中,药物抽出时的抽吸阻力小,不会出现药物抽吸困难的问题。1-4, the side wall of the
此外,现有技术中的注射针头在进行西林瓶1内的药物抽取时,为保证西林瓶1内的药物被完全抽出,一般是将注射器14朝上,使西林瓶1倒置,然后将注射针头的针尖逐渐向外拔,使针尖靠近西林瓶1瓶盖的内侧位置,然后抽吸西林瓶1内的药物;当西林瓶1内的药物抽吸至靠近西林瓶1瓶盖时,为保证西林瓶1内的液面没过针尖,需要一边抽吸一边向外拔注射针头。这个过程操作比较繁琐,稍有不慎就会直接把注射针头拔出,存在刺伤医务人员的风险;而且西林瓶1内的药物还没有完全抽出,需要反复将注射针头刺入西林瓶1内。本实施例中通过在注射针管6的管壁设置通孔12,套帽3与筒体2均采用透明材质制得,在西林瓶1推入筒体2内注射针管6刺入西林瓶1过程中,医务人员通过观察并调节通孔12的位置,使通孔12刚好位于西林瓶1内靠近西林瓶1瓶盖的位置,再进行溶媒液体的注入。需要抽出西林瓶1内的药物时,先将盖在筒体2上的套帽3朝下,此时西林瓶1的瓶盖朝下,直接抽取西林瓶1内的药物即可,此时西林瓶1内的药物可以通过通孔12抽取完全,即使是在刺入过程中需要调整通孔12的位置,也不容易产生将整个注射针管6拔出的问题。In addition, when the injection needle in the prior art is used to extract the medicine from the
注射针管6内腔中设置有可供介质由注射针管6内腔流向针尖方向的单向气阀,单向气阀位于通孔12与针尖之间。通过通孔12对西林瓶1内的药物进行抽取时,当西林瓶1内药物液面低于针尖的位置时,西林瓶1内的气体则会容易通过针尖处被抽出,使药物中混有气体,后续操作过程需要反复调整注射器14以排除气体;单向气阀的设置既可以保证注射针管6刺入西林瓶1过程中,由通孔12进入的气体经单向气阀进入针尖部分然后排入西林瓶1内,以平衡西林瓶1内的气压,减小后续药物抽出时的抽吸阻力;而且还能在抽吸过程中药物液面低于针尖时,西林瓶1内的气体不会通过针尖部分进入注射针管6内,不需要医务人员反复调整注射器14以排除气体,省时省力。The inner cavity of the
参见图1-5,本实施例中的单向气阀为鸭嘴阀13,鸭嘴阀13包括可固定于注射针管6内腔的内管,内管由弹性材料制得,内管的直径等于注射针管6的内径,内管靠近针尖的端口边缘呈接触闭合的V型结构,V型结构的尖部朝向注射针管6的针尖方向。当注射针管6刺入西林瓶1且通孔12位于西林瓶1外时,外界的气体经通孔12进入注射针管6,然后进入鸭嘴阀13的内管中,将V型结构尖部接触闭合部位撑开,气体则由V型结构尖部进入针尖一侧,最后进入西林瓶1内,实现瓶内与瓶外的气压平衡。在西林瓶1倒置药物抽吸过程中,外界气体或液体在V型结构的尖部产生向下的推力作用,V型结构的接触闭合部位接触更紧密,使液体或者气体不能经过注射针管6的针尖进入注射针管6内,特别是保证了西林瓶1内的液面低于针尖部分时,西林瓶1内的气体不会被抽入注射器14内。1-5, the one-way air valve in this embodiment is a
需要说明的是,本实施例中的套帽3、注射针管6、三通阀10、针栓7、导管接头11等与药物或溶媒液体接触的物质均为一次性使用,可以防止交叉污染;带有凸缘4以及卡口片9的筒体2在整个操作过程中可实现与药物无接触,因此筒体2可以在没有被药物污染的条件下重复使用,节约资源,降低消耗,节省成本。It should be noted that, in this embodiment, the
此外,套帽3与筒体2的材质可以是玻璃或其他透明可以成型且无污染性的材质,注射针管6可以由塑料或金属制得。本实施例中的套帽3与筒体2均由透明的聚碳酸酯制得,注射针管6的材质为塑料,成本低,易于加工成型。In addition, the material of the
实施例2Example 2
参见图1-5,一种用于抗肿瘤药物的密闭式配制装置的使用方法,包括如下步骤:Referring to Figures 1-5, a method for using a closed-type compounding device for antineoplastic drugs, comprising the following steps:
S1、将带有瓶盖的西林瓶1端头由筒体2不带套帽3的敞口端插入筒体2内,推挤西林瓶1使筒体2内凸缘4卡住西林瓶1的颈部,并使套帽3内侧的注射针管6的尖部逐渐插入西林瓶1内腔中,并保持通孔12位于西林瓶1外,进行西林瓶1内气压的平衡;S1. Insert the end of the
S2、逐渐将注射针管6刺入西林瓶1中至通孔12位于西林瓶1内腔且靠近瓶盖内壁的位置,将抽取好溶媒液体的注射器14乳头插入针栓7内,推挤注射器14的活塞推杆使注射器14内的溶媒液体依次经连接管内腔、注射针管6进入西林瓶1内;S2, gradually pierce the
S3、手持注射器14、套帽3及筒体2并对西林瓶1内的药物进行摇匀,使筒体2内西林瓶1中的药物充分混合溶解,然后将筒体2倒置使西林瓶1的瓶盖朝下,拉动注射器14的活塞推杆,将西林瓶1内混合好的药物抽至注射器14内。在防止混药过程中药物飞溅的基础上,通过在注射针管6上设置通孔12,实现西林瓶1内气压的平衡,规避了注入溶媒过程中气压阻力较大的问题。S3, hold the
连接管中部通过三通阀10连接有导管接头11,在西林瓶1内混合好的药物抽至注射器14后,调节三通阀10使注射器14—连接管—导管接头11处于通路状态,再通过推动注射器14的活塞推杆将注射器14内已经配置好的药物经导管接头11转移至输液袋、输液瓶或者其他药物中转输送设备中,使化疗药物整个配置过程药物都处于密封环境。The middle part of the connecting pipe is connected with the catheter joint 11 through the three-
本实施例中的其他部分与实施例1相同,这里不再赘述。Other parts in this embodiment are the same as those in
如上即为本发明的实施例。上述实施例以及实施例中的具体参数仅是为了清楚表述发明验证过程,并非用以限制本发明的专利保护范围,本发明的专利保护范围仍然以其权利要求书为准,凡是运用本发明的说明书及附图内容所作的等同结构变化,同理均应包含在本发明的保护范围内。The above is an embodiment of the present invention. The above examples and the specific parameters in the examples are only to clearly describe the invention verification process, not to limit the scope of patent protection of the present invention. The scope of patent protection of the present invention is still based on the claims. Equivalent structural changes made in the contents of the description and drawings shall be included within the protection scope of the present invention.
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