WO2022188187A1 - 颈静脉给药插管 - Google Patents

颈静脉给药插管 Download PDF

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Publication number
WO2022188187A1
WO2022188187A1 PCT/CN2021/080655 CN2021080655W WO2022188187A1 WO 2022188187 A1 WO2022188187 A1 WO 2022188187A1 CN 2021080655 W CN2021080655 W CN 2021080655W WO 2022188187 A1 WO2022188187 A1 WO 2022188187A1
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Prior art keywords
gasket
jugular vein
hose
silicone tube
drug delivery
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PCT/CN2021/080655
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English (en)
French (fr)
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刘昱
徐星
范润月
阮焰倩
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宁波大学
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Publication of WO2022188187A1 publication Critical patent/WO2022188187A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61D—VETERINARY INSTRUMENTS, IMPLEMENTS, TOOLS, OR METHODS
    • A61D7/00—Devices or methods for introducing solid, liquid, or gaseous remedies or other materials into or onto the bodies of animals
    • 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
    • A61M25/00—Catheters; Hollow probes

Definitions

  • the utility model relates to an intravenous drug delivery device, in particular to a drug delivery cannula, which belongs to the technical field of medical devices.
  • Intravenous self-administration is one of the most widely used animal models for drug addiction research. In this model, animals can obtain drugs entering the body from the jugular vein by actively pressing the plate or nasal touch, and complete the effective intravenous self-administration behavior. Meanwhile, intravenous self-administration experiments generally lasted for several weeks or even months. Therefore, the success rate, stability and availability of intravenous cannulation surgery are more important in whether animals can maintain effective self-administration behavior for a long time. Intravenous cannulation is the experimental basis to ensure the completion of intravenous self-administration, and good and durable intravenous access is an important condition to ensure long-term effective drug administration in animals.
  • Intravenous self-administration experiments generally last for several weeks or even months, so the success rate, stability and availability of external intravenous cannulation surgery are more important.
  • the jugular vein cannulation is the experimental basis to ensure the completion of intravenous self-administration, and a good and durable venous access is an important condition to ensure long-term effective drug administration in animals.
  • Intravenous self-administration can be achieved in a variety of animals, including rats, mice, primates, cats, dogs, etc. Rats are a commonly used experimental animal for physiology, pharmacology, and pharmacokinetic research. At the same time, the moderate size of rats and the quicker postoperative recovery also make them the most commonly used animals for intravenous self-administration experiments.
  • the basic accessories required for jugular vein intubation surgery are catheters, which are implanted in the body mainly including the back or head.
  • the back intubation surgery is divided into two types: back and no back.
  • the intubation technology using the back piece please refer to the Chinese utility model patent "protection device for the extracorporeal part of rat femoral artery intubation" with patent number ZL200520013524.0.
  • it has disadvantages such as troublesome operation, complicated equipment, and large trauma to rats.
  • the silicone tube since the silicone tube is a foreign body, it will gradually scab in front of the opening of the flat end, which will lead to the outflow of the given drug or heparin, which will lead to leakage;
  • the third is that after the surgical ligation, it will gradually loosen. In this way, when the drug is administered, due to the directional force, the silicone tube will gradually retreat, and finally the socket will pop out, which will affect the drug delivery process;
  • the validity period of use is short, the intubation will generally be blocked and leaked for 4-6 days, and the maintenance period of self-administration is 14 days, so the intubation on one side should be maintained for at least 7-10 days. .
  • the applicant has disclosed an improved cannula, see the Chinese utility model patent "Intravenous Self-Administration Cannula" (authorized announcement number CN206659964U) whose patent number is ZL201621462553.X.
  • the above problems are solved in the above, but the existing intubation is generally aimed at rats, but not many mice. Due to the difference in body shape between mice and rats, the stability of the intubation is required to be higher. At the same time, the incision should not be too many, which will affect the postoperative recovery and increase the risk of failure.
  • the technical problem to be solved by the present utility model is to provide a jugular vein administration cannula suitable for mice and with a high success rate in view of the above-mentioned technical status.
  • a jugular vein drug delivery cannula comprising:
  • Rigid conduit in the shape of an L-shaped bend, with a vertical part and a horizontal part;
  • One end of the hose is tightly sleeved on the aforementioned horizontal part, the other end is the insertion end and the end is formed with a flat end opening,
  • the drug administration cannula also includes a silicone tube, the inner diameter of the silicone tube is adapted to the outer diameter of the hose, the silicone tube is tightly sleeved on the outside of the joint part of the hose and the rigid catheter, and one end of the silicone tube is covered. On the outer circumference of the rigid conduit, the other end covers the outer circumference of the hose.
  • the insertion end of the hose is provided with a side opening behind the flat end opening, the side opening is inclined from the rear to the front and the opening is arranged forward.
  • the bonding block and the gasket are integrally formed, and the gasket has a sheet-shaped plastic part therein.
  • the vertical part of the rigid conduit is provided with a connecting head with an external thread on the outer surface, and the connecting head is integrally bonded with the gasket through an adhesive block.
  • the flexible tube is sequentially provided with a silicone ball that can be implanted into the blood vessel after the lateral opening.
  • the hoses are located in two lateral openings and are located on the same section and are arranged in a staggered manner.
  • the edge of the gasket is gradually raised toward the middle. Make the gasket more stable and reliable after placement.
  • the utility model has the advantages that: the silicone tube can improve the connection strength between the hose and the hard conduit, ensure that the hose will not easily fall out, and at the same time help to improve the load-bearing capacity of the gasket part, so that the insertion It can remain stable during pipe work.
  • FIG. 1 is a schematic structural diagram of Embodiment 1.
  • FIG. 1 is a schematic structural diagram of Embodiment 1.
  • FIG. 2 is a perspective cross-sectional view of the embodiment.
  • FIG. 3 is an exploded view of Embodiment 1.
  • FIG. 3 is an exploded view of Embodiment 1.
  • FIG. 4 is a schematic structural diagram of Embodiment 2.
  • FIG. 4 is a schematic structural diagram of Embodiment 2.
  • the jugular vein administration cannula in this embodiment includes a gasket 4, a rigid catheter 1, a connector 2, an adhesive block 3, a hose 6, Silicone tube 5 and silicone ball 7.
  • the rigid conduit 1 is bent in an L shape and has a vertical portion 11 and a horizontal portion 12; the bonding block 3 bonds the connector and the rigid conduit 1 to the end face of the gasket 4, while the vertical portion 11 is perpendicular to the pad Slice 4 set.
  • One end of the hose 6 is tightly sleeved on the horizontal part 12 , and the other end is an insertion end with a flat end opening 61 formed at the end.
  • the insertion end of the hose 6 is provided with a side opening 62 behind the flat end opening 61 . It is inclined from the rear to the front and the opening is set forward.
  • the functions of the lateral openings 62 are provided as follows:
  • the side openings can serve as backup openings for the blunt openings 61 , which can become blocked by blood in the blunt openings 61 .
  • the gasket is located at the bottom of the bottom bonding block 3 .
  • the bonding block 3 and the gasket 4 are integrally formed, and the gasket 4 has a sheet-shaped plastic part 41 therein.
  • the edge of the gasket 4 is gradually raised toward the middle, so as to improve the stability of the cannula.
  • the inner diameter of the silicone tube 5 is adapted to the outer diameter of the hose 6, the silicone tube 5 is tightly sleeved on the outside of the joint part of the hose 6 and the rigid conduit 1, one end of the silicone tube 5 covers the outer periphery of the rigid conduit 1, and the other end is Cover the outer circumference of the hose 6 .
  • the silicone tube 5 can improve the connection strength between the hose and the hard catheter, ensure that the hose will not easily fall out, and at the same time help to improve the load-bearing capacity of the gasket part, so that the intubation operation can be kept stable.
  • the outer surface of the connecting head 3 has external threads, and the connecting head 3 is bonded to the gasket 4 as a whole through the bonding block 3 .
  • the connector 3 is equipped with a detachable cap, the cap can seal the rigid catheter 1, and the cap is removed during intubation.
  • the silicone ball 7 is arranged at the insertion end of the flexible tube 6 and is located behind the lateral opening 62.
  • the silicone ball 7 can be implanted in the blood vessel to improve the stability of the cannula.
  • the rigid conduit 1 is made of stainless steel elbow, and the rigid conduit is provided with a connector.
  • the lengths of the two ends of the rigid conduit are respectively 5mm straight pipe and 11mm 90° elbow;
  • the hose 6 is made of an inner diameter of 0.03mm ⁇ outer diameter of 0.64mm.
  • the silicone tube is made of silicone, and the silicone tube 5 is a tube with an inner diameter of 0.64mm ⁇ an outer diameter of 1.19mm.
  • the plastic sheet 41 is a circular plastic gasket made of polypropylene with a diameter of about 1.2 cm.
  • Catheter making process Cut the hose 6cm and the silicone tube 1.5cm. Put the cut hose and silicone tube into a glass vessel filled with xylene solution, so that they are completely immersed in the xylene solution for about 3 minutes, so that the hose and silicone tube are completely soaked. After softening, first put one end of the hose slowly into the horizontal end of the curved rigid conduit, and then put the silicone tube over the hose. After natural drying in a fume hood, rinse with normal saline to check for patency. After lubricating the mold with cooking oil, the rigid conduit, hose and silicone tube assembly is placed in the mold.
  • tray powder and tray water to a suitable viscosity
  • tray material dental tray powder and tray water
  • plastic sheet on the mold hole .
  • gasket in a fume hood for at least 45 minutes to allow it to solidify naturally, and the best effect can be achieved overnight. Subsequently, the finished component is removed from the mold.
  • Embodiment 2 there are two lateral openings 62 in this embodiment, which are located on the same section and are arranged staggered. Two lateral openings make scabs and blockages less likely. Being on the same section can better stabilize the force of the hose, but there is an increased disadvantage of wounding.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

一种颈静脉给药插管，包括垫片（4）、硬质导管（1）、粘接块（3）、软管（6）及硅胶管（5），硬质导管（1）呈L形弯折状，具有竖直部（11）和水平部（12）；粘接块（3）将硬质导管（1）粘结于垫片（4）的端面上，而竖直部（11）则垂直垫片（4）设置；软管（6）一端密封地套接于水平部（12），另一端则为插入端并端部形成平端开口，其特征在于硅胶管（5）的内径与软管（6）的外径适配，硅胶管（5）密封地套接于软管（6）与硬质导管（1）结合部位外侧，硅胶管（5）一端覆盖于硬质导管（1）外周，另一端覆盖于软管（6）外周。硅胶管（5）可以提高软管（6）与硬质导管（1）的连接强度，确保软管（6）不会轻易掉出来，同时有利于提高垫片（4）部分的承重性，使得插管作业时能保持稳定。

Description

颈静脉给药插管 技术领域
本实用新型涉及一种静脉给药器械，尤其涉及一种给药插管，属于医用器械技术领域。
背景技术
静脉自身给药是药物成瘾研究中应用最广泛的动物模型之一。在该模型中，动物通过主动按板或鼻触行为，获得从颈静脉进入体内的药物，完成有效的静脉自身给药行为。同时，静脉自身给药实验一般历时为几周甚至几个月。因此，静脉插管手术的成功率、稳定性和可利用度在动物能否长期间保持有效自身给药行为中显得更为重要。静脉插管手术是保证静脉自身给药完成的实验基础，而良好和持久的静脉通路是保证动物进行长期有效给药的重要条件。静脉自身给药实验一般历时为几周甚至几个月，因此外静脉插管手术的成功率、稳定性和可利用度显得更为重要。颈静脉插管手术是保证静脉自身给药完成的实验基础,而良好和持久的静脉通路是保证动物进行长期有效给药的重要条件。
静脉自身给药可以在多种动物上实现，包括大鼠、小鼠、灵长类、猫、狗等，大鼠是进行生理学、药理学、药物代谢动力学研究时常用的一种实验动物。同时，大鼠体积适中和术后较快的恢复也使其成为静脉自身给药实验中最为常用的动物。
颈静脉插管手术所需的基本配件是导管，导管植入体内部分主要包括背部或头部。其中，背部插管手术又分为背件和无背件两种。采用背件的插管技术可以参考专利号为ZL200520013524.0的中国实用新型专利《大鼠股动脉插管体外部分的保护装置》。但其存在操作麻烦，所需设备复杂，对大鼠创伤较大等不足。
作为改进，本申请人于先前公开了一种改进的《静脉自身给药插管》(授权公告号CN 202036363 U)，见专利ZL 201120009256.0。虽然该专利公开的插管具有生产制造方便，材料易得，制造成本较低的优点，但存在如下不足：
其一，只有前端开口，给完药或者通完管，拔出给药管后，由于吸力的作用，会在另一开口端吸出一小段血液，这样反反复复，血管里的开口端会越来越窄，最后导致堵塞和漏液；
其二，由于硅胶管是异物，这样会导致平端开口前方逐渐结痂，从而导致所给药物或者肝素方向流出，这样就导致了漏液；
其三，是手术结扎后，逐渐会松开，这样给药时，由于方向作用力，会使硅胶管逐渐后退，最后弹出插口，影响给药进程；
其四，使用有效期较短，该插管一般维持4-6天就会出现堵塞、漏液的情况，而自身给药维持期为14天，所以一侧的插管至少要维持7-10天。
为此，申请人又公开了一种改进的插管，见专利号为ZL201621462553.X的中国实用新型专利《静脉自身给药插管》(授权公告号为CN206659964U)，该专利通过改进的结构基本上解决了上述问题，但现有的插管普遍针对大鼠来说的，针对小鼠的却不多，由于小鼠与大鼠在体形上有差异，对插管的稳定性要求更高，同时切口不能过多，会影响术后的恢复，从而提高失败风险。
发明内容
本实用新型所要解决的技术问题是针对上述的技术现状而提供一种适合小鼠的且成功率高的颈静脉给药插管。
本实用新型解决上述技术问题所采用的技术方案为：一种颈静脉给药插管，包括
垫片；
硬质导管，呈L形弯折状，具有竖直部和水平部；
粘接块，将前述的硬质导管粘结于垫片的端面上，而前述的竖直部则垂直垫片设置；以及
软管，一端密封地套接于前述水平部，另一端则为插入端并端部形成平端开口，
其特征在于该给药插管还包括硅胶管，该硅胶管的内径与软管的外径适配，该硅胶管密封地套接于软管与硬质导管结合部位外侧，该硅胶管一端覆盖于硬质导管外周，另一端覆盖于软管外周。
进一步，所述软管的插入端在平端开口后方开设有侧向开口，该侧向开口自后向前倾斜并开口朝前设置。
进一步，所述粘接块与垫片一体成型，并且，所述垫片内具有片状的塑料件。
进一步，所述硬质导管的竖直部上设有外表面具有外螺纹的连接头，该连接头通过粘接块与垫片粘接为一体。
进一步，所述软管位于侧向开口之后依次设有能植入血管中的硅胶球。
进一步，所述软管位于侧向开口为两个并位于同一截面上且错开布置。
进一步，所述垫片的边缘向中间逐步凸起。使得垫片安置后比较稳定可靠。
与现有技术相比，本实用新型的优点在于：硅胶管可以提高软管与硬质导管的连接强度，确保软管不会轻易掉出来，同时有利于提高垫片部分的承重性，使得插管作业时 能保持稳定。
附图说明
图1为实施例1结构示意图。
图2为实施例立体剖视图。
图3为实施例1分解图。
图4为实施例2结构示意图。
具体实施方式
以下结合附图实施例对本实用新型作进一步详细描述。
实施例1，如图1、图2和图3所示，本实施例中的颈静脉给药插管包括垫片4、硬质导管1、连接头2、粘接块3、软管6、硅胶管5及硅胶球7。
硬质导管1呈L形弯折状，具有竖直部11和水平部12；粘接块3将连接头和硬质导管1粘结于垫片4的端面上，而竖直部11垂直垫片4设置。
软管6一端密封地套接于水平部12，另一端则为插入端并端部形成平端开口61，软管6的插入端在平端开口61后方开设有侧向开口62，该侧向开口62自后向前倾斜并开口朝前设置。侧向开口62设置的作用如下：
首先，在给药和通管的时候，会排除掉侧向开口处的血液，这样不会结痂；
其次，给药的时候，由于药液冲侧向开口流出，会给软管一个力，这样管子会受到向前的分力，在该力的作用下，软管就不会向后移动；
再次，侧向开口可以作为平端开口61的备份开口，平端开口61的血液会使平端开口61堵塞。
垫片位于底部粘接块3的底部，本实施例中的粘接块3与垫片4一体成型，垫片4内具有片状的塑料件41。本实施例中的垫片4的边缘向中间逐步凸起，用以提高插管的稳定性。
硅胶管5的内径与软管6的外径适配，该硅胶管5密封地套接于软管6与硬质导管1结合部位外侧，硅胶管5一端覆盖于硬质导管1外周，另一端覆盖于软管6外周。硅胶管5可以提高软管与硬质导管的连接强度，确保软管不会轻易掉出来，同时有利于提高垫片部分的承重性，使得插管作业时能保持稳定。
连接头3外表面具有外螺纹，连接头3通过粘接块3与垫片4粘接为一体。连接头3配备脱卸式的帽盖，帽盖能将硬质导管1封住，插管时，取下帽盖。
硅胶球7设于软管6的插入端并位于侧向开口62之后，硅胶球7能植入血管中提 高插管的稳定性。
硬质导管1采用不锈钢弯管，硬质导管上设有连接头，硬质导管两端长度分别为5mm直管和11mm的90°弯管；软管6采用内径0.03mm×外径0.64mm的硅胶材质的软管，硅胶管5采用内径0.64mm×外径1.19mm的管子。
塑料片41采用直径1.2cm左右的聚丙烯材质的圆形塑料垫片。
导管制作过程：裁剪软管6cm和硅胶管1.5cm。将裁剪好的软管和硅胶管放入装有二甲苯溶液的玻璃器皿内，使它们完全浸泡在二甲苯溶液中3min左右，使软管和硅胶管完全浸软。软化后，先将软管一端缓慢套入弯曲的硬质导管的水平部一端，随后将硅胶管套在软管上。在通风橱中自然干燥后，用生理盐水冲洗，检验是否通畅。将模具用食用油润滑后，将硬质导管、软管和硅胶管的组合件置于模具内。将牙托粉和牙托水混合至适宜的粘稠程度，然后将牙托材料(牙托粉和牙托水)迅速灌注入模具孔中用以铸型，将塑料片快速放置到模具孔上。将垫片放置在通风橱内至少为45min以上，使其自然凝固，过夜可达到最佳效果。随后，将已制作完成的组件从模具中移出。
在距离软管底端0.7cm处，用医用硅橡胶粘结剂点一个直径为1.5mm的硅胶球，将其放置烘箱烘干即可。
如图4所示，实施例2，本实施例中的侧向开口62为两个并位于同一截面上且错开布置。两个侧向开口使得结痂和堵塞的可能性更小。位于同一截面上可以更好的稳定软管受力，但存在会伤口的增加不利因素。

Claims (7)

  1. 一种颈静脉给药插管，包括
    垫片(4)；
    硬质导管(1)，呈L形弯折状，具有竖直部(11)和水平部(12)；
    粘接块(3)，将前述硬质导管(1)粘结于垫片(4)的端面上，而前述的竖直部(11)则垂直垫片(4)设置；以及
    软管(6)，一端密封地套接于前述水平部(12)，另一端则为插入端并端部形成平端开口(61)，
    其特征在于该给药插管还包括硅胶管(5)，该硅胶管(5)的内径与软管(6)的外径适配，该硅胶管(5)密封地套接于软管(6)与硬质导管(1)结合部位外侧，该硅胶管(5)一端覆盖于硬质导管(1)外周，另一端覆盖于软管(6)外周。
  2. 根据权利要求1所述的颈静脉给药插管，其特征在于所述软管(6)的插入端在平端开口(61)后方开设有侧向开口(62)，该侧向开口(62)自后向前倾斜并开口朝前设置。
  3. 根据权利要求1所述的颈静脉给药插管，其特征在于所述粘接块(3)与垫片(4)一体成型，并且，所述垫片(4)内具有片状的塑料件(41)。
  4. 根据权利要求1所述的颈静脉给药插管，其特征在于所述硬质导管(1)的竖直部(11)上设有外表面具有外螺纹的连接头(3)，该连接头(3)通过粘接块(3)与垫片(4)粘接为一体。
  5. 根据权利要求1所述的颈静脉给药插管，其特征在于所述软管(6)位于侧向开口(62)之后依次设有能植入血管中的硅胶球(7)。
  6. 根据权利要求1所述的颈静脉给药插管，其特征在于所述软管(6)位于侧向开口(62)为两个并位于同一截面上且错开布置。
  7. 根据权利要求1所述的颈静脉给药插管，其特征在于所述垫片(4)的边缘向中间逐步凸起。
PCT/CN2021/080655 2021-03-10 2021-03-15 颈静脉给药插管 WO2022188187A1 (zh)

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CN218793515U (zh) * 2022-11-12 2023-04-07 中国科学院深圳先进技术研究院 一种颈静脉置管

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CN206404175U (zh) * 2016-11-14 2017-08-15 中国人民解放军第四军医大学 一种大鼠自身给药颈静脉置管的改良偶联装置
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