WO2017117997A1 - 静脉采血导管 - Google Patents

静脉采血导管 Download PDF

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Publication number
WO2017117997A1
WO2017117997A1 PCT/CN2016/092999 CN2016092999W WO2017117997A1 WO 2017117997 A1 WO2017117997 A1 WO 2017117997A1 CN 2016092999 W CN2016092999 W CN 2016092999W WO 2017117997 A1 WO2017117997 A1 WO 2017117997A1
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tube
blood collection
epitaxial
catheter
venous blood
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PCT/CN2016/092999
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English (en)
French (fr)
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万华印
张俊辉
朱晋辉
李伟达
樊鸿浩
邓乐君
万文悦
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广州市众为生物技术有限公司
广州市拜特淞医药科技有限公司
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Publication of WO2017117997A1 publication Critical patent/WO2017117997A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes

Definitions

  • the utility model relates to the field of medical instruments, in particular to a catheter for performing sterile blood sampling in an animal vein.
  • animal plasma or serum As raw materials, such as animal fibrin glue, immunoglobulin, etc.
  • the quality of animal plasma or serum affects the effectiveness and safety of biological products.
  • the method of collecting large amounts of blood for pigs, cattle, sheep and other animals is mainly the method of assassination and bloodletting. Such a method can only collect blood for preparing animals for slaughtering at one time, which is a waste of resources for plasma collection. At the same time, blood flows out of the wound, causing blood contamination by contact with the fur and body fluids.
  • Li Yong invented the method of “closed aseptically producing raw material animal serum with multi-bags” (Chinese Patent Application No. 200510096345.2), Lanzhou Veterinary Research Institute of Chinese Academy of Agricultural Sciences disclosed “a large-dose automatic blood collection device for experimental animals” (Chinese Patent Application No. 201420170911.4), these two blood collection devices enable the collection of multiple blood samples of animals in a closed system, greatly reducing the possibility of blood contamination.
  • both devices use the blood collection needle to directly collect blood in the animal, which takes a long time, and the blood collection needle is easily broken off by the animal, which causes multiple punctures to be taken.
  • the central venous catheter is a catheter placed in the blood vessel, which can be used for rapid infusion rehydration and blood sample collection.
  • the indwelling catheter can realize multiple living blood collection for large animals. Even if there is no need to anesthetize the animals such as pigs and sheep, the catheter can be used for large-scale blood collection to avoid the animal struggling and the blood collection needle is detached from the blood vessel.
  • the catheter-connected plasma collection machine or vacuum blood collection bag can achieve stable sterile plasma or whole blood collection.
  • Ordinary single-lumen catheters have thinner diameters or no larger side holes, which makes it difficult to increase the blood collection rate, and the continuous blood collection catheter is also susceptible to blockage; 2.
  • the central vein with a slightly larger diameter
  • the catheters are mainly double-cavity or multi-lumen catheters.
  • the main lumen of these catheters is not really large, and the secondary tube joints are even more obstructive;
  • the large-caliber single-cavity catheters are actually pig-tail porous conduits (drainage tubes), bent
  • the catheter opening is not suitable for placement in the blood vessel, and too many side holes are not conducive to the catheter; 3.
  • the softer tapered catheter opening is not conducive to the internal tube in the large animal body, and the catheter is easy to be as "pumping machine" during blood collection.
  • the pressure inside the blood vessel is vibrated; 4.
  • the smoothness of the inner wall of the transparent epitaxial tube is not as good as that of the inner wall of the tube, and the multiple closure control of the slider, blood cells and blood lipids are easily adhered to the epitaxial tube during blood collection, hindering Blood collection.
  • the technical problem to be solved by the utility model is to provide a venous blood sampling catheter with simple structure, simple operation, and high success rate of tube placement and blood collection speed.
  • a venous blood sampling catheter comprising a tube body, a connecting seat, an epitaxial tube, a sliding buckle and an epitaxial tube joint, the rear end of the tube body passing through the connecting seat and the extension tube One end is connected, and the other end of the epitaxial tube is connected with the epitaxial pipe joint; the side end of the pipe body of the pipe body is provided with two side holes communicating with the pipe body.
  • the diameter of the blood collection tube of the catheter determines the flow rate and flow rate (or blood pressure) of the blood;
  • the catheter is always impacted by blood flow, and the blood encounters a smooth nozzle, which is easy to adhere and gather.
  • the blood collection speed is lower than 25 ml/min, the fibrin sheath is easily formed, so that the blood collection speed is slowed down.
  • the utility model provides a side hole at the front end of the pipe body, and the side hole relatively increases the diameter of the blood drawing, thereby speeding up the blood collection speed and making the fibrin sheath difficult to form, and solving the problem that it is difficult to increase the blood collection speed or the difficulty of the tube.
  • the two side holes are respectively located on opposite side walls of the pipe body.
  • the fact that the holes on both sides are not on the same side of the tube reduces the possibility of the catheter being deflected to one side.
  • the aperture of the side hole is 1/3-2/3 of the diameter of the tube body, the holes on both sides are 3-8 mm apart, and the side hole near the nozzle is 5-10 mm from the rear of the nozzle. Controlling the distance between the holes on both sides and the size of the aperture can avoid the weakness of the side hole portion due to the softening of the side hole, and the excessive side hole will increase the difficulty of the tube.
  • the tube body is a straight single-lumen catheter, and the tube body has a diameter ranging from 1.40 to 2.70 mm.
  • a fine caliber is not conducive to blood collection, while a caliber is too large for intravenous catheterization.
  • the front end of the tube body is 4 mm thickened wear-resistant tapered nozzle, and the nozzle material is silica gel, polyvinyl chloride or polyurethane. Avoiding multiple cycles of use, the tube is contracted or the tube is trembled at high pumping rate due to softening of the nozzle.
  • the epitaxial tube is a thickened transparent tube whose inner wall smoothness is similar to the smoothness of the tube body.
  • the thickened transparent material can prevent the slider from leaving wrinkles when the tube is closed and closed on the epitaxial tube multiple times, thereby avoiding the increase of friction between the blood and the epitaxial wall.
  • the epitaxial pipe joint is provided with a sliding wire capable of connecting a medical three-way valve, and the catheter can be connected to the plasma collecting machine through the medical three-way valve.
  • the catheter After the catheter is placed in the vein of the animal, the epitaxial tube joint and the medical tee The valve is connected, and the three-way valve is respectively connected with the syringe containing the physiological saline and the consumable of the plasma collecting machine, and the plasma collecting machine is started to collect the plasma of the animal, and the physiological saline is supplemented by the three-way valve when the blood cells are returned.
  • the present invention provides a side hole at the front end of the tube body, and the side hole relatively increases the diameter of the blood drawing, thereby speeding up the blood collection speed and making the fibrin sheath difficult to form, and solving the problem that it is difficult to increase the blood collection speed or the difficulty of catheterization;
  • the holes on both sides are not on the same side of the tube body, which can reduce the possibility of the catheter being bent to one side;
  • control the distance between the two sides of the hole 5-8mm and the size of the hole can avoid the side hole part becomes soft and not force when the tube is inserted, too much side hole will increase the difficulty of the tube;
  • the front end of the pipe body 4mm is a thickened wear-resistant tapered pipe mouth
  • the pipe mouth material is silica gel, polyvinyl chloride or polyurethane, avoiding high frequency due to softening of the pipe after repeated recycling
  • the tube is contracted or the tube is trembled
  • the thickened transparent material of the epitaxial tube can prevent the slider from leaving wrinkles when the tube is closed and closed on the epitaxial tube, thereby avoiding the increase of the friction between the blood and the epitaxial wall.
  • Figure 1 is a schematic view of the structure of the present invention.
  • Figure 2 is a structural view of the three-way valve connected to the animal after being placed in the animal body.
  • a venous blood sampling catheter includes a tube body 1 , a connecting seat 5 , an epitaxial tube 7 , a slider 6 and an epitaxial tube joint 8 .
  • the rear end of the tube body 1 passes through the connecting seat 5 and the epitaxial tube 7 .
  • One end is connected, and the other end of the epitaxial tube 7 is connected to the epitaxial pipe joint 8.
  • the tube body 1 is a straight single-cavity catheter, and the tube body has a diameter ranging from 1.40 to 2.70 mm (including the existing catheter specification range of 18-12 Ga or 4-8 Fr), and the caliber is too thin to be conducive to blood collection, and the caliber is too thick. It is not suitable for venous catheterization.
  • 4mm of the front end of the pipe body 1 is a soft wear-resistant silicone, polyvinyl chloride or polyurethane (PU) material conical nozzle 2, the inner wall of the nozzle 2 is thickened, to avoid blood flow and wear the nozzle and retain the second Secondary blood collection is unfavorable.
  • the holes 3 and 4 on both sides are located at the symmetric ends of the side wall of the pipe body 1.
  • the diameters of the side holes 3 and 4 are 1/3-2/3 of the pipe body 1, and the holes 3 and 4 on both sides are 5-8 mm apart.
  • the side hole 3 of the front end is 5-10 mm from the rear of the nozzle 2.
  • the epitaxial tube 7 is a transparent soft material, the inner wall smoothness is similar to the tube body, and the epitaxial tube 7 is provided with a slider 6 for controlling the passage of the tube.
  • the epitaxial pipe joint 8 is provided with a sliding wire capable of connecting the medical three-way valve, and can be connected with the consumable of the single plasma collecting machine through the medical three-way valve.
  • the utility model has the advantages of simple structure and simple operation, and no anesthesia is required when placing the vein of the neck of the pig. After the tube is placed, the speed of plasma collection can be greatly increased, and the possibility of catheter clogging can be reduced; at the same time, increasing the dispersion velocity of the side hole can reduce the pain or injury of the animal.
  • partial modification of materials for epitaxial tubes and nozzles can ensure the smoothness of secondary blood collection after indwelling catheters, achieve multiple blood collection, and reduce the cost of animal blood collection.
  • Pig blood collection The pigs that were tested were born for 3-4 months and weighed about 70 kg. The epidemic was qualified. The pigs were individually subjected to blood collection by slaughter and blood collection and ordinary 14Ga double lumen catheter (total diameter 2.00 mm), 14Ga catheter of the present invention, and 12Ga catheter (2.70 mm) tube-type blood collection method of the present invention. Plasma collection, blood collection rate, protein content, and whether or not the bacteria were detected.
  • Slaughter and blood collection In the pig slaughterhouse, the pigs are inverted and bound and slaughtered on the production line. The body surface is not sterilized, and the knife directly penetrates into the heart of the pig. The blood flows directly from the wound, and is collected by the basin. After the whole blood is collected, the blood is obtained by anticoagulation and centrifugation.
  • Tube-type blood collection the pigs are fixed on the lifting bar on the back, and the relevant experimental personnel personally do the disinfection work, prepare the skin for the right front limbs of the pig, and disinfect with the iodine and alcohol, and touch the internal jugular vein on the right side of the pig.
  • the pig is punctured, expanded, and placed into a venous blood collection catheter.
  • the puncture and catheterization methods are the same as the existing central venous catheter catheterization method.
  • the 14Ga catheter of the present invention is inserted into the scale of the tube body 1 between 11-13cm, and the tube mouth 2 reaches the anterior vena cava of the pig; as shown in Fig.
  • the epitaxial tube joint 8 of the catheter and the medical three-way valve a port 1 are 'Connected;
  • three-way valve b port 2' is connected with the disposable apheresis separator line that has been installed in the plasma collection machine, and is connected with anticoagulant bag for blood collection and plasma separation by means of a single plasma collection machine;
  • the port c port 3' is connected to a syringe filled with physiological saline, and is used as a physiological saline solution when the blood cells are returned to the pig body.
  • the tube placement and blood collection methods of the conventional 14Ga double lumen catheter (total diameter 2.00 mm) and the 12 Ga catheter (2.70 mm) of the present invention are the same as those described above.
  • the table below compares the test results for blood collection in different ways (or catheters).
  • the total protein content in plasma should be ⁇ 45g / L;
  • **Separate transfer within the same system means that the catheter is connected to the plasmapheresis and the plasma is directly separated into the plasma bag.
  • the pig was lifted again to the lifting bar.
  • the relevant staff did the disinfection work, disassembled the plastic protective film and suture, disinfected the epitaxial pipe joint 8, and injected 3-10 ml of heparin saline (8u/8). Ml), the catheter was again connected to the plasma collection machine according to Example 1, and the amount was 400 ml.
  • the rate of secondary blood collection is the same as that of the first time.
  • the plasma is tested for protein content and bacteria count.
  • a venous blood sampling catheter includes a tube body 1 , a connecting seat 5 , an epitaxial tube 7 , a slider 6 and an epitaxial tube joint 8 .
  • the rear end of the tube body 1 passes through the connecting seat 5 and the epitaxial tube 7 .
  • One end is connected, and the other end of the epitaxial tube 7 is connected to the epitaxial pipe joint 8.
  • the tube body 1 is a straight single-lumen catheter, and the tube body has a diameter of 2.00 mm. The diameter of the tube is too thin to be good for blood collection, and the tube diameter is too thick for the venous tube.
  • the front end of the pipe body 1 is 4 mm of a soft wear-resistant silicone, polyvinyl chloride or polyurethane (PU) material, and the inner wall of the pipe 2 is thickened to avoid It is unfavorable to avoid blood flow and wear the tube mouth after indwelling.
  • the holes 3 and 4 on both sides are located at the symmetric ends of the side wall of the pipe body 1.
  • the apertures of the side holes 3 and 4 are 1/3 of the pipe body 1, the holes 3 and 4 on both sides are 5 mm apart, and the side holes 3 are near the front end. 5mm behind the nozzle 2.
  • the epitaxial tube 7 is a transparent soft material, the inner wall smoothness is similar to the tube body, and the epitaxial tube 7 is provided with a slider 6 for controlling the passage of the tube.
  • the epitaxial pipe joint 8 is provided with a sliding wire capable of connecting the medical three-way valve, and can be connected with the consumable of the single plasma collecting machine through the medical three-way valve.
  • the utility model has the advantages of simple structure and simple operation, and no anesthesia is required when placing the vein of the neck of the pig. After the tube is placed, the speed of plasma collection can be greatly increased, and the possibility of catheter clogging can be reduced; at the same time, increasing the dispersion velocity of the side hole can reduce the pain or injury of the animal.
  • partial modification of materials for epitaxial tubes and nozzles can ensure the smoothness of secondary blood collection after indwelling catheters, achieve multiple blood collection, and reduce the cost of animal blood collection.
  • the blood collection effect of this embodiment is similar to that of the first embodiment.
  • a venous blood sampling catheter includes a tube body 1 , a connecting seat 5 , an epitaxial tube 7 , a slider 6 and an epitaxial tube joint 8 .
  • the rear end of the tube body 1 passes through the connecting seat 5 and the epitaxial tube 7 .
  • One end is connected, and the other end of the epitaxial tube 7 is connected to the epitaxial pipe joint 8.
  • the tube body 1 is a straight single-lumen catheter, and the tube body has a diameter of 2.70 mm. The diameter of the tube is too thin to be good for blood collection, and the tube diameter is too thick for the tube.
  • 4mm of the front end of the pipe body 1 is a soft wear-resistant silicone, polyvinyl chloride or polyurethane (PU) material conical nozzle 2, the inner wall of the nozzle 2 is thickened, to avoid blood flow and wear the nozzle and retain the second Secondary blood collection is unfavorable.
  • the holes 3 and 4 on both sides are located at the symmetric ends of the side wall of the pipe body 1.
  • the hole sizes of the side holes 3 and 4 are 1/3 of the pipe body 1, the holes 3 and 4 on both sides are 6 mm apart, and the side holes 3 are near the front end. 8mm behind the nozzle 2.
  • the epitaxial tube 7 is a transparent soft material, the inner wall smoothness is similar to the tube body, and the epitaxial tube 7 is provided with a slider 6 for controlling the passage of the tube.
  • the epitaxial pipe joint 8 is provided with a sliding wire capable of connecting the medical three-way valve, and can be connected with the consumable of the single plasma collecting machine through the medical three-way valve.
  • the utility model has the advantages of simple structure and simple operation, and no anesthesia is required when placing the vein of the neck of the pig. After the tube is placed, the speed of plasma collection can be greatly increased, and the possibility of catheter clogging can be reduced; at the same time, increasing the dispersion velocity of the side hole can reduce the pain or injury of the animal.
  • a venous blood sampling catheter includes a tube body 1 , a connecting seat 5 , an epitaxial tube 7 , a slider 6 and an epitaxial tube joint 8 .
  • the rear end of the tube body 1 passes through the connecting seat 5 and the epitaxial tube 7 .
  • One end is connected, and the other end of the epitaxial tube 7 is connected to the epitaxial pipe joint 8.
  • the tube body 1 is a straight single-lumen catheter, and the tube body has a diameter of 2.70 mm. The diameter of the tube is too thin to be good for blood collection, and the tube diameter is too thick for the tube.
  • the holes 3 and 4 on both sides are located at the symmetric ends of the side wall of the pipe body 1.
  • the hole sizes of the side holes 3 and 4 are 2/3 of the pipe body 1, the holes 3 and 4 on both sides are 8 mm apart, and the distance of the side holes 3 near the front end 10mm behind the nozzle 2.
  • the epitaxial tube 7 is a transparent soft material, the inner wall smoothness is similar to the tube body, and the epitaxial tube 7 is provided with a slider 6 for controlling the passage of the tube.
  • the epitaxial pipe joint 8 is provided with a sliding wire capable of connecting the medical three-way valve, and can be connected with the consumable of the single plasma collecting machine through the medical three-way valve.
  • the utility model has the advantages of simple structure and simple operation, and no anesthesia is required when placing the vein of the neck of the pig. After the tube is placed, the speed of plasma collection can be greatly increased, and the possibility of catheter clogging can be reduced; at the same time, increasing the dispersion velocity of the side hole can reduce the pain or injury of the animal.

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Abstract

一种静脉采血导管，包括管体（1）、连接座（5）、外延管（7）、滑扣（6）和外延管接头（8），所述管体（1）的后端通过连接座（5）与外延管（7）一端连接，外延管（7）另一端与外延管接头（8）连接；所述管体（1）的前端管口侧面设有与管体相通的两个侧孔（3，4）。在管体（1）的前端设置侧孔（3，4），侧孔（3，4）相对增加了抽血的口径，从而加快采血速度并使纤维蛋白鞘不易形成，解决了难以提高采血速度或置管困难的问题。

Description

静脉采血导管 技术领域
本实用新型涉及医疗器械领域，尤其涉及一种在动物静脉进行无菌采血的导管。
背景技术
市场上有很多生物制品和科学研究的试剂需要用动物血浆或血清作为原辅材料，如动物纤维蛋白胶、免疫球蛋白等，动物血浆或血清的质量影响着生物制品的有效性和安全性。目前对猪、牛、羊等动物大量采血的方法主要为刺杀放血法，此类方法只能一次性对准备屠杀动物进行采血，对血浆采集来说是一种资源浪费。同时，血液从伤口流出，接触皮毛和体液造成血液的污染。
鉴于此，李勇发明了“用多联袋全封闭无菌生产原料动物血清的方法”(中国专利申请号200510096345.2)，中国农业科学院兰州兽医研究所公开了“一种实验动物大剂量自动采血装置”(中国专利申请号201420170911.4)，这两种采血装置实现了能在封闭系统中对动物进行多次血液的采集，极大程度上减少了血液污染的可能。但这两种装置均以采血针的方式直接在动物体内采血，需要时间较长，并且采血针容易被动物挣脱而造成需要多次穿刺采血。
中心静脉导管是一种置入血管内的导管，可用于快速输液补液和采集血样等，留置导管能实现对大型动物进行多次活体采血。对猪羊等动物置管时甚至无须麻醉，导管用于大量采血能避免动物挣扎而采血针脱离血管的情况，导管连接血浆采集机或真空采血袋能实现稳定地无菌血浆或全血采集。目前市面上中心静脉导管虽种类繁多，然而仍没有专门设计或适合用于人或动物大量血液采集的单腔导管。其不利于采血的主要原因在于：1、普通的单腔导管管径较细或没有较大的侧孔，使得采血速度难以提高，持续采血导管也容易受堵；2、口径稍大的中心静脉导管则主要为双腔或多腔导管，这些导管的主管管腔实际并不大，而副管接头更是成为妨碍；口径大的单腔导管则实际为猪尾巴多孔导管(引流管)，弯曲的导管口不适合置入血管，侧孔过多也不利于置管；3、较细软的锥形导管口不利于在大型动物体内置管，且在采血时导管容易如“抽水机”般因负压在血管内震动；4、透明的外延管其内壁光滑度不如管体内壁，加上滑扣的多次通闭控制，采血时血细胞和血脂等容易粘附于外延管上，妨碍 采血。
发明内容
本实用新型所要解决的技术问题是提供一种静脉采血导管，结构简单，操作简便，能提高置管成功率和采血速度。
为解决上述技术问题，本实用新型的技术方案是：一种静脉采血导管，包括管体、连接座、外延管、滑扣和外延管接头，所述管体的后端通过连接座与外延管一端连接，外延管另一端与外延管接头连接；所述管体的前端管口侧面设有与管体相通的两个侧孔。大量研究以及生猪采血的实践中发现，使用市面上传统的中心静脉难以提高采血速度或置管困难的原因在于：一方面是导管的采血管径大小决定血液的流量与流速(或血压)；另一方面是采血时导管时刻受到血流冲击，血液遇到不光滑的管口易粘附聚集，在采血速度低于25ml/min时易形成纤维蛋白鞘，使采血速度更为减慢。本实用新型在管体的前端设置侧孔，侧孔相对增加了抽血的口径，从而加快采血速度并使纤维蛋白鞘不易形成，解决了难以提高采血速度或置管困难的问题。
作为改进，两所述侧孔分别位于管体相对的两侧壁上。两侧孔不在管体的同一侧能减少导管偏向单侧弯曲的可能。
作为改进，所述侧孔的孔径为管体口径的1/3-2/3大小，两侧孔相距3-8mm，靠近管口的侧孔距离所述的管口后方5-10mm。控制两侧孔距离以及孔径大小能避免插管时因有侧孔部位变软而不受力，侧孔过多也会增加置管的难度。
作为改进，所述的管体为直型单腔导管，所述的管体口径范围为1.40-2.70mm。口径过细不利于采血，而口径过粗则不适合静脉置管。
作为改进，所述管体前端4mm为增厚的耐磨性锥形管口，所述管口材料为硅胶、聚氯乙烯或聚氨基甲酸酯。避免多次循环利用后由于管口变软而导致高泵速采血时管口收缩堵塞或管体打颤。
作为改进，所述外延管为增厚的透明管，其内壁光滑度与所述管体光滑度相近。增厚的透明材料能避免所述的滑扣在外延管上多次控制导管通闭时留下褶皱，从而避免增加血液与外延管壁的摩擦。
作为改进，所述外延管接头上设有能连接医用三通阀的滑丝，导管能通过医用三通阀与血浆采集机连接。导管在动物的静脉置管后，所述的外延管接头与医用三通 阀连接，三通阀再分别与装有生理盐水的注射器以及血浆采集机的耗材连接，启动血浆采集机对动物进行血浆采集，并在回输血细胞时通过三通阀补充生理盐水。
本实用新型与现有技术相比所带来的有益效果是：
1、本发明在管体的前端设置侧孔，侧孔相对增加了抽血的口径，从而加快采血速度并使纤维蛋白鞘不易形成，解决了难以提高采血速度或置管困难的问题；
2、两侧孔不在管体的同一侧能减少导管偏向单侧弯曲的可能；
3、控制两侧孔距离5-8mm以及孔径大小能避免插管时因有侧孔部位变软而不受力，侧孔过多也会增加置管的难度；
4、管体前端4mm为增厚的耐磨性锥形管口，所述管口材料为硅胶、聚氯乙烯或聚氨基甲酸酯，避免多次循环利用后由于管口变软而导致高泵速采血时管口收缩堵塞或管体打颤；
5、外延管增厚的透明材料能避免所述的滑扣在外延管上多次控制导管通闭时留下褶皱，从而避免增加血液与外延管壁的摩擦。
附图说明
图1为本实用新型结构示意图。
图2为本实用新型置入动物体内后，与之连接的三通阀结构图。
具体实施方式
下面结合说明书附图对本实用新型作进一步说明。
实施例1
如图1所示，一种静脉采血导管，包括管体1、连接座5、外延管7、滑扣6和外延管接头8，所述管体1的后端通过连接座5与外延管7一端连接，外延管7另一端与外延管接头8连接。所述管体1为直型单腔导管，所述管体口径范围为1.40-2.70mm(包括了现有导管规格范围18-12Ga或4-8Fr)，口径过细不利于采血，而口径过粗则不适合静脉置管。管体1前端4mm为软质耐磨性硅胶、聚氯乙烯或聚氨基甲酸酯(PU)材料的锥形管口2，管口2内壁增厚，避免血流磨损管口而留置后二次采血不利。两侧孔3、4位于管体1侧壁对称的两端，侧孔3、4的孔径大小为管体1的1/3-2/3，两侧孔3、4相距5-8mm，近前端的侧孔3距离管口2后方5-10mm。 所述外延管7为透明软质材料，内壁光滑度与所述的管体相近，外延管7上设有控制导管通闭的滑扣6。外延管接头8上设有能连接医用三通阀的滑丝，通过医用三通阀导管能与单采血浆机的耗材连接。本实用新型结构简单、操作简便，置入猪颈部静脉时无须麻醉，置管后能大大增加血浆采集的速度，减少导管堵塞的可能；同时，增加侧孔分散流速能减轻动物的疼痛或伤害，符合动物伦理学标准；对外延管和管口等进行材质的部分改造能保证留置导管后二次采血的顺畅度，实现多次采血，降低动物采血的成本。
猪采血：进行试验的生猪生长期为3-4个月，体重约为70kg，防疫合格。分别用屠宰采血和普通14Ga双腔导管(总管径2.00mm)、本发明14Ga导管以及本发明12Ga导管(2.70mm)置管式采血方法对分别生猪进行采血。对血浆采集量、采血速度、蛋白含量和是否染菌进行检测。
屠宰采血：在生猪屠宰场中，生猪倒立绑定后在生产流水线上进行屠杀。体表不经消毒，用刀直接刺入猪心脏部位，血液直接从伤口流出，用盆收集，全血收集后经过抗凝和离心处理得到血浆。
置管式采血：将生猪仰卧固定在抬杠上，相关实验人员个人做好消毒工作，对猪右前肢凹陷窝区域进行备皮，并先后用碘酊、酒精消毒，摸出生猪右侧的颈内静脉或颈外静脉脉搏后，对猪进行穿刺，扩皮，置入静脉采血导管，其中的穿刺、置管方法同现有的中心静脉导管置管方法。本发明14Ga导管插入至管体1上刻度11-13cm之间，管口2便到达猪的前腔静脉内；如图2所示，接着导管的外延管接头8与医用三通阀a口1＇连接；三通阀b口2＇与已安装在单采血浆机的一次性单采血浆分离器管路连接，并接上抗凝剂袋，借助单采血浆机进行采血及血浆分离；三通阀c口3＇与装有生理盐水的注射器连接，用作回输血细胞到猪体时补充生理盐水。普通14Ga双腔导管(总管径2.00mm)和本发明12Ga导管(2.70mm)的置管、采血方法与上述过程相同。下表为不同方式(或导管)采血的检验结果比较。
Figure PCTCN2016092999-appb-000001
Figure PCTCN2016092999-appb-000002
备注：*根据欧洲药典要求是：血浆中的总蛋白含量应≥45g/L；
**同一系统内分离转移表示：导管连接单采血浆机后直接分离出血浆至血浆袋中。
留管后对猪的二次采血：首次血浆采集完成后，在三通阀c口3＇脉冲式注射3-5ml低浓度肝素生理盐水(100u/ml)，关闭外延管5上的滑扣6，拆卸外延管接头8上的医用三通阀a口1＇，用酒精棉球消毒外延管接头8，并盖上肝素帽。接着用塑料保护膜包住外延管接头8，再用缝合线在连接座5上将采血静脉导管呈“U”型缝合固定于猪表皮上，留置静脉采血导管，放养。五天后，把该生猪再次抬上抬杠，实验前相关工作人员做好消毒工作，拆卸塑料保护膜和缝合线，消毒外延管接头8，外延管接头8处注射3-10ml肝素生理盐水(100u/ml)，按照实施例1将导管再次与血浆采集机连接，采集量为400ml。二次采血的速度与首次采速度一样，血浆进行蛋白质含量检测和细菌数检查，均检验合格。
以上说明对本实用新型而言只是说明性的，而非限制性的，本领域一般技术人员，在不脱离本实用新型权利要求所限定的精神和范围的情况下，可做出许多修改、变化或等效，但都将落入本实用新型的保护范围之内。
实施例2
如图1所示，一种静脉采血导管，包括管体1、连接座5、外延管7、滑扣6和外延管接头8，所述管体1的后端通过连接座5与外延管7一端连接，外延管7另一端与外延管接头8连接。所述管体1为直型单腔导管，所述管体口径范围为2.00mm，口径过细不利于采血，而口径过粗则不适合静脉置管。管体1前端4mm为软质耐磨性硅胶、聚氯乙烯或聚氨基甲酸酯(PU)材料的锥形管口2，管口2内壁增厚，避 免血流磨损管口而留置后二次采血不利。两侧孔3、4位于管体1侧壁对称的两端，侧孔3、4的孔径大小为管体1的1/3，两侧孔3、4相距5mm，近前端的侧孔3距离管口2后方5mm。所述外延管7为透明软质材料，内壁光滑度与所述的管体相近，外延管7上设有控制导管通闭的滑扣6。外延管接头8上设有能连接医用三通阀的滑丝，通过医用三通阀导管能与单采血浆机的耗材连接。本实用新型结构简单、操作简便，置入猪颈部静脉时无须麻醉，置管后能大大增加血浆采集的速度，减少导管堵塞的可能；同时，增加侧孔分散流速能减轻动物的疼痛或伤害，符合动物伦理学标准；对外延管和管口等进行材质的部分改造能保证留置导管后二次采血的顺畅度，实现多次采血，降低动物采血的成本。本实施例的采血效果与实施例1类似。
实施例3
如图1所示，一种静脉采血导管，包括管体1、连接座5、外延管7、滑扣6和外延管接头8，所述管体1的后端通过连接座5与外延管7一端连接，外延管7另一端与外延管接头8连接。所述管体1为直型单腔导管，所述管体口径范围为2.70mm，口径过细不利于采血，而口径过粗则不适合静脉置管。管体1前端4mm为软质耐磨性硅胶、聚氯乙烯或聚氨基甲酸酯(PU)材料的锥形管口2，管口2内壁增厚，避免血流磨损管口而留置后二次采血不利。两侧孔3、4位于管体1侧壁对称的两端，侧孔3、4的孔径大小为管体1的1/3，两侧孔3、4相距6mm，近前端的侧孔3距离管口2后方8mm。所述外延管7为透明软质材料，内壁光滑度与所述的管体相近，外延管7上设有控制导管通闭的滑扣6。外延管接头8上设有能连接医用三通阀的滑丝，通过医用三通阀导管能与单采血浆机的耗材连接。本实用新型结构简单、操作简便，置入猪颈部静脉时无须麻醉，置管后能大大增加血浆采集的速度，减少导管堵塞的可能；同时，增加侧孔分散流速能减轻动物的疼痛或伤害，符合动物伦理学标准；对外延管和管口等进行材质的部分改造能保证留置导管后二次采血的顺畅度，实现多次采血，降低动物采血的成本。本实施例的采血效果与实施例1类似。
实施例4
如图1所示，一种静脉采血导管，包括管体1、连接座5、外延管7、滑扣6和外延管接头8，所述管体1的后端通过连接座5与外延管7一端连接，外延管7另一端与外延管接头8连接。所述管体1为直型单腔导管，所述管体口径范围为2.70mm，口径过细不利于采血，而口径过粗则不适合静脉置管。管体1前端4mm为软质耐磨 性硅胶、聚氯乙烯或聚氨基甲酸酯(PU)材料的锥形管口2，管口2内壁增厚，避免血流磨损管口而留置后二次采血不利。两侧孔3、4位于管体1侧壁对称的两端，侧孔3、4的孔径大小为管体1的2/3，两侧孔3、4相距8mm，近前端的侧孔3距离管口2后方10mm。所述外延管7为透明软质材料，内壁光滑度与所述的管体相近，外延管7上设有控制导管通闭的滑扣6。外延管接头8上设有能连接医用三通阀的滑丝，通过医用三通阀导管能与单采血浆机的耗材连接。本实用新型结构简单、操作简便，置入猪颈部静脉时无须麻醉，置管后能大大增加血浆采集的速度，减少导管堵塞的可能；同时，增加侧孔分散流速能减轻动物的疼痛或伤害，符合动物伦理学标准；对外延管和管口等进行材质的部分改造能保证留置导管后二次采血的顺畅度，实现多次采血，降低动物采血的成本。本实施例的采血效果与实施例1类似。

Claims (8)

  1. 一种静脉采血导管，包括管体、连接座、外延管、滑扣和外延管接头，所述管体的后端通过连接座与外延管一端连接，外延管另一端与外延管接头连接；其特征在于：所述管体的前端管口侧面设有与管体相通的两个侧孔。
  2. 根据权利要求1所述的一种静脉采血导管，其特征在于：两所述侧孔分别位于管体相对的两侧壁上。
  3. 根据权利要求1所述的一种静脉采血导管，其特征在于：所述侧孔的孔径为管体口径的1/3-2/3大小，两侧孔相距3-8mm，靠近管口的侧孔距离所述的管口后方5-10mm。
  4. 根据权利要求1所述的一种静脉采血导管，其特征在于：所述的管体为直型单腔导管，所述的管体口径范围为1.40-2.70mm。
  5. 根据权利要求1所述的一种静脉采血导管，其特征在于：所述管体前端4mm为增厚的耐磨性锥形管口。
  6. 根据权利要求5所述的一种静脉采血导管，其特征在于：所述管口材料为硅胶、聚氯乙烯或聚氨基甲酸酯。
  7. 根据权利要求1所述的一种静脉采血导管，其特征在于：所述外延管为增厚的透明管，其内壁光滑度与所述管体光滑度相近。
  8. 根据权利要求1所述的一种静脉采血导管，其特征在于：所述外延管接头上设有能连接医用三通阀的滑丝，导管能通过医用三通阀与血浆采集机连接。
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