WO2013182000A1 - Injecteur stérile jetable pour retenir des microparticules - Google Patents

Injecteur stérile jetable pour retenir des microparticules Download PDF

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Publication number
WO2013182000A1
WO2013182000A1 PCT/CN2013/076271 CN2013076271W WO2013182000A1 WO 2013182000 A1 WO2013182000 A1 WO 2013182000A1 CN 2013076271 W CN2013076271 W CN 2013076271W WO 2013182000 A1 WO2013182000 A1 WO 2013182000A1
Authority
WO
WIPO (PCT)
Prior art keywords
outer cylinder
syringe
filter
membrane
particles
Prior art date
Application number
PCT/CN2013/076271
Other languages
English (en)
Chinese (zh)
Inventor
杨昌燕
陈志成
周培聪
Li SUN (孙丽)
Original Assignee
广州均和纳米新材料科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 广州均和纳米新材料科技有限公司 filed Critical 广州均和纳米新材料科技有限公司
Publication of WO2013182000A1 publication Critical patent/WO2013182000A1/fr

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Classifications

    • 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
    • A61M5/3145—Filters incorporated in syringes
    • 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
    • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M2005/342—Off-center needles, i.e. needle connections not being coaxial with the longitudinal symmetry axis of syringe barrel

Definitions

  • the invention belongs to the field of medical devices, and relates to a syringe, in particular to a disposable sterile particle trapping syringe.
  • Infusion therapy is an important treatment, especially intravenous infusion and intravenous injection. Because the drug directly enters the blood circulation system, its efficacy is rapidly used. However, in recent years, the harm caused by the injection of foreign bodies and particulates in infusions has caused widespread concern, and it has become urgent to solve the problem of particulate contamination.
  • Intravenous drip and intravenous injection microparticles are unintentionally added to the swimming, insoluble exogenous substances and soluble and undissolved drugs, insoluble particles including rubber particles, polyester flakes, thin chips, color points Inorganic salts, insoluble inorganic salts, activated carbon microparticles, fibers, and chemical particles produced by improper combination of drugs, if these particles are mixed into the infusion, clinical application may cause an infusion reaction, which may lead to acute reactions or long-term potential risks. For example, a large amount of particles injected into the human body may cause serious damage to the body.
  • the latent period of the particles in the body can be metabolized for decades, and the larger particles are blocked by the blood circulation in the small blood vessels, causing different degrees of tissue necrosis and damage, such as Phlebitis, pulmonary granuloma, thrombosis and vascular embolism, induce tumor formation, etc., and even endanger the patient's life.
  • tissue necrosis and damage such as Phlebitis, pulmonary granuloma, thrombosis and vascular embolism, induce tumor formation, etc., and even endanger the patient's life.
  • the Pharmacopoeia of China stipulates that no more than 10 insoluble particles with a particle size > ⁇ ⁇ ⁇ ⁇ (millimeters) per ml of infusion.
  • the sources of particles in the liquid may be the following:
  • Needle puncture bottle stopper Dissolve the cuttings under the drug.
  • the plastic needle of the infusion device can also increase the amount of particles in the liquid by 1. 6 ⁇ 27. 6 times when inserting the liquid bottle rubber plug.
  • the main way to eliminate particulate contamination in the infusion is to add a microfilter to filter the solution before it enters the body.
  • researchers have installed a filter device with a filter on the infusion set.
  • the filter device is installed at the end of the infusion set (the lower end of the drip bucket).
  • the filtration principle is realized by the negative pressure generated by the liquid sinking in the bottle. filter.
  • Adding a filter device at this stage does solve some of the particulate contamination problems, but the price of the infusion set with the filter device is significantly increased, which increases the burden on the patient; on the other hand, the filter pack After the infusion set is filtered, 500 ⁇ 1500ml of liquid is filtered, and as the particles accumulate, there is also a phenomenon that the membrane pores of the filter device are clogged, affecting the initial flow rate, and the filtration rate is attenuated, so that the infusion set cannot be normally infused.
  • the disposable sterile particle trapping syringe of the invention comprises an outer cylinder, a push rod placed in the outer cylinder and a needle seat for loading the needle on the front end side of the outer cylinder, and the outer cylinder and the needle seat are connected by the liquid outlet, A filtering device is disposed, the filtering device is provided with a filtering membrane attached to the liquid outlet, and is closed to the front end and opened to the rear end.
  • the filter device is embedded in the topmost front wall of the outer cylinder.
  • the filter device includes an insert, and a filter membrane is fixed in the insert.
  • the top end front wall of the outer cylinder is disposed on the side of the needle seat along an arc of the outer cylinder to form an assembly long hole matching the insert. Inside the long hole.
  • the insert comprises a pin head, a connecting piece and a hollow membrane ring which are integrally connected in series, the filter membrane being fixed on the membrane ring, the connecting piece and the membrane ring being inside the outer cylinder, and the pin head being outside the outer cylinder.
  • the filter membrane is fixed between a top cover and a lower cover of a pair of buckles to form a membrane, and the filter membrane is assembled in the form of the membrane.
  • the upper cover and the lower cover are ring bodies, and the hollow portion of the ring body is provided with a mesh for lining the filter film, and the solid portions of the upper cover and the lower cover are respectively provided with indented fixed protrusions and protrusions.
  • the positioning of the positioning groove is larger than the size of the diaphragm edge 0. 05 leg.
  • the outermost front wall of the outer cylinder is thickened to 4 mm.
  • the front end of the outer cylinder is a semi-conical force-receiving side wall thickened to 2 mm on the side where the diaphragm is mounted.
  • the insertion of the thickness of the upper cover is 0. 05 ⁇
  • the thickness of the lower cover is 0. 05 mm
  • the thickness of the filter film is 0. 11-0.
  • the thickness of the pin head is 12 mm
  • the thickness of the connecting piece is 0.332 mm
  • the thickness of the film ring is 0. 35 mm
  • the length of the arc of the pin head is larger than the length of the arc of the long hole of the outer tube assembly.
  • the single-use sterile trapping syringe of the present invention can temporarily remove the particles in the injection liquid, and absolutely control the particles in the ejection liquid to no longer generate 45 ⁇ or more, and the syringe with the trapping liquid can directly push the muscles. Note that injection safety is guaranteed.
  • the filter device at the end of the infusion device only needs to block the infusion of the infusion device. Particles, which will reduce the blockage of the filter device at the end of the infusion set, the attenuation of the filtration rate, and the occurrence of initial flow.
  • Disposable sterile microparticle-retaining syringe presents a sandwich-embedded filter device.
  • the diaphragm is statically closed, the suction is self-opening, and the pusher is self-closing. At the same time, the liquid must be forced through the membrane channel to effectively block the particles.
  • the design of the structure is only on the top of a conventional and ordinary syringe, with a thickened interlayer embedded with a circular single-sided hanging filter device, which can open and close with the liquid microfluid and realize the pumping of the solvent. Suck, do whatever you want.
  • Figure 1 is a schematic view showing the structure of a single-use sterile particle trapping syringe of the present invention
  • Figure 2 is a schematic view showing the structure of a diaphragm in a disposable sterile microparticle-retaining syringe of the present invention
  • Figure 3 is a structural view of a filtering device in a single-use sterile microparticle-retaining syringe of the present invention
  • Figure 4 is a cross-sectional view showing the front end structure of the outer cylinder 3 in a disposable sterile particle-retaining syringe of the present invention
  • Figure 5 is a left side view of Figure 4 (outer tube part);
  • Figure 6 is an assembled view of the filter device 6 in the disposable sterile particle trapping syringe of the present invention
  • Figure 7 is a structural view of the front end of the syringe outer tube after the assembly of Figure 6 is completed
  • Fig. 8 is a view showing a state of change of the diaphragm 1 in the filtering device 6 when the disposable sterile particle trapping syringe of the present invention is used, wherein the A frame is in a state of being sucked, the B frame is in a liquid absorption state, and the C frame is a liquid pushing state, D The frame is in the state of completion of injection.
  • the invention provides a disposable sterile particle trapping syringe, which is modified for the existing structure syringe, and a filtering device is added at the top end thereof to achieve the purpose of intercepting and ensuring safe injection of the particles in the liquid medicine during the injection.
  • the present invention provides a single-use sterile particle trapping syringe, which comprises an outer cylinder 3 of a conventional ordinary syringe, a push rod 4 placed in the outer cylinder, and a front end side of the outer cylinder for needle loading.
  • the needle holder 5, which is characterized by the present invention, further comprises a filtering device 6 which is embedded in the innermost wall of the outermost end of the outer cylinder 3 and which faces the position of the liquid outlet of the needle holder 5.
  • the filter unit 6 consists of a diaphragm 1 and an insert 2, as shown in Fig. 3. among them:
  • the diaphragm 1 is sequentially pressed by the upper cover 11, the filter membrane 12 and the lower cover 13 to form an elliptical sheet-like body, and the upper cover 11 and the lower cover 13 are filter holders, and are formed in a ring shape.
  • the hollow portion of the ring body is provided with a mesh 14 for lining the filter film 12, and the solid portions of the upper cover 11 and the lower cover 13 are respectively provided with indented fixed protrusions and protrusions, and the filter film 12 is a sheet body.
  • the upper cover 11 and the lower cover 13 are pressed by the indentations and the protrusions, and then the hot film is pressed, and the filter film 12 is pressed between the upper and lower covers.
  • the upper cover 13 is made of a polypropylene material, and has a thickness of 0.15 legs; the lower cover 13 is made of PP material, and has a thickness of 0.05 mm ; the filter film 12 can be made of a polyethersulfone film (aperture 0). 45 ⁇ ⁇ ), thickness 00. 1 1-0. 12mm.
  • the insert 2 is integrally formed in a sheet shape, and includes a pin head 21, a connecting piece 22 and a membrane ring 23 which are integrally connected in series, and is shaped like a rivet.
  • the outer edge of the pin head 21 is curved, the inner connecting piece 22 is connected, and the connecting piece is connected.
  • an open loop is formed to form a diaphragm 23 for mounting the diaphragm 1.
  • the insert 2 is integrally made of PP material, the pin head 21 is 12 mm thick, the connecting piece 22 is thick 0. 2 mm, the film ring thickness is 0. 35 mm, and the insert 2 is 15 mm overall.
  • the diaphragm 1 is placed at the position of the diaphragm 23 of the insert 2, and fixed by a heat press to form a filter unit 6 (see Fig. 3). It is apparent that the size of the filter membrane 12 and the membrane ring 23 in the filter unit should match the size of the syringe (11 specifications in specifications lml to 100 ml).
  • Adjustments include: a) The top outlet of the syringe is calculated from the center line and displaced 3 mm to the center axis of the syringe;
  • the front wall 31 of the top end of the syringe barrel 3 is thickened (see Figures 4 and 5) and can be generally thickened to 4 mm for the purpose of placing the top of the syringe barrel 3
  • the wall is thickened by the original thinner (1.5 legs) ("thickening" concept) to facilitate the opening design of the following three);
  • an elongated hole 32 is opened along the arc of the outer cylinder (for example, a hole thickness of 0.35 legs and an arc length of 20 legs) is used for The filter device 6 is inserted, and the arc length (20 mm) of the assembly long hole 32 is smaller than the arc length of the pin head 21 (the pin head thickness is 36 mm, the length is 2 101111) to position the filter device 6; and the front wall 31 of the outer tube 3
  • the inner side is disposed with the positioning hole 33 at a position where the long hole 32 is to be assembled (the
  • the side wall of the outer tube 3 on the side on which the long hole 32 is formed needs to be thickened in such a manner that the side wall of the outer tube 3 forms a semi-conical force-receiving side wall 34 ( Referring to Fig. 5, the thickness is 2 mm X width 15 mm X length 20 mm), the thickened reinforcing force side wall 34 can ensure that the outer tube 3 has sufficient strength and load when the filter device 6 is inserted into the assembled long hole 32 of the front wall 31 of the outer cylinder 3. Force ("strengthening" concept).
  • the above-mentioned one to four) adjusted thickening reinforced single-side slotted syringe outer cylinder 3 is integrally molded.
  • the diaphragm 1 of the filtering device is directed toward the syringe outer cylinder 3, inserted into the front wall 31 from the fitting long hole 32 into the positioning recess 33 (see Fig. 6), and the pin head 21 of the insert 2 is caught in the fitting long hole 32.
  • External fixation (“hanging” concept), see Figure 7, shows the structure of the front end of the outer cylinder of the syringe after assembly, and the assembly is used to obtain a one-time use of a thickened and reinforced laminated embedded circular one-side filter device.
  • Sterile particle trapping syringe see Figure 1, the needle is attached to the needle hub 5).
  • the A-frame shows that the disposable sterile particle-retaining syringe has been air-drawn, and the syringe push-pull rod 4 is at the foremost end of the syringe, and is ready to be sucked. At this time, the diaphragm 1 is located in the groove and is in a closed state;
  • B-frame shows the single-use sterile microparticle-retaining syringe to perform the pumping action.
  • the syringe push-pull rod 4 is pulled back, the liquid medicine enters from the liquid-suction hole, and the diaphragm 1 is pushed back into the syringe barrel. At this time, the diaphragm 1 Is turned on;
  • the C-frame shows a one-time use of a sterile microparticle-retaining syringe to perform a pushing action, and the syringe push-pull rod 4 is pushed forward, and the hydraulically-driven diaphragm 1 is closed from the open state to the forward state, and the liquid medicine is pushed out through the aperture of the diaphragm 1;
  • the D-frame shows the completion of the single-use sterile microparticle-retaining syringe pusher, at which point the syringe push-pull rod 4 is pushed to the foremost end of the syringe, the diaphragm 1 is located in the groove, and is closed, and the liquid medicine has passed through the diaphragm 1 The pores are pushed out, and the particles present in the liquid are intercepted by the membrane 1 and remain in the syringe.
  • the diaphragm can effectively intercept the particles and ensure the input into the human body. There are no particles in the liquid, which eliminates particulate contamination that seriously plagues the safety of the infusion.
  • the filter holder (upper cover and lower cover) is made of PP material, does not contain bisphenol A substance, and its safety is fully in line with EU standards, and has the advantages of not easy to be broken and stable. Even in the case of high temperature heating, no harmful substances are released; the filter membrane is formed by embedding hot pressing once.
  • Appearance should be clean, non-polluting, non-folding, conforming 0 32
  • Diameter ⁇ 10mm error must not exceed the payment 0
  • Filtration rate Filters particles above the nominal pore size
  • the number should be ⁇ 95%
  • the particle contamination should not exceed 50 / mL, 0
  • the number of particles dyed 15 ⁇ -25 ⁇ is not exceeded.
  • the number of particles larger than 25 ⁇ should not exceed
  • the amount of output should be ⁇ 25mL/mm 2
  • the absorbance of the UV absorption test solution should be no greater than 0
  • Bio bacteria should be less than 0.5E
  • This experiment examines the amount of particulate contamination when the glass bottle is opened.
  • Method 100 injections of ampoules and antibiotic glass bottles were respectively taken, and the drug was opened by the "disposable sterile microparticle-retaining syringe" of the present invention.
  • the size of the syringe was 10 ml, and the filter membrane was determined by the experiment PES.
  • the film has a flow rate of 0.14-0. 12mm.
  • the film has a flow rate of 31-44ml/cm 2 /min, a working temperature of 20 V, and a film thickness of 0.11-0. 12mm.
  • the drug solution was taken out and pushed out to the glass slide of the bio-inverted microscope through a syringe.
  • the number of particles in the drug solution was counted under a microscope, and the average results were recorded in the test group of Table 2.
  • the corresponding filter membrane was taken out, and the microscopic surface of the filter membrane was observed to block the 45 ⁇ m particles to 100%.
  • the membrane ring of the filter device (the filter holder composed of the upper cover and the lower cover) is attached to the membrane, and is opened and closed with the action of the syringe.
  • This experiment uses the push-pull airflow to test the stent and the filter membrane. The strength of the tensile strength of the tensile bending was observed.
  • a sterile microparticle-retaining syringe was used with a l ⁇ 50 ml empty cut. The empty cut ends with the fastest back to the end and back to the top for an action, ending 10 times. After each movement, observe whether the top-side bracket of the syringe is displaced in the inner cylinder, and then take out the filter device under the biological microscope to observe whether the filter-embedded stent is loose, whether the filter is deformed, and whether the stent is in the top of the syringe. Maintain the horizontal plane, whether the stent is inserted into the syringe as it is, whether the enveloping edge of the annular filter is detached, and whether the filter membrane is perforated between the membrane ring and the diaphragm.
  • the above 1 ⁇ 10 experimental results show that the filter membrane has not fallen off, the annular filter envelope is not detached, the stent device is not loose, and the filter membrane is not perforated, that is, everything is intact.
  • the filter device of the invention for emptying and disposable sterile particle-retaining syringe has no damage at one time, and its strength is qualified.
  • each deionized water is taken according to the nominal metering of the syringe, and then pushed into the 200ml measuring cup, each specification 10 times, a total of 110 simulations .
  • the measuring cup liquid was transferred 10 times to the biological inverted microscope piece, and the filtrate was observed under the microscope. The results showed no particle particles.
  • the end filter of the infusion set is microgravity (only relying on the gravity of the liquid), which is easy to block the pores of the membrane. Unless the gap between the membrane pore size and the particle size is large, the flow rate of the filtrate can be prevented from attenuating, but the pore diameter is increased. Large and obviously weakened the interception effect of the particles.
  • the principle of the disposable sterile particle trapping syringe of the present invention is that the filtration is carried out by pressure pushing, which is different from the filtering principle of the existing infusion set. Therefore, in the present invention, the pore size change of the membrane has no obvious attenuation hindrance, and as the fluence increases, the amount of particulate accumulation in the membrane surface also increases, and a part of the membrane is blocked, but the filtrate flow rate does not show a decay tendency.

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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

L'invention concerne un injecteur stérile jetable pour retenir des microparticules, qui comprend un corps externe (3), une tige d'éjection de liquide (4) placée dans le corps externe (3) et un siège d'aiguille (5) sur un premier côté de l'extrémité avant du corps externe (3) pour monter une aiguille. L'injecteur comprend également une unité de filtration (6). L'unité de filtration (6) comprend une membrane de filtre (12). La membrane de filtre (12) est fixée à une sortie de liquide et fermée à l'extrémité avant et ouverte à l'extrémité arrière. Une couche intermédiaire d'épaississement est placée sur l'extrémité supérieure d'un injecteur classique; une unité de filtration de suspension unilatérale circulaire est incorporée dans la couche intermédiaire. L'unité de filtration peut être ouverte et fermée automatiquement lorsque s'écoule le liquide et retient une fois les microparticules dans la solution d'injection; aucune particule ≥ 0,45 µm n'apparaît dans la solution éjectée, ce qui garantit la sécurité de l'injection.
PCT/CN2013/076271 2012-06-07 2013-05-27 Injecteur stérile jetable pour retenir des microparticules WO2013182000A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201210185950.7A CN102671262B (zh) 2012-06-07 2012-06-07 一次性使用无菌微粒截留注射器
CN201210185950.7 2012-06-07

Publications (1)

Publication Number Publication Date
WO2013182000A1 true WO2013182000A1 (fr) 2013-12-12

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2013/076271 WO2013182000A1 (fr) 2012-06-07 2013-05-27 Injecteur stérile jetable pour retenir des microparticules

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CN (1) CN102671262B (fr)
WO (1) WO2013182000A1 (fr)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102671262B (zh) * 2012-06-07 2014-04-16 中山未标生物新技术有限公司 一次性使用无菌微粒截留注射器
CN108434551B (zh) * 2018-04-13 2021-05-14 山东中医药大学 一种带有注射液过滤功能的滴管
CN112277333A (zh) * 2019-07-25 2021-01-29 江苏正迈过滤技术有限公司 一种医用过滤器及其生产方法
CN113350619A (zh) * 2021-07-08 2021-09-07 上海振浦医疗设备有限公司 一种内置式膜片过滤注射器

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1363128A (en) * 1920-02-11 1920-12-21 Shigezo Nishitani Injection-syringe
US4137917A (en) * 1977-05-12 1979-02-06 Cohen Milton J Syringe filter unit
CN101648040A (zh) * 2009-09-04 2010-02-17 上海一童医疗用品有限公司 一次性使用精密过滤注射器
CN201612904U (zh) * 2010-02-27 2010-10-27 孙风林 具有过滤功能的注射器
CN102406971A (zh) * 2011-12-29 2012-04-11 雷红力 过滤式注射器
CN102671262A (zh) * 2012-06-07 2012-09-19 杨昌燕 一次性使用无菌微粒截留注射器
CN202666105U (zh) * 2012-06-07 2013-01-16 杨昌燕 一次性使用无菌微粒截留注射器

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN200998481Y (zh) * 2006-07-31 2008-01-02 王哲兴 一次性使用无菌过滤型注射器
CN201959347U (zh) * 2011-01-25 2011-09-07 上海振浦医疗设备有限公司 一次性使用精密过滤注射器

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1363128A (en) * 1920-02-11 1920-12-21 Shigezo Nishitani Injection-syringe
US4137917A (en) * 1977-05-12 1979-02-06 Cohen Milton J Syringe filter unit
CN101648040A (zh) * 2009-09-04 2010-02-17 上海一童医疗用品有限公司 一次性使用精密过滤注射器
CN201612904U (zh) * 2010-02-27 2010-10-27 孙风林 具有过滤功能的注射器
CN102406971A (zh) * 2011-12-29 2012-04-11 雷红力 过滤式注射器
CN102671262A (zh) * 2012-06-07 2012-09-19 杨昌燕 一次性使用无菌微粒截留注射器
CN202666105U (zh) * 2012-06-07 2013-01-16 杨昌燕 一次性使用无菌微粒截留注射器

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CN102671262A (zh) 2012-09-19

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