WO2013182000A1

WO2013182000A1 - Disposable sterile injector for retaining microparticles

Info

Publication number: WO2013182000A1
Application number: PCT/CN2013/076271
Authority: WO
Inventors: 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: 2012-06-07
Filing date: 2013-05-27
Publication date: 2013-12-12
Also published as: CN102671262B; CN102671262A

Abstract

Disclosed is a disposable sterile injector for retaining microparticles, which comprises an outer barrel (3), a liquid-ejecting rod (4) placed in the outer barrel (3) and a needle seat (5) on one side of the front end of the outer barrel (3) for mounting a needle. The injector also comprises a filtration unit (6). The filtration unit (6) is arranged with a filter membrane (12). The filter membrane (12) is attached to a liquid outlet and closed at the front end and open at the back end. A thickening interlayer is set on the top end of a traditional injector; a circular unilateral hanging filtration unit is embedded in the interlayer. The filtration unit can be open and closed automatically as the liquid flows, and retains the microparticles in the injection solution once; no microparticles of ≥0.45um appear in the solution ejected, which ensures the safety of the injection.

Description

Single use sterile particle trapping syringe

The invention belongs to the field of medical devices, and relates to a syringe, in particular to a disposable sterile particle trapping syringe.

Background technique

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. In view of the serious consequences of particulate contamination in liquid medicine, the Pharmacopoeia of China stipulates that no more than 10 insoluble particles with a particle size > ΙΟ μ π ΐ (millimeters) per ml of infusion.

The sources of particles in the liquid may be the following:

1. Brought in the production process of articles and infusion sets.

2. Incorrect operation during drug preparation. For example, when multiple drugs are compatible, there may be more than 1~50 μm of drug particles in the drug solution.

3. Glass debris inhaled when the glass ampoule is opened.

4. Needle puncture bottle stopper Dissolve the cuttings under the drug.

5. 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.

Administration by intravenous route is a common treatment. At present, the disposable sterile syringe structure is very classic, it can only perform the simple aspiration injection function, and the improvement research is more focused on how to ensure the disposable use and the safety of the treatment of the syringe itself. It involves how to eliminate particulate pollution. With the improvement of the medical quality management system and the improvement of the patient's requirements for the purity of the treatment means, strengthening the control of insoluble particles in the intravenous solution and reducing the harm of insoluble particles to intravenous patients are increasingly being valued by hospitals and patients. However, so far no filter device of any kind can be safely used in the syringe. The filter device used in the infusion set cannot be transferred to the syringe due to the different retention principle. Except for the connection filter syringe, the micro filter is installed. The product of the one-piece disposable sterile particulate retention syringe has not yet appeared.

Summary of the invention

SUMMARY OF THE INVENTION It is an object of the present invention to provide a disposable sterile particulate retentive syringe which is provided with a microfilter and which is capable of particulate trapping of the injectable solution.

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.

0 匪; The insertion of the thickness of the upper cover is 0. 05 匪, 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, and 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.

With the above design, 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 μππ or more, and the syringe with the trapping liquid can directly push the muscles. Note that injection safety is guaranteed. On the other hand, when the syringe with the trap is used in combination with the infusion, the injection of the liquid into the bottle has removed the particles generated by other links. Therefore, 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.

The advantages of the invention are:

1. One-time use of sterile microparticle-retaining syringes for single use.

2. The appearance of a single-use sterile particle-retaining syringe is very simple, but the particle retention rate is 100% when used.

3. The use of sterile microparticle-retaining syringes does not change the traditional injection procedure of medical personnel in the field of nursing injection, retaining the traditional appearance, and making the injection operation completely consistent with the traditional operation from the visual, intuitive, and sensory right-angle planes.

4. 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.

5. 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.

6. Ensuring the operation of the injection field No matter what method is used to dissolve the drug, and the channel from which the particles come from, the drug can be pushed out as desired, and the complete retention of the particles can be realized without being introduced into gravity infusion and bagged infusion. It avoids the harm caused by particles entering the human blood circulation system during rescue, intravenous drip, and intravenous injection, and the particle retention rate safety factor is 100%.

DRAWINGS

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.

detailed description

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.

As shown in Fig. 1, 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:

As shown in FIG. 2, 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. Between the upper cover 11 and the lower cover 13 and at the position of the grid 14, 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. Forming the diaphragm 1 ("sandwich" concept).

5毫米; 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 μ πι), thickness 00. 1 1-0. 12mm.

Referring to Fig. 3, 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. In the middle 22, 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).

In order to assemble the filter device 6, the front end of the syringe outer cylinder 3 of the present invention needs to be adjusted. 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;

b) As shown in Figures 4 to 5, 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); 3) On the side of the front wall 31 against the needle holder 5 ("one-sided" concept), 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 groove thickness is 0.35 mm, the width is 12. mm, and the length is 15 legs) for accommodating the filtering device 6, and the positioning groove 33 is larger in size than the film of the filtering device 6. Sheet 1 (inlet edge) 0. 05mm (see Figure 4), leaving space for opening and closing of diaphragm 1 when using the syringe, without snapping and closing freely ("embedding"concept);

4) In order to increase the strength of the syringe barrel, 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.

In the assembly, 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).

In use, the variation of the membrane 1 in the disposable sterile particulate retentive syringe filtration device of the present invention is shown in Figure 8, wherein:

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.

Through the above injection operation procedure, it can be seen that when the syringe equipped with the filtering device has unpredictable or unavoidable particles in the liquid medicine, 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.

From the safety consideration of the product itself, 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.

The function and effect of the single-use sterile microparticle-retaining syringe of the present invention will be further explained below by related experiments.

Experiment 1: Inspection of filter membrane material in disposable sterile particulate trapping syringe

This experiment was conducted on the filter membrane material used in the disposable sterile microparticle-retaining syringe to confirm the retention effect, hydrophobic gas permeability and safety performance of the membrane material used. The test results for the microporous polyethersulfone filter are shown in Table 1, indicating that the selected filter membrane material is available. Similar tests are required before other filters are used. The results are not listed here.

Table 1 Batch-by-batch test report of disposable medical microporous polyethersulfone filter

Inspection basis ΥΖΒ/Country 1979-2011 Report date 2012, 4, 16

Inspection items Standard requirements Measured results Unqualified number Sampling plan Judgment

Set

Appearance should be clean, non-polluting, non-folding, conforming 0 32

No corners, no damage

Diameter < 10mm error must not exceed the payment 0

Size ± 0.2mm. 13

Physical >10mm filter error can not exceed

Performance is over ±0.3mm.

Filtration rate Filters particles above the nominal pore size

The number should be ≥95%

Filtration speed -0.093Mpa under the filter speed should be paid 0

>7mL/cm ² .min

Particles above 5μπι in the eluent

The particle contamination should not exceed 50 / mL, 0

The number of particles dyed 15μπι-25μπι is not exceeded.

Over 10 / mL,

The number of particles larger than 25μπι should not exceed

Over 3.0 / mL 20

Hydrophobic water blocking pressure greater than 15KPa

Gas flow unit area lOmin gas outflow payout 0

The amount of output should be ≥25mL/mm ²

Test solution and blank solution consume high manganese

The difference between the volume of the chemical reduction potassium acid solution should not be 0.6 0 Performance quality exceeds 2.0mL

pH difference between test solution and blank solution pH value 0.30 0

Should not exceed 1.5.

Grid

The absorbance of the UV absorption test solution should be no greater than 0

Luminosity 0.1.

Biological bacteria should be less than 0.5E|i/mL within 0

Performance Toxin Conclusion:

Advantages: Excellent heat resistance and chemical resistance, no powder or fiber shedding, good toughness. Experiment 2: Syringe particle rejection test

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. In addition, the corresponding filter membrane was taken out, and the microscopic surface of the filter membrane was observed to block the 45 μm particles to 100%.

Control experiment: For the same injection solution as described above, open the drug in the usual way with a normal syringe of the same specification. The extracted liquid is transferred to the glass slide of the bio-inverted microscope, and the number of particles in the counting solution is observed under the microscope. The average results are reported in the control group of Table 2. Table 2 The content of particles in the liquid of different syringes ( /ml)

The experimental results show that the use of ordinary syringes, there are a large number of particles in the injection, does not meet the relevant standard indicators in the industry (see Table 3), analyze the source of the particles, can be summarized as Table 4. And After the disposable sterile particle trapping syringe of the invention is used, all the particles of 45 μm in the injecting solution are trapped, thereby ensuring the safety of the injection solution. Table 3: Test indicators for each method

Table 4: Sources of particulates in injections

No. Name of the granule Source

1 rubber particles injection needle edge puncture cutting rubber cover

2 plastic particles

3 glass crumb particles

4 Crystal particles Drug placement and compatibility

5 fiber particles indoor environment and infusion set self-contamination

6 fluff, dust, indoor environment and infusion set self-contamination

7 carbon black particles drug production process

8 fatty acid microparticles clinical fat emulsion solution

9 Insoluble colloidal particles Chinese medicine preparation, polysaccharides Experiment 3, filter holder strength test in filtration device

In the disposable sterile particle trapping syringe, 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.

Method: 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.

Result:

1), no looseness. 2), no deformation.

3), as early as.

4), not detached.

5), not pierced.

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.

Experiment 4: Anti-liquid impact damage test of filter membrane in filter device

In this experiment, the ability of the membrane to resist liquid impact damage was examined by physiological saline.

Method: Using 20ml-times sterile microparticle-retaining syringe, one-time extraction of 20ml of saline solution, divided into 2ml, one end, a total of 10 times, each time to observe whether there is liquid oozing and whether the liquid is smooth, after each launch Remove the full set of side-mounted filter devices placed in the top of the syringe and place them under a biological microscope to see if they are intact.

RESULTS: The results of the above-mentioned 10 ml filtration test showed that there was no leakage or leakage of the drug solution, and the drug solution was quickly passed through, and the filter membrane was not damaged by perforation.

Experiment 5: Microparticle retention of sterile microparticle-retaining syringes in different specifications for single use

Based on the above studies, the inventors obtained a series of disposable single-use sterile particle-retaining syringes. See Table 5 for its configuration.

Table 5 - Secondary use of sterile microparticle-retaining syringes lml~100ml size filter configuration table Syringe Round film straight name Bubble pressure Bulb Thickness Flow Operating temperature No. Specification Diameter

1 1ml 4mm LMG-PES0.45 m 0.23Mpa 0.12-0.13mm 60ml/min/cm ² <40°C

2 2ml 4mm LMG-PES0.45 m 0.23Mpa 0.12-0.13mm 60ml/min/cm ² <40°C

3 2.5ml 4mm LMG-PES0.45 m 0.23Mpa 0.12-0.13mm 60ml/min/cm ² <40°C

4 3ml 5 mm LMG-PES0.45 m 0.23Mpa 0.12-0.13mm 60ml/min/cm ² <40°C

5 5ml 5 mm LMG-PES0.45 m 0.23Mpa 0.12-0.13mm 60ml/min/cm ² <40°C

6 10ml 6mm LMG-PES0.45 m 0.23Mpa 0.12-0.13mm 60ml/min/cm ² <40°C

7 20ml 6mm LMG-PES0.45 m 0.23Mpa 0.12-0.13mm 60ml/min/cm ² <40°C

8 30ml 8 mm LMG-PES0.45 m 0.23Mpa 0.12-0.13mm 60ml/min/cm ² <40°C

9 50ml 10mm LMG-PES0.45 m 0.23Mpa 0.12-0.13mm 60ml/min/cm ² <40°C

1 60ml 10mm LMG-PES0.45 m 0.23Mpa 0.12-0.13mm 60ml/min/cm ² <40°C

0

1 100ml 10mm LMG-PES0.45 m 0.23Mpa 0.12-0.13mm 60ml/min/cm ² <40°C

1

Remarks: The above 1ml specification syringe rubber plug needs to be changed to a right angle plane, which is convenient for the whole device of the filter membrane. Adopt specifications:

1. One-time use of sterile microparticles to retain the syringe, specifications lml ~ 100ml a total of 11 specifications.

2. One-time use of sterile injection needles, size 0. 4mn! ~ 1. 6mm.

3. According to the injection operation, insert the cork to simulate the dissolution of the drug after the completion of the drug extraction operation, 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 .

4. 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.

5. Remove the inner stent and the filter membrane from the whole device, and observe the stained surface of the filter under a biological microscope. The particles with a particle size of 1 μ πΓ300 μm (micrometer) or larger can be seen under the microscope. The insoluble particles can be recognized by the naked eye. . It can be seen that the microparticles are completely trapped on the upper surface of the trapping syringe filter, indicating that the above-mentioned particle size Ι μ πκ 5 μ m, ΙΟ μ πκ 15 μ πι, 20 μ m, 50 μ m, 300 can be intercepted by the disposable sterile particle trapping syringe. μ m or larger, and the particles can be completely removed at one time.

Conclusion: The above experimental results show that there is no particulate particles in the ejection liquid of each specification syringe provided by the present invention.

Experiment 6: Principle analysis of the syringe filter device and the infusion device filter device of the present invention

With the microporous membrane particle trapping under pressure, a one-time retention of large and small particles can be achieved. However, 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.

Under pressure, such as microporous polyethersulfone filter 0. 45 μ πι, diameter 25mm filter through vacuum vacuum filter bottle suction filtration of Chinese herbal turbid liquid extract, the upper surface of the filter shows full retention of particles, can be more than cut Ι μ πκ 5 μ πι, ΙΟ μ πκ 20 μ πι, 50 μ m, 300 μππ or larger particles, insoluble particles can be recognized by the naked eye, and there are no particulate particles in the filtrate, which is enough to explain the pressure interception (or "gravity interception") is the key.

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. Single-use sterile microparticle-retaining syringe with polyethersulfone membrane (aperture

0. 45 μ m).

The composition and function of the optimal disposable sterile particulate retentive syringe of the present invention are described in detail above. However, the scope of protection of the present invention should not be limited to the drawings and embodiments, for example, According to the design concept of the invention, a similar product can be produced by externally implanting a filtering device at the tip of a disposable sterile syringe, or by attaching a horizontal microfiltration device to the inside. These forms of particulate trapping syringes are still within the scope of the present disclosure. If someone avoids the setting shown in the drawing, it should be understood that this intention to evade infringement is still an infringement of the present invention.

Claims

^ 1. Disposable sterile particle trapping syringe, including an outer cylinder, a push rod placed in the outer cylinder and a needle holder 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. The utility model further comprises a filtering device, wherein 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.

A disposable sterile particulate trapping syringe according to claim 1, wherein said filter means is embedded in a topmost front wall of the outer cylinder.

The disposable aseptic particulate trapping syringe according to claim 2, wherein the filtering device comprises an insert, the filter membrane is fixed in the insert, and the outermost front wall of the outer cylinder is supported by the needle seat The side of the outer cylinder is arcuately opened to form an assembly long hole matching the insert, and the insert is fitted in the long hole.

The disposable aseptic microparticle-retaining syringe according to claim 3, wherein the insert comprises a pin head, a connecting piece and a hollow membrane ring which are integrally connected in series, and the filter membrane is fixed on the membrane ring. , the connecting piece and the membrane ring are inside the outer cylinder, and the pin head is outside the outer cylinder.

The disposable aseptic microparticle-retaining syringe according to claim 1 or 2 or 3 or 4, wherein the filter membrane is fixed between a top cover and a lower cover of a pair of buckles to form a diaphragm. The filter membrane is assembled in the form of the membrane.

The disposable aseptic microparticle-retaining syringe according to claim 5, wherein 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 membrane, and the upper cover And the solid part of the ring body of the lower cover are respectively provided with indented fixed protrusions and protrusions.

The disposable aseptic microparticle-retaining syringe according to claim 5 or 6, wherein the inner side of the outermost front wall of the outer cylinder has a positioning groove corresponding to the position of the diaphragm, and the positioning groove has a size larger than the diaphragm. Edge size 0. 05 legs.

8. A single use sterile particulate retention syringe according to claim 7, wherein the outermost front wall of the outer cylinder is thickened to 4 mm.

The disposable aseptic particulate trapping syringe according to claim 8, wherein the front end of the outer cylinder is a semi-conical force-receiving side wall thickened to 2 mm on the side on which the diaphragm is attached.

0. 12mm. The thickness of the filter film is 0. 05mm, the thickness of the filter film is 0. 11-0. 12mm The insertion head has a thickness of 12 mm, the thickness of the connecting piece is 0.332 mm, and the thickness of the film ring is 0.35 匪; 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.