CN213724132U

CN213724132U - Aseptic prefilled syringe seals syringe

Info

Publication number: CN213724132U
Application number: CN202022379056.6U
Authority: CN
Inventors: 陈伟兵; 陈伟伟; 莫晋文
Original assignee: Huizhou Foryou Medical Devices Co Ltd
Current assignee: Huizhou Foryou Medical Devices Co Ltd
Priority date: 2020-10-22
Filing date: 2020-10-22
Publication date: 2021-07-20
Anticipated expiration: 2030-10-22

Abstract

The application discloses an aseptic prefilled syringe, which comprises a push rod, a piston, a needle cylinder and a needle nozzle, wherein the piston is detachably connected to the top end of the push rod; the needle nozzle comprises a second connecting part, the second connecting part is fixedly connected with the first connecting part of the needle cylinder in a matched mode, and the through hole is communicated with the accommodating space and the needle nozzle. The application provides an aseptic embedment syringe in advance passes through the airtight and fixed connection of second connecting portion and the fixed realization needle mouth of first connecting portion cooperation with the cylinder, can realize aseptic embedment syringe in advance's aseptic barrier system of syringe self, need not to use aseptic extranal packing as the final aseptic barrier system of apparatus in addition, has reduced the sterilization process and the packaging process of external packing, has also saved the packaging cost simultaneously.

Description

Aseptic prefilled syringe seals syringe

Technical Field

The application relates to the technical field of medical equipment, in particular to an aseptic prefilled syringe.

Background

At present, gel medical instruments or ointment medicines and the like on the market are mostly packaged in a plastic hose, an organ type hose or an aluminum tube packaging mode, and the problems of difficulty in single-hand extrusion operation, more medicine residues and the like exist. The use of prefilled syringes can better address the above problems, and therefore prefilled syringes are also increasingly used.

However, the pre-filled syringe also has some problems in the production and transportation process, and the sterilization treatment is a great problem. The syringes used for pre-filling and the products to be filled need to be sterilized separately, and the sterilized products to be filled need to be filled into the sterilized syringes in an aseptic production environment, and then sealed in sterilized blister boxes or plastic bags or the like to construct an aseptic barrier system for the pre-filled syringes. And the multiple sterilization process is difficult to control, the process is complex, the investment of a production line is large, and the cost is high.

In addition, the aseptic pre-filled and sealed injector is damaged due to sealing failure in the processes of transportation, storage and sale, so that aseptic opening can not be realized, and the aseptic state can not be ensured. And once the prefilled syringe can not be aseptically opened, whether the prefilled syringe is in an aseptic state when in use can not be ensured, the filled gel or medicine and the like can not be normally used, if the prefilled syringe is used, the problems of bacterial infection and the like can be caused, and the health of a user is seriously threatened.

SUMMERY OF THE UTILITY MODEL

The application mainly provides an aseptic embedment syringe in advance to solve the embedment syringe in advance before the use because the leakproofness inefficacy leads to the aseptic barrier system of product of filling to be destroyed, can't realize aseptic opening, and the aseptic embedment syringe in advance of sterilization production and the problem that the packing cost is high.

In order to solve the technical problem, the application adopts a technical scheme that: providing a sterile pre-filled syringe comprising a push rod; the piston is detachably connected to the top end of the push rod; the needle cylinder comprises a first connecting part and an accommodating space, the piston and the push rod are sleeved and sealed in the accommodating space together, and a through hole is formed in the first connecting part; the needle nozzle comprises a second connecting part, the second connecting part is fixedly connected with the first connecting part of the needle cylinder in a matched mode, and the through hole is communicated with the accommodating space and the needle nozzle.

Wherein, the first connecting part and the second connecting part are fixedly connected in a matching way by one of threaded connection and buckle connection.

Wherein, the threaded connection of at least part of first connecting portion and second connecting portion is interference fit and connects.

Wherein, the threaded connection part of the first connection part and the second connection part is further fixedly connected by any one of welding or bonding.

The second connecting part is internally provided with a blind hole, and the inner wall of the opening end part of the blind hole is matched and hermetically connected with the outer wall of the through hole of the needle cylinder so as to hermetically communicate the needle nozzle with the accommodating space of the needle cylinder.

Wherein, first connecting portion still includes first fixed wall, and first fixed wall sets up with the coaxial interval of the pore wall of through-hole, is provided with at least one of them in external screw thread, internal thread, recess and the arch on the first fixed wall, with second connecting portion cooperation fixed connection.

The second connecting portion further comprises a second fixing wall, the second fixing wall and the blind hole are coaxially arranged at intervals, and the second fixing wall is fixedly connected with the first fixing wall in a matched mode.

The outer wall of the blind hole is provided with a recessed part which is close to the bottom of the blind hole so as to break the needle nozzle at the recessed part and enable the blind hole to form an opening to be communicated with the outside air.

Wherein, aseptic embedment syringe in advance includes the helmet, and the sealed end of needle mouth is located to the helmet cover to protect the needle mouth.

Wherein, the piston is equipped with 3 at least sealing washers, sealing washer and cylinder accommodation space's inner wall interference fit, in order to realize accommodation space's is sealed.

The beneficial effect of this application is: be different from prior art's condition, the aseptic embedment syringe in advance that this application provided passes through the airtight and fixed connection that second connecting portion and first connecting portion cooperation are fixed to realize needle mouth and cylinder, can realize aseptic embedment syringe in advance's aseptic barrier system of syringe self, need not to use aseptic extranal packing as the final aseptic barrier system of apparatus in addition, has reduced the sterilization process and the packaging process of external packing, has also saved the packaging cost simultaneously.

Drawings

FIG. 1 is a schematic diagram of the structure of one embodiment of a sterile pre-filled syringe provided herein;

FIG. 2a is a schematic structural view of the putter 10 of FIG. 1;

FIG. 2b is a schematic left side view of the putter 10 of FIG. 1;

FIG. 3 is a schematic diagram of the construction of the piston 20 of FIG. 1;

FIG. 4a is a schematic view of the structure of the cylinder 30 of FIG. 1;

FIG. 4b is a schematic left side view of the needle cartridge 30 of FIG. 1;

FIG. 5a is a schematic view of the structure of the needle tip 40 of FIG. 1;

FIG. 5b is a schematic cross-sectional view of the tip 40 of FIG. 1;

FIG. 5c is a schematic left side view of the needle tip 40 of FIG. 1;

FIG. 6 is a schematic structural view of another embodiment of a sterile pre-filled syringe provided herein;

FIG. 7 is a schematic diagram of a structure of yet another embodiment of a sterile pre-filled syringe provided herein;

fig. 8 is a schematic flow diagram of an embodiment of a process for producing a sterile pre-filled syringe provided herein.

Detailed Description

The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only a part of the embodiments of the present application, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present application.

It should be noted that if directional indications (such as up, down, left, right, front, and back … …) are referred to in the embodiments of the present application, the directional indications are only used to explain the relative positional relationship between the components, the movement situation, and the like in a specific posture (as shown in the drawings), and if the specific posture is changed, the directional indications are changed accordingly.

In addition, if there is a description of "first", "second", etc. in the embodiments of the present application, the description of "first", "second", etc. is for descriptive purposes only and is not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In addition, technical solutions between various embodiments may be combined with each other, but must be realized by a person skilled in the art, and when the technical solutions are contradictory or cannot be realized, such a combination should not be considered to exist, and is not within the protection scope of the present application.

The sterile medical instrument is a medical instrument which is produced by a manufacturing enterprise, sterilized and supplied in a sterile state, and is used directly by a medical unit without being sterilized, and SAL is 10^-6Wherein sal (sterility assessment level) is a sterility Assurance level, also called a microorganism survival probability. A sterile barrier system refers to a minimal package that prevents microbial ingress and ensures that the medical device is sterile when used. The sterile barrier system comprises a sterile barrier and a sterile opening, and the sterile barrier system is damaged and cannot be opened aseptically. At present, common sterilization modes include high-temperature steam sterilization, EO (Ethylene Oxide) sterilization, radiation sterilization (such as radiation or electron beam sterilization), and the like, and the sterilization mode needs to be selected according to factors such as the property, the material, the stability and the like of a product to be sterilized.

Referring to fig. 1 to 5c, fig. 1 is a schematic structural view of an embodiment of an aseptic pre-filled and sealed syringe provided by the present application, fig. 2a is a schematic structural view of a push rod 10 in fig. 1, fig. 2b is a schematic structural view of a left side view of the push rod 10 in fig. 1, fig. 3 is a schematic structural view of a piston 20 in fig. 1, fig. 4a is a schematic structural view of a syringe 30 in fig. 1, fig. 4b is a schematic structural view of a left side view of the syringe 30 in fig. 1, fig. 5a is a schematic structural view of a nozzle 40 in fig. 1, fig. 5b is a schematic structural view of a cross section of the nozzle 40 in fig. 1, and fig. 5c is a schematic structural view of a left side view of the nozzle 40 in fig. 1.

The sterile pre-filled syringe in this embodiment comprises a plunger 10, a piston 20, a barrel 30, a needle tip 40 and a cap 50. In other embodiments, the sterile pre-filled syringe may be devoid of the cap 50.

The piston 20 is detachably coupled to the top end of the push rod 10. The syringe 30 includes a first connection portion 31 and a receiving space 32, the piston 20 and the plunger 10 are collectively enclosed in the receiving space 32, and a through hole 311 is formed in the first connection portion 31; the needle nozzle 40 comprises a second connecting part 41, the second connecting part 41 is fixedly connected with the first connecting part 31 of the needle cylinder 30 in a matching way, and the through hole 311 is communicated with the accommodating space 32 and the needle nozzle 40.

In one embodiment, the pre-filled medicine is filled in the accommodating space 32 of the syringe 30, and under the pushing of the piston 20 and the push rod 10, the pre-filled medicine can be extruded into the needle nozzle 40 through the through hole 311 and is extruded from the needle nozzle 40, so that the pre-filled medicine is extruded from the sterile pre-filled syringe, and the pre-filled medicine is used.

In this embodiment, the second connection portion 41 and the first connection portion 31 are matched and fixed to realize the airtight and fixed connection between the needle nozzle 40 and the needle cylinder 30, so that an aseptic barrier system of the aseptic pre-filled and sealed syringe can be realized, an aseptic outer package does not need to be used as a final aseptic barrier system of an instrument, the sterilization process and the packaging process of the outer package are reduced, and the packaging cost is saved.

Referring to fig. 2a and 2b, a putter 10 includes a top hand rest platform 11 and a bottom putter attachment portion 12.

The rod connecting portion 12 may be a spiral structure, and the rod connecting portion 12 is fixed to the piston 20 and provides a support for the piston 20. The thickness of the wall of the push rod 10 can be 0.5-2.0 mm, preferably, the thickness of the wall is 1.2-1.5 mm, so that the push rod 10 can be pushed and pulled with certain strength, and the phenomenon that the push rod 10 is broken due to too thin wall thickness is avoided. The length of the push rod 10 can be 80-100 mm to meet the requirement of one-hand operation, and specifically can be 85 mm. The hand rest platform 11 provides hand support for the push-pull putter 10.

The push rod 10 has a certain degree of shape retention and rigidity to satisfy the push-pull and squeeze operations. The push rod 10 may be made of a heat-resistant and thermoplastic material, which is capable of withstanding a high temperature of 121 ℃ or higher and sterilizing the same using high-pressure steam sterilization without being deformed by heat during sterilization. Specifically, polyolefin such as polypropylene, polyethylene, etc. may be used for the push rod 10; polyvinyl chloride resin, polystyrene/polypropylene resin, polyester resin and the like, wherein the polyester resin can be polyethylene terephthalate, polybutylene terephthalate and the like. The pusher 10 may use a material resistant to radiation so as to be able to sterilize the pusher 10 using radiation or electron beams. For example, an antioxidant such as hindered amine or a nucleating agent may be added to the plunger 10 to impart radiation resistance to the plunger 10. Further, by adding an antioxidant such as hindered amine or a nucleating agent to a material such as polyolefin such as polypropylene or polyethylene or polyester resin such as polyethylene terephthalate or polybutylene terephthalate, the push rod 10 can be sterilized by any of high-pressure steam sterilization and radiation or electron beam sterilization while having shape retention, rigidity, heat resistance and thermoplasticity and radiation resistance.

Referring to fig. 3, the piston 20 includes a sealing ring 21, a sealing ring 22, a sealing ring 23, and a piston connecting portion 24.

The sealing rings 21, 22, 23 are in interference fit with the syringe wall 33 of the syringe 30 to realize the sealing and blocking functions, wherein the syringe wall 33 is shown in fig. 4 a. The outer diameters of the sealing ring 21, the sealing ring 22 and the sealing ring 23 are larger than the inner diameter of the syringe barrel wall 33, the diameter interference size can be 0.2-0.5 mm, the sealing and blocking functions of the piston 20 can be guaranteed, and the smooth movement is not easy to cause the difficulty in pushing and pulling the syringe. Specifically, the outer diameters of the seal rings 21, 22 and 23 may be the same, for example, 22.2 mm. Wherein, the sealing washer 21 of bottom ensures that the product of perfusing in advance in the accommodation space 32 effectively extrudes, and middle sealing washer 22 is as the safety ring, and the sealing washer 23 at top realizes that the product of perfusing in advance in the accommodation space 32 is isolated with outer environment, guarantees that the product of perfusing in advance in the accommodation space 32 is in aseptic condition, and a plurality of sealing washers (sealing washer 21, sealing washer 22, sealing washer 23) have multiple protection insurance separation effect, can be better the realization sealed and the separation function. In other embodiments, there may be more than three sealing rings, such as 4, 5, etc., to better achieve the sealing and blocking functions.

The piston 20 is detachably connected to the top end of the push rod 10, and in particular, the piston connecting portion 24 of the piston 20 is detachably connected to the push rod connecting portion 12 of the push rod 10. For example, the piston connecting portion 24 may be an internal thread, and correspondingly and matingly connected to and fixed to an external thread of the rod connecting portion 12, so as to push and pull the rod 10 and thus the piston 20 to move in the accommodating space 32 accordingly.

The piston 20 may be made of a material having antibacterial property, heat resistance and radiation resistance, and may have certain elasticity, such as medical grade natural rubber, synthetic rubber or silica gel, wherein the synthetic rubber may be butyl rubber, halogenated butyl rubber, polyisoprene rubber, or the like.

The syringe 30 includes a first connecting portion 31, a receiving space 32, a syringe wall 33, and a syringe hand rest 34. The first connecting portion 31 is connected to the syringe wall 33, the syringe wall 33 is connected to the syringe hand rest 34, and the inside of the syringe wall 33 is a receiving space 32.

The first connecting portion 31 has a through hole 311 formed therein, and the through hole 311 communicates the accommodating space 32 with the needle nozzle 40. The piston 20 and the push rod 10 can be sleeved and sealed in the accommodating space 32 together, and the piston 20 is in interference fit with the needle cylinder wall 33 to realize sealing and blocking functions. The accommodating space 32 is pre-filled with a medicine, and when the pre-filled medicine is needed, the push rod 10 can be pushed to drive the piston 20 to move towards the first connecting portion 31, and the pre-filled medicine is extruded from the syringe 30 through the through hole 311. First connecting portion 31 and needle mouth 40 cooperation fixed connection, specifically, realize airtight and fixed connection of needle mouth 40 and cylinder 30 through second connecting portion 41 in the needle mouth 40 and first connecting portion 31 cooperation fixed, can realize aseptic prefilled syringe and seal aseptic barrier system of syringe self, need not to use aseptic extranal packing as the final aseptic barrier system of apparatus in addition, reduced the sterilization process and the packaging process of external packing, also saved the packaging cost simultaneously.

The needle nozzle 40 comprises a second connecting part 41, a blind hole 411 is formed in the second connecting part 41, and the inner wall of the opening end part of the blind hole 411 is matched and hermetically connected with the outer wall of the through hole 311, so that the needle nozzle 40 is hermetically connected with the needle cylinder 30, and the needle nozzle 40 is communicated with the accommodating space 32. That is, the shape and size of the inner wall of the open end portion of the blind hole 411 and the outer wall of the through hole 311 are matched with each other, and can be matched and connected to realize sealing. For example, the diameters of the outer walls of the through holes 311 are the same, such as 5mm, and the diameters of the inner walls of the opening end portions of the blind holes 411 are the same, such as 5mm, and the inner walls of the opening end portions of the blind holes 411 and the outer walls of the through holes 311 can be connected in a matching manner, so that the sealing is realized. The outer wall of the through hole 311 may be a cone with a certain taper, and the inner wall of the opening end portion of the blind hole 411 may also be a cone with a certain taper correspondingly matched with the through hole 311, and the tapers of the two may be the same, so as to realize a matching sealing connection. In a specific embodiment, the outer wall of the through hole 311 of the syringe 30 is a 6% taper luer connector, which can be hermetically matched and butted with a common needle or an interface of other medical products, so as to be suitable for different medical application scenarios, meet the requirements of filling of drugs or products such as gel, pre-filling solution and the like, and greatly facilitate the use of the pre-filled drugs. Among them, Luer connector (Luer taper) is a standardized micro non-leaking connector.

In another embodiment, the inner wall of the through hole 311 can be matched and tightly connected with the outer wall of the open end part of the blind hole 411 to realize the tight connection between the needle nozzle 40 and the needle cylinder 30. For example, the inner wall of the through hole 311 is a standard luer with 6% taper, and the outer wall of the open end portion of the blind hole 411 is a luer connector with the same taper, so that the two are in tight fit connection. And the through hole 311 of the needle cylinder 30 can be inserted into a luer connector with the same taper to realize closed matching and butt joint so as to be suitable for different medical application scenes, thereby greatly facilitating the use of the pre-filled medicine. Or the inner wall and the outer wall of the through hole 311 are both provided with luer connectors with 6% taper, so that other instrument products with luer connectors can be inserted into the connectors, and the luer connectors can also be inserted into other instrument products with luer connectors, and the application range of the syringe is improved.

The first connecting portion 31 in the needle cylinder 30 and the second connecting portion 41 in the needle nozzle 40 are fixedly connected in a matched manner, except that the hole wall of the through hole 311 and the hole wall of the blind hole 411 are fixedly connected in a matched manner, matching and connecting can be performed through threaded connection or buckling connection, so that the situation that the needle cylinder 30 and the needle nozzle 40 are loosened or even fall off after being connected in a sealed manner is prevented, the sealing performance is influenced, and the sterile environment is damaged. Such a screw connection or snap connection can be considered as an anti-theft design, with an anti-theft or anti-detachment function. In other embodiments, the first connection portion 31 of the syringe 30 and the second connection portion 41 of the nozzle 40 can be connected by a double fastening connection using a screw connection and a snap connection, so as to prevent falling off and increase the tightness of the fastening connection between the nozzle 40 and the syringe 30.

The first connecting portion 31 further includes a first fixing wall 312, the first fixing wall 312 and the hole wall of the through hole 311 are coaxially arranged at an interval, the first fixing wall 312 is provided with a thread or a concave-convex structure, and the thread or the concave-convex structure arranged corresponding to the second connecting portion 41 is matched and fixedly connected. In this embodiment, the first fixing wall 312 is provided with an internal thread, and the outer wall of the blind hole 411 in the second connecting portion 41 is provided with an external thread, so as to realize a matching threaded connection. That is, while the inner wall of the blind hole 411 and the outer wall of the through hole 311 are fixedly connected in a sealed manner, the outer wall of the blind hole 411 can also be connected with the first fixing wall 312 in a threaded manner, so that the tightness of the fixed connection between the needle cylinder 30 and the needle nozzle 40 is improved, and a double guarantee is provided for maintaining an aseptic barrier after sterilization. In other embodiments, the first fixing wall 312 is provided with a clamping portion, the second connecting portion 41 is correspondingly provided with a clamping portion, and the concave-convex structures of the first fixing wall and the second connecting portion can realize the snap-fit fixing, so that the first connecting portion 31 and the second connecting portion 41 can be fixedly connected by the snap-fit fixing.

At least part of the threaded connection between the first connection portion 31 and the second connection portion 41 may be an interference fit connection, which improves the tightness of the fit connection. The interference fit connection can be realized by adding a convex part on at least part of threads of the first connection part 31, or adding a convex part on at least part of threads of the second connection part 41, or arranging a convex part on at least part of thread structures of the first connection part 31 and at least part of thread structures correspondingly arranged on the second connection part 41. For example, the top of at least part of the thread structure on the outer wall of the blind hole 411 close to the bottom of the blind hole 411 is provided with a thread protrusion 401, and the thread protrusion 401 is in interference fit with the thread on the first fixing wall 312, specifically, the thread protrusion 401 may be an isosceles triangle, the height of the isosceles triangle may be 0.03-0.15 mm, such as 0.05mm, 0.08mm, 0.10mm, 0.12mm, and 0.14mm, the isosceles triangle structure and the thread structure are integrally formed, and the isosceles triangle structure and the thread structure are in interference fit with the thread on the first fixing wall 312 by 0.03-0.15 mm; the threads on the outer wall of the blind hole 411 may be interference fit. The interference size is too big, may lead to the needle mouth 40 to be difficult to screw assembly with cylinder 30, and can improve first connecting portion 31 and second connecting portion 41 and appear damaged risk in the connecting portion when the assembly, and the interference size in height is 0.03 ~ 0.15mm, can improve when connecting closely the type, and it is comparatively easy when guaranteeing screw assembly, and damaged risk reduction appears in assembly connection part structure.

Further, the threaded connection part of the first connection part 31 and the second connection part 41 is further fixedly connected in any one mode of welding or bonding, so that the fixed connection can be better realized, the connection tightness is ensured, the risk that the needle nozzle 40 and the needle cylinder 30 fall off is reduced, the anti-theft function is realized, the aseptic barrier of the product is ensured to be intact, and the product is in an aseptic state before being opened for use. Specifically, after the needle nozzle 40 and the needle cylinder 30 are rotatably assembled, the threaded connection portions of the first connection portion 31 and the second connection portion 41 may be fixedly connected by welding means such as ultrasonic welding, high frequency welding, thermal welding, and the like; or glue such as epoxy resin glue, polyurethane glue, acrylic resin glue, phenolic resin glue and the like is used for dispensing the thread part, and then the needle nozzle 40 and the needle cylinder 30 are assembled in a rotating mode, so that the needle nozzle 40 and the needle cylinder 30 are fixedly bonded.

The inner wall of the syringe wall 33 is a bright-surface non-taper cylinder, has the same inner diameter, can be 22mm, is movably and hermetically connected with the piston 20, realizes the bacteria resistance, and can extrude the pre-filled medicines and the like in the containing space 32 in the syringe wall 33 out of the syringe 30 through the piston 20. The wall thickness of the needle cylinder wall 33 may be 0.5-2.0 mm, such as 0.8mm, 1.0mm, 1.2mm, 1.5mm, 1.8mm, and preferably, the wall thickness is 1.2-1.5 mm. The length of the needle cylinder 30 can be 80-100 mm, such as 90mm, and the length is convenient for operation by one hand, so that the use of the injector is more convenient. The syringe 30 may be filled with 20ml of product, i.e. the receiving space 32 may be pre-filled with 20ml of product.

The barrel 30 has a degree of shape retention and rigidity, and the pre-filled drug can be filled into the barrel 30 for storage and can be squeezed out of the barrel 30 when needed for use. The syringe 30 may be made of a heat-resistant and thermoplastic material, such as medical grade polypropylene, which can withstand a high temperature of 121 ℃ or more and can be sterilized by autoclaving without thermal deformation during sterilization. The syringe 30 may be made of a radiation-resistant material so that the syringe 30 can be sterilized using radiation or electron beams. For example, an antioxidant such as hindered amine or a nucleating agent may be added to the syringe 30 to impart radiation resistance to the syringe 30. Alternatively, the syringe 30 may be made of a material having heat resistance, thermoplasticity, and radiation resistance, and may be sterilized by any of autoclaving, radiation, or electron beam sterilization.

The wall thickness of the blind hole 411 of the needle nozzle 40 may be 0.5-2.0 mm, such as 0.8mm, 1.0mm, 1.2mm, 1.5mm, 1.8mm, and preferably, the wall thickness is 1.2-1.5 mm.

The outer wall of the blind hole 411 of the needle nozzle 40 can also be provided with a recessed part 42, the recessed part 42 is close to the bottom of the blind hole 411, the hole wall at the bottom of the recessed part 42 is the thinnest, the needle nozzle 40 is broken at the recessed part 42, so that an opening is formed in the blind hole 411, the outside air is communicated, the disposable breaking and unsealing use is realized, and the aseptic opening is realized. Specifically, the depressed part 42 can be a V-shaped groove, and is arranged at a position 15mm away from the end part of the needle nozzle 40 close to one side of the bottom of the blind hole 411, and the wall thickness of the bottom of the V-shaped groove and the wall thickness of the hole wall of the blind hole 411 is 0.1-0.3 mm.

The outer wall of the blind hole 411 of the needle nozzle 40 can be provided with strip-shaped convex parts 43 at intervals, so that a stress point is provided during rotary assembly, and the needle nozzle 40 can be more conveniently and rotatably assembled on the needle cylinder 30.

The nozzle 40 has a certain degree of shape and rigidity to enable the fixing of the fitting connection with the cylinder 30. The nozzle 40 may be made of a heat-resistant and thermoplastic material, such as medical grade polypropylene, which can withstand a high temperature of 121 ℃ or higher, and can be sterilized by autoclaving without thermal deformation during sterilization. The nozzle 40 may use a material resistant to radiation to enable sterilization of the nozzle 40 using radiation or electron beams.

The sterile pre-filled syringe may further include a cap 50, the cap 50 being fitted over the sealed end 44 of the nozzle 40 to protect the nozzle 40. When the protective cap 50 is sleeved with the needle nozzle 40, the concave portion 42 of the needle nozzle 40 can be protected, because the hole wall of the blind hole 411 at the concave portion 42 is thinnest and is most easily broken. The cap 50 may be made of a heat-resistant and thermoplastic material, such as medical grade polypropylene, which can withstand a high temperature of 121 ℃ or more, and can be sterilized by autoclaving without thermal deformation during sterilization. The cap 50 may use a radiation-resistant material to enable sterilization of the cap 50 using radiation or electron beams. The thickness of the protective cap 50 may be 0.5 to 2.0mm, preferably 1.2 to 1.5 mm.

In this embodiment, the plunger 10, the piston 20, the syringe 30, the needle nozzle 40 and the protective cap 50 of the aseptic prefilled syringe are made of heat-resistant and thermoplastic materials, and the whole prefilled syringe can be sterilized by high-pressure steam sterilization, and the plunger 10, the piston 20, the syringe 30, the needle nozzle 40 and the protective cap 50 can also be made of radiation-resistant materials, and can be sterilized by radiation or electron beam sterilization. Because each part of the syringe can be sterilized by using a high-pressure steam sterilization or radioactive sterilization mode, after the prefilled medicine is filled and sealed, a proper sterilization mode can be selected according to the property of the prefilled medicine, and only one sterilization operation is used after the prefilled medicine is filled and sealed, so that the sterilization of the whole prefilled syringe is realized, the sterile prefilled syringe is obtained, the sterilization times are reduced, the control difficulty of sterile production is reduced, the production process is simplified, and the production cost is reduced. The needle nozzle 40 is fixedly matched with the first connecting part 31 through the second connecting part 41 to realize the airtight and fixed connection between the needle nozzle and the needle cylinder 30, the sterile barrier system of the sterile pre-filling and sealing injector can be realized, the sterile outer package does not need to be additionally used as the final sterile barrier system of an instrument, the sterilization process and the packaging process of the outer package are reduced, and meanwhile, the packaging cost is also saved. The aseptic prefilled syringe needle nozzle 40 is broken and opened at the concave part 42, so that the aseptic prefilled syringe needle nozzle is opened and used in a disposable destructive mode, aseptic guarantee is achieved, and meanwhile aseptic opening and use are achieved. The packing of syringe form can extrude the medicine of embedment in advance more thoroughly, reduces the volume of remaining, and it is extravagant to reduce the medicine that the medicine can't be extruded and produce the medicine.

Referring to fig. 6, fig. 6 is a schematic structural view of another embodiment of the sterile prefilled syringe provided by the present application. In this embodiment, the sterile pre-filled syringe includes a ram 10X, a piston 20X, a syringe 30X, and a nozzle 40X. The structure and connection manner of the push rod 10X and the plunger 20X may refer to the push rod 10 and the plunger 20 in the corresponding embodiment in fig. 1, and the materials and the like of the push rod 10X, the plunger 20X, the syringe 30X, and the needle nozzle 40X may refer to the push rod 10, the plunger 20, the syringe 30, and the needle nozzle 40 in the corresponding embodiment in fig. 1, which are not described herein again.

The structure of the syringe 30X is substantially the same as that of the syringe 30 of the previous embodiment, and in the embodiment corresponding to fig. 1, the first fixing wall 312 is provided with an internal thread, while in the present embodiment, the first fixing wall 312X is provided with an external thread. Correspondingly, the second connection portion (not shown) of the needle nozzle 40X is provided with an internal thread matching with the external thread, so as to realize the thread matching connection of the needle cylinder 30X and the needle nozzle 40X. Specifically, the second connecting portion further includes a second fixing wall 412X, the second fixing wall 412X and the blind hole (not shown in the drawings) are coaxially arranged at an interval, an internal thread is provided on the second fixing wall 412X, and the second fixing wall 412X is fixedly connected with the first fixing wall 312X in a matching manner, specifically, the second fixing wall 412X may be in a thread matching connection.

In other embodiments, the first fixing wall 312X may be provided with a clamping portion instead of a threaded structure, and a matching clamping portion is provided at a corresponding position on the second fixing wall 412X, so that the first fixing wall 312X and the second fixing wall 412X are fixedly connected in a snap-fit manner.

Further, the bottom of the external thread on the first fixing wall 312X may be provided with a ring of snap (not shown) to prevent the nozzle 40X from being rotatably separated from the syringe 30X by a threaded connection after the screw is rotatably assembled and fixed, and only the connection part of the nozzle 40X or the syringe 30X or both can be broken by one-off breaking to open the sterile pre-filled and sealed syringe, so as to ensure that the sterile barrier is not broken during use. Specifically, can realize fixed cooperation and connect in unidirectional rotation, for example clockwise, the buckle is connected and is made unable rotation in opposite direction and withdraw, for example anticlockwise. The needle nozzle 40X includes a ring band 413X, a buckle (not shown in the figure) may be disposed inside the ring band 413X, and the buckle of the needle nozzle 40X is matched with the buckle of the needle cylinder 30X, so that the needle nozzle 40X can be screwed in only one direction (such as clockwise direction) to perform assembly, fixation and sealing, and thus the anti-theft function is achieved. The second fixing wall 412X and the ring band 413X may be connected in a breakpoint manner, and under the action of the snap, the needle nozzle 40X that has been transferred to the syringe 30X rotates in a direction opposite to the assembling direction, so that the second fixing wall 412X and the ring band 413X of the needle nozzle 40X are broken in a destructive manner, that is, one-time opening is realized, and the aseptic state before opening is maintained.

In this embodiment, the second connection portion and the first connection portion (not shown) are matched and fixed to realize the airtight and fixed connection between the needle nozzle 40X and the needle cylinder 30X, so that an aseptic barrier system of the aseptic pre-filled and sealed syringe can be realized, an aseptic outer package is not required to be additionally used as a final aseptic barrier system of an instrument, the sterilization process and the packaging process of the outer package are reduced, and the packaging cost is saved. The needle nozzle 40X and the needle cylinder 30X are opened at one time in a destructive fracture mode, and the aseptic state before opening is kept. The packing of syringe form can extrude the medicine of embedment in advance more thoroughly, reduces the volume of remaining, and it is extravagant to reduce the medicine that the medicine can't be extruded and produce the medicine.

Referring to fig. 7, fig. 7 is a schematic structural view of yet another embodiment of a sterile pre-filled syringe provided herein. In this embodiment, the sterile pre-filled syringe includes a plunger (not shown), a barrel 30Y, a needle tip 40Y, and a cap 50Y. The structure and connection manner of the push rod and the piston can refer to the push rod 10 and the piston 20 in the corresponding embodiment in fig. 1, and the materials and the like of the push rod, the piston, the syringe 30Y and the needle nozzle 40Y can refer to the push rod 10, the piston 20, the syringe 30 and the needle nozzle 40 in the corresponding embodiment in fig. 1, which are not described again here. The structure of the needle cylinder 30Y and the needle nozzle 40Y can be generally referred to the structure of the needle cylinder 30 and the needle nozzle 40 in fig. 1 to 5c, wherein, in the embodiment, the connection manner of the needle cylinder 30Y and the needle nozzle 40Y is different, and a fixed connection manner of a snap connection is adopted. The structure of the syringe 30Y is similar to that of the syringe 30 in fig. 1, and the syringe 30Y includes a first connection portion 31Y, the first connection portion 31Y includes a first fixing wall 312Y, and the first fixing wall 312Y is provided with a snap-fit portion 3121Y. The structure of the needle nozzle 40Y is similar to that of the needle nozzle 40 in fig. 1, and the needle nozzle 40Y includes a second connecting portion 41Y. The structure of the second connecting portion 41Y can refer to fig. 6 and its corresponding embodiment, the second connecting portion 41Y further includes a second fixing wall 412Y, a clamping portion corresponding to the first fixing wall 312Y is disposed on the second fixing wall 412Y, and the two clamping portions are matched to realize the clamping connection between the second fixing wall 412Y and the first fixing wall 312Y, so as to realize the clamping-fitting-fixing connection between the needle nozzle 40Y and the needle cylinder 30Y.

In this embodiment, the second connection portion 41Y and the first connection portion 31Y are matched and fixed to realize the airtight and fixed connection between the needle nozzle 40Y and the needle cylinder 30Y, so that an aseptic barrier system of the aseptic pre-filled and sealed syringe can be realized, an aseptic outer package does not need to be additionally used as a final aseptic barrier system of an instrument, the sterilization process and the packaging process of the outer package are reduced, and the packaging cost is saved. The needle nozzle 40Y is opened at one time in a destructive breaking manner, and is kept in a sterile state before being opened. The packing of syringe form can extrude the medicine of embedment in advance more thoroughly, reduces the volume of remaining, and it is extravagant to reduce the medicine that the medicine can't be extruded and produce the medicine.

Referring to fig. 8, fig. 8 is a schematic flow chart of an embodiment of a process for producing a sterile prefilled syringe provided herein.

In this embodiment, a production process of a sterile prefilled syringe comprises:

s101: and (4) preparing a pre-filled material.

The pre-filled materials can be organic polymer hydrogel, normal saline, wound cleaning solution/debridement solution, medicinal gel and other substances with certain fluidity. The organic polymer hydrogel is classified into natural organic polymer hydrogel, such as one or more of CMC (Carboxymethyl Cellulose) amorphous hydrogel, alginate amorphous hydrogel, modified starch amorphous hydrogel, carrageenan hydrogel, and the like, and synthetic organic polymer hydrogel, such as carbomer amorphous hydrogel. Wound cleansing/debriding solutions include, for example, solutions containing surfactants such as one or more of tween, span, betaine, poloxamer, and the like, and antibacterial agents; the antibacterial agent may be a mixed aqueous solution of one or more of quaternary ammonium salts, biguanides (e.g., hexamethylene biguanide), alcohols, phenols, benzalkonium chloride, silver, and compounds thereof. The medicinal gel can be metronidazole gel, compound dexamethasone acetate ointment, erythromycin/aureomycin ointment, etc. Specifically, a pre-filled material, such as 0.9% physiological saline or medical hydrogel, is prepared in a dosing reaction kettle.

S102: the prefilled material is filled into the syringe. Specifically, the syringe can be filled into a syringe with an assembled piston through a luer joint of the syringe.

S103: and assembling the needle nozzle on the needle cylinder of the injector to realize the closed sealing. Specifically, the needle nozzle can be assembled on the needle cylinder of the injector in a threaded rotating assembly or bayonet inserting and fixing manner, so that the sealing and fixed connection is realized. When the screw connection is adopted, the screw connection can be further fixed through welding or bonding, and specifically, high-frequency welding can be adopted.

S104: and sterilizing the whole prefilled syringe to obtain the sterile prefilled syringe.

And selecting a proper sterilization mode to sterilize the whole prefilled syringe according to the properties of the prefilled material and the syringe material. Such as high temperature steam sterilization using a steam sterilization cabinet, or radioactive sterilization using an electron accelerator or cobalt 60 sterilization cabinet. Specifically, a steam sterilization cabinet is selected for sterilization, the sterilization temperature can be 121 ℃, and the sterilization time can be 15 min.

And (3) detecting the sterile prefilled syringe, wherein the detection of the tightness of the syringe meets the requirements of Chinese pharmacopoeia, and the sterile detection meets the requirements of the Chinese pharmacopoeia.

The above description is only an example of the present application and is not intended to limit the scope of the present application, and all modifications of equivalent structures and equivalent processes, which are made by the contents of the specification and the drawings, or which are directly or indirectly applied to other related technical fields, are intended to be included within the scope of the present application.

Claims

1. An aseptic prefilled syringe characterized by comprising

A push rod;

the piston is detachably connected to the top end of the push rod;

the needle cylinder comprises a first connecting part and an accommodating space, the piston and the push rod are sleeved and sealed in the accommodating space together, and a through hole is formed in the first connecting part;

the needle nozzle comprises a second connecting part, the second connecting part is matched and fixedly connected with the first connecting part of the needle cylinder, and the through hole is communicated with the accommodating space and the needle nozzle.

2. The sterile pre-filled and sealed syringe according to claim 1, wherein the first connecting part and the second connecting part are fixedly connected in a matching manner by one of a threaded connection and a snap connection.

3. The sterile pre-filled and sealed syringe according to claim 2, wherein at least a part of the threaded connection of the first connection part and the second connection part is an interference fit connection.

4. The sterile pre-filled and sealed syringe according to claim 3, wherein the threaded connection of the first connection part and the second connection part is further fixedly connected by any one of welding or bonding.

5. The sterile pre-filled and sealed injector according to claim 1, wherein a blind hole is formed in the second connecting part, and the inner wall of the opening end part of the blind hole is matched and hermetically connected with the outer wall of the through hole of the needle cylinder so as to hermetically communicate the needle nozzle with the accommodating space of the needle cylinder.

6. The sterile pre-filled and sealed syringe according to claim 5, wherein the first connecting portion further comprises a first fixing wall, the first fixing wall is coaxially arranged with the wall of the through hole at an interval, and the first fixing wall is provided with at least one of an external thread, an internal thread, a groove and a protrusion, and is fixedly connected with the second connecting portion in a matching manner.

7. The sterile pre-filled and sealed syringe according to claim 6, wherein the second connecting portion further comprises a second fixing wall, the second fixing wall is coaxially spaced from the blind hole, and the second fixing wall is fixedly connected with the first fixing wall in a matching manner.

8. The sterile pre-filled and sealed syringe according to claim 5, wherein the outer wall of the blind hole is provided with a recess, and the recess is close to the bottom of the blind hole, so that the needle nozzle is broken off at the recess, and the blind hole is opened to the outside air.

9. The sterile pre-filled and sealed syringe of claim 1, comprising a cap that fits over the sealed end of the nozzle to protect the nozzle.

10. An aseptic pre-filled and sealed syringe as claimed in claim 1, wherein said piston is provided with at least 3 sealing rings, said sealing rings being in interference fit with the inner wall of said receiving space of said syringe to effect sealing of said receiving space.