A prefilled syringe with a protective cover, a component thereof, a component assembling method, and a drug filling method

Abstract

The present invention belongs to the technical field of medical instruments, and in particular, relates to a prefilled syringe with a protective cover, and its components, component assembly method, and drug filling method. The present invention includes a syringe, a mounting portion, and an injection needle, and also includes a protective cover unit sleeved on the syringe body, a syringe ridge arranged on the needle mounting tube and used to engage the protective cover unit, and a needle cover unit sleeved on the needle mounting tube and located in the protective cover unit, and used to release the protective cover unit from the syringe ridge in the opening direction. The needle cover unit has a technical effect of stably covering the needle to avoid exposure after the injection is completed. The advantage of the present invention is that the protective cover and the syringe are designed as an integrated unit, and the protective cover can be opened and the needle can be exposed by a one-step upward push operation. After unlocking the protective cover, the needle cover can be taken off, and the protective cover is locked with the syringe ridge when it returns to the initial position, and a ticking prompt sound is generated during the locking process of the protective cover and the syringe ridge.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to a pre-filled syringe with a protective cover, its components, a component assembly method, and a drug filling method. Background Art

[0002] A pre-filled syringe is a new type of drug packaging form, mainly used for the packaging and storage of high-grade drugs, generally for direct injection, and can also be applied to the cleaning process in surgical operations. After the syringe is used, it needs to be discarded. However, during the discarding process, the needle will cause great trouble to the garbage collectors, and the blood remaining on the needle will cause disease transmission and endanger society.

[0003] In order to avoid the problem that the needle will be exposed after the pre-filled syringe is discarded, the general solution is to put the previously used protective cover back on the needle to avoid the needle from being exposed. However, there are the following disadvantages in doing so. First, the protective cover is a temporary protection device and is extremely easy to fall off from the needle. The probability of this falling-off phenomenon is even higher during violent garbage transportation. Second, the protective cover is generally sleeved on the needle during the factory automation production process. The protective cover often fits tightly with the needle and has a very small diameter. On the one hand, the manual sleeving method is very energy-consuming and affects the work efficiency of nurses. On the other hand, if the needle is not aligned during the sleeving process, it is very likely that the nurse's finger will be pricked by the needle and infected with the patient's disease. Third, the protective cover is generally a disposable part and is often lost after injection. Therefore, the method of putting the protective cover back on to avoid the needle from being exposed is very unreliable.

[0004] To solve this problem, a protective cover structure designed specifically for storing needles has emerged in the market. For example, the Chinese utility model patent with the publication number CN215083511U and the publication date of December 10, 2021, discloses a detachable syringe needle protective cover, which includes a sleeve sleeved on the needle protection cap and a protective head clamped at the end of the needle protection cap and connected to the sleeve. The sleeve and the protective head are integrally formed; a clamping groove matching with the end of the needle protection cap is formed on the inner side of the protective head; the longitudinal sections of the sleeve and the protective head are both regular polygons, and the cross-sectional areas at the connection of the sleeve and the protective head are equal. Through the sleeve sleeved on the needle protection cap, the personnel using the syringe can be protected without changing the specifications of the existing syringe; at the same time, the protective head can play a role in protecting the fingers and prevent being pricked by the needle during use.

[0005] However, the utility model still has the following disadvantages: First, the detachable protective cover makes it inevitable that there is a risk of falling off during the garbage transfer process no matter how exquisitely the structure is designed; Second, the protective head used to sleeve the needle in the utility model needs to be aligned with the needle for installation, which still adds a certain burden to the work of nurses to some extent and is accompanied by the risk of injuring nurses.

[0006] Therefore, in summary, in order to meet the market demand, there is an urgent need for a needle protection cover for a pre-filled syringe that is installed together with the syringe barrel during the product preparation process, can stably cover the needle to prevent exposure after the syringe is used, and is integrated. Summary of the Invention

[0007] The object of the present invention is to provide a pre-filled syringe with a protective cover, its components, a method for assembling the components, and a method for drug filling and sealing. The present invention has an installation part, a protective cover unit, and a needle sleeve unit coaxially arranged with the syringe body. The installation part has a ring-shaped convex rib. The protective cover unit includes a contraction part with a minimum inner diameter smaller than the maximum outer diameter of the ring-shaped convex rib. The contraction part includes a first contraction part and a second contraction part that are respectively close to the distal side and the proximal side of the maximum outer diameter part of the ring-shaped convex rib on the axis, achieving the technical effect of stably covering the needle to prevent exposure after injection.

[0008] The technical solution adopted by the present invention to solve the above problems is: A pre-filled syringe with a protective cover includes a syringe body. The syringe body includes a syringe barrel and an injection needle, and further includes an installation part, a protective cover unit, and a needle sleeve unit coaxially arranged with the syringe body. One end of the installation part is arranged at the distal end of the syringe barrel, and the other end is used to wrap the injection needle. The protective cover unit is sleeved outside the installation part. The needle sleeve unit covers the injection needle and at least part of the installation part. The installation part has a ring-shaped convex rib. The protective cover unit includes a contraction part with a minimum inner diameter smaller than the maximum outer diameter of the ring-shaped convex rib. The contraction part includes a first contraction part and a second contraction part that are respectively close to the distal side and the proximal side of the maximum outer diameter part of the ring-shaped convex rib on the axis. The inner diameters of the first contraction part and the second contraction part can be expanded and can contract after expansion. The minimum inner diameter after expansion is greater than the maximum outer diameter of the ring-shaped convex rib and the maximum outer diameter of the syringe barrel, and the minimum inner diameter after contraction is smaller than the maximum outer diameter of the ring-shaped convex rib.

[0009] A further preferred technical solution lies in that: The inner diameters of the first contraction part and the second contraction part can contract after expansion, and the minimum inner diameter after contraction is smaller than the maximum outer diameter of the ring-shaped convex rib.

[0010] A further preferred technical solution lies in that: When the needle sleeve unit covers the installation part, it can be used to radially push up the first contraction part so that its minimum inner diameter can be expanded to be greater than the maximum outer diameter of the ring-shaped convex rib.

[0011] A further preferred technical solution is that: the protective cover unit further includes a cover body sleeved on the installation part, the first contraction part and the second contraction part are formed at the proximal end of the cover body, and a stop hook is arranged on the cover body and used for fitting the proximal side of the annular rib.

[0012] A further preferred technical solution is that: the protective cover unit includes a cantilever member arranged on the cover body and used for engaging the distal end of the annular rib.

[0013] A further preferred technical solution is that: the stop hook and the cantilever member have a shrinking tendency in the radial direction.

[0014] A further preferred technical solution is that: the needle sleeve unit can be used to lift the cantilever member so that it can cross the annular rib when the cover body is opened.

[0015] A further preferred technical solution is that: the needle sleeve unit includes a needle sleeve body sleeved on the installation part, and a needle sleeve lifting block arranged on the needle sleeve body and used for lifting the cantilever member, and the needle sleeve lifting block can be used to lift the cantilever member so that it can cross the annular rib when the cover body is opened.

[0016] A further preferred technical solution is that: when the proximal end of the cantilever member is engaged with the distal end of the annular rib, the cover body completely covers the injection needle.

[0017] A further preferred technical solution is that: the syringe body further includes a frustum-shaped end head arranged at the distal end of the syringe barrel, and when the protective cover unit is closed, the stop hook is engaged between the frustum-shaped end head and the annular rib.

[0018] A further preferred technical solution is that: the maximum outer diameter of the frustum-shaped end head is greater than the maximum outer diameter of the annular rib.

[0019] A further preferred technical solution is that: the contraction part further includes a third contraction part located at the distal end of the cover body and having a minimum inner diameter smaller than the maximum outer diameter of the frustum-shaped end head.

[0020] A further preferred technical solution is that: the minimum inner diameter of the third contraction part is greater than the maximum outer diameter of the annular rib.

[0021] A further preferred technical solution is that: the protective cover unit further includes a circular tube limiting ring arranged on the cover body and used for engaging the distal end of the frustum-shaped end head.

[0022] A component of a pre-filled syringe with a protective cover further includes a push rod and a piston; wherein:

[0023] The push rod is inserted into and arranged on the piston.

[0024] The piston is installed in the syringe barrel, and when pushing the push rod in the distal direction, it is used to push the liquid medicine out through the injection needle.

[0025] An assembly method for an assembly of a prefilled syringe with a protective cover includes the following steps:

[0026] S1. Axially insert the needle sleeve unit into the protective cover unit.

[0027] S2. Axially sleeve the protective cover unit with the needle sleeve unit on the mounting portion.

[0028] S3. Push the piston into the syringe barrel.

[0029] S4. Insert the push rod into and arrange it on the piston.

[0030] A medicine filling method for a prefilled syringe with a protective cover includes the following steps:

[0031] S1. Grasp the syringe body, and make the syringe barrel perpendicular to the horizontal plane with the proximal opening facing upward.

[0032] S2. Fill the specified medicine into the syringe barrel.

[0033] S3. Insert the sleeve with the piston into the syringe barrel, leaving a gap between the outer ring surface of the sleeve and the inner ring surface of the syringe barrel, and then use the sleeve push rod to push the piston along the inner ring surface of the sleeve into the syringe barrel.

[0034] S4. Insert the push rod into the syringe barrel and install it on the piston to complete the filling process.

[0035] The present invention has the following advantages:

[0036] First, the protective cover and the syringe barrel are integrally designed, having the advantage of preventing detachment. After completely covering and locking the used needle, it is almost impossible for the needle to be exposed again, and the needle can be effectively covered during the entire process from waste transfer to destruction.

[0037] Second, by pushing upward in one step, the protective cover can be opened to expose the needle, without any extra unlocking operation.

[0038] Third, after unlocking the protective cover, the needle sleeve can be conveniently removed, without the need to search for its position during the process of removing the needle sleeve, saving time and effort.

[0039] Fourth, after removing the needle sleeve and completing the injection, when the protective cover returns to the initial position again, it will be locked with the annular convex rib and cannot move, effectively playing a role in shielding the needle tip.

[0040] Fifth, a "tick" prompt sound will be generated during the locking process of the protective cover and the annular convex rib, indicating to medical staff that the syringe has achieved the needle tip shielding effect and can be discarded without the need for observation and confirmation.

[0041] Sixth, the protective cover does not block the main body of the syringe and does not affect the lamp inspection. Description of the Drawings

[0042] Figure 1 It is a schematic structural diagram of the protective cover unit located at the distal end when the needle sleeve unit is not removed in the present invention.

[0043] Figure 2 It is a schematic structural diagram when the protective cover unit moves axially proximally in the present invention.

[0044] Figure 3 It is a schematic structural diagram of exposing the injection needle by removing the needle sleeve unit when the protective cover unit is located at the proximal end in the present invention.

[0045] Figure 4 It is a schematic structural diagram of the protective cover unit located at the distal end after the needle sleeve unit is removed in the present invention.

[0046] Figure 5 It is a schematic structural diagram of the syringe, the mounting part and the injection needle in the present invention.

[0047] Figure 6 It is a schematic structural diagram of the protective cover unit in the present invention.

[0048] Figure 7 It is a schematic structural diagram of the position of the circular tube limiting ring in the protective cover unit in the present invention.

[0049] Figure 8 For Figure 1 The sectional view taken along line AA in

[0050] Figure 9 For Figure 4 The sectional view taken along line BB in

[0051] In the drawings, the components represented by each reference numeral are as follows: syringe A, frustum end B, injection needle C, mounting part 1, protective cover unit 2, needle sleeve unit 3, annular convex rib 101, protective cover main body 201, stop hook 202, cantilever member 203, circular tube limiting ring 206, needle sleeve main body 301, needle sleeve lifting block 302. Detailed Embodiments

[0052] Definition:

[0053] 1. Distal end: Refers to the end facing the injection needle.

[0054] 2. Proximal end: Refers to the end away from the injection needle.

[0055] 3. Axis: Refers to the straight line formed by infinitely extending along the direction of the injection needle.

[0056] 4. Opening direction: Refers to the direction that can expose the injection needle or the needle sleeve unit during operation.

[0057] 5. Closing direction: Refers to the direction that can cover the injection needle or the needle sleeve unit during operation.

[0058] 6. Socketing: Refers to the act of installing component one on the outer surface of component two when the inner diameter of component one is greater than the outer diameter of component two.

[0059] 7. Setting: Refers to all ways such as bonding, clamping, welding, screwing, placing, etc. for combining two components together.

[0060] 8. Lifting: Refers to component one acting on component two with force, causing component two to move in the direction opposite to the position of component one.

[0061] 9. Radial direction: Refers to the straight line direction along the diameter or radius, or the straight line direction perpendicular to the axis.

[0062] The following only describes the preferred embodiments of the present invention and does not limit the scope of the present invention.

[0063] Embodiment: As shown in the appendix Figures 1-9 A prefilled syringe with a protective cover includes a syringe body. The syringe body includes a barrel A and an injection needle C, and further includes a mounting portion 1, a protective cover unit 2, and a needle sleeve unit 3 that are coaxially arranged with the syringe body. One end of the mounting portion 1 is arranged at the distal end of the barrel A, and the other end is used to wrap the injection needle C. The protective cover unit 2 is sleeved outside the mounting portion 1. The needle sleeve unit 3 covers the injection needle C and at least part of the mounting portion 1. The mounting portion has an annular convex rib 101. The protective cover unit 2 includes a contracting portion with a minimum inner diameter smaller than the maximum outer diameter of the annular convex rib 101. The contracting portion includes a first contracting portion and a second contracting portion that are respectively close to the distal side and the proximal side of the maximum outer diameter portion of the annular convex rib 101 on the axis. The inner diameters of the first contracting portion and the second contracting portion can be expanded and can contract after expansion. The minimum inner diameter after expansion is greater than the maximum outer diameter of the annular convex rib 101 and the maximum outer diameter of the barrel A, and the minimum inner diameter after contraction is smaller than the maximum outer diameter of the annular convex rib 101.

[0064] In this embodiment, the syringe barrel A and the injection needle C are essential structures of an existing syringe barrel, and the annular rib 101 included in the mounting portion 1 also widely exists in products on the market. The syringe barrel A does not include the push rod and the sealing rubber head for injection of the syringe barrel, so as to facilitate downstream manufacturers to inject the medicament into the syringe barrel A and install the push rod and the sealing rubber head for encapsulation. During the product preparation process, the protective cover unit 2 is first sleeved on the needle sleeve unit 3, and then the protective cover unit 2 and the needle sleeve unit 3 are jointly installed on the mounting portion 1 to form a pre-filled syringe, which is sleeved in a medical sealing bag in a sterile environment. The protective cover unit 2 jointly engages the annular rib 101 through the first shrinkage portion and the second shrinkage portion to fix the injection needle C after covering it, so as to prevent the needle tip from being exposed again.

[0065] In addition, in the traditional mode, if it is desired to cover the injection needle C when discarding the syringe barrel, the needle sleeve unit 3 needs to be sleeved back on the mounting portion 1 again. This manual sleeving action requires aligning the needle sleeve unit 3 with the needle tip of the injection needle C, which causes nurses to spend a lot of attention on the sleeving action. However, when faced with a large number of injection tasks, it is difficult for nurses to perform the sleeving action accurately and quickly. Slight carelessness may cause the needle tip to prick the hand, affecting the work process of nurses. In severe cases, it may even cause nurses to be infected with the patient's disease. Therefore, the significance of the protective cover unit 2 as a substitute for the needle sleeve unit 3 to sleeve back the injection needle C is that through the sleeving action along the direction of the injection needle C, nurses can complete it without spending too much attention, and can even complete the action without looking at the syringe barrel. It is of great significance for reducing the work pressure of nurses and protecting the health of nurses.

[0066] In addition, when the syringe leaves the factory, the syringe will be inspected by light. The "light inspection" means checking whether the filling and plugging of the syringe are qualified through manual observation through the syringe barrel. Most of the integrated protective covers in the market will affect this process. For example, Chinese Utility Model Patent No. CN214911888U, published on November 30, 2021, discloses a syringe needle protection device and a safety syringe, including a protective outer sleeve, a mounting inner sleeve, and a spring. This way of sleeving the inner and outer sleeves blocks the view inside the syringe barrel and affects the light inspection process. However, the protective cover unit 2 proposed in this embodiment only covers the mounting portion 1 and the injection needle C when the syringe barrel is not in use, and does not cover the syringe barrel A at all, as shown in the appendix Figure 1 As shown, so the structure proposed in this embodiment does not affect the light inspection process.

[0067] The syringe in this embodiment is generally used as follows: first, lift the first contraction portion to expand its inner diameter to a value larger than the maximum outer diameter of the annular convex ridge 101, and then push the shield unit 2 in the opening direction to expose the needle cover unit 3 from the shield unit 2; second, after pushing the shield unit 2 onto the syringe A, the needle cover unit 3 can be pulled off the mounting portion 1 to expose the injection needle C and complete the injection process; third, pull the shield unit 2 along the syringe A in the closing direction, the “closing direction” being the sliding direction covering the injection needle C. When the shield unit 2 is moved to the position that completely covers the injection needle C, the annular convex ridge 101 blocks the shield unit 2 so that it can no longer slide in the opening direction. At this point, the entire syringe is used up and can be directly thrown into a medical waste recycling device to complete the recycling process without having to perform operations such as putting the needle cover unit 3 back onto the mounting portion 1.

[0068] It should be noted that the "following the trend" in the second step means that the nurse's actions of unlocking the protective tube and pulling out the needle sleeve can be done in one go, without having to pay attention to finding the position of the needle sleeve unit 3. This is a design that is very helpful in reducing the workload of nurses.

[0069] When the needle cover unit 3 covers the mounting portion 1 , it can be used to radially lift the first contraction portion so that its minimum inner diameter can be expanded to be larger than the maximum outer diameter of the annular ridge 101 .

[0070] In this embodiment, when the protective cover unit 2 is sleeved on the needle cover unit 3, it will be lifted up by the needle cover unit 3 and the first contraction portion, so that when the needle cover unit 3 exists, the protective cover unit 2 can directly slide along the opening direction without performing any unlocking operation, further simplifying the workload of nurses.

[0071] In addition, the needle cover unit 3 is a device necessary for the prefilled syringe to maintain a sealing effect. The first contraction portion utilizes the needle cover unit 3 necessary for the syringe as an unlocking device that will not be engaged with the annular ridge 101 when opening the first step. When opening the protective cover unit 2, there is no need to deliberately lift up to unlock the first contraction portion, nor to operate any unlocking device to release the engagement of the protective cover unit 2 with the annular ridge 101. This is an extremely clever design.

[0072] In addition, it should be noted that the needle cover unit 3 uses the existing pre-filled needle cover (material and shape have been standardized) instead of a non-standard special-shaped cover. The advantages of this are: 1. It does not change the user's usage habits; 2. It does not need to re-evaluate the chemical compatibility of the rubber cover, which greatly reduces the project development cycle and product registration cycle; 3. It enhances customer confidence.

[0073] The protective cover unit 2 also includes a protective cover body 201 sleeved on the mounting portion 1, the first contraction portion and the second contraction portion are formed at the proximal end of the protective cover body 201, and a stop hook 202 is arranged on the protective cover body 201 and used to fit the proximal side of the annular ridge 101.

[0074] In this embodiment, the term “sheathed on” indicates that the shield body 201 completely covers the outer surface of the syringe A and can slide freely thereon. The shield body 201 is provided so that the injection needle C is not exposed by pulling the needle cover unit 3 in the closing direction after the needle cover unit 3 is discarded. In order to prevent the shield body 201 from being completely separated from the shield body 201 when the shield body 201 is pulled in the closing direction, the first stop hook 202 is provided to stop the shield body 201 after the shield body 201 completely covers the injection needle C, thereby limiting the shield body 201 from continuing to move in the closing direction.

[0075] In addition, the distal end of the first stop hook 202 is tilted up under the pushing action of the syringe A. After the nurse finishes the injection, she can hold the syringe A with one hand and then use one finger, usually the thumb, to push the distal end of the first stop hook 202, thereby returning the entire protective cover unit 2 to the injection needle C. This one-handed operation design greatly improves the comfort of the nurse during use.

[0076] The protective cover unit 2 includes a cantilever member 203 which is arranged on the protective cover body 201 and is used for engaging with the distal end of the annular ridge 101 .

[0077] In this embodiment, during the first step of the operation process of pushing the protective cover unit 2 in the opening direction so that the needle sleeve unit 3 is exposed from the protective cover unit 2, the cantilever member 203 is lifted up by the needle sleeve unit 3 and is not engaged with the annular convex ridge 101, so that the protective cover body 201 can slide freely in the opening direction, and the friction force between the cantilever member 203 and the surface of the syringe A is consistent with the friction force between the first stop hook 202 and the outer side of the syringe A, thereby achieving a further friction fixation effect.

[0078] In addition, when the operation process is in the third step, at this time the needle sleeve unit 3 has been removed. The cantilever 203 drops instantly when passing over the annular ridge 101 as the shield main body 201 slides down, and is jacked up by the side surface of the annular ridge 101. At the same time, the first stop hook 202 is jacked up by the side surface of the other end of the annular ridge 101. The cantilever 203 and the first stop hook 202 are respectively abutted against both sides of the annular ridge 101, so that the shield main body 201 can be firmly fixed on the syringe barrel A.

[0079] The stop hook 202 and the cantilever 203 have a shrinking tendency in the radial direction.

[0080] In this embodiment, as shown in the attached Figure 2 figure, when the first stop hook 202 moves in the opening direction, it will be jacked up and bent by the outer side surface of the syringe barrel A, thereby generating a frictional force on the outer side surface of the syringe barrel A. This frictional force will not limit the sliding process of the shield main body 201 on the syringe barrel A, but will limit the shield main body 201 from sliding distally in the natural state without external force. For example, during the injection process by a nurse, it will not slide towards the injection needle C on the syringe barrel A. The significance of such a design is that it does not affect the operation process of the nurse during the injection process.

[0081] In addition, due to the shrinking tendency in the radial direction, when the cantilever 203 drops over the annular ridge 101, it will produce a "tick" sound effect, aiming to remind the nurse that the injection needle C of this syringe barrel has been completely covered and locked by the shield main body 201 and can be directly discarded.

[0082] The needle sleeve unit 3 can be used to jack up the cantilever 203 so that it can cross over the annular ridge 101 when opening the shield main body 201.

[0083] Furthermore, the needle sleeve unit 3 includes a needle sleeve main body 301 sleeved on the mounting portion 1, and a needle sleeve jacking block 302 provided on the needle sleeve main body 301 and used to jack up the cantilever 203. The needle sleeve jacking block 302 can be used to jack up the cantilever 203 so that it can cross over the annular ridge 101 when opening the shield main body 201.

[0084] In this embodiment, the needle sleeve lifting block 302 is arranged on the needle sleeve body 301, generally arranged in a ring at the end position where the needle sleeve body 301 is sleeved on the mounting portion 1. The position of the needle sleeve lifting block 302 on the needle sleeve body 301 is generally designed to fit against the side surface of the annular convex rib 101, aiming to enable the cantilever member 203 to pass through the annular convex rib 101 unobstructed after being lifted. Therefore, the height of the needle sleeve lifting block 302 is generally the same as the height of the annular convex rib 101 in the product design. However, this fitting design is not necessary, and there can also be a gap between the two, and the width of this gap can be within the range that does not obstruct the free passage of the cantilever member 203.

[0085] In addition, the needle sleeve lifting block 302 is often a structure that appears on the needle sleeve body 301. The cantilever member 203 proposed in this embodiment precisely utilizes this structure so that it will not be engaged with the annular convex rib 101 during the first opening step, which is an extremely ingenious design.

[0086] When the proximal end of the cantilever member 203 is engaged with the distal end of the annular convex rib 101, the shield body 201 completely covers the injection needle C.

[0087] In this embodiment, "completely covering" means that the outermost end of the shield body 201 exceeds the outermost end of the injection needle C, which is also called the complete covering effect.

[0088] The syringe body further includes a frustum-shaped end B provided at the distal end of the syringe barrel A. When the protective cover unit 2 is closed, the stop hook 202 is engaged between the frustum-shaped end B and the annular convex rib 101.

[0089] In this embodiment, a groove is formed between the frustum-shaped end B and the annular convex rib 101. As shown in the appendix Figure 5 This groove can just accommodate the stop hook 202, converting it from an outwardly expanded state to a contracted state, reducing the volume of the syringe when discarded.

[0090] In addition, when the shield body 201 is in the closed state, the frustum-shaped end B can also be engaged with the stop hook 202, so that the shield body 201 needs to apply a greater force to bend the stop hook 202 to break away from the engaged state with the frustum-shaped end B during the first opening step, forming a "starting force". It is the existence of this starting force that prevents the syringe barrel from sliding up onto the syringe barrel A accidentally during transportation and exposing the needle sleeve unit 3.

[0091] The maximum outer diameter of the frustum-shaped end B is greater than the maximum outer diameter of the annular convex rib 101.

[0092] The contraction part further includes a third contraction part located at the distal end of the shield main body 201 and having a minimum inner diameter smaller than the maximum outer diameter of the frustum end B.

[0093] In this embodiment, when the minimum inner diameter of the third contraction part is smaller than the maximum outer diameter of the annular convex rib 101, when the shield main body 201 is opened, the proximal end of the third contraction part will be pushed up by the annular convex rib 101, thereby restricting the shield main body 201 from continuing to move axially along the syringe A.

[0094] In addition, when the minimum inner diameter of the third contraction part is slightly smaller than the maximum outer diameter of the annular convex rib 101, when the shield main body 201 is opened, the proximal end of the third contraction part will be slightly pushed up by the annular convex rib 101, but with a slight force, the third contraction part can be elastically expanded to cross over the annular convex rib 101, and then be engaged between the annular convex rib 101 and the frustum end B, so that the opened shield main body 201 is fixed on the outer ring surface of the syringe A in a clamped manner.

[0095] The minimum inner diameter of the third contraction part is larger than the maximum outer diameter of the annular convex rib 101.

[0096] In this embodiment, when the minimum inner diameter of the third contraction part is larger than the maximum outer diameter of the annular convex rib 101, when the shield main body 201 is opened, the proximal end of the third contraction part will be pushed up by the frustum end B, thereby restricting the shield main body 201 from continuing to move axially along the syringe A. The frustum end B has higher strength and has a better limiting effect than the annular convex rib 101.

[0097] The protective cover unit 2 further includes a circular tube limiting ring 206 provided on the shield main body 201 and used for engaging the distal end of the frustum end B.

[0098] In this embodiment, the circular tube limiting ring 206 is a form of the third contraction part. In order to prevent the shield main body 201 from moving infinitely in the opening direction, after the injection needle C is completely exposed, the inner side surface of the circular tube limiting ring 206 will abut against the side surface of the annular convex rib 101 to restrict the further movement of the shield main body 201. In actual operation, the nurse does not have to carefully adjust the position of the shield main body 201, and only needs to push it forcefully in the opening direction to make the shield main body 201 stay just exposing the needle tip, and it is convenient to directly push it to a suitable position in the closing direction with the thumb after the injection is completed.

[0099] In addition, the circular tube limiting ring 206 has a certain deformation ability. When the minimum inner diameter of the circular tube limiting ring 206 is slightly smaller than the maximum outer diameter of the annular convex rib 101, this deformation ability enables the nurse to pull the shield body 201 forcefully in the opening direction, causing the circular tube limiting ring 206 to pass over the annular convex rib 101 and engage with the frustum end B, resulting in a better fixing effect of the shield body 201 and avoiding the risk of sliding when the shield body 201 is fixed solely by the friction force generated between the stop hook 202 and the cantilever member 203 and the syringe barrel A.

[0100] In addition, as shown in the Figure 3 attachment, when the circular tube limiting ring 206 engages with the annular convex rib 101 or the frustum end B, the conical head of the mounting portion 1 can be completely exposed, which has great advantages for subcutaneous angled injection.

[0101] A component of the pre-filled syringe with a shield described above further includes a push rod and a piston; wherein:

[0102] The push rod is inserted into the piston;

[0103] The piston is installed in the syringe barrel A and is used to push the liquid medicine out through the injection needle C when pushing the push rod in the distal direction.

[0104] In this embodiment, the key lies in that the push rod and the piston are detachably connected together, so that the piston can be conveniently installed in the syringe barrel A in a mechanical automation manner.

[0105] An assembly method of a component of a pre-filled syringe with a shield includes the following steps:

[0106] S1. Axially insert the needle sleeve unit 3 into the shield unit 2;

[0107] S2. Axially sleeved the shield unit 2 with the needle sleeve unit 3 on the mounting portion 1;

[0108] S3. Push the piston into the syringe barrel A;

[0109] S4. Insert the push rod into the piston.

[0110] In this embodiment, the needle sleeve unit 3 is first installed in the shield unit 2, which is beneficial to the automatic assembly steps of the syringe component, can simplify the production line process, reduce the cost during the component installation process, and further improve the market competitiveness.

[0111] A medicine filling method of a component of a pre-filled syringe with a shield includes the following steps:

[0112] S1. Place the syringe barrel: Grasp the syringe body and make the syringe barrel A perpendicular to the horizontal plane with the proximal opening facing upward.

[0113] In this embodiment, the "grasping" step generally uses a robotic arm with programmed design. The core of the program design is to make the syringe barrel A maintain a vertical state when it reaches the position to be sealed. In this way, the liquid level after filling the medicine is perpendicular to the axis of the syringe barrel A, so that there is no air left or there is less air left after encapsulation, but it does not affect the injection process.

[0114] S2. Fill the medicine: Fill the specified medicine into the syringe barrel A.

[0115] In this embodiment, the "specified medicine" refers to the medicine filled according to the customer's needs. For example, for a manufacturer filling the COVID-19 vaccine, the specified medicine is the inactivated novel coronavirus.

[0116] S3. Insert the sleeve and stopper: Insert the sleeve with the piston into the syringe barrel A. There is a gap between the outer ring surface of the sleeve and the inner ring surface of the syringe barrel A. Then use the sleeve push rod to push the piston along the inner ring surface of the sleeve into the syringe barrel A.

[0117] In this embodiment, the piston is a common device for pushing medicine in a syringe, usually made of medical rubber, in a compressed state in the sleeve, and will expand to fit the inner side surface of the syringe barrel A after leaving the sleeve.

[0118] In addition, the sleeve is a slender steel pipe and is inserted into the syringe barrel A from the crimped edge. Then use the sleeve push rod installed in the sleeve to send the piston to the specified position. The specified position means that after the piston leaves the sleeve, it can just be above the liquid level of the medicine, with no air left or less air left, but it does not affect the injection process.

[0119] S4. Install the push rod: Insert the push rod into the syringe barrel A and install it on the piston to complete the sealing process.

[0120] In this embodiment, there is an installation groove for installing the push rod at the proximal end of the piston. Use the robotic arm to rotate and insert the push rod into the installation groove.

[0121] S5. Conduct lamp inspection on the sealed syringe, label it, and finally complete the packaging.

[0122] The embodiments of the present invention have been described in detail above with reference to the accompanying drawings. However, the present invention is not limited to the above embodiments. Within the scope of knowledge possessed by those of ordinary skill in the art, various modifications can be made without departing from the spirit of the present invention. These are all non-creative modifications and are protected by the patent law as long as they are within the scope of the claims of the present invention.

Claims

1. A prefilled syringe with a protective cover, comprising a syringe body, the syringe body including a barrel (A), an injection needle (C), and a needle sleeve unit (3), characterized in that, it further includes a mounting portion (1) and a protective cover unit (2) arranged coaxially with the syringe body. One end of the mounting portion (1) is arranged at the distal end of the barrel (A), and the other end is used to wrap the injection needle (C). The protective cover unit (2) is sleeved outside the mounting portion (1). The needle sleeve unit (3) covers the injection needle (C) and at least part of the mounting portion (1). The mounting portion has an annular rib (101). The protective cover unit (2) includes a constriction portion with a minimum inner diameter smaller than the maximum outer diameter of the annular rib (101). The constriction portion includes a first constriction portion on the distal side and a second constriction portion on the proximal side that are respectively close to the maximum outer diameter portion of the annular rib (101) on the axis. Wherein the inner diameters of the first constriction portion and the second constriction portion can be expanded, and the minimum inner diameter after expansion is greater than the maximum outer diameter of the annular rib (101) and the maximum outer diameter of the barrel (A); the inner diameters of the first constriction portion and the second constriction portion can be contracted after expansion, and the minimum inner diameter after contraction is smaller than the maximum outer diameter of the annular rib (101); when the needle sleeve unit (3) covers the mounting portion (1), it can be used to radially lift the first constriction portion so that its minimum inner diameter can be expanded to be greater than the maximum outer diameter of the annular rib (101).

2. A prefilled syringe with a protective cover according to claim 1, characterized in that, the protective cover unit (2) further includes a cover body (201) sleeved on the mounting portion (1). The first constriction portion and the second constriction portion are formed at the proximal end of the cover body (201), and a stop hook (202) is arranged on the cover body (201) and used to fit the proximal side of the annular rib (101).

3. A prefilled syringe with a protective cover according to claim 2, characterized in that, the protective cover unit (2) includes a cantilever member (203) arranged on the cover body (201) and used to engage the distal end of the annular rib (101).

4. A prefilled syringe with a protective cover according to claim 3, characterized in that, the stop hook (202) and the cantilever member (203) have a radial contraction tendency.

5. A prefilled syringe with a protective cover according to claim 3, characterized in that, the needle sleeve unit (3) can be used to lift the cantilever member (203) so that it can cross the annular rib (101) when opening the cover body (201).

6. A prefilled syringe with a protective cover according to claim 3, characterized in that, when the proximal end of the cantilever member (203) is engaged with the distal end of the annular rib (101), the cover body (201) completely covers the injection needle (C).

7. A prefilled syringe with a protective cover according to claim 2, characterized in that, The syringe body further includes a frustum-shaped end (B) provided at the distal end of the barrel (A). When the protective cover unit (2) is closed, the stop hook (202) is engaged between the frustum-shaped end (B) and the annular rib (101).

8. A prefilled syringe with a protective cover according to claim 7, wherein, the maximum outer diameter of the frustum-shaped end (B) is greater than the maximum outer diameter of the annular rib (101).

9. A prefilled syringe with a protective cover according to claim 7, wherein, the shrinkage part further includes a third shrinkage part located at the distal end of the cover body (201) and having a minimum inner diameter smaller than the maximum outer diameter of the frustum-shaped end (B).

10. A prefilled syringe with a protective cover according to claim 9, wherein, the minimum inner diameter of the third shrinkage part is greater than the maximum outer diameter of the annular rib (101).

11. A prefilled syringe with a protective cover according to claim 7, wherein, the protective cover unit (2) further includes a circular tube limiting ring (206) provided on the cover body (201) and used for engaging the distal end of the frustum-shaped end (B).

12. An assembly of a prefilled syringe with a protective cover according to any one of claims 1 to 11, wherein, it further includes a push rod and a piston; wherein: the push rod is inserted into the piston; the piston is installed in the barrel (A), and when the piston is pushed in the distal direction, it is used to push the liquid medicine out through the injection needle (C).

13. An assembling method for an assembly of a prefilled syringe with a protective cover according to claim 12, wherein, it includes the following steps: S1. Axially insert the needle sleeve unit (3) into the protective cover unit (2); S2. Axially sleeve the protective cover unit (2) with the needle sleeve unit (3) on the mounting part (1); S3. Push the piston into the barrel (A); S4. Insert the push rod into the piston.

14. A medicine filling method for an assembly of a prefilled syringe with a protective cover according to claim 12, wherein, it includes the following steps: S1. Place the barrel: Make the barrel (A) perpendicular to the horizontal plane with the proximal opening facing upward; S2. Fill the medicine: Fill the specified medicine into the barrel (A); S3. Sleeve and plug: Insert the sleeve with the piston into the barrel (A), leaving a gap between the outer ring surface of the sleeve and the inner ring surface of the barrel (A), and then use the sleeve push rod to push the piston along the inner ring surface of the sleeve into the barrel (A); S4. Install the push rod: Insert the push rod into the barrel (A) and install it on the piston.

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