Needle head protective sleeve and pre-filled syringe adopting same

Abstract

The utility model provides a syringe needle protective sleeve which comprises a sleeve body with a sleeve body near end and a sleeve body far end, a cavity for containing a syringe needle assembly is arranged in the sleeve body, the sleeve body near end is used for being connected with a needle seat of a pre-filled syringe in a sealed mode, and a bacterium-blocking waterproof breathable film is arranged at the sleeve body far end and communicated with the cavity. The bacteria-blocking waterproof breathable film can only be breathable, and the needle head can be sterilized and disinfected through ethylene oxide gas. Meanwhile, liquid and bacteria can be isolated through the bacteria-blocking waterproof breathable film, and the bacteria-blocking waterproof requirements of the medicine in the pre-filled syringe are met. Besides, when the double-chamber pre-filled syringe is used for mixing medicine, exhaust can be carried out through the bacteria-blocking waterproof breathable film, the plunger can be pushed more smoothly, and effective medicine mixing can be carried out on the premise that the needle head protection sleeve is not taken down.

Description

Technical Field

[0001] The utility model belongs to the technical field of medical devices, and particularly relates to a needle protective cover and a prefilled syringe using the same. Background Art

[0002] Prefilled syringes, also known as pre-filled syringes, contain the intended medication pre-filled within the syringe. Widely recognized as a drug delivery system for injectable drugs, they are particularly suitable for treating chronic diseases requiring repeated dosing. They are currently widely used for biologics such as monoclonal antibody therapies, cytokines, vaccines, and peptides. When not in use, the sharp metal needle of a prefilled syringe is often covered with a needle guard to prevent accidental needle sticks. This needle guard also protects the prefilled biologic from contact with external bacteria, which could compromise its efficacy. To prevent contact between the biologic and external fluids, bacteria, and other substances, the needle guard is hermetically connected to the syringe body. Furthermore, these prefilled syringes are often sterilized after the needle guard and syringe body are assembled and pre-filled with the medication. However, as can be seen above, the presence of the needle guard prevents effective sterilization of the syringe needle, thus impacting its subsequent effectiveness. In summary, sterilizing the metal needle of prefilled syringes with needle guards is currently a challenge.

[0003] Furthermore, a dual-chamber prefilled syringe, such as that shown in Chinese patent CN201020655107.7, can mix two medications within its syringe barrel, simplifying the mixing process and preventing the medications from being repeatedly exposed to the natural environment, which could affect their properties. Consequently, similar dual-chamber prefilled syringes are becoming increasingly popular and widely used. However, because the barrel must be degassing when the plunger is pushed, this type of dual-chamber prefilled syringe requires the needle guard to be removed before the plunger can be pushed to mix the two medications. Certain prefilled medications (such as anti-tumor biological agents) cannot be exposed to the outside world before injection, and the mixing process must be performed in a sealed environment, where the needle guard cannot be removed. Therefore, this type of dual-chamber prefilled syringe cannot meet the needs of this situation. Utility Model Content

[0004] In view of the above shortcomings of the prior art, the purpose of the present invention is to provide a needle protective cover and a prefilled syringe using the same, so as to meet the antibacterial and waterproof requirements of the prefilled syringe, while not affecting the ethylene oxide gas sterilization of the needle, and allowing the syringe to perform drug mixing operations without removing the needle protective cover.

[0005] In order to achieve the above-mentioned purpose and other related purposes, the utility model provides a needle protection cover, including a cover body with a proximal end and a distal end of the cover body, wherein the cover body has a cavity for accommodating the needle assembly, the proximal end of the cover body is used for sealing connection with the needle seat of the prefilled syringe, and the distal end of the cover body is provided with a bacteriostatic waterproof breathable membrane, which is in communication with the cavity. The bacteriostatic waterproof breathable membrane is only breathable, and the needle can be sterilized by ethylene oxide gas. At the same time, the bacteriostatic waterproof breathable membrane can isolate liquids and bacteria, meeting the bacteriostatic and waterproof requirements of the medicine in the prefilled syringe. In addition, when mixing drugs in a double-chamber prefilled syringe, the air can be exhausted through the bacteriostatic waterproof breathable membrane, allowing the plunger to be pushed more smoothly, and effective drug mixing can be carried out without removing the needle protection cover.

[0006] Preferably, a tray is provided at the distal end of the sleeve, and a bacteria-blocking, waterproof, and breathable membrane is mounted on the tray and affixed to the tray and / or the inner wall of the distal end of the sleeve. The tray has a through hole communicating with the cavity, and the membrane covers the through hole. Positioning the membrane at the end facilitates installation and replacement, provides a more direct path for air in and out, and enhances ventilation and exhaust efficiency.

[0007] Preferably, the inner wall of the proximal end of the sleeve body is provided with a snap ring and a sealing ring. The snap ring can ensure that the needle guard is installed in place, and the sealing ring can ensure the seal between the needle guard and the needle assembly.

[0008] Preferably, the inner wall of the sleeve is provided with an axially arranged anti-rotation ridge, and the outer wall of the sleeve is provided with an axially arranged anti-slip ridge. The anti-rotation ridge ensures that the needle assembly can be rotated simultaneously with the needle guard, thereby installing the needle assembly on the needle seat. During this process, direct contact between the hand and the needle assembly is avoided, thereby preventing accidental injury from the needle. The anti-slip ridge ensures that the operator will not slip when pinching the outer wall of the needle guard to rotate it.

[0009] The prefilled syringe using the needle guard comprises a needle guard, a needle assembly, a needle holder, and a syringe. The needle assembly is connected to the needle holder, the needle holder is provided at the end of the syringe, the sleeve covers the outside of the needle assembly, the proximal end of the sleeve is tightly connected to the needle holder, and the needle tip of the needle assembly faces the antibacterial, waterproof, and breathable membrane. Thus, after the prefilled syringe is installed with the needle guard, the prefilled medicine can be prevented from contacting with external liquids and bacteria, ensuring efficacy. After the syringe is assembled and filled with medicine, ethylene oxide gas can enter through the antibacterial, waterproof, and breathable membrane, and the needle can still be sterilized with ethylene oxide gas, ensuring safety in use. The needle guard can be vented from the front end of the needle guard without removing it, and the plunger in the syringe slides smoothly, allowing for effective mixing of the medicine.

[0010] Preferably, the needle assembly is connected to the needle hub via a Luer connector. A retaining ring is provided on the outside of the Luer connector, and a snap ring is provided at the proximal end of the housing to mate with the retaining ring. When the needle shield is slipped over the outside of the needle assembly, the snap ring squeezes past the retaining ring, making a click, indicating that the needle shield is securely installed. Once securely installed, the needle shield is unlikely to fall off.

[0011] Preferably, the needle assembly is connected to the needle hub via a Luer connector, with a sealing ring positioned between the Luer connector and the proximal end of the housing. This sealing ring ensures a seal between the needle assembly and the needle shield, preventing external fluids and bacteria from entering the syringe barrel through the needle and coming into contact with the medication within, thereby affecting the efficacy of the prefilled medication.

[0012] Preferably, the needle hub is provided with a foldable sheath, which is attached to the needle hub's sleeve portion via a connecting ring. A retaining ring is provided on the outer side of the sleeve portion, and a retaining ridge is provided on the inner wall of the connecting ring to match the retaining ridge. When the foldable sheath is attached to the sleeve portion, the retaining ridge pushes past the retaining ridge, making a clicking sound, indicating that the foldable sheath is securely installed. Once securely installed, the foldable sheath is unlikely to fall off.

[0013] Preferably, a raised anti-rotation strip is provided on the sleeve portion, so as to ensure that the foldable sheath does not rotate and affect its use.

[0014] Preferably, the syringe is a dual-chamber syringe, with an infusion port located in the middle of the needle hub, connecting the syringe to the needle assembly. Furthermore, a liquid guide groove extending from the sidewall of the needle hub to the infusion port is located inside the needle hub. This allows the rear piston to squeeze the liquid medication in the syringe into the guide groove and out of the infusion port, effectively utilizing the medication and minimizing residual medication.

[0015] As described above, the needle protection cover and the prefilled syringe using the needle protection cover of the present invention have at least the following beneficial effects:

[0016] 1) The antibacterial, waterproof and breathable membrane on the needle protection cover of the utility model can isolate liquids and bacteria, meeting the antibacterial and waterproof requirements of the medicine in the pre-filled syringe.

[0017] 2) The antibacterial, waterproof and breathable membrane on the needle protection cover of the utility model is breathable. After the syringe is assembled and filled with medicine, the needle can still be sterilized with ethylene oxide gas to ensure safety in use.

[0018] 3) The double-chamber prefilled syringe using the needle guard of the utility model can exhaust air from the front end of the needle guard without removing the needle guard, thereby ensuring smooth sliding of the plunger and effective mixing of the medicine in the syringe. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Figure 1 This is a schematic diagram of the exploded three-dimensional structure of the needle protection cover of the utility model.

[0020] Figure 2 This is a schematic diagram of the exploded three-dimensional structure of the needle protection cover of the utility model from another angle.

[0021] Figure 3 This is a schematic diagram of the three-dimensional structure of the needle assembly of the present utility model.

[0022] Figure 4 It is a schematic diagram of the three-dimensional structure of the syringe of the utility model.

[0023] Figure 5 It is a schematic diagram of the three-dimensional structure of the foldable sheath of the syringe of the utility model when it is unfolded.

[0024] Figure 6 This is a schematic diagram of the cross-sectional structure of the foldable sheath of the syringe of the utility model when it is not unfolded.

[0025] Figure 7 This is a schematic diagram of the explosive decomposition structure of the syringe of the utility model.

[0026] Figure 8 This is a schematic diagram of the three-dimensional structure of the foldable protective cover of the utility model when it is not unfolded.

[0027] Figure 9 It is a schematic diagram of the three-dimensional structure of the needle seat of the utility model.

[0028] Figure 10 This is a schematic diagram of the three-dimensional structure of the needle holder of the present invention from another angle.

[0029] Description of reference numerals:

[0030] Sleeve body 1, sleeve proximal end 11, sleeve distal end 12, tray 13, through hole 131, anti-slip ridge 14, anti-rotation ridge 15, cavity 16, snap ring 17, sealing ring 18, antibacterial waterproof breathable membrane 2, needle assembly 3, Luer connector 31, positioning ring 311, folding sheath 4, connecting ring 41, limiting ridge 411, needle seat 5, sleeve connecting portion 51, limiting ridge 52, infusion hole 53, liquid guide groove 54, injection barrel 6. DETAILED DESCRIPTION

[0031] The following describes the implementation of the present invention through specific embodiments. People familiar with this technology can easily understand other advantages and effects of the present invention from the contents disclosed in this specification.

[0032] It should be noted that the structures, proportions, sizes, etc. illustrated in the drawings of this specification are only used to match the contents disclosed in the specification for understanding and reading by those familiar with this technology, and are not used to limit the conditions for implementation of the present invention. Therefore, they have no substantial technical significance. Any modification of the structure, change in the proportional relationship, or adjustment of the size should still fall within the scope of the technical content disclosed in the present invention without affecting the efficacy and purpose of the present invention. At the same time, terms such as "upper", "lower", "left", "right", "middle" and "one" quoted in this specification are only for the convenience of description and are not used to limit the scope of implementation of the present invention. Changes or adjustments in their relative relationships should also be considered as the scope of implementation of the present invention without substantially changing the technical content.

[0033] Example 1: Figure 1 、 Figure 2 As shown, the needle protection sleeve of the present invention is integrally injection-molded and includes a sleeve body 1 having a proximal end 11 and a distal end 12. The sleeve body 1 defines a cavity 16 for accommodating the needle assembly 3. The proximal end 11 is configured to be sealedly connected to the needle hub 5 of a prefilled syringe. The distal end 12 of the sleeve is provided with a tray 13, which is injection-molded onto the inner wall of the sleeve body 1 and integrally connected to the sleeve body 1. A bacteria-resistant, waterproof, and breathable membrane 2 is provided on the outer side of the tray 13 and is secured to the tray 13 and / or the inner wall of the distal end 12 of the sleeve. The membrane 2 can be secured to the inner wall of the distal end 12 of the sleeve by ultrasonic welding, by adhesive bonding, or by both the inner wall of the distal end 12 of the sleeve and the tray 13. The tray 13 defines a through hole 131 communicating with the cavity 16, and the through hole 131 is covered by the bacteria-resistant, waterproof, and breathable membrane 2. In this way, the outside world can only communicate with cavity 16 through the antibacterial, waterproof, and breathable membrane 2. The antibacterial, waterproof, and breathable membrane 2 is impermeable to liquids and bacteria, but permeable to gases. Such breathable membranes are known in the art and readily available commercially, so they will not be described in detail here. A retaining ring 17 and a sealing ring 18 are provided on the inner wall of the proximal end 11 of the sleeve. Axially disposed anti-rotation ribs 15 are provided on the inner wall of the sleeve 1, and axially disposed anti-slip ribs 14 are provided on the outer wall of the sleeve 1. Multiple retaining rings 17, sealing rings 18, anti-slip ribs 14, and anti-rotation ribs 15 may be provided, the number of which depends on the specific situation.

[0034] like Figure 3As shown, the sidewall shape of the Luer connector 31 of the needle assembly 3 matches the outer wall of the proximal end 11 of the sleeve, ensuring a snug fit when the two are inserted. When properly inserted, the retaining ring 17 utilizes the elastic deformation of the plastic to squeeze through the retaining ring 311 and seat inside it, emitting a click to indicate when in place. The retaining ring 311 restrains the retaining ring 17, preventing the needle guard from falling off. The sealing ring 18 ensures a tight seal between the Luer connector 31 and the proximal end 11 of the sleeve, isolating them from external impurities and preventing them from passing through.

[0035] After the needle shield is attached to the needle assembly 3, pinch the outer edge of the needle shield, align the Luer connector 31 with the female Luer connector of the needle hub 5, and rotate it to install the needle shield and needle assembly 3 together on the needle hub 5, maintaining a sealed connection. This is prior art and will not be described in detail here. The anti-rotation ridge 15 ensures that the needle shield rotates with the needle assembly 3 without slipping. The anti-slip ridge 14 facilitates manual rotation of the sleeve body 1.

[0036] The needle protection cover of the utility model is easy to manufacture and has good use effect.

[0037] Example 2: Figures 4-10 As shown, this prefilled syringe using the aforementioned needle shield comprises a needle shield, a needle assembly 3, a needle hub 5, and a syringe 6. The needle assembly 3 is connected to the needle hub 5, which is located at the end of the syringe 6. The sleeve 1 covers the outer surface of the needle assembly 3, with the sleeve proximal end 11 hermetically connected to the needle hub 5. The needle tip of the needle assembly 3 faces the antibacterial, waterproof, breathable membrane 2. The needle assembly 3 is connected to the needle hub 5 via a Luer connector 31. A retaining ring 311 is provided on the outer surface of the Luer connector 31, and a retaining ring 17 is provided at the proximal end 11 of the sleeve that mates with the retaining ring 311. The needle assembly 3 is connected to the needle hub 5 via the Luer connector 31, with a sealing ring 18 provided between the Luer connector 31 and the proximal end 11 of the sleeve.

[0038] like Figure 8 As shown, the needle hub 5 is provided with a folding sheath 4. The folding sheath 4 is a prior art, and its basic structure is consistent with that disclosed in Chinese patent application CN1674951A, so it will not be described in detail here. The folding sheath 4 is connected to the sleeve portion 51 of the needle hub 5 via a connecting ring 41. A limiting protrusion 52 is provided on the outer side of the sleeve portion 51; the inner wall of the connecting ring 41 is provided with a limiting ridge 411 that matches the limiting protrusion 52. The limiting ridge 411 can be provided with an inclined surface to facilitate the sliding of the limiting protrusion 52. A raised anti-rotation strip 511 is provided on the sleeve portion 51. The anti-rotation strip 511 can be provided with an inclined surface to facilitate the sliding of the inner wall of the connecting ring 41, so that the connecting ring 41 and the sleeve portion 51 are locked and prevented from rotating.

[0039] The syringe 6 is a dual-chamber syringe, which is known in the art and will not be described in detail here. Its basic structure is shown in Chinese Patent CN201020655107.7. A fluid infusion port 53 is located in the center of the needle hub 5, connecting the syringe 6 to the needle assembly 3. Inside the needle hub 5, a fluid guide groove 54 extends from the sidewall to the fluid infusion port 53. Even after the front piston is pushed to the bottom, the liquid in the syringe can still be ejected through the fluid guide groove 54 by the rear piston.

[0040] like Figures 4 to 7 As shown, after the needle guard of the utility model is installed on the syringe, it can isolate liquids and bacteria, prevent them from contacting the pre-filled medicine in the syringe, and ensure the efficacy of internal biological medicines. At the same time, gas can still pass through the needle guard, so as not to affect the sterilization of the needle using ethylene oxide gas. When the syringe is a double-chamber syringe, the plunger can be pushed without removing the needle guard to mix the medicines in the double-chamber injection chamber in the barrel. The gas to be discharged from the barrel during the mixing process is discharged from the front end of the needle guard, thereby ensuring the smooth mixing of the medicines. At the same time, since the needle guard is not removed during the entire process of mixing the medicines, it can be ensured that the medicine in the barrel will not come into contact with external liquids and bacteria before injection, thereby affecting the efficacy of the medicines.

[0041] During injection, the needle protection cover is removed and the syringe of the utility model can be used to complete the injection. After the injection is completed, the base of the foldable cover 4 is pushed with the thumb, and the foldable cover 4 is unfolded to cover the used metal needle, preventing accidental puncture by the metal needle. At the same time, the syringe can be used once and will not be reused to cause medical contamination.

[0042] In summary, the present invention effectively overcomes various shortcomings of the prior art and has industrial application value.

[0043] The above embodiments are merely illustrative of the principles and effects of the present invention and are not intended to limit the present invention. Anyone skilled in the art may modify or alter the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or alterations made by one of ordinary skill in the art without departing from the spirit and technical principles disclosed in the present invention are intended to be covered by the claims of the present invention.

Claims

1. A needle protection sleeve, comprising a sleeve body (1) with a sleeve body proximal end (11) and a sleeve body distal end (12), wherein the sleeve body (1) has a cavity (16) for accommodating a needle assembly (3), characterized in that: The proximal end (11) of the sleeve is used for sealed connection with the needle seat (5) of the prefilled syringe, and the distal end (12) of the sleeve is provided with a bacteria-proof, waterproof and breathable membrane (2), which is in communication with the cavity (16).

2. The needle protection cover according to claim 1, characterized in that: The distal end (12) of the sleeve body is provided with a tray (13), the antibacterial waterproof breathable membrane (2) is provided on the tray (13), and the antibacterial waterproof breathable membrane (2) is fixed to the tray (13) and / or the inner wall of the distal end (12) of the sleeve body; the tray (13) is provided with a through hole (131) communicating with the cavity (16), and the antibacterial waterproof breathable membrane (2) covers the through hole (131).

3. The needle protection cover according to claim 1, characterized in that: The inner wall of the proximal end (11) of the sleeve body is provided with a clamping ring (17) and a sealing ring (18).

4. The needle protection cover according to claim 1, characterized in that: The inner wall of the sleeve body (1) is provided with an axially arranged anti-rotation ridge (15); and the outer wall of the sleeve body (1) is provided with an axially arranged anti-slip ridge (14).

5. A prefilled syringe using the needle protection sleeve according to any one of claims 1 to 4, comprising a needle protection sleeve, a needle assembly (3), a needle seat (5), and a syringe (6), wherein the needle assembly (3) is connected to the needle seat (5), and the needle seat (5) is arranged at the end of the syringe (6), characterized in that: The sleeve (1) covers the outside of the needle assembly (3), the proximal end (11) of the sleeve is tightly connected to the needle seat (5), and the needle tip of the needle assembly (3) faces the antibacterial, waterproof and breathable membrane (2).

6. The prefilled syringe according to claim 5, characterized in that: The needle assembly (3) is connected to the needle seat (5) via a Luer connector (31). A positioning ring (311) is provided on the outside of the Luer connector (31), and a clamping ring (17) that matches the positioning ring (311) is provided at the proximal end of the sleeve (11).

7. The prefilled syringe according to claim 5, characterized in that: The needle assembly (3) is connected to the needle seat (5) via a Luer connector (31), and a sealing ring (18) is provided between the Luer connector (31) and the proximal end (11) of the sleeve body.

8. The prefilled syringe according to claim 5, characterized in that: The needle seat (5) is provided with a folding sheath (4), which is sleeved on a sleeve portion (51) of the needle seat (5) via a connecting ring (41), and a limiting convex ring (52) is provided on the outer side of the sleeve portion (51); and a limiting convex ridge (411) matching the limiting convex ring (52) is provided on the inner wall of the connecting ring (41).

9. The prefilled syringe according to claim 8, characterized in that: A raised anti-rotation strip (511) is provided on the sleeve portion (51).

10. The prefilled syringe according to claim 5, characterized in that: The syringe (6) is a double-chamber syringe, and an infusion hole (53) for connecting the syringe (6) with the needle assembly (3) is provided in the middle of the needle seat (5), and a liquid guide groove (54) is provided on the inner side of the needle seat (5) and leads from the side wall to the infusion hole (53).

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