Needle head for pre-filling needle, pre-filling needle and injector
By optimizing the design of the pre-filled needle with side holes, the diffusion area of the drug solution is increased, which solves the problems of large injection force and pain when injecting high-viscosity drugs, and enables subcutaneous injection of drugs with higher viscosity, reducing the difficulty of injection and pain.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-12-20
- Publication Date
- 2026-04-07
AI Technical Summary
Existing manual syringes and safety pre-filled needles have problems such as high injection force, difficulty in injection, and increased pain when injecting high-viscosity drugs, and they are difficult to meet the needs of long-term and frequent subcutaneous injections.
Design a pre-filled needle with a needle tip and a liquid outlet at the end, and two to four side holes on the side wall. The position and diameter of the side holes are optimized to increase the diffusion area of the liquid and reduce the injection force. The structural strength of the needle is ensured by reasonably arranging the position of the side holes.
It expands the diffusion area of the drug solution during injection, reduces the injection force, reduces the difficulty of injection, is suitable for subcutaneous injection of drugs with higher viscosity, reduces patient pain, and maintains the structural strength of the needle.
Smart Images
Figure CN224085770U_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The utility model relates to medical instrument technical field especially, it relates to a needle for pre-filled syringe, pre-filled syringe and syringe. BACKGROUND
[0002] Subcutaneous injection is a commonly used administration route, especially for conditions requiring long-term and frequent treatment. Long-term and frequent treatment requires patients to frequently visit medical centers, which is inconvenient for medical staff and patients, and increases the treatment time cost and expense of patients. Manual injectors and safety pre-filled syringes have the advantages of accurate administration dose, simple operation and safe use, and therefore are increasingly used as marketed product dosage forms for subcutaneous injection drugs.
[0003] Although manual injectors and safety pre-filled syringes have many advantages, their development is limited by some factors. First, the injection volume of subcutaneous injection is generally limited to 2 mL or less, and due to the demand for biological drug doses, high-concentration protein preparations have emerged, which in turn have resulted in the problem of high viscosity of the drug solution. However, the inner packaging material and injection assembly of manual injectors and safety pre-filled syringes are pre-filled syringes, and the needle is a narrow-aperture stainless steel needle with only one liquid outlet at the tip. Injecting high-viscosity drug solution through a narrow-aperture needle will generate high injection force, making injection difficult or even incomplete. On the other hand, using a larger-aperture needle will increase the pain felt by the patient and reduce the drug use compliance.
[0004] Therefore, there is an urgent need to provide a needle for pre-filled syringe, a pre-filled syringe and a syringe to solve the above problems. SUMMARY
[0005] The first object of the utility model is to provide a needle for pre-filled syringe, which can enlarge the diffusion area of the drug solution, reduce the injection force and lower the injection difficulty during the injection process, so that it can be used for subcutaneous injection of larger viscosity drug solution and can ensure the structural strength of the needle.
[0006] The second object of the utility model is to provide a pre-filled syringe, which can enlarge the diffusion area of the drug solution, reduce the injection force and lower the injection difficulty during the injection process by using the above-mentioned needle for pre-filled syringe, so that it can be used for subcutaneous injection of larger viscosity drug solution.
[0007] The third object of the utility model is to provide a syringe, which can enlarge the diffusion area of the drug solution, reduce the injection force and lower the injection difficulty during the injection process by using the above-mentioned pre-filled syringe, so that it can be used for subcutaneous injection of larger viscosity drug solution.
[0008] To achieve this object, the utility model adopts the following technical solutions:
[0009] A needle for a pre-filled syringe, the needle has a tip and a liquid outlet at the end of the needle, two to four side holes are arranged on the side wall of the needle at a certain distance along the length direction of the needle and are communicated with the liquid outlet, the side hole farthest from the tip is defined as the first side hole, the side hole closest to the tip is defined as the second side hole, the distance between the distal end edge of the first side hole and the tip is less than or equal to 6.0mm, and the distance between the proximal end edge of the second side hole and the tip is greater than or equal to 3.0mm.
[0010] As an optional solution, the aperture of the side hole is 0.2-0.25mm.
[0011] As an optional solution, the distance between the distal end edge of the first side hole and the tip is less than or equal to 5mm.
[0012] As an optional solution, the needle is a 27G needle, two side holes are arranged on the side wall of the needle along the length direction of the needle, and the distance between the centers of the two side holes is 1.3-1.9mm.
[0013] As an optional solution, the distance between the centers of the two side holes is 1.5-1.7mm.
[0014] As an optional solution, the distance between the proximal end edge of the second side hole and the tip is 3.3±0.1mm.
[0015] As an optional solution, the aperture of the side hole is 0.2mm.
[0016] As an optional solution, each side hole is located on the same side of the needle, and the connecting line between the centers of the side holes is parallel to the axis of the needle.
[0017] Alternatively, each side hole is located on a different side of the needle, and adjacent two side holes have an included angle on the circumference.
[0018] A pre-filled syringe comprising the needle for a pre-filled syringe.
[0019] A syringe comprising the pre-filled syringe.
[0020] The beneficial effects of the utility model are as follows:
[0021] The utility model provides a pre -filling needle is used needle, is used for hypodermic injection, through the liquid outlet of needle tip and two to four side holes on the lateral wall, all can carry out medicine injection, compared with prior art ordinary pre -filling needle, can enlarge the diffusion area of liquid medicine in the injection process, reduces the injection force, reduces the injection difficulty, thereby can be used for the hypodermic injection of larger viscosity liquid medicine, and need not use larger aperture needle, thereby alleviate the pain feeling of patient when hypodermic injection. In addition, two to four side holes arrange according to certain distance, the distance of the distal end edge of first side hole from needle tip is less than or equal to 6mm, the distance of the proximal end edge of second side hole from needle tip is greater than or equal to 3mm, therefore through the reasonable arrangement of the position of multiple side holes, can guarantee the structural strength of needle while opening the hole.
[0022] The utility model also provides a pre -filling needle, through the pre -filling needle of above, can enlarge the diffusion area of liquid medicine in the injection process, reduces the injection force, reduces the injection difficulty, thereby can be used for the hypodermic injection of larger viscosity liquid medicine.
[0023] The utility model also provides a syringe, through the pre -filling needle of above, can enlarge the diffusion area of liquid medicine in the injection process, reduces the injection force, reduces the injection difficulty, thereby can be used for the hypodermic injection of larger viscosity liquid medicine. ACCURACY OF DRAWINGS
[0024] Figure 1 It is the structure schematic of needle provided in the first optional embodiment of the utility model Figure 1 ;
[0025] Figure 2 It is the structure schematic of needle provided in the first optional embodiment of the utility model Figure 2 ;
[0026] Figure 3 It is the structure schematic of needle provided in the first optional embodiment of the utility model
[0027] Figure 4 It is the structure schematic of needle provided in the second optional embodiment of the utility model Figure 1 ;
[0028] Figure 2 It is the structure schematic of needle provided in the second optional embodiment of the utility model Figure 6 ;
[0029] Figure 7 It is the structure schematic of needle provided in the third optional embodiment of the utility model
[0030] Figure 1 It is the structure schematic of pre -filling needle provided by the utility model.
[0031] Fig. 1 is a schematic view of a conventional syringe.
[0032] 10, needle; 11, needle tip; 12, liquid outlet; 13, side hole; 131, first side hole; 132, second side hole; 20, barrel; 30, rubber plug; 40, cap. DETAILED DESCRIPTION
[0033] The utility model will be described in further detail below in connection with the drawings and embodiments. It can be understood that the specific embodiments described herein are merely intended to explain the utility model, but not to limit the utility model. In addition, it should be noted that only the parts related to the utility model are shown in the drawings for the convenience of description, not all the structures.
[0034] In the description of the utility model, unless otherwise explicitly specified and limited, the terms "connected", "connected", "fixed" should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or it can be integrated; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the internal communication of two elements or the interaction relationship between two elements. For ordinary skilled in the art, the specific meaning of the above terms in the utility model can be understood according to the specific circumstances.
[0035] In the utility model, unless otherwise explicitly specified and limited, the "upper" or "lower" of the first feature to the second feature can include that the first and second features are in direct contact, or the first and second features are not in direct contact but are in contact through another feature between them. Moreover, the "upper", "upper" and "upper" of the first feature to the second feature include that the first feature is directly above and obliquely above the second feature, or only indicates that the horizontal height of the first feature is higher than that of the second feature. The "lower", "lower" and "lower" of the first feature to the second feature include that the first feature is directly below and obliquely below the second feature, or only indicates that the horizontal height of the first feature is less than that of the second feature.
[0036] In the description of the embodiment, the terms "upper", "lower", "right", etc. orientation or position relationship is based on the orientation or position relationship shown in the drawings, only for the convenience of description and simplification of operation, and does not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation, therefore it cannot be understood as a limitation on the utility model. In addition, the terms "first" and "second" are only used to distinguish in the description, and have no special meaning.
[0037] As Figure 1As shown, the embodiment provides a needle 10 for pre-filled syringe, which is used for subcutaneous injection. The needle 10 has a tip 11 and a liquid outlet 12 at the end of the needle 10. Two to four side holes 13 are arranged on the side wall of the needle 10 at a certain distance along the length direction of the needle 10 and are in communication with the liquid outlet 12. The side hole 13 farthest from the tip 11 is defined as the first side hole 131, and the side hole 13 closest to the tip 11 is defined as the second side hole 132. The distance between the distal edge of the first side hole 131 and the tip 11 is less than or equal to 6.0 mm, and the distance between the proximal edge of the second side hole 132 and the tip 11 is greater than or equal to 3.0 mm. Wherein, "distal" and "proximal" are relative to the tip 11. "Distal" refers to the end far from the tip 11, and "proximal" refers to the end close to the tip 11. That is, "the distal edge of the first side hole 131" refers to the edge of the first side hole 131 far from the tip 11, and "the proximal edge of the second side hole 132" refers to the edge of the second side hole 132 close to the tip 11.
[0038] The needle 10 provided by the embodiment can be used for drug injection through the liquid outlet 12 at the tip 11 and the two to four side holes 13 on the side wall. The liquid droplets at the liquid outlet 12 drop downward, and the liquid at the side hole 13 flies obliquely downward. The liquid outlet directions of the side hole 13 and the liquid outlet 12 are different, so that the drug liquid can be discharged in different directions. In the injection process, the diffusion area of the drug liquid can be expanded, the injection force can be reduced, and the injection difficulty can be reduced. Therefore, the needle 10 can be used for subcutaneous injection of drug liquid with larger viscosity, and a needle 10 with a larger aperture does not need to be used, so that the pain of the patient during subcutaneous injection is reduced. In addition, the two to four side holes 13 are arranged at a certain distance, the distance between the distal edge of the first side hole 131 and the tip 11 is less than or equal to 6.0 mm, and the distance between the proximal edge of the second side hole 132 and the tip 11 is greater than or equal to 3.0 mm. Therefore, by reasonably setting the positions of the multiple side holes 13, the structural strength of the needle 10 can be ensured while the holes are opened, and deformation or breakage of the needle 10 during injection can be avoided.
[0039] In an optional embodiment, the aperture of the side hole 13 is 0.2-0.25 mm, which can ensure the structural strength of the needle 10. For example, the aperture of the side hole 13 can be 0.2 mm, 0.21 mm, 0.22 mm, 0.23 mm, 0.24 mm or 0.25 mm. The aperture of the side hole 13 can be adaptively selected according to the size of the needle 10.
[0040] In this embodiment, the needle 10 can be a 27G needle with a length of 12.7mm. The 27G needle is relatively thin, which can reduce the patient's pain during subcutaneous injection, meeting the mainstream needs of current subcutaneous formulation development. For the 27G needle, due to its thinner wall thickness, only two side holes 13 need to be formed along its length on the sidewall of the needle 10, namely a first side hole 131 and a second side hole 132. The center-to-center distance between the two side holes 13 is 1.3-1.9mm to ensure the structural strength of the needle 10. In other optional embodiments, the needle 10 can also be a 25G needle or a 23G needle.
[0041] More preferably, the center-to-center distance between the two side holes 13 is 1.5-1.7 mm to further ensure the structural strength of the needle 10. For example, the center-to-center distance between the two side holes 13 can be 1.5 mm, 1.6 mm, or 1.7 mm.
[0042] For a specific injection method, such as pinch injection, the subcutaneous injection depth is 8.0 mm. Therefore, the maximum distance between the distal edge of the first side hole 131 and the needle tip 11 can reach 6.0 mm. For vertical injection, the subcutaneous injection depth is smaller than that of pinch injection. In this case, the distance between the distal edge of the first side hole 131 and the needle tip 11 is less than or equal to 5.0 mm, so as to ensure that the side hole 13 is completely located inside the skin during subcutaneous injection.
[0043] Furthermore, the distance between the proximal edge of the second side hole 132 and the needle tip 11 is preferably 3.3 ± 0.1 mm. For example, the distance between the proximal edge of the second side hole 132 and the needle tip 11 can be 3.2 mm, 3.3 mm, or 3.4 mm, so as not to affect the structural strength of the beveled surface of the needle tip 10.
[0044] For 27G needles, due to the thinner wall thickness, the diameter of the side hole 13 is preferably 0.2mm. For 25G or 23G needles, due to the increased wall thickness, the diameter of the side hole 13 can be increased more flexibly, as long as it remains within the range of 0.2-0.25mm. This ensures the structural strength of various needle models 10 and prevents needle breakage.
[0045] In one optional embodiment, Figure 6 As shown, all side holes 13 are located on the same side of the needle 10. That is, the line connecting the centers of all side holes 13 is parallel to the axis of the needle 10, and the liquid outlet direction of all side holes 13 is the same. For example, two side holes 13 can be located on the front side of the beveled surface of the needle 10, or on the back side of the beveled surface of the needle 10, or at any position on the side of the needle 10, as long as the two side holes 13 are on the same side.
[0046] In another alternative embodiment, such as Figure 3 As shown, each side hole 13 is located on a different side of the needle 10. That is, two adjacent side holes 13 have an included angle on the circumference, and the included angle can be arbitrary, such as 180°, 150° or 120°. In this way, the liquid outlet direction of each side hole 13 is different, which can increase the liquid outlet direction, further expand the drug diffusion area, reduce the injection force, and reduce the difficulty of injection.
[0047] To this end, the inventors conducted comparative experiments on the needle 10 of this application and a conventional needle. Specifically, in this embodiment, the needle 10 has two side holes 13 located on the same side. The diameter of the first side hole 131 is 0.21 mm, and the diameter of the second side hole 132 is 0.22 mm. The distal edge of the first side hole 131 is 4.95 mm from the needle tip 11, and the proximal edge of the second side hole 132 is 3.0 mm from the needle tip 11. The center-to-center distance between the two side holes 13 is 1.7 mm. In contrast, a conventional needle only has one outlet 12 extending through to the needle tip 11. High-viscosity drugs were simulated using solutions with viscosities of 20 cP and 40 cP (25°C), respectively. The drug injection process was simulated using an Instron instrument at injection speeds of 400 mm / min and 200 mm / min, respectively.
[0048] like Figure 1 The test results show that when injecting 20 cP solution at a speed of 400 mm / min, the average sliding force of the pre-filled needle using the needle 10 of this application is 48.2 ± 1.56 N, while the average sliding force of the pre-filled needle using a conventional needle is 53.9 ± 0.65 N. When injecting 40 cP solution at a speed of 200 mm / min, the average sliding force of the pre-filled needle using the needle 10 of this application is 42.4 ± 1.39 N, while the average sliding force of the pre-filled needle using a conventional needle is 48.9 ± 0.61 N. It is evident that the average sliding force of the pre-filled needle using the needle 10 of this application is lower than that of the pre-filled needle using a conventional needle. This demonstrates that using the needle 10 of this application can significantly reduce the injection resistance during subcutaneous injection and reduce the difficulty of injection.
[0049] For example, the following section will describe in detail several different needles 10, using the 27G needle as an example.
[0050] In the first implementation method, such as Figure 2 and Figure 4 As shown, both side holes 13 are located on the front of the oblique section of the needle tip 10. The diameter of the first side hole 131 and the second side hole 132 is 0.2 mm. The distal edge of the first side hole 131 is 5.0 mm away from the needle tip 11, and the proximal edge of the second side hole 132 is 3.0 mm away from the needle tip 11. The center-to-center distance between the two side holes 13 is 1.5 mm.
[0051] In the second implementation method, such as Figure 5 and Figure 6 As shown, both side holes 13 are located on the back side of the oblique section of the needle tip 10. The diameter of the first side hole 131 and the second side hole 132 is 0.2 mm. The distal edge of the first side hole 131 is 5.0 mm away from the needle tip 11, and the proximal edge of the second side hole 132 is 3.2 mm away from the needle tip 11. The center-to-center distance between the two side holes 13 is 1.6 mm.
[0052] In the third implementation method, such as Figure 7 As shown, the two side holes 13 are located on different sides of the needle tip 10, and the included angle between the two side holes 13 on the circumference is 180°. The diameter of the first side hole 131 and the second side hole 132 is 0.2 mm. The distal edge of the first side hole 131 is 5.0 mm away from the needle tip 11, and the proximal edge of the second side hole 132 is 3.3 mm away from the needle tip 11. The center-to-center distance between the two side holes 13 is 1.5 mm. Of course, in other embodiments, the included angle between the two side holes 13 on the circumference can also be 120°, 150°, etc., and this application does not make specific limitations.
[0053] like As shown, this embodiment also provides a pre-filled needle, which includes a syringe 20, a rubber stopper 30, a protective cap 40, and the aforementioned pre-filled needle 10. One end of the needle 10 is inserted into the end of the syringe 20. The syringe 20 can be pre-filled with medication. The rubber stopper 30 is interference-fitted into the syringe 20 to seal the medication inside the syringe 20. The protective cap 40 is fastened to the end of the syringe 20 and covers the needle 10 to protect the needle 10.
[0054] The pre-filled needle provided in this embodiment, by using the pre-filled needle 10 described above, can expand the diffusion area of the drug solution during injection, reduce the injection force, and reduce the difficulty of injection, thereby enabling it to be used for subcutaneous injection of drugs with higher viscosity.
[0055] This embodiment also provides a syringe, including the pre-filled needle described above. The syringe is formed by adding some components to the pre-filled needle and is used to complete different injection processes. The syringe can be a manual syringe, a safety pre-filled needle, or an automatic injection pen. Except for the needle 10, the rest are existing technologies and will not be described in detail here.
[0056] The syringe provided in this embodiment, by using the pre-filled needle described above, can expand the diffusion area of the drug solution during injection, reduce the injection force, and reduce the difficulty of injection, thereby enabling it to be used for subcutaneous injection of drugs with higher viscosity.
[0057] Obviously, the above embodiments of this utility model are merely examples for clearly illustrating the present utility model, and are not intended to limit the implementation of the present utility model. Those skilled in the art can make various obvious changes, readjustments, and substitutions without departing from the protection scope of this utility model. It is neither necessary nor possible to exhaustively describe all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of this utility model should be included within the protection scope of the claims of this utility model.
Claims
1. A pre-filled needle tip, characterized in that, For subcutaneous injection, the needle tip has a needle tip (11) and an outlet (12) at its end. Two to four side holes (13) communicating with the outlet (12) are opened at certain intervals along the length of the needle side wall. The side hole (13) farthest from the needle tip (11) is defined as the first side hole (131), and the side hole (13) closest to the needle tip (11) is defined as the second side hole (132). The distance between the distal edge of the first side hole (131) and the needle tip (11) is less than or equal to 6.0 mm, and the distance between the proximal edge of the second side hole (132) and the needle tip (11) is greater than or equal to 3.0 mm. The diameter of the side hole (13) is 0.2-0.25 mm.
2. The pre-filled needle tip according to claim 1, characterized in that, The distance between the distal edge of the first side hole (131) and the needle tip (11) is less than or equal to 5.0 mm.
3. The pre-filled needle tip according to claim 1, characterized in that, The needle is a 27G needle, and two side holes (13) are formed on the side wall of the needle along its length direction. The center distance between the two side holes (13) is 1.3-1.9mm.
4. The pre-filled needle tip according to claim 3, characterized in that, The center-to-center distance between the two side holes (13) is 1.5-1.7 mm.
5. The pre-filled needle tip according to claim 3, characterized in that, The distance between the proximal edge of the second side hole (132) and the needle tip (11) is 3.3 ± 0.1 mm.
6. The pre-filled needle tip according to claim 3, characterized in that, The diameter of the side hole (13) is 0.2 mm.
7. The pre-filled needle tip according to claim 1, characterized in that, Each of the side holes (13) is located on the same side of the needle tip, and the line connecting the centers of each of the side holes (13) is parallel to the axis of the needle tip. Alternatively, each of the side holes (13) is located on a different side of the needle, and two adjacent side holes (13) have an included angle on the circumference.
8. A pre-filled needle, characterized in that, Includes the pre-filled needle as described in any one of claims 1-7.
9. A syringe, characterized in that, Includes the pre-charge needle as described in claim 8.