A plunger assembly and a sterile drug delivery device and a sterile drug delivery device

Abstract

The utility model discloses a kind of compression pump assembly and sterile medicine device, including pump body, connecting piston and cover;Wherein, the connecting piston is slidably arranged in the pump body, the connecting piston includes skirt sealing section conical transition section and spray head connecting section connected in turn;The cover is fixedly arranged in the proximal end of the pump body, the inboard of the cover is respectively provided with salient angle part and arc part;And, the salient angle part and the spray head connecting section interference fit form first seal, the arc part and conical transition section interference fit form second seal.The double-sealing design of the compression pump assembly and sterile medicine device greatly improves the dynamic sealing reliability and effectiveness of connecting piston, can prevent external gas from its peripheral gap into the pump body to cause pollution to sterile liquid;The special structure design of second seal meets the operability and sealing requirement simultaneously.

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a pressure pump assembly and a sterile drug delivery device. Background Technology

[0002] Eye drops are sterile liquid preparations made from drugs and suitable excipients, intended for instillation into the eye. As sterile preparations used directly on the eye to exert therapeutic effects, their safety and quality control have always been a concern. The quality requirements for eye drops are the same in various countries as those for injectable drugs, and my country is currently moving in this direction as well.

[0003] Currently, most eye drops on the market are packaged in multi-dose packs for repeated use. Once opened, these preparations are easily contaminated by microorganisms in tears and the air during use and storage, posing safety risks. To prevent microbial contamination during repeated use after opening, most multi-dose eye drops (including antibiotics) contain antibacterial agents such as thimerosal, benzalkonium chloride, hydroxyphenylethanol, and chlorobutanol to prevent secondary microbial contamination during use. However, antibacterial agents are cytotoxic to the corneal and conjunctival epithelial cells, damaging the cornea and conjunctiva, leading to tear film instability, and consequently causing ocular surface abnormalities and affecting vision.

[0004] In recent years, the problems caused by the overuse of antibacterial agents have received increasing attention. Therefore, the trend for future development is to eliminate the addition of antibacterial agents in the formulation process of multi-dose eye drops. However, ensuring the airtightness of multi-dose eye drop packaging after opening, especially the sealing ability at the piston of the pump, has a particularly significant impact on the use and storage of the formulation.

[0005] To address the aforementioned sealing issues, this application proposes a pressure pump assembly and a sterile drug delivery device. Utility Model Content

[0006] The purpose of this invention is to provide a pump assembly and a sterile drug delivery device to solve the sealing problem at the pump piston in multi-dose eye drop packaging, prevent external air from entering and contaminating the preparation, and improve the safety and reliability of use.

[0007] The objective of this utility model is achieved through the following technical solution: A pressure pump assembly includes a pump body, a connecting piston, and a cap; wherein the connecting piston is slidably disposed within the pump body, and the connecting piston includes a skirt sealing section, a conical transition section, and a nozzle connecting section connected in sequence; the cap is fixedly disposed near the end of the pump body, and the inner side of the cap is respectively provided with a protruding corner portion and an arc-shaped portion; furthermore, the protruding corner portion interferes with the nozzle connecting section to form a first seal, and the arc-shaped portion interferes with the conical transition section to form a second seal.

[0008] In one alternative, under pumping conditions, the relative mobility between the arc-shaped portion and the conical transition section gradually increases; under suction conditions, the interference sealing capability between the arc-shaped portion and the conical transition section gradually increases.

[0009] In an alternative embodiment, the pump assembly further includes a ball bearing and a first spring; wherein the ball bearing is disposed at the inlet port of the pump body, and the first spring is disposed between the ball bearing and the skirt seal section.

[0010] In an alternative embodiment, the outer side of the cap is provided with a lower extension, and the inner wall of the lower extension is provided with a sealing rib, which is used to seal with the neck of the liquid storage bottle.

[0011] In an alternative embodiment, the cap is provided with a sealing gasket for sealing with the mouth of the liquid storage bottle.

[0012] A sterile drug delivery device, characterized in that it comprises: a grip, a nozzle, an operating part, a liquid storage bottle, and the aforementioned pump assembly; wherein, The pressure pump assembly is disposed within the grip portion; The nozzle is disposed at the proximal end of the grip and is partially connected to the pump assembly. The operating part is located at the distal end of the grip and slides therewith; The liquid storage bottle is disposed inside the operating unit and is partially connected to the pump assembly. The inside of the liquid storage bottle is provided with a soft inner bag. The aseptic drug delivery device is designed such that pressing the operating part actuates the pump assembly, causing the liquid in the reservoir to be metered and pumped to the nozzle, while preventing external gas from entering the inner bag throughout the process.

[0013] In an alternative embodiment, the nozzle includes: The outer cone has a spray hole at its proximal end; A hollow column is disposed within the outer cone and connected to the nozzle connection section. A flow channel communicating with the nozzle is formed between the hollow column and the outer cone, and a through hole is also provided on the inner wall of the hollow column.

[0014] In an alternative embodiment, an upper piston is slidably disposed within the hollow column; The upper piston has a second spring at its proximal end and abuts against the nozzle connection section at its distal end. In the non-operating state, the upper piston seals the through hole.

[0015] In an alternative embodiment, the distal end of the outer cone is provided with a guide portion, and the outer side of the cover also includes an upper extension portion, which slides in conjunction with the guide portion.

[0016] In an alternative embodiment, an inner protrusion is provided on the distal inner wall of the gripping part, and an outer protrusion is provided on the proximal inner wall of the operating part; The gripping part and the operating part are connected by inner and outer protrusions to form a sliding telescopic structure.

[0017] Compared with the prior art, the beneficial effects of this utility model include at least the following: 1. The double-seal design greatly improves the reliability and effectiveness of the dynamic seal of the connecting piston, preventing external gas from entering the pump body through its peripheral gaps and contaminating the sterile liquid.

[0018] 2. The special structural design of the second seal satisfies both operability and sealing requirements.

[0019] 3. The sealed structure combined with the flexible and deformable design of the inner bag ensures that there is no possibility of gas exchange between the inside and outside of the device, thus preventing the sterile liquid inside the bag from being contaminated. This makes it possible to administer multiple doses of liquid without adding antibacterial agents, ensuring hygiene and safety while greatly facilitating user operation.

[0020] 4. The device can dispense a fixed amount of liquid each time, improving the safety and accuracy of drug administration.

[0021] 5. The device can be used upside down, eliminating the need for an additional suction pipe for the pump assembly, thus reducing manufacturing costs. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the pump assembly of this utility model.

[0023] Figure 2 This is a schematic diagram of the aseptic drug delivery device of this utility model.

[0024] Figure 3 yes Figure 2 Axial sectional view.

[0025] Figure 4 This is a schematic diagram of the nozzle structure of this utility model.

[0026] In the diagram: 1. Grip; 11. Rib; 111. Concave corner; 12. Inner protrusion; 13. Anti-slip texture; 14. Notch; 2. Pump assembly; 21. Pump body; 22. Connecting piston; 221. Flow guide hole; 222. Skirt sealing section; 223. Conical transition section; 224. Nozzle connecting section; 23. Ball bearing; 24. First spring; 25. Upper piston; 26. Second spring; 27. Cover; 271. Upper extension; 272. Lower extension; 273. Sealing rib; 274. Protruding corner; 275. Arc-shaped part; 28. Sealing gasket; 3. Nozzle; 31. Outer cone; 311. Nozzle hole; 312. Convex ring; 313. Guide section; 32. Hollow column; 321. Through hole; 33. Flow channel; 4. Operating section; 41. Outer protrusion; 5. Liquid storage bottle; 51. Inner bag body; 6. Protective cover. Detailed Implementation

[0027] Exemplary embodiments will now be described more fully with reference to the accompanying drawings. However, these exemplary embodiments can be implemented in many forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided to make the present invention more comprehensive and complete, and to fully convey the concept of the exemplary embodiments to those skilled in the art. The same reference numerals in the drawings denote the same or similar structures, and therefore repeated descriptions of them will be omitted.

[0028] The terms used to describe position and direction in this utility model are illustrated with the accompanying drawings, but changes can be made as needed, and all such changes are included within the scope of protection of this utility model.

[0029] First, the relative positions of the components are explained: the proximal end involved in this application can be understood as the end of the component that is closer to the dripping position, and correspondingly, the distal end is the end that is farther away from the dripping position; in addition, the operating state refers to the state when the user manually presses the operating part of the device.

[0030] This invention discloses a sterile drug delivery device filled with a sterile liquid, such as eye drops. The device can deliver a measured amount of sterile droplets under manual operation, meeting the needs of multiple dosage applications.

[0031] See Figures 1 to 4 As shown, the aseptic drug delivery device mainly includes a grip 1, a pump assembly 2, a nozzle 3, an operating part 4, and a storage bottle 5; wherein, the pump assembly 2 and the storage bottle 5 are housed in the grip 1, and the nozzle 3 and the operating part 4 are respectively located at the near and far ends of the grip 1.

[0032] Specifically, the gripping part 1 is hollow inside and is equipped with a pressure pump assembly 2. For example... Figure 2 and Figure 3As shown, the gripping part 1 in this application preferably has a hollow cylindrical structure, with its proximal end being basically closed and its distal end having an opening, in order to facilitate the installation of the liquid storage bottle 5 and the patient's gripping operation.

[0033] The nozzle 3 is located at the proximal end of the grip 1 and is partially connected to the pump assembly 2. For example... Figure 3 and Figure 4 As shown, the nozzle 3 in this application includes an outer cone 31 and a hollow column 32. The outer cone is fixed to the proximal end of the grip 1 and has a spray hole 311 at its proximal end; the hollow column 32 is inserted into the outer cone 31 and a flow channel 33 is formed between the two to communicate with the spray hole 311. In addition, a through hole 321 is provided on the inner wall of the hollow column 32.

[0034] The operating part 4 is located at the distal end of the grip part 1 and slides therewith, such as Figure 2 As shown, in this application, the operating part 4 is a round cap structure with a diameter slightly smaller than that of the grip part 1, so as to accommodate the liquid storage bottle 5 and form a sliding telescopic structure with the grip part 1.

[0035] The liquid storage bottle 5 is housed within the operating section 4 and partially connected to the pump assembly 2. Through pump suction, the liquid inside the bottle can be quantitatively delivered to the nozzle 3. In this application, the liquid storage bottle 5 itself is made of a rigid material to achieve pressure transmission from the operating section 4 to the pump assembly 2, but it also has a soft inner bag 51 on its inner side, such as... Figure 3 As shown, the inner bag 51 is used to fill sterile liquid and can deform and shrink as the air pressure decreases, thereby balancing the internal and external air pressure until the sterile liquid is consumed.

[0036] The pump assembly 2 is housed within the grip portion 1, with its proximal end connected to the nozzle 3 and its distal end connected to the storage bottle 5. Figure 4As shown, the pressure pump assembly 2 in this application includes a pump body 21, a connecting piston 22, a ball bearing 23, and an upper piston 25. The pump body 21 is located inside the neck of the liquid storage bottle 5 and the two are sealed together. The connecting piston 22 is movably inserted into the pump body 21. Its proximal end (i.e., the nozzle connecting section) is sealed to the hollow column 32, and its distal end forms a sealing skirt (i.e., the skirt sealing section) that can slide and seal with the inner wall of the pump body 21. In addition, the connecting piston 22 is also provided with an axially penetrating guide hole 221 for guiding the liquid from the liquid storage bottle 5 to the nozzle 3. The ball bearing 23 is located at the liquid inlet of the pump body 21, and a first spring 24 is provided between the ball bearing 23 and the connecting piston 22 for pressing and resetting. The upper piston 25 is located near the connecting piston 22 and abuts against it. It also forms a sealing skirt that can slide and seal with the inner wall of the hollow column 32. In addition, a second spring 26 is provided near the upper piston 25 for resetting and sealing. It should be noted that, in the non-operating state, the pump assembly 2 of this application has the ball bearing 23 sealing the liquid inlet and the upper piston 25 sealing the through hole 321 to prevent external gas from entering the inner bag 51 of the liquid storage bottle 5 and to prevent contamination of the sterile liquid.

[0037] The pressure pump assembly and sterile drug delivery device of this application are designed such that: by pressing the operating part 4, the pressure pump assembly 2 is actuated, causing the liquid in the storage bottle 5 to be metered and pumped to the nozzle 3, while preventing external gas from entering the inner bag body 51 from beginning to end.

[0038] Specifically, when using the device, first, the entire device is inverted, and its nozzle 3 is aligned with the target dripping position. Then, the operating part 4 is pressed with a finger to move it toward the nozzle 3. During this process, the pressure is transmitted to the pump assembly 2 via the storage bottle 5, causing the connecting piston 22 to compress the storage space in the pump body 21 (while the first spring 24 is compressed and the ball bearing 23 seals the inlet). The sterile liquid in the pump body 21 is pressurized and flows through the guide hole 221 into the hollow column 32, overcoming the pressure of the second spring 26 and lifting the upper piston 25, exposing its sealed through hole 321. The sterile liquid enters the flow channel 33 through the through hole 321 and finally drips out quantitatively from the nozzle 311.

[0039] After the dripping is completed, the liquid pressure inside the hollow column 32 drops sharply. The upper piston 25 resets under the elastic force of the second spring 26 and reseals the through hole 321. At the same time, the user releases their finger, and the operating part 4 resets with the help of the elastic force of the first spring 24. During this process, the connecting piston 22 evacuates the liquid storage space inside the pump body 21. The sterile liquid in the storage bottle 5 pushes up the ball 23 and is pumped into the storage space, waiting for the next use. Meanwhile, the inner bag 51 gradually collapses with each use until the sterile liquid is completely consumed.

[0040] It should be noted that the aforementioned sealing structure, combined with the flexible and deformable design of the inner bag 51, ensures that there is absolutely no possibility of gas exchange between the inside and outside of the device. This prevents contamination of the sterile liquid inside the bag, making it possible to administer multiple doses of the solution without adding antibacterial agents. While ensuring hygiene and safety, this greatly simplifies user operation. Furthermore, because the device is used inverted, when pumping the sterile liquid from the inner bag 51, the pump assembly does not require an additional suction tube, resulting in lower manufacturing costs.

[0041] See Figure 3 As shown, in some embodiments, a protruding ring portion 312 is provided at the distal end of the outer cone 31. Preferably, the protruding ring portion 312 can be integrally formed with it. In addition, a plurality of ribs 11 are provided circumferentially at the inner corner of the proximal end of the grip portion 1, and the inner side of the ribs 11 is provided with a concave corner 111 for fixing the protruding ring portion 312. In this example, the ribs 11 not only strengthen the structural strength of the grip portion 1, but also serve to fix the protruding ring portion 312, which facilitates the disassembly and assembly of the outer cone 31; and the design of first molding the two independently and then assembling them effectively reduces the difficulty of overall molding.

[0042] like Figure 1 As shown, in some embodiments, the connecting piston 22 includes a skirt sealing section 222, a conical transition section 223 and a nozzle connecting section 224 connected in sequence; the pump assembly 2 also includes a cover 27 disposed near the pump body 21, wherein the inner side of the cover 27 is provided with a protruding corner portion 274 and an arc-shaped portion 275 respectively.

[0043] In this design, the protruding corner 274 and the nozzle connecting section 224 interfere with each other to form a first seal, while the arc-shaped portion 275 and the conical transition section 223 interfere with each other to form a second seal. In this example, the connecting piston 22 and the cover 27 adopt a double-seal design, which greatly improves the reliability and effectiveness of the dynamic seal and prevents external gas from entering the pump body 21 through the outer peripheral gap of the connecting piston 22 and contaminating the sterile liquid.

[0044] Especially in the second seal, the conical structure of the conical transition section 223 and the arcuate structure of the arcuate portion 275 cooperate with each other, so that the relative movement ability between the arcuate portion 275 and the conical transition section 223 gradually increases when the pump assembly 2 is in pumping state. Specifically, when the patient presses the pump, the conical transition section 223 moves towards the distal end, and its interference with the arcuate portion 275 gradually decreases. The patient can activate the pump assembly 2 without pressing hard, which helps to improve operability.

[0045] During the liquid suction state, the interference sealing capability of the arc-shaped portion 275 and the conical transition section 223 gradually increases. Specifically, as the liquid storage space gradually forms a negative pressure environment, the conical transition section 223 moves towards the proximal end, and its interference with the arc-shaped portion 275 gradually increases, resulting in a gradual enhancement of the performance of the second seal, thereby preventing external gas from being drawn into the pump body 1 after breaking through the first seal.

[0046] As shown in Figure 1, in some embodiments, a sealing gasket 28 is provided inside the cap 27. The sealing gasket 28 is used to seal the mouth of the liquid storage bottle 5 to prevent external gas from directly entering the inner bag 51 and contaminating the sterile liquid.

[0047] Furthermore, the cap 27 also includes a lower extension 272, and a sealing rib 273 is provided on the inner wall of the lower extension 272. The sealing rib 273 is used to seal with the neck of the liquid storage bottle 5, thereby forming a pre-seal to improve the sealing performance between the cap 27 and the liquid storage bottle 5.

[0048] In addition, a guide portion 313 is provided at the distal end of the outer cone 31, which can be integrally formed with it. Furthermore, the cover 27 includes an upper extension 271, which is used to slide with the guide portion 313 to improve the stability of the pump assembly 2 during the pressing process.

[0049] See Figure 3 As shown, in some embodiments, an inner protrusion 12 is provided on the distal inner wall of the gripping part 1, and an outer protrusion 41 is provided on the proximal inner wall of the operating part 4. In this example, the inner and outer protrusions 12 and 41 are circumferentially continuous. The inner protrusion 12 abuts against the outer peripheral surface of the operating part 4, and the outer protrusion 41 abuts against the inner peripheral surface of the gripping part 1. The gripping part 1 and the operating part 4 are engaged by the inner and outer protrusions 12 and 41 to form a sliding telescopic structure.

[0050] See Figure 2 As shown, in some embodiments, the proximal end of the grip portion 1 is provided with anti-slip texture 13 and / or notch 14 to increase the friction between the fingers and the proximal end of the grip portion 1, making it easier to press. In addition, the notch 14 is also used to check whether the convex ring portion 312 of the outer cone 31 is installed in place, facilitating assembly operations.

[0051] In some embodiments, the sides of the liquid storage bottle 5 and the grip 1 are transparent to allow the user to observe the remaining liquid level in the device in real time, thus facilitating use. As an example, the liquid storage bottle 5 may be made of rigid transparent materials such as PC, PMMA, or glass, the inner bag 51 may be made of flexible transparent materials such as TPE, PVC, or PP, and the side of the grip 1 may be integrally formed with a transparent viewing window (not shown).

[0052] In some embodiments, the nozzle 3 is provided with a removable protective sleeve 6, which is used to prevent dust and impurities from entering the nozzle 311 and affecting its use or contaminating sterile liquids. In this example, the protective sleeve 6 and the outer cone 31 can be connected by an interference fit, and the inner top of the protective sleeve 6 is provided with a plug that can extend into the nozzle 311.

[0053] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make changes, modifications, substitutions and alterations to the above embodiments within the scope of the present invention without departing from the principles and spirit of the present invention, and all such changes should fall within the protection scope of the claims of the present invention.

Claims

1. A pressure pump assembly, characterized in that, include: Pump body (21); A connecting piston (22) is slidably disposed within the pump body (21). The connecting piston (22) includes a skirt sealing section (222), a conical transition section (223), and a nozzle connecting section (224) connected in sequence. A cover (27) is fixedly installed at the near end of the pump body (21), and the inner side of the cover (27) is provided with a protruding corner (274) and an arc-shaped part (275). The protruding corner portion (274) and the nozzle connecting section (224) interfere with each other to form a first seal, and the arc-shaped portion (275) and the conical transition section (223) interfere with each other to form a second seal.

2. The pump assembly according to claim 1, characterized in that, In the pumping state, the relative movement capability between the arc-shaped part (275) and the conical transition section (223) gradually increases; in the suction state, the interference sealing capability between the arc-shaped part (275) and the conical transition section (223) gradually increases.

3. The pump assembly according to claim 1, characterized in that, The pump assembly (2) further includes a ball (23) and a first spring (24); wherein the ball (23) is disposed at the liquid inlet of the pump body (21), and the first spring (24) is disposed between the ball (23) and the skirt sealing section (222).

4. The pump assembly according to claim 1, characterized in that, The outer side of the cap (27) is provided with a lower extension (272), and the inner wall of the lower extension (272) is provided with a sealing rib (273), which is used to seal with the neck of the liquid storage bottle (5).

5. The pump assembly according to claim 1, characterized in that, The cap (27) is provided with a sealing gasket (28), which is used to seal the mouth of the liquid storage bottle (5).

6. A sterile drug delivery device, characterized in that, include: The grip (1), nozzle (3), operating part (4), liquid storage bottle (5), and pump assembly (2) as described in any one of claims 1-5; wherein, The pressure pump assembly (2) is disposed within the gripping part (1); The nozzle (3) is disposed at the proximal end of the grip (1) and is partially connected to the pump assembly (2); The operating part (4) is disposed at the distal end of the gripping part (1) and slides therewith; The liquid storage bottle (5) is disposed inside the operation unit (4) and is partially connected to the pump assembly (2). The liquid storage bottle (5) has a soft inner bag (51) inside. The sterile drug delivery device is designed such that by pressing the operating part (4), the pump assembly (2) is activated, causing the liquid in the storage bottle (5) to be metered and pumped to the nozzle (3), while preventing external gas from entering the inner bag (51) from beginning to end.

7. The aseptic drug delivery device according to claim 6, characterized in that, The nozzle (3) includes: The outer cone (31) has a nozzle (311) at its proximal end. A hollow column (32) is disposed inside the outer cone (31) and connected to the nozzle connecting section (224). A flow channel (33) communicating with the nozzle (311) is formed between the hollow column (32) and the outer cone (31), and a through hole (321) is also provided on the inner wall of the hollow column (32).

8. The aseptic drug delivery device according to claim 7, characterized in that, An upper piston (25) is slidably disposed inside the hollow column (32); The upper piston (25) is provided with a second spring (26) at its proximal end and abuts against the nozzle connection section (224) at its distal end. In the non-operating state, the upper piston (25) seals the through hole (321).

9. The aseptic drug delivery device according to claim 7, characterized in that, The distal end of the outer cone (31) is provided with a guide portion (313), and the outer side of the cover (27) also includes an upper extension portion (271), which slides in cooperation with the guide portion (313).

10. The aseptic drug delivery device according to claim 6, characterized in that, An inner protrusion (12) is provided on the distal inner wall of the gripping part (1), and an outer protrusion (41) is provided on the proximal inner wall of the operating part (4). The gripping part (1) and the operating part (4) are engaged by inner and outer protrusions (12, 41) to form a sliding telescopic structure.

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