CN222172857U

CN222172857U - Microneedle injection device

Info

Publication number: CN222172857U
Application number: CN202323453499.5U
Authority: CN
Inventors: 张嘉荣; 黄远; 刘龙; 曲秋羽
Original assignee: Shanghai Yuefuda Biotechnology Co ltd; Suzhou Reveda Medical Biotech Co Ltd
Current assignee: Shanghai Yuefuda Biotechnology Co ltd; Suzhou Reveda Medical Biotech Co Ltd
Priority date: 2023-12-18
Filing date: 2023-12-18
Publication date: 2024-12-17
Anticipated expiration: 2033-12-18

Abstract

The utility model provides a microneedle injection device, which includes an injection assembly and a mold assembly; the injection assembly includes an injection rod and a syringe, the syringe has an injection outlet; the injection rod is movably arranged on the syringe along the axial direction of the syringe; the mold assembly has an injection port and an inner cavity connected to the injection port, the inner cavity is used to accommodate a microneedle mold; the mold assembly is abutted against the syringe, the injection port is connected to the injection outlet; the injection rod and the mold assembly are configured to apply pressure relative to each other. With such a configuration, the molding liquid can be injected into the microneedle mold in the mold assembly, and the microneedle mold is placed in the mold assembly and can be supported by the mold assembly. Further, based on the relative pressure between the injection rod and the mold assembly, the pressure-maintaining function can be realized, the density and mechanical strength of the prepared microneedle are improved, and the needle tip shape of the prepared microneedle is better.

Description

Microneedle injection device

Technical Field

The utility model relates to the technical field of medical appliances, in particular to a microneedle injection device.

Background

The micro-needle is a novel minimally invasive drug delivery tool, and can create micro-nano pore channels by puncturing the epidermis stratum corneum so as to facilitate the drug to enter dermis and subcutaneous tissues and be absorbed by capillary vessels. The microneedle needs to be able to penetrate the skin, so the needle body of the microneedle needs to have good mechanical strength, and the higher the needle tip size accuracy of the microneedle is, the better.

The polymer microneedle has the advantages of low production cost, high needle tip precision and high needle strength. The polymer microneedles in the prior art are often prepared by a hot pressing method or a soluble material pouring method, wherein the strength of the polymer microneedles prepared by the soluble material pouring method is lower. The hot pressing method is poor in material filling degree, the micro-needle is mainly formed by pressure difference driving, and when the depth-to-width ratio of the micro-needle is large, the needle point forming is difficult to ensure. In addition, the hot pressing method is easy to cause insufficient density of the micro-needle, so that the mechanical strength of the micro-needle is poor.

Disclosure of utility model

The utility model aims to provide a microneedle injection device which solves the problems of poor needle point shape and poor microneedle strength of the existing microneedle molding.

In order to solve the technical problems, the utility model provides a microneedle injection device, which comprises an injection assembly and a mould assembly;

The injection assembly comprises an injection rod and an injection cylinder, wherein the injection cylinder is provided with an injection outlet, and the injection rod is movably arranged on the injection cylinder along the axial direction of the injection cylinder;

the mould component is provided with an injection opening and an inner cavity communicated with the injection opening, wherein the inner cavity is used for accommodating a microneedle mould;

the injection rod and the mold assembly are configured to be relatively pressurized.

Optionally, the mould subassembly includes separable cope match-plate pattern and lower bolster, the filling opening set up in the cope match-plate pattern, the cope match-plate pattern with the lower bolster encloses after the assembly connection and closes and form the inner chamber.

Optionally, the die assembly comprises a flow guide piece, wherein the flow guide piece is arranged in the inner cavity and is intersected with the extending direction of the injection port, and the inner cavity forms a forming cavity under the partition of the flow guide piece;

Optionally, the flow guiding piece has with the chute that the filling opening is arranged at an angle, the flow guiding piece with the cope match-plate pattern is connected and covers the filling opening, the one end of chute with the filling opening intercommunication, the other end of chute with the shaping chamber intercommunication.

Optionally, the runner comprises a narrow section and an expansion section, wherein the narrow section is positioned at one end of the runner, which is communicated with the injection port, and the expansion section is positioned at one end of the runner, which is communicated with the forming cavity.

Optionally, the lower template is provided with a mould accommodating groove matched with the shape of the microneedle mould, and the mould accommodating groove forms a part of the inner cavity after the lower template is assembled and connected with the upper template.

Optionally, the microneedle injection device further comprises a lower template fixing assembly detachably connected with the lower template to define the position of the lower template.

Optionally, the lower bolster fixed subassembly includes first mounting and the second mounting of mutual block connection, first mounting with after the assembly is connected in mutual block to the second mounting, form with the spacing chamber of the profile shape looks adaptation of lower bolster, the lower bolster holding in spacing chamber, and with the chamber wall in spacing chamber supports.

Optionally, the microneedle injection apparatus further comprises a hot press, the hot press comprises a pressing component and a heating base, the injection rod is connected with the pressing component, the die assembly is arranged on the heating base, and the pressing component is configured to press towards the direction of the heating base.

Optionally, the microneedle injection apparatus further comprises the microneedle mould.

In summary, the microneedle injection device provided by the utility model comprises an injection assembly and a mold assembly, wherein the injection assembly comprises an injection rod and an injection cylinder, the injection cylinder is provided with an injection outlet, the injection rod is movably arranged on the injection cylinder along the axial direction of the injection cylinder, the mold assembly is provided with an injection opening and an inner cavity communicated with the injection opening, the inner cavity is used for accommodating a microneedle mold, the mold assembly is in abutting connection with the injection cylinder, the injection opening is communicated with the injection outlet, and the injection rod and the mold assembly are configured to be pressed relatively.

The microneedle injection apparatus provided by the utility model can be applied to a hot press, the injection assembly is arranged, the molding liquid (such as polymer materials after high-temperature hot melting) can be injected into the microneedle mould in the mould assembly in an injection mode, and the microneedle mould is arranged in the mould assembly, so that the microneedle mould can be supported by the mould assembly. Further based on the relative pressure between the injection rod and the die assembly, the pressure maintaining function can be realized, and the density and the mechanical strength of the prepared micro needle are improved. Is especially suitable for silica gel mold and micro needle with large width-depth ratio, and the prepared micro needle has better needle tip shape.

Drawings

Those of ordinary skill in the art will appreciate that the figures are provided for a better understanding of the present utility model and do not constitute any limitation on the scope of the present utility model. Wherein:

FIG. 1 is a schematic view of a microneedle injection apparatus according to an embodiment of the present utility model;

FIG. 2 is a schematic view of an injection assembly according to an embodiment of the present utility model;

FIG. 3 is a schematic view of an upper die plate according to an embodiment of the present utility model;

FIG. 4 is a schematic view of a baffle according to an embodiment of the present utility model;

FIG. 5 is a schematic view of a lower plate and lower plate securing assembly according to an embodiment of the present utility model;

FIG. 6 is an exploded view of a mold assembly and a lower plate retaining assembly according to an embodiment of the present utility model.

In the accompanying drawings:

10-injection assembly, 11-injection rod, 12-injection cylinder, 13-injection outlet;

20-a die assembly, 201-an upper die plate, 202-a lower die plate, 203-a concave cavity, 204-a screw hole, 205-a die accommodating groove, 21-a filling opening, 22-an inner cavity, 23-a guide piece, 231-a launder, 232-a fixing hole, 233-a narrow section, 234-an expanding section and 24-a forming cavity;

40-lower template fixing components, 41-first fixing pieces, 42-second fixing pieces and 43-limiting cavities.

Detailed Description

The utility model will be described in further detail with reference to the drawings and the specific embodiments thereof in order to make the objects, advantages and features of the utility model more apparent. It should be noted that the drawings are in a very simplified form and are not drawn to scale, merely for convenience and clarity in aiding in the description of embodiments of the utility model. Furthermore, the structures shown in the drawings are often part of actual structures. In particular, the drawings are shown with different emphasis instead being placed upon illustrating the various embodiments.

As used in this disclosure, the singular forms "a," "an," "the," and "the" include plural referents, the term "or" is generally used in the sense of comprising "and/or" and the term "several" is generally used in the sense of comprising "at least one," the term "at least two" is generally used in the sense of comprising "two or more," and, furthermore, the terms "first," "second," "third," are used for descriptive purposes only and are not to be construed as indicating or implying any particular importance or quantity of technical features indicated. Thus, a feature defining "first," "second," "third," or the like, may explicitly or implicitly include one or at least two such features, with "one end" and "another end" and "proximal end" and "distal end" generally referring to the corresponding two portions, including not only the endpoints. Furthermore, as used in this disclosure, "mounted," "connected," and "disposed" with respect to another element should be construed broadly to mean generally only that there is a connection, coupling, mating or transmitting relationship between the two elements, and that there may be a direct connection, coupling, mating or transmitting relationship between the two elements or indirectly through intervening elements, and that no spatial relationship between the two elements is to be understood or implied, i.e., that an element may be in any orientation, such as internal, external, above, below, or to one side, of the other element unless the context clearly dictates otherwise. The specific meaning of the above terms in the present utility model can be understood by those of ordinary skill in the art according to the specific circumstances. Furthermore, directional terms, such as above, below, upper, lower, upward, downward, left, right, etc., are used with respect to the exemplary embodiments as they are shown in the drawings, upward or upward toward the top of the corresponding drawing, downward or downward toward the bottom of the corresponding drawing.

The utility model aims to provide a microneedle injection device which solves the problems of poor needle point shape and poor microneedle strength of the existing microneedle molding. The following description refers to the accompanying drawings.

Referring to fig. 1 to 6, the present utility model provides a microneedle injection device, which comprises an injection assembly 10 and a mold assembly 20, wherein the injection assembly 10 comprises an injection rod 11 and an injection cylinder 12, the injection cylinder 12 is provided with an injection outlet 13, the injection rod 11 is movably arranged on the injection cylinder 12 along the axial direction of the injection cylinder 12, the mold assembly 20 is provided with an injection port 21 and an inner cavity 22 communicated with the injection port 21, and the inner cavity 22 is used for accommodating a microneedle mold (not shown). The injection rod 11 and the mold assembly 20 are configured to be relatively pressurized so that the injection rod 11 can push molding fluid (e.g., high temperature hot melt polymer material) contained in the injection barrel 12 out of the injection outlet 13, into the cavity 22 via the injection port 21, and into the cavity of the microneedle mould. And then a certain pressure is kept between the injection rod 11 and the mold assembly 20, and the mold assembly 20 is heated, so that the molding liquid is solidified under the pressure-keeping state, and finally the microneedle product is formed. The relative pressure herein means that the injection rod 11 and the mold assembly 20 are applied with a relative pressure. In particular, for example, the injection rod 11 and the mold assembly 20 may be placed in a heated press, which may be implemented by the heated press. In addition, the relative pressure may be understood as the relative pressure of the injection rod 11 and the mold assembly 20 gradually increases, or may be understood as the relative pressure of the injection rod 11 and the mold assembly 20 remains unchanged (i.e., maintains pressure).

A microneedle mould (e.g. a silicone mould) is a mould for the preparation of a microneedle product, which can be for example overmolded with a metal microneedle male mould, it being understood that the microneedle mould has a cavity for receiving a shaping fluid (e.g. a high temperature hot melt polymer material) which is injected into the cavity and cured to release the mould, whereby a microneedle product (e.g. a microneedle sheet comprising a plurality of microneedles) is obtained.

The size precision of the needle tip of the micro needle prepared by the silica gel mold is better than that of the needle tip of the micro needle prepared by the metal mold. However, the silica gel mold is a flexible mold, and is generally difficult to bear high pressure, so that the polymer microneedle is often prepared by adopting a hot pressing method by adopting the silica gel mold in the prior art. However, when the hot pressing method is adopted, the molding liquid fills the cavity by flowing, and the filling effect is relatively poor. In the microneedle injection apparatus provided in this embodiment, the mold assembly 20 is provided with the cavity 22 for accommodating the microneedle mould, and the microneedle mould is supported by the mold assembly 20 after being accommodated in the cavity 22 of the mold assembly 20. The mold assembly 20 may be, for example, a metal piece having relatively high strength. So configured, with the use of a hot press, molding fluid can be injected into the microneedle mould in the mould assembly 20 by injection, and the microneedle mould can be placed in the mould assembly 20 and supported by the mould assembly 20. Further, based on the relative pressure between the injection rod 11 and the mold assembly 20, the pressure maintaining function can be realized, and the density and mechanical strength of the prepared micro-needle can be improved. Is especially suitable for silica gel molds and microneedles with larger width-depth ratio, and the prepared microneedles have better needle tip appearance.

Referring to fig. 6 in combination with fig. 1, optionally, the mold assembly 20 includes a separable upper mold plate 201 and a lower mold plate 202, the injection port 21 is formed in the upper mold plate 201, and the upper mold plate 201 and the lower mold plate 202 are assembled and connected to each other to form the inner cavity 22. Configuring the mold assembly 20 to include separable upper and lower templates 201, 202 may facilitate loading and demolding of the microneedle molds. The upper die plate 201 and the lower die plate 202 can be fastened by using bolts, for example. Preferably, the upper template 201 is used to abut against the syringe 12, and the injection port 21 formed on the upper template 201 is aligned with and communicated with the injection outlet 13 on the syringe 12. When the injection rod 11 is pressed against the mold assembly 20 in this way, the injection rod 11 pushes the molding liquid contained in the injection cylinder 12 out of the injection outlet 13 and into the microneedle mould contained in the cavity 22 through the sprue 21. After the completion of the curing, the upper and lower templates 201 and 202 may be separated, and the microneedle mould may be taken out. It will be appreciated that in other embodiments, the mold assembly 20 is not limited to having to include a two-piece upper and lower mold plates 201, 202, but may be multi-piece, i.e., formed from a combination of sub-mold plates.

Referring to fig. 4 in combination with fig. 1 and 6, the mold assembly 20 further includes a guide member 23, wherein the guide member 23 is disposed in the inner cavity 22 and intersects with the extending direction of the injection port 21, the inner cavity 22 forms a forming cavity 24 under the partition of the guide member 23, and the guide member 23 is used for changing the flowing direction of the forming liquid flowing from the injection port 21. The microneedle mould is accommodated in the forming cavity 24, the flow guide piece 23 is equivalent to blocking between the injection opening 21 and the microneedle mould, and is used for blocking the injection opening 21, so that the flowing direction of forming liquid is changed, the forming liquid jet can be prevented from directly impacting the microneedle mould, and the distribution uniformity of the forming liquid in the microneedle mould is improved.

With continued reference to fig. 4, optionally, the flow guiding member 23 has a flow groove 231 disposed at an angle to the injection port 21, the flow guiding member 23 is connected to the upper mold plate 201 and covers the injection port 21, one end of the flow groove 231 is in communication with the injection port 21, and the other end of the flow groove 231 is in communication with the molding cavity 24. The flow grooves 231 are provided to define the flow direction of the molding liquid, so that the molding liquid can flow more uniformly into the molding cavity 24. In the example shown in fig. 4, the flow guide 23 has 4 flow grooves 231,4 with a cross-shaped arrangement of flow grooves 231, which enables the molding liquid to flow uniformly from four directions into the molding cavity 24. It is to be understood that the baffle 23 having 4 flow channels 231 is merely exemplary and not limiting of the baffle 23, and that the baffle 23 may have a greater or lesser number of flow channels 231 in other embodiments.

Referring to fig. 3 and 4, in an alternative example, a side of the upper mold plate 201 facing away from the syringe 12 has a cavity 203 adapted to the outer contour shape of the flow guiding element 23, and a plurality of screw holes 204 are provided in the cavity 203, the flow guiding element 23 has fixing holes 232 corresponding to the screw holes 204, and the flow guiding element 23 is fixed in the cavity 203 of the upper mold plate 201 by screwing bolts through the fixing holes 232 and the screw holes 204. Preferably, the area of the surface of the flow guide 23 facing the injection port 21 excluding the launder 231 abuts against the upper die plate 201, so that the molding liquid flowing in the injection port 21 is restricted to flow only in the launder 231.

Preferably, the runner 231 includes a narrow section 233 and an expanding section 234, the narrow section 233 being located at an end of the runner 231 in communication with the injection port 21, and the expanding section 234 being located at an end of the runner 231 in communication with the molding cavity 24. The expanded section 234 has a larger cross-sectional area than the narrow section 233 so that the molding liquid can be decelerated and expanded in the lateral direction when flowing toward the molding cavity 24, thereby further improving the uniformity of the flow of the molding liquid into the molding cavity 24.

Referring to fig. 5 and 6, the lower die plate 202 has a die receiving groove 205 adapted to the outer contour shape of the microneedle mould, and the die receiving groove 205 forms a part of the inner cavity 22, i.e. forms a part of the forming cavity 24 after the lower die plate 202 is assembled with the upper die plate 201. The shape of the mold accommodating groove 205 is adapted to the outer contour shape of the microneedle mould, which can perform a bearing function on the microneedle mould. It will be appreciated that by different arrangements of the flow guide 23, the mould receiving recess 205 may be part of the mould cavity 24 and the mould receiving recess 205 may be fully coincident with the mould cavity 24.

Preferably, the microneedle injection apparatus further comprises a lower template holder assembly 40, the lower template holder assembly 40 being detachably coupled to the lower template 202 to define the position of the lower template 202. In use, the lower die plate 202 is adapted to rest on a heated base of a hot press. The lower die plate fixing assembly 40 can fix the lower die plate 202 on the heating base, so that the position of the lower die plate 202 is prevented from moving.

In an alternative example, the lower die plate fixing assembly 40 includes a first fixing member 41 and a second fixing member 42 that are in engaged connection with each other, and after the first fixing member 41 and the second fixing member 42 are assembled in an engaged connection, a limiting cavity 43 that matches the contour shape of the lower die plate 202 is formed, and the lower die plate 202 is accommodated in the limiting cavity 43 and abuts against a cavity wall of the limiting cavity 43. The first fixing member 41 and the second fixing member 42 can be fixed to the heating base by bolts, for example, and thus can reliably define the position of the lower die plate 202.

Further, the microneedle injection apparatus may further comprise a hot press (not shown) including a pressing member to which the injection rod 11 is connected and a heating base to which the mold assembly 20 is placed, the pressing member being configured to press toward the heating base so that the injection rod 11 and the mold assembly 20 are configured to relatively press. Preferably, the microneedle injection apparatus further comprises the microneedle mould.

Preferably, the microneedle injection apparatus provided by the present embodiment is configured to be used in a negative pressure environment.

The following exemplarily describes the steps of using the microneedle injection apparatus according to the present embodiment.

Step S1, a microneedle mould is placed in the inner cavity 22 of the mould assembly 20, specifically in the mould accommodating groove 205, and then the upper mould plate 201 and the lower mould plate 202 are assembled and connected.

And S2, adding polymer granules such as PP and PLA into the injection cylinder 12, wherein the mass of the polymer granules can be 1 g-499 g. The hot pressing pressure is set to be 0.1-5 MPa, and the hot pressing time is set to be 60-600 s. The syringe 12 is heated to melt the polymer pellets therein and form a flowable molding fluid. Further, in this case, it is preferable to vacuum the environment where the hot press is located to form a negative pressure environment, and the vacuum degree can be set to-90 kPa, for example.

Step S3, starting the hot press, pressing the pressing part towards the direction of the heating base, driving the injection rod 11 to move towards the direction of the injection outlet 13, extruding the molding liquid, and finally injecting the molding liquid into the cavity of the microneedle mould through the injection outlet 13, the injection inlet 21, the launder 231 and the molding cavity 24 in sequence.

And S4, after the pressure of the pressing component reaches the set hot pressing pressure, stopping pressing the pressing component, and stopping moving the injection rod 11, so that the pressure of the forming liquid is not increased any more, and a pressure maintaining state is formed until the set hot pressing time is reached. The pressure exerted by the hold down on the injection rod 11 helps to increase the polymer density of the microneedle product and reduce the shrinkage ratio. Further, the environment where the hot press is located can be broken in vacuum preferably, namely, the environment where the hot press is located is restored to normal pressure, so that the pressure difference is formed between the cavity of the microneedle mould and the external environment, and the filling degree of the forming liquid filled into the cavity of the microneedle mould can be improved by the configuration, and the forming quality of the needle tip can be improved.

And S5, lifting the pressing component, taking out the die assembly 20, separating the upper die plate 201 from the lower die plate 202, taking out the microneedle mould, and demolding to obtain the microneedle product. Preferably, in this step, the mold assembly 20 may also be air-cooled or water-cooled to reduce the risk of scalding and increase the turnover speed of the mold assembly 20.

In summary, the microneedle injection device provided by the utility model comprises an injection assembly and a mold assembly, wherein the injection assembly comprises an injection rod and an injection cylinder, the injection cylinder is provided with an injection outlet, the injection rod is movably arranged on the injection cylinder along the axial direction of the injection cylinder, the mold assembly is provided with an injection opening and an inner cavity communicated with the injection opening, the inner cavity is used for accommodating a microneedle mold, the mold assembly is in abutting connection with the injection cylinder, the injection opening is communicated with the injection outlet, and the injection rod and the mold assembly are configured to be pressed relatively. The microneedle injection apparatus provided by the utility model can be applied to a hot press, the injection assembly is arranged, the molding liquid (such as polymer materials after high-temperature hot melting) can be injected into the microneedle mould in the mould assembly in an injection mode, and the microneedle mould is arranged in the mould assembly, so that the microneedle mould can be supported by the mould assembly. Further based on the relative pressure between the injection rod and the die assembly, the pressure maintaining function can be realized, and the density and the mechanical strength of the prepared micro needle are improved. Is especially suitable for micro-needles with larger width-depth ratio, and the prepared micro-needles have better needle tip appearance.

It should be noted that the above embodiments may be combined with each other. The above description is only illustrative of the preferred embodiments of the present utility model and is not intended to limit the scope of the present utility model, and any alterations and modifications made by those skilled in the art based on the above disclosure shall fall within the scope of the present utility model.

Claims

1. A microneedle injection apparatus comprises an injection assembly and a mold assembly;

2. The microneedle injection apparatus of claim 1, wherein the mold assembly comprises a separable upper mold plate and a lower mold plate, the injection port being open to the upper mold plate, the upper mold plate being assembled with the lower mold plate and then enclosed to form the interior cavity.

3. The microneedle injection apparatus of claim 2, wherein the mold assembly comprises a flow guide disposed in the inner cavity and intersecting the direction of extension of the injection port, the inner cavity forming a molding cavity under the partition of the flow guide, the flow guide being for changing the flow direction of the molding liquid flowing from the injection port.

4. A microneedle injection device according to claim 3, wherein the flow guide member has a runner arranged at an angle to the injection port, the flow guide member being connected to the upper die plate and covering the injection port, one end of the runner being in communication with the injection port, the other end of the runner being in communication with the molding cavity.

5. The microneedle injection apparatus of claim 4, wherein the runner comprises a narrow section at an end of the runner in communication with the injection port and an expanded section at an end of the runner in communication with the molding cavity.

6. The microneedle injection apparatus of claim 2, wherein the lower die plate has a die receiving groove adapted to an outer contour shape of the microneedle die, the die receiving groove constituting a portion of the inner cavity after the lower die plate is assembled with the upper die plate.

7. The microneedle injection device of claim 2, further comprising a lower template securement assembly removably coupled with the lower template to define a position of the lower template.

8. The microneedle injection device of claim 7, wherein the lower template fixing assembly comprises a first fixing piece and a second fixing piece which are mutually clamped and connected, a limiting cavity matched with the outline shape of the lower template is formed after the first fixing piece and the second fixing piece are mutually clamped and connected and assembled, and the lower template is accommodated in the limiting cavity and abuts against the cavity wall of the limiting cavity.

9. The microneedle injection apparatus of claim 1, further comprising a heated press comprising a hold-down member and a heating base, the injection rod being coupled to the hold-down member, the mold assembly being disposed on the heating base, the hold-down member being configured to apply pressure in a direction toward the heating base.

10. A microneedle injection device according to claim 1, wherein, the microneedle injection apparatus further comprises the microneedle mould.