Microneedle structures, microneedle arrays, and injectors

Abstract

The application provides a microneedle structure, a microneedle array and a syringe, wherein the microneedle structure comprises: a needle head, the needle head comprising a needle tip part and a needle tube part, the needle tip part comprising an inclined surface and at least a part of the needle tip part being triangular in cross section, at least a part of the needle tube part being triangular in cross section, the needle head comprising an internal flow channel penetrating through the needle head; a boss, the needle head being located above the boss and connected with the boss, wherein the boss comprises an internal through hole penetrating through the boss, and the internal flow channel is in communication with the internal through hole. The microneedle structure, the microneedle array and the syringe provided by the application can significantly improve the drug utilization rate, enhance the structural stability and reduce the risk of needle breakage.

Description

Technical Field

[0001] This application relates primarily to the field of medical devices, and more particularly to a microneedle structure, a microneedle array, and a syringe. Background Technology

[0002] Microneedles are needle-shaped, micrometer-scale fine array structures. Subcutaneous microneedle puncture and sampling are important areas of development in the medical field. The main principle of drug delivery using microneedles is to open channels in the skin using hollow microneedles. These hollow microneedles have delivery channels connecting to a drug reservoir, and pressure is used to deliver the drug into the body. Drug delivery using microneedles is equivalent to subcutaneous injection.

[0003] Currently, hollow microneedles are prone to clogging the puncture site after skin puncture. Due to the conical structure of the needle tip, the wall thickness of the needle tip is small, resulting in low mechanical strength. This can easily lead to needle breakage or failure to penetrate the skin, posing safety and usage risks. Furthermore, the microneedle structure currently on the market cannot adjust the puncture depth, making the puncture depth uncontrollable and resulting in a short retention time for the drug solution after metabolism. Utility Model Content

[0004] The technical problem to be solved by this application is to provide a microneedle structure, microneedle array and syringe that can significantly improve drug utilization, enhance structural stability and reduce the risk of needle breakage.

[0005] To address the aforementioned technical problems, this application provides a microneedle structure, comprising: a needle tip, the needle tip including a needle tip portion and a needle tube portion, the needle tip portion including an inclined surface and at least a portion of the needle tip portion having a triangular cross-section, at least a portion of the needle tube portion having a triangular cross-section, the needle tip including an internal flow channel penetrating the needle tip; and a boss, the needle tip located above and connected to the boss, wherein the boss includes an internal through hole penetrating the boss, the internal flow channel communicating with the internal through hole.

[0006] Optionally, the needle tube portion includes a first transition portion and a needle tube, the first transition portion being located below the needle tube, and the needle tube being connected to the boss through the first transition portion.

[0007] Optionally, the needle tube includes three needle tube surfaces, each needle tube surface being located at a distance from the built-in flow channel that increases from top to bottom, and at least a portion of the edges of any two adjacent needle tube surfaces overlapping.

[0008] Optionally, the needle tube has multiple long sides and multiple short sides at one end near the first transition portion. The first transition portion includes a long side transition portion and a short side transition portion, wherein the long side transition portion extends downward and outward from the long side to the boss, and the short side transition portion includes a first short side transition portion extending downward and outward from the short side to the boss, and a second short side transition portion extending upward from the short side to between every two adjacent needle tube surfaces. The first short side transition portion and the long side transition portion have an arc-shaped structure, and the second short side transition portion has a triangular structure that tapers from bottom to top.

[0009] Optionally, the boss is a trapezoidal structure, and the boss has multiple boss edges below it. The microneedle structure also includes multiple second transition portions extending downward and outward from the boss edges, wherein each pair of adjacent second transition portions forms a U-shaped groove.

[0010] Optionally, the angle between the inclined surface and the horizontal plane is in the range of 20° to 30°.

[0011] Optionally, the height of the needle is in the range of 0.5mm to 1.2mm, wherein the height of the needle tip is in the range of 0.05mm to 0.5mm.

[0012] Optionally, the diameter of the built-in flow channel of the needle is in the range of 30μm-100μm, and the diameter of the built-in through hole of the boss is in the range of 30μm-100μm.

[0013] Optionally, the built-in flow channel forms flow channel holes on the inclined surface, and the area of ​​the flow channel holes accounts for 20% to 80% of the area of ​​the inclined surface.

[0014] This application also proposes a microneedle array, comprising: a plurality of microneedle structures as described above; a base, the base at least partially comprising a cavity, the base being located below the plurality of microneedle structures, the cavity being connected to the built-in through hole of the boss.

[0015] Optionally, the distance between the tips of two adjacent microneedle structures ranges from 1 mm to 5 mm.

[0016] This application also proposes a syringe, comprising: a microneedle array as described above; a microneedle base, the microneedle base including a microneedle slot and an injection cavity, the base of the microneedle array engaging with the microneedle slot, the cavity of the base communicating with the injection cavity; a negative pressure channel communicating with the microneedle base; and an injection cylinder communicating with the injection cavity.

[0017] Compared with the prior art, this application sets the cross-section of the needle tip and the needle tube of the microneedle structure to be triangular. The triangular needle structure can reduce the risk of blockage of the drug delivery channel during puncture. Since the triangular needle structure can further reduce the distance of the drug delivery channel within a limited range, it can significantly improve the drug utilization rate and improve the stability of the needle structure, reducing the risk of needle breakage. Attached Figure Description

[0018] The accompanying drawings are included to provide a further understanding of this application; they are incorporated into and constitute a part of this application. The drawings illustrate embodiments of this application and, together with this specification, serve to explain the principles of this application. In the drawings:

[0019] Figure 1 This is a schematic diagram of a microneedle structure in one embodiment of this application;

[0020] Figure 2 This is a schematic diagram of the structure of a microneedle array in one embodiment of this application;

[0021] Figure 3 This is a three-dimensional schematic diagram of the overall structure of a syringe according to an embodiment of this application;

[0022] Figure 4 Is it like this? Figure 3 The illustrated embodiment is a top view of the structure of a syringe. Detailed Implementation

[0023] To more clearly illustrate the technical solutions of the embodiments of this application, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the drawings described below are merely some examples or embodiments of this application. For those skilled in the art, these drawings can be applied to other similar scenarios without creative effort. Unless obvious from the context or otherwise specified, the same reference numerals in the drawings represent the same structures or operations.

[0024] As indicated in this application and claims, unless the context clearly indicates otherwise, the words "a," "an," "an," and / or "the" are not specifically singular and may include plural forms. Generally speaking, the terms "comprising" and "including" only indicate the inclusion of explicitly identified steps and elements, which do not constitute an exclusive list, and the method or apparatus may also include other steps or elements.

[0025] Unless otherwise specifically stated, the relative arrangement, numerical expressions, and values ​​of the components and steps described in these embodiments do not limit the scope of this application. It should also be understood that, for ease of description, the dimensions of the various parts shown in the drawings are not drawn to actual scale. Techniques, methods, and devices known to those skilled in the art may not be discussed in detail, but where appropriate, such techniques, methods, and devices should be considered part of the specification. In all examples shown and discussed herein, any specific values ​​should be interpreted as merely exemplary and not as limitations. Therefore, other examples of exemplary embodiments may have different values. It should be noted that similar reference numerals and letters in the following drawings denote similar items; therefore, once an item is defined in one drawing, it need not be further discussed in subsequent drawings.

[0026] In the description of this application, it should be understood that the orientation or positional relationship indicated by directional terms such as "front, back, up, down, left, right", "horizontal, vertical, horizontal" and "top, bottom" is usually based on the orientation or positional relationship shown in the accompanying drawings, and is only for the convenience of describing this application and simplifying the description. Unless otherwise stated, these directional terms do not indicate or imply that the device or element referred to must have a specific orientation or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation on the scope of protection of this application; the directional terms "inner" and "outer" refer to the inner and outer contours relative to the outline of each component itself.

[0027] For ease of description, spatial relative terms such as "above," "on top of," "on the upper surface of," "above," etc., are used herein to describe the spatial positional relationship of a device or feature as shown in the figures to other devices or features. It should be understood that spatial relative terms are intended to encompass different orientations in use or operation beyond the orientation of the device as described in the figures. For example, if the device in the figures were inverted, a device described as "above" or "on top of" other devices or structures would subsequently be positioned as "below" or "under" other devices or structures. Thus, the exemplary term "above" can include both "above" and "below." The device may also be positioned in other different ways (rotated 90 degrees or in other orientations), and the spatial relative descriptions used herein will be interpreted accordingly.

[0028] Furthermore, it should be noted that the use of terms such as "first" and "second" to define components is merely for the purpose of distinguishing the corresponding components. Unless otherwise stated, these terms have no special meaning and therefore should not be construed as limiting the scope of protection of this application. In addition, although the terminology used in this application is selected from commonly known and used terms, some terms mentioned in this application's specification may have been chosen by the applicant according to his or her judgment, and their detailed meanings are explained in the relevant sections of this description. Moreover, this application should be understood not only through the actual terms used, but also through the meaning implied by each term.

[0029] This application refers to Figure 1 A microneedle structure 10 is shown, with reference to Figure 1 The microneedle structure 10 includes a needle tip 11 and a boss 12. Specifically, the needle tip 11 includes a needle tip portion 111 and a needle tube portion 112. The needle tip portion 111 includes an inclined surface S1, and in this embodiment, the cross-section of the needle tip portion 111 is triangular, and the cross-section of part of the needle tube portion 112 is triangular. The needle tip 11 includes an internal flow channel 113 that penetrates the needle tip. The needle tip 11 is located above and connected to the boss 12. The boss 12 includes an internal through hole (not shown in the figure) that penetrates the boss 12. The internal flow channel 113 communicates with the internal through hole, allowing the liquid medicine to flow through the internal through hole of the boss 12 to the internal flow channel 113 of the needle tip 11 and finally enter the human body.

[0030] In this embodiment, by setting the cross-section of the needle tip 111 and the cross-section of part of the needle tube 112 to be triangular, the risk of blockage of the drug delivery channel during puncture can be reduced. Furthermore, the triangular needle structure can further reduce the distance of the drug delivery channel within a limited range, which can significantly improve the utilization rate of the drug and improve the stability of the needle structure, thereby reducing the risk of needle breakage.

[0031] Further, continue to refer to Figure 1 The needle tube portion 112 includes a first transition portion 21 and a needle tube 22. The first transition portion 21 is located below the needle tube 22, and the needle tube 22 is connected to the boss 12 through the first transition portion 21. Further, the needle tube 22 includes three needle tube surfaces S2, and the distance of each needle tube surface S2 from the built-in flow channel increases from top to bottom. Parts of the edges x of every two adjacent needle tube surfaces S2 coincide.

[0032] In this embodiment, refer to Figure 1The needle tube 22 has multiple long sides y1 and multiple short sides y2 at one end near the first transition portion 21. The first transition portion 21 includes a long side transition portion 23 and a short side transition portion 24. The long side transition portion 23 extends downward and outward from the long side y1 to the boss 12. The short side transition portion 24 includes a first short side transition portion 241 extending downward and outward from the short side y2 to the boss 12, and a second short side transition portion 242 extending upward from the short side y2 to between every two adjacent needle tube surfaces S2. The first short side transition portion 241 and the long side transition portion 23 have an arc-shaped structure, while the second short side transition portion 242 has a triangular structure that tapers from bottom to top. In other embodiments of this application, the second short side transition portion 242 may also be determined to have other regular or irregular structures that taper from top to bottom, depending on the actual application process; this application does not impose any limitations on this.

[0033] On the other hand, the boss 12 can be a trapezoidal structure, with multiple boss edges y3 below the boss 12. The microneedle structure 10 also includes multiple second transition portions 31 extending downward and outward from the boss edges y3, wherein each pair of adjacent second transition portions 31 forms a U-shaped groove 32. In this embodiment, the microneedle structure 10 can be integrally formed by 3D printing, and its material can be ceramic. Through the setting of the first transition portion 21 and the second transition portion 31, the overall structure of the microneedle structure 10 is smoother, thereby enabling the microneedle structure 10 to be better prepared by 3D printing. Furthermore, since the microneedle is made of ceramic, the microneedle structure 10 has greater strength, significantly increasing its stability and greatly reducing the risk of needle breakage.

[0034] Continue to refer to Figure 1 The angle between the inclined surface S1 and the horizontal plane ranges from 20° to 30°, for example, 20°, 23°, 25°, 28°, and 30°. In this embodiment, 20° is preferred. By setting the angle between the inclined surface S1 and the horizontal plane to 20°, the overall inclination of the needle 11 is reduced. For some highly viscous medications, this shortens the path the medication takes to enter the body, further reducing the risk of medication blockage.

[0035] Furthermore, the height of the needle 11 ranges from 0.5mm to 1.2mm, for example, 0.5mm, 0.7mm, 1.0mm, and 1.2mm, wherein the height of the needle tip 111 ranges from 0.05mm to 0.5mm. The microneedle structure 10 provided in this application can be replaced with microneedle structures of different heights according to different usage scenarios. This allows for adjustment of the puncture depth to achieve controllable puncture depth, while also enabling lower injection depths, thereby reducing drug metabolism and prolonging drug residence time.

[0036] On the other hand, the diameter of the built-in flow channel 113 of the needle 11 ranges from 30μm to 100μm, and the diameter of the built-in through hole of the boss 12 ranges from 30μm to 100μm. Preferably, in this embodiment, the diameter range of the built-in flow channel 113 and the diameter range of the built-in through hole are the same. Furthermore, the built-in flow channel forms a flow channel hole 33 on the inclined surface, and the area of ​​the flow channel hole 33 accounts for 20% to 80% of the area of ​​the inclined surface S1. Through the above arrangement, the drug solution can better enter the human body through the built-in through hole and the built-in flow channel 113, further improving the injection effect and enhancing the absorption effect of the drug solution by the human body.

[0037] In another aspect, this application proposes a microneedle array, which includes multiple microneedle structures proposed in any embodiment of this application, such as the microneedle structure 10 described above. Figure 2 A microneedle array 20 formed by multiple microneedle structures 10 is shown. The microneedle array 20 also includes a base 41, which at least partially includes a cavity. The base 41 is located below the multiple microneedle structures 10, and the cavity communicates with the built-in through hole of the boss 12. In this application, the distance between the needle tips 111 of each adjacent pair of microneedle structures 10 ranges from 1 mm to 5 mm, for example, 1 mm, 2 mm, 3 mm, 4 mm, and 5 mm. In this embodiment, 1 mm is preferred. The smaller the distance between the microneedle structures 10, the denser the microneedle array 20 becomes, and therefore the more microneedle structures 10 are in the microneedle array 20, which can reduce the amount of drug solution per needle and significantly improve drug utilization.

[0038] For example, the arrangement of microneedle structures 10 in the microneedle array 20 can be a 3×3 array, a 6×6 array, or a 9×9 array, which can be adjusted according to the actual application. This application does not impose any restrictions on this.

[0039] This application also refers to Figures 3-4 A syringe 30 is proposed, comprising a microneedle array as proposed in any embodiment of this application, such as the microneedle array 20 described above. The syringe 30 also includes a microneedle base 42, which includes a microneedle slot 43, an injection chamber 44, and an air extraction chamber 47. The base 41 of the microneedle array 20 is engaged with the microneedle slot 43, enabling the installation and replacement of different microneedle arrays. The cavity of the base 41 is connected to the injection chamber 44. During drug injection, the drug is injected into the injection chamber 44. Since the injection chamber 44 is connected to the cavity of the base 41, and the cavity is also connected to the internal through-hole of the boss 12 and the internal flow channel 113 of the needle 11, the entire assembly forms the channel through which the drug flows from the syringe 30 into the human body. The syringe 30 also includes a negative pressure channel 45 and an injection cylinder 46, wherein the injection cylinder 46 is connected to the injection chamber 44, and the liquid is injected into the injection chamber 44 through the injection cylinder 46. The negative pressure channel 45 is connected to the microneedle base 42, and the negative pressure channel 45 provides negative pressure to inject the liquid in the syringe 30 into the human body.

[0040] The basic concepts have been described above. Obviously, for those skilled in the art, the above disclosure is merely illustrative and does not constitute a limitation of this application. Although not explicitly stated herein, those skilled in the art may make various modifications, improvements, and corrections to this application. Such modifications, improvements, and corrections are suggested in this application, and therefore remain within the spirit and scope of the exemplary embodiments of this application.

[0041] Furthermore, this application uses specific terms to describe embodiments of the application. For example, "an embodiment," "one embodiment," and / or "some embodiments" refer to a particular feature, structure, or characteristic related to at least one embodiment of the application. Therefore, it should be emphasized and noted that "an embodiment," "one embodiment," or "an alternative embodiment" mentioned twice or more in different locations in this specification do not necessarily refer to the same embodiment. In addition, certain features, structures, or characteristics in one or more embodiments of the application can be appropriately combined.

[0042] Similarly, it should be noted that, in order to simplify the description of the present application and thus aid in the understanding of one or more embodiments, the foregoing description of the embodiments of the present application sometimes combines multiple features into a single embodiment, drawing, or description thereof. However, this disclosure method does not imply that the subject matter of the present application requires more features than those mentioned in the claims. In fact, the embodiments contain fewer features than all the features of the single embodiments disclosed above.

[0043] In some embodiments, numbers describing the quantity of components and attributes are used. It should be understood that such numbers used in the description of embodiments are modified in some examples with the terms "approximately," "approximately," or "generally." Unless otherwise stated, "approximately," "approximately," or "generally" indicates that the numbers are allowed to vary by ±20%. Accordingly, in some embodiments, the numerical parameters used in the specification and claims are approximate values, which may be changed depending on the characteristics required by individual embodiments. In some embodiments, numerical parameters should take into account specified significant digits and employ a general method of digit reservation. Although the numerical ranges and parameters used to confirm their breadth of scope in some embodiments of this application are approximate values, in specific embodiments, such values ​​are set as precisely as feasible.

[0044] Although this application has been described with reference to specific embodiments, those skilled in the art should recognize that the above embodiments are only used to illustrate this application, and various equivalent changes or substitutions can be made without departing from the spirit of this application. Therefore, any changes or modifications to the above embodiments within the essential spirit of this application will fall within the scope of the claims of this application.

Claims

1. A microneedle structure, characterized in that, The microneedle structure includes: A needle, comprising a needle tip and a needle tube, the needle tip having an inclined surface and at least a portion of the needle tip having a triangular cross-section, at least a portion of the needle tube having a triangular cross-section, and the needle including an internal flow channel penetrating the needle; A boss, wherein the needle is located above the boss and connected to the boss, wherein the boss includes an internal through hole through the boss, and the internal flow channel communicates with the internal through hole.

2. The microneedle structure as described in claim 1, characterized in that, The needle tube portion includes a first transition portion and a needle tube, the first transition portion being located below the needle tube, and the needle tube being connected to the boss through the first transition portion.

3. The microneedle structure as described in claim 2, characterized in that, The needle tube includes three needle tube surfaces, the distance of each needle tube surface from the built-in flow channel increases from top to bottom, and at least part of the edges of every two adjacent needle tube surfaces overlap.

4. The microneedle structure as described in claim 3, characterized in that, The needle tube has multiple long sides and multiple short sides at one end near the first transition portion, and the first transition portion includes a long-side transition portion and a short-side transition portion, wherein... The long side transition portion extends downward and outward from the long side to the boss. The short side transition portion includes a first short side transition portion extending downward and outward from the short side to the boss, and a second short side transition portion extending upward from the short side to between every two adjacent needle tube surfaces. The first short side transition portion and the long side transition portion have an arc-shaped structure, and the second short side transition portion has a triangular structure that tapers from bottom to top.

5. The microneedle structure as described in claim 1, characterized in that, The protrusion has a trapezoidal structure, and its lower surface includes multiple protrusion edges. The microneedle structure also includes multiple second transition portions extending downward and outward from the protrusion edges. Each pair of adjacent second transition sections forms a U-shaped groove.

6. The microneedle structure as described in claim 1, characterized in that, The angle between the inclined plane and the horizontal plane is in the range of 20° to 30°.

7. The microneedle structure as described in claim 1, characterized in that, The height of the needle is in the range of 0.5mm to 1.2mm, and the height of the needle tip is in the range of 0.05mm to 0.5mm.

8. The microneedle structure as described in claim 1, characterized in that, The diameter of the built-in flow channel of the needle is in the range of 30μm-100μm, and the diameter of the built-in through hole of the boss is in the range of 30μm-100μm.

9. The microneedle structure according to any one of claims 1 to 8, characterized in that, The built-in flow channel forms flow channel holes on the inclined surface, and the area of ​​the flow channel holes accounts for 20% to 80% of the area of ​​the inclined surface.

10. A microneedle array, characterized in that, include: Multiple microneedle structures as described in any one of claims 1 to 9; A base, at least partially comprising a cavity, the base being located below the plurality of microneedle structures, the cavity being connected to the built-in through hole of the boss.

11. The microneedle array as described in claim 10, characterized in that, The distance between the tips of any two adjacent microneedle structures ranges from 1 mm to 5 mm.

12. A syringe, characterized in that, include: The microneedle array as described in any one of claims 10-11; A microneedle base, comprising a microneedle slot and an injection cavity, wherein the base of the microneedle array is engaged with the microneedle slot, and the cavity of the base is in communication with the injection cavity; A negative pressure channel, which is connected to the microneedle base; The injection cylinder is connected to the injection cavity.

Images