CN217526091U - Microneedle patch with easily torn substrate - Google Patents

Abstract

The utility model relates to a micropin subsides are easily torn to base, include the stratum basale and set up the micropin on the stratum basale, the micropin includes the micropin main part and sets up 1 at least fixed part in the micropin main part. The connection part of the micro-needle and the basal layer is provided with a stress point structure for tearing and separating the micro-needle and the basal layer. The substrate layer and the microneedles are integrally formed. The micro-needle substrate tearing and separating device has the advantages that the stress point structure used for tearing and separating the micro-needle from the substrate layer is arranged at the joint of the micro-needle and the substrate layer, the stress point structure has a large stress concentration phenomenon, and when the substrate layer is torn off, the substrate layer at the stress point structure and the micro-needle are small in breaking and separating critical stress, so that the substrate layer and the micro-needle can be broken and separated under the action of small external force to tear off the substrate layer.

Description

Microneedle patch with easily torn substrate

Technical Field

The utility model relates to a micropin technical field especially relates to a basement easily tears micropin subsides.

Background

In recent centuries, metal injection needles have been widely used in the medical industry as the mainstream instruments for drug injection, but the pain and fear caused by the use of metal injection needles are unacceptable to some people (especially children). With the progress and development of technology, microneedle patches for drug injection have come out.

The microneedle patch generally comprises a substrate layer and microneedles which are sequentially arranged from top to bottom, and the microneedles are soluble. When in use, the microneedle is stuck on one side of the microneedle and pressed on the skin until the microneedle is punctured into the skin and the substrate layer is stuck on the skin. Because the length of the microneedle is short, the microneedle does not cause nerve injury and pain of a patient in the process of puncturing the skin, and is gradually accepted by the public.

To achieve stable insertion of microneedles into the skin, the prior art includes the following two ways:

the first mode is as follows: the stratum basale is the stickness sticky tape, guarantees that the microneedle pricks into the skin after, and the stratum basale can maintain the adhesion at the skin surface to the realization is given power to lasting of microneedle to tear off the stratum basale after the microneedle dissolves. However, people allergic to viscose can not use the microneedle patch, and children or other special patients, pets and the like can not realize the drug administration effect of the microneedle due to the fact that the basal layer falls off caused by scratching.

The second mode is as follows: through formula control, the root of the microneedle connected with the substrate is provided with an easy-to-dissolve layer relative to the medicine-containing component, but because the root of the microneedle close to the substrate layer is close to the horny layer of the skin, the dissolving rate of the microneedle material which is dissolved immediately when meeting water in the skin is extremely slow, and the easy-to-dissolve layer has long dissolving time, so that the practical feasibility of easily tearing the substrate layer after the microneedle is dissolved is limited.

SUMMERY OF THE UTILITY MODEL

Technical problem to be solved

In view of the above-mentioned shortcoming, the deficiency of prior art, the utility model provides a micropin subsides are easily torn to base, it has solved current micropin subsides and is difficult to tear the technical problem that the stratum basale was torn by on the micropin when using to and wait to tear the longer technical problem of stratum basale required time again after the micropin dissolves.

(II) technical scheme

In order to achieve the above object, the utility model discloses a main technical scheme include:

the embodiment of the utility model provides a microneedle sticker with easily torn base, which comprises a base layer and microneedles arranged on the base layer, wherein the microneedles comprise microneedle main bodies and at least 1 fixing part arranged on the microneedle main bodies;

a stress point structure used for tearing and separating the microneedle from the substrate layer is arranged at the joint of the microneedle and the substrate layer;

the substrate layer and the microneedles are of an integrally formed structure.

According to the invention, the fixing part comprises a protrusion, the extension direction of the protrusion forms an angle alpha with the axis of the microneedle main body, and the angle alpha is larger than or equal to 15 degrees and smaller than or equal to 75 degrees.

According to the invention, the included angle between the extending direction of the protrusion and the axis of the microneedle main body is alpha, and alpha is more than or equal to 30 degrees and less than or equal to 60 degrees.

According to the present invention, when the number of the projections is 2 or more in the direction in which the microneedle base extends toward the needle tip, the horizontal projection area and the volume of the plurality of projections increase in sequence.

According to the invention, the stress point structure comprises a base through hole arranged on the base layer and on the same side as the fixing part on the microneedle.

According to the invention, the stress point structure further comprises a guide port, the guide port is positioned at the joint of the needle seat of the microneedle and the substrate through hole, and the guide port is positioned on the circumferential side wall of the needle seat.

According to the invention, the stress structure point further comprises a guide port, the guide port is positioned at the joint of the needle seat and the substrate through hole, and the guide port is positioned on the substrate layer.

According to the invention, after the microneedle is pricked into the skin and the substrate layer is torn off, the microneedle and the through hole adjacent to the microneedle form a group of stress units, and at least one group of stress units are arranged on the substrate layer at intervals;

the basal layer and the micro-needle are separated by the stress point structure to form a crack, and the crack is intersected on the basal layer between the two adjacent groups of the stress units.

According to the invention, the microneedle sticker with the easily torn base comprises at least one microneedle unit, the microneedle unit comprises at least one first microneedle and at least one second microneedle which are arranged at intervals, the first microneedle is the microneedle provided with the fixing part, the second microneedle is the microneedle which is not provided with the fixing part, and the second microneedle is positioned on one side of the first microneedle which is not provided with the fixing part.

According to the invention, the microneedle patch with the easily torn base comprises a plurality of microneedle units, the microneedle units are arranged on the base layer at intervals in a multi-row and multi-column mode, and the fixing part on each first microneedle extends towards the same direction.

According to the invention, a plurality of the microneedle units are arranged at intervals in a staggered manner.

According to the invention, when the base layer is torn off after the micro-needle is pricked into the skin, the base layer and the cracks formed by the separation of the stress point structures of the micro-needle units are intersected at the gaps of two adjacent groups of micro-needle units.

According to the invention, the fracture formed by separating the base layer and the microneedle unit extends from the first microneedle to the second microneedle along the guide opening and extends along the circumferential side wall of the needle seat of the second microneedle so as to separate the second microneedle from the base layer.

According to the invention, the minimum length of the connecting line of the guide openings at two sides of the first microneedle is larger than the maximum length of the second microneedle in the connecting line direction of the guide openings.

According to the invention, the extension line of the guide port is tangent to or intersects with the circumferential side wall of the needle seat of the second microneedle.

According to the invention, the thickness of the joint of the substrate layer and the needle seat of the second micro-needle is smaller than that of the region of the substrate layer where the micro-needle is not arranged.

(III) advantageous effects

The utility model has the advantages that:

when the microneedle patch is used, the microneedle patch is pricked into skin, the basal layer is held by hand, and the basal layer is lifted along the direction of the side of the microneedle, which is provided with the bulge and is not provided with the bulge. Because the junction of micropin and stratum basale is equipped with the stress point structure that is used for tearing the separation with micropin and stratum basale, there is great stress concentration phenomenon in stress point structure department, when tearing off the stratum basale, the stratum basale and the critical stress that the micropin fracture was separated of stress point structure department are less, consequently can realize separating the stratum basale and the fracture of micropin in order to tear off the stratum basale under less external force.

The substrate layer and the microneedles are integrally formed, so that the microneedle patch can be conveniently formed and prepared.

Drawings

Fig. 1 is a schematic view of a microneedle patch with a substrate easy to tear according to the present invention;

fig. 2 is a schematic view of a microneedle of the microneedle patch with a base easy to tear according to the present invention, wherein the microneedle main body is a microneedle with a fan-shaped horizontal projection;

fig. 3 is an extension schematic diagram of a tearing crack when the microneedle with the easily torn substrate is attached to the torn substrate layer of the present invention;

FIG. 4 is a front view of FIG. 2;

FIG. 5 is a top view of FIG. 2;

FIG. 6 is a diagram showing the state of dissolution of the microneedle after it has been inserted into the skin;

fig. 7 is a schematic diagram of a microneedle of which the microneedle main body is a triangular pyramid in the microneedle patch with the easily torn substrate of the present invention;

FIG. 8 is a front view of FIG. 7;

fig. 9 is a schematic diagram of microneedles, in which the microneedle bodies in the substrate easy-to-tear microneedle patch of the present invention are rectangular pyramids;

FIG. 10 is a front view of FIG. 9;

fig. 11 is a schematic view of a microneedle unit disposed on a substrate layer;

FIG. 12 is a front view of FIG. 11;

fig. 13 is a schematic diagram illustrating the tearing crack extension when the microneedle array of the present invention is attached to the base layer (microneedle units are spaced in multiple rows and columns);

fig. 14 is a schematic diagram of the tearing crack extension when the microneedle with the easily torn substrate is attached to the torn substrate (the microneedle units are arranged at intervals in a staggered manner);

fig. 15 is a schematic view of a base peel-off microneedle patch with a guide opening disposed on a base layer.

[ description of reference ]

4: a first microneedle; 40: a second microneedle; 41: a microneedle body; 411: a needle tip; 412: a middle part; 413: a needle seat; 414: a guide port; 4141: a first incision line; 4142: a second cut line; 42: a protrusion; 421: a first protrusion; 422: a second protrusion; 423: a third protrusion;

5: a base layer; 51: a substrate through hole;

6: cracking; 60: an intersection point;

a: a junction;

t0: the state of the microneedles just after penetration into the skin;

t1: the state of the microneedle after being pricked into the skin for 20 minutes;

t2: the state of the microneedle after penetrating into the skin for 40 minutes;

t3: the state of the microneedle after 60 minutes of penetration into the skin;

x: the first microneedle is provided with a direction towards the side without the protrusion, or the first microneedle is provided with a direction towards the same microneedle unit with the protrusion side and the second microneedle extends.

Detailed Description

For a better understanding of the present invention, reference will now be made in detail to the present invention, examples of which are illustrated in the accompanying drawings. As used herein, the terms "upper", "lower", and the like are used with reference to the orientation of FIG. 4.

Example 1

The embodiment provides a substrate peel-off microneedle patch, which comprises a substrate layer 5 and at least one microneedle, wherein the at least one microneedle is arranged at the bottom of the substrate layer 5. The microneedles themselves carry the drug components and are dissolvable in the skin. Preferably, the substrate layer 5 and the microneedles are integrally formed to facilitate the preparation of the microneedle patch.

Further, referring to fig. 1-14, the microneedles include a first microneedle 4, and the first microneedle 4 includes a microneedle body 41. In the vertical direction, the microneedle body 41 includes a needle tip 411, a middle portion 412, and a needle seat 413 in this order. Hub 413 is connected to base layer 5. The periphery of the microneedle body 41 is provided with a fixing part with a non-smooth surface, wherein the fixing part comprises a part of the bulge 42 and/or the needle point 411 which circumferentially protrudes out of the needle seat 413, or any form of protrusion which is arranged on the microneedle body 41 and can be anchored in the skin after the microneedle penetrates into the skin. In this embodiment, at least one protrusion 42 is circumferentially disposed on the middle portion 412. The microneedle body 41 and the protrusion 42 are integrally formed by a mold, but may be prepared by 3D printing, centrifugation, pulling, or the like. The projections 42 are pyramid-shaped, and the projections 42 extend radially along the microneedle body 41, with tips away from the microneedle body 41.

Since, when the first microneedle 4 is positioned in the skin, it is necessary to consider whether the first microneedle 4 can remain in a desired position in the skin when it is completely dissolved, the holding force of the first microneedle 4 to the skin is increased by the above arrangement.

Specifically, the first microneedles 4 have the following advantages:

after the first microneedle 4 punctures and enters the skin, the part of the first microneedle 4 protruding out of the needle seat 413 through the bulge 42 and/or the needle point 411 is anchored in the skin, so that the holding force between the first microneedle 4 and the skin is increased, the first microneedle 4 is prevented from being separated from the skin due to the pushing of the skin elastic deformation, the continuous and accurate administration is realized, and the administration effect is ensured.

After pricking first micropin 4 into the skin during the use, in the part embedding skin that arch 42 and needle point 411 on first micropin 4 are outstanding in needle file 413, strengthen first micropin 4 and the power of grabbing of skin, thereby after first micropin 4 pricks the skin, when exerting external force and tearing and remove stratum basale 5, first micropin 4 still can the gomphosis in the skin and avoid being dragged out from the skin, realize that the stratum basale 5 is torn easily to the basement, comfort level and aesthetic property when improving the basement and tearing the micropin subsides and use easily, especially children, the pet, the condition that the stratum basale 5 was scratched or licked to the existence in the psychopath of using medicine, and avoid leading to first micropin 4 to drop.

The base easily tears the position that the micropin is pasted and is connected at base layer 5 and first micropin 4 and sets up stress point structure, and in this embodiment, stress point structure is including setting up the base through-hole 51 that sets up on base layer 5 and the arch 42 homonymy on first micropin 4 and set up. The maximum length of the base through hole 51 is greater than that of the first microneedle 4 along a direction parallel to a connecting line of the base layer 5 and two connecting points of the first microneedle 4, so that when the base layer 5 is torn off, tear-off cracks can extend around two sides of the first microneedle 4 and then intersect with each other. Preferably, the base through hole 51 is a major arc, and the projection of the first microneedle 4 on the base layer 5 is a minor arc.

As shown in fig. 1 to 14, when the microneedle patch is used, after the first microneedle 4 is inserted into the skin, the substrate layer 5 is held by hand, and the substrate layer 5 is lifted in a direction from the side of the first microneedle 4 where the protrusion 42 is provided to the side where the protrusion 42 is not provided. Because the stress point structure formed at the connection position of the substrate through hole 51 and the needle seat 413 of the first microneedle 4 has a large stress concentration phenomenon, when the substrate layer 5 is torn off, the critical stress of the substrate layer 5 at the stress point structure and the first microneedle 4 in fracture separation is small, so that the substrate layer 5 and the first microneedle 4 can be fractured and separated under the action of small external force to tear off the substrate layer 5. For the yields when improving the shaping of first micropin 4, adopt in the mould injection moulding liquid easily to tear the micropin with the shaping basement and paste when, set up protruding 42 one side drawing of patterns along first micropin 4 and do not set up protruding 42 one side to first micropin 4, easily tear the micropin with the basement and paste and the mould separation, guarantee that first micropin 4 is complete harmless.

In the process of tearing off the basal layer 5, the first microneedle 4 is clamped in the skin through the protrusion 42 due to the arrangement of the protrusion 42 on the first microneedle 4, the embedding resistance (clamping force) between the first microneedle 4 and the skin is more than the peeling force of the fracture separation of the basal layer 5 and the first microneedle 4, the first microneedle 4 is stably embedded in the skin, the maximum size of the basal through hole 51 is more than the maximum length of the first microneedle 4 along the direction parallel to the connecting line of two connecting points of the basal layer 5 and the first microneedle 4, and the tearing cracks generated after the fracture separation of the basal layer 5 and the first microneedle 4 at the stress point structure extend around two sides of the first microneedle 4 and intersect with each other, so that the basal layer 5 and the first microneedle 4 can be thoroughly separated, and the tearability of the basal layer 5 is improved. In this application, first micropin 4 pricks and to tear substrate layer 5 immediately after going into the skin, only retains first micropin 4 in the skin, and then has improved comfort level and aesthetic property that the substrate easily torn micropin subsides use, avoids children, pet, the condition that the psychopath used medicine in-process to have the scratching or lick substrate layer 5, and leads to first micropin 4 to drop.

In order to enhance the strength of the first microneedle 4 and reduce the resistance of the first microneedle 4 to penetrate into the skin, preferably, the middle part 412 of the microneedle body 41 is provided with the protrusion 42, and the protrusion 42 is located in the middle part 412 of the microneedle body 41, so that a weak area of the needle point 411 on the microneedle body 41 can be avoided, the strength of the first microneedle 4 is ensured, and the failure of the first microneedle 4 caused by the breakage of the needle point 411 due to insufficient strength when the first microneedle 4 penetrates into the skin is avoided. On the other hand, the protrusion 42 is disposed in the middle 412 of the microneedle body 41 to form a channel in the process of piercing and entering the skin by the needle point 411, and since there is no other structure on the needle point 411, the piercing resistance is small, and the skin recovery deformation has a certain hysteresis, so that the first microneedle 4 and the protrusion 42 can be guided to smoothly enter the skin, and the occurrence or probability of the problem that the protrusion 42 is broken in the process of piercing and entering the skin is avoided or reduced, thereby ensuring that the first microneedle 4 can be stably embedded in the skin due to the elasticity of the skin and the recovery characteristic after deformation after the first microneedle 4 completely enters the skin.

Preferably, the protrusion 42 extends from the needle tip 411 to the direction of the substrate layer 5 in the middle part 412, so that the protrusion 42 forms a barb-like structure, and the first microneedle 4 can be stably anchored in the skin, thereby increasing the holding force of the first microneedle 4 with the skin. Referring to fig. 2 and 4, an included angle α between the extending direction of the protrusion 42 and the axis (the vertical line passing through the needle point 411) of the microneedle body 41 is preferably 15 ° or more and 75 ° or less, and more preferably 30 ° or more and 60 ° or more, so that the protrusion 42 can be effectively inserted into the skin for the second time after the first microneedle 4 is inserted into the skin, thereby anchoring the skin between the microneedle body 41 and the protrusion 42, enhancing the grasping force of the first microneedle 4 with the skin, increasing the resistance between the first microneedle 4 and the skin, ensuring that the fitting resistance (grasping force) between the first microneedle 4 and the skin is greater than the peeling force of the base layer 5 and the first microneedle 4 which are broken and separated, and preventing the first microneedle 4 from being pulled out together by the base layer 5 and being separated from the skin when the base layer 5 is torn.

When contained angle alpha >75 when, first micropin 4 pricks the skin in-process resistance is big, the easy broken needle, and after first micropin 4 pricked the skin, because the skin has elasticity and rigidity simultaneously, first micropin 4 and the unable fine laminating of skin, the skin easily from micropin main part 41 with the arch 42 between the roll-off, the secondary of arch 42 in the skin is pricked the effect poor, the anchor effect of first micropin 4 in the skin is poor. When the included angle α is less than 15 °, the contact area between the microneedle body 41 and the protrusion 42 and the skin is too small, the first microneedle 4 has small resistance with the skin, and is easy to slide out of the skin, and the protrusion 42 cannot be inserted into the skin for the second time, so that the anchoring effect of the first microneedle 4 in the skin is poor.

Further, as shown in fig. 2 to 14, the microneedle body 41 may have various shapes including a cone having a fan shape in a horizontal projection, a cone having an elliptical fan shape in a horizontal projection, a triangular pyramid, a rectangular pyramid, and the like.

For better explanation, as an example, the following is a specific arrangement manner of the projections 42 provided on the microneedle main body 41 of several shapes in the first microneedle 4:

referring to fig. 2, 4-6, when the horizontal projection of the needle seat 413 of the first microneedle 4 is fan-shaped and the microneedle body 41 is a cone with the horizontal projection being fan-shaped: the protrusion 42 is located on the edge of the microneedle main body 41 connected with the tip of the fan-shaped plane, so that the resistance of the first microneedle 4 when penetrating into the skin is reduced, the shape of the skin in contact with the fan-shaped area after the first microneedle 4 penetrates into the skin is increased, the skin deformation of the edge contact area connected with the tip of the fan-shaped plane is smaller, the skin can be well attached to the protrusion 42 on the first microneedle 4, and the anchoring effect of the protrusion 42 and the skin is promoted.

Further, along the direction that the needle seat 413 extends to the needle point 411, the number of the protrusions 42 is at least 1, and preferably 2-3, and the protrusions 42 are sequentially arranged along the edge of the microneedle main body 41 connecting the fan-shaped plane tip. If only 1 protrusion 42 is provided, the first microneedle 4 cannot continuously maintain a stable skin gripping force with the skin as the first microneedle 4 penetrates the skin and the protrusion 42 is dissolved, and the first microneedle 4 is easily pushed out by the skin. While the greater the number of protrusions 42, the less the volume of a single protrusion 42, the more easily the protrusion 42 may be dissolved and lose its gripping force with the skin.

When the number of the protrusions 42 is more than 2, the horizontal projection areas and the volumes of the plurality of protrusions 42 are sequentially increased along the needle seat 413 of the first microneedle 4 toward the needle point 411, so as to increase and continuously realize the holding force between the first microneedle 4 and the skin.

It should be noted that, when the first microneedle 4 is provided with two protrusions 42 along the direction in which the needle seat 413 extends toward the needle tip 411, the protrusions 42 sequentially include a first protrusion 421 and a second protrusion 422. The projections 42 are shaped so as not to interfere with demolding. The method comprises the following specific steps:

the circumferential side wall of the first protrusion 421 extends vertically, or is disposed to be inclined toward the direction close to the microneedle main body 41, and the circumferential side wall of the second protrusion 422 extends vertically, or abuts against the circumferential side wall of the molding cavity of the mold, so as to prevent the first protrusion 421 from affecting the demolding of the second protrusion 422.

When the first microneedle 4 is provided with more than two protrusions 42 along the direction in which the needle seat 413 extends toward the needle tip 411, the protrusions 42 sequentially include a first protrusion 421, a second protrusion 422, other protrusions 42, and a third protrusion 423. The projections 42 are shaped so as not to interfere with demolding. The method specifically comprises the following steps:

the circumferential side wall of the first protrusion 421 extends vertically. The circumferential side walls of the second protrusion 422 and the other protrusions 42 located between the first protrusion 421 and the third protrusion 423 extend vertically or are disposed obliquely to a direction approaching the microneedle body 41. The circumferential side wall of the third protrusion 423 extends vertically or abuts against the circumferential side wall of the molding cavity of the mold. Through the arrangement, the influence of the bulges 42 on demoulding is avoided.

Preferably, in the direction in which the needle seat 413 extends towards the needle tip 411, the protrusion 42 sequentially comprises a first protrusion 421, a second protrusion 422 and a third protrusion 423, and the horizontal projection areas and volumes of the first protrusion 421, the second protrusion 422 and the third protrusion 423 are sequentially increased.

Preferably, the vertical distance H1 between the tip of the first protrusion 421 and the substrate layer 5 is 100 μm to 130 μm, and the height H1 from the base of the first protrusion 421 to the piercing tip is 30 μm; the vertical distance H2 between the tip of the second protrusion 422 and the substrate layer 5 is 250 μm to 350 μm, and the height H2 from the base of the second protrusion 422 to the piercing tip is 100 μm; the vertical distance H3 between the tip of the third protrusion 423 and the base layer 5 is 250mm to 450mm, and the height H3 from the base of the third protrusion 423 to the puncture tip is 50 μm. Referring to fig. 4, it is preferable that an angle between an extending direction of the first protrusion 421 and an axis of the microneedle body 41 (a vertical line passing through the needle tip 411) is 45 °, an angle between an extending direction of the second protrusion 422 and an axis of the microneedle body 41 (a vertical line passing through the needle tip 411) is 30 °, and an angle between an extending direction of the third protrusion 423 and an axis of the microneedle body 41 (a vertical line passing through the needle tip 411) is 60 °. Because the skin has elasticity and rigidity, the first microneedle 4 cannot be tightly attached to the skin, the extending direction of the third protrusion 423 forms an included angle of 60 degrees with the axis of the microneedle main body 41, the height h3 from the base to the puncture tip is 50 micrometers, a certain gap exists between the first microneedle 4 and the skin after being inserted into the skin, and the secondary insertion effect between the first protrusion 421 and the skin is weaker; however, the included angle between the extending direction of the second protrusion 422 and the axis of the microneedle main body 41 is 30 °, the height h2 from the base to the puncture tip is 100 μm, the gap between the second protrusion 422 and the skin is relatively small, the fitting degree is relatively good, when the skin recovers deformation and pushes out the first microneedle 4 in advance, the second protrusion 422 is easy to prick into the skin for the second time, the resistance between the first microneedle 4 and the skin is enhanced, so that the first microneedle 4 can be stopped in the skin, and after the first microneedle 4 is pricked into the skin and the skin recovers a certain deformation, the gap between the skin and the third protrusion 423 and the first protrusion 421 on the first microneedle 4 is relatively reduced, the fitting degree is good, the second pricking into the skin can be better realized, and the first microneedle 4 is stably embedded into the skin. In addition, since the first protrusion 421 is located in the stratum corneum layer of the skin after the first microneedle 4 is inserted into the skin, the dissolution rate is slow, and thus the volume of the first protrusion 421 is not suitable to be too large.

Specifically, the utility model discloses the crushing force of first micropin 4 is that the biggest resistance value that can bear when first micropin 4 pricks into skin is greater than or equal to 0.1N, and first micropin 4 can be complete pierce skin smoothly. The pulling force of the first microneedle 4 after being pricked into the skin, namely the holding force between the first microneedle 4 and the skin after being pricked into the skin, is not less than 0.06N, and the tearing and separating force of the substrate layer 5 and the first microneedle 4 is less than 0.06N, so that when the substrate layer 5 is torn and removed after the first microneedle 4 is pricked into the skin, the first microneedle 4 can be stably embedded into the skin.

Referring to fig. 6, since the projections 42 are provided so that the first microneedles 4 penetrate into the skin and the first projections 421 are located in the stratum corneum after penetrating into the skin, it is generally considered that the moisture content of the skin in the vicinity of the stratum corneum is low, and therefore, the first projections 421 fitted thereto are dissolved at a low speed, and the first projections 421 provide a skin gripping force for a longer period of time even though the volume thereof is minimized. The second projections 422 and the third projections 423 are fitted under the stratum corneum, where the skin water content is high, the dissolution rate of the second projections 422 and the third projections 423 is high, and the dissolution time of the third projections 423 is longer than that of the second projections 422 because the volume of the second projections 422 is smaller than that of the third projections 423. The skin bounce force is strongest at an initial stage after the first microneedle 4 enters the skin, and the second protrusion 422 and the third protrusion 423 can provide a stronger skin holding force to offset the skin bounce force, so that the first microneedle 4 is stably embedded in the skin. As time passes, the microneedle body 41, the second protrusion 422, and the third protrusion 423 are dissolved, and the grasping force of the first microneedle 4 to the skin is weakened, at which time the deformation amount of the skin is reduced and the repulsive force is weakened. When the second protrusion 422 is substantially completely dissolved, the third protrusion 423 can still exert a certain grasping force even if the second protrusion is not completely dissolved, and the first protrusion 421 has a smaller degree of dissolution, so that the first protrusion 421 and the third protrusion 423 can still provide sufficient skin grasping force to ensure that the first microneedle 4 is stably embedded in the skin, and is prevented from being pushed out of the skin.

Example 2

The difference between this embodiment and embodiment 1 is that the microneedle body 41 is a cone with a horizontal projection in the shape of an elliptical sector: the protrusion 42 is located on an edge of the microneedle body 41 connecting the tips of the bottom surfaces of the elliptical sectors, and is located on the short axis side of the horizontal projection of the microneedle body 41.

Compared with the embodiment 1, the first microneedle 4 of the present embodiment has an increased volume, so as to increase the drug loading capacity of the first microneedle 4, and meet the requirements of different drugs for dosage forms.

Example 3

Referring to fig. 7 to 8, the present embodiment is different from embodiment 1 in that the microneedle body 41 is a triangular pyramid: the projections 42 are located on the edges of the microneedle body 41 to reduce resistance when the first microneedles 4 penetrate the skin. When one protrusion 42 is provided, the protrusion 42 is located on an edge perpendicular to the base layer 5 to further reduce resistance when the first microneedles 4 penetrate the skin.

Example 4

Referring to fig. 9 to 10, the present embodiment is different from embodiment 1 in that the microneedle body 41 is a rectangular pyramid: the projections 42 are located on the edges of the microneedle body 41 to reduce resistance when the first microneedles 4 penetrate the skin. When one projection 42 is provided, the projection 42 is positioned on an edge perpendicular to the base layer 5 to further reduce the resistance of the first microneedle 4 to penetrate the skin.

Example 5

Referring to fig. 2, 3 and 5, the present embodiment is different from embodiment 1 in that the stress point structure includes a substrate through hole 51 disposed on the substrate layer 5 and a guide port 414 disposed on the needle seat 413 of the first microneedle 4. The guide ports 414 are located at the junctions of both sides of the microneedle mount 413 and the base through hole 51, and the guide ports 414 are located on the circumferential side wall of the mount 413. The first microneedle 4 and the substrate through hole 51 adjacent to the first microneedle form a group of stress units, and at least one group of stress units are arranged on the substrate layer 5 at intervals, as shown in fig. 3, when the first microneedle 4 is pricked into the skin and the substrate layer 5 is torn and removed along the X direction, a tearing external force acts on the substrate layer 5 and is transmitted to the guide port 414 through the substrate layer 5. The guide port 414 reduces the critical separation force between the substrate layer 5 and the needle seat 413 of the first microneedle 4, and when the substrate layer 5 is attached and torn off by using the substrate peel-off microneedle, the guide port 414 can guide a tear-off crack between the substrate layer 5 and the first microneedle 4 to extend along the crack 6. Because the protrusion 42 arranged on the first microneedle 4 enables the first microneedle 4 to be stably embedded in the skin, in the process of tearing off the substrate layer 5, and under the action of the resultant force of the external force and the embedding force of the first microneedle 4 and the skin, the crack 6 generated between the substrate layer 5 and the first microneedle 4 can be accurately extended along the circumferential side wall of the needle seat 413 of the first microneedle 4 through the guide port 414, and is converged into the intersection point 60 on the substrate layer 5 between the two adjacent groups of stress units, so that the first microneedle 4 and the substrate layer 5 are completely separated.

Example 6

The difference between this embodiment and embodiment 5 is that the base peel-off microneedle patch includes at least one microneedle unit, and each microneedle unit includes at least one first microneedle 4 and a second microneedle 40 which are arranged at intervals, as shown in fig. 11 to 14. The first microneedles 4 are microneedles provided with the projections 42, and the second microneedles 40 are microneedles not provided with the projections 42. In the microneedle unit of this embodiment, the second microneedle 40 without the protrusion 42 can increase the drug loading capacity of the microneedle patch, and the first microneedle 4 with the protrusion 42 can increase the grasping force with the skin, so as to meet the requirements of the substrate with large drug loading capacity and stable grasping with the skin for easily tearing the microneedle patch.

Specifically, on the base layer 5, the second microneedle 40 is located on the side of the first microneedle 4 where the protrusion 42 is not located, and the minimum length of the connecting line of the guide openings 414 on both sides of the first microneedle 4 is greater than the maximum length of the second microneedle 40 in the direction parallel to the connecting line of the two guide openings 414. The guide ports 414 are located on the circumferential side wall of the needle seat 413 of the first microneedle 4, and the extension lines of the guide ports 414 on both sides of the first microneedle 4 intersect or are tangent with the circumferential side wall of the needle seat 413 of the second microneedle 40. Preferably, the extension lines of the guide ports 414 on both sides of the first microneedle 4 are tangent to the circumferential side wall of the needle seat 413 of the second microneedle 40. Preferably, the microneedle body 41 is arranged in a fan-shaped horizontal projection, the joints between the guide ports 414 on the two sides of the needle seat 413 and the needle seat 413 are A, the included angle between the two joints A and the connection line of the circle center of the first microneedle 4 is 120-150 degrees, the radius of the first microneedle 4 is R, the radius of the second microneedle 40 is R, and then R is greater than or equal to 0.17R and less than or equal to 0.59R.

When a plurality of microneedle units are attached to the base peel-off microneedle patch, the microneedle units are disposed on the base layer 5 at intervals in a plurality of rows and columns, and the projections 42 of the first microneedles 4 extend in the same direction, as shown in fig. 13. After the micro-needle penetrates the skin, the base layer 5 is torn off along the direction that the first micro-needle 4 is provided with the protrusion 42 and the direction that the second micro-needle 40 is arranged in the same micro-needle unit is the X direction, and the crack 6 extends along the extending direction of the joint A, and is intersected at the gap between the joint A and the adjacent micro-needle unit to form an intersection point 60. Along the direction of connecting the circle centers of the first microneedle 4 and the second microneedle 40, the distance from the circle center of the first microneedle 4 of the microneedle unit to the circle center of the first microneedle 4 of the adjacent microneedle unit is L, L is not less than 3R and not more than 6R, so that the junction 60 formed by the crack 6 is positioned between the two microneedle units, the substrate layer 5 can be effectively torn off, and the microneedle units are stably embedded in the skin and are not dragged by the substrate layer 5 to leave the skin, thereby realizing effective and accurate administration. In addition, the substrate layer 5 has sufficient strength, the microneedle which is easy to tear off the substrate is pasted on the skin, and after the microneedle is pricked into the skin, the strength of the needleless region (i.e. the region without the microneedle) of the substrate layer 5 is sufficient to tear off the substrate layer 5 at one time when the substrate layer 5 is torn off, so that the substrate layer 5 can be effectively prevented from being torn off for many times due to the breakage of the needleless region of the substrate layer 5.

Furthermore, when the microneedle is prepared, the injection amount of the base layer 5 raw material liquid is controlled, after the second microneedle 40 is dried, the thickness of the base layer 5 at the connection part with the needle base 413 is smaller than that of the base layer 5 of the needle-free region due to drying and shrinkage of the raw material liquid, so when the second microneedle 40 is torn off after being pricked into the skin, although the second microneedle 40 is not provided with the protrusion 42, the first microneedle 4 is stably embedded into the skin because the protrusion 42 is provided on the first microneedle 4, and the crack 6 generated when the base layer 5 is torn off surrounds the microneedle unit and is intersected with the gap of the adjacent microneedle unit, so that the second microneedle 40 can be stably embedded into the skin, the thickness of the base layer 5 at the connection part with the second microneedle 40 is small, the base layer 5 can be separated along the circumferential side wall of the second microneedle 40, and finally the stable embedding of the microneedle unit into the skin is realized, and effective and accurate administration is realized.

Referring to table 1, embodiment 5 and embodiment 6, when the base easily-torn microneedle patch is provided with the first microneedle 4 or the microneedle unit, the grasping force of the first microneedle 4 or the microneedle unit and the skin is improved through the protrusion 42 on the first microneedle 4, and when the base easily-torn microneedle patch is prevented from being attached to the skin and the base layer 5 is torn immediately, the first microneedle 4 or the second microneedle 40 is taken out by the base layer 5, so that the time required by the base layer 5 when the microneedle patch is attached to the skin in use is greatly shortened, the use comfort of the microneedle patch is further improved, and the microneedle patch is convenient to use by being sensitive to the base layer 5 or by an infant.

TABLE 1

Example 7

The difference between this embodiment and embodiment 6 is that the microneedle units are arranged at intervals, as shown in fig. 14, the density of the microneedle units in the microneedle patch is increased, and the drug loading of the microneedle patch is increased.

Example 8

As shown in fig. 15, the present embodiment is different from embodiment 5 in that the stress point structure includes a base through hole 51 disposed on the base layer 5 and a guide port 414 disposed at a junction of the needle seat 413 of the first microneedle 4 and the base layer 5, and the guide port 414 is located on the base layer 5. A first incision line 4141 and a second incision line 4142 which are communicated with the base through hole 51 are arranged on the base layer 5 near the connection part of the base through hole 51 and the needle holder 413, and a guide port 414 is formed in a base area surrounded by the base through hole 51, the first incision line 4141 and the second incision line 4142. The first incision line 4141 has one end communicating with the substrate through-hole 51 and the other end communicating with the second incision line 4142. The second cut line 4142 forms an included angle with the first cut line 4141, so that the extension lines of the second cut lines 4142 at both sides of the needle seat 413 can intersect on the substrate layer 5 between the stress unit and the adjacent stress unit.

After the first microneedle 4 of the substrate easy-to-tear microneedle patch is pricked into the skin, the substrate layer 5 is torn and removed along the X direction, and tearing external force acts on the substrate layer 5 and is transmitted to the guide port 414 through the substrate layer 5. The guide port 414 reduces the critical separation force between the substrate layer 5 and the needle seat 413 of the first microneedle 4, and when the substrate layer 5 is attached and torn off by using the substrate peel-off microneedle, the guide port 414 can guide a tear-off crack between the substrate layer 5 and the first microneedle 4 to extend along the second incision line 4142 and meet with the substrate layer between two adjacent stress units.

While embodiments of the present invention have been shown and described, it is to be understood that the above embodiments are exemplary and should not be construed as limiting the present invention, and that modifications, alterations, substitutions and variations may be made to the above embodiments by those of ordinary skill in the art without departing from the scope of the present invention.

Claims (17)

1. The microneedle patch with the easily torn substrate is characterized by comprising a substrate layer (5) and microneedles arranged on the substrate layer (5), wherein each microneedle comprises a microneedle main body (41) and at least 1 fixing part arranged on the microneedle main body (41);

the joint of the microneedle and the substrate layer (5) is provided with a stress point structure for tearing and separating the microneedle and the substrate layer (5);

the substrate layer (5) and the micro-needle are of an integrally formed structure.

2. The substrate peel-off microneedle patch according to claim 1, wherein the fixing portion comprises a protrusion (42), and an included angle between the extending direction of the protrusion (42) and the axis of the microneedle main body (41) is α, and is greater than or equal to 15 ° and less than or equal to 75 °.

3. The substrate peel-off microneedle patch according to claim 2, wherein an included angle between an extending direction of said protrusion (42) and an axis of said microneedle body (41) is α,30 ° α ≦ 60 °.

4. The substrate peel-off microneedle sticker according to any one of claims 2 to 3, wherein when the number of the protrusions (42) is greater than or equal to 2 along the direction in which the microneedle seat (413) of the microneedle extends toward the needlepoint (411) of the microneedle, the horizontal projection areas and the volumes of the plurality of protrusions (42) are sequentially increased.

5. The substrate microneedle sticker according to claim 1, wherein the stress point structure comprises a substrate through hole (51) disposed on the substrate layer (5) and on the same side as the fixing portion on the microneedle.

6. The substrate peel-off microneedle sticker according to claim 5, wherein the stress point structure further comprises a guide port (414), the guide port (414) is located at a joint of a needle seat (413) of the microneedle and the substrate through hole (51), and the guide port (414) is located on a circumferential side wall of the needle seat (413).

7. The substrate peel-off microneedle sticker according to claim 5, wherein the stress point structure further comprises a guide port (414), the guide port (414) is located at a joint of a microneedle needle seat (413) and the substrate through hole (51), and the guide port (414) is located on the substrate layer (5).

8. The microneedle patch according to any one of claims 5-7, wherein after said microneedle is inserted into the skin and said substrate layer (5) is removed, said microneedle and its adjacent substrate through hole (51) form a set of stress units, and at least one set of said stress units are spaced on said substrate layer (5);

the basal layer (5) and the micro-needle are separated by the stress point structure to form a crack (6), and the crack (6) is intersected on the basal layer (5) between the two adjacent groups of stress units.

9. The substrate peel-off microneedle sticker according to claim 6 or 7, wherein the maximum length of the substrate through hole (51) is greater than the maximum length of the first microneedle (4) in a direction parallel to a line connecting two connection points of the substrate layer (5) and the first microneedle (4).

10. The substrate easy-tear microneedle patch according to claim 6 or 7, wherein the substrate easy-tear microneedle patch comprises at least one microneedle unit, the microneedle unit comprises at least one first microneedle (4) and at least one second microneedle (40) which are arranged at intervals, the first microneedle (4) is a microneedle provided with the fixing portion, the second microneedle (40) is a microneedle which is not provided with the fixing portion, and the second microneedle (40) is located on one side of the first microneedle (4) which is not provided with the fixing portion.

11. The substrate peel-off microneedle patch according to claim 10, wherein the substrate peel-off microneedle patch comprises a plurality of microneedle units, the microneedle units are arranged on the substrate layer (5) at intervals in a multi-row and multi-column manner, and the fixing portions of the first microneedles (4) extend in the same direction.

12. The substrate peel-off microneedle patch according to claim 10, wherein a plurality of said microneedle units are arranged at intervals.

13. The microneedle patch according to claim 10, wherein when the microneedle patch penetrates into the skin and then tears off the substrate layer (5), the substrate layer (5) and the microneedle unit are intersected at the gap between two adjacent groups of microneedle units by the crack (6) formed by the separation of the stress point structures.

14. The substrate peel off microneedle sticker according to claim 13, wherein the fracture (6) formed by the separation of the substrate layer (5) and the microneedle unit extends from the first microneedle (4) to the second microneedle (40) along the guide opening (414) and extends along a circumferential side wall of the needle seat (413) of the second microneedle (40) to separate the second microneedle (40) from the substrate layer (5).

15. The substrate peel off microneedle patch according to claim 13, wherein a minimum length of a line connecting the guide openings (414) on both sides of the first microneedle (4) is greater than a maximum length of the second microneedle (40) in a direction of the line connecting the guide openings (414).

16. The basal peel off microneedle sticker according to claim 13, wherein an extension line of the guide port (414) is tangent to or intersects a circumferential side wall of the needle seat (413) of the second microneedle (40).

17. The substrate peel-off microneedle sticker according to claim 13, wherein the thickness of the junction of the substrate layer (5) and the needle seat (413) of the second microneedle (40) is smaller than the thickness of the region of the substrate layer (5) where the microneedle is not disposed.

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