CN114209975A - Microneedle patch with easily torn substrate - Google Patents
Microneedle patch with easily torn substrate Download PDFInfo
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- CN114209975A CN114209975A CN202111532216.9A CN202111532216A CN114209975A CN 114209975 A CN114209975 A CN 114209975A CN 202111532216 A CN202111532216 A CN 202111532216A CN 114209975 A CN114209975 A CN 114209975A
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- microneedle
- substrate
- skin
- substrate layer
- protrusion
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/003—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles having a lumen
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0046—Solid microneedles
Abstract
The invention relates to a microneedle sticker with a easily torn substrate, which comprises the substrate layer and microneedles arranged on the substrate layer, wherein each microneedle comprises a microneedle main body and at least 1 fixing part arranged on the microneedle main body. The connection of the micro-needle and the substrate layer is provided with a stress point structure for tearing and separating the micro-needle and the substrate layer. The beneficial effects are that, 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.
Description
Technical Field
The invention relates to the technical field of microneedles, in particular to a microneedle patch with an easily torn substrate.
Background
In recent centuries, metal injection needles have been widely used in the medical industry as the main drug injection device, but the pain and fear of using 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 cannot 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 approaches:
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 way is: 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.
Disclosure of Invention
Technical problem to be solved
In view of the above disadvantages and shortcomings of the prior art, the invention provides a microneedle patch with an easily torn substrate, which solves the technical problems that the substrate layer is difficult to tear off from the microneedle when the existing microneedle patch is used, and the time required for tearing off the substrate layer after the microneedle is dissolved is long.
(II) technical scheme
In order to achieve the purpose, the invention adopts the main technical scheme that:
the embodiment of the invention provides a microneedle sticker with an easily torn substrate, which comprises a substrate layer and microneedles arranged on the substrate layer, wherein each microneedle comprises a microneedle main body and at least 1 fixing part arranged on the microneedle main body;
the connection of the micro-needle and the substrate layer is provided with a stress point structure for tearing and separating the micro-needle and the substrate layer.
According to the invention, the stress point structure comprises a substrate through hole arranged on the substrate 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 through hole of the substrate, 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 through hole of the substrate, and the guide port is positioned on the substrate layer.
According to the invention, the fixing part comprises a bulge, the extending direction of the bulge forms an included angle alpha with the axis of the microneedle main body, and the alpha is more than or equal to 15 degrees and less than or equal to 75 degrees.
According to the invention, the included angle between the extending direction of the bulge 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 invention, when the number of the protrusions is larger than or equal to the number of the protrusions along the direction in which the needle base of the microneedle extends to the needle tip, the horizontal projection areas and the volumes of the plurality of protrusions are sequentially increased.
According to the invention, after the microneedle is pricked into the skin and the basal layer is torn off, the microneedle and the through hole of the adjacent basal layer are a group of stress units, and at least one group of stress units are arranged on the basal 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 stress units.
According to the invention, the microneedle sticker with the easily torn substrate 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 a microneedle with a fixing part, the second microneedle is a microneedle without a fixing part, and the second microneedle is positioned on one side of the first microneedle without a fixing part.
According to the invention, when the stratum basale is torn off after the microneedle is pricked into the skin, the fracture formed by the separation of the stratum basale and the microneedle unit by the stress point structure is intersected at the gap of the two adjacent groups of microneedle units.
According to the invention, the fracture formed by the separation of the substrate layer and the microneedle unit extends from the first microneedle to the second microneedle along the guide port and extends along the circumferential side wall of the needle seat of the second microneedle so as to separate the second microneedle from the substrate layer.
According to the present invention, the minimum length of the leading edge line on both sides of the first microneedle is longer than the maximum length of the second microneedle in the leading edge line direction.
According to the invention, the extension line of the guide port is tangent to or intersected with the circumferential side wall of the needle seat of the second microneedle.
According to the invention, the microneedle sticker with the easily torn substrate comprises a plurality of microneedle units, the microneedle units are arranged on the substrate layer at intervals in a multi-row and multi-column mode, and the fixing part on each first microneedle extends in the same direction.
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 without the micro-needle.
According to the present invention, a plurality of microneedle units are arranged at intervals.
(III) advantageous effects
The invention has the beneficial effects that:
when the microneedle patch is used, the microneedle patch is pricked into skin, and then the substrate layer is held by hand, and is lifted along the direction from one side of the microneedle setting fixing part to the side without the fixing part. 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.
Drawings
Fig. 1 is a schematic view of a substrate peel-off microneedle patch of the present invention;
fig. 2 is a schematic view of a microneedle of the substrate easy-tear microneedle patch of the present invention, in which a microneedle main body is a microneedle with a fan-shaped horizontal projection;
FIG. 3 is a schematic diagram illustrating the extension of a tear-off crack when a microneedle of the present invention is attached to a substrate;
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 substrate easy-tear microneedle patch of the invention;
FIG. 8 is a front view of FIG. 7;
fig. 9 is a schematic diagram of microneedles in which microneedle bodies are rectangular pyramids in the base peel-off microneedle patch of the present invention;
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 extension of a tearing crack when the base-tearable microneedle is attached to a torn base layer (microneedle units are spaced in multiple rows and multiple columns);
fig. 14 is a schematic diagram illustrating the extension of a tearing crack when the substrate-tearable microneedle is attached to the torn substrate layer (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;
table 1 is a table for comparing the quantity of microneedles retained on the basal layer when the microneedle patch is attached to the skin and the basal layer is torn off immediately when the microneedle patch is used in different embodiments.
[ 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: a crack; 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 20 minutes of penetration into the skin;
t2: the state of the microneedle after being pricked 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 the purpose of better explaining the present invention and to facilitate understanding, the present invention will be described in detail by way of specific embodiments with reference to 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 soluble in the skin.
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 holder 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 gets into the skin, the part that first microneedle 4 stands out in the needle file 413 through protruding 42 and/or needle point 411 anchors in the skin, has increased the power of grabbing of first microneedle 4 and skin, prevents that first microneedle 4 from breaking away from the skin because of skin elastic deformation pushes away, realizes lasting, accurate dosing to guarantee the effect of dosing.
After pricking skin with first micropin 4 during the use, protruding 42 and needle point 411 on first micropin 4 are outstanding in the partial embedding skin of needle file 413, strengthen first micropin 4 and the power of grabbing of skin, thereby after first micropin 4 pricks skin, exert external force and tear when getting rid of stratum basale 5, first micropin 4 still can the gomphosis in skin and avoid being dragged out from the skin, realize that the basement easily tears the micropin subsides and tear stratum basale 5 immediately, improve comfort level and aesthetic property when the basement easily tears the micropin subsides use, especially children, the pet, there is the condition of scratching or licking stratum basale 5 in the psychiatric patient uses the medicine in-process, 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 substrate layer 5, the first microneedle 4 is provided with the bulge 42, so that the first microneedle 4 is held in the skin through the bulge 42, the embedding resistance (holding force) between the first microneedle 4 and the skin is more than the peeling force of the fracture separation of the substrate layer 5 and the first microneedle 4, the first microneedle 4 is stably embedded in the skin, the maximum size of the substrate through hole 51 is larger than the maximum length of the first microneedle 4 along the direction parallel to the connecting line of two connecting points of the substrate layer 5 and the first microneedle 4, the tearing cracks generated after the fracture separation of the substrate layer 5 and the first microneedle 4 at the stress point structure extend around two sides of the first microneedle 4 and then intersect with each other, the substrate layer 5 and the first microneedle 4 can be thoroughly separated, and the tearing property of the substrate layer 5 is improved. In this application, first micropin 4 pricks into and can tear stratum basale 5 immediately after the skin, only leaves first micropin 4 in the skin, and then has improved comfort level and the aesthetic property that the stratum basale easily tears the micropin and pastes the use, avoids children, pet, the condition that the patient of mental disease used the in-process to have the scratching or lick stratum basale 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 of the microneedle body 41 (a vertical line passing through the needle point 411) is preferably 15 ° or more and 75 ° or less, and more preferably 30 ° or more and 60 ° or less, so that after the first microneedle 4 is inserted into the skin, the protrusion 42 can be inserted into the skin for a second time, thereby anchoring the skin between the microneedle body 41 and the protrusion 42, enhancing the grasping force of the first microneedle 4 and 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 substrate layer 5 and the first microneedle 4 when the substrate layer 5 is torn off, and preventing the first microneedle 4 from being pulled out together by the substrate layer 5 and being separated from the skin.
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-shaped horizontal projection, a cone having an elliptical fan-shaped 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 will 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 specifically comprises the following 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 projections 422 and the other projections 42 located between the first projections 421 and the third projections 423 extend vertically or are disposed obliquely to a direction close to 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. By the arrangement, the influence of the protrusions 42 on demolding 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 perpendicular 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 puncture 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, preferably, 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 included angle between the extending direction of the third protrusion 423 and the axis of the microneedle body 41 is 60 degrees, 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 pricked into the skin, and the secondary pricking effect between the first protrusion 421 and the skin is weak; however, the included angle between the extending direction of the second protrusion 422 and the axis of the microneedle body 41 is 30 degrees, 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 extrudes 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 stay in the skin, and after the first microneedle 4 pricks into the skin and the skin recovers 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 crushing force of the first microneedle 4, namely the maximum resistance value which can be borne by the first microneedle 4 when the first microneedle 4 penetrates into the skin, is not less than 0.1N, and the first microneedle 4 can completely and smoothly penetrate into the skin. 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 holding 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 the edge of the microneedle body 41 connecting the tip of the bottom surface of the elliptical sector, 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 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 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 substrate layer 5, the second microneedle 40 is located on one side of the first microneedle 4 without the protrusion 42, 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 along the direction parallel to the connecting line of the two guide openings 414. The guide port 414 is 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 is pricked into the skin, the substrate layer 5 is torn off along the direction that the first micro-needle 4 is provided with the bulge 42 and the second micro-needle 40 is arranged in the same micro-needle unit, namely 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.
Further, when preparing the microneedles, the injection amount of the base layer 5 raw material liquid is controlled so that the second microneedles 40 shrink due to drying of the raw material liquid after drying, the thickness of the base layer 5 at the connection with the needle holder 413 is smaller than the thickness of the base layer 5 of the needle-free region, so that when the base layer 5 is torn off after the microneedle is inserted into the skin, although the second microneedle 40 is not provided with the projection 42, since the first microneedle 4 is provided with the projection 42, the first microneedle 4 is stably fitted to the skin, and the cracks 6 generated when the substrate layer 5 is torn off surround the microneedle units and are intersected with the gaps of the adjacent microneedle units, so that the second microneedles 40 can be stably embedded in the skin, the thickness of the substrate layer 5 connected with the second microneedle 40 is small, and the substrate layer 5 can be separated along the circumferential side wall of the second microneedle 40, so that the microneedle unit is stably embedded in the skin, and effective and accurate drug delivery is realized.
Referring to table 1, embodiment 5 and embodiment 6, when the base easily tears the microneedle and pastes and set up first microneedle 4 or microneedle unit, the arch 42 on first microneedle 4 has improved the power of grabbing of first microneedle 4 or microneedle unit and skin, avoid the base easily to tear the microneedle and paste and attach behind the skin and tear basal layer 5 immediately, first microneedle 4 or second microneedle 40 are taken out by basal layer 5, the required time when basal layer 5 is attached to the skin when microneedle pastes the use has been shortened by a wide margin, and then the comfort in use of microneedle subsides has been improved, be convenient for to use by basal layer 5 sensitive or 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 base layer 5 between the stress unit and the adjacent stress unit.
After the first microneedle 4 to which the substrate easy-to-tear microneedle patch is stuck is pricked into the skin, when the substrate layer 5 is torn and removed along the X direction, 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.
Although embodiments of the present invention have been shown and described above, it should be understood that the above embodiments are illustrative and not restrictive, and that those skilled in the art may make changes, modifications, substitutions and alterations to the above embodiments without departing from the scope of the present invention.
Claims (16)
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 connection part of the micro-needle and the substrate layer (5) is provided with a stress point structure for tearing and separating the micro-needle and the substrate layer (5).
2. 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.
3. The substrate peel-off microneedle sticker according to claim 2, 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).
4. The peel-off base microneedle patch according to claim 2, wherein the stress structure point further comprises a guide port (414), the guide port (414) is located at a junction of the needle seat (413) and the base through hole (51), and the guide port (414) is located on the base layer (5).
5. The substrate peel-off microneedle patch according to any one of claims 1 to 4, 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 body (41) is α, 15 ° or more and 75 ° or less.
6. The substrate peel-off microneedle patch according to claim 5, wherein an included angle between the extending direction of the protrusion (42) and the axis of the microneedle body (41) is α, and 30 ° α or more and 60 ° or less.
7. The substrate peel-off microneedle sticker according to claim 6, 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), the horizontal projection areas and the volumes of the plurality of protrusions (42) are sequentially increased.
8. The substrate peel-off microneedle patch according to any one of claims 2 to 4, wherein after the microneedles are inserted into the skin and the substrate layer (5) is peeled off, the microneedles and the through holes (51) adjacent to the substrate are a group of stress units, and at least one group of the stress units are arranged on the substrate layer (5) at intervals;
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 easy-tear microneedle patch according to claim 3 or 4, 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.
10. The substrate peel-off microneedle sticker according to claim 9, wherein when the microneedle unit is torn off after penetrating into the skin, the substrate layer (5) and the microneedle unit meet at a gap between two adjacent groups of microneedle units through a crack (6) formed by separating the microneedle unit through the stress point structure.
11. The substrate peel-off microneedle sticker according to claim 10, 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).
12. The substrate peel-off microneedle patch according to claim 11, wherein a minimum length of a connecting line of 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 connecting line of the guide openings (414).
13. The basal peel-off microneedle sticker according to claim 10, wherein an extension line of the guide port (414) intersects or is tangent to a circumferential side wall of the needle seat (413) of the second microneedle (40).
14. The substrate peel-off microneedle patch according to claim 13, 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.
15. The substrate peel-off microneedle sticker according to claim 14, 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.
16. The substrate peel-off microneedle patch according to claim 10, wherein a plurality of said microneedle units are arranged at intervals.
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| CN202111532216.9A CN114209975B (en) | 2021-12-14 | 2021-12-14 | Microneedle patch with easily torn substrate |
| PCT/CN2022/137461 WO2023109633A1 (en) | 2021-12-14 | 2022-12-08 | Microneedle patch, microneedle mold and manufacturing method |
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| CN202111532216.9A CN114209975B (en) | 2021-12-14 | 2021-12-14 | Microneedle patch with easily torn substrate |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| WO2023109633A1 (en) * | 2021-12-14 | 2023-06-22 | 优微（珠海）生物科技有限公司 | Microneedle patch, microneedle mold and manufacturing method |
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