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CN117797393A - High-strength soluble microneedle - Google Patents

High-strength soluble microneedle Download PDF

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Publication number
CN117797393A
CN117797393A CN202311867843.7A CN202311867843A CN117797393A CN 117797393 A CN117797393 A CN 117797393A CN 202311867843 A CN202311867843 A CN 202311867843A CN 117797393 A CN117797393 A CN 117797393A
Authority
CN
China
Prior art keywords
needle
tip
needle tip
high strength
skin
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202311867843.7A
Other languages
Chinese (zh)
Inventor
李成国
冷钢
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Youwe Zhuhai Biotechnology Co ltd
Original Assignee
Youwe Zhuhai Biotechnology Co ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Youwe Zhuhai Biotechnology Co ltd filed Critical Youwe Zhuhai Biotechnology Co ltd
Priority to CN202311867843.7A priority Critical patent/CN117797393A/en
Publication of CN117797393A publication Critical patent/CN117797393A/en
Pending legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • 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
    • A61M2037/0007—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
    • 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
    • A61M2037/0023—Drug applicators using microneedles
    • 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
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/04—Skin

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Dermatology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

The invention belongs to the field of medical treatment and cosmetology, and discloses a high-strength soluble microneedle which comprises a substrate and a plurality of needle bodies distributed on the substrate, wherein each needle body comprises a needle tip part, the outer surface of each needle tip part is a smooth curved surface, the cross section of each needle tip part is circular, the diameter of each needle tip part gradually becomes smaller from bottom to top until the diameter of each needle tip part is zero, and the tangential inclination angle of the outer surface of each needle tip part gradually becomes smaller from bottom to top. The needle body structure of the microneedle combines with the hydrodynamic principle, the resistance when penetrating into the skin is reduced, the outer surface of the needle tip is a smooth curved surface, the cross section is circular, the diameter of the cross section is gradually reduced from bottom to top until the cross section is zero, the mechanical strength of the needle tip part which is closer to the bottom is higher, the probability of bending and breaking is reduced, the tangential inclination angle of the outer surface is gradually reduced from bottom to top, and the whole process of penetrating the skin by the needle tip part is easier.

Description

High-strength soluble microneedle
Citation of related application
The present application is a divisional application of the patent application of the invention with the application number 201810750048.2, the application date of the patent application of the invention is 2018, 7 and 10, and the name of the patent application is a high-strength soluble microneedle.
Technical Field
The invention belongs to the field of medical treatment and cosmetology, and particularly relates to a high-strength soluble microneedle.
Background
The painless transdermal drug delivery of the microneedle is used as a novel drug delivery technology, can create a micron-sized drug delivery channel on the skin painlessly, enhances the permeability of the skin to active substances or drugs, especially macromolecular drugs, and represents the development direction of the transdermal conduction of the drugs into the body in the future due to the advantages of painless, safety, easy operation and the like.
The manufacturing process of the soluble microneedle at the present stage is mainly divided into two main types, namely a mould shaping mode and a stretching shaping mode. For the mold mode, the viscous polymer material needs to be poured into a micro-level microneedle mold by using an external force mode of centrifugation and vacuumizing, so that the microneedle mold needs to be designed to have a bottom diameter larger than that of a needle point part, and the viscous solution is easy to completely fill in the mold; in the stretch-forming method, the microneedle structure is always formed by contacting with the viscous polymer droplets, and the manufacturing process utilizes the stretching and expanding characteristics of the viscous fluid, so that the shape of the manufactured microneedle cannot be freely controlled, and the microneedle structure is difficult to penetrate into the skin due to the limitation of the manufacturing process.
Disclosure of Invention
In order to overcome the defects in the prior art, the invention provides a high-strength soluble microneedle which combines fluid mechanics, is beneficial to penetrating the skin and is not easy to bend and break.
The technical scheme adopted for solving the technical problems is as follows:
the utility model provides a high strength soluble microneedle, includes substrate and a plurality of needle bodies of distributing on the substrate, the needle body includes the tip, the surface of tip is smooth curved surface, the cross section of tip is circular and the diameter from bottom to top diminishes gradually until being zero, the tangential inclination of the surface of tip diminishes gradually from bottom to top.
As an improvement of the above-mentioned technical means, the tip portion of the needle tip portion has a tip point, and an outer peripheral line of a longitudinal section of the needle tip portion passing through any of the tip points is continuously non-conductive at the tip point.
As an improvement of the technical scheme, the top outer surface of the needle tip part is continuously conductive everywhere.
As an improvement of the technical scheme, the needle body further comprises a needle bottom arranged at the lower end of the needle point, and the area of any cross section of the needle bottom is not smaller than the area of the bottom surface of the needle point.
As an improvement of the technical scheme, the needle tip and the needle bottom are respectively made of different soluble polymer materials, wherein the dissolution speed of the needle bottom in the skin is faster than that of the needle tip in the skin.
As an improvement of the above technical solution, the needle bottom comprises a cylinder, and the top surface of the cylinder coincides with the bottom surface of the needle tip.
As the improvement of the technical scheme, the needle bottom further comprises a truncated cone body, the truncated cone body is arranged at the lower end of the cylinder, the top surface of the truncated cone body is overlapped with the bottom surface of the cylinder, and the bottom of the truncated cone body is arranged on the substrate.
As an improvement of the technical scheme, the bottom of the needle is a truncated cone, the top surface of the truncated cone coincides with the bottom surface of the needle tip, and the bottom of the truncated cone is arranged on the substrate.
As an improvement of the technical scheme, the slope angle of the truncated cone is consistent with the inclination angle of the tangent line at the bottom end of the outer surface of the needle tip.
As an improvement of the technical scheme, the height range of the needle body is 50-5000 mu m, the diameter range of the bottom surface is 50-500 mu m, and the ratio of the diameter of the bottom surface to the height is 0.1-1.
The invention has the beneficial effects that:
the needle body structure of the microneedle combines with the hydrodynamic principle, the resistance when penetrating into the skin is reduced, the outer surface of the needle tip is a smooth curved surface, the cross section is circular, the diameter of the cross section is gradually reduced from bottom to top until the cross section is zero, the mechanical strength of the needle tip part which is closer to the bottom is higher, the probability of bending and breaking is reduced, the tangential inclination angle of the outer surface is gradually reduced from bottom to top, and the whole process of penetrating the skin by the needle tip part is easier.
Drawings
FIG. 1 is a schematic view of a first embodiment of the present invention;
FIG. 2 is a schematic diagram of a second embodiment of the present invention;
FIG. 3 is a schematic view of a third embodiment of the present invention;
FIG. 4 is a schematic diagram of a fourth embodiment of the present invention;
fig. 5 is a schematic structural diagram of a fifth embodiment of the present invention.
Detailed Description
Referring to fig. 1 to 5, the high-strength soluble microneedle of the present invention comprises a substrate 1 and a plurality of needle bodies 2 distributed on the substrate 1, wherein the substrate 1 can be adhered to the skin, the needle bodies 2 are internally loaded with functional cosmetics or pharmaceutical active ingredients, specifically, the height of the needle bodies 2 is 50-5000 μm, the diameter of the bottom surface is 50-500 μm, and the ratio of the diameter of the bottom surface to the height is 0.1-1.
The needle body 2 comprises a needle tip 21, the outer surface of the needle tip 21 is a smooth curved surface, the resistance of the needle tip 21 when penetrating into the skin is reduced by combining the fluid mechanics principle, the cross section of the needle tip 21 is circular, the diameter of the needle tip is gradually reduced from bottom to top until the diameter of the needle tip is zero, the mechanical strength of the needle tip 21 which is closer to the bottom is higher, the probability of bending fracture is reduced, and the tangential inclination angle of the outer surface of the needle tip 21 is gradually reduced from bottom to top, so that the whole process of penetrating into the skin by the needle tip 21 is easier.
As for the specific form of the needle tip 21, the present invention has two embodiments as follows:
example 1
The bottom of the needle tip 21 is arranged on the substrate 1, the top of the needle tip 21 is provided with a tip point 211, and any peripheral line passing through the longitudinal section of the needle tip of the tip point 211 is continuously non-conductive at the tip point 211, namely, the tangent line at one side of the tip point 211 is not coincident with the tangent line at the other side, so that the sharpness of the top of the needle tip 21 is ensured, and the needle is very beneficial to penetrating the skin while maintaining certain mechanical strength.
Example two
The bottom of tip portion 21 is located on substrate 1, tip portion 21's top surface everywhere is continuous can lead, guarantees that tip portion 21's top has slick and sly nature, when guaranteeing to pierce into skin conveniently, increases tip portion 21's mechanical strength, prevents effectively that the top of tip portion 21 from appearing the condition of bending fracture.
In addition, in other embodiments, the needle body 2 adopts a combination form, and comprises a needle tip 21 and a needle bottom 22 arranged at the lower end of the needle tip 21, the area of any cross section of the needle bottom 22 is not smaller than the area of the bottom surface of the needle tip 21, the needle tip 21 and the needle bottom 22 are respectively made of different soluble polymer materials, wherein the dissolution speed of the needle bottom 22 in the skin is faster than that of the needle tip in the skin, the functional cosmetics or the pharmaceutical active ingredients are only carried on the needle tip 21, the needle bottom 22 does not contain medicine, the instant effect is achieved, and on one hand, the slow release can be realized, and the pharmaceutical availability is increased; on the other hand, the dosage of the drug can be precisely controlled. The needle bottom 22 may be provided with a functional cosmetic or pharmaceutical active ingredient, and by adjusting the concentration of the ingredients or polymers of the needle tip 21 and the needle bottom 22, for example, the material constituting the needle bottom 22 is a material which is easily dissolved in water, such as PVP. After the needle body 2 is penetrated into the skin for a period of time, the needle bottom 22 can be quickly dissolved and broken, the needle tip 21 is retained in the skin, the slow release effect is exerted, and meanwhile, the substrate 1 is not required to be stuck on the skin for a long time, so that discomfort is prevented. The material of the needle tip 21 may be one or more of chondroitin sulfate, polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, methyl vinyl ether-maleic anhydride copolymer; the material of the needle bottom 22 may specifically be one or a mixture of more of polyvinylpyrrolidone, polyethylene glycol, polyvinyl alcohol, carboxymethyl cellulose, carbomer, trehalose, maltose, sucrose, raffinose, hyaluronic acid, sodium alginate, pullulan, dextran.
In addition, the needle tip 21 and the needle bottom 22 may be made of the same soluble polymer material, but the concentration is different, the concentration of the effective polymer constituting the needle tip 21 is far greater than that of the effective polymer constituting the needle bottom 22, for example, the effective component of the needle tip 21 is hyaluronic acid with a concentration of 70%, and the effective component of the needle bottom 22 is hyaluronic acid with a concentration of 30%, so that the needle bottom 22 is dissolved in the skin relatively quickly after penetrating into the skin to complete the rapid separation, the substrate 1 is also allowed to be separated easily, the substrate 1 can be removed quickly without waiting until the needle tip 21 is dissolved in the skin, discomfort is prevented, the needle tip 21 can be retained in the skin for a long time, a slow release effect is exerted, and the needle bottom 22 may be enriched with a skin stabilizing component or a rapid healing component so as to heal a skin wound rapidly after penetrating into the skin.
The needle bottom 22 may also be made of an insoluble material such as Polystyren polymer, ceramic, glass, metal, etc., which will allow the needle tip 21 to be effectively introduced into the skin quickly and the substrate and needle bottom 22 to be withdrawn without waiting or coating the substrate 1 for a longer period of time.
Specifically, the needle tip 21 may take the form of the first and second embodiments, and as for the specific form of the needle bottom 22, the present invention also has three embodiments, as follows:
example III
The needle bottom 22 is a cylinder 3, the top surface of the cylinder 3 coincides with the bottom surface of the needle tip 21, the bottom of the cylinder 3 is arranged on the substrate 1, the needle tip 21 adopts the same form as that of the second embodiment, after the needle tip 21 pierces the skin, the cylinder 3 can also easily pierce the skin, the resistance is very small, the mechanical strength of the whole needle body is effectively increased, and the deep layer of the skin can be pierced.
Example IV
The needle bottom 22 includes cylinder 3 and round platform body 4, round platform body 4 sets up in cylinder 3 lower extreme, the top surface of cylinder 3 coincides with the bottom surface of tip 21, the top surface of round platform body 4 coincides with the bottom surface of cylinder 3, the bottom of round platform body 4 is located on substrate 1, tip 21 adopts the same form of embodiment two, after tip 21 pierces skin, cylinder 3 and round platform body 4 also can pierce skin very easily, the resistance is very little, cylinder 3 can support tip 21 effectively, round platform body 4 can support cylinder 3 again effectively, whole needle body 2 can be more deep into the deep layer of skin, through adjusting round platform body 4 width and the high of tip 21 and cylinder 4, can adjust the depth that the microneedle structure pierces into skin effectively.
Example five
The needle bottom 22 is the round platform body 4, the top surface of round platform body 4 coincides with the bottom surface of tip 21, the bottom of round platform body 4 is located on the substrate 1, and tip 21 adopts the same form of embodiment one, the slope angle of round platform body 4 is unanimous with the tangential inclination of the surface bottom of tip 21, and after tip 21 pierces skin, round platform body 4 also can continue to pierce skin smoothly, and round platform body 4 can support tip 21 effectively, and the mechanical strength of whole needle body 2 is very high, and difficult rupture is crooked, can pierce the deep of skin moreover.
The present invention is not limited to the above embodiments, but is intended to be within the scope of the present invention as long as the technical effects of the present invention can be achieved by any same or similar means.

Claims (10)

1. A high strength soluble microneedle, characterized by: the needle comprises a substrate and a plurality of needle bodies distributed on the substrate, wherein the needle bodies comprise needle tips, the outer surfaces of the needle tips are smooth curved surfaces, the cross sections of the needle tips are round, the diameters of the needle tips gradually decrease from bottom to top until the diameters of the needle tips become zero, and the inclination angles of the tangential lines of the outer surfaces of the needle tips gradually decrease from bottom to top;
the needle body also comprises a needle bottom arranged at the lower end of the needle point, and the area of any cross section of the needle bottom is not smaller than the area of the bottom surface of the needle point.
2. A high strength soluble microneedle according to claim 1, wherein: the tip of the needle tip has a tip point at which the peripheral line of any longitudinal section of the needle tip passing through the tip point is continuously non-conductive.
3. A high strength soluble microneedle according to claim 1, wherein: the tip portion is continuously conductive at the top outer surface thereof.
4. A high strength soluble microneedle according to claim 1, wherein: the needle tip and the needle bottom are respectively made of different soluble high polymer materials, wherein the dissolution speed of the needle bottom in the skin is faster than that of the needle tip in the skin;
alternatively, the tip and the base are made of the same soluble polymer material, and the concentration of the effective polymer constituting the tip is much greater than the concentration of the effective polymer at the base.
5. A high strength soluble microneedle according to claim 1, wherein: the functional cosmetic or pharmaceutical active ingredient is only carried on the needle tip, and the needle bottom does not contain medicine;
or the needle bottom is rich in skin calming pharmaceutical ingredients or rapid healing ingredients.
6. A high strength soluble microneedle according to claim 1, wherein: the needle bottom comprises a cylinder, and the top surface of the cylinder coincides with the bottom surface of the needle tip.
7. A high strength soluble microneedle according to claim 6, wherein: the needle bottom also comprises a round table body, the round table body is arranged at the lower end of the cylinder, the top surface of the round table body is overlapped with the bottom surface of the cylinder, and the bottom of the round table body is arranged on the substrate.
8. A high strength soluble microneedle according to claim 1, wherein: the bottom of the needle is a truncated cone, the top surface of the truncated cone coincides with the bottom surface of the needle tip, and the bottom of the truncated cone is arranged on the substrate.
9. A high strength soluble microneedle according to claim 8, wherein: the slope angle of the truncated cone is consistent with the inclination angle of a tangent line at the bottom end of the outer surface of the needle tip.
10. A high strength soluble microneedle according to claim 1, wherein: the height of the needle body ranges from 50 to 5000 mu m, the diameter of the bottom surface ranges from 50 to 500 mu m, and the ratio of the diameter of the bottom surface to the height ranges from 0.1 to 1.
CN202311867843.7A 2018-07-10 2018-07-10 High-strength soluble microneedle Pending CN117797393A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202311867843.7A CN117797393A (en) 2018-07-10 2018-07-10 High-strength soluble microneedle

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201810750048.2A CN108939282B (en) 2018-07-10 2018-07-10 High-strength soluble microneedle
CN202311867843.7A CN117797393A (en) 2018-07-10 2018-07-10 High-strength soluble microneedle

Related Parent Applications (1)

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Publication Number Publication Date
CN117797393A true CN117797393A (en) 2024-04-02

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CN201810750048.2A Active CN108939282B (en) 2018-07-10 2018-07-10 High-strength soluble microneedle

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Families Citing this family (4)

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Publication number Priority date Publication date Assignee Title
WO2020200194A1 (en) * 2019-04-02 2020-10-08 宝龄富锦生技股份有限公司 Microneedle device and method for manufacturing same
CN111939452A (en) * 2019-05-15 2020-11-17 微邦科技股份有限公司 Microneedle structure and biodegradable microneedle thereof
TWI687247B (en) 2019-05-15 2020-03-11 微邦科技股份有限公司 Microneedle structure and biodegradable microneedle thereof
WO2022140984A1 (en) * 2020-12-28 2022-07-07 深圳由莱智能电子有限公司 Cosmetic handle

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CN204890943U (en) * 2015-08-07 2015-12-23 北京化工大学 Multistage needle array that declines
CN108024956A (en) * 2015-09-08 2018-05-11 富士胶片株式会社 Microneedle array
CN107456649A (en) * 2016-06-03 2017-12-12 赛诺凡生物科技有限公司 The microneedle patch containing hyaluronic acid for beautifying use
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