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CN103111019B - Straight inserting type self-pressing medication injecting hollow microneedle device - Google Patents

Straight inserting type self-pressing medication injecting hollow microneedle device Download PDF

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Publication number
CN103111019B
CN103111019B CN201310068469.4A CN201310068469A CN103111019B CN 103111019 B CN103111019 B CN 103111019B CN 201310068469 A CN201310068469 A CN 201310068469A CN 103111019 B CN103111019 B CN 103111019B
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air
end cap
check valve
hollow microneedle
deformable end
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Expired - Fee Related
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CN103111019A (en
Inventor
张亚军
蔡恒志
周刚
周万长
庄俭
薛领
王新良
王朝华
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NINGBO LIJIN MACHINERY CO Ltd
Beijing University of Chemical Technology
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NINGBO LIJIN MACHINERY CO Ltd
Beijing University of Chemical Technology
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0023Drug applicators using microneedles

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

Abstract

本发明提供一种直插式自压迫药物注射空心微针装置,包括空心针体和基板腔,端盖,手柄,弹性空气存储膜,止逆阀,泄气孔,输液孔等几个部分。所述的空心针体在基板腔结构上,端盖在手柄上,端盖与基板腔相连,端盖与基板腔之间为弹性空气存储膜,并且端盖上带有空气止逆阀与空气泄气孔。本发明利用施药时对手柄对端盖施加的力,使可变形的端盖和空气止逆阀实现了对弹性空气存储膜和端盖之间形成的空间气压的增加,端盖变形恢复时通过空气止逆阀的作用使这个空间的空气增加,气压恢复,并利用弹性空气存储膜把药物和空气分离,避免了空气对药物的污染。并且空气止逆阀及时恢复了弹性空气存储膜和端盖之间形成空间的气压,避免了药物的回流。

The invention provides a hollow microneedle device for in-line self-compressing drug injection, which includes a hollow needle body and a substrate cavity, an end cover, a handle, an elastic air storage membrane, a check valve, a vent hole, an infusion hole and the like. The hollow needle body is on the structure of the substrate cavity, the end cap is on the handle, the end cap is connected with the substrate cavity, an elastic air storage film is formed between the end cap and the substrate cavity, and the end cap is equipped with an air check valve and air Vent. The present invention utilizes the force exerted on the handle to the end cap when applying medicine, so that the deformable end cap and the air check valve realize the increase of the air pressure in the space formed between the elastic air storage film and the end cap, and when the deformation of the end cap recovers Through the action of the air check valve, the air in this space is increased, the air pressure is restored, and the elastic air storage membrane is used to separate the medicine from the air, avoiding the pollution of the air to the medicine. And the air check valve restores the air pressure in the space formed between the elastic air storage film and the end cap in time, avoiding the backflow of the medicine.

Description

直插式自压迫药物注射空心微针装置In-line self-compression hollow microneedle device for drug injection

技术领域technical field

本发明涉及药物控释与皮肤微创装置,特别涉及直插式自压迫药物注射空心微针装置。The invention relates to a drug controlled release and skin minimally invasive device, in particular to an in-line self-pressing drug injection hollow microneedle device.

背景技术Background technique

传统的经皮给药是药物通过表皮通道被动扩散进入真皮,再经毛细血管进入体循环。角质层的阻碍导致大多数药物分子无法通过以及给药最太少,而过于缓慢的释放速度很难达到治疗的目的,为此人们采取了各种措施来破坏角质层以增强皮肤对药物的渗透。由10-2000μm的微针组成的微针阵列是一种相对较新的给药途径,它不仅能够刺穿上层表皮创造出允许药物大分子甚至微粒通过的微米尺寸通道,又不致刺激神经产生疼痛引起临床意义的损伤。Traditional transdermal drug delivery involves passive diffusion of drugs into the dermis through epidermal channels, and then enters the systemic circulation through capillaries. The hindrance of the stratum corneum leads to the inability of most drug molecules to pass through and the least amount of drug administration, and the slow release rate is difficult to achieve the purpose of treatment. Therefore, various measures have been taken to destroy the stratum corneum to enhance skin penetration of drugs . The microneedle array composed of 10-2000μm microneedles is a relatively new drug delivery route, which can not only pierce the upper epidermis to create micron-sized channels that allow drug macromolecules and even particles to pass through, but will not stimulate nerves to cause pain cause clinically significant damage.

皮肤由外至内分为三层:角质层、表皮层及真皮层。角质层厚约10-20μm,是一层死组织,没有血管和神经,但却是药物经皮吸收的控释层;表皮层位于外皮下约50-100μm处,含有少量活细胞及神经,不含血管;更深处的真皮中含有大量的活细胞、神经及血管。微针是由微细加工技术制成的不同形状、结构及材料的微米级的针,通过在皮肤角质层产生微小孔道来提高药物的渗透性,这是介于皮下注射和透皮贴剂之间的一种给药方式。The skin is divided into three layers from outside to inside: stratum corneum, epidermis and dermis. The stratum corneum is about 10-20 μm thick, which is a layer of dead tissue without blood vessels and nerves, but it is a controlled release layer for drug percutaneous absorption; Contains blood vessels; the deeper dermis contains a large number of living cells, nerves and blood vessels. Microneedles are micron-sized needles of different shapes, structures and materials made by microfabrication technology, which can improve the permeability of drugs by creating tiny pores in the stratum corneum of the skin, which is between subcutaneous injection and transdermal patch. a method of administration.

一般传统的方法,活性养分只能渗透入表皮的阻隔层(即角质层),效果并不显著(只达到约百分之零点三的成效)。利用微针微小的针头刺激皮肤,令活性成分有效渗入皮肤,同时微针刺激真皮层,通过皮肤的自愈能力,促进骨胶原增生,可使皮肤表皮层的厚度增生约百分之八,其效果可媲美激光及填充式的整形手术。而微针技术的副作用极低,安全可靠。In general traditional methods, active nutrients can only penetrate into the barrier layer of the epidermis (ie, the stratum corneum), and the effect is not significant (only about 0.3% of the effect is achieved). Stimulate the skin with the tiny needles of microneedles, so that the active ingredients can effectively penetrate into the skin. At the same time, the microneedles stimulate the dermis, promote the proliferation of collagen through the self-healing ability of the skin, and increase the thickness of the epidermis by about 8%. The effect is comparable to laser and filling plastic surgery. The microneedle technology has extremely low side effects and is safe and reliable.

发明内容Contents of the invention

本发明的目的是提供一种直插式自压迫药物注射空心微针装置,由于传统的注射方式会使人产生疼痛的感觉,并且不适合人体局部施药。本发明提供了一种无痛的空心微针给药方式,便于对病人进行精确的施药。The object of the present invention is to provide a hollow microneedle device for in-line self-pressing drug injection, because the traditional injection method will cause pain and is not suitable for local drug administration to the human body. The invention provides a painless hollow microneedle drug delivery method, which is convenient for precise drug delivery to patients.

空心针体和基板腔,端盖,手柄,弹性空气存储膜,空气止逆阀,泄气孔,输液孔等。Hollow needle body and base plate cavity, end cap, handle, elastic air storage membrane, air check valve, vent hole, infusion hole, etc.

空心针体在基板腔上,端盖连接在手柄上,端盖与基板腔相连,端盖与基板腔之间为弹性空气存储膜,并且端盖上带有空气止逆阀与空气泄气孔。The hollow needle body is on the base plate cavity, the end cover is connected to the handle, the end cover is connected with the base plate cavity, an elastic air storage film is formed between the end cover and the base plate cavity, and an air check valve and an air release hole are provided on the end cover.

施药时对手柄对端盖施加的力,使可变形的端盖和空气止逆阀实现了对弹性空气存储膜和端盖之间形成的空间气压的增加,从而推动基板腔内的药物的注射,端盖变形恢复时通过空气止逆阀的作用使这个空间的空气增加,气压恢复,并且由于空气止逆阀3的作用,上面的过程可重复操作。The force exerted by the handle on the end cap during drug application enables the deformable end cap and air check valve to increase the air pressure in the space formed between the elastic air storage film and the end cap, thereby pushing the drug in the substrate cavity. Injection, when the deformation of the end cap recovers, the air in this space is increased through the action of the air check valve, and the air pressure is restored, and due to the action of the air check valve 3, the above process can be repeated.

弹性空气存储膜把空气和药物分离,避免了空气对药物的污染。The elastic air storage membrane separates the air from the medicine, avoiding the pollution of the medicine by the air.

空气止逆阀的存在,及时恢复了弹性空气存储膜和端盖之间形成空间的气压,避免了药物的回流。The existence of the air check valve restores the air pressure in the space formed between the elastic air storage membrane and the end cap in time, avoiding the backflow of the drug.

基板腔和端盖上开有防止弹性空气存储膜滑动和漏气的槽,弹性空气存储膜边缘有凸起,凸起和基板腔和端盖上的槽配合。The substrate cavity and the end cover are provided with grooves to prevent the elastic air storage film from sliding and leaking, and the elastic air storage film has protrusions on the edge, which cooperate with the grooves on the substrate cavity and the end cover.

空气止逆阀为贴片形式,存在于端盖内部,或者为其他形式的止逆阀。The air check valve is in the form of a patch, which exists inside the end cap, or is another form of check valve.

端盖为弹性材料。The end caps are elastic material.

空心微针的高度为0.2mm~3mm,针的外部直径为0.05mm~1mm,内部直径为0.02mm~0.8mm。The height of the hollow microneedle is 0.2mm-3mm, the outer diameter of the needle is 0.05mm-1mm, and the inner diameter is 0.02mm-0.8mm.

空心微针的材料为医用不锈钢,生物相容材料,可降解型材料或PMMA等聚合物。The hollow microneedles are made of medical stainless steel, biocompatible materials, degradable materials or polymers such as PMMA.

本发明与背景技术相比,具有的有益的效果是:Compared with the background technology, the present invention has the beneficial effects that:

本发明利用施药时对手柄施加的力,使可变形的端盖和空气止逆阀实现了对弹性空气存储膜中空气的增加,从而推动基板腔内的药物的注射。本发明把药物和空气分离,避免了空气对药物的污染。并且由于空气止逆阀的存在,避免了药物的回流。The invention utilizes the force exerted on the handle during drug application, so that the deformable end cap and the air check valve realize the increase of air in the elastic air storage film, thereby promoting the injection of the drug in the cavity of the substrate. The invention separates the medicine from the air, avoiding the pollution of the medicine by the air. And due to the existence of the air check valve, the backflow of the medicine is avoided.

附图说明Description of drawings

图1是本发明整体的结构示意图。Fig. 1 is a schematic diagram of the overall structure of the present invention.

图2是基板腔背面示意图。Fig. 2 is a schematic diagram of the back side of the substrate chamber.

图3是基板腔正面示意图。Fig. 3 is a schematic front view of the substrate cavity.

图4是弹性空气存储膜示意图。Figure 4 is a schematic diagram of an elastic air storage membrane.

图5是端盖连接示意图。Figure 5 is a schematic diagram of the connection of the end cap.

图6是手柄示意图。Figure 6 is a schematic diagram of the handle.

具体实施方式Detailed ways

以下结合附图进一步说明,参见图2、图3、图4、图5、图6所示,空心针体在基板腔上,端盖连接在手柄上,端盖与基板腔相连,端盖与基板腔之间为弹性空气存储膜,并且端盖上带有空气止逆阀与空气泄气孔。The following will be further described in conjunction with the accompanying drawings, as shown in Figure 2, Figure 3, Figure 4, Figure 5, and Figure 6. The hollow needle body is on the substrate cavity, the end cover is connected to the handle, the end cover is connected to the substrate cavity, and the end cover is connected to the substrate cavity. There is an elastic air storage film between the substrate cavities, and an air check valve and an air release hole are provided on the end cover.

手柄对端盖施加的力,使可变形的端盖和空气止逆阀实现了对弹性空气存储膜和端盖之间形成的空间气压的增加,从而推动基板腔内的药物的注射,端盖变形恢复时通过空气止逆阀的作用使这个空间的空气增加,气压恢复,当进行给药时,空气泄气孔关闭,当对微针进行灌药时,此空气泄气孔打开。The force exerted by the handle on the end cap enables the deformable end cap and the air check valve to increase the air pressure in the space formed between the elastic air storage membrane and the end cap, thereby pushing the injection of the drug in the substrate cavity, and the end cap When the deformation recovers, the air in this space is increased by the action of the air check valve, and the air pressure is restored. When the drug is administered, the air vent hole is closed, and when the microneedle is filled with medicine, the air vent hole is opened.

基板腔和端盖上开有防止弹性空气存储膜滑动和漏气的槽,弹性空气存储膜边缘有凸起,凸起和基板腔和端盖上的槽配合。The substrate cavity and the end cover are provided with grooves to prevent the elastic air storage film from sliding and leaking, and the elastic air storage film has protrusions on the edge, which cooperate with the grooves on the substrate cavity and the end cover.

Claims (8)

1.直插式自压迫药物注射空心微针装置,其特征在于它包括:空心针体(1)和基板腔(2),可变形端盖(5),手柄(6),弹性空气存储膜(8),空气止逆阀(3),泄气孔(7),输液孔(4);其连接关系为:空心针体(1)在基板腔(2)上,可变形端盖(5)连接在手柄(6)上,可变形端盖(5)与基板腔(2)相连,可变形端盖(5)与基板腔(2)之间为弹性空气存储膜(8),并且可变形端盖上带有空气止逆阀(3)与空气泄气孔(7);施药时通过手柄(6)对可变形端盖(5)施加的力,使可变形的端盖(5)和空气止逆阀(3)实现了对弹性空气存储膜(8)和可变形端盖(5)之间形成的空间气压的增加,从而推动基板腔(2)内的药物的注射,可变形端盖(5)变形恢复时通过空气止逆阀(3)的作用使这个空间的空气增加,气压恢复,并且由于空气止逆阀(3)的作用,上面的过程可重复操作。1. In-line self-compressing hollow microneedle device for drug injection, characterized in that it includes: a hollow needle body (1) and a substrate cavity (2), a deformable end cap (5), a handle (6), and an elastic air storage membrane (8), air check valve (3), vent hole (7), infusion hole (4); the connection relationship is: the hollow needle body (1) is on the substrate cavity (2), and the deformable end cap (5) Connected to the handle (6), the deformable end cap (5) is connected to the substrate cavity (2), and the elastic air storage film (8) is between the deformable end cap (5) and the substrate cavity (2), and is deformable There is an air check valve (3) and an air vent hole (7) on the end cover; the force exerted on the deformable end cover (5) by the handle (6) makes the deformable end cover (5) and the The air check valve (3) increases the air pressure in the space formed between the elastic air storage membrane (8) and the deformable end cap (5), thereby promoting the injection of the drug in the substrate cavity (2), and the deformable end cap When the deformation of the cover (5) recovers, the air in this space is increased by the action of the air check valve (3), and the air pressure is restored, and due to the action of the air check valve (3), the above process can be repeated. 2.根据权利要求1所述的直插式自压迫药物注射空心微针装置,其特征在于:弹性空气存储膜(8)把空气和药物分离,避免了空气对药物的污染。2. The in-line self-pressing hollow microneedle device for drug injection according to claim 1, characterized in that: the elastic air storage membrane (8) separates the air from the drug, avoiding air pollution to the drug. 3.根据权利要求1所述的直插式自压迫药物注射空心微针装置,其特征在于:空气止逆阀(3)的存在,及时恢复了弹性空气存储膜(8)和可变形端盖(5)之间形成空间的气压,避免了药物的回流。3. The in-line self-compression hollow microneedle device for drug injection according to claim 1, characterized in that: the presence of the air check valve (3) restores the elastic air storage membrane (8) and the deformable end cap in time (5) The air pressure that forms the space between has avoided the reflux of medicine. 4.根据权利要求1所述的直插式自压迫药物注射空心微针装置,其特征在于:基板腔(2)和可变形端盖(5)上开有防止弹性空气存储膜滑动和漏气的槽,弹性空气存储膜(8)边缘有凸起,凸起和基板腔(2)和可变形端盖(5)上的槽配合。4. The in-line self-compressing hollow microneedle device for drug injection according to claim 1, characterized in that: the substrate cavity (2) and the deformable end cap (5) are provided with anti-elastic air storage membranes to prevent sliding and air leakage There are grooves on the edge of the elastic air storage film (8), and the projections cooperate with the grooves on the substrate cavity (2) and the deformable end cover (5). 5.根据权利要求1所述的直插式自压迫药物注射空心微针装置,其特征在于:空气止逆阀(3)为贴片形式,存在于可变形端盖(5)内部。5. The in-line self-compression hollow microneedle device for drug injection according to claim 1, characterized in that the air check valve (3) is in the form of a patch and exists inside the deformable end cap (5). 6.根据权利要求1所述的直插式自压迫药物注射空心微针装置,其特征在于:可变形端盖(5)为弹性材料。6. The in-line self-pressing hollow microneedle device for drug injection according to claim 1, characterized in that the deformable end cap (5) is made of elastic material. 7.根据权利要求1所述的直插式自压迫药物注射空心微针装置,其特征在于:空心微针的高度为0.2mm~3mm,针的外部直径为0.05mm~1mm,内部直径为0.02mm~0.8mm。7. The in-line self-compression hollow microneedle device for drug injection according to claim 1, characterized in that: the height of the hollow microneedle is 0.2 mm to 3 mm, the outer diameter of the needle is 0.05 mm to 1 mm, and the inner diameter is 0.02 mm. mm ~ 0.8mm. 8.根据权利要求1所述的直插式自压迫药物注射空心微针装置,其特征在于:空心微针的材料为医用不锈钢、生物相容材料或可降解材料、PMMA聚甲基丙烯酸甲酯。8. The in-line self-compressing hollow microneedle device for drug injection according to claim 1, characterized in that: the material of the hollow microneedle is medical stainless steel, biocompatible material or degradable material, PMMA polymethyl methacrylate .
CN201310068469.4A 2013-03-04 2013-03-04 Straight inserting type self-pressing medication injecting hollow microneedle device Expired - Fee Related CN103111019B (en)

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CN103111019B true CN103111019B (en) 2014-08-20

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