CN102018595A - Targeting inner ear droplet drug dispenser and use method thereof - Google Patents

Targeting inner ear droplet drug dispenser and use method thereof Download PDF

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Publication number
CN102018595A
CN102018595A CN 201010602665 CN201010602665A CN102018595A CN 102018595 A CN102018595 A CN 102018595A CN 201010602665 CN201010602665 CN 201010602665 CN 201010602665 A CN201010602665 A CN 201010602665A CN 102018595 A CN102018595 A CN 102018595A
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inner ear
drug
droplet
polyimide tube
ear
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CN 201010602665
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Chinese (zh)
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逸马锐皮克
邹静
郑宏良
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中国人民解放军第二军医大学
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Abstract

The invention belongs to the technical field of medical appliances, in particular to a targeting inner ear droplet drug dispenser and a use method thereof. On the basis of the utilization of new material and imageology study, an ultrathin polyimide tube is connected with a micro upgrading injector to realize dispensing drug to the inner ear via the middle ear in the mode of super minimally invasive target. Single dispensing volume in rats is only 2 microlitres and is 10-20 microlitres in the human body. The live animal magnetic resonance imaging research proves that the drug can be dispensed to the inner ear by the product of the invention within half an hour and is evenly distributed on the cochlea after 3 hours, and a minimum quantity of drug is distributed in the non-curative areas, such as the middle ear and the like. Therefore, the targeting inner ear droplet drug dispenser can furthest reduce side effect caused by non-specific distribution of drug at the same time of achieving a treatment effect. The invention is superior to the market product and is an inner ear drug dispenser with the brand-new concept.

Description

一种靶向性内耳微滴药物投放器及其使用方法技术领域[0001] 本发明属于医疗器械技术领域,具体涉及一种内耳微滴药物投放器及其使用方法。 One targeting inner ear droplet dispenser pharmaceutical use thereof TECHNICAL FIELD [0001] The present invention belongs to the technical field of medical devices, particularly relates to inner ear droplet dispenser one kind of medicament and methods of use. 背景技术[0002] 经鼓室注射向内耳进行药物投放,被认为是迄今最微小创伤的内耳药物投放方式,通过限制药物在机体其他部位的分布而减少药物的副作用。 [0002] transtympanic injection into the inner ear for drug administration, drug administration is considered to be the inner ear by far the most minor trauma embodiment, by limiting the distribution of the drug in other parts of the body to reduce drug side effects. 然而,经中耳粘膜吸收、经咽鼓管引流而吞咽的药物剂量远高于其进入内耳的量。 However, absorption through the middle ear mucosa, drug dose through the eustachian tube drainage of swallowing an amount much higher than it enters the inner ear. 内耳的药代动力学要求持续性地进行药物投放,而经过鼓膜直接注射实际上不可行。 Inner ear pharmacokinetic requirements continuing to drug delivery, and direct injection through the tympanic membrane is actually feasible. 因此,一种特殊设计的经过圆窗向内耳进行药物投放的装置:美国的Silverstein MicroWick device面市了。 Therefore, a special design of a device through the round window of drug delivery to the inner ear: the United States Silverstein MicroWick device market up. 但是,该装置直径很粗,需要经过中耳通风管安装使用,创伤大,容易导致感染,且注射体积很大,无法避免上述非靶子部位的吸收造成的副作用。 However, the diameter of the device is very thick, need to go through the middle ear ventilation pipe installation, trauma, easily lead to infection, and a large volume injections, can not avoid the side effects of the non-target site of absorption. 发明内容[0003] 本发明的目的在于提供一种操作方便、创伤小,且可避免非靶子部位吸收造成副作用的靶向性内耳微滴药物投放器。 SUMMARY OF THE INVENTION [0003] The object of the present invention is to provide a convenient, less invasive, and non-target sites can be avoided absorbent targeted inner ear cause side effects droplet medicament dispenser. [0004] 本发明人经过长期的内耳磁共振成像研究,发现从中耳到内耳的药物转运存在卵圆窗和圆窗两条途径,且卵圆窗途径比圆窗途径更加有效。 [0004] The present invention after long-term magnetic resonance imaging studies of the inner ear, the oval window and round window discovered two ways exist from the middle ear to the inner ear of drug transporters, and more effective than the oval window, the round window route pathway. 组织学研究表明, 连接镫骨地板与卵圆窗的镫骨环韧带由多孔的原纤蛋白(36-kDa microfibril-associated glycoprotein, MAGP-36)和透明质酸组成,理论上比三层结构的圆窗更加容易通过各种药物。 Histological studies have shown, the floor and connected to the oval window stapes stapes ligament ring of porous fibrillin (36-kDa microfibril-associated glycoprotein, MAGP-36) and hyaluronic acid, theoretically than three-layer structure round window more easily through a variety of drugs. 在此基础上,本发明设计了一种内耳微滴药物投放器。 On this basis, the present invention contemplates a pharmaceutical inner ear droplet dispenser. 该药物投放器由超细聚酰亚胺管与微型注射器(如微升级注射装置)相连接组成,实现超级微创靶向性地经过中耳向内耳进行药物投放。 The medicament dispenser microfine polyimide tube with a micro-syringe (e.g., microliter injection device) is connected to the composition, to achieve super-invasive targeting drug delivery to the inner ear via the middle ear. 其结构如图1所示。 The structure shown in Figure 1. [0005] 本发明中,所述超细聚酰亚胺管的内径为100 ym—HOym,外径为160 μ m__200 μ m。 [0005] In the present invention, the inner diameter of the microfine polyimide tube is 100 ym-HOym, an outer diameter of 160 μ m__200 μ m. [0006] 本发明的靶向性内耳微滴药物投放器的使用方法为,用注射器针头在鼓膜上面进行微孔穿刺,孔径小于1毫米;然后将靶向性内耳微滴药物投放器的超细聚酰亚胺管经过该微孔植入于鼓室内侧壁;在需要持续药物投放时,用生物兼容性粘合剂将超细聚酰亚胺管固定于外耳道,用微升级注射装置定时注射药物。 [0006] The present invention is targeted inner ear of droplets used as a drug delivery device, micropore puncture with a syringe needle above the tympanic membrane, pore size of less than 1 mm; then targeted inner ear droplets ultrafine medicament dispenser after the microporous polyimide tube implanted in the inner sidewall of the drum; when sustained drug delivery is required, with a biocompatible adhesive microfine polyimide tube is fixed to the external auditory canal, with microliter injection timing of drug injection apparatus . [0007] 使用本内耳微滴药物投放器,单次投放体积在大鼠仅为2微升,在人类为10—20微升。 [0007] The use of the present ear droplet drug administration, a single serving only 2 [mu] l volume in the rat, human 10-20 microliters. [0008] 活体动物磁共振成像研究证实,本发明产品在半小时之内便可将药物投放至内耳,3小时后药物在耳蜗均勻分布,中耳等非治疗区域的药物分布极少,在实现治疗效果的同时,最大限度地减少因药物非特异分布而导致的副作用,减少感染并发症发生率。 [0008] The magnetic resonance imaging confirmed that live animals, products of the invention can be within half an hour of drug delivery into the inner ear, the drug evenly distributed in the cochlea after 3 hours, the drug and other non-therapeutic region ear distributed little in achieving while the therapeutic effect, minimizing the side effects due to non-specific distribution of drugs could reduce the incidence of complications of infection. 附图说明[0009] 图1为靶向性内耳微滴药物投放器结构图。 BRIEF DESCRIPTION [0009] FIG. 1 is a pharmaceutical targeted inner ear droplet dispenser structure. [0010] 图2为大鼠活体内耳磁共振成像显示经本发明产品投放钆在内耳的动态分布。 [0010] FIG. 2 is a magnetic resonance imaging in vivo rat ear display dynamic distribution of gadolinium in the inner ear served by the product of the invention. [0011] 图中标号:1为微型注射器,2为连接管,3为超细聚酰亚胺管。 [0011] FIG numerals: 1 is a micro-syringe, the connection pipe 2, 3 for the ultrafine polyimide tube. 具体实施方式[0012] 如图1所示,本发明的靶向性内耳微滴药物投放器,由微型注射器1和超细聚酰亚胺管3经中间连接管2连接组成。 DETAILED DESCRIPTION [0012] As shown in FIG. 1, the present invention is targeted inner ear droplet drug administration, a syringe 3 by a microcomputer 1 via the intermediate connector and microfine polyimide tube 2 connecting pipe. 其中,微型注射器1采用微升级注射装置,超细聚酰亚胺管3的内径为122 ym,外径为180 μ m,中间连接管2两端的口径分别与微型注射器1的注射口径和超细聚酰亚胺管3的管径匹配。 Wherein, a micro syringe using 1 microliter of the injection device, the inner diameter of microfine polyimide tube 3 is 122 ym, an outer diameter of 180 μ m, diameter of the intermediate connecting pipe ends 2 respectively and ultrafine micro-syringe injection aperture 1 polyimide tube 3 of diameter matching. [0013] 使用时,用注射器针头在鼓膜上面进行微小穿刺,孔径小于1毫米。 [0013] In use, the top minor puncture the tympanic membrane with a syringe needle, a pore size less than 1 mm. 然后将靶向性内耳微滴药物投放器的超细聚酰亚胺管3经过该孔植入于鼓室内侧壁。 Then the drug targeted inner ear droplet dispenser microfine polyimide tube 3 through the sidewall of the hole is implanted in the drum interior. 在需要持续药物投放时,用生物兼容性粘合剂将超细聚酰亚胺管3固定于外耳道,用微升级注射装置定时注射(大鼠每次为2微升,人类每次为10-20微升)。 Sustained drug delivery when needed, with a biocompatible adhesive microfine polyimide tube 3 is fixed to the external auditory canal, with microliter injection timing of the injection device (2 [mu] l per rat, human per 10- 20 microliters). 30分钟开始出现内耳药物分布,3小时在内耳分布均勻,见图2所示。 30 minutes began ear drug distribution, a uniform distribution of the inner ear for 3 hours, as shown in Figure 2.

Claims (4)

  1. 1. 一种靶向性内耳微滴药物投放器,其特征在于由超细聚酰亚胺管与微升级注射装置相连接组成。 A targeted inner ear droplet drug administration, characterized in that a microfine polyimide tube and is connected to the injection device microliter composition.
  2. 2.根据权利要求1所述的靶向性内耳微滴药物投放器,其特征在于所述超细聚酰亚胺管的内径为100 μιη—140μιη ,外径为160 μ m—200 μ m。 The targeting of the inner ear of a medicament droplet dispenser, characterized in that the inner diameter of the microfine polyimide tube is 100 μιη-140μιη, an outer diameter of 160 μ m-200 μ m as claimed in claim.
  3. 3. —种如权利要求1所述的靶向性内耳微滴药物投放器的使用方法,其特征在于用注射器针头在鼓膜上面进行微孔穿刺,孔径小于1毫米;然后将靶向性内耳微滴药物投放器的超细聚酰亚胺管经过该微孔植入于鼓室内侧壁;在需要持续药物投放时,用生物兼容性粘合剂将超细聚酰亚胺管固定于外耳道,用微升级注射装置定时注射药物。 3 - targeting species, such as the inner ear of claim 1 droplet dispenser pharmaceutical use, characterized in that the micropore puncture with a syringe needle above the tympanic membrane, pore size of less than 1 mm; then targeted inner ear microcirculation dropwise medicament dispenser microfine polyimide tube through the microporous implant to the drum interior sidewall; when sustained drug delivery is required, with a biocompatible adhesive microfine polyimide tube is fixed to the external auditory canal, with means microliter injection timing of injection of drugs.
  4. 4.根据权利要求3所述的使用方法,其特征在于注射药物的量,大鼠每次为2微升, 人类每次为10-20微升。 4. The method according to claim 3, characterized in that the amount of drug injection, each rat was 2 microliters, 10-20 microliters of each human.
CN 201010602665 2010-12-23 2010-12-23 Targeting inner ear droplet drug dispenser and use method thereof CN102018595A (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004077476A (en) * 2002-08-01 2004-03-11 Commissariat A L'energie Atomique Apparatus for injecting/mixing liquid droplets
CN101528283A (en) * 2005-01-24 2009-09-09 纽罗赛斯特克公司 Apparatus and method for delivering therapeutic and/or other agents to the inner ear and to other tissues
US20100016450A1 (en) * 2008-07-21 2010-01-21 Otonomy, Inc. Controlled release delivery devices for the treatment of otic disorders

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004077476A (en) * 2002-08-01 2004-03-11 Commissariat A L'energie Atomique Apparatus for injecting/mixing liquid droplets
CN101528283A (en) * 2005-01-24 2009-09-09 纽罗赛斯特克公司 Apparatus and method for delivering therapeutic and/or other agents to the inner ear and to other tissues
US20100016450A1 (en) * 2008-07-21 2010-01-21 Otonomy, Inc. Controlled release delivery devices for the treatment of otic disorders

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
《Journal of Biomedical Materials Research Part B:Applied Biomaterials》 20081031 Jing Zou,et al Distribution of Lipid Nanocapsules in Different Cochlear Cell Populations After Round Window Membrane Permeation 第10-18页 1-4 第87B卷, 第1期 *

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