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CN116035800A - A subcutaneous implantable repeat drug delivery device through the semicircular canal inner ear - Google Patents

A subcutaneous implantable repeat drug delivery device through the semicircular canal inner ear Download PDF

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CN116035800A
CN116035800A CN202310342881.4A CN202310342881A CN116035800A CN 116035800 A CN116035800 A CN 116035800A CN 202310342881 A CN202310342881 A CN 202310342881A CN 116035800 A CN116035800 A CN 116035800A
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杜政德
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Beijing Friendship Hospital
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F11/00Methods or devices for treatment of the ears or hearing sense; Non-electric hearing aids; Methods or devices for enabling ear patients to achieve auditory perception through physiological senses other than hearing sense; Protective devices for the ears, carried on the body or in the hand
    • A61F11/20Ear surgery
    • 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
    • A61M31/00Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/002Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time
    • 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
    • A61M2210/00Anatomical parts of the body
    • A61M2210/06Head
    • A61M2210/0662Ears

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Abstract

本发明涉及一种皮下植入式经半规管内耳重复给药装置,其包括:给药装置,用于精确推动微量给药器进行精确给药,其包括给药装置外壳和传动结构,所述传动结构设置在所述给药装置外壳内部;微量给药器,用于吸取治疗药物并将药物打出,将药物打入患者皮下的给药装置;给药装置;其包括给药底座和给药导管,所述给药底座埋至患者耳后,给药导管设置在患者乳突内部,给药导管的末端插入半规管,所述给药导管与给药底座固定连接,给药导管与给药底座内部相通;所述微量给药器与给药装置可拆卸连接,所述微量给药器可连接导管扎入给药底座内部向其打药,可治疗内耳疾病。

Figure 202310342881

The invention relates to a subcutaneously implanted repeat drug delivery device through the semicircular canal inner ear, which includes: a drug delivery device for precisely pushing a micro-dosing device for precise drug delivery, which includes a drug delivery device housing and a transmission structure, the transmission The structure is arranged inside the shell of the drug delivery device; the micro-dosing device is used to absorb the therapeutic drug and eject the drug, and inject the drug into the patient's subcutaneous drug delivery device; the drug delivery device; it includes a drug delivery base and a drug delivery catheter , the drug administration base is buried behind the patient's ear, the drug delivery catheter is arranged inside the patient's mastoid, the end of the drug delivery catheter is inserted into the semicircular canal, the drug delivery catheter is fixedly connected to the drug delivery base, and the drug delivery catheter is connected to the inside of the drug delivery base. Communication; the micro-dosing device is detachably connected to the drug delivery device, and the micro-dosing device can be connected to a catheter and inserted into the interior of the drug delivery base to inject medicine to it, which can treat inner ear diseases.

Figure 202310342881

Description

一种皮下植入式经半规管内耳重复给药装置A subcutaneous implantable repeat drug delivery device through the semicircular canal inner ear

技术领域technical field

本发明属于医疗器械技术领域,具体涉及为一种皮下植入式经半规管内耳重复给药装置。The invention belongs to the technical field of medical devices, and in particular relates to a subcutaneous implanted repeat drug delivery device through the semicircular canal inner ear.

背景技术Background technique

内耳又称迷路,包括半规管(外半规管、前半规管和后半规管)、前庭和耳蜗,迷路由一层膜性结构分为两部分,其外侧为骨质和膜性结构之间的间隙,称为骨迷路,其内充满外淋巴液,膜性结构内部为膜迷路,其内充满内淋巴液,内淋巴液的体积约34微升。内耳的感受器位于膜迷路,其周围的微环境为内淋巴液。内耳感受器包括位于半规管的壶腹,位于前庭的椭圆囊和球囊,位于耳蜗的毛细胞,内耳感受器主要感受直线和角加速度、重力和声音。内耳的病变和损伤可导致眩晕、耳鸣和耳聋,由于尚无有效内耳给药途径及给药装置,临床上多采用口服、静脉和中耳给药的方法予以治疗,由于药物的副作用,口服和静脉给药的剂量往往难以达到有效内耳药物浓度,具有基础疾病(高血压病、糖尿病和肾病等)的患者,口服和静脉给药更是受到很大限制。中耳给药虽然可实现局部给药目的,但由于中耳腔和鼻咽部通过咽鼓管沟通,药液常通过咽鼓管快速流出中耳腔,且中耳给药需要通过圆窗膜渗透,且渗透的药液只能到达内耳外淋巴液,但内耳感受器位于内淋巴液,因此药液还需跨过外淋巴液和内淋巴液之间的膜性结构这一屏障,难以达到内淋巴液中有效的药物浓度。目前虽然可以通过圆窗植入人工耳蜗电极,经电极侧孔实现内耳给药,但这种给药也是将药液释放进入外淋巴液,给药的目的主要是为了减轻电极植入引起的内耳炎症反应等。随着生物医药技术的发展,基因治疗、干细胞治疗和生物靶向治疗将更多地应用于内耳疾病,急需开发一种安全有效可重复的内耳给药装置。The inner ear, also known as the labyrinth, includes the semicircular canals (outer semicircular canal, anterior semicircular canal, and posterior semicircular canal), vestibule, and cochlea. The labyrinth is divided into two parts by a membranous structure, and the outer side is the gap between the bony and membranous structures, called The bony labyrinth is filled with perilymph, and the membranous labyrinth is inside the membranous structure, which is filled with endolymph. The volume of endolymph is about 34 microliters. The receptors of the inner ear are located in the membranous labyrinth, and the microenvironment around it is the endolymph. The inner ear receptors include the ampulla located in the semicircular canal, the utricle and sacculus located in the vestibule, and the hair cells located in the cochlea. The inner ear receptors mainly sense linear and angular acceleration, gravity and sound. Lesions and injuries of the inner ear can lead to dizziness, tinnitus and deafness. Since there is no effective drug delivery route and drug delivery device for the inner ear, oral, intravenous and middle ear drug methods are often used clinically for treatment. Due to the side effects of drugs, oral and The dose of intravenous administration is often difficult to reach the effective inner ear drug concentration, and patients with underlying diseases (hypertension, diabetes, kidney disease, etc.) are greatly restricted by oral and intravenous administration. Although middle ear administration can achieve the purpose of local administration, because the middle ear cavity and nasopharynx communicate through the Eustachian tube, the liquid often flows out of the middle ear cavity quickly through the Eustachian tube, and middle ear administration needs to pass through the round window membrane Infiltration, and the infiltrated medicinal liquid can only reach the outer lymph of the inner ear, but the receptors of the inner ear are located in the endolymph, so the medicinal liquid needs to cross the membrane structure barrier between the perilymph and endolymph, and it is difficult to reach the inner ear. Effective drug concentration in lymph fluid. Although the cochlear implant electrode can be implanted through the round window at present, and the inner ear drug delivery can be realized through the side hole of the electrode, but this kind of drug delivery also releases the drug solution into the perilymph. inflammatory response, etc. With the development of biomedical technology, gene therapy, stem cell therapy and biological targeted therapy will be more applied to inner ear diseases, and it is urgent to develop a safe, effective and repeatable inner ear drug delivery device.

本发明针对上述问题,提供一种皮下植入式经半规管内耳重复给药装置。Aiming at the above problems, the present invention provides a subcutaneously implanted repeat drug delivery device through the semicircular canal inner ear.

发明内容Contents of the invention

为了克服背景技术中提出的问题,本发明采用如下技术方案:In order to overcome the problems proposed in the background technology, the present invention adopts the following technical solutions:

一种皮下植入式经半规管内耳重复给药装置,其包括:A subcutaneous implantable repeat drug delivery device through the semicircular canal inner ear, which includes:

给药装置,用于精确推动微量给药器进行精确给药;其包括给药装置外壳和传动结构,所述传动结构设置在所述给药装置外壳内部;The drug delivery device is used to accurately push the micro-dosing device for precise drug delivery; it includes a drug delivery device housing and a transmission structure, and the transmission structure is arranged inside the drug delivery device housing;

微量给药器,用于吸取治疗药物并将药物打出,将药物打入患者皮下的给药装置;Micro-dosing device, which is used to absorb therapeutic drugs and eject the drugs, and inject the drugs into the patient's subcutaneous drug delivery device;

给药装置;其包括给药底座和给药导管,所述给药底座埋至患者耳后,给药导管设置在患者耳朵内部,给药导管的末端插入半规管,所述给药导管与给药底座固定连接,给药导管与给药底座内部相通;Drug delivery device; it includes a drug delivery base and a drug delivery catheter, the drug delivery base is buried behind the patient's ear, the drug delivery guide is arranged inside the patient's ear, and the end of the drug delivery guide is inserted into the semicircular canal, and the drug delivery guide is connected to the patient's ear. The base is fixedly connected, and the drug delivery catheter communicates with the inside of the drug delivery base;

所述微量给药器与给药装置可拆卸连接,所述微量给药器可连接导管扎入给药底座内部向其打药,可治疗内耳疾病。The micro-dosing device is detachably connected with the drug delivery device, and the micro-dosing device can be connected with a catheter and inserted into the drug delivery base to inject medicine to it, so as to treat inner ear diseases.

进一步,所述传动结构包括驱动电机、丝杠、固定板和移动块;所述固定板包括第一固定板和第二固定板;所述驱动电机与丝杠固定连接,所述固定板设置在丝杠两侧,所述丝杠与固定板转动连接,所述移动块设置在第一固定板与第二固定板之间,移动块与丝杠活动连接。Further, the transmission structure includes a driving motor, a lead screw, a fixed plate and a moving block; the fixed plate includes a first fixed plate and a second fixed plate; the drive motor is fixedly connected to the lead screw, and the fixed plate is arranged on On both sides of the lead screw, the lead screw is rotatably connected to the fixed plate, the moving block is arranged between the first fixed plate and the second fixed plate, and the moving block is movably connected to the lead screw.

进一步,所述驱动电机底部设置安装板,所述安装板上设置至少两个固定孔,驱动电机固定在给药装置外壳底部内侧,所述给药装置外壳底部内侧设置与固定孔适配的孔。Further, a mounting plate is provided at the bottom of the driving motor, and at least two fixing holes are provided on the mounting plate, the driving motor is fixed on the inner side of the bottom of the drug delivery device housing, and the inner side of the bottom of the drug delivery device housing is provided with a hole adapted to the fixing hole .

进一步,所述丝杠的长度大于第一固定板和第二固定板之间的距离。Further, the length of the lead screw is greater than the distance between the first fixing plate and the second fixing plate.

进一步,所述第一固定板和第二固定板中心设置通孔,所述通孔直径大于丝杠的直径,通孔内部均配置轴承,所述丝杠安装在轴承上,丝杠第二端伸出第二固定板的通孔与驱动电机固定连接。Further, a through hole is provided in the center of the first fixing plate and the second fixing plate, the diameter of the through hole is larger than the diameter of the lead screw, and bearings are arranged inside the through holes, the lead screw is installed on the bearing, and the second end of the lead screw The through hole protruding from the second fixing plate is fixedly connected with the driving motor.

进一步,所述第一固定板和第二固定板之间设置至少一个光杆;可选地,第一固定板和第二固定板之间设置两个光杆。Further, at least one polished rod is arranged between the first fixed plate and the second fixed plate; optionally, two polished rods are arranged between the first fixed plate and the second fixed plate.

进一步,所述移动块中心设置螺纹孔,所述螺纹孔与丝杠上的螺纹适配,移动块上设置与光杆适配的通孔;移动块设置在第一固定板和第二固定板之间,丝杠穿过螺纹孔,光杆穿过通孔;上述设置保证了丝杠转动时移动块可在第一固定板和第二固定板之间运动。Further, a threaded hole is provided in the center of the moving block, and the threaded hole is adapted to the thread on the lead screw, and a through hole adapted to the polished rod is provided on the moving block; the moving block is arranged between the first fixed plate and the second fixed plate Between them, the lead screw passes through the threaded hole, and the polished rod passes through the through hole; the above arrangement ensures that the moving block can move between the first fixed plate and the second fixed plate when the lead screw rotates.

进一步,所述移动块靠近给药装置外壳前侧面的一侧设置一连接杆,所述连接杆后端设置一打药块,所述打药块侧面设置一T型槽,所述T型槽贯穿打药块。Further, a connecting rod is provided on the side of the moving block close to the front side of the drug delivery device housing, a spraying block is provided at the rear end of the connecting rod, a T-shaped slot is provided on the side of the spraying block, and the T-shaped slot runs through the spraying block. piece.

进一步,所述给药装置外壳前侧面设置一槽型通孔,所述槽型通孔长度设置为与移动块的运动范围的长度相同。Further, a slot-shaped through hole is provided on the front side of the housing of the drug delivery device, and the length of the slot-shaped through hole is set to be the same as the length of the movement range of the moving block.

进一步,所述给药装置外壳前侧面槽型通孔侧面设置一弧形凹槽,所述弧形凹槽的弧度为120-180度,弧形凹槽与槽型通孔连接处设置一圆形凹槽,所述圆形凹槽垂直于给药装置外壳前侧面;可选地,弧形凹槽的弧度设置为180度。Further, an arc-shaped groove is arranged on the side of the slot-shaped through hole on the front side of the drug delivery device housing, and the arc-shaped groove has an arc of 120-180 degrees. shaped groove, the circular groove is perpendicular to the front side of the drug delivery device housing; optionally, the arc of the arc-shaped groove is set to 180 degrees.

进一步,所述给药装置外壳弧形凹槽下侧设置一卡死结构,所述卡死结构包括圆柱杆和卡死块;所述卡死块为长条状,所述卡死块的任意一侧设置一圆孔,所述卡死块设置在圆柱杆上,卡死块可沿着圆柱杆转动;所述卡死块与圆柱杆之间有摩擦力,在非人为操作时不会发生相对转动。Further, a locking structure is provided on the lower side of the arc-shaped groove of the housing of the drug delivery device, and the locking structure includes a cylindrical rod and a locking block; the locking block is elongated, and any of the locking blocks A round hole is set on one side, the stuck block is set on the cylindrical rod, and the blocked block can rotate along the cylindrical rod; there is friction between the stuck block and the cylindrical rod, which will not occur in non-human operation relative rotation.

进一步,所述给药装置外壳前侧面上部设置一显示屏,所述显示屏任意一侧设置开关和至少两个调节按钮,所述调节按钮可调节微量给药器的给药量和给药速度。Further, a display screen is provided on the upper front side of the housing of the drug delivery device, and a switch and at least two adjustment buttons are arranged on any side of the display screen, and the adjustment buttons can adjust the dosage and speed of the micro-dosing device. .

进一步,所述给药装置外壳内部设置控制系统,可控制驱动电机的转速和旋转时间,所述控制系统选用现有技术即可。Furthermore, a control system is set inside the housing of the drug delivery device, which can control the rotation speed and rotation time of the driving motor, and the control system can be selected from existing technologies.

进一步,所述给药装置外壳后端设置电源线,可为各个组件供电。Further, a power cord is provided at the rear end of the housing of the drug delivery device to supply power to each component.

进一步,所述微量给药器包括注射筒、注射部分和注射管;所述注射筒内部为中空,所述注射部分配置于注射筒内部,所述注射部分与注射筒活动连接,所述注射管设置在注射筒前端,所述注射管与注射筒可拆卸连接。注射筒内容积为30-50微升。Further, the micro-doser includes a syringe, an injection part and an injection tube; the interior of the syringe is hollow, the injection part is arranged inside the syringe, the injection part is movably connected with the syringe, and the injection tube It is arranged at the front end of the syringe, and the syringe is detachably connected with the syringe. The inner volume of the syringe is 30-50 microliters.

进一步,所述注射筒前端设置注射口,注射筒后端设置手持部,所述手持部可置入圆形凹槽内,所述注射筒的中间部分可置入弧形凹槽内,卡死结构可将注射筒固定,防止注射筒在注射药物时在弧形凹槽内掉出。Further, the front end of the syringe is provided with an injection port, and the rear end of the syringe is provided with a handle, the handle can be placed in a circular groove, the middle part of the syringe can be placed in an arc-shaped groove, and is stuck. The structure can fix the syringe to prevent the syringe from falling out in the arc-shaped groove when injecting medicine.

进一步,所述注射部分包括活塞、连杆和按压部,所述连杆第一端与活塞固定连接,所述连杆第二端与按压部固定连接,所述活塞与注射筒的内径相同,上述设置保证了推动按压部可将注射筒内的药物压出。Further, the injection part includes a piston, a connecting rod and a pressing part, the first end of the connecting rod is fixedly connected to the piston, the second end of the connecting rod is fixedly connected to the pressing part, the inner diameter of the piston is the same as that of the syringe, The above arrangement ensures that the drug in the syringe can be pushed out by pushing the pressing part.

进一步,所述注射管第一端与注射口适配,所述注射管第二端设置一穿刺针。Further, the first end of the injection tube is adapted to the injection port, and the second end of the injection tube is provided with a puncture needle.

进一步,所述给药底座内部为中空,给药底座上部设置软质材料,所述软质材料可选用硅胶,穿刺针可扎入患者皮肤穿过软质材料,药物可注射入给药底座经过给药导管流经半规管,达到治疗的效果。Further, the inside of the drug delivery base is hollow, and a soft material is provided on the upper part of the drug delivery base. The soft material can be made of silica gel. The puncture needle can be pierced into the patient's skin and pass through the soft material. The drug delivery catheter flows through the semicircular canal to achieve the therapeutic effect.

进一步,所述给药导管插入半规管的长度为8-16mm;可保证给药导管插入半规管时给药导管插得较深,不容易脱出;可选地,所述给药导管插入半规管的长度为10mm。Further, the length of the insertion of the drug delivery catheter into the semicircular canal is 8-16mm; it can ensure that the drug delivery catheter is inserted deeper when the drug delivery catheter is inserted into the semicircular canal, and it is not easy to come out; optionally, the length of the drug delivery catheter inserted into the semicircular canal is 10mm.

进一步,所述给药导管的直径0.1-0.3mm之间,可保证给药导管直径小于半规管的直径,给药导管可正常插入半规管。Further, the diameter of the drug delivery catheter is between 0.1-0.3 mm, which can ensure that the diameter of the drug delivery catheter is smaller than that of the semicircular canal, and the drug delivery catheter can be inserted into the semicircular canal normally.

进一步,所述给药导管为柔软的材料,所述给药导管的前端设置为圆滑状,防止给药导管插入半规管后前端将半规管再次刺破,导致将药物打入外淋巴液,起不到治疗的作用。Further, the drug delivery catheter is made of a soft material, and the front end of the drug delivery catheter is set in a smooth shape to prevent the front end of the drug delivery catheter from inserting the semicircular canal from puncturing the semicircular canal again, causing the drug to be injected into the perilymph, which cannot reach the desired effect. The role of treatment.

进一步,在置入所述给药导管前,先在三个半规管中任意一个开一个窗口,所述窗口设置在靠近半规管壶腹的位置,在给药导管插入半规管时,导管插入的方向背离半规管的壶腹。Further, before inserting the drug delivery catheter, open a window in any one of the three semicircular canals, the window is set at a position close to the ampulla of the semicircular canal, and when the drug delivery catheter is inserted into the semicircular canal, the direction of catheter insertion is away from the semicircular canal ampulla.

进一步,在所述给药导管距离前端10mm处设置一膨大部,所述膨大部直径大于半规管开口的直径;上述设置保证了给药导管置入后膨大部可卡在半规管的开口处,防止内淋巴液外漏,亦可防止给药导管在半规管内滑脱,这样对壶腹内部感受器的骚扰是最小的。Further, an enlarged part is set at 10 mm from the front end of the drug delivery catheter, and the diameter of the enlarged part is larger than the diameter of the opening of the semicircular canal; the above setting ensures that the enlarged part can be stuck at the opening of the semicircular canal after the drug delivery catheter is inserted, preventing internal The leakage of lymph fluid can also prevent the drug delivery catheter from slipping in the semicircular canal, so that the disturbance to the internal receptors of the ampulla is minimal.

进一步,植入时需使用动力钻磨除部分乳突骨质,暴露外半规管、前半规管和后半规管三个半规管中任意一个,并磨除半规管部分骨质进行开窗,暴露膜半规管,在三个半规管开窗处,显微尖针挑开膜半规管,为避免对内耳感受器的刺激,应背离壶腹方向插入;所述给药导管总长度设置为150mm,输液管可在乳突腔内进行盘曲。Furthermore, during implantation, part of the mastoid bone needs to be removed with a power drill to expose any of the three semicircular canals, the outer semicircular canal, the anterior semicircular canal, and the posterior semicircular canal. At the fenestration of the first semicircular canal, a microscopic sharp needle picks open the semicircular canal. In order to avoid stimulation to the inner ear receptors, it should be inserted away from the direction of the ampulla; Coiled.

本发明的有益效果:本发明通过设置给药装置,可对患者内耳进行可重复的精确的微量给药,为内耳疾病的药物治疗提供了可靠的给药途径。Beneficial effects of the present invention: the present invention can perform repeatable and accurate micro-dose to the inner ear of patients by setting the drug delivery device, and provides a reliable drug delivery route for the drug treatment of inner ear diseases.

附图说明Description of drawings

图1为本发明整体的结构示意图;Fig. 1 is the overall structural representation of the present invention;

图2为本发明给药装置和微量给药器配合的结构示意图;Fig. 2 is a structural schematic diagram of the coordination of the drug delivery device and the micro-dosing device of the present invention;

图3为本发明给药装置的结构示意图;3 is a schematic structural view of the drug delivery device of the present invention;

图4为本发明微量给药器安装在给药装置上时的剖视结构示意图;Fig. 4 is a schematic cross-sectional structural view of the micro-dosing device of the present invention when it is installed on the drug delivery device;

图5为本发明给药装置的剖视结构示意图;5 is a schematic cross-sectional structural view of the drug delivery device of the present invention;

图6为本发明移动块的结构示意图;Fig. 6 is a schematic structural diagram of a moving block of the present invention;

图7为本发明微量给药器的结构示意图;Fig. 7 is a schematic structural view of the micro-dosing device of the present invention;

图8为本发明给药装置的结构示意图;Figure 8 is a schematic structural view of the drug delivery device of the present invention;

图9为本发明给药装置的剖视结构示意图;9 is a schematic cross-sectional structural view of the drug delivery device of the present invention;

图10为本发明给药装置置入皮下后的结构示意图;Fig. 10 is a schematic structural view of the drug delivery device of the present invention after it is placed under the skin;

图中,1、给药装置外壳;2、微量给药器;3、给药底座;4、给药导管;5、驱动电机;6、丝杠;7、固定板;8、移动块;9、光杆;10、螺纹孔;11、连接杆;12、打药块;13、槽型通孔;14、弧形凹槽;15、圆形凹槽;16、圆柱杆;17、卡死块;18、显示屏;19、开关;20、调节按钮;21、电源线;22、注射筒;24、T型槽;25、注射管;26、手持部;27、活塞;28、连杆;29、按压部;30、穿刺针;31、壶腹;32、半规管。In the figure, 1. Drug delivery device shell; 2. Micro-dosing device; 3. Drug delivery base; 4. Drug delivery catheter; 5. Driving motor; 6. Lead screw; 7. Fixed plate; 8. Moving block; 9 1. Polished rod; 10. Threaded hole; 11. Connecting rod; 12. Spraying block; 13. Groove through hole; 14. Arc groove; 15. Circular groove; 16. Cylindrical rod; 17. Blocking block; 18. Display screen; 19. Switch; 20. Adjustment button; 21. Power cord; 22. Injection barrel; 24. T-shaped slot; 25. Injection tube; 26. Handpiece; 27. Piston; 28. Connecting rod; 29 , compression part; 30, puncture needle; 31, ampulla; 32, semicircular canal.

具体实施方式Detailed ways

以下通过特定的具体实施例对本发明实施例中的技术方案进行清楚、完整地描述,显然,所描述的实施例仅仅是本发明一部分实施例,而不是全部的实施例,本领域技术人员可由本说明书所揭露的内容轻易地了解本发明的其他优点与功效。本发明还可以通过另外不同的具体实施方式加以实施或应用,在不冲突的情况下,以下实施例及实施例中的特征可以相互组合,基于本发明中的实施例,本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例,都属于本发明保护的范围。The technical solutions in the embodiments of the present invention are clearly and completely described below through specific specific embodiments. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all embodiments. Those skilled in the art can learn from this Other advantages and functions of the present invention can be easily understood from the contents disclosed in the specification. The present invention can also be implemented or applied through other different specific implementation modes. In the case of no conflict, the following embodiments and the features in the embodiments can be combined with each other. Based on the embodiments of the present invention, those of ordinary skill in the art will All other embodiments obtained under the premise of no creative work belong to the protection scope of the present invention.

实施例1Example 1

请参照图1-10,本实施例中的一种皮下植入式经半规管32内耳重复给药装置,其包括:Please refer to Fig. 1-10, a kind of subcutaneous implantable inner ear repetitive drug delivery device through the semicircular canal 32 in this embodiment, which includes:

给药装置,用于精确推动微量给药器2进行精确给药;其包括给药装置外壳1和传动结构,传动结构设置在给药装置外壳1内部。The drug delivery device is used to accurately push the micro-dosing device 2 for precise drug delivery; it includes a drug delivery device housing 1 and a transmission structure, and the transmission structure is arranged inside the drug delivery device housing 1 .

微量给药器2,用于吸取治疗药物并将药物打出,将药物打入患者皮下的给药装置。The micro-dosing device 2 is used to draw the therapeutic medicine and eject the medicine, and inject the medicine into the subcutaneous administration device of the patient.

给药装置;其包括给药底座3和给药导管4,给药底座3埋至患者耳后,给药导管4设置在患者耳朵内部,给药导管4的末端插入半规管32,给药导管4与给药底座3固定连接,给药导管4与给药底座3内部相通。Drug delivery device; it includes a drug delivery base 3 and a drug delivery catheter 4, the drug delivery base 3 is buried behind the patient's ear, the drug delivery guide 4 is arranged inside the patient's ear, the end of the drug delivery guide 4 is inserted into the semicircular canal 32, and the drug delivery guide 4 It is fixedly connected with the dosing base 3, and the dosing conduit 4 communicates with the inside of the dosing base 3.

微量给药器2与给药装置可拆卸连接,微量给药器2可连接导管扎入给药底座3内部向其打药,可治疗内耳疾病。The micro-dosing device 2 is detachably connected with the drug delivery device, and the micro-dosing device 2 can be connected to a catheter and inserted into the drug delivery base 3 to dispense medicine to it, which can treat inner ear diseases.

实施例2Example 2

请参照图1-6,在实施例1的基础上,本实施例增加以下技术特征:(对给药装置的结构进行以下具体设置):传动结构包括驱动电机5、丝杠6、固定板7和移动块8;固定板7包括第一固定板和第二固定板;驱动电机5与丝杠6固定连接,固定板7设置在丝杠6两侧,丝杠6与固定板7转动连接,移动块8设置在第一固定板与第二固定板之间,移动块8与丝杠6活动连接。Please refer to Figures 1-6, on the basis of Embodiment 1, this embodiment adds the following technical features: (The structure of the drug delivery device is specifically set as follows): the transmission structure includes a drive motor 5, a lead screw 6, and a fixed plate 7 and the moving block 8; the fixed plate 7 includes a first fixed plate and a second fixed plate; the driving motor 5 is fixedly connected with the leading screw 6, the fixed plate 7 is arranged on both sides of the leading screw 6, and the leading screw 6 is connected with the fixed plate 7 in rotation, The moving block 8 is arranged between the first fixing plate and the second fixing plate, and the moving block 8 is movably connected with the lead screw 6 .

驱动电机5底部设置安装板,安装板上设置至少两个固定孔,驱动电机5固定在给药装置外壳1底部内侧,给药装置外壳1底部内侧设置与固定孔适配的孔。A mounting plate is provided at the bottom of the drive motor 5, and at least two fixing holes are provided on the mounting plate. The drive motor 5 is fixed on the inside of the bottom of the drug delivery device housing 1, and the inside of the bottom of the drug delivery device housing 1 is provided with a hole adapted to the fixing holes.

丝杠6的长度大于第一固定板和第二固定板之间的距离。The length of the lead screw 6 is greater than the distance between the first fixing plate and the second fixing plate.

第一固定板和第二固定板中心设置通孔,通孔直径大于丝杠6的直径,通孔内部均配置轴承,丝杠6安装在轴承上,丝杠6第二端伸出第二固定板的通孔与驱动电机5固定连接。The center of the first fixed plate and the second fixed plate is provided with a through hole, the diameter of the through hole is greater than the diameter of the screw 6, and the inside of the through hole is equipped with a bearing, the screw 6 is installed on the bearing, and the second end of the screw 6 extends out of the second fixed The through hole of the plate is fixedly connected with the drive motor 5 .

第一固定板和第二固定板之间设置至少一个光杆9;可选地,第一固定板和第二固定板之间设置两个光杆9。At least one polished rod 9 is arranged between the first fixed plate and the second fixed plate; optionally, two polished rods 9 are arranged between the first fixed plate and the second fixed plate.

移动块8中心设置螺纹孔10,螺纹孔10与丝杠6上的螺纹适配,移动块8上设置与光杆9适配的通孔;移动块8设置在第一固定板和第二固定板之间,丝杠6穿过螺纹孔10,光杆9穿过通孔;上述设置保证了丝杠6转动,移动块8可在第一固定板和第二固定板之间运动。A threaded hole 10 is set in the center of the moving block 8, and the threaded hole 10 is adapted to the thread on the lead screw 6, and a through hole adapted to the polished rod 9 is set on the moving block 8; the moving block 8 is arranged on the first fixed plate and the second fixed plate Between them, the lead screw 6 passes through the threaded hole 10, and the polished rod 9 passes through the through hole; the above arrangement ensures that the lead screw 6 rotates, and the moving block 8 can move between the first fixed plate and the second fixed plate.

移动块8靠近给药装置外壳1前侧面的一侧设置一连接杆11,连接杆11后端设置一打药块12,打药块12侧面设置一T型槽24,T型槽24贯穿打药块12。A connecting rod 11 is arranged on the side of the moving block 8 close to the front side of the drug delivery device housing 1, a spraying block 12 is arranged at the rear end of the connecting rod 11, and a T-shaped groove 24 is arranged on the side of the spraying block 12, and the T-shaped groove 24 runs through the spraying block 12 .

给药装置外壳1前侧面设置一槽型通孔13,槽型通孔13长度设置为移动块8的运动范围。A slot-shaped through hole 13 is provided on the front side of the drug delivery device housing 1 , and the length of the slot-shaped through hole 13 is set to the range of movement of the moving block 8 .

给药装置外壳1前侧面槽型通孔13侧面设置一弧形凹槽14,弧形凹槽14的弧度为120-180度,弧形凹槽14与槽型通孔13连接处设置一圆形凹槽15,圆形凹槽15垂直于给药装置外壳1前侧面;可选地,弧形凹槽14的弧度设置为180度。An arc-shaped groove 14 is arranged on the side of the slot-shaped through hole 13 on the front side of the drug delivery device housing 1. The arc of the arc-shaped groove 14 is 120-180 degrees. A circular groove 15, the circular groove 15 is perpendicular to the front side of the drug delivery device housing 1; optionally, the radian of the arc-shaped groove 14 is set to 180 degrees.

给药装置外壳1弧形凹槽14下侧设置一卡死结构,卡死结构包括圆柱杆16和卡死块17;卡死块17为长条状,卡死块17的任意一侧设置一圆孔,卡死块17设置在圆柱杆16上,卡死块17可沿着圆柱杆16转动;卡死块17与圆柱杆16之间有摩擦力,在非人为操作时不会发生相对转动。A locking structure is arranged on the lower side of the arc-shaped groove 14 of the drug delivery device housing 1, and the locking structure includes a cylindrical rod 16 and a locking block 17; Round hole, the stuck block 17 is arranged on the cylindrical rod 16, and the blocked block 17 can rotate along the cylindrical rod 16; there is friction between the stuck block 17 and the cylindrical rod 16, and there will be no relative rotation during non-human operation .

给药装置外壳1前侧面上部设置一显示屏18,显示屏18任意一侧设置开关19和至少两个调节按钮20,调节按钮20可调节微量给药器2的给药量和给药速度。A display screen 18 is arranged on the top of the front side of the drug delivery device housing 1, and any side of the display screen 18 is provided with a switch 19 and at least two adjustment buttons 20.

给药装置外壳1内部设置控制系统,可控制驱动电机5的转速和旋转时间,控制系统选用现有技术即可。A control system is arranged inside the drug delivery device housing 1, which can control the rotational speed and rotation time of the drive motor 5, and the control system can be selected from the prior art.

给药装置外壳1后端设置电源线21,可为各个组件供电。The rear end of the drug delivery device housing 1 is provided with a power cord 21, which can supply power to each component.

实施例3Example 3

请参照图1-2,4,7,在实施例1-2的基础上,本实施例增加以下技术特征(对微量给药器2的结构进行以下具体设置):微量给药器2包括注射筒22、注射部分和注射管25;注射筒22内部为中空,注射部分配置于注射筒22内部,注射部分与注射筒22活动连接,注射管25设置在注射筒22前端,注射管25与注射筒22可拆卸连接。注射筒22内容积为30-50微升,内耳感受器浸泡在内淋巴液内,内淋巴液的总量约为34微升。Please refer to Figures 1-2, 4, and 7. On the basis of Embodiment 1-2, this embodiment adds the following technical features (the following specific settings are made to the structure of the micro-doser 2): the micro-doser 2 includes injection Cylinder 22, injection part and injection tube 25; The inside of the injection tube 22 is hollow, the injection part is arranged inside the injection tube 22, the injection part is movably connected with the injection tube 22, the injection tube 25 is arranged at the front end of the injection tube 22, and the injection tube 25 is connected with the injection tube 22. The cartridge 22 is detachably attached. The inner volume of the syringe 22 is 30-50 microliters, and the inner ear receptors are soaked in the endolymph, and the total amount of the endolymph is about 34 microliters.

注射筒22前端设置注射口,注射筒22后端设置手持部26,手持部26可置入圆形凹槽15内,注射筒22的中间部分可置入弧形凹槽14内,卡死结构可将注射筒22固定,防止注射筒22在注射药物时在弧形凹槽14内掉出。The front end of the syringe 22 is provided with an injection port, and the rear end of the syringe 22 is provided with a handle 26. The handle 26 can be placed in the circular groove 15, and the middle part of the syringe 22 can be placed in the arc groove 14. The syringe 22 can be fixed to prevent the syringe 22 from falling out of the arc groove 14 when injecting medicine.

注射部分包括活塞27、连杆28和按压部29,连杆28第一端与活塞27固定连接,连杆28第二端与按压部29固定连接,活塞27与注射筒22的内径相同,上述设置保证了推动按压部29可将注射筒22内的药物压出。The injection part includes a piston 27, a connecting rod 28 and a pressing part 29. The first end of the connecting rod 28 is fixedly connected to the piston 27, the second end of the connecting rod 28 is fixedly connected to the pressing part 29, and the inner diameter of the piston 27 is the same as that of the injection cylinder 22. The arrangement ensures that pushing the pressing part 29 can push out the medicine in the syringe 22 .

注射管25第一端与注射口适配,注射管25第二端设置一穿刺针30。The first end of the injection tube 25 is adapted to the injection port, and the second end of the injection tube 25 is provided with a puncture needle 30 .

实施例4Example 4

请参照图1,8-10,在实施例1-3的基础上,本实施例增加以下技术特征(对给药装置的结构进行以下具体设置):给药底座3内部为中空,给药底座3上部设置软质材料,软质材料可选用硅胶,穿刺针30可扎入患者皮肤穿过软质材料,药物可注射入给药底座3经过给药导管4流经半规管32,达到治疗的效果。Please refer to Fig. 1, 8-10, on the basis of embodiment 1-3, this embodiment adds the following technical features (the structure of the drug delivery device is specifically set as follows): the inside of the drug delivery base 3 is hollow, and the drug delivery base 3 The upper part is provided with a soft material, the soft material can be made of silica gel, the puncture needle 30 can be pierced into the patient's skin and pass through the soft material, and the medicine can be injected into the drug delivery base. .

给药导管4插入半规管32的长度为8-16mm;可保证给药导管4插入半规管32时给药导管4插得较深,不容易脱出;可选地,给药导管4插入半规管32的长度为10mm。The length of the drug delivery catheter 4 inserted into the semicircular canal 32 is 8-16mm; when the drug delivery catheter 4 is inserted into the semicircular canal 32, the drug delivery catheter 4 is inserted deeply, and it is not easy to come out; optionally, the drug delivery catheter 4 is inserted into the semicircular canal 32. 10mm.

给药导管4的直径0.1-0.3mm之间,可保证给药导管4直径小于半规管32的直径,给药导管4可正常插入半规管32。The diameter of the drug delivery catheter 4 is between 0.1-0.3mm, which can ensure that the diameter of the drug delivery catheter 4 is smaller than the diameter of the semicircular canal 32, and the drug delivery catheter 4 can be inserted into the semicircular canal 32 normally.

给药导管4为柔软的材料,给药导管4的前端设置为圆滑状,防止给药导管4插入半规管32后前端将半规管32再次刺破,导致将药物打入外淋巴液,起不到治疗的作用。The drug delivery catheter 4 is made of soft material, and the front end of the drug delivery catheter 4 is set in a smooth shape to prevent the front end of the drug delivery catheter 4 from inserting into the semicircular canal 32 to puncture the semicircular canal 32 again, causing the medicine to be injected into the perilymph, thus failing to achieve treatment role.

在置入给药导管4前,先在三个半规管32中任意一个开一个窗口,窗口设置在靠近半规管32壶腹31的位置,在给药导管4插入半规管32时,导管插入的方向背离半规管32的壶腹31;优选地,最好选用外半规管,其他两个半规管32在手术中暴露相对比较困难。Before inserting the drug delivery catheter 4, open a window in any one of the three semicircular canals 32, the window is set near the ampulla 31 of the semicircular canal 32, when the drug delivery catheter 4 is inserted into the semicircular canal 32, the direction of catheter insertion deviates from the semicircular canal 32 of the ampulla 31; preferably, the best selection of the outer semicircular canal, the other two semicircular canals 32 are relatively difficult to expose during surgery.

在给药导管4距离前端10mm处设置一膨大部,膨大部直径大于半规管32开口的直径;上述设置保证了给药导管4置入后膨大部可卡在半规管32的开口处,防止给药导管4在半规管32内滑脱,这样对壶腹31内部感受器的骚扰是最小的。A swollen part is set at 10 mm from the front end of the drug delivery catheter 4, and the diameter of the swollen part is greater than the diameter of the opening of the semicircular canal 32; 4 slips within the semicircular canal 32 so that disturbance of the internal receptors of the ampulla 31 is minimal.

给药导管4植入时使用动力钻磨除部分乳突骨质,暴露外半规管、前半规管和后半规管三个半规管32中任意一个,并磨除半规管32部分骨质进行开窗,暴露膜半规管32,在三个半规管32开窗处,显微尖针挑开膜半规管32,为避免对内耳感受器的刺激,应背离半规管32壶腹31方向插入给药导管4;给药导管4总长度设置为150mm,输液管可在乳突腔内进行盘曲。When the drug delivery catheter 4 is implanted, use a power drill to grind away part of the mastoid bone, expose any one of the three semicircular canals 32 of the outer semicircular canal, anterior semicircular canal, and posterior semicircular canal, and grind away part of the semicircular canal 32 to open a window to expose the membranous semicircular canal 32. At the window openings of the three semicircular canals 32, the microscopic sharp needle picks open the membrane semicircular canals 32. In order to avoid stimulation to the inner ear receptors, the drug delivery catheter 4 should be inserted in the direction away from the ampulla 31 of the semicircular canal 32; the total length of the drug delivery catheter 4 is set 150mm, the infusion tube can be coiled in the mastoid cavity.

先将给药装置安装固定于皮下后,给药导管4植入半规管32内部,微量给药器2抽入药物后,将微量给药器2连接在皮下的给药装置上,打药装置可调节打药量,调节好打药量后将微针给药器后端的穿刺针30刺入患者耳后皮肤,刺入至给药装置中。After the drug delivery device is installed and fixed under the skin, the drug delivery catheter 4 is implanted inside the semicircular canal 32, and after the micro-dosing device 2 draws in the medicine, the micro-dosing device 2 is connected to the subcutaneous drug delivery device, and the drug injection device can be adjusted Dosing amount, after adjusting the dosing amount, pierce the puncture needle 30 at the rear end of the microneedle applicator into the skin behind the ear of the patient, and pierce into the drug delivery device.

上述实施例的说明只是用于理解本发明。应当指出,对于本领域的普通技术人员来说,在不脱离本发明原理的前提下,还可以对本发明进行若干改进,这些改进也将落入本发明权利要求的保护范围内。The above descriptions of the embodiments are only for the understanding of the present invention. It should be pointed out that those skilled in the art can make some improvements to the present invention without departing from the principles of the present invention, and these improvements will also fall within the protection scope of the claims of the present invention.

Claims (10)

1. A subcutaneously implantable semi-structured inner ear repeat administration device comprising:
the drug delivery device is used for accurately pushing the micro drug delivery device to accurately deliver drugs; the drug delivery device comprises a drug delivery device shell and a transmission structure, wherein the transmission structure is arranged inside the drug delivery device shell;
a micro-drug delivery device for sucking therapeutic drug and delivering the drug out, and delivering the drug into subcutaneous drug delivery device of patient;
a drug delivery device; the device comprises a drug delivery base and a drug delivery catheter, wherein the drug delivery catheter is arranged inside the ear of a patient after the drug delivery base is buried in the ear of the patient, the tail end of the drug delivery catheter is inserted into a semicircular canal, the drug delivery catheter is fixedly connected with the drug delivery base, and the drug delivery catheter is communicated with the inside of the drug delivery base;
the micro-drug delivery device is detachably connected with the drug delivery device, and can be connected with a catheter to be pricked into the drug delivery base to deliver drugs to the drug delivery base, so that inner ear diseases can be treated.
2. The subcutaneously implantable semi-regulated in-canal re-administration device according to claim 1, wherein the transmission structure comprises a driving motor, a screw, a fixed plate and a moving block; the fixing plate comprises a first fixing plate and a second fixing plate; the driving motor is fixedly connected with the screw rod, the fixed plates are arranged on two sides of the screw rod, the screw rod is rotationally connected with the fixed plates, the moving block is arranged between the first fixed plate and the second fixed plate, and the moving block is movably connected with the screw rod; the bottom of the driving motor is provided with a mounting plate, the mounting plate is provided with at least two fixing holes, the driving motor is fixed on the inner side of the bottom of the shell of the drug delivery device, and the inner side of the bottom of the shell of the drug delivery device is provided with a hole matched with the fixing hole; the length of the screw rod is longer than the distance between the first fixing plate and the second fixing plate.
3. The subcutaneous implantable through-semicircular canal inner ear repeated administration device according to claim 2, wherein the centers of the first fixing plate and the second fixing plate are provided with through holes, the diameter of each through hole is larger than that of a lead screw, bearings are arranged in the through holes, the lead screws are arranged on the bearings, and the through holes, extending out of the second fixing plate, of the second ends of the lead screws are fixedly connected with a driving motor; at least one polish rod is arranged between the first fixing plate and the second fixing plate; two polish rods are arranged between the first fixing plate and the second fixing plate; the center of the moving block is provided with a threaded hole which is matched with the threads on the screw rod, and the moving block is provided with a through hole which is matched with the polish rod; the movable block is arranged between the first fixed plate and the second fixed plate, the screw rod penetrates through the threaded hole, and the polish rod penetrates through the through hole.
4. The subcutaneous implantable semi-structured inner ear repeated administration device according to claim 2, wherein a connecting rod is arranged on one side of the movable block, which is close to the front side surface of the administration device shell, a medicine beating block is arranged at the rear end of the connecting rod, a T-shaped groove is arranged on the side surface of the medicine beating block, and the T-shaped groove penetrates through the medicine beating block; the front side surface of the shell of the drug delivery device is provided with a groove-shaped through hole, and the length of the groove-shaped through hole is equal to the length of the movement range of the moving block; the side of the groove-type through hole on the front side of the shell of the drug delivery device is provided with an arc-shaped groove, the radian of the arc-shaped groove is 120-180 degrees, the joint of the arc-shaped groove and the groove-type through hole is provided with a circular groove, and the circular groove is perpendicular to the front side of the shell of the drug delivery device.
5. The subcutaneous implantable semi-structured inner ear repeat drug delivery device according to claim 1, wherein a locking structure is arranged at the lower side of the arc-shaped groove of the drug delivery device shell, and the locking structure comprises a cylindrical rod and a locking block; the clamping block is in a strip shape, a round hole is formed in any side of the clamping block, the clamping block is arranged on the cylindrical rod, and the clamping block can rotate along the cylindrical rod; friction is arranged between the clamping block and the cylindrical rod.
6. The subcutaneous implantable semi-structured inner ear repeated administration device according to claim 1, wherein a display screen is provided at the upper part of the front side of the administration device housing, a switch and at least two adjusting buttons are provided at either side of the display screen, and the adjusting buttons can adjust the administration amount and the administration speed of the microdose; the medicine feeding device is characterized in that a control system is arranged in the casing of the medicine feeding device, and the rotating speed and the rotating time of the driving motor can be controlled.
7. The subcutaneously implantable semi-structured inner ear repeat administration device according to claim 5, wherein the microdose comprises a syringe, an injection section and a syringe; the injection part is arranged in the injection cylinder, the injection part is movably connected with the injection cylinder, the injection pipe is arranged at the front end of the injection cylinder, and the injection pipe is detachably connected with the injection cylinder; the volume of the injection tube is 30-50 microliters; the front end of the injection tube is provided with an injection port, the rear end of the injection tube is provided with a hand-held part, the hand-held part can be placed in the circular groove, the middle part of the injection tube can be placed in the arc groove, and the injection tube can be fixed by the clamping structure; the injection part comprises a piston, a connecting rod and a pressing part, wherein the first end of the connecting rod is fixedly connected with the piston, the second end of the connecting rod is fixedly connected with the pressing part, and the inner diameter of the piston is the same as that of the injection cylinder; the first end of the injection tube is matched with the injection port, and the second end of the injection tube is provided with a puncture needle.
8. The subcutaneous implantable device for repeated administration of a substance through the inner ear of a semicircular canal according to claim 1, wherein a power drill is used for removing part of mastoid bone during implantation, any one of the three semicircular canals of the outer semicircular canal, the front semicircular canal and the rear semicircular canal is exposed, and the semicircular canal is removed for windowing, the membrane semicircular canal is exposed, and a microtip is used for picking up the membrane semicircular canal and inserting the administration catheter away from the ampulla direction of the semicircular canal; the total length of the administration catheter is set to be 150mm, and the infusion tube can be coiled in the mastoid cavity.
9. The subcutaneous implantable device for repeated administration of a medicament through a semicircular canal according to claim 7, wherein the interior of the administration base is hollow, a soft material is arranged at the upper part of the administration base, the puncture needle can be inserted into the skin of a patient to pass through the soft material, and the medicament can be injected into the administration base to flow through the semicircular canal through the administration catheter, so that the therapeutic effect is achieved; the length of the administration catheter insertion semicircular canal is 8-16mm; the diameter of the administration conduit is between 0.1 and 0.3 mm; the administration catheter is made of soft materials, and the front end of the administration catheter is smooth.
10. The subcutaneous implantable device for repeated administration via the inner ear of a semicircular canal according to any one of claims 1 to 9, wherein a window is formed in any one of the three semicircular canals before the administration line is placed, the window is disposed at a position close to the ampulla of the semicircular canal, and an enlarged portion having a diameter larger than that of the opening of the semicircular canal is disposed at a position 10mm from the front end of the administration line.
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