WO2015018294A1 - 视网膜下腔干细胞移植器 - Google Patents

视网膜下腔干细胞移植器 Download PDF

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Publication number
WO2015018294A1
WO2015018294A1 PCT/CN2014/083389 CN2014083389W WO2015018294A1 WO 2015018294 A1 WO2015018294 A1 WO 2015018294A1 CN 2014083389 W CN2014083389 W CN 2014083389W WO 2015018294 A1 WO2015018294 A1 WO 2015018294A1
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WIPO (PCT)
Prior art keywords
stem cell
subretinal
linear motor
needle
storage tube
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PCT/CN2014/083389
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English (en)
French (fr)
Inventor
彭广华
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中国人民解放军总医院
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Publication of WO2015018294A1 publication Critical patent/WO2015018294A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically

Definitions

  • the invention belongs to the field of medical devices, and in particular to a subretinal stem cell transplanter for surgery in clinical and experimental ophthalmology.
  • the most common blinding eye diseases at present include cataracts, corneal diseases, glaucoma and retinal degenerative diseases (including age-related macular degeneration, retinitis pigmentosa, diabetic retinopathy, and retinal degeneration caused by high myopia).
  • the first cause of blindness (60%) of cataracts can be recovered by the increasingly sophisticated modern cataract extraction and intraocular lens implantation; glaucoma is controlled primarily by early prevention and later drug or surgery, partially meeting the patient's quality of life.
  • Retinal degenerative diseases are the most common cause of blindness in developed countries (more than 50%). Nearly 200,000 people are blinded by such diseases every year in China, which is a serious blinding eye disease that has no effective treatment in the world.
  • micro-injectors for transepithelial stem cell transplantation. Due to the long micro-injector (generally metal needle length 30mm, glass needle length 85mm, whole syringe length 128mm), the surgeon puts the injection needle Inserted under the retina After the cavity, holding the syringe, the assistant needs a needle handle to inject the stem cells into the subretinal space. Common complications of the application of such microinjectors are:
  • the microscopic needle can easily penetrate the retina into the vitreous cavity, and the retinal blood vessels can cause retinal hemorrhage. In severe cases, the blood in the eye can be caused, resulting in failure of the subretinal transplantation.
  • the success rate of microinjector for subretinal stem cell transplantation is about 40-50%.
  • the sterilizing of the syringe is usually 0. 184 ⁇ 0. 36mm, the inner diameter is 0. 0826 ⁇ 0. 184mm, the disinfection of the syringe is often used because the needle is in the form of a needle and a syringe. With the disinfectant soaking method, autoclaving can cause the sharpness of the injection needle to drop.
  • the present invention provides a subretinal stem cell transplanter which is simple, safe and reliable.
  • Designing a subretinal stem cell transplanter comprising a needle, a cannula, a power injection tube, a screw cap, the needle, the sleeve, the injection power propulsion tube, and the screw cap are sequentially connected and connected.
  • the transplanter further includes a linear motor, a power source for driving the linear motor, a control switch for controlling the start and stop of the linear motor, a quantitative storage tube installed in the sleeve for pre-installing stem cells, and a limit installed in the injection power propulsion tube a position fixing member, wherein the limiting fixing member is provided with a guiding hole, the primary mounting of the linear motor is fixed in the injection power propulsion tube, and the secondary end of the linear motor passes through the guiding of the limiting fixing member a pusher is fixedly connected to the rear of the hole, one end of the quantitative storage tube is correspondingly connected to the needle, the other end is provided with a piston, and the piston corresponds to the pusher, and the control switch is mounted on the sleeve Close to the front section of the needle.
  • the symmetrical portion of the storage tube sleeve is provided with a slit-length see-through window, and a scale is provided on the longitudinal axis of the outer tube wall of the quantitative storage tube.
  • the control switch is 10 to 20 mm away from the front end of the quantitative storage tube sleeve.
  • the quantitative quantitative storage tube is made of medical glass
  • the type of the needle is any one of 28G, 30G, 31G, 32G, and 34G.
  • a spring abutting the secondary of the linear motor is disposed in the cap.
  • the control switch is a touch switch, and is provided with forward, stop, and back buttons respectively.
  • the screw cap is provided with strip-shaped protrusions.
  • the power source for driving the linear motor is a built-in power source provided in the screw cap or an external power source.
  • the subretinal stem cell transplanter of the present invention overcomes the risk of breaking the retina caused by the uncoordinated operation of the two people, and creates a transplanter which is simple, easy to operate, and not easy to contaminate, which significantly reduces the difficulty of transplantation and improves the retina.
  • the effect of transplanting stem cells in the lower cavity is very important.
  • the needle and the syringe of the subretinal stem cell transplanter of the present invention may be separated
  • the needle can be disposable, which can overcome the sharpness of the injection needle caused by autoclaving, and avoid the slenderness of the inner diameter of the needle. It is not easy to clean after use, and the solution soaking can easily cause incomplete disinfection, thus causing the problem of surgical contamination. .
  • the operator can operate the injection process by himself, without the need to cooperate with the assistant, and avoid the situation that the delicate needle easily penetrates the retina into the vitreous cavity during the fitting process, and wears Retinal hemorrhage caused by retinal blood vessels, causing intraocular hemorrhage in severe cases, causing failure of subretinal transplantation.
  • the success rate of subretinal stem cell transplantation with a micro syringe is about 40 ⁇ 50%.
  • the subretinal stem cell transplanter of the present invention Increased the success rate of subretinal stem cell transplantation.
  • Figure 1 is a perspective view of a subretinal stem cell transplanter of the present invention
  • Figure 2 is a cross-sectional view of the subretinal stem cell transplanter of the present invention.
  • 1 is a needle
  • 2 is a quantitative storage tube
  • 3 is a sleeve
  • 4 is a piston
  • 5 is a pusher
  • 6 is a limit fixture
  • 7 is a injection power propulsion tube
  • 8 is a linear motor primary
  • 9 It is a linear motor secondary
  • 10 is a screw cap
  • 11 is a spring
  • 12 is a control switch
  • 13 is a pilot hole.
  • Example 1 A subretinal stem cell transplanter, see Fig. 1, Fig. 2, including needle (30G) 1.
  • the sleeve 3 is snapped, the sleeve 3 and the injection power propulsion
  • the tube 7 is end-threaded, the limiting fixture 6 is fixedly mounted on the inner wall of the injection power propulsion tube 7, and the limiting fixing member 6 is provided with a guiding hole 13 in which the primary 8 of the linear induction motor is fixed.
  • one end of the secondary motor 9 of the linear induction motor passes through the guide hole 13 of the limiting fixture 6, and is provided with a pushing member 5 at its end, the cap 10 and the injection power propulsion pipe 7 Threaded connection, the control switch 12 is mounted on the front section of the sleeve 3.
  • the sleeve 3 is symmetrically opened on both sides with a slit window, and a scale is provided on the longitudinal axis of the outer tube wall of the storage tube sleeve 3.
  • the control switch 12 is 15 mm from the front end of the sleeve 3, 10 mm long, and 4 mm wide.
  • the quantitative storage tube 2 is made of medical glass; the screw cap 10 is placed at the end of the injection power propulsion tube 7 with a spring 11.
  • the cap 10 is provided with strip-like projections for preventing slip.
  • the above subretinal stem cell transplanter is used as follows:
  • the storage tube with the quantitative stem cells is inserted in the storage tube sleeve, the needle is mounted on the front end of the storage tube sleeve, the finger is pressed by the switch during injection, and the linear induction motor with the piston pushes the piston of the quantitative stem cell storage tube. Move forward, inject the stem cells in the quantitative storage tube into the lower retina, and press the reset switch to reset the secondary in the linear motor. Because of the scale on the casing of the storage tube, the injector can shut down the linear motor to control the amount of injection.
  • the quantitative storage tube can also be made into different volumes of dry cells to carry the storage tube according to the volume of the transplanted stem cells, and the quantitative storage tube to be used can be selected according to the amount of the injection, so that the accuracy of the injection amount can be controlled.

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

一种视网膜下腔干细胞移植器，包括依次安装连接的针头（1）、套管（3）、注射动力推进管（7）、旋盖（10），该移植器还包括直线电机、电源、控制开关（12）、安装于该套管（3）的用于预装干细胞的定量储藏管（2）和限位固定件（6），限位固定件（6）内设有导向孔，直线电机的初级（8）安装固定于注射动力推进管（7）内，其次级（9）一端穿过限位固定件（6）的导向孔后固定连接推压件（5），定量储藏管（2）一端对应地连通于针头（1），其另一端置有活塞（4），且该活塞（4）对应于推压件（5），控制开关（12）安装在所述套管（3）上靠近针头（1）的前段区域。该移植器操作简单，安全可靠，克服了两人操作不协调带来的穿破视网膜的风险，明显降低了移植难度，提高了视网膜下腔移植干细胞的效果。

Description

视网膜下腔干细胞移植器
技术领域
本发明属于医疗器材领域， 特别是涉及临床和实验眼科学中手术 用的视网膜下腔干细胞移植器。
技术背景
目前最常见的致盲性眼病包括白内障、 角膜病、 青光眼和视网膜变 性疾病 （包括老年性黄斑变性， 视网膜色素变性， 糖尿病视网膜病变和 高度近视导致的视网膜变性等）。 其中占首位致盲原因 （60% ) 的白内障 可经日益完善的现代白内障摘除人工晶体植入手术而复明； 青光眼主要 通过早期预防和后期药物或手术得以控制， 部分满足患者的生存质量。 视网膜变性疾病是发达国家致盲的最常见原因 （超过 50%)， 我国每年因 此类疾病失明的患者近 20万， 是目前国际上尚无有效治疗手段的严重致 盲性眼病。 因此， 为视网膜变性疾病这类发病率高、 危害重的致盲眼病 找到治疗手段， 是我国经济、 社会和人民健康的重大需求。 研究发现， 在视网膜变性疾病发生发展过程中， 首先是视网膜色素上皮细胞 （RPE ) 和感光细胞的变性死亡。 因此， 感光细胞和 RPE的替代治疗是重建视网 膜功能的关键靶细胞。 研究表明， 干细胞替代治疗的可操作性和移植后 视功能的易观察性使干细胞介导的再生治疗正在成为严重致盲性眼病的 临床治疗策略。
目前， 国内外眼科学的临床医生和研究人员常用微量注射器进行视 网膜下腔干细胞移植， 由于微量注射器较长 （一般金属针头长 30mm， 玻 璃针管长 85mm， 整个注射器长 128mm )， 手术者把注射针头插入视网膜下 腔后， 手持注射器， 需要助手压针柄把干细胞注射到视网膜下腔。 这种 微量注射器的应用常见的并发症有：
( 1 )手术者很难与助手协调配合， 微有不慎针头极易穿破视网膜进 入玻璃体腔， 穿破视网膜血管引起视网膜出血， 严重时引起眼内积血， 造成视网膜下腔移植失败， 用微量注射器进行视网膜下腔干细胞移植的 成功率大约在 40〜50%。
( 2 )微量注射器进行视网膜下腔注射时， 不能控制细胞的注射量和 范围， 在注射部位形成移植细胞的小山丘， 细胞的堆积可引起细胞的营 养、 分泌、 代谢、 细胞极性分布的不均衡， 严重的影响视网膜下腔移植 细胞的存活率。
( 3 )由于玻璃微量注射器的设计是针头与注射器为一体，价格昂贵， 注射针头纤细， 常用针头外径为 0. 184〜0. 36mm， 内径为 0. 0826〜 0. 184mm, 注射器的消毒常采用消毒液浸泡法， 高压消毒可以造成注射针 头的锐度下降。
( 4 ) 由于针头内径的纤细， 使用后不易清洗， 溶液浸泡容易引起消 毒不彻底， 可造成手术的污染。
发明内容
为了更好解决上述现有技术中所存在的问题， 本发明提供一种操作 简单、 安全可靠的视网膜下腔干细胞移植器。
为了实现上述发明目的， 本发明采用以下技术方案：
设计一种视网膜下腔干细胞移植器， 包括针头、 套管、 注射动力推 进管、 旋盖， 所述针头、 套管、 注射动力推进管、 旋盖依次安装连接， 该移植器还包括直线电机、 驱动该直线电机的电源、 控制该直线电机启 停的控制开关、 安装于该套管内用于预装干细胞的定量储藏管、 安装于 所述注射动力推进管内的限位固定件， 所述限位固定件内设有导向孔， 所述直线电机的初级安装固定于所述注射动力推进管内， 所述直线电机 的次级一端穿过所述限位固定件的导向孔后固定连接推压件， 所述定量 储藏管一端对应地连通于所述针头， 其另一端置有活塞， 且该活塞对应 于所述推压件， 所述控制开关安装在所述套管上靠近针头的前段区域。
所述储藏管套管对称部位设置有狭长透视窗， 且在该定量储藏管外 管壁的纵轴上设有刻度。
所述控制开关距定量储藏管套管前端 10〜20mm。
所述定量定量储藏管由医用玻璃制成；
所述针头的型号为 28G、 30G、 31G、 32G、 34G中的任一种。
在所述旋盖内设置有对接于所述直线电机次级的弹簧。
所述控制开关为触摸式开关， 分别设有前进、 停止、 后退按键。 所述旋盖上设有条状突起。
驱动所述直线电机的电源为设置于所述旋盖内的内置电源， 或者为 外接电源。
本发明具有积极有益的效果：
1.本发明视网膜下腔干细胞移植器克服了两人操作不协调带来的穿 破视网膜的风险， 创建了简单易行、 操作方便、 不易污染的移植器， 明 显降低了移植难度， 提高了视网膜下腔移植干细胞的效果。
2.本发明中的视网膜下腔干细胞移植器的针头与注射器可以为分体 的、 且针头可以是一次性的， 可以克服高压消毒造成注射针头的锐度下 降， 并且避免因针头内径的纤细， 使用后不易清洗， 溶液浸泡容易引起 消毒不彻底， 从而造成手术的污染的问题。
3.本发明中的视网膜下腔干细胞移植器， 手术者可以自己操作注射 过程， 不需要与助手配合， 避免了配合过程中微有不慎针头极易穿破视 网膜进入玻璃体腔的状况发生， 穿破视网膜血管引起视网膜出血， 严重 时引起眼内积血， 造成视网膜下腔移植失败， 用微量注射器进行视网膜 下腔干细胞移植的成功率大约在 40〜50%，本发明的视网膜下腔干细胞移 植器提高了视网膜下腔干细胞移植的成功率。
附图说明
图 1本发明中的视网膜下腔干细胞移植器的立体图；
图 2本发明中的视网膜下腔干细胞移植器的剖视图。
在图中， 1为针头、 2为定量储藏管、 3为套管、 4为活塞、 5为推压 件、 6为限位固定件、 7为注射动力推进管、 8为直线电机初级、 9为直 线电机次级、 10为旋盖、 11为弹簧、 12为控制开关、 13为导向孔。
具体实施方式
下面结合附图和具体的实施例对本发明作进一歩详细的描述。
实施例 1 : 一种视网膜下腔干细胞移植器， 参见图 1、 图 2， 包括针 头（30G) 1、 内置活塞 4并预装了定量干细胞的储藏管 2、 套装储藏管的 套管 3、 限位固定件 6、 注射动力推进管 7、 旋盖 10， 直线感应电机、 直 线感应电机的控制开关 12， 所述针头 1与储藏管套管 3螺纹连接， 所述 定量干细胞储藏管 2与储藏管套管 3卡接， 所述套管 3与注射动力推进 管 7—端螺纹连接， 所述限位固定件 6固定安装在注射动力推进管 7内 壁， 所述限位固定件 6内设有导向孔 13， 所述直线感应电机的初级 8固 定在注射动力推进管 7上， 所述直线感应电机的次级 9一端穿过限位固 定件 6的导向孔 13， 并在其端头装有推压件 5， 所述旋盖 10与注射动力 推进管 7螺纹连接， 所述控制开关 12安装在套管 3前段。
所述套管 3两侧对称地开设有狭长透视窗， 在储藏管套管 3的外管 壁纵轴上设有刻度。 所述控制开关 12距套管 3前端 15mm， 长 10mm， 宽 4mm
所述定量储藏管 2由医用玻璃制成； 所述旋盖 10置于注射动力推进 管 7—端装有弹簧 11。 所述旋盖 10上设有用于防滑的条状突起。
上述视网膜下腔干细胞移植器的使用方法如下：
使用时， 把装有定量干细胞的储藏管卡装在储藏管套管内， 针头装 在储藏管套管前端， 注射时手指按动开关， 带活塞的直线感应电机次级 推动定量干细胞储藏管的活塞向前运动， 把定量储藏管中的干细胞注入 视网膜下腔， 当使用完毕按复位开关使直线电机中的次级复位。 因为储 藏管套管上设有刻度， 注射者可以关停直线电机来控制注射量。 另外， 定量储藏管也可以根据移植干细胞体积的不同， 制造成不同体积的干细 胞携带储存管， 再根据注射量的大小选择要使用的定量储藏管， 这样可 以控制注射量的精确度。

Claims

权利要求书
1.一种视网膜下腔干细胞移植器， 包括依次安装连接的针头、 套管、 注射动力推进管、 旋盖， 其特征在于： 该移植器还包括直线电机、 驱动 该直线电机的电源、 控制该直线电机启停的控制开关、 安装于该套管的 用于预装干细胞的定量储藏管， 安装于所述注射动力推进管内的限位固 定件， 所述限位固定件上设有导向孔， 所述直线电机的初级安装固定于 所述注射动力推进管内， 所述直线电机的次级一端穿过所述限位固定件 的导向孔后固定推压件， 所述定量储藏管一端对应地连通于所述针头， 其另一端置有活塞， 且该活塞对应于所述推压件， 所述控制开关安装在 所述套管上靠近针头的前段区域。
2.根据权利要求 1中的视网膜下腔干细胞移植器， 其特征在于： 所 述套管两侧对称部位设有狭长透视窗， 且沿该定量储藏管外管壁的纵轴 上设有刻度。
3.根据权利要求 1的视网膜下腔干细胞移植器， 其特征在于： 所述 控制开关距定量储藏管套管前端 10〜20mm。
4.根据权利要求 1中的视网膜下腔干细胞移植器， 其特征在于： 所 述定量储藏管由医用玻璃制成。
5.根据权利要求 1中的视网膜下腔干细胞移植器， 其特征在于： 所 述针头的型号为 28G、 30G、 31G、 32G或 34G。
6.根据权利要求 1中的视网膜下腔干细胞移植器， 其特征在于： 在 所述旋盖内设置有对接于所述直线电机次级的弹簧。
7.根据权利要求 1中的视网膜下腔干细胞移植器， 其特征在于： 所 述旋盖上设有条状突起。
8.根据权利要求 1中的视网膜下腔干细胞移植器， 其特征在于： 所 述控制开关为触摸式开关， 分别设有前进、 停止、 后退按键。
9.根据权利要求 1中的视网膜下腔干细胞移植器， 其特征在于： 在 所述旋盖内设置有驱动所述直线电机的内置电源。
10.根据权利要求 1中的视网膜下腔干细胞移植器， 其特征在于： 所 述电源为外接电源。
PCT/CN2014/083389 2013-08-06 2014-07-31 视网膜下腔干细胞移植器 WO2015018294A1 (zh)

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