CN115337140A - Eye Implant Device Assembly - Google Patents

Abstract

The invention belongs to the field of medical instruments, and discloses an eye implantation instrument assembly, when the eye implantation instrument assembly is used, a pressing part of an eye puncture device is pressed to push a hollow puncture needle forwards to puncture the front closed end of a needle cylinder and enable an injection accommodating area, a peripheral wall needle hole and a front end needle hole to be communicated, after eye injection is injected into an eye apparent or potential tissue gap, a cavity system and a vessel of an eye to expand the eye, an auxiliary guide needle is further connected with an implant guide structure, and then the eye implant can be implanted into the expanded eye tissue gap, cavity system and vessel.

Description

Translated fromChinese

眼部植入器具总成Eye Implant Device Assembly

技术领域technical field

本发明涉及医疗器具技术领域，具体地，涉及一种眼部植入器具总成。The invention relates to the technical field of medical devices, in particular to an eye implant device assembly.

背景技术Background technique

为应对眼部疾病(例如青光眼、脉络膜上腔或结膜下腔疾病等)，一些现有的治疗方法会借助注射器对眼部的显在或潜在组织间隙、腔系、脉管进行注射、探入、扩张或器械植入等操作。但常规注射器在穿刺时需手动把控穿刺深度，并依赖于医护人员的经验去判断针头是否刺进眼内目标区域，且不同患者的眼部结构通常存在差异，不同医护人员的熟练程度不一，故无法有效保证穿刺精准性。此外，在注射过程中，还需持续施加能够推动注射器推杆的压力，此过程通常无法保证注液速度稳定。In order to deal with eye diseases (such as glaucoma, suprachoroidal or subconjunctival space diseases, etc.), some existing treatment methods use syringes to inject, penetrate into the obvious or potential tissue spaces, cavities, and vessels of the eye. , expansion, or device implantation. However, conventional syringes need to manually control the puncture depth when puncturing, and rely on the experience of medical staff to judge whether the needle penetrates into the target area of the eye, and the eye structure of different patients is usually different, and the proficiency of different medical staff varies , so the puncture accuracy cannot be effectively guaranteed. In addition, during the injection process, it is necessary to continue to apply pressure capable of pushing the syringe plunger, which usually cannot guarantee a stable injection rate.

发明内容Contents of the invention

针对现有技术的上述缺陷或不足，本发明提供了一种眼部植入器具总成，可实现对眼部的显在或潜在组织间隙、腔系、脉管的注射、探入、扩张或器械植入，且对穿刺深度和注液量的控制精准、稳定性高。Aiming at the above-mentioned defects or deficiencies of the prior art, the present invention provides an ocular implant device assembly, which can realize the injection, exploration, expansion or The instrument is implanted, and the control of the puncture depth and fluid injection volume is precise and stable.

为实现上述目的，本发明提供了一种眼部植入器具总成，所述眼部植入器具总成包括：To achieve the above object, the present invention provides an ocular implant assembly, which comprises:

眼部穿刺装置，包括针筒、弹性推移组件、中空穿刺针、至少一个注射剂容纳区、眼部注射剂和植入件导向结构，所述弹性推移组件包括按压部以及位于针筒内腔中且能够与所述按压部形成前后弹性连接的可刺破的活动式密封部，所述中空穿刺针固定连接于所述按压部且形成有前端针孔和周壁针孔，所述注射剂容纳区形成在针筒前封闭端、针筒内腔周壁和所述活动式密封部共同围成的针筒内腔区域中，所述眼部注射剂预先储存于所述注射剂容纳区；An ophthalmic puncture device, comprising a needle barrel, an elastic pushing component, a hollow puncture needle, at least one injection containing area, an eye injection and an implant guide structure, the elastic pushing component includes a pressing part and is located in the inner cavity of the syringe and can A pierceable movable sealing part that is elastically connected front and rear to the pressing part, the hollow puncture needle is fixedly connected to the pressing part and formed with a needle hole at the front end and a needle hole on the peripheral wall, and the injection containing area is formed on the needle In the inner cavity area of the syringe enclosed by the front closed end of the barrel, the surrounding wall of the inner cavity of the syringe, and the movable sealing part, the ophthalmic injection is pre-stored in the injection containing area;

辅助导向针，能够与所述植入件导向结构连接；和an auxiliary guide pin connectable to said implant guide structure; and

眼部植入件，能够通过所述辅助导向针的针腔和所述植入件导向结构导入至所述中空穿刺针的针腔内；The eye implant can be introduced into the needle cavity of the hollow puncture needle through the needle cavity of the auxiliary guide needle and the implant guide structure;

其中，所述眼部穿刺装置设置为能够通过按压所述按压部以将所述中空穿刺针向前推动至刺破所述针筒前封闭端，使得所述眼部注射剂能够从经已依次连通的所述注射剂容纳区、所述周壁针孔和所述前端针孔流出至撑大眼部的组织间隙、腔系、脉管，导入至所述中空穿刺针的针腔内的所述眼部植入件能够从所述前端针孔伸出以植入至被撑大后的所述组织间隙、腔系、脉管。Wherein, the eye puncture device is configured to be able to push the hollow puncture needle forward to pierce the front closed end of the syringe by pressing the pressing part, so that the eye injection can be sequentially communicated with each other. The injection containing area, the peripheral wall needle hole and the front needle hole flow out to the tissue space, cavity system, and blood vessels of the enlarged eye, and are introduced into the eye in the needle cavity of the hollow puncture needle. The implant can protrude from the needle hole at the front end so as to be implanted into the enlarged tissue gap, cavity system, and vessel.

可选地，所述眼部植入件呈丝状或管状。Optionally, the ocular implant is in the shape of a wire or a tube.

可选地，所述眼部植入件包括适用于青光眼引流治疗的引流装置。Optionally, the ocular implant includes a drainage device suitable for glaucoma drainage treatment.

可选地，所述引流装置为能够柔性弯折的柔性分流导管。Optionally, the drainage device is a flexible shunt catheter that can be flexibly bent.

可选地，所述眼部植入器具总成设置为能够将所述引流装置的流出端置于脉络膜上腔且将所述引流装置的流入端置于前房。Optionally, the ocular implant assembly is configured to be able to place the outflow end of the drainage device in the suprachoroidal space and place the inflow end of the drainage device in the anterior chamber.

可选地，所述眼部植入器具总成设置为能够将所述引流装置的流出端置于结膜下腔且将所述引流装置的流入端置于前房。Optionally, the ocular implant assembly is configured to be able to place the outflow end of the drainage device in the subconjunctival space and place the inflow end of the drainage device in the anterior chamber.

可选地，所述引流装置设有位于所述引流装置的流入端和流出端之间的引流装置分流口，所述眼部植入器具总成设置为能够将所述引流装置的流入端置于前房且将所述引流装置的流出端置于脉络膜上腔以及将所述引流装置分流口置于巩膜外。Optionally, the drainage device is provided with a diversion port of the drainage device between the inflow end and the outflow end of the drainage device, and the ocular implant assembly is configured to be able to place the inflow end of the drainage device in In the anterior chamber and place the outflow end of the drainage device in the suprachoroidal space and the shunt port of the drainage device in the episclera.

可选地，所述植入件导向结构包括形成在所述活动式密封部上且朝向所述中空穿刺针倾斜延伸的倾斜导向槽，所述辅助导向针能够从针筒后开口端穿入所述针筒内腔中，并穿过所述倾斜导向槽以穿入位于所述活动式密封部前方的所述周壁针孔。Optionally, the implant guide structure includes an inclined guide groove formed on the movable sealing part and extending obliquely toward the hollow puncture needle, and the auxiliary guide needle can pass through the hollow puncture needle from the rear open end of the syringe. and pass through the inclined guide groove to penetrate into the peripheral wall pinhole located in front of the movable sealing part.

可选地，所述倾斜导向槽沿前后方向贯通设置，所述植入件导向结构还包括嵌入所述倾斜导向槽内且可开合的单向活瓣组件或插装于所述倾斜导向槽内的导向槽密封件，所述辅助导向针能够向前撑开所述单向活瓣组件或向前刺破所述导向槽密封件。Optionally, the inclined guide groove is provided through in the front-rear direction, and the implant guide structure further includes a one-way valve assembly embedded in the inclined guide groove and capable of opening or closing or inserted into the inclined guide groove The guide groove seal inside, the auxiliary guide needle can stretch the one-way valve assembly forward or pierce the guide groove seal forward.

可选地，所述倾斜导向槽形成在所述活动式密封部的上表面且为非贯通槽，所述辅助导向针能够向前刺破所述倾斜导向槽。Optionally, the inclined guide groove is formed on the upper surface of the movable sealing part and is a non-penetrating groove, and the auxiliary guide needle can pierce the inclined guide groove forward.

可选地，所述周壁针孔形成为朝向斜后方开口的倾斜孔，在所述辅助导向针穿过所述倾斜导向槽时，所述辅助导向针的前端对准所述倾斜孔。Optionally, the peripheral wall pinhole is formed as an inclined hole opening obliquely rearward, and when the auxiliary guide needle passes through the inclined guide groove, the front end of the auxiliary guide needle is aligned with the inclined hole.

可选地，所述植入件导向结构包括形成在所述中空穿刺针的周壁且朝向斜后方开口的倾斜导向针孔，所述眼部穿刺装置包括使得所述注射剂容纳区、所述周壁针孔和所述前端针孔连通的导流状态，在所述导流状态下，所述倾斜导向针孔位于所述活动式密封部的后方，所述辅助导向针能够从针筒后开口端伸入所述针筒内腔中并穿入所述倾斜导向针孔。Optionally, the implant guide structure includes an inclined guide needle hole formed on the peripheral wall of the hollow puncture needle and opening obliquely rearward, and the ocular puncture device includes such that the injection containing area, the peripheral wall needle The hole is connected to the front-end pinhole. In the flow-guiding state, the inclined guide pinhole is located behind the movable sealing part, and the auxiliary guide pin can extend from the rear open end of the syringe. into the inner cavity of the syringe and penetrate the inclined guide needle hole.

可选地，所述植入件导向结构还包括嵌入所述倾斜导向针孔内且可开合的单向活瓣组件或插装于所述倾斜导向针孔内的针孔密封件，所述辅助导向针能够向前撑开所述单向活瓣组件或向前刺破所述针孔密封件。Optionally, the implant guiding structure further includes a one-way valve assembly embedded in the needle hole of the inclined guide and can be opened and closed, or a needle hole seal inserted in the needle hole of the inclined guide. The auxiliary guide needle is capable of distracting the one-way valve assembly forward or piercing the needle hole seal forward.

可选地，所述植入件导向结构包括形成在所述按压部的后端面中部位置且可刺破的中部导向槽，所述中空穿刺针形成有后端针孔，所述后端针孔与所述中部导向槽沿轴向对位设置，所述辅助导向针能够从针筒后开口端外向前刺破所述中部导向槽并穿入所述后端针孔。Optionally, the implant guide structure includes a pierceable middle guide groove formed in the middle of the rear end surface of the pressing part, and the hollow puncture needle is formed with a rear needle hole, and the rear needle hole The auxiliary guide needle is axially aligned with the middle guide groove, and the auxiliary guide needle can pierce the middle guide groove forward from the rear open end of the syringe and penetrate into the rear needle hole.

在使用本发明的眼部植入器具总成时，先按压眼部穿刺装置的按压部以将中空穿刺针向前推动至刺破针筒前封闭端并使得注射剂容纳区、周壁针孔和前端针孔连通，在向眼部的显在或潜在组织间隙、腔系、脉管注入眼部注射剂以将其撑大后，进一步将辅助导向针与植入件导向结构连接，然后便可将眼部植入件植入撑大后的眼部组织间隙、腔系、脉管中，整个过程对穿刺深度和的控制精准，稳定性高，且有利于实现定量注液。When using the ocular implant assembly of the present invention, firstly press the pressing part of the ocular puncture device to push the hollow puncture needle forward to puncture the front closed end of the syringe and make the injection containing area, the peripheral wall needle hole and the front end The needle hole is connected. After the ocular injection is injected into the apparent or potential tissue gap, cavity system, and vessel of the eye to expand it, the auxiliary guide needle is further connected with the implant guide structure, and then the eye can be placed. The internal implants are implanted in the expanded ocular tissue gaps, cavities, and vessels. The whole process has precise control over the puncture depth and height, high stability, and is conducive to quantitative injection.

本发明的其它特征和优点将在随后的具体实施方式部分予以详细说明。Other features and advantages of the present invention will be described in detail in the detailed description that follows.

附图说明Description of drawings

附图是用来提供对本发明的进一步理解，并且构成说明书的一部分，与下面的具体实施方式一起用于解释本发明，但并不构成对本发明的限制。在附图中：The accompanying drawings are used to provide a further understanding of the present invention, and constitute a part of the description, together with the following specific embodiments, are used to explain the present invention, but do not constitute a limitation to the present invention. In the attached picture:

图1至图5为本发明的具体实施方式中的一种医用穿刺装置在动物的组织间隙、腔系、脉管穿刺和注液过程中的不同状态下的示意图；1 to 5 are schematic diagrams of a medical puncture device in a specific embodiment of the present invention in different states during animal tissue space, cavity system, vessel puncture and liquid injection;

图6至图10为本发明的具体实施方式中的另一种医用穿刺装置在动物的组织间隙、腔系、脉管穿刺和注液过程中的不同状态下的示意图；6 to 10 are schematic diagrams of another medical puncture device in different states during animal tissue space, cavity system, vessel puncture and liquid injection in the specific embodiment of the present invention;

图11至图13为本发明的具体实施方式中的一种设有多个注射剂容纳区的医用穿刺装置在不同状态下的局部结构示意图；Figures 11 to 13 are partial structural schematic diagrams of a medical puncture device provided with multiple injection containing areas in different states according to the specific embodiment of the present invention;

图14至图16为本发明的具体实施方式中的另一种设有多个注射剂容纳区的医用穿刺装置在不同状态下的局部结构示意图；14 to 16 are partial structural schematic diagrams of another medical puncture device provided with multiple injection containing areas in different states according to the specific embodiment of the present invention;

图17为本发明的具体实施方式中设有贯通的倾斜导向槽和单向活瓣组件的医用穿刺装置的局部结构示意图；Fig. 17 is a partial structural schematic diagram of a medical puncture device provided with a through inclined guide groove and a one-way valve assembly in a specific embodiment of the present invention;

图18为采用图17中的医用穿刺装置的医疗器具总成的局部结构示意图；Fig. 18 is a partial structural schematic diagram of a medical appliance assembly using the medical puncture device in Fig. 17;

图19为本发明的具体实施方式中设有非贯通的倾斜导向槽的医用穿刺装置的局部结构示意图；Fig. 19 is a partial structural schematic diagram of a medical puncture device provided with a non-penetrating inclined guide groove in a specific embodiment of the present invention;

图20为本发明的具体实施方式中设有倾斜导向针孔和单向活瓣组件的医用穿刺装置的局部结构示意图；Fig. 20 is a partial structural schematic diagram of a medical puncture device provided with an oblique guide pinhole and a one-way valve assembly in a specific embodiment of the present invention;

图21为本发明的具体实施方式中设有倾斜导向针孔和针孔密封件的医用穿刺装置的局部结构示意图；Fig. 21 is a partial structural schematic diagram of a medical puncture device provided with inclined guide pinholes and pinhole seals in a specific embodiment of the present invention;

图22为利用本发明的具体实施方式中设有中部导向槽的医疗器具总成向动物的组织间隙、腔系、脉管置入植入件时的示意图；Fig. 22 is a schematic diagram of using the medical device assembly provided with the guide groove in the middle part of the specific embodiment of the present invention to insert the implant into the tissue space, cavity system and blood vessel of the animal;

图23至图29为本发明的具体实施方式中的一种用于将引流装置植入眼内的方法；Fig. 23 to Fig. 29 are a method for implanting a drainage device into an eye in a specific embodiment of the present invention;

图30至图36为本发明的具体实施方式中的另一种用于将引流装置植入眼内的方法，该方法需切开结膜；Fig. 30 to Fig. 36 are another method for implanting the drainage device in the eye according to the specific embodiment of the present invention, the method needs to cut the conjunctiva;

图37至图42为本发明的具体实施方式中的另一种用于将引流装置植入眼内的方法，该方法无须切开结膜；Fig. 37 to Fig. 42 are another method for implanting the drainage device in the eye according to the specific embodiment of the present invention, the method does not need to cut the conjunctiva;

图43至图45为本发明的具体实施方式中的一种采用本发明的医用穿刺装置(或医疗器具总成)以将引流装置从内路植入眼内的方法中的注射步骤示意图；43 to 45 are schematic diagrams of the injection steps in a method of using the medical puncture device (or medical device assembly) of the present invention to implant the drainage device into the eye from the internal route in the specific embodiment of the present invention;

图46至图49为本发明的具体实施方式中的另一种医用穿刺装置在动物的组织间隙、腔系、脉管穿刺和注液过程中的不同状态下的示意图。Fig. 46 to Fig. 49 are schematic diagrams of another medical puncture device in different states in the process of puncturing tissue spaces, cavities, vessels, and injecting fluid in an animal according to the specific embodiment of the present invention.

附图标记说明：Explanation of reference signs:

1 针筒 2 按压部1Barrel 2 Push part

3 活动式密封部 4 弹性护套3Movable seal 4 Elastomeric sheath

5(5’) 弹簧 6 中空穿刺针5(5’)Spring 6 Hollow Piercing Needle

7 注射剂容纳区 8 前端密封件7Syringe containment area 8 Front seal

9 单向活瓣组件 10 针孔密封件9Check valve assembly 10 Needle hole seal

11 植入件 12 辅助导向针11Implant 12 Auxiliary Guide Pin

13 隔离密封部 14 结膜13Isolation seal 14 Conjunctiva

15 结膜下腔 16 巩膜15Subconjunctival space 16 Sclera

17 脉络膜 18 脉络膜上腔17Choroid 18 Suprachoroidal space

19 角膜 20 前房19cornea 20 anterior chamber

21 加压控制滑块21 Pressurization Control Slider

1a 轴向限位部 2c 中部导向槽1a Axial stopper 2c Middle guide groove

3a 倾斜导向槽 6a 前端针孔3aInclined guide groove 6a Front needle hole

6b 周壁针孔 6c 倾斜导向针孔6b Circumferential pinhole 6c Inclined guide pinhole

7a 前注射剂容纳区 7b 后注射剂容纳区7aFront injection container 7b Rear injection container

6b1 前周壁针孔 6b2 后周壁针孔6b1 Anterior peripheral wall pinhole 6b2 Posterior peripheral wall pinhole

具体实施方式Detailed ways

以下结合附图对本发明实施例的具体实施方式进行详细说明。应当理解的是，此处所描述的具体实施方式仅用于说明和解释本发明实施例，并不用于限制本发明实施例。The specific implementation manners of the embodiments of the present invention will be described in detail below in conjunction with the accompanying drawings. It should be understood that the specific implementation manners described here are only used to illustrate and explain the embodiments of the present invention, and are not intended to limit the embodiments of the present invention.

需要说明的是，在不冲突的情况下，本发明中的实施例及实施例中的特征可以相互组合。It should be noted that, in the case of no conflict, the embodiments of the present invention and the features in the embodiments can be combined with each other.

在本发明实施例中，使用的方位词“前、后、向前、向后、前端、后端”等均是基于使用本发明的医用穿刺装置或医疗器具总成的操作人员(例如，外科医生、医师、护士、技术人员等)的视角而定，即，在操作人员使用医用穿刺装置或医疗器具总成时，相对远离操作人员的方向为向前方向，相对靠近操作人员的方向为向后方向。In the embodiments of the present invention, the orientation words "front, rear, forward, backward, front end, rear end" etc. used are all based on the operator (for example, surgical staff) using the medical puncture device or medical instrument assembly of the present invention. Doctors, physicians, nurses, technicians, etc.), that is, when the operator uses the medical puncture device or medical device assembly, the direction relatively far away from the operator is the forward direction, and the direction relatively close to the operator is the forward direction. rear direction.

下面将参考附图并结合示例性实施例来详细说明本发明。The present invention will be described in detail below in conjunction with exemplary embodiments with reference to the accompanying drawings.

如图1至图22所示，本发明第一示例性实施例提供了一种医用穿刺装置，其包括针筒1、弹性推移组件、中空穿刺针6以及至少一个注射剂容纳区7。As shown in FIGS. 1 to 22 , the first exemplary embodiment of the present invention provides a medical puncture device, which includes asyringe 1 , an elastic pushing assembly, ahollow puncture needle 6 and at least oneinjection containing area 7 .

其中，针筒1包括针筒前封闭端和针筒后开口端，在产品化时，可将针筒1设计成沿轴向两端开口的结构，通过在针筒1的前端开口处设置前端密封件8以实现密封，该前端密封件8需采用橡胶等可被中空穿刺针6刺破的材质。Wherein, thesyringe 1 includes a front closed end of the syringe and a rear open end of the syringe. When commercialized, thesyringe 1 can be designed as a structure with openings at both ends in the axial direction. The sealingmember 8 is used to realize the sealing, and the front sealingmember 8 needs to adopt materials such as rubber that can be pierced by thehollow puncture needle 6 .

弹性推移组件包括按压部2和活动式密封部3，活动式密封部3位于针筒内腔中且能够沿轴向移动，按压部2通常至少部分伸出针筒后开口端外以供操作人员手动按压，通过对按压部2施加压力，活动式密封部3与按压部2能够形成前后弹性连接，此时若保持住按压部2的位置不变，活动式密封部3在与按压部2之间的回弹力作用下具有向前移动的趋势。The elastic push assembly includes apressing part 2 and amovable sealing part 3. Themovable sealing part 3 is located in the inner cavity of the syringe and can move in the axial direction. Thepressing part 2 usually extends at least partially out of the rear open end of the syringe for the operator Manual pressing, by applying pressure to thepressing part 2, themovable sealing part 3 and thepressing part 2 can form an elastic connection back and forth. It has a tendency to move forward under the action of the rebound force between them.

此外，按压部2还可包括伸入针筒内腔的部分，且该部分可与针筒内腔周壁和活动式密封部3共同限定出密闭区，即，活动式密封部3的后方可形成有密闭区，该密闭区内可容纳有流动或不流动的介质，例如消毒气体等。或者，按压部2伸入针筒内腔的部分还可与针筒内腔周壁和活动式密封部3共同限定出非密闭区，即，活动式密封部3的后方可形成有非密闭区，用于连接外部环境。In addition, thepressing part 2 may also include a part protruding into the inner cavity of the syringe, and this part may jointly define a closed area with the peripheral wall of the inner cavity of the syringe and themovable sealing part 3, that is, the rear of themovable sealing part 3 may be formed. There is a closed area in which flowing or non-flowing media, such as sterilizing gases, etc. can be contained. Alternatively, the part of thepressing part 2 extending into the inner cavity of the syringe can also define a non-airtight area together with the peripheral wall of the inner cavity of the syringe and themovable sealing part 3, that is, a non-airtight area can be formed behind themovable sealing part 3, Used to connect to the external environment.

中空穿刺针6则固定连接于按压部2，在未对按压部2施加压力的情况下，中空穿刺针6不会向前移动而刺破针筒前封闭端，但也不限制在产品出厂时中空穿刺针6已是刺破针筒前封闭端的状态。而对于中空穿刺针6本身，其形成有前端针孔6a和周壁针孔6b，前端针孔6a与周壁针孔6b通过中空穿刺针6的针腔连通。Thehollow puncture needle 6 is fixedly connected to thepressing part 2. When no pressure is applied to thepressing part 2, thehollow puncture needle 6 will not move forward and pierce the front closed end of the syringe, but it is not limited to when the product leaves the factory. Thehollow puncture needle 6 is in the state of puncturing the front closed end of the syringe. As for thehollow puncture needle 6 itself, afront needle hole 6 a and a peripheralwall needle hole 6 b are formed, and thefront needle hole 6 a communicates with the peripheralwall needle hole 6 b through the needle cavity of thehollow puncture needle 6 .

注射剂容纳区7用于储存注射剂。其中，注射剂包括但不限于液体、溶液、悬浮液、凝胶、油、软膏、乳剂、乳膏、泡沫、洗剂、糊剂等，可分别单独储存在注射剂容纳区7内，也能以混合物的形式储存。注射剂优选采用易于操纵的液体(例如溶液、悬浮液等)或半固体组合物(例如凝胶)，最好能够在注入并撑大组织间隙、腔系、脉管后定型。例如，可以在目标部位处或附近进行注射，注射剂随即凝结定型，可具有更高的强度以保持撑大组织间隙、腔系、脉管。Theinjection containing area 7 is used for storing injections. Among them, injections include but are not limited to liquids, solutions, suspensions, gels, oils, ointments, emulsions, creams, foams, lotions, pastes, etc., which can be stored separately in theinjection containing area 7, or in a mixture stored in the form. Injections are preferably liquids (such as solutions, suspensions, etc.) or semisolid compositions (such as gels) that are easy to handle, and can be shaped after injection and expansion of tissue spaces, lumens, and vessels. For example, the injection can be made at or near the target site, and the injection can then coagulate and set, and can have higher strength to maintain and expand tissue spaces, lumens, and vessels.

注射剂可具有流动性，包括具有低粘度、高粘度或者类似于水的粘度的制剂，例如糊状材料。制剂的流动性可使其符合组织部位的不规则、缝隙、裂缝和/或空隙。例如，该制剂可用于填充一个或多个空隙，扩大组织空隙(例如，显在组织空隙)和/或使潜在的组织空隙形成为显在的组织空隙，以及任选地扩大所产生的空隙。此外，在与水性介质(例如体液、水等)接触时，一些注射剂还可硬化以形成便于控制药物释放的药物仓库。Injections may have fluidity, including preparations having low viscosity, high viscosity, or a viscosity similar to water, such as pasty materials. The fluidity of the formulation allows it to conform to irregularities, crevices, cracks and/or voids of the tissue site. For example, the formulation can be used to fill one or more voids, enlarge tissue voids (e.g., apparent tissue voids) and/or cause potential tissue voids to become apparent tissue voids, and optionally enlarge the resulting voids. In addition, some injectable formulations can harden upon contact with an aqueous medium (eg, body fluids, water, etc.) to form a drug depot that facilitates controlled drug release.

注射剂容纳区7形成在针筒前封闭端、针筒内腔周壁和活动式密封部3共同围成的针筒内腔区域中。由于活动式密封部3在注射过程中可沿轴向移动，使得注射剂容纳区7具有可变容积，从而使注射剂容纳区7内的注射剂压力能够随活动式密封部3的轴向移动而产生变化。The injectionaccommodating area 7 is formed in the inner cavity area of the syringe surrounded by the front closed end of the syringe, the surrounding wall of the inner cavity of the syringe and themovable sealing part 3 . Since themovable sealing part 3 can move axially during the injection process, theinjection containing area 7 has a variable volume, so that the pressure of the injection in theinjection containing area 7 can change with the axial movement of themovable sealing part 3 .

在利用本示例性实施例的医用穿刺装置穿刺时，通过对按压部2施加压力，中空穿刺针6能够被向前推动至刺破针筒前封闭端，当中空穿刺针6刺入显在或潜在组织间隙、腔系、脉管且周壁针孔6b位于注射剂容纳区7内时，注射剂容纳区7、周壁针孔6b和前端针孔6a连通。通过合理设计，可使注射剂容纳区7内的注射剂压力大于显在或潜在组织间隙、腔系、脉管内的压力，在存在压力差的情况下，注射剂便可依次通过周壁针孔6b和前端针孔6a流入显在或潜在组织间隙、腔系、脉管。When using the medical puncture device of this exemplary embodiment to puncture, by applying pressure to thepressing part 2, thehollow puncture needle 6 can be pushed forward to puncture the front closed end of the needle barrel, and thehollow puncture needle 6 can pierce into the obvious or When potential tissue gaps, cavities, vessels, and the peripheralwall needle hole 6b are located in theinjection containing area 7, theinjection containing area 7, the peripheralwall needle hole 6b and thefront needle hole 6a are in communication. Through reasonable design, the pressure of the injection in theinjection accommodation area 7 can be greater than the pressure in the apparent or potential tissue gap, cavity system, and vessel. In the case of a pressure difference, the injection can pass through the peripheralwall needle hole 6b and the front needle in turn.Holes 6a flow into apparent or potential tissue spaces, lumens, vessels.

在上述注射过程中，由于活动式密封部3与按压部2保持前后弹性连接，因此只需保持按住按压部2，无须进一步增大按压力，在活动式密封部3与按压部2之间的回弹力作用下，就能使注射剂持续向周壁针孔6b内流动，实现对显在或潜在组织间隙、腔系、脉管的注射、探入、扩张。During the above-mentioned injection process, since themovable sealing part 3 and thepressing part 2 are elastically connected front and rear, it is only necessary to keep pressing thepressing part 2, and there is no need to further increase the pressing force. Under the action of the rebound force, the injection can continue to flow into the peripheralwall needle hole 6b, so as to realize the injection, penetration and expansion of the obvious or potential tissue gaps, cavities and vessels.

在中空穿刺针6刺入显在或潜在组织间隙、腔系、脉管之前，前端针孔6a处所受到的外部压力大于注射剂容纳区7内的注射剂压力，故注射剂无法从前端针孔6a流出。比如，以对眼部脉络膜上腔的穿刺过程为例进行解释，在中空穿刺针6刺破巩膜但尚未刺入脉络膜上腔时，不论周壁针孔6b是否与注射剂容纳区7连通，注射剂都不会从前端针孔6a流出，这是由于巩膜较为致密，当前端针孔6a位于巩膜内时，相当于在前端针孔6a处形成较大的外部压力，该外部压力大于注射剂容纳区7内的注射剂压力，使注射剂无法向外流出。Before thehollow puncture needle 6 penetrates into the apparent or potential tissue gap, lumen, or vessel, the external pressure on thefront needle hole 6a is greater than the injection pressure in theinjection containing area 7, so the injection cannot flow out from thefront needle hole 6a. For example, taking the puncture process of the suprachoroidal space of the eye as an example to explain, when thehollow puncture needle 6 pierces the sclera but has not penetrated into the suprachoroidal space, no matter whether the peripheralwall needle hole 6b communicates with theinjection accommodating area 7, the injection will not It will flow out from thefront needle hole 6a, because the sclera is relatively dense. When thefront needle hole 6a is located in the sclera, it is equivalent to forming a relatively large external pressure at thefront needle hole 6a, which is greater than the pressure in theinjection accommodation area 7. The injection pressure prevents the injection from flowing out.

因此，通过观察活动式密封部3是否在与按压部2之间的回弹力作用下向前移动，便可判断中空穿刺针6是否已经刺入显在或潜在组织间隙、腔系、脉管内，从而提醒操作人员当前的穿刺深度，保证对穿刺深度的精准控制。而由于通过注射剂容纳区7内的注射剂压力变化控制注液，注液过程无须人为再增大所施加的推力，可防止注射忽缓忽急，保证注液稳定。Therefore, by observing whether themovable sealing part 3 moves forward under the action of the elastic force between thepressing part 2, it can be judged whether thehollow puncture needle 6 has pierced into the apparent or potential tissue gap, cavity system, or vessel. Thereby reminding the operator of the current puncture depth and ensuring precise control of the puncture depth. And because the injection is controlled by the pressure change of the injection in theinjection containing area 7, the injection process does not need to artificially increase the applied thrust, which can prevent the injection from being slow and hasty, and ensure the stability of the injection.

在一些实施例中，医用穿刺装置还包括设置在活动式密封部3和针筒前封闭端之间的针筒内腔区域中且能够沿轴向滑移的可刺破的至少一个隔离密封部13。在此结构下，注射剂容纳区7形成有多个，且多个注射剂容纳区7在隔离密封部13的作用下沿轴向依次隔离布置。其中，多个注射剂容纳区7均可储存相同的注射剂，也可储存不同的注射剂。In some embodiments, the medical puncture device further includes at least one pierceable isolation sealing part arranged in the inner cavity region of the syringe between themovable sealing part 3 and the front closed end of the syringe and capable of sliding in theaxial direction 13. Under this structure, a plurality ofinjection accommodating areas 7 are formed, and the plurality ofinjection accommodating areas 7 are arranged in isolation along the axial direction under the function of theisolation sealing part 13 . Wherein, multipleinjection containing areas 7 can store the same injection, and can also store different injections.

例如，参照图11至图16，注射剂容纳区7包括前后隔离的前注射剂容纳区7a和后注射剂容纳区7b。For example, referring to FIG. 11 to FIG. 16 , theinjection containing area 7 includes a frontinjection containing area 7 a and a rearinjection containing area 7 b separated front and rear.

在图11至图13所示的实施例中，周壁针孔6b包括前后间隔设置的前周壁针孔和后周壁针孔。在此结构下，若先使中空穿刺针6穿刺至使得前周壁针孔连通前注射剂容纳区7a且后周壁针孔被隔离密封部13包围密封，前注射剂容纳区7a内的注射剂便会先依次通过前周壁针孔和前端针孔6a流入显在或潜在组织间隙、腔系、脉管，在活动式密封部3与按压部2之间的回弹力作用下，前注射剂容纳区7a内的注射剂量不断减少，活动式密封部3和隔离密封部13不断向前移动。通过合理的设计，可在隔离密封部13堵住前周壁针孔之前，使得后周壁针孔与后注射剂容纳区7b连通，从而使后注射剂容纳区7b内的注射剂依次通过后周壁针孔和前端针孔6a流入显在或潜在组织间隙、腔系、脉管。因此在本实施例中，可实现将前注射剂容纳区7a和后注射剂容纳区7b内的注射剂按顺序注入显在或潜在组织间隙、腔系、脉管。In the embodiment shown in FIG. 11 to FIG. 13 , theperipheral wall pinholes 6 b include front peripheral wall pinholes and rear peripheral wall pinholes which are spaced apart from each other. Under this structure, if thehollow puncture needle 6 is first punctured until the needle hole of the front peripheral wall communicates with the frontinjection containing area 7a and the needle hole of the rear peripheral wall is surrounded and sealed by theisolation sealing part 13, the injections in the frontinjection containing area 7a will firstly Through the needle hole of the front peripheral wall and theneedle hole 6a of the front end, it flows into the apparent or potential tissue gap, cavity system, and blood vessel. The dose is continuously reduced, and themovable seal 3 and theisolation seal 13 are continuously moved forward. Through reasonable design, before theisolation sealing part 13 blocks the needle hole of the front peripheral wall, the needle hole of the rear peripheral wall can be connected with the rearinjection containing area 7b, so that the injection in the rearinjection containing area 7b can pass through the needle hole of the rear peripheral wall and the front end in turn. Thepinhole 6a flows into an apparent or potential tissue space, cavity system, vessel. Therefore, in this embodiment, injections in the frontinjection accommodating area 7a and the rearinjection accommodating area 7b can be sequentially injected into apparent or potential tissue spaces, lumens, and vessels.

在图11至图13所示的另一实施例中，也可使中空穿刺针6穿刺至使得前周壁针孔连通前注射剂容纳区7a且后周壁针孔连通后注射剂容纳区7b，从而能够将前注射剂容纳区7a和后注射剂容纳区7b内的注射剂混合后再注入显在或潜在组织间隙、腔系、脉管。In another embodiment shown in Fig. 11 to Fig. 13, thehollow puncture needle 6 can also be pierced to make the needle hole of the front peripheral wall communicate with the frontinjection containing area 7a and the needle hole of the rear peripheral wall communicate with the rearinjection containing area 7b, so that the The injections in the frontinjection accommodating area 7a and the rearinjection accommodating area 7b are mixed and then injected into apparent or potential tissue spaces, cavity systems, and vessels.

在图14至图16所示的实施例中，周壁针孔6b只设置一个，通过合理设计，可将中空穿刺针6穿刺至使得周壁针孔6b的前部与前注射剂容纳区7a连通且周壁针孔6b的后部被隔离密封部13包围密封。此时，前注射剂容纳区7a内的注射剂便会先依次通过周壁针孔6b的前部和前端针孔6a流入显在或潜在组织间隙、腔系、脉管，在活动式密封部3与按压部2之间的回弹力作用下，前注射剂容纳区7a内的注射剂量不断减少，活动式密封部3和隔离密封部13不断向前移动。同样通过合理的设计，可在隔离密封部13堵住前周壁针孔的前部之前，使得周壁针孔6b的后部与后注射剂容纳区7b连通，从而使后注射剂容纳区7b内的注射剂依次通过周壁针孔6b的后部和前端针孔6a流入显在或潜在组织间隙、腔系、脉管。因此在本实施例中，也可实现将前注射剂容纳区7a和后注射剂容纳区7b内的注射剂按顺序注入显在或潜在组织间隙、腔系、脉管。In the embodiment shown in Fig. 14 to Fig. 16, only one peripheralwall needle hole 6b is provided, and through rational design, thehollow puncture needle 6 can be pierced so that the front part of the peripheralwall needle hole 6b communicates with the frontinjection containing area 7a and the peripheral wall The rear portion of thepinhole 6 b is surrounded and sealed by theisolation seal portion 13 . At this time, the injection in the frontinjection containing area 7a will first pass through the front part of the peripheralwall needle hole 6b and thefront needle hole 6a to flow into the obvious or potential tissue gap, cavity system, blood vessel, and then press themovable sealing part 3 Under the action of the resilience between theparts 2, the injection dose in the frontinjection containing area 7a is continuously reduced, and themovable sealing part 3 and theisolation sealing part 13 are constantly moving forward. Also through a reasonable design, before theisolation sealing part 13 blocks the front part of the front peripheral wall needle hole, the rear part of the peripheralwall needle hole 6b is communicated with therear injection container 7b, so that the injections in therear injection container 7b are successively Through the rear part of the peripheralwall needle hole 6b and thefront needle hole 6a, it flows into the apparent or potential tissue space, cavity system, and vessel. Therefore, in this embodiment, injections in the frontinjection accommodating area 7a and the rearinjection accommodating area 7b can also be injected into apparent or potential tissue spaces, lumens, and vessels in sequence.

在图14至图16所示的另一实施例中，也可将中空穿刺针6穿刺至使得周壁针孔6b的前部与前注射剂容纳区7a连通、周壁针孔6b的后部与后注射剂容纳区7b连通且周壁针孔6b的前部和后部之间的部分被隔离密封部13包围密封，从而能够将前注射剂容纳区7a和后注射剂容纳区7b内的注射剂混合后再注入显在或潜在组织间隙、腔系、脉管。In another embodiment shown in Fig. 14 to Fig. 16, thehollow puncture needle 6 can also be pierced so that the front part of the peripheralwall needle hole 6b communicates with the frontinjection containing area 7a, and the rear part of the peripheralwall needle hole 6b communicates with the rear injection agent. Theaccommodating area 7b is connected, and the part between the front and the rear of the peripheralwall needle hole 6b is surrounded and sealed by theisolation sealing part 13, so that the injection in the frontinjection accommodating area 7a and the rearinjection accommodating area 7b can be mixed and then injected Or potential tissue spaces, lumens, vessels.

需要说明的是，本文中述及的显在或潜在组织间隙、腔系、脉管可以是脉络膜上腔、硬膜外腔、胸膜腔、腹膜腔、关节腔、动脉、静脉等，不作具体限制，因此本示例性实施例的医用穿刺装置还具有通用性强的优点。It should be noted that the apparent or potential tissue spaces, cavities, and vessels mentioned in this article may be suprachoroidal space, epidural space, pleural cavity, peritoneal cavity, articular cavity, artery, vein, etc., without specific limitations , so the medical puncture device of this exemplary embodiment also has the advantage of high versatility.

在本示例性实施例的医用穿刺装置出厂后且被使用前，中空穿刺针6的具体位置可略有不同，即，医用穿刺装置可被设置成多种出厂形态。After the medical puncture device of this exemplary embodiment leaves the factory and before it is used, the specific position of thehollow puncture needle 6 may be slightly different, that is, the medical puncture device can be set in various factory configurations.

例如，中空穿刺针6已刺破活动式密封部3但未刺破针筒前封闭端。此时，周壁针孔6b可位于活动式密封部3的后方、被活动式密封部3包围密封或者与注射剂容纳区7连通，前端针孔6a可连通注射剂容纳区7或被针筒前封闭端包围密封。For example, thehollow puncture needle 6 has pierced themovable sealing part 3 but not the front closed end of the syringe. At this time, the peripheralwall needle hole 6b can be located behind themovable sealing part 3, surrounded and sealed by themovable sealing part 3 or communicated with theinjection containing area 7, and thefront needle hole 6a can communicate with theinjection containing area 7 or be closed by the front end of the syringe Surrounded by seal.

或者，中空穿刺针6已刺破活动式密封部3和针筒前封闭端。此时，周壁针孔6b可位于活动式密封部3的后方、被活动式密封部3包围密封或者与注射剂容纳区7连通，前端针孔6a位于针筒前封闭端外。Or, thehollow puncture needle 6 has pierced themovable sealing part 3 and the front closed end of the syringe. At this time, the peripheralwall needle hole 6b can be located behind themovable sealing part 3, surrounded and sealed by themovable sealing part 3 or communicated with theinjection containing area 7, and thefront needle hole 6a is located outside the front closed end of the syringe.

又或者，中空穿刺针6未刺破活动式密封部3，即整体位于活动式密封部3的后方。相应地，周壁针孔6b和前端针孔6a均位于活动式密封部3的后方。Alternatively, thehollow puncture needle 6 does not puncture themovable sealing part 3 , that is, the whole is located behind themovable sealing part 3 . Correspondingly, both theperipheral wall pinhole 6 b and the front end pinhole 6 a are located behind themovable sealing part 3 .

可见，只要在产品出厂时保证周壁针孔6b与注射剂容纳区7互不连通，那么无论中空穿刺针6是否刺破活动式密封部3和针筒前封闭端，前端针孔6a是否位于针筒前封闭端外，均可杜绝注射剂在穿刺前从前端针孔6a外泄的可能。It can be seen that as long as theperipheral wall pinhole 6b and theinjection containing area 7 are not connected to each other when the product leaves the factory, no matter whether thehollow puncture needle 6 pierces themovable sealing part 3 and the front closed end of the syringe, whether thefront pinhole 6a is located in the syringe Outside the front closed end, the possibility of the injection being leaked from thefront needle hole 6a before puncturing can be prevented.

实际上，由前述可知，若通过合理设计而使得前端针孔6a在连通显在或潜在组织间隙、腔系、脉管之前受到的外部压力大于注射剂容纳区7内的注射剂压力，那么即使在产品出厂时周壁针孔6b与注射剂容纳区7连通，也不会出现注射剂从前端针孔6a提前外泄的情况。In fact, it can be seen from the foregoing that if thefront needle hole 6a is subjected to an external pressure greater than the injection pressure in theinjection accommodation area 7 before communicating with the apparent or potential tissue gap, cavity system, and vessel through reasonable design, then even if the product The peripheralwall needle hole 6b communicates with theinjection containing area 7 when leaving the factory, and the injection will not leak out from thefront needle hole 6a in advance.

此外，针对由于周壁针孔6b位于活动式密封部3的后方且前端针孔6a位于注射剂容纳区7时可能出现的注射剂倒流的情况，后文将有相应的实施例作为补救措施，故此处暂不具体说明。In addition, for the possible reverse flow of the injection when the peripheralwall needle hole 6b is located behind themovable sealing part 3 and thefront needle hole 6a is located in theinjection containing area 7, there will be corresponding embodiments as remedial measures later on, so here Do not specify.

在不同的产品形态中，较为优选的一种是产品出厂时中空穿刺针6未刺破活动式密封部3，即中空穿刺针6整体位于活动式密封部3的后方。在使用具有此出厂形态的医用穿刺装置进行穿刺时，可通过按压按压部2以驱动中空穿刺针6向前依次刺破活动式密封部3和针筒前封闭端，直至前端针孔6a进入显在或潜在组织间隙、腔系、脉管且周壁针孔6b与注射剂容纳区7连通。Among the different product forms, the more preferable one is that thehollow puncture needle 6 does not puncture themovable sealing part 3 when the product leaves the factory, that is, thehollow puncture needle 6 is located behind themovable sealing part 3 as a whole. When using the medical puncture device in this factory form for puncture, thehollow puncture needle 6 can be driven forward by pressing thepressing part 2 to pierce themovable sealing part 3 and the front closed end of the syringe in sequence until thefront needle hole 6a enters the display. In or potential tissue spaces, lumens, vessels, and peripheral wall needle holes 6 b communicate with theinjection containing area 7 .

为保证中空穿刺针6最终能够刺破针筒前封闭端，可在活动式密封部3的后端面设置用于引导中空穿刺针6穿刺的导槽、导向盲孔或导向狭缝等穿刺导向结构。In order to ensure that thehollow puncture needle 6 can finally puncture the front closed end of the syringe, the rear end surface of themovable sealing part 3 can be provided with guide grooves, guide blind holes or guide slits and other puncture guide structures for guiding thehollow puncture needle 6 to puncture. .

在中空穿刺针6刺破针筒前封闭端之后，医用穿刺装置至少包括两个不同的状态，即表层组织穿刺状态和导流状态。After thehollow puncture needle 6 punctures the front closed end of the syringe, the medical puncture device includes at least two different states, ie, the superficial tissue puncture state and the flow diversion state.

在表层组织穿刺状态下，中空穿刺针6从针筒前封闭端伸出的长度范围为表层组织穿刺长度范围，在此范围内，中空穿刺针6的前端刺入至表层组织内但尚未刺入至显在或潜在组织间隙、腔系、脉管，由于表层组织较为致密，此时前端针孔6a处所受到的外部压力大于注射剂容纳区7内的注射剂压力，因此不论周壁针孔6b是否与注射剂容纳区7连通，注射剂都无法向外流出。In the superficial tissue puncture state, the length range of thehollow puncture needle 6 protruding from the front closed end of the syringe is the superficial tissue puncture length range, and within this range, the front end of thehollow puncture needle 6 penetrates into the superficial tissue but has not yet penetrated As for the apparent or potential tissue gaps, cavities, and blood vessels, since the surface tissue is relatively dense, the external pressure on thefront pinhole 6a is greater than the pressure of the injection in theinjection accommodation area 7, so regardless of whether the peripheralwall needle hole 6b is in contact with the injection Theaccommodation area 7 is connected, and the injection cannot flow out.

而在导流状态下，中空穿刺针6从针筒前封闭端伸出的长度范围为导流长度范围，在此范围内，中空穿刺针6已刺入至显在或潜在组织间隙、腔系、脉管。如前所述，可通过合理设计，保证注射剂容纳区7内的注射剂压力大于显在或潜在组织间隙、腔系、脉管内的压力。当周壁针孔6b与注射剂容纳区7连通时，在存在内外压力差的情况下，注射剂容纳区7内的注射剂便能依次通过周壁针孔6b和前端针孔6a流入显在或潜在组织间隙、腔系、脉管。In the diversion state, the length range of thehollow puncture needle 6 protruding from the front closed end of the syringe is the diversion length range. , Vessels. As mentioned above, reasonable design can ensure that the pressure of the injection in theinjection accommodation area 7 is greater than the pressure in the apparent or potential tissue space, cavity system, and vessel. When the peripheralwall needle hole 6b communicates with theinjection accommodating area 7, the injection in theinjection accommodating area 7 can flow through the peripheralwall needle hole 6b and the frontend needle hole 6a into the apparent or potential tissue space, Cavities, vessels.

下面分别描述控制医用穿刺装置注液动作停止的多种可选实施例。Various optional embodiments for controlling the stop of the liquid injection action of the medical puncture device are described below.

在一种实施例中，当医用穿刺装置处于导流状态时，活动式密封部3能够在与按压部2之间的回弹力作用下向前移动至封堵周壁针孔6b，在周壁针孔6b被封堵后，注液动作随即停止。由此可见，周壁针孔6b在注射剂容纳区8内的轴向位置限定了医用穿刺装置的最大注液量。In one embodiment, when the medical puncture device is in the diversion state, themovable sealing part 3 can move forward to block theperipheral wall pinhole 6b under the action of the elastic force between thepressing part 2 and theperipheral wall pinhole 6b. After 6b is blocked, the liquid injection action stops immediately. It can be seen that the axial position of the peripheralwall needle hole 6b in theinjection accommodating area 8 limits the maximum injection volume of the medical puncture device.

例如，当需要将注射剂容纳区7排空时，可限定活动式密封部3在向前移动至抵接针筒前封闭端时封堵周壁针孔6b，故此时周壁针孔6b位于注射剂容纳区7的前端部。但实际上，随着注射剂容纳区7内的注射剂逐渐流入显在或潜在组织间隙、腔系、脉管，会存在注射剂容纳区7内的注射剂压力与显在或潜在组织间隙、腔系、脉管内的压力相同的状态，此时活动式密封部3由于受力平衡而不再移动。若要将注射剂容纳区7排空，还需增大施加在活动式密封部3上的向前推力。For example, when theinjection containing area 7 needs to be emptied, themovable sealing part 3 can be restricted to block the peripheralwall needle hole 6b when it moves forward to abut against the front closed end of the syringe, so the peripheralwall needle hole 6b is located in the injection containing area at this time. 7 at the front end. But in fact, as the injection in theinjection accommodation area 7 gradually flows into the apparent or potential tissue spaces, cavities, and vessels, there will be pressure of the injection in theinjection accommodation area 7 and the apparent or potential tissue spaces, cavities, and vessels. In the state where the pressure in the tube is the same, themovable sealing part 3 will no longer move due to force balance. If theinjection containing area 7 is to be emptied, the forward thrust applied to themovable sealing part 3 also needs to be increased.

例如参照图6至图10所示的实施例，可在针筒1的周壁设置沿轴向延伸的滑槽(未示出)，并在按压部2上设置匹配于该滑槽的滑块(即按压部2中伸出针筒1外的部分)，使按压部2的按压移动行程上限更大，当活动式密封部3由于受力平衡而不再移动时，可施加更大的按压力在按压部2的滑块上，驱动按压部2继续向前移动，使活动式密封部3与按压部2之间的回弹力增大，打破活动式密封部3的受力平衡状态，使活动式密封部3继续向前移动，如此，注射剂容纳区7便可排出更多的流体，甚至排空。For example, with reference to the embodiments shown in FIGS. 6 to 10 , an axially extending chute (not shown) can be set on the peripheral wall of thesyringe 1, and a slide block matching the chute ( That is, the part of thepressing part 2 protruding out of the syringe 1), so that the upper limit of the pressing movement stroke of thepressing part 2 is larger, and when themovable sealing part 3 no longer moves due to force balance, a greater pressing force can be applied On the slider of thepressing part 2, the drivingpressing part 2 continues to move forward, so that the rebound force between themovable sealing part 3 and thepressing part 2 is increased, breaking the force balance state of themovable sealing part 3, and making the movable Thetype sealing part 3 continues to move forward, so that theinjection containing area 7 can discharge more fluid, or even be emptied.

或者，也可借助其他驱动结构将活动式密封部3进一步推移至抵接针筒前封闭端，一种可选的驱动结构将在以下实施例中述及。Alternatively, themovable sealing part 3 may be further pushed to abut against the front closed end of the syringe by means of other driving structures, and an optional driving structure will be described in the following embodiments.

在另一种实施例中，医用穿刺装置包括手动控制部，该手动控制部与活动式密封部3连接且部分伸出针筒外。例如，活动式密封部3可与手动控制部形成前后弹性连接，或者，手动控制部也可直接与活动式密封部3固定连接，但显然，在形成弹性连接的情况下，更利于保持稳定的注液速度。In another embodiment, the medical puncture device includes a manual control part, which is connected with themovable sealing part 3 and partially protrudes out of the syringe. For example, themovable sealing part 3 can be elastically connected back and forth with the manual control part, or the manual control part can also be directly fixedly connected with themovable sealing part 3, but obviously, in the case of forming an elastic connection, it is more conducive to maintaining a stable Injection speed.

当注入显在或潜在组织间隙、腔系、脉管内的注射剂量未达到原定目标，且活动式密封部3又由于受力平衡不再移动时，操作人员可通过控制手动控制部中伸出针筒外的部分以驱动活动式密封部3继续向前移动，直至外排的注射剂量达到原定目标为止。采用本实施例中的方案，便可解决上一实施例中不能将注射剂容纳区7排空的问题。当然，本实施例不局限应用在要将注射剂容纳区7排空的情况。When the injection dose injected into the apparent or potential tissue gaps, lumens, and blood vessels does not reach the original target, and themovable sealing part 3 is no longer moving due to force balance, the operator can control the manual control part to protrude. The part outside the syringe continues to move forward by driving themovable sealing part 3 until the injection dose discharged out reaches the original target. The solution in this embodiment can solve the problem that theinjection containing area 7 cannot be emptied in the previous embodiment. Of course, this embodiment is not limited to the situation where theinjection containing area 7 is to be emptied.

参照图46至图49，可在针筒1位于活动式密封部3后方的周壁部分设置沿轴向延伸的针筒周壁滑槽，此时手动控制部包括与针筒周壁滑槽滑移配合的加压控制滑块21，该加压控制滑块21通过针筒周壁滑槽部分伸出针筒1外，便于用户操控，并且活动式密封部3与加压控制滑块21形成前后弹性连接，例如在活动式密封部3与加压控制滑块21之间设置如图所示的弹簧5’。在此结构下，通过在加压控制滑块21上进一步施加压力以使其沿针筒周壁滑槽轴向向前滑移，可使活动式密封部3和加压控制滑块21之间弹性压缩，当保持住加压控制滑块的位置时，在回弹力的作用下，活动式密封部3便可打破受力平衡状态而继续向前移动，直至外排的注射剂量达到原定目标为止。Referring to Fig. 46 to Fig. 49, a syringe peripheral wall chute extending in the axial direction can be provided on the peripheral wall part of thesyringe 1 located behind themovable sealing part 3, and at this time, the manual control part includes a Thepressurization control slider 21 protrudes out of thesyringe 1 through the chute on the peripheral wall of the syringe, which is convenient for the user to manipulate, and themovable sealing part 3 and thepressurization control slider 21 form a front and back elastic connection, For example, aspring 5 ′ as shown in the figure is provided between themovable sealing part 3 and thepressurization control slider 21 . Under this structure, by applying further pressure on thepressure control slider 21 to make it slide axially forward along the slide groove on the peripheral wall of the syringe, the elastic gap between themovable sealing part 3 and thepressure control slider 21 can be made. Compression, when the position of the pressurization control slider is maintained, under the action of the rebound force, themovable sealing part 3 can break the state of force balance and continue to move forward until the amount of injection discharged reaches the original target .

在另一种实施例中，医用穿刺装置可实现注射剂定量注射。具体地，参照图1至图10，在针筒内腔中设置位于活动式密封部3前方且用于限位活动式密封部3向前移动的轴向限位部1a，当医用穿刺装置处于导流状态时，周壁针孔6b位于轴向限位部1a的前方，活动式密封部3能够在与按压部2之间的回弹力作用下向前移动。In another embodiment, the medical puncture device can achieve quantitative injection of injections. Specifically, referring to Fig. 1 to Fig. 10, an axial stopper 1a located in front of themovable seal part 3 and used to limit the forward movement of themovable seal part 3 is provided in the inner cavity of the syringe. In the flow-guiding state, theperipheral wall pinhole 6b is located in front of the axial limiting portion 1a, and themovable sealing portion 3 can move forward under the elastic force between thepressing portion 2 and thepressing portion 2 .

要实现活动式密封部3移动至被轴向限位部1a限位，分为两种情况：In order to realize the movement of themovable sealing part 3 to be limited by the axial limit part 1a, there are two cases:

第一种情况是直到活动式密封部3移动至被轴向限位部1a限位，注射剂容纳区7内的注射剂压力仍不小于显在或潜在组织间隙、腔系、脉管内的压力，换言之，此时仅凭借活动式密封部3与按压部2之间的回弹力，便可将活动式密封部3向前推动至被轴向限位部1a限位，而无须再借助其他驱动结构。The first situation is that until themovable sealing part 3 moves to be limited by the axial limit part 1a, the pressure of the injection in theinjection containing area 7 is still not less than the pressure in the apparent or potential tissue gap, cavity system, and vessel, in other words At this time, themovable sealing part 3 can be pushed forward to be limited by the axial limit part 1a only by virtue of the rebound force between themovable sealing part 3 and thepressing part 2, without resorting to other driving structures.

第二种情况是活动式密封部3在与按压部2之间的回弹力作用下被推动至与轴向限位部1a抵接之前，注射剂容纳区7内的注射剂压力便已与显在或潜在组织间隙、腔系、脉管内的压力相同(即活动式密封部3由于受力平衡而不再移动)，此时仅凭借活动式密封部3与按压部2之间的回弹力，是无法将活动式密封部3推动至被轴向限位部1a限位的，因此便需通过额外设置的驱动结构进一步向前推动活动式密封部3，例如，该驱动结构可以是前述的手动控制部。但无论属于哪种情况，本实施例中设置的轴向限位部1a是实现注射剂定量注射的基础。The second situation is that before themovable sealing part 3 is pushed to abut against the axial limit part 1a under the action of the resilience between thepressing part 2, the pressure of the injection in theinjection containing area 7 has already reached the apparent or The pressure in the potential tissue gap, the cavity system, and the blood vessel is the same (that is, themovable sealing part 3 no longer moves due to the force balance), at this time, only relying on the resilience between themovable sealing part 3 and thepressing part 2, it is impossible to Push themovable sealing part 3 to be limited by the axial limit part 1a, so it is necessary to further push themovable sealing part 3 forward through an additional driving structure, for example, the driving structure can be the aforementioned manual control part . However, no matter what the situation is, the axial limiting part 1a provided in this embodiment is the basis for realizing the quantitative injection of the injection.

下面分别描述医用穿刺装置的多种不同的穿刺、注液时机。Various puncture and liquid injection timings of the medical puncture device are described below.

在一种实施例中，在中空穿刺针6从针筒前封闭端伸出之前，周壁针孔6b始终保持在注射剂容纳区7的上方，如此设置，可杜绝出现前端针孔6a处提前漏液的现象，提高医用穿刺装置的可靠性。In one embodiment, before thehollow puncture needle 6 protrudes from the front closed end of the syringe, the peripheralwall needle hole 6b is always kept above theinjection containing area 7, so that the premature leakage of thefront needle hole 6a can be prevented. Phenomenon, improve the reliability of medical puncture device.

在另一种实施例中，当医用穿刺装置处于表层组织穿刺状态时，即，在中空穿刺针6从针筒前封闭端伸出的长度处于表层组织穿刺长度范围内时(或者说是在中空穿刺针6的前端刺入至表层组织内但尚未刺入至显在或潜在组织间隙、腔系、脉管时)，周壁针孔6b至少部分连通注射剂容纳区7。换言之，在中空穿刺针6的前端刺入至显在或潜在组织间隙、腔系、脉管之前，提前使得注射剂容纳区7、周壁针孔6b和前端针孔6a连通，从而使注射剂提前注入中空穿刺针6的针腔内，至少排走一部分空气，减小进入显在或潜在组织间隙、腔系、脉管内的空气量。In another embodiment, when the medical puncture device is in the superficial tissue puncturing state, that is, when the length of thehollow puncture needle 6 protruding from the front closed end of the syringe is within the superficial tissue puncturing length range (or in the hollow When the front end of thepuncture needle 6 penetrates into the superficial tissue but has not yet penetrated into the apparent or potential tissue gap, cavity system, or vessel), the peripheralwall needle hole 6 b at least partially communicates with theinjection containing area 7 . In other words, before the front end of thehollow puncture needle 6 penetrates into the apparent or potential tissue gap, cavity system, or vessel, theinjection containing area 7, the peripheralwall needle hole 6b and thefront needle hole 6a are communicated in advance, so that the injection agent is injected into the hollow space in advance. In the needle cavity of thepuncture needle 6, at least part of the air is exhausted to reduce the amount of air entering the obvious or potential tissue gaps, cavities, and vessels.

更优选地，当中空穿刺针6的前端开始刺入表层组织内的同时，周壁针孔6b便开始连通注射剂容纳区7，那么当中空穿刺针6的前端刺入至显在或潜在组织间隙、腔系、脉管时，中空穿刺针6的针腔内便早已注满注射剂，完全杜绝空气进入显在或潜在组织间隙、腔系、脉管的可能。More preferably, when the front end of thehollow puncture needle 6 starts to penetrate into the superficial tissue, the peripheralwall needle hole 6b begins to communicate with theinjection containing area 7, then the front end of thehollow puncture needle 6 penetrates into the apparent or potential tissue gap, During cavity system, blood vessel, just filled injection in the needle chamber ofhollow puncture needle 6 already, stopped the possibility of air entering obvious or potential tissue space, cavity system, blood vessel completely.

在另一种实施例中，当医用穿刺装置处于导流状态时，即，在中空穿刺针6从针筒前封闭端伸出的长度处于导流长度范围内时(或者说是在中空穿刺针6的前端刺入至显在或潜在组织间隙、腔系、脉管时)，周壁针孔6b已完全位于注射剂容纳区7内，使得周壁针孔6b的流量最大，提升注液速度。In another embodiment, when the medical puncture device is in the diversion state, that is, when the length of thehollow puncture needle 6 protruding from the front closed end of the syringe is within the range of the diversion length (or in other words, the hollow puncture needle When the front end of 6 penetrates into the obvious or potential tissue gap, cavity system, and blood vessel), the peripheralwall needle hole 6b is completely located in theinjection containing area 7, so that the flow rate of the peripheralwall needle hole 6b is the largest, and the injection speed is improved.

以上三个实施例既可单独实施，也可组合实施。The above three embodiments can be implemented independently or in combination.

下面描述一种可防止流体倒流而从周壁针孔6b反向溢出的实施例。An embodiment that prevents the fluid from flowing backward and overflowing from theperipheral wall pinhole 6b will be described below.

当前端针孔6a与注射剂容纳区7连通而周壁针孔6b仍位于活动式密封部3的后方时，或当前端针孔6a位于显在或潜在组织间隙、腔系、脉管内而周壁针孔6b仍位于活动式密封部3的后方时，存在注射剂倒流而从周壁针孔6b反向溢出的风险。为此，可在弹性推移组件中设置外套于中空穿刺针6的弹性护套4，当周壁针孔6b位于活动式密封部3的后方时(即周壁针孔6b未与注射剂容纳区7连通时)，该弹性护套4可保持封堵周壁针孔6b，从而有效避免注射剂倒流溢出，防止污染活动式密封部3的后方区域，减少流体损耗，提高产品可靠性。When the front-end needle hole 6a communicates with theinjection containing area 7 and the peripheralwall needle hole 6b is still located behind themovable sealing part 3, or the front-end needle hole 6a is located in an apparent or potential tissue space, cavity system, or vessel and the peripheral wall needle hole When 6b is still located behind themovable sealing part 3, there is a risk that the injection will flow back and overflow from the peripheralwall needle hole 6b. For this reason, theelastic sheath 4 covering thehollow puncture needle 6 can be set in the elastic pushing assembly. ), theelastic sheath 4 can keep blocking theperipheral wall pinhole 6b, so as to effectively prevent the injection from flowing back and overflowing, prevent the rear area of themovable sealing part 3 from being polluted, reduce fluid loss, and improve product reliability.

实际上，弹性护套4即使未被用于封堵周壁针孔6b，也可仅作为活动式密封部3与按压部2之间的弹性连接部件使用。具体地，通过向前按压按压部2，可使活动式密封部3与按压部2之间的弹性护套4受到挤压，从而在活动式密封部3与按压部2之间形成回弹力，驱动活动式密封部3向前移动。此外，活动式密封部3与按压部2之间的弹性连接部件还可以是轴向两端分别连接活动式密封部3和按压部2的弹簧5。弹簧5和弹性护套4既可单独设置，也可组合使用。In fact, even if theelastic sheath 4 is not used to block theperipheral wall pinhole 6 b, it can only be used as an elastic connection part between themovable sealing part 3 and thepressing part 2 . Specifically, by pressing thepressing part 2 forward, theelastic sheath 4 between themovable sealing part 3 and thepressing part 2 can be squeezed, thereby forming a resilient force between themovable sealing part 3 and thepressing part 2, Themovable sealing part 3 is driven to move forward. In addition, the elastic connecting member between themovable sealing part 3 and thepressing part 2 can also be aspring 5 whose axial ends are respectively connected to themovable sealing part 3 and thepressing part 2 . Thespring 5 and theelastic sheath 4 can be arranged separately or in combination.

要在活动式密封部3与按压部2之间形成弹性连接，也可通过除设置弹性连接部件以外的其他方式实现。例如，可将活动式密封部3与按压部2设置为一体成型的弹性部件。To form an elastic connection between themovable sealing part 3 and thepressing part 2, it can also be realized in other ways than providing elastic connecting parts. For example, themovable sealing part 3 and thepressing part 2 may be provided as integrally formed elastic components.

下面分别描述能够通过医用穿刺装置向显在或潜在组织间隙、腔系、脉管内植入医疗器械的多种不同的实施例，为便于理解，植入的医疗器械以丝状或管状的植入件11为例，当然，植入件11还可以是针状植入件、电极、传感器等。A variety of different embodiments in which medical devices can be implanted into apparent or potential tissue spaces, cavities, and vessels through medical puncture devices are described below. Theimplant 11 is taken as an example, and of course, theimplant 11 may also be a needle implant, an electrode, a sensor, and the like.

具体地，医用穿刺装置中设有用于将植入件11导入中空穿刺针6的针腔内的植入件导向结构。Specifically, the medical puncture device is provided with an implant guide structure for guiding theimplant 11 into the needle cavity of thehollow puncture needle 6 .

在一种实施例中，参照图17至图19，植入件导向结构包括形成在活动式密封部3上且朝向中空穿刺针6倾斜延伸的倾斜导向槽3a。当注射剂容纳区7、周壁针孔6b和前端针孔6a连通时，先待注射剂将显在或潜在组织间隙、腔系、脉管扩张，然后使植入件11通过倾斜导向槽3a、周壁针孔6b、中空穿刺针6的针腔和前端针孔6a植入扩张后的显在或潜在组织间隙、腔系、脉管内。In one embodiment, referring to FIGS. 17 to 19 , the implant guiding structure includes aninclined guiding groove 3 a formed on themovable sealing part 3 and extending obliquely toward thehollow puncture needle 6 . When theinjection containing area 7, the peripheralwall needle hole 6b and the frontend needle hole 6a are in communication, the injection will first expand the apparent or potential tissue space, cavity system, and blood vessels, and then theimplant 11 will pass through theinclined guide groove 3a, the peripheral wall needle Thehole 6b, the needle lumen of thehollow puncture needle 6 and theneedle hole 6a at the front end are implanted into the expanded apparent or potential tissue gaps, lumens, and blood vessels.

需要说明的是，倾斜导向槽3a既可是沿前后方向贯通的贯通槽，也可是形成在活动式密封部3的上表面的非贯通槽。It should be noted that theinclined guide groove 3 a may be a through groove penetrating in the front-rear direction, or may be a non-penetrating groove formed on the upper surface of themovable seal part 3 .

当倾斜导向槽3a为贯通槽时，植入件导向结构还可包括嵌入倾斜导向槽3a内且可开合的单向活瓣组件9，该单向活瓣组件9在未受到外力时处于常闭状态，避免注射剂容纳区7内的注射剂从此处泄漏，但在受到张开力时，其多块活瓣可被撑开，使植入件11能够从撑开口穿入至周壁针孔6b。或者，植入件导向结构也可包括插装于倾斜导向槽3a内的导向槽密封件，当需要植入植入件11时，先将导向槽密封件拔出即可。When theinclined guide groove 3a is a through groove, the implant guiding structure may also include a one-way valve assembly 9 embedded in theinclined guide groove 3a and capable of opening and closing. The closed state prevents the injection in theinjection containing area 7 from leaking there, but when subjected to the opening force, its multiple flaps can be stretched, so that theimplant 11 can pass through the stretch opening to the peripheralwall needle hole 6b. Alternatively, the guide structure of the implant may also include a guide groove seal inserted into theinclined guide groove 3a, and when theimplant 11 needs to be implanted, the guide groove seal may be pulled out first.

当倾斜导向槽3a为非贯通槽时，可通过植入件11直接将其刺破，或采用其他刺破件刺破后，再使植入件11穿过刺破口以穿入周壁针孔6b。When theinclined guide groove 3a is a non-through groove, it can be punctured directly by theimplant 11, or pierced by other piercing members, and then theimplant 11 is passed through the puncture opening to penetrate the needle hole of theperipheral wall 6b.

在本实施例中，为匹配于倾斜导向槽3a的导向，可将周壁针孔6b设置为朝向斜后方开口的倾斜孔，使周壁针孔6b能够与倾斜导向槽3a对准，以精准导入植入件11。In this embodiment, in order to match the guidance of theinclined guide groove 3a, theperipheral wall pinhole 6b can be set as an inclined hole opening obliquely rearward, so that theperipheral wall pinhole 6b can be aligned with theinclined guide groove 3a, so as to accurately introduce the implant.Entry 11.

在另一种实施例中，参照图20和图21，植入件导向结构包括形成在中空穿刺针6的周壁且朝向斜后方开口的倾斜导向针孔6c，在医用穿刺装置的导流状态下，倾斜导向针孔6c也始终保持在活动式密封部3的后方，植入件11可通过该倾斜导向针孔6c穿入中空穿刺针6的针腔内，并通过前端针孔6a植入至扩张后的显在或潜在组织间隙、腔系、脉管。In another embodiment, referring to Fig. 20 and Fig. 21, the implant guide structure includes an obliqueguide needle hole 6c formed on the peripheral wall of thehollow puncture needle 6 and opening obliquely rearward. , the obliqueguide needle hole 6c is also always kept behind themovable sealing part 3, theimplant 11 can pass through the obliqueguide needle hole 6c into the needle cavity of thehollow puncture needle 6, and be implanted into the Dilated apparent or potential tissue spaces, lumens, vessels.

类似于上一实施例，植入件导向结构还可包括嵌入倾斜导向针孔6c内且可开合的单向活瓣组件9或插装于倾斜导向针孔6c内的针孔密封件10，先通过撑开单向活瓣组件9或拔出针孔密封件10，便可进行植入件11的植入操作。Similar to the previous embodiment, the implant guide structure can also include a one-way valve assembly 9 embedded in the inclinedguide needle hole 6c and can be opened and closed, or aneedle hole seal 10 inserted in the inclinedguide needle hole 6c, The implantation operation of theimplant 11 can be performed by stretching the one-way valve assembly 9 or pulling out thepinhole sealing member 10 first.

在另一种实施例中，参照图22，植入件导向结构包括形成在按压部2的后端面中部位置且可刺破的中部导向槽2c，中空穿刺针6形成有后端针孔，并且该后端针孔与中部导向槽2c沿轴向对位设置。在需要植入植入件11时，可先刺破中部导向槽2c，然后将植入件11通过中部导向槽2c的刺破口和中空穿刺针6的后端针孔穿入至中空穿刺针6的针腔内，然后便可通过前端针孔6a进一步植入至扩张后的显在或潜在组织间隙、腔系、脉管内。In another embodiment, referring to FIG. 22, the implant guide structure includes a pierceablemiddle guide groove 2c formed in the middle of the rear end surface of thepressing part 2, thehollow puncture needle 6 is formed with a rear end needle hole, and The rear needle hole is axially aligned with thecentral guide groove 2c. When theimplant 11 needs to be implanted, themiddle guide groove 2c can be punctured first, and then theimplant 11 can be inserted into the hollow puncture needle through the puncture opening of themiddle guide groove 2c and the rear end needle hole of thehollow puncture needle 6. 6, and then through thefront needle hole 6a, it can be further implanted into the expanded obvious or potential tissue gaps, lumens, and blood vessels.

下面描述若干种医用穿刺装置形成为拼装式结构的实施例。Several kinds of medical puncturing devices are described below in an assembled structure.

在一种实施例中，医用穿刺装置包括相互独立加工成型的穿刺控制模块和流体存储模块。其中，穿刺控制模块包括第一针筒单元以及设置在第一针筒单元的筒腔内的弹性推移组件和中空穿刺针6，结合前述的不同实施例可知，穿刺控制模块还可包括弹性护套4、弹簧5等部件。而流体存储模块包括第二针筒单元、形成在第二针筒单元的筒腔内的注射剂容纳区7以及可拆卸地封装在第二针筒单元后端的模块封装件。第一针筒单元与第二针筒单元之间形成有可拆卸连接结构，第一针筒单元与第二针筒单元相互拼接后便形成为针筒1。结合前述的不同实施例可知，流体存储模块还可包括前端密封件8等部件。In one embodiment, the medical puncture device includes a puncture control module and a fluid storage module that are independently processed and formed. Wherein, the puncture control module includes a first syringe unit, an elastic pushing assembly and ahollow puncture needle 6 arranged in the cavity of the first syringe unit, and it can be seen from the different embodiments described above that the puncture control module may also include anelastic sheath 4.Spring 5 and other components. The fluid storage module includes a second syringe unit, an injectionaccommodating area 7 formed in the barrel cavity of the second syringe unit, and a module package detachably packaged at the rear end of the second syringe unit. A detachable connection structure is formed between the first syringe unit and the second syringe unit, and thesyringe 1 is formed after the first syringe unit and the second syringe unit are spliced together. It can be seen from the different embodiments described above that the fluid storage module may also include components such as thefront seal 8 .

可见，穿刺控制模块和流体存储模块可分别产品化，再拼装成医用穿刺装置。模块封装件用于将注射剂容纳区7的后端密封，当穿刺控制模块和流体存储模块拼装时，可将模块封装件拆卸。It can be seen that the puncture control module and the fluid storage module can be commercialized separately, and then assembled into a medical puncture device. The module package is used to seal the rear end of theinjection containing area 7, and the module package can be disassembled when the puncture control module and the fluid storage module are assembled.

在另一种实施例中，医用穿刺装置包括相互独立加工成型的穿刺控制模块和流体存储模块。其中，穿刺控制模块包括第一针筒单元以及设置在第一针筒单元的筒腔内的按压部2和中空穿刺针6，结合前述的不同实施例可知，穿刺控制模块还可包括弹性护套4、弹簧5等部件。而流体存储模块包括第二针筒单元、形成在第二针筒单元的筒腔内的注射剂容纳区7以及封装在第二针筒单元后端的活动式密封部3，此时活动式密封部3用于密封注射剂容纳区7的后端。第一针筒单元与第二针筒单元之间形成有可拆卸连接结构，第一针筒单元与第二针筒单元相互拼接后便形成为针筒1，且活动式密封部3与按压部2形成前后弹性连接。结合前述的不同实施例可知，流体存储模块还可包括前端密封件8等部件。In another embodiment, the medical puncture device includes a puncture control module and a fluid storage module that are independently processed and formed. Wherein, the puncture control module includes the first syringe unit, thepressing part 2 and thehollow puncture needle 6 arranged in the cylinder cavity of the first syringe unit, and it can be seen from the different embodiments mentioned above that the puncture control module may also include anelastic sheath 4.Spring 5 and other components. The fluid storage module includes a second syringe unit, aninjection containing area 7 formed in the cavity of the second syringe unit, and amovable sealing part 3 packaged at the rear end of the second syringe unit. At this time, themovable sealing part 3 Used to seal the rear end of theinjection containing area 7. A detachable connection structure is formed between the first syringe unit and the second syringe unit. After the first syringe unit and the second syringe unit are spliced together, thesyringe 1 is formed, and themovable sealing part 3 and thepressing part 2 Form the front and rear elastic connections. It can be seen from the different embodiments described above that the fluid storage module may also include components such as thefront seal 8 .

在另一种实施例中，医用穿刺装置包括相互独立加工成型的穿刺控制模块、过渡连接模块和流体存储模块。其中，穿刺控制模块包括第一针筒单元以及设置在第一针筒单元的筒腔内的按压部2和中空穿刺针6，结合前述的不同实施例可知，穿刺控制模块还可包括弹性护套4、弹簧5等部件。过渡连接模块包括第二针筒单元以及设置在第二针筒单元的筒腔内的活动式密封部3。流体存储模块包括第三针筒单元、形成在第三针筒单元的筒腔内的注射剂容纳区7以及可拆卸地封装在第三针筒单元后端的模块封装件。第一针筒单元、第二针筒单元和第三针筒单元依次可拆卸连接，第一针筒单元、第二针筒单元、第三针筒单元依次拼接后便形成为针筒1，且活动式密封部3与按压部2形成前后弹性连接。结合前述的不同实施例可知，流体存储模块还可包括前端密封件8等部件。In another embodiment, the medical puncture device includes a puncture control module, a transition connection module, and a fluid storage module that are independently processed and formed. Wherein, the puncture control module includes the first syringe unit, thepressing part 2 and thehollow puncture needle 6 arranged in the cylinder cavity of the first syringe unit, and it can be seen from the different embodiments mentioned above that the puncture control module may also include anelastic sheath 4.Spring 5 and other components. The transition connection module includes a second syringe unit and amovable sealing part 3 arranged in the cylinder chamber of the second syringe unit. The fluid storage module includes a third syringe unit, aninjection containing area 7 formed in the barrel cavity of the third syringe unit, and a module package detachably packaged at the rear end of the third syringe unit. The first syringe unit, the second syringe unit, and the third syringe unit are detachably connected in sequence, and the first syringe unit, the second syringe unit, and the third syringe unit are sequentially spliced to form asyringe 1, and Themovable sealing part 3 and thepressing part 2 are elastically connected front and rear. It can be seen from the different embodiments described above that the fluid storage module may also include components such as thefront seal 8 .

本发明第二示例性实施例提供了一种医疗器具总成，参照图18和图22，其包括植入件11和上述设有植入件导向结构的医用穿刺装置，因此能够通过医用穿刺装置向动物的显在或潜在组织间隙、腔系、脉管(包括但不限于脉络膜上腔、硬膜外腔、胸膜腔、腹膜腔、关节腔、动脉、静脉)内植入植入件11。此外，本示例性实施例中的医疗器具总成显然具备由上述医用穿刺装置带来的所有技术效果，故此处不再重复赘述。The second exemplary embodiment of the present invention provides a medical device assembly, referring to Fig. 18 and Fig. 22, which includes animplant 11 and the above-mentioned medical puncture device provided with an implant guiding structure, so that the medical puncture device can Theimplant 11 is implanted into the apparent or potential tissue spaces, cavities, vessels (including but not limited to suprachoroidal space, epidural space, pleural cavity, peritoneal cavity, joint cavity, artery, vein) of the animal. In addition, the medical device assembly in this exemplary embodiment obviously possesses all the technical effects brought about by the above-mentioned medical puncturing device, so it will not be repeated here.

在一种实施例中，医疗器具总成还包括匹配于植入件导向结构使用且中空的辅助导向针12，辅助导向针12的针腔口径大小足以供植入件11穿入。在进行植入件11植入操作时，先将辅助导向针12与植入件导向结构连接，植入件11便能依次通过辅助导向针12的针腔和植入件导向结构以被导入至中空穿刺针6的针腔内，继而通过前端针孔6a植入显在或潜在组织间隙、腔系、脉管。In one embodiment, the medical device assembly further includes a hollowauxiliary guide needle 12 that is matched with the implant guide structure, and the diameter of the needle lumen of theauxiliary guide needle 12 is sufficient for theimplant 11 to penetrate. When theimplant 11 is implanted, theauxiliary guide needle 12 is first connected to the implant guide structure, and theimplant 11 can pass through the needle cavity of theauxiliary guide needle 12 and the implant guide structure to be introduced into the In the needle cavity of thehollow puncture needle 6, theneedle hole 6a at the front end is then implanted into the apparent or potential tissue gap, cavity system, and vessel.

例如，参照图18，植入件导向结构包括贯通的倾斜导向槽3a和嵌入倾斜导向槽3a内且可开合的单向活瓣组件9，周壁针孔6b设置为朝向斜后方开口的倾斜孔。在植入植入件11时，先利用辅助导向针12撑开单向活瓣组件9以穿设在倾斜导向槽3a中，且辅助导向针12的前端穿入周壁针孔6b，然后使植入件11依次通过辅助导向针12的针腔、中空穿刺针6的针腔和前端针孔6a植入显在或潜在组织间隙、腔系、脉管。For example, referring to FIG. 18 , the implant guide structure includes a penetratinginclined guide groove 3 a and a one-way valve assembly 9 embedded in theinclined guide groove 3 a that can be opened and closed, and the peripheralwall needle hole 6 b is set as an inclined hole that opens obliquely backward. . When theimplant 11 is implanted, theauxiliary guide needle 12 is used to expand the one-way valve assembly 9 to pass through theinclined guide groove 3a, and the front end of theauxiliary guide needle 12 penetrates the peripheralwall needle hole 6b, and then theimplant Insertion part 11 is implanted into apparent or potential tissue gaps, cavity systems, and vessels through the needle lumen ofauxiliary guide needle 12, the needle lumen ofhollow puncture needle 6, and thefront needle hole 6a in sequence.

在另一种实施例中，植入件导向结构包括沿前后方向贯通设置的倾斜导向槽3a和插装于倾斜导向槽3a内的导向槽密封件，辅助导向针12能够向前刺破导向槽密封件且前端穿入周壁针孔6b，从而连通中空穿刺针6的针腔。In another embodiment, the implant guide structure includes aninclined guide groove 3a penetratingly arranged along the front-rear direction and a guide groove seal inserted in theinclined guide groove 3a, and theauxiliary guide needle 12 can pierce the guide groove forward. The sealing member and the front end penetrate into the peripheralwall needle hole 6 b, thereby communicating with the needle chamber of thehollow puncture needle 6 .

在另一种实施例中，倾斜导向槽3a形成在活动式密封部3的上表面且为非贯通槽，辅助导向针12能够向前刺破倾斜导向槽3a且前端穿入周壁针孔6b，从而连通中空穿刺针6的针腔。In another embodiment, theinclined guide groove 3a is formed on the upper surface of themovable sealing part 3 and is a non-penetrating groove, theauxiliary guide pin 12 can pierce theinclined guide groove 3a forward and the front end penetrates the peripheralwall needle hole 6b, Thereby, the needle cavity of thehollow puncture needle 6 is communicated.

上述实施例中的周壁针孔6b可形成为朝向斜后方开口的倾斜孔，使得在辅助导向针12穿过倾斜导向槽3a时，辅助导向针12的前端能够对准倾斜孔。Theneedle hole 6b on the peripheral wall in the above embodiment can be formed as an inclined hole opening obliquely rearward, so that when theauxiliary guide needle 12 passes through theinclined guide groove 3a, the front end of theauxiliary guide needle 12 can be aligned with the inclined hole.

在另一种实施例中，植入件导向结构包括形成在中空穿刺针6的周壁且朝向斜后方开口的倾斜导向针孔6c，在医用穿刺装置的导流状态下，倾斜导向针孔6c位于活动式密封部3的后方，辅助导向针12能够从针筒后开口端伸入针筒内腔中并穿入倾斜导向针孔6c，从而连通中空穿刺针6的针腔。In another embodiment, the implant guide structure includes an obliqueguide needle hole 6c formed on the peripheral wall of thehollow puncture needle 6 and opening obliquely rearward. Behind themovable sealing part 3 , theauxiliary guide needle 12 can extend into the inner cavity of the syringe from the rear open end of the syringe and penetrate into the inclinedguide needle hole 6c, thereby communicating with the needle cavity of thehollow puncture needle 6 .

进一步地，植入件导向结构还可包括嵌入倾斜导向针孔6c内且可开合的单向活瓣组件9或插装于倾斜导向针孔6c内的针孔密封件10，使得辅助导向针12能够向前撑开单向活瓣组件9或向前刺破针孔密封件10，从而连通中空穿刺针6的针腔。Further, the implant guide structure can also include a one-way valve assembly 9 embedded in the inclinedguide needle hole 6c and can be opened and closed, or aneedle hole seal 10 inserted in the inclinedguide needle hole 6c, so that theauxiliary guide needle 12 can stretch the one-way valve assembly 9 forward or pierce theneedle hole seal 10 forward, so as to communicate with the needle cavity of thehollow puncture needle 6 .

或者，参照图22，植入件导向结构包括中部导向槽2c，中空穿刺针6形成有后端针孔，该后端针孔与中部导向槽2c沿轴向对位设置。在植入植入件11时，先利用辅助导向针12刺破中部导向槽2c，使辅助导向针12沿轴向对位于中空穿刺针6的后端针孔，然后使植入件11依次通过辅助导向针12的针腔和中空穿刺针6的后端针孔穿入中空穿刺针6的针腔，再进一步通过前端针孔6a植入显在或潜在组织间隙、腔系、脉管。Alternatively, referring to FIG. 22 , the implant guide structure includes acentral guide groove 2c, thehollow puncture needle 6 is formed with a rear needle hole, and the rear needle hole is axially aligned with thecentral guide groove 2c. When implanting theimplant 11, first use theauxiliary guide needle 12 to puncture themiddle guide groove 2c, make theauxiliary guide needle 12 align with the rear end needle hole of thehollow puncture needle 6 in the axial direction, and then let theimplant 11 pass through in sequence The needle lumen of theauxiliary guide needle 12 and the rear end needle hole of thehollow puncture needle 6 penetrate into the needle lumen of thehollow puncture needle 6, and then are further implanted into apparent or potential tissue spaces, lumens, and vessels through thefront needle hole 6a.

本发明的医用穿刺装置和医疗器具总成可用于眼部脉络膜上腔等腔系的探入、撑开、注射，以及药物、导管或其他医疗装置的植入。目前最常用的眼内注射方式是玻璃体腔注射，但某些药物或基因治疗载体穿透玻璃体后界膜和视网膜内层结构达到视网膜外层或视网膜色素上皮层的效率较低。此外，由于玻璃体腔是半开放腔体，玻璃体腔注射的药物容易随房水循环流出眼球，影响药物的局部浓度和药代动力学，也可能引起副作用，比如眼压升高和白内障。有些情况下，为了使药物或基因治疗载体能够在视网膜外层、视网膜色素上皮层和/或脉络膜达到有效浓度，可以将中空穿刺针在玻璃体腔一侧穿透视网膜至视网膜下或穿透视网膜及视网膜色素上皮至视网膜色素上皮下间隙，然后注射药物或基因治疗载体，注射难度较大且容易出现注射失败。The medical puncture device and medical appliance assembly of the present invention can be used for probing, expanding and injecting the suprachoroidal space and other cavities of the eye, as well as implanting drugs, catheters or other medical devices. At present, the most commonly used intraocular injection method is intravitreal injection, but the efficiency of some drugs or gene therapy carriers penetrating the posterior limiting membrane of the vitreous body and the inner retinal structure to reach the outer layer of the retina or the retinal pigment epithelium is low. In addition, since the vitreous cavity is a semi-open cavity, the drugs injected into the vitreous cavity are likely to flow out of the eyeball with the aqueous humor circulation, affecting the local concentration and pharmacokinetics of the drug, and may also cause side effects, such as increased intraocular pressure and cataracts. In some cases, in order to achieve an effective concentration of the drug or gene therapy vector in the outer retina, retinal pigment epithelium and/or choroid, a hollow puncture needle can be inserted into the subretina on the side of the vitreous cavity or through the retina and From the retinal pigment epithelium to the space under the retinal pigment epithelium, and then inject drugs or gene therapy vectors, the injection is difficult and prone to injection failure.

脉络膜上腔注射可以在脉络膜、视网膜色素上皮和/或视网膜外层实现较高药物浓度的给药途径，而且玻璃体药物浓度较低。Suprachoroidal injection allows for a route of administration with higher drug concentrations in the choroid, retinal pigment epithelium, and/or outer layers of the retina, with lower vitreous drug concentrations.

在一些情况下，比如脉络膜黑色素瘤，将治疗剂在脉络膜上腔进行精准的靶向注射，可能可以提高疗效和降低副作用。但对于眼部而言，其结构较小，要利用现有的装置或方法实现脉络膜上腔的探入、撑开、注射或导管等医疗装置置入是相当困难的，尤其是将导管等医疗装置置入脉络膜上腔的特定位置。In some cases, such as choroidal melanoma, precise targeted injection of therapeutic agents in the suprachoroidal space may improve efficacy and reduce side effects. But for the eye, its structure is small, it is very difficult to use the existing devices or methods to realize the insertion of the suprachoroidal space, expansion, injection or insertion of medical devices such as catheters, especially the insertion of medical devices such as catheters. The device is placed at a specific location in the suprachoroidal space.

有的脉络膜上腔的穿刺方法是使露出的穿刺针的长度和巩膜厚度相当，将穿刺针完全扎入巩膜后推注流体实现脉络膜上腔注射。这种穿刺方式的技术缺陷是预留的穿刺针的露出的长度和巩膜厚度可能不完全一致。实际应用中，不同人之间、眼之间以及同一眼不同部位之间巩膜厚度的差异会进一步放大上述技术缺陷。太短的针可能无法穿透巩膜，太长的针可能会越过脉络膜上腔并损害视网膜。因此现阶段还需研究出一种能够易于判断针端的穿刺深度的装置或方法。Some puncture methods for the suprachoroidal space are to make the length of the exposed puncture needle equal to the thickness of the sclera. After the puncture needle is completely inserted into the sclera, fluid is injected to realize suprachoroidal space injection. The technical defect of this puncture method is that the exposed length of the reserved puncture needle may not be completely consistent with the thickness of the sclera. In practical applications, differences in sclera thickness between different people, between eyes, and between different parts of the same eye will further amplify the above-mentioned technical defects. A needle that is too short may fail to penetrate the sclera, and a needle that is too long may pass over the suprachoroidal space and damage the retina. Therefore, at this stage, it is still necessary to develop a device or method that can easily judge the puncture depth of the needle tip.

由于眼内注射具有敏感性(例如组织的敏感性、对眼内压的潜在影响等)，许多已知的装置和方法都涉及手动注射。更具体地，许多已知的装置和方法需用户手动施力(例如，通过用其拇指或手指推动柱塞)以将流体(例如药物)排至眼内。由于针头尺寸小和/或所注射药物的特性，这类装置和方法不能让操作人员较为舒适地操作和施力，且在某些情况下，操作人员甚至无法正确地使用已知的装置和方法递送药物。Due to the sensitivity of intraocular injections (eg, tissue sensitivity, potential effects on intraocular pressure, etc.), many known devices and methods involve manual injection. More specifically, many known devices and methods require the user to manually apply force (eg, by pushing a plunger with their thumb or finger) to expel fluid (eg, medication) into the eye. Due to the small size of the needle and/or the nature of the drug being injected, such devices and methods are not comfortable for the operator to manipulate and apply force, and in some cases the operator is not even able to use the known devices and methods correctly Drug delivery.

此外，对眼部的不同目标层进行注射可以引起插入的针头和/或药物注射时所需的力的大小发生变化。眼部的不同层可具有不同的密度。例如，巩膜的密度通常高于结膜和脉络膜上腔。目标区域或目标层的密度差异可能会在针端口产生不同的外部压力。因此，与将药物注射到脉络膜上腔相比，注射到诸如巩膜之类的相对致密的眼部组织中需要更多的动力以将药物从针端口排出。此外，排出药物所需的注射力还取决于药物的密度和粘度以及针的长度和直径。通过针头(例如27G、30G或甚至更小的针头)将某些药物注射到眼部时可能需要施加一些难以估计和/或难以控制的力，这是为了在实现正确注射的同时又不会损坏眼部组织。In addition, injecting into different target layers of the eye can cause changes in the amount of needle inserted and/or the amount of force required to inject the drug. Different layers of the eye can have different densities. For example, the sclera is usually denser than the conjunctiva and suprachoroidal space. Density differences in the target area or target layer may generate different external pressures at the needle port. Therefore, injection into relatively dense ocular tissue such as the sclera requires more power to expel the drug from the needle port than injecting the drug into the suprachoroidal space. In addition, the injection force required to expel the drug depends on the density and viscosity of the drug as well as the length and diameter of the needle. Injecting certain medications into the eye through a needle (such as a 27G, 30G, or even smaller needle) may require some unpredictable and/or uncontrollable force in order to achieve a correct injection without damaging the eye tissue.

同样地，鉴于眼部结构相对较小，将器械置入眼内区域(例如用微创方法将导管或金属丝置入期望区域)也具有相当的挑战性。Likewise, placing instruments into the intraocular region (eg, minimally invasive methods of placing catheters or wires into the desired area) can be quite challenging given the relatively small size of the ocular structure.

而根据前述，通过采用本发明的医用穿刺装置和医疗器具总成，显然能够轻松地对脉络膜上腔等眼内区域实施注射、探入、扩张或器械植入操作，尤其可实现对穿刺深度的精准控制、稳定注液和定量注液。According to the foregoing, by adopting the medical puncture device and the medical appliance assembly of the present invention, it is obvious that the intraocular areas such as the suprachoroidal space can be easily injected, penetrated, expanded, or implanted, and in particular, the puncture depth can be adjusted. Precise control, stable injection and quantitative injection.

为了能够以最小的副损伤轻松穿刺，比如穿透巩膜到达脉络膜上腔，可采用针前端面为斜面的中空穿刺针6进行穿刺。中空穿刺针6还可设有狭窄针腔(例如，规格尺寸大于或等于30G、32G、34G或36G等)，既保证注射剂的递送，同时尽量减小针插入形成的针道的直径。此外，中空穿刺针6的针腔和前端斜面的纵横比与通常用于眼内注射的标准27G和30G针相同或不同。In order to easily puncture with minimal secondary damage, such as penetrating the sclera to reach the suprachoroidal space, ahollow puncture needle 6 with an inclined surface at the front end of the needle can be used for puncture. Thehollow puncture needle 6 can also be provided with a narrow needle cavity (for example, the specification size is greater than or equal to 30G, 32G, 34G or 36G, etc.), which not only ensures the delivery of the injection, but also minimizes the diameter of the needle track formed by the needle insertion. In addition, thehollow puncture needle 6 has the same or different aspect ratios of the needle lumen and front bevel as standard 27G and 30G needles commonly used for intraocular injections.

在一些实施例中，可将治疗剂(例如药物)添加到注射剂容纳区7内的注射剂中。特定药物和药物类别的非限制性例子包括β-肾上腺素受体拮抗剂(例如卡替洛尔、西他莫尔、倍他洛尔、左旋布洛尔、甲萘普洛尔、替莫洛尔)、模拟物(例如毛果芸香碱、卡巴胆碱、毒扁豆碱)、拟交感神经药(例如肾上腺素、浸润剂)、碳酸酐酶抑制剂(例如乙酰唑胺、多佐胺)、拓扑异构酶抑制剂(例如托泊替康、伊立替康、喜树碱、lamellarin D、依托泊苷、替尼泊苷、阿霉素、米托蒽醌、氨水ac碱)、前列腺素、抗微生物化合物，抗真菌药(例如氯霉素、金霉素、环丙沙星、曲霉菌素、夫西地酸、庆大霉素、新霉素、诺氟沙星、氧氟沙星、多粘菌素、四环素、妥布霉素、喹啉)、抗病毒化合物(例如阿昔洛韦、环丙韦多)、醛糖还原酶抑制剂、抗炎和/或抗过敏化合物(例如甾体化合物、如倍他米松、氯倍他松、地塞米松、洛美托龙、氢化可的松、泼尼松龙和非甾体化合物(例如安唑啉、溴芬酸、双氯芬酸、吲哚美辛、洛多沙胺、沙普芬、色甘酸钠)、人工泪液/干眼治疗剂、局部麻醉剂(例如甲氧卡因、利多卡因、奥布卡因、环丙沙星)、双氯芬酸、尿嘧啶酮和生长因子(如表皮生长因子、散瞳和睫状肌麻痹药、丝裂霉素C和胶原酶抑制剂)以及与年龄相关的黄斑变性的治疗剂(例如培加他尼钠、兰尼单抗、阿柏西布、贝伐单抗)。In some embodiments, a therapeutic agent (such as a drug) can be added to the injection in theinjection containing area 7 . Non-limiting examples of specific drugs and classes of drugs include beta-adrenoceptor antagonists (e.g., cartemolol, cetaxol, betaxolol, levoburolol, naprorolol, temolol mimetics (e.g., pilocarpine, carbachol, physostigmine), sympathomimetic agents (e.g., epinephrine, infiltrants), carbonic anhydrase inhibitors (e.g., acetazolamide, dorzolamide), topoisomers Enzyme inhibitors (eg, topotecan, irinotecan, camptothecin, lamellarin D, etoposide, teniposide, doxorubicin, mitoxantrone, amacrine), prostaglandins, antimicrobial compounds , antifungal agents (eg, chloramphenicol, aureomycin, ciprofloxacin, aspergillus, fusidic acid, gentamicin, neomycin, norfloxacin, ofloxacin, polymyxa tetracycline, tobramycin, quinoline), antiviral compounds (e.g. acyclovir, ciproviredol), aldose reductase inhibitors, anti-inflammatory and/or antiallergic compounds (e.g. steroids, Such as betamethasone, clobetasone, dexamethasone, lometolone, hydrocortisone, prednisolone and non-steroidal compounds (such as anzoline, bromfenac, diclofenac, indomethacin, lodoxamide, saprofen, cromolyn), artificial tears/dry eye treatments, local anesthetics (eg, methoxycaine, lidocaine, oxybucaine, ciprofloxacin), diclofenac, uracil Ketones and growth factors (eg, epidermal growth factor, mydriatic and cycloplegic drugs, mitomycin C, and collagenase inhibitors) and agents for age-related macular degeneration (eg, pegatanib, raney monoclonal antibody, aflibercib, bevacizumab).

在一些实施例中，治疗剂可以是整联蛋白拮抗剂、选择素拮抗剂、粘附分子拮抗剂(例如细胞间粘附分子(ICAM)-1、ICAM-2、ICAM-3、血小板内皮粘附分子(PCAM)、血管细胞粘附分子(VCAM)、诱导白细胞粘附的细胞因子或生长因子拮抗剂(例如肿瘤坏死因子-α(TNF-α)、白介素-1β(IL-1β)、单核细胞趋化蛋白-1(MCP-1)、血管内皮生长因子(VEGF))。In some embodiments, the therapeutic agent may be an integrin antagonist, a selectin antagonist, an adhesion molecule antagonist (e.g., intercellular adhesion molecule (ICAM)-1, ICAM-2, ICAM-3, platelet endothelial adhesion Adhesion molecules (PCAM), vascular cell adhesion molecules (VCAM), cytokines or growth factor antagonists that induce leukocyte adhesion (such as tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), monoclonal Nuclear cell chemoattractant protein-1 (MCP-1), vascular endothelial growth factor (VEGF)).

在一些实施例中，可通过前述的方法递送两种药物。两种药物能够以组合物制剂的形式给药或者以两种单独的制剂的形式按顺序给药。例如，提供了VEGF抑制剂和VEGF。VEGF抑制剂可以是抗体，例如人源化单克隆抗体、贝伐单抗、兰尼单抗等，也可以是阿柏西普或培加他尼。In some embodiments, both drugs may be delivered by the methods described previously. The two drugs can be administered in the form of a combined formulation or sequentially in the form of two separate formulations. For example, VEGF inhibitors and VEGF are provided. The VEGF inhibitor can be an antibody, such as a humanized monoclonal antibody, bevacizumab, ranibizumab, etc., or aflibercept or pegatanib.

在一些实施例中，本发明的医用穿刺装置可用于递送一种或多种以下的VEGF拮抗剂，包括AL8326、2C3抗体、AT001抗体、HyBEV、贝伐单抗(Avastin)、ANG3070、APX003抗体、APX004抗体、ponatinib(AP24534)、BDM-E、VGX100抗体(VGX100 CIRCADIAN)、VGX200(c-fos诱导的生长因子单克隆抗体)、VGX300、COSMIX、DLX903/1008抗体、ENMD2076、Sutent(苹果酸舒尼替尼)、INDUS815C、R84抗体、KD019、NM3、同种异体间充质前体细胞与抗VEGF试剂或抗体、MGCD265、MG516、VEGF-受体激酶抑制剂、MP0260、NT503、抗DLL4/VEGF双特异性抗体、PAN90806、Palomod 529、BD0801抗体、XV615、卢西替尼(AL3810、E3810)、AMG706(二磷酸莫沙尼布)、AAV2-sFLT01、可溶性Flt1受体、西地那尼(Recentin)、AV-951(替沃扎尼，KRN-951)、斯蒂伐加(regorafenib)、沃拉塞替尼(BI6727)、CEP11981、KH903、Lenvatinib(E7080)、terameprocol(EM1421)、兰尼单抗(Lucentis)、Votrient(盐酸帕唑帕尼)、PF00337210、PRS050、SP01(姜黄素)、羧酰胺基三唑乳清酸盐、羟氯喹、利尼法尼布(ABT869，RG3635)、伊卢文(氟轻松酮)、ALG1001、AGN150998、DARPin MP0112、AVAAP(101)、AMGAP(101)、AVAAP(351))、BMS690514、KH902、戈尔伐替尼(E7050)、Afinitor(依维莫司)、乳酸多维替尼(TKI258，CHIR258)、ORA101、ORA102、阿昔替尼(Inlyta，AG013736)、普立肽(Aplidin)、甲磺酸Lenvatinib、PTC299、阿弗来普(Aflibercept))、pegaptanib钠(Macugen、LI900015)、Visudyne(verteporfin)、bucillamine(Rimatil、Lamin、Brimani、Lamit、Boomiq)、R3抗体、AT001/r84抗体、肌钙蛋白(BLS0597)、EG3306、瓦他拉尼(PTK787)、Bmab100、GSK2136773、抗VEGFR替代酶、阿维拉，CEP7055、CLT009、ESBA903、HuMax-VEGF抗体、GW654652、HMPL010、GEM220、HYB676、JNJ17029259、TAK593、XtendVEGF抗体、Nova21012、Nova21013、CP564959、智能抗VEGF抗体、AG028262、AG13958、CVX241、SU14813、PRS055、PG501、PG545、PT1101、TG100948、I CS283、XL647、盐酸恩扎他汀(LY317615)、BC194、喹啉、COT601M06.1、COT604M06.2、MabionVEGF、与抗VEGF或VEGF-R抗体偶联的SIR-Spheres、阿帕替尼(YN968D1)和AL3818。In some embodiments, the medical puncture device of the present invention can be used to deliver one or more of the following VEGF antagonists, including AL8326, 2C3 antibody, AT001 antibody, HyBEV, bevacizumab (Avastin), ANG3070, APX003 antibody, APX004 antibody, ponatinib (AP24534), BDM-E, VGX100 antibody (VGX100 CIRCADIAN), VGX200 (c-fos-induced growth factor monoclonal antibody), VGX300, COSMIX, DLX903/1008 antibody, ENMD2076, Sutent (sunyl malate tinib), INDUS815C, R84 antibody, KD019, NM3, allogeneic mesenchymal precursor cells with anti-VEGF reagent or antibody, MGCD265, MG516, VEGF-receptor kinase inhibitor, MP0260, NT503, anti-DLL4/VEGF dual Specific antibody, PAN90806, Palomod 529, BD0801 antibody, XV615, lucitinib (AL3810, E3810), AMG706 (mosanib diphosphate), AAV2-sFLT01, soluble Flt1 receptor, cediranib (Recentin) , AV-951 (Tivozanib, KRN-951), Stivaga (regorafenib), Volacitinib (BI6727), CEP11981, KH903, Lenvatinib (E7080), terameprocol (EM1421), Ranibizumab (Lucentis), Votrient (pazopanib hydrochloride), PF00337210, PRS050, SP01 (curcumin), carboxamidotriazole orotate, hydroxychloroquine, linifarnib (ABT869, RG3635), iruven (fluocinone), ALG1001, AGN150998, DARPin MP0112, AVAAP(101), AMGAP(101), AVAAP(351)), BMS690514, KH902, Golvatinib (E7050), Afinitor (everolimus), Dovitinib lactate (TKI258, CHIR258), ORA101, ORA102, axitinib (Inlyta, AG013736), Aplidin, Lenvatinib mesylate, PTC299, Aflibercept), pegaptanib sodium ( Macugen, LI900015), Visudyne (verteporfin), bucillamine (Rimatil, Lamin, Brimani, Lamit, Boomiq), R3 antibody, AT001/r 84 antibody, troponin (BLS0597), EG3306, vatalanib (PTK787), Bmab100, GSK2136773, anti-VEGFR replacement enzyme, Avela, CEP7055, CLT009, ESBA903, HuMax-VEGF antibody, GW654652, HMPL010, GEM220, HYB676、JNJ17029259、TAK593、XtendVEGF抗体、Nova21012、Nova21013、CP564959、智能抗VEGF抗体、AG028262、AG13958、CVX241、SU14813、PRS055、PG501、PG545、PT1101、TG100948、I CS283、XL647、盐酸恩扎他汀(LY317615) , BC194, quinoline, COT601M06.1, COT604M06.2, MabionVEGF, SIR-Spheres conjugated to anti-VEGF or VEGF-R antibody, apatinib (YN968D1) and AL3818.

另外，VEGF抑制剂或VEGF拮抗剂可以与本文列出的一种或多种药剂或与本领域已知的其他药剂组合。Additionally, a VEGF inhibitor or VEGF antagonist may be combined with one or more of the agents listed herein or with other agents known in the art.

本发明的医用穿刺装置和医疗器具总成还可用于青光眼的治疗。The medical puncture device and medical appliance assembly of the present invention can also be used for the treatment of glaucoma.

青光眼是一种影响数百万人的眼疾，其病因与眼内压升高有关，该升高是由于眼部引流系统无法从前房充分引流房水或睫状体产生过多房水而引起的。房水的积聚和由此产生的眼内压升高可能会导致视神经和视网膜的不可逆损伤，严重时甚至会失明。Glaucoma, an eye disease affecting millions, is associated with an increase in intraocular pressure caused by the inability of the ocular drainage system to adequately drain the aqueous humor from the anterior chamber or excessive production of aqueous humor from the ciliary body . The accumulation of aqueous humor and the resulting increase in intraocular pressure may cause irreversible damage to the optic nerve and retina, and in severe cases, even blindness.

具体地，青光眼有开角型和闭角型两种主要类型。开角型青光眼是指眼内压升高但前房角(引流角)保持开放的青光眼类型，常见病因是小梁网阻塞。而闭角型青光眼是指由于前房角部分或完全闭合而导致眼内压升高的青光眼类型，在此类青光眼中，虹膜肿胀、粘连或前移关闭前房角并阻止液体进入小梁网，从而阻碍房水从眼中流出。Specifically, there are two main types of glaucoma, open-angle type and angle-closure type. Open-angle glaucoma is a type of glaucoma in which the intraocular pressure is elevated but the anterior chamber angle (drainage angle) remains open. The common cause is obstruction of the trabecular meshwork. Angle-closure glaucoma, on the other hand, is a type of glaucoma in which intraocular pressure increases due to partial or complete closure of the anterior chamber angle. In this type of glaucoma, the iris swells, adheres, or moves forward to close the anterior chamber angle and prevent fluid from entering the trabecular meshwork. , thereby preventing the outflow of aqueous humor from the eye.

目前，青光眼可通过外科手术治疗，治疗方法涉及在眼内放置引流装置以在前房和眼部的各种结构之间形成房水引流(例如结膜下引流、Schlemm’s管引流以及脉络膜上腔引流)通路。而植入引流装置的外科手术可以是先将用于放置引流装置的输送装置插入眼内特定部位，然后再将引流装置植入。Currently, glaucoma is treated surgically, which involves the placement of drainage devices in the eye to create a drainage of aqueous humor between the anterior chamber and various structures in the eye (such as subconjunctival, Schlemm's tube, and suprachoroidal drainage) path. The surgical procedure for implanting the drainage device can be to first insert the delivery device used to place the drainage device into a specific part of the eye, and then implant the drainage device.

在一些现有治疗方法中，用于放置引流装置的输送装置可通过角膜进入眼内(内路穿刺)，在前房中穿行并伸入到对侧房角，直到该输送装置的前端部分接近房水的流出部位时，放置引流装置，从而在前房和房水的流出部位之间形成房水引流通路。而在另一些现有治疗方法中，用于保持引流装置的输送装置使用的是外路穿刺的方法进入眼内，此方法涉及通过巩膜插入的步骤。In some existing treatments, the delivery device used to place the drainage device is passed through the cornea into the eye (endopuncture), passed through the anterior chamber and into the contralateral angle until the tip portion of the delivery device approaches At the outflow site of aqueous humor, a drainage device is placed to form an aqueous humor drainage channel between the anterior chamber and the outflow site of aqueous humor. In other existing treatments, the delivery device used to hold the drainage device is entered into the eye using an external puncture method that involves a step of insertion through the sclera.

但目前从外路植入的脉络膜上腔房水引流装置的手术方法需要全层切开巩膜，创伤较大且手术时间较长，而内路植入的脉络膜上腔房水引流装置的手术方法则无法对穿刺深度进行精准控制，容易过度穿刺而损伤其他眼部组织，或因穿刺深度不足而无法进行正常植入。此外，结膜下腔的外路和内路植入手术方法也存在无法对穿刺深度进行精准控制的问题。由此可见，目前治疗青光眼的脉络膜和结膜下的房水引流装置的手术方法仍具有较大的改进空间。However, the current surgical method of implanting the suprachoroidal aqueous humor drainage device through the external route requires full-thickness incision of the sclera. It is impossible to precisely control the puncture depth, and it is easy to damage other eye tissues due to excessive puncture, or normal implantation cannot be performed due to insufficient puncture depth. In addition, there is also the problem of inability to accurately control the puncture depth in the external and internal implantation methods of the subconjunctival cavity. It can be seen that the current surgical methods for treating glaucoma with choroidal and subconjunctival aqueous humor drainage devices still have a lot of room for improvement.

为了解决目前用于治疗青光眼的装置和手术方法中的至少一种缺陷或不足，本发明可采用上述的医用穿刺装置或医疗器具总成进行青光眼治疗。具体地，通过以脉络膜上腔和/或结膜下腔作为目标房水流出区域，或在目标流出区域和流入区域(例如前房)之间进行探入、扩张或器械植入(例如植入引流装置)，有助于从前房排出房水。In order to solve at least one defect or deficiency in the current devices and surgical methods for treating glaucoma, the present invention can use the above-mentioned medical puncture device or medical appliance assembly to treat glaucoma. Specifically, by targeting the suprachoroidal space and/or subconjunctival space as the outflow area of aqueous humor, or between the targeted outflow area and the inflow area (eg, anterior chamber) by probing, dilating, or implanting (eg, implanting drainage device) to help drain the aqueous humor from the anterior chamber.

首先提供一种用于将引流装置植入眼内的方法，该方法包括：(a)将针插入眼内以在眼内形成输送通道，其中该输送通道终止于眼内的目标房水流出区域；(b)通过针输送流体，以在目标流出区域形成扩大空间；(c)将引流装置的流入端定位在前房中，并将引流装置的流出端定位在扩大空间中，其中，引流装置可释放地连接于针；以及(d)从引流装置中释放针，从而将引流装置植入眼内，以在前房和目标流出区域之间形成流体连通。There is first provided a method for implanting a drainage device in an eye, the method comprising: (a) inserting a needle into the eye to form a delivery channel in the eye, wherein the delivery channel terminates in a targeted aqueous humor outflow region in the eye (b) delivering fluid through the needle to create an enlarged space in the targeted outflow area; (c) positioning the inflow end of the drainage device in the anterior chamber and positioning the outflow end of the drainage device in the enlarged space, wherein the drainage device releasably connected to the needle; and (d) releasing the needle from the drainage device, thereby implanting the drainage device in the eye to establish fluid communication between the anterior chamber and the targeted outflow region.

在一些实施例中，使针刺穿巩膜。可选地，上述方法包括在针刺穿巩膜之前行结膜切开。可选地，使针刺穿结膜和巩膜，并且上述方法不包括在结膜切开。可选地，目标流出区域在巩膜和脉络膜之间，扩大空间是脉络膜上腔。可选地，上述定位步骤包括将针的前端定位在脉络膜上腔中并朝向前房角。In some embodiments, the needle is pierced through the sclera. Optionally, the method described above includes performing a conjunctival incision prior to the needle piercing the sclera. Optionally, the needle is pierced through the conjunctiva and sclera, and the method described above does not include incision in the conjunctiva. Optionally, the target outflow region is between the sclera and the choroid, and the enlarged space is the suprachoroidal space. Optionally, the positioning step includes positioning the tip of the needle in the suprachoroidal space and towards the anterior chamber angle.

在一些实施例中，引流装置设置在针内。可选地，引流装置设置在针的针腔中，或者引流装置形成为套设在针外的套管。In some embodiments, the drainage device is disposed within the needle. Optionally, the drainage device is arranged in the needle lumen of the needle, or the drainage device is formed as a cannula sleeved outside the needle.

在一些实施例中，上述定位步骤包括使引流装置从针腔内前进至针的前端或者使套设在针外的引流装置前进至针的前端。可选地，前进包括使用导丝将引流装置推至针腔内或套设在针外。可选地，上述定位步骤包括用针和/或引流装置的前端刺穿前房角。可选地，上述释放步骤包括从眼内移出针和/或导丝，将引流装置的流入端留在前房，将引流装置的流出端留在脉络膜上腔。In some embodiments, the positioning step includes advancing the drainage device from the needle lumen to the front end of the needle or advancing the drainage device sheathed outside the needle to the front end of the needle. Optionally, advancing includes using a guide wire to push the drainage device into the needle lumen or over the needle. Optionally, the above positioning step includes piercing the anterior chamber angle with a needle and/or the front end of the drainage device. Optionally, the releasing step includes removing the needle and/or guide wire from the eye, leaving the inflow end of the drainage device in the anterior chamber, and leaving the outflow end of the drainage device in the suprachoroidal space.

在一些实施例中，使引流装置在插入步骤之前或之后连接到针。可选地，引流装置在输送流体之前或之后与针连接。可选地，引流装置可释放地连接到针的前端。In some embodiments, the drain device is attached to the needle either before or after the inserting step. Optionally, the drainage device is connected to the needle either before or after delivering the fluid. Optionally, the drainage device is releasably attached to the forward end of the needle.

在一些实施例中，上述定位步骤包括使引流装置朝向前房角定位。可选地，上述定位步骤包括使针前进以与引流装置的前端刺穿前房角。可选地，上述释放步骤包括取下针，将引流装置的流入端留在前房，将引流装置的流出端留在脉络膜上腔。In some embodiments, the positioning step includes positioning the drainage device toward the anterior chamber angle. Optionally, the positioning step includes advancing the needle to penetrate the anterior chamber angle with the front end of the drainage device. Optionally, the releasing step includes removing the needle, leaving the inflow end of the drainage device in the anterior chamber, and leaving the outflow end of the drainage device in the suprachoroidal space.

在一些实施例中，上述定位步骤包括将针的前端定位在脉络膜上腔并远离前房角。可选地，使引流装置设置在针内，其中使引流装置设置在针的针腔内，或者使引流装置形成为套设在针外的套管。可选地，上述定位步骤包括使引流装置从针腔内前进至针的前端或者使套设在针外的引流装置前进至针的前端。可选地，前进包括使用导丝将引流装置推至针腔内或套设在针外。可选地，上述定位步骤包括将引流装置的流出端定位在脉络膜上腔并且远离前房角。可选地，上述定位步骤包括从眼内移出针，将引流装置的流出端留在脉络膜上腔。In some embodiments, the positioning step includes positioning the tip of the needle in the suprachoroidal space and away from the anterior chamber angle. Optionally, the drainage device is arranged in the needle, wherein the drainage device is arranged in the needle lumen of the needle, or the drainage device is formed as a sleeve sleeved outside the needle. Optionally, the positioning step includes advancing the drainage device from the needle cavity to the front end of the needle or advancing the drainage device sheathed outside the needle to the front end of the needle. Optionally, advancing includes using a guide wire to push the drainage device into the needle lumen or over the needle. Optionally, the positioning step includes positioning the outflow end of the drainage device in the suprachoroidal space and away from the anterior chamber angle. Optionally, the positioning step includes removing the needle from the eye, leaving the outflow end of the drainage device in the suprachoroidal space.

在一些实施例中，上述方法进一步包括刺穿前房角以形成植入件通道。可选地，使引流装置的流入端通过前房中的植入件通道定位。可选地，植入件通道可采用相同的针或不同的穿刺元件形成。可选地，可采用同一根针或不同的穿刺元件刺穿结膜、巩膜、脉络膜上腔和前房角。可选地，可在第一入口点将针插入眼内，并且可在与第一入口点不同的第二入口点将相同的针或不同的刺穿元件插入眼内以形成植入件通道。In some embodiments, the above method further comprises piercing the anterior chamber angle to form the implant channel. Optionally, the inflow end of the drainage device is positioned through the implant channel in the anterior chamber. Alternatively, implant channels may be formed using the same needle or different piercing elements. Alternatively, the conjunctiva, sclera, suprachoroidal space, and anterior chamber angle can be pierced with the same needle or different piercing elements. Alternatively, a needle may be inserted into the eye at a first entry point, and the same needle or a different piercing element may be inserted into the eye at a second entry point different from the first entry point to form the implant channel.

在一些实施例中，引流装置的流出端包括位于巩膜外侧的第一和第二进入点之间的部分。可选地，引流装置的流出端包括位于巩膜和结膜外侧的第一和第二进入点之间的部分。可选地，巩膜外侧的部分是在结膜下的。可选地，上述方法包括切开结膜以暴露巩膜，并且在通过前房中的植入件通道定位引流装置的流入端之后，缝合结膜以覆盖引流装置在巩膜外的部分。可选地，引流装置在巩膜外侧的部分包括引流装置分流口，其中，引流装置分流口可以位于结膜下。In some embodiments, the outflow end of the drainage device includes a portion located outside the sclera between the first and second entry points. Optionally, the outflow end of the drainage device includes a portion between the first and second entry points outside the sclera and conjunctiva. Optionally, the portion outside the sclera is subconjunctival. Optionally, the above method includes incising the conjunctiva to expose the sclera, and suturing the conjunctiva to cover the extrascleral portion of the drainage device after positioning the inflow end of the drainage device through the implant channel in the anterior chamber. Optionally, the part of the drainage device outside the sclera includes a diversion port of the drainage device, wherein the diversion port of the drainage device may be located under the conjunctiva.

在一些实施例中，上述方法包括在打开的结膜下放置抗代谢药。In some embodiments, the above methods comprise placing an antimetabolite under the opened conjunctiva.

在一些实施例中，使针从外路或内路插入眼内。In some embodiments, the needle is inserted into the eye either externally or internally.

在一些实施例中，目标流出区域在结膜和巩膜之间，并且扩大空间是结膜下腔。可选地，引流装置设置在针腔内。可选地，引流装置形成为套设在针外的套管，或者引流装置可释放地连接在针的前端。In some embodiments, the target outflow region is between the conjunctiva and sclera, and the enlarged space is the subconjunctival space. Optionally, the drainage device is arranged in the needle cavity. Optionally, the drainage device is formed as a cannula sheathed on the outside of the needle, or the drainage device is releasably connected to the front end of the needle.

在一些实施例中，提供另一种用于将引流装置植入眼内的方法，该方法包括：(a)将针插入眼内以在眼内形成输送通道，其中输送通道终止于巩膜和脉络膜之间；(b)通过针输送流体以形成脉络膜上腔；(c)用针的前端和/或可释放地连接到针上的引流装置刺入前房角；(d)通过前房角放置引流装置，使引流装置的流入端位于前房，引流装置的流出端位于脉络膜上腔；以及(e)从眼内移出针，从而将引流装置植入眼内，以使得前房和脉络膜上腔之间连通。In some embodiments, another method for implanting a drainage device in an eye is provided, the method comprising: (a) inserting a needle into the eye to form a delivery channel in the eye, wherein the delivery channel terminates in the sclera and choroid (b) deliver fluid through the needle to create the suprachoroidal space; (c) penetrate the anterior chamber angle with the tip of the needle and/or a drainage device releasably attached to the needle; (d) place through the anterior chamber angle a drainage device such that the inflow end of the drainage device is in the anterior chamber and the outflow end of the drainage device is in the suprachoroidal space; and (e) removing the needle from the eye so that the drainage device is implanted in the eye so that the anterior chamber and suprachoroidal space connected between.

在一些实施例中，提供另一种用于将引流装置植入眼内的方法，该方法包括：(a)将针插入眼内以在眼内形成输送通道，其中输送通道终止于巩膜和脉络膜之间；(b)通过针输送流体以形成脉络膜上腔；(c)用针将引流装置的流出端放置在脉络膜上腔内并远离前房角；(d)刺入前房角以形成植入件通道；(e)将引流装置的流入端通过植入件通道定位在前房中，从而将引流装置放置在眼内，以使得前房和脉络膜上腔之间连通。In some embodiments, another method for implanting a drainage device in an eye is provided, the method comprising: (a) inserting a needle into the eye to form a delivery channel in the eye, wherein the delivery channel terminates in the sclera and choroid (b) delivering fluid through the needle to create the suprachoroidal space; (c) using the needle to place the outflow end of the drainage device in the suprachoroidal space away from the anterior chamber angle; (d) piercing the anterior chamber angle to create an implant (e) positioning the inflow end of the drainage device through the implant channel in the anterior chamber, thereby placing the drainage device in the eye to allow communication between the anterior chamber and the suprachoroidal space.

在一些实施例中，引流装置的一部分位于巩膜外。可选地，巩膜外引流的部分位于结膜下。可选地，引流装置的一部分可以位于巩膜和结膜之外。可选地，引流装置包括位于巩膜和结膜外的引流装置分流口和/或位于结膜外的引流装置分流口。可选地，引流装置在前房和脉络膜上腔之间以及前房和结膜下腔之间提供流体连通。可选地，引流装置在前房和脉络膜上腔之间以及前房和结膜外空间之间提供流体连通。In some embodiments, a portion of the drainage device is located extrasclera. Optionally, a portion of the episcleral drainage is subconjunctival. Optionally, a portion of the drainage device may be located outside the sclera and conjunctiva. Optionally, the drainage device includes a drainage device shunt port located outside the sclera and conjunctiva and/or a drainage device shunt port located outside the conjunctiva. Optionally, a drainage device provides fluid communication between the anterior chamber and the suprachoroidal space and between the anterior chamber and the subconjunctival space. Optionally, a drainage device provides fluid communication between the anterior chamber and the suprachoroidal space and between the anterior chamber and the extraconjunctival space.

在一些实施例中，提供一种用于将引流装置从内路植入眼内的方法，该方法包括：(a)使针和/或可释放地连接在针上的引流装置依次穿过角膜和前房以穿至脉络膜上腔或结膜下腔；(b)通过针和/或引流装置将流体输送到脉络膜上腔或结膜下腔；(c)将引流装置的流入端置入前房，将引流装置的流出端置入脉络膜上腔或结膜下腔；以及(d)从眼中移出针头，从而将引流装置植入眼内，以在前房与脉络膜上腔或结膜下腔之间提供流体连通。In some embodiments, there is provided a method for internally implanting a drainage device into an eye, the method comprising: (a) sequentially passing a needle and/or a drainage device releasably attached to the needle through the cornea and the anterior chamber to penetrate the suprachoroidal or subconjunctival space; (b) deliver fluid to the suprachoroidal or subconjunctival space through a needle and/or drainage device; (c) place the inflow end of the drainage device into the anterior chamber, Placement of the outflow end of the drainage device into the suprachoroidal or subconjunctival space; and (d) removal of the needle from the eye, thereby implanting the drainage device in the eye to provide fluid between the anterior chamber and the suprachoroidal or subconjunctival space connected.

在一些实施例中，引流装置内含有药物或生物制剂。In some embodiments, the drainage device contains a drug or biological agent.

在一些实施例中，引流装置被设置为向前穿行或沿针前进，并且在针到达目标流出区域时在针的前端暴露。In some embodiments, the drainage device is configured to pass forwardly or along the needle and is exposed at the forward end of the needle when the needle reaches the targeted outflow region.

在一些实施例中，引流装置为设置在针内的眼内引流装置。In some embodiments, the drainage device is an intraocular drainage device disposed within a needle.

参照图23至图29，现具体描述一种用于将引流装置植入眼内的方法。首先将针穿过结膜和巩膜插入眼内以在眼内形成输送通道，其中输送通道终止于巩膜和脉络膜之间。诸如具有粘弹性的流体通过针输送，以在巩膜和脉络膜之间形成脉络膜上腔。然后将针旋转至使得针的前端朝向前房角定位，由于脉络膜上腔已通过粘弹性流体扩大，因此具有更多空间以便于调节针的前端的朝向，而不会对脉络膜或其他周围的眼组织造成损伤。接下来，移动针以使得针的前端刺穿前房角，从而使针的前端开口暴露在前房中。然后便可将引流装置插入针内(或者也可以在插入针和注入流体之前将引流装置预先插入到针内)并移动至从针的前端开口伸出。如此便可将引流装置定位成通过前房角，使得引流装置的流入端置入前房，且引流装置的流出端置入脉络膜上腔。放置好引流装置后，将针从眼内移出，使引流装置留置在眼内，以在前房和脉络膜上腔之间提供流体连通。Referring to Figures 23 to 29, a method for implanting a drainage device in an eye will now be described in detail. A needle is first inserted into the eye through the conjunctiva and sclera to create a delivery channel in the eye, where the delivery channel terminates between the sclera and choroid. A fluid such as viscoelasticity is delivered through the needle to create a suprachoroidal space between the sclera and the choroid. The needle is then rotated so that the tip of the needle is positioned towards the anterior chamber angle, since the suprachoroidal space has been enlarged by the viscoelastic fluid, there is more room to adjust the orientation of the tip of the needle without disturbing the choroid or other surrounding ocular tissue damage. Next, the needle is moved such that the tip of the needle pierces the anterior chamber angle, thereby exposing the opening of the tip of the needle into the anterior chamber. The drainage device can then be inserted into the needle (or the drainage device can also be pre-inserted into the needle prior to inserting the needle and injecting fluid) and moved to protrude from the front opening of the needle. This allows the drainage device to be positioned across the anterior chamber angle such that the inflow end of the drainage device is placed into the anterior chamber and the outflow end of the drainage device is placed into the suprachoroidal space. After the drain is placed, the needle is removed from the eye, leaving the drain in the eye to provide fluid communication between the anterior chamber and the suprachoroidal space.

可见，上述图示实施例的方法是一种微创方法，无需通过手术整层切断巩膜，或手术分离巩膜和脉络膜，或在手术后缝合切开的巩膜或结膜。因此该微创方法可以减少眼部组织损伤，降低对外科技术的要求，并节省手术时间。It can be seen that the method of the above-mentioned illustrated embodiment is a minimally invasive method, and it is not necessary to cut off the sclera through surgery, or to separate the sclera and choroid, or to suture the cut sclera or conjunctiva after the operation. Therefore, this minimally invasive method can reduce eye tissue damage, reduce the requirements for surgical techniques, and save operation time.

参照图30至图36，或图37至图42，现具体描述另一种用于将引流装置植入眼内的方法。首先将针穿过结膜和巩膜插入眼内以在眼内形成输送通道，其中输送通道终止于巩膜和脉络膜之间。诸如具有粘弹性的流体通过针输送，以在巩膜和脉络膜之间形成脉络膜上腔。然后将针旋转至使得针的前端远离前房角定位。由于脉络膜上腔已通过流体扩大，因此具有更多空间以便于调节针的前端的朝向，而不会对脉络膜或其他周围的眼组织造成损伤。接下来，将引流装置插入针内(或者也可以在插入针和注入流体之前将引流装置预先插入到针内)，并将引流装置置于针的前端，然后将针取出，使得引流装置的流出端位于远离前房角的位置，而另一端则位于巩膜外侧。进一步地，使用相同或不同的针(不一定是空心的)刺穿巩膜，并穿过脉络膜上腔和前房角，形成植入件通道。然后将引流装置的另一端插入植入件通道，以将引流装置的流入端置于前房，从而将引流装置植入眼内，以提供前房和脉络膜上腔之间的流体连通。Referring to Fig. 30 to Fig. 36, or Fig. 37 to Fig. 42, another method for implanting the drainage device in the eye will now be described in detail. A needle is first inserted into the eye through the conjunctiva and sclera to create a delivery channel in the eye, where the delivery channel terminates between the sclera and choroid. A fluid such as viscoelasticity is delivered through the needle to create a suprachoroidal space between the sclera and the choroid. The needle is then rotated such that the tip of the needle is positioned away from the anterior chamber angle. Since the suprachoroidal space has been enlarged by fluid, there is more room to adjust the orientation of the tip of the needle without causing damage to the choroid or other surrounding ocular tissue. Next, the drainage device is inserted into the needle (or the drainage device can also be pre-inserted into the needle before inserting the needle and injecting fluid), and the drainage device is placed on the front end of the needle, and then the needle is withdrawn to allow the drainage device to flow out. One end is located away from the anterior chamber angle, while the other end is located lateral to the sclera. Further, the same or a different needle (not necessarily hollow) is used to pierce the sclera and pass through the suprachoroidal space and anterior chamber angle to create a channel for the implant. The other end of the drainage device is then inserted into the implant channel to place the inflow end of the drainage device in the anterior chamber, thereby implanting the drainage device in the eye to provide fluid communication between the anterior chamber and the suprachoroidal space.

在上述图示实施例的方法中，引流装置的一部分被置于巩膜外，例如置于结膜下或结膜外。而且，被置于巩膜外的引流装置部分可形成有引流装置分流口，从而使得引流装置可同时在前房和脉络膜上腔之间以及前房和结膜下腔之间提供流体连通，或者可同时在前房和脉络膜上腔之间以及前房和结膜外的空间之间提供流体连通，实现双引流效果。In the methods of the illustrated embodiments above, a portion of the drainage device is placed extrascleraally, eg, subconjunctivally or extraconjunctivally. Also, the portion of the drain that is positioned extrasclera may be formed with a drain shunt such that the drain may provide fluid communication between the anterior chamber and the suprachoroidal space and between the anterior chamber and the subconjunctival space simultaneously, or may simultaneously Provides fluid communication between the anterior chamber and the suprachoroidal space and between the anterior chamber and the extraconjunctival space for a dual drainage effect.

需要说明的是，引流装置的流入端、流出端和/或引流装置分流口可包括一个或多个阀，例如单向阀，以例如控制流体只能从前房单向流出。例如，可控制流体流动，使得流体只能从前房流到引流装置流出端(即，例如流到脉络膜上腔或结膜下腔)和/或引流装置分流口(即，例如流到结膜下腔或结膜外)，而不会从引流装置流出端或引流装置分流口反向流入前房，从而保证引流装置实现降低眼内压的作用。It should be noted that the inflow end, the outflow end and/or the diversion port of the drainage device may include one or more valves, such as one-way valves, for example to control fluid to flow out from the anterior chamber only in one direction. For example, fluid flow can be controlled so that fluid can only flow from the anterior chamber to the outflow port of the drainage device (i.e., for example, to the suprachoroidal or subconjunctival space) and/or the shunt port of the drainage device (i.e., for example, to the subconjunctival or outside the conjunctiva), and will not reversely flow into the anterior chamber from the outflow end of the drainage device or the shunt port of the drainage device, so as to ensure that the drainage device can reduce the intraocular pressure.

参照图43至图45，现具体描述一种采用本发明的医用穿刺装置(或医疗器具总成)以将引流装置从内路植入眼内的方法。首先使医用穿刺装置的中空穿刺针穿过角膜和前房以插入结膜下腔(或脉络膜上腔)。诸如具有粘弹性的流体通过中空穿刺针进入结膜下腔，从而撑大结膜下腔。然后通过中空穿刺针植入引流装置，以将引流装置的流出端置于结膜下腔，且拔出中空穿刺针后，使引流装置的流入端置于前房，从而提供前房和结膜下腔之间的流体连通。Referring to Fig. 43 to Fig. 45, a method of using the medical puncture device (or medical device assembly) of the present invention to implant the drainage device into the eye from the inner channel will now be described in detail. First, the hollow puncture needle of the medical puncture device is inserted through the cornea and anterior chamber to insert into the subconjunctival space (or suprachoroidal space). A fluid such as viscoelasticity is passed through the hollow needle into the subconjunctival space, thereby expanding the subconjunctival space. The drainage device is then implanted through the hollow puncture needle to place the outflow end of the drainage device in the subconjunctival space, and after the hollow puncture needle is pulled out, the inflow end of the drainage device is placed in the anterior chamber, thereby providing anterior chamber and subconjunctival space fluid communication between them.

与现有的内路植入手术方法相比，上述图示实施例的方法能够精准控制对结膜下腔的注射和扩张，从而有效降低或避免中空穿刺针刺穿结膜的风险。Compared with the existing internal implantation method, the method of the above illustrated embodiment can precisely control the injection and expansion of the subconjunctival cavity, thereby effectively reducing or avoiding the risk of the hollow puncture needle piercing the conjunctiva.

为使本发明的医用穿刺装置和医疗器具总成适用于眼部的显在或潜在组织间隙、腔系、脉管的注射、探入、扩张或器械植入，特别是适用于脉络膜上腔和青光眼的治疗，结合前述的实施例，医用穿刺装置可进一步形成为眼部穿刺装置，医疗器具总成可进一步形成为眼部植入器具总成。In order to make the medical puncture device and medical appliance assembly of the present invention suitable for the injection, exploration, expansion or device implantation of the obvious or potential tissue spaces, cavities and blood vessels of the eye, especially for the suprachoroidal space and For the treatment of glaucoma, in combination with the foregoing embodiments, the medical puncture device can be further formed into an eye puncture device, and the medical device assembly can be further formed into an eye implant device assembly.

下面将补充描述眼部穿刺装置有别于本发明具有通用性的医用穿刺装置的一些特征，以及补充描述眼部植入器具总成有别于本发明具有通用性的医疗器具总成的一些特征。且在本发明中，具有通用性的医用穿刺装置和医疗器具总成的前述所有实施例，均可应用在眼部穿刺装置和眼部植入器具总成中。Some features of the ocular puncture device that are different from the general medical puncture device of the present invention will be supplemented below, and some features of the ocular implant device assembly that are different from the general medical device assembly of the present invention will be supplemented . And in the present invention, all the aforementioned embodiments of the universal medical puncture device and medical device assembly can be applied to the eye puncture device and the eye implant device assembly.

对于眼部穿刺装置，其注射剂容纳区7中预先储存有适用于眼部注射的眼部注射剂，可参考前述列举的注射剂种类，包括用于治疗眼部疾病(例如青光眼、脉络膜上腔或结膜下腔疾病)的眼部治疗剂，或者是能够在注入并撑大眼部的显在或潜在组织间隙、腔系、脉管(例如脉络膜上腔和结膜下腔)后定型的可定型眼部注射剂。For the eye puncture device, eye injections suitable for eye injections are pre-stored in itsinjection containing area 7, which can refer to the types of injections listed above, including those used for the treatment of eye diseases (such as glaucoma, suprachoroidal space or subconjunctiva). luminal disease) or formable ocular injectables capable of setting after infusion and enlargement of apparent or potential tissue spaces, cavities, and vessels of the eye (e.g., suprachoroidal and subconjunctival spaces) .

为适于眼部穿刺，中空穿刺针6可采用30G至23G规格In order to be suitable for eye puncture, thehollow puncture needle 6 can adopt the specification of 30G to 23G

适于眼部植入的植入件11为眼部植入件，由前述的眼部手术方法可知，根据眼部植入件的安装和植入方式的差异，可大致将眼部植入件分为三种类型。其中，第一类眼部植入件预安装在中空穿刺针6的针腔内且能够前行至从前端针孔6a释放。第二类眼部植入件套设在中空穿刺针6外且能够前行至从中空穿刺针6的前端释放。第三类眼部植入件可释放地连接在中空穿刺针6的前端。Theimplant 11 suitable for ocular implantation is an ocular implant. As can be seen from the aforementioned eye surgery methods, according to the difference in the installation and implantation of the ocular implant, the ocular implant can be roughly Divided into three types. Wherein, the first type of ocular implant is pre-installed in the needle cavity of thehollow puncture needle 6 and can be advanced to be released from theneedle hole 6a at the front end. The second type of eye implant is sheathed outside thehollow puncture needle 6 and can move forward to be released from the front end of thehollow puncture needle 6 . The third type of ocular implant is releasably connected to the front end of thehollow puncture needle 6 .

进一步地，第一类眼部植入件、第二类眼部植入件和第三类眼部植入件均可包括前述适用于青光眼引流治疗的引流装置。Further, the first type of ocular implant, the second type of ocular implant and the third type of ocular implant may all include the aforementioned drainage device suitable for drainage treatment of glaucoma.

当应用于脉络膜上腔穿刺时，眼部穿刺装置包括在中空穿刺针6刺破针筒前封闭端之后的巩膜穿刺状态，在巩膜穿刺状态下，中空穿刺针6从针筒前封闭端伸出的长度范围为巩膜穿刺长度范围，在巩膜穿刺长度范围内，优选地，周壁针孔6b至少部分连通注射剂容纳区7。When applied to suprachoroidal space puncture, the ocular puncture device includes a sclera puncture state after thehollow puncture needle 6 punctures the front closed end of the syringe, and in the scleral puncture state, thehollow puncture needle 6 protrudes from the front closed end of the syringe The length range of is the scleral puncture length range, within the scleral puncture length range, preferably, the peripheralwall needle hole 6b at least partially communicates with theinjection containing area 7.

当应用于脉络膜上腔穿刺时，眼部穿刺装置还包括在中空穿刺针6刺破针筒前封闭端之后的脉络膜上腔导流状态，在脉络膜上腔导流状态下，中空穿刺针6从针筒前封闭端伸出的长度范围为脉络膜上腔导流长度范围，在脉络膜上腔导流长度范围内，优选地，周壁针孔6b位于注射剂容纳区7内。When applied to suprachoroidal space puncture, the eye puncture device also includes a suprachoroidal space diversion state after thehollow puncture needle 6 punctures the front closed end of the syringe, and in the suprachoroidal space diversion state, thehollow puncture needle 6 from The extended length range of the front closed end of the syringe is the range of the drainage length of the suprachoroidal space, and within the range of the drainage length of the suprachoroidal space, preferably, the peripheralwall needle hole 6 b is located in theinjection accommodation area 7 .

当应用于结膜下腔穿刺时，眼部穿刺装置包括在中空穿刺针6刺破针筒前封闭端之后的结膜下腔导流状态，在结膜下腔导流状态下，中空穿刺针6从针筒前封闭端伸出的长度范围为结膜下腔导流长度范围，在结膜下腔导流长度范围内，优选地，周壁针孔6b位于注射剂容纳区7内。When applied to subconjunctival puncture, the ophthalmic puncture device includes a subconjunctival diversion state after thehollow puncture needle 6 punctures the front closed end of the syringe. The extended length of the front closed end of the barrel is the range of the diversion length of the subconjunctival cavity, and within the range of the diversion length of the subconjunctival cavity, preferably, the peripheralwall needle hole 6b is located in theinjection accommodating area 7 .

对于眼部植入器具总成，其包括的眼部穿刺装置、辅助导向针12和眼部植入件可设置为预先或非预先组装。在使用时，先通过眼部穿刺装置向眼部的组织间隙、腔系、脉管注入眼部注射剂以将其撑大，然后使眼部植入件通过辅助导向针12的针腔和眼部穿刺装置的植入件导向结构导入至中空穿刺针6的针腔内，最后眼部植入件从前端针孔6a伸出以植入至被撑大后的该组织间隙、腔系、脉管。As for the ocular implant device assembly, the ocular piercing device, theauxiliary guide needle 12 and the ocular implant can be provided pre-assembled or not pre-assembled. When in use, the eye injection is first injected into the tissue space, cavity system, and blood vessels of the eye through the eye puncture device to expand it, and then the eye implant is passed through the needle cavity of theauxiliary guide needle 12 and the eye. The implant guide structure of the puncture device is introduced into the needle cavity of thehollow puncture needle 6, and finally the eye implant protrudes from thefront needle hole 6a to be implanted into the expanded tissue gap, cavity system, and vessel .

通常地，眼部植入件呈丝状或管状。例如，前述适用于青光眼引流治疗的引流装置可以设置成管状。Typically, ocular implants are in the form of filaments or tubes. For example, the aforementioned drainage device suitable for drainage treatment of glaucoma may be arranged in a tubular shape.

由前述的青光眼治疗方法可知，通过采用眼部植入器具总成，能够将引流装置的流出端置于脉络膜上腔且将引流装置的流入端置于前房，从而在脉络膜上腔和前房之间提供流体连通。或者，能够将引流装置的流出端置于结膜下腔且将引流装置的流入端置于前房，从而在结膜下腔和前房之间提供流体连通。又或者，引流装置设有位于引流装置的流入端和流出端之间的引流装置分流口，通过采用眼部植入器具总成，能够将引流装置的流入端置于前房，以及将引流装置的流出端置于脉络膜上腔且将引流装置分流口置于巩膜外(例如结膜下腔或结膜外)，以实现双引流效果。From the aforementioned glaucoma treatment method, it can be seen that by using the ocular implant assembly, the outflow end of the drainage device can be placed in the suprachoroidal space and the inflow end of the drainage device can be placed in the anterior chamber, so that the suprachoroidal space and anterior chamber fluid communication is provided. Alternatively, the outflow end of the drainage device can be placed in the subconjunctival space and the inflow end of the drainage device in the anterior chamber, thereby providing fluid communication between the subconjunctival space and the anterior chamber. Or, the drainage device is provided with a drainage device shunt port between the inflow end and the outflow end of the drainage device, and by using the eye implant device assembly, the inflow end of the drainage device can be placed in the anterior chamber, and the drainage device The outflow end of the device is placed in the suprachoroidal space and the shunt port of the drainage device is placed outside the sclera (such as the subconjunctival space or extraconjunctival space) to achieve a double drainage effect.

为便于调节引流装置的流出端的朝向，优选地，采用能够柔性弯折的柔性引流导管作为引流装置，结合前述的方法可知，柔性引流导管尤其适用于双引流的治疗方法。In order to adjust the direction of the outflow end of the drainage device, preferably, a flexible drainage catheter that can be flexibly bent is used as the drainage device. Combining the above methods, it can be seen that the flexible drainage catheter is especially suitable for the treatment method of double drainage.

以上结合附图详细描述了本发明实施例的可选实施方式，但是，本发明实施例并不限于上述实施方式中的具体细节，在本发明实施例的技术构思范围内，可以对本发明实施例的技术方案进行多种简单变型，这些简单变型均属于本发明实施例的保护范围。The optional implementations of the embodiments of the present invention have been described in detail above in conjunction with the accompanying drawings. However, the embodiments of the present invention are not limited to the specific details in the above-mentioned embodiments. Within the scope of the technical concept of the embodiments of the present invention, the embodiments of the present invention can be Various simple modifications are made to the technical solution, and these simple modifications all belong to the protection scope of the embodiments of the present invention.

另外需要说明的是，在上述具体实施方式中所描述的各个具体技术特征，在不矛盾的情况下，可以通过任何合适的方式进行组合，为了避免不必要的重复，本发明实施例对各种可能的组合方式不再另行说明。In addition, it should be noted that the various specific technical features described in the above specific implementation manners can be combined in any suitable way if there is no contradiction. In order to avoid unnecessary repetition, the embodiments of the present Possible combinations are not described separately.

此外，本发明实施例的各种不同的实施方式之间也可以进行任意组合，只要其不违背本发明实施例的思想，其同样应当视为本发明实施例所公开的内容。In addition, various implementations of the embodiments of the present invention can also be combined arbitrarily, as long as they do not violate the idea of the embodiments of the present invention, they should also be regarded as the content disclosed in the embodiments of the present invention.

Claims (14)

1. An ocular implantation instrument assembly, comprising:

the eye puncture device comprises a needle cylinder (1), an elastic pushing assembly, a hollow puncture needle (6), at least one injection accommodating area (7), an eye injection and an implant guiding structure, wherein the elastic pushing assembly comprises a pressing part (2) and a penetrable movable sealing part (3) which is positioned in an inner cavity of the needle cylinder and can be elastically connected with the pressing part (2) in a front-back mode, the hollow puncture needle (6) is fixedly connected to the pressing part (2) and is provided with a front end needle hole (6 a) and a peripheral wall needle hole (6 b), the injection accommodating area (7) is formed in an inner cavity area of the needle cylinder which is formed by enclosing the front closed end of the needle cylinder, the peripheral wall of the inner cavity of the needle cylinder and the movable sealing part (3), and the eye injection is stored in the injection accommodating area (7) in advance;

a secondary guide needle (12) connectable with the implant guide structure; and

an ocular implant which can be introduced into the needle cavity of the hollow puncture needle (6) via the needle cavity of the auxiliary guide needle (12) and the implant guide structure;

the eye puncture device is arranged to push the hollow puncture needle (6) forwards to puncture the front closed end of the needle cylinder by pressing the pressing part (2), so that the eye injection can flow out to the tissue gap, the cavity system and the vessel of the dilated eye from the injection accommodating area (7), the peripheral wall needle hole (6 b) and the front end needle hole (6 a) which are communicated in sequence, and the eye implant led into the needle cavity of the hollow puncture needle (6) can extend out from the front end needle hole (6 a) to be implanted into the tissue gap, the cavity system and the vessel after being dilated.

2. The ocular implant device assembly of claim 1, wherein the ocular implant is in the form of a wire or tube.

3. The ocular implant device assembly of claim 1, wherein the ocular implant comprises a drainage device suitable for glaucoma drainage therapy.

4. The ocular implant device assembly of claim 3, wherein the drainage device is a flexible shunt catheter capable of flexible bending.

5. The ocular implant device assembly of claim 3, wherein the ocular implant device assembly is configured to position the outflow end of the drainage device in the suprachoroidal space and the inflow end of the drainage device in the anterior chamber.

6. The ocular implant instrument assembly of claim 3, wherein the ocular implant instrument assembly is configured to place the outflow end of the drainage device in the subconjunctival cavity and the inflow end of the drainage device in the anterior chamber.

7. The ocular implant device assembly of claim 3, wherein the drainage device is provided with a drainage device shunt port located between an inflow end and an outflow end of the drainage device, the ocular implant device assembly being configured to enable placement of the inflow end of the drainage device in the anterior chamber and the outflow end of the drainage device in the suprachoroidal space and the drainage device shunt port outside the sclera.

8. The ocular implant device assembly of any one of claims 1 to 7, wherein the implant guide structure comprises an inclined guide groove (3 a) formed on the movable seal portion (3) and extending obliquely toward the hollow puncture needle (6), and the auxiliary guide needle (12) can penetrate into the inner cavity of the cylinder from the rear open end of the cylinder and pass through the inclined guide groove (3 a) to penetrate into the peripheral wall needle hole (6 b) located in front of the movable seal portion (3).

9. The ocular implant device assembly of claim 8, wherein the inclined guide groove (3 a) is formed through in the front-rear direction, the implant guide structure further comprises an openable and closable one-way flap member (9) embedded in the inclined guide groove (3 a) or a guide groove seal member inserted into the inclined guide groove (3 a), and the auxiliary guide needle (12) is capable of forwardly opening the one-way flap member (9) or forwardly piercing the guide groove seal member.

10. The eye implanting apparatus assembly of claim 8, wherein the inclined guide groove (3 a) is formed in an upper surface of the movable sealing portion (3) and is a non-through groove, and the auxiliary guide needle (12) can penetrate the inclined guide groove (3 a) forward.

11. The ocular implant device assembly of claim 8, wherein the peripheral wall needle hole (6 b) is formed as an inclined hole opened toward an inclined rear direction, and a front end of the auxiliary guide needle (12) is aligned with the inclined hole when the auxiliary guide needle (12) passes through the inclined guide groove (3 a).

12. The ocular implant device assembly according to any one of claims 1 to 7, wherein the implant guide structure comprises an inclined guide needle hole (6 c) formed in a peripheral wall of the hollow puncture needle (6) and opened obliquely rearward, and the ocular puncture apparatus comprises a flow guide state in which the injection agent housing section (7), the peripheral wall needle hole (6 b) and the front end needle hole (6 a) are communicated, the inclined guide needle hole (6 c) being located rearward of the movable seal portion (3) in the flow guide state, and the auxiliary guide needle (12) being capable of protruding into the cylinder cavity from the cylinder rear open end and penetrating into the inclined guide needle hole (6 c).

13. The ocular implant device assembly of claim 12, wherein the implant guide structure further comprises a one-way valve assembly (9) inserted into the inclined guide needle hole (6 c) and openable and closable or a needle hole sealing member (10) inserted into the inclined guide needle hole (6 c), and the auxiliary guide needle (12) can forwardly open the one-way valve assembly (9) or forwardly pierce the needle hole sealing member (10).

14. The ocular implant device assembly according to any one of claims 1 to 7, wherein the implant guide structure comprises a pierceable middle guide groove (2 c) formed at a middle position of a rear end surface of the pressing portion (2), the hollow puncture needle (6) is formed with a rear needle hole which is axially aligned with the middle guide groove (2 c), and the auxiliary guide needle (12) can pierce the middle guide groove (2 c) forward from the rear open end of the cylinder and penetrate the rear needle hole.

Images