Ocular puncture device and ocular implant device assembly

Abstract

The present invention discloses an ocular puncture device and an ocular implantation instrument assembly. The device comprises a syringe, an elastic push assembly, a hollow puncture needle, at least one injection accommodating area and an ocular injection. The elastic push assembly comprises a pressing portion and a puncturable movable sealing portion which is located in the inner cavity of the syringe and can be elastically connected with the pressing portion in front and back. The hollow puncture needle is fixedly connected to the pressing portion and is formed with a front end needle hole and a peripheral wall needle hole. The injection accommodating area is formed in the inner cavity area of ​​the syringe which is jointly surrounded by the front closed end of the syringe, the inner cavity peripheral wall of the syringe and the movable sealing portion. The ocular injection is pre-stored in the injection accommodating area. By pressing the pressing portion, the hollow puncture needle can be pushed forward to puncture the front closed end of the syringe, so that the ocular injection can flow outward from the injection accommodating area, the peripheral wall needle hole and the front end needle hole which have been connected in sequence. This process has precise control over the puncture depth and has high stability, and is conducive to quantitative injection.

Description

Technical Field

[0001] The present invention relates to the technical field of medical instruments, and in particular to an eye puncture device and an eye implantation instrument assembly. Background Art

[0002] In order to deal with eye diseases (such as glaucoma, suprachoroidal or subconjunctival space diseases, etc.), some existing treatment methods use syringes to inject, probe, dilate or implant instruments into the visible or potential tissue spaces, cavities, and blood vessels of the eye. However, conventional syringes require manual control of the puncture depth during puncture, and rely on the experience of medical staff to determine whether the needle has penetrated the target area in the eye. In addition, the eye structures of different patients are usually different, and the proficiency of different medical staff varies, so the accuracy of puncture cannot be effectively guaranteed. In addition, during the injection process, it is necessary to continuously apply pressure to push the syringe plunger, and this process usually cannot ensure a stable injection speed. Summary of the invention

[0003] In view of the above-mentioned defects or shortcomings of the prior art, the present invention provides an eye puncture device and an eye implant instrument assembly, which can realize the injection, penetration, expansion or instrument implantation of the obvious or potential tissue gaps, cavities, and blood vessels of the eye, and the control of the puncture depth and injection volume is precise and stable.

[0004] To achieve the above-mentioned object, the first aspect of the present invention provides an ocular puncture device, the ocular puncture device comprising a syringe, an elastic push assembly, a hollow puncture needle, at least one injection containing area and an ocular injection suitable for ocular injection, the syringe comprising a syringe front closed end and a syringe rear open end, the elastic push assembly comprising a pressing portion and a puncturable movable sealing portion located in the syringe inner cavity and capable of forming a front-to-back elastic connection with the pressing portion, the hollow puncture needle is fixedly connected to the pressing portion and is formed with a front needle hole and a peripheral wall needle hole, the injection containing area is formed in the syringe inner cavity area surrounded by the syringe front closed end, the syringe inner cavity peripheral wall and the movable sealing portion, and the ocular injection is pre-stored in the injection containing area;

[0005] Wherein, the eye puncture device is configured to be able to push the hollow puncture needle forward to puncture the front closed end of the syringe by pressing the pressing part, so that the eye injection can flow out from the injection containing area, the peripheral wall needle hole and the front end needle hole which have been connected in sequence.

[0006] Optionally, the ocular injection comprises an ocular therapeutic agent for treating ocular diseases; and / or, the ocular injection comprises a shapeable ocular injection that can be shaped after being injected into and expanding the apparent or potential tissue spaces, cavities, and vessels of the eye.

[0007] Optionally, the specification of the hollow puncture needle is 30G to 23G.

[0008] Optionally, the ocular puncture device comprises a first type ocular implant pre-installed in the needle cavity of the hollow puncture needle and capable of advancing to be released from the front needle hole;

[0009] and / or, the ocular puncture device comprises a second type of ocular implant which is sleeved outside the hollow puncture needle and can be advanced to be released from the front end of the hollow puncture needle;

[0010] And / or, the ocular puncture device includes a third type ocular implant releasably connected to the front end of the hollow puncture needle.

[0011] Optionally, the first type of ocular implant, the second type of ocular implant and the third type of ocular implant each comprise a drainage device suitable for glaucoma drainage treatment.

[0012] Optionally, the eye puncture device includes a scleral puncture state after the hollow puncture needle punctures the front closed end of the syringe. In the scleral puncture state, the length range of the hollow puncture needle extending from the front closed end of the syringe is the scleral puncture length range. Within the scleral puncture length range, the peripheral wall needle hole is at least partially connected to the injection holding area.

[0013] Optionally, the eye puncture device includes a suprachoroidal space diversion state after the hollow puncture needle punctures the front closed end of the syringe. In the suprachoroidal space diversion state, the length range of the hollow puncture needle extending from the front closed end of the syringe is the suprachoroidal space diversion length range. Within the suprachoroidal space diversion length range, the peripheral wall needle hole is located within the injection holding area.

[0014] Optionally, the eye puncture device includes a subconjunctival space diversion state after the hollow puncture needle punctures the front closed end of the syringe. In the subconjunctival space diversion state, the length range of the hollow puncture needle extending from the front closed end of the syringe is the subconjunctival space diversion length range. Within the subconjunctival space diversion length range, the peripheral wall needle hole is located within the injection holding area.

[0015] Optionally, before the hollow puncture needle extends from the front closed end of the syringe, the needle hole in the peripheral wall is maintained above the injection containing area.

[0016] Optionally, the eye puncture device includes a diversion state that connects the injection holding area, the peripheral wall needle hole and the front end needle hole. In the diversion state, the movable sealing part can move forward to block the peripheral wall needle hole under the action of the rebound force between the pressing part.

[0017] Optionally, in the flow-guiding state, the movable sealing portion blocks the needle hole in the peripheral wall when it moves forward to abut against the front closed end of the syringe.

[0018] Optionally, an axial limiting portion is provided in the inner cavity of the syringe, which is located in front of the movable sealing portion and is used to limit the forward movement of the movable sealing portion. The eye puncture device includes a diversion state that connects the injection containing area, the peripheral wall needle hole and the front end needle hole. In the diversion state, the peripheral wall needle hole is located in front of the axial limiting portion, and the movable sealing portion can move forward under the action of the rebound force between the movable sealing portion and the pressing portion.

[0019] Optionally, the eye puncture device includes a manual control portion connected to the movable sealing portion and partially extending out of the syringe.

[0020] Optionally, the movable sealing portion and the manual control portion form a front-to-rear elastic connection.

[0021] Optionally, the syringe is formed with a syringe circumferential wall groove extending axially on the circumferential wall portion located behind the movable sealing portion, the manual control portion includes a pressure control slider slidingly matched with the syringe circumferential wall groove, and the movable sealing portion and the pressure control slider form a front-to-back elastic connection.

[0022] Optionally, the eye puncture device includes at least one puncturable isolation seal portion which is arranged in the inner cavity area of ​​the syringe between the movable seal portion and the front closed end of the syringe and can slide axially, and the injection containing area is formed with a plurality of axially isolated ones of the isolation seal portions.

[0023] Optionally, the ocular puncture device further comprises an implant guide structure for guiding the ocular implant into the needle cavity of the hollow puncture needle.

[0024] Optionally, the implant guide structure includes an inclined guide groove formed on the movable sealing portion and extending obliquely toward the hollow puncture needle.

[0025] Optionally, the inclined guide groove is arranged to penetrate along the front-to-back direction, and the implant guide structure further includes a one-way valve component embedded in the inclined guide groove and capable of opening and closing, or a guide groove seal inserted in the inclined guide groove.

[0026] Optionally, the inclined guide groove is formed on the upper surface of the movable sealing portion and is a non-through groove.

[0027] Optionally, the peripheral wall pinhole is formed as an inclined hole opening obliquely toward the rear.

[0028] Optionally, the implant guide structure includes an inclined guide needle hole formed on the peripheral wall of the hollow puncture needle and opening obliquely to the rear, and the eye puncture device includes a diversion state that connects the injection holding area, the peripheral wall needle hole and the front end needle hole, and in the diversion state, the inclined guide needle hole is located behind the movable sealing part.

[0029] Optionally, the implant guide structure further includes a one-way valve component embedded in the inclined guide pinhole and capable of opening and closing, or a pinhole seal inserted in the inclined guide pinhole.

[0030] Optionally, the implant guide structure includes a puncturable middle guide groove formed in the middle of the rear end surface of the pressing portion, and the hollow puncture needle is formed with a rear end needle hole, which is axially aligned with the middle guide groove.

[0031] Optionally, the eye puncturing device comprises a puncture control module and a fluid storage module which are independently processed and formed;

[0032] Wherein, the puncture control module comprises a first syringe unit, and the elastic push assembly and the hollow puncture needle arranged in the barrel cavity of the first syringe unit;

[0033] The fluid storage module comprises a second syringe unit, the injection containing area formed in the barrel cavity of the second syringe unit, and a module packaging member detachably packaged at the rear end of the second syringe unit;

[0034] A detachable connection structure is formed between the first syringe unit and the second syringe unit.

[0035] Optionally, the eye puncturing device comprises a puncture control module and a fluid storage module which are independently processed and formed;

[0036] Wherein, the puncture control module includes a first syringe unit and the pressing portion and the hollow puncture needle arranged in the barrel cavity of the first syringe unit;

[0037] The fluid storage module includes a second syringe unit, the injection containing area formed in the barrel cavity of the second syringe unit, and the movable sealing part encapsulated at the rear end of the second syringe unit;

[0038] A detachable connection structure is formed between the first syringe unit and the second syringe unit.

[0039] Optionally, the eye puncture device comprises a puncture control module, a transition connection module and a fluid storage module which are independently processed and formed;

[0040] Wherein, the puncture control module includes a first syringe unit and the pressing portion and the hollow puncture needle arranged in the barrel cavity of the first syringe unit;

[0041] The transition connection module includes a second syringe unit and the movable sealing portion disposed in the barrel cavity of the second syringe unit;

[0042] The fluid storage module includes a third syringe unit, the injection containing area formed in the barrel cavity of the third syringe unit, and a module packaging member detachably packaged at the rear end of the third syringe unit;

[0043] The first syringe unit, the second syringe unit and the third syringe unit are detachably connected in sequence.

[0044] A second aspect of the present invention provides an ocular implant device assembly, which comprises an ocular implant and the above-mentioned ocular puncture device.

[0045] When puncturing with the eye puncture device of the present invention, pressure is first applied to the pressing part to drive the hollow puncture needle to puncture the front closed end of the syringe. When the hollow puncture needle penetrates into the visible or potential tissue gap, cavity system, or blood vessel and the peripheral wall needle hole is located in the injection containing area, the injection containing area, the peripheral wall needle hole, and the front end needle hole are connected. Through reasonable design, the pressure of the eye injection in the injection containing area can be made greater than the pressure in the visible or potential tissue gap, cavity system, or blood vessel. In the case of a pressure difference, the eye injection can flow into the visible or potential tissue gap, cavity system, or blood vessel through the peripheral wall needle hole and the front end needle hole in sequence.

[0046] During the injection process, since the movable sealing part and the pressing part are elastically connected front and back, it is only necessary to keep pressing the pressing part without further increasing the pressing force. Under the action of the rebound force between the movable sealing part and the pressing part, the ocular injection can continue to flow into the pinhole of the peripheral wall, thereby achieving injection, penetration, and expansion of the visible or potential tissue gaps, cavities, and blood vessels. In addition, the ocular implant device assembly of the present invention can also be used to implant medical devices such as ocular implants using an ocular puncture device provided with an implant guide structure.

[0047] In particular, before the hollow puncture needle penetrates into the visible or potential tissue gap, cavity system, or blood vessel, the external pressure on the front needle hole is greater than the pressure of the ocular injection in the injection containing area, so the ocular injection cannot flow out of the front needle hole. Therefore, by observing whether the movable sealing part moves forward under the action of the rebound force between the movable sealing part and the pressing part, it can be judged whether the hollow puncture needle has penetrated into the visible or potential tissue gap, cavity system, or blood vessel, thereby reminding the operator of the current puncture depth and ensuring accurate control of the puncture depth. Since the injection is controlled by the pressure change in the injection containing area, the injection process does not need to increase the thrust applied artificially, which can prevent the fluid from slowing down or rushing up, and ensure stable injection.

[0048] Other features and advantages of the present invention will be described in detail in the following detailed description. BRIEF DESCRIPTION OF THE DRAWINGS

[0049] The accompanying drawings are used to provide a further understanding of the present invention and constitute a part of the specification. Together with the following specific embodiments, they are used to explain the present invention but do not constitute a limitation of the present invention. In the accompanying drawings:

[0050] Figures 1 to 5 It is a schematic diagram of a medical puncture device in a specific embodiment of the present invention in different states during puncture and injection of tissue spaces, cavities, and vessels of an animal;

[0051] Figures 6 to 10 It is a schematic diagram of another medical puncture device in a specific embodiment of the present invention in different states during the puncture and injection process of the tissue space, cavity system, and blood vessel of an animal;

[0052] Figures 11 to 13 It is a schematic diagram of the partial structure of a medical puncture device provided with multiple injection containing areas in different states in a specific embodiment of the present invention;

[0053] Figures 14 to 16 It is a schematic diagram of the partial structure of another medical puncture device provided with multiple injection containing areas in a specific embodiment of the present invention in different states;

[0054] Fig.17 It is a partial structural schematic diagram of a medical puncture device provided with a through inclined guide groove and a one-way flap assembly in a specific embodiment of the present invention;

[0055] Fig.18 To adopt Fig.17 A schematic diagram of a partial structure of a medical device assembly of a medical puncture device;

[0056] Fig.19 It is a partial structural schematic diagram of a medical puncture device provided with a non-through inclined guide groove in a specific embodiment of the present invention;

[0057] Fig. 20 It is a partial structural schematic diagram of a medical puncture device provided with an inclined guide needle hole and a one-way flap assembly in a specific embodiment of the present invention;

[0058] Fig.21 It is a partial structural schematic diagram of a medical puncture device provided with an inclined guide needle hole and a needle hole sealing member in a specific embodiment of the present invention;

[0059] Fig. 22 A schematic diagram of inserting an implant into an animal's tissue gap, cavity system, or blood vessel using a medical device assembly provided with a middle guide groove in a specific embodiment of the present invention;

[0060] Figure 23 to Figure 29 A method for implanting a drainage device into an eye in a specific embodiment of the present invention;

[0061] Figure 30 to Figure 36 Another method for implanting a drainage device into an eye in a specific embodiment of the present invention, the method requires cutting the conjunctiva;

[0062] Figures 37 to 42 Another method for implanting a drainage device into an eye in a specific embodiment of the present invention, the method does not require incision of the conjunctiva;

[0063] Figure 43 to Figure 45 A schematic diagram of an injection step in a method for implanting a drainage device into an eye from an internal route using the medical puncture device (or medical device assembly) of the present invention in a specific embodiment of the present invention;

[0064] Figure 46 to Figure 49 It is a schematic diagram of another medical puncture device in a specific embodiment of the present invention in different states during the puncture and injection process of the tissue gap, cavity system, and blood vessel of an animal.

[0065] Description of reference numerals:

[0066] 1 Syringe 2 Pressing part

[0067] 3 Movable sealing part 4 Elastic sheath

[0068] 5(5') Spring 6 Hollow Puncture Needle

[0069] 7 Injection receiving area 8 Front seal

[0070] 9 One-way valve assembly 10 Pinhole seal

[0071] 11 Implant 12 Auxiliary guide pin

[0072] 13 Isolation seal 14 Conjunctiva

[0073] 15 Subconjunctival space 16 Sclera

[0074] 17 Choroid 18 Suprachoroidal space

[0075] 19 Cornea 20 Anterior chamber

[0076] 21 Pressurized control slider

[0077] 1a Axial limiter 2c Middle guide groove

[0078] 3a Inclined guide groove 6a Front pinhole

[0079] 6b Peripheral wall pinhole 6c Inclined guide pinhole

[0080] 7a Front injection storage area 7b Rear injection storage area

[0081] 6b1 front wall pinhole 6b2 rear wall pinhole DETAILED DESCRIPTION

[0082] The specific implementation of the embodiment of the present invention is described in detail below in conjunction with the accompanying drawings. It should be understood that the specific implementation described here is only used to illustrate and explain the embodiment of the present invention, and is not used to limit the embodiment of the present invention.

[0083] It should be noted that, in the absence of conflict, the embodiments of the present invention and the features in the embodiments may be combined with each other.

[0084] In the embodiments of the present invention, the directional words "front, back, forward, backward, front end, rear end" and the like used are all based on the perspective of an operator (e.g., a surgeon, a physician, a nurse, a technician, etc.) using the medical puncture device or the medical instrument assembly of the present invention, that is, when the operator uses the medical puncture device or the medical instrument assembly, the direction relatively away from the operator is the forward direction, and the direction relatively close to the operator is the backward direction.

[0085] The present invention will be described in detail below in conjunction with exemplary embodiments with reference to the accompanying drawings.

[0086] like Figures 1 to 22 As shown, the first exemplary embodiment of the present invention provides a medical puncture device, which includes a syringe 1, an elastic push component, a hollow puncture needle 6 and at least one injection containing area 7.

[0087] Among them, the syringe 1 includes a closed front end and an open rear end. When it is commercialized, the syringe 1 can be designed as a structure with openings at both ends along the axial direction. A front end seal 8 is provided at the front end opening of the syringe 1 to achieve sealing. The front end seal 8 needs to be made of rubber or other materials that can be pierced by the hollow puncture needle 6.

[0088] The elastic push assembly includes a pressing portion 2 and a movable sealing portion 3. The movable sealing portion 3 is located in the inner cavity of the syringe and can move axially. The pressing portion 2 usually at least partially extends out of the rear opening end of the syringe for the operator to manually press. By applying pressure to the pressing portion 2, the movable sealing portion 3 and the pressing portion 2 can form a front-to-back elastic connection. At this time, if the position of the pressing portion 2 is kept unchanged, the movable sealing portion 3 has a tendency to move forward under the action of the rebound force between the pressing portion 2 and the pressing portion 2.

[0089] In addition, the pressing part 2 may also include a portion extending into the inner cavity of the syringe, and the portion may define a closed area together with the inner cavity wall of the syringe and the movable sealing part 3, that is, a closed area may be formed behind the movable sealing part 3, and the closed area may contain a flowing or non-flowing medium, such as disinfectant gas, etc. Alternatively, the portion of the pressing part 2 extending into the inner cavity of the syringe may also define a non-closed area together with the inner cavity wall of the syringe and the movable sealing part 3, that is, a non-closed area may be formed behind the movable sealing part 3 for connecting to the external environment.

[0090] The hollow puncture needle 6 is fixedly connected to the pressing part 2. When no pressure is applied to the pressing part 2, the hollow puncture needle 6 will not move forward to puncture the front closed end of the syringe, but it is not limited to the state that the hollow puncture needle 6 has punctured the front closed end of the syringe when the product leaves the factory. As for the hollow puncture needle 6 itself, it is formed with a front needle hole 6a and a peripheral wall needle hole 6b, and the front needle hole 6a and the peripheral wall needle hole 6b are connected through the needle cavity of the hollow puncture needle 6.

[0091] The injection storage area 7 is used to store injections. The 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 the injection storage area 7 or in the form of a mixture. The injections preferably use liquids (such as solutions, suspensions, etc.) or semisolid compositions (such as gels) that are easy to manipulate, and preferably can be shaped after being injected and expanded into tissue gaps, cavities, and blood vessels. For example, the injection can be performed at or near the target site, and the injection will then solidify and take shape, and can have a higher strength to maintain the expanded tissue gaps, cavities, and blood vessels.

[0092] Injection can have fluidity, including preparations with low viscosity, high viscosity or viscosity similar to water, such as pasty materials. The fluidity of the preparation can make it conform to the irregularities, gaps, cracks and / or spaces of the tissue site. For example, the preparation can be used to fill one or more spaces, expand tissue spaces (e.g., visible tissue spaces) and / or form potential tissue spaces into visible tissue spaces, and optionally expand the spaces produced. In addition, when contacting with aqueous media (e.g., body fluids, water, etc.), some injections can also harden to form a drug warehouse that is convenient for controlling drug release.

[0093] The injection containing area 7 is formed in the syringe inner cavity area surrounded by the front closed end of the syringe, the inner cavity peripheral wall of the syringe and the movable sealing part 3. Since the movable sealing part 3 can move axially during the injection process, the injection containing area 7 has a variable volume, so that the injection pressure in the injection containing area 7 can change with the axial movement of the movable sealing part 3.

[0094] When puncturing with the medical puncture device of the exemplary embodiment, by applying pressure to the pressing part 2, the hollow puncture needle 6 can be pushed forward to puncture the front closed end of the syringe, and when the hollow puncture needle 6 penetrates the visible or potential tissue gap, cavity system, and blood vessel, and the peripheral wall needle hole 6b is located in the injection accommodating area 7, the injection accommodating area 7, the peripheral wall needle hole 6b, and the front end needle hole 6a are connected. Through reasonable design, the injection pressure in the injection accommodating area 7 can be made greater than the pressure in the visible or potential tissue gap, cavity system, and blood vessel. In the case of a pressure difference, the injection can flow into the visible or potential tissue gap, cavity system, and blood vessel through the peripheral wall needle hole 6b and the front end needle hole 6a in sequence.

[0095] During the above injection process, since the movable sealing part 3 and the pressing part 2 maintain elastic connection front and back, it is only necessary to keep pressing the pressing part 2 without further increasing the pressing force. Under the action of the rebound force between the movable sealing part 3 and the pressing part 2, the injection can continue to flow into the needle hole 6b in the peripheral wall, thereby realizing the injection, penetration and expansion of the obvious or potential tissue gaps, cavities and blood vessels.

[0096] Before the hollow puncture needle 6 penetrates into the visible or potential tissue gap, cavity system, or blood vessel, the external pressure on the front needle hole 6a is greater than the injection pressure in the injection containing area 7, so the injection cannot flow out from the front needle hole 6a. For example, taking the puncture process of the suprachoroidal space of the eye as an example, when the hollow puncture needle 6 pierces the sclera but has not yet penetrated the suprachoroidal space, regardless of whether the peripheral wall needle hole 6b is connected to the injection containing area 7, the injection will not flow out from the front needle hole 6a. This is because the sclera is relatively dense. When the front needle hole 6a is located in the sclera, it is equivalent to forming a larger external pressure at the front needle hole 6a. The external pressure is greater than the injection pressure in the injection containing area 7, so that the injection cannot flow out.

[0097] Therefore, by observing whether the movable sealing part 3 moves forward under the action of the rebound force between the movable sealing part 3 and the pressing part 2, it can be judged whether the hollow puncture needle 6 has penetrated into the visible or potential tissue gap, cavity system, or blood vessel, thereby reminding the operator of the current puncture depth and ensuring accurate control of the puncture depth. Since the injection is controlled by the injection pressure change in the injection containing area 7, the injection process does not need to increase the thrust applied artificially, which can prevent the injection from being slow or fast, and ensure stable injection.

[0098] In some embodiments, the medical puncture device further includes at least one puncturable isolation seal 13 disposed in the inner cavity area of ​​the syringe between the movable seal 3 and the front closed end of the syringe and capable of sliding in the axial direction. Under this structure, a plurality of injection accommodating areas 7 are formed, and the plurality of injection accommodating areas 7 are sequentially isolated and arranged in the axial direction under the action of the isolation seal 13. The plurality of injection accommodating areas 7 can store the same injection or different injections.

[0099] For example, refer to Figures 11 to 16 The injection containing area 7 includes a front injection containing area 7a and a rear injection containing area 7b which are isolated from each other.

[0100] exist Figures 11 to 13 In the embodiment shown, the peripheral wall needle hole 6b includes a front peripheral wall needle hole and a rear peripheral wall needle hole arranged at intervals in front and back. Under this structure, if the hollow puncture needle 6 is first punctured until the front peripheral wall needle hole is connected to the front injection storage area 7a and the rear peripheral wall needle hole is surrounded and sealed by the isolation sealing part 13, the injection in the front injection storage area 7a will first flow into the visible or potential tissue gap, cavity system, and blood vessel through the front peripheral wall needle hole and the front end needle hole 6a in sequence, and under the action of the rebound force between the movable sealing part 3 and the pressing part 2, the injection amount in the front injection storage area 7a is continuously reduced, and the movable sealing part 3 and the isolation sealing part 13 are continuously moved forward. Through reasonable design, the rear peripheral wall needle hole can be connected with the rear injection storage area 7b before the isolation sealing part 13 blocks the front peripheral wall needle hole, so that the injection in the rear injection storage area 7b flows into the visible or potential tissue gap, cavity system, and blood vessel through the rear peripheral wall needle hole and the front end needle hole 6a in sequence. Therefore, in this embodiment, the injection in the front injection accommodating area 7a and the rear injection accommodating area 7b can be injected into the manifest or potential tissue gaps, cavities, and blood vessels in sequence.

[0101] exist Figures 11 to 13 In another embodiment shown, the hollow puncture needle 6 can also be punctured so that the needle hole in the front peripheral wall is connected to the front injection accommodating area 7a and the needle hole in the rear peripheral wall is connected to the rear injection accommodating area 7b, so that the injection in the front injection accommodating area 7a and the rear injection accommodating area 7b can be mixed and then injected into the obvious or potential tissue gaps, cavities, and blood vessels.

[0102] exist Figures 14 to 16 In the embodiment shown, only one peripheral wall needle hole 6b is provided. Through reasonable design, the hollow puncture needle 6 can be punctured until the front of the peripheral wall needle hole 6b is connected with the front injection containing area 7a and the rear of the peripheral wall needle hole 6b is surrounded and sealed by the isolation sealing part 13. At this time, the injection in the front injection containing area 7a will first flow into the visible or potential tissue gap, cavity system, and blood vessel through the front of the peripheral wall needle hole 6b and the front end needle hole 6a in sequence. Under the action of the rebound force between the movable sealing part 3 and the pressing part 2, the injection amount in the front injection containing area 7a is continuously reduced, and the movable sealing part 3 and the isolation sealing part 13 are continuously moved forward. Similarly, through reasonable design, before the isolation sealing part 13 blocks the front of the front peripheral wall needle hole, the rear of the peripheral wall needle hole 6b can be connected with the rear injection containing area 7b, so that the injection in the rear injection containing area 7b flows into the visible or potential tissue gap, cavity system, and blood vessel through the rear of the peripheral wall needle hole 6b and the front end needle hole 6a in sequence. Therefore, in this embodiment, it is also possible to inject the injection in the front injection containing area 7a and the rear injection containing area 7b into the manifest or potential tissue gaps, cavities, and blood vessels in sequence.

[0103] exist Figures 14 to 16 In another embodiment shown, the hollow puncture needle 6 can also be punctured so that the front part of the peripheral wall needle hole 6b is connected with the front injection agent accommodating area 7a, the rear part of the peripheral wall needle hole 6b is connected with the rear injection agent accommodating area 7b, and the part between the front and rear parts of the peripheral wall needle hole 6b is surrounded and sealed by the isolation sealing part 13, so that the injection in the front injection agent accommodating area 7a and the rear injection agent accommodating area 7b can be mixed and then injected into the obvious or potential tissue gaps, cavities, and blood vessels.

[0104] It should be noted that the explicit or potential tissue spaces, cavities, and blood vessels mentioned in this article may be the suprachoroidal space, epidural space, pleural cavity, peritoneal cavity, joint cavity, artery, vein, etc., without specific limitation. Therefore, the medical puncture device of this exemplary embodiment also has the advantage of strong versatility.

[0105] After the medical puncture device of this exemplary embodiment leaves the factory and before it is used, the specific position of the hollow puncture needle 6 may be slightly different, that is, the medical puncture device may be set in a variety of factory configurations.

[0106] For example, the hollow puncture needle 6 has pierced the movable sealing part 3 but has not pierced the front closed end of the syringe. At this time, the peripheral wall needle hole 6b can be located behind the movable sealing part 3, surrounded and sealed by the movable sealing part 3, or connected to the injection containing area 7, and the front end needle hole 6a can be connected to the injection containing area 7 or surrounded and sealed by the front closed end of the syringe.

[0107] Alternatively, the hollow puncture needle 6 has pierced the movable sealing part 3 and the front closed end of the syringe. At this time, the peripheral wall needle hole 6b can be located behind the movable sealing part 3, surrounded and sealed by the movable sealing part 3, or connected to the injection containing area 7, and the front end needle hole 6a is located outside the front closed end of the syringe.

[0108] Alternatively, the hollow puncture needle 6 does not pierce the movable sealing part 3, that is, the entirety is located behind the movable sealing part 3. Accordingly, the peripheral wall needle hole 6b and the front end needle hole 6a are both located behind the movable sealing part 3.

[0109] It can be seen that as long as the needle hole 6b in the peripheral wall and the injection containing area 7 are not connected to each other when the product leaves the factory, no matter whether the hollow puncture needle 6 pierces the movable sealing part 3 and the front closed end of the syringe, and whether the front end needle hole 6a is located outside the front closed end of the syringe, the possibility of the injection leaking from the front end needle hole 6a before puncture can be eliminated.

[0110] In fact, from the above, it can be seen that if through reasonable design, the external pressure to which the front end needle hole 6a is subjected before connecting with the obvious or potential tissue gap, cavity system, or blood vessel is greater than the injection pressure in the injection containing area 7, then even if the peripheral wall needle hole 6b is connected with the injection containing area 7 when the product leaves the factory, the injection will not leak out prematurely from the front end needle hole 6a.

[0111] In addition, for the possible backflow of injection when the peripheral wall needle hole 6b is located behind the movable sealing part 3 and the front end needle hole 6a is located in the injection containing area 7, corresponding embodiments will be provided as remedial measures later, so they will not be described in detail here.

[0112] Among the different product forms, a more preferred one is that the hollow puncture needle 6 does not puncture the movable sealing part 3 when the product leaves the factory, that is, the hollow puncture needle 6 is located entirely behind the movable sealing part 3. When using the medical puncture device with this factory form for puncture, the pressing part 2 can be pressed to drive the hollow puncture needle 6 forward to puncture the movable sealing part 3 and the front closed end of the syringe in sequence until the front needle hole 6a enters the visible or potential tissue gap, cavity system, and blood vessel, and the peripheral wall needle hole 6b is connected to the injection containing area 7.

[0113] To ensure that the hollow puncture needle 6 can eventually puncture the front closed end of the syringe, a puncture guide structure such as a guide groove, a guide blind hole or a guide slit for guiding the hollow puncture needle 6 to puncture can be provided on the rear end surface of the movable sealing portion 3.

[0114] After the hollow puncture needle 6 punctures the front closed end of the syringe, the medical puncture device includes at least two different states, namely, the surface tissue puncture state and the diversion state.

[0115] In the surface tissue puncture state, the length range of the hollow puncture needle 6 extending from the front closed end of the syringe is the surface tissue puncture length range. Within this range, the front end of the hollow puncture needle 6 penetrates into the surface tissue but has not yet penetrated into the obvious or potential tissue gaps, cavities, and blood vessels. Since the surface tissue is relatively dense, the external pressure at the front end needle hole 6a is greater than the injection pressure in the injection holding area 7. Therefore, regardless of whether the peripheral wall needle hole 6b is connected to the injection holding area 7, the injection cannot flow out.

[0116] In the diversion state, the length range of the hollow puncture needle 6 extending from the front closed end of the syringe is the diversion length range, within which the hollow puncture needle 6 has penetrated into the visible or potential tissue gap, cavity system, and blood vessel. As mentioned above, reasonable design can be used to ensure that the injection pressure in the injection containing area 7 is greater than the pressure in the visible or potential tissue gap, cavity system, and blood vessel. When the peripheral wall needle hole 6b is connected to the injection containing area 7, in the case of an internal and external pressure difference, the injection in the injection containing area 7 can flow into the visible or potential tissue gap, cavity system, and blood vessel through the peripheral wall needle hole 6b and the front end needle hole 6a in sequence.

[0117] Various optional embodiments for controlling the stopping of the injection action of the medical puncture device are described below.

[0118] In one embodiment, when the medical puncture device is in the diversion state, the movable sealing part 3 can move forward to block the peripheral wall needle hole 6b under the action of the rebound force between the movable sealing part 3 and the pressing part 2, and the injection action stops immediately after the peripheral wall needle hole 6b is blocked. It can be seen that the axial position of the peripheral wall needle hole 6b in the injection containing area 8 limits the maximum injection volume of the medical puncture device.

[0119] For example, when the injection containing area 7 needs to be emptied, the movable sealing part 3 can be limited to block the peripheral wall pinhole 6b when it moves forward to abut the front closed end of the syringe, so at this time the peripheral wall pinhole 6b is located at the front end of the injection containing area 7. However, in fact, as the injection in the injection containing area 7 gradually flows into the apparent or potential tissue gap, cavity system, and blood vessel, there will be a state where the injection pressure in the injection containing area 7 is the same as the pressure in the apparent or potential tissue gap, cavity system, and blood vessel, and at this time the movable sealing part 3 will no longer move due to the force balance. If the injection containing area 7 is to be emptied, the forward thrust applied to the movable sealing part 3 needs to be increased.

[0120] For example, refer to Figures 6 to 10In the embodiment shown, a slide groove (not shown) extending in the axial direction may be provided on the peripheral wall of the syringe 1, and a slider matching the slide groove may be provided on the pressing portion 2 (i.e., the portion of the pressing portion 2 extending outside the syringe 1), so that the upper limit of the pressing movement stroke of the pressing portion 2 is larger. When the movable sealing portion 3 no longer moves due to force balance, a greater pressing force may be applied to the slider of the pressing portion 2 to drive the pressing portion 2 to continue to move forward, thereby increasing the rebound force between the movable sealing portion 3 and the pressing portion 2, breaking the force balance state of the movable sealing portion 3, and causing the movable sealing portion 3 to continue to move forward. In this way, the injection containing area 7 can discharge more fluid or even empty it.

[0121] Alternatively, the movable sealing portion 3 may be further pushed to abut against the front closed end of the syringe by means of other driving structures. An optional driving structure will be described in the following embodiment.

[0122] In another embodiment, the medical puncture device includes a manual control part, which is connected to the movable sealing part 3 and partially extends out of the syringe. For example, the movable sealing part 3 can form a front-to-back elastic connection with the manual control part, or the manual control part can also be directly fixedly connected to the movable sealing part 3, but it is obvious that in the case of forming an elastic connection, it is more conducive to maintaining a stable injection speed.

[0123] When the injection dose injected into the visible or potential tissue gap, cavity system, or blood vessel does not reach the original target, and the movable sealing part 3 does not move due to force balance, the operator can drive the movable sealing part 3 to continue to move forward by controlling the part of the manual control part extending outside the syringe until the injection dose discharged outside reaches the original target. The solution in this embodiment can solve the problem that the injection containing area 7 cannot be emptied in the previous embodiment. Of course, this embodiment is not limited to the case where the injection containing area 7 is to be emptied.

[0124] Reference Figure 46 to Figure 49 , a syringe circumferential wall groove extending in the axial direction can be provided on the circumferential wall portion of the syringe 1 behind the movable sealing portion 3. In this case, the manual control portion includes a pressure control slider 21 that slides with the syringe circumferential wall groove. The pressure control slider 21 extends out of the syringe 1 through the syringe circumferential wall groove portion, which is convenient for user control, and the movable sealing portion 3 and the pressure control slider 21 form a front-to-back elastic connection. For example, a spring 5' as shown in the figure is provided between the movable sealing portion 3 and the pressure control slider 21. Under this structure, by further applying pressure on the pressure control slider 21 to make it slide forward along the axial direction of the syringe circumferential wall groove, the movable sealing portion 3 and the pressure control slider 21 can be elastically compressed. When the position of the pressure control slider is maintained, under the action of the rebound force, the movable sealing portion 3 can break the force balance state and continue to move forward until the external injection dose reaches the original target.

[0125] In another embodiment, the medical puncture device can achieve quantitative injection of the injection. Figures 1 to 10 An axial limiting portion 1a is provided in the inner cavity of the syringe, which is located in front of the movable sealing portion 3 and is used to limit the movable sealing portion 3 from moving forward. When the medical puncture device is in the diversion state, the needle hole 6b in the peripheral wall is located in front of the axial limiting portion 1a, and the movable sealing portion 3 can move forward under the action of the rebound force between the pressing portion 2.

[0126] There are two situations in which the movable sealing part 3 is moved to the position limited by the axial limiting part 1a:

[0127] The first situation is that until the movable sealing part 3 moves to the position limited by the axial limiting part 1a, the injection pressure in the injection containing area 7 is still not less than the pressure in the apparent or potential tissue gaps, cavities, and blood vessels. In other words, at this time, only the rebound force between the movable sealing part 3 and the pressing part 2 can push the movable sealing part 3 forward to the position limited by the axial limiting part 1a without the need for other driving structures.

[0128] The second situation is that before the movable sealing part 3 is pushed to abut against the axial limiting part 1a by the rebound force between the movable sealing part 3 and the pressing part 2, the injection pressure in the injection containing area 7 is the same as the pressure in the apparent or potential tissue gap, cavity system, and blood vessel (that is, the movable sealing part 3 no longer moves due to force balance). At this time, the movable sealing part 3 cannot be pushed to the position limited by the axial limiting part 1a by relying solely on the rebound force between the movable sealing part 3 and the pressing part 2. Therefore, the movable sealing part 3 needs to be further pushed forward by an additional driving structure. For example, the driving structure can be the aforementioned manual control part. However, no matter which situation it belongs to, the axial limiting part 1a set in this embodiment is the basis for realizing the quantitative injection of the injection.

[0129] The following describes various different puncture and injection opportunities of the medical puncture device.

[0130] In one embodiment, before the hollow puncture needle 6 extends from the front closed end of the syringe, the needle hole 6b of the peripheral wall is always maintained above the injection containing area 7. This arrangement can prevent the phenomenon of premature leakage at the front needle hole 6a and improve the reliability of the medical puncture device.

[0131] In another embodiment, when the medical puncture device is in the state of surface tissue puncture, that is, when the length of the hollow puncture needle 6 extending from the front closed end of the syringe is within the range of the surface tissue puncture length (or when the front end of the hollow puncture needle 6 penetrates into the surface tissue but has not penetrated into the visible or potential tissue gap, cavity system, or blood vessel), the peripheral wall needle hole 6b is at least partially connected to the injection containing area 7. In other words, before the front end of the hollow puncture needle 6 penetrates into the visible or potential tissue gap, cavity system, or blood vessel, the injection containing area 7, the peripheral wall needle hole 6b, and the front end needle hole 6a are connected in advance, so that the injection is injected into the needle cavity of the hollow puncture needle 6 in advance, at least a part of the air is discharged, and the amount of air entering the visible or potential tissue gap, cavity system, or blood vessel is reduced.

[0132] More preferably, when the front end of the hollow puncture needle 6 begins to penetrate into the surface tissue, the needle hole 6b of the peripheral wall begins to connect to the injection containing area 7. Then, when the front end of the hollow puncture needle 6 penetrates into the visible or potential tissue gaps, cavities, and blood vessels, the needle cavity of the hollow puncture needle 6 is already filled with the injection, completely eliminating the possibility of air entering the visible or potential tissue gaps, cavities, and blood vessels.

[0133] In another embodiment, when the medical puncture device is in a diversion state, that is, when the length of the hollow puncture needle 6 extending from the front closed end of the syringe is within the diversion length range (or when the front end of the hollow puncture needle 6 penetrates into the visible or potential tissue gap, cavity system, or blood vessel), the peripheral wall needle hole 6b is completely located in the injection holding area 7, so that the flow rate of the peripheral wall needle hole 6b is maximized, thereby improving the injection speed.

[0134] The above three embodiments can be implemented individually or in combination.

[0135] An embodiment that can prevent the fluid from flowing back and overflowing from the pinhole 6b in the peripheral wall is described below.

[0136] When the front needle hole 6a is connected to the injection containing area 7 and the peripheral wall needle hole 6b is still located behind the movable sealing part 3, or when the front needle hole 6a is located in the apparent or potential tissue gap, cavity system, or blood vessel and the peripheral wall needle hole 6b is still located behind the movable sealing part 3, there is a risk of injection backflow and reverse overflow from the peripheral wall needle hole 6b. For this reason, an elastic sheath 4 can be provided in the elastic push assembly to cover the hollow puncture needle 6. When the peripheral wall needle hole 6b is located behind the movable sealing part 3 (i.e., the peripheral wall needle hole 6b is not connected to the injection containing area 7), the elastic sheath 4 can keep the peripheral wall needle hole 6b blocked, thereby effectively avoiding injection backflow and overflow, preventing contamination of the rear area of ​​the movable sealing part 3, reducing fluid loss, and improving product reliability.

[0137] In fact, even if the elastic sheath 4 is not used to block the pinhole 6b in the peripheral wall, it can also be used only as an elastic connection component between the movable sealing part 3 and the pressing part 2. Specifically, by pressing the pressing part 2 forward, the elastic sheath 4 between the movable sealing part 3 and the pressing part 2 can be squeezed, so that a rebound force is formed between the movable sealing part 3 and the pressing part 2, driving the movable sealing part 3 to move forward. In addition, the elastic connection component between the movable sealing part 3 and the pressing part 2 can also be a spring 5 whose axial ends respectively connect the movable sealing part 3 and the pressing part 2. The spring 5 and the elastic sheath 4 can be provided separately or used in combination.

[0138] The elastic connection between the movable sealing part 3 and the pressing part 2 can also be achieved by other means other than providing an elastic connection component. For example, the movable sealing part 3 and the pressing part 2 can be provided as an integrally formed elastic component.

[0139] The following describes various different embodiments of implanting medical devices into visible or potential tissue gaps, cavities, and blood vessels through a medical puncture device. For ease of understanding, the implanted medical device takes a filamentary or tubular implant 11 as an example. Of course, the implant 11 can also be a needle-shaped implant, an electrode, a sensor, etc.

[0140] Specifically, the medical puncture device is provided with an implant guide structure for guiding the implant 11 into the needle cavity of the hollow puncture needle 6 .

[0141] In one embodiment, referring to Figures 17 to 19 The implant guide structure includes an inclined guide groove 3a formed on the movable sealing part 3 and extending obliquely toward the hollow puncture needle 6. When the injection containing area 7, the peripheral wall needle hole 6b and the front end needle hole 6a are connected, the injection is first allowed to expand the visible or potential tissue gap, cavity system, and blood vessel, and then the implant 11 is implanted into the expanded visible or potential tissue gap, cavity system, and blood vessel through the inclined guide groove 3a, the peripheral wall needle hole 6b, the needle cavity of the hollow puncture needle 6 and the front end needle hole 6a.

[0142] It should be noted that the inclined guide groove 3 a may be a through groove penetrating in the front-rear direction, or may be a non-through groove formed on the upper surface of the movable sealing portion 3 .

[0143] When the inclined guide groove 3a is a through groove, the implant guide structure may also include a one-way flap assembly 9 embedded in the inclined guide groove 3a and capable of opening and closing. The one-way flap assembly 9 is in a normally closed state when not subjected to external force, so as to prevent the injection in the injection containing area 7 from leaking therefrom. However, when subjected to an opening force, the multiple flaps thereof may be stretched open, so that the implant 11 may pass through the stretching opening to the peripheral wall needle hole 6b. Alternatively, the implant guide structure may also include a guide groove seal inserted into the inclined guide groove 3a. When the implant 11 needs to be implanted, the guide groove seal may be pulled out first.

[0144] When the inclined guide groove 3a is a non-through groove, it can be directly punctured by the implant 11, or after being punctured by other puncturing members, the implant 11 is passed through the puncture port to penetrate into the peripheral wall needle hole 6b.

[0145] In this embodiment, in order to match the guidance of the inclined guide groove 3a, the peripheral wall pinhole 6b can be set as an inclined hole opening toward the oblique rear, so that the peripheral wall pinhole 6b can be aligned with the inclined guide groove 3a to accurately introduce the implant 11.

[0146] In another embodiment, referring to Fig. 20 and Fig.21 The implant guide structure includes an inclined guide needle hole 6c formed on the peripheral wall of the hollow puncture needle 6 and opening obliquely toward the rear. In the diversion state of the medical puncture device, the inclined guide needle hole 6c is always maintained behind the movable sealing part 3. The implant 11 can penetrate into the needle cavity of the hollow puncture needle 6 through the inclined guide needle hole 6c, and be implanted into the expanded visible or potential tissue gap, cavity system, and blood vessel through the front end needle hole 6a.

[0147] Similar to the previous embodiment, the implant guide structure may also include a one-way valve assembly 9 embedded in the inclined guide pinhole 6c and openable and closable, or a pinhole seal 10 inserted into the inclined guide pinhole 6c. The implant 11 can be implanted by first opening the one-way valve assembly 9 or pulling out the pinhole seal 10.

[0148] In another embodiment, referring to Fig. 22 The implant guide structure includes a puncturable middle guide groove 2c formed in the middle of the rear end surface of the pressing part 2, and the hollow puncture needle 6 is formed with a rear end needle hole, and the rear end needle hole is axially aligned with the middle guide groove 2c. When the implant 11 needs to be implanted, the middle guide groove 2c can be punctured first, and then the implant 11 can be inserted into the needle cavity of the hollow puncture needle 6 through the puncture hole of the middle guide groove 2c and the rear end needle hole of the hollow puncture needle 6, and then it can be further implanted into the expanded visible or potential tissue gap, cavity system, and blood vessel through the front end needle hole 6a.

[0149] Several embodiments of medical puncture devices formed into assembled structures are described below.

[0150] In one embodiment, the medical puncture device includes a puncture control module and a fluid storage module that are independently processed and formed. Among them, the puncture control module includes a first syringe unit and an elastic push assembly and a hollow puncture needle 6 arranged in the barrel cavity of the first syringe unit. In combination with the above-mentioned different embodiments, it can be seen that the puncture control module may also include elastic sheath 4, spring 5 and other components. The fluid storage module includes a second syringe unit, an injection accommodating area 7 formed in the barrel cavity of the second syringe unit, and a module package that is 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 the first syringe unit and the second syringe unit are spliced ​​together to form a syringe 1. In combination with the above-mentioned different embodiments, it can be seen that the fluid storage module may also include front end seals 8 and other components.

[0151] It can be seen that the puncture control module and the fluid storage module can be separately manufactured and then assembled into a medical puncture device. The module packaging is used to seal the rear end of the injection containing area 7. When the puncture control module and the fluid storage module are assembled, the module packaging can be disassembled.

[0152] In another embodiment, the medical puncture device includes a puncture control module and a fluid storage module that are independently processed and formed. Among them, the puncture control module includes a first syringe unit and a pressing part 2 and a hollow puncture needle 6 arranged in the barrel cavity of the first syringe unit. In combination with the above-mentioned different embodiments, it can be seen that the puncture control module may also include elastic sheath 4, spring 5 and other components. The fluid storage module includes a second syringe unit, an injection accommodating area 7 formed in the barrel cavity of the second syringe unit, and a movable sealing part 3 encapsulated at the rear end of the second syringe unit. At this time, the movable sealing part 3 is used to seal the rear end of the injection accommodating 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, they form a syringe 1, and the movable sealing part 3 and the pressing part 2 form a front-to-back elastic connection. In combination with the above-mentioned different embodiments, it can be seen that the fluid storage module may also include components such as a front end seal 8.

[0153] 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. Among them, the puncture control module includes a first syringe unit and a pressing part 2 and a hollow puncture needle 6 arranged in the barrel cavity of the first syringe unit. In combination with the above-mentioned different embodiments, it can be seen that the puncture control module may also include elastic sheaths 4, springs 5 ​​and other components. The transition connection module includes a second syringe unit and a movable sealing part 3 arranged in the barrel cavity of the second syringe unit. The fluid storage module includes a third syringe unit, an injection accommodating area 7 formed in the barrel cavity of the third syringe unit, and a module package that is 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 a syringe 1, and the movable sealing part 3 and the pressing part 2 are elastically connected in front and back. In combination with the above-mentioned different embodiments, it can be seen that the fluid storage module may also include front end seals 8 and other components.

[0154] A second exemplary embodiment of the present invention provides a medical device assembly, referring to Fig.18 and Fig. 22 , which includes an implant 11 and the above-mentioned medical puncture device with an implant guide structure, so that the implant 11 can be implanted into the animal's visible or potential tissue gap, cavity system, blood vessel (including but not limited to the suprachoroidal space, epidural space, pleural cavity, peritoneal cavity, joint cavity, artery, vein) through the medical puncture device. In addition, the medical device assembly in this exemplary embodiment obviously has all the technical effects brought by the above-mentioned medical puncture device, so it will not be repeated here.

[0155] In one embodiment, the medical device assembly also includes a hollow auxiliary guide needle 12 that matches the implant guide structure, and the diameter of the needle cavity of the auxiliary guide needle 12 is sufficient for the implant 11 to penetrate. When performing the implant 11 implantation operation, the auxiliary guide needle 12 is first connected to the implant guide structure, and the implant 11 can be sequentially passed through the needle cavity of the auxiliary guide needle 12 and the implant guide structure to be introduced into the needle cavity of the hollow puncture needle 6, and then implanted into the visible or potential tissue gap, cavity system, and blood vessel through the front needle hole 6a.

[0156] For example, refer to Fig.18The implant guide structure includes a through inclined guide groove 3a and a one-way flap assembly 9 embedded in the inclined guide groove 3a and openable and closable, and the peripheral wall needle hole 6b is set as an inclined hole opening obliquely toward the rear. When implanting the implant 11, the one-way flap assembly 9 is first opened by the auxiliary guide needle 12 to penetrate the inclined guide groove 3a, and the front end of the auxiliary guide needle 12 penetrates the peripheral wall needle hole 6b, and then the implant 11 is implanted into the visible or potential tissue gap, cavity system, and blood vessel through the needle cavity of the auxiliary guide needle 12, the needle cavity of the hollow puncture needle 6, and the front end needle hole 6a in sequence.

[0157] In another embodiment, the implant guide structure includes an inclined guide groove 3a arranged through the front-to-back direction and a guide groove seal inserted in the inclined guide groove 3a. The auxiliary guide needle 12 can pierce the guide groove seal forward and the front end penetrates the needle hole 6b of the surrounding wall, thereby connecting the needle cavity of the hollow puncture needle 6.

[0158] In another embodiment, the inclined guide groove 3a is formed on the upper surface of the movable sealing part 3 and is a non-through groove. The auxiliary guide needle 12 can pierce the inclined guide groove 3a forward and the front end penetrates the needle hole 6b of the peripheral wall, thereby connecting the needle cavity of the hollow puncture needle 6.

[0159] The peripheral wall needle hole 6b in the above embodiment can be formed as an inclined hole opening obliquely toward the rear, so that when the auxiliary guide needle 12 passes through the inclined guide groove 3a, the front end of the auxiliary guide needle 12 can be aligned with the inclined hole.

[0160] In another embodiment, the implant guide structure includes an inclined guide needle hole 6c formed on the peripheral wall of the hollow puncture needle 6 and opening obliquely toward the rear. In the diversion state of the medical puncture device, the inclined guide needle hole 6c is located behind the movable sealing part 3, and the auxiliary guide needle 12 can extend into the inner cavity of the syringe from the rear opening end of the syringe and penetrate into the inclined guide needle hole 6c, thereby connecting with the needle cavity of the hollow puncture needle 6.

[0161] Furthermore, the implant guide structure may also include a one-way valve assembly 9 embedded in the inclined guide needle hole 6c and openable and closable, or a needle hole seal 10 inserted in the inclined guide needle hole 6c, so that the auxiliary guide needle 12 can push the one-way valve assembly 9 forward or pierce the needle hole seal 10 forward, thereby connecting the needle cavity of the hollow puncture needle 6.

[0162] Or, refer to Fig. 22The implant guide structure includes a middle guide groove 2c, and the hollow puncture needle 6 is formed with a rear end needle hole, which is axially aligned with the middle guide groove 2c. When implanting the implant 11, the middle guide groove 2c is first punctured by the auxiliary guide needle 12, so that the auxiliary guide needle 12 is axially aligned with the rear end needle hole of the hollow puncture needle 6, and then the implant 11 is sequentially passed through the needle cavity of the auxiliary guide needle 12 and the rear end needle hole of the hollow puncture needle 6 into the needle cavity of the hollow puncture needle 6, and then further implanted into the visible or potential tissue gap, cavity system, and blood vessel through the front end needle hole 6a.

[0163] The medical puncture device and medical device assembly of the present invention can be used for the exploration, expansion, injection of the cavities such as the suprachoroidal cavity of the eye, as well as the implantation of drugs, catheters or other medical devices. Currently, the most commonly used intraocular injection method is intravitreal injection, but the efficiency of some drugs or gene therapy vectors penetrating the posterior limiting membrane of the vitreous and the inner layer of the retina 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 easy to flow out of the eyeball with the circulation of aqueous humor, affecting the local concentration and pharmacokinetics of the drugs, and may also cause side effects, such as increased intraocular pressure and cataracts. In some cases, in order to enable the drug or gene therapy vector to reach an effective concentration in the outer layer of the retina, the retinal pigment epithelium and / or the choroid, the hollow puncture needle can be penetrated from the retina to the subretina or penetrated from the retina and the retinal pigment epithelium to the subretinal pigment epithelium space on one side of the vitreous cavity, and then the drug or gene therapy vector is injected, which is difficult to inject and prone to injection failure.

[0164] Suprachoroidal injection is a route of administration that achieves higher drug concentrations in the choroid, retinal pigment epithelium, and / or outer retina, with lower vitreous drug concentrations.

[0165] In some cases, such as choroidal melanoma, precise targeted injection of therapeutic agents into the suprachoroidal space may improve efficacy and reduce side effects. However, for the eye, its structure is small, and it is quite difficult to use existing devices or methods to explore, open, inject or insert medical devices such as catheters into the suprachoroidal space, especially to insert medical devices such as catheters into specific locations in the suprachoroidal space.

[0166] Some methods of puncturing the suprachoroidal space are to make the length of the exposed puncture needle equal to the thickness of the sclera, and after the puncture needle is completely inserted into the sclera, the fluid is pushed to achieve suprachoroidal space injection. The technical defect of this puncture method is that the exposed length of the reserved puncture needle and the thickness of the sclera may not be completely consistent. In practical applications, the difference in scleral thickness between different people, between eyes, and between different parts of the same eye will further amplify the above technical defects. A needle that is too short may not be able to penetrate the sclera, and a needle that is too long may cross 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.

[0167] Due to the sensitivity of intraocular injection (e.g., tissue sensitivity, potential impact 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 (e.g., by pushing a plunger with their thumb or finger) to expel fluid (e.g., medication) into the eye. Due to the small size of the needle and / or the characteristics of the injected medication, such devices and methods do not allow the operator to operate and apply force more comfortably, and in some cases, the operator may not even be able to properly use the known devices and methods to deliver the medication.

[0168] In addition, injection into different target layers of the eye can cause the size of the force required for the insertion of the needle and / or the injection of the drug to change. Different layers of the eye may have different densities. For example, the density of the sclera is usually higher than that of the conjunctiva and the suprachoroidal space. The density difference of the target area or target layer may produce different external pressures at the needle port. Therefore, compared with injecting the drug into the suprachoroidal space, injecting into relatively dense eye tissues such as the sclera requires more power to discharge the drug from the needle port. In addition, the injection force required to discharge the drug also depends on the density and viscosity of the drug and the length and diameter of the needle. When injecting certain drugs into the eye through a needle (e.g., a 27G, 30G or even smaller needle), it may be necessary to apply some forces that are difficult to estimate and / or difficult to control, in order to achieve correct injection without damaging the eye tissue.

[0169] Likewise, placement of devices into intraocular regions (eg, minimally invasive placement of a catheter or wire into a desired area) is challenging given the relatively small size of the ocular structures.

[0170] According to the above, by adopting the medical puncture device and medical instrument assembly of the present invention, it is obviously possible to easily perform injection, probing, expansion or instrument implantation operations on the suprachoroidal space and other intraocular areas, and in particular, it is possible to achieve precise control of the puncture depth, stable injection and quantitative injection.

[0171] In order to easily puncture with minimal secondary damage, such as penetrating the sclera to reach the suprachoroidal space, a hollow puncture needle 6 with a beveled front end surface can be used for puncture. The hollow puncture needle 6 can also be provided with a narrow needle cavity (for example, a specification size 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 channel formed by the needle insertion. In addition, the aspect ratio of the needle cavity and the front end bevel of the hollow puncture needle 6 is the same as or different from the standard 27G and 30G needles commonly used for intraocular injection.

[0172] In some embodiments, a therapeutic agent (e.g., a drug) may be added to the injection in the injection receiving area 7. Non-limiting examples of specific drugs and drug classes include beta-adrenergic receptor antagonists (e.g., carteolol, citamol, betaxolol, levobunolol, naprolol, timolol), mimetics (e.g., pilocarpine, carbachol, physostigmine), sympathomimetics (e.g., epinephrine, infiltrates), carbonic anhydrase inhibitors (e.g., acetazolamide, dorzolamide), topoisomerase inhibitors (e.g., topotecan, irinotecan, camptothecin, lamellarin), and styrax. D, etoposide, teniposide, doxorubicin, mitoxantrone, ammonia acne), prostaglandins, antimicrobial compounds, antifungals (e.g. chloramphenicol, chlortetracycline, ciprofloxacin, aspergillus, fusidic acid, gentamicin, neomycin, norfloxacin, ofloxacin, polymyxin, tetracycline, tobramycin, quinoline), antiviral compounds (e.g. acyclovir, ciprovir), aldose reductase inhibitors, anti-inflammatory and / or antiallergic compounds (e.g. steroidal compounds, such as betamethasone, clobetasone, dexamethasone, lometolone, hydrochloride cortisone, prednisolone and nonsteroidal compounds (e.g., anzoline, bromfenac, diclofenac, indomethacin, lodoxamide, saprofen, sodium cromoglycate), artificial tears / dry eye treatments, local anesthetics (e.g., methoxycaine, lidocaine, oxybuprocaine, ciprofloxacin), diclofenac, uracilone and growth factors (e.g., epidermal growth factor, mydriatic and cycloplegic drugs, mitomycin C and collagenase inhibitors), and treatments for age-related macular degeneration (e.g., pegaptanib sodium, ranibizumab, aflibercept, bevacizumab).

[0173] In some embodiments, the therapeutic agent can 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 molecule (PCAM), vascular cell adhesion molecule (VCAM), a cytokine or growth factor antagonist that induces leukocyte adhesion (e.g., tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), monocyte chemoattractant protein-1 (MCP-1), vascular endothelial growth factor (VEGF)).

[0174] In some embodiments, two drugs can be delivered by the aforementioned method. The two drugs can be administered in the form of a combined formulation or in the form of two separate formulations in sequence. For example, a VEGF inhibitor and VEGF are provided. The VEGF inhibitor can be an antibody, such as a humanized monoclonal antibody, bevacizumab, ranibizumab, etc., or it can be aflibercept or pegaptanib.

[0175] 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 antibodies, ENMD2076, Sutent (sunitinib malate), INDUS815C, R84 antibody, KD019, NM3, allogeneic mesenchymal precursor cells and anti-VEGF agents or antibodies, MGCD265, MG516, VEGF-receptor kinase inhibitors, MP0260, NT503, anti-DLL4 / VEGF bispecific antibodies, PAN90806, Palomod 529, BD0801 antibody, XV615, ruxitinib (AL3810, E3810), AMG706 (moxanib diphosphate), AAV2-sFLT01, soluble Flt1 receptor, cediranib (Recentin), AV-951 (tivozanib, KRN-951), stevastatin (regorafenib), vorasertinib (BI6727), CEP11981, KH903, Lenva tinib (E7080), terameprocol (EM1421), ranibizumab (Lucentis), Votrient (pazopanib hydrochloride), PF00337210, PRS050, SP01 (curcumin), carboxamidotriazole orotate, hydroxychloroquine, linifaranib (ABT869, RG3635), ilutur (fluocinolone), ALG1001, AGN150998, DARPin MP0112, AVAAP (101), AMGAP (101), AVAAP (351)), BMS690514, KH902, gorvatinib (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 / r84 antibody, troponin (BLS0597), EG3306, vatalanib (PTK787), Bmab100, GSK2 136773, anti-VEGFR replacement enzyme, Avila, CEP7055, CLT009, ESBA903, HuMax-VEGF antibody, GW654652, HMPL010, GEM220, HYB676, JNJ17029259, TAK593, XtendVEGF antibody, Nova21012, Nova21013, CP564959, smart anti-VEGF antibody, AG028262, AG13958, CVX241, SU14813, PRS055, PG501, PG545, PT1101, TG100948, I CS283, XL647, enzastatin hydrochloride (LY317615), BC194, quinoline, COT601M06.1, COT604M06.2, MabionVEGF, SIR-Spheres conjugated to anti-VEGF or VEGF-R antibodies, apatinib (YN968D1), and AL3818.

[0176] Additionally, VEGF inhibitors or VEGF antagonists may be combined with one or more of the agents listed herein or with other agents known in the art.

[0177] The medical puncture device and the medical instrument assembly of the present invention can also be used for the treatment of glaucoma.

[0178] Glaucoma is an eye disease that affects millions of people and is associated with increased intraocular pressure, which is caused by the inability of the eye's drainage system to adequately drain aqueous humor from the anterior chamber or by excessive production of aqueous humor by the ciliary body. The accumulation of aqueous humor and the resulting increase in intraocular pressure can lead to irreversible damage to the optic nerve and retina, and in severe cases, blindness.

[0179] Specifically, there are two main types of glaucoma: open-angle and closed-angle. Open-angle glaucoma refers to a type of glaucoma in which the intraocular pressure is elevated but the anterior chamber angle (drainage angle) remains open, and the common cause is trabecular meshwork obstruction. Whereas closed-angle glaucoma refers to a type of glaucoma in which the intraocular pressure is elevated due to partial or complete closure of the anterior chamber angle. In this type of glaucoma, swelling, adhesions, or forward movement of the iris closes the anterior chamber angle and prevents fluid from entering the trabecular meshwork, thereby hindering the outflow of aqueous humor from the eye.

[0180] Currently, glaucoma can be treated surgically, which involves placing drainage devices in the eye to form a path for aqueous humor drainage (such as subconjunctival drainage, Schlemm's canal drainage, and suprachoroidal drainage) between the anterior chamber and various structures of the eye. The surgical procedure for implanting the drainage device can be to first insert a delivery device for placing the drainage device into a specific part of the eye, and then implant the drainage device.

[0181] In some existing treatment methods, a delivery device for placing a drainage device can enter the eye through the cornea (internal puncture), pass through the anterior chamber and extend into the contralateral chamber angle until the front end of the delivery device approaches the outflow site of the aqueous humor, and then the drainage device is placed, thereby forming an aqueous humor drainage channel between the anterior chamber and the outflow site of the aqueous humor. In other existing treatment methods, a delivery device for maintaining the drainage device enters the eye using an external puncture method, which involves a step of inserting through the sclera.

[0182] However, the current surgical method for implanting the suprachoroidal aqueous humor drainage device from the external route requires a full-thickness scleral incision, which is relatively traumatic and takes a long time to operate. The surgical method for implanting the suprachoroidal aqueous humor drainage device from the internal route cannot accurately control the puncture depth, and is prone to excessive puncture and damage to other eye tissues, or cannot be implanted normally due to insufficient puncture depth. In addition, the external and internal implantation surgical methods for the subconjunctival space also have the problem of being unable to accurately control the puncture depth. It can be seen that the current surgical methods for the choroidal and subconjunctival aqueous humor drainage devices for the treatment of glaucoma still have a lot of room for improvement.

[0183] 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 device assembly to treat glaucoma. Specifically, by using the suprachoroidal space and / or the subconjunctival space as the target aqueous humor outflow area, or by probing, dilating or implanting an instrument (such as implanting a drainage device) between the target outflow area and the inflow area (such as the anterior chamber), it is helpful to drain the aqueous humor from the anterior chamber.

[0184] First, a method for implanting a drainage device into 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 at a target aqueous humor outflow area in the eye; (b) delivering fluid through the needle to form an enlarged space in the target 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 is releasably connected to the needle; and (d) releasing the needle from the drainage device, thereby implanting the drainage device into the eye to form fluid communication between the anterior chamber and the target outflow area.

[0185] In some embodiments, the needle is caused to penetrate the sclera. Optionally, the method includes performing a conjunctival incision before the needle penetrates the sclera. Optionally, the needle is caused to penetrate the conjunctiva and the sclera, and the method does not include a conjunctival incision. Optionally, the target outflow area is between the sclera and the choroid, and the enlarged space is the suprachoroidal space. Optionally, the positioning step includes positioning the front end of the needle in the suprachoroidal space and toward the anterior chamber angle.

[0186] In some embodiments, the drainage device is disposed in the needle. Optionally, the drainage device is disposed in the needle cavity of the needle, or the drainage device is formed as a sleeve disposed outside the needle.

[0187] In some embodiments, the positioning step includes advancing the drainage device from the needle cavity to the front end of the needle or advancing the drainage device sleeved 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 cavity or sleeve it outside the needle. Optionally, the positioning step includes piercing the anterior chamber angle with the front end of the needle and / or the drainage device. Optionally, the releasing step includes removing the needle and / or the 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.

[0188] In some embodiments, the drainage device is connected to the needle before or after the inserting step. Optionally, the drainage device is connected to the needle before or after the fluid is delivered. Optionally, the drainage device is releasably connected to the front end of the needle.

[0189] 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 pierce 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 the outflow end of the drainage device in the suprachoroidal space.

[0190] In some embodiments, the positioning step includes positioning the front end of the needle in the suprachoroidal space and away from the anterior chamber angle. Optionally, the drainage device is disposed in the needle, wherein the drainage device is disposed in the needle cavity 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 sleeved 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 cavity or sleeve it outside 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.

[0191] In certain embodiments, the above method further comprises piercing the anterior chamber angle to form an implant passage. Optionally, the inflow end of the drainage device is positioned by the implant passage in the anterior chamber. Optionally, the implant passage can be formed by the same needle or different puncture elements. Optionally, the same needle or different puncture elements can be used to pierce the conjunctiva, sclera, suprachoroidal space and the anterior chamber angle. Optionally, the needle can be inserted into the eye at the first entry point, and the same needle or different puncture elements can be inserted into the eye at the second entry point different from the first entry point to form an implant passage.

[0192] In some embodiments, the outflow end of the drainage device includes a portion between the first and second entry points outside the sclera. 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 under the conjunctiva. Optionally, the above method includes cutting the conjunctiva to expose the sclera, and after positioning the inflow end of the drainage device through the implant channel in the anterior chamber, suturing the conjunctiva to cover the portion of the drainage device outside the sclera. Optionally, the portion of the drainage device outside the sclera includes a drainage device shunt port, wherein the drainage device shunt port can be located under the conjunctiva.

[0193] In some embodiments, the above methods comprise placing an antimetabolite beneath the opened conjunctiva.

[0194] In some embodiments, the needle is inserted into the eye from an external or internal approach.

[0195] In some embodiments, the target outflow area is between the conjunctiva and the sclera, and the enlarged space is the subconjunctival space. Optionally, the drainage device is disposed in the needle cavity. Optionally, the drainage device is formed as a sleeve disposed outside the needle, or the drainage device is releasably connected to the front end of the needle.

[0196] In some embodiments, another method for implanting a drainage device into 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 between the sclera and the choroid; (b) delivering fluid through the needle to form a suprachoroidal space; (c) piercing the anterior chamber angle with the front end of the needle and / or a drainage device releasably connected to the needle; (d) placing the drainage device through the anterior chamber angle so that the inflow end of the drainage device is located in the anterior chamber and the outflow end of the drainage device is located in the suprachoroidal space; and (e) removing the needle from the eye, thereby implanting the drainage device into the eye so that the anterior chamber and the suprachoroidal space are connected.

[0197] 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 between the sclera and the choroid; (b) delivering fluid through the needle to form a suprachoroidal space; (c) placing the outflow end of the drainage device in the suprachoroidal space and away from the anterior chamber angle with the needle; (d) piercing the anterior chamber angle to form an implant channel; (e) positioning the inflow end of the drainage device in the anterior chamber through the implant channel, thereby placing the drainage device in the eye so that the anterior chamber and the suprachoroidal space are connected.

[0198] In some embodiments, a portion of the drainage device is located outside the sclera. Optionally, a portion of the extra-scleral drainage is located below the conjunctiva. Optionally, a portion of the drainage device may be located outside the sclera and conjunctiva. Optionally, the drainage device includes a drainage device shunt located outside the sclera and conjunctiva and / or a drainage device shunt located outside the conjunctiva. Optionally, the drainage device provides fluid communication between the anterior chamber and the suprachoroidal space and between the anterior chamber and the subconjunctival space. Optionally, the drainage device provides fluid communication between the anterior chamber and the suprachoroidal space and between the anterior chamber and the extraconjunctival space.

[0199] In some embodiments, a method for implanting a drainage device into the eye from an internal route is provided, the method comprising: (a) passing a needle and / or a drainage device releasably connected to the needle through the cornea and the anterior chamber in sequence to penetrate into the suprachoroidal space or the subconjunctival space; (b) delivering fluid to the suprachoroidal space or the subconjunctival space through the needle and / or the drainage device; (c) placing the inflow end of the drainage device into the anterior chamber and the outflow end of the drainage device into the suprachoroidal space or the subconjunctival space; and (d) removing the needle from the eye, thereby implanting the drainage device into the eye to provide fluid communication between the anterior chamber and the suprachoroidal space or the subconjunctival space.

[0200] In some embodiments, the drainage device contains a drug or biologic.

[0201] In some embodiments, the drainage device is configured to be threaded forward or advanced along the needle and exposed at the leading end of the needle when the needle reaches the target outflow area.

[0202] In some embodiments, the drainage device is an intraocular drainage device disposed within a needle.

[0203] Reference Figure 23 to Figure 29 A method for implanting a drainage device into the eye is now specifically described. First, a needle is inserted into the eye through the conjunctiva and the sclera to form a delivery channel in the eye, wherein the delivery channel ends between the sclera and the choroid. A fluid such as a viscoelastic fluid is delivered through the needle to form a suprachoroidal space between the sclera and the choroid. The needle is then rotated so that the front end of the needle is positioned toward the anterior chamber angle. Since the suprachoroidal space has been expanded by the viscoelastic fluid, there is more space to adjust the direction of the front end of the needle without causing damage to the choroid or other surrounding eye tissues. Next, the needle is moved so that the front end of the needle pierces the anterior chamber angle, so that the front end opening of the needle is exposed in the anterior chamber. Then, the drainage device can be inserted into the needle (or the drainage device can be pre-inserted into the needle before inserting the needle and injecting the fluid) and moved to extend from the front end opening of the needle. In this way, the drainage device can be positioned to pass through the anterior chamber angle so that the inflow end of the drainage device is placed in the anterior chamber and the outflow end of the drainage device is placed in the suprachoroidal space. After the drainage device is placed, the needle is removed from the eye, leaving the drainage device in place to provide fluid communication between the anterior chamber and the suprachoroidal space.

[0204] It can be seen that the method of the above illustrated embodiment is a minimally invasive method, which does not require cutting the sclera in its entirety through surgery, or separating the sclera and choroid through surgery, or suturing the cut sclera or conjunctiva after surgery. Therefore, the minimally invasive method can reduce eye tissue damage, reduce the requirements for surgical techniques, and save surgical time.

[0205] Reference Figure 30 to Figure 36 ,or Figures 37 to 42, another method for implanting a drainage device into the eye is now described in detail. First, a needle is inserted into the eye through the conjunctiva and sclera to form a delivery channel in the eye, wherein the delivery channel terminates between the sclera and the choroid. A fluid such as a viscoelastic fluid is delivered through the needle to form a suprachoroidal space between the sclera and the choroid. The needle is then rotated to position the front end of the needle away from the anterior chamber angle. Since the suprachoroidal space has been expanded by the fluid, there is more space to facilitate adjusting the direction of the front end of the needle without causing damage to the choroid or other surrounding eye tissues. Next, the drainage device is inserted into the needle (or the drainage device can be pre-inserted into the needle before the needle is inserted and the fluid is injected), and the drainage device is placed at the front end of the needle, and then the needle is removed so that the outflow end of the drainage device is located away from the anterior chamber angle, and the other end is located outside the sclera. Further, the same or different needles (not necessarily hollow) are used to pierce the sclera and pass through the suprachoroidal space and the anterior chamber angle to form an implant channel. The other end of the drainage device is then inserted into the implant channel to position 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.

[0206] In the method of the above-mentioned illustrated embodiment, a portion of the drainage device is placed outside the sclera, for example, under the conjunctiva or outside the conjunctiva. Moreover, the portion of the drainage device placed outside the sclera may be formed with a drainage device shunt port, so that the drainage device can simultaneously provide fluid communication between the anterior chamber and the suprachoroidal space and between the anterior chamber and the subconjunctival space, or can simultaneously provide fluid communication between the anterior chamber and the suprachoroidal space and between the anterior chamber and the space outside the conjunctiva, thereby achieving a double drainage effect.

[0207] It should be noted that the inflow end, outflow end and / or shunt port of the drainage device may include one or more valves, such as a one-way valve, to control the fluid to flow out of the anterior chamber in one direction. For example, the flow of the fluid can be controlled so that the fluid can only flow from the anterior chamber to the outflow end of the drainage device (i.e., to the suprachoroidal space or the subconjunctival space) and / or the shunt port of the drainage device (i.e., to the subconjunctival space or outside the conjunctiva), and will not flow back from the outflow end of the drainage device or the shunt port of the drainage device into the anterior chamber, thereby ensuring that the drainage device can achieve the effect of reducing intraocular pressure.

[0208] Reference Figure 43 to Figure 45A method of implanting a drainage device into the eye from the internal route using the medical puncture device (or medical device assembly) of the present invention is now specifically described. First, the hollow puncture needle of the medical puncture device is passed through the cornea and the anterior chamber to be inserted into the subconjunctival space (or suprachoroidal space). A fluid such as a viscoelastic fluid enters the subconjunctival space through the hollow puncture needle, 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 fluid communication between the anterior chamber and the subconjunctival space.

[0209] Compared with the existing internal implant surgery method, the method of the above-mentioned illustrated embodiment can accurately control the injection and expansion of the subconjunctival cavity, thereby effectively reducing or avoiding the risk of the hollow puncture needle piercing the conjunctiva.

[0210] In order to make the medical puncture device and medical instrument assembly of the present invention suitable for injection, probing, dilation or instrument implantation in the visible or potential tissue spaces, cavities, and blood vessels of the eye, and in particular suitable for the treatment of the suprachoroidal space and glaucoma, in combination with the aforementioned embodiments, the medical puncture device can be further formed into an eye puncture device, and the medical instrument assembly can be further formed into an eye implantation instrument assembly.

[0211] The following will supplement the description of some features of the ocular puncture device that are different from the universal medical puncture device of the present invention, and supplement the description of some features of the ocular implantation device assembly that are different from the universal medical device assembly of the present invention. In addition, in the present invention, all the aforementioned embodiments of the universal medical puncture device and medical device assembly can be applied to the ocular puncture device and the ocular implantation device assembly.

[0212] For the eye puncture device, the injection containing area 7 thereof is pre-stored with an ocular injection suitable for ocular injection, which may refer to the types of injections listed above, including ocular therapeutic agents for treating ocular diseases (such as glaucoma, suprachoroidal space or subconjunctival space diseases), or a shapeable ocular injection that can be shaped after being injected into and expanding the visible or potential tissue spaces, cavities, and blood vessels (such as the suprachoroidal space and subconjunctival space) of the eye.

[0213] For eye puncture, the hollow puncture needle 6 can be 30G to 23G.

[0214] The implant 11 suitable for eye implantation is an eye implant. It can be seen from the aforementioned eye surgery method that the eye implants can be roughly divided into three types according to the differences in the installation and implantation methods of the eye implants. Among them, the first type of eye implant is pre-installed in the needle cavity of the hollow puncture needle 6 and can be advanced to be released from the front needle hole 6a. The second type of eye implant is sleeved outside the hollow puncture needle 6 and can be advanced to be released from the front end of the hollow puncture needle 6. The third type of eye implant is releasably connected to the front end of the hollow puncture needle 6.

[0215] 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 glaucoma drainage treatment.

[0216] When used for suprachoroidal space puncture, the ocular puncture device includes a scleral puncture state after the hollow puncture needle 6 punctures the front closed end of the syringe. In the scleral puncture state, the length range of the hollow puncture needle 6 extending from the front closed end of the syringe is the scleral puncture length range. Within the scleral puncture length range, preferably, the peripheral wall needle hole 6b is at least partially connected to the injection agent holding area 7.

[0217] When used for suprachoroidal space puncture, the ocular puncture device also includes a suprachoroidal space diversion state after the hollow puncture needle 6 punctures the front closed end of the syringe. In the suprachoroidal space diversion state, the length range of the hollow puncture needle 6 extending from the front closed end of the syringe is the suprachoroidal space diversion length range. Within the suprachoroidal space diversion length range, preferably, the peripheral wall needle hole 6b is located in the injection holding area 7.

[0218] When used for subconjunctival space puncture, the eye puncture device includes a subconjunctival space diversion state after the hollow puncture needle 6 pierces the front closed end of the syringe. In the subconjunctival space diversion state, the length range of the hollow puncture needle 6 extending from the front closed end of the syringe is the subconjunctival space diversion length range. Within the subconjunctival space diversion length range, preferably, the peripheral wall needle hole 6b is located in the injection holding area 7.

[0219] For the ocular implantation device assembly, the ocular puncture device, the auxiliary guide needle 12 and the ocular implants included therein can be arranged to be pre-assembled or non-pre-assembled. When in use, the ocular injection is first injected into the tissue gap, cavity system and blood vessels of the eye through the ocular puncture device to expand them, and then the ocular implant is introduced into the needle cavity of the hollow puncture needle 6 through the needle cavity of the auxiliary guide needle 12 and the implant guide structure of the ocular puncture device, and finally the ocular implant extends from the front needle hole 6a to be implanted into the expanded tissue gap, cavity system and blood vessels.

[0220] Typically, the ocular implant is in the form of a thread or a tube. For example, the aforementioned drainage device suitable for glaucoma drainage treatment can be configured in the form of a tube.

[0221] As can be seen from the aforementioned glaucoma treatment methods, by using an ocular implant device 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, thereby providing fluid communication between the suprachoroidal space and the anterior chamber. Alternatively, the outflow end of the drainage device can be placed in the subconjunctival space and the inflow end of the drainage device can be placed in the anterior chamber, thereby providing fluid communication between the subconjunctival space and the anterior chamber. Alternatively, the drainage device is provided with a drainage device shunt port located between the inflow end and the outflow end of the drainage device, and by using an ocular implant device assembly, the inflow end of the drainage device can be placed in the anterior chamber, and the outflow end of the drainage device can be placed in the suprachoroidal space and the drainage device shunt port can be placed outside the sclera (e.g., the subconjunctival space or outside the conjunctiva) to achieve a double drainage effect.

[0222] In order to facilitate adjustment of 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. Combined with the above method, it can be seen that the flexible drainage catheter is particularly suitable for the double drainage treatment method.

[0223] The optional implementation modes of the embodiments of the present invention are 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 implementation modes. Within the technical concept of the embodiments of the present invention, various simple modifications can be made to the technical scheme of the embodiments of the present invention, and these simple modifications all belong to the protection scope of the embodiments of the present invention.

[0224] It should also be noted that the various specific technical features described in the above specific implementation methods can be combined in any suitable manner without contradiction. In order to avoid unnecessary repetition, the embodiments of the present invention will no longer separately describe various possible combinations.

[0225] In addition, various implementation modes of the embodiments of the present invention may be arbitrarily combined, and as long as they do not violate the concept of the embodiments of the present invention, they should also be regarded as the contents disclosed by the embodiments of the present invention.

Claims

1. An eye puncture device, characterized in that: The ocular puncture device comprises a syringe (1), an elastic push assembly, a hollow puncture needle (6), at least one injection containing area (7) and an ocular injection suitable for ocular injection. The syringe (1) comprises a syringe front closed end and a syringe rear open end. The elastic push assembly comprises a pressing portion (2) and a puncturable movable sealing portion (3) located in the inner cavity of the syringe and capable of forming a front-to-back elastic connection with the pressing portion (2). The hollow puncture needle (6) is fixedly connected to the pressing portion (2) and is formed with a front needle hole (6a) and a peripheral wall needle hole (6b). The injection containing area (7) is formed at the front closed end of the syringe and the inner cavity of the syringe. In the inner cavity area of ​​the syringe enclosed by the peripheral wall and the movable sealing portion (3), the ocular injection is pre-stored in the injection containing area (7); the ocular puncture device is configured to be able to push the hollow puncture needle (6) forward to puncture the front closed end of the syringe by pressing the pressing portion (2), so that the ocular injection can flow outward from the injection containing area (7), the peripheral wall needle hole (6b) and the front end needle hole (6a) which are connected in sequence and are in a diversion state; in the diversion state, the movable sealing portion (3) can move forward under the action of the rebound force between it and the pressing portion (2).

2. The eye puncturing device according to claim 1, characterized in that: The ocular injection comprises an ocular therapeutic agent for treating ocular diseases; and / or, the ocular injection comprises a shapeable ocular injection that can be shaped after being injected into and expanding the apparent or potential tissue space, cavity system or vessel of the eye.

3. The eye puncturing device according to claim 1, characterized in that: The specification of the hollow puncture needle (6) is 30G to 23G.

4. The eye puncturing device according to claim 1, characterized in that: The eye puncture device comprises a first type of eye implant pre-installed in the needle cavity of the hollow puncture needle (6) and capable of advancing to be released from the front needle hole (6a); And / or, the eye puncture device comprises a second type of eye implant which is sleeved outside the hollow puncture needle (6) and can move forward to be released from the front end of the hollow puncture needle (6); And / or, the eye puncture device comprises a third type of eye implant releasably connected to the front end of the hollow puncture needle (6).

5. The eye puncturing device according to claim 4, characterized in that: The first type of ocular implant, the second type of ocular implant, and the third type of ocular implant each include a drainage device suitable for glaucoma drainage treatment.

6. The eye puncturing device according to claim 1, characterized in that: The eye puncture device comprises a scleral puncture state after the hollow puncture needle (6) punctures the front closed end of the syringe. In the scleral puncture state, the length range of the hollow puncture needle (6) extending from the front closed end of the syringe is the scleral puncture length range. Within the scleral puncture length range, the peripheral wall needle hole (6b) is at least partially connected to the injection containing area (7).

7. The eye puncturing device according to claim 1, characterized in that: The eye puncture device includes a suprachoroidal space diversion state after the hollow puncture needle (6) punctures the front closed end of the syringe. In the suprachoroidal space diversion state, the length range of the hollow puncture needle (6) extending from the front closed end of the syringe is the suprachoroidal space diversion length range. In the suprachoroidal space diversion length range, the peripheral wall needle hole (6b) is located in the injection containing area (7).

8. The eye puncturing device according to claim 1, characterized in that: The eye puncture device comprises a subconjunctival cavity diversion state after the hollow puncture needle (6) punctures the front closed end of the syringe. In the subconjunctival cavity diversion state, the length range of the hollow puncture needle (6) extending from the front closed end of the syringe is the subconjunctival cavity diversion length range. Within the subconjunctival cavity diversion length range, the peripheral wall needle hole (6b) is located within the injection containing area (7).

9. The eye puncturing device according to claim 1, characterized in that: Before the hollow puncture needle (6) extends out from the front closed end of the syringe, the peripheral wall needle hole (6b) is maintained above the injection containing area (7).

10. The eye puncturing device according to claim 1, characterized in that: In the flow-guiding state, the movable sealing portion (3) can move forward to seal the peripheral wall pinhole (6b) under the action of the rebound force between the movable sealing portion (3) and the pressing portion (2).

11. The eye puncturing device according to claim 10, characterized in that: In the flow-guiding state, the movable sealing portion (3) blocks the peripheral wall needle hole (6b) when it moves forward to abut against the front closed end of the syringe.

12. The eye puncturing device according to claim 1, characterized in that: An axial limiting portion (1a) is provided in the inner cavity of the syringe and is located in front of the movable sealing portion (3) and is used to limit the forward movement of the movable sealing portion (3). The eye puncture device includes a diversion state that enables the injection containing area (7), the peripheral wall needle hole (6b) and the front end needle hole (6a) to communicate with each other. In the diversion state, the peripheral wall needle hole (6b) is located in front of the axial limiting portion (1a), and the movable sealing portion (3) can move forward under the action of the rebound force between the movable sealing portion (3) and the pressing portion (2).

13. The eye puncturing device according to claim 1, characterized in that: The eye puncture device comprises a manual control part which is connected to the movable sealing part (3) and partially extends out of the syringe.

14. The eye puncturing device according to claim 13, characterized in that: The movable sealing part (3) forms a front-to-back elastic connection with the manual control part.

15. The eye puncturing device according to claim 14, characterized in that: The syringe (1) is provided with a syringe peripheral wall groove extending in the axial direction on the peripheral wall portion located behind the movable sealing portion (3); the manual control portion comprises a pressure control slider that is slidably engaged with the syringe peripheral wall groove; the movable sealing portion (3) and the pressure control slider are elastically connected in a front-to-rear manner.

16. The eye puncturing device according to claim 1, characterized in that: The eye puncture device comprises at least one puncturable isolation seal (13) which is arranged in the inner cavity area of ​​the syringe between the movable seal (3) and the front closed end of the syringe and is capable of axial sliding. The injection containing area (7) is formed with a plurality of axially isolated injection areas by the isolation seal (13).

17. The eye puncturing device according to claim 1, characterized in that: The eye puncture device also includes an implant guide structure for guiding the eye implant into the needle cavity of the hollow puncture needle (6).

18. The eye puncturing device according to claim 17, characterized in that: The implant guide structure comprises an inclined guide groove (3a) formed on the movable sealing portion (3) and extending obliquely toward the hollow puncture needle (6).

19. The eye puncturing device according to claim 18, characterized in that: The inclined guide groove (3a) is arranged to penetrate along the front-to-back direction, and the implant guide structure further comprises a one-way flap assembly (9) embedded in the inclined guide groove (3a) and capable of opening and closing, or a guide groove seal inserted in the inclined guide groove (3a).

20. The eye puncturing device according to claim 18, characterized in that The inclined guide groove (3a) is formed on the upper surface of the movable sealing portion (3) and is a non-through groove.

21. The eye puncturing device according to claim 18, characterized in that: The peripheral wall needle hole (6b) is formed as an inclined hole opening obliquely toward the rear.

22. The eye puncturing device according to claim 17, characterized in that: The implant guide structure comprises an inclined guide needle hole (6c) formed on the peripheral wall of the hollow puncture needle (6) and opening obliquely to the rear, and the eye puncture device comprises a flow diversion state that enables the injection containing area (7), the peripheral wall needle hole (6b) and the front end needle hole (6a) to communicate with each other, and in the flow diversion state, the inclined guide needle hole (6c) is located behind the movable sealing part (3).

23. The eye puncturing device according to claim 22, characterized in that: The implant guide structure further comprises a one-way flap assembly (9) embedded in the inclined guide needle hole (6c) and capable of opening and closing, or a needle hole sealing member (10) inserted in the inclined guide needle hole (6c).

24. The eye puncturing device according to claim 17, characterized in that: The implant guide structure comprises a puncturable middle guide groove (2c) formed in the middle of the rear end surface of the pressing portion (2), and the hollow puncture needle (6) is formed with a rear end needle hole, and the rear end needle hole is axially aligned with the middle guide groove (2c).

25. An eye puncturing device according to any one of claims 1 to 24, characterized in that: The eye puncture device comprises a puncture control module and a fluid storage module which are independently processed and formed; The puncture control module comprises a first syringe unit, and the elastic push assembly and the hollow puncture needle (6) arranged in the barrel cavity of the first syringe unit; The fluid storage module comprises a second syringe unit, the injection containing area (7) formed in the barrel cavity of the second syringe unit, and a module packaging member 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.

26. An eye puncturing device according to any one of claims 1 to 24, characterized in that: The eye puncture device comprises a puncture control module and a fluid storage module which are independently processed and formed; The puncture control module comprises a first syringe unit, and the pressing portion (2) and the hollow puncture needle (6) arranged in the barrel cavity of the first syringe unit; The fluid storage module comprises a second syringe unit, the injection containing area (7) formed in the barrel cavity of the second syringe unit, and the movable sealing part (3) encapsulated 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.

27. An eye puncturing device according to any one of claims 1 to 24, characterized in that: The eye puncture device comprises a puncture control module, a transition connection module and a fluid storage module which are independently processed and formed; The puncture control module comprises a first syringe unit, and the pressing portion (2) and the hollow puncture needle (6) arranged in the barrel cavity of the first syringe unit; The transition connection module comprises a second syringe unit and the movable sealing portion (3) arranged in the barrel cavity of the second syringe unit; The fluid storage module comprises a third syringe unit, the injection containing area (7) formed in the barrel cavity of the third syringe unit, and a module packaging part 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.

28. An ocular implant device assembly, characterized in that: The ocular implant device assembly comprises an ocular implant and an ocular puncture device according to any one of claims 17 to 24.

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