Ophthalmology minimally invasive drainage apparatus with expansion and fixation functions and delivery system of ophthalmology minimally invasive drainage apparatus

Abstract

The invention provides an ophthalmology minimally invasive drainage device with an expansion fixing function and a delivery system thereof, the ophthalmology minimally invasive drainage device comprises a drainage main body with a hollow cavity and an expansion fixing device, and the drainage main body comprises a near-end part and a far-end part far away from the near-end part; the expansion fixator is in a two-dimensional plane shape or a three-dimensional shape and is provided with a first end and a second end, the first end is connected with the near end part of the drainage main body, and the second end is connected with the far end part of the drainage main body; the near end part is one end close to the suprachoroidal space and has the length of 0.2-2.5 mm, and the far end part is one end close to the anterior chamber of the eye and has the length of 0.5-3.0 mm. According to the ophthalmology department minimally invasive drainage apparatus with the expansion and fixing functions, the drainage body with the hollow cavity is adopted, and the loading and implanting requirements can be met; after being released, the dilation fixer recovers to a preset shape, so that the dilation fixer can play a role in enhancing the intraocular fixing effect while playing a drainage role, ciliary body dissociation is formed, and then the effects of promoting aqueous humor absorption and inhibiting aqueous humor secretion are achieved.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to an ophthalmic minimally invasive drainage device with expansion and fixation functions and a delivery system thereof. Background Art

[0002] MIGS (minimally invasive glaucoma surgery) is an emerging surgical procedure for the treatment of mild to moderate glaucoma. Implantation of a drain after cataract removal alone or in combination can effectively, minimally invasively, and conveniently reduce IOP (intraocular pressure). Currently, according to the different anatomical pathways of the drain to drain the aqueous humor, MIGS can be divided into three types: subconjunctival drainage, Schlemm's canal drainage, and suprachoroidal drainage. Among them, suprachoroidal drainage is an ideal approach because the suprachoroidal space is the physiological drainage pathway for the aqueous humor, has a large space, and does not form a filtration bleb during operation. At present, MIGS drains for suprachoroidal drainage can be divided into internal and external routes according to the implantation method. Representative drains for the internal route include Cypass, iStentSupra, MiniJect, etc., and representative implants for the external route include Slox Gold shunt, Aquashunt, STARflo, etc. All of the above methods can effectively reduce the IOP of glaucoma patients, but the internal approach requires cataract surgery, and there is a risk of drainage device displacement and detachment after surgery, leading to intraocular tissue damage. The external approach is highly traumatic, and severe complications such as explosive suprachoroidal hemorrhage may occur during the perioperative period, and fibrosis is obvious in the internal drainage area. The above factors limit the clinical application of suprachoroidal drainage MIGS.

[0003] Suprachoroidal space drains are mostly non-metallic pipes with an inner lumen, such as Cypass, which is made of polyimide. Due to the extrusion processing characteristics of the pipe, the pipe has fixed inner and outer diameter parameters and a fixed axial direction, which makes it easy for the pipe to slip in the suprachoroidal space after implantation, affecting the drainage effect. Therefore, in the pipe drain solution, a structure that increases the fixing effect of the pipe (such as the ring with an increased outer diameter set in Cypass) will be provided, but due to the limitation of the small overall size of the pipe (such as the outer diameter of Cypass is about 0.40mm and the inner diameter is about 0.30mm), the processing of the fixed structure is difficult. Summary of the invention

[0004] The inventors of this case have found that nickel-titanium shape memory alloy (nickel mass fraction is 54.5%-57.0%) is a shape memory alloy. Nickel-titanium shape memory alloy material has good biocompatibility and excellent shape memory properties and is currently widely used in intravascular implant devices, such as intravascular stents, filters, etc., but its application as a MIGS drain is less. Hydrus Microstent made of nickel-titanium shape memory alloy is a product of Schlemm's tube drainage method. The successful application of Hydrus Microstent shows that nickel-titanium shape memory alloy material can be successfully used in ophthalmic drains.

[0005] The present invention aims to solve at least one of the technical problems in the related art to a certain extent. To this end, the present invention provides an ophthalmic minimally invasive drainage device with an expansion and fixation function, the ophthalmic minimally invasive drainage device comprises a drainage body with a hollow cavity and an expansion fixation device connected to the drainage body, wherein:

[0006] The drainage body is used to connect the anterior chamber of the eye with the suprachoroidal space, and includes a proximal portion and a distal portion away from the proximal portion; the shape of the expansion fixator is a two-dimensional plane shape or a three-dimensional solid shape, and the expansion fixator has a first end and a second end, the first end is connected to the proximal portion of the drainage body, and the second end is connected to the distal portion of the drainage body;

[0007] The proximal portion of the drainage body is the end close to the suprachoroidal space, and its length is 0.2-2.5 mm. The distal portion of the drainage body is the end close to the anterior chamber of the eye, and its length is 0.5-3.0 mm.

[0008] The ophthalmic minimally invasive drainage device with expansion and fixation function of the present invention is prepared by using a drainage body with a hollow cavity, which can meet the requirements of loading and implantation; after being released, it returns to a preset shape, and while playing a drainage role, the expansion fixator can prevent slippage and enhance the fixation effect in the eye, thereby realizing the expansion and fixation function of the ophthalmic minimally invasive drainage device. In addition, the expansion fixator deployed in the supraciliary cavity can achieve a certain degree of ciliary dissociation, so that the aqueous humor drained from the anterior chamber enters the supraciliary choroidal cavity, and then is absorbed by the sclera or ciliary choroidal blood vessels; at the same time, the ciliary dissociation caused by the expansion fixator can inhibit the secretion of aqueous humor by the ciliary non-pigmented epithelial cells, further reducing intraocular pressure.

[0009] Optionally, the ophthalmic minimally invasive drainage device with expansion and fixation function is made of nickel-titanium shape memory alloy material;

[0010] The drainage body and the expansion fixator are formed in one piece or in a split combination;

[0011] The outer diameter of the drainage body is 0.15-0.6 mm; the inner diameter of the drainage body is 0.05-0.4 mm.

[0012] Optionally, the shape of the expansion fixator is a two-dimensional plane; wherein the expansion fixator includes two expansion ribs symmetrically arranged about the axial direction of the drainage body, for example, the expansion fixator is two expansion ribs parallel to the axial direction of the drainage body and distributed at an angle of 180°; and the two-dimensional expansion plane formed by the two expansion ribs has a first expansion diameter, and the first expansion diameter is 0.6-2.0mm; preferably, the first expansion diameter is 0.8-1.5mm. The expansion fixator can be an integral part with the drainage body, or it can be formed as a combination with the drainage body, and the combination method includes welding or bonding with biocompatible glue.

[0013] Optionally, the drainage body can be a drainage tube with an inner cavity; the first end and the second end of the expansion fixer are respectively mounted on the outer wall of the drainage tube, and any one of the first end and the second end is fixedly connected to the outer wall of the drainage tube, and the other end is a free sliding end.

[0014] Optionally, the shape of the expansion fixator is a three-dimensional solid shape; the expansion fixator comprises n expansion ribs, wherein n is an integer greater than 2, preferably, n is 3 or 4;

[0015] The n expansion ribs are arranged to be evenly spaced along the circumference of the drainage body. For example, the expansion ribs are n expansion ribs evenly distributed at an angle of 360° / n, and the expansion ribs are arranged along an axial direction parallel to the drainage body; or, the expansion ribs are arranged in a spiral form along the axial direction of the drainage body.

[0016] Optionally, the expansion fixator includes three expansion ribs evenly arranged along the circumference of the drainage body, and the three-dimensional expansion structure composed of the three expansion ribs has a second expansion diameter, and the second expansion diameter is 0.4-1.2mm; preferably, the second expansion diameter is 0.6-0.8mm; the expansion fixator can be an integral part with the drainage body, and can also be composed of the drainage body as a combination, and the combination method includes welding or bonding with biocompatible glue.

[0017] Optionally, the length of the two-dimensional planar expander is 0.9-2.2 mm, preferably 1.0-1.8 mm; or the length of the three-dimensional expander is 0.8-1.8 mm, preferably 1.0-1.5 mm; preferably, the two-dimensional planar expander or the three-dimensional expander is configured to dissociate the ciliary body so that the aqueous humor drained from the anterior chamber enters the ciliary choroidal space and is then absorbed through the sclera or ciliary choroidal blood vessels.

[0018] The present invention provides a delivery system for delivering the ophthalmic minimally invasive drainage device with expansion and fixation function of the present invention, the delivery system comprising a puncture needle, a needle seat, a shell, an ejector pin, a tail seat, a button and a spring;

[0019] The puncture needle is fixedly connected to the needle seat, and the needle seat is arranged in the shell and can move forward and backward relative to the shell; the puncture needle includes a first cylindrical inner cavity for loading the ophthalmic minimally invasive drainage device with expansion and fixing function; the ophthalmic minimally invasive drainage device can be elastically compressed and loaded into the first cylindrical inner cavity; the puncture needle is arranged at the front end of the shell, and at least a part of the puncture needle is inserted into the shell;

[0020] The button is connected to the needle seat and cooperates with the housing; the spring is arranged between the button and the needle seat; the button can push the needle seat to move forward and backward relative to the housing;

[0021] The ejector pin is fixedly connected to the tail stock, the outer diameter of the ejector pin is slidably matched with the inner diameter of the puncture needle, the ejector pin is used to support the ophthalmic minimally invasive drainage device with expansion and fixing functions, and the tail stock is fixedly connected to the shell.

[0022] Optionally, the button and the housing have a first state and a second state; in the first state, the button and the housing form a limit to prevent the needle seat from moving; in the second state, the button releases the limit relationship with the housing.

[0023] Optionally, the tailstock includes a blind hole that cooperates with the ejector pin and a first locking structure that cooperates with the shell and is fixed thereto, the first locking structure is a threaded structure or a snap-fit ​​structure, and the tailstock is fixedly connected to the shell via the first locking structure;

[0024] The puncture needle is made of stainless steel or nickel-titanium shape memory alloy, the needle seat, shell, tail seat and button are made of resin, and the ejector pin and the spring are made of stainless steel.

[0025] Optionally, the shell includes a second cylindrical inner cavity that slides with the puncture needle, a shell inner cavity that slides with the outer surface of the needle seat, a first shell inner cavity surface and a second shell inner cavity surface that slide with the outer surface of the button, and a second locking structure that cooperates with the first locking structure.

[0026] Optionally, the needle seat has a third cylindrical inner cavity with the same axis as the puncture needle and slidingly matched with the ejector pin, the needle seat has a rectangular outer surface that slides with the inner cavity of the shell, the needle seat has a first needle seat inner cavity surface and a second needle seat inner cavity surface that slides with the outer surface of the button, the first needle seat inner cavity surface and the second needle seat inner cavity surface are arranged to form a button installation cavity, the needle seat has a cylinder that is fixedly matched with the inner surface of the spring, and the cylinder is arranged in the button installation cavity.

[0027] Optionally, the button includes a second button outer surface slidably matched with the inner cavity surface of the first needle seat, a first button outer surface slidably matched with the inner cavity surface of the second needle seat, a third button outer surface slidably matched with the inner cavity surface of the first shell, a fourth button outer surface slidably matched with the inner cavity surface of the second shell, and a button inner cavity surface fixedly matched with the spring;

[0028] The width of the inner cavity surface of the first shell is greater than the width of the inner cavity surface of the second shell, and the diameter of the outer surface of the second button is greater than the width of the inner cavity surface of the second shell, so that in the first state, the inner cavity of the second shell faces the outer surface of the second button to form a locking limit;

[0029] The diameter of the outer surface of the fourth button is smaller than the diameter of the outer surface of the second button, and smaller than or equal to the width of the inner cavity surface of the second shell, so that the outer surface of the fourth button can slide relatively along the inner cavity surface of the second shell in the second state.

[0030] Optionally, the outer diameter of the puncture needle is 0.4-0.8 mm, the inner diameter of the puncture needle is 0.18-0.61 mm, and the puncture needle is a round blunt needle;

[0031] The spring comprises an outer spring surface fixedly matched with the inner cavity surface of the button and an inner spring surface fixedly matched with the outer surface of the cylinder of the needle seat.

[0032] Additional aspects and advantages of the present invention will be set forth in part in the description which follows and, in part, will be obvious from the description which follows, or may be learned by practice of the invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] The accompanying drawings herein are incorporated into and constitute a part of the specification, illustrate embodiments consistent with the present invention, and together with the description are used to explain the principles of the present invention. In the accompanying drawings, the same components use the same figure marks, and the accompanying drawings are not in actual proportion.

[0034] Figure 1A is a schematic structural diagram of a drainage device with a two-dimensional planar expansion fixator in one embodiment of the present invention;

[0035] Figure 1B is a schematic structural diagram of a drainage device with a two-dimensional planar expansion fixator in another embodiment of the present invention;

[0036] Figure 2 It is a structural schematic diagram of a drainage device with a three-dimensional expansion fixator in another embodiment of the present invention;

[0037] Figure 3 is a schematic structural diagram of a drainage device with a three-dimensional expansion fixator in another embodiment of the present invention;

[0038] Figure 4 is a schematic structural diagram of a puncture needle and a needle holder of a delivery system in one embodiment of the present invention;

[0039] Figure 5 is a schematic diagram of the structure of the housing of the delivery system in one embodiment of the present invention;

[0040] Figure 6 is a schematic diagram of the structure of the ejector pin and tailstock of the delivery system in one embodiment of the present invention;

[0041] Figure 7 is a schematic diagram of a button of a delivery system according to an embodiment of the present invention;

[0042] Figure 8 is a schematic diagram of the structure of a spring of a delivery system in one embodiment of the present invention;

[0043] Fig. 9 is a schematic diagram of the assembly relationship of the delivery system in one embodiment of the present invention;

[0044] Fig.10 is a schematic diagram of the assembly of a drainage device and a delivery system in one embodiment of the present invention;

[0045] Fig.11A is a schematic diagram of the coordination relationship between the drainage device and the components of the delivery system in the initial state in one embodiment of the present invention;

[0046] Fig. 11B is a schematic diagram of the coordination relationship between the drainage device and the delivery system components in the startup state (pressing the button) in one embodiment of the present invention;

[0047] Fig. 11C It is a schematic diagram of the coordination relationship of the components during the release process of the drainage device in one embodiment of the present invention;

[0048] Fig.11D It is a schematic diagram of the coordination relationship of the components of the flow diverter in the release completion state according to one embodiment of the present invention;

[0049] Fig. 12A is a schematic diagram of injecting a viscoelastic agent into the suprachoroidal space in one embodiment of the present invention;

[0050] Fig. 12B is a schematic diagram of the position of the drainage device during implantation in one embodiment of the present invention;

[0051] Fig. 12C is a schematic diagram of the drainage device being released in one embodiment of the present invention;

[0052] Fig.12D is a schematic diagram of a completed drainage device implantation in one embodiment of the present invention;

[0053] Fig.13 This is an AS-OCT image of a rabbit eye implanted with a drainage device according to an embodiment of the present invention for one month.

[0054] Reference numerals:

[0055] 100-Drainer with two-dimensional planar expansion fixator;

[0056] 200-Drainage device with three-dimensional expansion fixator;

[0057] 110, 210-distal end of the drainage body; 130, 230-proximal end of the drainage body; 140, 240-hollow inner cavity of the drainage body; 121, 122-first expansion ribs in a two-dimensional plane;

[0058] 150 - a second expansion fixer in a two-dimensional plane shape; 151, 152 - a second expansion rib in a two-dimensional plane shape;

[0059] 221, 222, 223-third expansion ribs of three-dimensional shape;

[0060] 224, 225, 226-fourth expansion rib of three-dimensional shape;

[0061] 300-delivery system;

[0062] 310 - puncture needle; 311 - first cylindrical inner cavity;

[0063] 320-needle seat; 321-third cylindrical inner cavity; 322-rectangular outer surface; 323-first needle seat inner cavity surface, 324-second needle seat inner cavity surface; 325-cylinder;

[0064] 330-housing; 331-second cylindrical inner cavity, 332-housing inner cavity, 333-first housing inner cavity surface, 334-second housing inner cavity surface; 335-second locking structure;

[0065] 340-thimble;

[0066] 350-tailstock; 351-blind hole; 352-first locking structure;

[0067] 360 - button; 361 - first button outer surface; 362 - second button outer surface; 363 - third button outer surface; 364 - fourth button outer surface; 365 - button inner cavity surface;

[0068] 370 - spring; 371 - outer surface of spring; 372 - inner surface of spring. DETAILED DESCRIPTION

[0069] The technical scheme of the present invention will be further described in detail below in conjunction with specific embodiments. It should be understood that the following embodiments are only exemplary descriptions and explanations of the present invention and should not be construed as limiting the scope of protection of the present invention. All technologies implemented based on the above content of the present invention are included in the scope that the present invention is intended to protect.

[0070] Based on the problems of poor fixation effect and difficulty in processing of current drain devices and the risks of current external surgical methods, the present invention provides a brand-new ophthalmic minimally invasive drain with expansion and fixation function, which is protected by a suprachoroidal viscoelastic sheath and implanted externally in the suprachoroidal space, and its delivery system.

[0071] This embodiment first provides an ophthalmic minimally invasive drainage device with expansion and fixation functions, see FIG. Figure 3 The ophthalmic minimally invasive drainage device is a drainage body having a hollow cavity (140, 240), wherein the hollow cavity (140, 240) is a passage for aqueous humor to flow from the anterior chamber into the suprachoroidal space, and the drainage body comprises a proximal portion (130, 230) and a distal portion (110, 210) away from the proximal portion, wherein the end of the drainage body entering the anterior chamber of the eye is the distal portion (110, 210), and the end in the suprachoroidal space is the proximal portion (130, 230); the ophthalmic minimally invasive drainage device having an expansion and fixation function is also provided with an expansion fixator capable of enhancing the fixation effect in the eye and having a ciliary body dissociation function, wherein the expansion fixator can be an integral part with the drainage body, or can be a combined part (150) with the drainage body, and the combination method includes welding or bonding with biocompatible glue.

[0072] The shape of the expansion fixator is a two-dimensional plane shape or a three-dimensional solid shape. The two-dimensional plane expansion fixator has a first end and a second end, the first end is connected to the proximal end (130, 230) of the drainage body, and the second end is connected to the distal end (110, 210) of the drainage body. Exemplarily, the expansion fixator includes two expansion ribs (121, 122, 151, 152) that are symmetrically distributed and parallel to the axial direction of the drainage body and are integral with the drainage body, such as the first expansion rib (121, 122) or the second expansion rib (151, 152); the expansion fixator may also include n expansion ribs (221, 222, 223, 224, 225, 226) evenly spaced along the circumference of the drainage body. Specifically, the expansion fixator may have n expansion ribs evenly distributed at an angle of 360° / n along the circumference of the drainage body, where n is an integer, preferably, n is 3 or 4. Among them, the expansion fixator may include third expansion ribs (221, 222, 223) uniformly arranged along the axial direction parallel to the drainage body, and may also include fourth expansion ribs (224, 225, 226) distributed in a spiral shape along the axial direction of the drainage body. The above-mentioned drain device is squeezed into the suprachoroidal space and eye tissue, which can enhance the fixation effect of the implanter in the eye. The drain device with a preset two-dimensional plane shape or three-dimensional stereoscopic shape can be compressed and loaded into the puncture needle of the delivery system, and can restore the preset shape after being released and implanted into the eye, and then fixed in the release position.

[0073] In some embodiments, the ophthalmic minimally invasive drainage device is made of nickel-titanium shape memory alloy, and the drainage body and the expansion fixator are formed in one piece or in a split combination.

[0074] The drainage device made of nickel-titanium shape memory alloy can connect the anterior chamber and the suprachoroidal space, and play the role of drainage device; at the same time, it can meet the requirements of linear compression, and thus can meet the requirements of loading and implantation; after being released, it returns to the preset shape, and while playing the role of drainage, the preset shape with a specific structure can prevent slippage and enhance the fixation effect in the eye. In addition, the expansion fixator deployed in the supraciliary cavity can achieve a certain degree of ciliary body dissociation, so that the aqueous humor drained from the anterior chamber enters the supraciliary choroidal space, and then is absorbed by the sclera or ciliary choroidal blood vessels; at the same time, the ciliary body dissociation caused by the expansion fixator can inhibit the secretion of aqueous humor by the ciliary non-pigmented epithelial cells, further reducing intraocular pressure.

[0075] Preferably, the outer diameter of the drainage body of the ophthalmic minimally invasive drainage device is 0.15-0.6mm; the inner diameter of the drainage body is 0.05-0.4mm; the total length of the ophthalmic minimally invasive drainage device is 2.5-7.0mm; the length of the distal portion of the drainage body of the ophthalmic minimally invasive drainage device entering the anterior chamber of the eye is 0.5-3.0mm; the length of the proximal portion of the drainage body of the ophthalmic minimally invasive drainage device at the suprachoroidal space is 0.2-2.5mm.

[0076] Reference Figure 1A , Figure 1B A drainage device (100) with a two-dimensional planar expansion fixator, wherein the expansion fixator is composed of two expansion ribs (121, 122, 151, 152) symmetrically arranged about the axis of the drainage body, and the expansion fixator can be an integral part with the drainage body ( Figure 1A ), or it can be combined with the drainage body ( Figure 1B ). Two expansion ribs can form a preset two-dimensional expansion plane, which has a first expansion diameter, and the first expansion diameter is 0.6-2.0 mm; preferably, the first expansion diameter is 0.8-1.5 mm. It should be noted that the first expansion diameter and the second expansion diameter described below refer to the diameter of the circumscribed circle formed by the expansion rib after the expansion rib is expanded in a direction perpendicular to the axial direction of the drainage body.

[0077] When it is a split assembly (refer to Figure 1B ), the drainage body and the expansion fixture are independent components, which can be assembled to form an assembly (150). For example, the drainage body can be a drainage tube with an inner cavity, the first end and the second end of the expansion fixture are respectively sleeved on the outer wall of the drainage tube, and any one of the first end and the second end is fixedly connected to the outer wall of the drainage tube, for example, a laser welding machine is used to spot weld any one end of the expansion fixture to the drainage tube, and the other end is a free sliding end, which can slide freely on the drainage tube.

[0078] See also Figure 2 , Figure 3 A drainage device (200) with a three-dimensional expansion fixator, wherein the expansion fixator is composed of three expansion ribs evenly arranged along the circumference of the drainage body, such as three third expansion ribs (221, 222, 223) or fourth expansion ribs (224, 225, 226) evenly distributed at an angle of 120°, and the third expansion ribs (221, 222, 223) can be parallel to the axial direction of the drainage body ( Figure 2 ), the fourth expansion ribs (224, 225, 226) may also be distributed in a spiral shape relative to the axial direction of the drainage body ( Figure 3The expansion fixator can be an integral part with the drainage body, or a combined part with the drainage body. The three-dimensional expansion structure composed of three expansion ribs in this embodiment has a second expansion diameter, which can be 0.4-1.2 mm; preferably, the second expansion diameter is 0.6-0.8 mm.

[0079] According to one embodiment, the length of the two-dimensional planar expansion fixator is 0.9-2.2 mm, preferably 1.0-1.8 mm; or the length of the three-dimensional expansion fixator is 0.8-1.8 mm, preferably 1.0-1.5 mm.

[0080] This embodiment further provides a delivery system for delivering the ophthalmic minimally invasive drainage device in any of the above embodiments, see Figure 4-Figure 10 The delivery system mainly includes a puncture needle 310, a needle seat 320, a shell 330, a thimble 340, a tail seat 350, a button 360 and a spring 370; wherein the puncture needle 310 is fixedly connected to the needle seat 320, and the puncture needle 310 includes a first cylindrical inner cavity 311 for loading an ophthalmic minimally invasive drainage device; the ophthalmic minimally invasive drainage device can be elastically compressed and loaded into the first cylindrical inner cavity 311 of the puncture needle; the puncture needle 310 is arranged at the front end of the shell 330, and a part of the puncture needle 310 is inserted into the shell 330; the needle The seat 320 is arranged in the shell 330 and can move forward and backward relative to the shell 330; the button 360 is connected to the needle seat 320 and cooperates with the shell 330; the spring 370 is arranged between the button 360 and the needle seat 320; the button 360 can push the needle seat 320 to move forward and backward relative to the shell 330; the ejector pin 340 is fixedly connected to the tail seat 350, and the outer diameter of the ejector pin 340 is slidably matched with the inner diameter of the puncture needle 310. The ejector pin 340 is used to support the minimally invasive ophthalmic drainage device, and the tail seat 350 is fixedly connected to the shell 330.

[0081] In order to meet the implantation requirements, the drain made of nickel-titanium shape memory alloy material can be linearly compressed. One solution is to completely compress its expansion fixator and install it into the rigid puncture needle 310. The length of the distal end of the drainage body exposed from the puncture needle 310 is 0.5-3.0 mm. Before the drainage device is implanted, it is stretched open by injecting viscoelastic into the suprachoroidal space to facilitate the puncture and positioning of the puncture needle 310. As part of the delivery system, the puncture needle 310 enters the suprachoroidal space until the distal end of the drainage body of the drain device passes through the anterior chamber angle by 0.3-1.0 mm. After the puncture needle is withdrawn, the drain is released in situ, and then the delivery system is withdrawn as a whole to complete the implantation process of the drain device.

[0082] In some embodiments, the button 360 and the housing 330 have a first state and a second state; in the first state, the button 360 and the housing 330 form a limit to prevent the needle seat 320 from moving; in the second state, the button 360 releases the limit relationship with the housing 330.

[0083] See also Figure 6 The tail stock 350 includes a blind hole 351 which cooperates with the ejector pin 340 and a first locking structure 352 which cooperates with the shell 330 and is fixed thereto. The first locking structure 352 is a threaded structure or a snap-fit ​​structure. The tail stock 350 and the shell 330 are fixedly connected via the first locking structure 352. The puncture needle 310 is made of stainless steel or nickel-titanium shape memory alloy. The needle stock 350, the shell 330, the tail stock 350 and the button 360 are made of resin. The ejector pin 340 and the spring 370 are made of stainless steel.

[0084] See also Figure 5 The housing 330 includes a second cylindrical inner cavity 331 that is slidably matched with the puncture needle 310, a housing inner cavity 332 that is slidably matched with the outer surface of the needle seat 320, a first housing inner cavity surface 333 and a second housing inner cavity surface 334 that are slidably matched with the outer surface of the button 360, and a second locking structure 335 that is matched with the first locking structure 352. The second locking structure 335 can be a threaded structure or a buckle structure, as long as it can be fixedly connected with the first locking structure 352. The housing inner cavity 332 can be a rectangular inner cavity.

[0085] The width of the first shell inner cavity surface 333 is greater than the width of the second shell inner cavity surface 334, and the diameter of the second button outer surface 361 is greater than the width of the second shell inner cavity surface 334, so that the second shell inner cavity surface 334 forms a restriction on the second button outer surface 361 in the first state.

[0086] Furthermore, the diameter of the fourth button outer surface 364 is smaller than the diameter of the second button outer surface 362 and smaller than or equal to the width of the second shell inner cavity surface 334, so that the fourth button outer surface 364 can slide along the second shell inner cavity surface 334 in the second state.

[0087] See also Figure 4 The needle seat 320 has a third cylindrical inner cavity 321 which is axially the same as the puncture needle 310 and slides with the ejector pin 340. The needle seat 320 has a rectangular outer surface 322 which slides with the inner cavity of the shell. The needle seat 320 has a first needle seat inner cavity surface 323 and a second needle seat inner cavity surface 324 which slide with the outer surface of the button 360. The first needle seat inner cavity surface 323 and the second needle seat inner cavity surface 324 are arranged to form a button installation cavity. The needle seat 320 has a cylinder 325 which is fixedly matched with the inner surface of the spring 370, and the cylinder 325 is located in the button installation cavity.

[0088] See also Figure 7 The button 360 includes a second button outer surface 361 that is slidably matched with the first needle seat inner cavity surface 323, a first button outer surface 362 that is slidably matched with the second needle seat inner cavity surface 324, a third button outer surface 363 that is slidably matched with the first shell inner cavity surface 333, a fourth button outer surface 364 that is slidably matched with the second shell inner cavity surface 334, and a button inner cavity surface 365 that is fixedly matched with the outer surface of the spring 370. The diameter of the fourth button outer surface 364 is smaller than the diameter of the second button outer surface 361, and can slide along the second shell inner cavity surface 334.

[0089] In some embodiments, the outer diameter of the puncture needle 310 is 0.4-0.8 mm, the inner diameter of the puncture needle 310 is 0.18-0.61 mm, and the needle tip of the puncture needle 310 is a rounded blunt needle.

[0090] See also Figure 8 The spring 370 has a spring outer surface 371 fixedly matched with the button inner cavity surface 365 and a spring inner surface 372 fixedly matched with the outer surface of the cylinder 325 of the needle seat 320.

[0091] During the assembly process, after the needle seat 320 is installed into the inner cavity 332 of the shell, the inner surface 372 of the spring is fixedly matched with the cylinder 325 of the needle seat, and the outer surface 371 of the spring is fixedly matched with the inner cavity surface 365 of the button. The second outer surface 362 of the button 360 passes through the first inner cavity surface 333 of the shell 330 through interference fit, so that the first inner cavity surface 323 of the needle seat is matched with the second outer surface 362 of the button. At the same time, under the support of the elastic force of the spring 370, the first inner cavity surface 333 of the shell is matched with the third outer surface 363 of the button. Since the width of the second inner cavity surface 334 of the shell is smaller than that of the first inner cavity surface 333 of the shell and cannot be adapted to the third outer surface 363 of the button, a limiting connection is formed between the button 360 and the shell 330, and between the button 360 and the needle seat 320 ( Fig. 9 , Fig.11A ).

[0092] See also Fig.10 After the drain device is loaded into the first cylindrical inner cavity 311 of the puncture needle 310, the assembly of the drain device and the delivery system is completed.

[0093] See also Fig.11A , the limiting connection between the button 360 and the housing 330, and between the button 360 and the needle seat 320 is in the initial state (ie, the first state). Fig. 11B By pressing the button 360, the first housing inner cavity surface 333 and the third button outer surface 363 are released from the match, and the assembly enters the start state (ie, the second state). Fig. 11CThe retraction button 360 realizes the sliding cooperation between the second shell inner cavity surface 334 and the fourth button outer surface 364. The retraction movement of the button 360 drives the needle seat 320 to retract, and also realizes the retraction of the puncture needle 310. At the same time, the position of the ejector pin 340 remains unchanged, so the ejector pin 340 pushes the drainage device out of the puncture needle 310, thereby realizing the in-situ release of the drainage device. Fig.11D After the force on the button 360 is removed, the delivery system can be stabilized in a state where the drainage device is released.

[0094] Drainage device implantation is a new external route implantation method based on the protection of suprachoroidal viscoelastic sheath. The implantation steps are as follows:

[0095] (1) Cut the bulbar conjunctiva about 4 mm behind the corneoscleral limbus, with a diameter of about 4 mm;

[0096] (2) See Fig. 12A , use a syringe or a dedicated device (such as a suprachoroidal syringe) to inject viscoelastic (about 70 μl / eye) 4 mm behind the corneoscleral limbus;

[0097] (3) See Fig. 12B , the puncture needle of the delivery system punctures into the suprachoroidal space obliquely (at a tangential angle of about 10-15° to the scleral surface) until the distal end of the drain penetrates the anterior chamber angle by about 0.5 mm;

[0098] (4) See Fig. 12C , press the button and then withdraw, releasing the drain in situ;

[0099] (5) See Fig.12D , remove the puncture needle and complete the implantation of the drainage device;

[0100] (6) Press the puncture site to stop bleeding and allow the puncture site to close on its own (if the puncture site does not close on its own, close the incision with 10-0 sutures).

[0101] The present embodiment continues to provide the following examples according to specific experiments.

[0102] Embodiment 1

[0103] Two hollow structures were laser engraved on a nickel-titanium shape memory alloy tube with an outer diameter of 0.2 mm and an inner diameter of 0.1 mm, thereby forming two ribs. The circumferential width of the ribs and the spacing between the ribs were both 1 / 4 of the circumference of the tube. The length of the ribs was 2.0 mm. The ribs were cut at 0.5 mm and 2.5 mm at both ends, respectively, to obtain a 5.0 mm long drain material. A stainless steel wire with an outer diameter of 1.1 mm was inserted into the hollow structure to support the expansion of two ribs, and then placed under heat treatment at 500°C for 15 minutes and then water-cooled and quenched. After removing the stainless steel wire, a two-dimensional planar expansion fixture pipe fitting with two expansion ribs was obtained. The expansion fixture pipe fitting was pickled in a pickling solution with hydrofluoric acid and nitric acid as the main components to remove the oxide scale formed during the heat treatment process, and then electrochemically polished using an electrochemical workstation in a polishing solution with glacial acetic acid, ethanol, ethylene glycol and perchloric acid as the main components, and then washed to obtain a drain with a two-dimensional planar expansion fixture, wherein the two-dimensional planar expansion fixture and the drainage body are an integral part, the outer diameter of the drainage body of the drain is 0.2 mm, the inner diameter of the drainage body is 0.1 mm, the total length is 4.6 mm, the distal length is 2.5 mm, the proximal length is 0.5 mm, and the expansion diameter of the expansion fixture is 1.2 mm. The drain has good elasticity and a phase transition temperature of 28°C.

[0104] The drainage device in this embodiment can be released in situ in the eye using the delivery system in this embodiment. The puncture needle in the delivery system selects a 25G normal wall needle tube (outer diameter 0.50mm, inner diameter 0.24mm), and the needle tip is a rounded blunt needle; the length of the puncture needle beyond the shell in the initial state is 6mm, and the length of the puncture needle beyond the shell in the terminal state (puncture needle withdrawal, drainage device implantation is completed) is 1mm, that is, the maximum length of the button withdrawal is 5mm; the outer diameter of the ejector in the delivery system is 0.20mm, and the length of the ejector beyond the shell is 2mm; the total length of the delivery system is 100mm, and the maximum outer diameter is 22mm.

[0105] Use a 25G normal wall needle (outer diameter 0.50mm, inner diameter 0.24mm) to push the drain into the conical fixture, compress the expansion fixture, and move it in the desired direction ( Fig.11A , Fig.11D ) is inserted into the puncture needle. The distal end of the assembled drain protrudes 1.0 mm from the puncture needle, and the drain can maintain a relative position with the puncture needle when no external force is applied.

[0106] After cleaning and sterilization, the drainage device and delivery system were implanted into the rabbit eye according to the operation steps. During the operation, the delivery system functioned normally, the operation was convenient, and the positioning was accurate. The drainage device was successfully implanted in the expected position. The results of the 1-month follow-up showed that the drainage function of the drainage device was normal and the tissue biocompatibility was good; the AS-OCT image of the 1-month follow-up ( Fig.13) showed that the drain did not move and the ciliary body dissociation effect of the dilator was obvious.

[0107] Embodiment 2

[0108] Two hollow structures were laser engraved on a nickel-titanium shape memory alloy tube with an outer diameter of 0.3mm and an inner diameter of 0.2mm, thereby forming two ribs. The circumferential width of the ribs and the spacing between the ribs are both 1 / 4 of the circumference of the tube. The length of the ribs is 2.0mm. The ribs are cut at 0.30mm at both ends to obtain a fixed structure raw material with a length of 2.6mm. A stainless steel wire with an outer diameter of 1.1mm is inserted into the hollow structure to support the expansion of two expansion ribs. After heat treatment at 500℃ for 15min, it is water-cooled and quenched. After removing the stainless steel wire, a two-dimensional planar expansion fixture with two expansion ribs is obtained. The total length of the expansion fixture is 2.2mm and the expansion diameter is 1.2mm.

[0109] Take a nickel-titanium shape memory alloy pipe with an outer diameter of 0.2 mm and an inner diameter of 0.1 mm, cut it into a short section with a length of 4.5 mm as the drainage body of the drain, insert it into the inner cavity of the above-mentioned two-dimensional planar expansion fixator, and adjust the length of the distal end to 2.0 mm (that is, the distance between the drainage body and the end of the fixator is 1.7 mm). Use a laser welding machine to spot weld at either end of the expansion fixator (the other end is a free state where the fixator can slide freely on the drainage body) to obtain a combination of the drainage body and the fixator. The assembly is pickled in a pickling solution with hydrofluoric acid and nitric acid as main components to remove the oxide scale formed during heat treatment and welding, and then electrochemically polished using an electrochemical workstation in a polishing solution with glacial acetic acid, ethanol, ethylene glycol and perchloric acid as main components. After cleaning, a drain with a two-dimensional planar expansion fixture is obtained, wherein the two-dimensional planar expansion fixture and the drainage body are an assembly, the outer diameter of the drainage body of the drainer is 0.2mm, the inner diameter of the drainage body is 0.1mm, the total length is 4.5mm, the distal end length is 2.0mm, the proximal end length is 0.9mm, the expansion diameter of the expansion fixture is 1.2mm, and the drain has good elasticity.

[0110] The drainage device in this embodiment can be released in situ in the eye using the delivery system in this embodiment. The puncture needle in the delivery system is a 23G thin-walled needle tube (outer diameter 0.60mm, inner diameter 0.37mm), and the needle tip is a rounded blunt needle; the length of the puncture needle beyond the shell in the initial state is 5mm, and the length of the puncture needle beyond the shell in the terminal state (puncture needle withdrawal, drainage device implantation completed) is 1mm, that is, the maximum length of the button withdrawal is 4mm; the outer diameter of the ejector in the delivery system is 0.30mm, and the length of the ejector beyond the shell is 2mm; the total length of the delivery system is 100mm, and the maximum outer diameter is 22mm.

[0111] Use a 25G normal wall needle (outer diameter 0.50mm, inner diameter 0.24mm) to push the drain into the conical fixture, compress the fixture, and move it in the desired direction ( Fig.11A , Fig.11D ) is inserted into the puncture needle. The distal end of the assembled drain protrudes 1.5 mm from the puncture needle, and the drain can maintain a relative position with the puncture needle when no external force is applied.

[0112] After cleaning and sterilization, the drainage device and delivery system were implanted into the rabbit eye according to the operation steps. During the operation, the delivery system functioned normally, the operation was convenient, and the positioning was accurate. The drainage device was successfully implanted in the expected position. The results of the one-month follow-up showed that the drainage function of the drainage device was normal, there was no positional movement, and the tissue biocompatibility was good.

[0113] Embodiment 3

[0114] Three hollow structures were laser engraved on a nickel-titanium shape memory alloy tube with an outer diameter of 0.2 mm and an inner diameter of 0.1 mm, thereby forming three ribs. The circumferential width of the ribs and the spacing between the ribs were both 1 / 6 of the circumference of the tube. The length of the ribs was 1.7 mm, and the ribs were cut at 1.0 mm and 2.0 mm at both ends, respectively, to obtain a 4.7 mm long drain material. The raw material is inserted into the mold, axially compressed by 0.2mm, expanded by 3 ribs, and then fixed. It is placed at 500℃ for heat treatment for 15min and then water-cooled and quenched. After removing the mold, a three-dimensional expansion fixture pipe fitting with three expansion ribs is obtained. The pipe fitting is pickled in a pickling solution with hydrofluoric acid and nitric acid as the main components to remove the oxide scale formed during the heat treatment process, and then electrochemically polished using an electrochemical workstation in a polishing solution with glacial acetic acid, ethanol, ethylene glycol and perchloric acid as the main components. After cleaning, a drain with a three-dimensional expansion fixture is obtained, wherein the three-dimensional expansion fixture is an integral part with the drainage body, the outer diameter of the drainage body of the drain is 0.2mm, the inner diameter of the drainage body is 0.1mm, the total length is 4.5mm, the distal length is 2.0mm, the proximal length is 1.0mm, and the expansion diameter of the expansion fixture is 0.8mm. The drain has good elasticity and a phase transition temperature of 28℃.

[0115] The drainage device in this embodiment can be released in situ in the eye using the delivery system in this embodiment. The puncture needle in the delivery system selects a 25G normal wall needle tube (outer diameter 0.50mm, inner diameter 0.24mm), and the needle tip is a rounded blunt needle; the length of the puncture needle beyond the shell in the initial state is 6mm, and the length of the puncture needle beyond the shell in the terminal state (puncture needle withdrawal, drainage device implantation is completed) is 1mm, that is, the maximum length of the button withdrawal is 5mm; the outer diameter of the ejector in the delivery system is 0.20mm, and the length of the ejector beyond the shell is 2mm; the total length of the delivery system is 100mm, and the maximum outer diameter is 22mm.

[0116] Use a 25G normal wall needle tube (outer diameter 0.50mm, inner diameter 0.24mm) to push the drain in the conical fixture, compress the fixture, and install it into the puncture needle in the expected direction (the distal end is outside the puncture needle). The distal end of the assembled drain protrudes 1.0mm from the puncture needle, and the drain can maintain its relative position with the puncture needle when no external force is applied.

[0117] After cleaning and sterilization, the drainage device and delivery system were implanted into the rabbit eye according to the operation steps. During the operation, the delivery system functioned normally, the operation was convenient, and the positioning was accurate. The drainage device was successfully implanted in the expected position. The results of the one-month follow-up showed that the drainage function of the drainage device was normal, there was no positional movement, and the tissue biocompatibility was good.

[0118] In the description of the present invention, it is to be understood that the terms “center”, “longitudinal”, “lateral”, “length”, “width”, “thickness”, “up”, “down”, “front”, “back”, “left”, “right”, “vertical”, “horizontal”, “top”, “bottom”, “inside”, “outside”, “clockwise”, “counterclockwise”, “axial”, “radial”, “circumferential”, etc., indicating orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as limiting the present invention.

[0119] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. In the description of the present invention, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0120] In the present invention, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral one; it can be a mechanical connection, an electrical connection, or communication with each other; it can be a direct connection, or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0121] In the present invention, unless otherwise clearly specified and limited, a first feature being "above" or "below" a second feature may mean that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediate medium. Moreover, a first feature being "above", "above" or "above" a second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. A first feature being "below", "below" or "below" a second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0122] In the present invention, the terms "one embodiment", "some embodiments", "examples", "specific examples", or "some examples" etc. mean that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the described specific features, structures, materials or characteristics may be combined in any one or more embodiments or examples in a suitable manner. In addition, those skilled in the art may combine and combine the different embodiments or examples described in this specification and the features of the different embodiments or examples, without contradiction.

[0123] Although the embodiments of the present invention have been shown and described above, it is to be understood that the above embodiments are exemplary and are not to be construed as limitations on the present invention. A person skilled in the art may change, modify, replace and modify the above embodiments within the scope of the present invention. Any modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of the present invention shall be included in the scope of protection of the present invention.

Claims

1. An ophthalmic minimally invasive drainage device with expansion and fixation function, characterized in that: The ophthalmic minimally invasive drainage device comprises a drainage body having a hollow cavity and an expansion fixer connected to the drainage body, wherein: The drainage body includes a proximal portion and a distal portion away from the proximal portion; the shape of the expansion fixator is a two-dimensional plane shape or a three-dimensional solid shape, and the expansion fixator has a first end and a second end, the first end is connected to the proximal portion of the drainage body, and the second end is connected to the distal portion of the drainage body; The proximal portion of the drainage body is the end close to the suprachoroidal space, and its length is 0.2-2.5 mm. The distal portion of the drainage body is the end close to the anterior chamber of the eye, and its length is 0.5-3.0 mm.

2. The ophthalmic minimally invasive drainage device with expansion and fixation function according to claim 1, characterized in that: The ophthalmic minimally invasive drainage device is made of nickel-titanium shape memory alloy material, and the drainage body and the expansion fixator are formed in one piece or in a split combination; The outer diameter of the drainage body is 0.15-0.6 mm; the inner diameter of the drainage body is 0.05-0.4 mm; and the total length of the ophthalmic minimally invasive drainage device is 2.5-7 mm.

3. The ophthalmic minimally invasive drainage device with expansion and fixation function according to claim 1 or 2, characterized in that: The shape of the expansion fixator is a two-dimensional plane; wherein, the expansion fixator includes two expansion ribs symmetrically arranged about the axial direction of the drainage body, and the two-dimensional expansion plane formed by the two expansion ribs has a first expansion diameter, and the first expansion diameter is 0.6-2.0mm; preferably, the first expansion diameter is 0.8-1.5mm.

4. The ophthalmic minimally invasive drainage device with expansion and fixation function according to claim 3, characterized in that: The drainage body is a drainage tube with an inner cavity; the first end and the second end of the expansion fixer are respectively sleeved on the outer wall of the drainage tube, and any one of the first end and the second end is fixedly connected to the outer wall of the drainage tube, and the other end is a free sliding end.

5. The ophthalmic minimally invasive drainage device with expansion and fixation function according to claim 1 or 2, characterized in that: The shape of the expansion fixator is three-dimensional; the expansion fixator comprises n expansion ribs, wherein n is an integer greater than 2, preferably, n is 3 or 4; The n expansion ribs are arranged to be evenly spaced along the circumference of the drainage body, and the expansion ribs are arranged in parallel to the axial direction of the drainage body; or, the expansion ribs are arranged in a spiral form along the axial direction of the drainage body.

6. The ophthalmic minimally invasive drainage device with expansion and fixation function according to claim 5, characterized in that: in, The expansion fixator comprises three expansion ribs evenly arranged along the circumference of the drainage body, and the three-dimensional expansion structure composed of the three expansion ribs has a second expansion diameter, and the second expansion diameter is 0.4-1.2mm; preferably, the second expansion diameter is 0.6-0.8mm.

7. The ophthalmic minimally invasive drainage device with expansion and fixation function according to claim 1, characterized in that: in, The length of the two-dimensional planar expansion fixture is 0.9-2.2 mm, preferably 1.0-1.8 mm; or, the length of the three-dimensional expansion fixture is 0.8-1.8 mm, preferably 1.0-1.5 mm; or, the two-dimensional planar expansion fixture or the three-dimensional expansion fixture is configured to dissociate the ciliary body so that the aqueous humor drained from the anterior chamber enters the ciliary body choroidal space and is then absorbed through the sclera or ciliary body choroidal blood vessels.

8. A delivery system for delivering the ophthalmic minimally invasive drainage device with expansion and fixation function as claimed in any one of claims 1 to 7, characterized in that: The delivery system includes a puncture needle, a needle seat, a housing, an ejector pin, a tail seat, a button and a spring; The puncture needle is fixedly connected to the needle seat, and the needle seat is arranged in the shell and can move forward and backward relative to the shell; the puncture needle includes a first cylindrical inner cavity for loading the ophthalmic minimally invasive drainage device; The ophthalmic minimally invasive drainage device can be elastically compressed and loaded into the first cylindrical inner cavity; the puncture needle is arranged at the front end of the shell, and at least a part of the puncture needle is inserted into the interior of the shell; The button is connected to the needle seat and cooperates with the housing; the spring is arranged between the button and the needle seat; the button can push the needle seat to move forward and backward relative to the housing; The ejector pin is fixedly connected to the tail stock, the outer diameter of the ejector pin is slidably matched with the inner diameter of the puncture needle, the ejector pin is used to support the ophthalmic minimally invasive drainage device with expansion and fixing functions, and the tail stock is fixedly connected to the shell.

9. The delivery system according to claim 8, characterized in that The button and the housing have a first state and a second state; in the first state, the button and the housing form a limit to prevent the needle seat from moving; in the second state, the button releases the limit relationship with the housing.

10. The delivery system according to claim 8, characterized in that The tailstock comprises a blind hole matched with the ejector pin and a first locking structure matched with the housing, wherein the first locking structure is a threaded structure or a buckle structure, and the tailstock is fixedly connected to the housing through the first locking structure; The puncture needle is made of stainless steel or nickel-titanium shape memory alloy, the needle seat, shell, tail seat and button are made of resin, and the ejector pin and the spring are made of stainless steel.

11. The delivery system according to claim 10, characterized in that The shell includes a second cylindrical inner cavity that slides with the puncture needle, a shell inner cavity that slides with the outer surface of the needle seat, a first shell inner cavity surface and a second shell inner cavity surface that slides with the outer surface of the button, and a second locking structure that cooperates with the first locking structure.

12. The delivery system according to claim 11, characterized in that The needle seat has a third cylindrical inner cavity with the same axis as the puncture needle and slidingly matched with the ejector pin. The needle seat has a rectangular outer surface that slides with the inner cavity of the shell, and a first needle seat inner cavity surface and a second needle seat inner cavity surface that slides with the outer surface of the button. The first needle seat inner cavity surface and the second needle seat inner cavity surface are arranged to form a button installation cavity. The needle seat has a cylinder that is fixedly matched with the inner surface of the spring, and the cylinder is arranged in the button installation cavity.

13. The delivery system according to claim 12, characterized in that The button comprises a second button outer surface slidably matched with the inner cavity surface of the first needle seat, a first button outer surface slidably matched with the inner cavity surface of the second needle seat, a third button outer surface slidably matched with the inner cavity surface of the first shell, a fourth button outer surface slidably matched with the inner cavity surface of the second shell, and a button inner cavity surface fixedly matched with the spring; The width of the inner cavity surface of the first shell is greater than the width of the inner cavity surface of the second shell, and the diameter of the outer surface of the second button is greater than the width of the inner cavity surface of the second shell, so that in the first state, the inner cavity of the second shell faces the outer surface of the second button to form a locking limit; The diameter of the outer surface of the fourth button is smaller than the diameter of the outer surface of the second button, and smaller than or equal to the width of the inner cavity surface of the second shell, so that the outer surface of the fourth button can slide relatively along the inner cavity surface of the second shell in the second state.

14. The delivery system according to claim 13, characterized in that The outer diameter of the puncture needle is 0.4-0.8 mm, the inner diameter of the puncture needle is 0.18-0.61 mm, and the needle tip of the puncture needle is a rounded blunt needle; The spring comprises an outer spring surface fixedly matched with the inner cavity surface of the button and an inner spring surface fixedly matched with the outer surface of the cylinder of the needle seat.

Images