An ophthalmic minimally invasive drainage implant device and its delivery system

Abstract

The present invention provides an ophthalmic minimally invasive drainage implant device and its delivery system. The ophthalmic minimally invasive drainage implant device is a pipe fitting with an inner cavity. The shape of the ophthalmic minimally invasive drainage implant device is a two-dimensional wavy shape or a three-dimensional spiral shape, and has wave crests and wave troughs. The inner cavity is used to communicate the anterior chamber of the eye with the suprachoroidal space. The outer diameter of the ophthalmic minimally invasive drainage implant device is 0.3 - 0.6 mm, and the inner diameter of the ophthalmic minimally invasive drainage implant device is 0.05 - 0.3 mm. The ophthalmic minimally invasive drainage implant device of the present invention is prepared from a pipe fitting with an inner cavity, which can meet the loading and implantation requirements. After being released, it resumes to a preset shape, which can play a role in drainage and at the same time, the preset shape with a specific structure can play a role in preventing slippage and enhancing the fixation effect in the eye.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and more particularly, to a minimally invasive ophthalmic drainage implant device and its delivery system. Background Art

[0002] MIGS (Minimally Invasive Glaucoma Surgery) is an emerging surgical procedure for treating mild to moderate glaucoma. Implanting a drainage implant device alone or in combination with cataract extraction can effectively, minimally invasively, and conveniently reduce IOP (intraocular pressure). Currently, according to the different anatomical pathways of the implant device for draining 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 pathway because the suprachoroidal space is the physiological drainage pathway of aqueous humor, has a large space, and the operation does not form a filtration bleb. Currently, the MIGS drainage implant devices for suprachoroidal drainage can be divided into trans-inner and trans-outer approaches according to the implantation method. Representative implant devices for the trans-inner approach include Cypass, iStentSupra, MiniJect, etc., and representative implant devices for the trans-outer approach include Slox Gold shunt, Aquashunt, STARflo, etc. The above methods can effectively reduce the IOP of glaucoma patients. However, the trans-inner approach requires simultaneous operation with cataract surgery, and there is a risk of displacement and shedding of the drainage implant device after surgery, resulting in damage to intraocular tissues. The trans-outer approach has a large surgical trauma, and serious complications such as explosive suprachoroidal hemorrhage may occur during the perioperative period, and the fibrosis of the inner drainage area is obvious. The above factors limit the clinical application of MIGS for suprachoroidal drainage.

[0003] Most of the suprachoroidal drainage implant devices are non-metallic pipe fittings with a lumen, such as Cypass is made of polyimide. Due to the extrusion processing characteristics of the pipe fittings, the pipe fittings have fixed inner and outer diameter parameters and a fixed axial direction, which makes it easy for the pipe fittings to slip in the suprachoroidal space after implantation, affecting the drainage effect. Therefore, in the pipe fitting drainage implant device solution, a structure for increasing the fixing effect of the pipe fittings (such as the ring with an increased outer diameter set in Cypass) will be set. However, due to the limitation of the overall small size of the pipe fittings (such as the outer diameter of Cypass is 0.40 mm and the inner diameter is 0.30 mm), the processing of the fixing structure is difficult. Summary of the Invention

[0004] The inventors of this case have found through research that nickel-titanium shape memory alloy (nickel mass fraction is 54.5%-57.0%) is a kind of shape memory alloy. Nickel-titanium shape memory alloy materials have good biocompatibility and excellent shape memory characteristics and are currently widely used in intravascular implant devices, such as intravascular stents, filters, etc. However, its application as a MIGS drainage implant device is less. Hydrus Microstent made of nickel-titanium shape memory alloy is a product for Schlemm's canal drainage method. The successful application of Hydrus Microstent indicates that nickel-titanium shape memory alloy materials can be successfully applied to ophthalmic drainage implant devices.

[0005] The present invention aims to solve at least one of the technical problems in the related art to some extent. For this reason, the present invention provides an ophthalmic minimally invasive drainage implant device. The ophthalmic minimally invasive drainage implant device is a pipe fitting with an inner cavity. The shape of the ophthalmic minimally invasive drainage implant device is a two-dimensional wave shape or a three-dimensional spiral shape and has wave crests and wave troughs; the inner cavity is used to communicate the anterior chamber of the eye with the suprachoroidal space; the outer diameter of the ophthalmic minimally invasive drainage implant device is 0.3-0.6 mm, and the inner diameter of the ophthalmic minimally invasive drainage implant device is 0.05-0.3 mm.

[0006] The ophthalmic minimally invasive drainage implant device of the present invention is prepared by using a pipe fitting with an inner cavity, which can meet the loading and implantation requirements; after it is released, it returns to the preset shape. While playing a drainage role, the preset shape with a specific structure can play a role in preventing slippage and enhancing the fixation effect in the eye.

[0007] Optionally, the ophthalmic minimally invasive drainage implant device is made of nickel-titanium shape memory alloy material;

[0008] The outer diameter of the ophthalmic minimally invasive drainage implant device is 0.3-0.4 mm; the inner diameter of the ophthalmic minimally invasive drainage implant device is 0.10-0.20 mm.

[0009] Optionally, the shape of the ophthalmic minimally invasive drainage implant device is a two-dimensional wave shape; the period T of the two-dimensional wave shape is 3.0-6.0 mm, preferably 3.0-4.0 mm; the amplitude A of the two-dimensional wave shape is 0.6-1.0 mm, preferably 0.7-0.8 mm; the height H of the two-dimensional wave shape is 4-6 mm, preferably 4.5-5.0 mm.

[0010] Optionally, the shape of the ophthalmic minimally invasive drainage implant device is a three-dimensional spiral shape; the pitch P of the three-dimensional spiral shape is 3.0-8.0 mm, preferably 3.0-5.0 mm; the major diameter D value of the three-dimensional spiral shape is 0.5-1.5 mm, preferably 0.7-1.0 mm; the height H of the three-dimensional spiral shape is 4-6 mm, preferably 4.5-5.0 mm.

[0011] Optionally, the ophthalmic minimally invasive drainage implant device is provided with independent pores or slits communicating the inner cavity with the outer surface;

[0012] The independent pores are bilateral perforations rotating at a predetermined angle along the axial direction of the pipe fitting or unilateral holes rotating at a predetermined angle along the axial direction of the pipe fitting; the processing method of the independent pores can be laser cutting; the shape of the independent pores is a circular hole, a rectangular hole or a special-shaped hole; the slits are intermittent slits or continuous spiral slits uniformly distributed along the axial direction or circumferential direction of the pipe fitting.

[0013] Optionally, the outer surface of the pipe fitting is completely coated with a film layer; the material of the film layer is polytetrafluoroethylene, expanded polytetrafluoroethylene, perfluoroethylenepropylene, polyethylene or silicone rubber.

[0014] The present invention provides a delivery system for delivering the ophthalmic minimally invasive drainage implant device of the present invention. The delivery system includes a puncture needle, a needle seat, a housing, a thimble, a tail seat, a button and a spring;

[0015] The puncture needle is fixedly connected to the needle seat. The puncture needle includes a first cylindrical inner cavity for loading the ophthalmic minimally invasive drainage implant device; the ophthalmic minimally invasive drainage implant device can be elastically compressed and loaded into the first cylindrical inner cavity; the puncture needle is arranged at the front end of the housing, and a part of the puncture needle is inserted into the housing.

[0016] The needle seat is arranged in the housing and can move back and forth relative to the housing; 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 needle seat can be pushed to move back and forth relative to the housing through the button.

[0017] The thimble is fixedly connected to the tail seat. The outer diameter of the thimble is slidably matched with the inner diameter of the puncture needle. The thimble is used to support the ophthalmic minimally invasive drainage implant device, and the tail seat is fixedly connected to the housing.

[0018] Optionally, there are a first state and a second state between the button and the housing; in the first state, the button and the housing form a limit to prevent the needle seat from moving; in the second state, the limiting relationship between the button and the housing is released.

[0019] Optionally, the tail seat includes a blind hole for cooperating and fixing with the thimble and a first locking structure for cooperating and fixing with the housing. The first locking structure is a threaded structure or a snap structure, and the tail seat is fixedly connected to the housing through the first locking structure;

[0020] The puncture needle is made of stainless steel or nickel-titanium shape memory alloy, the needle seat, the outer shell, the tail seat and the button are made of resin, and the thimble and the spring are made of stainless steel.

[0021] Optionally, the outer shell includes a second cylindrical inner cavity that slidably cooperates with the puncture needle, an outer shell inner cavity that slidably cooperates with the outer surface of the needle seat, a first outer shell inner cavity surface and a second outer shell inner cavity surface that slidably cooperate with the outer surface of the button, and a second locking structure that cooperates with the first locking structure.

[0022] Optionally, the needle seat has a third cylindrical inner cavity that is axially the same as the puncture needle and slidably cooperates with the thimble, the needle seat has a rectangular outer surface that slidably cooperates with the outer shell inner cavity, the needle seat has a first needle seat inner cavity surface and a second needle seat inner cavity surface that slidably cooperate with the outer surface of the button, the first needle seat inner cavity surface and the second needle seat inner cavity surface enclose a button installation cavity, and the needle seat has a cylinder that is fixedly cooperated with the inner surface of the spring, and the cylinder is disposed in the button installation cavity.

[0023] Optionally, the button includes a second button outer surface that slidably cooperates with the first needle seat inner cavity surface, a first button outer surface that slidably cooperates with the second needle seat inner cavity surface, a third button outer surface that slidably cooperates with the first outer shell inner cavity surface, a fourth button outer surface that slidably cooperates with the second outer shell inner cavity surface, and a button inner cavity surface that is fixedly cooperated with the spring;

[0024] The width of the first outer shell inner cavity surface is greater than the width of the second outer shell inner cavity surface, and the diameter of the second button outer surface is greater than the width of the second outer shell inner cavity surface, so that the second outer shell inner cavity surface forms a restriction on the second button outer surface in the first state;

[0025] The diameter of the fourth button outer surface is smaller than the diameter of the second button outer surface and is less than or equal to the width of the second outer shell inner cavity surface, so that the fourth button outer surface can slide along the second outer shell inner cavity surface in the second state..

[0026] Optionally, the outer diameter of the puncture needle is 0.5 - 0.7 mm, the inner cavity diameter of the puncture needle is 0.3 - 0.5 mm, and the tip of the puncture needle is a short bevel needle or a round blunt needle;

[0027] The spring includes a spring outer surface that is fixedly cooperated with the button inner cavity surface and a spring inner surface that is fixedly cooperated with the outer surface of the cylinder of the needle seat.

[0028] Additional aspects and advantages of the present invention will be given in part in the following description, will become apparent in part from the following description, or will be understood through the practice of the invention. Description of the Drawings

[0029] The accompanying drawings here are incorporated into the specification and form a part of this specification, showing embodiments in accordance with the present invention, and are used together with the specification to explain the principles of the present invention. In the accompanying drawings, the same components are denoted by the same reference numerals, and the drawings are not drawn to actual scale.

[0030] Figure 1 is a schematic diagram of a two-dimensional wavy drainage implant device in an embodiment of the present invention;

[0031] Figure 2 is a schematic diagram of a two-dimensional wavy drainage implant device with circular pores in an embodiment of the present invention;

[0032] Figure 3 is a schematic diagram of a two-dimensional wavy drainage implant device with continuous spiral slits in an embodiment of the present invention;

[0033] Figure 4 is a schematic diagram of a two-dimensional wavy drainage implant device with a membrane and continuous spiral slits in an embodiment of the present invention;

[0034] Figure 5 is a schematic diagram of a two-dimensional wavy drainage implant device in an embodiment of the present invention (another typical form);

[0035] Figure 6A is a three-dimensional schematic diagram of a three-dimensional spiral drainage implant device in an embodiment of the present invention;

[0036] Figure 6B is a three-view drawing of a three-dimensional spiral drainage implant device in an embodiment of the present invention;

[0037] Figure 7 is a schematic diagram of a puncture needle and a needle holder in an embodiment of the present invention;

[0038] Figure 8 is a schematic diagram of a housing in an embodiment of the present invention;

[0039] Figure 9 is a schematic diagram of a thimble and a tail seat in an embodiment of the present invention;

[0040] Figure 10 is a schematic diagram of a button in an embodiment of the present invention;

[0041] Figure 11 is a schematic diagram of a spring in an embodiment of the present invention;

[0042] Figure 12 is a schematic diagram of the assembly relationship of a delivery system in an embodiment of the present invention;

[0043] Figure 13Schematic diagram of the assembly of the drainage implant device and the delivery system in an embodiment of the present invention;

[0044] Figure 14A Schematic diagram of the cooperation relationship of the components in the initial state of the drainage implant device and the delivery system in an embodiment of the present invention;

[0045] Figure 14B Schematic diagram of the cooperation relationship of the components in the activated state (pressing the button) of the drainage implant device and the delivery system in an embodiment of the present invention;

[0046] Figure 14C Schematic diagram of the cooperation relationship of the components during the release process of the drainage implant device in an embodiment of the present invention;

[0047] Figure 14D Schematic diagram of the cooperation relationship of the components in the completed release state of the drainage implant device in an embodiment of the present invention;

[0048] Figure 15A Schematic diagram of injecting viscoelastic agent into the suprachoroidal space in an embodiment of the present invention;

[0049] Figure 15B Schematic diagram of the position of the puncture needle during the implantation process of the drainage implant device in an embodiment of the present invention;

[0050] Figure 15C Schematic diagram of the completed release of the drainage implant device in an embodiment of the present invention;

[0051] Figure 15D Schematic diagram of the completed implantation of the drainage implant device in an embodiment of the present invention.

[0052] Reference numerals:

[0053] 100 - Two-dimensional wavy drainage implant device; 200 - Three-dimensional spiral drainage implant device; 110, 210 - Inner cavity of the drainage implant device; 121, 221 - Wave crests; 122, 222 - Wave troughs; 131, 132, 133, 134 - Left-handed, 90°-distributed unilateral circular pores; 140 - Gap; 150 - Coating layer;

[0054] 300 - Delivery system;

[0055] 310 - Puncture needle; 311 - First cylindrical inner cavity;

[0056] 320 - Needle holder; 321 - Third cylindrical inner cavity; 322 - Rectangular outer surface; 323 - First inner cavity surface of the needle holder, 324 - Second inner cavity surface of the needle holder; 325 - Cylinder;

[0057] 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;

[0058] 340-thimble;

[0059] 350-tailstock; 351-blind hole; 352-first locking structure;

[0060] 360 - button; 361 - outer surface of the first button; 362 - outer surface of the second button; 363 - outer surface of the third button; 364 - outer surface of the fourth button; 365 - inner surface of the button;

[0061] 370-spring; 371-outer surface of spring; 372-inner surface of spring. DETAILED DESCRIPTION

[0062] The technical solutions of the present invention will be described in further detail below with reference to specific embodiments. It should be understood that the following embodiments are merely illustrative 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 encompassed within the scope of protection that the present invention is intended to protect.

[0063] Based on the problems of poor fixation and difficult processing of current drainage implant devices, and the risks of current external surgical methods, this application provides a new suprachoroidal ophthalmic minimally invasive drainage implant device and its delivery system, which is protected by a suprachoroidal viscoelastic sheath and implanted via an external route.

[0064] This embodiment first provides an ophthalmic minimally invasive drainage implant device, see Figures 1 - 6B The ophthalmic minimally invasive drainage implant device is a tube having an inner cavity (110, 210), and the inner cavity is the passage for aqueous humor to flow from the anterior chamber into the suprachoroidal space. The shape of the ophthalmic minimally invasive drainage implant device is a two-dimensional wave shape or a three-dimensional spiral shape, and has a wave crest (121, 221) and a wave trough (122, 222); the inner cavity is used to connect the anterior chamber of the eye and the suprachoroidal space; the outer diameter of the ophthalmic minimally invasive drainage implant device is 0.3-0.6mm, and the inner diameter of the ophthalmic minimally invasive drainage implant device is 0.05-0.3mm. The above-mentioned drainage implant device is squeezed into the suprachoroidal space and eye tissue, which can enhance the fixing effect of the device in the eye. The drainage implant device preset to a two-dimensional wave shape or a three-dimensional spiral shape can be compressed and loaded into the puncture needle of the delivery system. After being released and implanted into the eye, it can restore the preset shape and then be fixed in the release position.

[0065] In some embodiments, the ophthalmic minimally invasive drainage implant device is made of nickel-titanium shape memory alloy;

[0066] The drainage implant device made of nickel-titanium shape memory alloy material can connect the anterior chamber and the suprachoroidal space, playing the role of a drainage implant device; at the same time, it can meet the requirements of linear compression, and thus can meet the loading and implantation requirements; after being released, it returns to a preset shape, and while playing a drainage role, the preset shape with a specific structure can play a role in preventing slippage and enhancing the fixation effect in the eye.

[0067] Exemplarily, the outer diameter of the minimally invasive ophthalmic drainage implant device is 0.3 - 0.4 mm; the inner diameter of the minimally invasive ophthalmic drainage implant device is 0.10 - 0.20 mm.

[0068] Refer to Figures 1 - 5 , the shape of the minimally invasive ophthalmic drainage implant device is a two-dimensional wavy shape (i.e., the two-dimensional wavy drainage implant device 100); the two-dimensional wavy drainage implant device 100 has wave crests 121 and wave troughs 122, and the main parameters are the inner and outer diameters of the pipe fitting, the wavy period T, the amplitude A, and the height H. The two-dimensional wavy drainage implant device 100 has different typical forms, and specific references can be made to Figure 1 and Figure 5 . Among them, the period T of the two-dimensional wavy shape is 3.0 - 6.0 mm, preferably 3.0 - 4.0 mm; among them, the T value can be set as a gradually changing gradient value; the amplitude A of the two-dimensional wavy shape is 0.6 - 1.0 mm, preferably 0.7 - 0.8 mm, and the A value can be set as a gradually changing gradient value; the height H of the two-dimensional wavy shape is 4 - 6 mm, preferably 4.5 - 5.0 mm.

[0069] Refer to Figure 6, the shape of the minimally invasive ophthalmic drainage implant device is a three-dimensional spiral shape (i.e., the three-dimensional spiral drainage implant device 200); the three-dimensional spiral drainage implant device 200 has wave crests 221 and wave troughs 222, and the main parameters are the inner and outer diameters of the pipe fitting, the spiral pitch P, the major diameter D, and the height H. Among them, the pitch P of the three-dimensional spiral shape is 3.0 - 8.0 mm, preferably 3.0 - 5.0 mm, and the P value can be set as a gradually changing gradient value; the major diameter D value of the three-dimensional spiral shape is 0.5 - 1.5 mm, preferably 0.7 - 1.0 mm, and the D value can be set as a gradually changing gradient value; the height H of the three-dimensional spiral shape is 4 - 6 mm, preferably 4.5 - 5.0 mm.

[0070] In some embodiments, the minimally invasive ophthalmic drainage implant device is provided with independent pores (131, 132, 133, 134) or slits 140 that connect the inner cavity and the outer surface. Specifically, the independent pores are bilateral through-holes rotated at a predetermined angle along the axial direction of the pipe fitting or unilateral holes rotated at a predetermined angle along the axial direction of the pipe fitting; the processing method of the independent pores can be laser cutting; the shape of the independent pores is a circular hole, a rectangular hole, or a special-shaped hole;

[0071] Specifically, the independent pores allow aqueous humor to disperse and flow into the suprachoroidal space, which can enhance the drainage effect. At the same time, the independent pores can reduce the overall stiffness of the drainage implant device and enhance its adaptability to eye tissues. The independent pores can be set as bilateral perforations that rotate at a certain angle (such as 90°) along the axial direction of the pipe fitting, or unilateral holes that rotate at a certain angle (such as 90°) along the axial direction of the pipe fitting. The processing method of the pores can be laser cutting, and the pore shape can be a circular hole, a rectangular hole, or a special-shaped hole, such as Figure 2 in Figure 2 , the circular pores (131, 132, 133, 134) are unilateral holes with left-handed rotation and 90° distribution.

[0072] Furthermore, a gap 140 connecting the inner cavity and the outer surface can be provided at the position where the drainage implant device is implanted into the suprachoroidal space, allowing aqueous humor to disperse and flow into the suprachoroidal space, which can enhance the drainage effect. At the same time, the gap 140 can reduce the overall stiffness of the drainage implant device and enhance its adaptability to eye tissues. The gap 140 can be intermittent gaps evenly distributed along the axial or circumferential direction of the drainage implant device, or continuous spiral-shaped ( Figure 3 ).

[0073] In some embodiments, the outer surface of the pipe fitting is completely coated with a film layer 150; the material of the film layer 150 is polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), perfluoroethylenepropylene (FEP), polyethylene (PE), or silicone rubber. The film layer 150 can cooperate with the independent pores or continuous gaps to improve the structural integrity of the drainage implant device.

[0074] This embodiment further provides a delivery system for delivering the ophthalmic minimally invasive drainage implant device in any of the above embodiments. Refer to Figures 7 - 13 , the delivery system mainly includes a puncture needle 310, a needle seat 320, a housing 330, a push pin 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 the ophthalmic minimally invasive drainage implant device; the ophthalmic minimally invasive drainage implant device can be elastically compressed and loaded into the first cylindrical inner cavity 311 of the puncture needle; the puncture needle 310 is disposed at the front end of the housing 330, and a part of the puncture needle 310 is inserted into the housing 330; the needle seat 320 is disposed in the housing 330 and can move back and forth relative to the housing 330; the button 360 is connected to the needle seat 320 and cooperates with the housing 330; the spring 370 is disposed between the button 360 and the needle seat 320; the needle seat 320 can be pushed to move back and forth relative to the housing 330 by the button 360; the push pin 340 is fixedly connected to the tail seat 350, the outer diameter of the push pin 340 is slidably matched with the inner diameter of the puncture needle 310, and the push pin 340 is used to support the ophthalmic minimally invasive drainage implant device, and the tail seat 350 is fixedly connected to the housing 330.

[0075] The drainage implant device made of nitinol shape memory alloy material can be linearly compressed to meet the implant requirements. One solution is to compress it and load it into a rigid puncture needle 310. Before the drainage implant device is implanted, it is expanded by injecting viscoelastic agent into the suprachoroidal space to facilitate the puncture and positioning of the puncture needle 310. The puncture needle 310, as part of the delivery system, enters the suprachoroidal space and then passes through the anterior chamber angle. After withdrawing the puncture needle, the drainage implant device is released in situ, and then the entire delivery system is withdrawn to complete the implantation process of the drainage implant device.

[0076] In some embodiments, there are a first state and a second state between the button 360 and the housing 330; 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 limiting relationship with the housing 330.

[0077] See Figure 9 , the tail seat 350 includes a blind hole 351 that cooperates with and fixes the thimble 34 (should be 340), a first locking structure 352 that cooperates with and fixes the housing 330. The first locking structure 352 is a threaded structure or a snap structure. The tail seat 350 and the housing 330 are fixedly connected through the first locking structure 352; the puncture needle 310 is made of stainless steel or nitinol shape memory alloy material, and the needle seat 350 (should be 320), the housing 330, the tail seat 350 and the button 360 are made of resin material, and the thimble 340 and the spring 370 are made of stainless steel material.

[0078] See Figure 8 , the housing 330 includes a second cylindrical inner cavity 331 that slidably cooperates with the puncture needle 310, a housing inner cavity 332 that slidably cooperates 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 slidably cooperate with the outer surface of the button 360, and a second locking structure 335 that cooperates with the first locking structure 352. The second locking structure 335 can be a threaded structure or a snap structure, as long as it can be fixedly connected to the first locking structure 352. Among them, the housing inner cavity 332 can be a rectangular inner cavity.

[0079] Among them, the width of the first housing inner cavity surface 333 is greater than the width of the second housing inner cavity surface 334, and the diameter of the second button outer surface 361 is greater than the width of the second housing inner cavity surface 334, so that the second housing inner cavity surface 334 forms a restriction on the second button outer surface 361 in the first state.

[0080] Furthermore, the diameter of the fourth button outer surface 364 is smaller than the diameter of the second button outer surface 362 and is less than or equal to the width of the second housing inner cavity surface 334, so that the fourth button outer surface 364 can slide along the second housing inner cavity surface 334 in the second state.

[0081] See Figure 7, the needle holder 320 has a third cylindrical inner cavity 321 that is axially aligned with the puncture needle 310 and slidably mates with the thimble 340. The needle holder 320 has a rectangular outer surface 322 that slidably mates with the inner cavity of the housing. The needle holder 320 has a first inner surface 323 and a second inner surface 324 of the needle holder that slidably mate with the outer surface of the button 360. The first inner surface 323 and the second inner surface 324 of the needle holder enclose and form a button mounting cavity. The needle holder 320 has a cylinder 325 that fixedly mates with the inner surface of the spring 370. The cylinder 325 is located within the button mounting cavity.

[0082] Refer to Figure 10 , the button 360 includes a second outer surface 361 of the button that slidably mates with the first inner surface 323 of the needle holder, a first outer surface 362 of the button that slidably mates with the second inner surface 324 of the needle holder, a third outer surface 363 of the button that slidably mates with the first inner surface 333 of the housing, a fourth outer surface 364 of the button that slidably mates with the second inner surface 334 of the housing, and an inner surface 365 of the button that fixedly mates with the outer surface of the spring 370. Among them, the diameter of the fourth outer surface 364 of the button is smaller than the diameter of the second outer surface 361 of the button and can slide along the second inner surface 334 of the housing.

[0083] In some embodiments, the outer diameter of the puncture needle 310 is 0.5 - 0.7 mm, the inner cavity diameter of the puncture needle 310 is 0.3 - 0.5 mm, and the tip of the puncture needle 310 is a short bevel needle or a round blunt needle.

[0084] Refer to Figure 11 , the spring 370 has a spring outer surface 371 that fixedly mates with the inner surface 365 of the button and a spring inner surface 372 that fixedly mates with the outer surface of the cylinder 325 of the needle holder 320.

[0085] During the assembly process of the components, after the needle holder 320 is inserted into the inner cavity 332 of the housing, the spring inner surface 372 fixedly mates with the cylinder 325 of the needle holder, the spring outer surface 371 fixedly mates with the inner surface 365 of the button. The second outer surface 362 of the button 360 passes through the first inner surface 333 of the housing 330 by interference fit, realizing the fit between the first inner surface 323 of the needle holder and the second outer surface 362 of the button. At the same time, under the supporting action of the elastic force of the spring 370, the fit between the first inner surface 333 of the housing and the third outer surface 363 of the button is maintained. Since the width of the second inner surface 334 of the housing is smaller than the first inner surface 333 of the housing and cannot adapt to the third outer surface 363 of the button, a limiting connection between the button 360 and the housing 330, and between the button 360 and the needle holder 320 is formed ( Figure 12 , Figure 14A ).

[0086] Refer to Figure 13After the drainage implant device is loaded into the first cylindrical inner cavity 311 of the puncture needle 310, the assembly of the drainage implant device and the delivery system is completed.

[0087] Refer to Figure 14A , the limit connections between the button 360 and the outer shell 330, and between the button 360 and the needle base 320 are in the initial state (i.e., the first state). Refer to Figure 14B , by pressing down the button 360 to release the cooperation between the inner surface 333 of the first outer shell and the outer surface 363 of the third button, the system enters the starting state (i.e., the second state). Refer to Figure 14C , retracting the button 360 realizes the sliding cooperation between the inner surface 334 of the second outer shell and the outer surface 364 of the fourth button. The retracting movement of the button 360 drives the needle base 320 to retract, and similarly realizes the retraction of the puncture needle 310. At the same time, the position of the thimble 340 remains unchanged. Therefore, the thimble 340 pushes the drainage implant device out of the puncture needle 310, thereby realizing the in-situ release of the drainage implant device. Refer to Figure 14D , after removing the force on the button 360, the delivery system can be stabilized in the state where the drainage implant device is released.

[0088] The method of implanting the drainage implant device is a new trans-scleral implanting method based on the protection of the suprachoroidal viscoelastic sheath. The implanting steps are as follows:

[0089] (1) Cut the bulbar conjunctiva at a position 4 mm posterior to the limbus corneae, with a diameter of about 4 mm;

[0090] (2) Refer to Figure 15A , use a syringe or a special instrument (such as a suprachoroidal syringe) to inject viscoelastic agent (about 70 μl / eye) at 4 mm posterior to the limbus corneae;

[0091] (3) Refer to Figure 15B , the puncture needle of the delivery system obliquely punctures into the suprachoroidal space (about a tangent angle of 10 - 15° with the scleral surface) until the end of the puncture needle passes through the anterior chamber angle by about 0.5 mm;

[0092] (4) Refer to Figure 15C , press the button and then retract it to in-situ release the drainage implant device;

[0093] (5) Refer to Figure 15D , pull out the puncture needle to complete the implantation of the drainage implant device;

[0094] (6) Press the puncture site to stop bleeding and make the puncture site self-close (if the puncture site does not self-close, suture the incision with 10-0 suture).

[0095] According to the specific experiment, the following embodiments are continued to be provided in this embodiment.

[0096] The drainage implant device in this embodiment can be released in situ in the eye using the delivery system in this embodiment. In one embodiment, a 23G ultra-thin wall needle tube (outer diameter 0.65 mm, inner diameter 0.46 mm) is selected for the puncture needle in the delivery system, and the needle tip is a blunt needle; in the initial state, the length of the puncture needle extending beyond the outer shell is 8 mm, and in the final state (after the puncture needle is retracted and the drainage implant device is implanted), the length of the puncture needle extending beyond the outer shell is 2 mm, that is, the maximum retraction length of the button is 6 mm; the outer diameter of the thimble in the delivery system is 0.40 mm, and the length of the thimble extending beyond the outer shell is 3 mm; the total length of the delivery system is 100 mm, and the maximum outer diameter is 22 mm.

[0097] Example 1

[0098] Nickel-titanium shape memory alloy pipe fittings with an outer diameter of 0.3 mm and an inner diameter of 0.2 mm are cut into short segments with a length of 5.0 mm, and they are sleeved on a stainless steel wire with an outer diameter of 0.15 mm. The stainless steel wire is pulled to fix the nickel-titanium shape memory alloy pipe fittings in a mold with a three-dimensional spiral groove (there is a metal wire with an outer diameter of 0.2 mm for support in the mold). The width of the groove in the mold is 0.4 mm, and the pitch is 4.5 mm. The mold parameters obtained by machining determine some dimensional parameters of the final drainage implant device. Using the above mold, the spiral pitch P of the drainage implant device can be controlled to be 4.5 mm, the major diameter D to be 0.8 mm, and there is a total of 1 turn.

[0099] The nickel-titanium shape memory alloy pipe is fixed on the mold, heat-treated at 500 °C for 15 min and then water-cooled and quenched to obtain a pipe fitting shaped into a three-dimensional spiral. The pipe fitting is pickled in an acid cleaning solution mainly composed of hydrofluoric acid and nitric acid to remove the oxide scale formed during the heat treatment process, and after cleaning, the three-dimensional spiral drainage implant device is obtained. The drainage implant device has good elasticity and a phase change temperature of 28 °C.

[0100] The drainage implant device is sleeved on a stainless steel wire with an outer diameter of 0.15 mm. The stainless steel wire is inserted into the distal end of the puncture needle of the delivery system. Under the guidance of the stainless steel wire, the drainage implant device is completely compressed and loaded from the distal end of the puncture needle of the delivery system. After the stainless steel wire is withdrawn, the loading of the drainage implant device into the delivery system is completed. The drainage implant device is elastically compressed in the puncture needle and can maintain its relative position with the puncture needle when not under external force.

[0101] The drainage implant device and the delivery system after cleaning and sterilization are implanted into the rabbit eye according to the operation steps. During the operation process, the delivery system functions normally, is easy to operate, and has accurate positioning, and the drainage implant device is successfully implanted into the expected position. The follow-up results for 1 month show that the drainage implant device has normal drainage function, no position movement, and good tissue biocompatibility.

[0102] Example 2

[0103] A continuous spiral slit is machined on a nickel-titanium shape memory alloy pipe fitting with an outer diameter of 0.3 mm and an inner diameter of 0.1 mm by laser cutting, and then cut into short segments with a length of 5.0 mm. The distances between the spiral slit and the ends of the pipe fitting are 1.5 mm and 0.5 mm respectively. The end with a distance of 1.5 mm is the distal end (the end implanted into the anterior chamber). The pitch of the spiral slit is 0.5 mm, with a total of 6 turns, a total length of 3.0 mm, and the width of the slit (on the outer side of the pipe fitting) is 0.06 mm.

[0104] The short pipe fitting with the spiral slit is sleeved on a stainless steel wire with an outer diameter of 0.08 mm, and the stainless steel wire is pulled to fix the pipe fitting in a mold with a three-dimensional spiral groove (there is a metal wire with an outer diameter of 0.2 mm for support in the mold). The width of the groove in the mold is 0.4 mm and the pitch is 3.0 mm. The mold parameters obtained by machining determine some dimensional parameters of the final drainage implant device. Using the above mold, the spiral pitch P of the drainage implant device can be controlled to be 3.0 mm, the major diameter D to be 0.8 mm, and there are a total of 1.5 turns.

[0105] The nickel-titanium shape memory alloy pipe is fixed on the mold, heat-treated at 520 °C for 20 min and then water-cooled and quenched to obtain a pipe fitting shaped into a three-dimensional spiral. The pipe fitting is pickled in a pickling solution mainly composed of hydrofluoric acid and nitric acid to remove the oxide scale formed during the heat treatment process, and then electrochemically polished using an electrochemical workstation in a polishing solution mainly composed of glacial acetic acid, ethanol, ethylene glycol and perchloric acid, and then obtained a three-dimensional spiral drainage implant device with a spiral slit after cleaning. The drainage implant device has good elasticity, a complete shape, and a phase transition temperature of 30 °C.

[0106] The drainage implant device is sleeved on a stainless steel wire with an outer diameter of 0.08 mm. The stainless steel wire is inserted into the distal end of the delivery system puncture needle. Under the guidance of the stainless steel wire, the drainage implant device is completely compressed and loaded from the distal end of the delivery system puncture needle. After the stainless steel wire is withdrawn, the loading of the drainage implant device into the delivery system is completed. The drainage implant device is elastically compressed in the puncture needle and can maintain its relative position with the puncture needle when not under external force.

[0107] After the drainage implant device and the delivery system are cleaned and sterilized, they are implanted into the rabbit eye according to the operation steps. During the operation process, the delivery system functions normally, is easy to operate, and has accurate positioning. The drainage implant device is successfully implanted into the expected position. The follow-up results for 1 month show that the drainage implant device has normal drainage function, no position movement, and good tissue biocompatibility.

[0108] Example 3

[0109] A continuous spiral slit is machined by laser cutting on a nickel-titanium shape memory alloy pipe fitting with an outer diameter of 0.3 mm and an inner diameter of 0.2 mm, and then cut into short segments with a length of 5.0 mm. The distances between the spiral slit and the ends of the pipe fitting are 1.5 mm and 0.5 mm respectively. The end with a distance of 1.5 mm is the distal end (the end implanted into the anterior chamber). The pitch of the spiral slit is 0.5 mm, with a total of 6 turns, a total length of 3.0 mm, and the width of the slit (on the outer side of the pipe fitting) is 0.2 mm.

[0110] The short pipe fittings with spiral slits are loaded into a mold with two-dimensional wavy grooves. The mold parameters obtained by machining determine some dimensional parameters of the final drainage implant device, mainly including the wave period T and the amplitude A. Among them, the value of the period T is a fixed value of 3.0 mm, and the value of the amplitude A is a fixed value of 0.8 mm. Using the above mold, the period T of the drainage implant device can be controlled to be 3.0 mm, the amplitude A to be 0.8 mm, and there are a total of 1.5 periods.

[0111] After the nickel-titanium shape memory alloy pipe is fixed on the mold, it is heat-treated at 500 °C for 15 min and then water-cooled and quenched to obtain a pipe fitting shaped into a two-dimensional wave shape. The pipe fitting is pickled in an acid pickling solution mainly composed of hydrofluoric acid and nitric acid to remove the oxide scale formed during the heat treatment process, and then electrochemically polished using an electrochemical workstation in a polishing solution mainly composed of glacial acetic acid, ethanol, ethylene glycol, and perchloric acid. After cleaning, it is coated with a polytetrafluoroethylene (PTFE) heat-shrinkable tube, and thus a two-dimensional wave-shaped drainage implant device with a spiral slit and a PTFE film layer is obtained. The drainage implant device has good elasticity, a complete shape, a phase transition temperature of 28 °C, and the outer diameter of the pipe fitting after film coating is 0.4 mm. Among them, the PTFE heat-shrinkable tube selects the Sub-Lite-Wall TM ultra-thin heat-shrinkable tube of Zeus Company in the United States, with specific specifications of AWG34 (expanded inner diameter 0.51 mm, restored wall thickness 0.05 mm), and heat-shrunk at 350 °C.

[0112] The drainage implant device is sleeved on a stainless steel wire with an outer diameter of 0.15 mm. The stainless steel wire is inserted into the distal end of the delivery system puncture needle. Under the guidance of the stainless steel wire, the drainage implant device is completely compressed and loaded from the distal end of the delivery system puncture needle. After withdrawing the stainless steel wire, the loading of the drainage implant device into the delivery system is completed. The drainage implant device is elastically compressed in the puncture needle and can maintain its relative position with the puncture needle when not subjected to external forces.

[0113] After the drainage implant device and the delivery system are cleaned and sterilized, they are implanted into the rabbit eye according to the operation steps. During the operation process, the delivery system functions normally, is easy to operate, and has accurate positioning, and the drainage implant device is successfully implanted into the expected position. The follow-up results for 1 month show that the drainage implant device has normal drainage function, no position movement, and good tissue biocompatibility.

[0114] In the description of the present invention, it should be understood that the orientation or positional relationships indicated by the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. are based on the orientation or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation on the present invention.

[0115] In addition, the terms "first" and "second" are only used for descriptive purposes and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, the features defined with "first" and "second" may explicitly or implicitly include at least one of such features. In the description of the present invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise specifically defined.

[0116] In the present invention, unless otherwise clearly specified and limited, the terms "mounted", "connected", "coupled", "fixed", etc. shall be construed in a broad sense. For example, it may be a fixed connection, a detachable connection, or integrated; it may be a mechanical connection, an electrical connection, or communicable with each other; it may be directly connected, or indirectly connected through an intermediate medium, and may be the internal communication of two elements or the interaction relationship between two elements, unless otherwise clearly limited. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0117] In the present invention, unless otherwise clearly specified and limited, the first feature being "on" or "under" the second feature may be that the first and second features are in direct contact, or the first and second features are indirectly in contact through an intermediate medium. Moreover, the first feature being "above", "over" and "on top of" the second feature may be that the first feature is directly above or obliquely above the second feature, or merely indicates that the first feature has a higher horizontal height than the second feature. The first feature being "under", "beneath" and "underneath" the second feature may be that the first feature is directly below or obliquely below the second feature, or merely indicates that the first feature has a lower horizontal height than the second feature.

[0118] In the present invention, terms such as "one embodiment", "some embodiments", "examples", "specific examples", or "some examples" etc. mean that the specific features, structures, materials, or characteristics described in connection with the embodiment or example are included in at least one embodiment or example of the present invention. In this specification, the schematic descriptions of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials, or characteristics described can be combined in a suitable manner in any one or more embodiments or examples. In addition, without contradiction, those skilled in the art can combine and combine the different embodiments or examples described in this specification and the features of different embodiments or examples.

[0119] Although the embodiments of the present invention have been shown and described above, it can be understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those of ordinary skill in the art can make changes, modifications, substitutions, and variations to 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 within the protection scope of the present invention.

Claims

1. An ophthalmic minimally invasive drainage implant device, characterized in that the ophthalmic minimally invasive drainage implant device is a pipe fitting with an inner cavity, the outer diameter of the ophthalmic minimally invasive drainage implant device is 0.3 - 0.6 mm, and the inner diameter of the ophthalmic minimally invasive drainage implant device is 0.05 - 0.3 mm; the shape of the ophthalmic minimally invasive drainage implant device is a two-dimensional wavy shape with wave crests and wave troughs, the period T of the two-dimensional wavy shape is 3.0 - 6.0 mm, the amplitude A of the two-dimensional wavy shape is 0.6 - 1.0 mm, and the height H of the two-dimensional wavy shape is 4 - 6 mm; or, the shape of the ophthalmic minimally invasive drainage implant device is a three-dimensional spiral shape with wave crests and wave troughs, the pitch P of the three-dimensional spiral shape is 3.0 - 8.0 mm, the major diameter D value of the three-dimensional spiral shape is 0.5 - 1.5 mm, and the height H of the three-dimensional spiral shape is 4 - 6 mm; the inner cavity is used to communicate the anterior chamber of the eye with the suprachoroidal space, and the ophthalmic minimally invasive drainage implant device is provided with independent pores communicating the inner cavity with the outer surface, and the independent pores are bilateral perforations rotating at a predetermined angle along the axial direction of the pipe fitting or unilateral holes rotating at a predetermined angle along the axial direction of the pipe fitting; the ophthalmic minimally invasive drainage implant device is made of nickel-titanium shape memory alloy material, and the outer surface of the pipe fitting is completely coated with a film layer.

2. The ophthalmic minimally invasive drainage implant device according to claim 1, characterized in that the outer diameter of the ophthalmic minimally invasive drainage implant device is 0.3 - 0.4 mm; the inner diameter of the ophthalmic minimally invasive drainage implant device is 0.10 - 0.20 mm.

3. The ophthalmic minimally invasive drainage implant device according to claim 1, characterized in that the shape of the ophthalmic minimally invasive drainage implant device is a two-dimensional wavy shape; the period T of the two-dimensional wavy shape is 3.0 - 4.0 mm; the amplitude A of the two-dimensional wavy shape is 0.7 - 0.8 mm; the height H of the two-dimensional wavy shape is 4.5 - 5.0 mm.

4. The ophthalmic minimally invasive drainage implant device according to claim 1, characterized in that the shape of the ophthalmic minimally invasive drainage implant device is a three-dimensional spiral shape; the pitch P of the three-dimensional spiral shape is 3.0 - 5.0 mm; the major diameter D value of the three-dimensional spiral shape is 0.7 - 1.0 mm; the height H of the three-dimensional spiral shape is 4.5 - 5.0 mm.

5. The ophthalmic minimally invasive drainage implant device according to claim 1, characterized in that the processing method of the independent pores can be laser cutting; the shape of the independent pores is a circular hole or a rectangular hole or a special-shaped hole.

6. The ophthalmic minimally invasive drainage implant device according to claim 5, characterized in that the material of the film layer is polytetrafluoroethylene or expanded polytetrafluoroethylene or perfluoroethylenepropylene or polyethylene or silicone rubber.

7. A delivery system for delivering the ophthalmic minimally invasive drainage implant device according to any one of claims 1 - 6, characterized in that the delivery system includes a puncture needle, a needle seat, a housing, a thimble, a tail seat, a button and a spring; The puncture needle is fixedly connected to the needle seat. The puncture needle includes a first cylindrical inner cavity for loading the ophthalmic minimally invasive drainage implant device. The ophthalmic minimally invasive drainage implant device can be elastically compressed and loaded into the first cylindrical inner cavity. The puncture needle is arranged at the front end of the housing, and a part of the puncture needle is inserted into the housing. The needle seat is arranged in the housing and can move back and forth relative to the housing. 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 needle seat can be pushed to move back and forth relative to the housing by the button. The thimble is fixedly connected to the tail seat. The outer diameter of the thimble is in sliding fit with the inner diameter of the puncture needle. The thimble is used to support the ophthalmic minimally invasive drainage implant device. The tail seat is fixedly connected to the housing.

8. The delivery system according to claim 7, wherein There is a first state and a second state between the button and the housing. In the first state, the button and the housing form a limit to prevent the needle seat from moving. In the second state, the limit relationship between the button and the housing is released.

9. The delivery system according to claim 8, wherein The tail seat includes a blind hole that cooperates with and fixes the thimble, and a first locking structure that cooperates with and fixes the housing. The first locking structure is a threaded structure or a snap structure. The tail seat and the housing are fixedly connected through the first locking structure. The puncture needle is made of stainless steel or nickel-titanium shape memory alloy. The needle seat, housing, tail seat and button are made of resin. The thimble and the spring are made of stainless steel.

10. The delivery system according to claim 9, wherein The housing includes a second cylindrical inner cavity that slides with the puncture needle, a housing inner cavity that slides with the outer surface of the needle seat, a first housing inner cavity surface and a second housing inner cavity surface that slide with the outer surface of the button, and a second locking structure that cooperates with the first locking structure.

11. The delivery system according to claim 10, wherein The needle seat has a third cylindrical inner cavity that is axially the same as the puncture needle and slides with the thimble. The needle seat has a rectangular outer surface that slides with the housing inner cavity. The needle seat has a first needle seat inner cavity surface and a second needle seat inner cavity surface that slide with the outer surface of the button. The first needle seat inner cavity surface and the second needle seat inner cavity surface enclose a button installation cavity. The needle seat has a cylinder that is fixedly fitted with the inner surface of the spring. The cylinder is arranged in the button installation cavity.

12. The delivery system according to claim 11, wherein The button includes a second button outer surface that slides with the first needle seat inner cavity surface, a first button outer surface that slides with the second needle seat inner cavity surface, a third button outer surface that slides with the first housing inner cavity surface, a fourth button outer surface that slides with the second housing inner cavity surface, and a button inner cavity surface that is fixedly fitted with the spring. The width of the inner cavity surface of the first housing is greater than the width of the inner cavity surface of the second housing, and the diameter of the outer surface of the second button is greater than the width of the inner cavity surface of the second housing, so that the inner cavity surface of the second housing forms a restriction on the outer surface of the second button in the first state; The diameter of the outer surface of the fourth button is smaller than the diameter of the outer surface of the second button and is less than or equal to the width of the inner cavity surface of the second housing, so that the outer surface of the fourth button can slide along the inner cavity surface of the second housing in the second state.

13. The delivery system according to claim 12, wherein The outer diameter of the puncture needle is 0.5 - 0.7 mm, the inner cavity diameter of the puncture needle is 0.3 - 0.5 mm, and the tip of the puncture needle is a short bevel needle or a round blunt needle; The spring includes a spring outer surface fixedly fitted with the inner cavity surface of the button and a spring inner surface fixedly fitted with the outer surface of the cylinder of the needle seat.

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