Minimally invasive drainage implantation device for ophthalmology department and delivery system of minimally invasive drainage implantation device

Abstract

The invention provides an ophthalmology department minimally invasive drainage implantation device and a delivery system thereof, the ophthalmology department minimally invasive drainage implantation device is a pipe fitting with an inner cavity, the ophthalmology department minimally invasive drainage implantation device is in a two-dimensional wave shape or a three-dimensional spiral shape, and the ophthalmology department minimally invasive drainage implantation device is provided with wave crests and wave troughs; the inner cavity is used for communicating the anterior chamber of the eye with the suprachoroidal space; the external diameter of the minimally invasive drainage implantation device for the ophthalmology department ranges from 0.3 mm to 0.6 mm, and the internal diameter of the minimally invasive drainage implantation device for the ophthalmology department ranges from 0.05 mm to 0.3 mm. The minimally invasive drainage implantation device for the ophthalmology department is prepared from the pipe fitting with the inner cavity, and the loading and implantation requirements can be met; after the drainage tube is released, the drainage tube recovers to be in the preset shape, the drainage effect is achieved, and meanwhile the preset shape of the specific structure can achieve the effects of preventing sliding and enhancing the intraocular fixing effect.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to an ophthalmic minimally invasive drainage implant device 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 drainage implants alone or in combination with cataract removal can effectively, minimally invasively, and conveniently reduce IOP (intraocular pressure). Currently, according to the different anatomical pathways of the implanted device 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 drainage implants for suprachoroidal drainage can be divided into internal and external routes according to the implantation method. Representative implants 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 needs to be performed simultaneously with cataract surgery, and there is a risk of displacement and detachment of the drainage implant after surgery, leading to damage to intraocular tissue. 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 drainage implants are mostly non-metallic tubes with an inner lumen, such as Cypass, which is made of polyimide. Due to the extrusion processing characteristics of the tube, the tube has fixed inner and outer diameter parameters and a fixed axial direction, which makes it easy for the tube to slip in the suprachoroidal space after implantation, affecting the drainage effect. Therefore, in the solution of the tube drainage implant device, a structure that increases the fixing effect of the tube (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 tube (such as the outer diameter of Cypass is 0.40mm and the inner diameter is 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 drainage implant device 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 drainage implant devices.

[0005] The present invention aims to solve one of the technical problems in the related art to at least a certain extent. To this end, the present invention provides an ophthalmic minimally invasive drainage implant device, which is a tube with an inner cavity, and 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 connect the anterior chamber of the eye with the suprachoroidal space; the outer diameter of the ophthalmic minimally invasive drainage implant device is 0.3-0.6mm, and the inner diameter of the ophthalmic minimally invasive drainage implant device is 0.05-0.3mm.

[0006] The ophthalmic minimally invasive drainage implant device of the present invention is prepared by a tube with an inner 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 preset shape with a specific structure can prevent slippage and enhance the fixation effect in the eye.

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

[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 3.0-6.0mm, preferably 3.0-4.0mm; the amplitude A of the two-dimensional wave shape is 0.6-1.0mm, preferably 0.7-0.8mm; the height H of the two-dimensional wave shape is 4-6mm, preferably 4.5-5.0mm.

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

[0011] Optionally, the ophthalmic minimally invasive drainage implant device is provided with an independent hole or gap connecting the inner cavity and the outer surface;

[0012] The independent pores are double-sided through holes rotated at a predetermined angle along the axial direction of the tube or single-sided holes rotated at a predetermined angle along the axial direction of the tube; the independent pores can be processed by laser cutting; the shape of the independent pores is a circular hole, a rectangular hole or an irregular hole; the gaps are intermittent gaps or continuous spiral gaps evenly distributed axially or circumferentially along the tube.

[0013] Optionally, the outer surface of the pipe is completely covered with a coating layer; the coating layer is made of polytetrafluoroethylene or expanded polytetrafluoroethylene or polyperfluoroethylene propylene or 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, wherein the delivery system comprises a puncture needle, a needle seat, a housing, an ejector pin, a tail seat, a button and a spring;

[0015] The puncture needle is fixedly connected to the needle seat, and the puncture needle comprises 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 shell, and a part of the puncture needle is inserted into the interior of the shell;

[0016] The needle seat is arranged in the shell and can move forward and backward relative to the shell; the button is connected to the needle seat and cooperates with the shell; 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 shell;

[0017] The ejector pin is fixedly connected to the tailstock, 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 implantation device, and the tailstock is fixedly connected to the shell.

[0018] 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.

[0019] Optionally, the tailstock comprises a blind hole cooperated and fixed with the ejector pin, and a first locking structure cooperated and fixed with the shell, the first locking structure is a threaded structure or a snap-fit ​​structure, and the tailstock is fixedly connected to the shell through the first locking structure;

[0020] 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.

[0021] 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.

[0022] 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.

[0023] Optionally, 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;

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

[0025] 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 along the inner cavity surface of the second shell in the second state.

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

[0027] 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.

[0028] 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

[0029] 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.

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

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

[0032] Figure 3 is a schematic diagram of a two-dimensional wave-shaped drainage implant device having continuous spiral slits in one embodiment of the present invention;

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

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

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

[0036] Figure 6B 3D spiral drainage implant device according to one embodiment of the present invention;

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

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

[0039] Fig. 9 is a schematic diagram of an ejector pin and a tailstock in one embodiment of the present invention;

[0040] Fig.10 is a schematic diagram of a button in one embodiment of the present invention;

[0041] Fig.11 is a schematic diagram of a spring in one embodiment of the present invention;

[0042] Fig.12 is a schematic diagram of the assembly relationship of the delivery system in one embodiment of the present invention;

[0043] Fig.13is a schematic diagram of the assembly of a drainage implant device and a delivery system in one embodiment of the present invention;

[0044] Fig.14A is a schematic diagram of the coordination relationship between the drainage implant device and the components of the delivery system in the initial state in one embodiment of the present invention;

[0045] Fig. 14B is a schematic diagram of the coordination relationship between the drainage implant device and the delivery system components in the activation state (button pressed) in one embodiment of the present invention;

[0046] Fig. 14C It is a schematic diagram of the coordination relationship of components during the release process of the drainage implant device in one embodiment of the present invention;

[0047] Fig.14D It is a schematic diagram of the matching relationship of the components of the drainage implant device in the release completion state according to one embodiment of the present invention;

[0048] Fig.15A is a schematic diagram of injecting a viscoelastic agent into the suprachoroidal space in one embodiment of the present invention;

[0049] Fig. 15B is a schematic diagram of the position of the puncture needle during the implantation process of the drainage implant device in one embodiment of the present invention;

[0050] Fig. 15C is a schematic diagram of the drainage implant device being released in one embodiment of the present invention;

[0051] Fig.15D It is a schematic diagram of the completion of the implantation of the drainage implant device in one embodiment of the present invention.

[0052] Reference numerals:

[0053] 100-two-dimensional wave-shaped drainage implant device; 200-three-dimensional spiral drainage implant device; 110, 210-inner cavity of drainage implant device; 121, 221-wave crests; 122, 222-wave troughs; 131, 132, 133, 134-left-handed, 90° distributed single-sided circular pores; 140-gap; 150-membrane layer;

[0054] 300-delivery system;

[0055] 310 - puncture needle; 311 - first cylindrical inner cavity;

[0056] 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;

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

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

[0062] 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.

[0063] Based on the problems of poor fixation and difficult processing of current drainage implant devices, and the risks of current external surgical methods, the present 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, referring to Figure 1-6B The ophthalmic minimally invasive drainage implant device is a pipe with 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 with 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 meet the requirements of loading and implantation; after it is released, it returns to a preset shape, and while playing a drainage role, the preset shape with a specific structure can prevent slippage and enhance the fixation effect in the eye.

[0067] For example, 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.

[0068] See also Figure 1-Figure 5 The shape of the ophthalmic minimally invasive drainage implant device is a two-dimensional wave shape (i.e., a two-dimensional wave-shaped drainage implant device 100); the two-dimensional wave-shaped drainage implant device 100 has a wave crest 121 and a wave trough 122, and the main parameters are the inner and outer diameters of the tube, the wave period T, the amplitude A and the height H. The two-dimensional wave-shaped drainage implant device 100 has different typical forms, which can be specifically referred to Figure 1 and Figure 5 . The period T of the two-dimensional wave shape is 3.0-6.0 mm, preferably 3.0-4.0 mm; the T value can be set to a gradual gradient value; the amplitude A of the two-dimensional wave shape is 0.6-1.0 mm, preferably 0.7-0.8 mm, and the A value can be set to a gradual gradient value; the height H of the two-dimensional wave shape is 4-6 mm, preferably 4.5-5.0 mm.

[0069] Referring to FIG. 6 , the shape of the ophthalmic minimally invasive drainage implant device is a three-dimensional spiral (i.e., a three-dimensional spiral drainage implant device 200); the three-dimensional spiral drainage implant device 200 has a crest 221 and a trough 222, and the main parameters are the inner and outer diameters of the tube, the spiral pitch P, the spiral major diameter D, and the height H. Among them, the three-dimensional spiral pitch P is 3.0-8.0 mm, preferably 3.0-5.0 mm, and the P value can be set to a gradual gradient value; the three-dimensional spiral major diameter D value is 0.5-1.5 mm, preferably 0.7-1.0 mm, and the D value can be set to a gradual gradient value; the three-dimensional spiral height H is 4-6 mm, preferably 4.5-5.0 mm.

[0070] In some embodiments, an ophthalmic minimally invasive drainage implant device is provided with independent pores (131, 132, 133, 134) or slits 140 connecting 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 tube or unilateral holes rotated at a predetermined angle along the axial direction of the tube; 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 the eye tissue. The independent pores can be set as bilateral perforations rotated at a certain angle (such as 90°) along the axial direction of the tube, or unilateral holes rotated at a certain angle (such as 90°) along the axial direction of the tube. 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 The middle circular pores (131, 132, 133, 134) are left-handed, 90° distributed single-sided pores.

[0072] Furthermore, the position where the drainage implant device is implanted in the suprachoroidal space may be provided with a gap 140 connecting the inner cavity and the outer surface, so that the aqueous humor can disperse and flow into the suprachoroidal space, thereby enhancing the drainage effect. At the same time, the gap 140 can reduce the overall rigidity of the drainage implant device and enhance its adaptability to the eye tissue. The gap 140 may be an intermittent gap evenly distributed along the axial or circumferential direction of the drainage implant device, or a continuous spiral gap ( Figure 3 ).

[0073] In some embodiments, the outer surface of the tube is completely covered with a coating layer 150; the coating layer 150 is made of polytetrafluoroethylene (PTFE) or expanded polytetrafluoroethylene (ePTFE) or polyperfluoroethylene propylene (FEP) or polyethylene (PE) or silicone rubber. The coating layer 150 can be combined with 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, see Figure 7-Figure 13 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 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 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 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, 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 ophthalmic minimally invasive drainage implant device, and the tail seat 350 is fixedly connected to the shell 330.

[0075] In order to meet the implantation requirements, the drainage implant made of nickel-titanium shape memory alloy material can be linearly compressed. One solution is to compress it and install it into the rigid puncture needle 310. Before the drainage implant 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 and passes through the anterior chamber angle. After the puncture needle is withdrawn, the drainage implant is released in situ, and then the delivery system is withdrawn as a whole to complete the implantation process of the drainage implant.

[0076] 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.

[0077] See also Fig. 9 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.

[0078] See also Figure 8 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.

[0079] 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.

[0080] 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.

[0081] See also Figure 7The 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.

[0082] See also Fig.10 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.

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

[0084] See also Fig.11 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.

[0085] 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.12 , Fig.14A ).

[0086] See also Fig.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] See also Fig.14A , 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. 14B 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 system enters the start-up state (ie, the second state). Fig. 14C The 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 implant device out of the puncture needle 310, thereby realizing the in-situ release of the drainage implant device. Fig.14D After the force on button 360 is removed, the delivery system can be stabilized in a state where the drainage implant device is released.

[0088] The drainage implantation method is a new method of external implantation based on the protection of the suprachoroidal viscoelastic sheath. The implantation steps are as follows:

[0089] (1) Cut the bulbar conjunctiva 4 mm behind the corneoscleral limbus, with a diameter of about 4 mm;

[0090] (2) See Fig.15A , use a syringe or a special instrument (such as a suprachoroidal syringe) to inject viscoelastic (about 70 ml / eye) 4 mm behind the corneoscleral limbus;

[0091] (3) See Fig. 15B The puncture needle of the delivery system is inserted obliquely (at a tangential angle of about 10-15° to the scleral surface) into the suprachoroidal space until the tip of the puncture needle passes through the anterior chamber angle by about 0.5 mm;

[0092] (4) See Fig. 15C , press the button and then withdraw, releasing the drainage implant in situ;

[0093] (5) See Fig.15D , pull out the puncture needle and complete the implantation of the drainage implant device;

[0094] (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).

[0095] The present embodiment continues to provide the following examples according to specific experiments.

[0096] The drainage implant device in this embodiment can use the delivery system in this embodiment for in situ release into the eye. In one embodiment, the puncture needle in the delivery system selects a 23G ultra-thin wall needle tube (outer diameter 0.65mm, inner diameter 0.46mm), and the needle tip is a blunt needle; the length of the puncture needle beyond the shell in the initial state is 8mm, and the length of the puncture needle beyond the shell in the terminal state (puncture needle retracted, drainage implant device implantation is completed) is 2mm, that is, the maximum length of the button retraction is 6mm; the outer diameter of the ejector pin in the delivery system is 0.40mm, and the length of the ejector pin beyond the shell is 3mm; the total length of the delivery system is 100mm, and the maximum outer diameter is 22mm.

[0097] Embodiment 1

[0098] Cut the nickel-titanium shape memory alloy pipe with an outer diameter of 0.3mm and an inner diameter of 0.2mm into short sections with a length of 5.0mm, insert it into a stainless steel wire with an outer diameter of 0.15mm, and pull the stainless steel wire to fix the nickel-titanium shape memory alloy pipe in a mold with a three-dimensional spiral groove (the mold is supported by a metal wire with an outer diameter of 0.2mm). The width of the groove in the mold is 0.4mm and the pitch is 4.5mm. The mold parameters obtained by machining determine some of the 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 4.5mm, the major diameter D to be 0.8mm, and a total of 1 circle.

[0099] The nickel-titanium shape memory alloy tube is fixed on the mold, heat treated at 500°C for 15 minutes and then water-cooled to obtain a three-dimensional spiral tube. The tube 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. After cleaning, a three-dimensional spiral drainage implant is obtained. The drainage implant has good elasticity and a phase transition temperature of 28°C.

[0100] The drainage implant device is inserted into a stainless steel wire with an outer diameter of 0.15 mm, and the stainless steel wire is inserted into the distal end of the puncture needle of the self-delivery system. Under the guidance of the stainless steel wire, the drainage implant device is completely compressed and loaded into the distal end of the puncture needle of the self-delivery system. After the stainless steel wire is withdrawn, the drainage implant device is loaded into the delivery system. The drainage implant device is elastically compressed in the puncture needle, and when no external force is applied, it can maintain its relative position with the puncture needle.

[0101] After cleaning and sterilization, the drainage implant and delivery system were implanted into the rabbit's eye according to the operating procedures. During the operation, the delivery system functioned normally, the operation was convenient, and the positioning was accurate. The drainage implant was successfully implanted in the expected position. The results of the one-month follow-up showed that the drainage implant had normal drainage function, no positional movement, and good tissue biocompatibility.

[0102] Embodiment 2

[0103] Laser cutting was used to process continuous spiral slits on nickel-titanium shape memory alloy tubes with an outer diameter of 0.3mm and an inner diameter of 0.1mm, and then cut into short segments with a length of 5.0mm. The distances between the spiral slit and the ends of the tube were 1.5mm and 0.5mm, respectively, with the end at a distance of 1.5mm being the distal end (the end implanted in the anterior chamber), the spiral slit pitch was 0.5mm, with a total of 6 turns, a total length of 3.0mm, and a slit width (outside the tube) of 0.06mm.

[0104] The short tube with spiral slits is inserted into a stainless steel wire with an outer diameter of 0.08 mm, and the stainless steel wire is pulled to fix the tube in a mold with a three-dimensional spiral groove (the mold is supported by a metal wire with an outer diameter of 0.2 mm), and 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 of the dimensional parameters of the final drainage implant device. The above mold can be used to control the spiral pitch P of the drainage implant device to be 3.0 mm, the major diameter D to be 0.8 mm, and a total of 1.5 turns.

[0105] The nickel-titanium shape memory alloy tube is fixed on the mold, heat treated at 520°C for 20 minutes and then water-cooled to obtain a three-dimensional spiral tube. The tube 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, and then washed to obtain a three-dimensional spiral drainage implant with a spiral gap. The drainage implant has good elasticity, complete morphology, and a phase transition temperature of 30°C.

[0106] The drainage implant device is inserted into a stainless steel wire with an outer diameter of 0.08 mm, and the stainless steel wire is inserted into the distal end of the puncture needle of the self-delivery system. Under the guidance of the stainless steel wire, the drainage implant device is completely compressed and loaded into the distal end of the puncture needle of the self-delivery system. After the stainless steel wire is withdrawn, the drainage implant device is loaded into the delivery system. The drainage implant device is elastically compressed in the puncture needle, and when no external force is applied, it can maintain its relative position with the puncture needle.

[0107] After cleaning and sterilization, the drainage implant and delivery system were implanted into the rabbit's eye according to the operating procedures. During the operation, the delivery system functioned normally, the operation was convenient, and the positioning was accurate. The drainage implant was successfully implanted in the expected position. The results of the one-month follow-up showed that the drainage implant had normal drainage function, no positional movement, and good tissue biocompatibility.

[0108] Embodiment 3

[0109] Laser cutting was used to process continuous spiral slits on nickel-titanium shape memory alloy tubes with an outer diameter of 0.3mm and an inner diameter of 0.2mm, and then cut into short segments with a length of 5.0mm. The distances between the spiral slit and the ends of the tube were 1.5mm and 0.5mm, respectively, with the end at a distance of 1.5mm being the distal end (the end implanted in the anterior chamber), the spiral slit pitch was 0.5mm, with a total of 6 turns, a total length of 3.0mm, and a slit width of 0.2mm (outside the tube).

[0110] The short tube with spiral slits is placed in a mold with two-dimensional wavy grooves. The mold parameters obtained by machining determine some of the dimensional parameters of the final drainage implant, mainly including the wave period T and amplitude A, where the period T value is a fixed value of 3.0 mm and the amplitude A value is a fixed value of 0.8 mm. The above mold can be used to control the drainage implant to have a period T of 3.0 mm, an amplitude A of 0.8 mm, and a total of 1.5 periods.

[0111] After the nickel-titanium shape memory alloy tube is fixed on the mold, it is heat treated at 500°C for 15 minutes and then water-quenched to obtain a two-dimensional wavy pipe fitting. 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, it is coated with a polytetrafluoroethylene (PTFE) heat shrink tube to obtain a two-dimensional wavy drainage implant with a spiral gap and a PTFE coating layer. The drainage implant device has good elasticity, complete morphology, and a phase change temperature of 28°C. The outer diameter of the pipe fitting after coating is 0.4mm. Among them, the PTFE heat shrink tube uses Sub-Lite-Wall from Zeus, USA. TM Ultra-thin heat shrink tubing, with specific specifications of AWG34 (expanded inner diameter 0.51mm, restored wall thickness 0.05mm), heat shrinks at 350°C.

[0112] The drainage implant device is inserted into a stainless steel wire with an outer diameter of 0.15 mm, and the stainless steel wire is inserted into the distal end of the puncture needle of the self-delivery system. Under the guidance of the stainless steel wire, the drainage implant device is completely compressed and loaded into the distal end of the puncture needle of the self-delivery system. After the stainless steel wire is withdrawn, the drainage implant device is loaded into the delivery system. The drainage implant device is elastically compressed in the puncture needle, and when no external force is applied, it can maintain its relative position with the puncture needle.

[0113] After cleaning and sterilization, the drainage implant and delivery system were implanted into the rabbit's eye according to the operating procedures. During the operation, the delivery system functioned normally, the operation was convenient, and the positioning was accurate. The drainage implant was successfully implanted in the expected position. The results of the one-month follow-up showed that the drainage implant had normal drainage function, no positional movement, and good tissue biocompatibility.

[0114] 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 device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as limiting the present invention.

[0115] 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.

[0116] 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.

[0117] 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.

[0118] 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.

[0119] 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 implant device, characterized in that: The ophthalmic minimally invasive drainage implant device is a tube with an inner cavity, and 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 connect 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.

2. The ophthalmic minimally invasive drainage implant device according to claim 1, characterized in that: The ophthalmic minimally invasive drainage implant device is made of nickel-titanium shape memory alloy; 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 wave shape; the period T of the two-dimensional wave shape is 3.0-6.0mm, preferably 3.0-4.0mm; the amplitude A of the two-dimensional wave shape is 0.6-1.0mm, preferably 0.7-0.8mm; the height H of the two-dimensional wave shape is 4-6mm, preferably 4.5-5.0mm.

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; the pitch P of the three-dimensional spiral is 3.0-8.0 mm, preferably 3.0-5.0 mm; the major diameter D value of the three-dimensional spiral is 0.5-1.5 mm, preferably 0.7-1.0 mm; the height H of the three-dimensional spiral is 4-6 mm, preferably 4.5-5.0 mm.

5. The ophthalmic minimally invasive drainage implant device according to claim 1, characterized in that: The ophthalmic minimally invasive drainage implant device is provided with an independent hole or gap connecting the inner cavity and the outer surface; The independent pores are double-sided through holes rotated at a predetermined angle along the axial direction of the tube or single-sided holes rotated at a predetermined angle along the axial direction of the tube; the independent pores can be processed by laser cutting; the shape of the independent pores is a circular hole, a rectangular hole or an irregular hole; the gaps are intermittent gaps or continuous spiral gaps evenly distributed axially or circumferentially along the tube.

6. The ophthalmic minimally invasive drainage implant device according to claim 5, characterized in that: The outer surface of the pipe is completely covered with a coating layer; the coating layer is made of polytetrafluoroethylene or expanded polytetrafluoroethylene or polyperfluoroethylene propylene 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 to 6, 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 puncture needle comprises 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 shell, and a part of the puncture needle is inserted into the interior of the shell; The needle seat is arranged in the shell and can move forward and backward relative to the shell; the button is connected to the needle seat and cooperates with the shell; 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 shell; The ejector pin is fixedly connected to the tailstock, 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 implantation device, and the tailstock is fixedly connected to the shell.

8. The delivery system according to claim 7, 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.

9. The delivery system according to claim 7, characterized in that The tailstock comprises a blind hole that cooperates with the ejector pin and a first locking structure that cooperates with the shell, the first locking structure is a threaded structure or a buckle structure, and the tailstock is fixedly connected to the shell 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.

10. The delivery system according to claim 9, 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.

11. The delivery system according to claim 10, 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. 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.

12. The delivery system according to claim 11, 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 first shell inner cavity surface is greater than the width of the second shell inner cavity surface, and the diameter of the second button outer surface is greater than the width of the second shell inner cavity surface, so that the second shell inner cavity surface forms a restriction on the second button outer surface 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 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 along the inner cavity surface of the second shell in the second state.

13. The delivery system according to claim 12, characterized in that The outer diameter of the puncture needle is 0.5-0.7 mm, the inner diameter of the puncture needle is 0.3-0.5 mm, and the needle tip of the puncture needle is a short bevel needle or a round 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.

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