CN119700417B - Ophthalmic minimally invasive drainage device with expansion fixing function and delivery system thereof - Google Patents
Ophthalmic minimally invasive drainage device with expansion fixing function and delivery system thereofInfo
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- CN119700417B CN119700417B CN202411811188.8A CN202411811188A CN119700417B CN 119700417 B CN119700417 B CN 119700417B CN 202411811188 A CN202411811188 A CN 202411811188A CN 119700417 B CN119700417 B CN 119700417B
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Abstract
本发明提供一种具有扩张固定功能的眼科微创引流器及其递送系统，该眼科微创引流器包括具有中空腔体的引流主体和扩张固定器，引流主体包括近端部和远离近端部的远端部；扩张固定器的形状为二维平面形或三维立体形，并且具有第一端和第二端，第一端与引流主体的近端部相连接，第二端与引流主体的远端部相连接；近端部为靠近脉络膜上腔的一端，其长度为0.2‑2.5mm，远端部为靠近眼前房的一端，其长度为0.5‑3.0mm。本发明的具有扩张固定功能的眼科微创引流器采用具有中空腔体的引流主体，能够满足装载及植入要求；待其释放后恢复成预设的形状，在起到引流作用的同时，扩张固定器可以起到增强在眼内固定效果、形成睫状体解离进而促进房水吸收和抑制房水分泌的作用。
The present invention provides an ophthalmic minimally invasive drainage device with an expansion and fixation function and a delivery system thereof, wherein the ophthalmic minimally invasive drainage device comprises a drainage body with a hollow cavity and an expansion fixator, wherein the drainage body comprises a proximal portion and a distal portion away from the proximal portion; the expansion fixator is in a two-dimensional plane or a three-dimensional solid shape and has a first end and a second end, the first end being connected to the proximal portion of the drainage body, and the second end being connected to the distal portion of the drainage body; the proximal portion is an end close to the suprachoroidal space, and its length is 0.2-2.5 mm, and the distal portion is an end close to the anterior chamber of the eye, and its length is 0.5-3.0 mm. The ophthalmic minimally invasive drainage device with an expansion and fixation function of the present invention adopts a drainage body with a hollow cavity, which can meet the requirements of loading and implantation; after being released, it returns to a preset shape. While playing a drainage role, the expansion fixator can enhance the fixation effect in the eye, form ciliary body dissociation, and thereby promote aqueous humor absorption and inhibit aqueous humor secretion.
Description
Technical Field
The invention relates to the field of medical instruments, in particular to an ophthalmic minimally invasive drainage device with an expansion fixing function and a delivery system thereof.
Background
MIGS (minimally invasive glaucoma surgery) is an emerging surgical technique for treating light and moderate glaucoma, and implantation of a drainage device after cataract extraction alone or in combination can effectively, minimally invasively and conveniently lower IOP (intraocular pressure). According to the different anatomical approaches of drainage device drainage of aqueous humor, MIGS can be divided into subconjunctival drainage, schlemm's tube drainage and vein collateral membrane upper cavity drainage. Among them, suprachoroidal drainage is an ideal route because the suprachoroidal space is the physiological drainage route of aqueous humor, is large in space, and operates without forming a bleb. Currently, MIGS drainage devices that drain through the superior lumen of the vein are classified into an internal and an external channel according to the implantation method. Typical drainage devices for the internal route include Cypass, iStentSupra, miniJect, and typical implantation devices for the external route include Slox Gold shunt and Aquashunt, STARflo. The mode can effectively reduce the IOP of glaucoma patients, but the operation of the cataract operation is combined through an internal route method, and the risk of displacement and falling off of the drainage device exists after the operation, so that the intraocular tissue is damaged. The external way method operation has large wound, severe complications such as explosive suprachoroidal hemorrhage and the like can occur in the period of the perioperative operation, and the fibrosis of the internal drainage area is obvious. These factors limit the clinical application of the superior luminal drainage of MIGS through the vein.
The suprachoroidal drainage device is mostly a nonmetallic tube with a tube cavity, for example Cypass is made of polyimide. Because of the extrusion processing characteristic of the pipe fitting, the pipe fitting has fixed inner and outer diameter parameters and fixed axial direction, so that the pipe fitting is easy to slide in the suprachoroidal space after implantation, and the drainage effect is affected. Therefore, in the tube drainer solution, a structure (such as a ring with an increased outer diameter provided in Cypass) for increasing the fixing effect of the tube is provided, but the fixing structure is difficult to process due to the limitation of the smaller overall size of the tube (such as Cypass with an outer diameter of about 0.40mm and an inner diameter of about 0.30 mm).
Disclosure of Invention
The inventor researches and discovers that the nickel-titanium shape memory alloy (the mass fraction of nickel is 54.5% -57.0%) is a shape memory alloy, and the nickel-titanium shape memory alloy material has good biocompatibility and excellent shape memory property and is widely applied to intravascular implantation devices such as intravascular stents, filters and the like at present, but has less application as an MIGS drainage device. Hydrus Microstent of nickel-titanium shape memory alloy material is a product of Schlemm's tube drainage mode. Hydrus Microstent shows that the nickel-titanium shape memory alloy material can be successfully applied to the ophthalmic drainage device.
The present invention aims to solve at least one of the technical problems in the related art to some extent. Therefore, the invention provides an ophthalmic minimally invasive drainage device with an expansion fixing function, which comprises a drainage main body with a hollow cavity and an expansion fixing device connected with the drainage main body, wherein:
The expansion fixer is in a two-dimensional plane shape or a three-dimensional shape, and is provided with a first end and a second end, wherein the first end is connected with the proximal end of the drainage main body, and the second end is connected with the distal end of the drainage main body;
The proximal end of the drainage body is one end close to the suprachoroidal space and has a length of 0.2-2.5mm, and the distal end of the drainage body is one end close to the anterior chamber of the eye and has a length of 0.5-3.0mm.
The ophthalmic minimally invasive drainage device with the expansion fixing function is prepared from the drainage main body with the hollow cavity, can meet loading and implantation requirements, and can recover to a preset shape after being released, and the expansion fixing device can play a role in preventing slipping and enhancing the fixing effect in eyes and realize the expansion fixing function of the ophthalmic minimally invasive drainage device while playing a role in drainage. In addition, the expansion fixer spread in the upper ciliary cavity can realize the dissociation of ciliary body to some extent, so that the aqueous humor drained from the anterior chamber enters the supraciliary cavity of the ciliary body and is absorbed through the sclera or the choroidal blood vessel, and meanwhile, the dissociation of ciliary body caused by the expansion fixer can inhibit the secretion of aqueous humor by the pigment-free epithelial cells of the ciliary body, so that the intraocular pressure is further reduced.
Optionally, the ophthalmic minimally invasive drainage device with the expansion fixing function is made of nickel-titanium shape memory alloy materials;
the drainage main body and the expansion fixer are integrally formed or split-type combined;
the external diameter of the drainage main body is 0.15-0.6mm, and the internal diameter of the drainage main body is 0.05-0.4mm.
The expansion fixer comprises 2 expansion ribs which are symmetrically arranged relative to the axial direction of the drainage body, for example, the expansion fixer is provided with 2 expansion ribs which are distributed at 180 degrees and are parallel to the axial direction of the drainage body, and the two-dimensional expansion plane formed by the 2 expansion ribs has a first expansion diameter which is 0.6-2.0mm, preferably 0.8-1.5mm. The expansion fixer can be integrated with the drainage main body or formed into an assembly with the drainage main body, and the assembly mode comprises welding or biocompatible glue bonding.
Optionally, the drainage body may be a drainage tube with an inner cavity, the first end and the second end of the expansion fixer are respectively sleeved on the outer wall of the drainage tube, any one of the first end and the second end is fixedly connected with the outer wall of the drainage tube, and the other end is a free sliding end.
Optionally, the expansion anchor has a three-dimensional shape, and comprises n expansion ribs, wherein n is an integer greater than 2, preferably n is 3 or 4;
The n expansion ribs are arranged at uniform intervals along the circumferential direction of the drainage body, for example, the expansion ribs are n expansion ribs uniformly distributed at 360 degrees/n angles and are arranged along the axial direction parallel to the drainage body, or the expansion ribs are spirally arranged along the axial direction of the drainage body.
Optionally, the expansion fixer includes 3 expansion ribs uniformly arranged along the circumferential direction of the drainage main body, the three-dimensional expansion structure formed by the 3 expansion ribs has a second expansion diameter, the second expansion diameter is 0.4-1.2mm, preferably, the second expansion diameter is 0.6-0.8mm, the expansion fixer can be integrated with the drainage main body or formed into an assembly with the drainage main body, and the assembly mode includes welding or biocompatible glue bonding.
Optionally wherein the two-dimensional planar shaped expansion anchor has a length of 0.9-2.2mm, preferably 1.0-1.8mm, or the three-dimensional shaped expansion anchor has a length of 0.8-1.8mm, preferably 1.0-1.5mm, preferably the two-dimensional planar shaped expansion anchor or the three-dimensional shaped expansion anchor is configured to be ciliary body dissociated to allow aqueous humor drained from the anterior chamber to enter the suprachoroidal space and be absorbed through the sclera or the choroidal blood vessel.
The invention provides a delivery system for delivering the ophthalmic minimally invasive drainage device with the expansion fixing function, which comprises a puncture needle, a needle seat, a shell, a thimble, a tailstock, a button and a spring;
The puncture needle is fixedly connected with the needle seat, the needle seat is arranged in the shell and can move back and forth relative to the shell, the puncture needle comprises a first cylindrical inner cavity for loading the ophthalmic minimally invasive drainage device with the expansion fixing function, the ophthalmic minimally invasive drainage device can be elastically compressed and installed in the first cylindrical inner cavity, the puncture needle is arranged at the front end of the shell, and at least one part of the puncture needle is inserted into the shell;
The spring is arranged between the button and the needle seat, and can push the needle seat to move back and forth relative to the shell through the button;
The ejector pin with tailstock fixed connection, the ejector pin external diameter with pjncture needle internal diameter sliding fit, the ejector pin is used for supporting ophthalmic minimally invasive drainage ware with expansion fixed function, the tailstock with shell fixed connection.
Optionally, a first state and a second state are arranged between the button and the shell, the button and the shell form limit in the first state so as to avoid the movement of the needle seat, and the button is released from limit relation with the shell in the second state.
Optionally, the tailstock comprises a blind hole matched and fixed with the thimble and a first locking structure matched and fixed with the shell, the first locking structure is a threaded structure or a buckle structure, and the tailstock is fixedly connected with the shell through the first locking structure;
the puncture needle is made of stainless steel or nickel-titanium shape memory alloy, the needle seat, the shell, the tailstock and the button are made of resin, and the thimble and the spring are made of stainless steel.
Optionally, the housing includes a second cylindrical inner cavity slidably engaged with the needle, a housing inner cavity slidably engaged with the hub outer surface, first and second housing inner cavity surfaces slidably engaged with the button outer surface, and a second locking structure engaged with the first locking structure.
Optionally, the needle seat has the same with the pjncture needle axial, with thimble sliding fit's third cylindrical inner chamber, the needle seat have with shell inner chamber sliding fit's rectangle surface, the needle seat have with button surface sliding fit's first needle seat inner chamber face and second needle seat inner chamber face, first needle seat inner chamber face and second needle seat inner chamber face enclose to establish and form the button installation cavity, the needle seat have with spring internal surface fixed fit's cylinder, the cylinder set up in the button installation cavity.
Optionally, the button comprises a second button outer surface in sliding fit with the first needle seat inner cavity surface, a first button outer surface in sliding fit with the second needle seat inner cavity surface, a third button outer surface in sliding fit with the first housing inner cavity surface, a fourth button outer surface in sliding fit with the second housing inner cavity surface, and a button inner cavity surface in fixed fit with the spring;
The width of the inner cavity surface of the first shell is larger than that of the inner cavity surface of the second shell, and the diameter of the outer surface of the second button is larger than that of the inner cavity surface of the second shell, so that the outer surface of the second button facing the inner cavity surface of the second shell forms a locking limit in the first state;
The diameter of the fourth button outer surface is smaller than the diameter of the second button outer surface and is smaller than or equal to the width of the second housing inner cavity surface, so that the fourth button outer surface can relatively slide along the second housing inner cavity surface in the second state.
Optionally, the outer diameter of the puncture needle is 0.4-0.8mm, the inner cavity diameter of the puncture needle is 0.18-0.61mm, and the puncture needle is a round blunt needle;
the spring comprises a spring outer surface fixedly matched with the inner cavity surface of the button and a spring inner surface fixedly matched with the outer surface of the cylinder of the needle seat.
Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention.
Drawings
The accompanying drawings, where like reference numerals refer to like parts throughout and which are not to actual scale, illustrate embodiments consistent with the present invention and together with the description serve to explain the principles of the invention.
FIG. 1A is a schematic view of a drainage device with a two-dimensional planar expansion anchor according to an embodiment of the present invention;
FIG. 1B is a schematic view of a drainage device with a two-dimensional planar expansion anchor according to another embodiment of the present invention;
FIG. 2 is a schematic view of a drainage device with a three-dimensional expansion anchor according to yet another embodiment of the present invention;
FIG. 3 is a schematic view of a drainage device with a three-dimensional expansion anchor according to yet another embodiment of the present invention;
FIG. 4 is a schematic view of the structure of the puncture needle and the needle holder of the delivery system according to an embodiment of the present invention;
FIG. 5 is a schematic structural view of the housing of the delivery system in one embodiment of the invention;
FIG. 6 is a schematic view of the structure of the ejector pins and tailstock of the delivery system according to an embodiment of the present invention;
FIG. 7 is a schematic diagram of the structure of a button of a delivery system in an embodiment of the present invention;
FIG. 8 is a schematic view of the structure of a spring of the delivery system in one embodiment of the invention;
FIG. 9 is a schematic illustration of the assembly relationship of a delivery system in an embodiment of the present invention;
FIG. 10 is a schematic illustration of an assembly of a flow diverter with a delivery system according to one embodiment of the present invention;
FIG. 11A is a schematic diagram illustrating the mating relationship of the flow diverter and the initial state components of the delivery system in accordance with one embodiment of the present invention;
FIG. 11B is a schematic illustration of the mating relationship of the flow diverter and the delivery system activation state (button pressed) component in accordance with one embodiment of the present invention;
FIG. 11C is a schematic diagram showing the mating relationship of components during the release of the flow diverter according to one embodiment of the present invention;
FIG. 11D is a schematic diagram showing the assembly engagement relationship of the drainage device in a released and completed state according to an embodiment of the present invention;
FIG. 12A is a schematic representation of suprachoroidal space injection of a viscoelastic in an embodiment of the present invention;
FIG. 12B is a schematic view of the placement of the drainage device according to an embodiment of the present invention;
FIG. 12C is a schematic illustration of the completion of the release of the flow diverter according to one embodiment of the present invention;
FIG. 12D is a schematic illustration of the completion of the implantation of the drainage device according to an embodiment of the present invention;
FIG. 13 is an AS-OCT image of a drain-to-rabbit eye implanted for 1 month in an embodiment of the present invention.
Reference numerals:
100-drainage device with two-dimensional plane expansion fixer;
200-a drainage device with a three-dimensional expansion fixer;
110. 210-distal end of drainage body, 130, 230-proximal end of drainage body, 140, 240-hollow lumen of drainage body, 121, 122-first expansion tendon of two-dimensional plane shape;
the second expansion anchor is 150-two-dimensional plane-shaped, 151, 152-two-dimensional plane-shaped second expansion ribs;
221. 222, 223-third expansion ribs in three-dimensional form;
224. 225, 226-a fourth expanding rib in the form of a three-dimensional solid;
300-a delivery system;
310-puncture needle 311-first cylindrical inner cavity;
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;
330-housing, 331-second cylindrical cavity, 332-housing cavity, 333-first housing cavity face, 334-second housing cavity face, 335-second locking structure;
340-thimble;
350-tailstock, 351-blind hole, 352-first locking structure;
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;
370-spring, 371-spring outer surface, 372-spring inner surface.
Detailed Description
The technical scheme of the invention will be further described in detail below with reference to specific embodiments. It is to be understood that the following examples are illustrative only and are not to be construed as limiting the scope of the invention. All techniques implemented based on the above description of the invention are intended to be included within the scope of the invention.
The invention provides a brand-new ophthalmic minimally invasive drainage device with an expansion fixation function based on suprachoroidal space and a delivery system thereof, wherein the ophthalmic minimally invasive drainage device is protected by a suprachoroidal space viscoelastic sheath and is implanted via an external way based on the problems of poor fixation effect and difficult processing of the current drainage device and the problem of the risk of the current external way operation.
The present embodiment first provides an ophthalmic minimally invasive drainage device with an expansion fixation function, referring to fig. 1-3, the ophthalmic minimally invasive drainage device is a drainage body with a hollow cavity (140, 240), the hollow cavity (140, 240) is a passage for aqueous humor to flow into suprachoroidal space from anterior chamber, the drainage body comprises a proximal end (130, 230) and a distal end (110, 210) far away from the proximal end, wherein one end of the drainage body entering anterior chamber of an eye is the distal end (110, 210) and one end of the drainage body at the suprachoroidal space is the proximal end (130, 230), the ophthalmic minimally invasive drainage device with an expansion fixation function is further provided with an expansion fixation device capable of enhancing the fixation effect in the eye and having a ciliary body dissociation function, the expansion fixation device can be integrated with the drainage body or combined with the drainage body (150), and the combination mode comprises welding or biocompatible glue.
The expansion anchor is shaped as a two-dimensional plane or a three-dimensional solid, the two-dimensional plane expansion anchor having a first end connected to the proximal end (130, 230) of the drainage body and a second end connected to the distal end (110, 210) of the drainage body. The expansion anchor comprises 2 expansion ribs (121, 122, 151, 152) which are symmetrically distributed with the drainage body and are parallel to the axial direction of the drainage body, such as first expansion ribs (121, 122) or second expansion ribs (151, 152), the expansion anchor can further comprise n expansion ribs (221, 222, 223, 224, 225, 226) which are uniformly distributed along the circumferential direction of the drainage body at intervals, and in particular, the expansion anchor can be provided with n expansion ribs which are uniformly distributed along the circumferential direction of the drainage body at an angle of 360 DEG/n, wherein n is an integer, preferably, n is 3 or 4. The expansion fixator can comprise third expansion ribs (221, 222, 223) which are uniformly arranged along the axial direction parallel to the drainage main body, and can also comprise fourth expansion ribs (224, 225, 226) which are spirally distributed along the axial direction of the drainage main body. The drainage device is extruded in the suprachoroidal space and the eye tissue, so that the fixation effect of the implantation device in the eye can be enhanced. The drainage device with the preset two-dimensional plane-shaped or three-dimensional-shaped expansion fixer can be compressed and put into a puncture needle of a delivery system, and can restore the preset shape after being released and implanted into the eye, and then is fixed at the release position.
In some embodiments, the ophthalmic minimally invasive drainage device is made of nickel-titanium shape memory alloy materials, and the drainage body and the expansion fixator are integrally formed or split-type combined.
The drainage device processed by the nickel-titanium shape memory alloy material can be communicated with the anterior chamber and the suprachoroidal space to play a role of the drainage device, can meet the requirement of linear compression and further meet the loading and implantation requirements, and can recover to a preset shape after being released, so that the drainage device has a drainage effect, and meanwhile, the preset shape with a specific structure can play a role of preventing slippage and enhancing the fixation effect in eyes. In addition, the expansion fixer spread in the upper ciliary cavity can realize the dissociation of ciliary body to some extent, so that the aqueous humor drained from the anterior chamber enters the supraciliary cavity of the ciliary body and is absorbed through the sclera or the choroidal blood vessel, and meanwhile, the dissociation of ciliary body caused by the expansion fixer can inhibit the secretion of aqueous humor by the pigment-free epithelial cells of the ciliary body, so that the intraocular pressure is further reduced.
Preferably, the external diameter of the drainage main body of the ophthalmic minimally invasive drainage device is 0.15-0.6mm, the internal diameter of the drainage main body is 0.05-0.4mm, the total length of the ophthalmic minimally invasive drainage device is 2.5-7.0mm, the length of the distal end part of the drainage main body of the ophthalmic minimally invasive drainage device entering one end of an anterior chamber of an eye is 0.5-3.0mm, and the length of the proximal end part of the drainage main body of the ophthalmic minimally invasive drainage device at one end of a suprachoroidal space is 0.2-2.5mm.
Referring to fig. 1A and 1B, the drainage device (100) with a two-dimensional planar expansion anchor is composed of 2 expansion ribs (121, 122, 151, 152) symmetrically arranged about the axis of the drainage body, and the expansion anchor may be integrated with the drainage body (fig. 1A) or may be combined with the drainage body (fig. 1B). The 2 expansion ribs may constitute a predetermined two-dimensional expansion plane having a first expansion diameter of 0.6-2.0mm, preferably 0.8-1.5mm. The first expansion diameter and the second expansion diameter described below refer to the diameters of the circumscribing circles formed by the expanded ribs in the direction perpendicular to the axial direction of the drainage body after the expanded ribs are expanded.
In the case of a split assembly (see FIG. 1B), the drainage body and the expansion anchor are separate components from each other and may be assembled to form an assembly (150). For example, the drainage body may be a drainage tube having an inner cavity, the first end and the second end of the expansion anchor are respectively sleeved on the outer wall of the drainage tube, any one of the first end and the second end is fixedly connected with the outer wall of the drainage tube, for example, a laser welding machine is used for performing spot welding connection with the drainage tube at any one end of the expansion anchor, and the other end is a free sliding end and can slide on the drainage tube.
Referring to fig. 2 and 3, the drainage device (200) with the three-dimensional solid expansion anchor is composed of 3 expansion ribs uniformly arranged along the circumferential direction of the drainage body, for example, 3 third expansion ribs (221, 222, 223) or fourth expansion ribs (224, 225, 226) uniformly distributed at 120-degree angular intervals, wherein the third expansion ribs (221, 222, 223) can be axially distributed parallel to the drainage body (fig. 2), and the fourth expansion ribs (224, 225, 226) can also be axially spirally distributed relative to the drainage body (fig. 3). The expansion fixer can be integrated with the drainage main body or combined with the drainage main body. The three-dimensional expanded structure of 3 expanded beads of this embodiment has a second expanded diameter, which may be 0.4-1.2mm, preferably 0.6-0.8mm.
According to one embodiment, the two-dimensional planar expansion anchor has a length of 0.9-2.2mm, preferably 1.0-1.8mm, or the three-dimensional solid expansion anchor has a length of 0.8-1.8mm, preferably 1.0-1.5mm.
This embodiment further provides a delivery system for delivering the ophthalmic minimally invasive drainage device according to any of the above embodiments, referring to fig. 4-10, the delivery system mainly comprises a puncture needle 310, a needle holder 320, a housing 330, a thimble 340, a tailstock 350, a button 360 and a spring 370, wherein the puncture needle 310 is fixedly connected with the needle holder 320, the puncture needle 310 comprises a first cylindrical cavity 311 for loading the ophthalmic minimally invasive drainage device, the ophthalmic minimally invasive drainage device can be elastically compressed and installed in the first cylindrical cavity 311 of the puncture needle, the puncture needle 310 is arranged at the front end of the housing 330, a part of the puncture needle 310 is inserted into the housing 330, the needle holder 320 is arranged in the housing 330 and can move back and forth relative to the housing 330, the button 360 is connected with the needle holder 320 and is matched with the housing 330, the spring 370 is arranged between the button 360 and the needle holder 320, the button 360 can push the needle holder 320 to move back and forth relative to the housing 330, the thimble 340 is fixedly connected with the tailstock 350, the outside diameter of the thimble 340 is matched with the inside diameter of the puncture needle 310 in a sliding manner, and the thimble 340 is used for supporting the minimally invasive drainage device, and the tailstock is fixedly connected with the housing 330.
In order to meet the implantation requirement, the drainage device made of the nickel-titanium shape memory alloy material can be linearly compressed, and one scheme is that the expansion fixer is completely compressed and installed in the rigid puncture needle 310, and the length of the distal end part of the drainage main body exposed out of the puncture needle 310 is 0.5-3.0mm. Prior to implantation, the drainage device is distracted by injecting a viscoelastic into the suprachoroidal space for penetration and positioning of the needle 310. The needle 310 is used as part of a delivery system that enters the suprachoroidal space until the distal end of the body of the flow diverter passes through the anterior chamber angle 0.3-1.0mm, the flow diverter is released in situ after retraction of the needle, and then the delivery system is withdrawn entirely to complete the implantation procedure of the flow diverter.
In some embodiments, the button 360 has a first state and a second state between the button and the housing 330, the button 360 forms a stop with the housing 330 in the first state to prevent movement of the hub 320, and the button 360 releases the stop relationship with the housing 330 in the second state.
Referring to fig. 6, the tail seat 350 includes a blind hole 351 fixed in cooperation with the ejector pin 340, and a first locking structure 352 fixed in cooperation with the housing 330, wherein the first locking structure 352 is a threaded structure or a snap-in structure, the tail seat 350 is fixedly connected with the housing 330 through the first locking structure 352, the puncture needle 310 is made of stainless steel or nickel-titanium shape memory alloy, the needle seat 350, the housing 330, the tail seat 350 and the button 360 are made of resin, and the ejector pin 340 and the spring 370 are made of stainless steel.
Referring to fig. 5, the housing 330 includes a second cylindrical inner cavity 331 slidably engaged with the lancet 310, a housing inner cavity 332 slidably engaged with the outer surface of the needle holder 320, a first housing inner cavity surface 333 and a second housing inner cavity surface 334 slidably engaged with the outer surface of the button 360, and a second locking structure 335 engaged with the first locking structure 352, wherein the second locking structure 335 may be a threaded structure or a snap-fit structure as long as it is fixedly connected with the first locking structure 352. Wherein the housing lumen 332 may be a rectangular lumen.
Wherein the width of the first housing interior cavity surface 333 is greater than the width of the second housing interior cavity surface 334 and the diameter of the second button exterior surface 361 is greater than the width of the second housing interior cavity surface 334 such that the second housing interior cavity surface 334 defines a restriction to the second button exterior surface 361 in the first state.
Further, 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 housing inner cavity surface 334 such that the fourth button outer surface 364 is capable of sliding along the second housing inner cavity surface 334 in the second state.
Referring to fig. 4, the needle holder 320 has a third cylindrical inner cavity 321 axially identical to the puncture needle 310 and slidably engaged with the needle 340, the needle holder 320 has a rectangular outer surface 322 slidably engaged with the housing inner cavity, the needle holder 320 has a first needle holder inner cavity surface 323 slidably engaged with the outer surface of the button 360 and a second needle holder inner cavity surface 324, the first needle holder inner cavity surface 323 and the second needle holder inner cavity surface 324 enclose to form a button mounting cavity, the needle holder 320 has a cylinder 325 fixedly engaged with the inner surface of the spring 370, and the cylinder 325 is located in the button mounting cavity.
Referring to fig. 7, button 360 includes a second button outer surface 361 that is in sliding engagement with first hub inner cavity surface 323, a first button outer surface 362 that is in sliding engagement with second hub inner cavity surface 324, a third button outer surface 363 that is in sliding engagement with first housing inner cavity surface 333, a fourth button outer surface 364 that is in sliding engagement with second housing inner cavity surface 334, and a button inner cavity surface 365 that is in fixed engagement with an outer surface of spring 370. Wherein the fourth button outer surface 364 has a smaller diameter than the second button outer surface 361 and is slidable along the second housing inner cavity surface 334.
In some embodiments, the outer diameter of the lancet 310 is 0.4-0.8mm, the lumen diameter of the lancet 310 is 0.18-0.61mm, and the tip of the lancet 310 is a blunt needle.
Referring to fig. 8, spring 370 has a spring outer surface 371 that fixedly mates with button inner cavity surface 365 and a spring inner surface 372 that fixedly mates with the outer surface of cylinder 325 of hub 320.
In the assembly process, after the hub 320 is assembled into the housing cavity 332, the spring inner surface 372 is fixedly matched with the cylinder 325 of the hub, the spring outer surface 371 is fixedly matched with the button inner cavity surface 365, the second button outer surface 362 of the button 360 passes through the first housing inner cavity surface 333 in the housing 330 through interference fit to realize the matching of the first hub inner cavity surface 323 and the second button outer surface 362, and meanwhile, under the supporting action of the elasticity of the spring 370, the matching of the first housing inner cavity surface 333 and the third button outer surface 363 is maintained, and because the width of the second housing inner cavity surface 334 is smaller than that of the first housing inner cavity surface 333 and cannot be matched with the third button outer surface 363, the limiting connection of the button 360 and the housing 330 and the limiting connection of the button 360 and the hub 320 is formed (fig. 9 and 11A).
Referring to fig. 10, after the flow diverter is loaded into the first cylindrical lumen 311 of the needle 310, the flow diverter is assembled with the delivery system.
Referring to fig. 11A, the limit connection of the button 360 and the housing 330, and the limit connection of the button 360 and the hub 320 is an initial state (i.e., a first state). Referring to fig. 11B, the assembly is brought into an activated state (i.e., a second state) by depressing the button 360 to disengage the first housing interior surface 333 from the third button exterior surface 363. Referring to fig. 11C, the retraction button 360 realizes sliding fit between the second inner cavity surface 334 of the housing and the outer surface 364 of the fourth button, and the retraction movement of the button 360 drives the needle holder 320 to retract, so that retraction of the puncture needle 310 is also realized, and meanwhile, the position of the ejector 340 remains unchanged, so that the ejector 340 pushes the drainage device out of the puncture needle 310, and further, in-situ release of the drainage device is realized. Referring to fig. 11D, after the force on button 360 is removed, the delivery system may stabilize in the state where the diverter release is complete.
The drainage device implantation method is a brand new implantation method through an external way based on the protection of the suprachoroidal space viscoelastic agent sheath. The implantation steps are as follows:
(1) Cutting the bulbar conjunctiva at a position about 4mm behind the corneoscleral limbus, about 4mm in diameter;
(2) Referring to fig. 12A, a viscoelastic (about 70 μl/eye) is injected 4mm behind the scleral limbus using a syringe or a special instrument (e.g., suprachoroidal injector);
(3) Referring to fig. 12B, the needle of the delivery system is tilted (about 10-15 ° tangential to the scleral surface) into the suprachoroidal space until the distal end of the drainage instrument passes through about 0.5mm of the anterior chamber angle;
(4) Referring to fig. 12C, the push button is retracted, releasing the drainage device in situ;
(5) Referring to fig. 12D, the puncture needle is pulled out to complete the implantation of the drainage device;
(6) Pressing the puncture, stopping bleeding and self-closing the puncture (if the puncture is not self-closing, the 10-0 suture closes the incision).
The following examples continue to be provided according to specific experiments with this embodiment.
Example 1
2 Hollowed structures are engraved on the nickel-titanium shape memory alloy pipe fitting with the outer diameter of 0.2mm and the inner diameter of 0.1mm by laser, and then 2 ribs are formed. The circumferential width of the ribs and the interval between the ribs are 1/4 of the circumference of the pipe fitting, the length of the ribs is 2.0mm, and the ribs are cut off at the positions of 0.5mm and 2.5mm at the two ends of the ribs respectively, so that the raw material of the drainage device with the length of 5.0mm is obtained. The method comprises the steps of penetrating a stainless steel wire with the outer diameter of 1.1mm into a hollow structure, supporting and expanding 2 ribs, placing the stainless steel wire in a water-cooling quenching mode after heat treatment for 15min at the temperature of 500 ℃, removing the stainless steel wire to obtain a two-dimensional planar expansion fixer pipe fitting, pickling the expansion fixer pipe fitting in pickling solution with hydrofluoric acid and nitric acid as main components to remove oxide skin formed in the heat treatment process, then carrying out electrochemical polishing in polishing solution with glacial acetic acid, ethanol, ethylene glycol and perchloric acid as main components by using an electrochemical workstation, and then cleaning to obtain the drainage device with the two-dimensional planar expansion fixer, wherein the two-dimensional planar expansion fixer and the drainage main body are integrated, the outer diameter of the drainage main body of the drainage device is 0.2mm, the inner diameter of the drainage main body is 0.1mm, the total length is 4.6mm, the distal end length is 2.5mm, the proximal end length is 0.5mm, and the expansion diameter of the expansion fixer is 1.2mm. The drainage device has good elasticity and the phase transition temperature is 28 ℃.
The drainage device in the present embodiment can perform in-situ intraocular release using the delivery system in the present embodiment. The puncture needle in the delivery system selects a 25G normal-wall needle tube (the outer diameter is 0.50mm, the inner diameter is 0.24 mm), the needle tip is a round blunt needle, the length of the puncture needle exceeding the shell in the initial state is 6mm, the length of the puncture needle exceeding the shell in the end state (the puncture needle is retracted, and the drainage device is implanted) is 1mm, namely, the maximum retraction length of the button is 5mm, the outer diameter of a thimble in the delivery system is 0.20mm, the length of the thimble exceeding the shell is 2mm, the total length of the delivery system is 100mm, and the maximum outer diameter is 22mm.
The drainage device was pushed in a conical jig using a 25G normal wall needle cannula (0.50 mm outside diameter, 0.24mm inside diameter), compressing the expansion anchor, and loading it into the needle in the desired direction (FIGS. 11A, 11D). The assembled drainage device has the distal end exposed out of the puncture needle by 1.0mm, and the drainage device can maintain the relative position with the puncture needle when the drainage device is not acted by external force.
The cleaned and sterilized drainage device and the delivery system are implanted into rabbit eyes according to the operation steps, and the delivery system has normal functions, convenient operation and accurate positioning in the operation process, so that the drainage device is successfully implanted into the expected position. The result of 1 month of follow-up shows that the drainage device has normal drainage function and good tissue biocompatibility, and the AS-OCT image (figure 13) of 1 month of follow-up shows that the drainage device does not generate position movement and the ciliary body dissociation effect of the expansion fixator is obvious.
Example two
2 Hollowed structures are engraved on the nickel-titanium shape memory alloy pipe fitting with the outer diameter of 0.3mm and the inner diameter of 0.2mm by laser, and then 2 ribs are formed. The circumferential width of the ribs and the interval between the ribs are 1/4 of the circumference of the pipe, the length of the ribs is 2.0mm, and the ribs are cut off at the positions of 0.30mm at the two ends of the ribs, so that the fixing structure raw material with the length of 2.6mm is obtained. And (3) penetrating a stainless steel wire with the outer diameter of 1.1mm into a hollow structure, supporting and expanding 2 expansion ribs, placing the stainless steel wire at the temperature of 500 ℃ for heat treatment for 15min, and then performing water cooling quenching to remove the stainless steel wire to obtain the two-dimensional planar expansion fixer with 2 expansion ribs, wherein the total length of the expansion fixer is 2.2mm, and the expansion diameter is 1.2mm.
A nickel-titanium shape memory alloy pipe fitting with the outer diameter of 0.2mm and the inner diameter of 0.1mm is cut into a short section with the length of 4.5mm to be used as a drainage main body of the drainage device, the short section is penetrated into an inner cavity of the two-dimensional plane-shaped expansion fixer, and the length of a distal end part is adjusted to be 2.0mm (namely, the distance between the drainage main body and the end part of the fixer is 1.7 mm). And spot welding any one end of the expansion fixer by using a laser welding machine (the other end is in a free state that the fixer can freely slide on the drainage main body), so as to obtain the assembly of the drainage main body and the fixer. The assembly is subjected to pickling in pickling solution with hydrofluoric acid and nitric acid as main components to remove oxide skin formed in the heat treatment and welding processes, then subjected to electrochemical polishing in polishing solution with glacial acetic acid, ethanol, ethylene glycol and perchloric acid as main components by using an electrochemical workstation, and then cleaned to obtain the drainage device with the two-dimensional planar expansion fixator, wherein the two-dimensional planar expansion fixator and the drainage body are the assembly, the outer diameter of the drainage body of the drainage device is 0.2mm, the inner diameter of the drainage body is 0.1mm, the total length is 4.5mm, the length of the distal end is 2.0mm, the length of the proximal end is 0.9mm, the expansion diameter of the expansion fixator is 1.2mm, and the drainage device has good elasticity.
The drainage device in the present embodiment can perform in-situ intraocular release using the delivery system in the present embodiment. The puncture needle in the delivery system selects a 23G thin-wall needle tube (the outer diameter is 0.60mm, the inner diameter is 0.37 mm), the needle tip is a round blunt needle, the length of the puncture needle exceeding the shell in the initial state is 5mm, the length of the puncture needle exceeding the shell in the end state (the puncture needle is retracted, and the drainage device is implanted) is 1mm, namely the maximum retraction length of the button is 4mm, the outer diameter of the thimble in the delivery system is 0.30mm, the length of the thimble exceeding the shell is 2mm, the total length of the delivery system is 100mm, and the maximum outer diameter is 22mm.
The drainage device was pushed in a conical jig using a 25G normal wall needle cannula (0.50 mm outside diameter, 0.24mm inside diameter), compressing the holder and loading it into the needle in the desired direction (fig. 11A, 11D). The assembled drainage device has the distal end exposed out of the puncture needle by 1.5mm, and the drainage device can maintain the relative position with the puncture needle when the drainage device is not acted by external force.
The cleaned and sterilized drainage device and the delivery system are implanted into rabbit eyes according to the operation steps, and the delivery system has normal functions, convenient operation and accurate positioning in the operation process, so that the drainage device is successfully implanted into the expected position. The result of 1 month of follow-up shows that the drainage device has normal drainage function, no position movement and good tissue biocompatibility.
Example III
3 Hollow structures are engraved on the nickel-titanium shape memory alloy pipe fitting with the outer diameter of 0.2mm and the inner diameter of 0.1mm by laser, and then 3 ribs are formed. The circumferential width of the ribs and the interval between the ribs are 1/6 of the circumference of the pipe, the length of the ribs is 1.7mm, and the ribs are cut off at the positions of 1.0mm and 2.0mm at the two ends of the ribs respectively, so that the raw material of the drainage device with the length of 4.7mm is obtained. The method comprises the steps of penetrating raw materials into a die, axially compressing for 0.2mm, expanding for 3 ribs, fixing, carrying out heat treatment at 500 ℃ for 15min, then carrying out water cooling quenching, removing the die to obtain a three-dimensional expansion fixer pipe with 3 expanded ribs as three-dimensional expansion fixer, carrying out acid washing on the pipe in acid washing liquid with hydrofluoric acid and nitric acid as main components to remove oxide skin formed in the heat treatment process, carrying out electrochemical polishing in polishing liquid with glacial acetic acid, ethanol, ethylene glycol and perchloric acid as main components by using an electrochemical workstation, and then washing to obtain the three-dimensional expansion fixer with the three-dimensional expansion fixer. The drainage device has good elasticity and the phase transition temperature is 28 ℃.
The drainage device in the present embodiment can perform in-situ intraocular release using the delivery system in the present embodiment. The puncture needle in the delivery system selects a 25G normal-wall needle tube (the outer diameter is 0.50mm, the inner diameter is 0.24 mm), the needle tip is a round blunt needle, the length of the puncture needle exceeding the shell in the initial state is 6mm, the length of the puncture needle exceeding the shell in the end state (the puncture needle is retracted, and the drainage device is implanted) is 1mm, namely, the maximum retraction length of the button is 5mm, the outer diameter of a thimble in the delivery system is 0.20mm, the length of the thimble exceeding the shell is 2mm, the total length of the delivery system is 100mm, and the maximum outer diameter is 22mm.
The drainage device was pushed in a conical jig using a 25G normal wall needle cannula (0.50 mm outside diameter, 0.24mm inside diameter), compressing the holder and loading it into the needle in the desired direction (distal end outside the needle). The assembled drainage device has the distal end exposed out of the puncture needle by 1.0mm, and the drainage device can maintain the relative position with the puncture needle when the drainage device is not acted by external force.
The cleaned and sterilized drainage device and the delivery system are implanted into rabbit eyes according to the operation steps, and the delivery system has normal functions, convenient operation and accurate positioning in the operation process, so that the drainage device is successfully implanted into the expected position. The result of 1 month of follow-up shows that the drainage device has normal drainage function, no position movement and good tissue biocompatibility.
In the description of the present invention, it should be understood that 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. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings are merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the device or element being referred to must have a specific orientation, be configured and operated in a specific orientation, and therefore should not be construed as limiting the present invention.
Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In the description of the present invention, the meaning of "plurality" means at least two, for example, two, three, etc., unless specifically defined otherwise.
In the present invention, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally formed, mechanically connected, electrically connected, or communicable with each other, directly connected, indirectly connected through an intervening medium, or in communication between two elements or in an interactive relationship between two elements, unless otherwise explicitly specified. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.
In the present invention, unless expressly stated or limited otherwise, a first feature "up" or "down" a second feature may be the first and second features in direct contact, or the first and second features in indirect contact via an intervening medium. Moreover, a first feature being "above," "over" and "on" a second feature may be a first feature being directly above or obliquely above the second feature, or simply indicating that the first feature is level higher than the second feature. The first feature being "under", "below" and "beneath" the second feature may be the first feature being directly under or obliquely below the second feature, or simply indicating that the first feature is less level than the second feature.
For purposes of this disclosure, the terms "one embodiment," "some embodiments," "example," "a particular example," or "some examples," etc., mean that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the invention. In this specification, schematic representations of the above terms are not necessarily directed to the same embodiment or example. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples. Furthermore, the different embodiments or examples described in this specification and the features of the different embodiments or examples may be combined and combined by those skilled in the art without contradiction.
While embodiments of the present invention have been shown and described, it should be understood that the above embodiments are illustrative and not to be construed as limiting the invention, and that variations, modifications, alternatives, and variations may be made to the above embodiments by those skilled in the art within the scope and spirit of the invention, and any such modifications, equivalents, improvements, etc. are intended to be included within the scope of the present invention.
Claims (11)
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