CN108743016B - Glaucoma miniature shunt device with variable structure - Google Patents

Abstract

The invention discloses a glaucoma micro shunt device with a variable structure, which is characterized in that: the flow divider is a shape memory long component, the interior of the flow divider is hollow tubular, and the flow divider comprises a head end, a body part and a tail part and can be used as a fluid channel; the head end is designed to be a first main flow port, the head end is designed to be an outward expanding type opening pipe, the outer diameter of the port is 0.5-0.7 mm, and the port is used as an inflow port of aqueous humor; the body part comprises a fixing part, a branch flow and a second main flow channel; the tail part is an extended passage. The technical scheme of the invention improves the defects of large trauma and slow recovery of the traditional operation, reduces the secondary operation risk in the minimally invasive operation, avoids the problems of implantation dislocation, displacement, blockage and the like, improves the operation safety and reduces the infection risk after the operation.

Description

Glaucoma miniature shunt device with variable structure

Technical Field

The invention relates to a device for ophthalmologic treatment, in particular to a variable-structure glaucoma micro shunt device.

Background

Glaucoma is an ocular disease characterized by progressive, irreversible vision loss characterized by optic nerve damage. The occurrence mechanism is not clear, but at least the mechanism is clearly related to intraocular pressure elevation (IOP), the disease is the third approximately blindness disease worldwide, the prevalence rate of open-angle glaucoma of people over 40 years old in China is 2.3%, the blindness rate is about 15%, and the disability rate is nearly 30%. According to the calculation, with the acceleration of the aging of the population in China, 1640 ten thousand open-angle glaucoma patients are expected to be present in China by 2020, and nearly 246 ten thousand blind people and over 490 ten thousand visual handicapped people are generated. Glaucoma occurs at any age but is 6 times more likely in people >60 years of age.

Glaucoma is divided into the two main categories of open-angle and closed-angle glaucoma, with > 98% of the aqueous humor exiting the eye through the trabecular meshwork of the anterior chamber angle and the Schlemm's canal (the most prominent route, especially in the elderly) or the ciliary body surface and choroidal blood vessels. Early stage primary open angle glaucoma often has no subjective symptoms, accounting for about 60% to 70% of all glaucomas. 2/3 glaucoma patients exhibit elevated intraocular pressure (>21mmHg) and are under-drained of aqueous humor and normal production of aqueous humor by the ciliary body, usually with visual field loss felt only by the patient when there is significant atrophy of the optic nerve.

At present, the clinical treatment scheme for glaucoma is mainly that in the case of insignificant or no medication, surgery is necessary to reduce intraocular pressure. Current surgical treatment modalities include:

1) laser treatment of glaucoma: the laser iridoplasty and peritomy, laser trabeculoplasty, laser photocoagulation of the retina and the like belong to the classic anti-glaucoma surgical treatment method, namely, a part of trabecular tissue is cut off to establish a channel from the inside of an eye to the subconjunctival part outside the eye wall, so that the aqueous humor in the eye can be drained from another path to achieve the effect of reducing the intraocular pressure, but serious complication, namely malignant glaucoma, can exist after the surgery. Statistically, 80% of malignant glaucoma occurs after trabeculectomy.

2) Shunt implantation: from the non-limiting aqueous humor drainage device of 1960 to the limiting aqueous humor drainage device of 1980, more ExPRESS drainage nails are used in China at present. That is, establishing a drainage system within the eye to direct aqueous humor from the anterior chamber to other locations within or around the eye for reabsorption by the lymphatic system, is a filtering bleb-dependent external drainage procedure. Although effective in reducing intraocular pressure, the conventional problems such as superficial anterior chamber and choroid detachment are easy to occur in the early stage of operation, and complications are easy to occur for a long time.

3) Minimally Invasive Glaucoma Surgery (MIGS): in the new stage of glaucoma surgery, the outflow of aqueous humor is improved by various methods under the premise of not damaging conjunctiva and sclera as much as possible, and the aim of reducing intraocular pressure is finally achieved. Can solve the problems of high operation technical requirement, large wound and slow recovery in the traditional operation.

For example, chinese patent application 201621332267.1 discloses a glaucoma drainage device which only achieves the purpose of lowering intraocular pressure, while enhancing the stability of the drainage device; also, as disclosed in chinese patent application 96236289.1, the ocular pressure regulator for glaucoma has a reasonable structure, a significant and reliable curative effect, a simple and convenient method for implanting eyes, a reliable retention, a small volume, a light weight, no foreign body sensation or toxic and side effects, and a strong popularization and application value, and opens up a new treatment path for glaucoma treatment, but it fails to reduce the risk of secondary operation in minimally invasive surgery, and has the problems of implantation dislocation, displacement, blockage, and the like.

Disclosure of Invention

Aiming at the defects of the prior art, the invention aims to reduce the secondary operation risk in the minimally invasive surgery, avoid the problems of implantation dislocation, displacement, blockage and the like, improve the safety of the surgery and reduce the infection risk after the surgery while improving the large trauma and slow recovery of the traditional surgery.

The invention solves the technical problems in the prior art by adopting the following technical scheme:

a structurally variable glaucoma mini-shunt device characterized in that: the flow divider is a shape memory long component, the interior of the flow divider is hollow tubular, and the flow divider comprises a head end, a body part and a tail part and can be used as a fluid channel; the head end is provided with a first main flow port which is of an outward expanding type opening tubular structure, and the outer diameter of the port of the head end is preferably 0.5-0.7 mm and is used as an inflow port of aqueous humor; the body part comprises a fixing part, a branch flow and a second main flow channel; the tail part is an extended passage.

The inner diameter of the head end port is larger than the pipe diameter of the body part; the body part is provided with fixing pieces, the fixing pieces exist in pairs, and at least 1 pair of fixing pieces exist at the position 1-2 mm below the head port; the number of pairs of the fixing pieces is 1 or more, and the fixing pieces are symmetrically distributed on the outer wall of the pipe along the central axis of the pipe; the fixing piece is designed in an open mode and used for branching flow, and can also be a closed cylinder and only used as a fixing piece.

The fixing piece structure is a variable structure, is closed in the pipe wall of the body part of the component before being implanted, and is in an expanded state after being implanted, namely, the fixing piece structure is gradually expanded along the pipe shaft body, and the maximum expansion area does not exceed the outer diameter of the port.

The body part is also provided with branch flows, the branch flows are communicated with the internal passages of the hollow pipe of the flow dividing device, are distributed discontinuously along the circumference of the body part of the flow dividing device and are positioned close to the tail part of the pipe of the flow dividing device, so that flow dividing is promoted.

The body part also comprises a second main flow port positioned at the tail end of the flow dividing device, and the inner diameter of the second main flow port is smaller than that of the first main flow port; the tail is irregular and is designed into one or more grooves and used as an extension passage, so that the risk of water outlet blockage can be reduced.

The length of the tail part is not greater than 1/6 of the length of the main body component, and the tail part can be a blunt port which extends outwards from the second main flow port and also can be an external tail part with the edge being processed by chamfering or rounding; the longitudinal central axis of the tail part can be in the same plane with the central axis of the main body or on a different plane.

The shunting device is different in structure before implantation and after implantation, the structural design before implantation is favorable for the component to move forward, the structure after implantation is favorable for fixation, and the length range of the component after implantation is 6-7 mm.

The main material of the shunt device is a high molecular material or a metal material which accords with biocompatibility or a composite material of the materials; the material comprises a thermal sensing material and a non-thermal sensing material; the polymer material is a thermal-sensitive shape memory polymer material, and the metal material is a thermal-sensitive shape memory alloy material.

The fixing piece is made of a shape memory alloy material which accords with biocompatibility.

The surface treatment is carried out on part or the whole of the flow dividing device; the processing mode of the long component structure is one-step forming or step-by-step forming.

The invention has the advantages and positive effects that:

1. the miniature shunt device is improved aiming at the existing glaucoma shunt device with unchanged structure, and is an elongated tubular component with a changeable structure before and after implantation, and the function is realized by adopting a shape memory alloy material as a fixing piece material. The improved device can better meet the requirements of smooth implantation of an operator in an operation and fixation of the device after shape recovery on one hand, thereby reducing the risk of displacement of the device after the operation; on the other hand, the implant is used as a metal material, so that the visualization of the operation process is facilitated, and the risk of implantation dislocation is reduced.

2. This patent has carried out central symmetry formula design improvement with the traditional lasso design of mounting, and the mounting structure after the improvement makes the device more firm.

3. The distribution position of the lateral branch flow designed by the patent is protruded to be close to the far end (tail part) of the pipe, and the traditional branch flow is generally uniformly distributed on the whole surface of the pipe body. The improved design can generate a pressure gradient, which is beneficial to the outflow of fluid and achieves the effect of promoting the flow division.

4. The improved irregular tail part is not beneficial to the proliferation of surrounding tissue cells on one hand, can better prevent the second main flow passage from being blocked, and achieves the purpose of reducing the risk of water outlet blockage; on the other hand, the tail part has non-sharp taper, which is beneficial to the implantation of the device.

Drawings

FIG. 1 is a schematic view of the shunt device prior to implantation;

FIG. 2 is a schematic view of a non-thermal material processing shunt device after implantation;

FIG. 3 is a schematic view of the thermal sensing type material processing shunt device after implantation;

FIG. 4, FIG. 5, FIG. 6 are schematic distribution views of the fixing members;

FIG. 7, FIG. 8, FIG. 9 are schematic views of the shape of the fixing member;

FIGS. 10 and 11 are schematic views of the shape of the branched flow;

fig. 12, 13 and 14 are schematic diagrams of the tail part of the shunt device.

Detailed description of the preferred embodiments

In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention are further described below with reference to the drawings in the embodiments of the present invention.

The present invention is a miniature shunt device for treating glaucoma, the shunt device being an elongate member, the first main flow port of the shunt device being positioned in the anterior chamber of the eye when implanted, and the second end main flow port of the shunt device being positioned in the retrobulbar space. Thus, the shunt device is used to drain aqueous humor fluid from the anterior chamber of the eye to the retrobulbar space, providing the desired pathway for fluid.

As shown in fig. 1 and 2, the flow divider is a shape-variable elongated member, which includes a head end 1, a body 2, and a tail 3, wherein the head end 1 is an outward-expanding open pipe, and as a first main flow port, a fluid inlet, and an inner diameter of the port should be larger than a pipe diameter of the body 2, so as to facilitate fluid entering, and an outer diameter of the port at the head end is 0.5-0.7 mm.

The somatic part 2 includes mounting 21, and mounting 21 exists in pairs at least 1 ~ 2mm below the head end 1, and along the pipe center pin symmetric distribution on 2 tub outer walls of somatic part, mounting 21 can be 1 to also can be many pairs. The fixing piece can be designed in an open mode and can be used for branch flow, and the fixing piece can also be a closed column body and only serves as a fixing piece. In one example (see fig. 3) the fixture 21 has 2 pairs of cylindrical fixtures below the head end 1 that communicate with the inside diameter of the pipe and may act as a split inlet. As another example (see fig. 4), there are 1 pair of fixing members 21 under the head end 1, the expanding direction is favorable for the fluid to enter, and there are 1 pair near the tail end, the expanding direction is opposite to the advancing direction, and the function of the branch outlet is provided. Another embodiment is symmetrical about the tube center axis at 90 degrees to provide greater stability of the elongate member after implantation. The anchor 21 is designed with a variable configuration which facilitates the passage of the elongate member into tissue in the closed state prior to implantation and in the expanded state after implantation. As shown in fig. 4, the span-type column structure has a spread area spread along with the implantation space (which facilitates the forward movement and enhances the fixing ability), and the hook structure design not only can firmly position but also can avoid the damage to the tissue.

The shape of the expanded state of the fixing element is determined by the designed shape of the fixing element. The fixing piece can be cylindrical or in other shapes, and is chamfered and has no sharp edge. In an embodiment, the extension is not larger than the outer diameter of the head end 1, the tip of the wing may be hooked back towards the head end 1 of the component or may be parallel to the surface of the body 2 (see fig. 7), and in another embodiment, the tip of the wing is in a Y-branch shape (see fig. 8).

The fixing piece 21 is made of shape memory alloy material and has the functions of stabilizing the shunt and assisting implantation and positioning. When it returns to its shape, it comes into contact with the inner wall of the relevant tissue, achieving a fixing action, making it easy to place and able to fix without displacement. Moreover, the shape memory alloy material can be clearly imaged by technologies such as X-ray photography, scintigraphy and ultrasonic OCT, and is beneficial to determining the implantation position and postoperative follow-up.

The processing mode of the fixing piece 21 can be realized by integrally processing the component itself, and can also be realized by post-processing matching or bonding. As an example, a component with a groove is obtained by adopting a laser cutting or ablation technology, then the nickel-iron wire component with the shape memory function after heat treatment and shaping is processed in a welding mode, and the curvature of the whole structure is changed after the shape is recovered.

The body 2 also comprises a branch flow 22, the branch flow 22 being discontinuously distributed along the circumference of the element and being able to communicate with the internal passage of the tube, acting as a lateral diversion passage, positioned close to the end of the tube, facilitating the diversion. The design of the branch flow, including shape, size, and number, can have an effect on the proliferation of surrounding tissue. The branch flow 22 is of circular orifice design as shown in the example (fig. 11). In other examples, the branch flow 22 is designed as a rectangle (fig. 10). The branched flow feature can eliminate material by precision laser drilling or solution dipping.

The body 2 further comprises a second main flow opening 23 at the end orifice of the flow dividing means, the inner diameter of the second main flow opening being smaller than the diameter of the head end as the first main flow opening.

The tail 3 is an extended passage which should have properties that promote the passage of fluid, reducing the risk of outlet blockage. The tail part 3 is an extension of the second main flow opening, and the implementation manner of the tail part can be obtained by integral forming through 3D micro-forming, and can also be obtained by injection molding or thermal forming. The shape of the extension passage may be one groove or a plurality of grooves designed on the pipe fitting tail part 3, the extension passage may be an outward protruding port of the second main flow port 23 (fig. 12 and 14), or an external tail part with a chamfered or rounded edge, and a longitudinal central axis of the external tail part may be in the same plane as a central axis of the main body or different. According to an embodiment, the extension passage is designed as a shovel-shaped groove bevel opening, the extension line of the center line of the groove and the extension line of the center line of the body part have a certain angle, the angle ranges from 20 degrees to 60 degrees, and the implantation site of the structure is lower than the first main flow channel and the second main flow channel (as shown in fig. 3). Another example describes the fabrication of a plurality of drainage grooves (fig. 13) in the member second primary flow port 23 to promote fluid egress.

The main material of the shunt device is a high molecular material and a metal material which accord with biocompatibility or a composite material of the materials. The material includes thermal type material and non-thermal type material. The thermal sensing material comprises a thermal sensing type shape memory polymer material and a shape memory alloy material. The thermal sensitive polymer material with shape memory function is selected from polyurethane, polylactic acid, aliphatic polyester, poly foreign body diene, polynorbornene, polylactide, polypropylene, and polycaprolactone. The shape memory alloy material includes, for example, nickel titanium based, copper based, iron based, nickel aluminum based intermetallic compounds, and the like. The non-heat induction type material includes, for example, polyimide, silicone, PTFE, ePTFE, various fluoropolymers, FEP, PMMA, acrylic, polyethylene terephthalate (PET), Polyethylene (PE), and parylene. The metal material includes uranium, stainless steel, platinum, stainless steel, molybdenum, a shape memory alloy material, and the like. The preferred thermal sensitive shape memory polymer material and shape memory alloy material have the following implantation characteristics: the body structure is different before and after implantation, the implanted component has self-expansion along with temperature, the longitudinal central axis A has a certain curvature, the bending degree can cover 0-180 degrees, in some examples, the curvature range is 20-60 degrees, and the curvature radius corresponds to the radius of a functional area of the eye, thereby being beneficial to the implantation of the shunt and the fixation of the implanted pipe fitting. As an example, a thermal sensitive type high molecular material polyurethane granule and a common high molecular material polyimide are respectively adopted to obtain the required long member structure after being prepared by a 3D micro-molding process (as shown in figure 1), wherein the body part 2 of the polyurethane member is subjected to micro-molding through heat treatment to obtain a bendable member of the pipe body, the longitudinal central axis A of the pipe after the shape is recovered has a curvature of 20-60 degrees (as shown in figure 3), and the body part 2 of the polyimide member is not changed.

The elongate member may be partially or wholly surface treated. The surface treatment may be a treatment aimed at increasing anti-tissue proliferation, hydrophilicity, hydrophobicity or increasing the slippery properties of the surface; the surface treatment mode can be surface coating of a therapeutic agent or an anti-inflammatory or anticoagulant material, and can also be electrochemical surface treatment, laser surface treatment or chemical vapor deposition CVD. Plasma treatment of a partial area of the body with plasma surface CF4+ O2 as described in one example increases the hydrophobic character and reduces tissue inflammation. Still another example uses an electrochemical polishing process to polish the interior surface to increase the smoothness characteristics of the interior surface to facilitate fluid flow. Another example is the use of bulk PEG coating to increase tissue compatibility and reduce foreign body sensation.

The processing mode of the flow dividing device can be one-step forming or step-by-step forming. The one-step molding can be a precise material reduction technology such as laser cutting, a precise material increase technology such as 3D micro-molding, injection molding and extrusion molding, and can also be a composite technology of the technologies. Alternative stepped forming modes can be assembly matching forming including welding forming, bonding forming and even fastening connection forming.

It should be emphasized that the embodiments described herein are illustrative rather than restrictive, and thus the present invention is not limited to the embodiments described in the detailed description, but also includes other embodiments that can be derived from the technical solutions of the present invention by those skilled in the art.

Claims (6)

1. A structurally variable glaucoma mini-shunt device characterized in that: the shunt device is an elongated component made of shape memory materials, the interior of the shunt device is hollow and tubular, and the shunt device comprises a head part, a body part and a tail part; the head end is provided with a first main flow port which is of an outward expanding type opening tubular structure, and the outer diameter of a head end port is 0.5-0.7 mm and is used as an inflow port of aqueous humor; the body part comprises a fixing part, a branch flow and a second main flow port;

the inner diameter of the head end port is larger than the pipe diameter of the body part; the body has fasteners, the fasteners being present in pairs, at least 1 pair being present below the head port; 1 pair of fixing pieces is arranged at a position 1-2 mm below the head port, the number of pairs of the fixing pieces is 1 or more, and the fixing pieces are symmetrically distributed on the outer wall of the pipe along the central axis of the pipe of the flow dividing device;

the body part is also provided with branch flows, the branch flows are communicated with the internal passage of the hollow pipe of the flow dividing device, are distributed discontinuously along the circumference of the body part of the flow dividing device, are positioned close to the tail part of the pipe, and are arranged in an even number along two sides of the central pipe axis of the flow dividing device to promote flow dividing;

the fixing part structure is a variable structure, is closed in the pipe wall of the body part of the component before implantation, is in an expanded state after implantation, namely is gradually expanded along the pipe shaft body, the maximum expansion area does not exceed the outer diameter of the port, and the length of the shunt device after implantation is 6-7 mm;

the tail part is an extension passage;

the tail is an extension of the second main flow port;

the shape of the extension passage is one or more grooves designed at the tail part of the pipe fitting, or the shape of the extension passage is an outward protruding port of the second main flow port;

the extension passage is designed as a shovel-type inclined opening of the groove, a certain angle is formed between the center line of the groove and the extension line of the center line of the body part, the angle range is 20-60 degrees, and the implantation site of the structure is lower than the first main flow channel and the second main flow channel; the shunting device is subjected to surface treatment; the surface treatment mode comprises surface coating of PEG, electrochemical polishing treatment and plasma treatment by adopting plasma surface CF4+ O2.

2. The glaucoma microshunt device of claim 1 wherein: the body portion includes a second primary flow port at the end of the flow distribution device, the second primary flow port having an inner diameter smaller than the first primary flow port.

3. The glaucoma microshunt device of claim 1 wherein: the tail is an irregular tail, and the irregular tail is designed into one or more grooves.

4. The glaucoma microshunt device of claim 1 wherein: the tail portion has a length not greater than 1/6 of the length of the body member and is a blunt port extending outward from the second main flow port; the tail part is an external structure with the edge processed by chamfering or rounding.

5. The glaucoma microshunt device of claim 1 wherein: the main material of the shunt device is a high molecular material or a metal material which accords with biocompatibility or a composite material of the materials; the polymer material is a thermal-sensitive shape memory polymer material, and the metal material is a thermal-sensitive shape memory alloy material.

6. The glaucoma microshunt device of claim 1 wherein: the fixing piece is made of a shape memory alloy material which accords with biocompatibility.

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