An aqueous humor drainage device

Abstract

The present application provides an aqueous humor drainage device, which comprises two drainage tubes arranged in parallel along the radial direction and a support body embracing the two drainage tubes, the drainage tubes are curved in an arc shape along the axial direction to adapt to the physiological curvature of the sclera, the support body has a bottom supported on the inner concave surface of the arc-shaped curve of the drainage tubes and embracing parts extending from the two sides of the bottom along the outer side walls of the two drainage tubes away from each other. The present application adopts two polymer thin tubes with hollow channels arranged in parallel as the drainage tubes and the support body structure design embracing the drainage tubes, which makes full use of the flexibility of the polymer tubes and the toughness of the support body, improves the compatibility of the surrounding tissues and the device, and can continuously maintain good drainage effect.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of medical devices, and particularly relates to an aqueous humor outflow device. BACKGROUND

[0002] Drainage devices play an important role in the treatment of glaucoma. Currently, the XEN drainage tube made of pigskin gelatin cross-linked by glutaraldehyde is the only MIGS surgical product in China that uses the subconjunctival pathway for drainage through the internal approach. The main principle is to directly connect the anterior chamber and the subconjunctival cavity with the drainage tube to increase the outflow of aqueous humor and reduce intraocular pressure.

[0003] However, there is currently no commercial product that can drain aqueous humor from the suprachoroidal space. Although there are not many devices that can connect the anterior chamber and the suprachoroidal space to reduce intraocular pressure, and even some early cases did not achieve the expected results due to various reasons. However, the scientific nature of this mechanism for reducing intraocular pressure is beyond doubt, and existing data shows that it has fewer side effects. The treatment concept is not to modify the eye's own aqueous humor circulation pathway, but to create a bypass, and even at the same time, it can also drive the circulation of the original pathway. It is more adaptable to different races or types of glaucoma and is worth developing suitable equipment to provide more individualized options for the majority of glaucoma patients. For example, CN 110913809A discloses a glaucoma drainage device, which includes an elongated body extending axially from a distal end to a proximal end, and the distal end forms a wedge shape with a terminal leading edge. During implantation, the wedge shape can promote penetration into and expansion of the suprachoroidal space tissue. After implantation, the elongated body connects the anterior chamber and the suprachoroidal space. At least one open slot in the elongated body promotes the flow of aqueous humor from the anterior chamber to the suprachoroidal space through the open slot, thereby reducing intraocular pressure. However, it is made of flexible medical polymeric material, and the front end is easily compressed by the ciliary muscle during use, making it difficult to maintain effective support. SUMMARY

[0004] To solve the above problems, the present application provides an aqueous humor outflow device that connects the anterior chamber and the suprachoroidal space to drain aqueous humor and reduce intraocular pressure, which is suitable for the treatment of glaucoma. The purpose of the present application is achieved by the following technical solutions:

[0005] The present application provides an aqueous humor outflow device, which includes two drainage tubes arranged side by side in the radial direction and a support body that surrounds and supports the two drainage tubes. The drainage tubes are arc-shaped curved in the axial direction to adapt to the physiological curvature of the sclera. The support body has a bottom that supports the inner concave surface of the arc-shaped curvature of the drainage tube and a clamping portion formed by clamping arms extending from both sides of the bottom. The inner walls of the clamping arms extend along the outer walls of the two drainage tubes that are away from each other.

[0006] Further, the two drainage tubes have the same radial and axial dimensions.

[0007] Further, the two drainage tubes are made of medical polymer materials, and the support body is made of medical inert metal materials or medical inert polymer materials; preferably, the two drainage tubes are made of one or more of medical cellulose acetate, medical polyacrylonitrile, medical polysulfone, medical polymethacrylate, medical polyether sulfone and medical silica gel; preferably, the support body is made of one or more of medical pure titanium, medical titanium alloy, medical stainless steel, medical zirconium and medical zirconium alloy; and the support body is made of one or more of polyethylene, polypropylene, polyacrylic resin, polyformal, polymethyl methacrylate, etc.

[0008] Further, the tube wall of the two drainage tubes has sub-micron micropores.

[0009] Further, the bottom of the support body is provided with one or more shunt holes penetrating through the thickness thereof.

[0010] Further, the clamping part comprises a first clamping section, a second clamping section and a third clamping section, the first clamping section clamps the axial head end of the two drainage tubes, the third clamping section clamps the axial middle part of the two drainage tubes, and the second clamping section clamps the axial tail end of the two drainage tubes, and the first clamping section, the second clamping section and the third clamping section have axial gaps therebetween.

[0011] Further, the clamping part has a fourth clamping section, the fourth clamping section clamps the axial middle part of the two drainage tubes, and the fourth clamping section is located between the second clamping section and the third clamping section; preferably, the first clamping section, the second clamping section, the third clamping section and the fourth clamping section are equidistantly spaced apart along the axial direction.

[0012] Further, the bottom of the support body is provided with a flow guide groove extending axially from the head end to the tail end on the side face away from the drainage tubes.

[0013] Further, the support body and the two drainage tubes have equal axial extension lengths, and each has a length of 4-8 mm; the outer diameter of a single drainage tube is 0.1-0.4 mm, and the inner diameter of a single drainage tube is 0.08-0.38 mm; the maximum span of the support body in the radial direction is 0.4-0.9 mm, and the thickness of the support body is 0.2-0.5 mm.

[0014] The present application has the following advantages:

[0015] (1) The application adopts two polymer fine tubes with hollow channels arranged in parallel as drainage tubes and a support structure surrounding and supporting the drainage tubes, fully utilizes the flexibility of the polymer tubes and the toughness of the support structure, improves the compatibility of the surrounding tissue and the device, and can continuously maintain good drainage effect;

[0016] (2) The support structure is adopted, the head end support structure itself can also be used as a marker to control the implantation depth of the drainage device during implantation, and the head end clamping part is located near the scleral spur during implantation, and the scleral spur and the ciliary muscle near the scleral spur provide good support under the compression of the scleral spur and the ciliary muscle near the scleral spur;

[0017] (3) The drainage tube wall of the application has a sub-micron pore structure, aqueous humor can be shunted from the hollow structure, and can also be infiltrated from the tube wall micropores, the support body bottom is provided with a drainage shunt hole, and the multi-channel drainage design can realize the natural infiltration and natural outflow of aqueous humor, reduce the incidence of fibrosis, reduce scars, and thus reduce the occurrence of side effects.

[0018] (4) The application adopts an implementation scheme of connecting the anterior chamber and the suprachoroidal space for aqueous humor drainage to reduce the intraocular pressure, which is another path, does not affect the original aqueous humor circulation system of the patient's eye, has excellent pressure reduction effect, and also has good effect on patients with angle-closure glaucoma, and has a wide range of indications; The application implements a corneal internal approach device, which creates a small surgical interface, does not need to open the conjunctiva and the sclera, and greatly reduces the risk of external infection of the cornea, and the operation is simple. BRIEF DESCRIPTION OF DRAWINGS

[0019] Figure 1 The aqueous humor drainage device is shown as a preferred embodiment of the application;

[0020] Figure 2 The aqueous humor drainage device is shown as Figure 1 The aqueous humor drainage device in another angle and the drainage tube surface micropore structure schematic view. DETAILED DESCRIPTION

[0021] The technical solutions of the preferred embodiments of the application will be described clearly and completely below with reference to the drawings in the embodiments of the application. Obviously, the described embodiments are only a part of the embodiments of the application, not all the embodiments. Based on the embodiments of the application, all other embodiments obtained by those skilled in the art without creative labor are within the protection scope of the application.

[0022] The aqueous humor drainage device provided by the embodiment comprises two drainage tubes, i.e., a first drainage tube 101 and a second drainage tube 102, which are arranged in parallel in the radial direction, and a support body 200 which embraces and supports the two drainage tubes, the first drainage tube 101 and the second drainage tube 102 are curved in an arc shape in the axial direction to adapt to the physiological curvature of the sclera, and the support body 200 has a bottom 220 which supports the inner concave surface of the arc-shaped bending of the drainage tubes and a clamping part 220 which is formed by clamping arms extending from both sides of the bottom 220, the bottom 220 also has the same arc-shaped bending structure as the drainage tubes in the axial extension direction, so that the whole drainage device can adapt to the physiological curvature of the sclera and eyeball, meet the physiological curve of the human eyeball, improve the adaptability to the eyeball, reduce the foreign body sensation of the eye and the damage to the eyeball; the inner side walls of the clamping arms extend along the outer side walls of the two drainage tubes which are away from each other, the clamping arms on both sides of the bottom are generally arranged in a symmetrical structure, and the clamping arms preferably embrace the two drainage tubes in an interference embracing manner, the free ends of the clamping arms on both sides should extend along the tube wall of the drainage tube beyond the outer end point of the diameter of the connection point of the outer wall of the two drainage tubes, so as to fully embrace the two drainage tubes and avoid the jump of the drainage tube.

[0023] In the illustrated embodiment, a plurality of shunt holes 221 which penetrate the thickness of the bottom 220 of the support body are arranged on the bottom 220 of the support body to adapt to the positions where the first drainage tube 101 and the second drainage tube 102 are connected to the bottom 220 of the support body; the clamping part 210 has a plurality of clamping segments, as shown in the figure, the clamping part has a first clamping segment 211, a second clamping segment 214, a third clamping segment 212 and a fourth clamping segment 213, the first clamping segment 211 clamps the axial head end of the two drainage tubes, the second clamping segment 214 clamps the axial tail end of the two drainage tubes, the third clamping segment 212 and the fourth clamping segment 213 clamp the axial middle part of the two drainage tubes, and there is an axial spacing between adjacent clamping segments, and the axial extension lengths of the four clamping segments can be the same or different.

[0024] In other embodiments, the fourth clamping segment 213 can not be arranged, and only the third clamping segment 212 is arranged in the middle part; or in some embodiments, the clamping part can have only two clamping segments, or the clamping part can have an integrated clamping structure in which the clamping arms extend directly from the head end to the tail end, as long as the clamping and support of the support body on the two drainage tubes can be ensured. However, compared with the structure with multiple clamping segments, the material application is less, the overall weight of the drainage device is lighter, the weight feeling of the patient after implantation is lighter, and better drainage effect can be achieved.

[0025] In the preferred embodiment, the first clamping segment 211, the second clamping segment 214, the third clamping segment 212 and the fourth clamping segment 213 are distributed at equal distances in the axial direction.

[0026] In a preferred embodiment, the two drainage tubes have the same radial and axial dimensions, and the head end and tail end of the support body are flush with the head end and tail end of the drainage tubes.

[0027] In a preferred embodiment, the two drainage tubes are made of medical polymer materials, and the support body is made of medical metal materials; preferably, the two drainage tubes are made of one or more of medical cellulose acetate, medical polyacrylonitrile, medical polysulfone, medical polymethacrylate, medical polyether sulfone, and medical silica gel; preferably, the support body is made of one or more of medical pure titanium, medical titanium alloy, medical stainless steel, medical zirconium, and medical zirconium alloy.

[0028] In a preferred embodiment, the tube wall of the two drainage tubes has sub-micron micropores, and the bottom of the support body is provided with a flow guide groove 222 extending axially from the head end to the tail end on the side opposite to the drainage tubes. The tube wall has sub-micron micropores, and the aqueous humor can be shunted along the polymer hollow thin-diameter tube and can also infiltrate along the tube wall micropores. A flow guide channel is also formed between the two drainage tubes and the bottom of the support body. Meanwhile, the bottom of the support body has an axially extending flow guide groove 222. Such a structural design is very beneficial to draining the aqueous humor and guiding the aqueous humor to pass through the drainage device into the suprachoroidal space to reduce the intraocular pressure.

[0029] In a preferred embodiment, the bottom 220 of the support body 200 is designed to adapt to the curvature structure of the tube part itself of the first drainage tube 101 and the second drainage tube 102 with the flow guide groove 222 as the division line, so that the support body can better hold and fix the first drainage tube 101 and the second drainage tube 102.

[0030] In a preferred embodiment, the support body and the two drainage tubes have equal axial extension lengths, both being 4-8 mm; the outer diameter of a single drainage tube is 0.1-0.4 mm, and the inner diameter of a single drainage tube is 0.08-0.38 mm; the maximum span of the support body in the radial direction is 0.4-0.9 mm, and the thickness of the support body is 0.2-0.5 mm. When the drainage device is implanted into the suprachoroidal space, the head end clamping part of the support body can serve as a marker to control the implantation depth of the drainage device. The overall length of the drainage device in the anterior chamber is about 0.2-0.8 mm, and the extension length of each clamping segment in the axial direction is 0.3-1.0 mm. The clamping segment overfits the hollow polymer tube. The position of the head end metal clamping segment of the drainage device is just near the scleral spur when the drainage device is implanted. Under the compression of the ciliary muscle at the scleral spur and nearby, the clamping segment supports the drainage device. The clamping part 220 supports the whole device after implantation, so that the drainage tube is not subjected to extrusion by the eye muscles and maintains the structural integrity. The shunt hole 221 is a circular hole, an elliptical hole, or a waist-shaped hole, and extends in the axial direction with a length of 0.3-1.0 mm.

[0031] Finally, it should be pointed out that the above preferred embodiments are only used to illustrate the technical solutions of the present application but not to limit the present application. Although the present application has been described in detail by the above preferred embodiments, those skilled in the art should understand that various modifications can be made in form and details without departing from the scope of the present application defined by the claims; the sizes described in the drawings and the embodiments are not related to specific objects and are not used to limit the protection scope of the present application, and the sizes of the objects can be selected and changed according to actual needs.

Claims

1. A type of aqueous humor drainage device, characterized in that, The device includes two drainage tubes arranged radially side by side and a support body that circumferentially supports the two drainage tubes. The drainage tubes are curved in an arc shape along the axial direction to adapt to the physiological curvature of the sclera. The support body has a bottom supported on the concave surface of the curved drainage tube and a clamping part formed by clamping arms extending from both sides of the bottom. The walls of the two drainage tubes have submicron-level micropores. The bottom of the support body has one or more diversion holes that penetrate its thickness. The clamping part includes a first clamping section, a second clamping section, a third clamping section, and a fourth clamping section. The first clamping section clamps the axial head end of the two drainage tubes, the second clamping section clamps the axial tail end of the two drainage tubes, the third clamping section and the fourth clamping section clamp the axial middle part of the two drainage tubes, and the fourth clamping section is located between the second clamping section and the third clamping section. The first clamping section, the second clamping section, the third clamping section and the fourth clamping section are distributed at equal intervals along the axial direction. The two drainage tubes are made of one or more of the following materials: medical cellulose acetate, medical polyacrylonitrile, medical polysulfone, medical polymethyl methacrylate, medical polyethersulfone, and medical silicone. The support is made of one or more of the following medical inert metal materials: medical pure titanium, medical titanium alloy, medical stainless steel, medical zirconium, and medical zirconium alloy. Alternatively, the support is made of one or more of the following medical inert polymer materials: polyethylene, polypropylene, polyacrylic acid resin, polyoxymethylene, and polymethyl methacrylate.

2. The aqueous humor drainage device according to claim 1, characterized in that, The two drainage tubes have the same radial and axial dimensions.

3. Aqueous drainage device according to claim 1 or 2, characterized in that, The bottom of the support body has a guide groove extending axially from the head end to the tail end on the side facing away from the drainage pipe.

4. Aqueous drainage device according to claim 1 or 2, characterized in that, The axial extension lengths of the support and the two drainage tubes are equal, both being 4–8 mm; the outer diameter of a single drainage tube is 0.1–0.4 mm, and the inner diameter of a single drainage tube is 0.08–0.38 mm; the maximum span of the support in the radial direction is 0.4–0.9 mm, and the thickness of the support is 0.2–0.5 mm.

Images