CN116942409A

CN116942409A - Ophthalmic implant

Info

Publication number: CN116942409A
Application number: CN202211496276.4A
Authority: CN
Inventors: 潘再良
Original assignee: Suzhou Meishi Medical Partnership LP
Current assignee: Suzhou Meishi Medical Partnership LP
Priority date: 2022-11-25
Filing date: 2022-11-25
Publication date: 2023-10-27

Abstract

The application relates to the technical field of medical equipment, and provides an ophthalmic implant. The ophthalmic implant includes a drainage body. The drainage body is in a tubular arrangement, a slot is formed in the side wall of the drainage body, the slot is communicated with the inside of the drainage body and the outside of the drainage body, and the side wall is in a spiral arrangement along the extension direction of the drainage body. The helical nature of the sidewall may increase the amount of aqueous humor flow while reducing the rate of aqueous humor flow into the ophthalmic implant, thereby increasing drainage effects and reducing potential damage to adjacent tissue caused by flow-related suction.

Description

Ophthalmic implant

Technical Field

The application relates to the technical field of medical equipment, in particular to an ophthalmic implant.

Background

Glaucoma is an intraocular disease with visual field defect and vision loss caused by optic nerve injury, is a second approximately blind disease next to cataract on the global scale, and has the pathological characteristics of irreversibility, improvement or alleviation but incurability and recovery. Glaucoma occurs and develops primarily from the optic nerve's tolerance to pressure damage, manifested as elevated intraocular pressure. Whereas elevated ocular pressure is primarily due to the blockage of the aqueous circulatory pathway within the eye, one of the most important factors responsible for glaucomatous optic nerve damage, and so far the only factor that can be effectively controlled. Effectively controlling ocular pressure depends on how obstructed the aqueous humor circulation pathway, which is 80-95% of the volume of all aqueous humor circulation pathways, the aqueous humor is produced from the ciliary body and re-enters the posterior aspect and passes over the pupil to the anterior chamber, enters Schlemm's canal (Schlemm) via the trabecular meshwork of the anterior chamber, collects aqueous humor in Schlemm's canal (Schlemm), and circulates to the posterior aqueous humor vein, intra-scleral plexus vein, etc.

In the prior art, an implanted drainage implantation bracket is generally adopted to be implanted in the eyes of a human body, and an aqueous humor outflow channel is rebuilt, so that the intraocular pressure is reduced, and the aim of treatment is fulfilled. The existing drainage implantation stent has closed dead angles, the drainage process is easy to produce residues, and the drainage effect is poor.

Disclosure of Invention

In view of the above, the technical problem to be solved by the present application is to provide an ophthalmic implant capable of increasing drainage effect.

In order to solve the technical problems, the application adopts a technical scheme that: an ophthalmic implant is provided that includes a drainage body. The drainage body is in a tubular arrangement, a slot is formed in the side wall of the drainage body, the slot is communicated with the inside of the drainage body and the outside of the drainage body, and the side wall is in a spiral arrangement along the extension direction of the drainage body.

In some embodiments of the application, the drainage body is arcuate along the extension direction of the drainage body; preferably, the arc of the diversion body is 60 ° to 120 °.

In some embodiments of the application, the drainage body is made of tubing, and the grooves are formed in the side walls of the tubing by a cutting method.

In some embodiments of the application, the drainage body is wound from a strip of sheet material with two long sides of the strip of sheet material as the edges of the two sides of the slot.

In some embodiments of the application, the ophthalmic implant further comprises a groove wall connecting structure connecting both side edges of the groove.

In some embodiments of the application, the slots extend at the same width along the extension of the proximal to distal ends of the drainage body; and/or the side walls extend at the same width in the direction of extension of the proximal end to the distal end of the drainage body.

In some embodiments of the application, the width of the slot is tapered along the extension of the proximal end to the distal end of the drainage body; and/or the width of the side wall becomes gradually smaller along the extension direction from the proximal end to the distal end of the drainage body.

In some embodiments of the application, the width of the slot is 0.1mm to 0.6mm and the width of the sidewall is 0.1mm to 0.6mm.

In some embodiments of the application, the ophthalmic implant further comprises a tissue protection structure disposed at the distal end of the drainage body.

In some embodiments of the application, the slot extends to the distal end of the drainage body, and the tissue protection structure is disposed at the distal end of the sidewall of the drainage body distal end; preferably, the slots do not extend to the distal end of the drainage body so that the side walls of the drainage body distal end are in a continuous loop configuration.

In some embodiments of the application, the ophthalmic implant further comprises a delivery device connection structure provided at the proximal end of the drainage body for connection to a delivery device; preferably, the slot does not extend to the end of the proximal end of the drainage body so that the side wall of the proximal end of the drainage body is in a continuous annular configuration, and the conveyor connection includes a groove disposed on the side wall.

In some embodiments of the application, the material of the guide body comprises one of a memory metal or stainless steel; preferably, the drainage body inner and outer surfaces are coated with heparin hydrogel coating; preferably, the outer diameter of the drainage body is 0.2mm to 0.6mm and the inner diameter of the drainage body is 0.1mm to 0.5mm.

The beneficial effects of the application are as follows: in contrast to the prior art, in the present application, an ophthalmic implant is provided comprising a drainage body. The drainage body is in a tubular arrangement, a slot is formed in the side wall of the drainage body, the slot is communicated with the inside of the drainage body and the outside of the drainage body, and the side wall is in a spiral arrangement along the extension direction of the drainage body. The helical nature of the sidewall may increase the amount of aqueous humor flow while reducing the rate of aqueous humor flow into the ophthalmic implant, thereby increasing drainage effects and reducing potential damage to adjacent tissue caused by flow-related suction.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for the description of the embodiments will be briefly described below, and it is apparent that the drawings in the following description are only some embodiments of the present application, and other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art. Wherein:

FIG. 1 is a front view of an ophthalmic implant according to one embodiment of the present application;

FIG. 2 is a top view of an ophthalmic implant according to one embodiment of the present application;

FIG. 3 is a right side view of an ophthalmic implant according to an embodiment of the present application;

FIG. 4 is a cross-sectional view of an ophthalmic implant according to one embodiment of the present application;

FIG. 5 is another view of an ophthalmic implant according to an embodiment of the present application;

FIG. 6 is a partial enlarged view of A;

FIG. 7 is a schematic view of the structure of an ophthalmic implant using a connecting structure according to an embodiment of the present application;

FIG. 8 is a front view of an ophthalmic implant according to another embodiment of the present application;

fig. 9 is a top view of an ophthalmic implant according to another embodiment of the present application.

Detailed Description

In order that the above objects, features and advantages of the application will be readily understood, a more particular description of the application will be rendered by reference to the appended drawings. It is to be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the application. It should be further noted that, for convenience of description, only some, but not all of the structures related to the present application are shown in the drawings. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.

In a healthy eye, when new aqueous humor is secreted by the epithelial cells of the ciliary body, aqueous humor flows out of the anterior chamber of the eye, through the trabecular meshwork, and into Schlemm's canal (Schlemm). Excess water enters the venous blood stream from schlemm's canal and is carried out of the eye with the venous blood stream.

When the natural drainage system of the eye fails to work properly, the pressure in the eye begins to rise, and prolonged high pressure in the eye tends to cause loss of vision area until blindness. The ophthalmic implant may thus be inserted into schlemm's canal, trabecular meshwork tissue, and anterior chamber of the eye to facilitate drainage of aqueous humor from the anterior chamber of the eye, thereby relieving intraocular hypertension. Based on this, the present application provides an ophthalmic implant.

Referring to fig. 1 to 4, fig. 1 is a front view of an ophthalmic implant according to an embodiment of the present application; FIG. 2 is a top view of an ophthalmic implant according to one embodiment of the present application; FIG. 3 is a right side view of an ophthalmic implant according to an embodiment of the present application; fig. 4 is a cross-sectional view of an ophthalmic implant according to an embodiment of the present application.

The ophthalmic implant includes a drainage body 100. The drainage body 100 is in a tubular arrangement, the side wall 20 of the drainage body 100 is provided with a slot 30, the slot 30 communicates the inside of the drainage body 100 with the outside of the drainage body 100, and the side wall 20 is in a spiral arrangement along the extension direction of the drainage body 100.

Specifically, as shown in fig. 1, the drainage body 100 may be approximately cylindrical in shape throughout its length, extending in a spiral form in the circumferential direction of the cylinder. In other words, the drainage body 100 has a hollow structure, and the drainage body 100 is spirally disposed in the axial direction of the drainage body 100.

Placing drainage body 100 in schlemm's canal in the eye, the aqueous humor can enter the venous blood flow from any direction through slot 30 in sidewall 20 of drainage body 100, and the helical nature of sidewall 20 can increase the amount of aqueous humor flow while reducing the rate of aqueous humor flow into the ophthalmic implant, thereby increasing drainage effects and reducing potential damage to adjacent tissue caused by flow-related suction.

In one embodiment, referring to fig. 1, the flow guide 100 is curved in the axial direction of the flow guide 100.

Specifically, the drainage body 100 is configured in an arc shape to simulate the anatomy of the human eye, particularly the anatomy of the schlemm's canal that is transplanted in, so that the drainage body 100 can be better fused in the schlemm's canal in the eye, and the foreign body sensation in the eye can be reduced.

When the drainage body 100 is arcuate and flexible enough, it can be shaped to conform to schlemm's canal when implanted in an eye.

In one embodiment, the arc-shaped current collector 100 may be formed by cutting the current collector 100 into a spiral shape using a laser, and thermally curing the current collector 100 into a desired arc shape.

In one embodiment, the arc of the flow body 100 is 60 ° to 120 °.

Specifically, the included angle formed by the connecting lines of the two ends of the drainage body 100 and the circle center is the radian of the drainage body 100, the length of the drainage body 100 corresponds to the radian of the drainage body 100, and the longer the length of the drainage body 100 is, the larger the radian is, the shorter the length of the drainage body 100 is, and the smaller the radian is. When in implantation, the drainage body 100 can be formed into a circle with radian of 60 degrees, 70 degrees, 80 degrees, 90 degrees, 100 degrees, 110 degrees, 120 degrees and the like around the schlemm's canal, the limitation is not limited herein, and the drainage body 100 with different radians can be manufactured according to actual requirements when in actual use.

In one embodiment, the material of the drainage body 100 includes one of memory metal or stainless steel.

In particular, the materials used for the ophthalmic implants should have a good biocompatibility. The material may be a metal material such as memory metal, stainless steel, tantalum, gold, titanium, or a nonmetal material, and is not limited herein, and may be selected according to actual needs in actual use.

The drainage body 100 made of stainless steel is bent during manufacturing, has a certain radian and can be directly implanted into schlemm's canal in an eye.

The drainage body 100 made of memory metal is in a vertical contracted state during daily preservation and transportation, can be in a vertical shape before being implanted into eyes, and can be restored to a bent shape for use based on the influence of human body temperature after being implanted into eyes to a desired position.

In one embodiment, referring to fig. 5, fig. 5 is another view of an ophthalmic implant according to an embodiment of the present application. The drainage body 100 is in a tubular arrangement, the side wall 20 of the drainage body 100 is provided with a slot 30, the slot 30 communicates the inside of the drainage body 100 with the outside of the drainage body 100, and the side wall 20 is in a spiral arrangement along the extension direction of the drainage body 100. In this embodiment, the slot 30 is open and there is no connecting structure 40 between the slot walls. When an ophthalmic implant is implanted in schlemm's canal, there may be a possibility of rotation in one direction, and the provision of the spiral-shaped drainage body 100 may allow the water to flow directly out of the slot 30, increasing drainage.

In one embodiment, the drain 100 is made from tubing, and the slot 30 is formed in the sidewall of the tubing in a cut-out manner. The drainage stent 100 may be a sidewall 20 formed by a 360 ° helical cut. The remaining portion after the tube cutting is completed is the sidewall 20, and the vacant portion after the tube cutting is completed is the slot 30.

In particular, the drainage body 100 of the tubing may be processed using a laser cutting method. The laser cutting head emits a laser beam to the pipe, and a predetermined cutting curved surface is set to control the laser cutting head to move in a horizontal transverse direction, a horizontal longitudinal direction and/or a vertical direction and/or swing around a horizontal axis parallel to the horizontal transverse direction, and simultaneously control the guide body 100 to rotate 360 degrees along a numerical axis extending in the vertical direction, so that the guide body 100 forms a continuous and uniformly distributed 360-degree spiral side wall 20.

In one embodiment, the drainage body 100 is wound from a strip of sheet material with two long sides of the strip of sheet material as the two side edges of the slot 30.

Specifically, the guide body 100 may be manufactured by softening a strip and then rotating the strip in one direction to form the spiral sidewall 20, or rotating the strip around a cylinder of a suitable diameter to form the spiral sidewall 20.

In one embodiment, referring to fig. 7, fig. 7 is a schematic structural view of an ophthalmic implant using a connecting structure 40 according to an embodiment of the present application. The drainage body 100 is in a tubular arrangement, the side wall 20 of the drainage body 100 is provided with a slot 30, the slot 30 communicates the inside of the drainage body 100 with the outside of the drainage body 100, and the side wall 20 is in a spiral arrangement along the extension direction of the drainage body 100. In this embodiment, the ophthalmic implant further includes a groove wall connecting structure 40 connecting both side edges of the groove 30. By providing the connecting structure 40 between the side wall 20 and the slot 30, the spiral shape of the drainage body 100 can be maintained, the shape of the drainage body 100 is prevented from being changed after the ophthalmic implant is implanted into the eye, and the stability of the drainage body 100 can be ensured.

Wherein the connecting structure 40 is integral with the side wall 20.

In one embodiment, the drain 100 is made from tubing and the slot 30 is formed in the sidewall 20 of the tubing in a cut-out fashion. When the slot 30 is cut, the connecting structure 40 is formed.

In medicine, the trunk of the patient is taken as a reference object, one end close to the trunk is a near end, and the end far from the trunk is a far end.

In one embodiment, referring to fig. 2-4, the slots 30 extend at the same width along the proximal-to-distal extension of the drainage body 100; and/or along the proximal to distal extension of the drainage body 100, the side walls 20 extend the same width. In other words, the width of the slot 30 and the sidewall 20 in the flow director 100 is always the same. Ensuring uniform flow rate of the aqueous humor. In another embodiment, the width of the slot 30 is tapered along the extension of the drainage body 100 from the proximal end to the distal end; and/or the width of the sidewall 20 is tapered in the direction of extension of the drainage body 100 from the proximal end to the distal end. Specifically, the proximal end of the drainage body 100, the greater width of the slot 30 and sidewall 20, allows the aqueous humor to flow quickly out of the anterior chamber of the eye into schlemm's canal; the smaller width of the distal end of drainage body 100, slot 30 and sidewall 20 allows the aqueous humor to slowly flow out of schlemm's canal into the venous blood flow.

In one embodiment, referring to fig. 1-7, the sidewall 20 has a spiral width of 0.1mm to 0.6mm and the sidewall 20 has a spiral pitch of 0.1mm to 0.6mm.

In one embodiment, referring to fig. 5 and 6, fig. 6 is an enlarged view of part of a. The slot 30 extends to the distal end of the drainage body 100. The distal end of the drainage body 100, i.e., the end of the sidewall 20, presents a tip 21, and the tip 21 may scratch the schlemm's canal after the ophthalmic implant is inserted into the eye.

Further, in one embodiment the ophthalmic implant further comprises a tissue protection structure (not shown) disposed at the distal end of the drainage body 100. Providing a tissue protection structure at the distal end of the drainage body 100 prevents the tip 21 from scratching the schlemm's canal and damaging the eye.

In one embodiment, the distal end of the drainage body 100 is coated with a coating using a configured medical fluid directly sprayed onto the distal end of the drainage body 100, thereby providing a tissue protection structure.

In one embodiment, the tissue protecting structure may be a passivation treatment of the drainage body 100, and may be a rounding of the tip 21; the drainage 100 may be cleaned with passivation water to passivate it.

In one embodiment, tissue protection structures may also be provided integrally with the ophthalmic implant.

In one embodiment, referring to fig. 8 and 9, fig. 8 is a front view of an ophthalmic implant according to another embodiment of the present application, and fig. 9 is a top view of an ophthalmic implant according to another embodiment of the present application. The slot 30 does not extend to the distal end of the flow body 100 so that the side wall 20 of the distal end of the flow body 100 is in a continuous loop structure 22. In particular, the distal end of the drainage body 100 may be left uncut while the tubular drainage body 100 is cut, allowing it to remain in the annular configuration 22; it is also possible to wind the strip into a loop 22 at the end of winding, so as to avoid damage to the eye by the ophthalmic implant.

In one embodiment, referring to fig. 1 and 5, the ophthalmic implant further includes a delivery device coupling structure 10 disposed at the proximal end of the drainage body 100 for coupling to a delivery device (not shown). The slot 30 does not extend to the distal end of the proximal end of the flow body 100 such that the side wall 20 of the proximal end of the flow body 100 is a continuous annular structure and the conveyor attachment structure 10 includes a groove disposed on the side wall 20.

Specifically, the conveyor connecting structure 10 is disposed on one side of the proximal end of the drainage body 100, and the conveyor connecting structure 10 is an open groove. After the drainage body 100 is implanted in schlemm's canal, water may also pass through the conveyor connection structure 10 into the drainage body 100 and then into the side wall 20 of the drainage body 100. The ophthalmic implants may be used in combination with methods of treating human eye diseases and/or disorders (e.g., glaucoma). The ophthalmic implant is connected to the delivery device connection 10 of the drainage body 100 in a snap-fit connection. The ocular implant is advanced into schlemm's canal of the eye using the conveyor until the ocular implant reaches the desired location, and the conveyor is withdrawn from the ocular implant. When the ophthalmic implant in the eye is damaged or cannot be used further, the drainage body 100 can be removed by the conveyor. By providing the conveyor connection 10, the use and removal of the ophthalmic implant may be facilitated.

The delivery device is connected to the ophthalmic implant by the delivery device connection 10 such that the drainage body 100 passes through the incision in the cornea and into the eye, the advancement mechanism of the delivery device is controlled by one hand to advance the drainage body 100 into schlemm's canal while the second hand holds the gonioscopy to visualize the implantation of the ophthalmic implant into schlemm's canal, and the delivery device is disconnected from the ophthalmic implant after the ophthalmic implant has completely entered schlemm's canal.

The conveyor connecting structure 10 may be an open groove provided at the proximal end of the drainage body 100, and the number of open grooves may be set according to practical situations. In the illustrated embodiment, the number of open grooves is two. In other embodiments, the number of open trenches is one.

In one embodiment, the outer diameter of the flow body 100 is 0.2mm to 0.6mm and the inner diameter of the flow body 100 is 0.1mm to 0.5mm.

Specifically, the drainage body 100 is positioned in schlemm's canal and supports the canal, and the thickness of the wall of the drainage body 100 may be 0.1mm, that is, the inner diameter of the drainage body 100 is 0.3mm when the outer diameter of the drainage body 100 is 0.4 mm. The outer diameter of the drainage body 100 may be in the range of 0.2mm to 0.6mm, and the inner diameter of the drainage body 100 may be in the range of 0.1mm to 0.5mm, and may be specifically set according to the use requirement in actual use, which is not limited herein.

In one embodiment, both the inner and outer surfaces of the drainage body 100 are coated with a heparin hydrogel coating.

Specifically, the whole drainage body 100 is coated with the heparin hydrogel coating, so that the drainage body 100 has better biocompatibility when being implanted into eyes, early and delayed thrombosis can be avoided, long-term contact with tissues after implantation can be avoided, the tissues can be guided to expand and grow in the body, and fibrosis and scar of surrounding tissues are reduced. In view of the stability of the surface binding of the hydrogel coating, a heparinized star polyethylene glycol hydrogel coating may be employed.

In one embodiment, one or more therapeutic agents may be applied to the inner and outer surfaces of the drainage body 100 in combination with the use of an ophthalmic implant, and the therapeutic agent may be an agent for treating glaucoma, such as prostaglandins, carbonic anhydrases, etc.

Method of operation of an ophthalmic implant to treat an embodiment of glaucoma:

the drainage body 100 is arranged in a predetermined resting shape which mimics the anatomy of the human eye, in particular the anatomy of schlemm's canal to be transplanted in. The surgeon uses a surgical knife to make an incision in the cornea of the eye and then advances the drainage body 100 through the conveyor into schlemm's canal of the eye, positions the proximal inlet portion of the drainage body 100 within the anterior chamber of the eye, positions the intermediate portion of the drainage body 100 within schlemm's canal, and positions the distal portion of the drainage body 100 within the anterior chamber of the eye. When the ophthalmic implant is in place within the eye, the ophthalmic implant will support trabecular meshwork tissue and schlemm's canal tissue, and will provide improved communication between the anterior chamber and schlemm's canal (via the trabecular meshwork tissue) and between the pockets or compartments along schlemm's canal. The aqueous humor may flow through the hollow portion 30 of the drainage body 100, out of schlemm's canal, into the venous blood stream, and out of the eye with the venous blood stream.

The foregoing description is only of embodiments of the present application, and is not intended to limit the scope of the application, and all equivalent structures or equivalent processes using the descriptions and the drawings of the present application or directly or indirectly applied to other related technical fields are included in the scope of the present application.

Claims

1. An ophthalmic implant, comprising:

the drainage body is in a tubular arrangement, a slot is formed in the side wall of the drainage body, the slot is communicated with the inside of the drainage body and the outside of the drainage body, and the side wall is in a spiral arrangement along the extending direction of the drainage body.

2. The ophthalmic implant of claim 1, wherein the drainage body is arcuate along the extension of the drainage body;

preferably, the arc of the diversion body is 60 ° to 120 °.

3. The ophthalmic implant of claim 1 wherein the drainage body is made from tubing and the slots are formed in a cutting process on a sidewall of the tubing.

4. The ophthalmic implant of claim 1, wherein the drainage body is wound from a strip of sheet material with two long sides of the strip of sheet material as the two side edges of the slot.

5. The ophthalmic implant of claim 1 further comprising a channel wall connecting structure connecting two side edges of the channel.

6. The ophthalmic implant of claim 1 wherein the ophthalmic implant is a lens,

the slots extend with the same width along the extending direction from the proximal end to the distal end of the diversion body; and/or

The side walls extend at the same width in the direction of extension of the proximal end to the distal end of the drainage body.

7. The ophthalmic implant of claim 1 wherein the ophthalmic implant is a lens,

the width of the slot is gradually reduced along the extending direction from the proximal end to the distal end of the diversion body; and/or

The width of the side wall is gradually reduced along the extending direction from the proximal end to the distal end of the diversion body.

8. The ophthalmic implant of claim 6 or 7, wherein the width of the slot is 0.1mm to 0.6mm and the width of the sidewall is 0.1mm to 0.6mm.

9. The ophthalmic implant of claim 1, further comprising a tissue protection structure disposed at a distal end of the drainage body;

preferably, the slot extends to the end of the distal end of the flow body, and the tissue protection structure is disposed at the end of the sidewall of the distal end of the flow body.

10. The ophthalmic implant of claim 1, wherein the slot does not extend to the distal end of the drainage body such that the sidewall of the drainage body distal end is in a continuous loop-like structure.

11. The ophthalmic implant of claim 1, further comprising a conveyor connection structure provided at a proximal end of the drainage body for connection with a conveyor;

preferably, the slot does not extend to the end of the proximal end of the flow director such that the side wall of the proximal end of the flow director is a continuous loop-like structure, and the conveyor connection includes a groove disposed on the side wall.

12. The ophthalmic implant of claim 1, wherein the material of the drainage body comprises one of a memory metal or stainless steel;

preferably, the drainage body inner surface and the drainage body outer surface are both coated with heparin hydrogel coatings;

preferably, the outer diameter of the drainage body is 0.2mm to 0.6mm, and the inner diameter of the drainage body is 0.1mm to 0.5mm.