JPH08117267A - Aqueous humor discharge aid - Google Patents

Abstract

PURPOSE: To provide a new constitution of an aqueous humor discharge aid capable of being embedded in an eye with a surgical operation, if an interocular pressure drop cannot be well treated with an eye lotion or an internal medicine. CONSTITUTION: This discharge aid is laid through a sclera 32 in such state as extended from an anterior chamber 16 to the outside of an eyeball for the discharge of aqueous humor in the anterior chamber 16 to the outside of the eyeball. The aid is formed out of a hollow thread membrane 4 made of liquid permeable porous film having many fine holes of such diameter as allowing the passage of the humor but preventing the passage of bacteria.

Description

Detailed Description of the Invention

[0001]

TECHNICAL FIELD The present invention relates to an aqueous humor outflow device, and particularly to aqueous humor in the anterior chamber of the eye, which is preferably used for treatment when the intraocular pressure is increased due to glaucoma and the optic nerve is impaired. The present invention relates to a therapeutic device which can be effectively discharged.

[0002]

BACKGROUND ART Aqueous humor produced in the ciliary body of the eyeball passes from the posterior chamber through the iris / lens to the anterior chamber through the pupil, most of which is through the transtrabecular discharge. It is designed to be discharged to the outside of the eye, but such a discharge channel may be blocked due to various causes because it is extremely fine, and if the drainage function of the discharge channel itself deteriorates, Becomes difficult to flow out, which results in a stagnant flow of aqueous humor and high intraocular pressure. The disease in which the intraocular pressure rises for some reason and the optic nerve is impaired is called glaucoma.However, when the optic nerve is once impaired and loses visual acuity, visual acuity is almost always lost. However, if glaucoma is diagnosed, it is necessary to lower the intraocular pressure at an early stage.

In order to lower the intraocular pressure, conventionally, the method of using eye drops and drenches has been most commonly used, but such a drug lowers the intraocular pressure. However, it does not fundamentally eliminate the blockage of the aqueous humor drainage path, but it is necessary to finally provide a separate aqueous humor passage through surgical operation so that the aqueous humor flows out of the eye. There is.

By the way, in the formation of the passage (bypass) of the aqueous humor by the conventional surgical operation, a small hole is directly bored in the corner of the cornea, which is the base of the cornea, or a tube from the anterior chamber to the back of the conjunctival sac. However, such small holes tend to become clogged, making it difficult to drain the aqueous humor within 1 to 2 years, or if the tube is buried, the conjunctival sac There is a problem that the aqueous humor does not easily flow out due to the formation of a scar near the tip that is located behind the chest, which may require multiple surgeries, and in some cases there is a risk that there will be no place to cut. It was a thing.

In order to solve such a problem,
Many proposals have been made in the past. For example, in U.S. Pat. No. 4,886,488, a method of adjusting the intraocular pressure by allowing aqueous humor to flow from the anterior chamber to the nasolacrimal duct by a tube is proposed, but the structure is complicated and the operation is troublesome. In addition, there is a concern that the nasolacrimal duct may be blocked. Further, unless a precision filter is provided at the end on the side of the nasolacrimal duct, there is a risk that microorganisms may invade, which further complicates. Further, in US Pat. No. 5,300,000,
A method has been proposed in which an instrument is implanted through the sclera to allow aqueous humor to drain into the conjunctival tissue, but this method requires complicated means to regulate the outflow of aqueous humor.
There is a problem that the outflow hole is easily blocked in the conjunctival tissue. Further, in US Pat. No. 4,722,724, when the aqueous humor is allowed to flow into the tissue, in order to prevent clogging of the outflow hole,
Although the tube is put in a U-shaped band or heparin is used, there is a problem that the structure is complicated and the operation becomes extremely troublesome.

[0006]

The present invention has been made in view of such circumstances, and a subject of the present invention is to perform surgery in the case where eye drops and oral medications cannot sufficiently treat a decrease in intraocular pressure. To provide a new configuration of aqueous humor outflow device that can be implanted in the eye by static surgery to prevent postoperative clogging and scarring and to maintain normal intraocular pressure, especially while preventing bacterial contamination. Another object of the present invention is to provide a therapeutic device that effectively drains an appropriate amount of aqueous humor from the anterior chamber to the outside of the eyeball.

[0007]

In order to solve the above-mentioned problems, the present invention is arranged to penetrate the sclera from the anterior chamber to the outside of the eyeball, and the aqueous humor in the anterior chamber is stored in the eyeball. A hollow fiber membrane made of a liquid-permeable porous membrane having a large number of pores capable of passing the aqueous humor but preventing the passage of bacteria by using the aqueous humor outflow device which can be discharged to the outside. The gist is an aqueous humor outflow device that is characterized by being configured.

In one of the desirable embodiments of the aqueous humor outflow device according to the present invention, the hollow fiber membrane is open at the end portion on the side located in the anterior chamber, while the hollow fiber membrane is open. It is closed at the end located on the outside. As a result, the aqueous humor introduced from the anterior chamber through the hollow portion of the hollow fiber membrane can be effectively discharged outside the cornea through the porous membrane wall of the hollow fiber membrane.

Further, in the present invention, it is advantageous that the flow of aqueous humor in the hollow portion of the hollow fiber membrane is not hindered.
Reinforcing means capable of retaining the hollow shape of the hollow fiber membrane is provided in the portion of the hollow fiber membrane that penetrates the cornea. Specifically, the reinforcing means is composed of a coating layer having a predetermined thickness fixed to the outer peripheral surface of the hollow fiber membrane, or extrapolated and fixed to the corneal penetration portion of the hollow fiber membrane. It will consist of a reinforced tube.

Further, according to another preferred embodiment of the present invention, the reinforcing means is composed of a reinforcing tube externally inserted and fixed to the hollow fiber membrane, and the reinforcing tube is external to the eye. A structure is provided in which a plurality of liquid passage holes are provided which penetrate the tube wall of the portion located at the position to connect the gap between the reinforcing tube and the hollow fiber membrane to the outside.

Furthermore, in the present invention, it is desirable to integrally provide a protrusion protruding in the radial direction on the outer surface of the portion extending through the cornea of the reinforcing tube, and the presence of such a protrusion. According to the present invention, when the aqueous humor outflow device according to the present invention is placed through the sclera, it is effectively held by the corneal tissue, thereby effectively suppressing or preventing the aqueous humor outflow device from escaping from the cornea. It will be.

[0012]

In the aqueous humor outflow device according to the present invention as described above, the inside of the anterior chamber and the outside of the eye are communicated with each other through the hollow fiber membrane made of a liquid-permeable porous membrane, and Although the aqueous humor in the anterior chamber is allowed to flow out of the eye through the porous membrane wall of the hollow fiber membrane, the outflow rate of such aqueous humor is strongly dependent on the pores of the porous membrane. Since it is controlled by the length of the hollow fiber membrane outside the cornea,
The pressure of the aqueous humor in the anterior chamber, in other words, the intraocular pressure can be effectively maintained at a normal value, and the invasion of bacteria from outside the eyeball can be blocked by the porous membrane. The anterior chamber is never contaminated with such bacteria. Further, there is no need to provide a special valve, the structure is extremely simple, and the complexity of the operation at the time of embedding can be solved.

Moreover, since the hollow fiber membrane made of a porous membrane is arranged to penetrate the sclera,
The outflow hole of the aqueous humor can be always secured by the hollow part of the hollow fiber membrane, and in addition to causing no clogging, the aqueous humor discharge end of the hollow fiber membrane is Since it is not located in the eye, but is located outside the eyeball, especially in the conjunctival sac, the occurrence of scarring and the resulting clogging is completely eliminated.

[0014]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS In order to clarify the present invention more specifically, a typical example of the aqueous humor outflow device according to the present invention will be described below in detail with reference to the drawings.

First, FIG. 1 shows an arrangement example of the aqueous humor outflow device 2 according to the present invention in an eyeball sectional structure. There, the eye is, as is well known, the cornea 1
The anterior chamber 16 and the posterior chamber 18 are formed between the two and the crystalline lens 14 in the form of being partitioned by the iris 20, and the hair-like pattern located around the crystalline lens 14 is formed. The aqueous humor produced in the body 22 is
8 through the pupil 24 to the anterior chamber 16 through the gap between the crystalline lens 14 and the iris 20 to fill the anterior chamber 16. In the figure, 26 is the upper eyelid, 2
Reference numeral 8 is a lower eyelid.

The aqueous humor outflow device 2 according to the present invention is arranged so as to penetrate the sclera 32 (the base of the cornea 12) to extend from the anterior chamber 16 to the outside of the eyeball, and extends to the outside of the eyeball. The portion is positioned within the conjunctival sac 30. The sclera 32 refers to a portion located at the boundary between the cornea 12 and the sclera 34, as is well known.

By the way, the aqueous humor outflow device 2 according to the present invention
2 here consists of a fluid-permeable porous membrane having a large number of pores of a pore size that allows passage of aqueous humor but prevents passage of bacteria, as shown in FIG. :
A hollow fiber membrane having a size of 270 μm and an outer diameter of 0.4 mm, that is, a so-called porous hollow fiber membrane 4 having a predetermined length (L ₁ + L ₂ ) is used. In addition, this porous hollow fiber membrane 4
Is open at its base side, while its tip side is closed by a silicone-based adhesive or instant adhesive, and is shown as a blocker 10 in the figure. And, this porous hollow fiber membrane 4 On the base side of the
Over _1), for example, inner diameter: 1.0 mm, outer diameter: 1.5
Silicone tube 6 as reinforcing means for mm size
Is externally inserted, and the liquid silicone adhesive 8 filled in the gap between the inner surface of the silicone tube 6 and the outer surface of the porous hollow fiber membrane 4 is cured so that the silicone tube 6 becomes a porous hollow fiber membrane. 4 is integrally fixed to the porous hollow fiber membrane 4 so that the porous hollow fiber membrane 4 can be reinforced at the penetrating portion of the cornea.

Generally, a polymer material having good biocompatibility is used as a material for the reinforcing tube such as the above-mentioned silicone tube 6, and as such a polymer material, a silicone resin giving the above silicone tube is used. Besides, polyethylene, polypropylene, urethane resin and the like can be mentioned. In consideration of the fact that the reinforcing tube is located in the living tissue called the sclera, a soft polymer material such as silicone or urethane resin is particularly preferably used.

It should be noted that the hollow fiber membrane 4 is externally attached and fixed.
Length of silicone tube 6 (L ₁) Is here
The perforation length of the cornea of the aqueous humor outflow device 2 is made substantially equal.
Is generally selected in a length of 5 to 20 mm
Becomes In addition, the exposed portion of the hollow fiber membrane 4, in other words, the
The portion of the cone tube 6 that is not extrapolated is the sclera 3
2, located outside the conjunctival sac 30
That length; L₂The longer the
Generally, the length; L₂Is 10 to 20 mm
It is considered as a degree. Therefore, such L₁And L₂The sum of the lengths of
The length of the hollow fiber membrane 4 is generally about 15 to 40 mm.
It becomes. Also, the amount of aqueous humor discharged depends on the pores of the hollow fiber membrane.
Since it depends on the diameter, porosity, etc., such hollow fiber membranes
Determining the length of the exposed portion of the hollow fiber membrane 4 according to the property
Can be done.

On the outer surface of the silicone tube 6,
Two of the wing-shaped projections 7 having a size of 2 mm × 2 mm are symmetrically and integrally fixed to each other at a length of about 1 mm in the circumferential direction. Due to the existence of the two wing-shaped projections 7,
The silicone tube 6 can be stably fixed in a state of being penetrated through the sclera 32. In addition, the wing-shaped projection 7 is a silicone tube 6
Any shape may be used as long as it is a shape protruding radially from the outer surface of the, and in addition to an independent projection, an annular projection continuously extending in the circumferential direction may be used. Even the number of the protrusions will be appropriately selected.

Then, the aqueous humor outflow according to the present invention
The tool 2 is, as shown in FIG.
At the extrapolated portion of the silicone tube 6, the cornea
It is arranged so as to penetrate through 32, and its porous hollow
The opening on the base side of the thread membrane 4 is opened in the anterior chamber 16.
While the porous hollow fiber membrane 4 is
Closure end on the tip side where the tube 6 is not externally inserted
Minutes, in other words length: L ₂Conjunctival sac 3 outside the cornea
It is arranged so as to extend within 0. Obedience
The aqueous humor that fills the front chamber 16 is the aqueous humor outflow device 2
Through the opening of the porous hollow fiber membrane 4 of
The tip of the porous hollow fiber membrane 4 that enters and is located in the conjunctival sac 30
Of the porous wall (membrane) of the tip side portion.
Through the hole into the conjunctival sac 30, in other words, outside the sclera 32
It will be discharged to. Moreover, conjunctiva
Bacteria existing outside the cornea 12 such as the sac 30 are stored in such a chamber.
Porous wall (membrane) in the porous hollow fiber membrane 4 of the water outflow device 2
From the place where it cannot pass through the pores of
Therefore, invasion of bacteria into the anterior chamber 16 is effectively prevented.
It can be stopped.

As described above, the porous hollow fiber membrane 4 in the aqueous humor outflow device 2 according to the present invention has fine pores having a pore size that allows the aqueous humor in the anterior chamber 16 to pass through but does not allow bacteria to pass through. In other words, it has a membrane pore size capable of removing bacteria and generally has a pore size of 0.005 to 0.
A hollow fiber membrane made of a porous membrane having pores of about 3 μm is used, but normally, one that blocks standard particles of 0.2 to 0.3 μm is used. However, when it is necessary to remove not only bacteria but also viruses, a hollow fiber membrane having a smaller membrane pore size will be used. Further, the porous hollow fiber membrane 4 can be produced by a known method using a polymer material such as polyolefin, polyvinyl alcohol, polysulfone, polyacrylonitrile, cellulose acetate, polymethylmethacrylate, or polyamide. Any of various known materials can be advantageously used. Among them, polyolefin is particularly preferably used because of its high mechanical strength. Since the aqueous humor to be passed is an aqueous liquid, a hydrophilic porous fiber is preferably used as the porous hollow fiber membrane, and when a hydrophobic hollow fiber membrane is used, a known hydrophilic The chemical conversion process will be performed.

In the aqueous humor outflow device 2 according to the present invention as described above, the length of the porous hollow fiber membrane 4 located outside the eyeball on the tip side: L ₂ is passed through the hollow portion of the porous hollow fiber membrane 4. Aqueous humor led from the anterior chamber 16 is caused to flow out into the conjunctival sac 30 through the pores of the porous membrane wall,
Therefore, since it is discharged to the outside, reduction of intraocular pressure can be advantageously achieved while preventing bacterial contamination, and without causing fear of causing clogging or scarring after surgery. Moreover, since the aqueous humor is allowed to flow out through the porous membrane wall of the porous hollow fiber membrane 4, it is possible to easily discharge an appropriate amount of aqueous humor while maintaining the normal intraocular pressure. is there.

By the way, the normal eye pressure is 10 to 20 m.
Since the amount of aqueous humor flowing out in a normal eye is about 3 μL / min (1.08 mL / 6 hr), the porous hollow fiber membrane 4 used in the present invention is The following experiment was conducted to investigate whether or not the condition could be sufficiently satisfied.

That is, using the aqueous humor outflow device 2 shown in FIG. 2, a differential pressure of 10 mmHg was applied and the amount of physiological saline flowing at that time was measured. Specifically, about 13 saline solution is placed in the pipes arranged vertically.
at a height of cm, and at the lower end of the pipe,
The aqueous humor outflow device 2 shown in FIG. 2 was connected and the amount of physiological saline flowing out during 6 hours was measured. The silicone tube 6, the silicone-based adhesive 8 and the porous hollow fiber membrane 4 are all commercially available products (silicone tube;
Dow Corning Asia "Silascon", silicone adhesive; Dow Corning Asia "Silastic", porous hollow fiber membrane; Mitsubishi Rayon Co., Ltd. "Polyethylene hollow fiber membrane (EHF)" Further, as the porous hollow fiber membrane 4, the membrane pore diameter (0.1 μm and 0.
2 μm) different is used.

The results are shown in the table below. In any of the pore diameters of the porous hollow fiber membranes 4, outflow of physiological saline corresponding to the outflow of aqueous humor in normal eyes was observed. It has been found that the aqueous humor outflow device according to the present invention is effective for outflowing aqueous humor in an appropriate amount so as to maintain normal intraocular pressure.

[0027]

In the aqueous humor outflow device 2 as in the above example,
It is also possible to increase the length of the silicone tube 6 as a reinforcing tube so as to cover the porous hollow fiber membrane 4 portion located outside the eyeball. However, in that case, the silicone-based adhesive 8 is not present as much as possible between the outer surface of the porous hollow fiber membrane 4 located outside the eyeball and the inner surface of the silicone tube 6. This is preferable in order to increase the discharge amount of aqueous humor through the porous hollow fiber membrane 4.

FIG. 3 shows an example of an aqueous humor outflow device 2 in which such a silicone tube 6 is extended, in which the silicone tube 6 has substantially the same length as the porous hollow fiber membrane 4. Has been done. Then, the porous hollow fiber membrane 4 and the silicone tube 6 are fixed by a silicone adhesive 8 at a portion (length: L ₁ ) to be arranged in the tissue of the sclera 32.
A space (length: L ₂ ) that is placed inside the conjunctival sac 30 outside the eye is defined as a space, and the space passes through a plurality of liquid passage holes 6 a that penetrate through the tube wall of the silicone tube 6. The silicone tube 6 can be communicated with the outer peripheral surface side. As described above, by forming the liquid passage holes 6a in the silicone tube 6, the aqueous humor permeated and discharged from the hollow portion to the outer peripheral portion through the porous membrane wall of the porous hollow fiber membrane 4 is porous hollow fiber. It can be effectively discharged to the outside of the aqueous humor outflow tool 2 without staying in the gap between the membrane 4 and the silicone tube 6.

Further, in the aqueous humor outflow device 2 according to the present invention, the strong corneal membrane of the porous hollow fiber membrane 4 is simply as shown in FIG. 4 without the silicone tube 6 as a reinforcing tube being extrapolated as in the previous example. It is also possible to have a structure in which the porous hollow fiber membrane 4 is reinforced by fixing and forming a coating layer 9 of a predetermined thickness on the outer peripheral surface of the penetrating portion (length: L ₁ portion). The coating layer 9 is formed of various known coating agents and functions as a reinforcing means capable of maintaining the hollow shape of the porous hollow fiber membrane 4 even if the porous hollow fiber membrane 4 is placed in the corneal tissue. When such a coating layer 9 is formed on the outer surface of the porous hollow fiber membrane 4, the outflow of aqueous humor through the porous membrane wall of the porous hollow fiber membrane 4 is prevented. It is desirable that such a covering layer 9 is limited to only a portion arranged in the scleral tissue. It should be noted that the tip of the porous hollow fiber membrane 4 in the aqueous humor outflow device 2 shown in FIG. 4 is blocked by heat welding unlike the previous example.

Further, although another embodiment is shown in FIG. 5, the exemplified aqueous humor outflow tool 2 therein has one of the hollow fiber membranes 4 in a mold which provides a coating layer having a predetermined thickness and a protrusion. The silicone tube 6 and the projection 7 are integrated by arranging the parts, injecting a silicone-based adhesive or the like into the gap between the hollow fiber membrane 4 and the mold, and curing the adhesive. It was obtained in the form. As described above, the reinforcing means can be formed integrally with the hollow fiber membrane by using a mold and having a coating layer having a predetermined thickness and a protrusion if necessary.

Further, the aqueous humor outflow device 2 according to the present invention described above.
In each of the specific examples, one porous hollow fiber membrane 4 is used.
However, it is also possible to configure the aqueous humor outflow device 2 with a plurality of such porous hollow fiber membranes 4, and such a plurality of porous hollow fiber membranes 4 can be used. When they are used, if they are used in the form of being bundled as one bundle, sufficient strength of the hollow fiber membrane can be secured without providing the reinforcing means such as the silicone tube 6 and the coating layer 9 as described above. Therefore, the hollow structure can be retained in the corneal tissue.

Further, in the aqueous humor outflow device according to the present invention, as in the previous example, the porous hollow fiber membrane 4 has its opening open to the anterior chamber 16, while its closed end is the conjunctival sac 30 outside the eye. Although it is arranged so as to be located inside, it is not limited to this, and if the aqueous humor is allowed to flow out through the porous membrane wall of the porous hollow fiber membrane 4. The porous hollow fiber membrane 4 can be incorporated as an aqueous humor outflow device in various forms. For example, when the hollow fiber membrane (4) is curved at the center and folded in half, the curved portion is An aqueous humor outflow device having a structure in which the openings at both ends of the hollow fiber membrane (4) are positioned inside the conjunctival sac 30 outside the eyeball while being positioned inside the anterior chamber 16 can also be adopted.

Although the typical construction of the aqueous humor outflow device according to the present invention has been described above in detail, it goes without saying that the present invention is not subject to any restrictions by the description of the above specific examples. It's a place. Further, in addition to the above-described specific examples and examples, the present invention may be added with various changes, modifications and improvements based on the knowledge of those skilled in the art without departing from the spirit of the present invention. It should be understood that

[Brief description of drawings]

FIG. 1 is an eyeball cross-sectional explanatory view showing an arrangement state of an aqueous humor outflow device according to the present invention.

2 is a longitudinal cross-sectional explanatory view showing one embodiment of the aqueous humor outflow device according to the present invention used in FIG. 1. FIG.

FIG. 3 shows another embodiment of the aqueous humor outflow device according to the present invention,
It is a longitudinal cross-sectional explanatory view corresponding to FIG.

FIG. 4 is a partial cross-sectional explanatory view showing another different embodiment of the aqueous humor outflow device according to the present invention.

FIG. 5 is an explanatory longitudinal sectional view showing still another different embodiment of the aqueous humor outflow device according to the present invention.

[Explanation of symbols]

2 Aqueous humor outflow tool 4 Porous hollow fiber membrane 6 Silicone tube 6a Liquid passage hole 7 Wing protrusion 8 Silicone adhesive 9 Covering layer 10 Obstruction object 12 Corneal 14 Lens 16 Anterior chamber 18 Rear chamber 20 Iris 22 Ciliary body 24 Pupil 26 Upper eyelid 28 Lower eyelid 30 Conjunctival sac 32 Sclera 34 Sclera

 ─────────────────────────────────────────────────── ─── Continuation of the front page (72) Inventor Kuroji Kuroda 2-11-33 Noritake Shinmachi, Nishi-ku, Nagoya-shi, Aichi Tome Technology Co., Ltd.

Claims (7)

[Claims] 1. An aqueous humor outflow device which is disposed so as to penetrate the cornea from the anterior chamber to the outside of the eyeball and discharges the aqueous humor in the anterior chamber to the outside of the eyeball. The aqueous humor outflow device comprises a hollow fiber membrane composed of a liquid-permeable porous membrane having a large number of pores capable of preventing the passage of bacteria. 2. The hollow fiber membrane is opened at an end located on the side located in the anterior chamber, and is closed at an end located on the outside of the eyeball. Aqueous spill. 3. The aqueous humor outflow device according to claim 1 or 2, wherein a reinforcing means capable of holding the hollow shape of the hollow fiber membrane is provided at a portion of the hollow fiber membrane that penetrates the cornea. 4. The aqueous humor outflow device according to claim 3, wherein the reinforcing means is composed of a coating layer having a predetermined thickness fixed to the outer peripheral surface of the hollow fiber membrane. 5. The aqueous humor outflow device according to claim 3, wherein the reinforcing means is constituted by a reinforcing tube which is externally inserted and fixed to a portion of the hollow fiber membrane that penetrates the cornea. 6. The reinforcing means is extrapolated to the hollow fiber membrane,
A plurality of fixed reinforcement tubes that penetrate the tube wall of the portion of the reinforcement tube that is located outside the eyeball to allow the gap between the reinforcement tube and the hollow fiber membrane to communicate with the outside. The aqueous humor outflow device according to claim 3, wherein a liquid passage hole is provided. 7. The aqueous humor outflow device according to claim 4, wherein the outer surface of the corneal penetrating portion of the reinforcing tube is integrally provided with a protrusion protruding in the radial direction.