KR20040024873A - Method and intra-sclera implant for treatment of glaucoma and presbyopia - Google Patents

Abstract

The present invention relates to an intrascleral graft device (10) and a method of transplantation for use in treating intraocular pressure and presbyopia. The implantation device includes a body 46 and a projection 48 that protrudes from the body and secures the implantation device in the space 19 formed in the sclera 16. On the other hand, it can also provide a dosage function for long-term administration to the tissue around the implant.

Description

METHODS AND INTRA-SCLERA IMPLANT IMPLANT FOR TREATMENT OF GLAUCOMA AND PRESBYOPIA}

Glaucoma is an eye disease that gradually causes vision loss. This loss of vision is caused by damage to the optic nerve, which acts like a wire that carries images from the eye to the brain. High intraocular pressure is one of the major causes of neurodestruction, often accompanied by glaucoma and causing this blindness. Intraocular pressure rise is thought to occur when the drainage tube of the eye becomes clogged with time. Intraocular pressure rises to the point where nerve breakdown occurs because the proper amount of fluid does not exit the eye in a steady state. Failure to detect and treat this excess intraocular pressure results in progressive loss of vision. This loss of vision sometimes occurs over a long period of time. However, in glaucoma, intraocular pressure usually rises sharply. In particular, a sudden increase in intraocular pressure occurs when the drainage of the eye is blocked.

Drugs are often used when intraocular pressure builds up slowly. In patients suffering from a sudden increase in intraocular pressure or a rise in intraocular pressure reaching a dangerous level over a long period of time, severe eye drops or permanent vision loss can occur.

Recently, surgery is used as an intraocular pressure therapy. In recent years, radial incisions in the anterior sclera, known as anterior ciliary incisions, have been reported to lower IOP. Unfortunately, for patients receiving these treatments, there was a problem of scarring remaining for a long time after the incision. As a result, there is a risk that the intraocular pressure rises again after surgery, resulting in loss of vision.

Another problem affecting a patient's vision is presbyopia in which the lens of the patient loses elasticity. Loss of elasticity makes it difficult to focus on nearby objects. Presbyopia may appear sudden to a patient, but in reality it occurs over a long period of time and can be seen as a loss of vision due to significant loss of elasticity of the lens in the mid forties.

Presbyopic treatments include prescription glasses, bifocal glasses, contact lenses, and laser surgery. However, corrective lenses are inconvenient to wear and there is a risk of vision loss if the laser surgery of the lens is mistaken.

In addition, many eye diseases require long-term administration to maintain vision. It would be desirable to be able to easily install a device that can dose medication directly to the eye over a long period of time while helping to correct intraocular pressure and vision problems.

Accordingly, there is a continuing need for treatments that require simple surgical treatments that have long lasting effects in reducing or reducing intraocular pressure and correcting presbyopia without the need for prescription lenses or reducing the need for prescription lenses. Providing a dosage system that can adjust dosages and times while helping to relieve intraocular pressure, as well as other eye diseases that require accurate and long-term dosing, will further enhance this therapeutic effect.

Recently, surgical procedures and implants have been developed to treat presbyopia.

US Patent 6,280,468 to Schachar discloses scleral prostheses for treating presbyopia and other eye diseases. This patent treats presbyopia in a patient by placing a prosthesis around the pupil in several pockets slightly smaller than the implant, exerting pressure on the sclera to restore the working distance of the ciliary muscle. However, there is a problem in that the pockets are arranged circumferentially around the pupil or in front of the eye, but there is no means for holding the implant in the pupil for a long time, thereby reducing or eliminating the effect of the implant. In addition, there is a fear that the implant may be damaged by using a tunnel smaller than the implant. This patent also has no means of administering from implants. In addition, there is a risk of the implant detaching, so if the implant is out of position and pokes the outside of the eye, the implant must be removed from the eye. In addition, circumferential placement of the implants is not effective for internal drainage or pressure reduction.

Nordquist, US Pat. No. 6,102,045, discloses a device and method for lowering intraocular pressure. However, the implant of this patent penetrates the anterior eye through the pores around the cornea. In this patent, placing an implant in the sclera makes it difficult to correct presbyopia, and because of its precise positioning and direct access to the anterior eye, it is more difficult to accurately position. In addition, it is difficult to administer the drug to the eye, and if the eye is directly through the front and outside of the eye, there is a high risk of infection of the anterior eye.

US Patent No. 6,079,417 to Fugo discloses a method and apparatus for altering the shape of the cornea. However, in this patent it is difficult to lower the intraocular pressure by increasing the discharge from the inside of the eye. Designed to mount directly to the cornea.

Baerveldt, US Pat. No. 5,178,604, describes the use of implants that lower intraocular pressure and increase drainage causing glaucoma. However, direct communication with the inside of the eye is simply a tube, which does nothing to correct presbyopia.

Therefore, there is a continuing need for reliable surgical methods and prostheses to assist the physician in stopping cruel procedures resulting in vision loss and eye damage in patients suffering from intraocular pressure accumulation. Such devices should be relatively easy to insert into the eye by trained surgeons. Such devices and procedures should avoid delicate eye structures and prevent infection by preventing direct contact between the outside of the eye and the inside of the eye. It would be more useful to provide a system for administering drugs from the implant to the eye. In addition, devices implanted in this manner should be sized to have a fixture that permanently holds the implant properly, precluding the need to replace the implant and maintaining corrective vision.

This application claims the priority of US Provisional Patent Application 60 / 310,027, filed August 3, 2001.

TECHNICAL FIELD The present invention relates to a scleral implant device, and more particularly, to a device implanted in a sclera to lower excessive intraocular pressure causing glaucoma and to treat presbyopia or to treat loss of coordination of eyes.

1 is a perspective view showing the placement of multiple implants in four quadrants of the eye;

2 is a cross-sectional view showing placement of an implant in the sclera;

3 is a perspective view of an implant showing the anchor and the coating;

Figure 4 is a perspective view showing the relationship of the implantation device having an inner container containing the medicine with the outside;

5 is a perspective view of another case of an implant device with an anchor externally;

6 is a perspective view of another implantable device with a cylindrical body and with anchors protruding from the surface thereof;

The above and other problems are overcome by methods and scleral implants for treating glaucoma and presbyopia. To insert the implant, incisions must be made radially in front of the sclera. Multiple incisions are made in the sclera, the best of which are four, one per quadrant.

Once the incisions are formed in the appropriate quadrants to properly extend towards the back of the eye, one implant is placed in each of the incision spaces. Next, the scleral flaps are pushed toward the eye surface to recombine the scleral flap with a suture or other suture to suture the scleral incision.

The implant is most preferably formed integrally with a material that does not react when contacted with body tissue. Preferred materials are one or a combination of hydroxyapatite, silicone, polymethylmethacrylate, acryl, tantalum.

A single body of implant may have a serration or one or more apertures formed to contact and fix the sclera tissue. In addition, the body of the implant may contain drugs to be slowly administered to the tissues of the eye, or they may form internal receptors containing drugs or slowly dissolving drug coatings to adjust the amount and time of the implant from the implant to the patient's eye and body. You can also have your medications taken.

Accordingly, it is an object of the present invention to provide a reliable surgical method by which a trained surgeon can easily place an implant in the sclera.

Another object of the present invention is to provide an implant that can be easily inserted into the sclera through surgical procedures.

Another object of the present invention is to provide an implant having a fixation system for securing the implant in a desired position.

Another object of the present invention is to provide a method and apparatus that can be used to treat presbyopia and elevated intraocular pressure.

Another object of the present invention is to provide an implant that can be administered directly from the implant into the eye for a long time.

Hereinafter, the present invention will be described in detail with reference to the accompanying drawings.

1-6 showing preferred embodiments of the implant device 10, FIG. 1 shows the location and surgical method of placing the implant device 10 in the eye 12. FIG. Surgical implantation of the implant device 10 is to cut the sclera 16 radially to the cornea 20, the center axis 14 of the eye 12 along the line 2-2 of FIG. A radial incision is made.

The basic structure of the eye 12 is composed of an eyeball having an outer film, a middle film, and an inner film. The outer membrane consists of the sclera 16, a tough fibrous white layer, and the sclera communicates with the conjunctiva 18, the mucosa covering the eyelid endothelium and the ocular front, but the conjunctiva 18 is the central transparent portion of the outer membrane. Does not cover The middle film contains the pigment and forms the iris 22. The inner membrane is the retina 24, which is a membrane for seeing light. The lens 26 is an oval disc behind the iris 22. Two-thirds of the light entering the eye 12 is typically focused on the cornea 20 and the other 1/3 on the lens 26. Focusing of the lens is achieved by simply pulling and expanding the platoon 30 between the ciliary muscle 28 and the lens 26.

As we age, more and more people suffer from presbyopia, a vision condition in which the lens 26 loses its elasticity or the platoon 30 increases to prevent the ciliary muscle 28 from focusing the lens 26 as necessary. By implanting the implant device 10 in a surgical manner in accordance with the present invention, the recombined sclera 16 covers the device 10 and tensions the ciliary muscles 28, resulting in a longer working distance of the ciliary muscle and consequently the lens ( It is thought to improve the visual acuity of patients who have implanted the device using implantation techniques. The diameter of the lens 26 is reduced and the platoon 30 is slightly increased to increase the working range due to the tension of the sclera caused by the recombination of the sclera 16 over the inserted device 10.

Intraocular pressure in the eye (12) is caused by the fluid in the eye (12) naturally accumulated in the anterior eye (36) and the posterior eye (38) due to the flow of fibers (similar to manhole grate) to the Canal of Schlemm. Corneal venous sinus is an eye sewer that removes excess fluid and lung byproducts. Subsequent to the procedure using the method described above for implanting the device 10 into the patient's eye, it has been found that the intraocular pressure drops further when the fluid is withdrawn from the eye. As is well known, after implanting the device in the four quadrants of the eye 12, the sclera 16 is tightened to effect the tension of the ciliary muscles 28, and the lens 26 connected thereto is also drawn to draw the fluid through the trabecular column. By improving the flow, fluid can be withdrawn from the anterior eyeball 36 and the posterior eyeball 38. Of course, other descriptions will be apparent and expected to those skilled in the art, but in the current best mode the patient will experience intraocular pressure drop after implanting the device 10 with the implantation method of the present invention.

When performing a surgical method to insert the implant 10, the surgeon first starts a narrow conjunctival incision, such as the conjunctival incision 32 of FIG. 1. It is preferable to form several, preferably four, conjunctival incisions 32 between the muscles 48 connected to the outer surface of the eye 12, one for each quadrant of the eye 12. The sclera 16 is exposed through the conjunctival incision 32, and then the radial incision 34 is opened about the axis 14 of the eye passing through the center of the iris 22 inside the conjunctival incision 32. Make. It is known that the radial incision 34 is preferably about 0.5 mm from the periphery to about 3 mm in length and about 600 μm in depth. However, depending on the size of the device 10 to be implanted, the size of the cutout may be such that the device 10 can be inserted. It has been found that the radial placement of the radial incision 34 relative to the axis 14 or the radial placement of the circle forming the iris 22 is most desirable for both control of the eye 12 and drainage improvement.

Once the cutout 34 has been completed and correctly positioned in the manner described above, the implanter 10 is placed in a space consisting of the cutout 34. At this time, the incision 34 may be sutured with a suture means such as a suture 44 that pulls the sclera flap 21 on the implant device 10, and when the incision is recombined, tension is applied to the sclera 16. And communicate with the structure of the sclera 16. As will be appreciated by those skilled in the art, other means of suturing such incisions may be used, and new means continue to be developed and used. A radial space 19 is formed when recombining the scleral flaps 21 surrounding the implant device 10 located in the incision. Implanting the implant 10 radially away from the cornea 20 may also be done in other ways, such as drilling or scanning, in the future by laser or mechanical means. An important feature of the implantation device and method described above is that the implantation device 10 is located radially and positioned in the space 19 and radially positioned relative to the cornea 20 in a surgical manner.

After the incision 34 is closed, the conjunctival incision 32 is sutured by jijitsu or the like. The implantation is now complete and the implant device 10 is properly positioned to improve both vision and drainage of the patient. Implant 10 may be removed in reverse order.

Implants used in a surgical manner consist of materials that do not react when in contact with body tissue in this embodiment. Implant apparatus 10 occupies a space 19 that occurs when suture 34 is closed in the manner described above. Closing the incision 34 and suturing the scleral flap 21 or recombining with the other sclera 16 and pulling over the implant device 10 strains the sclera 16. Preferred materials are hydroxyapatite, silicone, polymethylmethacrylate, acryl, tantalum and the like. Those skilled in the art will be able to use or develop other materials.

The implant apparatus 10 includes a main body 46 and means for fixing the implant apparatus to the space 19 so as not to move. An anchor 48 protruding from the main body 46 is preferable. Other means for securing the device when installed in the space may be a serration 50 or a curved projection 52 or a hole 56 through the groove or body of the outer surface of the body 46. One or more of these means may be used to keep the implant 10 from moving.

On the other hand, if the drug is to be administered to the implantation point (many of these diseases require local dosing), the implantation device may be provided with a means for administering from the implantation device 10 to the surrounding eye tissue. Such a dosage system may be comprised of a microcapsule coating or other polymer or coating with a long dissolution time 58 outside the device, or may be placed inside the body 46 to contain medicine in solid or liquid form, and through the channel 62. It consists of a receptor 60 that supplies medicine to surrounding tissues. Alternatively, a suitable drug may be contained in the material of the implantation device 10, and the medicine may be separated over time. When using the receptor 60, it is possible to adjust the dosage and dosage time by adjusting the dosage made through the channel 62, or when using a coating, the dosage can be adjusted at the desired time by adjusting the polymer or substrate in which the drug is dissolved. have. In the case of the receptor 60, the implanter may administer a predetermined dose for a predetermined period of time and then refill the channel 62 using a hypodermic syringe 27, in which case the syringe penetrates the sclera 16 Receptor 60 is refilled via 62. Therefore, the refilling apparatus 10 can be refilled without removing or damaging the fixation state inside the space 19.

The body 46 of the implant device 10 of FIG. 6 is cylindrical, not hexahedral, as shown in FIGS. 3-5. The main body 46 functions well in any form as long as the fixing means for fixing the device 10 in the space protrudes. Although the curved protrusion 62 is visible on the outer circumferential surface, the curved protrusion may be removed on one side so that the scleral flap 21 is smoothly covered by the implantation apparatus 10 in some cases.

While the present invention has been described with reference to some embodiments, a person of ordinary skill in the art will be able to make many modifications and changes without departing from the scope of the present invention. Accordingly, all such modifications and changes should be regarded as belonging to the scope of the present invention, and the present invention is limited only to the claims.

Claims (26)

Intrascleral implants for lowering intraocular pressure and treating presbyopia: And an elongated body portion sized for implantation into a radially disposed elongated space formed in the sclera tissue of the eye. 2. The implantation apparatus of claim 1, further comprising means for immobilizing the body portion in the elongated space to prevent movement. 3. The implantable device of claim 2 wherein said means for securing said body portion to an elongated space comprises one or more pillars protruding from said body portion. 3. The implantable device of claim 2 wherein said means for securing said body portion to an elongated space comprises one or more curved protrusions protruding from said body portion. 3. The implantation apparatus of claim 2, wherein said means for securing said body portion to an elongated space comprises a serration formed on an outer surface of said body portion. 3. The implantation apparatus of claim 2 wherein said means for securing said body portion to an elongated space comprises a plurality of pillars protruding from said body portion. 3. The implantation device of claim 2 wherein said means for securing said body portion to an elongated space comprises one or more apertures formed in the side wall of said body portion. 3. The apparatus of claim 2, wherein the means for securing the body portion to an elongated space includes at least one pillar protruding from the body portion, at least one hole formed in the side wall of the body portion, at least one curved protrusion protruding from the body portion, and an outer surface of the body portion. Implantation apparatus comprising a combination of one or more selected from the group consisting of serrations formed. 2. The implantable device of claim 1, further comprising means for sending the drug remaining in the implantable device to surrounding tissue. 3. The implantable device of claim 2, further comprising means for sending the drug remaining in the implant device to surrounding tissue. 10. The implantable device of claim 8 further comprising means for sending the drug remaining in the implant device to surrounding tissue. 10. The implantable device of claim 9, wherein the means for directing the drug remaining in the implant to the surrounding tissue comprises a soluble coating coated on the implant. The method of claim 9, wherein the means for sending the drug remaining in the implant device to the surrounding tissue, An accommodation space containing the medicine while being inside the main body; And And at least one channel connecting the receiving space with tissue surrounding the implant. 11. The implantable device of claim 10, wherein the means for delivering the drug remaining in the implant to the surrounding tissue comprises a soluble coating coated on the implant. The method of claim 10, wherein the means for sending the drug remaining in the implant device to the surrounding tissue, An accommodation space containing the medicine while being inside the main body; And And at least one channel connecting the receiving space with tissue surrounding the implant. The implantation apparatus of claim 13, wherein the accommodation space is refillable without detaching the implantation device from the elongated space. The implantation apparatus of claim 15, wherein the accommodation space is refillable without detaching the implantation device from the elongated space. In the method of lowering intraocular pressure: Radially placing one or more elongated implants in space within the sclera. In treating presbyopia: Radially placing one or more elongated implants in space within the sclera. In the method of lowering intraocular pressure: Radially placing a plurality of elongated implants in a plurality of spaces in the sclera. In treating presbyopia: Radially placing a plurality of elongated implants in a plurality of spaces in the sclera. 19. The apparatus of claim 18, wherein the implant device Elongated body; And And means for immobilizing the main body in an elongated space so as not to move. The device of claim 20, wherein the implant device is Elongated body; And And means for immobilizing the main body in an elongated space so as not to move. 23. The method of claim 22, wherein the implant further comprises means for sending the drug remaining in the implant to peripheral tissue. 24. The method of claim 23, wherein the implant further comprises means for sending the drug remaining in the implant to peripheral tissue. In surgically implanted implants to lower intraocular pressure or treat presbyopia: Making a small incision in the conjunctiva to expose the sclera; Radially dissecting the sclera to form a scleral flap; Disposing an elongated implant in a space formed in the radially incision; Suturing the scleral flap over the elongated implantation device to form a space surrounding the implantation device.