KR20020063003A - Systems and methods for reducing intraocular pressure - Google Patents

Abstract

The present invention provides systems and methods for reducing intraocular pressure for treating glaucoma and other diseases. The system of the present invention includes a shunt 10 that can be inserted across the transparent cornea 104 and an extraction device 200 for inserting the shunt in the position of the cornea. The shunt has a head 12 at one end and a body with a foot 18 at the opposite end, and a through channel 24 that allows passage of intraocular water from the anterior 108 to the outer surface of the cornea. A removable filter 28 is disposed inside the channel to regulate the outflow of home water and prevent the invasion of microorganisms.

Description

System and method for reducing intraocular pressure {SYSTEMS AND METHODS FOR REDUCING INTRAOCULAR PRESSURE}

The eyeball is a substantially spherical structure having a tone and shape held by the endogenous fluid material filling the outer hollow glue sphere. The inside of the eyeball is divided into two chambers, anterior and posterior. Between the rooms hang the lens and its support and associated tissues. The back chamber is filled with a gelatinous substance called vitreous fluid, which is not thought to significantly affect the intraocular pressure level called intraocular pressure (IOP). The front side, on the other hand, is filled with dilute fluid called constant water that is constantly produced and reabsorbed. The fluid exerts pressure on the upper cornea and all the structures surrounding it. If the amount of produced intraocular water is excessive, the pressure in the anterior and intraocular eye will rise. Normal IOPs are due to a healthy equilibrium between the production and reabsorption of intraocular water.

Axial water is produced behind the base of the iris and flows inward. Resorption occurs through a trabecular meshwork system, from which the fluid passes into the scleral vessels that are absorbed into the bloodstream. The front constant pressure range is generally considered to be 10 to 21 mmHg. The pressure in the front chamber is determined by how quickly the water is produced and how quickly the water is discharged through the residue round system. Failure of the discharge system can cause an increase in intraocular pressure. Sustained elevations of IOP develop a condition known as glaucoma, which is eventually blind if the elevated IOP damages the optic nerve and adversely affects vision, if not treated properly.

Various therapies for glaucoma can be used. Medical therapy seeks to reduce IOPs that promote the outflow of fluids or reduce the production of fluids. Medical treatments available may include topical or tissue dosing. However, medical treatment may fail due to low compliance, high cost, or any of a number of well-known complications or side effects of the patient. If the medical treatment is unsuccessful, a more invasive treatment may be proposed that alters the reference anatomy or introduces an implantable ejection device to alleviate excessive intraocular water. For example, laser surgery may be recommended to alter the anatomy of the residue round to improve anterior ejection; Other laser-included ophthalmic procedures can be used for the treatment of glaucoma. Glaucoma eyes that continue to have elevated intraocular pressure despite medical intervention and laser intervention may require constant surgical intervention.

As one example, conventional forms of surgical methods aim at generating a fistula or other exit channel from the front of the eye. Thus, intraocular water is oriented to flow into the pockets of the sclera or the sclera generated surgically, often referred to as the "bleb," from which fluid can be reabsorbed into the bloodstream. This surgical procedure reduces intraocular pressure by causing excess fluid to flow outward. However, such treatments involve a number of known limitations. First, since normal wound treatment tends to interfere with the opening of the fistula and the size of the drainage pocket, such surgical treatment may have an unacceptable failure rate. To increase the success rate of such types of surgical procedures, doctors recommend adjuvant therapy that modulates normal wound treatment with medication. Such therapies increase the incidence of the second type of problem associated with such treatment: excessive or upward shedding of stable water. Rapid removal of excessive amounts of stable water can cause intraocular pressure to drop to dangerously low levels called hypotony, which potentially leads to a number of very threatening complications. To prevent such a problem, the surgeon must be treated well enough to produce controlled intraocular discharge. For that to happen, normal wound treatment is essential. Therefore, such treatments that interfere with wound healing increase the risk associated with excessive release of drained water. A third class of problems involves the usual release procedures of the type described above: increased risk of infection. Discharge of the intravenous water into the blisters under the sclera or conjunctiva poses a risk for infection by providing a fluid environment into which microorganisms can invade. Moreover, when an infection occurs in a fluid-filled pocket, the microorganisms can move backwards through the discharge channel, entering the front of the eye and infecting it so that it is in a very serious condition.

In order to address the problems associated with conventional surgical procedures, a number of implantable devices have been proposed for discharging excess fluid from the front. However, the above-mentioned problems, which adversely affect the surgical treatment of soft tissues, also adversely affect implantation surgery. Such surgery involves the installation of intraocular implants, but wound healing mechanisms are still used. In addition, the artificial material excessively stimulates local wound healing, resulting in excessive scar tissue formation. Moreover, even if artificial processes are involved in such a process, control of the rate of discharge of aquatic water remains an essential problem. There is also the problem of infection. For mechanical conduits available for delivering microorganisms from the outside to the inside of the eye, a mechanism for inhibiting retrograde infection is desirable. Finally, the eye, like most tissues of the body, has limited tolerance to the long-term reality of artificial materials. Locally placed implants can cause inflammation of surrounding tissue. Of course, the eyes are particularly sensitive. The device to be implanted on the surface of the eye can be felt chronically, persistent, and bothersome by the patient. Finally, since the eye tissue is very sophisticated, the implant must be designed and placed so as not to damage the weak adjacent, lower or upper tissue. Even if properly placed initially, the implant can be displaced by local tissue movement or pushed out by a contractile wound healing process.

Various devices of the prior art are intended to provide a solution to some or all of these problems. For example, certain prior art devices avoid intraocular water into a vessel or drainage area implanted under the sclera or subconjunctiva. However, as mentioned above, such devices face the problem of regulating intraocular fluid leakage, preventing infection, and avoiding local tissue inflammation and trauma. The first problem of having to control the drainage of the fluid is that the rate of discharge of the fluid depends substantially on the mechanical properties of the implant until there is sufficient wound treatment to biologically limit fluid outflow. An effective balance of biological and mechanical resistance to outflow water has problems with implant-based discharge processes. Prior art devices utilize various mechanisms for limiting the release of intraocular water. However, each such mechanism is reliable once the wound has been healed. Restricted components in the implant, when combined with the limitations caused by wound healing, can excessively reduce the rate of release of bleeding water to an untreated level. A second problem, the possibility of intraocular infections, arises from the presence of an implant that provides a conduit, through which the bacteria can secure passage to the inside of the anterior chamber. Certain prior art devices have introduced filters, valves or other conduit systems to prevent retrograde transmission of infection in the forefront. However, such mechanisms also have limitations: even if they are effective to prevent the passage of microorganisms, they also have a hydraulic effect on fluid outflow that can damage the effective outflow. Finally, the problem of local tissue resistance is that in certain prior art devices, such foreign bodies can promote tissue reactions that lead to local inflammation or extrusion, and that such foreign bodies can be more perceived or uncomfortable by the patient. Occurs: The response to the implant may make the use of the implant clinically inadequate.

Devices placed through the transparent cornea to drain the intraocular water are intended to circumvent certain limitations involving the sclera or subconjunctival implantation. For example, the devices of U.S. Patent Nos. 3,788,327, 5,807,302, and 5,743,868 provide transcorneal conduits that flow anterior fluid onto the surface of the cornea to mix with the tear film. The devices disclosed in this patent include certain features regarding the problems of runoff control, microbial restriction, local tissue compatibility and location stability. Such problems mentioned above still adversely affect the corneal device. Therefore, there is a need for a biocompatible anterior ejection device that allows for a well controlled outflow of intraocular water despite the transformation of wound treatment. There is also a need for a discharge device that can protect the interior of the eye from infection by limiting the entry of microorganisms. Moreover, there is a need for a patient resistant and comfortable ophthalmic ejection device. Finally, the problem of positional stability has not been satisfactorily solved yet. There is a need in the art for an exhaust device that can be reliably and reliably deployed without the worry of removal, movement or extrusion.

In addition to the above mentioned need for permanent or durable discharge of a disease such as glaucoma, there is an additional need for temporary anterior discharge or decompression. For example, an increase in IOP over a short period of time (1 hour-2 weeks) may occur after a number of ophthalmic procedures, including cataract extraction and correction of retinal detachment. Moreover, doctors know that it is advantageous to use shunts to control the transient IOP of glaucoma before embarking on other surgical procedures for diseases that do not use prolonged shunting. In this situation, there is a need for a device that can meet the demand for long-term forward emissions.

There is a need to provide an extraction system that is particularly suitable for atraumatic insertion of the corneal drainage device. It is advantageous for such extraction systems to securely hold the discharge device so that it can be placed by the physician. Such extraction system will allow for quick release of the discharge device when it is inserted through the cornea. The extraction system is preferably designed to avoid additional damage to the corneal epithelium and the delicate tissue of the matrix.

This application is related to and claims US Provisional Patent Application No. 60 / 175.658, "Glaucoma Pressure Relief Valve and Drug Delivery Device," filed Jan. 12, 2000, the contents of which are incorporated herein by reference. do.

The present invention relates to systems and methods for reducing intraocular pressure. In one embodiment, the present invention relates to an implantable device for draining intraocular water to alleviate the high intraocular pressure characteristics of glaucoma.

1 is a perspective view of one embodiment of the present invention.

2 is an exploded view of one embodiment of the present invention showing the insertion path of a filter.

3 is a cross-sectional view of one embodiment of the present invention.

Figure 4 is an anatomical cross-sectional view showing a shunt according to the present invention.

5 is a schematic diagram of one embodiment of the present invention.

6A to 6D are perspective and cross-sectional views of the extraction apparatus according to the present invention.

7A to 7B are perspective and cross-sectional views of a modified embodiment of the extraction apparatus according to the present invention.

It is an object of the present invention to provide a system for reducing intraocular pressure. The system according to the invention comprises a shunt which is inserted into the anterior chamber through the clear cornea of the eye and can drain the aqueous solution therefrom. The shunt comprises a substantially cylindrical body having a through channel that permits the release of intraocular water from the anterior to the outer surface of the clear cornea; The shunt is a head disposed with respect to the outer surface of the transparent cornea, a foot disposed with respect to the inner surface of the cornea, and an elongated filter held in the channel of the body to regulate the flow rate of intraocular water through it and minimize the entry of microorganisms. It further includes. In one embodiment, the backwater flows through a hole in the foot, enters a channel in the body, passes through it, exits through a slit in the head, and flows onto the surface of the cornea. In one embodiment, the head and the foot are integrally formed with the body. In other embodiments, the head, foot or body may be made of dehydrated polymer. In certain embodiments, the outer surface of the head or foot can be shaped to minimize cell adhesion or adhesion. In certain embodiments, the outer surface of the body may be formed to facilitate adhesion or attachment of tissue, or to have an attractive force. The foot may be specially formed to facilitate the introduction of a shunt through the cornea. In certain embodiments, the body is smaller in circumference than the head or foot. The elongated filter can be retained in the channel of the body by an action or other suitable mechanism. The elongated filter may be disposed at the proximal end of the body or at another location.

In another embodiment, the system according to the present invention comprises an implant that can be positioned across the cornea to eject from the front of the eye. The implant is a head, a foot, a tubular conduit having an inner channel disposed between the foot and the head and in fluid communication with the front, and tightly in the front, to control the outflow of stable water and to restrict or invade microbial invasion. Filter to minimize or block the passage of microorganisms.

In yet another embodiment, the system according to the invention may comprise a corneal shunt and may further comprise an extraction device for implanting the shunt at the corneal position. In a particular embodiment, the corneal shunt, which is implanted with the extraction device, is disposed within the head, the foot, a substantially cylindrical body disposed between the head and the foot and having a through channel, and through the channel. A filter is included to control the flow rate of the backwater and to limit the entry of microorganisms. In a particular embodiment, the extraction device includes a tip sized to hold the shunt and to position the shunt for insertion through the outer surface of the cornea and also slidable from a proximal position to a distant position. It further comprises, the sliding of the plunger removes the shunt, forcing it through the outer surface of the cornea to the corneal position.

Another object of the present invention is to provide a method of treating glaucoma and other diseases characterized by elevated anterior pressure, by reducing anterior fluid pressure. The method includes the steps of providing a corneal shunt, providing an extraction device for placing the shunt at the location of the cornea, and cutting a pilot hole through the outer surface of the cornea to allow insertion of the shunt. And using the extraction device to insert the shunt into the keratinous position. In one embodiment of the present invention, the provided shunt may have a substantially cylindrical body, head, foot and filter. Another object of the present invention is to provide a method for reducing intraocular pressure by temporarily discharging the front fluid. Transient emissions are those that occur over a short period of time, for example, from one hour to several weeks, using a device that can be removed at the end of the temporary discharge period or can be biodegradable to be resorbed at the end of the temporary period. I understand. Such a device is useful for transplantation according to the above procedure, which may be followed by an increase in IOP, or as a temporary correction for a disease characterized by increased IOP.

The shunt according to the invention is intended to solve the above mentioned problems which persist in the field of ophthalmology for the treatment of increased IOP. First, the shunt, its extraction device, and method for their use are suitable for avoiding the difficulties associated with evacuation of the subconjunctival or subsclera by placing the evacuation system in the transparent cornea. Second, predictable runoff rates can be calculated so that the outflow of backwater is consistently controlled by the filtration system without affecting the mechanism of wound healing, thereby avoiding the risk of hypotonia on the one hand and the risk of improper discharge on the other hand. Can be. Third, the filter provides a twisted pathway to prevent the entry of bacteria; In addition, the slit opening of the head is shaped and sized to resist the invasion of bacteria; Moreover, the head itself is made of a material that prevents adhesion between cells, including the attachment of microorganisms. Fourth, the device is made of a material having good resistance to the cornea. The head and foot prevent intercellular adhesion and block scars throughout the device, but the body is made of a material that promotes intercellular adhesion, thereby making it possible to reliably add the device to the location of the cornea. Various objects, features and advantages of the present invention will become more apparent with reference to the drawings, denoted by like numerals in the same components as the description below.

1 shows a perspective view of a shunt 10 according to the invention. In an exemplary embodiment, the shunt 10 may be about 1 mm long with an outer diameter of about 0.5 mm. Although the shunt 10 is shown as a cylindrical structure in Figures 1 and below, it is understood that it is appropriate for the contour of the tubular conduit. For example, the shunt 10 can take a more elliptical shape or a more convex shape. 1 shows the shunt 10 from its top or outside. The shunt 10 is sized appropriately for placement of the cornea. The head 12 will be placed on the outer surface or epithelial surface of the cornea when the shunt 10 is placed in place. As shown in FIG. 1, the head 12 can be dome-shaped to provide a continuous transition surface from the device to the cornea. This shape also allows it to be well tolerated by the patient's eyelids. While this shape seems particularly advantageous, other shaped heads can be designed to provide the same advantages. For example, the least protruding flat head 12 with rounded edges can equally well tolerate. Other suitable designs can be determined using routine experimentation. The lower surface (not shown) of the head 12 may be flattened or curved to suitably match the shape of the corneal surface on which the device is to be placed. The head 12, the main body 14, and the foot 18 may all be integrally formed as one unit, or the head 12 or the foot 18 may be integrally formed with the main body. In other embodiments, each component may be exploded from other components.

Copolymers of hydroxyethyl methacrylate (HEMA) can be used to make components of the shunt. In one embodiment, the head 12 is formed of a flexible material to prevent adhesion of tissue and bacteria and is highly hydrated and prone to tears. Head 12 may have a surface component comprising a HEMA polymer, such as HEMA plus methacrylic acid, well known in the art to prevent cell adhesion. As one example, poly2-hydroxyethyl methacrylate (PHEMA) can be used for the shunt casing. In one embodiment, the base material for the tissue complete layer coating that attracts the cells may include HEMA and cyclohexyl methacrylate. Covalently crosslinked hydrogels, used in contact lenses and having an equilibrium moisture content of at least 15% by weight (more preferably at least 20% by weight), are especially esters of dihydroxy and polyhydroxy compounds with acrylic acid and methacrylic acid. It may be included in the components of the casing, such as a copolymer of. Examples of suitable polyhydroxy compounds include ethylene glycol, diethylene glycol, triethylene glycol, 1,2-propanediol, glycerol, glycerol monoacetate, glucose and the like. Such esters may be copolymerized with vinylpyrrolidone, acrylic acid, methacrylic acid, acrylamide, N-substituted acrylamide, and many other similar components, as will be apparent to those skilled in the art. Dozens of specific components, such as hydrogels, are known in the art and many of them can be readily and readily identified to those skilled in the art through routine experimentation. Representative crosslinkers are diacrylates and dimethacrylates of the diols and polyols. In certain embodiments, the surface of the body 14 may comprise a layer of tissue components comprising a crosslinked polymer, such as, for example, components comprising HEMA and alkyl methacrylates, in particular cyclohexyl methacrylate. In this phase the alkyl methacrylate is used at a higher concentration than HEMA. The tissue component layer can be smoothed, patterned or porous. In one exemplary embodiment, the shunt of the present invention comprises a local surface region with reversible hydration, shape memory, hydrophilicity or hydrophobicity, a local surface with different hydration, and a local surface with different intercellular adhesion. It is characterized by certain physical properties.

Bacterial invasion is further prevented by the slit 22 across the head 12. The slit 22 flows through the shunt to the transparent cornea, thereby allowing the outflow of the aqueous solution entering the tear film. Although the slit 22 shown in FIG. 1 is an elongated single hole, it will be appreciated that other shapes of slits are also available that favor the prevention of outflow of bacteria and invasion of bacteria. For example, multiple small slits can be designed in one pattern. Or, for example, one slit or series of slits may be formed shorter and more curved than shown in FIG. Other slit shapes can be readily designed by those skilled in the art.

The foot 18 may be made of a material similar to the head 12. 1 shows the top or outer surface of a foot 18 suitable for contact with the inner or endothelial surface of the cornea. As shown, the foot 18 may be flattened or curved to suit the shape of the corneal surface that it contacts. The foot 18 can also be tapered or conical to facilitate its insertion through the cornea. In the illustrated embodiment, the foot 18 is wider than the body 14. The inner surface (not shown) of the foot 18 has a hole, through which the inner water enters the shunt 10. These and other characteristics of the foot 18 will be presented in other figures.

Referring further to FIG. 1, the body 14 of the shunt 10 is disposed between and connected to the head 12 and the foot 18. The body 18 may be made of a solid HEMA polymer and coated with a hydrogel, such as a copolymer of HEMA and cyclohexyl methacrylate, which acts to promote intercellular adhesion. Since the coating 20 of the body 18 is sensitive to tissue adhesion, the body 18 can be securely fixed in place. Such characteristics allow the shunt 10 to resist movement and displacement in situ. In addition, such properties serve to prevent bacterial ingrowth along the corneal channel where the shunt 10 is placed. To further promote tissue ingrowth and intercellular adhesion, the coating 20 of the body 18 may be surface modulated, such as texturing, roughening, or the introduction of patterned irregularities. . The combination of the HEMA polymer that prevents intercellular adhesion on the head 12 and the foot 18 and the HEMA polymer that promotes intercellular adhesion on the body 14 allows the shunt 10 to penetrate the cornea through which the body 14 penetrates. And firmly attach, and also allow the shunt 10 to resist bacterial attachment to the head 12 with potential subsequent intrusion.

It will be appreciated that devices made with HEMA are well adapted by the eye. In addition, devices made of dehydrated polymers, such as HEMA, can be dehydrated to be reduced to smaller sizes for implantation through small incisions. Such properties can facilitate the insertion of shunts through guide holes or similar small access routes with minimal tissue disruption. After the dehydrated shunt 10 according to the invention is properly placed, it can absorb moisture from the surrounding tissue and expand to its predetermined size. Depending on the particular hydrogel formulation, the degree of dehydration can be varied. Even if dehydration reduces the size a bit, it can facilitate the transplant. Moreover, implanting the dehydrated device at its location of the cornea, so that it absorbs and enlarges the moisture, will allow the device to fit securely in the desired location.

2 is a perspective view of the shunt 10 showing the bottom or the inside. In the illustrated embodiment, when the shunt 10 is anatomically placed, the foot 18 is placed in the inner or endothelial cellworm of the cornea and protrudes inward. In this figure, the body 14 and the head 12 are also shown. The shunt 10 has a channel 24 formed through the foot 18 and the body 14 to approach the bottom of the head. As illustrated in FIG. 1, a slit (not shown) on the head 12 allows for the discharge of the backwater flowing through the channel 24. The filter 28 regulates the flow of the aqueous water from the front to the outside of the eye and provides a twisted path through the channel 24 to block the passage of bacteria. In one embodiment, filter 28 may be made of titanium. Other materials such as ceramics and polymers may also be used for the manufacture of the filter 28. In certain embodiments, filter 28 may be in close contact with channel 24 of body 14. Filter 28 may be intended to form a permanent element of shunt 10. Optionally, filter 28 may be removed and replaceable in embodiments in which a passage to channel 24 is provided without destroying the corneal membrane position of shunt 10. For example, the removable head 12 allows access to the filter 28 so that it can be removed and replaced. As another example, the head 12 may have an access port (not shown) arranged such that a passage to the filter 28 is available without changing the position of the head 12. In certain embodiments, the attachment to the access port and its head 12 may be integral with the slit system described above. Other arrangements can be readily envisioned by those skilled in the art. The filter can be housed in a rigid housing. The housing can be inserted into the shunt body 14 and also removed from the shunt body 14 after the tissue completion layer is attached in place with the body 14, without interfering with the attachment of the casing in the eye.

As shown in Fig. 2, the filter 28 may be manufactured as a cylinder and inserted into the channel 24 by indentation. In the embodiment shown, the channel 24 has a flexible wall 30. A filter 28, typically of size about 0.02 × 0.02 inches, is securely fixed in contact with the wall of the channel 24. The illustrated filter 28 includes a network of holes having a pore size of about 0.5 micron. The size of the aperture makes it suitable for controlling the flow rate of the fluid at about 2 microliters per minute. The flow rate obtained by making the size of the hole and the length of the flow path to provide adequate resistance to flow is sufficient to prevent eye strain, while reducing excessive intraocular pressure associated with glaucoma. While the pore sizes and flow path lengths of the types described above appear particularly advantageous for the system of the present invention, it will be appreciated that other types of pore sizes and flow path lengths may also be appropriate. In addition, the hydraulic characteristics of metals, ceramics or polymers may vary, and specifications for filters made of such materials may vary, but are beyond the scope of the present invention, and the purpose of the filter is to maintain consistent consistency It is to be understood that it provides a predictable, predictive, pathophysiologically desirable runoff rate, but which interferes with the retrograde pathway of the microorganism.

3 is a cross-sectional view showing a shunt 10 according to the present invention. This figure shows the flow path of the backwater discharged from the front through the channel 24 through the body 14 and through the slit 22 of the head 12. This figure shows the head 12, the body 14 and the foot 18, all manufactured integrally as one unit. This figure also shows a single linear slit 22 through the head 12. The slit 22 shown extends axially through the head 12. Other types of slits can also be envisioned. For example, irregular slit paths may be provided. Multiple slits or combinations of slits and other shaped holes may also be provided. In this figure, a coating 20 having an irregular surface is applied to the outside of the body 14. Filter 28 is shown to be securely placed within channel 24. As shown in this figure, filter 28 occupies the center portion of channel 24. Other positions of the filter 28 are also possible. For example, filter 28 may be disposed above or below what is shown.

4 shows an anatomical cross section of the shunt 10 at an anatomical position across the cornea 104. As mentioned above, the surfaces of the illustrated embodiments are made of other materials having other properties, such as surfaces that are resistant to intercellular adhesion or protein deposition, and surfaces that are attractive to intercellular adhesion as described above. Can be. The head 12 of the device is disposed on the corneal surface 118. The shunt 10 has a through passage that allows fluid in the front 108 to flow across the transparent cornea 104 to the outer surface of the eye. Fluid entering the medial passageway of the shunt 10 will exit the device and flow onto the outer corneal surface 118 where it mixes with the tear film. This figure shows the head 12 of the shunt 10 in contact with the outer corneal surface 118. This figure also shows the foot 18 in contact with the medial corneal surface 122, but such contact is not necessary for satisfactory placement. In a typical arrangement, the shunt 10 of the present invention is placed above the transparent cornea and covered by the upper eyelid during neutral gaze. Embodiments of the shunt 10 in accordance with the present invention may be formed to span the corneal matrix between the tear film on the outer corneal surface 118 and the anterior 108. In a particular embodiment, the shunt 10 includes at least the components described below: (a) a body 14 made of a hydrogel and having an outer surface in direct contact with the matrix tissue; (b) a head 12 protruding from the cornea and having an outer surface in contact with the tear film and at least intermittently in contact with the inside of the eyelid (not shown); (c) Foot 18 protruding into front 108. In the disclosed embodiment, the outer surfaces of the body 14 and the head 12 have other characteristics, at least in terms of intercellular adhesion and water wettability. In a particularly suitable embodiment, the outer surface of the head 12 is non-adherent to the cells, wet to tears, highly hydrated, while the outer surface of the body 14 is low hydrated. , Has high adhesion to cells. 4 also schematically shows another anatomical structure. The lens 100 is shown to separate the anterior 108 from the posterior 102. The ciliary protrusion 114 of the ciliary body 112 is located at the side of the lens 100, and such a structure causes the generation of intraocular water. There is an iris 120 in front of the lens 100.

5 schematically shows one embodiment of a shunt 10 according to the invention. In the illustrated embodiment, the body 14 is penetrated by a channel 24 with a diameter of about 0.017 to 0.018 inches. In the illustrated embodiment, the channel 24 is about 0.048 inches long. Filter 28 is presented in channel 24. Filter 28 has a vertical height of about 0.020 inches. The filter is advantageously formed to receive microorganisms such as bacteria, viruses, fungal species and their spores. The foot 18 is shown with a tapered edge 16 to facilitate insertion through the cornea of the shunt 10. The tapered edge 16 shown in the figure is inclined at an angle of 45 degrees over a distance of about 0.008 inches. Foot 18 has an overall vertical height of about 0.013 inches. Other sizes and shapes of the foot 18 can be envisioned to facilitate insertion through the cornea of the shunt 10, but to allow the foot 18 to be properly positioned and retained in the front. For example, the foot 18 can have a folded or flat structure, which minimizes its size due to dehydration and expands to a larger size due to rehydration. In other embodiments, the foot 18 may have a conical or inverted cone shape that can be folded to facilitate its insertion. In certain embodiments, the foot 18 is larger than the body 14 as shown in the figure. The filter 28 shown in the figure is arranged at the top of the channel 24, but other positions of the filter 28 are consistent with the present invention. For example, filter 28 may be disposed more roughly in channel 24, or it may occupy a close contact with the channel, or it may be that filter 28 occupies substantially the entirety of channel 24. It can be made to have sufficient flow path length and hole size to:

In a particular embodiment, the shunt 10 according to the present invention is formed of a shape memory polymer that can be converted into a suitable deformed shape for insertion through a small incision, thereby providing a preselected shape depending on the hydration or the temperature of the body. Can be returned. For example, a shunt 10 that is partially dehydrated at a softening temperature (T _s ) that is higher than room temperature and preferably close to body temperature may have an access incision (eg, slit, ablation, perforation or other approach familiar to those skilled in the art). May be initially inserted through the incision into the corneal position and then expanded to take its preselected size and shape upon rehydration and temperature increase.

The method of making a shunt according to the present invention includes making in a mold or disposable by disposing the tissue complete layer as a curable component. For example, a corneal implant or shunt may be cast into a mixture of HEMA, methacrylic acid, dimethacrylate crosslinker, and free radical initiator in a single part silicone mold having a cavity formed by printing into a die molded into a preselected shape. Can be. Optionally, after the corneal implant or shunt has been machined, a tissue complete layer may be applied to the outer surface of the shunt. The tissue complete layer is a curable component comprising a copolymer of alkyl methacrylate and HEMA, a monomer HEMA, a dimethacrylate crosslinker, a free radical initiator and a volatile solvent. Other methods for making corneal implants or shunts according to the systems and methods can be readily implemented by those skilled in the art.

The systems and methods of the present invention hold a shunt or other discharge device, place the shunt or discharge device in a preselected position adjacent to the cornea, and traverse the cornea surface to occupy the corneal position. Extraction devices suitable for insertion can be advantageously used. In a particular embodiment, the extraction device includes an insertion tip suitable for releasably holding the shunt and for placing the shunt for insertion through the outer surface of the cornea, the slide being slidable from an adjacent position to a distant position. It further includes an inserter, wherein when the inserter slides from a near position to a distant position, the shunt is removed from the insertion tip, which is forced through the outer surface of the cornea to the corneal position. Guide holes or other small access wounds may be formed on the corneal surface, or, if the extraction system is used to extract the device to a preselected carotid corneal position, the induction prior to inserting the shunt or discharge device to reduce resistance Holes or other small access wounds may extend into or through the corneal stroma. In a particular embodiment, the extraction device according to the invention is suitable for instructing the operator so that the shunt is properly positioned.

6A shows an extraction device 200 suitable for inserting a shunt into the corneal position according to the present invention. The extraction device 200 shown in this figure is ergonomic with an elongated shaft 206 of the base, a gripping area 210, an inserter comprising a slidable tip portion 212, and an insertion tip 214. Have a design The shaft 206 and the gripping area 210 are formed from the body housing 202, which is preferably made of lightweight plastic material. The front portion of the extraction device 200 includes a hollow end housing 226 in which the slidable tip portion 212 can be moved forward and backward. The gripping area 210 is formed with a protruding portion 204 of the base and a protruding portion 208 of the distal end, between which the extraction device 200 is gripped with a pencil grip, whereby the shaft 206 is the operator's first rear web. To be placed in the space. The pencil grip is particularly suitable for guiding the insertion tip 214 accurately, although other types of grips may be used for the device 200 at the operator's choice. At the distal end of the insertion tip 214 is an insertion hole 218 and a shunt (not shown) can be disposed therein.

6B is a cross-sectional view of the distal end of the extraction device 200 according to the present invention with the slidable tip portion 212 advanced forward. The slidable tip portion 212 slides coaxially along a fixed plunger 220. 6B shows the tip portion 212 slidable to the forward position with respect to the fixed position of the plunger 220 within the housing 226 of the base. In this position, a chamber is formed between the distal end 230 of the plunger and the insertion hole 218 in the insertion tip 214, the insertion tip being sized to hold the shunt 10 releasably. In this figure, the shunt 10 is shown to be disposed just inside the insertion hole 218 inside the insertion tip 214 of the slidable tip portion 212. In this figure, the insertion tip 214 of the distal end of the tip portion 212 is shown in contact with the surface of the cornea 228. By doing so, the front face of the shunt 10 is disposed on approximately the same face as the distal insertion tip 214, and the rear face of the shunt 10 abuts against the distal end 230 of the plunger 220. In this position, a rear chamber 222 is also formed at the rear of the rear end 228 of the slidable tip portion 212 and in front of the fixed backstop 224. This rear chamber 222 provides a space into which the slidable tip portion 212 can be pushed by a force toward the rear. Such rearward force may occur against the slidable tip portion 212 when the operator advances the extraction device unit 200 forward with the distal insertion tip 214 in contact with the surface 228 of the cornea. have. The surface 228 of the cornea prevents forward movement of the distal insertion tip 214 and forces the slidable tip portion 212 to the rear. In contrast, the position of the plunger 220 is fixed in the extraction device 200. Therefore, as the slidable tip portion 212 is forced to the rear relatively, the plunger 220 is pushed forward relatively by the continued advancement of the extraction device 200 in the hand of the operator. As the shunt 10 and the plunger 220 in contact with the distal end 230 of the plunger 220 continue to move forward, the shunt is forced past its surface 228 to its hard corneal position. The passage of the shunt 10 through the surface 228 of the cornea can be formed by providing a small insertion site or guide hole through which the foot of the shunt (not shown) can enter. The axial length of the slide chamber 222 may be approximately equal to the length of the shunt 10. This design can mitigate the shunt 10 being pushed too far into the eye.

The degree of displacement towards the rear of the slidable tip portion 212 is shown in FIG. 6C. In this figure, the insertion tip 214 is shown at the distal end of the distal housing 226, and the slidable tip portion 212 is pushed adjacently into the distal housing 226. This figure also shows the distal end 230 of the plunger visible through the insertion hole 218 of the distal insertion tip 214, which distal end 230 of the plunger has a slidable tip portion 212 rearward. When fully pushed, it is shown that it is disposed in approximately the same plane as the distal end of insertion tip 214.

6D is a cross-sectional view showing the location of the extraction device structure as the shunt 10 is pushed through the corneal surface to occupy its corneal location across the corneal matrix 232. The slidable tip portion 212 is in its fully rearward position, and its rear end 228 abuts the backstop 224 of the plunger. The plunger 220 itself does not move in the distal housing 226. Instead, the forward advancement of the extraction device 200 pushes the tip portion 212 slidably backward with respect to the plunger 220. The shunt 10 still in contact with the distal end 230 of the plunger is forced through the corneal surface 228, advantageously through the guide hole, or the incision or insertion site, to occupy its corneal position. As the distal insertion tip 214 of the slidable tip portion 212 that no longer moves is pressed against the corneal surface 228, further application of forward forward pressure on the extraction device 200 is inhibited. At this time, the operator should not apply any more pressure.

Other mechanisms can be envisioned to inform the operator that the shunt 10 is correctly positioned. For example, the rear chamber 222 may be equipped with a notch or tab (not shown) that abuts a correlating structure on the slidable tip portion 212 when the slidable tip portion 212 is fully displaced rearward. Can be. This interengagement between adjacent structures generates an audible or tactile perceptual click that informs the operator that complete back movement of the slidable tip portion 212 and full back placement of the shunt 10 have been made. The engagement of such adjacent structures may be permanent so that the slidable tip portion cannot be returned to its forward position, or the engagement may be releasable by mechanisms such as latches, buttons, and the like. Other comparable structures for signaling the operator with respect to the position of the shunt can be readily envisioned by those skilled in the art. In certain embodiments, the entire slidable tip portion 212 or insertion tip 214 may be made of a transparent material, while the plunger may be made of an opaque or brightly colored material. This arrangement allows the operator to easily determine the relative positions of the structures. Optionally, the structures at all ends are made of a transparent material, allowing the operator to easily see the corneal surface through the transparent area of the extraction device 200.

7A shows another embodiment of an extraction device 200 according to the present invention. The contour of this embodiment is similar to the contour of the extraction device shown in FIGS. 6A-6D, for example, the body housing 202 extending rearward to form a shaft (not shown) and the protrusion 204 of the base. And distal protrusions 208 are ergonomically formed. In the illustrated embodiment, an insertion hole 218 is provided at the distal end of the insertion tip 214 through which a shunt (not shown) is releasably inserted. However, in the illustrated embodiment, the fixed tip portion 244 and the insertion tip 214 are fixed relative to the extraction device 200. A trigger 240 is provided adjacent to the gripping area 210. Trigger 240 is slidably disposed in cutout notch 242 through distal housing 226. The trigger notch 242 enables forward movement of the trigger 240 relative to the distal housing 226. As shown in this figure, even if any other convenient location for trigger mechanism 240 is selected, the trigger will be adjacent to gripping area 210. The trigger 240 can have a roughened, corrugated or irregular surface so that it can be manipulated further by the operator.

FIG. 7B shows a longitudinal cross-sectional view of extraction device 200 taken along line A-A 'in FIG. 7A. Here, the body housing 202 is presented hollow, but the body housing 202 adjacent to the trigger shaft 250 is solid or formed in another convenient manner. However, the distal housing 226 is sufficiently hollow to allow axial through motion of the slidable plunger 248. In the illustrated embodiment, the distal housing 226 also has a cutout trigger notch 242 with the trigger shaft 250 advanced therein. As shown in this figure, the forward movement of the trigger shaft 250 also forces the slidable plunger 248 forward with respect to the position of the distal housing 226. This figure shows the chamber 216 present in the insertion tip 214 of the fixed tip portion 224. The chamber 216 is sized to releasably hold a shunt (not shown) according to the present invention. When the extraction device 200 shown in this figure is used for insertion and placement of the shunt, the operator advances the trigger 240 to the foremost position of the trigger notch 242, and the trigger shaft 250 and its attachment. By advancing the slidable plunger 248, the slidable plunger 248 advances into the chamber 216 and displaces a shunt (not shown) therefrom. The insertion tip 214 of the extraction device 200 is suitable for contact with the corneal outer surface during extraction of the shunt. The operator firmly grasps the extraction device 200, causing its insertion tip 214 to contact the corneal surface at a preselected position, and the operator simultaneously advances the trigger 240 forward to designate the shunt through the cornea. Insert in As described above, various materials may be used for the manufacture of the extraction device 200. In particular, the terminal elements of the extraction device can be made of a transparent material. The slidable plunger 248 may also be made of a transparent material to facilitate viewing of the shunt. Optionally, the insertion tip 214 and / or fixed tip portion 244 can be made of a transparent material, but the slidable plunger 248 can be brightly colored so that its relative position can be easily seen. It is made of an opaque material.

By referring to the drawings described above, it is possible to understand certain methods for reducing the front fluid pressure according to the invention. In the practice of the present invention, a shunt is provided for discharging the backwater, and an extraction device is provided for properly inserting the shunt. The shunt is suitable for discharging preserving water at a preselected ratio, and is also suitable for preventing the invasion of microorganisms. After proper anesthesia has been made, the site for insertion of the drain shunt is selected. Guide holes may be formed that extend across the outer surface of the cornea, which extends through the matrix of the cornea and may also extend inward. The size of the guide hole may be determined by each operator based on surgical judgment and the anatomy of each patient. Many instruments that are familiar to ophthalmologists such as punctures, trocars, islets, and the like can be used to form guide holes or similar insertion sites. The shunt may be inserted into the extraction device by an operator or the shunt may be pre-inserted into the extraction device during its manufacture. While certain exemplary dimensions for the size of the shunt are disclosed herein, it will be appreciated that a range of sizes of the shunt may be used to suit the amount of variation in each anatomy. It will also be appreciated that various size extraction devices may be provided to engage different size shunts, or that a single size extraction device may be suitable for implanting all different size shunts. When the shunt is secured to the insertion tip of the extraction device, the operator advances the extraction device toward the outer surface of the cornea. When the extraction device reaches a preselected position of the cornea, the shunt is forced to its corneal location using the mechanism of the extraction device for advancing and displacing the shunt. When properly positioned to extend through the cornea, the shunt can drain the water on the cornea surface. Proper placement of the shunt can be confirmed by the presence of droplets of visible water on the head of the implanted device.

It is to be understood that the device of the present invention is useful for transplantation following a series of treatments that may be made by an increase in IOP, or as a temporary correction for a disease characterized by increased IOP. In the case of temporary correction following retinal surgery, cataract extraction, or other invasive eye surgery, the device of the present invention will be implanted for 2 hours to a month, or until the IOP is stabilized. On the other hand, permanent or long term implants with the device of the present invention will be used when treating glaucoma in diabetic patients.

It is to be understood that the specification provided with the foregoing drawings and descriptions is merely exemplary and specific embodiments of the present invention. It will also be understood that various changes and modifications may be made to the various components, structures of the stent, extraction systems and methods, without departing from the scope of the present invention. It is also to be understood that the invention is limited by the claims that follow.

Claims (31)

A substantially cylindrical body having a channel extending from the end of the base to the end of the distal end to discharge the aqueous fluid from the front of the eye to the outer surface of the clear cornea; A head disposed at the distal end of the body to engage the outer surface of the clear cornea and having a through opening in fluid communication with the channel to allow discharge of intraocular water but minimize entry of microorganisms; A foot disposed at a proximal end of the body to engage the inner surface of the cornea and having a through hole in fluid communication with the channel to enable introduction of intraocular water into the channel; And It can be inserted into the anterior chamber of the eye through the clear cornea of the eye, characterized in that it comprises an elongated filter that can be held inside the channel to regulate the flow rate of the aqueous fluid through the channel and further minimize the entry of microorganisms. Shunt. The shunt of claim 1, wherein at least one of the head and the foot is integrally formed with the body. The shunt of claim 1, wherein at least one of the head, the foot and the body comprises a dewaterable polymer. The method of claim 1, wherein the shunt comprises a dewaterable polymer such that dehydration of the shunt reduces the size of the shunt for implantation through a small incision of the cornea, and hydration of the shunt causes the shunt to shunt the cornea. Shunt, characterized in that to be securely fixed to. The shunt of claim 1, wherein the elongated filter can be removed from the channel. The shunt of claim 1, wherein the body comprises a hydrogel. The shunt of claim 6, wherein the hydrogel is covalently crosslinked and based on methacrylic acid derivatives. The shunt of claim 1, wherein at least one of the outer surface of the head and the outer surface of the foot is formed to minimize intercellular adhesion. The shunt of claim 1, wherein the outer surface of the body is formed to promote tissue adhesion. The shunt of claim 1, wherein the foot is tapered to facilitate insertion of the corneal shunt through the cornea. The shunt of claim 1, wherein the foot can be sized from a first shape to a second shape to facilitate insertion of the corneal shunt through the cornea. The shunt of claim 1, wherein the elongated filter can be held in the channel by tight contact. The shunt of claim 1, wherein the elongated filter can be held adjacent within the channel. A head suitable for placement on the outside of the cornea, which has a slit to allow discharge of the aqueous water but prevents entry of microorganisms and has an outer surface that resists adhesion between cells; A foot suitable for insertion forward across the cornea, more suitable for non-traumatic contact with the outside of the cornea, and having a hole to allow the passage of intraocular water; A tubular conduit between the foot and the head having an inner channel in fluid communication with the aperture and the slit and having an outer surface that resists intercellular attachment; And A corneal membrane to be ejected from the front of the eye, the filter being sized to hold in the inner channel and having an elongated filter for adjusting the inferencing rate of the aqueous water and preventing the invasion of microorganisms. Implants for Placement. A corneal shunt for draining intraocular water from the anterior to the outer surface of the cornea; And It is configured to include an extraction device for implanting the shunt in the cornea method, wherein the extraction device, An insertion tip releasably holding the shunt and sized appropriately to position the shunt for insertion through the outer surface, and An inserter slidable from a first position to a second position, wherein sliding the inserter from the first position to a second position removes the shunt from the insertion tip, such that the shunt is moved through the outer surface. Forced into the corneal position; The discharge of intraocular water from the front side by the shunt to the outer surface of the cornea reduces the intraocular pressure. 16. The corneal shunt of claim 15, wherein the corneal shunt has an elongated tubular body, a head, a foot, and a filter, the body having a channel extending from one end of the body to the opposite end to discharge intraocular water. The head is disposed at one end of the body so as to engage the outer surface, and has a slit in communication with the channel to enable the discharge of intraocular water on the outer surface and to restrict the entry of microorganisms, the foot of the inner surface of the cornea Disposed at opposite ends of the body so as to engage with and having a hole in communication with the channel to allow introduction of the water into the channel, wherein the filter regulates the flow rate of the water through the channel, And can be retained inside the channel to further restrict entry of a. 16. The system of claim 15, wherein the inserter includes a tip portion slidable from the front to the rear, and the extraction device further comprises a fixed plunger coaxial with the slidable tip portion. The system of claim 15, wherein the extraction device further comprises a fixed end tip portion, wherein the inserter comprises a slidable plunger coaxial with the fixed end tip portion and movable from front to back. Providing a shunt for draining intraocular water from the front to the outer surface of the cornea; Having an insertion tip releasably holding the shunt and sized to be suitable for positioning the shunt for insertion through the outer surface, displacing the shunt from the tip and through the outer surface to the corneal position Providing an extraction device having an inserter for forcing a shunt; And An anterior fluid, comprising using an extraction device such that the intraocular water can flow from the anterior to the outer surface by inserting the shunt into the corneal position across the cornea to reduce anterior fluid pressure. Method for reducing pressure. 20. The shunt of claim 19, wherein the shunt has an elongated tubular body, a head, a foot and a filter, the body having a channel extending from one end to the opposite end for discharging intraocular water, the foot being in the cornea. Disposed in one end of the body so as to engage with an inner surface of the body, and having a hole in communication with the channel to enable inflow of intraocular water into the channel, wherein the head is disposed at an opposite end of the body, And a slit in communication with the channel to enable discharge of the water on the outer surface, the filter controls the flow rate of the water through the channel and further restricts the entry of microorganisms. A method that can be held within a channel. 20. The method of claim 19, further comprising forming guide holes through an outer surface to enable insertion of the shunt. 20. The method of claim 19, further comprising removing the shunt after a preselected period of time. 23. The method of claim 22, wherein the preselected period of time is less than one month after surgery. 23. The method of claim 22, wherein said preselected period of time is at least one month. The method of claim 22, wherein said preselected period of time is at least 2 hours after a surgical operation. A head having an outer surface in contact with the tear film and at least intermittently in contact with the eyelid, protruding from the cornea, the outer surface being wetted with tears, highly hydrated, and resistant to intercellular adhesion; A body comprising a hydrogel and having an outer surface in contact with the stromal tissue of the cornea, the outer surface having a lower hydration than the outer surface and promoting intercellular adhesion; And A corneal implant disposed in the cornea between the tear film on the outside of the cornea and the anterior side of the eye, comprising a foot protruding forward. 27. The implant of claim 26 wherein the body is penetrated by an inner cavity having an inner surface. 29. The implant of claim 27 wherein the inner cavity includes a channel connecting the tear film and the anterior chamber. The implant of claim 28, wherein the channel comprises a filter that blocks the passage of microorganisms. Casting a mixture comprising HEMA, methacrylic acid, dimethacrylate crosslinker, and a free radical initiator in a single part silicone mold having a cavity formed by printing into a die molded into a preselected shape Method for preparing corneal implants. A method for producing a corneal implant comprising machining a shunt and applying a tissue complete layer to the outer surface of the shunt, wherein the tissue complete layer comprises a copolymer of alkyl methacrylate and HEMA, monomer HEMA, dimethacrylate. A process comprising the curable component comprising a crosslinking agent, a free radical initiator and a volatile solvent.