KR20070035529A - Ophthalmic implants and methods of manufacturing the same and methods of using the same - Google Patents

Abstract

An ophthalmic implant device 10 is provided that can be inserted into either the anterior or posterior of the eye to drain the aqueous humor and / or to introduce a medicament. The implant may comprise a substantially cylindrical body having a channel portion that regulates the flow rate of the intraocular fluid from the front or introduces the medicament back, while at the same time minimizing the introduction of microorganisms into the eye.

Implants, Shunts

Description

Ophthalmic implants and methods for making the same and methods of using the same {Ocular implant and methods for making and using same}

This application is the partial-continuation of US patent application Ser. No. 10 / 182,833, filed December 27, 2002, which is the domestic stage of international application PCT / US01 / 00350, filed January 5, 2001, which is year 1 000. Claims priority of US Provisional Application No. 60 / 175,658, filed May 12, the entire contents of each application are hereby incorporated by reference. International application PCT / US01 / 00350 has been published in English in accordance with PCT Article 21 (2).

FIELD OF THE INVENTION The present invention relates to ophthalmic implants and, more particularly, penetrates the cornea of the eye to lower intraocular pressure, and also penetrates the sclera to introduce the drug into the posterior chamber of the eye. And filtered and / or flow restrictive ophthalmic implants for use. As such, embodiments of the present invention can be used for both transcorneal and transscleral applications.

Glaucoma, a condition caused by optic nerve cell degeneration, is now the second most common cause of preventable blindness worldwide. The main symptom of glaucoma is high intraocular pressure or "intraocular pressure", which is caused by the inability of the trabecular meshwork to adequately drain the aqueous humor fluid from the eye. Thus, conventional glaucoma therapies can be achieved by inducing low IOP by using a variety of methods, such as surgery or drug treatment, which protect the optic nerve and involve surgical methods such as the use of drugs or trabeculectomy and the use of implants. The aim is to protect the optic nerve.

Trabeculectomy is a very invasive surgical method in which no device or implant is used. Typically, surgical methods are made to puncture or reshape the trabecular column by surgically forming a channel to open the sinus venosus. Other surgical methods commonly used include the use of implants, such as stems or shunts, placed inside the eye and typically very large. The device is implanted during a number of surgically invasive processes and serves to lower internal intraocular pressure by allowing intraocular fluid to flow from the anterior chamber into the conjunctive bleb above the sclera. This method is a labor intensive task for doctors and often fails due to scarring and cyst formation.

Other problems related to the method often include drug delivery. There is currently no efficient and effective route of drug delivery to the eye. Most drugs for the eye are applied in the form of drops of eye drops that penetrate the eye through the cornea. Drops are a very inefficient way of delivering drugs, and many drugs don't reach inside the eye. Another method of treatment includes injection. Drugs are injected directly into the eye, but this method is often for trauma and the eye usually needs to be injected regularly.

One solution to this problem with drops and infusions involves the use of transcornea shunts. Corneal shunts have also been developed as an effective means to reduce intraocular pressure inside the eye by shunting the sap from the front of the eye. The corneal shunt is the first device provided for draining intraocular fluid through the cornea, which makes surgical device implantation less invasive and faster than other surgical methods. A detailed description of the application of additional shunts is described in international patent application PCT / US01 / 00350, filed Jan. 5, 2005, entitled "Systems and Methods For Reducing INtraocular Pressure", which was issued on July 19, 2001. Published under publication number WO 01/50943, which is hereby incorporated by reference in its entirety.

However, as mentioned in the application PCT / US01 / 00350, existing shunts face many problems. The first problem associated with the use of shunts is the control of aqueous runoff. This problem is typically due to the fluid's discharge rate being significantly dependent on the implant's mechanical properties until there is sufficient wound treatment to physiologically limit the outflow of the fluid. Effective balance of physiological and mechanical resistance to aqueous humor outflow remains a problem for implant-based ejection processes. Conventional devices use a variety of mechanisms to limit such aqueous emissions. However, each of these instruments is liable as long as the wound is treated. Restrictive elements in the implant, in combination with the restrictions performed by wound treatment, will abnormally reduce the rate of bleeding outflow to non-therapeutic levels.

The second problem associated with conventional shunt use is the possibility of transmission within the eye. Unfortunately, the presence of the implant causes intraocular infection by providing a conduit through which bacteria can be introduced into the anterior chamber. Certain drain devices introduce filters, valves, or other conduit systems that serve to inhibit the spread of infection to the front, but such mechanisms are limited. Although effective in inhibiting the passage of microorganisms, such devices have hydraulic effects on fluid outflows that impair effective discharge.

Finally, conventional devices create a problem of local tissue tolerance because the implant can prevail local inflammation or extrusion as a foreign material, causing a tissue reaction. This may be perceptible or uncomfortable for the patient, and its therapeutic use may be inappropriate because of this response to the presence of the implant.

Thus, there is a need for transmembrane shunts or implants that control anterior chamber drainage while limiting the ingress of microorganisms. In addition, a device that allows the drug to pass through the cornea and into the eye over an extended period of time so as not to cause repeated injuries to the eye, typically associated with repeated infusion, and also to enable continuous infusion into the eye and There is a need for a method.

It is therefore an object of the present invention to provide an apparatus and method that can be used to lower IOP by draining the intraocular fluid from the front of the eye in a controlled manner.

Another object of the present invention is to provide an apparatus and method that can be used to deliver a substance, such as a drug, to the posterior chamber of the eye.

It is another object of the present invention to provide an apparatus and method having an appropriate size, shape and composition for a variety of applications and that can be used as an implant comprising one or more filters, valves or restrictors to form a suitable reaction by the implant. To provide.

These and other objects are substantially achieved by providing an implant that can be inserted forward through the clear cornea of the eye to drain the aqueous fluid, or similarly through the sclera to introduce the drug into the back of the eye. . The implant includes a substantially cylindrical implant having one or more channels that allow the release of intraocular water from the front to the outer surface of the clear corneal or allow the release of material into the back of the eye. The implant can control the flow rate of the head, which rests against the outer surface of the clear cornea or sclera, the foot that rests against the inner surface of the cornea or sclera, and intraocular water and minimize the introduction of microorganisms. It may further include one or more extended filter members that can be held inside the body channel to enable.

The above and other objects and advantages will be apparent in view of the drawings and detailed description below. Preferred embodiments of the invention are shown in the accompanying drawings, wherein like reference numerals designate like elements:

1 is an enlarged perspective view of an implant according to one embodiment of the present invention;

2 is an enlarged cross-sectional view of an implant according to one embodiment of the present invention:

3 is another enlarged cross-sectional view of the implant of FIG. 2:

4-15 are enlarged cross-sectional views of several implants in accordance with one embodiment of the present invention;

16-19 are enlarged cross-sections of examples with implants in accordance with one embodiment of the present invention.

20-22 are enlarged cross-sectional views of several implants in accordance with one embodiment of the present invention;

Figures 23 to 24 are enlarged cross sections of an example in which several implants are mounted according to one embodiment of the invention;

25-28 are enlarged perspective views of an implant according to one embodiment of the present invention;

29-36 are enlarged cross sections of several implants according to one embodiment of the present invention;

37A and 37B are enlarged cross sections of a capillary filter in accordance with one embodiment of the present invention;

37C and 37D are enlarged cross sections of examples of hollow fiber components such as those provided in the filter of FIG. 37A;

38-42 are enlarged cross-sectional views of several additional examples of capillary filters according to one embodiment of the present invention;

43-45 are enlarged views of implants that may include the features of FIGS. 1-42, in accordance with one embodiment of the present invention.

In the drawings, it will be appreciated that like reference numerals refer to like structures.

Corneal shunts or implants (hereinafter referred to as "shunts") serve several purposes, such as to reduce the intraocular pressure (IOP) of the eye by bypassing the sap into the terafilum through the cornea from the front of the eye. Has been developed. To do so, the shunt must be inserted through the small incision into the cornea of the eye, between the inner and outer surfaces of the actual cornea. In another application, the shunt may be inserted to introduce material into the back of the eye through the sclera.

As shown in FIG. 1, an enlarged perspective view of a shunt according to one embodiment of the present invention can be seen. In an exemplary embodiment, the shunt has an outer diameter of about 0.5 mm and may be about 1 millimeter long. Although the shunt is shown as a columnar structure in this figure, it is recognized that other tubular conduits may also be formed. For example, the shunt may be elliptical or indefinite as described in more detail below.

1 shows a shunt 10 applied at the corneal position in dimension. Head 12 is located on the outer or epithelial surface of the cornea when the shunt is located inside the cornea. As shown in the figure, the head 12 may be dome-shaped to provide a continuous transition surface to the cornea in the device. This shape may also be well tolerated by the patient's eyelids. While the shape looks particularly advantageous, other head shapes can be designed to provide the same advantages. For example, flat heads with rounded corners and minimally projecting can be equally well tolerated. The underside (not shown) of the head 12 may be flat or curved to preferably match the shape of the corneal surface on which the device is located. The head 12, the main body 14 and the foot 16 may all be formed integrally as one unit, or the head or the foot may be formed integrally with the main body.

In one embodiment of the invention, as shown in FIGS. 2 and 3, the shunt 100 includes a distal or proximal end that includes a head 102 and a foot 104 body, respectively. It is shown that the main body 106 is extended therebetween. Opening 108 is provided between the distal end or the proximal end to allow fluid delivery. The opening includes a narrow portion 110, between which a thin layered flap unfolds, which is more clearly shown in the cross-sectional view of FIG. 3. The solid member 112 covers the narrow portion 110 and has a substantially semi-circular shape that allows the flap to remain in a closed position until minimal pressure is applied from the remote direction of the opening. The branch includes a flap 114. The flap is then opened to regulate the flow from the remote end to the proximal end of the opening.

As used herein, the term "proximal" refers to the location furthest from the patient used in connection with the device on any device. In the opposite sense, the term "distal" refers to the location closest to the patient on which the device is connected and used.

The flap 114 is composed of a material such as a hydrogel so that the flap opens easily. The flap circumference is contoured to open in only one direction, thereby preventing backflow from the proximal end of the opening to the remote end. In particular, flap 114 may be molded to have a tapered or sloped outer circumference that mates with a similar surface around the inner circumference of opening 108. The sloped surface, shown more clearly in the cross-sectional view of FIG. 2, restricts the flap opening in a single direction and prevents microorganisms from entering the opening 108.

The opening also includes a wider portion 116 in which the filter 118 can be located. The filter may include any number of filters as known to those skilled in the art or may include improved filters as described in more detail below.

In the embodiment shown in FIG. 2, flap 114 and filter 118 both form a fluid shunt between the outside and inside of the eye surface. The filter and shunt body can be formed in various ways in accordance with various embodiments of the present invention. For example, filter 118 is shunt (ie, the filter body is substantially solid and serves as a substantial shunt). In another embodiment, the opening provided in the head of the shunt serves as a filter (ie takes a particular valve mechanism).

As shown in shunt 120 of FIG. 4, an opening or one-way valve 122 is provided between the narrow portion 126 or the wide portion 128 of the opening 124, respectively. . In the embodiment shown in FIG. 4, no filter is provided and valve 122 controls the flow from the remote end to the proximal end and prevents backflow within the opening. As with the flap 114 shown in FIGS. 2 and 3, the one-way valve 122 may be a tapered or inclined surface that mates with a similar surface around the inner circumference of the opening 124.

In an embodiment of the invention described below, a filter, such as filter 118 of FIG. 2, may be ceramic, coral, stainless steel, titanium, silicon, or PHEM (i.e., poly) depending on the particular challenges required. 2-hydroxyethyl methacrylate), and any number of polymeric materials. In addition to stainless steel, any metal that can provide a more robust filter can be used. Metals, or similar materials that are resistant to bacteria to some degree, such as silver or platinum may also be used. The device, filter or combination may be incorporated into a number of such antimicrobial agents such as coatings, impregnations or building materials and may contain ions such as copper, zinc or silver (ie, vapor deposition silver plating). Sex metal compounds; Antimicrobial polymers such as polyhexamethyl biguanide (PHMB) and liquid crystal polymers (ie, insoluble precipitation through the loss salt method); Organic compounds such as alkyl trypsin, biguanide, triclosan organic compounds and CHG (chlorohexidine); Infused bacteria and inorganic compounds such as quaternary ammonium salts and metal oxides.

Since bubbles are less likely to clog the filter, the filter may be composed of titanium, which can be further oxidized to increase hydrophilicity and enhance flow rate. Another filter material includes soluble / insoluble glass in which the glass dissolves and includes a replaceable antimicrobial agent. An example of an insoluble glass material would be a glass frit made of glass fiber or particles.

Such a filter may be composed of glass spheres that are vacuum plated with antimicrobial material. Such spheres may be provided as filters that are allowed to move in larger openings, or consist of bonded spheres, and may further include silver ions that are time release impregnated on such soluble glass spheres. Many 3.5 microspheres provide 0.5 micron holes if fixed with a material such as a cellulose binder.

The filter includes a glass capillary restrictor 132 flow restrictor comprising a plurality of holes through holes used to effectively control the flow between the remote and proximal ends of the opening 134 as shown in FIG. flow restrictor). In addition to controlling the flow, a number of penetrating holes can be used to prevent bacterial penetration. Capillary restrictor configuration 142 as shown in shunt 140 of FIG. 6 may be incorporated into a head or cap 145 located at the proximal distal end of the opening. In such an embodiment, the cap portion covering the opening may be provided with a hole section 142 to control the flow and prevent bacterial penetration, and may include filters (ie, 118 and 132). )) May be omitted. Each of all of the holes in section 142 may be provided in plural or singular, or may be enclosed in an enclosing tube with an antimicrobial agent and further provided with a very smooth surface.

In another embodiment of the present invention shown in FIG. 7, the cap 155 covering the opening 154 of the shunt 150 has a porous hydro to control flow (ie, controlled diffusion) and prevent bacterial penetration. It may consist of a membrane 152, such as a gel membrane, and the filters (ie, 118 and 132) may be omitted. Hydrogels may be provided to allow epithelium to grow over the cap 155, resulting in a membrane 152. The epidermal membrane allows the fluid to diffuse and can prevent bacterial penetration.

In each of the embodiments described above where a filter, membrane or capillary cap portion is used, multiple components can be used in combination. As shown in shunt 160 of FIG. 8, a stacked filter 162 comprising two or more independent filters or screens having various pore sizes and configurations may be used in combination. Selection and combination of stacked filters can be used to control the flow and optimize bacterial penetration. For example, the stacked filter 162 may be comprised of one or more drilled and stacked plates, glass disks in tubes, silicon stacks, or one or more silver plates, fibers or screens, each of which is of varying diameter through. Slotted openings may be provided that provide through holes or increased flow rates. The spacing and location of the stack may be used to form biotraps, multiple chambers, tortuous paths (ie coil paths), tubes or channels. The plate may also consist of an embossed or engraved plate, or an engraved layer of plates with a more unique structure, such as a honeycomb arrangement. In a similar manner, the plate may be made of a material that can be arranged to form a semiconductor grid or polarizer.

The shunt body itself may consist of any number of materials, including ocular hydrogels (ie, polyhydroxyethyl methacrylate-methacrylic acid copolymer (polyHEMA-MAA), polyHEMA, copolymers and Hydrogels of other expansion materials), silicones, PMMA (ie polymethylmethacrylate), hyaluronic acid, silicone / hydrogel compositions, silicone acrylics combination) and fluorosilicone acrylate, and the like, but are not limited thereto. Such silicone materials have high strength, contain a higher degree of useful oxygen permeability and exhibit a high degree of protein and lipid deposition resistance. In addition, the use of silicone combinations, such as silicone / hydrogel combinations, also combines the advantages of each.

The constituent material of the shunt body can be selected from the above materials and can be processed in any number of ways in accordance with embodiments of the present invention. For example, the shunt body 170 may be constructed in a porous manner that does not require a filter, as shown in FIG. 9. The porous material, which is the shunt body itself, serves as a filter and / or fluid delivery means, and the choice of material can be used to construct a shunt body that effectively functions as an effective filter for a particular application, based on the possible pore size. have. Another shunt component may be selected to include a layer of material applied to the exterior of the shunt. Such materials, such as silver nitride, can be used to minimize neovascularization and protein deposition or to serve as antimicrobial agents. The shunt body may also contain a coating material and / or surgical adhesive, such as Bioglue ^® , fibrin-based glue, marine adhesive protein available from Cryolife Inc. of Kennesaw, GA. proteins, ie algae), and synthetic polymeric adhesives such as cyanoacrylates may be provided.

Any of the above materials can be used in various combinations to form a shunt body having a surface roughness or texture of two or more levels. For example, as shown in FIG. 10, the proximal distal end 185 of the shunt 180 may be configured to include a smooth surface for comfort on the cornea and eyelids, while the shunt body extends between the remote and distal ends. 181 may be configured to have a rough surface for strong cell attachment. In addition to having more than two levels of surface roughness, each embodiment may include a shunt body that extends substantially between a circular, elliptical, or irregularly shaped remote and proximal distal end as shown in FIGS. 11 and 12. . The irregular cross section, such as the star cross section of the shunt 190, allows the shunt to be better secured to the eye. The various shapes of the shunt body section also allow the use of multiple incision patterns, such as X-, O-, and T-shaped incisions. Once the constituent material is selected, multiple shunt body shapes can be used to effectively carry out embodiments of the present invention.

  As mentioned above, the shunt body that extends between the remote and proximal distal ends may be substantially circular, elliptical or indefinite. As shown in FIG. 13, the shunt 200 can be configured to have an indeterminate remote or proximal distal end 207 and 205, each of which serves a particular application. For example, as shown in FIG. 13, the shunt cap portion 205 is configured to have a martini glass shape. These martini glasses and similar and similar shapes can be effectively used to prevent shunt jets, each of which is generally more comfortable to the eye because it minimizes foreign body irritation. In addition, such shapes indicate minimal leakage after initial transplantation. In so configuring the device, the cap, or proximal end of the shunt may be overmolded to provide a smooth finish.

Another shape according to one embodiment of the invention is shown in FIGS. 14 and 15. Shunt 210 includes distant and proximal distal ends, of which distal distal end 217 is modified during and after implantation. In this case, the inserted remote distal end 217 can be deformed or reduced to a smaller shape as shown in FIG. 14, so this installation requires a smaller incision. As shown in FIG. 15, after successfully reaching the inner surface, the remote end 217 expands to a larger size by hydration or exposure to body temperature. Such a structure allows for easier transplantation.

The shape may be homogeneous with the insertion portion as shown in FIG. As is known to those skilled in the art, shunt grafts can be made at the sclera corneal junction. At such an implant site, the distant and proximal ends of the shunt 222 may be configured to angle with respect to the shunt body extending therebetween. The relative angles of the embodiment shown in FIG. 16 can be further modified as shown in shunts 226 and 228 of FIGS. 17 and 18, respectively, for specific site locations, such as the clear cornea. In such installation applications, consideration may be given to the ability to hold the shunt in place. Specifically placing the shunt at the limbus (eg, the edge of the cornea overlapped by the sclera) may function to secure the remote end or foot of the shunt in place as shown in FIG. 19.

As mentioned above, the shunt body may be provided with a coating material, such as a surgical adhesive. Using surgical adhesives during implantation ensures a seal and / or ensures placement of the shunt. More effective use of surgical adhesives is provided when used in conjunction with stitch stitch procedures. For example, the implantation process typically requires the formation of an about 1.5-1.6 mm incision in which the distant distal end or foot of the shunt is located. In an alternative method, the procedure may require incisions and sutures in order for the shunt to be securely located.

The filter provided in this embodiment may further be provided with any number of micro devices, such as micro-mechanical pump 242, as shown in shunt 240 of FIG. 20. Such techniques and devices may be used to replace the filters, valves and restrictors described above.

In each of the embodiments described above, the filters, restrictors and / or micro-devices may be permanent, removable and / or replaceable. Thus, the user may have the option of using a shunt with a removable and replaceable filter so that if the filter is clogged there is no need to replace the entire shunt by replacing the filter. For example, as shown in FIG. 21, the filter 252 of the shunt 250 can be replaced simply by pushing it from the opening. Such replacement can occur if the filter is clogged or to maintain performance levels at regular intervals. Replacement may also occur if the user wishes to change the flow rate or shunt flow characteristics. Replacement may also occur if a filter is used to introduce the drug into the eye.

The replaceable filter described above can be configured in a manner suitable for easy replacement, installation and verification in a number of ways. As shown in FIG. 22, the opening in the head 265 of the shunt 260 may be configured to have an entry widened above the hole in the opening 364, which causes the filter to move into the opening by an unintended distance. To prevent further removal and replacement from the proximal end of the shunt.

In another embodiment of the present invention that allows for easier insertion, the shunt includes a coupling mechanism for use with a device such as an external pump. In the embodiment shown in FIG. 23, the shunt 272 is configured to be inflatable. Once located in the small incision of the eye 274, an external pump 276 can be used to allow the shunt 272 to expand after implantation. Thus, the shunt may be smaller in size prior to expansion, thereby requiring smaller incisions for easier implantation. The expanded shunt 274 also more effectively fills the leak gap. As shown in FIG. 24, the shunt 282 described above may be implanted using a suture 286 to pull the shunt through the incision and into the cornea 284. Another implantation technique involves shooting the shunt to the appropriate implantation location. The construction of the shunt may be adapted to enable implantation using such techniques, in addition to removal techniques using any number of devices, such as a phacoemulsification machine.

In another embodiment, as shown in FIGS. 25-28, the shunt 290 may be configured to have a straight proximity 297. The straight proximity 297 replaces the circular proximity of the embodiment described above. This typically makes it easier to insert into a linear incision. Upon insertion the shunt 290 is perpendicular to the incision axis and thereby rotates substantially 90 degrees to replace the straight proximity 297 that secures the shunt 290.

The various embodiments described above can be used to construct shunts that are acceptable for any number of purposes, such as methods that can lower IOP after corneal transplantation or cataract surgery. It may also be used for veterinary or cosmetic use. The shunt body may also be used essentially as a catheter for the eye. As shown in FIG. 29, the proximal distal end 305 of the shunt opening 304 may be covered, sealed, or provided with a slit to form an intracorneal portion for infusion or infusion of the drug.

The proximal end or head of the shunt may be provided with means such as color or shape to indicate the type of shunt. Similar means may be provided, such as an indicator color that appears more clearly when the remote end or foot of the shunt is correctly positioned forward.

As mentioned above, embodiments of the present invention may be provided as a corneal implant device for lowering intraocular pressure or as a transmucosal device for introducing a medicament into the back of the eye. For example, as shown in FIGS. 30, 31 and 32, the implant device or shunt 310 may be made of a hydrogel material that absorbs the drug, or may be made of a porous material such as ceramic or titanium. It may also be a casing of hydrogel material surrounding the drug containing porous material 312, where the hydrogel or porous material 3112 is posterior to the eye at a controlled rate (ie, controlled diffusion). To release the drug. The device 310 is secured to the cornea or sclera by a flange 317, substantially as described above, and also secured by a coating to the exterior of the device. Such coatings may be porous or chemically modified to induce cellular attachment. Therapeutic agents or sustained-release drugs that can be released into the eye include immune response modifiers, neuroprotectants, corticosteroids, angiostatic steroids, and antiglaucoma drugs. anti-glaucoma agents, angiogentic compounds, antibiotics, radioactive agents, anti-bacterial agents, antiviral agents, anticancer agents, anti-clogging agents And any number of substances including anti-inflammatory agents.

The embodiment of the present invention shown in FIGS. 30 and 31 shows an example of a device having a hydrogel material package surrounding the porous material 312, wherein the hydrogel or porous material is used to control the drug to the rear of the eye at a controlled rate. To emit. The device has been implanted through the sclera and the drug is slowly delivered to the eye and can be provided as a permanent or short term implant. As shown in FIG. 30, the implant may comprise remote and proximal distal ends, 317 and 315, respectively, with the shunt body 311 extended therebetween, the opening being a porous filter containing the drug ( 312). The outer surface of the shunt body 311 extending between the remote and proximal distal ends may comprise a porous or chemically formulated external layer or coating to induce cellular attachment or growth. The outer surface of the shunt body 311 may be provided with a porous layer or a titanium and / or ceramic coating, which is stored in any drug pores required or additional thereto. The remainder of the shunt 310 may be configured as a hydrogel package.

The proximal distal end or head of the shunt 310 may be comprised of a porous or nonporous hydrogel containing the absorbed drug. In another embodiment of the present invention shown in FIG. 32, the entire shunt 320 can be composed of a porous or nonporous hydrogel and can be provided without a filter.

Embodiments of the invention described above are primarily provided as long-term implants that can be used to deliver drugs to the eye over any number of extended periods of time. As such, the embodiments do not cause injury to the eye caused by repeated infusions, but also allow for gentle and continuous infusion into the eye. Details of such long-term implants are mentioned in US Patent Application No. 10 / 182,833 (Systems and Methods For Reducing Intraocular Pressure), and US Patent 5,807,302 (Treatment For Glaucoma), Each full text is hereby incorporated by reference.

In another embodiment of the present invention shown in FIG. 33, the shunt 330 can be configured as a porous flow control device comprising an antibiotic and an anti-infective agent. As described for each of the above embodiments, the device changes the direction of the water flow from the front to the tear film to lower the intraocular pressure or introduce the material to the rear depending on the application and shunt position. It is arranged to penetrate either the cornea or the sclera so that one end is on the surface of the cornea, edge or sclera, and the other end may be located in the front or the back.

As shown in FIG. 34, the shunt 340 may also include a porous filter structure to provide the desired flow resistance required for discharging the backwater at a controlled rate. Anti-infectives or antibiotics in the porous filter structure pass filter 342 from the outside of the eye to prevent bacterial penetration forward. The shunt body outer surface 341 in contact with the tissue may have porous or spongy tissue to facilitate cellular ingrowth and to secure the device to the eye. Porous filtration device 342 may provide an antibiotic or anti-infective agent in a structure that prevents bacterial infiltration and reduces the risk of infection. The porous filtration device structure may also provide a distorted pathway to further prevent bacterial penetration. Narrow openings 346, which are also located at the proximal end of the opening or channel 344, may provide a barrier to bacterial penetration.

Existing devices incorporate filters having a pore size of typically 0.20 micron for shunts for bacterial protection. The 0.20 micron filter, however, substantially limits the flow through the device so that the size of the filter area required to reach the desired flow rate is not realistic. If antibiotics or anti-infectives are used in structures with larger pore sizes, the required flow resistance can be obtained even in smaller devices. As such, when such a material is used, the shunt may be smaller than any existing device that includes a device such as a anti-bacterial device. In addition, porous structures with pore sizes greater than 0.2 micron are less likely to be clogged than devices that use 0.2 micron filters as a means to prevent bacteria. Small devices are also less likely to cause stimulation and rejection problems and can be more easily deployed without disturbing the field of view or externally paying attention.

The pore nature of the device in the area where it is in contact with tissue also has the advantage of allowing cellular internal growth, which helps the tissue attach to the device and allows the device to be placed more reliably in the eye. . This helps to prevent undesirable release after the device is implanted.

As is known to those skilled in the art, the flow rate in such devices is directly related to the pore size. As mentioned above, the existing filter device was equipped with a filter having a pore size of about 0.2 micron in diameter to physically prevent bacteria from penetrating forward. Filters having such pore sizes excessively restrict flow, thereby making the required filter area too large, necessary to reach the required flow rate. This results in the mechanism being larger than desired. However, if antibiotics or anti-infective agents are added, filters with large pore sizes can be used to have similar or superior bacterial barriers, and desirable flow restrictions can be obtained even with smaller devices.

In addition, conventional filter devices that treat glaucoma by bypassing fluid from the anterior to the tear duct typically do not have means to promote cellular internal growth to help tissue attach to the device. The outer porous nature of the embodiments described above has the advantage of promoting cellular internal growth, which helps cells adhere to the device, and the device can be more securely fixed in place.

Some concepts of the shunt for draining the water into the tear film from the front also include valve mechanisms, but many have only one-way valves. Such valves may not prevent bacteria from penetrating through the valve, thus increasing the risk of infection. The filtration device of this embodiment thus solves this problem by providing a distorted pathway in which the anti-infective agent killing bacteria before entering the front is contained throughout the filter 342.

The embodiments shown in FIGS. 34-36 include porous metal, ceramic, or plastic cylindrical filters of 342, 352, and 362, respectively, each having an outer diameter ranging from about 0.001 to about 0.03 inches. , Between about 0.020 and about 0.030 inches in length. Pore sizes range from about 0.20 to about 15 microns in diameter, depending on the material, surface area, and thickness. Each of the porous filters 342, 352, and 362 contains an anti-infective or anti-infective compound coated within its structure, which may be a silver compound, an antibiotic, or a wide variety of other anti-infective agents, which are biocompatible. to be. The filter thickness also provides a distorted pathway containing a material coating or compound that can prevent bacteria from penetrating for an extended period of time.

34 and 35, the cylindrical filters 342 and 352 are each sealed to a silicone or hydrogel tube or channel 344 and 354, respectively, which are proximal end portions 345 and 355, respectively. Each includes a smooth curved flange, each with openings 346 and 356 that are shaped like the surface of the eye, such as contact lenses, but through which the intraocular water can flow. Remote ends 347 and 357 each have a flange that secures the device and prevents release. Each of the outer tubes 341 and 351 protects the tissue from the toxic effects of the anti-infective agent and is made of soft material. As in this embodiment, a portion of the tube is in contact with a tissue comprising sponge texture so that cellular internal growth can occur. 35, valve 353 may also be provided to control the flow rate through porous filter structure 352 that further incorporates an anti-infective. Another embodiment of the valve is a 'poppit-type' valve, a 'blow-off type' valve, a user activated valve, as is known to those skilled in the art. Vernaty ^TM valves, duck-bill valves, umbrella valves, pressure cracking valves and dome-over valves may be included.

As also described above, the fully porous ceramic portion 360 may be configured to have an impregnated biocide as shown in FIG. 36. The ceramic can be a bioinert, bioactive and / or biocompatible material, such as alumina or hydroxyapatite. The anti-infective agents used may also be bioinert at the required properties such as silver compounds or at increased concentrations of ocular natural anti-infective agents.

The shape of the shunt 360 may be similar to that described above, and may also be provided with a series of mechanical engagement threads 369 as shown in FIG. 36 to secure inside the tissue, such as a mechanical screw. It may also include. Another joining technique may use multiple protrusions, such as detent, indentation, or tabs (not shown) for fixation within the tissue.

The fully porous ceramic portion can be configured to have pores of about 0.2 microns. In this embodiment, the device does not require a valve channel and / or a separate filter structure and because of the pore size in a single, intergral device, the device controls the flow resistance and provides an external biocompatible structure. It can also prevent bacterial penetration. The structure of the ceramic portion may also be made to have a larger pore size for greater flow rates and to have a very thin layer (eg about 0.2 micron) sprayed or deposited on the surface. It is also possible to construct the model such that the fully porous titanium part has a bioside impregnated using the sintering method.

In this embodiment, the shunt, implant, or filter therein is configured based on the relationship between pore size and flow rate. The larger the pore size, the higher the flow rate in the device. This makes it possible to manufacture very small devices that can effectively control the flow of the glaucoma filtration device. Additional effects include the use of anti-infective agents that can kill bacteria and prevent their penetration. Anti-infective agents can be used in combination with the distorted pathway structure formed by the porous material. The use of a porous structure also allows for intracellular growth when implanted in the human body and promotes cell adhesion to the device surface.

The device may be used as a drug delivery device. Specifically, the embodiment may include a drug that dissolves over time in the porous filter or body material and is released into the eye. In another application, the device can be used as an instrument (ie catheter) for injecting drugs into the eye. It may be a temporary implant or an ophthalmic catheter. Related materials include U.S. Patent 5,807,302 (Treatment of Glaucoma), U.S. Patent 3,788,327 (Surgicai Implant Device), U.S. Patent 4,886,488 (Inventory: Glaucoma Drainage the Lacrimal System and Method ), US Pat. No. 5,743,868 (named Corneal pressure-Regulating Implant Device) and US Pat. No. 6,007,510 (name: Inventable Devices and Methods for Controlling the Flow of Fluids Within the Body), respectively. The entirety of is incorporated herein by reference.

In another embodiment of the porous body or filter in the device, a hollow or capillary action micro-device can be provided as shown in FIGS. 37-42. The flowable micro-devices of FIGS. 37-42 are designed to be part of the pressure relief insert, implant or shunt described above, and can serve as a check valve to release the elevated pressure of the eye.

As shown in FIGS. 37A-37D, a hollow or capillary action micro-device 370 is potted to secure one or more hollow porous fibers 373 surrounded by a plastic cylinder 375 in a channel of an implant or shunt. ) May be composed of an elongated porous filter composed of a base 371. The fibers may be sealed or sealed at the first end 379 and open inside the base 371 at the second end and secured to the fluid delivery opening. Over the length of the fiber 371, the porous wall surrounds a substantially hollow center and extends along the axis of the shunt inside the plastic cylinder. The porous fiber creates a very large filtration area for the micro-device 370, and a non-limiting flow is provided through the enclosing plastic cylinder 375, hollow fiber center and delivery openings inside the base 371. . The fiber configuration thus provides maximum flow through the restrictive porous opening along the fiber length.

The use of hollow porous fiber technology can be used to increase the effective filtration area when inserted into the implant body described above. The waterproofing moves to the shunt channel and also through the open distal end of the base 371 to the substantially hollow fiber 373 center. Since the fiber is closed at the opposite end 379, the waterproof is forced to move through the porous layer of fiber to avoid the fiber 373. The waterproof then enters the plastic cylinder 375 and is subsequently released through the shunt channel to the surface of the eye. As shown in more detail in FIGS. 37C and 37D, the hollow fiber filter 373 provides a substantially cylindrical element with the first end 379 sealed. As the aqueous material enters the substantially hollow fiber through the open end opposite the fiber 373, it must be released through the porous material of the fiber body. These pores of the fiber 373 may be uniformly distributed throughout the fiber body, or may be provided to have a gradient pore size, from small to large, as measured radially outward from the center of the fiber.

The potted base 371 may consist of a substantially circular disk of about 0.020 inches in diameter, with hollow porous fibers 373 secured to and extending from opposite sides of the base, as shown in FIGS. 37A and 37B. And one or more openings connected together. The length, inner diameter and porous wall arrangement (ie pore size and slope) of the fibers 373 may be arranged to achieve the desired filter / limiting results required for the application. In addition, the constituent material may include materials such as those described above to help achieve the desired results. As described in more detail below, the hollow or capillary action micro-device may also be performed as two piece members bonded to achieve substantially the same result.

As shown in FIGS. 38 and 39, other hollow or capillary action micro-devices may be comprised of two or more separate parts 372 and 374 bonded to one another. As known to those skilled in the art, the bonding can be performed using laser welding techniques in the range of about 800 nm to 1000 nm or more. In one or more portions of the device, the maze of the capillary container 376 is implanted or embedded. Capillary vessel dimensions and their geometry are calculated and manufactured to meet the parameters required to relieve eye pressure.

As shown in FIG. 40, the capillary container portion 376 may be configured to have a straight profile extending over its entire length, and formed to have a diameter of about 0.001 mm. Another variation of the capillary portion is shown in FIG. 41, where the capillary vessel 377 appears to have a substantially sinusoidal wave shape extending over the entire length of the vessel portion and is formed to have a diameter of about 0.001 mm. 40 and 41, the capillary portion can be configured to have further portions extending along the vertical axis (not shown), where a substantial portion of the capillary portion can be used to provide a reservoir. In another variation of the capillary portion shown in FIG. 42, the capillary vessel portion 378 has a straight profile that extends through the reservoir portion. However, near the opposing end, the capillary vessel may be configured to have a smaller diameter or to have a conical orifice that extends at one or both ends, thereby controlling the resistance in the device.

Each portion 372, 374, 376 and 378 is a master provided in a technique such as photolithography, which allows the construction of capillary portions with precise sub-micron dimensions. Can be molded using). Such devices provide a high level of reproducibility and reliability.

Yet another embodiment includes a capillary portion having a wick member (not shown) disposed inside the capillary inlet. In such embodiments, capillary wicks can be constructed using any number of materials, such as carbon, glass, polypropylene fibers, silver or crimped fiber bundles of metal.

43 and 45 illustrate another embodiment of the invention in which each of the above characteristics or features may be provided. The illustrated shunt 400 provides a body 406 with a channel 408 therebetween for fluid transfer between the head 402, the foot 404, and the opposing distal end. The apparatus may be constructed using any number of constituent materials mentioned above and includes a filter and / or valve assembly 410 that incorporates any of the advanced techniques described in detail above.

A preferred embodiment of the shunt 400 consists of a polymer hydrogel housing 406 and may include a titanium flow-limiting filter 410. The shunt housing 406 is about 1.5 mm in length and has a cylindrical center with flanges 402 and 404 at each end. The proximal or outer flange or head 402 is about 1.4 mm in diameter and has a semi-spherical profile so that it is less noticeable to the eyelids. A remote or internal flange or foot 404 secures the shunt 400 inside the cornea. As described in more detail below, in the first and second variants of the illustrated embodiment, two different central lengths (eg, 0.76 mm and 0.91 mm in the dehydrated state) accommodate various corneal thicknesses. Can be provided for.

The shunt housing 406 has an ophthalmic hydrogel (ie, polyhydroxyethyl methacrylate-methacrylic acid copolymer (polyHEMA-MAA) polyHEMA, copolymers and other expanding materials to have separate hydrated and dehydrated states). Hydrogel). For example, the water content of the hydrated state is about 40 to 45%. The primary material, polyHEMA, is commonly used in vision correction devices, such as soft contact lenses, and is rigid in the dehydrated state. When hydrated, the material expands about 20% (ie, specifically about 10% to about 50%) and is soft and flexible. This property allows the shunt 400 to be implanted in a dehydrated state to take advantage of rigidity, as provided by the manufacturing steps described below, which once changed from a position to a hydrated state after implantation It is flexible and compliant.

Shunt 400 may be prepared by casting a monomer mixture comprising HEMA, methacrylic acid and a dimethacrylate crosslinker into a silicone mold and a heat-curing mixture to form a hydrogel rod. . The rod is then demolded and placed under elevated temperature conditions. Finally, the rod is machined into a shunt packaging geometry, described in more detail below.

The filter / limiter portion, shown to be used with an exemplary embodiment, is a sintered titanium restrictor 410 that allows controlled passage from the front to the tear film. Titanium has long-term stability in implantable devices such as orthopedic devices, pacemakers, arterial stents, and artificial hearts. Exemplary restrictor 410 is made by pressing finely graded titanium powder in a mold and applying heat to sinter each particle together, resulting in a suitable level to effectively reduce the IOP. A porous structure is created with thousands of random labyrinthine fluid pathways that limit the flow rate. Such a process may include a metal injection molding step, in which a round material, such as titanium powder or ceramic, is formed to form a series or a graduation of pore sizes. With binders.

The second function of the restrictor 410 is to help prevent bacterial entry. The same convoluted fluid pathway that also limits the outflow of the aqueous solution from the eye is intended to serve as a barrier to inhibit bacterial ingress. For the titanium restrictor shown to be used in this embodiment, a flow rate in the range of about 1 to 6 μl / min is provided at 10 mm Hg. Another flow rate can be provided using the restrictor / valve arrangement described above.

The shunt 400 is typically implanted with an about 1.6 mm incision in the cornea in the hydrated state. The 1.6 mm incision forms about 1 to 2 mm from the superior limbus. The shunt flange is designed to be implanted in its position up to the flange length, which ensures that the shunt 400 is covered with the upper eyelid and does not affect the patient's field of view. Variety of corneal thickness between patients should be given different sizes of shunts. Specifically, the shunt has a range of about 0.5 mm to about 1.0 mm to accommodate various corneal thicknesses at locations of one or more different center lengths (e.g., flange to flange) from 1 to 2 mm from the top edge. For example, in the range of 0.76 to 0.91 mm in the dehydrated state). This ensures good fit within the cornea and ensures that the extra shunt length does not collide with the iris in the thin cornea.

The foot 404 size is provided to minimize release with the device implanted. The foot size is implanted into the incision with the shunt dehydrated to enable the incision to be sealed after hydration while minimizing long term device release. The foot 404 diameter is about 0.031 inches larger than the shaft of the center of the housing 406 with the foot hydrated to achieve this goal. The hydrated and dehydrated dimensions produce a number of optimized dimensional ratios for the shunt to prevent release, prevent leakage and prevent intrusion, with respect to each other and with respect to the incision size (described in more detail below). Are prepared carefully.

In the dehydrated state, the head 402 is about 0.047 inches in diameter, the foot 404 is about 0.057 inches in diameter, and the expanded body therebetween is about 0.029 inches in diameter. After implantation, the shunt 400 expands about 20% relative to the dimensions of the hydrated state, which hydration seals the 1.6 mm incision. Shunt foot 404 dimensions vary from about 0.057 inches in the dehydrated state to 0.065 inches in the hydrated state to prevent release and leakage. The head 404 increases by about 0.055 inches to prevent intrusion, while the body there between also extends about 0.034 inches in diameter to prevent leakage.

In embodiments of the present application where a 1.6 mm incision is prepared, preferred embodiments of the shunt include from about 1.3 to about 3.0 with the ratio of foot diameter / body diameter (ie, optimized dimension ratio) hydrated, The value is about 1.91. To establish the value of this shunt embodiment, the foot 404 is configured to have a diameter about 0.016 inches larger than the body diameter in the hydrated state.

As mentioned above, in an embodiment of the present application a 1.6 mm (0.063 inch) incision is prepared. Thus, other optimized dimension ratios can be established between the incision size and the foot size in the hydrated and dehydrated states. Preferred embodiments of the shunt include between about 1.0 and about 1.3 with a ratio of incision size / foot diameter (ie, optimized dimensional ratio) hydrated, with a preferred value of 0.063 / 0.057 = 1.10.

Preferred embodiments of the shunt may also include between about 0.75 and about 1.0 with a ratio of incision size / foot diameter hydrated (ie, after implantation), with a preferred value of 0.063 / 0.065 = 0.97. In doing so, the foot diameter is larger than the incision after hydration to prevent release and leakage.

Preferred embodiments of the shunt include between about 1.25 and about 2.0, with the ratio of the incision size / body diameter hydrated (ie after implantation), with a preferred value of 0.063 / 0.034 = 1.85. In doing so, an increase in body diameter after receiving helps to prevent leakage. Another effect of increasing the body diameter is the removal of any sutures required to seal the incision or secure the shunt, which makes the process faster.

Changes in material properties from the dehydrated hard devices to the hydrated soft devices provide numerous advantages. When the device is hard and hard in the dehydrated state, the implantation process is easier and less likely to damage the shunt or remove the filter. With the shunt hydrated, the material is soft and docile. The characteristics of the device, which become soft and flexible with hydration, ensure patient comfort and minimize stress on highly sensitive corneas and eyelids.

While very few exemplary embodiments of the invention have been described above, those skilled in the art will readily appreciate that many variations on the exemplary embodiments are possible without departing significantly from the novel teachings and advantages of the invention. will be. Accordingly, all modifications are intended to be included within the scope of this invention as defined by the following claims.

Claims (79)

A body having a proximal distal end and a remote distal end, said body comprising: a body extending from at least one of anterior or posterior to an outer surface of the eye; A head disposed at the proximal distal end of the body to engage the outer surface of the eye; And  A foot disposed at the remote distal end of the body to engage the interior of at least one of the front or rear; As an ocular implant for fluid communication with the anterior chamber or posterior chamber of the eye, comprising an ocular implant, The ophthalmic implant, wherein the body, the head and the foot are formed and dimensioned to substantially prevent release, intrusion and leakage. The ophthalmic implant of claim 1, wherein at least one of the body, the head, and the foot is comprised of an ocular hydrogel having a dehydrated and hydrated state. The ophthalmic implant of claim 2, wherein the hydrated state is about 10 to 50 percent larger in size than at least one of the body, the head, and the foot than the dehydrated state. The ophthalmic implant of claim 2, wherein the hydrated state is about 23 percent larger in size than at least one of the body, head, and foot than the dehydrated state. The apparatus of claim 1, wherein the foot comprises a circular cross section and the body comprises a circular cross section; And And the ratio between the diameter of the foot circular cross section and the diameter of the body circular cross section is defined as the diameter of the foot circular cross section / the diameter of the body circular cross section and has a value ranging from about 1.3 to about 3.00. The apparatus of claim 1, wherein the foot comprises a circular cross section and the body comprises a circular cross section; And And the ratio between the diameter of the foot circular cross section and the diameter of the body circular cross section is defined as the diameter of the foot circular cross section / the diameter of the body circular cross section and has a value of about 1.9. 3. The body of claim 2, wherein the foot comprises a circular cross section inserted into the incision, wherein the incision has a length; And The ratio between the length of the incision and the diameter of the foot circular cross section is defined as the diameter of the incision length / foot circular cross section, wherein the ophthalmic implant has a value in the range of about 1.0 to 1.3 in the dehydrated state. 3. The body of claim 2, wherein the foot comprises a circular cross section inserted into the incision, wherein the incision has a length; And The ratio between the length of the incision and the diameter of the foot circular cross section is defined as the incision length / diameter of the foot circular cross section, the ophthalmic implant having a value of about 1.10 in the dehydrated state. 3. The body of claim 2, wherein the foot comprises a circular cross section inserted into the incision, wherein the incision has a length; And The ratio between the length of the incision and the diameter of the foot circular cross section is defined as the incision length / diameter of the foot circular cross section, wherein the ophthalmic implant has a value in the range of about 0.75 to 1.0 in the hydrated state. 3. The body of claim 2, wherein the foot comprises a circular cross section inserted into the incision, wherein the incision has a length; And The ratio between the length of the incision and the diameter of the foot circular cross section is defined as the incision length / diameter of the foot circular cross section, the ophthalmic implant having a value of about 0.97 in the hydrated state. 3. The body of claim 2, wherein the body comprises a circular cross section inserted into the incision, the incision having a length; And The ratio between the length of the incision and the diameter of the body circular cross section is defined as the incision length / diameter of the body circular cross section, wherein the ophthalmic implant has a value in the range of about 1.25 to 2.0 in the hydrated state. 3. The body of claim 2, wherein the body comprises a circular cross section inserted into the incision, the incision having a length; And The ratio between the length of the incision and the diameter of the body circular cross section is defined as the incision length / diameter of the body circular cross section, the ophthalmic implant having a value of about 1.85 in the hydrated state. The ophthalmic implant of claim 1, wherein the ophthalmic implant comprises a foot having a diameter in a range from about 0.057 inches to about 0.065 inches. The ophthalmic implant of claim 1, wherein the ophthalmic implant comprises a body having a diameter in a range from about 0.029 inches to about 0.034 inches. The ophthalmic implant of claim 2, wherein the ophthalmic implant has a body length of about 0.030 inches in the dehydrated state and a body length of about 0.035 inches in the hydrated state. The ophthalmic implant of claim 2, wherein the ophthalmic implant has a body length of about 0.036 inches in the dehydrated state and a body length of about 0.042 inches in the hydrated state. The ophthalmic implant of claim 1, wherein the ophthalmic implant comprises a body length in a range from about 0.0196 inches to about 0.0393. The implant of claim 2, wherein the ophthalmic implant is inserted in the dehydrated state, the dehydrated state providing the implant in a substantially rigid form; And The ophthalmic implant is hydrated after insertion, wherein the hydrated state provides the implant in a soft and flexible form. The apparatus of claim 1, wherein the head comprises a circular cross section and the body comprises a circular cross section; And The diameter of the circular cross section of the head and the diameter of the main body circular cross section are defined as the diameter of the circular cross section of the head / the diameter of the main body circular cross section and have a value of about 1.62. 3. The ophthalmic implant of claim 2, wherein the ophthalmic implant comprises a head diameter of about 0.047 in the dehydrated state and a foot diameter of about 0.057 inches in the dehydrated state; And The ophthalmic implant comprises an ophthalmic implant having a head diameter of about 0.055 inches in a hydrated state and a foot diameter of about 0.065 inches in a hydrated state. The ophthalmic implant of claim 1, wherein the head comprises at least one of a contoured surface, an inclined surface and a flat surface. The apparatus of claim 1, further comprising: the head disposed to have a first angle with respect to the body; And the foot disposed substantially parallel to the head. 23. The ophthalmic implant of claim 22, wherein the ophthalmic implant is formed such that the ophthalmic implant is inserted into a specific site comprising at least one of a transparent corneal insertion site and a transscleral insertion site. 2. A body according to claim 1, wherein the main body having a proximal portion and a remote portion is arranged so as to have a second angle with respect to the remote portion; The head is arranged to have a third angle with respect to the proximal portion of the body; And And the foot is disposed to have a fourth angle with respect to the remote portion of the body. 25. The ophthalmic implant of claim 24, wherein the second, third and fourth angles are formed such that the implant is inserted into a specific site comprising at least one of a transparent corneal insertion site and a transscleral insertion site. . The method of claim 1, wherein at least one of the body, the head, and the foot comprises silicone, polymethylmethacrylate, poly 2-hydroxyethyl methacrylate, hyaluronic acid, silicone / hydrogel An ophthalmic implant comprising one or more of a combination, a silicone acrylic combination, a fluorosilicone acrylate, ceramic, coral and stainless steel. The ophthalmic implant of claim 1, wherein at least one of the body, the head, and the foot is coated with an antimicrobial agent. The ophthalmic implant of claim 27, wherein the antimicrobial agent comprises at least one of an ionic metal compound, an antimicrobial polymer, an organic compound, and an inorganic compound. The method of claim 1, wherein at least one of the body, the head, and the foot is selected from a surgical adhesive, a fibrin-based glue, a marine adhesive protein, and a synthetic polymer adhesive. An ophthalmic implant comprising at least one. The ophthalmic implant of claim 1, wherein at least one of the body, the head, and the foot is provided with at least one of a rough surface, a protrusion, and a mechanical thread. The ophthalmic implant of claim 1, wherein the body comprises a substantially noncircular cross section. The method of claim 1, wherein the foot is flexible against deflect, provides a reduced outer diameter during insertion into the incision, and returns to the untwisted position after insertion to secure the foot within the incision. An ophthalmic implant characterized by. 2. The foot of claim 1 wherein the foot is substantially rectangular, and is rotatable between a first position that is substantially parallel to the incision and a second position that is substantially perpendicular to the incision. An ophthalmic implant, characterized in that it is fixed in the incision. The method of claim 1, wherein the head is provided with an access port for injecting, injecting, injecting and injecting the predetermined substance into at least one of the front and the rear. Ophthalmic implants. 35. The ophthalmic implant of claim 34, wherein the entry portion comprises at least one of a substantially circular opening and a slit opening. 35. The method of claim 34, wherein the agent is a neuroprotective agent immune response modifiers, neuroprotectants, corticosteroids, angiostatic steroids, anti-glaucoma agents Ophthalmic, characterized in that it comprises one or more of: angiogentic compounds, anti-biotics, anti-bacterial agents, antiviral agents, anticancer agents and anti-inflammatory agents Implants. The ophthalmic implant of claim 1, wherein at least one of the body, the head, and the foot comprises a porous surface containing the predetermined material for injecting into at least one of anterior and posterior. The ophthalmic implant of claim 1, wherein at least one of the body, the head, and the foot comprises a porous material containing the predetermined material for injecting into at least one of anterior and posterior. The ophthalmic implant of claim 1, wherein the body comprises a substantially porous material to provide transfer between at least one of anterior and posterior and the outer surface of the eye. The ophthalmic implant of claim 1, wherein the body comprises one or more channels to provide for transfer between at least one of anterior and posterior and the outer surface of the eye. 41. The ophthalmic implant of claim 40, wherein said head is provided with a membrane substantially covering said channel. 43. The ophthalmic implant of claim 41, wherein the membrane is comprised of a porous hydrogel material. 42. The ophthalmic implant of claim 41, wherein the head is configured such that an epithelium membrane grows to substantially cover the channel. 41. The ophthalmic implant of claim 40 further comprising a flow restrictor disposed within the channel. 45. The ophthalmic implant of claim 44, wherein the flow restrictor comprises at least one of an antimicrobial element, a micro-device element and a filter element. 46. The method of claim 45, wherein the antimicrobial element is an ionic metal compound, an antimicrobial polymer, a bacteria resistant metal, a bacteria resistant sphere, a silver fiber member, a silver plate member, an antimicrobial filter, 2 Antimicrobial organic compounds including atomic powders, cast porous matrix, alkyl trypsin, biguanide, triclosan and chlorhexidine and antimicrobial including quaternary ammonium salts and metal oxides An ophthalmic implant comprising at least one of microbial inorganic compounds. 47. The ophthalmic implant of claim 46, wherein the bacterial resistant spheres comprise free soluble spheres impregnated with silver ions. 46. The ophthalmic implant of claim 45, wherein the micro-device element comprises a micro-mechanical pump. 46. The ophthalmic implant of claim 45, wherein the filter element comprises at least one of a hollow fiber filter, a capillary filter, a hydrogel filter, and a porous filter. 50. The ophthalmic implant of claim 49, wherein said filter element further comprises an antimicrobial material therein. 50. The ophthalmic implant of claim 49, wherein the filter element is provided to allow certain material to be injected into one or more of the front and rear. 52. The method of claim 51, wherein the predetermined agent is one or more of an immune response modulator, a neuroprotective agent, a corticosteroid, a hemostatic steroid, an antiglaucoma agent, an antihemostatic compound, an antibiotic, an antibacterial agent, an antiviral agent, an anticancer agent, an anticancer agent, and an anti-inflammatory agent. An ophthalmic implant comprising a. 50. The ophthalmic implant of claim 49, wherein the filter element comprises a plurality of the filters arranged in a predetermined order. 46. The filter element of claim 45, wherein the filter element comprises silicone, polymethacrylate, poly 2-hydroxyethylmethacrylate, hyaluronic acid, silicone / hydrogel combinations, combinations of silicone acrylics, fluorosilicone acrylates, ceramics An ophthalmic implant comprising at least one of coral, titanium and stainless steel. The filter of claim 49 wherein the hollow fiber filter is: A base having one or more fluid delivery openings; And An ophthalmic implant comprising one or more fibers extending from the fluid delivery opening. 59. The fiber of claim 55 wherein the fiber comprises: a fiber body having a substantially hollow center closed at one end of the fiber body and open at an opposite end of the body; And the fiber body comprises a substantially porous material providing fluid transfer between the outer surface of the fiber body and the hollow center. 59. The ophthalmic implant of claim 56, wherein the porous material has a pore size gradient between the outer surface of the fiber body and the hollow center. 50. The ophthalmic implant of claim 49, wherein the capillary filter comprises a plurality of capillary tubes extending between the remote and proximal distal ends of the capillary filter. 45. The ophthalmic implant of claim 44, wherein said flow restrictor is integrated with said head. 45. The ophthalmic implant of claim 44, wherein said flow restriction device is integrated with said body. 45. The ophthalmic implant of claim 44, wherein said flow restrictor is replaceable. 41. The ophthalmic implant of claim 40, further comprising a valve disposed within the channel. 63. The valve of claim 62, wherein the valve includes a flap portion, a poppit valve, a Vemay valve, a duck-bill valve, an umbrella valve, a pressure cracking valve. an ophthalmic implant comprising a valve and a dome-over valve. A method of placing an ophthalmic implant in fluid communication with the front or back of the eye, the method comprising: Making an incision at the incision site; And Inserting an ophthalmic hydrogel implant in a dehydrated state at the incision site, The implant is: A body having first and second distal ends, the body having a hydrated and dehydrated state; A head disposed at the first distal end of the body to engage the outer surface of the eye (the head has a hydrated and dehydrated state); A foot disposed on the second distal end of the body to engage the interior of one or more of the front and rear of the eye, the foot having a hydrated and dehydrated state, The body, the head and the foot are characterized in substantially preventing release of the implant from the insertion site and leakage from the insertion site. 65. The method of claim 64, wherein the hydrated state is about 10 to about 50 percent greater in dimension than at least one of the body, the head, and the foot. 65. The diameter of the foot circular cross section and the diameter of the body circular cross section of claim 64, defined as the diameter of the foot circular cross section / the diameter of the body circular cross section, having a value ranging from about 1.3 to about 3.00 in the hydrated state. And providing a ratio between the ophthalmic implants. 65. The method of claim 64, defined by the length of the incision length / foot circular cross section to provide a ratio between the length of the incision and the diameter of the foot having a value ranging from about 0.75 to about 1.0 in the hydrated state. Method for arranging an ophthalmic implant further comprising a. 65. The method of claim 64, defined as the incision length / diameter of the circular section of the body to provide a ratio between the length of the incision and the diameter of the body having a value ranging from about 1.25 to about 2.0 in the hydrated state. Method for placing an ophthalmic implant further comprising a. 65. The ophthalmic implant of claim 64, wherein the shapes and dimensions of the body, the head and the foot eliminate the need for suture when inserted into the incision site in a dehydrated state. How to place. Processing the shunt from one or more ophthalmic hydrogels in a dehydrated state to provide a body comprising a proximal end and a remote end, a head disposed at the proximal end of the body, and a foot disposed at the remote end of the body. Including a step; And Wherein the body, the head and the foot are shaped and dimensioned to substantially prevent release, injection and leakage when changed from the dehydrated state to the hydrated state. 71. The corneal implant of claim 70, further comprising processing the shunt comprising a body having one or more channels to provide transfer between at least one of the anterior and posterior and the outer surface of the eye. How to prepare. 71. The method of claim 70, further comprising disposing one or more antimicrobial elements, micro-device elements, and filter elements inside the channel. Casting a monomer mixture comprising at least one of HEMA, methacrylic acid and a dimethacrylate crosslinker to a mold; Curing the monomer mixture to form a hydrogel rod; Conditioning the rod; And Processing the rod into a shunt package to provide a body having a proximal end and a remote end, a head disposed at the proximal end of the body, and a foot disposed at the remote end of the body, Wherein said body, said head, and said foot are shaped and dimensioned to substantially prevent release, injection, and leakage. 74. The method of claim 73, wherein the mold comprises a silicone mold. 74. The method of claim 73, wherein said curing step comprises at least one heat-curing step. 74. The method of claim 73, further comprising demoulding the rod after the curing step. 74. The method of claim 73, wherein the polishing step comprises polishing the rod under elevated temperature. 74. The process of claim 73 wherein the processing step is: Fabricating the hydrogel housing of the corneal implant, characterized by processing the shunt to include one or more channels inside the body to provide transfer between one or more of the anterior and posterior and the outer surface of the eye. Way. 79. The method of claim 78, further comprising disposing one or more antimicrobial elements, micro-device elements, and filter elements within the channel.

Images