# Patent

## Title
Internal shunt and method for treating glaucoma

## Abstract

A surgical technique and device wherein an indwelling tube is placed in the eye of a patient having glaucoma. The tube diverts aqueous humor from the anterior chamber to the suprachoroidal space from which it is removed by blood flowing in the choroidal and uveal tissues. This decreases the intraocular pressure.

## Background
RELATED APPLICATIONS
This application is a continuation of U.S. patent application Ser. No. 11/509,327, filed Aug. 23, 2006, entitled “Internal shunt and method for treating glaucoma,” which is a continuation of U.S. patent application Ser. No. 10/429,336, filed May 5, 2003 now abandoned. The subject matter of each of the above-noted applications is incorporated by reference in their entirety by reference thereto.


FIELD OF THE INVENTION
This invention pertains to a surgical treatment for glaucoma and, more particularly, to a new method and apparatus for surgically alleviating the intraocular pressure causing the glaucoma condition.
BACKGROUND
Glaucoma is an eye condition in which the hydrostatic pressure within the eye is abnormally high, thereby resulting in damage to the optic nerve. There are many treatments for the glaucoma condition that involve lowering the intraocular pressure, either by means of medication or surgery.
Medicinal treatments either decrease the rate at which aqueous humor is pumped into the eye or improve the outflow of aqueous humor from the eye.
There are three primary surgical methods for treating glaucoma. Presently, none of them are a complete answer to the problem:

    
    
        a) Cyclodestructive procedures damage the ciliary body of the eye and decrease the rate of aqueous humor production. The main problem is the extremely fine dividing line between too little and too much treatment. This treatment often does not work, or it works too well. When the surgery works too well, a hypotonous eye may develop in which the pressure is too low for normal ocular function and health.
        b) Laser therapy of the trabecular meshwork is used to decrease the resistance of outflow of aqueous humor into the Canal of Schlemm. The main problem with this procedure is that it only provides relief for about five years. Re-treatment is often unsuccessful because it may cause too much scarring of the outflow channels. Thus, this procedure can do more harm than good.
        c) Shunting of aqueous humor from the anterior chamber through the sclera to outside of the confines of the eye is the most common surgical procedure. Among the shunting procedures, the often-performed trabeculectomy is a type of filtering method. It allows aqueous humor to “filter” out of the eye. A channel is created from the anterior chamber under a scleral flap to the episcleral space. The main problem with this procedure is that the outcome depends on the individual healing properties of the eye in the post-operative period. Trabeculectomy is often much less successful in highly pigmented eyes and eyes with previous surgery, rubeosis, or chronic uveitis. To overcome this problem, several shunts have been devised to carry aqueous humor from the anterior chamber to the episcleral space. Scarring often occurs surrounding the exterior end when shunts are used. This renders the outcome unpredictable.
    
    


Another problem with these types of surgical procedures is that the globe is left with a transcleral fistula. The fistula renders the eye susceptible to the ingress of organisms and intraocular infection. This condition is known as endophthalmitis and can be devastating to the eye, since the eye is not naturally designed to defend against this type of onslaught.
The invention seeks to provide a surgical treatment and apparatus that will overcome the many problems associated with present-day surgical procedures.
The current invention provides an indwelling shunt that diverts aqueous humor from the anterior chamber to the blood flowing in the choroidal and uveal tissues. This decreases the intraocular pressure of the glaucomatous eye. The indwelling shunt maintains the area of exposure of aqueous humor with the uvea by physically preventing scarring of the surrounding tissues. The method utilizes the normally occurring 25 mm Hg driving force of the protein colloid osmotic pressure of the blood to maximize the flow of aqueous humor out of the eye (Yablonski, M. E., J of Glaucoma, February 2003, 12(1):90-92).
One of the many problems that this inventive procedure overcomes is the normally low outflow of aqueous humor into the uveal blood caused by the normally low hydraulic permeability between the aqueous humor of the anterior chamber and the uveal blood vessels (Yablonski, ibid.). The internal tube shunt of this invention, however, greatly increases the hydraulic permeability between the aqueous humor and the uveal blood vessels, thus greatly increasing the magnitude of the outflow via this route.
The present invention overcomes the two main objections of most of the current surgical approaches: (a) it requires no permanent transcleral route for the egress of aqueous humor from the eye, and (b) the success of the procedure is not as dependent on the individual healing properties of the eye as it is in other procedures. Therefore, the inventive technique not only works in younger eyes, but it also works in eyes of darkly pigmented individuals, and eyes of patients who have had previous surgery. In addition, the inventive procedure leaves no transcleral route in the eye, thus decreasing the susceptibility to endophthalmitis.
In an article by Stegmann (1990), a procedure is described wherein a non-penetrating deep sclerectomy is performed. The procedure was called “viscocanalostomy” because a viscoelastic substance was injected into the cut ends of the canal of Schlemm after the canal was exposed. Like the present technique, Stegmann first created a thin scleral flap, then created a deep sclerectomy by removing the deep sclera, leaving only a thin layer of sclera of 50 to 100 microns in thickness overlying the choroidal tissue beneath.
It should be observed that Stegmann sutured the overlying scleral flap very tightly, thereby eliminating a final transcleral route for aqueous humor drainage. This implied that the intended mechanism for aqueous humor egress was an intraocular shunt. The mechanism of action of the procedure was proposed by Stegmann to be the access of aqueous humor to the newly dilated canal of Schlemm, from which it flowed from the eye by the usual outflow routes. However, if this were the case, the outflow facility of the eyes should be increased, as measured by tonography. No studies have shown an increase in outflow facility after the viscocanalostomy is performed, despite a marked decrease in intraocular pressure.
Another related technique to that of the current invention is the procedure that sutures a collagen implant beneath the scleral flap into the bed of the deep sclerectomy (M. E. Karlen, E. Sanchez, C. C. Schnyder, M. Sickenberg, and A. Mermoud, Deep sclerectomy with collagen implant: medium term results, Br J Ophthalmol, January 1999, 83(1):6-11). The method provides a non-penetrating deep sclerectomy wherein a collagen implant is placed between the overlying scleral flap and the underlying suprachoroidal space. No dilation of the canal of Schlemm is performed. No flow of aqueous humor into the uveal blood is suggested, and only two scleral flap sutures are used, which renders the scleral flap permeable to transcleral flow and creates a transcleral fistula.
In U.S. Pat. No. 6,383,219, issued on May 7, 2002 to Telandro et al., a related non-penetrating deep sclerectomy is illustrated. The method uses an implant made of a cross-linked hydraluronic acid material, which is shaped like a polyhedron having at least five faces. The material is placed between the overlying scleral flap and the underlying suprachoroidal scleral bed. Unlike the current inventive method, this procedure does not propose that the aqueous humor flows mainly into the adjacent uveal blood in response to its protein colloid osmotic pressure. The use of only two sutures in the overlying scleral flap renders this flap permeable to transcleral flow, creating a transcleral fistula.
The stated mechanism for relief in Telandro et al. is the high water content that acts like a wick, i.e., it transports the ocular fluids by capillary action. No mention is made of flow of aqueous humor into the uveal blood, and it is implied that the final destination of the flow of aqueous humor is across the overlying scleral flap into the episcleral space. This method is similar to a conventional trabeculectomy and other filtering procedures.
Some internal shunts have previously been proposed. In U.S. Pat. No. 6,450,984, issued to Lynch and Brown on Sep. 17, 2002, a shunt is illustrated that shunts fluid from the anterior chamber. The shunt is placed under a scleral flap and into the open ends of the canal of Schlemm. This method requires normal drainage of aqueous humor from the canal of Schlemm into the episcleral veins. Since in open angle glaucoma, which is the most common type of glaucoma, flow through the canal of Schlemm is impaired, this technique appears flawed. To the best of knowledge and belief, no reports exist in the literature depicting the successful implementation of this technique.
In U.S. Pat. No. 5,601,094, issued on Feb. 11, 1997 to Reiss, a shunt is described which causes flow of aqueous humor from the anterior chamber to the suprachoroidal space. Unlike the present invention, however, the shunt is exteriorized before it enters the suprachoroidal space. This renders the eye susceptible to endopthalmitis. To the best of knowledge and belief, there have been no successful reports for this technique in the literature.
In U.S. Pat. No. 4,521,210, issued on Jun. 4, 1985 to Wong, a shunt is illustrated that extends from the anterior chamber to the suprachoroidal space. The shunt is designed to create a permanent cyclodialysis cleft and shunt aqueous fluid to the suprachoroidal space from the anterior chamber. The suprachoroidal space is surgically entered and the ciliary body disinserted from the scleral spur. To the best of knowledge and belief, there have not been any reports in the literature of the success of this technique.
SUMMARY
In accordance with the present invention, a surgical technique and apparatus are illustrated for alleviating the glaucoma condition. The current invention provides an indwelling shunt that diverts aqueous humor from the anterior chamber to the blood flowing in the choroidal and uveal tissues. This decreases the intra-ocular pressure. The indwelling shunt maintains the area of exposure of aqueous humor with the uvea by physically preventing scarring of the surrounding tissues. The method utilizes the 25 mm Hg driving force of the protein colloidal osmotic pressure of the blood to maximize the flow.
One method illustrated in FIGS. 1, 3, and 4 comprises the initial step of folding back a one-third scleral thickness scleral flap hinged at the peripheral cornea. A small cavity is generated, extending into the peripheral cornea, by the removal of deep scleral tissue (known as a deep sclerectomy), leaving a very thin, approximately 50 micron in thickness scleral bed (FIG. 4) over the underlying choroid. The suprachoroidal space is entered at the lateral edges of the scleral bed by cutting directly or at a laterally slanted angle. The shunt, which can comprise a precut tube with polished edges, is placed one end permanently into the suprachoroidal space and the other in the scleral lake and is sutured into the overlying sclera. The precut tube can be delivered with a suture in place for ease of deployment. Other examples of structures that can function as a shunt in addition to a hollow tube include a solid section of material grooved to carry aqueous humor, or a structure of open cell foam or other porous material, and similar structures in each case made from biologically compatible materials.
After suturing, one end of the tube is in the suprachoroidal space and the other is in the scleral lake created by the deep sclerectomy. Then a trabeculectomy specimen is created, plus a peripheral iridectomy, as in a standard trabeculectomy. The scleral flap is turned back to its normal position resting on the deep scleral shelf and is sutured to the adjacent sclera with six to ten interrupted sutures to yield a tight closure. The shunt can be fabricated from silicone or other biocompatible materials. One or two such tubes can be placed on each lateral side of the deep sclerectomy. These tubes not only shunt aqueous humor from the scleral lake into the suprachoroidal space, they also help maintain the volume of the scleral lake by acting as a physical barrier between the overlying scleral flap and the underlying scleral bed.
In another version of this procedure (FIG. 2), the scleral lake is smaller and is separated from the anterior chamber by an approximately 3 mm wide layer of full thickness sclera. A tunnel is created with a 23 gauge needle and one end of the tube is inserted through the tunnel into the anterior chamber. The other end of the tube is placed through an incision, at the posterior edge of the scleral bed, into the posterior suprachoroidal space where it is sutured to the overlying sclera. Then the scleral flap is tightly sutured back into place. Other examples of structures that can function as a shunt in addition to a hollow tube include a solid section of material grooved to carry aqueous humor, or a structure of open cell foam or other porous material, and similar structures in each case made from biologically compatible materials.
It is an object of this invention to provide an improved surgical technique and apparatus for treating glaucoma.
It is another object of the present invention to provide both a surgical method and an apparatus that utilizes the uveal blood vessels to drain aqueous humor from the anterior chamber of the eye to decrease intra-ocular pressure in the treatment of glaucoma.



BRIEF DESCRIPTION OF THE DRAWINGS
A complete understanding of the present invention may be obtained by reference to the accompanying drawings, when considered in conjunction with the subsequent detailed description, in which:
FIG. 1 illustrates a top, three-dimensional, perspective, enlarged view of a portion of the eye, shown in partial cut-away;
FIG. 2 depicts a top, three-dimensional perspective view of the second type of internal tube shunt procedure, enlarged view of the portion of the eye, shown in partial cutaway;
FIG. 3 shows a top view of the portion of the eye illustrated in FIG. 1; and
FIG. 4 illustrates a sectional view of the portion of the eye depicted in FIGS. 1 and 3.



For purposes of brevity and clarity, like components and elements of the apparatus of this invention will bear the same designations or numbering throughout the FIGURES.
DETAILED DESCRIPTION
Generally speaking, a surgical technique and apparatus is described wherein an indwelling shunt is placed in the eye of patients having glaucoma. The shunt diverts aqueous humor from the anterior chamber to the suprachoroidal space from which it is removed by the blood flowing in the choroidal and uveal tissues. This decreases the intra-ocular pressure. The indwelling shunt maintains the area of exposure of aqueous humor with the uvea by physically preventing scarring of the surrounding tissues. The method utilizes the 25 mm Hg driving force of the protein colloidal osmotic pressure of the blood to drive aqueous humor into the blood.
In FIGS. 1 through 4, a portion of an eye is shown being surgically prepared with a hollow tube (indwelling shunt) 1 for the treatment of glaucoma. The hollow tube 1 has an interior open space 2 in which fluid (not shown) is transferred. The tube 1 diverts aqueous humor from the scleral lake 8 (FIG. 4) to the suprachoroidal space 12, as best observed with reference to FIGS. 1 and 3. This shunting of the aqueous humor decreases the intra-ocular pressure. The indwelling shunt 1 maintains the area of exposure of aqueous humor with the uvea by physically preventing scarring of the surrounding tissues. The method utilizes the 25 mm Hg driving force of the protein colloidal osmotic pressure of the blood of the uveal blood vessels 14 to maximize the flow (Yablonski, ibid.).
The method comprises the initial step of folding back the scleral flap 4 of the eye (FIG. 1). A small cavity, the deep scleral lake 8, is generated by the removal of tissue in the sclera 7. The suprachoroidal space 12, a normally occurring potential space, is entered by cutting directly, or at a slanted angle through the scleral bed 9. The shunt 1, which can comprise a precut tube with polished edges, is then inserted into the suprachoroidal space 12 and sutured by sutures 15 to the overlying sclera 7 therein, as best seen in FIGS. 1 and 2. The precut tube 1 can also contain sutures fabricated in place for ease of deployment.
After suturing the tube 1 in place, a trabeculectomy specimen 5 may be removed, thus creating a direct communication to the anterior chamber 21 (best seen in FIG. 4). A peripheral iridectomy 6 may be created in the iris 11. The scleral flap 4 is then replaced, resting on the deep scleral shelf 3 where it is tightly sutured to the adjacent sclera 7. The shunt 1 can be fabricated from silicone or other biocompatible materials. It can be seen, therefore, that this technique does not create a permanent cyclodialysis cleft and does not disinsert the ciliary body from the scleral spur.
Referring to FIG. 1, the internal tube shunt 1 of the present invention is inserted and sutured between the suprachoroidal space 12 and the deep scleral lake 8 generated by the surgical forming of a scleral flap 4, and a deep sclerectomy starting 4.5 mm from the limbus and extending into the peripheral cornea 10. Since the deep sclerectomy is about 1 mm smaller than the dimensions of the scleral flap 4, a deep scleral ledge 3 approximately 0.5 mm in width is created on the lateral and posterior aspect of the deep scleral lake 8.
Referring now to FIG. 2, the shunt 1 of the present invention is illustrated passing from the anterior chamber 21 through the adjacent sclera 7, through a posterior deep scleral lake 8, and into the posterior suprachoroidal space 12 where it is sutured to the overlying sclera 7. The deep scleral lake 8 is generated by forming a scleral flap 4 and deep sclerectomy similar to that of FIG. 1 but with an anterior end 3 mm posterior to the cornea 10.
Referring now to FIG. 3, the shunt 1 of the present invention is inserted and laterally sutured into the suprachoroidal space 12 on each side of the deep scleral lake 8 generated by forming a scleral flap 4 and a deep sclerectomy, with the scleral flap 4 sutured back into place over the ends of the tube shunts 1. Also shown are the peripheral iridectomy 6 and the trabeculectomy site 5.
Referring to FIG. 4, the shunt of this invention is seen in the deep scleral lake 8 between the overlying scleral flap 4 and the underlying scleral bed 9. Also shown are the trabeculectomy site 5 and the peripheral iridectomy 6.
FIGS. 1, 3, and 4 show one possible incorporation of the invention where aqueous humor gains access to the shunt 1 via a trabeculectomy 5 between the anterior chamber 21 and the deep scleral lake 8 where one end of the tube 1 lies. From the deep scleral lake 8, aqueous humor is shunted via the tube 1 to the suprachoroidal space 12.
FIG. 2 shows another possible incorporation of the invention in which aqueous humor is shunted directly by a tube 1 that passes from the anterior chamber 21 through the sclera 7 between the anterior chamber 21 and the deep sclerectomy space, and into the suprachoroidal space 12 at the posterior aspect of the deep sclerectomy where it is sutured to the overlying sclera 7.
In this version, the deep sclerectomy is smaller than the deep scleral lake 8 shown in FIGS. 1 and 4. Unlike the version in FIGS. 1 and 4 where the deep scleral lake 8 serves as the pool of aqueous humor which flows into the tube 1, in the version of FIG. 2, the deep sclerectomy serves only to allow the surgeon access for insertion of the tube 1 into the anterior chamber 21, anteriorly, and the suprachoroidal space 12, posteriorly. After the tube 1 is in place, the scleral flap 4 is sutured to the adjacent sclera 7 and no permanent deep scleral lake 8 need persist.
Since other modifications and changes varied to fit particular operating requirements and environments will be apparent to those skilled in the art, the invention is not considered limited to the examples chosen for purposes of disclosure and covers all changes and modifications which do not constitute departures from the true spirit and scope of this invention.
Having thus described the invention, what is desired to be protected by Letters Patent is presented in the subsequently appended claims.

## Claims

1. A method of treating glaucoma, comprising:
providing an elongated tube comprising at least one inflow port, at least one outflow port and an internal fluid passageway communicating between the at least one inflow port and at least one outflow port;
creating a tunnel in eye tissue;
inserting the tube through the tunnel;
positioning the tube entirely within an interior of the eye such that the at least one inflow port of the fluid passageway is positioned in and communicates with the anterior chamber and the at least one outflow port of the fluid passageway communicates with the suprachoroidal space;
leaving only the tube inside the eye; and
diverting aqueous humor through the fluid passageway from the anterior chamber toward the suprachoroidal space.

2. A method as in claim 1, wherein implanting the tube entirely within an interior of the eye comprises implanting the tube so that the tube is positioned radially inward of an outer surface of the sclera.

3. A method as in claim 1, wherein implanting the tube entirely within an interior of the eye comprises implanting the tube so that at least one inflow port is positioned in the anterior chamber posterior of an inner surface of the cornea.

4. The method of claim 1, wherein the tube comprises a rounded, outer surface that contacts a portion of the sclera.

5. The method of claim 1, further comprising attaching a retaining structure to an end of the tube.

6. The method of claim 5, wherein the retaining structure comprises a suture attached to a distal end of the shunt.

7. The method of claim 1, further comprising cutting the tube prior to implantation.

8. A method of treating glaucoma, comprising:
providing a tube having an internal lumen, a first opening for fluid to flow into the internal lumen, and a second opening for fluid to flow out of the internal lumen;
creating a tunnel in eye tissue;
inserting the tube through the tunnel;
positioning the tube inside an eye so that the first opening is inside the anterior chamber and the second opening communicates with the suprachoroidal space;
leaving only the tube inside the eye; and
causing fluid to flow from the anterior chamber into the internal lumen through the first opening and out of the internal lumen toward the suprachoroidal space through the second opening.

9. A method as in claim 8, wherein positioning the tube inside an eye comprises implanting the tube so that the tube is positioned radially inward of an outer surface of the sclera.

10. A method as in claim 8, wherein implanting the tube inside an eye comprises implanting the tube so that the first opening is positioned in the anterior chamber posterior of an inner surface of the cornea.

11. The method of claim 8, wherein the tube comprises a rounded, outer surface that contacts a portion of the sclera.

12. The method of claim 1, wherein the tunnel is created using a needle.

13. The method of claim 1, wherein the outflow port is positioned in the suprachoroidal space.

14. The method of claim 1, wherein the tube is cylindrical.

15. The method of claim 1, wherein aqueous humor flows directly into the suprachoroidal space via the fluid passageway.

16. The method of claim 8, wherein the tunnel is created using a needle.

17. The method of claim 8, wherein the second opening is positioned in the suprachoroidal space.

18. The method of claim 8, wherein the tube is cylindrical.

19. The method of claim 1, wherein aqueous humor flows directly into the suprachoroidal space via the internal lumen.