SYSTEM AND METHOD FOR TREATING AN OCULAR DISORDER

Abstract

Surgical methods and related medical devices for treating ocular disorders are disclosed. Some methods relate to delivering an implant within an eye, and involve providing an elongate guide device, such as, a flexible guide member or a guide wire. A distal end of the guide device can be advanced into an anterior chamber of an eye, or through at least a portion of a site of resistance along a physiologic outflow pathway of the eye, or from an anterior chamber of the eye to a location proximate a physiologic outflow pathway of the eye. The implant is advanced along the guide device toward the guide device distal end, and is positioned to conduct aqueous humor between the anterior chamber and the physiologic outflow pathway.

Claims

1. (canceled)

2. A method of treating glaucoma comprising: forming an incision in a cornea of an eye; inserting a delivery applicator through the incision in the cornea and across at least a portion of an anterior chamber of the eye in an ab interno manner under gonioscopic guidance, the delivery applicator comprising an elongate member having a distal end portion configured to retain an implant therein, the distal end portion comprising a cutting member configured to penetrate a trabecular meshwork of the eye for receipt of the implant in Schlemm's canal; penetrating the trabecular meshwork using the cutting member of the delivery applicator; guiding the implant into Schlemm's canal such that a distal section of the implant extends along a length of Schlemm's canal and such that a proximal end of the implant is positioned in the anterior chamber; and removing the delivery applicator from the eye, wherein the implant comprises flexible material that is at curved along its distal section, wherein the implant is sized and shaped so as to slide in place in Schlemm's canal without undue suturing, and wherein the implant has at least one opening positioned along its distal section.

3. The method of claim 2, wherein the incision is a self-sealing incision.

4. The method of claim 2, wherein implant is made of a biocompatible, elastic material.

5. The method of claim 2, wherein the implant has a generally tubular shape.

6. The method of claim 2, wherein the implant comprises a one-way valve.

7. The method of claim 2, wherein the implant comprises one or more retention features.

8. A method of treating glaucoma comprising: forming an incision in a cornea of an eye; inserting a delivery applicator through the incision in the cornea and across at least a portion of an anterior chamber of the eye, the delivery applicator comprising an elongate member having a distal end portion configured to retain an elongated seton therein, the delivery applicator being sharpened; penetrating a trabecular meshwork of the eye using the delivery applicator; guiding the elongated seton into Schlemm's canal of the eye such that a distal section of the elongated seton extends along a length of Schlemm's canal and such that an inlet section of the elongated seton is positioned in the anterior chamber; and removing the delivery applicator from the eye, wherein the distal section of the elongated seton is curved at an angle between 30 degrees and 150 degrees with reference to the inlet section of the elongated seton, and wherein the elongated seton has at least one opening positioned along its distal section.

9. The method of claim 8, wherein the incision is a self-sealing incision.

10. The method of claim 8, wherein seton is made of a biocompatible, elastic material.

11. The method of claim 8, wherein the seton has a generally tubular shape.

12. The method of claim 8, wherein the seton comprises a one-way valve.

13. The method of claim 8, wherein the seton comprises one or more retention features.

14. The method of claim 8, wherein the seton comprises an opening along its distal section.

15. A method of treating glaucoma comprising: forming an incision in a cornea of an eye; inserting a delivery applicator through the incision in the cornea and across at least a portion of an anterior chamber of the eye in an ab interno manner under gonioscopic guidance, the delivery applicator comprising an elongate member having a distal end portion configured to retain an implant therein, the distal end portion comprising a cutting member configured to form an opening in the trabecular meshwork of the eye for receipt of the implant; forming an opening in a trabecular meshwork using the cutting member of the delivery applicator; delivering the implant out of the elongate member of the delivery applicator such that a distal section of the implant is positioned in Schlemm's canal of the eye so as to extend along a length of Schlemm's canal and such that a proximal end of the implant is positioned in the anterior chamber; and removing the delivery applicator from the eye, wherein the implant is made of relatively soft material that is at least somewhat curved at its distal section to fit into and along Schlemm's canal, wherein the implant is sized and shaped so as to stabilize the implant in place without undue suturing, and wherein the implant has at least one opening positioned along its distal section.

16. The method of claim 15, wherein the incision is a self-sealing incision.

17. The method of claim 15, wherein implant is made of a biocompatible, elastic material.

18. The method of claim 15, wherein the implant has a generally tubular shape.

19. The method of claim 15, wherein the implant comprises a one-way valve.

20. The method of claim 15, wherein the implant comprises one or more retention features.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Additional objects and features of the present invention will become more apparent and the invention itself will be best understood from the following Detailed Description of Exemplary Embodiments, when read with reference to the accompanying drawings.

[0039] FIG. 1 is a sectional view of an eye for illustration purposes.

[0040] FIG. 2 is a close-up sectional view, showing the anatomical diagram of trabecular meshwork and the anterior chamber of the eye.

[0041] FIG. 3 is an embodiment of the seton implant constructed according to the principles of the invention.

[0042] FIG. 4 is a top cross-sectional view of section 4-4 of FIG. 3.

[0043] FIG. 5 is another embodiment of the seton implant constructed in accordance with the principles of the invention.

[0044] FIG. 6 is a perspective view illustrating the seton implant of the present invention positioned within the tissue of an eye.

[0045] FIG. 7 is an alternate exemplary method for placing a seton implant at the implant site.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0046] Referring to FIGS. 1 to 7, what is shown is a method for the treatment of glaucoma by trabecular bypass surgery. In particular, a seton implant is used to bypass diseased trabecular meshwork at the level of trabecular meshwork to use or restore existing outflow pathways and methods thereof.

[0047] For background illustration purposes, FIG. 1 shows a sectional view of an eye 10, while FIG. 2 shows a close-up view, showing the relative anatomical locations of the trabecular meshwork, the anterior chamber, and Schlemm's canal. Thick collagenous tissue known as sclera 11 covers the entire eye 10 except that portion covered by the cornea 12. The cornea 12 is a thin transparent tissue that focuses and transmits light into the eye and the pupil 14 which is the circular hole in the center of the iris 13 (colored portion of the eye). The cornea 12 merges into the sclera 11 at a juncture referred to as the limbus 15. The ciliary body 16 begins internally in the eye and extends along the interior of the sclera 11 and becomes the choroid 17. The choroid 17 is a vascular layer of the eye underlying retina 18. The optic nerve 19 transmits visual information to the brain and is sequentially destroyed by glaucoma.

[0048] The anterior chamber 20 of the eye 10, which is bound anteriorly by the cornea 12 and posteriorly by the iris 13 and lens 26, is filled with aqueous. Aqueous is produced primarily by the ciliary body 16 and reaches the anterior chamber angle 25 formed between the iris 13 and the cornea 12 through the pupil 14. In a normal eye, the aqueous is removed through the trabecular meshwork 21. Aqueous passes through trabecular meshwork 21 into Schlemm's canal 22 and through the aqueous veins 23 which merge with blood-carrying veins and into venous circulation. Intraocular pressure of the eye 10 is maintained by the intricate balance of secretion and outflow of the aqueous in the manner described above. Glaucoma is characterized by the excessive buildup of aqueous fluid in the anterior chamber 20 which produces an increase in intraocular pressure (fluids are relatively incompressible and pressure is directed equally to all areas of the eye).

[0049] As shown in FIG. 2, the trabecular meshwork 21 constitutes a small portion of the sclera 11. It is understandable that creating a hole or opening for implanting a device through the tissues of the conjunctiva 24 and sclera 11 is relatively a major surgery as compared to a surgery for implanting a device through the trabecular meshwork 21 only. A seton implant 31 of the present invention for either using or restoring existing outflow pathways positioned through the trabecular meshwork 21 is illustrated in FIG. 5.

[0050] In a first embodiment, a method for increasing aqueous humor outflow in an eye of a patient to reduce the intraocular pressure therein. The method comprises bypassing diseased trabecular meshwork at the level of the trabecular meshwork and thereby restoring existing outflow pathways. Alternately, a method for increasing aqueous humor outflow in an eye of a patient to reduce an intraocular pressure therein is disclosed. The method comprises bypassing diseased trabecular meshwork at a level of said trabecular meshwork with a seton implant and using existing outflow pathways. The seton implant 31 may be an elongated seton or other appropriate shape, size or configuration. In one embodiment of an elongated seton implant, the seton has an inlet end, an outlet end and a lumen therebetween, wherein the inlet end is positioned at an anterior chamber of the eye and the outlet end is positioned at about an exterior surface of said diseased trabecular meshwork. Furthermore, the outlet end may be positioned into fluid collection channels of the existing outflow pathways. Optionally, the existing outflow pathways may comprise Schlemm's canal 22. The outlet end may be further positioned into fluid collection channels up to the level of the aqueous veins with the seton inserted either in a retrograde or antegrade fashion with respect to the existing outflow pathways.

[0051] In a further alternate embodiment, a method is disclosed for increasing aqueous humor outflow in an eye of a patient to reduce an intraocular pressure therein. The method comprises (a) creating an opening in trabecular meshwork, wherein the trabecular meshwork comprises an interior side and exterior side; (b) inserting a seton implant into the opening; and (c) transporting the aqueous humor by said seton implant to bypass the trabecular meshwork at the level of said trabecular meshwork from the interior side to the exterior side of the trabecular meshwork.

[0052] FIG. 3 shows an embodiment of the seton implant 31 constructed according to the principles of the invention. The seton implant may comprise a biocompatible material, such as a medical grade silicone, for example, the material sold under the trademark Silastic, which is available from Dow Corning Corporation of Midland, Mich., or polyurethane, which is sold under the trademark Pellethane, which is also available from Dow Corning Corporation. In an alternate embodiment, other biocompatible materials (biomaterials) may be used, such as polyvinyl alcohol, polyvinyl pyrolidone, collagen, heparinized collagen, tetrafluoroethylene, fluorinated polymer, fluorinated elastomer, flexible fused silica, polyolefin, polyester, polysilison, mixture of biocompatible materials, and the like. In a further alternate embodiment, a composite biocompatible material by surface coating the above-mentioned biomaterial may be used, wherein the coating material may be selected from the group consisting of polytetrafluoroethlyene (PTFE), polyimide, hydrogel, heparin, therapeutic drugs, and the like.

[0053] The main purpose of the seton implant is to assist in facilitating the outflow of aqueous in an outward direction 40 into the Schlemm's canal and subsequently into the aqueous collectors and the aqueous veins so that the intraocular pressure is balanced. In one embodiment, the seton implant 31 comprises an elongated tubular element having a distal section 32 and an inlet section 44. A rigid or flexible distal section 32 is positioned inside one of the existing outflow pathways. The distal section may have either a tapered outlet end 33 or have at least one ridge 37 or other retention device protruding radially outwardly for stabilizing the seton implant inside said existing outflow pathways after implantation. For stabilization purposes, the outer surface of the distal section 32 may comprise a stubbed surface, a ribbed surface, a surface with pillars, a textured surface, or the like. The outer surface 36, including the outer region 35 and inner region 34 at the outlet end 33, of the seton implant is biocompatible and tissue compatible so that the interaction/irritation between the outer surface and the surrounding tissue is minimized. The seton implant may comprise at least one opening at a location proximal the distal section 32, away from the outlet end 33, to allow flow of aqueous in more than one direction. The at least one opening may be located on the distal section 32 at about opposite of the outlet end 33.

[0054] In another exemplary embodiment, the seton implant 31 may have a one-way flow controlling means 39 for allowing one-way aqueous flow 40. The one-way flow controlling means 39 may be selected from the group consisting of a check valve, a slit valve, a micropump, a semi-permeable membrane, or the like. To enhance the outflow efficiency, at least one optional opening 41 in the proximal portion of the distal section 32, at a location away from the outlet end 33, and in an exemplary embodiment at the opposite end of the outlet end 33, is provided.

[0055] FIG. 4 shows a top cross-sectional view of FIG. 3. The shape of the opening of the outlet end 33 and the remaining body of the distal section 32 may be oval, round or some other shape adapted to conform to the shape of the existing outflow pathways. This configuration will match the contour of Schlemm's canal to stabilize the inlet section with respect to the iris and cornea by preventing rotation.

[0056] As shown in FIG. 3, the seton implant of the present invention may have a length between about 0.5 mm to over a meter, depending on the body cavity the seton implant applies to. The outside diameter of the seton implant may range from about 30 m to about 500 m. The lumen diameter is preferably in the range between about 20 m to about 150 m. The seton implant may have a plurality of lumens to facilitate multiple flow transportation. The distal section may be curved at an angle between about 30 degrees to about 150 degrees, in an exemplary embodiment at around 70-110 degrees, with reference to the inlet section 44.

[0057] FIG. 5 shows another embodiment of the seton implant 45 constructed in accordance with the principles of the invention. In an exemplary embodiment, the seton implant 45 may comprise at least two sections: an inlet section 47 and an outlet section 46. The outlet section has an outlet opening 48 that is at the outlet end of the seton implant 45. The shape of the outlet opening 48 is preferably an oval shape to conform to the contour of the existing outflow pathways. A portion of the inlet section 47 adjacent the joint region to the outlet section 46 will be positioned essentially through the diseased trabecular meshwork while the remainder of the inlet section 47 and the outlet section 46 are outside the trabecular meshwork. As shown in FIG. 5, the long axis of the oval shape opening 48 lies in a first plane formed by an X-axis and a Y-axis. To better conform to the anatomical contour of the anterior chamber 20, the trabecular meshwork 21 and the existing outflow pathways, the inlet section 47 may preferably lie at an elevated second plane, at an angle , from the first plane formed by an imaginary inlet section 47A and the outlet section 46. The angle may be between about 30 degrees and about 150 degrees.

[0058] FIG. 6 shows a perspective view illustrating the seton implant 31, 45 of the present invention positioned within the tissue of an eye 10. A hole/opening is created through the diseased trabecular meshwork 21. The distal section 32 of the seton implant 31 is inserted into the hole, wherein the inlet end 38 is exposed to the anterior chamber 20 while the outlet end 33 is positioned at about an exterior surface 43 of said diseased trabecular meshwork 21. In a further embodiment, the outlet end 33 may further enter into fluid collection channels of the existing outflow pathways.

[0059] In one embodiment, the means for forming a hole/opening in the trabecular mesh 21 may comprise an incision with a microknife, an incision by a pointed guidewire, a sharpened applicator, a screw shaped applicator, an irrigating applicator, or a barbed applicator. Alternatively, the trabecular meshwork may be dissected off with an instrument similar to a retinal pick or microcurrette. The opening may alternately be created by retrograde fiberoptic laser ablation.

[0060] FIG. 7 shows an illustrative method for placing a seton implant at the implant site. An irrigating knife or applicator 51 comprises a syringe portion 54 and a cannula portion 55. The distal section of the cannula portion 55 has at least one irrigating hole 53 and a distal space 56 for holding a seton implant 31. The proximal end 57 of the lumen of the distal space 56 is sealed from the remaining lumen of the cannula portion 55.

[0061] For positioning the seton 31 in the hole or opening through the trabecular meshwork, the seton may be advanced over the guidewire or a fiberoptic (retrograde). In another embodiment, the seton is directly placed on the delivery applicator and advanced to the implant site, wherein the delivery applicator holds the seton securely during the delivery stage and releases it during the deployment stage.

[0062] In an exemplary embodiment of the trabecular meshwork surgery, the patient is placed in the supine position, prepped, draped and anesthesia obtained. In one embodiment, a small (less than 1 mm) self sealing incision is made. Through the cornea opposite the seton placement site, an incision is made in trabecular meshwork with an irrigating knife. The seton 31 is then advanced through the cornea incision 52 across the anterior chamber 20 held in an irrigating applicator 51 under gonioscopic (lens) or endoscopic guidance. The applicator is withdrawn and the surgery concluded. The irrigating knife may be within a size range of 20 to 40 gauges, preferably about 30 gauge.

[0063] From the foregoing description, it should now be appreciated that a novel approach for the surgical treatment of glaucoma has been disclosed for releasing excessive intraocular pressure. While the invention has been described with reference to a specific embodiment, the description is illustrative of the invention and is not to be construed as limiting the invention. Various modifications and applications may occur to those who are skilled in the art, without departing from the true spirit and scope of the invention, as described by the appended claims.