Glaucoma implant with multiple openings

Abstract

Surgical methods and related medical devices for treating glaucoma are disclosed. The method comprises trabecular bypass surgery, which involve bypassing diseased trabecular meshwork with the use of a seton implant. The seton implant is used to prevent a healing process known as filling in, which has a tendency to close surgically created openings in the trabecular meshwork. The surgical method and novel implant are addressed to the trabecular meshwork, which is a major site of resistance to outflow in glaucoma. In addition to bypassing the diseased trabecular meshwork at the level of the trabecular meshwork, existing outflow pathways are also used or restored. The seton implant is positioned through the trabecular meshwork so that an inlet end of the seton implant is exposed to the anterior chamber of the eye and an outlet end is positioned into fluid collection channels at about an exterior surface of the trabecular meshwork or up to the level of aqueous veins.

Description

CLAIM OF PRIORITY AND RELATED APPLICATIONS [0001] This patent application is a continuation application of U.S. patent application Ser. No. 10 / 395,631, filed Mar. 21, 2003, which is a continuation application of U.S. patent application Ser. No. 09 / 549,350, filed Apr. 14, 2000, both of which are incorporated in their entirety by reference herein.FIELD OF THE INVENTION [0002] The present invention generally relates to improved medical devices and methods for the reduction of elevated pressure in organs of the human body. More particularly, the present invention relates to the treatment of glaucoma by trabecular bypass surgery, which is a means for using an implant or seton, such as a micro stent, shunt or the like, to bypass diseased trabecular meshwork at the level of trabecular meshwork and use / restore existing outflow pathways. BACKGROUND OF THE INVENTION [0003] About two percent of people in the United States have glaucoma. Glaucoma is a group of eye diseases that causes pathologi...

AI Technical Summary

Benefits of technology

[0033] One of the advantages of trabecular bypass surgery, as disclosed herein, and the use of a seton implant to bypass diseased trabecular meshwork at the level of trabecular meshwork and thereby use existing outflow pathways is that the treatment of glaucoma is substantially simpler than in existing therapies. A further advantage of the invention is the utilization of simple microsurgery that may be performed on an outpatient basis with rapid visual recovery and greatly decreased morbidity. Finally, a distinctly different approach is used than is found in existing implants. Physiological outflow mechanisms are used or re-established by the implant of the present invention, in contradistinction with previously disclosed methodologies.

is the utilization of simple microsurgery that may be performed on an outpatient basis with rapid visual recovery and greatly decreased morbidity. Finally, a distinctly different approach is used than is found in existing implants. Physiological outflow mechanisms are used or re-established by the implant of the present invention, in contradistinction with previously disclosed methodologies.

Problems solved by technology

Glaucoma is a group of eye diseases that causes pathological changes in the optic disk and corresponding visual field loss resulting in blindness if untreated.

However, there are secondary open-angle glaucomas which may include edema or swelling of the trabecular spaces (from steroid use), abnormal pigment dispersion, or diseases such as hyperthyroidism that produce vascular congestion.

However, these various drug therapies for glaucoma are sometimes associated with significant side effects, such as headache, blurred vision, allergic reactions, death from cardiopulmonary complications and potential interactions with other drugs.

However, long-term review of surgical results showed only limited success in adults.

In retrospect, these procedures probably failed secondary to repair mechanisms and a process of “filling in”.

The filling in is the result of a healing process which has the detrimental effect of collapsing and closing in of the created opening throughout the trabecular meshwork.

Once the created openings close, the pressure builds back up and the surgery fails.

However, the relatively small hole created by this trabeculopuncture technique exhibits a filling in effect and fails.

Although morbidity was zero in both trials, success rates did not warrant further human trials.

Failure again was from filling in of created defects in trabecular meshwork by repair mechanisms.

The risk of placing a glaucoma drainage implant also includes hemorrhage, infection and postoperative double vision that is a complication unique to drainage implants.

All of the above embodiments and variations thereof have numerous disadvantages and moderate success rates.

They involve substantial trauma to the eye and require great surgical skill by creating a hole over the full thickness of the sclera / cornea into the subconjunctival space.

Furthermore, normal physiological outflow pathways are not used.

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