Patent Issued for Ocular device for treating glaucoma and related minimally invasive glaucoma surgery method (USPTO 11980574): University Hospitals Health System Inc.

2024 MAY 30 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- From Alexandria, Virginia, NewsRx journalists report that a patent by the inventors Orge, Faruk (Cleveland, OH, US), filed on August 19, 2019, was published online on May 14, 2024.

The patent’s assignee for patent number 11980574 is University Hospitals Health System Inc. (Cleveland, Ohio, United States).

News editors obtained the following quote from the background information supplied by the inventors: “It is estimated that approximately three million people in the United States have glaucoma, and more than one hundred thousand people are blind from glaucoma. Glaucoma is the second leading cause of blindness in adult Americans age eighteen to sixty-five and the leading cause of blindness in African Americans.

“Glaucoma is an optic neuropathy, or a disorder of the optic nerve, that is characterized by an elevated intraocular pressure. An increase in intraocular pressure may result in changes in the appearance (“cupping”) and function (“blind spots”) in the visual field of the optic nerve. If the pressure remains high enough for a long enough period of time, total vision loss may occur.

“The eye is a hollow structure that contains a clear fluid called aqueous humor. Aqueous humor is continuously produced in the posterior chamber of the eye by the ciliary body. The aqueous humor passes around the lens, through the pupillary opening in the iris and into the anterior chamber of the eye. Once in the anterior chamber, the aqueous humor drains out principally through a canalicular route that involves the trabecular meshwork and Schlemm’s canal. The trabecular meshwork and Schlemm’s canal are located at a junction between the iris and the cornea called the angle. The trabecular meshwork is composed of collagen beams arranged in a three-dimensional sieve-like structure and lined with a monolayer of trabecular cells. The outer wall of the trabecular meshwork coincides with the inner wall of Schlemm’s canal, which is a tube-like structure that runs around the circumference of the cornea.

“The aqueous humor, while being filtered, travels through the trabecular meshwork into the Schlemm’s canal, then from there through a series of collecting channels and reaches the episcleral venous system to be absorbed. In a healthy individual, aqueous humor production is approximately equal to aqueous humor outflow, and the intraocular pressure therefore remains fairly constant in the 10 to 21 mmHg range. High pressure develops in an eye because of an internal fluid imbalance. In glaucoma, the resistance through the canalicular outflow system is higher than normal causing reduced outflow, thereby causing an internal fluid imbalance and resulting in an increased pressure. In particular, the drainage angle formed by the cornea and the iris remains open, but the microscopic drainage channels in the trabecular meshwork are at least partially obstructed. Other forms of glaucoma may involve decreased outflow through the canalicular pathway due to mechanical blockage, inflammatory debris, cellular blockage and the like.

“When the drainage system does not function properly, the aqueous humor cannot filter out of the eye at its normal rate. As the fluid builds up, the intraocular pressure within the eye increases. The increased intraocular pressure compresses the axons of the optic nerve, which carries vision signals from the eye to the brain, and also may compromise the vascular supply to the optic nerve. Damage to the optic nerve is painless and slow, and a vision loss can occur before a person is even aware of a problem.

“There are various conventional ways of treating glaucoma. For example, eye and systemic medications are used to treat glaucoma by decreasing the production of aqueous humor or increasing its drainage from the eye.

“Surgical treatment may be performed when medications fail to lower the intraocular pressure. For example, surgical procedures may be used to open up the anatomically closed drainage pathways of the aqueous humor to outside the eye. A trabeculectomy is a surgical procedure that creates a pathway for aqueous humor to escape to the surface of the eye. The anterior chamber is entered beneath the scleral flap and a section of deep sclera and trabecular meshwork is excised. Post-operatively, the aqueous humor passes through the resulting hole and collects in an elevated space (subconjunctival reservoir) beneath the conjunctiva. The fluid then is either absorbed through blood vessels in the conjunctiva or traverses across the conjunctiva into the tear film. A deficiency of such procedure is that as the formed bleb is extremely thin, many times it can fail or erupt allowing a pathway for bacteria that normally live on the surface of the eye and eyelids to get into the eye.

“Another surgical procedure involves the use of an aqueous shunt. A full thickness hole is made into the eye at the limbus, usually with a needle. The shunt is inserted into the eye through this hole and aqueous humor drains out to the surface of the eye. The tube is attached to a plate and this pate is placed underneath the extraocular muscles. The plate helps to create a reservoir again underneath the conjunctiva to where the aqueous humor drains. Many complications are associated with aqueous shunts. A thickened wall of scar tissue may resist outflow and limit the reduction in eye pressure. The bleb may not form quickly or not at all, resulting in an unrestricted flow through the shunt to the outer surface causing too low of an intraocular pressure that can damage the eye in different ways that could lead to loss of function and sight. As such shunts may erode through the overlying tissues creating an opening to the surface of the eye, a pathway is created for bacteria to get into the eye and endophthalmitis can occur.

“Laser surgery is a surgical procedure to reduce the intraocular pressure and includes cyclophotocoagulation (reducing the production of aqueous humor by using a laser to burn the part of the eye that produces aqueous humor), iridotomy (use of a laser to make a hole in the iris to allow fluid to flow more freely in the eye), and trabeculoplasty (use of a laser to create holes in the drainage area of the eye to allow fluid to drain more freely). However, laser surgery is complex and suffers from a variety of deficiencies, including reduced effectiveness, inflammation and related complications.

“Accordingly, standard glaucoma surgeries are major surgeries that have significant deficiencies. While such surgeries are very often effective at lowering eye pressure and preventing progression of glaucoma, they have a long list of potential complications. To overcome such deficiencies, more advanced techniques have been developed which are commonly referred to as “minimally invasive glaucoma surgery” or MIGS. MIGS procedures work by using microscopic-sized equipment and tiny incisions. While they reduce the incidence of complications, some degree of effectiveness is also traded for the increased safety.

“The MIGS group of operations generally are divided into several categories: miniaturized versions of trabeculectomy; trabecular bypass operations; totally internal or supra-choroidal shunts; milder or gentler versions of laser photocoagulation; and ab-interno canaloplasty (ABiC). Generally, the MIGS procedures work by either bypassing the blocked trabecular meshwork (e.g., trabecular bypass operations and using supra-choroidal shunts), allowing the aqueous humor to drain to another potential space or by opening the Schlemm’s canal and the collector channels (ABiC), or by decreasing the production of the aqueous humor (laser photocoagulation). Because of the advantage of MIGS procedures over more conventional treatments, efforts to improve such procedures are on-going.”

As a supplement to the background information on this patent, NewsRx correspondents also obtained the inventors’ summary information for this patent: “The present invention relates to an ocular device and related minimally invasive glaucoma surgery (MIGS) for treating glaucoma with the ocular device. The described technique includes accessing the Schlemm’s canal through a very small guide hole made at the trabecular meshwork. A guide wire, such as for example a suture, probe wire, I-track system or the like, is threaded through the guide hole. A trabecular meshwork bypass device is guided along the guide wire for proper placement for bypassing a blocked portion or portions of the trabecular meshwork. A canaloplasty probing device having a lumen further may be employed to aid insertion of the guide wire and bypass device, and to introduce substances into the trabecular meshwork and/or Schlemm’s canal such as glaucoma medications, anti-inflammatory agents, antibiotic releasing pellets, viscoelastic materials and the like.

“As the system including the guide wire and bypass device is threaded through the lumen of the probing device (if applicable) or otherwise threaded into the eye through the guide hole, a visualization agent, with or without a viscoelastic substance, is injected into the area in which the bypass device is to be implanted. This allows the Schlemm’s canal and the collector channels to be reopened, and also lubricates and expands the Schlemm’s canal. The visualization agent may be a dye, such as for example fluoresceine, tripan blue, or other suitable dye, or a physical visible agent such as micro-bubbles. The visualization agent may be visualized using any suitable imaging technique, such as for example optical coherence tomography or ultrasound bio-microscopy. Imaging of the visualization agent flowing through the drainage system allows the Schlemm’s canal, trabecular meshwork and the collector channels to be viewed in great detail, which allows the surgeon to further identify the clogged areas of the trabecular meshwork/Schlemm’s canal/collector channels versus open channels to ascertain an optimal location for insertion of the bypass device to either bypass the problem or to open the blocked area.

“The bypass device includes tips that penetrate through the trabecular meshwork to provide open channels through the trabecular meshwork for draining the aqueous humor. As the Schlemm’s canal walls are opened by the viscoelastic and/or the guide wire, this allows easier penetration of the tips of the bypass device through the trabecular meshwork into the Schlemm’s canal. Once the bypass device is properly placed, then the guide wire and any canaloplasty probing device are retrieved while leaving the bypass device in place.

“In exemplary embodiments, the bypass device has an open tubular structure that is laser cut with pronged features to create open tented holes through the trabecular meshwork. The tubular structure may include multiple arrow-shaped tangs that are formed within a tubular base, with the tubular base having a curvature that approximates a curvature of the iridocorneal angle structures. One or more pairs of adjacent tangs may be flexed at the desired locations to form the tents that are inserted through the trabecular meshwork. In particular, the tents may be formed at clogged locations of the trabecular meshwork as determined by the visualization techniques described above. A heat setting process may be employed to securely implant the tents of the bypass device through the trabecular meshwork. The heat setting process may constitute a lateral angle heat set to impart side-to-side forces during release of the guide wire to create tissue engagement with the trabecular meshwork. In an exemplary embodiment, the arrow-shaped tangs that are used to form the tents may be offset arrows, which may improve holding of the bypass device to the trabecular meshwork.

“As an alternative or addition to implantation of a bypass device, the guide wire and canaloplasty probing device may be used to insert glaucoma medication, anti-inflammatory agents, antibiotic releasing pellets, and the like into the trabecular meshwork and/or Schlemm’s canal for further success in intra-ocular pressure reduction, and for prevention of inflammation and related complications and infections. In addition, a second guide wire can be threaded through the lumen of the canaloplasty probing device and/or around the canaloplasty probing device to help maintain the efficacy of the Schlemm’s canal opening. Studies of prior techniques have demonstrated that de-clogging and maintaining the efficacy of the Schlemm’s canal opening aids with long term reduction of intra-ocular pressure.”

The claims supplied by the inventors are:

“1. A bypass device for providing fluid channels through a body tissue, the bypass device comprising: an open tubular base; and a plurality of pronged features attached to the open tubular base, the pronged features being reconfigurable from a first position to a second position; wherein in the first position the pronged features extend longitudinally along a plane of the open tubular base, and the pronged features are reconfigurable to the second position by flexing the pronged features relative to the tubular base, such that in the second position the pronged features are configured for insertion through the body tissue, wherein the pronged features are associated in pairs, with individual pronged features of a pair of pronged features being attached to each other via a web, and the pronged features are reconfigurable from the first position to the second position by flexing opposing pronged features of the pair about the web, and wherein individual tangs within a pair of opposing pronged features are offset relative to each other along the longitudinal axis of the open tubular base.

“2. The bypass device of claim 1, wherein the pronged features are configured as multiple arrow-shape tangs that are formed within the tubular base.

“3. The bypass device of claim 2, wherein each arrow-shaped tang includes a neck that is flexible relative to the tubular base, and an arrow-shape head that is flexible relative to the neck.

“4. The bypass device of claim 2, wherein each individual tang includes a tapered edge that runs from the tubular base to an arrow-shaped head of the tang.

“5. The bypass device of claim 1, wherein in the second position the pronged features are configured as tent structures.

“6. The bypass device of claim 5, wherein opposing ends of the pronged features are oriented at an angle relative to each other upon formation of the tent structures.

“7. A method of performing a minimally invasive glaucoma surgery (MIGS) for treating glaucoma comprising the steps of: providing a bypass device for bypassing a drainage system of an eye including Schlemm’s canal, trabecular meshwork, and collector channels, the bypass device comprising: an open tubular base; and a plurality of pronged features attached to the open tubular base, the pronged features being reconfigurable from a first position to a second position; wherein in the first position the pronged features extend longitudinally along a plane of the open tubular base, and the pronged features are reconfigurable to the second position by flexing the pronged features relative to the tubular base, such that in the second position the pronged features are configured for insertion through a body tissue; forming a guide hole to access a Schlemm’s canal at a trabecular meshwork of an eye; inserting the bypass device through the guide hole and positioning the bypass device within the Schlemm’s canal adjacent to the trabecular meshwork; reconfiguring a portion of the pronged features from the first position to the second position to form one or more tent structures; and inserting the one or more tent structures of the bypass device into the trabecular meshwork, wherein the one or more tent structures form tent holes through the trabecular meshwork to define fluid flow channels through the trabecular meshwork.

“8. The MIGS method of claim 7, further comprising performing a visualization technique to locate clogged portions of the drainage system, wherein the bypass device is aligned relative to the trabecular meshwork such that the one or more tent structures are positioned at or adjacent to respective clogged portions of the trabecular meshwork as determined by the visualization technique.

“9. The MIGS method of claim 7, further comprising performing a heat setting process to securely implant the tent structures in the trabecular meshwork.

“10. The MIGS method of claim 9, further comprising performing a heat setting process to securely implant the tent structures in the trabecular meshwork, wherein the heat setting process includes a lateral angle heat set to impart side-to-side forces during release of the guide wire to create tissue engagement of the bypass device with the trabecular meshwork.

“11. The MIGS method of claim 7, further comprising injecting a viscoelastic substance into the Schlemm’s canal to expand the Schlemm’s canal to aid inserting the bypass device.

“12. The MIGS method of claim 7, further comprising inserting a canaloplasty device having a lumen through the guide hole, introducing one or more substances into the Schlemm’s canal through the lumen, and removing the canaloplasty device after inserting the bypass device into the trabecular meshwork.

“13. The MIGS method of claim 12, wherein the one or more substances include a guide wire to aid in positioning the bypass device, glaucoma medication, anti-inflammatory agents, and/or antibiotic releasing pellets.”

For additional information on this patent, see: Orge, Faruk. Ocular device for treating glaucoma and related minimally invasive glaucoma surgery method. U.S. Patent Number 11980574, filed August 19, 2019, and published online on May 14, 2024. Patent URL (for desktop use only): https://ppubs.uspto.gov/pubwebapp/external.html?q=(11980574)&db=USPAT&type=ids

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