US-12622811-B2 - Insertion tool for an eye disease treatment device

US12622811B2US 12622811 B2US12622811 B2US 12622811B2US-12622811-B2

Abstract

Described herein are insertion tools for inserting a treatment device into a pocket formed between conjunctival tissue and scleral tissue for treating high intraocular pressure and glaucoma. An insertion tool ( 800 ) includes a scissoring mechanism or an expandable mechanism that is configured to expand a pocket formed between conjunctival tissue and scleral tissue. The scissoring mechanism or the expandable mechanism is also configured to unfurl a treatment device within the pocket.

Inventors

Rui Jing Jiang
Brandon Kao
Georgia Griggs
Michael Yates

Assignees

AVISI TECHNOLOGIES, INC.

Dates

Publication Date: 20260512
Application Date: 20220414

Claims (20)

1 . A system for lowing intraocular pressure, the system comprising: an insertion tool including: a first arm connected to a second arm at a pivot point forming a scissoring mechanism; a first prong connected to a first end of the first arm; and a second prong connected to a first end of the second arm, wherein the first and second prongs are configured to have a combined dimension that is less than a length of an incision of conjunctival tissue of a patient's eye when the first and second arms are in a closed position, and wherein the first and second arms are configured to be actuated to an open position after the first and second prongs are inserted into a pocket formed between the conjunctival tissue and scleral tissue of the patient's eye, wherein actuation to the open position causes the first and second prongs to separate and increase a width of the pocket; and a treatment device configured to furl or wrap around the first and second prongs when the first and second arms are in a closed position, wherein the first and second prongs are configured to cause the treatment device to unfurl or spread to a flat shape in the pocket when the first and second arms are actuated to the open position.
2 . The system of claim 1 , wherein the first and second prongs have at least a flat side to spread out the treatment device to the flat shape.
3 . The system of claim 1 , wherein the first and second prongs are configured to at least one of overlap or interlock when the first and second arms are in the closed position.
4 . The system of claim 1 , wherein the treatment device includes: a foldable plate comprising a first surface opposite a second surface, wherein the first surface includes a series of fluid channels; a first coating on the first surface; and a second coating on the second surface, wherein the fluid channels form a geometric pattern with each channel having a height and first width to produce a desired fluid flow rate.
5 . The system according to claim 4 , wherein the foldable plate includes an extension portion for placement within an anterior chamber of the patient's eye, and wherein the fluid channels include a plurality of open-ended channels interconnected to form an intersecting network of fluid pathways.
6 . The system of claim 1 , wherein the first and second prongs have at least one of a radiused edge or a blunted leading edge.
7 . The system of claim 1 , wherein the first and second prongs are shaped to match a shape of the unfurled treatment device.
8 . The system of claim 1 , wherein the first and second prongs are configured to expand to a predefined geometry that is greater than a surface of the unfurled treatment device.
9 . The system of claim 1 , wherein a cannula is provided over the first and second prongs to retain the furled treatment device during insertion into the pocket formed between the conjunctival tissue and scleral tissue of the patient's eye.
10 . The system of claim 1 , further comprising: a first handle connected to a second end of the first prong; and a second handle connected to a second end of the second prong.
11 . An insertion tool for a device that lowers intraocular pressure, the insertion tool comprising: a first arm having a first end and a second end; and a second arm having a first end and a second end, the second end of the second arm being connected to or integrally formed with the second end of the first arm, wherein the first arm and the second arm are bent or angled with respect to each other forming an expandable mechanism such that a first end of the first arm contacts the first end of the second arm when external force is absent, wherein the first ends of the first and second arms are configured to have a combined dimension that is less than a length of an incision of conjunctival tissue of a patient's eye when the first and second arms are in a closed position, and wherein the first and second arms are configured to be actuated to an open position after the first ends of the first and second arms are inserted into a pocket formed between the conjunctival tissue and scleral tissue of the patient's eye, wherein actuation to the open position causes the first ends to separate and increase a width of the pocket.
12 . The insertion tool of claim 11 , wherein the first end of the first arm and the first end of the second arm include flat surfaces.
13 . The insertion tool of claim 11 , wherein a treatment device is furled or wrapped around the first and second ends when the first and second arms are in a closed position, and wherein the first and second ends are configured to cause the treatment device to unfurl or spread to a flat shape in the pocket when the first and second arms are actuated to the open position.
14 . The insertion tool of claim 13 , wherein the treatment device includes: a foldable plate comprising a first surface opposite a second surface, wherein the first surface includes a series of fluid channels; a first coating on the first surface; and a second coating on the second surface, wherein the fluid channels form a geometric pattern with each channel having a height and first width to produce a desired fluid flow rate.
15 . The insertion tool of claim 11 , wherein the first and second arms include a hydrophobic coating.
16 . A method of inserting a treatment device to lower intraocular pressure, the method comprising: causing the treatment device to wrap around two prongs or ends of an expandable mechanism when the two prongs or ends are in a closed position; causing an incision to be made in conjunctival tissue of a patient's eye; causing the two prongs to go through the incision forming a pocket between the conjunctival tissue and scleral tissue of the patient's eye, an extension portion of the treatment device protruding from the incision; causing the two prongs to separate to an open position, thereby causing a width of the pocket to widen and causing the treatment device to unwrap to a flat sheet within the pocket; causing the two prongs to move to the closed position; and causing the two prongs of the expandable mechanism to be removed from the pocket through the incision, wherein a diameter of the two prongs and the wrapped treatment device is less than a diameter of the incision.
17 . The method of claim 16 , further comprising: causing a second incision to be made into the scleral tissue to provide access to an anterior chamber of the patient's eye; and causing the extension portion of the treatment device to be placed into at least a portion of the anterior chamber, thereby forming a fluid pathway between the anterior chamber and the pocket between the conjunctival tissue and scleral tissue of the patient's eye.
18 . The method of claim 16 , further comprising suturing the incision after removal of the two prongs.
19 . The method of claim 16 , further comprising: forming at least one suture hole on the treatment device using a laser; and reinforcing the at least one suture hole.
20 . The method of claim 19 , further comprising: causing tissue glue to be placed within the at least one suture hole; and after the treatment device unwraps, causing the tissue glue to anchor the treatment device to the scleral tissue.

Description

PRIORITY CLAIM This application is a national phase entry of PCT Application No. PCT/US2022/024789, filed on Apr. 14, 2022, which claims the benefit of U.S. Provisional Application No. 63/174,883, filed on Apr. 14, 2021, the entire disclosure of which are incorporated herein by reference. BACKGROUND Millions of individuals suffer from eye disease, specifically glaucoma. Most glaucoma patients have abnormally high intraocular pressure (IOP) due to the patient's inability to drain excessive aqueous humor from the anterior chamber of the eye through the trabecular meshwork. If not reduced with adequate treatment, high IOP will continuously damage the optic nerve as the disease progresses, leading to loss of vision or even total blindness. Current medications, surgeries, and implants have proven inadequate in lowering pressure within the eye or sustaining normal eye pressure over many years. Therefore, a need exists for new ways to alleviate IOP, thereby treating glaucoma. SUMMARY Described herein are treatment devices, or simply devices, configured for treating ocular and other conditions. In one embodiment, an ocular condition is elevated intraocular pressure, and the devices herein are configured to lower the intraocular pressure. In another embodiment, a condition is hydrocephalus, and the devices herein are configured to lower pressure. The devices generally include a plate structure or core component comprising a first major surface coated with a first material and a second major surface coated with a second material. The treatment device disclosed herein is configured for insertion into a subconjunctival pocket of a patient's eye. To reduce scaring and post-operative patient discomfort, it is desired to make as small as incision of the conjunctiva as possible, ideally less than 3 millimeters (“mm”). However, the treatment device, in many embodiments, has a width between 3 and 10 millimeters, preferably around 5 mm to provide to adequate drainage of aqueous humor from an anterior chamber of a patient's eye. This means that the treatment device is wider than a desired incision width. To enable insertion, the treatment device is folded or furled around an insertion device. After the insertion device passes through the conjunctiva incision, the insertion device is configured to unfold or unfurl the treatment device so that it rests flat or nearly flat within the subconjunctival pocket. In some embodiments, the example insertion device disclosed herein includes an expandable or scissoring mechanism with flat (overlapping) ends. After insertion, the expandable mechanism may be squeezed or the scissoring mechanism may be rotated, thereby causing the flat ends to separate and unfurl the treatment device within the subconjunctival pocket. In other embodiments, the insertion tool may include a forceps inserter that slides a furled treatment device in place, and then uses broad prongs to unfurl or flatten the treatment device. In yet other embodiments, a blunt tool having a width less than a width of the conjunctiva incision is used to unfurl the treatment device after insertion by another tool, such as tweezers or a needle/syringe (via an injection method). Other embodiments include methods of reducing intraocular pressure. In one embodiment, a method includes securing the treatment device as described herein to an eye thereby moving ocular fluids and reducing intraocular pressure. In some embodiments, the plate structure is formed of a ceramic material. The ceramic material can be selected from aluminum oxide (alumina), silicon nitride, silica, hafnium oxide, titanium nitride, titanium, or combinations thereof. In some embodiments, the first coating is a polymeric material. The polymeric material can be a parylene polymer. The parylene polymer can be parylene C, parylene D, parylene N, a derivative thereof or a combination thereof. In other embodiments, the polymeric material includes rubber, synthetic rubber, silicone polymers, parylene, thermoplastics, thermosets, polyolefins, polyisobutylene, acrylic polymers, ethylene-co-vinylacetate, polybutylmethacrylate, vinyl halide polymers, polyvinyl ethers, polyvinylidene halides, polyacrylonitrile, polyvinyl ketones, polyvinyl aromatics, polyvinyl esters, acrylonitrile-styrene copolymers, ABS resins, ethylene-vinyl acetate copolymers, polyamides, alkyd resins, polycarbonates, polyoxymethylenes, polyimides, polyethers, epoxy resins, polyurethanes, rayon, cellulose, cellulose acetate, cellulose butyrate, cellulose acetate butyrate, cellophane, cellulose nitrate, cellulose propionate, cellulose ethers, carboxymethyl cellulose, polytetrafluororethylene, poly(ether-ether-ketone), poly lactides such as PLA, PLGA, PLLA, derivatives thereof, or combinations thereof. In some embodiments, the second coating includes aluminum oxide and/or a parylene polymer. In some embodiments, the second coating includes aluminum oxide in combination with rubber, synthetic rubber, silicone pol