INSERTION TOOL FOR AN EYE DISEASE TREATMENT DEVICE

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.

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 some embodiments, the second coating includes aluminum oxide and/or a parylene polymer.

The series of fluid channels can include a plurality of open-ended channels interconnected to form an intersecting network (or grid pattern) of fluid pathways. In some embodiments, the channels are microchannels.

In some embodiments, treating the high intraocular pressure is a treatment for glaucoma.

In some embodiments, treating the high intraocular pressure is a treatment for glaucoma.

In light of the disclosure set forth herein, and without limiting the disclosure in any way, in a first aspect of the present disclosure, which may be combined with any other aspect, or portion thereof, described herein a system for lowing intraocular pressure includes an insertion tool comprising 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. 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. 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. Actuation to the open position causes the first and second prongs to separate and increase a width of the pocket. The system additionally includes 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. 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.

In a second aspect of the present disclosure, which may be combined with any other aspect, or portion thereof, described herein, the first and second prongs have at least a flat side to spread out the treatment device to the flat shape.

In a third aspect of the present disclosure, which may be combined with any other aspect, or portion thereof, described herein, the first and second prongs are configured to at least one of overlap or interlock when the when the first and second arms are in the closed position.

In a fourth aspect of the present disclosure, which may be combined with any other aspect, or portion thereof, described herein, 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. The fluid channels form a geometric pattern with each channel having a height and first width to produce a desired fluid flow rate.

In a fifth aspect of the present disclosure, which may be combined with any other aspect, or portion thereof, described herein, the foldable plate includes an extension portion for placement within an anterior chamber of the patient's eye, and the fluid channels include a plurality of open-ended channels interconnected to form an intersecting network of fluid pathways.

In a sixth aspect of the present disclosure, which may be combined with any other aspect, or portion thereof, described herein, the first and second prongs have at least one of a radiused edge or a blunted leading edge.

In a seventh aspect of the present disclosure, which may be combined with any other aspect, or portion thereof, described herein, the first and second prongs are shaped to match a shape of the unfurled foldable plate.

In an eighth aspect of the present disclosure, which may be combined with any other aspect, or portion thereof, described herein, the first and second prongs are configured to expand to a predefined geometry that is greater than a surface of the unfurled foldable plate.

In a ninth aspect of the present disclosure, which may be combined with any other aspect, or portion thereof, described herein, 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.

In a tenth aspect of the present disclosure, which may be combined with any other aspect, or portion thereof, described herein, the system further includes 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.

In an eleventh aspect of the present disclosure, which may be combined with any other aspect, or portion thereof, described herein, an insertion tool for a device that lowers intraocular pressure comprises 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 is connected to or integrally formed with the second end of the first arm. 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. 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. Additionally, 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.

In a twelfth aspect of the present disclosure, which may be combined with any other aspect, or portion thereof, described herein, the first end of the first arm and the first end of the second arm include flat surfaces.

In a thirteenth aspect of the present disclosure, which may be combined with any other aspect, or portion thereof, described herein, 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 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.

In a fourteenth aspect of the present disclosure, which may be combined with any other aspect, or portion thereof, described herein, 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. The fluid channels form a geometric pattern with each channel having a height and first width to produce a desired fluid flow rate.

In a fifteenth aspect of the present disclosure, which may be combined with any other aspect, or portion thereof, described herein, the first and second arms include a hydrophobic coating.

In a sixteenth aspect of the present disclosure, which may be combined with any other aspect, or portion thereof, described herein, a method of inserting a treatment device to lower intraocular pressure comprises 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 to conjunctival tissue of a patient's eye, and 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. The method also includes causing the two prongs to separate to an open position and causing a width of the pocket to widen. The method further includes 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. A diameter of the two prongs and the wrapped treatment device is less than a diameter of the incision.

In a seventeenth aspect of the present disclosure, which may be combined with any other aspect, or portion thereof, described herein, the method further comprises 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.

In an eighteenth aspect of the present disclosure, which may be combined with any other aspect, or portion thereof, described herein, the method further includes suturing the incision after removal of the two prongs.

In a nineteenth aspect of the present disclosure, which may be combined with any other aspect, or portion thereof, described herein, the method further includes forming at least one suture hole on the treatment device using a laser, and reinforcing the at least one suture hole.

In a twentieth aspect of the present disclosure, which may be combined with any other aspect, or portion thereof, described herein, the method further includes 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.

In a twenty-first aspect any of the features, functionality and alternatives described in connection with any one or more ofFIGS.1to13may be combined with any of the features, functionality and alternatives described in connection with any other ofFIGS.1to13.

Additional features and advantages are described in, and will be apparent from, the following Detailed Description and the Figures. The features and advantages described herein are not all-inclusive and, in particular, many additional features and advantages will be apparent to one of ordinary skill in the art in view of the figures and description. Also, any particular embodiment does not have to have all of the advantages listed herein and it is expressly contemplated to claim individual advantageous embodiments separately. Moreover, it should be noted that the language used in the specification has been selected principally for readability and instructional purposes, and not to limit the scope of the inventive subject matter.

DETAILED DESCRIPTION

The following description of the embodiment(s) is merely exemplary in nature and is in no way intended to limit the invention, its application, or uses.

Reference is made herein to lowering intraocular pressure. However, it should be appreciated that the disclosed devices and methods may low fluid pressure of other organs or tissue. For example, the disclosed devices and methods may be used to lower an accumulation of fluid in the brain.

Terms such as “attached,” “affixed,” “connected,” “coupled,” “interconnected,” and similar refer to a relationship wherein structures are secured or attached to one another either directly or indirectly through intervening structures, as well as both movable or rigid attachments or relationships, unless expressly described otherwise. Moreover, the features and benefits of the invention are illustrated by reference to the exemplified embodiments. Accordingly, the invention expressly should not be limited to such exemplary embodiments illustrating some possible non-limiting combination of features that may exist alone or in other combinations of features; the scope of the invention being defined by the claims appended hereto.

Unless otherwise specified, all percentages and amounts expressed herein and elsewhere in the specification should be understood to refer to percentages by weight. The amounts given are based on the weight of the material. According to the present application, the term “about” means +/−5% of the reference value. According to the present application, the term “substantially free” means less than about 0.1 wt. % based on the total of the referenced value.

A “subject” herein may be a human or a non-human animal, for example, but not by limitation, rodents such as mice, rats, hamsters, and guinea pigs; rabbits; dogs; cats; sheep; pigs; goats; cattle; horses; and non-human primates such as apes and monkeys, etc.

Treatment Device Embodiment

Referring toFIGS.1-3, a treatment device1includes a plate structure200, or simply plate, having a first major exposed surface201opposite a second major exposed surface202as well as side surface203extending there-between. The plate structure200can comprise an extension portion250and a main body portion240.

The plate structure200can be formed of any material with appropriate characteristics for implantation and treatment. In some embodiments, the plate structure200can be formed of a metal, polymer, ceramic (e.g., aluminum oxide), other composite material, or a combination thereof. Metals can include, but are not limited to aluminum, titanium, zinc, platinum, tantalum, copper, nickel, rhodium, gold, silver, palladium, chromium, iron, indium, ruthenium, osmium, tin, iridium, or combinations, and alloys thereof. In some embodiments, alloys can include steel and nickel titanium such as Nitinol.

Polymers or polymer materials used to form plate structure200can include any of the polymers described herein.

Composites such as silicon composites can also be used. In one embodiment, a composite can include silicon nitride (Si3N4). The silicon nitride can have any known crystalline structure such as, but not limited to, trigonal α-Si3N4, hexagonal β-Si3N4, or cubic γ-Si3N4.

The plate structure200, or plate, can have a thickness ranging from about 1 nm to about 1,000 nm, from about 1 nm to about 500 nm, from about 1 nm to about 400 nm, from about 100 nm to about 1,000 nm, from about 200 nm to about 1,000 nm, from about 300 nm to about 1,000 nm, from about 400 nm to about 1,000 nm, from about 1 nm to about 900 nm, from about 1 nm to about 800 nm, from about 1 nm to about 700 nm, from about 1 nm to about 600 nm, from about 300 nm to about 500 nm, from about 300 nm to about 600 nm, from about 400 nm to about 600 nm, from about 200 nm to about 600 nm, from about 200 nm to about 500 nm, or from about 50 nm to about 800 nm.

The plate structure200may comprise a multi-directional plate210comprising a first major surface211opposite a second major surface212. The multi-directional plate210may form a plurality of topographical features (for example, a repeating honeycomb pattern) on each of the first major surface211and the second major surface212. Each of the first and second topographies may independently comprise a plurality of channels232and/or a plurality of open-cells222.

The plurality of channels232may be interconnected and can form a network of channels. The channels may be open or closed, allowing fluid to readily enter each channel of plurality of channels232and flow through it. The network may comprise intersecting channels in any suitable configuration to best help promote the flow of fluid across the plate structure200via the plurality of channels232. In one embodiment, the channels232may be configured to form hexagonal patterns. Once treatment device1, illustrated inFIG.1, is implanted, fluid (e.g., aqueous humor) may be driven by a pressure gradient to flow through the channels and across the surface of plate structure200.

In some embodiments, the channels232can include a ribbing pattern. The ribbing pattern and/or the geometry of the channels in the plate can be varied based on different severities of disease (e.g., mild, moderate, or severe glaucoma). In one embodiment, larger or smaller channels can be used to decrease intraocular pressure by different amounts. Changing intraocular pressure by a lower amount can decrease risk of hypotony (a condition that can exist if intraocular pressure is reduced too much) and increase efficacy at lowering pressure to a target level. In some embodiments, a device as described herein with smaller channels can decrease flow and decrease risk of hypotony. Likewise, larger channels can increase flow and allow the device to reduce intraocular pressure to a lower level.

The plate structure200may further comprise a first coating280applied to the first major surface211of the multi-directional plate210. The first coating280may conform to the first topography of the first major surface211of the multi-directional plate210. In other embodiments, the first coating280may form a topography that does not conform to the first topography of the first major surface211of the multi-directional plate210.

The first coating280may have a thickness ranging from about 0.1 μm to about 10 μm or about 0.1 μm to about 2 μm—including all thickness and sub-ranges there-between. In one embodiment, the thickness is between about 0.4 μm (400 nm) and 0.6 μm (600 nm). In one embodiment, the thickness is about 0.4 μm (400 nm). In other embodiments, the thickness is between about 1 μm and about 5 μm, between about 1 μm and about 3 μm, between about 2 μm and about 5 μm, or between about 2 μm and about 4 μm. In one embodiment, the thickness is about 2 μm.

The plate structure200may further comprise a second coating290applied to the second major surface212of the multi-directional plate210. The second coating290may conform to the plurality of surface features on the second major surface212of the multi-directional plate210. In other embodiments, the second coating290may form a topography that does not conform to the second topography of the second major surface212of the multi-directional plate210.

The second coating290may have a thickness ranging from about 0.1 μm to about 10 μm or about 0.1 μm to about 1 μm—including all thickness and sub-ranges there-between. In one embodiment, the thickness is between about 0.4 μm (400 nm) and 0.6 μm (600 nm). In one embodiment, the thickness is about 0.4 μm (400 nm). In other embodiments, the thickness is between about 1 μm and about 5 μm, between about 1 μm and about 3 μm, between about 2 μm and about 5 μm, or between about 2 μm and about 4 μm. In one embodiment, the thickness is about 2 μm.

In some embodiments, the plate structure200may comprise only the first coating280—i.e., no second coating. In other embodiments, the plate structure200may comprise only the second coating290—i.e., no first coating. In other embodiments, the plate structure200may comprise the first coating280and the second coating290, whereby the first and second coatings overlap to fully encapsulate the multi-directional plate210. In such embodiments, the side surface203of the plate structure200may comprise at least one of the first coating280and the second coating290.

In some embodiments, the first and second coating, and any edge coating, can be thicker than the plate itself. In some embodiments, the coating thickness can be one, two or three orders of magnitude thicker than the plate structure. However, in other embodiments, the plate can be thicker than each coating or the additive thickness of the two coatings.

Coatings described herein can be applied by any suitable deposition method, such as but not limited to, physical vapor deposition, chemical vapor deposition, atomic layer deposition, spray coating, spin coating, self-assembly, dip coating, or brushing.

The first coating280may be applied to the first major surface211by any suitable deposition method. In a non-limiting example, the first coating280may be applied to the first major surface211by chemical vapor deposition, physical vapor deposition, or plasma-enhanced chemical vapor deposition. In another non-limiting example, the first coating280may be applied to the first major surface211by atomic layer deposition. In another non-limiting example, the first coating280may be applied to the first major surface211by spray coating. In another non-limiting example, the first coating280may be applied to the first major surface211by dip coating. In another non-limiting example, the first coating280may be applied to the first major surface211by brushing.

The second coating290may be applied to the second major surface212by any suitable deposition method. In a non-limiting example, the second coating290may be applied to the second major surface212by chemical vapor deposition, physical vapor deposition, or plasma-enhanced chemical vapor deposition. In another non-limiting example, the second coating290may be applied to the second major surface212by atomic layer deposition. In another non-limiting example, the second coating290may be applied to the second major surface212by spray coating. In another non-limiting example, the second coating290may be applied to the second major surface212by dip coating. In another non-limiting example, the second coating290may be applied to the second major surface212by brushing.

The first coating280may be the same as the second coating290. The first coating280and the second coating290may be different. The first coating280may be hydrophilic. The first coating280may be hydrophobic. The first coating280may be lipophilic. The first coating280may be lipophobic. The second coating290may be hydrophilic. The second coating290may be hydrophobic. The second coating290may be lipophilic. The second coating290may be lipophobic. Each of the first and second coatings280,290may independently be continuous. Each of the first and second coatings280,290may independently be discontinuous. In some embodiments, the first and second coatings280,290may both be hydrophobic. In some embodiments, the first and second coatings280,290may both be hydrophilic. In some embodiments, the first and second coatings280,290may both be lipophilic or lipophobic.

The first coating280may be organic. The first coating280may be inorganic. The second coating290may be organic. The second coating290may be inorganic.

In some embodiments, the first coating280is hydrophilic and the second coating290is hydrophobic. In some embodiments, the first coating280is hydrophilic and the second coating290is hydrophilic. Having at least one of the first and/or second coating280,290be hydrophobic may help prevent the treatment device1from inadvertently sticking to tissue during implantation.

In some embodiments, a purpose of a first and/or second coating is to increase the toughness of the device. Also, a first and/or second coating can increase biocompatibility of the device and/or decrease scarring by decreasing tissue and/or fibroblast adhesion. In some embodiments, the coatings described herein are hydrophobic and decrease tissue adhesion. In some embodiments, tissue adhesion can be reduced by greater than about 10%, greater than about 60%, greater than about 70%, greater than about 80%, greater than about 90%, greater than about 95%, greater than about 96%, greater than about 97%, greater than about 98%, or greater than about 99% when compared to an uncoated plate.

In a non-limiting embodiment, the first and/or second coating may comprise a polymer, such as a parylene polymer (poly(para-xylylene)) or a derivative thereof. In other embodiments, the first and/or second coating can include aluminum oxide, a biocompatible film, a porous coating, or a lubricious coating. In one embodiment, the parylene polymer is a chlorine modified poly(para-xylylene), or a fluorine modified poly(para-xylylene). In one embodiment, the parylene polymer can be parylene C, parylene D, parylene N, a derivative thereof or a combination thereof. In other embodiments, the first and/or second coating can include aluminum oxide.

The resulting the treatment device1may comprise the first plurality of channels222present on the first exposed major surface201of the plate structure200, wherein the first plurality of channels222are hydrophilic due to the presence of the first coating280. The resulting treatment device1may comprise the second plurality of channels232present on the second exposed major surface202of the plate structure200, wherein the second plurality of channels232are hydrophilic due to the presence of the second coating290. As discussed, the hydrophilic channels may promote fluid flow through the channels after the treatment device1has been implanted into a subject's eye.

Referring toFIGS.4,5A,5B, and5C, generally, a treatment device1001is illustrated in accordance with another embodiment. The treatment device1001is similar to the treatment device1except as described herein below. The description of the treatment device1above generally applies to the treatment device1001described below except with regard to the differences specifically noted below. A similar numbering scheme will be used for the treatment device1001as with the treatment device1except that a “1000” series of numbering will be used.

The treatment device1001comprises a plate structure1200having a first exposed major surface1201that is opposite a second exposed major surface1202. The plate structure1200may comprise a multi-directional plate1210comprising a first major surface1211opposite a second major surface1212. The multi-directional plate1210may form a plurality of topographical features (for example, a repeating honeycomb pattern) on each of the first major surface1211and the second major surface1212. Each of the first and second topographies may independently comprise a plurality of channels1232and/or a plurality of open-cells1222.

Referring now toFIG.5B, the plate structure1200may comprise a first delivery component1070present in the open voids created by the first topography formed by the first exposed surface1211of the multi-directional plate1210. Specifically, the first delivery component1070may be present in the open voids created by the open-cells1222of first topography formed by the first major surface1211of the multi-directional plate1210.

The first delivery component1070may comprise one or more active agents such as, but not limited to therapeutic and/or pharmacological components. The first delivery component1070may occupy some, all, or substantially all of the free volume present in the open-cells1222formed by the first topography.

The treatment device1001may further comprise a first coating1050applied to a first major surface1211of the multi-directional plate1210. The first coating1050may cover both a first major surface1211of the multi-directional plate1210as well as a first delivery component1070that is present in the open-cells1222formed into the first major surface1211of the multi-directional plate1210. The first coating1050may be in the form of a continuous film. The first coating1050may be flat. In other embodiments, the first coating1050may be conformal to the underlying pattern formed by the multi-directional plate1210and the first delivery component1070.

Referring now toFIG.5A, the plate structure1200may comprise a second delivery component1080present in the open voids created by the second topography formed by the second exposed surface1212of the multi-directional plate1210. Specifically, the second delivery component1080may be present in the open voids created by the open-channels1232of the second topography formed by the second major surface1212of the multi-directional plate1210. The second delivery component1080may be the same or different from the first delivery component1070.

The second delivery component1080may comprise one or more therapeutic and/or pharmacological components—including but not limited to anti-inflammatory agents, steroids, antibiotics, analgesics. The second delivery component1080may occupy some, all, or substantially all of the free volume present in the channels1232formed by the first topography.

The treatment device1001may further comprise a second coating1060applied to a second major surface1212of the multi-directional plate1210. The second coating1060may cover both the second major surface1212of the multi-directional plate1210as well as the second delivery component1080that is present in the open-channels1232formed into the second major surface1212of the multi-directional plate1210. The second coating1060may be in the form of a continuous film. The second coating1060may be flat. In other embodiments, the second coating1060may be conformal to the underlying pattern formed by the multi-directional plate1210and the second delivery component1080.

The second coating1060may be the same or different than the first coating1050. For each of the first and the second coatings1050,1060, the resulting film may be formed from a slow-release material that dissolves slowly after exposure to aqueous humor or other biological fluids, thereby releasing the first delivery component1070from the channels1232of the treatment device1001after it has been implanted into a subject.

Referring now toFIG.5C, in other embodiments, the treatment device1001may comprise both the first and the second delivery components1070,1080, as well as the first and the second coatings1050,1060to encapsulate the first and second delivery components1070,1080.

In other embodiments, the plate structure1200may comprise at least one of the first coating1050and/or the second coating1060without the presence of the first and/or second delivery components1070,1080. In such embodiments, the first coating1050and/or the second coating1060may form a film that covers the open cells1222and/or the open channels1232created by the multi-directional plate.

The presence of the films resulting from the first and/or the second coating1050,1060may enhance the overall strength of the resulting treatment device. Specifically, layered structure(s) of the films formed by the first and second coatings1050,1060, which are bonded to the first and second major surfaces1211,1212of the multi-directional plate1210, provide added mechanical integrity to the resulting treatment device.

Beyond achieving the baseline flexibility to conform to curvature of the eye, the addition of the first and/or second coatings1050,1060may provide a mechanism that allows the overall treatment device to match the elastic modulus of surrounding tissues (e.g., conjunctival and scleral tissues) to maximize biocompatibility or biointegration. Findings in brain implant research confirm that the flexibility of implants in soft tissue improves compliance of the implant with microscale movements of surrounding tissue and reduces tissue displacement and trauma as well as facilitates implantation of the treatment device.

Treatment Device Insertion Embodiment

FIG.6is a diagram of the treatment device1implanted between conjunctival tissue602and scleral tissue604of a patient's eye600, according to an example embodiment of the present disclosure. The treatment device1is a biocompatible ocular implant that includes a thin, flexible plate to facilitate safe, comfortable, and effective treatment. The treatment device1includes a plate structure200having a plurality of channels232. The example channels232are configured to facilitate the draining of accumulated aqueous in the anterior chamber606of the eye600to a pocket (bleb)608that is located between the conjunctival tissue602and scleral tissue604. This enables intraocular pressure from the accumulation of the aqueous in the anterior chamber606to be reduced. The removed aqueous in the pocket608is gradually reabsorbed by surrounding tissue, which enables further accumulating aqueous to be removed from the anterior chamber606. This continuous draining of aqueous (e.g., glaucoma drainage) lowers pressure within the eye600and protects the optic nerve. The redundant channels232of the plate structure200prevent single-end clogging by scar tissue. Further, the thin profile of the plate structure200hinders tissue erosion.

FIG.6also shows the plate structure200including a notch610along a perimeter. While the notch610is shown on a lower left section of the plate structure200, it should be appreciated that the notch610may be located at any location of the perimeter. Further, while one notch610is shown, the plate structure200may include two or more notches. The notch610is configured to facilitate proper installation and placement of the plate structure200within a patient's eye. The notch610may be indicative as to whether the channels232of the plate structure200are aligned upwards or downwards. The notch610accordingly provides confirmation to a clinician that the plate structure200is properly orientated.

FIG.7is a diagram of an example insertion procedure700for the treatment device1, according to an example embodiment of the present disclosure. It should be appreciated that the example procedure700is exemplary, and that additional, fewer, or different steps may be performed, as described below in relation to different types of insertion tools. At Event (1), a small incision702is made in the conjunctival tissue602. The incision702may have a length between 1 mm and 5 mm, preferably around 3 mm and may be made via a scalpel. At Event (2), a pocket608is formed between the conjunctival tissue602and scleral tissue604. In some embodiments, the pocket608is formed using the insertion tool described herein.

At Event (3), the treatment device1is brought into proximity of the patient's eye600. The treatment device1may include an extension portion250with excess material that enables its length to be customized for reaching the anterior chamber606of the patient's eye600. In some embodiments, the treatment device1is furled or otherwise placed into an insertion position around or within an insertion tool. At Event (4), the insertion tool is inserted into the pocket608and unfurls or otherwise deploys the treatment device (1). The insertion tool is then removed leaving the treatment device unfurled within the pocket608.

At Event (5), a small incision704is made into the scleral tissue using a scalpel. The incision704may have a diameter or width between 1 mm and 4 mm, preferably around 2 mm. At Event (6), a tool, such as tweezers or pliers, grabs an end of the extension portion250to create tension. A blunt tool706is then used in Event (7) to push at least a portion of the extension portion250into the scleral incision704. At Event (8), any excess of the extension portion250is removed or trimmed. Then at Event (9), the remaining extension portion250is pushed into the anterior chamber606, thereby fully inserting the treatment device1. In some embodiments, the incisions702and704may be sutured or otherwise closed.

FIGS.8A and8Bare diagrams showing how an insertion tool800is used to insert the treatment device1, according to an example embodiment of the present disclosure. At shown in the illustrated example, the insertion device800is a scissoring mechanism that has a first arm804and a second arm804connected together at a pivot point806. A first end808(e.g., a first prong) of the first arm802has an L-shape to interlock with a first end810(e.g., a second prong) of the second arm804(shown in a cross-section diagram of the insertion device800). When the first end808of the first arm802is interlocked with the first end810of the second arm804, the insertion tool800has an ovular profile with a diameter of around 2 to 3 mm, which enables insertion through the incision702. Opposite ends of the first arm802and the second arm804may include handles to enable a clinician to rotate the arms802and804about the pivot point806.

At Event (4A) ofFIG.8A(corresponding to Event (4) ofFIG.7), the treatment device1is wrapped or furled around the closed ends808and810of the arms802and804. The ovular shape of the ends808and810facilitates the folding of the treatment device1around the insertion tool800. At Event (4B), the insertion tool800is inserted through the incision702into the pocket608. During this action, the arms802and804are kept in a closed position to keep the treatment device1furled. In this example, the extension portion250has an arrow-shape with sides that extend past a length of the incision702. The shape and width of the extension portion250provides stop that prevents the insertion tool800from being inserted too far into the pocket608.

At Event (4C) after a leading section of the insertion tool800is fully inserted, the arms802and804are rotated about the pivot point806. This causes the ends808and810to separate from each other, thereby causing the treatment device1to begin to unfurl. At Event (4D), the arms802and804are further rotated to a maximum rotation point. This causes the treatment device1to completely unfurl to a flat plate. As shown, the ends808and810include surfaces that are flat, which causes the treatment device1to be spread flat. Further, edges of the ends808and810may be blunt to provide for dissection of the conjunctival tissue602and scleral tissue604to further form the pocket608. Also, as shown inFIG.8, the insertion tool800is inserted into the incision702close enough to the pivot point806such that rotation of the arms802and804does not exceed a length of the incision702.

At Event (4E), after the treatment device1is spread into a flat plate, the arms802and804are rotated back to a closed position. This causes the ends808and810to reengage such that the separate L-profiles interlock to form an ovular profile, as shown in Event (4F) when the arms802and804are fully in a closed position. At Event (4G), the insertion tool800is removed from the pocket608through the incision702, leaving the treatment device1in place. The use of the insertion tool800enables a treatment device1with a diameter wider than an incision702to be placed into a pocket708between the conjunctival tissue602and scleral tissue604.

FIG.9is a diagram of an alternative insertion tool900, according to an example embodiment of the present disclosure. In this example, the first arm802includes a first prong902and the second arm804includes a second prong904. In this example, the prongs902and904each have a circular profile with a diameter of about 1.3 mm. Together, the insertion tool900, including the prongs902and904in a closed position, has a width of about 2.5 mm, which is less than the 3 mm incision702. In a closed position, the treatment device1is wrapped around the prongs902and904.

The example prongs902and904in this embodiment have a triangular shape with a rounded leading edge, a radiused edge, or a blunted leading edge. Since a base of the triangular side moves less when the arms802and804are opened, the extra material still spreads over the treatment device1. By contrast, the leading edge of the prongs902and904have more movement that cover the width of the treatment device1, which enables the prongs902and904to have a smaller width in this area. In other words, a width of the prongs902and904is tapered to account for increased amounts of coverage for sections of the prongs902and904further from the pivot point806. In this embodiment, the prongs902and904are shaped to match a shape of the unfurled treatment device1. In another example, the prongs902and904are taped to match a treatment device1that has a wedge-shape or sides that are not parallel. Such a configuration enables the prongs902and904to bluntly dissect the subconjunctival pocket or space and cause the treatment device1to unfurl and lay flat.

In some embodiments, the prongs902and904are configured to expand to a predefined geometry that is greater than a surface of the unfurled treatment device1. Having the prongs902and904expand to a predefined geometry that is greater than the treatment device1facilitates aqueous absorption and/or makes the treatment device1easier to unfurl. The prongs902and904may expand a distance that is at least 0.5 mm greater than a width of the treatment device1, for example.

In some embodiments, the prongs902and904are inserted inside of a cannula (not shown) for insertion through the incision702. In these embodiments, the cannula is removed through the incision702, thereby enabling the arms802and804to move to an open position, causing the prongs902and904to spread the treatment device1within the pocket608. The use of the cannula prevents the arms802and804from inadvertently opening during insertion of the tool900. Further, the cannula may prevent the prongs902and904and/or the wrapped treatment device1from snagging edges of the conjunctival tissue602and scleral tissue604at the incision location during insertion. Further, the cannula helps prevent the treatment device1from being dislodged during delivery into the pocket608.

FIG.10is a diagram of a procedure1000for inserting the treatment device1using another type of insertion tool1002, according to an example embodiment of the present disclosure. At Event (1), a cutting tool pierces the conjunctival tissue of a patient's eye with a sharp end. The tool opens, causing sharp edges to form an incision1004. At Event (2), a fluid is added to an anterior chamber of the patient's eye to inflate the cornea. At Event (3), another tool makes an incision into the scleral tissue for access into the anterior chamber.

At Event (4), the insertion tool1002with a furled treatment device1is inserted into the incision1004. In this example, the insertion tool1002is sliding mechanism with blunt, slightly curved prongs. Compared to the prongs902and904ofFIG.9, the prongs ofFIG.10are wider but still able to fit through the incision1004. Here, the treatment device1is clasped between the two prongs. A top prong faces the conjunctiva tissue and is configured to slide forward to push the treatment device1off of the bottom prong, thereby sliding the treatment device1into the sub-conjunctival space or pocket608. After the treatment device1is pushed off of the prongs, the prongs are used in a sweeping motion to tamp down the treatment device1in the pocket608, thereby ensuring the treatment device1lays flat. Event (5) shows the treatment device1lying flat within the pocket608with the insertion tool1002removed.

At Event (6), another tool grasps the extension portion250of the treatment device1for placement through the second incision into the anterior chamber, thereby forming a fluid pathway to the pocket608to relieve pressure within the anterior chamber. At Event (7) one or more sutures are placed to close the incisions. At Event (8), the sutures are completed, thereby completing the procedure1000to insert the treatment device1.

FIG.11is a diagram of another insertion tool1100, according to an example embodiment of the present disclosure. In this example, the insertion tool1100includes a blunt, 1.5 mm wide prong. The example prong is configured to guide the treatment device1through a scleral incision into an anterior chamber of a patient's eye. In some embodiments, the insertion tool1100may be slightly curved and have a broad spatula-like prong that is used like a sheath glide to slide the treatment device1into the sub-conjunctival space or pocket608. The insertion tool1100may be moved in a side-to-side sweeping motion across the treatment device1to ensure the treatment device1lays flat. In some embodiments, the prong of the insertion tool1100may have a surface area that is between 5 mm×10 mm to 8 mm×11 mm. In these examples, a longer or wider incision may be needed.

FIG.12is a diagram of another insertion tool1200, according to an example embodiment of the present disclosure. The insertion tool1200includes an expandable mechanism that includes a first arm1202and a second arm1204. The first and second arms1202and1204are bent inward to cross each other. A first end1206of the first arm1202contacts a second end1208of the second arm1204when the insertion tool1200is in a resting position. The first end1206and the second end1208may include flat surfaces that enable insertion through an incision made in a patient's eye to a sub-conjunctival space or pocket. The first end1206and the second end1208together have a width that is less than 5 mm, for example, and a height that is less than 1 mm, for example.

Opposite ends of the first and second arms1202and1204are connected together. Additionally, the arms1202and1204are angled or bent with respect to each other. The connection and angling of the arms1202and1204creates a spring force that pushes the ends1206and1208together. An operator may apply pressure by pressing against the spring force by pressing the first arm1202towards the second arm1204. The applied pressure causes the first end1206and the second end1208to separate in opposite directions. This movement in opposite directions causes a furled treatment device1to be opened into a flat plate.

In an example, the treatment device1may be furled around the first end1206and the second end1208of the insertion tool1200. After insertion, pressure is applied to the arms1202and1204, causing the ends1206and1208to move apart and unfurl the treatment device1. After unfurling the treatment device1, pressure on the arms1202and1204is relaxed, enabling the ends1206and1208to come back together. The ends1206and1208may then be removed from sub-conjunctival space or pocket.

It should be appreciated that the above insertion tools may be coated with a hydrophobic coating, which may include Teflon, to lower friction between the tools and facilitate their insertion/removal from a surgical site.

Treatment Device Reinforcement Embodiment

In some embodiments, the plate structure200of the treatment device1includes one or more holes or apertures for reinforcement. As described above, the treatment device1may be foldable for insertion. However, after unfolding, the treatment device1may retain some internal compressive forces that cause at least edges to bend. To prevent any bending, one or more holes or apertures1300may be added, as shown inFIG.13.

The example holes1300may be formed via a laser during a manufacturing process. A ring of thicker parylene or alumina may be placed around an edge of the holes1300for reinforcement. Tissue glue may then be applied on one side and/or within the holes1300. The glue hydrates upon the treatment device1being inserted/implanted into a patient's eye. Once hydrated, the glue anchors the treatment device1to the scleral tissue in the sub-conjunctival space or pocket608, thereby preventing bending or lateral movement.

CONCLUSION