Intraocular drainage valve

Abstract

Intraocular drainage valves are provided that include a housing having a fluid entry / exit portion and a sealing portion. The fluid entry / exit portion includes an inlet tube port, a fluid entry reservoir (813), an outlet tube port (816), a fluid exit reservoir and a membrane base (817) having a sealing surface (819) and defining a valve portion of the fluid entry reservoir. A sealing portion (814) includes a bar (822) extending towards the membrane base (817). A valve membrane (850) is disposed between the valve portion of the fluid entry reservoir (813) and the bar (822) with a first portion of the valve membrane pressed against the bar (822). A flap portion (853) of the valve membrane (850) seals against the sealing surface (819) at a first fluid pressure and flexes away from a portion of the sealing surface (819) at a second fluid pressure. Methods of operating intraocular drainage valves and intraocular drainage assemblies are also provided.

Description

INTRAOCULAR DRAINAGE VALVECROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 639,196, filed April 26, 2024, entitled “INTRAOCULAR DRAINAGE VALVE” and U.S. Provisional Patent Application No. 63 / 725,669, filed November 27, 2024, entitled “INTRAOCULAR DRAINAGE VALVE,” the entire contents of which are incorporated herein by reference.TECHNICAL FIELD

[0002] The present disclosure generally relates to an intraocular drainage device, in particular an intraocular drainage valve to drain aqueous humour from the eye.BACKGROUND

[0003] Aqueous humour typically drains from the anterior chamber of the eye via the trabecular meshwork at the edge of the cornea. In some circumstances, overproduction of aqueous humour or reduced drainage of aqueous humour can increase intraocular pressure which can cause discomfort and / or damage the optic nerve. Intraocular drainage devices are used to provide increased drainage of aqueous humour from the anterior chamber, particularly for glaucoma patients. However, some typical intraocular drainage devices allow pressure within the eye (e.g., intraocular pressure (IOP)) to drop to a dangerously low pressure, thus allowing hypotony during drainage of aqueous humour. Also, some typical intraocular drainage devices have a tube with a very small diameter that is subject to clotting or clogging due to the body healing after insertion of the intraocular drainage device and / or debris in the aqueous humour. Thus, some typical intraocular drainage devices have large diameter drainage tubes in an attempt to mitigate the clogging issue. In addition, typical drainage tubes provide a simple fluid pathway that allows for fluid backflow into the eye. Accordingly, it is desirable to provide an intraocular drainage device to prevent IOP from dropping to a dangerously low pressure and preventing hypotony during drainage of aqueous humour. It is also desirable having a valve that can clear clots or debris to restore desirable fluid flow without requiring surgical intervention, that can prevent or mitigate backflow of fluid or debris into the eye and that can be manufactured easily and at low cost.SUMMARY

[0004] One or more embodiments of the disclosure include an intraocular drainage valve includes a housing having a fluid entry portion having an inlet tube port, a fluid entry reservoir and a sealing surface disposed around a perimeter of the fluid entry reservoir, and a fluid exit portion having an exit port and a bar. The intraocular drainage valve also includes a valve membrane disposed between the fluid entry reservoir and the bar with a first portion of the valve membrane pressed against the bar, wherein the valve membrane is configured to seal against the sealing surface to seal the fluid entry reservoir at a first fluid pressure and for a second portion of the valve membrane not pressed against the bar to flex away from a portion of the sealing surface adjacent the fluid entry reservoir at a second fluid pressure.

[0005] One or more embodiments of the disclosure include a method of operating an intraocular drainage valve. The method includes receiving, by an inlet tube port of a fluid entry portion of a housing of the intraocular drainage valve, ocular fluid from an eye flowing through a drainage tube coupled to the inlet tube port; receiving, from the inlet tube port, the ocular fluid into a fluid entry reservoir of the fluid entry portion; engaging a first surface of a valve membrane against a sealing surface of the fluid entry portion, the sealing surface disposed around a perimeter of the fluid entry reservoir; engaging a second surface of the valve membrane against a bar of a fluid exit portion of the housing of the intraocular drainage valve; preventing, by the valve membrane, the ocular fluid from flowing from the fluid entry reservoir to an exit port of the fluid exit portion at a first fluid pressure of the ocular fluid in the fluid entry reservoir; flexing away from the sealing surface a portion of the valve membrane not engaged against the bar at a second fluid pressure of the ocular fluid in the fluid entry reservoir that is greater than the first fluid pressure; receiving, by the exit port, ocular fluid flowing from the fluid entry reservoir and past the flexed portion of the valve membrane; and discharging, from the exit port, the ocular fluid external to the intraocular drainage valve.

[0006] One or more embodiments of the disclosure include an intraocular drainage valve having a fluid entry portion that includes an inlet tube port, an entry port fluidly coupled to the inlet tube port and a valve membrane comprising an outer shell of the fluid entry portion. The intraocular drainage valve also includes a fluid exit portion that includes a fluid reservoir fluidly coupled to the entry port of the fluid entry portion and a sealing surface disposed around a portion of a perimeter of the sealing surface, wherein the valve membrane is disposed around the fluid reservoir and the sealing surface. The valve membrane is configured to seal againstthe sealing surface to seal the fluid reservoir at a first fluid pressure from fluid within the fluid reservoir and a portion of the valve membrane is configured to flex away from the sealing surface adjacent the fluid reservoir at a second fluid pressure from fluid within the fluid reservoir greater than the first fluid pressure.BRIEF DESCRIPTION OF THE DRAWINGS

[0007] The accompanying drawings, which are included to provide further understanding of the disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments of the disclosure and together with the description serve to explain the principles of the disclosure.

[0008] FIG. 1 depicts a perspective view of an example intraocular drainage valve, according to aspects of the disclosure.

[0009] FIG. 2 depicts an exploded perspective view of the intraocular drainage valve of FIG. 1, according to aspects of the disclosure.

[0010] FIG. 3 depicts another exploded perspective view of the intraocular drainage valve of FIG. 1, according to aspects of the disclosure.

[0011] FIG. 4 depicts a cross-sectional side view of the intraocular drainage valve of FIG. 1, according to aspects of the disclosure.

[0012] FIG. 5 depicts a cross-sectional front perspective view of the intraocular drainage valve of FIG. 1, according to aspects of the disclosure.

[0013] FIG. 6 depicts a perspective view of an example intraocular drainage valve, according to aspects of the disclosure.

[0014] FIG. 7 depicts an exploded perspective view of the intraocular drainage valve of FIG. 6, according to aspects of the disclosure.

[0015] FIG. 8 depicts a cross-sectional side view of the intraocular drainage valve of FIG. 6, according to aspects of the disclosure.

[0016] FIG. 9 depicts an exploded perspective view of an intraocular drainage valve, according to aspects of the disclosure.

[0017] FIG. 10 depicts another exploded perspective view of the intraocular drainage valve of FIG. 9, according to aspects of the disclosure.

[0018] FIG. 11 depicts a cross-sectional side view of the intraocular drainage valve of FIG. 9, according to aspects of the disclosure.

[0019] FIG. 12 depicts a cross-sectional front perspective view of the intraocular drainage valve of FIG. 9, according to aspects of the disclosure.

[0020] FIG. 13 depicts a perspective view of an intraocular drainage valve coupled to an ocular implant disposed on an eye, according to aspects of the disclosure.

[0021] FIG. 14 depicts a perspective view of an intraocular drainage valve coupled to an ocular implant disposed on an eye, according to aspects of the disclosure.

[0022] FIG. 15 depicts a perspective view of an example intraocular drainage valve, according to aspects of the disclosure.

[0023] FIG. 16 depicts an exploded perspective view of the intraocular drainage valve of FIG. 15, according to aspects of the disclosure.

[0024] FIG. 17 depicts another exploded perspective view of the intraocular drainage valve of FIG. 15, according to aspects of the disclosure.

[0025] FIG. 18 depicts a cross-sectional side view of the intraocular drainage valve of FIG. 12, according to aspects of the disclosure.

[0026] FIG. 19 depicts a perspective view of an example intraocular drainage valve, according to aspects of the disclosure.

[0027] FIG. 20 depicts an exploded perspective view of the intraocular drainage valve of FIG. 19, according to aspects of the disclosure.

[0028] FIG. 21 depicts a cross-sectional side view of the intraocular drainage valve of FIG. 19, according to aspects of the disclosure.

[0029] FIGS. 22 A to 22C depict schematic views of an intraocular drainage valve during assembly, according to aspects of the disclosure.

[0030] FIG. 23 A depicts an exploded perspective view of an example intraocular drainage valve, according to aspects of the disclosure.

[0031] FIG. 23B depicts an exploded perspective view of the intraocular drainage valve of FIG. 23 A, according to aspects of the disclosure.

[0032] FIGS. 23C and 23D depict cross-sectional perspective and side views of the intraocular drainage valve of FIG. 23 A, according to aspects of the disclosure.

[0033] FIGS. 23E and 23F depict perspective views of first and second housing portions of the intraocular drainage valve of FIG. 23 A, according to aspects of the disclosure.

[0034] FIGS. 23G to 231 depict cross-sectional perspective views of the intraocular drainage valve of FIG. 23 A, according to aspects of the disclosure.

[0035] FIG. 24A depicts a perspective view of an intraocular drainage valve coupled to an ocular implant, according to aspects of the disclosure.

[0036] FIG. 24B depicts a perspective view of the intraocular drainage valve coupled to an ocular implant of FIG. 24A with the top removed, according to aspects of the disclosure.

[0037] FIG. 24C depicts a cross-sectional side view of the intraocular drainage valve coupled to an ocular implant of FIG. 24A, according to aspects of the disclosure.

[0038] FIG. 24D depicts a perspective view of an intraocular drainage valve coupled to an ocular implant, according to aspects of the disclosure.

[0039] FIG. 25 depicts a cross-sectional perspective view of an example intraocular drainage valve, according to aspects of the disclosure.DETAILED DESCRIPTION

[0040] The detailed description set forth below describes various configurations of the subject technology and is not intended to represent the only configurations in which the subject technology may be practiced. The detailed description includes specific details for the purpose of providing a thorough understanding of the subject technology. Accordingly, dimensions are provided in regard to certain aspects as non-limiting examples. However, it will be apparent to those skilled in the art that the subject technology may be practiced without these specificdetails. In some instances, well-known structures and components are shown in block diagram form in order to avoid obscuring the concepts of the subject technology.

[0041] It is to be understood that the present disclosure includes examples of the subject technology and does not limit the scope of the appended claims. Various aspects of the subject technology will now be disclosed according to particular but non-limiting examples. Various embodiments described in the present disclosure may be carried out in different ways and variations, and in accordance with a desired application or implementation.

[0042] Normal eye pressure ranges from 12-22 mm Hg for people without glaucoma. As discussed above, for patients with glaucoma overproduction of aqueous humour or reduced drainage of aqueous humour can increase intraocular pressure (IOP) which can cause discomfort and / or damage the optic nerve. Thus, for glaucoma patients a typical biological aqueous humour flow rate may have an ideal pressure drop in a range around 12 mm of mercury. If the IOP is too low (e.g., less than 6 mm of mercury), there is a danger of becoming hypotonous where the eye structure essentially falls apart and may result in blindness in that eye. On the other hand, if the IOP is consistently too high (e.g., more than 14 mm of mercury) or has spikes above 18 mm of mercury, there is also a danger of deterioration and blindness in the eye. Accordingly, an IOP in the range of 8-14 mm of mercury is desirable to maintain optimal eye health.

[0043] For eye diseases such as Glaucoma, for example, underdrainage of the aqueous humour increases the pressure into the undesirable high pressure ranges discussed above. An intraocular drainage device (e.g., drainage tube) may be used to relieve this pressure by providing a tube that improves aqueous humour flow. Thus, it is very desirable that the drainage tube maintain the desired aqueous humour flow. However, if the drainage tube allows IOP to drop to a dangerously low pressure, the eye may become hypotonous during drainage of aqueous humour. Also, if the drainage tube becomes partially or wholly blocked due to clotting or debris, the aqueous humour flow within the eye is reduced, thereby increasing the pressure. Further, if there is a backpressure or reverse flow of fluid through the tube into the eye, the pressure in the eye may also increase. To overcome the hypotony, clogging and backflow issues with drainage tubes, the present disclosure provides for intraocular drainage valves having check valve and self-clearing functions. The valve provides a check function by requiring a threshold pressure (e.g., cracking pressure) from the fluid draining from the tube in order to allow fluid flow through the valve, thus preventing over drainage and / or hypotony.The valve also responds to a build-up in pressure due to increased ocular pressure and / or clotting or debris by providing an increased fluid pathway (e.g., open a valve, further open a somewhat opened valve), which in turn provides increased fluid flow through the drainage tube, thus restoring the increased aqueous humour pressure to the desired pressure range.

[0044] Referring now in more detail to the drawings in which like reference numerals refer to like or corresponding elements among the several views, there is shown in FIG. 1 an intraocular drainage valve 100 coupled to a drainage tube 180. The intraocular drainage valve 100 may have a curved profile corresponding to a curvature of an eye 190 (see FIG. 13).

[0045] According to aspects of the disclosure, as shown in FIGS. 2-5, the intraocular drainage valve 100 includes a housing 110 having a fluid entry portion 112, a fluid exit portion 114 and a tube port 116. The tube port 116 is configured to be coupled to the tube 180, where the tube 180 may be inserted into an eye 190 to drain aqueous humour. The fluid entry portion 112 defines a fluid entry reservoir 113 and the fluid exit portion 114 defines a fluid exit reservoir 115. The fluid entry reservoir 113 and the fluid exit reservoir 115 are separated by a flexible valve membrane 150 that is disposed on and / or coupled to a bar 117 of the fluid exit portion 114. The valve membrane 150 is formed of any suitable flexible material, such as silicone and the like. A sealing surface 119 of the fluid entry portion 112 may surround a portion of the fluid entry reservoir 113 and provide a seal against the valve membrane 150.

[0046] For example, as shown in FIG. 3, the bar 117 extends centrally across the width of the fluid exit reservoir 115 and the valve membrane 150 rests on top of the bar 117 such that the valve membrane 150 is bisected by the bar 117. The fluid exit portion 114 has one or more exit ports 118 disposed between the fluid exit reservoir 115 and the exterior of the intraocular drainage valve 100. The fluid entry portion 112 has an entry port 111 disposed between the tube port 116 and the fluid entry reservoir 113, as shown in FIG. 4.

[0047] In use, the tube port 116 may be coupled to the tube 180 that has been inserted into the eye 190 to drain a fluid such as aqueous humour, such as by the tube port 116 being inserted into an end of the tube 180 and held in place by a friction fit, an adhesive and / or a solvent. As fluid pressure increases in the eye 190, fluid drains out of the eye 190 through the tube 180 and into the tube port 116, which then flows through the entry port 111 and into the fluid entry reservoir 113. Here, the sealing surface 119 of the fluid entry portion 112 is flush against avalve membrane surface 152 of the valve membrane 150, thus providing a fluid seal around the fluid entry reservoir 113 adjacent to the valve membrane 150.

[0048] As the fluid flows into the fluid entry reservoir 113 it increases pressure on the valve membrane 150, which is balanced on the bar 117 in a pressure neutral position, the valve membrane 150 separating the fluid entry reservoir 113 from the fluid exit reservoir 115. When the pressure (e.g., fluid pressure) on the valve membrane 150 exceeds a threshold (e.g., cracking pressure), one or both ends of the valve membrane 150 flex away from the sealing surface 119 and into the fluid exit reservoir 115, thus allowing the fluid in the fluid entry reservoir 113 to flow into the fluid exit reservoir 115 and out through the exit ports 118.

[0049] When the fluid pressure against a valve membrane surface 154 of the valve membrane 150 in the fluid exit reservoir 115 is the same as the fluid pressure in the fluid entry reservoir 113 against the valve membrane surface 152, the ends of the valve membrane 150 flex back against the sealing surface 119 and into the pressure neutral position, again separating the fluid entry reservoir 113 from the fluid exit reservoir 115. This equalizing pressure may be caused when the fluid flow from the eye 190 through the inlet tube 180 lessens or stops and / or by a preload or bias of the valve membrane 150 towards the sealing surface 119. The valve membrane 150 may thus flex from the pressure neutral position in increasing levels of flex into the fluid exit reservoir 115 as the fluid pressure on the valve membrane surface 152 adjacent the fluid entry reservoir 113 increases.

[0050] Accordingly, the valve membrane 150 may flex back and forth to any position between the sealed pressure neutral position (e.g., no fluid flow past the valve membrane 150) and a fully flexed position (e.g., full fluid flow past the valve membrane 150) based on changes in the opposing fluid pressures against the valve membrane surface 152 and the valve membrane surface 154 and / or biasing properties of the valve membrane 150. The material composition of the valve membrane 150 may be selected or formed to provide a specific amount of stiffness, bias and / or flexibility for the valve membrane 150, thus providing for a desired amount of flex of the valve membrane 150 for a particular pressure exerted on the valve membrane surface 152. Here, a valve membrane 150 having a stiffer and less flexible material form and / or stronger biasing / preloading properties towards the sealing surface 119 would require a higher cracking pressure on the valve member 150 to allow fluid flow from the fluid entry reservoir 113 past the valve membrane 150 and into the fluid exit reservoir 115 thanwould a valve membrane 150 having a more flexible material form and / or weaker biasing / preloading properties.

[0051] According to aspects of the disclosure, as shown in FIGS. 6-8, an intraocular drainage valve 200 includes a housing 210 having a fluid entry portion 212, a fluid exit portion 214, an inlet tube port 216 and an outlet tube port 218. The inlet tube port 216 is configured to be coupled to an inlet tube 180, where the inlet tube 180 may be inserted into an eye 190 to drain aqueous humour. The fluid entry portion 212 defines a fluid entry reservoir 213 and the fluid exit portion 214 defines a fluid exit reservoir 215. The fluid entry reservoir 213 and the fluid exit reservoir 215 are separated by a valve membrane 250 that is disposed on and / or coupled to a bar 217 of the fluid exit portion 214. The valve membrane 250 is formed of any suitable flexible material, such as silicone and the like. A sealing surface 219 of the fluid entry portion 212 may surround a portion of the fluid entry reservoir 213 and provide a seal against the valve membrane 250. The sealing surface 219 may include a fluid exit channel 223 disposed adjacent the outlet tube port 218.

[0052] For example, as shown in FIG. 8, the bar 217 extends centrally across a width in the center of the fluid exit reservoir 215 and the valve membrane 250 rests on top of the bar 217 such that the valve membrane 250 is bisected by the bar 217. The fluid exit reservoir 215 of the fluid exit portion 214 is fluidly coupled to the outlet tube port 218 to provide a fluid flow path to the exterior of the intraocular drainage valve 200. The fluid entry portion 212 has an entry port 211 disposed between the inlet tube port 216 and the fluid entry reservoir 213, as shown in FIG. 8.

[0053] The fluid exit portion 214 includes one or more mating protrusions 221 disposed adjacent to the fluid exit reservoir 215 at the inlet tube port 216 end of the housing 210. The fluid entry portion 212 includes one or more mating receptacles 222 correspondingly disposed at the inlet tube port 216 end of the housing 210. The mating protrusions 221 extend into and mate with the mating receptacles 222 to provide accurate alignment of the coupling between the fluid exit portion 214 and the fluid entry portion 212 forming the housing 210. The mating protrusions 221 also provide a hard stop for the valve membrane 250 and are configured to prevent movement (e.g., sliding) of the valve membrane 250 towards the inlet tube port 216 end of the housing 210 and to provide accurate alignment of the valve membrane 250 between the fluid exit reservoir 215 and the fluid entry reservoir 213. In aspects of the disclosure, the mating protrusions 221 may be on the fluid entry portion 212 and the mating receptacles 222on the fluid exit portion 214. In aspects of the disclosure, any suitable mating structures may be disposed on the fluid entry portion 212 and the fluid exit portion 214, such as ribs and corresponding channels, for example.

[0054] In use, the inlet tube port 216 may be coupled to the inlet tube 180 that has been inserted into the eye 190 to drain a fluid such as aqueous humour. Here, the inlet tube port 216 is inserted into an end of the inlet tube 180 and held in place by a friction fit, an adhesive and / or a solvent. As fluid pressure increases in the eye 190, fluid drains out of the eye 190 through the inlet tube 180 and into the inlet tube port 216, which then flows through the entry port 211 and into the fluid entry reservoir 213. Here, the sealing surface 219 of the fluid entry portion 212 is flush against a valve membrane surface 252 of the valve membrane 250, thus providing a fluid seal around the fluid entry reservoir 213 adjacent to the valve membrane 250.

[0055] As the fluid flows into the fluid entry reservoir 213 it increases pressure on the valve membrane 250, which is balanced on the bar 217 in a pressure neutral position, the valve membrane 250 separating the fluid entry reservoir 213 from the fluid exit reservoir 215. When the pressure (e.g., fluid pressure) on the valve membrane 250 exceeds a threshold (e.g., cracking pressure), one or both ends of the valve membrane 250 flex away from the sealing surface 219 and into the fluid exit reservoir 215, thus allowing the fluid in the fluid entry reservoir 213 to flow into the fluid exit reservoir 215 and out through the outlet tube port 218.

[0056] When the fluid pressure against a valve membrane surface 254 of the valve membrane 250 in the fluid exit reservoir 215 is the same as the fluid pressure in the fluid entry reservoir 213 against the valve membrane surface 252, the ends of the valve membrane 250 flex back against the sealing surface 219 and into the pressure neutral position, again separating the fluid entry reservoir 213 from the fluid exit reservoir 215. This equalizing pressure may be caused when the fluid flow from the eye 190 through the inlet tube 180 lessens or stops and / or by a preload or bias of the valve membrane 250 towards the sealing surface 219. The valve membrane 250 may thus flex from the pressure neutral position in increasing levels of flex into the fluid exit reservoir 215 as the fluid pressure on the valve membrane surface 252 adjacent the fluid entry reservoir 213 increases.

[0057] Accordingly, the valve membrane 250 may flex back and forth to any position between the sealed pressure neutral position (e.g., no fluid flow past the valve membrane 250) and a fully flexed position (e.g., full fluid flow past the valve membrane 250) based on changesin the opposing fluid pressures against the valve membrane surface 252 and the valve membrane surface 254 and / or biasing properties of the valve membrane 250. The material composition of the valve membrane 250 may be selected or formed to provide a specific amount of stiffness, bias and / or flexibility for the valve membrane 250, thus providing for a desired amount of flex of the valve membrane 250 for a particular pressure exerted on the valve membrane surface 252. Here, a valve membrane 250 having a stiffer and less flexible material form and / or stronger biasing / preloading properties towards the sealing surface 219 would require a higher cracking pressure on the valve member 250 to allow fluid flow from the fluid entry reservoir 213 past the valve membrane 250 and into the fluid exit reservoir 215 than would a valve membrane 250 having a more flexible material form and / or weaker biasing / preloading properties.

[0058] According to aspects of the disclosure, as shown in FIGS. 9 to 12, an intraocular drainage valve 300 includes a housing 310 having a fluid entry portion 312, a fluid exit portion314, and inlet tube port 316 and an outlet tube port 318. The inlet tube port 316 is configured to be coupled to an inlet tube 180, where the inlet tube 180 may be inserted into an eye 190 to drain aqueous humour. The fluid entry portion 312 defines a fluid entry reservoir 313 and the fluid exit portion 314 defines a fluid exit reservoir 315. The fluid entry reservoir 313 and the fluid exit reservoir 315 are separated by a valve membrane 350 that is disposed on and / or coupled to a bar 317 of the fluid exit portion 314, where bar 317 is L-shaped. The valve membrane 350 is formed of any suitable flexible material, such as silicone and the like. A sealing surface 319 of the fluid entry portion 312 may surround a portion of the fluid entry reservoir 313 and provide a seal against the valve membrane 350. The sealing surface 319 may include a fluid exit channel 323 disposed adjacent the outlet tube port 318.

[0059] For example, as shown in FIG. 9, the bar 317 has a first leg 317a that extends across an end (e.g., width) of the fluid exit reservoir 315 adjacent the inlet tube port 316 and a second leg 317b that extends along a portion of the side (e.g., lengthwise) of the fluid exit reservoir315, the two legs 317a, 317b forming an L-shape. The valve membrane 350 rests on top of the bar 317 such that the valve membrane 350 is supported along one end and one side by the bar 317. The fluid exit reservoir 315 of the fluid exit portion 314 is fluidly coupled to the outlet tube port 318 to provide a fluid flow path to the exterior of the intraocular drainage valve 300. The fluid entry portion 312 has an entry port 311 disposed between the inlet tube port 316 and the fluid entry reservoir 313, as shown in FIG. 11.

[0060] In aspects of the disclosure, the components and structures of the intraocular drainage valve 200 may be the same as the components and structures of the intraocular drainage valve 300, with the exception of the structure of the bar 217 versus the structure of the bar 317 and the coupling / interaction of the bar 217, 317 with the corresponding valve member 250, 350. In aspects of the disclosure, any suitable bar / valve membrane coupling structure may be used.

[0061] The fluid exit portion 314 includes one or more mating protrusions 321 disposed adjacent to the fluid exit reservoir 315 at the inlet tube port 316 end of the housing 310. The fluid entry portion 312 includes one or more mating receptacles 322 correspondingly disposed at the inlet tube port 316 end of the housing 310. The mating protrusions 321 extend into and mate with the mating receptacles 322 to provide accurate alignment of the coupling between the fluid exit portion 314 and the fluid entry portion 312 forming the housing 310. The mating protrusions 321 also provide a hard stop for the valve membrane 350 and are configured to prevent movement (e.g., sliding) of the valve membrane 350 towards the inlet tube port 316 end of the housing 310 and to provide accurate alignment of the valve membrane 350 between the fluid exit reservoir 315 and the fluid entry reservoir 313. In aspects of the disclosure, the mating protrusions 321 may be on the fluid entry portion 312 and the mating receptacles 322 on the fluid exit portion 314. In aspects of the disclosure, any suitable mating structures may be disposed on the fluid entry portion 312 and the fluid exit portion 314, such as ribs and corresponding channels, for example.

[0062] In use, the inlet tube port 316 may be coupled to the inlet tube 180 that has been inserted into the eye 190 to drain a fluid such as aqueous humour. Here, the inlet tube port 316 is inserted into an end of the inlet tube 180 and held in place by a friction fit, an adhesive and / or a solvent. As fluid pressure increases in the eye 190, fluid drains out of the eye 190 through the inlet tube 180 and into the inlet tube port 316, which then flows through the entry port 311 and into the fluid entry reservoir 313. Here, the sealing surface 319 of the fluid entry portion 312 is flush against a valve membrane surface 352 of the valve membrane 350, thus providing a fluid seal around the fluid entry reservoir 313 adjacent to the valve membrane 350.

[0063] As the fluid flows into the fluid entry reservoir 313 it increases pressure on the valve membrane 350, which is balanced on the bar 317 in a pressure neutral position, the valve membrane 350 separating the fluid entry reservoir 313 from the fluid exit reservoir 315. When the pressure (e.g., fluid pressure) on the valve membrane 350 exceeds a threshold (e.g.,cracking pressure), the end and the side of the valve membrane 350 that are not supported by the bar 317 flex away from the sealing surface 319 and into the fluid exit reservoir 315, thus allowing the fluid in the fluid entry reservoir 313 to flow into the fluid exit reservoir 315 and out through the outlet tube port 318.

[0064] When the fluid pressure against a valve membrane surface 354 of the valve membrane 350 in the fluid exit reservoir 315 is the same as the fluid pressure in the fluid entry reservoir 313 against the valve membrane surface 352, the flexed end and side of the valve membrane 350 flex back against the sealing surface 319 and into the pressure neutral position, again separating the fluid entry reservoir 313 from the fluid exit reservoir 315. This equalizing pressure may be caused when the fluid flow from the eye 190 through the inlet tube 180 lessens or stops and / or by a preload or bias of the valve membrane 350 towards the sealing surface 319. The valve membrane 350 may thus flex from the pressure neutral position in increasing levels of flex into the fluid exit reservoir 315 as the fluid pressure on the valve membrane surface 352 adjacent the fluid entry reservoir 313 increases.

[0065] Accordingly, the valve membrane 350 may flex back and forth to any position between the sealed pressure neutral position (e.g., no fluid flow past the valve membrane 350) and a fully flexed position (e.g., full fluid flow past the valve membrane 350) based on changes in the opposing fluid pressures against the valve membrane surface 352 and the valve membrane surface 354 and / or biasing properties of the valve membrane 350. The material composition of the valve membrane 350 may be selected or formed to provide a specific amount of stiffness, bias and / or flexibility for the valve membrane 350, thus providing for a desired amount of flex of the valve membrane 350 for a particular pressure exerted on the valve membrane surface 352. Here, a valve membrane 350 having a stiffer / less flexible material form and / or stronger biasing / preloading properties towards the sealing surface 319 would require a higher cracking pressure on the valve member 350 to allow fluid flow from the fluid entry reservoir 313 past the valve membrane 350 and into the fluid exit reservoir 315 than would a valve membrane 350 having a more flexible material form and / or weaker biasing / preloading properties.

[0066] According to aspects of the disclosure, as shown in FIGS. 13 and 14, an intraocular drainage valve 200, 300 may be coupled via the inlet tube port 216, 316 to an inlet tube 180 (e.g., drainage tube) inserted into the eye 190. The intraocular drainage valve 200, 300 may also be coupled via the outlet tube port 218, 318 to any suitable ocular implant 600, such asthose disclosed in U.S. Patent No. D877,911 and U.S. Patent No. D949,342, both of which are incorporated by reference in their entireties herein. For example, as shown in FIG. 13, the outlet tube port 218, 318 may be coupled to an outlet tube 182, which in turn is coupled to a fluid port 610 of the ocular implant 600. As another example, as shown in FIG. 14, the outlet tube port 218, 318 may be coupled directly to the fluid port 610 of the ocular implant 600.

[0067] In aspects of the disclosure, any of the other intraocular drainage valves 100, 400, 500 disclosed herein may be coupled to or used in conjunction with an ocular implant 600. For example, the outlet tube port 418 of intraocular drainage valve 400 may be coupled to the outlet tube 182, which in turn is coupled to a fluid port 610 of the ocular implant 600, or the outlet tube port 418 may be coupled directly to the fluid port 610 of the ocular implant 600. As another example, some or all of the fluid flowing out of exit port(s) 118 of intraocular drainage valve 100 or exit port 418 of intraocular drainage valve 400 may flow across the surface of the eye 190 and into the fluid port 610 of the ocular implant 600.

[0068] According to aspects of the disclosure, as shown in FIGS. 15-18, an intraocular drainage valve 400 includes a housing 410 having a fluid entry portion 412, a fluid exit portion 414 and a tube port 416. The tube port 416 is configured to be coupled to a tube 180, where the tube 180 may be inserted into an eye 190 to drain aqueous humour. The fluid exit portion 414 has two fluid reservoirs 413. The fluid entry portion 412 has a flexible valve membrane 450 that forms a flexible wall that encloses a portion of the fluid exit portion 414, such as enclosing each of the fluid reservoirs 413. The valve membrane 450 is formed of any suitable flexible material, such as silicone and the like. A sealing surface 419 is the outer surface of the fluid exit portion 414 and outlines or defines the two fluid reservoirs 413. The sealing surface 419 provides a seal against the valve membrane 450, thus enclosing the fluid reservoirs 413 within the intraocular drainage valve 400.

[0069] For example, as shown in FIG. 18, the valve membrane 450 rests against the sealing surface 419 when the intraocular drainage valve 400 is assembled. The fluid entry portion 412 has an entry port 411 disposed between the tube port 416 and each fluid reservoir 413, as well as an exit port 418. The fluid exit portion 414 also includes an end cap 415.

[0070] In use, the tube port 416 may be coupled to the tube 180 that has been inserted into the eye 190 to drain a fluid such as aqueous humour, such as by molding the tube 180 and the tube port 416 as one component. In aspects of the disclosure, the tube port 416 may be coupledto the tube 180 by being inserted into an end of the tube 180 and held in place by a friction fit, an adhesive and / or a solvent. As fluid pressure increases in the eye 190, fluid drains out of the eye 190 through the tube 180 and into the tube port 416, which then flows through the entry ports 411 and into the fluid reservoirs 413. Here, the sealing surface 419 of the fluid exit portion 414 is flush against an inner valve membrane surface 452 of the valve membrane 450, thus providing a fluid seal around the fluid reservoirs 413 adjacent to the valve membrane 450.

[0071] As the fluid flows into the fluid reservoirs 413 it increases pressure on the valve membrane 450, which causes the valve membrane 450 to flex (e.g., bulge) outward away from the fluid exit portion 414. When the pressure (e.g., fluid pressure) on the valve membrane 450 exceeds a threshold (e.g., cracking pressure), the valve membrane 450 flexes away from the sealing surface 419, thus allowing the fluid in the fluid reservoirs 413 to flow over the sealing surface 419 and out through the exit port 418.

[0072] When the fluid pressure against an outer valve membrane surface 454 of the valve membrane 450 is the same as the fluid pressure in the fluid reservoirs 413 against the valve membrane surface 452 (e.g., the fluid flow from the eye 190 through the tube 180 lessens or stops, a biasing property of the material of the valve membrane 450), the valve membrane 450 flexes back against the sealing surface 419 and into the pressure neutral position, again sealing the fluid reservoirs 413 from the exit port 418. The valve membrane 450 may thus flex from the pressure neutral position in increasing levels of flex outward from the fluid reservoirs 413 as the fluid pressure on the valve membrane surface 452 adjacent the fluid reservoirs 413 increases.

[0073] Accordingly, the valve membrane 450 may flex inward and outward to any position between the sealed pressure neutral position (e.g., no fluid flow past the valve membrane 450) and a fully flexed position (e.g., full fluid flow past the valve membrane 450) based on changes in the opposing fluid pressures against the valve membrane surface 452 and the valve membrane surface 354 and / or a biasing force of the valve membrane 450 towards the sealing surface 419. The material composition of the valve membrane 450 may be selected or formed to provide a specific amount of stiffness, bias and / or flexibility for the valve membrane 450, thus providing for a desired amount of flex of the valve membrane 450 for a particular pressure exerted on the valve membrane surface 452. Here, a valve membrane 450 having a stiffer / less flexible material form and / or stronger biasing / preloading properties towards the sealing surface 419 would require a higher cracking pressure on the valve member 450 to allow fluid flowfrom the fluid reservoirs 413 past the valve membrane 450 and out the exit port 418 than would a valve membrane 450 having a more flexible material form and / or weaker biasing properties.

[0074] According to aspects of the disclosure, the width, height and depth of each fluid reservoir 413 may be configured as desired to allow for a particular volume of fluid to be contained within the fluid reservoir 413. According to aspects of the disclosure, the diameter, length and / or any other dimension of each entry port 411 may be configured as desired to allow for a particular volume of fluid to flow into the corresponding fluid reservoir 413.

[0075] According to aspects of the disclosure, as shown in FIGS. 19-21, an intraocular drainage valve 500 includes a housing 510 having a fluid entry portion 512, a fluid exit portion 514, an inlet tube port 516 and an outlet tube port 518. The inlet tube port 516 is configured to be coupled to a tube 180, where the tube 180 may be inserted into an eye 190 to drain aqueous humour. The fluid exit portion 514 has two fluid reservoirs 513. The fluid entry portion 512 has a flexible valve membrane 550 that forms a flexible wall that encloses a portion of the fluid exit portion 514, such as enclosing each of the fluid reservoirs 513. The valve membrane 550 is formed of any suitable flexible material, such as silicone and the like. A sealing surface 519 is the outer surface of the fluid exit portion 514 and outlines or defines the two fluid reservoirs 513. The sealing surface 519 provides a seal against the valve membrane 550, thus enclosing the fluid reservoirs 513 within the intraocular drainage valve 500.

[0076] For example, as shown in FIG. 21, the valve membrane 550 rests against the sealing surface 519 when the intraocular drainage valve 500 is assembled. The fluid entry portion 512 has an entry port 511 disposed between the inlet tube port 516 and each fluid reservoir 513, as well as an exit port 517. The fluid exit portion 514 also includes an outlet port 515 in the sealing surface 519 and fluidly coupled to the outlet tube port 518, the outlet port 515 configured to channel the fluid flowing out of the fluid reservoirs 513 and over the sealing surface 519 adjacent to the fluid reservoirs 513 into the outlet tube port 518. In aspects of the disclosure, there may be one outlet port 515 only, an outlet port 515 on each side of the fluid exit portion 514 corresponding to each fluid reservoir 513, or any suitable number of outlet ports 515, for example.

[0077] In use, the inlet tube port 516 may be coupled to the tube 180 that has been inserted into the eye 190 to drain a fluid such as aqueous humour, such as by the inlet tube port 516 being inserted into an end of the tube 180 and held in place by a friction fit, an adhesive and / ora solvent. As fluid pressure increases in the eye 190, fluid drains out of the eye 190 through the tube 180 and into the inlet tube port 516, which then flows through the entry ports 511 and into the fluid reservoirs 513. Here, the sealing surface 519 of the fluid exit portion 514 is flush against an inner valve membrane surface 552 of the valve membrane 550, thus providing a fluid seal around the fluid reservoirs 513 adjacent to the valve membrane 550.

[0078] As the fluid flows into the fluid reservoirs 513 it increases pressure on the valve membrane 550, which causes the valve membrane 550 to flex (e.g., bulge) outward away from the fluid exit portion 514. When the pressure (e.g., fluid pressure) on the valve membrane 550 exceeds a threshold (e.g., cracking pressure), the valve membrane 550 flexes away from the sealing surface 519, thus allowing the fluid in the fluid reservoirs 513 to flow over the sealing surface 519 to the outlet port(s) 515 and out through the outlet tube port 518. In aspects of the disclosure, the fluid flowing out of the fluid reservoirs 513 may only flow out through the outlet port(s) 515 while the seal between the end portion of the sealing surface 519 and the inner valve membrane surface 552 of the valve membrane 550 at the exit port 517 remains tight against the fluid flow. In aspects of the disclosure, the fluid flowing out of the fluid reservoirs 513 may flow out through the outlet port(s) 515 and out through the exit port 517, such as by being forced out between the sealing surface 519 and the inner valve membrane surface 552 of the valve membrane 550 based on the fluid pressure overcoming the seal between the end portion of the sealing surface 519 and the inner valve membrane surface 552 of the valve membrane 550 at the exit port 517.

[0079] When the fluid pressure against an outer valve membrane surface 554 of the valve membrane 550 is the same as the fluid pressure in the fluid reservoirs 513 against the valve membrane surface 552 (e.g., the fluid flow from the eye 190 through the tube 180 lessens or stops, a biasing property of the material of the valve membrane 550), the valve membrane 550 flexes back against the sealing surface 519 adjacent the fluid reservoirs 513 and into the pressure neutral position, again sealing the fluid reservoirs 513 from the outlet tube port 518. The valve membrane 550 may thus flex from the pressure neutral position in increasing levels of flex outward from the fluid reservoirs 513 as the fluid pressure on the valve membrane surface 552 adjacent the fluid reservoirs 513 increases.

[0080] Accordingly, the valve membrane 550 may flex inward and outward to any position between the sealed pressure neutral position (e.g., no fluid flow past the valve membrane 550) and a fully flexed position (e.g., full fluid flow past the valve membrane 550) based on changesin the opposing fluid pressures against the valve membrane surface 552 and the valve membrane surface 554 and / or a biasing force of the valve membrane 550 towards the sealing surface 519. The material composition of the valve membrane 550 may be selected or formed to provide a specific amount of stiffness, bias and / or flexibility for the valve membrane 550, thus providing for a desired amount of flex of the valve membrane 550 for a particular pressure exerted on the valve membrane surface 552. Here, a valve membrane 550 having a stiffer / less flexible material form and / or stronger biasing properties towards the sealing surface 519 would require a higher cracking pressure on the valve member 550 to allow fluid flow from the fluid reservoirs 513 past the valve membrane 550 and out the outlet tube port 518 via the outlet port(s) 515 and / or the exit port 517 than would a valve membrane 550 having a more flexible material form and / or weaker biasing properties.

[0081] According to aspects of the disclosure, the width, height and depth of each fluid reservoir 513 may be configured as desired to allow for a particular volume of fluid to be contained within the fluid reservoir 513. According to aspects of the disclosure, the diameter, length and / or any other dimension of each entry port 511 may be configured as desired to allow for a particular volume of fluid to flow into the corresponding fluid reservoir 513.

[0082] In aspects of the disclosure, the components and structures of the intraocular drainage valve 400 may be the same as the components and structures of the intraocular drainage valve 500, with the exception of the addition of the outlet port(s) 515 coupled to the outlet tube port 518 for the intraocular drainage valve 500.

[0083] In aspects of the disclosure, any of the components and structures of any of the intraocular drainage valves 100, 200, 300, 400, 500 may be used in any of the other intraocular drainage valves 100, 200, 300, 400, 500.

[0084] In aspects of the disclosure, as shown in FIGS. 22A to 22C, an intraocular drainage valve 700 (e.g., intraocular drainage valve 100, 200, 300) may be assembled by disposing a flat piece of material (e.g., silicone) 750 (e.g., valve membrane 150, 250, 350) between a fluid entry portion 712 (e.g., fluid entry portion 112, 212, 312) and a fluid exit portion 714 (e.g., fluid exit portion 114, 214, 314) and pushing it into a bowl or cylindrical concave sealing surface 719 (e.g., sealing surface 119, 219, 319) within the fluid entry portion 712. Since the silicone 750 is biased to return to a flat shape as shown by the dashed outline in FIG. 22C, the silicone 750 pushes on the sealing surface 719 and creates a seal to close off the fluid entry reservoir 713(e.g., fluid entry reservoir 113, 213, 313). The pressure at which the intraocular drainage valve 700 opens (e.g., cracking pressure) can be dialed in by adjusting the amount of deflection that is imparted on the silicone 750 during assembly.

[0085] In aspects of the disclosure, the fluid entry portions and the fluid exit portions may be coupled together in any suitable way (e.g., welded, adhesive). The coupling may provide a fluid tight seal between the mating surfaces of the fluid entry portions and the fluid exit portions.

[0086] According to aspects of the disclosure, as shown in FIGS. 23 A to 231, an intraocular drainage valve 800 includes a housing 810 having a sealing portion 814 and an opposing fluid entry / exit portion 812 that includes an inlet tube port 816 and an outlet tube port 818. The inlet tube port 816 is configured to be coupled to an inlet tube 180, where the inlet tube 180 may be inserted into an eye 190 to drain aqueous humour. The fluid entry / exit portion 812 includes a fluid entry reservoir 813 fluidly coupled to the inlet tube port 816 and a fluid exit reservoir 815 fluidly coupled to the outlet tube port 818. The fluid entry reservoir 813 and the fluid exit reservoir 815 are separated by a valve membrane 850 that is disposed on and / or coupled to a membrane base 817 of the fluid entry / exit portion 812. While the membrane base 817 shown in FIG. 23B is a squared U-shape, the membrane base 817 may be any suitable shape. The membrane base 817 may define a valve portion 813a of the fluid entry reservoir 813 and include a sealing surface 819 (e.g., top surface) to provide a seal against the valve membrane 850. The sealing surface 819 may include a fluid exit channel disposed adjacent the outlet tube port 818 similar to fluid exit channel 323 of intraocular drainage valve 300.

[0087] The valve membrane 850 is formed of any suitable flexible material, such as silicone and the like. The valve membrane 850 may include an entry reservoir anchor 852 configured to be received in the fluid entry reservoir 813. For example, the entry reservoir anchor 852 shown in FIGS. 23 A, 23B has two extensions 854 that are disposed in the fluid entry reservoir 813 between side surfaces 817a of the membrane base 817 and the inlet tube port 816. A fluid channel 856 is disposed between the two extensions 854 to allow fluid to flow from the inlet tube port 816 through the fluid entry reservoir 813 and into the valve portion 813a. The valve membrane 850 may also include a sealing portion anchor 858 configured to be received in a cavity 824 of the sealing portion 814. The sealing portion anchor 858 and the entry reservoir anchor 852 provide for securing the valve membrane 850 into position within the housing 810.

[0088] The sealing portion 814 includes a bar 822 configured to engage a surface 851 (e.g., top surface) of the valve membrane 850. For example, as shown in FIGS. 23 A, 23B, the bar 822 has a first leg 822a that extends across a portion of an end (e.g., width) of the valve membrane 850 adjacent to the sealing portion anchor 858 and a second leg 822b that extends along a portion of the side (e.g., lengthwise) of the valve membrane 850, the two legs 822a, 822b forming an L-shape. The bar 822 engages the surface 851 of the valve membrane 850 such that the valve membrane 850 is pressed against a portion (e.g., one end and one side) of the sealing surface 819 by the bar 822.

[0089] The sealing portion 814 also includes an exit reservoir anchor 826 configured to be received in the fluid exit reservoir 815. For example, the exit reservoir anchor 826 shown in FIGS. 23 A, 23B has two extensions 828 that are disposed in the fluid exit reservoir 815 between a side surface 817b of the membrane base 817 and the outlet tube port 818. A fluid channel 827 is disposed between the two extensions 828 to allow fluid to flow from the valve portion 813a through the fluid exit reservoir 815 and into the outlet tube port 818 when a portion of the valve membrane 850 is not sealed against the sealing surface 819 (e.g., pushed away from the sealing surface 819 by fluid pressure).

[0090] The sealing portion 814 may also include a coupling protrusion 825 disposed adjacent an outer perimeter of the sealing portion 814. For example, the coupling protrusion 825 may be an ultrasonic welding feature (e.g., energy director). The coupling protrusion 825 may be received by a corresponding coupling channel 823 disposed adjacent an outer perimeter of the fluid entry / exit portion 812 (see FIG. 23C). For example, when the coupling protrusion 825 and the coupling channel 823 are engaged or mated, the sealing portion 814 and the fluid entry / exit portion 812 may be secured (e.g., ultrasonically welded) together to form a sealed housing 810 with the inlet tube port 816 and the outlet tube port 818 being the only entry and exit points for fluid. In aspects of the disclosure, the coupling channel 823 may be formed when the coupling protrusion 825 is engaged against a surface 811 (e.g., top surface) of the fluid entry / exit portion 812 and a resulting ultrasonic welding causes the coupling protrusion 825 to sink into the surface 811 to create the coupling channel 823, thus sealing the sealing portion 814 and the fluid entry / exit portion 812 together.

[0091] The sealing portion 814 also includes a flex cavity 829 configured to provide room for the valve membrane 850 to flex away (e.g., upward) from the sealing surface 819 of the base membrane 817 (see FIGS. 23G, 231).

[0092] In use, as shown in FIG. 23H, the bar 822 of the sealing portion 814 compresses into the top surface 851 of the valve membrane 850 and presses the portion of the valve membrane 850 engaged by the bar 822 into the sealing surface 819 of the membrane base 817, thus functioning as a hinge, for example. As fluid flows from the tube 180 into the valve portion 813a of the fluid entry reservoir 813 it causes a fluid pressure force P to be exerted against a flap portion 853 of the valve membrane 850. When the fluid pressure force P reaches a force threshold, the fluid pressure force P causes the flap portion 853 to move into the flex cavity 829 of the sealing portion 814 (see FIG. 231), thus providing a fluid pathway for fluid to flow from the valve portion 813a past (e.g., over) a portion of the sealing surface 819 into the fluid exit reservoir 815 and out the outlet tube port 818. When the fluid pressure force P falls back below the force threshold, the flap portion 853 moves back towards the valve portion 813a and the valve membrane 850 seals against the sealing surface 819 of the membrane base 817 to close off the fluid pathway between the valve portion 813a and the fluid exit reservoir 815. This cycle may repeat as the fluid pressure force P again reaches the force threshold and then falls below the force threshold. Further, as long as the fluid pressure force P equals or exceeds the force threshold, the fluid pathway will exist between the valve portion 813a and the fluid exit reservoir 815.

[0093] In aspects of the disclosure, the sealing portion 814 and the fluid entry / exit portion 812 may be coupled together in any suitable way (e.g., welded, adhesive). The coupling may provide a fluid tight seal between mated surfaces of the sealing portion 814 and the fluid entry / exit portion 812.

[0094] According to aspects of the disclosure, as shown in FIGS. 24A to 24D, an intraocular drainage valve 800 may be coupled via the inlet tube port 816 to a tube (e.g., drainage tube 180) to be inserted into an eye (e.g., eye 190). The intraocular drainage valve 800 may also be coupled via the outlet tube port 818 to any suitable ocular implant 900, such as those disclosed in U.S. Patent No. D877,911 and U.S. Patent No. D949,342, both of which are incorporated by reference in their entireties herein. For example, as shown in FIGS. 24 A to 24C, the outlet tube port 818 may be coupled directly to a fluid port 910 of the ocular implant 900. As shown in FIG. 24B, the fluid port 910 may branch off into multiple outlet ports 920. In use, fluid flows from the eye 190 into the drainage tube 180, through the intraocular drainage valve 800, out through the outlet tube port 818, through the fluid port 910 and the outlet ports 920 into areas exterior to the eye 190.

[0095] In aspects of the disclosure, the outlet tube port 818 may be coupled to a tube (e.g., outlet tube 182), which in turn may be coupled to the fluid port 910 of the ocular implant 900 similar to that as shown in FIG. 13. In aspects of the disclosure, the outlet tube port 818 may be coupled to a tube (e.g., outlet tube 182), which in turn may be disposed externally to the eye 190 such that the fluid flows from the intraocular drainage valve 800 directly into tissue or fluid external to the eye 190.

[0096] According to aspects of the disclosure, as shown in FIG. 24D, the intraocular drainage valve 800 may be fully or partially inserted into a pocket 930 of the ocular implant 900, thus enclosing at least a portion of the intraocular drainage valve 800 within the ocular implant 900. The pocket 930 may include a top sealing layer 932 and a bottom sealing layer 934, each of which may be mated to the ocular implant 900 or integrally formed with the ocular implant 900.

[0097] In aspects of the disclosure, any of the other intraocular drainage valves 100, 200, 300, 400, 500 disclosed herein may be coupled to or used in conjunction with the ocular implant 900 similarly as discussed above regarding ocular implant 600.

[0098] According to aspects of the disclosure, as shown in FIG. 25, an intraocular drainage valve 1000 may include barbs 1001 disposed on either or both inlet tube port 1016 and an outlet tube port 1018. Here the barbs 1001 may increase retention strength between inlet tube port 1016 / outlet tube port 1018 and the corresponding drainage tubes 180. The outlet tube port 1018 may have one or more exit ports 1118 to allow drainage of fluid from the outlet tube port 1018. In aspects of the disclosure, any of the intraocular drainage valves 100, 200, 300, 400, 500, 800 disclosed herein may include similar barbs (e.g., barbs 1001) and / or exit ports (e.g., exit ports 1118).

[0099] In one or more embodiments, an intraocular drainage valve includes a housing, comprising a fluid entry / exit portion having an inlet tube port, a fluid entry reservoir, an outlet tube port, a fluid exit reservoir and a membrane base having a sealing surface and defining a valve portion of the fluid entry reservoir and a sealing portion having a bar extending towards the membrane base; and a valve membrane disposed between the valve portion of the fluid entry reservoir and the bar with a first portion of the valve membrane pressed against the bar, wherein a flap portion of the valve membrane is configured to seal against the sealing surface of the membrane base to seal the valve portion of the fluid entry reservoir at a first fluidpressure, and wherein the flap portion of the valve membrane is configured to flex away from a portion of the sealing surface of the membrane base at a second fluid pressure.

[0100] In aspects of the disclosure, the inlet tube port is coupled to a drainage tube configured to be inserted into an eye. In aspects of the disclosure, the housing has a concave curvature. In aspects of the disclosure, the sealing portion comprises a flex cavity configured to receive the flap portion of the valve membrane when it flexes away from the sealing surface of the membrane base. In aspects of the disclosure, the fluid exit reservoir is fluidly coupled to the exit port, and wherein the intraocular drainage valve is configured to selectively provide fluid flow from the fluid entry reservoir into the fluid exit reservoir and out through the exit port to be deposited external to the housing.

[0101] In aspects of the disclosure, the bar comprises a first leg disposed across a portion of a width of a first end of the fluid entry reservoir adjacent to the inlet tube port and a second leg disposed along a portion of a length of a first side of the membrane base. In aspects of the disclosure, the valve membrane has a first end compressed by the first leg of the bar and a first side compressed by the second leg of the bar, and wherein the flap portion of the valve membrane is defined by an intersection of a second end of the valve membrane and a second side of the valve membrane. In aspects of the disclosure, the exit port of the fluid exit portion comprises an outlet tube port fluidly coupled to the fluid exit reservoir, wherein the intraocular drainage valve is configured to selectively provide fluid flow from the fluid entry reservoir into the fluid exit reservoir and out through the outlet tube port.

[0102] In aspects of the disclosure, the outlet tube port is coupled to an outlet tube configured to be coupled to an ocular implant device separate from the intraocular drainage valve. In aspects of the disclosure, the outlet tube port is coupled directly to a fluid port of an ocular implant device separate from the intraocular drainage valve. In aspects of the disclosure, the sealing surface comprises a fluid exit channel disposed adjacent to the outlet tube port. In aspects of the disclosure, the valve membrane comprises a sealing portion anchor disposed adjacent to the inlet tube port and an entry reservoir anchor disposed on an opposing surface of the valve membrane and adjacent to the inlet tube port.

[0103] In aspects of the disclosure, the sealing portion anchor is received by a cavity in the sealing portion and the entry reservoir anchor is received in the fluid entry reservoir to provideaccurate alignment of the valve membrane between the sealing portion and the fluid entry / exit portion. In aspects of the disclosure, the sealing portion anchor comprises two extensions and a fluid channel disposed between the two extensions, the fluid channel configured to allow fluid flow from the inlet tube port through the fluid entry reservoir and into the valve portion. In aspects of the disclosure, the sealing portion comprises a coupling protrusion disposed adjacent an outer perimeter of the sealing portion that is sealing received by a coupling channel disposed adjacent an outer perimeter of the fluid entry / exit portion.

[0104] In aspects of the disclosure, the sealing portion comprises an exit reservoir anchor disposed in the fluid exit reservoir adjacent to the outlet tube port. In aspects of the disclosure, the exit reservoir anchor comprises two extensions and a fluid channel disposed between the two extensions, the fluid channel configured to allow fluid flow from the valve portion through the fluid exit reservoir and into the outlet tube port.

[0105] In one or more embodiments, a method of operating an intraocular drainage valve comprises receiving, by an inlet tube port of a fluid entry / exit portion of a housing of the intraocular drainage valve, ocular fluid from an eye flowing through a drainage tube coupled to the inlet tube port; receiving, from the inlet tube port, the ocular fluid into a valve portion of a fluid entry reservoir of the fluid / exit entry portion; engaging a first portion of a valve membrane against a bar of a sealing portion of the housing of the intraocular drainage valve; engaging a flap portion of the valve membrane against a sealing surface of a membrane base of the fluid entry / exit portion, the membrane base defining the valve portion of the fluid entry reservoir; preventing, by the flap portion of the valve membrane, the ocular fluid from flowing from the valve portion of the fluid entry reservoir to a fluid exit reservoir of the fluid entry / exit portion at a first fluid pressure of the ocular fluid in the valve portion; flexing, away from the sealing surface, the flap portion at a second fluid pressure of the ocular fluid in the valve portion of the fluid entry reservoir that is greater than the first fluid pressure; receiving, by an outlet tube port, ocular fluid flowing from the valve portion of the fluid entry reservoir through a fluid pathway between the membrane base and the flexed flap portion of the valve membrane; and discharging, from the outlet tube port, the ocular fluid external to the intraocular drainage valve.

[0106] In aspects of the disclosure, the method further comprises discharging the ocular fluid from the outlet tube port into bodily matter disposed around the intraocular drainage valve; discharging the ocular fluid from the outlet tube port into an outlet tube having a firstend of the outlet tube fluidly coupled to the outlet tube port and a second end of the outlet tube fluidly coupled to a fluid port of an ocular implant; and discharging the ocular fluid from the outlet tube port directly into a fluid port of the ocular implant.

[0107] In one or more embodiments, an intraocular drainage assembly includes an ocular implant configured to be implanted adjacent an eye and an intraocular drainage valve, comprising: a housing comprising a fluid entry / exit portion and a sealing portion, the fluid entry / exit portion comprising an inlet tube port, a fluid entry reservoir, an outlet tube port, a fluid exit reservoir and a membrane base having a sealing surface and defining a valve portion of the fluid entry reservoir, and the sealing portion comprising a bar extending towards the membrane base; and a valve membrane disposed between the valve portion of the fluid entry reservoir and the bar with a first portion of the valve membrane pressed against the bar, wherein a flap portion of the valve membrane is configured to seal against the sealing surface of the membrane base to seal the valve portion of the fluid entry reservoir at a first fluid pressure, and wherein the flap portion of the valve membrane is configured to flex away from a portion of the sealing surface of the membrane base at a second fluid pressure to form a fluid pathway between the membrane base and the flexed flap portion of the valve membrane.

[0108] According to aspects of the disclosure, any of the above described intraocular drainage valves may be surgically implanted in the eye by either an ab extemo process or an ab interno process. An ab externo process may include dissecting the outside conjuctiva of the eye, inserting (e.g., poking in) a first end of the drainage tube into the anterior chamber, suturing the drainage tube and / or intraocular drainage valve in place (e.g., sutured to the sclera) and reapproximating and suturing the conjunctiva closed. Here, the intraocular drainage valve is already coupled to a second end of the drainage tube and the and the first end of the drainage tube is the only element that enters the interior of the eye (e.g., the anterior chamber) while the second end of the drainage tube and the intraocular drainage valve are disposed in the subconjunctival or sub-tenon space of the eye.

[0109] On the other hand, an ab interno process may include placing the intraocular drainage valve and drainage tube into a medical instrument (e.g., an inserter), inserting the inserter into the eye and poking the drainage tube through into the interior of the eye (e.g., the anterior chamber) or depositing the drainage tube within the interior of the eye. The outflow end of the drainage tube and intraocular drainage valve may be placed near the side of the eyenext to the nose of the patient. A surgical procedure for inserting an intraocular drainage device having a plate (e.g., ocular implant 600) may include dissecting the external surface of the eye, inserting the plate into the external surface, couple the intraocular drainage valve between the plate and the drainage tube, and insert the drainage tube into the interior of the eye. With the intraocular drainage valve in place, additional typical surgical steps when using just the drainage tube and plate are no longer required. In particular, there is no need to tie off the drainage tube, wait 2-3 weeks for the external surface of the eye to heal around the plate to trap the plate in the external eye material, and untying the drainage tube so that back pressure starts a fluid flow. Thus, a strong benefit of using the intraocular drainage valve is to remove the need to wait 2-3 weeks before the patient can get pressure relief.

[0110] It is understood that any specific order or hierarchy of blocks in the methods of processes disclosed is an illustration of example approaches. Based upon design or implementation preferences, it is understood that the specific order or hierarchy of blocks in the processes may be rearranged, or that all illustrated blocks be performed. In some implementations, any of the blocks may be performed simultaneously.[OHl] The present disclosure is provided to enable any person skilled in the art to practice the various aspects described herein. The disclosure provides various examples of the subject technology, and the subject technology is not limited to these examples. Various modifications to these aspects will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other aspects.

[0112] A reference to an element in the singular is not intended to mean “one and only one” unless specifically so stated, but rather “one or more.” Unless specifically stated otherwise, the term “some” refers to one or more. Pronouns in the masculine (e.g., his) include the feminine and neuter gender (e.g., her and its) and vice versa. Headings and subheadings, if any, are used for convenience only and do not limit the invention.

[0113] The word “exemplary” is used herein to mean “serving as an example or illustration.” Any aspect or design described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other aspects or designs. In one aspect, various alternative configurations and operations described herein may be considered to be at least equivalent.

[0114] As used herein, the phrase “at least one of’ preceding a series of items, with the term “or” to separate any of the items, modifies the list as a whole, rather than each item of the list. The phrase “at least one of’ does not require selection of at least one item; rather, the phrase allows a meaning that includes at least one of any one of the items, and / or at least one of any combination of the items, and / or at least one of each of the items. By way of example, the phrase “at least one of A, B, or C” may refer to: only A, only B, or only C; or any combination of A, B, and C.

[0115] A phrase such as an “aspect” does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. A disclosure relating to an aspect may apply to all configurations, or one or more configurations. An aspect may provide one or more examples. A phrase such as an aspect may refer to one or more aspects and vice versa. A phrase such as an “embodiment” does not imply that such embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. A disclosure relating to an embodiment may apply to all embodiments, or one or more embodiments. An embodiment may provide one or more examples. A phrase such an embodiment may refer to one or more embodiments and vice versa. A phrase such as a “configuration” does not imply that such configuration is essential to the subject technology or that such configuration applies to all configurations of the subject technology. A disclosure relating to a configuration may apply to all configurations, or one or more configurations. A configuration may provide one or more examples. A phrase such a configuration may refer to one or more configurations and vice versa.

[0116] In one aspect, unless otherwise stated, all measurements, values, ratings, positions, magnitudes, sizes, and other specifications that are set forth in this specification, including in the claims that follow, are approximate, not exact. In one aspect, they are intended to have a reasonable range that is consistent with the functions to which they relate and with what is customary in the art to which they pertain.

[0117] It is understood that the specific order or hierarchy of steps, operations or processes disclosed is an illustration of exemplary approaches. Based upon design preferences, it is understood that the specific order or hierarchy of steps, operations or processes may be rearranged. Some of the steps, operations or processes may be performed simultaneously. Some or all of the steps, operations, or processes may be performed automatically, without theintervention of a user. The accompanying method claims, if any, present elements of the various steps, operations or processes in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

[0118] All structural and functional equivalents to the elements of the various aspects described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and are intended to be encompassed by the claims. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the claims. No claim element is to be construed under the provisions of 35 U.S.C. §112 (f) unless the element is expressly recited using the phrase “means for” or, in the case of a method claim, the element is recited using the phrase “step for.” Furthermore, to the extent that the term “include,” “have,” or the like is used, such term is intended to be inclusive in a manner similar to the term “comprise” as “comprise” is interpreted when employed as a transitional word in a claim.

[0119] The Title, Background, Summary, Brief Description of the Drawings and Abstract of the disclosure are hereby incorporated into the disclosure and are provided as illustrative examples of the disclosure, not as restrictive descriptions. It is submitted with the understanding that they will not be used to limit the scope or meaning of the claims. In addition, in the Detailed Description, it can be seen that the description provides illustrative examples and the various features are grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed subject matter requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed configuration or operation. The following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separately claimed subject matter.

[0120] The claims are not intended to be limited to the aspects described herein, but are to be accorded the full scope consistent with the language claims and to encompass all legal equivalents. Notwithstanding, none of the claims are intended to embrace subject matter that fails to satisfy the requirement of 35 U.S.C. § 101, 102, or 103, nor should they be interpreted in such a way.

Claims

CLAIMSWhat is claimed is:

1. An intraocular drainage valve, comprising: a housing, comprising; a fluid entry / exit portion having an inlet tube port, a fluid entry reservoir, an outlet tube port, a fluid exit reservoir and a membrane base having a sealing surface and defining a valve portion of the fluid entry reservoir; and a sealing portion having a bar extending towards the membrane base; and a valve membrane disposed between the valve portion of the fluid entry reservoir and the bar with a first portion of the valve membrane pressed against the bar, wherein a flap portion of the valve membrane is configured to seal against the sealing surface of the membrane base to seal the valve portion of the fluid entry reservoir at a first fluid pressure, and wherein the flap portion of the valve membrane is configured to flex away from a portion of the sealing surface of the membrane base at a second fluid pressure.

2. The intraocular drainage valve of claim 1, wherein the inlet tube port is coupled to a drainage tube configured to be inserted into an eye.

3. The intraocular drainage valve of claim 1 , wherein the housing has a concave curvature.

4. The intraocular drainage valve of claim 1, wherein the sealing portion comprises a flex cavity configured to receive the flap portion of the valve membrane when it flexes away from the sealing surface of the membrane base.

5. The intraocular drainage valve of claim 1, wherein the fluid exit reservoir is fluidly coupled to the exit port, and wherein the intraocular drainage valve is configured to selectively provide fluid flow from the fluid entry reservoir into the fluid exit reservoir and out through the exit port to be deposited external to the housing.

6. The intraocular drainage valve of claim 1, wherein the bar comprises a first leg disposed across a portion of a width of a first end of the fluid entry reservoir adjacent to the inlet tube port and a second leg disposed along a portion of a length of a first side of the membrane base.

7. The intraocular drainage valve of claim 6, wherein the valve membrane has a first end compressed by the first leg of the bar and a first side compressed by the second leg of the bar, and wherein the flap portion of the valve membrane is defined by an intersection of a second end of the valve membrane and a second side of the valve membrane.

8. The intraocular drainage valve of claim 1, wherein the exit port of the fluid exit portion comprises an outlet tube port fluidly coupled to the fluid exit reservoir, wherein the intraocular drainage valve is configured to selectively provide fluid flow from the fluid entry reservoir into the fluid exit reservoir and out through the outlet tube port.

9. The intraocular drainage valve of claim 8, wherein the outlet tube port is coupled to an outlet tube configured to be coupled to an ocular implant device separate from the intraocular drainage valve.

10. The intraocular drainage valve of claim 8, wherein the outlet tube port is coupled directly to a fluid port of an ocular implant device separate from the intraocular drainage valve.

11. The intraocular drainage valve of claim 8, wherein the sealing surface comprises a fluid exit channel disposed adjacent to the outlet tube port.

12. The intraocular drainage valve of claim 1, wherein the valve membrane comprises a sealing portion anchor disposed adjacent to the inlet tube port and an entry reservoir anchor disposed on an opposing surface of the valve membrane and adjacent to the inlet tube port.

13. The intraocular drainage valve of claim 12, wherein the sealing portion anchor is received by a cavity in the sealing portion and the entry reservoir anchor is received in the fluid entry reservoir to provide accurate alignment of the valve membrane between the sealing portion and the fluid entry / exit portion.

14. The intraocular drainage valve of claim 12, wherein the sealing portion anchor comprises two extensions and a fluid channel disposed between the two extensions, the fluid channel configured to allow fluid flow from the inlet tube port through the fluid entry reservoir and into the valve portion.

15. The intraocular drainage valve of claim 1, wherein the sealing portion comprises a coupling protrusion disposed adjacent an outer perimeter of the sealing portion that is sealing received by a coupling channel disposed adjacent an outer perimeter of the fluid entry / exit portion.

16. The intraocular drainage valve of claim 1 , wherein the sealing portion comprises an exit reservoir anchor disposed in the fluid exit reservoir adjacent to the outlet tube port.

17. The intraocular drainage valve of claim 16, wherein the exit reservoir anchor comprises two extensions and a fluid channel disposed between the two extensions, the fluid channel configured to allow fluid flow from the valve portion through the fluid exit reservoir and into the outlet tube port.

18. A method of operating an intraocular drainage valve, the method comprising: receiving, by an inlet tube port of a fluid entry / exit portion of a housing of the intraocular drainage valve, ocular fluid from an eye flowing through a drainage tube coupled to the inlet tube port; receiving, from the inlet tube port, the ocular fluid into a valve portion of a fluid entry reservoir of the fluid / exit entry portion; engaging a first portion of a valve membrane against a bar of a sealing portion of the housing of the intraocular drainage valve; engaging a flap portion of the valve membrane against a sealing surface of a membrane base of the fluid entry / exit portion, the membrane base defining the valve portion of the fluid entry reservoir; preventing, by the flap portion of the valve membrane, the ocular fluid from flowing from the valve portion of the fluid entry reservoir to a fluid exit reservoir of the fluid entry / exit portion at a first fluid pressure of the ocular fluid in the valve portion;flexing, away from the sealing surface, the flap portion at a second fluid pressure of the ocular fluid in the valve portion of the fluid entry reservoir that is greater than the first fluid pressure; receiving, by an outlet tube port, ocular fluid flowing from the valve portion of the fluid entry reservoir through a fluid pathway between the membrane base and the flexed flap portion of the valve membrane; and discharging, from the outlet tube port, the ocular fluid external to the intraocular drainage valve.

19. The method of claim 18, further comprising one of: discharging the ocular fluid from the outlet tube port into bodily matter disposed around the intraocular drainage valve; discharging the ocular fluid from the outlet tube port into an outlet tube having a first end of the outlet tube fluidly coupled to the outlet tube port and a second end of the outlet tube fluidly coupled to a fluid port of an ocular implant; and discharging the ocular fluid from the outlet tube port directly into a fluid port of the ocular implant.

20. An intraocular drainage assembly, comprising: an ocular implant configured to be implanted adjacent an eye; and an intraocular drainage valve, comprising: a housing comprising a fluid entry / exit portion and a sealing portion, the fluid entry / exit portion comprising an inlet tube port, a fluid entry reservoir, an outlet tube port, a fluid exit reservoir and a membrane base having a sealing surface and defining a valve portion of the fluid entry reservoir, and the sealing portion comprising a bar extending towards the membrane base; and a valve membrane disposed between the valve portion of the fluid entry reservoir and the bar with a first portion of the valve membrane pressed against the bar, wherein a flap portion of the valve membrane is configured to seal against the sealing surface of the membrane base to seal the valve portion of the fluid entry reservoir at a first fluid pressure, and wherein the flap portion of the valve membrane is configured to flex away from a portion of the sealing surface of the membrane base at a second fluid pressureto form a fluid pathway between the membrane base and the flexed flap portion of the valve membrane.

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