Body fluid drainage device and method

Abstract

A drainage device for draining bodily fluid from the eye to tissue external to the eye is at least partially implantable within the tissue of the eye. The drainage device includes a body portion including a membrane having a first surface with a first porosity and a second surface with a second porosity greater than the first porosity, and a plate having a porosity less than the first porosity. The membrane is more flexible than the plate and has a first thickness between 25 μm and 125 μm. The plate has a second thickness between 0.8 mm and 2.0 mm. The membrane and the plate define a reservoir. A conduit fluidly coupled to the reservoir and insertable into the eye facilitates drainage of fluid into the conduit. The second surface of the membrane includes one or more ingrowth surface areas for promoting ingrowth of tissue external to the eye.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 63 / 444,089, filed February 8, 2023, the disclosure of which is incorporated herein by reference in its entirety for all purposes.

[0002] Field The present disclosure relates generally to devices and methods for draining and diverting bodily fluids, and more particularly to devices and methods for draining aqueous humor from the anterior chamber (AC) of a patient's eye so that it can be reabsorbed by the body. [Background technology]

[0003] background Various medical interventions involve draining excess fluid from one part of the body and redirecting it to another part of the body for reabsorption. In certain instances, this drainage is achieved through minimally invasive procedures such as endoscopic third ventriculostomy (ETV) and choroid plexus ablation (CPC). In other instances, this drainage is achieved postoperatively through implantable medical devices such as shunts. Various forms of shunts have proven useful in a variety of medical procedures and have been used to treat many diseases, including hydrocephalus and glaucoma.

[0004] Without treatment, excess fluid can lead to unhealthy pressure buildup. For example, glaucoma is a progressive eye disease characterized by elevated intraocular pressure. Aqueous humor is the fluid that fills the anterior chamber (AC) of the eye and contributes to intraocular pressure, or intraocular fluid pressure. This elevated intraocular pressure is usually caused by an insufficient amount of aqueous humor being absorbed into the body. In some cases, aqueous humor is not absorbed quickly enough, or even at all, while in other instances, aqueous humor is additionally or alternatively produced too quickly. The elevated intraocular pressure gradually progresses in the affected eye, sometimes accompanied by permanent vision loss. Summary of the Invention

[0005] Abstract Disclosed herein are devices for draining fluid from the eye to the periocular tissue, as well as methods of forming such devices and methods of using such devices to treat glaucoma.

[0006] According to one example ("Example 1"), a drainage device for draining fluid from an eye to tissue external to the eye is disclosed, the drainage device being at least partially implantable within the tissue of the eye. The device includes a body portion including a membrane having a first surface with a first porosity and a second surface with a second porosity greater than the first porosity, the second surface facing the first surface, and a plate having a porosity less than the first porosity. The membrane is more flexible than the plate, the membrane having a first thickness of about 25 μm to about 125 μm, and the plate having a second thickness of about 0.8 mm to about 2.0 mm. The membrane and the plate define a reservoir in the body portion. The device also includes a conduit fluidly coupled to the reservoir and having an end insertable into the eye to facilitate drainage of fluid into the conduit. The second surface of the membrane having a second porosity includes at least one ingrowth surface area for promoting ingrowth of tissue external to the eye.

[0007] In addition to Example 1, according to another example ("Example 2"), the plate is non-porous.

[0008] In addition to Examples 1 or 2, according to another example ("Example 3"), the plate includes one or more of silicone or polypropylene.

[0009] In addition to any of the preceding examples, according to another example ("Example 4"), the membrane comprises one or more of expanded polytetrafluoroethylene (ePTFE), expanded polyethylene (ePE), silicone, polysulfone, polyvinylidene fluoride (PVDF), polyhexafluoropropylene (PHFP), perfluoroalkoxy polymer (PFA), polyolefin, fluorinated ethylene propylene (FEP), or an acrylic copolymer.

[0010] According to another example ("Example 5"), in addition to any of the previous examples, the device further includes an adhesive disposed between the membrane and the plate.

[0011] In addition to Example 5, according to another example ("Example 6"), the adhesive is a thermoplastic resin.

[0012] According to one example ("Example 7"), a drainage device for draining fluid from an eye to tissue external to the eye is disclosed. The drainage device is at least partially implantable within the tissue of the eye and includes a body portion. The body portion includes a membrane configured to allow fluid from the eye to pass therethrough and having a porosity configured to inhibit ingrowth of tissue external to the eye, and a plate having a porosity less than that of the membrane. The membrane is more flexible than the plate, and the membrane has a first thickness of about 25 μm to about 125 μm, and the plate has a second thickness of about 0.8 mm to about 2.0 mm. The membrane and the plate define a reservoir in the body portion. The device further includes a conduit fluidly coupled to the reservoir and having an end insertable into the eye to facilitate drainage of fluid into the conduit.

[0013] In addition to Example 7, according to another example ("Example 8"), the plate is non-porous.

[0014] In addition to Examples 7 or 8, according to another example ("Example 9"), the plate includes one or more of silicone or polypropylene.

[0015] In addition to any of Examples 7-9, according to another example ("Example 10"), the membrane comprises one or more of expanded polytetrafluoroethylene (ePTFE), expanded polyethylene (ePE), silicone, polysulfone, polyvinylidene fluoride (PVDF), polyhexafluoropropylene (PHFP), perfluoroalkoxy polymer (PFA), polyolefin, fluorinated ethylene propylene (FEP), or an acrylic copolymer.

[0016] According to another example ("Example 11") in addition to any of Examples 7-10, the device further includes an adhesive disposed between the membrane and the plate.

[0017] In addition to Example 11, according to another example ("Example 12"), the adhesive is a thermoplastic resin.

[0018] According to one example ("Example 13"), a drainage device for draining fluid from an eye to tissue external to the eye is disclosed, the drainage device being at least partially implantable within ocular tissue and including a body portion including a membrane having a first surface with a first porosity and a second surface with a second porosity greater than the first porosity, the second surface facing the first surface, and a plate having a porosity less than the first porosity. The membrane has a first thickness of about 25 μm to about 125 μm, and the plate has a second thickness of about 0.05 μm to about 10 μm, and the membrane and plate define a reservoir in the body portion. The device includes a conduit at least partially defined by the membrane and the plate, the conduit being fluidly coupled to the reservoir and insertable into the eye to facilitate drainage of fluid into the conduit. A second surface of the first body component having the second porosity includes at least one ingrowth surface area for promoting ingrowth of tissue external to the eye.

[0019] In addition to Example 13, according to another example ("Example 14"), the plate is non-porous.

[0020] In addition to Examples 13 or 14, according to another example ("Example 15"), the plate includes one or more of silicone or polypropylene.

[0021] In addition to any of Examples 13-15, according to another example ("Example 16"), the membrane comprises one or more of expanded polytetrafluoroethylene (ePTFE), expanded polyethylene (ePE), silicone, polysulfone, polyvinylidene fluoride (PVDF), polyhexafluoropropylene (PHFP), perfluoroalkoxy polymer (PFA), polyolefin, fluorinated ethylene propylene (FEP), or an acrylic copolymer.

[0022] According to another example ("Example 17") in addition to any one of Examples 13-16, the device further includes an adhesive disposed between the membrane and the plate.

[0023] In addition to Example 17, according to another example ("Example 18"), the adhesive is a thermoplastic resin.

[0024] According to one example ("Example 19"), a drainage device for draining fluid from an eye to tissue external to the eye is disclosed, the drainage device being at least partially implantable within the tissue of the eye and including a collapsible body portion, the collapsible body portion including a first body component having a first surface with a first porosity and a second surface having a second porosity greater than the first porosity, the second surface facing the first surface, and a second body component having a third porosity less than the first porosity. The first and second body components define a reservoir of the collapsible body portion. The device further includes a conduit fluidly coupled to the reservoir and insertable into the eye, thereby facilitating drainage of fluid into the conduit, the conduit having an end. The second surface of the first body component having the second porosity includes at least one ingrowth surface area for promoting ingrowth of tissue external to the eye.

[0025] In addition to Example 19, according to another example ("Example 20"), the second body component is non-porous.

[0026] In addition to Examples 19 or 20, according to another example ("Example 21"), the second body component includes one or more of silicone or polypropylene.

[0027] According to another example ("Example 22") in addition to any of Examples 19 to 21, the second body component has a higher stiffness than the first body component.

[0028] In addition to any of Examples 19-22, according to another example ("Example 23"), the first body component comprises one or more of expanded polytetrafluoroethylene (ePTFE), expanded polyethylene (ePE), silicone, polysulfone, polyvinylidene fluoride (PVDF), polyhexafluoropropylene (PHFP), perfluoroalkoxy polymer (PFA), polyolefin, fluorinated ethylene propylene (FEP), or an acrylic copolymer.

[0029] According to another example ("Example 24") in addition to any of Examples 19-23, the device further includes an adhesive disposed between the first body component and the second body component.

[0030] In addition to Example 24, according to another example ("Example 25"), the adhesive is a thermoplastic resin.

[0031] According to one example ("Example 26"), a drainage device for draining fluid from an eye to tissue external to the eye is disclosed, the drainage device being at least partially implantable within the tissue of the eye and including a body portion, the body portion including a first body component having a first surface with a first porosity and a second surface with a second porosity greater than the first porosity, the second surface facing the first surface, and a second body component having a third porosity less than the first porosity and defining a reservoir for the body portion. The first surface of the first body component is attached to an outer surface of the second body component. The device further includes a conduit fluidly coupled to the reservoir and having an end insertable into the eye to thereby facilitate drainage of fluid into the conduit. The second surface of the first body component having the second porosity includes at least one ingrowth surface area for promoting ingrowth of tissue external to the eye, and the first surface of the first body component having the first porosity is configured to inhibit ingrowth of tissue external to the eye.

[0032] In addition to Example 26, according to another example ("Example 27"), the second body component includes multiple subcomponents joined together.

[0033] According to another example ("Example 28") in addition to Example 26 or 27, the device further includes an open-ended valve enclosed by the body portion, the valve fluidly coupled to the conduit and partially defining the reservoir.

[0034] According to another example ("Example 29") in addition to any of Examples 26-28, the first surface having the first porosity is configured to inhibit ingrowth of tissue outside the eye.

[0035] According to another example ("Example 30") in addition to any of Examples 26-29, the second surface further comprises at least one low porosity region for inhibiting ingrowth of tissue outside the eye.

[0036] According to another example ("Example 31") in addition to any of Examples 26-30, the first body component includes a plurality of interior regions having a porosity greater than the first porosity and less than the second porosity.

[0037] According to another example ("Example 32") in addition to any of Examples 26-31, the conduit is attached to a periphery of the body portion.

[0038] According to another example ("Example 33") in addition to any of Examples 26-31, the conduit is attached to the body portion over a portion of the cross-sectional length of the body portion.

[0039] The foregoing examples are exemplary only and should not be construed as limiting or narrowing the scope of the inventive concepts otherwise provided by this disclosure. While multiple embodiments are disclosed, still other embodiments will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. [Brief explanation of the drawings]

[0040] BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings are included to provide a further understanding of the present disclosure, and are incorporated in and constitute a part of this specification, illustrating embodiments and, together with the description, serve to explain the principles of the present disclosure.

[0041] [Figure 1A] FIG. 1A is a schematic diagram of a cross section of a discharge device according to an embodiment disclosed herein. [Figure 1B] FIG. 1B is a schematic diagram of a cross section of a discharge device according to an embodiment disclosed herein.

[0042] [Figure 1C] FIG. 1C is an SEM image of a portion of a cross section of a discharge device according to an embodiment disclosed herein (the image is to the scale shown in the image).

[0043] [Figure 1D] FIG. 1D is a schematic illustration of a cross section of an eye with a drainage device at least partially implanted therein according to an embodiment disclosed herein.

[0044] [Figure 1E] FIG. 1E is a microscopic image of a tissue slide stained with a histological stain showing a cross section of a drainage device according to an embodiment disclosed herein (image is to the scale shown in the image).

[0045] [Figure 2A] FIG. 2A is a schematic diagram of a bottom view of a discharge device according to an embodiment disclosed herein. [Figure 2B] FIG. 2B is a schematic illustration of a top view of a discharge device according to an embodiment disclosed herein.

[0046] [Figure 2C] FIG. 2C is a schematic cross-sectional view of a discharge device according to an embodiment disclosed herein taken along line C / DC / D of FIG. 2B. [Figure 2D] FIG. 2D is a schematic cross-sectional view of a discharge device according to an embodiment disclosed herein taken along line C / DC / D of FIG. 2B.

[0047] [Figure 3A] FIG. 3A is a schematic diagram of a bottom view of a discharge device according to an embodiment disclosed herein. [Figure 3B] FIG. 3B is a schematic illustration of a top view of a discharge device according to an embodiment disclosed herein.

[0048] [Figure 3C] FIG. 3C is a schematic cross-sectional view of a discharge device according to an embodiment disclosed herein taken along line C / DC / D of FIG. 3B. [Figure 3D]FIG. 3D is a schematic cross-sectional view of a discharge device according to an embodiment disclosed herein taken along line C / DC / D of FIG. 3B.

[0049] [Figure 4A] FIG. 4A is a schematic diagram of a bottom view of a discharge device according to an embodiment disclosed herein. [Figure 4B] FIG. 4B is a schematic illustration of a top view of a discharge device according to an embodiment disclosed herein.

[0050] [Figure 4C] FIG. 4C is a schematic cross-sectional view of a discharge device according to an embodiment disclosed herein taken along line CC of FIG. 4B.

[0051] [Figure 5A] FIG. 5A is a top view of a discharge device according to an embodiment disclosed herein.

[0052] [Figure 5B] 5B is a cross-sectional view of the ejection device of FIG. 5A taken along line 5B-5B of FIG. 5A.

[0053] [Figure 5C] FIG. 5C is an enlarged view of a portion of the cross-sectional view of the ejection device of FIG. 5B.

[0054] [Figure 6A] FIG. 6A is a top view of a discharge device according to an embodiment disclosed herein.

[0055] [Figure 6B] 6B is a cross-sectional view of the ejection device of FIG. 6A taken along line 6B-6B of FIG. 6A.

[0056] [Figure 6C] FIG. 6C is an enlarged view of a portion of the cross-sectional view of the ejection device of FIG. 6B.

[0057] [Figure 7A] FIG. 7A (Prior Art) is a top view of a prior art glaucoma drainage device.

[0058] [Figure 7B] FIG. 7B (Prior Art) is a side view of the prior art glaucoma drainage device of FIG. 7A.

[0059] [Figure 7C] FIG. 7C (Prior Art) is a perspective view of the prior art glaucoma drainage device of FIG. 7A.

[0060] [Figure 8A] FIG. 8A (Prior Art) is a top view of several prior art glaucoma devices having solid, rigid plates. [Figure 8B] FIG. 8B (Prior Art) is a top view of several prior art glaucoma devices having solid, rigid plates. [Figure 8C] FIG. 8C (Prior Art) is a top view of several prior art glaucoma devices having solid, rigid plates.

[0061] [Figure 9A] FIG. 9A (Prior Art) is a top view of an Ahmed® glaucoma valve modified with a polyethylene shell and solid plate as known in the prior art.

[0062] [Figure 9B] FIG. 9B (Prior Art) is a side view of the prior art glaucoma valve of FIG. 9A with a portion of the solid plate removed to reveal the reservoir located therein.

[0063] [Figure 9C] FIG. 9C (Prior Art) is a scanning electron microscope (SEM) image of a portion of the surface of a solid plate used in the prior art glaucoma valve of FIG. 9A (the image is to scale as shown in the image).

[0064] It should be understood that, unless otherwise noted, the drawings and photographic reproductions are not necessarily to scale. In certain instances, details that are not necessary for an understanding of the present disclosure or that obscure other details may have been omitted. Of course, it should be understood that the present disclosure is not necessarily limited to the specific examples or embodiments shown or depicted herein. DETAILED DESCRIPTION OF THE INVENTION

[0065] Detailed Description Definitions and Terminology This disclosure is not intended to be read in a restrictive manner. For example, the terms used in this application should be interpreted broadly in accordance with the meaning that one of ordinary skill in the art would assign to such terms.

[0066] With respect to terms related to imprecision, the terms "about" and "approximately" may be used interchangeably to refer to measurements, including the stated measurement and measurements reasonably close to the stated measurement. A measurement reasonably close to the stated measurement deviates from the stated measurement by a reasonably small amount, to the extent that it would be understood and readily grasped by one of ordinary skill in the relevant art. Such deviations may result from, for example, measurement error, differences in the calibration of measuring and / or manufacturing equipment, human error in reading and / or setting measurements, fine-tuning made to optimize performance and / or structural parameters to account for variations in measurements associated with other components, specific implementation scenarios, imprecise adjustment and / or manipulation of objects by humans or machines, and / or the like. If it is determined that the value of such reasonably small differences would not be readily grasped by one of ordinary skill in the relevant art, the terms "about" and "approximately" may be understood to mean plus or minus 10% of the stated value.

[0067] The words "at least one," "one or more," and "and / or" are open-ended expressions that function as both conjunctions and disjunctions. For example, the expressions "at least one of A, B, and C," "at least one of A, B, or C," "one or more of A, B, and C," "one or more of A, B, or C," and "A, B, and / or C" mean A alone, B alone, C alone, A and B together, A and C together, B and C together, or A, B, and C together, respectively. A, B, and C in the above expressions can be elements such as X, Y, and Z, or X1-X. n , Y1-Y m , Z1-Z o When referring to a class of elements such as X, Y, and Z, the phrase refers to a single element selected from X, Y, and Z, a combination of elements selected from the same class (e.g., X1 and X2), and a combination of elements selected from two or more classes (e.g., Y1 and Z). o ) is intended to refer to

[0068] It is to be understood that every maximum numerical limitation given throughout this disclosure is intended to include in the alternative every lower numerical limitation, as if such lower numerical limitations were expressly written herein. Every minimum numerical limitation given throughout this disclosure is intended to include in the alternative every higher numerical limitation, as if such higher numerical limitations were expressly written herein. Every numerical range given throughout this disclosure is intended to include every narrower numerical range that is included within such broader numerical range, as if such narrower numerical ranges were all expressly written herein.

[0069] Before describing any embodiments of the present disclosure in detail, it is to be understood that the disclosure is not limited in its application to the details of construction and the arrangements of components set forth in the following description or illustrated in the following drawings. The disclosure is capable of other embodiments and of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. As used herein, "including," "comprising," or "having" and variations thereof are intended to encompass the items listed thereafter and equivalents thereof, as well as additional items.

[0070] As used herein, the term "fibril" refers to an elongated piece of material, such as a polymer, whose length and width are substantially different from one another. For example, a fibril can resemble a string or piece of fiber, whose width (or thickness) is much shorter or less than its length.

[0071] As used herein, the term "node" refers to a connection point of at least two fibrils, where a connection can be defined as a location where two fibrils make permanent or temporary contact with one another. In some instances, a node may also be used to describe a polymer that is larger in volume than a fibril, where a fibril begins or ends without a distinct succession of the same fibril through the node. In some instances, a node is wider but shorter in length than a fibril.

[0072] As used herein, "nodes" and "fibrils" may be used to describe objects that are typically, but not necessarily, connected or interconnected, e.g., having microscopic sizes. A "microscopic" object may be defined as an object that is substantially small in at least one dimension (width, length, or height) such that the object or details thereof are not visible to the naked eye or are difficult, if not impossible, to observe without the aid of a microscope (e.g., including, but not limited to, a scanning electron microscope (SEM)) or any suitable type of magnifying device).

[0073] Description of Various Embodiments Various embodiments as disclosed herein relate to drainage devices that can be implanted within the eye to provide a means for draining such fluid from the AC of the eye and avoiding or preventing hypotony, which address various problems and challenges faced by prior art drainage devices currently used in the art, as further described below.

[0074] Some conventional drainage devices include a solid shell or plates, such as those made of silicone as shown in Figures 7A-C and 8A-C, or a porous shell, such as those made of polyethylene as shown in Figures 9A-C, that can receive fluid from the AC of the eye and store it in an internal chamber formed between the plates.

[0075] Figures 7A-C show a glaucoma drainage device as known in the art. The device includes a plate body "B" that defines a surface through which drained fluid (aqueous humor) flows and a drainage tube "T" that directs the fluid (aqueous humor) along the surface of the plate body. The implanted plate body B (Figures 7A-C and 8A-C) defines a surface area where fluid is absorbed by surrounding tissue, more specifically, conjunctival tissue above the plate body. In the art, this surface area is referred to as a "bleb," and the absorption of redirected fluid into the surroundings is also referred to as filtration through tissue; therefore, these devices are sometimes referred to as "filtering" devices. Plate body B has a maximum thickness "t1," which in the illustrated example is 2.1 mm. It is made of medical-grade silicone and is not flexible enough to conform to the curvature of the eye during implantation. Therefore, plate body B has a preformed curvature (defined by dashed line CC in Figure 7B) that approximates the curvature of the surface of the eye. This curvature CC is fixed and the same for all glaucoma drainage devices and therefore cannot accommodate the unique curvature of each patient's eye. Plate body B also includes embedded therein a valve "V" with an outlet "OL" that directs fluid from tube T to a groove "G" located on the outer surface of plate body B, as shown in FIG. 7C.

[0076] In the prior art device of FIGS. 7A-C , i.e., the Ahmed® Glaucoma Valve Model FP7 (New World Medical, Inc., Rancho Cucamonga, California), plate body B has a rigid structure that allows a user to grasp any portion of plate body B with an instrument, such as medical tweezers, hemostat, or other appropriate medical instrument. While grasping plate body B with the medical instrument, the user can push plate body B into the ocular tissue pocket formed by the incision. Similarly, the prior art device of FIGS. 7A-C relies on a slippery or low-friction surface of the device to facilitate the surgeon or practitioner's insertion of the device by pushing it into the ocular tissue pocket. Therefore, a device with high surface friction encounters resistance to the pushing action, increasing the likelihood of the device deforming and collapsing (e.g., bending, folding, buckling, deforming, or crumpling) during the implantation procedure.

[0077] In the aforementioned Ahmed® model, Plate Body B is made of medical-grade silicone, and the casing of Valve V is made of medical-grade polypropylene. Because Plate Body B, made of solid silicone, does not integrate with the surrounding tissue upon implantation, this lack of integration results in poor tissue response to relieve stress from the pressure imposed by Plate Body B, leading to fibrosis of Plate Body B and resulting in a high complication rate for several years after device implantation. This is further explained in Christakis PG et al., "The Ahmed Versus Baerveldt Study: Five-Year Treatment Outcomes." Ophthalmology. 2016 Oct;123(10):2093-102. DOI: 10.1016 / j.ophtha.2016.06.035. Epub 2016 Aug 17 PMID: 27544023. For example, Figure 2 in the same publication shows the cumulative failure rates of the Ahmed® model and the Baerveldt® glaucoma implant device model 101-350. Thus, in contrast to prior art devices, integration with the surrounding tissue helps reduce fibrosis and other problems after the drainage device implant procedure.

[0078] 8A-C show other prior art devices, each including a plate body B and a tube T extending therefrom. The devices shown are Baerveldt® Glaucoma Implant Devices (Johnson & Johnson Surgical Vision, Inc., Irvine, California), e.g., models BG 102-350 (FIG. 8A), BG 103-250 (FIG. 8B), and BG 101-350 (FIG. 8C). Plate body B is molded with a predetermined curvature to generally match the curvature of the eye in which the device is to be implanted, but the curvature is not customized for the patient's particular eye. Plate body B is made of a material, such as a silicone plate impregnated with barium sulfate. Like the Ahmed® device of FIGS. 7A-C, the solid silicone plate body of the Baerveldt® device also fails to provide a means for integrating plate body B with surrounding tissue, leading to similar problems and complications. The aforementioned document, "Ahmed vs. Baerveldt Study," also describes high failure rates of Baerveldt® devices, such as the model BG 101-350. Additional devices that fall into a similar category and may therefore involve issues similar to those described above include the Ahmed ClearPath® (New World Medical, Inc., Rancho Cucamonga, California), Molteno3® (Nova Eye Medical Ltd., Fremont, California), the PAUL® Glaucoma Implant (Advanced Ophthalmic Innovations Pte Ltd., Singapore), eyePlate® (Rheon Medical SA, Switzerland), the Keiki Mehta "BP Valve" Glaucoma Shunt (G. Surgiwear Ltd., India), and Aurolab Aqueous Drainage Implants ("AADI," Aurorab, India).

[0079] Another prior art device shown in Figures 9A and 9B is the Ahmed® Glaucoma Valve Model M4 (New World Medical, Inc., Rancho Cucamonga, CA), which employs a polyethylene shell to reduce fibrotic responses around the drainage plate in glaucoma patients compared to the S2 and FP7 models, as previously disclosed in Kim J, Allingham RR, Hall J, et al., "Clinical experience with a novel glaucoma drainage implant," Journal of Glaucoma. 2014 Feb; 23(2):e91-7. DOI: 10.1097 / ijg.0b013e3182955d73 PMID: 23689073. This prior art device includes a body shell B and a tube T disposed between two layers (L1 and L2) of a solid material, such as a porous polyethylene shell (e.g., Medpor), that is not customized for a patient's particular eye but generally conforms to the curvature of the eye. Layers L1 and L2 define a reservoir "R" through which the tube T directs fluid from the eye. As shown in Figure 9C (scaled so that the black bar at the bottom of the figure represents 500 μm), the surfaces of layers L1 and L2 of the prior art device include pores to enhance tissue integration. This allows adjacent tissue to integrate with the polyethylene shell surrounding the drainage device. It also ensures that fluid stored within reservoir R is released into the surrounding environment, preventing the shell from placing undue stress on the surrounding tissue. The implanted body shell B (Figures 9A-C) defines a surface area where fluid can be absorbed by surrounding tissue, more specifically, the conjunctival tissue above the plate body.

[0080] In the Ahmed® device of Figures 9A-C, the solid porous polyethylene shell formed using two layers of porous material, L1 and L2, attempts to integrate the shell body with surrounding tissue. However, in a manner that promotes integration, the porous shell allows surrounding tissue to infiltrate the interior (e.g., reservoir R), resulting in tissue coating the interior of the shell, reducing the effective surface area of ​​the bleb through which filtration occurs and potentially clogging the reservoir R and / or tube T, leading to device failure. These issues are further discussed in Sluch I, et al., "Clinical Experience with the M4 Ahmed Glaucoma Drainage Implant." J Curr Glaucoma Pract. 2017 Sep-Dec;11(3):92-96 DOI: 10.5005 / jp-journals-10028-1231. Epub 2017 Oct 27. PMID: 29151683; PMCID: PMC5684239. For example, Figure 3 in the literature shows that the survival rate of the M4 model declines over time. Here, survival refers to the patient continuing the study without experiencing a surgical failure. Therefore, the issues discussed above must be overcome for the devices shown in Figures 7A-C, 8A-C, and 9A-C.

[0081] Various embodiments and examples of drainage devices 100 for treating glaucoma are disclosed herein. For example, FIG. 1A illustrates an example of device 100. As shown, device 100 is an implantable device that can be used to drain fluid from the eye when at least partially implanted within ocular tissue. In some examples, the fluid can be drained to tissue surrounding the eye or to tissue external to the eye. Device 100 includes a body portion 101 and a fluid conduit 104. Body portion 101 is formed using a first body component 102 and a second body component 103, with first body component 102 having a first surface 106 with a first porosity and a second surface 108 with a second porosity greater than the first porosity. Second surface 108 faces first surface 106 (or is located at a position on first body component 102 opposite the position of first surface 106). The second body component 103 can have a third porosity that is less than both the first porosity and the second porosity of the first body component 102. In some examples, the second body component 103 can be non-porous. In some examples, the first body component 102 may be referred to as a membrane and the second body component 103 may be referred to as a plate.

[0082] Body portion 101 further includes a reservoir 105 fluidly coupled to lumen 114 of conduit 104 such that a first end 110 of conduit 104 is disposed within reservoir 105 and a second end 112 of conduit 104 is disposed outside reservoir 105. In some examples, in forming reservoir 105, first body component 102 and second body component 103 may be heat treated or sintered to fuse or bond them together around their peripheries. In some examples, second body component 103 is subjected to a heat treatment, and second body component 103 may be made using a material, such as silicone, that has a lower melting point than the material of first body component 102, thereby fusing second body component 103 to first body component 102.

[0083] In some examples, the thickness of main body portion 101 can be about 25 μm to about 30 μm, about 30 μm to about 40 μm, about 40 μm to about 50 μm, about 50 μm to about 60 μm, about 60 μm to about 70 μm, about 70 μm to about 80 μm, about 80 μm to about 90 μm, about 90 μm to about 100 μm, about 10 μm to about 150 μm, about 150 μm to about 200 μm, about 200 μm to about 250 μm, about 250 μm to about 300 μm, about 300 μm to about 350 μm, about 350 μm to about 400 μm, about 400 μm to about 450 μm, about 450 μm to about 500 μm, or any other suitable value or range therebetween and / or combinations of ranges therebetween. In some examples, the body portion 101 can have a diameter ranging from about 5 mm to about 15 mm, e.g., about 10 mm. In some embodiments, the body portion 101 is oval-shaped, with a major axis (e.g., along the major axis of the ellipse) of up to about 30 mm and a corresponding minor axis (e.g., along the minor axis of the ellipse) of up to about 10 mm. As discussed above, given the various anatomical structures of the human body, the body portion 101 may exceed the above dimensions (e.g., 10 mm, 15 mm, and 30 mm) as long as the size does not substantially interfere with normal ocular function (e.g., turning and blinking) or substantially reduce the flexibility of the aqueous humor diffusion member. Otherwise, implantation of the drainage device 100 may result in undesirable relative movement between the drainage device 100 and surrounding tissue, potentially resulting in tissue irritation, foreign body tissue reaction, and / or excessive scarring. Similarly, the body portion 101 can be less than about 5 mm in diameter, or even less than 3 mm, provided that it is capable of adequately containing the drained aqueous humor and operable to promote reabsorption of the aqueous humor to provide effective treatment for the patient.

[0084] In some examples, first body component 102 is a membrane having a thickness of about 25 μm to about 50 μm, about 50 μm to about 75 μm, about 75 μm to about 100 μm, about 100 μm to about 125 μm, or any other suitable value or range therebetween, or a combination of any suitable ranges thereof. Second body component 103 is a plate having a thickness of about 0.8 mm to about 1.0 mm, about 1.8 mm to about 1.2 mm, about 1.2 mm to about 1.4 mm, about 1.4 mm to about 1.6 mm, about 1.6 mm to about 1.8 mm, about 1.8 mm to about 2.0 mm, or any other suitable value or range therebetween, or a combination of any suitable ranges thereof.

[0085] In some instances, first body component 102 is a membrane having sufficient porosity to allow fluid from the eye to pass through the membrane and to reduce or inhibit ingrowth of tissue outside the eye. First body component 102 can be more flexible than second body component 103, which is a plate, such that body components 102 and 103 have different thicknesses as described above.

[0086] The conduit 104 can be a tube or any suitable structure that allows the passage of fluid. The second end 112 of the conduit 104 is insertable into a patient's eye, thereby facilitating the drainage of bodily fluid into the conduit 104. Throughout the figures disclosed herein, dashed arrows represent the general direction in which fluid may flow relative to the components of the device 100. For example, in FIG. 1A , fluid enters the lumen 114 of the conduit 104 via the second end 112, passes through the lumen 114, and then exits the first end 110. The fluid then fills the reservoir 105, expanding it as shown in FIG. 1B, and can then pass through the material of the first body component 102 and exit the body portion 101 at the second surface 108 to the surrounding environment. In some instances, first body component 102 is more flexible than second body component 103, which in some instances can be rigid or hard, although semi-rigid or flexible second body components are also contemplated. Thus, in some instances, when reservoir 105 is expanded with fluid, only first body component 102 changes shape, transitioning from an empty state ( FIG. 1A ) to a filled state ( FIG. 1B ) as shown. In some instances, both first body component 102 and second body component 103 are sufficiently flexible such that body portion 101 can be collapsible. Second surface 108 having a second porosity also includes at least one ingrowth surface region 118 that promotes tissue ingrowth, as shown in FIG. 1C .

[0087] FIG. 1C shows a micrograph of a microporous material on the outer surface (second surface 108) of the first body component 102, according to some embodiments. The first body component 102 includes a plurality of interior regions 116 between the first surface 106 and the second surface 108, each having a porosity greater than the first porosity and less than the second porosity. The bottom of FIG. 1C is labeled "5.00 kV 4.2 mm x 500 SE 1 / 23 / 2018," with the distance between two consecutive lines in the lower right corner representing 10 μm. For example, the microporous material of FIG. 1C may be referred to throughout this specification in connection with a medical implant device or system. As one skilled in the art can appreciate with reference to FIG. 1C, the microporosity and parameters of a microporous material can be defined in a variety of ways. In the application of microporous materials in ophthalmic devices configured for in situ placement within eye tissue to promote drainage of bodily fluids from the eye, such as the device 100 described herein (showing the direction of fluid flow relative to the first surface 106 and the second surface 108 as indicated by the white arrows labeled "Fluid Flow"), the microporous properties of such microporous materials can generally be characterized by a volumetric porosity value, which can be defined as the ratio of the volume of air or fluid defined by and trapped within the microporous material to the overall volume (or total volume) of the microporous material.

[0088] In another definition, volumetric porosity can be defined as the percentage of the volume of a microporous material that is occupied by non-structural or transient elements such as air or other fluids. For example, if the total volume is 100 mm 3 And 30mm of that 3 A microporous material that contains chambers that hold air or fluids has a volumetric porosity value of 0.3 because 30% of the volume of the microporous material is voids or temporary spaces filled with air or other fluids.

[0089] As will be appreciated, two microporous materials can have the same volumetric porosity but different pore sizes presented to the inflow or outflow of air or fluid. For example, a first material can have a small number of large pores distributed over a given overall volume, and a second material can have a larger number of relatively small pores distributed over the same given volume; if the air / fluid volumes of the two materials are the same, then both microporous materials can have the same volumetric porosity.

[0090] As can be further appreciated, the properties of microporous materials used in ophthalmic drainage devices can also be defined by the size of the passageways through the microporous material, or equivalently, the pore size measured where the passageways terminate at the surface of the microporous material, or the pore size measured along the length of the passageway within the material. Microporous materials with small pores or passageways can impede flow through the material, while relatively large pores or passageways can increase the passage of air or fluid into, out of, or within the microporous material.

[0091] As can be further appreciated, the properties of a microporous material can also be defined by the tortuosity of the passages into and through the material, with relatively small or large passages obstructing the fluid path by the frequency of tortuosity within the passage or the placement of obstacles within the fluid passage. The air / fluid passage rate through a microporous material can be managed by controlling or defining any of the material properties described above, providing a material suitable for use in facilitating the drainage of bodily fluids from the eye.

[0092] For simplicity, the above-mentioned properties and variables of the microporous materials used in the various embodiments and examples described herein can be expressed simply as porosity, which can be based on volumetric porosity, pore or passage size, or tortuosity. Referring again to Figure 1C, the interior portion of the microporous material can have a variety of porosity (or volumetric porosity, pore size, or tortuosity). The interior portion can extend between an interior surface (first surface 106) and an exterior surface (second surface 108).

[0093] In any of these portions of the first body component 102, the porosity can be in a comparable range of small pore size (SP), medium-small pore size (MSP), medium pore size (MP), medium-large pore size (MLP), and large pore size (LP), with LP being larger than MLP, MLP being larger than MP, MP being larger than MSP, and MSP being larger than SP. In some examples, the size of the SP can range from about 0.01% to 2% of the size of the LP, about 2% to 5% of the MSP, about 5% to 20% of the MP, and about 20% to 80% of the MLP. The size of the SP can range from about 0.01 μm to about 1 μm in pore diameter (or average pore size). In some examples, as the pore size increases from one category to the next (e.g., from SP to MSP, or from MSP to MP), the porosity can increase by about 5 to 10 times. For purposes of this discussion, assuming delivery travels along a relatively straight path through the microporous material, sequentially encountering the porosities of the inner surface 106, the uniform interior portion, and the exterior surface 108, the composite flow resistance can be expressed by similarly combining the respective porosities. For example, the inner surface 106 typically has low porosity throughout (e.g., to resist tissue ingrowth through the first body component 102 and / or to maintain a plane between the device 100 and the sclera), while portions of the inner portion and the exterior surface 108 can have any of the aforementioned degrees of porosity. Under these circumstances, when the inner portion has a medium porosity, e.g., when the inner portion has a medium porosity and the exterior surface 108 has a high porosity, the drainage of fluid from the eye through the microporous material and into the tissue surrounding the device can be expressed as SP-MP-LP. More examples are provided below.

[0094] Various delivery flow paths can exist within a microporous material. Relatively linear flow paths can include, for example, SP1-SP4-SP5 regions or SP3-MLP1-MP1-MSP1 regions. While some flow paths can be relatively linear, non-linear flow paths also exist. For example, under certain conditions, at least some flow can proceed through regions of gradually decreasing resistance, such as SP1-LP1-LP2 or SP3-MLP1-LP1-LP2. As will be appreciated, the microstructure of a microporous material can undergo a modification process to achieve a particular type of flow through the microstructure. For example, the microstructure can have relatively uniform layers layered across the microstructure, or, as shown here, can have variable portions throughout the thickness of the microporous material.

[0095] In some examples, the first body component 102 defines a wall thickness extending between the inner surface 106 and the outer surface 108. The wall thickness can define an interior region of the first body component 102 having a transitional porosity between the porosity of the low-porosity surface (e.g., having a smaller pore size) of the inner surface 106 and the porosity of the high-porosity surface (e.g., having a larger pore size) of the outer surface 108. Additionally or alternatively, the interior region can have an interior region porosity equal to the porosity of the low-porosity surface of the inner surface 106 and the outer surface 108. Additionally or alternatively, the interior region can have an interior region porosity equal to the porosity of the low-porosity surface of the inner surface 106. Additionally or alternatively, the interior region can have an interior region porosity equal to the porosity of the high-porosity surface of the outer surface 108.

[0096] 1C , the fluid pathway can also be affected by a pressure difference between a fluid in one region (e.g., the first surface 106) and a fluid in another region (e.g., the second surface 108). In some instances, the first surface 106 has a first porosity that prevents or inhibits tissue ingrowth. In some instances, the second surface 108 includes at least one low porosity region 120 for inhibiting tissue ingrowth. Regions that can inhibit tissue ingrowth can have relatively small pore sizes, such as SPs and / or MSPs.

[0097] Various embodiments of the present disclosure relate to devices and methods for draining bodily fluids. For example, the present disclosure relates to devices and methods for draining aqueous humor from the anterior chamber (AC) (FIG. 1D) of a patient's eye so that the aqueous humor can be reabsorbed elsewhere in the body. FIG. 1D is a diagram of an eye including the subconjunctival space between the conjunctiva and sclera of the eye. A drainage system including a drainage device 100 according to the principles of the present disclosure is implanted within the eye. In one embodiment of the present disclosure, a mechanism is provided for reabsorbing aqueous humor drained from the anterior chamber of the eye to reduce or stabilize intraocular pressure. However, those skilled in the art will appreciate that embodiments of the present disclosure are useful for other applications in which drainage of bodily fluids that are redirected within the body is desired. In some instances, the target implantation site can include the subconjunctival and / or sub-Tenon regions of the eye. In some instances, the device 100 can be implanted at least partially subconjunctivally and at least partially suprachoroidally (e.g., posterior to the pars plana of the eye) as appropriate for the intended treatment.

[0098] As described above, in various embodiments, the fluid conduit is a flexible, compliant tubular member that can be inserted into the anterior chamber of the eye. In various exemplary surgical approaches, one or more of the fluid conduit and aqueous humor diffusion member are advanced or pushed during the implant procedure. Soft, thin, compliant tubular structures are generally difficult to advance through tissue. Thus, in various embodiments, the glaucoma drainage devices discussed herein can further include internal components that can function as support structures integrated with the device.

[0099] In some instances, as will be appreciated by those skilled in the art, device 100 may be implanted intraocularly (e.g., from inside the eye), for example, through a clear corneal incision and placed in the subconjunctival space through an incision made through the sclera. In other embodiments, as will be appreciated by those skilled in the art, device 100 may be implantable extraocularly (e.g., from outside the eye), for example, through a conjunctival incision. In some embodiments, a radial conjunctival incision may be made (e.g., typically near the limbal border), and blunt dissection of the conjunctiva may be performed to expose the sclera and provide a site for placement of the aqueous humor diffusion element. In some embodiments, this may require suturing the aqueous humor diffusion element to the sclera. In some embodiments, a small needle (e.g., typically a 22-gauge or 23-gauge needle) may be inserted near the scleral promontory to provide a pathway for subsequent insertion and placement of a fluid conduit into the AC. Similarly, it will be appreciated that the above-described fluid conduit implantation procedures may be performed via one or more of an internal clear corneal approach and an external approach.

[0100] FIG. 1E is an exemplary image of a histopathology slide showing the first body component 102 and how the conjunctival tissue of the eye interacts or engages with the first body component 102. A color version of FIG. 1E is provided in U.S. Provisional Application No. 63 / 444,089. In this image, the slide was stained with Masson's Trichrome (a histological stain) at 20x magnification (the bar in the lower right corner indicates a scale of 100 μm). For example, collagen and tissue cells are stained to exhibit different levels of brightness so that they can be visually distinguished. For example, in FIG. 1E, collagen is shown in a lighter shade of gray than the tissue cells (see, e.g., the region within the conjunctiva), while the tissue cells are shown in a darker shade of gray (see, e.g., the tissue cells 122 near the first surface 106 as shown). As shown in FIG. 1E, the layer or band 124 located between the first body component 102 and the conjunctiva contains both tissue cells and collagen at a higher density or concentration than the conjunctiva. It should be understood that the conjunctiva also contains tissue cells, but at a lower concentration than near the first surface 106. The first body component 102 includes a first surface 106 and a second surface 108, the second surface 108 including a plurality of ingrowth surface regions 118 and low-porosity regions 120. The ingrowth surface regions 118 receive tissue cells 122 from the conjunctiva therein to promote the ingrowth of tissue cells 122 into portions of the second surface 108, while the low-porosity regions 120 prevent or substantially inhibit such ingrowth. The first surface 106 is entirely or substantially free of tissue cells or collagen, and while the second surface 108 can at least partially promote the ingrowth of tissue cells and collagen, the first surface 106 prevents or inhibits the ingrowth of tissue cells 122 from outside the eye.

[0101] 2A and 2B show bottom and top views, respectively, of an example of the discharge device 100, and FIGS. 2C and 2D show two examples or embodiments of the discharge device 100 as viewed from the side in cross-sectional views taken along dashed line C / DC / D (CC in the case of FIG. 2C, DD in the case of FIG. 2D).

[0102] In the discharge device 100 of FIG. 2C , an adhesive 200 (or, in some examples, a thermoplastic resin) is disposed between the first body component 102 and the second body component 103, peripherally bonding the two components to form the reservoir 105 of the body portion 101. The adhesive 200 is also disposed between the first body component 102 and the conduit 104. The adhesive 200 may comprise any suitable adhesive polymer material, including, but not limited to, silicone. In some examples, the adhesive 200 is a portion of the second body component 103 that has been heat-treated to fuse the portion of the second body component 103 to the first body component 102. The conduit 104 may be attached to the body portion 101 over a portion of the cross-sectional length of the body portion 101, for example, between 10% and 70% of the cross-sectional length of the body portion 101.

[0103] In the drainage device 100 of FIG. 2D , an open valve 300 is fluidly coupled to the reservoir 105, whereby the valve 300 controls fluid flow through the lumen 114. Also disposed within the reservoir 105 is an inner component 302 between the first body component 102 and the second body component 103. The inner component 302 is a support structure attached to portions of the first body component 102 and the second body component 103. In some examples, the inner component 302 can be a solid material, a solid and microporous material, a solid material with an attached microporous membrane, or can be made of multiple components that are not directly attached to each other, as appropriate, to control the expansion of the device 100, and more specifically, the expansion of the reservoir 105. In some examples, the inner component 302 can be an adhesive similar to the adhesive 200.

[0104] 3A and 3B show bottom and top views, respectively, of an example of the discharge device 100, and FIGS. 3C and 3D show two examples or embodiments of the discharge device 100 as viewed from the side in cross-sectional views taken along dashed lines C / DC / D (CC in the case of FIG. 3C and DD in the case of FIG. 3D).

[0105] 3C , the first body component 102 is disposed on an outer surface of the second body component 103 such that the first body component 102 substantially surrounds or encases the second body component 103. In some examples, the valve 300 at least partially defines the reservoir 105 and is disposed between the reservoir 105 and the conduit 104 to control fluid flow from the lumen 114. Because the first body component 102 does not directly contact the fluid in the reservoir 105, the fluid cannot enter the surrounding environment through the first body component 102.

[0106] In the discharge device 100 of Figure 3D, the second body component 103 includes two subcomponents 103A and 103B, which can be fused or bonded (e.g., fused by heat treatment or sintering, or bonded with an adhesive or thermoplastic, as appropriate) to one another around their peripheries to form the second body component 103. As shown in Figure 3D, at least a portion of the peripheries of the subcomponents 103A and 103B can be sandwiched or pressed together to form, for example, the fused periphery of the body portion 101. In both the examples shown in Figures 3C and 3D, the second body component 103 defines a reservoir 105.

[0107] 4A and 4B show bottom and top views, respectively, of an example drainage device 100, and FIG. 4C shows an example or embodiment of the drainage device 100 in cross section as viewed from the side when cut along dashed line CC. The drainage device 100 in these figures has a body portion 101 including two portions: a plate body 400 and a neck or wick portion 402. The plate body 400 has a width and length that are substantially greater than the neck portion 402. In some examples, the plate body 400 resembles a rectangle, although other suitable shapes may be implemented. The first body component 102 and the second body component 103 can be bonded or fused to the periphery of both the plate body 400 and the neck 402, such that the plate body 400 defines the reservoir 105 and the neck 402 defines the lumen 114. Thus, there is no separate conduit or tube inserted between the first body component 102 and the second body component 103, as both the reservoir 105 and the lumen 114 are defined by the first body component and the second body component 102 and 103.

[0108] 4A-C is a VisiPlate® implant device developed by Avisi Technologies Inc. (Philadelphia, Pennsylvania) for the treatment of glaucoma. Accordingly, second body component 103 can have a thickness that is substantially less than first body component 102. For example, first body component 102 can be a membrane having a thickness of about 25 μm to about 50 μm, about 50 μm to about 75 μm, about 75 μm to about 100 μm, about 100 μm to about 125 μm, or any other suitable value or range therebetween, or any suitable combination of ranges therebetween. The second body component 103 can be a plate having a thickness of about 0.05 μm to about 0.50 μm, about 0.50 μm to about 1.0 μm, about 1.0 μm to about 2.0 μm, about 2.0 μm to about 5.0 μm, about 5.0 μm to about 8.0 μm, about 8.0 μm to about 10.0 μm, or any other suitable value or range therebetween, or any suitable combination of those ranges.

[0109] 5A-C show an example of a device 100 formed by attaching a first body component 102 to the periphery of a second body component 103, where the second body component 103 is an Ahmed® FP7 device shown in FIGS. 7A-C. 6A-C show an example of a device 100 formed by attaching a first body component 102 to the periphery of a second body component 103, where the second body component 103 is a Baerveldt® BG 101-350 device shown in FIG. 8C. The thicknesses of the first body component 102 ("T1") and second body component 103 ("T2") are shown, with adhesive 200 disposed between the peripheries of the two components 102, 103.

[0110] In both of the foregoing examples, reservoir 105 is formed between first body component 102 and second body component 103, with first surface 106 of first body component 102 inhibiting the ingrowth of tissue outside the eye, while second surface 108 of first body component 102 can include at least one growth surface region (e.g., growth surface region 118 as shown in FIG. 1C ) for promoting the ingrowth of tissue outside the eye. The periphery or shape of reservoir 105 can be defined at least in part by the placement of adhesive 200 disposed at the periphery between the two components 102 and 103. In some examples, second surface 108 can also include at least one low porosity region (e.g., low porosity region 120 as shown in FIG. 1C ) for inhibiting the ingrowth of tissue outside the eye.

[0111] For example, body portion 101 (e.g., body component 102 of body portion 101, and in some instances body component 103 as well) can comprise a biocompatible material such as expanded polytetrafluoroethylene (ePTFE). Additionally, the body components can be formed from other biocompatible materials, including biocompatible polymers that may or may not be microporous, including, but not limited to, polyurethane, silicone, polysulfone, polyvinylidene fluoride (PVDF), polyhexafluoropropylene (PHFP), perfluoroalkoxy polymer (PFA), polyolefin, fluorinated ethylene propylene (FEP), acrylic copolymers, expanded (expanded, expanded, stretched, or foamed) polyethylene (ePE), and polytetrafluoroethylene (PTFE).

[0112] At least the first body component 102 (and in some instances the second body component 103) can be in the form of one or more sheets or films, and the sheets or films can include knit, woven, and / or nonwoven forms containing individual fibers or multiple fiber strands. In some embodiments, at least the first body component 102 can be formed from multiple sheets or films of polymeric material. In some embodiments, the sheets or films can be laminated or otherwise mechanically joined to form the first body component 102 (and in some instances the second body component 103) of the body portion 101. Joining of the sheets or films can be achieved by various mechanisms, including heat treatment, high pressure compression, bonding agents such as one or more adhesives, lamination, or other suitable methods known to those skilled in the art.

[0113] In some embodiments, the body components 102 and 103 can be partially or fully bonded by thermal methods (e.g., by raising one or both of the polymers forming the materials above their melting point temperature). In some embodiments, such thermal methods promote the formation of adhesive or cohesive bonds between the materials or material layers. In some embodiments, the body components 102 and 103, and / or the material layers forming the first body component 102, can be partially bonded by thermal methods that raise at least one material above its melting point temperature. Such thermal methods can promote the formation of adhesive or cohesive bonds between the materials or material layers. In some embodiments, one or more suitable adhesives are utilized to provide a well-bonded interface. The body components 102 and 103 can be bonded to each other at one or more discrete locations (e.g., at the periphery) to form a stabilizing structure that extends throughout the resulting structure.

[0114] In some examples, the support structures, such as the tube or conduit 104, valve 300, and / or inner component 302, may be formed from materials including, but not limited to, PTFE, ePTFE, urethane, polyurethane, silicone (organopolysiloxane), polysulfone, PVDF, PHFP, PFA, polyolefin, FEP, ethylene fluorinated ethylene propylene (EFEP), ethylene tetrafluoroethylene (ETFE), and acrylic copolymers, among others. In some embodiments, the materials may include other biocompatible polymers suitable for use in forming the conduit 104, valve 300, and / or inner component 302, including, but not limited to, silicone-urethane copolymers, styrene / isobutylene copolymers, polyisobutylene, polyethylene-co-poly(vinyl acetate), polyester copolymers, nylon copolymers, fluorinated hydrocarbon polymers, and any copolymers or mixtures thereof. In various embodiments, the elastomer or elastomeric material can include perfluoromethyl vinyl ether and tetrafluoroethylene, (per)fluoroalkyl vinyl ether (PAVE), copolymers of tetrafluoroethylene and perfluoromethyl vinyl ether, silicone, fluoroelastomer, urethane, butyl rubber, styrene-butadiene, isobutylene-isoprene, or tetrafluoroethylene (TFE) / perfluoromethyl vinyl ether (PMVE) copolymer. In some examples, the valve 300 and / or internal component 302 can be formed using thermoplastic resins, including, but not limited to, acrylic and its copolymers, polyester and its copolymers, polypropylene, polystyrene, nylon and its copolymers, PTFE, among others.

[0115] Advantages of implementing drainage device embodiments as disclosed herein include, but are not limited to, overcoming the problems addressed above with respect to the prior art glaucoma treatment devices shown in Figures 7A-C, 8A-C, and 9A-C by providing sufficient tissue integration means in the plate body to reduce or eliminate the risk of fibrosis and reducing or preventing surrounding tissue from infiltrating the device's internal reservoirs to reduce or eliminate the risk of device failure or malfunction. For example, as shown in Figures 5A-C, the Ahmed® FP7 device can be modified by using a first body component 102 to form a reservoir 105, whereby a first surface 106 of the first body component 102 inhibits tissue ingrowth outside the eye. Also, for example, as shown in Figures 6A-C, the Baerveldt® BG 101-350 device can similarly be modified by using a first body component 102 to form a reservoir 105, with similar benefits.

[0116] Those skilled in the art will readily appreciate that the various aspects of the present disclosure may be implemented by any number of methods and apparatus configured to perform the intended functions. It should also be noted that the accompanying drawings referred to herein are not necessarily drawn to scale and may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawings should not be construed as limiting.

[0117] Various modifications and additions can be made to the exemplary embodiments described above without departing from the scope of the present disclosure. For example, while the embodiments described above refer to particular features, the scope of the present disclosure also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present disclosure is intended to embrace all such alternatives, modifications, and variations that fall within the scope of the claims, and all equivalents thereof.

Claims

1. A drainage device for draining fluid from an eye to tissue external to the eye, said drainage device being implantable at least partially within tissue of the eye; and a membrane having a first surface with a first porosity and a second surface with a second porosity greater than the first porosity, the second surface facing the first surface; and a plate having a porosity less than said first porosity; a body portion comprising: the membrane is more flexible than the plate; the membrane has a first thickness of about 25 μm to about 125 μm, the plate has a second thickness of about 0.8 mm to about 2.0 mm, and a body portion, the membrane and the plate defining a reservoir in the body portion; and a conduit fluidly coupled to the reservoir and having an end insertable into the eye to thereby facilitate drainage of fluid into the conduit; Including, A drainage device wherein a second surface of the membrane having a second porosity includes at least one ingrowth surface area for promoting ingrowth of tissue external to the eye.

2. The discharge device of claim 1 , wherein the plate is non-porous.

3. The discharge device of claim 1 or 2, wherein the plate comprises one or more of silicone or polypropylene.

4. 4. The drainage device of any one of claims 1 to 3, wherein the membrane comprises one or more of expanded polytetrafluoroethylene (ePTFE), expanded polyethylene (ePE), silicone, polysulfone, polyvinylidene fluoride (PVDF), polyhexafluoropropylene (PHFP), perfluoroalkoxy polymer (PFA), polyolefin, fluorinated ethylene propylene (FEP), or an acrylic copolymer.

5. The discharge device of any one of claims 1 to 4, further comprising an adhesive disposed between the membrane and the plate.

6. The discharge device of claim 5 , wherein the adhesive is a thermoplastic resin.

7. A drainage device for draining fluid from an eye to tissue external to the eye, said drainage device being implantable at least partially within tissue of the eye; and a membrane configured to allow fluid from the eye to pass therethrough and having a porosity configured to inhibit ingrowth of tissue external to the eye; and a plate having a porosity lower than the porosity of said membrane; a body portion including: the membrane is more flexible than the plate; the membrane has a first thickness of about 25 μm to about 125 μm, and the plate has a second thickness of about 0.8 mm to about 2.0 mm; the membrane and the plate define a reservoir in the body portion; and a conduit fluidly coupled to the reservoir and having an end insertable into the eye to thereby facilitate drainage of fluid into the conduit; a discharge device.

8. The discharge device of claim 7 , wherein the plate is non-porous.

9. 9. The discharge device of claim 7 or 8, wherein the plate comprises one or more of silicone or polypropylene.

10. 10. The drainage device of any one of claims 7 to 9, wherein the membrane comprises one or more of expanded polytetrafluoroethylene (ePTFE), expanded polyethylene (ePE), silicone, polysulfone, polyvinylidene fluoride (PVDF), polyhexafluoropropylene (PHFP), perfluoroalkoxy polymer (PFA), polyolefin, fluorinated ethylene propylene (FEP), or an acrylic copolymer.

11. The evacuation device of any one of claims 7 to 10, further comprising an adhesive disposed between the membrane and the plate.

12. The discharge device of claim 11 , wherein the adhesive is a thermoplastic resin.

13. A drainage device for draining fluid from an eye to tissue external to the eye, said drainage device being implantable at least partially within tissue of the eye; and a membrane having a first surface with a first porosity and a second surface with a second porosity greater than the first porosity, the second surface facing the first surface; and a plate having a porosity less than said first porosity; a body portion comprising: the membrane has a first thickness of about 25 μm to about 125 μm, and the plate has a second thickness of about 0.05 μm to about 10 μm; a body portion, the membrane and the plate defining a reservoir in the body portion; and a conduit at least partially defined by said membrane and said plate; Including, the conduit is fluidly coupled to the reservoir and is insertable into the eye to facilitate drainage of fluid into the conduit; A drainage device wherein the second surface of the first body component having the second porosity includes at least one ingrowth surface area for promoting ingrowth of tissue external to the eye.

14. The discharge device of claim 13 , wherein the plate is non-porous.

15. 15. The discharge device of claim 13 or 14, wherein the plate comprises one or more of silicone or polypropylene.

16. 16. The drainage device of any one of claims 13 to 15, wherein the membrane comprises one or more of expanded polytetrafluoroethylene (ePTFE), expanded polyethylene (ePE), silicone, polysulfone, polyvinylidene fluoride (PVDF), polyhexafluoropropylene (PHFP), perfluoroalkoxy polymer (PFA), polyolefin, fluorinated ethylene propylene (FEP), or an acrylic copolymer.

17. The discharge device of any one of claims 13 to 16, further comprising an adhesive disposed between the membrane and the plate.

18. 18. The discharge device of claim 17, wherein the adhesive is a thermoplastic resin.

19. A drainage device for draining fluid from an eye to tissue external to the eye, said drainage device being implantable at least partially within tissue of the eye; and a first body component having a first surface having a first porosity and a second surface having a second porosity greater than the first porosity, the second surface facing the first surface; and a second body component having a third porosity less than the first porosity; a collapsible body portion comprising: the first and second body components defining a reservoir of the collapsible body portion; and a conduit fluidly coupled to the reservoir and having an end insertable into the eye to thereby facilitate drainage of fluid into the conduit; Including, A drainage device wherein a second surface of the first body component having the second porosity includes at least one ingrowth surface area for promoting ingrowth of tissue external to the eye.

20. 20. The discharge device of claim 19, wherein the second body component is non-porous.

21. 21. The evacuation device of claim 19 or 20, wherein the second body component comprises one or more of silicone or polypropylene.

22. The ejection device of any one of claims 19 to 21, wherein the second body component has a higher stiffness than the first body component.

23. 23. The evacuation device of any one of claims 19 to 22, wherein the first body component comprises one or more of expanded polytetrafluoroethylene (ePTFE), expanded polyethylene (ePE), silicone, polysulfone, polyvinylidene fluoride (PVDF), polyhexafluoropropylene (PHFP), perfluoroalkoxy polymer (PFA), polyolefin, fluorinated ethylene propylene (FEP), or an acrylic copolymer.

24. The discharge device of any one of claims 19 to 23, further comprising an adhesive disposed between the first body component and the second body component.

25. 25. The discharge device of claim 24, wherein the adhesive is a thermoplastic resin.

26. A drainage device for draining fluid from an eye to tissue external to the eye, said drainage device being implantable at least partially within tissue of the eye; and a first body component having a first surface having a first porosity and a second surface having a second porosity greater than the first porosity, the second surface facing the first surface; and a second body component having a third porosity less than the first porosity and defining a reservoir of the body portion; a body portion comprising: a body portion, a first surface of the first body component attached to an outer surface of the second body component; and a conduit fluidly coupled to the reservoir and having an end insertable into the eye to thereby facilitate drainage of fluid into the conduit; Including, a second surface of the first body component having the second porosity including at least one ingrowth surface area for promoting ingrowth of tissue outside the eye, and a first surface of the first body component having the first porosity configured to inhibit ingrowth of tissue outside the eye.

27. 27. The discharge device of claim 26, wherein the second body component comprises a plurality of subcomponents joined together.

28. 28. The drainage device of claim 26 or 27, further comprising an open-ended valve surrounded by the body portion, fluidly coupled to the conduit, and partially defining the reservoir.

29. 29. The drainage device of any one of claims 26 to 28, wherein the first surface having the first porosity is configured to inhibit ingrowth of tissue external to the eye.

30. 30. The drainage device of any one of claims 26 to 29, wherein the second surface further comprises at least one region of low porosity for inhibiting ingrowth of tissue outside the eye.

31. The discharge device of any one of claims 26 to 30, wherein the first body component includes a plurality of interior regions having a porosity greater than the first porosity and less than the second porosity.

32. A drainage device according to any one of claims 26 to 31, wherein the conduit is attached to the periphery of the body portion.

33. A drainage device according to any one of claims 26 to 31, wherein the conduit is attached to the body portion over a portion of the cross-sectional length of the body portion.

Images