Biological fluid drainage device and method

Abstract

A drainage device for draining biological fluid from an eye to external ocular tissue is disclosed. The drainage device is at least partially implantable within ocular tissue. The drainage device includes an open, collapsible body portion having a first surface with a first porosity and a second surface with a second porosity greater than the first porosity, the second surface being opposite the first surface, and a conduit having a first end fluidly coupled to the first surface and a second end insertable into the eye, facilitating drainage of biological fluid into the conduit. The second surface with the second porosity includes at least one ingrowth surface area for promoting ingrowth of external ocular tissue.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Application No. 63 / 401,258, filed August 26, 2022, and U.S. Application No. 18 / 237,045, filed August 23, 2023, both of which are incorporated by reference in their entirety for all purposes.

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

[0003] background Various medical interventions involve draining excess biological fluid from one part of the body and redirecting it elsewhere in the body so it can be reabsorbed. In certain cases, this drainage is achieved through minimally invasive procedures such as endoscopic third ventriculostomy (ETV) and choroid plexus ablation (CPC). In other cases, 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, such as hydrocephalus and glaucoma.

[0004] If untreated, excess biological fluid can lead to an unhealthy buildup of pressure. 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, or intraocular, pressure. This elevated intraocular pressure is usually caused by an insufficient amount of aqueous humor being absorbed by the body. In some cases, aqueous humor is not absorbed quickly enough or at all, while in other cases, aqueous humor is additionally or alternatively produced too rapidly. Elevated intraocular pressure leads to gradual, sometimes permanent, loss of vision in the affected eye.

[0005] Attempts to treat glaucoma have included devices that are relatively bulky, inflexible, poorly adaptable, lack secure fixation to surrounding tissue, and experience relative device-to-tissue movement. Such movement can continually irritate surrounding tissue and potentially irritate the implant site. Irritation, in turn, can lead to increased chronic inflammatory tissue response, excessive scarring at the device site, and increased risk of device erosion due to conjunctivitis and endophthalmitis. Scar tissue effectively prevents aqueous humor reabsorption without erosion, interfering with device function. Summary of the Invention

[0006] Abstract Disclosed herein are devices for draining biological fluid from the eye to the tissue surrounding the eye, as well as methods for forming the devices that are at least partially implantable within the tissue of the eye, and methods for using the devices to treat glaucoma.

[0007] According to one example ("Example 1"), a drainage device for draining biological 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. The drainage device includes an open, collapsible body portion having a first surface with a first porosity and a second surface with a second porosity greater than the first porosity, the second surface opposite the first surface, and a conduit having a first end fluidly coupled to the first surface and a second end insertable into the eye, the conduit facilitating drainage of biological fluid into the conduit. The second surface with the second porosity includes at least one ingrowth surface area for promoting ingrowth of tissue external to the eye.

[0008] In addition to Example 1, according to another example ("Example 2"), the first surface having the first porosity is configured to inhibit ingrowth of tissue outside the eye.

[0009] In addition to Example 2, according to another example ("Example 3"), the second surface further comprises at least one low porosity region for inhibiting ingrowth of tissue outside the eye.

[0010] In addition to Example 3, according to another example ("Example 4"), the at least one low porosity region of the second surface defines a third surface opposite the first surface, the third surface being discontinuous from the second surface and having a third porosity lower than the second porosity.

[0011] In addition to Example 4, according to another example ("Example 5"), the third porosity is equal to the first porosity.

[0012] According to another example ("Example 6"), in addition to any one of the preceding examples, the body portion includes a plurality of interior regions having a porosity greater than the first porosity and less than the second porosity.

[0013] According to another example ("Example 7"), in addition to any one of the previous examples, the conduit is attached to a periphery of the body portion.

[0014] According to another example ("Example 8") in addition to any one of Examples 1-6, the conduit is attached to the body portion over at least 50% of the cross-sectional length of the body portion.

[0015] According to another example ("Example 9") in addition to any one of Examples 1-6, the conduit is attached to the first surface of the body portion at an attachment region, and the body portion further includes an erosion element having a trimmable portion extending outward from the attachment region relative to the conduit.

[0016] In addition to Example 9, according to another example ("Example 10"), the erodible element is a separate component from the body portion.

[0017] In addition to Example 9, according to another example ("Example 11"), the erodible element is a continuous extension of the body portion.

[0018] According to another example ("Example 12"), in addition to any one of the previous examples, the body portion includes an inner component having a first surface with a first surface porosity and a second surface with a second surface porosity greater than the first surface porosity, and an outer component having a first surface with a first surface porosity and a second surface with a second surface porosity greater than the first surface porosity, the inner component and the outer component being arranged such that the first surface of the inner component faces the first surface of the outer component.

[0019] In addition to Example 12, according to another example ("Example 13"), the conduit is disposed between the first surface of the inner component and the first surface of the outer component.

[0020] According to another example ("Example 14") in addition to Examples 12 or 13, the device further includes one or more additional inner components, each having a first surface with a first surface porosity and a second surface with a second surface porosity greater than the first surface porosity, and the additional inner components are attached to the outer component such that each of the first surfaces of the additional inner components faces the first surface of the outer component.

[0021] In addition to any one of the previous examples, according to another example ("Example 15"), the device further includes a support structure attached to at least a portion of the body portion.

[0022] In addition to Example 15, according to another example ("Example 16"), the conduit is attached to a portion of the support structure.

[0023] In addition to Examples 15 or 16, according to another example ("Example 17"), the support structure includes one or more thermoplastic components.

[0024] In addition to Example 17, according to another example ("Example 18"), one or more channels are formed between two of the thermoplastic components, and are configured to allow biological fluids to pass through the channels.

[0025] In addition to Example 12, and in addition to any of Examples 15 to 18, according to another example ("Example 19"), the support structure is disposed between the first surface of the inner component and the first surface of the outer component.

[0026] The foregoing examples are merely illustrative and should not be construed as limiting or narrowing the scope of any of the inventive concepts otherwise provided by this disclosure. While multiple examples 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 as restrictive. [Brief explanation of the drawings]

[0027] BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings are included to provide a further understanding of embodiments of the present disclosure, and are incorporated in and constitute a part of this specification, illustrating examples and, together with the description, serving to explain the principles of the present disclosure.

[0028] [Figure 1A] FIG. 1A is a schematic illustration of a cross-sectional view of a drainage device according to an embodiment disclosed herein.

[0029] [Figure 1B] FIG. 1B is an SEM image of a portion of a cross-section of a drainage device according to an embodiment disclosed herein (image is to the scale indicated in the image).

[0030] [Figure 1C] FIG. 1C is a schematic illustration of a cross-sectional view of an eye when a drainage device according to an embodiment disclosed herein is at least partially implanted.

[0031] [Figure 1D] FIG. 1D is a microscopic image of a tissue slide stained with a tissue stain showing a cross section of a drainage device according to an embodiment disclosed herein (image is to scale as indicated in the image).

[0032] [Figure 1E] FIG. 1E is a schematic illustration of a partial view of a multilumen fluid conduit according to an embodiment disclosed herein.

[0033] [Figure 2A] FIG. 2A is a schematic illustration of a bottom view of a drainage device according to an embodiment disclosed herein. [Figure 2B] FIG. 2B is a schematic illustration of a bottom view of a drainage device according to an embodiment disclosed herein.

[0034] [Figure 3] FIG. 3 is a schematic illustration of a cross-sectional view of a drainage device according to an embodiment disclosed herein.

[0035] [Figure 4] FIG. 4 is a schematic illustration of a perspective view of a drainage device according to an embodiment disclosed herein. [Figure 5] FIG. 5 is a schematic illustration of a perspective view of a drainage device according to an embodiment disclosed herein. [Figure 6] FIG. 6 is a schematic illustration of a perspective view of a drainage device according to an embodiment disclosed herein.

[0036] [Figure 7A] FIG. 7A is a schematic illustration of a bottom view of a drainage device according to an embodiment disclosed herein.

[0037] [Figure 7B] FIG. 7B is a schematic diagram of a top view of the drainage device of FIG. 7A.

[0038] [Figure 7C] FIG. 7C is a schematic diagram of a cross-sectional view of the drainage device of FIG. 7B taken along line CC.

[0039] [Figure 8A] FIG. 8A is a schematic illustration of a bottom view of a drainage device according to an embodiment disclosed herein.

[0040] [Figure 8B] FIG. 8B is a schematic illustration of a top view of the drainage device of FIG. 8A.

[0041] [Figure 8C] FIG. 8C is a schematic diagram of a cross-sectional view of the drainage device of FIG. 8B taken along line CC.

[0042] [Figure 9A] FIG. 9A is a schematic illustration of a bottom view of a drainage device according to an embodiment disclosed herein.

[0043] [Figure 9B] FIG. 9B is a schematic diagram of a top view of the drainage device of FIG. 9A.

[0044] [Figure 9C] FIG. 9C is a schematic diagram of a cross-sectional view of the drainage device of FIG. 9B taken along line CC.

[0045] [Figure 10A] FIG. 10A is a schematic illustration of a bottom view of a drainage device according to an embodiment disclosed herein.

[0046] [Figure 10B] FIG. 10B is a schematic illustration of a top view of the drainage device of FIG. 10A.

[0047] [Figure 10C]FIG. 10C is a schematic diagram of a cross-sectional view of the drainage device of FIG. 10B taken along line CC.

[0048] [Figure 11A] FIG. 11A is a schematic illustration of a bottom view of a drainage device according to an embodiment disclosed herein.

[0049] [Figure 11B] FIG. 11B is a schematic diagram of a top view of the drainage device of FIG. 11A.

[0050] [Figure 11C] FIG. 11C is a schematic diagram of a cross-sectional view of the drainage device of FIG. 11B taken along line CC.

[0051] [Figure 11D] FIG. 11D is a schematic illustration of a bottom view of the drainage device of FIG. 11A with two different attachment positions according to embodiments disclosed herein. [Figure 11E] FIG. 11E is a schematic illustration of a bottom view of the drainage device of FIG. 11A with two different attachment positions according to embodiments disclosed herein.

[0052] [Figure 11F] FIG. 11F is a photograph of a top view of a drainage device according to an embodiment disclosed herein.

[0053] [Figure 11G] FIG. 11G is a photograph of a bottom view of the drainage device of FIG. 11F.

[0054] [Figure 12A] FIG. 12A is a schematic illustration of a bottom view of a drainage device according to an embodiment disclosed herein.

[0055] [Figure 12B] FIG. 12B is a schematic diagram of a top view of the drainage device of FIG. 12A.

[0056] [Figure 12C] FIG. 12C is a schematic illustration of a cross-sectional view of the drainage device of FIG. 12B taken along line CC.

[0057] [Figure 13A] FIG. 13A is a schematic illustration of a bottom view of a drainage device according to an embodiment disclosed herein.

[0058] [Figure 13B] FIG. 13B is a schematic illustration of a top view of the drainage device of FIG. 13A.

[0059] [Figure 13C] FIG. 13C is a schematic illustration of a cross-sectional view of the drainage device of FIG. 13B taken along line CC.

[0060] [Figure 14A] FIG. 14A is a schematic illustration of a bottom view of a drainage device according to an embodiment disclosed herein.

[0061] [Figure 14B] FIG. 14B is a schematic illustration of a top view of the drainage device of FIG. 14A.

[0062] [Figure 14C] FIG. 14C is a schematic illustration of a cross-sectional view of the drainage device of FIG. 14B taken along line CC.

[0063] [Figure 15A] FIG. 15A (Prior Art) is a photograph of the top view of an Ahmed glaucoma valve modified with a polyethylene shell and implementing a solid plate as known in the art.

[0064] [Figure 15B] FIG. 15B (Prior Art) is a photograph of a side view of the prior art glaucoma valve of FIG. 15A with a portion of the solid plate removed to reveal the reservoir therein.

[0065] [Figure 15C] FIG. 15C (Prior Art) is an SEM image of a portion of the surface of a solid plate used in the prior art glaucoma valve of FIG. 15A (image is to the scale shown in the image).

[0066] 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 disclosure or that obscure other details may have been omitted. It should, of course, be understood that the disclosure is not necessarily limited to the specific examples or embodiments shown or depicted herein. DETAILED DESCRIPTION OF THE INVENTION

[0067] Detailed Description Definitions and Terminology The present disclosure is not to be construed in a limiting sense. 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 give such terms.

[0068] With respect to the term imprecision, the terms "about" and "approximately" may be used interchangeably to refer to a measurement, 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, as understood and easily ascertained by one of ordinary skill in the relevant art. Such deviations may result, for example, from measurement error, differences in calibration of measuring and / or manufacturing equipment, human error in reading and / or setting measurements, small adjustments made to optimize performance and / or structural parameters to account for differences 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 such a reasonably small difference would not be easily ascertainable 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.

[0069] 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 in combination, A and C in combination, B and C in combination, or A, B, and C in combination. Each of A, B, and C in the above expressions can be an element such as X, Y, or Z, or a combination of X1-X. n , Y1-Y m , Z1-Z o When referring to a class of elements such as X, Y, and Z, the phrase includes 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

[0070] Every maximum numerical limitation given throughout this disclosure shall be deemed to include, in the alternative, every lower numerical limitation, as if such lower numerical limitations were all expressly written herein. Every minimum numerical limitation given throughout this disclosure shall be deemed to include, in the alternative, every higher numerical limitation, as if such higher numerical limitations were all expressly written herein. Every numerical range given throughout this disclosure shall be deemed to include, in the alternative, every narrower numerical range that falls within such broader numerical range, as if such narrower numerical ranges were all expressly written herein.

[0071] Before describing 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. The use of "including," "comprising," "having," and variations thereof herein is intended to encompass the items listed thereafter and equivalents thereof, as well as additional items.

[0072] As used herein, the term "fibril" describes 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 fiber piece whose width (or thickness) is much shorter or smaller than its length.

[0073] As used herein, the term "node" describes a connection point of at least two fibrils, where a connection can be defined as a location where two fibrils contact each other, either permanently or temporarily. In some instances, a node is also used to describe a larger volume of polymer than a fibril, where a fibril begins or ends without a clear continuation of the same fibril through the node. In some instances, a node will be wider and shorter than a fibril.

[0074] As used herein, "node" and "fibril" may, but need not, be used to describe objects that are typically connected or interconnected, e.g., of microscopic size. 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 of the object are invisible to the naked eye or are difficult, if not impossible, to observe without the aid of a microscope (such as, but not limited to, a scanning electron microscope or SEM) or any suitable type of magnifying device.

[0075] Description of Various Embodiments Various embodiments are directed to drainage devices that can be implanted in the eye to drain such fluids from the AC of the eye and accommodate measures to avoid or prevent intraocular hypotony. However, many prior art drainage devices merely define a lumen for redirecting fluid from the AC to another location where the pressure is lower than the AC, and therefore do not include components that redirect fluid flow after the fluid leaves the AC. That is, in contrast to various embodiments described herein, such drainage devices do not include components that contain the fluid when it reaches a location where the pressure is lower than the AC.

[0076] Furthermore, in contrast to some embodiments described herein, some conventional drainage devices only provide an initial flow restriction during the drainage device implantation procedure. For example, devices using dissolvable plug sections provide an initial outflow resistance to avoid early postoperative IOP reduction and hypotony, and then increase flow over time by lowering outflow resistance to compensate for increased biological outflow resistance after surgery is completed, but do not provide a long-term means of avoiding or preventing hypotony within the eye.

[0077] Other conventional drainage devices, such as those made of silicone, can incorporate solid plates to receive fluid from the AC of the eye and store it in an internal chamber formed between the plates, as shown in Figures 15A-15C. The device shown in Figures 15A and 15B is the Ahmed Glaucoma Value Model M4 (New World Medical, Inc., Rancho Cucamonga, CA), which features a polyethylene shell and reduces the fibrotic response around the drainage plate in glaucoma patients compared to the S2 and FP7 models. This is as previously published in Kim J, Allingham RR, Hall J, et al., "Clinical Experience with a New Glaucoma Drainage Implant," Journal of Glaucoma, February 2014, 23(2):e91-7. DOI: 10.1097 / ijg.0b013e3182955d73. PMID: 23689073. Prior art devices are made from a tube (T) placed between two layers (L1 and L2) of solid material, such as a porous polyethylene shell (e.g., Medpor) that conforms to the curvature of the eye, defining a reservoir (R) between layers L1 and L2 through which the tube T directs fluid from the eye. As shown in FIG. 15C (scaled so that the black bar at the bottom of the figure represents 500 μm), the surfaces of layers L1 and L2 contain pores for improved tissue integration, allowing adjacent tissue to integrate into the polyethylene shell surrounding the drainage device as well as allowing fluid stored within reservoir R to be released into the surrounding environment, preventing the shell from placing undue stress on the surrounding tissue.

[0078] However, in contrast to the various embodiments described herein, implanting a solid or rigid piece of material (i.e., a material that is not flexible and thin) inside the eye, such as that shown in FIGS. 15A-15C, can increase stress on the eye when subjected to pressure from the AC, particularly within the conjunctival tissue of the eye, causing discomfort as well as other complications that may arise from long-term elevated pressure within such sensitive areas of the eye.

[0079] Those skilled in the art will readily appreciate that the various aspects of the present disclosure can 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 (unless otherwise noted) and may be exaggerated to illustrate various aspects of the present disclosure, and in that regard, the drawings should not be construed as limiting.

[0080] Various aspects of the present disclosure relate to devices and methods for draining biological fluids. For example, the present disclosure addresses devices and methods for draining aqueous humor from the anterior chamber (AC) (FIG. 1C) of a patient's eye so that the aqueous humor can be reabsorbed elsewhere in the body. FIG. 1C illustrates an eye with a 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 aspect of the present disclosure, a mechanism is provided for reabsorbing aqueous humor drained from the AC of the eye to reduce or otherwise stabilize intraocular pressure. However, those skilled in the art will appreciate that aspects of the present disclosure are also useful for other applications where drainage of biological fluids for redirection within the body is desired. In some instances, the target implantation location can include a subconjunctival and / or sub-Tenon location of the eye. In some instances, device 100 is 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.

[0081] Different embodiments and examples of drainage devices 100 for treating glaucoma are disclosed herein. For example, FIG. 1A illustrates an example of the device 100. As illustrated, the device 100 is an implantable device that can be used to drain biological fluid from the eye when at least partially implanted within ocular tissue. In some examples, the fluid can drain to tissue surrounding the eye or to tissue external to the eye. The device 100 includes an open, collapsible body portion 102 and a fluid conduit 104. The body portion 102 has a first surface 106 having a first porosity and a second surface 108 having a second porosity greater than the first porosity. The second surface 108 is opposite the first surface 106 (or is located at a position on the body portion 102 opposite the position of the first surface 106). The body portion 102 is "open." This is because there is no internal enclosed space or chamber, and therefore no chamber or "reservoir" as shown in the prior art device of Figure 15B.

[0082] In some examples, the thickness of the main body portion 102 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 suitable value or range therebetween, and / or combinations of ranges therebetween. In some examples, body portion 102 can have a diameter ranging from 5 mm to 15 mm, e.g., 10 mm. In some embodiments, body portion 102 can be elliptical and can include a major dimension (e.g., along the major axis of the ellipse) of up to about 30 mm and a corresponding minor dimension (e.g., along the minor axis of the ellipse) of up to about 10 mm. As noted above, due to variations in human anatomy, body portion 102 can exceed such dimensions (e.g., 10 mm, 15 mm, and 30 mm) without substantially interfering with normal ocular function (e.g., turning and blinking) or substantially reducing the flexibility of the aqueous humor diffusion member, which can result in undesirable relative movement between drainage device 100 and surrounding tissue during implantation, potentially resulting in tissue irritation, foreign body tissue reaction, and / or excessive scarring. Similarly, the body portion 102 can have a diameter of less than 5 mm, less than 3 mm, or less than 3 mm, so long as it is operable to adequately contain the drained aqueous humor and promote reabsorption of the aqueous humor to provide effective treatment for the patient.

[0083] The conduit 104 has a first end 110 and a second end 112. The conduit 104 can be a tube or any suitable structure through which a fluid can pass. The first end 110 is fluidly coupled to the first surface 106, and the second end 112 is insertable into a patient's eye, thereby facilitating the drainage of biological 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, as shown in FIG. 1A , fluid may enter the lumen 114 of the conduit 104 via the second end 112, pass through the lumen 114, and then exit via the first end 110. The fluid may then flow away from or towards the body portion 102, such that the fluid enters the body portion 102 from the first surface 106, passes through the material of the body portion 102, and exits the body portion 102 from the second surface 108. The second surface 108 having the second porosity also includes at least one ingrowth surface region 118 that promotes tissue ingrowth, as shown in FIG. 1B.

[0084] FIG. 1B shows a microscopic view of the microporous material on the exterior (second surface 108) of the body portion 102 of the device 100, according to some embodiments. The body portion 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. 1B is labeled "5.00 kV 4.2 mm x500 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. 1B may be referenced throughout with respect to a medical implant device or system. As one skilled in the art can appreciate with reference to FIG. 1B, the microporous aspects and parameters of a microporous material may be defined in a variety of ways. In applications of microporous materials in ophthalmic devices such as device 100 described herein, the microporous material is configured to be placed in situ within the tissue of the eye to facilitate drainage of biological fluid from the eye (as indicated by the white arrows labeled "Fluid Flow" representing the direction of flow of biological fluid relative to the first surface 106 and the second surface 108). The microporous properties of such microporous materials may generally be characterized by a volumetric porosity value, which may be defined as the ratio of the volume of air or fluid defined by and contained within the microporous material to the total volume (or total volume) of the microporous material.

[0085] 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 of which the chamber for holding air or fluid is 30 mm 3 A microporous material occupying a volume of 0.3 would have a volumetric porosity value of 0.3 because 30% of the volume of the microporous material is empty, or temporary space filled with air or other fluid.

[0086] As can 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 volume of the two materials is the same, then both microporous materials can have the same volumetric porosity.

[0087] As can be further appreciated, the properties of microporous materials used in ophthalmic drainage devices can be defined by the size of the passageways through the microporous material, or similarly, the pore size measured where the passageways terminate at the surface of the microporous material or measured along the length of the passageways 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.

[0088] 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 flow path due to the frequency of the passage tortuosity or the placement of obstacles within the fluid flow path. The air / fluid passage rate through a microporous material can be managed by controlling or defining any of the above properties of the material, providing a material suitable for use in facilitating the drainage of biological fluids from the eye.

[0089] For simplicity, the aforementioned properties and variables of the microporous materials used in the various embodiments and examples described herein can be expressed simply as volumetric porosity, pore or passage size, or porosity, which can be based on a tortuosity metric. Referring again to FIG. 1B, the interior portion of the microporous material can have a variety of porosities (or volumetric porosity or pore size or tortuosity). The interior portion can extend between an interior surface (first surface 106) and an exterior surface (second surface 108).

[0090] In any of these portions of body portion 102, the porosity can comparatively range from small pore size (SP), small-medium pore size (MSP), medium pore size (MP), medium-large pore size (MLP), and large pore size (LP). For purposes of this discussion, assuming delivery travels along a relatively straight path through the microporous material, sequentially engaging the pores of inner surface 106, the uniform interior portion, and outer surface 108, the composite flow resistance can similarly be represented by the interconnections of each pore. For example, inner surface 106 typically has low porosity throughout (e.g., to resist tissue ingrowth through body portion 102 and / or to maintain a plane between device 100 and the sclera), while the interior portion and portions of outer surface 108 can have any of the aforementioned porosities. Under these circumstances, when the interior portion has a moderate porosity, e.g., when the interior portion has a moderate porosity and the exterior surface 108 has a high porosity, the drainage of biological fluid from the eye through the microporous material to the tissue surrounding the device can be expressed as SP-MP-LP. More examples are described below.

[0091] Various delivery pathways 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, other flow paths can be nonlinear. For example, under certain conditions, at least a portion of the flow can continue 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 a relatively uniform layer across the microstructure interior, or, as shown here, can have variable portions throughout the thickness of the microporous material.

[0092] In some examples, the body portion 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 body portion 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.

[0093] 1B , the fluid pathway can also be affected by a pressure difference between a fluid in one region (e.g., first surface 106) and a fluid in another region (e.g., second surface 108). In some instances, first surface 106 has a first porosity that prevents or inhibits tissue ingrowth. In some instances, 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, for example, labeled SPs and / or MSPs.

[0094] 1C shows an exemplary location where device 100 may be implanted in the eye. In the illustrated example, device 100 is sized and shaped to be implantable within a dissected subconjunctival space, such as between the sclera and conjunctiva of a patient's eye.

[0095] As described above, in various embodiments, the fluid conduit is a soft, malleable tubular member insertable 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 implantation procedure. Soft, thin, malleable tubular structures are generally difficult to advance through tissue. Therefore, in various embodiments, the glaucoma drainage devices described herein can further include a reinforcing member, such as a support structure, integrated with the device. The reinforcing member can form a placement assembly with column strength that exceeds the column strength of the fluid conduit. A treatment method can include advancing a body portion of the device to an implantation location using the reinforcing member.

[0096] In some instances, as will be appreciated by those skilled in the art, device 100 can be implanted internally (e.g., from within the eye), such as through a clear incision in the cornea, and placed in the subconjunctival space through an incision made through the sclera. In other embodiments, device 100 can be implanted externally (e.g., from outside the eye), such as through a conjunctival incision, as will be appreciated by those skilled in the art. In some embodiments, a radial incision in the conjunctiva, typically near the limbal junction, can be made, and blunt dissection of the conjunctiva can be performed to expose the sclera and provide a site for placement of the aqueous diffusion element. In some embodiments, this requires suturing the aqueous diffusion element to the sclera. In some embodiments, a small needle, typically a 22-gauge or 23-gauge needle, can be inserted near the scleral spur to provide a pathway for subsequent insertion and placement of a fluid conduit into the AC. Similarly, it will be appreciated that the various fluid conduit modifications described above can be performed via one or more of an ab-internal clear-corneal approach and an ab-external approach.

[0097] 1D is an exemplary image of a histopathology slide showing the open collapsible body portion 102 and how ocular conjunctival tissue interacts or engages with the body portion 102. In the 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), thereby staining collagen blue and tissue cells red. The body portion 102 includes a first surface 106 and a second surface 108, where the second surface 108 includes 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 and promote the ingrowth of the tissue cells 122 into portions of the second surface 108, while the low-porosity regions 120 prevent or otherwise substantially inhibit such ingrowth. Because the first surface 106 does not contain or has any tissue cells or collagen, the first surface 106 prevents or inhibits the ingrowth of tissue cells 122 from outside the eye, while the second surface 108 may at least partially promote the ingrowth of tissue cells and collagen.

[0098] Additionally or alternatively, in various embodiments, the fluid conduit 104 of the various glaucoma drainage devices described herein can be configured to include multiple lumens 114. Figure 1E shows such an example of a conduit 104 having four lumens 114A, 114B, 114C, and 114D through which fluid enters the conduit 104 (via the second end 112) and exits the conduit 104 (via the first end 110). In some embodiments, one or more of the lumens of the multi-lumen fluid conduit 104 can be initially blocked, and one or more of the lumens 114 (e.g., 114A-114D) of the multi-lumen fluid conduit 104 can be post-operatively unblocked to increase the fluid flow rate through the fluid conduit 104. Thus, in various embodiments, the various glaucoma drainage devices described herein can include one or more mechanisms that can be modified post-operatively to increase and / or decrease the aqueous humor transmission rate per unit time through the glaucoma drainage device. Thus, the glaucoma drainage devices described herein are operable to dynamically change to accommodate changes in the anatomy or function of a patient's eye post-operatively, avoiding the need for additional invasive surgery.

[0099] 2A and 2B each show an example of a drainage device 100 including a support structure 200 attached to at least a portion of the body portion 102. The support structure 200 is disposed on the first surface 106 around the periphery of the body portion 102. In some examples, the support structure 200 can cover at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, or any other suitable range, combination of ranges, or value therebetween. In some examples, the support structure 200 can be a solid material, a solid and microporous material, a solid material with a microporous membrane attached, or can be made from multiple components that are not directly attached to each other, as appropriate and described further herein.

[0100] For example, in Figure 2A, support structure 200 covers all (or nearly all) of the periphery, providing a more uniform stiffening effect to body portion 102 of the device, while in Figure 2B, a portion of the periphery on top of first surface 106 is left exposed, providing a different stiffening effect to body portion 102, with one end of body portion 102 being stiffer than the opposite end and with the stiffness gradually varying (i.e., decreasing or increasing) from one end to the other, as shown. In some examples, conduit 104 is attached to support structure 200. In some examples, support structure 200 can be made from any suitable biocompatible material that has a higher stiffness or stiffness than body portion 102 of device 100.

[0101] FIG. 3 illustrates an example of a drainage device 100 in which the body portion 102 includes an inner component 300 and an outer component 302. The inner and outer components can be two membrane layers bonded, integrated, fused, and / or attached using any suitable means. The term "inner" is used in reference to the eye in which the drainage device 100 may be implanted, with the "inner" component being proximal to the eye and the "outer" component being distal to the eye relative to the inner component. As shown, the inner component 300 has a first surface 106A having a first surface porosity and a second surface 108A having a second surface porosity greater than the first surface porosity. The outer component 302 similarly has a first surface 106B and a second surface 108B. The first surface 106B has a first surface porosity, and the second surface 108A has a second surface porosity greater than the first surface porosity. In some examples, the inner component 300 and the outer component 302 can be positioned such that the first surface 106A of the inner component 300 faces the first surface 106B of the outer component 302.

[0102] In the illustrated example, the conduit 104 may be disposed between a first surface 106A of the inner component 300 and a first surface 106B of the outer component 302. The support structure 200 may be disposed between the inner component 300 and the outer component 302. The first surfaces 106A and 106B may have similar surface porosities, and the second surfaces 108A and 108B may have similar surface porosities.

[0103] For example, body portion 102 (or, in some examples, one or more of inner and outer components 300, 302 of body portion 102) can include a biocompatible material such as expanded polytetrafluoroethylene (ePTFE). Additionally, one or more of inner and outer components 300, 302 can be formed from other biocompatible materials, including biocompatible polymers, which 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 polyethylene (ePE), and polytetrafluoroethylene (PTFE).

[0104] The inner component 300 and / or the outer component 302 can be in the form of one or more sheets or films, including knit, woven, and / or nonwoven fabrics containing individual fibers or multiple fiber strands. In some embodiments, the inner component 300 and / or the outer component 302 can be formed from multiple sheets or films of polymeric material. In some embodiments, the sheets or films can be laminated or mechanically bonded to form the inner component 300 and / or the outer component 302, as well as to form the body portion 102. Bonding of the sheets or films can be achieved by various mechanisms, including heat treatment, high pressure compression, one or more bonding agents such as adhesives, lamination, or other suitable methods known to those skilled in the art.

[0105] In some embodiments, adjacently positioned inner and outer components 300, 302, and / or layers of material forming such inner and outer components 300, 302, can be partially or completely bonded by thermal methods (e.g., by raising one or both of the polymers forming the materials above their melting points). In some embodiments, such thermal methods promote the formation of adhesive or cohesive bonds between the materials or layers of materials. In some embodiments, adjacently positioned inner and outer components 300, 302, and / or layers of material forming such inner and outer components 300, 302, can be partially bonded by thermal methods in which at least one material is heated above its melting point. Such thermal methods can promote the formation of adhesive or cohesive bonds between the materials or layers of materials. In some embodiments, one or more suitable adhesives are used to provide a well-bonded interface. Adjacently positioned inner and outer components 300, 302, and / or layers of material forming such inner and outer components 300, 302, can be bonded at one or more discrete locations (e.g., peripheral edges 700) to form a stabilizing structure that extends throughout the resulting structure.

[0106] In some examples, the tube or conduit 104 and / or support structure 200 may be formed from one or more 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 material may include other biocompatible polymers suitable for use in forming the conduit 104 and / or support structure 200, 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 copolymers or mixtures of any of the foregoing. 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 support structure 200 can be formed using thermoplastics, including, but not limited to, acrylic and its copolymers, polyester and its copolymers, polypropylene, polystyrene, nylon and its copolymers, PTFE, etc., among others.

[0107] FIG. 4 illustrates an example of a device 100 in which the inner component 300 and the support structure 200 at least partially overlap. The inner component 300 may be shaped like a washer or flat ring, with the center of the inner component 300 forming an opening through which fluid can escape after exiting the conduit 104. Similarly, the support structure 200 resembles such a washer, but also has an opening around its periphery, allowing the conduit 104 to be inserted as shown, thereby positioning and securing the conduit 104 in a position surrounded by the support structure 200, the inner component 300, and the outer component 302. The second surface 108A of the inner component 300 and the first surface 106B of the outer component 302 face in the same direction as shown. The support structure 200 can be welded or joined by heat treating or sintering portions of the inner component 300 and the outer component 302.

[0108] FIG. 5 illustrates an example of device 100 implemented with multiple support structure components 200A, 200B, and 200C. While three support structure components are shown, there can be four or more components, or there can be two components (as shown in FIG. 6). In some examples, there can be two support structure components. In the example shown, conduit 104 is disposed between support structure components 200B and 200C, and support structure component 200A can be disposed such that one or more channels 500 are formed between support structure component 200A and the other support structure components 200B and 200C. In some examples, a support structure component is disposed between first surface 106A of inner component 300 and first surface 106B of outer component 302, for example, to attach first surface 106A to first surface 106B.

[0109] In some examples, fluid may exit through channels 500, which may be defined by support structure components 200A, 200B, and 200C and inner and outer components 300, 302 of body portion 102. In some examples, support structure components 200A, 200B, or 200C may have a shape resembling an arch, a semicircle, a quarter circle, or any other suitable configuration, depending on the number of support structure components present. In some examples, where there are multiple smaller support structure components (e.g., 10 support structure components), each support structure component may be shaped like a square or rectangle and positioned around the periphery of body portion 102, thereby forming multiple channels therebetween. In some examples, each component of support structure 200 may be made from a thermoplastic material.

[0110] Figure 6 shows an example of device 100 in which support structure 200 has two support structure components 200A and 200B, with conduit 104 attached to component 200B. In this example, body portion 102 is a single component, so there are no inner and outer components as shown in Figure 5. Instead, channel 500 is defined by body portion 102 (or more specifically, first surface 106 of body portion 102) and support structure components 200A and 200B.

[0111] 7A-7C show an example of device 100 in which conduit 104 is attached to a periphery 700 of first surface 106 of body portion 102 using an adhesive 704 between conduit 104 and body portion 102. Any suitable adhesive may be used, including, but not limited to, a heat-activated adhesive.

[0112] 8A-8C show examples of device 100 in which conduit 104 is attached to first surface 106 of body portion 102 using adhesive 704 that extends across at least 50% of the cross-sectional length of body portion 102. In some examples, conduit 104 can be attached to body portion 102 across at least 50%, at least 60%, at least 70%, at least 80%, or any other suitable range, combination of ranges, or value therebetween.

[0113] 9A-9C show an example of device 100 in which conduit 104 is attached to a periphery 700 of first surface 106 of body portion 102 using adhesive 704 between conduit 104 and body portion 102, and erodible element 702 extends outward from periphery 700 of body portion 102 relative to the location of adhesive 704. erodible element 702 is not attached to conduit 104 and is free to move relative to conduit 104.

[0114] 10A-10C show examples of device 100 in which erodible element 702 extends outward from periphery 700 of body portion 102 relative to the location of adhesive 704, and conduit 104 is attached to first surface 106 of body portion 102 using adhesive 704 that extends over at least 50% of the cross-sectional length of body portion 102. In some examples, conduit 104 can be attached to body portion 102 over at least 50%, at least 60%, at least 70%, at least 80%, or any other suitable range, combination of ranges, or value therebetween. The erodible element 702 is not attached to conduit 104. In some examples, erodible element 702 can be a separate component from body portion 102, and erodible element 702 can be temporarily or permanently secured, connected, or adhered to body portion 102. In some examples, erodible element 702 can be a continuous extension of body portion 102.

[0115] 11A-11G show examples of device 100 in which support structure 200 is disposed between inner component 300 and outer component 302 of body portion 102. Adhesive 704 is disposed in attachment regions 1100, which can extend the length along the periphery 700 of body portion 102 (as shown in FIG. 11D) or along a portion of erodible element 702 (as shown in FIGS. 11E and 11G). In some examples, attachment regions 1100 can extend in both directions, i.e., along the periphery 700 and along a portion of erodible element 702.

[0116] When attachment region 1100 extends along a portion of eroding element 702, eroding element 702 is separated into two portions, first eroding element portion 702A and second eroding element portion 702B, located on either side of attachment region 1100. Thus, while eroding element 702 is partially attached to conduit 104, first portion 702A and second portion 702B of eroding element 702 are not attached to conduit 104. Thus, these portions 702A and 702B are freely movable relative to conduit 104.

[0117] 12A-12C show an example of a device 100 in which, in addition to a body portion 102 having an inner component 300 and an outer component 302, the body portion 102 also includes one or more additional inner components 1200, each having a first surface 106C with a first surface porosity and a second surface 108C with a second surface porosity that is greater than the first surface porosity. The additional inner components 1200 are attached to the outer component 302 such that each of the first surfaces 106C of the additional inner components 1200 faces the first surface 106B of the outer component 302. Thus, the second surface 108B of the outer component 302 and the second surface 108C of the additional inner components 1200 face away from each other.

[0118] In some examples, there may be only one additional inner component. In some examples, there may be two or more additional inner components. In the illustrated example, device 100 includes two additional inner components 1200A and 1200B, and support structural components 200A, 200B, and 200C are arranged such that support structural component 200A is positioned between inner component 300 and outer component 302 of body portion 102, support structural component 200B is positioned between additional inner component 1200A and outer component 302 of body portion 102, and support structural component 200C is positioned between additional inner component 1200B and outer component 302 of body portion 102. As shown, support structural components 200B and 200C can be used to attach first surfaces 106C of additional inner components 1200A and 1200B, respectively, to first surface 106B of outer component 302 of body portion 102. In some examples, each of the support structural components 200A, 200B, and 200C can be made from a thermoplastic material.

[0119] 13A-13C show examples of device 100 in which a portion of inner component 300 of body portion 102 covers a portion of conduit 104, such that conduit 104 is at least partially disposed between inner component 300 and outer component 302. In some examples, adhesive 704 is applied to both sides of conduit 104 to attach conduit 104 to both inner component 300 and outer component 302. In some examples, a portion of inner component 300 can be attached to a portion of erodible element 702 extending from outer component 302. The applied adhesive 704 can be multiple separate pieces of adhesive material, or adhesive 704 can be a single piece of adhesive material that at least partially surrounds the outer surface of conduit 104.

[0120] In various embodiments, erodible element 702 is an element, feature, component, or portion of device 100 that covers a portion of conduit 104 to minimize erosion of one or more tissues of the eye by conduit 104 when device 100 is implanted. In various examples, device 100 is implantable within a pocket formed between the conjunctiva and sclera of the eye, as will be understood by those skilled in the art.

[0121] In some instances, for example, erosion element 702 extends from the body of device 100 over conduit 104. The erosion element 702 acts as a protective barrier between conduit 104 and one or more surrounding tissues of the eye. For example, device 100 can be configured such that, when implanted, erosion element 702 extends along conduit 104 between conduit 104 and the conjunctiva of the eye. In some such embodiments, erosion element 702 helps minimize or even prevent erosion of conduit 104 through the conjunctiva by forming a barrier between conduit 104 and the conjunctiva when device 100 is implanted in the eye.

[0122] In some embodiments, erodible element 702 forms an integral, inseparable element, feature, component, or portion of device 100. In other embodiments, erodible element 702 is formed as a separate element or component that is coupled to one or more portions of device 100. In some such embodiments, erodible element 702 may be coupled to one or more portions of device 100. Alternatively, in some embodiments, erodible element 702 may be coupled to one or more portions of device 100, after which erodible element 702 can be separated and removed from device 100.

[0123] In some such embodiments, the conduit 104 of the device 100 is isolated from interfacing with surrounding ocular tissue (e.g., the sclera or conjunctiva) by incorporating multiple erosive elements (e.g., 702A and 702B). That is, in some embodiments, the device 100 can include one or more erosive elements 702 that isolate the conduit 104 from ocular tissue. For example, the device 100 can be configured such that the erosive elements 702 flank the fluid conduit 104 on either side of a plane that bisects the fluid conduit 104 along the longitudinal axis of the fluid conduit 104. In such a configuration, for example, a first one of the erosive elements 702 can extend along the fluid conduit 104 between the fluid conduit 104 and the sclera of the eye. Similarly, a second one of the erosive elements 702 can extend along the fluid conduit 104 between the fluid conduit 104 and the conjunctiva of the eye. Such a configuration provides erosion protection to both the conjunctiva and sclera of the eye because the fluid conduits 104 are prevented from directly interfacing with the conjunctiva and sclera of the eye when the glaucoma drainage device 100 is implanted in the eye (e.g., when implanted in a pocket formed between the conjunctiva and sclera).

[0124] In various embodiments, erodible element 702 comprises a thin, flexible, porous membrane that is consistent in structure, shape, and configuration with various other thin, flexible, porous membranes described herein. For example, erodible element 702 can include microstructures (e.g., surface 106) configured to resist tissue ingrowth, or alternatively, can include microstructures (e.g., surface 108, such as region 118 shown in FIG. 1B) configured to promote or permit tissue ingrowth. Alternatively, in some embodiments, erodible element 702 can include a structure (which can be single-layered or multi-layered) that includes a first surface (or region thereon) configured to promote or permit tissue ingrowth (e.g., region 118 shown in FIG. 1B) and a second surface (or region thereon) configured to resist tissue or cell ingrowth (e.g., surface 106 shown in FIG. 1B). The permissive / resistant layers or regions in such embodiments are oriented to optimize the effectiveness of glaucoma drainage device 100 when implanted in the eye. For example, as described in more detail below, in various embodiments, erodible element 702 is configured to promote or permit tissue ingrowth along the interface between erodible element 702 and ocular tissue (e.g., the sclera or conjunctiva, etc.). Accordingly, it will be understood that the material of erodible element 702 can include any material and can be constructed according to any method described herein that is appropriate for the layers or regions described herein.

[0125] Thus, in various embodiments, eroding element 702 may be coupled to (or alternatively be an extension of or integral to) any component of body portion 102, as discussed herein. Thus, in some embodiments, eroding element 702 itself may be a membrane or structure having a porosity configured to minimize, resist, or prevent tissue ingrowth, or a membrane or structure having a porosity configured to permit tissue ingrowth.

[0126] In some instances, the eroding element 702 extends away from the body portion 102 of the device 100, as shown. In some embodiments, the eroding element 702 extends away from the outer component 302 of the body portion 102, along the fluid conduit 104 between the fluid conduit 104 and the inner component 300 of the body portion 102. In some embodiments, the eroding element 702 extends between the inner component 300 of the body portion 102 and an end of the fluid conduit 104 configured to access a body cavity filled with biological fluid, such as the anterior chamber of the eye (e.g., a first end or a second end of the fluid conduit 104), which is particularly preferred among other embodiments that will be appreciated by those skilled in the art.

[0127] 9A-9C, 10A-10C, 11A-11G, 12A-12C, 13A-13C, and 14A-14C are described as including a rectangle, but it will be understood that eroding element 702 may be any suitable shape without departing from the spirit or scope of the present disclosure. For example, eroding element 702 may be square, rectangular, trapezoidal, or other polygonal in shape, may include chamfered or rounded edges between sides, and the sides may be straight or generally curved in nature. eroding element 702 may have a generally continuous curved edge that is circular or elliptical, or may be another suitable shape (e.g., bean-shaped). Those skilled in the art will appreciate that erosion element 702 can have any desired shape, so long as it serves to protect the fluid conduit from erosion through the tissue surrounding the fluid conduit, and so long as erosion element 702 can be positioned within the subconjunctival space (such as a pocket formed between the conjunctiva and the sclera) as described herein.

[0128] In some embodiments, the eroding element 702 extends along the length of the fluid conduit but has a length that is less than the length of the portion of the fluid conduit extending from the body portion 102. In other embodiments, the eroding element 702 extends along the length of the fluid conduit but has a length that is equal to or greater than the length of the portion of the fluid conduit extending from the body portion 102. In some embodiments, the eroding element 702 has a width that is equal to or greater than the diameter of the fluid conduit 104. However, in some embodiments, the width of the eroding element 702 may be less than the diameter of the fluid conduit, as long as the eroding element 702 does not become ineffective in protecting the fluid conduit from erosion through the surrounding tissue. Consistent with the variety of suitable sizes and shapes of the eroding element 702 described above, it will be understood that the width of the eroding element 702 can remain constant along the length of the eroding element 702 or, alternatively, the width of the eroding element 702 can vary along the length of the eroding element 702. For example, the width can be tapered (linearly or non-linearly) along the longitudinal length of the eroding element.

[0129] In some embodiments, the eroding element 702 can be configured to be more wear-resistant in high-wear or high-wear regions (e.g., regions where the fluid conduit 104 may move relative to the eroding element 702). Wear resistance in such regions can be achieved according to any known method, including material composition and / or material thickness. Accordingly, the thickness of the eroding element 702 can vary along the length of the eroding element 702 and / or vary transversely across its width. For example, the thickness can be tapered (linearly or non-linearly) along and / or across the length of the eroding element 702. For example, the thickness of the eroding element 702 along its longitudinally extending centerline can exceed the thickness of the eroding element 702 along one or more of its longitudinally extending ends. Alternatively, it is understood that the thickness along the longitudinally extending centerline of the eroding element 702 can be less than the thickness of the eroding element 702 along one or more of its longitudinally extending ends. Additionally or alternatively, the thickness of the eroding element 702 along one section of its longitudinal length may be greater than the thickness of the eroding element 702 along a second section of its longitudinal length. For example, if the region where the fluid conduit 104 accesses the fluid filler cavity corresponds to a high-wear region, the section of the eroding element 702 near the end of the fluid conduit 104 configured to access the fluid filler cavity may be thicker than the section of the eroding element 702 near the body portion 102. It should be appreciated that the thickness of the eroding element 702 can be optimized in the high-wear or high-wear region to reduce the risk of premature failure of the device 100 due to abrasion of the eroding element 702 by the fluid conduit 104. These thickness variations can be achieved by selective layering of the materials that collectively form the eroding element 702 or other known methods.

[0130] In some embodiments, the eroding element 702 can be positioned longitudinally spaced apart from the body portion 102, or can include a region of reduced width (not shown) and / or thickness (not shown) extending between the eroding element 702 and the body portion 102 along a region of the fluid conduit 104 that has a lower risk of erosion through the surrounding tissue. For example, if a portion of the fluid conduit 104 adjacent to the body portion 102 has a lower risk of erosion through the surrounding tissue, the region of reduced width and / or thickness of the eroding element 702 can be positioned adjacent this region of the fluid conduit 104. Alternatively, the eroding element 702 can be configured to expose the fluid conduit 104 to the surrounding tissue in this region of lower risk of erosion. Thus, in some examples, the eroding element 702 may not extend from the body portion 102.

[0131] In some embodiments, the erodible element 702 is coupled to the fluid conduit 104. The erodible element 702 may be coupled to the fluid conduit 104 continuously along the length of the fluid conduit 104 or at one or more discrete locations along the fluid conduit 104. The erodible element 702 may be coupled to the fluid conduit 104 according to known methods, including, but not limited to, suturing or stitching the erodible element along the length of the conduit. In some embodiments, the sutures can be a series of interrupted sutures or a continuous running stitch. Additionally or alternatively, the fluid conduit 104 can be mechanically bonded to the erodible element 702 by partially fusing the fluid conduit 104 to the microporous structure of the erodible element 702. In some embodiments, the erodible element 702 can be coated with a tacky adhesive to allow the fluid conduit 104 to be removably bonded to the erodible element 702. In some embodiments, one or more bands of material (e.g., microporous material) can be bonded at their ends to the erodible element 702 such that an eyelet is formed between the band of material and the erodible element 702, allowing the fluid conduit 104 to pass through the gap. In some instances, as shown in FIG. 11D, a trimmable portion 703 of the erodible element 702 can be trimmed (e.g., by cutting) by a physician to adjust the length or area of ​​the erodible element 702 by removing portions not required for the procedure. In some instances, there can be multiple trimmable portions 703A and 703B, such as when there are multiple erodible elements (e.g., 702A and 702B as shown), as shown in FIG. 11E.

[0132] 14A-14B illustrate an example of a device 100 in which the body portion 102 includes one or more third surfaces 1400. The third surface 1400 can be defined as a region within the second surface 108 (which, in the illustrated example, corresponds to the second surface 108B of the outer component 302 of the body portion 102) opposite the first surface 106 (which, in the illustrated example, corresponds to the first surface 106B of the outer component 302 of the body portion 102). The third surface 1400 is discontinuous from the second surface 108 and has a third porosity that is lower than the second porosity of the second surface 108, similar to the low porosity region 120 described elsewhere herein. In some examples, the third porosity of the third surface 1400 is equal to the first porosity of the first surface 106.

[0133] 14C , where the recess is formed by removing a portion of body portion 102 (or, in the illustrated example, a portion of outer component 302 of body portion 102) having the second (higher) porosity. According to some examples, third surface 1400 can be a recess formed by applying one or more pressures to reduce the thickness of body portion 102 (or, in the illustrated example, outer component 302 of body portion 102).

[0134] In the illustrated example, there are three third surfaces 1400A, 1400B, and 1400C and two additional inner components 1200A and 1200B. Accordingly, the positions of these third surfaces and additional inner components may be determined such that each third surface 1400 may be disposed on the outer component 302 of the body portion 102 opposite one of the additional inner components 1200 (e.g., third surface 1400A may be paired with the additional inner component 1200A, and third surface 1400B may be paired with the additional inner component 1200B). In some examples, there may be a third surface that is not paired with an additional inner component, such as third surface 1400C.

[0135] Advantages of implementing embodiments of the drainage device as disclosed herein include enabling the formation of a significantly thinner conjunctival capsule compared to current Ahmed glaucoma valve solid silicone plate "tube shunts" known in the art (see, e.g., the prior art examples shown in FIGS. 15A-15C), and the implementation of an open, collapsible body portion as disclosed herein helps reduce stress on the conjunctiva by the device during implantation, thereby minimizing stress on the eye when subjected to pressure from the AC. Thinness can provide advantages such as, but not limited to, requiring less material for fabrication, simpler design to manufacture and modify, lighter weight, thinner profile, minimally invasive implantation, and the lack of a chamber or reservoir, which prevents the device from filling with cells and cellular debris during long-term use, thereby increasing device longevity.

[0136] Furthermore, the interior of the body portion, having sufficient microporosity, defines the surface area of ​​the device through which aqueous flux (fluid flow) occurs. One outer surface of the device can have a microporosity large enough to promote tissue ingrowth, while the opposite outer surface of the body portion can have a microporosity small enough to prevent tissue ingrowth from reaching the opposite outer surface, thereby allowing an adequate amount of tissue ingrowth to occur on one surface of the device while mitigating the problem of excessive tissue ingrowth on both surfaces of the device and allowing fluid to flow appropriately from one surface (e.g., from the eye) to the other surface (e.g., into the conjunctiva). Furthermore, the conduit (tube) is protected from the conjunctiva by locating the conduit on the scleral side of the body portion as described. Such protection can be beneficial, for example, to reduce the risk of the conduit becoming clogged at the distal end (conjunctival end) of the device. Furthermore, a reinforcing element, such as a support structure (or component thereof) located around the periphery of the device, can aid the practitioner (e.g., a doctor, surgeon, or physician) in handling the device for implantation procedures while minimizing the risk of the practitioner accidentally bending the body portion of the device inside the body. Bending can reduce the effectiveness of the device or even render it useless.

[0137] Various modifications and additions can be made to the exemplary embodiments described 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. 1. A drainage device for draining biological fluid from an eye to tissue external to the eye, comprising: the drainage device is at least partially implantable within an ocular tissue; The drainage device comprises: an open, collapsible body portion having a first surface with a first porosity and a second surface with a second porosity greater than the first porosity, the second surface opposite the first surface; and a conduit having a first end fluidly coupled to the first surface and a second end insertable into the eye, the conduit facilitating drainage of biological fluid into the conduit; wherein the second surface having a second porosity includes at least one ingrowth surface area for promoting ingrowth of tissue external to the eye.

2. The drainage device of claim 1 , wherein the first surface having the first porosity is configured to inhibit ingrowth of tissue outside the eye.

3. 3. The drainage device of claim 1 or 2, wherein the second surface further comprises at least one low porosity region for inhibiting ingrowth of tissue outside the eye.

4. 4. The drainage device of claim 3, wherein at least one low porosity region of the second surface defines a third surface opposite the first surface, the third surface being discontinuous from the second surface and having a third porosity lower than the second porosity.

5. The drainage device of claim 4 , wherein the third porosity is equal to the first porosity.

6. The drainage device of any one of claims 1 to 5, wherein the body portion includes a plurality of interior regions having a porosity greater than the first porosity and less than the second porosity.

7. The drainage device according to any one of claims 1 to 6, wherein the conduit is attached to the periphery of the body portion.

8. A drainage device according to any preceding claim, wherein the conduit is attached to the body portion over at least 50% of the cross-sectional length of the body portion.

9. The drainage device of any one of claims 1 to 6, wherein the conduit is attached to the first surface of the body portion at an attachment region, and the body portion further includes an erosion element having a trimmable portion extending outward from the attachment region relative to the conduit.

10. The drainage device of claim 9 , wherein the erodible element is a separate component from the body portion.

11. The drainage device of claim 9 , wherein the erodible element is a continuous extension of the body portion.

12. The body portion is an inner component having a first surface with a first surface porosity and a second surface with a second surface porosity greater than the first surface porosity; an outer component having a first surface having a first surface porosity and a second surface having a second surface porosity greater than the first surface porosity; Including, The drainage device of any one of claims 1 to 11, wherein the inner component and the outer component are arranged so that the first surface of the inner component faces the first surface of the outer component.

13. The drainage device of claim 12 , wherein the conduit is disposed between the first surface of the inner component and the first surface of the outer component.

14. further comprising one or more additional internal components each having a first surface with a first surface porosity and a second surface with a second surface porosity greater than the first surface porosity; 14. The drainage device of claim 12 or 13, wherein the additional inner components are attached to the outer component such that each of the first surfaces of the additional inner components faces the first surface of the outer component.

15. The drainage device of any preceding claim, further comprising a support structure attached to at least a portion of the body portion.

16. The drainage device of claim 15 , wherein the conduit is attached to a portion of the support structure.

17. 17. The drainage device of claim 15 or 16, wherein the support structure comprises one or more thermoplastic components.

18. The drainage device of claim 17 , wherein one or more channels are formed between two of the thermoplastic components and configured to allow biological fluid to pass through the channels.

19. A drainage device according to any one of claims 15 to 18 dependent on claim 12, wherein the support structure is disposed between the first surface of the inner component and the first surface of the outer component.

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