Biological fluid drainage device and method

Abstract

A drainage device for draining a biological fluid from an eye to tissue outside the eye. The drainage device may be at least partially implanted within tissue of the eye. The drainage device includes: an open collapsible body portion having a first surface having a first porosity and a second surface having a second porosity greater than the first porosity, the second surface being opposite the first surface; and a catheter having a first end fluidly coupled with the first surface and a second end insertable into the eye to facilitate drainage of biological fluid into the catheter. The second surface having a second porosity includes at least one ingrowth surface region for promoting ingrowth of tissue outside the eye.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Application No. 63 / 401,258, filed on August 26, 2022, and U.S. Application No. 18 / 237,045, filed on August 23, 2023, the entire contents of both of which are incorporated herein by reference for all purposes. Technical Field

[0002] The present disclosure generally relates to devices and methods for draining biological fluids and transferring fluids to be reabsorbed elsewhere in the body. More specifically, the present disclosure relates to devices and methods for draining aqueous humor from the anterior chamber (AC) of a patient's eye so that the aqueous humor can be reabsorbed by the body. Background Art

[0003] Various medical interventions involve draining excess biological fluid from one part of the body and redirecting it to another location of the body where the fluid can be reabsorbed. In some cases, this drainage is achieved through minimally invasive surgery, such as endoscopic third ventriculostomy (ETV) and choroid plexus cauterization (CPC). In other cases, this drainage is performed postoperatively via an implantable medical device such as a shunt. Different forms of shunts have been used to treat a variety of diseases, such as hydrocephalus and glaucoma, which have proven useful in various medical procedures.

[0004] If left untreated, excess biofluid can lead to an unhealthy buildup of pressure. For example, glaucoma is a progressive eye disease characterized by elevated intraocular pressure. Aqueous humor is a fluid that fills the anterior chamber (AC) of the eye and contributes to intraocular pressure or fluid pressure within the eye. This rise in intraocular pressure is usually caused by insufficient amounts of aqueous humor being absorbed by the body. In some cases, the aqueous humor is not absorbed quickly enough or is not even absorbed at all, while in other cases, the aqueous humor is additionally or alternatively produced too quickly. Elevated intraocular pressure is associated with a gradual and sometimes permanent loss of vision in the diseased eye.

[0005] Various attempts to treat glaucoma have been made, including devices that are relatively bulky, inflexible, non-compliant, and lack a firm anchoring capability to the surrounding tissue resulting in relative motion between the device and the tissue. This motion may result in continued irritation of the surrounding tissue, causing irritation at the implant site. Irritation, in turn, may result in increased chronic inflammatory tissue response, excessive scarring at the device site, and an increased risk of device corrosion through conjunctivitis and endophthalmitis. Scar tissue effectively prevents reabsorption of aqueous humor without corrosion and interferes with device function. Summary of the invention

[0006] Disclosed herein are devices for draining biological fluids from an eye to tissue surrounding the eye, methods of forming the devices that are at least partially implantable within tissue of the eye, and methods of 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 outside the eye is disclosed. The drainage device can be at least partially implanted in the tissue of the eye. The drainage device includes: an open collapsible body portion having a first surface and a second surface, the first surface having a first porosity, the second surface having a second porosity greater than the first porosity, the second surface being opposite to the first surface; and a conduit having a first end and a second end, the first end being fluidly coupled to the first surface, and the second end being insertable into the eye to promote drainage of biological fluid into the conduit. The second surface having the second porosity includes at least one ingrowth surface region for promoting ingrowth of tissue outside the eye.

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

[0009] According to another example further to Example 1 or 2 ("Example 3"), the second surface also includes at least one low-porosity region for inhibiting the in-growth of tissue outside the eye.

[0010] According to another example further relative to Example 3 (“Example 4”), at least one low porosity region in the second surface defines a third surface opposite to the first surface, the third surface is discontinuous with the second surface and has a third porosity less than the second porosity.

[0011] According to another example (“Example 5”) further relative to Example 4, the third porosity is equal to the first porosity.

[0012] According to another example (“Example 6”) further relative to any of the aforementioned examples, the main body portion includes a plurality of internal regions, and the porosity of the internal regions is greater than the first porosity and less than the second porosity.

[0013] According to another example ("Example 7") further to any of the preceding examples, the conduit is attached to a perimeter of the body portion.

[0014] According to another example (“Example 8”) further to any of Examples 1-6, the conduit is attached to the body portion across at least 50% of the cross-sectional length of the body portion.

[0015] According to another example further to any one of Examples 1-6 ("Example 9"), the catheter is attached to the first surface of the main body at an attachment area, and the main body also includes an anti-corrosion element having a trimmable portion, which extends outward from the attachment area relative to the catheter.

[0016] According to another example (“Example 10”) further to Example 9, the corrosion protection element is a component separate from the main body portion.

[0017] According to another example (“Example 11”) further to Example 9, the corrosion protection element is a continuous extension of the main body portion.

[0018] According to another example ("Example 12") further relative to any of the foregoing examples, the body portion includes: an inner component having a first surface and a second surface, the first surface having a first surface porosity, the second surface having a second surface porosity greater than the first surface porosity; and an outer component having a first surface and a second surface, the first surface having a first surface porosity, the second surface having a second surface porosity greater than the first surface porosity. 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.

[0019] According to another example (“Example 13”) further to Example 12, 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 further to Example 12 or 13 ("Example 14"), the device also includes one or more additional internal components, each additional internal component having a first surface and a second surface, the first surface having a first surface porosity, and the second surface having a second surface porosity greater than the first surface porosity. The additional internal components are attached to the external component so that the first surface of each additional internal component faces the first surface of the external component.

[0021] According to another example ("Example 15") further relative to any of the preceding examples, the device also includes a support structure attached to at least a portion of the body portion.

[0022] According to another example (“Example 16”) further to Example 15, the conduit is attached to a portion of the support structure.

[0023] According to another example (“Example 17”) further to Example 15 or 16, the support structure includes one or more thermoplastic components.

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

[0025] According to another example (“Example 19”) further to any one of Examples 15-18, 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 examples and should not be construed as limiting or otherwise narrowing the scope of any inventive concept otherwise provided in this disclosure. Although a number of examples are disclosed, still other examples will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples. Therefore, the drawings and detailed description should be considered illustrative in nature and not restrictive in nature. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The accompanying drawings are included to provide a further understanding of the disclosure and are incorporated in and constitute a part of this specification, illustrate embodiments and together with the description serve to explain the principles of the disclosure.

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

[0029] Figure 1B is a SEM image of a portion of a cross-sectional view of a drainage device according to an embodiment disclosed herein (the image is shown to the scale indicated in the figure);

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

[0031] Figure 1D is a microscopic image of a tissue slide stained with a tissue stain of a cross-sectional view of a drainage device according to an embodiment disclosed herein (the image is shown to the scale indicated in the figure);

[0032] Figure 1E is a schematic diagram of a partial view of a multi-lumen fluid conduit according to an embodiment disclosed herein;

[0033] Figure 2A and 2B is a bottom view schematic diagram of a drainage device according to an embodiment disclosed herein;

[0034] Figure 3 is a cross-sectional schematic diagram of a drainage device according to an embodiment disclosed herein;

[0035] Figures 4 to 6 is an oblique schematic diagram of a drainage device according to an embodiment disclosed herein;

[0036] Fig. 7A is a bottom view schematic diagram of a drainage device according to an embodiment disclosed herein;

[0037] Figure 7B yes Fig. 7A A top view schematic diagram of a drainage device;

[0038] Figure 7C yes Figure 7B A schematic cross-sectional view of the drainage device taken across line C-C;

[0039] Fig. 8A is a bottom view schematic diagram of a drainage device according to an embodiment disclosed herein;

[0040] Figure 8B yes Fig. 8A A top view schematic diagram of a drainage device;

[0041] Figure 8C yes Figure 8B A schematic cross-sectional view of the drainage device taken across line C-C;

[0042] Fig. 9A is a bottom view schematic diagram of a drainage device according to an embodiment disclosed herein;

[0043] Fig. 9B yes Fig. 9A A top view schematic diagram of a drainage device;

[0044] Fig. 9C yes Fig. 9B A schematic cross-sectional view of the drainage device taken across line C-C;

[0045] Fig. 10A is a bottom view schematic diagram of a drainage device according to an embodiment disclosed herein;

[0046] Fig. 10B yes Fig. 10A A top view schematic diagram of a drainage device;

[0047] Fig. 10C yes Fig. 10B A schematic cross-sectional view of the drainage device taken across line C-C;

[0048] Fig.11A is a bottom view schematic diagram of a drainage device according to an embodiment disclosed herein;

[0049] Fig. 11B yes Fig.11A A top view schematic diagram of a drainage device;

[0050] Fig. 11C yes Fig. 11B A schematic cross-sectional view of the drainage device taken across line C-C;

[0051] Fig.11D and 11Eis a device with two different attachment positions according to the embodiments disclosed herein Fig.11A A bottom view schematic diagram of a drainage device;

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

[0053] Fig.11G yes Fig.11F A photograph of a bottom view of the drainage device;

[0054] Fig. 12A is a bottom view schematic diagram of a drainage device according to an embodiment disclosed herein;

[0055] Fig. 12B yes Fig. 12A A top view schematic diagram of a drainage device;

[0056] Fig. 12C yes Fig. 12B A schematic cross-sectional view of the drainage device taken across line C-C;

[0057] Fig.13A is a bottom view schematic diagram of a drainage device according to an embodiment disclosed herein;

[0058] Fig. 13B yes Fig.13A A top view schematic diagram of a drainage device;

[0059] Fig. 13C yes Fig. 13B A schematic cross-sectional view of the drainage device taken across line C-C;

[0060] Fig.14A is a bottom view schematic diagram of a drainage device according to an embodiment disclosed herein;

[0061] Fig. 14B yes Fig.14A A top view schematic diagram of a drainage device;

[0062] Fig. 14C yes Fig. 14B A schematic cross-sectional view of the drainage device taken across line C-C;

[0063] FIG. 15A (PRIOR ART) is a photograph of a top view of an Ahmed Glaucoma Valve modified with a polyethylene shell and implemented with a solid plate as is known in the art;

[0064] FIG. 15B (PRIOR ART) is a photograph of a side view of the prior art glaucoma valve shown in FIG. 15A with a portion of the solid plate removed to illustrate the reservoir located therein; and

[0065] 15C (PRIOR ART) is a SEM image of a portion of the surface of a solid plate used in the prior art glaucoma valve shown in FIG. 15A (the image is shown to scale as indicated in the figure).

[0066] It should be understood that the drawings and photographs are not necessarily reproduced to scale unless otherwise indicated. In some cases, details that are not necessary for understanding the present disclosure or details that make other details difficult to perceive may be omitted. Of course, it should be understood that the present disclosure is not necessarily limited to the specific examples or embodiments described or depicted herein. DETAILED DESCRIPTION Definitions and terminology

[0067] This disclosure is not intended to be read in a limiting manner.For example, the terms used in this application should be read broadly in the context of the meaning that one skilled in the art would attribute to such terms.

[0068] Regarding imprecise terms, the terms "about" and "approximately" are used interchangeably to refer to measurements including the measured value and also any measurements that are reasonably (fairly) close to the measured value. As understood and easily determined by a person of ordinary skill in the relevant art, a measurement that is reasonably (fairly) close to the measured value deviates from the measured value by a reasonably small amount. Such deviations may be attributed to, for example, measurement errors, differences in calibration of the measured values ​​and / or manufacturing equipment, human errors in reading and / or setting the measured values, fine-tuning to optimize performance and / or structural parameters in view of differences in the measured values ​​associated with other components, specific implementation scenarios, imprecise adjustments and / or manipulations of objects by humans or machines, and / or the like. In the case where it is determined that a person of ordinary skill in the relevant art will not easily determine a value for such a reasonably small difference, the terms "about" and "approximately" may be understood as the value plus or minus 10%.

[0069] The phrases "at least one", "one or more", and "and / or" are open-ended expressions that can be either conjunctive (combined) or disjunctive when the expressions are effective. For example, each of 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" refers to A alone; B alone; C alone; A and B together; A and C together; B and C together; or A, B, and C together. When each of A, B, and C in the above expressions refers to an element, such as X, Y, and Z, or a class of elements, such as X1-X n 、Y1-Y m and Z1-Z oWhen the phrase is used, it means a single element selected from X, Y and Z, a combination of elements selected from the same category (e.g., X1 and X2), and a combination of elements selected from two or more categories (e.g., Y1 and Z o ).

[0070] It should be understood that each maximum numerical limitation given throughout this disclosure is considered to include each lower numerical limitation as an alternative, just as these lower numerical limitations are clearly written in this article. Each minimum numerical limitation given throughout this disclosure is considered to include each higher numerical limitation as an alternative, just as these higher numerical limitations are clearly written in this article. Each numerical range given throughout this disclosure is considered to include each narrower numerical range that falls within such a wider numerical range, just as these narrower numerical ranges are clearly written in this article.

[0071] Before any embodiment of the present disclosure is described in detail, it should be understood that the present disclosure is not limited to the application thereof to the details of the construction and the arrangement of the parts described in the following description or shown in the accompanying drawings. The present disclosure can have other embodiments and can be practiced or implemented in various ways. Moreover, it should be understood that the words and terms used herein are for descriptive purposes and should not be considered as limiting. As used herein, "including", "comprising" or "having" and variations thereof are intended to include the items listed thereafter and their equivalents and additional items.

[0072] As used herein, the term "fibril" refers to an elongated material such as a polymer, whose length and width are substantially different from each other. For example, a fibril may resemble a string or fiber, wherein the width (or thickness) is much shorter or smaller than the length.

[0073] The term "node" as used herein describes the point of connection of at least two fibrils, wherein a connection can be defined as a location where two fibrils permanently or temporarily contact each other. In some examples, a node can also be used to describe a volume of polymer that is larger than a fibril, as well as a location where a fibril originates or terminates without a clear continuation of the same fibril through the node. In some examples, a node is wider than a fibril but shorter than a fibril.

[0074] As used herein, "node" and "fibril" may be used to describe objects that are typically, but not necessarily, connected or interconnected and, for example, of microscopic size. A "microscopic" object may be defined as an object having at least one dimension (width, length, or height) that is so small that the object or details of the object cannot be seen by the naked eye, or are difficult or even impossible to observe without the aid of a microscope (e.g., including but not limited to a scanning electron microscope or SEM) or any appropriate type of magnification device. Description of various embodiments

[0075] Various embodiments are directed to drainage devices that may be implanted in the eye to drain these fluids from the AC of the eye and accommodate means to avoid or prevent hypotony. However, many prior art drainage devices merely define a lumen to redirect fluid from the AC to a different location at a lower pressure than the AC and therefore do not include any components to redirect the flow of fluid after the fluid leaves the AC. In other words, in contrast to the various embodiments described herein, such drainage devices do not include components to contain the fluid when it reaches a location at a lower pressure than the AC.

[0076] Furthermore, in contrast to some of the embodiments described herein, some prior art drainage devices only provide an initial flow restriction during implantation of the drainage device. For example, devices using a dissolvable plug segment provide an initial outflow resistance to avoid hypotony and hypotony in the early postoperative period, and then increase the flow over time by reducing the outflow resistance to compensate for the increased biological outflow resistance after the surgery is complete, but do not provide a long-term method to avoid or prevent hypotony in the eye.

[0077] Other prior art drainage devices may implement solid plates, such as the plates made of silicone shown in Figures 15A to 15C, to receive fluid from the AC of the eye and store it within an internal chamber formed between the plates. The device shown in Figures 15A and 15B is the Ahmed Glaucoma Valve Model M4 (New World Medical, Inc., Rancho Cucamonga, CA), which has a polyethylene shell to reduce the fibrotic reaction around the drainage plate compared to the S2 and FP7 models in patients with glaucoma, as previously disclosed in Kim J, Allingham RR, Hall J, et al., "Clinical experience with a novel glaucomadrainage implant," Journal of Glaucoma, February 2014; 23(2): e91-7. DOI: 10.1097 / ijg.0b013e3182955d73. PMID: 23689073. The prior art device is made of a tube (T) mounted between two layers (L1 and L2) of a solid material, such as a porous polyethylene shell (e.g., Medpor), which follows the curvature of the eye and defines a reservoir (R) between layers L1 and L2, the tube directing fluid from the eye into the reservoir. As shown in the prior art device of FIG. 15C , which is scaled so that the black bar at the bottom of the figure represents 500 μm, the surfaces of layers L1 and L2 include pores to improve tissue integration, allowing adjacent tissue to be integrated into the polyethylene shell surrounding the drainage device, and ensuring that fluid stored inside the reservoir R can be released back to the surrounding environment to prevent the shell from exerting excessive pressure on the surrounding tissue.

[0078] However, compared to the various embodiments described herein, implanting a solid or rigid material (i.e., a material that lacks flexibility and thinness) inside the eye, such as the material shown in Figures 15A to 15C, increases the pressure exerted on the eye, especially when subjected to pressure from the AC, which increases the pressure within the conjunctival tissue of the eye, which may not only cause discomfort, but also lead to other complications caused by long-term increased pressure in sensitive areas of the eye.

[0079] Those skilled in the art will readily appreciate that various aspects of the present disclosure may be implemented by any number of methods and devices configured to perform the desired functions. It should also be noted that the drawings referenced herein are not necessarily drawn to scale (unless otherwise specified), but may be exaggerated to illustrate various aspects of the present disclosure, and in this regard, the drawings should not be construed as limiting.

[0080] Various aspects of the present disclosure relate to drainage devices and methods for biological fluids. For example, the present disclosure relates to devices and methods for draining biological fluids from an eye ( Figure 1C ) to drain aqueous humor from the anterior chamber (AC) so that it can be reabsorbed elsewhere by the body. Figure 1C An eye is shown in which there is a subconjunctival space between the conjunctiva and sclera of the eye. A drainage system having a drainage device 100 according to the principles of the present disclosure is implanted in the eye. In one aspect of the present disclosure, a mechanism is provided for reabsorbing aqueous humor that has been drained from the AC of the eye to reduce or otherwise stabilize intraocular pressure. However, those skilled in the art will appreciate that various aspects of the present disclosure are useful in other applications where drainage of biological fluids to be redirected in vivo is desired. In some examples, the target implant location may include a subconjunctival and / or sub-Tenon location of the eye. In some examples, the device 100 may be at least partially implanted subconjunctivally and at least partially implanted suprachoroidally (e.g., posterior to the pars plana) as appropriate for the intended treatment.

[0081] Various embodiments and examples of drainage devices 100 for treating glaucoma are disclosed herein. For example, Figure 1A An example of a device 100 is shown. As shown, the device 100 is an implantable device that can be used to drain biological fluids from the eye when at least partially implanted in the tissue of the eye. In some examples, the fluid can be drained to the tissue surrounding the eye or the tissue outside the eye. The device 100 includes an open collapsible main body portion 102 and a fluid conduit 104. The main body portion 102 has a first surface 106 and a second surface 108, the first surface 106 having a first porosity, and the second surface 108 having a second porosity greater than the first porosity. The second surface 108 is opposite to the first surface 106 (or is disposed at a position of the main body portion 102 opposite to the position of the first surface 106). The main body portion 102 is "open" because there is no enclosed space or chamber therein, thereby lacking a 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 in the range of 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 100 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 thereof. In some examples, the main body portion 102 may have a diameter in the range of 5 mm to 15 mm, such as 10 mm. In some embodiments, the main body portion 102 may be ovoid and 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 described above, for different anatomical structures of the human body, the main body portion 102 may exceed such dimensions (e.g., 10 mm, 15 mm, and 30 mm), provided that such dimensions do not substantially interfere with normal eye functions (e.g., pivoting and blinking) or substantially reduce the flexibility of the aqueous humor diffusion member to the extent that undesirable relative movement occurs between the drainage device 1000 and the surrounding tissue when implanted, resulting in possible results of tissue irritation, foreign body tissue reaction, and / or excessive scar formation. Similarly, the main body portion 102 may have a diameter of less than 5 mm, 3 mm, or even less than 3 mm, provided that the main body portion 102 is operable to accommodate a sufficient degree of drained aqueous humor and is operable to promote reabsorption of aqueous humor to constitute an 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 that allows fluid to pass through. The first end 110 is fluidically coupled to the first surface 106, and the second end 112 can be inserted into the patient's eye to facilitate the drainage of biological fluid into the conduit 104. Throughout the figures disclosed herein, dashed arrows indicate the general direction of fluid flow relative to the components of the device 100. For example, in Figure 1A In the embodiment of the present invention, the fluid may flow into the lumen 114 of the conduit 104 via the second end 112, and exit via the first end 110 after passing through the lumen 114. Thereafter, the fluid may flow away from or toward the body portion 102, such that the fluid enters the body portion 102 from the first surface 106, travels through the material of the body portion 102, and exits the body portion 102 from the second surface 108. Figure 1BAs shown, the second surface 108 having the second porosity further includes at least one ingrowth surface region 118 that promotes tissue ingrowth.

[0084] Figure 1B A microscopic view of a microporous material of an outer surface (second surface 108) of a body portion 102 of a device 100 according to some embodiments is shown. The body portion 102 includes a plurality of interior regions 116 between the first surface 106 and the second surface 108, the porosity of which is greater than the first porosity and less than the second porosity. Figure 1B At the bottom of the display, it says: "5.00kV 4.2mmx500 SE 1 / 23 / 2018", and the distance between the two continuous lines shown in the lower right corner represents 10μm. For example, Figure 1B The microporous material can be referenced throughout the text with respect to medical implant devices or systems. Figure 1B It will be appreciated that the microporous aspects and parameters of a microporous material can be defined in a variety of ways. In applications of microporous materials in ocular devices, such as the device 100 described herein, which is configured to be placed in situ in ocular tissue to facilitate drainage of biological fluid from the eye (as indicated by the white arrows labeled "Fluid Flow," which indicate the direction of flow of the biological fluid relative to the first surface 106 and the second surface 108), the microporous properties of such microporous materials can generally be characterized by a volume porosity value, which can be defined as the ratio of the volume of air or fluid defined by and contained in the microporous material compared to the entire volume (or total volume) of the microporous material.

[0085] In another definition, volume porosity can be defined as the percentage of the volume of a microporous material that is occupied by nonstructural or transient elements such as air or other fluids. For example, a total volume of 100 mm 3 And the total volume of 30mm 3 A microporous material that includes chambers that hold air or fluid would have a volume porosity value of 0.3 because 30% of the volume of the microporous material is either transient space that is filled with air or other fluid or is empty.

[0086] As can be appreciated, two microporous materials can have the same volume porosity but differ in the pore size (pore size) presented to air or fluid entering or leaving. For example, a first material can have a small number of large pores distributed over a fixed total volume, and a second material can have a relatively large number of relatively smaller pores distributed over the same fixed volume, and if the air / fluid volume of the two materials is the same, then the two microporous materials can have the same volume porosity.

[0087] As can be further appreciated, the properties of the microporous material used in the ocular drainage device can also be defined by the size of the channels through the microporous material, or similarly defined as the pore size measured at the surface where the channel terminates at the microporous material or the pore size measured along the length of the channel within the material. Microporous materials with small pores or channels can impede flow through the material, while relatively larger pores or channels can provide increased throughput of air or fluid into, out of, or within the microporous material.

[0088] As still further understood, the properties of microporous materials can also be defined by the tortuosity of the channels into and through the material, where relatively small or large channels present obstructed fluid paths due to the frequency of turns in the channels or due to the placement of obstacles in the fluid path. The air / fluid permeability of microporous materials can be managed by controlling or defining any of the above characteristics of the material to provide a suitable material for use in the eye to promote drainage of biological fluids from the eye.

[0089] For simplicity, the aforementioned characteristics and variables of the microporous materials used in the various embodiments and examples described herein may be presented simply as porosity, which may be based on volume porosity, pore or channel size, or (metric) tortuosity. Figure 1B , the interior portion of the microporous material may have a varying porosity (or volume porosity, or pore size, or tortuosity). The interior portion may extend between an inner surface (first surface 106) and an outer surface (second surface 108).

[0090] At any of these portions of the body portion 102, the porosity can be relatively ranged in degree as small pore size (SP), small and medium pore size (MSP), medium pore size (MP), medium and large pore size (MLP), and large pore size (LP). For the purposes of discussion herein, assuming that delivery travels along a relatively straight path through the microporous material to sequentially join the porosities of the inner surface 106, the uniform inner portion, and the outer surface 108, the combined flow resistance can be expressed as connecting their respective porosities in the same manner. For example, the inner surface 106 typically has an overall low porosity (e.g., to resist tissue ingrowth through the body portion 102 and / or maintain a plane between the device 100 and the sclera), and portions of the inner portion and the outer surface 108 may have any of the aforementioned degrees of porosity. In these cases, when the inner portion has a medium porosity and, for example, the inner portion has a medium porosity and the outer surface 108 has a high porosity, the drainage of biological fluids from the eye through the microporous material to the tissue surrounding the device can be expressed as SP-MP-LP. More examples are discussed here below.

[0091] Various delivery paths may exist within the microporous material. Relatively linear flow paths may include regions SP1-SP4-SP5, for example, or SP3-MLP1-MP1-MSP1. While some flow paths may be relatively straight, non-linear flow paths also exist. For example, under certain conditions, at least some flow may continue to flow through regions of gradually decreasing resistance, such as SP1-LP1-LP2 or SP3-MLP1-LP1-LP2. As will be appreciated, the microstructure of the microporous material may undergo modification processes to obtain certain types of flow through the microstructure. For example, the microstructure may have multiple layers that are relatively uniform across the stratification within the microstructure, or, as shown here, the microstructure may have a variable portion across the (entire) thickness of the microporous material.

[0092] In some examples, the body portion 102 defines a wall portion thickness extending between the inner surface 106 and the outer surface 108. The wall portion thickness can define an interior region of the body portion 102 having a transition porosity between the porosity of the low porosity surface of the inner surface 106 (e.g., having a smaller pore size) and the porosity of the high porosity surface of the outer surface 108 (e.g., having a larger pore size). Additionally or alternatively, the interior region can have an interior region porosity that is equal to the porosity of the low porosity surfaces of the inner surface 106 and the outer surface 108. Additionally or alternatively, the interior region can have an interior region porosity that is 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 that is equal to the porosity of the high porosity surface of the outer surface 108.

[0093] Still refer to Figure 1B , the fluid path may also be affected by a pressure difference between a fluid in one region (e.g., at the first surface 106) and a fluid in another region (e.g., at the second surface 108). In some examples, the first surface 106 has a first porosity that prevents or inhibits tissue ingrowth. In some examples, the second surface 108 includes at least one low porosity region 120 for inhibiting tissue ingrowth. The region capable of inhibiting tissue ingrowth may have a relatively small pore size, such as, for example, a labeled SP and / or MSP.

[0094] Figure 1C An exemplary location is shown where the device 100 can be implanted in the eye. In the example shown, the size and shape of the device 100 are designed so that the device can be implanted in an anatomical subconjunctival space, such as between the sclera and conjunctiva of the patient's eye.

[0095] As described above, in various embodiments, the fluid conduit is a soft and pliable tubular member that can be inserted into the anterior chamber of the eye. In various exemplary surgical methods, one or more of the fluid conduit and the aqueous humor diffusion member are advanced or pushed during the implantation procedure. Soft, thin and compliant tubular structures are generally difficult to advance through tissue. Therefore, in various embodiments, the glaucoma drainage system discussed herein may also include a reinforcing member, such as a support structure, integrated with the device. The reinforcing member can form a mounting assembly with a column strength that exceeds the column strength of the fluid conduit. The treatment method may include using the reinforcing member to advance the main body of the device to the implantation position.

[0096] In some examples, as will be appreciated by those skilled in the art, the device 100 may be implanted from the inside (e.g., from the inside of the eye), such as through a clear corneal incision, and placed through the sclera and into the anatomical subconjunctival space. In some other embodiments, as will be appreciated by those skilled in the art, the device 100 may be implanted from the outside (e.g., from the outside of the eye), such as through a conjunctival incision. In some embodiments, a conjunctival radial incision (radial incision) may be performed, typically near the limbal junction, and a blunt dissection of the conjunctiva may be performed to expose the sclera and provide a site for placement of an aqueous humor diffusion member. In some embodiments, this may require suturing the aqueous humor diffusion member to the sclera. In some embodiments, a small needle, typically a 22 or 23 gauge needle, may also be inserted near the scleral process to provide a track for subsequent insertion and placement of a fluid catheter into the AC. Similarly, it will be understood that the various fluid catheter variations described above may be performed through one or more of an intra-abdominal clear corneal approach and an extra-abdominal approach.

[0097] Figure 1Dis an exemplary image of a histopathological tissue section showing an open collapsible main body portion 102 and how the conjunctival tissue of the eye interacts or engages with the main body portion 102. In the image, the section is stained with Masson's Trichrome (a histological stain) at 20 times magnification (the bar in the lower right corner shows a scale of 100 μm), so that collagen is stained blue and tissue cells are stained red. The main body portion 102 includes a first surface 106 and a second surface 108, and the second surface 108 includes a plurality of ingrown surface regions 118 and a low porosity region 120. The ingrown surface region 118 allows tissue cells 122 from the conjunctiva to be received therein so that the tissue cells 122 grow inwardly into a portion of the second surface 108, while the low porosity region 120 prevents or otherwise significantly inhibits the ingrown tissue cells 122. The first surface 106 is free of or absent any tissue cells or collagen, indicating that while the second surface 108 may 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.

[0098] Additionally or alternatively, in various embodiments, the fluid conduits 104 of the various glaucoma drainage devices discussed herein may be configured such that they include a plurality of lumens 114 . Figure 1E An example of a catheter 104 having four lumens 114A, 114B, 114C, and 114D is shown through which fluid can enter (via the second end 112) and exit (via the first end 110) the catheter 104. In some embodiments, one or more lumens of the multi-lumen fluid conduit 104 can be initially blocked, and wherein one or more lumens 114 (e.g., 114A to 114D) of the multi-lumen fluid conduit 104 can be unblocked post-operatively to increase the fluid flow rate through the fluid conduit 104. Thus, in various embodiments, the various glaucoma drainage devices discussed herein may include one or more mechanisms that can be modified post-operatively to increase and / or decrease the aqueous humor permeability per unit time of the glaucoma drainage device. Thus, the glaucoma drainage devices discussed herein can dynamically change to accommodate changes in the anatomy or function of the patient's eye post-operatively without requiring further invasive surgery.

[0099] Figure 2A and 2BEach shows an example of a drainage device 100 having a support structure 200 attached to at least a portion of the body portion 102. The support structure 200 is positioned at the first surface 106 of the perimeter of the body portion 102. In some examples, the support structure 200 may 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 may be a solid material, a solid and microporous material, a solid material with a microporous membrane attached, or made of multiple parts that are not directly attached to each other, as appropriate and as further explained herein.

[0100] For example, in Figure 2A In the embodiment, the support structure 200 covers all (or nearly all) of the perimeter to provide a more uniform reinforcement effect to the main body portion 102 of the device, while in Figure 2B In some examples, a portion of the perimeter of the top of the first surface 106 remains exposed to provide a differential reinforcement effect to the main body portion 102, wherein one end of the main body portion 102 has a greater stiffness than the other end, and as shown, the stiffness gradually changes (i.e., decreases or increases) from one end to the other. In some examples, the catheter 104 can be attached to the support structure 200. In some examples, the support structure 200 can be made of any suitable biocompatible material that has a greater stiffness or hardness than the main body portion 102 of the device 100.

[0101] Figure 3 An example of a drainage device 100 is shown, wherein the main body portion 102 includes an inner component 300 and an outer component 302. The inner component and the outer component can be two layers of film that are bonded, integrated, fused and / or attached together using any suitable method. The term "inner" is used for an eye in which the drainage device 100 can be implanted, so that the "inner" component is proximal to the eye and the "outer" component is distal to the eye relative to the inner component. As shown, the inner component 300 has a first surface 106A and a second surface 108A, the first surface 106A having a first surface porosity, and the 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 108 has a second surface porosity greater than the first surface porosity. In some examples, the inner component 300 and the outer component 302 may be arranged such that the first surface 106A of the inner component 300 faces the first surface 106B of the outer component 302 .

[0102] In the example shown, the conduit 104 may be disposed between the first surface 106A of the inner member 300 and the first surface 106B of the outer member 302. The support structure 200 may be disposed between the inner member 300 and the outer member 302. The first surfaces 106A and 106B may have similar surface porosities relative to each other, and the second surfaces 108A and 108B may have similar surface porosities relative to each other.

[0103] For example, the body portion 102 (or, in some examples, one or more of the inner component 300 and the outer component 302 of the body portion 102) can include a biocompatible material, such as expanded polytetrafluoroethylene (ePTFE). In addition, one or more of the inner component 300 and the outer component 302 can be formed of other biocompatible materials, including biocompatible polymers that may or may not be microporous, including but not limited to polyurethanes, silicones, polysulfones, polyvinylidene fluoride (PVDF), polyhexafluoropropylene (PHFP), perfluoroalkoxy polymers (PFA), polyolefins, fluorinated ethylene propylene (FEP), acrylic copolymers, expanded polyethylene (ePE), and polytetrafluoroethylene (PTFE).

[0104] The inner member 300 and / or the outer member 302 may be in the form of one or more sheets or films, and they may include knitted, woven and / or nonwoven forms including individual strands or multiple fiber strands. In some embodiments, the inner member 300 and / or the outer member 302 may be formed from a plurality of sheets or films of polymeric material. In some embodiments, the sheets or films may be laminated or otherwise mechanically coupled together to form the inner member 300 and / or the outer member 302 and to form the body portion 102. The coupling of the sheets or films may be achieved by a variety of mechanisms, including heat treatment, high pressure compression, a bonding agent such as one or more adhesives, lamination, or other suitable methods known to those skilled in the art.

[0105] In some embodiments, adjacently positioned inner and outer components 300 and 302 and / or material layers forming such inner and outer components 300 and 302 may be partially or completely bonded via thermal methods (e.g., where one or both of the polymers forming the materials are brought to or above their melting temperatures). In some embodiments, such thermal processes facilitate the formation of an adhesive bond or cohesive (cohesive) bond between the materials or material layers. In some embodiments, adjacently positioned inner and outer components 300 and 302 and / or material layers forming such inner and outer components 300 and 302 may be partially bonded via thermal methods, where at least one material is brought to or above its melting temperature. Such thermal processes may facilitate the formation of an adhesive bond or cohesive (cohesive) bond between the materials or material layers. In some embodiments, one or more suitable adhesives are utilized and a fully bonded interface is provided. Adjacently positioned inner and outer components 300 and 302 and / or material layers forming such inner and outer components 300 and 302 may be coupled together at one or more discrete locations (such as perimeter 700) to form a stable structure extending through the resulting structure.

[0106] In some examples, the tube or conduit 104 and / or the support structure 200 can be formed of one or more materials, including, but not limited to, PTFE, ePTFE, polyurethane, polyurethane, silicone (organopolysiloxane), polysulfone, PVDF, PHFP, PFA, polyolefins, FEP, ethylene fluorinated ethylene-propylene (EFEP), ethylene-tetrafluoroethylene (ETFE), and acrylic copolymers, etc. In some embodiments, the material can include other biocompatible polymers suitable for forming the conduit 104 and / or the support structure 200, including, but not limited to, silicon-urethane copolymers, styrene / isobutylene copolymers, polyisobutylene, polyethylene-co-poly(vinyl acetate), polyester copolymers, nylon copolymers, fluorinated hydrocarbon polymers, and any copolymers or mixtures of the above that may be used. In various embodiments, the elastomer or elastomeric material may include perfluoromethyl vinyl ether and tetrafluoroethylene, (per)fluoroalkyl vinyl ether (PAVE), copolymers of tetrafluoroethylene and perfluoromethyl vinyl ether, silicone (silicone resin), 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, mainly including but not limited to acrylic and its copolymers, polyester and its copolymers, polypropylene, polystyrene, nylon and its copolymers, PTFE, etc.

[0107] exist Figure 4, an example of the device 100 is shown, wherein the inner component 300 and the support structure 200 at least partially overlap each other. The inner component 300 can be shaped like a gasket or a flat ring, so that the center of the inner component 300 forms an opening, and the fluid can leave through the opening after flowing out of the conduit 104. Similarly, the support structure 200 can be similar to such a gasket, but also includes an opening on its perimeter to allow the conduit 104 to be inserted through the opening as shown in the figure, so that the conduit 104 can be set and fixed in place, 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 the same direction as shown in the figure. The support structure 200 can be a part of 300 and 302, which is heat treated or sintered to weld or attach the two 300 and 302 together.

[0108] exist Figure 5 , an example of an apparatus 100 is shown in which a plurality of support structure components 200A, 200B, and 200C are implemented. Although three support structure components are shown, there may be four or more components, or there may be two components (e.g., Figure 6 100B and 100C, and the support structure component 200A may be arranged so that one or more channels 500 are formed between the support structure component 200A and the other support structure components 200B and 200C. In some examples, the support structure component is arranged between the first surface 106A of the inner component 300 and the first surface 106B of the outer component 302, for example, to attach the first surface 106A to the first surface 106B.

[0109] In some examples, the fluid may flow out of the channel 500, which may be defined by the support structure components 200A, 200B, and 200C and the inner component 300 and the outer component 302 of the main body portion 102. In some examples, the support structure components 200A, 200B, or 200C may have a shape similar to an arch or a semicircle, a quarter circle, or any other suitable configuration, depending on how many support structure components there are. In some examples, when there are many smaller support structure components (e.g., ten support structure components), each support structure component may be formed into a square or rectangular shape and arranged on the perimeter of the main body portion 102 so that multiple channels are formed therebetween. In some examples, each component of the support structure 200 may be made of a thermoplastic material.

[0110] Figure 6An example of the device 100 is shown in which the support structure 200 has two support structure components 200A and 200B, wherein the catheter 104 is attached to the component 200B. In this example, the main body portion 102 has a single component, so there is no Figure 5 In contrast, the channel 500 is defined by the body portion 102 (or more specifically, the first surface 106 of the body portion 102) and the support structure components 200A and 200B.

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

[0112] Figures 8A to 8C An example of device 100 is shown 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 at least 50%, at least 60%, at least 70%, at least 80% of body portion 102, or any other suitable range, combination of ranges, or value therebetween.

[0113] Figures 9A to 9C An example of the device 100 is shown in which the catheter 104 is attached to the perimeter 700 of the first surface 106 of the body portion 102 using an adhesive 704 between the catheter 104 and the body portion 102, and the anti-corrosion element 702 extends outwardly from the perimeter 700 of the body portion 102 relative to the position of the adhesive 704. The anti-corrosion element 702 remains unattached to the catheter 104 and is free to move relative to the catheter 104.

[0114] Figures 10A to 10CAn example of a device 100 is shown in which an anti-corrosion element 702 extends outwardly from a perimeter 700 of the body portion 102 relative to the position of an adhesive 704, and a conduit 104 is attached to a first surface 106 of the body portion 102 using an adhesive 704 extending across at least 50% of the cross-sectional length of the body portion 102. In some examples, the conduit 104 may be attached to at least 50%, at least 60%, at least 70%, at least 80%, or any other suitable range, combination of ranges, or value therebetween. The anti-corrosion element 702 remains unattached to the conduit 104. In some examples, the anti-corrosion element 702 may be a separate component from the body portion 102, and the anti-corrosion element 702 may be temporarily or permanently fixed, attached, or adhered to the body portion 102. In some examples, the anti-corrosion element 702 may be a continuous extension of the body portion 102.

[0115] Figures 11A to 11G An example of a device 100 is shown in which the support structure 200 is disposed between the inner component 300 and the outer component 302 of the body portion 102. The adhesive 704 is disposed at the attachment area 1100, which can extend a length (e.g., Fig.11D ) or extends a length along a portion of the corrosion resistant element 702 (as shown Fig.11E and 11G In some examples, the attachment region 1100 may extend in two directions, namely, simultaneously along the perimeter 700 and along a portion of the corrosion resistant element 702 .

[0116] When the attachment area 1100 extends along a portion of the corrosion resistant element 702, the corrosion resistant element 702 is divided into two parts: a first corrosion resistant element part 702A and a second corrosion resistant element part 702B located on both sides of the attachment area 1100. Therefore, the corrosion resistant element 702 can be partially attached to the conduit 104, and the first part 702A and the second part 702B of the corrosion resistant element 702 remain unattached to the conduit 104. Therefore, these parts 702A and 702B can move freely relative to the conduit 104.

[0117] Figures 12A to 12CAn example of a device 100 is shown, wherein in addition to the body portion 102 having the inner component 300 and the outer component 302, the body portion 102 also includes one or more additional inner components 1200, each additional inner component 1200 having a first surface 106C and a second surface 108C, the first surface 106C having a first surface porosity, and the second surface 108C having a second surface porosity greater than the first surface porosity. The additional inner components 1200 are attached to the outer component 302 so that each first surface 106C of the additional inner components 1200 faces the first surface 106B of the outer component 302. Therefore, 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 a single additional internal component. In some examples, there may be two or more additional internal components. In the example shown, the device 100 includes two additional internal components 1200A and 1200B, and the support structure components 200A, 200B, and 200C are arranged so that the support structure component 200A is arranged between the internal component 300 and the external component 302 of the main body portion 102, the support structure component 200B is arranged between the additional internal component 1200A and the external component 302 of the main body portion 102, and the support structure component 200C is arranged between the additional internal component 1200B and the external component 302 of the main body portion 102. As shown, the support structure components 200B and 200C can be used to attach the first surface 106C of the additional internal components 1200A and 1200B to the first surface 106B of the external component 302 of the main body portion 102, respectively. In some examples, each of the support structure components 200A, 200B, and 200C may be made of a thermoplastic material.

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

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

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

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

[0123] In some such embodiments, the conduit 104 of the device 100 can be isolated from surrounding tissue of the eye (e.g., sclera or conjunctiva) by including multiple corrosion resistant elements (e.g., 702A and 702B). In other words, in some embodiments, the device 100 can include one or more corrosion resistant elements 702 that isolate the conduit 104 from tissue of the eye. For example, the device 100 can be configured such that the corrosion resistant elements 702 are located on either side of the plane that bisects (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 corrosion resistant elements 702 can extend along the conduit 104 between the fluid conduit 104 and the sclera of the eye. Similarly, a second one of the corrosion resistant elements 702 can extend along the conduit 104 between the conduit 104 and the conjunctiva of the eye. This configuration provides corrosion protection to 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) because the fluid conduit 104 is prevented from directly interfacing with the conjunctiva and sclera.

[0124] In various embodiments, the anti-corrosion element 702 comprises a thin, flexible porous membrane consistent in construction, form, and composition with various other thin, flexible porous membranes discussed herein. For example, the anti-corrosion element 702 may include a microstructure configured to resist tissue ingrowth (e.g., surface 106), or may alternatively include a microstructure configured to promote or allow tissue ingrowth (e.g., surface 108, such as in Figure 1B Alternatively, in some embodiments, the corrosion resistant element 702 may include a structure (which may be monolayer or multilayer) that includes a first surface (or region on a surface) configured to promote or allow tissue ingrowth (e.g., Figure 1B region 118 as shown) and a second surface (or region on a surface) configured to resist tissue or cell ingrowth (e.g., as Figure 1B Surface 106 shown). In such embodiments, when the device 100 is implanted in the eye, the (one or more) permissive / resistant layers or regions are oriented to optimize their effect. For example, as discussed in more detail below, in various embodiments, the anti-corrosion element 702 is configured to promote or allow tissue in-growth along the interface between the anti-corrosion element 702 and tissue of the eye (e.g., sclera or conjunctiva). Therefore, it will be understood that the material of the anti-corrosion element 702 can include any material and can be configured according to any method discussed herein to be suitable for the layer or region in question.

[0125] Thus, in various embodiments, the anti-corrosion element 702 can be coupled to (or alternatively, can be an extension of or integral with) any component of the body part 102 discussed herein. Thus, in some embodiments, the anti-corrosion element 702 itself can be a membrane or construction having a porosity configured to minimize, resist, or prevent tissue ingrowth, or a membrane or construction configured to allow tissue ingrowth.

[0126] In some examples, as shown, the corrosion resistant element 702 extends away from the main body portion 102 of the device 100. In some embodiments, the corrosion resistant element 702 extends along the fluid conduit 104 away from the outer member 302 of the main body portion 102, between the conduit 104 and the inner member 300 of the main body portion 102. In some embodiments, the corrosion resistant element 702 extends between the inner member 300 of the main body portion 102 and an end of the fluid conduit 104 (e.g., a first end or a second end of the fluid conduit 104), which, as will be appreciated by those skilled in the art, is primarily configured to enter a body cavity filled with biological fluids, such as the anterior chamber of an eye, compared to other embodiments.

[0127] Although the corrosion protection element 702 is Figures 9A to 9C , Figures 10A to 10C , Figures 11A to 11G , Figures 12A to 12C , Figures 13A to 13C and Figures 14A to 14C , it will be appreciated that the anti-corrosion element 702 may have any suitable shape without departing from the spirit or scope of the present disclosure. For example, the anti-corrosion element 702 may be square, rectangular, trapezoidal, or some other polygonal shape, and may include chamfered or rounded edges between the edges (sides), and the edges may be linear or generally curved in nature. The anti-corrosion element 702 may have generally continuous curved edges, so that it is circular or oval, or have other suitable shapes (e.g., bean-shaped). It should be appreciated that those skilled in the art will appreciate that the anti-corrosion element 702 may have any desired shape as long as the anti-corrosion element 702 helps prevent corrosion of the tissue surrounding the fluid conduit through the fluid conduit, as described herein, and as long as the anti-corrosion element 702 can be placed in a subconjunctival space (such as a pocket formed between the conjunctiva and the sclera).

[0128] In some embodiments, the anti-corrosion element 702 extends along the length of the fluid conduit, but includes a length that is shorter than the length of the portion of the fluid conduit extending from the main body portion 102. In other embodiments, the anti-corrosion element 702 extends along the length of the fluid conduit and includes a length that is equal to or greater than the length of the portion of the fluid conduit extending from the main body portion 102. In some embodiments, the width of the anti-corrosion element 702 is greater than or equal to the diameter of the fluid conduit 104. However, in some embodiments, the width of the anti-corrosion element 702 may be less than the diameter of the fluid conduit, as long as the anti-corrosion element 702 is not ineffective in helping to prevent corrosion of the fluid conduit through surrounding tissue. Consistent with the versatility of suitable sizes and shapes of the anti-corrosion element 702 discussed above, it should be understood that the width of the anti-corrosion element 702 may remain constant along the length of the anti-corrosion element 702, or alternatively, the width of the anti-corrosion element 702 may vary along the length of the anti-corrosion element 702. For example, the width of the anti-corrosion element may taper (linearly or non-linearly) along the longitudinal length of the anti-corrosion element.

[0129] In some embodiments, the corrosion resistant element 702 may be configured so that it is more wear resistant in high wear or high abrasion areas (regions) (e.g., areas / regions where the fluid conduit 104 may move relative to the corrosion resistant element 702). Wear resistance in these areas may be achieved according to any known method, including material composition and / or material thickness. Therefore, the thickness of the corrosion resistant element 702 may vary along the length of the corrosion resistant element 702, and / or may vary laterally across its width. For example, the thickness may taper (linearly or non-linearly) along the length of the corrosion resistant element 702 and / or laterally across the length of the corrosion resistant element 702. For example, the thickness of the corrosion resistant element 702 along the centerline extending longitudinally may exceed the thickness of one or more of the edges of the corrosion resistant element 702 extending longitudinally. Alternatively, it will be understood that the thickness of the corrosion resistant element 702 along the centerline extending longitudinally may be less than the thickness of one or more of the edges of the corrosion resistant element 702 extending longitudinally. Additionally or alternatively, the thickness of the corrosion resistant element 702 along a portion of its longitudinal length may exceed the thickness of the corrosion resistant element 702 along a second portion of its longitudinal length. For example, if the area where the fluid conduit 104 enters a fluid-filled body cavity corresponds to a high-abrasion area, a section of the corrosion resistant element 702 that is more proximal to (closer to) the end of the fluid conduit 104 configured to enter a fluid-filled body cavity may be thicker than a section of the corrosion resistant element 702 that is more proximal to (closer to) the body portion 102. It should be understood that the thickness of the corrosion resistant element 702 may be optimized in high-wear or high-abrasion areas to reduce the risk of premature failure of the device 100 due to abrasion of the corrosion resistant element 702 by the fluid conduit 104. These variations in thickness may be achieved by selective layering of materials that together form the corrosion resistant element 702 or other known methods.

[0130] In some embodiments, the corrosion resistant element 702 may be longitudinally spaced apart from the main body portion 102, or may include a region of reduced width (not shown) and / or a region of reduced thickness (not shown) that extends between the corrosion resistant element 702 and the main body portion 102 along an area of ​​the fluid conduit 104 associated with a low risk of corrosion through the surrounding tissue. For example, if a portion of the fluid conduit 104 adjacent to the main body portion 102 is associated with a low risk of corrosion through the surrounding tissue, the region of reduced width and / or thickness of the corrosion resistant element 702 may be positioned adjacent to the region of the fluid conduit 104. Alternatively, the corrosion resistant element 702 may be configured such that the fluid conduit 104 is exposed to the surrounding tissue in the region of low risk of corrosion. Thus, in some examples, the corrosion resistant element 702 may not extend from the main body portion 102.

[0131] In some embodiments, the corrosion resistant element 702 is coupled to the fluid conduit 104. The corrosion resistant element 702 may be coupled to the fluid conduit 104 continuously along the length of the fluid conduit 104, or alternatively at one or more discrete locations along the fluid conduit 104. The corrosion resistant element 702 may be coupled to the fluid conduit 104 according to any known method, including but not limited to sewing or stitching the corrosion resistant element along the length of the conduit. In some embodiments, the stitching may be a series of interrupted stitches or a continuous (running) stitch. Additionally or alternatively, the fluid conduit 104 may be mechanically adhered to the corrosion resistant element 702 by partially melting the fluid conduit 104 into the microporous structure of the corrosion resistant element 702. In some embodiments, the corrosion resistant element 702 may be coated with a viscous adhesive so that the fluid conduit 104 can be releasably bonded to the corrosion resistant element 702. In some embodiments, one or more strips of material (e.g., microporous material) may have their ends adhered to the corrosion resistant element 702 so that an eyelet is formed between the strip of material and the corrosion resistant element 702, and the fluid conduit 104 may be passed through the gap. In some examples, such as Fig.11D As shown, the physician can trim (e.g., by cutting) the trimmable portion 703 of the corrosion resistant element 702 to adjust the length or area of ​​the corrosion resistant element 702 by removing (one or more) portions that are not needed in the procedure. Fig.11E As shown, there may be multiple trimmable portions 703A and 703B, such as when there are multiple corrosion resistant elements (eg, 702A and 702B as shown).

[0132] Figures 14A to 14B An example of a device 100 is shown in which the body portion 102 includes one or more third surfaces 1400. The third surface 1400 can be defined as an area in the second surface 108 (in the example shown, it corresponds to the second surface 108B of the outer part 302 of the body portion 102) that is opposite the first surface 106 (in the example shown, it corresponds to the first surface 106B of the outer part 302 of the body portion 102). The third surface 1400 is discontinuous with the second surface 108 and has a third porosity that is less than the second porosity of the second surface 108, similar to the low porosity area 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] In some examples, the third surface 1400 may be a depression formed on the second surface 108, such as Fig. 14C, where the recess is formed by removing a portion of body portion 102 having a second (higher) porosity (or, in the example shown, a portion of outer component 302 of body portion 102). According to some examples, third surface 1400 may be a recess formed by applying pressure to reduce the thickness of body portion 102 (or, in the example shown, outer component 302 of body portion 102).

[0134] In the example shown, there are three third surfaces 1400A, 1400B, and 1400C and two additional internal components 1200A and 1200B. Therefore, the positions of these third surfaces and additional internal components can be determined so that each third surface 1400 can be located on the side of the external component 302 of the main body portion 102 opposite to one of the additional internal components 1200 (for example, the third surface 1400A can be paired with the additional internal component 1200A, and the third surface 1400B can be paired with the additional internal component 1200B). In some examples, there can be a third surface that is not paired with any additional internal component, such as the third surface 1400C.

[0135] Advantages of implementing the drainage device embodiments disclosed herein include allowing for the formation of a significantly thinner conjunctival sac relative to the solid silicone sheet "tube shunt" prior art devices known in the art for the Ahmed Glaucoma Valve (e.g., see the prior art examples shown in Figures 15A to 15C), and implementing the open collapsible body portion disclosed herein helps to relieve the stress applied by the device to the conjunctiva when implanted, thereby minimizing the stress that the eye may experience when subjected to pressure from the AC. Thinness can provide advantages including, but not limited to, requiring less material to produce, having a simpler design to manufacture and modify, having a lighter weight, a smaller profile, being minimally invasive when implanted, and increasing the life of the device because the absence of any chambers or reservoirs ensures that the device will not fill with cells and cellular debris after prolonged use.

[0136] In addition, the surface area of ​​the device is limited by the interior of the main body part with sufficient microporosity, and the water flow (fluid flow) is carried out through this surface area. In addition, an outer surface of the device can have a sufficiently large microporosity to promote tissue ingrowth, but the opposite outer surface of the main body part can have a sufficiently small microporosity to prevent tissue ingrowth from reaching the opposite outer surface, thereby allowing a suitable amount of tissue ingrowth to occur on one surface of the device, while reducing the problem of excessive tissue ingrowth on both surfaces of the device, and allowing fluid to flow from one surface (e.g., from the eye) to another surface (e.g., into the conjunctiva). In addition, as described herein, by positioning the catheter on the scleral side of the main body part, the catheter (tube) is protected from the influence of the conjunctiva. This protection may be beneficial, for example, to reduce the risk of the catheter being blocked at the distal end (conjunctiva) of the device. In addition, (one or more) reinforcing elements such as support structures (or its components) positioned at the periphery of the device can help practitioners (e.g., doctors, surgeons or physicians) operate the device for implantation while minimizing the risk of practitioners accidentally folding the main body part of the device in vivo, which may have a negative impact on the efficacy of the device or make the device ineffective.

[0137] Various modifications and additions may be made to the exemplary embodiments discussed without departing from the scope of the present disclosure. For example, although the embodiments described above relate to specific 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. Therefore, the scope of the present disclosure is intended to cover all such substitutions, modifications and variations that fall within the scope of the claims, and all their equivalents.

Claims

1. A drainage device for draining biological fluid from an eye to tissue outside the eye, the drainage device being implantable at least partially within tissue of the eye and comprising: an open collapsible body portion having a first surface and a second surface, the first surface having a first porosity and the second surface having a second porosity greater than the first porosity, the second surface being opposite the first surface; as well as a catheter having a first end and a second end, the first end being fluidly coupled to the first surface and the second end being insertable into the eye to facilitate drainage of biological fluid into the catheter, Wherein the second surface having the second porosity comprises at least one ingrowth surface region for promoting ingrowth of tissue outside the eye.

2. The drainage device according to claim 1, characterized in that: The first surface having the first porosity is configured to inhibit ingrowth of tissue external to the eye.

3. The drainage device according to claim 1 or 2, characterized in that: The second surface also includes at least one low porosity region for inhibiting ingrowth of tissue external to the eye.

4. The drainage device according to claim 3, characterized in that: The at least one low-porosity region in the second surface defines a third surface opposite the first surface, the third surface being discontinuous with the second surface and having a third porosity less than the second porosity.

5. The drainage device according to claim 4, characterized in that: The third porosity is equal to the first porosity.

6. A drainage device according to any one of the preceding claims, characterized in that The body portion includes a plurality of interior regions having a porosity greater than the first porosity and less than the second porosity.

7. A drainage device according to any one of the preceding claims, characterized in that The conduit is attached to the perimeter of the body portion.

8. The drainage device according to any one of claims 1 to 6, characterized in that: The conduit is attached to the body portion across at least 50% of the cross-sectional length of the body portion.

9. The drainage device according to any one of claims 1 to 6, characterized in that: The conduit is attached to the first surface of the body portion at an attachment area, and the body portion further includes a corrosion resistant element having a trimmable portion extending outwardly from the attachment area relative to the conduit.

10. The drainage device according to claim 9, characterized in that The corrosion protection element is a separate component from the main body portion.

11. The drainage device according to claim 9, characterized in that: The corrosion protection element is a continuous extension of the body portion.

12. A drainage device according to any one of the preceding claims, characterized in that The main body includes: an internal component having a first surface and a second surface, the first surface of the internal component having a first surface porosity, and the second surface of the internal component having a second surface porosity greater than the first surface porosity, and an outer component having a first surface and a second surface, the first surface of the outer component having a first surface porosity, and the second surface of the outer component having a second surface porosity greater than the first surface porosity, The inner component and the outer component are arranged such that a first surface of the inner component faces a first surface of the outer component.

13. The drainage device according to claim 12, characterized in that The conduit is disposed between a first surface of the inner member and a first surface of the outer member.

14. The drainage device according to claim 12 or 13, characterized in that: Also includes: one or more additional internal components, each additional internal component having a first surface and a second surface, the first surface having a first surface porosity and the second surface having a second surface porosity greater than the first surface porosity, Wherein, the additional inner components are attached to the outer component such that a first surface of each of the additional inner components faces the first surface of the outer component.

15. A drainage device according to any one of the preceding claims, characterized in that Also included is a support structure attached to at least a portion of the body portion.

16. The drainage device according to claim 15, characterized in that The conduit is attached to a portion of the support structure.

17. The drainage device according to claim 15 or 16, characterized in that: The support structure includes one or more thermoplastic components.

18. The drainage device according to claim 17, characterized in that One or more channels are formed between the two thermoplastic components, and biological fluids are configured to pass through the channels.

19. A drainage device as claimed in any one of claims 15 to 18 and further according to claim 12, characterized in that 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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