Implantable device for deep sclerectomy

Abstract

A scleral space implant for implantation into a scleral space includes a unitary porous base having a top surface and an opposing bottom surface defining an implant interior and a uniform implant thickness uniformly disposed between the opposing top and bottom surfaces. The base has an implant rigidity that maintains the implant thickness when the scleral space implant is disposed in the scleral space. The top and bottom surfaces of the base each have an anti-tissue pore structure that inhibits ingrown tissue from entering the implant interior while allowing aqueous humor to flow into the implant interior. The implant interior has a coupling pore structure that facilitates the flow of aqueous humor through the implant interior.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Patent Application No. 63 / 568,790, filed March 22, 2024, the entire disclosure of which is incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to implantable devices. More specifically, this disclosure relates to medical devices for deep scleral resection. Background Technology

[0004] Glaucoma is a group of diseases often characterized by elevated intraocular pressure (IOP). Glaucoma affects the optic nerve and can lead to blindness if left untreated. Glaucoma patients may require surgical intervention to preserve their vision. When glaucoma continues to progress despite medication and possible laser treatments, glaucoma filtration procedures (trabeculectomy) can be recommended. Additional surgical techniques for lowering IOP include laser trabeculoplasty, non-penetrating filtration surgery, shunts, and ciliary body destructive procedures.

[0005] Deep scleretomy (DS) is a non-penetrating filtration procedure used to treat open-angle glaucoma that is uncontrolled by medication, and it carries a lower risk of complications compared to trabeculectomy. In DS, the surgeon procedurally removes a sheet of deep sclera, tops the Schlemm's canal, and removes the underlying trabecular meshwork, creating a scleral space through which aqueous humor drains. By removing the trabecular meshwork, non-penetrating DS effectively targets the site of greatest outflow resistance, thereby increasing aqueous humor outflow and reducing ingress-op (IOP). Because it does not penetrate the anterior chamber through the full thickness of the trabecular meshwork, non-penetrating DS offers greater reliability and safety than trabeculectomy.

[0006] However, non-penetrating DS has proven to be a technically challenging procedure with a long learning curve and a high conversion rate to trabeculectomy, particularly in the hands of inexperienced surgeons. In some cases, collagen implants (such as AquaFlow® (STAAR Surgical)) are implanted into the scleral space formed during the DS procedure, as explained above. The collagen implant can act as a scaffold to allow fluid flow to a reservoir hidden beneath the ocular surface, behind the scleral flap, which now acts as a cover. The collagen implant then dissolves after creating new pathways for excess IOP. However, due to the nature of collagen implants, dissolution can inhibit fluid flow through the new pathways over time due to blockages in the pathways caused by inward tissue growth. Therefore, there is a need for implantable medical devices designed to maintain pathways to continuously allow fluid flow from the anterior chamber in order to maintain IOP within preferred ranges over extended periods. Summary of the Invention

[0007] In Example 1, a scleral space implant is provided for implantation into a scleral space created during a deep scleralectomy procedure performed on a human eye. The deep scleralectomy procedure involves removing ocular tissue to define a scleral space between a superficial scleral flap and the inner wall of the Schlemm's canal of the eye, the inner wall of the Schlemm's canal defining the inflow of aqueous humor into the scleral space. The scleral space implant includes a single porous substrate having a top surface and an opposing bottom surface defining an implant interior and a uniform implant thickness uniformly disposed between the opposing top and bottom surfaces. The substrate also has implant rigidity that maintains the implant thickness when the scleral space implant is disposed in the scleral space. The top and bottom surfaces of the substrate each have tissue-inhibiting pore structures that inhibit inward growth of tissue into the implant interior while allowing aqueous humor inflow into the implant interior. The implant interior also has connecting pore structures that facilitate aqueous humor inflow through the implant interior.

[0008] In Example 2, the implant of Example 1, wherein the single porous substrate further includes at least one external region having a pore structure that allows inward growth of tissue into the at least one external region.

[0009] In Example 3, the implant of Example 2 is used, wherein a single porous substrate has an open-tight-open-tight-open configuration.

[0010] In Example 4, an implant of at least one of Examples 1 to 3, wherein a top surface and a bottom surface each define an outer peripheral edge, the outer peripheral edges cooperating to completely enclose the interior of the implant in at least one cross-sectional plane passing through the implant.

[0011] In Example 5, an implant of at least one of Examples 1 to 4, wherein a single porous base is trimmable to define an implant profile conforming to the scleral space.

[0012] In Example 6, the implant of Example 5 is used, wherein the implant is positioned entirely beneath the superficial scleral flap after being trimmed and implanted.

[0013] In Example 7, an implant of at least one of Examples 1 to 6, wherein the top surface defines a scleral flap plane for receiving and maintaining the superficial scleral flap in a planar orientation.

[0014] In Example 8, an implant of at least one of Examples 1 to 7, wherein a channel extends from the bottom surface of the inner wall of an adjacent Schlemm tube, passes through the interior of the implant to reach an outflow surface of the implant that facilitates the removal of aqueous humor from the scleral space.

[0015] In Example 9, an implant of at least one of Examples 1 to 8, wherein a single porous base includes a tail portion extending from the scleral space.

[0016] In Example 10, the implant of Example 9 is used, wherein the outflow surface is located at the tail portion.

[0017] In Example 11, the implant of Example 10 has a tail portion that is trimmable to be flush with the outer surface of the superficial scleral flap.

[0018] In Example 12, an implant of at least one of Examples 1 to 11, wherein the single porous substrate comprises polyethylene (PE), expanded polyethylene (ePE), expanded polytetrafluoroethylene (ePTFE), or silicone.

[0019] In Example 13, the implant of at least one of Examples 1 to 12, wherein the deep scleral excision procedure does not involve the use of antimetabolites.

[0020] In Example 14, an implant of at least one of Examples 1 to 13, wherein the bottom surface includes a Schlem tube junction portion configured to receive aqueous humor into the scleral space.

[0021] In Example 15, an implant of at least one of Examples 1 to 14, wherein the pore structure of the tissue-inhibiting implant includes pores having a minimum pore diameter from 0.01 µm to 1 µm.

[0022] In Example 16, an implant of at least one of Examples 1 to 15, wherein the pore structure of the tissue-inhibiting component comprises pores having an average pore diameter from 0.01 µm to 1 µm.

[0023] In Example 17, an implant of at least one of Examples 1 to 16, wherein the connection hole structure comprises PE, ePE, ePTFE or silicone.

[0024] In Example 18, an implant of at least one of Examples 1 to 17, wherein the connecting hole structure includes a first region and a second region having holes, the holes in the first region having a minimum pore diameter from 0.01µm to 1µm, and the holes in the second region having a maximum pore diameter from 1µm to 100µm.

[0025] In Example 19, an implant of at least one of Examples 1 to 18, wherein the connecting hole structure includes a first region and a second region having holes, the holes in the first region having an average pore diameter from 0.01µm to 1µm, and the holes in the second region having an average pore diameter from 1µm to 100µm.

[0026] In Example 20, an implant of at least one of Examples 1 to 19, wherein the pore structure that allows inward growth includes PE, ePE, ePTFE, or silicone.

[0027] In Example 21, an implant of at least one of Examples 1 to 20, wherein the pore structure allowing inward growth includes pores having a maximum pore diameter from 1 µm to 100 µm.

[0028] In Example 22, an implant of at least one of Examples 1 to 21, wherein the pore structure allowing inward growth comprises pores having an average pore diameter from 1 µm to 100 µm.

[0029] In Example 23, a scleral space implant is provided for implantation into a scleral space created during a deep scleral resection procedure performed on a human eye, the procedure involving the removal of ocular tissue to define a scleral space between a superficial scleral flap and the inner wall of the Schlemm's canal of the eye, the inner wall of the Schlemm's canal defining the inflow of aqueous humor into the scleral space. The scleral space implant includes a single porous substrate having a top surface and an opposing bottom surface defining an implant interior and a uniform implant thickness uniformly disposed between the opposing top and bottom surfaces. The substrate also has implant rigidity that maintains the implant thickness when the scleral space implant is disposed in the scleral space. The single porous substrate includes a tissue-inhibiting pore structure extending through a large portion of the implant thickness, the tissue-inhibiting pore structure inhibiting inwardly growing tissue from entering the implant interior while allowing aqueous humor to flow into the implant interior.

[0030] In Example 24, the implant of Example 23, wherein the pore structure of the tissue-inhibiting material includes polyethylene (PE), expanded polyethylene (ePE), expanded polytetrafluoroethylene (ePTFE), or silicone.

[0031] In Example 25, an implant of at least one of Examples 23 to 24, wherein the top and bottom surfaces have pores with a maximum aperture ranging from 1 µm to 100 µm.

[0032] In Example 26, an implant of at least one of Examples 23 to 24, wherein the top and bottom surfaces have pores with an average pore size ranging from 1 µm to 100 µm.

[0033] In Example 27, an implant of at least one of Examples 23 to 26, wherein the bottom surface includes a Schlem tube junction portion configured to receive aqueous humor into the scleral space.

[0034] In Example 28, an implant of at least one of Examples 23 to 27, wherein a single porous base is trimmable to define an implant profile conforming to the scleral space.

[0035] In Example 29, an implant of at least one of Examples 23 to 28, wherein the top surface defines a scleral flap plane for receiving and maintaining the superficial scleral flap in a planar orientation.

[0036] In Example 30, an implant of at least one of Examples 23 to 29, wherein a single porous base includes a tail portion extending from the scleral space.

[0037] In Example 31, the implant of at least one of Examples 23 to 30, wherein the deep scleral excision procedure does not involve the use of antimetabolites.

[0038] In Example 32, an implant of at least one of Examples 23 to 31, wherein the deep scleral excision procedure maintains the natural healing capacity of the tissue defining the scleral space.

[0039] In Example 33, a scleral space implant for implantation into the sclera of the eye to treat glaucoma in conjunction with a deep scleral resection procedure defining a scleral space disposed within surrounding tissue, the implant comprising: a first outer region having a first porosity that inhibits inward tissue growth and facilitates the flow of aqueous humor therethrough; a second outer region having a second porosity that inhibits inward tissue growth and facilitates the flow of aqueous humor therethrough; and an inner region disposed between the first outer region and the second outer region having a third porosity greater than the first and second porosities to facilitate fluid flow therethrough, wherein the first outer region, the second outer region, and the inner region have stiffness to resist contractile forces exerted from surrounding tissue.

[0040] In Example 34, the implant of Example 33 further includes an additional region disposed on the first outer region, such that the first outer region is disposed between the additional region and the inner region, the additional region having a fourth porosity greater than the first porosity and the second porosity.

[0041] In Example 35, an implant of any of Examples 33 to 34, wherein a portion of the first outer region, the second outer region, and the inner region defines a tail portion that extends from the remainder of the body portion defined by the first outer region, the second outer region, and the inner region, wherein the tail portion protrudes from a portion of the sclera in which the implant is inserted, such that only the body portion of the implant remains inside the sclera.

[0042] In Example 36, an implant of any of Examples 33 to 35, wherein a first outer region, a second outer region, and an inner region include a plurality of nodes and a plurality of fibrils extending between the nodes to define a pore between the fibrils.

[0043] In Example 37, the implant of any of Examples 33 to 36, wherein the first external region includes a first septum and the second external region includes a second septum, wherein the first and second septums inhibit tissue from growing inward into the internal region.

[0044] In Example 38, the implant of Example 37 includes an internal region comprising multiple support segments extending from a first spacer to a second spacer.

[0045] In Example 39, the implant of any of Examples 33 to 38, wherein the implant does not expand and is dimensionally stable when wetted.

[0046] In Example 40, an implant of any of Examples 33 to 39, wherein the implant is made of one or more biocompatible and non-biodegradable materials.

[0047] In Example 41, the implant of at least one of Examples 33 to 40, wherein the deep scleral excision procedure does not involve the use of antimetabolites.

[0048] In Example 42, a method for treating glaucoma by draining excess aqueous humor from a human eye in conjunction with a deep scleral resection procedure that defines a scleral space includes: directing inflow from the exposed inner wall of the Schlemm's canal into the interior of a scleral space implant disposed in the scleral space; inhibiting inward tissue growth from the scleral space into the implant; and guiding the inflow through the interior of the implant to an outlet communicating with the outside of the eye.

[0049] In Example 43, the method of Example 42 is used, wherein the implant includes a guided connection hole structure that facilitates inflow.

[0050] In Example 44, the method of any one of Examples 42 to 43, wherein the scleral space implant includes an outer surface having a pore structure that inhibits tissue growth into the implant.

[0051] In Example 45, the method of any of Examples 42 to 44 further includes trimming the peripheral edge of the scleral space implant to conform to the scleral space.

[0052] In Example 46, the method of any one of Examples 42 to 45 further includes supporting the superficial scleral flap in a planar orientation.

[0053] In Example 47, the method of any one of Examples 42 to 46, wherein the pore structure of the inhibited tissue includes polyethylene (PE), expanded polyethylene (ePE), expanded polytetrafluoroethylene (ePTFE), or silicone.

[0054] In Example 48, the method of any one of Examples 42 to 47, wherein the connecting hole structure comprises PE, ePE, ePTFE, or silicone.

[0055] In Example 49, the implant of at least one of Examples 42 to 48, wherein the deep scleral excision procedure does not involve the use of antimetabolites.

[0056] The foregoing examples are merely illustrative and should not be construed as limiting or otherwise narrowing the scope of any inventive concepts separately provided in this disclosure. While several examples have been disclosed, other embodiments will become apparent to those skilled in the art from the detailed implementation of the illustrative examples shown and described below. Therefore, the drawings and detailed implementation should be considered illustrative rather than restrictive. Attached Figure Description

[0057] 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. The drawings illustrate examples and, together with the specification, serve to explain the principles of the present disclosure.

[0058] Figure 1 This is a cross-sectional view of a portion of an eye in which an implantable device is implanted, according to embodiments disclosed herein.

[0059] Figure 2A This is an isometric view of an example implantable device according to embodiments disclosed herein.

[0060] Figure 2B This is an isometric view of another example of an implantable device according to embodiments disclosed herein.

[0061] Figure 2C This is an isometric view of an implantable device after trimming, according to embodiments disclosed herein.

[0062] Figure 2D This is an isometric view of another example of an implantable device according to embodiments disclosed herein.

[0063] Figure 2E This is an isometric view of another example of an implantable device according to embodiments disclosed herein.

[0064] Figure 2F This is an isometric view of another example of an implantable device according to embodiments disclosed herein.

[0065] Figure 3A and Figure 3B This is a partial cross-sectional view of the eye during a procedure for implanting an implantable device, according to embodiments disclosed herein.

[0066] Figure 4A , Figure 4B and Figure 4C This is a partial cross-sectional view of the eye during a procedure for implanting an implantable device, according to embodiments disclosed herein.

[0067] Figure 5 This is an illustration showing possible fluid flow pathways within an implantable device according to embodiments disclosed herein.

[0068] Figure 6 It is a scanning electron microscope (SEM) image of a cross-sectional view of an implantable device according to embodiments disclosed herein (the image is shown at scale).

[0069] Figure 7 It is a SEM image of the surface of an implantable device according to embodiments disclosed herein (the image is shown at the scale shown in the figure).

[0070] Figure 8 It is a SEM image of a cross-sectional view of an implantable device according to embodiments disclosed herein (the image is shown at scale).

[0071] It should be understood that, unless otherwise indicated, some of the accompanying drawings and reproductions of the photographs may not be shown to scale. In some cases, details that are not essential for understanding this disclosure or that make other details difficult to perceive may have been omitted. Of course, it should be understood that this disclosure is not necessarily limited to the specific examples or embodiments illustrated or depicted herein. Detailed Implementation

[0072] Definitions and Terms

[0073] This disclosure should not be read in a restrictive manner. For example, the terminology used herein should be read broadly in the context in which a person skilled in the art would assign meaning to such terms. It will be readily understood by a person skilled in the art that the various embodiments of the inventive concepts provided in this disclosure can be implemented by any number of methods and apparatuses configured to perform the intended function. It should also be noted that the accompanying drawings referenced herein are not necessarily drawn to scale but may be exaggerated to illustrate various aspects of this disclosure, and in this regard, the drawings should not be construed as restrictive. However, some drawings do depict anatomical structures and the positioning of embodiments relative to those anatomical structures, and such representations should be understood as scaled and accurately positioned, allowing for some deviations, as the depicted anatomical structures will vary in size and location from person to person.

[0074] Regarding the term "imprecise," the terms "approximately" and "approximately" are used interchangeably to refer to a measurement that includes the stated measurement value and also any measurement reasonably close to it. A measurement reasonably close to the stated measurement value deviates from the stated measurement value by a reasonably small amount, as understood and readily determined by a person skilled in the art. For example, such deviations can be attributed to measurement errors, differences in the calibration of measuring and / or manufacturing equipment, human error in reading and / or setting the measurement value, fine-tuning to optimize performance and / or structural parameters due to measurement differences related to other components, specific implementation scenarios, imprecise adjustments and / or manipulations of the object by humans or machines, etc. If it is determined that a person skilled in the art would not readily determine the value of such a reasonably small difference, then "approximately" and "approximately" can be understood as the value plus or minus 10%.

[0075] The phrases “at least one,” “one or more,” and “and / or” are open-ended expressions that are both operationally connective and disjoint. 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” each mean only A, only B, only C, 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-Xn, Y1-Ym, and Z1-Zo), the phrase is intended to refer to a single element selected from X, Y, and Z, a combination of elements selected from the same class (such as X1 and X2), and a combination of elements selected from two or more classes (such as Y1 and Zo).

[0076] It should be understood that every maximum numerical limit given in this disclosure is to be regarded as alternatively including every lower numerical limit, as if such lower numerical limit were explicitly stated herein. Every minimum numerical limit given in this disclosure is to be regarded as alternatively including every higher numerical limit, as if such higher numerical limit were explicitly stated herein. Every numerical range given in this disclosure is to be regarded as including every narrower numerical range falling within such a wider numerical range, as if all such narrower numerical ranges were explicitly stated herein.

[0077] Before explaining any embodiments of this disclosure in detail, it should be understood that this disclosure is not limited in its application to the construction details and component arrangements set forth in the following description or illustrated in the following drawings. This disclosure is capable of having other embodiments and can be practiced or implemented in various ways. Furthermore, it should be understood that the wording and terminology used herein are for descriptive purposes and should not be considered limiting. The use of “comprising,” “including,” or “having,” and variations thereof is intended to cover the items listed thereafter and their equivalents, as well as additional items.

[0078] Description of various embodiments

[0079] This disclosure relates to systems, apparatus, and methods for providing implantable medical devices for deep scleral resection. As disclosed herein, the implantable medical device can achieve a low inflammatory response and maintain an open fluid passage from the anterior chamber for an extended period to reduce IOP without dissolving or promoting inward tissue growth throughout the entire device.

[0080] Figure 1 This image shows a cross-sectional view of an eye 10 implantable with an implantable medical device 100 as disclosed herein, according to an example disclosed herein. Hereinafter, device 100 may be referred to as an implantable medical device or implant. The figure shows a portion of the eye 10 surrounding a Schlemm's canal 12, the outer tissue layers of the eye including a sclera 14, and anterior to the sclera 14 is a cornea 16 that allows light to enter the interior of the eye. Inner side of the eye 10 is a lens 18, which is connected to the eye via suspensory ligament fibers 20, which are connected to the ciliary body 22.

[0081] Schlemma canals 12 are vascular structures with inner walls 34 within the eye 10, and they play a role in maintaining fluid homeostasis by draining aqueous humor from the eye 10 into the systemic circulation. The ciliary muscle is composed of smooth muscle fibers or ciliary muscle fibers 24 oriented longitudinally, radially, and circumferentially. Between the lens 18 and the cornea 16 is the anterior chamber 26 containing aqueous humor. Surrounding the periphery of the lens 18 is the iris 28, which forms the pupil approximately around the center of the lens 18. Light entering the eye 10 is optically focused by the cornea 16 and the lens 18. The eye 10 also includes a trabecular meshwork 30, a fibrous tissue network surrounding the iris 28 within the eye 10. The network of tissue layers constituting the trabecular meshwork 30 is porous, thus providing a pathway for the outflow of aqueous humor from the anterior chamber 26.

[0082] In the implanted state, the device 100 occupies a surgically created space 32 in the eye 10, adjacent to the Schlem's canal 12, between the trabecular meshwork 30 and the outer layer of the sclera 14. This surgically created space 32 is also referred to as the scleral space 32 created by a non-penetrating deep scleral excision (DS) procedure, which is a surgical procedure that removes healthy scleral tissue near the Schlem's canal to create space to receive excess aqueous humor draining from the trabecular meshwork and the Schlem's canal in order to therapeutically reduce IOP. The non-penetrating DS procedure may involve removing the top tissue of the Schlem's canal 12 (referred to as "decapitation") to establish a new pathway for aqueous humor drainage. The physician performing the DS procedure anticipates stimulating a responsive healing process that may close the scleral space 32 over time. To inhibit the healing response and subsequent re-closure of the scleral space, the physician may administer antimetabolites to kill or inhibit surrounding tissue that would otherwise trigger or support the healing process. In some examples, the tissue-inhibiting (or inward-inhibiting) pore structure of the implant or device 100 disclosed herein can inhibit inward tissue refilling of the scleral space, which would allow physicians to avoid or limit the use of antimetabolites. In some examples, the DS procedure of the implant or device 100 can be modified to avoid or limit the use of antimetabolites and preserve or maintain the natural healing capacity of the tissue defining the scleral space 32.

[0083] The device 100 may have a thickness of no more than 1 mm (i.e., the distance measured from the surface facing the Schlem tube 12 to the surface facing away from the Schlem tube 12). For example... Figure 2AAs shown, the thickness is preferably uniform throughout the device 100, and in alternative designs, thickness variations may be possible to accommodate anatomical structures or physician preferences. In some examples, the thickness may be from 0.1 mm to 0.2 mm, from 0.2 mm to 0.5 mm, from 0.5 mm to 0.7 mm, from 0.7 mm to 1 mm, or any other value or combination of such ranges. In some examples, the device 100 is non-expanding upon implantation and dimensionally stable when wetted. In some examples, the device 100 is made of one or more materials that are both biocompatible and non-biodegradable. The inner wall 34 of the Schlem tube 12 defines an inflow 36A of aqueous humor into the scleral space 32, allowing aqueous humor to enter the Schlem tube 12 and then travel into the scleral space 32. It is understood that inflow 36A also indicates the location where aqueous humor enters the device 100. Then, the implant or device 100 guides aqueous humor into surrounding tissues in an outflow 36B from the device 100, whereby the outflow 36B also represents a pathway for the draining aqueous humor to leave the scleral space at a distance from the Schlemm's canal. In some examples, the outflow 36B may be referred to as an outlet 36B communicating externally with the eye 10. Figure 1 As shown, the outflow from device 100 can also originate from the side of the substrate at outflow 36C, which is similar to outflow 36B and similarly represents the pathway through which the aqueous humor in the drainage leaves the scleral space at a certain distance from the Schlemm tube.

[0084] Figures 2A to 2F Isometric views of different examples or configurations of the device 100 according to embodiments disclosed herein are shown. It should be understood that in each figure, the device 100 is shown such that the front portion of the device 100 can be substantially aligned with a plane defined by the x-axis and y-axis as shown, and the device 100 can extend generally along the z-axis, wherein the x-axis, y-axis, and z-axis are perpendicular to each other. In some examples, the positive x-direction can be defined as the direction away from the cornea 16 of the eye. In some examples, the positive y-direction can be defined as the direction toward the trabecular meshwork 30 of the eye, and / or the negative y-direction can be defined as the direction in which aqueous humor flows from the trabecular meshwork 30 into the device. In some examples, the positive z-direction can be defined as the direction extending perpendicularly from both the positive x-direction and the positive y-direction.

[0085] Figure 2A An example of device 100 is shown, wherein device 100 has a base with three (3) layers: a first outer layer 202, a second outer layer 204, and an inner layer or implant interior 200 disposed between the outer layers 202 and 204. It will be understood that these layers can be as follows: Figure 2A and Figure 2BThe diagram shows clear boundaries between adjacent layers, or alternatively includes irregular or undefined boundaries. Alternatively, the boundaries between adjacent layers may merge with each other, or provide a gradual transition from one layer to the next. It can also be further understood that the substrate can be formed by joining multiple discrete layers, each with unique properties, or, in a preferred embodiment, by a material having properties that vary within the material, and, in a more preferred embodiment, by a material having properties that vary between the outer surfaces of the material. The device 100 can present a sufficiently planar configuration when positioned on a flat surface before implantation. Figure 2B An alternative embodiment is shown, wherein the device 100 has an additional layer 206 disposed outside the first outer layer 202, such that the first outer layer 202 is disposed between the additional layer 206 and the inner layer 200. Figure 2B In some examples not shown, the additional layer 206 may alternatively be disposed outside the second outer layer 204, such that the second outer layer 204 is disposed between the additional layer 206 and the inner layer 200, or it may be configured as a second additional layer 206, such that each side of the device 100 has an additional layer 206. (Refer to...) Figure 2A The first outer layer 202 defines a top surface 203, and the second outer layer 202 defines an opposing bottom surface 205. It is understood that embodiments having one or more additional layers 206 can also be referred to as outer layers and defining the top surface 203 (e.g., Figure 2B (as shown) and / or the opposite bottom surface 205.

[0086] In some examples and such Figures 2A to 2D As shown, device 100 may have a thickness "T", which is a uniform implant thickness uniformly disposed between top surface 203 and bottom surface 205, wherein device 100 has implant rigidity that maintains its thickness when the device is implanted or disposed in scleral space 32. Top surface 203 and bottom surface 205 may each have a tissue-inhibiting structure as further disclosed herein, which inhibits inward growth of tissue into inner layer 200 while allowing aqueous humor to flow into inner layer 200. Inner layer 200 may have a connecting hole structure as further disclosed herein, which facilitates aqueous humor inflow through inner layer 200 of device 100. For example, as further disclosed herein, a channel may be included between inflow 36A and outflow 36B, 36C (e.g. Figure 1(As shown) and extends through any suitable fluid pathway or channel of the inner layer 200 in the direction of aqueous humor flow. Furthermore, the additional layers 206 and 208 may have inward-growing pore structures that allow inward-growing tissue to enter one or more of the additional layers 206 presented in some embodiments. It is believed that inward-growing tissue entering the outer layer of the device can help anchor the device within the scleral space while minimizing disruption to the flow of aqueous humor into and through the inner layer.

[0087] Device 100 can be used with any suitable tool (such as a pair of surgical scissors) to trim, and as Figure 2C As shown, the device 100 may present a pinched or compressed edge along its outer periphery that could cause a reduction in the thickness of the device at the cut portion. The pinched or compressed edge may be present after the cutting and trimming device has been used with scissors, or alternatively, the pinched or compressed edge may be pre-formed in the device before the trimming process. For example, in Figure 2C In this device 100, the first side edge portion 210 and the second side edge portion 212 can be trimmed to conform to the scleral space, or reduced in thickness compared to the rest of the device 100, the thickness being measured from the outer surfaces of the first outer layer 202 and the second outer layer 204. Edge portions 210 and 212 can also be referred to as peripheral edges. For example, the top surface 203 and the bottom surface 205 can each include multiple peripheral edges 210, 212, each peripheral edge cooperating with a corresponding peripheral edge from an opposing surface. This ensures that the interior of the implant (e.g., the inner layer 200) is completely enclosed by the outer layers 202 and 204 in at least one cross-sectional plane 213 passing through the device 100. As shown, the cross-sectional plane 213 is a perpendicular cross-sectional plane intersecting the device 100 along the x and y directions, although any other suitable cross-sectional plane can be implemented. It is understood that complete closure of the basal side surfaces with the outer layers 202 and 204 can inhibit the drainage of aqueous humor from the inner layer 200 into the basal space. Figure 1 , Figure 2E and Figure 3B The lateral outflow 36C shown and described therein leaves only the outflow 36B as the path for aqueous humor to pass through the inner layer 200 and leave the implant 100 into the scleral space.

[0088] The first outer layer 202, the second outer layer 204, and the inner layer 200 possess sufficient stiffness to resist contractile forces exerted by surrounding tissues within the body when the device 100 is implanted. These contractile forces can be caused by scar tissue forming around the device 100. For example, after a non-penetrating DS procedure, collagen deposits can form inside the scleral space where the device 100 is implanted. Over time, the collagen contracts and densifies, forming aberrant deposits of dense collagen in and around the ocular portion where the implant 100 is located. It is believed that the increased density of the collagen reduces the flow of aqueous humor through the scleral space. Therefore, sufficient stiffness to resist the contractile forces exerted by such densified collagen in scar tissue is desirable, as it helps maintain consistent and reliable fluid flow over an extended period after the device 100 is implanted.

[0089] In some examples and references Figure 2A The outer layers 202 and 204 have small pores sufficient to inhibit inward tissue growth through them. For example, the characteristics of layers that promote inward tissue growth may include larger average pore sizes, such as those larger than the typical size of cells that form the potential inward-growing tissue surrounding the device when it is implanted in the scleral space, as further explained herein. Furthermore, in contrast, the outer layers 202 and 204 may prevent, inhibit, or block inward tissue growth into the inner layer 200 by having one or more regions or segments in the outer layers 202 and 204 having sufficiently small average pore sizes to inhibit significant penetration of these layers by tissue cells while maintaining the flow of fluid through them, wherein, for example, the fluid entering the inner layer 200 may include aqueous humor from the anterior chamber 26 of the eye 10. In some examples, the inclusion of the supplementary layer 206 may have a larger average pore size that promotes cell penetration to form inward tissue growth by having an average pore size larger than that of the outer layer 202 on which the supplementary layer 206 is disposed.

[0090] Figure 2D Another example of device 100 is shown, wherein device 100 has a substrate with five (5) layers: a first outer layer 202, a second outer layer 204, an inner layer 200 disposed between the outer layers 202 and 204, a first additional layer 206, and a second additional layer 208. The first additional layer 206 is disposed on the first outer layer 202 such that the first outer layer 202 is disposed between the first additional layer 206 and the inner layer 200, as per [reference to...]. Figure 2C The second additional layer 208 may be disposed on the second outer layer 204, such that the second outer layer 204 is disposed between the second additional layer 208 and the inner layer 200. The additional layers 206 and / or 208 may have an average pore size greater than the average pore size of the outer layers 202 and / or 204. Figure 2DIn this example, additional layer 206 has an average pore size that allows tissue to grow inward and defines a top surface 203, and additional layer 208 has an average pore size that allows tissue to grow inward and defines an opposing bottom surface 205. In some examples, the average pore size of additional layers 206 and 208 may be the same as the average pore size present in inner layer 200. In some examples, the structure of the additional layers may be substantially similar to the structure of inner layer 200, and may include the distribution of pores in the material, the number of pores in the material, the depth of pores in the material, or the cross-connectivity of adjacent pores within the material.

[0091] Figure 2E Another example of device 100 is shown, wherein device 100 has a single substrate 101 having a top surface 203 and an opposing bottom surface 205 defining an implant interior 200 disposed therebetween. Substrate 101 has a uniform implant thickness “T” uniformly disposed between the opposing top and bottom surfaces, and substrate 101 also has implant rigidity that maintains the implant thickness when device 100 is disposed in scleral space 32. In some examples, substrate 101 may be referred to as a monolithic substrate or a single-piece substrate because the substrate is composed of a single continuous piece of material, such that the substrate is not formed by attaching two or more pieces of material together.

[0092] Alternatively, substrate 101 may be formed of two or more discrete layers joined together to provide a single structure. In some embodiments, substrate 101 may have consistent material properties across the entire substrate, such as average pore size. It is understood that additional material properties may be consistent across the entire substrate, such as the distribution of pores in the material, the number of pores in the material, the depth of pores in the material, or the cross-connectivity of adjacent pores within the material. Figure 2E The diagram also shows multiple arrows, with solid thick arrows indicating fluid flow from the inside of device 100 to the outside (or exterior) of device 100, and dashed arrows indicating fluid flow within device 100. Within device 100, fluid can flow in any direction, generally along the xz plane defined by the x-axis and z-axis.

[0093] In some examples, the porous substrate 101 may have implant rigidity that maintains implant thickness when the device 100 or the substrate 101 is positioned in the scleral space 32, and the substrate 101 may also include a tissue-inhibiting pore structure 214 extending through a substantial portion of the thickness “T” of the substrate 101, the tissue-inhibiting pore structure 214 extending from each surface 203, 205 toward the implant interior 200 or from only a single surface of the substrate. The substantial portion of the thickness may refer to a percentage of the total thickness of a material having the selected material properties, and may be expressed as a percentage greater than 50%, and in some examples, this percentage may be at least 60%, at least 70%, at least 80%, or at least 90% of the total thickness of the substrate 101, or any other suitable range therebetween. That is, the implant interior 200 may be formed primarily of the tissue-inhibiting pore structure 214, without any additional tissue-inhibiting pores. Figure 2E The embodiment illustrates an interconnecting connection hole structure 216 (e.g., dashed arrow) that promotes aqueous humor inflow through a channel 217 within the implant 200. In such a configuration, the entire substrate 101 can be similar to... Figure 2A The outer layer 202 or 204 is shown. Alternatively, in some examples, the substrate 101 may additionally resemble... Figure 2A The outer layer 202 or 204 of the illustrated embodiment also includes a connecting hole structure 216 to facilitate aqueous humor inflow through a channel 217 within the implant interior 200, such as... Figure 2E As shown, the substrate 101 has two regions or segments (upper and lower) of both a defined top surface 203 and a bottom surface 205 with a pore structure 214 for inhibiting tissue, while a connecting pore structure 216 is maintained between the two regions or segments of the pore structure 214 for inhibiting tissue.

[0094] Figure 2E The diagram also shows outflows 36B and 36C, illustrating how aqueous humor traveling through channel 217 can exit device 100 at its end near outflow 36B (which can be guided along the positive x-direction and / or positive / negative z-direction) or at outflow 36C on the side of the device (which can be guided along the positive / negative y-direction). Outflow 36C can be an outflow from the outer side of the device, such as an outflow from the top surface 203 and / or bottom surface 205 of device 100. It is understood that channel 217 defines the outflow from inflow 36A (in... Figure 2E (Not shown) The pathways to outflows 36B and 36C are due to the pressure gradient defined by the inflow of aqueous humor into the scleral space near the bottom surface 205, as described above.

[0095] Figure 2FAn example of device 100 is shown, wherein device 100 has a substrate with three (3) layers: a first outer layer 202, a second outer layer 204, and an inner layer or implant interior 200 disposed between the outer layers 202 and 204. In this example, the inner layer or implant interior 200 is made of a material or substrate including a porous structure that inhibits tissue growth, while the outer layers 202 and 204 are made of a material or substrate including a porous structure or a connecting porous structure that allows inward growth. Thus, the top surface 203 and the bottom surface 205 may at least partially include a porous structure or a connecting porous structure that allows inward growth.

[0096] In some examples, any part of device 100 (e.g., any one or more layers) may include one or more biocompatible materials, such as expanded polytetrafluoroethylene (ePTFE). Furthermore, one or more components of device 100 may be formed of other biocompatible materials, including biocompatible polymers that may or may not be microporous, including but not limited to polyurethane (PU), silicone, polysulfone, polyvinylidene fluoride (PVDF), polyhexafluoropropylene (PHFP), perfluoroalkoxy polymers (PFA), polyolefins, fluorinated ethylene propylene (FEP), acrylic copolymers, expanded polyethylene (ePE), and polytetrafluoroethylene (PTFE). In some examples, the material may include electrospun polyurethane.

[0097] In some examples, the materials forming the pore structures of the inhibiting tissue may include polyethylene (PE), ePE, ePTFE, and / or silicone. In some examples, the materials forming the connecting pore structures may include PE, ePE, ePTFE, and / or silicone. In some examples, the materials forming the pore structures that allow inward growth may include PE, ePE, ePTFE, and / or silicone. In some examples, certain materials (such as PE, PU, ​​polyamide-based polymers, silicone, etc.) may be used to form multiple molten structures (such as molten beads) to create pores. Such molten structures may be formed, for example, by sintering, or by any suitable method in which particles within the material are compressed or heated / chemically reacted to fuse, thereby increasing the density within the material. In some examples, doing so may facilitate maintaining channels within the structure of the material to allow fluids (such as aqueous humor) to pass through it. In some examples, the pore structures of the inhibiting tissue, the connecting pore structures, and the pore structures that allow inward growth may be formed using the same material (or a combination of materials) but processed using different methods (such as, but not limited to, sintering and electrospinning) to achieve different properties (such as average, maximum, or minimum pore size) as described herein.

[0098] Figure 3AA portion of the eye is shown during a non-penetrating DS procedure, where conjunctival tissue 302 has been partially retracted, and a portion of scleral tissue (or sclera 14) has been cut and retracted (in the direction opposite to the direction in which the conjunctival tissue 302 was retracted). The retracted portion of the scleral tissue 14 is referred to hereinafter as the "flap" 300. At this point in the DS procedure, the Schlem canal 12 has been detopped. A portion of the sclera 14 located beneath the flap 300 has been cut and removed, and the scleral space has been prepared to receive aqueous humor exiting the Schlem canal. After the scleral space has been prepared, a device 100 is shown positioned inside the scleral space to occupy the volume previously occupied by the removed tissue beneath the flap 300. Figure 3B As shown, after implantation of device 100, the DS procedure is completed when flap 300 is returned to its original position and conjunctival tissue 302 is pulled toward cornea 16, thereby covering flap 300. Therefore, device 100 is completely positioned beneath flap 300 and conjunctival tissue 302. In the implanted state, device 100 may have a second outer layer 204 facing and defining a portion of Schlemm tube 12.

[0099] In some examples, device 100 (referred to herein as a scleral space implant) is implanted in a scleral space 32 created during a DS procedure performed on a human eye 10. The DS procedure involves removing healthy ocular tissue to define a scleral space 32 between a superficial scleral flap 300 and the inner wall 34 of a Schlem tube 12 of the eye 10, also referred to as the Schlem tube inner wall 34. The Schlem tube inner wall 34 defines an inflow 36A of aqueous humor into the scleral space 32, such that aqueous humor enters the Schlem tube 12 and then into the scleral space 32, subsequently entering device 100 at inflow 36A, which enters into the bottom surface 205 of device 100. The implant or device 100 then directs the aqueous humor toward surrounding tissue via outflow 36B and, in some embodiments, via outflow 36C.

[0100] In some examples, the bottom surface 205 of the implant 100 has an engagement portion 304 for the Schlem tube 12, also referred to as the Schlem tube engagement portion 304. The engagement portion 304 is part of the bottom surface 205 defined and configured to receive the inflow 36A of aqueous humor into the scleral space 32. As explained above, since the tube has been detopped as a result of the DS procedure, the engagement portion 304 may also serve as or replace the “top” of the Schlem tube 12. The implant 100 may also be trimmable to define an implant profile 305 conforming to the scleral space 32.

[0101] In some examples, the top surface 203 of device 100 defines a scleral flap plane 306, which is configured to receive a superficial scleral flap 300 and to support or maintain the flap 300 in a planar orientation 307 similar to the original position of the flap organization prior to the DS procedure, such as... Figure 3B As shown. It is believed that the flap 300 and surrounding tissue will facilitate the outflow of aqueous humor leaving the device 100 to allow for drainage and therapeutic reduction of IOP. In some examples, the channel 217 may extend from the bottom surface 205 of the adjacent Schlemm tube inner wall 34, through the implant interior 200 to the outflow surface 308 of the implant 100 to facilitate the removal of aqueous humor from the scleral space 32.

[0102] Figure 4A Another example of device 100 is shown, wherein the tail portion 402 of device 100 protrudes from the cut portion of sclera 14, such that... Figure 4B As shown, only the body portion 400 of device 100 remains inside the cut portion and below the flap 300. In this example, the tail portion 402 will remain exposed and not covered by the flap 300 to allow aqueous humor to drain directly into the space outside the eye without passing through the repositioned scleral flap 300. The tail portion 402 also includes a portion of the outer layers 202 and 204 and a portion of the inner layer 200. In some examples, the tail portion 402 acts as a channel for fluid (e.g., aqueous humor) to enter the space between the conjunctival tissue 302 and the scleral tissue 14, thereby helping to reduce or eliminate IOP elevation due to fluid accumulation inside the anterior chamber 26. In some examples, the outflow surface 308 may be provided at the tail portion 402. In some embodiments, the outer layers 202, 204 are absent where the device extends away from the scleral space, and the drainage of aqueous humor is via a fully exposed portion of the inner layer 200 communicating with the space outside the eye.

[0103] In some examples, a portion of the top surface 203 defines a scleral flap plane 306, which is configured to receive a superficial scleral flap 300 and hold a portion of the flap 300 in a planar orientation 307. A portion of the flap 300 not held in the planar orientation 307 (i.e., a portion of the flap 300 not in contact with the portion of the top surface 203 defining the scleral flap plane 306 of the device 100) can be raised relative to the scleral flap plane 306, thereby being held in an elevation orientation 309. Both the planar orientation 307 and the elevation orientation 309 presented by the aforementioned portions of the flap 300 are... Figure 4B As shown in the image.

[0104] In other examples, the scleral flap 300 may be trimmed or positioned to prevent, inhibit, or limit the formation of the elevation orientation 309. In a further embodiment, the tail portion 402 may be shortened such that its end coincides with the planar surface defined by the scleral flap plane 306, so as to provide direct drainage of aqueous humor while presenting an uninterrupted and / or generally natural outer surface of the sclera (without aqueous humor passing through the scleral flap 300, or supplemented by aqueous humor passing through the scleral flap 300). Figure 4C An example of a device in an implanted state is shown, wherein the scleral flap 300 is trimmed to prevent, inhibit or limit the formation of the elevation orientation 309, and the tail portion 402 of the device 100 is shortened by trimming or cutting off a portion of the tail portion 402 such that the end 410 of the tail portion 402 is substantially flush with the outer surface of the scleral flap 300 and with the surface of the scleral tissue 14 of the eye.

[0105] In some embodiments, the pore structure may be defined by a material in which the pores are defined by an expanding polymer material. Figure 5 An expanded polymer material is shown, having a plurality of nodes 500 and fibrils 502, which, according to embodiments disclosed herein, may occupy space inside an interior region 200. The nodes can be any segment having a polymer “clump” or larger volume compared to the fibrils. Arrows indicate possible directions in which fluid may flow within the interior region 200 to define a connecting hole structure in which one hole communicates with one or more adjacent holes to allow fluid communication in a direction partially parallel to the outer surface of the material. Thick arrows indicate... Figure 5 The lower right corner shows the direction of potential fluid flow along the plane defined by the x and y axes, while the dashed arrows indicate directions extending beyond the page (i.e., away from the plane defined by the x and y axes) or into the page, thus indicating flow that extends at least partially along the z-axis as shown in the figure, to bypass the nodes. It can be understood that... Figure 5 The illustrated flow structure presents internal flow pathways that allow aqueous humor to migrate in multiple directions within the internal region 200. It can be further understood that the presence of a pressure gradient in the aqueous humor flow can drive the aqueous humor from the inflow position 36A of the device 100 to the outflow position 36B, and in some embodiments, to the outflow position 36C of the device 100. Additionally, it can be understood that the flow direction is biased towards the direction of least resistance, for example, given fluid transport measured or observed in vivo.

[0106] Figure 6 A microscopic view of the microporous material of an implantable device 100 according to some embodiments is shown. Figure 6The bottom displays "5.00kV 4.3mm x150 SE 8 / 7 / 2020" and a scale, as shown in the lower right corner of the image. The distance between the two continuous lines on the scale represents 30µm. For example, Figure 6 Microporous materials may be referred to throughout the text as implantable devices or systems, and embodiments are presented that provide pores and pore structures (i.e., (1) tissue-inhibiting (inward growth-inhibiting) pore structures, (2) connecting pore structures, and (3) pore structures allowing inward growth) at different locations within the same material, as further explained below. As those skilled in the art refer to Figure 6 Understandably, the microporous aspects and parameters of microporous materials can be defined in a variety of ways. In the application of microporous materials in ophthalmic devices (such as the implantable device 100 described herein), which are configured for in situ placement in the tissues of the eye to control intraocular pressure (IOP), the microporous properties of such microporous materials can typically be characterized by a volumetric porosity value, which can 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 capacity) of the microporous material.

[0107] In another definition, volumetric porosity can be defined as the percentage of a microporous material's volume occupied by non-structural or transient elements (such as air or other fluids). For example, a total volume of 100 mm². 3 And among them, 30mm 3 The volume of a microporous material, including the chambers that contain air or another fluid, will have a volume porosity value of 0.3 because 30% of the volume of the microporous material is empty or transient space filled with air or other fluid.

[0108] It is understandable that two microporous materials can have the same volumetric porosity but differ in the pore size presented to the incoming or outgoing air or fluid. For example, the first material can have a small number of large pores distributed over a fixed total volume, while the second material can have a relatively large number of relatively small pores distributed over the same fixed volume, and if the air / fluid volumes of the two materials are the same, then both microporous materials can have the same volumetric porosity.

[0109] It can be further understood that the properties of the microporous material used in the device can also be defined by the size of the channel passing through the microporous material, or similarly defined by the pore size measured at the surface where the channel terminates in 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 large pores or channels can allow air or fluid to enter, exit, or increase the passage within the microporous material.

[0110] Furthermore, the properties of microporous materials can also be defined by the tortuosity of the channels through which fluids enter and pass through the material. Relatively small or large channels present obstructed fluid pathways due to the frequency of turns within the channels or the placement of obstructions in the fluid pathways. The air / fluid throughput of microporous materials can be managed by controlling or limiting any of the aforementioned properties of the material to provide suitable materials for promoting pressure control in the eye to treat diseases.

[0111] For simplicity, the aforementioned properties and variables of the microporous materials used in the various embodiments and examples described herein can be simply presented as porosity, which can be measured based on volumetric porosity, pore or channel size, or tortuosity. See again Figure 6 The internal portion of a microporous material can have varying porosity (or volumetric porosity, or pore size, or tortuosity).

[0112] In some examples, device 100 may include two barrier or spacer regions 602 and 606 that divide device 100 into an outer portion (e.g., 202 and 204) and an inner portion (e.g., 200). The barriers or spacers may be horizontally positioned. In some examples, a first barrier or spacer region 602 may be included in a first outer region 202, and a second barrier or spacer region 606 may be included in a second outer region 204. In some examples, the first barrier or spacer 602 may define the location of an opening in the first outer region 202 due to the length and location of a node 500 extending from the first barrier or spacer 602 into the first outer region 202, and the second barrier or spacer 606 may define the location of an opening in the second outer region 204 due to the length and location of a node 500 extending from the second barrier or spacer 606 into the second outer region 204. In some examples, the inner region 200 may include a plurality of support segments 608 extending between spacers 602 and 606. Support section 608 provides resistance to external forces applied to the inner region 200 (or more generally, to the device 100 itself). In some examples, support section 608 may extend vertically from the first spacer 602 to the second spacer 606. In some examples, one of the support sections 608 may extend only partially between spacers 602 and 606, but when combined with adjacent support sections, two or more support sections 608 may extend the entire distance between spacers 602 and 606, and since the two support sections are nodes 500 interconnected via multiple fibrils 502, the two support sections can work together to provide support to the device 100 against external forces applied thereto.

[0113] At any of these parts of device 100, porosity can vary comparatively in degree between small pore size (SP), small-medium pore size (MSP), medium pore size (MP), medium-large pore size (MLP), and large pore size (LP), where LP is greater than MLP, MLP is greater than MP, MP is greater than MSP, and MSP is greater than SP. In some examples, the size of SP can be from about 0.01% to 1%, MSP can be from about 1% to 5%, MP can be from about 5% to 20%, and MLP can be from about 20% to 80% of the size of LP. The size of SP can be from about 0.01µm to about 1µm in pore diameter (or average pore size). In some examples, porosity can increase by about 5 to 10 times when the pore size increases from one category to the next (e.g., from SP to MSP or from MSP to MP, etc.).

[0114] In some embodiments, device 100 is essentially a single, monolithic component. The physical properties of barriers or partitions 602 and 606, outer portions 202 and 204, and inner portion 200 share some similarities and some differences. As previously mentioned, one similarity is that they are all fluid-permeable, meaning that aqueous humor can pass through device 100. One difference is that barriers or partitions 602 and 606 have a “tight” configuration that is cell-impermeable, while portions 200, 202, and 204 have an “open” configuration. An open configuration is cell-permeable, meaning that inward tissue growth is permitted by the open configuration of outer portions 202 and 204 but prohibited by the tight configuration of barriers or partitions 602 and 606. Furthermore, while barriers or partitions 602 and 606 allow aqueous humor to pass through, the open configuration and connecting holes of inner portion 200 facilitate the flow of aqueous humor through device 100. In other words, the flow resistance through inner portion 200 is significantly less than the flow resistance through barriers or partitions 602 and 606.

[0115] Referring to the foregoing embodiments, aqueous humor drainage can travel along a relatively straight path through the microporous material to sequentially engage the porosity of the second surface 205 of the second outer portion 204, and then enter the uniform inner portion 200. Similarly, drainage from another direction can travel through the first surface 203 of the first outer portion 202 and then enter the inner portion 200. For example, spacers 602 and 606 can have generally low porosity (e.g., to resist inward tissue growth into the inner portion 200), and portions of the inner portion (e.g., 200) and outer surfaces (e.g., 600 and 604) can have any of the aforementioned levels of porosity. In these cases, fluid can be delivered through the microporous material from a region with low porosity (small pore size SP) to a region with high porosity (large pore size LP), while simultaneously passing through a region with medium porosity (medium pore size MP), which can be represented as SP-MP-LP. Further examples are discussed below. This arrangement of pore structures and porosity can be exemplified by inward-growing pore structures at the outer portions 202 and 204, tissue-inhibiting (or inward-growing-inhibiting) pore structures at the spacers 602 and 606, and connecting pore structures at the inner portion 200. Due to the arrangement of the different regions in device 100, device 100 has a configuration referred to as “open-tight-open-tight-open” or “OTOTO”. Furthermore, in some embodiments, the outer surfaces (e.g., 600 and 604) are treated with a hydrophilic coating (such as polyvinyl alcohol (PVA)) to promote faster tissue inward growth and allow water-based liquids to be readily delivered through the outer portions 202 and 204. In such embodiments, the coating is thin and does not significantly add thickness to device 150.

[0116] Various flow paths can exist within microporous materials. For example, relatively linear flow paths can include regions SP1-SP2-SP3, or SP1-SP2-MSP1-SP3-SP4-SP5. While some flow paths can be relatively straight, nonlinear flow paths also exist. For example, under certain conditions, at least some flow can continue through regions where resistance gradually decreases, such as SP1-MLP1-MLP2-LP1 or SP7-MSP2-LP2. In some examples, under certain conditions, the flow can travel horizontally, such as MLP2-LP1-SP6. It will be understood that the microstructure of microporous materials can undergo modification processes to obtain certain types of flow through the microstructure. For example, the microstructure can have relatively uniform regions on the layers within the microstructure, or, as shown here, varied portions across the entire thickness of the microporous material. In some examples, the internal portion 200 is defined by the wall portion thickness extending between spacers 602 (defined by SP4) and 606 (defined by SP1). The wall thickness can have a transitional porosity that bridges the gap between low and high porosity.

[0117] Examples of delivery paths (alternatively referred to as flow paths or channels) are shown with white dashed arrows indicating the general direction of the delivery path, such as from either surface 203 or surface 205 into the implant interior 200, and within the interior 200, flowing substantially parallel to the length of the implant (or substantially perpendicular to the thickness of the implant). In some examples, as shown, the direction of the delivery path inside the implant interior 200 may be substantially along the direction in which the fibrils are located within the interior 200. It should be understood that in some examples, either or both of surfaces 203 and 205 may provide an inflow 36A for excess aqueous humor, such as, for example... Figure 3B and Figure 4B The fluid is directed toward the outflow surface 308 as shown.

[0118] In some examples, device 100 includes, for example: Figure 5 The diagram shows multiple nodes 500 and multiple fibrils 502. In some examples, the nodes include those described above. Figure 6 The explained segments have small pore sizes (SP), such as SP5, SP6, and SP7. Fibrous fibers can extend between segments with small pore sizes, for example, in LP2 located between SP6 and SP7. Thus, device 100 is formed by a plurality of such nodes and fibrils appropriately interconnected, interlocked, or interwoven with each other. In some examples, the nodes have different sizes and porosities, and the fibrils can define spaces or openings with larger pore sizes (LP) such that the pore size of the segment defined by the fibril is larger than the pore size of the node. In some examples, the size of the opening or space can be defined by the distance between adjacent nodes (e.g., internode distance). The pores can have a range of sizes, such as from 1 µm to 100 µm, and these pores are uniformly distributed between the solid portions. In some examples, the size (or average size) of such holes can be about 1µm to about 5µm, about 5µm to about 10µm, about 10µm to about 15µm, about 15µm to about 20µm, about 20µm to about 30µm, about 30µm to about 40µm, about 40µm to about 50µm, about 50µm to about 60µm, about 60µm to about 70µm, about 70µm to about 80µm, about 80µm to about 90µm, about 90µm to about 100µm, or any other suitable value / range or combination of ranges thereof. In some examples, the hole portion is flexible (e.g., the solid portion is made of a flexible material) to allow for hole expansion, so that the hole size can vary.

[0119] In some examples, the pore structure that inhibits tissue (or inhibits inward growth) can be defined as having a minimum or average pore size not greater than 5 µm, not greater than 4 µm, not greater than 3 µm, not greater than 2 µm, not greater than 1 µm, or any other suitable value between these values. In some examples, the minimum or average pore size can be from 0.01 µm to 0.1 µm, from 0.1 µm to 0.3 µm, from 0.3 µm to 0.5 µm, from 0.5 µm to 0.7 µm, from 0.7 µm to 1 µm, or any other suitable value between these values. For example, refer to... Figure 6 The pore structure that inhibits tissue (or inhibits inward growth) may include barriers or spacers 602 and 606, wherein barrier or spacer 602 inhibits inward growth of tissue from top surface 203 and barrier or spacer 606 inhibits inward growth of tissue from bottom surface 205.

[0120] In some examples, the permissible inward-growing pore structure can be defined as having a maximum or average pore diameter of 10 µm or greater, 20 µm or greater, 30 µm or greater, 40 µm or greater, 50 µm or greater, 100 µm or greater, or any other suitable value between these values. In some examples, the maximum or average pore diameter can be as high as 200 µm, 300 µm, 500 µm, or 700 µm. For example, refer to... Figure 6 The inward-growing pore structure may include first outer regions 202 and 204, each having outer surfaces 600 and 604 defining a top surface 203 and a bottom surface 205, respectively, and regions containing fibrils 502, designated "LP3" and "LP4". It should be understood that both the inward-growing-inhibiting and inward-growing-inhibiting pore structures provide pore sizes sufficient to facilitate fluid flow through the structure (e.g., their overall flow direction is determined by...). Figure 6 The white dashed arrows in the diagram indicate the passage of aqueous humor. In some embodiments, the holes are interconnected, such that each hole is in fluid communication with one or more adjacent holes. This configuration contrasts with blind holes that begin at the surface, extend slightly inward, and then terminate, as well as closed holes that are located inside the substrate and are completely encapsulated. Therefore, the interconnected hole structure allows fluid (e.g., aqueous humor) to flow from one hole to another through the interior 200.

[0121] In some examples, the connecting hole structure can be defined as having multiple regions with different pore diameters, such as a first region having a minimum or average pore diameter of no more than 5µm, no more than 4µm, no more than 3µm, no more than 2µm, no more than 1µm, or any other suitable value therein, and a second region having a maximum or average pore diameter of 10µm or greater, 20µm or greater, 30µm or greater, 40µm or greater, 50µm or greater, or any other suitable value therein. The first region of the connecting hole structure provides structural integrity to the device to join opposing surfaces of the device together (e.g., joining opposing pore structures that inhibit tissue formation or inward growth (e.g., barriers or spacers 602 and 606)), and the second region of the connecting hole structure provides a region with pore diameters sufficient to facilitate fluid flow through the structure (e.g., its overall flow direction is influenced by...). Figure 6 The white dashed arrow in the image indicates the passage of aqueous humor. For example, refer to... Figure 6 The first region may include the support section 608, and the second region may be the region between adjacent support sections 608, such as the region containing the fibrils 502 marked "LP1" or "LP2".

[0122] There are many different testing or measurement procedures that can be performed on the pore structure of implantable devices as disclosed herein, including but not limited to: Gurley test, Sheffield test, Bendtsen test, mercury porosimetry, gravimetric method, liquid displacement method, optical microscopy, image analysis, and visual inspection. Each of these procedures is explained herein.

[0123] The "Gerley" is a measurement of the resistance of a porous sample to airflow at a given pressure drop. The Gerley is defined as the resistance of a 100 cm³ porous sample to airflow when a constant pressure of 4.88 inches of water (0.177 psi) is applied. 3 The Graley number is the time, in seconds, that air takes to pass through one square inch of sample material. A higher Graley number indicates lower air permeability or greater resistance to airflow at a given pressure drop. The Graley number is expressed in seconds or (s / (100cm²)). 3 in 2The results are reported in units of 0.177 psi. The Gurley test measures the Gurley number of a material by measuring the time required for a given volume of air to flow through it under a constant pressure differential. The Gurley test (also known as the Gurley air permeability test) is widely used to measure the porosity of paper, fabrics, and filters. This test can be performed using any suitable flow meter, air resistance tester, and / or densitometer, such as the Model 4340 Automatic Densitometer and Smoothness Tester manufactured by Gurley Precision Instruments, Inc. (Troy, NY, USA). Examples of standard test methods for such measurements include the TAPPI T460 Gurley air resistance test or the ISO 5636-5 porosity test, as known in the art.

[0124] In some examples, permeability can be calculated using the following equation: (Equation 1) Where Q is the volume of fluid flowing through the sample over a time interval (t), η is the viscosity of the fluid, h is the thickness of the sample, F is the cross-sectional area of ​​the sample perpendicular to the fluid flow, and p is the applied pressure head. After calculating the permeability, the pore radius of the sample can be calculated using the following equation: (Equation 2) The Sheffield test measures the velocity of air through a material under different pressure differentials. It is also commonly used to measure the porosity of paper, fabrics, and filters. The test is performed by placing a sample material (the specimen) into a rubber clamping ring. Compressed air passes through a flow measurement device and is then directed to the specimen's test area. The air passing through the specimen escapes to the atmosphere through holes in a downstream clamping plate, and the airflow rate is measured to determine the specimen's permeability.

[0125] The Bentsen test measures the velocity of air flowing through a material under constant pressure differential and constant area. The Bentsen test is commonly used to measure the roughness and porosity of paper and paperboard. The Bentsen test is based on the leakage principle. The sample material or specimen is clamped between a flat glass plate and a circular metal head. Air is then forced through the sample, and the air velocity between the sample and the head is measured in mL / min. It is a commonly used testing technique with adjustable test time and water pressure. Examples of equipment that can be used to perform the Sheffield test and / or the Bentsen test include, for example, the 58-27 Bentsen tester manufactured by Büchel BV (Kappelle am IJssel, Netherlands). An example of a standard test method for such measurements is the ISO 5636-3 Bentsen method test, as is known in the art.

[0126] Mercury intrusion porosimetry (MIP) is a test or technique that measures the volume of mercury that penetrates into the pores of a material under increased pressure. MIP is commonly used to measure the porosity and pore size distribution of materials such as ceramics, metals, and composites. The MIP technique is based on the pressure-dependent intrusion of mercury as a non-wetting liquid into porous materials. Using the Washburn equation, the corresponding pore size can be calculated based on the applied pressure. Examples of equipment that can be used to perform the Sheffield test and / or Bentson test include, for example, the BELPORE porosimeter series (such as BELPORE LP, MP, and HP) manufactured by MicrotracBEL Corp (Osaka, Japan). Examples of standard test methods for such measurements include ISO 15901-1:2016 Mercury intrusion porosimetry and / or ISO 15901-2:2022 Nanopore analysis by gas adsorption, as known in the art. Minimum, maximum, and / or average pore sizes can be measured or calculated from data collected by the aforementioned techniques using known mathematical and statistical methods.

[0127] The gravimetric method uses the bulk density and true density of a porous material sample to determine its total porosity. The "bulk density" can be calculated simply by dividing the mass of the porous sample by its total volume (e.g., the total volume of the porous sample is the volume of the solid content plus the volume of the void content). The "true density" can be determined using a helium flask (or any other suitable gas flask known in the art), which measures the volume of the solid content alone in the porous sample using Boyle's Law; this volume is called the "true volume." Since the mass of the sample is known, the true density can be obtained by dividing the mass of the sample by its true volume. Using the above measures, the porosity of the sample can be calculated to define the measurement of the void content in the porous material, where the "percentage porosity" can be calculated using the following equation: (Equation 3) Where B is the bulk density of the porous material, and T is the true density of the porous material.

[0128] Liquid displacement methods involve using a displacement liquid that is not a solvent for the polymer (e.g., ethanol) of the porous material sample, allowing it to easily penetrate the pores without causing dimensional shrinkage or swelling of the material under test. The sample can be placed in a cylinder with a known volume of displacement liquid, and a series of vacuum-repressurization cycles can be performed to force the liquid into the pores as an indirect method of measuring porosity. The “open porosity” of the material can be calculated using the following equation: (Equation 4) Where V1 is the known volume of the liquid used to immerse the sample (but not the solvent of the sample material), V2 is the volume of the liquid and the sample with the immersion liquid, and V3 is the volume of the liquid remaining when the sample with the immersion liquid is removed.

[0129] Optical microscopy inspection tests or techniques use a microscope to examine materials at high magnification and identify pores or voids within them. Porosity can be estimated by counting the number of pores or by measuring the area of ​​the pores relative to the total area of ​​the material. Estimation and / or counting can be performed manually or with the aid of a computer running algorithms or software programmed to perform such tasks. In some examples, the algorithms or software may, where appropriate, implement machine learning or artificial intelligence techniques to automatically detect and identify pores.

[0130] Image analysis tests or techniques use digital images of materials (e.g., images obtained using scanning electron microscopy (SEM), micro-computed tomography (Micro-CT) imaging, or 3D models) and software programs to analyze the images and calculate porosity. Images can be obtained from various sources, such as optical microscopy, scanning electron microscopy, or computed tomography. Software can use different algorithms (such as thresholding, segmentation, or edge detection) to distinguish pores from the solid phase and measure porosity. In some examples, the software may implement machine learning or artificial intelligence techniques, as appropriate, to automatically analyze digital images.

[0131] Visual inspection tests or techniques use the naked eye or low-magnification devices to manually observe materials and estimate porosity based on their texture, color, or transparency. This method is subjective and qualitative, and may be better suited for materials with simpler or larger pores.

[0132] Figure 7 This figure shows an example of the surface of a first region of barrier or spacer 602 or a second region of barrier or spacer 604 as viewed from above. The figure also shows a microscopic view of a microporous material of a barrier or spacer according to some embodiments. Figure 7The scale shown at the bottom reads: “5.00kV 4.0mm x3.00k SE 11 / 12 / 2020”, indicating that the distance between the two continuous lines represents 1.0µm. Barriers or spacers 602 and / or 604 may have small pore sizes (SPs) or be small enough to prevent or inhibit tissue growth into them. The barrier or spacer may be formed as a single continuous node, which may be made or formed, for example, from an unexpanded or compressed material such as PE or PTFE. For example, the node may be defined by the initial state or density of the material in its unexpanded form (also referred to herein as unexpanded or compressed material, such as PE or PTFE), and fibrils may be formed by applying expansion forces to the unexpanded material in one or more directions to pull the unexpanded material apart in one or more directions, thereby defining multiple portions with a density smaller than the initial state of the material. For example, fibrils can be defined as expanded portions (e.g., portions having physical properties similar to expanded materials such as ePE or ePTFE), and nodes can be defined as unexpanded (or less expanded) portions of the material (e.g., where the unexpanded portions have physical properties similar to unexpanded or compressed materials such as PE or PTFE) compared to the expanded portions. In some examples, nodes can be defined as having a higher density and smaller pore size than the remaining portions having fibrils, and the remaining portions having fibrils can have a lower density and larger pore size compared to the nodes (where the pores can be at least partially defined by interstitial spaces located between adjacent fibrils). As shown, the surface has multiple fibrils interconnected and concentrated in a manner forming a layered structure. In the layered structure, fibrils forming the upper region can include multiple openings, and similarly, fibrils forming the lower region below the upper region can also include multiple openings. However, because the openings in each region are located in different positions, the difference in the displacement of the openings prevents, inhibits or reduces the amount of tissue growing inward from the top region all the way to the bottom region, thus keeping the bottom region essentially free of tissue growth inward, thereby providing a pore structure that inhibits tissue growth.

[0133] Using the device or implant 100 as disclosed herein, a surgeon or medical practitioner can perform drainage of excess aqueous humor from the human eye 10 to treat glaucoma in conjunction with a DS procedure that defines the scleral space 32 as disclosed herein. In some examples, the drainage involves directing the inflow 36A from the exposed inner wall 34 of Schlemm's canal into the interior 200 of the scleral space implant 100 disposed in the scleral space. In some examples, the drainage further involves inhibiting inward tissue growth from the scleral space 32 surrounding the implant 100 into the implant interior 200. Thereafter, in some examples, the drainage involves directing the inflow of fluid (excess aqueous humor) through the implant interior 200 toward the outflow or outlets 36B, 36C that communicate with the exterior of the eye 10. In some examples, the path of fluid within implant 100 (or alternatively referred to as a flow path or channel) may be located as Figure 1 , Figure 2E , Figure 3B , Figure 4B , Figure 5 and / or Figure 6 along any one or more of the lines indicated by the arrows shown. In some examples, the outer peripheral edge of the scleral space implant may be trimmed to conform to the scleral space. In some examples, the superficial scleral flap can be supported in a planar orientation.

[0134] Figure 8 is an SEM image of a cross-sectional view of an implantable device according to embodiments disclosed herein. Figure 8 The scale bar shown at the bottom is: "5.00kV 10.9mm x300 SE 3 / 5 / 2024", showing that the distance between two consecutive lines represents 10µm. With Figure 2FSimilar to the embodiment shown, the SEM image illustrates a substrate with three (3) regions: a first outer region 202, a second outer region 204, and an inner region 200 disposed between the outer regions 202 and 204. The inner region, or implant interior 200, is constructed of a material or substrate comprising a porous structure that inhibits tissue growth (which may be a single, continuous node 500 with additional nodes extending from each side, as shown). The outer regions 202 and 204 are constructed of a material or substrate comprising a porous structure that allows inward growth (which may include an interconnection network of nodes 500 and fibrils 502, wherein fibrils 502 extend between adjacent nodes 500). In some examples, fibrils and nodes may be formed using the same material. Thus, the top surface 203 and the bottom surface 205 may at least partially comprise a porous structure that allows inward growth, wherein the pores are at least partially defined by the spacing (e.g., gap space) between the nodes 500 and fibrils 502. Therefore, in some examples, the top surface 203 and the bottom surface 205 may have pores with a maximum or average pore size ranging from 1µm to 5µm, 5µm to 10µm, 10µm to 20µm, 20µm to 30µm, 30µm to 40µm, 40µm to 50µm, 50µm to 60µm, 60µm to 70µm, 70µm to 80µm, 80µm to 90µm, 90µm to 100µm, or any other suitable value / range or combination of such ranges, as part of a pore structure that allows inward growth. In some examples, the outer regions 202 and 204 may be formed entirely of a pore structure that inhibits tissue growth (such as one or more nodes 500), such that the inner region 200 may have a similar pore structure to the outer regions 202 and 204. In some examples, the inner region 200 and the outer regions 202 and 204 may be integral or formed as a single continuous material, such that regions 200, 202, and 204 can be considered as a single continuous region having the material shown in region 200, which extends the distance between surfaces 203 and 205. In another embodiment, region 200 may have sufficient thickness to extend as a single region over the distance between surfaces 203 and 205, such that region 200 defines surfaces 203 and 205.

[0135] Various modifications and additions may be made to the exemplary embodiments discussed without departing from the scope of this disclosure. For example, while the embodiments described above refer to specific features, the scope of this disclosure also includes embodiments having different combinations of features as well as embodiments that do not include all of the stated features. Therefore, the scope of this disclosure is intended to cover all such alternatives, modifications, and variations falling within the scope of the claims, and all their equivalents.

Claims

1. A scleral space implant for implantation into a scleral space created during a deep sclerectomy procedure performed on a human eye, the deep sclerectomy procedure involving the removal of ocular tissue to define the scleral space between a superficial scleral flap and the inner wall of the Schlemm's canal of the eye, the inner wall of the Schlemm's canal limiting the inflow of aqueous humor into the scleral space, the scleral space implant comprising: A single porous substrate has a top surface and an opposing bottom surface, the top surface and the opposing bottom surface defining an implant interior and a uniform implant thickness disposed between the opposing top and bottom surfaces. The substrate also has implant rigidity, which maintains the implant thickness when the implant is disposed in the scleral space. The top and bottom surfaces of the substrate each have a tissue-inhibiting pore structure that inhibits inward-growing tissue from entering the implant while allowing aqueous humor to flow into the implant. The implant has a connecting hole structure that facilitates the inflow of aqueous humor through the implant.

2. The implant according to claim 1, characterized in that, The single porous substrate further includes at least one external region having an inward-growing pore structure that allows inward-growing tissue to enter the at least one external region.

3. The implant according to claim 2, characterized in that, The single porous substrate has an open-closed-open-closed-open configuration.

4. The implant according to at least one of claims 1-3, characterized in that, The top surface and the bottom surface each define an outer peripheral edge, which cooperates to completely enclose the interior of the implant in at least one cross-sectional plane passing through the implant.

5. The implant according to at least one of claims 1-4, characterized in that, The single porous substrate is trimmable to define an implant profile that conforms to the scleral space.

6. The implant according to claim 5, characterized in that, The implant is positioned completely beneath the superficial scleral flap after being trimmed and inserted.

7. The implant according to at least one of claims 1-6, characterized in that, The top surface defines a scleral flap plane for receiving the superficial scleral flap and maintaining the superficial scleral flap in a planar orientation.

8. The implant according to at least one of claims 1-7, characterized in that, The channel extends from the bottom surface adjacent to the inner wall of the Schlem tube, passes through the interior of the implant, and reaches the outflow surface of the implant that facilitates the removal of aqueous humor from the scleral space.

9. The implant according to at least one of claims 1-8, characterized in that, The single porous substrate includes a tail portion extending from the scleral space.

10. The implant according to claim 9, characterized in that, The outflow surface is located at the tail portion.

11. The implant according to claim 10, characterized in that, The tail portion is trimmable to be flush with the outer surface of the superficial scleral flap.

12. The implant according to at least one of claims 1-11, characterized in that, The single porous substrate includes polyethylene (PE), expanded polyethylene (ePE), expanded polytetrafluoroethylene (ePTFE), or silicone.

13. The implant according to at least one of claims 1-12, characterized in that, The deep scleral excision procedure does not involve the use of antimetabolites.

14. The implant according to at least one of claims 1-13, characterized in that, The bottom surface includes a Schlem tube junction configured to receive the aqueous humor entering the scleral space.

15. The implant according to at least one of claims 1-14, characterized in that, The pore structure of the inhibited tissue includes pores with a minimum pore size ranging from 0.01µm to 1µm.

16. The implant according to at least one of claims 1-15, characterized in that, The pore structure of the inhibited tissue includes pores with an average pore diameter ranging from 0.01µm to 1µm.

17. The implant according to at least one of claims 1-16, characterized in that, The connection hole structure includes PE, ePE, ePTFE, or silicone.

18. The implant according to at least one of claims 1-17, characterized in that, The connection hole structure includes a first region and a second region having holes, wherein the holes in the first region have a minimum hole diameter from 0.01µm to 1µm, and the holes in the second region have a maximum hole diameter from 1µm to 100µm.

19. The implant according to at least one of claims 1-18, characterized in that, The connection hole structure includes a first region and a second region having holes, wherein the holes in the first region have an average hole diameter from 0.01µm to 1µm, and the holes in the second region have an average hole diameter from 1µm to 100µm.

20. The implant according to at least one of claims 1-19, characterized in that, The permissible inward-growing pore structure includes PE, ePE, ePTFE, or silicone.

21. The implant according to at least one of claims 1-20, characterized in that, The permissible inward-growing pore structures include pores with a maximum pore diameter ranging from 1µm to 100µm.

22. The implant according to at least one of claims 1-21, characterized in that, The inward-growing pore structures include pores with an average pore diameter ranging from 1 µm to 100 µm.

23. A scleral space implant for implantation into a scleral space created during a deep sclerectomy procedure performed on a human eye, the deep sclerectomy procedure involving the removal of ocular tissue to define the scleral space between a superficial scleral flap and the inner wall of the Schlemm's canal of the eye, the inner wall of the Schlemm's canal defining the inflow of aqueous humor into the scleral space, the scleral space implant comprising: A single porous substrate has a top surface and an opposing bottom surface, the top surface and the opposing bottom surface defining an implant interior and a uniform implant thickness disposed between the opposing top and bottom surfaces. The substrate also has implant rigidity, which maintains the implant thickness when the implant is disposed in the scleral space. The single porous substrate includes a tissue-inhibiting pore structure extending through a large portion of the implant thickness, the tissue-inhibiting pore structure inhibiting inward-growing tissue from entering the implant while allowing aqueous humor inflow into the implant.

24. The implant according to claim 23, characterized in that, The pore structure of the inhibited tissue includes polyethylene (PE), expanded polyethylene (ePE), expanded polytetrafluoroethylene (ePTFE), or organosilicon.

25. The implant according to at least one of claims 23-24, characterized in that, The top and bottom surfaces have holes with a maximum aperture ranging from 1µm to 100µm.

26. The implant according to at least one of claims 23-24, characterized in that, The top and bottom surfaces have holes with an average aperture ranging from 1µm to 100µm.

27. The implant according to at least one of claims 23-26, characterized in that, The bottom surface includes a Schlem tube junction configured to receive the aqueous humor entering the scleral space.

28. The implant according to at least one of claims 23-27, characterized in that, The single porous substrate is trimmable to define an implant profile that conforms to the scleral space.

29. The implant according to at least one of claims 23-28, characterized in that, The top surface defines a scleral flap plane for receiving the superficial scleral flap and maintaining the superficial scleral flap in a planar orientation.

30. The implant according to at least one of claims 23-29, characterized in that, The single porous substrate includes a tail portion extending from the scleral space.

31. The implant according to at least one of claims 23-30, characterized in that, The deep scleral excision procedure does not involve the use of antimetabolites.

32. The implant according to at least one of claims 23-31, characterized in that, The deep scleral excision procedure maintains the natural healing ability of the tissues that define the scleral space.

33. A scleral space implant for implantation into the sclera of the eye to treat glaucoma in conjunction with a deep scleral resection procedure that defines a scleral space situated within surrounding tissue, said implant comprising: A first outer region, the first outer region having a first porosity that inhibits tissue inward growth and promotes aqueous humor flow therethrough; The second outer region has a second porosity that inhibits inward tissue growth and promotes aqueous humor flow through it. as well as An internal region is disposed between the first external region and the second external region, the internal region having a third porosity greater than the first porosity and the second porosity to facilitate fluid flow through it. The first outer region, the second outer region, and the inner region have stiffness to resist contractile forces exerted from the surrounding tissue.

34. The implant according to claim 33, characterized in that, It also includes an additional region disposed on the first outer region, such that the first outer region is disposed between the additional region and the inner region, the additional region having a fourth porosity greater than the first porosity and the second porosity.

35. The implant according to any one of claims 33-34, characterized in that, A tail portion is defined by the first outer region, the second outer region, and a portion of the inner region, the tail portion extending from the remainder of the body portion defined by the first outer region, the second outer region, and the inner region, wherein the tail portion protrudes from a portion of the sclera in which the implant is inserted, such that only the body portion of the implant remains inside the sclera.

36. The implant according to any one of claims 33-35, characterized in that, The first outer region, the second outer region, and the inner region include multiple nodes and multiple fibrils, the fibrils extending between the nodes to define pores between the fibrils.

37. The implant according to any one of claims 33-36, characterized in that, The first outer region includes a first spacer, and the second outer region includes a second spacer, wherein the first spacer and the second spacer inhibit the tissue from growing inward into the inner region.

38. The implant according to claim 37, characterized in that, The internal region includes a plurality of support sections extending from the first partition to the second partition.

39. The implant according to any one of claims 33-38, characterized in that, The implant does not expand and is dimensionally stable when wetted.

40. The implant according to any one of claims 33-39, characterized in that, The implant is made of one or more biocompatible and non-biodegradable materials.

41. The implant according to at least one of claims 33-40, characterized in that, The deep scleral excision procedure does not involve the use of antimetabolites.

42. A method for treating glaucoma by draining excess aqueous humor from the human eye in conjunction with a deep scleral resection procedure that defines the scleral space, the method comprising: The inflow from the exposed inner wall of the Schlem tube is directed into the interior of the scleral space implant disposed in the scleral space; Inhibits inward tissue growth from the scleral space into the implant; as well as The inflow is guided through the implant to an outlet that communicates with the outside of the eye.

43. The method according to claim 42, characterized in that, The implant includes a guiding connection hole structure that facilitates the inflow.

44. The method according to any one of claims 42-43, characterized in that, The scleral space implant includes an outer surface with a pore structure that inhibits tissue growth into the implant.

45. The method according to any one of claims 42-44, characterized in that, Also includes: Trim the outer peripheral edge of the scleral space implant to conform to the scleral space.

46. ​​The method according to any one of claims 42-45, characterized in that, Also includes: The superficial scleral flap is supported by a planar orientation.

47. The method according to any one of claims 42-46, characterized in that, The pore structure of the inhibited tissue includes polyethylene (PE), expanded polyethylene (ePE), expanded polytetrafluoroethylene (ePTFE), or organosilicon.

48. The method according to any one of claims 42-47, characterized in that, The connection hole structure includes PE, ePE, ePTFE, or silicone.

49. The method according to at least one of claims 42-48, characterized in that, The deep scleral excision procedure does not involve the use of antimetabolites.

Images