Implantable shunts with features for disrupting fibrosis and / or other biological responses, and associated systems and methods

Abstract

The present technology is generally directed to shunting systems having features designed to inhibit or disrupt an inflammatory or fibrotic response in the body, and associated systems and methods. For example, the disclosed shunting systems may have surface features including a plurality of protrusions and recesses configured to impede the development of fibrosis and thereby maintain patency of a bleb in / on an eye in which a shunting system is implanted. Multiple layers with surface features can be applied to and combined on an exterior surface of a shunting system to form a textured surface. The structure, arrangement, and dimensions of the surface features can be randomized to reduce the likelihood of organized fibroblast cell growth.

Description

IMPLANTABLE SHUNTS WITH FEATURES FOR DISRUPTING FIBROSIS AND / OR OTHER BIOLOGICAL RESPONSES, AND ASSOCIATED SYSTEMS AND METHODSCROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] The present application claims the benefit of U.S. Provisional Patent Application No. 63 / 580,891, filed September 6, 2023, the disclosure of which is incorporated herein by reference in its entirety.TECHNICAL FIELD

[0002] The present technology generally relates to implantable medical devices and. in particular, to implantable shunting systems with features for disrupting fibrosis and / or other biological responses.BACKGROUND

[0003] Implantable shunts have been used to treat glaucoma by creating an artificial drainage pathway from the anterior chamber to relieve excess pressure in the anterior chamber. As part of the surgical procedure to implant the shunt, a surgeon may create a “bleb,” which can be a chamber or other opening in the patient’s eye, such as a small, blister-like elevation that forms on the surface of the eye or at another suitable location. The bleb can serve as a target outflow location for shunting fluid from the anterior chamber via the shunt. However, the normal healing process of the eye can result in the development of fibrosis within or proximate the bleb, which can lead to bleb encapsulation, scarring, and potential failure of the implantable shunt (e.g., by increasing the resistance through the shunt, by blocking shunt outflow, etc.). Conventional methods to interfere with fibrosis development include introducing antifibrotic agents such as mitomycin during surgery and using shunts with improved biocompatibility, such as by employing different materials. However, such methods can fail to adequately reduce fibrosis development, and / or using antifibrotic agents may induce undesirable side effects in the patient. Therefore, there is a need for safe and effective methods for interfering with fibrosis development to maintain bleb patency following a surgery to implant a glaucoma shunt.BRIEF DESCRIPTION OF THE DRAWINGS

[0004] Many aspects of the present technology can be better understood with reference to the following drawings. The components in the drawings are not necessarily drawn to scale. Instead, emphasis is placed on illustrating clearly the principles of the present technology. Furthermore, components can be shown as transparent in certain views for clarity of illustration only and not to indicate that the component is necessarily transparent. Components may also be shown schematically.

[0005] FIGS. 1A and IB are top and exploded perspective views, respectively, of a shunting system with a textured surface and configured in accordance with an embodiment of the present technology.

[0006] FIGS. 2A and 2B are perspective and enlarged views, respectively, of a textured surface for use with a shunting system and configured in accordance with an embodiment of the present technology.

[0007] FIGS. 3 A and 3B are top views of another textured surface for use with a shunting system and configured in accordance with other embodiments of the present technology.

[0008] FIG. 4 is a schematic view illustrating the combination of two textured layers to form a composite textured surface for use with a shunting system and configured in accordance with an embodiment of the present technology.

[0009] FIG. 5 is a side view of a textured surface for use with a shunting system and configured in accordance with an embodiment of the present technology.

[0010] FIGS. 6A-6D are top views of textured surfaces with varying feature densities for use with a shunting system and configured in accordance with other embodiments of the present technology.

[0011] FIG. 7 is a schematic view illustrating the combination of two textured layers to form a composite textured surface for use with a shunting system and configured in accordance with an embodiment of the present technology'.

[0012] FIG. 8 is a schematic view illustrating the combination of three textured layers to form a composite textured surface for use with a shunting system and configured in accordance with an embodiment of the present technology’.

[0013] FIG. 9 is a side view of a textured surface for use with a shunting system and configured in accordance with an embodiment of the present technology.

[0014] FIG. 10 is a schematic view illustrating the combination of three textured layers to form a composite textured surface for use with a shunting system and configured in accordance with an embodiment of the present technology.

[0015] FIG. 11 is a side view of a textured surface for use with a shunting system and configured in accordance with an embodiment of the present technology.

[0016] FIGS. 12A-12C are enlarged top, see-through side, and see-through perspective views, respectively, of select portions of shunting system combined with upward diffusion outflow and configured in accordance with an embodiment of the present technology.

[0017] FIG. 13A is a top view of a shunting system with a microfluidic diffuse outflow array combined with current channels and configured in accordance with an embodiment of the present technology.

[0018] FIG. 13B is an enlarged view of the microfluidic diffuse outflow array of the shunting system of FIG. 13 A.

[0019] FIGS. 14A-14C are bottom, bottom perspective, and enlarged views, respectively, of a shunting system providing increased outflow redundancy and configured in accordance with an embodiment of the present technology.

[0020] FIGS. 15A-15C are exploded, top, and cross-sectional views, respectively, of a shunting system with a reservoir and configured in accordance with an embodiment of the present technology.

[0021] FIGS. 16A-16E are perspective, top, side cross-sectional, top cross-sectional, and bottom cross-sectional views, respectively, of a shunting system with an elongated second end portion and configured in accordance with an embodiment of the present technology.

[0022] FIGS. 17A-17E are perspective, top, side cross-sectional, top cross-sectional, and bottom cross-sectional views, respectively, of a shunting system with an enlarged second end portion and configured in accordance with an embodiment of the present technology.

[0023] FIG. 18 is an enlarged top view of a portion of a shunting system with a microtexturing pattern and configured in accordance with an embodiment of the present technology.

[0024] FIG. 19 is a top view of a portion of a shunting system with the microtexturing pattern of FIG. 18 in a first arrangement and configured in accordance with an embodiment of the present technology.

[0025] FIG. 20 is a top view of a portion of another shunting system with the microtexturing pattern of FIG. 18 in a second arrangement and configured in accordance with an embodiment of the present technology.DETAILED DESCRIPTION

[0026] The present technology is generally directed to implantable shunts having features designed to inhibit or reduce an inflammatory or fibrotic response in the body, and associated systems and methods. Shunting systems are commonly used to promote the flow of fluid between a first body region, such as the anterior chamber of an eye, and a second body region, such as a bleb surgically created in / on the eye. As described throughout this Detailed Description, shunting systems configured in accordance with the present technology can have various antiproliferative features that are expected to inhibit or reduce the likelihood of bleb and / or shunt failure due to scarring and / or tissue overgrowth. For example, in many embodiments described herein, the shunting systems include one or more anti-proliferative “surface features,"’ such as one or more textured, irregular, or otherwise “unsmooth"’ surfaces. The textured surface can include a plurality of protrusions and / or recesses arranged in a predetermined, uniform, and / or random pattern. In some embodiments, the textured surface can be formed by applying and combining multiple layers, each with their own set of protrusions, recesses, or other features. Other anti-proliferative features include diffuse outflow arrays and enlarged outflow regions, which can be utilized alone or in combination with other features. As described in detail throughout this Detailed Description, and without being bound by theory, such anti-proliferative features are expected to interfere with fibrotic and other processes in the eye, e.g., to reduce the likelihood of bleb failure and / or shunt encapsulation.

[0027] In some embodiments, the surface features can be formed by combining a first layer with a first set of protrusions and a second layer with a second set of protrusions. The first and second sets of protrusions can have different protrusion heights such that the combined textured surface has protrusions that vary in height. In some embodiments, another layer (e.g., a third layer) with a set of recesses or holes can be combined with the first layer and the second layer. In some embodiments, each layer can have the same or different surface feature densities. In some embodiments, the cross-sectional shape, the dimensions, and the arrangement of thesurface features (e.g., protrusions, recesses, holes, etc.) can be randomized or otherwise designed to be irregular to reduce the likelihood of organized fibroblast cell growth.

[0028] The terminology used in the description presented below is intended to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of certain specific embodiments of the present technology. Certain terms may even be emphasized below; however, any terminology7intended to be interpreted in any restricted manner will be overtly and specifically defined as such in this Detailed Description section. Additionally, the present technology can include other embodiments that are within the scope of the claims, but are not described in detail with respect to FIGS. 1A-20.

[0029] Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present technology7. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features or characteristics may be combined in any suitable manner in one or more embodiments.

[0030] As used herein, the use of relative terminology7, such as “about,” “approximately,” “substantially” and the like refer to the stated value plus or minus ten percent. For example, the use of the term “about 100” refers to a range of from 90 to 110, inclusive. In instances in which the context requires otherwise and / or relative terminology is used in reference to something that does not include a numerical value, the terms are given their ordinary7meaning to one skilled in the art.

[0031] The headings below are provided by way of convenience only and are not to be used to interpret the scope of the claimed technology7.A. Select Embodiments of Implantable Shunting Systems

[0032] FIGS. 1A and IB are top and exploded perspective views, respectively, of a shunting system 100 (“the system 100”) with a textured or irregular surface 150 and configured in accordance with an embodiment of the present technology. As described in greater detail below, the system 100 is configured to shunt fluid from a first body region to a second body region, such as shunting aqueous from an anterior chamber of a patient's eye to a target outflow location (e.g., a bleb).

[0033] Referring first to FIG. 1A, the system 100 includes a shunting element 102. The shunting element 102 (which can also be referred to as an elongated housing or the like) extends between a first end portion 102a and a second end portion 102b. A plurality of flow channels 104 (not visible in FIG. 1 A — see FIG. IB) can extend through the shunting element 102 at least partially between the first end portion 102a and the second end portion 102b. As described in greater detail below, when the system 100 is implanted within a patient between a first body region and a second body region, fluid can flow from the first body region to the second body region via the flow channels 104. The shunting element 102 may optionally include one or more features to facilitate anchoring the system 100 to patient tissue, such as first and second suture holes 108a, 108b. The shunting element 102 can be composed of a partially flexible and / or biocompatible material, such as silicone. polydimethylsiloxane (PDMS), polymethylmethacrylate (PMA), or the like. For example, the shunting element 102 may be composed of a material having a durometer of between about 60 and about 90, or between about 70 and 80, or about 75. In some embodiments, the shunting element 102 can be fabricated using manufacturing processes and techniques similar to semiconductor fabrication techniques. Without intending to be bound by theory, use of such techniques is expected to enable certain features of the system 100, such as the features described below in Sections B and C that are expected to disrupt fibrosis, to be created with greater control and / or with a wider variety of potential designs.

[0034] Referring next to FIG. IB, the shunting element 102 can include one or more components and / or layers that are stacked and coupled (e.g., sealed) together to collectively form the shunting element 102. For example, the shunting element 102 can include a first (e.g.. top) layer 1 10, a second (e.g., middle) layer 112, and a third (e.g., bottom) layer 114. Accordingly, in the illustrated embodiment the shunting element 102 includes three layers, although in other embodiments the shunting element 102 can include more or fewer layers, such as one, two, four, five, six, or more layers. In operation, the first layer 110. the second layer 112. and the third layer 1 14 are sealed together (e.g., glued, adhered, bonded, etc.) to form the shunting element 102. More specifically, a lower surface of the first layer 110 is sealed to an upper surface of the second layer 112, and a lower surface of the second layer 112 is sealed to an upper surface of the third layer 114. Sealing the layers prevents or at least reduces fluid from leaking through the system 100 between layers. Additional details regarding multi-layered shunting systems are described in International Patent Application No. PCT / US2022 / 037917, the disclosure of which is incorporated by reference herein in its entirety. In other embodiments, the shunting element 102is formed from a single, contiguous structure, without the need for sealing a plurality of layers together.

[0035] The shunting element 102 can include an anti-proliferative feature in the form of the textured surface 150 (which can also be referred to as an “irregular,” “bumpy,” “rough,” or “unsmooth” surface) proximate the second end portion 102b and on a top (e.g., outward facing) surface of the first layer 110, as shown in FIGS. 1 A and IB. In some embodiments, the textured surface 150 can be included elsewhere on the first layer 110, and / or elsewhere on the system 100. For example, the textured surface 150 can cover an entirety of the top surface of the first layer 110. As another example, the textured surface 150 can also cover a bottom (e.g., outward facing) surface of the third layer 114. As described in greater detail below, when the system 100 is implanted within a patient, the textured surface 150 can interfere with fibrosis development and reduce eventual scarring.

[0036] Returning to FIG. IB, the first layer 110 includes an opening 111 that permits fluid to flow into the shunting element 102 (or, depending on the orientation of, and direction of flow through, the shunting element 102, fluid can flow out of the opening 11 1). In addition to permitting fluid to flow into the shunting element 102, the opening 111 enables a user to have an unobstructed view' of at least a portion of the actuation assembly 120. For example, when the system 100 is assembled as shown in FIG. 1A, a portion of the actuation assembly 120 can be aligned with the opening 111. Although shown as having a single opening, in some embodiments the first layer 110 may have two more openings.

[0037] The second layer 112 includes a chamber or cavity 116 at the first end portion 102a, with an opening to the chamber 116 facing toward the first layer 110. The chamber 116 provides an empty space or cavity for receiving an actuation assembly 120, described below'. The chamber 116 also includes several openings (e.g., ports, apertures, etc.). For example, the chamber 116 includes a first aperture 117a. a second aperture 117b. and a third aperture 117c (collectively referred to as “the apertures 117”). The apertures 117 extend fully through the second layer 112 such that fluid can flow through the second layer 112 via the apertures 117.

[0038] The third layer 114 defines or at least partially defines the flow channels 104 that extend through the shunting element 102. In the illustrated embodiment, for example, the third layer 114 defines a first channel 104a, a second channel 104b. and a third channel 104c (collectively referred to as “the channels 104”). More specifically, a void space of the channels 104 can be formed within the third layer 114, with the second layer 112 forming a “top” of thechannels 104 (e.g., the channels 104 become closed off once the second layer 112 is sealed to the third layer 114). The third layer 114 also defines a first well 115a fluidly coupled to the first channel 104a at the first end portion 102a, a second well 115b fluidly coupled to the second channel 104b at the first end portion 102a, and a third well 115c fluidly coupled to the third channel 104c at the first end portion 102a. The first well 115a is aligned with, and therefore configured to receive fluid from, the first aperture 117a of the second layer 112. Likewise, the second well 115b is aligned with, and therefore configured to receive fluid from, the second aperture 117b of the second layer 112, and the third well 115c is aligned with, and therefore configured to receive fluid from, the third aperture 117c.

[0039] The channels 104 can be designed to provide different fluid resistances. For example, each of the channels 104 may have a different cross-sectional dimension (e.g., cross- sectional area, diameter, circumference, perimeter, etc.) and / or length. For example, the first channel 104a may have a first cross-sectional area, the second channel 104b may have a second cross-sectional area greater than the first cross-sectional area, and the third channel 104c may have a third cross-sectional area that is greater than the first cross-sectional area but less than the second cross-sectional area. If the length of the channels 104 are the same in such embodiments, the first channel 104a has the highest fluid resistance, the second channel 104b has the lowest fluid resistance, and the third channel 104c has an intermediate fluid resistance. The foregoing is provided by way of example only — a person skilled in the art will appreciate that the channels 104 can be designed with any combination of cross-sectional dimensions and lengths to achieve desired relative resistances.

[0040] In some embodiments, the system 100 can optionally include an actuation or control assembly 120 to selectively control and / or adjust a fluid resistance through the system 100. Referring collectively to FIGS. 1A and IB, the actuation assembly 120 can be positioned at or proximate the first end portion 102a of the shunting element 102 (e.g., within the chamber 116), and can include one or more actuators 124 that selectively control the flow of fluid through one or more of the flow channels extending through the shunting element 102 (e.g., by gating the apertures 117). In this way, the actuation assembly 120 can enable a user (e.g., physician) to selectively titrate the therapy provided by the system in response to changes in a patient’s condition. Additional details regarding actuation assemblies similar to the actuation assembly 120 are described in U.S. Patent Application Publication No. 2021 / 0251806 and U.S. Provisional Patent Application No. 63 / 497, 127, the disclosure of which are incorporated by reference herein in their entireties.

[0041] When the system 100 is implanted in a patient, the shunting element 102 can be oriented such that the first end portion 102a is at or proximate to the anterior chamber of an eye and the second end portion 102b with the textured surface 150 is at or proximate to a bleb. During the normal healing process of the bleb, fibroblast cells can begin to form, grow, and multiply within the bleb and / or on the second end portion 102b of the shunting element 102, eventually leading to the development of fibrosis. The fibrosis can further develop into scars, which can be undesirable in the bleb context if it reduces the volume of the bleb and / or blocks fluid from flowing out of the system 100. As described in further detail below in Section B, the textured surface 150 is expected to interfere with fibrosis development in the bleb and thereby may help maintain the patency of the bleb, and thus can be referred to herein as an anti-proliferative feature.

[0042] A person skilled in the art will appreciate that the system 100 is just one example of a shunting system on which the textured surface 150 can be applied. Indeed, the textured surface 150 can be applied on other shunting systems, such as those described in U.S. Patent Application Publication Nos. US2020 / 0229982 and US2021 / 0251806, and International Patent Application Nos. PCT / US2021 / 049140, PCT / US2022 / 037747, and PCT / US2022 / 037917, each of which is incorporated by reference herein in its entirety’, as well as other shunting systems.B. Select Embodiments of Anti-Proliferative Surface Features. Including Textured and / or Irregular Surfaces, for use with Shunting Systems

[0043] As set forth above, the present technology’ includes shunting systems having antiproliferative surface features that are designed to interfere with fibroblasts and therefore reduce the development of fibrosis. For example, FIGS. 2A-11 and 18-20, described below, each illustrate various examples of surface features configured in accordance with the present technology and that are expected to interfere with fibroblasts and therefore reduce the development of fibrosis over the shunt and / or in the bleb. As one skilled in the art will appreciate, any of the examples shown in FIGS. 2A-11 and 18-20 can be incorporated into the systems 100 of FIGS. 1A and IB, or into other shunts.

[0044] FIGS. 2A and 2B are perspective and enlarged views, respectively of a textured or irregular surface 250 configured in accordance with an embodiment of the present technology’. The textured surface 250 can be an example of the textured surface 150 illustrated in and described above with respect to FIGS. 1A and IB, and / or can be used with another shuntingsystem. As beter shown in FIG. 2B, the textured surface 250 includes a plurality of surface features, including a plurality’ of bumps or protrusions 260 ("‘protrusions 260”) and / or a plurality of holes or recesses 270 (‘‘recesses 270”). In some embodiments, the textured surface 250 is integrally formed with an underlying shunting element (e.g., the shunting element 102). For example, the textured surface 250 can be part of the first layer 110 of the shunting element 102 of FIGS. 1A and IB. In some embodiments, the textured surface 250 can be added as a separate layer disposed on top of an underlying shunting element. Regardless, the textured surface 250 can be composed of a partially flexible and / or biocompatible material, such as silicone, polydimethylsiloxane (PDMS), polymethylmethacrylate (PMA), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), or the like. In embodiments in which the textured surface 250 is integral with a layer of the shunting element, the textured surface 250 is composed of the same material as the shunting element and may provide manufacturing efficiencies.

[0045] With continued reference to FIG. 2B, individual ones of the protrusions 260 and the recesses 270 are shown as having circular cross-sections. In other embodiments, however, individual ones of the protrusions 260 and the recesses 270 can have other cross-sections or shapes, examples of which are illustrated below in FIGS. 3A and 3B. As shown, at least some of the protrusions 260 and the recesses 270 can have different dimensions (e.g., a height of the protrusion 260, a depth of the recess 270, a diameter of the protrusion 260 or recess 270, etc. can vary' betw een individual protrusions 260 and recesses 270). In some embodiments, some or all of the protrusions 260 and the recesses 270 have the same or similar dimensions. The arrangement of the protrusions 260 and the recesses 270 can be according to a predetermined, repeating patern (e.g., arranged in a grid or “tiled”), or can be randomized or otherwise irregular.

[0046] Without intending to be bound by theory, the surface features (e.g., the protrusions 260 and the recesses 270) of the textured surface 250 can interfere with the adherence and patterning of fibroblasts or other inflammatory / immune cells on the surface of the shunting system that are atracted to the shunting system after it is implanted in the patient. As a result, the textured surface 250 may interfere with the development of fibrosis over at least the portions of the shunting system that include the textured surface 250. Thus, placing the textured surface 250 on a portion of the shunting system that is positioned within the bleb when implanted is expected to interfere with the development of fibrosis in the bleb. In some cases, the randomization of the dimensions and arrangement of the protrusions 260 and / or the recesses 270may further interfere with the organization of fibroblast cells in the bleb, thereby further decreasing capsular thickness of the fibrosis.

[0047] FIGS. 3A and 3B are top views of a textured or irregular surface 350 configured in accordance with other embodiments of the present technology. The textured surface 350 can be an example of the textured surface 150 illustrated in and described above with respect to FIGS. 1 A and IB, and / or can be used with another shunting system. As shown in FIG. 3A, the textured surface 350 can include first surface features 360a having a shape of two overlapping circles (e.g., a lemniscate shape). As shown in FIG. 3B, the textured surface 350 can alternatively include second surface features 260b having a diamond shape. In some embodiments, the surface features 360a, 360b are protrusions that extend from the surface 350. In other embodiments, the surface features 360a, 360b are recesses and / or holes in the surface 350. In yet other embodiments, the surface features 360a. 260b are a mixture of protrusions and recesses.

[0048] As one skilled in the art will appreciate, the textured surface 350 can include surface features, including protrusions and / or recesses, of other shapes beyond those shown in FIGS. 3A and 3B. Example shapes include, but are not limited to, triangular, rectangular, pentagonal, hexagonal, elliptical, semi-circular, etc. In some embodiments, the textured surface 350 can include a combination of surface features 360 with different cross-sectional shapes.

[0049] FIG. 4 is a schematic view illustrating the combination of two layers to form a textured or irregular surface for use with a shunting systema and configured in accordance with an embodiment of the present technology. Specifically, the left side of FIG. 4 illustrates a first layer 450a with first surface features 460a (e.g., first protrusions and / or recesses) and a second layer 450b with second surface features 460b (e.g., second protrusions and / or recesses). The first layer 450a and the second layer 450b can be overlayed (e.g., stacked) to form a textured surface 450c (e.g., a composite textured surface). The right side of FIG. 4 illustrates the textured surface 450c formed by combining or overlaying the first and second layers 450a, 450b. The textured surface 450c can include third surface features 460c, which can be defined by the combination of the first surface features 460a and the second surface features 460b.

[0050] In the illustrated embodiment, the second surface features 460b on the second layer 450b are more densely arranged than the first surface features 460a on the first layer 450a. Accordingly, the first and second layers 450a. 450b can be combined such that some individual ones of the first surface features 460a overlap with individual ones of the second surface features 460b w hile at least some of the second surface features 460b do not overlap with the first surfacefeatures 460a. Therefore, the third surface features 460c of the textured surface 450c can include a first set of third surface features 460c- 1 corresponding to the non-overlapping ones of the second surface features 460b, and a second set of third surface features 460c-2 corresponding to overlapping ones of the first and second surface features 460a, 460b. In some embodiments, the first and second surface features 460a, 460b include protrusions such that the second set of third surface features 460c-2 includes protrusions, each with a height corresponding or similar to a combined height of the overlapping protrusions of the first and second surface features 460a, 460b. Therefore, the textured surface 450c can include surface features with varying dimensions (e.g., protrusion heights).

[0051] Without intending to be bound by theory, incorporating projections of varying dimensions (e.g., heights) may further interfere with fibroblasts adhesion to the textured surface 450c (thereby reducing fibrosis), as compared to projections having a uniform height. Further, creating the variable height projections by combining two different layers each having uniform projections may simplify the manufacturing process, as depending on the manufacturing process it may be simpler and / or cheaper to manufacture multiple layers each having uniform properties instead of a single layer having variable properties.

[0052] FIG. 5 is a side view of another textured or irregular surface 550 configured in accordance with an embodiment of the present technology. The textured surface 550 can include a base 552 with a first thickness DI and a plurality of protrusions 560 extending from the base 552 (four protrusions are illustrated in FIG. 5). The first thickness DI can be between about 10 pm and about 50 pm, or between about 20 pm and about 40 pm, or about 30 pm. In some embodiments, individual ones of the protrusions 560 can have a height H that ranges between 10 pm and 50 pm, such as between about 20 pm and about 40 pm. In the illustrated embodiment, for example, a first one of the protrusions 560a has a height of about 20 pm and a second one of the protrusions 560b has a height of about 40 pm. Accordingly, the textured surface 550 can have a total thickness D2 or D3 (e.g., including the base 552 and one of the protrusions 560) that ranges between about 20 pm and 100 pm. In the illustrated embodiment, for example, the total thickness D2 for the first one of the protrusions 560a is about 50 pm and the total thickness D3 for a second one of the protrusions 560b is about 70 pm. In some embodiments, individual ones of the protrusions 560 can have a cross-sectional dimension D4 (e.g., width, diameter) that ranges between about 0.1 mm and about 0.3 mm (e.g., about 0.2 mm). In some embodiments, adjacent ones of the protrusions 560 can be spaced apart by a distance D5 that ranges between about 0.1 mm and about 0.5 mm (e.g., about 0.3 mm). The foregoing dimensions are providedby way of example only — a person skilled in the art will appreciate that the dimensions (e.g., height and width) and the arrangement (e.g.. spacing) of the protrusions 560 can have other dimensions as needed and / or randomized.

[0053] FIGS. 6A-6D are top views of additional textured or irregular surfaces 650 with varying surface feature densities and that are configured in accordance with embodiments of the present technology. Specifically, FIG. 6 A illustrates a first textured surface 650a with a plurality of surface features 660 (e.g.. protrusions and / or recesses) arranged to have a first density, FIG. 6B illustrates a second textured surface 650b with a plurality of surface features 660 arranged to have a second density, FIG. 6C illustrates a third textured surface 650c with a plurality’ of surface features 660 arranged to have a third density, and FIG. 6D illustrates a fourth textured surface 650a with a plurality of surface features 660 arranged to have a fourth density. As shown, the fourth density can be greater than the third density, which can be greater than the second density, which can be greater than the first density. In some embodiments, the first density can be between 5-15 per mm2, such as about 10 per mm2(i.e., 10 surface features 660 per square millimeter), the second density can be between 15-25 per mm2, such as about 20 per mm2, the third density can be betw een 25-35 per mm2, such as about 30 per mm2, and the fourth density can be between 35-45 per mm2, such as about 40 per mm2. As one skilled in the art will appreciate, the foregoing density ranges and values are provided by w ay of example only — in other embodiments, the textured surfaces 650 may have densities outside the ranges described above. Regardless of the density of the textured surfaces 650, the surface features 660 can be arranged according to a predetermined (e.g., repeating) pattern or a random pattern. Moreover, any of the textured surfaces described herein (e.g., including those described above with reference to FIGS. 2A-5) can be designed to have the densities shown in FIGS. 6A-6D. In some embodiments, each of the textured surfaces 650 can comprise a layer that can be combined, as illustrated in FIG. 4 and described below with reference to FIGS. 7 and 8, to form a composite textured surface with varying surface feature dimensions and / or an increased surface feature density.

[0054] FIG. 7 is a schematic view illustrating the combination of two individually textured or irregular layers having different surface feature densities to form a textured or irregular surface having a greater surface feature density’ and that is configured in accordance w ith an embodiment of the present technology7. Specifically, a first layer 750a with a first set of surface features 760a (e.g., protrusions) can be combined with a second layer 750b with a second set of surface features 760b to form a textured surface 750c with a third set of surface features 760c. In the illustrated embodiment, the first layer 750a has a low er surface feature density’ than the second layer 750b,although in other embodiments the first and second layers 750a, 750b can have the same or similar surface feature densities. Regardless, the textured surface 750c can have a greater surface feature density than the first or second layers 750a, 750b. In some embodiments, the maximum height of the third set of surface features 760c on the textured surface 750c ranges between about 10 gm and about 60 gm, or between about 30 gm and about 40 gm (e.g., about 34 gm).

[0055] FIG. 8 is a schematic view illustrating the combination of three individually textured or irregular layers each having different surface feature densities to form a textured or irregular surface that is configured in accordance with an embodiment of the present technology’. Specifically, a first layer 850a with a first set of surface features 860a (e.g., protrusions) and a first surface feature density can be combined with (a) a second layer 850b with a second set of surface features 860b and a second surface feature density, and (b) a third layer 850c with a third set of surface features 860c and a third surface feature density, to form a textured surface 850d with a fourth set of surface features 860d and a fourth surface feature density'. Although shown as each having different surface feature densities, in some embodiments on or more of the first, second, and third layers 850a, 850b, 850c can have the same or similar surface feature densities. In some embodiments, the maximum height of the fourth set of surface features 860d on the textured surface 850d ranges between about 20 gm and about 70 gm, or between about 40 gm and about 50 gm (e.g., about 45 gm).

[0056] FIG. 9 is a side view of another textured or irregular surface 950 configured in accordance with an embodiment of the present technology. In some embodiments, the textured surface 950 can be formed by stacking two, three, four, or more individual layers each having their own surface features and surface feature densities, as described with reference to FIGS. 7 and 8. In other embodiments, the textured surface 950 is a single layer. Regardless, the textured surface 950 can include a base 952 with a thickness D6 and a plurality7of protrusions 960 extending from the base 952. The thickness D6 can be between about 40 pm and about 80 gm, such as about 57 gm. A first one of the protrusions 960a has a first height D7 between about 10 gm and about 25 gm (e.g., about 17 gm) and a second one of the protrusions 960b has a second height D8 between about 20 gm and about 50 gm (e.g., about 34 gm). In some embodiments, adjacent ones of the protrusions 960 can be spaced apart by a distance D9 that ranges between about 0.1 mm and 0.3 mm. The foregoing dimensions are provided by way of example only — a person skilled in the art will appreciate that the dimensions (e.g., height and width) and the arrangement (e.g., spacing) of the protrusions 960 can have other dimensions as needed and / or randomized.

[0057] FIG. 10 is a schematic view illustrating another combination of three layers to form a textured or irregular surface configured in accordance with an embodiment of the present technology. Similar to the embodiment described with reference to FIG. 8, a first layer 1050a can have a first set of protrusions 1060a and be combined with a second layer 1050b with a second set of protrusions 1060b. Athird layer 1050c with a set of recesses 1070 can be combined with the first layer 1050a and the second layer 1050b to form a composite textured surface (not shown). Accordingly, relative to the layered textured surface of FIGS. 7 and 8. the textured surface formed in FIG. 10 has a set of surface features that includes both protrusions and recesses. In some embodiments, the first set of protrusions 1060a can include taller protrusions than the second set of protrusions 1060b such that the textured surface has two layers of protrusions and one layer of recesses. The first, second, and third layers 1050a. 1050b. 1050c can have the same, similar, or different surface feature densities, as described previously (e.g., about 15 to 50 per mm2). In some embodiments, the width or cross-sectional dimension of individual ones of the surface features on the textured surface can range between about 20 pm and 50 pm.

[0058] FIG. 11 is a side view of another textured or irregular surface 1150 configured in accordance with an embodiment of the present technology. Similar to embodiments described previously with reference to FIGS. 5 and 9, the textured surface 1150 can include a base layer 1152 and a plurality of protrusions 1160 on top of the base layer 1152. However, relative to the embodiments described previously with reference to FIG. 5 and 9, the textured surface 1150 can further include a plurality of recesses 1170 in the base layer 1152. Individual ones of the protrusions 1 160 can have a height D10 between about 15 pm and about 50 pm (e.g., about 25 pm, about 28 pm). Individual ones of the recesses 1170 can have a depth DI 1 between about 15 pm and about 50 pm (e.g., about 23 pm). In some embodiments, the total thickness of the textured surface 1150 can be between about 50 pm and about 100 pm (e.g., about 70 pm). A person skilled in the art will appreciate that the dimensions (e.g., height, depth, and / or width) and the arrangement (e.g., spacing) of the protrusions 1 160 and the recesses 1170 can be configured to other dimensions as needed and / or randomized.

[0059] FIG. 18 is an enlarged top view of a portion of a shunting system 1800 with a microtexturing pattern 1850 and configured in accordance with an embodiment of the present technology. The shunting system 1800 can include a shunting element 1810 (e.g., similar to the shunting element 102 of FIGS. 1A and IB), and the microtexturing pattern 1850 can be on a distal end portion of the shunting element 1810 (e.g., similar to the second end portion 102b ofFIGS. 1A and IB). In the illustrated embodiment, the microtexturing pattern 1850 includes a plurality of hexagonal wall structures 1852, one or more boundary wall structures 1854, and one or more outflow wall structures 1856 (e.g., the microtexturing pattern 1850 may not include any apertures).

[0060] The hexagonal wall structures 1852 can be evenly spaced apart and arranged in a repeating pattern or array on the shunting element 1810. As shown, the hexagonal w all structures 1852 can be formed by two parallel hexagonal walls extending upwardly from a surface of the shunting element 1810, such that the hexagonal wall structures 1852 are raised relative to the surface of the shunting element 1810. For example, individual hexagonal wall structures 1852 can be a boss on the surface of the shunting element 1810. The hexagonal w all structures 1852 can have a hollow (e.g., open) structure with a bottom surface that is coplanar with the outer surface of the shunting element 1810. In alternative embodiments, instead of being raised relative to the surface of the shunting element 1810, the hexagonal wall structures 1852 can instead be recessed relative to the surface of the shunting element 1810, and / or a combination of raised and recesses. Regardless, the lateral dimension D12 of the hexagonal wall structures 1852 can be between 1-100 pm or between 10-50 pm. such as 17 pm or 31 pm. Moreover, although shown as having a hexagonal shape, the hexagonal wall structures 1852 can have other shapes, such as circular, oval-shaped, triangular, square, rectangular, pentagonal, irregular, star-shaped, etc. the hexagonal wall structures 1852 can therefore generally be referred to as “wall structures,” “microtexturing wall structures”, or “mictrotexturing structures.”

[0061] The boundary wall structures 1854 can extend along and spaced apart from a lateral edge of the shunting element 1810. As shown in FIG. 18, the hexagonal wall structures 1852 can be positioned within and / or beyond the boundary wall structures 1854. The separation distance D 13 betw een the boundary wall structures 1854 and the lateral side edges of the shunting element 1810 can be between 10-300 pm or between 50-120 pm, such as 87 pm or 106 pm. Moreover, separation distance can be different on different sides of the shunting element 1810, and / or can vary along a length of a single side of the shunting element 1810. Regardless, these dimensions can correspond to the lengths of the outflow wall structures 1856 extending laterally from the boundary wall structures 1854 to the sides of the shunting element 1810. The separation distance D14 between the boundary' wall structures 1854 and the bottom (e.g., distal) edge of the shunting element 1810 can be between 100-300 pm or between 150-200 pm, such as 167 pm or 173 pm. This dimension can correspond to the length of the outflow wall structure 1856 extending from the boundary wall structures 1854 to the bottom (e g., distal end) of the shunting element 1810.

[0062] The height of the wall structures of the microtexturing pattern 1850 can be between20-70 pm, or between 25-60 pm, or between 30-50 pm, or between 35-45 pm, such as 38 pm or 40 pm. The roughness average (Ra) (e.g., the arithmetic average of the surface height deviations measured from the mean plane) of the wall structures can be between 3-12, or between 4-11, or between 5-10, or about 6, about 7, about 8, or about 9. The skewness (Rsk) (e.g., the asymmetry of the surface height distribution) of the wall structures can be between - 0.5 and 1.5. The kurtosis (Rku) (e.g.. the sharpness of the surface height distribution) of the wall structures can be between 1-3.5, or between 1.5-3.0, or between 2.0-2.5. The peak density of the wall structures can be between 30-300 per mm2, or between 30-40 per mm2, or between 70- 90 per mm2, or between 250-290 per mm2. The total surface area occupied by the microtexturing pattern 1850 can be between 1-3 mm2, such as about 1.5 mm2, 2.0 mm2, or 2.5 mm2. As one skilled in the art will appreciate, the foregoing ranges are provided by way of example only — embodiments of the present technology can include dimensions and values outside of the foregoing ranges.

[0063] The microtexturing pattern 1850 can cover various portions of an outer facing surface of the shunting system 1800. For example, FIG. 19 is an enlarged top view of a portion of a shunting system 1900 with the microtexturing pattern 1850 of FIG. 18 in a first arrangement and configured in accordance with an embodiment of the present technology. In the illustrated embodiment, a boundary' wall structure 1954 extends laterally across the shunting element 1810 and is positioned between the suture holes (not shown) and the distal end portion of the shunting system 1900. The microtexturing pattern 1850 (e.g., including the plurality of hexagonal wall structures 1852) is positioned on the distal end portion of the shunting system 1900 without extending past the boundary wall structure 1954. As another example, FIG. 20 is an enlarged top view of a portion of a shunting system 2000 with the microtexturing pattern 1850 of FIG. 18 in a second arrangement different than the first arrangement and configured in accordance with an embodiment of the present technology. In the illustrated embodiment, a pair of boundary wall structures 2054 extend generally circumferentially around and spaced apart from corresponding ones of suture holes 2008a and 2008b. The separation distance D15 between one of the boundary wall structure 2054 and the corresponding suture hole 2008a or 2008b can be between 200-600 pm, such as about 400 pm. The microtexturing pattern 1850 (e.g., including the plurality of hexagonal wall structures 1852) can be positioned on the distal end portion and along the center line of the shunting system 2000 without extending past the boundary wall structures 2054. Relative to the first arrangement shown in FIG. 19, the second arrangement in FIG. 20 has themicrotexturing patern 1850 covering a greater portion of an entire surface area of the shunting element 1810.

[0064] Indeed, in some embodiments the microtexturing surface 1850 can cover between about 10% and about 90%, or between about 10% and about 75%, or between about 20% and about 50%, or between about 20% and about 30% of the entire externally facing surface area of the shunting element. In some embodiments, the microtexturing surface 1850 is located on multiple surfaces of the shunting element, such as both top (e.g., upward facing when implanted) and botom (e.g., downward facing when implanted) surfaces. In other embodiments, the microtexturing surface 1850 can be limited to a single surface (e.g., only the upward facing surfacing when the system is implanted).

[0065] Referring to FIGS. 18-20 together, in operation, the microtexturing patern 1850 can help control a bio-response in the bleb. For example, the various wall structures of the microtexturing patern 1850 can be shaped and sized to permit fibroblasts move between the individual wall structures. In some embodiments, the wall structures are small enough for fibroblasts to slide across the wall structures, while simultaneously reducing the likelihood of multiple fibroblasts linking together to form fibrotic tissue over the shunting element. Thus, the microtexturing patern 1850 is expected to reduce the likelihood of fibroblasts latching thereon and is therefore expected to interfere with fibrosis development and reduce eventual scarring in the bleb. The boundary wall structures generally define the boundaries that contain most if not all of the microtexturing patern 1850 on the shunting system. Therefore, the microtexturing pattern 1850 can be limited to localized regions on the surface of the shunting system, inhibiting or deterring the growth of fibroblasts in those regions while allowing growth around other portions of the shunting system, such as around the suture holes.

[0066] As one skilled in the art will appreciate, FIGS. 2A-11 and 18-20 describe various examples of surface features, including microtexturing paterns and protrusions and recesses that can be formed in one, two, three, or more layers and at various densities, that can be incorporated into a shunting system to interfere with fibroblasts and inhibit fibrosis (and thus can be referred to as “antiproliferative surface features’"). However, the present technology is not limited to the surface features and textured surfaces expressly shown herein — in some embodiments, the surface features and textured / irregular surfaces can other paterns, shapes, and sizes beyond those expressly illustrated.C. Select Embodiments of Diffuse Outflow Arrays for use with Shunting Systems

[0067] In addition to or in lieu of having textured / irregular surfaces, in some embodiments the shunting systems described herein can other anti-proliferative features expected to reduce fibrotic growth. For example, the shunting systems described herein can have a diffuse outflow array or region that is expected to reduce the likelihood of fibroblasts or other cells adhering to, and / or growing around, the outflow region of the shunt by spreading flow out the device over a larger surface area. FIGS. 12A-15C illustrate various embodiments of shunting systems having diffuse outflow arrays.

[0068] FIGS. 12A-12C are enlarged top, see-through side, and see-through perspective views of a portion of a shunting system 1200 (“system 1200") combined with upward diffuse outflow region or array and configured in accordance with an embodiment of the present technology. The system 1200 can be an example of the system 100 illustrated in FIGS. 1A and IB (or another shunting system), and can include a shunting element 1202 with a first layer 1210, a second layer 1212, and a third layer 1214 (FIG. 12B) with a first channel 1204a, a second channel 1204b. and a third channel 1204c (collectively “channels 1204”). In other embodiments, the shunting element 1202 can include a different number of layers and / or channels 1204. As shown, the first layer 1210 can include a textured surface or mat 1220 (e.g., a mesh-like surface), which can include any of the textured surfaces and patterns described above with reference to FIGS. 2A-11. Additionally, the second layer 1212 can include a plurality of diffusion outflow channels 1230 extending from the channels 1204 and through the texture mat 1220. During operation of the system 1200, some of the fluid (e.g., aqueous) flowing in the channels 1204 can flow upward through the diffusion outflow' channels 1230 and out through the texture mat 1220, while some of the fluid continues to flow through the channels 1204 and out of a distal end of the system 1200. In some embodiments, the texture mat 1220 is a mesh-like feature formed by a plurality of interconnected ridges defining a plurality of openings that extend between upper and low er surfaces of the texture mat 1220. In such embodiments, the diffusion outflow7channels 1230 can terminate “under” the mesh, and the fluid can percolate up through the mesh via any of the openings formed between interconnected ridges. This is expected to further spread the outflow' of fluid across a larger surface area. Without intending to be bound by theory, spreading the outflow7of fluid over a larger surface area, particularly along an “upper” surface of the system 1200, is expected to disrupt fibroblast adhesion and fibrosis formation along the upper surface of the system 1200.

[0069] FIG. 13A is a top view of another shunting system 1300 (“system 1300”) with a microfluidic diffuse outflow array 1320 and that is configured in accordance with an embodiment of the present technology. FIG. 13B is an enlarged view of the microfluidic diffuse outflow array 1320. The system 1300 can be an example of the system 100 illustrated in FIGS. 1A and IB (or another shunting system), and can include a shunting element 1302 with a first end portion 1302a and a second end portion 1302b. The shunting element 1302 can include first channel 1304a, a second channel 1304b, and a third channel 1304c (collectively “channels 1304”) extending between the first and second end portions 1302a, 1302b. The shunting element 1302 can also include the microfluidic diffuse outflow array 1320 at the second end portion 1302b. Relative to the embodiment shown in FIGS. 12A-12C, the microfluidic diffuse outflow array 1320 is positioned at a distal end of the channels 1304 (e.g., as opposed to being positioned above the channels 1204 in FIGS. 12A-12C), such that all of the fluid flowing through the system 1300 flows out via the microfluidic diffuse outflow array 1320. As better shown in FIG. 13B, the microfluidic diffuse outflow array 1320 can include a continuous channel 1322 arranged in a grid-like pattern and fluidly coupled to each of the channels 1304. The grid-like pattern defines a lurality of openings or through-holes 1324 that are expected to disrupt fibroblast adhesion and fibrosis formation along the microfluidic diffuse outflow- array 1320. During operation of the system 1300, fluid (e.g., aqueous) flowing in the channels 1304 flows into the channel 1322 of the microfluidic diffuse outflow array 1320 before flowing out of the system 1300.

[0070] FIGS. 14A and 14B are top and perspective views, respectively of a bottom layer 1414 of a shunting system 1400 (“system 1400”) with another diffuse outflow array 1420 (which can also be referred to as a redundancy flow7network 1420) and that is configured in accordance with an embodiment of the present technology7. FIG. 14C is an enlarged view of the redundancy flow network 1420. The system 1400 can be an example of the system 100 illustrated in FIGS. 1A and IB (or another shunting system), and can include a shunting element 1402 with a first end portion 1402a and a second end portion 1402b. The shunting element 1402 can include a first channel 1404a, a second channel 1404b, and a third channel 1404c (collectively “channels 1404”) extending between the first and second end portions 1402a, 1402b. The shunting element 1402 can also include the redundancy flow network 1420 at the second end portion 1402b. As best shown in FIG. 14C, the redundancy flow network 1420 is defined by an increase in the number of fluid pathways or channels. For example, the redundancy flow network 1420 can include a first flow7channel 1422a fluidly coupled to the first channel 1404a, a second flow7channel 1422b fluidly coupled to the second channel 1404b, and a third flow channel 1422c fluidly coupled to the third channel 1404c (collectively "‘flow channels 1422”). Each of the flow channels 1422 can be arranged in various patterns (e.g., griddike) and the branches of the flow channels 1422 can spread the outflow of fluid across a larger surface area. FIG. 14C also illustrates various example dimensions across the redundancy flow network 1420, where the first number represents the dimension in millimeters and the second number represents the count of that dimension in the illustrated embodiment. For example, the redundancy flow network f420 includes a plurality of channels having a channel width of about 0.030 mm.

[0071] FIGS. 15A-15C are exploded, top, and cross-sectional views, respectively, of another shunting system 1500 having a diffuse outflow array and configured in accordance with an embodiment of the present technology. The shunting system 1500 can include a shunting element 1502 with a first end portion 1502a and a second end portion 1502b opposite the first end portion 1502a. The shunting element 1502 can include a first layer 1510, a second layer 1512, and a third layer 1514. The shunting system 1500 includes components and features generally similar to the shunting system 100 illustrated in FIGS. 1A and IB, wherein similar components are labeled with similar reference numbers. Discussion of such similar components is omitted.

[0072] The second end portions 1502b of each of the three layers 1510, 1512. 1514, however, differ from the second end portions 102b of the three layers 110. 112, 114 illustrated in FIG. IB. For example, the channels 1504 on the third layer 1514 do not extend through the end of the third layer 1514, but instead terminate prior to the end. In other embodiments, however, the channels 1504 can extend through the end of the third layer 1514. In some embodiments, the length of each of the channels 1504 can be about 4 mm, 6 mm, 8 mm, 10 mm, or more. Of note, the second layer 1512 includes a thinned section, platform, or membrane 1524 that has a first thickness that is less than a second thickness of a perimeter or margin of the second layer 1512. This defines a reservoir 1520 (e.g., an empty space or chamber) positioned between the platform 1524 and the first layer 1510 when the first layer 1510 and the second layer 1512 are adhered together. The second layer 1512 further includes an opening 1522 at the distal end of the platform 1524 and in fluid communication with the channels 1504 and the reservoir 1520. The first layer 1510 includes a mesh-like diffuse outflow array 1550 having a plurality' of apertures extending through and that is positioned above the reservoir 1520.

[0073] During operation of the shunting system 1500, fluid (e.g., aqueous) can flow through one or more of the channels 1504 from the first end portion 1502a to the second end portion 1502b. The fluid can then be directed through the opening 1522 and into the resen' oir 1520. The fluid can then flow out of the shunting element 1502 via the apertures in the diffuse outflow array 1550. The reservoir 1520 can provide additional volume within the shunting element 1502 to store the fluid and assist with spreading outflow across a greater surface area, similar to the diffuse outflow arrays described above. Without intending to be bound by theory, spreading outflow over a larger area may ( 1 ) reduce the impact that tissue ox ergrow th has on the shunting system (e.g., if some portion of the outflow array 1550 is encapsulated via fibrotic tissue, fluid can still flow' out of the shunting element in other locations,) (2) reduce fibrosis byinterfering with fibroblasts via the irregular surface of the outflow array 1550, and (3) provide continuous fluid flow around the outflow array 1550 to reduce the likelihood of fluid stagnation and tissue overgrowth.

[0074] In some embodiments, the reservoir 1520 can be filled with one or more antiproliferative therapeutics (e.g., mitomycin) prior to or after implantation of the shunting system 1500 in an eye. As fluid flows through the opening 1522 and out through the apertures in the diffuse outflow array 1550, the fluid can deliver the antiproliferative therapeutics to a portion of the eye, such as a bleb. The reservoir 1520 can also be filled with other substances.D. Select Embodiments of Shunting Systems with Increased Outflow Region Surface Areas

[0075] In addition to or in lieu of having surface features and / or diffuse outflow arrays to reduce fibrosis in the bleb, in some embodiments the shunting systems of the present technologycan include one or more anti-proliferative features that increase the surface area of the shunting system that is configured to be positioned in the bleb. For example, FIGS. 16A-16E are perspective, top, side cross-sectional, top cross-sectional, and bottom cross-sectional views, respectively, of a shunting system 1600 having a relatively large surface area at its outflow- end and that is configured in accordance with an embodiment of the present technology-. The shunting system 1600 can include a shunting element 1602 with a first end portion 1602a and an elongated second end portion 1602b (e g., an elongated outflow end portion). The elongated second end portion 1602b can be shaped to spiral inw ard, as shown, or have another non-linear shape that corresponds to a shape of the bleb. The spiral shape advantageously enables the second end portion 1602b to have a relatively large surface area while still fitting within the bleb. The system 1600 can optionally include an actuation assembly 1620 in the first end portion 1602a.

[0076] As shown in FIG. 16D, which is a cross-sectional view along plane D-D in FIG. 16C, the shunting system 1600 includes a diffuse outflow array having a plurality of apertures 1650 positioned along the length of the elongated second end portion 1602b. As shown in FIG. 16E, which is a cross-sectional view along plane E-E in FIG. 16C, the shunting system 1600 also includes channels 1604a, 1604b, 1604c (collectively “the channels 1604”) extending from the first end portion 1602a toward and along the elongated second end portion 1602b. The channels 1604 extend under the diffuse outflow array with the plurality of apertures 1650. In some embodiments, the apertures 1650 are directly fluidly coupled to the channels 1604, such that fluid can flow out of the shunting element via the plurality of outflow apertures 1650 anywhere along the length of the channels 1604, similar to the embodiment described above with reference to FIGS. 12A-12C. In other embodiments, however, the apertures 1650 are not directly fluidly coupled to the channels 1604, and instead fluid flows to a distal end of the channels 1604 and into a reservoir above the channels 1604 and under the apertures 1650 before the fluid can flow out of the system 1600, similar to the embodiment described above with reference to FIGS. 15A-15C. In some embodiments, the end of the elongated second end portion 1602b is sealed to prevent fluid outflow therefrom and to keep fluid outflow limited to the apertures 1650. In other embodiments, the end of the elongated second end portion 1602b is at least partially open to allow fluid outflow therefrom. Further, because the lengths of the channels 1604 are greater compared to. for example, the lengths of the channels 1504 illustrated in FIG. 15 A, a cross- sectional area of each channel 1604 can be increased while maintaining a comparable fluid resistance. This may advantageously reduce the likelihood of a channel 1604 from being block by cellular debris. Without intending to be bound by theory, increasing the surface area of the of system 1600 that is positioned within the bleb may reduce the likelihood that fibrosis overgrows the entire outflow region of the system.

[0077] The system 1600 is designed to be able to transition between a linear delivery configuration and the spiral deployed configuration. For example, in some embodiments, the shunting system 1600 can be implanted in an eye via a needle or other delivery device having an elongated shaft. In such embodiments, the elongated second end portion 1602b can be straightened out to have a linear form factor (e.g., the delivery' configuration) when loaded into the needle. Upon deployment from the needle, the elongated second end portion 1602b can reassume the spiral shape (e.g., the deployed configuration). In some embodiments, the shunting element 1602 can be made from silicone (e.g., via a spiral-shaped mold), nitinol, and / or otherelastic materials such that the elongated second end portion 1602b automatically returns to the illustrated spiral shape when deployed from the needle.

[0078] FIGS. 17A-17E are perspective, top, side cross-sectional, top cross-sectional, and bottom cross-sectional views, respectively, of a shunting system 1700 configured in accordance with an embodiment of the present technology. The shunting system 1700 can include a shunting element 1702 with a first end portion 1702a and an enlarged second end portion 1702b (e.g., an enlarged outflow end portion). The enlarged second end portion 1702b can be toroid or annular shaped with a central gap 1752, although in other embodiments the enlarged second end portion 1702b can be circular (e.g., a solid circle), rectangular, or otherwise shaped. The system 1700 can optionally include an actuation assembly 1720 in the first end portion 1702a.

[0079] Similar to the system 1600 described with reference to FIGS. 16A-16E and as best shown in FIG. 17D, the shunting system 1700 includes a diffuse outflow array having a plurality of apertures 1750 positioned along a length of the enlarged second end portion 1702b. As shown in FIG. 17E, the system 1700 further includes a plurality of channels 1704a, 1704b, and 1704c (collectively, “the channels 1704”) that form a spiral pattern at the second end portion 1702b. The channels 1704 extend under the diffuse outflow array with the plurality of apertures 1750. In some embodiments, the apertures 1750 are directly fluidly coupled to the channels 1704, such that fluid can flow out of the shunting element via the plurality of outflow apertures 1750 anywhere along the length of the channels 1704. similar to the embodiment descnbed above with reference to FIGS. 12A-12C. In other embodiments, however, the apertures 1750 are not directly fluid coupled to the channels 1704, and instead fluid flows to a distal end of the channels 1704 and into a reservoir above the channels 1704 and under the apertures 1750 before the fluid can flow out of the system 1700, similar to the embodiment described above with reference to FIGS. 15A-15C. Further, because the lengths of the channels 1704 are greater compared to, for example, the lengths of the channels 1504 illustrated in FIG. 15A, a cross-sectional area of each channel 1704 can be increased while maintaining a comparable fluid resistance. This may advantageously reduce the likelihood of a channel 1704 from being block by biological or other debris. Without intending to be bound by theory, increasing the surface area of the of system 1700 that is positioned within the bleb may reduce the likelihood that fibrosis overgrows the entire outflow region of the system.

[0080] In some embodiments, the shunting system 1700 can be folded or collapsed prior to implantation in an eye. The central gap 1752 can enable the shunting system 1700 to be foldedmore easily into a low-profile delivery configuration, e.g., to enable the system 1700 to be implanted through a relatively smaller incision in the eye. In some embodiments, the shunting element 1702 can be made from silicone (e.g., via a spiral-shaped mold), nitinol, and / or other materials such that the enlarged second end portion 1702b automatically returns to the illustrated shape after being folded and deployed in the eye.

[0081] A person skilled in the art will appreciate that certain embodiments of the technology disclosed herein can be combined in a single shunting system. For example, each of the shunting systems 1500, 1600, 1700 can include a textured surface (e.g.. the textured surface 150 illustrated in FIGS. 1A and IB) in addition to the apertures 1550, 1650, 1750.

[0082] Examples

[0083] Several aspects of the present technology are set forth in the following examples.1. A glaucoma shunting system for shunting fluid from a first region in a patient’s eye to a second region in the patient’s eye, the system comprising: a shunting element including a first end portion and a second end portion opposite the first end portion, wherein the shunting element is sized and shaped such that, when the system is implanted in the patient’s eye, the first end portion is positioned at least partially within the first region of the patient’s eye and the second end portion is positioned at least partially within the second region of the patient’s eye; and anti-proliferative features on and / or defining at least a portion of the second end portion of the shunting element, wherein the anti-proliferative features include a plurality of protrusions and / or recesses, with at least some of the plurality of protrusions and / or recesses having different dimensions.2. The glaucoma shunting system of example 1 wherein the anti-proliferative features comprise: a first layer including a plurality of first projections; and a second layer including a plurality of second projections. wherein at least some of the first projections have different dimensions than at least some of the second projections.3. The glaucoma shunting system of example 1 or example 2 wherein the antiproliferative features are arranged in a random pattern.4. The glaucoma shunting system of example 1 or example 2 wherein the antiproliferative features are arranged in a repeating pattern.5. The glaucoma shunting system of any of examples 1-4 wherein the shunting element comprises a microfluidic diffuse outflow array on and / or defining at least a portion of the second end portion, wherein the microfluidic diffuse outflow array includes a plurality of apertures extending through an outer surface of the shunting element.6. The glaucoma shunting system of example 5 wherein the shunting element includes a reservoir beneath the microfluidic diffuse outflow array.7. The glaucoma shunting system of any of examples 1-6 wherein the second end portion is configured to have an elongated spiral shape and / or an enlarged annular shape when the shunting system is implanted within the patient.8. The glaucoma shunting system of any of examples 1-7 wherein the antiproliferative features are integral with the shunting element.9. A method of manufacturing a glaucoma shunt having anti-proliferative features, the method comprising: coupling a first layer and a second layer together to form the anti-proliferative features, wherein the first layer includes a first plurality of features with a first density, and wherein the second layer includes a second plurality of features with a second density, different than the first density, such that the anti-proliferative features includes the first features and the second features combined at a third density that is greater than the first density and the second density.10. The method of example 8, further comprising coupling a third layer to the second layer, wherein the third layer includes a third plurality of features at a fourth density, wherein the anti-proliferative features further comprise the third plurality of features.11. The method of example 8 or example 9 wherein the anti-proliferative features comprise a plurality of protrusions and / or recesses arranged in a random pattern.12. The method of any of examples 8-10 wherein each of the first and second pluralities of features has a density between 10 per millimeters squared and 40 per millimeters squared.13. The method of any of examples 8-11 wherein individual ones of the first and second pluralities of features comprise protrusions with heights that range between 10 microns and 50 microns.14. The method of any of examples 8-12 wherein the glaucoma shunt comprises a first end portion and an elongated second end portion opposite the first end portion, wherein the elongated second end portion has a spiraling shape.15. The method of any of examples 8-13 wherein the glaucoma shunt comprises a first end portion and an enlarged second end portion opposite the first end portion, wherein the enlarged second end portion includes a central gap.16. A glaucoma shunting system for shunting fluid from a first region in a patient’s eye to a second region in the patient’s eye, the system comprising: a shunting element including a first end portion and a second end portion opposite the first end portion, wherein the shunting element is sized and shaped such that, when the system is implanted in the patient’s eye, the first end portion is positioned at least partially within the first region of the patient’s eye and the second end portion is positioned at least partially within the second region of the patient’s eye; and anti-proliferative features on at least a portion of the second end portion of the shunting element, wherein the anti-proliferative features include a plurality of wall structures arranged in an array across a portion of the second end portion and configured to deter growth of fibroblasts thereon.17. The glaucoma shunting system of example 16 wherein individual wall structures of the plurality of wall structures have a lateral dimension between 10-50 microns.18. The glaucoma shunting system of example 16 or example 17 wherein the wall structures have a height of between 30-50 microns.19. The glaucoma shunting system of any of examples 16-18 wherein the plurality of wall structures are hexagonal-shaped.20. The glaucoma shunting system of any of examples 16-19 wherein the plurality of wall structures are arranged in a repeating pattern with consistent spacing between individual wall structures.21. The glaucoma shunting system of any of examples 16-20 wherein the plurality of wall structures include: one or more boundary wall structures extending along and spaced apart from an edge of the second end portion of the shunting element, wherein the one or more boundary wall structures are spaced apart from the edge of the second end portion of the shunting element by a dimension between 10-300 pm; and one or more outflow wall structures extending laterally from the one or more boundary wall structures to the edge of the second end portion of the shunting element.22. The glaucoma shunting system of any of examples 16-21 wherein the shunting element includes a pair of suture holes between the first end portion and the second end portion, and wherein the plurality' of wall structures include a boundary' wall structure extending laterally across a region of the shunting element between the pair of suture holes and the second end portion.23. The glaucoma shunting system of any of examples 16-22 wherein the shunting element includes a pair of suture holes between the first end portion and the second end portion, and wherein the plurality of wall structures include a pair of boundary wall structures extending along and spaced apart from corresponding ones of the suture holes.24. The glaucoma shunting system of any of examples 16-23 wherein the plurality of wall structures have at least one of the following features: a height between 30-50 pm; a roughness average (Ra) between 3-12; a skewness (Rsk) between -0.5 and 1.5; a kurtosis (Rku) between 1-3.5; a peak density between 30-300 per mm2; or a total surface area between 1-3 mm2.25. A glaucoma shunting system for shunting fluid from a first region in a patient's eye to a second region in the patient's eye, the system comprising: a shunting element including a first end portion and a second end portion opposite the first end portion, wherein the shunting element is sized and shaped such that, when the system is implanted in the patient's eye, the first end portion is positioned at least partially within the first region of the patient's eye and the second end portion is positioned at least partially within the second region of the patient’s eye, and wherein the second end portion includes: one of more flow channels configured to receive fluid from the first end portion of the shunting element, a diffuse outflow array having a plurality of outflow openings, and a reservoir positioned fluidically between the one or more flow channels and the diffuse outflow array such that fluid collects in the reservoir before flowing out of the plurality of outflow openings.26. The glaucoma shunting system of example 25 wherein the shunting element includes a first surface and a second surface opposite the first surface, and wherein: the reservoir is between the first surface and the second surface, and the plurality of outflow openings are positioned on the first surface.27. The glaucoma shunting system of example 26 wherein the first surface is configured to be positioned closer to an outer surface of the patient’s eye than the second surface when the shunting system is implanted in the patient.28. The glaucoma shunting system of any of examples 25-27 wherein the shunting element comprises a first layer, a second layer, and a third layer, and wherein: the diffuse outflow array is defined by the first layer, the reservoir is defined by the second layer, and the one or more flow channels are defined by the third layer.29. The glaucoma shunting system of any of examples 25-28 wherein the shunting element further comprising anti-proliferative features including projections and / or recesses.30. The glaucoma shunting system of example 29 wherein the anti-proliferative features include projections formed by wall structures.31. The glaucoma shunting system of example 30 wherein the wall structures have a lateral dimension of between 10-50 microns and a height of between 30-50 microns.Conclusion

[0084] The above detailed descriptions of embodiments of the technology7are not intended to be exhaustive or to limit the technology to the precise form disclosed above. Although specific embodiments of, and examples for, the technology7are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology, as those skilled in the relevant art will recognize. While steps are presented in a given order, alternative embodiments may perform steps in a different order. Moreover, the various embodiments described herein may also be combined to provide further embodiments. Reference herein to "one embodiment." "an embodiment," or similar formulations means that a particular feature, structure, operation, or characteristic described in connection with the embodiment can be included in at least one embodiment of the present technology7. Thus, the appearances of such phrases or formulations herein are not necessarily all referring to the same embodiment.

[0085] For ease of reference, identical reference numbers are used to identify similar or analogous components or features throughout this disclosure, but the use of the same reference number does not imply that the features should be construed to be identical. Indeed, in many examples described herein, identically numbered features have a plurality of embodiments that are distinct in structure and / or function from each other. Furthermore, the same shading may beused to indicate materials in cross section that can be compositionally similar, but the use of the same shading does not imply that the materials should be construed to be identical unless specifically noted herein.

[0086] Moreover, unless the word "or" is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of "or" in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Where the context permits, singular or plural terms may also include the plural or singular term, respectively. Additionally, the term "comprising" is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and / or additional types of other features are not precluded. Directional terms, such as "upper," "lower," "front," "back," "vertical," and "horizontal," may be used herein to express and clarify the relationship between various elements. It should be understood that such terms do not denote absolute orientation. Further, while advantages associated with certain embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology'. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.

Claims

CLAIMSI / We claim:

1. A glaucoma shunting system for shunting fluid from a first region in a patient's eye to a second region in the patient's eye, the system comprising: a shunting element including a first end portion and a second end portion opposite the first end portion, wherein the shunting element is sized and shaped such that, when the system is implanted in the patient’s eye, the first end portion is positioned at least partially within the first region of the patient’s eye and the second end portion is positioned at least partially within the second region of the patient’s eye; and anti-proliferative features on and / or defining at least a portion of the second end portion of the shunting element, wherein the anti-proliferative features include a plurality of protrusions and / or recesses, with at least some of the plurality of protrusions and / or recesses having different dimensions.

2. The glaucoma shunting system of claim 1 wherein the anti-proliferative features comprise: a first layer including a plurality of first projections; and a second layer including a plurality of second projections, wherein at least some of the first projections have different dimensions than at least some of the second projections.

3. The glaucoma shunting system of claim 1 wherein the anti-proliferative features are arranged in a random pattern.

4. The glaucoma shunting system of claim 1 wherein the anti-proliferative features are arranged in a repeating pattern.

5. The glaucoma shunting system of any of claim 1 wherein the shunting element comprises a microfluidic diffuse outflow array on and / or defining at least a portion of the secondend portion, wherein the microfluidic diffuse outflow array includes a plurality of apertures extending through an outer surface of the shunting element.

6. The glaucoma shunting system of claim 5 wherein the shunting element includes a reservoir beneath the microfluidic diffuse outflow array.

7. The glaucoma shunting system of claim 1 wherein the second end portion is configured to have an elongated spiral shape and / or an enlarged annular shape when the shunting system is implanted within the patient.

8. The glaucoma shunting system of claim 1 wherein the anti-proliferative features are integral with the shunting element.

9. A method of manufacturing a glaucoma shunt having anti-proliferative features, the method comprising: coupling a first layer and a second layer together to form the anti-proliferative features, wherein the first layer includes a first plurality of features with a first density, and wherein the second layer includes a second plurality of features with a second density, different than the first density, such that the anti-proliferative features includes the first features and the second features combined at a third density that is greater than the first density7and the second density7.

10. The method of claim 9, further comprising coupling a third layer to the second layer, wherein the third layer includes a third plurality of features at a fourth density, wherein the anti-proliferative features further comprise the third plurality7of features.

11. The method of claim 9 wherein the anti-proliferative features comprise a plurality of protrusions and / or recesses arranged in a random pattern.

12. The method of claim 9 wherein each of the first and second pluralities of features has a density between 10 per millimeters squared and 40 per millimeters squared.

13. The method of claim 9 wherein individual ones of the first and second pluralities of features comprise protrusions with heights that range between 10 microns and 50 microns.

14. The method of claim 9 wherein the glaucoma shunt comprises a first end portion and an elongated second end portion opposite the first end portion, wherein the elongated second end portion has a spiraling shape.

15. The method of claim 9 wherein the glaucoma shunt comprises a first end portion and an enlarged second end portion opposite the first end portion, wherein the enlarged second end portion includes a central gap.

16. A glaucoma shunting system for shunting fluid from a first region in a patient’s eye to a second region in the patient’s eye, the system comprising: a shunting element including a first end portion and a second end portion opposite the first end portion, wherein the shunting element is sized and shaped such that, when the system is implanted in the patient’s eye, the first end portion is positioned at least partially within the first region of the patient’s eye and the second end portion is positioned at least partially within the second region of the patient’s eye; and anti-proliferative features on at least a portion of the second end portion of the shunting element, wherein the anti-proliferative features include a plurality of wall structures arranged in an array across a portion of the second end portion and configured to deter growth of fibroblasts thereon.

17. The glaucoma shunting system of claim 16 wherein individual wall structures of the plurality' of wall have a lateral dimension between 10-50 microns.

18. The glaucoma shunting system of claim 16 wherein the wall structures have a height of between 30-50 microns.

19. The glaucoma shunting system of claim 16 wherein the plurality of wall structures are hexagonal-shaped.

20. The glaucoma shunting system of claim 16 wherein the plurality of wall structures are arranged in a repeating pattern with consistent spacing between individual wall structures.

21. The glaucoma shunting system of claim 16 wherein the plurality of wall structures include: one or more boundary wall structures extending along and spaced apart from an edge of the second end portion of the shunting element, wherein the one or more boundary7wall structures are spaced apart from the edge of the second end portion of the shunting element by a dimension between 10-300 pm; and one or more outflow wall structures extending laterally from the one or more boundary wall structures to the edge of the second end portion of the shunting element.

22. The glaucoma shunting system of claim 16 wherein the shunting element includes a pair of suture holes between the first end portion and the second end portion, and wherein the plurality of wall structures include a boundary wall structure extending laterally across a region of the shunting element between the pair of suture holes and the second end portion.

23. The glaucoma shunting system of claim 16 wherein the shunting element includes a pair of suture holes between the first end portion and the second end portion, and wherein the plurality of wall structures include a pair of boundary wall structures extending along and spaced apart from corresponding ones of the suture holes.

24. The glaucoma shunting system of claim 16 wherein the plurality of wall structures have at least one of the following features: a height between 30-50 pm; a roughness average (Ra) between 3-12; a skewness (Rsk) between -0.5 and 1.5; a kurtosis (Rku) between 1-3.5; a peak density' between 30-300 per mm2; or a total surface area between 1-3 mm2.

25. A glaucoma shunting system for shunting fluid from a first region in a patient's eye to a second region in the patient's eye, the system comprising: a shunting element including a first end portion and a second end portion opposite the first end portion, wherein the shunting element is sized and shaped such that, when the system is implanted in the patient’s eye, the first end portion is positioned at least partially within the first region of the patient’s eye and the second end portion is positioned at least partially within the second region of the patient’s eye, and wherein the second end portion includes: one of more flow channels configured to receive fluid from the first end portion of the shunting element, a diffuse outflow array having a plurality of outflow openings, and a reservoir positioned fluidically between the one or more flow channels and the diffuse outflow array such that fluid collects in the reservoir before flowing out of the plurality of outflow openings.

26. The glaucoma shunting system of claim 25 wherein the shunting element includes a first surface and a second surface opposite the first surface, and wherein: the reservoir is between the first surface and the second surface, and the plurality’ of outflow openings are positioned on the first surface.

27. The glaucoma shunting system of claim 26 wherein the first surface is configured to be positioned closer to an outer surface of the patient’s eye than the second surface when the shunting system is implanted in the patient.

28. The glaucoma shunting system of claim 25 wherein the shunting element comprises a first layer, a second layer, and a third layer, and wherein: the diffuse outflow array is defined by the first layer, the reservoir is defined by the second layer, and the one or more flow channels are defined by the third layer.

29. The glaucoma shunting system of claim 25 wherein the shunting element further comprising anti-proliferative features including projections and / or recesses.

30. The glaucoma shunting system of claim 29 wherein the anti-proliferative features include projections formed by wall structures.

31. The glaucoma shunting system of claim 30 wherein the wall structures have a lateral dimension of between 10-50 microns and a height of between 30-50 microns.

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