Adjustable flow glaucoma shunts and methods for making and using same

Abstract

To provide adjustable flow glaucoma shunts and methods for making and using the same.SOLUTION: An adjustable flow shunt can include an outflow drainage tube having a proximal inflow region and a distal outflow region. The proximal inflow region can include aperture(s) defining a fluid inlet area positioned to allow fluid to flow therethrough. The shunt further comprises an inflow control assembly at the proximal inflow region. The inflow control assembly can include a control element configured to slidably engage the proximal inflow region and a spring element. The spring element is configured to be activated by non-invasive energy and, upon activation, slidably move the control element along the proximal inflow region such that (a) the one or more apertures are accessible and have a first fluid flow cross-section or (b) the one or more apertures are at least partially covered by the control element and have a second, different fluid-flow cross section.SELECTED DRAWING: Figure 3A

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 643,125, filed March 14, 2018, U.S. Provisional Patent Application No. 62 / 626,615, filed February 5, 2018, and U.S. Provisional Patent Application No. 62 / 535,125, filed July 20, 2017, the contents of which are incorporated herein by reference in their entireties.

[0002] The present technology relates to adjustable flow glaucoma shunts and methods of making and using such devices. [Background technology]

[0003] Glaucoma, or ocular hypertension, is a disease associated with increased intraocular pressure due to increased production of aqueous humor and / or a decreased rate of aqueous humor outflow from the eye into the bloodstream. Aqueous humor is produced in the ciliary body at the junction of the posterior and anterior chambers of the eye. It drains into the anterior chamber and ultimately into the capillary bed in the sclera of the eye. Glaucoma usually results from an impairment of the mechanism that transports aqueous humor from the eye into the bloodstream.

[0004] For example, if normal aqueous humor production is approximately 2.5 μL / min and the minimum pressure that can exist in the capillary bed through which aqueous humor drains is assumed to be 0 Torr, the maximum outflow resistance in a normal eye at maximum normal pressure is expected to be approximately 9 Torr / (μL / min). Normal pressure within the eye ranges from 12 to 22 Torr. As noted above, glaucoma is typically associated with high pressure within the eye, which can damage ocular tissue and cause vision loss. A condition in which pressure falls significantly below this range is called hypotony (or ocular hypotension). In some patients, hypotony can be just as (if not more) damaging as glaucoma.

[0005] Early stages of glaucoma are usually treated with medication. However, when medication is insufficient, surgical approaches are used. Surgical or minimally invasive approaches primarily attempt to reduce the resistance to aqueous humor outflow from the anterior chamber to the bloodstream by creating alternative fluid pathways or enhancing the natural pathways for aqueous humor outflow.

[0006] Devices used to reduce outflow resistance are commonly referred to as "glaucoma shunts" or "shunts." For example, FIGS. 1A-1C show several different conventional glaucoma plate shunts 100 (individually identified as 100a-c) configured to provide a constant resistance to flow. Shunt 100a in FIG. 1A includes, for example, plate 103a, multiple outflow ports 102a, one or more inflow ports 101, and a tie-down or engagement mechanism 104a. Shunts 100b and 100c, shown in FIGS. 1B and 1C, respectively, include several features similar to those of shunt 100a. For example, these shunts 100b-c include plates 103b-c, outflow ports 102b-c, and tie-down or engagement mechanisms 104b-c. However, shunts 100b-c include an inflow tube 105 instead of the inflow port 101 of shunt 100a.

[0007] 2A and 2B illustrate a human eye E and suitable locations where shunts 100a-c may be implanted within the eye. More specifically, FIG. 2A is a simplified front view of eye E, and FIG. 2B is an isometric view of the optic vesicle of FIG. 2A. Referring initially to FIG. 2A, eye E includes several muscles for controlling its movement, including the superior rectus muscle SR, the inferior rectus muscle IR, the lateral rectus muscle LR, the medial rectus muscle MR, the superior oblique muscle SO, and the inferior oblique muscle IO. Eye E also includes an iris, a pupil, and a limbus.

[0008] 2A and 2B together, the shunt 100c is positioned such that the inflow lumen 105 is located in the anterior chamber of the eye and the outflow port 102c is located at a different location within the eye. Depending on the device design, the outflow port 102c can be located at several different suitable outflow locations (e.g., between the choroid and sclera, between the conjunctiva and sclera). For illustrative purposes, only the shunt 100c implanted in eye E is shown. However, it will be understood that the shunts 100a-b may be similarly implanted within eye E.

[0009] Outflow resistance typically depends on the outflow location. Furthermore, after surgical implantation of the device, outflow resistance changes over time as the outflow location undergoes its healing process. Because outflow resistance changes over time, in many procedures, the shunt 100a-c is modified at the time of implantation to temporarily increase outflow resistance. After a period deemed sufficient to allow tissue healing and stabilization of outflow resistance, the modifications to the shunt 100a-c are reversed, thereby decreasing outflow resistance. Such modifications can be invasive, time-consuming, and expensive for the patient. However, failure to follow such procedures increases the likelihood of developing hypotony and its resulting problems. Summary of the Invention [Means for solving the problem]

[0010] The present technology relates to adjustable flow glaucoma shunts and methods of manufacturing and using such devices. In many of the embodiments disclosed herein, the adjustable flow glaucoma shunts include an adjustable fluidic resistor ("resistor" within the context of this document refers to a fluidic resistor), actuator, and / or actuation mechanism. In addition, in certain embodiments, the shunt may also include an adjustable opening pressure control mechanism. These mechanisms may be selectively adjusted or regulated to increase or decrease the outflow resistance and / or opening pressure of the shunt in response to changes in either (or any combination of) intraocular pressure (IOP), aqueous humor production rate, natural aqueous humor outflow resistance and / or natural aqueous humor outflow rate. The present invention provides, for example, the following. (Item 1) 1. An adjustable flow shunt for treating glaucoma in a human patient, said shunt comprising: an elongated outflow drainage tube having a proximal inflow region and a distal outflow region; an inflow control assembly in the proximal inflow region, a control element sized and shaped to slidably engage the proximal inflow region; and an inflow control assembly comprising a spring element operably coupled between the control element and an anchor element engaged to the proximal inflow region; the proximal inflow region includes one or more openings defining a fluid inlet area positioned to allow fluid to flow therethrough into the outflow drainage conduit; An adjustable flow shunt, wherein the spring element is configured to be activated by non-invasive energy and, upon activation, slidably actuates the control element along the proximal inflow region so that (a) the one or more openings are accessible and have a first fluid flow cross-section, or (b) the one or more openings are at least partially covered by the control element and have a second fluid flow cross-section that is smaller than the first fluid flow cross-section. (Item 2) 2. The adjustable flow shunt of item 1, wherein the proximal inflow region comprises a core element operably connected to and extending from the proximal end of the outflow drainage tube, and wherein the one or more openings extend through a sidewall of the core element to define the fluid inlet area. (Item 3) 3. The adjustable flow shunt of item 2, wherein the core element is constructed of a different material than the outflow drainage tube. (Item 4) Item 3. The adjustable flow shunt of item 2, wherein the core element is constructed from a first material having a first stiffness, and the outflow drainage tube is constructed from a second material having a second stiffness that is less than the first stiffness. (Item 5) 3. The adjustable flow shunt of item 2, wherein the core element is constructed from polyetheretherketone (PEEK), acrylic, polycarbonate, metal, ceramic, quartz, and / or sapphire. (Item 6) Item 10. The adjustable flow shunt of item 1, wherein the elongated outflow drainage tube is constructed from silicone and / or urethane. (Item 7) Item 10. The adjustable flow shunt of item 1, wherein the spring element is constructed of a shape memory material. (Item 8) Item 10. The adjustable flow shunt of item 1, wherein the spring element is constructed from nitinol. (Item 9) Item 10. The adjustable flow shunt of item 1, wherein the inflow control assembly is configured for placement within the anterior chamber in a region outside the optical field of the eye. (Item 10) 10. The adjustable flow shunt of item 9, wherein the outflow drainage tube is sized and shaped to traverse the interchamber region of the eye to a region in a suprachoroidal position. (Item 11) 10. The adjustable flow shunt of item 9, wherein the outflow drainage tube is sized and shaped to traverse the anterior interchamber region of the eye to a subconjunctival position. (Item 12) Item 10. The adjustable flow shunt of item 1, wherein the one or more openings comprise a single elongated slot extending axially along the proximal inflow region. (Item 13) Item 10. The adjustable flow shunt of item 1, wherein the one or more openings include a plurality of openings extending radially around the proximal inflow region. (Item 14) Item 10. The adjustable flow shunt of item 1, wherein the one or more openings include a plurality of openings extending spirally around the proximal inflow region. (Item 15) Item 10. The adjustable flow shunt of item 1, wherein the spring element is configured for activation via laser energy. (Item 16) the spring element comprises a first spring, the anchor comprises a first anchor, the first spring and the first anchor are disposed on a first side of the control element, and the inflow control assembly further comprises: a second spring and a corresponding second anchor on a second opposite side of the control element; 2. The adjustable flow shunt of claim 1, wherein the first and second spring elements are configured to be selectively activated by non-invasive energy, and upon activation, slidably move the control element in a first direction or a second direction, respectively, along the proximal inflow region so that (a) the one or more openings have the first fluid flow cross-section, or (b) the one or more openings are at least partially covered by the control element and have the second fluid flow cross-section that is smaller than the first fluid flow cross-section. (Item 17) Item 17. The adjustable flow shunt of item 16, wherein the first and second spring elements are configured, when activated, to slidably move the control element along the proximal inflow region so that the one or more openings are completely covered and inaccessible. (Item 18) Item 10. The adjustable flow shunt of item 1, wherein the spring element and corresponding anchor element are disposed at the proximal end of the control element between the control element and the outflow drainage tube. (Item 19) Item 10. The adjustable flow shunt of item 1, wherein the spring element comprises one or more coil springs extending around the proximal inflow region. (Item 20) Item 10. The adjustable flow shunt of item 1, wherein the spring element comprises one or more elongated arcuate springs extending between the control element and the anchor element. (Item 21) 1. An adjustable flow shunt assembly for the treatment of glaucoma, the shunt assembly comprising: an elongated drainage tube having a proximal portion and a distal portion, the proximal portion including an inflow port configured to be in fluid communication with a fluid chamber of the patient's eye; a variable resistor assembly configured to selectively control fluid flow to the inlet port, The base part and an aperture plate supported by the base portion, the aperture plate having a plurality of first apertures therethrough; a standoff plate supported by and extending away from the aperture plate, the standoff plate having a plurality of second openings therethrough, the second openings aligned with corresponding first openings in the aperture plate; the variable resistor assembly comprising: a membrane disposed on and supported by the standoff plate, the membrane being positioned to sealably cover an open end of each of the second openings; During operation, a portion of the membrane over one or more second openings of the stand-off plate is configured to be selectively targeted and removed via non-invasive energy, thereby creating a fluid pathway from a patient's bodily fluid site through the accessible open end of the targeted second opening, through the corresponding first opening, and to a drainage tube, an adjustable flow shunt assembly. (Item 22) the first opening has a first cross-sectional dimension; Item 22. The adjustable flow shunt assembly of item 21, wherein the second opening has a second cross-sectional dimension that is greater than the first cross-sectional dimension. (Item 23) Item 22. The adjustable flow shunt assembly of item 21, wherein the first openings have the same cross-sectional dimension. (Item 24) Item 22. The adjustable flow shunt assembly of item 21, wherein the standoff plate is at least partially constructed from a hydrophobic material configured to be at least partially melted via non-invasive energy. (Item 25) Item 22. The adjustable flow shunt assembly of item 21, wherein the standoff plate is constructed at least in part from a wax material configured to be at least partially melted via non-invasive energy. (Item 26) Item 22. The adjustable flow shunt assembly of item 21, wherein the base portion of the variable resistor assembly, the aperture plate, and the standoff plate are separate, individual components operably coupled to one another. (Item 27) Item 22. The adjustable flow shunt assembly of item 21, wherein the standoff plate and the membrane are fabricated as a single, integral component composed of the same material. (Item 28) Item 22. The adjustable flow shunt assembly of item 21, wherein the aperture plate and the standoff plate are manufactured as a single, integral component constructed from the same material. (Item 29) the membrane further comprises a plurality of target indicia aligned with and corresponding to each of the second openings; 22. The adjustable flow shunt assembly of claim 21, wherein during operation, the non-invasive energy is delivered to corresponding target indicia on the membrane to selectively remove membrane material at the target locations. (Item 30) 1. An adjustable flow shunt for the treatment of glaucoma in a human patient, said adjustable flow shunt comprising: an elongated outflow tube having (a) a proximal inflow portion configured for placement within the anterior chamber of the patient's eye in a region outside the optical field of view, and (b) a distal outflow portion at a different location on the eye; an actuator disposed along the outlet conduit between the inlet and outlet portions, the actuator being deformable between an open position that allows fluid to flow through the outlet conduit and a resistive position that partially obstructs fluid flow through the outlet conduit; The adjustable flow shunt, wherein in operation, the actuator is movable between positions in response to non-invasive energy. (Item 31) Item 31. The adjustable flow shunt of item 30, wherein the actuator is configured to engage the outflow tube and partially obstruct fluid flow through the outflow tube at the resistance location by changing the diameter and / or cross-sectional shape of the outflow tube. (Item 32) Item 31. The adjustable flow shunt of item 30, wherein the actuator is movable between positions in response to laser energy. (Item 33) the outflow tube comprises a dual lumen tube having a first lumen for conveying fluid therethrough and a second lumen adjacent to and separated by the first lumen by a septum; the actuator includes one or more actuating elements disposed within the second lumen and configured to transform between an expanded state and an initial state in response to non-invasive energy; Item 31. The adjustable flow shunt of item 30, wherein in the expanded state, an actuation element engages the septum and pushes the septum toward the first lumen, reducing its cross-sectional dimension. (Item 34) Item 31. The adjustable flow shunt of item 30, wherein the actuator is configured to hold one of the open position or the resistive position without power. (Item 35) 1. An adjustable flow shunt comprising: an elongate outflow tube having a proximal inflow portion configured for placement at a first location within a patient's eye and a distal outflow portion at a second location on the eye spaced apart from the first location; the outflow tube comprising a dual lumen tube having a first lumen for conveying fluid therethrough and a second lumen adjacent to and fluidly isolated from the first lumen; a control fluid disposed within the second lumen; During operation, increasing the volume of control fluid within the second lumen reduces the cross-sectional dimension of the first lumen, thereby partially obstructing fluid flow through the first lumen; An adjustable flow shunt, wherein decreasing the volume of control fluid in the second lumen increases the cross-sectional dimension of the first lumen, thereby increasing fluid flow through the first lumen. (Item 36) Item 36. The adjustable flow shunt of item 35, wherein the elongated outflow tube comprises an elastomeric tube. (Item 37) 36. The adjustable flow shunt of item 35, further comprising a reservoir in fluid communication with the second lumen, wherein the volume of control fluid in the second lumen is varied by transferring control fluid to and / or from the reservoir. (Item 38) 36. The adjustable flow shunt of item 35, wherein the volume of control fluid in the second lumen is changed by transferring control fluid to and / or from the second lumen via a syringe. (Item 39) the first lumen being separated from the second lumen by a septum; increasing the volume of control fluid within the second lumen causes the diaphragm to move toward the first lumen, decreasing its cross-sectional dimension; Item 36. The adjustable flow shunt of item 35, wherein decreasing the volume of control fluid in the second lumen causes the septum to move away from the first lumen and increase its cross-sectional dimension. (Item 40) 1. A shunt for the treatment of glaucoma in a human patient, said shunt comprising: an elongated outflow drainage tube having a proximal inflow region and a distal outflow region; an inflow control assembly in the proximal inflow region; and a transition region along the outflow tubing between the inflow region and the outflow region, wherein during operation the transition region is deformable between a first, substantially linear delivery shape and a second shape different from the first shape to secure the shunt in a desired position in the eye. (Item 41) Item 41. The shunt of item 40, wherein the outflow drainage tube is configured to be delivered over a guidewire, and the transition region is configured to transform between the first delivery configuration and the second configuration upon removal of the guidewire. (Item 42) Item 41. The shunt of item 40, wherein the transition region is configured to transform between the first delivery shape and the second shape upon application of non-invasive energy to one or more selected regions of the transition region. (Item 43) Item 41. The shunt of item 40, wherein the transition region is configured to transform between the first delivery configuration and the second configuration in response to application of non-invasive laser energy to one or more selected regions of the transition region. (Item 44) Item 41. The shunt of item 40, wherein the second shape comprises a generally "L" shaped configuration. (Item 45) 1. A method of treating glaucoma in a human patient, said method comprising: placing a shunt in the patient's eye, the shunt comprising an elongate outflow drainage tube having a proximal inflow region in a first portion of the eye and a distal outflow region in a second, different portion of the eye; and moving a control assembly at the proximal inflow region from a first position to a second, different position to selectively control the flow of aqueous humor through the shunt, wherein the control assembly is actuated by non-invasive energy. (Item 46) Item 46. The method of item 45, wherein moving a control assembly in the proximal inflow region comprises actuating the control assembly via the non-invasive energy to slidably move a control element of the control assembly along the proximal inflow region so that (a) one or more openings in the proximal inflow region are accessible and have a first fluid flow cross-section, or (b) the one or more openings are at least partially covered by the control element and have a second fluid flow cross-section that is smaller than the first fluid flow cross-section. (Item 47) Item 47. The method of item 46, wherein the one or more openings comprise a single elongated slot extending axially along the proximal inflow region. (Item 48) Item 47. The method of item 46, wherein the one or more openings comprise a plurality of openings extending radially around the proximal inflow region. (Item 49) Item 46. The method of item 45, wherein moving a control assembly in the proximal inflow region comprises actuating the control assembly via the non-invasive energy to slidably move the control element of the control assembly along the proximal inflow region such that (a) the one or more openings in the proximal inflow region are accessible or (b) the one or more openings are completely covered and inaccessible. [Brief explanation of the drawings]

[0011] Many aspects of the present technology can be better understood with reference to the following drawings. Components in the drawings are not necessarily drawn to scale. Instead, emphasis has been placed on clearly illustrating the principles of the present technology. Additionally, while components may be shown as transparent in certain drawings, this is for clarity of illustration only and does not necessarily imply that the components are transparent. Components are also shown in schematic form.

[0012] [Figure 1A] 1 shows a conventional glaucoma plate shunt configured to provide a constant resistance to flow. [Figure 1B] 1 shows a conventional glaucoma plate shunt configured to provide a constant resistance to flow. [Figure 1C] 1 shows a conventional glaucoma plate shunt configured to provide a constant resistance to flow. [Figure 2A] 1 is a simplified front view of eye E having a shunt implanted therein; and [Figure 2B] FIG. 2B is an isometric view of the optic vesicle of FIG. 2A. [Figure 3A]1 illustrates an adjustable flow glaucoma shunt configured in accordance with one embodiment of the present technology. [Figure 3B] 1 illustrates an adjustable flow glaucoma shunt configured in accordance with one embodiment of the present technology. [Figure 3C] FIG. 3C is a partial schematic diagram of the ocular capsule of a human patient showing the adjustable flow glaucoma shunt of FIGS. 3A and 3B implanted within the ocular capsule. [Figure 3D] 10 shows an inflow region configured in accordance with an additional embodiment of the present technology; [Figure 3E] 10 shows an inflow region configured in accordance with an additional embodiment of the present technology; [Figure 4A] 1 shows an adjustable flow glaucoma shunt constructed in accordance with another embodiment of the present technology. [Figure 4B] 1 shows an adjustable flow glaucoma shunt constructed in accordance with another embodiment of the present technology. [Figure 4C] 1 shows an adjustable flow glaucoma shunt constructed in accordance with another embodiment of the present technology. [Figure 5A] 1 illustrates an inflow control assembly configured in accordance with an embodiment of the present technology. [Figure 5B] 1 illustrates an inflow control assembly configured in accordance with an embodiment of the present technology. [Figure 6A] 1 illustrates an inflow control assembly configured in accordance with an embodiment of the present technology. [Figure 6B] 1 illustrates an inflow control assembly configured in accordance with an embodiment of the present technology. [Figure 7A] 1 shows a variable flow shunt configured in accordance with one embodiment of the present technology. [Figure 7B] 1 shows a variable flow shunt configured in accordance with one embodiment of the present technology. [Figure 7C] 1 shows a variable flow shunt configured in accordance with one embodiment of the present technology. [Figure 7D] 1 shows a variable flow shunt configured in accordance with one embodiment of the present technology. [Figure 7E] 1 shows a variable flow shunt configured in accordance with one embodiment of the present technology. [Figure 8A]10 illustrates an additional embodiment of a variable flow glaucoma shunt device constructed in accordance with the present technology. [Figure 8B] 10 illustrates an additional embodiment of a variable flow glaucoma shunt device constructed in accordance with the present technology. [Figure 9A] 10 illustrates an additional embodiment of a variable flow glaucoma shunt device constructed in accordance with the present technology. [Figure 9B] 10 illustrates an additional embodiment of a variable flow glaucoma shunt device constructed in accordance with the present technology. [Figure 10] 1 shows a variable flow shunt device including an actuatable member at the outflow end of the device in accordance with an embodiment of the present technology. [Figure 11A] 1 shows a ribbon or wire constructed from a shape memory material and configured in accordance with an embodiment of the present technology. [Figure 11B] 1 shows a ribbon or wire constructed from a shape memory material and configured in accordance with an embodiment of the present technology. [Figure 11C] 1 shows a ribbon or wire constructed from a shape memory material and configured in accordance with an embodiment of the present technology. [Figure 12A] 1 illustrates a fluid control element including a variable fluid resistor constructed from a shape memory material, in accordance with an embodiment of the present technology; [Figure 12B] 1 illustrates a fluid control element including a variable fluid resistor constructed from a shape memory material, in accordance with an embodiment of the present technology; [Figure 13A] 1 is a partial cross-sectional schematic view of a variable fluid resistor including a dual lumen elastomeric tube configured in accordance with an embodiment of the present technology; [Figure 13B] 1 is a partial cross-sectional schematic view of a variable fluid resistor including a dual lumen elastomeric tube configured in accordance with an embodiment of the present technology; [Figure 13C] 10 illustrates additional embodiments of variable fluidic resistor devices constructed in accordance with the present technology. [Figure 13D] 10 illustrates additional embodiments of variable fluidic resistor devices constructed in accordance with the present technology. [Figure 13E] 10 illustrates additional embodiments of variable fluidic resistor devices constructed in accordance with the present technology. [Figure 13F] 10 illustrates additional embodiments of variable fluidic resistor devices constructed in accordance with the present technology. [Figure 14A] 10 shows a fluid control element including a variable fluid resistor constructed from a shape memory material in accordance with an additional embodiment of the present technology; [Figure 14B] 10 shows a fluid control element including a variable fluid resistor constructed from a shape memory material in accordance with an additional embodiment of the present technology; [Figure 15A] 1 shows an adjustable flow glaucoma shunt constructed in accordance with another embodiment of the present technology. [Figure 15B] 1 shows an adjustable flow glaucoma shunt constructed in accordance with another embodiment of the present technology. [Figure 15C] 1 shows an adjustable flow glaucoma shunt constructed in accordance with another embodiment of the present technology. [Figure 16A] 10 shows an adjustable flow glaucoma shunt constructed in accordance with yet another embodiment of the present technology. [Figure 16B] 10 shows an adjustable flow glaucoma shunt constructed in accordance with yet another embodiment of the present technology. [Figure 16C] 10 shows an adjustable flow glaucoma shunt constructed in accordance with yet another embodiment of the present technology. [Figure 16D] 10 shows an adjustable flow glaucoma shunt constructed in accordance with yet another embodiment of the present technology. [Figure 16E] 10 shows an adjustable flow glaucoma shunt constructed in accordance with yet another embodiment of the present technology. DETAILED DESCRIPTION OF THE INVENTION

[0013] In one embodiment, for example, an adjustable flow shunt for treating glaucoma in a human patient includes an elongated outflow drainage tube having a proximal inflow region and a distal outflow region. The proximal inflow region can include one or more apertures defining a fluid inlet area disposed to allow fluid to flow therethrough to the outflow drainage tube. The adjustable flow shunt further includes an inflow control assembly in the proximal inflow region. The inflow control assembly can include a control element sized and shaped to slidably engage the proximal inflow region and a spring element operably coupled between the control element and an anchor element engaging the proximal inflow region. The spring element is configured to be activated by non-invasive energy, and upon activation, slidably moves the control element along the proximal inflow region such that (a) the one or more apertures are accessible and have a first fluid flow cross-section, or (b) the one or more apertures are at least partially covered by the control element and have a second fluid flow cross-section smaller than the first fluid flow cross-section.

[0014] In another embodiment of the present technology, an adjustable flow shunt for treating glaucoma may comprise an elongated outflow tube having (a) a proximal inflow portion configured for placement within the anterior chamber in a region outside the visual field of a patient's eye and (b) a distal outflow portion at a different location on the eye. The adjustable flow shunt also includes an actuator disposed along the outflow tube between the inflow and outflow portions. The actuator is deformable between an open position that allows fluid to flow through the outflow tube and a resistive position that partially obstructs fluid flow through the outflow tube. During operation, the actuator is movable between positions in response to noninvasive energy.

[0015] An adjustable flow shunt assembly configured in accordance with yet another embodiment of the present technology may include an elongated drainage tube having a proximal portion and a distal portion. The proximal portion includes an inflow port configured to fluidly communicate with a fluid chamber of a patient's eye. The adjustable flow shunt may also include a variable resistor assembly configured to selectively control fluid flow to the inflow port. The variable resistor assembly of this embodiment includes a base portion and an aperture plate supported by the base portion. The aperture plate includes a plurality of first apertures therethrough. The variable resistor assembly also includes a standoff plate supported by the aperture plate and extending away from the aperture plate. The standoff plate includes a plurality of second apertures therethrough, the second apertures aligned with corresponding first apertures in the aperture plate. The variable resistor assembly further includes a membrane disposed on and supported by the standoff plate. The membrane is positioned to sealably cover an open end of each second aperture. During operation of the shunt assembly, a portion of the membrane over one or more second openings in the standoff plate is configured to be selectively targeted and removed via non-invasive energy, thereby creating a fluid pathway from the patient's bodily fluid site through the accessible open end of the targeted second opening, the corresponding first opening, and into the drainage tube.

[0016] Specific details of various embodiments of the present technology are described below with reference to Figures 3A-16E. While many of the embodiments are described below with respect to adjustable flow glaucoma shunts and related methods, other embodiments are within the scope of the present technology. Additionally, other embodiments of the present technology can have different configurations, components, and / or procedures than those described herein. For example, shunts configured in accordance with the present technology may include additional elements and features beyond those described herein, or other embodiments may not include some of the elements and features shown and described herein.

[0017] For ease of reference, the same reference numbers are used throughout this disclosure to identify like or similar components or features, but the use of the same reference numbers does not imply that the parts are to be construed as identical. Indeed, in many examples described herein, like-numbered parts differ in structure and / or function.

[0018] Selected Embodiments of Variable Flow Glaucoma Shunts 3A-16E illustrate several different embodiments of variable flow glaucoma shunt devices, along with specific components and mechanisms associated with such devices. FIG. 3A, for example, illustrates a variable flow glaucoma shunt 300 (“shunt 300”) configured in accordance with embodiments of the present technology. The shunt 300 includes an inflow control assembly 338 and an outflow drainage tube or outflow assembly 327. The inflow control assembly 338 of the shunt 300 is configured to be positioned within the anterior chamber, a region outside the eye's optical field, but within the region visible through the cornea (as described below with reference to FIG. 3C). The outflow drainage tube 327 includes a tube (e.g., a thin-walled tube with a fine bore length) sized and shaped to span the region between the anterior chamber and the desired outflow location. As described in more detail below, the inflow control assembly 338 includes a control mechanism configured to function as a variable resistor during operation.

[0019] FIG. 3B is a partially exploded view of the shunt 300 with a portion of the inflow control assembly 338 removed from the outflow drainage conduit 327 for illustrative purposes. As best seen in FIG. 3B, the proximal end 360 of the outflow drainage conduit 327 includes a proximal inflow region defined by a core element or core mechanism 342 extending therefrom. The core element 342 may be constructed of a relatively rigid material or combination of rigid materials, including, but not limited to, polyetheretherketone (PEEK), acrylic, polycarbonate, metal, ceramic, quartz, and / or sapphire. The portion of the outflow drainage conduit 327 not included in the core element 342 may be constructed of a relatively flexible material (e.g., silicone, urethane, or other suitable material). The core element 342 includes one or more openings 341 (only one is shown in the illustrated embodiment) that define a fluid inlet area 362. The fluid inlet area 362 is in fluid communication with the lumen of the outflow drainage tube 327. In other embodiments, the opening(s) 341 may have a different arrangement and / or there may be a different number of openings 341. For example, in another embodiment, the openings 341 may extend spirally around the core element 342. The opening(s) 341 are positioned to allow fluid to flow therethrough during operation of the shunt 300.

[0020] 3A and 3B together, for example, the inflow control assembly 338 of the illustrated embodiment includes a control element 339 configured to be disposed on or around the outer surface of the core element 342 (as indicated by the arrow in FIG. 3B). During operation, the control element 339 can be adjusted to cover a majority of the fluid inlet area 362. For example, in some embodiments, the control element 339 can be adjusted to increase or decrease the length of the fluid path between the edge of the control section 339 and the opening 341 ( FIG. 3B ). In some embodiments, a hydrogel coating can be applied to the inner surface of the control element 339 to further enhance the sliding ability of the control element 339 against the core element 342 and improve sealing of the components during operation. In additional embodiments, a hydrogel coating may be applied to the core element 342 (in addition to or instead of applying a coating on the control element 339). Further details regarding the adjustment / operation of the control element 339 are described below.

[0021] The inflow control assembly 338 of the illustrated embodiment may also include adjustable spring elements (shown as first and second spring elements 340 and 340′) disposed on either side of the control element 339. Each spring element 340 and 340′ may further include a corresponding anchor element 310.

[0022] In the embodiment shown in Figures 3A and 3B, the control element 339 is constructed from a single material. For example, the control element 339 may be fabricated from a material such as, but not limited to, ceramic, alumina oxide, silica oxide, sapphire, and / or quartz. Such materials may be polished to very high tolerances / precise dimensions, for example. However, in other embodiments, the control element 339 may have different portions / regions constructed from different materials. The first and second spring elements 340 and 340' may be constructed from a shape memory material (e.g., nitinol or another suitable shape memory material) that can be activated via non-invasive energy such as light (and / or heat). The anchor element 310 may be fabricated from a similar material or other suitable materials.

[0023] In operation, first and second spring elements 340 and 340′ are configured to be selectively activated by non-invasive energy and, upon activation, slidably move control element 339 in a first direction or a second direction, respectively, along the proximal inflow region so that (a) opening(s) 341 have a first fluid flow cross-section (e.g., fully open and accessible), or (b) opening(s) are at least partially covered by control element 339 and have a second fluid flow cross-section (e.g., partially open / accessible) that is smaller than the first fluid flow cross-section. Further, in some cases, control element 339 may be slidably adjusted so that opening(s) 341 are fully covered and inaccessible. One feature of the arrangement shown in FIGS. 3A and 3B is that inflow control assembly 338 can be selectively adjusted (e.g., via non-invasive energy) after placement in the eye to incrementally adjust control element 339 relative to opening 441 to provide a variety of different levels of outflow resistance.

[0024] FIG. 3C is a partial schematic diagram of the ocular capsule of a human patient, showing the adjustable flow glaucoma shunt 300 of FIGS. 3A and 3B implanted therein. In particular, a typical procedure for implanting the shunt 100 into the ocular capsule involves: (a) peeling back a portion of the conjunctiva; (b) removing a portion of the sclera to create a pocket for the plate to be placed in; (c) delivering the inflow control assembly 338 to the anterior chamber of the ocular capsule; (d) extending the outflow drainage tube 327 through tissue into the desired pocket; and (e) covering the outflow drainage tube 327 and any other portion of the shunt 300 not buried in other tissue with the conjunctiva. In the embodiment shown in FIG. 3C , for example, the shunt 300 is configured for placement across a region within the anterior chamber to a region at the suprachoroidal position of the eye. However, in other embodiments, the shunt 300 may be adapted for placement within a different portion of the eye. In one embodiment, for example, a shunt configured in accordance with the present technology may be placed in the subconjunctival region of the eye.

[0025] 3D and 3E illustrate core elements configured in accordance with different embodiments of the present technology. Referring initially to FIG. 3D, for example, core element 342 includes a plurality of openings or apertures 341′ extending therethrough that define, at least in part, a fluid pathway in communication with the lumen of a corresponding outflow drainage tube 327. The openings 341′ in the illustrated embodiment have a different arrangement / configuration than the openings 341 described above with reference to FIGS. 3A and 3B. While six openings 341′ are shown in FIG. 3D, it will be understood that in other embodiments, core element 342 can include a different number of openings 341′. Furthermore, openings 341′ may have a different arrangement relative to one another. FIG. 3E illustrates yet another embodiment of core element 342 having openings 341″ configured in accordance with yet another arrangement of the present technology. In this embodiment, openings 341″ include a plurality of elongated slots disposed about core element 342. In other embodiments, openings 341′ / 341″ may have a variety of other suitable shapes / sizes.

[0026] 4A-4C show a variable flow glaucoma shunt 400 ("shunt 400") configured in accordance with yet another embodiment of the present technology. The shunt 400 includes an inflow control assembly 438 and an outflow drainage tube or outflow assembly 427. The inflow control assembly 438 includes several features similar to the inflow control assembly 338 of the shunt 300 described above with reference to FIGS. 3A and 3B. For example, the inflow control assembly 438 includes a first or proximal spring element 440' and a second or distal spring element 440 disposed adjacent to one another. The inflow control assembly 438 further includes a core element or feature 442 coupled to an inner portion of the inflow control assembly at an anchor point 442' between the spring elements 440 and 440' (as best seen in FIGS. 4B and 4C). A fixation spine 451 extends between and is operably coupled to the spring elements 440 and 440'. Although only one fixation spine 451 is shown in the illustrated embodiment, in other embodiments, the shunt 400 can include one or more additional fixation spines. In the illustrated embodiment, the fixation spine 451 and the first and second spring elements 440 and 440' are all integrally formed from the same tube using a laser cutting process. However, in other embodiments, the spring elements 440 and 440' and / or the fixation spine 451 can be separate, individual components formed from different materials.

[0027] 3A-3C. In particular, first and second spring elements 440 and 440′ are configured to be selectively activated by non-invasive energy and, when activated, slidably move core element 442 to alter the length of the flow path through opening or slit 460 in inflow control assembly 438. With reference to FIG. 4B, for example, when distal spring 440 is expanded / activated, core element 442 moves proximally and the length of core portion 442 inside the uncut portion of shunt 400 (and the corresponding flow F through opening 460 and along flow path FP within inflow control assembly 438) is minimized.

[0028] However, referring to FIG. 4C , when the distal spring 440 is compressed and the proximal spring 440′ is expanded / actuated, the length of the inner core portion 442 of the non-cutting portion (and the corresponding flow F along the flow path FP) is maximized. The disclosed arrangement is expected to provide an effective and predictable method of incrementally increasing / decreasing flow resistance through the shunt 400 in a linear manner. In other embodiments, rather than the incremental adjustment of flow rate provided by the shunt 400 shown in FIGS. 4A-4C , the shunt 400 may be configured to provide a binary on / off arrangement via selective actuation of the first and second spring elements 440 and 440′. Furthermore, in some embodiments, the width and / or shape of the opening / slit 460 may be modified to allow further control of the flow resistance of the shunt 400. In yet another embodiment, the core pin may be fixed to the proximal end of the spring element 440′ so that it does not extend into the flow path. In such embodiments, the flow path is altered by expanding or compressing the space between the elements of springs 440 and 440'. In other embodiments, the shape of the pin and / or lumen can be modified to allow non-linear control of flow as a function of core movement.

[0029] 5A-6B illustrate an inflow control assembly configured in accordance with further embodiments of the present technology. Referring initially to FIGS. 5A and 5B, for example, inflow control assembly 538 is disposed on or around the exterior of core element 542 at the inflow or inlet region of drainage conduit 527. Inflow control assembly 538 includes control element 539 and spring element 540 secured thereto and extending proximally toward drainage conduit 527. Inflow control assembly 538 further includes anchor element 510 operably coupled to spring element 540 at the proximal region of inflow control assembly 538. FIG. 5A illustrates inflow control assembly 538 in a low or minimum flow configuration, with control element 539 positioned entirely or nearly entirely over opening 541 (FIG. 5B) in core element 542. FIG. 5B illustrates inflow control assembly 538 in a maximum flow configuration, with spring element 540 activated. In some embodiments, for example, spring element 540 is heated via non-invasive energy (e.g., laser energy), causing spring element 540 to bend outward and slidably move control element 539 proximally, exposing opening 541 and allowing fluid to flow therethrough into drainage tube 527.

[0030] 6A and 6B illustrate another embodiment of an inflow control assembly 638 constructed in accordance with the present technology. In this embodiment, the inflow control assembly 638 includes a control element 639 and first and second spring elements 640 and 640′ secured thereto and extending proximally toward the drainage conduit 627. The first and second spring elements 640 and 640′ have a different configuration than the spring elements 540 and 540′ described above with reference to FIGS. 5A and 5B. Furthermore, each spring element 640 and 640′ is operably coupled to a corresponding anchor element 610 and 610′. Because each individual spring element 640 and 640′ has its own anchor element 610 and 610′, the spring elements 640 and 640′ can be independently set to an initial configuration and independently controlled during operation. As shown in FIG. 6B , for example, individual spring elements 640 and 640′ can be actuated (e.g., via heat) to cause spring elements 640 and 640′ to coil more tightly and slidably move control element 639 proximally along core element 642 to create an open fluid pathway (to the lumen of drainage tube 627) through exposed opening 641.

[0031] 3A-6B, the inflow ends of the various shunts shown are sealed. Such shunts may be delivered via a needle (not shown) that traverses the desired flow path (as described above with reference to FIG. 3C). However, in other embodiments, the inflow ends of the shunts may be first open (to allow the shunt to be delivered over a guidewire) and then sealed after delivery and deployment.

[0032] Additional Embodiments of the Adjustable Flow Glaucoma Shunt A collection of additional embodiments of adjustable flow and / or adjustable pressure-regulating glaucoma shunts including plates are described below with reference to Figures 7A-16E. Such shunts can be implanted as described above and shown in Figure 3C, or the shunts can be implanted at other suitable locations within the eye using other suitable techniques. In some of these embodiments, the traditional outflow port is augmented with additional tubing to distribute aqueous humor over a larger area of ​​tissue. The outflow tubing is covered by at least the conjunctiva. Many of the embodiments of the present technology further comprise an adjustable fluid resistor, and some may further comprise an adjustable opening pressure control mechanism. These mechanisms can be adjusted to increase or decrease the outflow resistance and / or opening pressure of the shunt in response to changes in the following: IOP, aqueous humor production rate, natural aqueous humor outflow resistance, natural aqueous humor outflow rate, and combinations thereof.

[0033] 7A-7E illustrate another embodiment of a variable flow shunt 700 configured in accordance with the present technology. For example, FIG. 7A is a schematic top view of a shunt 700 configured for minimally invasive placement (such as the shunts described above with reference to FIGS. 3A-6B). The shunt 700 includes an elongated drainage tube 702 having a proximal portion with an inflow port 701 and a distal portion opposite the proximal portion. The shunt 700 differs from the shunts described above in that the fluid resistance of the shunt 700 is selectively controlled by modifying the number of openings that allow fluid to flow through the inflow port 701. In some embodiments, for example, the shunt 700 may be configured to allow only a continuous decrease in outflow resistance. However, in other embodiments, the shunt 700 may be configured to selectively allow both a finite decrease and an increase in outflow resistance. Further details regarding the shunt 700 and its operation are described below.

[0034] Figure 7B is a partial, enlarged cross-sectional view of shunt 700 taken along line BB in Figure 7A, and Figure 7C is an enlarged view of area C identified in Figure 7B. Referring to Figures 7B and 7C together, inflow port 701 of shunt 700 further comprises a variable resistor assembly 720 configured to selectively control the rate of fluid flow to the inflow port (and outflow port 702). Variable resistor assembly 720 includes a membrane 745 disposed on and supported on a standoff plate 746. Standoff plate 746 is operably coupled to and extends from an aperture plate 747. Aperture plate 747 is supported by a base portion or housing 748 of shunt 700.

[0035] The aperture plate 747 includes a plurality of first openings or first apertures 760 extending therethrough. The first openings 760 have a first cross-sectional dimension D1 (not shown). The first openings 760 can be precisely formed so that each opening is identical or nearly identical and all of the first openings 760 are a predetermined size. The standoff plate 746 includes a plurality of second openings or second apertures 741 extending therethrough. The second openings 741 have a second cross-sectional dimension D2 that is larger than the first cross-sectional dimension D1. As described in more detail below, the second openings 741 do not need to be formed as precisely as the first openings 760. As shown in FIG. 7C , the membrane 745 completely covers one end (top or first end) of each second opening 741. The opposite end (second or bottom end) of each second opening 741 is aligned with a corresponding first opening or first aperture 760 extending through the aperture plate 747.

[0036] FIG. 7D is a top view of the variable resistor assembly 720. As best seen in FIG. 7D, the variable resistor assembly 720 further includes a plurality of target indicia or markers 713 (“targets 713”). Each target 713 corresponds to and aligns with a respective first opening 741 (FIG. 7B). Referring now to FIG. 7E, after the shunt 700 is implanted within a patient, if it is desired to reduce the fluid resistance of the shunt 700, non-invasive energy (e.g., a surgical laser) can be directed at selected targets 713 on the membrane 745. For example, in embodiments using laser energy, the laser can be activated or fired to selectively ablate targeted material of the membrane 745, thereby removing such membrane material and exposing the open end of the corresponding second opening 741. Without the membrane blocking the targeted second opening 741, fluid can flow therethrough (as indicated by arrow F) and subsequently through the corresponding first opening 760 into the outflow drainage tube 702. If further reduction in fluid resistance is desired, one or more additional targets 713 on the membrane 745 can be removed to expose additional second openings 741 through which additional fluid can flow to the outflow drainage tube 702.

[0037] In the illustrated embodiment, there is no means for sealing the second openings 741 of the implanted shunt 700 once the corresponding targeted portion of the membrane 745 is removed, opening the second openings 741 to aqueous humor flow, thereby only lowering the outflow resistance. However, in other embodiments, there may be techniques for subsequently impeding or stopping fluid flow by sealing off one or more open second openings 741. For example, with reference to FIGS. 7B and 7C , in some embodiments, the membrane 745 and standoff plate 746 may be constructed, at least in part, from a hydrophobic material (e.g., a low-melting-point wax) adapted to be melted by a surgical laser (not shown) at a temperature that does not cause particular harm to the aqueous humor. In such embodiments, a relatively small, narrow beam from a laser source may be used to melt the wax material of the targeted membrane 754 and open the corresponding second openings 741. At a later point in time, if it is desired to slow or restrict the flow of aqueous humor, a larger beam from the laser source is used to melt the wax material of the standoff plate 746, thereby causing the material to "puddle" or accumulate above the corresponding second opening 760 within the previously opened second opening 741, thereby closing or blocking the flow of fluid through the first opening 760.

[0038] In the embodiment shown in FIGS. 7A-7E, the components of the variable resistor assembly 720 are separate, individual components that are operably coupled to one another prior to implantation of the shunt 700. The components may be constructed of similar materials or one or more different materials. However, in other embodiments, the membrane 745 and standoff plate 746 may be fabricated as a single, integral component constructed from the same material, such as in the example above, where the membrane 745 and standoff plate 746 comprise an integral component constructed from a hydrophobic material. However, in other embodiments, the integrated membrane 745 / standoff plate 746 may be constructed from other suitable materials. In still other embodiments, the standoff plate 746 and aperture plate 747 may be fabricated as a single, integral component constructed from the same material with the first and second apertures 741 and 760 formed therein. In yet additional embodiments, the aperture plate 747 may be integrally formed with the base portion 748 of the shunt 700.

[0039] 8A-9B show additional embodiments of a variable flow glaucoma shunt device constructed in accordance with the present technology. In these embodiments, the shunt is configured to be delivered to a target location within a patient's ocular capsule over a guidewire and then transforms between a delivery configuration and a deployed configuration upon removal of the guidewire. For example, FIG. 8A shows a shunt 800 in a delivery configuration over a guidewire W. The shunt 800 includes an inflow control assembly 838 and an outflow conduit or assembly 827. The inflow control assembly 838 may include several features generally similar to those of the shunt described above with reference to FIGS. 3A-6B. For example, the shunt 800 includes a control element 839 disposed over one or more openings or apertures 841 (shown in dashed lines) extending through a body portion 848 of the inflow control assembly 838. The opening(s) 841 are configured to, when at least partially exposed, allow aqueous humor to flow therethrough to the outflow conduit 827. The shunt 800 also includes a pair of adjustable spring elements 840 and 840′ disposed on either side of the control element 839. Spring elements 840 and 840′ are coupled between body portion 848 and control element 839. In some embodiments, spring elements 840 and 840′ are composed of a shape-memory material (e.g., nitinol) and are adapted to expand / contract when heat is applied. For example, applying heat to first spring element 840 can induce the spring element to coil more tightly, thereby moving control element 839 toward first spring element 840 and stretching or expanding second spring element 840′. Moving control element 839 at least partially exposes opening(s) 841, allowing aqueous humor to flow therethrough, similar to the techniques described above with reference to FIGS. 3A-6B.

[0040] In the illustrated embodiment, the inflow control assembly 838 is constructed of a first material having a first stiffness, and the outflow conduit 827 is constructed of a second material having a second stiffness that is less than the first stiffness. Referring together to Figures 8A and 8B, the shunt 800 may be pre-shaped prior to implantation so that the shunt 800 includes one or more bends along its length. In the illustrated embodiment, for example, the shunt 800 comprises a generally "L"-shaped arrangement and includes a bend or elbow 854 at or near the distal region of the outflow conduit 827.

[0041] When the shunt 800 is placed over the guidewire W for delivery, the shunt 800 assumes a generally linear, straight delivery configuration. However, as shown in FIG. 8B , when the guidewire W is removed, the shunt 800 transforms between its delivery configuration and an expanded / deployed configuration in which the shunt 800 assumes its predetermined "L"-shaped arrangement, including the elbow 865. This configuration is expected to enable rapid and reliable delivery of the shunt 800 over the guidewire W and to enable precise placement of the inflow control assembly 838 within the patient's eye once the guidewire is removed and the shunt 800 assumes its predetermined shape.

[0042] 9A and 9B show a shunt 900 configured in accordance with yet another embodiment of the present technology. The shunt 900 includes many features generally similar to those of the shunt 800. The shunt 900 differs from the shunt 800 in that the shunt 900 is not constructed of different materials having different stiffnesses. Rather, the shunt 900 includes an inflow portion or region 938 and an outflow portion or tubing 927 constructed of a single material (e.g., a shape-memory material such as Nitinol). The shunt 900, like the shunt 800 described above, includes a preset, generally "L"-shaped arrangement and includes a bend or elbow 954. However, in this embodiment, removal of the guidewire W does not cause the shunt 900 to transform between its delivery configuration (FIG. 9A) and its deployed / expanded configuration (FIG. 9B). Alternatively, as best seen in FIG. 9B, once the guidewire W is removed and the shunt 900 is in the desired location within the patient, a laser source (e.g., an ophthalmic laser, not shown) can be used to direct a laser beam to selectively heat portions of the shunt 900, causing the shunt 900 to bend around the elbow 954 and return to its preset shape (generally an "L" shaped arrangement).

[0043] FIG. 10 shows a variable flow shunt device 1000 configured in accordance with yet another embodiment of the present technology. The shunt 1000 comprises an inflow assembly 1001 and an outflow drainage tube 1027 with an outflow port 1002. The shunt 1000 further includes an actuatable member 1049 at the outflow end of the outflow port 1002 (opposite the inflow assembly 1001). The actuatable member 1049 comprises one or more tissue disruption members 1050 (e.g., barbs or other suitable types of devices) for disrupting / disrupting tissue at or near the outflow end of the outflow port 1001 after the shunt 1000 is implanted within a patient. In one embodiment, the barbs 1050 of the actuatable member 1049 can be moved and actuated by an operator via an externally applied magnetic field to disrupt targeted tissue adjacent the outflow end of the shunt 1000. However, in other embodiments, the barbs 1050 may be moved / actuated using other suitable techniques, such as a heat-induced shape change. Additionally, it will be appreciated that a different number of barbs 1050 may be used and / or the barbs 1050 may have a different arrangement relative to each other and the actuatable member 1049.

[0044] Many of the embodiments disclosed herein utilize shape memory materials (SMMs), such as nitinol or shape memory polymers, as a means of controlling an adjustable fluidic resistor. As previously described, such fluidic resistors allow for the controlled flow of aqueous humor from within the anterior chamber of the eye to locations where it diffuses. One such location is within or on the sclera behind the cornea. Generally, the SMM elements utilized in the various devices disclosed herein can be repeatedly activated in one direction to increase fluidic resistance and in another direction to decrease fluidic resistance. In some embodiments, for example, multiple activations on targets within one section of the actuation element each incrementally increase resistance, while multiple activations on targets within another section of the actuation element incrementally decrease resistance. When the target is heated above its transition temperature, such as by heating with non-invasive laser energy, the SMM transitions from a larger volume, lower stiffness, lower temperature martensitic (Mar) form to a higher temperature, smaller volume, stiffer austenitic (Aus) form. Austenite 75-83GPa, smaller volume, high temperature Mar (martensite) 28-40GPa, larger volume, low temperature

[0045] One such configuration is shown in FIGS. 11A-11C, which depict side views of a ribbon or wire configured in accordance with an embodiment of the present technology. Referring first to FIG. 11A, the ribbon is shaped and set into a shape containing multiple uniform folds. As shown, there are six folds, but it will be understood that in other embodiments, ribbons with more or fewer folds can be used depending on the amount of resolution and displacement desired. Referring now to FIG. 11B, the ribbon can then be mounted between two anchors such that the constrained length is greater than the heat-set length. Referring now to FIG. 11C, applying heat to the fold(s) in a portion of the SMM heated above its Aus shifts it from its less rigid, more voluminous Mar form to a stiffer, less voluminous Aus form. In the illustrated embodiment, even if the entire portion of the SMM is heated above its transformation temperature, the entire SMM component cannot return to its heat-set shape. The unheated portion can further expand to compensate. Furthermore, heating a previously unheated portion is expected to reverse the mechanism, stretching both the previously unheated and heated portions.

[0046] 12A and 12B show a fluid control element 1201 configured in accordance with another embodiment of the present disclosure. The fluid control element 1201 may be used with any of the variable flow shunts described herein or other suitable shunts. In this embodiment, the fluid control element 1201 comprises a variable fluidic resistor actuated by an SMM element (such as those described above with reference to FIGS. 11A-11C). Referring initially to FIG. 12A, the fluid control element 1201 comprises a base 1211 and a flow-through drainage tube 1212 carried by and operably coupled to the base 1211. For example, the flow-through tube 1212 may be secured to the base 1211 via a flow-through anchor 1209. However, in other embodiments, other suitable techniques may be used to secure the flow-through tube 1212 to the base 1211. The flow-through tube 1212 is also operably engaged with an actuator 1218. In the illustrated embodiment, the actuator 1218 is constructed of SMM and comprises a ribbon or wire including multiple folds. The actuator 1218 has a fixed length, and each end of the actuator 1218 is fixed to the base 1211 .

[0047] The actuator 1218 can be actuated using techniques similar to those described above with reference to FIGS. 11A-11C. During actuation, for example, the tops of the folds along the actuator 518 can be used as targeted regions to be selectively heated via non-invasive energy (e.g., laser energy) to locally heat such regions along the actuator 518. As described above with respect to FIGS. 11A-11C, heating the folds on one side relative to the other side allows for an incremental shift in resistance (up or down) to alter the state of the actuator 1218, thereby changing the fluid resistance through the flow-through tube 1212. For example, FIG. 12A shows a low-resistance state of the fluid control element 1201 in which the actuator 1218 is fairly uniform along its length and provides minimal resistance or interference to fluid flow through the flow-through tube 1212. FIG. 12B shows a high-resistance state of the fluid control element 1201. The high-resistance state or position can be the result of, for example, multiple actuations of the flow-through tube 1212 via the actuation element 1218. In particular, heating each fold of the actuating element 1218 on the left side of the flow-through tube 1212 above its actuation temperature causes the actuating element 1218 in this region to contract, thereby "pinching" and compressing the flow-through tube 1212 in this direction and increasing the resistance to flow therethrough. If desired, the fluid control element 1201 can be converted again to additional resistance positions or directions than those shown in FIG. 12B (e.g., back to or a different state than that shown in FIG. 12A) by further manipulation / modification of the actuating element 1218 (e.g., heating selected areas, etc.).

[0048] 13A and 13B are partial schematic cross-sectional views of a variable fluid resistor including a dual-lumen elastomeric tube 1312 configured in accordance with yet another embodiment of the present technology. More specifically, FIG. 13A shows the elastomeric tube 1312 in an initial or low-resistance state before modification. The elastomeric tube 1312 includes a first lumen or fluid flow-through lumen 1316 having an initial cross-sectional shape (e.g., a "D"-shaped lumen). The elastomeric tube 1312 further includes a second lumen or control lumen 1336 adjacent to the first lumen 1316 and a diaphragm therebetween. The control lumen 1336 includes one or more actuating elements 1318. In the illustrated embodiment, for example, the actuating element 1318 is constructed of an SMM and includes a first or expanding portion 1314 and a second or contracting portion 1315. Although only a single actuating element 1318 is shown in the cross-sectional views of Figures 13A and 13B, it will be appreciated that in further embodiments, multiple actuating elements 618 may be arranged continuously along the length of the elastomeric tube 1312.

[0049] FIG. 13B shows elastomeric tube 1312 in an increased or higher resistance state after activation of actuating element 1318. More specifically, non-invasive energy (e.g., heating by laser energy) is applied to expansion portion 1314 of actuating element 1318, thereby expanding actuating element 1318. Such expansion pushes the septum toward flow-through lumen 1316, reducing the cross-sectional dimension of flow-through lumen 1316. This reduction in the size of flow-through lumen 1316 therefore increases the fluid resistance through lumen 1316. The cross-sectional dimension of flow-through lumen 1316 can be further modified through additional modifications of actuating element 1318. For example, the fluid resistance through flow-through lumen 1316 can be further reduced by additional heating of expansion portion 1314 or returned to a lower resistance state through heating of contraction portion 1315.

[0050] FIG. 13C illustrates another embodiment of an inflow-mounted variable resistor 1320 in accordance with the present technology. In this embodiment, multiple actuation elements 618 can be arranged consecutively along the length of the control lumen 636 (FIG. 13A). Actuation of the expansion portion 1314 of each target actuation element 1318 increases the length of the restriction zone, thereby linearly increasing fluid resistance. Similarly, actuation of the contraction portion(s) 1315 of the target actuation element(s) 1318 can decrease fluid resistance. As shown in FIG. 13C, such fluid control can be incorporated into the shunt plate 1303, inflow tubing 1305, outflow-mounted variable resistor 1321, and / or outflow tubing (not shown).

[0051] FIG. 13D illustrates a variable fluid resistor configured in accordance with yet another embodiment of the present technology. The embodiment illustrated in FIG. 13D may include many features similar to those of the variable fluid resistors described above with reference to FIGS. 13A and 13B. However, in this embodiment, an elastomeric tube 1312 includes a single fluid flow-through lumen 1316, and an actuation assembly 1322 disposed along the elastomeric tube 1312 includes a dual lumen arrangement similar to that described above. In particular, the actuation assembly 1322 includes a first lumen 1316′ having a predetermined cross-sectional shape (e.g., a “D”-shaped lumen). The elastomeric tube 1312 is disposed within and extends through the first lumen 1316′ of the actuation assembly 1322. The actuation assembly 1322 further includes a second lumen, or control lumen 1336′, adjacent to the first lumen 1316′. The control lumen 1336′ includes one or more actuation elements 1318 similar to those previously described. In this embodiment, for example, actuation element 1318 is constructed of SMM and includes a first or expanding portion 1314 and a second or contracting portion 1315 .

[0052] Selective heating of the expansion portion 1314 can expand the actuation element 1318. Similar to the arrangement described above with reference to FIGS. 13A and 13B , such expansion reduces the cross-sectional dimension of the elastomeric tube 1312 by driving the elastomeric tube 1312 away from the control lumen 1336′ and toward the fixed inner wall of the first lumen 1316′. By reducing the cross-sectional dimension of the elastomeric tube 1312, the resistance to flow through the tube 1312 correspondingly increases. The resistance to flow through the elastomeric tube 1312 can be further reduced by additional heating of the expansion portion 1314, or the elastomeric tube 1312 can be returned to a lower resistance state via heating of the contracted portion 1315 of the actuation element 1318. While only a single actuation assembly 1322 is shown, it will be understood that in further embodiments, multiple actuation assemblies 1322 can be disposed along the length of the elastomeric tube 1312.

[0053] 13E and 13F are partial schematic cross-sectional views of a fluidic resistor including a dual-lumen elastomeric tube 1312′ configured in accordance with yet another embodiment of the present technology. The fluidic resistor of the embodiment shown in FIGS. 13E and 13F operates using principles similar to those described above with reference to FIGS. 13A and 13B. For example, FIG. 13E shows the elastomeric tube 1312′ in an initial or low-resistance state before modification. The elastomeric tube 1312′ includes a first lumen or fluid flow-through lumen 1316′ having an initial cross-sectional shape (e.g., a “D”-shaped lumen). The elastomeric tube 1312′ further includes a second lumen or control lumen 1336′ adjacent to the first lumen 1316. The control lumen 1336′ is filled with a control fluid. 13F , as the volume of control fluid increases, the cross-sectional dimension of the flow-through lumen 1316′ decreases as the elastomeric diaphragm 1337 expands into the flow-through lumen 1316′, thereby increasing fluid resistance and decreasing flow through the lumen 1316′. Similarly, as control fluid is removed from the control lumen 1336′, the elastomeric diaphragm 1337 contracts and the cross-sectional dimension of the flow-through channel 1316′ increases, thereby decreasing fluid resistance and increasing outflow through the lumen 1316′. Control fluid can be removed from or added to the control lumen 1336′, for example, using a syringe. In some embodiments, one or more reservoirs (not shown) may be fluidly connected to the control lumen 1336′, and the fluid volume of the control lumen 1336′ may be adjusted by adding or removing fluid from the reservoir(s). Furthermore, it will be understood that in some embodiments, a fluid control system configured in accordance with the present technology may comprise multiple fluid control sealing lumens distributed continuously along the length of the control system.

[0054] 14A and 14B illustrate yet another embodiment of an SMM-based actuator 1418 constructed in accordance with the present technology and adapted for use in an adjustable-flow glaucoma shunt. In this embodiment, the actuator 1418 includes one or more coils 1424 disposed around a clamping arm 1423. Both the coil 1424 and the clamping arm 1423 may be constructed of SMM. An anchor 1410 is positioned to securely hold the actuator 1418 in place on the base 1411, thereby forcing the clamping arm 1423 against the elastomeric flow-through tube 1412. The elastomeric flow-through tube 1412 may have a stiffness that maintains the outer coil 1424 in a state comparable to the implementation of the ribbon / wire actuator 1318 described above with reference to FIGS. 12A-13B.

[0055] During operation, sections of the coil(s) 1424 can be selectively actuated to adjust the clamping pressure of the clamp arm 1423 against the flow-through tube 1412, thereby adjusting the fluid resistance. With reference to FIG. 14B , for example, the coils 1424 on one side (e.g., the right side) of the clamp arm 1423 can be heated via laser energy applied to the target site 1413. Such heating actuates selected coils 1424, causing them to wrap more tightly, thereby actuating the clamp arm 1423 and increasing the pressure and resistance on the flow-through tube 1412. Actuation of the coil 1424 on the opposite side of the clamp arm 1423 (the left coil) relaxes the clamp arm 1423, thereby decreasing the pressure and resistance on the flow-through tube 1412.

[0056] In alternative embodiments, the actuator 1418 can be set to a rest or initial position such that the clamp arm 1423 fully occludes the flow-through 1412 and the coil 1424 can be selectively adjusted to increase or decrease the tension of the clamp arm 1423 relative to the base 1411. Thus, during operation, the base 1411 functions as an anvil when the clamp arm 1423 drives the flow-through tube 1412 relative to the base 1411. In some embodiments, such an arrangement can be used to operate an adjustable opening pressure valve (not shown) that is set to selectively control a desired controlled intraocular pressure (IOP). However, in other embodiments, the actuator 1418 can have a different arrangement and / or include a different mechanism.

[0057] 15A-15C show an adjustable glaucoma shunt 1500 constructed in accordance with another embodiment of the present technology and including a fluidic resistor element as described above with reference to FIGS. 14A and 14B. For example, FIG. 15A is an exploded view of the shunt 1500, and FIG. 15B is a top view of the assembled shunt 1500. Referring together to FIGS. 15A and 15B, the shunt 1500 comprises an elastomeric flow-through tube 1512 supported by and operably coupled to a control assembly 1519. The flow-through tube 1512 comprises an inflow region or portion 1505 at one end of the flow-through tube 1512 and an outflow assembly 1527 comprising one or more outflow ports 1502 at or near the opposite end of the flow-through tube 1512.

[0058] The shunt 1500 also includes an actuator 1518 supported by and operably coupled to a control assembly 1519. The actuator 1518 can be similar to the actuator 1418 described above with reference to Figures 14A and 14B. In the illustrated embodiment, for example, the actuator 1518 includes a clamp arm 1523 operably coupled to and positioned between a plurality of coils 1524. The coils 1524 (such as the coils 1424 described above) are constructed of SMM and can be adapted to selectively adjust the flow-through tube 1512 to increase / decrease pressure therethrough, as previously described.

[0059] In the illustrated embodiment, the shunt 1500 includes a pressure port 1528 and a corresponding pressure transducer 1529 configured to be disposed within a pressure transducer housing 1530 on the control assembly 1519. The pressure port 1528 / pressure transducer 1529 is configured to provide pressure information to a clinician / operator during operation of the shunt 1500. In other embodiments, the pressure port and / or pressure transducer 1529 may have different arrangements relative to each other and other components of the shunt 1500. Furthermore, the pressure port 1528 / pressure transducer 1529 are optional components that may not be included in some embodiments. In some embodiments, the shunt 1500 may also optionally include a differential port 1526 on the control assembly 1519.

[0060] The shunt 1500 may further include a plate 1503 configured to be positioned over at least a portion of the control assembly 1518, the flow-through tube 1512, and the actuator 1518. The plate 1503 may include a window 1531 that provides access to the actuator 1518 and other components supported by the control assembly 1519 when the shunt 1500 is assembled (as shown in FIG. 15B ).

[0061] 15C shows an implant tool 1534 configured to deliver and position a shunt 1500 within a patient's eye capsule (not shown) in accordance with an embodiment of the present technology. The implant tool 1534 may include, for example, a guide needle 1532 configured to carry the shunt 1500 for delivery, and a guide needle release 1533 that an operator can actuate to release the shunt 1500 once in a desired position / orientation within the patient. However, in other embodiments, the implant tool 1534 may have a different configuration and / or the shunt 1500 may be delivered using other suitable devices / techniques.

[0062] 16A-16E illustrate various features of an adjustable glaucoma shunt 1600 configured in accordance with yet another embodiment of the present technology. The shunt 1600 may include many features similar to those of the shunt 1500 described above with reference to FIGS. 15A-15C. For example, as best seen in FIG. 16A, the shunt 1600 includes a flow-through tube 1612 having an inflow port or area 1601 at one end and an outflow port 1602 at the opposite end of the flow-through tube 1612. The shunt 1600 further includes a control assembly 1619 configured to regulate flow through the flow-through tube 1612. The flow-through tube 1612, the control assembly 1619, and many other components of the shunt are supported by a plate 1603.

[0063] However, shunt 1600 differs from shunt 1500 in that it includes a different system for regulating fluid flow along flow-through tube 1612. In particular, rather than the previously described actuator 1518 including clamp arm 1523 / coil 1524, shunt 1600 of this embodiment includes an arrangement similar to that described above with reference to FIGS. 13E and 13F. Referring to FIGS. 16B-16D, for example, control assembly 1629 of shunt 1600 includes control fluid 1644 contained within control fluid chamber 1636, which includes an annular region around the thin-walled tubular flow-through channel of tube 1612. Control fluid chamber 1636 is fluidly isolated from the flow-through channel. Reservoir 1643 is connected to and in fluid communication with the control fluid chamber. Reservoir 1643 is configured to provide a larger target for conveniently injecting or removing control fluid 1636 from the system. During operation, control fluid 1644 can be added / removed from control fluid chamber 1636 to increase / decrease the fluid cross-sectional dimension of the aqueous humor flow path 1616 through flow-through channel 1612, thereby decreasing / increasing the corresponding fluid flow rate therethrough.

[0064] In some embodiments, a solid core can optionally be introduced into the flow path 1616 to provide an even further initial reduction in the fluid cross-sectional dimension, thereby making the flow path more sensitive to small changes in the diameter of the flow-through channel 1612. In Figure 16E, for example, an optional solid core pin or element 1637 has been introduced into the flow-through channel 1612, and the flow path 1616 now has a circular cross-sectional profile.

[0065] In the illustrated embodiment, the shunt 1600 further comprises a pressure transducer 1629. The pressure transducer 1629 is an optional component that may not be included in some embodiments. Additionally, it will be understood that the shunt 1600 can include features other than those described herein and / or the features of the shunt 1600 can have different arrangements relative to one another.

[0066] In many of the embodiments described herein, the actuator or fluidic resistor is configured to compress or "pinch" the drainage tube during operation. In this manner, the actuator / fluidic resistor can incrementally or continuously vary the resistance to flow through the drainage tube to selectively adjust pressure / flow. Thus, actuators and fluidic resistors configured in accordance with the present technology can adjust the level of resistance or compression between many different positions and accommodate a multitude of variables (e.g., IOP, aqueous humor production rate, natural aqueous humor outflow resistance, and / or natural aqueous humor outflow rate) to precisely adjust the flow rate through the drainage tube.

[0067] All of the disclosed actuators and fluidic resistors can be operated using non-invasive energy. This feature allows such devices to be implanted in a patient and then modified / adjusted over time without further invasive surgery or procedures for the patient. Furthermore, because the devices disclosed herein can be actuated via non-invasive energy, such devices do not require additional power to maintain a desired orientation or position. Rather, the actuators / fluidic resistors disclosed herein can maintain a desired position / orientation without power. This can significantly extend the usable life of such devices, allowing them to remain effective long after the initial implantation procedure. [Example]

[0068] Some aspects of the present technology are described in the examples below. 1. An adjustable flow shunt for treating glaucoma in a human patient, the shunt comprising: an elongated outflow drainage tube having a proximal inflow region and a distal outflow region; an inflow control assembly in the proximal inflow region, comprising: a control element sized and shaped to slidably engage the proximal inflow region; and an inflow control assembly comprising a spring element operably coupled between the control element and an anchor element engaged to the proximal inflow region; the proximal inflow region includes one or more openings defining a fluid inlet area positioned to allow fluid to flow therethrough into the outflow drainage conduit; The adjustable flow shunt is configured to be activated by non-invasive energy, and upon activation, slidably actuates the control element along the proximal inflow region so that (a) one or more openings are accessible and have a first fluid flow cross-section, or (b) one or more openings are at least partially covered by the control element and have a second fluid flow cross-section that is smaller than the first fluid flow cross-section. 2. An adjustable flow shunt as described in Example 1, wherein the proximal inflow region comprises a core element operably connected to and extending from the proximal end of the outflow drainage tube, and wherein one or more openings extend through a side wall of the core element to define a fluid inlet area. 3. The adjustable flow shunt described in Example 2, wherein the core element is constructed of a different material than the outflow drainage tubing. 4. The adjustable flow shunt of example 2, wherein the core element is constructed from a first material having a first stiffness, and the outflow drainage tube is constructed from a second material having a second stiffness less than the first stiffness. 5. The adjustable flow shunt of example 2, wherein the core element is constructed from polyetheretherketone (PEEK), acrylic, polycarbonate, metal, ceramic, quartz, and / or sapphire. 6. The adjustable flow shunt of any one of Examples 1-5, wherein the elongated outflow drainage tube is constructed from silicone and / or urethane. 7. The adjustable flow shunt of any one of Examples 1-6, wherein the spring element is constructed from a shape memory material. 8. The adjustable flow shunt of any one of Examples 1-6, wherein the spring element is constructed from Nitinol. 9. The adjustable flow shunt of any one of Examples 1-8, wherein the inflow control assembly is configured for placement within the anterior chamber in a region outside the optical field of the eye. 10. The adjustable flow shunt of Example 9, wherein the outflow drainage tubing is sized and shaped to traverse the interchamberal region of the eye to a region in a suprachoroidal position. 11. The adjustable flow shunt of Example 9, wherein the outflow drainage tubing is sized and shaped to traverse the interchamberal region of the eye to a region in a subconjunctival position. 12. An adjustable flow shunt according to any one of Examples 1-11, wherein the one or more openings comprise a single elongated slot extending axially along the proximal inflow region. 13. The adjustable flow shunt of any one of Examples 1-11, wherein the one or more openings comprise a plurality of openings extending radially around the proximal inflow region. 14. An adjustable flow shunt according to any one of Examples 1-11, wherein the one or more openings comprise a plurality of openings extending in a spiral around the proximal inflow region. 15. The adjustable flow shunt of any one of Examples 1-14, wherein the spring element is configured for activation via laser energy. 16. The spring element comprises a first spring, the anchor comprises a first anchor, the first spring and the first anchor are disposed on a first side of the control element, and the inflow control assembly further comprises: a second spring and a corresponding second anchor on a second side opposite the control element; An adjustable flow shunt as described in any one of Examples 1 to 15, wherein the first and second spring elements are configured to be selectively activated by non-invasive energy and, upon activation, slidably move the control element in a first direction or a second direction, respectively, along the proximal inflow region so that (a) one or more openings have a first fluid flow cross-section, or (b) one or more openings are at least partially covered by the control element and have a second fluid flow cross-section that is smaller than the first fluid flow cross-section. 17. The adjustable flow shunt of example 16, wherein the first and second spring elements are configured, upon activation, to slidably move the control element along the proximal inflow region so that the one or more openings are completely covered and inaccessible. 18. The adjustable flow shunt of any one of Examples 1-15, wherein the spring element and corresponding anchor element are disposed at the proximal end of the control element between the control element and the outflow drainage tube. 19. The adjustable flow shunt of any one of examples 1-15, wherein the spring element comprises one or more coil springs extending around the proximal inflow region. 20. The adjustable flow shunt of any one of examples 1-15, wherein the spring element comprises one or more elongated arcuate springs extending between the control element and the anchor element. 21. An adjustable flow shunt assembly for the treatment of glaucoma, comprising: an elongated drainage tube having a proximal portion and a distal portion, the proximal portion including an inflow port configured to be in fluid communication with a fluid chamber of the patient's eye; A variable resistor assembly configured to selectively control fluid flow to an inlet port, comprising: The base part and an aperture plate supported by the base portion, the aperture plate having a plurality of first apertures therethrough; a standoff plate supported by and extending away from the aperture plate, the standoff plate having a plurality of second openings therethrough, the second openings aligned with corresponding first openings in the aperture plate; a variable resistor assembly comprising: a membrane disposed on and supported by the standoff plate, the membrane being positioned to sealably cover an open end of each of the second openings; During operation, a portion of the membrane over one or more second openings of the stand-off plate is configured to be selectively targeted and removed via non-invasive energy, thereby creating a fluid pathway from the patient's bodily fluid site through the accessible open end of the targeted second opening, through the corresponding first opening, and to the drainage tube, an adjustable flow shunt assembly. 22. The first opening has a first cross-sectional dimension; 22. The adjustable flow shunt assembly of example example 21, wherein the second opening has a second cross-sectional dimension that is greater than the first cross-sectional dimension. 23. The adjustable flow shunt assembly of example 21, wherein the first openings have the same cross-sectional dimension. 24. An adjustable flow shunt assembly according to any one of Examples 21-23, wherein the standoff plate is at least partially constructed from a hydrophobic material configured to be at least partially melted via non-invasive energy. 25. An adjustable flow shunt assembly according to any one of Examples 21-23, wherein the standoff plate is at least partially constructed from a wax material configured to be at least partially melted via non-invasive energy. 26. An adjustable flow shunt assembly according to any one of Examples 21-23, wherein the base portion of the variable resistor assembly, the aperture plate, and the standoff plate are separate, individual components operably coupled to one another. 27. The adjustable flow shunt assembly of any one of Examples 21-23, wherein the standoff plate and the membrane are fabricated as a single, integral component composed of the same material. 28. The adjustable flow shunt assembly of any one of Examples 21-23, wherein the aperture plate and the standoff plate are fabricated as a single, integral component composed of the same material. 29. The membrane further comprises a plurality of target indicia aligned with and corresponding to each of the second openings; An adjustable flow shunt assembly as described in any one of Examples 21 to 28, wherein during operation, non-invasive energy is delivered to corresponding target indicia on the membrane to selectively remove membrane material at the target locations. 30. An adjustable flow shunt for the treatment of glaucoma in a human patient, the adjustable flow shunt comprising: an elongated outflow tube having (a) a proximal inflow portion configured for placement within the anterior chamber in a region outside the optical field of the patient's eye, and (b) a distal outflow portion at a different location on the eye; an actuator disposed along the outflow tube between the inlet and outlet portions, the actuator being deformable between an open position that allows fluid to flow through the outflow tube and a resistive position that partially obstructs fluid flow through the outflow tube; In operation, the actuator is movable between positions in response to non-invasive energy, an adjustable flow shunt. 31. An adjustable flow shunt as described in example 30, wherein the actuator is configured to engage the outflow tube and partially obstruct fluid flow through the outflow tube at the resistance location by changing the diameter and / or cross-sectional shape of the outflow tube. 32. The adjustable flow shunt of example 30 or example 31, wherein the actuator is movable between positions in response to laser energy. 33. The outflow tube comprises a dual lumen tube having a first lumen for conveying fluid therethrough and a second lumen adjacent to the first lumen and separated by the first lumen by a septum; an actuator disposed within the second lumen and including one or more actuating elements configured to transform between an expanded state and an initial state in response to non-invasive energy; 31. The adjustable flow shunt of example 30, wherein in the expanded state, the actuation element engages the septum and pushes the septum toward the first lumen, reducing its cross-sectional dimension. 34. An adjustable flow shunt according to any one of examples 30-33, wherein the actuator is configured to hold one of an open position or a resistive position without power. 35. An adjustable flow shunt comprising: an elongate outflow tube having a proximal inflow portion configured for placement at a first location within a patient's eye and a distal outflow portion at a second location on the eye spaced from the first location; an outflow tube comprising a dual lumen tube having a first lumen for conveying fluid therethrough and a second lumen adjacent to and fluidly isolated from the first lumen; a control fluid disposed within the second lumen; During operation, Increasing the volume of control fluid in the second lumen reduces the cross-sectional dimension of the first lumen, thereby partially obstructing fluid flow through the first lumen; An adjustable flow shunt, wherein decreasing the volume of the control fluid in the second lumen increases the cross-sectional dimension of the first lumen, thereby increasing fluid flow through the first lumen. 36. The adjustable flow shunt of example 35, wherein the elongated outflow tube comprises an elastomeric tube. 37. The adjustable flow shunt of Example 35 or Example 36, further comprising a reservoir in fluid communication with the second lumen, wherein the volume of control fluid in the second lumen is altered by transferring control fluid to and / or from the reservoir. 38. An adjustable flow shunt according to any one of examples 35-37, wherein the volume of the control fluid in the second lumen is changed by transferring control fluid to and / or from the second lumen via a syringe. 39. A first lumen is separated from a second lumen by a septum; Increasing the volume of control fluid in the second lumen causes the diaphragm to move toward the first lumen, decreasing its cross-sectional dimension; An adjustable flow shunt as described in any one of Examples 35 to 38, wherein decreasing the volume of the control fluid in the second lumen causes the diaphragm to move away from the first lumen and increase its cross-sectional dimension. 40. A shunt for the treatment of glaucoma in a human patient, the shunt comprising: an elongated outflow drainage tube having a proximal inflow region and a distal outflow region; an inflow control assembly in the proximal inflow region; A shunt having a transition region along the outflow tubing between the inflow region and the outflow region, wherein during operation the transition region is deformable between a first, generally linear delivery shape and a second shape different from the first shape to secure the shunt in a desired position in the eye. 41. The shunt of example 40, wherein the outflow drainage tube is configured to be delivered over a guidewire, and wherein the transition region is configured to transform between the first delivery shape and the second shape upon removal of the guidewire. 42. The shunt of example 40 or example 41, wherein the transition region is configured to transform between the first delivery shape and the second shape upon application of non-invasive energy to one or more selected areas of the transition region. 43. The shunt of example 40 or example 41, wherein the transition region is configured to transform between the first delivery shape and the second shape in response to application of non-invasive laser energy to one or more selected areas of the transition region. 44. The shunt of any one of examples 40-43, wherein the second shape comprises a generally "L" shaped configuration.

[0069] conclusion The above detailed description of embodiments of the present technology is not intended to be exhaustive or to limit the present technology to the precise form disclosed above. Specific embodiments of the present technology, and examples thereof, have been described above for illustrative purposes; however, those skilled in the relevant art will recognize that various equivalent modifications are possible within the scope of the present technology. For example, any feature of a variable flow shunt described herein may be combined with any feature of another variable flow shunt described herein, and vice versa. Furthermore, while steps are presented in a specific order, alternative embodiments may perform steps in a different order. The various embodiments described herein may be combined to provide further embodiments.

[0070] From the foregoing, it will be understood that, although specific embodiments of the present technology have been described herein for illustrative purposes, well-known structures and functions associated with variable flow shunts have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the present technology. Where the context permits, singular or plural terms may include the plural or singular term, respectively.

[0071] Furthermore, unless the word "or" is expressly limited in reference to a list of two or more items to mean only a single item exclusively from the other items, the use of "or" in such a list shall be interpreted as including (a) a single item in the list, (b) all items in the list, or (c) any combination of items in the list. In addition, the term "comprising" is used throughout to mean the inclusion of at least the recited features, thereby not excluding additional types of the same and / or other features. It will also be understood that, while particular embodiments have been described herein for illustrative purposes, various modifications can be made without departing from the present technology. Furthermore, while advantages associated with some embodiments of the present technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments necessarily exhibit such advantages to be within the scope of the present technology. Accordingly, the present disclosure and related technology may encompass other embodiments not expressly shown or described herein.

Claims

[Claim 1] The invention described in this specification.

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