Adjustable shunt system having a control element and related systems and methods - Patents.com

Abstract

The present technology is generally directed to an adjustable shunt system for draining fluid from a first body region to a second body region. The adjustable shunt system includes an actuation assembly for controlling the flow of fluid through the system. For example, the actuation assembly can include one or more fluid inlets in fluid communication with an environment external to the system. The actuation assembly can further include one or more actuators configured to move corresponding control elements to control the fluid flow through the fluid inlets. The actuators can also have a first actuation element and a second actuation element configured to move the control elements between a first position in which the control elements substantially obstruct the fluid flow through the corresponding inlets and a second position in which the control elements do not substantially obstruct the fluid flow through the fluid inlets.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 215,633, filed June 28, 2021, the entirety of which is incorporated herein by reference.

[0002] FIELD OF THEINVENTION The present technology relates generally to implantable medical devices, and more particularly to adjustable shunt systems and associated methods for selectively controlling fluid flow between a first body region and a second body region of a patient. [Background technology]

[0003] Implantable shunt systems are widely used to treat various patient conditions by shunting fluid from a first body region / cavity to a second body region / cavity. Fluid flow through a shunt system is primarily controlled by the pressure gradient across the shunt and the physical characteristics of the flow path defined through the shunt (e.g., the resistance of the shunt lumen). However, most shunt systems have a single static flow path that is not adjustable. Thus, one challenge with conventional shunt systems is to select an appropriately sized shunt for a particular patient. A shunt that is too small may not provide sufficient therapy to the patient, and a shunt that is too large may create new problems for the patient. Despite this, most conventional shunts cannot be adjusted after implantation and therefore cannot be adjusted or titrated to meet the individual and varying needs of patients and / or to account for changes in flow-related characteristics such as flow rate, inflow pressure, and / or outflow resistance. Summary of the Invention [Means for solving the problem]

[0004] The present technology is generally directed to an adjustable shunt system for draining fluid from a first body region to a second body region. The adjustable shunt system includes an actuation assembly for controlling fluid flow through the system. For example, the actuation assembly can include one or more fluid inlets in fluid communication with an environment external to the system. The actuation assembly can further include one or more actuators configured to control fluid flow through the fluid inlets. In particular, each actuator can include a control element configured to correspond to and interface with one of the fluid inlets. For example, each control element can be vertically or axially aligned with the corresponding fluid inlet. The actuator can also have a first actuation element and a second actuation element configured to move the control element between (a) a first position in which the control element substantially prevents fluid flow through the corresponding inlet (e.g., the control element covers or blocks the inlet) and (b) a second position in which the control element does not substantially prevent fluid flow through the corresponding fluid inlet (e.g., the fluid inlet is accessible).

[0005] As described in more detail below, it is expected that in at least some embodiments, the present technology may exhibit one or more advantageous characteristics that improve the operation of the adjustable shunt system. For example, at least some of the actuation assemblies are expected to exhibit improved thermal isolation between the first and second actuation elements to reduce unintended heating of the non-actuated / non-targeted actuation elements. Additionally, at least some of the actuation assemblies are expected to exhibit improved fluid sealing performance between the control element and the fluid inlet when the control element is in the "closed" position, e.g., due at least in part to the orientation and / or movement of the control element relative to the fluid inlet. In at least some embodiments, the actuation assemblies can include one or more sealing elements, such as a gasket or elastomeric seal, positioned between the control element and the fluid inlet. These sealing elements are also expected to improve the fluid sealing performance of the actuation assembly. Furthermore, at least some of the actuation assemblies are expected to exhibit improved manufacturing characteristics, e.g., multiple actuators can be manufactured simultaneously and / or can be automatically deformed relative to a preferred and / or original geometry during the assembly process. Of course, the present technology may also provide additional advantageous properties not expressly described herein. [Brief description of the drawings]

[0006] 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, components may be shown as transparent in certain figures for clarity of illustration only, and are not intended to imply that the components shown are necessarily transparent. Components may also be shown in schematic form. [Figure 1A] 1 illustrates an adjustable shunt system constructed in accordance with selected embodiments of the present technology. [Figure 1B]1 illustrates an adjustable shunt system constructed in accordance with selected embodiments of the present technology. [Figure 1C] 1 illustrates an adjustable shunt system constructed in accordance with selected embodiments of the present technology. [Figure 1D] 1 illustrates an adjustable shunt system constructed in accordance with selected embodiments of the present technology. [Figure 2A] 1D illustrates selected aspects of the actuation assembly of FIG. 1C, with other aspects of the system omitted for clarity. [Figure 2B] 1D illustrates selected aspects of the actuation assembly of FIG. 1C, with other aspects of the system omitted for clarity. [Figure 2C] 1D illustrates selected aspects of the actuation assembly of FIG. 1C, with other aspects of the system omitted for clarity. [Figure 3A] 1 illustrates an actuation assembly configured in accordance with selected embodiments of the present technology. [Figure 3B] 1 illustrates an actuation assembly configured in accordance with selected embodiments of the present technology. [Figure 4A] 1 illustrates another actuation assembly configured in accordance with selected embodiments of the present technology; [Figure 4B] 1 illustrates another actuation assembly configured in accordance with selected embodiments of the present technology; [Figure 4C] 1 illustrates another actuation assembly configured in accordance with selected embodiments of the present technology; [Figure 4D] 1 is a block diagram of a method for manufacturing an actuation assembly in accordance with selected embodiments of the present technique. [Figure 5A] 1 illustrates another actuation assembly configured in accordance with selected embodiments of the present technology; [Figure 5B] 1 illustrates another actuation assembly configured in accordance with selected embodiments of the present technology; [Figure 5C] 1 illustrates another actuation assembly configured in accordance with selected embodiments of the present technology; [Figure 6A]5D illustrates a first actuator of the actuation assembly shown in FIG. 5C, with certain aspects of the actuation assembly omitted for clarity. [Figure 6B] 5D illustrates a first actuator of the actuation assembly shown in FIG. 5C, with certain aspects of the actuation assembly omitted for clarity. [Figure 7A] FIG. 6C illustrates a first actuator of the actuation assembly shown in FIGS. 6A and 6B, with certain aspects of the first actuator omitted for clarity. [Figure 7B] FIG. 6C illustrates a first actuator of the actuation assembly shown in FIGS. 6A and 6B, with certain aspects of the first actuator omitted for clarity. [Figure 8A] FIG. 1 is a top view of an actuation assembly configured in accordance with an embodiment of the present technology. [Figure 8B] FIG. 1 is a top view of an actuation assembly configured in accordance with an embodiment of the present technology. [Figure 9A] 13 is a top view of an actuation assembly configured in accordance with a further embodiment of the present technology; FIG. [Figure 9B] 13 is a top view of an actuation assembly configured in accordance with a further embodiment of the present technology; FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0007] The terminology used in the description presented below is intended to be interpreted in its broadest reasonable manner, even when used in conjunction with the detailed description of certain specific embodiments of the present technology. Certain terms may even be emphasized below, however, any terms intended to be interpreted in any limited manner are so clearly and specifically defined in this detailed description section. Additionally, the present technology may include other embodiments within the scope of the examples that are not described in detail with respect to Figures 1A-10.

[0008] Throughout this specification, references to "one embodiment" or "an embodiment" mean that a particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment of the technology. Thus, the appearances of the phrase "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, particular features or characteristics may be combined in any suitable manner in one or more embodiments.

[0009] Throughout this specification, references to relative terms, such as "generally," "approximately," and "about," are used herein to mean the stated value plus or minus 10%. References throughout this specification to the term "resistance" refer to fluid resistance unless the context clearly dictates otherwise. The terms "drainage rate" and "flow rate" are used interchangeably to describe the movement of a fluid through a structure at a particular volumetric flow rate. The term "flow" is used generally herein to refer to the movement of a fluid.

[0010] Although certain embodiments herein are described with respect to shunting fluid from the anterior chamber of the eye, those skilled in the art will understand that the technology can be readily adapted to shunt fluid from and / or between other parts of the eye, and more generally, from and / or between a first body region and a second body region. Additionally, although certain embodiments herein are described in the context of glaucoma treatment, any embodiment herein, including those referred to as "glaucoma shunts" or "glaucoma devices," may nevertheless be used and / or modified to treat other diseases or conditions, including other diseases or conditions of the eye or other body regions. For example, the systems described herein can be used to treat diseases characterized by increased pressure and / or accumulation of fluid, including, but not limited to, heart failure (e.g., heart failure with preserved ejection fraction, heart failure with reduced ejection fraction, etc.), pulmonary failure, renal failure, hydrocephalus, etc. Additionally, although generally described with respect to shunting water, the systems described herein may be equally applied to shunt other fluids, such as blood or cerebrospinal fluid, between a first body region and a second body region.

[0011] 1A-1D depict an intraocular shunt system ("system 100") configured in accordance with selected embodiments of the present technology. In particular, FIG. 1A is a perspective view of system 100, FIG. 1B is another perspective view of system 100, FIG. 1C is a perspective view of the area marked as "1C" in FIG. 1A, further including a view of a shape memory actuation assembly 110 ("actuation assembly 110") of system 100 with other aspects of system 100 omitted for clarity, and FIG. 1D is a perspective view of a base 122 of actuation assembly 110. As described in more detail below, system 100 is configured to provide an adjustable therapy for draining fluid from a first body region, such as draining aqueous humor from the anterior chamber of a patient's eye.

[0012] Referring initially to FIG. 1A, the system 100 includes a housing 102 and a generally elongated drainage element 104 ("drainage element 104"). The housing 102 has a first end portion 102a and a second end portion 102b and defines a chamber 106 that is configured to receive and accommodate an actuation assembly 110, as described below. The drainage element 104 can have a hollow interior or channel 105 extending between the first end portion 104a and the second end portion 104b. The chamber 106 and the channel 105 can be fluidly connected to one another to facilitate evacuation of fluid from within the chamber 106 via the channel 105. For example, in the illustrated embodiment, the second end portion 102b of the housing 102 further includes an opening or port 103 that fluidly couples the chamber 106 to the first end portion 104a and the channel 105 of the drainage element 104.

[0013] The housing 102 and the drainage element 104 may be constructed of the same or different materials. In some embodiments, the housing 102 and / or the drainage element 104 are constructed of a slightly elastic or flexible biocompatible material (such as, for example, silicone). Although the housing 102 is shown in FIGS. 1A and 1B as a right-angled prism, in other embodiments, the housing 102 may be, for example, a cylinder, a triangular prism, a square prism, a pentagonal prism, a cone, a pyramid, or any other suitable shape. Similarly, although the drainage element 104 is shown in FIGS. 1A and 1B as having a circular cross-sectional shape, in other embodiments, the drainage element 104 may have a cross-sectional shape that is, for example, oval, triangular, square, pentagonal, hexagonal, or any other suitable shape.

[0014] 1B, the first end portion 102a of the housing 102 further includes a housing inlet 108 that allows fluid to enter the housing 102. As described below with respect to FIGS. 1C and 1D, fluid entering the housing 102 via the housing inlet 108 can be selectively allowed to flow into the chamber 106. Once the fluid is in the chamber 106, it can be drained via the channel 105. For example, in some embodiments, the housing 102 is positioned at least partially within a first body region (e.g., the anterior chamber of a patient's eye) and the second end portion 104b of the drainage element is positioned at least partially within a second body region (e.g., a desired drainage location such as a bleb space), and the housing inlet 108 is configured to allow fluid (e.g., aqueous) to enter the housing 102 and drain from the chamber 106 through the drainage element 104 and into the second body region via the channel 105.

[0015] 1C, the amount of fluid flowing through the system 100 may be controlled by an actuation assembly 110. The actuation assembly 110 is positioned within the chamber 106 and includes one or more actuators (e.g., a first actuator 112a, a second actuator 112b, a third actuator 112c, and a fourth actuator 112d (collectively referred to as "actuators 112"). Labeling of features of the first actuator 112a, the second actuator 112b, and the third actuator 112c has been omitted from FIG. 1C solely for clarity, and each of the first actuator 112a, the second actuator 112b, and the third actuator 112c may be configured generally similarly or the same as the fourth actuator 112d. For example, each of the actuators 112 can include a generally elongated actuator body portion 114 ("actuator body 114") and a control element 116 configured to movably interface with a corresponding opening 124 (e.g., a fluid inlet, hereinafter referred to as "fluid inlet 124"), for example, to move between a first (e.g., open) position in which the control element 116 does not substantially prevent fluid from flowing through the fluid inlet 124 and a second (e.g., closed) position in which the control element 116 substantially prevents fluid from flowing through the fluid inlet 124. In some embodiments, the control element 116 can be configured to move between one or more intermediate positions between the first position and the second position. Movement of the control element 116 to the one or more intermediate positions can facilitate adjustment of fluid flow through the fluid inlet 124 to a flow rate above that of the second position (e.g., closed) but below that of the first position (e.g., fully open). In some embodiments, the actuator body 114 forms a continuous, unitary structure with the control element 116.

[0016] Each of the actuators 112 may further include a first (e.g., upper) actuating element 118a and a second (e.g., lower) actuating element 118b (collectively, "actuating elements 118") that drive movement of the control element 116 between a first position and a second position. The first actuating element 118a and the second actuating element 118b may be at least partially composed of a shape memory material or alloy (e.g., Nitinol). As such, the first actuating element 118a and the second actuating element 118b may be transitionable between at least a first material phase or state (e.g., a martensite state, an R-phase, a composite state between martensite and R-phase, etc.) and a second material phase or state (e.g., an austenite state, an R-phase state, a composite state between austenite and R-phase, etc.). In relation to the second material state, the first material state has reduced mechanical properties (e.g., Young's modulus) that make the body of the first material state more easily deformable (e.g., compressible, expandable, etc.) relative to the second material state. In the second material state, the first and second actuating elements 118a, 118b may have increased mechanical properties that result in an increased preference for a particular preferred geometry (e.g., original geometry, manufactured or fabricated geometry, heat-set geometry, etc.). The first and second actuating elements 118a, 118b may selectively and independently transition between the first and second material states by applying energy (e.g., heat, etc.) to the first and second actuating elements 118a, 118b to heat them above a transition temperature (e.g., an austenite finish temperature). When heated above a transition temperature, if the first actuating element 118a (or the second actuating element 118b) is deformed relative to its preferred geometric shape, the first actuating element 118a (or the second actuating element 118b) changes to and / or toward its preferred geometric shape.

[0017] The first actuating element 118a and the second actuating element 118b generally act in opposition. For example, the first actuating element 118a can be actuated to move the control element 116 to and / or toward the second position, and the second actuating element 118b can be actuated to move the control element 116 to and / or toward the first position. Additionally, the first actuating element 118a and the second actuating element 118b can be moved in unison with one another such that one changes toward its preferred geometry and the other deforms relative to its preferred geometry as the material undergoes a phase transition. This allows the actuating elements to be repeatedly actuated and the control element 116 to be repeatedly cycled between the first and second positions. Further details regarding the operation of shape memory actuators, as well as adjustable glaucoma shunts, are described in U.S. Pat. No. 11,291,585, U.S. Pat. No. 11,166,849, and International Application Nos. PCT / US20 / 55144, PCT / US20 / 55141, PCT / US21 / 14774, PCT / US21 / 18601, PCT / US21 / 23238, and PCT / US21 / 27742, the disclosures of all of which are incorporated herein by reference in their entireties for all purposes.

[0018] In some embodiments, the actuating elements 118 may be "stressed," "tensioned," "loaded," or otherwise deformed to their preferred geometries prior to use in a system such as system 100. For example, the first actuating element 118a and the second actuating element 118b may be contemporaneously or substantially simultaneously deformed from their preferred geometries to the same or substantially similar deformed (e.g., stressed, tensioned, compressed, etc.) geometries such that, for example, the first actuating element 118a and the second actuating element 118b may be actuated to move the actuator between the first and second positions as described above. Stressing of actuating elements is described in more detail below with reference to FIGS. 4A-4C.

[0019] The first actuating element 118a can include a first tab or target 120a, and the second actuating element 118b can include a second tab or target 120b (collectively, "targets 120"). The targets 120 can extend (e.g., laterally, horizontally, etc.) from the respective first and second actuating elements 118a, 118b. For example, the first target 120a can extend from the first actuating element 118a in a first direction, and the second target 120b can extend from the second actuating element 118b in a second direction different (e.g., opposite) from the first direction. Because the targets 120 extend in different directions relative to the actuating elements 118, the targets 120 are not aligned along a common (e.g., vertical) axis (e.g., the first target 120a is not "stacked" on the second target 120b) even though the actuating elements 118a-b are aligned along a common (e.g., vertical) axis (e.g., the first actuating element 118a is "stacked" on the second actuating element 118b). Thus, both targets 120 are expected to be accessible to energy (e.g., laser energy) even if the body of one of the actuating elements 118 is generally not directly accessible. Thus, the targets 120 can be used to selectively and independently actuate the first actuating element 118a and the second actuating element 118b (e.g., selectively heat the first actuating element 118a or the second actuating element 118b to transition from a first material state to a second material state). For example, to activate the first actuating element 118a, heat / energy can be applied to the first target 120a, such as from an energy source (e.g., a laser) positioned outside the patient's eye. The heat applied to the first target 120a can spread through at least a portion of the first actuating element 118a and heat the first actuating element 118a above its transition temperature. To actuate the second actuating element 118b, heat / energy can be applied to the second target 120b. The heat applied to the second target 120b can spread through the second actuating element 118b and heat at least a portion of the second actuating element 118b above its transition temperature.

[0020] In some embodiments, the first actuating element 118a and the second actuating element 118b are at least partially thermally and / or energetically isolated from one another, for example, to prevent or substantially limit the diffusion of energy applied to the target actuating element to the non-target actuating elements. Energy spreading to the non-target actuating elements may at least partially heat the non-target actuating elements, which may inadvertently induce a geometric change in the non-target actuating elements by changing the non-target actuating elements toward their preferred geometry. This is disadvantageous because the target actuating elements generally act in opposition to the non-target actuating elements, and thus the shape memory-based geometric change of the non-target actuating elements may affect the desired adjustment of the system 100, thereby reducing the control of the fluid flow through the system 100. Thus, the actuating assemblies and / or one or more features thereof described herein are expected to exhibit improved energy (e.g., thermal) isolation characteristics of the actuating elements, which may advantageously improve the control of the fluid flow through the system 100. For example, in the illustrated embodiment, the first actuating element 118a and the second actuating element 118b are positioned on opposite sides of the actuator body 114. The actuator body 114 and / or the control element 116 can be constructed from a material that is at least partially insulating. For example, the control element 116 can be constructed from a material that has a relatively low thermal conductivity and / or heat capacity, such as ceramic, carbon, glass, high molecular weight polymer (e.g., polyethylene terephthalate (PET)), etc., and / or a thermal conductivity and / or heat capacity that is less than the thermal conductivity and / or heat capacity of the actuating element 118. In some embodiments, the control element 116 may contain one or more coatings or layers (e.g., oxides, ceramics, carbon, glass, high molecular weight polymers, or other materials with low thermal conductivity) and / or have a high thermal mass (e.g., energy density) to reduce and / or prevent energy (e.g., heat) applied to the target actuating element from diffusing to non-target actuating elements.In at least some embodiments, the material comprising the actuator body 114 and / or the control element 116 can have sufficient mass to dissipate energy (e.g., heat) transferred from the first actuating element 118a and / or the second actuating element 118b to the actuator body 114 and / or the control element 116, so as to reduce and / or prevent heat transfer from the target actuating elements to the non-target actuating elements. In some embodiments, the first actuating element 118a and the second actuating element 118b can be separated by a gap (e.g., not physically coupled) to reduce and / or prevent heat transfer from the target actuating elements to the non-target actuating elements.

[0021] In embodiments where some energy does indeed diffuse from the target actuation element to other actuation elements, the diffusing energy (e.g., heat) is expected to be reduced in intensity (e.g., temperature) by the insulating actuator body 114, thereby not causing substantial heating of these other actuation elements relative to the target actuation element that directly receives the energy. Additionally, in some embodiments, each of the first actuation elements 118a can be insulated (e.g., thermally) from one another, and each of the second actuation elements 118b can be insulated (e.g., thermally) from one another. For example, each of the first actuation elements 118a can be coupled to one another by an insulating material (e.g., a material having a low thermal conductivity), and each of the second actuation elements 118b can be similarly insulated. In at least some embodiments, the insulating material coupling the first actuation elements 118a and the second actuation elements 118b can have sufficient mass to induce dissipation of energy, as discussed above.

[0022] In some embodiments, the actuator body 114 may also be stiffer or more rigid than the first and second actuating elements 118a, 118b, e.g., relative to the stiffness of the first and second actuating elements 118a, 118b at least in the first material state. For example, the actuator body 114 may be formed from a material having a stiffness greater than that of the first and second actuating elements 118a, 118b, and / or the geometry (e.g., width, thickness, etc.) of the actuator body 114 may be configured (e.g., wider, thicker, etc.) such that the actuator body 114 exhibits a stiffness greater than the first and second actuating elements 118a, 118b. This is expected to improve the consistency and / or magnitude of movement of the actuator body 114 and the control element 116. For example, this allows the actuating element 118 to be initially deformed to a preferred geometry without substantially deforming the actuator body 114 and the control element 116. This also allows the actuator body 114 and control element 116 to have consistent motion upon actuation of the actuation element 118. Thus, the actuator body 114 can be formed from a material that has greater rigidity than the actuation element 118. In at least some embodiments, the actuator body 114 can be insulating and have increased rigidity relative to the actuation element.

[0023] The actuation assembly 110 further includes a base 122 (e.g., a base plate). Referring now to FIG. 1D, the base 122 may include one or more fluid inlets and / or openings (e.g., a first fluid inlet 124a, a second fluid inlet 124b, a third fluid inlet 124c, and a fourth fluid inlet 124d, collectively "fluid inlets 124"). The fluid inlets 124 may be fluidly coupled to the housing inlet 108. For example, each of the fluid inlets 124 is connected by a corresponding channel to a fluid collection lumen 123 that receives fluid via the housing inlet 108 (e.g., first fluid inlet 124a by first channel 126a, second fluid inlet 124b by first channel 126b, third fluid inlet 124c by third channel 126c, and fourth fluid inlet 124d by fourth channel 126d, collectively "channels 126") to allow fluid to enter chamber 106 (for purposes of clarity, chamber 106 is not shown in FIG. 1D) from an environment external to system 100. Fluid entering housing inlet 108 can pass through channel 126 and the corresponding fluid inlet 124 to enter chamber 106.

[0024] Each of the actuators 112 is configured to control fluid flow through a corresponding fluid inlet 124. For example, the first actuator 112a is configured to control fluid flow through the first fluid inlet 124a, the second actuator 112b is configured to control fluid flow through the second fluid inlet 124b, the third actuator 112c is configured to control fluid flow through the third fluid inlet 124c, and the fourth actuator 112d is configured to control fluid flow through the fourth fluid inlet 124d. In the first position, the control element 116 of each of the actuators 112 does not substantially prevent and / or interfere with fluid flow through the corresponding fluid inlet 124. In the second position, the control element 116 of each of the actuators 112 can form a fluid seal with the corresponding fluid inlet 124, e.g., thereby substantially preventing or otherwise interfering with fluid flow through the fluid inlet 124. In some embodiments, the actuator control element 116 does not form a complete fluid seal in the second position, but rather allows for a leakage flow rate for a given pressure, e.g., ensuring that at least some flow through the system 100 is maintained even when the control element 116 is in the second position.

[0025] In operation, the system 100 can be used to drain aqueous humor from the anterior chamber of the eye to treat glaucoma. Thus, when the system 100 is implanted in the eye to treat glaucoma, the first end portion 102a of the housing 102 can be positioned in the anterior chamber of the patient's eye such that the housing inlet 108 is in fluid communication with the anterior chamber, and the second end portion 104b of the drainage element 104 can be positioned in a target outflow location, such as the subconjunctival bleb space, such that the channel 105 is in fluid communication with the target outflow location. As previously described, aqueous humor can flow into the housing 102 via the housing inlet 108, through the channel 126, the corresponding fluid inlet 124, and the actuation assembly 110, into the chamber 106, and out via the channel 105. In some embodiments, the orientation of the system 100 can be reversed, such that the housing 102 is positioned in the target outflow location and the second end portion 104b is positioned in the anterior chamber.

[0026] In some embodiments, the relative level of therapy provided by each of the fluid inlets 124 when not blocked by a corresponding actuator 112 may be the same. In some embodiments, the relative level of therapy provided by each of the fluid inlets 124 when not blocked by a corresponding actuator 112 may be different, allowing a user to selectively titrate flow through the system 100 by selectively impeding or allowing flow through individual fluid inlets 124. For example, under a given pressure, when flow occurs primarily through the first fluid inlet 124a, the system 100 may provide a first exhaust rate, when flow occurs primarily through the second fluid inlet 124b, the system 100 may provide a second exhaust rate that is lower than the first exhaust rate, when flow occurs primarily through the third fluid inlet 124c, the system 100 may provide a third exhaust rate that is lower than the second exhaust rate, and when flow occurs primarily through the fourth fluid inlet 124d, the system 100 may provide a fourth exhaust rate that is lower than the third exhaust rate. The aforementioned drainage rate differences can be achieved based on the different fluidic resistances of the channels 126a-d that receive fluid from their respective fluid inlets 124a-d. In some embodiments, the channels 126 can have different widths and / or lengths that result in different fluidic resistances. While the channels 126 shown in FIG. 1D are configured in parallel, in other embodiments, the channels 126 can be configured in series, for example, as described in International Application No. PCT / US21 / 14774, previously incorporated by reference herein.

[0027] 1C-1D as having four actuators 112a-d and four fluid inlets 124a-d, in other embodiments, the actuation assembly 110 can include more or fewer actuators 112 and fluid inlets 124. For example, the actuation assembly 110 can include one, two, three, five, six, seven, eight, or more actuators 112 and fluid inlets 124.

[0028] Figures 2A-2C show the actuation assembly 110 of Figure 1C, with other aspects of the system 100 described above with reference to Figures 1A-1D omitted for clarity. In particular, Figure 2A is a side view of the first actuator 112a in an unactuated position (after assembly, stressed, strained, loaded, compressed, etc.), Figure 2B is a side view of the first actuator 112a in a second (e.g., closed) position as described with respect to Figures 1A-1C, and Figure 2C is a side view of the first actuator 112a in a first (e.g., open) position as described with respect to Figures 1A-1C.

[0029] 2A, the actuation assembly 110 further includes a bracket or actuator mount 230 coupled to the base 122. The actuator body 114 includes a first end portion 114a including the control element 116 and a second end portion 114b at least partially received (e.g., insertably, releasably, fixedly, etc.) by the actuator mount 230. The first actuation element 118a and the second actuation element 118b are positioned between and contact the first end portion 114a and / or control element 116 of the actuator body 114 and the actuator mount 230. Interaction between the first actuation element 118a and the second actuation element 118b, the actuator body 114, and the actuator mount 230 can move the first actuator 112a from a first position toward and / or to a second position. 2A, the first actuating element 118a and the second actuating element 118b are deformed (e.g., compressed, stretched, stressed, etc.) equally, or at least generally equally. However, as described above, the first actuator 112a can be moved to the first or second position by applying energy (e.g., heat) to the first actuating element 118a or the second actuating element 118b.

[0030] 2B illustrates the actuator 112a after energy has been applied to the first actuator 118a (e.g., the first target 120a) to transition the first actuator 112a toward and / or to the second position. Relative to its configuration in FIG. 2A, the first actuating element 118a has expanded toward its preferred geometry and acts against the actuator mount 230 and the first end portion 114a of the actuator body 114 to pivot the actuator body 114 relative to the actuator mount 230 and move the control element 116 toward (e.g., into contact with) the first fluid inlet 124a. Upon contacting the first fluid inlet 124a, the control element 116 can substantially prevent fluid flow through the first fluid inlet 124a (e.g., by forming a substantially fluid seal). As the first actuator 112a transitions toward the second position, the second actuating element 118b can be deformed (e.g., compressed) relative to its configuration in FIG. 2A. This may allow the second actuating element 118b to act in opposition to the first actuating element 118a, as previously described.

[0031] 2C illustrates the actuator 112a after energy has been applied to the second actuating element 118b (e.g., the second target 120b, not shown in FIG. 2C for clarity) to transition the first actuator 112a from the second position of FIG. 2B toward the first position. Relative to its configuration in FIG. 2B, the second actuating element 118b has expanded toward and / or to its preferred geometry and acts against the first end portion 114a of the actuator body 114 to pivot the actuator body 114 relative to the actuator mount 230 and move the control element 116 away from the first fluid inlet 124a. In the first position, the control element 116 does not substantially prevent fluid flow through the first fluid inlet 124a (e.g., no fluid seal is formed). As the first actuator 112a moves toward and / or into the first position, the first actuating element 118a may be deformed (e.g., compressed) relative to its configuration in Figure 2B. This can enable the first actuating element 118a to act in opposition to the second actuating element 118b, as described above.

[0032] As shown and described above with respect to FIGS. 2A-2C, the control element 116 is configured to move in a plane substantially parallel to the central axis A extending through the first fluid inlet 124a (as opposed to sliding on the fluid inlet 124a by moving in a plane perpendicular to the central axis A extending through the first fluid inlet). For example, the movement of the control element 116 may be aligned perpendicular to the central axis extending through the first fluid inlet 124a or axially such that in the second position (as shown in FIG. 2B), for example, the control element 116 at least partially contacts (e.g., presses against) the first fluid inlet 124a to substantially prevent fluid flow through the first inlet 124a. As one skilled in the art will appreciate from the disclosure herein, in some embodiments, the control element 116 may not move along a completely linear path, but rather along a slightly arcuate path when moving between the first and second positions. Such arcuate motion remains substantially parallel to central axis A and is considered to be vertically / axially aligned for purposes of this disclosure. Without wishing to be bound by theory, it is believed that an improved fluid seal is formed when the motion of the control element and / or the force applied by the control element is aligned (e.g., vertically, axially, linearly, etc.) with the fluid inlet. Thus, in at least some embodiments, the actuation assemblies described herein are expected to exhibit improved fluid sealing performance. This can advantageously improve control of fluid flow through system 100.

[0033] Although described in the context of the first actuator 112a, the description of Figures 2A-2C applies equally to the second, third, and fourth actuators 112b-d of Figure 1C. In some embodiments, one or more of the actuators 112 of Figure 1C are actuated in unison to achieve a desired fluid flow rate through the actuation assembly 110. Additionally, while the first actuator 112a is described as operating under compression (e.g., the first and second actuating elements 118a, 118b expand toward their preferred geometries upon actuation), in other embodiments, the first actuator 112a can be configured to operate under tension (e.g., the first and second actuating elements 118a, 118b contract or shorten toward their preferred geometries upon actuation).

[0034] 3A and 3B illustrate an actuation assembly 310 configured in accordance with selected embodiments of the present technology. The actuation assembly 310 may include elements generally similar or the same as the actuation assembly 110 of FIGS. 1A-2C. Thus, like numbers are used to designate like elements (e.g., actuator 312 vs. first actuator 112a), and the description of FIGS. 3A and 3B is limited to features that differ from FIGS. 1A-2C and any additional aspects necessary for the context. Thus, the description of the actuation assembly 310 with respect to FIGS. 3A and 3B applies equally to the actuation assembly 110 of FIGS. 1A-2C.

[0035] 3A , actuation assembly 310 includes an actuator 312 having a first (e.g., upper) actuation element 318a, a second (e.g., lower) actuation element 318b, and a control element 316 aligned (e.g., vertically, axially, linearly, etc.) with a fluid inlet 324. Actuation assembly 310 further includes fluid inlet 324 and a membrane or sealing element 340 positioned between fluid inlet 324 and control element 316. Sealing element 340 may be or include an elastomer (e.g., silicone, polymethylmethacrylate ("PMMA"), polydimethylsiloxane ("PDMS"), etc.), or any other suitable material that, when pressed against / into fluid inlet 324, prevents or reduces fluid from flowing through inlet 324. 3A , the control element 316 can contact the sealing element 340 such that the sealing element 340 abuts the fluid inlet 324 and substantially prevents or reduces fluid flow through the fluid inlet 324. It is expected that the inclusion of the sealing element 340 can further improve the prevention of fluid flow through the fluid inlet 324.

[0036] 3B shows the actuator 312 in a first (e.g., open) position. In the first position, the control element 316 is moved away from the sealing element 340 such that the sealing element 340 does not substantially prevent or reduce fluid flow through the fluid inlet 324. As previously described, the actuator 312 can be used to control fluid flow through the actuation assembly 310.

[0037] 4A-4C are diagrams of an actuation assembly 410 configured in accordance with selected embodiments of the present technology. The actuation assembly 410 may include elements generally similar or the same as the actuation assembly 110 of FIGS. 1A-2C and / or the actuation assembly 310 of FIGS. 3A-3B. Accordingly, similar numbers are used to designate similar elements (e.g., first actuator 412a vs. actuator 312, first actuator 112a), and the description of FIGS. 4A-4B is limited to features that differ from FIGS. 1A-3B, and any additional aspects necessary for the context. Thus, the description of the actuation assembly 410 of FIGS. 4A-4B applies equally to the actuation assembly 110 of FIGS. 1A-2C and / or the actuation assembly 310 of FIGS. 3A-3B.

[0038] 4A is a perspective view of an actuation assembly 410 at a stage in a manufacturing process. The actuation assembly 410 includes one or more actuators 412 (e.g., a first actuator 412a, a second actuator 412b, a third actuator 412c, and a fourth actuator 412d). Each of the actuators 412a-d includes a first or upper actuation element 418a, a second or lower actuation element 418b, and an actuator body 414. At least a portion of a second end portion 414b of the actuator body 414 can be received (e.g., insertably, releasably, fixedly, etc.) by a corresponding opening 432 in an actuator mount 430. The actuation assembly 410 may further include a base plate 422, and each of the actuators 412 may be positioned on the base plate 422 (not shown in FIG. 4A for clarity, but e.g., aligned with a fluid inlet) and / or one or more sealing elements 440 (which may, e.g., be the same as or substantially similar to the sealing element 340 described above with reference to FIGS. 3A and 3B). At a later stage in the manufacturing process, the actuator mount 430 may be moved towards the control element 416 to contact the actuator body support 456. As described in more detail below, this may distort the first and second actuation elements 418a and 418b, for example, by deforming the first and second actuation elements 418a and 418b relative to their preferred geometry.

[0039] 4B is an exploded view of the actuator 412 of FIG. 4A with other aspects of the actuation assembly 410 omitted for clarity. The actuator 412 can be formed from one or more sheets / elements that can be manufactured separately. For example, the actuator 412 can be formed from a first or top sheet 458a, a second or bottom sheet 458b, and a third or middle sheet 454. The first sheet 458a can include one or more first actuation elements 418a coupled to a first actuation element support 460a, the second sheet 458b can include one or more second actuation elements 418b coupled to a second actuation element support 460b, and the third sheet 454 can include one or more actuator bodies 414, control elements 416, and end portions 414b coupled to the actuator body support 456. The first sheet 458a, the second sheet 458b, the third sheet 454, and the actuator mount 430 may be configured to be combined (e.g., assembled) in a predetermined configuration and / or order. For example, to assemble the actuation assembly 410, the first sheet 458a and the second sheet 458b may be positioned on either side of the third sheet 454, at least partially between the control element 416 and the actuator mount 430, such that the first actuation element support 460a and the second actuation element support 460b contact (e.g., are received within) the actuator mount 430, as illustrated in FIG.

[0040] Notably, each of the first actuating element 418a and the second actuating element 418b can be deformed (e.g., automatically and / or simultaneously) to its preferred geometry when the first sheet 458a, the second sheet 458b, and the third sheet 454 are coupled to the actuator mount 430. During the assembly process, each of the first actuating element 418a and the second actuating element 418b is positioned between the control element 416 and its actuator mount 430, as shown, for example, in FIG. 4A. For example, prior to assembly, each of the first sheet 458a and the second sheet 458b can have a first length L1, and the portion of the third sheet 454 including the actuator body 414 and the actuator body support 456 can have a second length L2 that is shorter than the first length L1. Thus, when the sheets are stacked as shown in FIG. 4A, the actuation element 418 extends between and contacts both the control element 416 and the actuator mount 430, while the second end portion 414b of the actuator body 414 is at least partially spaced from the actuator mount 430 by a gap G, as best shown in FIG. 4C, which is an enlarged side view of a portion of the actuation assembly 410 shown in FIG. 4A. As a result, moving the actuator mount 430 toward the control element 416 so that the second end portion 414b of the actuator body 414 is received within a corresponding opening 432 of the actuator mount 430, and / or moving the actuator mount 430 toward the actuator body support 456 so that the actuator mount 430 contacts the actuator body support 456, causes each of the first actuating element 418a and the second actuating element 418b to deform toward a preferred shape, e.g., deforming the first actuating element 418a and the second actuating element 418b (e.g., the actuating elements 418 may compressively flex outwardly relative to the actuator body 414, as shown in FIG. 1C ). This may allow the first actuating element 418a and the second actuating element 418b to be used in opposition to one another, e.g., as part of an actuation assembly and / or system, as described above.

[0041] Incorporating an actuation assembly as described above into an adjustable shunt system is expected to provide several advantages. For example, many of the components required to manufacture an adjustable shunt system capable of providing titratable and adjustable therapy are very small and difficult to manufacture using conventional techniques for molding plastic, steel, or other opaque materials. In contrast, utilizing an actuation assembly as described herein is expected to reduce manufacturing complexity. For example, the sheets of an actuation assembly (e.g., sheets 454, 458a-b of actuation assembly 410 in FIG. 4B) can be formed by known techniques for manufacturing materials with relatively high resolution (e.g., about 10 microns or less) and high repeatability. Additionally, as previously described, assembling prefabricated sheets into an actuation assembly can stress and / or deform the actuation elements, for example, so that the actuation elements can be used in opposition to one another to control fluid flow through the actuation assembly, thereby simplifying the manufacturing process.

[0042] The present technology further includes methods of manufacturing the actuation assemblies described herein. For example, FIG. 4D is a block diagram of a method 480 for making an actuation assembly according to an embodiment of the present technology. The method 480 can continue in step 481 by manufacturing a first sheet from a first material. This can include forming one or more actuation elements in the first sheet, such as, for example, first sheet 458a of FIG. 4B. The first sheet can be formed from a shape memory material, such as Nitinol, and may be formed via any suitable process (e.g., 3D printing) having relatively high resolution. The first sheet can be formed with the specific features described above, such as the target, the actuation element support, etc.

[0043] The method 480 may continue in step 482 by producing a second sheet from the first material. The second sheet may include one or more second actuating elements, such as second sheet 458b in FIG. 4B. Step 482 may be substantially similar or identical to step 481.

[0044] The method 480 may continue at step 483 by forming a third sheet from the second material. The third sheet may include one or more actuator bodies, such as third sheet 454 of Figure 4B. The second material may have increased rigidity relative to the first material and / or may have a lower conductivity (e.g., thermal conductivity) relative to the first material.

[0045] The method 480 may continue by forming an actuator mount from a third material at step 484. The actuator mount may include one or more apertures, such as actuator mount 430 of Figures 4A-4B. The third material may be the same or a different material than the second material.

[0046] The method 480 may continue by combining the first sheet, the second sheet, the third sheet, and the actuator mount, at step 485. Each of the first sheet, the second sheet, the third sheet, and the actuator mount may be configured to be combined in a predetermined configuration, for example, as described above with respect to Figures 4A-4B.

[0047] Method 480 may continue in step 486 by deforming one or more of the first and second actuating elements relative to their preferred geometries. In some embodiments, steps 485 and 486 may be combined (e.g., combining the first sheet, second sheet, third sheet, and actuator mount in a predetermined configuration (e.g., step 485) deforms (e.g., automatically deforms) the first and second actuating elements relative to a preferred geometry). As previously discussed, this may stress the first and second actuating elements for use in a system such as system 100 of FIGS. 1A-1D.

[0048] 5A-5C are diagrams of an actuation assembly 510 configured in accordance with selected embodiments of the present technology. The actuation assembly 510 may include elements that are generally similar or substantially identical to the actuation assembly 110 of FIGS. 1A-2C, the actuation assembly 310 of FIGS. 3A-3B, and / or the actuation assembly 410 of FIGS. 4A-4B. Accordingly, similar numbers are used to designate similar elements (e.g., first actuator 512a vs. first actuator 412a, actuator 312, first actuator 112a), and the description of FIGS. 5A-5C is limited to features that differ from FIGS. 1A-4B and any additional aspects necessary for the context. Accordingly, the description of the actuation assembly 510 of FIGS. 5A-5C applies equally to the actuation assembly 110 of FIGS. 1A-2C, the actuation assembly 310 of FIGS. 3A-3B, and / or the actuation assembly 410 of FIGS. 4A-4B.

[0049] 5A is a top view of an actuation assembly 510. The actuation assembly 510 may be received and housed by a housing 502, for example, within a chamber 506 of the housing 502. The housing 502 may be fluidly coupled to an environment outside the housing 502 by a housing inlet 508. The actuation assembly 510 may include one or more actuators (e.g., a first actuator 512a, a second actuator 512b, a third actuator 512c, and a fourth actuator 512d, collectively "actuators 512"). Each of the actuators 512 includes an actuator body 514, a first actuation element 518a, and a second actuation element 518b. The first actuation element 518a includes a first target 520a, and the second actuation element 518b includes a second target 520b. The first target 520a and the second target 520b can be positioned at or near the midpoint of the respective actuation elements 518a-518b. As described in more detail below with respect to FIGS. 6A-6B, the first target 520a and the second target 520b can be configured to receive energy (e.g., heat) to actuate the respective first actuation elements 518a and the second actuation elements 518b to control fluid flow through the actuation assembly 510. The actuator body 514 can include a flared end portion 515 having a width greater than a width of the actuator body 514. Although shown in FIG. 5A as having a semicircular shape, in other embodiments, the flared end portion 515 can have other shapes. For example, the flared end portion 515 can be circular, triangular, square, rectangular, etc., or any other suitable shape.

[0050] The actuation assembly 510 may further define a number of wells 560 corresponding to the actuators 512, such that each of the actuators 512a-d may be positioned within the wells 560. Each of the wells 560 may include a well inlet 562 fluidly coupled to the housing inlet 508, such that each of the wells 560 may be fluidly coupled to an environment external to the housing 502. Each of the wells 560 may further include a first chamber 564a and a second chamber 564b. Both the first chamber 564a and the second chamber 564b may be configured to receive (e.g., insertably, releasably, fixedly, etc.) the flared end portion 515 of the actuator body 514, such that the flared end portion 515 may be positioned in either the first chamber 564a or the second chamber 564b. For example, the actuation assembly 510 may be manufactured with the flared end portion 515 positioned within the first chamber 564a. As described in more detail below, moving the flared end portion 515 from the first chamber 564a to the second chamber 564b can cause the first actuating element 518a and the second actuating element 518b to deform (e.g., compress or stretch) relative to their preferred geometry. In some embodiments, the actuating assembly 510 can be a unitary or continuous structure (e.g., cut from, printed as, or deposited as a single piece of material). For example, each of the actuators 512 can be patterned (e.g., cut, laser cut, formed, etc.) in a single piece of material (e.g., Nitinol), and the wells 560 can correspond to areas of the single piece of material that have been removed (e.g., during a subtractive manufacturing process) or where no material has been added (e.g., during an additive manufacturing process).

[0051] 5B and 5C are top views of the actuation assembly 510 of FIG. 5A. In particular, FIG. 5B illustrates the actuation assembly 510 in an "as-formed" and / or "unstressed" configuration, and FIG. 5C illustrates the actuation assembly 510 in a "stressed," "strained," "loaded," and / or "deformed" configuration. Referring first to FIG. 5B, in the pre-stressed configuration, the flared end portion 515 is positioned within the first chamber 564a, and the first and second actuation elements 518a, 518b are not substantially deformed relative to their preferred geometric shapes. Referring now to FIG. 5C, the flared end portion 515 has been moved into the second chamber 564b to place the actuation assembly in a stressed configuration. Moving the flared end portion 515 into the second chamber 564b compresses the actuation element 518 and deflects it away from the actuator body 514, thereby deforming the actuation element 518 relative to the configuration of FIG. 5B. Thus, moving the flared end portion 515 from the first chamber 564a to the second chamber 564b can stress the first and second actuating elements 518a, 518b, for example, deforming the first and second actuating elements 518a, 518b relative to their preferred geometries such that the first and second actuating elements 518a, 518b are used to act against each other, as described above. Additionally, as described in more detail with respect to Figures 6A and 6B, the interaction between the flared end portion 515 and the second chamber 564b can enable the actuator body 514 to bend or pivot relative to the second chamber 564b, for example, to transition from a first (e.g., open) position to a second (e.g., closed) position. 5B and 5C illustrate the actuation assemblies in a preloaded configuration and a loaded configuration, respectively, in other embodiments, the configuration shown in FIG. 5C is a prestressed configuration and the configuration shown in FIG. 5B is a stressed configuration. In such embodiments, the actuation elements are deformed (e.g., stretched) relative to their preferred geometry by moving the flared end portion 515 from the second chamber 564b to the first chamber 564a.Thus, the actuation assembly 510 shown in Figures 5A-5C can include one or more actuators 512 configured to operate under compression (e.g., when Figure 5B is the unstressed configuration and Figure 5C is the loaded or stressed configuration), tension (e.g., when Figure 5C is the unstressed configuration and Figure 5B is the loaded or stressed configuration), and / or combinations thereof.

[0052] 6A and 6B show views of the first actuator 512a (e.g., with the flared end portion 515 positioned in the second receiving chamber 564b) of FIG. 5C with other aspects of the actuation assembly 510 omitted for clarity. In the illustrated embodiment, the first target 520a and the second target 520b are generally configured similarly or identically to the targets 120a-b of FIG. 1C, with the second target 520b further configured as a control element, for example, for controlling fluid flow. For example, referring initially to FIG. 6A, the first actuator 512a is in a first position such that the second target 520b does not substantially impede the fluid flow through the first fluid inlet 524a. In some embodiments, the first target 520a can at least partially contact an inner surface of the well 560 when the first actuator 512a is in the first position.

[0053] 6B, the first actuator 512a is transitioned to a second position such that the second target 520b substantially obstructs fluid flow through the first fluid inlet 524a. Energy (e.g., heat) applied to the first target 520a and / or the first actuating element 518a can transition the first actuating element 518a toward its preferred geometry, which can cause the actuator body 514 to bend or pivot relative to the second receiving chamber 564b and move the second target 520b into contact with the first fluid inlet 524a. In at least some embodiments, the second target 520b can at least partially deform (e.g., flex, bend, pivot, move, etc.) a side or wall 525 of the first fluid inlet 524a such that the wall 525 at least partially blocks the first fluid inlet 524a, e.g., substantially preventing fluid flow through the first fluid inlet 524a. To return to the first position, energy may be applied to the second target 520b and / or the second actuating element 518b, causing the second actuating element 518b to transition toward its preferred geometry and the first actuating element 518a to deform, as described above. In embodiments including the wall 525, the wall 525 may be generally elastic or at least partially resistant to deformation, such that the wall 525 returns to a configuration that does not substantially impede fluid flow through the first inlet when the first actuator 512a returns to the first position. In some embodiments, the second target 520b moves in a direction generally axially aligned with the first fluid inlet 524a, e.g., as described above with reference to the control element 116 of Figures 2A-2C. Thus, the second target 520b is expected to exhibit the same or substantially similar improved sealing performance as the control element 116 of Figures 2A-2C.

[0054] 7A and 7B show views of the first actuator 512a of FIGS. 6A and 6B, with certain aspects of the first actuator 512a omitted for clarity. Referring first to FIG. 7A, the first actuator 512a is in a first position such that the second target 520b does not substantially impede fluid flow through the first fluid inlet 524a. Referring now to FIG. 7B, the first actuator 512a has been transitioned to a second position such that the second target 520b contacts the first fluid inlet 524a and substantially prevents fluid flow through the first fluid inlet 524a. In the illustrated embodiment, the first fluid inlet 524a is formed from a flexible and / or elastomeric material such that the first fluid inlet 524a can be at least partially deformed when the second target 520b is in the second position. 3A-3B, the deformability of the first fluid inlet 524a is expected to improve the fluid seal formed between the second target 520b and the fluid inlet 524a when in the second position. The first fluid inlet 524a may be formed from any flexible material, such as an elastomer, or any other suitable material capable of forming a substantial fluid seal with the second target 520b.

[0055] 8A and 8B are top views of an actuation assembly 810 configured in accordance with an embodiment of the present technology. More specifically, FIG. 8A illustrates the actuation assembly 810 in a first state or configuration, and FIG. 8B illustrates the actuation assembly 810 in a second, different state or configuration. The actuation assembly 810 can include at least some aspects that are generally similar or identical in structure and / or function to the actuation assembly 110 of FIGS. 1C, 2A-2B, the actuation assembly 310 of FIGS. 3A-3B, the actuation assembly 410 of FIGS. 4A-4C, and / or the actuation assembly 510 of FIGS. 5A-5C, described above. Accordingly, similar names and / or reference numbers (e.g., actuating elements 118a and 118b as opposed to actuating elements 818a and 818b, actuating elements 318a and 31b, actuating elements 418a and 418b, and / or actuating elements 518a and 518b) are used to indicate aspects that may be generally similar or identical in structure and / or function.

[0056] 8A and 8B together, the actuation assembly 810 includes at least one actuator 812 ("actuator 812"). The actuator 812 can be formed from a single sheet of material and can include a first body portion 814a, a second body portion 814b, and one or more actuation elements 818 extending between the first body portion 814a and the second body portion 814b (individually identified as a first actuation element 818a and a second actuation element 818b). In some embodiments, the actuation assembly 810 can be configured to receive a fluid (e.g., aqueous) via one or more fluid inlets 808, which can be positioned at least partially between the first body portion 814a and the second body portion 814b or in another suitable location. Fluid received via one or more of the fluid inlets 808 can enter the chamber 806. The chamber 806 can include a first chamber portion or region 864a and a second chamber portion or region 864b. In the illustrated embodiment, the first chamber portion 864a and the second chamber portion 864b define opposing ends of the chamber 806. However, in other embodiments, the first chamber portion 864a and / or the second chamber portion 864b can have other suitable configurations.

[0057] The actuator 812 can be positioned within the chamber 806 and can be configured to control the flow of fluid therethrough. More specifically, the first body portion 814a can be configured to be received within the first chamber portion 864a. In some embodiments, the first body portion 814a includes a first flared end portion 815a configured to contact one or more surfaces of the first chamber portion 864a. Additionally or alternatively, the first body portion 814a can include an inner retaining surface 817 configured to contact a retaining feature or tab 866 positioned at least partially within and / or proximate to the first chamber portion 864a. In the illustrated embodiment, for example, the retaining surface 817 is positioned between actuating elements 818a and 818b and first body portion 814a and includes two first flared end portions 815a, one on each side of the retaining surface 817, such that each of the actuating elements 818a-b is positioned between a corresponding one of the first flared end portions 815a and the retaining surface 817.

[0058] The second body portion 814b can include a control element portion 816 and a second flared end portion 815b. The control element portion 816 can include one or more control elements 816a and 816b (individually identified as a first control element 816a and a second control element 816b). Each of the control elements 816a and 816b can be configured to control fluid flow through one or more channels 826 (individually identified as a first channel 826a and a second channel 826b) by movably interfacing with a corresponding channel opening or fluid inlet 824 of the channel 826 (individually identified as a first fluid inlet 824a and a second fluid inlet 824b). In the illustrated embodiment, for example, each of the control elements 816a and 816b is configured to be at least partially insertable into and form a substantially fluid-tight seal with a corresponding fluid inlet 824a and a fluid inlet 824b. In some aspects of the present technology, the control elements 816a and 816b are expected to form an improved seal with the fluid inlets 824, at least due to movement of the control elements 816a and 816b relative to the corresponding fluid inlets 824a and 824b and / or because the control elements 816a and 816b may be at least partially inserted into the corresponding fluid inlets 824a and 824b. In some embodiments, one or more sealing elements, such as the sealing element 340 of Figures 3A and 3B, can be positioned between the control elements 816a and 816b and the corresponding fluid inlets 824a and 824b, for example, to further improve the seal formed between the control elements 816a and 816b and the fluid inlets 824a and 824b. Thus, the channels 826 of the actuation assembly 810 are expected to have improved fluid and / or leak resistance when the corresponding control elements 816a and 816b are positioned (e.g., engaged, sealed, closed, and / or the like) within the associated fluid inlets 824.

[0059] In the illustrated embodiment, the control element portion 816 is transitionable between a first position (shown in FIG. 8A) and a second position (shown in FIG. 8B). In these and other embodiments, the control element portion 816 can be configured to transition to one or more other positions, such as a third position or an intermediate position between the first and second positions. In the first position (FIG. 8A), the first control element 816a is sealingly engaged with the first fluid inlet 824a to substantially prevent fluid from flowing therethrough, and the second control element 816b is spaced from the second fluid inlet 824b to allow fluid to flow therethrough. In the second position (FIG. 8B), the first control element 816a is spaced from the first fluid inlet 824a to allow fluid to flow therethrough, and the second control element 816b is sealingly engaged with the second fluid inlet 824b to substantially prevent fluid from flowing therethrough. Thus, it is expected that at least one of the fluid inlets 824a-b will be at least partially open to fluid flow regardless of whether the control element portion 816 is in a first or second state such that under a given pressure, the actuation assembly 810 can provide a non-zero flow rate through at least one of the inlets 824a and 824b. In some embodiments, one or more of the control elements 816a and 816b do not form a complete fluid seal with the respective fluid inlets 824a and 824b, but rather allow a leak flow rate for a given pressure, e.g., ensuring that at least some flow through both the channels 826a and 826b is maintained even when the control elements 816a and 816b are positioned (e.g., engaged, sealed, closed, and / or the like) within the respective fluid inlets 824a and 824b. In these and other embodiments, the control element portion 816 may be configured to move between one or more intermediate positions between the first position and the second position.

[0060] The second flared end portion 815b can be configured to be positioned at least partially within the second chamber portion 864b. In some embodiments, the second body portion 814b can include a joint or pivot feature 819 about which the control element portions 816a and 816b can pivot / rotate as the control element portion 816 transitions between the first and second positions. The pivot feature 819 can be positioned between the second flared end portion 815b and the control element portion 816 such that the control element portion 816 can rotate / pivot relative to the second flared end portion 815b about the pivot feature 819. Additionally, in the illustrated embodiment, a pivot feature 819 is positioned between the first control element 816a and the second control element 816b such that the control element portion 816 is transitionable from a first position (FIG. 8A) to a second position (FIG. 8B) by pivoting the control element portion 816 relative to the second flared end portion 815b and rotating the first control element 816a and the second control element 816b in a clockwise direction about the pivot feature 819. With continued reference to the illustrated embodiment, the control element portion 816 is transitionable from the second position (FIG. 8B) to the first position (FIG. 8A) by pivoting the control element portion 816 relative to the second flared end portion 815b and rotating the first control element 816a and the second control element 816b in a counterclockwise direction about the pivot feature 819. Rotation of control elements 816a and 816b about pivot feature 819 can be driven by actuating actuation element 818 as described in more detail below.

[0061] In some aspects of the present technology, the control element portion 816 may be stable (e.g., "bistable") or otherwise generally resistant to movement in both the first and second positions, since at least one of the control elements 816a and 816b engages a corresponding one of the fluid inlets 824a and 824b in both the first and second positions. Although the actuation element 818 is generally expected to hold the control element portion 816 in the first and / or second positions unless / until the actuation element 818 is actuated (described in more detail below), the engagement between the control elements 816a and 816b and the fluid inlets 824a and 824b in both the first and second positions is expected to further reduce or prevent undesired movement of the control element portion 816, such as rocking or vibrating in response to movement of the actuation assembly 810.

[0062] The actuating elements 818a and 818b can generally act in opposition, each of which can be actuated to move the control elements 816a and 816b and transition the control element portion 816 between a first position and a second position. In the illustrated embodiment, for example, when the control element portion 816 is in the first position, the second actuating element 818b can be actuated to move the control element portion 816 toward and / or to the second position, and when the control element portion 816 is in the second position, the first actuating element 818a can be actuated to move the control element portion 816 toward and / or to the first position. Each of the actuating elements 818a and 818b can include a respective target 820 (individually identified as a first target 820a and a second target 820b). The target 820 can extend (e.g., laterally, horizontally, etc.) from each actuating element 818 and can be configured to receive energy (e.g., laser energy) from an energy source external to the patient to selectively and independently actuate each actuating element 818a-b.

[0063] The actuating elements 818 can be "stressed," "distorted," "loaded," or deformed relative to their preferred geometry by disposing the first and second body portions 814a, 814b in the respective first and second chambers 864a, 864b. In the illustrated embodiment, for example, the first and second chambers 864a, 864b are spaced apart such that disposing the first body portion 814a in the first chamber portion 864a and disposing the second flared end portion 815b of the second body portion 814b in the second chamber portion 864b can distort or stretch the actuating elements 818 extending therebetween, thereby deforming the actuating elements 818 relative to their preferred / original shape. First and second flared end portions 815a, 815b may each be configured to maintain actuator 812 in this strained / stretched state, for example, by contacting respective surfaces within corresponding first and second chambers 864a, 864b that prevent first and second body portions 814a, 814b from moving toward one another. Additionally or alternatively, retaining surface 817 may be configured to maintain actuator 812 in a tensioned / stretched state, for example, by contacting retaining feature 866 to prevent first and second body portions 814a, 814b from moving toward one another.

[0064] 8A and 8B are shown as operating under tension (e.g., elongated / strained relative to their preferred geometry), in other embodiments, the actuator 812 can be configured to operate under compression such that the first body region 814a and the second body region 814b can be advanced toward one another to shorten or compress the actuating elements 818 relative to their preferred geometry. Additionally, while the actuation assembly 810 includes one actuator 812 having two control elements 816a and 816b corresponding to the two fluid inlets 824a and 824b in the embodiment shown in FIGS. 8A and 8B, in other embodiments, the actuation assembly 810 can include more actuators 812, each of which can include more or fewer control elements 816a and 816b and / or fluid inlets 824. In at least some embodiments, the number of control elements 816a and 816b can be equal to the number of fluid inlets 824.

[0065] 9A and 9B are top views of an actuation assembly 910 configured in accordance with further embodiments of the present technology. More specifically, FIG. 9A illustrates the actuation assembly 910 in a first state or configuration, and FIG. 9B illustrates the actuation assembly 910 in a second, different state or configuration. The actuation assembly 910 can include at least some aspects that are generally similar or identical in structure and / or function to the actuation assembly 110 of FIGS. 1C, 2A, and 2B, the actuation assembly 310 of FIGS. 3A and 3B, the actuation assembly 410 of FIGS. 4A-4C, the actuation assembly 510 of FIGS. 5A-5C, and / or the actuation assembly 810 of FIGS. 8A and 8B. Accordingly, similar names and / or reference numbers (e.g., actuating elements 918a and 918b versus actuating elements 118a and 118b, actuating elements 318a and 318b, actuating elements 418a and 418b, actuating elements 518a and 518b, and / or actuating elements 818a and 818b) are used to indicate aspects that may be generally similar or identical in structure and / or function.

[0066] 9A and 9B together, the actuation assembly 910 may be formed from a single sheet of material and may include one or more body regions 970 (individually identified as a first body region 970a and a second body region 970b), one or more charging or priming arms 972 (individually identified as a first priming arm 972a and a second priming arm 972b), and one or more actuators 912 (individually identified as a first actuator 912a and a second actuator 912b). One or more of the priming arms 972 may include at least one groove or notch 976. Each of the actuators 912 may extend between the first body region 970a and the second body region 970b and may include one or more actuation elements 918 (individually identified as a first actuation element 918a and a second actuation element 918b). In the illustrated embodiment, a first priming arm 972a is coupled to a left side of the first body region 970a and the second body region 970b, and a second priming arm 972b includes a notch 976 and is coupled to a right side of the first body region 970a and the second body region 970b, such that the body regions 970a-b and the priming arms 972a-b define a priming frame or assembly 971 that extends around the actuator 912. In other embodiments, one or both of the priming arms 972 can have different configurations. In at least some embodiments, for example, the first priming arm 972a can include at least one notch 976 and the second priming arm 972b can be notchless, or both the first priming arm 972a and the second priming arm 972b can have the same configuration (e.g., both include at least one notch 976 or both are notchless).

[0067] The priming frame 971 can be configured to distort / deform the actuating elements 918 relative to their preferred / original geometry. In the illustrated embodiment, for example, the priming arms 972a and 972b can bend or flex (e.g., inwardly, laterally, and / or the like) along a first axis, as shown by arrow L, from a first position ( FIG. 9A ) to a second position ( FIG. 9B ). The bending / flexing of the priming arms 972a and 972b can thereby move one or more of the body regions 970a and 970b along a second axis, as shown by arrow V (e.g., outwardly, vertically, and / or the like), to transition the actuating assembly 910 between the first state ( FIG. 9A ) and the second state ( FIG. 9B ). When the actuating assembly 910 is in the first state, the actuating elements 918 can be at or near their preferred geometry, as shown in FIG. 9A . When actuation assembly 910 is in the second state, actuation elements 918 may be stretched or otherwise deformed relative to their preferred (e.g., as-manufactured) geometry, as shown in FIG. 9B. Additionally or alternatively, actuation assembly 910 may be transitioned from the first state (FIG. 9A) to the second state (FIG. 9B) by moving one or more of body regions 970a-b along a second axis (as shown by arrow V), thereby deforming actuation elements 918 relative to their preferred geometry. One or more of priming arms 972a and 972b may then bend / flex from the first position toward the second position, fixing / locking actuation assembly 910 in the second state and / or at least partially inhibiting or preventing body regions 970a and 970b from moving back toward the first state.

[0068] Each of the priming arms 972a and 972b can be configured to be stable or otherwise generally resistant to bending / flexing in their respective first and second positions. In at least some embodiments, for example, the priming arm 972 can be configured to lock or snap into the inwardly deflected second position shown in FIG. 9B in response to movement of the priming arm 972 in the direction indicated by arrow L (FIG. 9A). A notch 976 in the second priming arm 972b can further improve the stability of the second priming arm 972b, for example, by reducing resistance to inward deflection of the second priming arm 972b as the actuation assembly transitions between the first and second states.

[0069] In the illustrated embodiment, when actuating assembly 910 is in the first state (FIG. 9A), priming arm 972 defines a first width of actuating assembly 910 and body region 970 defines a second width that is less than the first width. Thus, in some embodiments, actuating assembly 910 can be transitioned from the first state to the second state by positioning actuating assembly 910 within a chamber or other space having a width approximately similar or identical to the second width of body region 970, such that priming arm 972 is deflected inwardly by the chamber from the first position to the second position, thereby driving body region 970 apart and transitioning actuating assembly 910 from the first state to the second state.

[0070] In some embodiments, one or more of the body regions 970 include one or more priming surfaces 974 (individually identified in the illustrated embodiment as a first priming surface 974a and a second priming surface 974b of the first body region 970a, and a third priming surface 974c and a fourth priming surface 974d of the second body region 970b). One or more of the priming surfaces 974 can be configured to improve movement of the priming arms 972 and / or body region 970 relative to one another and / or to improve strain distribution across one or more portions of the actuation assembly 910 (e.g., one or both of body regions 970a and 970b). 9B, for example, first priming arm 972a contacts first priming surface 974a and third priming surface 974c when priming arm 972a is in the second position and / or actuation assembly 910 is in the second state. First priming surface 974a and third priming surface 974c may be angled or tilted inwardly (e.g., toward actuator 912) such that contact between first priming arm 972a and first priming surface 974a and third priming surface 974c may drive body regions 970a and 970b away from one another and deform actuation element 918 relative to their preferred geometry. Additionally or alternatively, contact between first priming arm 972a and first priming surface 974a and third priming surface 974c can at least partially inhibit or prevent body region 970a and body region 970b from moving toward one another. Thus, one or more of priming surfaces 974 can reduce, minimize, and / or prevent “kickback” or other movement induced by distortion / deformation of actuation assembly 910 after actuation assembly 910 is transitioned toward / to the second state ( FIG. 9B ).For example, moving the priming arms 972 inwardly toward their respective priming surfaces 974 can increase the rigidity of the actuation assembly 910, thereby at least partially inhibiting or preventing the actuation assembly 910 from moving toward / back to the first state (FIG. 9A) from the second state (FIG. 9B). Thus, in some aspects of the present technology, the priming frame 971 and / or actuation assembly 910 can be stable or otherwise generally resistant to undesired movement in both the first and second states (e.g., bi-stable), which is expected to further inhibit or prevent the actuation elements 818 from returning to their preferred geometry unless / until actuated via energy. In these and other embodiments, one or more priming surfaces 974 can be configured to not be contacted by the priming arms 972. In the illustrated embodiment, for example, the second priming arm 972b is spaced from (e.g., does not contact) the second priming surface 974b and the fourth priming surface 974d when the actuation assembly 910 is in the first and second states.

[0071] As will be appreciated by those skilled in the art, any of the actuation assemblies and / or actuators described above may be used with system 100 and / or another suitable adjustable shunt system to control the flow of fluid therethrough. Furthermore, particular features described with respect to one actuation assembly and / or actuator may be added to or combined with another actuation assembly and / or actuator. Thus, the technology is not limited to the actuation assemblies and / or actuators expressly identified herein.

[0072] The present technology may provide additional advantages beyond those explicitly described herein, for example, the present technology may provide improved surface quality of the actuation assembly and / or shunt system, better mechanical properties of the actuation assembly and / or shunt system, and / or may provide a wider range of materials to be used to manufacture the actuation assembly and / or shunt system. EXAMPLES

[0073] Several aspects of the present technology are described in the following examples. 1. An actuation assembly for controlling fluid flow through an adjustable shunt, the actuation assembly comprising: A first shape memory actuation element; and A second shape memory actuation element; and a body region positioned between and separating the first and second shape memory actuating elements, the body region having a lower thermal conductivity than the first and second shape memory actuating elements; a control element operably coupled to the first shape memory actuation element and the second shape memory actuation element; An actuation assembly, wherein (i) the first shape memory actuation element and the second shape memory actuation element are independently actuatable via heat, (ii) when actuated, the first shape memory actuation element is configured to move the control element toward a first position so as not to substantially interfere with fluid flow through an opening of the adjustable shunt, and (iii) when actuated, the second shape memory actuation element is configured to move the control element toward a second position so as to at least partially cover the opening. 2. The actuation assembly of example 1, wherein the body region is configured to thermally isolate the first actuation element from the second actuation element. 3. The actuation assembly of example 1 or example 2, wherein the body region has a first mass, the first actuation element and the second actuation element each have a second mass, and the first mass is greater than the second mass. 4. The actuation assembly of any of Examples 1-3, wherein the first shape memory element and the second shape memory element are arranged in a stacked configuration along a common axis parallel to the central axis of the opening. 5. An actuation assembly as described in any of Examples 1-4, wherein the control element is configured to move between the first position and the second position in a plane parallel to a central axis extending through the opening. 6. An actuation assembly described in any of Examples 1 to 5, wherein the control element is one of a plurality of control elements, the first shape memory actuation element and the second shape memory actuation element are a first pair of a plurality of pairs of the first shape memory actuation element and the second actuation element, and the body region is one of a plurality of body regions. 7. The actuation assembly of example 6, wherein the multiple body regions are formed by a single, integral structure. 8. An actuation assembly for use with a shunt system, the actuation assembly comprising: a first sheet including one or more first actuation elements; a second sheet including one or more second actuation elements; and a third sheet including one or more actuator bodies, each of the one or more actuator bodies having an end region; and an actuator mount including one or more ports configured to correspond to and receive an end region of a corresponding one or more actuator bodies; each of the first sheet, the second sheet, the third sheet, and the actuator mount configured to be combined in a predetermined configuration; An actuation assembly, wherein combining the first sheet, the second sheet, the third sheet, and the actuator mount in a predetermined configuration causes at least one of the one or more first actuation elements and the second actuation elements to deform relative to their manufactured geometric shapes. 9. each of the one or more actuator bodies includes a control element positioned on an opposite end region; a third sheet positioned between the control element and the end region, the third sheet further including an actuator body support coupling each of the one or more actuator bodies; the one or more first actuating elements and the second actuating element have a first length; the actuator body having a second length between the control element and the actuator body support; 9. The actuation assembly of example 8, wherein the first length is greater than the second length. 10. An actuation assembly as described in example 8 or 9, wherein each of the one or more ports is configured to correspond to and receive one of the end regions of the one or more actuator bodies. 11. An actuation assembly as described in Example 8 or 9, wherein at least one of the one or more ports is configured to correspond to and receive two or more of the end regions of the one or more actuator bodies. 12. An actuation assembly described in any of Examples 8 to 11, wherein combining the first sheet, the second sheet, the third sheet, and the actuator mount in a predetermined configuration automatically deforms at least one of the one or more first actuation elements and the second actuation elements. 13. An actuation assembly described in any of Examples 8-12, wherein combining the first sheet, the second sheet, the third sheet, and the actuator mount in a predetermined configuration simultaneously deforms each of one or more of the first actuation elements and the second actuation elements. 14. An actuation assembly for use with a shunt system, the actuation assembly comprising: a fluid inlet configured to be fluidly coupled to an environment external to the shunt system; a first actuating element having a first target configured to (i) receive energy from an external energy source and (ii) dissipate the received energy to the first actuating element to drive actuation thereof, the first actuating element being further configured, upon actuation, to move the first target towards and / or to the fluid inlet to increase fluid resistance at the fluid inlet; a second actuation element configured, upon actuation, to move the first target away from the fluid inlet to reduce fluid resistance at the fluid inlet. 15. The actuation assembly of example 14, wherein the first target is configured to form a fluid seal with the fluid inlet when the first actuation element moves the first target toward the fluid inlet. 16. The actuation assembly of any one of examples 14 and 15, wherein the fluid inlet is configured to at least partially deform when the first actuation element moves the first target toward the fluid inlet. 17. An actuation assembly described in any of Examples 14-16, wherein the fluid inlet includes a wall, and the wall is configured to at least partially deform when the first actuation element moves the first target toward the fluid inlet. 18. an actuator body having a flared end portion, a first actuating element and a second actuating element coupled to the actuator body; a first receiving chamber configured to receive the flared end portion and maintain the first and second actuating elements in the first configuration; The actuation assembly of any of Examples 14 to 17, further comprising a second receiving chamber configured to receive the flared end portion and deform the first actuation element and the second actuation element relative to the first configuration. 19. A method of manufacturing an actuation assembly, the method comprising: forming a first sheet from a first material, the first sheet including a plurality of first actuation elements; forming a second sheet from the first material, the second sheet including a plurality of second actuation elements; forming a third sheet from a second material, the third sheet including a plurality of actuator bodies; forming an actuator mount from a third material; and combining the first sheet, the second sheet, the third sheet, and the actuator mount in a predetermined configuration to form a plurality of actuators; The method, wherein combining the first sheet, the second sheet, the third sheet, and the actuator mount in a predetermined configuration includes deforming a plurality of first actuating elements and a plurality of second actuating elements to a preferred geometry. 20. A system for selectively controlling fluid flow within a patient, the system comprising: a drainage element having a channel therethrough and a port in fluid communication with the channel; and an actuation assembly coupled to the drainage element and configured to control fluid flow through the port, the actuation assembly comprising: a base plate including a fluid inlet; an actuator mount coupled to the actuation assembly; an actuator body having a first end region coupled to the actuator mount and a second end region opposite the first end region and including a control element, the control element being aligned with the fluid inlet; a first actuation element coupled to the control element, the first actuation element configured, upon actuation, to pivot the actuator body to move the control element in a first direction toward the fluid inlet; a second actuating element coupled to the control element, the second actuating element configured, upon actuation, to pivot the actuator body to move the control element in a second direction away from the fluid inlet. 21. The system of example 20, wherein the first and second actuating elements are constructed from Nitinol. 22. The system of embodiment 20 or 21, further comprising a sealing element positioned between the control element and the fluid inlet. twenty three. the first actuation element includes a first target extending in a first direction from the first actuation element, the first target configured to receive an input to actuate the first actuation element; the second actuation element includes a second target extending in a second direction from the second actuation element, the second target configured to receive an input to actuate the second actuation element; 23. The system of any of Examples 20-22, wherein the second direction is different from the first direction. 24. A method of manufacturing an actuation assembly, the method comprising: Molding one or more actuators into a first configuration, wherein in the first configuration: each individual actuator of the one or more actuators is positioned within a corresponding well, each corresponding well including a first chamber and a second chamber; molding, each individual actuator of the one or more actuators including a first actuating element, a second actuating element, and an actuator body, the actuator body having a distal end portion residing within the first chamber or the second chamber; moving one or more of the actuators from a first configuration to a second, different configuration in which a distal end portion of the actuator body is in the other of the first chamber or the second chamber; A method, wherein moving one or more actuators from a first configuration to a second configuration deforms a first actuating element and / or a second actuating element relative to a preferred geometry. twenty five. When the one or more actuators are in a first configuration, the distal end portion is positioned within the first chamber; Moving the one or more actuators from the first configuration to the second configuration further includes moving the distal end portion from the first chamber to the second chamber; 25. The method of example 24, wherein deforming the first actuating element and / or the second actuating element comprises compressing the first actuating element and / or the second actuating element to a preferred geometry. 26. When the one or more actuators are in the first configuration, the distal end portion is positioned within the second chamber; Moving the one or more actuators from the first configuration to the second configuration further includes moving the distal end portion from the second chamber to the first chamber; 25. The method of example 24, wherein deforming the first and second actuating elements includes stretching the first and / or second actuating elements to a preferred geometry. 27. An actuation assembly for use with a shunt system for selectively controlling fluid flow within a patient, comprising: A fluid inlet; and an actuator configured to selectively control the flow of fluid through the fluid inlet, the actuator comprising: A first body portion; a second body portion including a control element configured to sealingly engage the fluid inlet; an actuation element positioned between the first body portion and the second body portion; an actuation assembly, the actuation element being configured to transition the control element between (i) a first position in which the control element sealingly engages the fluid inlet and (ii) a second position in which the control element is spaced from the fluid inlet to allow fluid to flow therethrough. 28. The actuation assembly of example 27, wherein the second body portion further includes a pivot feature, and the actuation element is configured to transition the control element between the first position and the second position by rotating the control element about the pivot feature. 29. The actuation assembly of claim 28, wherein the actuation element is configured to transition the control element between the first position and the second position by rotating the control element about the pivot feature. 30. The actuation assembly of example 28 or example 29, wherein the second body portion further includes a control element portion, and the control element extends from the control element portion toward the fluid inlet. 31. The actuation assembly of example 30, wherein the actuation element is configured to transition the control element between the first position and the second position by pivoting the control element portion about the pivot feature. 32. a chamber including a first chamber portion and a second chamber portion; a first body portion configured to be received within the first chamber; a second body portion configured to be received within the second chamber; the actuation element is a shape memory actuator having a preferred geometry; The actuation assembly of any of Examples 27-31, wherein the shape memory actuator is deformed to a preferred geometric shape when the first body portion is received in the first chamber and the second body portion is received in the second chamber. 33. The actuation assembly of any of examples 27-32, wherein in the first position, at least a portion of the control element is positioned within the fluid inlet. 34. The actuation assembly of any of examples 27-33, wherein the actuation element is further configured to transition the control element to a third position between the first position and the second position. 35. The inlet is a first inlet, the control element is a first control element, and the actuation assembly is a second fluid inlet; the second body portion further includes a second control element configured to sealingly engage the second fluid inlet; In the first position, the first control element is in sealing engagement with the first fluid inlet and the second control element is spaced from the second fluid inlet to permit fluid flow therethrough; An actuation assembly described in any of Examples 27 to 34, wherein in the second position, the second control element sealingly engages the second fluid inlet and the first control element is spaced from the first fluid inlet to allow fluid to flow therethrough. 36. An actuation assembly described in any of Examples 27-34, further comprising a sealing element positioned between the control element and the fluid inlet and configured to sealingly engage the fluid inlet when the control element is in the first position. 37. An actuation assembly for use with an adjustable shunt system for selectively controlling fluid flow within a patient, the actuation assembly comprising: a first body region; a second body region; an actuator extending between the first body region and the second body region, the actuator including a shape memory actuation element having an original geometric shape; a pair of priming arms extending between the first body region and the second body region; An actuation assembly, the first body region, the second body region, and the pair of priming arms defining a priming frame configured to deform the shape memory actuation element relative to an original geometric shape. 38. The actuation assembly of example 37, wherein the pair of priming arms includes a first priming arm positioned on a first side of the actuator and a second priming arm positioned on a second side of the actuator opposite the first priming arm. 39. An actuation assembly as described in Example 37 or Example 38, wherein each priming arm of a pair of priming arms is configured to bend inwardly toward the actuator, driving the first body region away from the second body region and deforming the shape memory actuation element relative to its original geometric shape. 40. An actuation assembly described in any of Examples 37-39, wherein an individual priming arm of a pair of priming arms is configured to cause movement of the first body region relative to the second body region to transition the priming frame between a first state in which the shape memory actuation element has an original geometric shape and a second state in which the shape memory actuation element is deformed relative to the original geometric shape. 41. The actuation assembly of example 40, wherein each priming arm of the pair of priming arms is configured to at least partially prevent the priming frame from moving back from the second state toward the first state. 42. An actuation assembly as described in Example 40 or Example 41, wherein when the priming frame is in the second state, each priming arm of a pair of priming arms is configured to at least partially prevent the first body region and the second body region from moving toward each other. 43. In a first state, each of the pair of priming arms has a first position; 43. The actuation assembly of any one of Examples 40 to 42, wherein in the second state, each of the pair of priming arms has a second position deflected relative to the first position. 44. An actuation assembly for controlling fluid flow through an adjustable shunt, the actuation assembly comprising: A first shape memory actuation element; and A second shape memory actuation element; and a control element operably coupled to the first shape memory actuation element and the second shape memory actuation element; a sealing element configured to sealingly engage the opening of the adjustable shunt; 1. An actuation assembly, wherein (i) the first shape memory actuation element and the second shape memory actuation element are independently actuatable via heat; (ii) upon actuation, the first shape memory actuation element is configured to move the control element toward a first position such that it does not substantially interfere with fluid flow through the opening, and in the first position, the sealing element is spaced from the opening to allow fluid to at least partially flow therethrough; and (iii) upon actuation, the second shape memory actuation element is configured to move the control element toward a second position such that the sealing element at least partially obstructs fluid flow through the opening. 45. The actuation assembly of example 44, wherein in the second position, the control element is configured to press the sealing element against the opening to form a substantially fluid-tight seal thereat. 46. ​​The actuation assembly of example 44 or example 45, wherein in the first position, the control element is spaced from the sealing element and the fluid opening. 47. An actuation assembly described in any of Examples 44 to 46, further comprising an actuator body positioned between the first shape memory actuation element and the second shape memory actuation element, and configured such that, upon actuation, the first shape memory actuation element and the second shape memory actuation element pivot the actuator body to move the control element between the first position and the second position. 48. The actuation assembly of any of examples 44-47, wherein the sealing element comprises an elastomeric material. 49. The actuation assembly of any of examples 44-48, wherein the sealing element comprises at least one of silicone, PDMS, or PMMA. 50. An actuation assembly described in any of examples 44-49, wherein the control element is configured to move between a first position and a second position in a plane parallel to a central axis extending through the opening and the sealing element.

[0074] conclusion The above detailed description of the embodiments of the present technology is not intended to be exhaustive or to limit the present technology to the precise forms disclosed above. Although specific embodiments and examples of the present technology are described above for illustrative purposes, those skilled in the art will recognize that various equivalent modifications are possible within the scope of the present technology. For example, any of the features of the intraocular shunt described herein can be combined with any of the features of the other intraocular shunt described herein, and vice versa. Furthermore, although steps are presented in a given order, in alternative embodiments, steps may be performed in a different order. Various embodiments described herein may also be combined to provide further embodiments.

[0075] From the foregoing, it will be understood that, while specific embodiments of the present technology have been described herein for purposes of illustration, well-known structures and functions associated with intraocular 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 also include the plural or singular terms, respectively.

[0076] Unless the context clearly dictates otherwise, throughout the description and examples, words such as "comprise", "comprising", and the like, are to be construed in an inclusive sense, i.e., "including, but not limited to", and not in an exclusive or exhaustive sense. As used herein, the terms "connected", "coupled", or any variation thereof, refer to any direct or indirect connection or coupling between two or more elements. The coupling of connections between elements may be physical, logical, or a combination thereof. Additionally, the words "herein", "above", "below", and words of similar import, when used in this application, refer to this application as a whole and not to any particular portions of this application. Where the context permits, words in the above detailed description using the singular or plural may each be in the plural or singular. As used herein, the phrase "and / or" appearing in "A and / or B" may refer to A only, B only, or both A and B. Additionally, the term "comprising" is used throughout to mean including at least the recited features, without excluding any more of the same features and / or other features of additional types. It will also be understood that, although certain embodiments have been described herein for purposes of illustration, various modifications may be made without departing from the technology. Furthermore, although advantages associated with some embodiments of the technology have been described in the context of these embodiments, other embodiments may also exhibit such advantages, and not all embodiments necessarily exhibit such advantages to fall within the scope of the technology. Thus, the present disclosure and related technology may encompass other embodiments not explicitly shown or described herein.

Claims

**Claim 1** An actuation assembly for use with a shunt system for selectively controlling fluid flow within a patient, said actuation assembly comprising: a fluid inlet; an actuator configured to selectively control the flow of said fluid through said fluid inlet; and said actuator comprising: a first body portion; a second body portion including a control element configured to sealingly engage said fluid inlet; and an actuating element positioned between said first body portion and said second body portion; wherein said actuating element is configured to move said control element between (i) a first position in which said control element sealingly engages said fluid inlet and (ii) a second position in which said control element is spaced from said fluid inlet to permit fluid to flow therethrough, an actuation assembly. **Claim 2** The actuation assembly of claim 1, wherein said second body portion further includes a pivotal feature, and said actuating element is configured to move said control element between said first position and said second position by moving said control element around said pivotal feature. **Claim 3** The actuation assembly of claim 2, wherein said actuating element is configured to move said control element between said first position and said second position by rotating said control element around said pivotal feature. **Claim 4** The actuation assembly of claim 2, wherein said second body portion further includes a control element portion, and said control element extends from said control element portion toward said fluid inlet. **Claim 5** The actuation assembly of claim 4, wherein said actuating element is configured to move said control element between said first position and said second position by pivoting said control element portion around said pivotal feature. **Claim 6** further comprising a chamber including a first chamber portion and a second chamber portion, wherein said first body portion is configured to be received within said first chamber, said second body portion is configured to be received within said second chamber, and said actuating element is a shape memory actuator having a preferred geometry. The operating assembly according to claim 1, wherein when the first body portion is received in the first chamber and the second body portion is received in the second chamber, the shape memory actuator is deformed with respect to the preferred geometry.

7. The operating assembly according to claim 1, wherein at the first position, at least a portion of the control element is positioned within the fluid inlet.

8. The operating assembly according to claim 1, wherein the actuating element is further configured to move the control element to a third position between the first position and the second position.

9. The inlet is a first inlet, the control element is a first control element, the operating assembly further comprises a second fluid inlet, the second body portion further includes a second control element configured to sealingly engage the second fluid inlet, at the first position, the first control element sealingly engages the first fluid inlet and the second control element is spaced from the second fluid inlet to allow fluid to flow therethrough, The operating assembly according to claim 1, wherein at the second position, the second control element sealingly engages the second fluid inlet and the first control element is spaced from the first fluid inlet to allow fluid to flow therethrough.

10. The operating assembly according to claim 1, further comprising a sealing element positioned between the control element and the fluid inlet and configured to sealingly engage the fluid inlet when the control element is in the first position.

11. A method of manufacturing an operating assembly, the method comprising: forming one or more actuators into a first configuration, wherein in the first configuration, each individual actuator of the one or more actuators is positioned within a corresponding well, and each corresponding well includes a first chamber and a second chamber, each individual actuator of the one or more actuators includes a first actuating element, a second actuating element, and an actuator body, the actuator body having a distal end portion present within the first chamber or the second chamber. moving one or more of the actuators from the first configuration to a second, different configuration in which the distal end portion of the actuator body is in the other of the first chamber or the second chamber comprising a method of moving the one or more actuators from the first configuration to the second configuration, the method deforming the first actuating element and / or the second actuating element into a preferred geometry **Claim 12** when the one or more actuators are in the first configuration, the distal end portion is positioned within the first chamber moving the one or more actuators from the first configuration to the second configuration further comprises moving the distal end portion from the first chamber to the second chamber deforming the first actuating element and / or the second actuating element comprises compressing the first actuating element and / or the second actuating element into the preferred geometry, the method of claim 11 **Claim 13** when the one or more actuators are in the first configuration, the distal end portion is positioned within the second chamber moving the one or more actuators from the first configuration to the second configuration further comprises moving the distal end portion from the second chamber to the first chamber deforming the first actuating element and the second actuating element comprises elongating the first actuating element and / or the second actuating element into the preferred geometry, the method of claim 11 **Claim 14** an actuation assembly for use with an adjustable shunt system for selectively controlling fluid flow within a patient, the actuation assembly comprising a first body region a second body region an actuator extending between the first body region and the second body region, the actuator comprising a shape memory actuating element having an original geometry a pair of priming arms extending between the first body region and the second body region comprising an actuation assembly, wherein the first body region, the second body region, and the pair of priming arms define a priming frame configured to deform the shape memory actuating element into the original geometry **Claim 15** The pair of priming arms includes a first priming arm positioned on a first side of the actuator and a second priming arm positioned on a second side of the actuator opposite the first priming arm, the actuating assembly according to claim 14.

16. Each of the pair of priming arms is configured to bend inwardly toward the actuator, drive the first body region away from the second body region, and deform the shape memory actuating element relative to the original geometry, the actuating assembly according to claim 14.

17. Each of the pair of priming arms is configured to cause movement of the first body region relative to the second body region to transition the priming frame between a first state in which the shape memory actuating element has the original geometry and a second state in which the shape memory actuating element is deformed relative to the original geometry, the actuating assembly according to claim 14.

18. Each of the pair of priming arms is configured to at least partially prevent the priming frame from returning from the second state toward the first state, the actuating assembly according to claim 17.

19. When the priming frame is in the second state, each of the pair of priming arms is configured to at least partially prevent the first body region and the second body region from moving toward each other, the actuating assembly according to claim 17.

20. In the first state, each of the pair of priming arms has a first position, In the second state, each of the pair of priming arms has a second position bent relative to the first position, the actuating assembly of claim 17.

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