WO2024030949A1 - Systèmes de dérivation réglables comprenant des ensembles d'actionnement, et dispositifs et procédés associés - Google Patents

Systèmes de dérivation réglables comprenant des ensembles d'actionnement, et dispositifs et procédés associés Download PDF

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Publication number
WO2024030949A1
WO2024030949A1 PCT/US2023/071501 US2023071501W WO2024030949A1 WO 2024030949 A1 WO2024030949 A1 WO 2024030949A1 US 2023071501 W US2023071501 W US 2023071501W WO 2024030949 A1 WO2024030949 A1 WO 2024030949A1
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WIPO (PCT)
Prior art keywords
actuator
actuation
state
priming
actuation assembly
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Application number
PCT/US2023/071501
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English (en)
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WO2024030949A9 (fr
Inventor
Tessa Bronez
David Batten
Tom Saul
Eric Schultz
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Shifamed Holdings, Llc
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Application filed by Shifamed Holdings, Llc filed Critical Shifamed Holdings, Llc
Publication of WO2024030949A1 publication Critical patent/WO2024030949A1/fr
Publication of WO2024030949A9 publication Critical patent/WO2024030949A9/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
    • A61M27/002—Implant devices for drainage of body fluids from one part of the body to another
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/00781—Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment

Definitions

  • the present technology generally relates to implantable medical devices and, in particular, to adjustable shunting systems and associated methods for selectively controlling fluid flow between a first body region and a second body region of a patient.
  • Implantable shunting systems are widely used to treat a variety of patient conditions by shunting fluid from a first body region/cavity to a second body region/cavity.
  • shunting systems have been proposed for treating glaucoma
  • the flow of fluid through the shunting systems 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).
  • MIGS minimally invasive glaucoma surgery devices
  • FIG. 1A is a partially schematic top view of an adjustable shunting system configured in accordance with embodiments of the present technology.
  • FIG. IB is a partially schematic top view of select aspects of the adjustable shunting system of FIG. 1A with other aspects omitted for the purposes of illustration.
  • FIG. 1C is a top view of an actuation assembly of the adjustable shunting system of FIG. 1A in a folded state.
  • FIG. ID is a perspective view of the actuation assembly of FIG. 1C in an unfolded state.
  • FIG. 2 is a perspective view of another actuation assembly configured in accordance with embodiments of the present technology.
  • FIG. 3 is a perspective view of an additional actuation assembly configured in accordance with embodiments of the present technology.
  • FIG. 4A is a perspective view of yet another actuation assembly in an unfolded state and configured in accordance with embodiments of the present technology.
  • FIG. 4B is a perspective view of the actuation assembly of FIG. 4B in a folded state and positioned within a plate assembly in accordance with embodiments of the present technology.
  • FIG. 5A is a top view of another actuation assembly in an unfolded state and configured in accordance with embodiments of the present technology.
  • FIG. 5B is a perspective view of the actuation assembly of FIG. 5 A in a folded state in accordance with embodiments of the present technology.
  • FIG. 6 is a top view of yet another actuation assembly in an unfolded state and configured in accordance with embodiments of the present technology.
  • FIG. 7 is a top view of still another actuation assembly in an unfolded state and configured in accordance with embodiments of the present technology.
  • FIG. 8 is a top view of the actuation assembly of FIG. 7 in a folded state and positioned within a plate assembly in accordance with embodiments of the present technology.
  • an actuation assembly includes an actuator portion, a base portion, and a folding portion extending therebetween.
  • the actuation assembly can be transitioned between a first or unfolded state and a second or folded state in response to movement of the actuator portion relative to the base portion about the folding portion, and/or movement of the base portion relative to the actuator portion about the folding portion.
  • the actuator portion can be rotated or pivoted about the folding portion relative to the base portion to fold and/or otherwise transition the actuation assembly from the unfolded state to the folded state.
  • the actuation assembly can be configured to control the flow of fluid through an adjustable shunting system.
  • the base portion can include one or more actuator inlets configured to be aligned with and/or fluidly coupled to one or more channels of an adjustable shunting system.
  • the actuator portion can include one or more actuators, and individual ones of the actuators can be configured to selectively and/or independent control the flow of fluid through individual ones of the actuator inlets.
  • At least one of the actuators can include a gating element and a pair of actuation elements operably coupled to the gating element and configured to move the gating element between (i) a first position in which the gating element substantially allows fluid flow through one or more of the actuator inlets, and (ii) a second position in which the gating element substantially prevents fluid flow through one or more of the actuator inlet.
  • one or more of the actuation elements in the actuator portion can be shape-memory actuation elements having a preferred geometry.
  • the base portion can include one or more priming features configured to deform the shape-memory actuation elements relative to their preferred geometry, to thereby allow the shape-memory actuation elements to be actuated (e.g., by heat or non-destructive laser energy) to drive the movement of the gating element between the first position and the second position.
  • the shape-memory actuation elements can be deformed relative to their preferred geometries when the actuation assembly is transitioned between the unfolded state to the folded state.
  • individual ones of the priming features can be positioned to cause the actuation elements to be deformed or strained relative to their preferred geometries after the actuation assembly has been transitioned from the unfolded state to the folded state.
  • actuation assemblies configured in accordance with the present technology may exhibit one or more advantageous characteristics that improve operation of adjustable shunting systems.
  • At least some of the actuation assemblies described herein can be manufactured from a single sheet of material, which is expected to reduce or eliminate the variability in size and/or shape between individual aspects of the actuation assemblies, improve the tolerances and/or fit between the individual aspects of the actuation assemblies, and/or create a more consistent deformation/strain in the actuation elements when the actuation assembly is transitioned from the unfolded state to the folded state.
  • at least some of the actuation assemblies described herein can be at least partially resistant to deformation/folding of the base portion during the transition between an unfolded and folded state.
  • the systems described herein can be used to treat diseases characterized by increased pressure and/or fluid build-up, 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, and the like.
  • heart failure e.g., heart failure with preserved ejection fraction, heart failure with reduced ejection fraction, etc.
  • pulmonary failure pulmonary failure
  • renal failure e.g., pulmonary failure, renal failure, hydrocephalus, and the like.
  • the systems described herein may be applied equally to shunting other fluid, such as blood or cerebrospinal fluid, between the first body region and the second body region.
  • FIG. 1A is a partially schematic top view of an adjustable shunting system 100 (“the system 100”) configured in accordance with select embodiments of the present technology.
  • FIG. IB is a partially schematic top view of the system 100 with actuation assembly 130 (FIG. 1 A) omitted for purposes of illustration.
  • the system 100 is configured to provide an adjustable therapy for draining fluid from a first body region to a second, different body region, such as to drain aqueous from an anterior chamber of a patient’s eye.
  • the system 100 includes a generally elongated housing 102 and a plate assembly 120.
  • the elongated housing 102 (which can also be referred to as a casing, membrane, shunting element, or the like) extends between a first end portion 102a and a second end portion 102b.
  • the elongated housing 102 can further include a main fluid conduit 1 10 fluidly coupling the plate assembly 120 to one or more outlets 106 positioned proximate the second end portion 102b of the elongated housing 102.
  • the elongated housing 102 is composed of a slightly elastic or flexible biocompatible material (e.g., silicone, etc.).
  • the elongated housing 102 can also optionally have one or more wings or appendages 108 for securing the elongated housing 102 in a desired position within a patient.
  • the plate assembly 120 (which can also be referred to as a flow control plate, a flow control cartridge, a plate structure, or the like) is positioned within the elongated housing 102 and is configured to selectively control the flow of fluid through the system 100.
  • the plate assembly 120 can at least partially define one or more fluid paths through the system 100.
  • the plate assembly 120 is positioned with an interior chamber 121 of the housing 102 that is fluidly coupled to an environment external to the system 100 by one or more inlets 104. Accordingly, individual ones of the inlets 104 can permit fluid to flow into the chamber 121 of the plate assembly 120, and thus an interior of the elongated housing 102, from an environment external to the system 100.
  • an outer surface of the plate assembly 120 forms a substantial fluid seal with an inner surface of the elongated housing 102, such that fluid flowing into the system 100 via the inlets 104 generally must pass through the plate assembly 120.
  • fluid can flow out of the chamber 121 via one or more channels 122 (individually identified as a first channel 122a, a second channel 122b, and a third channel 122c in FIG. 1A) extending between the chamber 121 and the mam fluid conduit 110.
  • Each of the channels 122 can be fluidly isolated such that each of the channels 122 can define a discrete flow path through the plate assembly 120.
  • the system 100 includes three channels 122a-c, each of which is fluidly coupled to a respective channel inlet 124 (individually identified as a first channel inlet 124a, a second channel inlet 124b, and a third channel inlet 124c in FIG. IB).
  • each of the channels 122a-b can include a respective channel outlet 126 (individually identified as a first channel outlet 126a, a second channel outlet 126b, and a third channel outlet 126c in FIGS. 1A and IB) fluidly coupled to the main fluid conduit 110.
  • Fluid that enters the plate assembly 120 via the one or more inlets 104 can drain to the main fluid conduit 110 by entering at least one of the channel inlets 124a-c, flowing through the corresponding channel 122a-c, and into the main fluid conduit 110 via the corresponding channel outlet 126a-c.
  • each of the channels 122 and/or respective portions thereof can have different geometric configurations and/or dimensions (e.g., lengths, widths, diameters, cross-sectional areas, etc.) relative to one another.
  • each of the channels 122 can have different fluid resistances, and thus provide different flow rates for a given pressure.
  • the first channel 122a has a first length corresponding to a first fluid resistance
  • the second channel 122b has a second length less than the first length and corresponding to a second fluid resistance less than the first fluid resistance
  • the third channel 122c has a third length less than the second length and corresponding to a third fluid resistance less than the second fluid resistance.
  • individual ones of the channels 122 can have a same length but different cross-sectional areas.
  • the channels 122 can have other suitable configurations relative to each other.
  • the relative level of therapy provided by each fluid path through the system 100 e.g., the channels 122
  • the system 100 can provide a first drainage rate, and when fluid primarily drains through the second channel 122b, the system 100 can provide a second drainage rate greater than the first drainage rate.
  • the plate assembly 120 further includes an actuation assembly 130 positioned in the chamber 121 and including one or more actuators 132 (individually identified as a first actuator 132a and a second actuator 132b in FIG. 1A) configured to control the flow of fluid through one or more the channels 122/channel inlets 124.
  • the first actuator 132a is configured to control the flow of fluid through the first channel 122a and/or the first channel mlet 124a
  • the second actuator 132b is configured to control the flow of fluid through the second channel 122b and/or the second channel inlet 124b.
  • the actuation assembly 130 can further include one or more ports or actuator inlets 134 (individually identified as a first actuator inlet 134a, a second actuator inlet 134b, and a third actuator inlet 134c in FIG. 1A).
  • Each of the actuator inlets 134 can be aligned with (e.g., positioned above) and/or fluidly coupled to one or more of the channel inlets 124 (FIG. IB).
  • the first actuator inlet 134a (FIG. 1 A) is fluidly coupled to the first channel inlet 124a (FIG. IB)
  • the second actuator inlet 134b (FIG. 1A) is fluidly coupled to the second channel inlet 124b (FIG.
  • the third actuator inlet 134c (FIG. 1A) is fluidly coupled to the third channel inlet 124c (FIG. IB). Accordingly, fluid can flow through individual ones of the actuator inlets 134, enter the associated channel inlet 124, pass through the corresponding channel 122, and flow out of the system 100 via the one or more outlets 106.
  • the actuation assembly 130 is in a folded state 131a, which can also be referred to as a “second state,” an “operating state,” a “primed stated,” a “subsequent state,” a “changed state,” a “deformed state,” a “strained state,” and/or the like. As described in greater detail below with reference to FIGS.
  • the actuation assembly 130 is configured to be transformed (e.g., folded) to the folded state 131a from an unfolded state 131b, which can also be referred to as a “first state,” an “original state,” an “as -manufactured state,” a “pre-primed” state, an “initial state,” an “unstrained state,” and/or the like (FIG. ID).
  • flow through one or more of the channels 122 can be independent of the actuators 132 and/or actuation assembly 130.
  • the actuators 132a-b do not substantially prevent or control flow through the third actuator inlet 134c, such that flow through the third channel 122c is expected to be at least generally independent of the actuators 132a-b and/or the actuation assembly 130.
  • the third channel 122c can be configured to provide a passive, minimum, or baseline drainage/flow rate through the system 100, which can be increased by allowing flow through at least one of first channel 122a and/or the second channel 122b.
  • the system 100 and/or the plate assembly 120 can be configured to operate in reverse.
  • fluid can enter the system 100 via the one or more outlets 106
  • the actuation assembly 130 can control the flow of fluid from the channels 122 into the chamber 121
  • fluid can drain from the plate assembly 120 via one or more of the inlets 104. Additional details regarding the operation of shape memory actuators suitable for use with the present technology, as well as adjustable glaucoma shunts, are described in U.S. Patent Nos. 11,058,581; 11,166,849; and 11,291,585; and International Patent Application Nos.
  • PCT/US22/13336 PCT/US20/55144; PCT/US20/55141; PCT/US21/14774; PCT/US21/18601; PCT/US21/23238; PCT/US21/27742; PCT/US21/49140; and
  • the system 100 illustrated in FIGS. 1A and IB comprises one inlet 104 and one chamber 121
  • the system 100 can include additional openings and/or chambers.
  • the plate assembly 120 can include at least two, three, four, or any other suitable number of fluid inlets and/or chambers.
  • the plate assembly 120 shown in FIGS. 1A and IB has three channels 122a-c, in other embodiments the plate assembly 120 can include more or fewer channels.
  • the plate assembly 120 can include at least one, two, four, five, or any other suitable number of channels 122.
  • the number of actuators 132 can equal to the number of channels 122, or be at least one, two, three, or more less than the number of channels 122. In these and other embodiments, each actuator 132 may control the flow of fluid through two or more of the channels 122. Additionally, or alternatively, individual ones of the actuators 132 can be configured/positioned to control fluid flow into the chamber 121, e.g., via one or more of the inlets 104.
  • FIG. 1C is a top view of the actuation assembly 130 of FIG. 1A.
  • the actuation assembly 130 includes two actuators 132 (identified individual as first actuator 132a and second actuator 132b). In other embodiments, however, the actuation assembly 130 can include at least one, three, four, or another suitable number of actuators 132.
  • individual ones of the actuators 132 can include one or more aspects that are generally similar or identical in structure and/or function to one or more aspects of individual ones of the actuators described in International Patent Application No. PCT/US23/71106, previously incorporated by reference herein.
  • each of the actuators 132 can include a gating element 136 (individually identified as a first gating element 136a of the first actuator 132a and a second gating element 136b of the second actuator 132b in FIG. 1C) and one or more actuation elements 138 (individually identified as first actuation elements 138a and second actuation elements 138b in FIG. 1C).
  • Each of the gating elements 136 can be positioned to selectively control the flow of fluid through one or more of the actuator inlets 134. For example, in the illustrated embodiment and as shown in FIGS.
  • the first gating element 136a is positioned above the first actuator inlet 134a and/or to control the flow of fluid through the first channel 122a (FIGS. 1 A and IB), and the second gating element 136b is positioned above the second actuator inlet 134b and/or to control the flow of fluid through the second channel 122b (FIGS. 1 A and IB). Additionally, each of the gating elements 136 can be configured to moveably interface with the corresponding actuator inlet 134.
  • the first actuator 132a can be configured to move between at least (i) a first position or state in which the first gating element 136a permits fluid to flow through the first actuator inlet 134a (e.g., by not interfering with or blocking the first actuator inlet 134a), and (ii) a second position or state in which the first gating element 136a substantially prevents fluid from flowing through the first actuator inlet 134a (e.g., by blocking, covering, or sealing the first actuator inlet 134a).
  • the second actuator 132b can be configured to move between at least (i) a first position or state in which the second gating element 136b permits fluid to flow through the second actuator inlet 134b, and (ii) a second position or state in which the second gating element 136b substantially prevents fluid from flowing through the second actuator inlet 134b.
  • one or more of the gating elements 136 can be configured to be moved to one or more intermediate positions between the first and the second position (e.g., a third position, a fourth position, etc.) in which the corresponding actuator inlet 134 is unblocked, partially blocked/unblocked (e.g., as shown in FIG. 1C), or fully blocked.
  • Each of the gating elements 136 can be selectively and/or independently transitioned between the first and second positions by rotating, pivoting, or otherwise moving the gating elements 136 about respective rotation or pivot features 140 (individually identified as a first pivot feature 140a and a second pivot feature 140b in FIG. 1C).
  • the actuation assembly 130 can include one or more first priming surfaces or features 142 (individually identified as first priming features 142a-b in FIG. 1C), and one or more of the gating elements 136 can include a recess 137 (individually identified as a first recess 137a and a second recess 137b in FIG.
  • first priming features 142a-b each include an apex or pivot point about which the corresponding gating elements 136a-b can be rotated, pivoted, or otherwise moved between the first and second positions.
  • one or more of the gating elements 136 can include a spherical component or portion, such as a bead or a ball-shaped element, configured to be at least partially aligned with one or both of the first and second actuator inlets 134a-b.
  • the spherical component or portion can be configured to sealingly engage or plug the first and/or second channel inlets 135a-b, for example, when aligned with the respective first and/or second actuator inlets 134a-b.
  • one or both of the gating elements 136a-b include a spherical portion having a curved or arcuate lower surface shaped to correspond to and/or configured to be at least partially received within one or both of the first and/or second actuator inlets 134a-b, such that the curved or arcuate lower surface sealingly engages one or both of the first and/or second actuator inlets 134a-b.
  • one or both of the gating elements 136a-b can include silicone and/or one or more other aspects that are generally similar or identical to at least one of the gating elements described in International Patent Application No.
  • individual ones of the gating elements 136 can include any other suitable material(s) and/or combination(s) thereof.
  • gating elements with spherical portions and/or that include silicone can have improved sealing engagement with the actuator inlets 134a-b, for example, to partially or fully prevent fluid from leaking into the channels 122 (FIGS. 1A and IB) when the gating elements 136 engage the corresponding actuator inlets 134.
  • the actuation elements 138 can drive movement of the gating elements 136 between the first position, the second position, and/or any other position to which individual ones of the gating elements 136 are configured to transition.
  • the actuation elements 138 can be composed at least partially of a shape memory material or alloy (e.g., Nitinol).
  • the actuation elements 138 can be transitionable at least between a first material phase or state (e.g., a martensitic state, a R-phase, a composite state between martensitic and R-phase, etc.) and a second material phase or state (e.g., an austenitic state, an R-phase state, a composite state between austenitic and R-phase, etc.).
  • a first material phase or state e.g., a martensitic state, a R-phase, a composite state between martensitic and R-phase, etc.
  • a second material phase or state e.g., an austenitic state, an R-phase state, a composite state between austenitic and R-phase, etc.
  • the actuation elements 138 may have reduced (e.g., relatively less stiff) mechanical properties that cause the actuation elements to be more easily deformable (e.g., compressible, expandable, etc.) relative to when the actu
  • the actuation elements 138 may have increased (e.g., relatively stiffer) mechanical properties relative to the first matenal state, causing an increased preference toward a specific preferred geometry (e.g., original geometry, manufactured or fabricated geometry, heat set geometry, etc.).
  • a specific preferred geometry e.g., original geometry, manufactured or fabricated geometry, heat set geometry, etc.
  • Individual ones of the actuation elements 138 can be selectively and/or independently transitioned between the first material state and the second material state, for example, by applying energy (e.g., laser energy', heat energy, electrical energy, etc.) to one of the first actuation elements 138a or the second actuation elements 138b to heat it above a transition temperature (e.g., above an austenite finish (Ar) temperature, which is generally greater than body temperature).
  • energy e.g., laser energy', heat energy, electrical energy, etc.
  • a transition temperature e.g., above an austenite finish (Ar) temperature, which is generally greater than body temperature.
  • the first actuation element 138a (or the second actuation element 138b) is deformed relative to its preferred geometry when heated above the transition temperature, the first actuation element 138a (or the second actuation element 138b) will move to and/or toward its preferred geometry.
  • the first actuation element 138a and the second actuation element 138b are operably coupled such that, when the actuated actuation element (e.g., the first actuation element 138a) transitions toward its preferred geometry, the non-actuated actuation element (e.g., the second actuation element 138b) is further deformed relative to its preferred geometry.
  • the first actuation element 138a and the second actuation element 138b generally act in opposition.
  • the first actuation element 138a can be actuated to move the gating element 136 to and/or toward the first position
  • the second actuation element 138b can be actuated to move the associated gating element 136a-b to and/or toward the second position.
  • the orientation can be reversed, such that the first actuation element 138a can be actuated to move the associated gating element 136a-b to and/or toward the second position, and the second actuation element 138b can be actuated to move the associated gating element 136a-b to and/or toward the first position.
  • the first actuation element 138a and the second actuation element 138b can be coupled such that as one moves toward its preferred geometry upon material phase transition, the other is deformed relative to its preferred geometry. This enables the first and second actuation elements 138a-b of individual ones of the actuators 132 to be repeatedly actuated and the associated gating elements 136a-b to be repeatedly cycled between the first position and the second position.
  • one or more of the actuation elements 138 can include one or more targets 139 (individually identified as a first target 139a on the first actuation elements 138a and a second target 139b on the second actuation elements 138b in FIG. 1C).
  • the targets 139 can be thermally coupled to the corresponding actuation elements 138 such that energy (e.g., laser energy) received at the target 139 can dissipate through the corresponding actuation element 138 as heat.
  • the target 139 can therefore be selectively targeted with non-invasive energy to actuate the actuation elements 138.
  • heat/energy can be applied to the first target 139a, such as from an energy source positioned external to the patient’s eye (e.g., a laser).
  • the heat applied to the first target 139a spreads through at least a portion of the first actuation element 138a, which can heat the first actuation element 138a above its transition temperature.
  • heat/energy can be applied to the second target 139b.
  • the heat applied to the second target 139b spreads through the second actuation element 138b, which can heat at least the portion of the second actuation element 138b above its transition temperature.
  • the targets 139 are positioned generally centrally along a length of each individual actuation element 138. In other embodiments, however, the targets 139 can be positioned at an end region of each individual actuation element 138. In some embodiments, the targets 139 are composed of a same material (e.g., Nitinol) as the actuation elements 139. Without being bound by theory, the increased surface area of the targets 139 relative to the actuation elements 138 is expected to increase the ease and consistency by which the actuators 132 can be actuated using an energy source (e.g., a laser) positioned external to the body.
  • an energy source e.g., a laser
  • the actuation assembly 130 can further include a platform or base 141, an actuator hub 144 (“hub 144”), one or more second priming surfaces or features 146 (individually identified as second priming features 146a, 146b in FIG. 1C), and one or more hinge or folding elements 148 (individually identified as a first folding element 148a, a second folding element 148b, a third folding element 148c, and a fourth folding element 148d in FIG. 1C).
  • the folding elements 148 are spaced apart from each other to from gaps or spaces 149a-c (also labelled in FIG. ID) within the folding portion 150b and/or at least partially between the actuator portion 150a and the base portion 150c.
  • Individual ones of the folding elements 148, and/or one or more of the spaces 149a-c therebetween, can have a square shape, a rectangular shape, a trapezoidal shape, an arcuate shape, or another suitable shape.
  • the base 141 can include the actuator inlets 134, the second priming features 146, and the first priming features 142.
  • the folding elements 148 can couple the base 141 to the hub 144.
  • the hub 144 can be coupled to individual ones of the gating elements 136 by one or more of the actuation elements 138, such that the gating elements 136 are spaced apart from the hub 144.
  • the first and second gating elements 136a-b are both coupled to the hub 144 by the respective first and second actuation elements 138a-b.
  • FIG. ID is a perspective view of the actuation assembly 130 in the unfolded state 131b in accordance with embodiments of the present technology.
  • the actuation assembly 130 can include one or more sections or portions 150 (individually identified as a first or actuator portion 150a, a second or folding portion 150b, and a third, base, or priming portion 150c in FIG. ID).
  • Each of the portion 150a-c can include one or more of the aspects of the actuation assembly 130 that are described herein.
  • the actuator portion 150a includes the actuators 132 and the hub 144
  • the folding portion 150b includes the folding elements 148
  • the base portion 150c includes the base 141, the actuator inlets 134, the second priming features 146, and the first priming features 142.
  • the folding portion 150b can be positioned between the actuator portion 150a and the base portion 150c.
  • the actuation assembly 130 can be folded, transitioned, and/or otherwise transformed from the unfolded state 131b (FIG. ID) to the folded state 13 la (FIGS. lA and 1C) by rotating, pivoting, and/or otherwise moving the actuator portion 150a relative to the base portion 150c about the folding portion 150b, such as shown by arrow F, and/or moving the base portion 150c relative to the actuator portion 150a about the folding portion 150b, such as opposite the motion represented by the arrow F.
  • the unfolded state 131b FIG. ID
  • the actuation assembly 130 can have a planar geometry and the actuator portion 150a can be spaced apart from the base portion 150c (e.g., with the folding portion 150b between the actuator portion 150a and the base portion 150c).
  • the folded state 131a FIGS. 1A and 1C
  • at least part of one of the portions 150a-c can be deformed relative to the unfolded state 131b, such that at least a first part of the actuator portion 150a can contact at least a second part of the base portion 150c.
  • the actuator portion 150a is moved relative to the base portion 150c (e.g., by bending, curving, folding, deforming, etc.
  • each of the actuation elements 138 have a preferred or original length D when the actuation assembly 130 is in the unfolded state 13 lb.
  • At least a portion of the hub 144 such as one or more contact or retaining surfaces 145 of the hub 144 (individually identified as a first retaining surface 145a and a second retaining surface 145b in FIG. 1C), can contact one or more of the second priming features 146, and the recesses 137 of individual ones of the gating elements 136 can be positioned to contact the corresponding first priming features 142.
  • each of the actuation elements 138 can be deformed relative to their preferred geometry. For example, as shown in FIG.
  • each of the actuation elements 138 have a deformed length D' greater than the original length D (FIG. ID) and each of the actuation elements 138 are “stressed,” “strained,” “loaded,” or otherwise deformed relative to their preferred (e.g., original, as-manufactured) geometry.
  • the first and second priming features 142, 146 can each be positioned at or near opposite ends of the actuation elements 138, and the distance between the first and second priming features 142, 146 can be selected such that positioning the hub 144 to contact the second priming features 146 and positioning the recesses 137 to contact the first priming features 142 can thereby deform (e.g., strain, elongate, etc.) the actuation elements 138 relative to the preferred geometries to thereby “activate” or “prime” the actuation elements 138 for repeated actitation, e.g., to drive movement the gating elements 136 as described above.
  • deform e.g., strain, elongate, etc.
  • the distance between the second priming feature 146a and the first priming feature 142a can be configured such that positioning the first retaining surface 145a of the hub 144 to contact the second priming feature 146a and positioning the first recess 137a to contact the first priming feature 142a can thereby deform the first and second actuation elements 138a-b of the first actuator 132a relative to their preferred geometries, such that the first and second actuation elements 138a-b can be repeated actuated to move the first gating element 136a relative to the first actuator inlet 134a.
  • the distance between the second priming feature 146b and the first priming feature 142b can be configured such that positioning the second retaining surface 145b of the hub 144 to contact the second priming feature 146b and positioning the second recess 137b to contact the first priming feature 142b can thereby deform the first and second actuation elements 138a-b of the second actuator 132b relative to their preferred geometries, such that the first and second actuation elements 138a-b can be repeated actuated to move the second gating element 136b relative to the second actuator inlet 134b.
  • individual ones of the first priming features 142 and the second priming features 146 can be included in one or more priming components 152 (individually identified as a first priming component 152a including the first and second priming features 142a, 146b, and a second priming component 152b including the first and second priming features 142b, 146b in FIG. ID).
  • Each of the priming components 152 can be coupled to the base 141.
  • the first priming features 142a-b and the second priming features 146a-b define respective ends of the associated priming component 152a-b
  • each of the priming components 152a-b further include a respective priming component body 154a-b extending between (e.g., continuously between) the associated first priming features 142a-b and the corresponding second priming features 146a-b, such that the priming components 152 can be a unitary or unibody component.
  • the priming component bodies 154a-b can be positioned between the hub 144, the actuation elements 138a-b, and the corresponding gating element 134a-b.
  • the positioning of the priming component bodies 154a-b is expected to reduce or prevent inward buckling/deflection of the actuation elements 138a-b (e.g., for the first actuator 132a, the first actuation element 138a folding toward the second actuation element 138b) as the actuators 132a-b are transitioned between the first and second positions and/or improve the consistency and/or repeatability with which the actuators 132a-b can be transitioned between the first and second positions.
  • the actuation assembly 130 can be a unitary or contiguous structure (e.g., cut from, printed as, or deposited as a single piece of material).
  • each of the portions 150 and/or one or more of the elements thereof can be patterned (e.g., cut, laser cut, formed, cast, etc.) in, as, and/or from a single piece/sheet of material (e.g., Nitinol), and/or can correspond to regions of the single piece of material that were removed (e.g., during a subtractive manufacturing process), and/or where material was not added (e.g., during an additive manufacturing process).
  • a single piece/sheet of material e.g., Nitinol
  • transitioning the actuation assembly 130 between the unfolded and folded states 131a-b can include folding the single piece of material used to form the actuation assembly 130.
  • Forming the actuation assembly 130 from a single piece of material is expected to reduce or eliminate the variability in size and/or shape between individual elements of the actuation assembly 130, improve the tolerances between the individual elements of the actuation assembly 103, and/or create a more consistent strain/ deformation in the actuation elements 138 when the actuation assembly 130 is transitioned from the unfolded state 131b to the folded state 131a.
  • the actuation elements 138 are illustrated as operating under tension (e.g., elongated/strained relative to their preferred geometry) in FIGS. 1A, 1C, and ID, in other embodiments one or more of the actuators 132 can be configured to operate under compression.
  • one or more of the gating elements 136a-b can be positioned between the hub 144 and the corresponding first priming feature 142a-b, such that the first priming feature 142a-b can press the gating element 136a-b toward the hub 144 and thereby cause the associated actuation elements 138 to be shortened/compressed relative to their preferred geometries when the actuation assembly 130 is in the folded state 131a.
  • FIG. 2 is a perspective view of another actuation assembly 230 configured in accordance with embodiments of the present technology. At least some aspects of the actuation assembly 230 can be generally similar or identical in structure and/or function to the actuation assembly 130 ofFIGS. 1A, 1C, and ID. Accordingly, like names and/or reference numbers (e.g., unfolded state 231b versus the unfolded state 131b of FIG. ID) are used to indicate generally similar or identical aspects.
  • the actuation assembly 230 further includes a frame or border component 256 extending around at least a portion of the base 141.
  • the border component 256 can include an upper surface 258 and can define an interior or recessed area 260 of the base portion 150c.
  • individual ones of the actuator inlets 134 and the priming components 152 can be positioned within the recessed area 260.
  • the actuation assembly 230 is transitioned to the folded state (not shown)
  • at least part of the actuator portion 150a e.g., individual ones of the actuators 132, the hub 144, and/or one or more portions thereof
  • the border component 256 can be configured such that, in the folded state, the actuator portion L50a is positioned between the upper surface 258 and the base 141, such that the upper surface 258 defines an uppermost surface of the actuation assembly 230 in the folded state.
  • the border component 256 is expected to increase the stiffness of the base 141 and/or the base portion 150c. Accordingly, the border component 256 can reduce or prevent the base 141 and/or the base portion 150c from bending/flexing in response to movement of the actuator portion 150a relative to the base portion 150c, e.g., when transitioning the actuation assembly 230 from the unfolded state 231b (FIG. 2) to a folded state (not shown).
  • the border component 256 is further expected to reduce or prevent the base 141 and/or the base portion 150c from bending/flexing in response to response to forces applied to the base portion 150c by the actuator portion 150a, e.g., when the actuation elements 138 are deformed relative to their preferred geometries.
  • the upper surface 258 of the border component 256 can be configured to form a substantially fluid-impermeable seal with an interior portion of an adjustable shunting system, such as the system 100 of FIG. 1 A. Accordingly, when the actuation assembly 230 is transitioned to the folded state, the actuator portion 150a can be sealed within the recessed area 260, such that substantially all the fluid that enters the recessed area 260 can flow through individual ones of the actuator inlets 134.
  • the contact between the hub 144 and the priming components 152 is expected to at least partially prevent fluid within the recessed area 260 from leaking out of the recessed area 260 between the base 141 and the hub 144.
  • the hub 144 can be configured to form a substantially fluid-impermeable seal with the base 141 and/or the border component 256 when the actuation assembly is in the folded state.
  • one or more additional sealing elements such as one or more adhesives, can be applied to the base 141, the border component, and/or the hub 144 to further improve the leak resistance between these components when the actuation assembly 230 is in the folded state.
  • FIG. 3 is a perspective view of another actuation assembly 330 configured in accordance with embodiments of the present technology. At least some aspects of the actuation assembly 330 can be generally similar or identical in structure and/or function to the actuation assembly 130 of FIGS. 1A, 1C, and ID and/or the actuation assembly 230 of FIG. 2. Accordingly, like names and/or reference numbers (e.g., hub 344 versus the hub 144 of FIGS. 1C-2) are used to indicate generally similar or identical aspects.
  • the actuation assembly 330 includes a hub 344 having a different configuration than the hub 144 described previously.
  • the hub 344 includes a first hub region 362a, a second hub region 3 2b, and a hub surface 364 extending (e.g., vertically and/or at a slope or incline) therebetween.
  • the first hub region 362a has a first hub thickness and the second hub region 362b has a second hub thickness less than the first hub thickness.
  • the second hub region 362b can be thicker than the first hub region 362a, or the first and second hub regions 362a-b can each have another thickness.
  • the first hub region 362a can be coupled to the actuators 132, and the second hub region 362b can be coupled to the folding elements 348 (for illustrative clarity, only the fourth folding elements 348d is identified in FIG. 3).
  • the base 341 of the actuation assembly 330 can include a first base region 366a, a second base region 366b, and a base surface 368 extending (e.g., vertically and/or at a slope or incline) therebetween.
  • the first base region 366a has a first base thickness and the second base region 366b has a second base thickness less than the first base thickness.
  • the first base region 366a can have a same thickness as the first hub region 362a and/or the second base region 366b can have a same thickness as the second hub region 362b.
  • the second base region 366b can be thicker than the first base region 366a, or the first and second base regions 366a-b can each have another thickness.
  • the first base region 366a can include individual ones of the actuator inlets 134 and/or the priming components 152, and the second hub region 362b can be coupled to the folding elements 348.
  • the folding portion 350b of the actuation assembly 330 can include the second hub region 362b and the second base region 366b and/or can extend between the hub surface 364 and the base surface 386.
  • Individual ones of the folding elements 348 can have a same or different thickness than the second hub region 362b and/or the second base region 366b.
  • the second hub region 362b, the folding elements 348, and the second base region 366b each have the same thickness such that the folding portion 350b has a uniform thickness.
  • the folding portion 350b can have a different (e.g., reduced) thickness than the first hub region 362a and/or the first base region 366a.
  • the different thickness of the folding portion 350b relative to the rest of the actuation assembly 330 is expected to reduce the folding resistance of the actuation assembly 330 about the folding portion 350b and/or otherwise improve the ability of the actuation assembly 330 to be transitioned between the unfolded state 331b illustrated in FIG. 3 and a folded state (not shown).
  • FIG. 4A is a perspective view of another actuation assembly 430 in an unfolded state 431b in accordance with embodiments of the present technology.
  • FIG. 4B is a perspective view of the actuation assembly 430 in a folded state 431a and positioned within a plate assembly 420 in accordance with embodiments of the present technology.
  • select aspects of the plate assembly 420 are show n and other aspects omitted for the purpose of clarity.
  • At least some aspects of the actuation assembly 430 of FIGS. 4A and 4B can be at least generally similar or identical in structure and/or function to the actuation assembly 130 of FIGS. 1A, 1C, and ID, the actuation assembly 230 of FIG.
  • the plate assembly 420 can be at least generally similar or identical in structure and/or function to the plate assembly 120 of FIGS. 1A and IB. Accordingly, like names and/or reference numbers (e.g., hub 444 versus the hub 144 of FIGS. 1C-2 and/or the hub 344 of FIG. 3) are used to indicate generally similar or identical aspects.
  • the base 441 of the actuation assembly 430 can include a base surface 468 that can also be configured as the second priming surface or feature 446 (“base surface 468/second priming feature 446”).
  • the contact surface 445 of the hub 444 can be configured to contact the base surface 468/second priming feature 446 when the actuation assembly 430 is in the folded state 431a (FIG. 4B).
  • the hub 444 can have a greater thickness than the actuators 132 such that the contact surface 445 can contact the base surface 468/second priming feature 446 and the actuators 132 can be positioned to lay at least generally on the base 441 in the folded state 431a.
  • the first priming features 442 (individually identified as first priming features 442a-b in FIG. 4A) can be used to form respective pivot features 440 (individually identified as a first pivot feature 440a and a second pivot feature 440b in FIG. 4B).
  • the spacing between the first priming features 442 and the base surface 468/second priming feature 446 can be configured to deform the actuation elements 138 (one identified in FIGS. 4A and 4B) relative to their preferred geometries, as described in detail above with reference to FIGS. 1C and ID.
  • the hub 444 can further include one or more extensions or projections 470 (individually identified as a first projection 470a and a second projection 470b).
  • first projection 470a includes a portion of the hub 444 that extends outwardly relative to a first (e.g., left) side 472a of the base 441
  • second projection 470b includes a portion of the hub 444 that extends outwardly relative to a second (e.g., right) side 472b of the base 441, which can be opposite the first side 472b.
  • one or more of the projections 470 can be configured to aid (e.g., a user) in transitioning the actuation assembly 430 between the unfolded state 431b and the folded state 431a, and/or to aid (e.g., the user) in positioning the actuation assembly 430 within the chamber 421 of the plate assembly 420.
  • the user can grip or otherwise manipulate one or more of the projections 470 while transitioning the actuation assembly 330 between the unfolded state 431b and the folded state 431a.
  • the user can position one or more of the projections 470 to contact the plate assembly 420 to confirm that the actuation assembly 430 is seated within the plate assembly 420 and/or that the actuation elements 138 are deformed relative to their preferred geometries.
  • the chamber 421 is a slot (“slot 421”) formed through the plate assembly 420 and fluidly coupled to an inlet 404, and at least a portion of the base 441 and/or the actuators 132 can be positioned within the slot 421 when the actuation assembly 430 is in the folded state 431a.
  • the slot 421 can be configured to at least partially or fully prevent the actuation assembly 430 from transitioning (e.g., unfolding) from the folded state 431a to the unfolded state 431b.
  • the projections 470 can be configured to contact a first side 474a of the plate assembly 420 to at least partially prevent over-insertion of the actuation assembly 430 within the slot 421.
  • using the projections 470 to push the actuation assembly 430 into the slot 421 can thereby deform at least some or all of the actuation elements 138 relative to their preferred geometries, such as shown in FIG. 4B, for example, by driving the contact surface 445 of the hub 444 toward and/or against the base surface 468/second priming feature 446 to cause corresponding movement of the first priming features 442a-b.
  • the deformation of the actuation elements 138 can be complete when the projections 470 contact the first side 474a.
  • the slot 421 can be configured such that, when the actuation assembly 430 is positioned at least partially within the slot and/or when the projections 470 contact the first side 474a, substantially no fluid can exit the slot 421 through the first side 474a.
  • the slot 421 extends through a second side 474b of the plate assembly 420.
  • the slot 421 can be closed and/or sealed at the second side 474b, such that substantially no fluid can exit the slot 421 through the second side 474b.
  • FIG. 5A is a top view of another actuation assembly 530 in an unfolded state 531b and configured in accordance with embodiments of the present technology.
  • FIG. 5B is a perspective view of the actuation assembly 530 in a folded state 531a in accordance with embodiments of the present technology.
  • At least some aspects of the actuation assembly 530 of FIGS. 5A and 5B can be at least generally similar or identical in structure and/or function to the actuation assembly 130 of FIGS. 1A, 1C, and ID, the actuation assembly 230 of FIG. 2, the actuation assembly 330 of FIG. 3, and/or the actuation assembly 430 of FIGS. 4A and 4B.
  • each of the actuators 532 (individually identified as a first actuator 532a and a second actuator 532b) can include one or more priming appendages or tails 576 (individually identified as a first tail 576a of the first actuator 532a and a second tail 576b of the second actuator 532b).
  • the tails 576 can be positioned between actuation elements 538a-b of the actuators 532 and extend from gating elements 536a-b of the actuators 532 toward, e.g., the folding portion 550b of the actuation assembly 530.
  • Each of the tails 576 can include an end portion 537 (individually identified as a first end portion 537a of the first tail 576a and a second end portion 537b of the second tail 576b) positioned opposite the gating element 536.
  • one or more of the gating elements 536 can define an opening or aperture 578 (individually identified as a first opening 578a defined by the first gating element 536a and a second opening 578b defined by the second gating element 536b) extending through, or extending through at least a portion of, the gating element 536.
  • one or more balls e.g., silicone balls
  • other sealing elements can be positioned within the apertures 578.
  • the actuation assembly 530 can further include one or more retaining surfaces 545 (individually identified as a first retaining surface 545a and a second retaining surface 545b) positioned in, e.g., an actuator portion 550a of the actuation assembly 530.
  • Each of the retaining surfaces 545 can be positioned between the actuation elements 538a-b of one of the actuators 532 and/or proximate to (e.g., not contacting) the end portion 537 of the tails 576.
  • increasing a distance between the end portions 537 and the retaining surfaces 545 can prime the actuation elements 538 for actuation via energy (e.g., heat energy or non-invasive laser energy.
  • the actuation assembly 530 can further include one or more priming components 552 (individually identified as a first priming component 552a and a second priming component 552b) positioned in, e.g., a base or priming portion 550c of the actuation assembly 530.
  • Each of the priming components 552 can define a priming slot 542 (individually identified as a first priming slot 542a defined by the first priming component 552a and a second priming slot 542b defined by the second priming component 552b) configured to receive at least a portion (e.g., the end portion 537) of one of the tails 576.
  • the priming components 552 can further include one or more priming surfaces 546 (individually identified as a first priming surface 546a of the first priming component 552a and a second priming surface 5446b of the second priming component 552b) configured to contact a corresponding one of the retaining surfaces 545.
  • one or more priming surfaces 546 (individually identified as a first priming surface 546a of the first priming component 552a and a second priming surface 5446b of the second priming component 552b) configured to contact a corresponding one of the retaining surfaces 545.
  • one or more portions of the actuation assembly 530 include and/or define one or more mounting features 578 configured to releasably couple the actuation assembly 530 to, e.g., a plate assembly, such as the plate assembly 120 of FIG. 1A.
  • the actuator portion 550a defines a first mounting feature or slot 578a and the base or pnming portion 550c defines a second mounting feature or slot 578b.
  • the second slot 578b can be the mirror of the first slot 578a about the folding portion 550b so that, in the folded state 531a (FIG. 5B), the first slot 578a and the second slot 578b can be aligned with one another.
  • the actuator portion 550a, the folding portion 550b, and/or the priming portion 550c can include/ define more or fewer mounting features 578 and/or mounting features 578 having other suitable configurations.
  • At least part of the priming components 552 can be positioned between the retaining surfaces 545 and the tails 576. At least part of the tails 576 (e.g., the end portions 537) can be positioned within corresponding ones of the slots 542 and the priming surfaces 546 can be positioned to contact corresponding ones of the retaining surfaces 545.
  • the first end portion 537a of the first tail 576a is positioned within the first slot 542a
  • the second end portion 537b of the second tail 576b is positioned within the second slot 542b
  • the first priming surface 546a is positioned to contact the first retaining surface 545a
  • the second priming surface 546b is positioned to contact the second retaining surface 545b.
  • Positioning at least part of the priming components 552 between the tails 576 and the retaining surface 454 can increase a distance between the tails 576 and the retaining surfaces 545 and thereby prime the actuation elements 538 for actuation via energy.
  • increasing the distance between the tails 576 and retaining surfaces 545 can push or drive the gating elements 536 (which are coupled to the tails 576) away from the retaining surfaces 545. Because the actuation elements 538 are coupled to the gating elements 563, pushing/driving the gating elements 536 away from the retaining surfaces 545 can lengthen and/or otherwise deform the actuation elements 538 relative to a preferred geometry, thereby priming the actuation elements 538 for actuation via, e.g., non-invasive laser energy, as described previously herein.
  • the tails 576 can be deformable, e.g., configured to undergo elastic or at least generally elastic deformation, and can bend/deform to allow the gating elements 536 to move when, e.g., the actuation elements 538 are actuated.
  • FIG. 6 is a top view of another actuation assembly 630 in an unfolded state 631b and configured in accordance with embodiments of the present technology. At least some aspects of the actuation assembly 630 of FIG. 6 can be at least generally similar or identical in structure and/or function to the actuation assembly 530 of FIGS. 5A and 5B. Accordingly, like names and/or reference numbers (e.g., tails 676 of FIG. 6 versus the tails 576 of FIGS. 5A and 5B) are used to indicate generally similar or identical aspects. However, referring to FIG.
  • the actuation assembly 630 includes priming components 652 (individually identified as a first priming component 652a and a second priming component 652b) that are independently movable relative to one another. Accordingly, the actuation assembly 630 can be transitioned to a partially-folded state (not shown) in which one of the priming components 652 (e.g., the first priming component 652a) has been folded toward, e.g., one of the tails (e.g., the first tail 676a), without or substantially without moving or changing a position of the other priming component (e.g., the second priming component 652b).
  • a partially-folded state not shown
  • one of the priming components 652 e.g., the first priming component 652a
  • the tails e.g., the first tail 676a
  • the actuation assembly 630 can include and/or be configured to receive one or more sealing components 680 (individually identified as a first sealing component 680a and a second sealing component 680b).
  • the sealing components 680 includes balls or spherical components positioned within, or at least partially within, apertures 678a-b defined by the gating elements 636a-b. In other embodiments, however, one or more of the sealing components 680 can have other configurations.
  • FIG. 7 is a top view of another actuation assembly 730 in an unfolded state 731b and configured in accordance with embodiments of the present technology. At least some aspects of the actuation assembly 730 of FIG.
  • the actuation assembly 7 can be at least generally similar or identical in structure and/or function to the actuation assembly 530 of FIGS. 5A and 5B and/or the actuation assembly 630 of FIGS. 5A and 5B. Accordingly, like names and/or reference numbers (e.g., tails 776 versus the tails 676 of FIG. 6 and/or the tails 576 of FIGS. 5A and 5B) are used to indicate generally similar or identical aspects. Additionally, the actuation assembly 730 can include annular sealing elements 780 (individually identified as a first sealing elements 780a and a second sealing element 780b).
  • the sealing elements 780 can be positioned on/extend from the gating elements 736a-b and/or can be configured to be alignable with one or more channel inlets of an adjustable shunting system (e.g., one or more of the channel inlets 124a-c of the system 100 of FIG. 1A).
  • the sealing elements 780 can be aligned with (e.g., positioned over), or at least partially aligned with, a respective channel inlet to prevent, or at least partially prevent, fluid flow therethrough.
  • the actuation assembly 730 can be positioned in a plate assembly (e.g., the plate assembly 120 of FIG. 1A) with the sealing elements 780 facing the channel inlets.
  • the sealing elements 780 can contact a surface of the plate assembly including the channel inlets and at least part or all of the gating elements 736 can be spaced apart from the surface to, e.g., reduce contact between the gating elements 736 (and/or other portions of the actuators 732a-b) and the plate assembly to thereby reduce friction and/or other resistance to movement of the gating elements 736.
  • one or more of the sealing elements 780 can be pressed into and/or around the corresponding channel inlet to, e.g., form a substantially fluid-impermeable seal therewith.
  • the actuation assembly 730 includes/define one or more mounting apertures 778.
  • the actuator portion 750a defines two first mounting apertures 778ai-2 and the base or priming portion 750c also includes two second mounting apertures 778bi-2.
  • the second mounting apertures 778bi-2 can be mirrors of the first mounting apertures 778ai-2 about the folding portion 750b so that, when the actuation assembly 730 is transitioned to a folded state 73 la (FIG. 8), individual ones of the first mounting apertures 778ai-2 can be aligned with a corresponding one of the second mounting apertures 778bi-2.
  • FIG. 8 is a top view of the actuation assembly 730 in the folded state 731a and positioned within a plate assembly 820 in accordance with embodiments of the present technology. In the folded state 731a, individual ones of the mounting apertures 778 can be aligned with one another, as described above with reference to FIG.
  • a corresponding mounting portion 882 (individually identified as a first mounting portion 882a and a second mounting portion 882b) of the plate assembly 820 to, e.g., align the actuation assembly 730 with the plate assembly and/or prevent, or at least partially prevent, the actuation assembly 730 from moving relative to the plate assembly 820 during, e.g., actuation of the actuation assembly 730.
  • the plate assembly 820 can include/ define one or more system state indicators 884 (individually identified as first indicators 884a and second indicator 884b). Each of the indicators 884 can be positioned on or toward a side of a corresponding one of the actuators 732 and/or a portion thereof. In the illustrated embodiment, for example, the first indicators 884a are positioned on a first (e.g., right) side of the gating elements 736a-b of the actuators 732a-b and the second indicators 884b are positioned on a second (e.g., left) side of the gating elements 736a-b, opposite the first side and the first indicators 884a.
  • first indicators 884a are positioned on a first (e.g., right) side of the gating elements 736a-b of the actuators 732a-b
  • the second indicators 884b are positioned on a second (e.g., left) side of the gating elements 736a-b, opposite the first side and the first indicators
  • a user can observe the position of the corresponding gating element 736 relative to the indicators 884 to, e.g., determine whether and/or the extent to which the gating element 736 moved in response to the actuating input (e.g., the non-invasive laser energy).
  • the actuating input e.g., the non-invasive laser energy
  • the first gating element 736a would be expected to rotate toward the toward the first indicator 884a and/or away from the second indicator 884, e.g., in a clockwise direction.
  • the user can determine whether and/or the extent to which the first gating element 736a moved in response to the non-invasive laser energy.
  • An actuation assembly for use with an adjustable shunting system for draining fluid from a first body region to a second body region, the actuation assembly comprising: an actuator portion; a base portion; and a folding portion extending therebetween, wherein the actuation assembly is configured to be transitioned between a first state and a second state in response to at least one of (i) movement of the actuator portion relative to the base portion about the folding portion, or (ii) movement of the base portion relative to the actuator portion about the folding portion.
  • the base portion includes a priming component
  • the actuator portion includes a shape-memory actuation element having a preferred geometry
  • the priming component is positioned to cause the shape-memory actuation element to be deformed relative to the preferred geometry
  • the actuator portion includes an actuator having the shape-memory actuation element and a tail, wherein the priming component defines a slot, and wherein, in the second state, at least a portion of the tail is received within the slot.
  • the shape-memory actuation element is a first shape-memory actuation element
  • the actuator further includes a second shape-memory actuation element
  • the tail is positioned between the first shape-memory actuation element and the second shape-memory actuation element.
  • the priming component includes a first priming feature positioned to contact a first region of the actuator portion, and wherein the priming component further includes a second priming feature positioned to contact a second region of the actuator portion, and further wherein, in the second state, the first and second priming features are positioned to cause the shape-memory actuation element to be deformed relative to the preferred geometry.
  • the base portion includes a fluid port
  • the actuator portion includes an actuator
  • the actuator in the second state, the actuator is positioned to control fluid flow through the fluid port.
  • the actuator in the first state, the actuator is positioned on a first side of the folding portion and the fluid port is positioned on a second side of the folding portion; and in the second state, the actuator and the fluid port are positioned on a same side of the folding portion.
  • base portion further includes a base and a border component extending at least partially around the base.
  • actuation assembly of any one of examples 1-19 wherein the actuation assembly is configured to be transitioned between the first state and the second state in response to at least one of (i) rotational movement of the actuator portion relative to the base portion about the folding portion, or (ii) rotational movement of the base portion relative to the actuator portion about the folding portion.
  • the actuator portion includes an actuator hub and an actuator, wherein the actuator includes a gating element and a pair of shape-memory actuation elements extending between the gating element and the actuator hub, the base portion includes a first priming feature and a second priming feature, in the first state, individual ones of the shape-memory actuation elements have an original geometry, and in the second state, the actuator hub is configured to contact the second priming feature and the gating element is configured to contact the first priming feature to thereby deform at least one of the shape-memory actuation elements relative to the original geometry .
  • actuation assembly of any one of examples 23-30 further comprising a unitary priming component including the first priming feature, the second priming feature, and a priming component body extending therebetween.
  • An adjustable shunting system for draining fluid from a first body region to a second body region of a patient, the adjustable shunting system comprising: a channel; and an actuation assembly configured to control flow of fluid through the channel, wherein the actuation assembly includes — an actuator portion; a base portion; and a folding portion extending therebetween, wherein the actuation assembly is configured to be transitioned between a manufactured state and an operating state in response to at least one of (i) movement of the actuator portion relative to the base portion about the folding portion, or (ii) movement of the base portion relative to the actuator portion about the folding portion.
  • the actuator portion includes an actuator hub and an actuator, wherein the actuator includes a gating element and a pair of shape-memory actuation elements extending between the gating element and the actuator hub, the base portion includes a first priming feature and a second priming feature, in the manufactured state, individual ones of the shape-memory actuation elements have an original geometry, and in the operating state, the actuator hub is configured to contact the second priming feature and the gating element is configured to contact the first priming feature to thereby deform at least one of the shape-memory actuation elements relative to the original geometry .
  • the base portion includes a priming feature
  • the actuator portion includes a shape-memory actuation element having a preferred geometry
  • the priming feature is positioned to cause the shape-memory actuation element to be deformed relative to the preferred geometry
  • the priming feature is a first priming feature positioned to contact a first region of the actuator portion, the base portion further comprising a second priming feature positioned to contact a second region of the actuator portion, and wherein, in the operating state, the first and second priming features are positioned to cause the shape-memory' actuation element to be deformed relative to the preferred geometry'.
  • the adjustable shunting system of any one of examples 32-49 wherein: the base portion includes a fluid port, the actuator portion includes an actuator, and in the operating state, the actuator is positioned to control fluid flow through the fluid port.
  • the base portion further includes a base and a border component extending at least partially around the base.
  • the border component defines a recessed area of the base portion, and wherein, in the operating state, at least part of the actuator portion is positioned within the recessed area.
  • the actuator includes a gating element configured to control the flow of fluid through the channel, wherein base portion includes a priming feature configured to contact the gating element, and wherein, in the operating state, the actuation element is configured to move the gating element about the priming feature to at least partially allow or prevent fluid flow through the channel.
  • the actuation element is configured to move the gating element about the priming feature to at least partially allow or prevent fluid flow through the channel.
  • 61 The adjustable shunting system of any one of examples 32-60, further comprising a plate assembly, wherein the plate assembly includes the channel and a chamber fluidly coupled to the channel, and wherein at least a portion of the actuation assembly is configured to be positioned within the chamber.
  • actuation portion includes an actuator, wherein the actuator includes at least one shape-memory actuation element and a priming appendage, and wherein, in the operating state, the base portion is configured to contact the priming appendage and thereby cause the at least one shape-memory actuation element to be deformed relative to a preferred geometry .
  • the adjustable shunting system of example 62 wherein the at least one shapememory actuation element is a first shape-memory actuation element, wherein the actuator includes a second shape-memory actuation element, and wherein the priming appendage is positioned at least partially between the first shape-memory actuation element and the second shape-memory actuation element.
  • a method for manufacturing an adjustable shunting system comprising: forming an actuation assembly of the adjustable shunting system, wherein forming the actuation assembly includes forming at least one of (i) an actuator portion of the actuation assembly, (ii) a base portion of the actuation assembly, or (iii) a folding portion therebetween; and moving the actuator portion relative to the base portion about the folding portion, wherein the base portion includes a priming feature, the actuator portion includes an actuation element having an as-formed geometry, and wherein moving the actuator portion relative to the base portion includes causing the priming feature to deform the actuation element relative to the as-formed geometry.
  • moving the actuator portion relative to the base portion includes rotating the actuator portion relative to the base portion.
  • positioning the actuation assembly at least partially within the plate assembly includes aligning a gating element of the actuation assembly with a channel inlet of the plate assembly.
  • forming the actuation assembly includes forming the actuator portion, the base portion, and the folding portion.
  • forming the actuation assembly includes forming the actuation assembly from a single sheet of material.
  • the words “comprise,” “comprising,” and the like are to be construed in an inclusive sense, as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to.”
  • the terms “connected,” “coupled,” or any variant thereof means any connection or coupling, either direct or indirect, between two or more elements; the coupling of connection between the elements can be physical, logical, or a combination thereof.
  • the words “herein,” “above,” “below,” and words of similar import when used in this application, shall refer to this application as a whole and not to any particular portions of this application.

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Otolaryngology (AREA)
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Abstract

La présente invention concerne de manière générale des systèmes de dérivation réglables pour drainer un fluide d'une première région de corps à une seconde région de corps, comprenant des systèmes de dérivation réglables ayant des ensembles d'actionnement. Dans un mode de réalisation, un ensemble d'actionnement comprend une partie actionneur, une partie base et une partie de pliage s'étendant entre les deux. L'ensemble d'actionnement peut passer d'un état déplié à un état plié et inversement en réponse au déplacement de la partie actionneur par rapport à la partie base autour de la partie de pliage. Dans l'état plié, l'ensemble d'actionnement peut être configuré pour commander un fluide à travers le système de dérivation réglable.
PCT/US2023/071501 2022-08-03 2023-08-02 Systèmes de dérivation réglables comprenant des ensembles d'actionnement, et dispositifs et procédés associés WO2024030949A1 (fr)

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US202263394816P 2022-08-03 2022-08-03
US63/394,816 2022-08-03
US202363486636P 2023-02-23 2023-02-23
US63/486,636 2023-02-23

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6589203B1 (en) * 2000-01-26 2003-07-08 Peter Mitrev Glaucoma drainage device implant
US20050182350A1 (en) * 1996-10-25 2005-08-18 Alok Nigam Sutureless implantable device and method for treatment of glaucoma
US20090259236A2 (en) * 2003-07-28 2009-10-15 Baronova, Inc. Gastric retaining devices and methods
US20190038463A1 (en) * 2016-01-28 2019-02-07 Aq Biomed, Llc Ophthalamic implant for reduction of intraocular pressure in glaucomatous eyes and method of use
US20220142818A1 (en) * 2020-01-23 2022-05-12 Shifamed Holdings, Llc Adjustable flow glaucoma shunts and associated systems and methods
US20220203078A1 (en) * 2019-09-19 2022-06-30 Edwards Lifesciences Corporation Low-stress compressible implants

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050182350A1 (en) * 1996-10-25 2005-08-18 Alok Nigam Sutureless implantable device and method for treatment of glaucoma
US6589203B1 (en) * 2000-01-26 2003-07-08 Peter Mitrev Glaucoma drainage device implant
US20090259236A2 (en) * 2003-07-28 2009-10-15 Baronova, Inc. Gastric retaining devices and methods
US20190038463A1 (en) * 2016-01-28 2019-02-07 Aq Biomed, Llc Ophthalamic implant for reduction of intraocular pressure in glaucomatous eyes and method of use
US20220203078A1 (en) * 2019-09-19 2022-06-30 Edwards Lifesciences Corporation Low-stress compressible implants
US20220142818A1 (en) * 2020-01-23 2022-05-12 Shifamed Holdings, Llc Adjustable flow glaucoma shunts and associated systems and methods

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