Shunting systems with rotation-based flow control assemblies, and associated systems and methods
The shunt system with a rotary-based flow control assembly addresses the need for invasive adjustments in glaucoma treatment by using shape memory materials to non-invasively regulate fluid flow, enhancing treatment efficacy and safety.
Patent Information
- Application Number
- JP2025077896
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2021-01-22
- Filing Date
- 2025-05-08
- Publication Date
- 2025-07-25
AI Technical Summary
Existing glaucoma treatments face challenges in effectively managing intraocular pressure fluctuations due to the need for invasive surgical modifications to adjust fluid flow through implanted shunts, which can lead to complications such as hypotony and increased optic nerve damage.
A shunt system with a rotary-based flow control assembly that includes a drainage element and a rotatable control element, actuated by shape memory materials, allowing for non-invasive adjustment of fluid flow resistance through apertures using external energy sources.
Enables precise and non-invasive control of fluid flow through the shunt, reducing the need for additional surgeries and minimizing complications by adapting to individual patient needs, thus maintaining optimal intraocular pressure.
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Figure 2025109781000001_ABST
Abstract
Description
Technical Field
[0001] Cross - Reference to Related Applications This application claims priority to the following co - pending applications: U.S. Provisional Patent Application No. 62 / 976,890, filed on February 14, 2020, U.S. Provisional Patent Application No. 62 / 981,411, filed on February 25, 2020, U.S. Provisional Patent Application No. 63 / 116,674, filed on November 20, 2020, and U.S. Provisional Patent Application No. 63 / 140,543, filed on January 22, 2021.
[0002] All of the foregoing applications are hereby incorporated by reference in their entirety. Further, the components and features of the embodiments disclosed in the applications incorporated by reference may be combined with the various components and features disclosed and claimed in this application.
[0003] The present technology generally relates to implantable medical devices, particularly to intraocular shunt systems, and related methods for selectively controlling fluid flow between different parts of a patient's eye.
Background Art
[0004] Glaucoma is a degenerative eye condition associated with damage to the optic nerve that can lead to progressive and irreversible vision loss. Glaucoma is often associated with elevated intraocular pressure, an increase in the pressure within the eye, and can result from an increase in the production of aqueous humor ("water") within the eye and / or a decrease in the rate of outflow of water from the eye into the bloodstream. Water is produced in the ciliary body, which is located at the boundary between the posterior and anterior chambers of the eye. The water flows into the anterior chamber and ultimately into the capillary bed within the sclera of the eye. Glaucoma is typically caused by a disorder within the mechanism that transports water from the eye into the bloodstream.
Summary of the Invention
Means for Solving the Problems
[0005] This technology generally relates to a shunt system for selectively controlling the flow of fluid between a first body region of a patient, such as the anterior chamber of the patient's eye, and a second body region of the patient, such as the bleb space. The shunt system disclosed herein can include a drainage element having a channel extending therethrough for transporting fluid from the first body region to the second body region. The shunt system can also include a control element rotatably movable relative to the drainage element and at least one shape memory actuating element that, when actuated, pivots or otherwise rotates the control element relative to the drainage element. By pivoting / rotating the control element, the fluid resistance through one or more apertures (e.g., fluid inlets) in fluid communication with the channel is changed, thereby changing the drainage rate through the drainage element. As will be described in detail below, it is expected that using rotational motion to control the flow of fluid through the shunt system provides several advantages over fluid control elements that rely on linear motion. The present invention provides, for example, the following items. (Item 1) A system for selectively controlling fluid flow in a patient, the system comprising: A drainage element having a channel extending therethrough and an aperture in fluid communication with the channel; and An actuator coupled to the drainage element and configured to control the flow of fluid through the aperture, the actuator comprising: A control element having a first region rotatably anchored to the drainage element and a second region spaced from the first region and rotatably movable relative to the drainage element; and A first actuating element coupled to the first region of the control element, the first actuating element being configured to rotate the second region of the control element in a first direction when actuated; A second actuating element coupled to the first region of the control element, wherein when the second actuating element is actuated, the second actuating element is configured to rotate the second region of the control element in a second direction different from the first direction, the second actuating element; A system comprising: (Item 2) The system according to item 1, wherein the control element is an elongated protrusion. (Item 3) The system according to item 1, wherein the second region of the control element is configured to interface with the aperture and control the flow of fluid therethrough. (Item 4) The system according to item 3, wherein the second region is movable between a first position providing a first flow resistance through the aperture and a second position providing a second flow resistance through the aperture different from the first resistance. (Item 5) The system according to item 4, wherein the control element exhibits substantially no reaction when moved from the first position to the second position. (Item 6) A first target element configured to receive energy from an external energy source and disperse heat into the first actuating element; A second target element configured to receive energy from the external energy source and disperse heat into the second actuating element; further comprising: The system according to item 1, wherein the first target element and the second target element can be independently energized. (Item 7) The system according to item 6, wherein the first target element is positioned at a central portion of the first actuating element, and the second target element is positioned at a central portion of the second actuating element. (Item 8) The system according to item 6, wherein the control element, the first actuating element, the second actuating element, the first target element, and the second target element constitute an integral structure. (Item 9) The system according to item 8, wherein the integral structure is composed of a shape memory material. (Item 10) The system according to item 6, wherein the first target element and the second target element are anchored to the drainage element. (Item 11) The system according to item 1, wherein the actuator is anchored to the drainage element at at least three locations. (Item 12) The system according to item 1, wherein the actuator includes at least three rotational degrees of freedom with respect to the drainage element. (Item 13) The system according to item 1, wherein the first actuating element and the second actuating element are composed of a shape memory material. (Item 14) The system according to item 1, wherein the drainage element includes a substantially rigid inner structure that houses the actuator and a semi-flexible outer structure that at least partially encloses the substantially rigid inner structure. (Item 15) The system according to item 14, wherein the substantially rigid inner structure is a plate, the semi-flexible outer structure is a casing, and the plate forms a fluid seal with the casing to prevent fluid leakage between the plate and the casing. (Item 16) The system according to item 14, wherein the semi-flexible outer structure includes an opening, the substantially rigid inner structure includes an aperture, and the aperture is aligned with the opening. (Item 17) The channel is a first channel, the aperture is a first aperture, the actuator is a first actuator, and the system further comprises a second channel, a second aperture in fluid communication with the second channel, and a second actuator configured to control the flow resistance through the second actuator, wherein the second actuator can be operated independently of the first actuator. The system according to item 1. (Item 18) The system according to item 1, wherein the system is an intraocular shunt system for draining fluid from the anterior chamber of the patient's eye. (Item 19) A system for selectively controlling fluid flow in a patient, the system comprising: A drainage element having a channel extending therethrough and an aperture in fluid communication with the channel; An actuator coupled to the drainage element and configured to control the flow of fluid through the aperture, the actuator comprising: A control element pivotally movable relative to the drainage element; A first actuating element coupled to the control element, the first actuating element being configured such that when actuated, the control element is pivotally movable in a first direction; A second actuating element coupled to the control element, the second actuating element being configured such that when actuated, the control element is pivotally movable in a second direction different from the first direction. A system comprising: (Item 20) The system according to item 19, wherein the control element is an elongated protrusion. (Item 21) The system according to item 19, further comprising a blocking mechanism, wherein the control element interfaces with the aperture and is configured to control the flow of fluid therethrough. (Item 22) The system according to item 21, wherein the shut-off mechanism is pivotally movable between a first position that shuts off or substantially shuts off fluid flow through the aperture and a second position that allows fluid flow to the aperture. (Item 23) The system according to item 19, wherein the shut-off mechanism exhibits substantially no reaction when moved from the first position to the second position. (Item 24) A first target element configured to receive energy from an external energy source and disperse heat within the first actuating element, and A second target element configured to receive energy from the external energy source and disperse heat within the second actuating element, further comprising: The system according to item 19, wherein the first target element and the second target element can be independently energized. (Item 25) The system according to item 24, wherein the first target element is positioned at a central portion of the first actuating element, and the second target element is positioned at a central portion of the second actuating element. (Item 26) The system according to item 24, wherein the control element, the first actuating element, the second actuating element, the first target element, and the second target element form an integral structure. (Item 27) The system according to item 26, wherein the integral structure is composed of a shape memory material. (Item 28) The system according to item 19, wherein the first actuating element and the second actuating element are composed of a shape memory material. (Item 29) The system according to item 19, wherein the drain element includes a substantially rigid inner structure that houses the actuator and a semi-flexible outer structure that at least partially encloses the substantially rigid inner structure. (Item 30) The system according to item 29, wherein the substantially rigid inner structure is a plate, the semi-flexible outer structure is a casing, and the plate forms a fluid seal with the casing to prevent fluid leakage between the plate and the casing. (Item 31) The system according to item 29, wherein the semi-flexible outer structure includes an opening, the substantially rigid inner structure includes an aperture, and the aperture is aligned with the opening. (Item 32) The system according to item 19, wherein the channel is a first channel, the aperture is a first aperture, the actuator is a first actuator, the system further includes a second channel, a second aperture in fluid communication with the second channel, and a second actuator configured to control the flow resistance through the second actuator, and the second actuator can be operated independently of the first actuator. (Item 33) The system according to item 19, wherein the system is an intraocular shunt system for draining fluid from the anterior chamber of the patient's eye. (Item 34) A shunt system for selectively controlling fluid flow from the anterior chamber of a patient's eye, the system comprising a drainage element having an inflow portion configured to be installed within the anterior chamber outside the visual field of the patient's vision and an outflow portion configured to be installed at a different location of the eye, an actuator, a rotary control element operably coupled to the inflow portion and / or the outflow portion of the drainage element, and an actuating element coupled to the rotary control element and configured to selectively change the orientation of the rotary control element. A shunt system in which the fluid resistance through the inlet portion and / or the outlet portion varies based on the selected orientation of the rotary control element. (Item 35) The system according to item 34, wherein the inlet portion comprises one or more apertures that allow fluid flow therethrough, and the rotary control element is operably coupled to the inlet portion. (Item 36) The rotary control element is movable between a first orientation and a second orientation, in the first orientation, the rotary control element at least partially interferes with one or more apertures, in the second orientation, the one or more apertures are accessible and the rotary control element is at least partially spaced apart from the one or more apertures, the system according to item 35. (Item 37) The system according to item 34, wherein the actuating element is configured to change its geometric shape in response to a stimulus, and the change in the geometric shape changes the orientation of the rotary control element. (Item 38) The actuating element is a first actuating element, the actuator is coupled to the rotary control element, and further comprises a second actuating element configured to selectively change the orientation of the rotary control element, when the first actuating element is actuated, it is configured to rotationally move the rotary control element in a first direction, when the second actuating element is actuated, it is configured to rotationally move the rotary control element in a second direction, the second direction being opposite to the first direction, the system according to item 34. (Item 39) The system according to item 34, wherein the rotary control element is an elongated protrusion. (Item 40) A method for controlling the flow of fluid through an adjustable shunt system having a drainage element and a control element configured to interface with an aperture in fluid communication with the drainage element, the method comprising: shunting fluid from a first body region of a patient to a second body region of the patient via the drainage element; selectively adjusting the drainage rate of the fluid through the drainage element by pivotally moving an elongate control element relative to the drainage element, wherein pivotally moving the elongate control element varies and adjusts the flow resistance through the aperture. (Item 41) The method of item 40, wherein selectively adjusting the drainage rate includes decreasing the drainage rate by pivotally moving the elongate control element to increase the flow resistance through the aperture. (Item 42) The method of item 40, wherein selectively adjusting the drainage rate includes increasing the drainage rate by pivotally moving the elongate control element to decrease the flow resistance through the aperture. (Item 43) The method of item 40, wherein pivotally moving the elongate control element includes moving the control element towards or away from the aperture. (Item 44) The method of item 40, wherein pivotally moving the elongate control element includes rotating a first end portion of the elongate control element about a pivotable anchor such that a second end portion of the elongate control element rotates relative to the drainage element. (Item 45) The method of item 40, wherein pivotally moving the elongate control element includes actuating a shape memory actuating element operably coupled to the elongate control element. (Item 46) The method according to item 45, wherein actuating the shape memory actuating element includes delivering energy from an energy source positioned outside the patient's body to a shape memory actuator. (Item 47) The method according to item 45, wherein actuating the shape memory actuator includes changing the geometric shape of the shape memory actuating element. (Item 48) The method according to item 40, wherein the first body region is the anterior chamber of the patient's eye, the second body region is another part of the patient's eye spaced apart from the anterior chamber, and the fluid is water. (Item 49) A method of manufacturing an adjustable flow shunt system, the method comprising: fabricating an actuator at least partially composed of a shape memory material, the actuator having one or more actuating elements and a rotary control element; fixing the actuator to a drainage element; deforming the actuator with respect to its fabricated geometric shape, wherein when the actuator is deformed and fixed to the drainage element, the rotary control element is configured to rotatably interface with one or more apertures on the drainage element to at least partially control the flow of fluid therethrough. (Item 50) The method according to item 49, wherein deforming the actuator with respect to its fabricated geometric shape includes coupling a first portion of the actuator to a second portion of the actuator. (Item 51) The method according to item 49, wherein deforming the actuator with respect to its fabricated geometric shape includes stretching the actuating element. (Item 52) The method according to item 49, wherein deforming the actuator with respect to its fabricated geometric shape includes compressing the actuating element. (Item 53) The method according to item 49, wherein the actuator is fixed to the drainage element, causing the actuator to deform with respect to the fabricated geometric shape. (Item 54) The method according to item 49, wherein deforming the actuator with respect to the fabricated geometric shape is performed after fixing the actuator to the drainage element. (Item 55) The method according to item 49, wherein fixing the actuator to the drainage element includes sealing the shunt system such that fluid can pass only through the one or more apertures. (Item 56) The method according to item 49, wherein fixing the deformed actuator to the drainage element includes rotatably coupling a portion of the actuator to the drainage element.
Brief Description of the Drawings
[0006] Many aspects of the present technology can be better understood with reference to the following drawings. The components in the drawings are not necessarily drawn to scale. Instead, emphasis is placed on clearly illustrating the principles of the present technology. Additionally, components may be shown as transparent in a particular figure merely to clarify the illustration and do not necessarily indicate that the illustrated components are actually transparent. Also, components may be shown schematically.
[0007]
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DETAILED DESCRIPTION OF THE INVENTION
[0008] The technical terms used in the description presented below are intended to be interpreted in the broadest reasonable manner even when used in conjunction with a detailed description of specific embodiments of the present technology. Certain terms may even be emphasized below, however, any technical terms intended to be interpreted in a restricted manner are clearly and specifically defined as such in this "DETAILED DESCRIPTION OF THE INVENTION" section. Further, the present technology can include other embodiments that are within the scope of the examples but are not described in detail with respect to FIGS. 1-17.
[0009] Throughout this specification, when reference is made to "one embodiment" or "an embodiment", it means that the particular feature, structure, or characteristic described in connection with that embodiment is included in at least one embodiment of the present technology. Thus, when the phrases "in one embodiment" or "in an embodiment" appear in various places throughout this specification, they are not necessarily all referring to the same embodiment. Further, the particular features or characteristics can be combined in any suitable manner in one or more embodiments.
[0010] Throughout this specification, when referring to relative terms such as, for example, "generally", "approximately", and "about", this specification is used to mean plus or minus 10% of the recited value. References throughout this specification to the term "resistance" refer to fluid resistance, unless the context clearly dictates otherwise. The terms "drainage rate", "flow rate", and "flow" are used interchangeably to describe the movement of fluid through a structure.
[0011] Certain embodiments of this specification are described with respect to a shunt for fluid from the anterior chamber of the eye, but those skilled in the art will understand that the technology can be readily adapted to shunt fluid from other parts of the eye and / or between other parts of the eye, and more generally, from a first body region and a second body region and / or between a first body region and a second body region. Further, certain embodiments of this specification are described in the context of glaucoma treatment, but any embodiment of this specification, including what is referred to as a "glaucoma shunt" or "glaucoma device", can 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 fluid accumulation, including, but not limited to, heart failure (e.g., heart failure maintaining ejection fraction, heart failure with reduced ejection fraction, etc.), lung failure, kidney failure, hydrocephalus, etc. Further, although generally described with respect to shunting water, the systems described herein can equally be applied to shunt other fluids, such as blood or cerebrospinal fluid, between a first body region and a second body region.
[0012] The headings provided herein are for convenience only and do not interpret the scope or meaning of the claimed technology.
[0013] A. Intraocular shunt for glaucoma treatment Glaucoma refers to a group of eye diseases associated with damage to the optic nerve, ultimately causing vision loss and blindness. As described above, glaucoma is a degenerative eye condition characterized by increased intraocular pressure resulting from increased production of aqueous humor within the eye and / or decreased outflow rate of aqueous humor from the eye into the bloodstream. The increased pressure leads to damage to the optic nerve over time. Unfortunately, patients often do not exhibit symptoms of increased intraocular pressure until glaucoma develops. Therefore, patients typically must be closely monitored for increased pressure even when asymptomatic. Since monitoring continues throughout the course of the disease, clinicians can intervene early to halt the progression of the disease. To monitor pressure, patients need to visit a clinic regularly, which is expensive, time-consuming, and inconvenient. The early stages of glaucoma are typically treated with medications (e.g., eye drops) and / or laser treatment. However, when medications / laser treatment are insufficient, a surgical approach can be used. Surgical or minimally invasive approaches attempt to increase the outflow of aqueous humor from the anterior chamber into the bloodstream, mainly either by creating an alternative fluid pathway or enhancing the natural pathway for aqueous humor outflow.
[0014] Figures 1A and 1B show suitable locations within the human eye E where a shunt according to embodiments of the present technology can be implanted. More specifically, FIG. 1A is a simplified front view of the eye E with the shunt 100 implanted, and FIG. 1B is an isometric view of the eye E and the shunt 100 of FIG. 1A. Referring first to FIG. 1A, the eye E includes several muscles for controlling its movement, including the superior rectus muscle SR, the inferior rectus muscle IR, the lateral rectus muscle LR, the medial rectus muscle MR, the superior oblique muscle SO, and the inferior oblique muscle IO. The eye E also includes the iris, the pupil, and the limbus.
[0015] Referring to both FIGS. 1A and 1B, shunt 100 can have a drainage element 105 (e.g., a drainage tube) positioned such that an inflow portion 101 is positioned within the anterior chamber of the eye E and an outflow portion 102 is positioned at a different location within the eye E, such as in the bleb space. The shunt 100 can be implanted in various orientations. For example, when implanted, the drainage element 105 can extend upward, downward, inward, and / or outward from the anterior chamber. Depending on the design of the shunt 100, the outflow portion 102 can be placed at several different suitable outflow locations (e.g., between the choroid and the sclera, between the conjunctiva and the sclera, etc.).
[0016] Outflow resistance can change over time, for example, during the healing process after surgical implantation of a shunt (e.g., shunt 100, etc.), or due to various reasons such as further obstruction within the drainage network that passes from the anterior chamber through the trabecular meshwork, Schlemm's canal, collector channels, and ultimately into the veins and the body's circulatory system. Thus, a clinician may desire to modify the shunt after implantation in order to either increase or decrease the outflow resistance in response to such changes or other clinical reasons. For example, in many procedures, the shunt is modified at the time of implantation to temporarily increase the outflow resistance. After a certain period of time determined to be sufficient to allow tissue healing and stabilization of the outflow resistance, the modification to the shunt is reversed, thereby decreasing the outflow resistance. In another example, a clinician can implant the shunt and then, after monitoring the intraocular pressure, determine whether a modification to the drainage rate through the shunt is desired. Such modifications can be invasive, time-consuming, and / or expensive for the patient. However, failure to follow such procedures can increase the likelihood of creating hypotony (excessively low intraocular pressure), which can lead to further complications, including damage to the optic nerve. In contrast, an intraocular shunt system configured according to embodiments of the present technology allows a clinician to selectively adjust the flow of fluid through the shunt after implantation without additional invasive surgical procedures.
[0017] The shunts described herein are implanted with a first drainage rate and can then be remotely adjusted to achieve a second, different drainage rate. The adjustment can be based on the needs of the individual patient. For example, the shunt can be implanted at a first, lower flow rate and then adjusted to a second, higher flow rate if clinically necessary. The shunts described herein can be delivered using either ab interno or ab externo implant techniques and can be delivered via a needle. The needle can have various shapes and configurations to accommodate the various shapes of the shunts described herein. Details of the implant technique, implant device, and bleb formation are described in more detail by International Patent Application No. PCT / US20 / 41152, the disclosure of which is incorporated herein by reference for all purposes.
[0018] In many of the embodiments described herein, the flow control assembly is configured to introduce features that selectively impede or attenuate fluid flow through the shunt during operation. In this way, the flow control assembly can gradually or continuously change the flow resistance through the shunt to selectively regulate pressure and / or flow. Thus, a flow control assembly configured in accordance with the present technology can adjust the level of interference or compression between several different locations and accommodate many variables (e.g., IOP, aqueous production rate, native aqueous outflow resistance, and / or native aqueous outflow rate) to accurately regulate the flow rate through the shunt.
[0019] The disclosed flow control assembly can operate using energy. This feature allows such a device to be implanted within a patient and modified / adjusted over time without the need for additional invasive surgery or procedures on the patient. Further, since the devices disclosed herein can be actuated via energy from an external energy source (e.g., a laser), such devices do not require any additional power to maintain a desired orientation or position. Rather, the actuator / fluid resistors disclosed herein can maintain a desired position / orientation without power. This can significantly increase the useful life of such devices and enable such devices to remain effective long after an initial implant procedure.
[0020] B. Operation of the Actuating Element Some embodiments of the present technology include an actuating assembly (e.g., a flow control assembly, a flow control mechanism, etc.) having at least one actuating element coupled to a movable control element (e.g., an arm, a gate element, a protrusion, etc.). As will be described in detail below, the movable control element can be configured to interface (e.g., at least partially block) with a corresponding port or aperture. The port can be an inlet port or an outlet port. The movement of the actuating element generates movement (e.g., translational and / or rotational) of the movable element.
[0021] The actuating element can include a shape memory material (e.g., a shape memory alloy or a shape memory polymer). The movement of the actuating element can be generated by the application of stress and / or the use of a shape memory effect (e.g., driven by a temperature change). The shape memory effect can cause a deformation that has modified the element from its preferred geometric configuration (e.g., original or fabricated configuration, shape set configuration, heat set configuration, etc.) to be mostly or completely reversed during the operation of the fluid control assembly. For example, thermal actuation (heating) can reverse the deformation by inducing a change in the state of the actuator material (e.g., a phase change), inducing an increase in temporary internal stress that promotes a change in shape to the preferred geometric configuration. In the case of a shape memory alloy, the change in state can be a change from a martensite phase (alternatively, an R phase) to an austenite phase. In the case of a shape memory polymer, the change in state can be due to a glass transition temperature or a melting temperature. The change in state can reverse the deformation of the material, e.g., the deformation relative to its preferred geometric configuration, without applying any (e.g., external) stress to the actuating element. That is, a deformation imparted to the material at a first temperature (e.g., body temperature) can be (e.g., thermally) recovered and / or modified by raising the material to a second (e.g., higher) temperature. When cooled (and the state changes, e.g., returns to the martensite phase), the actuating element retains its preferred geometric configuration. When the material is in this relatively lower temperature state, the force or stress required to elastically deform the material can be reduced, and then, when an external stress is applied, the actuating element can be deformed again from its original geometric configuration.
[0022] The actuating element can be processed such that the transition temperature (e.g., the austenite start temperature, the austenite finish temperature, etc.) at which a change in state occurs exceeds a threshold temperature (e.g., body temperature). For example, the transition temperature can be set to about 45°C, about 50°C, about 55°C, or about 60°C. In some embodiments, the actuator material is heated from body temperature to a temperature above the austenite start temperature (or alternatively, above the R-phase start temperature) such that the upper plateau stress of the material in the first state (e.g., the thermoelastic martensite phase or the thermoelastic R-phase at body temperature) (e.g., "UPS_body temperature") is lower than the upper plateau stress of the material in the heated state (e.g., the superelastic state) (e.g., "UPS_operating temperature"), thereby achieving partial or complete free recovery. For example, the actuator material can be heated such that UPS_operating temperature > UPS_body temperature. In some embodiments, the actuator material is heated from body temperature to a temperature above the austenite start temperature (or alternatively, above the R-phase start temperature) such that the upper plateau stress of the material in the first state (e.g., thermoelastic martensite or thermoelastic R-phase at body temperature) is lower than the lower plateau stress of the material in the heated state (e.g., "LPS"), thereby achieving partial or complete free recovery. For example, the actuator material can be aged such that LPS_activation temperature > UPS_body temperature. In some embodiments, the actuator material is heated from body temperature to a temperature above the austenite start temperature (or alternatively, above the R-phase start temperature) such that the upper plateau stress of the material in the first state (e.g., thermoelastic martensite or thermoelastic R-phase) is higher than the lower plateau stress of the material in the heated state, thereby achieving partial or complete free recovery. For example, the actuator material can be aged such that LPS_activation temperature < UPS_body temperature.
[0023] The flow control assembly can be formed such that the actuating elements have a preferred geometric configuration (e.g., a memory shape, or length, L0) that is substantially the same. When the flow control assembly is introduced (e.g., implanted) into a patient, at least one (e.g., a first) actuating / shape memory element is deformed relative to its preferred geometric configuration (e.g., such that L1≠L0), while at least one other opposing (e.g., a second) actuating / shape memory element positioned adjacent to the first actuating element can be assembled such that it is substantially in its preferred geometric configuration (e.g., L0). However, in other embodiments, both the first and second actuating elements can be deformed relative to their corresponding preferred geometric configurations when introduced into the patient (e.g., the first actuating element is contracted relative to its preferred geometric configuration and the second actuating element is expanded relative to its preferred geometric configuration).
[0024] In some embodiments of the present technology, L1>L0. For example, the deformed first actuating element is stretched relative to its preferred “shape memory” length. In some embodiments, L1<L0. For example, the deformed first actuating element is compressed relative to its preferred shape memory length. The flow control assembly can be formed such that its overall dimensions (e.g., overall length) are substantially fixed during operation (e.g., L0+L1 = constant). For example, the (e.g., outermost) end portions of the actuating elements can be fixed such that movement of the actuating elements occurs between fixed points. Along with the length, the overall geometric shape of the actuating elements can be selected such that deformation within the actuating elements remains less than about 10%, about 9%, about 8%, about 7%, or about 6% during operation.
[0025] (For example, the first and second) actuating elements are arranged such that movement (e.g., deflection or deformation) of the first actuating element / first shape memory element is accompanied by (e.g., causes) an opposing movement of the second actuating element / second shape memory element. The movement can be deflection or deformation. During operation, selective heating of the first actuating element of the flow control assembly moves and / or biases the first actuating element to its preferred geometric configuration (e.g., back from L1 to L0), moving the coupled movable element. At the same time, the stretching of the first actuating element is accompanied by (e.g., causes) compression of the second actuating element (e.g., from L0 to L1). The second actuating element is not heated (e.g., remains at body temperature), and thus, the second actuating element deforms (e.g., remains martensitic and compresses). The first actuating element cools after heating and returns to a plastically deformable state. To reverse the configuration (e.g., position of the movable element) of the flow control assembly, the second actuating element is heated to move and / or bias it to its preferred geometric configuration (e.g., from L1 to L0). As the second actuating element returns to its preferred geometric configuration, the movable element moves back to its previous position and the first actuating element compresses (e.g., from L0 to L1). The position of the movable element of the flow control assembly can be repeatedly toggled (e.g., between an open and a closed state) by repeating the aforementioned operations. Heating of the actuating elements can be achieved by applying incident energy (e.g., via a laser or inductive coupling). Further, as mentioned above, the incident energy source can be outside the patient's body (e.g., non-invasive).
[0026] C. Flow control assembly for an intraocular shunt system As described above, the present technology generally targets an intraocular shunt system. Such a system includes a drainage element (e.g., an elongated flow tube or plate) configured to shunt fluid away from the anterior chamber of the eye. For example, the drainage element can include an inflow portion configured to be disposed within the anterior chamber (e.g., at a location away from the visual field of vision) and an outflow portion configured to be disposed at a different location of the eye (e.g., the subconjunctival bleb space). To selectively control the fluid flow through the drainage element (e.g., after implantation), the system can further include a flow control assembly operably coupled to the drainage element. In some embodiments, the flow control assembly includes a rotary control element operably coupled to a portion of the drainage element (e.g., the outflow portion or the inflow portion). The rotary control element can be or can include a cam, a plate, a lever, a gate valve, or any other structure that can rotate in multiple different orientations, and the orientation of the rotary control element or its components can affect the amount of fluid flow through a portion of the drainage element.
[0027] FIG. 2 is a front view of a flow control assembly 200 of an intraocular shunt system configured according to an embodiment of the present technology. The flow control assembly 200 includes a rotary control element 202 coupled to an actuating structure 204. The rotary control element 202 can include an elongated member 205 having a first end portion 206a, a second end portion 206b, and a cam portion 206c disposed between the first end portion 206a and the second end portion 206b. The elongated member 205 can be configured to rotate about a rotation axis A1 (e.g., in a clockwise and / or counterclockwise direction). In some embodiments, the cam portion 206c includes an aperture 208 configured to receive a fastener (e.g., a pin, a screw, a pivot, etc. - not shown) that enables rotation of the elongated member 205 about the rotation axis A1.
[0028] The rotary control element 202 is operably coupled to the outflow portion of a drainage element (not shown) to selectively control the fluid flow therethrough (e.g., to adjust the pressure within the anterior chamber of the eye). For example, the outflow portion can include one or more apertures formed therein to permit fluid outflow (e.g., similar to the outflow port 102 described with respect to FIGS. 1A and 1B). The rotary control element 202 can be positioned near or adjacent to the aperture such that, depending on the orientation of the rotary control element 202, one or more apertures can be blocked or unblocked by the rotary control element 202. When rotated to a first orientation, the rotary control element 202 can cover the aperture partially or completely to partially or completely block fluid flow from the aperture. When rotated to a second orientation, the rotary control element 202 can be spaced from the aperture such that the aperture is accessible and fluid can flow therethrough with little or no blockage. As a result, the amount of fluid flow through the outflow portion can vary based on the number of blocked apertures and / or the degree to which each aperture is blocked. In other embodiments, the rotary control element 202 is coupled to the inflow portion of a drainage element (not shown) such that one or more inflow apertures (not shown) can be blocked or unblocked, or partially to fully blocked or unblocked, by the rotary control element 202.
[0029] In the illustrated embodiment, for example, the elongate member 205 or its components (e.g., the cam portion 206c, the first end portion 206a, and / or the second end portion 206b) can be positioned near or adjacent to the aperture of the outflow portion of a drainage element (not shown). When the elongate member 205 is rotated to a first orientation, the cam portion 206c can cover the aperture partially or completely. In some embodiments, when the elongate member 205 is rotated to a second orientation, the notch 209 formed in the cam portion 206c can be positioned over the aperture such that the cam portion 206c is spaced from the aperture and no longer blocks fluid flow therethrough.
[0030] The actuating structure 204 can be configured to effect rotation of the rotary control element 202. In the illustrated embodiment, for example, the actuating structure 204 includes a first actuating element 208a and a second actuating element 208b coupled to the rotary control element 202 (e.g., to the elongate member 205). The first and second actuating elements 208a-b can each be supported by a base support 210 and can extend longitudinally between the base support 210 and the rotary control element 202. For example, the first actuating element 208a can include a first end portion 212a coupled to the base support 210 and a second end portion 212b coupled to the first end portion 206a of the elongate member 205. The second actuating element 208b can include a first end portion 214a coupled to the base support 210 and a second end portion 214b coupled to the second end portion 206b of the elongate member 205.
[0031] In some embodiments, the first and second actuating elements 208a-b include one or more shape memory materials configured to at least partially transition from a first phase / state (e.g., a martensite state or an intermediate state) to a second phase / state (e.g., an intermediate state or an austenite state) when energy is applied, as described above. The first and second actuating elements 208a-b can each be configured to change or transform shape by a shape memory effect (e.g., when heated) between a first configuration (e.g., a memory shape, a preferred geometric shape, etc.) and a second configuration (e.g., a shape different from the memory shape, a deformed geometric shape, etc.). For example, in some embodiments, the memory shape is an extended configuration, while in other embodiments, the memory shape is a contracted configuration.
[0032] In the illustrated embodiment, the first actuating element 208a, when heated, can be configured to transform into an extended configuration and rotatably move the rotary control element 202 along a first direction (e.g., counterclockwise), and the second actuating element 208b, when heated, can be configured to transform into an extended configuration and rotatably move the rotary control element 202 along a second, opposite direction (e.g., clockwise). In other embodiments, the first actuating element 208a, when heated, can be configured to transform into a contracted configuration and rotatably move the rotary control element 202 along a first direction (e.g., clockwise), and the second actuating element 208b, when heated, can be configured to transform into a contracted configuration and rotatably move the rotary control element 202 along a second, opposite direction (e.g., counterclockwise). Optionally, the first and second actuating elements 208a-b can be configured to face each other such that the actuation of one actuating element due to the shape memory effect generates corresponding deflection and / or deformation of the other actuating element. For example, the transformation of one actuating element into an extended configuration can cause the transformation of the other actuating element into a contracted configuration, and / or the transformation of one actuating element into a contracted configuration can cause the transformation of the other actuating element into an extended configuration.
[0033] The geometric shapes of the first and second actuating elements 208a-b can be configured in several different ways. For example, in the illustrated embodiment, the first and second actuating elements 208a-b each include a plurality of vertices or bend regions 216 and a plurality of struts 218 that are interconnected with each other to form a meandering or "zigzag" shaped structure (reference numbers are shown only for the vertices and struts of the first actuating element 208a for clarity purposes). The first and second actuating elements 208a-b can each transform into an extended configuration by moving the vertices 216 and / or struts 218 further apart from each other (e.g., along the longitudinal direction). Conversely, the first and section actuating elements 208a-b can each transform into a contracted configuration by moving the vertices 216 and / or struts 218 closer to each other (e.g., along the longitudinal direction).
[0034] In some embodiments, each of the first and second actuating elements 208a - b is individually actuated by applying a stimulus to the entire actuating element. In other embodiments, the stimulus can be applied to only a portion of the actuating element. For example, the stimulus can be applied at a plurality of different locations, such as one or more vertices 216 and / or one or more struts 218 of a selected actuating element. In such embodiments, the stimulus can be applied simultaneously to each of the different locations, or at different times (e.g., sequentially) to different locations. As a result, the degree of shape change can be adjusted based on the number of locations where the stimulus is applied. For example, applying the stimulus to more locations can generate a larger shape change, while applying the stimulus to a smaller number of locations can generate a smaller shape change.
[0035] It will be understood that the first and second actuating elements 208a - b can be configured in several different ways to enable the rotational - based actuation of the rotary control element 202. For example, FIG. 2 shows the first and second actuating elements 208a - b each having four vertices 216 and three struts 218, but in other embodiments, the first and second actuating elements 208a - b can include a different number of vertices (e.g., 1, 2, 3, 5, or more) and / or a different number of struts (e.g., 1, 2, 4, 5, or more). Further, FIG. 2 shows the vertices 216 as being curved and the struts 218 as being linear, but in other embodiments, the vertices 216 and / or the struts 218 can have other geometric shapes (e.g., curved, linear, curvilinear, angular, etc.).
[0036] FIG. 3 is a front view of a flow control assembly 300 of an intraocular shunt system configured in accordance with another embodiment of the present technology. The flow control assembly 300 may be substantially similar to the flow control assembly 200 described with respect to FIG. 2, and like reference numerals (e.g., rotary control element 202 vs. rotary control element 302) are used to identify like or identical components. Thus, the discussion of the flow control assembly 300 of FIG. 3 will be limited to features that are different from those of the flow control assembly 200 of FIG. 2.
[0037] The flow control assembly 300 includes a rotary control element 302 having an elongated member 305 with a first end portion 306a, a second end portion 306b, and a cam portion 306c therebetween. The first and second end portions 306a-b may each include respective retaining mechanisms (e.g., first retaining mechanism 320a and second retaining mechanism 320b) formed therein. The flow control assembly 300 further includes an actuating structure 304 having a first actuating element 308a and a second actuating element 308b. The first actuating element 308a can include a first end portion 312a coupled to a base support 310 and a second end portion 312b engaged with the first retaining mechanism 320a. The second actuating element 308b can include a first end portion 314a coupled to the base support 310 and a second end portion 314b engaged with the second retaining mechanism 320b. In some embodiments, the first and second retaining mechanisms 320a-b each include a channel formed therein, and the second end portions 312b, 314b are shaped to be received within the corresponding channels. The first and second retaining mechanisms 320a-b can be sized larger than their respective second end portions 312b, 314b such that the second end portions 312b, 314b can move therein. When the shapes of the first and second actuating elements 308a-b change (e.g., by the shape memory effect described herein), the second end portions 312b, 314b can slide within their respective channels to rotatably move the rotary control element 302.
[0038] Figures 4A - 4C show a flow control assembly 400 of an intraocular shunt system configured in accordance with a further embodiment of the present technology. More specifically, FIG. 4A is a front view of the assembly 400, FIG. 4B is a front view of a first plate member 420 of the assembly 400, and FIG. 4C is a front view of a second plate member 430 of the assembly 400 positioned within the first plate member 420.
[0039] Referring first to FIG. 4A, the flow control assembly 400 includes a rotary control element 402 coupled to an actuating structure 404. The rotary control element 402 can include an elongate member 405 configured to rotate in a plurality of different orientations (e.g., about a rotation axis A2). The actuating structure 404 can include a first actuating element 408a and a second actuating element 408b coupled to the elongate member 405 and supported by a base support 410. The actuating structure 404 and the elongate member 405 can be the same as or substantially similar to the corresponding components described previously with respect to FIGS. 2 and 3. Thus, the discussion of the flow control assembly 400 of FIG. 4 will be limited to those features that are different from the embodiments of FIGS. 2 and 3.
[0040] Referring to FIGS. 4A - 4C together, the rotary control element 402 further includes a first plate member 420 and a second plate member 430 configured to move rotatably relative to the first plate member 420. As best seen in FIG. 4B, the first plate member 420 can have a generally flat shape and can include an inlet 422, an outlet 424, and a recess 426 between the inlet 422 and the outlet 424. The inlet 422 and the outlet 424 can each include one or more apertures, openings, ports, channels, etc. formed in a peripheral portion 428 of the first plate member 420 surrounding the recess 426. The inlet 422 can be fluidly coupled to an outflow portion and / or an inflow portion of a drainage element (e.g., to shunt fluid from the anterior chamber of the eye - not shown). The outlet 424 can be fluidly coupled to a location within the eye (e.g., the subconjunctival bleb space).
[0041] As best seen in FIG. 4C, the second plate member 430 can have a generally flat shape and can be positioned within the recess 426 of the first plate member 420. Positioning of the second plate member 430 within the recess 426 can define a flow channel 432 that fluidly couples the inlet 422 and the outlet 424. For example, in the illustrated embodiment, the second plate member 430 has a shape similar to the recess 426, but has a smaller size (e.g., a smaller surface area) such that the flow channel 432 is at least partially defined by a gap between the second plate member 430 and the peripheral portion 428 of the first plate member 430. In the illustrated embodiment, the gap extends around the entire periphery of the second plate member 430. In other embodiments, the gap can extend only partially around the periphery of the second plate member 430.
[0042] The rotary control element 402 can be configured to control the amount of fluid flow through the flow channel 432 based on the orientation of the second plate member 430 relative to the first plate member 420. In some embodiments, the second plate member 430 can be configured to rotate about a rotation axis A2 relative to the first plate member 420 (e.g., in a clockwise and / or counterclockwise direction). Optionally, the second plate member 430 can be rotatably coupled to the first plate member 420 by a fastener (e.g., a pin, screw, pivot, etc. - not shown) received within an aperture 434 formed in the second plate member 430.
[0043] The second plate member 430 can have a shape configured such that the geometry (e.g., size and / or shape) of the flow channel 432 changes as the second plate member 430 rotates. As a result, the fluid flow through the flow channel 432 can be selectively adjusted by rotating the second plate member 430 to a plurality of different orientations. For example, rotation of the second plate member 430 can increase or decrease the cross-sectional area of the flow channel 432. As another example, rotation of the second plate member 432 can cause one or more portions of the flow channel 432 to be blocked or unblocked. As yet another example, rotation of the second plate member 430 can cause the inlet 422 and / or the outlet 424 to be blocked or unblocked. In the illustrated embodiment, the second plate member 430 includes a protrusion 436. When in the first orientation (e.g., as shown in FIG. 4C), the protrusion 436 can be positioned away from the outlet 424, such that fluid flow can pass through with little or no blockage. When rotated to the second orientation (e.g., rotated clockwise), the protrusion 436 can move near or adjacent to the outlet 424 and / or within a portion of the flow channel 432 near the outlet 424, thereby partially or completely blocking the fluid flow through the outlet 424.
[0044] Referring back to FIG. 4A, the rotation of the second plate member 430 can be actuated by the actuation structure 404. In some embodiments, the second plate member 430 is coupled to the actuation structure 404 via an elongate member 405. For example, the first and second actuation elements 408a-b can be coupled to the elongate member 405 to control its rotation. The elongate member 405 can be coupled to the second plate member 430 such that rotation of the elongate member 405 generates a corresponding rotation of the second plate member 430 (e.g., clockwise or counterclockwise about the axis of rotation A2). In other embodiments, the elongate member 405 can be omitted such that the actuation structure 404 is directly coupled to the second plate member 430 to control its rotation. The technique by which the actuation structure 404 actuates the rotation of the elongate member 405 and / or the second plate member 430 can be the same or substantially similar to the embodiments previously described with respect to FIGS. 2 and 3. For example, the first and second actuation elements 408a-b can include a shape memory material configured to change shape when heated to rotate the elongate member 405 and / or the second plate member 430.
[0045] It will be understood that the fluid control assembly 400 can be configured in several different ways. For example, FIGS. 4A-4C show the first plate member 420 as having a generally circular shape, but in other embodiments, the first plate member 420 can have a different shape (e.g., elliptical, square, rectangular, polygonal, etc.). The shape of the second plate member 430 can also be varied as needed. Further, the geometry of the recess 426 and / or the second plate member 430 can be configured in several different ways to selectively modify the geometry and / or the flow resistance characteristics of the flow channel 432. For example, in other embodiments, the protrusion 436 can be located near the inlet 422 instead of the outlet 424, or the second plate member 430 can include a plurality of protrusions at different locations with respect to the inlet 422, the outlet 424, and / or the flow channel 432.
[0046] Figures 5A and 5B are, respectively, a top view and a side cross-sectional view of a flow control assembly 500 of an intraocular shunt system configured according to a further embodiment of the present technology. Referring to Figures 5A and 5B together, the flow control assembly 500 includes a rotary control element 502 coupled to an actuating structure 504 (the actuating structure 504 is omitted from Figure 5B for clarity only). The rotary control element 502 can include a first plate member 520 coupled to a second plate member 530. The first plate member 520 can be positioned directly below the second plate member 530. The first and second plate members 520, 530 can each have a generally flat shape (e.g., circular, elliptical, square, rectangular, polygonal, or other shape). In the illustrated embodiment, the first and second plate members 520, 530 have the same shape but different sizes (e.g., the first plate member 520 is larger than the second plate member 530). In other embodiments, the first and second plate members 520, 530 can have different shapes.
[0047] The first plate member 520 can include a first fluid channel 522. The first fluid channel 522 can be fluidly coupled to a location within the eye (e.g., the subconjunctival bleb space). As best seen in FIG. 5B, the first fluid channel 522 can include an outer section 524a located outside the first plate member 520 and an inner section 524b formed within the first plate member 520. In the illustrated embodiment, the outer section 524a is coupled to a side surface 526a of the first plate member 520, and the inner section 524b extends through the first plate member 520 from the side surface 526a to the top surface 526b of the first plate member 520. In other embodiments, the outer section 524a can be coupled to a different portion of the first plate member 520 (e.g., a different side surface or the bottom surface), and the inner section 524b can extend through the first plate member 520 from that portion to the top surface 526b. Alternatively, the outer section 524a can be omitted such that the first fluid channel 522 includes only the inner section 524b.
[0048] The second plate member 530 can include a second fluid channel 532. The second fluid channel 532 can be fluidly coupled to the outflow portion of the drainage element (e.g., for shunting fluid from the anterior chamber of the eye - not shown). As best seen in FIG. 5B, the second fluid channel 532 can include an outer section 534a located outside the second plate member 530 and an inner section 534b formed within the second plate member 530. In the illustrated embodiment, the outer section 534a is coupled to the upper surface 536a of the second plate member 530, and the inner section 534b extends through the second plate member 530 from the upper surface 536a to the lower surface 536b of the second plate member 530. In other embodiments, the outer section 534a can be coupled to a different portion (e.g., a side surface) of the second plate member 530, and the inner section 534b can extend through the second plate member 530 from that location to the lower surface 526b. Alternatively, the outer section 534a can be omitted such that the second fluid channel 532 includes only the inner section 534b.
[0049] In some embodiments, the second plate member 530 is configured to move rotatably relative to the first plate member 520 (e.g., about the axis of rotation A3) to change the position of the second flow channel 532 relative to the first flow channel 522. As a result, depending on the orientation of the second plate member 530 relative to the first plate member 520, the first and second flow channels 522, 532 can be aligned with each other (e.g., as shown in FIG. 5B) to permit fluid passing therethrough, or offset from each other to reduce or prevent fluid flow passing therethrough. For example, when the first and second flow channels 522, 532 are aligned, the inner section 524b of the first flow channel 522 is aligned and fluidly coupled with the inner section 534b of the second flow channel 532, thereby creating an unobstructed flow path that permits fluid flow passing therethrough. As a result, fluid can flow from a part of the eye (e.g., the anterior chamber), through the second flow channel 532, through the first flow channel 522, and out to a different location of the eye. Conversely, when the first and second flow channels 522, 532 are offset from each other, the inner section 524b of the first flow channel 522 can be offset and fluidly decoupled from the inner section 534b of the second flow channel 532, thereby reducing or preventing fluid flow passing therethrough.
[0050] Referring again to FIG. 5A, the rotation of the second plate member 530 can be actuated by an actuation structure 504. The actuation structure 504 can include a first actuation element 508a and a second actuation element 508b. In the illustrated embodiment, the first and second actuation elements 508a-b each include respective first end portions 512a, 514a coupled to the second plate member 530 and respective second end portions 512b, 514b coupled to the first plate member 520. In other embodiments, the first end portions 512a, 514a can be coupled to the first plate member 520, and the second end portions 512b, 514b can be coupled to the second plate member 530. The first and second actuation elements 508a-b can each be an elongated structure (e.g., a spring such as a strut, a leaf spring or a coil spring wound around a guide wire, a coil, a wire, etc.) that at least partially extends along the periphery of the second plate member 530. In the illustrated embodiment, the first and second actuation elements 508a-b are positioned at opposing peripheral portions of the second plate member 530.
[0051] In some embodiments, the first and second actuation elements 508a-b include one or more shape memory materials configured to at least partially transition from a first phase / state (e.g., a martensite state or an intermediate state) to a second phase / state (e.g., an intermediate state or an austenite state) when energy is applied, as described above. The first and second actuation elements 208a-b can each change or transform in shape by a shape memory effect (e.g., when heated) between a first configuration (e.g., a memory shape, a preferred geometric shape, etc.) and a second configuration (e.g., a shape different from the memory shape, a deformed geometric shape, etc.) to drive the rotation of the second plate member 530. For example, in some embodiments, the memory shape is an extended configuration, and in other embodiments, the memory shape is a contracted configuration.
[0052] For example, in the illustrated embodiment, the first actuating element 508a is configured to transform into an extended configuration when heated and rotate the second plate member 530 along a first direction (e.g., clockwise), and the second actuating element 508b is configured to transform into an extended configuration when heated and rotate the second plate member 530 along a second, opposite direction (e.g., counterclockwise). Alternatively or in combination, the first actuating element 508a can be configured to transform into a contracted configuration when heated and rotate the second plate member 530 along a first direction (e.g., counterclockwise), and the second actuating element 508b can be configured to transform into an extended configuration when heated and rotate the second plate member 530 along a second, opposite direction (e.g., clockwise). Optionally, the first and second actuating elements 508a-b can be configured to face each other such that the actuation of one actuating element due to the shape memory effect generates a corresponding deflection and / or deformation of the other actuating element. For example, the transformation of one actuating element into an extended configuration can cause the transformation of the other actuating element into a contracted configuration, and / or the transformation of one actuating element into a contracted configuration can cause the transformation of the other actuating element into an extended configuration. The rotation of the first plate member 530 can be driven by the shape change of the first and second actuating elements 508a-b to control the alignment of the first and second flow channels 522, 532.
[0053] Figures 6A-6C show a flow control assembly 600 of an intraocular shunt system configured according to another embodiment of the present technology. More specifically, FIG. 6A is a front view of the assembly 600 in an unloaded and / or uncompressed configuration, FIG. 6B is a front view of the assembly 600 in a loaded and / or compressed configuration, and FIG. 6C is a front view of the assembly 600 in a rotated configuration.
[0054] Referring to FIGS. 6A - 6C together, the flow control assembly 600 includes a frame structure 602. The frame structure 602 can include a first strut 604a and a second strut 604b that are coupled to each other by an upper segment 606. The first and second struts 604a - b can each have a generally linear shape. The first and second struts 604a - b can each extend along the longitudinal axis of the frame structure 602 and can each be coupled to first and second curved segments 608a - b, respectively. The first and second curved segments 608a - b can be connected to each other by a base segment 610. The base segment 610 can be coupled to a pin element 612. The pin element 612 can be an elongated, generally linear structure that extends along the longitudinal axis of the frame structure 602 toward the upper segment 606 and terminates at an end portion 614. In some embodiments, the first and second struts 604a - b, the upper segment 606, the first and second curved segments 608a - b, the base segment 610, and the pin element 612 are integrally formed with respect to each other such that the frame structure 602 is manufactured as a single, unitary component. In other embodiments, one or more of the components of the frame structure 602 are manufactured separately and then coupled to each other to form the frame structure 602.
[0055] The frame structure 602 can initially be in a fabricated or un-tensioned configuration (e.g., an unloaded and / or uncompressed configuration as shown in FIG. 6A) where the pin element 612 is positioned away from the upper segment 606. Subsequently, the frame structure 602 can be placed in a tensioned configuration (e.g., a loaded and / or compressed configuration as shown in FIG. 6B) by moving the base segment 610 and the pin element 612 towards the upper segment 606 until the end portion 614 of the pin element 612 engages a retaining mechanism 616 formed in the upper segment 606. For example, the retaining mechanism 616 can be a notch, groove, aperture, or other structure suitable for holding the end portion 614 therein. The end portion 614 of the pin element 612 can include a flange, lip, protrusion, or any other structure suitable for engaging the retaining mechanism 616 and fixing the pin element 612 thereto. In some embodiments, the frame structure 602 is manufactured in an un-tensioned configuration and then placed in a tensioned configuration for use (e.g., before, during, or after implantation into a patient's eye).
[0056] In some embodiments, the base segment 610 functions as a rotary control element for selectively controlling fluid flow through a drainage element (e.g., for shunting fluid from the anterior chamber of the eye - not shown). For example, the base segment 610 can be positioned near or adjacent to one or more apertures of an outflow portion or an inflow portion of a drainage element (not shown). When in a first orientation (e.g., as shown in FIG. 6B), the base segment 610 can cover the aperture partially or completely, thereby partially or completely blocking fluid flow from the aperture. When rotated to a second orientation (e.g., counterclockwise as shown in FIG. 6C), the base segment 610 can be spaced apart from the aperture, allowing fluid flow therethrough with little or no blockage.
[0057] The first curved segment 608a and / or the second curved segment 608b can function as an actuating structure for rotating the base segment 610 to selectively adjust fluid flow. In the illustrated embodiment, for example, the second curved segment 608b is made of one or more shape memory materials configured to at least partially transition from a first phase / state (e.g., a martensite state or an intermediate state) to a second phase / state (e.g., an intermediate state or an austenite state) when energy is applied, as previously described. When energy is applied, the second curved segment 608b can undergo a phase transition that hardens it and / or changes its shape to a contracted configuration. As a result, the base segment 610 can rotate / pivot in a counterclockwise direction toward the second curved segment 608b, as shown, for example, in FIG. 6C and indicated by arrow A. Optionally, in some embodiments, the first curved segment 608a is also made of a shape memory material configured to actuate the rotation of the base segment 610. When energy is applied to the first curved segment 608a, hardening and / or a change in shape to a contracted configuration is possible, thus rotating / pivoting the base segment 610 in a clockwise direction toward the first curved segment 608a. As a result, the first and second curved segments 608a - b can oppose each other to enable the base segment 610 to rotate / pivot in two opposite directions.
[0058] Figures 7A - 7E illustrate an intraocular shunt system 10 (the "system 10") configured in accordance with selected embodiments of the present technology. More specifically, FIG. 7A is a front view of the system 10, FIG. 7B is an enlarged front view of the flow control assembly 700 of the system 10 cut away from the area identified in FIG. 7A, FIG. 7C is an enlarged front view of the actuator 701a of the flow control assembly 700, FIG. 7D is an enlarged front view of the actuator 701 in a first configuration, and FIG. 7E is an enlarged front view of the actuator 701 in a second, different configuration.
[0059] Referring initially to FIG. 7A, the system 10 includes a flow control assembly 700 and a casing, plate, or drainage element 750. The drainage element 750 can extend between a first end portion 750a and a second end portion 750b and can have a generally flat outer profile. When implanted in a patient's eye, the first end portion 750a can be at least partially within the internal region of the eye (e.g., the anterior chamber), and the second end portion 750b can be at least partially within and / or in fluid communication with a desired outflow location (e.g., the subconjunctival bleb space).
[0060] In some embodiments, the drainage element 750 can include a plurality of discrete components. For example, the drainage element 750 can include a generally rigid inner structure 751 (e.g., plastic or other rigid block, plate, etc.) that encapsulates or is configured to encapsulate the flow control assembly 700 and is positioned at the first end portion 750a of the drainage element 750. The drainage element 750 can further include a semi-flexible outer structure 753 (e.g., silicone or other flexible shell, casing, etc.) that holds the first inner structure and extends between the first end portion 750a and the second end portion 750b of the drainage element 750. For example, the generally rigid inner structure 751 can have a length of about 1 mm to about 5 mm, such as about 2 mm to 3 mm, and the semi-flexible outer structure 753 can have a length of about 6 mm to about 13 mm, such as about 8 mm to 10 mm. In such embodiments, the generally rigid inner structure 751 can form a fluid seal with the semi-flexible outer structure 753 to prevent fluid leakage therebetween.
[0061] The drainage element 750 can have a plurality of lumens or channels extending between a first end portion 750a and a second end portion 750b. In the illustrated embodiment, for example, the drainage element 750 includes a first channel 752a, a second channel 752b, and a third channel 752c (collectively referred to herein as channels 752). As will be described in more detail below, when the system 10 is implanted into a patient's eye, aqueous humor can be drained through the channels 752 from the anterior chamber to a desired outflow location. The channels 752 can have the same or different cross-sectional dimensions and / or areas. For example, in some embodiments, the first channel 752a has a first diameter, the second channel 752b has a second diameter that is larger than the first diameter, and the third channel 752c has a third diameter that is larger than the second diameter. In embodiments where the channels 752 have different dimensions (e.g., diameters), the fluid resistance through each of the channels 752 can be different. Although shown as having three channels 752, the system 10 can include more or fewer channels 752, such as one, two, four, five, six, seven, eight, or more.
[0062] As will be described in more detail with respect to FIG. 7B, the flow control assembly 700 can include one or more actuators for controlling the flow of water into the channel 752. For example, the flow control assembly 700 can include a first actuator 701a for controlling the flow of water through the first channel 752a, a second actuator 701b for controlling the flow of water through the second channel 752b, and a third actuator 701c for controlling the flow of water through the third channel 752c (collectively referred to as the actuator 701). Although shown as having three actuators 701, the system 10 can include more or fewer actuators 701, such as one, two, four, five, six, seven, eight, or more. In some embodiments, the number of actuators 701 can be the same as the number of channels 752, but in other embodiments, the system 10 can have a different number of actuators 701 and channels 752. In some embodiments, the system 10 includes a single actuator 701 for controlling the flow through a single channel that extends through the drainage element.
[0063] Referring now to FIG. 7B, the actuator 701 is positioned within respective chambers defined by the drain element 750 and one or more inner wall structures 730 (which may be part of a generally rigid inner structure 751). For example, the first actuator 701a is positioned within the first chamber 732a, the second actuator 701b is positioned within the second chamber 732b, and the third actuator 701c is positioned within the third chamber 732c (collectively referred to herein as chambers 732). The first chamber 732a can be in fluid communication with the first channel 752a (e.g., via the first port 734a), the second chamber 732b can be in fluid communication with the second channel 752b (e.g., via the second port 734b), and the third chamber 732c can be in fluid communication with the third channel 752c (e.g., via the third port 734c). In some embodiments, the chambers 732 can be fluidly isolated from each other to prevent fluid from flowing between the chambers 732. As shown below, by fluidly isolating the chambers 732, the system 10 can provide a more titratable / fine-grained treatment by allowing a healthcare provider to select from among multiple treatment levels.
[0064] The drainage element 750 can include, in at least some configurations, a first fluid inlet 716a (shown as a single aperture 716a) that can fluidly communicate the first chamber 732a to the environment external to the first end portion 750a of the drainage element 750. The drainage element 750 can further include, in at least some configurations, a second fluid inlet 716b (shown as two apertures) that can fluidly communicate the second chamber 732b to the environment external to the first end portion 750a of the drainage element 750. The drainage element 750 can further include, in at least some configurations, a third fluid inlet 716c (shown as four apertures 716c) that can fluidly communicate the third chamber 732c to the environment external to the first end portion 750a of the drainage element 750. When the system 10 is implanted intraocularly, the environment external to the first end portion 750a of the drainage element 750 can include the anterior chamber of the eye. Thus, in at least some configurations, water can flow into the chamber 732 through each fluid inlet of the drainage element 750. The water can then be drained from the chamber 732 through each channel 752. As will be described in more detail below, the fluid resistance of the system 10, and thus the drainage of water through the system 10, can be selectively controlled by selectively blocking and / or unblocking the fluid inlet 716 by selectively activating the actuator 701.
[0065] The drainage element 750 can also include a first transmission region 756a and a second transmission region 756b (collectively referred to as the transmission region 756). In some embodiments, the transmission region 756 can have a lower absorbance than the surrounding structure so that energy (e.g., light, laser energy, etc.) can pass through the transmission region with relatively low absorbance or deflection. In some embodiments, the transmission region 756 can be of a different material and / or different properties than the surrounding structure. In some embodiments, the transmission region 756 is composed of the same material as the surrounding structure, but nevertheless provides a target for the user to direct energy towards. In some embodiments, the transmission region 756 is an opening of the drainage element 750. When the first actuator 701a is fixed to the drainage element 750, as described below, the target region on the first actuator 701a aligns with the transmission region 756. This enables energy delivered from a source external to the drainage element 750 to pass through the transmission region 756 and impart (e.g., heat) energy to the target.
[0066] The drainage element 750 can further include a window 758. The window 758 can be composed of a transparent or translucent material that enables a user (e.g., a physician) to visualize the orientation of the actuator 701. In some embodiments, the window 758 can align with the target region of the actuator 701 and the transmission region 756 can be omitted. In embodiments where the drainage element 750 includes a substantially rigid inner structure 751 and a semi-flexible outer structure 753, the window 758 can be an opening in the semi-flexible outer structure 753 and the fluid inlet 716 can be in the substantially rigid inner structure 751.
[0067] The first actuator 701a includes a protrusion 702 (e.g., a finger, tongue, lever, gate element, control element, etc.), a first actuating element 708a, a second actuating element 708b, a first target 710a, and a second target 710b. The first actuating element 708a extends between the first target 710a and the proximal region 702a of the protrusion 702, and the second actuating element 708b extends between the second target 710b and the proximal region 702a of the protrusion 702. The protrusion 702 extends from the proximal region 702a to a distal region 702b configured to interface with and control the flow of fluid therethrough from a first fluid inlet 716a. In the illustrated embodiment, the protrusion 702 extends toward the first target 710a and the second target 710b (e.g., the distal region 702b is between the proximal region 702a and the first and second targets). In other embodiments, the protrusion 702 extends away from the first target 710a and the second target 710b (e.g., the proximal region 702a is between the distal region 702b and the first and second targets). In such embodiments, the first fluid inlet 716a is also positioned distally (e.g., closer by the first port 734a and the first channel 752a) such that the distal region 702b of the protrusion is configured to interface with the first fluid inlet 716a. Regardless of its orientation, as will be described in more detail below, the distal region 702b of the protrusion is a free end (e.g., not connected to another part of the first actuator 701a or another part of the system 700) such that it can pivot / rotate relative to the drain element 750 and the first fluid inlet 716a. In some embodiments, the first actuating element 708a and the second actuating element 708b are connected via a connector region. In such embodiments, the protrusion 702 can extend from the connector region. The connector region can be adjacent to the first actuating element 708a, the second actuating element 708b, and / or the protrusion 702, or can be a separate element coupled to the first actuating element 708a, the second actuating element 708b, and / or the protrusion 702 by suitable connection techniques.
[0068] The first actuator 701a can be fixed to or at least partially constrained with respect to the drain element 750. For example, in the illustrated embodiment, the proximal region 702a of the protrusion 702 is pivotally / rotatably fixed to the drain element 750 via a restraint 720 (e.g., an anchor, a pin, etc.) such that the protrusion 702 can pivot / rotate with respect to the drain element 750. Thus, the protrusion 702 can also be referred to as a rotary control element. In some embodiments, the proximal region 702a can include an aperture (not shown) into which the restraint 720 can be inserted to facilitate coupling the proximal region 702a to the drain element 750 via the restraint 720.
[0069] The first target 710a is fixed to the drain element 750 via a first restraint 724a (e.g., an anchor, a pin, etc.) of the first target and a corresponding first aperture 712a in the first target 710a. The first restraint 724a and the first aperture 712a of the first target are shown as being decoupled in FIG. 7B for clearer illustration of both components. However, as shown in FIG. 7C which omits other features of the system 10 for clarity and shows the first actuator 701a and the selective restraint, the first restraint 724a of the first target extends through a first aperture 712a (not visible in FIG. 7C) and is configured to fix the first target 710a to the drain element 750. Thus, fixing the first actuator 701a to the drain element 750 thus involves deforming it (e.g., stretching it) relative to its preferred or fabricated geometric shape such that the first aperture 712a is aligned with the first restraint 724a of the first target, and fixing it to the drain element using one or more pins or anchors. As will be described in more detail below, this deformation applies tension to the first actuating element 708a to prepare it to undergo geometric changes when the first target 710a is heated. The second target 710b is also fixed to the drain element 750 via a first restraint 724b of the second target and a corresponding second aperture 712b in the second target 710b. The first restraint 724b and the second aperture 712b of the second target are shown as being decoupled in FIG. 7B for clearer illustration of both components. However, as shown in FIG. 7C, the first restraint 724b of the second target is configured to extend through a second aperture 712b (not visible in FIG. 7C) to fix the second target 710b to the drain element 750.Therefore, securing the first actuator 701a to the drain element 750 thus involves deforming it (e.g., stretching it) relative to its preferred or as-fabricated geometry such that the second aperture 712b aligns with the first restraint 724b of the second target, and securing it to the drain element 750 using one or more pins or anchors. As will be described in more detail below, this deformation places tension on the second actuating element 708b to prepare it to undergo a geometric change when the second target 710b is heated.
[0070] Accordingly, in the illustrated embodiment, the first actuator 701a is anchored to the drainage element 750 at at least three locations / regions (e.g., the first target 710a, the second target 710b, and the proximal region 702a of the protrusion 702). Without being bound by theory, by anchoring the first actuator 701a to the drainage element 750 at three locations or regions, a relatively small movement of a first portion of the actuator (e.g., the first actuating element 708a) is converted, as described below, into a relatively large movement of a second portion of the actuator (e.g., the distal region 702b of the protrusion 702) via a pivotal movement, enabling the first actuator 701a to operate. By anchoring the first actuator 701a at three locations, the first target 710a and the second target 710b can also be substantially thermally isolated (as opposed to the case where the first target 710a and the second target 710b are directly connected and anchored at a single location), thereby enabling the first actuating element 708a and the second actuating element 708b to be selectively and independently actuated. In other embodiments, the first actuator 701a can be anchored to the drainage element 750 at fewer or more locations, such as one, two, four, five, six, seven, eight, or more locations. Further, although shown as being anchored by the first and second restraints 724, 726, the first and second targets 710a, 710b can be anchored by other suitable means. For example, in some embodiments, the first and second targets 710a, 710b can be connected to the inner surface of the drainage element 750 via an adhesive (e.g., glue, tape, staples, etc.).
[0071] As best shown in FIG. 7C, the first target 710a can also be at least partially constrained by a second restraint 726a of the first target, and the second target 710b can also be at least partially constrained by a second restraint 726b of the second target. The second restraint 726a of the first target does not necessarily directly couple the first actuator 701a to the drain element 750; rather, it reduces or prevents the first target 710a and / or the second actuating element 708a from rotating or bending inwardly toward the protrusion 702. Similarly, the second restraint 726b of the second target does not necessarily directly couple the first actuator 701a to the drain element 750; rather, it reduces or prevents the second target 710b from rotating or bending inwardly toward the protrusion 702.
[0072] In some embodiments, the first actuating element 708a can optionally be at least partially constrained by a restraint 728a of the first actuating element, and the second actuating element 708b can optionally be at least partially constrained by a restraint 728b of the second actuating element. Similar to the second restraint 726a of the first target, the restraint 728a of the first actuating element does not necessarily directly couple the first actuating element 708a to the drain element 750, but nevertheless can prevent or reduce the first actuating element 708a from bending or moving inwardly towards the protrusion 702. Similarly, the restraint 728b of the second actuating element does not necessarily directly couple the second actuating element 708b to the drain element 750, but nevertheless can prevent or reduce the second actuating element 708b from bending or moving inwardly towards the protrusion 702. As a result of the restraint 728a of the first actuating element, the first actuating element 708a includes a first (e.g., substantially linear) region 708a1 extending from the first target 710a and a second (e.g., non-linear or curved region) 708a2 extending between the first region 708a1 and the protrusion 702. Similarly, as a result of the restraint 728b of the second actuating element, the second actuating element 708b includes a first (e.g., substantially linear) region 708b1 extending from the second target 710b and a second (e.g., non-linear or curved region) region 708b2 extending between the first region 708b1 and the protrusion 702. The first actuating element 708a and the second actuating element 708b can also be at least partially constrained by a wall 730 shown in FIG. 7B (e.g., preventing outward bending or curving of the first region 708a1 and the first region 708b1). By at least partially constraining the actuating element 708 from bending inwardly or outwardly in the first regions 708a1, 708b1, more strain within the actuator 701a is converted into a greater displacement of the protrusion 702 during operation of the first actuator 701a, as described below.
[0073] The first actuating element 708a and the second actuating element 708b generally act in opposition. For example, as described in more detail below, actuating the first actuating element 708a rotates the protrusion 702 in a first direction (e.g., clockwise), changing (e.g., decreasing) the fluid resistance through the first fluid inlet 716a (e.g., by unblocking, at least partially unblocking, or further unblocking the first fluid inlet 716a). The second actuating element 708b actuates the protrusion 702 to rotate in a second direction generally opposite the first direction (e.g., counterclockwise), changing (e.g., increasing) the fluid resistance through the first fluid inlet 716b (e.g., by blocking, further blocking, and / or interfering with the first fluid inlet 716a).
[0074] To facilitate the aforementioned movement of the protrusion 702, the first actuator 701a can be at least partially composed of a shape memory material or alloy (e.g., nitinol). Thus, the first actuator 701a (and / or selected regions thereof) can be transitionable between at least a first material phase or state (e.g., martensite state, R-phase, composite state between martensite and R-phase, etc.) and a second material phase or state (e.g., austenite state, R-phase state, composite state between austenite and R-phase, etc.). In the first material state, the first actuator 701a or selected regions thereof can be deformable (e.g., plastic, malleable, compressible, expandable, etc.). In the second material state, the first actuator 701a or selected regions thereof can have a preferential tendency towards a particular preferred geometric shape (e.g., original geometric shape, manufactured or fabricated geometric shape, heat-set geometric shape, etc.). As described in more detail below, selected regions of the first actuator 701a can be transitioned between the first and second material states by applying energy (e.g., heat) to the first actuator 701a to heat the assembly above the transition temperature. In some embodiments, the transition temperature is a temperature higher than the average body temperature (e.g., average temperature of the human eye).
[0075] In some embodiments, the first actuating element 708a and the second actuating element 708b of the first actuator 701a can be actuated selectively and independently (e.g., transitioned between a first material state and a second material state). For example, to actuate the first actuating element 708a, heat / energy can be applied to the first target 710a from an energy source (e.g., a laser) positioned external to the patient's eye. The heat applied to the first target 710a spreads through at least a portion of the first actuating element 708a and can heat the first actuating element 708a above its transition temperature. To actuate the second actuating element 708b, heat / energy can be applied to the second target 710b. The heat applied to the second target 710b spreads through the second actuating element 708b and can heat at least a portion of the second actuating element 708b above its transition temperature.
[0076] Figures 7D and 7E respectively show the first actuator 701a after the actuation of the first actuating element 708a and the second actuating element 708b. When the first actuating element 708a is deformed with respect to its preferred geometric shape (e.g., as shown in Figure 7B), by actuating the first actuating element 708a, the first actuating element 708a moves towards its preferred geometric shape. For example, when the first actuating element 708a is stretched (e.g., tension is applied) with respect to its preferred geometric shape, by actuating the first actuating element 708a, the first actuating element 708a contracts (e.g., shortens). The contraction of the first actuating element 708a generally occurs in the second non-linear region 708a2. This is because the first substantially linear region 708a1 is held in place via one or more restraints (e.g., the restraint 728a of the first actuating element). Further, since the first actuator 701a is rotatably coupled to the drain element 750 by the restraint 720, by contracting the first actuating element 708a, a rotational movement is induced in the protrusion 702. In particular, the distal region 702b of the protrusion 702 is rotated clockwise (as indicated by the arrow A) towards the second actuating element 708b. Thereby, the protrusion 702 can move from a first position providing a first fluid resistance via the first fluid inlet 716a to a second position providing a second fluid resistance smaller than the first fluid resistance via the first fluid inlet 716b and / or towards that second position. For example, the protrusion 702 may block or substantially block the first fluid inlet 716a in the first position and may unblock or at least partially unblock the first fluid inlet 716a in the second position. Following the actuation of the first actuating element 708a, the protrusion 702 may react at least slightly towards the first position (e.g., rotate in the counterclockwise direction), but nevertheless remains rotated downward with respect to the first position such that the first fluid inlet 716a remains at least partially unblocked. In other embodiments, the protrusion 702 remains in the second position without showing a substantial reaction.In addition to moving the protrusion 702 towards the second actuating element 708b, actuating the first actuating element 708a can also induce a deformation (e.g., stretching, elongation, tension, etc.) corresponding to the second actuating element 708b, which remains in the first material state and thus becomes substantially malleable (e.g., by actuating the first actuating element 708a, the strain of the first actuating element 708a decreases and the strain of the second actuating element 708b increases).
[0077] As shown in FIG. 7E, the operation can be reversed by actuating the second actuating element 708b to contract (e.g., shorten) the second actuating element 708b towards its preferred geometric shape. The contraction of the second actuating element 708b mainly occurs in the second non-linear region 708b2. This is because the first substantially linear region 708b1 is held in place via one or more restraints (e.g., the restraint 728b of the second actuating element). Since the first actuator 701a is rotatably fixed by the restraint 720, rotating the second actuating element 708b induces a rotational movement in the projection 702. In particular, the distal region 702b of the projection 702 is rotated in a counterclockwise direction towards the first actuating element 708a (as shown by arrow B). Thereby, the projection 702 can move from a second position providing a second relatively lower fluid resistance via the first fluid inlet 716a to a first position providing a first relatively higher fluid resistance via the first fluid inlet 716a and / or towards that position. In some embodiments, the projection 702 can rotate counterclockwise to a third position between the first fluid inlet 716a and the first actuating element 708a when the second actuating element 708b is actuated. Thus, in some embodiments, the system 10 includes a mechanical or other stop mechanism configured to prevent the projection 702 from rotating excessively in the counterclockwise direction, whereby the projection 702 may not block the first fluid inlet 716a during actuation of the second target 710b. The mechanical stop can be configured to stop the counterclockwise rotation of the projection 702 when the projection 702 blocks or substantially blocks the first fluid inlet 716a following actuation of the second actuating element 708b.
[0078] Accordingly, the first actuating element 708a and the second actuating element 708b can be selectively and independently actuated to block or unblock the first fluid inlet 716a and control the flow of fluid therethrough. In some embodiments, the protrusion 702 can move to any number of positions between fully blocking and fully unblocking the first fluid inlet 716a to provide various different outflow resistance levels by gradually adjusting the protrusion 702 relative to the first fluid inlet 716a. Further details regarding the operation of the shape memory actuator are described in U.S. Patent Application No. 2020 / 0229982 and International Patent Applications No. PCT / US20 / 55144 and PCT / US20 / 55141, the disclosures of which are incorporated herein by reference in their entirety.
[0079] In some embodiments, the first actuator 701a can be of an integral or unitary construction (e.g., fabricated from a single piece of material, fabricated using a vapor deposition process, etc.). To assemble the fluid control assembly 700, the first actuator 701a can be tensioned (e.g., stretched, elongated, expanded, etc.) via a restraint while in a first material state and secured to the drain element 750. This causes the actuating elements 708 to be at least partially deformed relative to their preferred geometric shapes. For example, as described above, both the first actuating element 708a and the second actuating element 708b are stretched (e.g., elongated) relative to their preferred geometric shapes when loaded into the drain element 750. In other embodiments, the first actuator 701a can be compressed rather than tensioned and secured to the drain element 750.
[0080] The foregoing description has been directed to the first actuator 701a, but the description can also apply to the second actuator 701b and / or the third actuator 701c. Thus, the second actuator 701b and / or the third actuator 701c can be the same as, or at least substantially similar to, the first actuator 701a. Thus, the drainage of water through the system 10 can be selectively controlled by selectively blocking and / or unblocking the fluid inlet 716 using the actuator 701. For example, to provide a first level of treatment having a first drainage rate and a first flow resistance, the first fluid inlet 716a can be made accessible / unblocked, while the second fluid inlet 716b and the third fluid inlet 716c remain inaccessible / blocked. To provide a second level of treatment having a second drainage rate greater than the first drainage rate (e.g., a second flow resistance less than the first flow resistance), the second fluid inlet 716b can be made accessible / unblocked, while the first fluid inlet 716a and the third fluid inlet 716c remain inaccessible / blocked. To provide a third level of treatment having a third drainage rate greater than the second drainage rate (e.g., a third flow resistance less than the first flow resistance), the first fluid inlet 716a and the second fluid inlet 716b can be unblocked, while the third fluid inlet 716c remains blocked. As will be appreciated by those skilled in the art, the flow control assembly 700 can be operative such that any combination of the first fluid inlet 716a, the second fluid inlet 716b, and the third fluid inlet 716c is blocked or unblocked to provide at least eight different treatment levels (ranging from a state where all three fluid inlets are blocked to a state where all three fluid inlets are unblocked).
[0081] In some embodiments, the resistance provided by each of the individual channels 752 can have a predetermined ratio. For example, when the third fluid inlet 716c is unblocked, the ratio of the resistance provided by the third channel 752c, when the second fluid inlet 716b is unblocked, the resistance provided by the second channel 752b, and when the first fluid inlet 716a is unblocked, the resistance provided by the first channel is 1:2:4. In some embodiments, for a given pressure, the flow rate through the system 10 when only the first fluid inlet 716a is unblocked can be about X, the flow rate through the system when only the second fluid inlet 716a is unblocked can be about 2X, and the flow rate through the system when only the third fluid inlet 716c is unblocked can be about 4X. In this way, the pattern of resistance (and drainage rate) that can be achieved using the system 10 can be adjusted according to known patterns. For example, the actuator 701 can be operated such that any combination of the fluid inlets 716 is blocked and unblocked, thereby providing any flow rate between X (when only the first fluid inlet 716a is unblocked) and 7X (when all fluid inlets 716 are unblocked). Additional details regarding the ability to provide multiple treatment levels using an intraocular shunt system having various fluid inlets are described in International Patent Application No. PCT / US21 / 14774, the disclosure of which is incorporated herein by reference in its entirety.
[0082] In some embodiments, the treatment level (e.g., drainage rate, flow resistance, etc.) is determined by the relative dimensions of the channels 752 rather than the number or size of the fluid inlets 716. For example, as previously described, the channels 752 can have different dimensions. In some embodiments, the diameter or other cross-sectional area of the first channel 752a is smaller than the diameter or other cross-sectional area of the second channel 752b, and the second channel 752b itself is smaller than the diameter or other cross-sectional area of the third channel 752c. In embodiments where the flow resistance is determined by the channel 760, the fluid inlets 716 can, nevertheless, include a different number of apertures to provide a visual cue to the healthcare provider that reflects the relative fluid resistance of the corresponding channel. (For example, one aperture means that the corresponding fluid channel has a first resistance, two apertures mean that the corresponding fluid channel has a second resistance that is smaller than the first resistance, etc.). In other embodiments, the fluid inlets 716 can include another visual cue or indicator that reflects the relative fluid resistance of the corresponding channel.
[0083] Without being bound by theory, it is expected that using a rotational / pivoting motion to selectively block and / or unblock the fluid inlet 716 provides several advantages compared to an actuator that operates via linear motion. For example, a relatively small motion of the actuating element 708 can be converted into a relatively large motion of the distal region 702b of the protrusion 702. Without being bound by theory, this is expected to reduce the amount of strain required in the first and second actuating elements 708 to move the protrusion 702 (e.g., to block and / or unblock the fluid inlet 716). Next, this can further enhance the consistency of the motion of the protrusion 702 compared to an actuator having an actuating element arranged in a linear shape.
[0084] Figures 8A-8C show an intraocular shunt system 20 (the "system 20") constructed in accordance with selected embodiments of the present technology. More specifically, FIG. 8A is a front view of the system 20, FIG. 8B is a side view of the system 20, and FIG. 8C is an enlarged front view of the flow control assembly 800 of the system 20 taken along the line shown in FIG. 8A. The system 20 can be substantially similar to the system 10 described with respect to FIGS. 7A-7E. For example, referring to FIG. 8A, the system 20 can include a drainage element 850 and a flow control assembly 800. The drainage element 850 can extend between a first end portion 850a and a second end portion 850b and can have a generally flat outer shape. The drainage element 850 can further include one or more channels 852 that extend between the first end portion 850a and the second end portion 850b. When implanted into a patient's eye, the first end portion 850a can be at least partially within the internal region of the eye (e.g., the anterior chamber), and the second end portion 850b can be at least partially within and / or in fluid communication with a desired outflow location (e.g., the subconjunctival bleb space). The drainage element 850 can optionally include one or more wings or appendages 860 having holes (e.g., suture holes) for securing the drainage element 850 in a desired position. As best shown in FIG. 8B, the drainage element 850 can have a generally curved outer shape to better conform to the anatomical structure of the eye.
[0085] Referring to FIG. 8C, the flow control assembly 800 can include a first actuator 801a and a second actuator 801b (collectively referred to as "actuator 801"). The actuator 801 can be substantially similar to the actuator 701 described with respect to FIGS. 7A-7E. For example, the first actuator 801a includes a protrusion 802 (e.g., a finger, a tongue, a lever, a gate element, a control element, etc.), a first actuating element 808a, a second actuating element 808b, a first target 810a, and a second target 810b. The first actuator 801a can be constrained and / or fixed to the drain element 850 via a first restraint 820, a second restraint 822, and a third restraint 824. The protrusion 802 can rotate / pivot about the first restraint 820 as previously described with respect to FIGS. 7A-7E. However, unlike the actuator 701, the first actuator 801a can also rotate / pivot about the second restraint 822 and the third restraint 824. Thus, the actuator 801 can rotate in three locations (e.g., the first actuator 801a has three rotational degrees of freedom).
[0086] Figures 9A - 9D are for controlling the flow of fluid within the shunt system and illustrate an actuator 901 constructed in accordance with a selected embodiment of the present technology. More specifically, FIG. 9A is an isometric view of the actuator 901, FIG. 9B is a top view of the actuator 901 in a fabricated or un-tensioned configuration, FIG. 9C is a top view of the actuator 901 in a tensioned configuration, and FIG. 9D is a top view of the actuator 901 in an operating configuration. For clarity, the actuator 901 is shown separately. However, as will be understood by those skilled in the art, the actuator 901 can be used in a system similar to system 10 or system 20 described with reference to FIGS. 7A - 7E and FIGS. 8A - 8C respectively (e.g., as an alternative to actuators 701 and 801 respectively). Further, the actuator 901 can operate in a manner substantially similar to the previously described actuators 701 (FIGS. 7A - 7E) and actuator 801 (FIGS. 8A - 8C). Accordingly, the following description will focus particularly on the features and functions of the actuator 901 that are different from those previously described.
[0087] Referring initially to FIG. 9A, actuator 901 includes a protrusion 902, a first actuating element 908a, and a second actuating element 908b (collectively referred to as "actuating elements 908"). During operation, the actuating elements 908 are selectively and independently actuated, as previously described herein, to rotate the protrusion 902 to block (e.g., interfere with, partially interfere with, etc.) or unblock (e.g., open, avoid, etc.) a fluid inlet (e.g., fluid inlet 716 of system 10 shown in FIG. 7A) through which fluid flows. The protrusion 902 can include selected features that increase the efficiency and / or flow control provided by the actuator 901 in at least some embodiments. For example, the protrusion 902 can include a blocking mechanism 905 positioned in its distal region 902b. The blocking mechanism 905 can increase the surface area or volume such that when in the "closed" position, the protrusion 902 interfaces better with one or more fluid inlets (e.g., fluid inlet 716 of system 10) to control the flow of fluid therethrough. Nevertheless, the blocking mechanism 905 can be configured to allow fluid flow through one or more fluid inlets when in the "open" position. The protrusion 902 can also have a neck region 903 in its proximal region 902a that has a thinner cross-section than other portions of the protrusion 902. Strain induced by the protrusion 902 contacting another part of the actuator 901 during operation can be preferentially minimized by the neck region 903 rather than concentrated in other parts of the actuator 901 (e.g., the actuating elements 908). This is expected to improve the reproducibility and consistency of the motion that can be induced during operation of the actuator 901.
[0088] The actuator 901 also includes a first target 910a and a second target 910b (collectively referred to as the "target 910") for receiving energy to power the actuating element 908. Unlike the actuator described with respect to FIGS. 7A - 8C, the targets 910 of the actuator 901 are positioned along their respective actuating elements 908. In particular, the first target 910a is positioned on the first actuating element 908a so as to divide the first actuating element 908a into a first portion 908a1 and a second portion 908a2. Similarly, the second target 910b is positioned on the second actuating element 908b so as to divide the second actuating element 908b into a first portion 908b1 and a second portion 908b2. The energy received by the first target 910a can spread to both the first portion 908a1 and the second portion 908a2 of the first actuating element 908a, and the energy received by the second target 910b can spread to both the first portion 908b1 and the second portion 908b2 of the second actuating element 908b. Without being bound by theory, it is thus expected that by placing the targets 910 along the actuating elements 908, the energy received by the targets 910 can be spread more quickly and / or efficiently to the corresponding actuating elements 908 to drive their operation (e.g., by reducing heat dissipation losses within the actuating elements 908).
[0089] The actuator 901 further includes a first aperture 911a and a second aperture 911b for fixing the actuator 901 to a drain element, a plate, or other structure (e.g., the drain element 750 of the system 10 shown in FIG. 7A). For example, the first aperture 911a can be configured to receive a first pin or other anchor element, and the second aperture 911b can be configured to receive a second pin or other anchor element. Thus, the actuator 901 can be fixed to the drain element or other shunt structure at two locations. In some embodiments, as previously described with respect to the actuator 701 of FIGS. 7A-7E, the actuator 901 is configured to be rotatably fixed to the drain element or other shunt structure at least in the first aperture 911a such that the protrusion 902 can rotate when the actuating element 908 is actuated.
[0090] Actuator 901 can be manufactured and operated in a manner substantially similar to that described for actuators 701 and 801. For example, FIG. 9B shows actuator 901 in a fabricated or non-tensioned position having a first length L1. Actuator 901 can be fabricated from a single or continuous piece of material (e.g., nitinol), as previously described with respect to FIGS. 7A-7E. Once fabricated, actuator 901 can be manipulated into different tension configurations before / while being fixed to a shunt or other structure (e.g., actuator 901 can be manipulated such that first aperture 911a and second aperture 911b are aligned with and engage pins extending from a drain element or other shunt structure). FIG. 9C shows actuator 901 in a tensioned configuration that has been stretched or otherwise extended relative to the fabricated position such that it has a second length L2 that is greater than the first length L1. In other embodiments, actuator 901 can be compressed relative to the fabricated configuration to form a tensioned configuration where L2 can be less than L1. At the tensioned position shown in FIG. 9C, both the first actuating element 908a and the second actuating element 908b are extended relative to their preferred (e.g., fabricated) geometric shapes. Thus, as previously described with respect to FIGS. 7A-7E, the first actuating element 908a and the second actuating element 908b can be selectively actuated by applying energy to first target 910a or second target 910b, respectively, to rotate projection 902 to block or unblock a fluid inlet of a shunt structure (not shown). For example, FIG. 9D shows actuator 901 after actuation of the second actuating element 908b. Since the second actuating element 908b is extended relative to its preferred (e.g., fabricated) geometric shape, heating at least a portion of the second actuating element 908b above its transition temperature induces a phase change in the material of the second actuating element 908b, causing the second actuating element 908b to contract towards its preferred (e.g., fabricated) geometric shape. This causes the distal region 902b of projection 902 to rotate upwardly.This movement can be reversed by heating at least a portion of the first actuating element 908a above its transition temperature to induce a phase change in the material therein, contracting the first actuating element 908a towards its preferred (e.g., fabricated) geometric shape, and rotating the protrusion 902 downwardly.
[0091] Figures 10A - 10D illustrate another actuator 1001 that is for controlling the flow of fluid within a shunt system and is configured in accordance with a selected embodiment of the present technology. More specifically, FIG. 10A is an isometric view of the actuator 1001, FIG. 10B is a top view of the actuator 1001 in its fabricated or non - stressed configuration, FIG. 10C is a top view of the actuator 1001 in its tensioned configuration, and FIG. 10D is a top view of the actuator 1001 in its actuated configuration. For clarity, the actuator 1001 is shown separately. However, as will be understood by those skilled in the art, the actuator 1001 can be used in a system similar to system 10 or system 20 described with reference to FIGS. 7A - 7E and FIGS. 8A - 8C respectively (e.g., as an alternative to actuators 701 and 801 respectively). Further, the actuator 1001 can operate in a manner substantially similar to the previously described actuators 701 (FIGS. 7A - 7E), actuator 801 (FIGS. 8A - 8C), and / or actuator 901 (FIGS. 9A - 9D). Accordingly, the following description will focus particularly on the features and functions of the actuator 1001 that are different from those previously described.
[0092] Referring initially to FIG. 10A, actuator 1001 includes a projection 1002, a first actuating element 1008a, and a second actuating element 1008b (collectively referred to herein as "actuating elements 1008"). During operation, the actuating elements 1008 are selectively and independently actuated, as described earlier herein, to rotate the projection 1002 and block or unblock a fluid inlet (e.g., fluid inlet 716 of system 10 shown in FIG. 7A) to control the flow of fluid therethrough. Actuator 1001 also includes a first target 1010a and a second target 1010b (collectively referred to herein as "targets 1010") for receiving energy and powering the actuator. Similar to actuator 901 of FIGS. 9A-9D, the targets 1010 of actuator 1001 are positioned along respective actuating elements 1008 to facilitate more rapid and / or more efficient heating of the actuating elements 1008 when energy is applied to the respective targets 1010.
[0093] Actuator 1001 further includes a first aperture 1011a, a second aperture 1011b, and a third aperture 1011c for fixing the actuator 1001 to a drain element, a plate, or other structure (e.g., the drain element 750 of the system 10 shown in FIG. 7A). Thus, the actuator 1001 can be fixed to the drain element or other shunt structure at at least three locations. In some embodiments, as previously described with respect to the actuator 701 of FIGS. 7A-7E, the actuator 1001 is configured to be rotatably fixed to the drain element or other shunt structure at least in the first aperture 1011a such that the protrusion 1002 can rotate when the actuating element 1008 is actuated. In some embodiments, the actuator 1001 is also configured to be rotatably fixed to the drain element or other shunt structure in the second aperture 1011b and the third aperture 1011c, while in other embodiments, the actuator 1001 is configured to be fixedly fixed to the drain element in the second aperture 1011b and / or the third aperture 1011c. Thus, the actuator 1001 can have 1 to 3 degrees of rotational freedom.
[0094] Actuator 1001 can be manufactured and operated in a manner substantially similar to that described previously. FIG. 10B shows actuator 1001 in a fabricated or non-tensioned position where actuator 1001 has a first length L1. Actuator 1001 can be fabricated from a single or continuous piece of material (e.g., nitinol) as previously described with respect to FIGS. 7A - 7E. Once fabricated, actuator 1001 can be manipulated into different tension configurations before / while being fixed to a shunt or other structure (e.g., actuator 100 can be manipulated such that first aperture 1011a, second aperture 1011b, and third aperture 1011c are aligned with and engage pins extending from a plate or other drainage element). FIG. 10C shows actuator 1001 in a tensioned configuration where it is stretched or otherwise extended relative to the fabricated position such that it has a second length L2 that is greater than the first length L1. In other embodiments, actuator 1001 can be compressed relative to the fabricated configuration to form a tensioned configuration where L2 can be less than L1. At the tensioned position shown in FIG. 10C, both the first actuating element 1008a and the second actuating element 1008b are extended relative to their preferred (e.g., fabricated) geometric shapes. Thus, as previously described with respect to FIGS. 7A - 7E, the first actuating element 1008a and the second actuating element 1008b can be selectively actuated by applying energy to the first target 1010a or the second target 1010b respectively to rotate the protrusion 1002 and block or unblock the fluid inlet of a shunt structure (not shown). For example, FIG. 10D shows actuator 1001 after actuation of the first actuating element 1008a. Since the first actuating element 1008a is extended relative to its preferred geometric shape, heating at least a portion of the first actuating element 1008a above its transition temperature induces a phase change in the material within the first actuating element 1008a and causes the first actuating element 1008a to contract towards its preferred geometric shape. This causes the distal region 1002b of the protrusion 1002 to rotate downwardly.This movement can be reversed by heating at least a portion of the second actuating element 1008b above its transition temperature to induce a phase change in the material therein, causing the second actuating element 1008b to contract towards its preferred geometric shape, and rotating the projection 1002 upward.
[0095] As shown in FIG. 10D, by actuating one of the actuating elements 1008, the first end portion region 1001a and the second end portion region 1001b of the actuator 1001 can bend or flare inward. This can be reduced or prevented by preventing rotation at the second aperture 1011b and the third aperture 1011c (e.g., by preventing rotation about a pin used to secure the actuator 1001 to a drain element, plate, or other shunt structure), and / or by using one or more restraints similar to the second restraint 726a of the first target and the second restraint 726b of the second target shown in FIGS. 7B and 7C. Without being bound by theory, it is expected that preventing rotation at the first end portion region 1001a and the second end portion region 1001b will generate a greater displacement of the projection 1002 and / or increase the strain within the unrestrained portion of the actuator 1001.
[0096] Figures 11A - 11D show another actuator 1101 for controlling the flow of fluid within a shunt system and constructed in accordance with a selected embodiment of the present technology. More specifically, FIG. 11A is an isometric view of actuator 1101 in a fabricated or non - tensioned configuration, FIG. 11B is a top view of actuator 1101 in a fabricated or non - tensioned configuration, FIG. 11C is a top view of actuator 1101 in a tensioned configuration, and FIG. 11D is a top view of actuator 1101 in an actuated configuration. For clarity, actuator 1101 is shown separately. However, as will be understood by those skilled in the art, actuator 1101 can be used in a system similar to system 10 or system 20 described with reference to FIGS. 7A - 7E and FIGS. 8A - 8C respectively (e.g., as an alternative to actuators 701 and 801 respectively). Further, actuator 1101 can operate in a manner substantially similar to actuator 701 (FIGS. 7A - 7E), actuator 801 (FIGS. 8A - 8C), actuator 901 (FIGS. 9A - 9D), and / or actuator 1001 (FIGS. 10A - 10D) described previously. Accordingly, the following description will focus particularly on the features and functions of actuator 1101 that are different from those previously described.
[0097] Unlike actuators 701, 801, 901, and 1001, actuator 1101 can be fixed to itself and transformed from the fabricated configuration to a tension configuration. For example, referring to FIGS. 11A and 11B showing actuator 1101 in the fabricated configuration, actuator 1101 includes a first arm 1113a and a second arm 1113b that extend generally parallel to a first actuating element 1108a and a second actuating element 1108b, respectively. A first appendage 1115a extends transversely inwardly from the first arm 1113a towards the second arm 1113b, and a second appendage 1115b extends transversely inwardly from the second arm 1113b towards the first arm 1113a. Actuator 1101 further includes an anchor element 1111 that extends in a direction generally opposite to that of protrusion 1102. In the fabricated configuration, the anchor element 1111 is on the same side of the first and second appendages 1115 as the protrusion 1102 and the actuating elements 1108. To fix actuator 1101 in the tension configuration as shown in FIG. 11C, the anchor element 1111 can be stretched and positioned on the side of the first and second appendages 1115 opposite to the protrusion 1102 and the actuating elements 1108. As shown, the appendage 1115 interferes with the anchor element 1111, preventing the anchor element 1111 (and thus the actuating element 1108) from returning to the fabricated configuration. This deforms (e.g., elongates) the actuating elements 1108 relative to their preferred (e.g., fabricated) geometric shapes, whereby they can be selectively actuated by heating them above their transition temperature as described above. Thus, actuator 1101 does not require pins or other fastening elements to fix actuator 1101 in the tension configuration. In some embodiments, the anchor element 1111 can optionally be fixed to the appendage 1115 following tensioning of actuator 1101. This can be done by adhesion (e.g., welding, adhesives, etc.). FIGS. 11C and 11D show the anchor element 1111 overlapping the appendage 1115, but generally the anchor element 1111 will not overlap the appendage 1115.
[0098] When fixed in a tension configuration, actuator 1101 can operate in a manner substantially similar to that described for actuator 701. For example, first actuating element 1108a and second actuating element 1108b can selectively actuate by applying energy to first target 1110a or second target 1110b, respectively, to rotate projection 1102 and block or unblock a fluid inlet of a shunt structure (not shown). For example, FIG. 11D shows actuator 1101 after actuation of first actuating element 1108a. Since first actuating element 1108a is extended relative to its preferred geometry, by heating at least a portion of first actuating element 1108a above its transition temperature, a phase change of the material in first actuating element 1108a is induced, causing first actuating element 1108a to contract towards its preferred geometry. Thereby, distal region 1102b of projection 1102 rotates downward. This movement can be reversed by heating at least a portion of second actuating element 1108b above its transition temperature to induce a phase change of the material therein and cause second actuating element 1108b to contract towards its preferred geometry, rotating projection 1102 upward.
[0099] In some embodiments, since arm 1113 is not restricted by other aspects of the shunt system (e.g., system 10 shown in FIG. 7A), it bends slightly outward during operation of actuator 1101. In other embodiments, arm 1113 can be restricted by one or more features of the shunt system to prevent arm 1113 from bending outward during operation of actuator 1101. By preventing arm 1113 from bending outward, more energy is shifted to actuating element 1108, thereby allowing for a greater displacement of projection 1102. Thus, arm 1113 can optionally be constrained to create a tuning mechanism for adjusting the range of motion of projection 1102.
[0100] Figures 12A - 12D illustrate yet another actuator 1201 that is for controlling fluid flow within the shunt system and is configured in accordance with a selected embodiment of the present technology. More specifically, FIG. 12A is an isometric view of actuator 1201 in a fabricated or non - tensioned configuration, FIG. 12B is a top view of actuator 1201 in a fabricated or non - tensioned configuration, FIG. 12C is a top view of actuator 1201 in a tensioned configuration, and FIG. 12D is a top view of actuator 1201 in an actuated configuration. For clarity, actuator 1201 is shown separately. However, as will be understood by those skilled in the art, actuator 1201 can be used in a system similar to system 10 or system 20 described with reference to FIGS. 7A - 7E and FIGS. 8A - 8C respectively (e.g., in place of actuators 701 and 801 respectively). Further, actuator 1101 can operate in a manner substantially similar to actuator 701 (FIGS. 7A - 7E), actuator 801 (FIGS. 8A - 8C), actuator 901 (FIGS. 9A - 9D), actuator 1001 (FIGS. 10A - 10D), and / or actuator 1101 (FIGS. 11A - 11D) described previously. Accordingly, the following description will focus particularly on the features and functions of actuator 1201 that are different from those previously described.
[0101] Similar to actuator 1101, actuator 1201 can be fixed to itself and transferred from the fabricated configuration to the tension configuration. Referring to FIGS. 12A and 12B showing actuator 1201 in the fabricated configuration, actuator 1201 includes a first arm 1213a and a second arm 1213b that extend substantially parallel to a first actuating element 1208a and a second actuating element 1208b, respectively. Actuator 1101 further includes an anchor element 1111 that extends in a direction substantially opposite to that of protrusion 1102. Actuator 1201 has the first arm 1213a coupled to the second arm 1213b and further includes a bridge element 1215 that surrounds the anchor element 1111, protrusion 1202, first actuating element 1208a, and second actuating element 1208b. To fix actuator 1201 in the tension configuration as shown in FIG. 12C, the anchor element 1211 can be fixed to the bridge 1215, thereby deforming (e.g., stretching) the first actuating element 1208a and the second actuating element 1208b relative to their preferred (e.g., fabricated) geometric shapes. The anchor element 1211 can be fixed to the bridge 1215 via a locking mechanism or other suitable adhesion techniques (e.g., welding, stitching, gluing, taping, etc.). In some embodiments, the bridge 1215 may include a recess configured to receive and secure the anchor element 1211.
[0102] When fixed in a tension configuration, actuator 1201 can operate in a manner substantially similar to that described for actuator 701. For example, first actuating element 1208a and second actuating element 1208b can be selectively actuated by applying energy to first target 1210a or second target 1210b, respectively, to rotate projection 1202 and block or unblock a fluid inlet of a shunt structure (not shown). For example, FIG. 12D shows actuator 1201 after actuation of first actuating element 1208a. Since first actuating element 1208a is extended relative to its preferred geometry, by heating at least a portion of first actuating element 1208a above its transition temperature, a phase change of the material in first actuating element 1208a is induced, causing first actuating element 1208a to contract toward its preferred geometry. As a result, distal region 1202b of projection 1202 rotates downward. This movement can be reversed by heating at least a portion of second actuating element 1208b above its transition temperature to induce a phase change of the material therein and cause second actuating element 1208b to contract toward its preferred geometry, rotating projection 1202 upward. As described above with respect to FIG. 11D, arm 1213 can optionally be constrained to reduce outward bending during operation and / or tune the operation of actuator 1201 when actuator 1301 is positioned within a shunt system (e.g., system 10).
[0103] Figures 13A - 13D illustrate yet another actuator 1301 that is for controlling fluid flow within a shunt system and is configured in accordance with a selected embodiment of the present technology. More specifically, FIG. 13A is an isometric view of actuator 1301 in a fabricated or non - tensioned configuration, FIG. 13B is a top view of actuator 1301 in a fabricated or non - tensioned configuration, FIG. 13C is a top view of actuator 1301 in a tensioned configuration, and FIG. 13D is a top view of actuator 1301 in an actuated configuration. For clarity, actuator 1301 is shown separately. However, as will be understood by those skilled in the art, actuator 1301 can be used in a system similar to system 10 or system 20 described with reference to FIGS. 7A - 7E and FIGS. 8A - 8C respectively (e.g., in place of actuators 701 and 801 respectively). Further, actuator 1101 can operate in substantially the same manner as the previously described actuators 701 (FIGS. 7A - 7E), actuator 801 (FIGS. 8A - 8C), actuator 901 (FIGS. 9A - 9D), actuator 1001 (FIGS. 10A - 10D), actuator 1101 (FIGS. 11A - 11D), and / or actuator 1201 (FIGS. 12A - 12D). Accordingly, the following description will focus particularly on the features and functions of actuator 1301 that are different from those previously described.
[0104] Actuator 1301 includes a first arm 1313a and a second arm 1313b that extend generally parallel to a first actuating element 1308a and a second actuating element 1308b, respectively. Actuator 1301 also includes an anchor element 1315 having an aperture 1311 therethrough. To fixedly tension-configure actuator 1301 to a drain element, plate, or other shunt structure (not shown), anchor element 1315 can be secured to the drain element via one or more pins inserted into aperture 1311. This can include deforming actuator 1301 relative to its as-fabricated configuration to assume a tension configuration (shown in FIG. 13C). Actuator 1301 can maintain its tension configuration by free end regions 1313a1 and 1313b1 of first and second arms 1313a, 1313b that engage one or more features on the drain element. Once fixedly tension-configured, actuator 1301 can operate in a manner generally similar to that described for other actuators herein (e.g., actuator 1301 can be actuated to move projection 1302, as shown in FIG. 13D).
[0105] Figures 14A-14E illustrate a flow control assembly 1400 (“assembly 1400”) configured in accordance with a selected embodiment of the present technology for controlling fluid flow within a shunt system. More specifically, FIG. 14A is an isometric view of assembly 1400, FIG. 14B is an isometric view of a base structure 1420 of assembly 1400 with other features omitted for clarity, FIG. 14C is a bottom view of assembly 1400 in an as-fabricated or non-tension configuration, FIG. 14D is a bottom view of assembly 1400 in a loaded or tension configuration, and FIG. 14E is a bottom view of assembly 1400 in a loaded or tension configuration after being actuated relative to the configuration shown in FIG. 14D.
[0106] Referring initially to FIG. 14A, assembly 1400 includes a first actuator 1401a, a second actuator 1401b, and a base structure 1420. The first actuator 1401a and the second actuator 1401b (collectively referred to as "actuator 1401") can be coupled to the base structure 1420, which will be described in more detail below with reference to FIG. 14B. In some embodiments, assembly 1400 can be used in a system similar to system 10 or system 20 described with reference to FIGS. 7A-7E and FIGS. 8A-8C, respectively (e.g., as an alternative to actuators 701 and 801, respectively). In other embodiments, assembly 1400 can be coupled to another drainage element or shunt structure for draining fluid.
[0107] The first actuator 1401a can include a first anchor region 1404a1 and a second anchor region 1404a2. The first actuator 1401a can be coupled to the base structure 1420 at the first anchor region 1404a1 and the second anchor region 1404a2. For example, the first anchor region 1404a1 can have a first opening 1406a1 extending therethrough configured to receive a first anchor mechanism or pin 1422a1 extending from the base structure 1420. Similarly, the second anchor region 1404a2 can include a second opening 1406a2 extending therethrough configured to receive a second anchor mechanism or pin 1422a2 extending from the base structure 1420. In some embodiments, the first actuator 1401a can be alternatively or additionally coupled to the base structure 1420 via other suitable connection mechanisms such as adhesion, welding, etc. In some embodiments, the first anchor region 1404a1 and / or the second anchor region 1404a2 are rotatably / pivotally coupled to the base structure 1420 such that the first anchor region 1404a1 and / or the second anchor region 1404a2 can rotate about the first pin 1422a1 and / or the second pin 1422a2, respectively. In some embodiments, the second anchor region 1404a2 is rotatably coupled to the base structure 1420 and the first anchor region 1404a1 is fixedly coupled to the base structure (e.g., to prevent rotation of the first anchor region 1404a1 relative to the base structure 1420).
[0108] The first actuator 1401a further includes a protrusion 1402a extending from the second anchor region 1404a2. The protrusion 1402a can be or can include a finger, a tongue, a lever, a gate element, a control element, etc. The protrusion 1402a can further include an opening or aperture 1403a extending therethrough. The protrusion 1402a can be configured to control the flow of fluid through a first fluid inlet 1424a (shown in FIG. 3B) on the base structure 1420. For example, as will be described in more detail below with reference to FIGS. 14D and 14E, the protrusion 1402a has a first (e.g., open) position where the opening 1403a is at least partially aligned with the first fluid inlet 1424a (allowing fluid to flow through the first fluid inlet 1424a), and a second (e.g., closed) position where the opening 1403a is not aligned with the first fluid inlet 1424a (substantially preventing fluid from flowing through the first fluid inlet 1424a), and can move between these positions.
[0109] The first actuator 1401a further includes a first actuating element 1408a1 and a second actuating element 1408a2 (collectively referred to as the actuating element 1408a) to induce movement of the protrusion 1402. The actuating element 1408a can extend between the first anchor region 1404a1 and the second anchor region 1404a2. The actuating element 1408a can be composed of a shape memory material (e.g., nitinol) and can be actuated by a shape memory effect as described in detail previously herein. During operation, the actuating element 1408a can be selectively and independently actuated to rotate the protrusion 1402a such that the opening 1403a is at least partially aligned with the first fluid inlet 1424a, or such that the opening 1403a is not aligned with the first fluid inlet 1424a, thereby controlling the flow of fluid through the first fluid inlet 1424a.
[0110] The second actuator 1401b can be substantially similar to and / or the same as the first actuator 1401a and can be configured to control the flow of fluid through the second fluid inlet 1424b of the base structure 1420 (FIG. 14B). Further, although two actuators 1401 are shown, the assembly 1400 can have fewer or more actuators, such as one, three, four, five, six, or more actuators.
[0111] Referring now to FIG. 14B, the base structure 1420 can be a generally flat or plate-like structure having one or more retention mechanisms for securing the actuator 1401 to the base structure 1420. The retention mechanism can include a first pin 1422a1 and a second pin 1422a2 for securing the first actuator 1401a to the base structure 1420, as described above. The retention mechanism can also include a third pin 1422b1 and a fourth pin 1422b2 for securing the second actuator 1401b to the base structure 1420. Although shown as pins, the base structure 1420 can include other suitable anchors or retention mechanisms for securing the actuator 1401 thereto. As described above, the base structure 1420 also includes a first fluid inlet 1424a and a second fluid inlet 1424b. When the assembly 1400 is secured to or positioned within the drainage element, the first fluid inlet 1424a and / or the second fluid inlet 1424b can be aligned with or otherwise in fluid communication with one or more channels or lumens that transport fluid entering the drainage element through the first fluid inlet 1424a and / or the second fluid inlet 1424b to a desired outflow location.
[0112] FIG. 14C shows an actuator 1401 coupled to a base structure 1420 in a non-tension or uncoupled configuration where a first actuating element 1408a1 of a first actuator 1401a is not coupled to a first anchor region 1404a1. As shown, the first actuating element 1408a1 can include a locking mechanism 1410a (e.g., flange, lip, protrusion, key, etc.) configured to engage (e.g., releasably engage) with a retaining mechanism 1412a (e.g., groove, notch, aperture, etc.) on the first anchor region 1404a1. In other embodiments, the first anchor region 1404a1 can include the locking mechanism 1410a and the first actuating element 1408a1 can include a retaining mechanism 1412b. In yet other embodiments, a second actuating element 1408a2 can include a locking mechanism and can be disengaged from the first or second anchor region. In some embodiments, the first actuator 1401a is fabricated in a non-coupled or non-tension configuration. For example, the first actuator 1401a can be laser cut from a single piece of material such that the first actuator 1401a forms a monolithic structure.
[0113] To transfer the first actuator 1401a from the non-tension configuration shown in FIG. 14C to the tension configuration shown in FIG. 14D, the locking mechanism 1410a can be positioned within the retaining mechanism 1412a or interfaced in some other way. By positioning the locking mechanism 1410a within the retaining mechanism 1412a, at least one of the actuating elements 1408a can be deformed relative to their preferred or fabricated geometric shape. For example, by positioning the locking mechanism 1410a within the retaining mechanism 1412a, the first actuating element 1408a1 can be stretched (e.g., put under tension) relative to its preferred geometric shape and / or the second actuating element 1408a2 can be stretched (e.g., put under tension) relative to its preferred geometric shape. In some embodiments, both the first actuating element 1408a1 and the second actuating element 1408a2 are under substantially equal tension when in the tension configuration shown in FIG. 14C. As shown in FIG. 14D, in the coupled or tension configuration, the protrusion 1402a blocks the first fluid inlet 1424a (e.g., the opening 1403a is not aligned with the first fluid inlet 1424a). In use, this prevents or substantially prevents fluid from flowing through the first fluid inlet 1424a. The second actuator 1401b can be transferred between a non-tension configuration and a tension configuration in the same or a similar manner as described for the first actuator 1401a.
[0114] Actuator 1401 can be deformed into a preferred geometric shape in the tension configuration, so the movement of actuator 1401 can be induced by the shape memory effect as previously described herein for other shape memory actuators. For example, by heating the second actuating element 1408a2 above its transition temperature, a phase transformation can be induced therein and it can be moved towards its preferred geometric shape. In particular, as shown in FIG. 14E, when energy is applied to the second actuating element 1408a2, the second actuating element 1408a2 contracts towards its preferred geometric shape. Since the second actuating element 1408a2 is coupled to the second anchor region 1404a2, the contraction of the second actuating element 1408a2 causes the second anchor region 1404a2 to pivot or otherwise rotate about the second pin 1422a2 as the second pin 1422a2 contracts. Thereby, the protrusion 1402a extending from the second anchor region 1404a2 also rotates with respect to the base structure 1420. In the illustrated embodiment, the protrusion 1402a rotates clockwise with respect to the base structure 1420 during the actuation of the second actuating element 1408a2 such that the opening 1403a aligns with the first fluid inlet 1424a. In use, this enables fluid to flow through the first fluid inlet 1424a. By actuating the first actuating element 1408a1, the operation can be reversed (e.g., the first actuator 1401a can be moved to and / or towards the configuration shown in FIG. 14D). Thus, the actuating element 1408 can be selectively actuated to permit or prevent fluid from flowing through the first fluid inlet 1424a.
[0115] The protrusion 1402a is shown as having an opening 1403a that aligns with the first fluid inlet 1424a. However, in other embodiments, as detailed earlier herein, the opening 1403a may be omitted from the protrusion 1402a, and the protrusion 1402a can be easily moved between a first position that blocks (or substantially blocks) the first fluid inlet 1424a and a second position that unblocks (or substantially unblocks) the first fluid inlet 1424a. The second actuator 1401b can operate in the same or a similar manner as the first actuator 1401a to control the flow of fluid through the second fluid inlet 1424b.
[0116] Figures 15A - 15D illustrate another flow control assembly ("Assembly 1500") that is configured in accordance with a selected embodiment of the present technology and is for controlling the flow of fluid within a shunt system. More specifically, FIG. 15A is an isometric view of Assembly 1500, FIG. 15B is an enlarged perspective view of actuator 1501a of Assembly 1500, FIG. 15C is an isometric view of a variant of Assembly 1500, and FIG. 15C is a series of perspective views showing the actuating element 1508 of Assembly 1500 during operation.
[0117] Referring initially to FIG. 15A, assembly 1500 includes a first actuator 1501a, a second actuator 1501b, a third actuator 1501c, and a base structure 1520. The first actuator 1501a, the second actuator 1501b, and the third actuator 1501c (collectively referred to as "actuator 1501") can be coupled to the base structure 1520. The base structure 1520 can be, or can include, a drainage element having a central lumen 1522 extending therethrough. In some embodiments, the base structure 1520 is the first drainage element, and the assembly 1500 is configured to be used with a second drainage element or a shunt structure for draining fluid, such as those described with reference to FIGS. 7A-7E and 8A-8C (e.g., lumen 1522 drains to another drainage element). Nevertheless, the base structure 1520 can include a plurality of fluid inlets (not shown) that allow fluid to flow into the lumen 1522. As previously described herein, the actuator 1501 can control the flow of fluid through the fluid inlet to control the treatment level provided by the assembly 1500. For example, the first actuator 1501a can interface with and control the flow of fluid through the first fluid inlet, the second actuator 1501b can interface with and control the flow of fluid through the second fluid inlet, and the third actuator 1501c can interface with and control the flow of fluid through the third fluid inlet.
[0118] Next, referring to FIG. 15B, the first actuator 1501a can include a first actuating element 1508a1, a second actuating element 1508a2, and a control element 1502a generally positioned between the first actuating element 1508a1 and the second actuating element 1508a2. The control element 1502a is configured to interface with (e.g., selectively block and unblock) a fluid inlet on the base structure and control the flow of fluid therethrough. The actuating element 1508 can be at least partially composed of a shape memory material and, as previously described herein, can induce movement of the control element 1502a by a shape memory effect. In some embodiments, the actuating element 1508 can have a partial winding, nesting, S-shape, or other shape (collectively referred to as a "twist" shape) that supports some twisting of the actuating element 1508, and the amount of strain reflected in the system is captured by the action of the twist (i.e., torsion) in the structure. In some embodiments, the degree to which the actuating element 1508 is wound can be more or less than that shown in FIG. 15B.
[0119] The first actuating element 1508a1 can further include a first target mechanism 1509a1, and the second actuating element 1508a2 can further include a second target mechanism 1509a2 (collectively referred to as the "target mechanism 1509a"). The target mechanism 1509a can provide a visual target for aiming when using laser energy to operate the actuator 1501a. The first actuator 1501a further includes an outer outer periphery 1514a generally surrounding the first actuating element 1508a1 and the second actuating element 1508a2. The outer periphery 1514a can further include one or more openings 1516a for securing the first actuator 1501a to the base structure 1520.
[0120] The first actuator 1501a is shown in a non - engaged or non - tensioned configuration in FIG. 15B. In some embodiments, the first actuator 1501a is fabricated in a non - engaged or non - tensioned configuration. For example, the first actuator 1501a can be laser - cut from a single piece of material such that the first actuator 1501a forms a monolithic structure. To transfer the first actuator 1501a from a non - tensioned configuration to a tensioned configuration (not shown), the actuating element 1508 can be stretched (e.g., tensioned), and a locking mechanism 1510a at the distal end portion of the second actuating element 1508a2 can be placed within or otherwise secured to a retaining mechanism 1512a on the outer periphery 1514a. Thereby, the first actuator 1501 is fixed (e.g., releasably fixed) in a tensioned configuration. In particular, in the tensioned configuration, the first actuating element 1508a1 and the second actuating element 1508a2 deform with respect to their preferred geometric shapes. Thus, the actuating element 1508a can be selectively actuated, as previously described, via the addition of energy to its induced motion. Since the actuating element 1508a is coupled to the control element 1502a, the movement of the actuating element 1508a can induce a corresponding movement of the control element 1502a.
[0121] FIG. 15C shows a variant of the assembly 1500, with the outer periphery 1514a (FIG. 15A) of the actuating assembly omitted for clarity. In particular, in relation to the assembly 1500 shown in FIG. 15A, the control element 1502a is installed longitudinally aligned with the first actuating element 1508a1 and the second actuating element 1508a2.
[0122] FIG. 15D provides a series of schematic views depicting the actuation of the first actuating element 1508a1. In particular, FIG. 15D shows the configuration of the first actuating element 1508a1 as it transitions to and / or toward its preferred geometric shape (e.g., non-tension configuration) from a tension (e.g., stretched) configuration. The first actuating element 1508a1 has a twisted shape and is stretched relative to its preferred geometric shape, so that transitioning the first actuating element 1508a1 to and / or toward its preferred geometric shape causes the length of the first actuating element 1508a1 to decrease and it to be rotated or folded about its twist center point (which can occur at or near the first target 1509a1). This movement can drive the movement of the control element 1502a.
[0123] The second actuating element 1508a2 can operate in a manner substantially similar to the first actuating element 1508a1. However, since the control element 1502a is positioned between the actuating elements 1508, the actuation of the first actuating element 1508a1 generally moves the control element 1502a in a first direction, and the actuation of the second actuating element 1508a2 generally moves the control element 1502a in a second direction that is substantially opposite to the first direction. The second actuator 1501b and the third actuator 1501c can be substantially similar and / or the same as the first actuator 1501a. Further, although shown having three actuators 1501, the assembly 1500 can have fewer or more actuators, such as one, two, four, five, six, or more actuators.
[0124] The present technology further provides a method of manufacturing the systems and devices described herein. For example, FIG. 16 is a flowchart of a method 1600 for manufacturing an adjustable intraocular shunt system such as the systems 700 and 800 described above. Beginning at step 1602, method 1600 includes fabricating (e.g., manufacturing) an actuator at least partially composed of a shape memory material or alloy. In some embodiments, the actuator is a single or integral component composed of a shape memory material. The actuator can be fabricated by photolithography processes, deposition processes, cutting or etching of an integral structure from a sheet or source material, or other suitable techniques. Additional details regarding the fabrication of devices such as actuators via the foregoing techniques are described in U.S. Provisional Patent Application No. 63 / 039,237, the disclosure of which is incorporated herein by reference in its entirety. The actuator can be any of the actuators described herein, such as those described with respect to FIGS. 2-15D.
[0125] Method 1600 can continue by, in step 1604, deforming the actuator with respect to its fabricated and / or preferred geometric shape (e.g., to assume a tension configuration), and in step 1606, securing the deformed actuator to a drainage element, plate, or other shunt structure (e.g., drainage element 750 or drainage element 850). Deforming the actuator with respect to its fabricated geometric shape can include stretching one or more aspects of the actuator (e.g., actuating element 708) with respect to its fabricated geometric shape such that the length of one or more aspects of the actuator increases when one or more aspects are triggered to move toward their fabricated geometric shape (e.g., by an induced phase change as described above). Alternatively, deforming the actuator with respect to its fabricated geometric shape can include compressing one or more aspects of the actuator (e.g., actuating element 708) with respect to its fabricated geometric shape such that the length of one or more aspects of the actuator decreases when one or more aspects are triggered to move toward their fabricated geometric shape. In some embodiments, deforming the actuator with respect to its preferred geometric shape includes securing a first portion of the actuator to a second portion of the actuator (e.g., in the case of actuator 1101 of FIGS. 11A - 11D, positioning anchor element 1111 on first and second appendages 1115a, 1115b opposite protrusion 1102).
[0126] In step 1606, fixing the deformed actuator to the drainage element can include fixing the actuator to the drainage element at two or more locations / places. In some embodiments, as described previously, the actuator is pivotally / rotatably coupled to the drainage element at at least one of the two or more locations / places such that a portion of the actuator can pivot or otherwise rotate relative to the drainage element. The actuator can be fixed to the drainage element via any suitable mechanism such as pins, anchors, adhesives, fasteners, etc. In some embodiments, in step 1606, fixing the deformed actuator to the drainage element includes positioning the tensioned actuator within a shunt element or a chamber or other portion of the drainage element. After the actuator is fixed to the drainage element, the actuator remains at least partially deformed relative to its fabricated geometric shape such that, as described in detail previously, the actuator can be actuated using its shape memory properties.
[0127] In some embodiments, steps 1604 and 1606 can be reversed such that the actuator is fixed to the drainage element or other shunt structure and then deformed. In other embodiments, the act of fixing the actuator to the drainage element or other shunt structure causes the actuator to deform and thus steps 1604 and 1606 are performed substantially simultaneously.
[0128] The present technology further provides a method for treating a patient having glaucoma using the intraocular shunt system described herein. For example, FIG. 17 is a flowchart of a method 1700 for treating a patient having glaucoma. Beginning at step 1702, method 1700 includes implanting an intraocular shunt system into a patient's eye such that an inflow region of the shunt system (e.g., a first end portion 750a of the drainage element 750) is in fluid communication with the interior of the eye (e.g., the anterior chamber) and an outflow region of the shunt system (e.g., a second end portion 750b of the drainage element 750) is in fluid communication with a desired outflow location such as a subconjunctival bleb space. Once implanted, the shunt system can fluidly communicate the anterior chamber with the desired outflow location and can drain aqueous humor from the anterior chamber to the desired outflow location.
[0129] After implanting the shunt system, method 1700 can continue at step 1704 by heating a shape memory actuating element (e.g., the first actuating element 708a or the second actuating element 708b) to induce a rotational movement of a flow control element (e.g., the protrusion 702) that interfaces with one or more inflow ports in the inflow region. In some embodiments, heating the shape memory actuating element includes heating the actuating element above a material transition temperature such that the actuating element changes from a first material state (e.g., a martensite state, an R-phase, etc.) to a second material state (e.g., an R-phase, an austenite, etc.) via energy applied from an energy source positioned outside of the patient's body. The rotational movement of the flow control element can change the flow resistance through one or more inflow ports. For example, the rotational movement of the flow control element can further block or unblock one or more inflow ports and can make the drainage of aqueous humor through the implant system less or more.
[0130] In some embodiments, heating the shape memory actuating element induces a relatively small geometric change in the actuating element. The relatively small geometric change in the actuating element drives a rotational movement of the fluid control element. The rotational movement of the distal end of the fluid control element can be a relatively large movement relative to the geometric change of the actuating element. This can be achieved via an elongate fluid control element such as the protrusion 702 previously described with respect to FIGS. 7A - 7E.
[0131] Step 1704 can be repeated the necessary number of times to achieve the desired drainage rate and / or to reveal a change in the patient's condition. Further, steps 1702 and 1704 do not necessarily occur simultaneously and / or during the same hospital visit of the patient for treatment. Rather, step 1704 can occur days, months, or even years after the system has been implanted in the patient at step 1702. Thus, method 1700 enables a healthcare provider to adjust the level of treatment provided by the implanted intraocular system.
[0132] One of ordinary skill in the art will understand from the disclosure herein that various components of the intraocular shunt system described above can be omitted without departing from the scope of the technology. Similarly, additional components not explicitly described above can be added to the intraocular shunt system without departing from the scope of the technology. Thus, the systems described herein are not limited to the explicitly identified configurations, but rather include variations and modifications of the described systems.
[0133] Examples Some aspects of the technology are described in the following examples: 1. A system for selectively controlling fluid flow in a patient, the system comprising a drainage element having a channel extending therethrough and an aperture in fluid communication with the channel, the drainage element; An actuator coupled to a drainage element and configured to control the flow of fluid through an aperture, and, the actuator being, A control element having a first region rotatably anchored to the drainage element and a second region spaced from the first region and rotatably movable relative to the drainage element, A first actuating element coupled to the first region of the control element, the first actuating element being configured to rotate the second region of the control element in a first direction when actuated, A second actuating element coupled to the first region of the control element, the second actuating element being configured to rotate the second region of the control element in a second direction different from the first direction when actuated, a system comprising. 2. The system according to embodiment 1, wherein the control element is an elongated protrusion. 3. The system according to embodiment 1 or 2, wherein the second region of the control element interfaces with the aperture and is configured to control the flow of fluid therethrough. 4. The system according to embodiment 3, wherein the second region is movable between a first position providing a first flow resistance through the aperture and a second position providing a second flow resistance through the aperture different from the first resistance. 5. The system according to embodiment 4, wherein the control element exhibits substantially no reaction when moved from the first position to the second position. 6. A first target element configured to receive energy from an external energy source and disperse heat within the first actuating element, A second target element configured to receive energy from an external energy source and disperse heat within the second actuating element, further comprising, 22. The system according to any one of embodiments 1 to 5, wherein the first target element and the second target element can be independently energized. 7. The system according to embodiment 6, wherein the first target element is positioned at the central portion of the first actuating element, and the second target element is positioned at the central portion of the second actuating element. 8. The system according to embodiment 6 or 7, wherein the control element, the first actuating element, the second actuating element, the first target element, and the second target element form an integral structure. 9. The system according to embodiment 8, wherein the integral structure is composed of a shape memory material. 10. The system according to any one of embodiments 6 to 9, wherein the first target element and the second target element are anchored to the drainage element. 11. The system according to any one of embodiments 1 to 10, wherein the actuator is anchored to the drainage element at at least three locations. 12. The system according to any one of embodiments 1 to 11, wherein the actuator includes at least three rotational degrees of freedom with respect to the drainage element. 13. The system according to any one of embodiments 1 to 12, wherein the first actuating element and the second actuating element are composed of a shape memory material. 14. The system according to any one of embodiments 1 to 13, wherein the drainage element includes a substantially rigid inner structure that houses the actuator and a semi-flexible outer structure that at least partially encloses the substantially rigid inner structure. 15. The system according to embodiment 14, wherein the substantially rigid inner structure is a plate, the semi-flexible outer structure is a casing, and the plate forms a fluid seal with the casing to prevent fluid leakage between the plate and the casing. 16. The system according to embodiment 14 or 15, wherein the semi-flexible outer structure includes an opening, the substantially rigid inner structure includes an aperture, and the aperture is aligned with the opening. 17. The channel is the first channel, the aperture is the first aperture, the actuator is the first actuator, and the system further comprises a second channel, a second aperture in fluid communication with the second channel, and a second actuator configured to control the flow resistance through the second actuator. The second actuator can be operated independently of the first actuator. The system according to any one of Examples 1 to 16. 18. The system according to any one of Examples 1 to 17, wherein the system is an intraocular shunt system for draining fluid from the anterior chamber of a patient's eye. 19. A system for selectively controlling fluid flow in a patient, the system comprising a drainage element having a channel extending therethrough and an aperture in fluid communication with the channel, an actuator coupled to the drainage element and configured to control the flow of fluid through the aperture, the actuator comprising a control element pivotally movable relative to the drainage element, a first actuating element coupled to the control element, the first actuating element being configured such that when actuated, the control element is pivotally movable in a first direction, a second actuating element coupled to the control element, the second actuating element being configured such that when actuated, the control element is pivotally movable in a second direction different from the first direction. The system comprises 20. The system according to Example 19, wherein the control element is an elongated protrusion. 21. The system according to Example 19 or 20, comprising a blocking mechanism, wherein the control element interfaces with the aperture and is configured to control the flow of fluid therethrough. 22. The system according to Example 21, wherein the blocking mechanism is pivotally movable between a first position that blocks or substantially blocks fluid flow through the aperture and a second position that permits fluid flow to the aperture. 23. The system according to any one of Examples 19 to 22, wherein the shut-off mechanism shows substantially no recoil when moved from the first position to the second position. 24. A first target element configured to receive energy from an external energy source and to disperse heat within a first actuating element, and a second target element configured to receive energy from an external energy source and to disperse heat within a second actuating element, further comprising, The system according to any one of Examples 19 to 23, wherein the first target element and the second target element can be independently energized. 25. The system according to Example 24, wherein the first target element is positioned at a central portion of the first actuating element and the second target element is positioned at a central portion of the second actuating element. 26. The system according to Example 24 or 25, wherein the control element, the first actuating element, the second actuating element, the first target element, and the second target element form an integral structure. 27. The system according to Example 26, wherein the integral structure is composed of a shape memory material. 28. The system according to any one of Examples 19 to 27, wherein the first actuating element and the second actuating element are composed of a shape memory material. 29. The system according to any one of Examples 19 to 28, wherein the drainage element includes a substantially rigid inner structure that houses the actuator and a semi-flexible outer structure that at least partially encloses the substantially rigid inner structure. 30. The system according to Example 29, wherein the substantially rigid inner structure is a plate, the semi-flexible outer structure is a casing, and the plate forms a fluid seal with the casing to prevent fluid leakage between the plate and the casing. 31. The system according to Example 29 or 30, wherein the semi-flexible outer structure includes an opening, the substantially rigid inner structure includes an aperture, and the aperture is aligned with the opening. 32. The channel is the first channel, the aperture is the first aperture, the actuator is the first actuator, and the system further comprises a second channel, a second aperture in fluid communication with the second channel, and a second actuator configured to control the flow resistance through the second actuator, and the second actuator can be operated independently of the first actuator. The system according to any one of Examples 19 to 31. 33. The system according to any one of Examples 19 to 32, wherein the system is an intraocular shunt system for draining fluid from the anterior chamber of a patient's eye. 34. A shunt system for selectively controlling fluid flow from the anterior chamber of a patient's eye, the system comprising: a drainage element having an inflow portion configured to be disposed within the anterior chamber outside the visual field of the patient's vision and an outflow portion configured to be disposed at a different location of the eye; an actuator, a rotary control element operably coupled to the inflow portion and / or the outflow portion of the drainage element; an operating element coupled to the rotary control element and configured to selectively change the orientation of the rotary control element, the actuator comprising the operating element; a shunt system in which the fluid resistance through the inflow portion and / or the outflow portion varies based on the selected orientation of the rotary control element. 35. The system according to Example 34, wherein the inflow portion comprises one or more apertures that allow fluid flow therethrough, and the rotary control element is operably coupled to the inflow portion. 36. The rotary control element is movable between a first orientation and a second orientation, in the first orientation, the rotary control element at least partially interferes with one or more apertures, in the second orientation, one or more apertures are accessible and the rotary control element is at least partially spaced apart from the one or more apertures. The system according to Example 35. 37. The system according to any one of embodiments 34 to 36, wherein the actuating element is configured to change its geometric shape in response to a stimulus, and the change in the geometric shape changes the orientation of the rotary control element. 38. The system according to any one of embodiments 34 to 37, further comprising a second actuating element, wherein the actuating element is a first actuating element, the actuator is coupled to the rotary control element, and is configured to selectively change the orientation of the rotary control element. When the first actuating element is actuated, it is configured to rotatably move the rotary control element in a first direction. When the second actuating element is actuated, it is configured to rotatably move the rotary control element in a second direction, and the second direction is opposite to the first direction. 39. The system according to any one of embodiments 34 to 38, wherein the rotary control element is an elongated protrusion. 40. A method for controlling the flow of fluid through an adjustable shunt system having a drainage element and a control element configured to interface with an aperture in fluid communication with the drainage element, the method comprising: shunting fluid from a first body region of a patient to a second body region of the patient via the drainage element; selectively adjusting the drainage rate of fluid through the drainage element by pivotally moving an elongated control element relative to the drainage element, wherein pivotally moving the elongated control element changes the flow resistance through the aperture. 41. The method according to embodiment 40, wherein selectively adjusting the drainage rate includes decreasing the drainage rate by pivotally moving the elongated control element to increase the flow resistance through the aperture. 42. The method according to embodiment 40, wherein selectively adjusting the drainage rate includes increasing the drainage rate by pivotally moving the elongated control element to decrease the flow resistance through the aperture. 43. The method according to any one of Examples 40 to 42, wherein pivotably moving the elongated control element includes moving the control element towards or away from the aperture. 44. The method according to any one of Examples 40 to 43, wherein pivotably moving the elongated control element includes rotating a first end portion of the elongated control element about a pivotable anchor such that a second end portion of the elongated control element rotates relative to the drainage element. 45. The method according to any one of Examples 40 to 44, wherein pivotably moving the elongated control element includes actuating a shape memory actuating element operably coupled to the elongated control element. 46. The method according to Example 45, wherein actuating the shape memory actuating element includes delivering energy from an energy source positioned outside the patient's body to the shape memory actuator. 47. The method according to Example 45 or 46, wherein actuating the shape memory actuator includes changing the geometric shape of the shape memory actuating element. 48. The method according to any one of Examples 40 to 47, wherein the first body region is the anterior chamber of the patient's eye, the second body region is another part of the patient's eye spaced apart from the anterior chamber, and the fluid is water. 49. A method of manufacturing an adjustable fluid shunt system, the method comprising: fabricating an actuator at least partially composed of a shape memory material, the actuator having one or more actuating elements and a rotary control element; fixing the actuator to the drainage element; deforming the actuator with respect to its fabricated geometric shape; and when the actuator is deformed and fixed to the drainage element, the rotary control element is configured to rotatably interface with one or more apertures in the drainage element to at least partially control the flow of fluid therethrough. 50. The method according to embodiment 49, wherein deforming the actuator with respect to the fabricated geometric shape includes coupling a first portion of the actuator to a second portion of the actuator. 51. The method according to embodiment 49 or 50, wherein deforming the actuator with respect to the fabricated geometric shape includes stretching the actuating element. 52. The method according to embodiment 49 or 50, wherein deforming the actuator with respect to the fabricated geometric shape includes compressing the actuating element. 53. The method according to any one of embodiments 49 to 52, wherein the actuator is deformed with respect to the fabricated geometric shape by fixing the actuator to the drainage element. 54. The method according to any one of embodiments 49 to 52, wherein deforming the actuator with respect to the fabricated geometric shape is performed after fixing the actuator to the drainage element. 55. The method according to any one of embodiments 49 to 54, wherein fixing the actuator to the drainage element includes sealing the shunt system so that flow can pass only through one or more apertures. 56. The method according to any one of embodiments 49 to 55, wherein fixing the deformed actuator to the drainage element includes rotatably coupling a portion of the actuator to the drainage element.
[0134] 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 detailed forms disclosed above. Specific embodiments of the technology and examples of the technology have been described above for illustrative purposes, but as will be recognized by those skilled in the art, various equivalent changes are possible within the scope of the 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 shunts described herein, and vice versa. For example, although steps are presented in a given order, in alternative embodiments the steps can be performed in a different order. The various embodiments described herein can also be combined to provide further embodiments.
[0135] From the foregoing, while specific embodiments of the present technology have been described herein for illustrative purposes, well-known structures and functions associated with intraocular shunts have not been shown or described in detail so as to avoid unnecessarily obscuring the description of the embodiments of the present technology. Where the context permits, the singular or plural terms may also include the plural or singular terms, respectively.
[0136] Unless the context clearly requires otherwise, throughout the description and the examples, words such as "comprise", "comprising", etc. are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is, they are to be interpreted as "including, but not limited to". As used herein, the terms "connected", "coupled", or any variation thereof, mean any direct or indirect connection or coupling between two or more elements, and the connection or coupling between elements can be physical, logical, or a combination thereof. Also, as used herein, the words "herein", "above", "below", and words of similar import refer to the entire present application and not to a particular part of the present application. Wherever possible in the context, the words in the above detailed description using the singular or plural number may also include the plural or singular number respectively. As used herein, a phrase such as "and / or" within "A and / or B" refers to A only, B only, and both A and B. Additionally, the term "comprising" is used throughout to mean including at least the recited features so that any greater number of the same features and / or additional types of other features are not excluded. While specific embodiments have been described herein for purposes of illustration, it will be understood that various modifications can be made without departing from the technology. Further, while the advantages associated with some embodiments of the technology are described in the context of those embodiments, other embodiments can also exhibit such advantages, and not all embodiments necessarily exhibit such advantages in order to fall within the scope of the technology. Accordingly, the present disclosure and related technologies can include other embodiments not expressly illustrated or described herein.
Claims
【Claim 1】 The invention described in this specification.
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