Methods of manufacturing implantable shunt actuators and associated systems and devices

Abstract

The present technology is generally directed to methods of manufacturing actuators of shunting systems, and associated systems and devices. For example, the disclosed method may include forming a film of a target material onto a substrate, extracting a predetermined shape of the film, and applying heat treatment to the extracted predetermined shape of the film. Forming the film can include loading the substrate and the target material in a vacuum chamber such that the substrate is loaded coaxially around the target material with a gap therebetween, and vaporizing the target material such that the target material is deposited onto the substrate as the film. The shape-memory alloy of the film can undergo a transformation from a first material phase to a second material phase during the heat treatment. The film can have a shape-memory alloy purity of at least 70%.

Description

METHODS OF MANUFACTURING IMPLANTABLE SHUNTACTUATORS AND ASSOCIATED SYSTEMS AND DEVICESCROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] The present application claims the benefit of U.S. Provisional Patent Application No. 63 / 609,449, filed Dec. 13, 2023, the disclosure of which is incorporated herein by reference in its entirety.TECHNICAL FIELD

[0002] The present technology generally relates to methods of manufacturing implantable medical devices and, in particular, to methods of manufacturing implantable shunting system actuators using physical vapor deposition processes.BACKGROUND

[0003] Implantable shunts have been used to treat glaucoma by creating an artificial drainage pathway from the anterior chamber to relieve excess pressure in the anterior chamber. As part of the surgical procedure to implant the shunt, a surgeon may create a "‘bleb,” which can be a chamber or other opening in the patient’s eye, such as a small, blister-like elevation that forms on the surface of the eye or at another suitable location. The bleb can serve as a target outflow location for shunting fluid from the anterior chamber via the shunt. It may be advantageous to include one or more actuators in the implantable shunt to selectively shunt fluid at desired time periods. However, given the size and operational constraints of implantable shunts, it can be important to manufacture actuators with specific material properties and operational characteristics. Therefore, there is a need for effective methods for manufacturing such actuators to achieve the necessary material properties.BRIEF DESCRIPTION OF THE DRAWINGS

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

[0005] FIGS. 1A and IB are partially schematic perspective and cross-sectional views, respectively, of a physical vapor deposition system configured in accordance with an embodiment of the present technology.

[0006] FIG. 2 is an exploded perspective view of a shunting system configured in accordance with an embodiment of the present technology.

[0007] FIG. 3 is a top view of a shunting system actuator configured in accordance with an embodiment of the present technology.

[0008] FIG. 4 is a flowchart illustrating a method of manufacturing a shunting system actuator configured in accordance with an embodiment of the present technology7.DETAILED DESCRIPTION

[0009] The present technology is generally directed to methods of manufacturing actuators for use with adjustable implantable shunting systems and associated systems and devices. Shunting systems are commonly used to promote the flow of fluid between a first body region, such as the anterior chamber of an eye, and a second body region, such as a bleb surgically created in / on the eye. As described throughout this Detailed Description, it can be advantageous to include one or more actuators in a shunting system to selectively shunt fluid at desired time periods. However, given the size and operational constraints of shunting systems, such actuators may need to be manufactured with specific material properties and / or operational characteristics.

[0010] The manufacturing methods configured in accordance with the present technology can use a physical vapor deposition (PVD) process to manufacture actuators made of Nitinol or other shape memory alloys. For example, in many embodiments described herein, the methods can include forming a film via a PVD process, extracting a predetermined shape of the film, and applying heat treatment to the extracted predetermined shape of the film to manufacture the actuator. In some embodiments, the process includes loading a substrate and a target material in a vacuum chamber such that the substrate is loaded coaxially around the target material with a gap therebetween. The process can also include vaporizing the target material such that the target material is deposited onto the substrate as the film.

[0011] In some embodiments, the predetermined shape of the film can be obtained by applying a mask with one or more cutouts in the predetermined shape to the substrate prior to vaporizing the target material. When the target material is vaporized, the target material is deposited onto the substrate only within the cutouts of the mask. The mask can then be removedfrom the substrate, leaving the predetermined shape of the film. In some embodiments, the target material is vaporized without a mask, the substrate (with the film deposited thereon) can be removed from the vacuum chamber and flattened, and the film can be cut to the predetermined shape.

[0012] In some embodiments, the target material comprises Nitinol or other shape memory alloy. The shape memory alloy may undergo transformation from a first material phase to a second material phase during the heat treatment such that during use of the shunting system, the shape of the actuator can be manipulated. The PVD process is expected to enable a high Nitinol (or other material) purity in the actuator.

[0013] The terminology used in the description presented below is intended to be interpreted in its broadest reasonable manner, even though it is being used in conjunction with a detailed description of certain specific embodiments of the present technology7. Certain terms may even be emphasized below; however, any terminology intended to be interpreted in any- restricted manner will be overtly and specifically defined as such in this Detailed Description section. Additionally, the present technology can include other embodiments that are within the scope of the claims, but are not described in detail with respect to FIGS. 1 A-4.

[0014] Reference throughout this specification to '‘one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present technology-. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features or characteristics may be combined in any suitable manner in one or more embodiments.

[0015] As used herein, the use of relative terminology7, such as “about,” “approximately,” “substantially” and the like refer to the stated value plus or minus ten percent. For example, the use of the term “about 100” refers to a range of from 90 to 110. inclusive. In instances in which the context requires otherwise and / or relative terminology is used in reference to something that does not include a numerical value, the terms are given their ordinary- meaning to one skilled in the art.

[0016] The headings below are provided by way of convenience only and are not to be used to interpret the scope of the claimed technology.A. Select Embodiment of a Physical Vapor Deposition System

[0017] FIGS. 1A and IB are partially schematic perspective and cross-sectional views, respectively, of a physical vapor deposition (PVD) system 100 configured in accordance with an embodiment of the present technology. As described in further detail below with respect to FIGS. 2-4, the PVD system 100 can be used to manufacture actuators for adjustable shunting systems. Referring to FIGS. 1A and IB together, the PVD system 100 can include a vacuum chamber 110 with a vacuum port 112, a vacuum source 114 operably coupled to the vacuum chamber 110 via the vacuum port 112, a substrate 120 loaded within the vacuum chamber 110, a target material 130 loaded within the vacuum chamber 1 10. For illustrative purposes, the vacuum chamber 110 is made transparent to avoid obscuring the arrangement of the substrate 120 and the target material 130. The PVD system 100 can additionally include a vaporizer 140, a shape extractor, and / or a heat treatment applicator 180. In some embodiments, the shape extractor includes a mask 150 that can serve as a stencil, as described in further detail herein. In some embodiments, the shape extractor includes a flattening device 160 and a cutting device 170.

[0018] In the illustrated embodiment, the substrate 120 is loaded coaxially around the target material 130 with a gap G therebetween. More specifically, as shown in FIG. 1A, the vacuum chamber 110 has a cylindrical form, the substrate 120 has a cylindrical shell form along the walls of the vacuum chamber 110. and the target material 130 has a cylindrical form that is concentric with the vacuum chamber 110 and / or the substrate 120 and is surrounded by the substrate 120. The gap G can be uniform in all radial directions between the substrate 120 and the target material 130. Moreover, as shown in FIG. IB, the substrate 120 and the target material 130 extend coaxially by generally similar or identical lengths within the vacuum chamber 110. In other embodiments, the substrate 120 and / or the target material 130 can be loaded coaxially in different forms (e.g., with a rectangular, triangular, elliptical, or other cross-section). The substrate 120 can be made from glass, metal, polymers (e.g., polyimide or other plastics), ceramics, other suitable materials, or combinations thereof. The target material 130 can be made from a shape memory alloy such as Nitinol, or other suitable materials for the desired application (e.g., shunting system actuator).

[0019] During operation of the PVD system 100, once the substrate 120 and the target material 130 are loaded inside the vacuum chamber 110 as shown, the vacuum chamber 110 can be evacuated by, for example, using the vacuum port 112. The vaporizer 140 can then vaporize(e.g., at least a portion of) the target material 130 such that the target material 130, in vapor form, travels through the gap G towards the substrate 120. as illustrated by arrows in FIG. IB. The vaporizer 140 can vaporize the target material 130 using thermal evaporation, arc vaporization, laser ablation, sputtering, and / or the like. Once the vaporized target material 130 reaches the substrate 120, the target material 130 is deposited as a fdm 132 on the surface of the substrate 120.

[0020] Depending on the desired application, such as manufacturing adjustable shunting system actuators, a predetermined shape of the film 132 can be extracted. One method of extracting the predetermined shape is to use the mask 150. Prior to vaporizing the target material 130, the mask 150 with one or more predetermined shape cutouts can be applied to the substrate 120. The mask 150 can serve as a stencil, allowing the vaporized target material 130 to reach the substrate 120 and form the film 132 only within the one or more predetermined shape cutouts. Once the PVD process is complete, the mask 150 can be removed from the substrate 120, leaving the film 132 with the predetermined shape to be extracted from the substrate 120. Another method of extracting the predetermined shape is to allow the vaporized target material 130 to form the film 132 on the substrate 120 without a mask, remove the substrate 120 with the film 132 from the vacuum chamber 110, unroll and / or flatten the substrate 120 with the film 132 using the flattening device 160 (e.g., heat annealing device), and cut, using the cutting device 170 (e.g., waterjet cutter, laser cutter, CNC router, wire electrical discharge machining (EDM) machine, ultrasonic cutter), the predetermined shape from the film 132 (with or without the substrate 120).

[0021] The PVD system 100 can be advantageous for manufacturing shunting system actuators and other medical device components, as the resulting component can have a high degree of purity of the target material. In some embodiments, for example, the resulting component has a target material (e.g., Nitinol) purity of at least 50%, 60%, 70%, 80%, 90%, 95%, 97%, 99%, 99.9%, or within a range of 70-99.9%, 80-99.9%, or 90-99.9%. The PVD system 100 can also be advantageous in that the coaxial arrangement of the substrate 120 and the target material 130 are expected to enable a high degree of temperature control for the substrate 120 and / or the target material 130 during the PVD process, which enables the manufacturing process to achieve specific microstructures in and mechanical properties of the resulting actuator.B. Select Embodiments of Shunting Systems and Actuators

[0022] FIG. 2 is an exploded perspective view of a shunting system 200 (“the system 200”) configured in accordance with an embodiment of the present technology. The system 200 can be configured to shunt fluid from a first body region to a second body region, such as shunting aqueous from an anterior chamber of a patient’s eye to a target outflow location (e.g., a bleb). As described further herein, the system 200 can include one or more shunting system actuators 224 (shown schematically) that can be manufactured with the PVD system 100 illustrated in and described above with respect to FIGS. 1 A and IB.

[0023] The system 200 includes a shunting element 202 extending between a first end portion 202a and a second end portion 202b. When the system 200 is implanted in a patient, the shunting element 202 can be oriented such that the first end portion 202a is at or proximate to the anterior chamber of an eye and the second end portion 202b is at or proximate to a bleb. The shunting element 202 can include one or more components and / or layers that are stacked and coupled (e.g., sealed) together to collectively form the shunting element 202. For example, the shunting element 202 can include a first (e.g., top) layer 210, a second (e.g., middle) layer 212, and a third (e.g., bottom) layer 214. The shunting element 202 can also include an actuation assembly 220 disposed between the first layer 210 and the second layer 212. Accordingly, in the illustrated embodiment, the shunting element 202 includes three layers, although in other embodiments the shunting element 202 can include more or fewer layers, such as one, two. four, five, six, or more layers. In operation, the first layer 210, the second layer 212, and the third layer 214 are sealed together (e.g., glued, adhered, bonded, etc.) to form the shunting element 202. More specifically, a lower surface of the first layer 210 is sealed to an upper surface of the second layer 212, and a lower surface of the second layer 212 is sealed to an upper surface of the third layer 214. Sealing the layers prevents or at least reduces fluid from leaking through the system 200 between layers. Additional details regarding multi-layered shunting systems are described in International Patent Application No. PCT / US2022 / 037917, the disclosure of which is incorporated by reference herein in its entirety. In other embodiments, the shunting element 202 is formed from a single, contiguous structure, without the need for sealing a plurality of layers together.

[0024] The first layer 210 includes an opening 211 that permits fluid to flow into the shunting element 202 (or, depending on the orientation of, and direction of flow through, the shunting element 202, fluid can flow out of the opening 211). In addition to permitting fluid toflow into the shunting element 202, the opening 211 enables a user to have an unobstructed view of at least a portion of the actuation assembly 220. For example, when the system 200 is assembled, a portion of the actuation assembly 220 can be aligned with the opening 211. Although shown as having a single opening, in some embodiments the first layer 210 may have two more openings.

[0025] The second layer 212 includes a chamber or cavity 216 at the first end portion 202a, with an opening to the chamber 216 facing toward the first layer 210. The chamber 216 provides an empty space or cavity for receiving an actuation assembly 220, described below. The chamber 216 also includes several openings (e.g., ports, apertures, etc.). For example, the chamber 216 includes a first aperture 217a, a second aperture 217b, and a third aperture 217c (collectively referred to as “the apertures 217'’). The apertures 217 extend fully through the second layer 212 such that fluid can flow through the second layer 212 via the apertures 217.

[0026] The third layer 214 defines or at least partially defines plurality of flow channels that extends through the shunting element 202. In the illustrated embodiment, for example, the third layer 214 defines a first channel 204a, a second channel 204b, and a third channel 204c (collectively referred to as “the channels 204”). More specifically, a void space of the channels 204 can be formed within the third layer 214, with the second layer 212 forming a “top” of the channels 204 (e.g.. the channels 204 become closed off once the second layer 212 is sealed to the third layer 214). The third layer 214 also defines a first well 215a fluidly coupled to the first channel 204a at the first end portion 202a, a second well 215b fluidly coupled to the second channel 204b at the first end portion 202a, and a third well 215c fluidly coupled to the third channel 204c at the first end portion 202a. The first well 215a is aligned with, and therefore configured to receive fluid from, the first aperture 217a of the second layer 212. Likewise, the second well 215b is aligned with, and therefore configured to receive fluid from, the second aperture 217b of the second layer 212, and the third well 215c is aligned with, and therefore configured to receive fluid from, the third aperture 217c.

[0027] In the illustrated embodiment, the actuation assembly 220 includes the one or more actuators 224, a first plate 230, and a second plate 240. More specifically, the actuation assembly 220 includes two actuators 224, one positioned to selectively control fluid resistance and / or fluid flow through the first aperture 217a of the second layer 212 (and thus through the first channel 204a) and another positioned to selectively control fluid resistance and / or fluid flow through the second aperture 217b of the second layer 212 (and thus through the second channel 204b). Theactuation assembly 220 may not include an actuator positioned to selectively control fluid resistance and / or fluid flow through the third aperture 217c of the second layer 212 (and thus through the third channel 204c), instead allowing the third channel 204c to be ‘'always open’’ such that it permits at least some degree of fluid flow through the system 200 even when both the first channel 204a and the second channel 204b are blocked or closed. As described in further detail below with respect to FIGS. 3 and 4, the actuators 224 can be manufactured using the PVD system 100 illustrated in and described above with respect to FIGS. 1 A and IB.

[0028] A person skilled in the art will appreciate that the system 200 is just one example of a shunting system that can include actuators manufactured in accordance with embodiments of the present technology. Indeed, actuators manufactured as disclosed herein can be used with other shunting systems, such as those described in U.S. Patent Application Publication Nos. US2020 / 0229982 and US2021 / 0251806, and International Patent Application Nos. PCT / US2021 / 049140, PCT / US2022 / 037747, and PCT / US2022 / 037917, each of which is incorporated by reference herein in its entirety, as well as other shunting systems.

[0029] FIG. 3 is a top view of a shunting system actuator 324 configured in accordance with an embodiment of the present technology. The actuator 324 can be an example of the actuators 224 included in the system 200, and can be manufactured using the PVD system 100. The actuator 324 is generally flat and includes first actuation element 308a, second actuation element 308b (collectively referred to as "the actuation elements 308”). first target 310a, second target 310b (collectively referred to as “the targets 310”), and a projection 302 with a proximal portion 301 and a distal portion 303.

[0030] The proximal end 301 of the projection 302 can be at least partially restrained and rotatably coupled to the rest of a shunting system (e.g., the system 200) by restraint 320. The first target 310a can be at least partially restrained by restraints 324a and 326a, and the second target 310b can similarly be at least partially restrained by restraints 324b and 326b. The restraints 326a and 326b do not necessarily directly couple the actuator 324 to the rest of a shunting system, but rather reduces or prevents the actuation elements 308 and / or the targets 310 from rotating or bending inwardly toward the projection 302. The first actuation element 308a can be at least partially restrained by restraint 328a. and the second actuation element 308b can be at least partially restrained by restraint 328b. Like the restraints 326a, 326b, the restraints 328a, 328b do not necessarily directly couple the actuation elements 308 directly to the rest of a shunting system, but nevertheless can prevent or reduce the actuation elements 308 from bowingor otherwise migrating inwardly toward the projection 302. As a result of the restraints 328a, 328b, each of the actuation elements 308 a first (e.g., generally linear) region 308ai. 308bi extending from the targets 310 and a second (e.g., non-linear or curved region) 308a2, 308b2 extending between the first regions 308ai, 308bi and the projection 302. As mentioned above, the PVD system 100 can be used to manufacture the actuator 324 (excluding the restraints 320, 324a. 324b, 326a, 326b, 328a, 328b).

[0031] In some embodiments, the actuation elements 308, the targets 310, and / or the actuator 324 in its entirety can be made at least partially of a shape memory material or alloy such as Nitinol. Accordingly, each of the actuation elements 308 can be transitionable at least between a first material phase or state (e.g., a martensitic state, a R-phase, a composite state between martensitic and R-phase, etc.) and a second material phase or state (e.g., an austenitic state, an R-phase state, a composite state between austenitic and R-phase, etc.) when heat treatment is applied (e.g., by the heat treatment applicator 180) to, for example, the targets 310. Actuators used in shunting systems may leverage shape memory properties of materials such as Nitinol and require precise movement of the components when transitioning between different material states. Therefore, it is important to be able to manufacture such actuators with high and / or precise Nitinol (or other material) purity. As discussed above, the PVD system 100 is expected to enable the manufacture of actuators with high material purity, resulting in improved functionality of the shunting system in which the actuators are included.

[0032] Additional details regarding, and examples of, bi-directional shape memory actuators that can be manufactured with the present technology7are described in U. S. Patent Nos. 11,166.849 and 11,291,585, U.S. Patent Application Publication Nos. US 2020 / 0229977, US 2020 / 0229982. US 2021 / 0251806, US 2022 / 0142818, and US 2022 / 0202613, International Patent Application Nos. PCT / US20 / 55144 and PCT / US20 / 55141, and U.S. Provisional Patent Application Nos. 63 / 486,436, 63 / 497,127, and 63 / 580,878, the disclosures of which are all incorporated by reference herein in their entireties and for all purposes.C. Methods of Manufacturing Shunting System Actuators

[0033] FIG. 4 is a flowchart illustrating a method 400 of manufacturing a shunting system actuator configured in accordance with an embodiment of the present technology7. Beginning at block 410, the method 400 can include forming a film (e.g., the film 132) via a physical vapor deposition (PVD) process. In some embodiments, the PVD process includes loading a substrate (e.g., the substrate 120) and a target material (e.g.. the target material 130) in a vacuum chamber(e.g., the vacuum chamber 110). The substrate can be loaded coaxially around the target material with a gap therebetween (e.g., as illustrated in FIGS. 1A and IB). The coaxial arrangement can enable a high degree of temperature control of the substrate 120 and / or the target material 130 during the PVD process, which may in turn enable specific microstructures to be formed in the resulting actuator. In some embodiments, the substrate is loaded in a cylindrical shell form and the target material is loaded in a cylindrical form concentric with and surrounded by the substrate. In some embodiments, the PVD process also includes vaporizing (e.g.. via the vaporizer 140) the target material such that the target material is deposited onto the substrate as the film.

[0034] In some embodiments, the PVD process further comprises, prior to vaporizing the target material, applying a mask (e.g., the mask 150) with the predetermined shape onto the substrate, and extracting the predetermined shape of the film comprises removing the mask from the substrate. In some embodiments, extracting the predetermined shape of the film comprises removing the substrate and the film from the vacuum chamber, flattening the substrate and the film (e.g., using the flattening device 160, such as via heat annealing), and cutting the predetermined shape from the flattened film (e.g., using the cutting device 170, such as via waterjet cutting, laser cutting).

[0035] The method 400 can include, at block 420. extracting a predetermined shape of the film. In some embodiments, the predetermined shape is such that the resulting actuator includes a gating element (e.g., the projection 402). In some embodiments, the shape-memory alloy comprises Nitinol, and the actuator has a Nitinol purity of at least 90%.

[0036] The method 400 can include, at block 430, applying heat treatment (e.g., using the heat treatment applicator 180, such as via laser heating) to the extracted predetermined shape of the film to manufacture a shunting system actuator (e.g., the actuator 224). The shape-memory alloy can undergo transformation from a first material phase to a second material phase during the heat treatment. In some embodiments, the gating element is in a first position not obstructing fluid flow through the shunting system when the shape-memory alloy is in the first material phase, and the gating element is in a second position at least partially obstructing fluid flow through the shunting system when the shape-memory alloy is in the second material phase.Examples

[0037] Several aspects of the present technology are set forth in the following examples. The present technology is illustrated, for example, according to various aspects described below as numbered examples (1, 2, 3, etc.) for convenience. These are provided as examples and do not limit the present technology. It is noted that any of the dependent examples may be combined in any combination, and placed into a respective independent example. The other examples can be presented in a similar maimer.1. A method for manufacturing an actuator of an adjustable shunting system, the method comprising: forming a film of a target material onto a substrate, wherein forming the film comprises: loading the substrate and the target material in a vacuum chamber such that the substrate is loaded coaxially around the target material with a gap therebetween, and vaporizing the target material such that the target material is deposited onto the substrate as the film via a physical vapor deposition (PVD) process, wherein the film includes a shape-memory alloy purity of at least 70%; extracting a predetermined shape of the film; and applying a heat treatment to the extracted predetermined shape of the film to form the actuator, wherein the shape-memory alloy of the film undergoes a transformation from a first material phase to a second material phase during the heat treatment.2. The method of example 1 wherein loading the substrate and the target material comprises: loading the substrate in a cylindrical shell form; and loading the target material in a cylindrical form concentric with and surrounded by the cylindrical shell form of the substrate.3. The method of example 1 or example 2 wherein the shape-memory alloy includes Nitinol, and wherein the film includes a Nitinol purity of at least 90%.4. The method of any one of examples 1-3 wherein the shape-memory alloy includes Nitinol, and wherein the film includes a Nitinol purity of at least 99%.5. The method of any one of examples 1-4 wherein forming the film further comprises applying, prior to vaporizing the target material, a mask onto the substrate, wherein the mask includes a cutout having the predetermined shape, and wherein extracting the predetermined shape of the film comprises removing the mask from the substrate.6. The method of any one of examples 1-5 wherein extracting the predetermined shape of the film comprises: removing the substrate and the film thereon from the vacuum chamber; flattening the substrate and the film thereon; and cutting the predetermined shape from the flattened film.7. The method of example 6 wherein flattening the substrate and the film comprises heat annealing the substrate and the film thereon.8. The method of example 6 or example 7 wherein cutting the predetermined shape comprises at least one of waterjet cutting, laser cutting, CNC router cutting, wire electrical discharge machining, or ultrasonic cutting of the flattened film.9. The method of any one of examples 1-8 wherein vaporizing the target material comprises at least one of thermally evaporating the target material or sputtering the target material.10. The method of any one of examples 1-9 wherein applying the heat treatment comprises applying laser heating to the extracted predetermined shape of the film.11. The method of any one of examples 1-10 wherein the actuator includes a bidirectional shape-memory actuator.12. The method of any one of examples 1-11 wherein the actuator includes a gating element configured to be in (i) a first position allowing fluid flow through the adjustable shunting system when the shape-memory alloy of the film is in the first material phase and (ii) a second position at least partially obstructing fluid flow through the adjustable shunting system when the shape-memory alloy of the film is in the second material phase.13. A system for manufacturing an actuator for an adjustable shunt, the system comprising: a vacuum chamber; a vacuum source operably coupled to the vacuum chamber; a target material loaded in the vacuum chamber; a substrate loaded in the vacuum chamber coaxially around the target material with a gap therebetween; a vaporizer configured to vaporize at least a portion of the target material such that the target material is deposited onto the substrate as a film via a physical vapor deposition (PVD) process, wherein the film includes a purity of a shape-memory alloy of at least 70%; and a shape extractor configured to extract a predetermined shape of the film.14. The system of example 13 wherein the substrate is composed of polyimide.15. The system of example 13 or example 14 wherein the film includes a Nitinol purity of at least 90%.16. The system of any one of examples 13-15 wherein the vaporizer is configured to vaporize at least a portion of the target material via at least one of thermal evaporation or sputtering.17. The system of any one of examples 13-16 wherein the shape extractor includes a mask having a cutout in the predetermined shape.18. The system of any one of examples 13-17 wherein the shape extractor includes: a flattening device configured to unroll and / or flatten the substrate and the film thereon; and a cutting device configured to cut the film into the predetermined shape.19. The system of any one of examples 13-18, further comprising a heat treatment applicator configured to apply heat treatment to the extracted predetermined shape of the film tomanufacture the actuator, wherein the shape memory alloy undergoes transformation from a first material phase to a second material phase during the heat treatment.20. The system of any one of examples 13-19 wherein the gap has a constant dimension around the target material.Conclusion

[0038] The above detailed descriptions of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise form disclosed above. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology, as those skilled in the relevant art will recognize. While steps are presented in a given order, alternative embodiments may perform steps in a different order. Moreover, the various embodiments described herein may also be combined to provide further embodiments. Reference herein to "one embodiment," "an embodiment," or similar formulations means that a particular feature, structure, operation, or characteristic described in connection with the embodiment can be included in at least one embodiment of the present technology. Thus, the appearances of such phrases or formulations herein are not necessarily all referring to the same embodiment.

[0039] For ease of reference, identical reference numbers are used to identify similar or analogous components or features throughout this disclosure, but the use of the same reference number does not imply that the features should be construed to be identical. Indeed, in many examples described herein, identically numbered features have a plurality of embodiments that are distinct in structure and / or function from each other. Furthermore, the same shading may be used to indicate materials in cross section that can be compositionally similar, but the use of the same shading does not imply that the materials should be construed to be identical unless specifically noted herein.

[0040] Moreover, unless the word "or" is expressly limited to mean only a single item exclusive from the other items in reference to a list of two or more items, then the use of "or" in such a list is to be interpreted as including (a) any single item in the list, (b) all of the items in the list, or (c) any combination of the items in the list. Where the context permits, singular or plural terms may also include the plural or singular term, respectively. Additionally, the term "comprising" is used throughout to mean including at least the recited feature(s) such that any greater number of the same feature and / or additional types of other features are not precluded.Directional terms, such as "upper," "lower," "front," "back," "vertical," and "horizontal," may be used herein to express and clarify the relationship between various elements. It should be understood that such terms do not denote absolute orientation. Further, while advantages associated with certain embodiments of the technology have been described in the context of those embodiments, other embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.

Claims

CLAIMSI / 'W e claim:

1. A method for manufacturing an actuator of an adjustable shunting system, the method comprising: forming a film of a target material onto a substrate, wherein forming the film comprises: loading the substrate and the target material in a vacuum chamber such that the substrate is loaded coaxially around the target material with a gap therebetween, and vaporizing the target material such that the target material is deposited onto the substrate as the film via a physical vapor deposition (PVD) process, wherein the film includes a shape-memory alloy purity of at least 70%; extracting a predetermined shape of the film; and applying a heat treatment to the extracted predetermined shape of the film to form the actuator, wherein the shape-memory alloy of the film undergoes a transformation from a first material phase to a second material phase during the heat treatment.

2. The method of claim 1 wherein loading the substrate and the target material comprises: loading the substrate in a cylindrical shell form; and loading the target material in a cylindrical form concentric with and surrounded by the cylindrical shell form of the substrate.

3. The method of claim 1 wherein the shape-memory alloy includes Nitinol, and wherein the film includes a Nitinol purity of at least 90%.

4. The method of claim 1 wherein the shape-memory alloy includes Nitinol, and wherein the film includes a Nitinol purity of at least 99%.

5. The method of claim 1 wherein forming the film further comprises applying, prior to vaporizing the target material, a mask onto the substrate, wherein the mask includes a cutouthaving the predetermined shape, and wherein extracting the predetermined shape of the film comprises removing the mask from the substrate.

6. The method of claim 1 wherein extracting the predetermined shape of the film comprises: removing the substrate and the film thereon from the vacuum chamber; flattening the substrate and the film thereon; and cutting the predetermined shape from the flattened film.

7. The method of claim 6 wherein flattening the substrate and the film comprises heat annealing the substrate and the film thereon.

8. The method of claim 6 wherein cutting the predetermined shape comprises at least one of waterjet cutting, laser cutting. CNC router cutting, wire electrical discharge machining, or ultrasonic cutting of the flattened film.

9. The method of claim 1 wherein vaporizing the target material comprises at least one of thermally evaporating the target material or sputtering the target material.

10. The method of claim 1 wherein applying the heat treatment comprises applying laser heating to the extracted predetermined shape of the film.

11. The method of claim 1 wherein the actuator includes a bi-directional shapememory actuator.

12. The method of claim 1 wherein the actuator includes a gating element configured to be in (i) a first position allowing fluid flow through the adjustable shunting system when the shape-memory alloy of the film is in the first material phase and (ii) a second position at least partially obstructing fluid flow through the adjustable shunting system when the shape-memory alloy of the film is in the second material phase.

13. A system for manufacturing an actuator for an adjustable shunt, the system comprising: a vacuum chamber; a vacuum source operably coupled to the vacuum chamber; a target material loaded in the vacuum chamber; a substrate loaded in the vacuum chamber coaxially around the target material with a gap therebetween; a vaporizer configured to vaporize at least a portion of the target material such that the target material is deposited onto the substrate as a film via a physical vapor deposition (PVD) process, wherein the film includes a purity of a shape-memory alloy of at least 70%; and a shape extractor configured to extract a predetermined shape of the film.

14. The system of claim 13 wherein the substrate is composed of polyimide.

15. The system of claim 13 wherein the film includes aNitinol purity of at least 90%.

16. The system of claim 13 wherein the vaporizer is configured to vaporize at least a portion of the target material via at least one of thermal evaporation or sputtering.

17. The system of claim 13 wherein the shape extractor includes a mask having a cutout in the predetermined shape.

18. The system of claim 13 wherein the shape extractor includes: a flattening device configured to unroll and / or flatten the substrate and the film thereon; and a cutting device configured to cut the film into the predetermined shape.

19. The system of claim 13, further comprising aheat treatment applicator configured to apply heat treatment to the extracted predetermined shape of the film to manufacture the actuator, wherein the shape memory alloy undergoes transformation from a first material phase to a second material phase during the heat treatment.

20. The system of claim 13 wherein the gap has a constant dimension around the target material.

Images