Adjustable shunt systems with shape memory actuators and associated systems and methods

Abstract

The present technology provides an adjustable shunt system having an actuation assembly that can be selectively adjusted to vary the level of treatment provided by a shunt. The actuation assembly may include a shape memory actuator having a plurality of leaflets or protrusions forming a conical shape with openings on both ends of a cone. The actuation assembly may also include one or more membranes that individually enclose or cover individual ones of the plurality of protrusions to form a lumen extending through the conical shape.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 477,104, filed Dec. 23, 2022, and U.S. Provisional Patent Application No. 63 / 511,132, filed Jun. 29, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present technology generally relates to implantable medical devices and, more particularly, to an adjustable shunt system for fluidly connecting a first body region and a second body region. Background Art

[0004] Implantable shunt systems are widely used to treat various patient conditions by diverting fluid from a first body region / cavity to a second body region / cavity. Fluid flow through the shunt system is primarily controlled by the pressure gradient across the shunt lumen and the geometry (e.g., size) of the shunt lumen. One challenge with conventional shunt systems is selecting an appropriate shunt lumen geometry for a particular patient. A lumen that is too small may not provide sufficient treatment for the patient, while a lumen that is too large may introduce new problems for the patient. Nevertheless, most conventional shunts cannot be adjusted once implanted. Thus, once the system is implanted, the treatment provided by the shunt system cannot be adjusted or titrated to meet the individual needs of the patient. Brief Description of the Drawings

[0005] Figure 1A and Figure 1B Illustrates an adjustable shunt system in an expanded configuration and constructed in accordance with selected embodiments of the present technology.

[0006] Figure 2 Illustrates another adjustable shunt system in an expanded configuration and constructed in accordance with selected embodiments of the present technology.

[0007] Figure 3 Illustrates yet another adjustable shunt system in an expanded configuration and constructed in accordance with selected embodiments of the present technology.

[0008] Figure 4 Illustrates yet another adjustable shunt system in an expanded configuration and constructed in accordance with selected embodiments of the present technology.

[0009] Figure 5 Illustrates an actuator used with an adjustable shunt system and constructed in accordance with selected embodiments of the present technology.

[0010] Figure 6 Illustrates another actuator used with an adjustable shunt system and constructed in accordance with selected embodiments of the present technology.

[0011] Figure 7A and Figure 7B illustrates aspects of an actuating assembly configured in accordance with alternative embodiments of the present technology for use with an adjustable shunt system.

[0012] Figure 8 illustrates another adjustable shunt system configured in accordance with alternative embodiments of the present technology. DETAILED DESCRIPTION

[0013] The present technology relates to an adjustable shunt system for shunting fluid between a first body region and a second body region. In many of the embodiments described herein, the adjustable shunt system includes an actuating assembly that can be selectively manipulated after the system has been implanted in a patient to vary the level of treatment provided by the system, such as adjusting treatment according to the changing needs of the patient. The actuating assembly can include a shape memory actuator having a plurality of lobes or protrusions arranged relative to one another to form a generally annular structure having, for example, a generally conical, frustoconical, funnel-shaped, and / or hyperbolic shape. The actuating assembly can also include one or more membranes that individually encapsulate or cover individual ones of the plurality of protrusions to define a lumen extending through the shunt. As described throughout the detailed description, individually encapsulating the protrusions is expected to provide several advantages over a shunt having a lumen formed by a single membrane. As those skilled in the art will understand from the following detailed description, other aspects of the present technology can also provide additional advantages.

[0014] The terms used in the description presented below are intended to be interpreted in their broadest reasonable manner, even if it is used in conjunction with a detailed description of certain specific embodiments of the present technology. Certain terms may even be emphasized below; however, any terms intended to be interpreted in any restricted manner will be disclosed and specifically defined in this detailed description section. Additionally, the present technology can include other embodiments that are within the scope of the examples but not described in detail Figures 1A to 8 herein.

[0015] Reference throughout the 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" throughout the specification are not necessarily all referring to the same embodiment. Additionally, the particular features or characteristics may be combined in any suitable manner in one or more embodiments.

[0016] As used herein, the use of relative terms such as "about," "approximately," "substantially," etc., refers to plus or minus ten percent of the stated value. For example, the use of the term "about 100" refers to a range from 90 to 110 (including the end values). When the context so requires and / or when relative terms are used to refer to things other than numerical values, these terms are given their ordinary meaning as understood by one of ordinary skill in the art.

[0017] Figure 1A Illustrated is an adjustable shunt system 100 ("system 100") in an expanded configuration and constructed in accordance with an alternative embodiment of the present technology. As described in detail below, system 100 can be constructed to shunt fluid between a first body region and a second body region when implanted in a patient (not shown). For example, system 100 can be an interatrial shunt system that is constructed to be implanted across a patient's atrial septum to shunt blood from the patient's left atrium to the right atrium.

[0018] System 100 includes an anchoring or stabilizing feature or structure 110 ("anchoring structure 110") that is constructed to secure system 100 to patient tissue and / or to stabilize the position of system 100 in a desired anatomical location. In the illustrated embodiment, anchoring structure 110 is a wire or filament structure having a generally annular geometry (e.g., a braided or woven wire structure). A radially inward portion 111 of anchoring structure 110 defines a central opening or passage 113. As described in detail below, an actuation assembly 120 can be coupled to anchoring structure 110 and at least partially located within opening 113 and / or extend from a perimeter of radially inward portion 111. Actuation assembly 120 can define or at least partially define a lumen 102 that extends through opening 113, as described in more detail below.

[0019] In the illustrated embodiment, anchoring structure 110 includes a first plurality of flaps or appendages 112 and a second plurality of flaps or appendages 114. In some embodiments, the wire forming the pattern of anchoring structure 110 causes adjacent flaps in the first flaps 112 not to be formed by adjacent segments of the wire structure forming anchoring structure 110. Instead, the wire structure can alternate between forming a first flap 112 on a first side of system 100 and a second flap 114 on a second side of system 100 (e.g., a portion of the wire structure that forms a separate first flap 112 at the 12:00 position can pass to the other side of anchoring structure 110 to form a separate second flap at the 3:00 position and then pass back to form another separate first flap 112 at the 5:00 position, and so on). The first plurality of flaps 112 and the second plurality of flaps 114 are separated by gaps (not shown).

[0020] When the system 100 is deployed across an organizational structure (e.g., the atrial septum—not shown), the system 100 is configured to receive patient tissue between the first flap 112 and the second flap 114 (e.g., in the gap). Additionally, the first plurality of flaps 112 and the second plurality of flaps 114 may be at least partially biased towards each other such that the first flap 112 and the second flap 114 at least partially compress the patient tissue received within the gap to secure the system 100 to the patient tissue. For example, when deployed across the atrial septum, the first flap 112 may reside within the left atrium, the second flap 114 may reside within the right atrium, and the gap between the first flap 112 and the second flap 114 may receive a portion of the patient's atrial septum (e.g., at the fossa ovalis). The first flap 112 may be at least slightly biased towards the second flap 114 (and / or the second flap 114 may be at least slightly biased towards the first flap 112) such that the anchoring structure 110 forms a slight clamping force on this portion of the atrial septum within the gap 118. In some embodiments, the first flap 112 and the second flap 114 are at least partially interleaved such that individual first flaps 112 do not fully overlap individual second flaps 114. Without being bound by theory, it is expected that this will distribute the clamping force over a larger area of the atrial septum.

[0021] The anchoring structure 110 can be at least partially composed of a self-expanding material such that, after undergoing the stresses and strains caused by being collapsed into a delivery tool (e.g., a catheter, sheath, etc.) for delivery, it exhibits an elastic response when deployed at body temperature. For example, the anchoring structure 110 can be at least partially composed of nitinol having a martensite finish temperature below body temperature. Thus, when released from the delivery tool, the anchoring structure 110 can automatically deploy (e.g., self-expand without additional input or manipulation by a clinician) from a collapsed delivery configuration (e.g., positioned within a delivery tool such as a catheter or sheath) to an expanded deployed configuration. In some embodiments, the self-expanding or superelastic properties of the anchoring structure 110 can also enable the anchoring structure 110 to resist plastic mechanical deformation once deployed, and thus can provide a generally stable anchoring mechanism for the system 100. In other embodiments, the anchoring structure 110 can be composed of a material that does not self-expand at body temperature. In one example, the anchoring structure 110 can be composed of nitinol having a martensite finish temperature above body temperature. In such an example, the anchoring structure 110 can be initially released from a delivery tool in a preliminary position (e.g., a collapsed delivery configuration, an intermediate configuration, etc.) and then heated to a temperature above the martensite finish temperature to cause a shape transformation of the anchoring structure 110 toward the deployed configuration. In a second example, the anchoring structure 110 can be composed of a material such as stainless steel (e.g., 316L), a titanium alloy (e.g., TiAl6V4), a cobalt-chromium alloy (e.g., L605), or a polymer (e.g., PEEK). Some embodiments of the second example can self-expand based on the geometric configuration of the anchoring structure 110. Other embodiments can be manually expanded by an operator using tools such as a catheter, suture, balloon, etc. after an initial deployment. Regardless of its material composition, in some embodiments, some or all of the anchoring structures in the anchoring structure 110 can include an insulating or coating material. Examples of suitable materials include, but are not limited to, perylene, polyurethane, ePTFE, etc. In some embodiments, the anchoring structure 110 can include multiple insulating / coating layers (e.g., perylene and polyurethane in alternating layers). The coating material can be selected for: (a) improving the biocompatibility of the anchoring structure 110, (b) improving the lubricity of the anchoring structure 110, and / or (c) improving the inductive properties of the anchoring structure 110, as described in more detail below. Additional details regarding the anchoring features suitable for the system 100 are described in International Patent Application No. PCT / US2022 / 046584, the disclosure of which is incorporated herein by reference in its entirety.

[0022] The actuation assembly 120 includes an actuator 121 that is partially or fully covered by a membrane 130 that is fluid impermeable or at least substantially fluid impermeable to blood and / or other body fluids (the portion of the actuator 121 covered by the membrane 130 is in Figure 1A(shown in dashed lines). The actuator 121 and the membrane 130 together form a generally conical, frustoconical, funnel-shaped, cylindrical, or hyperbolic shape, having openings at both ends of the "cone". In this way, the actuation assembly 120 at least partially defines a lumen 102 that extends through the system 100, as described above. Thus, when the system 100 is implanted in a patient (e.g., across the patient's atrial septum), fluid can flow through the system 100 via the lumen 102 that extends through the actuation assembly 120. As described in detail below, the actuation assembly 120 is configured to change one or more treatment parameters associated with the shunt (e.g., fluid resistance, lumen size, orifice size, flow rate, etc.) to control the treatment provided by the system 100. For example, the actuation assembly 120 can transition between multiple unique positions or configurations, where each unique position or configuration provides a different fluid resistance through the lumen 102.

[0023] As Figure 1B best shown in (which shows the system 100 with the membrane 130 omitted to more clearly illustrate aspects of the actuator 121), the actuator 121 can be formed via one or more wires or wire-like structures. As shown, for example, the actuator 121 can include a plurality of protrusions 122 (e.g., lobes, fingers, wings, struts, flaps, corners, etc.) formed via one or more wires or wire-like structures. The protrusions 122 can be formed to define a desired cylindrical, conical, frustoconical, funnel-shaped, and / or hyperbolic shape. In some embodiments, the plurality of protrusions 122 are formed from a single or common wire structure. In other embodiments, individual protrusions (or less than all of the plurality of protrusions) of the plurality of protrusions 122 can be formed from separate wire structures. Each protrusion 122 generally includes two struts 123 connected via a tip 124, thereby forming a generally "U" or "V" shape. Each individual strut 123 is spaced apart from an individual strut 123 of an adjacent protrusion 122 by a gap 126. This at least partially mechanically separates adjacent protrusions 122 and enables the individual protrusions 122 to be individually encapsulated by a discontinuous portion of the membrane 130, as described in detail below. Overall, the tip 124 forms a generally circular central hole or opening 103 into the lumen 102 (the opening 103 is Figure 1B shown approximately in dashed lines). In different embodiments, the tip 124 can form an alternately shaped opening 103, such as a generally square shape, generally pentagonal or hexagonal shape, oval shape, etc. When the system 100 is implanted in a patient, fluid can flow through the opening 103 as it enters or exits the lumen 102. Although the illustrated embodiment shows the actuator 121 as having six protrusions 122, in other embodiments, the actuator 121 can have fewer or more protrusions, such as two, three, four, five, seven, eight, nine, or more.

[0024] In some embodiments, the strut 123 may include a slight curvature or bend region 125. As described in detail below, the protrusion 122 may be configured to articulate or otherwise bend at the bend region 125 when the actuation assembly 120 transitions to a different configuration to change the flow characteristics through the diverter. For example, to increase the size of the lumen 102 and / or the opening 103 and thus reduce the fluid resistance through the system 100, the protrusion may be deflected radially outward by reducing the degree of curvature at the bend region 125. Conversely, to decrease the size of the lumen 102 and / or the opening 103 and thus increase the fluid resistance through the system 100, the protrusion may be deflected radially inward by increasing the degree of curvature at the bend region 125.

[0025] In some embodiments, the actuator 121 further includes a flange or waist region having a plurality of secondary protrusions 127 that may extend around or from the "base" of the protrusion 122 (additional details of actuators having flanges or secondary protrusions are described below with reference to Figure 5 and Figure 6 ). The actuator flange / secondary protrusions 127 may be positioned adjacent to and in a common plane with the first flap 112 and / or the second flap 114 of the anchoring structure 110 and may thus be coupled to the anchoring structure 110 to secure the actuation assembly 120 to the anchoring structure. For example, the actuation assembly 120 may be mechanically coupled to the anchoring structure 110 at a plurality of connection points 128 (e.g., using sutures, crimps, glue, tape, micromolded fasteners, etc.) that are positioned near the tips of the first flap 112 and / or the second flap 114. In other embodiments, the actuation assembly 120 may be coupled to the anchoring structure 110 via other mechanisms and / or at other locations (e.g., near the radially inward portion 111 of the anchoring structure 110, similar to the embodiment described below with reference to Figure 4 ). Mechanically coupling the actuation assembly 120 to the anchoring structure 110 is expected to stabilize the position of the actuation assembly 120 within the opening 113.

[0026] To facilitate adjustment of the actuating assembly 120, the actuator 121 may be at least partially formed of a shape memory material such as nitinol. Accordingly, the actuator 121 may be capable of transitioning at least between a first material phase or state (e.g., a martensitic state, an R-phase, a composite state between martensite and R-phase, etc.) and a second material phase or state (e.g., an austenitic state, an R-phase state, a composite state between austenite and R-phase, etc.). In the first material state, the actuator 121 may have reduced (e.g., relatively low stiffness) mechanical properties, which renders the actuator 121 more deformable (e.g., plastically compressible, expandable, etc.) relative to when the actuator is in the second material state. In the second material state, the actuator 121 may have increased (e.g., relatively high stiffness) mechanical properties relative to the first material state, resulting in an increased preference for a particular preferred geometry (e.g., an original geometry, a fabricated geometry, a machined geometry, a heat-set geometry, etc.). If the actuator 121 is deformed relative to its preferred geometry when in its first material state, heating the actuator 121 above its transition temperature causes the actuator 121 to move to and / or towards its preferred geometry as it transitions to its second material state. In some embodiments, the actuator 121 is fabricated to have a transition temperature above average body temperature such that the actuator 121 remains in the first material state during and after implantation in a patient. For example, the actuator 121 may have a transition temperature of about 38 degrees Celsius to about 80 degrees Celsius, or about 40 degrees Celsius to about 65 degrees Celsius, or about 40 degrees Celsius to about 55 degrees Celsius, or about 45 degrees Celsius to about 50 degrees Celsius.

[0027] Referring again to Figure 1A, in some embodiments, the actuator 121 is configured such that its preferred / shape memory geometry (also referred to herein as the "reset configuration") defines the minimum treatment size of the lumen 102 (as used herein, the term "minimum treatment size" refers to the minimum size of the lumen 102 when the actuator 121 and the lumen 102 are in the configuration intended for treatment—in some embodiments, the minimum treatment size may thus be greater than the size of the lumen 102 when the actuator 121 is collapsed within the catheter, and / or greater than the size of the lumen 102 shortly after the actuator 121 is deployed from the catheter but before it expands / returns to its preferred geometry). Thus, when the actuator 121 is in its preferred geometry, the lumen 102 provides the highest fluid resistance for the treatment purpose, such as by making the opening 103 have the minimum deployed diameter. Since the actuator 121 has a transition temperature above body temperature and thus is typically in a first material state at body temperature, the actuator 121 can be mechanically deformed at body temperature to change the size of the lumen 102 and / or the opening 103. This can be done, for example, by positioning a catheter carrying an expandable element (e.g., a non-compliant balloon) within the lumen 102 and expanding the expandable member until the actuator 121 is deformed (e.g., expanded or inflated) to the desired position. More specifically, expanding the expandable element can cause the protrusion 122 to deflect radially outward mechanically (e.g., by reducing the curvature at the bending region 125) to increase the diameter of the opening 103, thereby reducing the resistance through the lumen 102. Then, the expandable element can be collapsed and retracted, but the actuator 121 can be configured to maintain its deformed (e.g., expanded or inflated) state by virtue of the material properties associated with the first material state.

[0028] To reduce the size of the lumen 102 and / or the opening 103, the actuator 121 can be heated to a temperature above its transition temperature to transition to a second material state. Transitioning to the second material state causes the actuator 121 to "reset" to its preferred geometry (e.g., the "reset configuration"), which, as described above, can be associated with the minimum deployed size of the lumen 102. For example, thermally resetting the actuator 121 can cause the protrusion 122 to move radially inward (e.g., by bending or increasing the curvature at the bending region 125) to reduce the diameter of the opening 103. In some embodiments, the actuator 121 can be thermally reset via resistive heating. For example, some or all of the anchoring structures 110 can form inductors for generating electrical energy in response to exposure to an electromagnetic field. The anchoring structures 110 can be electrically coupled to the actuator 121 such that the electrical energy generated in the anchoring structures 110 flows into the actuator 121 and resistively heats the actuator 121, e.g., to a temperature above its transition temperature. Referring below to Figure 3 A and Figure 3Additional details regarding incorporating shape memory actuators into RLC circuits and using anchoring structures as inductors are described in B and in International Patent Application Publications WO 2022 / 076601 and WO 2022 / 081980, the disclosures of which are incorporated herein by reference in their entirety.

[0029] Once reset to its preferred geometry and cooled below the transition temperature (e.g., by returning to body temperature), the user can optionally mechanically expand the actuator 121 again to a desired size. Thus, the actuation assembly 120 can be repeatedly and selectively manipulated by the user to adjust the treatment level provided by the system 100. Additional examples and details for operating shape memory actuators of adjustable shunts are described in U.S. Patent Application Publications 2021 / 0085935 and 2022 / 0142652, the disclosures of which are incorporated herein by reference in their entirety.

[0030] Referring again to Figure 1A And as described above, the actuation assembly 120 includes a membrane 130 that covers (e.g., encapsulates) the protrusion 122. The membrane 130 creates / defines the wall of the lumen 102 and thus defines the flow path through which fluid can travel through the system 100. In the absence of such a membrane that defines or at least partially defines the flow channel through the shunt device, the dimensional changes of the above-described lumen 102 and / or opening 103 would have a limited impact on the flow characteristics through the system 100. Notably, the individual protrusions 122 are covered by individual membranes 130 or individual membrane portions such that there is a mechanical separation 132 between adjacent protrusions 122. In embodiments where the individual protrusions 122 are covered by individual membrane portions rather than individual membranes, the membrane 130 can be composed of a single piece of material but can have incisions or slits corresponding to the separations 132 between the individual protrusions 122. As used herein, the term "individually encapsulated" thus includes both covering the individual protrusions 122 with separate individual membranes 130 and covering the individual protrusions 122 with separate portions of a common membrane.

[0031] Compared to the situation where the protrusions 122 are covered by a single continuous membrane (e.g., if there is no mechanical separation or discontinuity between the membrane portions covering adjacent protrusions 122), individually wrapping the individual protrusions 122 is expected to be advantageous because it limits the movement of the protrusions 122 to a lesser extent. This is because when the actuation assembly 120 transitions between various configurations, the membrane 130 and the protrusions 122 do not need to move relative to each other. Thus, the membrane 130 does not need to be made of a flexible or "stretchable" material and / or made of an overly large material (relative to the actuation assembly 120) to accommodate the movement of the protrusions 122 during actuation of the actuation assembly 120, as described above. Instead, when the individual protrusions 122 deflect radially outward or reset radially inward, the membrane 130 can move with these protrusions. Individually wrapping the protrusions 122 also enables the individual protrusions 122 to slide / move relative to each other without substantially stretching the membrane 130. Additionally, in many embodiments, individually wrapping the protrusions 122 eliminates or minimizes the constant radially inward force and / or hoop stress that would be applied to the protrusions 122 by a single continuous membrane when the geometry of the lumen 102 and / or the opening 103 has expanded beyond the reset configuration. Further still, in many embodiments, individually wrapping the protrusions 122 eliminates or minimizes the folded or buckled regions that would be present in a single continuous membrane covering the protrusions 122 when the geometry of the lumen 102 and / or the opening 103 is in a relatively smaller or narrower configuration compared to the maximum or widest configuration that can be achieved.

[0032] At least for the foregoing reasons, individually wrapping the protrusions 122 is expected to increase the types of materials available for the membrane 130. For example, the membrane 130 can be made of a material that is generally more rigid but has favorable biocompatible properties, such as ePTFE. In other embodiments, the membrane 130 can be at least partially made of other suitable materials, such as PTFE, PET, silicone, polyurethane, nylon, etc., or a combination of suitable materials. In some embodiments, the membrane 130 is made of ePTFE with a polyurethane coating. Because individually wrapping the protrusions 122 also reduces the amount by which the membrane 130 is stretched, even if a generally stretchable or elastic material is used for the membrane 130, individually wrapping the protrusions 122 is expected to provide advantages. For example, individually wrapping the protrusions 122 is expected to reduce unwanted wrinkling, bulging, tearing, and / or other deformations that might occur by repeatedly stretching the membrane 130.

[0033] Figure 2 Illustrated is another adjustable shunt system 200 ("system 200") in a deployed configuration and constructed according to an alternative embodiment of the present technology. System 200 can include Figure 1A and Figure 1BCertain features of the system 100 are generally similar. For example, the system 200 may include an anchoring structure 210 that may be generally similar or identical to the anchoring structure 110 of the system 100. The system 200 may also include an actuation assembly 220 having an actuator 221 and a membrane 230 and defining an internal cavity 202 having an opening 203. Similar to the system 100 described with reference Figure 1A and Figure 1B the actuator 221 may include a plurality of protrusions 222 made of a shape memory material for facilitating adjustment of the actuation assembly 220. The protrusions 222 are individually encapsulated by the membrane 230 or a portion of the membrane 230 to reduce the resistance provided by the membrane 230 when adjusting the actuator 121.

[0034] Relative to Figure 1A and Figure 1BSystem 100, when the actuator 121 is in its preferred geometry / reset configuration (e.g., after resetting the actuator 121 to its basic configuration by heating the actuator 121 above its transition temperature), the protrusions 222 of the actuator assembly 120 at least partially overlap. That is, the individual protrusions 222 at least partially overlap with adjacent protrusions 222. In some embodiments, when the actuator 221 is in its preferred geometry / reset configuration, adjacent protrusions 222 may overlap by about 0.1 mm to 2.5 mm, or about 0.1 mm to about 2 mm, or about 0.1 mm to about 1.5 mm, or about 0.5 mm to about 1.5 mm, or about 0.5 mm to about 1.0 mm, or about 0.1 mm to about 1.0 mm, or about 0.1 mm to about 0.5 mm. For example, in some embodiments, adjacent protrusions 222 overlap by about 0.1 mm, about 0.2 mm, about 0.3 mm, about 0.4 mm, about 0.5 mm, about 0.6 mm, about 0.7 mm, about 0.8 mm, about 0.9 mm, about 1.0 mm, about 1.1 mm, about 1.2 mm, about 1.3 mm, about 1.4 mm, about 1.5 mm, about 1.6 mm, about 1.7 mm, about 1.8 mm, about 1.9 mm, about 2.0 mm, about 2.1 mm, about 2.2 mm, about 2.3 mm, about 2.4 mm, or about 2.5 mm. The foregoing ranges and values are provided only as examples - in other embodiments, the protrusions 222 may overlap more or less. Additionally, it is expected that the amount of overlap will vary along the length of the protrusions 222. For example, in the illustrated embodiment, there is more overlap near the base of the protrusion 222 compared to near the tip of the protrusion 222. In some embodiments, this may be reversed such that there is more overlap near the tip of the protrusion 222 compared to near the base of the protrusion 222. In any event, unless the context otherwise clearly indicates, the use of a specific dimension in the context of overlapping flaps refers to the maximum amount of overlap between two adjacent protrusions 222 at any point along their length.

[0035] In some embodiments, the protrusions 222 are configured to overlap when the actuator 212 is in the reset (e.g., narrowest) configuration, but not to overlap when the actuator 221 is in the expanded / inflated (e.g., wider) configuration. In other embodiments, the protrusions 222 may be configured to overlap when the actuator is in the reset configuration and in some but not all of the potential expanded configurations. In other embodiments, the protrusions 222 may be configured to overlap when the actuator is in the reset configuration and in all of the potential expanded configurations. In any event, those skilled in the art will understand that the amount of overlap between adjacent protrusions 222 will vary based on the configuration of the actuator 221.

[0036] Without being bound by theory, the overlapping protrusions 222 can provide at least four advantages relative to non-overlapping protrusions. First, the overlapping protrusions 222 can reduce the amount of fluid that can flow (e.g., leak) between adjacent protrusions 222. Instead, the fluid is more likely to flow through the openings 203 and the inner lumen 202. Second, the overlapping protrusions 222 can at least partially mechanically couple the plurality of protrusions 222, thereby providing stability to the overall shape of the openings 203 during movement of the actuator 221, particularly during mechanical expansion of the actuator 221. For example, during balloon inflation of the actuator assembly 220, to reduce the fluid resistance through the inner lumen 202, the individual protrusions 222 that are radially outwardly pushed by the balloon will apply a mechanical, radially outward force to at least one adjacent protrusion 222 that overlaps therewith. Thus, even if the balloon does not directly contact each protrusion 222, all protrusions 222 are expected to expand radially outwardly uniformly. Third, the overlapping protrusions 222 can more easily collapse into a delivery configuration that can be assembled within a catheter. In other words, the overlapping protrusions 222 can simplify the process of folding or otherwise collapsing the system 200 such that it can be assembled within a catheter that can be percutaneously advanced to a target location within a patient's body for deployment. Fourth, the overlapping protrusions 222 can make it easier to advance a percutaneous tool (e.g., a balloon, catheter, guidewire, etc.) through the corresponding openings 203 and inner lumen 202, as this will reduce the likelihood of the tool getting stuck between adjacent protrusions. Of course, there may be other advantages of the overlapping protrusions in addition to those specifically identified herein, and the present technology is not limited to the foregoing advantages.

[0037] Figure 3 Another adjustable shunt system 300 (“system 300”) is illustrated in the deployed configuration and constructed in accordance with an alternative embodiment of the present technology. System 300 can include certain features that are generally similar to those of Figure 1A and Figure 1B system 100 and Figure 2 system 200. For example, system 300 can include an anchoring structure 310 that is configured to stabilize system 300 across a target anatomical structure (e.g., the atrial septum between the left atrium and the right atrium). However, relative to Figures 1A to 2Systems 100 and 200, the anchoring structure 310 includes a first wire portion 310a and a second wire portion 310b. The first wire portion 310a and the second wire portion 310b may be at least partially composed of a common material, such as nitinol configured to have superelastic properties at body temperature. However, the first wire portion 310a may also include a conductive cladding / coating (e.g., silver or copper cladding) around a nitinol core, while the second wire portion 310b does not include a conductive cladding. In an alternative embodiment, the conductive portion of the material may be inside the nitinol shell. In a further variation, the conductive material may be combined or joined with a material other than nitinol to form a hybrid material structure. In such embodiments, the first wire portion 310a may thus have more favorable electrical properties to be used as an inductor or antenna to wirelessly receive energy transfer (e.g., resistively heat the actuator 321 and / or charge one or more active components of the system 300 such as sensors, other electronics, etc.), while the second wire portion 310b may function with more favorable mechanical properties (e.g., stronger superelasticity) to mechanically stabilize the system 300. In some embodiments, the first wire portion 310a and / or the second wire portion 310b may be joined with other components (e.g., capacitors, inductors, resistors, microcontrollers, etc.) to assist in acting as an inductor or antenna. In some embodiments, the first wire portion 310a and the second wire portion 310b are part of the same wire. In other embodiments, the first wire portion 310a and the second wire portion 310b are part of different wires (e.g., the first wire portion 310a and the second wire portion 310b are discrete wires, e.g., the first wire 310a and the second wire 310b). In some embodiments, the first wire portion 310a and the second wire portion 310b are not electrically connected (e.g., not electrically in series) such that the current generated in the first wire portion 310a does not pass through the second wire portion 310b. In fact, in some embodiments, the first wire portion 310a may form part of a circuit with one or more system components (e.g., the actuator 321), and the second wire portion 310b may form an open circuit that terminates at an electrically insulated end of the second wire portion 310b (e.g., in an epoxy-filled potting cap structure, not shown). Additional details regarding the use of stabilization / anchoring features as inductors are described in International Patent Application Publication No. WO 2022 / 081980, which is hereby incorporated by reference.

[0038] The actuation assembly 320 may also include reference Figures 1A to 2Certain features that are generally similar to those described for the described actuating assemblies 120, 220. For example, the actuating assembly 320 may include an actuator 321 and a membrane 330 that together define a lumen 302 having an opening 303. The actuator 321 may include a plurality of flaps or protrusions 322 made of a shape memory material for facilitating adjustment of the actuating assembly 320. Similar to the reference Figure 2 described system 200, adjacent protrusions 322 at least partially overlap. Also similar to the reference Figures 1A to 2 described systems 100 and 200, the protrusions 322 are individually encapsulated by the membrane 330. As shown, the membrane 330 includes a plurality of first membrane portions 332 (e.g., sleeve segments) that encapsulate the corresponding individual protrusions 322. The membrane 330 also includes a "skirt segment" that includes one or more second membrane portions 334 that encapsulate or otherwise at least partially cover a portion of the adjacent anchoring structure 310 of the actuator 321 (see, for example Figure 5 and Figure 6 ). Additionally, different from systems 100 and 200, the actuating assembly 320 is coupled to a radially inward portion or "waist" 311 of the anchoring structure 310. For example, the actuating assembly 320 is coupled to the radially inward portion 311 via a plurality of connection elements 328 (e.g., sutures, laces, tapes, glues, crimps, molded fasteners, etc.).

[0039] The actuator 321 may be electrically coupled to a first wire portion 310a of the anchoring structure 310. For example, the system 300 may include an electrical connector subassembly 340 where an end portion of the first wire portion 310a is electrically coupled to an end portion of the actuator 321. In some embodiments, the electrical connector subassembly 340 includes a capacitor (not shown) electrically coupled between the first wire portion 310a and the actuator 321. For example, the end portion of the first wire portion 310a may be crimped, welded, or otherwise coupled to a first terminal of the capacitor, and the end portion of the actuator 321 may be crimped, welded, or otherwise coupled to a second terminal of the capacitor. The capacitor and the corresponding connections between the capacitor and the first wire portion 310a and the actuator 321 may be embedded in an epoxy or other suitable material and positioned within a cover (e.g., a titanium cover) to form a potted connection between the first wire portion 310a and the actuator 321. In some embodiments, the entire electrical connector subassembly 340 may be hermetically sealed, for example, in addition to or instead of embedding the capacitor in the epoxy.

[0040] In some embodiments, the actuator 321 and the first wire portion 310a are electrically disconnected from the second wire portion 310b of the anchoring structure 310. That is, the circuit formed by the first wire portion 310a and the actuator 321 does not include the first wire portion 310b. Instead, as described above, the second wire portion 310b may form an "open" circuit that terminates at the insulated end of the second wire portion 310b, such as in a second epoxy-filled potting cap structure (not shown) that is different from the electrical connector subassembly 340. Excluding the second wire portion 310b from the circuit that includes the actuator 321 may be advantageous because it may reduce the total resistance of the circuit in the anchoring structure 310 and provide more efficient energy transfer to the actuator 321.

[0041] To actuate the actuator 321, a user may generate an electromagnetic field around and / or directed at the first wire portion 310a (e.g., via a transmit coil positioned at the distal end portion of a catheter extending proximate the first wire portion 310a). The first wire portion 310a generates electrical energy in response to exposure to the electromagnetic field due to its inductive properties. The generated electrical energy may flow through the first wire portion 310a, through a capacitor (not shown) at the electrical connector subassembly 340, and into the actuator 321. The electrical energy flowing through the actuator 321 may resistively heat the actuator 321. Thus, the first wire portion 310a, the capacitor of the electrical connector subassembly 340, and the actuator 321 form an RLC circuit, where the first wire portion 310a acts as an inductor and the actuator 321 acts as a resistor. In some embodiments, the RLC circuit is configured to ensure that the electrical energy flows in the same direction (e.g., clockwise through the anchoring structure 310 and the actuator 321). Additional details regarding incorporating a shape memory actuator into an RLC circuit are described in International Patent Application Publication No. WO 2022 / 076601, which is hereby incorporated by reference in its entirety.

[0042] Similar to the process for actuating the actuator 121 described above for adjusting Figure 1A and Figure 1B heating the actuator 321 above its transition temperature can "reset" the actuator 321 to its preferred geometry, which may be associated with the minimum deployed size of the inner lumen 302. Once reset to its preferred geometry and cooled below the transition temperature, the user may optionally mechanically expand the actuator 321 to a desired size, e.g., to achieve a desired fluid resistance and / or flow rate through the inner lumen 302.

[0043] Figure 4 Illustrates another adjustable shunt system 400 ("System 400") in a deployed configuration and constructed in accordance with selected embodiments of the present technology. System 400 may include Figures 1A to 3Certain features of the systems 100 - 300 are generally similar. For example, system 400 may include an anchoring structure 410, which may be generally similar or identical to the anchoring structure 110 of system 100. System 400 may also include an actuation assembly 420 having an actuator 421 defining a lumen 402 with an opening 403 and a membrane 430. Similar to the systems 100 - 300 described in reference Figures 1A to 3 The actuator 421 may include a plurality of protrusions 422 made of a shape - memory material to facilitate adjustment of the actuation assembly 420.

[0044] However, relative to Figure 2 system 200 and Figure 3 A and Figure 3 B of system 300, adjacent protrusions 422 are spaced apart by a gap 432. And compared to the system 100 of Figure 1A and Figure 1B the gap 432 between adjacent protrusions 422 is substantially larger. For example, the widest part of the gap 432 can be at least 0.5 mm, at least 1 mm, at least 1.5 mm, or at least 2 mm. Additionally, relative to the system 100 of Figure 1A and Figure 1B the protrusions 422 of system 400 may be formed by substantially parallel struts 423. Thus, the width of the gap 432 decreases towards the tip 424 of the protrusion 422 compared to the width of the gap at the base 425 of the protrusion 422, while the width of the protrusion 422 remains generally constant along its length. One possible advantage of the actuator 421 is that it may allow relatively more flow through system 400 compared to the actuators 321, 221, 121 described in reference Figures 1A to 3 when the struts are in comparable angular configurations. A second possible advantage of the actuator 421 is that the ability to deform the geometry of the struts 423 may be less affected by tissue overgrowth compared to other previously discussed configurations (e.g., any tissue overgrowth is more likely to be confined to individual protrusions 422 rather than growing between / across adjacent protrusions 422, which could inhibit the movement of the protrusions 422).

[0045] Although each of the actuators 121-421 is shown as having generally symmetric protrusions / vanes, in different embodiments, the actuator struts forming the protrusions / vanes and / or the protrusions / vanes themselves may be asymmetrically configured. For example, some embodiments may utilize one or more relatively large struts or protrusions and one or more relatively small struts or protrusions (e.g., at least a pair of asymmetric struts). Some embodiments may utilize struts or protrusions of alternating sizes and / or may utilize struts having different mechanical properties (e.g., resulting from different wire thicknesses) in different sections of the lumen opening. Such embodiments may make the actuator more resistant to unintentional deformation, such as deformation caused by accidental contact via an adjustment tool (e.g., a balloon catheter) during removal of the tool from the body. In other variations, other aspects of the actuator may vary and / or be asymmetric—such as the spacing between struts, the strut coating material and / or thickness or density, the strut height, etc.

[0046] In addition, although Figures 1A to 4 each of the actuators 121-421 is shown as a component separate from the corresponding anchoring structure 110-410, in some embodiments, the actuators 121-141 may be part of the same component as the anchoring structure, such that no specific coupling mechanism (e.g., Figure 1A and Figure 1B the connection point 128 in

[0047] The systems described herein may have actuators other than those shown in Figures 1A to 4 such that the vanes / protrusions on the actuator can be individually coated by a corresponding membrane or membrane portion. For example, Figure 5 illustrates an actuator 521 constructed in accordance with an alternative embodiment of the present technology. Actuator 521 may be referenced Figures 1A to 4The described actuators 121, 221, 321, and 421 function in a substantially similar manner and can thus be used in place of the foregoing actuators with any of the systems 100 - 400. For example, similar to the actuators described above, actuator 521 is formed from one or more wires or wire-like structures and includes a plurality of protrusions 522 that define an internal cavity when actuator 521 is coupled to an anchoring structure (e.g., anchoring structure 110 of system 100). Actuator 521 also includes a plurality of secondary protrusions 528. The secondary protrusions 528 occupy a different plane than the protrusions 522, and if actuator 521 is used with Figure 1A and Figure 1B system 100, the secondary protrusions can be used to couple actuator 521 to the corresponding anchoring structure ( Figure 5 not shown), such as at connection point 128 ( Figure 1A ). Thus, the secondary protrusions 528 can be designed to abut a portion of the anchoring structure (e.g., Figure 1A and Figure 1B tips of the first flap 112 and / or second flap 114 of anchoring structure 110) and be mechanically coupled to that anchoring portion (e.g., via sutures, glue, crimps, molded fasteners, etc.) to stabilize actuator 521 to the anchoring structure. In some embodiments, when actuator 521 is implanted in a patient as part of an adjustable shunt system, the secondary protrusions 528 are configured to reside on a side of the anatomical structure opposite the tips of the protrusions 522. For example, in an embodiment where actuator 521 is used with an adjustable atrial septal shunt system configured to be implanted across a patient's atrial septum, the secondary protrusions 528 can be positioned in the left atrium, and the tips of the protrusions 522 can be positioned in the right atrium, and vice versa. In some embodiments, the secondary protrusions 528 can be at least partially covered by a portion of a membrane that covers the corresponding protrusions 522, such as the skirt segment 334 of membrane 330 described with reference to Figure 3 and / or as described in more detail below with reference to Figure 7A and Figure 7B .

[0048] Figure 6 Illustrates another actuator 621 constructed in accordance with an alternative embodiment of the present technology. Actuator 621 can be used with reference Figures 1A to 4The described actuators 121, 221, 321, and 421 function in a substantially similar manner and can thus be used in place of the foregoing actuators with any of the systems 100 - 400. Similar to the actuators described above, actuator 621 is formed from one or more wires or wire-like structures and includes a plurality of flaps or protrusions 622 that define an inner lumen when the actuator 621 is coupled to an anchoring structure (e.g., anchoring structure 110 of system 100). Actuator 621 also includes a plurality of rings 628. The rings 628 can be used to couple the actuator 621 to a corresponding anchoring structure ( Figure 6 not shown), such as at connection element 328 ( Figure 3 A and Figure 3 B) if the actuator 621 is used with system 300 of Figure 3 . Thus, the rings 628 can abut a portion of the anchoring structure (e.g., Figure 1A and Figure 1B the radially inward portion 111 of anchoring structure 110) and be mechanically coupled to the anchoring structure (e.g., via sutures, glue, crimps, molded fasteners, etc.) to stabilize the actuator 621 to the anchoring structure. When the actuator 621 is deformed relative to its preferred / shape memory geometry (e.g., during balloon inflation to increase the size of the actuator 121 beyond its reset configuration), strain accumulates in the rings 628 (e.g., as opposed to strain accumulating in the designed bending regions of the actuator, such as Figure 1A and Figure 1B actuator 121). In some embodiments, the rings 628 can be covered or overwrapped by a portion of a membrane that covers the respective protrusions 622, such as with the skirt segment 334 of membrane 330 described with reference to Figure 3 and / or as described in more detail below with reference to Figure 7A and Figure 7B .

[0049] The systems described herein can have membranes other than the Figures 1A to 4 membrane shown. For example, Figure 7A illustrates an actuator assembly 720 that can be used with any of the systems described herein. Similar to the actuator assemblies described herein, actuator assembly 720 includes an actuator 721 having a plurality of protrusions 722 and a membrane 730 that individually overwraps the plurality of protrusions 722. Figure 7A illustrates after the protrusions 722 have been formed and covered by the membrane 730 during the manufacturing stage, but before the remaining portion of the wire structure of the actuator 721 has been set to the desired shape for coupling to a corresponding anchoring structure (e.g., secondary protrusions such as the secondary protrusions 528 described with reference to Figure 5 actuator 521 or as described with reference to Figure 6The actuator assembly 720 before the ring 628 (described for the actuator 621) has been formed in the actuator 721. As shown, the membrane 730 includes a plurality of individual membranes 730a - 730e. Each individual membrane 730 includes a first membrane portion 732 (e.g., a sleeve segment) and a second membrane portion 734 (e.g., a skirt segment). Figure 7B An example of a flat pattern of a single membrane 730a is illustrated, and the first membrane portion 732 and the second membrane portion 734 separated at the waist W are illustrated.

[0050] Common reference Figure 7A and Figure 7B and, the first membrane portion 732 of each membrane 730 envelopes a corresponding individual protrusion 722. Thus, the first membrane portion 732 may be composed of two layers forming a pocket for receiving the protrusion 722. The second membrane portion 734 is configured to at least partially cover a portion of the actuator 721 that is configured to abut a corresponding anchoring structure (e.g., a secondary protrusion for coupling to the anchoring structure, such as the secondary protrusion 528 described for the actuator 521 with reference to Figure 5 or the ring 628 described for the actuator 621 with reference to Figure 6 . Notably, in the illustrated embodiment, the second membrane portion 734 is composed of a single layer and thus does not completely envelope the portion of the actuator 721 that is configured to abut the corresponding anchoring structure. Without wishing to be bound by theory, a membrane having a double - layer first portion (e.g., the first membrane portion 732) and a single - layer second portion (e.g., the second membrane portion 734) may be more easily mounted on the protrusion 722 because they define a pocket having a slot or opening through which the protrusion 722 can be inserted. However, as described above, in some embodiments, the membranes described herein may completely envelope the protrusion and the portion of the actuator that is configured to abut the anchoring structure.

[0051] Figure 8 Another embodiment of an adjustable shunt system 800 (“system 800”) constructed in accordance with an alternative embodiment of the present technology is illustrated. System 800 may include certain features that are generally similar to the features of the systems 100 - 400 described in detail above. Figures 1A to 4 For example, system 800 may include an anchoring assembly 808 for anchoring system 800 in a desired anatomical location (e.g., across a patient's atrial septum). System 800 may also include an actuator assembly 820 having a plurality of protrusions or flaps 822 covered by one or more discontinuous membranes 830, as described in detail above with reference to Figure 1A through FIG. 7. The actuator assembly 820 may form a lumen 802 extending through the actuator assembly, e.g., to shunt fluid between a first body region and a second body region when the system 100 is implanted in a patient.

[0052] Relative to the reference Figures 1A to 4 For the described system, the anchoring assembly 808 includes an anchoring structure 810 covered (e.g., disposed within) by an anchoring membrane 809 ("membrane 809"). In some embodiments, the membrane 809 completely encapsulates the anchoring structure 810 such that, for example, when the system 800 is implanted, the anchoring structure 810 is not directly exposed to body fluids. For example, the membrane 809 can be a laminated structure including two sheets of material adhered to the anchoring structure 810 positioned therebetween, a single sheet of material folded to encapsulate the anchoring structure 810, or have other suitable configurations. The membrane 809 can be composed of biocompatible and / or antithrombogenic materials. Example materials include but are not limited to ePTFE, PTFE, PET, silicone, polyurethane, nylon, and the like.

[0053] In some embodiments, the membrane 809 covering the anchoring structure 810 is different from (e.g., not integral with) one or more membranes 830 covering the protrusion 822 of the actuation assembly 820. Thus, the membrane 809 can optionally be composed of a different material than the membrane 830. In other embodiments, the membrane 809 can be integral with one or more membranes 830 covering the protrusion 822.

[0054] The system 800 can also optionally include a canister 840 coupled to the anchoring structure 810 or another part of the system 800. The canister 840 can be a sealed (e.g., airtight) container that houses various electronics and other components of the system 800. For example, the canister 840 can house one or more energy storage components (e.g., primary batteries, rechargeable batteries, capacitors, supercapacitors, etc.), one or more sensors or associated electronic circuits (e.g., pressure sensors, flow sensors, etc.), one or more data storage elements (e.g., memory), one or more processors, one or more telemetry components, one or more microcontrollers, etc. The canister 840 can be composed of a substantially rigid material such as titanium, steel, plastic, etc. The canister 840 can also be covered by a biocompatible membrane composed of, for example, ePTFE or another suitable material. Although shown as having a single canister 840, in other embodiments, the system 800 can have additional canisters, such as two, three, four, or more.

[0055] Those skilled in the art will understand from the disclosure herein that various components of the system described above may be omitted without departing from the scope of the present technology. Similarly, additional components not explicitly described above may be added to the system without departing from the scope of the present technology. In addition, the features described herein may be incorporated into other types of implantable medical devices other than the shunt system. Representative other implantable medical devices include, but are not limited to, occlusion devices (e.g., atrial septal occluders), atrial septal sensor devices having transseptal access ports, stents (e.g., perfusion stents), valves, and the like. Accordingly, the present technology is not limited to the configurations explicitly set forth herein, but encompasses variations and modifications of the described system.

[0056] Embodiments

[0057] Certain aspects of the technology of the present invention are set forth in the following embodiments:

[0058] 1. A shunt system for fluidly connecting a first body region and a second body region of a patient, the system comprising:

[0059] An anchoring structure configured to stabilize the shunt system across a target anatomical structure; and

[0060] An actuation assembly coupled to the anchoring structure, wherein the actuation assembly includes—

[0061] An actuator formed of one or more shape memory wires, the actuator including a plurality of protrusions that together define a cylindrical or conical shape having an inner lumen that extends through the actuator, wherein the tips of the protrusions define openings leading to the inner lumen; and

[0062] A membrane covering the plurality of protrusions, wherein the membrane individually covers each of the plurality of protrusions,

[0063] wherein the actuation assembly is capable of selectively transitioning between at least two or more configurations, and wherein the at least two or more configurations are associated with different fluid resistances through the inner lumen.

[0064] 2. The system according to embodiment 1, wherein the at least two or more configurations include a reset position and one or more expanded configurations.

[0065] 3. The system according to embodiment 2, wherein:

[0066] When the actuation assembly is in the reset position, the inner lumen has a first resistance, and

[0067] When the actuating assembly is in one of the one or more expanded configurations, the inner lumen has a second resistance,

[0068] wherein the first resistance is greater than the second resistance.

[0069] 4. The system according to embodiment 2 or embodiment 3, wherein:

[0070] when the actuating assembly is in the reset position, the opening has a first diameter, and

[0071] when the actuating assembly is in one of the one or more expanded configurations, the opening has a second diameter,

[0072] wherein the first diameter is less than the second diameter.

[0073] 5. The system according to any one of embodiments 2 to 4, wherein:

[0074] the actuator is configured to transition between (a) a first material state having a relatively low rigidity mechanical property and (b) a second material state having a relatively high rigidity mechanical property in response to being heated to a temperature higher than a transition temperature, the transition temperature being higher than body temperature, and

[0075] the actuating assembly is configured to return to the reset position in response to being heated to a temperature higher than the transition temperature.

[0076] 6. The system according to any one of embodiments 2 to 5, wherein when the actuating assembly is in the reset position, adjacent protrusions among the plurality of protrusions at least partially overlap.

[0077] 7. The system according to embodiment 6, wherein the adjacent protrusions overlap by about 0.1 mm to about 2.5 mm.

[0078] 8. The system according to embodiment 6, wherein the adjacent protrusions overlap by about 0.5 mm to about 1.5 mm.

[0079] 9. The system according to any one of embodiments 2 to 8, wherein adjacent protrusions among the plurality of protrusions at least partially overlap in both the reset position and the one or more expanded positions.

[0080] 10. The system according to any one of embodiments 1 to 6, wherein adjacent protrusions among the plurality of protrusions are separated by a gap.

[0081] 11. The system according to embodiment 10, wherein the gap is at least about 0.5 mm.

[0082] 12. The system according to embodiment 10, wherein the gap is at least about 1 mm.

[0083] 13. The system according to any one of embodiments 1 to 12, wherein the membrane comprises a plurality of individual membranes, and wherein an individual membrane of the plurality of membranes envelopes an individual protrusion of the plurality of protrusions.

[0084] 14. The system according to embodiment 13, wherein each of the individual membranes comprises a first membrane portion and a second membrane portion separated at a waist, and wherein the first membrane portion envelopes the individual protrusion, and the second membrane portion extends over a part of the anchoring structure.

[0085] 15. The system according to embodiment 14, wherein the first membrane portion comprises two layers, and the second membrane portion comprises a single layer.

[0086] 16. The system according to embodiment 14, wherein the first membrane portion comprises two layers, and the second membrane portion comprises two layers.

[0087] 17. The system according to any one of embodiments 1 to 12, wherein the membrane comprises a single membrane having a plurality of membrane portions separated by a gap, and wherein an individual membrane portion of the plurality of membrane portions covers an individual protrusion of the plurality of protrusions.

[0088] 18. The system according to any one of embodiments 1 to 17, wherein the membrane is made of ePTFE.

[0089] 19. The system according to any one of embodiments 1 to 18, wherein the adjustable shunt system is an interatrial shunt system, and wherein the target anatomical structure is the interatrial septum of the heart between the left atrium and the right atrium.

[0090] 20. The system according to any one of embodiments 1 to 19, wherein the membrane is a first membrane, and wherein the system further comprises a second membrane covering the anchoring structure.

[0091] 21. The system according to embodiment 20, wherein the first membrane and the second membrane are discontinuous.

[0092] 22. The system according to embodiment 20 or embodiment 21, wherein the second membrane is made of a biocompatible and / or antithrombogenic material.

[0093] 23. The system according to any one of embodiments 1 to 22, wherein the anchoring structure is electrically connected to the actuator via a capacitor.

[0094] 24. The system according to embodiment 23, wherein the anchoring structure, the actuator, and the capacitor form an RLC circuit.

[0095] 25. A shunt system for fluidly connecting a first body region and a second body region of a patient, the system comprising:

[0096] A plurality of flaps, each flap extending between a first end portion and a second end portion, wherein the flaps are arranged in a cylindrical or conical shape to form a lumen therethrough, wherein an opening leading to the lumen is defined by the first end portion of the flap;

[0097] Wherein each individual flap of the plurality of flaps includes a corresponding individual membrane or individual membrane portion such that at least the first end portions of adjacent flaps are capable of moving relative to each other without stretching the individual membrane or individual membrane portion.

[0098] 26. The system according to embodiment 25, wherein the flaps are configured such that the flaps are capable of flexing radially inwards and / or radially outwards without stretching the membrane or membrane portion.

[0099] 27. The system according to embodiment 26, wherein the size of the opening can be adjusted by flexing the flaps radially inwards and / or radially outwards.

[0100] 28. The system according to any one of embodiments 25 to 27, wherein the membrane or membrane portion is rigid.

[0101] 29. The system according to any one of embodiments 25 to 28, wherein adjacent flaps of the plurality of flaps overlap.

[0102] 30. The system according to any one of embodiments 25 to 28, wherein adjacent flaps of the plurality of flaps are spaced apart by a gap.

[0103] 31. The system according to any one of embodiments 25 to 30, wherein the plurality of flaps includes a shape memory wire extending through the plurality of flaps.

[0104] 32. An adjustable shunt system for fluidly connecting a first body region and a second body region of a patient, the system comprising:

[0105] A plurality of membranes, the plurality of membranes arranged in a conical or cylindrical shape to form a lumen therethrough,

[0106] Each of the membranes has a perimeter that includes a first edge extending at least partially along the length of the lumen, a second edge extending at least partially along the length of the lumen, and a tip portion connecting the first edge and the second edge, wherein the width between the first edge and the second edge is less than the circumference of the lumen.

[0107] 33. The system according to embodiment 32, wherein the width between the first edge and the second edge varies along the length of each membrane.

[0108] 34. The system according to embodiment 32 or embodiment 33, wherein adjacent membranes of the plurality of membranes at least partially overlap.

[0109] 35. The system according to embodiment 32 or embodiment 33, wherein adjacent membranes of the plurality of membranes are separated by a gap.

[0110] Conclusion

[0111] Embodiments of the present disclosure may include some or all of the following components: a battery, a supercapacitor, or other suitable power source; a microcontroller, an FPGA, an ASIC, or other programmable component or system capable of storing and executing software and / or firmware for driving the operation of the implant; a memory such as RAM or ROM for storing data and / or software / firmware associated with the implant and / or its operation; wireless communication hardware such as an antenna system configured to transmit via Bluetooth, WiFi, or other protocols known in the art; an energy harvesting device, such as a coil or antenna capable of receiving and / or reading an externally provided signal, which can be used to power the device, charge the battery, initiate a read from a sensor, or for other purposes. Embodiments may also include one or more sensors, such as a pressure sensor, an impedance sensor, an accelerometer, a force / strain sensor, a temperature sensor, a flow sensor, an optical sensor, a camera, a microphone or other acoustic sensor, an ultrasonic sensor, an ECG or other heart rhythm sensor, SpO2, and other sensors suitable for measuring tissue and / or blood gas levels, a blood volume sensor, and other sensors known to those skilled in the art. Embodiments may include radiopaque and / or ultrasound-reflective portions to facilitate image-guided implantation or image-guided surgery using techniques such as fluoroscopy, ultrasound, or other imaging methods. Embodiments of the system may include a dedicated delivery catheter / system suitable for delivering the implant and / or performing the surgery. The system may include components such as guidewires, sheaths, dilators, and multiple delivery catheters. The components may be interchangeable via on-line, quick-interchange, combination, or other methods.

[0112] The above detailed description of embodiments of the present technology is not intended to be exhaustive or to limit the present technology to the precise forms disclosed above. Although specific embodiments and examples of the present technology have been described above for purposes of illustration, those skilled in the relevant art will recognize that various equivalent modifications can be made within the scope of the present technology. For example, although steps are given in a given order, alternative embodiments may perform the steps in a different order. The various embodiments described herein can also be combined to provide other embodiments. For example, although the present disclosure has been written to describe a device generally described as forming a fluid communication path between the left atrium and the right atrium, it should be understood that similar embodiments can also be used for shunts between other chambers of the heart or for shunts in other regions of the body.

[0113] Unless the context clearly requires otherwise, throughout the specification and the examples, the words "comprise", "include", etc. shall be construed in an inclusive sense, as opposed to an exclusive or exhaustive sense; that is, in the sense of "including but not limited to". As used herein, the term "connected", "coupled" or any variation thereof means any direct or indirect connection or coupling between two or more elements; the coupling or connection between elements can be physical, logical or a combination thereof. Additionally, when used in this application, the words "herein", "above", "below" and words of similar import shall refer to the application as a whole and not to any particular part of the application. Where the context permits, the use of singular or plural words in the above detailed description may also respectively include plural or singular. As used herein, the phrase "and / or" in "A and / or B" refers to A alone, B alone, and A and B. Additionally, the term "include" throughout refers to at least including the recited features, such that any greater number of the same features and / or other types of features are not excluded. It should also be understood that specific embodiments have been described herein for purposes of illustration, but various modifications can be made without departing from the present technology. Moreover, although advantages associated with certain embodiments of the present technology have been described in the context of these embodiments, other embodiments may also exhibit such advantages, and not all embodiments must exhibit such advantages to fall within the scope of the present technology. Accordingly, the present disclosure and the related art may include other embodiments not expressly shown or described herein.

Claims

1. A shunt system for fluidly connecting a first body region and a second body region of a patient, the system comprising: An anchoring structure configured to stabilize the shunt system across a target anatomical structure; And An actuation assembly coupled to the anchoring structure, wherein the actuation assembly includes— An actuator formed of one or more shape memory wires, the actuator including a plurality of protrusions that together define a cylindrical or conical shape having an inner cavity that extends through the actuator, wherein tips of the protrusions define openings leading to the inner cavity; And A membrane covering the plurality of protrusions, wherein the membrane individually covers individual ones of the plurality of protrusions, Wherein the actuation assembly is capable of selectively transitioning between at least two or more configurations, and wherein the at least two or more configurations are associated with different fluid resistances through the inner cavity.

2. The system according to claim 1, wherein the at least two or more configurations include a reset position and one or more inflated configurations.

3. The system according to claim 2, wherein: When the actuation assembly is in the reset position, the inner cavity has a first resistance, and When the actuation assembly is in one of the one or more inflated configurations, the inner cavity has a second resistance, Wherein the first resistance is greater than the second resistance.

4. The system according to claim 2, wherein: When the actuation assembly is in the reset position, the opening has a first diameter, and When the actuation assembly is in one of the one or more inflated configurations, the opening has a second diameter, Wherein the first diameter is less than the second diameter.

5. The system according to claim 2, wherein: The actuator is configured to transition between (a) a first material state having relatively low rigidity mechanical properties and (b) a second material state having relatively high rigidity mechanical properties in response to being heated to a temperature above a transition temperature, the transition temperature being above body temperature, and The actuation assembly is configured to return to the reset position in response to being heated to a temperature above the transition temperature.

6. The system according to claim 2, wherein when the actuation assembly is in the reset position, adjacent ones of the plurality of protrusions at least partially overlap.

7. The system according to claim 6, wherein the adjacent protrusions overlap by about 0.1 mm to about 2.5 mm.

8. The system according to claim 6, wherein the adjacent protrusions overlap by about 0.5 mm to about 1.5 mm.

9. The system according to claim 2, wherein adjacent ones of the plurality of protrusions at least partially overlap in both the reset position and the one or more inflated positions.

10. The system according to claim 1, wherein adjacent ones of the plurality of protrusions are separated by a gap.

11. The system according to claim 10, wherein the gap is at least about 0.5 mm.

12. The system according to claim 10, wherein the gap is at least about 1 mm.

13. The system according to claim 1, wherein the membrane comprises a plurality of individual membranes, and wherein individual membranes of the plurality of membranes envelop individual protrusions of the plurality of protrusions.

14. The system according to claim 13, wherein each of the individual membranes comprises a first membrane portion and a second membrane portion separated at a waist, and wherein the first membrane portion envelops an individual protrusion, and the second membrane portion extends over a part of the anchoring structure.

15. The system according to claim 14, wherein the first membrane portion comprises two layers, and the second membrane portion comprises a single layer.

16. The system according to claim 14, wherein the first membrane portion comprises two layers, and the second membrane portion comprises two layers.

17. The system according to claim 1, wherein the membrane comprises a single membrane having a plurality of membrane portions separated by a gap, and wherein individual membrane portions of the plurality of membrane portions cover individual protrusions of the plurality of protrusions.

18. The system according to claim 1, wherein the membrane is made of ePTFE.

19. The system according to claim 1, wherein the adjustable shunt system is an interatrial shunt system, and wherein the target anatomical structure is the interatrial septum of the heart between the left atrium and the right atrium.

20. The system according to claim 1, wherein the membrane is a first membrane, and wherein the system further comprises a second membrane covering the anchoring structure.

21. The system according to claim 20, wherein the first membrane and the second membrane are discontinuous.

22. The system according to claim 20, wherein the second membrane is made of a biocompatible and / or antithrombogenic material.

23. The system according to claim 1, wherein the anchoring structure is electrically connected to the actuator via a capacitor.

24. The system according to claim 23, wherein the anchoring structure, the actuator and the capacitor form an RLC circuit.

25. A shunt system for fluidly connecting a first body region and a second body region of a patient, the system comprising: a plurality of flaps, each flap extending between a first end portion and a second end portion, wherein the flaps are arranged in a cylindrical or conical shape to form a lumen through the flaps, wherein an opening leading to the lumen is defined by the first end portion of the flaps; wherein each individual flap of the plurality of flaps comprises a corresponding individual membrane or individual membrane portion such that at least the first end portions of adjacent flaps are movable relative to each other without stretching the individual membrane or individual membrane portion.

26. The system according to claim 25, wherein the flaps are configured such that the flaps are capable of flexing radially inwards and / or radially outwards without stretching the membrane or membrane portion.

27. The system according to claim 26, wherein the size of the opening can be adjusted by flexing the flaps radially inwards and / or radially outwards.

28. The system according to claim 25, wherein the membrane or membrane portion is rigid.

29. The system according to claim 25, wherein adjacent flaps of the plurality of flaps overlap.

30. The system according to claim 25, wherein adjacent flaps of the plurality of flaps are spaced apart by a gap.

31. The system according to claim 25, wherein the plurality of flaps includes shape memory wire extending through the plurality of flaps.

32. An adjustable shunt system for fluidly connecting a first body region and a second body region of a patient, the system comprising: a plurality of membranes arranged in a conical or cylindrical shape to form a lumen through the plurality of membranes, wherein each membrane has a perimeter including a first edge extending at least partially along the length of the lumen, a second edge extending at least partially along the length of the lumen, and a tip portion connecting the first edge and the second edge, wherein the width between the first edge and the second edge is less than the circumference of the lumen.

33. The system according to claim 32, wherein the width between the first edge and the second edge varies along the length of each membrane.

34. The system according to claim 32, wherein adjacent membranes of the plurality of membranes at least partially overlap.

35. The system according to claim 32, wherein adjacent membranes of the plurality of membranes are separated by a gap.

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