Adjustable shunting systems with selectively angled flow across septal wall

Abstract

Adjustable shunting systems providing angled flow between two body regions, such as the right atrium and the left atrium, and associated devices and methods are disclosed herein. In some embodiments, the adjustable shunting system includes an anchor structure configured to stabilize the shunting system at a target anatomical structure between the two body regions, such as a septal wall, and an actuator coupled to the anchor structure. The actuator can define a lumen extending between the two body regions at a non-orthogonal angle relative to an axis normal to a plane defined by the anchor structure and / or the anatomical part. The actuator can be selectively controllable to adjust a size of the lumen.

Description

Atorney Docket No.: 134181.8062. WO00ADJUSTABLE SHUNTING SYSTEMS WITH SELECTIVELY ANGLED FLOW ACROSS SEPTAL WALLCROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] The present application claims the benefit of U.S. Provisional Patent Application No. 63 / 695,483, filed September 17, 2024, the disclosure of which is incorporated herein by reference in its entirety.TECHNICAL FIELD

[0002] The present technology generally relates to implantable medical devices and, in particular, to adjustable shunting systems with selectively angled flow across a septal wall.BACKGROUND

[0003] Implantable shunting systems are widely used to treat a variety of patient conditions by shunting fluid from a first body region / cavity to a second body region / cavity. For example, interatrial shunting systems that shunt blood from the left atrium of the heart to the right atrium of the heart have been proposed as a treatment for heart failure in general, and heart failure with preserved ejection fraction in particular. Proposed shunting systems range in complexity from simple tube shunts to more sophisticated systems having on-board electronics, adjustable lumens, and the like. Despite the advancement of shunting system technology', designing shunting systems that can be reliably and relatively non-invasively delivered and deployed across a target structure remains a challenge.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] FIG. 1 illustrates an adjustable shunting system configured in accordance with select embodiments of the present technology.Atorney Docket No.: 134181.8062. WO00

[0006] FIG. 2A illustrates a delivery system configured in accordance with select embodiments of the present technology.

[0007] FIGS. 2B and 2C illustrate certain features of a balloon assembly of the delivery system shown in FIG. 2A.

[0008] FIGS. 3-11 are schematic cross-sectional views of various adjustable shunting systems configured in accordance with select embodiments of the present technology.DETAILED DESCRIPTION

[0009] The present technology is generally directed to medical systems that provide angled flow. In many of the embodiments described herein, an implantable medical device (e.g., an adjustable shunting system) includes one or more features to enable angled flow from one body region to another body region. For example, an adjustable shunting system can include asymmetric geometry and / or leakage paths. In another example, an adjustable shunting system can be implanted across the septal wall. As described throughout this Detailed Description, without being bound by theory, configuring the adjustable shunting system to provide angled flow is expected to optimize hemodynamics, reduce the risk of thrombosis, improve oxygenation, improve device stability, and / or the like.

[0010] 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 technology. 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 examples but are not described in detail with respect to FIGS. 1-11.

[0011] 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.Atorney Docket No.: 134181.8062. WOOO

[0012] As used herein, the use of relative terminology, 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.

[0013] FIG. 1 illustrates an adjustable shunting system 100 (“the system 100"’) in a deployed configuration and configured in accordance with select embodiments of the present technology. As described in detail below, the system 100 can be configured to shunt fluid between a first body region and a second body region when implanted in a patient (not shown). For example, the system 100 can be an interatrial shunting system configured to be implanted across a septal wall of a patient to shunt blood from the left atrium to the right atrium of the patient.

[0014] The system 100 includes an anchoring or stabilizing feature or structure 101 (“the anchor structure 101”) configured to secure the system 100 to patient tissue and / or stabilize the position of the system 100 in a desired anatomic location (e.g., across a septal wall). In the illustrated embodiment, the anchor structure 101 is a wire or filament structure (e.g., a braided or woven wire structure) having a generally annular geometry. A radially inward portion 101c of the anchor structure 101 defines a central opening or passage 103. As described in greater detail below, an actuator 104 can be coupled to the anchor structure 101 and sit at least partially within the opening 103 and / or extend from a perimeter of the radially inward portion 101c. The actuator 104 can define or at least partially define a lumen 102 extending through the opening 103, as also described in greater detail below.

[0015] The anchor structure 101 can be composed of one, tw o, three, four or more wires coupled together. For example, in the illustrated embodiment the anchor structure 101 includes a first wire portion 101a and the second wire portion 101b coupled end-to-end at a potted cap 108. The first wire portion 101a and the second wire portion 101b can be composed at least in part of a common material, such as Nitinol. However, the first wire portion 101a can further include a conductive cladding / coating (e.g.. silver or copper cladding) surrounding the Nitinol core, whereas the second wire portion 101b does not include the conductive cladding. In alternate embodiments, the conductive portion of the material can be interior to a Nitinol shell. In further variations, the conductive material may be combined with or interfaced with materials other thanAtorney Docket No.: 134181.8062. WO00Nitinol to comprise a hybrid material structure. In such embodiments, the first wire portion 101a can therefore have more favorable electrical properties to function as an inductor or antenna to wirelessly receive energy transmissions (e.g., to resistively heat the actuator 104), while the second wire portion 101b can function with more favorable mechanical properties (e.g., stronger superelasticity ) to mechanically stabilize the system 100. In some embodiments, the first wire portion 101a and the second wire portion 101b are part of the same wire. In other embodiments, the first wire portion 101a and the second wire portion 101b are parts of different wires. Additional details regarding using stabilizing / anchoring features as inductors are described in International Patent Application Publication No. WO 2022 / 081980, the disclosure of which is incorporated by reference herein in its entirety .

[0016] Regardless of its material composition, the anchor structure 101 comprises a structure having a first plurality of petals or appendages 107a and a second plurality of petals or appendages 107b. In some embodiments, the wire forming pattern of the anchor structure 101 results in immediately adjacent petals of the first petals 107a not being formed by an adjacent segment of the w ire structure forming the anchor structure 101. Instead, the wire structure can alternate between forming first petals 107a on a first side of the sy stem 100 and second petals 107b on the second side of the system 100 (e.g., the portion of the wire structure that forms an individual first petal 107a at a 12:00 position may cross to the other side of the anchor structure 101 to form an individual second petal 107b at a 3:00 position before crossing back to form another individual first petal 107a at a 5:00 position, and so on). The first plurality of petals 107a and the second plurality of petals 107b are separated by a gap (not shown).

[0017] When the system 100 is deployed across a tissue structure within a patient (e.g., a septal wall — not shown), the system 100 is configured to receive patient tissue between the first petals 107a and the second petals 107b, e.g., in the gap. Additionally, the first plurality of petals 107a and the second plurality of petals 107b can be at least partially biased toward one another such that the first petals 107a and the second petals 107b at least partially squeeze patient tissue received within the gap to secure the system 100 to patient tissue. For example, when deployed across the septal wall, the first petals 107a may reside within the left atrium, the second petals 107b may reside w ithin the right atrium, and the gap between the first petals 107a and the second petals 107b may receive a portion of the patient’s septal wall (e.g., at the fossa ovalis). The first petals 107a may be biased at least slightly toward the second petals 107b (and / or the second petals 107b may be biased at least slightly toward the first petals 107a) such that the anchor structure 101 forms a slight clamping force on the portion of the septal wall within the gap. InAtorney Docket No.: 134181.8062. WOOO some embodiments, the first petals 107a and the second petals 107b are at least partially staggered such that individual first petals 107a do not entirely overlap with individual second petals 107b. Without being bound by theory, this is expected to spread the pinching force of the system 100 (when deployed) over a larger area of the septal wall.

[0018] The anchor structure 101 can be at least partially composed of a self-expanding material such that, after being exposed to stress and strain induced by being collapsed into a delivery' tool (e.g., catheter, sheath, etc.) for delivery', it exhibits an elastic response when being deployed at body temperature. For example, the anchor structure 101 can be composed ofNitinol that has an austenite finish temperature below body temperature. Accordingly, the anchor structure 101 can automatically7deploy7or at least partially deploy (e.g., self-expand without additional input or manipulation by a clinician) from a collapsed delivery configuration (e.g., as positioned in a delivery7tool such as a catheter or sheath) toward an expanded deployed configuration when released from the delivery tool. In some embodiments, the self-expanding or superelastic properties of the anchor structure 101 may also enable the anchor structure 101 to resist plastic mechanical deformation once deployed and, accordingly, can provide a generally stable anchoring mechanism for the system 100.

[0019] In other embodiments, the anchor structure 101 can be composed of a material that is not self-expanding at body temperature. In one example, the anchor structure 101 can be composed of Nitinol that has an austenite finish temperature above body temperature. In such an example, the anchor structure 101 can be initially released from a delivery7tool in a preliminary7position (e.g., the collapsed delivery configuration, an intermediate configuration, etc.) and subsequently be heated above the austenite finish temperature to transition the shape of the anchor structure 101 toward the deployed configuration. In a second example, the anchor structure 101 can be composed of a material such as stainless steel (e.g., 316L), titanium alloy (e.g., TiAleV4), cobalt chromium alloy (e.g., L605), or polymer (e.g., PEEK). Some implementations of the second example can be self-expanding based upon a geometric configuration of the anchor structure 101. Other implementations can be manually expanded by an operator after an initial deployment using tools such as catheters, sutures, balloons, and the like.

[0020] Regardless of its material composition, in some embodiments, some or all of the anchor structure 101 can include an insulative or coating material. Examples of suitable materials include, but are not limited to, Pary lene, urethane, ePTFE, or the like. In some embodiments, theAtorney Docket No.: 134181.8062. WOOO anchor structure 101 can include multiple insulative / coating layers (e.g., Pary lene and urethane in alternating layers). The coating material can be selected to (a) improve the biocompatibility of the anchor structure 101, (b) improve the lubriciousness of the anchor structure 101, and / or (c) improve inductive properties of the anchor structure 101, as described in greater detail below. Additional details regarding anchoring features suitable for use with the system 100 are described in International Patent Application Publication No. WO 2023 / 064479. the disclosure of which is incorporated by reference herein in its entirety’.

[0021] The actuator 104 extends through the opening 103 of the anchor structure 101. As shown, the actuator 104 can be formed via one or more wires or wire-like structures 105 formed to have a plurality of projections 106 (e.g., leaflets, fingers, wings, struts, petals, lobes, etc.). The projections 106 can be formed to define a cylindrical, conical, funnel, and / or hyperboloid shape. In some embodiments, the plurality’ of projections 106 are formed from a single or common wire structure 105. In other embodiments, individual projections 106 (or fewer than all of the plurality of projections 106) of the plurality of projections 106 can be formed by separate wire structures. The proj ections 106 can be covered by one or more membranes 109. The one or more membranes 109 can be fluidically impermeable, or at least partially fluidically impermeable, to blood and / or other bodily fluids. Accordingly, the actuator 104 defines the lumen 102 through yvhich fluid can pass through the system 100. For example, when the system 100 is implanted across the septal yvall (not shoyvn), blood can floyv betyveen the left atrium and the right atrium through the actuator 104 via the lumen 102.

[0022] The actuator 104 can be adjustable to change one or more therapy parameters associated with the system 100 (e.g., flow angle, fluid resistance, lumen size, orifice size, floyv rate, etc.) to control the therapy provided to the patient via the system 100. For example, the projections 106 can be selectively flared inwardly or outyvardly to change the shape and / or size of the lumen 102. Accordingly, the actuator 104 can be transitioned through a plurality of unique positions or configurations, with each unique position or configuration providing a different fluid resistance through the lumen 102. To facilitate such movement, the one or more wires or wirelike structures 105 can be composed at least in part of a shape memory material and / or a superelastic material, such as Nitinol. Unlike the anchor structure 101, however, the yvires 105 forming the actuator 104 can have a material phase transition temperature set above body temperature. Thus, the yvires 105 may have a first material state having relatively less stiff mechanical properties at body temperature, and a second material state having relatively more stiff mechanical properties when heated above the transition temperature. The wires 105 canAtorney Docket No.: 134181.8062. WO00 therefore be more easily plastically deformed when in the first material state, and can recover the deformation when heated above the transition temperature. Additional details regarding actuators generally similar to the actuator 104 are described in International Patent Application Publication No. WO 2024 / 137843 and U.S. Patent Application Publication Nos. US 2021 / 0085935 and US 2022 / 0142652, the disclosures of which are all incorporated by reference herein in their entireties.

[0023] The present technology further provides systems and methods for percutaneously delivering and deploying adjustable shunting systems, such as the system 100 described with reference to FIG. 1, at a target location within a patient. For example, FIG. 2A illustrates a delivery system 200 for delivering and deploying an adjustable shunting system and that is configured in accordance with select embodiments of the present technology. As shown, the system 200 includes two delivery assemblies: a primary delivery assembly 210 and a secondary delivery assembly 220. The primary delivery assembly 210 includes an introducer 212 (also referred to herein as a “first introducer 212”) and an elongated shaft 216 (also referred to herein as a “first elongated shaft 216”). The first introducer 212 can include a dilator, one or more homeostasis valves, one or more introducer ports, one or more fluid access ports, and / or other features as is known for introducers. As described in greater detail below with reference to FIG. 2B, the first elongated shaft 216 can be sized and shaped to carry an adjustable shunting system collapsed into a delivery configuration. Accordingly, the primary delivery assembly 210 can also be referred to herein as an “implant delivery assembly 210.”

[0024] The secondary delivery assembly 220 also includes an introducer 222 (“a second introducer 222”) and an elongated shaft 226 (“a second elongated shaft 226”). Similar to the first introducer 212 of the first delivery assembly 210, the second introducer 222 can include a dilator, one or more homeostasis valves, one or more introducer ports, one or more fluid access ports, and / or other features as is known for introducers. The second shaft 226 can be sized and shaped to extend coaxially within the first shaft 216. For example, an outer diameter of the second shaft 226 may be less than an inner diameter of the first shaft 216. As described in greater detail below with reference to FIGS. 2B and 2C, the second shaft 226 can be coupled to an expandable member (e.g., an inflatable balloon), and can be configured to carry an inflation medium (e.g., gas or liquid) to the inflatable balloon. Accordingly, the secondary' delivery' assembly 220 can also be referred to herein as a “balloon assembly 220.”Atorney Docket No.: 134181.8062. WOOO

[0025] FIG. 2B is an enlarged cross-sectional view of a portion of the system 200 taken along the lines 2B-2B indicated in FIG. 2 A, with the elongated shaft 216 omitted for purposes of clarity. As shown, the balloon assembly 220 includes an inflatable member 224 positioned proximate a distal end portion 226a of the second elongated shaft 226. The inflatable member 224 can be selectively transitioned between a first, low-profile state (e.g., a deflated state) as shown in FIG. 2B, and a second, higher-profile state (e.g., an inflated state), not shown in FIG. 2B. This can be done by delivering an inflation medium (e.g., a liquid or a gas) through the second elongated shaft 226 and into an interior of the inflatable member 224.

[0026] In some embodiments, the balloon assembly 220 is further configured to be advanced over a guidewire. For example, FIG. 2C is a cross-sectional view of the second elongated shaft 226 taken along the lines 2C-2C indicated in FIG. 2B. As shown, the second elongated shaft 226 can include a first lumen 227 and a second lumen 228. The first lumen 227 can be fluidly coupled to the interior of the inflatable member 224 (FIG. 2B) and configured to deliver the inflation medium thereto. The second lumen 228 can extend through the inflatable member 224 and terminate at a tip 229 (FIG. 2B) of the balloon assembly 220. Accordingly, the second lumen 228 can be configured to receive a guidewire (not shown), enabling the balloon assembly 220 to be advanced over a guidewire. As set forth above, the delivers’ system 200 can be sized and shaped to facilitate delivery of an adjustable shunting system to a target implant location.

[0027] FIGS. 3-8 are schematic cross-sectional views of various adjustable shunting systems with one or more features to provide angled flow and configured in accordance with select embodiments of the present technology. It is appreciated that the various adjustable shunting systems described below can have features similar to those of the system 100 described above with reference to FIG. 1. It is also appreciated that the various actuators disclosed herein can adjust the angle of fluid flow by, for example, adjusting the position and / or orientations of projections during implantation and / or in-situ. Also, while FIGS. 3-8 focus on select features to provide angled flow, a person of ordinary skill in the art will understand that these two or more of these features can be combined in a single embodiment.

[0028] Referring first to FIG. 3, an adjustable shunting system 300 (“the system 300”) includes an anchor structure 301 (e.g., the anchor stmcture 101) and an actuator 304 (e.g., the actuator 304) coupled to the anchor structure 301. The anchor structure 301 can include a plurality of first petals 307a (e.g.. the first petals 107a) and a plurality' of second petals 307bAtorney Docket No.: 134181.8062. WOOO(e.g., the second petals 107b). When the system 300 is deployed across a patient’s septal wall S, as shown, the first petals 307a reside within the left atrium LA, the second petals 307b reside within the right atrium RA, and the gap between the first petals 307a and the second petals 307b receives a portion of the septal wall S (e.g., at the fossa ovalis).

[0029] The actuator 304 can include a plurality of projections that extend at an angle into the RA and define a lumen 302 (e.g., the lumen 102) for controlling blood flow therethrough. In particular, the actuator 304 can include one or more projections on or toward the upper side of the septal wall S (“the upper projections 306a”) and one or more projections on or toward the lower side of the septal wall S (“the lower projections 306b”). In the illustrated embodiment, the upper projections 306a, which may extend downward, are longer than the lower projections 306b, which may extend upward. In some embodiments, the upper projections 306a and the lower projections 306b can be set to have different lengths by arranging their corresponding wire portions to have different geometries and / or sizes in the deployed configuration. Therefore, as blood flows through the lumen 302, which extends at a non-orthogonal angle relative to the axis A- A, the upper projections 306a guide the blood downward more so than the lower projections 306b guide the blood upward. This results in a net downward, and thus angled, flow across the system 300.

[0030] Referring next to FIG. 4, an adjustable shunting system 400 (“the system 400”) includes an anchor structure 401 and an actuator 404 coupled to the anchor structure 401. The actuator 404 can include one or more upper projections 406a and one or more lower projections 406b among a plurality of projections that define a lumen 402 for controlling blood flow therethrough. In the illustrated embodiment, the upper projections 406a extend toward the RA at a sharper angle than the lower projections 406b extend upward. For example, relative to an axis A-A normal to a plane P-P (FIG. 3) defined by the anchor structure 301 and / or the septal wall S, the upper projections 406a are at a greater angle than the lower projections 406b. Alternatively, the lower projections 406b can extend generally perpendicular to the septal w all S or downward toward the RA. In some embodiments, the upper projections 406a and the lower projections 406b can be configured to extend at different angles (e.g., in different directions) by shape setting their corresponding wire portions differently. In some embodiments, the upper projections 406a and the lower projections 406b can be configured to extend at different angles by using different materials. For example, the upper projections 406a can be composed of shape memory material(s) and / or superelastic material(s) that deform into the curved or angled shape once deployed, and the lower projections 406b can be composed of superelastic material(s) thatAtorney Docket No.: 134181.8062. WO00 resist plastic mechanical deformation once deployed. In another example, the upper projections 406a can be composed of superelastic material(s) that have an at least partially curved, prefixed shape that retains the curvature once deployed. Therefore, as blood flows through the lumen 402, the upper projections 406a guide the blood downward more so than the lower projections 406b guide the blood upward. This results in a net downward, and thus angled, flow' across the system 400.

[0031] Referring next to FIG. 5, an adjustable shunting system 500 (“the system 500”) includes an anchor structure 501 and an actuator 504. The actuator 504 can include one or more upper projections 506a and one or more lower projections 506b among a plurality of projections that define a lumen 502 for controlling blood flow therethrough. In the illustrated embodiment, the system 500 further includes an attachment component 520 coupling the upper projections 506a to the anchor structure 501. The attachment component 520 can include one or more features (e.g., geometry, size, orientation, thickness, angle, etc.) that enable the upper projections 506a to extend downward at a different angle than the lower projections 506b extend upward, even if, for example, the upper projections 506a and the lower projections 506b have the same size, geometry, materials, shape setting, and / or the like. In some embodiments, the attachment component 520 can be composed of superelastic material(s) that resist deformation and retain their shape upon deployment. Therefore, as blood flows through the lumen 502, the upper projections 506a guide the blood downward more so than the lower projections 506b guide the blood upward. This results in a net downw ard, and thus angled, flow across the system 500.

[0032] Referring next to FIG. 6, an adjustable shunting system 600 (“the system 600”) includes an anchor structure 601 and an actuator 604. The anchor structure 601 can include a plurality of first petals 607a and a plurality of second petals 607b that engage the septal wall S. The actuator 604 can include one or more upper projections 606a and one or more lower projections 606b among a plurality of projections that define a lumen 602 for controlling blood flow therethrough. In the illustrated embodiment, the radially inward portion 601c of the anchor structure 601 is at a non-orthogonal angle relative to first and second petals 607a, 607b (and to the septal wall S), thus defining a central opening or passage 603 that is also angled. The angled form factor of the radially inward portion 601c of the anchor structure 601 enable the upper projections 606a and the lower projections 506b to define the lumen 602 that is also angled, even if, for example, the upper projections 606a and the lower projections 606b have the same size, geometry, materials, shape setting, and / or the like. Therefore, as blood flows through the lumen 602, the upper projections 606a guide the blood downward more so than the lower projectionsAtorney Docket No.: 134181.8062. WO00606b guide the blood upward. This results in a net downward, and thus angled, flow across the system 600.

[0033] Referring next to FIG. 7, an adjustable shunting system 700 (“the system 700'’) includes an anchor structure 701 and an actuator 704. The anchor structure 701 can include a plurality of first petals 707a and a plurality of second petals 707b that engage the septal wall S. The actuator 704 can include one or more upper projections 706a and one or more lower projections 706b among a plurality' of projections that define a lumen 702 for controlling blood flow therethrough. In the illustrated embodiment, the second petals 707b at the upper portion of the septal wall S extend farther into the right atrium RA compared to, for example, the second petals 607b shown in FIG. 6. Alternatively or additionally, the first petals 707a at the lower portion of the septal wall S can extend farther into the left atrium LA compared to, for example, the first petals 607a shown in FIG. 6. Also, the radially inward portion 701c of the anchor structure 701 is at a non-orthogonal angle relative to first and second petals 707a, 707b (and to the septal wall S), thus defining a central opening or passage 703 that is also angled. The asymmetric form factor of the anchor structure 701 enables the upper projections 706a and the lower projections 706b to define the lumen 702 that is also angled, even if, for example, the upper projections 706a and the lower projections 706b have the same size, geometry, materials, shape setting, and / or the like. Therefore, as blood flows through the lumen 702, the upper projections 706a guide the blood downward more so than the lower projections 706b guide the blood upward. This results in a net downward, and thus angled, flow across the system 700.

[0034] It will be appreciated that in the illustrated embodiments of FIGS. 3-7, the projections are angled toward and adjustable at or near the right atrium RA such that the inflow from the left atrium LA is substantially orthogonal to the septal wall S while the outflow to the right atrium RA is angled. This can help minimize the amount of hardware positioned within the left atrium LA, which may increase the risk of a stroke. However, in some embodiments, the projections can be angled toward and adjustable at or near the left atrium LA instead. As illustrated in FIG. 8, an adjustable shunting system 800 (“the system 800”) includes an anchor structure 801 and an actuator 804. The actuator 804 can include one or more upper projections 806a and one or more lower projections 806b among a plurality of projections that define a lumen 802 for controlling blood flow' therethrough. In the illustrated embodiment, the upper projections 806a and the lower projections 806b face the left atrium LA, and the system 800 further includes an angled channel 820 extending into the right atrium RA. The angled channel 820 can remain angled (e.g., downward) when deployed. In some embodiments, the angledAtorney Docket No.: 134181.8062. WOOO channel 820 includes superelastic materials that can retain their shape. Therefore, as blood flows through the lumen 802, the angled channel 820 guides the blood downward and results in a net downward, and thus angled, flow across the system 800.

[0035] In some embodiments, an adjustable shunting system can have alternative or additional features to achieve angled flow across the septal wall S. For example, portions of the adjustable shunting system (e.g., one or more of the projections 106, portions of the membrane 109 covering the projections 106) can be removed or omitted to create a leak in the actuator 104 that directs flow in a desired, angled manner. In another example, different portions of the membrane 109 at different ones of the proj ections can have different permeability and / or textures to influence the flow to be angled (e.g., the second projections can be textured to slow down flow near the lower portion of the septal wall S). In another example, the adjustable shunting system can include additional components, such as angled flow directors, that direct flow downward. Such additional components may be coupled to the actuator. In another example, the adjustable shunting system can include additional components, such as a pop-off valve, that can facilitate self-adjustment of the outflow' angle and / or volumetric flow rate based on one or more factors, such as the flow rate through the lumen. In yet another example, the adjustable shunting system can include additional components, such as canisters, that can partially block flow and / or prevent portions of the actuator from opening in a particular direction (e.g., prevent the actuator from opening towards the upper portion of the septal w all S). Such canisters can have a sail or foil thereon that goes down over the lumen.

[0036] FIGS. 9-11 are schematic cross-sectional views of various adjustable shunting systems implantable in a manner to provide angled flow and configured in accordance with select embodiments of the present technology. It is appreciated that the various adjustable shunting systems described below' can have features similar to those of the system 100 described above with reference to FIG. 1. Also, while FIGS. 9-11 focus on select implantation methods to provide angled flow', a person of ordinary' skill in the art w ill understand that these two or more of these methods can be combined in a single embodiment.

[0037] Referring first to FIG. 9, an adjustable shunting system 900 (“the system 900"’) includes an anchor structure 901 and an actuator 904. The actuator 904 can include one or more upper projections 906a and one or more lower projections 906b among a plurality7of projections that define a lumen 902 for controlling blood flow7therethrough. As discussed above with reference to FIG. 2, an inflatable member can assist the deployment of an adjustable shuntingAtorney Docket No.: 134181.8062. WO00 system. In the illustrated embodiment, an inflatable member 924 (e.g., the inflatable member 224) can be used to provide angled flow. In some embodiments, the inflatable member 924 is sized and / or shaped such that when deploying the system 900 across the septal wall S, the upper projections 906a and the lower projections 906b extend at different angles to provide angled flow through the lumen 902. In some embodiments, the inflatable member 924 is inserted into the lumen 902 at an angle such that when deploying the system 900 across the septal wall S, the upper projections 906a and the lower projections 906b extend at different angles to provide angled flow through the lumen 902 (e.g., the inflatable member 924 can be selected to be sufficiently stiff for this purpose). In some embodiments, the inflatable member 924 is asymmetric such that, for example, the inflatable member 924 is inflated more toward the lower projections 906b than toward the upper projections 906, allowing the upper projections 906a and the lower proj ections 906b to extend at different angles to provide angled flow through the lumen 902.

[0038] Referring next to FIG. 10, an adjustable shunting system 1000 (‘'the system 1000”) includes an anchor structure 1001 and an actuator 1004. The actuator 1004 can include one or more upper projections 1006a and one or more lower projections 1006b among a plurality of projections that define a lumen 1002 for controlling blood flow therethrough. In the illustrated embodiment, a catheter 1020 including one or more prongs, grippers, hooks, and / or the like (“the prongs 1022”) is used to provide angled flow across the septal wall. More specifically, the prongs 1022 can engage the upper projections 1006a and / or the lower projections 1006b to position and / or orient them in a desired manner. For example, the prongs 1022 can softly grip select ones of the upper projections 1006a and / or the lower projections 1006b and pull them into a desired position such as to provide angled flow through the lumen 1002. The prongs 1022 can be static (e.g., hooks with a fixed shape) or actuatable (e.g., movable grippers). In some embodiments, the upper projections 1006a and / or the lower projections 1006b can include one or more features to facilitate engagement by the prongs 1022, such as positioning nubs.

[0039] Referring next to FIG. 11, an adjustable shunting system 1100 (“the system 1100”) includes an anchor structure 1 101 and an actuator 1104. The actuator 1104 can include one or more upper projections 1106a and one or more lower projections 1106b among a plurality of projections that define a lumen 1102 for controlling blood flow' therethrough. In the illustrated embodiment, the system 1100 is deployed in a manner that changes the curvature of the septal wall S. The system 1100 can be sufficiently stiff to alter the angle of the septal wall S. which may be relatively thin and flexible. In some embodiments, the anchor structure 1101 isAtorney Docket No.: 134181.8062. WOOO configured to have different anchoring or cinching pressure at different points on the septal wall S. In some embodiments, the gap between first and second petals 1107a. 1107b at the upper portion of the septal wall S is different from the gap between the first and second petals 1107a, 1107b at the lower portion of the septal wall S. In some embodiments, the first and second projections 1106a, 1106b face the left atrium LA (e.g., as illustrated in FIG. 8), the second petals 1107b at the upper portion of the septal wall S extend farther into the right atrium RA (e.g.. as illustrated in FIG. 7), and / or the second projections 1106b are longer to achieve reorientation of the septal wall S. In some embodiments, the system 1100 omits the actuator 1104, and the anchor structure 1101 can be sufficient to achieve reorientation or angling of the septal wall S in a desired manner. In some embodiments, the anchor structure 1101 is shape set in a specific way to achieve curving of the septal wall S. By changing the curvature or angle of the septal wall S, the system 1100 can provide angled flow through the lumen 1102.

[0040] Referring to FIGS. 3-11 together, it will be appreciated that various techniques can be employed to ensure that the adjustable shunting system is deployed at the septal wall S in the correct orientation. For example, if the adjustable shunting system has upper projections that are longer than the lower projections, the adjustable shunting system can be implanted such that the longer upper projections are positioned adjacent or toward the upper portion of the septal wall (as illustrated in FIG. 3). Once the adjustable shunting system is implanted, the clamping force provided by the anchor structure can be sufficient to maintain the initial orientation.

[0041] Features of the adjustable shunting lumen and / or the manner of implantation can be customized for the particular patient. In some embodiments, the size and / or angle of the adjustable shunting lumen is optimized for the particular patient. For example, the angle can be adjusted for achieving consistency with existing flow patterns or other hemodynamic factors, which can differ between different patients. The angle can be selected based on the patient’s hemodynamics as observed under ultrasound (e.g., 3D doppler) or other visualization instruments, and / or with artificial intelligence algorithms. In some embodiments, the implantation location of the adjustable shunting lumen is selected based on the natural angles, varying thicknesses, and / or other features of the septal wall, which can be different for different patients. For example, a deployment spot can be selected to achieve desired angle of the flow through the lumen.

[0042] It will be appreciated that the various features and implantation methods discussed herein can independently achieve angled flow across the septal wall. For example, an asymmetricAtorney Docket No.: 134181.8062. WO00 inflatable member can be used, as discussed above with reference to FIG. 9, without any of the features discussed above with reference to FIGS. 3-8. Alternatively, two or more of the various features and / or implantation methods discussed herein can be combined in a single embodiment to achieve angled flow across the septal wall. For example, the upper and lower projections of an adjustable shunting system can have different lengths (as illustrated in FIG. 3), the radially inward portion of the anchor structure can be at a non-orthogonal angle relative to the first and second petals 707a, 707b and to the septal wall S (as illustrated in FIG. 7), and a catheter with prongs can be used to further adjust the angle of the projections (as illustrated in FIG. 10).Examples

[0043] 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 manner.1. An adjustable shunting system for providing angled flow between a first body region and a second body region of a patient, the adjustable shunting system comprising: an anchor structure configured to stabilize the adjustable shunting system at a target anatomical structure between the first body region and the second body region; and an actuator having a first section operably coupled to the anchor structure and a second section configured to at least partially extend into the second body region, wherein the second section at least partially defines a lumen, and wherein the actuator is selectively and repeatably adj ustable in vivo to change an angle of fluid flow through the second section to at least two different non-orthogonal angles relative to a plane defined by the anchor structure.2. The adjustable shunting system of example 1, wherein the second section of the actuator is composed of a shape memory material shape-set to curve.3. The adjustable shunting system of example 1 or example 2, wherein the second section of the actuator includes:Atorney Docket No.: 134181.8062. WOOO one or more upper projections configured to be positioned adjacent to an upper portion of the target anatomical structure; and one or more lower projections configured to be positioned adjacent to a lower portion of the target anatomical structure, wherein each of the one or more upper projections and the one or more lower projections is configured to extend into the first body region.4. The adjustable shunting system of example 3, wherein individual ones of the one or more upper projections are longer than individual ones of the one or more lower projections.5. The adjustable shunting system of example 3 or example 4, wherein individual ones of the one or more upper projections are angled downward by a first angle relative to an axis normal to the plane defined by the anchor structure, wherein individual ones of the one or more lower projections are angled upward by a second angle relative to the axis, and wherein the second angle is less than the first angle.6. The adjustable shunting system of any of examples 3-5, further comprising an attachment component coupled between the anchor structure and the one or more upper projections, wherein the attachment component is shaped to extend at a non-orthogonal angle relative to the plane defined by the anchor structure.7. The adjustable shunting system of any of examples 3-6, wherein individual ones of the one or more upper projections extend farther into the first body region or the second body region than individual ones of the one or more lower projections.8. The adjustable shunting system of any of examples 3-7, wherein the one or more upper projections are composed of a superelastic material shape-set to curve, and wherein the one or more lower projections are composed of a superelastic material configured to resist deformation upon deployment at the target anatomical structure.9. The adjustable shunting system of any of examples 1-8, wherein the actuator includes a radially inward portion defining the lumen and oriented at a non-orthogonal angle relative to a plane defined by the anchor structure.Atorney Docket No.: 134181.8062. WOOO10. The adjustable shunting system of any of examples 1-9, further comprising an angled channel coupled to the anchor structure and extending away from the actuator and into the first body region or the second body region.11. The adjustable shunting system of any of examples 1-10, wherein the anchor structure is configured to alter an orientation of the target anatomical structure.12. The adjustable shunting system of any of examples 1-11, wherein the first body region comprises a right atrium, wherein the second body region comprises a left atrium, and wherein the target anatomical structure comprises a septal wall.13. The adjustable shunting system of any of examples 1-12, wherein the actuator is configured to adjust the angle of fluid flow based, at least in part, on hemodynamics of the patient.14. The adjustable shunting system of any of examples 1-13, wherein the actuator is further configured to adjust a size of the lumen.15. A method for providing angled flow between a first body region and a second body region of a patient, the method comprising: implanting an adjustable shunting system at a target anatomical structure between the first body region and the second body region, wherein implanting the adjustable shunting system comprises stabilizing, via an anchor structure of the adjustable shunting system, the adjustable shunting system at the target anatomical structure; and adjusting, via an actuator of the adjustable shunting system, an angle of fluid flow through at least a region of the lumen.16. The method of example 15, wherein implanting the adjustable shunting system comprises inflating an inflatable member within the lumen while the inflatable member is oriented at a non-orthogonal angle relative to a plane defined by the anchor structure such that the angle of fluid flow through the lumen is non-orthogonal relative to a plane defined by the anchor structure.Atorney Docket No.: 134181.8062. WOOO17. The method of example 15 or example 16, wherein implanting the adjustable shunting system comprises inflating an asymmetric inflatable member within the lumen such that upper projections of the actuator extend at a different angle relative to a plane defined by the anchor structure than lower proj ections of the actuator.18. The method of any of examples 15-17. wherein adjusting comprises adjusting the angle of fluid flow through the lumen based, at least in part, on hemodynamics of the patient.19. The method of any of examples 15-18, further comprising adjusting, via a catheter having a prong, an orientation of at least one of upper projections of the actuator or lower projections of the actuator such that the upper projections extend into the first body region or the second body region at a different angle than the lower projections.20. The method of any of examples 15-19. wherein implanting comprises altering an orientation of the target anatomical structure relative to the patient.Conclusion

[0044] Embodiments of the present disclosure may include some or all of the following components: a battery7, supercapacitor, or other suitable power source; a microcontroller, FPGA, ASIC, or other programmable component or system capable of storing and executing software and / or firmware that drives operation of an implant; memory such as RAM or ROM to store data and / or software / firmware associated with an 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; energy harvesting means, for example a coil or antenna which is capable of receiving and / or reading an externally-provided signal which may be used to power the device, charge a battery, initiate a reading from a sensor, or for other purposes. Embodiments may also include one or more sensors, such as pressure sensors, impedance sensors, accelerometers, force / strain sensors, temperature sensors, flow sensors, optical sensors, cameras, microphones or other acoustic sensors, ultrasonic sensors, ECG or other cardiac rhythm sensors, SpO2 and other sensors adapted to measure tissue and / or blood gas levels, blood volume sensors, and other sensors known to those who are skilled in the art. Embodiments may include portions that are radiopaque and / or ultrasonically reflective to facilitate image-guided implantation or image guided procedures using techniques such as fluoroscopy, ultrasonography,Atorney Docket No.: 134181.8062. WOOO or other imaging methods. Embodiments of the system may include specialized delivery' catheters / sy stems that are adapted to deliver an implant and / or carry out a procedure. Systems may include components such as guidewires, sheaths, dilators, and multiple delivery' catheters. Components may be exchanged via over-the-wire, rapid exchange, combination, or other approaches.

[0045] The above detailed description of embodiments of the technology7are not intended to be exhaustive or to limit the technology7to the precise forms 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. For example, although steps are presented in a given order, alternative embodiments may perform steps in a different order. The various embodiments described herein may also be combined to provide further embodiments. For example, although this disclosure has been written to describe devices that are generally described as being used to create a path of fluid communication between the left atrium and the right atrium, it should be appreciated that similar embodiments could be utilized for shunts between other chambers of the heart or for shunts in other regions of the body.

[0046] Unless the context clearly requires otherwise, throughout the description and the examples, the words “comprise,” “comprising,” and the like are to be construed in an inclusive sense, as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to.” As used herein, the terms “connected,” “coupled,” or any variant thereof, means any connection or coupling, either direct or indirect, between two or more elements; the coupling of connection between the elements can be physical, logical, or a combination thereof. Additionally, the words “herein.” “above,” “below,” and words of similar import, when used in this application, shall refer to this application as a whole and not to any particular portions of this application. Where the context permits, words in the above Detailed Description using the singular or plural number may also include the plural or singular number respectively. As used herein, the phrase “and / or” as in “A and / or B” refers to A alone, B alone, and A and B. 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 ty pes of other features are not precluded. It will also be appreciated that specific embodiments have been described herein for purposes of illustration, but that various modifications may be made without deviating from the technology. Further, while advantages associated with some embodiments of the technology have been described in the context of those embodiments, other embodimentsAtorney Docket No.: 134181.8062. WOOO 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

Atorney Docket No.: 134181.8062. WOOOCLAIMSWhat is claimed is:

1. An adjustable shunting system for providing angled flow between a first body region and a second body region of a patient, the adjustable shunting system comprising: an anchor structure configured to stabilize the adjustable shunting system at a target anatomical structure between the first body region and the second body region; and an actuator having a first section operably coupled to the anchor structure and a second section configured to at least partially extend into the second body region, wherein the second section at least partially defines a lumen, and wherein the actuator is selectively and repeatably adj ustable in vivo to change an angle of fluid flow through the second section to at least two different non-orthogonal angles relative to a plane defined by the anchor structure.

2. The adjustable shunting system of claim 1. wherein the second section of the actuator is composed of a shape memory material shape-set to curve.

3. The adjustable shunting system of claim 1, wherein the second section of the actuator includes: one or more upper projections configured to be positioned adjacent to an upper portion of the target anatomical structure; and one or more lower projections configured to be positioned adjacent to a lower portion of the target anatomical structure, wherein each of the one or more upper projections and the one or more lower projections is configured to extend into the first body region.

4. The adjustable shunting system of claim 3, wherein individual ones of the one or more upper projections are longer than individual ones of the one or more lower projections.

5. The adjustable shunting system of claim 3, wherein individual ones of the one or more upper projections are angled downward by a first angle relative to an axis normal to theAtorney Docket No.: 134181.8062. WOOO plane defined by the anchor structure, wherein individual ones of the one or more lower projections are angled upward by a second angle relative to the axis, and wherein the second angle is less than the first angle.

6. The adjustable shunting system of claim 3, further comprising an attachment component coupled between the anchor structure and the one or more upper projections, wherein the attachment component is shaped to extend at a non-orthogonal angle relative to the plane defined by the anchor structure.

7. The adjustable shunting system of claim 3. wherein individual ones of the one or more upper projections extend farther into the first body region or the second body region than individual ones of the one or more lower projections.

8. The adjustable shunting system of claim 3, wherein the one or more upper projections are composed of a superelastic material shape-set to curve, and wherein the one or more lower projections are composed of a superelastic material configured to resist deformation upon deployment at the target anatomical structure.

9. The adjustable shunting system of claim 1, wherein the actuator includes a radially inward portion defining the lumen and oriented at a non-orthogonal angle relative to a plane defined by the anchor structure.

10. The adjustable shunting system of claim 1, further comprising an angled channel coupled to the anchor structure and extending away from the actuator and into the first body region or the second body region.

11. The adjustable shunting system of claim 1, wherein the anchor structure is configured to alter an orientation of the target anatomical structure.

12. The adjustable shunting system of claim 1, wherein the first body region comprises a right atrium, wherein the second body region comprises a left atrium, and wherein the target anatomical structure comprises a septal wall.Atorney Docket No.: 134181.8062. WOOO13. The adjustable shunting system of claim 1, wherein the actuator is configured to adjust the angle of fluid flow based, at least in part, on hemodynamics of the patient.

14. The adjustable shunting system of claim 1, wherein the actuator is further configured to adjust a size of the lumen.

15. A method for providing angled flow between a first body region and a second body region of a patient, the method comprising: implanting an adjustable shunting system at a target anatomical structure between the first body region and the second body region, wherein implanting the adjustable shunting system comprises stabilizing, via an anchor structure of the adjustable shunting system, the adjustable shunting system at the target anatomical structure; and adjusting, via an actuator of the adjustable shunting system, an angle of fluid flow through at least a region of the lumen.

16. The method of claim 15, wherein implanting the adjustable shunting system comprises inflating an inflatable member within the lumen while the inflatable member is oriented at a non-orthogonal angle relative to a plane defined by the anchor structure such that the angle of fluid flow through the lumen is non-orthogonal relative to a plane defined by the anchor structure.

17. The method of claim 15, wherein implanting the adjustable shunting system comprises inflating an asymmetric inflatable member within the lumen such that upper projections of the actuator extend at a different angle relative to a plane defined by the anchor structure than lower projections of the actuator.

18. The method of claim 15, wherein adjusting comprises adjusting the angle of fluid flow through the lumen based, at least in part, on hemodynamics of the patient.

19. The method of claim 15, further comprising adjusting, via a catheter having a prong, an orientation of at least one of upper projections of the actuator or lower projections ofAtorney Docket No.: 134181.8062. WOOO the actuator such that the upper projections extend into the first body region or the second body region at a different angle than the lower projections.

20. The method of claim 15, wherein implanting comprises altering an orientation of the target anatomical structure relative to the patient.

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