WO2023063961A1 - Flow control assemblies with adjustable lumens for adjustable shunting systems, and associated systems, methods and devices - Google Patents

Flow control assemblies with adjustable lumens for adjustable shunting systems, and associated systems, methods and devices Download PDF

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Publication number
WO2023063961A1
WO2023063961A1 PCT/US2021/055258 US2021055258W WO2023063961A1 WO 2023063961 A1 WO2023063961 A1 WO 2023063961A1 US 2021055258 W US2021055258 W US 2021055258W WO 2023063961 A1 WO2023063961 A1 WO 2023063961A1
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WO
WIPO (PCT)
Prior art keywords
adjustable
flow control
control assembly
end portion
housing
Prior art date
Application number
PCT/US2021/055258
Other languages
French (fr)
Inventor
Robert Chang
Amr Salahieh
Claudio Argento
Michael Drews
Katherine SAPOZHNIKOV
Original Assignee
Shifamed Holdings, Llc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Shifamed Holdings, Llc filed Critical Shifamed Holdings, Llc
Priority to PCT/US2021/055258 priority Critical patent/WO2023063961A1/en
Publication of WO2023063961A1 publication Critical patent/WO2023063961A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027Type of occlusion
    • A61B17/12036Type of occlusion partial occlusion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M27/00Drainage appliance for wounds or the like, i.e. wound drains, implanted drains
    • A61M27/002Implant devices for drainage of body fluids from one part of the body to another
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00367Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • A61B2017/00407Ratchet means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00867Material properties shape memory effect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007Methods or devices for eye surgery
    • A61F9/00781Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment

Definitions

  • the present technology generally relates to implantable medical devices and, in particular, to adjustable shunting systems and associated methods for selectively controlling fluid flow between a first body region and a second body region of a patient.
  • Implantable shunting systems are widely used to treat a variety of patient conditions by shunting fluid from a first body region/cavity to a second body region/cavity.
  • the flow of fluid through the shunting systems is primarily controlled by the pressure gradient across the shunt and the physical characteristics of the flow path defined through the shunt (e.g., the resistance of the shunt lumen(s)).
  • most shunting systems have a single static flow path that is not adjustable. Accordingly, one challenge with conventional shunting systems is selecting the appropriate size shunt for a particular patient. A shunt that is too small may not provide enough therapy to the patient, while a shunt that is too large may create new issues in the patient.
  • FIGS. 1A-1D are schematic illustrations of a flow control assembly configured in accordance with various embodiments of the present technology.
  • FIG. 2A is a perspective view of a flow control assembly configured in accordance with various embodiments of the present technology.
  • FIG. 2B is an enlarged perspective view of a portion of the flow control assembly of FIG. 2A.
  • FIG. 3 is a partially schematic top side of an actuation mechanism for adjusting a flow control assembly and configured in accordance with various embodiments of the present technology.
  • FIG. 4 is a perspective view of another flow control assembly configured in accordance with various embodiments of the present technology.
  • the present technology is generally directed to adjustable shunting systems, including adjustable shunting systems with flow control assemblies having adjustable lumens.
  • the flow control assembly can include a body that defines a lumen.
  • the body can include an adjustable portion having an inner dimension (e.g., width, diameter, etc.) that is proportional to a fluid resistance of the lumen.
  • the flow control assembly can be configured to transition between one or more configurations, and each configuration can correspond to a different inner dimension of the adjustable portion.
  • the flow control assembly can be rotation-based, such that transitioning the flow control assembly between the one or more configurations can include rotating at least part of the flow control assembly.
  • the flow control assembly in response to rotation, can be configured to twist or constrict the adjustable portion inwardly (e.g., toward a longitudinal axis of the body) to reduce the inner dimension of the adjustable portion. Reducing the inner dimension of the adjustable portion can increase the fluid resistance of the flow control assembly.
  • shunting systems having flow control assemblies configured in accordance with embodiments of the present technology can include a single lumen defining a single flow path that is adjustable to provide a range of fluid resistances.
  • adjustable shunting systems including flow control assemblies in accordance with embodiments of the present technology are expected to provide a titratable therapy while still being relatively small and relatively easy to implement.
  • flow control assemblies configured in accordance with embodiments of the present technology are expected to exhibit a greater degree of adjustability compared to many shunting systems.
  • the rotation-based transitioning of the flow control assemblies described herein can result in incremental or gradual changes to the inner dimension of the adjustable portion.
  • Such incremental changes can allow the flow control assembly to be adjusted between a greater number of different fluid resistances compared to many shunting systems, particularly in embodiments in which flow the flow rate through the system is relatively high.
  • the present technology may also provide additional advantageous characteristics not expressly described herein.
  • the systems described herein can be used to treat diseases characterized by increased pressure and/or fluid build-up, including but not limited to heart failure (e.g., heart failure with preserved ejection fraction, heart failure with reduced ejection fraction, etc.), pulmonary failure, renal failure, hydrocephalus, and the like.
  • heart failure e.g., heart failure with preserved ejection fraction, heart failure with reduced ejection fraction, etc.
  • pulmonary failure pulmonary failure
  • renal failure e.g., pulmonary failure, renal failure, hydrocephalus, and the like.
  • the systems described herein may be applied equally to shunting other fluid, such as blood or cerebrospinal fluid, between the first body region and the second body region.
  • FIGS. 1A-1D schematically illustrate a flow control assembly 100 (“the assembly 100”) configured in accordance with various embodiments of the present technology.
  • the assembly 100 can be incorporated into an adjustable shunting system and used to selectively adjust or titrate the fluid resistance through the shunting system.
  • the assembly 100 can be incorporated into any suitable shunting system having a lumen, such as any of the adjustable shunting systems incorporated by reference herein, and/or any other suitable adjustable shunting system.
  • the assembly 100 can be positioned at least partially around (e.g., external to, aligned with, about, containing etc.) a fluid channel or conduit of a shunting system.
  • the assembly 100 can include a flexible and impermeable membrane.
  • the assembly 100 can include a generally elongate body 104 (which can also be referred to as a shunting element, a conduit, or the like) having a first end portion 104a, a second end portion 104b opposite the first end portion 104a, and an adjustable portion 104c extending between the first end portion 104a and the second end portion 104b.
  • the adjustable portion 104c can define an inner contour or shape of the body 104 having one or more dimensions(e.g., width, diameter, etc.) of the body 104.
  • the adjustable portion 104c can have a first end 106a proximate and/or coupled to the first end portion 104a of the body 104 and a second end 106b proximate and/or coupled to the second end portion 104b of the body 104. Accordingly, the first end 106a of the adjustable portion 104c can move (e.g., rotate) in concert with the first end portion 104a of the body 104 and/or the second end 106b of the adjustable portion 104c can move (e.g., rotate) in concert with the second end portion 104b of the body 104.
  • the body 104 can be partially or fully hollow, such that the body 104 can define a lumen 105 through which fluid 101 (e.g., aqueous) can flow.
  • fluid 101 e.g., aqueous
  • the fluid 101 can enter the body 104 via the second end portion 104b, flow through the adjustable portion 104c, and exit the body 104 via the first end portion 104a.
  • fluid can flow through the body 104 in reverse, e.g., entering the body 104 via the first end portion 104a and exiting the body 104 via the second end portion 104b.
  • the body 104 has a circular cross-sectional shape
  • the body 104 can have an oval, triangular, square, rectangular, pentagonal, hexagonal, rectilinear, curvilinear, and/or any other suitable cross-sectional shape.
  • the first end portion 104a, the second end portion 104b, and the adjustable portion 104c of the body 104 have a same cross-sectional shape
  • one or more of the first end portion 104a, the second end portion 104b, and/or the adjustable portion 104c of the body 104 can have a different cross-sectional shape.
  • the adjustable portion 104c in FIGS. 1A-1D can include a plurality of longitudinal elements 108 (e.g., spines, filaments, fibers, etc.) that are spaced apart from each other.
  • the longitudinal elements 108 can be covered by a flexible and impermeable membrane (not shown) or the like such that the fluid 101 that flows through the adjustable portion 104c is generally or substantially prevented from leaking from the assembly 100 (e.g., at least at locations along the adjustable portion 104c).
  • the longitudinal elements 108 can at least partially define a contour, profile, and/or minimum dimension of a portion (e.g., the adjustable portion 104c) of the body 104.
  • the longitudinal elements 108 can define a longitudinal or lengthwise contour or shape (e.g., cylindrical, hourglass-shaped, etc.) of the adjustable portion 104c relative to a longitudinal axis of the body 104, e.g., between the longitudinal axis and individual ones of the longitudinal elements 108. Additionally, it is expected that covering the longitudinal elements 108 with a membrane can increase an axial stiffness of the membrane while allowing the membrane to rotate with the longitudinal elements 108, as described in greater detail below. In some embodiments, the adjustable portion 104c does not include the longitudinal elements 108, and instead simply includes a flexible membrane that defines the adjustable portion 104c.
  • a longitudinal or lengthwise contour or shape e.g., cylindrical, hourglass-shaped, etc.
  • the adjustable portion 104c can include a plurality of longitudinal elements 108 positioned adjacent and/or in close proximity to each other, a single (e.g., elongate, tubular, etc.) membrane, or have any other suitable configuration.
  • the assembly 100 can be transitioned between one or more configurations.
  • the assembly 100 can be transitionable between: (i) a first configuration 102a (FIG. 1A) in which the adjustable portion 104c has a first inner dimension (e.g., a first width Wl, a first inner diameter, etc.); (ii) a second configuration 102b (FIG. IB) in which the adjustable portion 104c has a second inner dimension (e.g., a second width W2, a second inner diameter, etc.) less than the first width Wl; (iii) a third configuration 102c (FIG.
  • the adjustable portion 104c has a third inner dimension (e.g., a third width W3, a third inner diameter, etc.) less than the second width W2; and (iv) a fourth configuration 102d (FIG. ID) in which the adjustable portion 104c has a fourth inner dimension (e.g., a fourth width W4, a fourth inner diameter, etc.) less than the third width W3.
  • one or more of the widths W1-W4 can be a minimum inner width of the adjustable portion 104c.
  • the inner dimensions (e.g., inner widths W1-W4) of the adjustable portion 104c can correspond to (e.g., be inversely proportional to, at least partially confer, etc.) a fluid resistance of the assembly 100.
  • the assembly 100 can provide: (i) a first resistance when in the first configuration 102a, (ii) a second resistance greater than the first resistance when in the second configuration 102b, (iii) a third resistance greater than the second resistance when in the third configuration 102c, and (iv) a fourth resistance greater than the third resistance when in the fourth configuration 102d.
  • the various resistances provided by the various configurations can correspond to a flow rate at which the fluid 101 can flow through the assembly 100 (e.g., to drain from a first body region to a second, different body region, such as to drain aqueous from an anterior chamber of a patient’s eye).
  • the assembly 100 can provide: (i) a first flow rate when in the first configuration 102a, (ii) a second flow rate less than the first flow rate when in the second configuration 102b, (iii) a third flow rate less than the second flow rate when in the third configuration 102c, and (iv) a fourth flow rate less than the third flow rate when in the fourth configuration 102d.
  • the relative level of therapy provided by each of the configurations 102a-d can be different so that a user may adjust the level of therapy provided by the assembly 100 by selectively increasing and/or decreasing the inner width of the adjustable portion 104c.
  • the assembly 100 can include more or fewer configurations, such as at least 1, 2, 3, 5, 6, or any other suitable number of configurations.
  • the assembly 100 can be transitioned between one or more of the configurations 102a-d by manipulating one or more portions of the assembly 100.
  • the assembly 100 can be transitioned between the configurations 102a-d by rotating the first end portion 104a of the body 104 in a direction R relative to the second end portion 104b of the body 104 (e.g., the second end portion 104b does not rotate in the direction R, or at least does not substantially rotate in the direction R).
  • the first end portion 104a of the body 104 in a direction R relative to the second end portion 104b of the body 104 (e.g., the second end portion 104b does not rotate in the direction R, or at least does not substantially rotate in the direction R).
  • rotating the first end portion 104a relative to the second end portion 104b in the direction R can cause one or more of the longitudinal elements 108 (and/or any membrane coupled thereto) to rotate and/or become angled relative to a longitudinal axis of the body 104, e.g., constricting the longitudinal elements 108 and/or reducing an inner dimension at a center or center region of the adjustable portion 104c. Transitioning the assembly 100 between one or more of the configurations 102a-d can cause a corresponding change in a contour or shape of the adjustable portion 104c.
  • transitioning the assembly 100 from the first configuration 102a to the third configuration 102c can change the shape of the adjustable portion 104c from a generally cylindrical shape to a generally hourglass-shaped shape, such that the adjustable portion 104c can constrict or taper inwardly toward the longitudinal axis of the body at or near the center or central region of the adjustable portion 104c.
  • the assembly 100 can be configured to operate in reverse, for example, by rotating the second end portion 104b of the body 104 relative to the first end portion 104a of the body 104.
  • the assembly 100 can be transitioned between the configurations 102a-d by rotating the first end portion 104a in a first direction and rotating the second end portion 104b in a second direction opposite the first direction.
  • the first end portion 104a can be rotated in the direction R, e.g., to transition the assembly 100 from the second configuration 102b shown in FIG. IB to the third configuration 102c shown in FIG. 1C.
  • the rotation of the first end portion 104a of the body 104 can cause a corresponding rotation of the first end 106a of the adjustable portion 104c.
  • transitioning the assembly 100 from the second configuration 102b to the third configuration 102c can reduce the inner width of the adjustable portion 104c from the second width W2 to the third width W3 which increases the fluid resistance of the assembly 100 and, under a given pressure, can reduce the flow rate of the fluid 101 through the assembly 100.
  • the first end portion 104a can be rotated in a direction opposite the direction R, e.g., to transition the assembly 100 from the third configuration 102c shown in FIG. 1C back to and/or toward the second configuration 102b shown in FIG. IB.
  • the rotation of the first end portion 104a of the body 104 can cause a corresponding rotation of the first end 106a of the adjustable portion 104c, such that the adjustable portion 104c can move outwardly, e.g., away from a longitudinal axis of the assembly 100 and increase the inner width of the adjustable portion 104c. Accordingly, as illustrated in FIGS.
  • transitioning the assembly 100 from the third configuration 102c to the second configuration 102b can increase the inner width of the adjustable portion 104c from the third width W3 to the second width W2 which decreases the fluid resistance of the assembly 100 and, under a given pressure, can increase the flow rate of the fluid 101 through the assembly 100.
  • the assembly 100 can be transitioned between any of the first and fourth configurations.
  • FIGS. 2 A and 2B illustrate perspective views of a flow control assembly 200 (“the assembly 200”) configured in accordance with various embodiments of the present technology. Specifically, FIG. 2A illustrates a perspective view of the assembly 200, and FIG. 2B illustrates an enlarged perspective view of a portion of the assembly 200 of FIG. 2A, with other aspects of the assembly 200 omitted for the purpose of clarity.
  • the assembly 200 can include certain features generally similar to or the same as corresponding features of the assembly 100 of FIGS. 1A-1D, with like numbers (e.g., adjustable portion 204c versus the adjustable portion 104c of FIGS. 1A-1D) indicating like or at least similar components.
  • the adjustable portion 204c of the assembly 200 is shown in FIG. 2A as having a membrane 209 extending between the first end portion 204a and the second end portion 204b of the body 204.
  • the membrane 209 can cover, extend around, at least partially contain, or otherwise include one or more longitudinal elements or spines (e.g., longitudinal elements 108 from FIGS. 1A-1D), as previously described with reference to FIGS. 1A-1D.
  • the assembly 200 further includes a housing 220 (which can also be referred to as a casing, a support structure, or the like). At least a portion of the body 204 can be positioned (e.g. housed) within and/or coupled to the housing 220. In some embodiments, the second end portion 204b of the body 204 can be fixed (e.g., rotationally fixed) relative to the housing 220, while the first end portion 204a of the body 204 can be configured to rotate relative to the housing 220. In FIG. 2A, the housing 220 is illustrated as semi-transparent (e.g., translucent) to better illustrate aspects of the assembly 200. In other embodiments, the housing 220 can be fully transparent or opaque.
  • the housing 220 can be formed from a rigid material, e.g., such that the housing 220 can have a greater stiffness than the adjustable portion 204c. Accordingly, the assembly 200 can be configured such that the adjustable portion 204c can transition between the configurations 102a-d described with reference to FIGS. 1A-1D without or substantially without rotation, twisting, and/or other deformations to the housing 220.
  • the housing 220 has a circular cross- sectional shape
  • the housing 220 can have an oval, triangular, square, rectangular, pentagonal, hexagonal, rectilinear, curvilinear, and/or any other suitable cross- sectional shape.
  • the housing 220 can have a same cross-sectional shape as at least a portion (e.g., the first end portion 204a, the second end portion 204b, the adjustable portion 204c, and/or any other suitable portion) of the body 204.
  • first end portion 204a and the second end portion 204b of the body 204 have a square cross-sectional shape and the adjustable portion 204c has a circular cross- sectional shape
  • first end portion 204a, the second end portion 204b, and the adjustable portion 204c of the body 204 can have a same cross-sectional shape, or one or more of the first end portion 204a, the second end portion 204b, and/or the adjustable portion 204c can have any other suitable cross-sectional shape.
  • the assembly 200 can further include a first fluid port or aperture (e.g., fluid inlet 222a) and a second fluid port or aperture (e.g., fluid outlet 222b) fluidly coupled to the lumen 205 defined by the body 204.
  • the fluid inlet 222a includes a tube or conduit fluidly coupled to the second end portion 204b of the body 204 and/or the housing 220
  • the fluid outlet 222b includes an opening in the first end portion 204a of the assembly 200.
  • the fluid inlet 222a can be an opening in the second end portion 204b of the assembly 200
  • the fluid outlet 222b can include a tube or conduit fluidly coupled to the first end portion 204a of the body 204 and/or the housing 220
  • the fluid inlet 222a and the fluid outlet 222b can each have any other suitable configuration.
  • the assembly 200 can further include an actuating or flow-control cap 224 (“the cap 224”).
  • the cap 224 is configured to receive (e.g., encircle, encompass, surround, contain, etc.) or otherwise couple to at least part of the first end portion 204a of the body 204.
  • the cap 224 can be configured to receive at least part of the second end portion 204b of the body 204.
  • the cap 224 can be a first cap configured to receive at least a first part of the first end portion 204a of the body 204, and the assembly 200 can further include a second cap generally similar to or the same as the first cap and configured to receive at least a second part of the second end portion 204b of the body 204.
  • the cap 224 can be moveably (e.g., rotatably) coupled to the housing 220 and operably engaged with at least part of the first end portion 204a of the body 204, such that rotating the cap 224 can cause a corresponding rotation of the first end portion 204a of the body 204 without causing a corresponding rotation of the housing 220.
  • the cap 224 has an inner perimeter 226 defining an opening or aperture sized and/or shaped to correspond to the size and/or shape of the first end portion 204a of the body 204.
  • the cap 224 and the first end portion 204a of the body 204 can form (e.g., be manufactured as) a single-piece component, the cap 224 can be coupled to the first end portion 204a of the body 204 via a friction fit, via one or more fasteners and/or adhesives, and/or via another mechanism that enables the rotation of the cap 224 to induce rotation of the first end portion 204a of the body.
  • fluid 201 can enter the assembly 200 (e.g., from a first body region) via the fluid inlet 222a, flow through the assembly 200 (e.g., through the body 204, similar to as described previously and with reference to FIGS. 1A-1D) in the direction shown in FIG. 2A, and exit the assembly 200 (e.g., into a second body region) via the fluid outlet 222b.
  • the assembly 200 can operate in reverse, e.g., such that the fluid 201 can enter the assembly 200 via the fluid outlet 222b, flow through the assembly in a direction opposite the direction shown in FIG. 2A, and exit the assembly via the fluid inlet 222a.
  • the cap 224 can be rotated relative to the housing 220 to change the configuration of the assembly 200, e.g., by rotating the first end portion 204a of the body 204 relative to the second end portion 204b of the body 204 to adjust an inner width W of the adjustable portion 204c and control the corresponding fluid resistance and, under a given pressure, the flow rate of the fluid 201 through the assembly 200, as described previously and with reference to FIGS. 1A-1D.
  • the second end portion 204b of the body 204 can be rotationally fixed to the housing 220 such that rotation of the first end portion 204a of the body 204 can cause the adjustable portion 204c to constrict or expand, e.g., decreasing or increasing the inner width W of the adjustable portion 204c as described previously and with reference to FIGS. 1A-1D.
  • the cap 224 can include a first interface surface 228 (“the first surface 228”)
  • the housing 220 can include a second interface surface 229 (“the second surface 229”)
  • the first surface 228 can be moveably and/or operably coupled to the second surface 229.
  • the first and second surfaces 228, 229 can be configured to allow the cap 224 to be rotated in one or more increments, e.g., between the one or more configurations described previously above with reference to FIGS. 1 A-1D.
  • the first surface 228 includes one or more protrusions 228a (e.g., teeth, lobes, ridges, interface features etc.) and the second surface 229 includes one or more corresponding recesses 229a (e.g., recessed areas, valleys, interface features, etc.), and each of the recesses 229a is configured to receive at least one of the protrusions 228a.
  • the first surface 228 can include the recessed areas 229a and the second surface 229 can include corresponding protrusions 228a. Accordingly, the first surface 228 and the second surface 229 can both form a “sawtooth” configuration. In the illustrated embodiment, for example, the entire perimeter of the first surface 228 includes the protrusions 228a and only part of the perimeter of the second surface 229 includes the recesses 229a. In other embodiments, however, only part of the perimeter of the first surface 228 can include the productions 228a and the entire perimeter of the second surface 229 can include the recesses 229a.
  • first and second surfaces 228, 229 have, respectively, generally linear protrusions 228a and recesses 229a
  • the first surface 228 and/or the second surface 229 can have, respectively, generally curved or arcuate protrusions 228a and recesses 229a, and/or have protrusions 228a and recesses 229a with any other suitable configuration.
  • the first surface 228 and the second surface 229 can be generally similar or the same, such that the first surface 228 and the second surface 229 can have a generally similar or a same configuration but be rotationally (e.g., radially, axially, etc.) offset from each other.
  • the recesses 229a can be recessed areas between individual ones of the protrusions 228a and/or the protrusions 228a can be ridges separating individual ones of the recesses 229a.
  • individual ones of the protrusions 228a and/or the recesses 229a can have any other suitable configuration, dimensions, spacing (e.g., uniformly spaced, non-uniformly or variably spaced, etc.), and/or alignment relative to each other.
  • the cap 224 when the cap 224 is rotated (e.g., in a first direction R1 or a second direction R2), individual ones (e.g., one or more, a plurality, each, etc.) of the protrusions 228a can advance from a first recess to a second (e.g., neighboring, next, nearest, proximate, etc.) recess. Further rotation of the cap 224 can translate individual ones of the protrusions 228a through additional recesses 229a.
  • Advancing the protrusions 228a from the first recess to the second recess can represent a single rotational increment or unit, and each rotational increment can be associated with a configuration of the body 204, a corresponding inner width W of the adjustable portion 204c, and the associated fluid resistance and/or flow rate.
  • Each rotational increment can be based on the respective configuration of individual ones of the protrusions 228a and/or the recesses 229a.
  • all of the protrusions 228a and recesses 229a are the same or substantially the same such that each of the rotational increments represents a same or substantially the same increment of rotation of the cap 224 and a corresponding same or substantially the same increment of change to the assembly 200 (e.g., a same increment of change to the configuration, inner width W, fluid resistance, etc.).
  • At least one of the protrusions 228a and/or recesses 229a can be differently sized and/or non-uniformly spaced compared to the other protrusions 228a and/or recesses 229a, such that at least one of the rotational increments represents a greater or lesser increment of rotation of the cap 224 compared to other rotational increments and a correspondingly greater or lesser increment of change to the assembly 200 (e.g., a greater or lesser increment of change to the configuration, inner width W, fluid resistance, etc.) compared to other changes to the assembly 200.
  • assemblies configured in accordance with embodiments of the present technology are expected to allow for repeated and/or consistent transitioning between various configurations, e.g., to provide an adjustable therapy to a patient.
  • the interaction between the protrusions 228a and the recesses 229a can at least partially or fully prevent unwanted or unintended rotation of the cap 224 and/or the first end portion 204a, which, in turn, can at least partially or fully prevent unwanted or unintended changes to the inner width W of the adjustable portion 204c.
  • the protrusions 228a and/or the recesses 229a can be configured such that, after rotating a given number of increments, the protrusions 228a and/or the recesses 229a can interface to at least partially or fully prevent further rotation of the cap 224 and/or the first end portion 204a, e.g., to maintain the adjustable portion 204c at a given inner width W.
  • FIG. 3 illustrates a partially schematic top view of an actuation mechanism 330 configured in accordance with various embodiments of the present technology.
  • the actuation mechanism 330 can be at least a portion of a flow control assembly, such as the assembly 100 of FIGS. 1 A-1D, the assembly 200 of FIGS. 2A and 2B, or any other suitable flow control assembly, and can be used to selectively drive rotation of the assembly 100 and/or the assembly 200 through various configurations to adjust the fluid resistance provided by the respective flow control assembly 100, 200.
  • the actuation mechanism 330 can include a driven element 332, a drive element or pall 338, and one or more actuation elements 334a-b (shown as a first actuation element 334a and a second actuation element 334b in FIG. 3).
  • the actuation element(s) 334a-b and the pall 338 can be operably coupled to the driven element 332.
  • the driven element 332 can be coupled to the cap 224 (FIGS. 2 A and 2B) and/or the first end portion 104a, 204a of the body 104, 204 (FIGS.
  • actuation element(s) 334a-b and the pall 338 can be operable to rotate the driven element 332 and the cap 224, e.g., to transition the assembly 100, 200 (FIGS. 1 A-2B) between one or more of the configurations 102a-d (FIGS. 1 A- 1D).
  • the driven element 332 can include an axis 336 and one or more engagement features 342 positioned radially about an outer perimeter of the driven element 332.
  • Each of the engagement features 342 can include a first surface 344a (e.g., a drive surface) and a second surface 344b (e.g., a return surface) opposite the drive surface 344a.
  • the driven element 332 includes ten engagement features 342.
  • the driven element 332 can include more or fewer engagement features 342, such as less than ten engagement features, more than ten engagement features, and/or any other suitable number of engagement features 342.
  • the number of engagement features 342 can correspond to the number of configurations 102 of the assembly 100 or the assembly 200. Although in the illustrated embodiment each of the engagement features 342 is illustrated as having generally similar or the same dimensions, in other embodiments one or more of the engagement features can have at least one different dimension (e.g., individual ones of the engagement features 342 can have differing sizes, spacing, etc.). As described in greater detail below, each of the engagement features 342 can correspond to a rotational increment of a cap and/or a configuration of a flow control assembly, such as the rotational increments of the cap 224 and/or the configurations of the assembly 200 described previously and with reference to FIGS. 2 A and 2B.
  • Each of the actuation elements 334a-b can include a first end portion coupled to the pall 338.
  • a first end portion 334ai of the first actuation element 334a is coupled to a first side 340a of the pall 338
  • a first end portion 334bi of the second actuation element 334b is coupled to a second side 340b of the pall 338 opposite the first side 340a.
  • Each of the actuation elements 334a-b further include a respective second end portion 334a2, 334b2 opposite and spaced apart from the corresponding first end portions 334ai, 334bi.
  • each of the second end portions 334a2, 334b2 of the actuation elements 334a-b can have a fixed position, e.g., relative to the axis 336 of the driven element 332.
  • the second end portions 334a2, 334b2 can be coupled to an interior surface of the housing 220 (FIGS. 2A and 2B), or any other suitable portion of the assembly 200 (FIGS. 2A and 2B).
  • Each of the actuation elements 334a-b can be actuated to move the pall 338 to contact at least a portion of one of the engagement features 342 (e.g., at least a portion of the drive surface 344a or the return surface 344b) of the driven element 332.
  • actuating the actuation elements 334a-b can drive rotation (e.g., incremental rotation, gradual rotation, etc.) of the driven element 332.
  • Each of the actuation elements 334a-b can be composed at least partially of a shape memory material or alloy (e.g., nitinol). Accordingly, each actuation element 334a-b can be transitionable at least between a first material phase or state (e.g., a martensitic state, a R-phase, a composite state between martensitic and R-phase, etc.) and a second material phase or state (e.g., an austenitic state, an R-phase state, a composite state between austenitic and R-phase, etc.).
  • a first material phase or state e.g., a martensitic state, a R-phase, a composite state between martensitic and R-phase, etc.
  • a second material phase or state e.g., an austenitic state, an R-phase state, a composite state between austenitic and R-phase, etc.
  • the actuation elements 334a-b may have reduced (e.g., relatively less stiff) mechanical properties that cause the actuation elements to be more easily deformable (e.g., compressible, expandable, etc.) relative to when the actuation elements are in the first material state.
  • the actuation elements 334a-b may have increased (e.g., relatively stiffer) mechanical properties relative to the first material state, causing an increased preference toward a specific preferred geometry (e.g., original geometry, manufactured or fabricated geometry, heat set geometry, etc.).
  • the first actuation element 334a and the second actuation element 334b can be selectively and independently transitioned between the first material state and the second material state by applying energy (e.g., laser energy, electrical energy, etc.) to the first actuation element 334a or the second actuation element 334b to heat it above a transition temperature (e.g., above an austenite finish (Af) temperature, which is generally greater than body temperature). If the first actuation element 334a (or the second actuation element 334b) is deformed relative to its preferred geometry when heated above the transition temperature, the first actuation element 334a (or the second actuation element 334b) will move to and/or toward its preferred geometry.
  • energy e.g., laser energy, electrical energy, etc.
  • first actuation element 334a and the second actuation element 334b are operably coupled such that, when the actuated actuation element (e.g., the first actuation element 334a) transitions toward its preferred geometry, the non-actuated actuation element (e.g., the second actuation element 334b) is further deformed relative to its preferred geometry.
  • the first actuation element 334a and the second actuation element 334b generally act in opposition.
  • first actuation element 334a can be actuated to move the pall 338 in a first direction DI
  • second actuation element 334b can be actuated to move the pall 338 in a second direction D2 generally or substantially opposite the first direction DI.
  • first actuation element 334a and the second actuation element 334b can be coupled such that, as one moves toward its preferred geometry upon material phase transition, the other is deformed relative to its preferred geometry. This enables the actuation elements 334a-b to be repeatedly actuated and the pall 338 to be repeatedly cycled in the first direction DI and the second direction D2.
  • PCT/US21/27742 the disclosures of which are incorporated by reference herein in their entireties and for all purposes.
  • each of the actuation elements 334a-b can be actuated to drive movement of the pall 338 relative to the axis 336 of the driven element 332, e.g., to drive rotation of the driven element 332 in a direction indicated by arrow A.
  • the actuation mechanism 330 can be configured such that, when the first actuation element 334a is heated above its transition temperature, the first end portion 334ai of the first actuation element 334a moves in the first direction DI as the first actuation element 334a moves to and/or toward its preferred geometry. The movement of the first actuation element 334a to and/or toward its preferred geometry can drive the pall 338 in the first direction DI.
  • the pall 338 As the pall 338 moves in the first direction DI, the pall 338 (e.g., the second side 340b of the pall 338) can contact a drive surface 344ai of a first engagement feature 342a.
  • the drive surface 344ai can be configured such that the movement of the pall 338 in the first direction DI can drive rotation of the first engagement feature 342a in the rotation direction A which, in turn, can cause the driven element 332 to rotate about the axis 336 in the rotation direction A.
  • the driven element 332 can be coupled to the cap 224 of the assembly 200 of FIGS.
  • the rotation of the driven element 332 can adjust (e.g., decrease or increase) the inner width W of the adjustable portion 204c of the body 204.
  • the interaction between the first surface 228 and the second surface 229 can at least partially or fully prevent the driven element 332 from unwanted or unintended rotation, e.g., from rotating in the rotation direction A or in a direction opposite the rotation direction A.
  • the force induced on the cap 224 by the driven element 332 in response to actuation of the first actuation element 334a can be sufficient to overcome the static friction force between the first surface 228 and the second surface 229. Accordingly, the driven element 332 (and thus the cap 224) can rotate in response to actuation of one or more of the actuation elements 334a-b.
  • the actuation mechanism 330 can be further configured such that, when the second actuation element 334b is heated above its transition temperature, the first end portion 334bi of the second actuation element 334b moves in the second direction D2 (e.g., opposite the first direction DI) as the second actuation element 334b moves to and/or towards its preferred geometry.
  • the movement of first end portion 334bi in the second direction D2 can drive the pall 338 in the second direction D2.
  • the pall 338 can translate across a return surface 344b2 of a second engagement feature 342b to and/or toward a drive surface 344a2 of the second engagement feature 342b.
  • the second actuation element 334b can be sized and/or positioned such that the pall 338 contacts the drive surface 344a2 and/or a return surface 344bs of a third engagement feature 342c when the second actuation element 334b is at or near its preferred geometry.
  • the first and second actuation elements 334a-b can act in opposition.
  • the movement of the pall 338 in the second direction D2 can reset the actuation mechanism 330 (e.g., deforming the first actuation element 334a relative to its preferred geometry), such that the actuation mechanism 330 can be repeatedly actuated, with each successive actuation cycle being generally similar to or the same as the actuation cycle described above, e.g., to drive further rotation of the driven element 332.
  • the interaction between the first surface 228 and the second surface 229 can prevent unwanted and/or unintended rotation of the driven element 332 while the pall 338 translates across the second return surface 344b2 in the second direction D2, as described previously.
  • the actuation mechanism 330 can be configured to operate in reverse, such that the second actuation element 334b can be heated above its transition temperature to move the pall 338 in the first direction DI and rotate the driven element 332, and the first actuation element 334a can be heated above its transition temperature to move the pall 338 in the second direction D2 and reset the actuation mechanism 330.
  • a plurality of actuation mechanisms 330 can be used as part of a flow control assembly. For example, referring to FIGS.
  • the assembly 200 can include a first actuation mechanism operable to rotate the first end portion 204a of the body 204 in a direction to decrease the inner width W of the adjustable portion 204c, and a second actuation mechanism operable to rotate the second end portion 204b of the body in the same direction to increase the inner width W of the adjustable portion 204c.
  • FIG. 4 is a perspective view of another flow control assembly 400 (“the assembly 400”) configured in accordance with various embodiments of the present technology.
  • the assembly 400 can be generally similar to or the same as the assembly 100 of FIGS. 1 A-1D and/or the assembly 200 of FIGS. 2A and 2B, with like numbers (e.g., the body 404 versus the body 104 of FIGS. 1A-1D, the body 204 of FIGS. 2A-2B).
  • the assembly 400 can include a cap 424 that is supported by a central axis or shaft 425.
  • the shaft 425 can extend at least partially or fully through a body 404 and/or a first (e.g., inner) housing 420 of the assembly 400, and can be rotatably coupled to the body 404 (e.g., a first end portion of the body 404; not shown) and/or the first housing 420.
  • the cap 424 can include a first surface 428 configured to allow for incremental rotation of the cap 424 about the shaft 425.
  • the cap 424 can also include an opening 422 that can serve as a fluid inlet or a fluid outlet of the assembly 400.
  • the opening 422 includes four fan-shaped apertures in the cap 424, each extending radially from the shaft 425, in other embodiments the opening can include more or fewer fan-shaped apertures, and/or apertures of any other suitable shape and/or position relative to the shaft 425.
  • the assembly 400 can include a second (e.g., outer) housing 421.
  • the second housing 421 can be configured to contain at least a portion of the first housing 420 and/or at least a portion the body 404.
  • a first end portion (not shown) of the body 404 is positioned within the second housing 421.
  • the second housing 421 e.g., an interior region of the second housing 421), and/or a portion of the first housing 420 positioned within the second housing 421, can include a second surface (not shown) which can be generally similar to or the same as the second surface 229 of FIG.
  • the cap 424 can be at least partially or fully received by the second housing 421, such that generally or substantially all fluid flowing through the assembly 400 passes through the opening 422 in the cap 424.
  • one or more of the flow control assemblies and/or actuation mechanisms described above can be used as part of an adjustable shunting system, e.g., to control the flow of fluid therethrough.
  • flow control assemblies and actuation mechanisms can be added or combined with another flow control assembly or actuation mechanism. Accordingly, the present technology is not limited to the flow control assemblies and actuation mechanisms expressly identified herein.
  • the flow control assemblies and actuation mechanisms described herein could be utilized with the adjustable shunting systems and actuation assemblies described in U.S. Patent Application No. 17/175,332, U.S. Patent App. Publication No. 2020/0229982, and International Patent Application Nos. PCT/US20/55144, PCT7US20/55141, PCT/US21/14774, PCT/US21/18601, PCT/US21/023238, and
  • a flow control assembly for use with a shunting system for shunting fluid between a first body region and a second body region, the flow control assembly comprising: a hollow body having a first end portion, a second end portion opposite the first end portion, and an adjustable portion extending between the first end portion and the second end portion, wherein the adjustable portion has an inner dimension that corresponds to a fluid resistance of the flow control assembly; and an actuation mechanism operably coupled to the body, wherein the actuation mechanism is configured to rotate the first end portion of the body relative to the second end portion of the body to change the inner dimension of the adjustable portion of the body.
  • the first surface includes a first plurality of teeth
  • the second surface includes a second plurality of teeth
  • the second plurality of teeth are configured to releasably couple the first plurality of teeth.
  • An adjustable shunting system for draining fluid from a first body region to a second body region, the adjustable shunting system comprising: a housing; and a body positioned at least partially within the housing, the body defining an adjustable lumen having an adjustable minimum dimension; wherein a first portion of the body is configured to rotate relative to the housing and a second portion of the body is configured to remain stationary relative to the housing, such that the body is configured to transition between — a first configuration where the adjustable lumen has a first minimum dimension, and a second configuration where the adjustable lumen has a second minimum dimension.
  • the adjustable shunting system of any of examples 19-21 wherein: the first portion of the body is opposite and spaced apart from the second portion of the body; the second portion includes a fluid inlet; the first portion includes a fluid outlet; and the adjustable lumen is configured to receive fluid via the fluid inlet and drain fluid from the adjustable shunting system via the fluid outlet.
  • a method for selectively controlling fluid flow from a first body region to a second body region through a shunting system having a flow control assembly comprising: applying energy to an actuation element of an actuation mechanism of the flow control assembly; and in response to the applied energy, rotating a driven element of the actuation mechanism, wherein rotating the driven element includes rotating a first end of the adjustable portion relative to a second end of the adjustable portion to change an inner dimension of an adjustable portion of the flow control assembly.
  • rotating the driven element includes transitioning the adjustable portion between a first configuration in which the adjustable portion has a first inner dimension and a second configuration in which the adjustable portion has a second inner dimension less than the first inner dimension.
  • rotating the first end of the adjustable portion relative to the second end of the adjustable portion includes rotating at least a portion of one or more longitudinal elements of the flow control assembly relative to a longitudinal axis of the adjustable portion, the one or more longitudinal elements extending at least partially between the first end and the second end.
  • An adjustable shunting system for draining fluid in a patient comprising: a hollow body including a flexible membrane and a plurality of longitudinal elements, the flexible membrane and the plurality of longitudinal elements defining an adjustable lumen, wherein a first portion of the body is configured to rotate relative to a second portion of the body such that the body is transitionable between a first generally cylindrical shape and a second generally hourglass shape, wherein, in the first generally cylindrical shape, the adjustable lumen has a first minimum dimension, and wherein, in the second generally hourglass shape, the adjustable lumen as a second minimum dimensions less than the first minimum dimension.
  • the adjustable shunting system of example 39 wherein: in the first generally cylindrical shape, the first minimum dimension is at a center region of the adjustable lumen, and in the second generally hourglass shape, the second minimum dimension is at the center region of the adjustable lumen.
  • the words “comprise,” “comprising,” and the like are to be construed in an inclusive sense, as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to.”
  • the terms “connected,” “coupled,” or any variant thereof means any connection or coupling, either direct or indirect, between two or more elements; the coupling of connection between the elements can be physical, logical, or a combination thereof.
  • the words “herein,” “above,” “below,” and words of similar import when used in this application, shall refer to this application as a whole and not to any particular portions of this application.

Abstract

The present technology is generally directed to adjustable shunting systems, including adjustable shunting systems with flow control assemblies having adjustable lumens. The flow control assembly can include a body that defines a lumen. The body can include an adjustable portion having an inner width or diameter that is inversely proportional to a fluid resistance of the lumen. The flow control assembly can be configured to transition between one or more configurations, and each configuration can correspond to a different inner width of the adjustable portion. The flow control assembly can be rotation-based, such that transitioning the flow control assembly between the one or more configurations can include rotating at least part of the flow control assembly.

Description

FLOW CONTROL ASSEMBLIES WITH ADJUSTABLE LUMENS FOR ADJUSTABLE SHUNTING SYSTEMS, AND ASSOCIATED SYSTEMS, METHODS AND DEVICES
TECHNICAL FIELD
[0001] The present technology generally relates to implantable medical devices and, in particular, to adjustable shunting systems and associated methods for selectively controlling fluid flow between a first body region and a second body region of a patient.
BACKGROUND
[0002] 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. The flow of fluid through the shunting systems is primarily controlled by the pressure gradient across the shunt and the physical characteristics of the flow path defined through the shunt (e.g., the resistance of the shunt lumen(s)). However, most shunting systems have a single static flow path that is not adjustable. Accordingly, one challenge with conventional shunting systems is selecting the appropriate size shunt for a particular patient. A shunt that is too small may not provide enough therapy to the patient, while a shunt that is too large may create new issues in the patient. Despite this, most conventional shunts cannot be adjusted after implantation and, therefore, cannot be adjusted or titrated to meet the patient’s individual and variable needs and/or to account for changes in flow-related characteristics, such as flow volume, inflow pressure, and/or outflow resistance.
BRIEF DESCRIPTION OF THE DRAWINGS
[0003] 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.
[0004] FIGS. 1A-1D are schematic illustrations of a flow control assembly configured in accordance with various embodiments of the present technology. [0005] FIG. 2A is a perspective view of a flow control assembly configured in accordance with various embodiments of the present technology.
[0006] FIG. 2B is an enlarged perspective view of a portion of the flow control assembly of FIG. 2A.
[0007] FIG. 3 is a partially schematic top side of an actuation mechanism for adjusting a flow control assembly and configured in accordance with various embodiments of the present technology.
[0008] FIG. 4 is a perspective view of another flow control assembly configured in accordance with various embodiments of the present technology.
DETAILED DESCRIPTION
[0009] The present technology is generally directed to adjustable shunting systems, including adjustable shunting systems with flow control assemblies having adjustable lumens. The flow control assembly can include a body that defines a lumen. The body can include an adjustable portion having an inner dimension (e.g., width, diameter, etc.) that is proportional to a fluid resistance of the lumen. The flow control assembly can be configured to transition between one or more configurations, and each configuration can correspond to a different inner dimension of the adjustable portion. The flow control assembly can be rotation-based, such that transitioning the flow control assembly between the one or more configurations can include rotating at least part of the flow control assembly. For example, in response to rotation, the flow control assembly can be configured to twist or constrict the adjustable portion inwardly (e.g., toward a longitudinal axis of the body) to reduce the inner dimension of the adjustable portion. Reducing the inner dimension of the adjustable portion can increase the fluid resistance of the flow control assembly.
[0010] As described in greater detail below, it is expected that in at least some embodiments the present technology may exhibit one or more advantageous characteristics that improve shunting systems. For example, shunting systems having flow control assemblies configured in accordance with embodiments of the present technology can include a single lumen defining a single flow path that is adjustable to provide a range of fluid resistances. Accordingly, adjustable shunting systems including flow control assemblies in accordance with embodiments of the present technology are expected to provide a titratable therapy while still being relatively small and relatively easy to implement. Additionally, flow control assemblies configured in accordance with embodiments of the present technology are expected to exhibit a greater degree of adjustability compared to many shunting systems. For example, the rotation-based transitioning of the flow control assemblies described herein can result in incremental or gradual changes to the inner dimension of the adjustable portion. Such incremental changes can allow the flow control assembly to be adjusted between a greater number of different fluid resistances compared to many shunting systems, particularly in embodiments in which flow the flow rate through the system is relatively high. Of course, the present technology may also provide additional advantageous characteristics not expressly described herein.
[0011] The terminology used in the description presented herein 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. 1A-4.
[0012] 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 described herein may be combined in any suitable manner in one or more embodiments.
[0013] Reference throughout this specification to relative terms such as, for example, “generally,” “approximately,” and “about” are used herein to mean the stated value plus or minus 10%. Reference throughout this specification to the term “resistance” refers to fluid resistance unless the context clearly dictates otherwise. The terms “drainage rate” and “flow rate” are used interchangeably to describe the movement of fluid through a structure at a particular volumetric rate. The term “flow” is used herein to refer to the motion of fluid, in general.
[0014] Although certain embodiments herein are described in terms of shunting fluid from an anterior chamber of an eye, one of skill in the art will appreciate that the present technology can be readily adapted to shunt fluid from and/or between other portions of the eye, or, more generally, from and/or between a first body region and a second body region. Moreover, while the certain embodiments herein are described in the context of glaucoma treatment, any of the embodiments herein, including those referred to as “glaucoma shunts” or “glaucoma devices” may nevertheless be used and/or modified to treat other diseases or conditions, including other diseases or conditions of the eye or other body regions. For example, the systems described herein can be used to treat diseases characterized by increased pressure and/or fluid build-up, including but not limited to heart failure (e.g., heart failure with preserved ejection fraction, heart failure with reduced ejection fraction, etc.), pulmonary failure, renal failure, hydrocephalus, and the like. Moreover, while generally described in terms of shunting aqueous, the systems described herein may be applied equally to shunting other fluid, such as blood or cerebrospinal fluid, between the first body region and the second body region.
[0015] FIGS. 1A-1D schematically illustrate a flow control assembly 100 (“the assembly 100”) configured in accordance with various embodiments of the present technology. As described in greater detail below, the assembly 100 can be incorporated into an adjustable shunting system and used to selectively adjust or titrate the fluid resistance through the shunting system. The assembly 100 can be incorporated into any suitable shunting system having a lumen, such as any of the adjustable shunting systems incorporated by reference herein, and/or any other suitable adjustable shunting system. For example, the assembly 100 can be positioned at least partially around (e.g., external to, aligned with, about, containing etc.) a fluid channel or conduit of a shunting system. As a further example, and as described in greater detail below, the assembly 100 can include a flexible and impermeable membrane.
[0016] The assembly 100 can include a generally elongate body 104 (which can also be referred to as a shunting element, a conduit, or the like) having a first end portion 104a, a second end portion 104b opposite the first end portion 104a, and an adjustable portion 104c extending between the first end portion 104a and the second end portion 104b. The adjustable portion 104c can define an inner contour or shape of the body 104 having one or more dimensions(e.g., width, diameter, etc.) of the body 104. The adjustable portion 104c can have a first end 106a proximate and/or coupled to the first end portion 104a of the body 104 and a second end 106b proximate and/or coupled to the second end portion 104b of the body 104. Accordingly, the first end 106a of the adjustable portion 104c can move (e.g., rotate) in concert with the first end portion 104a of the body 104 and/or the second end 106b of the adjustable portion 104c can move (e.g., rotate) in concert with the second end portion 104b of the body 104.
[0017] The body 104 can be partially or fully hollow, such that the body 104 can define a lumen 105 through which fluid 101 (e.g., aqueous) can flow. In the illustrated embodiment, for example, the fluid 101 can enter the body 104 via the second end portion 104b, flow through the adjustable portion 104c, and exit the body 104 via the first end portion 104a. In other embodiments, fluid can flow through the body 104 in reverse, e.g., entering the body 104 via the first end portion 104a and exiting the body 104 via the second end portion 104b.
[0018] Although in the illustrated embodiment the body 104 has a circular cross-sectional shape, in other embodiments the body 104 can have an oval, triangular, square, rectangular, pentagonal, hexagonal, rectilinear, curvilinear, and/or any other suitable cross-sectional shape. Although in the illustrated embodiment the first end portion 104a, the second end portion 104b, and the adjustable portion 104c of the body 104 have a same cross-sectional shape, in other embodiments one or more of the first end portion 104a, the second end portion 104b, and/or the adjustable portion 104c of the body 104 can have a different cross-sectional shape.
[0019] The adjustable portion 104c in FIGS. 1A-1D can include a plurality of longitudinal elements 108 (e.g., spines, filaments, fibers, etc.) that are spaced apart from each other. The longitudinal elements 108 can be covered by a flexible and impermeable membrane (not shown) or the like such that the fluid 101 that flows through the adjustable portion 104c is generally or substantially prevented from leaking from the assembly 100 (e.g., at least at locations along the adjustable portion 104c). The longitudinal elements 108 can at least partially define a contour, profile, and/or minimum dimension of a portion (e.g., the adjustable portion 104c) of the body 104. In at least some embodiments, for example, the longitudinal elements 108 can define a longitudinal or lengthwise contour or shape (e.g., cylindrical, hourglass-shaped, etc.) of the adjustable portion 104c relative to a longitudinal axis of the body 104, e.g., between the longitudinal axis and individual ones of the longitudinal elements 108. Additionally, it is expected that covering the longitudinal elements 108 with a membrane can increase an axial stiffness of the membrane while allowing the membrane to rotate with the longitudinal elements 108, as described in greater detail below. In some embodiments, the adjustable portion 104c does not include the longitudinal elements 108, and instead simply includes a flexible membrane that defines the adjustable portion 104c. Accordingly, in various embodiments, the adjustable portion 104c can include a plurality of longitudinal elements 108 positioned adjacent and/or in close proximity to each other, a single (e.g., elongate, tubular, etc.) membrane, or have any other suitable configuration.
[0020] In operation, the assembly 100 can be transitioned between one or more configurations. In the illustrated embodiment, for example, the assembly 100 can be transitionable between: (i) a first configuration 102a (FIG. 1A) in which the adjustable portion 104c has a first inner dimension (e.g., a first width Wl, a first inner diameter, etc.); (ii) a second configuration 102b (FIG. IB) in which the adjustable portion 104c has a second inner dimension (e.g., a second width W2, a second inner diameter, etc.) less than the first width Wl; (iii) a third configuration 102c (FIG. 1C) in which the adjustable portion 104c has a third inner dimension (e.g., a third width W3, a third inner diameter, etc.) less than the second width W2; and (iv) a fourth configuration 102d (FIG. ID) in which the adjustable portion 104c has a fourth inner dimension (e.g., a fourth width W4, a fourth inner diameter, etc.) less than the third width W3. In at least some embodiments, one or more of the widths W1-W4 can be a minimum inner width of the adjustable portion 104c. The inner dimensions (e.g., inner widths W1-W4) of the adjustable portion 104c (e.g., the dimensions of the inner contour defined by the adjustable portion 104c) can correspond to (e.g., be inversely proportional to, at least partially confer, etc.) a fluid resistance of the assembly 100. For example, the assembly 100 can provide: (i) a first resistance when in the first configuration 102a, (ii) a second resistance greater than the first resistance when in the second configuration 102b, (iii) a third resistance greater than the second resistance when in the third configuration 102c, and (iv) a fourth resistance greater than the third resistance when in the fourth configuration 102d. Thus, for a given fluid pressure the various resistances provided by the various configurations can correspond to a flow rate at which the fluid 101 can flow through the assembly 100 (e.g., to drain from a first body region to a second, different body region, such as to drain aqueous from an anterior chamber of a patient’s eye). For example, under a given pressure, the assembly 100 can provide: (i) a first flow rate when in the first configuration 102a, (ii) a second flow rate less than the first flow rate when in the second configuration 102b, (iii) a third flow rate less than the second flow rate when in the third configuration 102c, and (iv) a fourth flow rate less than the third flow rate when in the fourth configuration 102d. Accordingly, the relative level of therapy provided by each of the configurations 102a-d can be different so that a user may adjust the level of therapy provided by the assembly 100 by selectively increasing and/or decreasing the inner width of the adjustable portion 104c. Although illustrated as having four configurations 102a-d in FIGS. 1A-1D, in other embodiments the assembly 100 can include more or fewer configurations, such as at least 1, 2, 3, 5, 6, or any other suitable number of configurations.
[0021] The assembly 100 can be transitioned between one or more of the configurations 102a-d by manipulating one or more portions of the assembly 100. In the illustrated embodiment, the assembly 100 can be transitioned between the configurations 102a-d by rotating the first end portion 104a of the body 104 in a direction R relative to the second end portion 104b of the body 104 (e.g., the second end portion 104b does not rotate in the direction R, or at least does not substantially rotate in the direction R). As illustrated in FIGS. 1 A-1D, rotating the first end portion 104a relative to the second end portion 104b in the direction R can cause one or more of the longitudinal elements 108 (and/or any membrane coupled thereto) to rotate and/or become angled relative to a longitudinal axis of the body 104, e.g., constricting the longitudinal elements 108 and/or reducing an inner dimension at a center or center region of the adjustable portion 104c. Transitioning the assembly 100 between one or more of the configurations 102a-d can cause a corresponding change in a contour or shape of the adjustable portion 104c. For example, transitioning the assembly 100 from the first configuration 102a to the third configuration 102c can change the shape of the adjustable portion 104c from a generally cylindrical shape to a generally hourglass-shaped shape, such that the adjustable portion 104c can constrict or taper inwardly toward the longitudinal axis of the body at or near the center or central region of the adjustable portion 104c. In other embodiments, the assembly 100 can be configured to operate in reverse, for example, by rotating the second end portion 104b of the body 104 relative to the first end portion 104a of the body 104. In these and other embodiments, the assembly 100 can be transitioned between the configurations 102a-d by rotating the first end portion 104a in a first direction and rotating the second end portion 104b in a second direction opposite the first direction.
[0022] As a specific example, to decrease the flow rate of the fluid 101 through the assembly 100, the first end portion 104a can be rotated in the direction R, e.g., to transition the assembly 100 from the second configuration 102b shown in FIG. IB to the third configuration 102c shown in FIG. 1C. The rotation of the first end portion 104a of the body 104 can cause a corresponding rotation of the first end 106a of the adjustable portion 104c. Because the second end 106b of the adjustable portion 104c is coupled to the second end portion 104b of the body 104, rotating the first end 106a of the adjustable portion 104c can cause the adjustable portion 104c to compress (e.g., contract, twist, constrict, etc.), e.g., reducing the inner width of the adjustable portion 104c. Accordingly, as illustrated in FIGS. IB and 1C, transitioning the assembly 100 from the second configuration 102b to the third configuration 102c can reduce the inner width of the adjustable portion 104c from the second width W2 to the third width W3 which increases the fluid resistance of the assembly 100 and, under a given pressure, can reduce the flow rate of the fluid 101 through the assembly 100.
[0023] As a further example, to increase the flow rate of the fluid 101 through the assembly 100, the first end portion 104a can be rotated in a direction opposite the direction R, e.g., to transition the assembly 100 from the third configuration 102c shown in FIG. 1C back to and/or toward the second configuration 102b shown in FIG. IB. As described previously, the rotation of the first end portion 104a of the body 104 can cause a corresponding rotation of the first end 106a of the adjustable portion 104c, such that the adjustable portion 104c can move outwardly, e.g., away from a longitudinal axis of the assembly 100 and increase the inner width of the adjustable portion 104c. Accordingly, as illustrated in FIGS. IB and 1C, transitioning the assembly 100 from the third configuration 102c to the second configuration 102b can increase the inner width of the adjustable portion 104c from the third width W3 to the second width W2 which decreases the fluid resistance of the assembly 100 and, under a given pressure, can increase the flow rate of the fluid 101 through the assembly 100. Although described as moving between the second and third configurations, one skilled in the art will appreciate that the assembly 100 can be transitioned between any of the first and fourth configurations.
[0024] FIGS. 2 A and 2B illustrate perspective views of a flow control assembly 200 (“the assembly 200”) configured in accordance with various embodiments of the present technology. Specifically, FIG. 2A illustrates a perspective view of the assembly 200, and FIG. 2B illustrates an enlarged perspective view of a portion of the assembly 200 of FIG. 2A, with other aspects of the assembly 200 omitted for the purpose of clarity.
[0025] The assembly 200 can include certain features generally similar to or the same as corresponding features of the assembly 100 of FIGS. 1A-1D, with like numbers (e.g., adjustable portion 204c versus the adjustable portion 104c of FIGS. 1A-1D) indicating like or at least similar components. Relative to the assembly 100, however, the adjustable portion 204c of the assembly 200 is shown in FIG. 2A as having a membrane 209 extending between the first end portion 204a and the second end portion 204b of the body 204. In some embodiments, the membrane 209 can cover, extend around, at least partially contain, or otherwise include one or more longitudinal elements or spines (e.g., longitudinal elements 108 from FIGS. 1A-1D), as previously described with reference to FIGS. 1A-1D.
[0026] The assembly 200 further includes a housing 220 (which can also be referred to as a casing, a support structure, or the like). At least a portion of the body 204 can be positioned (e.g. housed) within and/or coupled to the housing 220. In some embodiments, the second end portion 204b of the body 204 can be fixed (e.g., rotationally fixed) relative to the housing 220, while the first end portion 204a of the body 204 can be configured to rotate relative to the housing 220. In FIG. 2A, the housing 220 is illustrated as semi-transparent (e.g., translucent) to better illustrate aspects of the assembly 200. In other embodiments, the housing 220 can be fully transparent or opaque. In these and other embodiments, the housing 220 can be formed from a rigid material, e.g., such that the housing 220 can have a greater stiffness than the adjustable portion 204c. Accordingly, the assembly 200 can be configured such that the adjustable portion 204c can transition between the configurations 102a-d described with reference to FIGS. 1A-1D without or substantially without rotation, twisting, and/or other deformations to the housing 220.
[0027] Although in the illustrated embodiment the housing 220 has a circular cross- sectional shape, in other embodiments the housing 220 can have an oval, triangular, square, rectangular, pentagonal, hexagonal, rectilinear, curvilinear, and/or any other suitable cross- sectional shape. In at least some embodiments, for example, the housing 220 can have a same cross-sectional shape as at least a portion (e.g., the first end portion 204a, the second end portion 204b, the adjustable portion 204c, and/or any other suitable portion) of the body 204. Although in the illustrated embodiment the first end portion 204a and the second end portion 204b of the body 204 have a square cross-sectional shape and the adjustable portion 204c has a circular cross- sectional shape, in other embodiments the first end portion 204a, the second end portion 204b, and the adjustable portion 204c of the body 204 can have a same cross-sectional shape, or one or more of the first end portion 204a, the second end portion 204b, and/or the adjustable portion 204c can have any other suitable cross-sectional shape.
[0028] The assembly 200 can further include a first fluid port or aperture (e.g., fluid inlet 222a) and a second fluid port or aperture (e.g., fluid outlet 222b) fluidly coupled to the lumen 205 defined by the body 204. In the illustrated embodiment, the fluid inlet 222a includes a tube or conduit fluidly coupled to the second end portion 204b of the body 204 and/or the housing 220, and the fluid outlet 222b includes an opening in the first end portion 204a of the assembly 200. In other embodiments, the fluid inlet 222a can be an opening in the second end portion 204b of the assembly 200, the fluid outlet 222b can include a tube or conduit fluidly coupled to the first end portion 204a of the body 204 and/or the housing 220, and/or the fluid inlet 222a and the fluid outlet 222b can each have any other suitable configuration.
[0029] The assembly 200 can further include an actuating or flow-control cap 224 (“the cap 224”). In the illustrated embodiment, the cap 224 is configured to receive (e.g., encircle, encompass, surround, contain, etc.) or otherwise couple to at least part of the first end portion 204a of the body 204. In other embodiments, the cap 224 can be configured to receive at least part of the second end portion 204b of the body 204. In at least some embodiments, for example, the cap 224 can be a first cap configured to receive at least a first part of the first end portion 204a of the body 204, and the assembly 200 can further include a second cap generally similar to or the same as the first cap and configured to receive at least a second part of the second end portion 204b of the body 204.
[0030] The cap 224 can be moveably (e.g., rotatably) coupled to the housing 220 and operably engaged with at least part of the first end portion 204a of the body 204, such that rotating the cap 224 can cause a corresponding rotation of the first end portion 204a of the body 204 without causing a corresponding rotation of the housing 220. In the illustrated embodiment, for example, the cap 224 has an inner perimeter 226 defining an opening or aperture sized and/or shaped to correspond to the size and/or shape of the first end portion 204a of the body 204. In other embodiments, the cap 224 and the first end portion 204a of the body 204 can form (e.g., be manufactured as) a single-piece component, the cap 224 can be coupled to the first end portion 204a of the body 204 via a friction fit, via one or more fasteners and/or adhesives, and/or via another mechanism that enables the rotation of the cap 224 to induce rotation of the first end portion 204a of the body.
[0031] In operation, fluid 201 can enter the assembly 200 (e.g., from a first body region) via the fluid inlet 222a, flow through the assembly 200 (e.g., through the body 204, similar to as described previously and with reference to FIGS. 1A-1D) in the direction shown in FIG. 2A, and exit the assembly 200 (e.g., into a second body region) via the fluid outlet 222b. In other embodiments, the assembly 200 can operate in reverse, e.g., such that the fluid 201 can enter the assembly 200 via the fluid outlet 222b, flow through the assembly in a direction opposite the direction shown in FIG. 2A, and exit the assembly via the fluid inlet 222a. The cap 224 can be rotated relative to the housing 220 to change the configuration of the assembly 200, e.g., by rotating the first end portion 204a of the body 204 relative to the second end portion 204b of the body 204 to adjust an inner width W of the adjustable portion 204c and control the corresponding fluid resistance and, under a given pressure, the flow rate of the fluid 201 through the assembly 200, as described previously and with reference to FIGS. 1A-1D. In at least some embodiments, for example, the second end portion 204b of the body 204 can be rotationally fixed to the housing 220 such that rotation of the first end portion 204a of the body 204 can cause the adjustable portion 204c to constrict or expand, e.g., decreasing or increasing the inner width W of the adjustable portion 204c as described previously and with reference to FIGS. 1A-1D. [0032] Referring to FIG. 2B, the cap 224 can include a first interface surface 228 (“the first surface 228”), the housing 220 can include a second interface surface 229 (“the second surface 229”), and the first surface 228 can be moveably and/or operably coupled to the second surface 229. The first and second surfaces 228, 229 can be configured to allow the cap 224 to be rotated in one or more increments, e.g., between the one or more configurations described previously above with reference to FIGS. 1 A-1D. In the illustrated embodiment, the first surface 228 includes one or more protrusions 228a (e.g., teeth, lobes, ridges, interface features etc.) and the second surface 229 includes one or more corresponding recesses 229a (e.g., recessed areas, valleys, interface features, etc.), and each of the recesses 229a is configured to receive at least one of the protrusions 228a. In other embodiments, the first surface 228 can include the recessed areas 229a and the second surface 229 can include corresponding protrusions 228a. Accordingly, the first surface 228 and the second surface 229 can both form a “sawtooth” configuration. In the illustrated embodiment, for example, the entire perimeter of the first surface 228 includes the protrusions 228a and only part of the perimeter of the second surface 229 includes the recesses 229a. In other embodiments, however, only part of the perimeter of the first surface 228 can include the productions 228a and the entire perimeter of the second surface 229 can include the recesses 229a. Although in the illustrated embodiment the first and second surfaces 228, 229 have, respectively, generally linear protrusions 228a and recesses 229a, in other embodiments, the first surface 228 and/or the second surface 229 can have, respectively, generally curved or arcuate protrusions 228a and recesses 229a, and/or have protrusions 228a and recesses 229a with any other suitable configuration. In these and other embodiments, the first surface 228 and the second surface 229 can be generally similar or the same, such that the first surface 228 and the second surface 229 can have a generally similar or a same configuration but be rotationally (e.g., radially, axially, etc.) offset from each other. For example, the recesses 229a can be recessed areas between individual ones of the protrusions 228a and/or the protrusions 228a can be ridges separating individual ones of the recesses 229a. In further embodiments, individual ones of the protrusions 228a and/or the recesses 229a can have any other suitable configuration, dimensions, spacing (e.g., uniformly spaced, non-uniformly or variably spaced, etc.), and/or alignment relative to each other.
[0033] In operation, when the cap 224 is rotated (e.g., in a first direction R1 or a second direction R2), individual ones (e.g., one or more, a plurality, each, etc.) of the protrusions 228a can advance from a first recess to a second (e.g., neighboring, next, nearest, proximate, etc.) recess. Further rotation of the cap 224 can translate individual ones of the protrusions 228a through additional recesses 229a. Advancing the protrusions 228a from the first recess to the second recess can represent a single rotational increment or unit, and each rotational increment can be associated with a configuration of the body 204, a corresponding inner width W of the adjustable portion 204c, and the associated fluid resistance and/or flow rate. Each rotational increment can be based on the respective configuration of individual ones of the protrusions 228a and/or the recesses 229a. In some embodiments, for example, all of the protrusions 228a and recesses 229a are the same or substantially the same such that each of the rotational increments represents a same or substantially the same increment of rotation of the cap 224 and a corresponding same or substantially the same increment of change to the assembly 200 (e.g., a same increment of change to the configuration, inner width W, fluid resistance, etc.). In other embodiments, at least one of the protrusions 228a and/or recesses 229a can be differently sized and/or non-uniformly spaced compared to the other protrusions 228a and/or recesses 229a, such that at least one of the rotational increments represents a greater or lesser increment of rotation of the cap 224 compared to other rotational increments and a correspondingly greater or lesser increment of change to the assembly 200 (e.g., a greater or lesser increment of change to the configuration, inner width W, fluid resistance, etc.) compared to other changes to the assembly 200. Accordingly, assemblies configured in accordance with embodiments of the present technology are expected to allow for repeated and/or consistent transitioning between various configurations, e.g., to provide an adjustable therapy to a patient. Additionally, the interaction between the protrusions 228a and the recesses 229a can at least partially or fully prevent unwanted or unintended rotation of the cap 224 and/or the first end portion 204a, which, in turn, can at least partially or fully prevent unwanted or unintended changes to the inner width W of the adjustable portion 204c. In at least some embodiments, for example, the protrusions 228a and/or the recesses 229a can be configured such that, after rotating a given number of increments, the protrusions 228a and/or the recesses 229a can interface to at least partially or fully prevent further rotation of the cap 224 and/or the first end portion 204a, e.g., to maintain the adjustable portion 204c at a given inner width W.
[0034] FIG. 3 illustrates a partially schematic top view of an actuation mechanism 330 configured in accordance with various embodiments of the present technology. The actuation mechanism 330 can be at least a portion of a flow control assembly, such as the assembly 100 of FIGS. 1 A-1D, the assembly 200 of FIGS. 2A and 2B, or any other suitable flow control assembly, and can be used to selectively drive rotation of the assembly 100 and/or the assembly 200 through various configurations to adjust the fluid resistance provided by the respective flow control assembly 100, 200. [0035] The actuation mechanism 330 can include a driven element 332, a drive element or pall 338, and one or more actuation elements 334a-b (shown as a first actuation element 334a and a second actuation element 334b in FIG. 3). The actuation element(s) 334a-b and the pall 338 can be operably coupled to the driven element 332. The driven element 332 can be coupled to the cap 224 (FIGS. 2 A and 2B) and/or the first end portion 104a, 204a of the body 104, 204 (FIGS. 1A- 2A) such that, as described in greater detail below, the actuation element(s) 334a-b and the pall 338 can be operable to rotate the driven element 332 and the cap 224, e.g., to transition the assembly 100, 200 (FIGS. 1 A-2B) between one or more of the configurations 102a-d (FIGS. 1 A- 1D).
[0036] The driven element 332 can include an axis 336 and one or more engagement features 342 positioned radially about an outer perimeter of the driven element 332. Each of the engagement features 342 can include a first surface 344a (e.g., a drive surface) and a second surface 344b (e.g., a return surface) opposite the drive surface 344a. In the illustrated embodiment, the driven element 332 includes ten engagement features 342. In other embodiments, the driven element 332 can include more or fewer engagement features 342, such as less than ten engagement features, more than ten engagement features, and/or any other suitable number of engagement features 342. In at least some embodiments, the number of engagement features 342 can correspond to the number of configurations 102 of the assembly 100 or the assembly 200. Although in the illustrated embodiment each of the engagement features 342 is illustrated as having generally similar or the same dimensions, in other embodiments one or more of the engagement features can have at least one different dimension (e.g., individual ones of the engagement features 342 can have differing sizes, spacing, etc.). As described in greater detail below, each of the engagement features 342 can correspond to a rotational increment of a cap and/or a configuration of a flow control assembly, such as the rotational increments of the cap 224 and/or the configurations of the assembly 200 described previously and with reference to FIGS. 2 A and 2B.
[0037] Each of the actuation elements 334a-b can include a first end portion coupled to the pall 338. In the illustrated embodiment, for example, a first end portion 334ai of the first actuation element 334a is coupled to a first side 340a of the pall 338, and a first end portion 334bi of the second actuation element 334b is coupled to a second side 340b of the pall 338 opposite the first side 340a. Each of the actuation elements 334a-b further include a respective second end portion 334a2, 334b2 opposite and spaced apart from the corresponding first end portions 334ai, 334bi. Additionally, each of the second end portions 334a2, 334b2 of the actuation elements 334a-b can have a fixed position, e.g., relative to the axis 336 of the driven element 332. In at least some embodiments, for example, the second end portions 334a2, 334b2 can be coupled to an interior surface of the housing 220 (FIGS. 2A and 2B), or any other suitable portion of the assembly 200 (FIGS. 2A and 2B). Each of the actuation elements 334a-b can be actuated to move the pall 338 to contact at least a portion of one of the engagement features 342 (e.g., at least a portion of the drive surface 344a or the return surface 344b) of the driven element 332. As described in greater detail below, actuating the actuation elements 334a-b can drive rotation (e.g., incremental rotation, gradual rotation, etc.) of the driven element 332.
[0038] Each of the actuation elements 334a-b can be composed at least partially of a shape memory material or alloy (e.g., nitinol). Accordingly, each actuation element 334a-b can be transitionable at least between a first material phase or state (e.g., a martensitic state, a R-phase, a composite state between martensitic and R-phase, etc.) and a second material phase or state (e.g., an austenitic state, an R-phase state, a composite state between austenitic and R-phase, etc.). In the first material state, the actuation elements 334a-b may have reduced (e.g., relatively less stiff) mechanical properties that cause the actuation elements to be more easily deformable (e.g., compressible, expandable, etc.) relative to when the actuation elements are in the first material state. In the second material state, the actuation elements 334a-b may have increased (e.g., relatively stiffer) mechanical properties relative to the first material state, causing an increased preference toward a specific preferred geometry (e.g., original geometry, manufactured or fabricated geometry, heat set geometry, etc.). In the illustrated embodiment, the first actuation element 334a and the second actuation element 334b can be selectively and independently transitioned between the first material state and the second material state by applying energy (e.g., laser energy, electrical energy, etc.) to the first actuation element 334a or the second actuation element 334b to heat it above a transition temperature (e.g., above an austenite finish (Af) temperature, which is generally greater than body temperature). If the first actuation element 334a (or the second actuation element 334b) is deformed relative to its preferred geometry when heated above the transition temperature, the first actuation element 334a (or the second actuation element 334b) will move to and/or toward its preferred geometry. In some embodiments, the first actuation element 334a and the second actuation element 334b are operably coupled such that, when the actuated actuation element (e.g., the first actuation element 334a) transitions toward its preferred geometry, the non-actuated actuation element (e.g., the second actuation element 334b) is further deformed relative to its preferred geometry. [0039] The first actuation element 334a and the second actuation element 334b generally act in opposition. For example, the first actuation element 334a can be actuated to move the pall 338 in a first direction DI, and the second actuation element 334b can be actuated to move the pall 338 in a second direction D2 generally or substantially opposite the first direction DI. Additionally, as described above, the first actuation element 334a and the second actuation element 334b can be coupled such that, as one moves toward its preferred geometry upon material phase transition, the other is deformed relative to its preferred geometry. This enables the actuation elements 334a-b to be repeatedly actuated and the pall 338 to be repeatedly cycled in the first direction DI and the second direction D2.
[0040] Additional details regarding the operation of shape memory actuators for use with adjustable shunts are described in U.S. Patent Application No. 17/175,332, U.S. Patent App. Publication No. 2020/0229982, and International Patent Application Nos. PCT/US20/55144, PCT/US20/55141, PCT/US21/14774, PCT/US21/18601, PCT/US21/23238, and
PCT/US21/27742, the disclosures of which are incorporated by reference herein in their entireties and for all purposes.
[0041] In operation, each of the actuation elements 334a-b can be actuated to drive movement of the pall 338 relative to the axis 336 of the driven element 332, e.g., to drive rotation of the driven element 332 in a direction indicated by arrow A. In the illustrated embodiment, for example, the actuation mechanism 330 can be configured such that, when the first actuation element 334a is heated above its transition temperature, the first end portion 334ai of the first actuation element 334a moves in the first direction DI as the first actuation element 334a moves to and/or toward its preferred geometry. The movement of the first actuation element 334a to and/or toward its preferred geometry can drive the pall 338 in the first direction DI. As the pall 338 moves in the first direction DI, the pall 338 (e.g., the second side 340b of the pall 338) can contact a drive surface 344ai of a first engagement feature 342a. The drive surface 344ai can be configured such that the movement of the pall 338 in the first direction DI can drive rotation of the first engagement feature 342a in the rotation direction A which, in turn, can cause the driven element 332 to rotate about the axis 336 in the rotation direction A. As described previously, the driven element 332 can be coupled to the cap 224 of the assembly 200 of FIGS. 2A and 2B such that the rotation of the driven element 332 can adjust (e.g., decrease or increase) the inner width W of the adjustable portion 204c of the body 204. Additionally, and as described previously and with reference to FIG. 2B, the interaction between the first surface 228 and the second surface 229 can at least partially or fully prevent the driven element 332 from unwanted or unintended rotation, e.g., from rotating in the rotation direction A or in a direction opposite the rotation direction A. However, the force induced on the cap 224 by the driven element 332 in response to actuation of the first actuation element 334a can be sufficient to overcome the static friction force between the first surface 228 and the second surface 229. Accordingly, the driven element 332 (and thus the cap 224) can rotate in response to actuation of one or more of the actuation elements 334a-b.
[0042] The actuation mechanism 330 can be further configured such that, when the second actuation element 334b is heated above its transition temperature, the first end portion 334bi of the second actuation element 334b moves in the second direction D2 (e.g., opposite the first direction DI) as the second actuation element 334b moves to and/or towards its preferred geometry. The movement of first end portion 334bi in the second direction D2 can drive the pall 338 in the second direction D2. As the pall 338 moves in the second direction D2, the pall 338 can translate across a return surface 344b2 of a second engagement feature 342b to and/or toward a drive surface 344a2 of the second engagement feature 342b. In at least some embodiments, for example, the second actuation element 334b can be sized and/or positioned such that the pall 338 contacts the drive surface 344a2 and/or a return surface 344bs of a third engagement feature 342c when the second actuation element 334b is at or near its preferred geometry. As described previously, the first and second actuation elements 334a-b can act in opposition. Accordingly, the movement of the pall 338 in the second direction D2 can reset the actuation mechanism 330 (e.g., deforming the first actuation element 334a relative to its preferred geometry), such that the actuation mechanism 330 can be repeatedly actuated, with each successive actuation cycle being generally similar to or the same as the actuation cycle described above, e.g., to drive further rotation of the driven element 332. Additionally, in embodiments where the driven element 332 is coupled to the cap 224 of the assembly 200 of FIGS. 2A and 2B, the interaction between the first surface 228 and the second surface 229 can prevent unwanted and/or unintended rotation of the driven element 332 while the pall 338 translates across the second return surface 344b2 in the second direction D2, as described previously.
[0043] In these and other embodiments, the actuation mechanism 330 can be configured to operate in reverse, such that the second actuation element 334b can be heated above its transition temperature to move the pall 338 in the first direction DI and rotate the driven element 332, and the first actuation element 334a can be heated above its transition temperature to move the pall 338 in the second direction D2 and reset the actuation mechanism 330. [0044] In some embodiments, a plurality of actuation mechanisms 330 can be used as part of a flow control assembly. For example, referring to FIGS. 2A-3, in at least some embodiments the assembly 200 can include a first actuation mechanism operable to rotate the first end portion 204a of the body 204 in a direction to decrease the inner width W of the adjustable portion 204c, and a second actuation mechanism operable to rotate the second end portion 204b of the body in the same direction to increase the inner width W of the adjustable portion 204c.
[0045] FIG. 4 is a perspective view of another flow control assembly 400 (“the assembly 400”) configured in accordance with various embodiments of the present technology. The assembly 400 can be generally similar to or the same as the assembly 100 of FIGS. 1 A-1D and/or the assembly 200 of FIGS. 2A and 2B, with like numbers (e.g., the body 404 versus the body 104 of FIGS. 1A-1D, the body 204 of FIGS. 2A-2B). However, the assembly 400 can include a cap 424 that is supported by a central axis or shaft 425. The shaft 425 can extend at least partially or fully through a body 404 and/or a first (e.g., inner) housing 420 of the assembly 400, and can be rotatably coupled to the body 404 (e.g., a first end portion of the body 404; not shown) and/or the first housing 420. The cap 424 can include a first surface 428 configured to allow for incremental rotation of the cap 424 about the shaft 425. The cap 424 can also include an opening 422 that can serve as a fluid inlet or a fluid outlet of the assembly 400. Although in the illustrated embodiment the opening 422 includes four fan-shaped apertures in the cap 424, each extending radially from the shaft 425, in other embodiments the opening can include more or fewer fan-shaped apertures, and/or apertures of any other suitable shape and/or position relative to the shaft 425.
[0046] In some embodiments, the assembly 400 can include a second (e.g., outer) housing 421. The second housing 421 can be configured to contain at least a portion of the first housing 420 and/or at least a portion the body 404. In the illustrated embodiment, for example, a first end portion (not shown) of the body 404 is positioned within the second housing 421. The second housing 421 (e.g., an interior region of the second housing 421), and/or a portion of the first housing 420 positioned within the second housing 421, can include a second surface (not shown) which can be generally similar to or the same as the second surface 229 of FIG. 2B and can be operably coupled to the first surface 428, such that the second surface can allow for incremental rotation of the cap 424 about the shaft as described previously. Although depicted as having a gap between the cap 424 and the second housing 421 in FIG. 4 to better illustrate aspects of the assembly 400, in other embodiments the cap 424 can be at least partially or fully received by the second housing 421, such that generally or substantially all fluid flowing through the assembly 400 passes through the opening 422 in the cap 424. [0047] As one skilled in the art will appreciate, one or more of the flow control assemblies and/or actuation mechanisms described above can be used as part of an adjustable shunting system, e.g., to control the flow of fluid therethrough. Moreover, certain features described with respect to one flow control assembly or actuation mechanism can be added or combined with another flow control assembly or actuation mechanism. Accordingly, the present technology is not limited to the flow control assemblies and actuation mechanisms expressly identified herein. For example, in some embodiments the flow control assemblies and actuation mechanisms described herein could be utilized with the adjustable shunting systems and actuation assemblies described in U.S. Patent Application No. 17/175,332, U.S. Patent App. Publication No. 2020/0229982, and International Patent Application Nos. PCT/US20/55144, PCT7US20/55141, PCT/US21/14774, PCT/US21/18601, PCT/US21/023238, and
PCT/US21/27742, the disclosures of which were previously incorporated by reference herein in their entireties and for all purposes. Accordingly, flow control assemblies and actuation mechanisms in accordance with embodiments of the present technology can be used with any of the adjustable shunting systems incorporated by reference.
Examples
[0048] Several aspects of the present technology are set forth in the following examples:
1. A flow control assembly for use with a shunting system for shunting fluid between a first body region and a second body region, the flow control assembly comprising: a hollow body having a first end portion, a second end portion opposite the first end portion, and an adjustable portion extending between the first end portion and the second end portion, wherein the adjustable portion has an inner dimension that corresponds to a fluid resistance of the flow control assembly; and an actuation mechanism operably coupled to the body, wherein the actuation mechanism is configured to rotate the first end portion of the body relative to the second end portion of the body to change the inner dimension of the adjustable portion of the body.
2. The flow control assembly of example 1 wherein the actuation mechanism is configured to increase the inner dimension when actuated. 3. The flow control assembly of example 1 or example 2 wherein the actuation mechanism is configured to decrease the inner dimension when actuated.
4. The flow control assembly of any of examples 1-3, further comprising a housing, wherein at least a portion of the body is positioned within the housing.
5. The flow control assembly of example 4 wherein the first end portion of the body is operably coupled to the housing and configured to rotate relative to the housing.
6. The flow control assembly of example 4 or example 5, further comprising a cap coupled to the first end portion of the body.
7. The flow control assembly of example 6 wherein the cap includes an inner perimeter configured to receive at least part of the first end portion of the body.
8. The flow control assembly of example 6 or example 7 wherein the cap includes a first surface, the housing includes a second surface, and the first surface is operably coupled to the second surface.
9. The flow control assembly of example 8 wherein the first surface includes one or more protrusions, the second surface includes one or more recesses, and each of the one or more protrusions are configured to releasably receive at least one of the one or more recesses.
10. The flow control assembly of example 9 wherein, for a given one of the protrusions, the actuation mechanism is configured to move the protrusion from a first recess to a second recess to cause the first end portion of the body to rotate relative to the housing and the second end portion of the body.
11. The flow control assembly of example 10 wherein the second recess is adjacent to the first recess.
12. The flow control assembly of any of examples 8-11 wherein: the first surface includes a first plurality of teeth, the second surface includes a second plurality of teeth, and the second plurality of teeth are configured to releasably couple the first plurality of teeth.
13. The flow control assembly of example 12 wherein the second plurality of teeth have a same configuration as the first plurality of teeth and are rotationally offset from the first plurality of teeth such that individual ones of the second plurality of teeth releasably interface with individual ones of the first plurality of teeth.
14. The flow control assembly of example 12 wherein one or more of the second plurality of teeth have a different configuration than one or more of the first plurality of teeth.
15. The flow control assembly of any of examples 12-14 wherein the actuation mechanism is operable to rotate the first plurality of teeth relative to the second plurality of teeth to cause the first end portion of the body to rotate relative to the housing and the second end portion of the body.
16. The flow control assembly of any of examples 4-15 wherein the first end portion of the body and the housing are configured such that the actuation mechanism is operable to rotate the first end portion of the body between one or more increments, wherein each increment corresponds to a different inner dimension of the adjustable portion.
17. The flow control assembly of any of examples 1-16 wherein the body includes a plurality of longitudinal elements extending at least partially between the first end portion and the second end portion.
18. The flow control assembly of example 17 wherein the actuation mechanism is configured to rotate at least a portion of the longitudinal elements relative to a longitudinal axis of the body to change the inner dimension of the adjustable portion of the body.
19. An adjustable shunting system for draining fluid from a first body region to a second body region, the adjustable shunting system comprising: a housing; and a body positioned at least partially within the housing, the body defining an adjustable lumen having an adjustable minimum dimension; wherein a first portion of the body is configured to rotate relative to the housing and a second portion of the body is configured to remain stationary relative to the housing, such that the body is configured to transition between — a first configuration where the adjustable lumen has a first minimum dimension, and a second configuration where the adjustable lumen has a second minimum dimension.
20. The adjustable shunting system of example 19 wherein the second minimum dimension is less than the first minimum dimension.
21. The adjustable shunting system of example 19 or example 20 wherein the second minimum dimension is greater than the first minimum dimension.
22. The adjustable shunting system of any of examples 19-21 wherein: the first portion of the body is opposite and spaced apart from the second portion of the body; the second portion includes a fluid inlet; the first portion includes a fluid outlet; and the adjustable lumen is configured to receive fluid via the fluid inlet and drain fluid from the adjustable shunting system via the fluid outlet.
23. The adjustable shunting system of any of examples 19-22, further comprising an actuating cap operably coupled to the housing and the body.
24. The adjustable shunting system of example 23, wherein the actuating cap is configured to rotate in concert with the first portion of the body and relative to the housing.
25. The adjustable shunting system of example 23 or example 24 wherein the actuating cap includes a rotation-based actuation mechanism configured to rotate the actuating cap and at least the first portion of the body relative to the housing. 26. The adjustable shunting system of any of examples 23-25 wherein the actuating cap is configured to rotate the first portion of the body relative to the housing and through one or more increments to adjust the inner width of the adjustable lumen.
27. The adjustable shunting system of example 26 wherein at least one of the one of the one or more increments corresponds to rotating the body between the first configuration and the second configuration.
28. The adjustable shunting system of any of examples 19-27 wherein the adjustable lumen includes a plurality of longitudinal elements extending at least partially between the first portion of the body and the second portion of the body.
29. The adjustable shunting system of example 28 wherein the longitudinal elements are configured to rotate relative to a longitudinal axis of the body when the body transitions between the first configuration and the second configuration.
30. The adjustable shunting system of any of examples 19-29 wherein, in the first configuration, the body has a generally cylindrical shape.
31. The adjustable shunting of any of examples 19-30 wherein, in the second configuration, the body has a generally hourglass shape.
32. The adjustable shunting system of any of examples 19-31 wherein: in the first configuration, the first minimum dimension is at a central region of the adjustable lumen, and in the second configuration, the second minimum dimension is at the central region of the adjustable lumen.
33. A method for selectively controlling fluid flow from a first body region to a second body region through a shunting system having a flow control assembly, the method comprising: applying energy to an actuation element of an actuation mechanism of the flow control assembly; and in response to the applied energy, rotating a driven element of the actuation mechanism, wherein rotating the driven element includes rotating a first end of the adjustable portion relative to a second end of the adjustable portion to change an inner dimension of an adjustable portion of the flow control assembly.
34. The method of example 33 wherein rotating the driven element includes transitioning the adjustable portion between a first configuration in which the adjustable portion has a first inner dimension and a second configuration in which the adjustable portion has a second inner dimension less than the first inner dimension.
35. The method of example 34 wherein applying energy to the actuation element includes moving a pall of the actuation mechanism in a first direction to drive rotation of the driven element.
36. The method of example 35 wherein the actuation element is a first actuation element, the method further comprising: applying energy to a second actuation element of the actuation mechanism; and in response to the applied energy, moving the pall in a second direction opposite the first direction to reset the actuation mechanism.
37. The method of any of examples 33-36 wherein rotating the first end of the adjustable portion relative to the second end of the adjustable portion includes rotating at least a portion of one or more longitudinal elements of the flow control assembly relative to a longitudinal axis of the adjustable portion, the one or more longitudinal elements extending at least partially between the first end and the second end.
38. The method of any of examples 33-37 wherein rotating the first end of the adjustable portion relative to the second end of the adjustable portion includes decreasing the inner dimension of the adjustable portion at a center region of the adjustable portion. 39. An adjustable shunting system for draining fluid in a patient, the adjustable shunting system comprising: a hollow body including a flexible membrane and a plurality of longitudinal elements, the flexible membrane and the plurality of longitudinal elements defining an adjustable lumen, wherein a first portion of the body is configured to rotate relative to a second portion of the body such that the body is transitionable between a first generally cylindrical shape and a second generally hourglass shape, wherein, in the first generally cylindrical shape, the adjustable lumen has a first minimum dimension, and wherein, in the second generally hourglass shape, the adjustable lumen as a second minimum dimensions less than the first minimum dimension.
40. The adjustable shunting system of example 39 wherein: in the first generally cylindrical shape, the first minimum dimension is at a center region of the adjustable lumen, and in the second generally hourglass shape, the second minimum dimension is at the center region of the adjustable lumen.
41. The adjustable shunting system of example 39 or example 40 wherein the flexible membrane and the plurality of longitudinal elements are configured to rotate at least partially about the longitudinal axis of the body.
42. The adjustable shunting system of any of examples 39-41 wherein individual ones of the plurality of longitudinal elements extend lengthwise along the hollow body and, in the first generally cylindrical shape, are generally parallel to the longitudinal axis of the body.
43. The adjustable shunting system of any of examples 39-42 wherein the body is transitionable through a plurality of incremental shapes between the first generally cylindrical shape and the second generally hourglass shape. 44. The adjustable shunting system of example 43, further comprising an actuation mechanism configured to incrementally transition the body through the plurality of incremental shapes.
Conclusion
[0049] The above detailed description of embodiments of the technology are not intended to be exhaustive or to limit the technology to the precise form disclosed above. Although specific embodiments of, and examples for, the technology are described above for illustrative purposes, various equivalent modifications are possible within the scope of the technology as those skilled in the relevant art will recognize. For example, any of the features of the adjustable shunting systems described herein may be combined with any of the features of the other adjustable shunting systems herein and vice versa. Moreover, 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.
[0050] From the foregoing, it will be appreciated that specific embodiments of the technology have been described herein for purposes of illustration, but well-known structures and functions associated with adjustable shunting systems have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology. Where the context permits, singular or plural terms may also include the plural or singular term, respectively.
[0051] 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 types 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 embodiments may also exhibit such advantages, and not all embodiments need necessarily exhibit such advantages to fall within the scope of the technology. Accordingly, the disclosure and associated technology can encompass other embodiments not expressly shown or described herein.

Claims

CLAIMS I/W e claim:
1. A flow control assembly for use with a shunting system for shunting fluid between a first body region and a second body region, the flow control assembly comprising: a hollow body having a first end portion, a second end portion opposite the first end portion, and an adjustable portion extending between the first end portion and the second end portion, wherein the adjustable portion has an inner dimension that corresponds to a fluid resistance of the flow control assembly; and an actuation mechanism operably coupled to the body, wherein the actuation mechanism is configured to rotate the first end portion of the body relative to the second end portion of the body to change the inner dimension of the adjustable portion of the body.
2. The flow control assembly of claim 1 wherein the actuation mechanism is configured to increase the inner dimension when actuated.
3. The flow control assembly of claim 1 wherein the actuation mechanism is configured to decrease the inner dimension when actuated.
4. The flow control assembly of claim 1, further comprising a housing, wherein at least a portion of the body is positioned within the housing.
5. The flow control assembly of claim 4 wherein the first end portion of the body is operably coupled to the housing and configured to rotate relative to the housing.
6. The flow control assembly of claim 4, further comprising a cap coupled to the first end portion of the body.
7. The flow control assembly of claim 6 wherein the cap includes an inner perimeter configured to receive at least part of the first end portion of the body.
-27-
8. The flow control assembly of claim 6 wherein the cap includes a first surface, the housing includes a second surface, and the first surface is operably coupled to the second surface.
9. The flow control assembly of claim 8 wherein the first surface includes one or more protrusions, the second surface includes one or more recesses, and each of the one or more protrusions are configured to releasably receive at least one of the one or more recesses.
10. The flow control assembly of claim 9 wherein, for a given one of the protrusions, the actuation mechanism is configured to move the protrusion from a first recess to a second recess to cause the first end portion of the body to rotate relative to the housing and the second end portion of the body.
11. The flow control assembly of claim 10 wherein the second recess is adj acent to the first recess.
12. The flow control assembly of claim 8 wherein: the first surface includes a first plurality of teeth, the second surface includes a second plurality of teeth, and the second plurality of teeth are configured to releasably couple the first plurality of teeth.
13. The flow control assembly of claim 12 wherein the second plurality of teeth have a same configuration as the first plurality of teeth and are rotationally offset from the first plurality of teeth such that individual ones of the second plurality of teeth releasably interface with individual ones of the first plurality of teeth.
14. The flow control assembly of claim 12 wherein one or more of the second plurality of teeth have a different configuration than one or more of the first plurality of teeth.
15. The flow control assembly of claim 12 wherein the actuation mechanism is operable to rotate the first plurality of teeth relative to the second plurality of teeth to cause the first end portion of the body to rotate relative to the housing and the second end portion of the body.
16. The flow control assembly of claim 4 wherein the first end portion of the body and the housing are configured such that the actuation mechanism is operable to rotate the first end portion of the body between one or more increments, wherein each increment corresponds to a different inner dimension of the adjustable portion.
17. The flow control assembly of claim 1 wherein the body includes a plurality of longitudinal elements extending at least partially between the first end portion and the second end portion.
18. The flow control assembly of claim 17 wherein the actuation mechanism is configured to rotate at least a portion of the longitudinal elements relative to a longitudinal axis of the body to change the inner dimension of the adjustable portion of the body.
19. An adjustable shunting system for draining fluid from a first body region to a second body region, the adjustable shunting system comprising: a housing; and a body positioned at least partially within the housing, the body defining an adjustable lumen having an adjustable minimum dimension; wherein a first portion of the body is configured to rotate relative to the housing and a second portion of the body is configured to remain stationary relative to the housing, such that the body is configured to transition between — a first configuration where the adjustable lumen has a first minimum dimension, and a second configuration where the adjustable lumen has a second minimum dimension.
20. The adjustable shunting system of claim 19 wherein the second minimum dimension is less than the first minimum dimension.
21. The adjustable shunting system of claim 19 wherein the second minimum dimension is greater than the first minimum dimension.
22. The adjustable shunting system of claim 19 wherein: the first portion of the body is opposite and spaced apart from the second portion of the body; the second portion includes a fluid inlet; the first portion includes a fluid outlet; and the adjustable lumen is configured to receive fluid via the fluid inlet and drain fluid from the adjustable shunting system via the fluid outlet.
23. The adjustable shunting system of claim 19, further comprising an actuating cap operably coupled to the housing and the body.
24. The adjustable shunting system of claim 23, wherein the actuating cap is configured to rotate in concert with the first portion of the body and relative to the housing.
25. The adjustable shunting system of claim 23 wherein the actuating cap includes a rotation-based actuation mechanism configured to rotate the actuating cap and at least the first portion of the body relative to the housing.
26. The adjustable shunting system of claim 23 wherein the actuating cap is configured to rotate the first portion of the body relative to the housing and through one or more increments to adjust the inner width of the adjustable lumen.
27. The adjustable shunting system of claim 26 wherein at least one of the one of the one or more increments corresponds to rotating the body between the first configuration and the second configuration.
28. The adjustable shunting system of claim 19 wherein the adjustable lumen includes a plurality of longitudinal elements extending at least partially between the first portion of the body and the second portion of the body.
29. The adjustable shunting system of claim 28 wherein the longitudinal elements are configured to rotate relative to a longitudinal axis of the body when the body transitions between the first configuration and the second configuration.
30. The adjustable shunting system of claim 19 wherein, in the first configuration, the body has a generally cylindrical shape.
31. The adj ustable shunting of claim 19 wherein, in the second configuration, the body has a generally hourglass shape.
32. The adjustable shunting system of claim 19 wherein: in the first configuration, the first minimum dimension is at a central region of the adjustable lumen, and in the second configuration, the second minimum dimension is at the central region of the adjustable lumen.
33. A method for selectively controlling fluid flow from a first body region to a second body region through a shunting system having a flow control assembly, the method comprising: applying energy to an actuation element of an actuation mechanism of the flow control assembly; and in response to the applied energy, rotating a driven element of the actuation mechanism, wherein rotating the driven element includes rotating a first end of the adjustable portion relative to a second end of the adjustable portion to change an inner dimension of an adjustable portion of the flow control assembly.
34. The method of claim 33 wherein rotating the driven element includes transitioning the adjustable portion between a first configuration in which the adjustable portion has a first inner dimension and a second configuration in which the adjustable portion has a second inner dimension less than the first inner dimension.
35. The method of claim 34 wherein applying energy to the actuation element includes moving a pall of the actuation mechanism in a first direction to drive rotation of the driven element.
36. The method of claim 35 wherein the actuation element is a first actuation element, the method further comprising: applying energy to a second actuation element of the actuation mechanism; and
-31- in response to the applied energy, moving the pall in a second direction opposite the first direction to reset the actuation mechanism.
37. The method of claim 33 wherein rotating the first end of the adjustable portion relative to the second end of the adjustable portion includes rotating at least a portion of one or more longitudinal elements of the flow control assembly relative to a longitudinal axis of the adjustable portion, the one or more longitudinal elements extending at least partially between the first end and the second end.
38. The method of claim 33 wherein rotating the first end of the adjustable portion relative to the second end of the adjustable portion includes decreasing the inner dimension of the adjustable portion at a center region of the adjustable portion.
39. An adjustable shunting system for draining fluid in a patient, the adjustable shunting system comprising: a hollow body including a flexible membrane and a plurality of longitudinal elements, the flexible membrane and the plurality of longitudinal elements defining an adjustable lumen, wherein a first portion of the body is configured to rotate relative to a second portion of the body such that the body is transitionable between a first generally cylindrical shape and a second generally hourglass shape, wherein, in the first generally cylindrical shape, the adjustable lumen has a first minimum dimension, and wherein, in the second generally hourglass shape, the adjustable lumen as a second minimum dimensions less than the first minimum dimension.
40. The adjustable shunting system of claim 39 wherein: in the first generally cylindrical shape, the first minimum dimension is at a center region of the adjustable lumen, and in the second generally hourglass shape, the second minimum dimension is at the center region of the adjustable lumen.
-32-
41. The adjustable shunting system of claim 39 wherein the flexible membrane and the plurality of longitudinal elements are configured to rotate at least partially about the longitudinal axis of the body.
42. The adjustable shunting system of claim 39 wherein individual ones of the plurality of longitudinal elements extend lengthwise along the hollow body and, in the first generally cylindrical shape, are generally parallel to the longitudinal axis of the body.
43. The adjustable shunting system of claim 39 wherein the body is transitionable through a plurality of incremental shapes between the first generally cylindrical shape and the second generally hourglass shape.
44. The adjustable shunting system of claim 43, further comprising an actuation mechanism configured to incrementally transition the body through the plurality of incremental shapes.
-33-
PCT/US2021/055258 2021-10-15 2021-10-15 Flow control assemblies with adjustable lumens for adjustable shunting systems, and associated systems, methods and devices WO2023063961A1 (en)

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US20150142049A1 (en) * 2013-11-21 2015-05-21 Edwards Lifesciences Corporation Sealing devices, related delivery apparatuses, and uses thereof
US20150313603A1 (en) * 2014-05-01 2015-11-05 Cook Medical Technologies Llc Implantable medical device with twisted element
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US4401107A (en) * 1982-04-20 1983-08-30 Haber Terry M Intestinal control valve
US6789447B1 (en) * 1998-11-23 2004-09-14 Frederick L. Zinck Reversible ratchet head assembly
US20150142049A1 (en) * 2013-11-21 2015-05-21 Edwards Lifesciences Corporation Sealing devices, related delivery apparatuses, and uses thereof
US20150313603A1 (en) * 2014-05-01 2015-11-05 Cook Medical Technologies Llc Implantable medical device with twisted element
US20190121278A1 (en) * 2017-10-20 2019-04-25 Canon Kabushiki Kaisha Driving force transmitting device, sheet feeding apparatus and image forming apparatus

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