WO2024108125A2 - Systèmes de dérivation réglables et leurs procédés de fabrication - Google Patents

Systèmes de dérivation réglables et leurs procédés de fabrication Download PDF

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Publication number
WO2024108125A2
WO2024108125A2 PCT/US2023/080290 US2023080290W WO2024108125A2 WO 2024108125 A2 WO2024108125 A2 WO 2024108125A2 US 2023080290 W US2023080290 W US 2023080290W WO 2024108125 A2 WO2024108125 A2 WO 2024108125A2
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WO
WIPO (PCT)
Prior art keywords
actuator
assembly
flow control
shape memory
control element
Prior art date
Application number
PCT/US2023/080290
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English (en)
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WO2024108125A3 (fr
Inventor
Tom Saul
Sateeshchandra BAJIKAR
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
Publication of WO2024108125A2 publication Critical patent/WO2024108125A2/fr
Publication of WO2024108125A3 publication Critical patent/WO2024108125A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F9/00—Methods 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
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/00781—Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body

Definitions

  • the present technology generally relates to implantable medical devices and, in particular, to adjustable shunting systems for promoting 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.
  • shunting systems have been proposed for treating glaucoma.
  • the flow of fluid through the shunting systems is primarily controlled by the pressure gradient across the shunt and the phy sical characteristics of the flow path defined through the shunt (e g., the resistance of the shunt lumen).
  • MIGS minimally invasive glaucoma shunts
  • shunting systems capable of adjusting the therapy provided, including the flow rate/fluid resistance between the two fluidly connected bodies.
  • a shunting system capable of being modified after manufacture (e g., in the clinic) to personalize the system for the patient and/or as part of the clinician's plan for the implant procedure.
  • FIG. 1A illustrates an adjustable shunting system configured in accordance with select embodiments of the present technology.
  • FIG. IB is an exploded view of the adjustable shunting system of FIG. 1 A.
  • FIG. 1C is a cross-sectional view of the adjustable shunting system of FIG. 1A.
  • FIG. 2 is a partially schematic illustration of select portions of the adjustable shunting system of FIGS. 1A-1C.
  • FIG. 3 is another partially schematic illustration of select portions of the adjustable shunting system of FIGS. 1A-1C.
  • FIG. 4 is another partially schematic illustration of select portions of the adjustable shunting system of FIGS. 1A-1C.
  • FIGS. 5 A and 5B illustrate an adjustable shunting system configured in accordance with another embodiment of the present technology.
  • FIGS. 6A-6C illustrate another adjustable shunting system configured in accordance with select embodiments of the present technology.
  • FIGS. 7A-7C illustrate additional features of an actuator assembly of the adjustable shunting system of FIGS. 6A-6C.
  • FIGS. 8A and 8B illustrate another adjustable shunting system configured in accordance with select embodiments of the present technology.
  • FIGS. 9A and 9B illustrate another adjustable shunting system configured in accordance with select embodiments of the present technology.
  • FIG. 10 illustrates a cap assembly configured for use with the adjustable shunting systems of FIGS. 8A-9B and configured in accordance with select embodiments of the present technology.
  • FIG. 11 illustrates a microfluidic channel extending through a plate assembly of the system of FIGS. 9A and 9B and configured in accordance with select embodiments of the present technology.
  • the present technology 7 is generally directed to adjustable shunting systems for controlling fluid flow between a first body region and a second body region.
  • the disclosed shunting systems can include multiple components that can be separately manufactured and coupled together to form each system.
  • the systems can include an actuator assembly, a control assembly, and a fluidics assembly.
  • the systems can utilize manufacturing techniques that enable the systems to be produced with suitable precision and in bulk.
  • the present technology provides an optically actuated, latching or non-latching, fluid microvalve capable of vary ing fluid flow rate and/or fluid resistance through it at any' given input pressure between a low value and a high value.
  • the ratio of the high to low' flow rates and/or resistances can be set by design by varying the dimensions of the appropriate elements (as described in greater detail below) and may be in excess of about 10: 1, or about 8: 1, or about 6: 1.
  • the valve is suitable for use with liquids and gasses, such as to control the flow of fluid through an adjustable shunting system.
  • the microvalve design is suitable for scaling to ⁇ mm X ⁇ few mm X ⁇ 10s mm in overall dimensions.
  • the shunting systems and/or microvalves described herein are suitable for being manufactured in parallel at the wafer and/or die assembly scale using a combination of various MEMS fabrication processes and techniques with combinations of selected materials.
  • the design is compatible with material and process choices for the microvalve to be biocompatible and suitable for long-term implantation in human subjects/animals when used in conjunction with an appropriate housing.
  • the systems described herein can be designed for shunting fluid between a variety of body regions.
  • many of the embodiments described herein are designed to be implanted in a patient’s eye to shunt aqueous between the anterior chamber and a target outflowlocation (e.g., a subconjunctival bleb space), such as to treat glaucoma.
  • a target outflowlocation e.g., a subconjunctival bleb space
  • the present technology 7 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, different body region of a patient.
  • 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.
  • the systems described herein can be used to treat diseases characterized by increased pressure and/or fluid buildup, 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-1C illustrate an adjustable shunting system 100 (‘‘the system 100"’) configured in accordance with select embodiments of the present technology. More specifically, FIG. 1 A is a perspective view of the system 100, FIG. IB is an exploded view of the system 1 0, and FIG. 1C is a cross-sectional view of the system 100 taken along the line 1C-1C indicated in FIG. 1 A. As described in greater detail below, the system 100 is configured to provide a titratable therapy for shunting fluid from a first body region to a second body region, such as shunting aqueous from an anterior chamber of a patient’s eye to a target outflow location.
  • a titratable therapy for shunting fluid from a first body region to a second body region, such as shunting aqueous from an anterior chamber of a patient’s eye to a target outflow location.
  • the system 100 includes at least three distinct components that can be separately manufactured and assembled to form the system 100: (a) an actuator component or assembly 110, (b) a control component or assembly 120, and (c) a fluidics component or assembly 130.
  • the actuator assembly 110 can include a cover or lid 111 having a top surface 112 and a plurality of side surfaces 113.
  • the cover 1 11 can be composed of glass, silicon, or another generally rigid material.
  • the actuator assembly 110 can further include a trim layer, flange, or perimeter 114 extending around an interior perimeter of the side surfaces 113 of the cover 111.
  • An actuator 116 can extend across the actuator assembly 110 from a first portion of the trim layer 114 to a second, opposite portion of the trim layer 114.
  • the trim layer 114 and the actuator 116 comprise a unitary component (e.g., manufactured using additive or subtractive manufacturing techniques as single component).
  • the trim layer 114 and the actuator 116 are at least partially composed of a shape memory material, such as Nitinol or Nitinol-containing materials.
  • the Nitinol has a transition temperature between a first material state (e.g., martensitic, R-state, etc.) and a second material state (e.g., R-state, austenitic) greater than body temperature.
  • the shape memory properties of the actuator 116 can be utilized to drive actuation of the system 100, as described below'.
  • the actuator assembly 110 also can include a cavity or recess 118 facing away from the top surface 112 (e.g.. facing downward in the illustrated configuration).
  • the control assembly 120 includes a frame 122 and a flow control element 124.
  • the frame 122 is configured to fit at least partially within the cavity 118 of the actuator assembly 110.
  • the flow' control element 124 is configured to be controlled by the actuator 116 to control fluid flow' through the system 100, as described below.
  • the control assembly 120 includes one or more support elements 126 (shown as a T-shaped beam although other configurations are possible) configured to support the flow control element 124 and/or provide a pivot point for the flow control element 124.
  • the control assembly 120 can be composed of silicon or another suitable material.
  • the fluidics assembly 130 defines a lumen or channel 132 for transporting fluid between a first body region and a second body region of a patient when the system 100 is implanted in the patient.
  • the lumen 132 includes an inlet 133, an outlet 134, and allow restrictor portion 136.
  • the fluidics assembly 130 also includes a thinned portion or diaphragm 138 covering the flow restrictor portion 136. As described below, the diaphragm 138 is at least partially deflectable/deformable into the flow restrictor portion 136 to selectively control fluid resistance through the lumen 132.
  • the fluidics assembly 130, including the diaphragm 138 is composed of glass, silicon, silicone, or other suitable materials.
  • the actuator assembly 110 In an assembled configuration (e.g., shown in FIG. 1A), the actuator assembly 110, the control assembly 120. and the fluidics assembly 130 are vertically stacked and coupled together (e.g., chemically bonded, glued, etc.). As set forth above, the control assembly 120 sits at least partially within the cavity 118 defined by the actuator assembly 110. The inherent interference betw een the control assembly 120 and the actuator 116 (when assembled together as shown in FIG. 1A) therefore induces an upward bow or otherwise deforms/deflects the actuator 116 upw ardly toward the top surface 112 of the actuator assembly 110. This deflection induces strain in the actuator 116, priming it for actuation, as described below.
  • the flow control element 124 is positioned between the actuator 116 and the diaphragm 138.
  • the flow- control element 124 is coupled/affixed to the actuator 116.
  • the actuator 116 sits within a sealed chamber 140 (FIG. 1C) between an upper surface of the fluidics assembly 130 and a lower surface of the actuator assembly 110.
  • an inert gas e.g., argon
  • filling the sealed chamber 140 with argon or another inert gas may obviate issues associated with preloading the diaphragm 138 via the pressure differential associated with the vacuum. It is further expected that filling the sealed chamber 140 with argon or another inert gas (or having the sealed chamber 140 under vacuum) may improve the heat transfer properties associated with the actuator 116 as compared with having the features of the system 100 in an aqueous environment (such as in the patient’s eye).
  • fluid flows through the lumen 132 between the inlet 133 and the outlet 134 (labeled as a ‘'fluidics path” in FIG. 1C).
  • the fluid passes through the flow restrictor portion 136, which includes flowing up and over a projection or extension 137, which in the illustrated embodiment includes a raised annular lip.
  • a user can selectively control the flow of fluid through the lumen 132 generally, and the flow restrictor portion 136 specifically, by actuating the actuator 116.
  • actuating e.g., heating above a transition temperature
  • a first portion 116a of the actuator 116 causes the first portion 116a of the actuator 116 to contract, which pivots the flow control element 124 in a clockwise direction relative to the view shown in FIG.
  • actuating the first portion 116a of the actuator 116 pushes the diaphragm 138 downward to an extent that the diaphragm 138 forms a substantial or even complete seal with the projection 137, effectively stopping fluid from flowing through the lumen 132.
  • the operation can be reversed by actuating (e.g., heating above a transition temperature) a second portion 116b of the actuator 116, w hich causes the second portion 116b to contract, thereby pivoting the flow control element 124 in a counterclockwise direction relative to the view shown in FIG. 1C toward a second (e.g., open) position.
  • the flow control element 124 disengages from (or at least ceases to press downwardly on) the diaphragm 138. This increases a dimension of the flow restrictor portion 136 through which fluid can pass, thus decreasing a fluid resistance through the flow restrictor portion 136.
  • the flow control element 124 can therefore be selectively and repeatedly transitioned between at least two different positions (e.g., the first position and the second position) that impart a different fluid resistance through the flow restrictor portion 136 and therefore, for a given pressure differential, a different flow rate through the lumen 132.
  • FIG. 2 illustrates a portion of the system 100 including one of the side surfaces 113 of the actuator assembly 110 (FIG. IB), the actuator 116, the flow control element 124, one of the support elements 126, and the diaphragm 138, with other aspects of the system 100 omitted for purposes of clarity. More specifically, FIG. 2 illustrates a displacement/deformation (in microns) of each of the foregoing components when the flow control element 124 is in the first (e.g., closed) position. As shown, the flow- control element 124 and the diaphragm 138 are each displaced when the flow control element 124 occupies the first (e.g., closed) position. [0033] FIG.
  • FIG. 3 illustrates the actuator 116, the control assembly 120, and the diaphragm 138, with other aspects of the system 100 omitted for purposes of clarity. More specifically, FIG. 3 illustrates a displacement/deformation (in microns) of each of the foregoing components when the flow control element 124 is in the first (e.g., closed) position. As shown, the actuator 116 is deformed by virtue of the control assembly 120 pushing upwardly on the actuator 116 during assembly of the system 100, described previously.
  • FIG. 4 also illustrates the actuator 116, the control assembly 120, and the diaphragm 138, with other aspects of the system 100 omitted for purposes of clarity’.
  • FIG. 4 illustrates strain induced in the actuator 116 following actuation of the first portion 116a of the actuator 116 (e.g., to drive the flow control element 124 toward the first position). As shown, there is more strain in the second portion 116b than the first portion 116a following actuation of the first portion 116a. This is because actuating the first portion 116a causes the first portion 116a to transition to a different material state (e.g., austenitic) and toward a default/shape memory (e.g., manufactured, shape-set, etc.) geometry.
  • a different material state e.g., austenitic
  • a default/shape memory e.g., manufactured, shape-set, etc.
  • FIGS. 5 A and 5B illustrate a portion of an adjustable shunting system (“the system 200”) configured in accordance with another embodiment of the present technology. More specifically, FIG. 5 A is a perspective view of a fluidics component or assembly 230 of the system 200 and FIG. 5B is a top view of the fluidics assembly 230.
  • the illustrated fluidics assembly 230 includes a number of features identical or generally similar to certain features of the system 100 described above with reference to FIGS. 1A-1C.
  • the fluidics assembly 230 is configured to be assembled with an actuator component or assembly (e.g., the actuator assembly 110 — FIG. IB) and a control component or assembly (e.g., the control assembly 120 — FIG.
  • the fluidics assembly 230 includes a lumen or channel 232 for transporting fluid between a first body region and a second body region of a patient when the assembled system 200 is implanted in the patient.
  • the lumen 232 has an inlet 233 at a first side of the fluidics assembly 230 and an outlet 234 at a second, opposite side of the fluidics assembly 230.
  • the lumen 232 differs from the lumen 132 of the fluidics assembly 130 described above with reference to FIGS.
  • a portion of the lumen 232 has a serpentine arrangement (rather than a generally straight/linear arrangement like the lumen 132).
  • the lumen 232 accordingly has a greater length and a higher resistance (e.g., a fluid or flow resistance) than the lumen 132.
  • the fluidics assembly 230 further includes a flow restrictor portion 236 (FIG. 5B) along the lumen 232 between the inlet 233 and the outlet 234.
  • the fluidics assembly 230 also includes a thinned portion or diaphragm 238 covering the flow restrictor portion 236.
  • the diaphragm 238 is at least partially deflectable/deformable into the flow restrictor portion 236 to selectively control fluid resistance through the lumen 232.
  • the fluidics assembly 230, including the diaphragm 238, may be composed of glass, silicon, silicone, or other suitable materials.
  • FIGS. 6A-6C illustrate a portion of an adjustable shunting system (“the system 600”) configured in accordance with another embodiment of the present technology. More specifically, FIG. 6A is an exploded view of the system 600, FIG. 6B is atop view of the system 600, and FIG. 6C is a cross-sectional view of the system 600 taken along the line 6C-6C shown in FIG. 6B.
  • the system 600 can be composed of a plurality of discrete pieces, components, or layers that can be separately manufactured and then coupled together to form the system 600.
  • the system 600 includes an actuator component or assembly 610, a first control component or assembly 620, a second control component or assembly 640, and a fluidics component or assembly 630.
  • the system 600 can further include a first spacer 650, a second spacer 660, and a cover or lid 670.
  • the various components can be stacked and coupled (e.g., adhered) together to form an assembled configuration, such as the configurations shown in FIGS. 6B and 6C.
  • the actuator assembly 610 can include a first actuator 616a and a second actuator 616b. Similar to the actuator 116 described with respect to FIGS. 1A-4, the first actuator 616a and the second actuator 616b can be composed of a shape memory material (e.g., Nitinol) having a phase transformation temperature greater than body temperature. However, relative to the actuator 116 of the system 100, the first actuator 616a and the second actuator 616b can have a relatively thin and circular or disc-like shape such that the first actuator 61 a and the second actuator 616b form a diaphragm-like element.
  • a shape memory material e.g., Nitinol
  • the first actuator 616a and/or the second actuator 616b can have other suitable shapes in which its width and length are about the same, e.g.. rectangular (e.g., square) shaped, pentagonal shaped, hexagonal shaped, etc.
  • the first actuator 616a and the second actuator 616b can be selectively actuated (e g., heated) to change one or more flow characteristics (e.g., fluid resistance) through the system 600.
  • a first actuator standoff or pin 617a can extend downw ardly from the first actuator 616a and a second actuator standoff or pin 617b can extend downwardly from the second actuator 616b.
  • first actuator pin 617a and the second actuator pin 617b are configured to transfer motion of the first actuator 616a and the second actuator 616b, respectively, to the first control assembly 620 to change one or more fluid characteristics (e.g., fluid resistance, flow rate, etc.) of the system 600.
  • fluid characteristics e.g., fluid resistance, flow rate, etc.
  • the first control assembly 620 can be generally similar to the control assembly 120 described with reference to FIGS. 1 A-4.
  • the first control assembly 620 can include a frame 622 and a movable control element 624 (e.g., an arm, a pendulum, a level, etc.).
  • the movable control element 624 can extend between a first end portion 624a and a second end portion 624b.
  • the first end portion 624a of the movable control element 624 is configured to align with the first actuator pin 617a of the actuator assembly 610
  • the second end portion 624b of the movable control element 624 is configured to align with the second actuator pin 617b of the actuator assembly 610.
  • the first control assembly 620 can further include a support structure 626 extending between parallel walls of the frame 622 to provide support to the movable control element 624.
  • the first control assembly 620 can be composed of silicon, glass, Nitinol, or other suitable materials.
  • the second control assembly 640 can include a frame 642 and a support structure 644 extending between parallel walls of the frame 642.
  • an underside of the movable control element 624 can rest on or sit at least partially within a groove or notch in the support structure 644.
  • the support structure 644 supports a central portion 624c of the movable control element 624 between the first end portion 624a and the second end portion 624b, and can therefore act as a fulcrum for rotation of the movable control element 624, described in greater detail below. Referring to FIGS.
  • the second control assembly 640 further includes a first flow control diaphragm 648a and a second flow control diaphragm 648b.
  • a first standoff or connecting element 646a extends upward from the first flow control diaphragm 648a toward an underside of the movable control element 624, and a second standoff or connecting element 646b extends upward from the second flow control diaphragm 648b toward an underside of the movable control element 624.
  • the first connecting element 646a is configured to transfer motion from the movable control element 624 to the first flow control diaphragm 648a
  • the second connecting element 646b is configured to transfer motion from the movable control element 624 to the second flow control diaphragm 648b.
  • the second control assembly 640 can also be composed of silicon, silicone, glass, Nitinol. or other suitable materials.
  • the actuator assembly 610, the first control assembly 620, and the second control assembly 640 define a chamber 680 (e.g., a hermetically sealed chamber).
  • the movable control element 624 can be configured to rotate within the chamber 680 in response to actuation of the first actuator 616a and/or the second actuator 616b.
  • the chamber 680 can be a vacuum or can be filled with a gas such as. in some embodiments, an inert gas (e.g., argon) which, as described previously, is expected to improve certain operational properties of the systems relying upon shape memory actuation.
  • the first flow control diaphragm 648a and the second flow control diaphragm 648b of the second control assembly 640 sit over a first flow restrictor portion 636a and a second flow restrictor portion 636b, respectively, of the fluidics assembly 630.
  • the first flow restrictor portion 636a and/or the second flow restrictor portion 636b can be generally similar to the flow restrictor portion 136 of the system 100 (FIGS. 1 A-1C).
  • first flow restrictor portion 636a and the second flow restrictor portion 636b can each include a raised annular lip extending upward toward an underside of the respective flow control diaphragm, with a fluid path extending through the annular lip.
  • movement of the first flow control diaphragm 648a and/or the second flow control diaphragm 648b can change a flow characteristic (e.g., a fluid resistance) through the fluidics assembly 630, similar to the description above with reference to FIGS. 1A-4.
  • the first flow restrictor portion 636a and the second flow restrictor portion 636b form part of a common fluid pathway through the system 600.
  • the first flow restrictor portion 636a and the second flow restrictor portion 636b form different fluid pathways through the system 600.
  • the fluidics assembly 630 can be composed of silicon, silicone, glass, Nitinol, or other suitable materials.
  • the first spacer 650 is configured to sit at least partially between the actuator assembly 610 and the cover 670. and includes (a) a first actuator aperture 656a for receiving, and accommodating movement of, the first actuator 616a, and (b) a second actuator aperture 656b for receiving, and accommodating movement of, the second actuator 616b.
  • the empty space defined by the first actuator aperture 656a and/or the second actuator aperture 656b can be a hermetically sealed chamber (by virtue of the cover 670 being hermetically sealed to the first spacer 650, which can be hermetically sealed to the actuator assembly 610).
  • the empty' space of the first actuator aperture 656a and/or the second actuator aperture 656b can be a vacuum or filled with an inert gas such as argon.
  • the second spacer 660 is configured to sit at least partially between the second control assembly 640 and the fluidics assembly 630, and includes (a) a first diaphragm aperture 668a for receiving, and accommodating movement of, the first flow control diaphragm 648a, and (b) a second diaphragm aperture 668b for receiving, and accommodating movement of, the second flow control diaphragm 648b.
  • the first spacer 650 and the second spacer 660 can be composed of silicon, glass, Nitinol, or other suitable materials.
  • the cover 670 can be composed of glass or other transparent material that permits the first actuator 616a and the second actuator 616b to be selectively actuated (e.g., via laser actuation as described throughout).
  • the system 600 enables a user to selectively change a flow characteristic (e.g., fluid resistance) through the fluidics assembly 630 by virtue of changing the degree of deflection of the first flow control diaphragm 648a and/or the second flow' control diaphragm 648b.
  • a flow characteristic e.g., fluid resistance
  • the first flow control diaphragm 648a can be movable between at least a first (e.g., closed) position in w'hich it restricts, plugs, or even seals fluid from flowing through the first flow restrictor portion 636a of the fluidics assembly 630, and a second (e.g., open) position in which it permits more flow' through the first flow restrictor portion 636a.
  • the second flow control diaphragm 648b can similarly be movable between first and second positions providing different fluid resistances through the second flow restrictor portion 636b.
  • FIG. 6C illustrates the first flow control diaphragm 648a in the first (e.g., closed) position and the second flow' control diaphragm 648b in the second (e.g., open) position.
  • fluid may be blocked from flowing through the first flow restrictor portion 636a but may be permitted to flow through the second flow restrictor portion 636b.
  • the first flow control diaphragm 648a and the second flow control diaphragm 648b can be moved (e.g., between at least the first and second positions) via actuation of the first actuator 616a and the second actuator 616b, respectively, and corresponding motion of the movable control element 624.
  • FIG. 7A illustrates the actuator assembly 610 in a pre-assembled configuration before it has been loaded into the system 600, with other aspects of the system 600 omitted for purposes of illustration.
  • the first actuator 616a and the second actuator 616b are relatively flat (the term “relatively flat” may have different meanings depending on the application — in some cases, the term “relatively flat” refers to a component lying within the same general plane or layer; in other cases, the term “relatively flat” refers to the respective components being significantly wider than they are tall, or vice versa).
  • FIG. 7B illustrates the actuator assembly 610 after it has been loaded into the system 600 but before it has been actuated.
  • loading the actuator assembly 610 deforms (e.g., pre-strains) both the first actuator 616a and the second actuator 616b, causing them both to flex, bow, tent, or otherwise deform upwardly (e.g., into the corresponding first actuator aperture 656a and the second actuator aperture 656b shown in FIG. 6A).
  • the first actuator pin 617a and the second actuator pin 617b engage the movable control element 624, which applies a generally similar upward force on both the first actuator pin 617a and the second actuator pin 617b.
  • FIG. 7C illustrates the actuator assembly 610 after the first actuator 616a has been actuated (e.g., heated above a transition temperature to transform from a first matenal state having relatively less stiff mechanical properties to a second material state having relatively stiffer mechanical properties).
  • actuating the first actuator 616a causes the first actuator 616a to move toward its default geometry, which as set forth above is generally flat within a single plane (FIG. 7A).
  • the first actuator pin 617a moves downwardly and applies a greater dow nward force on the first end portion 624a of the movable control element 624 (FIGS.
  • a ratio between the downward forces applied by the first actuator pin 617a and the second actuator pin 617b is greater than about 1.5: 1, greater than about 2: 1, greater than about 3: 1, greater than about 4: 1, greater than about 10: 1, and/or greater than about 20: 1.
  • the imbalance between the downw ard forces on either end of the movable control element 624 rotates the movable control element 624 in a counterclockwise direction and pushes the first flow control diaphragm 648a (FIGS.
  • the first flow control diaphragm 648a can seal or substantially seal the first flow 7 restrictor portion 636a and prevent or substantially prevent fluid from flowing therethrough. Because the movable control element 624 rotates about its central portion 624c. the second end portion 624b rotates upwardly as the first end portion 624a rotates downwardly. This further deforms the second actuator 616b relative to its default geometry (which remains in the first material state having relatively less stiff mechanical properties) by pushing the second actuator pin 617b upwardly, or otherwise permitting the second actuator pin 617b to deflect upwardly.
  • the operation can be reversed by actuating the second actuator 616b, which causes clockwise rotation of the movable control element 624 and pushes the second flow 7 control diaphragm 648b into the second flow restrictor portion 636b. Accordingly, the actuator assembly 610 can be repeatedly and selectively actuated to change one or more fluid characteristics through the fluidics assembly 630.
  • FIG. 8A illustrates another adjustable shunting system 800 (‘‘the system 800”) configured in accordance with select embodiments of the present technology.
  • the system 800 can include an actuator 810, a control or microvalve assembly 820, and a fluidics assembly or plate 830.
  • Flow is regulated in the system 800 by selectively moving a control element 824 (which in the illustrated embodiment is a flat paddle plate and is integrally formed w ith the body of the control assembly 820) placed in proximity to the fluidics assembly 830.
  • a lower surface of the control element 824 is spaced apart from an upper surface of the fluidics assembly 830 by between about 0.1 and aboutl .O micron.
  • the lower surface of the control element 824 may slidably engage an upper surface of the fluidics assembly 830.
  • the control element 824 is positioned generally adjacent a hole or aperture 832 in the fluidics assembly 830.
  • the hole 832 has a diameter of between about 5 microns and about 50 microns, or a diameter that is at least smaller than a surface area of a lower surface of the control element 824 so that the control element 824 variably obscures the hole 832 over its range of motion, as described below.
  • the fluidics assembly 830 can itself have one or more microfluidic channels extending at least partially therethrough and configured to route fluid to and/or from the hole 832.
  • the ratio of the various fluid resistances through the hole 832 that can be obtained by selectively manipulating a position of the control element 824 is determined in part by the diameter of the hole 832, the diameter of the control element 824, the fraction of the hole 832 that can be obscured in various positions of the control element 824, the vertical spacing between the control element 824 and the hole 832, and the configuration of the system 800 components itself (e.g., the configuration of mechanical suspension beams 826 and the actuator 810).
  • the control assembly 820 further includes a plurality of mechanical suspension or support beams or members 826 that are arranged in a cantilevered or clamped manner and integrated with a frame 822 of the control assembly 820.
  • the mechanical suspension beams 826 can ensure that the control element 824 maintains a desired vertical spacing from the upper surface of the fluidics assembly 830 over the entire range of motion of the control element 824.
  • single or multiple mechanical suspension beams 826 may be used to control stiffness in different directions and guide motion of the control element 824 to the desired path and positions.
  • the mechanical suspension beams 826 are designed to provide a relatively large vertical stiffness to lateral stiffness ratio so that the control element 824 may move substantially parallel to the upper surface of the fluidics assembly 830 while avoiding contact therewith.
  • the control element 824 can be selectively transitioned between two or more positions providing two or more different fluid resistances through the hole 832 via actuation of the actuator 810.
  • the actuator 810 can comprise a shape memory material (e.g., Nitinol) having a material phase transformation temperature greater than body temperature such that shape memory properties can be used to induce movement in the actuator 810, and thus induce movement of the control element 824.
  • the actuator 810 can include pre-strained patterned films or wires of Nitinol that are coupled to the control assembly 820.
  • the actuator 810 can be heated (and thus actuated) using an external laser or other optical energy source that is focused on a portion of the actuator 810. Selective heating of portions of the Nitinol actuator, that is appropriately designed, with the external focused laser enables controlling the directivity of the force/torque and therefore the direction of actuation.
  • the Nitinol composition may be optionally selected to exhibit superelastic behavior at the operating temperature to achieve different behaviors.
  • the use of operation-temperature superelastic Nitinol films to actuate the actuator 810 can enable latching or non-latching switching behavior between two or more positions depending on the design and arrangement of the mechanical suspension beams 826 and the composition and behavior of the actuator 810.
  • a bistable, double-clamped curved beam suspension such as the mechanical suspension beams 826 show n in FIG. 8A
  • w ould enable latching behavior with potential positions of the control element 824 determined by the suspension design.
  • a monostable double-clamped suspension or a cantilevered suspension in conjunction with an operation-temperature superelastic Nitinol actuator would enable nonlatching valve behavior.
  • the use of a shape memory' alloy composition Nitinol actuator element will enable a latching behavior with a monostable simple double-clamped suspension or a cantilevered suspension with the control element positions determined largely by the hysteresis behavior of the Nitinol actuator.
  • the system 800 can be fabricated in a combination of borosilicate glass and silicon.
  • the fluidics assembly 830 can be made of glass and the control assembly 820 (e.g., the frame 822, the control element 824, and the mechanical suspension beams 826) can be made of silicon.
  • the glass fluidics assembly 830 contains the hole 832, which can be wet/dry etched, laser drilled, or formed by molding the glass wafer using a silicon template wafer and a bonding, reflow, polishing wafer process.
  • the silicon control assembly 820 can be formed using, e.g., a (Bosch) Deep Reactive Ion Etching process in a single crystal silicon wafer using an appropriate mask.
  • this technique is expected to enable the production of a high aspect ratio mechanical suspension beam 826 with a high vertical stiffness to lateral stiffness ratio that is desirable for operation of the control assembly 820, as described above.
  • one or more cavities of varying target depths can be etched into the surface of the silicon forming the underside of the control assembly 820 that will contact the glass of the fluidics assembly 830 to avoid contact over these portions and allow the control element 824 to move freely parallel to the hole 832 and maintain the desired spacing of the control element 824 to the upper surface of the fluidics assembly 830 for the designed on/off flow ratio.
  • these gaps/cavities forming a spacing between portions of the control assembly 820 and the fluidics assembly 830 may be patterned and/or etched into the surface of the glass (e.g., into the upper surface of the fluidics assembly 830).
  • the silicon can be coated with a thin, thermally grown oxide layer to promote biocompatibility.
  • the silicon wafer e.g., the control assembly 820
  • the glass wafer e.g., the fluidics assembly 830
  • the fluidics assembly 830 can feature a patterned thin metal film, preferably of the same Nitinol or other shape memory material as the actuator 810, to allow selective optical transparency over portions of the fluidics assembly 830. Both the inner and outer sides of the fluidics assembly 830 may incorporate such patterned films.
  • the actuator 810 which as set forth above can be composed of Nitinol or another suitable shape memory material, can be deposited and patterned on a separate wafer and released from it, resulting in freestanding patterned foil. Integration of the actuator 810 into the control assembly 820 can be accomplished at the wafer or die level using pick and place microassembly tools.
  • the actuator 810 can be attached (e.g., permanently 7 attached) to the control assembly 820 by dispensing adhesive droplets ( ⁇ few' 10s um diameter) at targeted bonding locations.
  • FIG. 9A illustrates another adjustable shunting system 900 (“the system 900”) configured in accordance with select embodiments of the present technology.
  • the system 900 can be generally similar to the system 800 described with reference to FIGS. 8A and 8B.
  • the system 900 can include a fluidics assembly or plate 930 having a hole or aperture 932 extending therethrough (FIG. 9B).
  • the system 900 further includes a control assembly 920 having a frame 922, a control element 924, and a mechanical suspension beam 926.
  • the system 900 includes a single mechanical suspension beam 926 that does not extend between opposite and parallel sides of the frame 922.
  • the system 900 also includes an actuator 910, which can be a shape memory actuator having a material phase transformation temperature that is greater than bodytemperature such that its shape memory properties can be used to induce motion in the actuator 910, and thus the control assembly 920, similar to the description above.
  • the actuator 910 can be secured to the control assembly 920 using adhesive droplets at target bonding locations, w hich are marked with an "X " in FIG. 9A.
  • the system 900 can be manufactured using similar techniques as described above with reference to the system 800 of FIGS. 8A and 8B.
  • FIG. 10 illustrates a cap 1000 that is configured in accordance with select embodiments of the present technology 7 and that can be used in connection with either the system 800 or the system 900. More specifically, FIG. 10 is a cross- sectional view of the cap 1000 extending over the system 900. Although shown with the system 900, the cap 1000 can equally be used with the system 800, as one skilled in the art will appreciate.
  • the cap 1000 can be used to close off the top face of the system 800 or the system 900.
  • the cap 1000 includes a fluid transfer hole 1002 for permitting fluid to flow through the cap 1000.
  • the cap 1000 (or alternatively a special tooling wafer) may be designed and fabricated to engage with select portions of the actuator 910 that overhangs the control assembly 920, pushing the portions of the actuator 910 perpendicular to the plane occupied by the control assembly 920, prior to the completion of adhering all the attachment points of the actuator 910 to the control assembly 920.
  • only one portion of the actuator 910 is locked to the control assembly 920 using an adhesive prior to assembly of the cap 1000 over the actuator 910 (marked in FIG. 10 using an “X”).
  • the engagement of the actuator 910 with the cap 1000 or assembly tool wafer during assembly motion may then be used to induce the desired pre-strain (e.g., deformation) to the actuator 910 based on the designed overlap of the cap 1000 and the control assembly 920.
  • the pre-strained actuator 910 can then be locked into the control assembly 920 by completing the application of adhesive to the remaining attachment locations through adhesive application windows 1004 in the cap 1000.
  • the cap 1000 can be fabricated in a glass or silicon wafer using fabrication techniques similar to those described earlier.
  • the fluidics assembly 830 or 930 may further include one or more fluidics channels that connect to the hole in the fluidics assembly and that can be used to provide a designed fluid resistance in series with the system 800 or 900.
  • FIG. 11 illustrates the fluidics assembly 930 of FIGS. 9A and 9B with a fluidics channel 1138 extending at least partially therethrough.
  • a housing (not shown) for the system 900 can form the base that will result in enclosed flow channels.
  • the silicon/glass wafer combination described in the previous process may be replaced with a titanium wafer/expansion matched glass combination, but with the titanium patterned using a DRIE process which is similar to that used to pattern silicon but is chlorine based.
  • the systems described herein can be designed for shunting fluid between a variety of body regions, either alone or in combination with additional components.
  • the systems described herein are designed to be implanted in a patient's eye to shunt aqueous between the anterior chamber and a target outflow location (e.g., a subconjunctival bleb space), such as to treat glaucoma.
  • a target outflow location e.g., a subconjunctival bleb space
  • the systems described herein can have dimensions compatible with being implanted in the patient’s eye.
  • adjustable shunts incorporating the systems/microvalves described herein may have a length of between about 4 mm and about 20 mm, such as between about 4 mm and 15 mm, or between about 4 mm and 12 mm, or between about 6 mm and 10 mm, or about 8 mm.
  • individual components e.g., layers
  • the diameter of the fluidic channels and corresponding apertures e.g..
  • channel 132; channel 232; channel 1138) may be less than about 100 microns, less than about 75 microns, and/or less than about 50 microns, such as about 35 microns.
  • the foregoing dimensions are provided by way of example only, and other dimensions outside the ranges provided above are possible and included within the scope of the present technology. Indeed, the dimensions of the systems described herein may be designed depending on the type of shunting system (e.g., glaucoma shunt vs. hydrocephalus shunt) and intended recipient (e.g., child vs. adult).
  • one expected advantage of the system 100 is that select components can be manufactured with precision and in large quantities despite the relatively small sizes of these components.
  • the actuator assembly 110 and/or the control assembly 120 can be manufactured as glass and/or silicon wafers before being coupled together to form the system 100. This is expected to increase the efficiency and reproducibility of manufacturing the system 100. Examples
  • An adjustable shunting system for shunting fluid from a first body region to a second body region within a patient, the adjustable shunting system comprising: an actuator assembly including a shape memory' actuator; a control assembly including a flow control element; and a fluidics assembly including a lumen having a flow restrictor portion and a diaphragm extending over the flow restrictor portion, wherein the actuator assembly, the control assembly, and the fluidics assembly are vertically stacked such that the shape memory actuator is positioned within a chamber above the flow control element and the flow control element is positioned above the diaphragm, and wherein the shape memory actuator is configured to selectively transition the flow control element between at least two positions, and wherein in a first position of the at least two positions, the flow control element deflects the diaphragm into the flow restrictor portion to increase a fluid resistance therethrough.
  • control assembly is composed at least partially of silicon.
  • An adjustable shunting system for shunting fluid from a first body region to a second body region within a patient, the adjustable shunting system comprising: an actuator assembly including a shape memory actuator; a first control assembly including a flow control element, wherein the flow control element is movably coupled to the shape memory actuator; and a second control assembly including a flow control diaphragm, wherein the flow control diaphragm is movably coupled to the flow control element, wherein, in response to being actuated, the shape memory 7 actuator is configured to rotate the flow control element to change a position of the flow control diaphragm.
  • the shape memory actuator is a first shape memory actuator and the flow control diaphragm is a first flow control diaphragm, and wherein the system further comprises: a second shape memory actuator, wherein the second shape memory actuator is movably coupled to the flow control element; and a second flow control diaphragm, wherein the second flow control diaphragm is movably coupled to the flow control element.
  • a microfluidic valve assembly for use with an adjustable shunting system, the microfluidic valve assembly comprising: a shape memory actuator; a control assembly having a movable control element and one or more mechanical suspension members; and a plate having a hole extending at least partially therethrough, wherein the shape memory actuator is configured to move the movable control element relative to the hole via deflection of the one or more mechanical suspension members.
  • control assembly has a first surface area
  • hole has a second surface area less than the first surface area such that the control assembly variably obscures the hole as the control element moves over its range of motion.
  • control assembly comprises a plurality of mechanical support members arranged in a cantilevered configuration, and wherein the plurality of mechanical support members are sized and shaped to position the control assembly at a desired vertical spacing from the plate.
  • 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 portion(s) of this application.

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  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Veterinary Medicine (AREA)
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  • Animal Behavior & Ethology (AREA)
  • Vascular Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Fluid-Pressure Circuits (AREA)

Abstract

La présente technologie concerne de manière générale des systèmes de dérivation réglables pour commander un écoulement de fluide entre une première région de corps et une seconde région de corps. Les systèmes de dérivation peuvent comprendre de multiples composants qui peuvent être fabriqués séparément et couplés entre eux pour former chaque système individuel. Par exemple, les systèmes peuvent comprendre un ensemble actionneur, un ensemble de commande et un ensemble fluidique.
PCT/US2023/080290 2022-11-18 2023-11-17 Systèmes de dérivation réglables et leurs procédés de fabrication WO2024108125A2 (fr)

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WO2008061043A2 (fr) * 2006-11-10 2008-05-22 Glaukos Corporation Dérivation uvéosclérale et procédés pour son implantation
AU2015243960B2 (en) * 2014-04-07 2019-08-01 Csfrefresh Incorporated Programmable CSF metering shunt
GB201622036D0 (en) * 2016-12-22 2017-02-08 Lenel Ursula And Cambridge Mechatronics Variable valve infusion pump
EP4135640A4 (fr) * 2020-04-16 2024-04-17 Shifamed Holdings, LLC Dispositifs réglables de traitement de glaucome, ainsi que systèmes et méthodes associés

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