WO2025207671A1 - Dispositifs et procédés de réparation de valvule cardiaque - Google Patents

Dispositifs et procédés de réparation de valvule cardiaque

Info

Publication number
WO2025207671A1
WO2025207671A1 PCT/US2025/021396 US2025021396W WO2025207671A1 WO 2025207671 A1 WO2025207671 A1 WO 2025207671A1 US 2025021396 W US2025021396 W US 2025021396W WO 2025207671 A1 WO2025207671 A1 WO 2025207671A1
Authority
WO
WIPO (PCT)
Prior art keywords
anchors
central body
anchor
implementations
arm
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/US2025/021396
Other languages
English (en)
Inventor
Noam NIR
Ofry Efraim YOSSEF
Carmel PELEG
Aviv GALON
Eva Adriana de la Cruz ROMITO
Yaron Herman
Bar EYTAN-VAISMAN
Zachary James ZIRA
Itay AVINATHAN
Gil HAMERMAN
Ido HALABI
Meir ABUCASIS
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Edwards Lifesciences Corp
Original Assignee
Edwards Lifesciences Corp
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 Edwards Lifesciences Corp filed Critical Edwards Lifesciences Corp
Publication of WO2025207671A1 publication Critical patent/WO2025207671A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0033—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit

Definitions

  • a healthy heart has a generally conical shape that tapers to a lower apex.
  • the heart is four-chambered through which blood flows,
  • a native human heart includes four chambers: two atria (upper chambers) - the left atrium and the right atrium, and two ventricles (lower chambers) - the left ventricle and the right ventricle.
  • a wall, the septum separates the right and left sides of the heart (i.e., of each pair of chambers).
  • a respective native valve the mitral, tricuspid, aortic, and pulmonary valves, respectively
  • deoxygenated blood from the body is received in the right atrium and passes downstream (forward) through the tricuspid valve to the right ventricle. From the right ventricle it is pumped downstream through the pulmonary valve to the lungs by way of a blood vessel for blood with low oxygen levels, the pulmonary artery.
  • oxygenated blood from the lungs is received in the left atrium and passes downstream through the mitral valve to the left ventricle. From the left ventricle it is pumped downstream through the aortic valve to the remainder of the body by way of a blood vessel for oxygen rich blood, the aorta.
  • the systolic phase includes an atrial systole, when the atria contract to eject blood from within the atria downstream into their respective ventricles; and ventricular systole, when the ventricles contract to eject blood from within the ventricles downstream into their respective downstream blood vessels.
  • the tricuspid, aortic, and pulmonary heart valves have three leaflets, while the mitral valve has two leaflets (also known as cusps).
  • the leaflets operate as flaps that open and close to allow the downstream (forward) flow of blood when pressure urges the blood forward through the valve and obstructs the flow of blood through the valve when pressure urges the blood to flow upstream (backward) through the valve (as occurs for the mitral and tricuspid valves during ventricular systole).
  • the mitral valve which connects the left atrium to the left ventricle, includes an annulus portion, which is an annular portion of the valve’s tissue surrounding a mitral valve orifice, and a pair of leaflets extending downward from the annulus portion into the left ventricle.
  • the mitral valve annulus portion can form a "D" -shaped, oval, or otherwise out-of-round cross-sectional shape having major and minor axes.
  • An anterior leaflet can be larger than a posterior leaflet, forming a generally "C "-shaped boundary between the abutting sides of the leaflets when they are closed together.
  • the anterior leaflet and the posterior leaflet of the mitral valve function together as a one-way valve to allow blood to flow only from the left atrium to the left ventricle.
  • atrial systole after the left atrium received oxygenated blood from the pulmonary veins during cardiac diastole, the muscles of the left atrium contract and the left ventricle dilates (also referred to as "ventricular diastole” or “diastole"), and the oxygenated blood that is collected in the left atrium flows into the left ventricle.
  • the native heart valves serve critical functions in assuring the forward flow of an adequate supply of blood through the cardiovascular system.
  • these heart valves may be dysfunctional (e.g., damaged, or otherwise malformed), and thus less effective, such as by congenital malformations, inflammatory processes, infectious conditions, disease, and the like.
  • dysfunctionality may result in serious cardiovascular compromise or death.
  • One form of dysfunctionality is valvular regurgitation.
  • Valvular regurgitation involves the valve improperly allowing some blood to flow in the wrong direction through the valve. For example, mitral regurgitation occurs when the mitral valve fails to close properly and blood flows upstream into the left atrium from the left ventricle during ventricle systole. Likewise, tricuspid regurgitation occurs when the tricuspid valve fails to close properly and blood flows upstream into the right atrium from the right ventricle during ventricle systole.
  • FIG. 1 shows a device for repairing leaflets, e.g., an anterior leaflet 20 and a posterior leaflet 22, of a dysfunctional mitral valve MV.
  • a catheter or catheter device 11 is positioned in the left atrium LA above the left ventricle LV.
  • the catheter device is coupled to an implant 13.
  • the implant can be positioned to repair the dysfunctional mitral valve MV.
  • While devices like this provide significant potential for potentially lifesaving repairs, there are still challenges.
  • one challenge is that, when treating a beating heart, the leaflets are in motion (both in shape and location) with the continuing operation of the heart.
  • a repair device must navigate and operate relative to a moving target.
  • one or both leaflets of the dysfunctional valve may be deformed and/or damaged.
  • the leaflets might not regularly move into a position and configuration in which they can be readily treated by the repair device.
  • the two or three target leaflets might have unusually large gaps therebetween, and they might be tethered into an unnaturally open position, such as by changes in the underlying structure (e.g., a dilated ventricle).
  • the device includes an anchor portion.
  • one or more anchors of the anchor portion are moveable between an open position and a closed position.
  • the device can be positioned within a heart valve, using a delivery system comprising catheters.
  • the device can include leaflet anchors for attaching to valve leaflets, and one or more connectors forming decouplable or detachable connections between the anchors and the delivery system.
  • the one or more connectors are severable connectors forming severable connections between the anchors and the delivery system.
  • a set of tethers is actuatable to move the anchors closer and/or into contact after the connectors have decoupled or detached leaving the anchors separated from the delivery system.
  • the device can optionally include a spacer positioned to be compressed by opposing surfaces of the anchors when around the spacer.
  • a system can include a transvascular delivery system including a steering catheter system and/or an implant catheter system.
  • the system can also include a device (e.g., treatment device, repair device, valve repair device, implantable device, implant, valve treatment device, etc.) that is introduced via the implant catheter system.
  • the implant catheter system can optionally be guided by a steering catheter system.
  • the device includes a plurality of anchors (e.g., leaflet anchors, tissue anchors, clips, clasps, toggle anchors, staples, rivets, darts, etc.) that attach to tissue (e.g., one or more leaflets, an annulus, etc.) of a valve.
  • anchors e.g., leaflet anchors, tissue anchors, clips, clasps, toggle anchors, staples, rivets, darts, etc.
  • the plurality of tethers are configured to pull the plurality of anchors toward the central body and to allow the plurality of anchors to be spaced apart from the central body.
  • slack in a tether can allow a corresponding anchor to be spaced apart from the central body.
  • the plurality of tethers are configured to pull the plurality of anchors against the central body, such that at least a portion of an anchor of the plurality of anchors abutted against the central body.
  • the actuator can be operatively coupled to the plurality of anchors when the anchors are pulled against the central body by the tethers. That is, while one or more anchors of the plurality of anchors are abutted against the central body, the anchor can be coupled to the one or more anchors.
  • the anchor can comprise an actuator engagement extension.
  • the paddle of the anchor comprises an actuator engagement extension.
  • the paddle comprises a plurality of actuator engagement extensions.
  • a first actuator engagement extension of the plurality of actuator engagement extensions can be used to open the paddle, while a second actuator engagement extension can be used to close the paddle.
  • the actuator is configured to engage the anchor to move the anchor to a closed position. In some implementations, the actuator is configured to engage the anchor to move the anchor to an open position.
  • the anchor can comprise a plurality of actuator engagement extensions.
  • the actuator can be configured to engage a first one of the plurality of actuator engagement extensions to move the anchor to a closed position and can be further configured to engage a second one of the plurality of actuator engagement extensions to move the anchor to an open position.
  • the tethers are configured to allow the anchors to tilt as the anchors are pulled toward the central body. For instance, by while a tether pulls an anchor toward the central body, the anchor can be permitted to tilt relative to the central body. In some implementations, the anchor can be configured to tilt away from the central body as it is pulled toward the central body.
  • each tether is connected to a closed end of each anchor.
  • a tether can be connected to a closed end of the corresponding anchor.
  • a valve repair system includes a valve repair device and a delivery system.
  • the delivery system can include one or more catheters and a control handle.
  • the valve repair device includes a central body, a plurality of anchors, a plurality of tethers attached to the plurality of anchors, and an actuator.
  • the plurality of anchors can be attached to the central body via the plurality of tethers.
  • the actuator can be coupled to the central body.
  • each anchor can be coupled to the central body via a corresponding tether. In some implementations, each anchor can be coupled to the central body via one or more tethers.
  • the plurality of tethers are configured to pull the plurality of anchors toward the central body and to allow the plurality of anchors to be spaced apart from the central body.
  • slack in a tether can allow a corresponding anchor to be spaced apart from the central body.
  • the plurality of tethers are configured to pull the plurality of anchors against the central body, such that at least a portion of an anchor of the plurality of anchors abutted against the central body.
  • the actuator can be operatively coupled to the plurality of anchors when the anchors are pulled against the central body by the tethers. That is, while one or more anchors of the plurality of anchors are abutted against the central body, the anchor can be coupled to the one or more anchors. [0041] In some implementations, the actuator is configured to open all anchors that are against the central body.
  • the actuator can simultaneously open the one or more anchors that are against the central body.
  • This disclosure includes methods of repairing a heart valve e.g. native heart valve and/or simulated heart valve).
  • methods of repairing a heart valve include opening a plurality of anchors that are against a central body.
  • the plurality of anchors can be simultaneously opened.
  • an implantable device includes an actuator that opens and/or simultaneously opens the plurality of anchors.
  • a first anchor of the plurality of anchors is positioned such that a first native heart valve leaflet is in the first anchor.
  • the implantable device can be moved toward the first native heart valve leaflet such that the open first anchor receives the first native heart valve leaflet.
  • the first anchor is closed to capture the first leaflet.
  • the plurality of anchors that are against the central body e.g. , including but not limited to the first anchor are closed to capture the first leaflet.
  • the central body and a remaining one or more anchors are moved away from the first anchor.
  • the plurality of anchors are coupled to the central body with a plurality of tethers.
  • each tether can couple a corresponding anchor to the central body.
  • the remaining one or more anchors that are against the central body are opened.
  • an actuator can be used to open the remaining one or more anchors that are against the central body.
  • the remaining one or more anchors that are against the central body are simultaneously opened.
  • an actuator can be used to simultaneously open the remaining one or more anchors that are against the central body.
  • a second anchor of the plurality of anchors is positioned such that a second native heart valve leaflet is in the second anchor.
  • the device can be moved toward the second native heart valve leaflet such that the open second anchor receives the second native heart valve leaflet.
  • the plurality of anchors that are against the central body are closed to capture the second leaflet.
  • an actuator can be used to close the plurality of anchors that are against the central body, including the second anchor.
  • the plurality of anchors that are against the central body are simultaneously closed to capture the second leaflet.
  • an actuator can be used to simultaneously close the plurality of anchors that are against the central body, including the second anchor.
  • the present disclosure further includes a vale repair device (e.g. , a heart valve repair device for use in the heart of a real and/or simulated subject).
  • a valve repair device e.g. , a heart valve repair device for use in the heart of a real and/or simulated subject.
  • a valve repair device includes a central body, a plurality of anchors, and a plurality of tethers attached to the plurality of anchors.
  • each anchor can be coupled to the central body via a corresponding tether. In some implementations, each anchor can be coupled to the central body via one or more tethers.
  • the plurality of tethers are configured to pull the plurality of anchors toward the central body.
  • a connection between each tether and each anchor allows the plurality of anchors to tilt as the anchors are pulled toward the central body.
  • the connection between a tether and its corresponding anchor can allow the anchor to assume a tilted position relative to the central body while the anchor is pulled toward the central body.
  • the plurality of anchors and the central body are configured to move the anchors from the tilted position relative to the central body to a more upright position relative to the central body.
  • the anchor can interact with the central body to move from the tilted position to the more upright position.
  • An anchor can be sufficiently close to the central body if at least a portion of the anchor is able to interact with at least a portion of the central body.
  • the retaining wall and the central post are configured to pivot the anchors to a more upright or vertical position.
  • the retaining wall can interact with the anchor to cause the anchor to pivot to the more upright position.
  • the anchors and the central body are configured such that pulling the anchors against the central body pivots the anchors to the more upright position.
  • the central body can interact with the anchor to cause the anchor to pivot to the more upright position.
  • each of the plurality of anchors includes a tilting flange.
  • the tilting flange can interact with a portion of the central body to cause the anchor to tilt.
  • the tilting flange of an anchor can engage the bottom wall to move the anchor to the more upright position.
  • the bottom wall can interact with the anchor to cause the anchor to move to the more upright position.
  • rotation of the central body relative to the anchors moves the anchors to the more upright position.
  • the central body includes a plurality of petals configured to engage the plurality of anchors upon rotation of the central body relative to the plurality of anchors.
  • the plurality of tethers are configured to pull the plurality of anchors toward the central body and to allow the plurality of anchors to be spaced apart from the central body.
  • slack in a tether can allow a corresponding anchor to be spaced apart from the central body.
  • the plurality of tethers are configured to pull the plurality of anchors against the central body, such that at least a portion of an anchor of the plurality of anchors abutted against the central body.
  • a valve repair system includes a valve repair device and a delivery system.
  • the delivery system can include one or more catheters and a control handle.
  • the valve repair device includes a central body, a plurality of anchors, and a plurality of tethers attached to the plurality of anchors.
  • the plurality of anchors can be attached to the central body via the plurality of tethers.
  • each anchor can be coupled to the central body via a corresponding tether. In some implementations, each anchor can be coupled to the central body via one or more tethers.
  • the plurality of tethers are configured to pull the plurality of anchors toward the central body.
  • a connection between a tether and a corresponding anchor allows the plurality of anchors to tilt as the anchors are pulled toward the central body.
  • the connection between a tether and its corresponding anchor can allow the anchor to assume a tilted position relative to the central body while the anchor is pulled toward the central body.
  • the plurality of anchors and the central body are configured to move the anchors from the tilted position relative to the central body to a more upright position relative to the central body.
  • the anchor can interact with the central body to move from the tilted position to the more upright position.
  • An anchor can be sufficiently close to the central body if at least a portion of the anchor is able to interact with at least a portion of the central body.
  • This disclosure provides methods for repairing a heart valve (e.g., a heart valve in a real or simulated subject).
  • the method for repairing a heart valve includes attaching an anchor is to a leaflet of the native heart valve.
  • the anchor is pulled toward a central body in a tilted orientation.
  • the anchor can be attached to the central body via a tether.
  • the anchor can be pulled toward the central body via the tether.
  • the anchor is engaged with the central body to move the anchor from the tilted position relative to the central body to a more upright position relative to the central body.
  • the central body is rotated relative to the anchor to move the anchor to the more upright position.
  • a valve repair device e.g. , a heart valve repair device for repairing a valve in a heart of a real or simulated subject.
  • a valve repair device includes a central body, a plurality of spools disposed in the central body, a plurality of anchors, and a plurality of tethers.
  • the plurality of tethers are attached to the plurality of anchors.
  • a tether can be attached to a corresponding anchor.
  • the plurality of tethers are wound around the plurality of spools.
  • a tether can attach the corresponding anchor to a corresponding spool.
  • rotation of the plurality of spools in a second direction slackens the tethers to allow the plurality of anchors to be spaced apart from the central body.
  • the device includes a plurality of springs bias the plurality of anchors away from the central body.
  • the tethers are configured to allow the anchors to tilt as the anchors are pulled toward the central body.
  • Implementations of the present disclosure provide a valve repair system (e.g. , a heart valve repair system for repairing a valve in a heart of a real or simulated subject).
  • the valve repair system includes a valve repair device and a delivery system.
  • the delivery system can include one or more catheters and a control handle.
  • the valve repair device includes a central body, a plurality of spools disposed in the central body, a plurality of anchors, and a plurality of tethers.
  • the plurality of tethers are attached to the plurality of anchors.
  • a tether can be attached to a corresponding anchor.
  • the plurality of tethers are wound around the plurality of spools.
  • a tether can attach the corresponding anchor to a corresponding spool.
  • a valve repair device includes a center clip and a plurality of anchors.
  • the center clip is configured to capture the plurality of anchors after the plurality of anchors have been attached to leaflets of a native heart valve.
  • the center clip can be configured to maintain the plurality of anchors in a closed position after the plurality of anchors have been attached to leaflets of a native heart valve.
  • a plurality of tethers are attached to the plurality of anchors.
  • a tether can be attached to a corresponding anchor.
  • the corresponding anchor can be attached to the center clip via the tether.
  • the plurality of tethers are configured to pull the plurality of anchors toward the center clip.
  • tethers are configured to allow the anchors to tilt as the anchors are pulled toward the center clip.
  • each tether is connected to a closed end of each anchor.
  • a valve repair system (e.g., a valve repair system for repairing a heart of a real or simulated subject) includes a valve repair device and a delivery system.
  • the delivery system can include one or more catheters and a control handle.
  • the valve repair device includes a center clip and a plurality of anchors.
  • the center clip is configured to capture the plurality of anchors after the plurality of anchors have been attached to leaflets of a native heart valve.
  • the center clip can be configured to maintain the plurality of anchors in a closed position after the plurality of anchors have been attached to leaflets of a native heart valve.
  • this disclosure provides a method of repairing a valve (e.g., a native heart valve of a real or simulated subject.
  • the method includes attaching a plurality of anchors to a plurality of leaflets of the native heart valve.
  • the plurality of anchors are captured with a center clip after the plurality of anchors have been attached to leaflets of the native heart valve.
  • the center clip can be configured to maintain the plurality of anchors in a closed position after the plurality of anchors have been attached to leaflets of a native heart valve.
  • a valve repair device e.g., a valve repair device for repairing a heart of a real or simulated subject
  • a valve repair device includes a central body and a plurality of anchors.
  • the central body has a plurality of expandable strips.
  • the valve repair device includes a plurality of anchors attached to the plurality of expandable strips.
  • an anchor can be attached to a corresponding expandable strip.
  • the plurality of anchors are attached directly to the plurality of expandable strips.
  • the expandable strips are configured to move the plurality of anchors inward and outward.
  • each anchor comprises a paddle and a gripping member attached to the paddle.
  • the paddle comprises a fixed arm and a movable arm.
  • the fixed arm of each paddle is fixed to one of the expandable strips.
  • the gripping member is attached to the movable arm of the paddle.
  • a valve repair system (e.g., a valve repair system for repairing a heart of a real or simulated subject) includes a valve repair device and a delivery system.
  • the delivery system can include one or more catheters and a control handle.
  • the expandable strips are configured to move the plurality of anchors inward and outward.
  • a valve repair device e.g., a valve repair device for repairing a heart of a real or simulated subject
  • a valve repair device includes a central body and a plurality of anchors.
  • each anchor comprises a paddle and a gripping member.
  • the gripping members are movable toward and away from the central body by sliding the gripping members along the paddles.
  • the plurality of anchors comprises three paddles and three gripping members.
  • a valve repair system (e.g., a valve repair system for repairing a heart of a real or simulated subject) includes a valve repair device and a delivery system.
  • the delivery system can include one or more catheters and a control handle.
  • the valve repair device includes a central body and a plurality of anchors.
  • each anchor comprises a paddle and a gripping member.
  • the paddles are connected to the central body.
  • the coupling member is configured to allow the first anchor to move relatively away from the second anchor during diastole.
  • the coupling member is configured to pull the first anchor relatively toward the second anchor during systole.
  • the coupling member comprises one or more of an elastic material and a spring.
  • a valve repair system includes e.g. , a valve repair system for repairing a heart of a real or simulated subject) a valve repair device and a delivery system.
  • the delivery system can include one or more catheters and a control handle.
  • the valve repair device includes a first anchor, a second anchor, and a coupling member attached to the first anchor and the second anchor.
  • the coupling member is configured to allow the first anchor to move relatively away from the second anchor during diastole.
  • the coupling member is configured to pull the first anchor relatively toward the second anchor during systole.
  • a valve repair device e.g., a valve repair device to be used for repairing a heart of a real or simulated subject
  • the valve repair device includes a central body.
  • the central body can include a bore.
  • the paddle can include a first arm that is hingeably attached to a second arm by a hinge portion.
  • the hinge portion comprises an actuation gear.
  • the first arm, second arm, and hinge portion can comprise a gripping member of the paddle.
  • the worm gear is attached to a distal end of the actuation element such that it extends from a bore of the central body.
  • the worm gear can engage one or more actuation gears of one or more anchors that are engaged with the central body.
  • rotating the actuation element and the worm gear in a first direction causes the second arm of the paddle to move and/or pivot in an opening direction via the actuation gear.
  • Moving and/or pivoting the second arm of the paddle in the opening direction can move the anchor, paddle, and/or second arm toward an open condition.
  • the opening direction can be a counterclockwise direction.
  • rotating the actuation element and the worm gear in a second direction causes the second arm of the paddle to move in a closing direction via the actuation gear.
  • Moving and/or pivoting the second arm of the paddle in the closing direction can move the anchor, paddle, and/or second arm toward a closed condition.
  • the closing direction can be a clockwise direction.
  • the valve repair device includes a plurality of tethers attached to the plurality of anchors.
  • one or more tethers can be associated with a corresponding anchor.
  • the plurality of tethers are configured to pull the plurality of anchors against the central body. In some implementations, the plurality of tethers are further configured to allow the plurality of anchors to be spaced apart from the central body, e.g., when there is slack in the tethers. [00150] In some implementations, the paddles or the gripping members of the valve repair device include a locking mechanism that prohibits rotation of the second arm of the paddles when the locking mechanism is in a locked condition.
  • the paddles or the gripping members of the valve repair device include a biasing member arranged between the first arm and the second arm.
  • the biasing member can be configured to bias the second arm in the closing direction, e.g., toward a closed condition.
  • a valve repair device e.g., a valve repair device to be used for repairing a heart of a real or simulated subject
  • the valve repair device includes a central body and a plurality of anchors.
  • each of the anchors includes a gripping member having a first arm, a second arm, and a hinge portion that hingeably connects the first arm to the second arm.
  • the valve repair device includes an actuation element that can extend through a bore of the central body.
  • the actuation element can include one or more of a wire, a rod, a tube, a shaft, a flexible shaft, a suture, a hypotube, etc.
  • the actuation element can include an actuation arm connected to the gripping member.
  • the actuation arm can be connected to the first arm.
  • the actuation arm can be connected to the hinge portion.
  • movement of the actuation element in a proximal direction causes the second arm to pivot in an opening direction. Moving and/or pivoting the second arm of the gripping member in the opening direction can move the anchor, gripping member, and/or second arm toward an open condition.
  • the opening direction can be a counterclockwise direction.
  • movement of the actuation element in a distal direction causes the second arm to pivot in a closing direction.
  • Moving and/or pivoting the second arm of the gripping member in the closing direction can move the anchor, gripping member, and/or second arm toward a closed condition.
  • the closing direction can be a clockwise direction.
  • the valve repair device includes a plurality of paddles.
  • the pivot arm can extend from a paddle of the plurality of paddles, through the second arm, and back to the one of the plurality of paddles.
  • the second arm can include a hinge barrel that the pivot arm passes through.
  • the second arm can include an opening on an outer surface of the gripping member that the pivot arm passes through.
  • the second arm of the gripping member can be biased in the closing direction, e.g., toward a closed condition. In some implementations, the second arm of the gripping member can be biased in the closing direction, e.g., toward a closed condition by the hinge portion of the gripping member.
  • the gripping member can be formed from a shape-set alloy.
  • one or more of the first arm, the second arm, or the hinged portion can be formed from the shape-set alloy.
  • the shape-set alloy is shape-set in the closed condition.
  • the gripping member comprises one or more friction enhancing elements, including, but not limited to barbs, roughened and/or textured surface, an adhesive surface, disposed on the first arm.
  • the valve repair device includes a plurality of tethers attached to the plurality of anchors.
  • one or more tethers can be associated with a corresponding anchor.
  • the plurality of tethers are configured to pull the plurality of anchors against the central body. In some implementations, the plurality of tethers are further configured to allow the plurality of anchors to be spaced apart from the central body, e.g., when there is slack in the tethers.
  • a valve repair device e.g., a valve repair device to be used for repairing a heart of a real or simulated subject
  • the valve repair device includes a central body and a plurality of anchors.
  • an anchor of the plurality of anchors includes a gripping member.
  • the gripping member can have a first arm, a second arm, and a hinge portion that hingeably connects the first arm to the second arm.
  • each anchor includes a gripping member.
  • the valve repair device includes an actuation element.
  • the actuation element extends through a bore of the central body.
  • the actuation element can include one or more of a wire, a rod, a tube, a shaft, a flexible shaft, a suture, a hypotube, etc.
  • the actuation element includes an actuation arm.
  • the actuation arm can be connected to the second arm via a tether connected to an end portion of the actuation arm.
  • the tether can comprise one or more of a wire, a rod, a tube, a shaft, a flexible shaft, a suture, a hypotube, etc.
  • movement of the actuation element in a distal direction causes tension in the tether to cause the second arm to pivot in an opening direction.
  • Moving and/or pivoting the second arm of the gripping member in the opening direction can move the anchor, gripping member, and/or second arm toward an open condition.
  • the opening direction can be a counterclockwise direction.
  • movement of the actuation element in a proximal direction causes the end of the actuation arm to engage the second arm to pivot the second arm in a closing direction.
  • Moving and/or pivoting the second arm of the gripping member in the closing direction can move the anchor, gripping member, and/or second arm toward a closed condition.
  • the closing direction can be a clockwise direction.
  • the actuation arm biases the gripping member in the closing direction, e.g., toward the closed condition.
  • the actuation arm can include a spring portion that biases the end of the actuation arm in the closing direction, e.g., biases the gripping member toward a closed condition.
  • the second arm of the gripping member is biased in the closing direction, e.g., toward a closed condition.
  • the second arm of the gripping member is biased in the closing direction, e.g., toward a closed condition, by the hinge portion.
  • the gripping member can be formed from a shape-set alloy.
  • one or more of the first arm, the second arm, or the hinged portion can be formed from the shape-set alloy.
  • the shape-set alloy is shape-set in the closed condition.
  • the gripping member comprises one or more friction enhancing elements, including, but not limited to barbs, roughened and/or textured surface, an adhesive surface, disposed on the first arm.
  • the valve repair device includes a plurality of tethers attached to the plurality of anchors.
  • one or more tethers can be associated with a corresponding anchor.
  • the plurality of tethers are configured to pull the plurality of anchors against the central body. In some implementations, the plurality of tethers are further configured to allow the plurality of anchors to be spaced apart from the central body, e.g., when there is slack in the tethers.
  • a valve repair device e.g., a valve repair device to be used for repairing a heart of a real or simulated subject
  • the valve repair device includes a central body and a plurality of anchors.
  • an anchor of the plurality of anchors includes a gripping member having a first arm, a second arm, and a hinge portion that hingeably connects the first arm to the second arm.
  • each anchor includes a gripping member.
  • retracting the actuation element applies tension to the actuation element to cause the second arm to pivot in an opening direction.
  • the actuation element can be retracted in a retraction direction. Moving and/or pivoting the second arm in the opening direction can move the anchor, gripping member, and/or second arm toward an open condition.
  • the opening direction can be a counterclockwise direction.
  • the first alignment feature is a locking eyelet extending from the mounting plate and the second alignment feature is an opening in the central body for receiving the locking eyelet.
  • the central body includes a central bore.
  • one or more tethers extend through the central bore and out of an opening in the central body.
  • the opening is arranged to one side of the second alignment feature.
  • the anchor include a second mounting plate attached to the second arm of the gripping member.
  • each of the plurality of anchors includes a respective second mounting plate attached to the second arm of the gripping member.
  • the mounting plate includes a bore and an actuation element extends through the bore of the mounting plate to engage the paddle.
  • extending the actuation element in a distal direction causes the paddle to open and retracting the actuation element in a proximal direction causes the paddle to close.
  • extending the actuation element in a distal direction causes the paddle to close and retracting the actuation element in a proximal direction causes the paddle to open.
  • rotating the actuation element in a first direction causes the paddle to open and rotating the actuation element in a second direction causes the paddle to close.
  • the actuation element is a tube that extends through the bore of the mounting plate to engage a distal end of the paddle.
  • the distal end of the paddle has a proximally extending pin that is received by the actuation element.
  • the actuation element is tube-shaped.
  • the actuation element threadably engages the distal end of the paddle.
  • the valve repair device also includes a locking pin extending through a central bore of the central body.
  • a locking eyelet is attached to a mounting plate of the anchor.
  • each mounting plate is attached to a corresponding locking eyelet.
  • openings are provided in the central body for receiving the locking eyelets of the anchor and/or anchors.
  • the locking pin threadably engages with a threaded proximal opening of the central bore.
  • the locking eyelet of one anchor is offset from the locking eyelets of the other anchors so that the locking eyelets of all of the plurality of anchors can be moved into alignment with the locking pin.
  • the locking eyelets can be axially offset or staggered axially relative to each other. In some implementations, the locking eyelets are configured to align with a central longitudinal axis of the valve repair device when moved into alignment with the locking pin.
  • the valve repair device also includes a sheath extending along the actuation element to the paddle so that when the sheath is in an extended condition the sheath engages the bore of the mounting plate so that the anchor is engaged with the central body. When the sheath is retracted to a retracted condition, the anchor is able to move away from the central body.
  • each paddle is associated with a corresponding sheath.
  • the actuation element is biased to move the anchor laterally away from the central body when the sheath is retracted to the retracted condition.
  • the anchors are moved to a distally staggered bailout position by extending the actuation element and sheath for each anchor to a different distance.
  • the valve repair device includes a gripping member attached to the paddle of each anchor.
  • the gripping member has a first arm, a second arm, a hinge portion hingeably attaching the first arm to the second arm, and a secondary actuation element connected to the second arm.
  • a valve repair system includes a delivery system with one or more catheters and a control handle and any of the valve repair devices described herein.
  • the delivery system includes a positioning arm extending from a catheter of the delivery system to engage an anchor of the valve repair device.
  • the positioning arm comprises the actuation element of the valve repair device, e.g., the actuation element associated with the anchor of the valve repair device.
  • extending the positioning arm from the catheter allows the positioning arm to flex laterally to allow the anchor to move away from the central body.
  • the positioning arm is biased to flex laterally outward and away from the central body. [00294] In some implementations, retracting the positioning arm into the catheter causes the positioning arm to straighten so that the anchor is moved into engagement with the central body.
  • the delivery system further includes a guide extending through the positioning arm to a distal cap.
  • the distal cap is connected to the central body of the valve repair device.
  • the distal cap includes a stop for engaging the anchors when the anchors are moved into engagement with the distal cap.
  • extending the positioning arm moves the anchor along the guide and into engagement with the distal cap.
  • applying a force to the positioning arm in the extending direction after the anchor has engaged the distal cap compresses the positioning arm.
  • the positioning arm can comprise and/or be formed from a hypotube with a central lumen and a plurality of segments.
  • the plurality of segments of the hypotube are cut from a single tube.
  • each segment extends from a first end to a second end.
  • the first end and/or the second end include a plurality of retaining slots and a plurality of corresponding keyed retaining tabs.
  • the retaining slots are rotationally symmetric.
  • the retaining slots of the first end of a segment are rotationally offset from the retaining slots of the second end of the segment.
  • FIG. 20 illustrates the treatment/repair device of FIG. 19, with the anchors moved into contact with the central body.
  • FIG. 25 illustrates the valve repair system of FIG. 24 with two leaflets and two anchors tethered to a remainder of the valve repair device.
  • FIG. 26 illustrates the valve repair system of FIG. 25 with the two anchors and attached leaflets pulled back to the remainder of the valve repair device by the tethers.
  • FIG. 28 illustrates a valve repair system with anchors connected to native valve leaflets and tethered to a central body.
  • FIG. 29 illustrates the valve repair system of FIG. 28 with the anchors pulled to the central body by tethers.
  • FIG. 30 illustrates the valve repair system of FIG. 29 with the anchors pulled downward into the central body to move the anchors to a more upright position.
  • FIG. 31 illustrates the valve repair system of FIG. 30 where the delivery system has been separated from the device.
  • FIG. 32 illustrates a valve repair system with anchors connected to native valve leaflets and tethered to a central body.
  • FIG. 33 illustrates the valve repair system of FIG. 32 with the anchors pulled toward the central body by tethers.
  • FIG. 34 illustrates the valve repair system of FIG. 33 with the anchors pulled against the central body to move the anchors to a more upright position.
  • FIG. 35 is a perspective view of a valve repair system.
  • FIGS. 36 and 37 are top views of a valve repair system.
  • FIGS. 38-42 are schematic illustrations of a valve repair system.
  • FIG. 43 is a perspective view of a delivery system for delivering anchors to native heart valve leaflets.
  • FIG. 44 is a side view of a portion of a valve repair system.
  • FIG. 45 is a perspective view of a portion of the valve repair system illustrated by FIG. 44.
  • FIG. 46 is the top view of the valve repair system illustrated by FIG. 44.
  • FIG. 47 is a side view of a valve repair system that is similar to the valve repair system illustrated by FIG. 44.
  • FIG. 48 is a side view of a valve repair system that is similar to the valve repair system illustrated by FIG. 44.
  • FIGS. 49-56 are cross-sectional views of a valve repair system.
  • FIG. 57 illustrates a perspective view of an expandable/expansion member in an expanded configuration
  • FIG. 58 illustrates a perspective view of the expandable/expansion member of FIG. 57 in a collapsed configuration
  • FIG. 59 illustrates an exploded perspective view of the expandable/expansion member and an example actuation mechanism for the expandable coaptation element
  • FIG. 60 illustrates a sectional view of the expandable/expansion member and the actuation mechanism of FIG. 59;
  • FIG. 61 illustrates a sectional view of the expandable/expansion member and the actuation mechanism of FIG. 59;
  • FIG. 62 illustrates a perspective view of the expandable/expansion member and the actuation mechanism of FIG. 59;
  • FIG. 63 illustrates a front view of the expandable/expansion member and the actuation mechanism of FIG. 59;
  • FIG. 64 illustrates a front view of an example expandable/expansion member and an example actuation mechanism for an expandable coaptation element;
  • FIG. 65 illustrates an exploded view of the actuation mechanism of FIG. 64
  • FIG. 66 illustrates a sectional view of the expandable/expansion member and the actuation mechanism of FIG. 64;
  • FIG. 67 illustrates a sectional view of the expandable/expansion member and the actuation mechanism of FIG. 64;
  • FIG. 68 illustrates a perspective view of the sectioned expandable/expansion member and the actuation mechanism of FIG. 67 ;
  • FIG. 69 illustrates an example expandable/expansion member and an example actuation mechanism for an expandable coaptation element
  • FIGS. 70-72 are schematic illustrations of a valve repair system.
  • FIGS. 73 and 74A-74E are schematic illustrations of a valve repair system.
  • FIGS. 75A-75D illustrate a consecutively inserted, center-coupled implementation of a treatment/repair system.
  • FIG. 76 is a cutaway view of a central body of the consecutively inserted, center- coupled implementation of a treatment/repair system of FIGS. 25A-75D, being connected to an implant catheter and tethered anchors.
  • FIG. 77 is a cutaway view of an example central body, including a spacer.
  • FIG. 89 is side view of the valve repair device of FIG. 88 with a paddle in an option condition
  • FIG. 97 is a side view of a gripping member of a valve repair device showing the gripping member in a closed condition, wherein an actuation arm of an actuation element includes a tether for connecting to a second arm of the gripping member;
  • FIG. 98 shows the gripping member of FIG. 97 in an open condition and positioned to capture a valve leaflet
  • FIG. 99 shows the gripping member of FIG. 97 in a closed condition with a valve leaflet captured by the gripping member
  • FIG. 100 is a side view of a gripping member of a valve repair device showing the gripping member in a closed condition, wherein an actuation element extends from an opening in a central body that is disposed distally to a hinge portion of the gripping member;
  • FIG. 101 shows the gripping member of FIG. 100 in an open condition and positioned to capture a valve leaflet
  • FIG. 102 shows the gripping member of FIG. 100 in a closed condition with a valve leaflet captured by the gripping member
  • FIG. 104 is a side view of a gripping member of a valve repair device showing the gripping member in a closed condition, wherein an actuation element extends from an opening in a central body and around a routing member before engaging the gripping member;
  • FIG. 105 shows the gripping member of FIG. 104 in an open condition and positioned to capture a valve leaflet
  • FIG. 108 shows the gripping member of FIG. 104 in a closed condition with a valve leaflet captured by the gripping member and the routing member in the extended position;
  • FIG. 109 shows the gripping member of FIG. 104 in a closed condition with a valve leaflet captured by the gripping member and the routing member in the retracted position;
  • FIG. 110 is a side view of a gripping member of a valve repair device showing the gripping member in a closed condition, wherein a second arm of the gripping member includes a flexible portion and a head having a barbed end and a hook for engaging a catch member of a first arm of the gripping member;
  • FIG. 110A is a partial front view of the gripping member of FIG. 110;
  • FIG. 11 1 shows the gripping member of FIG. 110 in the closed condition with the head and barbed end of the second arm disengaged from the catch member of the first arm;
  • FIG. 112 shows the gripping member of FIG. 110 in an open condition and positioned to capture a valve leaflet
  • FIG. 115 is a side view of a gripping member of a valve repair device showing the gripping member in a closed condition, wherein a second arm of the gripping member includes a folding barbed portion in an extended condition;
  • FIG. 120 shows a top perspective view of an example of a valve repair device and its aesthetic features
  • FIG. 121 shows a top perspective view of the valve repair device of FIG. 120 with an anchor in an open condition
  • FIG. 122 shows a cross-sectional view of the valve repair device of FIG. 120
  • FIG. 133 shows a top perspective view of the valve repair device of FIG. 132 with the gripping member in an open condition
  • FIG. 134 shows a side view of the valve repair device of FIG. 133;
  • FIG. 135 shows a top perspective view of the valve repair device of FIG. 131 with an anchor in a released condition
  • FIG. 136 shows a bottom perspective view of the released anchor of the valve repair device of FIG. 135;
  • FIG. 137 shows a cross-sectional view of the valve repair device of FIG. 135
  • FIG. 138 shows a cross-sectional view of the valve repair device of FIG. 131 with the anchor in a retracted condition
  • FIG. 139 shows a cross-sectional view of the valve repair device of FIG. 131 with actuation elements locked
  • FIG. 140 shows a cross-sectional view of the valve repair device of FIG. 131 with a locking element retracted
  • FIG. 141 shows a cross-sectional view of the valve repair device of FIG. 131 with a handshake coupling decoupled
  • FIG. 142 shows a cross-sectional view of the valve repair device of FIG. 131 with a delivery mechanism retracted;
  • FIG. 143 shows a cross-sectional view of a catheter of the delivery mechanism of the valve repair device of FIG. 131;
  • FIG. 144 shows a top perspective view of an example of a valve repair device and its aesthetic features
  • FIG. 145 shows a top perspective view of the valve repair device of FIG. 144 with an anchor having a paddle in an open condition and a gripping member in a closed condition;
  • FIG. 146 shows a top perspective view of the valve repair device of FIG. 145 with the gripping member in an open condition
  • FIG. 147 shows a side view of the valve repair device of FIG. 146;
  • FIG. 148 shows a top perspective view of the valve repair device of FIG. 144 with an anchor in a released condition
  • FIG. 149 shows a bottom perspective view of the released anchor of the valve repair device of FIG. 148;
  • FIG. 150 shows a cross-sectional view of the valve repair device of FIG. 148
  • FIG. 151 shows a cross-sectional view of the valve repair device of FIG. 144 with the anchor in a retracted condition
  • FIG. 152 shows a cross-sectional view of the valve repair device of FIG. 144 with actuation elements locked
  • FIG. 153 shows a cross-sectional view of the valve repair device of FIG. 144 with a locking element retracted
  • FIG. 154 shows a cross-sectional view of the valve repair device of FIG. 144 with a handshake coupling decoupled
  • FIG. 155 shows a cross-sectional view of a catheter of the delivery mechanism of the valve repair device of FIG. 144;
  • FIG. 156 shows the valve repair device of FIG. 144 with anchors moved to an elongated position;
  • FIG. 157 shows a top perspective view of an example of a valve repair device and its aesthetic features
  • FIG. 158 shows the valve repair device of FIG. 157 with an anchor in an open condition
  • FIG. 159 shows a bottom perspective view of an anchor of the valve repair device of FIG. 157 in a closed condition
  • FIG. 160 shows a bottom perspective view of an anchor of the valve repair device of FIG. 158;
  • FIG. 161 shows a side view of the valve repair device of FIG. 158 positioned for leaflet capture
  • FIG. 162 shows a partial cross-sectional view of the valve repair device of FIG. 157 with an anchor in the retracted condition
  • FIG. 163 shows a partial cross-sectional view of the valve repair device of FIG. 162 with the anchor in a released condition
  • FIG. 164 shows a top perspective view of the valve repair device of FIG. 163 ;
  • FIG. 165 shows a cross-sectional view of an anchor locking mechanism of the valve repair device of FIG. 157;
  • FIG. 166 shows a perspective view of the anchor locking mechanism of the valve repair device of FIG. 157 ;
  • FIG. 167 shows a cross-sectional view of the valve repair device of FIG. 157 with an actuation element retracted
  • FIG. 168 shows a cross-sectional view of the valve repair device of FIG. 157 with a delivery mechanism retracted;
  • FIG. 169 shows a cross-sectional view of a catheter of the delivery mechanism of the valve repair device of FIG. 157;
  • FIG. 170 shows the valve repair device of FIG. 157 with anchors moved to a delivery configuration
  • FIG. 172 shows a side view of the valve repair device of FIG. 171 with the anchors in a retracted condition
  • FIG. 173 shows a side view of an example of a valve repair device with anchors in a released condition
  • FIG. 178 shows a top perspective view of a segment of the hypotube of FIG. 177;
  • FIG. 179 shows a top view of the hypotube of FIG. 177
  • FIG. 180 shows a side view of a hypotube and its aesthetic features usable and/or for use as an actuation element in a valve repair device
  • FIG. 181 shows a top perspective view of a segment of the hypotube of FIG. 180;
  • FIG. 182 shows a top view of the hypotube of FIG. 180;
  • FIG. 183 shows an enlarged view of the hypotube of FIG. 180 with the hypotube in a bent condition;
  • FIG. 184 shows an enlarged view of the hypotube of FIG. 180 with the hypotube in a straight condition.
  • Some implementations of the present disclosure are directed to systems, devices, methods, etc. for treating or repairing a defective heart valve.
  • various implementations of devices, valve repair devices, implantable devices, implants, and systems are disclosed herein, and any combination of these options can be made unless specifically excluded.
  • individual components of the disclosed devices and systems can be combined unless mutually exclusive or otherwise physically impossible.
  • the mitral valve MV and the tricuspid valve TV are more prone to deformation of leaflets and/or surrounding tissue, which, as described above, can prevent the mitral valve MV or tricuspid valve TV from functioning properly, allowing for the regurgitation or back flow of blood from the ventricle into the atrium (e.g., a deformed mitral valve MV may allow for regurgitation or back flow from the left ventricle LV to the left atrium LA, as depicted in FIG. 4).
  • the regurgitation or back flow of blood from the ventricle to the atrium results in valvular insufficiency. Deformations in the structure or shape of the mitral valve MV or the tricuspid valve TV are often repairable.
  • the systems, devices, procedures, and concepts disclosed herein are described in detail for treating/repairing the structure of a native valve, often using a mitral valve as an illustrative example.
  • the systems, devices, and procedures can be used between the anterior and posterior leaflets 20, 22 of the mitral valve MV to connect them and help prevent or inhibit regurgitation of blood from the left ventricle into the left atrium.
  • the devices, procedures and concepts disclosed herein can also be used to treat/repair a single leaflet of a native valve.
  • the other valves can be treated/repaired using the devices, procedures and concepts disclosed herein.
  • the devices, procedures and concepts can be used between any two of the three leaflets on the tricuspid valve (e.g., the anterior leaflet 30, the septal leaflet 32 and the posterior leaflet 34) to connect them and prevent or inhibit regurgitation of blood from the right ventricle into the right atrium.
  • the devices, procedures and concepts disclosed herein can be used between all three tricuspid valve leaflets 30, 32, 34 to connect all three of them and prevent or inhibit regurgitation of blood from the right ventricle to the right atrium.
  • the devices, procedures, systems, and concepts disclosed herein can also be used to treat/repair a single leaflet of a valve.
  • the described devices, procedures, systems, and concepts might be used to treat or repair any native valve, as well as any component of a native valve.
  • the systems herein can be configured as organ repair systems for repairing an organ, e.g., the heart, or a valve of a heart. In some implementations, the systems can be configured to treat/repair another part of the body. In some implementations, the systems herein are valve treatment/repair systems for repairing or treating a valve. In some implementations, the systems herein include a treatment and/or repair device (e.g., a valve repair device, a valve repair implant, a valve treatment device, a treatment device, an implant, a device, etc.).
  • a treatment and/or repair device e.g., a valve repair device, a valve repair implant, a valve treatment device, a treatment device, an implant, a device, etc.
  • the device can be delivered to the valve by the delivery system through the subject’s vascular system.
  • the delivery and/or implant catheter(s) can have a distal end for insertion into a proximal end of a steering catheter system, and a proximal end for manipulation by a user of the delivery system.
  • system is provided with a wide array of related parts and methods, such as may be described herein, either directly or indirectly.
  • An example transvascular technique that can be used with the systems, devices, methods, etc. herein for treating/repairing a native valve can comprise advancing a catheter or catheter device into an atrium (e.g., inserting the catheter device into the right femoral vein, up the inferior vena cava and into the right atrium).
  • the tricuspid valve is treated from the right atrium.
  • the septum can be punctured from the right atrium, and the catheter device passed into the left atrium.
  • the catheter device can be coupled to a device (e.g., treatment device, repair device, implant, etc.). The device can be positioned to repair a dysfunctional native valve.
  • the delivery systems herein can comprise one or more components forming a steering catheter system and/or an implant catheter system.
  • the delivery systems can have one or more components forming a steering catheter system and an implant catheter system.
  • the implant catheter system includes one or more implant catheters capable of placing and implanting, or otherwise deploying, a treatment or repair device.
  • the one or more implant catheters can be steerable catheters capable of navigating a subject’s vascular system, thereby also forming all or part of the steering catheter system rather than being a separate system.
  • the delivery system can further include additional devices for transvascular procedures, such as sheaths, control guidewire, external catheter control systems and controls (e.g., one or more of knobs, motors, buttons, switches, sliders, gears, motors, screws, cams, gimbles, etc.), and the like.
  • the one or more steering catheters can be either individually or collectively configured to guide the one or more implant catheters through the subject’ s vascular system. In some implementations, this can involve positioning a distal end of the steering catheter system upstream of a defective valve (relative to a blood flow direction) and pointing the distal end of the implant catheter system downstream (in the blood flow direction) through the valve.
  • the implant catheter system starts off inserted within the steering catheter system prior to its insertion into the subject’s body or is inserted into a proximal end of the steering catheter system after the steering catheter system’s distal end is positioned upstream of the valve. With the steering catheter system in place and the implant catheter inserted, the implant catheter system is extended downstream from within steering catheter system, toward the valve.
  • the component parts of the treatment/repair device can be configured to traverse the subject’s vascular system through the delivery system in an operational configuration.
  • the treatment/repair device can be structurally configured with a first, small-form-factor (e.g., small diameter) delivery configuration structurally laid out for traversing the delivery system through the subject’s vascular system, and a second, operational configuration structurally appropriate for valve treatment or repair operations.
  • the implant catheter includes one or more actuators functional to actuate the treatment/repair device from the delivery configuration to the operational configuration while the device is located at its installation location within the subject’ s heart.
  • the component parts of the device can be configured for simultaneously traversing the subject’s vascular system through the delivery system as a single implantable unit.
  • the component parts of the device can be configured to transvascularly traverse the delivery system through the subject’s vascular system on a piece- by-piece basis.
  • the pieces are assembled into an implantable device within the body (e.g., within the heart during an implantation procedure).
  • a treatment/repair system includes and uses a plurality of anchors (e.g., leaflet anchors, tissue anchors, clips, clasps, toggle anchors, staples, rivets, darts, etc.) that attach to tissue (e.g., tissue of an organ).
  • the system is in the form of and/or comprises a treatment or repair device that includes at least one of or a plurality of independently actuatable leaflet anchors (e.g., clips, clasps, clamps, toggle anchors, staples, rivets, darts, knots, etc.) are also possible.
  • a leaflet anchor is an attachment device structured (once it is in an operational configuration) with a leaflet-attachment mechanism to affix itself to a leaflet, in any one or more of a variety of ways.
  • This attachment mechanism can be, for example, in the form of an attachment-body (e.g., a bar).
  • attachment-bodies there will be a plurality of attachment-bodies (a first attachment-body, a second attachment-body, a third attachment-body, etc.), each of which can have any of a variety of cross sections (e.g., a relatively flat, paddle-type cross), and longitudinally extending in any of a wide variety of shapes (e.g., a straight line or a circle) to form compressive structures (e.g., paddles or rings).
  • the attachment-bodies can be configured affix to the leaflet, such as by pressing against the leaflet and thereby constraining the movement of the leaflet with respect to the anchor.
  • two attachment-bodies in the form of paddles can be configured such that they are attached at one end with a hinge to form a jaw that can bite down and clamp or clasp on to a leaflet and thereby affix to the leaflet.
  • this clasp-type anchor attachment apparatus (or attachment mechanism) can be provided with two control apparatuses (or control mechanisms), one that actuates the attachment apparatus between an open configuration and an attached configuration (optionally using a spring to load the jaw towards an open or closed position), and one that locks the attachment apparatus onto a leaflet.
  • the control apparatuses can be controlled using control wires, such as sutures, wires, lines, tethers, etc.
  • any leaflet anchor herein can be provided with various other forms of tissue-attachment mechanisms such as friction devices, adhesion devices, tissue piercing mechanisms and/or various forms of grapnel.
  • the anchor(s) can take and/or comprise a variety of forms, e.g., clasps, clamps, clips, darts, staples, hooks, bars, rods, screws, knots, toggle anchors, etc.
  • each leaflet anchor can comprise or be in the form of a toggle anchor, having a bar with a centrally attached respective anchor tether (e.g., a tether or tether section associated with a specific anchor).
  • the bar can be made to longitudinally pierce, penetrate, and pass through a wall of a leaflet, pulling the anchor tether with it like a needle pulling a thread. To do this maneuver, the bar can be oriented parallel to the anchor tether, and then an end of the bar is pushed through a wall of a leaflet using a sharp point or edge (the point either being on an end of the bar or on a separate penetrator that contains or is attached to the toggle anchor).
  • a structural support member can be used to support leaflet structures during penetration.
  • the anchor tether after passing through the wall, the anchor tether is pulled and the bar thereby toggles, (rotates) to laterally press against the wall of tissue with a distal (anchor) end of the anchor tether pulled back against, and extending back through, the penetrated wall of tissue in a T-shaped configuration (where the bar forms the top of an uppercase T).
  • This T-shaped toggle anchor also known as a T-element anchor
  • each anchor connector structurally fastens, couples, attaches, etc. the anchor and catheter together rigidly.
  • Each such anchor connector provides for the user (via the delivery or implant catheter system) to first position the associated anchor for affixing it to a valve portion like a leaflet, and then, after the anchor is affixed to that leaflet, with user actuation, to decouple, detach, or sever the connection provided by the anchor connector, and thereby unfasten and release the anchor from the implant catheter.
  • the decoupling/detaching/severing of the anchor connector thereby removes that connector’s constraint on the anchor from becoming separated from the implant catheter.
  • the implant catheter can then move separately away from the anchor, to, for example, position one or more other anchors at other leaflets or leaflet locations.
  • the central body is configured with a gapfilling shape, structure and composition that obstructs gaps between leaflets to reduce regurgitation.
  • the central body structure is shaped and positioned with respect to the leaflets such that, upon coaptation, opposing surfaces of the anchors, and their respective leaflets, close around the central body during appropriate portions of the cardiac cycle.
  • the central body/spacer can be configured to seal against opposing surfaces of two or three anchors, and thereby against two or three nativevalve leaflets, depending in part upon the type of valve for which it is adapted.
  • the central body/spacer can be shaped in any of a variety of shapes, as might be appropriate for the intended use.
  • the delivery or implant catheter 111 mounts and carries some or all portions of a device 101 (e.g., treatment device, repair device, valve treatment device, valve repair device, implantable device, implant, etc.).
  • device 101 comprise two leaflet anchors, e.g., a first leaflet anchor 113 and a second leaflet anchor 115.
  • each anchor has a respective leaflet- attachment mechanism (e.g., a first leaflet- attachment mechanism, and a second leaflet- attachment mechanism) in the form of an actuatable clip with independent actuators and actuation controls such that each anchor can be separately and independently affixed to respective leaflet locations.
  • the device is further provided with an optional central body 131 (e.g., a spacer, a coaptation element, a plug, a gap filler, etc.) and a centerbody connector 133.
  • the center-body connector 133 is a structural fastener that forms a center-body decouplable connection (e.g., detachable connections, severable connection, releasable connection, etc.) that fastens the central body 131 to the delivery/implant catheter 111 when in a connected state or unsevered state (e.g., it restricts and/or constrains their relative movement to be in-sync).
  • the anchoring systems, apparatuses, mechanisms, etc. for attaching the anchors to tissue herein can take a variety of different forms, e.g., clamping mechanisms, clasping mechanisms, suction mechanisms, adhering mechanisms, etc.
  • the anchoring systems, apparatuses, mechanism, etc. are separate and/or independent from systems, apparatuses, mechanisms, etc. for the controlled tether.
  • anchoring systems, apparatuses, mechanisms, etc. for attaching the anchors to tissue can be comparable to other anchor actuation systems, such as those that use sutures, threaded members, cams, shafts, and/or springs, etc. for controlled opening and closing of a clamp, clasp, etc.
  • a clamping system, apparatus, or mechanism is used to clamp onto tissue, e.g., onto a leaflet, for anchoring.
  • the drive link 306 is pivotably coupled to the optional follower 304 at a pivot axis 308.
  • the follower 304 is omitted and line the drive link 306 is pivotally connected directly to the actuation element 302.
  • the drive link 306 is pivotally connected to the outer paddle 117 at a pivot axis 310.
  • movement of the actuation element 302 in the direction 320 moves the drive link 306, which in turn moves the outer paddle toward 117 an open condition.
  • movement of the actuation element 302 in the direction 322 moves the drive link 306, which in turn moves the outer paddle toward a closed condition.
  • An optional biasing element can bias the outer paddle 117 toward or away from the inner paddle 119. Once in the closed position, the relative positions of the outer paddle 117 and the inner paddle 119 can optionally be locked.
  • a leaflet anchor 413 includes a first arm 417 and a second arm 419.
  • the first arm 417 and the second arm 419 are formed from a single piece curved and/or bent material, such as a piece of metal or plastic that has spring-like properties.
  • the first arm 417 and the second arm 419 are connected together at a closed end 430.
  • the first arm 417 and/or the second arm 419 are shape set to snap to a closed configuration (FIG. 10C) and to snap to an open configuration (FIG. 10D).
  • moving the first arm 417 past a center or snap-over line 420 in the direction indicated by arrow 422 causes the leaflet anchor to snap to the closed condition illustrated by FIG. 10C.
  • moving the first arm 417 past the center or snap-over line 420 in the direction indicated by arrow 424 causes the leaflet anchor to snap to the open condition illustrated by FIG. 10D.
  • FIGS. 10E and 10F illustrate an example of a clamping mechanism 500 that uses the leaflet anchor 413 illustrated by FIGS. 10C and 10D.
  • the clamping mechanism 500 includes a base 502 (e.g., a frame, a coaptation element, and/or a tube, etc.) an actuation element 504 (e.g., a wire, a hypotube, a flexible shaft, etc.), and the leaflet anchor 413.
  • the closed end 430 of the leaflet anchor 413 can be fixed to or coupled to a distal end 432 of the base 502.
  • the actuation element 504 can extend through the base 502 and can be releasably coupled to the first arm 417.
  • the first leaflet anchor 1 13 can be a separable anchor.
  • the user actuates a control decoupling or detaching the first anchor connector 121 and thereby releasing the first leaflet anchor from its primary connection to the implant catheter (e.g., its connection by the first anchor connector). Therefore, the central body and the implant catheter are freed to translate and rotate together in six degrees of freedom relative to the first leaflet anchor.
  • the decoupling or detachment of the separably attached first leaflet anchor 113 leaves only the first controlled tether 141 loosely connecting the first leaflet anchor 113 to the delivery /implant catheter 111.
  • the first anchor connector 121 provides for the delivery or implant catheter 111 and central body 131 to position the first leaflet anchor 113 in a correct position for affixing to the first leaflet 151, and then after the first leaflet anchor is affixed to the first leaflet, to decouple/detach/sever/release/unfasten the first leaflet anchor from the implant catheter, central body and second leaflet anchor 115.
  • the delivery/implant catheter 111, central body 131 and second leaflet anchor 115 can then move separately from the first leaflet anchor 113, such as to position the second leaflet anchor 115 at a second position within the heart, being located and oriented to grasp a first portion of the edge of a second leaflet 153 requiring constraint for improved operation (e.g., a first portion of the edge of the posterior leaflet 22).
  • the second leaflet anchor 1 15 can be a separable anchor.
  • the user then gives the first controlled tether 141 adequate slack to allow the implant catheter to freely move (with the second leaflet anchor 115 still attached) to a second location (such as at a location on a second leaflet 153 requiring constraint) without pulling the first leaflet anchor 113 and the first leaflet 151 along with it, and without being detrimentally pulled and tugged upon by the motion of the first leaflet due to the operation of the heart.
  • the user actuates the implant catheter to move the implant catheter and its attached portions of the device, positioning the second leaflet anchor at a second position within the heart, being located and oriented to grasp a first portion of the edge of a second leaflet 153 requiring constraint for improved operation (e.g., a first portion of the edge of the posterior leaflet 22). This positioning occurs without pulling the first leaflet anchor and the first leaflet to the second leaflet.
  • the user can controllably release (lengthen) slack on the first controlled tether 141 to provide for this movement without detrimental resistance from the first leaflet. This can be done by the user releasing slack on an end of the controlled tether suture at the proximal end of the implant catheter, as for other transvascular mechanisms having wires, chords, lines, etc. for control.
  • the implant catheter can then be actuated to position the second leaflet anchor 115 at the second position.
  • the second leaflet anchor 115 can then be actuated to attach it to the first portion of the edge of the second leaflet (e.g., the second leaflet anchor is actuated to clamp down on the leaflet edge to affix it to the leaflet).
  • the device 201 can optionally be structurally configured with a first, small-form- factor delivery configuration and a second, operational configuration configured for valve treatment or repair operations.
  • a small-form-factor, side-by-side serial delivery configuration e.g., spaced at 120° angles
  • a more complex delivery configuration might be necessary.
  • the implant catheter With the implant catheter extended from within steering catheter system, pointing downstream toward the tricuspid valve TV, the implant catheter moves downstream into and partially or entirely through the tricuspid valve to the extent needed based upon the geometry of the device and the valve. If it is first delivered to the heart in a delivery configuration, either before or after passing through the tricuspid valve TV, the implant catheter can actuate the device 201 from a delivery configuration to an operational configuration.
  • the implant catheter can be actuated to move the implant catheter and the device, positioning the first leaflet anchor 213 at a first position within the heart, being located and oriented to grasp a first portion of the edge of a first leaflet 251 requiring constraint for improved operation.
  • the first leaflet anchor 213 can then be actuated to attach it to the first portion of the edge of a first leaflet.
  • the first anchor connector can be decoupled/detached/severed/unfastened to release the first leaflet anchor from the implant catheter.
  • the central body 231 and implant catheter can be freed to translate and rotate together relative to the first leaflet anchor 213.
  • the decoupling or detachment of the separably attached first leaflet anchor 213 leaves only the first controlled tether 241 loosely connecting the first leaflet anchor 213 to the implant catheter.
  • the first anchor connector provides for the implant catheter and central body 231 to position the first leaflet anchor 213 in a correct position for affixing to the first leaflet 251, and then after the first leaflet anchor is affixed to the first leaflet, to unfasten and release the first leaflet anchor from the implant catheter, central body, second leaflet anchor 215 and third leaflet anchor 217.
  • the implant catheter, central body 231, second leaflet anchor 215 and third leaflet anchor 217 can then move separately from the first leaflet anchor 213 to position the second leaflet anchor 215 at a second position within the heart to grasp a first portion of the edge of a second leaflet 253 requiring constraint for improved operation.
  • the second anchor connector can be decoupled/detached/severed/unfastened to release the second leaflet anchor from the implant catheter.
  • the decoupling or detachment of the separably attached second leaflet anchor 115 leaves only the second controlled tether 143 loosely connecting the second leaflet anchor to the implant catheter.
  • first controlled-tether slack and second controlled-tether slack are not already adequate, slack on the first controlled tether 241 and second controlled tether 243 can be controllably released to provide for this movement without substantial detrimental resistance from the second leaflet 253.
  • the implant catheter can be actuated to position the third leaflet anchor 217 at the third position.
  • the third leaflet anchor 217 can be actuated to attach it to the first portion of the edge of the third leaflet.
  • the central body 23 can be provided with one or more mechanical locks (e.g., clips, clamps, portions that structurally mate, interlocking portions, etc.) to lock each tethered anchor in position and/or relative to each other.
  • mechanical locks e.g., clips, clamps, portions that structurally mate, interlocking portions, etc.
  • these are locked into contact and/or stationary relative to each other (e.g., completely stationary, mostly stationary, with portions that are stationary (e.g., contact surfaces) and other portions (e.g., extensions) that can move somewhat, etc.)
  • the first, second and third controlled tethers 241, 243, 245 and the implant catheter are disconnected from the device 201 and removed from the subject’ s body (see, FIG. 14). More particularly, the second- end segment of each controlled tether is freed to advance into the implant catheter (to pass up through the anchor slidable restraints and then back down the implant catheter) while the first- end segment is continuously pulled from the implant catheter until the full length of the controlled tether comes out of the implant catheter.
  • anchors By making one or more inserted anchors separable from one another (and the rest of the implant) prior to leaflet attachment, anchors can be attached to leaflets without resistance from other previously attached anchors. The device was placed without suffering the difficulties caused by leaflets having excessive spacing and movement.
  • this can offer additional structural support to a damaged leaflet at risk of further structural failure, and/or better attachment to a leaflet having characteristics indicating poor anchor-attachment characteristics.
  • two anchors on one leaflet can be placed adjacent to each other on the leaflet (e.g., in contact, etc.) or can be placed spaced apart along the leaflet.
  • the second leaflet anchor 115 can be inseparably connected to the central body 131 (e.g., connected to the central body without the use of a controllable anchor connector such that the second leaflet anchor cannot be controllably separated from the central body while within the body of a subject).
  • this inseparably connected anchor is still separably connected to the delivery/implant catheter 111, in that the central body 131 is separably connected to the implant catheter.
  • the first leaflet anchor 113 is separably connected to the central body 131 by a first anchor connector 121.
  • the first anchor connector 121 still provides for the delivery or implant catheter 111 to position the first leaflet anchor 1 13 in a correct position for affixing to the first leaflet 151, and then after the first leaflet anchor is affixed to the first leaflet 151, to decouple/detach/sever/unfasten and thereby release the first leaflet anchor from the implant catheter, central body 131 and second leaflet anchor.
  • the delivery/implant catheter 111 and central body 131 can then separate and move away from the first leaflet anchor 1 13, such as to position the second leaflet anchor 115 at a second position within the heart, where it can be attached to the first portion of the edge of the second leaflet 153.
  • the location of the second leaflet 153 is used as a coaptation location (to the extent that the catheter remains rigidly in place).
  • the leaflet structural forces and the dynamic blood flow forces from each leaflet will determine the actual location where the resulting device 101 will end up once the anchors are locked into position with respect to the central body (and one another), and the delivery/implant catheter 111 is disconnected from the de vice 101.
  • one anchor When combined three or more anchors, one anchor might be inseparable while the others are separable. In some implementations, two or more anchors might be inseparable while at least one is separable. In some implementations, greater flexibility during use is emphasized, e.g., with two separable anchors. In some implementations, the cost and size of a less complicated structure can be emphasized, e.g., with non or only one anchor separable.
  • the system (e.g., controlled tether system, tether system, etc.) includes one or more multi-anchor controlled tethers that each have an anchor-tether section with a plurality of anchor-tether segments (e.g., a first anchor-tether segment, a second anchor-tether segment and a third anchor-tether segment), each anchor-tether segment extending from an anchor-tether segment connection point (or a plurality of anchor-tether segment connection points) on the anchor-tether section to a respective one of the anchors having anchor connectors (thereby joining the anchor-tether segments).
  • anchor-tether segment e.g., a first anchor-tether segment, a second anchor-tether segment and a third anchor-tether segment
  • each anchor-tether segment extending from an anchor-tether segment connection point (or a plurality of anchor-tether segment connection points) on the anchor-tether section to a respective one of the anchors having anchor connectors (thereby joining the anchor-tether segments).
  • the anchor-tether segments can be connected at the connection points with connection mechanisms, or they can be unitary (e.g., form a unitary tether that is unitary at their connection points in their original formation).
  • the connection points can be located at or within the central body prior to and/or after the anchor connectors are decoupled/detached/severed.
  • the tethers 2841 are pulled into the openings 2827 to pull the anchors 2821 into the central body 2831 (and/or pull the central body 2831 over the anchors 2821).
  • the anchors 2821 are engaged between the retaining wall 2814 and the central post 2810 to rotate or pivot the anchors to a more upright or vertical position.
  • the tethered anchors 3421 can be opened and closed in a variety of different ways.
  • the inner arm 3460 and the outer arm 3462 can be pulled relatively apart to open and close the tethered anchors 3421.
  • the tilting flange or projection 3463 is fixed to and extends from a closed end 3423 of the tethered anchors 3421.
  • the tethered anchors are coupled to the central body 3431 by one or more control tethers 3441.
  • the one or more control tethers 3441 are positioned on and/or coupled to the anchors 3421 in a manner that allow the anchors to tilt as the anchors are pulled to the central body 3431.
  • the tethers are attached at or near a closed end 3423 of the anchors 3421.
  • the one or more control tethers 3441 can be used to selectively pull the anchors 3421 against and onto the central body 3431 and/or to be selectively slackened to allow the central body to move away from the anchors 3421.
  • the one or more control tethers 3441 and the central body 3431 are configured to pull the anchors toward the central body 3431 in a tilted orientation.
  • FIGS. 32-34 illustrate implantation of the device 3401 onto native heart valve leaflets 20, 22 or 30, 32, 34.
  • the tethered anchors 3421 have already been attached to two native valve leaflets 20, 22.
  • the tethered anchors 3421 could be attached to any number of native valve leaflets.
  • three tethered anchors 3421 can be attached to the three leaflets 30, 32, 34 of the native tricuspid valve.
  • the device can include any number of tethered anchors 3421 .
  • the tethers 3441 can be tied, locked or otherwise secured together to hold the anchors 3421 on (e.g., against) the central body 3431.
  • the anchors can be secured to the central body 3431 by something other than the tethers 3441.
  • the anchors and/or the central body 3431 can include a connection arrangement, fastener, or coupler that secures the anchors 3421 to the central body 3431.
  • the tethers 3441 or portions of the tethers that are proximal to an area where the tethers are tied, locked or otherwise secured together can be removed.
  • the device 3401 can be decoupled from the delivery system.
  • locks 3490 can be placed over the tethers 3441 to secure them in place relative to the central body 3431. This leaves the device 3401 secured to the native valve leaflets.
  • FIG. 35 illustrates an example of valve repair device 3401 that includes a base or bottom wall 3412 with a tapered upper surface 3510.
  • the tapered upper surface 3510 can be shaped to move the anchors 3421 more gradually to the more upright or vertical position and/or to control how upright the anchors 3421 become as the tilting flanges or projections 3463 are moved into engagement with the bottom wall 3412.
  • a shallow or less inclined tapered surface 3510 will move the anchors to a more upright position.
  • a steep or more inclined tapered surface 3510 will move the anchors to a less upright position.
  • the anchors 3421 of the FIG. 35 example can take a variety of different forms.
  • the plurality of tethered anchors can be any of the anchors disclosed by the present application.
  • the tethered anchors 3421 include an inner arm 3460 coupled to an inner mounting plate 3461, an outer arm 3462 mounted to an outer mounting plate 3465 that includes the tilting flange or projection 3463, and a hinge portion 3467 that connects the inner and outer arms 3460, 3462.
  • the outer arm 3462 can move between a closed position and an open position.
  • the outer arm 3462 can be biased by the hinge portion 3467 to the closed position relative to the inner arm 3460.
  • the tethered anchors 3421 can be opened and closed in a variety of different ways.
  • the anchors 3421 are opened by pressing or pulling on the tilting flange or projection 3463.
  • the outer arm 3462 can be biased by the hinge portion 3467 to the open position relative to the inner arm 3460 and the base or bottom wall 3412 can be moved distally or away from the tilting flange or projection 3463 to allow the outer arm 3462 to open.
  • the base or bottom wall 3412 can be moved back into engagement with the tilting flange or projection 3463 to close the outer arm 3462.
  • This configuration can be implanted in the same or a similar way as shown in the example of FIGS. 22-27.
  • FIGS. 36 and 37 are top views of an example of valve repair device 3401 that includes a base or bottom wall 3412 with extensions or petals 3610 and cutouts 3612.
  • the anchors 3421 can be moved to the more upright or vertical position in a variety of different ways.
  • the base or bottom wall 3412 is rotated to move the anchors 3421 between the tilted position and the upright position.
  • the anchors are free to assume the tilted position when the cutouts 3612 are aligned with the tilting flanges or projections 3463.
  • the tethered anchors 3421 can be opened and closed in a variety of different ways.
  • the anchors 3421 are opened by pressing or pulling on the tilting flange or projection 3463 when the cut outs 3612 are aligned with the tilting flanges or projections 3463.
  • the outer arm 3462 can be biased by the hinge portion 3467 to the closed position relative to the inner arm 3460. With the extensions or petals 3610 out of the way of the flanges or projections 3463, the outer arm 3462 and/or the tilting flanges or projections 3463 can be pushed or pulled by an actuator to open the anchors 3421.
  • a valve repair system 5200 includes a valve repair assembly 5201 with a plurality of anchors 5221 that are controlled by one or more catheters (not shown), such as any of the catheters disclosed herein.
  • the valve repair assembly can take a variety of different forms.
  • the valve repair assembly 5201 includes a center clip 5231, and the plurality of anchors 5221.
  • the center clip 5231 can take a variety of different forms.
  • the center clip 5231 can include a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application.
  • the center clip 5231 includes a central base 5210 and a plurality of clipping arms 5214 or an annular or semi-annular clipping wall.
  • the central base 5210 can take a variety of different forms.
  • An outer surface of the central base 5210 can be cylindrical or can have other shapes that are compatible with the shape of the native valve leaflets.
  • the plurality of clipping arms 5214 or an annular or semi-annular clipping wall can take a variety of different forms.
  • the clipping arms 5214 are biased to a closed or clamping configuration (See FIG. 42).
  • the plurality of clipping arms 5214 or an annular or semi-annular clipping wall can be elongated and/or straightened when loaded into a catheter 5252 (See FIG. 38).
  • the clipping arms 5214 can be made from a metal, such as steel or ni tinol. Any number of clipping arms can be included. In some implementations, the clipping arms 5214 are evenly spaced around a perimeter of the center base 5210 when the clipping arms are in the closed position. The size, number, and/or spacing of the clipping arms 5214 can be selected to approximate an annular wall around the center base 5210 when the clipping arms are in the closed position.
  • the clipping arms 5214 can move between a closed position and an open position.
  • the clipping arms 5214 can be biased (e.g. by shape setting, etc.) to the closed position.
  • the clipping arms can be opened and closed in a variety of different ways.
  • the tethers 5241 can draw the anchors 2821 toward one another.
  • the catheter 5252 can be positioned for deployment with the clipping arms 5214 in the catheter in the elongated configuration (see FIG. 38.).
  • the second arm 3992 can be moved to the open position in a variety of different ways.
  • a line 3996 e.g., suture, wire, chord, hypotube, etc.
  • the line 3996 can be attached to the second arm 3992 and pulled to open the gripping member 3933.
  • the hinge portion 3994 is shape set and/or provides a spring bias to bias the gripping member 3933 to the closed position. Relieving tension or slackening the line 3996 allows the gripping member 3933 to move to the closed position.
  • the device 3901 can be implanted onto native heart valve leaflets 20, 22 or 30, 32, 34.
  • the actuator end 3951 is moved in the direction 3991 by the proximal shaft.
  • the lower actuation extension, plate, or disc 3984 engages the lower extension or link 3965 and the upper actuation extension, plate, or disc 3985 engages the upper actuation extension or link 3964 of each of the paddles that are against the central body 3931 when the actuator end 3951 is moved proximally as indicated by arrow 3991.
  • the line 4296 can be pulled while the catheter 4297 is advanced to engage the actuating arm 4292 and move the gripping arm 4290 of the gripping member 3933 toward the open position, away from the single paddle arm 3960.
  • the gripping member 3933 can be biased to the closed position in the FIG. 47 example.
  • one or more of the lines 3996 can be pulled to move the second arm 3992 of the gripping member 3933 toward to the open position, away from the first arm 3990.
  • the gripping member 3933 can be biased to the closed position in the FIG. 48 example.
  • the device 3901 can be implanted by being moved to position a leaflet 20 in the open paddle arm 3960 and/or the optional open gripping member 3933.
  • the catheter 4297 can be retracted (FIG. 47) or the line 3996 can be slackened (FIG. 48) to close the gripping member 3933 and attach the gripping member 3933 to the first leaflet 20.
  • the actuator end 3951 can optionally be moved distally to close the first arm 3960 of all of the paddles 3915, with the first leaflet secured in the first anchor 3921.
  • the catheter 4297 or the line 3996 can be removed from the gripping member 3933 any at any time after the first leaflet is secured in the first anchor.
  • the one or more tethers 3941 are slackened to allow the remainder of the device 3901 to be moved away from the first leaflet 20 and the attached first anchor 3921 by one or more catheters of the valve repair system. This process can be repeated to attach all the anchors 3921 to the leaflets.
  • the tethers 3941 can be tied, locked or otherwise secured together to hold the anchors 3921 against the central body 3931.
  • the anchors can be secured to the central body 3931 by something other than the tethers 3941.
  • the anchors and/or the central body 3931 can include a connection arrangement, fastener, or coupler that secures the anchors 3921 to the central body 3931 when the anchors 3921 are pulled back against the central body 3931.
  • the tethers 3941 or portions of the tethers that are proximal to an area where the tethers are tied, locked or otherwise secured together can be removed.
  • the actuator end 3951 is moved distally (opposite of arrow 3991). This movement causes the upper actuation extension, plate, or disc 3985 to engage the lower extensions or links 3965 of all of the paddle arms 3960 to close all of the paddle arms.
  • the actuator end 3951 can be secured in place to set the closed position of the paddle arms.
  • the delivery system components can be decoupled from the device 3901, leaving the device 3901 secured to the native valve leaflets.
  • FIGS. 49-56 illustrate an example of a valve repair system 4400 that includes a valve repair device 4401 and a delivery system 4403.
  • the valve repair device 4401 includes a plurality of tethered anchors 4421 that are controlled by a plurality of spools 4450.
  • the valve repair device can take a variety of different forms.
  • the valve repair device 4401 includes a central body 4431 , a plurality of tethered anchors 4421 , and the plurality of spools 4450.
  • the central body 4431 can take a variety of different forms.
  • the central body 4431 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application.
  • the central body 4431 includes a bore 4435 that the spools 4450 are rotatably disposed in.
  • the central body 4431 can accept one or more shafts 4453 that are configured to rotate the spools 4450.
  • the plurality of tethered anchors 4421 can take a variety of different forms.
  • the plurality of tethered anchors can be any of the anchors disclosed by the present application.
  • the anchors 4421 each include a gripping member 4433, such as a clasp.
  • the tethered anchors 4421 can optionally be connected to the central body 4431 by an optional biasing member 4432, such as a spring, a shape set arm or wire, etc.
  • the biasing member can bias the tethered anchors to a selected position.
  • the optional biasing member 4432 can bias the anchors 4421 away from the central body 4431 (see the anchor 4421 on the right in FIG. 50).
  • the optional biasing member 4432 can bias the anchors 4421 toward from the central body 4431.
  • the central body 4431 can be moved away from the anchors 4421 due to attachment of the anchors to the leaflets and/or due to movement of the leaflets.
  • the gripping member 4433 can take a variety of different forms. In some implementations, the gripping member 4433 can be any of the gripping members or clasps disclosed herein. In some implementations, the gripping member 4433 includes a fixed arm 4490, a movable arm 4492, and a hinge portion 4494 that connects the fixed arm 4490 to the movable arm 4492. The gripping member can have optional barbs 4437.
  • the fixed arm 4490 is fixed to the biasing member 4432.
  • the movable arm 4492 can be moved relative to the fixed arm 4490 between an open position (left anchor in FIG. 50) and a closed position (right anchor in FIG. 50).
  • the movable arm 4492 can be moved relative to the fixed arm 4490 in a variety of different ways. In some implementations, further tensioning of tethers 4441 by the spools 4450 after the anchors 4421 are pulled up to the central body 4431 can cause the movable arm 4492 to open. The tethers 4441 can be attached to the movable arm 4492 and pulled to open the gripping member 4433.
  • the hinge portion 4494 is shape set and/or provides a spring bias to bias the gripping member 4433 to the closed position. Relieving tension or slackening the tether 4441 allows the gripping member 4433 to move to the closed position. Further slackening of the tether 4441 after the gripping member 4433 has moved to the closed position allows the anchor 4421 and the central body 4431 to be moved relatively apart.
  • the anchors 4421 are coupled to the central body 4431 by one or more control tethers 4441.
  • the one or more control tethers 4441 can extend from the movable arm 4492, into the central body 4431, and are wrapped around the spools 4450.
  • the one or more control tethers 4441 can be used to selectively pull the anchors 4421 against the central body 4431. In some implementations, once the anchors 4421 are against the central body 4431, the control tethers 4441 can be further pulled to move the anchors 4421 to the open position. The tethers 4441 can also be slackened to allow the anchors to close and allow the central body to move away from the anchors 4421.
  • the delivery system 4403 for implanting the device 4401 on a native heart valve can take a variety of different forms.
  • the delivery system includes a catheter 4480 and a plurality of shafts 4453 that are configured to rotate the spools 4450.
  • the catheter 4480 can be releasably coupled to the central body 4431 of the device 4401.
  • the plurality of shafts 4453 can be concentric shafts. A smallest of the shafts 4453 can be extended into the central body 4431 and to a distal one of the spools 4450, through any spools that are proximal to the distal spool. A middle sized one of the shafts 4453 can be extended into the central body 4431 and to a middle one of the spools, through any spools that are proximal to the middle spool.
  • the shaft when a shaft 4453 is engaged with its respective spool 4450, the shaft can rotate the spool in a first direction to selectively pull the anchors 4421 against the central body 4431 and then to pull the anchors 4421 to the open position.
  • the tethers 4441 can rotate the spool 4450 in a second direction to selectively slacken the tethers to allow the anchors to close and then allow the central body to move away from the anchors 4421.
  • the tether 4441 pulls on the movable arm 4492 to open the anchor 4421.
  • the device 4401 is moved by the delivery system 4403 to position a leaflet 20 in the open gripping member 4433 either before or after the anchor 4421 is opened.
  • a distal one of the spools 4450 is rotated by an inner or smallest one of the shafts 4453.
  • the spools can be used in any order. Rotation of the spool 4450 pulls on the corresponding tether 4441.
  • the tether 4441 pulls on the movable arm 4492 to open the anchor 4421.
  • the device 4401 is moved by the delivery system 4403 to position a leaflet 22 in the open gripping member 4433.
  • the tether 4441 can then be slackened to close the gripping member 4433 and attach the gripping member 4433 to the second leaflet 22.
  • the tether 4441 of the anchor connected to the leaflet 22 can be slackened to allow the remainder of the device 4401 to be moved away from the second leaflet 20 to allow the device to capture any additional leaflets. This process can be repeated for each spool, shaft and native valve leaflet.
  • shafts 4453 can be rotated, to rotate the spools 4450, and pull on the tethers 4441 to draw the anchors 4421 back against the central body 4431.
  • the spools are not rotated so far that the anchors start to reopen.
  • there can be a tactile indicator provided to an operator e.g., increased resistance in the tether
  • the tethers 4441 pull the native heart valve leaflets toward the central body.
  • the spools 4450 can be locked or otherwise secured to hold the anchors 4421 against the central body 4431.
  • the delivery system 4403 can be decoupled from the device 4401. This leaves the device 4401 secured to the native valve leaflets.
  • anchors are movable toward and away from on another by attaching the anchors to an expandable/expansion member 21018.
  • the expandable/expansion member 21018 can take a variety of different forms. Referring to FIG. 57A, an example of a valve repair device 5701 includes an expandable/expansion member 21018 and a plurality of anchors 5721.
  • the proximal end portion 21022 (FIGS. 57-63) of the expandable/expansion member 21018 includes a first pair of radially opposed openings 21036, and a second pair of radially opposed openings 21038 distal to the first pair of radially opposed openings 21036 and the distal end portion 21024 of the expandable/expansion member 21018 includes a third pair of radially opposed openings 21040.
  • the actuation mechanism 21020 is configured as a threaded connection.
  • the example actuation mechanism 21020 includes a distal member 21042 (e.g., tube, body, shaft, etc.) configured to threadably couple with a proximal member 21044 (e.g., tube, body, shaft, etc.).
  • the distal member 21042 and the proximal member 21044 can be configured in a variety of ways.
  • the distal member 21042 is formed as a cylindrical tube having a circular cross section. In some implementations, however, the distal member 21042 can have a shape other than cylindrical (e.g., a cross section that is oval, rectangular, elliptical, or other suitable shape).
  • the distal member 21042 includes a proximal end 21046, a distal end 21048 opposite the proximal end 21046, and an inner passage 21050 extending through the distal member 21042 from the proximal end 21046 to the distal end 21048.
  • the inner passage 21050 includes female threads 21052 (FIGS. 60-61) for threadably coupling with the proximal member 21044.
  • the distal member 21042 is sized to be received within the passage 21027 of the expandable/expansion member 21018.
  • the distal member 21042 includes structure for fixing the distal member 21042 in position within the passage 21027 relative to the expandable/expansion member 21018.
  • the distal end 21048 includes a pair of opposed projections 21054 configured to be received within the third pair of radially opposed openings 21040, as shown in FIGS. 60-63.
  • the proximal member 21044 is formed as a cylindrical tube having a circular cross section. In some implementations, the proximal member 21044 can have a shape other than cylindrical (e.g., a cross section that is oval, rectangular, elliptical, or other suitable shape).
  • the proximal member 21044 includes a proximal end 21056, a distal end 21058 opposite the proximal end 21056, and an inner passage 21059 extending through the proximal member 21044 from the proximal end 21056 to the distal end 21058.
  • the proximal member 21044 can include male threads 21060 (FIGS. 60-61) extending along at least a portion of the exterior of the proximal member 21044.
  • the male threads 21060 are configured to mate with the female threads 21052 of the distal member 21042.
  • the proximal member 21044 is sized to be received within the passage 21027 of the expandable/expansion member 21018.
  • the actuation mechanism 21020 can include structure for restricting axial movement of the proximal member 21044 within the passage 21027 relative to the expandable/expansion member 21018.
  • the structure restricts axial movement of the proximal member 21044 within the passage 21027 relative to the expandable/expansion member 21018 while allowing rotational movement of the proximal member 21044 relative to the expandable/expansion member 21018.
  • the structure for restricting axial movement of the proximal member 21044 can be configured in a variety of ways.
  • the actuation mechanism 21020 includes a circumferential, radially extending ridge 21062 at the proximal end 21056.
  • the ridge 21062 is configured to engage with a stop 21064 and an end cap 21066 to restrict axial movement of the proximal member 21044 within the passage 21027.
  • the stop 21064 can be configured in a variety of ways. In some implementations, the stop 21064 is configured to inhibit movement of the proximal member 21044 distally within the passage 21027.
  • the stop 21064 is formed as a ring having a central passage 21068 sized to receive a portion of the proximal member 21044 therethrough. In some implementations, the stop 21064 is further sized to be received within the passage 21027.
  • the stop 21064 can include structure configured to fix the position of the stop 21064 relative to the expandable/expansion member 21018.
  • the stop 21064 includes a pair of opposed projections 21070 configured to be received within the second pair of radially opposed openings 21038 of the expandable/expansion member 21018, as shown in FIGS. 60-63.
  • the distal member 22042 and the proximal member 22044 can be configured in a variety of ways.
  • the distal member 22042 is formed as a cylindrical tube having a side wall 22045 with a circular cross section.
  • the distal member 22042 can have a shape other than cylindrical (e.g., a cross section that is oval, rectangular, elliptical, or other suitable shape).
  • a valve repair system 7000 includes the valve repair device 7001 with a plurality of anchors 7021 that are tiltable toward and away from one another by an actuator 7050.
  • the valve repair device can take a variety of different forms.
  • the valve repair device 7001 includes a central body 7031, a plurality of anchors 7021, and an actuator end 7051.
  • the central body 7031 can take a variety of different forms.
  • the central body 7031 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application.
  • the central body 7031 includes a bore or passage 7035 that a shaft 7053 of the actuator end 7051 extends through and that inner tilting arms 7060 of paddles 7015 extend into.
  • the plurality of anchors 7021 can take a variety of different forms. In some implementations, the plurality of anchors can be any of the anchors disclosed by the present application.
  • the paddle 7015 can take a variety of different forms. In some implementations, the paddle 7015 can be any of the paddles disclosed by the present application. In some implementations, the paddle 7015 includes the inner tilting arm 7060 and an outer arm 7062. In some implementations, the outer arm 7062 can be pivotally and/or flexibly coupled to the inner arm 7060.
  • the outer arm 7062 can move between a closed position (FIG. 71) and an open position (FIG. 70).
  • the outer arm 7062 can be biased (e.g. with a spring, by shape setting, resilient flexing of the arm, etc.) to the closed position and is moved to the open position (e.g., in any of the ways disclosed herein) against the bias.
  • the outer arm 7062 can be biased (e.g. with a spring, by shape setting, resilient flexing of the arm, etc.) to the open position and moved to the closed position against the bias.
  • the outer arm 7062 is not biased open or closed.
  • the inner tilting arm 7060 is tilted by moving the actuator end 7051.
  • the inner tilting arm 7060 can be tilted by the actuator end 7051 in a variety of different ways. Any arrangement that allows all paddles 7015 that have at least a portion of the inner tilting arm 7060 in the bore or passage 7035 of the central body 7031 to be tilted toward and away from one another by the actuator end 7051 can be used.
  • FIGS. 70-72 engagement of a portion of the inner tilting arm 7060 in the central body 7031 by the actuator end 7051 tilts the inner arms 7060 toward or away from one another.
  • upward or proximal movement of the actuator end 7051 causes the inner arm 7060 to tilt inward or move to a more upright position.
  • downward or distal movement of the actuator end 7051 causes the inner arm 7060 to tilt outward or move to a more tilted position.
  • the outer arm 7062 is opened and/or closed relative to the inner arm 7060 with an actuation element 7150, such as a line, wire, hypotube, suture, etc.
  • an actuation element 7150 such as a line, wire, hypotube, suture, etc.
  • the outer arm 7062 is opened by pulling with the actuation element 7150. Any arrangement that allows the paddles 7015 to be opened and/or closed can be used.
  • the inner tilting arm 7060 of each paddle 7015 is coupled to the central body 7031 by the actuator 7050.
  • the inner tilting arm 7060 is optionally coupled by one or more tethers or other coupling arrangements that prevent or inhibit the inner tilting arm 7060 from completely separating from the central body 7031.
  • the actuator end 7051 can take a variety of different forms. Any arrangement that tilts the inner tilting arm 7060 of the paddles 7015 by pulling the inner tilting arm into the central body 7031 and/or pushing the inner tilting arm out of the central body 7031 can be used.
  • the actuator end 7051 includes the shaft 7053 and one or more actuation extension, plate, or disc 7084.
  • the actuation extension, plate, or disc 7084 can be configured such that engagement of the inner tilting arm 7060 of the paddle 7015 by the one or more actuation extension, plate, or disc 7084 tilts the inner tilting arms 7060 of the paddles toward or away from one another.
  • the tilting of the tilting arm 7060 can allow the one or more additional anchors 7021 to be moved to corresponding native valve leaflets while the first leaflet 20 is attached to the first anchor 7021.
  • the actuator end 7051 is moved distally to tilt all of the anchors 7021.
  • the actuator 7150 can be used to move the next paddle 7015 to an open position and one or more of the lines 7096 can be pulled to move the movable arm 7092 of the next gripping member 7033 toward an open position.
  • the device 7001 is moved to position a second leaflet 22 in the open gripping member 7033 and the outer arm 7062 of a second one of the anchors 7021.
  • the line 7096 can then be slackened to close the gripping member 7033 and attach the gripping member 7033 to the second leaflet 22.
  • the line 7096 can be removed from the gripping member 7033 any at any time after the second leaflet is secured in the first anchor.
  • the actuator 7150 can also move the second paddle to the closed position or the second paddle can be moved to the closed position after the anchors 5721 are tilted back together.
  • This process for capturing native valve leaflets can be repeated for a third anchor 7021 (if included) and any additional anchors (if included).
  • the actuator end 7051 can pull the tilt arms 7060 into the central body 7031 to move the anchors to a more upright orientation.
  • a valve repair device 7301 is configured to move gripping members 73608 inward (e.g. toward one another) and outward (away from one another).
  • the valve repair device 7301 can take a variety of different forms, such as any of the forms disclosed herein.
  • the valve repair device 7301 includes a central body 7331 and a plurality of anchors 7321.
  • the central body 7331 can take a variety of different forms.
  • the central body 7331 can be a spacer, coaptation element, gap filler, base, etc., such as any of the spacers, coaptation elements, gap fillers, and/or bases disclosed by this patent application.
  • the central body 7331 includes a bore or passage 7335 that one or more actuation elements extend into.
  • the central body 331 can be controllably inserted into the steering catheter 303, and the controlled tethers can be held to prevent or inhibit them from being drawn fully into the subject’s body (thereby causing the central body to advance toward the anchors along the controlled tethers).
  • an end-body 431 or lock (being similar in form and cinching function to the locking center bodies of prior examples and variations), is advanced along the tether 405 by proximally pulling on the tether.
  • the tether is pulled back through the end-body to draw the leaflet anchors 401, 421, 425, 427 together.
  • the anchors 401, 421, 425, 427 draw the leaflets 20, 22 together to reduce regurgitation through the native valve in the area of the anchors.
  • the intermediate leaflet anchors 421 , 425 naturally adjust their positions on the tether 405.
  • a distal leaflet anchor 451 is permanently affixed to a single, unitary controlled tether 453 (e.g., it is unitary in that it is not made of separate sections) that is long enough to extend through the length of the steering catheter from its distal to its proximal end.
  • intermediate leaflet anchors 455 and a proximal leaflet anchor 457 can have anchor-tether sections 459 that are strung on the unitary controlled tether 453.
  • a tether cutting device in an implant catheter is employed to cut off and remove most of the long, unitary controlled tether 453 from the implant after the implant is fully assembled and the anchors are cinched together by the end-body 431.
  • one or more (springtype) spring spacers 471 are placed on the segments of implant-controlled tether 473 extending between some or all consecutive pairs of leaflet anchors 475 that are attached to leaflets 477 (e.g., pairs of leaflet anchors that occur consecutively along the implant-controlled tether).
  • the one or more spring spacers 471 are placed by feeding them up the extension-tether section, each being fed between a respective consecutive pair of anchors that the spring spacer will separate. These spring spacers can help maintain anchors at preferred distances from one another.
  • these spring spacers 471 can be formed as one of the forms of spacer described above, or they can be of other configurations, such as an accordion-folded pledget, wherein the implant-controlled tether 473 penetrates and extends through each accordion fold (as depicted).
  • the anchors are configured as T-shaped toggle anchors. This type of anchor can provide for enhanced support for lateral loads occurring between consecutive anchors, and particularly on consecutive anchors attached to different leaflets. Other types of anchors are also possible (e.g., anchors described elsewhere herein).
  • a valve repair device is configured to be attached to two leaflets, pull the leaflets together during systole, and allow the leaflets to move apart during diastole.
  • the device can be configured to pull the leaflets together during systole and allow the leaflets to move apart during diastole in a variety of different ways.
  • a valve repair device 8201 includes a pair of anchors 8221 and a resilient coupling member 8231.
  • the pair of anchors 8221 can take a variety of different forms.
  • the pair of anchors 8221 can be any of the anchors disclosed herein.
  • the anchors 8221 each include a first arm 8290, a second arm 8292, and a hinge portion 8294 that connects the first arm 8290 to the second arm 8292.
  • the anchor 8221 can have optional barbs 8237.
  • the resilient coupling member 8231 can take a variety of different forms.
  • the resilient coupling member 8231 can be an elastic member, such as an elastic cord, spring, etc.
  • the coupling member 8231 has a fixed unbiased or unstretched length. Lengths of the coupling member 8231 with a fixed unbiased or unstretched length can be selected outside a patient’s body before delivery and implantation of the device 8201. When more than one device 8201 is used, the resilient coupling members can optionally have different lengths.

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un dispositif implantable destiné à être positionné à l'intérieur d'une valvule cardiaque, à l'aide d'un système de pose. Le dispositif peut comprendre des ancrages de feuillet destinées à être fixées à des feuillets valvulaires. Un ensemble d'attaches peut rapprocher les ancrages, en contact les uns avec les autres, et/ou en contact avec un corps central. L'ensemble d'attaches peut permettre aux ancrages de s'écarter, et/ou de s'éloigner d'un corps central.
PCT/US2025/021396 2024-03-26 2025-03-25 Dispositifs et procédés de réparation de valvule cardiaque Pending WO2025207671A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202463569803P 2024-03-26 2024-03-26
US63/569,803 2024-03-26
US202463638892P 2024-04-25 2024-04-25
US63/638,892 2024-04-25

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