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WO2025231088A1 - Dispositif d'amarrage de prothèse valvulaire ayant un bouchon compressible pour atténuation de fuite périvalvulaire au niveau de la commissure médiale - Google Patents

Dispositif d'amarrage de prothèse valvulaire ayant un bouchon compressible pour atténuation de fuite périvalvulaire au niveau de la commissure médiale

Info

Publication number
WO2025231088A1
WO2025231088A1 PCT/US2025/027013 US2025027013W WO2025231088A1 WO 2025231088 A1 WO2025231088 A1 WO 2025231088A1 US 2025027013 W US2025027013 W US 2025027013W WO 2025231088 A1 WO2025231088 A1 WO 2025231088A1
Authority
WO
WIPO (PCT)
Prior art keywords
docking device
compressible
coil
plug
scaffold
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/US2025/027013
Other languages
English (en)
Inventor
Kurt Kelly REED
Kevin Gantz
Darshin S. PATEL
Sean Chow
Tram Ngoc NGUYEN
Gianfranco Melino PELLEGRINI
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 WO2025231088A1 publication Critical patent/WO2025231088A1/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
    • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
    • 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
    • A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
    • A61F2250/0063—Nested prosthetic parts
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0069—Sealing means

Definitions

  • the present disclosure relates to a prosthetic valve docking device having a compressible plug for perivalvular leakage mitigation at the medial commissure.
  • Prosthetic valves can be used to treat cardiac valvular disorders.
  • Native heart valves for example, the aortic, pulmonary, tricuspid and mitral valves
  • These heart valves can be rendered less effective by congenital, inflammatory, infectious conditions, etc. Such conditions can eventually lead to serious cardiovascular compromise or death.
  • a transcatheter technique for introducing and implanting a prosthetic heart valve using a catheter in a manner that is less invasive than open heart surgery can reduce complications associated with open heart surgery.
  • a prosthetic valve can be mounted in a compressed state on the end portion of a catheter and advanced through a blood vessel of the patient until the valve reaches the implantation site.
  • the valve at the catheter tip can then be expanded to its functional size at the site of the defective native valve, such as by inflating a balloon on which the valve is mounted or, for example, the valve can have a resilient, self-expanding frame that expands the valve to its functional size when it is advanced from a delivery sheath at the distal end of the catheter.
  • the valve can have a balloon-expandable, self-expanding, mechanically-expandable frame, and/or a frame expandable in multiple or a combination of ways.
  • a transcatheter heart valve may be appropriately sized to be placed inside a particular native valve (for example, a native aortic valve).
  • the THV may not be suitable for implantation at another native valve (for example, a native mitral valve) and/or in a patient with a larger native valve.
  • the native tissue at the implantation site may not provide sufficient structure for the THV to be secured in place relative to the native tissue. Accordingly, improvements to THVs and the associated transcatheter delivery apparatus are desirable.
  • the present disclosure relates to methods and devices for treating valvular regurgitation and/or other valve issues. Specifically, the present disclosure is directed to a docking device having a compressible plug that is configured to receive a prosthetic valve, as well as the methods of assembling the docking device and implanting the docking device.
  • a docking device for securing a prosthetic valve at a native valve.
  • the docking device can include a coil comprising a plurality of helical turns when in a deployed orientation.
  • the docking device can include a compressible plug attached to the coil by being coupled to at least a portion of a helical turn thereof.
  • the compressible plug is movable between a radially compressed state in a delivery orientation and a radially expanded state in the deployed orientation.
  • the compressible plug includes: a compressible scaffold formed from a shape-memory material; and a plugging component operably coupled with the compressible scaffold to provide a liquid plugging function to the compressible plug.
  • the plugging component can include a cover (e.g., internal or external), absorbent members, or compressible members (e.g., hydrophobic), or others.
  • a docking device for securing a prosthetic valve at a native valve can include a coil, guard member, and compressible plug.
  • the coil can include a plurality of helical turns when in a deployed orientation
  • the guard member can be attached to the coil by being coupled to at least a portion of a helical turn thereof.
  • the guard member includes a scaffold with a spine and a plurality of arms extending from the spine. The plurality of arms are coupled to a flap.
  • the guard member is movable between a radially compressed state in a delivery orientation and a radially expanded state in the deployed orientation.
  • the compressible plug is attached to the coil (e.g., distal or proximal of the guard member) by being coupled to at least a portion of a helical turn of the coil.
  • the compressible plug is movable between a radially compressed state in a delivery orientation and a radially expanded state in the deployed orientation.
  • the compressible plug includes: a compressible scaffold formed from a shape-memory material; and a plugging component operably coupled with the compressible scaffold to provide a liquid plugging function to the compressible plug.
  • a method for making the docking device of one of the embodiments can be provided. The method can include forming a plurality of wires of a shape-memory material into the compressible scaffold. Then, a cover can be attached to the compressible scaffold to form the compressible plug. A coil is obtained, and the compressible plug is coupled to the coil.
  • a method of configuring a docking device for delivery to a native valve can include providing the docking device of one of the embodiments and compressing the compressible plug and optionally the guard member by compressing the compressible scaffold into the delivery orientation.
  • the compressible plug and the optional guard member can be compressed into the delivery orientation and inserted into a dock sleeve of a dock delivery system.
  • a method of implanting a docking device into a native valve can include providing the docking device of one of the embodiments and delivering the docking device to a native valve while the docking device is in a delivery orientation.
  • the coil can be deployed at an annulus of the native valve.
  • the compressible plug can be deployed into the deployed orientation at a position at the native valve so that the compressible plug overlays or presses against or at least partially penetrates a medial commissure of a native valve and/or native heart chamber associated with the native valve.
  • a method of implanting a prosthetic valve can include providing the docking device of one of the embodiments and delivering the docking device to a native valve. Then, the method can include deploying the docking device at an annulus of the native valve so that the compressible plug expands into the deployed orientation at a position at the native valve so that the compressible plug overlays or presses against or at least partially penetrates the medial commissure of the native valve and/or native heart chamber associated with the native valve. Then, a prosthetic valve can be deployed within the docking device. During the procedure, the coil remains in a substantially straight delivery orientation when delivering the docking device and moves to a helical configuration during deployment of the docking device when transitioning to the deployed orientation.
  • the compressible plug remains in a folded delivery orientation when delivering the docking device and moves to an unfolded deployed orientation after the docking device is deployed.
  • the methods described herein can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example, with body parts, heart, tissue, etc. being simulated).
  • FIG. 1 A is a cutaway view of the human heart in a diastolic phase.
  • FIG. IB is a cutaway view of the human heart in a systolic phase.
  • FIG. 2A schematically illustrates a first stage in an exemplary mitral valve replacement procedure where a guide catheter and a guidewire are inserted into a vasculature of a patient and navigated through the vasculature and into a heart of the patient, towards a native mitral valve of the heart.
  • FIG. 2B schematically illustrates a second stage in the exemplary mitral valve replacement procedure where a docking device delivery apparatus extending through the guide catheter is used to deploy a docking device at the native mitral valve.
  • FIG. 3A schematically illustrates a third stage in the exemplary mitral valve replacement procedure where the docking device of FIG. 2B is fully implanted at the native mitral valve of the patient and the docking device delivery apparatus has been removed from the patient.
  • FIG. 3B schematically illustrates a fourth stage in the exemplary mitral valve replacement procedure where a prosthetic heart valve delivery apparatus extending through the guide catheter is used to deploy a prosthetic heart valve within the implanted docking device at the native mitral valve.
  • FIG. 4A schematically illustrates a fifth stage in the exemplary mitral valve replacement procedure where the prosthetic heart valve is fully implanted within the docking device at the native mitral valve and the prosthetic heart valve delivery apparatus has been removed from the patient.
  • FIG. 4B schematically illustrates a sixth stage in the exemplary mitral valve replacement procedure where the guide catheter and the guidewire have been removed from the patient.
  • FIG. 5A illustrates an embodiment of a scaffold of a compressible plug adapted for implantation at a medial commissure of a mitral valve.
  • FIG. 5B illustrates another embodiment of a scaffold of a compressible plug with flared ends adapted for implantation at a medial commissure of a mitral valve.
  • FIG. 5C illustrates an embodiment of a scaffold of a compressible plug with a shell and core arrangement that is adapted for implantation at a medial commissure of a mitral valve.
  • FIG. 6A includes a top view that illustrates an embodiment of a coil of a docking device.
  • FIG. 6B includes a cross-sectional profile of the coil in FIG. 6A.
  • FIG. 6C includes a cross-sectional profile of the coil in FIG. 6A.
  • FIG. 6D includes a top view that illustrates an embodiment of a coil and compressible plug of a docking device.
  • FIG. 6E includes a side view that illustrates an embodiment of a coil and compressible plug of a docking device of FIG. 6D.
  • FIG. 7 A includes a top view that illustrates an embodiment of a scaffold of a guard member of a docking device.
  • FIG. 7B includes a top view that illustrates an embodiment of a flap of a guard member of a docking device.
  • FIG. 7C includes a perspective view that illustrates an embodiment of an assembled docking device having the coil and guard member.
  • FIG. 7D includes a top view of the docking device of FIG. 7C.
  • FIG. 7E includes a top view of the docking device having the compressible plug and an optional guard member.
  • FIG. 7F includes a perspective view that illustrates an embodiment of an assembled docking device having the coil and optional guard member.
  • FIG. 8A illustrates a compressible plug having a bulbous shape that is offset from the coil axis.
  • FIG. 8C illustrates a compressible plug having a flat shape, such as a disc or plate, which can be used for minimizing risk of leaflet endothelialization.
  • FIG. 8D illustrates a cross-sectional view of a compressible plug having a scaffold filled with pluggable members, which can be absorbent or hydrophobic, and can be compressible.
  • FIG. 9A illustrates a compressible plug having first body region with a bulbous shape with a hood forming an angled leading edge, and a second body region with a disc shape, which can be used to press against or through the medial commissure.
  • FIG. 10A illustrates a compressible plug having first body region with a conical shape with a tapered body, a throat region, and a second body region with a disc shape, which can be used to press against or through the medial commissure.
  • FIG. 10B includes side perspective view of the compressible plug of FIG. 10A.
  • FIG. IOC includes another side perspective view of the compressible plug of FIG. 10A.
  • FIG. 11A include a schematic diagram of a compressible scaffold of a compressible plug being elongated by longitudinal forces (e.g., stretching).
  • FIG. 11C includes a perspective view of a docking device having a compressible plug with a cover that is attached at an end to a coil, where an optional guard member is shown.
  • FIG. 11D includes a perspective view of a docking device having a compressible plug without a cover (e.g., may contain absorbable or compressible members in the compressible plug) that is attached at an end to a coil, where an optional guard member is shown.
  • a compressible plug without a cover e.g., may contain absorbable or compressible members in the compressible plug
  • FIG 12. shows the docking device being implanted into the mitral valve so that the compressible plug is at the medial commissure and the guard member is on the left atrium side, with the proximal coil region extending into the left atrium, wherein as shown, the plug scaffold is extended in the deployed orientation so that the three-dimensional shape covers over the medial commissure of the mitral valve anatomy, which can block a paraval vular leak (PVL).
  • PVL paraval vular leak
  • FIG. 13A shows the docking device being implanted into the mitral valve so that the compressible plug extends through the medial commissure to function as a plug, with the proximal coil region extending into the left atrium, where the coil of the docking de vice is shown to clock clockwise.
  • FIG. 13B shows the docking device being implanted into the mitral valve so that the compressible plug extends through the medial commissure to function as a plug, with the proximal coil region extending into the left atrium, where the coil of the docking de vice is shown to clock counterclockwise.
  • the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise.
  • the term “includes” means “comprises.”
  • the terms “coupled” and “connected” generally mean electrically, electromagnetically, fluidly, anatomically, and/or physically (for example, mechanically or chemically) coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.
  • the term “and/or” used between the last two of a list of elements means any one or more of the listed elements.
  • the phrase “A, B, and/or C” means “A”, “B,”, “C”, “A and B”, “A and C”, “B and C”, or “A, B, and C.”
  • proximal refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site.
  • distal refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site.
  • proximal motion of a device is motion of the device away from the implantation site and toward the user (for example, out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (for example, into the patient’s body).
  • valve or docking station typically the lower end of a valve or docking station as depicted in the figures is its inflow end and the upper end of the valve or docking station is its outflow end unless explicitly described otherwise.
  • longitudinal and axial refer to an axis extending in the upstream and downstream directions, or in the proximal and distal directions, unless otherwise expressly defined.
  • integrally formed and “unitary construction” refer to a construction that does not require any sutures, fasteners, or other securing means to attach two portions of the construction together.
  • Described herein are various systems, apparatuses, methods, or the like, that can be used in or with delivery apparatuses to deliver a prosthetic implant (e.g., a prosthetic valve, a docking device, etc.) into a patient body.
  • a prosthetic implant e.g., a prosthetic valve, a docking device, etc.
  • a delivery apparatus can be configured to deliver and implant a docking device at an implantation site, such as a native valve annulus.
  • the docking device can be configured to more securely hold an expandable prosthetic valve implanted within the docking device, at the native valve annulus.
  • a docking device can provide or form a more circular and/or stable anchoring site, landing zone, or implantation zone at the implant site, in which a prosthetic valve can be expanded or otherwise implanted.
  • replacement prosthetic valves can be more securely implanted and held at various valve annuluses, including at the mitral annulus which does not have a naturally circular cross-section.
  • the docking device can be arranged within an outer shaft of the delivery apparatus.
  • a sleeve shaft can cover or surround the docking device within the delivery apparatus and during delivery to a target implantation site.
  • a pusher shaft can be disposed within the outer shaft, proximal to the docking device, and configured to push the docking device out of the outer shaft to position the docking device at the target implantation site.
  • the sleeve shaft can also surround the pusher shaft within the outer shaft of the delivery apparatus. After positioning the docking device at the target implantation site, the sleeve shaft can be removed from the docking device and retracted back into the outer shaft of the delivery apparatus.
  • Fluid e.g., a flush fluid, such as heparinized saline or the like
  • a pusher shaft lumen defined within an interior of the pusher shaft
  • a delivery shaft lumen defined between the sleeve shaft and the outer shaft of the delivery apparatus
  • a sleeve shaft lumen defined between the pusher shaft and the sleeve shaft.
  • FIGS. 1 A and IB are cutaway views of the human heart H in diastolic and systolic phases, respectively.
  • the right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA, respectively, by the tricuspid valve TV and the mitral valve MV; i.e., the atrioventricular valves.
  • the aortic valve AV separates the left ventricle LV from the ascending aorta AA and the pulmonary valve PV separates the right ventricle from the pulmonary artery PA.
  • Each of these valves has flexible leaflets extending inward across the respective orifices that come together or "coapt" in the flow stream to form one-way, fluid-occluding surfaces.
  • the docking stations of the present application are described, for illustration, primarily with respect to the inferior vena cava IVC, superior vena cava SVC, mitral valve MV, and aorta/aortic valve.
  • a defective mitral valve can suffer from insufficiency and/or regurgitation.
  • the blood vessels such as the aorta, inferior vena cava IVC, superior vena cava SVC, pulmonary artery PA, may be healthy or may be dilated, distorted, enlarged, have an aneurysm, or be otherwise impaired.
  • Anatomical structures of the right atrium RA, right ventricle RV, left atrium LA, and left ventricle LV will be explained in greater detail.
  • the devices described herein can be used in various areas whether explicitly described herein or not, e.g., in the inferior vena cava IVC and/or superior vena cava SVC, in the aorta (e.g., an enlarged aorta) as treatment for a defective mitral valve, in other areas of the heart or vasculature, in grafts, etc.
  • aorta e.g., an enlarged aorta
  • the right atrium RA receives deoxygenated blood from the venous system through the superior vena cava SVC and the inferior vena cava IVC, the former entering the right atrium from above, and the latter from below.
  • the hepatic veins 17 carry blood from the liver to the inferior vena cava IVC.
  • the coronary sinus CS is a collection of veins joined together to form a large vessel that collects deoxygenated blood from the heart muscle (myocardium), and delivers it to the right atrium RA.
  • diastolic phase, or diastole seen in FIG.
  • the deoxygenated blood from the inferior vena cava IVC, superior vena cava SVC, and coronary sinus CS that has collected in the right atrium RA passes through the tricuspid valve TV and into the right ventricle RV as the right ventricle RV expands, while blood from the left atrium LA passes through the mitral valve MV into the left ventricle LV.
  • the systolic phase, or systole seen in FIG.
  • the right ventricle RV contracts to force the deoxygenated blood collected in the right ventricle RV through the pulmonary valve PV and pulmonary artery into the lungs, while the left ventricle LV contracts to force blood in the left ventricle through the Aortic Valve AV into the Ascending Aorta AA.
  • the devices described herein can be used to supplement the function of a defective mitral valve.
  • the leaflets of a normally functioning mitral valve MV close to prevent the blood from regurgitating back into the left atrium LA.
  • blood can backflow or regurgitate into the left atrium LA.
  • Blood regurgitating backward into the left atrium LA increases the volume of blood in the atrium and the blood vessels that direct blood to the heart. This can cause the left atrium LA to enlarge and cause blood pressure to increase in the left atrium LA and blood vessels, which can cause damage to and/or swelling of the liver, kidneys, legs, other organs, etc.
  • a transcatheter heart valve (THV) implanted in the mitral valve MV can inhibit blood from backflowing into the left atrium LA during the systolic phase.
  • TSV transcatheter heart valve
  • the left atrium LA receives oxygenated blood from the left and right pulmonary veins, which then travels through the mitral valve to the left ventricle.
  • the oxygen rich blood that collects in the left atrium LA passes through the mitral valve MV and into the left ventricle LV as the left ventricle LV expands.
  • the left ventricle LV contracts to force the oxygen rich blood through the aortic valve AV and aorta into the body through the circulatory system.
  • the devices described herein can be used to supplement or replace the function of a defective mitral valve MV.
  • FIGS. 2A-4B An exemplary transcatheter heart valve replacement procedure which utilizes a first delivery apparatus to deliver a docking device to a native valve annulus and then a second delivery apparatus to deliver a prosthetic transcatheter heart valve (THV) inside the docking device is depicted in the schematic illustrations of FIGS. 2A-4B.
  • TSV prosthetic transcatheter heart valve
  • THVs may not be able to sufficiently secure themselves to the native tissue (for example, to the leaflets and/or annulus of the native heart valve) and may undesirably shift around relative to the native tissue, leading to paravalvular leakage (PVL), valve malfunction, THV embolism, and/or other issues.
  • PVL paravalvular leakage
  • a docking device may be implanted first at the native valve annulus and then the THV can be implanted within the docking device to help anchor the THV to the native tissue and provide a seal between the native tissue and the THV.
  • FIGS. 2A-4B depict an exemplary THV replacement procedure (e.g., amitral valve replacement procedure) which utilizes a docking device 52 (e.g., with guard member as described herein) and a prosthetic heart valve 62, according to one example.
  • a user can create a pathway to a patient’s native heart valve using a guide catheter 30 (FIG. 2A).
  • the user can deliver and implant the docking device 52 at the patient’s native heart valve using a docking device delivery apparatus 50 (FIG. 2B) and then removes the docking device deliver ⁇ ' apparatus 50 from the patient 10 after implanting the docking device 52 (FIG. 3A).
  • the user can then implant the prosthetic heart valve 62 within the implanted docking device 52 using a prosthetic valve delivery apparatus 60 (FIG. 3B). Thereafter, the user can remove the prosthetic valve delivery apparatus 60 from the patient 10 (FIG. 4A), as well as the guide catheter 30 (FIG. 4B).
  • FIG. 2A depicts a first stage in a mitral valve replacement procedure, according to one example.
  • the guide catheter 30 and a guidewire 40 can be inserted into a vasculature 12 of a patient 10 and navigated through the vasculature 12, into a heart 14 of the patient 10, and toward the native mitral valve 16 (e.g., through heart tissue wall between right atrium RA to left atrium LA as shown).
  • the guide catheter 30 can provide a path for the docking device delivery apparatus 50 and the prosthetic valve delivery apparatus 60 to be navigated through and along, to the implantation site (e.g., the native mitral valve 16 or native mitral valve annulus).
  • the guidewire 40 is removed before inserting a dock delivery system.
  • the user may first make an incision in the patient’s body to access the vasculature 12.
  • the user may make an incision in the patient’ s groin to access a femoral vein.
  • the vasculature 12 may include a femoral vein.
  • the user may insert the guide catheter 30, the guidewire 40, and/or additional devices (e.g., an introducer device or transseptal puncture device) through the incision and into the vasculature 12.
  • the guide catheter 30 i.e., “introducer device,” “introducer,” or “guide sheath” can be configured to facilitate the percutaneous introduction of various implant delivery devices (e.g., the docking device delivery apparatus 50 and the prosthetic valve delivery apparatus 60) into and through the vasculature 12 and may extend through the vasculature 12 and into the heart 14 but may stop short of the native mitral valve 16.
  • the guide catheter 30 can comprise a handle 32 and a shaft 34 extending distally from the handle 32.
  • the shaft 34 can extend through the vasculature 12 and into the heart 14 while the handle 32 can remain outside the body of the patient 10 and can be operated by the user in order to manipulate the shaft 34 (FIG. 2A).
  • a transseptal puncture device or catheter can be used to initially access the left atrium 18, prior to inserting the guidewire 40 and the guide catheter 30.
  • the user may insert a transseptal puncture device through the incision and into the vasculature 12.
  • the user may guide the transseptal puncture device through the vasculature 12 and into the heart 14 (e.g., through the femoral vein and into the right atrium 20).
  • the user can then make a small incision in an atrial septum 22 of the heart 14 to allow access to the left atrium 18 from the right atrium 20.
  • the user can then insert and advance the guidewire 40 through the transseptal puncture device within the vasculature 12 and through the incision in the atrial septum 22 into the left atrium 18.
  • the transseptal puncture device can be removed from the patient 10.
  • the user can then insert the guide catheter 30 into the vasculature 12 and advance the guide catheter 30 into the left atrium 18 over the guide wire 40 (FIG. 2 A).
  • an introducer device can be inserted through a lumen of the guide catheter 30 prior to inserting the guide catheter 30 into the vasculature 12.
  • the introducer device can include a tapered end that extends out a distal tip of the guide catheter 30 and that is configured to guide the guide catheter 30 into the left atrium 18 over the guide wire 40.
  • the introducer device can include a proximal end portion that extends out a proximal end of the guide catheter 30.
  • FIG. 2B depicts a second stage in the exemplary mitral valve replacement procedure where a docking device 52 can be implanted at the native mitral valve 16 of the heart 14 of the patient 10 using a docking device delivery apparatus 50 (i.e., “implant catheter,” or a “docking device delivery device,” or simply “delivery apparatus”).
  • a docking device delivery apparatus 50 i.e., “implant catheter,” or a “docking device delivery device,” or simply “delivery apparatus”.
  • the docking device delivery apparatus 50 can include a delivery shaft 54 (i.e., as an “outer shaft”), a handle 56, and a pusher assembly 58 (i.e., “pusher shaft”).
  • the delivery shaft 54 can be configured to be advanced through the patient’s vasculature 12 and to the implantation site (e.g., native mitral valve 16) by the user, and may be configured to retain the docking device 52 in a distal end portion 53 of the delivery shaft 54.
  • the distal end portion 53 of the delivery shaft 54 can retain the docking device 52 therein in a substantially straight delivery orientation.
  • the handle 56 of the docking device delivery apparatus 50 can be configured to be gripped and/or otherwise held by the user to advance the delivery shaft 54 through the patient’s vasculature 12.
  • the handle 56 can be coupled to a proximal end of the delivery shaft 54 and can be configured to remain accessible to the user (e.g., outside the body of the patient 10) during the docking device implantation procedure. In this way, the user can advance the delivery shaft 54 through the patient’s vasculature 12 by exerting a force on (e.g., pushing) the handle 56.
  • the delivery shaft 54 can be configured to carry the pusher assembly 58 and/or the docking device 52 with it as it advances through the patient’s vasculature 12.
  • the docking device 52 and/or the pusher assembly 58 can advance through the patient’s vasculature 12 in lockstep with the delivery shaft 54 as the user grips the handle 56 and pushes the delivery shaft 54 deeper into the patient’s vasculature 12.
  • the handle 56 can comprise one or more articulation members 57 that are configured to aid in navigating the delivery shaft 54 through the vasculature 12.
  • the one or more articulation members 57 can comprise one or more of knobs, buttons, wheels, and/or other types of physically adjustable control members that are configured to be adjusted by the user to flex, bend, twist, turn, and/or otherwise articulate a distal end portion 53 of the delivery shaft 54 to aid in navigating the deliver ⁇ ' shaft 54 through the vasculature 12 and/or within the heart 14.
  • the pusher assembly 58 can be configured to deploy and/or implant the docking device 52 at the implantation site (e.g., the native mitral valve 16).
  • the pusher assembly 58 can be configured to be adjusted by the user to push the docking device 52 out of the distal end portion 53 of the delivery shaft 54.
  • a pusher shaft of the pusher assembly 58 can extend through the delivery shaft 54 and can be disposed adjacent to the docking device 52 within the delivery shaft 54.
  • the docking device 52 can be releasably coupled to the pusher shaft of the pusher assembly 58 via a connection mechanism of the docking device deliver ⁇ ' apparatus 50 such that the docking device 52 can be released after being deployed at the native mitral valve 16.
  • the pusher assembly 58 can also include a sleeve shaft.
  • the pusher shaft can be configured to advance the docking device 52 through the delivery shaft 54 and out of the distal end portion 53 of the delivery shaft 54, while the sleeve shaft, when included, can have a distal dock sleeve configured to cover the docking device 52 within the delivery shaft 54 and while pushing the docking device 52 out of the delivery shaft 54 and positioning the docking device 52 at the implantation site.
  • the pusher shaft can be covered, at least in part, by the sleeve shaft.
  • the pusher assembly 58 can comprise a pusher handle that is coupled to the pusher shaft and that is configured to be gripped and pushed by the user to translate the pusher shaft axially relative to the delivery shaft 54 (e.g., to push the pusher shaft into and/or out of the distal end portion 53 of the delivery shaft 54).
  • the dock sleeve can be configured to be retracted and/or withdrawn from the docking device 52, after positioning the docking device 52 at the target implantation site.
  • the pusher assembly 58 can include a sleeve handle that is coupled to the sleeve shaft and is configured to be pulled by a user to retract (e.g., axially move) the sleeve shaft relative to the pusher shaft, thereby retracting the dock sleeve.
  • a sleeve handle that is coupled to the sleeve shaft and is configured to be pulled by a user to retract (e.g., axially move) the sleeve shaft relative to the pusher shaft, thereby retracting the dock sleeve.
  • the pusher assembly 58 can be removably coupled to the docking device 52, and as such can be configured to release, detach, decouple, and/or otherwise disconnect from the docking device 52 once the docking device 52 has been deployed at the target implantation site.
  • the pusher assembly 58 may be removably coupled to the docking device 52 via a thread, string, yarn, suture, or other suitable material that is tied or sutured to the docking device 52.
  • a suture is threaded through an eyelet of the docking device 52 and tied off at a suture lock.
  • the pusher assembly 58 can include a suture lock assembly (i.e., “suture lock”) that is configured to receive and/or hold the thread or other suitable material that is coupled to the docking device 52 via a suture.
  • the thread or other suitable material that forms the suture can extend from the docking device 52, through the pusher assembly 58, to the suture lock assembly.
  • the suture lock assembly can also be configured to cut the suture to release, detach, decouple, and/or otherwise disconnect the docking device 52 from the pusher assembly 58.
  • the suture lock assembly can comprise a cutting mechanism that is configured to be adjusted by the user to cut the suture.
  • the suture lock assembly can be configured to be detached from the delivery system to give access to the sutures so the user can manually cut and remove the suture to release the docking device 52.
  • the user may insert the docking device delivery apparatus 50 (e.g., the delivery shaft 54) into the patient 10 by advancing the delivery shaft 54 of the docking device delivery apparatus 50 through the guide catheter 30.
  • the guidewire 40 can be at least partially retracted away from the left atrium 18 and into the guide catheter 30.
  • the user may then continue to advance the delivery shaft 54 of the docking device delivery apparatus 50 through the vasculature 12 along the guidewire 40 until the deliver ⁇ ' shaft 54 reaches the left atrium 18, as illustrated in FIG. 2B.
  • the user may advance the delivery shaft 54 of the docking device delivery apparatus 50 by gripping and exerting a force on (e.g., pushing) the handle 56 of the docking device delivery apparatus 50 toward the patient 10. While advancing the delivery shaft 54 through the vasculature 12 and the heart 14, the user may adjust the one or more articulation members 57 of the handle 56 to navigate the various turns, corners, constrictions, and/or other obstacles in the vasculature 12 and the heart 14.
  • the user can position the distal end portion 53 of the delivery shaft 54 at and/or near the posteromedial commissure of the native mitral valve 16 using the handle 56 (e.g., the articulation members 57). The user may then push the docking device 52 out of the distal end portion 53 of the delivery shaft 54 with the shaft of the pusher assembly 58 to deploy and/or implant the docking device 52 within the annulus of the native mitral valve 16.
  • the docking device 52 may be constructed from, formed of, and/or comprise a shape memory material, and as such, may return to its original, preformed shape when it exits the delivery shaft 54 and is no longer constrained by the delivery shaft 54.
  • the docking device 52 may originally be formed as a coil, and thus may wrap around leaflets 24 of the native mitral valve 16 as it exits the delivery shaft 54 and returns to its original coiled configuration.
  • the user may then deploy the remaining portion of the docking device 52 (e.g., an atrial portion of the docking device 52 having the brim feature) from the delivery shaft 54 within the left atrium 18 by retracting the delivery shaft 54 away from the medial commissure of the native mitral valve 16.
  • the remaining portion of the docking device 52 e.g., an atrial portion of the docking device 52 having the brim feature
  • the user can maintain the position of the pusher assembly 58 (e.g., by exerting a holding and/or pushing force on the pusher shaft) while retracting the delivery shaft 54 proximally so that the delivery shaft 54 withdraws and/or otherwise retracts relative to the docking device 52 and the pusher assembly 58.
  • the pusher assembly 58 can hold the docking device 52 in place while the user retracts the delivery shaft 54, thereby releasing the docking device 52 from the delivery shaft 54.
  • the user can also remove the dock sleeve from the docking device 52, for example, by retracting the sleeve shaft.
  • the compressible plug feature that is described in more detail below can help facilitate retention of the docking device in the native mitral valve 16 and avoid PVL.
  • the user may disconnect the docking device delivery apparatus 50 from the docking device 52. Once the docking device 52 is disconnected from the docking device deliver ⁇ ' apparatus 50 (e.g., by cutting the suture tied to the docking device 52), the user may retract the docking device delivery apparatus 50 out of the vasculature 12 and away from the patient 10 so that the user can deliver and implant a prosthetic heart valve 62 within the implanted docking device 52 at the native mitral valve 16.
  • FIG. 3A depicts a third stage in the mitral valve replacement procedure, where the docking device 52 has been fully deployed and implanted at the native mitral valve 16 and the docking device delivery apparatus 50 (including the delivery shaft 54) has been removed from the patient 10 such that only the guide wire 40 and the guide catheter 30 remain inside the patient 10.
  • the guidewire 40 can be advanced out of the guide catheter 30, through the implanted docking device 52 at the native mitral valve 16, and into the left ventricle 26 (FIG. 2B).
  • the guide wire 40 can help to guide the prosthetic valve deliver ⁇ ' apparatus 60 through the annulus of the native mitral valve 16 and at least partially into the left ventricle 26.
  • the docking device 52 can comprise a plurality of helical turns that wrap around the leaflets 24 of the native mitral valve 16 (e.g., within the left ventricle 26).
  • the implanted docking device 52 can have a more cylindrical shape than the annulus of the native mitral valve 16, thereby providing a geometry that more closely matches the shape or profile of the THV to be implanted.
  • the docking device 52 with the compressible plug can provide a tighter fit, and thus a better seal, between the prosthetic heart valve and the native mitral valve 16 to inhibit PVL at the medial commissure, as described further below.
  • FIG. 3B depicts a fourth stage in the mitral valve replacement procedure where the user is delivering and/or implanting a prosthetic heart valve 62 within the docking device 52 using a prosthetic valve delivery apparatus 60.
  • the prosthetic valve delivery apparatus 60 can comprise a delivery shaft 64 and a handle 66.
  • the delivery shaft 64 can extend distally from the handle 66.
  • the delivery shaft 64 can be configured to extend into the patient’s vasculature 12 to deliver, implant, expand, and/or otherwise deploy the prosthetic heart valve 62 within the docking device 52 at the native mitral valve 16.
  • the handle 66 can be configured to be gripped and/or otherwise held by the user to advance the delivery shaft 64 through the patient’s vasculature 12.
  • the handle 66 can comprise one or more articulation members 68 that are configured to aid in navigating the delivery shaft 64 through the vasculature 12 and the heart 14.
  • the articulation members 68 can comprise one or more of knobs, buttons, wheels, and/or other types of physically adjustable control members that are configured to be adjusted by the user to flex, bend, twist, turn, and/or otherwise articulate a distal end portion of the delivery shaft 64 to aid in navigating the delivery shaft 64 through the vasculature 12 and into the left atrium 18 and left ventricle 26 of the heart 14.
  • the prosthetic valve delivery apparatus 60 can include an expansion mechanism 65 that is configured to radially expand and deploy the prosthetic heart valve 62 at the implantation site.
  • the expansion mechanism 65 can comprise an inflatable balloon that is configured to be inflated to radially expand the prosthetic heart valve 62 within the docking device 52.
  • the inflatable balloon can be coupled to the distal end portion of the delivery shaft 64.
  • the prosthetic heart valve 62 can be self-expanding and can be configured to radially expand on its own upon removable of a sheath or capsule covering the radially compressed prosthetic heart valve 62 on the distal end portion of the deliver ⁇ ' shaft 64.
  • the prosthetic heart valve 62 can be mechanically expandable and the prosthetic valve delivery apparatus 60 can include one or more mechanical actuators (e.g., the expansion mechanism) configured to radially expand the prosthetic heart valve 62.
  • the prosthetic heart valve 62 can be mounted around the expansion mechanism 65 (e.g., the inflatable balloon) on the distal end portion of the delivery shaft 64, in a radially compressed configuration.
  • the user can insert the prosthetic valve delivery apparatus 60 (e.g., the delivery shaft 64) into the patient 10 through the guide catheter 30 and over the guidewire 40.
  • the user can continue to advance the prosthetic valve delivery apparatus 60 along the guidewire 40 (e.g., through the vasculature 12) until the distal end portion of the delivery shaft 64 reaches the native mitral valve 16, as illustrated in FIG. 3B. More specifically, the user can advance the delivery shaft 64 of the prosthetic valve deliver ⁇ ' apparatus 60 by gripping and exerting a force on (e.g., pushing) the handle 66.
  • the user can adjust the one or more articulation members 68 of the handle 66 to navigate the various turns, comers, constrictions, and/or other obstacles in the vasculature 12 and heart 14.
  • the user can advance the delivery shaft 64 along the guidewire 40 until the radially compressed prosthetic heart valve 62 mounted around the distal end portion of the deliver ⁇ ' shaft 64 is positioned within the docking device 52 and the native mitral valve 16.
  • a distal end of the delivery shaft 64 and a least a portion of the radially compressed prosthetic heart valve 62 can be positioned within the left ventricle 26.
  • the user can manipulate one or more actuation mechanisms of the handle 66 of the prosthetic valve delivery apparatus 60 to actuate the expansion mechanism 65 (e.g., inflate the inflatable balloon), thereby radially expanding the prosthetic heart valve 62 within the docking device 52.
  • the user can lock the prosthetic heart valve 62 in its fully expanded position (e.g., with a locking mechanism) to prevent the prosthetic heart valve 62 from collapsing.
  • FIG. 4A shows a fifth stage in the mitral valve replacement procedure where the prosthetic heart valve 62 in its radially expanded configuration and implanted within the docking device 52 in the native mitral valve 16. As shown in FIG. 4A, the prosthetic heart valve 62 can be received and retained within the docking device 52.
  • the prosthetic valve delivery apparatus 60 (e.g., including the delivery shaft 64) can be removed from the patient 10 such that only the guide wire 40 and the guide catheter 30 remain inside the patient 10.
  • FIG. 4B depicts a sixth stage in the mitral valve replacement procedure, where the guidewire 40 and the guide catheter 30 have been removed from the patient 10.
  • the docking device 52 with a compressible plug and optionally a brim feature can be configured to provide a seal between the prosthetic heart valve 62 and the leaflets 24 of the native mitral valve 16 to reduce paravalvular leakage around the prosthetic heart valve 62.
  • the compressible plug can be configured for plugging the medial commissure to inhibit any leakage from the area.
  • the docking device 52 can initially constrict the leaflets 24 of the native mitral valve 16, where the brim feature sits on top on the left atrial side and the compressible plug fits on or into the medial commissure.
  • the prosthetic heart valve 62 can then push the leaflets 24 against the docking device 52 as it radially expands within the docking device 52.
  • the docking device 52 and the prosthetic heart valve 62 can be configured to sandwich the leaflets 24 of the native mitral valve 16 when the prosthetic heart valve 62 is expanded within the docking device 52.
  • the docking device 52 can provide a seal between the leaflets 24 of the native mitral valve 16 and the prosthetic heart valve 62 to reduce paravalvular leakage around the prosthetic heart valve 62, especially with the medial commissure being plugged by the compressible plug.
  • one or more of the docking device delivery apparatus 50, the prosthetic valve delivery apparatus 60, and/or the guide catheter 30 can comprise one or more fluid ports that are configured to supply flushing fluid to the lumens thereof to prevent and/or reduce the likelihood of blood clot (e.g., thrombus) formation.
  • Example fluid ports that can be used to inject flushing fluid into a docking device delivery apparatus are described further below.
  • FIGS. 2A-4B specifically depict a mitral valve replacement procedure
  • the same and/or similar procedure may be utilized to replace other heart valves (e.g., tricuspid, pulmonary, and/or aortic valves).
  • the same and/or similar delivery apparatuses e.g., docking device delivery apparatus 50, prosthetic valve delivery apparatus 60, guide catheter 30, and/or guidewire 40
  • docking devices e.g., docking device 52
  • replacement heart valves e.g., prosthetic heart valve 62
  • components thereof may be utilized for replacing these other heart valves.
  • the user when replacing a native tricuspid valve, the user may also access the right atrium 20 via a femoral vein but may not need to cross the atrial septum 22 into the left atrium 18. Instead, the user may leave the guidewire 40 in the right atrium 20 and perform the same and/or similar docking device implantation process at the tricuspid valve. Specifically, the user may push the docking device 52 out of the delivery shaft 54 around the ventricular side of the tricuspid valve leaflets, release the remaining portion of the docking device 52 from the delivery shaft 54 within the right atrium 20, and then remove the delivery shaft 54 of the docking device delivery apparatus 50 from the patient 10.
  • the user may then advance the guidewire 40 through the tricuspid valve into the right ventricle and perform the same and/or similar prosthetic heart valve implantation process at the tricuspid valve, within the docking device 52.
  • the user may advance the delivery shaft 64 of the prosthetic valve delivery apparatus 60 through the patient’s vasculature along the guidewire 40 until the prosthetic heart valve 62 is positioned or disposed within the docking device 52 and the tricuspid valve.
  • the user may then expand the prosthetic heart valve 62 within the docking device 52 before removing the prosthetic valve delivery apparatus 60 from the patient 10.
  • the user may perform the same and/or similar process to replace the aortic valve but may access the aortic valve from the outflow side of the aortic valve via a femoral artery.
  • FIGS. 2A-4B depict a mitral valve replacement procedure that accesses the native mitral valve 16 from the left atrium 18 via the right atrium 20 and femoral vein
  • the native mitral valve 16 may alternatively be accessed from the left ventricle 26.
  • the user may access the native mitral valve 16 from the left ventricle 26 via the aortic valve by advancing one or more deliver ⁇ ' apparatuses through an artery to the aortic valve, and then through the aortic valve into the left ventricle 26.
  • the prosthetic heart valves comprises a plastically expandable material, which can be metal alloys, polymers, or combinations thereof.
  • Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal.
  • the prosthetic heart valve can comprise stainless steel, cobalt-chromium, nickel-cobalt-chromium, a nickel-cobalt- chromium-molybdenum alloy, such as MP35NTM (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02).
  • MP35NTM/UNS R3OO35 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.
  • the prosthetic heart valve can be a self-expandable prosthetic valve with a frame made from a self-expanding material, such as nickel-titanium alloy or Nitinol.
  • a self-expanding valve the balloon of the deliver ⁇ ' apparatus can be replaced with a sheath or similar restraining device that retains the prosthetic valve in a radially compressed state for delivery through the body.
  • the prosthetic valve is at the implantation location, the prosthetic valve can be released from the sheath, and therefore allowed to expand to its functional size.
  • any of the delivery apparatuses disclosed herein can be adapted for use with a selfexpanding valve.
  • Docking devices can, for example, provide a stable anchoring site, landing zone, or implantation zone at the implant site in which prosthetic valves can be expanded or otherwise implanted.
  • Many of the disclosed docking devices comprise a circular or cylindrically-shaped portion, which can (for example) allow a prosthetic heart valve comprising a circular or cylindrically-shaped valve frame to be expanded or otherwise implanted into native locations with naturally circular cross- sectional profiles and/or in native locations with naturally non-circular cross sections.
  • the docking devices can be sized and shaped to cinch or draw the native valve (e.g., mitral, tricuspid, etc.) anatomy radially inwards.
  • valve regurgitation e.g., functional mitral regurgitation
  • enlargement of the heart e.g., enlargement of the left ventricle, etc.
  • valve annulus e.g., enlargement of the left ventricle, etc.
  • stretching out of the native valve e.g., mitral, etc.
  • the docking devices further include features which, for example, are shaped and/or modified to better hold a position or shape of the docking device during and/or after expansion of a prosthetic valve therein.
  • FIGS. 5A-5C show example compressible plug scaffolds 200 for use as a medial commissure compressible plug 210.
  • the compressible plug 210 includes the scaffold and a plugging component (not shown, such as a cover, inner bladder, absorbable members, compressible hydrophobic members, etc.) that inhibit fluid from passing the compressible plug from the medial commissure.
  • a plugging component not shown, such as a cover, inner bladder, absorbable members, compressible hydrophobic members, etc.
  • FIGS. 5A-5C would further include such a plugging component for use, but are shown as only the compressible plug scaffold to illustrate its shape-memory features.
  • FIG. 5A includes a side view that shows an embodiment of a compressible plug scaffold 200 that is shaped as a tube.
  • the compressible plug scaffold 200 is illustrated to show one side for clarity, however, the illustrated compressible plug scaffold 200 is a three-dimensional body having a tubular shape with a single layer to form a lumen therein.
  • the three-dimensional body is shaped as a mesh scaffold that is formed of one or more wires 204 that are formed of a shape-memory material to define the apertures 206. This allows for the compressible plug scaffold 200 to be formed into a desired compressible shape for shape-memory return.
  • the compressible shape has an internal space with volume, that when compressed closes the shape to be substantially tubular and elongated without any internal space or internal volume.
  • the wires 204 are formed so that they can be formed into the shape-memory compressible shape and then compressed to conform with whatever shape is being defined by the compression.
  • a catheter delivery device can have a tubular lumen for receiving an implantable medical device, such as a docking station.
  • the wires 204 are formed so that the compressible plug scaffold 200 can be deformed into a tubular, cylindrical, shorted or elongated in some direction to overall compress the scaffold 202 into a tubular lumen, and often to be a layer around a coil in a tubular lumen.
  • FIG. 5 A shows an elongate tubular shape for the mesh scaffold 202.
  • the wires 204 are arranged into the mesh scaffold 202 to form apertures 206.
  • the shape in FIG. 5A can be used as a compressible plug, or it can be shaped into a bulbous or spherical/rounded shape with or without a tapered end.
  • FIG. 5A shows the tubular form that can be operably coupled with the plugging component to form a PVL-inhibiting compressible Plug.
  • FIG. 5B illustrates an embodiment of a compressible plug having the compressible plug scaffold 200 formed by the mesh scaffold 202 with the shape-memory wires 204 to define the apertures 206 between the wires 204.
  • the mesh scaffold 202 includes two flared ends 212 and a narrowed body. This embodiment can be used as described herein as a compressible plug. Additionally, this embodiment can be turned halfway inside out to form a shape that is half of FIG. 5B as shown at the dashed line, which has a double layer of the mesh scaffold 202.
  • FIG. 5C illustrates another embodiment of a compressible plug having the compressible plug scaffold 200 formed by the mesh scaffold 202 with the shape-memory wires 204 to define apertures between the wires 204.
  • the mesh scaffold 202 is formed into a bulbous shape that has a base end 214, a tubular region 215, a tapered region 216, and a flared end 212.
  • the mesh scaffold 202 is double layered with an outer shell 218 and inner core 220 with a volume of space therebetween.
  • the inner core 220 also forms an inner conduit 222, which can be a lumen for receiving the coil of the docking station therethrough.
  • the mesh scaffold 202 is shown to include a first opening 222a at the base end and a second opening 222b at the flared end 212. These openings can be curved, such as a partial toroidal shape. The ends can bend around as allowed by the flexibility of the wires 204 to allow for different shapes to be formed.
  • the compressible plug scaffold 200 can be coupled with a plugging component in order to be configured as a compressible plug.
  • FIG. 6A illustrates a top view of an example embodiment of a hybrid docking device 70 or a coil of a hybrid docking device 70 in accordance with various embodiments.
  • the docking device 70 can be configured to fit at the mitral position but can be shaped and/or adapted similarly or differently in other embodiments for better accommodation at other native valve positions as well, such as at the tricuspid valve.
  • the docking device geometries of the present disclosure provide for engagement with the native anatomy that can provide for increased stability and reduction of relative motion between the docking device 70, the prosthetic valve docked therein, and the native anatomy. Reduction of such relative motion can prevent material degradation of components of the docking device and/or the prosthetic valve docked therein and can prevent damage/trauma to the native tissues as well as preventing PVL, such as through the medial commissure.
  • the docking device 70 of many embodiments includes a central region 80 with a coil, coiled portion, or multiple coils (e.g., 2 coils, 3 coils, 4 coils, between 2-5 coils, or more).
  • the coiled portion or coils of the central region 80 can be similarly sized and shaped or vary in size and/or shape.
  • the central region 80 comprises three or approximately three full coil turns having substantially equal inner diameters.
  • the central region 80 of the docking device 70 serves as the main landing region or holding region for holding the expandable prosthetic valve when the docking device 70 and the valve prosthesis are implanted into a patient’s body.
  • the docking device 70 has a central region 80 with more or less than three coil turns, depending for example, on the patient’s anatomy, the amount of vertical contact desired between the docking device 70 and the valve prosthesis (e.g., transcatheter heart valve or THV), and/or other factors.
  • the coiled portion or coil(s) of the central region 80 can also be referred to as the “functional coils” or “functional turns” since the properties of these coils contribute the most to the amount of retention force generated between the valve prosthesis, the docking device 70, and the native mitral leaflets and/or other anatomical structures.
  • a main factor is the number of turns included in the functional coils, while other factors include, for example, an inner diameter of the functional coils, friction force (e.g., between the coils and the prosthetic valve), and the strength of the prosthetic valve and the radial force the valve applies on the coil.
  • a docking device can have a variety of numbers of coils and/or coil turns. The number of functional turns can be in ranges from just over a half turn to 5 turns, or one full turn to 5 turns, or more. In one embodiment with three full turns, an additional one-half turn is included in the ventricular portion of the docking device. In another embodiment, there can be three full turns total in the docking device.
  • the atrial portion of the docking device there can be one-half to three-fourths turn or one -half to three- fourths of a circle. While a range of turns is provided, as the number of turns in a docking device is decreased, the dimensions and/or materials of the coil and/or the wire that the coil is made from can also change to maintain a proper retention force. For example, the diameter of the wire can be larger and/or the diameter of the functional coil turn(s) in a docking device with fewer coils. There can be a plurality of coils in the atrium and in the ventricle.
  • a size of the functional coils or coils of the central region 80 is generally selected based on the size of the desired THV to be implanted into the patient.
  • the inner diameter 90 of the functional coils/turns e.g., of the coils/tums of the central region 80 of the docking device 70
  • the retention force needed for adequate implantation of a prosthetic valve varies based on the size of the prosthetic valve and on the ability of the assembly to handle mitral pressures of approximately 180 mm Hg.
  • a retention force of at least 15.8 N can be needed between the docking device and the prosthetic valve in order to securely hold the prosthetic valve in the docking device and to resist or prevent valve regurgitation or leakage.
  • a target average retention force should be substantially greater, for example, approximately 30 N.
  • the inner diameter of the functional coils (e.g., the coils of the central region of docking device 1) should be 24 mm or less.
  • the inner diameter of the functional coils (e.g., central region 80 of the docking device 70) should be selected to be at least about 5 mm less than the prosthetic valve that is selected for implantation, though other features and/or characteristics (e.g., friction enhancing features, material characteristics, etc.) can be used to provide better retention if other sizes or size ranges are used, as various factors can affect retention force.
  • the desired retention forces discussed above are applicable to embodiments for mitral valve replacements. Therefore, other embodiments of the docking device that are used for replacement of other valves can have different size relationships based on the desired retention forces for valve replacement at those respective positions.
  • the size differentials can also vary, for example, based on the materials used for the valve and/or the docking device, whether there are any other features to prevent expansion of the functional coils or to enhance friction/locking, and/or based on various other factors.
  • the docking device 70 can first be advanced and delivered to the native mitral valve annulus, and then set at a desired position, prior to implantation of the prosthetic heart valve.
  • the docking device 70 is flexible and/or made of a shape memory material, so that the coils of the docking device 70 can be straightened for delivery via a transcatheter approach as well.
  • the coil is made of another biocompatible material, such as stainless steel.
  • the central region 80 of the docking device 70 are kept relatively small in diameter (e.g., the central region 80 in one embodiment can have an inner diameter of between approximately 21-24 mm (e.g., ⁇ 2 mm) or another diameter smaller than the prosthetic valve and/or the native annulus) in order to increase retention force with the prosthetic valve, it might be difficult to advance the docking device 70 around the existing leaflets and/or chordae tendineae to a desired position relative to the native mitral annulus. This is especially true if the entire docking device 70 is made to have the same small diameter as the central region 80.
  • the docking device 70 can have a distal or lower region 82 that comprises and/or consists of a leading coil/tum (sometimes referred to as an encircling turn or a leading ventricular coil/tum) of the docking device 70, which has a lower diameter that is greater than the diameter of the functional coils/tums or of the coils/turns of central region 80.
  • a leading coil/tum sometimes referred to as an encircling turn or a leading ventricular coil/tum
  • native mitral anatomy can have an approximately 35 mm to 45 mm greatest width on a long axis.
  • the diameter or width of the encircling turn or leading coil/turn (e.g., ventricular coil/turn) of the lower region 82 can be selected to be larger to more easily navigate a distal or leading tip 84 of the docking device 70 around and encircle the features of the native anatomy (e.g., leaflets and/or chordae tendineae).
  • the diameter could be any size from 25 mm to 75 mm.
  • the term “diameter” as used in this disclosure does not require that a coil/tum be a complete or perfectly-shaped circle but is generally used to refer to a greatest width across opposing points of the coil/tum.
  • diameter can be measured from the distal tip 84 to the opposite side, as if the lower region 82 or leading coil/turn formed a complete rotation.
  • the docking device 70 can also include an enlarged proximal or upper region 86 that comprises and/or consists of a stabilizing coil/turn (e.g., which can be an atrial coil/tum) of the docking device 70.
  • a stabilizing coil/turn e.g., which can be an atrial coil/tum
  • the coil could be shifted and/or dislodged from its desired position or orientation, for example, by regular heart function. Shifting of the docking device 70 could potentially lead to a less secure implantation, misalignment, and/or other positioning issues for the prosthetic valve.
  • a stabilization feature or coil can be used to help stabilize the docking device 70 in the desired position.
  • the docking device 70 can include the upper region 86 with an enlarged stabilization coil/turn (e.g., an enlarged atrial coil/tum having a greater diameter 92 and/or 94 than the functional coils) intended to be positioned in the circulatory system (e.g. in the left atrium) such that it can stabilize the docking device.
  • the upper region 86 or stabilization coil/tum can be configured to abut or push against the walls of the circulatory system (e.g., against the walls of the left atrium), in order to improve the ability of the docking device 70 to stay in its desired position prior to the implantation of the prosthetic valve.
  • the radial size of the stabilization coil/turn (e.g., atrial coil) at the upper region 86 can also be significantly larger than the size of the functional coils in the central region 80, so that the stabilization coil/tum (e.g., atrial coil or atrial turn) flares or extends sufficiently outwardly in order to contact the walls of the circulatory system (e.g., the walls of the left atrium).
  • the stabilization coil/turn of various embodiments will be configured to be less abrasive to the native tissue and/or anatomy.
  • the surface texture can be made smoother and/or softer, such that movement of the docking device 70 against the native anatomy will not damage the native tissue.
  • the coil 102 can be at least partially surrounded by a cover.
  • the cover can, for example, prevent or reduce trauma to native tissue and/or prevent or reduce damage to the delivery device, reduce friction with the native tissue, increase friction with the native tissue and/or prosthetic heart valve, etc.
  • the coil 102 can comprise a plurality of covers and/or a plurality of sections of one or more covers, each configured for a particular purpose.
  • a first cover can be provided over all or at least substantially all of the coil 102, for example, to prevent or reduce trauma to the native tissue.
  • a second cover can extend over a portion of the first cover and can, for example, be configured to increase friction between the cover and native leaflet tissue.
  • This cover can be used to couple the guard member 104 to the coil.
  • material of the guard member 104 can be coupled to material of the cover, such as by adhesive, stitching, loop stitching, or other coupling.
  • the cover can be external or internal. When internal, the cover can function similar to a bladder, which covers the scaffold from the inside.
  • the core 102a of the coil 102 can be surrounded by an inner cover 112 (which can also be referred to as “a first cover”).
  • the core 102a of the coil 102 is the structural part of the coil 102, which can be referred to as the core 102a.
  • the inner cover 112 can have a tubular shape.
  • the inner cover 112 can cover an entire length of the core 102a of the coil 102.
  • the inner cover 112 covers only selected portion(s) of the core 102a of the coil 102.
  • FIGS. 6B-6C show the core 102a.
  • the inner cover 112 can be coated on and/or bonded on the core 102a of the coil 102. In some examples, the inner cover 112 can be a cushioned, padded- type layer protecting the core 102a of the coil 102.
  • the inner cover 112 can be constructed of various natural and/or synthetic materials. In one particular example, the inner cover 112 can include a foam material (e.g., expanded polytetrafluoroethylene (ePTFE)).
  • ePTFE expanded polytetrafluoroethylene
  • the inner cover 112 is configured to be fixedly attached to the core 102a of the coil 102 (for example, by means of textured surface resistance, suture, glue, thermal bonding, or any other means) so that relative axial movement between the inner cover 112 and the core 102a of the coil 102 is restricted or prohibited.
  • one or more portions of the inner cover 112 e.g., a distal end portion
  • one or more other portions of the inner cover e.g., an intermediate portion and/or a proximal end portion
  • the inner cover 112 is coupled with the flap sheet 150 of the guard member 104.
  • the docking device 70 can also include a retention member 114 (which may also be referred to as “a second cover” or “an outer cover”) surrounding at least a portion of the inner cover 112 (and the core 102a of the coil 102).
  • the retention member 114 can extend over the entire length of the inner cover 112.
  • the retention member 114 extends over only a portion of the inner cover 112 so that one or more portions of the inner cover 112 (e.g., the proximal and/or distal end portions) are exposed.
  • a proximal end of the retention member 114 can be positioned proximal to a proximal end of the guard member 104.
  • the proximal end of the retention member 114 can be disposed at or adjacent the ascending portion 110b of the coil 102.
  • a distal end of the retention member 114 can be positioned distal to a distal end of the guard member 104.
  • the distal end of the retention member 114 can be positioned adjacent the leading turn 106.
  • the retention member 114 can cover the functional turns of the coil 102 in the central region 108.
  • the retention member 114 does not cover the guard member 104.
  • the retention member 114 can be coupled to the guard member 104, such as by being coupled with the flap sheet 150.
  • the retention member 114 can be formed of various materials configured to engage the native tissue and/or prosthetic heart valve to increase friction therebetween and/or promote tissue ingrown.
  • the retention member 114 can comprise a biocompatible fabric material (e.g., polyethylene terephthalate (PET)).
  • PET polyethylene terephthalate
  • the retention member 114 can comprise a braided material.
  • the retention member 114 can include a woven material.
  • the guard member 104 can be fixedly attached to the retention member 114 and/or the inner cover 112, for example, via a guard attachment such as sutures, adhesive, and/or any other suitable means for attaching.
  • FIGS. 6D-6E illustrate a compressible plug 210 (described herein, FIGS. 5A-5C) that attaches to the coil 102 of the docking device 70 of FIG. 6A.
  • FIG. 6D includes a top view that shows the docking station 70 having the coil 102 attached to the compressible plug 210.
  • the coil 102 passes through the inner conduit 222 of the compressible plug 210.
  • the compressible plug 210 includes a cover as the plugging component.
  • the cover can be porous or fluid tight depending on different embodiments, such as woven, braided, knitted, or other cloth or expanded materials (ePTFE).
  • the porous cover can allow for cellular ingrowth, where the pores can be small enough to inhibit blood from flowing therethrough. The blood may also coagulate at the pores to provide more leak inhibition.
  • the compressible plug 210 is coupled to the coil 102 so as to be in a defined position.
  • the end of the compressible plug 210 can be sutured to a cover of the coil 102, such as shown in FIGS. 6B-6C.
  • FIG. 6E includes a side view that shows the docking station 70 with the coil 102 in the coiled shape and with the compressible plug 210 receiving the coil 102 through the inner conduit 222 and exiting the second opening 222b at the flared end 212.
  • the plug coupling 230 is shown which includes a stitching the compressible plug to the cover of the coil 102.
  • a wrapping material can be used to wrap around the plug coupling 230. While this embodiment shows the coil 102 extending through the inner conduit 222 and out the second opening 222b, the entire compressible plug 210 can be only attached at one end to hang off of the coil 102, where the coil 102 is entirely outside of the compressible plug 210.
  • the compressible plug 210 can be configured to fit at the medial commissure with respect to the mitral valve so as to provide a cover over the mitral leaflets and perimeter of the mitral valve region at the medial commissure.
  • the compressible plug 210 can be pressed onto or at least partially into the medial commissure to inhibit PVL through this region.
  • the compressible plug 210 can be shaped and/or adapted similarly or differently in other embodiments for better accommodation at other native valve positions as well, such as at the tricuspid valve, which can be configured along with the docking device 70.
  • the compressible plug 210 geometries of the present disclosure provide for engagement with the native anatomy of the medial commissure at the mitral valve that can provide for increased stability and reduction of relative motion between the docking device 70 and/or compressible plug 210 with respect to the native anatomy. Reduction of such relative motion can prevent gaps to form to allow for leakage around the compressible plug 210, and can prevent damage/trauma to the native tissues.
  • the compressible plug 210 can be configured to provide an adaptive fit to the docking device 70 to inhibit leaks at the medial commissure of the mitral valve anatomy and inhibit leakage of blood, such as inhibit PVL.
  • the shape of the compressible plug, and the number of expanded body regions of the compressible plug, as well as the length, thickness, and bulbous features of the compressible plug can be modulated for different sized anatomies, such as from children through adults, and the various sizes thereof.
  • the flexibility of the compressible plug 210 due to the flexibility of the mesh scaffold formed of the shape-memory material can contribute with shaping and contouring of the compressible plug 210 with the adjacent anatomy at the mitral valve.
  • the thickness of the compressible plug scaffold can be varied in dimension to be bigger at a bulbous end compared to the narrower base.
  • the docking device 70 with the compressible plug 210 can first be advanced and delivered to the native mitral valve annulus, and then set at a desired position with the compressible plug 210 covering the mitral leaflets and perimeter anatomy at the medial commissure, prior to implantation of the prosthetic heart valve.
  • the compressible plug 210 is flexible and/or made of a shape memory material, so that the wires conform with the shape of the coil of the docking device 70 and can be straightened for delivery via a transcatheter approach as well.
  • the compressible plug scaffold is made of shape memory material (e.g., nitinol) or another biocompatible material, such as stainless steel.
  • the coil 102 can include a material that can be coupled with the material of the compressible plug 210, such as be sewing, stitching, suturing, brazing, welding, adhesive, clipping, clamping, crimping, riveting, any mechanical securement or the like.
  • the docking device 70 may include a material cover around the base coil, and the compressible plug 210 may also include a material cover that can be coupled with the cover of the coil. That is, the covers of the two components can be coupled together, such as by suturing, sewing, adhesive, clipping, or otherwise affixing the compressible plug 210 to the docking device 70, which is discussed in more detail herein.
  • the compressible plug 210 can be stitched to the coil 102 with sutures to couple to the coil 102.
  • the compressible scaffold of the compressible plug 210 can be directly coupled with the coil 102.
  • the compressible plug 210 may be formed of a tightly woven or braided material that forms a body resistant to fluids. That is, the materials described herein can be prepared into proper filaments to be woven or braided with tightness as desired.
  • the woven or braided material can have tightness that does not have any gaps or interstitial spaces between the weaves or braids.
  • the tightness of the weave and braid can range from loose with gaps to tight so as to form fluid tightness with essentially no gap or interstitial spaces.
  • the compressible scaffold itself can be a woven or braided pattern that is fluid tight.
  • Such a configuration of the compressible scaffold can be directly coupled to the coil, where the coupling can include being coupled to the core or a cover of the coil.
  • the coupling to the core or cover of the coil can be by sewing, stitching, suturing, brazing, welding, adhesive, riveting, any mechanical securement or the like.
  • the length of the compressible plug 210 can be modulated depending on the design of the docking device 70. Accordingly, the compressible plug 210 can be configured to cover a certain percentage of a full coil turn or even a full 360 degree turn or more.
  • the compressible plug 210 length can be tailored so that the length matches with the mitral valve anatomy and provides a sufficient length for the shape-memory body to expand when deployed to engage and overlap the anatomy to provide a cover.
  • the length of the compressible plug 210 can be relative to the central region 80 of the docking device 70.
  • the length of the compressible plug 210 from the base to the flared end or other end can be from about 10 mm to about 110 mm, from about 25 mm to about 100 mm, from about 40 mm to about 90 mm, from about 45 mm to about 80 mm, or about 50 mm to about 75 mm. In some embodiments, the length can be about 54 mm.
  • the plug scaffold can include a shape memory material that is shape set and/or pre-configured to expand the compressible plug 210 to the radially expanded state when unconstrained (for example, when deployed at a native valve location).
  • a scaffold 120 can contain a shape memory alloy with super-elastic properties, such as Nitinol.
  • the scaffold 120 can contain a ternary shape memory alloy with super-elastic properties, such as NiTiX where X can be chromium (Cr), cobalt (Co), zirconium (Zr), hafnium (Hf), etc.
  • the plug scaffold can comprise a metallic material that does not have the shape memory properties.
  • the plug scaffold can have a biasing mechanism (e.g., using springs, etc.) configured to bias the scaffold to the radially expanded state.
  • metallic material include cobalt-chromium, stainless steel, etc.
  • the scaffold can comprise nickel-free austenitic stainless steel in which nickel can be completely replaced by nitrogen.
  • the scaffold can comprise cobalt-chromium or cobalt-nickel-chromium- molybdenum alloy with significantly low density of titanium.
  • the cover of the plug scaffold can be configured to be so elastic that when the compressible plug 210 moves from the delivery orientation to the deployed orientation, the cover can accommodate the scaffold.
  • the shape of the compressible scaffold and cover can be cooperatively configured such that the compressible plug has an adaptable shape that can be adjusted during deployment to accommodate various anatomy shapes and sizes.
  • the scaffold and cover e.g., external cover or internal cover
  • the shape and adjustability of the compressible plug can be used to inhibit any fluid flow or leaking through the medial commissure.
  • compressing the plug can cause radial expansion that covers the leaflets (e.g., P2, P3, or portions thereof) adjacent to the medial commissure, which can be for a variety of different anatomies.
  • the plug cover can be configured to be atraumatic to native tissue and/or promote tissue ingrowth into the material of the plug cover.
  • the plug cover can have pores to encourage tissue ingrowth.
  • the plug cover can be impregnated with growth factors to stimulate or promote tissue ingrowth, such as transforming growth factor alpha (TGF-alpha), transforming growth factor beta (TGF- beta), basic fibroblast growth factor (bFGF), vascular epithelial growth factor (VEGF), and combinations thereof.
  • TGF-alpha transforming growth factor alpha
  • TGF- beta transforming growth factor beta
  • bFGF basic fibroblast growth factor
  • VEGF vascular epithelial growth factor
  • the plug cover can be constructed of any suitable material, including foam, cloth, fabric, metal, shape memory alloys, and/or polymer, which is flexible to allow for compression and expansion of the plug cover.
  • the plug cover can include a fabric layer constructed from a thermoplastic polymer material, such as polyethylene terephthalate (PET), which can be knitted, woven, or braided to form a cover.
  • PET polyethylene terephthalate
  • the plug cover can be formed of a shape-memory alloy or other metal that can be woven or braided into a fluid tight sheet.
  • nitinol can be formed into filaments that are woven or braided into a body that is substantially fluid tight or at least fluid mitigating to inhibit fluids from passing through the material.
  • the cover can also include an elastomer, such as a rubber, styrene butadiene rubber, polybutadiene rubber, polyisoprene rubber, neoprene, nitrile rubber, silicone.
  • the material of the cover may be applied via dip coating, spray coating, brush on, and other application protocols.
  • the application can provide the cover to have a certain thickness and durometer to achieve collapsibility and maintain a minimal profile when the plug is collapsed into the sleeve.
  • the cover material can also enable to plug to achieve its fully-expanded shape, while still covering all of the cells of the scaffold. This principle can be applied to an external or internal cover relative to the scaffold.
  • a separate braided mesh of one of the materials can be added to the interior open space of the plug, which braided mesh can be an internal cover.
  • This additional mesh can be made of a thinner wire and have a smaller pore size than an outer structural mesh.
  • the internal cover can then act as a flow inhibitor due to the smaller pores.
  • the plug cover can be configured to engage with the prosthetic valve deployed within the docking device so as to form a seal and reduce paravalvular leakage between the prosthetic valve and the docking device after the compressible plug 210 is radially expanded.
  • the plug cover can help inhibit PVL at the medial commissure.
  • the plug cover can also be configured to engage with the native tissue (for example, the native annulus and/or native leaflets) to reduce PVL between the docking device and/or the prosthetic valve and the native tissue.
  • the coil 102 has a proximal end 102p and a distal end 102d, with the compressible plug 210 therebetween, which also respectively define the proximal and distal ends of the docking device 70.
  • a body of the coil 102 between the proximal end 102p and the distal end 102d along with the compressible plug 210 can form the generally straight delivery orientation (that is, without any coiled or looped portions, but can be flexed or bent) so as to maintain a small radial profile when moving through a patient’s vasculature.
  • the coil 102 and compressible plug 210 can move from the delivery orientation to the helical deployed orientation with the compressible plug 210 extended laterally from the coil 102 on top of the mitral valve anatomy at the medial commissure, and with the coil 102 wrapping around native leaflet tissue adjacent the implant position.
  • the coil 102 when implanting the docking device at the location of a native valve, can be configured to surround native leaflets of the native valve (and the chordae tendineae that connects native leaflets to adjacent papillary muscles, if present) with the compressible plug 210 on top of the medial commissure or extending at least partially therethrough so as to be over where the leaflets would be, thereby the compressible plug 210 forming a plug over the medial commissure and over the mitral valve anatomy in the left atrium. Additionally, a portion of the compressible plug 210 can extend through the medial commissure so that at least a portion of the compressible plug 210 is within the left ventricle.
  • the docking device 70 can be releasably coupled to a delivery apparatus (e.g., docking device delivery apparatus 50).
  • a delivery apparatus e.g., docking device delivery apparatus 50
  • the docking device 70 can be coupled to the delivery apparatus via a release suture that can be configured to be tied to the docking device 70 and cut for removal.
  • the release suture can be tied to the docking device 70 through an eyelet or eyehole located adjacent the proximal end 102p of the coil.
  • the release suture can be tied around a circumferential recess that is located adjacent the proximal end 102p of the coil 102.
  • the coil 102 in the deployed orientation can include a leading turn 106 (or “leading coil”), a central region 108 (e.g. having the compressible plug 210), and a stabilization turn 110 (or “stabilization coil”) around the central longitudinal axis.
  • leading turn 106 may be omitted in some design embodiments.
  • the central region 108 can possess one or more helical turns having substantially equal inner diameters with one of these turns being coupled with the compressible plug 210.
  • the leading turn 106 can extend from a distal end of the central region 108 and has a diameter greater than the diameter of the central region 108 (in one or more configurations).
  • the stabilization turn 110 can extend from a proximal end of the central region 108 and has a diameter greater than the diameter of the central region 108 (in one or more configurations).
  • the diameters can be the same in other configurations.
  • the central region 108 can include a plurality of helical turns (e.g., the docking device 70 can have three helical turns in the central region 108). Some of the helical turns in the central region 108 can be full turns (that is, rotating 360 degrees). In some examples, the most proximal turn and/or the most distal turn can be partial turns (for example, rotating less than 360 degrees, such as 180 degrees, 270 degrees, etc.).
  • the compressible plug 210 can be positioned anywhere along the central region 108, and is shown at the proximal turn thereof.
  • the top-most or most proximal helical turn of the central region 108 can include the compressible plug 210 coupled thereto. This provides the compressible plug 210 in the region of the coil 102 that is in the left atrium, while the distal helical turns go into the left ventricle around the leaflets.
  • the size of the docking device 70 and compressible plug 210 can be generally selected based on the size of the desired prosthetic valve to be implanted into the patient and the size of the anatomy at the left atrium intersection with the mitral valve anatomy.
  • the central region 108 can be configured to retain a radially expandable prosthetic valve.
  • the inner diameter of the helical turns in the central region 108 can be configured to be smaller than an outer diameter of the prosthetic valve when the prosthetic valve is radially expanded so that additional radial force can act between the central region 108 and the prosthetic valve to hold the prosthetic valve in place.
  • the helical turns in the central region 108 can also be referred to herein as “functional turns.”
  • the stabilization turn 110 can be configured to help stabilize the docking device 70 in the desired position.
  • the radial dimension of the stabilization turn 110 can be significantly larger than the radial dimension of the coil in the central region 108, so that the stabilization turn 110 can flare or extend sufficiently outwardly so as to abut or push against the walls of the circulatory system, thereby improving the ability of the docking device 70 to stay in its desired position prior to the implantation of the prosthetic valve.
  • the diameter of stabilization turn 110 is desirably larger than the native annulus, native valve plane, and/or native chamber for better stabilization.
  • the stabilization turn 110 can be a full turn (that is, rotating about 360 degrees).
  • the stabilization turn 110 can be a partial turn (for example, rotating between about 180 degrees and about 270 degrees).
  • the functional turns in the central region 108 can be disposed substantially in the left ventricle and the stabilization turn 110 can be disposed substantially in the left atrium above the guard member 104.
  • the stabilization turn 110 can be configured to provide one or more points or regions of contact between the docking device 70 and the left atrial wall, such as at least three points of contact in the left atrium or complete contact on the left atrial wall opposite of the guard member contacting the left atrial wall.
  • the points of contact between the docking device 70 and the left atrial wall can form a plane that is approximately parallel to a plane of the native mitral valve, and may be parallel to a plane of the guard member 104.
  • the guard member can be configured to stabilize the docking device into the mitral valve. As such, the device can omit an atrial turn in the coil.
  • the stabilization turn 110 can have an atrial portion 110c in connection with the central region 108, a stabilization portion 110a adjacent to the proximal end 102p of the coil 102, and an ascending portion 110b located between the atrial portion 110c and the stabilization portion 110a.
  • Both the atrial portion 110c and the stabilization portion 110a can be generally parallel to the helical turns in the central region 108, whereas the ascending portion 110b can be oriented to be angular relative to the atrial portion 110c and the stabilization portion 110a.
  • the ascending portion 110b and the stabilization portion 110a can form an angle from about 45 degrees to about 90 degrees (inclusive).
  • the atrial portion 110c When implanting the docking device 70 at the native mitral valve location, the atrial portion 110c can be configured to abut against a posterior wall of the left atrium and the stabilization portion 110a can be configured to flare out and press against an anterior wall of the left atrium, along with the guard member.
  • the coil 102 can omit the stabilization turn, and the proximal region of the coil 102 can be another portion coil 102.
  • the guard member 104 provides the stabilization of the docking device with respect to the mitral valve anatomy and the left ventricle.
  • the leading turn 106 can have a larger radial dimension than the helical turns in the central region 108.
  • the leading turn 106 can help more easily guide the coil 102 around and/or through the chordae tendineae and/or adequately around all native leaflets of the native valve (for example, the native mitral valve, tricuspid valve, etc.).
  • the remaining coil (such as the functional turns) of the docking device 70 can also be guided around the same features.
  • the leading turn 106 can be a full turn (that is, rotating about 360 degrees).
  • the leading turn 106 can be a partial turn (for example, rotating between about 180 degrees and about 270 degrees).
  • the functional turns in the central region 108 can be further radially expanded.
  • the leading turn 106 can be pulled in the proximal direction and become a part of the functional turn in the central region 108.
  • the compressible plug 210 can extend along a portion (e.g., the atrial portion) of the stabilization turn 110 of the coil 102. In some examples, the compressible plug 210 can extend along at least a portion of the central region 108 of the coil 102 (e.g., a portion of the most proximal turn). In some examples, the compressible plug 210 can extend along a majority (or even an entirety) of the functional turns in the central region 108. In one example, when the docking device 70 is deployed at a native atrioventricular valve, the compressible plug 210 does not extend into the ascending portion 110b.
  • the compressible plug 210 can move between a compressed state and a radially expanded state.
  • the guard member 104 can include a wire plug scaffold that can be radially expandable and compressible.
  • the scaffold can be radially compressed against the coil 102 so that the radial profile of the docking device 70 is smaller than a predefined threshold, for example, between 0.5 mm and 3 mm, inclusive.
  • a predefined threshold for example, between 0.5 mm and 3 mm, inclusive.
  • the compressible plug 210 moves from the compressed state to the radially expanded state, the scaffold can extend radially outwardly relative to the coil 102.
  • the compressible plug 210 can be biased toward the radially expanded state due to the shape-memory material of the wires of the mesh scaffold.
  • the compressible plug 210 can be retained in the radially compressed state by a dock sleeve of a delivery apparatus, and automatically return to the radially expanded state after the dock sleeve is removed.
  • the compressible plug 210 can include a plug scaffold and a cover substantially enclosing the scaffold.
  • the shape of the plug scaffold can generally define the shape of the compressible plug 210.
  • the cover or sealing mechanism can be inside the scaffold in order to provide the functions described herein.
  • an internal cover or sealing mechanism can be used with or without an external cover. As such, the cover or sealing mechanism does not have to be on the outside of the scaffold.
  • radial expansion of the compressible plug 210 can help preventing and/or reducing paravalvular leakage (PVL) at the medial commissure.
  • PVL paravalvular leakage
  • radial expansion of the compressible plug 210 can form an improved seal around a prosthetic valve deployed within the docking device 70.
  • the compressible plug 210 can be configured to prevent and/or inhibit leakage at the location where the docking device 70 crosses between leaflets of the native valve (e.g., at the commissures of the native leaflets).
  • the docking device 70 may push the native leaflets apart at the point of crossing the native leaflets and allow for leakage at the medial commissure (e.g., along the docking device or to its sides).
  • the compressible plug 210 can be configured to expand to cover and/or fill the medial commissure and inhibit leakage along the docking device 70 from the medial commissure. This allows the plug to cover both the medial commissure and the surrounding leaflets, such as the P2 and P3 leaflets.
  • the compressible plug 210 can help cover an atrial side of the medial commissure at an atrioventricular valve to prevent and/or inhibit blood from leaking through the native leaflets, commissures, and/or around an outside of the prosthetic valve by blocking blood in the atrium from flowing in an atrial to ventricular direction (that is, antegrade blood flow) — other than through the prosthetic valve.
  • Positioning the compressible plug 210 on the atrial side of the valve can additionally or alternatively help reduce blood in the ventricle from flowing in a ventricular to atrial direction (that is, retrograde blood flow) at the medial commissure.
  • the compressible plug 210 can be positioned on a ventricular side of an atrioventricular valve to prevent and/or inhibit blood from leaking through the native leaflets, medial commissure, and/or around an outside of the prosthetic valve by blocking blood in the ventricle from flowing in a ventricular to atrial direction (that is, retrograde blood flow). Positioning the compressible plug 210 on the ventricular side of the valve can additionally or alternatively help reduce blood in the atrium from flowing in the atrial direction to ventricular direction (that is, antegrade blood flow) — other than through the prosthetic valve.
  • FIG. 7A illustrates a scaffold 120 of a guard member 104 (described herein, FIG. 7B) that attaches to the coil 102 of the docking device 100 of FIGS. 7C and 7D.
  • the scaffold 120 includes a spine 130 with a plurality of arms 122 extending therefrom.
  • the arms 122 include a base portion 122b and a head portion 122h.
  • the scaffold 120 includes gaps 127 between the arms 122, where the gaps 127 are used as panels 140 of the guard member 104.
  • a first set of arms of the arms 122 can be linear arms as shown.
  • a last arm 125 of the arms 122 can be a lobe, also referred to as terminal lobe 125.
  • the arms 122 can have varying widths from the base portion 122b to the head portion 122h, where a narrowing taper of the width from the base portion 122b to the head portion 122h can provide for favorable characteristics when deploying the guard member. That is, the base portion 122b can be wider than the arm 122 near the head portion, where the thickness can be constant. However, the width could be constant and the thickness could narrow from the base portion 122b to the head portion 122h. This tapered arm 122 allows for the arms to better conform to the native anatomy of the valve region. The width and/or thickness of the arms can be varied to obtain different properties, as desired.
  • the guard member 104 can include the spine 130 in a shape that corresponds with the coil 102 of the docking device 70, such that both the spine 130 and coil 102 have substantially the same coil or diameter so that the bodies thereof match and can be coupled together.
  • the spine 130 from one end to the other can be cooperative with a region of the coil 102 such that they fit together and have the same curvature, such as without gaps when the spine 130 is placed on the coil 102.
  • the spine 130 could have a larger diameter, such as a diameter that match the diameter of a 29 mm valve implant. Accordingly, the arms can be in a relaxed state once the coil diameter increases with the valve.
  • the guard member e.g., brim
  • the guard member can be sewn or otherwise attached to the coil such that the spine diameter is pulled in to match the coil diameter, resulting in the brim being in tension until the valve is deployed.
  • the docking device 100 with the guard member 104 can first be advanced and delivered to the native mitral valve annulus, and then set at a desired position with the guard member covering the mitral leaflets and perimeter anatomy, prior to implantation of the prosthetic heart valve.
  • the guard member 104 is flexible and/or made of a shape memory material, so that the spine 130 coils with the docking device 100 and can be straightened for delivery via a transcatheter approach as well.
  • the scaffold 120 is made of shape memory material (e.g., nitinol) or another biocompatible material, such as stainless steel.
  • the spine 130 is configured to be shaped to match the coils/turns of the docking device 100, such as at the central region 80, the effective diameter of the spine 130 can be kept relatively small in diameter (e.g., to match the central region 80 in one embodiment can have an inner diameter of between approximately 21-24 mm ⁇ 2 mm or another diameter smaller than the prosthetic valve and/or the native annulus) in order to increase retention force with the prosthetic valve.
  • guard member 104 can be placed at a location on the central region 80 where the guard member 104 inhibits further advancing of the docking device 100 around the existing leaflets and/or chordae tendineae, and guard member 104 is shaped to help deliver the docking device 100 to a desired position relative to the native mitral annulus.
  • the spine 130 could be of the larger embodiments as described above.
  • the spine 130 can include a leading end 132 and a trailing end 134 with a concave side 136 therebetween.
  • the concave side 136 can be shaped to match the coil 102 of the docking device 100.
  • the arms 122 extend from a convex side 138 of the spine 130, and thereby away from the coil 102 of the docking device 100.
  • the spine 130 can be shaped to match the coil 102, the spine 130 may or may not be directly coupled with the coil 102.
  • the coil 102 can include a material that can be coupled with the material of the spine 130, such as by sewing, stitching, suturing, brazing, welding, adhesive, or the like.
  • the docking device 100 may include a material cover around the base coil 102, and the spine 130 may also include a material cover (e.g., flap 118) that can be coupled with the cover of the coil 102. That is, the covers of the two components can be coupled together, such as by suturing, sowing, adhesive, clipping, or otherwise affixing the guard member 104 to the docking device 100, which is discussed in more detail herein.
  • the guard member 104 can be stitched to the coil 102 with sutures to couple the guard member 104 to the coil 102.
  • the length of the spine 130 can be modulated depending on the design of the docking device 100. Accordingly, the spine 130 can be configured to cover a certain percentage of a full coil turn or even a full 360 degree turn or more.
  • the spine length can be tailored so that is matches with the mitral valve anatomy and provides a sufficient length for arms 122 extending therefrom to engage and overlap the anatomy to provide a cover.
  • the length of the spine 130 can be relative to the central region 80 of the docking device 100.
  • the length of the spine 130 from the leading end 132 to the trailing end 134 can be from about 20 mm to about 110 mm, from about 30 mm to about 100 mm, from about 40 mm to about 90 mm, from about 45 mm to about 80 mm, or about 50 mm to about 75 mm. In some embodiments, the length can be about 54 mm.
  • the thickness of the scaffold 120 can also be varied as needed or desired. In some embodiments, the thickness may be referring to the Z dimension relative to the X-Y area of the page. The thickness is the height of the scaffold 120 while the scaffold 120 is laid on its side with the arms 122 extending across the horizontal plane. The thickness can range from about 0.1 mm to about 0.8 mm, from about 0.2 mm to about 0.6 mm, from about 0.3 mm to about 0.5 mm, from about 0.4 to about 0.45 mm. In some aspects, the spine 130 and the arms 122 can have the same thickness. In other aspects, the spine 130 may have a larger thickness compared with the arms 122.
  • the width of the spine 130 and arms 122 can also vary.
  • the width which is orthogonal with the thickness, defines dimension in the X-Y plane of the component.
  • the width of the spine 130 is between the concave side 136 and the convex side 138.
  • the corresponding dimension of the arms 122 is also considered the width.
  • the width of the spine 130 and/or the arms 122 can independently range from about 0.05 mm to about 0.5 mm, from about 0.1 mm to about 0.4 mm, from about 0.13 mm to about 0.3 mm, from about 0.16 to about 0.25 mm, or from about 0.15 mm to about 0.20 mm.
  • the arm can taper from about 0.35 mm to about 0.05 mm, or from about 0.25 mm to about 0.1 mm.
  • the arms 122 can be distributed along the convex side 138 of the spine 130 as shown in FIG. 7A.
  • the arms 122 are shown to have the base portion 122b attached to the spine 130 with the head portion 122h on the opposite end of the arms 122.
  • the arm 122 can include a straight portion 122c extending from the base portion 122b for a certain length, which then turn into an arc 122a that bends the arm 122 in a bend region 122d around so that the arm 122 has the bend region 122d that is somewhat parallel with the spine 130. That is, the arc 122a turns the direction of the arm 122 so that the bend region 122d is oriented in about the same direction as the spine 130. Also, it is noted that the bend region 122d and head portion 122h are oriented away from the leading end 132 and pointed toward the trailing end 134; however, the head of the arms could be pointed toward the leading end and oriented away from the trailing end.
  • the arms 122 can range from about 4 arms to about 10 arms, from about 3 arms to about 20 arms, or about 4 arms to about 15 arms, or about 5 arms to about 10 arms, or about 6 arms to about 8 arms.
  • the arms 122 can vary in length from the base of the base region 122b (e.g., from spine 130) to the tip of the head region 122h from about 10 mm to about 60 mm, from about 20 mm to about 50 mm, from about 25 mm to about 45 mm, from about 30 mm to about 43 mm, or about 35 mm to about 40 mm.
  • the straight portion 122c can have a length of about 6 mm to about 50 mm, from about 8 mm to about 40 mm, from about 10 mm to about 30 mm, or from about 15 mm to about 20 mm.
  • the arc 122a can have an angle from about 20 degrees to about 90 degrees, from about 30 degrees to about 80 degrees, from about 40 degrees to about 70 degrees, or from about 50 degrees to about 60 degrees.
  • the bend region 122d and the head region 122h may be the dimension of the arm 122 minus the dimension straight region 122c. However, the lengths of the arm can vary across different embodiments or across the different arms of the same scaffold. In some aspects, the size of the scaffold component is larger in diameter than the coil 102 of the docking station.
  • the guard member When the guard member is attached to the docking station, the guard member has more radial coverage with the flap of the guard member. Also, the flap member of the guard member is cut larger than the docking station (e.g., 33 mm diameter of flap as compared to the dock diameter of 29 mm after implant) so the textile materials of the flap are stretched tight during attachment, mitigating wrinkles in the textiles.
  • the docking station e.g., 33 mm diameter of flap as compared to the dock diameter of 29 mm after implant
  • the arms 122 can be separated from each other by a dimension of about 0.3 mm to about 15 mm, from about 0.75 mm to about 10 mm, from about 1 mm to about 8 mm, from about 1.25 mm to about 6 mm.
  • the head portion 122h may also be referred to as the head 122h herein.
  • the head 122h can have a rounded shape with or without an aperture.
  • the head 122h can include a loop 1221 shape that defines an aperture 122k, which dimensions can vary.
  • the loop 1221 and aperture 122k is shown to have a teardrop shape; however, the shape can be completely circular, oval, or other variation of roundedness.
  • the head 122h can be configured so that it does not have any sharp ends or points, which can minimize puncturing of the flap 118 or the mitral valve tissue or related anatomy.
  • the head 122h provides for a rounded feature that is blunted to inhibit any puncturing.
  • the scaffold 120 may also have a terminal lobe 125, which may also be referred to as a petal herein or in the incorporated references. However, two terminal lobes 125 can be placed on the scaffold, with one at each end.
  • the terminal lobe 125 is shown to have two ends 125a, b attached to the spine 130 to form the loop 1251 and aperture 125k. However, only a single end may be attached to the spine 130, such as at or near the trailing end 134.
  • the terminal lobe 125 can have various dimension and may be oblong or somewhat teardrop shaped.
  • the terminal lobe 125 can have a length of about 5 mm to about 50 mm, from about 10 mm to about 40 mm, or from about 20 to about 30, or about 21 mm.
  • the terminal lobe 125 can have a width from about 3 mm to about 30 mm, from about 5 to about 25 mm, from about 10 mm to about 20 mm, or from about 11 mm to about 15 mm, or about 10.5 mm.
  • the scaffold 120 can include a shape memory material that is shape set and/or pre-configured to expand the guard member 104 to the radially expanded state when unconstrained (for example, when deployed at a native valve location).
  • the scaffold 120 can contain a shape memory alloy with super-elastic properties, such as Nitinol.
  • the scaffold 120 can contain a ternary shape memory alloy with super-elastic properties, such as NiTiX where X can be chromium (Cr), cobalt (Co), zirconium (Zr), hafnium (Hf), etc.
  • the scaffold 120 can comprise a metallic material that does not have the shape memory properties.
  • the scaffold 120 can have a biasing mechanism (e.g., using springs, etc.) configured to bias the scaffold 120 (and the guard member 104) to the radially expanded state.
  • metallic material include cobalt-chromium, stainless steel, etc.
  • the scaffold 120 can comprise nickel-free austenitic stainless steel in which nickel can be completely replaced by nitrogen.
  • the scaffold 120 can comprise cobalt-chromium or cobalt-nickel-chromium-molybdenum alloy with significantly low density of titanium.
  • FIG. 7B illustrates a flap 118 of the guard member 104, as described herein.
  • the flap 118 is adapted to fit over the scaffold 120 to form the guard member 104.
  • the flap 118 can include a at least one flap sheet 150 that has sleeves 121 formed of sleeve sheet 152 coupled with the flap sheet 150, such as with sheet stiches 154, adhesive, or other attachment means. Multiple sheets can be used, and the sleeves can be stitched out of the multiple sheets, whether over or under the scaffold 120.
  • the flap 118 is shown to include five panels 140 and one terminal panel 140a configured as a terminal petal, with a petal shape (e.g., teardrop-like shape).
  • the flap sheet 150 can be one or more sheets, and may be configured as at least two sheets coupled (e.g., stitched) together to form a cover that with a cavity slips over the arms to cover both sides so that the arms are in the cavity between the sheets. Any embodiment of the one or more flap sheets 150 is considered herein.
  • the sleeves 121 can be tubes, such as braded tubes, which can fit over the arms like a sock with a closed end. This closed end can be formed through the braiding process, or sealed closed via heat sealing (e.g., using a laser or soldering iron to melt the opening closed), sutures, or other methods of closing a braided tube. Other sleeve configurations can also be used.
  • the flap 118 of FIG. 7B is fit onto the scaffold 120 of FIG. 7A to form the guard member 104.
  • the guard member is then coupled to the coil 102 of FIG. 6A to form the docking device 100 having the guard member 104 of FIGS. 7C-7D.
  • the flap 118 can be a single flap sheet 150 or a plurality of flap sheets 150 affixed to the scaffold 120 by any means.
  • the affixing can be via the flap 118 being sutured to the scaffold 120, such as by loop stitches 156.
  • another sheet whether flat or tubular (e.g., sock), can be configured as a sleeve 121 that receives the arms 122 and is coupled with the flap sheet 150 via sheet stiches. Accordingly, different coupling systems can be used to couple the flap sheet 150 to the scaffold 130.
  • At least one arm 122 is coupled to the flap 118 by having the flap sheet 150 coupled with a sleeve sheet 152 with the arm 122 therein with sheet stiches 154 coupling the flap sheet 150 to the sleeve sheet 152.
  • the flap 118 is a flat sheet of material, such as a fabric, film, membrane, plastic sheet, foil, or the like.
  • the sleeve sheet 152 is a flat sheet of material, which can be the same or different material from the flap 118.
  • the arm 122 is fit between the flat flap sheet 150 and flat sleeve sheet 152 with sheet stitches 154 stitching each side of the arm 122 to form the sleeve 121.
  • the arm 122 is able to freely move inside of the sleeve component that protects the arms, which enhances the ability to compress the guard member into the catheter tube.
  • At least one arm 122 is coupled to the flap 118 by having the sleeve sheet 152 formed as a tube (e.g., two open ends) or sock (e.g., one open end) slipped over the arm 122 and stitched (e.g., 154) to the flap sheet 150.
  • the sleeve sheet 152 encapsulates the arm 122 to provide additional protection, which can be beneficial to the mitral valve tissue.
  • the tubular or sock sleeve sheet 152 can also be made from the same materials as the flat flap sheet 150, but may or may not be the same material in a particular embodiment.
  • At least one arm 122 is coupled to the flap 118 by having loop stiches 156 stitching a single arm 122 to a flap sheet 150.
  • the loop stiches 156 can go through the flap sheet 150 and around the respective arm 122 and back through the flap sheet 150 on the other side of the arm 122 to form a looping stitch around the arm 122.
  • Various types of loop stiches 156 can be used so long as the stitching forms a loop coupling the arm 122 to the flap sheet 150.
  • the terminal lobe 125 is basically an arm with both ends coupled to the spine 130. As such, the terminal lobe 125 may not be adapted to receive the tube or sock sleeve configuration.
  • such a terminal lobe 125 does not have any sharp points, ends or edges. Accordingly, the arm of the terminal lobe 125 can be loop stitched to the flap sheet 150.
  • the guard member can include stitching around the base of the terminal lobe (e.g., loop), whereas at the end of the terminal lobe it is only stitched on the inner diameter. Therefore, the lobe can move within the flap member to allow the terminal lobe to collapse into the catheter.
  • At least one arm 122 is coupled to the flap 118 by having loop stiches 156 stitching a single arm 122 between a flap sheet 150 and flat sleeve sheet 152, where loop stiches 156 are used.
  • the loop stiches 156 can go through the flap sheet 150 and the flat sleeve sheet 152 around the respective arm 122 and back through the flat sleeve sheet 152 and flap sheet 150 on the other side of the arm 122 to form a looping stitch around the arm 122 and the flap sheet 150 and flat sleeve sheet 152.
  • Various types of loop stiches 156 can be used so long as the stitching forms a loop coupling the arm 122 to the flap sheet 150.
  • various methods can be used for the attachment, such as whip stiches, running a stitch that follows the perimeter of the arm, heat coupling, or other attachment methods.
  • the flat sleeve sheet 152 can be configured as a flat lobe sheet 158.
  • the flat lobe sheet 158 can be loop stitched with the terminal lobe 125 between the flap sheet 150 and flat lobe sheet 158.
  • the flap sheet 150 is loop stitched via the loop stiches 156 to the flat lobe sheet 158 with the terminal lobe 125 therebetween.
  • the flat lobe sheet 158 can be configured as a terminal petal, with a petal shape (e.g., teardrop-like shape), as shown in FIG 7B.
  • other methods of attachment such as described herein or generally known, can be used for forming the attachment.
  • the guard member 104 is shown to include five panels 140 and one terminal panel 140a formed from the scaffold 120 and the flap 118.
  • the panels 140 can be regions of the flap sheet 150 between the arms 122.
  • the panels 140 can function as flat umbrella panels that can fold up when the scaffold 120 is folded into a delivery orientation and then expand once the scaffold 120 is released into a deployed orientation.
  • the panels 140 can be various shapes and sizes for different configurations.
  • the panels 140 extend from the spine 130 out past the arms 122 to provide a brim feature with respect to the delivery device 70.
  • the panels 140 can provide a barrier that is flexible and can contour with the mitral valve anatomy.
  • the panels 140 can inhibit fluid flow from passing the guard member 104, and thereby can function to guard against paravalvular leakage.
  • the panels 140 may also allow for cellular ingrowth depending on the type of material, which can facilitate implantation and longevity of beneficial function.
  • the arms 122, sleeves 121, terminal lobe 125 and lobe sleeve 158 can be oriented clockwise or counter-clockwise in the deployed orientation. That is, these component can be oriented with respect to the coil 102 of the docking device 70 as illustrated in clockwise deployment or in the opposite direction in counter-clockwise deployment. While all of the arms 122 and terminal lobe 125 are oriented in the same direction as illustrated, the terminal lobe 125 may be oriented in the opposite direction (e.g., counterclockwise) while the arms 122 are still in clockwise orientation. Additionally, one or more arms 122 may be substituted with lobes, which can be internal lobes. Also, the terminal lobe 125 can be substituted with a terminal arm.
  • the flap 118 may also be coupled with the spine 130 of the scaffold 120.
  • the flap 118 may be affixed with the spine 130 in a similar manner as the flap sheet 150 is fixed to an arm 122.
  • the flap 118 can be loop stitched with the spine 130 so that the flap 118 covers the spine 130.
  • the stitching can also secure the guard member 104 to the coil member.
  • the flap sheet 150 can be looped around the spine itself and then stitched or loop stitched, which forms an interrupted tubular covering of the flap sheet 150 around the portions of the spine 130 between the arms 122, which interrupted tubular cover can be referred to as a spine sleeve 153.
  • another sheet material can be used for forming the spine sleeve 153, which can be performed similar to the arm as described herein.
  • the flap 118 can be configured to be so elastic that when the guard member 104 moves from the delivery orientation to the deployed orientation, the flap 118 can accommodate the scaffold 120.
  • the flap 118 can be configured to be atraumatic to native tissue and/or promote tissue ingrowth into the flap 118.
  • the flap 118 can have pores to encourage tissue ingrowth.
  • the flap 118 can be impregnated with growth factors to stimulate or promote tissue ingrowth, such as transforming growth factor alpha (TGF-alpha), transforming growth factor beta (TGF-beta), basic fibroblast growth factor (bFGF), vascular epithelial growth factor (VEGF), and combinations thereof.
  • TGF-alpha transforming growth factor alpha
  • TGF-beta transforming growth factor beta
  • bFGF basic fibroblast growth factor
  • VEGF vascular epithelial growth factor
  • the flap 118 can be constructed of any suitable material, including foam, cloth, fabric, and/or polymer, which is flexible to allow for compression and expansion of the flap 118.
  • the flap 118 can include a fabric layer constructed from a thermoplastic polymer material, such as polyethylene terephthalate (PET).
  • PET polyethylene
  • the flap 118 can be configured to engage with the prosthetic valve deployed within the docking device so as to form a seal and reduce paravalvular leakage between the prosthetic valve and the docking device after the guard member 104 is radially expanded.
  • the flap 118 can also be configured to engage with the native tissue (for example, the native annulus and/or native leaflets) to reduce PVL between the docking device and/or the prosthetic valve and the native tissue.
  • the flap 118 can include an edge protector 151 at a peripheral lip that is the region peripheral to the arms 122 and/or sleeves 121.
  • the edge protector 151 can be a part of the flap sheet 150 or a separate member coupled with the flap sheet 150.
  • FIGS. 7C-7D show a docking device 100 with a coil 102 coupled to a guard member 104, according to one or more embodiments of the present disclosure.
  • the docking device 100 can, for example, be implanted within a native valve annulus.
  • the docking device 100 can be configured to receive and secure a prosthetic valve (e.g., prosthetic heart valve 62), thereby securing the prosthetic valve at the native valve annulus.
  • a prosthetic valve e.g., prosthetic heart valve 62
  • the docking device 100 can comprise a coil 102 and a guard member 104 (i.e. , “a PVL guard” or “a sealing member” or a “brim feature”) extending along at least a portion of the coil 102.
  • the coil 102 can include a shape memory material (e.g., nickel titanium alloy or Nitinol) such that the docking device 100 (and the coil 102) can move from a substantially straight or elongated configuration (i.e., “delivery orientation”) when disposed within a delivery sheath of a delivery apparatus (e.g., docking device delivery apparatus 50) to a helical configuration (i.e., “deployed orientation,” as shown in FIG.
  • a shape memory material e.g., nickel titanium alloy or Nitinol
  • the arms 122 of the guard member 104 are folded up against the spine 130 so that the panels are folded inward.
  • the arms 122 are released and extend out away from the spine 130, which provides a brim feature for covering the mitral valve anatomy.
  • the guard member 104 can be retained in a radially compressed state by a dock sleeve of the delivery apparatus. After the docking device 100 is deployed at the implantation site, the dock sleeve can be removed so as to expose the guard member 104, thereby allowing the guard member 104 to move to a radially expanded state, such as in FIGS 7C-7D. In some examples, when the docking device 100 is in the deployed orientation and the guard member 104 is in the radially expanded state, the guard member 104 can extend circumferentially, radially, or laterally relative to a central longitudinal axis 101 of the docking device 100.
  • the guard member 104 can extend around the circumference of a turn in the coil 102 from 90 degrees to 400 degrees, or from 140 degrees to 330 degrees, or from 180 degrees to 290 degrees, or from 220 degrees to 280 degrees (e.g., 270 degrees) relative to the central longitudinal axis 101.
  • the guard member 104 can extend circumferentially from about one half of a revolution (e.g., 180 degrees) around the central longitudinal axis 101 in some examples to more than a full revolution (e.g., 400 degrees) around the central longitudinal axis 101 in other examples, including various ranges in between.
  • a range (e.g., from 180 degrees to 400 degrees, and between 180 degrees and 400 degrees) includes the endpoints of the range (e.g., 180 degrees and 400 degrees), as will all ranges recited herein being inclusive of the endpoints.
  • the guard member 104 can achieve at least 360 degrees of coverage of the valve anatomy in the atrium. The unfolding of the guard member 104 allows for such coverage. Examples can include about 45 degrees of coverage to about 400 degrees of coverage, about 90 degrees of coverage to about 360 degrees of coverage, about 120 degrees of coverage to about 300 degrees of coverage, or about 180 degrees of coverage to about 225 degrees of coverage.
  • the coil 102 has a proximal end 102p and a distal end, with the guard member 104 therebetween, which also respectively define the proximal and distal ends of the docking device 100.
  • the docking device 100 can be releasably coupled to a delivery apparatus (e.g., docking device delivery apparatus 50).
  • the docking device 100 can be coupled to the delivery apparatus via a release suture that can be configured to be tied to the docking device 100 and cut for removal.
  • the release suture can be tied to the docking device 100 through an eyelet or eyehole 103 located adjacent the proximal end 102p of the coil.
  • the release suture can be tied around a circumferential recess that is located adjacent the proximal end 102p of the coil 102.
  • the docking device 100 in the deployed orientation can be configured to fit at the mitral valve position with the guard member 104 covering the mitral anatomy laterally from the coil 102 in the left atrium.
  • the guard member 104 can provide a lateral barrier on a peripheral of the mitral valve anatomy in the left atrium intersection with the mitral valve anatomy.
  • the docking device 100 can also be shaped and/or adapted for implantation at other native valve positions as well, such as at the tricuspid valve.
  • the geometry of the docking device 100 and the guard member 104 thereof can be configured to engage the native anatomy, which can, for example, provide for increased stability and reduction of relative motion between the docking device 100, the prosthetic valve docked therein, and/or the native anatomy.
  • Reduction of such relative motion can, among other things, prevent material degradation of components of the docking device 100 and/or the prosthetic valve docked therein and/or prevent damage or trauma to the native tissue. Also, the guard member 104 can inhibit paravalvular leaking of blood the wrong direction in the valvular pathway.
  • the guard member 104 can extend along a portion (for example, the atrial portion) of the stabilization turn 110 of the coil 102. In some examples, the guard member 104 can extend along at least a portion of the central region 108 of the coil 102 (for example, a portion of the most proximal turn). In some examples, the guard member 104 can extend along a majority (or even an entirety) of the functional turns in the central region 108. In one example, when the docking device 100 is deployed at a native atrioventricular valve, the guard member 104 does not extend into the ascending portion 110b.
  • the guard member 104 can move between a radially compressed state and a radially expanded state.
  • the guard member 104 can include a plurality of arms 122 which can be radially expandable and compressible.
  • the guard member 104 has four panels 140, including one panel configured as a distal lobe 140d and three proximal panels 140p.
  • the guard member 104 can have two, three, four, five, six, seven, eight, nine, or more than ten panels 140.
  • the panels 140 can extend circumferentially along a portion of the coil 102 of the docking device 100.
  • the terminal panel can be in the form of a distal petal 140d, which may or may not include an arm, a wire frame, or a loop.
  • the distal petal 140d may have an arm 122 in a sleeve, or it can include a wire frame 123 as shown between two flap sheets, which wire frame 123 can be the same material as the scaffold 120.
  • the panels 140 can be radially compressed against the coil 102 so that the radial profile of the docking device 100 is smaller than a predefined threshold, for example, between 2 mm and 3 mm, inclusive.
  • a predefined threshold for example, between 2 mm and 3 mm, inclusive.
  • the guard member 104 moves from the radially compressed state to the radially expanded state, the panels 140 can extend radially outwardly relative to the coil 102.
  • the guard member 104 can be biased toward the radially expanded state.
  • the guard member 104 can be retained in the radially compressed state by a dock sleeve of a delivery apparatus, and automatically return to the radially expanded state after the dock sleeve is removed.
  • the guard member 104 can include a scaffold 120 and a flap 118 substantially enclosing the scaffold 120.
  • the shape of the scaffold 120 can generally define the shape of the guard member 104.
  • the scaffold 120 can include a spine 130 and a plurality of arms 122 connected to the spine 130.
  • the spine 130 defines an inner edge of the guard member 104 and can be attached to the coil 102.
  • Each arm 122 can extend radially outwardly from the spine 130 within a corresponding panel 140.
  • radial expansion of the guard member 104 can help preventing and/or reducing paravalvular leakage (PVL). Specifically, radial expansion of the guard member 104 can form an improved seal around a prosthetic valve deployed within the docking device 100.
  • the guard member 104 can be configured to prevent and/or inhibit leakage at the location where the docking device 100 crosses between leaflets of the native valve (for example, at the commissures of the native leaflets). For example, without the guard member 104, the docking device 100 may push the native leaflets apart at the point of crossing the native leaflets and allow for leakage at that point (for example, along the docking device or to its sides). However, the guard member 104 can be configured to expand to cover and/or fill any opening at that point and inhibit leakage along the docking device 100.
  • the inner cover 112 and/or the retention member 114 can have slack.
  • FIG. 7C shows that the inner cover 112 can be axially compressed to have slack 115 before radially expanding a prosthetic valve within the docking device 100.
  • the inner cover 112 can be constructed with a low density ePTFE so that the inner cover 112 can be axially compressed and the resulting slack 115 does not significantly impact the radial profile of the docking device 100.
  • the docking device 100 may be further radially expanded, which can cause the coil 102 to rotate within the native annulus (also referred to as “clocking”).
  • the slack 115 allows the inner cover 112 to be axially stretched and not rotate together with the coil 102 (that is, the coil 102 may slide axially relative to the inner cover 112). Because the guard member 104 can be fixedly attached to the retention member 114, the slack 115 can also prevent the guard member 104 from rotating and pinning open the native leaflets during the clocking.
  • the guard member 104 can help cover an atrial side of an atrioventricular valve to prevent and/or inhibit blood from leaking through the native leaflets, commissures, and/or around an outside of the prosthetic valve by blocking blood in the atrium from flowing in an atrial to ventricular direction (that is, antegrade blood flow) — other than through the prosthetic valve. Positioning the guard member 104 on the atrial side of the valve can additionally or alternatively help reduce blood in the ventricle from flowing in a ventricular to atrial direction (that is, retrograde blood flow).
  • the guard member 104 can be positioned on a ventricular side of an atrioventricular valve to prevent and/or inhibit blood from leaking through the native leaflets, commissures, and/or around an outside of the prosthetic valve by blocking blood in the ventricle from flowing in a ventricular to atrial direction (that is, retrograde blood flow). Positioning the guard member 104 on the ventricular side of the valve can additionally or alternatively help reduce blood in the atrium from flowing in the atrial direction to ventricular direction (that is, antegrade blood flow) — other than through the prosthetic valve.
  • FIG. 7E shows an embodiment of a docking device that includes a coil 102 having a guard member 104 and a compressible plug 210.
  • the compressible plug 210 is shown to be distal compared to the guard member 104 on the coil 102. This results in a protruding coil region 102J (FIG. 8A) that is proximal of the compression plug 210 or at the guard member 104, an enclosed coil region that is within or adjacent to the compressible plug 210, and a protruding coil region 1021 that extends distally from the compressible plug 210.
  • Either the coil 201 is within an internal lumen of the compressible plug 210 or the coil 210 is attached to an end or side of the compressible plug 210.
  • the base end 214 is attached to the coil 102 with the plug coupling 230 such that the coil 102 extends from the second opening 222b at the flared end 212 of the compressible plug. Also, the first opening 222a receives the proximal end of the coil 102 therethrough into the internal lumen of the scaffold. However, any attachment means can be used.
  • the optional guard member 104 is also shown.
  • the compressible plug 210 forms a plug with the guard member 104, so that both the compressible plug 210 and guard member 104 cooperate to block fluid leakage.
  • the compressible plug 210 can form a plug along with the terminal lobe of the guard member 104 to inhibit PVL.
  • the compressible plug 210 and guard member 104 may be so close that there is no gap, such as both being in contact or overlapping.
  • the plug and guard member can omit any gaps that can leak fluid between the coil, the terminal pedal of the guard member, and the plug.
  • the proximal end of the compressible plug may also be attached next to the dock core (e.g., coil), such that the dock core does not go through the plug. That is, the coil is retained outside of the plug.
  • the distal end of the plug e.g., 244
  • This sealing of the distal end can be done with a crimp or suture wrap at the distal end of the braid of the plug.
  • a method to protect the braid ends can be used to enhance the structural integrity of the plug, such as by welding the braid ends or applying a protective layer, such as an adhesive, to the braid ends.
  • FIG. 7F shows a side view of the docking device of FIG. 7E. As shown, the distal end with the protruding coil region 1021 of the coil 102 extends from the second opening 222b of the compressible plug 210. The optional guard member 104 is also shown. Exemplary Medial Commissure Plug
  • FIG. 8A illustrates an embodiment of a compressible plug 240 having a plug cover 242 over the compressible plug scaffold of one of the examples provided herein.
  • the compressible plug 240 includes bulbous shape with a plug body 246 that is tapered from a plug face 244 (e.g., distal end).
  • the plug face 244 can be solid, or it can be a conduit or plug end, whether flat or rounded.
  • the conduit configuration of the plug face 244 allows the coil to extend therethrough.
  • the compressible plug 240 is attached to the coil 102 at a side, such that the distal coil protrusion 102J passes from the distal side of the compressible plug 240.
  • the coil 102 can be attached to the compressible plug 240 at any location or by any attachment means.
  • This embodiment includes a three- dimensional expanded shape of the compressible scaffold with a conical body region 247 with a tapered first end region and rounded second end region.
  • the conical body region 247 can be symmetrical or asymmetrical as shown.
  • the body also include an annular section between the conical body region 247 and the plug face 244.
  • the compressible plug 240 can include a hollow external shell, a first end that is tapered, and an annular region that is partially toroidal or a second end that with a flattened face with or without a conduit.
  • FIG. 8B illustrates an embodiment of a compressible plug 250 having a plug cover 242 over the compressible plug scaffold of one of the examples provided herein.
  • the compressible plug 250 includes bulbous shape with a plug body 246 that is tapered from a plug face 244.
  • the plug face 244 can be solid, or it can be a conduit or plug end, whether flat or rounded.
  • the conduit configuration of the plug face 244 allows the coil 102 to extend therethrough.
  • the compressible plug 250 is attached to the coil 102 at a side, such that the distal coil protrusion 102J passes from the distal side of the compressible plug 250.
  • the coil 102 can be attached to the compressible plug 250 at any location or by any attachment means.
  • This embodiment includes a three- dimensional expanded shape of the compressible scaffold with a conical body region with a tapered first end region and rounded second end region.
  • the conical body region can be symmetrical or asymmetrical as shown.
  • the body also include an annular section between the conical body region and the plug face 244.
  • the body includes a hood region 248, which can be configured as a tubular region.
  • the compressible plug 250 can include a hollow external shell, a first end that is tapered, and an annular region that is partially toroidal or a second end that with a flattened face with or without a conduit.
  • the compressible plug 250 is also shown to have a second end with a sharply tapered face and a second end that has an angled leading edge to the sharply tapered face.
  • FIG. 8B shows the three-dimensional expanded shape of the compressible scaffold includes a conical body region with a tapered first end region and a tubular region to a second end.
  • FIG. 8B also shows the three-dimensional expanded shape of the compressible scaffold includes a conical body portion with a tapered first end and an angled leading edge rounded to an angled face, wherein the angled face is flat or curved.
  • FIG. 8C illustrates an embodiment of a disc shaped compressible plug 260 having a plug cover 242 over the compressible plug scaffold of one of the examples provided herein.
  • the compressible plug 260 includes bulbous shape with a flat plug body 262 that is in the shape of a plate or disc.
  • the flat plug body 262 has a plate top 264 and a plate side 266, and a plate bottom (not shown).
  • the flat plug body 262 can be solid, or it can include a conduit to receive the coil 102 as shown. The conduit configuration on the side or in the middle allows the coil to extend therethrough.
  • the compressible plug 260 is attached to the coil 102 at a side, such that the distal coil protrusion 102J passes from the distal side of the compressible plug 250.
  • the coil 102 can be attached to the compressible plug 250 at any location or by any attachment means.
  • This embodiment is a disc shaped compressible plug 260, which has two wings ( e.g., half of disc) extending from the coil 102.
  • the compressible plug 260 can include a hollow internal core, with or without the hollow internal core with the lumen.
  • This embodiment shows the three-dimensional expanded shape of the compressible scaffold includes a disc portion having two disc faces and an annular region therebetween.
  • FIG 8C can also illustrate a three-dimensional expanded shape of the compressible scaffold including at least one lateral wing having a wing top surface and wing bottom surface. While both lateral wings are shown, only one lateral wing may be used, which would be half of the illustrated shape.
  • FIG. 8D illustrates a compressible plug 290 having a scaffold 292 filled with pluggable members 294, which can be absorbent or hydrophobic.
  • the pluggable members 294 are compressible.
  • the pluggable members 294 can be any shape and can vary in size. Spherical pluggable members can be used, which could also be rods, cylinders, discs, cubes, rectangles, flat members, fluffed members, random shapes, or irregular shapes. For example, a flat or fluffy cloth material can be used as a pluggable member.
  • FIG. 9A illustrates an embodiment of a compressible plug 340 having a plug cover 342 over the compressible plug scaffold of one of the examples provided herein.
  • the compressible plug 340 includes bulbous shape with a plug body 346 that is tapered from a plug face 344.
  • the plug face 334 can be solid, or it can be a conduit or plug end, whether flat or rounded.
  • the conduit configuration of the plug face 344 allows the coil to extend therethrough.
  • the compressible plug 340 is attached to the coil 102 at a side, such that the distal coil protrusion 102J passes from the distal side of the compressible plug 340.
  • the coil 102 can be attached to the compressible plug 340 at any location or by any attachment means.
  • This embodiment includes a three- dimensional expanded shape of the compressible scaffold with a conical body region with a tapered first end region and rounded second end region.
  • the conical body region can be symmetrical or asymmetrical as shown.
  • the body also include an annular section between the conical body region and the plug face 344.
  • the body includes a hood region 348, which can be configured as a tubular region.
  • the compressible plug 340 can include a hollow external shell, a first end that is tapered, and an annular region that is partially toroidal or a second end that with a flattened face with or without a conduit.
  • the compressible plug 340 is also shown to have a second end with a sharply tapered face and a second end that has an angled leading edge to the sharply tapered face. Additionally, the compressible plug includes a plug back 346 and a hood 348. A gap 352 between the plug face 344 and a plug plate 354.
  • the plug plate 354 can include a plate face 356 with a plug sidewall 358, with a plate face 356 pacing the plug face 344.
  • a connector 359 (e.g., throat or waist region) is located between the plug face 344 and the plug plate 354. This provides for two body regions to the compressible plug, which include the plug back 346 and the plug plate 354.
  • FIG. 9B shows a bottom view of the compressible plug 340, which shows the connector 359 as a throat between the two body regions.
  • FIGS. 9A-9B show the three- dimensional expanded shape of the compressible scaffold including: a conical body portion with a tapered first end and an angled leading edge rounded to an angled face, and a disc portion having two disc faces and an annular region therebetween.
  • FIG. 10A illustrates a side view of another embodiment of a compressible plug 370.
  • the compressible plug 370 has a plug cover 372, which covers the plug back 376 and the plug plate 384.
  • a connector 378 e.g., neck
  • the plug plate 384 includes a plug face 386, which can have the conduit as described herein.
  • the compressible plug 370 shows the coil 102 having a distal region 102J (e.g., protruding coil region) extending from the plate face 386, which can be symmetrical or asymmetrical.
  • a plug sidewall 388 forms an annular region of the plug plate 384 between the connector 379 and plug plate face 386 facing the plug back 376.
  • FIG. 10B shows a perspective view of the compressible plug 370, with the plug back 376, plug plate with the plug face 386.
  • FIG. 10C shows another perspective view of the compressible plug 370 to show the tapered body separated from the disc body.
  • Both the main body and plate can have a hollow external shell, where the main body has a first end that is tapered and a second end that is partially toroidal or with a second end that with a flattened face.
  • An intermediate narrowed throat is provided between the main body and disc body with an intermediate narrowing section to a narrowed throat and an intermediate expanding section from the narrowed throat in opposite directions.
  • This embodiment also includes a three-dimensional first body portion and a three-dimensional second body portion.
  • the main three-dimensional first body portion includes a first tapered end and an intermediate narrowing section, then there is an intermediate narrowed throat before the disc shaped three-dimensional second body portion with an intermediate expanding section, an expanded end that is annular, and with a narrowed end face.
  • FIGS. 10A-10C show the three-dimensional expanded shape of the compressible scaffold includes: a conical body portion with a tapered first end and an angled leading edge rounded to an angled face, and a disc portion having two disc faces and an annular region therebetween.
  • All embodiments may include a hollow internal core with an internal space between a hollow external shell and hollow internal core. All embodiments can include a hollow internal core formed as a conduit with an internal lumen. All embodiments can include a second end that is tapered.
  • FIGS. 11 A and 1 IB show a plug scaffold 400 that can have an expanded orientation 401a and a compressed orientation 401b.
  • the plug scaffold 400 is shown to have a plug back 402 and a plug plate 406 separated by a plug gap 408 at a plug throat 404.
  • longitudinally elongating the plug scaffold 400 elongates the shape, which can be conducted until fully elongated and substantially tubular.
  • longitudinally compressing the plug scaffold 400 compresses the shape, which can be conducted until fully compressed. Removing forces from the plug scaffold 400 results in the shape returning to the shape-memory defined shape.
  • the woven or braided pattern when the plug scaffold 400 is compressed, can be configured so that the body radially expands as shown in Fig. 1 IB.
  • This radial expansion can facilitate covering the medial commissure and the adjacent leaflets to inhibit leakage,
  • the atrial portion of the dock rotates towards the ventricle, and the plug reaches its compressed (and radially larger) shape. It can remain in this shape as the final implant configuration.
  • FIG. 11C shows the compressible plug 420 having a cover 410 over the plug scaffold 400.
  • the compressible plug 420 is coupled to the coil 102 via a plug coupling 430.
  • the plug coupling can be a wrap, suture, adhesive, or other coupling to secure the compressible plug to the coil 102.
  • the compressible plug 420 hangs from the coil 102 with one attachment point at the tapered end of the body.
  • FIG. 1 ID shows the plug scaffold 400 without the cover being attached to the coil 102 with the plug coupling.
  • the plug scaffold 400 hangs from the coil 102 instead of having the coil going through a lumen.
  • the plug scaffold is closed off at both ends without an internal lumen.
  • a space is provided in both the main plug scaffold body and the disc body.
  • the optional guard member 104 is also shown.
  • different techniques can be used to prepare the docking device having the guard member.
  • An exemplary method of making the docking device having the guard member is explained herein; however, variations can be made to achieve the embodiments illustrated and described herein.
  • the docking device having the guard member is shown herein (figures) for illustration purposes to show the product of the manufacturing procedure.
  • the coil can be provided in any one of the embodiments.
  • the compressible scaffold can be prepared from one or more shape-memory wires formed into a three-dimensional shape.
  • the scaffold can be combined with a plugging component to provide a plugging function.
  • the plugging component can be selected from a cover (e.g., external or internal) for the scaffold, absorbent members located within the compressible scaffold, or one or more compressible members (e.g., hydrophobic) in an internal space within the scaffold.
  • the plugging component can be combined with the scaffold before or after the scaffold is coupled with the coil.
  • the combination of the plugging component and the compressible scaffold provides the compressible plug, which can be used for the plugging of fluid at the medial commissure.
  • the compressible plug can be coupled to the coil by any stitching with sutures (e.g., as described herein for any stitching), or a clip, or a wrapping tape, or other fastening means to couple the plug to the coil.
  • the compressible plug can be attached to the coil of the docking device.
  • the cover and/or the scaffold of the compressible plug can be attached to the coil via one or more sutures, loop stiches, wraps, or other fastening feature.
  • the compressible plug may be directly bonded together (e.g., adhesive, welding, brazing, etc.), or placed adjacent and wrapped together with a wrapping cover.
  • the compressible plug Before implanting the docking device, the compressible plug can be retained within a dock sleeve (for example, the dock sleeve 55).
  • the guard member retained within the dock sleeve can remain in a radially compressed state.
  • the compressible plug can be radially compressed so that the body shapes to extend along the coil and body molded to the coil to be parallel to the coil.
  • any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat/thermal, pressure, steam, radiation, and/or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method.
  • heat/thermal sterilization include steam sterilization and autoclaving.
  • radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam.
  • chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example.
  • FIG. 12 shows the docking device 500 being implanted into the mitral valve so that the compressible plug 210 is located at a medial commissure 502 and the guard member 104 is on the left atrium side by an atrial wall 504, with the proximal coil region 102p extending into the left atrium 18.
  • the compressible plug 210 is illustrated without the pluggable component to illustrate how the scaffold forms to form a plug at the medial commissure 502.
  • the scaffold is extended in the deployed orientation so that the compressible plug 210 provides a plug over the medial commissure of the mitral valve anatomy, which can block PVL.
  • FIG. 13A shows a docking device being implanted with the compressible plug body 402 being shown with the plug scaffold 400 for illustration purposes.
  • the illustration is without the plugging component in order to illustrate the implantation with respect to the scaffold.
  • the plug scaffold 400 includes the plug body 402 and the plug plate 406, which has been inserted through the valve at the medial commissure.
  • the plug plate 406 is not viewable in FIG. 13 A because it extends down through the medial commissure, such that it is within the medial commissure or protruding out of the other end of the medial commissure into the left ventricle. Accordingly, only the plug back body 402 is shown as the throat and plate are extended through the medial commissure.
  • FIG. 13A shows the clockwise rotation of the docking device with the coil 102, which pulls on the plug scaffold 400 to elongate, but the plug plate is extended through the medial commissure.
  • the plug scaffold 400 has the shape of FIGS. 11A and 1 IB with the plug back 402 and plug plate 406.
  • FIG. 13B shows the counterclockwise rotation of the docking device with the coil 102 so that the plug back 402 is pressed towards the medial commissure to compress the compressible plug.
  • This shows the plug back 402 plugging the top of the medial commissure with the throat and plug plate extending through the medial commissure.
  • the braid of the scaffold of the compressible plug is configured such that the diameter of the compressible plug increases when it becomes axially compressed, as it is in Fig 13B.
  • the plug scaffold 400 has the shape of FIGS. 11A and 1 IB with the plug back 402 and plug plate 406. Accordingly, the implantation of the compressible plug with the plate body extending through the medial commissure allows for clocking the coil either clockwise or counterclockwise.
  • the docking device can be implanted as known, with the added features of the compressible plug being located at the medial commissure.
  • a single body compressible plug may be used on a top of the medial commissure; however, the compressibility and shape-memory allows for a portion of the plug to extend into the medial commissure.
  • the compressible plug with two body portions can be used to extend one of the body portions through the medial commissure. As such, the compressible plug can be at the medial commissure to inhibit PVL.
  • this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.
  • Example 1 A docking device for securing a prosthetic valve at a native valve, the docking device comprising: a coil comprising a plurality of helical turns when in a deployed orientation; and a compressible plug attached to the coil by being coupled to at least a portion of a helical turn thereof.
  • the compressible plug is movable between a radially compressed state in a delivery orientation and a radially expanded state in the deployed orientation.
  • the compressible plug includes a compressible scaffold formed from a shape-memory material.
  • the compressible plug is configured to provide a liquid plugging function, so as to form a plug and inhibit liquid leakage.
  • the compressible plug is configured to provide a liquid plugging function.
  • the compressible plug can be formed of braided or woven wires that are tightly associated to inhibit any gaps or interstitial spaces between the fibers that are woven or braided.
  • the compressible plug can include a plugging component operably coupled with the compressible scaffold to provide a liquid plugging function to the compressible plug.
  • the pluggable component can be an external cover, an internal cover, an internal sheet, absorbent members, compressible members, hydrophobic members, or other elements to provide a leak inhibiting plug.
  • a docking device for securing a prosthetic valve at a native valve comprising: a coil comprising a plurality of helical turns when in a deployed orientation; a guard member attached to the coil by being coupled to at least a portion of a helical turn thereof, wherein the guard member includes a scaffold with a spine and a plurality of arms extending from the spine, wherein the plurality of arms are coupled to a flap, wherein the guard member is movable between a radially compressed state in a delivery orientation and a radially expanded state in the deployed orientation; and a compressible plug attached to the coil by being coupled to at least a portion of a helical turn thereof, wherein the compressible plug is movable between a radially compressed state in a delivery orientation and a radially expanded state in the deployed orientation, wherein the compressible plug includes: a compressible scaffold formed from a shapememory material; and the compressible plug is configured for providing a plugging function, such as the
  • Example 3 The docking device of Examples 1-2, wherein the compressible scaffold includes a body formed by one or more wires of the shape-memory material that is shaped into a three-dimensional expanded shape.
  • Example 4 The docking device of Examples 1 -3 , wherein the one or more wires are woven, braided, wound, a mesh, or associated together to form the body having the three-dimensional expanded shape.
  • Example 5 The docking device of Examples 1-4, wherein the shape-memory material includes a nickel titanium alloy.
  • Example 6 The docking device of Examples 1-5, wherein the three- dimensional expanded shape of the compressible scaffold has one or more of: a hollow external shell; a first end that is tapered; a second end that is partially toroidal; a second end that with a flattened face; a second end with a sharply tapered face; a second end that has an angled leading edge; an intermediate narrowing section to a narrowed throat; an intermediate narrowed throat; an intermediate expanding section from the narrowed throat; a three-dimensional first body portion and a three-dimensional second body portion; a three-dimensional first body portion with a first tapered end and an intermediate narrowing section, an intermediate narrowed throat, and a three-dimensional second body portion with an intermediate expanding section, an expanded end, and with an narrowed end face; a disc shape; a wing shape; hollow internal core; an internal space between a hollow external shell and hollow internal core; a hollow internal core formed as a conduit with an internal lumen; or a second end that is tape
  • Example ? The docking device of Examples 1-6, wherein the three- dimensional expanded shape of the compressible scaffold includes a conical body region with a tapered first end region and rounded second end region.
  • Example 8 The docking device of Examples 1-6, wherein the three- dimensional expanded shape of the compressible scaffold includes a conical body region with a tapered first end region and a tubular region to a second end.
  • Example 9 The docking device of Examples 1-6, wherein the three- dimensional expanded shape of the compressible scaffold includes a conical body portion with a tapered first end and an angled leading edge rounded to an angled face, wherein the angled face is flat or curved.
  • Example 10 The docking device of Examples 1-6, wherein the three- dimensional expanded shape of the compressible scaffold includes: a conical body portion with a tapered first end and an angled leading edge rounded to an angled face, and a disc portion having two disc faces and an annular region therebetween.
  • Example 11 The docking device of Examples 1-6, wherein the three- dimensional expanded shape of the compressible scaffold includes a disc portion having two disc vases and an annular region therebetween.
  • Example 12 The docking device of Examples 1-6, wherein the three- dimensional expanded shape of the compressible scaffold includes at least one lateral wing having a wing top surface and wing bottom surface.
  • Example 13 The docking device of Examples 1-12, wherein the three- dimensional expanded shape of the compressible scaffold includes a conical body with a hollow outer shell and hollow inner core defining a lumen.
  • Example 14 The docking device of Examples 1-13, wherein the compressible plug and coil are coupled by at least one of: the compressible plug includes a first tapered end coupled with the coil; the coil passes through the lumen of the compressible plug; the compressible plug includes a side region between a first and second end that is coupled with the coil; or the compressible plug includes a first tapered end and second end coupled with the coil.
  • Example 15 The docking device of Examples 1-14, wherein a braid angle of the one or more wires of the compressible scaffold narrows when the compressible plug is longitudinally elongated.
  • Example 16 The docking device of Examples 1-15, wherein a braid angle of the one or more wires of the compressible scaffold expands when the compressible plug is longitudinally compressed.
  • Example 17 The docking device of Examples 1-16, wherein: the coil passes through a lumen of the compressible plug; or the compressible plug hangs off of an attachment point on the coil.
  • Example 18 The docking device of Examples 1-17, wherein the compressible plug includes a first end coupled with the coil.
  • Example 19 The docking device of Examples 1-17, wherein the coil passes through an internal lumen of the compressible plug.
  • Example 20 The docking device of Examples 1-17, wherein the compressible plug includes a side attached to the coil.
  • Example 21 The docking device of Examples 1-17, wherein the compressible plug includes a first and a second end coupled to the coil.
  • Example 22 The docking device of Examples 1-21, wherein the plugging component of the compressible plug includes a cover on or around the compressible scaffold.
  • Example 23 The docking device of Examples 1-22, wherein the cover forms a fluid tight covering surface on or around the compressible scaffold.
  • Example 24 The docking device of Examples 1-23, wherein the cover is waterproof.
  • Example 25 The docking device of Examples 1-24, wherein the cover is: coupled to a surface the compressible scaffold so as to conform with the three-dimensional shape; formed into a sack retaining the compressible scaffold therein; formed into a sheet within the compressible scaffold; formed into a bladder within the compressible scaffold; or formed into an internal surface covering within the compressible scaffold.
  • Example 26 The docking device of Examples 1-25, wherein the cover is over an outer surface of the compressible scaffold.
  • Example 27 The docking device of Examples 1-26, wherein the cover is under an internal surface of an internal space of the compressible scaffold.
  • Example 28 The docking device of Examples 1-27, wherein the cover is formed of a material expanded polytetrafluoroethylene (ePTFE), polytetrafluoroethylene (PTFE), thermoplastic polyurethane, or silicone.
  • ePTFE expanded polytetrafluoroethylene
  • PTFE polytetrafluoroethylene
  • thermoplastic polyurethane or silicone.
  • Example 29 The docking device of Examples 1-28, wherein the plugging component includes one or more fluid absorbent members located within the internal space of the compressible scaffold.
  • Example 30 The docking device of Examples 1-29, wherein the plugging component includes one or more compressible members in the internal space of the compressible scaffold.
  • Example 31 The docking device of Examples 1-30, wherein the compressible plug is configured for fitting, at least partially within, or extending through a medial commissure of a native heart valve.
  • Example 32 The docking device of Examples 1-31, wherein the compressible plug includes an atrial portion configured to be retained in a left atrium, and a ventricle portion configured to extend toward or into the ventricle through the medial commissure.
  • Example 33 The docking device of Examples 1-31, wherein a second end of the compressible plug is free to move relative to the coil.
  • Example 34 The docking device of Examples 1-33, wherein a narrowed throat region separates an atrial portion from a ventricle portion of the compressible plug.
  • Example 35 The docking device of Examples 1-34, further comprising at least one marker band coupled with the compressible plug.
  • Example 36 The docking device of Examples 1 and 3-35, wherein the coil omits a guard member.
  • Example 37 The docking device of Examples 1-35, wherein the coil includes the guard member.
  • Example 38 The docking device of Example 32, where when the compressible plug is in a radially compressed state, the one or more wires are radially compressed against the coil in the delivery orientation so that a cross-sectional profile of the docking device includes a diameter that is smaller than a predefined threshold diameter.
  • Example 39 The docking device of Example 38, wherein the predefined threshold diameter ranges from about 2 mm to about 3 mm.
  • Example 40 The docking device of Example 38, wherein when the compressible plug moves from the radially compressed state of the delivery orientation to the radially expanded state of the deployed orientation, the compressible scaffold extends radially outwardly relative to the coil by the shape-memory material.
  • Example 41 The docking device of Examples 1-40, wherein the compressible plug is connected to the coil via one or more sutures.
  • Example 42 The docking device of Examples 1-25, wherein when the compressible plug is in the deployed orientation at the native valve, one or more compressible plug regions overlay or press against or extend at least partially through a medial commissure of a native heart chamber.
  • Example 43 The docking device of Example 42, wherein the native valve is a mitral valve.
  • Example 44 The docking device of Examples 1-43, wherein the cover of the compressible plug includes at least one layer of a biocompatible material coupled to the compressible scaffold.
  • Example 45 The docking device of Example 44, wherein the biocompatible material is flexible so as to be capable of being folded in the delivery orientation and expanded in the deployed orientation.
  • Example 46 The docking device of Examples 44-45, wherein the biocompatible material is porous and configured for cellular ingrowth.
  • Example 47 The docking device of Examples 1-46, wherein the cover is formed of at least one sheet of fabric formed by weaving, knitting, crocheting, braiding, laminating, electrospinning, extrusion, or bonding fibers together, wherein the fibers are biocompatible.
  • Example 48 The docking device of Examples 1-47, wherein the cover is formed of at least one sheet of material that is polymeric in a form of a membrane, film, plastic sheet, or foil, wherein the sheet material is biocompatible.
  • Example 49 The docking device of Example 48, wherein the sheet material is expanded polytetrafluoroethylene (ePTFE), polytetrafluoroethylene (PTFE), thermoplastic polyurethane, or silicone.
  • ePTFE expanded polytetrafluoroethylene
  • PTFE polytetrafluoroethylene
  • thermoplastic polyurethane or silicone.
  • Example 50 The docking device of Examples 1-49, wherein the three- dimensional expanded shape has a maximum diameter that ranges from about 5 mm to about 25 mm, from about 10 mm to about 20 mm, or about 14 mm to about 16 mm.
  • Example 51 The docking device of Examples 1-50, wherein the three- dimensional expanded shape of the compressible plug has a length that ranges from about 3 mm to about 50 mm, from about 8 mm to about 40 mm, or about 15 mm to about 30 mm, or about 20 mm.
  • Example 52 A method for making the docking device of Examples 1-51, the method comprising: forming a plurality of wires of a shape-memory material into the compressible scaffold; attaching a cover to the compressible scaffold to form the compressible plug; obtaining the coil; and coupling the compressible plug to the coil.
  • Example 53 The method of Example 52, further comprising: forming a body with one or more wires of the shape-memory material; and shaping the body into a three- dimensional expanded shape.
  • Example 54 The method of Examples 52-53, further comprising forming the body by weaving, braiding, wind, forming a mesh, or associating the one or more wires together to form the body having the three-dimensional expanded shape.
  • Example 55 The method of Examples 52-54, further comprising forming the three-dimensional expanded shape of the compressible scaffold to have one or more of: a hollow external shell; a first end that is tapered; a second end that is partially toroidal; a second end that with a flattened face; a second end with a sharply tapered face; a second end that has an angled leading edge; an intermediate narrowing section to a narrowed throat; an intermediate narrowed throat; an intermediate expanding section from the narrowed throat; a three-dimensional first body portion and a three-dimensional second body portion; a three-dimensional first body portion with a first tapered end and an intermediate narrowing section, an intermediate narrowed throat, and a three-dimensional second body portion with an intermediate expanding section, an expanded end, and with an narrowed end face; a disc shape; a wing shape; hollow internal core; an internal space between a hollow external shell and hollow internal core; a hollow internal core formed as a conduit with an internal lumen; or a second end that
  • Example 56 The method of Example 52, further comprising enclosing the compressible scaffold within a cover to form the guard member of the docking device.
  • Example 57 The method of Examples 52-56, further comprising inserting absorbent members into an interior space of the compressible scaffold.
  • Example 58 The method of Examples 52-57, further comprising inserting compressible members into an interior space of the compressible scaffold.
  • Example 59 The method of Example 58, wherein the compressible members are hydrophobic, and when compressed forma hydrophobic barrier.
  • Example 60 The method of Examples 52-59, further comprising attaching the compressible plug to the coil of the docking device by stitching the compressible plug to a coil cover member.
  • Example 61 The method of Examples 52-60, comprising stitching the compression plug to a retention member of the coil, wherein the coil includes a coil core, a tubular cover member over the coil core, and the retention member as a tube over the tubular cover member.
  • Example 62 The method of Examples 52-61, further comprising forming a marker band onto one or more of the compressible plug or coil.
  • Example 63 The method of Examples 52-62, further comprising: wrapping, braiding, winding, or coupling a cover wrap around the compressible scaffold; and attaching at least one end of the cover wrap onto the coil.
  • Example 64 A method of configuring a docking device for delivery to a native valve, the method comprising: providing the docking device of Examples 1-51; compressing the compressible plug and optionally the guard member by compressing the compressible scaffold into the delivery orientation; and inserting the compressible plug and optionally the guard member in the delivery orientation into a dock sleeve of a dock delivery system.
  • Example 65 The method of Example 64, further comprising inserting the coil into the dock sleeve.
  • Example 66 A method of implanting a docking device into a native valve, the method comprising: providing the docking device of Examples 1-51; delivering the docking device to a native valve while the docking device is in a delivery orientation; deploying the coil of the docking device at an annulus of the native valve; and deploying the compressible member into the deployed orientation at a position at the native valve so that the guard member overlays or presses against or at least partially penetrates a medial commissure of a native valve and/or native heart chamber associated with the native valve.
  • Example 67 The method of Example 66, wherein when the compressible plug is in the deployed orientation at a mitral valve, the compressible plug forms at least partially compressed plug at the medial commissure.
  • Example 68 The method of Examples 66-67, wherein when the compressible plug is in the deployed orientation at a mitral valve, the compressible plug overlays or presses against an anterior leaflet or posterior leaflet or left atrium region thereof.
  • Example 69 The method of Example 66-68, wherein the coil remains in a substantially straight configuration in the delivery orientation when delivering the docking device and the coil member moves to a helical configuration after the docking device is deployed.
  • Example 70 The method of Examples 66-69, wherein the compressible plug remains in the delivery orientation when delivering the docking device and moves to the deployed orientation after the docking device is deployed.
  • Example 71 The method of Examples 66-70, wherein delivering the docking device comprises retaining the docking device within a dock sleeve, wherein deploying the docking device comprises moving the docking device out of the dock sleeve.
  • Example 72 The method of Examples 66-71, wherein deploying the docking device comprises removing a delivery sleeve from the coil and compressible plug while at the native valve.
  • Example 73 The method of Examples 66-72, comprising clocking the coil clockwise and/or clockwise during installation of the docking device.
  • Example 74 The method of Examples 66-73, comprising clocking the coil counterclockwise to compress the compressible plug.
  • Example 75 The method of Examples 66-74, comprising clocking the coil clockwise to reduce compression of the compressible plug.
  • Example 76 A method of implanting a prosthetic valve, comprising: providing the docking device of Examples 1-51; delivering the docking device to a native valve; deploying the docking device at an annulus of the native valve so that the compressible plug expands into the deployed orientation at a position at the native valve so that the compressible plug overlays or presses against or at least partially penetrates the medial commissure of the native valve and/or native heart chamber associated with the native valve; and deploying a prosthetic valve within the docking device, wherein the coil remains in a substantially elongate delivery orientation (e.g., no coiled, straight or with some curvature for rounding physiological features) when delivering the docking device and moves to a helical configuration after the docking device is in the deployed orientation, wherein the compressible plug remains in a folded delivery orientation when delivering the docking device and moves to an unfolded deployed orientation after the docking device is deployed.
  • a substantially elongate delivery orientation e.g., no coiled, straight or with
  • Example 77 The docking device of Examples 2-35 and 37-51, wherein when the guard member is in the radially compressed state, the plurality of arms and the flap are radially compressed against the coil in the delivery orientation so that a cross-sectional profile of the docking device includes a diameter that is smaller than a predefined threshold diameter.
  • Example 78 The docking device of Examples 2-35, 37-51, and 77, wherein the predefined threshold diameter ranges from about 2 mm to about 3 mm.
  • Example 79 The docking device of Examples 2-35, 37-51, and 77-28, wherein when the guard member moves from the radially compressed state of the delivery orientation to the radially expanded state of the deployed orientation, the guard member extends radially outwardly relative to the coil by the arms rotating outwardly and extending the flap.
  • Example 80 The docking device of Examples 2-35, 37-51, and 77-79, wherein when the guard member is in the radially expanded state in the deployed orientation, the plurality of arms and flap extend radially outward away from the coil and circumferentially along a portion of the coil.
  • Example 81 The docking device of Examples 2-35, 37-51, and 80, wherein the flap defines an inner edge that is coupled to the coil, wherein the inner edge of the flap has an arc angle that is greater than 180 degrees.
  • Example 82 The docking device of Examples 2-35, 37-51, and 81, wherein the arc angle ranges from about 240 degrees to about 360 degrees.
  • Example 83 The docking device of Examples 2-35, 37-51, and 77-82, wherein the number of arms range from about three to about eight.
  • Example 84 The docking device of Examples 2-35, 37-51, and 83, wherein the number of arms ranges from about four to about six.
  • Example 85 The docking device of Examples 2-35, 37-51, and 77-84, wherein the plurality of arms have substantially the same length.
  • Example 86 The docking device of Examples 2-35, 37-51, and 77-85, wherein the guard member includes at least one arm forming at least one lobe by having both ends of the respective at least one arm coupled to the spine.
  • Example 87 The docking device of Examples 2-35, 37-51, and 77-86, wherein the at least one lobe includes a terminal lobe a terminal position of the spine.
  • Example 88 The docking device of Examples 2-35, 37-51, and 77-87, wherein the terminal position is a trailing position of the spine with curvature of the plurality of arms oriented toward the trailing position.
  • Example 89 The docking device of Examples 2-35, 37-51, and 77-88, wherein for each arm, a base portion of the respective arm is attached to the spine and a head portion extends radially outwardly relative to the base portion from the spine when the guard member is in the radially expanded state in the deployed orientation.
  • Example 90 The docking device of Examples 2-35, 37-51, and 77-89, wherein each arm extends at an angle relative to the spine when the guard member is in the radially expanded state in the deployed orientation, wherein the angle is less than or about 80 degrees, less than or about 70 degrees, less than or about 60 degrees, less than or about 50 degrees, less than or about 40 degrees, or less than or about 30 degrees.
  • Example 91 The docking device of Examples 2-35, 37-51, and 90, wherein the plurality of arms extend at the angle relative to the spine when the guard member is in the radially expanded state in the deployed orientation, wherein the angle for each arm is within about 10 degrees from each other.
  • Example 92 The docking device of Examples 2-35, 37-51, and 77 , wherein when guard member is in the radially expanded state in the deployed orientation the flap extends from the coil with a radially expanded dimension of about 4 mm to about 30 mm, from about 6 mm to about 25 mm, or about 10.5 mm.
  • Example 93 The docking device of Examples 2-35, 37-51, and 77-92, wherein each arm of the plurality of arms has a length from the spine to a tip of about 4 mm to about 30 mm, from about 8 mm to about 25 mm, or about 10.5 mm.
  • Example 94 The docking device of Examples 2-35, 37-51, and 77-93, wherein the one or more arms are spaced apart on the spine with about equal distance when the guard member is in the radially expanded state in the deployed orientation, where gaps between the arms define panels of the flap.
  • Example 95 The docking device of Examples 2-35, 37-51, and 77-94, wherein the guard member is connected to the coil via one or more sutures.
  • Example 96 The docking device of Examples 2-35, 37-51, and 77-95, wherein the guard member is stitched to a cover member of the coil via the one or more sutures.
  • Example 97 The docking device of Examples 2-35, 37-51, and 77-96, wherein when the guard member is stitched to a retention member of the coil, wherein the coil includes a coil core, a tubular cover member over the coil core, and the retention member as a tube over the tubular cover member.
  • Example 98 The docking device of Examples 2-35, 37-51, and 77-97, wherein each arm is within a sleeve, wherein the sleeve is either coupled with the flap or formed from a sleeve sheet stitched to the flap to form the sleeve.
  • Example 99 The docking device of Examples 2-35, 37-51, and 77-98, wherein each arm is loop stitched to the flap.
  • Example 100 The docking device of Examples 2-35, 37-51, and 77-99, wherein the flap is stitched to the spine.
  • Example 101 The docking device of Examples 2-35, 37-51, and 77-100, wherein when the guard member is in the deployed orientation at the native valve, one or more proximal arms overlay or press against a first portion of a native heart chamber and one or more distal arms overlay or press against a second portion of the native heart chamber that is about opposite to the first portion.
  • the native valve can be a mitral valve, wherein the first portion comprises an anterior leaflet or posterior leaflet of the mitral valve, and the second portion comprises the posterior leaflet of the mitral valve when the first portion comprises the anterior leaflet and comprises the anterior leaflet of the mitral valve when the first portion comprises the posterior leaflet.
  • Example 102 The docking device of Examples 2-35, 37-51, and 77-101, wherein when the guard member is in the deployed orientation at a mitral valve, the flap overlays or presses against a posterior leaflet or left atrium region thereof.
  • Example 103 The docking device of Examples 2-35, 37-51, and 77-102, wherein when the guard member is in the deployed orientation at a mitral valve, the flap overlays or presses against an anterior leaflet or left atrium region thereof.
  • Example 104 The docking device of Examples 2-35, 37-51, and 77-103, wherein when the guard member is in the deployed orientation at a mitral valve, the flap overlays or presses against an anterior leaflet and posterior leaflet or left atrium region thereof.
  • Example 105 The docking device of Examples 2-35, 37-51, and 77-104, wherein the scaffold comprises a shape memory material.
  • Example 106 The docking device of Example 2-35, 37-51, and 77-105, wherein the shape memory material comprises nickel titanium alloy.
  • Example 107 The docking device of Examples 2-35, 37-51, and 77-106, wherein the flap includes at least one layer of a biocompatible material coupled to the scaffold.
  • Example 108 The docking device of Examples 2-35, 37-51, and 107, wherein the biological material is flexible so as to be capable of being folded in the delivery orientation and expanded in the deployed orientation.
  • Example 109 The docking device of Examples 2-35, 37-51, and 108-109, wherein the biological material is porous and configured for cellular ingrowth.
  • Example 110 The docking device of Examples 2-35, 37-51, and 77-109, wherein each arm has a head at a terminal end opposite of the spine, wherein each head includes a rounded shape.
  • Example 111 The docking device of Examples 2-35, 37-51, and 110, wherein each head includes a teardrop shape with a rounded distal end.
  • Example 112 The docking device of Examples 2-35, 37-51, and 77-111, wherein each arm includes a bend so that each arm is either bent clockwise or counter-clockwise.
  • Example 113 The docking device of Example 2-35, 37-51, and 112, wherein the bend turns a distal region of the arm to be about parallel with the with the spine, wherein the distal region of each arm has an angle with respect to the spine to be less then or about 10 degrees.
  • Example 114 The docking device of Examples 2-35, 37-51, and 110-113, wherein each head of each arm is retained within a sleeve that is coupled with the flap of the guard member.
  • Example 115 The docking device of Examples 2-35, 37-51, and 77-114, wherein the flap is formed of at least one sheet of fabric formed by weaving, knitting, crocheting, or bonding fibers together, wherein the fibers are biocompatible. Additional examples include braiding, laminating (e.g., for polymeric coverings), electrospinning (ePTFE, etc), and extrusion (ePTFE), as well as other related methods.
  • ePTFE electrospinning
  • ePTFE extrusion
  • Example 116 The docking device of Examples 2-35, 37-51, and 77-115, wherein the flap is formed of at least one sheet of material that is polymeric in a form of a membrane, film, plastic sheet, or foil, wherein the sheet material is biocompatible.
  • Example 117 The docking device of Examples 2-35, 37-51, and 116, wherein the sheet material is expanded polytetrafluoroethylene (ePTFE).
  • ePTFE expanded polytetrafluoroethylene
  • Example 118 The docking device of Examples 2-35, 37-51, and 77-117, wherein the flap comprises a peripheral lip configured as an edge proctor coupled to the flap, wherein the edge protector wraps around a distal region of the arms from a top surface to a bottom surface of the flap.
  • Example 119 The docking device of Examples 2-35, 37-51, and 118, wherein the edge protector is formed of a fabric or a polymeric sheet.
  • Example 120 The docking device of Examples 2-35, 37-51, and 77-119, wherein the scaffold includes a uniform thickness that ranges from about 0.10 mm to about 0.5 mm.
  • Example 121 The docking device of Examples 2-35, 37-51, and 120, wherein each arm has a width that ranges from about 0.10 mm to about 0.30 mm, wherein the width is orthogonal with the thickness.
  • Example 122 The docking device of Examples 2-35, 37-51, and 120-121, wherein each arm has a length that ranges from aboutlO mm to about 60 mm.
  • Example 123 The docking device of Examples 2-35, 37-51, and 77-122, wherein the flap has a dimension from the coil that ranges from about 30 mm to about 70 mm, from about 40 mm to about 60 mm, or about 45 mm to about 55 mm.
  • Example 124. The docking device of Examples 2-35, 37-51, and 77-123, wherein the flap has a dimension from coil to edge boundary that ranges from about 4 mm to about 30 mm, from about 6 mm to about 20 mm, or about 8 mm to about 10 mm, or about 10.5 mm.
  • Example 125 The docking device of Examples 2-35, 37-51, and 77-124, wherein an edge protector on a peripheral edge of the guard member is a same material of the flap that is folded over the head of the arms.
  • Example 126 The docking device of Examples 2-35, 37-51, and 77-125, wherein a base portion of each arm has a width of about 0.1 mm and a region adjacent to the head portion of each arm has a width of about 0.25 mm.
  • Example 127 The docking device of Examples 2-35, 37-51, and 77-126, wherein the guard member includes a marker band.
  • Example 128 The docking device of Example 2-35, 37-51, and 127, wherein the marker band is crimped onto the guard device.
  • Example 129 The docking device of Examples 2-35, 37-51, and 128, wherein the marker band is crimped onto the guard device and coil.
  • Example 130 The docking device of Examples 2-35, 37-51, and 77-129, further comprising a covering wrap that is wrapped around the coil and spine, and a marker band crimp at each end of the covering wrap.
  • Example 131 The docking device of Examples 2-35, 37-51, and 77-130, wherein the spine has an arc in a relaxed state, wherein the arc is at least a portion of a circumference having a diameter, wherein the diameter ranges from about 0.29 mm to about 40 mm, from about 0.31 mm to about 0.38 mm, or about 33 mm to about 35 mm.
  • Example 132 The docking device of Examples 2-35, 37-51, and 77-131, wherein the coil includes a cover having a first cover region outside of the guard member that is thicker than a second cover region at the guard member.
  • Example 133 The docking device of Examples 2-35, 37-51, and 77-132, wherein the coil includes a cover having: a first cover region outside of the guard member with a thickness of about 1.6 mm to 2.2 mm or about 1.9 mm; and a second cover region at the guard member with a thickness of about 1.0 mm to about 1.6 mm or about 1.3 mm.
  • Example 134 The docking device of Examples 2-35, 37-51, and 77-133, wherein the guard member includes a cover substantially enclosing the scaffold, wherein the cover forms the flap.
  • Example 135. The docking device of Examples 2-35, 37-51, and 134, wherein the cover is formed by two cover sheets coupled together with the scaffold therein.
  • Example 136 A method for making the docking device of Examples 2-35, 37-51, and 77-135, the method comprising: obtaining the scaffold comprising the spine and a plurality of arms connected to and extending radially outwardly from the spine; coupling the scaffold to the flap to form the guard member; obtaining the coil; and coupling the guard member to the coil.
  • Example 137 The method of Example 136, further comprising enclosing the scaffold within a cover of the flap to form the guard member of the docking device.
  • Example 138 The method of Examples 136-137, wherein the obtaining the scaffold comprises cutting a substrate to form the spine and the plurality of arms.
  • Example 139 The method of Example 138, wherein the substrate comprises a nickel-titanium alloy (e.g., Nitinol) sheet, and wherein the cutting comprises laser cutting the Nitinol sheet.
  • Nitinol nickel-titanium alloy
  • Example 140 The method of Examples 136-139, further comprising stacking two fabric layers together and cutting the two fabric layers using a mold placed over the two fabric layers to create the cover, wherein an outer periphery of the mold defines a rounded shape of the scaffold, and wherein an inner periphery of the mold defines a shape of the spine of the scaffold.
  • Example 141 The method of Examples 136-140, wherein cutting the two fabric layers comprises moving a heated member (e.g., soldering iron) along the outer periphery of the mold so that the two fabric layers are heat-cut along the outer periphery of the mold and sealed together to form an outer edge of the cover.
  • a heated member e.g., soldering iron
  • Example 142 The method of Example 141, wherein enclosing the scaffold comprises inserting the scaffold between the two fabric layers through an opening that is located radially inwardly of the inner periphery of the mold, wherein the scaffold inserted between the two fabric layers is positioned so that the plurality of arms are aligned with the outer edge of the cover.
  • Example 143 The method of Example 142, wherein enclosing the wireframe further comprises moving the heated member (e.g., soldering iron) along the inner periphery of the mold so that the two fabric layers are heat-cut along the inner periphery the mold and sealed together to form an inner edge of the cover, wherein the spine of the scaffold extends along the inner edge of the cover.
  • Example 144 The method of any one of Examples 136-143, further comprising connecting the scaffold to the flap via a plurality of sutures.
  • Example 145 The method of Example 144, wherein at least some of the sutures extend across one or more arms or one or more spine regions of the scaffold.
  • Example 146 The method of Examples 144-145, wherein at least some of the sutures stitch a sleeve for each arm to the flap.
  • Example 147 The method of any one of Examples 136-146, further comprising attaching the guard member to a coil of the docking device by stitching the flap to a coil cover member.
  • Example 148 The method of any one of Examples 136-147, comprising stitching the guard member to a retention member of the coil, wherein the coil includes a coil core, a tubular cover member over the coil core, and the retention member as a tube over the tubular cover member.
  • Example 149 The method of Example 146-148, further comprising forming the sleeve for each arm by cutting a fabric sheet into a shape of the sleeve and stitching the sleeve-shaped fabric sheet in the shape of the sleeve with the flap.
  • Example 150 The method of Examples 146-149, further comprising forming the sleeve by forming a tube that fits around the respective arm, and stitching the tubular sleeve to the flap.
  • Example 151 The method of Examples 136-150, further comprising forming at least one lobe on the scaffold, wherein the lobe includes a lobe arm connected at both ends to the spine.
  • Example 152 The method of Examples 136-151, further comprising forming a head on each arm of the scaffold.
  • Example 153 The method of Example 152, wherein forming the head includes cutting the head with the respective arms from a sheet.
  • Example 154 The method of Example 152, wherein forming the head includes: cutting the arms from a sheet; and bending a distal end of the arm back onto itself to form a loop with a rounded end.
  • Example 155 The method of Examples 136-154, further comprising forming an edge protector on a peripheral lip of the flap.
  • Example 156 The method of Examples 136-155, further comprising forming a marker band onto the guard member.
  • Example 158 The method of one of Examples 136-157, further comprising: wrapping a cover wrap around a core of the coil and the spine of the scaffold; and crimping or otherwise attaching each end of the cover wrap onto the core and spine.
  • Example 159 A method of configuring a docking device for delivery to a native valve, the method comprising: providing the docking device of one of the Examples 1-51; compressing the guard member by compressing the arms to fold the flap into the delivery orientation; and inserting the guard member in the delivery orientation into a dock sleeve of a dock delivery system.
  • Example 160 The method of Example 159, further comprising inserting the coil into the dock sleeve.
  • Example 161 A method of implanting a docking device into a native valve, the method comprising: providing the docking device of one of Examples 1-51; delivering the docking device to a native valve while the docking device is in a delivery orientation; deploying the coil of the docking device at an annulus of the native valve; and deploying the guard member into the deployed orientation at a position at the native valve so that the guard member overlays or presses against the native valve and/or native heart chamber associated with the native valve.
  • Example 162 The method of Example 161, further comprising deploying the guard member results in rotation of the plurality of arms and radial expansion of the flap.
  • Example 163 The method of one of Examples 161-162, wherein when the guard member is in the deployed orientation at the native valve, one or more proximal arms overlay or press against a first portion of a native heart chamber and one or more distal arms overlay or press against a second portion of the native heart chamber that is about opposite to the first portion.
  • Example 164 The method of Example 163, wherein the native valve is a mitral valve, wherein the first portion comprises an anterior leaflet or posterior leaflet of the mitral valve, and the second portion comprises the posterior leaflet of the mitral valve when the first portion comprises the anterior leaflet and comprises the anterior leaflet of the mitral valve when the first portion comprises the posterior leaflet.
  • Example 165 The method of one of Example 162-164, wherein when the guard member is in the deployed orientation at a mitral valve, the flap overlays or presses against a posterior leaflet or left atrium region thereof.
  • Example 166 The method of one of Example 161-165, wherein when the guard member is in the deployed orientation at a mitral valve, the flap overlays or presses against an anterior leaflet or left atrium region thereof.
  • Example 167 The method of one of Example 161-166, wherein when the guard member is in the deployed orientation at a mitral valve, the flap overlays or presses against an anterior leaflet and posterior leaflet or left atrium region thereof.
  • Example 168 The method of one of Examples 161-167, wherein the coil remains in a substantially straight configuration in the delivery orientation when delivering the docking device and a coil member moves to a helical configuration after the docking device is deployed.
  • Example 169 The method of one of Examples 161-168, wherein the guard member remains in the delivery orientation when delivering the docking device and moves to the deployed orientation after the docking device is deployed.
  • Example 170 The method of one of Example 161-169, wherein delivering the docking device comprises retaining the docking device within a dock sleeve, wherein deploying the docking device comprises moving the docking device out of the dock sleeve.
  • Example 171 The method of any one of Examples 161-170, wherein deploying the docking device comprises removing a delivery sleeve from the coil and guard member while at the native valve.
  • Example 172 A method if implanting a prosthetic valve, comprising: providing the docking device of one of Example 1-51; delivering the docking device to a native valve; deploying the docking device at an annulus of the native valve so that the guard member expands into the deployed orientation at a position at the native valve so that the guard member overlays or presses against the native valve and/or native heart chamber associated with the native valve; and deploying a prosthetic valve within the docking device, wherein the coil remains in a substantially straight delivery orientation when delivering the docking device and moves to a helical configuration after the docking device is in the deployed orientation, wherein the guard member remains in a folded delivery orientation when delivering the docking device and moves to an unfolded deployed orientation after the docking device is deployed.
  • Example 173 A method comprising sterilizing the docking device or guard member of any example herein, particularly any one of Examples 1-51.
  • Example 174 A method of treating a heart on a simulation, the method comprising: deploying a docking device at a target location; and deploying a prosthetic valve within the docking device; wherein the docking device is according to any one of Examples 1-51.
  • any one or more of the features of one docking device can be combined with any one or more features of another docking device.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (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 de fixation d'une prothèse valvulaire au niveau d'une valvule native. Le dispositif d'amarrage peut comprendre une bobine comprenant une pluralité de spires hélicoïdales lorsqu'elle est dans une orientation déployée. Le dispositif d'amarrage peut comprendre un bouchon compressible fixé à la bobine en étant couplé à au moins une partie d'une spire hélicoïdale de celle-ci. Le bouchon compressible est mobile entre un état comprimé radialement dans une orientation de distribution et un état déployé radialement dans l'orientation déployée. Le bouchon compressible comprend : un échafaudage compressible formé à partir d'un matériau à mémoire de forme ; et un composant d'obturation couplé de manière fonctionnelle à l'échafaudage compressible pour fournir une fonction d'obturation de liquide au bouchon compressible.
PCT/US2025/027013 2024-05-01 2025-04-30 Dispositif d'amarrage de prothèse valvulaire ayant un bouchon compressible pour atténuation de fuite périvalvulaire au niveau de la commissure médiale Pending WO2025231088A1 (fr)

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US202463641105P 2024-05-01 2024-05-01
US63/641,105 2024-05-01

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Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9155619B2 (en) 2011-02-25 2015-10-13 Edwards Lifesciences Corporation Prosthetic heart valve delivery apparatus
US20180028310A1 (en) 2016-08-01 2018-02-01 Edwards Lifesciences Corporation Prosthetic heart valve
US20180177594A1 (en) 2016-08-26 2018-06-28 Edwards Lifesciences Corporation Heart valve docking devices and systems
US20180263764A1 (en) 2016-12-20 2018-09-20 Edwards Lifesciences Corporation Systems and mechanisms for deploying a docking device for a replacement heart valve
US20180318079A1 (en) 2016-12-16 2018-11-08 Edwards Lifesciences Corporation Deployment systems, tools, and methods for delivering an anchoring device for a prosthetic valve
WO2018222799A1 (fr) 2017-05-31 2018-12-06 Edwards Lifesciences Corporation Élément d'étanchéité pour une valve cardiaque prothétique
WO2020247907A1 (fr) 2019-06-07 2020-12-10 Edwards Lifesciences Corporation Systèmes, dispositifs et procédés de traitement de valvules cardiaques
US11185406B2 (en) 2017-01-23 2021-11-30 Edwards Lifesciences Corporation Covered prosthetic heart valve
WO2022087336A1 (fr) 2020-10-23 2022-04-28 Edwards Lifesciences Corporation Dispositif d'accueil de valve prothétique
WO2023091254A1 (fr) * 2021-11-19 2023-05-25 Edwards Lifesciences Corporation Dispositif d'accueil de prothèse valvulaire
US20230255755A1 (en) * 2020-10-29 2023-08-17 Edwards Lifesciences Corporation Apparatus and methods for reducing paravalvular leakage

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9155619B2 (en) 2011-02-25 2015-10-13 Edwards Lifesciences Corporation Prosthetic heart valve delivery apparatus
US20180028310A1 (en) 2016-08-01 2018-02-01 Edwards Lifesciences Corporation Prosthetic heart valve
US20180177594A1 (en) 2016-08-26 2018-06-28 Edwards Lifesciences Corporation Heart valve docking devices and systems
US20180318079A1 (en) 2016-12-16 2018-11-08 Edwards Lifesciences Corporation Deployment systems, tools, and methods for delivering an anchoring device for a prosthetic valve
US20180263764A1 (en) 2016-12-20 2018-09-20 Edwards Lifesciences Corporation Systems and mechanisms for deploying a docking device for a replacement heart valve
US11185406B2 (en) 2017-01-23 2021-11-30 Edwards Lifesciences Corporation Covered prosthetic heart valve
WO2018222799A1 (fr) 2017-05-31 2018-12-06 Edwards Lifesciences Corporation Élément d'étanchéité pour une valve cardiaque prothétique
WO2020247907A1 (fr) 2019-06-07 2020-12-10 Edwards Lifesciences Corporation Systèmes, dispositifs et procédés de traitement de valvules cardiaques
WO2022087336A1 (fr) 2020-10-23 2022-04-28 Edwards Lifesciences Corporation Dispositif d'accueil de valve prothétique
US20230255755A1 (en) * 2020-10-29 2023-08-17 Edwards Lifesciences Corporation Apparatus and methods for reducing paravalvular leakage
WO2023091254A1 (fr) * 2021-11-19 2023-05-25 Edwards Lifesciences Corporation Dispositif d'accueil de prothèse valvulaire

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