Cardiac implants

Abstract

An expandable device (200c) comprises a skirt (340c) circumscribing at least a portion of the device. A delivery tool (120d) has a distal portion to which the device is couplable. The delivery tool comprises an applicator 150, containing an adhesive (160), that comprises a nozzle (153) that provides fluid communication between the applicator and the skirt. The delivery tool is configured to secure the device to a native valve (10) of the heart by: transluminally advancing the device to the heart, pressing the skirt against tissue of the native valve, and adhering the skirt to the tissue by, via the nozzle, dispensing the adhesive between the skirt and the tissue.

Description

Attorney Docket No: TMTTMT- 24122WO01CARDIAC IMPLANTSCROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims priority from Provisional U.S. Patent Application No.63 / 779,134 to Shafigh et al., filed March 27, 2025, entitled "Cardiac Implants."

[0002] This application is incorporated herein by reference in its entirety for all purposes.BACKGROUND

[0003] Ischemic heart disease causes mitral regurgitation by the combination of ischemic dysfunction of the papillary muscles, and the dilatation of the left ventricle that is present in ischemic heart disease, with the subsequent displacement of the papillary muscles and the dilatation of the mitral valve annulus.

[0004] Dilation of the annulus of the mitral valve prevents the valve leaflets from fully coapting when the valve is closed. Mitral regurgitation of blood from the left ventricle into the left atrium results in increased total stroke volume and decreased cardiac output, and ultimate weakening of the left ventricle secondary to a volume overload and a pressure overload of the left atrium. Tricuspid regurgitation can be similar.SUMMARY OF THE INVENTION

[0005] This summary is meant to provide some examples and is not intended to be limiting of the scope of the invention in any way. For example, any feature included in an example of this summary is not required by the claims, unless the claims explicitly recite the features. Also, the features, components, steps, concepts, etc. described in examples in this summary and elsewhere in this disclosure can be combined in a variety of ways. Various features and steps as described elsewhere in this disclosure may be included in the examples summarized here.

[0006] In some implementations, an implant comprises a docking station and a prosthetic valve that is seated within a dock of the docking station. In some implementations, a skirt at a downstream portion of the docking station restricts flow of blood to the dock, e.g., to the prosthetic valve when the prosthetic valve is seated within the dock.

[0007] In some implementations, a delivery tool is used to deliver the docking station to an atrium of a heart of a subject, such that the skirt is pressed against tissue of the atrium. In some implementations, the docking station is secured within the atrium, upstream of the native valve,Attorney Docket No: TMTTMT- 24122WO01in order to allow the native valve to continue to function, e.g., by allowing the native leaflets to at least partially coapt.

[0008] In some implementations, the delivery tool (e.g., an applicator thereof) is used to adhere the docking station to the atrium by dispensing adhesive between the skirt and the tissue. In some implementations, the adhesive is dispensed into a receptacle between the skirt and the tissue. In some implementations, the receptacle can be defined by cushions (e.g., an upstream cushion and / or a downstream cushion) and / or a permeable material disposed over the skirt. In some implementations, the adhesive strengthens the docking station, thereby allowing use of less material in the docking station than would be required in absence of the adhesive.

[0009] In some implementations, the docking station comprises a self-expanding frame. In some implementations, the delivery tool comprises a restraining element that restrains the docking station (e.g., an upstream portion thereof) from fully radially expanding. In some implementations, use of the restraining element may facilitate positioning of the docking station within the atrium. In some implementations, this can be done prior to fully expanding the docking station.

[0010] In some implementations, the connection between the delivery tool and the docking station comprises a flexible material, such as a cord, suture, tether, wire, etc. In some implementations, the flexible material may facilitate articulation of the docking station with respect to the delivery tool. In some implementations, the flexible material may allow for the frame to include less material than would be required in absence of the flexible material.

[0011] In some implementations, systems herein can comprise a docking station (e.g., which can be the same as or similar to any of the docking stations described anywhere in this disclosure) configured to receive a prosthetic valve therewithin. In some implementations, the systems can include a delivery tool (e.g., which can be the same as or similar to any of the delivery tools described anywhere in this disclosure).

[0012] In some implementations, the systems and / or delivery tool can comprise an applicator that contains an adhesive.

[0013] In some implementations, the delivery tool is configured to secure the docking station at or near an upstream side of a native heart valve. In some implementations, this can be done by the delivery tool transluminally advancing the docking station to the native heart valve such that the docking station is in contact with tissue at or near an inlet of the native heart valve such that the downstream portion of the docking station can open toward the inlet of the native heartAttorney Docket No: TMTTMT- 24122WO01valve. In some implementations, the delivery tool can be used to adhere the docking station to the tissue by dispensing the adhesive from the applicator, such that the adhesive contacts both the docking station and the tissue.

[0014] In some implementations, the docking station comprises a skirt at a downstream portion of the docking station. In some implementations, the applicator is configured to dispense the adhesive at a radial portion of the skirt, between the skirt and the tissue.

[0015] In some implementations, the delivery tool is configured to withdraw the applicator from the docking station, leaving the docking station secured in the atrium.

[0016] In some implementations, the docking station comprises a frame that defines a plurality of eyelets around a perimeter of the dock. In some implementations, the system comprises a flexible material (e.g., cord, suture, thread, braid, tether, line, wire, etc.), threaded through at least some eyelets of the plurality of eyelets. In some implementations, the flexible material is threaded through consecutive eyelets of the plurality of eyelets. In some implementations, the flexible material is not threaded through consecutive eyelets. In some implementations, the flexible material is threaded through eyelets in an arc around a portion of the docking station.

[0017] In some implementations, the delivery tool comprises a catheter. In some implementations, the delivery tool is configured to deploy the docking station from the catheter and into the atrium using the flexible material.

[0018] In some implementations, the frame is a self-expanding frame. In some implementations, the delivery tool is configured to control expansion of the frame by controlling tension on the flexible material.

[0019] In some implementations, the delivery tool is reversibly coupled to the docking station via the flexible material. In some implementations, the delivery tool is configured to disengage from the flexible material and to withdraw from the subject, leaving the flexible material and the docking station within the subject.

[0020] In some implementations, the delivery tool is reversibly coupled to the docking station via the flexible material. In some implementations, the delivery tool is configured to release the docking station by unthreading the flexible material from the eyelets, and withdraw from the subject, leaving the docking station within the subject.

[0021] In some implementations, the delivery tool is configured to facilitate expansion of the frame by reducing tension on the flexible material.Attorney Docket No: TMTTMT- 24122WO01

[0022] In some implementations, the flexible material is a first cord, threaded through at least some eyelets of the plurality, such that reducing tension on the first cord facilitates expansion of a first sector of the perimeter.

[0023] In some implementations, the system further comprises a second cord, threaded through at least some eyelets of the plurality, such that reducing tension on the second cord facilitates expansion of a second sector of the perimeter.

[0024] In some implementations, the delivery tool is operatively coupled to the first and second cords such that, by reducing tension on each of the cords independently of each other, each of the sectors is controllably expandable independently of the other sector.

[0025] In some implementations, the delivery tool is configured to release the docking station within the heart by unthreading each cord from respective eyelets.

[0026] In some implementations, the docking station is configured to define an adhesive receptacle.

[0027] In some implementations, the docking station comprises a pair of cushions comprising an upstream cushion and a downstream cushion, each cushion disposed on the docking station such that the pair of cushions define at least a portion of the adhesive receptacle.

[0028] In some implementations, the system further comprises the prosthetic valve. In some implementations, the prosthetic valve is configured to be transluminally advanceable, via the delivery tool, to or near the native heart valve. In some implementations, the prosthetic valve is configured to be seated within the docking station such that the prosthetic valve facilitates monodirectional flow of blood through the native heart valve.

[0029] In some implementations, the prosthetic valve comprises a plurality of prosthetic leaflets, configured to facilitate monodirectional flow of blood through the native valve, while remaining upstream of the native heart valve as the native heart valve reciprocatingly transitions between ventricular systole and ventricular diastole.

[0030] In some implementations, the system comprises a curing sleeve. In some implementations, the curing sleeve is transluminally advanceable via the delivery tool. In some implementations, the curing sleeve is configured to, after the adhesive is dispensed in contact with the docking station and the tissue, cure the adhesive.Attomey Docket No: TMTTMT- 24122WO01

[0031] In some implementations, the curing sleeve is configured to cure the adhesive by providing a curing reagent to the adhesive. In some implementations, the curing sleeve is configured to cure the adhesive by providing a curing energy to the adhesive.

[0032] In some implementations, the docking station comprises a skirt configured to inhibit flow of blood through the downstream portion of the docking station.

[0033] In some implementations, the docking station defines a central lumen, and the skirt is configured to inhibit flow of blood through the docking station, radially outside of the central lumen.

[0034] In some implementations, the docking station further comprises a permeable material that defines at least part of a pocket. In some implementations, the delivery tool is configured to dispense the adhesive in contact with the docking station and the tissue by dispensing the adhesive into the pocket such that some of the adhesive permeates the material and contacts the tissue.

[0035] In some implementations, the pocket circumscribes the skirt.

[0036] In some implementations, the pocket is shaped to define a ring-shaped sleeve disposed on a radial portion of the docking station.

[0037] In some implementations, the delivery tool comprises a catheter, transluminally advanceable to the atrium. In some implementations, the docking station comprises a shapememory frame, such that the docking station has a compressed state in which the docking station is transluminally advanceable, via the catheter, to the atrium. In some implementations, the docking station has an expanded state in which an external diameter of the docking station is greater than an internal diameter of an atrium upstream of the native heart valve, such that a radial portion of the skirt presses against tissue of the atrium at or near the native heart valve.

[0038] In some implementations, while the docking station is in the compressed state, the shape-memory frame has a tubular shape extending along a longitudinal axis. In some implementations, while the docking station is in the expanded state, a first portion of the frame extends along the longitudinal axis, and a second portion of the frame extends radially away from the longitudinal axis.

[0039] In some implementations, while the docking station is in the compressed state, the shape-memory frame has a tubular shape defining a medially-facing tube-interior and a radially-Attorney Docket No: TMTTMT- 24122WO01facing tube-exterior. In some implementations, while the docking station is in the expanded state, a portion of the tube-interior defines a radially -facing portion of the frame.

[0040] In some implementations, while the docking station is in the compressed state, the shape-memory frame has a tubular shape extending, along a longitudinal axis, from a proximal end to a distal end. In some implementations, while the docking station is in the expanded state, a portion of the frame defines a toroidal space, circumscribing the longitudinal axis of the frame.

[0041] In some implementations, the system comprises a plurality of restraining elements. In some implementations, each restraining element inhibits expansion of an upstream portion of the docking station.

[0042] In some implementations, the delivery tool is configured to transluminally advance the docking station to the atrium. In some implementations, the delivery tool is configured such that, while the restraining elements inhibit expansion of the upstream portion of the docking station, it can position the docking station such that the downstream portion of the docking station is open toward the inlet of the native valve. In some implementations, the delivery tool is configured to adjust each of the restraining elements such that the docking station further expands radially, thereby pressing the skirt against the tissue. In some implementations, the delivery tool is configured to secure the docking station to the tissue by subsequently, securing the docking station in the atrium by adhering the docking station to the tissue.

[0043] In some implementations, the delivery tool is configured to secure the docking station in the atrium by adhering the docking station to the tissue by dispensing the adhesive in contact with the docking station and the tissue, prior to releasing the restraining elements from the docking station.

[0044] In some implementations, the delivery tool is configured to secure the docking station in the atrium by adhering the docking station to the tissue by dispensing the adhesive in contact with the docking station and the tissue, after releasing the restraining elements from the docking station.

[0045] In some implementations, the delivery tool comprises the restraining elements, and is configured to be withdrawn from the subject, leaving the docking station secured in the atrium.

[0046] In accordance with some implementations, a system for use or usable with a prosthetic valve at a heart of a subject includes an expandable docking station. The heart can have a native valve disposed between an atrium of the heart and a ventricle of the heart. In someAttorney Docket No: TMTTMT- 24122WO01implementations, the docking station defines a dock (e.g., a tubular dock, etc.) that is configured to receive a prosthetic valve therewithin.

[0047] In some implementations, the docking station includes a skirt circumscribing a downstream portion of the dock.

[0048] In some implementations, the system further includes a delivery tool. In some implementations, the delivery tool includes an applicator that contains an adhesive. In some implementations, the delivery tool includes a nozzle that provides fluid communication between the applicator and the skirt.

[0049] In some implementations, the delivery tool is configured to secure the docking station in the atrium. In some implementations, the delivery tool is configured to secure the docking station in the atrium by transluminally advancing the docking station to the atrium, pressing the skirt against tissue of the atrium around an inlet of the native valve such that the downstream portion of the dock is open toward the inlet of the native valve, and / or adhering the docking station and / or skirt to the tissue. In some implementations, this is done by (e.g., via the nozzle, via a connector, via a pathway, etc.) dispensing the adhesive between the docking station and / or skirt and the tissue.

[0050] In some implementations, the docking station, the prosthetic valve and / or the delivery tool are sterile.

[0051] In some implementations, the applicator is configured to dispense the adhesive (e.g., via the nozzle, via a connector, via a pathway, etc.) on a radial portion of the skirt, between the skirt and the tissue.

[0052] In some implementations, the delivery tool is configured to withdraw the applicator from the docking station, leaving the docking station secured in the atrium.

[0053] In some implementations, the docking station includes a frame that defines a plurality of eyelets distributed circumferentially around a perimeter of the dock, In some implementations, the system includes a flexible material, such as a cord, suture, etc., threaded through consecutive eyelets of the plurality in an arc around the perimeter.

[0054] In some implementations, the delivery tool includes a catheter. In some implementations, the delivery tool is configured to deploy the docking station from the catheter and into the atrium, via the cord.Attorney Docket No: TMTTMT- 24122WO01

[0055] In some implementations: the frame is a self-expanding frame. In some implementations, the delivery tool is configured to control expansion of the frame by controlling tension on the cord.

[0056] In some implementations, the delivery tool is reversibly coupled to the docking station via the cord. In some implementations, the delivery tool is configured to disengage from the cord and to withdraw from the subject, leaving the cord and the docking station within the subject.

[0057] In some implementations, the delivery tool is reversibly coupled to the docking station via the cord. In some implementations, the delivery tool is configured to: release the docking station by unthreading the cord from the eyelets. In some implementations, the delivery tool is configured to be withdrawn from the subject, leaving the docking station within the subject.

[0058] In some implementations, the delivery tool is configured to facilitate expansion of the frame by reducing tension on the cord.

[0059] In some implementations, the flexible material or cord is a first cord (or other flexible material). In some implementations, the first cord, etc. is threaded through consecutive eyelets of the plurality in a first arc around the perimeter. In some implementations, it is arranged such that reducing tension on the first cord facilitates expansion of a first sector of the perimeter. In some implementations, the system further includes a second flexible material or second cord, threaded through consecutive eyelets of the plurality in a second arc around the perimeter. In some implementations, it is arranged such that reducing tension on the second cord (or other flexible material) facilitates expansion of a second sector of the perimeter.

[0060] In some implementations, the delivery tool is operatively coupled to the first and second cords such that, by reducing tension on each of the cords independently of each other, each of the sectors is controllably expandable independently of the other sectors.

[0061] In some implementations, the delivery tool is configured to: release the docking station within the heart by unthreading each cord from the respective consecutive eyelets. In some implementations, the delivery tool is configured to be withdrawn from the heart.

[0062] In some implementations, the skirt is configured to isolate the adhesive between the skirt and the tissue.

[0063] In some implementations, the docking station is configured to define an adhesive receptacle between the skirt and the tissue.Attorney Docket No: TMTTMT- 24122WO01

[0064] In some implementations, the nozzle provides fluid communication between the applicator and the adhesive receptacle.

[0065] In some implementations, the adhesive receptacle circumscribes the docking station.

[0066] In some implementations, the docking station includes a pair of cushions including an upstream cushion and a downstream cushion. In some implementations, each cushion is disposed on the skirt such that the pair of cushions and the skirt define the adhesive receptacle.

[0067] In some implementations, the system further includes the prosthetic valve. In some implementations, the prosthetic valve is configured to be: transluminally advanceable, via the delivery tool, to the atrium. In some implementations, the prosthetic valve is configured to be seated within the dock such that the prosthetic valve facilitates monodirectional flow of blood through the native valve.

[0068] In some implementations, the prosthetic valve includes a plurality of prosthetic leaflets, configured to facilitate monodirectional flow of blood through the native valve, while remaining within the atrium as the native valve reciprocatingly transitions between ventricular systole and ventricular diastole.

[0069] In some implementations, the system further includes a curing sleeve: transluminally advanceable via the delivery tool. In some implementations, the curing sleeve configured to, after the adhesive is dispensed between the skirt and the tissue, cure the adhesive.

[0070] In some implementations, the curing sleeve is configured to cure the adhesive by providing a curing reagent to the adhesive.

[0071] In some implementations, the curing sleeve is configured to cure the adhesive by providing a curing energy to the adhesive.

[0072] In some implementations, the skirt is configured to inhibit flow of blood through the downstream portion of the docking station.

[0073] In some implementations, the dock (e.g., tubular dock, etc.) defines a central lumen, and the skirt is configured to inhibit flow of blood through the docking station, radially of the central lumen.

[0074] In some implementations, the docking station further includes a permeable material disposed over the skirt to define a pocket between the skirt and the material. In some implementations, the nozzle opens into the pocket. In some implementations, the delivery tool is configured to dispense the adhesive (e.g., via the nozzle, via a connector, via a pathway, etc.)Attorney Docket No: TMTTMT- 24122WO01between the skirt and the tissue by dispensing the adhesive into the pocket such that some of the adhesive permeates the material and contacts the tissue.

[0075] In some implementations, the material has a greater porosity than the skirt.

[0076] In some implementations, the material is more hydrophilic than the skirt.

[0077] In some implementations, the pocket circumscribes the skirt.

[0078] In some implementations, the pocket is shaped to define a ring-shaped sleeve disposed on a radial portion of the skirt.

[0079] In some implementations, the delivery tool includes a catheter, transluminally advanceable to the atrium. In some implementations, the docking station includes a shapememory frame. In some implementations, the docking station has a compressed state in which the docking station is transluminally advanceable, via the catheter, to the atrium. In some implementations, the docking station has an expanded state in which an external diameter of the docking station is greater than an internal diameter of the atrium, such that a radial portion of the skirt presses against tissue of the atrium.

[0080] In some implementations, while the docking station is in the compressed state, the shape-memory frame has a tubular shape extending along a longitudinal axis. In some implementations, while the docking station is in the expanded state, a first portion of the frame extends along the longitudinal axis, and a second portion of the frame extends radially away from the longitudinal axis.

[0081] In some implementations, while the docking station is in the compressed state, the shape-memory frame has a tubular shape defining a medially -facing tube-interior and a radially-facing tube-exterior. In some implementations, while the docking station is in the expanded state, a portion of the tube-interior defines a radially-facing portion of the frame.

[0082] In some implementations, while the docking station is in the compressed state, the shape-memory frame has a tubular shape extending, along a longitudinal axis, from a proximal end to a distal end. In some implementations, while the docking station is in the expanded state, the distal end of the frame faces proximally.

[0083] In some implementations, while the docking station is in the compressed state, the shape-memory frame has a tubular shape extending, along a longitudinal axis, from a proximal end to a distal end. In some implementations, while the docking station is in the expanded state, a portion of the frame defines a toroidal space, circumscribing the longitudinal axis of the frame.Attorney Docket No: TMTTMT- 24122WO01

[0084] In some implementations, the system further includes a plurality of restraining elements, each restraining element inhibiting expansion of an upstream portion of the dock. In some implementations, the delivery tool is configured to secure the docking station in the atrium by: transluminally advancing the docking station to the atrium.

[0085] In some implementations, while the restraining elements inhibit expansion of the upstream portion of the dock, the delivery tool is configured to position the docking station such that the downstream portion of the dock is open toward the inlet of the native valve. In some implementations, the delivery tool is configured to adjust each of the restraining elements such that the docking station further expands radially, thereby pressing the skirt against tissue of the atrium. In some implementations, the delivery tool is configured to secure the docking station in the atrium by adhering the skirt to the tissue by (e.g., via the nozzle, via a connector, via a pathway, etc.) dispensing the adhesive between the skirt and the tissue.

[0086] In some implementations, the delivery tool is configured to secure the docking station in the atrium by adhering the skirt to the tissue by (e.g., via the nozzle, via a connector, via a pathway, etc.) dispensing the adhesive between the skirt and the tissue, prior to releasing the restraining elements from the docking station.

[0087] In some implementations, the delivery tool is configured to secure the docking station in the atrium by adhering the skirt to the tissue by (e.g., via the nozzle, via a connector, via a pathway, etc.) dispensing the adhesive between the skirt and the tissue, subsequently to releasing the restraining elements from the docking station.

[0088] In some implementations, the restraining elements are nonmetallic.

[0089] In some implementations, the restraining elements are more flexible than the dock.

[0090] In some implementations, the delivery tool includes the restraining elements. In some implementations, the delivery tool is configured to be withdrawn from the subject, leaving the docking station secured in the atrium.

[0091] In some implementations, the delivery tool is configured to release the restraining elements from the docking station. In some implementations, the delivery tool is configured to seat the prosthetic valve within the tubular dock such that the prosthetic valve facilitates monodirectional flow of blood through the native valve.Attorney Docket No: TMTTMT- 24122WO01

[0092] In some implementations, the docking station includes the restraining elements. In some implementations, the delivery tool is configured to be withdrawn from the subject, leaving the docking station secured in the atrium.

[0093] In some implementations, the restraining elements are reversibly coupled to a nonmetallic portion of the docking station.

[0094] In accordance with some implementations, a system (e.g., usable and / or for use with a subject, such as a living subject and / or simulation) includes an implant including a selfexpanding frame that defines a lumen of the implant. In some implementations, the frame has a plurality of eyelets distributed circumferentially around a perimeter of an end of the lumen. In some implementations, the implant has a compressed state in which the implant is advanceable into the subject. In some implementations, the implant has an expanded state in which the implant is configured to function within the subject, and in which the lumen is wider than in the compressed state.

[0095] In some implementations, the system includes a flexible material or cord, threaded through consecutive eyelets of the plurality in an arc around the perimeter. In some implementations, the flexible material or cord can be configured as a suture, wire, line, tether, thread, braid, etc.

[0096] In some implementations, the system includes a delivery tool, configured to: advance, into the subject, the implant in its compressed state. In some implementations, the delivery tool is configured to, within the subject, control expansion of the implant toward the expanded state by controlling tension on the flexible material or cord.

[0097] In some implementations, the delivery tool is reversibly coupled to the implant via the cord. In some implementations, the delivery tool is configured to disengage from the cord and to withdraw from the subject, leaving the cord and the implant within the subject.

[0098] In some implementations, the delivery tool is reversibly coupled to the implant via the cord. In some implementations, the delivery tool is configured to release the implant by unthreading the cord from the eyelets. In some implementations, the delivery tool is configured to be withdrawn from the subject, leaving the implant within the subject.

[0099] In some implementations, the delivery tool is configured to facilitate expansion of the implant toward the expanded state by reducing tension on the cord.

[0100] In some implementations, the implant, delivery tool and / or the cord are sterile.Attorney Docket No: TMTTMT- 24122WO01

[0101] In some implementations, the flexible material or cord is a first cord, threaded through consecutive eyelets of the plurality in a first arc around the perimeter, such that reducing tension on the first cord facilitates expansion of a first sector of the perimeter. In some implementations, the system further includes a second flexible material or second cord, threaded through consecutive eyelets of the plurality in a second arc around the perimeter. In some implementations, it is configured such that reducing tension on the second cord facilitates expansion of a second sector of the perimeter.

[0102] In some implementations, the delivery tool includes an applicator that contains an adhesive, In some implementations, the delivery tool is configured to secure the implant to tissue of the subject by adhering the implant to the tissue.

[0103] In some implementations, the delivery tool is configured to withdraw the applicator from the implant, leaving the implant secured to the tissue.

[0104] In some implementations, the implant includes a skirt circumscribing the implant. In some implementations, the applicator includes a nozzle that provides fluid communication between the applicator and the skirt. In some implementations, the delivery tool is configured to secure the implant to the tissue by adhering the skirt to the tissue by (e.g., via the nozzle, via a connector, via a pathway, etc.) dispensing the adhesive between the skirt and the tissue.

[0105] In some implementations, the applicator is configured to dispense the adhesive (e.g., via the nozzle, via a connector, via a pathway, etc.) on a radial portion of the skirt, between the skirt and the tissue.

[0106] In some implementations, the skirt is configured to isolate the adhesive between the skirt and the tissue.

[0107] In some implementations, the implant is configured to define an adhesive receptacle between the skirt and the tissue.

[0108] In some implementations, the nozzle provides fluid communication between the applicator and the adhesive receptacle.

[0109] In some implementations, the adhesive receptacle circumscribes the implant.

[0110] In some implementations, the implant includes a pair of cushions. In some implementations, each cushion is disposed on the skirt such that the pair of cushions and the skirt define the adhesive receptacle.Attorney Docket No: TMTTMT- 24122WO01

[0111] In some implementations, the system further includes a curing sleeve transluminally advanceable via the delivery tool. In some implementations, the curing sleeve is configured to, after the adhesive is dispensed between the skirt and the tissue, cure the adhesive.

[0112] In some implementations, the curing sleeve is configured to cure the adhesive by providing a curing reagent to the adhesive.

[0113] In some implementations, the curing sleeve is configured to cure the adhesive by providing a curing energy to the adhesive.

[0114] In some implementations, the implant further includes a permeable material disposed over the skirt to define a pocket between the skirt and the material. In some implementations, the nozzle opens into the pocket. In some implementations, the delivery tool is configured to dispense the adhesive (e.g., via the nozzle, via another connector, via a pathway, etc.), between the skirt and the tissue by dispensing the adhesive into the pocket such that some of the adhesive permeates the material and contacts the tissue.

[0115] In some implementations, the material has a greater porosity than the skirt.

[0116] In some implementations, the material is more hydrophilic than the skirt.

[0117] In some implementations, the pocket circumscribes the skirt.

[0118] In some implementations, the pocket is shaped to define a ring-shaped sleeve disposed on a radial portion of the skirt.

[0119] In accordance with some implementations, a system (e.g., usable and / or for use at a heart of a subject, such as a living subject or simulation) includes an implant including a selfexpanding frame that defines a lumen of the implant. In some implementations, the frame has a plurality of eyelets distributed circumferentially around a perimeter of an end of the lumen. In some implementations, the implant has a compressed state in which the implant is transluminally advanceable to the heart. In some implementations, the implant has an expanded state in which the implant is configured for blood flow through the lumen, and in which the lumen is wider than in the compressed state.

[0120] In some implementations, the system includes a delivery tool including a catheter. In some implementations, the delivery tool includes an extracorporeal controller at a proximal end of the catheter. In some implementations, the delivery tool includes at least three cords or other flexible material.Attorney Docket No: TMTTMT- 24122WO01

[0121] In some implementations, each cord (or other flexible material) extends, from the controller, through the catheter to the implant. In some implementations, each cord or other material is threaded through consecutive eyelets of the plurality in an arc around the perimeter. In some implementations, each arc defines a corresponding sector of the end of the lumen.

[0122] In some implementations, the delivery tool is configured to transluminally advance, to the heart, the implant in its compressed state within the catheter. In some implementations, the delivery tool is operatively coupled to the cords such that, via control of tension on each of the cords independently of each other, each of the sectors is controllably expandable independently of the other sectors.

[0123] In some implementations, the implant includes a self-expanding docking station. In some implementations, the docking station is configured to, while in the expanded state, to press circumferentially against a wall of an atrium of the heart. In some implementations, the docking station comprises a dock (e.g., a tubular dock, etc.), defining the lumen, that is configured to receive a prosthetic valve therewithin.

[0124] In some implementations, the delivery tool is configured to release the implant within the heart by unthreading each cord from the respective consecutive eyelets. In some implementations, the delivery tool is configured to be withdrawn from the heart.

[0125] In some implementations, the implant includes a self-expandable prosthetic valve.

[0126] In some implementations, the prosthetic valve includes prosthetic leaflets. In some implementations, the prosthetic valve is configured to be implanted within an atrium of the heart such that the prosthetic leaflets are disposed within the atrium, upstream of a native valve of the heart.

[0127] In some implementations, the implant, delivery tool and / or the cords are sterile.

[0128] In some implementations, the delivery tool includes an applicator that contains an adhesive. In some implementations, the delivery tool is configured to secure the implant to tissue of the heart by adhering the implant to the tissue.

[0129] In some implementations, the delivery tool is configured to withdraw the applicator from the implant, leaving the implant secured to the tissue.

[0130] In some implementations, the implant includes a skirt circumscribing the implant. In some implementations, the applicator includes a nozzle (or other connector or pathway, etc.) that provides fluid communication between the applicator and the skirt. In someAttorney Docket No: TMTTMT- 24122WO01implementations, the delivery tool is configured to secure the implant to the tissue by adhering the skirt to the tissue by (e.g., via the nozzle, via a connector, via a pathway, etc.) dispensing the adhesive between the skirt and the tissue.

[0131] In some implementations, the applicator is configured to dispense the adhesive (e.g., via the nozzle, via a connector, via a pathway, etc.) on a radial portion of the skirt, between the skirt and the tissue.

[0132] In some implementations, the skirt is configured to isolate the adhesive between the skirt and the tissue.

[0133] In some implementations, the implant is configured to define an adhesive receptacle between the skirt and the tissue.

[0134] In some implementations, the nozzle provides fluid communication between the applicator and the adhesive receptacle.

[0135] In some implementations, the adhesive receptacle circumscribes the implant.

[0136] In some implementations, the implant includes a pair of cushions. In some implementations, each cushion disposed on the skirt such that the pair of cushions and the skirt define the adhesive receptacle.

[0137] In some implementations, the system further includes a curing sleeve. In some implementations, the curing sleeve is transluminally advanceable via the delivery tool. In some implementations, the curing sleeve is configured to, after the adhesive is dispensed between the skirt and the tissue, cure the adhesive.

[0138] In some implementations, the curing sleeve is configured to cure the adhesive by providing a curing reagent to the adhesive.

[0139] In some implementations, the curing sleeve is configured to cure the adhesive by providing a curing energy to the adhesive.

[0140] In some implementations, the implant further includes a permeable material disposed over the skirt to define a pocket between the skirt and the material. In some implementations, the nozzle opens into the pocket. In some implementations, the delivery tool is configured to dispense the adhesive (e.g., via the nozzle, via a connector, via a pathway, etc.) between the skirt and the tissue by dispensing the adhesive into the pocket such that some of the adhesive permeates the material and contacts the tissue.Attorney Docket No: TMTTMT- 24122WO01

[0141] In some implementations, the material has a greater porosity than the skirt.

[0142] In some implementations, the material is more hydrophilic than the skirt.

[0143] In some implementations, the pocket circumscribes the skirt.

[0144] In some implementations, the pocket is shaped to define a ring-shaped sleeve disposed on a radial portion of the skirt.

[0145] In accordance with some implementations, a system (e.g., usable and / or for use at a heart of a subject, the heart having an atrium) includes an implant including a self-expanding frame that defines a lumen of the implant. In some implementations, the implant has a compressed state in which the implant is transluminally advanceable to the atrium. In some implementations, the implant has an expanded state in which the implant is configured to press circumferentially against a wall of the atrium.

[0146] In some implementations, the system includes a cord or other flexible material, coupled to at least three points along a perimeter of an end of the lumen.

[0147] In some implementations, the system includes a delivery tool, reversibly coupled to the implant via the cord or flexible material. In some implementations, the delivery tool defines a distal portion reversibly coupled to the cord or flexible material. In some implementations, the delivery tool is configured to transluminally advance, into the atrium, the implant in its compressed state. In some implementations, the delivery tool is configured to, within the atrium, control expansion of the implant toward the expanded state by controlling tension on the cord or flexible material.

[0148] In some implementations, the delivery tool is configured to reduce tension on the cord or flexible material, thereby allowing the implant to radially expand against a wall of the atrium, secure the implant to the wall of the atrium.

[0149] In some implementations, the delivery tool includes an applicator that contains an adhesive. In some implementations, the delivery tool is configured to secure the implant to tissue of the heart by adhering the implant to the tissue.

[0150] In some implementations, the delivery tool is configured to withdraw the applicator from the implant, leaving the implant secured to the tissue.

[0151] In some implementations, the implant, the delivery tool and / or the cord are sterile.Attorney Docket No: TMTTMT- 24122WO01

[0152] In some implementations, the implant includes a skirt circumscribing the implant. In some implementations, the applicator includes a nozzle (or other connector or pathway) that provides fluid communication between the applicator and the skirt. In some implementations, the delivery tool is configured to secure the implant to the tissue by adhering the skirt to the tissue by (e.g., via the nozzle, via a connector, via a pathway, etc.) dispensing the adhesive between the skirt and the tissue.

[0153] In some implementations, the applicator is configured to dispense the adhesive (e.g., via the nozzle, via a connector, via a pathway, etc.) on a radial portion of the skirt, between the skirt and the tissue.

[0154] In some implementations, the skirt is configured to isolate the adhesive between the skirt and the tissue.

[0155] In some implementations, the implant is configured to define an adhesive receptacle between the skirt and the tissue.

[0156] In some implementations, the nozzle provides fluid communication between the applicator and the adhesive receptacle.

[0157] In some implementations, the adhesive receptacle circumscribes the implant.

[0158] In some implementations, the implant includes a pair of cushions, each cushion disposed on the skirt such that the pair of cushions and the skirt define the adhesive receptacle.

[0159] In some implementations, the system further includes a curing sleeve. In some implementations, the curing sleeve is transluminally advanceable via the delivery tool. In some implementations, the curing sleeve is configured to, after the adhesive is dispensed between the skirt and the tissue, cure the adhesive.

[0160] In some implementations, the curing sleeve is configured to cure the adhesive by providing a curing reagent to the adhesive.

[0161] In some implementations, the curing sleeve is configured to cure the adhesive by providing a curing energy to the adhesive.

[0162] In some implementations, the implant further includes a permeable material disposed over the skirt to define a pocket between the skirt and the material. In some implementations, the nozzle opens into the pocket. In some implementations, the delivery tool is configured to dispense the adhesive (e.g., via the nozzle, via a connector, via a pathway, etc.) between theAttorney Docket No: TMTTMT- 24122WO01skirt and the tissue by dispensing the adhesive into the pocket such that some of the adhesive permeates the material and contacts the tissue.

[0163] In some implementations, the material has a greater porosity than the skirt.

[0164] In some implementations, the material is more hydrophilic than the skirt.

[0165] In some implementations, the pocket circumscribes the skirt.

[0166] In some implementations, the pocket is shaped to define a ring-shaped sleeve disposed on a radial portion of the skirt.

[0167] In accordance with some implementations, a system useable and / or for use with a prosthetic valve (e.g., at a heart of a subject, the heart having a native valve disposed between an atrium of the heart and a ventricle of the heart) includes a self-expanding docking station. In some implementations, the docking station has a compressed state in which the docking station is transluminally advanceable to the atrium. In some implementations, the docking station has an expanded state in which the docking station is configured to press circumferentially against a wall of the atrium.

[0168] In some implementations, the docking station comprises a tubular dock that is configured to receive a prosthetic valve therewithin.

[0169] In some implementations, the system comprises a cord or other flexible material, coupled to at least three points along a perimeter of an upstream portion of the dock.

[0170] In some implementations, the system includes a delivery tool. In some implementations, the delivery tool is configured to transluminally advance the docking station to the atrium. In some implementations, the delivery tool is configured to deploy the docking station, via the cord, from the tool into the atrium, such that the docking station presses circumferentially against the wall of the atrium around an inlet of the native valve such that a downstream portion of the dock is open toward the inlet of the native valve. In some implementations, the delivery tool is configured to secure the docking station to the wall of the atrium.

[0171] In some implementations, the delivery tool, the docking station and / or the cord are sterile.

[0172] In some implementations, the delivery tool is reversibly coupled to the docking station, via the cord or flexible material. In some implementations, the delivery tool is configured to disengage from the cord or flexible material and to withdraw from the heart, leaving the cord and the docking station secured to the wall of the atrium.Attorney Docket No: TMTTMT- 24122WO01

[0173] In some implementations, the delivery tool is reversibly coupled to the docking station, via the cord. In some implementations, the delivery tool is configured to release the docking station by decoupling the cord from the docking station and to withdraw from the heart, leaving the docking station secured to the wall of the atrium.

[0174] In some implementations, the system further includes the prosthetic valve, configured to be seated within the tubular dock.

[0175] In some implementations, the delivery tool is configured to, after deploying the docking station into the atrium, adjust tension on the upstream portion of the dock, via the cord, such that the docking station expands circumferentially against the wall of the atrium.

[0176] In some implementations, the delivery tool is configured to, after deploying the docking station into the atrium, reduce tension on the cord such that the docking station expands circumferentially against the wall of the atrium.

[0177] In some implementations, the cord or flexible material is a first cord, coupled to a first portion of the perimeter of the upstream portion of the dock. In some implementations, it is configured such that reducing tension on the first cord facilitates expansion of the first portion of the perimeter of the upstream portion of the dock. In some implementations, the system further includes a second cord or second flexible material, coupled to a second portion of the perimeter of the upstream portion of the dock, such that reducing tension on the second cord or second flexible material facilitates expansion of the second portion of the perimeter of the upstream portion of the dock.

[0178] In some implementations, the delivery tool includes an applicator that contains an adhesive. In some implementations, the delivery tool is configured to secure the docking station to the wall of the atrium by adhering the docking station to the wall of the atrium.

[0179] In some implementations, the delivery tool is configured to withdraw the applicator from the docking station, leaving the docking station secured to the wall of the atrium.

[0180] In some implementations, the docking station includes a skirt circumscribing the docking station. In some implementations, the applicator includes a nozzle (or other connector or pathway) that provides fluid communication between the applicator and the skirt. In some implementations, the delivery tool is configured to secure the docking station to the wall of the atrium by adhering the skirt to the wall of the atrium by, via the nozzle (or other connector / pathway), dispensing the adhesive between the skirt and the wall of the atrium.Attorney Docket No: TMTTMT- 24122WO01

[0181] In some implementations, the applicator is configured to dispense the adhesive (e.g., via the nozzle, via a connector, via a pathway, etc.) on a radial portion of the skirt, between the skirt and the wall of the atrium.

[0182] In some implementations, the skirt is configured to isolate the adhesive between the skirt and the wall of the atrium.

[0183] In some implementations, the docking station is configured to define an adhesive receptacle between the skirt and the wall of the atrium.

[0184] In some implementations, the nozzle (or other connector / pathway) provides fluid communication between the applicator and the adhesive receptacle.

[0185] In some implementations, the adhesive receptacle circumscribes the docking station.

[0186] In some implementations, the docking station includes a pair of cushions. In some implementations, each cushion disposed on the skirt such that the pair of cushions and the skirt define the adhesive receptacle.

[0187] In some implementations, the system further includes a curing sleeve. In some implementations, the curing sleeve transluminally advanceable via the delivery tool. In some implementations, the curing sleeve is configured to, after the adhesive is dispensed between the skirt and the wall of the atrium, cure the adhesive.

[0188] In some implementations, the curing sleeve is configured to cure the adhesive by providing a curing reagent to the adhesive.

[0189] In some implementations, the curing sleeve is configured to cure the adhesive by providing a curing energy to the adhesive.

[0190] In some implementations, the docking station further includes a permeable material disposed over the skirt to define a pocket between the skirt and the material. In some implementations, the nozzle opens into the pocket. In some implementations, the delivery tool configured to dispense the adhesive (e.g., via the nozzle, via a connector, via a pathway, etc.) between the skirt and the wall of the atrium by dispensing the adhesive into the pocket such that some of the adhesive permeates the material and contacts the wall of the atrium.

[0191] In some implementations, the material has a greater porosity than the skirt.

[0192] In some implementations, the material is more hydrophilic than the skirt.

[0193] In some implementations, the pocket circumscribes the skirt.Attorney Docket No: TMTTMT- 24122WO01

[0194] In some implementations, the pocket is shaped to define a ring-shaped sleeve disposed on a radial portion of the skirt.

[0195] In accordance with some implementations, a system (e.g., usable and / or for use at a heart of a subject (e.g., living subject or simulation), the heart having a native valve disposed between an atrium of the heart and a ventricle of the heart) includes a device (e.g., a prosthetic valve, a treatment device, a repair device, a replacement device, etc.). In some implementations, the device includes a skirt circumscribing a downstream portion of the device. In some implementations, a delivery tool includes an applicator that contains an adhesive. In some implementations, the delivery tool includes a nozzle (or other connector or pathway) that provides fluid communication between the applicator and the skirt.

[0196] In some implementations, the delivery tool is configured to transluminally advance the device to the atrium and press the skirt against tissue of the atrium around an inlet of the native valve such that the downstream portion of the device is open toward the inlet of the native valve. In some implementations, the delivery tool is configured to secure the device in the atrium by adhering the skirt to the tissue by (e.g., via the nozzle, via a connector, via a pathway, etc.) dispensing the adhesive between the skirt and the tissue.

[0197] In some implementations, the device and the delivery tool are sterile.

[0198] In some implementations, the distal portion of the delivery tool defines an arm to which the device is rigidly mountable.

[0199] In some implementations, the applicator is configured to dispense the adhesive (e.g., via the nozzle, via a connector, via a pathway, etc.) on a radial portion of the skirt, between the skirt and the tissue.

[0200] In some implementations, the skirt is configured to isolate the adhesive between the skirt and the tissue.

[0201] In some implementations, the device is configured to define an adhesive receptacle between the skirt and the tissue.

[0202] In some implementations, the nozzle provides fluid communication between the applicator and the adhesive receptacle.

[0203] In some implementations, the adhesive receptacle circumscribes the device.Attorney Docket No: TMTTMT- 24122WO01

[0204] In some implementations, the device includes a pair of cushions. In some implementations, each cushion disposed on the skirt such that the pair of cushions and the skirt define the adhesive receptacle.

[0205] In some implementations, the system further includes a curing sleeve. In some implementations, the curing sleeve is transluminally advanceable via the delivery tool. In some implementations, the curing sleeve is configured to, after the adhesive is dispensed between the skirt and the tissue, cure the adhesive.

[0206] In some implementations, the curing sleeve is configured to cure the adhesive by providing a curing reagent to the adhesive.

[0207] In some implementations, the curing sleeve is configured to cure the adhesive by providing a curing energy to the adhesive.

[0208] In some implementations, the device further includes a permeable material disposed over the skirt to define a pocket between the skirt and the material. In some implementations, the nozzle (or other connector / pathway) opens into the pocket. In some implementations, the delivery tool is configured to dispense the adhesive (e.g., via the nozzle, via a connector, via a pathway, etc.) between the skirt and the tissue by dispensing the adhesive into the pocket such that some of the adhesive permeates the material and contacts the tissue.

[0209] In some implementations, the material has a greater porosity than the skirt.

[0210] In some implementations, the material is more hydrophilic than the skirt.

[0211] In some implementations, the pocket circumscribes the skirt.

[0212] In some implementations, the pocket is shaped to define a ring-shaped sleeve disposed on a radial portion of the skirt.

[0213] In accordance with some implementations, a method (e.g., useable and / or for use at a heart of a subject (e.g., a living subject or simulation), the heart having a native valve disposed between an atrium of the heart and a ventricle of the heart) including transluminally advancing, via a delivery tool, a compressed docking station to an atrium. In some implementations, the docking station defines a dock (e.g., a tubular dock, etc.) configured to receive a prosthetic valve therewithin. In some implementations, the docking station includes a skirt circumscribing a downstream portion of the dock.

[0214] In some implementations, the method includes deploying the docking station from the delivery tool such that the docking station expands radially into a position within the atrium. InAttorney Docket No: TMTTMT- 24122WO01some implementations, the method includes pressing the skirt against a wall of the atrium around an inlet of the native valve such that the downstream portion of the dock is open toward an inlet of the native valve. In some implementations, the method includes pressing the skirt against a wall of the atrium around an inlet of the native valve such that the dock is disposed upstream of the native valve.

[0215] In some implementations, the method includes transluminally advancing an applicator via the delivery tool such that a distal nozzle (or other connector or pathway) of the applicator provides fluid communication between the applicator and the skirt.

[0216] In some implementations, the method includes, while using the delivery tool to hold the docking station in the position, securing the docking station in the atrium by adhering the skirt to tissue of the atrium by (e.g., via the nozzle, via a connector, via a pathway, etc.) dispensing the adhesive between the skirt and the tissue.

[0217] In some implementations, the method includes seating a prosthetic valve within the dock. In some implementations, the prosthetic valve includes a plurality of prosthetic leaflets. In some implementations, the prosthetic valve is seated within the dock such that the prosthetic leaflets facilitate monodirectional flow of blood through the native valve.

[0218] In some implementations, the method further includes sterilizing the delivery tool, the docking station and the prosthetic valve.

[0219] In some implementations, the method further includes, subsequently to the step of securing, withdrawing the applicator from between the applicator and the skirt, thereby leaving the docking station secured in the atrium.

[0220] In some implementations, seating includes seating the prosthetic valve within the dock such that the prosthetic leaflets remain within the atrium as the native valve reciprocatingly transitions between ventricular systole and ventricular diastole.

[0221] In some implementations, seating includes 2-10 weeks subsequently to adhering the skirt to the tissue, seating the prosthetic valve within the dock such that the prosthetic leaflets facilitate monodirectional flow of blood through the native valve.

[0222] In some implementations, dispensing the adhesive between the skirt and the tissue includes dispensing the adhesive into a toroidal space between the skirt and the tissue.

[0223] In some implementations, dispensing the adhesive between the skirt and the tissue includes electrically insulating the docking station from the tissue.Attorney Docket No: TMTTMT- 24122WO01

[0224] In some implementations, the skirt includes a permeable material disposed over the skirt to define a pocket between the skirt and the material. In some implementations, the nozzle (or other connector / pathway) opens into the pocket. In some implementations, dispensing the adhesive includes dispensing the adhesive (e.g., via the nozzle, via a connector, via a pathway, etc.) into the pocket such that some of the adhesive permeates the material and contacts the tissue.

[0225] In some implementations, the docking station includes a pair of cushions including an upstream cushion and a downstream cushion. In some implementations, dispensing the adhesive between the skirt and the tissue includes dispensing the adhesive into a space circumscribed by the skirt, the pair of cushions, and the tissue.

[0226] In some implementations, the method further includes, subsequently to dispensing the adhesive between the skirt and the tissue curing the adhesive by transluminally advancing a curing agent, via the delivery tool, to between the skirt and the tissue.

[0227] In some implementations, seating the prosthetic valve includes, subsequently to curing the adhesive, seating the prosthetic valve within the dock such that the prosthetic leaflets facilitate monodirectional flow of blood through the native valve.

[0228] In some implementations, curing the adhesive includes transluminally advancing a curing reagent, via the delivery tool, to between the skirt and the tissue.

[0229] In some implementations, curing the adhesive includes transluminally advancing a curing energy, via the delivery tool, to between the skirt and the tissue.

[0230] In accordance with some implementations, a method (e.g., usable and / or for use at a heart of a subject (e.g., a living subject or simulation), the heart having a native valve disposed between an atrium of the heart and a ventricle of the heart) includes transluminally advancing, via a delivery tool, a compressed docking station to the atrium. In some implementations, the docking station defines a dock (e.g., a tubular dock, etc.) configured to receive a prosthetic valve therewithin. In some implementations, the docking station includes a skirt circumscribing a downstream portion of the dock.

[0231] In some implementations, the method further includes sterilizing the delivery tool, the docking station and the prosthetic valve.

[0232] In some implementations, the method includes deploying the docking station from the delivery tool, while restraining an upstream opening of the dock from fully radially expanding,Attorney Docket No: TMTTMT- 24122WO01into the atrium. In some implementations, this is done such that the dock is disposed upstream of the native valve, and / or a downstream opening of the dock faces an inlet of the native valve.

[0233] In some implementations, the method includes allowing the docking station to further radially expand, such that expansion of the docking station presses the skirt against a wall of the atrium. In some implementations, the method includes securing the skirt to the wall of the atrium.

[0234] In some implementations, the method further includes seating a prosthetic valve within the dock such that prosthetic leaflets of the prosthetic valve are disposed within the atrium, upstream of the native valve.

[0235] In some implementations, restraining includes restraining the upstream opening of the dock from fully radially expanding by, using the delivery tool, maintaining tension upon a restraining element coupled to the upstream opening of the dock. In some implementations, allowing the docking station to further radially expand includes decoupling (or reducing tension in) the restraining element from the dock. In some implementations, the restraining element comprises a cord or flexible material.

[0236] In some implementations, the method further includes, using the delivery tool, removing the restraining element from the subject.

[0237] In some implementations, the restraining element is coupled to the upstream opening of the dock via a cord or flexible material that is threaded through the upstream opening of the dock. In some implementations, decoupling the restraining element from the dock includes decoupling the restraining element from the cord or flexible material.

[0238] In some implementations, the restraining element is a first restraining element, coupled to a first portion of the upstream opening of the dock. In some implementations, maintaining tension includes maintaining tension upon the first restraining element coupled to the first portion of the upstream opening of the dock. In some implementations, a second restraining element is coupled to a second portion of the upstream opening of the dock. In some implementations, allowing the docking station to further radially expand includes decoupling (or reducing tension in) the first restraining element from the first portion of the upstream opening of the dock. In some implementations, allowing the docking station to further radially expand includes decoupling (or reducing tension in) the second restraining element from the second portion of the upstream opening of the dock.Attorney Docket No: TMTTMT- 24122WO01

[0239] In some implementations, the first and second restraining elements each include a first and second cord (or other flexible material), each cord threaded through eyelets of a respective portion of the upstream opening of the dock. In some implementations, decoupling includes unthreading each cord from the eyelets of the respective portion of the upstream opening of the dock.

[0240] In accordance with some implementations, a method (e.g., useable and / or for use at a heart of a subject) includes transluminally advancing, using a delivery tool, a compressed implant to the heart. In some implementations, the method includes deploying the implant from the delivery tool via a cord or other flexible material that is threaded through an upstream portion of the implant. In some implementations, the method includes deploying the implant while the cord restrains the upstream portion of the implant from fully radially expanding, into a position within the heart.

[0241] In some implementations, the method includes, while holding the implant in the position, adjusting tension on the cord to allow the implant to further radially expand, thereby pressing the implant against tissue of the heart. In some implementations, the method includes securing the implant to the heart. In some implementations, the method includes withdrawing the delivery tool from the heart.

[0242] In some implementations, the method further includes sterilizing the delivery tool, the delivery tool and the implant.

[0243] In some implementations, the method further includes, prior to the step of withdrawing, releasing the cord from the delivery tool, such that withdrawing the delivery tool from the heart includes leaving the cord and the implant within the heart.

[0244] In some implementations, adjusting tension includes reducing tension on the cord to allow the implant to further radially expand, thereby pressing the implant against tissue of the heart.

[0245] In some implementations, deploying includes deploying the implant from the delivery tool via a plurality of distal arms of the delivery tool that are coupled to the cord. In some implementations, reducing tension on the cord includes reducing tension on the cord by pivoting the distal arms radially apart.

[0246] In some implementations, the method further includes, prior to withdrawing the delivery tool from the heart, releasing the implant within the heart by unthreading the cord from the upstream portion of the implant.Attorney Docket No: TMTTMT- 24122WO01

[0247] In some implementations, the cord or flexible material is a first cord, threaded through the upstream portion of the implant along a first arc around a perimeter of the upstream portion. In some implementations, the system further includes a second cord or second flexible material, threaded through the upstream portion of the implant along a second arc around the perimeter of the upstream portion. In some implementations, adjusting tension includes adjusting tension on the first cord and the second cord.

[0248] In some implementations, adjusting tension includes adjusting tension of the first cord and the second cord, independently of each other.

[0249] In some implementations, the method further includes, prior to withdrawing the delivery tool from the heart, releasing the implant within the heart by unthreading each cord from the upstream portion of the implant.

[0250] In accordance with some implementations, a system useable and / or for use at a heart of a subject, the heart having a native valve includes a device (e.g., a prosthetic valve, a treatment device, a repair device, a replacement device, an expandable device, etc.). In some implementations, the device includes a skirt circumscribing at least a portion of the device.

[0251] In some implementations, the device can be configured as a prosthetic valve and the portion can be a valve portion.

[0252] In some implementations, the system includes a delivery tool. In some implementations, the delivery tool has a distal portion on which the device is mountable and / or connectable.

[0253] In some implementations, the delivery tool includes an applicator that contains an adhesive and includes a nozzle that provides fluid communication between the applicator and the skirt.

[0254] In some implementations, the delivery tool is configured to secure the device to the native valve by: transluminally advancing the device to the heart, pressing the skirt against tissue of the native valve, and / or adhering the skirt to the tissue. In some implementations, the skirt can be adhered to the tissue by, via the nozzle, dispensing the adhesive between the skirt and the tissue.

[0255] In some implementations, the device, delivery tool and applicator are sterile.

[0256] In some implementations, the delivery tool is configured to secure the device to the native valve by pressing the skirt against tissue at an inlet of the native valve such that a downstream portion of the device is open toward the inlet of the native valve.Attorney Docket No: TMTTMT- 24122WO01

[0257] In some implementations, the device is shaped to have an upstream circumferential bulge at an upstream portion of the skirt and a downstream circumferential bulge at a downstream portion of the skirt.

[0258] In some implementations, the portion is a valve portion that includes a stent and prosthetic leaflets mounted within the stent.

[0259] In some implementations, the applicator is configured to dispense the adhesive via the nozzle, on a radial portion of the skirt, between the skirt and the tissue.

[0260] In some implementations, the delivery tool is configured to withdraw the applicator from the device, leaving the device secured to the tissue.

[0261] In some implementations, the applicator is a first applicator. In some implementations, the delivery tool includes multiple applicators including the first applicator. In some implementations, the multiple applicators diverging from each other at the distal portion such that the nozzles of the applicators are distributed circumferentially around the skirt.

[0262] In some implementations, the delivery tool includes 2-12 applicators. In some implementations, the delivery tool includes 6-12 applicators.

[0263] In some implementations, the skirt circumscribes a downstream portion of the device.

[0264] In some implementations, the skirt is radially spaced from the portion.

[0265] In some implementations, the device includes a frame having a radial portion that supports the skirt radially spaced from the portion.

[0266] In some implementations, the skirt is configured to isolate the adhesive between the skirt and the tissue.

[0267] In some implementations, the device is configured to define an adhesive receptacle between the skirt and the tissue.

[0268] In some implementations, the adhesive receptacle circumscribes the device.

[0269] In some implementations, the nozzle provides fluid communication between the applicator and the adhesive receptacle.

[0270] In some implementations, the nozzle is disposed at the adhesive receptacle.Attorney Docket No: TMTTMT- 24122WO01

[0271] In some implementations, the device is shaped to have an upstream circumferential bulge upstream of the receptacle and a downstream circumferential bulge downstream of the receptacle.

[0272] In some implementations, the device further includes a permeable material disposed over the skirt, the permeable material configured to define at least a part of the adhesive receptacle between the skirt and the tissue.

[0273] In some implementations, the permeable material defines a circumferential boundary of the adhesive receptacle.

[0274] In some implementations, the permeable material defines a toroidal adhesive receptacle between the skirt and the tissue.

[0275] In some implementations, the permeable material has a greater absorbency than the skirt. In some implementations, the material either (1) has a greater porosity than the skirt, or (2) is more hydrophilic than the skirt, or (3) has / is both.

[0276] In some implementations, the delivery tool is configured to dispense the adhesive, via the nozzle, between the skirt and the tissue such that some of the adhesive permeates the material and contacts the tissue.

[0277] In some implementations, the delivery tool is configured to dispense the adhesive, via the nozzle, to the permeable material such that some of the adhesive permeates the material and contacts the tissue.

[0278] In some implementations, the device includes a pair of cushions, each cushion disposed on the skirt.

[0279] In some implementations, the permeable material is disposed over the skirt and each of the cushions, such that the permeable material defines at least a part of the adhesive receptacle between the cushions.

[0280] In some implementations, the delivery tool is configured to dispense the adhesive, via the nozzle, between the cushions and the tissue such that some of the adhesive permeates the material and contacts the tissue

[0281] In some implementations, the pair of cushions includes an upstream cushion and a downstream cushion, such that the permeable material defines at least part of a circumferential adhesive receptacle between the cushions and the tissue.Attorney Docket No: TMTTMT- 24122WO01

[0282] In some implementations, the adhesive receptacle defines a pocket between the skirt and the permeable material. In some implementations, the nozzle opens into the pocket. In some implementations, the delivery tool is configured to dispense the adhesive, via the nozzle, between the skirt and the tissue by dispensing the adhesive into the pocket such that some of the adhesive permeates the material and contacts the tissue.

[0283] In some implementations, the pocket circumscribes the skirt.

[0284] In some implementations, the pocket is shaped to define a ring-shaped sleeve disposed on a radial portion of the skirt.

[0285] In some implementations, the pocket circumscribes a downstream portion of the device.

[0286] In some implementations, the delivery tool includes a catheter, transluminally advanceable to the heart. In some implementations, the device includes a shape-memory frame. In some implementations, the device has a compressed state in which the device is transluminally advanceable, via the catheter, to the heart. In some implementations, the device has an expanded state in which an external diameter of the device is greater than an internal diameter of the native valve, such that a radial portion of the device presses towards tissue of the native valve.

[0287] In some implementations, while the device is in the compressed state, the frame has a tubular shape extending along a longitudinal axis. In some implementations, while the device is in the expanded state, a first portion of the frame extends along the longitudinal axis, and a second portion of the frame extends radially away from the longitudinal axis.

[0288] In some implementations, while the device is in the compressed state, the frame has a tubular shape defining a medially-facing tube-interior and a radially-facing tube-exterior. In some implementations, while the device is in the expanded state, a portion of the tube-interior defines a radially -facing portion of the frame.

[0289] In some implementations, while the device is in the compressed state, the shapememory frame has a tubular shape extending, along a longitudinal axis, from a proximal end to a distal end. In some implementations, while the device is in the expanded state, a portion of the frame defines a toroidal space, circumscribing the longitudinal axis of the frame.

[0290] In some implementations, the system further includes a restraining element inhibiting expansion of an upstream portion of the device. In some implementations, the delivery tool is configured to secure the device in the heart by one or both of (1) transluminally advancing theAttorney Docket No: TMTTMT- 24122WO01device to the heart, and / or (2) while the restraining element inhibits expansion of the upstream portion of the device, positioning the device such that: a downstream portion of the device faces tissue of the native valve.

[0291] In some implementations, the delivery tool is configured to secure the device in the heart by adjusting each of the restraining elements such that the device transitions toward the expanded state. In some implementations, this is done such that the radial portion of the device presses towards tissue of the native valve, and / or involves, subsequently, securing the device in the heart by adhering the skirt to the tissue.

[0292] In some implementations, the restraining element is a first restraining element of a plurality of restraining elements. In some implementations, each restraining element inhibits or is configured to inhibit expansion of an upstream portion of the device. In some implementations, the delivery tool is configured to transluminally advance the device to the heart. In some implementations, the delivery tool is configured to, while the restraining elements inhibit expansion of the upstream portion of the device, position the device such that: the downstream portion of the device faces tissue of the native valve.

[0293] In some implementations, the delivery tool is configured to secure the device in the heart by adjusting each of the restraining elements such that the device transitions toward the expanded state, such that the radial portion of the device presses towards tissue of the native valve.

[0294] In some implementations, the delivery tool is configured to secure or further secure the device in the heart by adhering the skirt to the tissue.

[0295] In some implementations, the delivery tool is configured to secure the device in the heart by adhering the device to the tissue by dispensing the adhesive in contact with the skirt and the tissue, prior to releasing the restraining element from the device.

[0296] In some implementations, the delivery tool includes the restraining element, and is configured to be withdrawn from the subject, leaving the device secured in the heart.

[0297] In some implementations, the restraining element is nonmetallic.

[0298] In some implementations, the restraining element is more flexible than the frame.

[0299] In some implementations, the restraining element is reversibly coupled to a nonmetallic portion of the device.Attorney Docket No: TMTTMT- 24122WO01

[0300] In some implementations, the restraining element includes a cord, coupled to at least three points along a perimeter of the upstream portion. In some implementations, the delivery tool defines a distal portion reversibly coupled to the cord. In some implementations, the delivery tool is configured to transcardially control expansion of the device toward the expanded state by controlling tension on the cord.

[0301] In some implementations, the delivery tool is configured to disengage from the cord and to withdraw from the subject, leaving the cord and the device within the subject.

[0302] In some implementations, the delivery tool is configured to facilitate expansion of the device by reducing tension on the cord.

[0303] In some implementations, the frame defines a plurality of eyelets at the upstream portion. In some implementations, the cord is a first cord, threaded at the least three eyelets of the plurality in a first arc around the perimeter. In some implementations, the cord is threaded and / or configured such that transcardially controlling tension on the first cord controls expansion of a first sector of the perimeter. In some implementations, the system further includes a second cord, threaded through at least three eyelets of the plurality in a second arc around the perimeter. In some implementations, the second cord is threaded and / or configured such that transcardially controlling tension on the second cord controls expansion of a second sector of the perimeter.

[0304] In some implementations, the delivery tool is operatively coupled to the first and second cords to, by transcardially controlling tension on the first and second cords independently of each other, control expansion of the first and second sectors independently of each other.

[0305] Any of the above systems, assemblies, devices, apparatuses, components, etc. can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise (or additional methods comprise or consist of) sterilization of one or more systems, devices, apparatuses, components, etc. herein (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.).

[0306] Any of the above method(s) and any methods of using the systems, assemblies, apparatuses, devices, etc. herein can be performed on a living subject (e.g., human or other animal) or on a simulation (e.g., a cadaver, cadaver heart, imaginary person, simulator, etc.). With a simulation, the body parts can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, etc.) and can optionally comprise computerized and / or physical representations.Attorney Docket No: TMTTMT- 24122WO01

[0307] The present invention will be more fully understood from the following detailed description of applications thereof, taken together with the drawings, in which:BRIEF DESCRIPTION OF THE DRAWINGS

[0308] Figs. 1A-B, 2, 3A-F, 4A-C, 5A-D, 6-7 and 8A-B are schematic illustrations showing implants and use of delivery tools to deploy the implants, in accordance with some implementations.DETAILED DESCRIPTION OF EMBODIMENTS

[0309] The present disclosure includes different variants of some elements. Variants of a given element typically have the same structure and / or function as each other except for any differences described. For any given element for which different variants are disclosed, the identical name is used for each variant, in order to denote that they are, in fact, variants the same given element. Unless stated otherwise, applications of the devices, systems, and techniques described herein may include any arrangement in which one variant of an element is substituted with another identically-named variant of that element. Furthermore, throughout the figures, suffixes are used to denote different variants of the same element. Unless stated otherwise, such variants may be substituted with each other, mutatis mutandis. That is, unless stated otherwise, any element having a given reference numeral may be substituted with any other element (i.e., any other variant of the element) having the same reference numeral, independent of any suffix.

[0310] In order to avoid undue clutter from having too many reference numbers and lead lines on a particular drawing, some elements are introduced via one or more drawings and not explicitly identified in every other drawing that contains that element.

[0311] Reference is made to Figs. 1A-B, 2, 3A-F, 4A-C, 5A-D, 6-7 and 8A-B, which are schematic illustrations showing devices or implants 200, 200a, 200b, 200c, docking stations 300, 300a, 300b, 300d and use of delivery tools 120, 120a, 120b, 120d in accordance with some implementations;

[0312] Figs. 1A-B and 2 show device 200 comprising a prosthetic valve 400 and a docking station 300 comprising a frame 320 and a skirt 340. Fig 1 A shows prosthetic valve 400 separate from docking station 300, and Fig. IB shows the prosthetic valve seated within the docking station, as described hereinbelow.Attorney Docket No: TMTTMT- 24122WO01

[0313] In some implementations, and as shown in Fig. 1A, prosthetic valve 400 is shaped to define a tubular valve lumen 460 that extends from the prosthetic valve's upstream portion 402 to the prosthetic valve's downstream portion 404. In some implementations, and as shown, prosthetic valve 400 comprises a plurality of prosthetic leaflets 450, e.g., joined together at commissures 470 to facilitate monodirectional flow of blood through valve lumen 460. In some implementations, and as shown, prosthetic valve 400 comprises a valve frame 420 to which leaflets 450 are coupled, e.g., at commissures 470. In some implementations, and as shown, prosthetic valve 400 comprises a valve skirt 440 within which leaflets 450 are seated.

[0314] Fig. 2 is an exploded view of docking station 300, showing the docking station's frame 320 and skirt 340 separately. In some implementations, frame 320 comprises a compressible, shape memory material. In accordance with some such implementations, Fig. 2 shows frame 320 in an expanded state that the frame assumes while deployed in the heart. In this way, docking station 300 can be self-expanding, e.g., as described hereinbelow with reference to Figs. 3D-E.

[0315] In some implementations, and as shown, frame 320 defines a central stent 326 that extends along an upstream-downstream axis al from an upstream portion 322 of the frame to a downstream portion 324 of the frame. In some implementations, and as shown, upstream portion 322 of frame 320 comprises posts 335 that define eyelets 333, as described hereinbelow with reference to Figs. 4A-C and 5A-D. In some implementations, and as shown, frame 320 further defines radial arms 328 that extend radially away from axis al, e.g., at the frame's downstream portion 324. For example, and as shown, the frame's radial arms 328 can extend, at the frame's downstream portion 324 (i) radially away from central stent 326, and (ii) toward the frame's upstream portion 322.

[0316] In some implementations, and as shown, skirt 340 is shaped to define a tubular portion 346 shaped to fit the frame's stent 326, e.g., such that the tubular portion and the stent together form a tubular dock 330 (Fig. 1 A). In some implementations, and as shown in Fig. IB, dock 330 is shaped to receive prosthetic valve 400 therewithin, to facilitate monodirectional flow of blood through the dock.

[0317] In some implementations, skirt 340 comprises a flexible material, e.g., a flexible fabric, that is coupled to frame 320 such that the skirt yields to the frame's shape. In some implementations, skirt 340 resists flow of blood therethrough. In some implementations, and as shown in Figs. 1 A-B, skirt 340 (e.g., radial portion 348 thereof) circumscribes a downstreamAttorney Docket No: TMTTMT- 24122WO01portion 324 of dock 330, to inhibit flow of blood through downstream portion 304 of docking station 300, e.g., through frame 320, radially of the dock. In some implementations, and as shown, radial portion 348 of skirt 340 is shaped and / or is sufficiently flexible to fit the frame's radial arms 328.

[0318] In some implementations, and as shown, docking station 300 comprises a pair of cushions (or other bulges) 312, 314 that are shaped to circumscribe the skirt's radial portion 348. For example, and as shown, an upstream cushion (or bulge) 312 can circumscribe the docking station's upstream portion 302, and a downstream cushion (or bulge) 314 can circumscribe the docking station's downstream portion 304.

[0319] In some implementations, cushions 312, 314 protrude radially from the skirt's radial portion 348, e.g., such that the cushions contact the atrial wall when docking station 300 is deployed to atrium 4 (Fig. 3 A). In some implementations, and as shown in the inset of Fig. 3A, cushions 312, 314 define a circular cross-section protruding radially from the skirt's radial portion 348.

[0320] In some implementations, skirt 340 and cushions 312, 314 inhibit the flow of blood therethrough, e.g., such that the skirt and the cushions inhibit leakage of blood between device 200 and the wall of atrium 4 of heart 2. In some implementations, skirt 340 and cushions 312, 314 are also relatively impervious to adhesive 160, such that the skirt and cushions inhibit flow of the adhesive therethrough. In this way, skirt 340 and cushions (or bulges) 312, 314 can define a receptacle 370, e.g., circumscribing docking station 300, at or within which adhesive 160 can be applied, between the skirt and the atrial wall (Fig. 3B). For example, and as shown, receptacle 370 can define a toroidal space between skirt 340 (e.g., radial portion 348 thereof) and the atrial wall. In some implementations, and as shown, nozzle(s) 154 are disposed at skirt 340 axially between the cushions (or bulges).

[0321] Figs. 3A-F show use of a system 100 comprising delivery tool 120 to secure device 200 within atrium 4, upstream of a native valve 10 of the heart. In some implementations, and as shown, docking station 300 is mounted (e.g., rigidly mounted) to the delivery tool's distal portion 124. In accordance with some implementations, and as shown, a central arm 140 extends distally from catheter 130 into central lumen 360 of docking station 300, e.g., where arm 140 reversibly interfaces (not shown) with the docking station. In some implementations, docking station 300 is rigidly mounted to central arm 140, e.g., the central arm is more rigid than the docking station, such as frame 320 thereof.Attorney Docket No: TMTTMT- 24122WO01

[0322] In accordance with some implementations, docking station 300 is shown being implanted at a left atrium 4 of the heart, upstream of mitral valve 10, such that the wall of atrium 4 circumscribes the docking station's skirt 340. However, docking station 300 may be implanted elsewhere in heart 2, e.g., at a right atrium, upstream of the tricuspid valve, mutatis mutandis.

[0323] In some implementations, and as shown, device 200 is deployed at atrium 4 in at least two steps: (i) docking station 300 is secured to the atrium (Fig. 3A-C), after which (ii) prosthetic valve 400 is seated within the docking station (Fig. 3D-F). In some implementations, prosthetic valve 400 is seated within docking station 300 shortly after docking station 300 is secured to atrium 4, e.g., during the same medical procedure as securing the docking station. In some implementations, prosthetic valve 400 can be seated within docking station 300 in a subsequent medical procedure. For example, 2-10 weeks may be allowed to pass between implanting docking station 300 and seating prosthetic valve 400, e.g., in order to allow for tissue ingrowth to strengthen a bond between the docking station and the atrial wall.

[0324] Fig. 3A shows docking station 300 having been transluminally advanced, via catheter 130 of delivery tool 120, into atrium 4. In some implementations, delivery tool 120 is shown having a proximal controller 122 from which the tool is operated and a distal portion 124 from which docking station 300 is deployed, e.g., from a distal end of catheter 130.

[0325] In some implementations, docking station 300 is transluminally delivered through catheter 130 while the docking station is in a compressed state in which frame 320 has a tubular shape extending along an upstream-downstream axis. In some implementations, frame 320 comprises a shape-memory material that expands docking station 300, upon release from catheter 130, into an expanded state. For example, while the docking station is in the compressed state (not shown), frame 320 can have a tubular shape defining a medially-facing tube-interior and a radially-facing tube-exterior, and while the docking station is in the expanded state (Fig. 3A), a portion of the tube-interior defines a radially-facing portion of the frame, e.g., defining the frame’s radial arms 328. In this way, and as shown in Fig. 3 A, a portion of frame 320 (e.g., radial arms 328) defines a toroidal space circumscribing the docking station's tubular dock 330.

[0326] In some implementations, and as shown in the perspective view of docking station 300 in inset of Fig. 3 A, cushions 312, 314 protrude radially from the skirt's radial portion 348, which together define receptacle 370. In some implementations, and as shown, delivery tool 120 comprises an adhesive applicator 150 (e.g., a plurality of applicators, such as a pair ofAttorney Docket No: TMTTMT- 24122WO01applicators) that extend distally from catheter 130 such that each applicator's distal portion 154 is disposed within receptacle 370. For example, and as shown, applicator 150 extends through skirt 340 and / or one of cushions 312, 314, such that nozzle 153 (while the term “nozzle” is used herein, this encompasses a variety of connectors or pathways configured in a variety of ways) is in fluid communication with receptacle 370.

[0327] The main frame of Fig. 3A shows a cross-sectional view of docking station 300 within atrium 4, in which the skirt's radial portion 348, together with cushions 312, 314 define receptacle 370 against the atrial wall. In accordance with some implementations, docking station 300 is positioned upstream of native valve 10, such that that the docking station's downstream portion 304 faces the native valve's inlet. In some implementations, docking station 300 is positioned so as to reduce or eliminate the docking station's interference with functioning of native valve 10.

[0328] In some implementations, and as shown cushions 312, 314 and / or skirt 340 are pressed against the atrial wall. In some implementations, an external diameter of docking station 300, when allowed to unrestrictedly expand, may be greater than an internal diameter of atrium 4, such that the docking station's frame 320 is partially compressed after deployment to the atrium. In this way, the frame's shape memory presses skirt 340 (e.g., radial portion 348 thereof) and / or cushions 312, 314 against the atrial wall.

[0329] In accordance with some implementations, Fig. 3B shows adhesive 160 having been dispensed from each applicator's nozzle 153 into receptacle 370. In some implementations, cushions 312, 314 and skirt 340 (at least radial portion 348 thereof) are largely impervious to adhesive 160. In this way, adhesive 160 that is introduced into receptacle 370 is kept from leaking (i) medially through the skirt, or (ii) up- or down-stream through cushions 312, 314. For example, the adhesive may remain within receptacle 370 and / or be absorbed into tissue of the atrial wall that faces the skirt.

[0330] In some implementations, adhesive 160 provides additional mechanical strength and / or stability to docking station 300, e.g., such that the docking station's frame 320 may include less material than would be required in absence of the adhesive. Alternatively or in addition, adhesive 160 can electrically insulate docking station (e.g., frame 320 thereof) from tissue of the heart, to reduce influence of the frame's conductivity upon electrophysiological signaling in the heart.Attorney Docket No: TMTTMT- 24122WO01

[0331] In some implementations, adhesive 160 is actively cured, in order to strengthen the bond between docking station 300 and the atrial wall, prior to seating prosthetic valve 400 in dock 330. In some implementations, a curing sleeve (not shown) is advanced via catheter 130 to receptacle 370, in order to accelerate curing of adhesive 160. For example, the curing sleeve may emit a curing energy (e.g., ultraviolet or infra-red radiation) and / or may deliver a curing reagent, to accelerate curing of adhesive 160.

[0332] In accordance with some implementations, Fig. 3C shows arm 140 and applicators 150 having been withdrawn into catheter 130. In some implementations, catheter 130 is also withdrawn (e.g., delivery tool 120 in its entirety is removed from the subject) and a period of time (e.g., 2-10 weeks) is allowed to pass before prosthetic valve 400 is seated within the docking station's dock 330, e.g., in a subsequent medical procedure. In some implementations, catheter 130 can be kept in place and prosthetic valve 400 can be seated within dock 330 (Fig.3D-E) during the same medical procedure.

[0333] In accordance with some implementations, after docking station 300 is secured in atrium by adhering skirt 340 and / or cushions 312, 314 to the atrial wall, prosthetic valve 400 is seated within the docking station's dock 330. In accordance with some such implementations, Fig. 3D shows a compressed prosthetic valve 400 being advanced out of catheter 130 (e.g., along the delivery tool's arm 140), towards the docking station's dock 330, and Fig. 3E shows the expanded prosthetic valve having been seated within the dock.

[0334] Fig. 3F shows catheter 130 having been retracted from atrium 4, as delivery tool 120 is withdrawn from the subject and implant 200 remains in atrium 4, upstream of native valve 10. In some implementations, dock 330 and the prosthetic valve's leaflets 450 remain upstream of native valve 10 as the native valve reciprocatingly transitions between ventricular systole and ventricular diastole. In this way, implant 200 can facilitate monodirectional flow of blood through the native valve, while allowing the native valve to continue to function, e.g., by allowing the native leaflets to at least partially coapt.

[0335] In accordance with some implementations, Figs. 4A-C and 5A-D respectively show use of delivery tools 120a, 120b to implant docking stations 300a, 300b at atrium 4. Delivery tools 120a, 120b can be considered to be variants of delivery tool 120, and components bearing identical reference numerals are typically interchangeable between delivery tools 120, 120a, 120b. Delivery tools 120, 120a, 120b can be similar, at least in their general purpose, i.e., securing docking station 300a, 300b in the atrium, except that distal portions 124a, 124b ofAttorney Docket No: TMTTMT- 24122WO01delivery tools 120a, 120b each comprise a restraining element 170a, 170b. Furthermore, docking stations 300a, 300b can be considered to be variants of docking station 300, and can be similar, at least in their general purpose, i.e., receiving prosthetic valve 400a, 400b into dock 330 while the docking station is adhered to the tissue 3 of the atrial wall.

[0336] As such, the description below of delivery tools 120a, 120b focuses upon use of restraining element 170a, 170b in deployment and implantation of docking stations 300a, 300b. Although restraining elements 170a, 170b are described hereinbelow in use for deploying docking stations 300a, 300b, use of the restraining elements to deliver prosthetic valve 400a, 400b and / or seat the prosthetic valve into dock 330 is contemplated, mutatis mutandis.

[0337] In accordance with some implementations, and as shown in Figs. 4A and 5A, docking station 300a, 300b has been transluminally advanced, via delivery tool 120a, 120b to atrium 4. In some implementations, and as shown, each docking station 300a, 300b is deployed such that while restraining elements 170a, 170b restrain upstream portion 302a, 302b (e.g., the frame's central stent) of the docking station from fully radially expanding, the docking station's downstream portion 304a, 304b expands radially into position within atrium 4. For example, and as shown, the atrial wall circumscribes skirt 340 and dock 330 is disposed upstream of the native valve.

[0338] In some implementations, restraining element 170a, 170b is flexible, e.g., comprising a nonmetallic material such as cord. In some implementations, coupling docking station 300a, 300b to delivery tool 120a, 120b by flexible material such as cord may facilitate (i) articulation of the docking station with respect to the delivery tool, and / or (ii) use of less material in frame 320 (e.g., a frame of shorter length) than would be required in absence of the cord.

[0339] In some implementations, and as shown, restraining element 170a comprises a plurality of cords (e.g., three cords 174e, 174f, 174g), each of which is coupled to at least three points along the docking station's upstream portion 302a, e.g., along an arc of perimeter of dock 330. In this way, each cord constrains respective segments of the docking station's upstream portion 302a from fully expanding.

[0340] In some implementations, and as shown in the inset of Fig. 4A, each cord 174e, 174f, 174g extends from within the delivery tool's deployment catheter 140a and is threaded through eyelets 333 defined by the frame's posts 335. In this way, tension on each cord 174e, 174f, 174g can be individually adjusted (e.g., via the delivery tool's proximal controller 122), so as toAttorney Docket No: TMTTMT- 24122WO01individually regulate expansion of respective portions of the docking station's upstream portion 302a.

[0341] In accordance with some implementations, cords 174e, 174f, 174g are tensioned in Fig.4A, and releasing the tension allows docking station 300a to further radially expand (inset of Fig. 4B), thereby pressing skirt 340a (e.g., radial portion 348a thereof) against the atrial wall. In some implementations, tension on each cord 174e, 174f, 174g can be individually adjusted.

[0342] In some implementations, and as shown in Fig. 4C, after releasing tension on cords 174e, 174f, 174g, the cords are unthreaded (e.g., each cord can be individually unthreaded) from eyelets 333 and retracted back into deployment catheter 140a. In accordance with some implementations, Fig. 4C also shows adhesive 160 having been applied to receptacle 370, thereby adhering the docking station's skirt 340a (e.g., radial portion 348a thereof) to the atrial wall, as described hereinabove with reference to Fig. 3B.

[0343] In accordance with some implementations, Fig. 4C shows prosthetic valve 400a having been seated with the docking station's dock 330a (e.g., such as described hereinabove with reference to Figs 3D-E), such that the docking station and the prosthetic valve together form device 200a. In this way, delivery tool 120a can be withdrawn from the subject, leaving docking station 300a secured to tissue 3 of the atrial wall.

[0344] In accordance with some implementations, Fig. 5A shows the delivery tool's distal portion 12b coupled to docking station 300b via restraining element 170b. In some implementations, and in contrast to cords 174e, 174f, 174g of restraining element 170a, restraining element 170b comprises restraining amis 171 (e.g., three restraining arms, as shown) that are each coupled to docking station 300b.

[0345] In accordance with some implementations, and as readily visible in Fig. 5B, restraining arms 171 are coupled to docking station 300b at a cord 174b that is integral to the docking station. In some implementations, and as shown, cord 174b is threaded through the eyelets 333 of the docking station's frame 320. However, in contrast to cords 174e, 174f, 174g, cord 174b remains threaded through the eyelets, even after withdrawal of delivery tool 120b.

[0346] In some implementations, and as shown in the inset of Fig. 5A, cord 174b is removably threaded through each restraining arm 171, e.g., at a distal portion 178 of each arm. In some implementations, and as shown schematically in the inset of Fig. 5 A, a connecting wire 172 (e.g., a distal portion 173 thereof) blocks release of cord 174b from restraining arm 171.Attorney Docket No: TMTTMT- 24122WO01

[0347] In some implementations, restraining arms 171 are each controllable (e.g., individually controllable) via controller 122, and Fig. 5A shows distal portion 178 of each restraining arm oriented to prevent the docking station's upstream portion 302 from fully expanding. In some implementations, and as shown, the restraining arms' distal portions 178 are held in tension with sufficient force to resist expansion of the docking station's upstream portion 302. For example, and as shown in the inset of Fig. 5 A, arms 171 hold cord 174b in tension, in order to constrain the docking station's upstream portion 302b from fully radially expanding.

[0348] In some implementations, and as shown in Fig. 5B, the distance between distal portions 178 of restraining arms 171 is increased (e.g., via controller 122), such that docking station 300b is allowed to expand, thereby pushing skirt 340 against tissue 3 of the atrial wall. In some implementations, and as shown in Fig. 5C, if the clinician is satisfied with the placement of docking station 300b within atrium 4, adhesive 160 can be used to adhere docking station 300b to atrium 4, e.g., as described hereinabove with reference to docking station 300.

[0349] In some implementations, and as shown in Fig. 5C, restraining arms 171 can then be released from the docking station, e.g., by the arms releasing cord 174b. For example, and as shown in the inset of Fig. 5C, connecting wire 172 is retracted (e.g., via controller 122), such that restraining arms 171 can be retracted into deployment catheter 140b.

[0350] In some implementations, and as shown in Fig. 5D, prosthetic valve 400b is then seated within dock 330 to form device 200b, e.g., as described hereinabove with reference to device 200.

[0351] In some implementations, Fig. 6 shows device 200c, which can be the same as or similar to device 200, with the exception that device does not comprise a distinct docking station 300 and prosthetic valve 400.

[0352] In some implementations, and as shown, device 200c has a central valve portion 230c from which a radial portion 240c extends radially. In some implementations, and as shown, skirt 340c (e.g., radial portion 348c thereof) is spaced radially from valve portion 230c.

[0353] In some implementations, the frame's radial portion 328c (e.g., the frame's radial arms) maintains skirt 340c spaced radially from portion 230c. For example, and as shown, the skirt's tubular portion 346c circumscribes portion 230c, and the skirt's radial portion 348c circumscribes radial portion 240c.

[0354] In some implementations, certain adaptations of device 200 may be applied to device 200c. For example, and as shown, tubular portion 346 of skirt 340 may obviate valve skirt 440,Attorney Docket No: TMTTMT- 24122WO01which is not shown in Fig. 6. Alternatively or in addition, certain adjustments may be made to account for the lack of the prosthetic valve's valve frame 420 (shown extending upstream from the docking station's frame 420 in Fig. IB) in device 200c. For example, the docking station's central stent 326c may extend further upstream (e.g., frame 320c may have a greater height than frame 320) in order to support leaflets 450c, and / or commissures 470 may be reinforced by other means (e.g., suturing).

[0355] In some implementations, and as shown, device 200c (e.g., respective cushions 312, 314 thereof) defines an upstream circumferential bulge 311 at an upstream portion of the skirt's radial portion 348c, and a downstream circumferential bulge 313 at a downstream portion of the skirt's radial portion.

[0356] In some implementations, and as shown, leaflets 450c (e.g., similar to leaflets 450 of prosthetic valve 400) are directly fixed (e.g., sewn) to frame 320c at commissures 370c, as described hereinabove with reference to docking station 300. Other elements of device 200 may be identical to those of docking station described previously, and those elements are therefore marked in Fig. 6 with identical reference numerals. In some implementations, delivery tool 120 can be used to implant device 200c similarly to as described hereinabove regarding the implantation of docking station 300, mutatis mutandis.

[0357] In accordance with some implementations, Figs. 7 and 8A-B show docking station 300d and use of delivery tool 120d to implant docking station 300d at atrium 4. Although docking station 300d is shown being implanted in atrium 4, other deployment positions (e.g., in which the permeable material's upstream portion 352d at the docking station's upstream portion 322d is seated at the native valve's annulus, and the permeable material's downstream portion 354d at the docking station's downs stream portion 324d contacts the native valve's leaflets 12) are contemplated, mutatis mutandis.

[0358] Delivery tool 120d can be considered to be a variant of delivery tool 120, and can be similar to delivery tool 120, at least in its general purpose, i.e., to adhere device 200c and / or docking station 300d to the heart. Delivery tool 120d is in many ways identical to delivery tool 120 described hereinabove, except that delivery tool 120d is shown in Fig. 7 having a greater number of adhesive applicators 150 than delivery tool 120. In some implementations, and as shown, applicators 150 diverge from each other distally (e.g., from catheter 130), such that nozzles 153 of the applicators are distributed circumferentially around skirt 340d, e.g., radial portion 348d thereof. For example, six applicators 150 are visible in the foreground of Fig. 7,Attorney Docket No: TMTTMT- 24122WO01e.g., such that delivery tool 120d may have a total of twelve applicators. However, this is a merely representative example, and fewer applicators (e.g., 2-12 applicators, such as 6-12 applicators) or more applicators (e.g., 13-20 applicators) are contemplated. Alternatively, each individual adhesive applicator 150 may be considered to collectively comprise a single applicator that defines several nozzles 153 that diverge from each other circumferentially around the skirt at the applicator's distal portion.

[0359] Docking station 300d can be considered to be a variant of docking station 300, and can be similar to docking station 300, at least in its general purpose, i.e., to facilitate monodirectional flow of blood through the native valve by receiving prosthetic valve 400 within dock 330 while the docking station is implanted at native valve 10.

[0360] In some implementations, and as shown, device 200c and docking station 300d respectively differ from device 200 and docking station 300 in that device 200c and docking station 300d each comprises a permeable material 350c, 350d disposed over skirt 340c, 340d, e.g., to define a pocket 355 between skirt 340 and the material.

[0361] In accordance with some implementations, docking station 300d is shown without cushions 312, 314 of docking station 300. However, permeable material 350c, 350d is compatible with the cushions, as shown above in Fig. 6 regarding device 200c. In some such implementations, the device's upstream circumferential bulge 311 and downstream circumferential bulge 313 (e.g., respective cushions 312, 314) circumscribe the skirt's radial portion 348c, between the skirt and permeable material 350c.

[0362] In some implementations, and as shown in the cross-section inset of Fig. 7, pocket 355 circumscribes skirt 340, e.g., radial portion 348d thereof. For example, pocket 355 can define a sleeve, e.g., a ring-shaped sleeve. In some implementations, pocket 355 defines receptacle 370d of docking station 300d, and nozzles 153 open into the pocket in order to place applicators 150 in fluid communication with receptacle 370d, e.g., nozzle 153 is disposed at receptacle 370d, as shown in the inset of Fig. 7.

[0363] In some implementations, dispensing adhesive 160 via nozzles 153 to material 350d causes the adhesive to permeate the material, e.g., such that the permeable material itself defines part of receptacle 370d. In some implementations, and as shown, permeable material 350d defines a boundary (e.g., a radial boundary) of receptacle 370d. In some such implementations, and as shown in Figs. 7 and 8A-B, material 350d defines a circumferential boundary ofAttorney Docket No: TMTTMT- 24122WO01receptacle 370, e.g., such that the receptacle includes a toroidal space of pocket 355, and / or the permeable material itself.

[0364] In some implementations, docking station 300d comprises cushions 312, 314 (not shown with reference to docking station 300d) described hereinabove. In some such implementations, cushions 31 , 314 define a boundary of receptacle 370d in conjunction with permeable material 350d. In this way, docking station 300d can be implanted upstream of native valve 10 such that permeable material 350d defines receptacle 370d between cushions 312, 314 and atrial tissue (Figs. 8A-B).

[0365] In some implementations, material 350d has a greater absorbency and / or permeability than skirt 340, such that, when docking station 300d is deployed in heart 2, at least a portion of adhesive applied to receptacle 370d tends to permeate the material and contact tissue 3 of the heart (e.g., to the atrial wall, as shown), thereby adhering the docking station to the tissue (Figs.8A-B).

[0366] For example, the permeability of material 350d to adhesive 160 may be due to the material's porosity, e.g., the material may comprise a more loosely woven fabric than skirt 340. Alternatively or in addition, material 350d may be more hydrophilic than skirt 340, such that a water-based adhesive would more readily permeate the material than the skirt.

[0367] In some implementations, permeable material 350d is chemically modified or otherwise pre-treated (e.g. prior to its incorporation in the device or docking station) to react with adhesive 160. For example, adhesive 160 may be a functionalized adhesive, such as a functionalized PEG-based adhesive described hereinabove, which may covalently bond to the pre-treated / chemically-modified material 350d. Adhesive 160 can thereby serve as a bridge between material 350d and tissue of the heart. That is, material 350d can be chemically modified such that adhesive 160 will bond to the material similarly to as the adhesive will bond to the tissue.

[0368] In some implementations, material 350d is coated with a protein (e.g., albumin) and / or a mucoadhesive polymer, to which the functionalized adhesive will bond. For example, adhesive 160 may be configured to bond to hydroxide, amino groups and / or sulfhydryl groups of the protein coating on the fabric's surface. In some implementations, selective pretreatment of certain portions of material 350d (e.g., upstream portion 352d and / or downstream portion 354d) can predetermine to which portion(s) of the material adhesive 160 will bond.Attorney Docket No: TMTTMT- 24122WO01

[0369] In some implementations, material 350d comprises a fabric, such as polyethylene terephthalate (PET) that has been chemically modified during the pretreatment to bond to adhesive 160. For example, material 350d can be exposed to an oxidizing agent, such as benzoyl peroxide, and / or an energy source such as UV light, in the presence of substrates such as ammonia, nitrogen, oxygen, and / or cysteamine, to covalently bond the substrate to the fabric, thereby providing hydroxide, amino groups and / or sulfhydryl groups on the fabric's surface to which the functionalized adhesive will bond.

[0370] In some implementations, a hydroscopic hydrogel (e.g., comprising pectin and / or carboxymethylcellulose) can be conjugated to material 350d during the pretreatment. In some implementations, the hydrogel swells upon exposure to predetermined conditions (e.g., moisture, temperature and / or pH) such that the hydrogel will swell in situ, filling any gap that might form between material 350d and the tissue. In some such implementations, the hydrogel can be pretreated such that exposure to adhesive 160 activates the hydrogel, e.g., causing the hydrogel to absorb water, and therefore to swell.

[0371] In some implementations, material 350d obviates cushions 312, 314 of docking station 300. That is, the permeability of material 350d (or at least upstream-facing portion 352d and downstream-facing portion 354d thereof) may be sufficiently limited to prevent an unacceptable quantity of adhesive leaking upstream or downstream, e.g., into the atrium. Although Figs. 7 and 8A-B show use of sleeve-shaped receptacle 370d without the cushions, material 350d is not incompatible with cushions 312, 314, and use of the material in conjunction with the cushions is contemplated.

[0372] In some implementations, docking station 300d is deployed or implanted in atrium 4 similarly to docking station 300 described hereinabove. In some implementations, and as shown in Fig. 8A, and similarly to skirt 340 of docking station 300, skirt 340d may be considered to press against the tissue 3 of the atrial wall, despite material 350d being disposed between the skirt and the wall. Implantation of docking station 300d will therefore be described with focus upon features that differentiate implantation of docking station 300d from that of docking station 300.

[0373] In accordance with some implementations, and similarly to docking station 300 shown in Fig. 3A, Fig. 8A shows the delivery tool's central arm 140 extending distally from catheter 130 into the central lumen of docking station 300d. As shown, docking station 300d has expanded from its compressed state, such that the docking station (e.g., material 350d thereof)Attorney Docket No: TMTTMT- 24122WO01contacts the wall of atrium 4. In some implementations, and as shown, distal end portions 154 of applicators (e.g., defining nozzles 153) are disposed within receptacle 370 that is defined by pocket 355.

[0374] In accordance with some implementations, Fig. 8B shows docking station 300d having been secured to the atrial wall, upstream of native valve 10. In accordance with some such implementations, and as shown in the inset of Fig. 8B, adhesive 160 occupies receptacle 370d, further pressing material 350d against the atrial wall.

[0375] In some implementations, a portion of the adhesive migrates radially outward from the receptacle, through material 350d and toward the tissue 3 of the atrial wall. For example, and as shown in the inset of Fig. 8B, a thin layer of adhesive 160' is visible having passed through material 350d and having permeated tissue 3 of the atrial wall, which strengthens the bond between docking station and the atrial wall.

[0376] In some implementations, docking station 300d remains upstream of native valve 10 after prosthetic valve 400 is seated (not shown) in the docking station's dock. In this way, the prosthetic valve's leaflets 450 remain upstream of native valve 10 as the native valve reciprocatingly transitions between ventricular systole and ventricular diastole. In this way, docking station 300d can facilitate monodirectional flow of blood through the native valve, while allowing the native valve to continue to function.

[0377] Example Applications (some non-limiting examples of the concepts herein are recited below):

[0378] Example 1. A system for use with a prosthetic valve at a heart of a subject, the heart having a native valve disposed between an atrium of the heart and a ventricle of the heart, the system comprising: an expandable docking station: defining a dock that is configured to receive a prosthetic valve therewithin, and comprising a skirt circumscribing a downstream portion of the dock; and a delivery tool: comprising an applicator that contains an adhesive and comprises a nozzle that provides fluid communication between the applicator and the skirt, and configured to secure the docking station in the atrium by: transluminally advancing the docking station to the atrium, pressing the skirt against tissue of the atrium around an inlet of the native valve such that the downstream portion of the dock is open toward the inlet of the native valve, and adhering the skirt to the tissue by, via the nozzle, dispensing the adhesive between the skirt and the tissue.Attorney Docket No: TMTTMT- 24122WO01

[0379] Example 2. The system according to example 1, wherein the docking station and the delivery tool are sterile.

[0380] Example 3. The system according to any one of examples 1 -2, wherein the applicator is configured to dispense the adhesive via the nozzle, on a radial portion of the skirt, between the skirt and the tissue.

[0381] Example 4. The system according to any one of examples 1-3, wherein the delivery tool is configured to withdraw the applicator from the docking station, leaving the docking station secured in the atrium.

[0382] Example 5. The system according to any one of examples 1-4, wherein: the docking station comprises a frame that defines a plurality of eyelets distributed circumferentially around a perimeter of the dock; and the system comprises a cord, threaded through consecutive eyelets of the plurality in an arc around the perimeter.

[0383] Example 6. The system according to example 5, wherein the delivery tool: comprises a catheter; and is configured to deploy the docking station from the catheter and into the atrium, via the cord.

[0384] Example 7. The system according to any one of examples 5-6, wherein: the frame is a self-expanding frame; and the delivery tool is configured to control expansion of the frame by controlling tension on the cord.

[0385] Example 8. The system according to example 7, wherein the delivery tool is reversibly coupled to the docking station via the cord, and the delivery tool is configured to disengage from the cord and to withdraw from the subject, leaving the cord and the docking station within the subject.

[0386] Example 9. The system according to example 7, wherein the delivery tool is reversibly coupled to the docking station via the cord, and the delivery tool is configured to: release the docking station by unthreading the cord from the eyelets, and withdraw from the subject, leaving the docking station within the subject.

[0387] Example 10. The system according to any one of examples 7-9, wherein the delivery tool is configured to facilitate expansion of the frame by reducing tension on the cord.

[0388] Example 11. The system according to example 10, wherein: the cord is a first cord, threaded through consecutive eyelets of the plurality in a first arc around the perimeter, such that reducing tension on the first cord facilitates expansion of a first sector of the perimeter, andAttorney Docket No: TMTTMT- 24122WO01the system further comprises a second cord, threaded through consecutive eyelets of the plurality in a second arc around the perimeter, such that reducing tension on the second cord facilitates expansion of a second sector of the perimeter.

[0389] Example 12. The system according to example 11, wherein the delivery tool is operatively coupled to the first and second cords such that, by reducing tension on each of the cords independently of each other, each of the sectors is controllably expandable independently of the other sectors.

[0390] Example 13. The system according to any one of examples 11-12, wherein the delivery tool is configured to: release the docking station within the heart by unthreading each cord from the respective consecutive eyelets, and withdraw from the heart.

[0391] Example 14. The system according to any one of examples 1-13, wherein the skirt is configured to isolate the adhesive between the skirt and the tissue.

[0392] Example 15. The system according to example 14, wherein the docking station is configured to define an adhesive receptacle between the skirt and the tissue.

[0393] Example 16. The system according to example 15, wherein the nozzle provides fluid communication between the applicator and the adhesive receptacle.

[0394] Example 17. The system according to any one of examples 15-16, wherein the adhesive receptacle circumscribes the docking station.

[0395] Example 18. The system according to any one of examples 15-17, wherein the docking station comprises a pair of cushions comprising an upstream cushion and a downstream cushion, each cushion disposed on the skirt such that the pair of cushions and the skirt define the adhesive receptacle.

[0396] Example 19. The system according to any one of examples 1-18, wherein the system further comprises the prosthetic valve, configured to be: transluminally advanceable, via the delivery tool, to the atrium, and seated within the dock such that the prosthetic valve facilitates monodirectional flow of blood through the native valve.

[0397] Example 20. The system according to example 19, wherein the prosthetic valve comprises a plurality of prosthetic leaflets, configured to facilitate monodirectional flow of blood through the native valve, while remaining within the atrium as the native valve reciprocatingly transitions between ventricular systole and ventricular diastole.Attorney Docket No: TMTTMT- 24122WO01

[0398] Example 21. The system according to any one of examples 1-20, further comprising a curing sleeve: transluminally advanceable via the delivery tool, and configured to, after the adhesive is dispensed between the skirt and the tissue, cure the adhesive.

[0399] Example 22. The system according to example 21, wherein the curing sleeve is configured to cure the adhesive by providing a curing reagent to the adhesive.

[0400] Example 23. The system according to any one of examples 21-22, wherein the curing sleeve is configured to cure the adhesive by providing a curing energy to the adhesive.

[0401] Example 24. The system according to any one of examples 1-23, wherein the skirt is configured to inhibit flow of blood through the downstream portion of the docking station.

[0402] Example 25. The system according to example 24, wherein the dock defines a central lumen, and the skirt is configured to inhibit flow of blood through the docking station, radially of the central lumen.

[0403] Example 26. The system according to any one of examples 1-25, wherein the docking station further comprises a permeable material disposed over the skirt to define a pocket between the skirt and the material, the nozzle opening into the pocket, and the delivery tool configured to dispense the adhesive, via the nozzle, between the skirt and the tissue by dispensing the adhesive into the pocket such that some of the adhesive permeates the material and contacts the tissue.

[0404] Example 27. The system according to example 26, wherein the material has a greater porosity than the skirt.

[0405] Example 28. The system according to any one of examples 26-27, wherein the material is more hydrophilic than the skirt.

[0406] Example 29. The system according to any one of examples 26-28, wherein the pocket circumscribes the skirt.

[0407] Example 30. The system according to example 29, wherein the pocket is shaped to define a ring-shaped sleeve disposed on a radial portion of the skirt.

[0408] Example 31. The system according to any one of examples 1-30, wherein: the delivery tool comprises a catheter, transluminally advanceable to the atrium, and the docking station comprises a shape-memory frame, such that the docking station has: a compressed state in which the docking station is transluminally advanceable, via the catheter, to the atrium, and anAttorney Docket No: TMTTMT- 24122WO01expanded state in which an external diameter of the docking station is greater than an internal diameter of the atrium, such that a radial portion of the skirt presses against tissue of the atrium.

[0409] Example 32. The system according to example 31, wherein: while the docking station is in the compressed state, the shape-memory frame has a tubular shape extending along a longitudinal axis, and while the docking station is in the expanded state, a first portion of the frame extends along the longitudinal axis, and a second portion of the frame extends radially away from the longitudinal axis.

[0410] Example 33. The system according to any one of examples 31-32, wherein: while the docking station is in the compressed state, the shape-memory frame has a tubular shape defining a medially-facing tube-interior and a radially-facing tube-exterior, and while the docking station is in the expanded state, a portion of the tube-interior defines a radially-facing portion of the frame.

[0411] Example 34. The system according to any one of examples 31-33, wherein: while the docking station is in the compressed state, the shape -memory frame has a tubular shape extending, along a longitudinal axis, from a proximal end to a distal end, and while the docking station is in the expanded state, the distal end of the frame faces proximally.

[0412] Example 35. The system according to any one of examples 31-34, wherein: while the docking station is in the compressed state, the shape-memory frame has a tubular shape extending, along a longitudinal axis, from a proximal end to a distal end, and while the docking station is in the expanded state, a portion of the frame defines a toroidal space, circumscribing the longitudinal axis of the frame.

[0413] Example 36. The system according to any one of examples 1-35, further comprising a plurality of restraining elements, each restraining element inhibiting expansion of an upstream portion of the dock, wherein the delivery tool is configured to secure the docking station in the atrium by: transluminally advancing the docking station to the atrium, and while the restraining elements inhibit expansion of the upstream portion of the dock, positioning the docking station such that: the downstream portion of the dock is open toward the inlet of the native valve, and adjusting each of the restraining elements such that the docking station further expands radially, thereby pressing the skirt against tissue of the atrium, and subsequently, securing the docking station in the atrium by adhering the skirt to the tissue by, via the nozzle, dispensing the adhesive between the skirt and the tissue.Attorney Docket No: TMTTMT- 24122WO01

[0414] Example 37. The system according to example 36, wherein the delivery tool is configured to secure the docking station in the atrium by adhering the skirt to the tissue by, via the nozzle, dispensing the adhesive between the skirt and the tissue, prior to releasing the restraining elements from the docking station.

[0415] Example 38. The system according to any one of examples 36-37, wherein the delivery tool is configured to secure the docking station in the atrium by adhering the skirt to the tissue by, via the nozzle, dispensing the adhesive between the skirt and the tissue, subsequently to releasing the restraining elements from the docking station.

[0416] Example 39. The system according to any one of examples 36-38, wherein the restraining elements are nonmetallic.

[0417] Example 40. The system according to any one of examples 36-39, wherein the restraining elements are more flexible than the dock.

[0418] Example 41. The system according to any one of examples 36-40, wherein the delivery tool: comprises the restraining elements, and is configured to be withdrawn from the subject, leaving the docking station secured in the atrium.

[0419] Example 42. The system according to example 41, wherein the delivery tool is configured to: release the restraining elements from the docking station, and subsequently, seat the prosthetic valve within the dock such that the prosthetic valve facilitates monodirectional flow of blood through the native valve.

[0420] Example 43. The system according to any one of examples 36-42, wherein: the docking station comprises the restraining elements, and the delivery tool is configured to be withdrawn from the subject, leaving the docking station secured in the atrium.

[0421] Example 44. The system according to example 43, wherein the restraining elements are reversibly coupled to a nonmetallic portion of the docking station.

[0422] Example 45. A system, for use with a subject, the system comprising: an implant comprising a self-expanding frame that defines a lumen of the implant, the frame having a plurality of eyelets distributed circumferentially around a perimeter of an end of the lumen, the implant having: a compressed state in which the implant is advanceable into the subject, and an expanded state in which the implant is configured to function within the subject, and in which the lumen is wider than in the compressed state; a cord, threaded through consecutive eyelets of the plurality in an arc around the perimeter; and a delivery tool, configured to: advance, intoAttorney Docket No: TMTTMT- 24122WO01the subject, the implant in its compressed state, and within the subject, control expansion of the implant toward the expanded state by controlling tension on the cord.

[0423] Example 46. The system according to example 45, wherein the implant, the cord and the delivery tool are sterile.

[0424] Example 47. The system according to any one of examples 45-46, wherein the delivery tool is reversibly coupled to the implant via the cord, and the delivery tool is configured to disengage from the cord and to withdraw from the subject, leaving the cord and the implant within the subject.

[0425] Example 48. The system according to any one of examples 45-47, wherein the delivery tool is reversibly coupled to the implant via the cord, and the delivery tool is configured to: release the implant by unthreading the cord from the eyelets, and withdraw from the subject, leaving the implant within the subject.

[0426] Example 49. The system according to any one of examples 45-48, wherein the delivery tool is configured to facilitate expansion of the implant toward the expanded state by reducing tension on the cord.

[0427] Example 50. The system according to example 49, wherein: the cord is a first cord, threaded through consecutive eyelets of the plurality in a first arc around the perimeter, such that reducing tension on the first cord facilitates expansion of a first sector of the perimeter, and the system further comprises a second cord, threaded through consecutive eyelets of the plurality in a second arc around the perimeter, such that reducing tension on the second cord facilitates expansion of a second sector of the perimeter.

[0428] Example 51. The system according to any one of examples 45-50, wherein the delivery tool: comprises an applicator that contains an adhesive; and is configured to secure the implant to tissue of the subject by adhering the implant to the tissue.

[0429] Example 52. The system according to example 51, wherein the delivery tool is configured to withdraw the applicator from the implant, leaving the implant secured to the tissue.

[0430] Example 53. The system according to any one of examples 51-52, wherein: the implant comprises a skirt circumscribing the implant; the applicator comprises a nozzle that provides fluid communication between the applicator and the skirt; and the delivery tool isAttorney Docket No: TMTTMT- 24122WO01configured to secure the implant to the tissue by adhering the skirt to the tissue by, via the nozzle, dispensing the adhesive between the skirt and the tissue.

[0431] Example 54. The system according to example 53, wherein the applicator is configured to dispense the adhesive via the nozzle, on a radial portion of the skirt, between the skirt and the tissue.

[0432] Example 55. The system according to any one of examples 53-54, wherein the skirt is configured to isolate the adhesive between the skirt and the tissue.

[0433] Example 56. The system according to example 55, wherein the implant is configured to define an adhesive receptacle between the skirt and the tissue.

[0434] Example 57. The system according to example 56, wherein the nozzle provides fluid communication between the applicator and the adhesive receptacle.

[0435] Example 58. The system according to any one of examples 56-57, wherein the adhesive receptacle circumscribes the implant.

[0436] Example 59. The system according to any one of examples 56-58, wherein the implant comprises a pair of cushions, each cushion disposed on the skirt such that the pair of cushions and the skirt define the adhesive receptacle.

[0437] Example 60. The system according to any one of examples 53-59, further comprising a curing sleeve: transluminally advanceable via the delivery tool, and configured to, after the adhesive is dispensed between the skirt and the tissue, cure the adhesive.

[0438] Example 61. The system according to example 60, wherein the curing sleeve is configured to cure the adhesive by providing a curing reagent to the adhesive.

[0439] Example 62. The system according to any one of examples 60-61, wherein the curing sleeve is configured to cure the adhesive by providing a curing energy to the adhesive.

[0440] Example 63. The system according to any one of examples 53-62, wherein the implant further comprises a permeable material disposed over the skirt to define a pocket between the skirt and the material, the nozzle opening into the pocket, and the delivery tool configured to dispense the adhesive, via the nozzle, between the skirt and the tissue by dispensing the adhesive into the pocket such that some of the adhesive permeates the material and contacts the tissue.Attorney Docket No: TMTTMT- 24122WO01

[0441] Example 64. The system according to example 63, wherein the material has a greater porosity than the skirt.

[0442] Example 65. The system according to any one of examples 63-64, wherein the material is more hydrophilic than the skirt.

[0443] Example 66. The system according to any one of examples 63-65, wherein the pocket circumscribes the skirt.

[0444] Example 67. The system according to example 66, wherein the pocket is shaped to define a ring-shaped sleeve disposed on a radial portion of the skirt.

[0445] Example 68. A system for use at a heart of a subject, the system comprising: an implant comprising a self-expanding frame that defines a lumen of the implant, the frame having a plurality of eyelets distributed circumferentially around a perimeter of an end of the lumen, the implant having: a compressed state in which the implant is transluminally advanceable to the heart, and an expanded state in which the implant is configured for blood flow through the lumen, and in which the lumen is wider than in the compressed state; and a delivery tool: comprising: a catheter, an extracorporeal controller at a proximal end of the catheter, and at least three cords, each cord: extending, from the controller, through the catheter to the implant, and threaded through consecutive eyelets of the plurality in an arc around the perimeter, each arc defining a corresponding sector of the end of the lumen, and configured to transluminally advance, to the heart, the implant in its compressed state within the catheter, and operatively coupled to the cords such that, via control of tension on each of the cords independently of each other, each of the sectors is controllably expandable independently of the other sectors.

[0446] Example 69. The system according to example 68, wherein the implant and the delivery tool are sterile.

[0447] Example 70. The system according to any one of examples 68-69, wherein the implant comprises a self-expanding docking station, the docking station: is configured to, while in the expanded state, to press circumferentially against a wall of an atrium of the heart, and comprises a dock, defining the lumen, that is configured to receive a prosthetic valve therewithin.

[0448] Example 71. The system according to any one of examples 68-70, wherein the delivery tool is configured to: release the implant within the heart by unthreading each cord from the respective consecutive eyelets, and withdraw from the heart.Attorney Docket No: TMTTMT- 24122WO01

[0449] Example 72. The system according to any one of examples 68-71, wherein the implant comprises a self-expanding prosthetic valve.

[0450] Example 73. The system according to example 72, wherein the prosthetic valve: comprises prosthetic leaflets, and is configured to be implanted within an atrium of the heart such that the prosthetic leaflets are disposed within the atrium, upstream of a native valve of the heart.

[0451] Example 74. The system according to any one of examples 68-73, wherein the delivery tool: comprises an applicator that contains an adhesive; and is configured to secure the implant to tissue of the heart by adhering the implant to the tissue.

[0452] Example 75. The system according to example 74, wherein the delivery tool is configured to withdraw the applicator from the implant, leaving the implant secured to the tissue.

[0453] Example 76. The system according to any one of examples 74-75, wherein: the implant comprises a skirt circumscribing the implant; the applicator comprises a nozzle that provides fluid communication between the applicator and the skirt; and the delivery tool is configured to secure the implant to the tissue by adhering the skirt to the tissue by, via the nozzle, dispensing the adhesive between the skirt and the tissue.

[0454] Example 77. The system according to example 76, wherein the applicator is configured to dispense the adhesive via the nozzle, on a radial portion of the skirt, between the skirt and the tissue.

[0455] Example 78. The system according to any one of examples 76-77, wherein the skirt is configured to isolate the adhesive between the skirt and the tissue.

[0456] Example 79. The system according to example 78, wherein the implant is configured to define an adhesive receptacle between the skirt and the tissue.

[0457] Example 80. The system according to example 79, wherein the nozzle provides fluid communication between the applicator and the adhesive receptacle.

[0458] Example 81. The system according to any one of examples 79-80, wherein the adhesive receptacle circumscribes the implant.

[0459] Example 82. The system according to any one of examples 79-81 , wherein the implant comprises a pair of cushions, each cushion disposed on the skirt such that the pair of cushions and the skirt define the adhesive receptacle.Attorney Docket No: TMTTMT- 24122WO01

[0460] Example 83. The system according to any one of examples 76-82, further comprising a curing sleeve: transluminally advanceable via the delivery tool, and configured to, after the adhesive is dispensed between the skirt and the tissue, cure the adhesive.

[0461] Example 84. The system according to example 83, wherein the curing sleeve is configured to cure the adhesive by providing a curing reagent to the adhesive.

[0462] Example 85. The system according to any one of examples 83-84, wherein the curing sleeve is configured to cure the adhesive by providing a curing energy to the adhesive.

[0463] Example 86. The system according to any one of examples 76-85, wherein the implant further comprises a permeable material disposed over the skirt to define a pocket between the skirt and the material, the nozzle opening into the pocket, and the delivery tool configured to dispense the adhesive, via the nozzle, between the skirt and the tissue by dispensing the adhesive into the pocket such that some of the adhesive permeates the material and contacts the tissue.

[0464] Example 87. The system according to example 86, wherein the material has a greater porosity than the skirt.

[0465] Example 88. The system according to any one of examples 86-87, wherein the material is more hydrophilic than the skirt.

[0466] Example 89. The system according to any one of examples 86-88, wherein the pocket circumscribes the skirt.

[0467] Example 90. The system according to example 89, wherein the pocket is shaped to define a ring-shaped sleeve disposed on a radial portion of the skirt.

[0468] Example 91. A system for use at a heart of a subject, the heart having an atrium, the system comprising: an implant comprising a self-expanding frame that defines a lumen of the implant, the implant having: a compressed state in which the implant is transluminally advanceable to the atrium, an expanded state in which the implant is configured to press circumferentially against a wall of the atrium, a cord, coupled to at least three points along a perimeter of an end of the lumen; and a delivery tool, reversibly coupled to the implant via the cord, the delivery tool defining a distal portion reversibly coupled to the cord, the delivery tool configured to: transluminally advance, into the atrium, the implant in its compressed state, within the atrium, control expansion of the implant toward the expanded state by controlling tension on the cord.Attorney Docket No: TMTTMT- 24122WO01

[0469] Example 92. The system according to example 91, wherein the implant and the delivery tool are sterile.

[0470] Example 93. The system according to any one of examples 91-92, wherein the delivery tool is configured to: reduce tension on the cord, thereby allowing the implant to radially expand against a wall of the atrium, secure the implant to the wall of the atrium, and withdraw from the heart.

[0471] Example 94. The system according to any one of examples 91-93, wherein the delivery tool: comprises an applicator that contains an adhesive; and is configured to secure the implant to tissue of the heart by adhering the implant to the tissue.

[0472] Example 95. The system according to example 94, wherein the delivery tool is configured to withdraw the applicator from the implant, leaving the implant secured to the tissue.

[0473] Example 96. The system according to any one of examples 94-95, wherein: the implant comprises a skirt circumscribing the implant; the applicator comprises a nozzle that provides fluid communication between the applicator and the skirt; and the delivery tool is configured to secure the implant to the tissue by adhering the skirt to the tissue by, via the nozzle, dispensing the adhesive between the skirt and the tissue.

[0474] Example 97. The system according to example 96, wherein the applicator is configured to dispense the adhesive via the nozzle, on a radial portion of the skirt, between the skirt and the tissue.

[0475] Example 98. The system according to any one of examples 96-97, wherein the skirt is configured to isolate the adhesive between the skirt and the tissue.

[0476] Example 99. The system according to example 98, wherein the implant is configured to define an adhesive receptacle between the skirt and the tissue.

[0477] Example 100. The system according to example 99, wherein the nozzle provides fluid communication between the applicator and the adhesive receptacle.

[0478] Example 101. The system according to any one of examples 99-100, wherein the adhesive receptacle circumscribes the implant.

[0479] Example 102. The system according to any one of examples 99-101, wherein the implant comprises a pair of cushions, each cushion disposed on the skirt such that the pair of cushions and the skirt define the adhesive receptacle.Attorney Docket No: TMTTMT- 24122WO01

[0480] Example 103. The system according to any one of examples 96-102, further comprising a curing sleeve: transluminally advanceable via the delivery tool, and configured to, after the adhesive is dispensed between the skirt and the tissue, cure the adhesive.

[0481] Example 104. The system according to example 103, wherein the curing sleeve is configured to cure the adhesive by providing a curing reagent to the adhesive.

[0482] Example 105. The system according to any one of examples 103-104, wherein the curing sleeve is configured to cure the adhesive by providing a curing energy to the adhesive.

[0483] Example 106. The system according to any one of examples 96-105, wherein the implant further comprises a permeable material disposed over the skirt to define a pocket between the skirt and the material, the nozzle opening into the pocket, and the delivery tool configured to dispense the adhesive, via the nozzle, between the skirt and the tissue by dispensing the adhesive into the pocket such that some of the adhesive permeates the material and contacts the tissue.

[0484] Example 107. The system according to example 106, wherein the material has a greater porosity than the skirt.

[0485] Example 108. The system according to any one of examples 106-107, wherein the material is more hydrophilic than the skirt.

[0486] Example 109. The system according to any one of examples 106-108, wherein the pocket circumscribes the skirt.

[0487] Example 110. The system according to example 109, wherein the pocket is shaped to define a ring-shaped sleeve disposed on a radial portion of the skirt.

[0488] Example 111. A system for use with a prosthetic valve at a heart of a subject, the heart having a native valve disposed between an atrium of the heart and a ventricle of the heart, the system comprising: a self-expanding docking station, having a compressed state in which the docking station is transluminally advanceable to the atrium, and an expanded state in which the docking station is configured to press circumferentially against a wall of the atrium, the docking station comprising a dock that is configured to receive a prosthetic valve therewithin; a cord, coupled to at least three points along a perimeter of an upstream portion of the dock; and a delivery tool, configured to: transluminally advance the docking station to the atrium, deploy the docking station, via the cord, from the tool into the atrium, such that the docking station presses circumferentially against the wall of the atrium around an inlet of the native valve, suchAttorney Docket No: TMTTMT- 24122WO01that a downstream portion of the dock is open toward the inlet of the native valve, and secure the docking station to the wall of the atrium.

[0489] Example 112. The system according to example 111, wherein the docking station, the cord and the delivery tool are sterile.

[0490] Example 113. The system according to any one of examples 111-112, wherein the delivery tool is reversibly coupled to the docking station, via the cord, and the delivery tool is configured to disengage from the cord and to withdraw from the heart, leaving the cord and the docking station secured to the wall of the atrium.

[0491] Example 114. The system according to any one of examples 111-113, wherein the delivery tool is reversibly coupled to the docking station, via the cord, and the delivery tool is configured to: release the docking station by decoupling the cord from the docking station, and withdraw from the heart, leaving the docking station secured to the wall of the atrium.

[0492] Example 115. The system according to any one of examples 111-114, wherein the system further comprises the prosthetic valve, configured to be seated within the dock.

[0493] Example 116. The system according to any one of examples 111-115, wherein the delivery tool is configured to, after deploying the docking station into the atrium, adjust tension on the upstream portion of the dock, via the cord, such that the docking station expands circumferentially against the wall of the atrium.

[0494] Example 117. The system according to example 116, wherein the delivery tool is configured to, after deploying the docking station into the atrium, reduce tension on the cord such that the docking station expands circumferentially against the wall of the atrium.

[0495] Example 118. The system according to example 117, wherein: the cord is a first cord, coupled to a first portion of the perimeter of the upstream portion of the dock, such that reducing tension on the first cord facilitates expansion of the first portion of the perimeter of the upstream portion of the dock, and the system further comprises a second cord, coupled to a second portion of the perimeter of the upstream portion of the dock, such that reducing tension on the second cord facilitates expansion of the second portion of the perimeter of the upstream portion of the dock.

[0496] Example 119. The system according to any one of examples 111-118, wherein the delivery tool: comprises an applicator that contains an adhesive; and is configured to secure theAttorney Docket No: TMTTMT- 24122WO01docking station to the wall of the atrium by adhering the docking station to the wall of the atrium.

[0497] Example 120. The system according to example 119, wherein the delivery tool is configured to withdraw the applicator from the docking station, leaving the docking station secured to the wall of the atrium.

[0498] Example 121. The system according to any one of examples 119-120, wherein: the docking station comprises a skirt circumscribing the docking station; the applicator comprises a nozzle that provides fluid communication between the applicator and the skirt; and the delivery tool is configured to secure the docking station to the wall of the atrium by adhering the skirt to the wall of the atrium by, via the nozzle, dispensing the adhesive between the skirt and the wall of the atrium.

[0499] Example 122. The system according to example 121, wherein the applicator is configured to dispense the adhesive via the nozzle, on a radial portion of the skirt, between the skirt and the wall of the atrium.

[0500] Example 123. The system according to any one of examples 121-122, wherein the skirt is configured to isolate the adhesive between the skirt and the wall of the atrium.

[0501] Example 124. The system according to any one of examples 121-123, wherein the docking station is configured to define an adhesive receptacle between the skirt and the wall of the atrium.

[0502] Example 125. The system according to example 124, wherein the nozzle provides fluid communication between the applicator and the adhesive receptacle.

[0503] Example 126. The system according to any one of examples 124-125, wherein the adhesive receptacle circumscribes the docking station.

[0504] Example 127. The system according to any one of examples 124-126, wherein the docking station comprises a pair of cushions, each cushion disposed on the skirt such that the pair of cushions and the skirt define the adhesive receptacle.

[0505] Example 128. The system according to any one of examples 121-127, further comprising a curing sleeve: transluminally advanceable via the delivery tool, and configured to, after the adhesive is dispensed between the skirt and the wall of the atrium, cure the adhesive.

[0506] Example 129. The system according to example 128, wherein the curing sleeve is configured to cure the adhesive by providing a curing reagent to the adhesive.Attorney Docket No: TMTTMT- 24122WO01

[0507] Example 130. The system according to any one of examples 128-129, wherein the curing sleeve is configured to cure the adhesive by providing a curing energy to the adhesive.

[0508] Example 131. The system according to any one of examples 121-130, wherein the docking station further comprises a permeable material disposed over the skirt to define a pocket between the skirt and the material, the nozzle opening into the pocket, and the delivery tool configured to dispense the adhesive, via the nozzle, between the skirt and the wall of the atrium by dispensing the adhesive into the pocket such that some of the adhesive permeates the material and contacts the wall of the atrium.

[0509] Example 132. The system according to example 131, wherein the material has a greater porosity than the skirt.

[0510] Example 133. The system according to any one of examples 131-132, wherein the material is more hydrophilic than the skirt.

[0511] Example 134. The system according to any one of examples 131-133, wherein the pocket circumscribes the skirt.

[0512] Example 135. The system according to example 134, wherein the pocket is shaped to define a ring-shaped sleeve disposed on a radial portion of the skirt.

[0513] Example 136. A system for use at a heart of a subject, the heart having a native valve disposed between an atrium of the heart and a ventricle of the heart, the system comprising: an expandable prosthetic valve, comprising a skirt circumscribing a downstream portion of the prosthetic valve; and a delivery tool: comprising an applicator that contains an adhesive and comprises a nozzle that provides fluid communication between the applicator and the skirt, and configured to secure the prosthetic valve in the atrium by: transluminally advancing the prosthetic valve to the atrium, pressing the skirt against tissue of the atrium around an inlet of the native valve such that the downstream portion of the prosthetic valve is open toward the inlet of the native valve, and adhering the skirt to the tissue by, via the nozzle, dispensing the adhesive between the skirt and the tissue.

[0514] Example 137. The system according to example 136, wherein the prosthetic valve and the delivery tool are sterile.

[0515] Example 138. The system according to any one of examples 136-137, wherein the applicator is configured to dispense the adhesive via the nozzle, on a radial portion of the skirt, between the skirt and the tissue.Attorney Docket No: TMTTMT- 24122WO01

[0516] Example 139. The system according to any one of examples 136-138, wherein the skirt is configured to isolate the adhesive between the skirt and the tissue.

[0517] Example 140. The system according to example 139, wherein the prosthetic valve is configured to define an adhesive receptacle between the skirt and the tissue.

[0518] Example 141. The system according to example 140, wherein the nozzle provides fluid communication between the applicator and the adhesive receptacle.

[0519] Example 142. The system according to any one of examples 140-141, wherein the adhesive receptacle circumscribes the prosthetic valve.

[0520] Example 143. The system according to any one of examples 140-142, wherein the prosthetic valve comprises a pair of cushions, each cushion disposed on the skirt such that the pair of cushions and the skirt define the adhesive receptacle.

[0521] Example 144. The system according to any one of examples 140-143, further comprising a curing sleeve: transluminally advanceable via the delivery tool, and configured to, after the adhesive is dispensed between the skirt and the tissue, cure the adhesive.

[0522] Example 145. The system according to example 144, wherein the curing sleeve is configured to cure the adhesive by providing a curing reagent to the adhesive.

[0523] Example 146. The system according to any one of examples 144-145, wherein the curing sleeve is configured to cure the adhesive by providing a curing energy to the adhesive.

[0524] Example 147. The system according to any one of examples 140-146, wherein the prosthetic valve further comprises a permeable material disposed over the skirt to define a pocket between the skirt and the material, the nozzle opening into the pocket, and the delivery tool configured to dispense the adhesive, via the nozzle, between the skirt and the tissue by dispensing the adhesive into the pocket such that some of the adhesive permeates the material and contacts the tissue.

[0525] Example 148. The system according to example 147, wherein the material has a greater porosity than the skirt.

[0526] Example 149. The system according to any one of examples 147-148, wherein the material is more hydrophilic than the skirt.

[0527] Example 150. The system according to any one of examples 147-149, wherein the pocket circumscribes the skirt.Attorney Docket No: TMTTMT- 24122WO01

[0528] Example 151. The system according to example 150, wherein the pocket is shaped to define a ring-shaped sleeve disposed on a radial portion of the skirt.

[0529] Example 152. A method for use at a simulated heart of a subject, the simulated heart having a native valve disposed between an atrium of the simulated heart and a ventricle of the simulated heart, the method comprising: transluminally advancing, via a delivery tool, a compressed docking station to the atrium, the docking station: defining a dock configured to receive a prosthetic valve therewithin, and including a skirt circumscribing a downstream portion of the dock; deploying the docking station from the delivery tool such that the docking station expands radially into a position within the atrium, thereby pressing the skirt against a wall of the atrium around an inlet of the native valve such that: the downstream portion of the dock is open toward an inlet of the native valve, and the dock is disposed upstream of the native valve; transluminally advancing an applicator via the delivery tool such that a distal nozzle of the applicator provides fluid communication between the applicator and the skirt; while using the delivery tool to hold the docking station in the position, securing the docking station in the atrium by adhering the skirt to tissue of the atrium by, via the nozzle, dispensing the adhesive between the skirt and the tissue; and seating a prosthetic valve, comprising a plurality of prosthetic leaflets, within the dock such that the prosthetic leaflets facilitate monodirectional flow of blood through the native valve.

[0530] Example 153. A method for use at a heart of a subject, the heart having a native valve disposed between an atrium of the heart and a ventricle of the heart, the method comprising: transluminally advancing, via a delivery tool, a compressed docking station to the atrium, the docking station: defining a dock configured to receive a prosthetic valve therewithin, and including a skirt circumscribing a downstream portion of the dock; deploying the docking station from the delivery tool such that the docking station expands radially into a position within the atrium, thereby pressing the skirt against a wall of the atrium around an inlet of the native valve such that: the downstream portion of the dock is open toward an inlet of the native valve, and the dock is disposed upstream of the native valve; transluminally advancing an applicator via the delivery tool such that a distal nozzle of the applicator provides fluid communication between the applicator and the skirt; while using the delivery tool to hold the docking station in the position, securing the docking station in the atrium by adhering the skirt to tissue of the atrium by, via the nozzle, dispensing the adhesive between the skirt and the tissue; and seating a prosthetic valve, comprising a plurality of prosthetic leaflets, within theAttorney Docket No: TMTTMT- 24122WO01dock such that the prosthetic leaflets facilitate monodirectional flow of blood through the native valve.

[0531] Example 154. The method according to example 153, further comprising sterilizing the delivery tool, the docking station and the prosthetic valve.

[0532] Example 155. The method according to any one of examples 153-154, further comprising, subsequently to the step of securing, withdrawing the applicator from between the applicator and the skirt, thereby leaving the docking station secured in the atrium.

[0533] Example 156. The method according to any one of examples 153-155, wherein seating comprises seating the prosthetic valve within the dock such that the prosthetic leaflets remain within the atrium as the native valve reciprocatingly transitions between ventricular systole and ventricular diastole.

[0534] Example 157. The method according to any one of examples 153-156, wherein seating comprises 2-10 weeks subsequently to adhering the skirt to the tissue, seating the prosthetic valve within the dock such that the prosthetic leaflets facilitate monodirectional flow of blood through the native valve.

[0535] Example 158. The method according to any one of examples 153-157, wherein dispensing the adhesive between the skirt and the tissue comprises dispensing the adhesive into a toroidal space between the skirt and the tissue.

[0536] Example 159. The method according to any one of examples 153-158, wherein dispensing the adhesive between the skirt and the tissue comprises electrically insulating the docking station from the tissue.

[0537] Example 160. The method according to any one of examples 153-159, wherein: the skirt includes a permeable material disposed over the skirt to define a pocket between the skirt and the material, the nozzle opens into the pocket, and dispensing the adhesive comprises dispensing the adhesive, via the nozzle, into the pocket such that some of the adhesive permeates the material and contacts the tissue.

[0538] Example 161. The method according to any one of examples 153-160, wherein: wherein the docking station includes a pair of cushions comprising an upstream cushion and a downstream cushion, and dispensing the adhesive between the skirt and the tissue comprises dispensing the adhesive into a space circumscribed by the skirt, the pair of cushions, and the tissue.Attorney Docket No: TMTTMT- 24122WO01

[0539] Example 162. The method according to any one of examples 153-161, further comprising, subsequently to dispensing the adhesive between the skirt and the tissue curing the adhesive by transluminally advancing a curing agent, via the delivery tool, to between the skirt and the tissue.

[0540] Example 163. The method according to example 162, wherein seating the prosthetic valve comprises, subsequently to curing the adhesive, seating the prosthetic valve within the dock such that the prosthetic leaflets facilitate monodirectional flow of blood through the native valve.

[0541] Example 164. The method according to any one of examples 162-163, wherein curing the adhesive comprises transluminally advancing a curing reagent, via the delivery tool, to between the skirt and the tissue.

[0542] Example 165. The method according to any one of examples 162-164, wherein curing the adhesive comprises transluminally advancing a curing energy, via the delivery tool, to between the skirt and the tissue.

[0543] Example 166. A method for use at a simulated heart of a subject, the simulated heart having a native valve disposed between an atrium of the simulated heart and a ventricle of the simulated heart, the method comprising: transluminally advancing, via a delivery tool, a compressed docking station to the atrium, the docking station: defining a dock configured to receive a prosthetic valve therewithin, and including a skirt circumscribing a downstream portion of the dock; deploying the docking station from the delivery tool, while restraining an upstream opening of the dock from fully radially expanding, into the atrium, such that: the dock is disposed upstream of the native valve, and a downstream opening of the dock faces an inlet of the native valve; and subsequently: allowing the docking station to further radially expand, such that expansion of the docking station presses the skirt against a wall of the atrium, and securing the skirt to the wall of the atrium.

[0544] Example 167. A method for use at a heart of a subject, the heart having a native valve disposed between an atrium of the heart and a ventricle of the heart, the method comprising: transluminally advancing, via a delivery tool, a compressed docking station to the atrium, the docking station: defining a dock configured to receive a prosthetic valve therewithin, and including a skirt circumscribing a downstream portion of the dock; deploying the docking station from the delivery tool, while restraining an upstream opening of the dock from fully radially expanding, into the atrium, such that: the dock is disposed upstream of the native valve,Attorney Docket No: TMTTMT- 24122WO01and a downstream opening of the dock faces an inlet of the native valve; and subsequently: allowing the docking station to further radially expand, such that expansion of the docking station presses the skirt against a wall of the atrium, and securing the skirt to the wall of the atrium.

[0545] Example 168. The method according to example 167, further comprising sterilizing the delivery tool and the docking station.

[0546] Example 169. The method according to any one of examples 167-168, further comprising seating a prosthetic valve within the dock such that prosthetic leaflets of the prosthetic valve are disposed within the atrium, upstream of the native valve.

[0547] Example 170. The method according to any one of examples 167-169, wherein: restraining comprises restraining the upstream opening of the dock from fully radially expanding by, using the delivery tool, maintaining tension upon a restraining element coupled to the upstream opening of the dock; and allowing the docking station to further radially expand comprises decoupling the restraining element from the dock.

[0548] Example 171. The method according to example 170, further comprising, using the delivery tool, removing the restraining element from the subject.

[0549] Example 172. The method according to any one of examples 170-171, wherein: the restraining element is coupled to the upstream opening of the dock via a cord that is threaded through the upstream opening of the dock, and decoupling the restraining element from the dock comprises decoupling the restraining element from the cord.

[0550] Example 173. The method according to any one of examples 170-172, wherein: the restraining element is a first restraining element, coupled to a first portion of the upstream opening of the dock; maintaining tension comprises maintaining tension upon: the first restraining element coupled to the first portion of the upstream opening of the dock, and a second restraining element coupled to a second portion of the upstream opening of the dock; and allowing the docking station to further radially expand comprises decoupling: the first restraining element from the first portion of the upstream opening of the dock, and the second restraining element from the first portion of the upstream opening of the dock.

[0551] Example 174. The method according to example 173, wherein: the first and second restraining elements each include a first and second cord, each cord threaded through eyelets of a respective portion of the upstream opening of the dock; and decoupling comprises:Attorney Docket No: TMTTMT- 24122WO01unthreading each cord from the eyelets of the respective portion of the upstream opening of the dock.

[0552] Example 175. A method for use at a simulated heart of a subject, the method comprising: transluminally advancing, using a delivery tool, a compressed implant to the heart; deploying the implant from the delivery tool, (i) via a cord that is threaded through an upstream portion of the implant, and (ii) while the cord restrains the upstream portion of the implant from fully radially expanding, into a position within the heart; while holding the implant in the position: adjusting tension on the cord to allow the implant to further radially expand, thereby pressing the implant against tissue of the heart, and securing the implant to the heart; and subsequently, withdrawing the delivery tool from the heart.

[0553] Example 176. A method for use at a heart of a subject, the method comprising: transluminally advancing, using a delivery tool, a compressed implant to the heart; deploying the implant from the delivery tool, (i) via a cord that is threaded through an upstream portion of the implant, and (ii) while the cord restrains the upstream portion of the implant from fully radially expanding, into a position within the heart; while holding the implant in the position: adjusting tension on the cord to allow the implant to further radially expand, thereby pressing the implant against tissue of the heart, and securing the implant to the heart; and subsequently, withdrawing the delivery tool from the heart.

[0554] Example 177. The method according to example 176, further comprising sterilizing the delivery tool and the implant.

[0555] Example 178. The method according to example 176, further comprising, prior to the step of withdrawing, releasing the cord from the delivery tool, such that withdrawing the delivery tool from the heart comprises leaving the cord and the implant within the heart.

[0556] Example 179. The method according to any one of examples 176-178, wherein: adjusting tension comprises reducing tension on the cord to allow the implant to further radially expand, thereby pressing the implant against tissue of the heart.

[0557] Example 180. The method according to any one of examples 176-179, wherein: deploying comprises deploying the implant from the delivery tool via a plurality of distal arms of the delivery tool that are coupled to the cord; and reducing tension on the cord comprises reducing tension on the cord by pivoting the distal arms radially apart.Attorney Docket No: TMTTMT- 24122WO01

[0558] Example 181. The method according to any one of examples 176-180, further comprising, prior to withdrawing the delivery tool from the heart, releasing the implant within the heart by unthreading the cord from the upstream portion of the implant.

[0559] Example 182. The method according to any one of examples 176-181, wherein: the cord includes: a first cord, threaded through the upstream portion of the implant along a first arc around a perimeter of the upstream portion, and a second cord, threaded through the upstream portion of the implant along a second arc around the perimeter of the upstream portion; and adjusting tension comprises adjusting tension on the first cord and the second cord.

[0560] Example 183. The method according to example 182, wherein adjusting tension comprises adjusting tension of the first cord and the second cord, independently of each other.

[0561] Example 184. The method according to any one of examples 182-183, further comprising, prior to withdrawing the delivery tool from the heart, releasing the implant within the heart by unthreading each cord from the upstream portion of the implant.

[0562] Example 185. A system for use in a heart of a subject, the system comprising: a docking station configured to receive a prosthetic valve therewithin; and a delivery tool comprising an applicator that contains an adhesive, wherein the delivery tool is configured to secure the docking station at or near an upstream side of a native heart valve of a heart by: transluminally advancing the docking station to the native heart valve such that the docking station is in contact with tissue at or near an inlet of the native heart valve such that a downstream portion of the docking station can open toward the inlet of the native heart valve, and adhering the docking station to the tissue by dispensing the adhesive from the applicator, such that the adhesive contacts both the docking station and the tissue.

[0563] Example 186. The system according to example 185, wherein the docking station and the delivery tool are sterile.

[0564] Example 187. The system according to any one of examples 185-186, wherein the docking station comprises a skirt at a downstream portion of the docking station, and wherein the applicator is configured to dispense the adhesive at a radial portion of the skirt, between the skirt and the tissue.

[0565] Example 188. The system according to any one of examples 185-187, wherein the delivery tool is configured to withdraw the applicator from the docking station, leaving the docking station secured to the tissue.Attorney Docket No: TMTTMT- 24122WO01

[0566] Example 189. The system according to any one of examples 185-188, wherein: the docking station comprises a frame that defines a plurality of eyelets around a perimeter of the dock; and the system comprises a flexible material, threaded through at least some eyelets of the plurality of eyelets.

[0567] Example 190. The system according to example 189, wherein the delivery tool: comprises a catheter; and is configured to deploy the docking station from the catheter and into a heart using the flexible material.

[0568] Example 191. The system according to any one of examples 189-190, wherein: the frame is a self-expanding frame; and the delivery tool is configured to control expansion of the frame by controlling tension on the flexible material.

[0569] Example 192. The system according to example 191, wherein the delivery tool is reversibly coupled to the docking station via the flexible material, and the delivery tool is configured to disengage from the flexible material and to withdraw from the subject, leaving the flexible material and the docking station within the subject.

[0570] Example 193. The system according to example 191, wherein the delivery tool is reversibly coupled to the docking station via the flexible material, and the delivery tool is configured to: release the docking station by unthreading the flexible material from the eyelets, and withdraw from the subject, leaving the docking station within the subject.

[0571] Example 194. The system according to any one of examples 191-193, wherein the delivery tool is configured to facilitate expansion of the frame by reducing tension on the flexible material.

[0572] Example 195. The system according to example 194, wherein: the flexible material is a first cord, threaded through at least some eyelets of the plurality, such that reducing tension on the first cord facilitates expansion of a first sector of the perimeter, and the system further comprises a second cord, threaded through at least some eyelets of the plurality, such that reducing tension on the second cord facilitates expansion of a second sector of the perimeter.

[0573] Example 196. The system according to example 195, wherein the delivery tool is operatively coupled to the first and second cords such that, by reducing tension on each of the cords independently of each other, each of the sectors is controllably expandable independently of the other sector.Attorney Docket No: TMTTMT- 24122WO01

[0574] Example 197. The system according to any one of examples 195-196, wherein the delivery tool is configured to: release the docking station within the heart by unthreading each cord from respective eyelets, and withdraw from the heart.

[0575] Example 198. The system according to any one of examples 185-197, wherein the docking station is configured to define an adhesive receptacle.

[0576] Example 199. The system according to example 198, wherein the docking station comprises a pair of cushions comprising an upstream cushion and a downstream cushion, each cushion disposed on the docking station such that the pair of cushions define at least a portion of the adhesive receptacle.

[0577] Example 200. The system according to any one of examples 185-199, wherein the system further comprises the prosthetic valve, the prosthetic valve configured to be: transluminally advanceable, via the delivery tool, to or near the native heart valve, and seated within the docking station such that the prosthetic valve facilitates monodirectional flow of blood through the native heart valve.

[0578] Example 201. The system according to example 200, wherein the prosthetic valve comprises a plurality of prosthetic leaflets, configured to facilitate monodirectional flow of blood through the native valve, while remaining upstream of the native heart valve as the native heart valve reciprocatingly transitions between ventricular systole and ventricular diastole.

[0579] Example 202. The system according to any one of examples 185-201, further comprising a curing sleeve: transluminally advanceable via the delivery tool, and configured to, after the adhesive is dispensed in contact with the docking station and the tissue, cure the adhesive.

[0580] Example 203. The system according to example 202, wherein the curing sleeve is configured to cure the adhesive by providing a curing reagent to the adhesive.

[0581] Example 204. The system according to example 202, wherein the curing sleeve is configured to cure the adhesive by providing a curing energy to the adhesive.

[0582] Example 205. The system according to any one of examples 185-204, wherein the docking station comprises a skirt configured to inhibit flow of blood through the downstream portion of the docking station.Attorney Docket No: TMTTMT- 24122WO01

[0583] Example 206. The system according to example 205, wherein the docking station defines a central lumen, and the skirt is configured to inhibit flow of blood through the docking station, radially outside of the central lumen.

[0584] Example 207. The system according to any one of examples 185-206, wherein the docking station further comprises a permeable material that defines at least part of a pocket, wherein the delivery tool is configured to dispense the adhesive in contact with the docking station and the tissue by dispensing the adhesive into the pocket such that some of the adhesive permeates the material and contacts the tissue.

[0585] Example 208. The system according to example 207, wherein the pocket circumscribes the downstream portion of the docking station.

[0586] Example 209. The system according to example 208, wherein the pocket is shaped to define a ring-shaped sleeve disposed on a radial portion of the docking station.

[0587] Example 210. The system according to any one of examples 185-209, wherein: the delivery tool comprises a catheter, transluminally advanceable to the heart, and the docking station comprises a shape-memory frame, such that the docking station has: a compressed state in which the docking station is transluminally advanceable, via the catheter, to the heart, and an expanded state in which an external diameter of the docking station is greater than an internal diameter of an atrium upstream of the native heart valve, such that a radial portion of the docking station presses towards tissue of the heart at or near the native heart valve.

[0588] Example 211. The system according to example 210, wherein: while the docking station is in the compressed state, the shape-memory frame has a tubular shape extending along a longitudinal axis, and while the docking station is in the expanded state, a first portion of the frame extends along the longitudinal axis, and a second portion of the frame extends radially away from the longitudinal axis.

[0589] Example 212. The system according to example 210, wherein: while the docking station is in the compressed state, the shape-memory frame has a tubular shape defining a medially-facing tube -interior and a radially-facing tube-exterior, and while the docking station is in the expanded state, a portion of the tube -interior defines a radially-facing portion of the frame.

[0590] Example 213. The system according to example 210, wherein: while the docking station is in the compressed state, the shape-memory frame has a tubular shape extending, along a longitudinal axis, from a proximal end to a distal end, and while the docking station is in theAttorney Docket No: TMTTMT- 24122WO01expanded state, a portion of the frame defines a toroidal space, circumscribing the longitudinal axis of the frame.

[0591] Example 214. The system according to any one of examples 185-213, further comprising a plurality of restraining elements, each restraining element inhibiting expansion of an upstream portion of the docking station, wherein the delivery tool is configured to secure the docking station in the heart by: transluminally advancing the docking station to the heart, and while the restraining elements inhibit expansion of the upstream portion of the docking station, positioning the docking station such that: the downstream portion of the docking station is open toward the inlet of the native valve, and adjusting each of the restraining elements such that the docking station further expands radially, thereby pressing the docking station towards the tissue, and subsequently, securing the docking station in the heart by adhering the docking station to the tissue.

[0592] Example 215. The system according to example 214, wherein the delivery tool is configured to secure the docking station in the heart by adhering the docking station to the tissue by dispensing the adhesive in contact with the docking station and the tissue, prior to releasing the restraining elements from the docking station.

[0593] Example 216. The system according to example 214, wherein the delivery tool comprises the restraining elements, and is configured to be withdrawn from the subject, leaving the docking station secured in the heart.

[0594] Example 217. A system for use at a native valve of a heart of a subject, the system comprising: an expandable device, comprising a skirt circumscribing at least a portion of the device; and a delivery tool: having a distal portion to which the device is couplable, comprising an applicator that contains an adhesive and comprises a nozzle that provides fluid communication between the applicator and the skirt, and configured to secure the device to the native valve by: pressing the skirt against tissue of the native valve, and adhering the skirt to the tissue by, via the nozzle, dispensing the adhesive between the skirt and the tissue.

[0595] Example 218. The system according to example 217, wherein the device and the delivery tool are sterile.

[0596] Example 219. The system according to any one of examples 217-218, wherein the delivery tool is configured to secure the device to the native valve by pressing the skirt against tissue at an inlet of the native valve such that a downstream portion of the device is open toward the inlet of the native valve.Attorney Docket No: TMTTMT- 24122WO01

[0597] Example 220. The system according to any one of examples 217-219, wherein the device is shaped to have an upstream circumferential bulge at an upstream portion of the skirt and a downstream circumferential bulge at a downstream portion of the skirt.

[0598] Example 221. The system according to any one of examples 217-220, wherein the portion is a valve portion that comprises a stent and prosthetic leaflets mounted within the stent.

[0599] Example 222. The system according to any one of examples 217-221, wherein the applicator is configured to dispense the adhesive via the nozzle, on a radial portion of the skirt, between the skirt and the tissue.

[0600] Example 223. The system according to any one of examples 217-222, wherein the delivery tool is configured to withdraw the applicator from the device, leaving the device secured to the tissue.

[0601] Example 224. The system according to any one of examples 217-223, wherein the applicator is a first applicator, and wherein the delivery tool comprises multiple applicators including the first applicator, the multiple applicators diverging from each other at the distal portion such that the nozzles of the applicators are distributed circumferentially around the skirt.

[0602] Example 225. The system according to any one of examples 217-224, wherein the delivery tool comprises 2-12 applicators.

[0603] Example 226. The system according to example 225, wherein the delivery tool comprises 6-12 applicators.

[0604] Example 227. The system according to any one of examples 217-226, wherein the skirt circumscribes a downstream portion of the device.

[0605] Example 228. The system according to any one of examples 217-227, wherein the skirt is radially spaced from the portion.

[0606] Example 229. The system according to any one of examples 217-228, wherein the device comprises a frame having a radial portion that supports the skirt radially spaced from the portion.

[0607] Example 230. The system according to any one of examples 217-229, wherein the skirt is configured to isolate the adhesive between the skirt and the tissue.

[0608] Example 231. The system according to example 230, wherein the device is configured to define an adhesive receptacle between the skirt and the tissue.Attorney Docket No: TMTTMT- 24122WO01

[0609] Example 232. The system according to example 231, wherein the adhesive receptacle circumscribes the device.

[0610] Example 233. The system according to any one of examples 231-232, wherein the nozzle provides fluid communication between the applicator and the adhesive receptacle.

[0611] Example 234. The system according to example 233, wherein the nozzle is disposed at the adhesive receptacle.

[0612] Example 235. The system according to any one of examples 231-234, wherein the device is shaped to have an upstream circumferential bulge upstream of the receptacle and a downstream circumferential bulge downstream of the receptacle.

[0613] Example 236. The system according to any one of examples 231-235, wherein the device further comprises a permeable material disposed over the skirt, the permeable material configured to define at least a part of the adhesive receptacle between the skirt and the tissue.

[0614] Example 237. The system according to example 236, wherein the permeable material defines a circumferential boundary of the adhesive receptacle.

[0615] Example 238. The system according to any one of examples 236-237, wherein the permeable material defines a toroidal adhesive receptacle between the skirt and the tissue.

[0616] Example 239. The system according to any one of examples 236-238, wherein the permeable material has a greater absorbency than the skirt.

[0617] Example 240. The system according to any one of examples 236-239, wherein the material has a greater porosity than the skirt.

[0618] Example 241. The system according to any one of examples 236-240, wherein the material is more hydrophilic than the skirt.

[0619] Example 242. The system according to any one of examples 236-241, wherein the delivery tool is configured to dispense the adhesive, via the nozzle, between the skirt and the tissue such that some of the adhesive permeates the material and contacts the tissue.

[0620] Example 243. The system according to any one of examples 236-242, wherein the delivery tool is configured to dispense the adhesive, via the nozzle, to the permeable material such that some of the adhesive permeates the material and contacts the tissue.

[0621] Example 244. The system according to any one of examples 236-243, wherein the device comprises a pair of cushions, each cushion disposed on the skirt.Attorney Docket No: TMTTMT- 24122WO01

[0622] Example 245. The system according to example 244, wherein the permeable material is disposed over the skirt and each of the cushions, such that the permeable material defines at least a part of the adhesive receptacle between the cushions.

[0623] Example 246. The system according to example 245, wherein the delivery tool is configured to dispense the adhesive, via the nozzle, between the cushions and the tissue such that some of the adhesive permeates the material and contacts the tissue

[0624] Example 247. The system according to any one of examples 245-246, wherein the pair of cushions comprises an upstream cushion and a downstream cushion, such that the permeable material defines at least part of a circumferential adhesive receptacle between the cushions and the tissue.

[0625] Example 248. The system according to any one of examples 236-247, wherein: the adhesive receptacle defines a pocket between the skirt and the permeable material, the nozzle opening into the pocket, and the delivery tool is configured to dispense the adhesive, via the nozzle, between the skirt and the tissue by dispensing the adhesive into the pocket such that some of the adhesive permeates the material and contacts the tissue.

[0626] Example 249. The system according to example 248, wherein the pocket circumscribes the skirt.

[0627] Example 250. The system according to any one of examples 248-249, wherein the pocket is shaped to define a ring-shaped sleeve disposed on a radial portion of the skirt.

[0628] Example 251. The system according to any one of examples 248-250, wherein the pocket circumscribes a downstream portion of the device.

[0629] Example 252. The system according to any one of examples 217-251, wherein: the delivery tool comprises a catheter, transluminally advanceable to the heart, and the device comprises a shape -memory frame, such that the device has: a compressed state in which the device is transluminally advanceable, via the catheter, to the heart, and an expanded state in which an external diameter of the device is greater than an internal diameter of the native valve, such that a radial portion of the device presses towards tissue of the native valve.

[0630] Example 253. The system according to example 252, wherein: while the device is in the compressed state, the shape -memory frame has a tubular shape extending along a longitudinal axis, and while the device is in the expanded state, a first portion of the frameAttorney Docket No: TMTTMT- 24122WO01extends along the longitudinal axis, and a second portion of the frame extends radially away from the longitudinal axis.

[0631] Example 254. The system according to any one of examples 252-253, wherein: while the device is in the compressed state, the shape-memory frame has a tubular shape defining a medially-facing tube-interior and a radially-facing tube-exterior, and while the device is in the expanded state, a portion of the tube -interior defines a radially-facing portion of the frame.

[0632] Example 255. The system according to any one of examples 252-254, wherein: while the device is in the compressed state, the shape-memory frame has a tubular shape extending, along a longitudinal axis, from a proximal end to a distal end, and while the device is in the expanded state, a portion of the frame defines a toroidal space, circumscribing the longitudinal axis of the frame.

[0633] Example 256. The system according to any one of examples 252-255, wherein: the system further comprises a restraining element inhibiting expansion of an upstream portion of the device, wherein the delivery tool is configured to secure the device in the heart by: transluminally advancing the device to the heart, and while the restraining element inhibits expansion of the upstream portion of the device, positioning the device such that: a downstream portion of the device faces tissue of the native valve, and adjusting each of the restraining elements such that the device transitions toward the expanded state, such that the radial portion of the device presses towards tissue of the native valve, and subsequently, securing the device in the heart by adhering the skirt to the tissue.

[0634] Example 257. The system according to example 256, wherein: the restraining element is a first restraining element of a plurality of restraining elements, each restraining element inhibiting expansion of an upstream portion of the device, wherein the delivery tool is configured to secure the device in the heart by: transluminally advancing the device to the heart, and while the restraining elements inhibit expansion of the upstream portion of the device, positioning the device such that: the downstream portion of the device faces tissue of the native valve, and adjusting each of the restraining elements such that the device transitions toward the expanded state, such that the radial portion of the device presses towards tissue of the native valve, and subsequently, securing the device in the heart by adhering the skirt to the tissue.

[0635] Example 258. The system according to example 256, wherein the delivery tool is configured to secure the device in the heart by adhering the device to the tissue by dispensingAttorney Docket No: TMTTMT- 24122WO01the adhesive in contact with the skirt and the tissue, prior to releasing the restraining element from the device.

[0636] Example 259. The system according to any one of examples 256-258, wherein the delivery tool comprises the restraining element, and is configured to be withdrawn from the subject, leaving the device secured in the heart.

[0637] Example 260. The system according to any one of examples 256-259, wherein the restraining element is nonmetallic.

[0638] Example 261. The system according to any one of examples 256-260, wherein the restraining element is more flexible than the frame.

[0639] Example 262. The system according to any one of examples 256-261, wherein the restraining element is reversibly coupled to a nonmetallic portion of the device.

[0640] Example 263. The system according to any one of examples 256-262, wherein: the restraining element comprises a cord, coupled to at least three points along a perimeter of the upstream portion; and the delivery tool defines a distal portion reversibly coupled to the cord, the delivery tool configured to transcardially control expansion of the device toward the expanded state by controlling tension on the cord.

[0641] Example 264. The system according to example 263, wherein the delivery tool is configured to disengage from the cord and to withdraw from the subject, leaving the cord and the device within the subject.

[0642] Example 265. The system according to any one of examples 263-264, wherein the delivery tool is configured to facilitate expansion of the device by reducing tension on the cord.

[0643] Example 266. The system according to any one of examples 263-265, wherein: the frame defines a plurality of eyelets at the upstream portion; the cord is a first cord, threaded at the least three eyelets of the plurality in a first arc around the perimeter, such that transcardially controlling tension on the first cord controls expansion of a first sector of the perimeter, and the system further comprises a second cord, threaded through at least three eyelets of the plurality in a second arc around the perimeter, such that transcardially controlling tension on the second cord controls expansion of a second sector of the perimeter .

[0644] Example 267. The system according to example 266, wherein the delivery tool is operatively coupled to the first and second cords to, by transcardially controlling tension on theAttorney Docket No: TMTTMT- 24122WO01first and second cords independently of each other, control expansion of the first and second sectors independently of each other.

[0645] The described systems, apparatuses, devices, methods, etc. should not be construed as limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed implementations and applications, alone and in various combinations and sub-combinations with one another. The disclosed systems, apparatuses, devices, methods, etc. are not limited to any specific aspect, feature, or combination thereof, nor do the disclosed systems, apparatuses, devices, methods, etc. require that any one or more specific advantages be present or problems be solved.

[0646] Any of the various systems, assemblies, devices, components, apparatuses, etc. in this disclosure can be sterilized (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.) to ensure they are safe for use with patients, and the methods herein can comprise (or additional methods comprise or consist of) sterilization of the associated system, device, component, apparatus, etc. (e.g., with heat, radiation, ethylene oxide, hydrogen peroxide, etc.)

[0647] The techniques, methods, processes, operations, steps, etc. described or suggested herein or in the references incorporated herein, and any methods of using the systems, assemblies, apparatuses, devices, etc. herein, can be performed on a living subject (e.g., human, other animal, etc.) or on a simulation (e.g., a cadaver, cadaver heart, simulator, imaginary person, etc.). When performed on a simulation, the body parts, e.g., heart, tissue, valve, etc., can be assumed to be simulated or can optionally be referred to as “simulated” (e.g., simulated heart, simulated tissue, simulated valve, etc.) and can optionally comprise computerized and / or physical representations of body parts, tissue, etc. The term “simulation” covers use on a cadaver, computer simulator, imaginary person (e.g., if they are just demonstrating in the air on an imaginary heart), etc.

[0648] Various implementations of systems, devices, methods, etc. are disclosed herein, and any combination of their features, components, and options can be made unless specifically excluded. For example, various descriptions of implants 200, 200a, 200b, 200c and docking stations 300, 300a, 300b, 300d can be used with any appropriate delivery tools 120, 120a, 120b, 120d even if a specific combination is not explicitly described. For example, the implants and docking stations described hereinabove without reference to cushions 312, 314 or permeable material 350d can include the cushions and / or the permeable material, mutatis mutandis. InAttorney Docket No: TMTTMT- 24122WO01short, individual components of the disclosed systems can be combined unless mutually exclusive or physically impossible.

[0649] Although the operations of some of the disclosed methods are described in a particular, sequential order for convenient presentation, it should be understood that this manner of description encompasses rearrangement, unless a particular ordering is required by specific language set forth herein. For example, operations described sequentially can in some cases be rearranged or performed concurrently. Moreover, for the sake of simplicity, the attached figures may not show the various ways in which the disclosed systems, apparatuses, devices, methods, etc. can be used in conjunction with other systems, apparatuses, devices, methods, etc.

[0650] The present invention is not limited to the examples that have been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.

Claims

Attorney Docket No: TMTTMT- 24122WO01CLAIMS1. A system for use at a native valve of a heart of a subject, the system comprising:an expandable device and a skirt circumscribing at least a portion of the device; and a delivery tool:having a distal portion to which the device is couplable,comprising an applicator that contains an adhesive and comprises a nozzle that provides fluid communication between the applicator and the skirt, and configured to secure the device to the native valve by:pressing the skirt against tissue of the native valve, andadhering the skirt to the tissue by, via the nozzle, dispensing the adhesive between the skirt and the tissue.

2. The system according to claim 1, wherein the delivery tool is configured to secure the device to the native valve by pressing the skirt against tissue at an inlet of the native valve such that a downstream portion of the device is open toward the inlet of the native valve.

3. The system according to any one of claims 1 -2, wherein the distal portion of the delivery tool defines an arm to which the device is rigidly mountable.

4. The system according to any one of claims 1-3, wherein the device is shaped to have an upstream circumferential bulge at an upstream portion of the skirt and a downstream circumferential bulge at a downstream portion of the skirt.

5. The system according to any one of claims 1-4, wherein the portion is a valve portion that comprises a stent and prosthetic leaflets mounted within the stent.

6. The system according to any one of claims 1-5, wherein tire applicator is configured to dispense the adhesive via the nozzle, on a radial portion of the skirt, between the skirt and the tissue.

7. The system according to any one of claims 1-6, wherein the delivery tool is configured to withdraw the applicator from the device, leaving the device secured to the tissue.

8. The system according to any one of claims 1-7, wherein the applicator is a first applicator, and wherein the delivery tool comprises multiple applicators including the first applicator, the multiple applicators diverging from each other at the distal portion such that the nozzles of the applicators are distributed circumferentially around the skirt.Attorney Docket No: TMTTMT- 24122WO019. The system according to any one of claims 1-8, wherein the delivery tool comprises 2-12 applicators.

10. The system according to claim 9, wherein the delivery tool comprises 6-12 applicators.

11. The system according to any one of claims 1-10, wherein the skirt is radially spaced from the portion.

12. The system according to any one of claims 1-11, wherein the device comprises a frame having a radial portion that supports the skirt radially spaced from the portion.

13. The system according to any one of claims 1-12, wherein the skirt is configured to isolate the adhesive between the skirt and the tissue.

14. The system according to claim 13, wherein the device is configured to define an adhesive receptacle between the skirt and the tissue.

15. The system according to claim 14, wherein the adhesive receptacle circumscribes the device.

16. The system according to any one of claims 14-15, wherein the nozzle provides fluid communication between the applicator and the adhesive receptacle.

17. The system according to claim 16, wherein the nozzle is disposed at the adhesive receptacle.

18. The system according to any one of claims 14-17, wherein the device is shaped to have an upstream circumferential bulge upstream of the receptacle and a downstream circumferential bulge downstream of the receptacle.

19. The system according to any one of claims 14-18, wherein the device further comprises a permeable material disposed over the skirt, the permeable material configured to define at least a part of the adhesive receptacle between the skirt and the tissue.

20. The system according to claim 19, wherein the permeable material defines a circumferential boundary of the adhesive receptacle.

21. The system according to any one of claims 19-20, wherein the permeable material defines a toroidal adhesive receptacle between the skirt and the tissue.

22. The system according to any one of claims 19-21, wherein the permeable material has a greater absorbency than the skirt.Attorney Docket No: TMTTMT- 24122WO0123. The system according to any one of claims 19-22, wherein the material has a greater porosity than the skirt.

24. The system according to any one of claims 19-23, wherein the material is more hydrophilic than the skirt.

25. The system according to any one of claims 19-24, wherein the delivery tool is configured to dispense the adhesive, via the nozzle, between the skirt and the tissue such that some of the adhesive permeates the material and contacts the tissue.

26. The system according to any one of claims 19-25, wherein the delivery tool is configured to dispense the adhesive, via the nozzle, to the permeable material such that some of the adhesive permeates the material and contacts the tissue.

27. The system according to any one of claims 19-26, wherein the device comprises a pair of cushions, each cushion disposed on the skirt.

28. The system according to claim 27, wherein the permeable material is disposed over the skirt and each of the cushions, such that the permeable material defines at least a part of the adhesive receptacle between the cushions.

29. The system according to claim 28, wherein the delivery tool is configured to dispense the adhesive, via the nozzle, between the cushions and the tissue such that some of the adhesive permeates the material and contacts the tissue30. The system according to any one of claims 28-29, wherein the pair of cushions comprises an upstream cushion and a downstream cushion, such that the permeable material defines at least part of a circumferential adhesive receptacle between the cushions and the tissue.

31. The system according to any one of claims 19-30, wherein:the adhesive receptacle defines a pocket between the skirt and the permeable material, the nozzle opening into the pocket, andthe delivery tool is configured to dispense the adhesive, via the nozzle, between the skirt and the tissue by dispensing the adhesive into the pocket such that some of the adhesive permeates the material and contacts the tissue.

32. The system according to claim 31 , wherein the pocket circumscribes the skirt.

33. The system according to any one of claims 31-32, wherein the pocket is shaped to define a ring-shaped sleeve disposed on a radial portion of the skirt.Attorney Docket No: TMTTMT- 24122WO0134. The system according to any one of claims 31-33, wherein the pocket circumscribes a downstream portion of the device.

35. The system according to any one of claims 1-34, wherein:the delivery tool comprises a catheter, transluminally advanceable to the heart, and the device comprises a shape-memory frame, such that the device has:a compressed state in which the device is transluminally advanceable, via the catheter, to the heart, andan expanded state in which an external diameter of the device is greater than an internal diameter of the native valve, such that a radial portion of the device presses towards tissue of the native valve.

36. The system according to claim 35, wherein:while the device is in the compressed state, the shape-memory frame has a tubular shape extending along a longitudinal axis, andwhile the device is in the expanded state, a first portion of the frame extends along the longitudinal axis, and a second portion of the frame extends radially away from the longitudinal axis.

37. The system according to any one of claims 35-36, wherein:while the device is in the compressed state, the shape-memory frame has a tubular shape defining a medially-facing tube-interior and a radially-facing tube-exterior, andwhile the device is in the expanded state, a portion of the tube-interior defines a radially-facing portion of the frame.

38. The system according to any one of claims 35-37, wherein:while the device is in the compressed state, the shape-memory frame has a tubular shape extending, along a longitudinal axis, from a proximal end to a distal end, andwhile the device is in the expanded state, a portion of the frame defines a toroidal space, circumscribing the longitudinal axis of the frame.

39. The system according to any one of claims 35-38, wherein:the system further comprises a restraining element inhibiting expansion of an upstream portion of the device, wherein the delivery tool is configured to secure the device in the heart by:transluminally advancing the device to the heart, andAttorney Docket No: TMTTMT- 24122WO01while the restraining element inhibits expansion of the upstream portion of the device, positioning the device such that:a downstream portion of the device faces tissue of the native valve, and adjusting each of the restraining elements such that the device transitions toward the expanded state, such that the radial portion of the device presses towards tissue of the native valve, andsubsequently, securing the device in the heart by adhering the skirt to the tissue.

40. The system according to claim 39, wherein:the restraining element is a first restraining element of a plurality of restraining elements, each restraining element inhibiting expansion of an upstream portion of the device, wherein the delivery tool is configured to secure the device in the heart by:transluminally advancing the device to the heart, andwhile the restraining elements inhibit expansion of the upstream portion of the device, positioning the device such that:the downstream portion of the device faces tissue of the native valve, and adjusting each of the restraining elements such that the device transitions toward the expanded state, such that the radial portion of the device presses towards tissue of the native valve, andsubsequently, securing the device in the heart by adhering the skirt to the tissue.

41. The system according to claim 39, wherein the delivery tool is configured to secure the device in the heart by adhering the device to the tissue by dispensing the adhesive in contact with the skirt and the tissue, prior to releasing the restraining element from the device.

42. The system according to any one of claims 39-41 , wherein the delivery tool comprises the restraining element, and is configured to be withdrawn from the subject, leaving the device secured in the heart.

43. The system according to any one of claims 39-42, wherein the restraining element is nonmetallic.

44. The system according to any one of claims 39-43, wherein the restraining element is more flexible than the frame.

45. The system according to any one of claims 39-44, wherein the restraining element is reversibly coupled to a nonmetallic portion of the device.Attorney Docket No: TMTTMT- 24122WO0146. The system according to any one of claims 39-45, wherein:the restraining element comprises a cord, coupled to at least three points along a perimeter of the upstream portion; andthe delivery tool defines a distal portion reversibly coupled to the cord, the delivery tool configured to transcardially control expansion of the device toward the expanded state by controlling tension on the cord.

47. The system according to claim 46, wherein the delivery tool is configured to disengage from the cord and to withdraw from the subject, leaving the cord and the device within the subject.

48. The system according to any one of claims 46-47, wherein the delivery tool is configured to facilitate expansion of the device by reducing tension on the cord.

49. The system according to any one of claims 46-48, wherein:the frame defines a plurality of eyelets at the upstream portion;the cord is a first cord, threaded at the least three eyelets of the plurality in a first arc around the perimeter, such that transcardially controlling tension on the first cord controls expansion of a first sector of the perimeter, andthe system further comprises a second cord, threaded through at least three eyelets of the plurality in a second arc around the perimeter, such that transcardially controlling tension on the second cord controls expansion of a second sector of the perimeter .

50. The system according to claim 49, wherein the delivery tool is operatively coupled to the first and second cords to, by transcardially controlling tension on the first and second cords independently of each other, control expansion of the first and second sectors independently of each other.

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