Prosthetic valve docking device

Abstract

A docking device for securing a prosthetic valve at a native valve is provided. The docking device can include a coil and a guard member. The coil includes a plurality of helical turns when in a deployed orientation. The guard member is attached to the coil by being coupled to at least a portion of a helical turn thereof. The guard member includes a scaffold with a spine and a plurality of arms extending from the spine. The guard member is movable between a radially compressed state in a delivery orientation and a radially expanded state in the deployed orientation. The guard member can include one or more terminal lobes which may have apexes for ease of collapsibility. The coil may have coils with different lumen diameters and the guard member may include a radially inward portion to cover the space between the coils.

Description

Docket No.: TMTTM3-24264WO01PROSTHETIC VALVE DOCKING DEVICE CROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims the benefit of U.S. Provisional Patent Application No.63 / 945,656, filed December 19, 2025, U.S. Provisional Patent Application No. 63 / 808,392, filed May 19, 2025, and U.S. Provisional Patent Application No. 63 / 747,828 filed on January 21, 2025, all of which are incorporated by reference herein in their entirety.FIELD

[0002] The present disclosure relates to docking devices configured to secure a prosthetic valve at an implantation location.BACKGROUND

[0003] The human heart can suffer from various valvular diseases. These valvular diseases can result in significant malfunctioning of the heart and ultimately require repair of the native valve or replacement of the native valve with an artificial valve. There are a number of known repair devices (for example, stents) and artificial valves, as well as a number of known methods of implanting these devices and valves in humans. Percutaneous and minimally-invasive surgical approaches are used in various procedures to deliver prosthetic medical devices to locations inside the body that are not readily accessible by surgery or where access without surgery is desirable. In one specific example, a prosthetic heart valve can be mounted in a crimped state on the distal end of a delivery apparatus and advanced through the patient’s vasculature (for example, through a femoral artery and the aorta) until the prosthetic heart valve reaches the implantation site in the heart. The prosthetic heart valve is then expanded to its functional size, for example, by inflating a balloon on which the prosthetic valve is mounted, actuating a mechanical actuator that applies an expansion force to the prosthetic heart valve, or by deploying the prosthetic heart valve from a sheath of the delivery apparatus so that the prosthetic heart valve can self-expand to its functional size.

[0004] In some instances, a docking device can be implanted at a location within a patient’s vasculature prior to implanting the prosthetic heart valve. The docking device can be configured to position and / or secure the prosthetic heart valve relative to the native anatomy.SUMMARYDocket No.: TMTTM3-24264WO01

[0005] Described herein are prosthetic heart valves, delivery apparatus, and methods for implanting prosthetic heart valves. The disclosed prosthetic heart valves, delivery apparatus, and methods can, for example, provide increased stability and improved sealing. As such, the devices and methods disclosed herein can, among other things, overcome one or more of the deficiencies of typical prosthetic heart valves and their delivery apparatus.

[0006] In some examples, a guard member, for a docking device for securing a prosthetic implant at a native valve comprises a scaffold with a spine defining an arc in a deployed orientation and comprising a first end portion and a second end portion; and a terminal lobe extending from the first end portion of the spine, the terminal lobe comprising an apex pointed towards the second end portion of the spine, wherein the guard member is movable between a radially compressed state in a delivery orientation and a radially expanded state in the deployed orientation. In some examples, the guard member further comprises a plurality of arms extending from the spine. In some examples, the guard member further comprises an arm extending from the apex of the terminal lobe. In some examples, the terminal lobe is a first terminal lobe and the guard member further comprises a second terminal lobe, and the second terminal lobe comprises a second apex pointed towards the first end portion of the spine. In some examples, the guard member further comprises a flap fitted over the scaffold. In some examples, a docking device comprises a guard member and a coil comprising at least one helical turn, wherein the guard member is attached to at least a portion of the at least one helical turn.

[0007] In some examples, a guard member, for a docking device for securing a prosthetic implant at a native valve comprises: a spine which comprises a first end portion and a second end portion and defines an arc extending from the first end portion to the second end portion in a deployed orientation; a terminal lobe extending from the first end portion of the spine; and one or more arms coupled to the spine between the first end portion and the second end portion and each arm of the one or more arms comprising a head portion which is disposed radially outward from the spine and in a first circumferential direction, wherein the one or more arms comprises a first arm which is disposed adjacent to the terminal lobe, and wherein the first arm further comprises a second distal end portion disposed radially outward from the spine and in a second circumferential direction, wherein the guard member is movable between a radially compressed state in a delivery orientation and a radially expanded state in the deployed orientation. In some examples, the guard member further comprises a cover extending over at least one of the spine, the terminal lobe, and the one or more arms. In someDocket No.: TMTTM3-24264WO01examples, a docking device comprises the guard member and a coil, wherein the guard member is sutured to the coil.

[0008] In some examples, a guard member, for a docking device for securing a prosthetic implant at a native valve, comprises: a curved spine which defines a plane; and a plurality of arms extending from the spine and defining a first angle relative to the plane, wherein the first angle is within a range of 5-80 degrees, wherein the guard member is movable between a radially compressed state in a delivery orientation and a radially expanded state in a deployed orientation. In some examples, the first angle is within a range of 15-60 degrees. In some examples, the first angle is in a range of 20-40 degrees. In some examples, the guard member further comprises a first terminal lobe extending from a first end portion of the curved spine. In some examples, the guard member further comprises a second terminal lobe extending from a second end portion of the curved spine. In some examples, the first terminal lobe and / or the second terminal lobe extends from the spine such that the first terminal lobe and / or the second terminal lobe define a second angle relative to the plane. In some examples, the second terminal lobe comprises a distal end portion defining a third angle relative to the plane, wherein third angle is greater than the second angle.

[0009] In some examples, a docking device for securing a prosthetic valve comprises: a coil comprising: a longitudinal axis extending through a lumen of the coil from an inflow side to an outflow side; a first coil region defining a first lumen diameter and configured to be disposed on the inflow side of a native annulus and to stabilize the coil relative to the native annulus; and a second coil region extending from a distal end of the first coil region and comprising one or more helical turns each defining a second lumen diameter and configured to be disposed on an outflow side of a native annulus and to receive a prosthetic valve, wherein the first lumen diameter is in a range of 10 percent to 30 percent greater than the second lumen diameter; and a guard member comprising: a curved spine comprising a radially inward portion; and one or more inner stmts extending radially inward from the curved spine. In some examples, the guard member further comprises one or more terminal lobes. In some examples, the guard member further comprises one or more outer arms extending radially outward from the spine.

[0010] In some examples, the guard member comprises: a spine defining an arc, the arc extending between a first end portion and a second end portion; one or more cells extending radially inward from the spine; one or more arms extending radially outward from the spine; a first terminal lobe and a second terminal lobe, wherein the first terminal lobe is disposed atDocket No.: TMTTM3-24264WO01the first end portion and the second terminal lobe is disposed at the second end portion of the spine. In some examples, the one or more cells are closed cells relative to the spine. In some examples, the one or more cells are open cells relative to the spine. In some examples, the one or more cells extending radially inward from the spine each comprise a first stmt, a second stmt, and a third stmt, wherein a first end of each of the first stmt and third stmt is coupled to the spine and a second end of each of the first stmt and third strut is coupled to the second stmt. In some examples, the one or more cells extending radially inward comprises five cells. In some examples, the one or more cells extending radially inward comprises four cells. In some examples, the guard member is configured to be coupled to a coil of a docking device and the one or more cells are configured to extend radially inward from the coil and the one or more arms, the first terminal lobe, and the second terminal lobe are configured to extend radially outward from the coil. In some examples, the guard member further comprises a flap. In some examples, a docking device comprises the guard member and a coil attached to the guard member, wherein the coil comprises a lumen configured to receive a prosthetic heart valve.

[0011] In some examples, a guard member, for a docking device for securing a prosthetic implant at a native valve, comprises: a spine defining an arc, the arc extending between a first end portion and a second end portion; one or more strut elements extending radially inward from the spine; one or more arms extending radially outward from the spine; two terminal lobes, wherein the terminal lobes are disposed at the first end portion and the second end portion of the spine. In some examples, each of the one or more strut elements comprise a plurality of struts. In some examples, each of the one or more strut elements defines a cell and each cell comprises four stmts.

[0012] In some examples, a guard member, for a docking device for securing a prosthetic implant at a native valve, comprises: a first spine comprising a first end portion and a second end portion and defining an arc between the first end portion and the second end portion; and a second spine disposed radially inward from the first spine and comprising a first end portion and a second end portion. In some examples the guard member further comprises one or more arms extending radially outward from the first spine. In some examples, the guard member further comprises a first terminal lobe disposed at the first end portion of the first spine; and a second terminal lobe disposed at the second end portion of the first spine. In some examples, the first end portion and the second end portion of the second spine are coupled to the first spine. In some examples, the second spine has a zig-zag pattern. In someDocket No.: TMTTM3-24264WO01examples, the first end portion of the second spine is coupled to the first spine, and wherein the second end portion of the second spine is not coupled to the first spine. In some examples, the second spine comprises a first segment and a second segment. In some examples, a first segment of the second spine is coupled to the first end portion of the first spine, wherein the second segment of the second spine is coupled to the second end portion of the first spine, and wherein the first and second segments of the second spine extend circumferentially towards each other. In some examples, the guard member further comprises a flap. In some examples, a docking device comprises the guard member and further comprises a coil, wherein the guard member is configured to be attached to the coil by being coupled to at least a portion of a helical turn thereof.

[0013] In some examples a method comprises delivering the docking device of any example herein to a native valve via a delivery apparatus, wherein the coil of the docking device is in an axially-elongate configuration; deploying the docking device from the delivery apparatus at an annulus of the native valve, wherein the docking device moves from the axially-elongate configuration to a deployed orientation; and deploying a prosthetic valve from the delivery apparatus into the docking device.

[0014] In some examples, a guard member, for a docking device for securing a prosthetic implant at a native valve, the guard member comprises: a spine defining an arc, the arc extending between a first end portion and a second end portion; and one or more cells extending radially inward from the spine, wherein the one or more cells each comprise a first stmt, a second stmt, and a third stmt, wherein a first end of each of the first stmt and third stmt is coupled to the spine and a second end of each of the first stmt and third stmt is coupled to the second stmt, wherein the guard member is movable between a compressed state and an expanded state, and wherein when the guard member is in the expanded state, the first stmt forms an angle with the second stmt between 30 degrees and 60 degrees.

[0015] In some examples, the guard member further comprises one or more arms coupled to the spine and extending radially outward and the first end of the first stmt is coupled to the spine at a position on the spine proximal to an arm of the one or more arms, and the first end of the third stmt is coupled to the spine at a position on the spine distal to the arm of the one or more arms. In some examples, when the guard member is in the expanded state, the one or more cells extending radially inward extend between 1 mm to 3 mm radially inward from the spine. In some examples, the guard member further comprises a cover wherein the cover is disposed around the spine and the one or more cells. In some examples, a docking device forDocket No.: TMTTM3-24264WO01securing a prosthetic implant at a native valve, comprising a guard member and further comprises a coil, wherein the guard member is configured to be attached to the coil by being coupled to at least a portion of a helical turn thereof.

[0016] In some examples, a guard member, for a docking device for securing a prosthetic implant at a native valve comprises a spine defining an arc, the arc extending between a first end portion and a second end portion; and one or more cells extending radially inward from the spine wherein the one or more cells each comprise a curved strut which each extend from a first position on the spine to a second position on the spine, wherein the first position is closer to the first end portion and the second position is closer to the second end portion, wherein the guard member is movable between a compressed state and an expanded state.

[0017] In some examples, a curve of each of the curved struts is opposite to a curve of the arc defined by the spine. In some examples, the guard member further comprises one or more arms coupled to the spine and extending radially outward and wherein the first position and the second position are radially offset from a base portion of the one or more arms. In some examples, each of the curved struts defines a first length and a portion of the spine between the first position and the second position defines a second length and wherein the first length is equal to the second length. In some examples, the curved struts each define a first length and a portion of the spine between the first position and the second position defines a second length and wherein the first length is between 1 percent to 5 percent greater than the second length.

[0018] In some examples, a guard member, for a docking device for securing a prosthetic implant at a native valve, the guard member comprising: a scaffold wherein the scaffold defines at least a partial an anulus around a central point the anulus comprising an outer radius and an inner radius; and a cover disposed around the scaffold covering at least a portion of an area between the inner radius and the outer radius and comprising a hole positioned between the inner radius and the outer radius and configured allow a coil of the docking device to pass through the cover, wherein the guard member is movable between a compressed state and an expanded state and wherein the guard member is configured to be coupled at least partially to an outflow side of a first coil region of the coil.

[0019] In some examples, the guard member comprises a medial terminal lobe and the hole is located adjacent to the medial terminal lobe. In some examples, the guard member comprises a medial terminal lobe and the hole is located on the medial terminal lobe. Tn someDocket No.: TMTTM3-24264WO01examples, the scaffold comprises a bend portion which bends inward towards the central point and which is configured to wrap around a coil of a first coil region of the docking device. In some examples, the hole is positioned adjacent to the bend portion.

[0020] In some examples, a docking device comprises the guard member of any example herein and further comprises a coil, wherein the coil comprises a first coil region configured to be disposed on an inflow side of a native annulus and to stabilize the coil relative to the native annulus.

[0021] In some examples, a guard member, for a docking device for securing a prosthetic implant at a native valve, the guard member comprising: a scaffold wherein the scaffold defines at least a partial an anulus around a central point the anulus comprising an inner radius and an outer radius; and a bend portion disposed on the scaffold and extending inward towards the central point wherein the bend portion is configured to wrap around a coil of a first coil region of the docking device, wherein the guard member is movable between a compressed state and an expanded state and wherein the guard member is configured to be coupled at least partially to an outflow side of the coil of the first coil region. In some examples, the guard member comprises a medial terminal lobe and wherein the bend portion is located adjacent to the medial terminal lobe. In some examples, the guard member comprises a medial terminal lobe and wherein the bend portion is located on the medial terminal lobe.

[0022] In some examples, a docking device for securing a prosthetic valve comprises: a coil comprising: a longitudinal axis extending through a lumen of the coil from an inflow side to an outflow side; a first coil region configured to be disposed on the inflow side of a native annulus and to stabilize the coil relative to the native annulus; a second coil region extending from a distal end of the first coil region and comprising one or more helical turns and configured to be disposed on an outflow side of a native annulus and to receive a prosthetic valve; and a guard member comprising: a scaffold which defines at least a partial an anulus around a central point the anulus comprising an inner radius and an outer radius; and a cover disposed around the scaffold and comprising a hole positioned between the inner radius and the outer radius and configured allow the coil of the first coil region to pass through the cover.

[0023] In some examples, the scaffold comprises a bend portion which bends inward towards the longitudinal axis and which is configured to wrap around a coil of a first coil region. InDocket No.: TMTTM3-24264WO01some examples, the hole is positioned adjacent to the bend portion. In some examples, the guard member comprises a medial terminal lobe, and wherein the hole is located adjacent to the medial terminal lobe. In some examples, the guard member comprises a medial terminal lobe, and wherein the hole is located on the medial terminal lobe.

[0024] In some examples, a docking device for securing a prosthetic valve comprises a first coil region configured to be disposed on an inflow side of a native annulus and to stabilize the docking device relative to the native annulus, wherein the first coil region defines a first circle; and a second coil region extending from a distal end of the first coil region and comprising one or more helical turns configured to be disposed on an outflow side of a native annulus and to receive a prosthetic valve wherein the second coil region defines a second circle, wherein prior to implantation of a prosthetic heart valve the first circle defines a first center point and a first radius and the second circle defines a second center point and a second radius, wherein the first center point is spatially offset from the second center point.

[0025] In some examples, the first radius is larger than the second radius. In some examples, the first circle and the second circle are internally tangent circles. In some examples, the first circle and the second circle overlap at a proximal end portion of the first coil region.

[0026] In some examples, the first coil region is configured to overlap a portion of the native annulus. In some examples, the native annulus is a mitral valve and when the docking device is installed, the first coil region is configured to engage a posterior leaflet. In some examples, the first coil region is configured to engage a P2 / P3 region of the posterior leaflet of the mitral valve.

[0027] In some examples, a docking device for securing a prosthetic valve comprises: a first coil region configured to be disposed on an inflow side of a native annulus and to stabilize the docking device relative to the native annulus, wherein the first coil region defines a first longitudinal axis extending through a lumen of the first coil region from an inflow side to an outflow side; and a second coil region extending from a distal end of the first coil region and comprising one or more helical turns configured to be disposed on an outflow side of a native annulus and to receive a prosthetic valve wherein the second coil region defines a second longitudinal axis parallel to the first longitudinal axis, wherein the first longitudinal axis is offset from the second longitudinal axis such that when docking device is installed at the native annulus, the first coil region is configured to overlap a portion of the native annulus.Docket No.: TMTTM3-24264WO01

[0028] In some examples, a docking device for securing a prosthetic valve comprises: a first coil region configured to be disposed on an inflow side of a native annulus and configured to stabilize the docking device relative to the native annulus; and a second coil region extending from a distal end of the first coil region and comprising one or more helical turns configured to be disposed on an outflow side of a native annulus and to receive a prosthetic valve wherein the second coil region defines a longitudinal axis extending through a lumen of the second coil region from an inflow side to an outflow side, wherein each helical turn of the second coil region lies substantially within a nominal radius about the longitudinal axis, wherein a portion of the first coil region extends radially outward from the nominal radius of the second coil region, and wherein a proximal end portion of the first coil region is disposed at the nominal radius relative to the longitudinal axis.

[0029] In some examples, a guard member for a docking device for securing a prosthetic implant at a native valve comprises: a scaffold comprising a spine; a cover disposed around the scaffold; and a marker coupled to the scaffold, wherein the guard member is movable between a compressed state and an expanded state.

[0030] In some examples, the marker is a 3D marker. In some examples, the marker is a spherical marker. In some examples, the marker comprises a through-hole.

[0031] In some examples, the scaffold comprises a medial terminal lobe and the marker is coupled to the medial terminal lobe.

[0032] In some examples, the scaffold comprises a retention feature and the marker is coupled to the retention feature. In some examples, the retention feature is formed out of a unitary piece with the scaffold. In some examples, the retention feature is a circle. In some examples, the retention feature is a rounded rectangle. In some examples, the retention feature is positioned out of a plane defined by the scaffold. In some examples, the marker is coined within the retention feature.

[0033] In some examples, a suture stitches the marker to the cover.

[0034] In some examples, the cover defines a pocket around the medial terminal lobe of the scaffold and the marker is positioned inside the pocket.

[0035] In some examples, a method comprises: delivering the assembly of any one of examples 95-96 to a native valve; and deploying the assembly at an annulus of the native valve, wherein the assembly remains in an axially-elongate configuration when delivering the assembly and moves to a deployed orientation after the docking device is deployed.Docket No.: TMTTM3-24264WO01

[0036] In some examples, the coil comprises a first coil region and a second coil region, and the method further comprises positioning the assembly such that a portion where the first coil region and the second coil region meet is positioned where the coil crosses the annulus.

[0037] In some examples, the coil crosses the annulus at a mitral valve medial commissure.

[0038] In some examples, a method comprises: delivering a docking device comprising a coil and a guard member to a native annulus; and positioning a marker on an atrial side of the native annulus wherein the marker is coupled to the guard member.

[0039] In some examples, the guard member comprises a medial terminal lobe and the marker is positioned on the medial terminal lobe.

[0040] In some examples, the method comprises determining a clocking position of the docking device based on a position of the marker.

[0041] Example 104. The method of any example herein, particularly any one of examples 101-103, further comprising deploying a prosthetic heart valve within the docking device.

[0042] In some examples, a method for assembling a guard member for a docking device comprises: forming a spine out of a first piece of material; forming a plurality of amis out of a second piece of material; and attaching the plurality of amis to the spine, wherein the spine is a curved spine, and wherein the arms are attached to the spine such that the arms extend radially outward from the spine.

[0043] In some examples, the first piece of material comprises a cross section that is rectangular.

[0044] In some examples, forming the spine comprises cutting the spine out of a first piece of material, and wherein forming the plurality of anus comprises cutting the plurality of arms out of a second piece of material. In some examples, the first piece of material is a sheet of material and the second piece of material is a wire.

[0045] In some examples, attaching the plurality of amis to the spine comprises welding a first end of each arm of the plurality of arms to the spine.

[0046] In some examples, forming the plurality of arms out of the second piece of material comprises forming head portions at a radially outward portion of each arm of the plurality of arms.Docket No.: TMTTM3-24264WO01

[0047] In some examples, a guard member for a docking device for securing a prosthetic implant at a native valve comprises: a spine and an arm extending radially outward from the spine; and a flap fitted over the scaffold; and a plurality of stitches, wherein the flap is attached to the arm by the plurality of stitches, wherein the plurality of stitches extend radially outward along the arm.

[0048] In some examples, the plurality of stitches are formed by a continuous length of suture. In some examples, the suture comprises an outer diameter in a range between 0.01 mm and 0.75 mm. In some examples, the suture comprises an outer diameter of 0.05 mm.

[0049] In some examples, the arm is one of a plurality of arms and wherein the plurality of stitches attaches the flap to each arm of the plurality of arms.

[0050] In some examples, the guard member comprises a first side configured to be positioned on an annuls of a native valve and wherein the plurality of stitches on the first side extend parallel to the arm.

[0051] In some examples, a method for assembling a guard member for a docking device comprises: fitting a flap over a scaffold, wherein the scaffold comprises a spine and an ami extending radially outward from the spine; and attaching the flap to the scaffold by forming a plurality of stitches spaced along the ami.

[0052] In some examples, the guard member comprises a first side configured to be positioned on an annuls of a native valve and wherein forming a plurality of stitches spaced along the arm comprises disposing the stitches on the first side so that they are parallel to the arm.

[0053] The above method(s) can be performed on a living animal or on a simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example, with body parts, heart, tissue, etc. being simulated).

[0054] The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, claims, and accompanying figures.Docket No.: TMTTM3-24264WO01BRIEF DESCRIPTION OF THE DRAWINGS

[0055] FIG. 1 A is a cutaway view of the human heart in a diastolic phase.

[0056] FIG. IB is a cutaway view of the human heart in a systolic phase.

[0057] FIG. 2A schematically illustrates a first stage in an exemplary mitral valve replacement procedure where a guide catheter and a guidewire are inserted into a vasculature of a patient and navigated through the vasculature and into a heart of the patient, towards a native mitral valve of the heart.

[0058] FIG. 2B schematically illustrates a second stage in the exemplary mitral valve replacement procedure where a docking device delivery apparatus extending through the guide catheter is used to deploy a docking device at the native mitral valve.

[0059] FIG. 3A schematically illustrates a third stage in the exemplary mitral valve replacement procedure where the docking device of FIG. 2B is fully implanted at the native mitral valve of the patient and the docking device delivery apparatus has been removed from the patient.

[0060] FIG. 3B schematically illustrates a fourth stage in the exemplary mitral valve replacement procedure where a prosthetic heart valve delivery apparatus extending through the guide catheter is used to deploy a prosthetic heart valve within the implanted docking device at the native mitral valve.

[0061] FIG. 4A schematically illustrates a fifth stage in the exemplary mitral valve replacement procedure where the prosthetic heart valve is fully implanted within the docking device at the native mitral valve and the prosthetic heart valve delivery apparatus has been removed from the patient.

[0062] FIG. 4B schematically illustrates a sixth stage in the exemplary mitral valve replacement procedure where the guide catheter and the guidewire have been removed from the patient.

[0063] FIG. 5 depicts a coil of a docking device according to one example.

[0064] FIG. 6 depicts a coil of a docking device according to another example.

[0065] FIG. 7 depicts a docking device comprising a coil with a guard member attached.

[0066] FIG. 8 depicts a scaffold with a plurality of arms and two terminal lobes.Docket No.: TMTTM3-24264WO01

[0067] FIG. 9 depicts a partial cross section showing a portion of the scaffold in a radially compressed state.

[0068] FIGS. 10-11 depict aspects of the scaffold where the scaffold is not entirely flat or planar.

[0069] FIG. 12 depicts the docking device of FIG. 7 with a prosthetic implant installed within the docking device.

[0070] FIG. 13 depicts a scaffold with a plurality of arms and two terminal lobes according to another example.

[0071] FIGS. 14A-14B depict partial scaffolds according to some examples.

[0072] FIG. 15 depicts a docking device which has a stabilization turn with a first lumen diameter which can be larger than a second lumen diameter of the coils in the central region.

[0073] FIG. 16 depicts a docking device according to another example which has a stabilization turn with a first lumen diameter which can be larger than a second lumen diameter of the coils in the central region and a guard member with a radially inward portion.

[0074] FIGS. 17-18 depict a scaffold for a guard member with a radially inward portion comprising a plurality of cells.

[0075] FIG. 19 depicts a scaffold for a guard member according to another example, with a radially inward portion comprising a plurality of cells.

[0076] FIGS. 20A-20B depict partial views of scaffolds according to other examples.

[0077] FIGS. 21-22 depict scaffolds according to other examples wherein the radially inward portion of the scaffold comprises cells with fewer than four struts.

[0078] FIG. 23 depicts a scaffold according to another example with a variety of exemplary radially inward portions.

[0079] FIGS. 24-28 depict scaffolds according to other examples which comprise a radially inward portion with a single cell which is formed by a second spine which is disposed radially inward from the main spine.

[0080] FIG. 29 depicts a scaffold according to another example with radially inward cells with an apex with a large angle.Docket No.: TMTTM3-24264WO01

[0081] FIG. 30 depicts a docking device comprising a scaffold similar to the scaffold of FIG.29.

[0082] FIG. 31 depicts a scaffold according to another example with radially inward cells each formed from a single curved strut.

[0083] FIG. 32 depicts an enlarged view of a single cell of the scaffold of FIG. 31.

[0084] FIG. 33 depicts a scaffold according to another example with radially inward cells each formed from a single curved strut.

[0085] FIG. 34 depicts a docking device with an annular guard member and a hole disposed between the inner radius of the guard member and the outer radius of the guard member.

[0086] FIGS. 35A-35B depict the underside of the guard member of FIG. 34.

[0087] FIGS. 36A-36B depict a scaffold with a bend portion designed to wrap around a stabilization turn of a coil.

[0088] FIG. 37 depicts the scaffold of FIGS. 36A-36B in a flattened configuration.

[0089] FIG. 38 depicts a scaffold with a bend portion designed to wrap around a stabilization turn of a coil, according to another example.

[0090] FIG. 39 depicts a partial scaffold including radially inward cells with a bend portion designed to wrap around a stabilization turn of a coil, according to yet another example.

[0091] FIG. 40 depicts a top down view of a docking device with an atrial turn which is offset from the circle formed by the functional turns.

[0092] FIG. 41 depicts a cutaway view of the heart showing the docking device of FIG. 40 implanted at the native mitral valve.

[0093] FIG. 42 depicts a docking device with a guard member that includes a radiopaque marker positioned on the medial terminal lobe.

[0094] FIGS. 43 A-43C depicts steps for attaching a spherical radiopaque marker with a through-hole to the flap of the guard member using a suture stitching pattern.

[0095] FIG. 44 illustrates an alternative radiopaque marker configuration where the radiopaque marker is positioned inside the flap material of the guard member.

[0096] FIGS. 45A-45F depict various scaffold modifications for marker retention features.Docket No.: TMTTM3-24264WO01

[0097] FIGS. 46A-46B depict a manufacturing method with a modular approach where the spine is cut from sheet material and arms / other components are formed separately.

[0098] FIG. 47 depicts the modular assembly process of the manufacturing method of FIGS.46A-46B.

[0099] FIGS. 48A-48D illustrate a first suture pattern for attaching a flap to the scaffold of a guard member.

[0100] FIGS. 49A-49D illustrate a second suture pattern for attaching the flap to the scaffold.DETAILED DESCRIPTIONGeneral Considerations

[0101] For purposes of this description, certain aspects, advantages, and novel features of examples of this disclosure are described herein. The disclosed methods, apparatus, and systems should not be construed as being limiting in any way. Instead, the present disclosure is directed toward all novel and nonobvious features and aspects of the various disclosed examples, alone and in various combinations and sub-combinations with one another. The methods, apparatus, and systems are not limited to any specific aspect or feature or combination thereof, nor do the disclosed examples require that any one or more specific advantages be present or problems be solved.

[0102] Although the operations of some of the disclosed examples 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 below. For example, operations described sequentially may 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 methods can be used in conjunction with other methods. Additionally, the description sometimes uses terms like “provide” or “achieve” to describe the disclosed methods. These terms are high-level abstractions of the actual operations that are performed. The actual operations that correspond to these terms may vary depending on the particular implementation and are readily discernible by one of ordinary skill in the art.

[0103] As used in this application and in the claims, the singular forms “a,” “an,” and “the” include the plural forms unless the context clearly dictates otherwise. Additionally, the termDocket No.: TMTTM3-24264WO01“includes” means “comprises.” Further, the term “coupled” generally means physically, mechanically, chemically, magnetically, and / or electrically coupled or linked and does not exclude the presence of intermediate elements between the coupled or associated items absent specific contrary language.

[0104] As used herein, the term “proximal” refers to a position, direction, or portion of a device that is closer to the user and further away from the implantation site. As used herein, the term “distal” refers to a position, direction, or portion of a device that is further away from the user and closer to the implantation site. Thus, for example, proximal motion of a device is motion of the device away from the implantation site and toward the user (for example, out of the patient’s body), while distal motion of the device is motion of the device away from the user and toward the implantation site (for example, into the patient’s body). The terms “longitudinal" and “axial” refer to an axis extending in the proximal and distal directions, unless otherwise expressly defined.

[0105] As used herein, “e.g.” means “for example,” and “i.e.” means “that is.” Examples of the Disclosed Technology

[0106] Described herein are various systems, apparatuses, methods, or the like, that can be used in or with delivery apparatuses to deliver a prosthetic implant (for example, a prosthetic valve, a docking device, etc.) into a patient body.

[0107] In certain examples, a delivery apparatus can be configured to deliver and implant a docking device at an implantation site, such as a native valve annulus. The docking device can be configured to more securely hold an expandable prosthetic valve implanted within the docking device, at the native valve annulus. For example, a docking device can provide or form a more circular and / or stable anchoring site, landing zone, or implantation zone at the implant site, in which a prosthetic valve can be expanded or otherwise implanted. By providing such anchoring or docking devices, replacement prosthetic valves can be more securely implanted and held at various valve annuluses, including at the mitral annulus which does not have a naturally circular cross-section.

[0108] In some examples, the docking device can be arranged within an outer shaft of the delivery apparatus. A sleeve shaft can cover or surround the docking device within the delivery apparatus and during delivery to a target implantation site. A pusher shaft can be disposed within the outer shaft, proximal to the docking device, and configured to push the docking device out of the outer shaft to position the docking device at the target implantation site. TheDocket No.: TMTTM3-24264WO01sleeve shaft can also surround the pusher shaft within the outer shaft of the delivery apparatus. After positioning the docking device at the target implantation site, the sleeve shaft can be removed from the docking device and retracted back into the outer shaft of the delivery apparatus.

[0109] Fluid (for example, a flush fluid, such as heparinized saline or the like) can be provided to a pusher shaft lumen defined within an interior of the pusher shaft, a delivery shaft lumen defined between the sleeve shaft and the outer shaft of the delivery apparatus, and a sleeve shaft lumen defined between the pusher shaft and the sleeve shaft. By providing a consistent flow of fluid through these lumens of the delivery apparatus, stagnation of blood within the delivery apparatus can be reduced or avoided, thereby reducing a risk of thrombus formation.

[0110] FIGS. 1A and IB are cutaway views of the human heart (H) in diastolic and systolic phases, respectively. The right ventricle (RV) and left ventricle (LV) are separated from the right atrium (RA) and left atrium (LA), respectively, by the tricuspid valve (TV) and the mitral valve (MV); i.e., the atrioventricular valves. Additionally, the aortic valve (AV) separates the left ventricle (LV) from the ascending aorta (AA) and the pulmonary valve (PV) separates the right ventricle from the pulmonary artery (PA). Each of these valves has flexible leaflets extending inward across the respective orifices that come together or "coapt" in the flowstream to form one-way, fluid-occluding surfaces. The docking stations of the present application are described, for illustration, primarily with respect to the inferior vena cava (IVC), superior vena cava (SVC), mitral valve MV, and aorta / aortic valve. A defective mitral valve can suffer from insufficiency and / or regurgitation.

[0111] The blood vessels, such as the aorta, inferior vena cava IVC, superior vena cava SVC, pulmonary artery PA, may be healthy or may be dilated, distorted, enlarged, have an aneurysm, or be otherwise impaired. Anatomical structures of the right atrium RA, right ventricle RV, left atrium LA, and left ventricle LV will be explained in greater detail. The devices described herein can be used in various areas whether explicitly described herein or not, e.g., in the inferior vena cava IVC and / or superior vena cava SVC, in the aorta (e.g., an enlarged aorta) as treatment for a defective mitral valve, in other areas of the heart or vasculature, in grafts, etc.

[0112] The right atrium RA receives deoxygenated blood from the venous system through the superior vena cava SVC and the inferior vena cava IVC, the former entering the right atrium from above, and the latter from below. The hepatic veins 17 carry blood from the liver to the inferior vena cava IVC. The coronary sinus (CS) is a collection of veins joined together to formDocket No.: TMTTM3-24264WO01a large vessel that collects deoxygenated blood from the heart muscle (myocardium), and delivers it to the right atrium RA. During the diastolic phase, or diastole, seen in FIG. 1 A, the deoxygenated blood from the inferior vena cava IVC, superior vena cava SVC, and coronary sinus CS that has collected in the right atrium RA passes through the tricuspid valve TV and into the right ventricle RV as the right ventricle RV expands, while blood from the left atrium LA passes through the mitral valve MV into the left ventricle LV. In the systolic phase, or systole, seen in FIG. IB, the right ventricle RV contracts to force the deoxygenated blood collected in the right ventricle RV through the pulmonary valve PV and pulmonary artery into the lungs, while the left ventricle LV contracts to force blood in the left ventricle through the mitral valve MV into the left atrium LA.

[0113] The devices described herein can be used to supplement the function of a defective mitral valve. During systole, the leaflets of a normally functioning mitral valve MV close to prevent the blood from regurgitating back into the left atrium LA. When the mitral valve MV does not operate normally, blood can backflow or regurgitate into the left atrium LA. Blood regurgitating backward into the left atrium LA increases the volume of blood in the atrium and the blood vessels that direct blood to the heart. This can cause the left atrium LA to enlarge and cause blood pressure to increase in the left atrium LA and blood vessels, which can cause damage to and / or swelling of the liver, kidneys, legs, other organs, etc. A transcatheter valve (THV) implanted in the mitral valve MV can inhibit blood from backflowing into the left atrium LA during the systolic phase.

[0114] The left atrium LA receives oxygenated blood from the left and right pulmonary veins, which then travels through the mitral valve to the left ventricle. During the diastolic phase, or diastole, seen in FIG. 1A, the oxygen rich blood that collects in the left atrium LA passes through the mitral valve MV and into the left ventricle LV as the left ventricle LV expands. In the systolic phase, or systole, seen in FIG. IB, the left ventricle LV contracts to force the oxygen rich blood through the aortic valve AV and aorta into the body through the circulatory system. In certain examples, the devices described herein can be used to supplement or replace the function of a defective mitral valve MV.

[0115] An exemplary transcatheter heart valve replacement procedure which utilizes a first delivery apparatus to deliver a docking device to a native valve annulus and then a second delivery apparatus to deliver a prosthetic transcatheter heart valve (for example, THV) inside the docking device is depicted in the schematic illustrations of FIGS. 2A-4B.Docket No.: TMTTM3-24264WO01

[0116] As introduced above, defective native heart valves may be replaced with THVs. However, in certain instances, such THVs may not be able to sufficiently secure themselves to the native tissue (for example, to the leaflets and / or annulus of the native heart valve) and may undesirably shift around relative to the native tissue, leading to paravalvular leakage (PVL), valve malfunction, and / or other issues. Thus, a docking device may be implanted first at the native valve annulus and then the THV can be implanted within the docking device to help anchor the THV to the native tissue and provide a seal between the native tissue and the THV.

[0117] FIGS. 2A-4B depict an exemplary transcatheter heart valve replacement procedure (for example, a mitral valve replacement procedure) which utilizes a docking device 52 (e.g., with guard member as described herein) and a prosthetic heart valve 62, according to one example. During the procedure, a user can create a pathway to a patient’s native heart valve using a guide catheter 30 (FIG. 2A). The user can deliver and implant the docking device 52 at the patient's native heart valve using a docking device delivery apparatus 50 (FIG. 2B) and then removes the docking device delivery apparatus 50 from the patient 10 after implanting the docking device 52 (FIG. 3A). The user can then implant the prosthetic heart valve 62 within the implanted docking device 52 using a prosthetic valve delivery apparatus 60 (FIG. 3B). Thereafter, the user can remove the prosthetic valve delivery apparatus 60 from the patient 10 (FIG. 4A), as well as the guide catheter 30 (FIG. 4B).

[0118] FIG. 2A depicts a first stage in a mitral valve replacement procedure, according to one example. As shown, the guide catheter 30 and a guidewire 40 can be inserted into a vasculature 12 of a patient 10 and navigated through the vasculature 12, into a heart 14 of the patient 10, and toward the native mitral valve 16 (e.g., through heart tissue wall between right atrium RA to left atrium LA as shown). Together, the guide catheter 30 and the guidewire 40 can provide a path for the docking device delivery apparatus 50 and the prosthetic valve delivery apparatus 60 to be navigated through and along, to the implantation site (for example, the native mitral valve 16 or native mitral valve annulus).

[0119] Initially, the user may first make an incision in the patient’s body to access the vasculature 12. For example, as illustrated in FIG. 1, the user may make an incision in the patient’s groin to access a femoral vein. Thus, in such examples, the vasculature 12 may include a femoral vein.

[0120] After making the incision to access the vasculature 12, the user may insert the guide catheter 30, the guidewire 40, and / or additional devices (such as an introducer device orDocket No.: TMTTM3-24264WO01transseptal puncture device) through the incision and into the vasculature 12. The guide catheter 30 (which can also be referred to as an “introducer device,’’ “introducer,’’ or “guide sheath”) can be configured to facilitate the percutaneous introduction of various implant delivery devices (for example, the docking device delivery apparatus 50 and the prosthetic valve delivery apparatus 60) into and through the vasculature 12 and may extend through the vasculature 12 and into the heart 14 but may stop short of the native mitral valve 16. The guide catheter 30 can comprise a handle 32 and a shaft 34 extending distally from the handle 32. The shaft 34 can extend through the vasculature 12 and into the heart 14 while the handle 32 can remain outside the body of the patient 10 and can be operated by the user to manipulate the shaft 34 (FIG. 2A).

[0121] The guidewire 40 can be configured to guide the delivery apparatuses (for example, the guide catheter 30, the docking device delivery apparatus 50, the prosthetic valve delivery apparatus 60, additional catheters, or the like) and their associated devices (for example, docking device, prosthetic heart valve, and the like) to the implantation site within the heart 14, and thus may extend all the way through the vasculature 12 and into a left atrium 18 of the heart 14 (and in some examples, through the native mitral valve 16 and into a left ventricle 26 of the heart 14) (FIG. 2A).

[0122] In some instances, a transseptal puncture device or catheter can be used to initially access the left atrium 18, prior to inserting the guidewire 40 and the guide catheter 30. For example, after making the incision to access the vasculature 12, the user may insert a transseptal puncture device through the incision and into the vasculature 12. The user may guide the transseptal puncture device through the vasculature 12 and into the heart 14 (for example, through the femoral vein and into the right atrium 20). The user can then make a small incision in an atrial septum 22 of the heart 14 to allow access to the left atrium 18 from the right atrium 20. The user can then insert and advance the guidewire 40 through the transseptal puncture device within the vasculature 12 and through the incision in the atrial septum 22 into the left atrium 18. Once the guide wire 40 is positioned within the left atrium 18 and / or the left ventricle 26, the transseptal puncture device can be removed from the patient 10. The user can then insert the guide catheter 30 into the vasculature 12 and advance the guide catheter 30 into the left atrium 18 over the guidewire 40 (FIG. 2A).

[0123] In some instances, an introducer device can be inserted through a lumen of the guide catheter 30 prior to inserting the guide catheter 30 into the vasculature 12. In some instances, the introducer device can include a tapered end that extends out a distal tip of the guide catheterDocket No.: TMTTM3-24264WO0130 and that is configured to guide the guide catheter 30 into the left atrium 18 over the guidewire 40. Additionally, in some instances the introducer device can include a proximal end portion that extends out a proximal end of the guide catheter 30. Once the guide catheter 30 reaches the left atrium 18, the user can remove the introducer device from inside the guide catheter 30 and the patient 10. Thus, only the guide catheter 30 and the guidewire 40 remain inside the patient 10. The guide catheter 30 is then in position to receive an implant delivery apparatus and help guide it to the left atrium 18, as described further below.

[0124] FIG. 2B depicts a second stage in the exemplary mitral valve replacement procedure where a docking device 52 can be implanted at the native mitral valve 16 of the heart 14 of the patient 10 using a docking device deh very apparatus 50 (which may also be referred to as an “implant catheter,” or a “docking device delivery device,” or simply “delivery apparatus”).

[0125] In general, the docking device delivery apparatus 50 can include a delivery shaft 54 (which may also be referred to as an “outer shaft”), a handle 56, and a pusher assembly 58 (which may also be referred to as a “pusher shaft”). The delivery shaft 54 can be configured to be advanced through the patient’s vasculature 12 and to the implantation site (for example, native mitral valve 16) by the user, and may be configured to retain the docking device 52 in a distal end portion 53 of the delivery shaft 54. In some examples, the distal end portion 53 of the delivery shaft 54 can retain the docking device 52 therein in a substantially straight delivery orientation (also referred to as a “axially-elongate configuration”).

[0126] The handle 56 of the docking device delivery apparatus 50 can be configured to be gripped and / or otherwise held by the user to advance the delivery shaft 54 through the patient’s vasculature 12. Specifically, the handle 56 can be coupled to a proximal end of the delivery shaft 54 and can be configured to remain accessible to the user (for example, outside the body of the patient 10) during the docking device implantation procedure. In this way, the user can advance the delivery shaft 54 through the patient’s vasculature 12 by exerting a force on (for example, pushing) the handle 56. In some examples, the delivery shaft 54 can be configured to carry the pusher assembly 58 and / or the docking device 52 with it as it advances through the patient’s vasculature 12. In this way, the docking device 52 and / or the pusher assembly 58 can advance through the patient’s vasculature 12 in lockstep with the delivery shaft 54 as the user grips the handle 56 and pushes the delivery shaft 54 deeper into the patient’s vasculature 12.

[0127] In some examples, the handle 56 can comprise one or more articulation members 57 that are configured to aid in navigating the delivery shaft 54 through the vasculature 1 . ForDocket No.: TMTTM3-24264WO01example, the one or more articulation members 57 can comprise one or more of knobs, buttons, wheels, and / or other types of physically adjustable control members that are configured to be adjusted by the user to flex, bend, twist, turn, and / or otherwise articulate a distal end portion 53 of the delivery shaft 54 to aid in navigating the delivery shaft 54 through the vasculature 12 and / or within the heart 14.

[0128] The pusher assembly 58 can be configured to deploy and / or implant the docking device 52 at the implantation site (for example, the native mitral valve 16). For example, the pusher assembly 58 can be configured to be adjusted by the user to push the docking device 52 out of the distal end portion 53 of the delivery shaft 54. A pusher shaft of the pusher assembly 58 can extend through the delivery shaft 54 and can be disposed adjacent to the docking device 52 within the delivery shaft 54. In some examples, the docking device 52 can be releasably coupled to the pusher shaft of the pusher assembly 58 via a connection mechanism of the docking device delivery apparatus 50 such that the docking device 52 can be released after being deployed at the native mitral valve 16. Because the docking device 52 is retained by, held, and / or otherwise coupled to the pusher assembly 58, the docking device 52 can advance in lockstep with the pusher assembly 58 through and / or out of the delivery shaft 54.

[0129] In addition to the pusher shaft, in certain instances, the pusher assembly 58 can also include a sleeve shaft. The pusher shaft can be configured to advance the docking device 52 through the delivery shaft 54 and out of the distal end portion 53 of the delivery shaft 54, while the sleeve shaft, when included, can have a distal dock sleeve configured to cover the docking device 52 within the delivery shaft 54 and while pushing the docking device 52 out of the delivery shaft 54 and positioning the docking device 52 at the implantation site. In some examples, the pusher shaft can be covered, at least in part, by the sleeve shaft.

[0130] In some examples, the pusher assembly 58 can comprise a pusher handle that is coupled to the pusher shaft and that is configured to be gripped and pushed by the user to translate the pusher shaft axially relative to the delivery shaft 54 (for example, to push the pusher shaft into and / or out of the distal end portion 53 of the delivery shaft 54). The dock sleeve can be configured to be retracted and / or withdrawn from the docking device 52, after positioning the docking device 52 at the target implantation site. For example, the pusher assembly 58 can include a sleeve handle that is coupled to the sleeve shaft and is configured to be pulled by a user to retract (for example, axially move) the sleeve shaft relative to the pusher shaft, thereby retracting the dock sleeve.Docket No.: TMTTM3-24264WO01

[0131] The pusher assembly 58 can be removably coupled to the docking device 52, and as such can be configured to release, detach, decouple, and / or otherwise disconnect from the docking device 52 once the docking device 52 has been deployed at the target implantation site. As just one example, the pusher assembly 58 may be removably coupled to the docking device 52 via a thread, string, yarn, suture, or other suitable material that is tied or sutured to the docking device 52.

[0132] In some examples, the pusher assembly 58 can include a suture lock assembly (also referred to as a “suture lock’’) that is configured to receive and / or hold the thread or other suitable material that is coupled to the docking device 52 via a suture. The thread or other suitable material that forms the suture can extend from the docking device 52, through the pusher assembly 58, to the suture lock assembly. The suture lock assembly can also be configured to cut the suture to release, detach, decouple, and / or otherwise disconnect the docking device 52 from the pusher assembly 58. For example, the suture lock assembly can comprise a cutting mechanism that is configured to be adjusted by the user to cut the suture.

[0133] Referring again to FIG. 2B, after the guide catheter 30 is positioned within the left atrium 18, the user may insert the docking device delivery apparatus 50 (for example, the delivery shaft 54) into the patient 10 by advancing the delivery shaft 54 of the docking device delivery apparatus 50 through the guide catheter 30 and over the guidewire 40. In some examples, the guidewire 40 can be at least partially retracted away from the left atrium 18 and into the guide catheter 30. The user may then continue to advance the delivery shaft 54 of the docking device delivery apparatus 50 through the vasculature 12 along the guidewire 40 until the delivery shaft 54 reaches the left atrium 18, as illustrated in FIG. 2B. Specifically, the user may advance the delivery shaft 54 of the docking device delivery apparatus 50 by gripping and exerting a force on (for example, pushing) the handle 56 of the docking device delivery apparatus 50 toward the patient 10. While advancing the delivery shaft 54 through the vasculature 12 and the heart 14, the user may adjust the one or more articulation members 57 of the handle 56 to navigate the various turns, corners, constrictions, and / or other obstacles in the vasculature 12 and the heart 14.

[0134] Once the delivery shaft 54 reaches the left atrium 18 and extends out of a distal end of the guide catheter 30, the user can position the distal end portion 53 of the delivery shaft 54 at and / or near the posteromedial commissure of the native mitral valve 16 using the handle 56 (for example, the articulation members 57). The user may then push the docking device 52 outDocket No.: TMTTM3-24264WO01of the distal end portion 53 of the delivery shaft 54 with the shaft of the pusher assembly 58 to deploy and / or implant the docking device 52 within the annulus of the native mitral valve 16.

[0135] In some examples, the docking device 52 may be constructed from, formed of, and / or comprise a shape memory material, and as such, may return to its original, pre-formed shape when it exits the delivery shaft 54 and is no longer constrained by the delivery shaft 54. As one example, the docking device 52 may originally be formed as a coil and thus may wrap around leaflets 24 of the native mitral valve 16 as it exits the delivery shaft 54 and returns to its original coiled configuration.

[0136] After pushing a ventricular portion of the docking device 52 (for example, the portion of the docking device 52 shown in FIG. 2B that is configured to be positioned within a left ventricle 26 and / or on the ventricular side of the native mitral valve 16), the user may then deploy the remaining portion of the docking device 52 (for example, an atrial portion of the docking device 52 having the brim feature) from the delivery shaft 54 within the left atrium 18 by retracting the delivery shaft 54 away from the medial commissure of the native mitral valve 16. For example, the user can maintain the position of the pusher assembly 58 (for example, by exerting a holding and / or pushing force on the pusher shaft) while retracting the delivery shaft 54 proximally so that the delivery shaft 54 withdraws and / or otherwise retracts relative to the docking device 52 and the pusher assembly 58. In this way, the pusher assembly 58 can hold the docking device 52 in place while the user retracts the delivery shaft 54, thereby releasing the docking device 52 from the delivery shaft 54. In some examples, the user can also remove the dock sleeve from the docking device 52, for example, by retracting the sleeve shaft. The brim feature that is described in more detail below can help facilitate retention of the docking device in the native mitral valve 16.

[0137] After deploying and implanting the docking device 52 at the native mitral valve 16, the user may disconnect the docking device delivery apparatus 50 from the docking device 52. Once the docking device 52 is disconnected from the docking device delivery apparatus 50 (for example, by cutting the suture tied to the docking device 52), the user may retract the docking device delivery apparatus 50 out of the vasculature 12 and away from the patient 10 so that the user can deliver and implant a prosthetic heart valve 62 within the implanted docking device 52 at the native mitral valve 16.

[0138] FIG. 3A depicts a third stage in the mitral valve replacement procedure, where the docking device 52 has been fully deployed and implanted at the native mitral valve 16 and theDocket No.: TMTTM3-24264WO01docking device delivery apparatus 50 (including the delivery shaft 54) has been removed from the patient 10 such that only the guidewire 40 and the guide catheter 30 remain inside the patient 10. In some examples, after removing the docking device delivery apparatus, the guidewire 40 can be advanced out of the guide catheter 30, through the implanted docking device 52 at the native mitral valve 16, and into the left ventricle 26 (FIG. 2B). As such, the guidewire 40 can help to guide the prosthetic valve delivery apparatus 60 through the annulus of the native mitral valve 16 and at least partially into the left ventricle 26.

[0139] As illustrated in FIG. 3A, the docking device 52 can comprise a plurality of helical turns that wrap around the leaflets 24 of the native mitral valve 16 (within the left ventricle 26). The implanted docking device 52 can have a more cylindrical shape than the annulus of the native mitral valve 16, thereby providing a geometry that more closely matches the shape or profile of the PHV to be implanted. As a result, the docking device 52 with the brim feature can provide a tighter fit, and thus a better seal, between the prosthetic heart valve and the native mitral valve 16, as described further below.

[0140] FIG. 3B depicts a fourth stage in the mitral valve replacement procedure where the user is delivering and / or implanting a prosthetic heart valve 62 within the docking device 52 using a prosthetic valve delivery apparatus 60.

[0141] As shown in FIG. 3B, the prosthetic valve delivery apparatus 60 can comprise a delivery shaft 64 and a handle 66. The delivery shaft 64 can extend distally from the handle 66. The delivery shaft 64 can be configured to extend into the patient’s vasculature 12 to deliver, implant, expand, and / or otherwise deploy the prosthetic heart valve 62 within the docking device 52 at the native mitral valve 16. The handle 66 can be configured to be gripped and / or otherwise held by the user to advance the delivery shaft 64 through the patient’ s vasculature 12.

[0142] In some examples, the handle 66 can comprise one or more articulation members 68 that are configured to aid in navigating the delivery shaft 64 through the vasculature 12 and the heart 14. Specifically, the articulation members 68 can comprise one or more of knobs, buttons, wheels, and / or other types of physically adjustable control members that are configured to be adjusted by the user to flex, bend, twist, turn, and / or otherwise articulate a distal end portion of the delivery shaft 64 to aid in navigating the delivery shaft 64 through the vasculature 12 and into the left atrium 18 and left ventricle 26 of the heart 14.Docket No.: TMTTM3-24264WO01

[0143] In some examples, the prosthetic valve delivery apparatus 60 can include an expansion mechanism 65 that is configured to radially expand and deploy the prosthetic heart valve 62 at the implantation site. In some instances, as shown in FIG. 3B, the expansion mechanism 65 can comprise an inflatable balloon that is configured to be inflated to radially expand the prosthetic heart valve 62 within the docking device 52. The inflatable balloon can be coupled to the distal end portion of the delivery shaft 64.

[0144] In other examples, the prosthetic heart valve 62 can be self-expanding and can be configured to radially expand on its own upon removable of a sheath or capsule covering the radially compressed prosthetic heart valve 62 on the distal end portion of the delivery shaft 64. In still other examples, the prosthetic heart valve 62 can be mechanically expandable and the prosthetic valve delivery apparatus 60 can include one or more mechanical actuators (for example, the expansion mechanism) configured to radially expand the prosthetic heart valve 62.

[0145] As shown in FIG. 2D, the prosthetic heart valve 62 can be mounted around the expansion mechanism 65 (for example, the inflatable balloon) on the distal end portion of the delivery shaft 64, in a radially compressed configuration.

[0146] To navigate the distal end portion of the delivery shaft 64 to the implantation site, the user can insert the prosthetic valve delivery apparatus 60 (for example, the delivery shaft 64) into the patient 10 through the guide catheter 30 and over the guidewire 40. The user can continue to advance the prosthetic valve delivery apparatus 60 along the guidewire 40 (for example, through the vasculature 12) until the distal end portion of the delivery shaft 64 reaches the native mitral valve 16, as illustrated in FIG. 2D. More specifically, the user can advance the delivery shaft 64 of the prosthetic valve delivery apparatus 60 by gripping and exerting a force on (for example, pushing) the handle 66. While advancing the delivery shaft 64 through the vasculature 12 and the heart 14, the user can adjust the one or more articulation members 68 of the handle 66 to navigate the various turns, comers, constrictions, and / or other obstacles in the vasculature 12 and heart 14.

[0147] The user can advance the delivery shaft 64 along the guidewire 40 until the radially compressed prosthetic heart valve 62 mounted around the distal end portion of the delivery shaft 64 is positioned within the docking device 52 and the native mitral valve 16. In some examples, as shown in FIG. 2D, a distal end of the delivery shaft 64 and a least a portion of the radially compressed prosthetic heart valve 62 can be positioned within the left ventricle 26.Docket No.: TMTTM3-24264WO01

[0148] Once the radially compressed prosthetic heart valve 62 is appropriately positioned within the docking device 52 (FIG. 3B), the user can manipulate one or more actuation mechanisms of the handle 66 of the prosthetic valve delivery apparatus 60 to actuate the expansion mechanism 65 (for example, inflate the inflatable balloon), thereby radially expanding the prosthetic heart valve 62 within the docking device 52. In some examples, the user can lock the prosthetic heart valve 62 in its fully expanded position (for example, with a locking mechanism) to prevent the prosthetic heart valve 62 from collapsing.

[0149] FIG. 4A shows a fifth stage in the mitral valve replacement procedure where the prosthetic heart valve 62 in its radially expanded configuration and implanted within the docking device 52 in the native mitral valve 16. As shown in FIG. 4A, the prosthetic heart valve 62 can be received and retained within the docking device 52.

[0150] As also shown in FIG. 4A, after the prosthetic heart valve 62 has been fully deployed and implanted within the docking device 52 at the native mitral valve 16, the prosthetic valve delivery apparatus 60 (including the delivery shaft 64) can be removed from the patient 10 such that only the guidewire 40 and the guide catheter 30 remain inside the patient 10.

[0151] FIG. 4B depicts a sixth stage in the mitral valve replacement procedure, where the guidewire 40 and the guide catheter 30 have been removed from the patient 10. The docking device 52 with the brim feature can be configured to provide a seal between the prosthetic heart valve 62 and the leaflets 24 of the native mitral valve 16 to reduce paravalvular leakage around the prosthetic heart valve 62. Specifically, the docking device 52 can initially constrict the leaflets 24 of the native mitral valve 16, where the brim feature sits on top on the left atrial side. The prosthetic heart valve 62 can then push the leaflets 24 against the docking device 52 as it radially expands within the docking device 52. Thus, the docking device 52 and the prosthetic heart valve 62 can be configured to sandwich the leaflets 24 of the native mitral valve 16 when the prosthetic heart valve 62 is expanded within the docking device 52. In this way, the docking device 52 can provide a seal between the leaflets 24 of the native mitral valve 16 and the prosthetic heart valve 62 to reduce paravalvular leakage around the prosthetic heart valve 62.

[0152] In some examples, one or more of the docking device delivery apparatus 50, the prosthetic valve delivery apparatus 60, and / or the guide catheter 30 can comprise one or more fluid ports that are configured to supply flushing fluid to the lumens thereof to prevent and / or reduce the likelihood of blood clot (for example, thrombus) formation. Example fluid ports thatDocket No.: TMTTM3-24264WO01can be used to inject flushing fluid into a docking device delivery apparatus are described further below.

[0153] Although FIGS. 2A-4B specifically depict a mitral valve replacement procedure, however, the same and / or similar procedure may be utilized to replace other heart valves (for example, tricuspid, pulmonary, and / or aortic valves). Further, the same and / or similar delivery apparatuses (for example, docking device delivery apparatus 50, prosthetic valve delivery apparatus 60, guide catheter 30, and / or guidewire 40), docking devices (for example, docking device 52), replacement heart valves (for example, prosthetic heart valve 62), and / or components thereof may be utilized for replacing these other heart valves.

[0154] For example, when replacing a native tricuspid valve, the user may also access the right atrium 20 via a femoral vein but may not need to cross the atrial septum 22 into the left atrium 18. Instead, the user may leave the guidewire 40 in the right atrium 20 and perform the same and / or similar docking device implantation process at the tricuspid valve. Specifically, the user may push the docking device 52 out of the delivery shaft 54 around the ventricular side of the tricuspid valve leaflets, release the remaining portion of the docking device 52 from the delivery shaft 54 within the right atrium 20, and then remove the delivery shaft 54 of the docking device delivery apparatus 50 from the patient 10. The user may then advance the guidewire 40 through the tricuspid valve into the right ventricle and perform the same and / or similar prosthetic heart valve implantation process at the tricuspid valve, within the docking device 52. Specifically, the user may advance the delivery shaft 64 of the prosthetic valve delivery apparatus 60 through the patient’s vasculature along the guidewire 40 until the prosthetic heart valve 62 is positioned or disposed within the docking device 52 and the tricuspid valve. The user may then expand the prosthetic heart valve 62 within the docking device 52 before removing the prosthetic valve delivery apparatus 60 from the patient 10. In another example, the user may perform the same and / or similar process to replace the aortic valve but may access the aortic valve from the outflow side of the aortic valve via a femoral artery.

[0155] Further, although FIGS. 2A-4B depict a mitral valve replacement procedure that accesses the native mitral valve 16 from the left atrium 18 via the right atrium 20 and femoral vein. The native mitral valve 16 may alternatively be accessed from the left ventricle 26. For example, the user may access the native mitral valve 16 from the left ventricle 26 via the aortic valve by advancing one or more delivery apparatuses through an artery to the aortic valve, and then through the aortic valve into the left ventricle 26.Docket No.: TMTTM3-24264WO01

[0156] Additional examples of the docking device delivery apparatus, including its variants, and methods of implanting a docking device and implanting a prosthetic valve within the docking device are described in International Publication Nos. WO 2020 / 247907 and WO 2022 / 087336, and U.S. Patent Publication Nos. US2018 / 0318079, US2018 / 0263764, and US2018 / 0177594, which are all incorporated by reference herein in their entireties.Exemplary Prosthetic Valves

[0157] Details regarding the prosthetic heart valves described herein and various valve components are described U.S. Patent No. 11,185,406, which is incoiporated herein by reference. Additional example prosthetic valves are described in International Patent Application Publication No. WO 2018 / 222799, U.S. Patent No. 9,155,619, and U.S. Patent No.11 ,096,781 , all of which are incorporated herein by reference in their entireties.

[0158] In some examples, the prosthetic heart valves comprise a plastically expandable material, which can be metal alloys, polymers, or combinations thereof. Example metal alloys can comprise one or more of the following: nickel, cobalt, chromium, molybdenum, titanium, or other biocompatible metal. In some examples, the prosthetic heart valve can comprise stainless steel, cobalt-chromium, nickel-cobalt-chromium, a nickel-cobalt-chromium-molybdenum alloy, such as MP35N™ (tradename of SPS Technologies), which is equivalent to UNS R30035 (covered by ASTM F562-02). MP35N™ / UNS R30035 comprises 35% nickel, 35% cobalt, 20% chromium, and 10% molybdenum, by weight.

[0159] In some examples, the prosthetic heart valve can be a self-expandable prosthetic valve with a frame made from a self-expanding material, such as nickel-titanium alloy or Nitinol. When the prosthetic valve is a self-expanding valve, the balloon of the delivery apparatus can be replaced with a sheath or similar restraining device that retains the prosthetic valve in a radially compressed state for delivery through the body. When the prosthetic valve is at the implantation location, the prosthetic valve can be released from the sheath and therefore allowed to expand to its functional size. Any of the delivery apparatuses disclosed herein can be adapted for use with a self-expanding valve.Overview of Docking Devices

[0160] The disclosed docking devices can, for example, provide a stable anchoring site, landing zone, or implantation zone at the implant site in which prosthetic valves can be expanded or otherwise implanted. Many of the disclosed docking devices comprise a circular or cylindrically-shaped portion, which can (for example) allow a prosthetic heart valveDocket No.: TMTTM3-24264WO01comprising a circular or cylindrically-shaped valve frame to be expanded or otherwise implanted into native locations with naturally circular cross-sectional profiles and / or in native locations with naturally with non-circular cross sections. In addition to providing an anchoring site for the prosthetic valve, the docking devices can be sized and shaped to cinch or draw the native valve (for example, mitral, tricuspid, etc.) anatomy radially inwards. In this manner, one of the main causes of valve regurgitation (for example, functional mitral regurgitation), specifically enlargement of the heart (for example, enlargement of the left ventricle, etc.) and / or valve annulus, and consequent stretching out of the native valve (for example, mitral, etc.) annulus, can be at least partially offset or counteracted. Some examples of the docking devices further include features which, for example, are shaped and / or modified to better hold a position or shape of the docking device during and / or after expansion of a prosthetic valve therein. By providing such docking devices, replacement valves can be more securely implanted and held at various valve annuluses, including at the mitral valve annulus which does not have a naturally circular cross-section.

[0161] In some instances, a docking device can comprise a paravalvular leakage (PVL) guard (also referred to herein as “a guard member”). The PVL guard can, for example, help reduce regurgitation and / or promote tissue ingrowth between the native tissue and the docking device.

[0162] The PVL guard can, in some examples, be movable between a delivery orientation (or radially compressed state) and a deployed orientation (or radially expanded state). When the PVL guard is in the delivery orientation, the PVL guard can extend along and adjacent the coil. When the PVL guard is in the deployed orientation, the PVL guard can rotate about a central longitudinal axis of the coil and extend radially outwardly from the coil.

[0163] In some examples, implanting a prosthetic valve at a native annulus involves a two-step implementation procedure including first implanting a docking device, followed by deployment of the prosthetic valve within the docking device. In the transient stage of the procedure (following docking device implant and before the prosthetic valve has been implanted) the docking device must remain stable within the intended implant location before deployment of the prosthetic valve permanently anchors the implants. It is desirable to improve safety and ease of deployment of the docking device.Exemplary Docking Devices

[0164] FIGS. 5-6 depict coils of docking devices according to some examples. In some examples, any of the docking devices herein can comprise a coil, for example coil 102 (FIG.Docket No.: TMTTM3-24264WO015) or coil 202 (FIG. 6), in use with a guard member. In some examples, the guard member can comprise a braided sleeve as described in International Publication No. WO2022 / 087336 which is incorporated by reference herein in its entirety. Additional examples of guard members and other components of docking devices are described in International Application No. WO / 2024 / 37038 and in Applicant Docket No. THVMC-23455US02, which are incorporated by reference herein. In some examples, the guard member can comprise any of the guard members described herein. An example of a docking device 300 comprising a guard member 304 attached to a coil 302 can be seen in FIG. 7, similar guard members can be used with any of the coils disclosed herein.

[0165] FIG. 5 depicts a docking device 100 which comprises a coil 102 with an inflow side 160 and an outflow side 170. In some examples, the docking device 100 can further comprise a guard member as shown elsewhere herein. The docking device 100 can be configured to fit at the mitral position but can be shaped and / or adapted similarly or differently in other examples for better accommodation at other native valve positions as well, such as at the tricuspid valve. Docking device geometries disclosed herein may provide for engagement with the native anatomy that can provide for increased stability and reduction of relative motion between the docking device, the prosthetic valve docked therein, and the native anatomy (which is moving during and after the implantation procedure). Reduction of such relative motion can, for example, prevent material degradation of components of the docking device and / or the prosthetic valve docked therein and can prevent damage / trauma to the native tissues as well as preventing PVL.

[0166] The coil 102 can include a central region 108 with a turn, coiled portion, or multiple turns (e.g., 2 turns, 3 turns, 4 turns, between 2-5 turns, or more). The turns of the central region 108 can be similarly sized and shaped or vary in size and / or shape. In some examples, the central region 108 comprises three or approximately three full coil turns having substantially equal inner diameters. The central region 108 of the coil 102 serves as the main landing region or holding region for holding the expandable prosthetic valve when the coil 102 and the valve prosthesis are implanted into a patient’s body. In some examples, the coil 102 has a central region 108 with more or less than three coil turns, depending for example, on the patient’s anatomy, the amount of vertical contact desired between the coil 102 and the valve prosthesis (e.g., transcatheter heart valve or THV), and / or other factors. The coiled portion or tum(s) of the central region 108 can also be referred to as the “functional coils’’ or “functional turns” since the properties of these turns contribute the most to the amount ofDocket No.: TMTTM3-24264WO01retention force generated between the valve prosthesis, the coil 102, and the native mitral leaflets and / or other anatomical structures.

[0167] In examples where the docking device 100 is used at the mitral position, the docking device can first be advanced and delivered to the native mitral valve annulus, and then set at a desired position, prior to implantation of the prosthetic heart valve. In some examples, the coil 102 is flexible and / or made of a shape memory material, so that the coils can be straightened for delivery via a transcatheter approach as well. In some examples, the coil 102 can be made of another biocompatible material, such as stainless steel. Some of the same catheters and other delivery tools can be used for both delivery of the docking device 100 and the prosthetic valve, without having to perform separate preparatory steps, simplifying the implantation procedure for the end user.

[0168] Since the functional coils / turns or coils / tums of the central region 108 of the coil 102 are kept relatively small in diameter (e.g., the central region 108 in one example can have an inner diameter of between approximately 21-24 mm (e.g., ± 2 mm) or another diameter smaller than the prosthetic valve and / or the native annulus) in order to increase retention force with the prosthetic valve, it might be difficult to advance the docking device 100 around the existing leaflets and / or chordae tendineae to a desired position relative to the native mitral annulus. This is especially true if the entire docking device 100 is made to have the same small diameter as the central region 108. Therefore, the coil 102 can have a distal or lower region that comprises a leading turn 106 (sometimes referred to as an encircling turn or a leading ventricular coil / turn) of the coil 102, which has a lower diameter that is greater than the diameter of the functional coils / turns or of the coils / turns of central region 108.

[0169] Features of the native anatomy, especially in the right and left ventricles, have variable dimensions. For example, native mitral anatomy can have an approximately 25 mm to 65 mm greatest width on a long axis. The diameter or width of the encircling turn or leading turn 106 (e.g., ventricular coil / turn) can be selected to be larger to more easily navigate a distal or leading tip portion 107 of the docking device 100 around and encircle the features of the native anatomy (e.g., leaflets and / or chordae tendineae).

[0170] As used herein, the turns of the coil are referred to as defining a lumen diameter and / or as being disposed in a plane that is normal to the longitudinal axis 101 which extends through a central lumen 120. Because the turns of the coil form a spiral, they do not necessarily define a traditional diameter or plane. The plane referred to herein should beDocket No.: TMTTM3-24264WO01understood to be a plane that bisects the referenced turn of the coil in at a midpoint along the longitudinal axis. In other words, a given turn of the coil will be half above and half below the plane that it is said to be disposed in.

[0171] A diameter of a given turn of the coil as referred to herein lies in a plane as described above. As mentioned above, the term “diameter” as used in this disclosure does not require that a turn be a complete or perfectly shaped circle but is generally used to refer to a greatest width across opposing points of the coil / tum. For example, with respect to the leading coil / turn, diameter can be measured from the distal tip portion 107 to the opposite side, as if the lower region or leading turn 106 formed a complete rotation. Various sizes and shapes are possible, for example, the diameter could be any size from 25 mm to 75 mm.

[0172] In various examples, the docking device 100 can also include an enlarged proximal or upper region that comprises a stabilization turn 110 (e.g., which can be an atrial coil / tum) of the docking device 100. During a transient or intermediate stage of the implantation procedure, the docking device is released from the delivery apparatus but not yet fully secured relative to the native anatomy by the prosthetic heart valve. The docking devices disclosed herein can, for example, improve stability and / or reduce movement of the docking device during the transient stage. In some examples, a stabilization feature or coil can be used to help stabilize the docking device in the desired position. In some examples, the stabilization turn 110 can be configured to abut or push against the walls of the circulatory system (e.g., against the walls of the left atrium), in order to improve the ability of the docking device 100 to stay in its desired position prior to the implantation of the prosthetic valve.

[0173] In some examples, the stabilization turn 110 can have an atrial portion 110c in connection with the central region 108, a stabilization portion 110a adjacent to the proximal end 112 of the coil 102, and an ascending portion 110b located between the atrial portion 110c and the stabilization portion 110a. Both the atrial portion 110c and the stabilization portion 110a can be generally parallel to the helical turns in the central region 108, whereas the ascending portion 110b can be oriented to be angular relative to the atrial portion 110c and the stabilization portion 110a. For example, in certain examples, the ascending portion 110b and the stabilization portion 110a can form an angle from 45 degrees to about 90 degrees (inclusive). When implanting the docking device 100 at the native mitral valve location, the atrial portion 110c can be configured to abut against a posterior wall of the leftDocket No.: TMTTM3-24264WO01atrium and the stabilization portion 110a can be configured to flare out and press against an anterior wall of the left atrium, along with the guard member.

[0174] The stabilization turn 110 (e.g., atrial coil / turn) of the docking device 100 in the example shown can extend up to about one full turn or rotation, and terminates at a proximal tip portion 112. In other examples, the stabilization coil / turn (e.g., atrial coil) can extend for more or less than one turn or rotation, depending for example on the amount of contact desired between the docking device and the circulatory system (e.g., with the walls of the left atrium) in each particular application. The radial size of the stabilization turn 110 can also be significantly larger than the size of the functional coils in the central region 108, so that the stabilization coil / turn (e.g., atrial coil or atrial turn) flares or extends sufficiently outwardly in order to contact the walls of the circulatory system (e.g., the walls of the left atrium).Additionally, the stabilization coil / turn of various examples will be configured to be less abrasive to the native tissue and / or anatomy. For example, the surface texture can be made smoother and / or softer, such that movement of the docking device against the native anatomy will not damage the native tissue.

[0175] FIG. 6 depicts a docking device 200 comprising a coil 202. In some examples, the docking device 200 is similar to the docking device 100 except for the differences described below. For example, the docking device 200 can comprise an inflow side 260 and an outflow side 270 and can include a stabilization turn 210 (also referred to as a “stabilization coil” or a “first coil region”), a central region 208 (also referred to as “functional turns” or a “second coil region”), and a leading turn 206 (or “leading coil”), each of which are disposed around a longitudinal axis 201 which extends through a central lumen 220, etc. some components may not be repeated here for sake of brevity. However, the docking device 200 need not include all of the components described above for the docking device 100. For example, the docking device 200 may omit the ascending portion 110b and the raised stabilization portion 110a. Omitting these portions may reduce required materials, eliminate procedural steps, and in some examples, can make deployment easier. Omitting the ascending portion 110b and the raised stabilization portion 110a also allows for additional attachment surface for a guard member along the stabilization turn 210 and can lead to increased stability of the docking device once it is disposed in the anatomy.

[0176] In some examples, when implanting the docking device at the native mitral valve location, functional turns in a central region 208 can be disposed substantially in the left ventricle and the stabilization turn 210 can be disposed substantially in the left atrium. TheDocket No.: TMTTM3-24264WO01stabilization turn 210 can be configured to provide increased stability and improved sealing. In some examples, the points of contact between a docking device comprising the coil 202 and the left atrial wall can form a plane that is approximately parallel to a plane of the native mitral valve. In some examples, a guard member can be used with the stabilization turn 210 and configured to provide increased stability to the docking device as it is positioned in the mitral valve.

[0177] In the depicted example, an attachment portion 212 is disposed at a proximal end portion of the stabilization turn 210 and can be lifted the axial direction. This attachment portion terminates in a proximal end 213. The upward flare of the proximal end portion 212 can be define an angle 214 which is formed with a plane defined by the helical turns in the central region 208. In some examples, the angle 214 can comprise and angle greater than 5-degrees but less than 90 degrees. In some examples, the angle 214 can comprise and angle greater than 15-degrees but less than 45-degrees. In some examples, the angle 214 can comprise and angle greater than 20 degrees but less than 40-degrees. In some examples, the angle 214 is 30 degrees. The proximal end 213 does not extend more than 12 mm in the axially proximal direction from the stabilization turn, that is the proximal end portion does not extend more than 12 mm in an axial direction from a plane defined by the stabilization turn 210 that is orthogonal to the longitudinal axis and 201.

[0178] The attachment portion 212 can be configured to releasably couple the coil 202 to a delivery apparatus (for example, docking device delivery apparatus 50). The upward flare of the proximal end portion 212 can be advantageous in coupling the coil 202 to the delivery apparatus, for example by helping to ensure that the attachment portion 212 is not obstructed (i.e. by the guard member) and helps to ensure easier access to the attachment portion 212. In some examples, as discussed above, the coil 202 can be coupled to the delivery apparatus via a release suture that can be configured to be tied to the coil 202 and cut for removal. In one example, the release suture can be tied to the coil 202 through one or more eyelets or eyeholes located at the attachment portion 212 of the coil 202. In some examples, the release suture can be tied around a circumferential recess that is located adjacent the attachment portion 212 of the coil 202.

[0179] The central region 208 can comprise one or more helical turns having substantially equal lumen diameters. The leading turn 206 can extend from a distal end of the central region 208 and, in some examples, can have a lumen diameter substantially equal to the lumen diameter of the central region 208. In some examples, the leading turn can comprise aDocket No.: TMTTM3-24264WO01distal end portion 207 that extends radially outward. In some examples, the stabilization turn 210 can extend from a proximal end of the central region 208 and can have a lumen diameter substantially equal to the lumen diameter of the central region 208. In some examples, the lumen diameter of the stabilization turn can be different than the lumen diameter of the central region 208.

[0180] In some examples, when implanting the docking device 200 at the native mitral valve location, the functional turns in the central region 208 can be disposed substantially in the left ventricle and the stabilization turn 110 can be disposed substantially in the left atrium. The stabilization turn 210 can be configured to provide one or more points or regions of contact between the docking device 200 and the left atrial wall adjacent to the mitral valve, such as at least three points of contact in the left atrium or complete contact on mitral anulus. In some examples, the points of contact between the docking device 200 and the left atrial wall can form a plane that is approximately parallel to a plane of the native mitral valve. In some examples, the contact between the stabilization turn 210 and the atrial wall can be through an intermediary, such as a guard member.

[0181] FIG. 7 depicts a docking device 300 comprising a coil 302 with a guard member 304 attached. In some examples, the docking device 300 may have some or all of the features described above with respect to the other docking devices described herein, for example either the docking device 100 and / or the docking device 200. For example, the docking device 300 can comprise an inflow side 360 and an outflow side 370 and include can include a stabilization turn 310 (also referred to as a “stabilization coil” or a “first coil region”), a central region 308 (also referred to as “functional turns” or a “second coil region”), and a leading turn 306 (or “leading coil”), each of which are disposed around a longitudinal axis which extends through a central lumen 320, etc. some components may not be repeated here for sake of brevity. However, the docking device 300 need not include all of the components described above for the docking device 100 or docking device 200. In some examples, the docking device 300 may omit the ascending portion 310b and the raised stabilization portion 310a. Omitting these portions may reduce required materials, eliminate procedural steps, and in some examples, can make deployment easier.

[0182] In some examples, the guard member 304 may have some or all of the features described with respect to the other guard members described herein, for example the guard member 304 may comprise a scaffold and a flap. The scaffold can comprise a spine, a plurality of arms extending radially outward from the spine, and one or more terminal lobes.Docket No.: TMTTM3-24264WO01The scaffold can be fitted with a flap 340 which can be sized or adapted to fit over the scaffold to form the guard member 304. The flap 340 can comprise sleeves 342 which cover the arms of the scaffold. The flap 340 may also cover a medial terminal lobe 344 (also referred to as a “first terminal lobe”) and a lateral terminal lobe 346 (also referred to as a “second terminal lobe”). In some examples, the flap sheet is folded over the ends of the arms to provide increased protection to native tissue.

[0183] As mentioned above, the guard member can be attached to the coil to form the docking device. In some examples, the guard member can be coupled to a portion of the coil configured to be disposed substantially in the left atrium. For example, the guard member can be attached to the atrial portion 310c of the stabilization turn 310. The guard member can be attached to the inflow side of the stabilization turn and / or the outflow side of the stabilization turn. In some examples, the guard member has a portion attached to the outflow side of the stabilization turn and transitions or wraps around to the inflow side of the stabilization turn. The flap and / or the scaffold of the guard member can be attached to the coil via one or more sutures, loop stiches, wraps, or other fastening feature. In some examples, the spine and coil core may be directly bonded together (e.g., adhesive, welding, brazing, etc.), or placed adjacent and wrapped together with a wrapping cover. The guard member can be configured to provide increased stability and improved sealing.

[0184] In some examples, the guard member 304 may extend out of a plane defined by the stabilization turn 310 by an angle 350. Tn some examples, the angle 350 is in a range of 0 to 90 degrees, a range of 15 to 60 degrees, or a range of 20 to 40 degrees. In some examples the angle 350 is 30 degrees. As will be described below, in some examples, as a prosthetic valve frame is expanded within the docking device 300, the coil expands outwardly, including the atrial portion 310c of the stabilization turn. As the atrial portion of the stabilization turn expands outwardly, the spine of the scaffold that forms the guard member 304 also expands radially outward. As the spine of the scaffold that forms the guard member 304 expands radially outward the guard member angle 350 may change.

[0185] FIG. 8 shows an example of a scaffold 400 which can be used as a part of a guard member, such as guard member 304 described above. The scaffold 400 can comprise a spine 410 (also referred to as a “curved spine”), a plurality of arms 414 and two terminal lobes, a medial terminal lobe 406 and a lateral terminal lobe 408. The medial terminal lobe 406 may be disposed at a first end portion of the spine 410 and the lateral terminal lobe may be disposed at a second end portion of the spine 410. Scaffold 400 is depicted as generally flatDocket No.: TMTTM3-24264WO01and / or planar. For example, spine 410, anus 414 and lobes 406, 408, as depicted all define a plane, or lie in a plane, and do not generally extend outside of said plane. The spine 410 can be curved such that it defines an arc from the first end portion the second end portion. The scaffold 400 can be fitted with a flap, not shown in FIG. 8 but as described and shown elsewhere herein to form a guard member. The flap can be sized or adapted to fit over the scaffold. Guard members comprising the scaffold 400 can have one or more of the advantages and features described and shown elsewhere herein. For example, guard members comprising the scaffold 400 may reduce PVL.

[0186] In the depicted example, the plurality of arms 414 comprises six arms. The arms 414 have a proximal base portion 414b with an elongate proximal region that turns into a medial curved region with a distal head 414h. The distal head 414h is shown to have an aperture formed therein. However, the distal head 414h may be solid and omit the aperture. The aperture can be favorable to provide for less material and weight of the scaffold 400 while still providing a rounded end to inhibit damaging the cover material of the guard member.

[0187] In some examples one or more of the terminal lobes may comprise an apex. In the example depicted in FIG. 8, the medial terminal lobe 406 comprises a first apex 420, which points in a circumferential direction towards the lateral terminal lobe 408. In some examples, the medial terminal lobe 406 can also comprise a circumferentially extending partial arm 415 which can be coupled to the first apex 420. The circumferentially extending partial arm 415 can comprise a distal head 415h which can have the advantage of a rounded end to inhibit damaging the cover material of the guard member. In some examples, a second apex 422 can be formed where the lateral terminal lobe 408 meets the spine 410.

[0188] In some examples, the scaffold 400 forms a unitary piece. For example, the spine 410 and the arms 414 can be laser cut from a single sheet of metal or metal alloy. In other examples, the arms 414 and the spine 410 can be created as separate components and then joined together (for example, via molding, welding, soldering, etc.) to form the scaffold 400.

[0189] The scaffold 400 can be movable between a delivery orientation (or radially compressed state) and a deployed orientation (or radially expanded state). When the scaffold 400 is in the delivery orientation, the scaffold 400 can extend along and adjacent the coil. When the scaffold 400 is in the deployed orientation, the scaffold 400 can rotate about a central longitudinal axis of the coil and extend radially outwardly from the coil. For example, the arms 414 can be radially compressed or expanded as the scaffold 400 moves between the radiallyDocket No.: TMTTM3-24264WO01compressed state and radially expanded state. The spine 410 can be curved or straightened as the scaffold moves between the curved state and substantially straight state. The spine 410 can also be folded or unfolded as the scaffold moves between the folded configuration and unfolded configuration.

[0190] The scaffold 400 can comprise a shape memory material, such as Nitinol. The scaffold 400 can be shape set so that the scaffold 400 is biased toward the deployed orientation. For example, when the scaffold 400 is retained within a delivery shaft (for example, the delivery shaft 490) of a delivery apparatus during delivery of the docking device and after initial deployment of the docking device at the implantation site, the arms 414 can be radially compressed and the spine 410 can be substantially straightened and folded. After deploying the docking device and removing the dock sleeve from the scaffold 400, the spine 410 can unfold and become curved, and the arms 414 can radially expand under the biasing force.

[0191] FIG. 9 depicts a partial cross section showing a portion of the scaffold 400 in a radially compressed state, for example, in a delivery orientation within a delivery shaft 490 (also referred to as a “delivery catheter”). FIG. 9 only depicts the medial terminal lobe 406 with the first apex 420 and the circumferentially extending partial arm 415 coupled to the first apex 420, but the entire scaffold can be radially compressed in a similar manner. As should be apparent from FIG. 9, the first apex 420 can have the advantage of making the scaffolding easier to compress to fit withing the delivery shaft 490 and reducing strain when a guard member comprising the scaffold 400 is loaded into a delivery catheter.

[0192] FIGS. 10-11 depict different aspects of the scaffold 400 where the scaffold is not entirely flat or planar as briefly described above. In some examples, the scaffold is shape set to bring the scaffold to its final form. In some examples, as depicted in FIG. 10, the spine 410 may be curved into an arc and may define a plane and at least a portion of one or more of the arms 414, the medial terminal lobe 406, and / or the lateral terminal lobe 408 can extend out of the plane defined by the spine 410. The shape given to the scaffold may have advantages, for example, the shape may improve conformity to the left atrium.

[0193] In some examples, as depicted in FIG. 10, the arms 414 may extend out of a plane defined by the spine 410 by an angle 450. In some examples, the angle 450 is in a range of 0 to 90 degrees, a range of 10 to 60 degrees, or a range of 20 to 45 degrees. In some examples the angle 450 is in a range of 20 to 25 degrees before the guard member comprising the scaffold 400 is attached to the stabilization turn. Tn some examples, the angle 450 gets steeperDocket No.: TMTTM3-24264WO01when the guard member comprising the scaffold 400 is attached to a stabilization turn and the spine 410 diameter is pulled in to meet the diameter of the stabilization turn. In some examples, with the scaffold 400 attached to the stabilization turn, the angle 450 can be 30 degrees.

[0194] In some examples, as depicted in FIG. 11 , the lateral terminal lobe, the medial terminal lobe, and the distal end of the medial terminal lobe may extend out of the plane defined by the spine 410. In some examples, the medial terminal lobe may extend out of the plane defined by the spine 410 by an angle 452 and the lateral terminal lobe may extend out of the plane defined by the spine 410 by an angle 454. In some examples, the angle 452 and / or the angle 454 may be in a range of 0 to 90 degrees, a range of 10 to 60 degrees, or a range of 20 to 45 degrees. In some examples the angle 452 and / or the angle 454 may be in a range of 20 to 25 degrees before the guard member comprising the scaffold 400 is attached to the stabilization turn. In some examples, the angle 452 and / or the angle 454 may get steeper as the guard member comprising the scaffold is attached to a stabilization turn and the spine 410 diameter is pulled in to meet the diameter of the stabilization turn. In some examples, with the scaffold 400 attached to the stabilization turn, the angle 452 and / or the angle 454 is 30 degrees. In some examples, the angle 452 and the angle 454 may be equal to one another. In some examples, the angle 452 and the angle 454 may be different from one another. In some examples, the angle 452 and the angle 454 may be shallower than the angle 450. In some examples, the distal end of the medial terminal lobe can be raised up at a different angle, angle 456, to help ensure it does not enter the medial commissure. In some examples, the angle 456 may be greater than the angle 452. In some examples, the angle 456 may be in a range of 0 to 90 degrees, a range of 10 to 60 degrees, or a range of 20 to 45 degrees. In some examples the angle 456 may be 45 degrees.

[0195] FIG. 12 depicts a docking device, for example docking device 300 from FIG. 7. The docking device 300 comprises a coil 302 and a guard member 304. A prosthetic implant is installed within the docking device 300, for example a prosthetic valve frame 390 (the prosthetic valve can be any of the prosthetic valves discussed herein, for example, prosthetic heart valve 62). For purposes of illustration, the valve structure (e.g., leaflets) are not depicted in FIG. 12. The prosthetic valve frame can be configured to be initially inserted into the lumen 320 of the docking device 300 in a radially compresses state (e.g., delivery orientation) and then expanded to a radially expanded state. The central region 308 can be configured to receive and retain a radially expanded prosthetic valve. The size of the coil 302Docket No.: TMTTM3-24264WO01and therefore the lumen 320 can be generally selected based on the size of the desired prosthetic valve to be implanted into the patient. The lumen diameter of the helical turns in the central region 308 can be configured to be smaller than an outer diameter of the prosthetic valve frame 390 such that when the prosthetic valve is radially expanded the functional turns in the central region 308 can be radially expanded. This has the result that radial force can act between the central region 308 and the prosthetic valve to hold the prosthetic valve frame 390 in place.

[0196] With the prosthetic valve frame 390 expanded within the docking device 300, the coil expands outwardly, including the atrial portion 310c of the stabilization turn. As the atrial portion of the stabilization turn expands outwardly, the spine of the scaffold that forms the guard member 304 also expands radially outward. As the spine of the scaffold that forms the guard member 304 expands radially outward the guard member is disposed at a second guard member angle 352. In some examples, the second guard member angle 352 is smaller than the first guard member angle 350 depicted in FIG. 7. This may result in the guard member 304 laying down on the native anatomy as the prosthetic valve frame 390 is deployed. This may have the advantage of creating a better PVL seal between the guard member and the native anatomy.

[0197] In some examples, the deployed prosthetic heart valve has an outer diameter of 29 mm, and the stabilization turn where the brim is attached can be designed with a diameter within a range of 22-28 mm. As the prosthetic heart valve expands the stabilization turn increases to the 29 mm diameter of the prosthetic heart valve the brim will settle down as described above. In some examples, the angle change is in part determined by the diameter change (e.g., the angle on a 26 mm initial stabilization turn diameter would flatten less than that of a 23 mm initial stabilization turn diameter).

[0198] FIG. 13 depicts a scaffold 400', which can be used with a flap to form a guard member, according to another example. In some examples, the scaffold 400' shares features with the scaffold 400. In some examples, the scaffold 400' described below is similar to the scaffold 400, except for the differences described below. However, the scaffold described below need not include all the components described above. In some examples, the scaffold 400' comprises a medial terminal lobe 406 with a first apex 420 and a circumferentially extending partial arm 415 as described above for scaffold 400. In the example depicted in FIG. 13, the scaffold 400' further comprises a lateral terminal lobe 408' with a second apex 422' which points in a circumferential direction towards the medial terminal lobe 406 and aDocket No.: TMTTM3-24264WO01circumferentially extending partial arm 413 which is coupled to the second apex 422'. The circumferentially extending partial arm 413 can comprise a distal head 413h which can have the advantage of a rounded end to inhibit damaging the cover material of the guard member. The scaffold 400' can be used with any of the docking devices described herein, for example as a part of the docking device 300.

[0199] FIGS. 14A-14C depict partial scaffolds 500a, 500b, 500c which can be used with a flap to form a guard member. In some examples, the scaffolds depicted in FIGS. 14A-14C can be similar to the scaffold 400, except for the differences described below. However, the scaffold described below need not include all the components described above. The partial scaffolds depicted include a medial terminal lobe 506 (also referred to as a “first terminal lobe”) and a plurality of arms 514. The plurality of anus 514 can comprise the features described above for the plurality of arms 414 of the scaffold 400. The scaffold described below may provide additional support to the flap. For example, it may be advantageous to reduce the gap from the medial terminal lobe 506 to a first arm 514’ of the plurality of arms 514.

[0200] In some examples, as depicted in FIG. 14A-14B, the plurality of arms 514 may comprise the first arm 514' which is disposed adjacent to the medial terminal lobe 506. The first arm 514' can further comprise a second distal end portion disposed radially outward from the spine and in a second circumferential direction. As depicted in FIG. I4A, the portion 516a can have a first length LI and form a first angle 518a with an elongate proximal region of the first arm 514'. As depicted in FIG. 14B, the portion 516b can have a second length L2 and form second angle 518b with the elongate proximal region of the first arm 514'. Both the portion 516a and the portion 516b can have a head portion 516h with a rounded end to inhibit damaging the cover material of the guard member. As depicted in FIG. 14C, another way to reduce the gap from the medial terminal lobe 506 to a first arm 514' of the plurality of arms 514 is to add an arm 515 which extends circumferentially from the medial terminal lobe 506 is the same direction as the plurality of arms 514.

[0201] In some examples, it may be desirable for a docking device to have an atrial turn with a larger lumen diameter than the lumen diameter of the functional coils. This can provide improved docking device stability in the transient stage of implantation, while maintaining radial retention between the dock and prosthetic heart valve. In order to mitigate potential PVL leak paths between the docking device and the prosthetic heart valve the guard member may comprise a radially inward portion which can be added to the guard member to increaseDocket No.: TMTTM3-24264WO01radial retention with the prosthetic heart valve. Similar to other guard members described herein, a main spine of the scaffolds described below can be attached to the larger diameter atrial turn of the coil of the docking device and the radially inward portion features can protrude radially inwards from the main spine. As the prosthetic heart valve is expanded inside the docking device, the radially inward portion of the guard member has features which can make contact with the frame of the prosthetic heart valve and add additional radial retention forces between the prosthetic heart valve and the atrial portion of the docking device. The radially inward portion of the guard member may also be covered with a covering or flap (e.g., PET, ePTFE, silicone, etc.) to mitigate potential leak paths between the docking device and the frame of the prosthetic heart valve.

[0202] FIG. 15 depicts a docking device 600 which can share features with the docking devices described above, for example the docking device 100 or the docking device 200. In some examples, the docking device 600 is similar to the docking device 100 and / or the docking device 200, except for the differences described below. However, the docking device 600 described below need not include all the components described above. The docking device can comprise a guard member 604 comprising a scaffold which can be fitted with a flap 640 which can be sized or adapted to fit over the scaffold. In some examples, the flap 640 comprises sleeves 642 which cover the arms of the scaffold. In some examples, flap 640 covers a medial terminal lobe 644 and a lateral terminal lobe 646. The docking device 600 defines a lumen 620 and a longitudinal axis 601. The docking device 600 has a stabilization turn 610 with a first lumen diameter 605a which can be larger than a second lumen diameter 605b of the coils in the central region 608, so that the stabilization turn 610 can extend radially outwardly so as to abut or push against the walls of the circulatory system, thereby improving the ability of the docking device 600 to stay in its desired position prior to the implantation of the prosthetic valve. This feature may enhance docking device stability (e.g., in larger anatomies). In some examples, the first lumen diameter 605a is between 5 percent and 50 percent greater than the second lumen diameter 605b. In some examples, the first lumen diameter 605a is between 10 percent and 25 percent greater than the second lumen diameter 605b. In some examples, the first lumen diameter 605a can be between 25 mm and 30 mm and the second lumen diameter 605b can be between 20 mm and 25 mm. In some examples, the second lumen diameter 605b can be 22.7 mm and the first lumen diameter 605a can be 25 mm. In some examples, the second lumen diameter 605b can be 22.7 mm and the first lumen diameter 605a can be 28 mm. This difference between the first lumen 605aDocket No.: TMTTM3-24264WO01diameter and the second lumen diameter 605b can create an opening 630 between the stabilization turn 610 and the coils of the central region 608.

[0203] FIG. 16 depicts a docking device 700 which, in some examples, shares features with the docking devices described above, for example, the docking device 600. In some examples, the docking device 700 is similar to the docking device 600 except for the differences described below. However, the docking device 700 described below need not include all the components described above. The docking device 700 defines a lumen 720 and a longitudinal axis 701 has a stabilization turn 710 with a first lumen diameter 705a which can be larger than a second lumen diameter 705b of the coils in the central region 708. The guard member 704 of the docking device 700 comprises a scaffold and a flap which can be sized or adapted to fit over the scaffold. In some examples, the scaffold can comprise a spine, a plurality of arms extending radially outward from the spine, and one or more terminal lobes. In some examples, the flap 740 comprises sleeves 742 which cover the arms of the scaffold. Tn some examples, flap 740 covers a medial terminal lobe 744 and a lateral terminal lobe 746.

[0204] The guard member 704 can further comprise a radially inward portion 750 which can cover an opening between the stabilization turn 710 and the coils in the central region 708 (not shown), similar to opening 630. The radially inward portion 750 can comprise one or more cells extending radially inward from the main spine, the radially inward portion 750 can be fitted with the flap 740 which can be sized or adapted to fit over the radially inward portion 750.

[0205] FIGS. 17-28 depict examples of scaffolds which comprise a radially inward portion and which may be used as a part of a docking device, for example as a part of docking device 700 depicted in FIG. 16. In some examples, the radially inward portion comprises multiple cells that all share a side with the main spine and protrude radially inward. In some examples, the radially inward portion can comprise a plurality of strut elements, the strut elements may form partial or completed cells. In some examples, the radially inward portion comprises a single cell which is formed by a second spine which is disposed radially inward from the main spine. The radially inward portions can be designed such that they are positioned to provide radial retention once the prosthetic heart valve is in the deployed configuration. In some examples, the radially innermost portion of each cell can be curved to accommodate the circular outer diameter of the prosthetic heart valve.Docket No.: TMTTM3-24264WO01

[0206] In some examples, the prosthetic heart valve may further have an outer skirt comprising of voluminous "float" regions that are connected by small sections of a leno weave pattern. The radially inward portion of the scaffold can mate with this outer skirt such that the float regions are on the top and bottom faces of the radially inward portion of the scaffold, providing an even more robust PVL seal.

[0207] FIGS. 17-23 depict scaffolds which comprise a radially inward portion with a plurality of cells and / or plurality of stmt elements. FIGS. 24-28 depict scaffolds which comprise a radially inward portion which comprises a single cell which is formed by a second spine which is disposed radially inward from the main spine.

[0208] FIGS. 17-18 depict a scaffold 800 which comprises a radially inward portion with a plurality of cells 880. Similar to the other scaffold discussed herein, the scaffold 800 can comprise a main spine 810, a plurality of arms 814, a medial terminal lobe 806, and a lateral terminal lobe 808. In some examples, the medial terminal lobe 806 can comprise a first apex 820 and a circumferentially extending partial arm 815 can be coupled to the first apex 820. The main spine 810 can define an arc, the arc extending between a first end portion (also referred to as a “proximal end”) adjacent to the lateral terminal lobe 808 and a second end portion (also referred to as a “distal end”) adjacent to the medial terminal lobe 806.

[0209] The scaffold 800 as depicted in FIG. 17 comprises five cells 880 (also referred to as “strut elements”). In some examples the scaffold can comprise more than five cells or fewer than five cells. In some examples, the scaffold can comprise three cells or four cells. The cells 880 can be formed by a plurality of struts some of which can have an end coupled to the main spine 810. In some examples the main spine 810 and the struts of the cells 880 are integrally formed, that is, formed from one continuous piece of material. In some examples, the cells can be closed cells which surround an internal opening with stmts on all sides. In other words, a closed cell is continuous and is coupled to the main spine 810 at two circumferentially spaced out points. In some examples, the cell can be coupled to the main spine at two points which can be evenly spaced between the points at which the arms 814 are coupled to the main spine 810. This even spacing may have advantages for reducing strains when the scaffold is compressed to the delivery orientation, for example when being loaded into a delivery catheter.

[0210] In some examples, the cells 880 can be formed from a first stmt 882 (also referred to as a “proximal stmt”), a second stmt 884 (also referred to as an “inner stmt”), a third stmtDocket No.: TMTTM3-24264WO01886 (also referred to as a “distal strut”), and a fourth strut 888 (also referred to as an “outer strut”). In some examples, as depicted, the fourth strut 888 can comprise a portion of the main spine 810. When the guard member is in the deployed configuration, the third strut 886 of each cell may be perpendicular or nearly perpendicular (within five degrees) with the main spine to provide radial retention once the prosthetic heart valve is deployed within the docking device. In some examples, the second strut 884 can be curved to accommodate the circular outer diameter of the prosthetic heart valve. The first strut 882 can be angled outward from the main spine 810, such that the second strut 884 is longer than the fourth strut 888.

[0211] Each cell 880 can be collapsed radially outward towards the main spine 810 to fit inside the sleeve catheter. The connection between the first strut 882 and second strut 884 can create an apex 883. In some examples, the apex 883 can comprise an acute angle towards the inside of the cell, which can have the advantage of reducing strain when the guard member is in the collapsed state. In some examples, the connection between the second strut 884 and the third strut 886 can have a corner 885 which can be softer or more flexible than the second strut 884 and or third strut 886. In some examples, the comer 885 has a thinner wall to reduce strains when straightened in the collapsed state. The cell 880 can have a first length DI which is defined by the second strut 884 and the third strut 886 and a second length D2 which is defined by the first stmt 882 and the fourth stmt 888. In some examples the first length DI can be equal to the second length D2, which can help to ensure that the cell 880 collapses at the apex 883 when the cell 880 is transitioned to the collapsed state.

[0212] When the prosthetic heart valve is deployed and the turns of the docking device expand, the brim will advance distally (i.e. towards the coils of central region 708 of the docking device 700). In some examples, the apex 883 is at a proximal end of the cell 880, such that the leading-edge during valve deployment is the soft corner 885 and not the sharper apex 883.

[0213] In some examples, the lateral terminal lobe 808 can comprise a protrusion 809 which extends radially inward near the proximal-most cell 880 to shelter the apex 883 from interacting with the anatomy and / or the prosthetic heart valve. Furthermore, as depicted in FIG. 18 the apices could be designed to have blunt ends 883a which can have the advantage of providing a rounded end to inhibit damaging the cover material of the guard member.

[0214] In some examples, the scaffold 800 may have a kickout portion 824 adjacent to the medial terminal lobe 806. The kickout portion 824 may have the advantage of more easilyDocket No.: TMTTM3-24264WO01wrapping the spine 810 from the outflow side (bottom as depicted) to the inflow side of the stabilization turn, for example the stabilization turn 710. In some examples, the kickout portion 824 can be positioned where the guard member transitions from the outflow side of the stabilization turn 710 to the top inflow side of the stabilization turn 710. The kickout portion 824 can be shape set to be sloped such that it is it is lower on the first side of the kickout portion 824 so that it can be attached to the bottom of the stabilization turn 710, and higher on the second side where it rests on the top of the stabilization turn 710. The kickout portion described for scaffold 800 may be used with any of the other scaffolds described herein.

[0215] FIG. 19 depicts a scaffold 800a, according to another example. In some examples, the scaffold 800a can share features with the scaffolds described above, for example the scaffold 800. In some examples, the scaffold 800a is similar to the scaffold 800, except for the differences described below. However, the scaffold 800a described below need not include all the components described above. The scaffold 800a can comprise a radially inward portion with four cells 880a. The cells 880a can be formed from a first stmt 882a (also referred to as a “proximal stmt”), a second stmt 884a (also referred to as an “inner stmt”), a third stmt 886a (also referred to as a “distal stmt”), and a fourth stmt 888a (also referred to as an “outer stmt”). In some examples, as depicted, the fourth stmt 888a can comprise a portion of the main spine 810. In the depicted example, there are four cells 880a, which are elongate when compared to the cells 880 of scaffold 800.

[0216] FIGS. 20A-20B depict partial views of a scaffold 800b and a scaffold 800c. In some examples, the scaffolds 800b, 800c can share features with any of the scaffolds described above, for example the scaffold 800 or the scaffold 800a. In some examples, the scaffolds 800b, 800c are similar to the scaffold 800 and / or the scaffold 800a, except for the differences described below. However, the scaffolds 800b, 800c described below need not include all the components described above.

[0217] In some examples, the cells can be open cells which do not completely surround an internal opening with stmts on all sides and / or which have one or more openings or breaks in the stmts. As depicted in FIGS. 20A-20B, in some examples, the cells can comprise an opening in one or more of the stmts which results in the cell being at least partially open. These openings can have the advantage of improved collapsibility of the cells as they are moved from the radially expanded configuration to the radially compressed configuration. FIG. 20A depicts a cell 880b comprising a first stmt 882b, a second stmt 884b, a third stmtDocket No.: TMTTM3-24264WO01886b, and a fourth strut 888b. The cell 880b further comprises an opening 870a disposed between a first strut 882b and a second strut 884b. In the depicted example, there is a partial strut 872 that extends from the first strut 882 and extends circumferentially in the same direction as the second strut. This can have the advantage of adding stability and improving radial retention with the prosthetic heart valve. FIG. 20B depicts a cell 880c comprising a first strut 882c, a second strut 884c, a third strut 886c, and a fourth strut 888c. The cell 880b further comprises an opening 870b in a cell 880c, in this example there is a partial strut 874 which extends radially outward from the second stmt 884c. The partial views of the scaffold 800b and the scaffold 800c only depict one cell each, however, the scaffold 800b and the scaffold 800c can each comprise a plurality of cells with openings in them.

[0218] FIGS. 21-22 depict views of a scaffold 800d and a scaffold 800e. In some examples, the scaffolds 800d, 800e can share features with any of the scaffolds described above, for example the scaffold 800 or any of the scaffolds 800a, 800b, 800c. In some examples, the scaffolds 800d, 800e are similar to the scaffold 800 and / or the scaffolds 800a, 800b, 800c, except for the differences described below. However, the scaffolds 800d, 800e described below need not include all the components described above.

[0219] As depicted in FIGS. 21-22, in some examples, the radially inward portion of the scaffold can comprise strut elements which can comprise fewer than four struts. In some examples, as depicted in FIG. 21, the scaffold 800d comprises a radially inward portion which comprises one or more stmt elements comprising an inner stmt 884d and a distal stmt 886d. As in the other scaffolds described herein the distal stmt has one end coupled to the main spine 810 and a second end coupled to the inner stmt 884d. The inner stmt 884d has one end coupled to the distal stmt 886d and the other end free. In some examples, as depicted in FIG. 22, the scaffold 800e comprises stmt elements comprising an inner stmt 884e and a distal stmt 886e. In some examples, the inner stmt 884e can have blunt ends 883e which can have the advantage of providing a rounded end to inhibit damaging the cover material of the guard member.

[0220] FIG. 23 depicts views of a scaffold 800f. In some examples, the scaffolds 800f can share features with any of the scaffolds described above, for example the scaffold 800 or any of the scaffolds 800a, 800b, 800c, 800d, 800e. In some examples, the scaffold 800f is similar to the scaffold 800 and / or the scaffolds 800a, 800b, 800c, 800d, 800e, except for the differences described below. However, the scaffold 800f described below need not include all the components described above. FIG. 24 depicts the scaffold 800f with a radially inwardDocket No.: TMTTM3-24264WO01portion comprising a plurality of strut elements 890. As depicted, the strut elements 890 can be replaced with any one of cells 890a, 890b, 890c, 890d or a combination thereof. The strut elements can comprise a fist strut 892, a second strut 894, and a third strut 896.

[0221] FIGS. 24-28 depict scaffolds 900, 900a, 900b, 900c which comprise a radially inward portion which comprises a single cell which is formed by a second spine which is disposed radially inward from the main spine. In some examples, the scaffolds 900, 900a, 900b, 900c can share features with the scaffolds described above, for example the scaffold 800. Similar to the other scaffold discussed herein, the scaffolds 900, 900a, 900b, 900c can comprise a main spine 910, a plurality of arms 914, a medial terminal lobe 906, and a lateral terminal lobe 908. In some examples, the medial terminal lobe 906 can comprise a first apex 920 and a circumferentially extending partial arm 915 can be coupled to the first apex 920. In some examples, the scaffolds 900, 900a, 900b, 900c are similar to the scaffold 800, except for the differences described below. However, the scaffolds 900, 900a, 900b, 900c described below need not include all the components described above.

[0222] FIG. 24 depicts the scaffold 900 which can comprise an inner spine 911. The inner spine can extend from a protrusion 909 on the lateral terminal lobe to the medial terminal lobe 906 and can be curved to match the curve of the main spine 910. The smooth inner spine 911 can have the advantage of a large contact area with an expanded prosthetic heart valve which can increase the retention force.

[0223] FIG. 25 depicts the scaffold 900a which can comprise an inner spine 911a which defines a pattern, such as a zig-zag pattern and / or wave pattern, to help equalize arc length of the inner spine 91 la to the arc length of the main spine 10, while maintaining smaller diameter for improved retention and sealing. When the inner spine 91 la is straightened out, for example when loaded into the delivery catheter it can straighten out to match the length of the main spine 910. In some examples, the amount, size, and shape of the wave / zigzag pattern can be altered.

[0224] FIG. 26 depicts the scaffold 900b in which an inner spine 911b and the main spine 910 converge into the lateral terminal petal 908. This has the advantage of greater flexibility and allows the guard member to straighten out when loaded into the delivery catheter.

[0225] FIG. 27 depicts the scaffold 900c which comprises an inner spine 911c that is attached to the medial terminal petal and is free on the end that is adjacent to the lateral terminal petal. This has the advantage of enabling ease of straightening out the guard memberDocket No.: TMTTM3-24264WO01when it is loaded into the delivery catheter. In some examples, an eyelet 91 Ih can be added to the disconnected end to provide a rounded end to inhibit damaging the cover material of the guard member. In some examples, the inner spine 911c may have a thick wall to counteract the reduced retention strength of a disconnected end.

[0226] FIG. 28 depicts the scaffold 900d which comprises a first inner spine 91 Id (also referred to as a “first segment”) and a second inner spine 913d (also referred to as a “second segment”). This may have the advantage of helping to equalize the radial strength along the inner spines. In some examples, eyelets or blunt ends can be added to the disconnected ends of the first inner spine 91 Id and / or the second inner spine 913d, as shown, to inhibit damaging the cover material of the guard member.

[0227] FIGS. 29-30 depict aspects of guard members which can have a scaffold with a radially inward portion which comprises a plurality of cells. In some examples, the cells may be similar to the cells described above except they may include an apex where the first strut meets the second strut that forms a less acute angle than the cells described above. In some examples, increasing the angle of this apex can mean that the one or more cells are limited in the amount they extend radially inward from the spine. This cell configuration can, for example, prevent the cells from protruding through the cover material of the radially inward flap. In some examples, due to the apex with a larger angle, an inner strut of each of the cells may be straight instead of curved and may make partial rather than full contact with the prosthetic valve when it is expanded within the docking device. This partial contact can, for example, prevent (or reduce) the atrial turn from moving relative to the prosthetic valve and / or the prosthetic valve from moving relative to the native anatomy. Additionally (or alternatively), the cells may also provide structure to a radially inward portion of a flap which covers the scaffold and can help to prevent PVL from occurring between dock and valve.

[0228] FIG. 29 depicts a scaffold 1000 with a radially inward portion comprising a plurality of cells which comprise an apex with a relatively large angle where the first strut meets the second strut. In some examples, the scaffold 1000 can share features with the scaffolds described above, for example the scaffold 800. For example, the scaffold a can comprise a main spine 1010, a plurality of arms 1014, a medial terminal lobe 1006, and a lateral terminal lobe 1008. In some examples, the medial terminal lobe 1006 can comprise a first apex 1020 and a circumferentially extending partial arm 1015 can be coupled to the first apex 1020. In some examples, the scaffold 1000 is similar to the scaffold 800, except for the differencesDocket No.: TMTTM3-24264WO01described below. However, the scaffold 1000 described below need not include all the components described above.

[0229] In the depicted example, the scaffold 1000 comprises a radially inward portion with five cells 1080. In some examples, the radially inward portion of the scaffold 1000 can comprise fewer cells or more cells. For example, the radially inward portion of the scaffold can comprise between 2 and 7 cells. The cells 1080 can be formed from a first stmt 1082 (also referred to as a “proximal stmt”), a second stmt 1084 (also referred to as an “inner stmt”), a third stmt 1086 (also referred to as a “distal stmt”), and a fourth stmt 1088 (also referred to as an “outer stmt”). In some examples, as depicted, the fourth stmt 1088 can comprise a portion of the main spine 1010.

[0230] In the depicted example, the second stmt 1084 is not curved to accommodate the circular outer diameter of the prosthetic heart valve. The second stmt 1084 may be a straight line (or at least a substantially straight line) from the first stmt 1082 to the third stmt 1086. When the scaffold is in the expanded state, the first stmt 1082 forms an apex 1083 with the second stmt 1084. The apex 1083 can define a larger angle than the apex 883 (shown in FIG.17). In some examples, the apex 1083 can define an angle between 30 degrees and 60 degrees. In some examples, the apex 1083 can define an angle of 40 degrees. In some examples, the one or more cells 1080 extend between 1 mm to 3 mm radially inward from the spine 1010. In some examples, the one or more cells 1080 extend 2 mm radially inward from the spine 1010. Configuring the cells 1080 in this manner can, for example, help to inhibit damage to the guard member (e.g., reduce the likelihood of the apices 1083 of the one or more cells 1080 protruding through the flap material when the guard member is in a compressed state in a delivery orientation).

[0231] In some examples, the connection between the second strut 1084 and the third strut 1086 can have a comer 1085 which can be softer or more flexible than the second strut 1084 and or third stmt 1086. In some examples, the corner 1085 is thinner to reduce strains when straightened in the collapsed state.

[0232] When the guard member is moved to a delivery orientation, each cell 1080 can be collapsed towards the main spine 1010 to fit inside the delivery shaft (e.g. the delivery shaft 490). The cell 1080 can have a first length D3 which is defined by the second strut 1084 and the third strut 1086 and a second length D4 which is defined by the first strut 1082 and the fourth stmt 1088. In some examples the first length D3 can be equal to the second length D4,Docket No.: TMTTM3-24264WO01which can help to ensure that the cell 1080 collapses at the apex 1083 when the cell 1080 is transitioned to the collapsed state.

[0233] FIG. 30 depicts a docking device 1100 which can share features with the docking devices described above, for example the docking device 600. In some examples, the docking device 1100 is similar to the docking device 600, except for the differences described below. However, the docking device 1100 described below need not include all the components described above. The docking device can comprise a guard member 1104 comprising a scaffold, for example, similar to the scaffold 1000, which can be fitted with a flap 1140 which can be sized or adapted to fit over the scaffold. In some examples, flap 1140 covers a medial terminal lobe 1144 and a lateral terminal lobe 1146. In some examples, any of the flaps described herein, for example the flap 1140 can comprise a cover as described in Attorney Docket No. THVMC-24462US01, which is incorporated by reference herein in its entirety.

[0234] The docking device 1100 is configured to receive a prosthetic implant, for example the prosthetic heart valve 1190. The docking device 1100 has a stabilization turn 1110 with a first lumen diameter 1105a which can be larger than a second lumen diameter 1105b of the coils in the central region, so that the stabilization turn 1110 can extend radially outwardly so as to abut or push against the walls (or annulus) of the circulatory system, thereby improving the ability of the docking device 1100 to stay in its desired position prior to the implantation of the prosthetic valve. This feature may enhance docking device stability (e.g., in larger anatomies).

[0235] FIG. 30 depicts the docking device 1100 with the prosthetic heart valve 1190 installed, which can expand the diameter of the coils in the central region and therefore expand the second diameter 1105b. The second lumen diameter 1105b can be similar to the second lumen diameter 705b of the docking device 700 when the prosthetic heart valve 1190 is not installed. In some examples, before the heart valve 1190 is implanted the first lumen diameter 1105a is between 5 percent and 50 percent greater than the second lumen diameter 1105b. In some examples, before the heart valve 1190 is implanted the first lumen diameter 1105a is between 10 percent and 25 percent greater than the second lumen diameter 1105b. In some examples, before the heart valve 1190 is implanted the first lumen diameter 1105a can be between 20 mm and 30 mm and the second lumen diameter 1105b can be between 18 mm and 25 mm. In some examples, before the heart valve 1190 is implanted the second lumen diameter 1105b can be 22 mm and the first lumen diameter 1105a can be 26 mm. ThisDocket No.: TMTTM3-24264WO01difference between the first lumen 1105a diameter and the second lumen diameter 1105b can create an opening between the stabilization turn 1110 and the coils of the central region of the coil. The guard member 1104 can comprise a radially inward portion 1150 which can cover an opening between the stabilization turn 1110 and the coils in the central region.

[0236] The radially inward portion 1150 of the guard member 1104 can comprise a scaffold with a radially inward portion which can be fitted with the flap which is sized or adapted to fit over the radially inward portion. In some examples, the radially inward portion 1150 of scaffold comprises one or more cells 1180 that all share a side with a main spine of a scaffold (as depicted the main spine of the scaffold is positioned behind the stabilization turn 1110) and protrude radially inward. The one or more cells 1180 can be designed such that the most radially inward portion of each cell is positioned to provide radial retention once the prosthetic heart valve 1190 is in the deployed configuration. As described above, in some examples, the radially innermost portion (i.e. the inner strut 1184) of each cell 1180 is not curved to accommodate the circular outer diameter of the prosthetic heart valve 11 0. In some examples, the radially innermost portion of each cell may be a strut that is at least substantially a straight line. While this design does not offer full contact to prosthetic heart valve 1190 the amount of contact is adequate to help prevent the stabilization turn 1110 from moving excessively relative to the prosthetic valve 1190 and / or the native anatomy. In addition, the portion of the flap 1140 covering the radially inward cells 1180 remains the same as described above and helps to prevent PVL from occurring between docking device 1100 and the prosthetic heart valve 1190.

[0237] FIGS. 31-33 depict aspects of scaffolds for guard members which have a radially inward portion which comprises a scaffold with one or more cells which may be similar to the cells described above. In some examples, the cells may be limited in the amount they extend radially inward from the spine. In some examples, the cells may have similar advantages to the cells described above. In the depicted examples, the radially inward cells are each formed by a curved strut which can be attached to the spine of the scaffold at each end of the curved strut. In some examples, the curve of the strut is opposite to the curve of the spine. These curved struts may reduce or prevent the stmts from protruding through the cover material of the radially inward flap. In some examples, the stmt of each of the cells may make partial rather than full contact with the prosthetic valve when it is expanded within the docking device. This partial contact is enough to help to prevent the atrial turn from moving relative to the prosthetic valve when it is inserted and expanded. These cells can reduce theDocket No.: TMTTM3-24264WO01delivery profile while maintaining the retention forces needed between the guard member and the prosthetic implant. Guard members comprising one of these scaffolds can have one or more of the advantages and features described and shown elsewhere herein. For example, guard members comprising one of the scaffolds and a flap can reduce PVL.

[0238] FIG. 31 depicts a scaffold 1200 for a guard member according to another example. In some examples, the scaffold 1200 can share features with the scaffolds described above, for example the scaffold 1000. For example, the scaffold 1200 can comprise a main spine 1210, a plurality of arms 1214, a medial terminal lobe 1206, and a lateral terminal lobe 1208. In some examples, the scaffold 1200 is similar to the scaffold 1000, except for the differences described below. However, the scaffold 1200 described below need not include all the components described above.

[0239] The scaffold 1200 can comprise a radially inward portion with one or more cells 1280. Each of the one or more cells 1280 can be formed from a portion of the main spine 1210 and a curved strut 1282 which can be attached to the spine of the scaffold at each end of the curved strut 1282. As depicted, the curved strut 1282 is attached at a proximal point 1281 (also referred to as a “first position”) and a distal point 1283 (also referred to as a second position”), where “proximal” and “distal” can be defined by the orientation of the guard member during delivery. In other words, the curved strut 1282 can extend from a first position on the spine to a second position on the spine, wherein the first position is closer to the first end portion (closer to the lateral terminal lobe 1208) and the second position is closer to the second end portion (closer to the medial terminal lobe 1206) of the main spine 1210. In some examples, there may be between one and six cells 1280. In the depicted example, there are three cells 1280.

[0240] FIG. 32 depicts a detail view of a single cell 1280 including a portion of the main spine 1210 and the curved strut 1282 which is attached to the main spine 1210 at the proximal point 1281 and the distal point 1283. As depicted, the proximal point 1281 and the distal point 1283 can be positioned on the main spine 1210 at locations circumferentially offset from the base portions 1214b of the arms 1214. This spacing may have advantages for reducing strains when the scaffold is compressed to the deliver)' orientation, for example when being loaded into a delivery catheter. In some examples, the cell defines a main spine length LA and a curved strut length LB. In some examples, the length LA is approximately equal to the length LB. This can help to minimize sleeved strains and accommodate the curved (deployed orientation) and straightened (delivery orientation) configurations. In someDocket No.: TMTTM3-24264WO01examples, there is a 1-5% length difference between the length LA and the length LB. In some examples, the length LB is greater than the length LA. In some examples, the main spine 1210 defines a first arc with an arc radius rAand the curved strut 1282 defines a second arc with a stmt arc radius m which can be approximately equal to balance the strains in the curved and loaded configurations. In some examples, however, the arc radius m can either be larger or smaller than the arc radius TA, for example, if the center of the curve is shifted further away or closer to the brim’s center, respectively. Adjusting the stmt arc radius TB relative to the arc radius rAof the main spine 1210 can adjust the retention force applied between the cells 1280 and the prosthetic heart valve when it is deployed within a docking device comprising the scaffold 1200.

[0241] In some examples, as shown in FIG. 31, the inner radius of the scaffold can define different segments which can have different stiffnesses. In the depicted example, the scaffold 1200 comprises a first segment Si, a second segment S2, a third segment S3, a fourth segment S4, a fifth segment S5, a sixth segment Se, and a seventh segment S7. In some examples, the one or more cells 1280 increase the stiffness of the main spine 1210 in some of the segments of the inner radius. In the depicted example, cells 1280 are disposed along the second segment S2, the fourth segment S4. and the sixth segment Se. The curved stmts 1282 can have a thickness WB. In some examples, the thickness WB can be in a range between 0.15 mm and 0.35 mm. In some examples, the thickness WB can be 0.25 mm. In some examples, the thickness WB can be selected to change the radial strength of the curved stmt 1282. The main spine can have nominal thickness WN, for example, where it is part of a cell 1280. In some examples the nominal thickness WN can be in a range between 0.15 mm and 0.35 mm. In some examples, the thickness WN can be 0.25 mm. Adding the curved stmt 1282 increases the stiffness of the guard member along segments of the inner radius which comprise one of the one or more cells 1280. In the depicted example, the second segment S2, the fourth segment S4, and the sixth segment Se have an increased stiffness because of overlap of the curved stmts 1282 and the main spine 1210 in these segments.

[0242] In some examples, the thickness Ws of the main spine 1210 in between the one or more cells 1280 may be selected to help control the stiffness of the guard member. In some examples, the main spine 1210 has a thickness Ws in between the one or more cells 1280 which may be thicker than to help control the stiffness of the guard member. In some examples the nominal thickness Ws can be in a range between 0.2 mm and 0.4 mm. In some examples, the thickness Ws can be 0.3 mm. In some examples, the thickness Wsmay beDocket No.: TMTTM3-24264WO01increased in the third segment S3 and the fifth segment S5. In some examples, the thickness Wsmay be increased in the first segment Si, the third segment S3, the fifth segment S5, and the seventh segment S7. In some examples, the thickness Wsmay be increased in any combination of these segments.

[0243] FIG. 33 depicts aspects of a scaffold 1300 according to another example. In some examples, the scaffold 1300 can share features with the scaffolds described above, for example the scaffold 1200. For example, the scaffold 1300 can comprise a main spine 1310, a plurality of arms 1314, a medial terminal lobe 1306, and a lateral terminal lobe 1308. In some examples, the scaffold 1300 is similar to the scaffold 1200, except for the differences described below. However, the scaffold 1300 described below need not include all the components described above. The scaffold 1300 can comprise a radially inward portion with cells 1380. Each of the one or more cells 1380 can be formed from a portion of the main spine 1310 and a curved strut 1382 which can be attached to the spine of the scaffold at each end of the curved strut 1382. In some examples, there may be between one and eight (or three to six) cells 1380. In the depicted example, there are four cells 1380.

[0244] FIGS. 34-39 depict aspects of guard members which can be positioned partially on the outflow side (bottom as depicted) and partially on the inflow side (top as depicted) of the stabilization turn of a coil. These guard members can have features which allow a portion of the coil to pass through the guard member where the guard member transitions from the outflow side to the inflow side of the stabilization turn. In some examples, the guard member includes a flap covering at least a portion of an area between an outer radius and an inner radius of the guard member and a hole is positioned between the outer radius and the inner radius and configured to allow the coil of the docking device to pass through the flap. In some examples, the scaffold of the guard member can include a bend portion which is disposed on the scaffold and extends inward towards a central point and is configured to wrap around the stabilization turn of the docking device. The guard members depicted in FIGS. 34-39 may reduce the extent in which the guard member / coil connection interacts with native tissue, for example, the native medial commissure. In some instances, a guard member may move slightly relative to the coil during prosthetic valve deployment.

[0245] FIGS. 34-35B depict aspects of a docking device 1400 which can share features with the docking devices described above, for example the docking device 1100. In some examples, the docking device 1400 is similar to the docking device 1100, except for the differences described below. However, the docking device 1400 described below need notDocket No.: TMTTM3-24264WO01include all the components described above. The docking device 1400 can define a lumen 1420 and a longitudinal axis 1401. The docking device can comprise a central region 1408, a stabilization coil 1410, a guard member 1404 comprising a scaffold with a flap 1440 which can be sized or adapted to fit over the scaffold. In some examples, flap 1440 covers a medial terminal lobe 1444 and a lateral terminal lobe 1446.

[0246] In some examples, the guard member 1404 is coupled at least partially to an outflow side (the underside as depicted in FIG. 34) of the stabilization coil 1410. In some examples, the guard member 1404 is coupled to the outflow side of the stabilization coil 1410 extending circumferentially between 180 and 330 degrees. In some examples, the guard member 1404 is coupled to the outflow side of the stabilization coil 1410 extending circumferentially between 225 and 315 degrees. In some examples, the guard member 1404 is coupled to the outflow side of the stabilization coil extending circumferentially approximately 270 degrees.

[0247] The guard member 1404 may define at least a partial anulus around a central point defined by the longitudinal axis 1401. The annulus comprises an inner radius 1422 and an outer radius 1424 and the flap 1440 may comprise a cover disposed around the scaffold covering at least a portion of an area between the inner radius 1422 and the outer radius 1424. As depicted, the guard member 1404 can further comprise a hole 1430 positioned between the inner radius 1422 and the outer radius 1424 and configured allow a portion of the stabilization turn 1410 to pass through the flap 1440. The hole 1430 allows the guard member 1404 to be coupled at least partially to an outflow side of the coil of the first coil region. In some examples, as depicted, the hole 1430 is located adjacent to the medial terminal lobe 1444.

[0248] Passing the stabilization turn 1410 through the hole 1430 may have the advantage of limiting the connection between the guard member 1404 and stabilization turn from interacting with the native medial commissure. In some examples, the hole 1430 in the guard member 1404 allows movement between the guard member and the coil during prosthetic valve deployment. In some examples, the guard member 1404 is attached to the stabilization turn 1410 by one or more sutures. In some examples, there is an attachment point 1431 adjacent to the hole 1430. In some examples, extra slack can be built into flap 1440 in the region between hole 1430 and the fixed attachment point 1431, allowing the hole 1430 to slide towards the fixed attachment point 1431 when it interacts with the native tissue, such as the native chordae and leaflets. This configuration can, for example, provide a softer interaction with the native tissue. As tissue interacts with the flap 1440 material adjacent toDocket No.: TMTTM3-24264WO01the hole 1430, the extra slack in the cloth gets pushed back, allowing the guard member to “crumple.” This can allow the guard member 1404 to get pushed back by the native tissue, rather than the guard member 1404 pushing against the native tissue if the coils of the docking device move relative to the native tissue during the procedure.

[0249] FIG. 35A depicts an underside of the guard member 1404 including an underside of the medial petal 1444. From this perspective, it can be seen that after the stabilization turn 1410 passes through the hole 1430 in the flap 1440 such that a portion of the stabilization turn 1410 is positioned below the medial petal 1444. The cloth of the guard member 1404 surrounding the hole 1430 is not coupled to the stabilization turn 1410 such that the flap 1440 of the guard member 1404 and the stabilization turn 1410 can move relative to one another.

[0250] FIG. 35B depicts an underside of the guard member 1404 including an underside of the medial petal 1444. FIG. 35B further depicts a protective patch 1434 which can be coupled to the guard member 1404 adjacent to the hole 1430. The hole 1430 can extend through the flap 1440 and the patch 1434. Neither the cloth of the guard member 1404 nor the patch 1434 surrounding the hole 1430 is fixedly coupled to the coil, thereby allowing relatively movement therebetween. The patch 1434 can be added to provide an additional protective layer between the native tissue and the bottom of guard member 1404 where it may interact with native tissue, such as the medial commissure. In some examples, the patch 1434 may comprise a soft material, such as ePTFE and can be used to cover the PET cloth, sutures, and struts of the guard member 1404.

[0251] FIGS. 36A-37 depict a scaffold 1500 for a guard member which can be similar to the scaffolds described above. For example, the scaffold 1500 can comprise a main spine 1510, a plurality of arms 1514, a medial terminal lobe 1506, a lateral terminal lobe 1508, and a circumferentially extending partial arm 1515. The scaffold 1500 may define a central point 1501. The scaffold 1500 is depicted without a radially inward portion, however, a person of skill in the art having the benefit of this disclosure would understand that the scaffold 1500 could include a radially inward portion, for example comprising one or more cells. In some examples, the scaffold 1500 may have abend portion 1532 disposed adjacent to the medial terminal lobe 1506 and configured to help the scaffold wrap around a stabilization turn so that a guard member comprising the scaffold 1500 can be more easily coupled at least partially to an outflow side of a stabilization turn and can rest at least partially on the inflow side of the stabilization turn.Docket No.: TMTTM3-24264WO01

[0252] FIG. 36B depicts the scaffold 1500 installed on a coil 1502. For illustration purposes, the scaffold 1500 is depicted without a flap, however, the scaffold 1500 can be used with any of the flaps described herein to form a guard member. In some examples, the bend portion 1532 can be positioned where the scaffold 1500 transitions from the outflow side to the inflow side of the stabilization turn 1511. The bend portion 1532 may have the advantage of more easily wrapping the spine 1510 from the outflow side (bottom as depicted) to the inflow side (top as depicted) of the stabilization turn 1511.

[0253] FIG. 37 depicts the scaffold 1500 in a flattened configuration. As described above, the scaffolds described herein, for example scaffold 1500 can comprise a shape memory material, such as Nitinol. The flattened scaffold 1500 as depicted in FIG. 37 can be shape set to be biased toward the deployed orientation (i.e. the orientation depicted in FIGS. 36A-36B).

[0254] FIG. 38 depicts a scaffold 1600 with a bend in a flattened configuration according to another example. The scaffold 1600 can share features with the scaffolds described above, for example the scaffold 1500. For example, the scaffold 1600 can comprise a main spine 1610, a plurality of arms 1614, a medial terminal lobe 1606, a lateral terminal lobe 1608, and a circumferentially extending partial arm 1615. The scaffold 1600 may define a central point 1601. In some examples, the scaffold 1600 is similar to the scaffold 1500, except for the differences described below. However, the scaffold 1600 described below need not include all the components described above. As depicted, the scaffold 1600 comprises a bend portion 1632 located on the medial terminal lobe 1606. A guard member comprising the scaffold 1600 and a flap can further comprise a hole positioned between the outer radius and the inner radius of the guard member and configured allow a portion of a stabilization turn of a coil to pass through the flap. The hole allows the guard member to be coupled at least partially to an outflow side of the coil of the first coil region. In some examples, the hole is located though the flap which covers the medial terminal lobe. In other words, the hole can be disposed adjacent to the bend portion 1632.

[0255] FIG. 39 depicts a scaffold 1700 with a bend according to another example. The scaffold 1600 can share features with the scaffolds described above, for example the scaffold 1600. In some examples, the scaffold 1700 is similar to the scaffold 1600, except for the differences described below. For example, the scaffold 1700 can comprise a main spine 1710, a plurality of arms 1714, a medial terminal lobe 1706, and a circumferentially extending partial arm 1715. The scaffold 1700 may have a bend portion 1732 disposed adjacent to the medial terminal lobe 1706. However, the scaffold 1700 described below need not include allDocket No.: TMTTM3-24264WO01the components described above. The scaffold 1700 illustrates how the scaffolds depicted in FIGS. 36A-38 can comprise a radially inward portion which comprises one or more cells 1780.

[0256] The guard members and scaffolds depicted in FIGS. 34-39 can allow guard members to be positioned partially on the outflow side and partially on the inflow side of the stabilization turn of a coil. These guard members can have features which allow a portion of the coil to pass through the guard member where the guard member transitions from the outflow side to the inflow side of the stabilization turn. The guard members depicted in FIGS.34-39 may have the advantage of limiting the guard member coil connection from interacting with native tissue, for example, the native medial commissure. In some examples, the guard members allow a small amount of movement between the guard member and the coil during prosthetic valve deployment which can allow a portion of the guard member to get pushed back by the tissue, rather than the guard member pushing the tissue forward when the docking device is clocked during the docking device implantation procedure and during prosthetic valve deployment.

[0257] FIGS. 40-41 depict aspects of a docking device with an atrial stabilization turn which is offset from the circle formed by the functional turns. In some examples, the stabilization turn forms a circle which is offset from the circle formed by the functional turns. The offset region of the stabilization turn can be configured to sit on the P2 and P3 region of the posterior leaflet of the mitral valve and can help to reduce the risk of large mitral regurgitation. The stabilization turn may also be a similar size to the outer diameter of the prosthetic implant which can help ensure that the stabilization turn interacts with the prosthetic implant and provides radial retention once the prosthetic implant is in the deployed configuration. This can help prevent the stabilization turn from moving excessively relative to the prosthetic implant and / or the native anatomy after the prosthetic implant is deployed within the docking device.

[0258] FIG. 40 depicts a docking device 1800 comprising a coil 1802. In some examples, the docking device 1800 is similar to the other docking device described herein, for example the docking device 100, 200 except for the differences described below. For example, the docking device 1800 can comprise an inflow side and an outflow side and can include a stabilization turn 1810 (also referred to as a “stabilization coil” or a “first coil region”), a central region 1808 (also referred to as “functional turns” or a “second coil region”), and a leading turn 1806 (or “leading coil”), each of which are disposed around a central lumen, etc.Docket No.: TMTTM3-24264WO01some components may not be repeated here for sake of brevity. However, the docking device 1800 need not include all of the components described above. In some examples, the docking device can further comprise a guard member which can comprise a flap and any of the scaffolds described herein, for example, the scaffold 1600 depicted in FIG. 38.

[0259] In the depicted example, an attachment portion 1812 is disposed at a proximal end portion of the stabilization turn 1810. This attachment portion terminates in a proximal end 1813. The attachment portion 1812 can be configured to releasably couple the coil 1802 to a delivery apparatus (for example, docking device delivery apparatus 50).

[0260] FIG. 40 depicts a top-down view of the docking device 1800 with an offset stabilization turn 1810. The stabilization turn 1810 defines a first circle having a first center point 1801 and radius R1 , and the central region 1808 defines a second circle having a second center point 1803 and radius R2. The first center point 1801 and the second center point 1803 are spatially offset. In some examples, the first circle and the second circle are internally tangent circles (such that the spatial offset of the first center point 1801 and the second center point 1803 equals |R 1— R2|) and the circles may overlap near a proximal end portion, i.e. near the attachment portion 1812, of the stabilization turn 1810. In this offset configuration each helical turn of the second coil region 1808 lies substantially within a nominal radius, a second radius R2, about the first center point 1801. In other words, a portion 1810a of the stabilization turn 1810 can extend radially outward from the second radius R2 of the second coil region 1808 and the proximal end portion 1812 of the stabilization turn 1810 may be disposed substantially at the second radius R2 relative to the second center point 1803.

[0261] As used herein, the “first circle” refers to a circle defined by first coil region (e.g., the stabilization turn 1810), with a first center point 1801 and first radius Rl, and the “second circle” refers to a circle defined by the second coil region (e.g., the central region 1808), with a second center point 1803 and second radius R2. Internally tangent can mean the two circles touch at exactly one point with the first circle enclosing the second circle. The term “nominal radius” of the second coil region denotes the radius measured from the second center point 1803 of the second coil region 1808 such that each helical turn of the second coil region lies substantially within that radius prior to prosthetic implant deployment.

[0262] The offset configuration allows the atrial turn to stabilize the device while minimizing interference with native anatomy and maximizing prosthetic valve anchoring. FIG. 41 depicts a cutaway view of a portion of the human heart H, including the mitral valveDocket No.: TMTTM3-24264WO01MV and portions of the aortic valve AV, with the docking device 1800 implanted at the mitral valve MV. The mitral valve MV includes an anterior leaflet defined by regions Al, A2, and A3 and a posterior leaflet defined by regions Pl, P2, and P3, the mitral valve includes a medial commissure MC, where the anterior leaflet and the posterior leaflet meet. The docking device 1800 can be implanted such that the second coil region 1808 of the coil 1802 are positioned below the mitral valve MV and the stabilization turn 1810 of the coil 1802 is positioned above the mitral valve MV. The coil 1802 can cross from the inflow side (i.e., the top) of the mitral valve MV to the outflow side (i.e., the bottom) of the mitral valve MV at the medial commissure MC. In other words, the coil 1802 can cross the annulus at a mitral valve medial commissure MC. The offset geometry can position the portion 1810a of the stabilization turn 1810 to sit on the P2 and P3 region of the native mitral valve, which may improve valve coaptation and sealing.

[0263] In some examples, before the prosthetic implant is deployed within the coil 1802 the first radius R1 is larger than the second radius R2. In some examples, before the prosthetic implant is deployed the first and second circles are internally tangent, and a proximal end portion of the first coil region is disposed substantially at the second radius R2 of the second coil region 1808 while another portion of the stabilization turn 1810 extends radially outward beyond the nominal radius. After prosthetic implant deployment, the second coil region 1808 can expand with the prosthetic implant outer diameter. In some examples, the stabilization turn 1810 can maintain a larger effective diameter to continue providing atrial stabilization. The diameter of the stabilization turn 1810 may match the outer diameter of a prosthetic implant which may help to ensure direct interaction between the stabilization turn 1810 and the prosthetic implant frame after the prosthetic implant is deployed within the docking device. This interaction can help prevent post-implantation motion of the stabilization turn 1810 and can enhance anchoring stability.

[0264] In some cases, implant visibility during a procedure can be limited. FIGS. 42-45G depict various docking devices and / or guard members which include one or more markers which can aid users with visibility during implantation. To improve visibility, one or more radiopaque markers or features on the docking device can be included to enhance implant positioning and deployment during the implantation procedure. A 3D marker specifically can aid in visibility during deployment when the implant is positioned at different angles.Described below are examples of guard members with markers which may improve visibility for users during an implantation procedure.Docket No.: TMTTM3-24264WO01

[0265] In some examples, the marker positioned on the guard member (e.g., on a medial terminal lobe) is used intra-procedurally to determine a clocking position and commissural alignment of the docking device relative to the native annulus, and to confirm that the medial terminal lobe remains on the inflow / atrial side prior to prosthetic heart valve deployment.

[0266] FIG. 42 depicts an example of a docking device 1900 having a radiopaque marker 1950 that can be visually observed during an implantation procedure. In some examples, the docking device 1900 is similar to the docking devices described above, for example the docking device 700, except for the differences described below. However, the docking device 1900 described below need not include all the components described above. The docking device 1900 defines a lumen 1920 and a longitudinal axis 1901 has a stabilization turn 1910 with a first lumen diameter 1905a which can be larger than a second lumen diameter 1905b of the coils in the central region 1908. The guard member 1904 of the docking device 1900 comprises a scaffold and a flap 1940 which can be sized or adapted to fit over the scaffold. In some examples, the scaffold can comprise a spine, a plurality of arms extending radially outward from the spine, and one or more terminal lobes. In some examples, the guard member comprises a medial terminal lobe 1944 and a lateral terminal lobe 1946. Although in FIG. 42 the medial terminal lobe 1944 is depicted as being on top of (i.e., superior to) the lateral terminal lobe 1946 to better illustrate the radiopaque marker 1950, the lateral terminal lobe 1946 will be on top of (i.e., superior to) the medial terminal lobe 1944 when deployed within a subject’s body (see, e.g., FIG. 34).

[0267] In some examples, the radiopaque marker 1950 can provide visual indication about the location of the guard member 1904 relative to its surrounding anatomy, and / or the amount of radial expansion thereof under fluoroscopy. Also, the radiopaque marker 1950 can be used to identify location of the docking device 1900 (for example, when a prosthetic valve is subsequently deployed in the docking device) under fluoroscopy. For example, one or more radiopaque markers can be placed on the guard member. In one particularly example, a radiopaque marker can be disposed on the edge of the medial terminal lobe 1944. Positioning the marker 1950 on the medial terminal lobe 1944 may help the user to ensure that the medial terminal lobe 1944 is positioned on the correct side of the native anulus, i.e., the medial terminal lobe 1944 is positioned on the inflow side of the native anulus. In some examples, placing the marker 1950 on the medial terminal lobe 1944 may help the user to determine the position (e.g., rotational position, which can also be referred to as “clocking”) of the docking device 1900 relative to the native anatomy, for example, because the relationship between theDocket No.: TMTTM3-24264WO01medial terminal lobe 1944 and the stabilization turn 1910 is known, knowing the position of the medial terminal lobe 1944 can help the user to position the stabilization turn 1910 to cross the medial commissure at the desired location.

[0268] FIGS. 43A-43C depict an example of steps to attach the marker 1950 to the guard member 1904. As depicted, the marker 1950 may comprise a three dimensional bead. In some examples, the marker 1950 may comprise a sphere with a through-hole 1954. A suture 1952 may be passed through the through-hole 1954 one or more times to couple the marker 1950 to the material of the flap. In the depicted example, the suture 1952 forms one or more stitches along an edge portion of the medial terminal lobe 1944. The suture passes through the material of the flap 1940 at a first position 1956, through the through-hole 1954 of the bead, back through the material of the flap 1940 at a second position 1958, then back through the flap material at the first position 1956. The suture 1952 can then be passed through the through-hole 1954 of the bead a second time and back through the flap material at the second position 1958. The line of stitching is then continued along the edge of the medial lobe 1944.

[0269] FIG. 44 depicts a docking device 1900' comprising a marker 1950' disposed on a medial terminal lobe 1944 and within the material of the flap 1940. A stitch line 1952' may be added to form a smaller pocket in which the marker can be contained. Putting the marker inside the material of the flap 1940 may have advantages, for example, it may reduce the interaction with the native tissues.

[0270] In some examples, any of the scaffolds disclosed herein can include one or more marker retention features. Coupling radiopaque markers to retention features on the scaffold can have the advantage of reducing assembly complexity. FIGS. 45A-45F depict various examples of portions of a scaffold 2000 which is modified with one or more marker retention features. The scaffold 2000 can share features with the scaffolds described above. For example, the scaffold 2000 can comprise a main spine 2010, a plurality of arms 2014, and a medial terminal lobe 2006. However, the scaffold 2000 described below need not include all the components described above. Any of the scaffolds disclosed herein can be modified to include any of the marker retention features disclosed for the scaffold 2000. The modifications to the scaffold 2000 depicted are on the medial terminal lobe 2006, however, the marker retention features can be placed on other parts of the scaffold.

[0271] The retention features can be formed unitary with the scaffold (e.g., laser-cut from the same Nitinol stock) and the 3D radiopaque marker (e.g., a spherical bead) can be coinedDocket No.: TMTTM3-24264WO01or friction-fit into the retention feature. In some examples, the retention feature is shape-set out of the scaffold plane (e.g., approximately 90°) to enhance multi-angle fluoroscopic visibility.

[0272] The modifications to the scaffold 2000 may enhance visibility for users during an implantation procedure by incorporating coined radio-opaque markers directly into the scaffold 2000. The modification of the scaffold 2000 to accommodate these markers can simplify the overall assembly process and eliminate the need for through-holes or additional suturing steps. This can reduce the manufacturing complexity and also improve the consistency and reliability of marker placement. The marker retention features may be configured to retain at least one radiopaque marker which may be coined directly into a desired shape. For example, the markers can be coined into a rounded spherical shape, forming a 3D marker without the need for separate attachment. The coining process can comprise applying mechanical force to the marker to shape the marker to conform to the geometry of the retention feature. The markers described below can enhance visibility from multiple angles during the implantation procedure.

[0273] Examples of retention features are depicted in FIGS. 45A-45F include variations in marker geometry and mounting techniques, such as tab mounts, 90-degree twist shape sets, and clamshell configurations. These options allow for customization based on procedural needs and device design constraints, further expanding the applicability of the technology across different implant platforms. Any of the retention figures described below can have markers disposed within them, in some instances the retention features are depicted without the markers for simplicity.

[0274] FIG. 45A depicts a scaffold 2000 with two retention features. A first retention feature 2052a is disposed at the tip of the medial terminal lobe 2006 and a second retention feature 2054a is located at the point where the medial terminal lobe 2006 is attached to the spine 2010. In the depicted example, both the first retention feature 2052a and the second retention feature 2054a are round. A marker 2050' can be disposed within the first retention feature 2052a, and can be coined to be retained within the retention feature. In some examples, coining can comprise inserting the marker 2050' into the first retention feature 2052a and then applying a mechanical percussive force to deform the marker 2050' so that it has an overhanging lip on either side of the first retention feature 2052a. A marker 2050 can be disposed within the second retention feature 2054a and can be coined to be retained within the retention feature. In some examples, coining can involve placing the marker 2050 into theDocket No.: TMTTM3-24264WO01second retention feature 2054a and then applying a applying a mechanical percussive force to deform the marker 2050 in the radial outward direction such that it is friction fitted within the second retention feature 2054a.

[0275] FIG. 45B depicts a second retention feature 2054b according to another example. The second retention feature 2054b is elongate in one direction and forms a rounded rectangle. The retention features described herein can be formed in other shapes such as ovals, rectangles, etc. A non-circular marker can enhance visibility from multiple angles during the implantation procedure and allow a user to determine the orientation of the marker.

[0276] FIGS. 45C-45E depicts a retention feature, according to other examples, which can include a marker 2050". The marker 2050" can be a spherical marker which can have the advantage of increasing visibility during deployment when the implant is positioned at different angles. FIG. 45C depicts a tine retention feature 2056, which comprises a tine which is bent around the marker 2050”. FIG. 45D depicts a clam shell retention feature 2052e, which comprises a first layer 2053 and a second layer 2055, wherein the first layer 2053 can be similar to the first retention feature 2052a described above and the second layer 2055 can comprise a ring of material configured to be coupled with the first layer 2053 to retain the marker 2050". FIG. 45E depicts a retention feature 2052f, according to another example, the marker 2050" can be friction fit within the retention feature 2052f.

[0277] FIG. 45F depicts a shape set retention feature 2052g which is positioned, for example twisted, out of a plane defined by the scaffold 2000, e.g. a plane defined by the medial terminal lobe 2006. In some examples, the shape set retention feature 2052g can be twisted out of the plane defined by the medial terminal lobe 2006 in a range of 0 degrees to 180 degrees. In some examples, the shape set retention feature 2052g can be twisted out of the plane defined by the medial terminal lobe 2006 in a range of 45 degrees to 135 degrees. In the depicted example, the shape set retention feature 2052g is twisted 90 degrees out of the plane defined by the medial terminal lobe 2006.

[0278] FIGS. 46A-47 depict improvements to scaffold manufacturing methods for docking devices. These methods introduce a modular approach to scaffold manufacturing which can improve material efficiency and manufacturability. These methods are depicted for a scaffold 2102 but can be applied to any of the scaffolds disclosed herein. As depicted in FIG. 46 A, previously the scaffold 2102 had been laser cut entirely from flat Nitinol sheets 2103. ThisDocket No.: TMTTM3-24264WO01process can lead to significant material waste due to the scaffold’s geometry and the inability to nest parts efficiently.

[0279] The method depicted in FIG. 46B and FIG. 47 separates the scaffold into components: the spine 2110, one or more inner cells 2180, a medial terminal lobe 2106, a lateral terminal lobe 2108, and one or more arms 21 14. The spine 2110 can be laser cut from a sheet 2105, such as a Nitinol sheet. This can have the advantage of forming a spine 2110 which has a flat side, for example, the spine 2110 can have a rectangular cross section. The flat side can help to ensure secure attachment to the round portions of a coil (e.g. any of the coils described herein) which can help prevent rotational movement. Cutting the spines 2110 from the sheet 2105 separate from the other components of the scaffold can allow for a higher yield of spines per sheet and simplifies the cutting process.

[0280] In some examples, the one or more inner cells 2180, the medial terminal lobe 2106, the lateral terminal lobe 2108, and the one or more arms 2114 can be manufactured separately using wire, such as Nitinol wires, ribbons, or sheets. The one or more inner cells 2180, the medial terminal lobe 2106, the lateral terminal lobe 2108, and the one or more arms 2114 can then be attached to the spine, for example, using welding techniques. In some examples, the spine 2110 and the one or more inner cells 1280 can optionally be cut from the same sheet of material as depicted in FIG. 46B.

[0281] Arm head portions can comprise a rounded end or an eyelet to reduce trauma to the native tissue, prevent the head from protruding through the cover material, and / or accommodate stitching. In some examples, forming the one or more arms 2114 out of the second piece of material comprises forming head portions at a radially outward portion of each arm of the one or more amis 2114.

[0282] The modular construction described above not only reduces raw material waste but can also enable the use of Nitinol forms with superior quality control. In some examples, the method described above can offer better dimensional consistency which can enhance reliability and performance. By separating the spine and arm fabrication into separate steps, the process becomes more adaptable and scalable, supporting future design iterations and manufacturing improvements. The method described above may have the advantages of being more cost-effective, improving material utilization, and enhancing product quality, while maintaining the functional integrity required for successful implantation.Docket No.: TMTTM3-24264WO01

[0283] FIGS. 48A-49D depict suture patterns for securing a flap material to a scaffold. The guard member 2204 can be similar to any of the guard members for docking devices described above, except for the differences described below. The guard member 2204 comprises a scaffold 2202 and a flap 2240 which can be sized or adapted to fit over the scaffold 2202. In some examples, the scaffold can comprise a spine 2210, a plurality of arms 2214 extending radially outward from the spine, one or more inner cells 2280, and one or more terminal lobes, for example a medial terminal lobe 2206. The guard member 2204 can have an inflow side 2260 and an outflow side 2270, where the outflow side 2070 is the side that is in contact with the native tissue when a docking device comprising the guard member 2204 is deployed.

[0284] The flap 2240 can be can be attached to the scaffold 2202 using a suture 2290. In some examples, the suture 2290 may be a continuous length of suture. In some examples, the suture 2290 may comprise a plurality of non-continuous lengths. The stitch patterns described below can be designed to provide a robust mechanical connection between the material of the flap 2240 and the scaffold 2202 and minimize interactions between a docking device and native tissue during implantation. The stitch patterns described below can, for example, reduce adverse interactions with native mitral valve tissue.

[0285] FIG. 48A-48C depict a stitching pattern for coupling the flap 2240 to the scaffold 2202 according to a first example. As depicted, the material of the flap 2240 can be attached to the scaffold 2202 using a stitching pattern that routes a suture 2290 around the arms 2214 to form one or more first stitches 2292a and one or more second stitches 2292b. In this configuration, both the first stitches 2292a on the outflow side 2270 and the second stitches on the inflow side 2260 cross the arm 2214, this is depicted schematically in FIG. 48D which is a depiction of one arm 2214 on the outflow side 2270. This configuration provides a robust mechanical connection between the material of the flap 2240 and the arms 2214 of the scaffold 2202 ensuring that the arms 2214 remain securely fixed during delivery and deployment. This stitching pattern can have the advantages of predictable assembly and consistent alignment of the guard member relative to the coil structure, which can be advantageous for maintaining device geometry throughout the implantation process.

[0286] FIG. 49A-49D depict a stitching pattern for coupling the flap 2240 to the scaffold 2202 according to a second example. As depicted, the material of the flap 2240 can be attached to the scaffold 2202 using a stitching pattern that routes a suture 2290 around the arms 2214 to form one or more first stitches 2294a and one or more second stitches 2294b. InDocket No.: TMTTM3-24264WO01this configuration, both the first stitches 2294a on the outflow side 2270 extend parallel to the arms 2214 and the second stitches 2294b on the inflow side 2260 cross the arm 2214, this is depicted schematically in FIG. 49D which is a depiction of one arm 2214 on the outflow side 2270. This approach can create a smooth, low-profile interface while maintaining strong attachment integrity. The parallel stitching method can distribute load evenly along the guard member and minimizes material bulk, which can improve compatibility with delivery sleeves and facilitate streamlined deployment. In some examples, a finer suture, such as a 7-0 UHMWPE, can further enhance flexibility and reduce overall profile without compromising strength.

[0287] The disclosed docking devices can, in some instances, be used as standalone implants without a prosthetic valve deployed within the docking device. For example, a docking device can encircle the native leaflets and / or chordae of a native valve and draw the native tissue radially inward. This engagement with the native tissue can improve the functionality of the native valve (e.g., by reducing regurgitation). The disclosed docking devices can thus also be referred to as “repair devices” and / or “prosthetic implants.”

[0288] In some examples, any of the docking devices described herein may be deployed to improve the functionality of the native valve during an implantation procedure. If the physician is satisfied with the function of the native valve after implanting the docking device, the physician can complete the implantation procedure without implanting a prosthetic heart valve. If the physician is unsatisfied with the function of the native valve after implanting the docking device, however, the physician can continue the implantation procedure by deploying a prosthetic heart valve within the docking device before completing the implantation procedure. In some instances, after the initial implantation procedure, a physician can adjust the docking device and / or implant a prosthetic heart valve within the docking device as part of another procedure (e.g., if the patient’s condition changes after the initial implantation procedure).

[0289] Accordingly, the docking devices disclosed herein can be used as standalone valve repair devices or in conjunction with prosthetic heart valves. The disclosed docking devices therefore provide a physician with improved flexibility and / or options for treating patients, which can improve patient outcomes.Delivery TechniquesDocket No.: TMTTM3-24264WO01

[0290] For implanting a prosthetic valve within the native aortic valve via a transfemoral delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral artery and are advanced into and through the descending aorta, around the aortic arch, and through the ascending aorta. The prosthetic valve is positioned within the native aortic valve and radially expanded (for example, by inflating a balloon, actuating one or more actuators of the delivery apparatus, or deploying the prosthetic valve from a sheath to allow the prosthetic valve to self-expand). Alternatively, a prosthetic valve can be implanted within the native aortic valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native aortic valve. Alternatively, in a transaortic procedure, a prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the aorta through a surgical incision in the ascending aorta, such as through a partial J-stemotomy or right parasternal mini-thoracotomy, and then advanced through the ascending aorta toward the native aortic valve.

[0291] For implanting a prosthetic valve within the native mitral valve via a transseptal delivery approach, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, into the right atrium, across the atrial septum (through a puncture made in the atrial septum), into the left atrium, and toward the native mitral valve. Alternatively, a prosthetic valve can be implanted within the native mitral valve in a transapical procedure, whereby the prosthetic valve (on the distal end portion of the delivery apparatus) is introduced into the left ventricle through a surgical opening in the chest and the apex of the heart and the prosthetic valve is positioned within the native mitral valve.

[0292] For implanting a prosthetic valve within the native tricuspid valve, the prosthetic valve is mounted in a radially compressed state along the distal end portion of a delivery apparatus. The prosthetic valve and the distal end portion of the delivery apparatus are inserted into a femoral vein and are advanced into and through the inferior vena cava, and into the right atrium, and the prosthetic valve is positioned within the native tricuspid valve. A similar approach can be used for implanting the prosthetic valve within the native pulmonary valve or the pulmonary artery, except that the prosthetic valve is advancedDocket No.: TMTTM3-24264WO01through the native tricuspid valve into the right ventricle and toward the pulmonary valve / pulmonary artery.

[0293] Another delivery approach is a transatrial approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through an atrial wall (of the right or left atrium) for accessing any of the native heart valves. Atrial delivery can also be made intravascularly, such as from a pulmonary vein. Still another delivery approach is a transventricular approach whereby a prosthetic valve (on the distal end portion of the delivery apparatus) is inserted through an incision in the chest and an incision made through the wall of the right ventricle (typically at or near the base of the heart) for implanting the prosthetic valve within the native tricuspid valve, the native pulmonary valve, or the pulmonary artery.

[0294] In all delivery approaches, the delivery apparatus can be advanced over a guidewire previously inserted into a patient’s vasculature. Moreover, the disclosed delivery approaches are not intended to be limited. Any of the prosthetic valves disclosed herein can be implanted using any of various delivery procedures and delivery devices known in the art.

[0295] Any of the systems, devices, apparatuses, etc. herein can be sterilized (for example, with heat / thermal, pressure, steam, radiation, and / or chemicals, etc.) to ensure they are safe for use with patients, and any of the methods herein can include sterilization of the associated system, device, apparatus, etc. as one of the steps of the method. Examples of heat / thermal sterilization include steam sterilization and autoclaving. Examples of radiation for use in sterilization include, without limitation, gamma radiation, ultra-violet radiation, and electron beam. Examples of chemicals for use in sterilization include, without limitation, ethylene oxide, hydrogen peroxide, peracetic acid, formaldehyde, and glutaraldehyde. Sterilization with hydrogen peroxide may be accomplished using hydrogen peroxide plasma, for example.

[0296] The treatment techniques, methods, steps, etc. described or suggested herein or in references incorporated herein can be performed on a living animal or on a non-living simulation, such as on a cadaver, cadaver heart, anthropomorphic ghost, simulator (for example, with the body parts, tissue, etc. being simulated), etc.Additional Examples of the Disclosed Technology

[0297] In view of the above-described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken inDocket No.: TMTTM3-24264WO01combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.

[0298] Example 1. A guard member, for a docking device for securing a prosthetic implant at a native valve, the guard member comprising: a scaffold with a spine defining an arc in a deployed orientation and comprising a first end portion and a second end portion; and a terminal lobe extending from the first end portion of the spine, the terminal lobe comprising an apex pointed towards the second end portion of the spine, wherein the guard member is movable between a radially compressed state in a delivery orientation and a radially expanded state in the deployed orientation.

[0299] Example 2. The guard member of any example herein, particularly example 1, further comprising a plurality of arms extending from the spine.

[0300] Example 3. The guard member of any example herein, particularly any one of examples 1-2, further comprising an arm extending from the apex of the terminal lobe.

[0301] Example 4. The guard member of any one of any example herein, particularly any one of examples 1-3, wherein the terminal lobe is a first terminal lobe, wherein the guard member further comprises a second terminal lobe, and wherein the second terminal lobe comprises a second apex pointed towards the first end portion of the spine.

[0302] Example 5. The guard member of any example herein, particularly any one of examples 1-4, further comprising a flap fitted over the scaffold.

[0303] Example 6. A docking device comprising: the guard member of any example herein, particularly any one of examples 1-5; and a coil comprising at least one helical turn, wherein the guard member is attached to at least a portion of the at least one helical turn.

[0304] Example 7. A guard member, for a docking device for securing a prosthetic implant at a native valve, the guard member comprising: a spine comprising a first end portion and a second end portion and defining an arc extending from the first end portion to the second end portion in a deployed orientation; and a terminal lobe extending from the first end portion of the spine; and one or more arms coupled to the spine between the first end portion and the second end portion and each arm of the one or more arms comprising a head portion which is disposed radially outward from the spine and in a first circumferential direction, wherein the one or more arms comprises a first arm which is disposed adjacent to the terminal lobe, and wherein the first arm further comprises a second distal end portion disposed radially outward from the spine and in a second circumferential direction, wherein the guard member isDocket No.: TMTTM3-24264WO01movable between a radially compressed state in a delivery orientation and a radially expanded state in the deployed orientation.

[0305] Example 8. The guard member of any example herein, particularly example 7, further comprising a cover extending over at least one of the spines, the terminal lobe, and the one or more arms.

[0306] Example 9. A docking device comprising: the guard member of any example herein, particularly any one of examples 7-8; and a coil, wherein the guard member is sutured to the coil.

[0307] Example 10. A guard member, for a docking device for securing a prosthetic implant at a native valve, the guard member comprising: a curved spine which defines a plane; and

[0308] a plurality of arms extending from the spine and defining a first angle relative to the plane, wherein the first angle is within a range of 5-80 degrees, wherein the guard member is movable between a radially compressed state in a delivery orientation and a radially expanded state in a deployed orientation.

[0309] Example 11. The guard member of any example herein, particularly example 10, wherein the first angle is within a range of 15-60 degrees.

[0310] Example 12. The guard member of any example herein, particularly example 10, wherein the first angle is in a range of 20-40 degrees.

[0311] Example 13. The guard member of any example herein, particularly any one of examples 10-12, further comprising a first terminal lobe extending from a first end portion of the curved spine.

[0312] Example 14. The guard member of any example herein, particularly example 13, further comprising a second terminal lobe extending from a second end portion of the curved spine.

[0313] Example 15. The guard member of any example herein, particularly any one of examples 13-14, wherein the first terminal lobe and / or the second terminal lobe extends from the spine such that the first terminal lobe and / or the second terminal lobe define a second angle relative to the plane.

[0314] Example 16. The guard member of any example herein, particularly any one of examples 14-15, wherein the second terminal lobe comprises a distal end portion defining a third angle relative to the plane, wherein third angle is greater than the second angle.Docket No.: TMTTM3-24264WO01

[0315] Example 17. A docking device for securing a prosthetic valve, the docking device comprising: a coil comprising: a longitudinal axis extending through a lumen of the coil from an inflow side to an outflow side; a first coil region defining a first lumen diameter and configured to be disposed on the inflow side of a native annulus and to stabilize the coil relative to the native annulus; and a second coil region extending from a distal end of the first coil region and comprising one or more helical turns each defining a second lumen diameter and configured to be disposed on an outflow side of a native annulus and to receive a prosthetic valve, wherein the first lumen diameter is in a range of 10 percent to 30 percent greater than the second lumen diameter; and a guard member comprising: a curved spine comprising a radially inward portion; and one or more inner struts extending radially inward from the curved spine.

[0316] Example 18. The docking device of any example herein, particularly example 17, wherein the guard member further comprises one or more terminal lobes.

[0317] Example 19. The docking device of any of any example herein, particularly any one of examples 17-18, wherein the guard member further comprises one or more outer arms extending radially outward from the spine.

[0318] Example 20. A guard member, for a docking device for securing a prosthetic implant at a native valve, the guard member comprising: a spine defining an arc, the arc extending between a first end portion and a second end portion; one or more cells extending radially inward from the spine; one or more anus extending radially outward from the spine; a first terminal lobe and a second terminal lobe, wherein the first terminal lobe is disposed at the first end portion and the second terminal lobe is disposed at the second end portion of the spine.

[0319] Example 21. The guard member of any example herein, particularly example 20, wherein the one or more cells are closed cells relative to the spine.

[0320] Example 22. The guard member of any example herein, particularly example 20, wherein the one or more cells are open cells relative to the spine.

[0321] Example 23. The guard member of any example herein, particularly example 20, wherein the one or more cells extending radially inward from the spine each comprise a first strut, a second strut, and a third strut, wherein a first end of each of the first strut and third strut is coupled to the spine and a second end of each of the first strut and third strut is coupled to the second stmt.Docket No.: TMTTM3-24264WO01

[0322] Example 24. The guard member of any example herein, particularly any one of examples 20-23, wherein the one or more cells extending radially inward comprises five cells.

[0323] Example 25. The guard member of any example herein, particularly any one of examples 20-23, wherein the one or more cells extending radially inward comprises four cells.

[0324] Example 26. The guard member of any example herein, particularly any one of examples 20-25, wherein the guard member is configured to be coupled to a coil of a docking device and the one or more cells are configured to extend radially inward from the coil and the one or more arms, the first terminal lobe, and the second terminal lobe are configured to extend radially outward from the coil.

[0325] Example 27. The guard member of any example herein, particularly any one of examples 20-26, further comprising a flap.

[0326] Example 28. A docking device comprising: the guard member of any of any example herein, particularly any one of examples 20-27 ; and a coil attached to the guard member, wherein the coil comprises a lumen configured to receive a prosthetic heart valve.

[0327] Example 29. A guard member, for a docking device for securing a prosthetic implant at a native valve, the guard member comprising: a spine defining an arc, the arc extending between a first end portion and a second end portion; one or more strut elements extending radially inward from the spine; one or more arms extending radially outward from the spine; two terminal lobes, wherein the terminal lobes are disposed at the first end portion and the second end portion of the spine.

[0328] Example 30. The guard member of any example herein, particularly example 29, wherein each of the one or more strut elements comprise a plurality of struts.

[0329] Example 31. The guard member of any example herein, particularly example 29, wherein each of the one or more strut elements defines a cell and each cell comprises four struts.

[0330] Example 32. A guard member, for a docking device for securing a prosthetic implant at a native valve, the guard member comprising: a first spine comprising a first end portion and a second end portion and defining an arc between the first end portion and the second endDocket No.: TMTTM3-24264WO01portion; and a second spine disposed radially inward from the first spine and comprising a first end portion and a second end portion.

[0331] Example 33. The guard member of any example herein, particularly example 32, further comprising one or more arms extending radially outward from the first spine.

[0332] Example 34. The guard member of any example herein, particularly any one of examples 32-33 further comprising a first terminal lobe disposed at the first end portion of the first spine; and a second terminal lobe disposed at the second end portion of the first spine.

[0333] Example 35. The guard member of any example herein, particularly any one of examples 32-34, wherein the first end portion and the second end portion of the second spine are coupled to the first spine.

[0334] Example 36. The guard member of any example herein, particularly any one of examples 32-35, wherein the second spine has a zig-zag pattern.

[0335] Example 37. The guard member of any example herein, particularly any one of examples 32-34 wherein the first end portion of the second spine is coupled to the first spine, and wherein the second end portion of the second spine is not coupled to the first spine.

[0336] Example 38. The guard member of any example herein, particularly any one of examples 32-34, wherein the second spine comprises a first segment and a second segment.

[0337] Example 39. The guard member of any example herein, particularly example 38, wherein a first segment of the second spine is coupled to the first end portion of the first spine, wherein the second segment of the second spine is coupled to the second end portion of the first spine, and wherein the first and second segments of the second spine extend circumferentially towards each other.

[0338] Example 40. The guard member of any example herein, particularly any one of examples 32-39, further comprising a flap.

[0339] Example 41. A docking device comprising: the guard member of any example herein, particularly any one of examples 32-40 and further comprising a coil, wherein the guard member is configured to be attached to the coil by being coupled to at least a portion of a helical turn thereof.

[0340] Example 42. A method comprising: delivering the docking device of any example herein, particularly any one of examples 6, 9, 17-19, 28, or 41 to a native valve via a deliveryDocket No.: TMTTM3-24264WO01apparatus, wherein the coil of the docking device is in an axially-elongate configuration; deploying the docking device from the delivery apparatus at an annulus of the native valve, wherein the docking device moves from the axially-elongate configuration to a deployed orientation; and deploying a prosthetic valve from the delivery apparatus into the docking device.

[0341] Example 43. A guard member, for a docking device for securing a prosthetic implant at a native valve, the guard member comprising: a spine defining an arc, the arc extending between a first end portion and a second end portion; and one or more cells extending radially inward from the spine, wherein the one or more cells each comprise a first strut, a second strut, and a third strut, wherein a first end of each of the first strut and third strut is coupled to the spine and a second end of each of the first strut and third strut is coupled to the second strut, wherein the guard member is movable between a compressed state and an expanded state, and wherein when the guard member is in the expanded state, the first strut forms an angle with the second strut between 30 degrees and 60 degrees.

[0342] Example 44. The guard member of any example herein, particularly example 43, further comprising one or more arms coupled to the spine and extending radially outward and the first end of the first strut is coupled to the spine at a position on the spine proximal to an arm of the one or more arms, and the first end of the third strut is coupled to the spine at a position on the spine distal to the arm of the one or more arms.

[0343] Example 45. The guard member of any example herein, particularly any one of examples 43-44, wherein when the guard member is in the expanded state, the one or more cells extending radially inward extend between 1 mm to 3 mm radially inward from the spine.

[0344] Example 46. The guard member of any example herein, particularly any one of examples 43-45, further comprising a cover wherein the cover is disposed around the spine and the one or more cells.

[0345] Example 47. A docking device for securing a prosthetic implant at a native valve, comprising the guard member of any example herein, particularly any one of examples 43-46 and further comprising a coil, wherein the guard member is configured to be attached to the coil by being coupled to at least a portion of a helical turn thereof.

[0346] Example 48. A guard member, for a docking device for securing a prosthetic implant at a native valve, the guard member comprising: a spine defining an arc, the arc extending between a first end portion and a second end portion; and one or more cells extending radiallyDocket No.: TMTTM3-24264WO01inward from the spine wherein the one or more cells each comprise a curved strut which each extend from a first position on the spine to a second position on the spine, wherein the first position is closer to the first end portion and the second position is closer to the second end portion, wherein the guard member is movable between a compressed state and an expanded state.

[0347] Example 49. The guard member of any example herein, particularly example 48, wherein a curve of each of the curved struts is opposite to a curve of the arc defined by the spine.

[0348] Example 50. The guard member of any example herein, particularly any one of examples 48-49, further comprising one or more arms coupled to the spine and extending radially outward and wherein the first position and the second position are radially offset from a base portion of the one or more arms.

[0349] Example 51. The guard member of any example herein, particularly any one of examples 48-50, wherein each of the curved struts defines a first length and a portion of the spine between the first position and the second position defines a second length and wherein the first length is equal to the second length.

[0350] Example 52. The guard member of any example herein, particularly any one of examples 48-50, wherein the curved struts each define a first length and a portion of the spine between the first position and the second position defines a second length and wherein the first length is between 1 percent to 5 percent greater than the second length.

[0351] Example 53. A guard member, for a docking device for securing a prosthetic implant at a native valve, the guard member comprising: a scaffold wherein the scaffold defines at least a partial an anulus around a central point the anulus comprising an outer radius and an inner radius; and a cover disposed around the scaffold covering at least a portion of an area between the inner radius and the outer radius and comprising a hole positioned between the inner radius and the outer radius and configured allow a coil of the docking device to pass through the cover, wherein the guard member is movable between a compressed state and an expanded state and wherein the guard member is configured to be coupled at least partially to an outflow side of a first coil region of the coil.

[0352] Example 54. The guard member of any example herein, particularly example 53, wherein the guard member comprises a medial terminal lobe and wherein the hole is located adjacent to the medial terminal lobe.Docket No.: TMTTM3-24264WO01

[0353] Example 55. The guard member of any example herein, particularly example 53. wherein the guard member comprises a medial terminal lobe and wherein the hole is located on the medial terminal lobe.

[0354] Example 56. The guard member of any example herein, particularly any one of examples 53-55, wherein the scaffold comprises a bend portion which bends inward towards the central point and which is configured to wrap around a coil of a first coil region of the docking device.

[0355] Example 57. The guard member of any example herein, particularly example 56, wherein the hole is positioned adj cent to the bend portion.

[0356] Example 58. A docking device comprising the guard member of any example herein, particularly any one of examples 53-57, and further comprising a coil, wherein the coil comprises a first coil region configured to be disposed on an inflow side of a native annulus and to stabilize the coil relative to the native annulus.

[0357] Example 59. A guard member, for a docking device for securing a prosthetic implant at a native valve, the guard member comprising: a scaffold wherein the scaffold defines at least a partial an anulus around a central point the anulus comprising an inner radius and an outer radius; and a bend portion disposed on the scaffold and extending inward towards the central point wherein the bend portion is configured to wrap around a coil of a first coil region of the docking device, wherein the guard member is movable between a compressed state and an expanded state and wherein the guard member is configured to be coupled at least partially to an outflow side of the coil of the first coil region.

[0358] Example 60. The guard member of any example herein, particularly example 59, wherein the guard member comprises a medial terminal lobe and wherein the bend portion is located adjacent to the medial terminal lobe.

[0359] Example 61. The guard member of any example herein, particularly example 59, wherein the guard member comprises a medial terminal lobe and wherein the bend portion is located on the medial terminal lobe.

[0360] Example 62. A docking device for securing a prosthetic valve, the docking device comprising: a coil comprising: a longitudinal axis extending through a lumen of the coil from an inflow side to an outflow side; a first coil region configured to be disposed on the inflow side of a native annulus and to stabilize the coil relative to the native annulus; a second coil region extending from a distal end of the first coil region and comprising one or more helicalDocket No.: TMTTM3-24264WO01turns and configured to be disposed on an outflow side of a native annulus and to receive a prosthetic valve; and a guard member comprising: a scaffold which defines at least a partial an anulus around a central point the anulus comprising an inner radius and an outer radius; and a cover disposed around the scaffold and comprising a hole positioned between the inner radius and the outer radius and configured allow the coil of the first coil region to pass through the cover.

[0361] Example 63. The docking device of any example herein, particularly example 62, wherein the scaffold comprises a bend portion which bends inward towards the longitudinal axis and which is configured to wrap around a coil of a first coil region.

[0362] Example 64. The guard member of any example herein, particularly example 63, wherein the hole is positioned adjacent to the bend portion.

[0363] Example 65. The guard member of any example herein, particularly any one of examples 62-64, wherein the guard member comprises a medial terminal lobe, and wherein the hole is located adjacent to the medial terminal lobe.

[0364] Example 66. The guard member of any example herein, particularly any one of examples 62-64, wherein the guard member comprises a medial terminal lobe, and wherein the hole is located on the medial terminal lobe.

[0365] Example 67. A docking device for securing a prosthetic valve, the docking device comprising: a first coil region configured to be disposed on an inflow side of a native annulus and to stabilize the docking device relative to the native annulus, wherein the first coil region defines a first circle; and a second coil region extending from a distal end of the first coil region and comprising one or more helical turns configured to be disposed on an outflow side of a native annulus and to receive a prosthetic valve wherein the second coil region defines a second circle, wherein prior to implantation of a prosthetic heart valve the first circle defines a first center point and a first radius and the second circle defines a second center point and a second radius, wherein the first center point is spatially offset from the second center point.

[0366] Example 68. The docking device of any example herein, particularly example 67, wherein the first radius is larger than the second radius.

[0367] Example 69. The docking device of any example herein, particularly example 67, wherein the first circle and the second circle are internally tangent circles.Docket No.: TMTTM3-24264WO01

[0368] Example 70. The docking device of any example herein, particularly example 69, wherein the first circle and the second circle overlap at a proximal end portion of the first coil region.

[0369] Example 71. The docking device of any example herein, particularly any one of examples 67-70, further comprising a guard member comprising a curved spine and one or more anus which extend radially outward.

[0370] Example 72. The docking device of any example herein, particularly any one of examples 67-71, wherein the first coil region is configured to overlap a portion of the native annulus.

[0371] Example 73. The docking device of any example herein, particularly example 72, wherein the native annulus is a mitral valve and when the docking device is installed, the first coil region is configured to engage a posterior leaflet.

[0372] Example 74. The docking device of any example herein, particularly example 73, wherein the first coil region is configured to engage a P2 / P3 region of the posterior leaflet of the mitral valve.

[0373] Example 75. A docking device for securing a prosthetic valve, the docking device comprising: a first coil region configured to be disposed on an inflow side of a native annulus and to stabilize the docking device relative to the native annulus, wherein the first coil region defines a first longitudinal axis extending through a lumen of the first coil region from an inflow side to an outflow side; and a second coil region extending from a distal end of the first coil region and comprising one or more helical turns configured to be disposed on an outflow side of a native annulus and to receive a prosthetic valve wherein the second coil region defines a second longitudinal axis parallel to the first longitudinal axis, wherein the first longitudinal axis is offset from the second longitudinal axis such that when docking device is installed at the native annulus, the first coil region is configured to overlap a portion of the native annulus.

[0374] Example 76. The docking device of any example herein, particularly example 75, wherein the native annulus is a mitral valve and when the docking device is installed, the first coil region is configured to engage a posterior leaflet.

[0375] Example 77. The docking device of any example herein, particularly example 76, wherein the first coil region is configured to engage a P2 / P3 region of the posterior leaflet of the mitral valve.Docket No.: TMTTM3-24264WO01

[0376] Example 78. A docking device for securing a prosthetic valve, the docking device comprising: a first coil region configured to be disposed on an inflow side of a native annulus and configured to stabilize the docking device relative to the native annulus; and a second coil region extending from a distal end of the first coil region and comprising one or more helical turns configured to be disposed on an outflow side of a native annulus and to receive a prosthetic valve wherein the second coil region defines a longitudinal axis extending through a lumen of the second coil region from an inflow side to an outflow side, wherein each helical turn of the second coil region lies substantially within a nominal radius about the longitudinal axis, wherein a portion of the first coil region extends radially outward from the nominal radius of the second coil region, and wherein a proximal end portion of the first coil region is disposed at the nominal radius relative to the longitudinal axis.

[0377] Example 79. The docking device of any example herein, particularly example 78, further comprising a guard member comprising a curved spine and one or more arms which extend radially outward.

[0378] Example 80. A guard member for a docking device for securing a prosthetic implant at a native valve, the guard member comprising: a scaffold comprising a spine; a cover disposed around the scaffold; and a marker coupled to the scaffold, wherein the guard member is movable between a compressed state and an expanded state.

[0379] Example 81. The guard member of any example herein, particularly example 80. wherein the scaffold comprises one or more arms extending radially outward from the spine.

[0380] Example 82. The guard member of any example herein, particularly any one of examples 79-81, wherein the scaffold comprises one or more terminal lobes coupled to the spine.

[0381] Example 83. The guard member of any example herein, particularly example 80, wherein the marker is a 3D marker.

[0382] Example 84. The guard member of any one of any example herein, particularly examples 80-83, wherein the marker is a spherical marker.

[0383] Example 85. The guard member of any example herein, particularly any one of examples 80-84, wherein the marker comprises a through-hole.Docket No.: TMTTM3-24264WO01

[0384] Example 86. The guard member of any example herein, particularly any one of examples 80-85, wherein the scaffold comprises a medial terminal lobe and the marker is coupled to the medial terminal lobe.

[0385] Example 87. The guard member of any example herein, particularly any one of examples 80-86, wherein the scaffold comprises a retention feature and the marker is coupled to the retention feature.

[0386] Example 88. The guard member of any example herein, particularly example 87, wherein the retention feature is formed out of a unitary piece with the scaffold.

[0387] Example 89. The guard member of any example herein, particularly example 88, wherein the retention feature is a circle.

[0388] Example 90. The guard member of any example herein, particularly example 88, wherein the retention feature is a rounded rectangle.

[0389] Example 91. The guard member of any example herein, particularly any one of examples 88-90, wherein the retention feature is positioned out of a plane defined by the scaffold.

[0390] Example 92. The guard member of any example herein, particularly any one of examples 88-91, wherein the marker is coined within the retention feature.

[0391] Example 93. The guard member of any example herein, particularly any one of examples 80-86, further comprising a suture, wherein the suture stitches the marker to the cover.

[0392] Example 94. The guard member of any example herein, particularly any one of examples 86-93, wherein the cover defines a pocket around the medial terminal lobe of the scaffold and the marker is positioned inside the pocket.

[0393] Example 95. An assembly comprising the guard member of any example herein, particularly any one of examples 80-94, and further comprising a coil configured to receive a prosthetic heart valve.

[0394] Example 96. The assembly of any example herein, particularly example 95, further comprising a prosthetic heart valve implanted within a lumen of the coil.

[0395] Example 97. A method comprising: delivering the assembly of any one of examples 95-96 to a native valve; and deploying the assembly at an annulus of the native valve,Docket No.: TMTTM3-24264WO01wherein the assembly remains in an axially-elongate configuration when delivering the assembly and moves to a deployed orientation after the docking device is deployed.

[0396] Example 98. The method of any example herein, particularly example 97, wherein the coil comprises a first coil region and a second coil region, further comprising positioning the assembly such that a portion where the first coil region and the second coil region meet is positioned where the coil crosses the annulus.

[0397] Example 99. The method of any example herein, particularly any one of examples 97-98, wherein the coil crosses the annulus at a mitral valve medial commissure.

[0398] Example 100. The method of any example herein, particularly any one of examples 97-99, further comprising deploying a prosthetic heart valve within the assembly.

[0399] Example 101. A method comprising: delivering a docking device comprising a coil and a guard member to a native annulus; and positioning a marker on an atrial side of the native annulus wherein the marker is coupled to the guard member.

[0400] Example 102. The method of any example herein, particularly example 101, wherein the guard member comprises a medial terminal lobe and the marker is positioned on the medial terminal lobe.

[0401] Example 103. The method of any example herein, particularly any one of examples 101-102, further comprising determining a clocking position of the docking device based on a position of the marker.

[0402] Example 104. The method of any example herein, particularly any one of examples 101-103, further comprising deploying a prosthetic heart valve within the docking device.

[0403] Example 105. A method for assembling a guard member for a docking device, the method comprising; forming a spine out of a first piece of material; forming a plurality of arms out of a second piece of material; and attaching the plurality of arms to the spine, wherein the spine is a curved spine, and wherein the arms are attached to the spine such that the amis extend radially outward from the spine.

[0404] Example 106. The method of any example herein, particularly example 105, wherein the first piece of material comprises a cross section that is rectangular.

[0405] Example 107. The method of any example herein, particularly example 105, wherein forming the spine comprises cutting the spine out of a first piece of material, and whereinDocket No.: TMTTM3-24264WO01forming the plurality of arms comprises cutting the plurality of arms out of a second piece of material.

[0406] Example 108. The method of any example herein, particularly example 107, wherein the first piece of material is a sheet of material and the second piece of material is a wire.

[0407] Example 109. The method of any example herein, particularly any one of examples 105-108, wherein attaching the plurality of arms to the spine comprises welding a first end of each arm of the plurality of arms to the spine.

[0408] Example 110. The method of any example herein, particularly any one of examples 105-108, wherein forming the plurality of arms out of the second piece of material comprises forming head portions at a radially outward portion of each arm of the plurality of arms.

[0409] Example 111. A guard member for a docking device for securing a prosthetic implant at a native valve, the guard member comprising: a scaffold comprising a spine and an arm extending radially outward from the spine; and a flap fitted over the scaffold: and a plurality of stitches, wherein the flap is attached to the arm by the plurality of stitches, wherein the plurality of stitches extend radially outward along the arm.

[0410] Example 112. The guard member of any example herein, particularly example 111, wherein the plurality of stitches are formed by a continuous length of suture.

[0411] Example 113. The guard member of any example herein, particularly example 112, wherein the suture comprises an outer diameter in a range between 0.01 mm and 0.75 mm.

[0412] Example 114. The guard member of any example herein, particularly example 112, wherein the suture comprises an outer diameter of 0.05 mm.

[0413] Example 115. The guard member of any example herein, particularly any one of examples 111-114, wherein the arm is one of a plurality of amis and wherein the plurality of stitches attaches the flap to each arm of the plurality of arms.

[0414] Example 116. The guard member of any example herein, particularly any one of examples 111-115, wherein the guard member comprises a first side configured to be positioned on an annuls of a native valve and wherein the plurality of stitches on the first side extend parallel to the arm.

[0415] Example 117. A method for assembling a guard member for a docking device, the method comprising: fitting a flap over a scaffold, wherein the scaffold comprises a spine andDocket No.: TMTTM3-24264WO01an arm extending radially outward from the spine; and attaching the flap to the scaffold by forming a plurality of stitches spaced along the arm.

[0416] Example 118. The method of any example herein, particularly example 117, wherein the guard member comprises a first side configured to be positioned on an annuls of a native valve and wherein forming a plurality of stitches spaced along the arm comprises disposing the stitches on the first side so that they are parallel to the ami.

[0417] The features described herein with regard to any example can be combined with other features described in any one or more of the other examples, unless otherwise stated. For example, any one delivery apparatus can be combined with any one or more features of another delivery apparatus. As another example, any one or more features of one scaffold can be combined with any one or more features of another scaffold.

[0418] In view of the many possible ways in which the principles of the disclosure may be applied, it should be recognized that the illustrated configurations depict examples of the disclosed technology and should not be taken as limiting the scope of the disclosure nor the claims. Rather, the scope of the claimed subject matter is defined by the following claims and their equivalents.

Claims

Docket No.: TMTTM3-24264WO01Claims:

1. A guard member, for a docking device for securing a prosthetic implant at a native valve, the guard member comprising:a scaffold with a spine defining an arc in a deployed orientation and comprising a first end portion and a second end portion; anda terminal lobe extending from the first end portion of the spine, the terminal lobe comprising an apex pointed towards the second end portion of the spine,wherein the guard member is movable between a radially compressed state in a delivery orientation and a radially expanded state in the deployed orientation.

2. The guard member of claim 1, further comprising a plurality of arms extending from the spine.

3. The guard member of any one of claims 1-2, further comprising an arm extending from the apex of the terminal lobe.

4. The guard member of any one of claims 1-3, wherein the terminal lobe is a first terminal lobe, wherein the guard member further comprises a second terminal lobe, and wherein the second terminal lobe comprises a second apex pointed towards the first end portion of the spine.

5. A guard member, for a docking device for securing a prosthetic implant at a native valve, the guard member comprising:a spine comprising a first end portion and a second end portion and defining an arc extending from the first end portion to the second end portion in a deployed orientation; and a terminal lobe extending from the first end portion of the spine; andone or more arms coupled to the spine between the first end portion and the second end portion and each arm of the one or more arms comprising a head portion which is disposed radially outward from the spine and in a first circumferential direction, wherein the one or more arms comprises a first arm which is disposed adjacent to the terminal lobe, and wherein the first arm further comprises a second distal end portion disposed radially outward from the spine and in a second circumferential direction,wherein the guard member is movable between a radially compressed state in a delivery orientation and a radially expanded state in the deployed orientation.Docket No.: TMTTM3-24264WO016. A guard member, for a docking device for securing a prosthetic implant at a native valve, the guard member comprising:a curved spine which defines a plane; anda plurality of arms extending from the spine and defining a first angle relative to the plane, wherein the first angle is within a range of 5-80 degrees,wherein the guard member is movable between a radially compressed state in a delivery orientation and a radially expanded state in a deployed orientation.

7. A docking device for securing a prosthetic valve, the docking device comprising:a coil comprising:a longitudinal axis extending through a lumen of the coil from an inflow side to an outflow side;a first coil region defining a first lumen diameter and configured to be disposed on the inflow side of a native annulus and to stabilize the coil relative to the native annulus; anda second coil region extending from a distal end of the first coil region and comprising one or more helical turns each defining a second lumen diameter and configured to be disposed on an outflow side of a native annulus and to receive a prosthetic valve, wherein the first lumen diameter is in a range of 10 percent to 30 percent greater than the second lumen diameter; anda guard member comprising:a curved spine comprising a radially inward portion; andone or more inner struts extending radially inward from the curved spine.

8. The docking device of claim 7, wherein the guard member further comprises one or more terminal lobes.

9. A guard member, for a docking device for securing a prosthetic implant at a native valve, the guard member comprising:a spine defining an arc, the arc extending between a first end portion and a second end portion;Docket No.: TMTTM3-24264WO01one or more cells extending radially inward from the spine;one or more arms extending radially outward from the spine;a first terminal lobe and a second terminal lobe, wherein the first terminal lobe is disposed at the first end portion and the second terminal lobe is disposed at the second end portion of the spine.

10. A guard member, for a docking device for securing a prosthetic implant at a native valve, the guard member comprising:a spine defining an arc, the arc extending between a first end portion and a second end portion;one or more strut elements extending radially inward from the spine;one or more arms extending radially outward from the spine;two terminal lobes, wherein the terminal lobes are disposed at the first end portion and the second end portion of the spine.

11. A guard member, for a docking device for securing a prosthetic implant at a native valve, the guard member comprising:a first spine comprising a first end portion and a second end portion and defining an arc between the first end portion and the second end portion; anda second spine disposed radially inward from the first spine and comprising a first end portion and a second end portion.

12. A guard member, for a docking device for securing a prosthetic implant at a native valve, the guard member comprising:a spine defining an arc, the arc extending between a first end portion and a second end portion; andone or more cells extending radially inward from the spine,wherein the one or more cells each comprise a first strut, a second strut, and a third strut, wherein a first end of each of the first strut and third strut is coupled to the spine and a second end of each of the first strut and third stmt is coupled to the second stmt, wherein the guard member is movable between a compressed state and an expanded state, and wherein when the guard member is in the expanded state, the first stmt forms an angle with the second stmt between 30 degrees and 60 degrees.Docket No.: TMTTM3-24264WO0113. A guard member, for a docking device for securing a prosthetic implant at a native valve, the guard member comprising:a spine defining an arc, the arc extending between a first end portion and a second end portion; andone or more cells extending radially inward from the spine wherein the one or more cells each comprise a curved strut which each extend from a first position on the spine to a second position on the spine,wherein the first position is closer to the first end portion and the second position is closer to the second end portion, wherein the guard member is movable between a compressed state and an expanded state.

14. The guard member of claim 13, wherein a curve of each of the curved struts is opposite to a curve of the arc defined by the spine.

15. The guard member of any one of claims 13-14, further comprising one or more arms coupled to the spine and extending radially outward and wherein the first position and the second position are radially offset from a base portion of the one or more arms.

16. The guard member of any one of claims 13-15, wherein each of the curved struts defines a first length and a portion of the spine between the first position and the second position defines a second length and wherein the first length is equal to the second length.

17. The guard member of any one of claims 13-15, wherein the curved struts each define a first length and a portion of the spine between the first position and the second position defines a second length and wherein the first length is between 1 percent to 5 percent greater than the second length.

18. A guard member, for a docking device for securing a prosthetic implant at a native valve, the guard member comprising:a scaffold wherein the scaffold defines at least a partial an anulus around a central point the anulus comprising an outer radius and an inner radius; anda cover disposed around the scaffold covering at least a portion of an area between the inner radius and the outer radius and comprising a hole positioned between the inner radiusDocket No.: TMTTM3-24264WO01and the outer radius and configured allow a coil of the docking device to pass through the cover,wherein the guard member is movable between a compressed state and an expanded state and wherein the guard member is configured to be coupled at least partially to an outflow side of a first coil region of the coil.

19. A guard member, for a docking device for securing a prosthetic implant at a native valve, the guard member comprising:a scaffold wherein the scaffold defines at least a partial an anulus around a central point the anulus comprising an inner radius and an outer radius; anda bend portion disposed on the scaffold and extending inward towards the central point wherein the bend portion is configured to wrap around a coil of a first coil region of the docking device,wherein the guard member is movable between a compressed state and an expanded state and wherein the guard member is configured to be coupled at least partially to an outflow side of the coil of the first coil region.

20. A docking device for securing a prosthetic valve, the docking device comprising:a coil comprising:a longitudinal axis extending through a lumen of the coil from an inflow side to an outflow side;a first coil region configured to be disposed on the inflow side of a native annulus and to stabilize the coil relative to the native annulus;a second coil region extending from a distal end of the first coil region and comprising one or more helical turns and configured to be disposed on an outflow side of a native annulus and to receive a prosthetic valve; anda guard member comprising:a scaffold which defines at least a partial an anulus around a central point the anulus comprising an inner radius and an outer radius; anda cover disposed around the scaffold and comprising a hole positioned between the inner radius and the outer radius and configured allow the coil of the first coil region to pass through the cover.Docket No.: TMTTM3-24264WO0121. A docking device for securing a prosthetic valve, the docking device comprising:a first coil region configured to be disposed on an inflow side of a native annulus and to stabilize the docking device relative to the native annulus, wherein the first coil region defines a first circle; anda second coil region extending from a distal end of the first coil region and comprising one or more helical turns configured to be disposed on an outflow side of a native annulus and to receive a prosthetic valve wherein the second coil region defines a second circle,wherein prior to implantation of a prosthetic heart valve the first circle defines a first center point and a first radius and the second circle defines a second center point and a second radius, wherein the first center point is spatially offset from the second center point.

22. A docking device for securing a prosthetic valve, the docking device comprising:a first coil region configured to be disposed on an inflow side of a native annulus and to stabilize the docking device relative to the native annulus, wherein the first coil region defines a first longitudinal axis extending through a lumen of the first coil region from an inflow side to an outflow side; anda second coil region extending from a distal end of the first coil region and comprising one or more helical turns configured to be disposed on an outflow side of a native annulus and to receive a prosthetic valve wherein the second coil region defines a second longitudinal axis parallel to the first longitudinal axis,wherein the first longitudinal axis is offset from the second longitudinal axis such that when docking device is installed at the native annulus, the first coil region is configured to overlap a portion of the native annulus.

23. A docking device for securing a prosthetic valve, the docking device comprising:a first coil region configured to be disposed on an inflow side of a native annulus and configured to stabilize the docking device relative to the native annulus; anda second coil region extending from a distal end of the first coil region and comprising one or more helical turns configured to be disposed on an outflow side of a native annulus and to receive a prosthetic valve wherein the second coil region defines aDocket No.: TMTTM3-24264WO01longitudinal axis extending through a lumen of the second coil region from an inflow side to an outflow side,wherein each helical turn of the second coil region lies substantially within a nominal radius about the longitudinal axis, wherein a portion of the first coil region extends radially outward from the nominal radius of the second coil region, and wherein a proximal end portion of the first coil region is disposed at the nominal radius relative to the longitudinal axis.

24. A guard member for a docking device for securing a prosthetic implant at a native valve, the guard member comprising:a scaffold comprising a spine;a cover disposed around the scaffold; anda marker coupled to the scaffold,wherein the guard member is movable between a compressed state and an expanded state.

25. The guard member of claim 24, wherein the marker is a 3D marker.

26. The guard member of any one of claims 24-25, wherein the marker is a spherical marker.

27. The guard member of any one of claims 24-26, wherein the marker comprises a through-hole.

28. The guard member of any one of claims 24-27, wherein the scaffold comprises a medial terminal lobe and the marker is coupled to the medial terminal lobe.

29. The guard member of any one of claims 24-28, wherein the scaffold comprises a retention feature and the marker is coupled to the retention feature.

30. The guard member of claim 29, wherein the retention feature is formed out of a unitary piece with the scaffold.Docket No.: TMTTM3-24264WO0131. The guard member of claim 30, wherein the retention feature is positioned out of a plane defined by the scaffold.

32. The guard member of any one of claims 30-31, wherein the marker is coined within the retention feature.

33. The guard member of any one of claims 28-32, wherein the cover defines a pocket around the medial terminal lobe of the scaffold and the marker is positioned inside the pocket.

34. An assembly comprising the guard member of any one of claims 24-33, and further comprising a coil configured to receive a prosthetic heart valve.

35. The assembly of claim 34, further comprising a prosthetic heart valve implanted within a lumen of the coil.

36. A method comprising:delivering the assembly of any one of claims 34-35 to a native valve; and deploying the assembly at an annulus of the native valve,wherein the assembly remains in an axially-elongate configuration when delivering the assembly and moves to a deployed orientation after the docking device is deployed.

37. The method of claim 36, wherein the coil comprises a first coil region and a second coil region, further comprising positioning the assembly such that a portion where the first coil region and the second coil region meet is positioned where the coil crosses the annulus.

38. The method of any one of claims 36-37, wherein the coil crosses the annulus at a mitral valve medial commissure.

39. A method comprising:delivering a docking device comprising a coil and a guard member to a native annulus; andDocket No.: TMTTM3-24264WO01positioning a marker on an atrial side of the native annulus wherein the marker is coupled to the guard member.

40. The method of claim 39, wherein the guard member comprises a medial terminal lobe and the marker is positioned on the medial terminal lobe.

41. The method of any one of claims 39-40, further comprising determining a clocking position of the docking device based on a position of the marker.

42. The method of any one of claims 39-41, further comprising deploying a prosthetic heart valve within the docking device.

43. A method for assembling a guard member for a docking device, the method comprising:forming a spine out of a first piece of material:forming a plurality of arms out of a second piece of material; andattaching the plurality of arms to the spine,wherein the spine is a curved spine, and wherein the arms are attached to the spine such that the amis extend radially outward from the spine.

44. A guard member for a docking device for securing a prosthetic implant at a native valve, the guard member comprising:a scaffold comprising a spine and an ami extending radially outward from the spine; anda flap fitted over the scaffold; anda plurality of stitches,wherein the flap is attached to the arm by the plurality of stitches, wherein the plurality of stitches extend radially outward along the arm.

45. The guard member of claim 44, wherein the arm is one of a plurality of arms and wherein the plurality of stitches attaches the flap to each arm of the plurality of arms.Docket No.: TMTTM3-24264WO0146. The guard member of any one of claims 44-45, wherein the guard member comprises a first side configured to be positioned on an annuls of a native valve and wherein the plurality of stitches on the first side extend parallel to the arm.

47. A method for assembling a guard member for a docking device, the method comprising:fitting a flap over a scaffold, wherein the scaffold comprises a spine and an arm extending radially outward from the spine; andattaching the flap to the scaffold by forming a plurality of stitches spaced along the arm.

48. The method of claim 47, wherein the guard member comprises a first side configured to be positioned on an annuls of a native valve and wherein forming a plurality of stitches spaced along the arm comprises disposing the stitches on the first side so that they are parallel to the arm.

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