Patent Application
20220257367
The present disclosure relates to implantable, mechanically expandable prosthetic devices, such as prosthetic heart valves, and to methods and delivery assemblies for, and including, such devices.
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 (e.g., 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 (e.g., 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.
Prosthetic heart valves that rely on a mechanical actuator for expansion can be referred to as “mechanically expandable” prosthetic heart valves. Mechanically expandable prosthetic heart valves can provide one or more advantages over self-expandable and balloon-expandable prosthetic heart valves. For example, mechanically expandable prosthetic heart valves can be expanded to various diameters. Mechanically expandable prosthetic heart valves can also be compressed after an initial expansion (e.g., for repositioning and/or retrieval).
Despite the recent advancements in percutaneous valve technology, there remains a need for improved transcatheter heart valves and delivery devices for such valves.
Embodiments of improved prosthetic implant delivery assemblies and frames therefor are disclosed herein, as well as related methods and devices for such assemblies. In several embodiments, the disclosed assemblies are configured for delivering replacement heart valves into a heart of a patient.
In a representative embodiment, an implantable prosthetic device can comprise a frame movable between a radially compressed and a radially expanded configuration. The frame can comprise a first strut having a first locking feature disposed on a radially facing inner surface of the strut and a second strut having a second locking feature disposed on a radially facing outer surface of the strut. The first and second locking features can engage each other so as to allow pivoting of the first and second struts relative to one another in a first direction upon radial expansion of the frame and resist pivoting of the first and second struts relative to one another in a second direction to resist radial compression of the frame.
In some embodiments, the first locking feature is disposed at a first end portion of the first strut, and the second locking feature is disposed at a first end portion of the second strut.
In some embodiments, the first locking feature comprises a first toothed portion and the second locking feature comprises a second toothed portion. The first and second struts can be pivotably coupled to one another at a junction, and the first and second toothed portions can be arrayed circumferentially around at least a portion of the junction. The first toothed portion can comprise a first set of surfaces extending perpendicularly to the radially facing inner surface of the first strut and a second set of surface extending at an angle less than 90° relative to the radially facing inner surface of the strut, and the second toothed portion can comprise a third set of surfaces extending perpendicularly to the radially facing outer surface of the second strut and a fourth set of surfaces extending at an angle less than 90° relative to the radially facing outer surface of the strut.
In some embodiments, the first locking feature is formed integrally with the first strut and the second locking feature is formed integrally with the second strut.
In some embodiments, the first and second struts are pivotably coupled to one another at a junction by a fastener extending through the junction, and the fastener comprises a biasing member configured to bias the first and second struts against one another. The fastener can have a head portion and a shaft, the shaft extending through the first and second struts, and the biasing member can be disposed around the shaft at a location between the head portion and the first and second struts.
In some embodiments, the first and second locking features are movable from a disengaged position to an engaged position. When in the disengaged position the first and second struts can move relative to one another in the first and second directions. When in the engaged position the first and second locking features are rotationally aligned with one another and when in the disengaged position the first and second locking features are rotationally offset from one another.
In another representative embodiment, an implantable prosthetic device can comprise a frame movable between a radially compressed and a radially expanded configuration. The frame can comprise a first set of struts and a second set of struts. Each strut of the second set of struts can be pivotally connected at one or more junctions to at least one strut of the first set of struts. At least one strut of the first set of struts and at least one strut of the second set of struts can comprise first and second locking features, respectively, at a junction where the at least one strut of the first set of struts and the at least one strut of the second set of struts are pivotally connected to each other. The first and second locking features can engage each other so as to allow pivoting of the struts of the first set relative to the struts of the second set in a first direction upon radial expansion of the frame and resist pivoting of the struts relative to one another in a second direction to resist radial compression of the frame.
In some embodiments, the first locking feature is a first toothed portion and the second locking feature is a second, correspondingly toothed portion.
In some embodiments, the first locking feature is disposed on a radially facing inner surface of the at least one strut of the first set of struts and the second locking feature is disposed on a radially facing outer surface of the at least one strut of the second set of struts.
In some embodiments, the first locking feature is formed integrally with the at least one strut of the first set of struts and the second locking feature is formed integrally with the at least one strut of the second set of struts.
In some embodiments, each strut comprises a plurality of segments coupled to one another by a plurality of intermediate segments, and the first locking feature is disposed on an intermediate segment of the at least one strut of the first set of struts and the second locking feature is disposed on an intermediate segment of the at least one strut of the second set of struts.
In some embodiments, each junction comprises a fastener extending through respective struts of the first and second sets of struts. Such embodiments can further comprise a biasing member configured to bias the radially facing inner surface of a respective strut of the first set of struts against the radially facing outer surface of a respective strut of the second set of struts.
In a representative embodiment, a method comprises inserting a distal end of a delivery apparatus into the vasculature of a patient. The delivery apparatus can be releasably coupled to a prosthetic valve movable between a radially compressed and a radially expanded configuration. The prosthetic valve can comprise a frame having a first set of struts pivotably coupled to a second set of struts, each strut having a radially facing inner surface, and a radially facing outer surface. The method further comprises advancing the prosthetic valve to a selected implantation site and radially expanding the prosthetic valve such that a first locking feature disposed on a radially facing inner surface of at least one of the first set of struts engages a second locking feature disposed on a radially facing outer surface of at least one of the second set of struts to lock the frame in the radially expanded configuration.
In some embodiments, radially expanding the prosthetic valve comprises pivoting the first set of struts away from the second set of struts such that the first and second locking features rotate toward one another and engage one another.
In some embodiments, the first locking feature comprises a first plurality of teeth and the second locking feature comprises a second plurality of teeth and engagement of the first plurality of teeth with the second plurality of teeth prevents radially compression of the prosthetic valve.
In a representative embodiment, an implantable prosthetic device comprises a frame movable between a radially compressed and a radially expanded configuration, the frame comprising an inflow end portion and an outflow end portion and at least one expansion and locking mechanism. The expansion and locking mechanism can comprise a first member coupled to the frame at a first location, the first member comprising a pawl, and a second member coupled to the frame at a second location spaced apart from the first location, the second member extending at least partially into the first member and comprising a rack having a plurality of teeth arrayed along a length of the second member. Engagement of the pawl with the rack allows movement in a first direction to allow radial expansion of the frame and prevents movement in a second direction to prevent radial compression of the frame. The first member can comprise a sleeve and the teeth of the second member are housed in the sleeve.
In some embodiments, the first and second members have a rectangular or square cross-sectional profile in a plane perpendicular to a length of the expansion and locking mechanism.
In some embodiments, the pawl is biased toward the plurality of teeth.
In some embodiments, the prosthetic device further comprises a retaining member disposed between the pawl and the second member, the retaining member configured to selectively retain the pawl from engaging the rack.
In some embodiments, the entirety of the rack can be enclosed within the sleeve.
In a representative embodiment, an assembly can comprise a prosthetic heart valve and a delivery apparatus. The prosthetic heart valve can comprise a frame movable between a radially compressed and a radially expanded configuration, the frame comprising an inflow end portion and an outflow end portion, and at least one expansion and locking mechanism comprising a first member coupled to the frame at a first location, the first member comprising a pawl, and a second member coupled to the frame at a second location spaced apart from the first location, the second member extending at least partially into the first member and comprising a rack comprising a plurality of teeth, wherein the first member is shaped to enclose the rack. The delivery apparatus can comprise a handle, a first actuation member extending from the handle and coupled to the first member, the first actuation member configured to apply a distally directed force to the first member, and a second actuation member extending from the handle and coupled to the second member, the second actuation member configured to apply a proximally directed force to the second member. The prosthetic heart valve can be is radially expandable from the radially compressed configuration to the radially expanded configuration upon application of the distally directed force and the proximally directed force to the prosthetic heart valve via the first and second actuation members, respectively. Expansion of the prosthetic valve can cause movement of the first and second members relative to one another such that the pawl engages the teeth of the rack allowing movement of the first and second members in a first direction to allow radial expansion of the frame and preventing movement in a second direction to prevent radial compression of the frame.
In another representative embodiment, an implantable prosthetic device can comprise a frame being radially expandable and compressible between a radially compressed state and a radially expanded state, the frame comprising a first set of first struts, a second set of second struts, and a third set of third struts, the frame having a distal end and a proximal end. The first struts can be pivotably connected to each other at a plurality of distal and proximal apices at the distal and proximal ends of the frame, respectively. The second struts can be pivotably connected to each other at a plurality of distal and proximal apices at the distal and proximal ends of the frame, respectively. The third struts can be pivotably connected to each other at a plurality of distal and proximal apices at the distal and proximal ends of the frame, respectively. The first struts can be pivotably connected to the second and third struts at junctions between the distal and proximal ends of the frame. The second struts can be pivotably connected to the first and third struts at junctions between the distal and proximal ends of the frame. At least one expansion mechanism can be coupled to the frame at a pair of a distal apex and a proximal apex formed by the first struts. At least one locking mechanism can be coupled to the frame at a pair of axially spaced junctions, each of which is formed by struts of different sets. A plurality of commissure posts can be coupled to the frame at respective junctions. A leaflet assembly comprising a plurality of leaflets can be arranged to form a plurality of commissures coupled to respective commissure posts.
In another representative embodiment, an implantable prosthetic device can comprise a frame movable between a radially compressed and a radially expanded configuration, the frame comprising an inflow end portion and an outflow end portion, and at least one expansion and locking mechanism. Each expansion and locking mechanism can comprise a first member coupled to the frame at a first location, a second member coupled to the frame at a second location spaced apart from the first location, the second member extending at least partially into the first member and comprising a rack having a plurality of teeth arrayed along a length of the second member, and a locking member coupled to the first member via one or more protrusions extending from the second member into the first member, the locking member being biased toward the plurality of teeth. Engagement of the locking member with the rack can allow movement in a first direction to allow radial expansion of the frame and can prevent movement in a second direction to prevent radial compression of the frame.
In some embodiments, the locking member comprises one or more apertures extending at least partially through a thickness of the locking member, and wherein the one or more protrusions extend into the apertures.
In some embodiments, the one or more protrusions have a substantially cylindrical shape.
In some embodiments, the one or more protrusions have a hemispherical shape.
In some embodiments, the locking member comprises a locking tooth extending toward the rack and configured to engage the plurality of teeth.
In some embodiments, the locking member comprises a disengagement tooth extending axially from a proximal edge of the locking member. In some such embodiments, the prosthetic device further comprises a disengagement member configured to selectively engage the disengagement tooth to retain the locking member from engaging the rack.
In some embodiments, the locking member comprises a cutout defining a neck portion configured to bias the locking tooth radially against the rack. In some such embodiments, the neck portion is a first neck portion and wherein the locking member further comprises a second cutout defining a second neck portion configured to bias the locking tooth axially against the rack.
In some embodiments, the first member comprises a first engagement surface and the second member comprises a protrusion having a second engagement surface, and wherein the second engagement surface is configured to selectively abut the first engagement surface to prevent proximal movement of the second member past a predetermined point.
In some embodiments, the prosthetic device further comprises a stopper disposed on a distal end portion of the second member, the stopper sized to selectively abut a distal end portion of the first member to prevent proximal movement of the second member past a predetermined point. In some such embodiments, the distal end portion of the second member comprises a threaded portion and the stopper comprises a correspondingly threaded portion, and wherein rotation of the stopper in a first direction advances the stopper distally relative to the second member and rotation of the stopper in a second direction advances the stopper proximally relative to the second member.
In some embodiments, the first member has a rectangular cross-sectional profile in a plane perpendicular to a length of the expansion and locking mechanism.
In some embodiments, the first member comprises an inner bore having a first portion and a second portion, each having a first width, the first and second portions being separated by a neck portion having a second width smaller than the first width. In some such embodiments, the second member is sized to extend at least partially into the first portion of the inner bore.
In some embodiments, the first member comprises an opening in which the locking member is disposed. In some such embodiments, the first member comprises a ledge portion extending at least partially into the opening on which a portion of the locking member is disposed.
In another representative embodiment, a method of making an expansion and locking mechanism can comprise providing an outer member having an inner wall and an outer wall each comprising one or more first apertures having a first diameter, a first side wall, and a second side wall, the first side wall including an opening. The method can further comprise disposing a locking member within the opening, the locking member comprising one or more second apertures extending at least partially through a thickness of the locking member, the locking member can be disposed in the opening such that each second aperture aligns with a respective first aperture, and each second aperture can have a second diameter greater than the first diameter such that a respective lip portion is defined between each pair of first and second apertures. The method can further comprise using a punch member to apply force to a respective first aperture such that the lip portion deforms into the respective second aperture thereby securing the locking member to the outer member.
In some embodiments, the punch member is a cylindrical member having a third diameter greater than the first diameter and smaller than the second diameter.
In yet another representative embodiment, an implantable prosthetic device can comprise a frame movable between a radially compressed and a radially expanded configuration, the frame comprising an inflow end portion and an outflow end portion, and at least one expansion and locking mechanism. Each expansion and locking mechanism can comprise a first member coupled to the frame at a first location, the first member comprising a locking member, a second member coupled to the frame at a second location spaced apart from the first location, the second member extending at least partially into the first member and comprising a rack having a plurality of teeth arrayed along a length of the second member, and a stopper. The stopper can be disposed on an end portion of the second member and configured to prevent movement of the second member in a first direction past a predetermined point. Engagement of the locking member with the rack can allow movement in a first direction to allow radial expansion of the frame and prevent movement in a second direction to prevent radial compression of the frame.
In some embodiments, the stopper can comprise an annular nut sized to selectively abut a distal edge of the first member to retain the frame at a predetermined diameter.
In some embodiments, the end portion of the second member comprises a threaded portion and the stopper comprises a correspondingly threaded portion, and rotation of the stopper in a first direction advances the stopper in the first direction relative to the second member and rotation of the stopper in a second direction advances the stopper in the second direction relative to the second member.
In another representative embodiment, an implantable prosthetic device can comprise a frame movable between a radially compressed and a radially expanded configuration, the frame comprising an inflow end portion and an outflow end portion and at least one expansion and locking mechanism. Each expansion and locking mechanism can comprise a first member coupled to the frame at a first location, the first member comprising an aperture extending through a thickness of the first member, a second member coupled to the frame at a second location spaced apart from the first location, the second member extending at least partially into the first member, and a locking member coupled to the first member and being biased toward the second member. Engagement of the locking member with the second member allows movement in a first direction to allow radial expansion of the frame and prevents movement in a second direction to prevent radial compression of the frame. The aperture can be positioned such that a proximal edge of the second member can be viewed through the aperture when the prosthetic heart valve is in an assembled configuration.
In some embodiments, the first member has a rectangular cross-sectional profile in a plane perpendicular to a length of the expansion and locking mechanism, the first member comprising a first wall and a second wall, the first wall disposed radially outwardly of the second wall. In some such embodiments, the aperture extends through a thickness of the first wall.
In some embodiments, the first member comprises a commissure attachment portion and wherein the aperture is disposed distally relative to the commissure attachment portion.
In some embodiments, the aperture is positioned such that an apex of the locking tooth can be viewed through the aperture.
In some embodiments, the implantable device can further comprise a valvular structure including a plurality of leaflets, wherein each pair of adjacent leaflets is coupled to a respective expansion and locking mechanism at a respective commissure attachment portion to form a commissure. In some such embodiments, the aperture is positioned such that when the prosthetic device is in the radially expanded position, the commissure does not cover the aperture.
In some embodiments, the second member comprises a rack having a plurality of teeth arrayed along a length of the second member, and wherein the locking member comprises a locking tooth extending toward the rack and configured to engage the plurality of teeth.
In some embodiments, the locking member comprises a disengagement tooth extending axially from a proximal edge of the locking member. In some such embodiments, the implantable device can further comprise a disengagement member configured to selectively engage the disengagement tooth to retain the locking member from engaging the rack.
In some embodiments, the first member comprises a first engagement surface and the second member comprises a protrusion having a second engagement surface, and wherein the second engagement surface is configured to selectively abut the first engagement surface to prevent proximal movement of the second member past a predetermined point.
In some embodiments, the implantable device can further comprise a fastener extending radially outward from the first wall of the first member. In some such embodiments, the aperture is positioned distally adjacent to the fastener.
In some embodiments, the implantable device further comprises a fastener extending radially outward from a distal end portion of the second member.
In some embodiments, the implantable device further comprises a stopper disposed on a distal end portion of the second member, the stopper sized to selectively abut a distal end portion of the first member to prevent proximal movement of the second member past a predetermined point. In some such embodiments, the distal end portion of the second member comprises a threaded portion and the stopper comprises a correspondingly threaded portion, and wherein rotation of the stopper in a first direction advances the stopper distally relative to the second member and rotation of the stopper in a second direction advances the stopper proximally relative to the second member.
In some embodiments, the first member comprises an inner bore having a first portion and a second portion, each having a first width, the first and second portions being separated by a neck portion having a second width smaller than the first width. In some such embodiments, the second member is sized to extend at least partially into the first portion of the inner bore.
In some embodiments, the first member comprises an opening in which the locking member is disposed.
In some embodiments, the aperture is positioned such that a connection between the second member and an actuator of a delivery apparatus is visible.
In some embodiments, the frame comprises three expansion and locking mechanisms disposed circumferentially around the frame. In some such embodiments, the three expansion and locking mechanisms are spaced apart evenly from one another.
In another representative embodiment, an implantable prosthetic device can comprise a frame movable between a radially compressed and a radially expanded configuration, the frame comprising an inflow end portion and an outflow end portion, and at least one expansion and locking mechanism. Each expansion and locking mechanism can comprise a first member coupled to the frame at a first location, the first member having a first wall and a second wall and comprising an aperture extending through a thickness of the first wall, a second member coupled to the frame at a second location spaced apart from the first location, the second member extending at least partially into the first member, and a locking member coupled to the first member and being biased toward the second member. The implantable prosthetic device can further comprise a valvular structure comprising a plurality of leaflets, wherein each pair of adjacent leaflets is coupled to a respective expansion and locking mechanism at a respective commissure attachment portion to form a commissure. A respective aperture can be disposed distally adjacent each commissure.
In some embodiments, the valvular structure comprises three leaflets and three commissures.
In a representative embodiment, an assembly can comprise an implantable prosthetic device having a frame movable between a radially compressed and a radially expanded configuration, the frame comprising an inflow end portion and an outflow end portion, and at least one expansion and locking mechanism. The expansion and locking mechanism can comprise a first member coupled to the frame at a first location, the first member comprising an aperture extending through a thickness of the first member, a second member coupled to the frame at a second location spaced apart from the first location, the second member extending at least partially into the first member, and a locking member coupled to the first member and being biased toward the second member. The assembly can further comprise a delivery apparatus comprising a handle, a first actuation member extending from the handle and coupled to the first member, the first actuation member configured to apply a distally directed force to the first member, and a second actuation member extending from the handle and coupled to the second member, the second actuation member configured to apply a proximally directed force to the second member. The connection between the second member and the second actuation member can be visible through the aperture.
In some embodiments, the second actuation member extends at least partially into the first member.
In some embodiments, a distal end portion of the second actuation member comprises an engagement member. In some such embodiments, a proximal end portion of the second member comprises a bore into which the engagement member can extend. In some such embodiments, the engagement member comprises an external threaded surface configured to couple a correspondingly threaded surface of the bore. In other such embodiments, the engagement member comprises a magnet, and the inner bore comprises a correspondingly magnetic material.
In some embodiments, a distal end portion of the first actuation member is configured to abut a proximal end portion of the first member.
In some embodiments, the first member has a rectangular cross-sectional profile in a plane perpendicular to a length of the expansion and locking mechanism, the first member comprising a first wall and a second wall, the first wall disposed radially outwardly of the second wall.
In some embodiments, the aperture extends through a thickness of the first wall.
In some embodiments, the first member comprises a commissure attachment portion and wherein the aperture is disposed distally relative to the commissure attachment portion.
In some embodiments, the prosthetic device can further comprise a valvular structure including a plurality of leaflets, wherein each pair of adjacent leaflets is coupled to a respective expansion and locking mechanism at a respective commissure attachment portion to form a commissure. In some such embodiments, the aperture is positioned such that when the prosthetic device is in the radially expanded position, the commissure does not cover the aperture.
In some embodiments, the expansion and locking mechanism further comprises a fastener extending radially outward from the first wall of the first member.
In some embodiments, the aperture is positioned distally adjacent to the fastener.
In a representative embodiment, an implantable prosthetic device can comprise a frame movable between a radially compressed and a radially expanded configuration, the frame comprising an inflow end portion and an outflow end portion, and at least one expansion and locking mechanism. The expansion and locking mechanism can comprise a first member coupled to the frame at a first location, the first member comprising a commissure opening extending through a thickness of the first member, a second member coupled to the frame at a second location spaced apart from the first location, the second member extending at least partially into the first member, and a locking member coupled to the first member, the locking member configured to engage the second member to allow movement in a first direction to allow radial expansion of the frame and prevent movement in a second direction to prevent radial compression of the frame. The prosthetic device can further comprise a valvular structure comprising a plurality of leaflets each including one or more tabs, wherein tabs of adjacent leaflets are disposed within the commissure opening to couple the valvular structure to the frame.
In some embodiments, the commissure opening comprises a first aperture and a second aperture forming a channel between them, and wherein the channel has at least one angled surface corresponding to one or more angled edges of the plurality of leaflets.
In some embodiments, the first member comprises a bore extending longitudinally along the length of the first member, and wherein the bore is offset from a longitudinal axis of the first member.
In some embodiments, each expansion and locking mechanism further comprises a wedge disposed between adjacent tabs to help couple the valvular structure to the frame.
In some embodiments, the portion of the first member comprising the commissure opening extends past the outflow end portion of the frame.
In some embodiments, the first member is coupled to the frame via a fastener extending from a surface of the first member. In some such embodiments, the commissure opening is closer to the outflow end portion of the frame than the fastener.
In some embodiments, the second member is coupled to the frame via a fastener extending from a surface of the second member.
In some embodiments, the commissure opening extends to an outflow edge of the first member. In some such embodiments, the commissure opening defines a first extension and a second extension in the outflow end portion of the first member with the commissure opening between them. In some embodiments, the first member comprises a bore extending along a length of the first member and disposed in the second extension.
In some embodiments, the first member comprises an angled portion such that an outflow end portion of the expansion and locking mechanism has a first width and an inflow end portion has a second width narrower than the first width.
In some embodiments, the first member comprises one or more rounded radially inner edges.
In some embodiments, the first member comprises one or more rounded radially outer edges configured to correspond to a radially inner surface of the frame.
In some embodiments, the first member comprises one or more chamfered radially inner edges.
In some embodiments, the first member comprises one or more chamfered radially outer edges.
In a representative embodiment, a method of assembling a prosthetic valve can comprise providing a frame movable between a radially compressed and a radially expanded configuration, the frame comprising an inflow end portion and an outflow end portion, the frame including one or more expansion and locking mechanisms including an outer member comprising a commissure opening extending through a thickness of the outer member, an inner member, and a locking member. The method can further comprise inserting tabs of adjacent leaflets of a valvular structure into the commissure opening such that the tabs extend through the outer member, inserting a wedge between radially outer portions of the tabs to form a commissure assembly, and coupling the commissure assembly to the outer member.
In some embodiments, inserting the tabs into the commissure opening comprises inserting the tabs through a radially inner aperture in the outer member and then inserting the tabs at least partially through a radially outer aperture in the outer member.
In some embodiments, coupling the commissure assembly to the outer member comprises using one or more sutures.
In another representative embodiment, a method of assembling a prosthetic valve can comprise providing a frame movable between a radially compressed and a radially expanded configuration, the frame comprising an inflow end portion and an outflow end portion, the frame including one or more expansion and locking mechanisms including an outer member comprising a commissure opening extending through a thickness of the outer member and extending to an outflow edge of the outer member to form an outflow aperture, an inner member, and a locking member. The method can further comprise inserting a wedge between adjacent tabs of adjacent leaflets of a valvular structure and coupling the wedge to the tabs to form a commissure assembly, inserting the commissure assembly into the commissure opening by sliding the commissure assembly through the outflow aperture, and coupling the commissure assembly to the outer member.
In some embodiments, coupling the wedge to the tabs includes using one or more sutures.
In some embodiments, coupling the commissure assembly to the outer member includes using one or more sutures.
In a representative embodiment, an implantable prosthetic device can comprise a frame movable between a radially compressed and a radially expanded configuration, the frame comprising an inflow end portion and an outflow end portion, and at least one expansion and locking mechanism. The expansion and locking mechanism can comprise a first member coupled to the frame at a first location, the first member comprising an inner bore extending the length of the first member, the bore having a first portion and a second portion separated by a neck portion, a second member coupled to the frame at a second location spaced apart from the first location, the second member extending at least partially into the first portion of the bore, and a locking member comprising a pawl portion and a body portion, the locking member disposed within the second portion of the bore. Engagement of the locking member with the inner member allows movement in a first direction to allow radial expansion of the frame and prevents movement in a second direction to prevent radial compression of the frame.
In some embodiments, at least a portion of the second member has a semi-circular shape in cross-section comprising a curved surface and a flat surface.
In some embodiments, the body portion of the locking member has a semi-circular shape in cross-section comprising a curved surface and a flat surface.
In some embodiments, the flat surfaces of the second member and locking member are oriented toward one another.
In some embodiments, the flat surfaces of the second member and locking member are spaced apart from one another.
In some embodiments, the flat surfaces of the second member and locking member contact one another.
In some embodiments, the flat surfaces of the second member and locking member are coated with a lubricious coating.
In some embodiments, a side wall of the first member comprises an opening aligned with the pawl portion of the locking member such that the pawl portion can selectively deflect into the opening.
In some embodiments, the body portion of the locking member comprises one or more apertures and wherein the locking member is coupled to the first member via one or more protrusions extending from the first member into the apertures.
In another representative embodiment, an implantable prosthetic device can comprise a frame movable between a radially compressed and a radially expanded configuration, the frame comprising an inflow end portion and an outflow end portion, and at least one expansion and locking mechanism. The expansion and locking mechanism can comprise a first member coupled to the frame at a first location, a second member coupled to the frame at a second location spaced apart from the first location, the second member extending at least partially into the first member, and a locking member coupled to the first member via one or more lateral extensions extending from the first member into a recess of the locking member. Engagement of the locking member with the inner member allows movement in a first direction to allow radial expansion of the frame and prevents movement in a second direction to prevent radial compression of the frame.
In some embodiments, the second member comprises a rack having a plurality of teeth arrayed along a length of the second member, and wherein the locking member comprises a locking tooth extending toward the rack and configured to engage the plurality of teeth.
In some embodiments, the lateral extensions have a rectangular shape.
In some embodiments, the lateral extensions have a length along a longitudinal axis of the outer member greater than a width of the lateral extensions.
In some embodiments, the lateral extensions have a length along a longitudinal axis of the outer member less than a width of the lateral extensions.
In some embodiments, the recess has a rectangular shape corresponding to the rectangular shapes of the lateral extensions.
In some embodiments, the recess has a depth corresponding to a thickness of the lateral extensions.
In some embodiments, the lateral extensions are aligned with one another along a length of the first member.
In some embodiments, the lateral extensions are offset from one another along a length of the first member.
In a representative embodiment, a method of making an expansion and locking mechanism can comprise providing an outer member having an inner wall, an outer wall, a first side wall, and a second side wall, the first side wall including an opening and the inner wall and outer wall each comprising one or more bendable lateral extensions aligned with a first portion of the opening. The method can further comprise disposing a locking member within the opening, the locking member comprising a pawl portion and a body portion including a recess, the locking member being disposed within the opening such that the recess is aligned with the lateral extensions, and applying a force to each lateral extension such that the lateral extension deforms into the recess, thereby securing the locking member to the outer member.
In some embodiments, the lateral extensions have a rectangular shape.
In some embodiments, the lateral extensions have a length along a longitudinal axis of the outer member greater than a width of the lateral extensions.
In some embodiments, the lateral extensions have a length along a longitudinal axis of the outer member less than a width of the lateral extensions
In some embodiments, when the lateral extensions are in an undeformed position they extend perpendicular to the first side wall.
In some embodiments, when the lateral extensions are in a deformed position they extend parallel to the first side wall.
In a representative embodiment, an implantable prosthetic device can comprise a frame movable between a radially compressed and a radially expanded configuration, the frame comprising an inflow end portion and an outflow end portion, and at least one expansion and locking mechanism. The expansion and locking mechanism comprising a first member coupled to the frame at a first location, the first member comprising an opening including one or more lateral extensions, a second member coupled to the frame at a second location spaced apart from the first location, the second member extending at least partially into the first member, and a locking member comprising a pawl portion and a body portion, the body portion including first and second angled surfaces, the locking member being coupled to the first member via the one or more lateral extensions engaging the angled surfaces. The locking member can be configured to engage the second member to allow movement in a first direction to allow radial expansion of the frame and prevent movement in a second direction to prevent radial compression of the frame.
In some embodiments, the body portion of the locking member has a triangular shape with chamfered corners in cross-section.
In some embodiments, the angled surfaces are disposed at an angle relative to an inner wall of the locking member. In some embodiments, the inner wall is disposed nearer to the longitudinal axis of the outer member than the angled surfaces. In some embodiments, the angle is a 45 degree angle.
In some embodiments, the second member comprises a rack having a plurality of teeth arrayed along a length of the second member, and wherein the locking member comprises a locking tooth extending toward the rack and configured to engage the plurality of teeth.
In some embodiments, the lateral extensions have a rectangular shape.
In some embodiments, each lateral extension comprises a chamfered edge portion. In some embodiments, the chamfered edge portions are configured such that when the lateral extensions are engaged with the angled surfaces the chamfered edge portions do not extend past the angled surfaces.
In a representative embodiment, a method of making an expansion and locking mechanism can comprise providing a first member having an inner wall, an outer wall, a first side wall comprising an opening, and a second side wall, the inner and outer walls each comprising a lateral extension, and disposing a locking member within the opening, the locking member comprising a body portion including first and second angled surfaces, wherein the locking member is disposed within the opening such that each angled surface aligns with a respective lateral extension. The method can further comprise applying force to the lateral extensions such that the lateral extensions deform to engage the angled surfaces thereby securing the locking member to the first member.
In some embodiments, the force applied is directed toward a longitudinal axis of the first member.
In another representative embodiment, an implantable prosthetic device can comprise a frame movable between a radially compressed and a radially expanded configuration, the frame comprising an inflow end portion and an outflow end portion and at least one expansion and locking mechanism. The expansion and locking mechanism can comprise a first member coupled to the frame at a first location, a second member coupled to the frame at a second location spaced apart from the first location, the second member extending at least partially into the first member, and a locking member comprising a pawl portion and a body portion, the body portion including first and second elongated recesses, the locking member being coupled to the first member via first and second protrusions extending from the first member into the first and second recesses. The locking member can be configured to to engage the second member to allow movement in a first direction to allow radial expansion of the frame and prevent movement in a second direction to prevent radial compression of the frame.
In some embodiments, the first and second elongated recesses each have a V-shape in cross-section. In some embodiments, the opening of the opening of each V-shape is oriented toward the side walls of the first member. In some embodiments, each protrusion has a V-shape that corresponds to the V-shape of a respective recess.
In some embodiments, the second member comprises a rack having a plurality of teeth arrayed along a length of the second member, and wherein the locking member comprises a locking tooth extending toward the rack and configured to engage the plurality of teeth.
In a representative embodiment, a method of making an expansion and locking mechanism can comprise providing a first member having an inner wall, an outer wall, a first side wall including an opening, and a second side wall, and disposing a locking member within the opening, the locking member an outer wall and an inner wall, the outer and inner walls each comprising an elongated recess. The method can further comprise applying a force to the inner and outer walls of the first member such that the inner and outer walls deform to form protrusions that extend into respective recesses thereby securing the locking member to the first member.
In some embodiments, the force applied is directed inwardly toward a longitudinal axis of the first member.
In another representative embodiment, an implantable prosthetic device can comprise a frame movable between a radially compressed and radially expanded configuration, the frame comprising an inflow end portion and an outflow end potion and at least one expansion and locking mechanism. The expansion and locking mechanism can comprise a first member coupled to the frame at a first location via a first fastener, the first fastener comprising a body portion and a flanged end portion, a second member coupled to the frame at a second location via a second fastener, the second fastener comprising a body portion and a flanged end portion, and a locking member coupled to the first member. The body portions of the first and second fasteners can extend through one or more apertures in the frame, and the flanged end portions can be sized to retain the first and second fasteners within the apertures.
In some embodiments, each flanged end portion is formed by radial riveting.
In some embodiments, each fastener is a solid piece of material.
In some embodiments, each fastener further comprises a base portion.
In some embodiments, the first fastener is formed integrally with the first member.
In some embodiments, the body portion of the first fastener extends through an aperture in a wall of the first member.
In a representative embodiment, a method of making a prosthetic valve can comprise providing a frame movable between a radially compressed and a radially expanded configuration, the frame comprising a plurality of struts each including one or more apertures, disposing an expansion and locking mechanism comprising a first member having a first fastener such that the first fastener extends through one or more apertures at a first location, and radially riveting the first fastener to form a first flanged end portion configured to retain the first fastener within its respective apertures, thereby coupling the expansion and locking mechanism to the frame.
In some embodiments, the expansion and locking mechanism further comprises a second member having a second fastener, and wherein the method further comprises disposing the expansion and locking mechanism such that the second fastener extends through one or more apertures at a second location spaced apart from the first location along a longitudinal axis of the frame, and radially riveting the second fastener to form a second flanged end portion configured to retain the second fastener within its respective apertures.
In another a representative embodiment, an expansion and locking mechanism can comprise an outer member comprising a first wall and a second wall, the first wall comprising an opening extending through the first wall, the opening comprising a main portion, a guide portion, and an entry portion, and a fastener having a base portion and a body portion, the body portion having one or more recesses configured such that when the recesses are aligned with the guide portion the fastener can slide along the guide portion and into the main opening and when the recesses are offset from the guide portion the fastener is retained within the main portion.
In some embodiments, the recesses are configured such that the portion of the body portion on which the recesses are disposed has a non-circular shape in cross-section.
In some embodiments, the main portion of the opening has a first width greater than a second width of the guide portion.
In some embodiments, the entry portion has a width corresponding to the width of the base portion of the fastener.
In a representative embodiment, a method of making an expansion and locking mechanism can comprise deforming a tubular member including an inner bore extending along the length of the tubular member such that it forms an oval shape in cross-section having first, second, third, and fourth walls, and cutting a fastener opening and inflow end cutout in the first wall and a locking member opening in the second wall. The method can further comprise disposing a locking member including a first end portion comprising a pawl and a second end portion within the locking member opening, disposing a fastener within the fastener opening, and disposing an inner member at least partially within the inner bore of the tubular member.
In some embodiments, the method further comprises deforming the first and third walls to form elongated indentations configured to retain the locking member within the locking member opening.
In some embodiments, the fastener opening comprises a main portion having a first width and a guide portion having a second width narrower than the first width. In some embodiments, disposing the fastener within the fastener opening comprises aligning one or more recesses in the fastener with the guide portion, sliding the fastener through the guide portion into the main portion, and rotating the fastener within the main portion such that the recesses are offset from the guide portion.
In some embodiments, the method can further comprise deforming the guide portion once the fastener is disposed within the main portion.
In some embodiments, the method can further comprise cutting a commissure opening in the third wall of the tubular member to form two deflectable portions, and bending the deflectable portions toward the first wall to form first and second commissure posts.
In another representative embodiment, a method of making an expansion and locking mechanism comprises deforming a sheet of material having first and second edges to form an elongated member having a substantially rectangular shape with rounded edges in cross-section, the elongated member comprising an inner bore extending along the length of the elongated member and a slot extending along the length of the elongated member defined by the first and second edges, and cutting a fastener opening and inflow end cutout in a first wall of the elongated member and a locking member opening in a second wall. The method can further comprise disposing a locking member including a first end portion comprising a pawl and a second end portion within the locking member opening, disposing a fastener within the fastener opening, and disposing an inner member at least partially within the inner bore of the elongated member.
In some embodiments, the fastener opening and the inflow end cutout incorporate at least a portion of the slot.
In some embodiments, the method further comprises deforming the first and third walls to form elongated indentations configured to retain the locking member within the locking member opening.
In some embodiments, the fastener opening comprises a main portion having a first width and a guide portion having a second width narrower than the first width.
In some embodiments, disposing the fastener within the fastener opening comprises aligning one or more recesses in the fastener with the guide portion, sliding the fastener through the guide portion into the main portion, and rotating the fastener within the main portion such that the recesses are offset from the guide portion. In some embodiments, the method further comprises cutting a commissure opening in the third wall of the tubular member to form two deflectable portions, and bending the deflectable portions toward the first wall to form first and second commissure posts.
The foregoing and other objects, features, and advantages of the disclosure will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
Described herein are examples of prosthetic implant delivery assemblies and components thereof which can improve a physician's ability to control the size of a mechanically-expandable prosthetic implant, such as prosthetic valves (e.g., prosthetic heart valves or venous valves), stents, or grafts, as well as facilitate separation of the prosthetic implant from the delivery assembly, during the implantation procedure. The present disclosure also provides frames for use with such prosthetic implants. The frames can comprise locking mechanisms configured to hold the frame in an expanded configuration when the implant is expanded at a selected delivery site within a patient.
Prosthetic valves disclosed herein can be radially compressible and expandable between a radially compressed configuration and a radially expanded configuration. Thus, the prosthetic valves can be crimped on an implant delivery apparatus in the radially compressed configuration during delivery, and then expanded to the radially expanded configuration once the prosthetic valve reaches the implantation site.
In the depicted embodiments, the first end 14 is an inflow end and the second end 16 is an outflow end. The outflow end 16 can be coupled to a delivery apparatus for delivering and implanting the prosthetic valve within the native aortic valve is a transfemoral, retrograde delivery approach. Thus, in the delivery configuration of the prosthetic valve, the outflow end 16 is the proximal-most end of the prosthetic valve. In other embodiments, the inflow end 14 can be coupled to the delivery apparatus, depending on the particular native valve being replaced and the delivery technique that is used (e.g., trans-septal, transapical, etc.). For example, the inflow end 14 can be coupled to the delivery apparatus (and therefore is the proximal-most end of the prosthetic valve in the delivery configuration) when delivering the prosthetic valve to the native mitral valve via a trans-septal delivery approach.
The prosthetic valve 10 can also include a valvular structure 18 which is coupled to the frame 12 and configured to regulate the flow of blood through the prosthetic valve 10 from the inflow end to the outflow end. The prosthetic valve 10 can further include a plurality of actuators 20 mounted to and equally spaced around the inner surface of the frame 12. Each of the actuators 20 can be configured to form a releasable connection with one or more respective actuators of a delivery apparatus, as further described below.
The valvular structure 18 can include, for example, a leaflet assembly comprising one or more leaflets 22 (three leaflets 22 in the illustrated embodiment) made of a flexible material. The leaflets 22 of the leaflet assembly can be made from in whole or part, biological material, bio-compatible synthetic materials, or other such materials. Suitable biological material can include, for example, bovine pericardium (or pericardium from other sources). The leaflets 22 can be arranged to form commissures 24, which can be, for example, mounted to respective actuators 20. Further details regarding transcatheter prosthetic heart valves, including the manner in which the valvular structure can be coupled to the frame 12 of the prosthetic valve 10, can be found, for example, in U.S. Pat. Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, and 8,652,202, and U.S. Patent Application Publication No. 2018/0325665, all of which are incorporated herein by reference in their entireties.
In some embodiments, the prosthetic valve 10 can include a plurality of commissure support elements configured as commissure clasps or clamps 26. In the illustrated configuration, the prosthetic valve includes a commissure clamp 26 positioned at each commissure 24 and configured to grip adjacent portions of two leaflets 22 at each commissure 24 at a location spaced radially inwardly of the frame 12. Each clamp 26 can be mounted on an actuator 20 as shown. In alternative embodiments, the commissure supports elements (such as clamps 26) can be mounted to the struts 28 of the frame, or alternatively, the commissures 24 can be mounted (e.g., sutured) directly to the struts of the frame. Further details of the commissure clamps 26 and other techniques for mounting the commissures of a valve assembly to a frame can be found in U.S. Patent Application Publication No. 2018/0325665.
Although not shown, the prosthetic valve 10 can also include one or more skirts or sealing members. For example, the prosthetic valve 10 can include an inner skirt mounted on the inner surface of the frame. The inner skirt can function as a sealing member to prevent or decrease perivalvular leakage, to anchor the leaflets 22 to the frame, and/or to protect the leaflets against damage caused by contact with the frame during crimping and during working cycles of the prosthetic valve. The prosthetic valve 10 can also include an outer skirt mounted on the outer surface of the frame 12. The outer skirt can function as a sealing member for the prosthetic valve by sealing against the tissue of the native valve annulus and helping to reduce paravalvular leakage past the prosthetic valve. The inner and outer skirts can be formed from any of various suitable biocompatible materials, including any of various synthetic materials (e.g., PET) or natural tissue (e.g., pericardial tissue). The inner and outer skirts can be mounted to the frame using sutures, an adhesive, welding, and/or other means for attaching the skirts to the frame.
The frame 12 can be made of any of various suitable materials, such as stainless steel, a cobalt chromium alloy, or a nickel titanium alloy (“NiTi”), for example Nitinol. Referring again to
In the illustrated embodiment, the struts 28 are pivotably coupled to one another at one or more pivot joints or junctions along the length of each strut. For example, in the illustrated configuration, each of the struts 28 can be formed with apertures (see e.g., apertures 114 in
In some embodiments, the frame 12 can be constructed by forming individual components (e.g., the struts and fasteners of the frame) and then mechanically assembling and connecting the individual components together. In other embodiments, the struts 28 are not coupled to each other with respective hinges but are otherwise pivotable or bendable relative to each other to permit radial expansion and contraction of the frame 12. For example, the frame 12 can be formed (e.g., via laser cutting, electroforming or physical vapor deposition) from a single piece of material (e.g., a metal tube). Further details regarding the construction of the frame and the prosthetic valve are described in U.S. Publication Nos. 2018/0153689; 2018/0344456; 2019/0060057 all of which are incorporated herein by reference. Additional examples of expandable prosthetic valves that can be used with the delivery apparatuses disclosed herein are described in U.S. Publication No. 2015/0135506 and 2014/0296962, which are incorporated herein by reference.
Referring still to
Each push-pull mechanism 32 can generally comprise an inner member 34, such as an inner tubular member, and an outer member 36 disposed about the inner member 34. The inner members 34 and the outer members 36 can be movable longitudinally relative to each other in a telescoping manner to radially expand and contract the frame 12, as further described in U.S. Publication Nos. 2018/0153689, 2018/0153689 and 2018/0325665 which are incorporated herein by reference. The inner members 34 can be, for example, rods, cables, wires, or tubes. The outer members 36 can be, for example, tubes or sheaths having sufficient rigidity such that they can apply a distally directed force to the frame without bending or buckling.
The inner members 34 can have distal end portions 34a coupled to the inflow end 14 of the frame 12 (e.g., with a coupling element such as a pin member 30). In the illustrated embodiment, each of the inner members 34 are coupled to the frame at respective apices 38 at the inflow end 14 of the frame 12. For example, the distal end portion 34a of each inner member 34 can be pivotably connected to the rivet or pin 30 that connects the two struts at the adjacent apex 38. The outer members 36 can be coupled to apices 38 at the outflow end 16 of the frame 12 at, for example, a mid-portion of the outer member 36, as shown in
The inner member 34 and the outer member 36 can telescope relative to each other between a fully contracted state (corresponding to a fully radially expanded state of the prosthetic valve) and a fully extended state (corresponding to a fully radially compressed state of the prosthetic valve). In the fully extended state, the inner member 34 is fully extended from the outer member 36. In this manner, the push-pull mechanisms 32 allow the prosthetic valve to be fully expanded or partially expanded to different diameters and retain the prosthetic valve in the partially or fully expanded state. It should be understood that the inner members 34 and the outer members 36 can be coupled to other locations on the frame to produce radial compression and expansion of the frame, so long as the inner member and outer member of each actuator are coupled at axial spaced pivot joints of the frame.
In use, a delivery apparatus (see, e.g., delivery apparatus 300 in
Once coupled to the delivery apparatus, the prosthetic valve 10 can then be radially collapsed (see e.g.,
The one or more actuator assemblies 150 can be components of a delivery apparatus and are configured to produce radial expansion and compression of the frame 102.
The screw 158 has an externally threaded surface that can engage an internally threaded surface of a nut or sleeve 162, which is affixed to the frame 102, such as at the distal end of the frame. When the actuator member 152 is rotated to screw the screw 158 into the sleeve 162, the actuator member 152 becomes connected to the distal end of the frame 102 such that proximal or distal motion of the actuator member 152 causes proximal or distal motion, respectively, of the distal end of the frame 102.
The cover tube 154 annularly surrounds the actuator member 152. The cover tube 154 can be connected to the actuator member 152 such that the actuator member 152 and the cover tube 154 rotate together and move axially together. The actuator member 152 and the cover tube 154 extend through the stopper 160, which can be affixed to a proximal end of the frame. The support tube 156 annularly surrounds the cover tube 154. The stopper 160 has an annular inner surface with an inner diameter larger than the outer diameter of the cover tube 154 and the screw 158 such that the cover tube 154 and the screw 158 can be retracted through the stopper 160 as the frame 102 is expanded and once the actuator is retracted proximally by the user to disconnect it from the frame. The stopper 160 is sized to abut or engage the distal end of the support tube 156 such that the support tube 156 is prevented from moving distally beyond the stopper 160.
In operation, prior to implantation in a patient, the screw 158 is threaded into the sleeve 162, thereby connecting the linear actuator assembly 150 to the frame 102. The frame 102 can then be placed in a radially collapsed state and the prosthetic valve and the distal end portion of the delivery apparatus can be inserted in a patient. Once the prosthetic valve 100 is at a desired implantation site, the frame 102 can be radially expanded as described herein.
To radially expand the frame 102, the support tube 156 is held firmly against the stopper 160. The actuator member 152 is then pulled in a proximal direction through the support tube 156, such as by pulling on the proximal end of the actuator member 152 or actuating a control knob on the handle that produces proximal movement of the actuator member 152. Because the support tube 156 is being held against the stopper 160, which is connected to the proximal end of the frame 102, the proximal end of the frame 102 is prevented from moving relative to the support tube 156 and the handle. As such, movement of the actuator member 152 in a proximal direction results in movement of the distal end of the frame 102 in a proximal direction causing the frame 102 to foreshorten axially and expand radially.
It should be understood that the frame 102 can also be radially expanded by pushing the proximal end of the frame toward the distal end of the frame by pushing the support tube 156 against the stopper 160 while keeping the actuator member 152 stationary relative to the handle, or alternatively, by simultaneously pushing the support tube 156 distally against the stopper 160 and pulling the actuator member 152 proximally.
After the frame 102 is expanded to a desired radially expanded size, one or more locking mechanisms can be actuated to lock the frame 102 in the desired radially expanded size, as discussed in further detail below (see
Further details of the actuator assemblies and various exemplary locking mechanisms can be found in U.S. Publication No. 2018/0153689. In some embodiments, the locking mechanism can be formed integrally with the struts of the prosthetic valve, such as described in more detail below.
Each strut 200 can have an offset, or zig-zag, pattern defined by a plurality of offset linear portions or segments 218. The linear segments 218 in the illustrated embodiment are arranged end-to-end relative to each other with adjacent ends interconnected to each other by intermediate segments 220. The strut 200 can have enlarged end portions 224 that form the apices at the inflow and outflow end of the frame. Each linear segment 218 is slightly laterally offset from an adjacent linear segment 218 in a direction perpendicular to the overall length of the strut 200 to provide the zig-zag pattern to the strut. Each of the intermediate segments 220 and end portions 224 can have a respective aperture 208 at its geometric center for receiving a fastener.
The amount of offset of each linear segment 218 relative to an adjacent linear segment along the length of the strut 200 can be constant such that an imaginary line 214 can pass through the aperture 208 of each intermediate segment 220 along the entire length of the strut. In alternative embodiments, the amount of offset between two adjacent linear segments 218 can vary along the length of the strut. For example, the amount of offset between linear segments 218 adjacent the outflow end of the frame can be greater than the amount of offset between linear segments 218 adjacent the inflow end of the frame, or vice versa.
The linear segments 218 can include at least substantially flat or linear opposing longitudinal edges 226a, 226b extending between curved or rounded edges 228 of the intermediate segments 220. In alternative embodiments, the opposing edges 228 of the intermediate segments 220 can be substantially flat or linear edges that extend at an angle between respective ends of the edges 226a, 226b of the liner segments 218.
As best shown in
In alternative embodiments, the width W1 of each linear segment 218 can vary along the length of a strut. For example, the width W1 of a linear segment 218 adjacent the inflow end of the frame can be greater than the width W1 of a linear segment 218 adjacent the outflow end of the frame, or vice versa. Further, where the width W1 of the linear segments 218 vary along the length of a strut 200, a linear segment can have one longitudinal edge 226a or 226b that is collinear with a longitudinal edge of an adjacent linear segment on the same side of the strut, while the other longitudinal edge 226a, 226b is laterally offset from the longitudinal edge of an adjacent linear strut on the same side of the strut. In other words, the strut 200 can have an overall zig-zag or offset pattern by virtue of the varying widths W1 of the linear segments.
The delivery apparatus 300 in the illustrated embodiment generally includes a handle 302, a first elongated shaft 304 (which comprises an outer shaft in the illustrated embodiment) extending distally from the handle 302, at least one actuator assembly 306 (e.g., three in the illustrated embodiment) extending distally through the outer shaft 304. The at least one actuator assembly 306 can be configured to radially expand and/or radially collapse the prosthetic valve 10 when actuated. Though the illustrated embodiment shows three actuator assemblies 306, it should be understood that more or fewer actuator assemblies can be present. In some embodiments, a distal end portion 316 of the shaft 304 can be sized to house the prosthetic valve in its radially compressed, delivery state during delivery of the prosthetic valve through the patient's vasculature. In this manner, the distal end portion 316 functions as a delivery sheath or capsule for the prosthetic valve during delivery,
The actuator assemblies 306 can be releasably coupled to the prosthetic valve 10. For example, in the illustrated embodiment, each actuator assembly 306 can be coupled to a respective actuator 20 of the prosthetic valve 10. Each actuator assembly 306 can comprise a first actuation member 308 and a second actuation member 309 (
The first actuation member 308 can be, for example, a sleeve, cylinder, shaft, tube, or other member configured to apply a distally directed forced to the prosthetic valve. The second actuation member 309 (
As mentioned above, each actuator 20 of the prosthetic valve 10 can generally comprise an inner member 34 and an outer member 36 disposed about the inner member 34. The inner members 34 and the outer members 36 can be movable longitudinally relative to each other in a telescoping manner to radially expand and contract the frame 12. In some embodiments, each first actuation member 308 of the delivery apparatus 300 can be releasably coupled to a respective outer member 36 of the actuator 20, and each second actuation member can be releasably coupled to a respective inner member 34 of the actuator 20. A user can actuate the actuator assemblies (e.g., using knob 312 as described below) thereby causing axial movement of the first actuation member 308 relative to the second actuation member. Movement of the actuator assemblies 306 can result in corresponding movement of the actuators 20 to radially expand and/or collapse the frame 12. Once the prosthetic valve 10 is fully expanded, it can be locked into position using one or more locking mechanisms and/or locking features, as described in more detail below.
The handle 302 of the delivery apparatus 300 can include one or more control mechanisms (e.g., knobs or other actuating mechanisms) for controlling different components of the delivery apparatus 300 in order to expand and/or deploy the prosthetic valve 10. For example, in the illustrated embodiment the handle 302 comprises first, second, and third knobs 310, 312, and 314.
The first knob 310 can be a rotatable knob configured to produce axial movement of the outer shaft 304 relative to the prosthetic valve 10 in the distal and/or proximal directions in order to deploy the prosthetic valve from the delivery sheath 316 once the prosthetic valve has been advanced to a location at or adjacent the desired implantation location with the patient's body. For example, rotation of the first knob 310 in a first direction (e.g., clockwise) can retract the outer sheath 304 proximally relative to the prosthetic valve 10 and rotation of the first knob 310 in a second direction (e.g., counter-clockwise) can advance the outer sheath 304 distally. In other embodiments, the first knob 310 can be actuated by sliding or moving the knob 310 axially, such as pulling and/or pushing the knob. In other embodiments, actuation of the first knob 310 (rotation or sliding movement of the knob 310) can produce axial movement of the actuator assemblies 306 (and therefore the prosthetic valve) relative to the delivery sheath 316.
The second knob 312 can be a rotatable knob configured to produce radial expansion and/or contraction of the prosthetic valve 10. For example, rotation of the second knob 312 can move the first and second actuation members 308, 309 axially relative to one another. Rotation of the second knob 312 in a first direction (e.g., clockwise) can radially expand the prosthetic valve 10 and rotation of the second knob 312 in a second direction (e.g., counter-clockwise) can radially collapse the prosthetic valve 10. In other embodiments, the second knob 312 can be actuated by sliding or moving the knob 312 axially, such as pulling and/or pushing the knob.
The third knob 314 can be a rotatable knob configured to release the prosthetic heart valve 10 from the delivery apparatus 300. For example, rotation of the third knob in a first direction (e.g., clockwise) can disengage the actuator assemblies 306 from the actuators 20 of the prosthetic valve 10. In other embodiments, the third knob 314 can be actuated by sliding or moving the third knob 314 axially, such as pulling and/or pushing the knob.
The outer struts 402a can comprise one or more locking features 404a disposed on a radially facing inner surface 406 of each respective outer strut 402a. The inner struts 402b can comprise one or more locking features 404b disposed on a radially facing outer surface 408 (see
Similar to struts 200 described above, each strut 402 can comprise a plurality of linear portions or segments 410 joined end-to-end relative to each other with adjacent ends interconnected by intermediate segments 412. The strut 402 can also have enlarged end portions 414 at either end of the strut 402 that form apices 416 at the inflow and outflow ends of the frame. Each of the intermediate segments 412 and end portions 414 can have a respective aperture 418 desirably at its geometric center for receiving a fastener, such as fastener 420 described below.
The inner and outer struts 402a, 402b can be pivotably coupled to one another at one or more pivot joints along the length of each strut. Respective hinges or junctions 422 can be formed at the locations where struts 402 overlap each other (including at apices 416) via fasteners 420 that extend through the apertures 418. The hinges 422 can allow the struts 402 to pivot relative to one another about a pivot axis (e.g., pivot axis 424) as the frame 401 is radially expanded or compressed, such as during assembly, preparation, or implantation of the prosthetic valve 10.
The one or more locking features 404 can be disposed, for example, at one or more of the end portions 414 of each strut 402 and/or at one or more of the intermediate segments 412. For example, in the illustrated embodiment, each strut 402a, 402b comprises a single locking feature 404a and 404b, respectively, disposed at a first end portion 414a, 414b of the strut. In other embodiments, a strut 402 can comprise a respective locking feature 404 at each intermediate segment 412 and/or at each end portion 414. In still other embodiments, a strut 402 can comprise locking features 404 at alternating intermediate segments 412 including or not including the end portions 414 and/or including only one of the end portions 414.
As shown in the illustrated embodiment, each locking feature 404 can be disposed at least partially circumferentially around a portion of a respective aperture 418 such that the locking feature 404 has an arcuate shape. In other embodiments, the locking feature can be disposed around the entire circumference of an aperture, such that the locking feature has a circular shape. In the illustrated embodiment, the locking features 404 have a width W extending from the aperture 418 to the outer edge of the end portion 414 in a radial direction of the pivot joint. However, in other embodiments, the width of the locking features 404 can extend only partially from the aperture 418 to the outer edge of the end portion 414.
As the first and second struts 402a, 402b pivot about the pivot axis 424, the first and second locking features 404a, 404b rotate about the fastener 420. As mentioned previously, when the frame 401 is in the radially compressed configuration, the first and second locking features 404a, 404b can be in the disengaged position, and when the frame 401 is in the expanded or partially expanded configuration, the first and second locking features 404a, 404b can be in the engaged position. When in the disengaged position, the first and second locking features 404a, 404b are rotationally offset from one another, and when in the engaged position the first and second locking features are rotationally aligned with one another.
As used herein, the term “rotationally offset” means that the first locking feature 404a is in a rotational position relative to the second locking feature 404b such that the first and second locking features 404a, 404b do not overlap one another (see
The locking features 404 can be formed integrally with each strut 402. That is, the strut 402 and the locking features 404 can be machined or otherwise formed from a single piece of material. For example, the locking feature 404 can be cut into a surface of the strut 402. Alternatively, the locking feature 404 can be formed separately and joined later in the fabrication process, such as by fasteners (e.g., screws), welding, or adhesives. In such embodiments, the strut 402 can comprise a recessed portion in which the locking feature can be disposed.
As shown in
As shown in
As shown in
Once the frame 401 is expanded to a diameter in which the first teeth 434a, 434b are engaged, as shown in
As shown in
In some embodiments, the first and/or second locking features 404a, 404b can comprise one or more rotational stops configured to prevent expansion of the frame beyond a preselected diameter. The rotational stops can be, for example, rectangular blocks or teeth disposed at either or both ends of the locking feature 404.
As mentioned previously, the first struts 402a and second struts 402b can be coupled at one or more junctions 422 using one or more fasteners 420. As best shown in
The biasing member 440 is configured to bias the locking features 404 of the first and second struts 402a, 402b against each other. In the illustrated embodiment, the biasing member 440 is disposed between the head portion 436 and a radially facing outer surface of the first strut 402a. In other embodiments, the biasing member 440 can be disposed between the head portion 436 and a radially facing inner surface of the second strut 402b (e.g., in embodiments wherein the head portion 436 is oriented radially inwardly). In still other embodiments, the biasing member 440 can be disposed between the end cap and the radially facing inner surface of the first or second struts 402a, 402b.
As the frame 401 is expanded and the first and second locking features 404a, 404b move into the engaged position, the biasing member 440 can bias the first and second locking features 404a, 404b against one another to prevent or mitigate slippage between the locking features. As the angled surfaces 432 slide against one another the first and second struts 402a, 402b can move radially away from one another and the biasing member 440 can be compressed against the head portion 436. The compression of the biasing member 440 allows the first and second struts 402a, 402b to move radially away from one another while keeping the first and second locking features 404a, 404b engaged with one another.
As best shown in
The prosthetic valve 400 including frame 401 can be expanded in the following exemplary manner. Generally, a distal end portion of the delivery apparatus 300 (along with prosthetic valve 400) can be advanced through the vasculature of a patient to a selected implantation site (e.g., the native aortic annulus) as previously described. The prosthetic valve 400 can then be deployed at the implantation site as previously described and locked in the expanded configuration using the first and second locking features 404a, 404b.
In a particular example, the actuators (e.g., actuators 20) of prosthetic valve 400 can include push-pull mechanisms 32 comprising inner and outer members 34, 36, as described above with reference to
For example, a distal end portion of a first actuation member 308 can engage or abut a corresponding outer member 36, and a distal end portion of the second actuation member 309 (
The prosthetic valve 500 can include a valvular structure (e.g., valvular structure 18) and inner and/or outer skirts, as previously described, although these components are omitted for purposes of illustration. The one or more expansion and locking mechanisms 550 can be used in lieu of or in addition to actuators 20 and/or locking features 404 described above. The expansion and locking mechanisms 550 can be used to both radially expand and lock the frame 502 of prosthetic valve 500 in a radially expanded state.
Each expansion and locking mechanism 550 can include an outer member in the form of a sleeve 552 having an inner lumen, cavity, or bore 554 (
The sleeve 552 in the illustrated embodiment has a rectangular shape in cross-section and the inner member 556 has a rectangular shape in cross-section corresponding to the shape of the bore 554. In other embodiments, the sleeve 552 and/or the inner member 556 can have a square cross-sectional profile. As shown in
As best shown in
The sleeve 552 can be coupled to the frame 502 at a second location, axially spaced from the first location. For example, in the illustrated embodiment, the inner member 556 is secured to the frame 502 near the distal or inflow end 506 of the frame and the sleeve 552 is secured to the frame 502 closer to or at the proximal or outflow end 508 of the frame, such as via a fastener 561 (e.g., a rivet or pint). The fastener 561 is affixed to and extends radially from the sleeve 552 through corresponding apertures at a junction of two overlapping struts 504 and can serve as a pivot pin around which the two struts 504 can pivot relative to each other and the sleeve 552. A nut 562 can be mounted on each fastener 561 to retain the fastener within the corresponding apertures. As discussed above in connection with the actuators 20 of the prosthetic valve 10 of
As shown in
Referring now to
The pawl 568 and the teeth 566 are configured such that when the pawl 568 is engaged with the rack 564, the inner member 556 and the sleeve 552 can move relative to one another in a first axial direction, but are prevented from moving relative to one another in a second, opposite axial direction. For example, in the illustrated embodiment, when the pawl 568 is engaged with the rack 564, the inner member 556 can move axially in a proximal direction (e.g., up in the orientation shown in
Once the prosthetic valve has been implanted within a selected implantation site within a patient, the patient's native anatomy (e.g., the native aortic annulus) may exert radial forces against the prosthetic valve that would tend to compress the frame 502. However, the engagement between the pawl 568 and the rack 564 prevents such forces from compressing the frame 502, thereby ensuring that the frame remains locked in the desired radially expanded state.
The inner member 556 can comprise an elongated member extending at least partially through the sleeve 552. In the illustrated embodiment, the sleeve 552 can comprise an opening 570 (
The pawl 568 can comprise an elongated body 574 terminating in a locking tooth 576 that can engage the teeth 566 of the linear rack 564. As shown in
Referring again to
The inner member 556 can comprise a toothless portion 578 extending from a proximal edge 580 of the inner member 556 to the plurality of teeth 566. The toothless portion 578 can be a flat portion of the inner member 556, as shown. The toothless portion 578 is configured to allow bi-directional axial movement (in the distal and proximal directions) of the inner member 556 relative to the sleeve 552. This allows the frame 502 to expand and/or contract prior to the engagement of the pawl 568 with the plurality of teeth 566. The length L1 of the toothless portion 578 can be selected to provide a reversibility range in which the prosthetic valve can be freely expanded and compressed without locking.
As best shown in
A prosthetic valve 500 including one or more expansion and locking mechanisms 550 can be expanded in the following exemplary manner. Generally, the prosthetic valve 500 is placed in a radially compressed state and releasably coupled to a distal end portion of a delivery apparatus, such as delivery apparatus 300 (
Each expansion and locking mechanism 550 can be releasably coupled to a respective actuation assembly 520 of a delivery apparatus, similar to actuation assemblies 306 of delivery apparatus 300. Referring now to
The distal end portion 526 of the second actuation member 524 can comprise an engagement member 528 (
In other embodiments, the engagement member 528 can have other configurations that permit the actuation member 524 to be releasably coupled to the inner member 556. For example, the engagement member 528 can be a magnet, and the inner member 556 can include a bore having a correspondingly magnetic material into which the engagement member can extend. The delivery apparatus can be used to apply a distally directed force to the sleeve 552 via the first actuation member 522 and/or a proximally directed force (as shown by arrow 515) to the inner member 556 via the second actuation member 524 to move the sleeve 552 and the inner member 556 axially relative to one another in a telescoping manner to cause the frame to radially expand. The distal end of the first actuation member 522 (also referred to as a support tube) can abut the sleeve 552.
Referring now to
As shown in
Referring to
In the illustrated embodiment, the retaining member 530 can be an elongated member sized to be inserted within the sleeve 552 and between the pawl 568 and the teeth 566 of the inner member 556. When the retaining member 530 is inserted within the sleeve 552, the retaining member 530 prevents the pawl 568 from moving toward the inner member 556 and thereby prevents the engagement of the tooth 276 of the pawl 568 with the plurality of teeth 566. Accordingly, the inner member 556 can move relative to the sleeve 552 in the proximal and/or distal directions, allowing for unrestricted radial expansion and radial compression of the prosthetic valve 500. The retaining member 530 can be removed from the expansion and locking mechanism 550 by, for example, moving the retaining member in a proximal direction until the retaining member 530 is no longer disposed between the pawl 568 and the inner member 556. Once the retaining member 530 is removed, the pawl 568 can engage the plurality of teeth 566 of the inner member 556 and lock the prosthetic valve 500 at a selected diameter.
In particular embodiments, the retaining member 530 is used to unlock the prosthetic valve 500 from an expanded configuration during assembly of the prosthetic valve and/or during a loading procedure. Typically, the components of the prosthetic valve 500 (the frame 502, the leaflets and other soft components) are assembled while the frame is in a locked, expanded configuration in which the tooth 576 of the pawl engages a tooth 566 of the rack 564. Following assembly, the retaining member 530 can be inserted into the expansion and locking mechanism 550 to push the tooth 576 of the pawl 568 out of engagement with the tooth 566 and prevent engagement of the tooth 576 with any of the other teeth 566 of the rack 564. This allows the inner member 556 to freely slide relative to sleeve 552, permitting radial compression of the prosthetic valve for subsequent loading of the prosthetic valve into or on the delivery apparatus.
In some embodiments, the prosthetic valve 500 can be provided to the end user (e.g., in a sterile package) in a locked, expanded configuration, and the end user can use the retaining member 530 to unlock the expansion and locking mechanism 550, radially compress the prosthetic valve, and load the prosthetic valve in or on the delivery apparatus (e.g., place the radially compressed prosthetic valve within a sheath of the delivery apparatus).
In some embodiments, the retaining member 530 can be a component of the delivery apparatus and can disposed between the inner member 556 and the pawl 568 during the implantation procedure. For example, each actuation assembly 520 of the delivery apparatus can include a respective retaining member 530 that extends from a corresponding expansion and locking mechanism 550 to a handle of the delivery apparatus. After delivering the prosthetic valve to a location at or adjacent the implantation site, the user can freely adjust the diameter of the prosthetic valve, including radially expanding and compressing the prosthetic valve. Once a selected expanded diameter for the prosthetic valve is achieved, the user can remove each retaining member 530 from its corresponding expansion and locking mechanism 550 in order to lock the prosthetic valve at the selected expanded diameter.
In some implementations, the retaining member 530 can be used to selectively disengage the pawl 568 from the plurality of teeth 566 after the locking mechanism 550 has been engaged to lock the prosthetic valve 500 in an expanded diameter during an implantation procedure. For example, the retaining member 530 can be advanced distally into the sleeve 552 to disengage the pawl 568 from the plurality of teeth 566 to permit radial compression of the frame if repositioning or recapture and removal of the prosthetic valve is desired.
The frame 602 can be coupled to one or more expansion mechanisms (such as one or more actuator assemblies 150 shown in
The frame 602 can include a plurality of interconnected struts 608 arranged in a lattice-type pattern and forming a plurality of distal apices 610 at the inflow end 612 of the frame 602 and a plurality of proximal apices 614 at the outflow end 616 of the frame. Each strut 608 can be coupled to one or more other struts 608 at a plurality of junctions 618 forming a plurality of cells 620. Each distal and proximal apex 610, 614 is also a junction 618.
Referring to
In the illustrated embodiment, each strut of a particular set is pivotably coupled to another strut of the same set at a distal apex 610, another strut of the same set at a proximal apex 614, and another strut of the same set at a junction 618 between the distal and proximal apices 610, 614 (desirably at a middle junction 618m at the midsections of the two overlapping struts equidistant from the distal and proximal apices). Thus, for example, each first strut 608a of the first set of struts is pivotably coupled to another first strut 608a of the first set at a distal apex 610, another first strut 608a of the first set at a proximal apex 614, and another first strut 608a of the first set at a middle junction 618m at the midsections of the two overlapping first struts wherein the middle junction 618m is equidistant from the distal and proximal apices.
Except where each strut 608a, 608b, 608c is pivotably coupled to a strut of the same set at a distal apex 610, a proximal apex 614, and a middle junction 618m, the strut can be pivotably coupled to a strut of a different set at junctions between the distal apex 610 and the middle junction 618m and at junctions between the proximal apex 614 and the middle junction 618m. For example, a first strut 608a can be pivotably coupled to a second strut 608b at a junction 618a, which is the junction along those struts closest to the proximal apices 614 at the outflow end 616. A first strut 608a can be pivotably coupled to a second strut 608b at a junction 618b, which is the junction along those struts closest to the distal apices 610 at the inflow end 612.
In alternative embodiments, struts of one set can be pivotably coupled to struts of another set at the distal apices 610, the proximal apices 614, and/or the middle junctions 618m.
The frame 602 can be coupled to one or more expansion mechanisms, such as one or more actuator assemblies 150 described above in connection with
Referring to
Each locking mechanism 604 can be coupled to a proximal junction and a distal junction of the same cell 620. For example, the sleeve 622 can be coupled to a proximal junction 618c (
In other embodiments, referring to
Moreover, a locking mechanism 604 can be connected to a pair of junctions along the same axial path on the frame as an actuator assembly 150, depending on the size and/or configuration of the actuator assembly, or to a pair of junctions that are circumferentially spaced from an actuator assembly. For example, a locking mechanism 604 can be connected to a pair of junctions 618g, 618h that are located along the same axial path as a pair of a stopper 160 and a sleeve 162, or a pair of junctions 618g, 618h that are circumferentially spaced from the closest pair of a stopper 160 and a sleeve 162.
Where more than one locking mechanism 604 is used, each locking mechanism 604 can be connected to the frame at similar junctions formed by struts of the same two sets. For example, each locking mechanism 604 can be connected to the frame at a respective pair of junctions 618c, 618d, or at a respective pair of junctions 618e, 618f, or at a respective pair of junctions 618g, 618h. In alternative embodiments, the locking mechanisms 604 can be connected to different pairs of junctions. For example, one locking mechanism 604 can be connected to the frame at a respective pair of junctions 618c, 618d, another locking mechanism 604 can be connected to the frame at a respective pair of junctions 618e, 618f, and another locking mechanism 604 can be connected to the frame at a respective pair of junctions 618g, 618h. In still other embodiments, some locking mechanisms 604 can be connected to similar junctions while other locking mechanism 604 can be connected to different junctions.
Unlike the embodiment of the expansion and locking mechanism of
As mentioned above, the frame 602 can further comprise one or more commissure attachment posts 606 (also referred to as a commissure attachment member). Desirably, the frame includes one commissure attachment post 606 for each commissure of the leaflet assembly (e.g., leaflet assembly 18 of
In other embodiments, a commissure clamp, such as commissure clamp 26 described above, can be mounted on the commissure attachment post 606. The commissure clamp 26 can be configured to grip adjacent portions of two leaflets at each commissure at a location spaced radially inwardly of the frame 602.
Each commissure attachment post 606 can be coupled to the frame 602 at any convenient location, which can be dictated by a desired position of a commissure within the frame. For example, in the illustrated embodiment, each commissure attachment post 606 is connected to a junction 618a, which is the junction closest to the proximal apices 614 of the frame 602. In other embodiments, each commissure attachment post 606 can be coupled to a junction 618 at a proximal apex 614. The commissure attachment posts 606 can be connected at various other junctions or other locations on the struts (e.g., at locations along the struts between junctions), depending on the design and/or size of the leaflets. As such, it should be understood that the locations of the commissure attachment posts need not be dictated by the positions of the actuator assemblies and/or locking mechanism on the frame. Further, each commissure attachment post can be a relatively short structure compared to the locking mechanisms and actuator assemblies.
Forming each device (the expansion mechanism 150, the locking mechanism 604, and commissure attachment post 606) as a separate device allows each device to be spaced apart from each other about the frame. Accordingly, each device can be positioned at a location selected to allow for optimal performance of the device.
In other embodiments, one or more of the devices can be combined into a single device that performs multiple functions. For example, in some embodiments, the expansion mechanism and locking mechanism can be combined into single device (e.g., expansion and locking mechanism 550) and the commissure attachment post can be a discrete structural element.
In one specific implementation, a combination expansion and locking mechanism (e.g., mechanism 550) (which can be used as a commissure post or separate commissure posts can be provided) can connected to a junction 618a and a junction 618b, or alternatively, to a junction 618a, a junction 618b, and a junction 618i (located axially between junctions 618a and 618b).
The prosthetic valve 700 can include a valvular structure (e.g., valvular structure 18) and inner and/or outer skirts, as previously described, although these components are omitted for purposes of illustration. The one or more expansion and locking mechanisms 710 can be used in lieu of or in addition to actuators 20, locking features 404, and/or expansion and locking mechanisms 550 described above. The expansion and locking mechanisms 710 can be used to both radially expand the frame 702 and lock the frame in a radially expanded state.
Referring to
As best shown in
The outer member 712 can be coupled to the frame 702 at a second location, axially spaced from the first location. For example, in the illustrated embodiment, the inner member 716 is secured to the frame 702 near the distal or inflow end 706 of the frame and the outer member 712 is secured to the frame 702 closer to or at the proximal or outflow end 708 of the frame, such as via a fastener 732 (e.g., a rivet or pint). The fastener 732 is affixed to and extends radially from the outer member 712 through corresponding apertures at a junction of two overlapping struts 704 and can serve as a pivot pin around which the two struts 704 can pivot relative to each other and the outer member 712. A nut (such as nut 562 described previously) can be mounted on each fastener 732 to retain the fastener within the corresponding apertures. As discussed above in connection with the actuators 20 of the prosthetic valve 10 of
Referring now to
As shown in
The outer member 712 in the illustrated embodiment has an outer profile that is rectangular shape in cross-section. The inner bore 714 can comprise a first, distal portion 744 (
In some embodiments, the proximal end portion 754 of the inner member 716 can have a circular shape in cross-section (see e.g.,
Referring again to
As best shown in
Referring again to
The inner member 716 can comprise an elongated member extending at least partially into the outer member 712. In some embodiments, the inner member 716 can be housed entirely within the outer member 712 and the outer member 712 can be closed at its distal end. As shown in
Referring now to
The second end portion 768 of the locking member 718 can comprise a locking tooth 774 that can engage the teeth 762 of rack 760 and a disengagement tooth 776. The disengagement tooth 776 can extend axially from the second end portion 768 and can be configured to engage a disengagement member, such as disengagement member 802, as described in more detail below with reference to
Referring to
Referring now to
While
As shown in the illustrated embodiment, the protrusion can have a substantially cylindrical shape. As shown in
This configuration can advantageously simplify manufacturing, for example, by allowing much simpler processing and machining procedures (such as Swiss-type and milling procedures) to be used. Additionally, this configuration avoids small fasteners, which can in some instances be difficult to manufacture and assemble, and additionally avoids welding, which can be inaccurate and impractical at such small sizes. Moreover, the oval (or circular) shapes of the inner member 716 and the openings formed in the outer member 712 are easier to manufacture than components having square or rectangular cross-sectional shapes.
In other embodiments, although less desirable, the locking member 718 can be coupled to the outer member 712 using one or more fasteners extending through the apertures 758, 770. The fasteners can be, for example, rivets or pins.
In alternative embodiments, the locking member 718 can be formed integrally with the outer member 712 such as by cutting the shape of the locking member 718 into a sidewall 724, 726 of the outer member.
Referring to
Furthermore, as shown in the illustrated embodiment of
Additionally, this configuration can advantageously provide sufficient engagement between the locking tooth 774 and the teeth 762 of the linear rack in the locked stated, without the need to form oblique engaging edges, thereby significantly simplifying the manufacturing process.
The pawl 718 and the teeth 762 are configured such that when the pawl 718 is engaged with the rack 760, the inner member 716 and the outer member 712 can move relative to one another in a first axial direction, but are prevented from moving relative to one another in a second, opposite axial direction. For example, in the illustrated embodiment, when the pawl 718 is engaged with the rack 760, the inner member 716 can move axially in a proximal direction (see arrow 734 in
Once the prosthetic valve has been implanted within a selected implantation site within a patient, the patient's native anatomy (e.g., the native aortic annulus) may exert radial forces against the prosthetic valve that would tend to compress the frame 702. However, the engagement between the pawl 718 and the rack 760 prevents such forces from compressing the frame 702, thereby ensuring that the frame remains locked in the desired radially expanded state.
Referring to
As shown in
The second neck portion 786 can be configured to further bias the locking tooth 774 against the linear rack 760. Referring to
Referring to
During delivery of the prosthetic valve 700, the inner member 716 can be coupled to an actuation member of the delivery apparatus (such as actuation member 524 described above). When so coupled to the actuation member, the toothless portion 788 of the inner member 716 and a distal end portion of the actuation member define a reversibility range.
A prosthetic valve 700 including one or more expansion and locking mechanisms 710 can be expanded in the following exemplary manner. Generally, the prosthetic valve 700 is placed in a radially compressed state and releasably coupled to a distal end portion of a delivery apparatus, such as delivery apparatus 300 (
Each expansion and locking mechanism 710 can be releasably coupled to a respective actuation assembly of a delivery apparatus, such as actuation assemblies 306 of delivery apparatus 300. Each actuation assembly 306 can comprise a first or outer actuation member 308 (see
Referring to
In other embodiments, the engagement portion can have other configurations that permit releasably coupling the second actuation member to the inner member 716. For example, the engagement portion of the second actuation member 309 can comprise a magnet and the inner bore 792 of the inner member 716 can comprise a correspondingly magnetic material into which the engagement portion of the second actuation member can extend. The delivery apparatus can be used to apply a distally directed force to the outer member 712 via the outer actuation member 308 and/or a proximally directed force to the inner member 716 via the inner actuation member 309 to move the outer member 712 and the inner member 716 axially relative to one another in a telescoping manner to cause the frame 702 to radially expand.
When the frame 702 is in the radially compressed configuration, the inner member 716 can move relative to the outer member 712 in the proximal and/or distal directions. As the inner member 716 moves, the locking tooth 774 of the pawl 718 can slide along a distal end portion of the outer actuation member 308 and/or the toothless portion 788 of the inner member 716 until it engages the plurality of teeth 762, as shown in
The frame 702 can continue to be expanded by, for example, moving the inner member 716 proximally (as shown by arrow 734) until a selected prosthetic valve diameter is achieved. The selected diameter can correspond to a selected position of the locking tooth 774 of the pawl 718 in which it engages any tooth of the plurality of teeth 762.
As shown in
Referring now to
The disengagement member 802 can comprise a first end portion 804 and a second end portion 806. The second end portion 806 can be an elongated member sized to be inserted through the first opening 748 in the bore 714 of the outer member 712. A distal end portion of the second end portion can comprise a disengagement portion 808 including an angled surface 810.
As shown in
In some embodiments, the disengagement member 802 can be used to selectively disengage the pawl 718 from the plurality of teeth 762 after the locking tooth 774 has engaged the linear rack 760 to lock the prosthetic valve 700 in an expanded diameter during an implantation procedure. For example, the disengagement member 802 can be advanced distally into the outer member 712 to disengage the pawl 718 from the plurality of teeth 762 to permit radial compression of the frame 702 if repositioning or recapture and removal of the prosthetic valve is desired.
In some embodiments, the disengagement member 802 can be used to perform any of the various functions described with respect to the retaining member 530, described above. That is, in particular embodiments, the disengagement member 802 is used to unlock the prosthetic valve 700 from an expanded configuration during assembly of the prosthetic valve and/or during a loading procedure, permitting radial compression of the prosthetic valve for subsequent loading of the prosthetic valve into or on the delivery apparatus.
In other embodiments, the disengagement member 802 can be a component of the delivery apparatus and can be disposed between the inner member 716 and the pawl 718 during the implantation procedure. In some embodiments, the delivery apparatus can include an actuation assembly 306 or 520 for each expansion and locking mechanism 710, and each actuation assembly 306, 520 can include a disengagement member 802 that can extend through a corresponding outer actuation member 308 or 522 of an actuation assembly 306, 520, respectively. Each disengagement member 802 can extend from the prosthetic valve 700 to the handle of the delivery apparatus (e.g., handle 302). The proximal end portion of each disengagement member 802 can be operatively connected to a knob on the handle, which is operable to move the disengagement members proximally and distally relative to the expansion and locking mechanisms 710.
After delivering the prosthetic valve to a location at or adjacent the implantation site, the user can freely adjust the diameter of the prosthetic valve, including radially expanding and compressing the prosthetic valve. Once a selected expanded diameter for the prosthetic valve is achieved, the user can remove the disengagement member 802 from its corresponding expansion and locking mechanism 710 in order to lock the prosthetic valve at the selected expanded diameter.
As shown in
Referring to
In some embodiments, the distal end portion 728 of the inner member 716 can comprise a threaded portion extending all or partially along the length of the distal end portion 728. The inner annular surface 816 of the stopper 814 can have a correspondingly threaded surface configured such that the stopper 814 can be axially displaced along the length of the inner member 716. For example, rotation of the stopper 814 in a first direction (e.g., clockwise) can move the stopper 814 distally relative to the inner member 716, and rotation of the stopper 814 in a second direction (e.g., counterclockwise) can move the stopper 814 proximally relative to the inner member 716. The axial position of the stopper 814 along the inner member 716 can determine the maximum diameter to which the prosthetic valve 700 can expand.
Prior to the implantation procedure, the physician can adjust the location of the stopper 814 along the inner member 716 to set a selected maximum diameter for the prosthetic valve 700 sized to accommodate a specific patient's anatomical variability (e.g., selecting the size which best fits the patient's native annulus).
In some embodiments, the inner member 716 can comprise a series of markings or measurement indicia that visually indicate to a physician the position of the stopper 814 that corresponds to a particular maximum prosthetic valve diameter. The physician can set a selected maximum diameter by adjusting the position of the stopper 814 such that it aligns with the indicator corresponding to the desired prosthetic valve diameter.
As the prosthetic valve is expanded (e.g., using actuators 20), the inner member 716 can slide proximally relative to the outer member 712 until the stopper 814 abuts the distal edge 740 of the outer member 712, thereby restraining further motion of the inner member 716 and retaining the prosthetic valve 700 at a predetermined diameter.
Referring now to
As shown in
In the illustrated embodiment, the aperture 912 is circular, however, in other embodiments, the aperture 912 can have any of various shapes. For example, the aperture can be an oval, a square, a rectangle, a square-oval, a triangle, a hexagon, an octagon, a pentagon, etc. In some embodiments, the aperture can have a shape that is symmetrical along two axes. In other embodiments, the aperture 912 can have a shape that is symmetrical along one axis, or a shape that is asymmetrical.
In the illustrated embodiment, the aperture 912 is positioned distal to the fastener 918 that extends from the outer member 906. As shown in
As best seen in
Referring again to
Once the prosthetic valve 900 is fully assembled, it can be coupled to the delivery apparatus 300 as described previously with respect to prosthetic valve 700. The second actuator 309 can extend into the bore 938 of the outer member 906 and releasably couple the second member 908. Because this coupling takes place within the bore 938 of the outer member 906, it can be difficult to determine whether the second actuator 309 is suitably coupled to the second member 908 rather than simply disposed within the bore. The aperture 912 advantageously allows a user to verify that the second actuator 309 has been coupled to the second member 908. The prosthetic valve 900 can then be radially compressed for delivery to the selected implantation site.
Positioning the aperture 912 as shown in the illustrated embodiment advantageously allows the user to determine whether the prosthetic valve 900 is coupled to the delivery apparatus 300 without compromising the structural integrity and/or strength of the commissure, and without compromising the structural integrity and/or strength of the prosthetic valve. Furthermore, an operator can determine, prior to radial compression and/or implantation of the prosthetic valve, whether the delivery apparatus and the prosthetic valve are suitably coupled.
The prosthetic valve 1000 can include inner and/or outer skirts, as previously described, although these components are omitted for purposes of illustration. The one or more expansion and locking mechanisms 1006 can be used in lieu of or in addition to actuators 20, locking features 404, and/or expansion and locking mechanisms 550, 710 described above. The expansion and locking mechanisms 1006 can be used to both radially expand the frame 1002 and lock the frame in a radially expanded state.
Referring now to
Similar to expansion and locking mechanism 710, the outer member 1014 can comprise a first fastener 1015 coupled to the frame 1002 at a first location and the inner member 1016 can comprise a second fastener 1017 coupled to the frame 1002 at a second location spaced apart from the first location. The inner member 1016 can be axially movable relative to the outer member 1014 in a proximal direction (e.g., toward the outflow end 1012 of the frame) and in a distal direction (e.g., toward the inflow end 1010 of the frame). As such, because the inner member 1014 and the outer member 1016 are secured to the frame 1002 at axially spaced locations, moving the inner member 1016 and the outer member 1014 axially with respect to one another in a telescoping manner can cause radial expansion or compression of the frame 1002.
As shown in
In the illustrated embodiment, the first aperture 1024 has a rectangular shape with rounded corners. The first aperture 1024 can have a width W1 and a length L1. As best seen in
Referring to
Referring to
Referring again to
The outer member 1014 can have an asymmetrical shape in cross-section. Referring to
Referring now to
In some embodiments, as shown, the wedge 1062 is an elongated member having a circular shape in cross-section. However, in other embodiments, the wedge can have any of various shapes in cross-section, such as, for example, triangular, ovular, square, rectangular, C-shaped, semi-circular, etc.
The tabs 1046 and wedge 1062 can then be coupled to the expansion and locking mechanism 1006 using, for example, one or more sutures. For example, the sutures can wrap around the expansion and locking mechanism 1006 such that they hold the wedge 1062 in position. Further details regarding various attachments techniques and mechanisms for attaching commissures to expansion and locking mechanisms are disclosed in U.S. Publication No. 2018/0325665; U.S. Publication No. 2019/0105153; U.S. Application No. 62/869,948; U.S. Application No. 62/813,643; and PCT Application No. PCT/US2019/61392, all of which documents are incorporated herein by reference. Any of the techniques and mechanisms disclosed in the prior documents can be used to connect the commissures formed by tabs 1046 to the expansion and locking mechanisms 1006.
Referring again to
Referring now to
In the illustrated embodiment, each commissure opening 1112 is substantially U-shaped. However, in other embodiments, the commissure opening 1112 can have any of various shapes configured to accept the leaflets 1120. For example, the commissure openings 1112 can be ovular, square, rectangular, triangular, L-shaped, T-shaped, etc. The first aperture 1114 can have a length L3 and the second aperture 1116 can have a length L4 greater than L3. As shown in
Similarly to commissure openings 1022, commissure openings 1112 can have an angled surface 1122 extending between the inflow edges 1124, 1126 (
Referring to
As shown in
As best seen in
Referring now to
As best seen in
The leaflets 1120 and wedge 1146 can then be coupled to the expansion and locking mechanism 1104 using, for example, one or more sutures. For example, the sutures can wrap around the expansion and locking mechanism 1104. Further details regarding various attachments techniques and mechanisms for attaching commissures to expansion and locking mechanisms are disclosed in U.S. Publication No. 2018/0325665; U.S. Publication No. 2019/0105153; U.S. Application No. 62/869,948; U.S. Application No. 62/813,643; and PCT Application No. PCT/US2019/61392, all of which documents are incorporated herein by reference. Any of the techniques and mechanisms disclosed in the prior documents can be used to connect the leaflets 1120 to the expansion and locking mechanisms 1104.
Referring again to
Referring now to
The first side wall 1226 of the outer member 1210 can be substantially straight, and the second side wall 1228 can comprise an angled portion 1230 that extends away from a longitudinal axis of the expansion and locking mechanism 1208. Accordingly, as best shown in
A commissure assembly can be mounted to a respective expansion and locking mechanism 1208 in the same manner as described previously for expansion and locking member 1104 with reference to
In some or all of the previously described embodiments, the outer profile of the expansion and locking mechanisms (e.g., expansion and locking mechanisms 1006, 1104, 1208) can comprise chamfered or rounded edges.
In some embodiments, the spacing S2 can be greater than the spacing S3 which can be greater than the spacing S1. For example, the spacing S2 can be about 1.26 mm, the spacing S3 can be about 1.24 mm, and the spacing S1 can be about 0.75 mm. The greater (relative to S1) spacing provided in prosthetic valves 1400 and 1500 advantageously provides fewer restrictions on the size of the leaflets and/or the size of the expansion and locking mechanisms 1404, 1504.
The outer member 1602 can include a cavity or bore 1610. The bore 1610 can have a shape in cross-section similar to the outer profile of the number ‘8.’ That is, the bore 1610 can have a first portion 1612 and a second portion 1614 separated by a neck portion 1616. As best seen in
Referring to
As best seen in
As best seen in
When the expansion and locking mechanism 1600 is assembled, the locking member 1606 can be disposed in the first portion 1612 of the bore 1610 and the inner member 1604 in the second portion 1614 of the bore such that the flat surface 1644 of the locking member 1606 faces the flat surface 1632 of the inner member 1606. The curved surfaces 1634, 1642 of the inner member 1604 and the locking member 1606 can abut the inner edges of the first and second portions 1612, 1614 of the bore 1610, respectively. In some embodiments, the flat surfaces 1632, 1644 can be spaced apart from one another such that they do not contact one another. In other embodiments, the flat surfaces 1632, 1644 can contact one another. In embodiments wherein the surfaces 1632, 1644 contact one another, each surface can be polished to have low coefficients of friction, such that the surfaces can slide easily along one another, and/or each surface can be coated with one or more lubricious, low-friction layers.
Advantageously, the disclosed configuration ensures that at least a portion of the locking member 1606 is fully retained within the outer member 1602, thereby preventing or mitigating the risk of spontaneous detachment of the locking member 1606 from the expansion and locking mechanism 1600.
Referring to
The inner and outer walls 1708, 1710 of the outer member 1702 can each include a respective lateral extension 1706. The lateral extensions 1706 can be aligned with the second end portion 1726 of the opening 1722 and can be used to retain the locking member 1704 within the opening 1722. The extensions 1706 can comprise a bendable portion 1732 configured to allow them to be bent such that they extend over the opening 1722, as shown in
Referring to
Referring to
Referring now to
This configuration can advantageously simplify manufacturing, for example, by allowing much simpler processing and machining procedures (such as Swiss-type and milling procedures) to be used. Additionally, this configuration avoids small fasteners, which can in some instances be difficult to manufacture and assemble, and additionally avoids welding, which can be inaccurate and impractical at such small sizes. Moreover, the recess 1734 in the locking member 1704 and the lateral extensions 1706 are easier to manufacture than components having more complex shapes.
Referring to
The inner and outer walls 1808, 1810 of the outer member 1802 can each include a respective lateral extension 1806. The lateral extensions 1806 can be aligned with the second end portion 1820 of the opening 1814 and can be used to retain the locking member 1804 within the opening 1814. The extensions 1806 can comprise a bendable portion 1824 (
The second end portion 1822 can comprise a recess 1826 including two angled surfaces 1828. The angled surfaces 1828 can be angled toward a longitudinal axis of the locking member 1804 relative to a base surface 1829 of the locking member, such that the locking member 1804 has a substantially triangular shape in cross-section, with the apices of the triangle cut off. When expansion and locking mechanism 1800 is assembled, the lateral extensions 1806 of the outer member 1802 can abut or engage the angled surfaces 1828, thereby retaining the locking member 1804 within the opening 1814 of the outer member 1802. In some embodiments, each lateral extension 1806 can comprise a chamfered edge surface 1830. The chamfered edge surfaces 1830 can be configured such that when the lateral extensions 1806 are disposed against the angled surfaces 1828, the lateral extensions 1806 do not protrude out of the recess 1826 (e.g., do not extend past the side surface 1812 of the outer member 1802).
The locking member 1804 can be coupled to the outer member 1802 in the following exemplary manner. As shown in
An inwardly-directed force (e.g., toward a longitudinal axis of the expansion and locking mechanism 1800) can be applied to the lateral extensions 1806, thereby deforming the bendable portion 1824 such that the lateral extensions 1806 abut the angled surfaces 1828, as shown in
This configuration can advantageously simplify manufacturing, for example, by allowing much simpler processing and machining procedures (such as Swiss-type and milling procedures) to be used. This configuration further avoids small fasteners, which can in some instances be difficult to manufacture and assemble, and additionally avoids welding, which can be inaccurate and impractical at such small sizes. The recess 1826 in the locking member 1804 and the lateral extensions 1806 are easier to manufacture than components having more complex shapes. Moreover, the angled surfaces 1828 of the recess 1826 create a larger contact area between the lateral extensions 1806 and the locking member 1804, which can prevent or mitigate movement of the locking member 1804 relative to the outer member 1802.
Referring to
Referring to
The second end portion 1920 can comprise first and second recesses 1926 and 1928 (
The locking member 1904 can be coupled to the outer member 1902 in the following exemplary manner. As shown in
In the illustrated embodiment, the protrusions 1932, 1934 have a V-shape corresponding to the V-shape of the recesses 1926, 1928. However, in other embodiments, the protrusions can have any of various shapes corresponding to the shape of the recesses 1926, 1928. Though
This configuration can advantageously simplify manufacturing, for example, by allowing much simpler processing and machining procedures (such as Swiss-type and milling procedures) to be used. This configuration further avoids small fasteners, which can in some instances be difficult to manufacture and assemble, and additionally avoids welding, which can be inaccurate and impractical at such small sizes. The recesses 1926, 1928 in the locking member 1904 are easier to manufacture than components having more complex shapes. Moreover, the angled surfaces 1930 within each recess 1926, 1928 create a larger contact area between the protrusions 1932, 1934 and the locking member 1904, which can prevent or mitigate movement of the locking member 1904 relative to the outer member 1902.
Referring now to
Referring now to
In some embodiments, the fastener 2000 can be formed as a separate component coupled to a radially outer wall of the expansion and locking mechanism. For example, the body portion 2004 can extend through an aperture in the outer wall and the base portion 2002 can abut the radially inner surface of the outer wall. In some embodiments, the radially inner surface of the outer wall can comprise a recess in which the base portion 2002 of the fastener 2000 can be disposed. In other embodiments, the fastener 2000 can be formed integrally with the expansion and locking mechanism and can, for example, extend radially from an outer surface of the radially outer wall.
In the illustrated embodiment, the fastener 2000 is a solid piece of material. Such a configuration provides greater retention strength and improved performance. However, in other embodiments, the fastener can be configured as a hollow tube, see, for example, fasteners 730 and 732.
Referring now to
The fastener 2000 can be secured within the apertures 2010 in the following exemplary manner. Once the fastener 2000 has been disposed within the apertures 2010, a radially outer end surface 2016 of the body portion 2004 can be radially riveted to form a flanged portion 2018, as shown in
Referring to
Radial riveting has various advantages. Namely, radial riveting applies very little lateral force, mitigating the need to clamp or fix the fastener 2000 in place during the riveting process, and applies very little axial force, thereby mitigating the risk of damaging the components surrounding the fastener (such as struts 2012). Moreover, since radial riveting is a cold-forming process, the flanged portion 2018 can be formed without deforming or swelling the remainder of the fastener body 2004. The radial riveting process can further produce a smooth, finished surface on the flanged end portion 2018, mitigating potential damage if the fastener 2000 comes in contact with the sheath of the delivery apparatus during delivery of the prosthetic valve and/or comes in contact with the native anatomy of the implantation site. This configuration can advantageously simplify assembly of a prosthetic valve, for example, by allowing much simpler processing and machining procedures to be used. This configuration further avoids impact punching, such as is performed on hollow tube fasteners having internal bores. Drilling internal bores can be difficult when components are very tiny.
Though the preceding description refers to fasteners 2000 coupled to an expansion and locking mechanism, it should be noted that fasteners such as fastener 2000 can be used at any junction between two struts to pivotably couple the struts together, and that the above-described processes can be used to retain the fasteners 2000 within any such junctions.
Referring now to
Referring to
Referring now to
Referring to
The fastener 2124 can be coupled to the outer member 2100 in the following exemplary manner. The base portion 2138 of the fastener 2124 can be inserted into the entry portion 2134 of the opening 2122 such that the recessed portions 2142 are aligned with the edges of the guide portion 2132 (e.g., such that the fastener 2124 is rotationally aligned with the fastener opening 2122). The fastener 2124 can be advanced through the guide portion 2132 by sliding the recessed portions 2142 along the guide portion 2132 until the fastener 2124 is disposed in the main portion 2130. The fastener 2124 can then be rotated until the recessed portions 2142 are rotationally offset from the guide portion 2132. When the fastener 2124 is rotationally offset from the fastener opening 2122, the body portion 2140 of the fastener 2124 is too wide to fit through the guide portion 2132, thereby securing the fastener within the opening 2122. In some embodiments, the guide portion 2132 can be deformed (e.g., by pinching and/or welding) after insertion of the fastener 2124 into the main portion 2130, to further retain the fastener 2124 within the main portion 2130.
Referring now to
The indentations 2144 can be formed on the radially inner and/or radially outer walls 2106, 2108. In the illustrated embodiment, as shown in
The embodiments illustrated in
Referring now to
Referring to
Referring to
The locking member 2220 can be coupled to the outer member 2200 in the manner described previously (e.g., using indentations in one or more walls of the outer member 2200). The inner member 2226 can then be disposed at least partially within the bore 2205 of the outer member 2200 to form the expansion and locking mechanism, which can function similarly to expansion and locking mechanisms 710, 1006, 1104, 1208, etc. described above.
The configuration illustrated in
For purposes of this description, certain aspects, advantages, and novel features of the embodiments 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 embodiments, 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 embodiments require that any one or more specific advantages be present or problems be solved.
Although the operations of some of the disclosed embodiments 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.
All features described herein are independent of one another and, except where structurally impossible, can be used in combination with any other feature described herein. For example, a delivery apparatus 200 as shown in
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 term “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.
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 (e.g., 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 (e.g., 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.
In view of the many possible embodiments to which the principles of the disclosure may be applied, it should be recognized that the illustrated embodiments are only preferred examples and should not be taken as limiting the scope of the disclosure. Rather, the scope of the disclosure is defined by the following claims. We therefore claim all that comes within the scope and spirit of these claims.
This application is a continuation of International Application No. PCT/US2020/057691, filed Oct. 28, 2020, which claims the benefit of U.S. Provisional Application 63/026,267 filed on May 18, 2020, U.S. Provisional Application 63/013,912 filed on Apr. 22, 2020, U.S. Provisional Application 62/981,666 filed on Feb. 26, 2020, U.S. Provisional Application 62/950,005 filed on Dec. 18, 2019, and U.S. Provisional Application 62/928,291 filed on Oct. 30, 2019, all of which are incorporated by reference herein in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63026267 | May 2020 | US | |
| 63013912 | Apr 2020 | US | |
| 62981666 | Feb 2020 | US | |
| 62950005 | Dec 2019 | US | |
| 62928291 | Oct 2019 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2020/057691 | Oct 2020 | US |
| Child | 17732985 | US |
