Patent Application
20230165678
The present invention relates to implantable prosthetic devices, such as prosthetic heart valves with mechanisms for adjusting the tension of leaflets mounted therein, and to methods, adjustment assemblies and delivery assemblies for, and including, such devices.
Native heart valves, such as the aortic, pulmonary and mitral valves, function to assure adequate directional flow from, and to, the heart, and between the heart’s chambers, to supply blood to the whole cardiovascular system. Various valvular diseases can render the valves ineffective and require replacement with artificial valves. Surgical procedures can be performed to repair or replace a heart valve. Since surgeries are prone to an abundance of clinical complications, alternative less invasive techniques of delivering a prosthetic heart valve over a catheter and implanting it over the native malfunctioning valve have been developed over the years.
Different types of prosthetic heart valves are known to date, including balloon expandable valve, self-expandable valves and mechanically-expandable valves. Different methods of delivery and implantation are also known, and may vary according to the site of implantation and the type of prosthetic valve. One exemplary technique includes utilization of a delivery assembly for delivering a prosthetic valve in a crimped state, from an incision which can be located at the patient’s femoral or iliac artery, toward the native malfunctioning valve. Once the prosthetic valve is properly positioned at the desired site of implantation, it can be expanded against the surrounding anatomy, such as an annulus of a native valve, and the delivery assembly can be retrieved thereafter.
An implantation procedure of a prosthetic valve includes expansion thereof at the implantation site, to an expansion diameter that matches the patient’s anatomy. Different patient may have various anatomical structures, that will require the prosthetic valve to expand to the appropriate diameter matching the specific patient’s anatomy and/or pathology at the site of implantation. It may be desirable to provide prosthetic valves that can be expanded to a wide range of final expansion diameters, in order to lower production costs and simplify inventory management. However, one of the limiting factors for the diameters to which a prosthetic valve can be expanded relates to the leaflets mounted within the frame of the prosthetic valve, which need to properly coapt so as to prevent retrograde blood from flowing between leaflets during diastole. Overexpansion or under-expansion of the frame may result in overstretching or loosening of the leaflets, which in turn may result in impaired coaptation. Thus, a need exists for mechanisms that will allow prosthetic valve to be utilized in a wide range of expansion dimeters, while preserving adequate coaptation between the leaflets during diastole.
The present disclosure is directed toward prosthetic heart valves that include an adjustable commissure supports to which leaflet assemblies are attached, wherein the adjustable commissure supports include adjustable arms that can be either rotated or twisted, thereby enabling the tension of the leaflets attached thereto to be adjusted, so as to match the desired expansion diameter of the frame, and allow proper coaptation between the leaflets when the frame is expanded to the desired diameter.
According to one aspect of the invention, there is provided a prosthetic valve comprising a frame movable between a radially compressed configuration and a radially expanded configuration, a leaflet assembly mounted within the frame, and a plurality of adjustable commissure supports.
The leaflet assembly comprises a plurality of leaflets configured to regulate flow through the prosthetic valve. Each leaflet comprises a rounded cusp end portion defining a cusp edge, a free edge opposite to the cusp edge, and a pair of oppositely-directed tabs separating the cusp edge and the free edge.
Each adjustable commissure support comprises a support base attached to the frame, and at least one adjustable arm extending proximally from the support base. Each adjustable arm comprises an engagement portion.
The tabs are attached to the adjustable arms. The adjustable arms are configured to rotate or twist when rotational force is applied to the engagement portions. Rotation or twisting of the adjustable arms causes the tabs attached thereto, to wind around the adjustable arms.
According to some embodiments, the support base is integrally formed with the frame.
According to some embodiments, the tabs are wrapped over the adjustable arms.
According to some embodiments, each adjustable arm has a non-circular cross section.
According to some embodiments, each adjustable arm comprises a plurality of apertures.
According to some embodiments, the apertures are axially spaced apart from each other.
According to some embodiments, the tabs are sutured to the adjustable arms via sutures through the tabs and the apertures.
According to some embodiments, the sutures extend through portions of the tab disposed over opposite sides of the adjustment arms.
According to some embodiments, the engagement portion comprises a non-cylindrical socket.
According to some embodiments, the engagement portion comprises a proximally oriented extension formed as a drive-screw coupler.
According to some embodiments, the engagement portion comprises an angled surface.
According to some embodiments, the adjustable arms are rigidly attached to the support base.
According to some embodiments, the adjustable arms are integrally formed with the support base.
According to some embodiments, the adjustable arms are configured to twist between the support base and the engagement portions, upon application of rotational force to the engagement portions.
According to some embodiments, the adjustable arms comprise a plastically deformable material.
According to some embodiments, the adjustable arms are rotationally coupled to the support base.
According to some embodiments, the adjustable arms are threadedly coupled to the support base.
According to some embodiments, the support base comprises at least one base threaded portion, wherein each adjustable arm comprises an adjustable arm threaded portion, configured to threadedly engage with the base threaded portion.
According to some embodiments, the support base further comprises at least one offsetting extension, extending radially therefrom, wherein the at least one adjustable arm extends from the respective offsetting extension.
According to some embodiments, the at least one offsetting extension extends radially away from the support base.
According to some embodiments, the at least one offsetting extension extends radially inward with respect to the support base.
According to some embodiments, the offsetting extension is integrally formed with the support base.
According to some embodiments, each adjustable commissure support further comprises a commissure support fastening extension.
According to some embodiments, the adjustable commissure supports are attached to the frame via the commissure support fastening extensions, such that the adjustable arms are positioned radially inward with respect to the frame.
According to some embodiments, each adjustable commissure support comprises a single adjustable arm.
According to some embodiments, two tabs of adjacent leaflets of the leaflet assembly are attached to the adjustable commissure support, such that both tabs are wrapped over the single adjustable arm.
According to some embodiments, the leaflets are asymmetric leaflets, each asymmetric leaflet having a short tab and an opposite long tab, wherein the tabs of adjacent leaflets are wrapped over the single adjustable arm such that the short tab of one leaflet is wrapped around the adjustable arm, in direct contact therewith, and the long tab of the adjacent leaflet is wrapped over the short tab.
According to some embodiments, the length of the long tab is at least 10% as great as than the length of the short tab.
According to some embodiments, the length of the long tab is at least 20% as great as than the length of the short tab.
According to some embodiments, the length of the long tab is at least 50% longer than the length of the short tab.
According to some embodiments, the length of the long tab is at least 100% longer than the length of the short tab.
According to some embodiments, each adjustable commissure support comprises two adjustable arms that are laterally spaced from each other and define a gap therebetween.
According to some embodiments, two tabs of adjacent leaflets of the leaflet assembly are attached to the adjustable commissure support, such that each tab is wrapped over one of the adjustable arms.
According to some embodiments, both tabs are wrapped over the respective adjustable arms in opposite directions with respect to each other.
According to some embodiments, the gap is at least two times larger than the thickness of the tabs.
According to some embodiments, the gap is at least four times larger than the thickness of the tabs.
According to some embodiments, the gap is at least six times larger than the thickness of the tabs.
According to some embodiments, the gap is at least eight times larger than the thickness of the tabs.
According to another aspect of the invention, there is provided a prosthetic valve comprising a frame movable between a radially compressed configuration and a radially expanded configuration, a leaflet assembly mounted within the frame, and a plurality of adjustable commissure supports.
The leaflet assembly comprises a plurality of leaflets configured to regulate flow through the prosthetic valve. Each leaflet comprises a rounded cusp end portion defining a cusp edge, a free edge opposite to the cusp edge, and a pair of oppositely-directed tabs separating the cusp edge and the free edge.
Each adjustable commissure support comprises a support base attached to the frame, two adjustable arms coupled to the support base, and rotatable relative thereto, and two scallop adjustment arms. Each adjustable arm comprises an engagement portion. Each scallop adjustment arm extends continuously from one of the adjustable arms.
The tabs of adjacent leaflets are attached to the adjustable commissure supports, such that each tab is attached to one of the adjustable arms. Portions of the cusp edge of each leaflet are attached to scallop adjustment arms of adjustable commissure supports on both sides of the leaflet.
Both adjustable arms and scallop adjustment arms of a single adjustable commissure supports are configured to rotate in opposite directions, when opposite rotational forces are applied to their engagement portions. Rotation of the adjustable arms and the scallop adjustment arms causes the tabs to wind around the adjustable arms they are attached to, and causes the portions of the cusp edges to wind around the scallop adjustment arms they are attached to.
According to some embodiments, the support base is integrally formed with the frame.
According to some embodiments, each adjustable arm and the scallop adjustment arm extending therefrom are integrally formed.
According to some embodiments, the scallop adjustment arm comprises a torque transmitting shaft.
According to some embodiments, the support base comprises two eyelets through which the adjustable arms and/or the scallop adjustment arms extend.
According to some embodiments, the frame comprises eyelets through which the scallop adjustment arms extend.
According to some embodiments, the eyelets are extending radially inward.
According to some embodiments, the eyelets comprises internal threads.
According to some embodiments, the tabs are wrapped over the adjustable arms.
According to some embodiments, each adjustable arm comprises a plurality of apertures.
According to some embodiments, the apertures are axially spaced apart from each other.
According to some embodiments, the tabs are sutured to the adjustable arms via sutures through the tabs and the apertures.
According to some embodiments, the sutures extend through portions of the tab disposed over opposite sides of the adjustment arms.
According to some embodiments, portions of the cusp edges are wrapped over the scallop adjustment arms.
According to some embodiments, each scallop adjustment arm comprises a plurality of apertures.
According to some embodiments, the apertures are axially spaced apart from each other.
According to some embodiments, the tabs are sutured to the scallop adjustment arms via sutures through the portions of the cusp edges and the apertures.
According to some embodiments, the sutures extend through portions of the cusp edge disposed over opposite sides of the scallop adjustment arms.
According to some embodiments, each engagement portion comprises a non-cylindrical socket.
According to some embodiments, each engagement portion comprises a proximally oriented extension formed as a drive-screw coupler.
According to some embodiments, each engagement portion comprises an angled surface.
According to some embodiments, both adjustable arms of a single adjustable commissural support are laterally spaced from each other and define a gap therebetween.
According to some embodiments, two tabs of adjacent leaflets of the leaflet assembly are attached to the adjustable commissure support, such that each tab is wrapped over one of the adjustable arms.
According to some embodiments, both tabs are wrapped over the respective adjustable arms in opposite directions with respect to each other.
According to some embodiments, the gap is at least two times larger than the thickness of the tabs.
According to some embodiments, the gap is at least four times larger than the thickness of the tabs.
According to some embodiments, the gap is at least six times larger than the thickness of the tabs.
According to some embodiments, the gap is at least eight times larger than the thickness of the tabs.
According to another aspect of the invention, there is provided a prosthetic valve comprising a frame movable between a radially compressed configuration and a radially expanded configuration, a leaflet assembly mounted within the frame, at least one adjustable commissure supports, and at least one expansion and locking mechanism.
The leaflet assembly comprises a plurality of leaflets configured to regulate flow through the prosthetic valve. Each leaflet comprises a rounded cusp end portion defining a cusp edge, a free edge opposite to the cusp edge, and a pair of oppositely-directed tabs separating the cusp edge and the free edge.
The adjustable commissure support comprises a clamp coupled, directly or indirectly, to the frame at a first location, and a couple of adjustable arms. The clamp comprises a clamp mid-portion and a couple of opposing side arms continuously extending from the clamp mid-portion. Each adjustable arm extending proximally from one of the side arms. Each adjustable arm comprises an engagement portion.
The expansion and locking mechanism comprises an outer member and an inner member. The outer member comprises an outer member coupling recess, wherein the clamp of the adjustable commissure support is clamped over the outer member coupling recess. The inner member is coupled to the frame at a second location spaced apart from the first location. The inner member extends at least partially into the outer member.
Movement of the inner member in a first direction, relative to the outer member, causes the frame to foreshorten axially and expand radially. The side arms are resiliently expandable away from each other, and are inwardly biased toward each other in the absence of an expanding force applied thereto.
The tabs are attached to the adjustable arms. The adjustable arms are configured to rotate or twist when rotational force is applied to the engagement portions. Rotation or twisting of the adjustable arms causes the tabs attached thereto, to wind around the adjustable arms.
According to some embodiments, the clamp mid-portion comprises an opening, wherein the outer member comprises an outer member fastening extension extending radially outward through the opening, and coupled to the frame at the first location.
According to some embodiments, the clamp mid-portion comprises a commissure support fastening extension, extending radially outward from the clamp mid-portion, and coupled to the frame at the first location.
According to some embodiments, the outer member coupling recess has a depth which is equal to, or greater than, the thickness of the clamp.
According to some embodiments, the outer member coupling recess has a height which is not greater than 110% of the height of the clamp.
According to some embodiments, the tabs are wrapped over the adjustable arms.
According to some embodiments, each adjustable arm has a non-circular cross section.
According to some embodiments, each adjustable arm comprises a plurality of apertures.
According to some embodiments, the apertures are axially spaced apart from each other.
According to some embodiments, the tabs are sutured to the adjustable arms via sutures through the tabs and the apertures.
According to some embodiments, the sutures extend through portions of the tab disposed over opposite sides of the adjustment arms.
According to some embodiments, the engagement portion comprises a non-cylindrical socket.
According to some embodiments, the engagement portion comprises a proximally oriented extension formed as a drive-screw coupler.
According to some embodiments, the engagement portion comprises an angled surface.
According to some embodiments, the adjustable arms are rigidly attached to the side arms.
According to some embodiments, the adjustable arms are integrally formed with the side arms.
According to some embodiments, the adjustable arms are configured to twist between the side arms and the engagement portions, upon application of rotational force to the engagement portions.
According to some embodiments, the adjustable arms comprise a plastically deformable material.
According to some embodiments, the adjustable arms are rotationally coupled to the side arms.
According to some embodiments, the adjustable arms are threadedly coupled to the side arms.
According to some embodiments, each side arm comprises a base threaded portion, wherein each adjustable arm comprises an adjustable arm threaded portion, configured to threadedly engage with the base threaded portion.
According to some embodiments, both adjustable arms of a single adjustable commissural support are laterally spaced from each other and define a gap therebetween.
According to some embodiments, two tabs of adjacent leaflets of the leaflet assembly are attached to the adjustable commissure support, such that each tab is wrapped over one of the adjustable arms.
According to some embodiments, both tabs are wrapped over the respective adjustable arms in opposite directions with respect to each other.
According to some embodiments, the gap is at least two times larger than the thickness of the tabs.
According to some embodiments, the gap is at least four times larger than the thickness of the tabs.
According to some embodiments, the gap is at least six times larger than the thickness of the tabs.
According to some embodiments, the gap is at least six times larger than the thickness of the tabs.
According to some embodiments, the gap, at a free state of the side arms, is smaller than a width of the outer member at the region of the outer member coupling recess.
According to some embodiments, the adjustable arms are offset radially inward with respect to the outer member, defining an offsetting gap therebetween.
According to some embodiments, the offsetting gap is larger than the thickness of the tab.
According to some embodiments, the offsetting gap is at least two times larger than the thickness of the tab.
According to some embodiments, the offsetting gap is at least three times larger than the thickness of the tab.
According to some embodiments, the offsetting gap is at least four times larger than the thickness of the tab.
According to another aspect of the invention, there is provided a delivery assembly comprising a prosthetic valve and a delivery apparatus. The prosthetic valve comprises a frame movable between a radially compressed configuration and a radially expanded configuration, a leaflet assembly mounted within the frame, and a plurality of adjustable commissure supports.
The leaflet assembly comprises a plurality of leaflets configured to regulate flow through the prosthetic valve. Each leaflet comprises a rounded cusp end portion defining a cusp edge, a free edge opposite to the cusp edge, and a pair of oppositely-directed tabs separating the cusp edge and the free edge.
Each adjustable commissure support comprises a support base attached to the frame, and at least one adjustable arm extending proximally from the support base. Each adjustable arm comprises an engagement portion.
The delivery apparatus comprises a handle, a delivery shaft extending distally from the handle, and at least one adjustment assembly extending from the handle through the delivery shaft. The adjustment assembly comprises at least one adjustment arm equipped with a driving head. The driving head is releasably coupled to the engagement portion.
The tabs are attached to the adjustable arms. Rotational force applied to the adjustment arms is configured to rotate the engagement portions therewith, thereby causing the adjustable arms to rotate or twist. Rotation or twisting of the adjustable arms causes the tabs attached thereto, to wind around the adjustable arms.
According to some embodiments, the adjustment arm is a torque transmitting arm, configured to transmit torque from the handle to the engagement portion.
According to some embodiments, each adjustment assembly further comprises an adjustment sleeve extending over the adjustment arm.
According to some embodiments, the adjustment sleeve and the adjustment arms are movable longitudinally relative to each other.
According to some embodiments, the tabs are wrapped over the adjustable arms.
According to some embodiments, each adjustable arm has a non-circular cross section.
According to some embodiments, each adjustable arm comprises a plurality of apertures.
According to some embodiments, the apertures are axially spaced apart from each other.
According to some embodiments, the tabs are sutured to the adjustable arms via sutures through the tabs and the apertures.
According to some embodiments, the sutures extend through portions of the tab disposed over opposite sides of the adjustment arms.
According to some embodiments, the engagement portion comprises a non-cylindrical socket.
According to some embodiments, the driving head comprises a distally oriented non-circular extension, dimensioned to be inserted into the socket.
According to some embodiments, the engagement portion comprises a proximally oriented extension formed as a drive-screw coupler.
According to some embodiments, the engagement portion comprises an angled surface.
According to some embodiments, the driving head comprises a distally oriented extension formed as a drive-screw coupler, complementary to the drive-screw coupler shape of the engagement portion.
According to some embodiments, the adjustable arms are rigidly attached to the support base.
According to some embodiments, the adjustable arms are integrally formed with the support base.
According to some embodiments, the adjustable arms are configured to twist between the support base and the engagement portions, upon application of rotational force to the engagement portions.
According to some embodiments, the adjustable arms comprise a plastically deformable material.
According to some embodiments, the adjustable arms are rotationally coupled to the support base.
According to some embodiments, the adjustable arms are threadedly coupled to the support base.
According to some embodiments, the support base comprises at least one base threaded portion, wherein each adjustable arm comprises an adjustable arm threaded portion, configured to threadedly engage with the base threaded portion.
According to some embodiments, the support base further comprises at least one offsetting extension, extending radially therefrom, wherein the at least one adjustable arm extends from the respective offsetting extension.
According to some embodiments, the at least one offsetting extension extends radially away from the support base.
According to some embodiments, the at least one offsetting extension extends radially inward with respect to the support base.
According to some embodiments, the offsetting extension is integrally formed with the support base.
According to some embodiments, each adjustable commissure support comprises a single adjustable arm.
According to some embodiments, two tabs of adjacent leaflets of the leaflet assembly are attached to the adjustable commissure support, such that both tabs are wrapped over the single adjustable arm.
According to some embodiments, the leaflets are asymmetric leaflets, each asymmetric leaflet having a short tab and an opposite long tab, wherein the tabs of adjacent leaflets are wrapped over the single adjustable arm such that the short tab of one leaflet is wrapped around the adjustable arm, in direct contact therewith, and the long tab of the adjacent leaflet is wrapped over the short tab.
According to some embodiments, each adjustment assembly comprises a single adjustment arm.
According to some embodiments, each adjustable commissure support comprises two adjustable arms that are laterally spaced from each other and define a gap therebetween.
According to some embodiments, two tabs of adjacent leaflets of the leaflet assembly are attached to the adjustable commissure support, such that each tab is wrapped over one of the adjustable arms.
According to some embodiments, both tabs are wrapped over the respective adjustable arms in opposite directions with respect to each other.
According to some embodiments, each adjustment assembly comprises two adjustment arms.
According to another aspect of the invention, there is provided a delivery assembly comprising a prosthetic valve and a delivery apparatus. The prosthetic valve comprises a frame movable between a radially compressed configuration and a radially expanded configuration, a leaflet assembly mounted within the frame, at least one adjustable commissure support, and at least one expansion and locking assembly.
The leaflet assembly comprises a plurality of leaflets configured to regulate flow through the prosthetic valve. Each leaflet comprises a rounded cusp end portion defining a cusp edge, a free edge opposite to the cusp edge, and a pair of oppositely-directed tabs separating the cusp edge and the free edge.
The adjustable commissure support comprises a clamp coupled, directly or indirectly, to the frame at a first location, and a couple of adjustable arms. The clamp comprises a clamp mid-portion and a couple of opposing side arms continuously extending from the clamp mid-portion. Each adjustable arm extending proximally from one of the side arms. Each adjustable arm comprises an engagement portion.
The expansion and locking mechanism comprises an outer member and an inner member. The outer member comprises an outer member coupling recess, wherein the clamp of the adjustable commissure support is clamped over the outer member coupling recess. The inner member is coupled to the frame at a second location spaced apart from the first location. The inner member extends at least partially into the outer member.
The delivery apparatus comprises a handle, a delivery shaft extending distally from the handle, and at least one adjustment assembly extending from the handle through the delivery shaft. The adjustment assembly comprises at least one adjustment arm equipped with a driving head. The driving head is releasably coupled to the engagement portion.
Movement of the inner member in a first direction, relative to the outer member, causes the frame to foreshorten axially and expand radially. The side arms are resiliently expandable away from each other, and are inwardly biased toward each other in the absence of an expanding force applied thereto.
The tabs are attached to the adjustable arms. Rotational force applied to the adjustment arms is configured to rotate the engagement portions therewith, thereby causing the adjustable arms to rotate or twist. Rotation or twisting of the adjustable arms causes the tabs attached thereto, to wind around the adjustable arms.
According to some embodiments, the clamp mid-portion comprises an opening, and the outer member comprises an outer member fastening extension extending radially outward through the opening, and coupled to the frame at the first location.
According to some embodiments, the clamp mid-portion comprises a commissure support fastening extension, extending radially outward from the clamp mid-portion, and coupled to the frame at the first location.
According to some embodiments, the outer member coupling recess has a depth which is equal to, or greater than, the thickness of the clamp.
According to some embodiments, the outer member coupling recess has a height which is not greater than 110% of the height of the clamp.
According to some embodiments, the tabs are wrapped over the adjustable arms.
According to some embodiments, each adjustable arm has a non-circular cross section.
According to some embodiments, each adjustable arm comprises a plurality of apertures.
According to some embodiments, the apertures are axially spaced apart from each other.
According to some embodiments, the tabs are sutured to the adjustable arms via sutures through the tabs and the apertures.
According to some embodiments, the sutures extend through portions of the tab disposed over opposite sides of the adjustment arms.
According to some embodiments, the engagement portion comprises a non-cylindrical socket.
According to some embodiments, the driving head comprises a distally oriented non-circular extension, dimensioned to be inserted into the socket.
According to some embodiments, the engagement portion comprises a proximally oriented extension formed as a drive-screw coupler.
According to some embodiments, the engagement portion comprises an angled surface.
According to some embodiments, the driving head comprises a distally oriented extension formed as a drive-screw coupler, complementary to the drive-screw coupler shape of the engagement portion.
According to some embodiments, the adjustable arms are rigidly attached to the side arms.
According to some embodiments, the adjustable arms are integrally formed with the side arms.
According to some embodiments, the adjustable arms are configured to twist between the side arms and the engagement portions, upon application of rotational force to the engagement portions.
According to some embodiments, the adjustable arms comprise a plastically deformable material.
According to some embodiments, the adjustable arms are rotationally coupled to the side arms.
According to some embodiments, the adjustable arms are threadedly coupled to the side arms.
According to some embodiments, each side arm comprises a base threaded portion, wherein each adjustable arm comprises an adjustable arm threaded portion, configured to threadedly engage with the base threaded portion.
According to some embodiments, both adjustable arms of a single adjustable commissural support are laterally spaced from each other and define a gap therebetween.
According to some embodiments, two tabs of adjacent leaflets of the leaflet assembly are attached to the adjustable commissure support, such that each tab is wrapped over one of the adjustable arms.
According to some embodiments, both tabs are wrapped over the respective adjustable arms in opposite directions with respect to each other.
According to some embodiments, the gap is at least two times larger than the thickness of the tabs.
According to some embodiments, the is at least four times larger than the thickness of the tabs.
According to some embodiments, the gap is at least six times larger than the thickness of the tabs.
According to some embodiments, the gap is at least eight times larger than the thickness of the tabs.
According to some embodiments, the gap, at a free state of the side arms, is smaller than a width of the outer member at the region of the outer member coupling recess.
According to some embodiments, the adjustable arms are offset radially inward with respect to the outer member, defining an offsetting gap therebetween.
According to some embodiments, the offsetting gap is larger than the thickness of the tab.
According to some embodiments, the offsetting gap is at least two times larger than the thickness of the tab.
According to some embodiments, the offsetting gap is at least three times larger than the thickness of the tab.
According to some embodiments, the offsetting gap is at least four times larger than the thickness of the tab.
According to some embodiments, the adjustment arm is a torque transmitting arm, configured to transmit torque from the handle to the engagement portion.
According to some embodiments, each adjustment assembly further comprises an adjustment sleeve extending over the adjustment arm.
According to some embodiments, the adjustment sleeve and the adjustment arms are movable longitudinally relative to each other.
According to another aspect of the invention, there is provided a commissure adjustment assembly, comprising a valve holder and an adjustment handle, releasably attachable to the valve holder. The valve holder comprises annular holder body, configured to accommodate a prosthetic valve therein.
The adjustment handle comprises an annular driver gear, a plurality of pinion gears rotatable by the driver gear, and a plurality of driving rods, wherein each driving rod extends from a corresponding pinion gear. Each driving rod comprises a driving head, configured to engage with an engagement portion of an engagement portion of adjustable arms of the valve.
According to some embodiments, the valve holder comprises at least one recess, wherein the adjustment handle comprises at least one clamp configured to engage with the at least one recess.
According to some embodiments, the adjustment handle further comprises a handle knob, configured to facilitate rotation of the driver gear.
According to some embodiments, the handle knob and the driver gear are integrally formed.
According to some embodiments, the driver gear is an internal gear having internal teeth, and the pinion gears are external gears having external teeth, such that the teeth of at least some of the pinion gears are meshed with the teeth of the driver gear.
According to some embodiments, the pinion gears comprise primary pinion gears meshed with the driver gear.
According to some embodiments, the prosthetic valve positioned within the valve holder, wherein the prosthetic valve comprises a plurality of adjustable commissure supports. Each adjustable commissure support comprises a single adjustable arm having the engagement portion, wherein the driving head of each driving rod extending from a primary pinion gear is engaged with a corresponding engagement portion.
According to some embodiments, the commissure adjustment assembly further comprises the prosthetic valve positioned within the valve holder, wherein the prosthetic valve comprises a plurality of adjustable commissure supports, and wherein each adjustable commissure support comprises two adjustable arm having engagement portions. The driving head of each driving rod extending from a primary pinion gear is engaged with an engagement portion of one adjustable arm of an adjustable engagement support, wherein each two of the plurality of primary pinion gears having their driving rods engaged with two adjustable arms of the same adjustable commissure supports, are not meshed with each other, and are having their driving rods spaced apart from each other by a gap that is equal to the gap between the respective engagement arms they are engaged with.
According to some embodiments, the pinion gears further comprise secondary pinion gears, which are meshed with the primary pinion gears, but not with the secondary pinion gears.
According to some embodiments, the commissure adjustment assembly further comprises the prosthetic valve positioned within the valve holder, wherein the prosthetic valve comprises a plurality of adjustable commissure supports, and wherein each adjustable commissure support comprises two adjustable arm having engagement portions. The driving head of each driving rod extending from a primary pinion gear is engaged with an engagement portion of one adjustable arm of an adjustable engagement support, wherein the driving head of each driving rod extending from the secondary pinion gear meshed with the primary pinion gear is engaged with an engagement portion of the other adjustable arm of the same adjustable engagement support.
According to another aspect of the invention, there is provided a method of assembling a commissure assembly, comprising the steps of: (1) wrapping a tab of one leaflet over a single adjustable arm extending from a support base of an adjustable commissure support of a prosthetic valve; (2) wrapping another tab of an adjacent leaflet over the previous tab; and (3) suturing both tabs to the adjustable arm via a suture extending through both tabs and apertures of the adjustable arm.
According to some embodiments, the step of suturing includes passing the suture through portions of the tabs disposed over opposite sides of the adjustment arm.
According to some embodiments, the step of wrapping a tab of one leaflet over the adjustable arm comprises wrapping a short tab of the one leaflet over the adjustable arm, and wherein the step of wrapping another tab includes wrapping a long tab of the adjacent leaflet over the short tab.
According to another aspect of the invention, there is provided a method of assembling a commissure assembly, comprising the steps of: (1) extending two tabs of two adjacent leaflets through a gap of an adjustable commissure support; (2) wrapping each tab over a respective adjustable arm, wherein both tabs are wrapped in opposite directions with respect to each other; and (3) suturing each tab to the respective adjustable arm via a suture extending through the tab and apertures of the adjustable arm.
According to some embodiments, the step of suturing includes passing the suture through portions of the tab disposed over opposite sides of the adjustment arm.
According to another aspect of the invention, there is provided a method for adjusting the tension of leaflets of a prosthetic valve, comprising the steps of: (1) placing a prosthetic valve having a plurality of adjustable commissure supports, within a valve holder of a commissure adjustment assembly; (2) releasably coupling an adjustment handle to the valve holder, such that driving heads of driving rods extending from pinion gears that are positioned within a driver gear, engage with engagement portions of adjustable arms of the adjustable commissure supports; and (3) rotating the driver gear to facilitate rotation of the pinion gears rotatable thereby, which in turn rotate the engagement portions therewith.
According to some embodiments, the step of placing the prosthetic valve within the valve holder, includes a step of expanding the prosthetic valve against the annular holder body of the valve holder.
According to some embodiments, each adjustable commissure support includes a single adjustable arm, wherein the pinion gears include primary pinion gears meshed with the driver gear. The step of coupling includes engaging the driving heads of the driving rods extending from the primary pinion gears with the engagement portions of the single adjustable arms of the adjustable commissure supports. The step of rotating includes rotating the driver gear to facilitate rotation of the primary pinion gears meshed therewith.
According to some embodiments, each adjustable commissure support includes two adjustable arms, wherein the pinion gears include primary pinion gears meshed with the driver gear, and secondary pinion gears meshed with the primary pinion gears but not with the driver gear. The step of coupling includes engaging the driving head of the driving rod extending from each primary pinion gear with one adjustable arm of an adjustable commissure support, and engaging the driving head of the driving rod extending from the secondary pinion gear meshed with the with the primary pinion gear, with the other adjustable arm of the same adjustable commissure support. The step of rotating includes rotating the driver gear to facilitate rotation of the primary pinion gears and the secondary pinion gears in opposite rotational directions.
According to another aspect of the invention, there is provided a method for adjusting the tension of leaflets of a prosthetic valve, comprising the steps of: (1) expanding a prosthetic valve that includes a plurality of adjustable commissure supports, to a final expanded diameter; (2) rotating adjustment arms that extend from a handle of a delivery apparatus, and are coupled via driving heads thereof to adjustment portions of adjustable arms of the adjustable commissure supports, to facilitate rotation of the engagement portions therewith; and (3) disengaging the driving heads from the adjustment portions.
According to some embodiments, the step of disengaging the driving heads includes pulling the driving heads proximally away from the engagement portions.
According to some embodiments, the step of disengaging the driving heads includes pulling adjustment sleeves that are disposed over the adjustment arms in a proximal direction.
According to some embodiments, the step of disengaging the driving heads includes simultaneously pulling the adjustment arms with adjustment sleeves disposed thereover.
According to some embodiments, the step of rotating the adjustment arms includes rotating each couple of adjustment arms engaged with two adjustable arms that extend from a single support base, in opposite rotational directions.
According to some embodiments, the method further comprises a step of retrieving the delivery apparatus.
The various innovations of this disclosure can be used in combination or separately. This summary is provided to introduce a selection of concepts in a simplified form that are further described below in the detailed description. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. The foregoing and other objects, features, and advantages of the invention will become more apparent from the following detailed description, which proceeds with reference to the accompanying figures.
Some embodiments of the invention are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some embodiments may be practiced. The figures are for the purpose of illustrative description and no attempt is made to show structural details of an embodiment in more detail than is necessary for a fundamental understanding of the invention. For the sake of clarity, some objects depicted in the figures are not to scale.
In the Figures:
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. The technologies from any example can be combined with the technologies described in any one or more of the other examples. In view of the many possible embodiments to which the principles of the disclosed technology 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 disclosed technology.
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.
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 terms “have” or “includes” means “comprises.” As used herein, “and/or” means “and” or “or,” as well as “and” and “or”.
Directions and other relative references may be used to facilitate discussion of the drawings and principles herein, but are not intended to be limiting. For example, certain terms may be used such as “inner,” “outer,” “upper,” “lower,” “inside,” “outside,”, “top,” “bottom,” “interior,” “exterior,” “left,” right,” and the like. Such terms are used, where applicable, to provide some clarity of description when dealing with relative relationships, particularly with respect to the illustrated embodiments. Such terms are not, however, intended to imply absolute relationships, positions, and/or orientations. For example, with respect to an object, an “upper” part can become a “lower” part simply by turning the object over. Nevertheless, it is still the same part and the object remains the same.
Throughout the figures of the drawings, different superscripts for the same reference numerals are used to denote different embodiments of the same elements. Embodiments of the disclosed devices and systems may include any combination of different embodiments of the same elements. Specifically, any reference to an element without a superscript may refer to any alternative embodiment of the same element denoted with a superscript. In order to avoid undue clutter from having too many reference numbers and lead lines on a particular drawing, some components will be introduced via one or more drawings and not explicitly identified in every subsequent drawing that contains that component.
The term “proximal”, as used herein, generally refers to the side or end of any device or a component of a device, which is closer to the handle 30 or an operator of the handle 30 when in use.
The term “distal”, as used herein, generally refers to the side or end of any device or a component of a device, which is farther from the handle 30 or an operator of the handle 30 when in use.
The term “prosthetic valve”, as used herein, refers to any type of a prosthetic valve deliverable to a patient’s target site over a catheter, which is radially expandable and compressible between a radially compressed, or crimped, state, and a radially expanded state. Thus, a prosthetic valve 100 can be crimped or retained by a delivery apparatus 12 in a compressed state during delivery, and then expanded to the expanded state once the prosthetic valve 100 reaches the implantation site. The expanded state may include a range of diameters to which the valve may expand, between the compressed state and a maximal diameter reached at a fully expanded state. Thus, a plurality of partially expanded states may relate to any expansion diameter between radially compressed or crimped state, and maximally expanded state.
The term “plurality”, as used herein, means more than one.
A prosthetic valve 100 of the current disclosure may include any prosthetic valve configured to be mounted within the native aortic valve, the native mitral valve, the native pulmonary valve, and the native tricuspid valve. While a delivery assembly 10 described in the current disclosure, includes a delivery apparatus 12 and a prosthetic valve 100, it should be understood that the delivery apparatus 12 according to any embodiment of the current disclosure can be used for implantation of other prosthetic devices aside from prosthetic valves, such as stents or grafts.
A catheter deliverable prosthetic valve 100 can be delivered to the site of implantation via the delivery assembly 10 carrying the valve 100 in a radially compressed or crimped state, toward the target site, to be mounted against the native anatomy, by expanding the prosthetic valve 100 via various expansion mechanisms. Balloon expandable valves generally involve a procedure of inflating a balloon within a prosthetic valve, thereby expanding the prosthetic valve 100 within the desired implantation site. Once the valve is sufficiently expanded, the balloon is deflated and retrieved along with the delivery apparatus 12. Self-expandable valves include a frame that is shape-set to automatically expand as soon an outer retaining capsule, which may be also defined as the distal portion of an outer shaft (20) or the distal portion of a delivery shaft, is withdrawn proximally relative to the prosthetic valve. Mechanically expandable valves are a category of prosthetic valves that rely on a mechanical actuation mechanism for expansion. The mechanical actuation mechanism usually includes a plurality of expansion and locking assemblies, releasably coupled to respective actuation assemblies of the delivery apparatus 12, controlled via the handle 30 for actuating the expansion and locking assemblies to expand the prosthetic valve to a desired diameter. The expansion and locking assemblies may optionally lock the valve’s diameter to prevent undesired recompression thereof, and disconnection of the actuation assemblies from the expansion and locking assemblies, to enable retrieval of the delivery apparatus 12 once the prosthetic valve is properly positioned at the desired site of implantation.
The delivery assembly 10 can be utilized, for example, to deliver a prosthetic aortic valve for mounting against the aortic annulus, to deliver a prosthetic mitral valve for mounting against the mitral annulus, or to deliver a prosthetic valve for mounting against any other native annulus.
The exemplary delivery assembly 10 illustrated in
The outer shaft 20 and the balloon catheter 24 can be configured to be axially movable relative to each other, such that a proximally oriented movement of the outer shaft 20 relative to the balloon catheter 24, or a distally oriented movement of the balloon catheter 24 relative to the outer shaft 20, can expose the prosthetic valve 100a from the outer shaft 20.
The proximal ends of the balloon catheter 24, and when present - the outer shaft 20, can be coupled to the handle 30a. During delivery of the prosthetic valve 100a, the handle 30a can be maneuvered by an operator (e.g., a clinician or a surgeon) to axially advance or retract components of the delivery apparatus 12a, such as the nosecone shaft 26, the balloon catheter 24, and/or the outer shaft 20, through the patient’s vasculature, as well as to inflate the balloon mounted on the balloon catheter 24, so as to expand the prosthetic valve 100a, and to deflate the balloon and retract the delivery apparatus 12a once the prosthetic valve 100a is mounted in the implantation site.
According to some embodiments, the handle 30 can include one or more operating interfaces, such as steerable or rotatable adjustment knobs 32, levers, sliders, buttons and other actuating mechanisms, which are operatively connected to different components of the delivery apparatus 12 and configured to produce axial movement of components of the delivery apparatus 12 in the proximal and distal directions, as well as to expand or contract the prosthetic valve 100 via various mechanisms. For example, a handle 30a can include rotatable or otherwise maneuverable knobs 32a for axially moving the nosecone shaft 26, the balloon catheter 24, the outer shaft 20, and/or to inflate and deflate the inflatable balloon.
The term “outflow”, as used herein, refers to a region of the prosthetic valve through which the blood flows through and out of the valve 100, for example between the valve’s central longitudinal axis and the outflow end 102.
The term “inflow”, as used herein, refers to a region of the prosthetic valve through which the blood flows into the valve 100, for example between inflow end 104 and the valve’s central longitudinal axis.
The valve 100 comprises an annular frame 106 movable between a radially compressed configuration and a radially expanded configuration, and a leaflet assembly 124 mounted within the frame 106. The frame 106 can be made of various suitable materials, including plastically-deformable materials such as, but not limited to, stainless steel, a nickel based alloy (e.g., a cobalt-chromium or a nickel-cobalt-chromium alloy such as MP35N alloy), polymers, or combinations thereof. When constructed of a plastically-deformable materials, the frame 106 can be crimped to a radially compressed state on a balloon catheter 24, and then expanded inside a patient by an inflatable balloon or equivalent expansion mechanism. Alternatively or additionally, the frame 106 can be made of shape-memory materials such as, but not limited to, nickel titanium alloy (e.g., Nitinol). When constructed of a shape-memory material, the frame 106 can be crimped to a radially compressed state and restrained in the compressed state by insertion into a shaft or equivalent mechanism of a delivery apparatus 12.
In the example illustrated in
The end portions of the struts 110 are forming apices 118 at the outflow end 102 and apices 116 at the inflow end 104. The struts 110 can intersect at additional junctions 114 formed between the outflow apices 118 and the inflow apices 116. The junctions 114 can be equally or unequally spaced apart from each other, and/or from the apices 118, 116, at the outflow end 102 and the inflow end 104.
According to some embodiments, the struts 110 include a plurality of angled struts and axial struts (113).
The leaflet assembly 124 comprises a plurality of leaflets 126 (e.g., three leaflets), positioned at least partially within the frame 106, and configured to regulate flow of blood through the prosthetic valve 100 from the inflow end 104 to the outflow end 102. While three leaflets 126 arranged to collapse in a tricuspid arrangement, are shown in the exemplary embodiment illustrated in
When the leaflets 126 are coupled to the frame and to each other, the lower edge of the resulting leaflet assembly 124 desirably has an undulating, curved scalloped shape. By forming the leaflets with this scalloped geometry, stresses on the leaflets 126 are reduced which, in turn, improves durability of the valve. Moreover, by virtue of the scalloped shape, folds and ripples at the belly of each leaflet, which can cause early calcification in those areas, can be eliminated or at least minimized. The scalloped geometry also reduces the amount of tissue material used to form the leaflet structure, thereby allowing a smaller, more even crimped profile at the inflow end of the valve.
A conventional leaflet 126, such as leaflet 126a shown in
The leaflets 126 define a non-planar coaptation plane (not annotated) when their free edges 130 co-apt with each other to seal blood flow through the prosthetic valve 100. Leaflets 126 can be secured to one another at their tabs 132 to form commissure assemblies 134 of the leaflet assembly 124, which can be secured, directly or indirectly, to structural elements connected to the frame 106 or embedded therein, such as commissure posts or commissure windows. When secured to two other leaflets 126 to form leaflet assembly 124, the cusp edges 128 of the leaflets 126 collectively form the scalloped shaped lower edge portion of the leaflet assembly 124.
According to some embodiments, such as the exemplary embodiment illustrated in
Additional frame configurations may include commissure posts attached to the frame, configured to accept commissure assemblies 134 extending either through window portions defined therein, or supporting commissure assembly attachment thereto in various other manners. Alternatively, some of the cells 108 may be configured to receive commissure assemblies 134 attached thereto. For example, the uppermost row of cells 108 can be configured to receive tabs 132 of the leaflets 126. Further details regarding prosthetic valves, including the manner in which commissures may be mounted to their frames, are described in U.S. Pat. Nos. 6,730,118, 7,393,360, 7,510,575, 7,993,394, 8,252,202, and 9,393,110; U.S. Publication Nos. 2018/0325665, 2019/0105153, U.S. Application Nos. 62/869,948 and 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 commissure assemblies 134, directly or indirectly, to the frame 106.
According to some embodiments, the prosthetic valve 100 further comprises an inner skirt 122 that can be secured to the inner surface of the frame 106. The inner skirt 122 is configured to assist in securing the leaflet assembly 124 to the frame 106 and to assist in forming a good seal between the prosthetic valve (100) and the native annulus by blocking the flow of blood through the open cells 108 of the frame (106) below the cusp edges 128 of the leaflets (126). The leaflets 126 may be sutured to the inner skirt 122 via a scallop-line suture that tracks their lower cusp edges 128, while the inner skirt 122 can be sutured to the frame 106 at locations away from the scallop-line suture so that the inner skirt 122 can be more pliable in that area. This can avoid stress concentrations at the scallop-line suture.
According to some embodiments, the prosthetic valve 100 can further comprise an outer skirt (not shown) mounted on the outer surface of the frame 106, configure to function, for example, as a sealing member retained between the frame 106 and the surrounding tissue of the native annulus against which the prosthetic valve 100 is mounted, thereby reducing risk of paravalvular leakage past the prosthetic valve 100. Either one of the inner skirt (122) or the outer skirt can be made of various suitable biocompatible materials, such as, but not limited to, various synthetic materials (e.g., PET) or natural tissue (e.g. bovine pericardium).
The leaflets 126 define a non-planar coaptation plane (not annotated) when their free edges 130 coapt with each other to seal blood flow through the prosthetic valve 100. In some implementations, the free edge 130 of a leaflet 126 can extend along a straight line between the tabs 132. In other implementations, as shown in
During diastole, the adjacent free edges 130 should coapt with each other during diastole, to prevent retrograde blood from flowing between the free edges 130. During systole, the adjacent free edges 130 will separate from each other and allow antegrade blood to flow between free edges 130 and help wash away blood from the areas underneath the commissure assemblies 134.
While described and shown throughout the figures with respect to the free edges 130 of adjacent leaflets 126, it is to be understood that any reference within the current specification, to coaptation between leaflets 126, is not limited to the free edges 130 contacting each other, but may also refer to other regions of the leaflets 126, which can be adjacent and distal to the free edges 130, for example, that contact each other in a closed position (i.e., during diastole) in a manner that will prevent retrograde blood flow through the prosthetic valve (100).
Some types of prosthetic valves are adapted for use in a range of expansion diameters, instead of being configured to be usable for a specific single expansion diameter. For example, one type of prosthetic valves can be sized for implantation in a range of diameters from 23 to 26 mm, while another type of the of prosthetic valves can be sized for implantation in a range of diameters from 26 to 29 mm. While the frame (106) can be easily expandable, and potentially lockable, in a relatively wide range of expansion diameters, the coaptation between the leaflets (126) is less flexible, such that over-expansion or under-expansion of the frame may result in impaired coaptation between the leaflets 126.
In
Disclosed herein are prosthetic valves that include adjustable commissure supports, configured to adjust the length of the free edges between the commissural assemblies attached to the adjustable commissure supports, so as to facilitate adequate coaptation between the leaflets in a chosen diameter or a chosen range of diameters.
The adjustable commissure support 160 may further include support base 172, from which the at least one adjustable arm 162. Preferably, the at least one adjustable arm 162 is vertically oriented, parallel to a longitudinal axis of the valve. The at least one adjustable arm 162 preferably extends proximally from the support base 172.
According to some embodiments, the adjustable commissure support 160 comprises two adjustable arms 162a and 162b, circumferentially or laterally spaced apart from each other so as to define a gap G′ there-between, as shown in
According to some embodiments, the frame 106b comprises a plurality of adjustable commissure supports 160, configured to accommodate a plurality of commissure assemblies (134). While three adjustable commissure supports 160 are illustrated, it will be understood that any other number of adjustable commissure supports 160 is contemplated.
According to some embodiments, the adjustable commissure supports 160 are at the level of the upper (i.e., proximal) row of cells 108ba. According to some embodiments, the upper row of cells 108ba includes axially extending struts (113), and the adjustable commissure supports 160 are positioned between cells 108b with axially extending struts (113), wherein the adjustable arms 162 are parallel to the axially extending struts (113). According to some embodiments, the cells defined on both sides of each adjustable commissure supports 160 are open cells (108), that are open ended at their proximal end, and are thereby devoid of outflow apices.
According to some embodiments, the support base 172 is integrally formed with the frame 106. According to some embodiments, the support base 172 is formed as an integral portion of a junction 114 (as illustrated in
Each adjustable arm 162 comprises an engagement portion 166, preferably positioned at a proximal end thereof. The engagement portion 166 is configured to non-rotatably engage with an external component, such that rotation of the external component around its axis will serve to rotate or twist the adjustable arm 162 in the same direction.
According to some embodiments, the engagement portion 166 comprises a non-cylindrical socket 168, configured to accommodate a tool therein, to facilitate rotation or twisting of the adjustable arm 162. Sockets 168a and 168b are illustrated as rectangular sockets by way of illustration and not limitation. A socket 168 can have any of various shapes provided with at least one facet, so as to facilitate rotation thereof when a tool or component accommodated therein, having a complementary shape, is rotated.
A socket 168 can be in the form of a screw-drive socket, having at least one facet. In some implementations, a socket 168 can be in the form of a Phillips or a Fearson screw-drive socket. In some implementations, a socket 168 can be in the form of a hex or an Allen screwhead socket. In some implementations, a socket 168 can be in the form of a screw driver socket such as, but not limited to: Slot, Square, Robertson, Torx, TA, Tri-Wing, Clutch, Spanner-Head, Double-Square, Triple-Square, Double-Hex, Bristol and the like.
While illustrated as a socket 168 in
The adjustable arms 162 illustrated in
According to some embodiments, the adjustable commissure supports 160 do not extend proximally beyond the level of the outflow end 102. According to some embodiments, the adjustable commissure supports 160 do not extend proximally beyond the level of the outflow apices 118.
According to some embodiments, the adjustable commissure supports 160 is configured to accommodate a commissural assembly 134. The at least one adjustable arm 162 is configured to attach with at least one tab 132 of a leaflet 126, such that the at least one tab 132 will be wound around the adjustable arm 162 when the adjustable arm 162 is rotated or twisted about its central axis.
According to some embodiments, the adjustable arm 162 comprises a plurality of apertures 164, that can be axially spaced apart from each other along at least a portion of the length of the adjustable arm 162, as shown in
As further shown in
Each leaflet 126, and more specifically, tabs 132 of the leaflet (126), can have a thickness T′ (see
As further shown in
According to some embodiments, there is provided a method for assembling a commissure assembly (134), comprising steps of: (1) extending two tabs 132 of two adjacent leaflets 126 through a gap G′ of an adjustable commissure support 160; (2) wrapping each tab 132 over a respective adjustable arm 162, wherein both tabs 132 are wrapped in opposite directions with respect to each other; and (3) suturing each tab 132 to the adjustable arm 162 via a suture 176 extending through the tab 132 and apertures 164 of the adjustable arm 162. In some embodiments, the step of suturing includes passing the suture 176 through portions of the tab 132 disposed over opposite sides of the adjustable arm 162.
While the tabs 132a and 132b are shown to be wrapped around the adjustable arms 162a and 162b in opposite directions, it is to be understood that in alternative embodiments, both tabs 132a and 132b may be wrapped around the adjustable arms 162a and 162b, respectively, in the same direction. In such embodiments, both of the adjustable arms 162a and 162b are rotated in the same circumferential direction, instead of being rotated in opposite direction as shown in
The tabs 132 are attached to the respective adjustable arms 162 in a manner that prevents them from rotationally sliding over the adjustable arms 162, such that when the adjustable arms are rotated or twisted, the tabs 132 are further wrapped around the adjustable arms.
It is to be understood that the tabs 132 can be attached to the adjustable arms 162 in other manners except suturing, such as gluing and any other means of attachment known in the art, as long as the attachment between the tabs 132 and the adjustable arms 162 is performed in such a manner that when an adjustable arms 162 is rotated or twisted, the respective tab 132 attached thereto is wound thereover.
In some implementations, the adjustable arms 162 can have a non-circular cross-section, such as the rectangular cross-section shown in
Applying too much tension to the leaflets 126, by over-rotating the adjustable arms 162, may result in an over-tensioned state as shown in
The process of proper adjustment of the leaflets 126 may include numerous repeating steps of tensioning and un-tensioning the leaflets, by applying rotational movement to the adjustable arms 162 in the proper rotational directions corresponding to either tensioning or un-tensioning the leaflets 126.
In some implementations, the adjustable arms 162 can be rotated less than 360 degrees. In some implementation, the adjustable arms 162 can be rotated more than 360 degrees. In some cases, rotation of the adjustable arms 162 causes the tabs 132 to be wound over the adjustable arms 162 to such an extent that more than one layer of the tab extends through the gap G′, as shown for example in
According to some embodiments, the gap G′ is at least four times larger than the thickness T′ of the tabs 132. According to some embodiments, the gap G′ is at least six times larger than the thickness T′ of the tabs 132. According to some embodiments, the gap G′ is at least eight times larger than the thickness T′ of the tabs 132.
According to some embodiments, the adjustable arms 162 are configured to twist about their central axes, with respect to the support base 172.
As shown in
According to some embodiments, the adjustable arms 162a comprise a plastically deformable material, such that once they assume the twist configuration shown in
According to some embodiments, the adjustable arms 162 are configured to rotate about their central axes, with respect to the support base 172.
According to some embodiments, the adjustable arms 162b are threadedly coupled the support base 172b. As shown in
In the example shown in
As shown in
In some implementations of the current invention, adjustment of the leaflet assembly (124) mounted within the prosthetic valve (100) is performed prior to implantation into the patient’s body. For example, the desired expansion diameter of the valve (100) can be based on acquired anatomical data of the patient’s anatomy at the target implantation site, which can be achieved via various imaging modalities known in the art, such as pre-CT that is conventionally performed prior to initiating an implantation procedure.
The valve holder 202 may be a cup-shaped holder, comprising an annular holder body 206, and optionally a holder base 204. The holder body is dimensioned to accommodate a prosthetic valve 100 in a specific configuration of the valve, such as an expanded or partially expanded configuration. An optional holder base 204 can support the inflow end 104 of the valve (100).
The adjustment handle 210 comprises an annular driver gear 212 and a plurality of pinion gears rotatable by the driver gear 212, wherein a driving rod 218 extends from each pinion gear toward a corresponding adjustable arm 162 of the prosthetic valve 100 accommodated within the valve holder 202. Each driving rod 218 includes a driving head 220 configured to engage with an engagement portion 166 of a corresponding adjustable arm 162.
The driving heads 220 are shaped with complementary shapes to those of the engagement portions 166. For example, if the engagement portion 166 of each adjustable arm 162 comprises a socket 168, the driving head 220 is shaped as a non-cylindrical extension configured to be inserted into the socket 168, such that rotation of the driving head 220 will rotate the engagement portion 166 therewith. More specifically, if the socket 168 is shaped as a rectangular socket, as shown in
The adjustment handle 210 can include handle knob 222, which can be provided in the form of a rotatable knob, configured to facilitate rotation of the driver gear 212. The handle knob 222 can be configured to be maneuverable by an operator of the commissure adjustment assembly 200, for example by grasping the handle knob 222 and manually rotating it. In some embodiments, the handle knob 222 and the driver gear 212 are integrally formed as a single component. In alternative embodiments, the handle knob 222 and the driver gear 212 are separate components, operatively coupled to each other.
The driver gear 212 can be provided as an internal gear, wherein the pinion gears are positioned within the driver gear 212. The driver gear 212 can have internal teeth, while the pinion gears include external teeth, wherein the external teeth of at least some of the pinion gears are meshed with the internal teeth of the driver gear.
According to some embodiments, the adjustment handle 210 is releasably attached to the valve holder 202. For example, the valve holder may include a holder recess 208 (or a plurality or recesses) along the its exterior surface, and the adjustment handle 210 can include complementary handle clamps 224 configured to engage with the holder recess 208. It is to be understood that various releasable attachment mechanisms may be implemented instead of clamps 224 and recesses 208, such as threaded-engagements, snap-fit, frictional engagements, and the like.
An adjustment handle 210a can comprise a plurality of pinion gears, that include primary pinion gears 214a and secondary pinion gears 216a. The primary pinion gears 214a are meshed with the driver gear 212a, while the secondary pinion gears 216a are meshed with the primary pinion gears 214a, but not with the driver gear 212a. In this manner, when the driver gear 212a is rotated, it facilitates rotation of the primary pinion gears 214a in one direction, while the secondary pinion gears 216a are rotated by the primary pinion gears 214a in an opposite direction.
The driving rod 218a extending from a primary pinion gear 214a is configured to engage, via its driving head 220a, with one adjustable arm 162a of an adjustable commissure support 160, while the driving rod 218a extending from a secondary pinion gear 216a meshed with the same primary pinion gear 214a is configured to engage, via its driving head 220a, with the other adjustable arm 162b of the same adjustable commissure support 160. In this manner, when each primary pinion gear 214a and a secondary pinion gear 216a meshed therewith are rotated in opposite rotational directions, they rotate the engagement portions 166a and 166b of two adjustable arms 162 of each adjustable commissure support 160 in opposite rotational directions, which can facilitate twisting of both adjustable arms 162aa and 162ab, or rotation of both adjustable arms 162ba and 162bb, in opposite directions with respect to each other, as shown in
As mentioned above, both tabs 132a and 132b maybe wrapped around the adjustable arms 162a and 162b in the same direction, in some embodiments, instead of in opposite directions. In such embodiments, the commissure adjustment assembly 200 will be modified to include only primary pinion gears 214 which are meshed directly with the driver gear 212 but not with each other, and wherein the number of primary pinion gears 214 matches the number of adjustable arms 162. For example, if the prosthetic valve 100 includes three adjustable commissure supports 160, each having two adjustable arms 162 extending from its support base 172, the total number of primary pinion gears 214 can be six, including three couples of primary pinion gears 214 wherein each couple includes two pinion gears 214 that are spaced apart from each other such that the primary pinion gears 214 are not meshed with each other, and the driving rods 218 extending therefrom are spaced from each other by a gap G′, enabling their driving heads 220 to engage with the corresponding engagement portions 166. In this manner, rotation of the driver gear 212 will rotate all of the primary pinion gears 214 in the same direction, which will translate the rotational movement to the engagement portions 166 of all respective adjustable arms 162.
It is to be understood that any of the features described with respect to adjustable commissure supports 160a or 160b can be implemented in combination with the single adjustable arm 162c of the adjustable commissure support 160c. For example, the adjustable arm 162c can be formed as a twistable arm comprising a plastically deformable material, in a manner similar to that described for adjustable arms 162a with respect to
As shown in the zoomed-in region of
Conventional leaflets 126a, as shown in
According to some embodiments, the leaflet (126) is asymmetric with respect to the leaflet central axis 90, such that the lengths of the tabs on both sides of the leaflet are different.
According to some embodiments, the length of the long tab L2 is longer than the length of the short tab L1. According to some embodiments, L2 is at least as long as 110% of L1. According to some embodiments, L2 is at least as long as 120% of L1. According to some embodiments, L2 is at least as long as 150% of L1. According to some embodiments, L2 is at least as long as 200% of L1.
According to some embodiments, there is provided a method for assembling a commissure assembly (134), comprising steps of: (1) wrapping a tab (132a) of one leaflet (126a) over an adjustable arm 162c; (2) wrapping another tab of an adjacent leaflet (126b) over the previous tab; and (3) suturing both tabs to the adjustable arm 162c via a suture 176 extending through both tabs and apertures 164 of the adjustable arm 162c. In some embodiments, the step of suturing includes passing the suture 176 through portions of the tabs disposed over opposite sides of the adjustable arm 162c.
According to some embodiments, the step of wrapping a tab of one leaflet over the adjustable arm includes wrapping a short tab (132ba) of the one leaflet (126ba) over the adjustable arm 162c, and the step of wrapping another tab includes wrapping a long tab (132bb) of the adjacent leaflet (126ba) over the short tab (132ba).
The commissure adjustment assembly 200b includes the same valve holder 202 described hereinabove with respect to
The driving rod 218b extending from each primary pinion gear 214b is configured to engage, via its driving head 220b, with the single adjustable arm 162c of an adjustable commissure support 160c. Thus, when each primary pinion gears 214b are rotated by the driver gear 212b, they rotate the engagement portions 166c of the adjustable arms 162c therewith, which in turn facilitate twisting or rotation of the adjustable arms 162c.
According to some embodiments, there is provided a method for adjusting the tension of leaflets (126) of a prosthetic valve (100), comprising steps of: (1) placing a prosthetic valve (100) having a plurality of adjustable commissure supports (160) within a valve holder (202) of a commissure adjustment assembly (200); (2) releasably coupling an adjustment handle (210) to the valve holder (202), such that driving heads (220) of driving rods (218) extending from pinion gears, that are positioned within a driver gear, engage with engagement portions (166) of adjustable arms (162) of the adjustable commissure supports (160); and (3) rotating the driver gear (212) to facilitate rotation of the pinion gears rotatable thereby, which in turn rotate the engagement portions therewith.
According to some embodiments, the step of placing the prosthetic valve (100) within the valve holder (202), includes a step of expanding the prosthetic valve (100) against the annular holder body (206) of the valve holder (202).
According to some embodiments, each adjustable commissure support 160c includes a single adjustable arm 162c, and the pinion gears include primary pinion gears 214b meshed with the driver gear 212b. In such embodiments, the step of coupling includes engaging the driving heads 220b of driving rods 218b extending from the primary pinion gears 214b with the engagement portions 166c of the single adjustable arms 162c of the adjustable commissure supports 160c. Furthermore, in such embodiments, the step of rotating includes rotating the driver gear 212b to facilitate rotation of the primary pinion gears 214b meshed therewith.
According to some embodiments, each adjustable commissure support (160a, 160b) includes two adjustable arms (162b, 162c), and the pinion gears include primary pinion gears 214a meshed with the driver gear 212a, and secondary pinion gears 216a meshed with the primary pinion gears 214a but not with the driver gear 212a. In such embodiments, the step of coupling includes engaging the driving head 220a of the driving rod 218a extending from each primary pinion gear 214a with one adjustable arm (162ba, 162ca) of an adjustable commissure support (160a, 160b), and engaging the driving head 220a of the driving rod 218a extending from the secondary pinion gear 216a meshed with the with the primary pinion gear 214a, with the other adjustable arm (162bb, 162cb) of the same adjustable commissure support (160a, 160b). Furthermore, in such embodiments, the step of rotating includes rotating the driver gear 212a to facilitate rotation of the primary pinion gears 214a and the secondary pinion gears 216a in opposite rotational directions.
In some implementations of the current invention, adjustment of the leaflet assembly (124) mounted within the prosthetic valve (100) is performed during the implantation procedure. For example, adjustment of the leaflet assembly (124) can be facilitated by a delivery apparatus (12) coupled to the prosthetic valve (100) during the implantation procedure.
The driving heads 54 are shaped with complementary shapes to those of the engagement portions 166. For example, if the engagement portion 166 of each adjustable arm 162 comprises a socket 168, the driving head 54 is shaped as a non-cylindrical extension configured to be inserted into the socket 168, such that rotation of the driving head 54 will rotate the engagement portion 166 therewith. More specifically, if the socket 168 is shaped as a rectangular socket, as shown in
The driving heads 54 are releasably engaged with the engagement portions 166 of the adjustable arms. As shown in
The adjustment sleeve 56 can be coaxially disposed over the adjustment arms 52, including the driving head 54, and may serve to prevent spontaneous disengagement between the driving head 54 and the engagement portion 166. The adjustment sleeve 56 may be in contact with the proximal end of the adjustable arm 162, for example - having the distal end of the adjustment sleeve 56 pressed against the proximal end of the engagement portions 166, as shown if
According to some embodiments, the adjustment assembly 50a comprises two adjustment arms 52a, configured to engage with two adjustable arms 162 of an adjustable commissure support 160, as shown in
A prosthetic valve 100 can be delivered in a crimped state by the delivery apparatus 12b through the patient’s vasculature, and expended against the native anatomy when reaching the desired implantations site. The implantation procedure can be visualized via various imaging modalities, such as fluoroscopy, ultrasound and the like, that may provide an indication of the prosthetic valve’s expanded diameter once expansion is completed. At this stage, the adjustment assemblies 50 can be utilized to adjust the tension of the leaflet (126) mounted within the expanded valve, so as to allow proper coaptation thereof at the actual expanded diameter of the frame (106).
As shown in
In the exemplary illustration of
It is to be understood that in alternative configurations, wherein both tabs (132) are wrapped around the respective adjustable arms (162) in the same direction, the adjustment arms 52aa and 52ab will be rotated in the same rotational direction.
Once the adjustable arms 162 are rotated or twisted to the desired position, so as to provide the sufficient tension to the leaflets (126) at the actual expanded diameter of the frame (106), the adjustment assemblies 50a can disengage from the adjustable commissure supports 160, to allow retrieval of the delivery apparatus 12b.
According to some embodiments, disengagement of the adjustment assemblies 50a includes first pulling the adjustment sleeves 56a in a proximally oriented direction 2, away from the adjustable arms 162, as shown in
Once the adjustment assemblies 50a are disengaged, they can be further pulled away and retracted, with the rest of the delivery apparatus 12b, from the patient’s body, leaving the prosthetic valve (100) implanted in the patient.
While
The driving head 54b is configured to engage with the complementary-shaped engagement portion 166d in a “hand-shake” type of engagement, as shown in
Once rotation of the adjustment arms 52b (
While
According to some embodiments, there is provided a method for adjusting the tension of leaflets (126) of a prosthetic valve (100), comprising steps of: (1) expanding the prosthetic valve (100) that includes a plurality of adjustable commissure supports, to a final expanded diameter; (2) rotating adjustment arms (52) that extend from a handle (30b) of a delivery apparatus (12b), and are coupled via driving heads (54) thereof to engagement portions (166) of adjustable arms(162) of the adjustable commissure supports (160), to facilitate rotation of the engagement portions (166) therewith; and (3) disengaging the driving heads (54) from the engagement portions (166).
According to some embodiments, the step of disengaging the driving heads includes pulling the driving heads (54) proximally away from the engagement portions (166).
According to some embodiments, the step of disengaging the driving heads includes pulling adjustment sleeves (56) that are disposed over the adjustment arms (52) in a proximal direction 2, so as to expose the driving heads (54).
According to some embodiments, the step of disengaging the driving heads includes simultaneously pulling the adjustment arms (52) with adjustment sleeves (56) disposed thereover.
According to some embodiments, the step of rotating the adjustment arms includes rotating each couple of adjustment arms (52) engaged with two adjustable arms (162) that extend from a single support base (172), in opposite rotational directions.
It is to be understood that the series of steps disclosed hereinabove can be performed either in a patient’s body, during the process of prosthetic valve implantation, or prior to an actual implantation procedure, for example to test the performance of the equipment. Utilization of the method can be performed, for example, in an experimental setup, to test the amount of rotation required for each frame (106) expansion diameter, so as to achieve proper leaflets (126) coaptation.
When utilized during an implantation procedure, within a patient’s body, the method can further comprise a step of retrieving the delivery apparatus (12b) from the patient’s body.
In some embodiments, the offsetting extensions 178e, 178f can be integrally formed with the support base 172e, 172f. In some embodiments, the offsetting extensions 178e, 178f can be integrally formed with the adjustable arms 162e, 162f.
It is to be understood that features of adjustable commissure supports 160e, 160f which include offsetting extensions 178e, 178f, can be combined with any other features of any other type of adjustable commissure supports 160a, 160b, 160c, and/or 160d described hereinabove. For example, each of the adjustable commissure supports 160e, 160f is illustrated with two offsetting extensions, such as offsetting extension 178ea from which adjustable arm 162ea extends, and offsetting extension 178eb from which adjustable arm 162eb extends, or such as offsetting extension 178fa from which adjustable arm 162fa extends, and offsetting extension 178fb from which adjustable arm 162fb extends, each adjustable commissure supports 160e, 160f can also include a single offsetting extension 178e, 178f, from which a single adjustable arm 162, such as the single adjustable arm 162c illustrated in
The adjustable arms 162e, 162f can be either rigidly attached to the offsetting extensions 178e, 178f, to enable twisting thereof, such as illustrated for adjustable arms 162a in
The engagement portions 166e, 166f can comprise sockets 168e, 168f, as illustrated in
Prosthetic valves 100e, 100f equipped with adjustable commissure supports 160e, 160f can be used in combination with any type of a commissure adjustment assembly 200, in the same manner described hereinabove, or in combination with any type of a delivery apparatus 12b equipped with adjustment assemblies 50, in the same manner describes hereinabove, mutatis mutandis.
An adjustable commissure support 160g comprises two adjustable arms 162g which are rotatably coupled to a support base 172g. The support base 172g can include two eyelets 180 configured to rotatably couple with the adjustable arms 162g. The support base can be either integrally formed with the frame 106g, such as being integrally formed with a junction 114 thereof, meaning that the junction 114 can be formed, during the manufacturing process of the frame 106g, to be shaped as, and to serve as, the support base 172g, as illustrated in
The adjustable commissure support 160g further comprises scallop adjustment arms 182, wherein each scallop adjustment arm 182 extends continuously from a respective adjustable arm 162g, and may be coupled to the frame 106g via additional eyelets 180 extending from junctions 114 or struts 110 thereof.
According to some embodiments, each adjustable arm 162g and scallop adjustment arm 182 are integrally formed, meaning that they may be manufactured and provided as a single continuous component. According to other embodiments, the adjustable arm 162g and the scallop adjustment arm 182 are provided as two separate components which are rigidly attached to each other, for example - at the region of the support base 172g, such that when the adjustable arm 162g is rotated, the scallop adjustment arm 182 rotates therewith. According to some embodiments, the scallop adjustment arm 182 comprises a torque transmitting shaft.
According to some embodiments, the eyelets 180 are eyelets through which the adjustable arms 162g and/or the scallop adjustment arms 182 extend. According to some embodiments, the adjustable arms 162g are threadedly engaged with the eyelets 180. According to some embodiments, the scallop adjustment arms 182 are threadedly engaged with the eyelets 180. According to some embodiments, at least some of the eyelets 180 include internal threads, and the adjustable arms 162g and/or the scallop adjustment arm 182 include external threads at the region extending through threaded eyelets 180.
As shown in the zoomed-in regions of
The eyelets 180 extend radially inward from the support bases 172g, junctions 114 and/or struts 110, such that the adjustable arms 162g and the scallop adjustment arms 182 are positioned radially inward with respect to the frame 106g.
The adjustable arms 162g comprise engagement portions 166g that can be implemented according to any of the embodiments described for engagement portions 166 hereinabove, such as engagement portions 166g that include non-cylindrical socket 168g, or engagement portions 166g that are shaped as drive-screw couplers, similar to engagement portion 166d illustrated in
In some embodiments, the adjustable arms 162g comprise a plurality of apertures 164, implemented in the same manner described hereinabove for apertures 164 comprised within any other type of the adjustable arms 162.
As shown, the scallop adjustment arms 182 are coupled to the frame 106g in a manner that generally tracks the scallop line of the leaflet assembly 124g. The cusp edge 128 of each leaflet 126 can be attached to scallop adjustment arms 182 of two adjustable commissure supports 160g positioned on both sides of the leaflet 126.
In use, the adjustable arms 162g can be rotated in a similar manner to their rotation described throughout the current specification, wherein both adjustable arms 162g of each adjustable commissure supports 160g are necessarily rotated in opposite direction. It is to be noted that unlike other embodiments of other type of adjustable commissure supports 160, the adjustable arms 162g are configured only to rotate and not to twist, each adjustable commissure support 160g necessarily includes two adjustable arms 162g and not only one, and each couple of adjustable arms 162g of the same adjustable commissure support 160g are necessarily rotated in opposite direction with respect to each other, and not in the same direction.
When the adjustable arms 162g are rotated, the scallop adjustment arms 182 extending therefrom are rotated therewith, which in turn cause the portions of the cusp edges 128 attached thereto, to wrap around the respective scallop adjustment arms 182 in a similar manner. Thus, the adjustable commissure supports 160g enable leaflet tension adjustment not only vit the tabs 132 of the leaflets 126, which will shorten or elongate the free edges 130, but also via the cusp edges 128, thereby providing a solution that enables the tension of the leaflets 126 to be adjusted in a manner that is more uniform along various regions of the leaflets 126.
The cusp edges 128 that are attached to the scallop adjustment arms 182 can be sutured thereto, for example by sutures 176. While not illustrated, the scallop adjustment arms 182 can include, in some embodiments, a plurality of apertures 164, similar to the apertures 164 extending through the adjustable arms 162, such that sutures 176 can extend through portions of the cusp edges 128 and such apertures 164 in a similar manner to that described for suturing tabs 132 to adjustable arms 162 hereinabove. In some configurations, it is preferable not to include eyelets 180 through which the scallop adjustment arms 182 can extend, along regions of scallop edge attachment to the scallop adjustment arms 182, in order to avoid interference with the attachment between the cusp edges 128 and the scallop adjustment arms 182. In such cases, the scallop adjustment arms 182 can extends through eyelets 180 extending from the support base 172g, which may be positioned above (or proximal to) the region of attachment to the cusp edges 128, and another eyelet 180 extending inwardly from the frame 106g below (or distal to) the region of attachment to the cusp edges 128.
It is to be understood that the adjustable arms 162g of each adjustable commissure support 160g are spaced from each other, forming a gap G′ therebetween, which can be dimensioned to allow tabs having a thickness T′ to extend therethrough, and optionally accommodate several layers of the tabs 132, in the same manner described hereinabove with respect to the gap G′ of
In some implementations, the prosthetic valve 100g can be used in combination with a commissure adjustment assembly 200a that includes primary pinion gears 214a and secondary pinion gears 216a, in a similar manner to that described hereinabove with respect to
In the case of being used in combination with a mechanically expandable valve 100h, the delivery apparatus 12c can further comprise a plurality of actuation assemblies 40 extending from the handle 30c through the delivery shaft 22. The actuation assemblies 40 can generally include actuation members 42 (hidden from view in
The outer member 138a may further comprise a spring biased arm 146a, attached to or extending from one sidewall of the outer member 138a, and having a tooth or pawl at its opposite end, biased inwards toward the inner member 150 when disposed within the outer member’s lumen.
At least one of the inner or outer member 150 or 138, respectively, is axially movable relative to its counterpart. The expansion and locking assembly 136a in the illustrated embodiments, comprises a ratchet mechanism or a ratchet assembly, wherein the pawl of the spring biased arm 146a of the outer member 138a is configured to engage with the teeth 156 of the inner member 150. The pawl of the spring biased arm 146a can have a shape that is complementary to the shape of the ratcheting teeth 156, such that the pawl of the spring biased arm 146a allows a sliding movement of the inner member 150 in one direction relative to the outer member 138a, for example in a proximally oriented direction 2, and resists sliding movement of the inner member 150 in the opposite direction, such as a distally oriented direction, when the pawl of the spring biased arm 146a is in engagement with the ratcheting teeth 156 of the inner member 150.
The spring biased arm 146a can be formed of a flexible or resilient portion of the outer member 138a that extends over and contacts, via its pawl, an opposing side of the outer surface of the inner member 150. According to some embodiments, the spring biased arm 146a can be in the form of a leaf spring that can be integrally formed with the outer member 138a or separately formed and subsequently connected to the outer member 138a. The spring biased arm 146a is configured to apply a biasing force against the outer surface of the inner member 150, so as to ensure that under normal operation, its pawl stays engaged with the ratcheting teeth 156 of the inner member 150.
A mechanically expandable prosthetic valve 100h may be releasably attachable to at least one actuation assembly 40, and preferably a plurality of actuation assemblies 40, matching the number of expansion and locking assemblies 136. The actuation member 42 and the actuation support sleeve 46 can be movable longitudinally relative to each other in a telescoping manner to radially expand and contract the frame 106h, as further described in U.S. Publication Nos. 2018/0153689, 2018/0153689 and 2018/0325665 which are incorporated herein by reference. The actuation members 42 can be, for example, wires, cables, rods, or tubes. The actuation support sleeves 46 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 member proximal end portion 152 further comprises an inner member threaded bore 153, configured to receive and threadedly engage with a threaded portion of a distal end portion 44 (shown for example in
According to some embodiments, the actuation assemblies 40 are configured to releasably couple to the prosthetic valve 100h, and to move the prosthetic valve 100h between the radially compressed and the radially expanded configurations.
The expansion and locking assembly 136a is shown in
As further shown in
The actuation support sleeve 46 surrounds the actuation member 42 and may be connected to the handle 30c of a delivery apparatus 12c. The actuation support sleeve 46 and the outer member 138a are sized such that the distal lip of the actuation support sleeve 46 can abut or engage the outer member proximal end 140a, such that the outer member 138a is prevented from moving proximally beyond the actuation support sleeve 46.
In order to radially expand the frame 106h, and therefore the valve 100h, the actuation support sleeve 46 can be held firmly against the outer member 138a. The actuation member 42 can then be pulled in a proximally oriented direction 2, as shown in
More specifically, as shown for example in
The struts 110h to which the inner member fastening extension 158 is connected are free to pivot relative to the fastening extension 158 and to one another as the frame 106h is expanded or compressed. In this manner, the inner member fastening extension 158 serves as a fastener that forms a pivotable connection between those struts 110h. Similarly, struts 110h to which the outer member fastening extension 144a is connected are also free to pivot relative to the fastening extension 144a and to one another as the frame 106h is expanded or compressed. In this manner, the outer member fastening extension 144a also serves as a fastener that forms a pivotable connection between those struts 110h.
When the pawl of the spring biased arm 146a is engaged with the ratcheting teeth 156, the inner member 150 can move in one axial direction, such as the proximally oriented direction 2, but cannot move in the opposite axial direction. This ensures that while the pawl of the spring biased arm 146a is engaged with the he ratcheting teeth 156, the frame 106h can radially expand but cannot be radially compressed. Thus, after the prosthetic valve 100h is implanted in the patient, the frame 106h can be expanded to a desired diameter by pulling the actuation member 42. In this manner, the actuation mechanism also serves as a locking mechanism of the prosthetic valve 100h.
Once the desired diameter of the prosthetic valve 100h is reached, the actuation member 42 may be rotated, for example in rotation direction 8, to unscrew the actuation member 42 from the inner member 150, as shown in
Thus, the prosthetic valve 100h is radially expandable from the radially compressed state shown in
While the frame 106h is shown above to expand radially outward by axially moving the inner member 150 in a proximally oriented direction 2, relative to the outer member 138, it will be understood that similar frame expansion may be achieved by axially pushing an outer member 138 in a distally oriented direction, relative to an inner member 150.
While a threaded engagement is illustrated and described in the above embodiments, serving as an optional reversible-attachment mechanism between the actuation assemblies 40 and the inner members 150, it is to be understood that in alternative implementations, other reversible attachment mechanisms may be utilized, configured to enable the inner member 150 to be pulled or pushed by the actuation assemblies 40, while enabling disconnection there-between in any suitable manner, so as to allow retraction of the delivery apparatus from the patient’s body at the end of the implantation procedure.
While a specific actuation mechanism is described above, utilizing a ratcheting mechanism between the inner and the outer members of the expansion and locking assemblies 136, other mechanisms may be employed to promote relative movement between inner and outer members of actuation assemblies, for example via threaded or other engagement mechanisms. Further details regarding the structure and operation of mechanically expandable valves and delivery system thereof are described in US Patent No. 9,827,093, U.S. Pat. Application Publication Nos. 2019/0060057, 2018/0153689 and 2018/0344456, and U.S. Pat. Application Nos. 62/870,372 and 62/776,348, all of which are incorporated herein by reference.
According to some embodiments, a prosthetic valve 100h comprises at least one adjustable commissure support 160h provided with a clamp 184, coupled to the frame 106h, wherein at least one outer member 138 of an expansion and locking assembly 140 is configured to snap-fit or clip into the at least one clamp 184 of the adjustable commissure support 160h.
According to some embodiments, the clamp mid-portion 186 comprises an opening 190, configured to receive a fastener that may extend therethrough, such as an outer member fastening extension 144.
The gap G″ can be dimensioned to allow tabs having a thickness T′ to extend therethrough, and optionally accommodate several layers of the tabs 132, in the same manner described hereinabove with respect to the gap G′ of
The side arms 188 are resiliently expandable away from each other, such that the outer member coupling recess 148 is passable through the gap G″ formed between the adjustable arms 162h extending therefrom. In use, the outer member 138b may be pushed into the clamp 184, having the outer member coupling recess 148 aligned with the clamp 184. The gap G″ is smaller than the maximal lateral width W′ of the outer member 138b (width W′ may be measured at the region of the outer member coupling recess 148). The sidewalls of the outer member 138b, at the region of the recess 148, may apply a force sufficient to expand the side arms 188 away from each other, so as to allow the outer member 138b to pass therethrough radially outward, toward the clamp mid-portion 186. Once the outer member coupling recess 148 is completely accommodated within the clamp 184, and in the absence of further expanding force applied to the side arms 188, the side arms resiliently snap back toward each other to compress against the outer member coupling recess 148, in order to lock in place the outer member 138b with respect to the clamp 184.
In some implementations, the height H′ of the outer member coupling recess 148, is substantially equal to the height H″ of the clamp 184, such that when the outer member 138b is engaged with the clamp 184, axial movement between the outer member 138b and the adjustable commissure support 160h is prevented.
The term “substantially equal”, as used herein, means within a range of no more than ±10 percent of the referred measure. For example, the height H′ of the outer member coupling recess 148 being substantially equal to the height H″ of the clamp 184, means that height H′ is not greater than 110% of the height H″.
In some implementations, the depth R′ of the outer member coupling recess 148 is substantially equal to the thickness T′ of the clamp 184, such that when the clamp 184 is engaged with the outer member 138b, the clamp’s outer surface is flush with the outer surface of the outer member (138b) around the recess 148.
It is to be understood that features of adjustable commissure supports 160h that include adjustable arm 162h extending from side arms 188 of a clamp 184 can be combined with any other features of any other type of adjustable commissure supports 160a, 160b, 160c, and/or 160d described hereinabove, and include two adjustable arm 162 for each adjustable commissure supports 160. For example, the engagement portions 166h can comprise sockets 168h as illustrated in
In some implementations, the adjustable commissure supports 160h, 160i can be used in combination with a commissure adjustment assembly 200a that includes primary pinion gears 214a and secondary pinion gears 216a, in a similar manner to that described hereinabove with respect to
Reference is made to
In such embodiments, the outer member (138) will be devoid of an outer member fastening extension (144). The adjustable commissure supports (160) will be attached to the frame (106) by insertion of the commissure support fastening extension (192) into apertures formed within a junction (114) of the frame (106), similar to the attachment configuration shown in
The adjustable arms 162m comprise, as illustrated throughout
The driving heads 54b of the adjustment arms 52b are releasably engaged with the engagement portions 166m of the adjustable arms 162m, while the adjustment sleeves 56m cover, in the illustrated configuration, both the driving heads 54b and the engagement portions 166m, so as to prevent spontaneous disengagement therebetween.
While the outer member 138b is illustrated in
The expansion and locking assembly 136b is shown in
The actuation support sleeve 46 surrounds the actuation member 42 and may be connected to the handle 30d of a delivery apparatus 12d. In order to radially expand the frame 106h, and therefore the valve 100h, the actuation support sleeve 46 can be held firmly against the outer member 138b. The actuation member 42 can then be pulled in a proximally oriented direction 2. Because the actuation support sleeve 46 is being held against the outer member 138b, which is connected to the frame 106h at the first location, the outflow end 102 of the frame 106h is prevented from moving relative to the actuation support sleeve 46. As such, movement of the actuation member 42 in a proximally oriented direction 2 can cause movement of the inner member 150 in the same direction, thereby causing the frame 106h to foreshorten axially and expand radially.
Once the desired diameter of the prosthetic valve 100h is reached, the actuation member 42 may be rotated, to unscrew the actuation member 42 from the inner member 150. This rotation serves to disengage the distal threaded portion 44 of the actuation member 42 from the inner member threaded bore 153, enabling the actuation assemblies 40 to be pulled away, and retracted, as shown in
At this stage, the actual expansion diameter of the frame 106h can be determined or estimated, based on various typed of expansion diameter indications method, including, but not limited to, imaging modalities such as fluoroscopy or ultrasound. Once a determination is made regarding the actual expansion diameter of the frame 106h, the clinician may decide whether leaflets tension should be adjusted according to this diameter. If adjustment is required, the adjustment assemblies 50b can be utilized to adjust the tension of the leaflet (126) mounted within the expanded valve, so as to allow proper coaptation thereof.
In the exemplary illustration of
It is to be understood that in alternative configurations, wherein both tabs (132) are wrapped around the respective adjustable arms (162m) in the same direction, the adjustment arms 52ba and 52bb will be rotated in the same rotational direction.
Once rotation of the adjustment arms 52b is completed, the adjustment sleeves 56b are pulled proximally 2, as shown in
While adjustment of the adjustable commissure support 160m is illustrated in
In view of the above described implementations of the disclosed subject matter, this application discloses the additional examples enumerated below. It should be noted that one feature of an example in isolation or more than one feature of the example taken in combination and, optionally, in combination with one or more features of one or more further examples are further examples also falling within the disclosure of this application.
Example 1. A prosthetic valve, comprising:
Example 2. The prosthetic valve of any example herein, particularly example 1, wherein the support base is integrally formed with the frame.
Example 3. The prosthetic valve of any example herein, particularly any one of examples 1 to 2, wherein the tabs are wrapped over the adjustable arms.
Example 4. The prosthetic valve of any example herein, particularly any one of examples 1 to 3, wherein each adjustable arm has a non-circular cross section.
Example 5. The prosthetic valve of any example herein, particularly any one of examples 1 to 4, wherein each adjustable arm comprises a plurality of apertures.
Example 6. The prosthetic valve of any example herein, particularly example 5, wherein the apertures are axially spaced apart from each other.
Example 7. The prosthetic valve of any example herein, particularly any one of examples 5 to 6, wherein the tabs are sutured to the adjustable arms via sutures through the tabs and the apertures.
Example 8. The prosthetic valve of any example herein, particularly example 7, wherein the sutures extend through portions of the tab disposed over opposite sides of the adjustment arms.
Example 9. The prosthetic valve of any example herein, particularly any one of examples 1 to 8, wherein the engagement portion comprises a non-cylindrical socket.
Example 10. The prosthetic valve of any example herein, particularly any one of examples 1 to 8, wherein the engagement portion comprises a proximally oriented extension formed as a drive-screw coupler.
Example 11. The prosthetic valve of any example herein, particularly example 10, wherein the engagement portion comprises an angled surface.
Example 12. The prosthetic valve of any example herein, particularly any one of examples 1 to 1, wherein the adjustable arms are rigidly attached to the support base.
Example 13. The prosthetic valve of any example herein, particularly any one of examples 1 to 1, wherein the adjustable arms are integrally formed with the support base.
Example 14. The prosthetic valve of any example herein, particularly any one of examples 12 to 13, wherein the adjustable arms are configured to twist between the support base and the engagement portions, upon application of rotational force to the engagement portions.
Example 15. The prosthetic valve of any example herein, particularly example 14, wherein the adjustable arms comprise a plastically deformable material.
Example 16. The prosthetic valve of any example herein, particularly any one of examples 1 to 11, wherein the adjustable arms are rotationally coupled to the support base.
Example 17. The prosthetic valve of any example herein, particularly example 16, wherein the adjustable arms are threadedly coupled to the support base.
Example 18. The prosthetic valve of any example herein, particularly example 17, wherein the support base comprises at least one base threaded portion, and wherein each adjustable arm comprises an adjustable arm threaded portion, configured to threadedly engage with the base threaded portion.
Example 19. The prosthetic valve of any example herein, particularly any one of examples 1 to 18, wherein the support base further comprises at least one offsetting extension, extending radially therefrom, and wherein the at least one adjustable arm extends from the respective offsetting extension.
Example 20. The prosthetic valve of any example herein, particularly example 19, wherein the at least one offsetting extension extends radially away from the support base.
Example 21. The prosthetic valve of any example herein, particularly example 19, wherein the at least one offsetting extension extends radially inward with respect to the support base.
Example 22. The prosthetic valve of any example herein, particularly any one of examples 19 to 21, wherein the offsetting extension is integrally formed with the support base.
Example 23. The prosthetic valve of any example herein, particularly any one of examples 1 to 18, wherein each adjustable commissure support further comprises a commissure support fastening extension.
Example 24. The prosthetic valve of any example herein, particularly example 23, wherein the adjustable commissure supports are attached to the frame via the commissure support fastening extensions, such that the adjustable arms are positioned radially inward with respect to the frame.
Example 25. The prosthetic valve of any example herein, particularly any one of examples 1 to 24, wherein each adjustable commissure support comprises a single adjustable arm.
Example 26. The prosthetic valve of any example herein, particularly example 25, wherein two tabs of adjacent leaflets of the leaflet assembly are attached to the adjustable commissure support, such that both tabs are wrapped over the single adjustable arm.
Example 27. The prosthetic valve of any example herein, particularly example 26, wherein the leaflets are asymmetric leaflets, each asymmetric leaflet having a short tab and an opposite long tab, and wherein the tabs of adjacent leaflets are wrapped over the single adjustable arm such that the short tab of one leaflet is wrapped around the adjustable arm, in direct contact therewith, and the long tab of the adjacent leaflet is wrapped over the short tab.
Example 28. The prosthetic valve of any example herein, particularly example 27, wherein the length of the long tab is at least 10% longer than the length of the short tab.
Example 29. The prosthetic valve of any example herein, particularly example 27, wherein the length of the long tab is at least 20% longer than the length of the short tab.
Example 30. The prosthetic valve of any example herein, particularly example 27, wherein the length of the long tab is at least 50% longer than the length of the short tab.
Example 31. The prosthetic valve of any example herein, particularly example 27, wherein the length of the long tab is at least 100% longer than the length of the short tab.
Example 32. The prosthetic valve of any example herein, particularly any one of examples 1 to 24, wherein each adjustable commissure support comprises two adjustable arms that are laterally spaced from each other and define a gap therebetween.
Example 33. The prosthetic valve of any example herein, particularly example 32, wherein two tabs of adjacent leaflets of the leaflet assembly are attached to the adjustable commissure support, such that each tab is wrapped over one of the adjustable arms.
Example 34. The prosthetic valve of any example herein, particularly example 33, wherein both tabs are wrapped over the respective adjustable arms in opposite directions with respect to each other.
Example 35. The prosthetic valve of any example herein, particularly any one of examples 32 to 34, wherein the gap is at least two times larger than the thickness of the tabs.
Example 36. The prosthetic valve of any example herein, particularly any one of examples 32 to 34, wherein the gap is at least four times larger than the thickness of the tabs.
Example 37. The prosthetic valve of any example herein, particularly any one of examples 32 to 34, wherein the gap is at least six times larger than the thickness of the tabs.
Example 38. The prosthetic valve of any example herein, particularly any one of examples 32 to 34, wherein the gap is at least eight times larger than the thickness of the tabs.
Example 39. A prosthetic valve comprising:
Example 40. The prosthetic valve of any example herein, particularly example 39, wherein the support base is integrally formed with the frame.
Example 41. The prosthetic valve of any example herein, particularly any one of examples 39 to 40, wherein each adjustable arm and the scallop adjustment arm extending therefrom are integrally formed.
Example 42. The prosthetic valve of any example herein, particularly any one of examples 39 to 41, wherein the scallop adjustment arm comprises a torque transmitting shaft.
Example 43. The prosthetic valve of any example herein, particularly any one of examples 39 to 42, wherein the support base comprises two eyelets through which the adjustable arms and/or the scallop adjustment arms extend.
Example 44. The prosthetic valve of any example herein, particularly any one of examples 39 to 42, wherein the frame comprises eyelets through which the scallop adjustment arms extend.
Example 45. The prosthetic valve of any example herein, particularly any one of examples 43 to 44, wherein the eyelets are extending radially inward.
Example 46. The prosthetic valve of any example herein, particularly any one of examples 43 to 45, wherein the eyelets comprises internal threads.
Example 47. The prosthetic valve of any example herein, particularly any one of examples 39 to 46, wherein the tabs are wrapped over the adjustable arms.
Example 48. The prosthetic valve of any example herein, particularly any one of examples 39 to 47, wherein each adjustable arm comprises a plurality of apertures.
Example 49. The prosthetic valve of any example herein, particularly example 48, wherein the apertures are axially spaced apart from each other.
Example 50. The prosthetic valve of any example herein, particularly any one of examples 48 to 49, wherein the tabs are sutured to the adjustable arms via sutures through the tabs and the apertures.
Example 51. The prosthetic valve of any example herein, particularly example 50, wherein the sutures extend through portions of the tab disposed over opposite sides of the adjustment arms.
Example 52. The prosthetic valve of any example herein, particularly any one of examples 39 to 46, wherein portions of the cusp edges are wrapped over the scallop adjustment arms.
Example 53. The prosthetic valve of any example herein, particularly example 52, wherein each scallop adjustment arm comprises a plurality of apertures.
Example 54. The prosthetic valve of any example herein, particularly example 53, wherein the apertures are axially spaced apart from each other.
Example 55. The prosthetic valve of any example herein, particularly any one of examples 53 to 54, wherein the tabs are sutured to the scallop adjustment arms via sutures through the portions of the cusp edges and the apertures.
Example 56. The prosthetic valve of any example herein, particularly example 55, wherein the sutures extend through portions of the cusp edge disposed over opposite sides of the scallop adjustment arms.
Example 57. The prosthetic valve of any example herein, particularly any one of examples 39 to 56, wherein each engagement portion comprises a non-cylindrical socket.
Example 58. The prosthetic valve of any example herein, particularly any one of examples 39 to 56, wherein each engagement portion comprises a proximally oriented extension formed as a drive-screw coupler.
Example 59. The prosthetic valve of any example herein, particularly example 58, wherein each engagement portion comprises an angled surface.
Example 60. The prosthetic valve of any example herein, particularly any one of examples 39 to 59, wherein both adjustable arms of a single adjustable commissural support are laterally spaced from each other and define a gap therebetween.
Example 61. The prosthetic valve of any example herein, particularly example 60, wherein two tabs of adjacent leaflets of the leaflet assembly are attached to the adjustable commissure support, such that each tab is wrapped over one of the adjustable arms.
Example 62. The prosthetic valve of any example herein, particularly example 61, wherein both tabs are wrapped over the respective adjustable arms in opposite directions with respect to each other.
Example 63. The prosthetic valve of any example herein, particularly any one of examples 60 to 62, wherein the gap is at least two times larger than the thickness of the tabs.
Example 64. The prosthetic valve of any example herein, particularly any one of examples 60 to 62, wherein the gap is at least four times larger than the thickness of the tabs.
Example 65. The prosthetic valve of any example herein, particularly any one of examples 60 to 62, wherein the gap is at least six times larger than the thickness of the tabs.
Example 66. The prosthetic valve of any example herein, particularly any one of examples 60 to 62, wherein the gap is at least eight times larger than the thickness of the tabs.
Example 67. A prosthetic valve comprising:
Example 68. The prosthetic valve of any example herein, particularly example 67, wherein the clamp mid-portion comprises an opening, and wherein the outer member comprises an outer member fastening extension extending radially outward through the opening, and coupled to the frame at the first location.
Example 69. The prosthetic valve of any example herein, particularly example 67, wherein the clamp mid-portion comprises a commissure support fastening extension, extending radially outward from the clamp mid-portion, and coupled to the frame at the first location.
Example 70. The prosthetic valve of any example herein, particularly any one of examples 67 to 69, wherein the outer member coupling recess has a depth which is equal to, or greater than, the thickness of the clamp.
Example 71. The prosthetic valve of any example herein, particularly any one of examples 67 to 70, wherein the outer member coupling recess has a height which is not greater than 110% of the height of the clamp.
Example 72. The prosthetic valve of any example herein, particularly any one of examples 67 to 71, wherein the tabs are wrapped over the adjustable arms.
Example 73. The prosthetic valve of any example herein, particularly any one of examples 67 to 72, wherein each adjustable arm has a non-circular cross section.
Example 74. The prosthetic valve of any example herein, particularly any one of examples 67 to 73, wherein each adjustable arm comprises a plurality of apertures.
Example 75. The prosthetic valve of any example herein, particularly example 74, wherein the apertures are axially spaced apart from each other.
Example 76. The prosthetic valve of any example herein, particularly any one of examples 74 to 75, wherein the tabs are sutured to the adjustable arms via sutures through the tabs and the apertures.
Example 77. The prosthetic valve of any example herein, particularly example 76, wherein the sutures extend through portions of the tab disposed over opposite sides of the adjustment arms.
Example 78. The prosthetic valve of any example herein, particularly any one of examples 67 to 77, wherein the engagement portion comprises a non-cylindrical socket.
Example 79. The prosthetic valve of any example herein, particularly any one of examples 67 to 77, wherein the engagement portion comprises a proximally oriented extension formed as a drive-screw coupler.
Example 80. The prosthetic valve of any example herein, particularly example 79, wherein the engagement portion comprises an angled surface.
Example 81. The prosthetic valve of any example herein, particularly any one of examples 67 to 80, wherein the adjustable arms are rigidly attached to the side arms.
Example 82. The prosthetic valve of any example herein, particularly any one of examples 67 to 80, wherein the adjustable arms are integrally formed with the side arms.
Example 83. The prosthetic valve of any example herein, particularly any one of examples 81 to 82, wherein the adjustable arms are configured to twist between the side arms and the engagement portions, upon application of rotational force to the engagement portions.
Example 84. The prosthetic valve of any example herein, particularly example 83, wherein the adjustable arms comprise a plastically deformable material.
Example 85. The prosthetic valve of any example herein, particularly any one of examples 67 to 70, wherein the adjustable arms are rotationally coupled to the side arms.
Example 86. The prosthetic valve of any example herein, particularly example 85, wherein the adjustable arms are threadedly coupled to the side arms.
Example 87. The prosthetic valve of any example herein, particularly example 86, wherein each side arm comprises a base threaded portion, and wherein each adjustable arm comprises an adjustable arm threaded portion, configured to threadedly engage with the base threaded portion.
Example 88. The prosthetic valve of any example herein, particularly any one of examples 67 to 87, wherein both adjustable arms of a single adjustable commissural support are laterally spaced from each other and define a gap therebetween.
Example 89. The prosthetic valve of any example herein, particularly example 88, wherein two tabs of adjacent leaflets of the leaflet assembly are attached to the adjustable commissure support, such that each tab is wrapped over one of the adjustable arms.
Example 90. The prosthetic valve of any example herein, particularly example 89, wherein both tabs are wrapped over the respective adjustable arms in opposite directions with respect to each other.
Example 91. The prosthetic valve of any example herein, particularly any one of examples 88 to 90, wherein the gap is at least two times larger than the thickness of the tabs.
Example 92. The prosthetic valve of any example herein, particularly any one of examples 88 to 90, wherein the gap is at least four times larger than the thickness of the tabs.
Example 93. The prosthetic valve of any example herein, particularly any one of examples 88 to 90, wherein the gap is at least six times larger than the thickness of the tabs.
Example 94. The prosthetic valve of any example herein, particularly any one of examples 88 to 90, wherein the gap is at least eight times larger than the thickness of the tabs.
Example 95. The prosthetic valve of any example herein, particularly any one of examples 88 to 90, wherein the gap, at a free state of the side arms, is smaller than a width of the outer member at the region of the outer member coupling recess.
Example 96. The prosthetic valve of any example herein, particularly any one of examples 67 to 95, wherein the adjustable arms are offset radially inward with respect to the outer member, defining an offsetting gap therebetween.
Example 97. The prosthetic valve of any example herein, particularly example 96, wherein the offsetting gap is larger than the thickness of the tab.
Example 98. The prosthetic valve of any example herein, particularly example 96, wherein the offsetting gap is at least two times larger than the thickness of the tab.
Example 99. The prosthetic valve of any example herein, particularly example 96, wherein the offsetting gap is at least three times larger than the thickness of the tab.
Example 100. The prosthetic valve of any example herein, particularly example 96, wherein the offsetting gap is at least four times larger than the thickness of the tab.
Example 101. A delivery assembly, comprising:
Example 102. The delivery assembly of any example herein, particularly example 101, wherein the adjustment arm is a torque transmitting arm, configured to transmit torque from the handle to the engagement portion.
Example 103. The delivery assembly of any example herein, particularly any one of examples 101 to 102, wherein each adjustment assembly further comprises an adjustment sleeve extending over the adjustment arm.
Example 104. The delivery assembly of any example herein, particularly example 103, wherein the adjustment sleeve and the adjustment arms are movable longitudinally relative to each other.
Example 105. The delivery assembly of any example herein, particularly any one of examples 101 to 104, wherein the tabs are wrapped over the adjustable arms.
Example 106. The delivery assembly of any example herein, particularly any one of examples 101 to 105, wherein each adjustable arm has a non-circular cross section.
Example 107. The delivery assembly of any example herein, particularly any one of examples 101 to 106, wherein each adjustable arm comprises a plurality of apertures.
Example 108. The delivery assembly of any example herein, particularly example 107, wherein the apertures are axially spaced apart from each other.
Example 109. The delivery assembly of any example herein, particularly any one of examples 106 to 107, wherein the tabs are sutured to the adjustable arms via sutures through the tabs and the apertures.
Example 110. The delivery assembly of any example herein, particularly example 109, wherein the sutures extend through portions of the tab disposed over opposite sides of the adjustment arms.
Example 111. The delivery assembly of any example herein, particularly any one of examples 101 to 110, wherein the engagement portion comprises a non-cylindrical socket.
Example 112. The delivery assembly of any example herein, particularly example 111, wherein the driving head comprises a distally oriented non-circular extension, dimensioned to be inserted into the socket.
Example 113. The delivery assembly of any example herein, particularly any one of examples 101 to 110, wherein the engagement portion comprises a proximally oriented extension formed as a drive-screw coupler.
Example 114. The delivery assembly of any example herein, particularly example 113, wherein the engagement portion comprises an angled surface.
Example 115. The delivery assembly of any example herein, particularly any one of examples 113 to 114, wherein the driving head comprises a distally oriented extension formed as a drive-screw coupler, complementary to the drive-screw coupler shape of the engagement portion.
Example 116. The delivery assembly of any example herein, particularly any one of examples 101 to 115, wherein the adjustable arms are rigidly attached to the support base.
Example 117. The delivery assembly of any example herein, particularly any one of examples 101 to 115, wherein the adjustable arms are integrally formed with the support base.
Example 118. The delivery assembly of any example herein, particularly any one of examples 116 to 117, wherein the adjustable arms are configured to twist between the support base and the engagement portions, upon application of rotational force to the engagement portions.
Example 119. The delivery assembly of any example herein, particularly example 118, wherein the adjustable arms comprise a plastically deformable material.
Example 120. The delivery assembly of any example herein, particularly any one of examples 101 to 115, wherein the adjustable arms are rotationally coupled to the support base.
Example 121. The delivery assembly of any example herein, particularly example 120, wherein the adjustable arms are threadedly coupled to the support base.
Example 122. The delivery assembly of any example herein, particularly example 121, wherein the support base comprises at least one base threaded portion, and wherein each adjustable arm comprises an adjustable arm threaded portion, configured to threadedly engage with the base threaded portion.
Example 123. The delivery assembly of any example herein, particularly any one of examples 101 to 122, wherein the support base further comprises at least one offsetting extension, extending radially therefrom, and wherein the at least one adjustable arm extends from the respective offsetting extension.
Example 124. The delivery assembly of any example herein, particularly example 123, wherein the at least one offsetting extension extends radially away from the support base.
Example 125. The delivery assembly of any example herein, particularly example 123, wherein the at least one offsetting extension extends radially inward with respect to the support base.
Example 126. The delivery assembly of any example herein, particularly any one of examples 123 to 125, wherein the offsetting extension is integrally formed with the support base.
Example 127. The delivery assembly of any example herein, particularly any one of examples 101 to 126, wherein each adjustable commissure support comprises a single adjustable arm.
Example 128. The delivery assembly of any example herein, particularly example 123, wherein two tabs of adjacent leaflets of the leaflet assembly are attached to the adjustable commissure support, such that both tabs are wrapped over the single adjustable arm.
Example 129. The delivery assembly of any example herein, particularly example 128, wherein the leaflets are asymmetric leaflets, each asymmetric leaflet having a short tab and an opposite long tab, and wherein the tabs of adjacent leaflets are wrapped over the single adjustable arm such that the short tab of one leaflet is wrapped around the adjustable arm, in direct contact therewith, and the long tab of the adjacent leaflet is wrapped over the short tab.
Example 130. The delivery assembly of any example herein, particularly any one of examples 123 to 129, wherein each adjustment assembly comprises a single adjustment arm.
Example 131. The delivery assembly of any example herein, particularly any one of examples 101 to 126, wherein each adjustable commissure support comprises two adjustable arms that are laterally spaced from each other and define a gap therebetween.
Example 132. The delivery assembly of any example herein, particularly example 131, wherein two tabs of adjacent leaflets of the leaflet assembly are attached to the adjustable commissure support, such that each tab is wrapped over one of the adjustable arms.
Example 133. The delivery assembly of any example herein, particularly example 132, wherein both tabs are wrapped over the respective adjustable arms in opposite directions with respect to each other.
Example 134. The delivery assembly of any example herein, particularly any one of examples 131 to 133, wherein each adjustment assembly comprises two adjustment arms.
Example 135. A delivery assembly, comprising:
Example 136. The delivery assembly of any example herein, particularly example 135, wherein the clamp mid-portion comprises an opening, and wherein the outer member comprises an outer member fastening extension extending radially outward through the opening, and coupled to the frame at the first location.
Example 137. The delivery assembly of any example herein, particularly example 135, wherein the clamp mid-portion comprises a commissure support fastening extension, extending radially outward from the clamp mid-portion, and coupled to the frame at the first location.
Example 138. The delivery assembly of any example herein, particularly any one of examples 135 to 137, wherein the outer member coupling recess has a depth which is equal to, or greater than, the thickness of the clamp.
Example 139. The delivery assembly of any example herein, particularly any one of examples 135 to 138, wherein the outer member coupling recess has a height which is not greater than 110% of the height of the clamp.
Example 140. The delivery assembly of any example herein, particularly any one of examples 135 to 139, wherein the tabs are wrapped over the adjustable arms.
Example 141. The delivery assembly of any example herein, particularly any one of examples 135 to 140, wherein each adjustable arm has a non-circular cross section.
Example 142. The delivery assembly of any example herein, particularly any one of examples 135 to 141, wherein each adjustable arm comprises a plurality of apertures.
Example 143. The delivery assembly of any example herein, particularly example 142, wherein the apertures are axially spaced apart from each other.
Example 144. The delivery assembly of any example herein, particularly any one of examples 142 to 143, wherein the tabs are sutured to the adjustable arms via sutures through the tabs and the apertures.
Example 145. The delivery assembly of any example herein, particularly example 144, wherein the sutures extend through portions of the tab disposed over opposite sides of the adjustment arms.
Example 146. The delivery assembly of any example herein, particularly any one of examples 135 to 145, wherein the engagement portion comprises a non-cylindrical socket.
Example 147. The delivery assembly of any example herein, particularly example 146, wherein the driving head comprises a distally oriented non-circular extension, dimensioned to be inserted into the socket.
Example 148. The delivery assembly of any example herein, particularly any one of examples 135 to 145, wherein the engagement portion comprises a proximally oriented extension formed as a drive-screw coupler.
Example 149. The delivery assembly of any example herein, particularly example 148, wherein the engagement portion comprises an angled surface.
Example 150. The delivery assembly of any example herein, particularly any one of examples 148 to 149, wherein the driving head comprises a distally oriented extension formed as a drive-screw coupler, complementary to the drive-screw coupler shape of the engagement portion.
Example 151. The delivery assembly of any example herein, particularly any one of examples 135 to 150, wherein the adjustable arms are rigidly attached to the side arms.
Example 152. The delivery assembly of any example herein, particularly any one of examples 135 to 150, wherein the adjustable arms are integrally formed with the side arms.
Example 153. The delivery assembly of any example herein, particularly any one of examples 151 to 152, wherein the adjustable arms are configured to twist between the side arms and the engagement portions, upon application of rotational force to the engagement portions.
Example 154. The delivery assembly of any example herein, particularly example 153, wherein the adjustable arms comprise a plastically deformable material.
Example 155. The delivery assembly of any example herein, particularly any one of examples 135 to 150, wherein the adjustable arms are rotationally coupled to the side arms.
Example 156. The delivery assembly of any example herein, particularly example 155, wherein the adjustable arms are threadedly coupled to the side arms.
Example 157. The delivery assembly of any example herein, particularly example 156, wherein each side arm comprises a base threaded portion, and wherein each adjustable arm comprises an adjustable arm threaded portion, configured to threadedly engage with the base threaded portion.
Example 158. The delivery assembly of any example herein, particularly any one of examples 135 to 157, wherein both adjustable arms of a single adjustable commissural support are laterally spaced from each other and define a gap therebetween.
Example 159. The delivery assembly of any example herein, particularly example 158, wherein two tabs of adjacent leaflets of the leaflet assembly are attached to the adjustable commissure support, such that each tab is wrapped over one of the adjustable arms.
Example 160. The delivery assembly of any example herein, particularly example 159, wherein both tabs are wrapped over the respective adjustable arms in opposite directions with respect to each other.
Example 161. The delivery assembly of any example herein, particularly any one of examples 158 to 160, wherein the gap is at least two times larger than the thickness of the tabs.
Example 162. The delivery assembly of any example herein, particularly any one of examples 158 to 160, wherein the gap is at least four times larger than the thickness of the tabs.
Example 163. The delivery assembly of any example herein, particularly any one of examples 158 to 160, wherein the gap is at least six times larger than the thickness of the tabs.
Example 164. The delivery assembly of any example herein, particularly any one of examples 158 to 160, wherein the gap is at least eight times larger than the thickness of the tabs.
Example 165. The delivery assembly of any example herein, particularly any one of examples 158 to 160, wherein the gap, at a free state of the side arms, is smaller than a width of the outer member at the region of the outer member coupling recess.
Example 166. The delivery assembly of any example herein, particularly any one of examples 135 to 165, wherein the adjustable arms are offset radially inward with respect to the outer member, defining an offsetting gap therebetween.
Example 167. The delivery assembly of any example herein, particularly example 166, wherein the offsetting gap is larger than the thickness of the tab.
Example 168. The delivery assembly of any example herein, particularly example 166, wherein the offsetting gap is at least two times larger than the thickness of the tab.
Example 169. The delivery assembly of any example herein, particularly example 166, wherein the offsetting gap is at least three times larger than the thickness of the tab.
Example 170. The delivery assembly of any example herein, particularly example 166, wherein the offsetting gap is at least four times larger than the thickness of the tab.
Example 171. The delivery assembly of any example herein, particularly any one of examples 135 to 170, wherein the adjustment arm is a torque transmitting arm, configured to transmit torque from the handle to the engagement portion.
Example 172. The delivery assembly of any example herein, particularly any one of examples 135 to 171, wherein each adjustment assembly further comprises an adjustment sleeve extending over the adjustment arm.
Example 173. The delivery assembly of any example herein, particularly example 172, wherein
Example 174. A commissure adjustment assembly, comprising:
Example 175. The commissure adjustment assembly of any example herein, particularly example 174, wherein the valve holder comprises at least one recess, and wherein the adjustment handle comprises at least one clamp configured to engage with the at least one recess.
Example 176. The commissure adjustment assembly of any example herein, particularly any one of examples 174 to 175, wherein the adjustment handle further comprises a handle knob, configured to facilitate rotation of the driver gear.
Example 177. The commissure adjustment assembly of any example herein, particularly example 176, wherein the handle knob and the driver gear are integrally formed.
Example 178. The commissure adjustment assembly of any example herein, particularly any one of examples 174 to 177, wherein the driver gear is an internal gear having internal teeth, and wherein the pinion gears are external gears having external teeth, such that the teeth of at least some of the pinion gears are meshed with the teeth of the driver gear.
Example 179. The commissure adjustment assembly of any example herein, particularly any one of examples 174 to 178, wherein the pinion gears comprise primary pinion gears meshed with the driver gear.
Example 180. The commissure adjustment assembly of any example herein, particularly example 179, further comprising the prosthetic valve positioned within the valve holder, wherein the prosthetic valve comprises a plurality of adjustable commissure supports, wherein each adjustable commissure support comprises a single adjustable arm having the engagement portion, and wherein the driving head of each driving rod extending from a primary pinion gear is engaged with a corresponding engagement portion.
Example 181. The commissure adjustment assembly of any example herein, particularly example 179, further comprising the prosthetic valve positioned within the valve holder, wherein the prosthetic valve comprises a plurality of adjustable commissure supports, wherein each adjustable commissure support comprises two adjustable arm having engagement portions, wherein the driving head of each driving rod extending from a primary pinion gear is engaged with an engagement portion of one adjustable arm of an adjustable engagement support, and wherein each two of the plurality of primary pinion gears having their driving rods engaged with two adjustable arms of the same adjustable commissure supports, are not meshed with each other, and are having their driving rods spaced apart from each other by a gap that is equal to the gap between the respective engagement arms they are engaged with.
Example 182. The commissure adjustment assembly of any example herein, particularly example 179, wherein the pinion gears further comprise secondary pinion gears, which are meshed with the primary pinion gears, but not with the secondary pinion gears.
Example 183. The commissure adjustment assembly of any example herein, particularly example 182, further comprising the prosthetic valve positioned within the valve holder, wherein the prosthetic valve comprises a plurality of adjustable commissure supports, wherein each adjustable commissure support comprises two adjustable arm having engagement portions, and wherein the driving head of each driving rod extending from a primary pinion gear is engaged with an engagement portion of one adjustable arm of an adjustable engagement support, and wherein the driving head of each driving rod extending from the secondary pinion gear meshed with the primary pinion gear is engaged with an engagement portion of the other adjustable arm of the same adjustable engagement support.
Example 184. A method of assembling a commissure assembly, comprising:
Example 185. The method of any example herein, particularly example 184, wherein the step of suturing comprises passing the suture through portions of the tabs disposed over opposite sides of the adjustment arm.
Example 186. The method of any example herein, particularly any one of examples 184 to 185, wherein the step of wrapping a tab of one leaflet over the adjustable arm comprises wrapping a short tab of the one leaflet over the adjustable arm, and wherein the step of wrapping another tab includes wrapping a long tab of the adjacent leaflet over the short tab.
Example 187. A method of assembling a commissure assembly, comprising:
Example 188. The method of any example herein, particularly example 187, wherein the step of suturing comprises passing the suture through portions of the tab disposed over opposite sides of the adjustment arm.
Example 189. A method for adjusting the tension of leaflets of a prosthetic valve, comprising:
Example 190. The method of any example herein, particularly example 189, wherein the step of placing the prosthetic valve within the valve holder, comprises a step of expanding the prosthetic valve against an annular holder body of the valve holder.
Example 191. The method of any example herein, particularly any one of examples 189 to 190, wherein each adjustable commissure support comprises a single adjustable arm, wherein the pinion gears comprise primary pinion gears meshed with the driver gear, wherein the step of coupling comprises engaging the driving heads of the driving rods extending from the primary pinion gears with the engagement portions of the single adjustable arms of the adjustable commissure supports, and wherein the step of rotating comprises rotating the driver gear to facilitate rotation of the primary pinion gears meshed therewith.
Example 192. The method of any example herein, particularly any one of examples 189 to 190, wherein each adjustable commissure support comprises two adjustable arms, wherein the pinion gears comprise primary pinion gears meshed with the driver gear, and secondary pinion gears meshed with the primary pinion gears but not with the driver gear, wherein the step of coupling comprises engaging the driving head of the driving rod extending from each primary pinion gear with one adjustable arm of an adjustable commissure support, and engaging the driving head of the driving rod extending from the secondary pinion gear meshed the with the primary pinion gear, with the other adjustable arm of the same adjustable commissure support, and wherein the step of rotating comprises rotating the driver gear to facilitate rotation of the primary pinion gears and the secondary pinion gears in opposite rotational directions.
Example 193. A method for adjusting the tension of leaflets of a prosthetic valve, comprising:
Example 194. The method of any example herein, particularly example 193, wherein the step of disengaging the driving heads comprises pulling the driving heads proximally away from the engagement portions.
Example 195. The method of any example herein, particularly example 194, wherein the step of disengaging the driving heads comprises pulling adjustment sleeves that are disposed over the adjustment arms in a proximal direction.
Example 196. The method of any example herein, particularly example 194, wherein the step of disengaging the driving heads comprises simultaneously pulling the adjustment arms with adjustment sleeves disposed thereover.
Example 197. The method of any example herein, particularly any one of examples 193 to 196, wherein the step of rotating the adjustment arms comprises rotating each couple of adjustment arms engaged with two adjustable arms that extend from a single support base, in opposite rotational directions.
Example 198. The method of any example herein, particularly any one of examples 193 to 197, further comprising a step of retrieving the delivery apparatus.
It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. No feature described in the context of an embodiment is to be considered an essential feature of that embodiment, unless explicitly specified as such.
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. Rather, the scope 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/US2021/041720, filed Jul. 15, 2021, which claims benefit of U.S. Provisional Application No. 63/052,107, filed on Jul. 15, 2020, the contents of each of which are herein incorporated by reference in their entirety.
| Number | Date | Country | |
|---|---|---|---|
| 63052107 | Jul 2020 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | PCT/US2021/041720 | Jul 2021 | WO |
| Child | 18096728 | US |
